Medicine | Popular Science https://www.popsci.com/category/medicine/ Awe-inspiring science reporting, technology news, and DIY projects. Skunks to space robots, primates to climates. That's Popular Science, 145 years strong. Thu, 02 May 2024 15:00:00 +0000 en-US hourly 1 https://wordpress.org/?v=6.2.2 https://www.popsci.com/uploads/2021/04/28/cropped-PSC3.png?auto=webp&width=32&height=32 Medicine | Popular Science https://www.popsci.com/category/medicine/ 32 32 Orangutan observed using a plant to treat an open wound https://www.popsci.com/environment/ape-treat-wound-plant/ Thu, 02 May 2024 15:00:00 +0000 https://www.popsci.com/?p=613341
Close up of orangutan
How the great ape first learned to use the plant is still unclear. Deposit Photos

It's the first time this behavior was observed in the animal world.

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Close up of orangutan
How the great ape first learned to use the plant is still unclear. Deposit Photos

Observers have documented multiple animal species using plants for self-medicinal purposes, such as great apes eating plants that treat parasitic infections or rubbing vegetation on sore muscles. But a wild orangutan recently displayed something never observed before—he treated his own open wound by activating a plant’s medical properties using his own spit. As detailed in a study published May 2 in Scientific Reports, evolutionary biologists believe the behavior could point toward a common ancestor shared with humans.

The discovery occurred within a protected Indonesian rainforest at the Suaq Balimbing research site. This region, currently home to roughly 150 critically endangered Sumatran orangutans, is utilized by an international team of researchers from the Max Planck Institute of Animal Behavior to monitor the apes’ behavior and wellbeing. During their daily observations, cognitive and evolutionary biologists noticed a sizable injury on the face of one of the local males named Rakus. Such wounds are unsurprising among the primates, since they frequently spar with one another—but then Rakus did something three days later that the team didn’t expect.

Endangered Species photo

After picking leaves off of a native plant known as an Akar Kuning (Fibraurea tinctoria), well-known for its anti-inflammatory, anti-fungal, and antioxidant properties, as well as its use in traditional malaria medicines, Rakus began to chew the plant into a paste. He then rubbed it directly on his facial injury for several minutes before covering it entirely with the mixture. Over the next few days, researchers noted the self-applied natural bandage kept the wound from showing signs of infection or exacerbation. Within five days, the injury scabbed over before healing entirely.

Such striking behavior raises a number of questions, particularly how Rakus first learned to treat his face using the plant. According to study senior author Caroline Schuppli, one possibility is that it simply comes down to “individual innovation.”

“Orangutans at [Suaq] rarely eat the plant,” she said in an announcement. “However, individuals may accidentally touch their wounds while feeding on this plant and thus unintentionally apply the plant’s juice to their wounds. As Fibraurea tinctoria has potent analgesic effects, individuals may feel an immediate pain release, causing them to repeat the behavior several times.”

[Related: Gorillas like to scramble their brains by spinning around really fast.]

If this were the case, it could be that Rakus is one of the few orangutans to have discovered the benefits of Fibraurea tinctoria. At the same time, adult orangutan males never live where they were born—they migrate sizable distances either during or after puberty to establish new homes. So it’s also possible Rakus may have learned this behavior from his relatives, but given observers don’t know where he is originally from, it’s difficult to follow up on that theory just yet.

Still, Schuppli says other “active wound treatment” methods have been noted in other African and Asian great apes, even when they aren’t used to disinfect or help heal an open wound. Knowing that, “it is possible that there exists a common underlying mechanism for the recognition and application of substances with medical or functional properties to wounds and that our last common ancestor already showed similar forms of ointment behavior.”

Given how much humans already have in common with their great ape relatives, it’s easy to see how this could be a likely explanation. But regardless of how Rakus knew how to utilize the medicinal plant, if he ever ends up scrapping with another male orangutan again, he’ll at least know how to fix himself up afterwards.

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The bombastic 19th-century anti-vaxxer who fueled Montreal’s smallpox epidemic https://www.popsci.com/health/19th-century-anti-vaxxer/ Tue, 23 Apr 2024 12:00:00 +0000 https://www.popsci.com/?p=611830
Alexander Milton Ross
Misinformation about diseases is a timeless human challenge. Images: A page out of the 19th-century Anti-Vaccinator magazine; naturalist and anti-vaccination activist Alexander Milton Ross. MIT Press Reader

Alexander Milton Ross's tale reveals striking similarities to today's vaccine hesitancy and the enduring challenge of combating misinformation campaigns.

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Alexander Milton Ross
Misinformation about diseases is a timeless human challenge. Images: A page out of the 19th-century Anti-Vaccinator magazine; naturalist and anti-vaccination activist Alexander Milton Ross. MIT Press Reader

This article was originally featured on MIT Press Reader.

This article is excerpted from Sabrina Sholts’s book “The Human Disease: How We Create Pandemics, from Our Bodies to Our Beliefs.“

“VACCINATE! VACCINATE!! VACCINATE!!! THERE’S MONEY IN IT!!! TWENTY THOUSAND VICTIMS!!! will be Vaccinated within the next ten days in this City under the present ALARM!!! That will put $10,000 into the pockets of the Medical Profession.” In case all the exclamation points and capitalized letters didn’t do the trick, Alexander Milton Ross embellished his poster with a large drawing of a police officer restraining a mother while Death vaccinated her child. It was terrifying, no doubt. For extra emphasis, the police officer held a piece of paper that read “Vaccination for the Jenner-ation of Disease,” a reference to the English physician Edward Jenner, who developed and promoted vaccination.

In 1885, Canada had no greater adversary of smallpox vaccination than Ross, an Anglo-Canadian physician and naturalist whose medical training was informed by the sanitary movement of the 19th century. Opposed to the germ theory emerging in Europe (that same year, Louis Pasteur’s rabies vaccine was announced to the world), Ross believed that smallpox was a filth disease and its only antidote was cleanliness. And though it’s true that smallpox could spread through soiled fabrics used by smallpox patients (such as bedding and clothing), its primary route of transmission was virus-laden respiratory droplets. The real danger thus lay in close and prolonged contact with smallpox patients, independent of how clean the setting was.

Vaccination, in Ross’s mind, was poisonous. He wanted everyone to know it too. Besides papering the city of Montreal with antivaccination posters and pamphlets, writing letters to newspapers and professional journals, and founding a magazine called the Anti-Vaccinator, he formed the Canadian Anti-Vaccination League as part of an international antivaccination crusade. “Though Police and the Profession cry Vaccinate! Vaccinate!! Vaccinate!!! and people in thousands follow their blind leaders, — I still say, DON’T,” Ross urged in a circular that he distributed throughout the city.

Ross believed that smallpox was a filth disease and its only antidote was cleanliness.

At the time, Montreal was struggling to fight off the largest epidemic of smallpox that it would ever face. For almost a century, smallpox vaccination had been widely used to prevent the disease, but many of the city’s inhabitants had refused the procedure.

Some of the holdouts were surely persuaded by Ross and his English-only propaganda. But most of the unvaccinated population and therefore the bulk of the cases consisted of French Canadians. To convince them of the evils of vaccination, French Canadian physician Joseph Emery Coderre formed the first Canadian antivaccination society in Montreal and published numerous antivaccination pamphlets in French in the 1870s. His ardent antivaccination views fed the fervor of protesters who attacked the city council in 1875, halting efforts to enact mandatory smallpox vaccination in Montreal and leaving the city vulnerable to devastating disease 10 years later. When compulsory vaccination was attempted again in 1885, the riot was even bigger. Shortly thereafter, Coderre and colleagues created an antivaccination journalL’Antivaccinateur canadien-français, the Francophone counterpart to Ross’s magazine.

Antivaccination poster in 1885. Created by Alexander Milton Ross during the smallpox epidemic in Montreal, the text accuses medical doctors of profiting from smallpox vaccination and urges citizens to refuse it, while the image suggests that the smallpox vaccine is deadly. Source: Michael Bliss, “Plague: The Story of Smallpox in Montreal” (Toronto: HarperCollins, 1991).
Antivaccination poster in 1885. Created by Alexander Milton Ross during the smallpox epidemic in Montreal, the text accuses medical doctors of profiting from smallpox vaccination and urges citizens to refuse it, while the image suggests that the smallpox vaccine is deadly. Source: Michael Bliss, “Plague: The Story of Smallpox in Montreal” (Toronto: HarperCollins, 1991).

The misinformation promoted by Ross, Coderre, and their contemporaries should be familiar to anyone with a social media account in the 21st century. First off, they downplayed the threat of the epidemic in Montreal. Francophone newspapers wrote little about it, except to dismiss the panic, while Ross stressed in one of his pamphlets, “CAUTION. Do not be alarmed by the smallpox.” Simultaneously, they insisted that vaccination was the true danger. In the Anti-VaccinatorRoss explained that vaccination didn’t prevent smallpox and actually infected people with the smallpox virus, along with other equally lethal pathogens. Coderre likewise insisted that victims of vaccination were everywhere. His writings included pages of individuals whom he believed were sickened or killed by the vaccine, either from contracting smallpox or some other malady such as gangrene and syphilis.

And then, of course, they spouted conspiracy theories. Provaccination doctors were accused of profiting from the practice, as Ross broadcast in his poster. One French Canadian doctor, in an open letter to Coderre published by the medical journal L’Union Médicale du Canada in 1875, laid out the same charge. He also perceived another conspiracy among English physicians in particular, attributing their advocacy of the smallpox vaccine to nationalistic conflicts of interest given that English physician Jenner was associated with it. Coderre replied in agreement, affirming that English doctors and public vaccinators practiced vaccination par intérêt — purely out of self-interest. These beliefs were consistent with a general distrust of the Anglophone elite, whose vaccines were seen as both poisoning and punishing the French Canadian community, which mostly lived in overcrowded tenements in the poorest quarters of the city.

Their arguments are reminiscent of misinformation during subsequent epidemics and pandemics, all the way up to the present. It’s also noteworthy that while Ross thought sanitation was the answer to smallpox, Francophone newspapers printed recipes for at-home remedies, such as buckwheat root or mixtures of zinc sulfate, digitalis, and sugar. (A cure was never found for smallpox before its eradication, and treatments generally consisted of cleaning the wounds and easing the pain of the ill.) These ideas are akin to the popularization in the United States of non-FDA-approved treatments for COVID-19, such as ivermectin (an antiparasitic agent used to treat patients with certain worm infections and head lice) and hydroxychloroquine (a medication used for malaria and autoimmune conditions such as lupus and rheumatoid arthritis), which many people learned about through the internet, social media, and celebrity testimonials. Despite early hopes, neither of them turned out to be effective for preventing or treating COVID-19. But without any specific treatments for COVID-19 until long into the pandemic, it’s not surprising that some patients opted to take risks with these unproven remedies rather than heed public health warnings against them. Some physicians even participated in misinformation about the efficacy of these drugs and continued to prescribe them for COVID-19. And although many studies haven’t observed that ivermectin and hydroxychloroquine cause serious adverse effects in COVID-19 patients, they can still be dangerous if the patients forgo evidence-based COVID-19 treatments or vaccination against SARS-CoV-2 as a result of using them, as editors at the Journal of the American Medical Association pointed out last year.

To be fair, smallpox vaccination was far from perfectly safe in the late 19th century. Even Jenner himself couldn’t explain how his vaccine worked, and some methods (such as passing infectious material directly from the arm of a vaccinated person to an unvaccinated one) undoubtedly had the potential to introduce other infections. There were also some cases where children may have died as a result of faulty vaccine preparations. Furthermore, even if the vaccination was successful, it didn’t guarantee complete or lifelong immunity. Antivaccinationists, though, were incorrect about the risks and effects of the vaccine. And their dishonesty, at least in the case of Ross, raised questions about their own motives.

One State Board of Health report called him “a monster in human form who desired that a most terrible disease should decimate his patrons, that he might grow fat on their putrid bodies.”

Ross, the bombastic pamphleteer, was apparently a hypocrite at heart. In October 1885, while the smallpox epidemic was still raging in Montreal, he boarded a train to Toronto. As reported afterward by the Gazette, a medical inspector at the Ontario border asked Ross to show proof of recent smallpox vaccination, either in the form of a certificate or scar. It was a standard policy for travelers, but Ross tried his best to get out of it. Then when he couldn’t produce a certificate, he reluctantly took off his coat, rolled off his sleeve, and revealed “three perfect vaccination marks” on his arm. One of them was relatively fresh, and the others were from infancy and childhood, according to Ross. The article about the incident offered little by way of commentary, except to note the long history of doctors who believed in the efficacy of vaccination but opposed the practice since they would lose a source of revenue if smallpox declined. (Similarly, during the COVID-19 pandemic, the Fox News channel was a top broadcaster of vaccine skepticism in the United States, even though nearly all of the corporation’s employees were vaccinated.)

The news about Ross reached the United States, where it was met with outrage among the public health community. One State Board of Health report called him “a monster in human form who desired that a most terrible disease should decimate his patrons, that he might grow fat on their putrid bodies.”

By the end of the smallpox epidemic in Montreal in 1886, more than 3,200 people had died from the disease. The city lost almost 2 percent of its total population in 1885 alone, and more than 3 percent of its French Canadian community. Most of them were children. There were numerous blunders that helped the disease spread, as historian Michael Bliss recounts in his book “Plague: How Smallpox Devastated Montreal,” and the large population of unvaccinated children created by fear and ignorance was a major factor. Every one of the deaths could have been prevented, Bliss emphasizes. Unfortunately, it wasn’t until the disease ran out of unvaccinated or otherwise vulnerable hosts that the epidemic finally waned.

Misinformation about diseases is a timeless human challenge. Some opinions offered about the antivaccination riot in Montreal, such as in a New York Times editorial in 1875, ring a bell 150 years later. With shock that anyone would harbor such an absurd preconception against vaccination, a triumph of modern medicine, the editorial lamented that “in spite of all our boasted progress, curious revelations of popular ignorance and superstition are constantly showing us how little progress has been made.” But after laying blame on the fortune tellers in large cities, the quacks in medicine that flourished everywhere, and even the scientific research and scholarly writings that went above the heads of the public, there was still optimism: “When knowledge is more evenly distributed, there will be less of this fantastic and ignorant prejudice.”

Evenly distributed knowledge? That sounds a lot like the internet to me.


Sabrina Sholts is the curator of biological anthropology at the Smithsonian’s National Museum of Natural History, where she developed the major exhibit “Outbreak: Epidemics in a Connected World.” She is the author of “The Human Disease,” from which this article is excerpted.

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After 100 years, new guidelines propose rules for common food allergy treatment https://www.popsci.com/health/food-allergy-treatment/ Mon, 08 Apr 2024 13:19:18 +0000 https://www.popsci.com/?p=609792
shelled and unshelled peanuts on a table
Oral immunotherapy attempts to desensitize patients to common allergens, including eggs, milk, and peanuts. Deposit Photos

A new study aims to help clinicians standardize care and improve outcomes for their patients.

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shelled and unshelled peanuts on a table
Oral immunotherapy attempts to desensitize patients to common allergens, including eggs, milk, and peanuts. Deposit Photos

Food allergies are a growing health and safety risk, with the Centers for Disease Control and Prevention (CDC) estimating that about 1 in 3 children in the United States are affected. To help combat this, physicians use a technique called oral immunotherapy to try to build a child’s tolerance to some common food allergens. Now, a study published April 8 in the Journal of Allergy and Clinical Immunology aims to create the first set of international guidelines for clinicians to use to help families and clinicians succeed in this sometimes life saving process. These guidelines are not currently mandatory and aim to help standardize care to improve patient outcomes. 

“These families must provide the therapy every single day. That’s why these guidelines are so important,” Douglas Mack, study co-author and a clinical professor at McMaster University in Canada, said in a statement. “Safety can be optimized to make sure that they understand what they’re taking on, while ensuring that they are aware of the kinds of side-effects that can be dangerous.”

What is oral immunotherapy?

Oral immunotherapy involves giving very small amounts of a food allergen like peanuts, walnuts, milk, or egg to a child with a documented allergy. The amount is then gradually increased in an attempt to build up the body’s tolerance and the process has been used for over a century. In 1908, oral immunotherapy helped desensitize a 13-year-old patient with an egg allergy. In that study, the starting dose was 1/10,000th of an egg every day. After six months, the patient could safely eat eggs. More recent analysis found that it can induce desensitization in most patients who are allergic to peanuts, milk, and egg by 76.9 percent

This process is not without risks, as it is administered every day at home to children by their caregivers, which requires caregivers to act like “amateur medical professionals” by observing a child’s reactions and deciding if medical treatment is necessary. These new guidelines are intended to help prepare families and standardize the approach to the process. 

[Related: Babies who grow up around pets may be less likely to develop food allergies.]

“Families need to learn about food allergies, anaphylaxis, immunotherapy, how to safely dose the food, which things to look out for, when to treat, and when to contact the medical team,” Julia Upton, a clinical immunologist at the Hospital for Sick Children in Toronto, Canada, told DW. Upton is not a co-author of the new study. 

What’s in the new guidelines?

A panel of 36 international oral immunotherapy experts worked together to craft a detailed standardized consent form and topics to discuss with families. This includes mentioning that oral immunotherapy is not a cure, that asthma should be controlled before starting the therapy, and stress all caregivers must understand how the process works. This should ensure that all parents and caregivers know the risks and benefits, and alternative treatments if they are unwilling to take on oral immunotherapy. 

“If they decide they want to do it after following these guidelines, they’re prepared for what they’re getting into,” said Mack. “They understand the risks and most importantly, it makes it safer because they can anticipate the challenges. This protocol sets the standard moving forward.”

The guidelines also stresses adequate adult supervision of dosing before treatment begins and that potential risk factors to the patient should be identified before the therapy begins. Some of these risk factors include uncontrolled asthma in the patient and an unwillingness for the caregiver to use epinephrine in case of a reaction. Failure to administer epinephrine in the event of a severe allergic reaction can result in death. 

[Related: A peanut allergy patch is making headway in trials with toddlers.]

The team estimates that as many as one-third of patients were not getting any degree of counseling or preparation before starting the treatment. It took about 30 to 60 minutes for a clinicing to provide adequate counseling about all of the risks and benefits of oral immunotherapy, according to the study. 

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Experimental treatment grows livers from lymph nodes https://www.popsci.com/health/grow-second-liver/ Tue, 02 Apr 2024 16:56:47 +0000 https://www.popsci.com/?p=609126
an yellow-ish bag of liver cells in a suspension.
A cell solution with hepatocytes in a suspension. These liver cells are part of an experimental treatment for those with end-stage liver disease. LyGenesis

The first human trial is underway and could transform organ donation if successful.

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an yellow-ish bag of liver cells in a suspension.
A cell solution with hepatocytes in a suspension. These liver cells are part of an experimental treatment for those with end-stage liver disease. LyGenesis

A team of scientists is attempting to grow a new liver inside of a human using lymph nodes. While this sounds like science fiction, Pittsburgh-based biotech company LyGenesis announced that a volunteer has received an injection of liver cells from a living donor that could turn one of their lymph nodes into a second and functioning liver.

The experimental procedure took place in Houston on March 25. It is part of a Phase 2a clinical trial that will test this treatment in 12 adults who have end-stage liver disease (ESLD). This illness occurs when the liver is damaged beyond repair, primarily due to chronic liver disease or acute liver failure. Over 50,000 Americans die of chronic liver disease every year. 

Patients with ESLD typically require a liver transplant, but roughly 10,000 people are currently on the waiting list in the United States alone. In 2021, a record of 9,234 liver transplants were performed in the US, according to the federal government’s Scientific Registry of Transplant Recipients. LyGensis hopes that this procedure will create the growth of enough liver tissue that patients won’t need a transplant. 

[Related: Swiss researchers kept a donor liver healthy for a remarkable 68 hours.]

“This therapy will potentially be a remarkable regenerative medicine milestone by helping patients with ESLD grow new functional ectopic livers in their own body,” LyGenesis co-founder and CEO Dr. Michael Hufford said in a statement. “If our study is successful and we obtain FDA approval, our allogeneic cell therapy could enable one donated liver to treat many dozens of ESLD patients, which could help to tilt the current organ supply-demand imbalance in favor of patients.”

The technique has been in the works for over a decade. It takes liver cells–or hepatocytes–from a donated organ and injects them into the lymph nodes that are found all over the body. In the lymph nodes, the liver cells will hopefully divide, grow, and develop blood vessels. It targets a group of lymph nodes in the abdomen that are connected to the liver via a system of veins.

According to MIT Technology Review, LyGenesis has tested their approach in mice and pigs, finding that the cells can flourish and form an additional liver that will take over the function of an animal’s failing organ. Chief scientific officer of LyGenesis and University of Pittsburgh pathologist Dr. Eric Lagasse published a study in 2020 that found the pigs regained their liver function following the injections. They also noted that the more severe the damage to the pig’s original liver, the bigger the second livers grew. The pig’s body may be able to recognize the more healthy tissue and give the new liver more responsibilities. 

In the trial procedure, the doctors threaded a thin flexible tube down the end of the patient’s throat through the digestive tract, according to Wired. They then used an ultrasound to identify one of the target lymph nodes and put 50 million hepatocytes into it.

[Related: Surgeons complete first-ever gene-edited pig kidney transplant.]

“LyGenesis’ cell therapy platform represents a truly remarkable potential commercial opportunity and may be transformative for chronic liver failure patients who do not have access to a donor liver,” LyGenesis investor Justin Briggs from Prime Movers Lab said in a statement. “Their use of an endoscopic ultrasound as a low risk and low cost route of cell therapy administration is another way this pioneering technology could provide patients with access to life-saving therapies and address complex medical challenges by upending transplant medicine.”

The results won’t be available for a few months and the team will be monitoring how many cells are required to grow a liver that is large enough to filter blood and produce bile. If it works, it could mean a major change for the treatment of liver disease, which affects roughly 4.5 million people in the United States. 

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This cap is a big step towards universal, noninvasive brain-computer interfaces https://www.popsci.com/technology/bci-wearable-cap/ Mon, 01 Apr 2024 18:48:27 +0000 https://www.popsci.com/?p=608932
Users wearing BCI cap to play video game
Machine learning programming enables a much more universal training process for wearers. University of Texas at Austin

Users controlled a car racing video game with the device, no surgery needed.

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Users wearing BCI cap to play video game
Machine learning programming enables a much more universal training process for wearers. University of Texas at Austin

Multiple brain-computer interface (BCI) devices can allow now users to do everything from control computer cursors, to translate neural activity into words, to convert handwriting into text. While one of the latest BCI examples appears to accomplish very similar tasks, it does so without the need for time-consuming, personalized calibration or high-stakes neurosurgery.

AI photo

As recently detailed in a study published in PNAS Nexus, University of Texas Austin researchers have developed a wearable cap that allows a user to accomplish complex computer tasks through interpreting brain activity into actionable commands. But instead of needing to tailor each device to a specific user’s neural activity, an accompanying machine learning program offers a new, “one-size-fits-all” approach that dramatically reduces training time.

“Training a BCI subject customarily starts with an offline calibration session to collect data to build an individual decoder,” the team explains in their paper’s abstract. “Apart from being time-consuming, this initial decoder might be inefficient as subjects do not receive feedback that helps them to elicit proper [sensorimotor rhythms] during calibration.”

To solve for this, researchers developed a new machine learning program that identifies an individual’s specific needs and adjusts its repetition-based training as needed. Because of this interoperable self-calibration, trainees don’t need the researcher team’s guidance, or complex medical procedures to install an implant.

[Related: Neuralink shows first human patient using brain implant to play online chess.]

“When we think about this in a clinical setting, this technology will make it so we won’t need a specialized team to do this calibration process, which is long and tedious,” Satyam Kumar, a graduate student involved in the project, said in a recent statement. “It will be much faster to move from patient to patient.”

To prepare, all a user needs to do is don one of the extremely red, electrode-dotted devices resembling a swimmer’s cap. From there, the electrodes gather and transit neural activity to the researcher team’s newly created decoding software during training. Thanks to the program’s machine learning capabilities, developers avoided the time-intensive, personalized training usually required for other BCI tech to calibrate for each individual user.  

Over a five-day period, 18 test subjects effectively learned to mentally envision playing both a car racing game and a simpler bar-balancing program using the new training method. The decoder was so effective, in fact, that wearers could train on both the bar and racing games simultaneously, instead of one at a time. At the annual South by Southwest Conference last month, the UT Austin team took things a step further. During a demonstration, volunteers put on the wearable BCI, then learned to control a pair of hand and arm rehabilitation robots within just a few minutes.

So far, the team has only tested their BCI cap on subjects without motor impairments, but they plan to expand their decoder’s abilities to encompass users with disabilities.

“On the one hand, we want to translate the BCI to the clinical realm to help people with disabilities,” said José del R. Millán, study co-author and UT professor of electrical and computer engineering. “On the other, we need to improve our technology to make it easier to use so that the impact for these people with disabilities is stronger.” Millán’s team is also working to incorporate similar BCI technology into a wheelchair.

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This implant will tell a smartphone app when you need to pee https://www.popsci.com/health/bladder-sensor-implant/ Mon, 25 Mar 2024 19:00:00 +0000 https://www.popsci.com/?p=607873
Bladder sensor next to smartphone displaying its app
The sensor responds to a bladder's natural expansions and contractions throughout the day. Northwestern University

The stretchy, wireless sensor could keep patients with bladder issues informed in real-time.

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Bladder sensor next to smartphone displaying its app
The sensor responds to a bladder's natural expansions and contractions throughout the day. Northwestern University

For people dealing with spina bifida, paralysis, and various bladder diseases, determining when to take a bathroom break can be an issue. To help ease the frequent stress, researchers at Northwestern University have designed a sensor array that attaches to the bladder’s exterior wall, enabling it to detect its fullness in real time. Using embedded Bluetooth technology, the device then transmits its data to a smartphone app, allowing users to monitor their bodily functions without far less discomfort and guesswork.

The new tool, detailed in a study published today in the Proceedings of the National Academy of Sciences (PNAS), isn’t only meant to prevent incontinence issues. Lacking an ability to feel bladder fullness extends far beyond the obvious inconveniences—for millions of Americans dealing with bladder dysfunctions, not knowing when to go to the bathroom can cause additional organ damage such as regular infections and kidney damage. To combat these issues, the new medical device mirrors the bladder’s own elasticity. 

[Related: This drug-delivery soft robot may help solve medical implants’ scar tissue problem.]

“The key advance here is in the development of super soft, ultrathin, stretchable strain gauges that can gently wrap the outside surface of the bladder, without imposing any mechanical constraints on the natural filling and voiding behaviors,” John Rogers, study co-lead and professor of material sciences and biomedical engineering at Northwestern University, said in a statement.

As a bladder fills with urine, its expansion stretches out the sensor material, which in turn wirelessly sends data to a patient’s smartphone app. This also works as the organ contracts after urination, providing users with the real-time data throughout the day’s ebbs and flows. In small animal lab tests, the battery-free device could accurately monitor a bladder for 30 days, while the implant lasted in non-human primates as long as 8 weeks.

“Depending on the use case, we can design the technology to reside permanently inside the body or to harmlessly dissolve after the patient has made a full recovery,” regenerative engineer and study co-lead Guillermo Ameer said on Monday

Researchers believe their device could reduce the need for uncomfortable, infection-prone catheters, as well as limiting the use of more invasive, in-patient bladder monitoring procedures. But why stop there?

The team is also testing a separate, biodegradable “patch” using a patient’s own stem cells. Called a pro-regenerative scaffold (PRS), the new material also expands and contracts alongside the bladder’s movements while encouraging the growth of new organ cells. New tissue remains in place as the patch dissolves, allowing for faster, more effective healing possibilities. Researchers hope to one day combine their PRS work alongside their wireless monitoring sensors.

“This work brings us closer to the reality of smart regenerative systems, which are implantable pro-regenerative devices capable of probing their microenvironment, wirelessly reporting those findings outside the body… and enabling on-demand or programmed responses to change course and improve device performance or safety,” said Ameer.

For even more restored functionality, the team believes their sensors could eventually incorporate additional technology to stimulate urination on demand using the smartphone app. Taken as a whole, the trio of medical advances could one day offer a far less invasive, comfortable, and effective therapy for patients dealing with bladder issues. 

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Surgeons complete first-ever gene-edited pig kidney transplant https://www.popsci.com/health/gene-edited-pig-kidney-transplant/ Fri, 22 Mar 2024 19:00:00 +0000 https://www.popsci.com/?p=607565
surgeons in an operating room
After around four hours of tense operating, surgeons in the room reportedly said they saw the transplanted kidney producing urine, a key sign the procedure was a success. DepositPhotos

Doctors say ‘the real hero’ is the 62-year-old patient from Massachusetts who underwent the experimental procedure.

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surgeons in an operating room
After around four hours of tense operating, surgeons in the room reportedly said they saw the transplanted kidney producing urine, a key sign the procedure was a success. DepositPhotos

In a world first, surgeons at Massachusetts General Hospital successfully transplanted a genetically modified pig kidney into a person with chronic kidney disease. The historic procedure builds off of decades of research into gene editing of animal organs and could mark an inflection point in efforts to cut down on sometimes fatally lengthy transplant wait times. Recent advances in gene editing technology means procedures like these could become more common. 

The patient, a 62-year-old man from Massachusetts named Richard Slayman, has severe diabetes and hypertension and has been on dialysis for seven years. He eventually received a new kidney from a human donor but it began showing signs of failure after five years. Slayman was on a waiting list for another kidney when his doctors suggested the possibility of receiving an experimental kidney from a gene-edited pig.

“I saw [the transplant] not only as a way to help me, but a way to provide hope for the thousands of people who need a transplant to survive,” Slayman said in a statement. 

The modified pig was engineered by Massachusetts-based biotech firm eGenesis. Scientists used CRISPR gene editing technology to produce a pig with 69 gene modifications. Several of these modifications were meant to remove harmful pig genes that could provoke an immune response from the patent. Human genes were also added to the pig to improve the kidney’s compatibility and lessen the likelihood of the human body rejecting it. 

After around four hours of tense operating, surgeons in the room reportedly said they saw the transplanted kidney producing urine, a key sign the procedure was a success. The room filled with applause and cheers. 

“This represents a new frontier in medicine and demonstrates the potential of genome engineering to change the lives of millions of patients globally suffering from kidney failure,” eGenesis CEO Mike Curtis said in a statement

Why are scientists interested in gene-editing animal organs?

Scientists are hopeful that transplanting animal organs into humans, a practice called “xenotransplantation,” could one day supplement human organ transplants and cut down on lengthy transplant wait times. An estimated 36 million people in the US are affected by chronic kidney disease, 800,000 of which have end stage kidney disease or kidney failure according to the Centers for Disease Control. Once at that stage, patients are often forced to choose between going on a dialysis machine that filters their blood or applying for an organ transplant. Over 103,000 people in the US are currently on organ transplant wait list according to the Health Resource and Services Administration (HRSA). 

But lengthy wait times and a limited supply of able organ donors means many of those patients never end up receiving a transplant. The HRSA estimates 17 people die everyday while waiting for a new organ. Those lengthy wait times and lack of donors has also helped fuel an organ black market. 

Potential animal organ transplants aren’t just limited to kidneys. Surgeons at the University of Pennsylvania, for example, successfully implanted a gene-modified pig liver into a brain-stem dead person in 2022. Not long after that surgeons from the University of Maryland Medical Center implanted pig hearts into two fatally-ill patients. Though those two surgeries were successful, their end effect was limited. Both patients reportedly died less than two months after the procedures. Human immune systems react violently to organs from other species and try to reject them, an obstacle which makes these procedures particularly challenging.  

“If it were easy, we’d be doing it by now, but it’s not,” MGH Transplant Center Director Joren Madsen said in a statement. “The barrier to pig xenotransplantation is formidable.” 

Still, researchers are hopeful advancements in gene editing could lead to longer lasting benefits. Surgeons have previously transplanted genetically modified kidneys and livers to baboons. In one case, eGenesis claims a monkey implanted with a gene-edited pig kidney lived for two years following the surgery. Surgeons involved with Slayman’s procedure are similarly hoping his new kidneys could help him live for two more years. The FDA fast tracked approval for his particulate procedure as part of its “compassionate use” program intended for patients nearing the ends of their lives. Wider use of this procedure would require full FDA testing and approval. 

And while the historic procedure is both a feat of scientific and medical prowess, surgeons involved say the real credit belongs to the patient for marching into an unknown territory.

“The real hero today is the patient, Mr. Slayman, as the success of this pioneering surgery, once deemed unimaginable, would not have been possible without his courage and willingness to embark on a journey into uncharted medical territory,” MGH Transplant Center Director Joren C. Madsen said in a statement.

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Neuralink shows first human patient using brain implant to play online chess https://www.popsci.com/technology/neuralink-first-human-video/ Thu, 21 Mar 2024 16:30:00 +0000 https://www.popsci.com/?p=607341
Neuralink logo on smartphone
Neuralink's first human patient is a 29-year-old quadriplegic man from Texas. Deposit Photos

Elon Musk previously said his brain-computer interface company implanted the device in January.

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Neuralink logo on smartphone
Neuralink's first human patient is a 29-year-old quadriplegic man from Texas. Deposit Photos

The first human patient to reportedly receive Neuralink’s wireless brain-computer interface (BCI) implant appeared to demonstrate the device’s early capabilities during a company livestream to X on Wednesday night. In late January, Elon Musk publicly stated that the experimental medical procedure was completed, but neither he nor his controversial medical startup had offered evidence of the results until yesterday evening’s 9-minute video.

Neuralink’s first volunteer is 29-year-old Noland Arbaugh from Texas, who dislocated his C4 and C5 vertebrae during a diving accident in 2016, permanently paralyzing him below the shoulders. During the livestream, Arbaugh appears to be playing online chess as a Neuralink BCI implant translates his brain activity into actionable computer inputs.

“If y’all can see the cursor moving around the screen, that’s all me,” he says at one point while highlighting a chess piece. “It’s pretty cool, huh?” According to Arbaugh, the key to successfully employing his new implant involved learning how to mentally differentiate between intentional and attempted movement—i.e, brain activity expressing the desire to move as opposed to activity which literally controls motor functions. “From there, I think it just became intuitive to me to start imagining the cursor moving,” Arbaugh continued, likening the feeling to “using the Force” from Star Wars.

Neuralink’s BCI is implanted using a robotic surgeon that subcutaneously connects the device’s microscopic wiring to a patient’s brain. Once installed, the hardware supposedly cannot be seen externally, and recharges wireless from “outside via a compact, inductive charger,” according to Neuralink’s website. Musk has repeatedly stated his hopes Neuralink will ultimately allow users to connect to the internet, smartphones, and computers through a line of upgradable, reversible BCI implants—and that he intends to one day receive the procedure himself.

“Long-term, it is possible to shunt the signals from the brain motor cortex past the damaged part of the spine to enable people to walk again and use their arms normally,” Musk claimed in a reply to Neuralink’s Wednesday evening post.

During the livestream hosted by Neuralink engineer Bliss Chapman, Arbaugh also described independently playing video games like the turn-based strategy game Civilization 6, which often entails more complex user inputs. Before the implant, Arbaugh says he frequently required assistance from his parents or a friend to play such games. Now, however, he says he has been able to do so for as long as eight hours and that the biggest impediment is simply waiting for the Neuralink’s battery to recharge.

[Related: Elon Musk alleges Neuralink completed its first human trial implant.]

“It’s not perfect. We have run into some issues,” Arbaugh concedes at one point, although he does not elaborate on the hurdles. “I don’t want people to think this is the end of the journey. There’s still a lot of work to be done.”

“We have more work to do. We have a lot to learn about the brain here,” agreed Chapman.

Neuralink is far from the first company to develop and install BCI implants, with the first successful commercial procedure dating back to 2010. Similar devices have since converted imagined handwriting into text, as well as thoughts into words. One competitor’s implant has also enabled users to browse the web as well as conduct online shopping and banking since 2019.

But it’s unclear if the reveal of Neuralink’s first human participant will assuage critics’ concerns regarding the company’s research record. Less than a day after Neuralink announced it would begin screening human volunteers for its multiyear ​​Precise Robotically Implanted Brain-Computer Interface (PRIME) Study last September, Wired released a damning exposé detailing graphic accounts of lab animal abuse during research. At the time, Wired’s coverage was one in a string of similar investigations into Musk’s company, including internal complaints of “hack job” surgical procedures resulting in over 1,500 animal deaths since 2018. The reports have since prompted multiple federal regulatory reviews and human trial delays.

As Wired also noted this week, Neuralink has not registered its PRIME Study on ClinicalTrials.gov, the federal documentation site for human medical studies, so information like how many human subjects Neuralink is seeking, where its procedures are taking place, or how its results will be assessed are not publicly available.

Still, Arbaugh encouraged people to consider applying to Neuralink’s ongoing PRIME Study, saying “there’s nothing to be afraid of” about the “super easy” procedure which he says has resulted in no cognitive impairments for him. Chapman, meanwhile, stated last night that additional updates on both Neuralink’s and Arbaugh’s progress will be released in the coming days.

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Silicon Valley wants to deploy AI nursebots to handle your care https://www.popsci.com/technology/ai-nurse-chatbots-nvidia/ Tue, 19 Mar 2024 18:30:00 +0000 https://www.popsci.com/?p=607152
Woman talking with nurse chatbot on iPad
Hippocratic AI is using Nvidia GPUs to power its nurse chatbot avatars. Nvidia / Hippocratic AI / YouTube

Medical startup Hippocratic AI and Nvidia say it's all about the chatbots' 'empathy inference.'

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Woman talking with nurse chatbot on iPad
Hippocratic AI is using Nvidia GPUs to power its nurse chatbot avatars. Nvidia / Hippocratic AI / YouTube

The medical startup Hippocratic AI and Nvidia have announced plans to deploy voice-based “AI healthcare agents.” In demonstration videos provided Monday, at-home patients are depicted conversing with animated human avatar chatbots on tablet and smartphone screens. Examples include a post-op appendectomy screening, as well as a chatbot instructing someone on how to inject penicillin. Hippocratic’s web page suggests providers could soon simply purchase its nursebots for less than $9/hour to handle such tasks, instead of paying an actual registered nurse $90/hour, Hippocratic claims. (The average pay for a registered nurse in the US is $38.74/hour, according to a 2022 U.S. Bureau of Labor Statistics’ occupational employment statistics survey.)

A patient’s trust in AI apparently is all about a program’s “seamless, personalized, and conversational” tone, said Munjal Shah, Hippocratic AI co-founder and CEO, in the company’s March 18 statement. Based on their internal research, people’s ability to “emotionally connect” with an AI healthcare agent reportedly increases “by 5-10% or more” for every half-second of conversational speed improvement, dubbed Hippocratic’s “empathy inference” engine. But quickly simulating all that worthwhile humanity requires a lot of computing power—hence Hippocratic’s investment in countless Nvidia H100 Tensor Core GPUs.

AI photo

“Voice-based digital agents powered by generative AI can usher in an age of abundance in healthcare, but only if the technology responds to patients as a human would,” said Kimberly Powell, Nvidia’s VP of Healthcare, said on Monday

[Related: Will we ever be able to trust health advice from an AI?]

But an H100 GPU-fueled nurse-droid’s capacity to spew medical advice nearly as fast as an overworked healthcare worker is only as good as its accuracy and bedside manner. Hippocratic says it’s also got that covered, of course, and cites internal surveys and beta testing of over 5,500 nurses and doctors voicing overwhelming satisfaction with the AI as proof. When it comes to its ability to avoid AI’s (well documented) racial, gendered, and age-based biases, however, testing is apparently still underway. And in terms of where Hippocratic’s LLM derived its diagnostic and conversational information—well, that’s even vaguer than their mostly anonymous polled humans.

In the company’s white paper detailing Polaris, its “Safety-focused LLM Constellation Architecture for Healthcare,” Hippocratic AI researchers say their model is trained “on a massive collection of proprietary data including clinical care plans, healthcare regulatory documents, medical manuals, drug databases, and other high-quality medical reasoning documents.” And that’s about it for any info on that front. PopSci has reached out to Hippocratic for more specifics, as well as whether or not patient medical info will be used in future training.

In the meantime, it’s currently unclear when healthcare companies (or, say, Amazon, for that matter) can “augment their human staff” with “empathy inference” AI nurses, as Hippocratic advertises. The company did note it’s already working with over 40 “beta partners” to test AI healthcare agents on a wide gamut of responsibilities, including chronic care management, wellness coaching, health risk assessments, pre-op outreach, and post-discharge follow-ups.

It’s hard to envision a majority of people ever preferring to talk with uncanny chat avatars instead of trained, emotionally invested, properly compensated healthcare workers. But that’s not necessarily the point here. The global nursing shortage remains dire, with recent estimates pointing to a shortage of 15 million health workers by 2030. Instead of addressing the working conditions and wage concerns that led unions representing roughly 32,000 nurses to strike in 2023, Hippocratic claims its supposed cost-effective AI solution is the “only scalable way” to close the shortfall gap—a scalability reliant on Nvidia’s H100 GPU.

The H100 is what helped make Nvidia one of the world’s most lucrative, multi trillion-dollar companies, and the chips still support many large language model (LLM) AI supercomputer systems. That said, it’s now technically Nvidia’s third most-powerful offering, following last year’s GH200 Grass Hopper Super Chip, as well as yesterday’s simultaneous reveal of a forthcoming Blackwell B200 GPU. Still, at roughly $30,000-to-$40,000 per chip, the H100’s price tag is reserved for the sorts of projects valued at half-a-billion dollars–projects like Hippocratic AI.

But before jumping at the potential savings that an AI labor workaround could provide the healthcare industry, it’s worth considering these bots’ energy costs. For reference, a single H100 GPU requires as much power per day as the average American household.

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The decades-long quest for lab-grown organs https://www.popsci.com/science/lab-grown-organs/ Mon, 04 Mar 2024 14:00:00 +0000 https://www.popsci.com/?p=605137
"Now we're groing human life in a laboratory" from the Popular Science June 1962 issue.
"Now we're groing human life in a laboratory" from the Popular Science June 1962 issue. Popular Science

After more than half a century, researchers are still trying to figure out how to engineer individualized organs in a lab.

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"Now we're groing human life in a laboratory" from the Popular Science June 1962 issue.
"Now we're groing human life in a laboratory" from the Popular Science June 1962 issue. Popular Science

From cities in the sky to robot butlers, futuristic visions fill the history of PopSci. In the Are we there yet? column we check in on progress towards our most ambitious promises. Read more from the series here.

Decades before the first “test tube babies,” there were “biological cradles.” In fact, artificial wombs, which may soon be entering human trials for high-risk premature babies, got their start as far back as the early 1960s when researchers developed devices and methods to grow human embryos in a lab for as long as 50–60 days.

“This is not the relatively simple tissue culture,” Popular Science associate editor Joan Steen explained in June 1962, “where highly specialized cells like bone marrow or liver are kept growing in glass dishes fed by nutrient broths.” 

Steen visited the lab of a surgeon in Italy, Daniele Petrucci, who had been developing embryos for their potential to support organ transplants. “This is growing the whole organism from scratch,” Steen wrote. “Taking the microscopic human egg cell and attempting, against all odds, to fertilize it and keep it alive for a long time.” 

Much has changed in embryo research since 1962. From growing and printing synthetic organs to cellular reprogramming to artificial wombs, what scientists have learned from embryo studies has been breathtaking. But we still can’t sustain human embryos outside a womb for very long, and, more than a half century on, Petrucci’s vision of lab-grown organs remains mostly experimental. 

Ectogenesis, the process of growing a human from conception to birth outside a body, is still the stuff of science fiction, ominously portrayed by Aldous Huxley in Brave New World, where lab-grown babies are engineered into social castes. In part, that’s because, by the 1970s, ethical concerns about embryo research led to funding restrictions, laws, and research regulations that have limited what scientists can explore. But it’s also because we have a long way to go in understanding the complex and nuanced placental interchange between the fetus and the pregnant person’s body.

“The challenge is the placenta does the work of a whole bunch of body systems during gestation,” says Michelle Oyen, Director of the Center for Women’s Health Engineering at Washington University in St. Louis. “You can’t just grow something independent of the vascular system, the lymph system, the nervous system—you need to have all of those connections, and that’s why it starts to become so complicated.”

The first successful “test tube baby,” Louise Brown, was born in 1978, paving the way for in vitro fertilization (IVF) as a solution for infertile couples. Since then, at least 12 million babies have been born using IVF, according to the International Committee for Monitoring Assisted Reproductive Technologies. But “test tube babies” are not actually grown in a lab for more than a handful of days before the fertilized egg is transferred to a uterus or frozen and stored for future transfer. (The procedure has recently become the focus of legal scrutiny after the US Supreme Court overturned Roe v. Wade in June 2022 and the Alabama Supreme Court ruled in February 2024 that frozen embryos are children.)

Brown’s birth signaled just how far scientists had come with embryo research, which set off alarms. A year later, in 1979, the US Department of Health Education and Welfare implemented the 14-day rule, prohibiting the growth of embryos in a lab beyond 14 days, citing ethical concerns. The restriction was widely adopted globally, limiting researchers’ ability to study later stages of embryonic development or to grow embryos for organ transplants. 

As a result, human embryo and fetal development between 14 days and viability (roughly 22–24 weeks) is a kind of black box that scientists have been trying to explore in other ways. At the Center for Women’s Health Engineering, Oyen applies engineering tools and techniques to study that crucial developmental period about which so much remains unknown. 

“I do a lot of computational modeling and image-based analysis,” Oyen explains. She also uses organ-on-a-chip models, which involves growing miniature tissues, or organoids—like placentas, lungs, hearts, even brains—on the type of chip that resembles a computer chip, carved with microchannels used to deliver fluids necessary to maintain the tissue while also providing direct means to monitor tissue growth. Organoids have been useful for drug testing and organ-specific research but have yet to advance to the point of providing regenerated organs for replacement therapy.

[ Related: A ‘brain organoid’ biochip displayed serious voice recognition and math skills ]

To grow organoids—and organs—requires some form of stem cell, generally an embryonic stem cell, an adult stem cell, or an adult stem cell that has been reprogrammed to an embryonic state, also known as an induced pluripotent stem cell (iPSC). 

Embryonic stem cells are the most versatile; they start as blank slates, capable of developing into any type of cell, such as brain, skin, or liver. It’s their versatility that makes them so attractive to scientists seeking regenerative cures. The field of epigenetics, which can be traced back to the 1940s, explores the extrinsic factors that influence how an embryonic stem cell develops. 

It wasn’t until 1998 that embryonic stem cells were successfully isolated by scientist James Thomson at the University of Wisconsin in Madison. Thomson’s discovery led to further restrictions on embryonic stem cell research, especially in the US.

By the early 2000s, the quest for human embryonic stem cell lines to fuel research led to therapeutic cloning, which enabled scientists to develop embryonic stem cell lines without relying on fertilization or surplus eggs from IVF clinics. Using such approved embryonic stem cell lines, researchers have been able to grow artificial embryos, or embryoids, that don’t require a separate sperm and egg. Of course, the 14-day rule still applies, which means the embryoid needs to be destroyed before it can develop further, although exceptions have been suggested since embryoids lack potential to develop into a functional fetus. 

The restrictions imposed between the 1970s and early 2000s helped spur other approaches to stem cell research, not for the goal of growing humans artificially, rather with an eye toward understanding the very early stages of human development and toward regenerative medicine, the kind Petrucci envisioned—using stem cells to grow or regrow organs, cure or prevent diseases, and even reverse aging. 

Adult stem cells, for instance, are not bound by the same research restrictions that govern embryonic stem cells. Adult stem cells, like the kind found in cord blood (yes, stem cells in infant cord blood are considered “adult”) and bone marrow, have regenerative properties, but their potential is limited by their advanced developmental stage. They cannot be induced to develop into any other cell unless they are “reprogrammed” first.

Cellular reprogramming, coaxing one cell type to convert to another by reprogramming it into an embryonic state, was first attempted in the 1980s and later advanced by Nobel Prize recipient Shinya Yamanaka. Today, scientists can revert mature cells, like skin cells, back to their embryonic, or pluripotent state (such cells are known as induced pluripotent stem cells, or iPSCs), enabling them to start fresh, regrowing into different tissue, like liver cells. 

Beyond the obvious and significant ethical concerns, Petrucci’s model of growing organs via an embryo—a very small clone with perfectly matched tissue—would have been seriously inefficient, like building an entire house just to use one room.

3D bioprinting, however, using stem cell-based bioinks, shows promise. Researchers have successfully printed a variety of human organs such as kidneys, blood vessels, bones, muscle and skin tissue, and even a functioning heart.

[ Related: Scientists have 3D bioprinted functioning human brain tissue ]

But Oyen thinks it will be a while before growing or bioprinting organs will be reliable, pointing out that “you can’t engineer things without having the science. And that means this black box of early development is a real problem in trying to correctly and successfully recapitulate development of an organ.” She notes that there have been modest commercial successes like growing skin tissue for skin grafts, but “getting to that point where we’re using individualized stem cells from individual people to make a tissue-engineered graft is still in the future.”

It has been more than half a century since Petrucci shared with Popular Science his efforts to grow embryos in a lab for the purposes of human organ replacement. Since then, embryo research has pushed the boundaries of science, ethics, and our social conscience. While significant progress has been made in understanding the behavior and potential of embryonic stem cells (and other stem cells), we still can’t engineer organs reliably.

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CDC recommends Americans 65 and over get additional COVID-19 vaccine https://www.popsci.com/health/covid-19-vaccine-booster-time-65/ Fri, 01 Mar 2024 14:06:03 +0000 https://www.popsci.com/?p=605101
A doctor puts a bandage on the upper arm of a senior citizen.
The most recent vaccines are about 54 percent effective at preventing symptomatic illness from COVID-19. Deposit Photos

The virus remains a serious threat, particularly to this age group.

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A doctor puts a bandage on the upper arm of a senior citizen.
The most recent vaccines are about 54 percent effective at preventing symptomatic illness from COVID-19. Deposit Photos

The Centers for Disease Control and Prevention (CDC) is recommending that Americans ages 65 and older get a second dose of this season’s COVID-19 vaccine. Under this new guidance, an additional dose of the vaccine can be given at least four months after the previous shot. 

[Related: mRNA vaccine innovators win the Nobel Prize in medicine.]

“Most COVID-19 deaths and hospitalizations last year were among people 65 years and older,” CDC Director Dr. Mandy Cohen said in a statement. “An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk.”

A CDC report published in February said that the 2023-2024 COVID-19 vaccine is about 54 percent effective at preventing symptomatic COVID-19, compared with those who had not received the latest vaccine. The CDC estimates that only 22 percent of adults in the US have gotten a COVID-19 booster this season. A little over 40 percent of Americans ages 65 and over have gotten the 2023-2024 shot.

The CDC’s independent Advisory Committee on Immunization Practices voted 11-1 with one abstention on the new recommendations. A subgroup of advisers suggested softer language in the recommendation that would have suggested that older adults “may” get a second dose of the vaccine instead of “should.” These committee members felt that this language shift would have given clinicians added flexibility and also takes growing vaccine hesitancy into account. 

According to The Washington Post, Camille Kotton of Massachusetts General Hospital in Boston pushed for stronger language so that the recommendations would be more clear to patients. Kotton said that using the word “may” is “too soft, especially for the most vulnerable,” and that many Americans remain unaware that they should be getting a COVID-19 vaccine.

CDC data shows that older adults have been the most vulnerable to COVID-19’s most severe effects. Hospitalizations related to the virus have been consistently higher in this age group than others, with about two-thirds of COVID-19 hospitalizations occurring in patients over 65. Senior citizens also make up the largest proportion of those who have died in the hospital from COVID-19 and have the highest numbers to fatalities after being discharged from the hospital. 

[Related: How to check your measles vaccination status amid outbreak.]

COVID-19 remains a threat. The CDC reports that there were roughly 20,000 new hospital admissions and 2,000 COVID-19 deaths per week as of February 17. Even when reported cases were at their lowest in summer 2023, about 500 Americans were still losing their lives to COVID-19 every week. 

Updates vaccines are available at most pharmacies and at doctors offices. 

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Watch the plasma fly in space capsule’s dramatic fall to Earth https://www.popsci.com/science/space-capsule-reentry-video/ Thu, 29 Feb 2024 21:45:00 +0000 https://www.popsci.com/?p=605067
Varda W-1 capsule reentry video screenshot
After 8 months in orbit, Varda's first reusable capsule made a safe return to Earth on Feb. 21. Varda / YouTube

Varda's W-1 spent 8 months in orbit before recording its entire trip home.

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Varda W-1 capsule reentry video screenshot
After 8 months in orbit, Varda's first reusable capsule made a safe return to Earth on Feb. 21. Varda / YouTube

It took less than 30 minutes for Varda Space Industries’ W-1 capsule to leave its orbital home of eight months and plummet back to Earth. Such a short travel time not only required serious speed (around 25 times the speed of sound), but also the engineering wherewithal to endure “sustained plasma conditions” while careening through the atmosphere. In spite of these challenges, Varda’s first-of-its-kind reentry mission was a success, landing back on the ground on February 21. To celebrate, the company has released video footage of the capsule’s entire descent home.

Check out W-1’s fiery return below—available as both abbreviated and extended cuts:

Installed on a Rocket Lab Photon satellite bus, Varda’s W-1 capsule launched aboard a SpaceX Falcon 9 rocket June 12, 2023. Once in low-Earth orbit, its mini-lab autonomously grew crystals of the common HIV treatment drug ritonavir. Manufacturing anything in space, let alone pharmaceuticals, may seem like overcomplicating things, but there’s actually a solid reason for it. As Varda explains on its website, processing materials in microgravity may benefit from a “lack of convection and sedimentation forces, as well as the ability to form more perfect structures due to the absence of gravitational stresses.”

In other words, medication crystals like those in ritonavir can be grown larger and more structurally sound than is typically possible here on Earth.

Although the experiment wrapped up in just three weeks, Varda needed to delay reentry plans multiple times due to issues securing FAA approval. After finally getting the go-ahead, the W-1 readied for its return earlier this month. All the while, it contained a video camera ready to capture its dramatic fall.

Private Space Flight photo

After ejecting from its satellite host, W-1 begins a slightly dizzying spin that provides some incredible shots from hundreds of miles above Earth. At about the 12-minute mark, the planet’s gravitational pull really takes hold—that’s when things begin to heat up for Varda’s experimental capsule.

[Related: First remote, zero-gravity surgery performed on the ISS from Earth (on rubber)]

At Mach 25 (around 17,500 mph), exterior friction between the craft and Earth’s atmosphere becomes so intense that it literally splits the chemical bonds of nearby air molecules. This results in a dazzling show of sparks and plasma before W-1’s parachute deploys to slow and stabilize its final descent. Finally, the capsule can be seen touching down in a remote region of Utah, where it was recovered by the Varda crew.

Next up will be an assessment of the space-grown drug ingredients, and additional launches of capsules for more manufacturing experiments. While they might not all include onboard cameras to document their returns, W-1’s is plenty mesmerizing enough.

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How to check your measles vaccination status amid outbreak https://www.popsci.com/health/check-measles-vaccination-status/ Tue, 27 Feb 2024 17:00:00 +0000 https://www.popsci.com/?p=604520
A syringe with a measles, mumps, and rubella (MMR) vaccine next to its packaging.
Two doses of the Measles, Mumps, and Rubella (MMR) vaccine are about 97 percent effective at preventing measles. Paul Hennessy/NurPhoto via Getty Images

There have been 35 reported cases of the highly-contagious disease so far this year.

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A syringe with a measles, mumps, and rubella (MMR) vaccine next to its packaging.
Two doses of the Measles, Mumps, and Rubella (MMR) vaccine are about 97 percent effective at preventing measles. Paul Hennessy/NurPhoto via Getty Images

The Florida Department of Health is investigating eight cases of measles due to an outbreak of the highly contagious disease in a school in Broward County. Six of the previously known cases are in students from Manatee Bay Elementary School, in the town of Weston, near Fort Lauderdale. New data from the state shows two more cases this week in Broward County, one case in a child under five and another in a child between five and nine-years-old. 

[Related: Some vaccinated adults may not be protected against measles.]

The United States officially got rid of endemic measles in 2000. However, the illness has begun to circulate in the US and around the world due to widespread misinformation and challenges from the COVID-19 pandemic

These new cases come just a few days after Florida Surgeon General Doctor Joseph Ladapo contradicted both medical and federal guidance on when students can return to school and how to contain the spread of this preventable disease. 

What is measles?

Measles is a highly contagious respiratory disease. It is estimated that 90 percent of non-immune people exposed to an infected individual will contract the virus. Symptoms may include, cough, runny nose, watery eyes, fever, and red spots that look like a rash. It is spread through coughs and sneezes and can linger in a room for up to two hours. 

In some rare cases, measles may lead to pneumonia, encephalitis, or death. It can also weaken a patient’s immune system, making fighting future illnesses more difficult. 

How do I know if I’ve been vaccinated?

There is no one national organization that maintains vaccination records in the US. According to the CDC, a good first step is to ask parents or guardians for copies of vaccination records. These are sometimes kept in baby books, photo albums, or filing cabinets since most vaccinations are given during early childhood. 

[Related: What to know about polio boosters, oral vaccines, and your medical history records.]

If you do not have a copy at home, contact your pediatrician or doctor’s office. Depending on your age, this could take a while since records may be in deep storage. Your high school or college may also have medical records still on file. Older adults also may need additional doses of the measles vaccine

You can also reach out to your state’s health department, since some have registries called Immunization Information Systems. These may even include adult vaccines, like those for shingles or yearly flu and COVID-19 shots. 

If you have moved to the US from another country, vaccination information may have also been collected during the visa process. Paperwork from the medical exam may have proof of certain vaccinations.

A last step is making an appointment with a doctor or pharmacy to have a blood titer test to see what level of immunity you have to measles, chicken pox, and other diseases. This is also where you can set up an appointment for a booster or first round of vaccinations. Those vaccinated against measles are about 97 percent protected against the virus. 

What is happening in Florida?

Typically, doctors and public health officials recommend children who are not vaccinated for measles isolate for a period of 21 days if they are exposed to the virus at school. In the letter sent to parents and guardians at Manatee Bay Elementary School, Dr. Ladapo, said it was up to individual families to determine when their children can return to school.

“Because of the high likelihood of infection, it is normally recommended that children stay home until the end of the infectious period,” the letter dated February 20 read. However, Ladapo continued saying that the state “is deferring to parents or guardians to make decisions about school attendance. This recommendation may change as epidemiological investigations continue.”

[Related: The deadliest viruses in human history, from COVID to smallpox.]

This break from traditional protocol has some physicians in the area concerned. According to family physician and public health specialist Doctor George Rust, most students in Florida public schools have been vaccinated, but that number has started to decline in recent years.

“There’s the possibility that children who are not immunized and who are susceptible to measles are attending school, potentially getting measles and then transmitting it to other kids,” Rust told CNN. “Now, you’ve, on the one hand, allowed parents to make their own choices for the child who was not immunized, but you’ve also taken away some choices for those parents who may feel that their children should be protected.”

Why is measles having a resurgence?

Florida is one of 11 states who have seen cases this year alone. According to The Centers for Disease Control and Prevention (CDC), there have been 35 measles cases reported in 15 states already this year. By comparison, there were 58 reported cases in 2023 alone. 

The current resurgence can be tied to vaccine hesitancy and misinformation surrounding the Measles, Mumps, and Rubella (MMR) vaccine and a struggle in vaccinating young children due to the COVID-19 pandemic. The CDC warned physicians to “stay alert for measles” in January, as more cases emerged particularly among unvaccinated children and adolescents. 

In the US, about 92 percent of children had received their MMR vaccine by the age of two in 2023. However, this is below the federal target for herd immunity of 95 percent vaccinated. 

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Gene-edited pigs immune to deadly virus could arrive on farms by next year https://www.popsci.com/environment/gene-edited-pigs/ Fri, 23 Feb 2024 19:00:00 +0000 https://www.popsci.com/?p=604074
Pigs in sty at factory farm
Animal rights groups say the solution remains factory farming reforms, not genetic editing. Deposit Photos

A company used CRISPR to make the animals resistant to deadly diseases, but watchdogs say viruses are not the problem.

The post Gene-edited pigs immune to deadly virus could arrive on farms by next year appeared first on Popular Science.

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Pigs in sty at factory farm
Animal rights groups say the solution remains factory farming reforms, not genetic editing. Deposit Photos

US farmers are closer than ever to raising genetically edited pigs immune to one of the animal’s deadliest diseases. But while millions of dollars could be saved with livestock impervious to highly virulent, diverse strains of porcine reproductive and respiratory syndrome (PRRS), animal rights groups maintain the cutting-edge idea isn’t an ethical solution, but yet another industrial farming stopgap.

PRRS is a dynamic, often fatal virus that affects millions of pigs around the world and costs farmers as much as $2.7 billion each year. Current vaccines only reduce symptom severity, and the antibiotics used to treat an infected pig’s weakened immune system can exacerbate the development of other resistant bacterial diseases.

[Related: Scientists swear their lab-grown ‘beef rice’ tastes ‘pleasant’]

Genus, an international breeding company, believes the best way to solve this major issue is to engineer pigs that are incapable of contracting the virus. As highlighted in a recent New Scientist profile, Genus researchers succeeded through CRISPR gene editing technology. By removing a portion of protein called CD163, the disease cannot infect a pig’s cells and allows the animal to remain “healthy and indistinguishable in appearance and behavior,” according to a Genus research study recently published in The CRISPR Journal.

Doing so isn’t an easy task. Just one-fifth of Genus-bred piglets possessed the desired gene—and even then, only within certain body cells due to a biological condition known as mosaicism. Meanwhile, some lab livestock may have lacked CD163, but at the cost of other unwanted genome changes.

Because of such issues, experts have spent years attempting to create a healthy, gene-edited animal. Genus says it has so far bred hundreds of PRRS-immune pigs, and expects to receive approval from the US Food and Drug Administration to begin public sales as soon as next year. Meanwhile, regulatory approvals are also being pursued globally in countries including China and Mexico—both of which import large amounts of US pork.

But according to factory farming critics and animal rights advocates, the real issue isn’t livestock disease susceptibility—it’s the livestock’s living conditions. According to the international welfare nonprofit World Animal Protection, farm stock receives three-quarters of global antibiotic supplies each year in an attempt to stave off disease, treat infections, and promote faster growth rates. Doing so is directly linked to the rise in treatment-resistant superbugs, which are more likely to leap between animals to humans within a factory farm’s cramped, poorly ventilated environments.

“Crowding animals into stressful, unhealthy conditions has led to the emergence of new virulent pathogens and diseases,” Gene Baur, President and Co-Founder of the animal rights group Farm Sanctuary, said in an email to PopSci. “Rather than developing genetically engineered animals who can survive the horrific cruelties of factory farming, agribusiness should focus instead on addressing the conditions that create these diseases in the first place.”

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First remote, zero-gravity surgery performed on the ISS from Earth (on rubber) https://www.popsci.com/technology/remote-surgery-robot-iss/ Fri, 16 Feb 2024 15:00:00 +0000 https://www.popsci.com/?p=602988
Surgeon using spaceMIRA remote surgery tool on ISS
A team of surgeons used rubber bands to represent human tissue aboard the ISS. Credit: Virtual Incision

Surgeons in Nebraska controlled spaceMIRA from 250 miles below the ISS as it cut through simulated human tissue.

The post First remote, zero-gravity surgery performed on the ISS from Earth (on rubber) appeared first on Popular Science.

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Surgeon using spaceMIRA remote surgery tool on ISS
A team of surgeons used rubber bands to represent human tissue aboard the ISS. Credit: Virtual Incision

Researchers successfully completed the first remote, zero-gravity “surgery” procedure aboard the International Space Station. Over the weekend, surgeons based at the University of Nebraska spent two hours testing out a small robotic arm dubbed the Miniaturized In Vivo Robotic Assistant, or spaceMIRA, aboard the ISS as it orbited roughly 250 miles above their heads. 

But don’t worry—no ISS astronauts were in need of desperate medical attention. Instead, the experiment utilized rubber bands to simulate human skin during its proof-of-concept demonstration on Saturday.

[Related: ‘Odie’ is en route for its potentially historic moon landing.]

Injuries are inevitable, but that little fact of life gets complicated when the nearest hospital is a seven-month, 300-million-mile journey away. But even if an incredibly skilled doctor is among the first people to step foot on Mars, they can’t be trained to handle every possible emergency. Certain issues, such as invasive surgeries, will likely require backup help. To mitigate these problems in certain situations, remote controlled operations could offer a possible solution.

Designed by Virtual Incision, a startup developing remote-controlled medical tools for the world’s most isolated regions, spaceMIRA weights only two pounds and takes up about as much shelf-space as a toaster oven. One end of its wandlike is topped with a pair of pronglike arms—a left one to grip, and right one to cut.

[Related: 5 space robots that could heal human bodies—or even grow new ones ]

Speaking with CNN on Wednesday, Virtual Incision cofounder and chief technology officer Shane Farritor explained spaceMIRA’s engineering could offer Earthbound the hands and eyes needed to perform “a lot of procedures minimally invasively.”

On February 10, a six-surgeon team in Lincoln, Nebraska, took spaceMIRA (recently arrived aboard the ISS via a SpaceX Falcon 9 rocket) for its inaugural test drive. One arm gripped a mock tissue sample, and the other used scissors to dissect specific portions of the elastic rubber bands.

spaceMIRA prototype on desk
A version of the spaceMIRA (seen above) traveled to the ISS earlier this month. Credit: Virtual Incision

While researchers deemed the experiment a success, surgeons noted the difficulty in accounting for lag time. Communications between Earth and the ISS are delayed about 0.85 seconds—while a minor inconvenience in most circumstances, even milliseconds can mean a matter of life or death during certain medical emergencies. Once on the moon, Artemis astronauts and NASA headquarters will deal with a full 1.3 seconds of delay between both sending and receiving data. On Mars, the first human explorers will face a full hour of waiting after firing off their message, then waiting for a response. Even taking recent laser communications breakthroughs into consideration, patience will remain a virtue for everyone involved in future lunar and Mars expeditions.

This means that, for the time being, devices like spaceMIRA are unlikely to help in split second medical decisions. But for smaller issues—say, a lunar resident’s stitch up after taking a tumble, such medical tools could prove invaluable for everyone involved. In the meantime, Virtual Incision’s remote controlled equipment could still find plenty of uses here on Earth.

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Scientists have 3D bioprinted functioning human brain tissue https://www.popsci.com/science/3d-printed-brain-tissue/ Mon, 05 Feb 2024 22:00:00 +0000 https://www.popsci.com/?p=601526
Illustration of 3D printed brain tissue culture with 25nm scale
The new brain tissue culture production offers more precise customization for researchers. Yan et al. / UW-Madison

A new method for assembling neuron cultures horizontally instead of vertically helps solve for a longstanding issue.

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Illustration of 3D printed brain tissue culture with 25nm scale
The new brain tissue culture production offers more precise customization for researchers. Yan et al. / UW-Madison

Scientists have created brain “organoids” for years, but there are limitations to the tiny, lab-grown cultures. One of the most frustrating issues is a lack of control over their design, which often limits an organoid’s functionality and use. Although researchers long suspected 3D-printing could offer a solution, the workaround has so far proven difficult and ineffective. A new production breakthrough, however, could solve the longstanding barrier, and one day offer new ways of exploring treatment for diseases such as Parkinson’s and Alzeheimer’s.

As detailed in the new issue of the journal Cell Stem Cell, University of Wisconsin-Madison researchers have developed a novel 3D-printing approach for creating cultures that grow and operate similar to brain tissue. While traditional 3D-printing involves layering “bio-ink” vertically like a cake, the team instead tasked their machine to print horizontally, as if playing dominoes.

Related: A ‘brain organoid’ biochip displayed serious voice recognition and math skills.]

As New Atlas explains, researchers placed neurons grown from pluripotent stem cells (those capable of becoming multiple different cell types) within a new bio-ink gel made with fibrinogen and thrombin, biomaterials involved in blood clotting. Adding other hydrogels then helped loosen the bio-ink to solve for the 3 encountered during previous 3D-printed tissue experiments.

According to Su-Chun Zhang, a research lead and UW-Madison professor of neuroscience and neurology, the resultant tissue is resilient enough to maintain its structure, but also sufficiently malleable to permit adequate levels of oxygen and nutrient intake for the neurons. 

“The tissue still has enough structure to hold together but it is soft enough to allow the neurons to grow into each other and start talking to each other,” Zhang explains in a recent university profile.

Because of their horizontal construction, the new tissue cells formed connections not only within each layer, but across them, as well—much like human neurons. The new structures could interact thanks to producing neurotransmitters, and even created support cell networks within the 3D-printed tissue.

In these experiments, the team printed both cerebral cortex and striatum cultures. Although responsible for very different functions—the former associated with thought, language, and voluntary movement; the latter tied to visual information—the two 3D-printed tissues could still communicate, “in a very special and specific way,” Zhang said.

Researchers believe their technique isn’t limited to creating just those two types of cultures, but hypothetically “pretty much any type of neurons [sic] at any time,” according to Zhang. This means the 3D-printing method could eventually help study how healthy portions of the brain interact with parts affected by Alzheimers, examining cell signal pathways in Downs syndrome, as well as use tissue to test new drugs.

“Our brain operates in networks,” Zhang explained. “We want to print brain tissue this way because cells do not operate by themselves. They talk to each other. This is how our brain works and it has to be studied all together like this to truly understand it.”

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The untapped potential of stem cells in menstrual blood https://www.popsci.com/health/the-untapped-potential-of-stem-cells-in-menstrual-blood/ Mon, 05 Feb 2024 16:00:00 +0000 https://www.popsci.com/?p=601419
Stem cells found in menstrual blood could unlock new therapies and diagnostic tests.
Stem cells found in menstrual blood could unlock new therapies and diagnostic tests. DepositPhotos

Long overlooked, menstrual stem cells could have important medical applications, including diagnosing endometriosis.

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Stem cells found in menstrual blood could unlock new therapies and diagnostic tests.
Stem cells found in menstrual blood could unlock new therapies and diagnostic tests. DepositPhotos

This article was originally featured on Knowable Magazine.

Roughly 20 years ago, a biologist named Caroline Gargett went in search of some remarkable cells in tissue that had been removed during hysterectomy surgeries. The cells came from the endometrium, which lines the inside of the uterus. When Gargett cultured the cells in a petri dish, they looked like round clumps surrounded by a clear, pink medium. But examining them with a microscope, she saw what she was looking for—two kinds of cells, one flat and roundish, the other elongated and tapered, with whisker-like protrusions.

Gargett strongly suspected that the cells were adult stem cells—rare, self-renewing cells, some of which can give rise to many different types of tissues. She and other researchers had long hypothesized that the endometrium contained stem cells, given its remarkable capacity to regrow itself each month. The tissue, which provides a site for an embryo to implant during pregnancy and is shed during menstruation, undergoes roughly 400 rounds of shedding and regrowth before a woman reaches menopause. But although scientists had isolated adult stem cells from many other regenerating tissues—including bone marrow, the heart, and muscle—“no one had identified adult stem cells in endometrium,” Gargett says.

These purple blobs are clones of the stem cells that Caroline Gargett and colleagues identified in menstrual fluid. Each cluster began as a single cell. On the right, a close-up view of one blob, magnified at least 20 times, reveals the tightly packed cells’ whiskery, spindled shapes. CREDIT: K. SCHWAB, C. TAN AND C. GARGETT, THE RITCHIE CENTRE, HUDSON INSTITUTE OF MEDICAL RESEARCH AND MONASH UNIVERSITY DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, MELBOURNE AUSTRALIA
These purple blobs are clones of the stem cells that Caroline Gargett and colleagues identified in menstrual fluid. Each cluster began as a single cell. On the right, a close-up view of one blob, magnified at least 20 times, reveals the tightly packed cells’ whiskery, spindled shapes. CREDIT: K. SCHWAB, C. TAN AND C. GARGETT, THE RITCHIE CENTRE, HUDSON INSTITUTE OF MEDICAL RESEARCH AND MONASH UNIVERSITY DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, MELBOURNE AUSTRALIA

Such cells are highly valued for their potential to repair damaged tissue and treat diseases such as cancer and heart failure. But they exist in low numbers throughout the body, and can be tricky to obtain, requiring surgical biopsy, or extracting bone marrow with a needle. The prospect of a previously untapped source of adult stem cells was thrilling on its own, says Gargett. And it also raised the exciting possibility of a new approach to long-neglected women’s health conditions such as endometriosis.

Before she could claim that the cells were truly stem cells, Gargett and her team at Monash University in Australia had to put them through a series of rigorous tests. First, they measured the cells’ ability to proliferate and self-renew, and found that some of them could divide into about 100 cells within a week. They also showed that the cells could indeed differentiate into endometrial tissue, and identified certain telltale proteins that are present in other types of stem cells.

Gargett, who is now also with Australia’s Hudson Institute of Medical Research, and her colleagues went on to characterize several types of self-renewing cells in the endometrium. But only the whiskered cells, called endometrial stromal mesenchymal stem cells, were truly “multipotent,” with the ability to be coaxed into becoming fat cells, bone cells, or even the smooth muscle cells found in organs such as the heart.

Stem cells from the endometrium can be collected through a biopsy or in menstrual blood. Under the right conditions, they can differentiate into cell types including neurons and cartilage, fat, bone, heart, liver and skin cells.
Stem cells from the endometrium can be collected through a biopsy or in menstrual blood. Under the right conditions, they can differentiate into cell types including neurons and cartilage, fat, bone, heart, liver and skin cells. Credit: Knowable Magazine

Around the same time, two independent research teams made another surprising discovery: Some endometrial stromal mesenchymal stem cells could be found in menstrual blood. Gargett was surprised that the body would so readily shed its precious stem cells. Since they are so important for the survival and function of organs, she didn’t think the body would “waste” them by shedding them. But she immediately recognized the finding’s significance: Rather than relying on an invasive surgical biopsy to obtain the elusive stem cells she’d identified in the endometrium, she could collect them via menstrual cup.

More detailed studies of the endometrium have since helped to explain how a subset of these precious endometrial stem cells — dubbed menstrual stem cells — end up in menstrual blood. The endometrium has a deeper basal layer that remains intact, and an upper functional layer that sloughs off during menstruation. During a single menstrual cycle, the endometrium thickens as it prepares to nourish a fertilized egg, then shrinks as the upper layer sloughs away.

Gargett’s team has shown that these special stem cells are present in both the lower and upper layers of the endometrium. The cells are typically wrapped around blood vessels in a crescent shape, where they are thought to help stimulate vessel formation and play a vital role in repairing and regenerating the upper layer of tissue that gets shed each month during menstruation. This layer is crucial to pregnancy, providing support and nourishment for a developing embryo. The layer, and the endometrial stem cells that prod its growth, also appears to play an important role in infertility: An embryo can’t implant if the layer doesn’t thicken enough.

Endometrial stem cells have also been linked to endometriosis, a painful condition that affects roughly 190 million women and girls worldwide. Although much about the condition isn’t fully understood, researchers hypothesize that one contributor is the backflow of menstrual blood into a woman’s fallopian tubes, the ducts that carry the egg from the ovaries into the uterus. This backward flow takes the blood into the pelvic cavity, a funnel-shaped space between the bones of the pelvis. Endometrial stem cells that get deposited in these areas may cause endometrial-like tissue to grow outside of the uterus, leading to lesions that can cause excruciating pain, scarring and, in many cases, infertility.

Researchers are still developing a reliable, noninvasive test to diagnose endometriosis, and patients wait an average of nearly seven years before receiving a diagnosis. But studies have shown that stem cells collected from the menstrual blood of women with endometriosis have different shapes and patterns of gene expression than cells from healthy women. Several labs are working on ways to use these differences in menstrual stem cells to identify women at higher risk of the condition, which could lead to faster diagnosis and treatment. Menstrual stem cells may also have therapeutic applications. Some researchers working on mice, for example, have found that injecting menstrual stem cells into the rodents’ blood can repair the damaged endometrium and improve fertility.

Other research in lab animals suggests that menstrual stem cells could have therapeutic potential beyond gynecological diseases. In a couple of studies, for example, injecting menstrual stem cells into diabetic mice stimulated regeneration of insulin-producing cells and improved blood sugar levels. In another, treating injuries with stem cells or their secretions helped heal wounds in mice.

Stem cells differ in abilities. Totipotent stem cells are the most powerful: They can form any cell, and even an entire organism. Pluripotent stem cells are almost as versatile, while multipotent stem cells—which include the mesenchymal stem cells in menstrual blood—can make a limited range of cell types. Oligopotent stem cells can make just a few cell types within the same organ or tissue. Unipotent stem cells replace one specific cell type, like sperm or skin cells. Credit: Knowable Magazine
Stem cells differ in abilities. Totipotent stem cells are the most powerful: They can form any cell, and even an entire organism. Pluripotent stem cells are almost as versatile, while multipotent stem cells—which include the mesenchymal stem cells in menstrual blood—can make a limited range of cell types. Oligopotent stem cells can make just a few cell types within the same organ or tissue. Unipotent stem cells replace one specific cell type, like sperm or skin cells. Credit: Knowable Magazine

A handful of small but promising clinical trials have found that menstrual stem cells can be transplanted into humans without adverse side effects. Gargett’s team is also attempting to develop human therapies. She and her colleagues are using endometrial stem cells—those taken directly from endometrial tissue, rather than menstrual blood—to engineer a mesh to treat pelvic organ prolapse, a common, painful condition in which the bladder, rectum or uterus slips into the vagina due to weak or injured muscles.

The condition is often caused by childbirth. Existing treatments use synthetic meshes to reinforce and support weak pelvic tissues. But adverse immune reactions to these materials have led these meshes to be withdrawn from the market. Gargett’s research—so far conducted only in animal models—suggests that using a patient’s own endometrial stem cells to coat biodegradable meshes could yield better results.

Despite the relative convenience of collecting adult multipotent stem cells from menstrual blood, research exploring and utilizing the stem cells’ power—and their potential role in disease—still represents a tiny fraction of stem cell research, says Daniela Tonelli Manica, an anthropologist at Brazil’s State University of Campinas. As of 2020, she found, menstrual stem cell research accounted for only 0.25 percent of all mesenchymal cell research, while bone marrow stem cells represented 47.7 percent.

Manica attributes the slow adoption of menstrual stem cells in part to misogynistic ideas that uteruses are outside the norm, and to reactions of disgust. “There’s certainly something of an ‘ick factor’ associated with menstrual blood,” agrees Victoria Male, a reproductive immunologist at Imperial College London who coauthored an article about uterine immune cells in the 2023 Annual Review of Immunology.

Cultural taboos surrounding menstruation—and a general lack of investment in women’s health research—can make it difficult to get funding, says Gargett. Immunologist Male has faced similar challenges—it was easier to obtain funding when she used to study immune cells in liver transplantation than it is now that she works on immune cells in the uterus, she says.

“If we want more research on menstrual fluid, we need more funding,” says Male, noting that the logistics of collecting menstrual fluid over multiple days can be expensive. For that to happen, “we have to tackle sex and gender bias in research funding.” Through more equitable investments, she and others hope, menstruation will be recognized as an exciting new frontier in regenerative medicine—not just a monthly inconvenience.

This article originally appeared in Knowable Magazine, an independent journalistic endeavor from Annual Reviews. Sign up for the newsletter.

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Elon Musk alleges Neuralink completed its first human trial implant https://www.popsci.com/technology/neuralink-first-human-trial/ Tue, 30 Jan 2024 19:22:09 +0000 https://www.popsci.com/?p=600798
Smartphone showing Elon Musk X profile against Neuralink logo backdrop
Neuralink first solicited its first human trial applicants in September 2023. Jakub Porzycki/NurPhoto via Getty Images

Musk, posting on X, claimed that the volunteer is ‘recovering well,’ but did not offer evidence.

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Smartphone showing Elon Musk X profile against Neuralink logo backdrop
Neuralink first solicited its first human trial applicants in September 2023. Jakub Porzycki/NurPhoto via Getty Images

Elon Musk recently claimed that the first human patient has received a Neuralink brain-computer interface (BCI) implant, but stopped short of offering any substantial additional information or proof. In a series of messages posted on Monday evening to X, his social media platform formerly known as Twitter, Neuralink’s majority owner alleged an anonymous volunteer underwent the company’s experimental procedure on January 28 and “is recovering well” while showing “promising neuron spike detection.” In a separate tweet, Musk also announced the first Neuralink product will be called Telepathy.

Despite the potential company milestone, no other official details have been made available in the nearly 24 hours since Musk’s announcement. At the time of writing, Neuralink’s most recent news update is still an initial solicitation on their official website for human trial volunteers published last fall.

[Related: Neuralink is searching for its first human test subjects.]

Co-founded by Musk in 2016, Neuralink is a tech startup aiming to create BCI implants for a variety of uses. However, its first devices are specifically tailored for physically impaired and paralyzed patients suffering from diseases such ALS to restore motor functions and the ability to communicate. 

Musk, in turn, has repeatedly voiced hopes of designing implants capable of connecting anyone’s brain to smartphones, computers, and the internet. The devices are intended to be completely reversible and ungradable, with Musk likening them to iPhones. In 2022, Neuralink’s “N1” was reportedly the size of a quarter, and employed a robotic surgeon machine to subcutaneously connect microscopic wiring to the brain. Musk has also suggested users could eventually summon Teslas using their Neuralink implants, and stated he plans to eventually receive the implant.

Although the FDA approved Neuralink to begin human trials in September 2023, regulators initially rejected the medical startup’s application earlier that year due to multiple safety concerns. Numerous bombshell reports have accused Musk’s company of conducting horrific “hack job” surgeries, some of which resulted in severe injuries, psychological damage, and the death of over 1,500 lab test animals. A graphic exposé from Wired, for example, described dozens of botched spinal surgeries, severe self-harm behaviors, and fatal infections as a result of sheep, monkeys, and pigs receiving experimental implants. These investigations subsequently prompted multiple ongoing federal probes regarding Neuralink’s potential animal abuse, and improper transportation of hazardous materials.

Neuralink had already fallen far behind Musk’s ambitious timeline goals before word spread of the company’s allegedly troubling strategies. In 2019, for example, the SpaceX and Tesla CEO expressed a desire to receive an FDA greenlight by the end of 2020, only to later blow past a revised 2022 deadline.

If Sunday’s surgery is confirmed outside of Musk’s X posts, Neuralink will only be the latest company to successfully demonstrate human-BCI devices. Guger Technologies unveiled the world’s first BCI in 2010, while numerous other designs have since debuted, including Synchron’s “Stentrode” neuroprosthesis and one from BrainGate allowing a paralyzed man to convert imagined handwriting into text.

“Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal,” Musk tweeted last night.

[Related: Neuralink’s human trials volunteers ‘should have serious concerns,’ say medical experts.]

Musk’s nebulous Monday tweets recall his reportedly impulsive social media habits, a pattern that has earned its share of regulatory fallout. Problematic tweets from Musk in 2018 eventually resulted in an SEC security fraud settlement that included relinquishing his position as Tesla chairman, alongside agreeing to separate $20 million fines levied against him and his company. He is currently appealing the decision, as well as a National Labor Relations Board’s ruling pertaining to alleged union busting threats posted by Musk to Twitter.

It’s unclear why Neuralink has not released any more information supporting Musk’s tweets. Company representatives did not respond to PopSci at the time of writing.

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What’s going on with CRISPR gene editing? https://www.popsci.com/health/what-is-crispr-now/ Fri, 26 Jan 2024 20:00:00 +0000 https://www.popsci.com/?p=600383
Just cutting DNA to bits isn’t a big deal. The special trick that CRISPR systems add is to make those cuts only in precise, targeted spots.
Just cutting DNA to bits isn’t a big deal. The special trick that CRISPR systems add is to make those cuts only in precise, targeted spots. Gregor Fischer/picture alliance via Getty Image

With the first medical therapy approved and systems like CRISPR-Cas showing up in complex cells, there’s a lot happening in the genome editing field.

The post What’s going on with CRISPR gene editing? appeared first on Popular Science.

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Just cutting DNA to bits isn’t a big deal. The special trick that CRISPR systems add is to make those cuts only in precise, targeted spots.
Just cutting DNA to bits isn’t a big deal. The special trick that CRISPR systems add is to make those cuts only in precise, targeted spots. Gregor Fischer/picture alliance via Getty Image

This article was originally featured on Knowable Magazine.

Around the turn of the century, microbiologists at Danisco USA Inc. had a problem: The bacteria they used to make yogurt and cheese were getting infected with viruses. Investigating more deeply, the scientists found that some bacteria possessed a defense system to fight off such viral invaders.

These virus-resistant bacteria carried weird, repetitive collections of DNA letters in their chromosomes—bits of DNA from their encounters with past viruses that the microbes had “saved” in their own genomes. It was a form of molecular memory akin to the way that our own immune system remembers invaders so it can make antibodies against a recurring infection.

In this case, the microbes’ immune system, dubbed CRISPR-Cas, or more casually, just CRISPR, shreds any viral genome that matches the sequences in their molecular memory banks.

The yogurt-makers weren’t looking for biotechnology’s Next Big Tool. They just wanted to preserve the products in their vats. But other scientists soon realized the potential value of CRISPR for their own designs: With some modifications, CRISPR allowed them to cut any genetic sequence they wanted to, greatly easing the challenge of genetic engineering.

CRISPR systems have taken the biotechnology world by storm, nabbing a Nobel Prize and kicking off a new era of gene therapy. In December 2023, the US Food and Drug Administration approved the first CRISPR-based gene-changing treatment: a new gene therapy for the excruciatingly painful blood disorder sickle cell anemia.

“It’s been revolutionary for research,” says Kevin Esvelt, an evolutionary engineer at the MIT Media Lab in Cambridge, Massachusetts. “It’s accelerating all of biotech.”

Traditional gene therapy was tested in the late 20th century, but toxicity and cancer were major setbacks. CRISPR systems were first discovered in bacteria and the technology has now been successfully incorporated into human gene therapy. Credit: Knowable Magazine
Traditional gene therapy was tested in the late 20th century, but toxicity and cancer were major setbacks. CRISPR systems were first discovered in bacteria and the technology has now been successfully incorporated into human gene therapy. Credit: Knowable Magazine

Ever since scientists discovered CRISPR, there’s been a nagging question: Do similar gene-altering systems also occur in animals, plants and fungi—life forms known as eukaryotes, defined by the nucleus in which they store their genetic material?

The answer, now, is a definitive yes, according to a June 2023 paper in the journal Nature, authored by molecular biologist Feng Zhang and colleagues at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts. The team found CRISPR-like DNA-snippers called Fanzors in an odd menagerie of eukaryotic critters, including fungi, algae, amoebae and a clam called the northern quahog (pronounced coe-hog).

Researchers hailed the finding as a fascinating addition to the CRISPR family tree. And the discovery raises more questions: What are Fanzors up to? Can they, too, make a splash in biotechnology? And might Fanzor and CRISPR be the tip of an iceberg’s worth of DNA-slicing systems awaiting discovery?

Here’s some of what we know about microbial CRISPR systems and the Fanzors-come-lately.

What is CRISPR?

Just cutting DNA to bits isn’t a big deal. The special trick that CRISPR systems add is to make those cuts only in precise, targeted spots. This requires two elements: One is a guide to that location, a short piece of RNA that matches the target DNA sequence. The other is a protein, an enzyme to act as the “scissors.” Microbes have evolved a handful of scissor enzymes that make this cut, with names like Cas9 and Cas12.

When microbes are infected by viruses, the microbes collect small pieces of the viral genetic sequences and stow them together in a segment of their genome called CRISPR repeats. The next time that virus comes along, the microbe can use those sequences to create the guide RNAs. It can then use the enzyme scissors to snip up the genetic material of the virus and defend itself.

About half of known bacteria, as well as most of other microbes known as archaea, have CRISPR-Cas systems. Bizarrely, even some viruses have co-opted the CRISPR-Cas machinery, to fight back against microbes. So until the new study, eukaryotes were the only group totally left out of the fun.

In CRISPR-Cas gene editing, the Cas9 enzyme uses associated pieces of RNA to bind to a portion of the DNA genome. The enzyme then breaks both strands of DNA. The cell repairs this break — either imperfectly, creating a broken gene (left), or using a provided DNA template, resulting in a controlled change (right). Credit: Knowable Magazine
In CRISPR-Cas gene editing, the Cas9 enzyme uses associated pieces of RNA to bind to a portion of the DNA genome. The enzyme then breaks both strands of DNA. The cell repairs this break—either imperfectly, creating a broken gene (left), or using a provided DNA template, resulting in a controlled change (right). Credit: Knowable Magazine

What does CRISPR offer biotechnology?

Every living organism uses the same basic DNA code and proteins, so the CRISPR-Cas system can theoretically work in any organism scientists drop it into—though in reality, some tweaking is generally required.

The simplest application is to cut out undesirable DNA. Once the Cas enzyme cuts a target gene, the cell will glue the DNA back together, but imperfectly, creating a broken gene. For some applications, breaking a gene is all that’s needed, and it’s one possible approach to sickle cell gene therapy.

Sickle cell anemia occurs when the body has defective genes for the blood protein hemoglobin. But the body also has a separate hemoglobin gene used only by fetuses. Scientists want to reactivate the effective fetal hemoglobin in adult blood cells. There’s another gene, BCL11A, that keeps the fetal hemoglobin gene turned off. The new FDA-approved treatment uses CRISPR to break BCL11A, allowing the functioning fetal hemoglobin to spin back up in adult cells. The FDA also approved, in January 2024, this treatment for the blood disorder beta thalassemia.

Using a few extra molecular tricks, researchers can also use CRISPR to add a novel genetic sequence or to repair a broken gene.

Scientists are also trialing CRISPR-Cas-based therapies to treat diabetes; a form of amyloidosis; infections, including HIV; and a variety of cancers. And that’s not all. Researchers are applying CRISPR to turn pigs into possible organ donors for people, create better-quality, disease-resistant fruits, and eradicate mosquitoes that transmit malaria.

There are downsides. Breaking a strand of DNA in people is a risky business: If Cas cuts in the wrong place or the repair process goes wrong, the therapy could change the genome in a way that triggers cancer. Thus, many modern CRISPR-based approaches use modified versions of the Cas protein that don’t fully cut the DNA but edit it more subtly and safely.

How was Fanzor discovered?

Fanzor has been “hiding in plain sight,” says David J. Segal, a geneticist at UC Davis who wrote about the new age of genome engineering for the Annual Review of Genomics and Human Genetics in 2013. The Fanzor genes were first described that same year, but no one knew they encoded a Cas-like enzyme.

Weidong Bao, a researcher at the Genetic Information Research Institute in Cupertino, California, coauthored the 2013 Fanzor study. He and his colleague weren’t looking for DNA scissors; they were interested in what are commonly called “jumping genes.” These are DNA sequences that can hop out of one spot in the genome and reinsert themselves somewhere else. The most famous examples of these elements, known formally as transposons, are the jumping genes found to control kernel color in corn—work that led to a Nobel Prize for geneticist Barbara McClintock. In fact, about half of the human genome consists of transposons, but don’t worry: Most are no longer jumpers.

Bao knew that bacterial jumping genes often contain a gene of unknown function called TnpB. He went looking for similar genes and found them in the genomes of more than two dozen eukaryotes, including a fly, yeasts and molds, amoebas and several algae. The researchers named the eukaryotic version of this mysterious gene Fanzor instead of TnpB.

Researchers have found Fanzor genes in a variety of eukaryotic life forms. Clockwise from upper left: the soil-dwelling fungus Spizellomyces punctatus, the alga Guillardia theta, the northern quahog Mercenaria mercenaria and the amoeba Naegleria lovaniensis. CREDIT: M. SAITO ET AL / NATURE 2023
Researchers have found Fanzor genes in a variety of eukaryotic life forms. Clockwise from upper left: the soil-dwelling fungus Spizellomyces punctatus, the alga Guillardia theta, the northern quahog Mercenaria mercenaria and the amoeba Naegleria lovaniensis. CREDIT: M. SAITO ET AL / NATURE 2023

In a 2021 study, Zhang and his colleagues also stumbled onto Fanzor. They were building a CRISPR-Cas family tree, showing how these RNA-guided cutting systems had evolved, so they scanned genes and proteins from diverse organisms for similar components. They discovered that Fanzor is a cousin of the bacterial Cas genes, and that both gene families were descended from TnpB.

Are Fanzor genes involved in DNA-cutting like CRISPR-Cas systems are?

Zhang and colleagues reasoned that if the Fanzor genes and the Cas genes found in CRISPR systems are long-lost cousins, then Fanzor genes might also carry instructions for a protein that can cut DNA. Following that hypothesis further, the Fanzor protein might also use RNA guides to find and cut a specific DNA sequence.

So they tested it out by letting Fanzor genes loose in dishes of human kidney cells. The genes were translated to make Fanzor proteins. Then the scientists introduced guide RNAs to these Fanzor proteins and left them to stew for three days. If the Fanzor protein was a DNA-slicing enzyme, the cell would glue the DNA back together, but imperfectly, creating odd deletions or insertions at the sites matching the guide RNAs. That’s just what the team found.

Yep, Fanzor was a bona fide, RNA-guided, DNA-cutting enzyme.

The TnpB gene is the ancestor of both Cas-based and Fanzor-based DNA-cutting systems. Credit: Knowable Magazine
The TnpB gene is the ancestor of both Cas-based and Fanzor-based DNA-cutting systems. Credit: Knowable Magazine

Will Fanzor complement or supplant CRISPR-Cas in biotech?

Snipping a handful of genes in dishes is a long way from being biotechnology’s next big tool. So far, the best Zhang’s team has been able to do is to cut the target gene site 18.4 percent of the time, and they haven’t even tried to repair a faulty gene with it. That’s not nearly as good as CRISPR-Cas, which has the benefit of the years scientists have spent optimizing the system.

One potential advantage Fanzor has over CRISPR-Cas is its diminutive size. The Cas enzyme, plus a guide RNA, and potentially other needed elements, is a lot to deliver to a cell one wants to modify. Scientists often stuff those ingredients into a benign virus for delivery, but all the components won’t fit into the most commonly used viruses. The shrimpier Fanzor enzyme is a better fit. Still, scientists have already designed miniature versions of the Cas12 and Cas 13 enzymes that can fit into the viruses. So that’s a bit of a draw between the two.

And there’s a potential disadvantage to genetic engineering with Fanzor, says Esvelt. CRISPR-Cas systems usually require the guide RNA to match up with a DNA sequence that’s some 18 to 20 genetic letters, or bases, in length. Chances are, Esvelt calculates, there’s no more than one such perfect lineup in a genome. That means the Cas enzyme is unlikely to chop the genome anywhere except at the target site—good news for safe gene therapy. But Fanzor makes a match with just 15 DNA bases.

There’s a much higher chance, Esvelt says, that the smaller sequence might be repeated multiple times in a genome. Then Fanzor would cut the target site but also the other identical sites, which could spell disaster for gene therapy. Advantage: CRISPR-Cas.

The fact is, CRISPR works “just fine in most organisms,” says Sophien Kamoun, a plant pathologist at the Sainsbury Laboratory in Norwich in the United Kingdom who has reviewed the use of CRISPR to engineer crop plants. But Fanzor might still be useful for scientists working with certain bacteria where Cas enzymes are toxic, suggests Kamoun.

So overall, there’s no reason for most CRISPR-Cas labs to switch. “I’d rather use the thing that we know,” says Segal, who is working on treatments for neurodevelopmental disorders. “There’s enough mystery in what I do that I don’t need to worry about using a new enzyme.”

What do Fanzor systems do naturally?

Still, Fanzor is a very cool biological discovery. “It’s fascinating that there are CRISPR-like systems across so many kingdoms of life,” says Esvelt.

While we know what CRISPR-Cas systems do for microbes, it’s not clear exactly what Fanzor proteins do in nature. Researchers believe they’re somehow partnered with transposons—maybe helping them, or perhaps hitching a ride.

One possibility the Zhang group has considered is that Fanzor might create a defense system for the transposons. After all, a piece of DNA that can spring in and out of the genome, altering the DNA whenever it does so, is usually not good for a cell, so cells might fight back. Such a hypothetical Fanzor-based defense might work like this: A transposon would jump into spots in the genome that have the same genetic sequence that its associated Fanzor likes to cut. By jumping into that site, the transposon destroys the Fanzor target site, protecting the cell’s genome from being cut.

But if the cell were to remove the transposon, it would recreate the Fanzor target site, making its genome once again vulnerable to Fanzor’s snipping action.

In essence, Zhang speculates, the transposon would be telling the cell, “If you get rid of me, I’ll go somewhere else, I’ll make the Fanzor enzyme and it will come back and chop up the site you kicked me out of.” Better, then, to just leave the transposon where it is.

That’s just a possibility, though.

One organism that doesn’t naturally have Fanzors, Zhang says, is humans. But it remains possible that people possess some other, similar DNA-cutting system in the Fanzor-Cas family. Zhang’s group is actively hunting for new ones. “We’re trying to discover as many as possible,” he says.

This article originally appeared in Knowable Magazine, an independent journalistic endeavor from Annual Reviews. Sign up for the newsletter.

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Popular corticosteroid asthma inhaler Flovent was discontinued this month https://www.popsci.com/health/lovent-discontinued-january-2024/ Tue, 02 Jan 2024 19:30:00 +0000 https://www.popsci.com/?p=597075
The packaging for an inhaler called Flovent HFA. Flovent is a popular inhaled corticosteroid that helps keep inflammation in the lungs low and the airways open for people with asthma.
Flovent is a popular inhaled corticosteroid that helps keep inflammation in the lungs low and the airways open for people with asthma. Smith Collection/Gado/Getty Images

A new “authorized generic” version will be available in its place, but experts worry about access.

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The packaging for an inhaler called Flovent HFA. Flovent is a popular inhaled corticosteroid that helps keep inflammation in the lungs low and the airways open for people with asthma.
Flovent is a popular inhaled corticosteroid that helps keep inflammation in the lungs low and the airways open for people with asthma. Smith Collection/Gado/Getty Images

On January 1, pharmaceutical company GlaxoSmithKline (GSK) discontinued Flovent, a popular steroid inhaler that is used to lower the frequency of asthma attacks and other symptoms. The company discontinued production of the branded product in preparation for the rollout of an “authorized generic” version of the widely prescribed medication. The Asthma and Allergy Foundation of America estimates that about 25 million people have asthma in the United States and using inhaled corticosteroids like Flovent are among the most effective treatments for the disease. Here’s what you should know.

[Related: Gas stoves could be making thousands of children in America sick.]

What is Flovent?

Flovent is the brand name of fluticasone, a medication that has been sold since 2020. It is an inhaled corticosteroid that can be used by people four years of age and older for treating asthma long term. Fluticasone helps to keep inflammation in the lungs low and the airways open. It is used twice per day and is not a rescue inhaler. When it is taken every day, it can lower the number and severity of asthma attacks. 

GSK first notified the FDA about the decision to stop manufacturing Flovent in June 2023.

Why is there a new ‘authorized generic’ version?

According to a statement from GSK to the Allergy Foundation of America, the generic version of the prescription inhaler will have an identical formula and drug-delivery mechanism. GSK says that this new version will provide lower cost alternatives

However, this switch from the branded version to a generic one occurs at the same time as the elimination of the rebate cap removal of Medicaid drug prices. This provision was made as part of the American Rescue Plan Act of 2021. Under it, pharmaceutical companies are required to pay states higher Medicaid rebates if they raise the cost of the drug more than inflation. According to GoodRx, Flovent’s average price increased from about $207 in 2013 to $292 in 2018 and has gone up by 47 percent since 2014. 

“Flovent Diskus has been on the market since 2000 and Flovent HFA since 2004, and GSK has hiked the price on both products numerous times since their launch,” Dr. William Feldman, an associate physician in the Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital, told CNN. “These are precisely the sort of drugs that will be affected by the new policy eliminating the Medicaid rebate cap.”

Instead of being a typical generic medication that is made by a different company to compete with the original product, the “authorized generic” is made by the same company. GSK can continue to set prices

[Related: Common asthma medications may change brain matter, but don’t panic.]

Are doctors concerned?

In late 2023, both the American Academy of Pediatrics and the Asthma and Allergy Foundation of America expressed concern that discontinuing Flovent may leave those who rely on it with higher co-pays and delayed access, as patients have to clear coverage with their insurance company. 

“In general, people think generics should be cheaper,” Asthma and Allergy Foundation of America president and CEO Kenny Mendez told NPR. “That’s kind of the common knowledge, but it really depends on… your insurance plan and what’s covered and what’s not.”

Doctors are reporting that some insurers are not covering GSK’s new authorized generic version. Even if insurance authorizes coverage, patients may end up paying more than they would have if they were purchasing the previous branded version of the medication at a pharmacy. Some patients will also need to change asthma drugs or get new prescriptions for GSK’s authorized generic, which adds barriers that could disrupt critical asthma care

Due to its popularity over the past 24 years, some medical professionals fear it will create a “huge shock to the system” for doctors and those with asthma. Patients are advised to see their doctors as soon as possible to explore alternative medications and see if the new authorized generic version of Flovent is not covered by their insurance. 

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A ‘brain organoid’ biochip displayed serious voice recognition and math skills https://www.popsci.com/technology/brainoware-brain-organoid-chip/ Tue, 12 Dec 2023 19:35:00 +0000 https://www.popsci.com/?p=595217
Brainoware biocomputing study illustration
The Brainoware chip can accurately differentiate between human speakers using just a single vowel sound 78 percent of the time. Indiana University

Researchers dubbed it Brainoware.

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Brainoware biocomputing study illustration
The Brainoware chip can accurately differentiate between human speakers using just a single vowel sound 78 percent of the time. Indiana University

Your biological center for thought, comprehension, and learning bears some striking similarities to a data center housing rows upon rows of highly advanced processing units. But unlike those neural network data centers, the human brain runs an electrical energy budget. On average, the organ functions on roughly 12 watts of power, compared with a desktop computer’s 175 watts. For today’s advanced artificial intelligence systems, that wattage figure can easily increase into the millions.

[Related: Meet ‘anthrobots,’ tiny bio-machines built from human tracheal cells.]

Knowing this, researchers believe the development of cyborg “biocomputers” could eventually usher in a new era of high-powered intelligent systems for a comparative fraction of the energy costs. And they’re already making some huge strides towards engineering such a future.

As detailed in a new study published in Nature Electronics, a team at Indiana University has successfully grown their own nanoscale “brain organoid” in a Petri dish using human stem cells. After connecting the organoid to a silicon chip, the new biocomputer (dubbed “Brainoware”) was quickly trained to accurately recognize speech patterns, as well as perform certain complex math predictions.

As New Atlas explains, researchers treated their Brainoware as what’s known as an “adaptive living reservoir” capable of responding to electrical inputs in a “nonlinear fashion,” while also ensuring it possessed at least some memory. Simply put, the lab-grown brain cells within the silicon-organic chip function as an information transmitter capable of both receiving and transmitting electrical signals. While these feats in no way imply any kind of awareness or consciousness on Brainoware’s part, they do provide enough computational power for some interesting results.

To test out Brainoware’s capabilities, the team converted 240 audio clips of adult male Japanese speakers into electrical signals, and then sent them to the organoid chip. Within two days, the neural network system partially powered by Brainoware could accurately differentiate between the 8 speakers 78 percent of the time using just a single vowel sound.

[Related: What Pong-playing brain cells can teach us about better medicine and AI.]

Next, researchers experimented with their creation’s mathematical knowledge. After a relatively short training time, Brainoware could predict a Hénon map. While one of the most studied examples of dynamical systems exhibiting chaotic behavior, Hénon maps are a lot more complicated than simple arithmetic, to say the least.

In the end, Brainoware’s designers believe such human brain organoid chips can underpin neural network technology, and possibly do so faster, cheaper, and less energy intensive than existing options. There are still a number of hurdles—both logistical and ethical—to clear, but although general biocomputing systems may be years down the line, researchers think such advances are “likely to generate foundational insights into the mechanisms of learning, neural development and the cognitive implications of neurodegenerative diseases.”

But for now, let’s see how Brainoware can do in a game of Pong.

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Law enforcements can obtain prescription records from pharmacy giants without a warrant https://www.popsci.com/technology/pharmacy-prescription-privacy/ Tue, 12 Dec 2023 17:15:00 +0000 https://www.popsci.com/?p=595180
Pharmacy shelves stocked with medications
Unlike search warrants, subpoenas do not require a judge's approval to be issued. Deposit Photos

The pharmacy chains recently confirmed that law enforcement can just subpoena sensitive patient information.

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Pharmacy shelves stocked with medications
Unlike search warrants, subpoenas do not require a judge's approval to be issued. Deposit Photos

America’s eight largest pharmacy providers shared customers’ prescription records to law enforcement when faced with subpoena requests, The Washington Post reported Tuesday. The news arrives amid patients’ growing privacy concerns in the wake of the Supreme Court’s 2022 overturn of Roe v. Wade.

The new look into the legal workarounds was first detailed in a letter sent by Sen. Ron Wyden (D-OR) and Reps. Pramila Jayapal (D-WA) and Sara Jacobs (D-CA) on December 11 to the secretary of the Department of Health and Human Services.

[Related: Abortion bans are impeding medication access.]

Pharmacies can hand over detailed, potentially compromising information due to legal fine print. Health Insurance Portability and Accountability Act (HIPAA) regulations restrict patient data sharing between “covered entities” like doctor offices, hospitals, and other medical facilities—but these guidelines are looser for pharmacies. And while search warrants require a judge’s approval to serve, subpoenas do not.  

Representatives for companies including CVS, Rite Aid, Kroger, Walgreens, and Amazon Pharmacy all confirmed their policies during interviews with congressional investigators in the months following Dobbs v. Jackson Women’s Health Organization. Although some pharmacies require legal review of the requests, CVS, Rite Aid, and Kroger permit their staff to deliver any subpoenaed records to authorities on the spot. Per The WaPo, those three companies alone own 60,000 stores countrywide; CVS itself employees over 40,000 pharmacists.

According to the pharmacy companies, the industry giants annually receive tens of thousands of subpoenas, most often related to civil lawsuits. Information is currently unavailable regarding how many of these requests pharmacy locations were honored, as well as how many originated from law enforcement.

Given each company’s national network, patient records are often shared interstate between any pharmacy location. This could become legally fraught for medical history access within states that already have—or are working to enact—restrictive medical access laws. In an essay written for The Yale Law Journal last year, cited by WaPo, University of Connecticut associate law professor Carly Zubrzycki argued, “In the context of abortion—and other controversial forms of healthcare, like gender-affirming treatments—this means that cutting-edge legislative protections for medical records fall short.”

[Related: The dangers of digital health monitoring in a post-Roe world.]

Zubrzycki warns that, “at the absolute minimum,” patients seeking reproductive and gender-affirming healthcare “must be made aware of the risks posed by the emerging ecosystem of interoperable records.”

“To permit people to receive care under the illusion that their records cannot come back to harm them would be a grave injustice,” she wrote at the time.

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FDA approves the first gene-editing treatment in the US https://www.popsci.com/health/fda-crispr-sickle-cell-disease/ Fri, 08 Dec 2023 19:30:00 +0000 https://www.popsci.com/?p=594631
A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope at the Max-Delbrueck-Centre for Molecular Medicine.
A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope at the Max-Delbrueck-Centre for Molecular Medicine. Gregor Fischer/picture alliance via Getty Images

The CRISPR-based treatment targets sickle cell disease, but questions about cost remain.

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A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope at the Max-Delbrueck-Centre for Molecular Medicine.
A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope at the Max-Delbrueck-Centre for Molecular Medicine. Gregor Fischer/picture alliance via Getty Images

Today, the United States Food and Drug Administration (FDA) approved a historic treatment for sickle cell disease. Casgevy is the first medicine based on CRISPR gene-editing technology. The procedure was approved for use in the United Kingdom in November

[Related: The UK becomes the first country to approve CRISPR treatment.]

Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field especially for individuals whose lives have been severely disrupted by the disease by approving two cell-based gene therapies today,” Doctor Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited.”

The life-long genetic condition is caused by errors in the genes for the protein hemoglobin. Red blood cells use hemoglobin to carry oxygen through the body. The abnormal hemoglobin makes the blood cells crescent-shaped and hard. The misshapen cells then clump together and block the flow of oxygen to the organs, which causes extreme pain. The cells can then die off early, which leads to anemia.

Sickle cell disease is particularly common among people with Caribbean or African ancestry and affects more than 100,000 Americans. Previously, the only known cure for sickle cell disease was a bone marrow transplant from a donor. These procedures come with the risk of rejection by the patient’s immune system and finding a matching donor is a difficult process. 

How Casgevy works

Casgevy uses CRISPR-Cas9 gene editing technique, which allows scientists to make precise alterations to human DNA. French microbiologist, geneticist, and biochemist Emmanuelle Charpentier and American biochemist Jennifer A. Doudna shared the 2020 Nobel Prize in Chemistry for their work developing the technique.

The procedure uses stem cells taken from a patient’s bone marrow. The cells are then brought into a lab and the genes that are meant to switch on a functioning version of hemoglobin are edited with CRISPR. Patients must then go through a “conditioning treatment.” This can involve taking a drug that suppresses the immune system, radiotherapy, or chemotherapy to get the body ready for an infusion of CRISPR-modified cells back into the body. The new treatment does not come with the risk of graft versus host disease the way that a traditional bone marrow transplant does.

The approval comes on the heels of a clinical trial with 45 patients. Of these, 29 patients have been in the trial long enough for the researchers to gauge how effective Casgevy is. For at least 12 months after treatment, 28 were free of severe pain caused by the disease.

[Related: These organisms have a natural gene-editing system that could be more useful than CRISPR.]

How Lyfgenia works

The FDA also approved another sickle cell treatment called Lyfgenia. The gene therapy from Bluebird Bio. also modifies a patient’s stem cells. Both Lyfgenia and Casgevy require a conditioning treatment that removes cells and bone marrow so that they can be replaced with the modified cells.

According to the FDA,  patient’s blood stem cells are then genetically modified to produce HbAT87Q. This gene-therapy-derived hemoglobin functions similarly to hemoglobin A, or the normal adult hemoglobin produced by those who do not have sickle cell disease. Red blood cells that have HbAT87Q come with a lower risk of sickling and occluding blood flow. The modified stem cells are then delivered to the patient in a one-time, single-dose infusion. 

Lyfgenia’s safety and analysis is based on data from a 24-month study. Of the 32 patients in the study, 88 percent did not have a recurrent vaso-occlusive crises. These hallmarks of the disease occur when blood microcirculation is obstructed by sickled red blood cells, injuring organs and causing extreme pain.  It does have a risk of blood cancer and a black box warning is included in the label. The FDA also advises that patients should have continued monitoring for blood cnacer

Questions for the future

These groundbreaking therapies are expected to be incredibly expensive. A report from a fair prices nonprofit the Institute for Clinical and Economic Review, a nonprofit group that helps evaluate the value of medical tests and treatments found that the therapy could cost about $2 million per patient. It could be out of reach for many families and does not include additional care costs. 

“We really have to make sure that it is accessible,” Cleveland Clinic pediatric hematologist-oncologist Rabi told NBC News. “This could be an equalizer for people with sickle cell because many patients cannot pursue career options because of the illness.” Hanna previously served on the advisory board for Vertex, who makes Casgevy.

The treatments are also very time consuming. Between the pre-treatment conditioning, treatment itself, and follow up, patients have to spend weeks and possibly months in the hospital.

“I think there will be immediate uptake in some portion of the patients who have more severe disease—frequent pain episodes that cause hospitalization and require opioids for the treatment of pain,” said Boston Children’s Hospital hematologist and oncologist David Williams, told Stat. He added that there could be “bumps in the road” if pharmaceutical companies run into trouble manufacturing these complicated treatments or if the price tag keeps it out of reach for many patients. 

The long term effects are also still not known. The FDA says that patients who received Casgevy or Lyfgenia will be followed in a long-term study to evaluate safety and effectiveness.

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Swapping surgical bone saws for laser beams https://www.popsci.com/technology/bone-laser-surgery/ Wed, 06 Dec 2023 17:45:00 +0000 https://www.popsci.com/?p=594135
Researchers working with laser array in lab
The new device's collaborators working at the laser lab. Universität Basel, Reinhard Wendler

More lasers may allow for safer and more precise medical procedures.

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Researchers working with laser array in lab
The new device's collaborators working at the laser lab. Universität Basel, Reinhard Wendler

When it comes to slicing into bone, three lasers are better than one. At least, that’s the thinking behind a new, partially self-guided surgical system designed by a team at Switzerland’s University of Basel.

Although medical fields like ophthalmology have employed laser tools for decades, the technology’s applications still remain off the table for many surgical procedures. This is most frequently due to safety concerns, including the potential for lasers to injure surrounding tissues beyond the targeted area, as well as a surgeon’s lack of full control over incision depth. To potentially solve these issues, laser physicists and medical experts experimented with increasing the number of lasers used in a procedure, while also allowing the system to partly monitor itself. Their results are documented in a recent issue of Laser Surgeries in Medicine.

[Related: AI brain implant surgery helped a man regain feeling in his hand.]

It’s all about collaboration. The first laser scans a surgery site while emitting a pulsed beam to cut through tissue in miniscule increments at a time. As the tissues vaporize, a spectrometer  analyzes and classifies the results using on-board memory to map the patient’s bone and soft tissue regions. From there, a second laser takes over to cut bone, but only where specifically mapped by its predecessor. Meanwhile, a third optical laser measures incisions in real-time to ensure the exact depth of cuts.

Using pig legs acquired from a nearby supplier, researchers determined their laser trifecta accurately performed the surgical assignments down to fractions of a millimeter, and nearly as fast as the standard methods in use today. What’s more, it did it all sans steady human hands.

“The special thing about our system is that it controls itself without human interference,” laser physicist Ferda Canbaz said in a University of Basel’s profile on December 5.

The system’s benefits extend further than simply getting the job done. The lasers’ smaller, extremely localized incisions could allow tissue to heal faster and reduce scarring in the long run. The precise cutting abilities also allow for shaping certain geometries that existing tools cannot accomplish. From a purely logistical standpoint, less physical interaction between surgeons and patients could also reduce risks of infections or similar postsurgical complications.

Researchers hope such intricate angling could one day enable bone implants to physically interlock with a patient’s existing bone, potentially even without needing bone cement. There might even come a time when similar laser arrays could not only identify tumors, but subsequently remove them with extremely minimal surrounding tissue injury.

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It’s stuffy nose season. Here’s how to cope https://www.popsci.com/health/nasal-congestion-season/ Mon, 04 Dec 2023 14:00:00 +0000 https://www.popsci.com/?p=593578
A woman in pain puts her hands up to her nosed with her eyes closed.
Nasal congestion occurs when the mucus membranes that line the nose become swollen and more mucus is produced. Deposit Photos

The popular nasal decongestant phenylephrine was deemed ineffective in pill form in September.

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A woman in pain puts her hands up to her nosed with her eyes closed.
Nasal congestion occurs when the mucus membranes that line the nose become swollen and more mucus is produced. Deposit Photos

Alongside colder temperatures, stuffy nose season has officially arrived for many of us. This is also the first cold season since an independent advisory committee to the Food and Drug Administration declared that a common decongestant called phenylephrine is ineffective as when taken in pill form. In response, CVS pulled some of the products off of shelves completely. Here’s some guidance on what might actually work. 

[Related: What’s the difference between COVID, flu, and cold symptoms?]

How do decongestants work?

Nasal and sinus congestion is caused by viral infections from a cold or the flu or allergies. The mucus membranes that line the nose become swollen and more mucus is produced in response. Oral decongestants taken in pill form and topical decongestants in spray form can provide relief. 

“They stimulate the autonomic nervous system to give you a response similar to adrenaline or epinephrine, which constricts blood vessels,” Boston University physician and head and neck surgeon Michael Platt told The Brink. “So, in your nose, you’re shrinking the blood vessels and decreasing the blood supply into the nose. Structures in the nose, called turbinates, swell up when you get a cold or allergies. They’re like round balls of tissue in your nose, and they fill up with blood and get swollen, and when you take a decongestant, it shrinks those blood vessels. It also makes your blood pressure go up, just like adrenaline does.”

Look for pseudoephedrine

This FDA-approved oral decongestant is very effective at clearing congestion caused by common colds and seasonal allergies. It helps narrow the blood vessels in the nasal passages. Some brand name medications that contain pseudoephedrine include regular Sudafed, Dimetapp, and Biofed

While they don’t require a prescription, they require customers to show their driver’s license or another government-issued photo ID and there are limits to how many you can buy. The drug was moved behind the counter in 2006 after reports that it can be used to make the illegal drug methamphetamine in large quantities.

Vanderbilt University Medical Center ear, nose, and throat doctor Marc Feeley told AARP that while these are effective, medicines with pseudoephedrine may not be the best choice for those with cardiovascular issues, since it can raise blood pressure. Those with heart disease or hypertension should speak with their doctors before taking anything with pseudoephedrine.

[Related: Cold temperatures could make our respiratory systems more vulnerable to infection.]

Try a nasal spray

While the recently demoted phenylephrine is ineffective in pill form, it does work as a nasal spray. Sprays containing both phenylephrine and a nasal decongestant called oxymetazoline are good options for relieving congestion. Some brand name options with phenylephrine include Vicks Sinex and Nostril. Nasal sprays with oxymetazoline include Afrin, Mucinex Full Force, and Vicks Sinex 12 Hour.

Johns Hopkins Sinus Center director and rhinologist Andrew Lane told Scientific American that oxymetazoline is the stronger and quicker of the two, but that both sprays should only be used for three days. 

“These medications act on adrenergic receptors on the blood vessels that line the nose’s mucous membranes. If you take the spray around the clock for many days in a row, those receptors get overstimulated and become resistant to the medication,” said Lane. “The effects last less and less, and people keep using it more and more frequently, until they feel like they can’t breathe without it. We call that rhinitis medicamentosa, or rebound congestion.”

Steroid nasal sprays 

If your nose is less congested and more runny and also comes with itchy eyes, allergies may be causing the symptoms. H. James Wedner, a professor of medicine in the Division of Allergy and Immunology at Washington University School of Medicine, told AARP that corticosteroid nasal sprays are best in this situation.

These sprays include brand names like Flonase, Nasacort, and Rhinocort. According to Wedner, they must be taken for a few days or weeks for maximum benefits.

Hydration, steam, and more

Some other options that may work include using a humidifier, taking a warm shower, applying warm compresses to the nose, and flushing out the sinuses using a neti pot. It is also important to stay hydrated and drink plenty of fluids if you have cold and flu symptoms. 

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Can our eyes ever fix themselves? https://www.popsci.com/health/can-our-eyes-ever-fix-themselves/ Fri, 17 Nov 2023 15:00:00 +0000 https://www.popsci.com/?p=585254
colorful dna strands; illustration
Aaron Fernandez for Popular Science

Behind the daring therapies that target the genetic roots of ocular disease.

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colorful dna strands; illustration
Aaron Fernandez for Popular Science

OUR EYES, unlike other organs hidden deep within our bodies, sit in plain sight. They have been inspirations for artists, symbols for the superstitious, and objects of scientific fascination for centuries. In ancient Greece, medical pioneers cut them open in public dissections, revealing delicate layers of retina, cornea, and iris. In the early 10th century, Persian physician al-Razi discovered that the pupil dilates and contracts to control the amount of light that enters. Six centuries later, the Renaissance-era anatomist Vesalius sketched a cross-section of the orb—with some errors. But eyes themselves are imperfect: Just one fault could cause the whole organ to glitch or break down. 

It turns out that flaws are common in our vision. More than 7 million Americans have some form of vision loss, which can include partial or full blindness, according to a 2021 analysis of 25 years of data from the US Census, the Centers for Disease Control and Prevention, and others. Many of these conditions are present from birth. Mutations in particular regions of DNA can lead to incorrectly formed optical parts. This can distort a person’s sight, especially if the issues are in the retina, the layer of cells at the back of the eye that captures incoming light and transmits it to the brain. But what if we could give someone with limited vision a corrected version of their genetic material to fix the malfunctioning parts?

Currently, there is no way to fully reverse inherited forms of blindness, which are traditionally managed with adaptations rather than treatments. “I speak to a lot of parents who are really frustrated about the lack of standard of care,” says Shannon Boye, a professor in the pediatrics department at the University of Florida. “They’re desperate for cures.”

But understanding the genetic roots of the disability helps. In theory, if scientists can pinpoint the problematic or missing DNA that’s hampering a person’s vision, they can design a rectified copy. The new genetic code is loaded into harmless viruses that deliver therapeutic genes to selected cells, and the viruses are then injected into the affected eye. There, the replacement DNA instructs the eye to make the proteins it needs to see again. 

In practice, it’s not so easy. The Food and Drug Administration (FDA) has approved only one gene therapy to treat a form of blindness—the first gene therapy the agency ever greenlit. Called Luxturna, it was OK’d in the US in 2017 to treat patients with mutations that lead to Leber congenital amaurosis (LCA). In people with this uncommon flaw, light-detecting photoreceptor cells in the retina develop incorrectly, become malformed, or die, leading to rapid vision loss early in life. Luxturna provides the correct version of the gene, partially restoring vision.

“This was a godsend scenario,” says Claudio Punzo, an expert in vision genetics at the University of Massachusetts Chan Medical School. There are several types of LCA, but the retina degrades more slowly in the form of the disease that Luxturna treats, which creates a larger window for the gene therapy to work. What’s more, people with the condition are often completely blind, so even a small improvement in their sight is life changing.

After that first FDA approval, “Unfortunately, the field hit a lull,” Boye says. But she is confident that with new genetic tools, Luxturna’s success story can be replicated on a much larger scale. 

One big step has been designing better couriers for the corrected code. Many gene therapies use naturally harmless adeno-associated viruses, which researchers modify to home in on retinal photoreceptors or other key cell types. Boye imagines a modular system using a suite of viral vessels designed for different destinations, in which any gene can be loaded as cargo. 

“Will we get it to work for everyone? With every mutation? Most likely, yes, at some point,” says Punzo. “It just becomes a logistical problem.” There are hundreds of different mutations that can cause blindness, and finding the right gene to fix in the right cell is no small task. For genes that are too large to fit inside a virus, CRISPR editing technology might offer an alternative method to correct the mutation directly in the patient’s DNA. In 2022, biotech company Editas tried using CRISPR to treat a form of LCA by removing a mutation in the retinal gene CEP290, but it paused the trial when vision in only three out of the 14 participants improved.

For people with visual disabilities, the invasiveness of current treatments is another major hurdle. These methods typically require surgeries to deliver the gene close to the retina, a process that itself can cause mild retinal damage. For someone with a less severe disease, such as night blindness or color blindness, the risks may not be worth the modest benefit. Shots in parts of the eye farther from the retina would be less invasive, but they are not yet standard for gene therapy. Another appealing option would be eyedrops, which were recently used for the first time in an experimental treatment at the University of Miami on a 14-year-old boy with corneal scarring. After months of the topical treatment, his sight returned to near-normal levels.

Cost is another obstacle. When Luxturna first hit the market in 2018, its price tag was $425,000 per eye. In part, the expense comes from the meticulous process of making a virus that won’t harm a patient. But the other part of the equation is the biotech industry’s irresistible pitch: We can help you see again. For people who are progressively losing their vision, even slowing down the process could be priceless—or so gene therapy companies hope. 

Most major insurers cover one dose of Luxturna per eye for patients whose retinas are intact enough to heal. But the hopefuls may still be on the hook for out-of-pocket costs associated with the procedure, or the cost of travel to one of 14 certified treatment centers in the US. “[It’s] an insanely expensive treatment,” Punzo says. “If there are cheaper drugs that would work, I think it will change the market.”

Currently, dozens of gene therapy clinical trials for hereditary forms of blindness are in progress, and many more are in the planning stages. They span diverse conditions, including Stargardt disease (which causes fat to build up in the eye), achromatopsia (a form of color blindness), and retinitis pigmentosa (which makes the retina break down). But progress is slow: Many have been at it for more than a decade with years to go.

Boye knows this firsthand. She co-founded a company called Atsena Therapeutics that is currently conducting a clinical trial for a virus-delivered code to correct an LCA-causing mutation. Her confidence that gene therapies can reverse blindness stems from both data and patients’ stories. She recalls a young girl who got the corrective treatment: As her vision improved, the child was able for the first time to see snowflakes—delicate, magical, and unlike anything she had experienced in her life.

Read more PopSci+ stories.

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The UK becomes the first country to approve CRISPR treatment https://www.popsci.com/health/the-uk-becomes-the-first-country-to-approve-crispr-treatment/ Thu, 16 Nov 2023 20:00:00 +0000 https://www.popsci.com/?p=590085
A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope at the Max-Delbrueck-Centre for Molecular Medicine.
A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope. Gregor Fischer/Picture Alliance/Getty Images

The new therapy uses gene editing to treat sickle cell disease and beta thalassemia.

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A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope at the Max-Delbrueck-Centre for Molecular Medicine.
A researcher handles a petri dish while observing a CRISPR/Cas9 process through a stereomicroscope. Gregor Fischer/Picture Alliance/Getty Images

Today, the United Kingdom became the first country to give regulatory approval to a medical procedure that uses CRISPR gene editing. The Medicines and Healthcare products Regulatory Agency (MHRA) approved Casgevy, a therapy that will be used to treat sickle cell disease and beta thalassemia (also called β -thalassaemia). 

[Related: CRISPR breaks ground as a one-shot treatment for a rare disease.]

What are sickle cell disease and beta thalassemia? 

Both diseases are painful, life-long genetic conditions that are caused by errors in the genes for a protein called hemoglobin. Red blood cells use hemoglobin to carry oxygen around the body. Sickle cell disease is particularly common among people with Caribbean or African ancestry. The abnormal hemoglobin makes the blood cells crescent-shaped and hard. The misshapen cells then clump together and block the flow of oxygen to the organs, which causes extreme pain. The cells can then die off early, which leads to anemia. 

Beta thalassemia primarily affects patients with Mediterranean, south Asian, southeast Asian, and Middle Eastern backgrounds. It also causes anemia since the mody cannot make as much hemoglobin.  

Casgevy was developed by Boston’s Vertex Pharmaceuticals and Switzerland’s Crispr Therapeutics and could be used to replace bone marrow transplants. The companies estimate that roughly 2,000 people in the UK are now eligible for the therapy.

“I am pleased to announce that we have authorized an innovative and first-of-its-kind gene-editing treatment called Casgevy, which in trials has been found to restore healthy hemoglobin production in the majority of participants with sickle-cell disease and transfusion-dependent beta thalassaemia, relieving the symptoms of disease,” interim executive director of healthcare quality and access at the MHRA Julian Beach said in a statement

How does Casgey use CRISPR gene editing?

The new treatment uses the CRISPR-Cas9 gene editing technique, which enables scientists to make precise alterations to human DNA. French microbiologist, geneticist and biochemist Emmanuelle Charpentier and American biochemist Jennifer A. Doudna, who shared the 2020 Nobel Prize in Chemistry for their work. 

Casgevy uses stem cells taken from a patient’s bone marrow. The cells are then brought into a lab and the genes that are meant to switch on a functioning version of hemoglobin are edited with CRISPR. According to the MHRA, patients must then go through a “conditioning treatment.” This can involve taking a drug that suppresses the immune system, radiotherapy, or chemotherapy to get the body ready for an infusion of CRISPR-modified cells back into the body. The new treatment does not come with the risk of graft versus host disease the way that a traditional bone marrow transplant does.

[Related: These organisms have a natural gene-editing system that could be more useful than CRISPR.]

After the infusion, patients may need to remain in a hospital facility for at least a month. During this time, the treated cells will begin to “take up residence” in the bone marrow and make red blood cells that have a stable form of hemoglobin.

While seeking regulatory approval, the researchers performed a clinical trial of 45 patients with sickle-cell disease. Of this group, 29 patients have been in the trial long enough for the researchers to gauge how effective Casgevy is. Of these eligible patients, 28 were free of severe pain crises for at least 12 months after treatment.  

In the clinical trial of 54 patients with transfusion-dependent beta thalassemia, 42 patients have been in the trial long enough to determine efficacy. Of these, 39 did not require a red blood cell transfusion for at least 12 months after the treatment. The remaining three had more than a 70 percent reduction in the need for red cell transfusions. 

“This is a great step in the advancement of medical approaches to tackle genetic diseases we never thought would be possible to cure,” University of Hertfordshire geneticist Alena Pance said a statement released by the Science Media Centre. “Modifying the stem cells from the bone marrow of the patient avoids the problems associated with immune compatibility, i.e. searching for donors that match the patient and following immunosuppression, and constituting a real cure of the disease rather than a treatment.”

The United States Food and Drug Administration is evaluating this same treatment. On October 31, an advisory committee to the FDA said that treatment was safe for patients. It is expected to make a decision by December 8. 

A price for the therapy has not been announced, but it will likely be expensive

Previously

Despite its potential for good, CRISPR has been tainted with controversy and ripe for debate over the fear of being able to pick and choose genes for so-called “designer babies.” In 2018, Chinese scientist He Jiankui announced that he had created the first gene-edited babies in the world. He was found guilty of conducting “illegal medical practices” and sentenced to 3 years in prison. This work furthered the debate of how to best regulate this powerful technique, with many saying that it shouldn’t be used to edit human genes that will be passed down to the next generation. 

Other experiments and trials with using the gene editing technique on rare diseases have continued. In 2021, a clinical trial for a drug called NTLA-2001 began, researchers attempted to treat six people with a rare genetic disease called transthyretin amyloidosis with a technology that delivers CRISPR directly to cells in the liver. The FDA cleared the trial to enter its critical third phase in October.

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This tiny wireless wearable continuously monitors your body’s internal soundtrack https://www.popsci.com/technology/wearable-respiratory-monitor/ Thu, 16 Nov 2023 17:00:00 +0000 https://www.popsci.com/?p=589980
Close up of doctor's hand attaching wearable soft stethoscope patch to patient's chest
Researchers hope the new invention will save the lives of both elderly patients, as well as premature infants. Northwestern University

A new soft device offers doctors a small, flexible symphony of stethoscopic information.

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Close up of doctor's hand attaching wearable soft stethoscope patch to patient's chest
Researchers hope the new invention will save the lives of both elderly patients, as well as premature infants. Northwestern University

The common stethoscope’s recognizable design has remained largely unchanged for decades for good reason—there’s really not much to improve at this point. When it comes to listening in on a patient’s internal soundtrack, the standard, adjustable bell connected via short rubber tubing to binaural earpieces is perfectly suited for helping assess respiratory and cardiac health.

Of course, a stethoscope can only relay vitals in person based on its specific placements; long term monitoring often requires extended clinical stays alongside bulky, wired devices. To solve these problems, a team of medical experts, researchers, and engineers at Northwestern University set out to design a new wearable capable of providing highly detailed, continuous, real-time information regardless of a patient’s environment. After painlessly adhering to specific areas of the chest, the resulting soft devices not only accomplish these goals, but already show immense promise for both adults, as well as premature babies often dealing with gastrointestinal complications and apneas.

[Related: Pill cuts lung cancer deaths in half, study says.]

“Currently, there are no existing methods for continuously monitoring and spatially mapping body sounds at home or in hospital settings,” John Rogers, a bioelectronics expert who oversaw the new tool’s design and development, said in a recent Northwestern University profile.

As detailed in a new study published in Nature Medicine, Rogers and fellow researchers placed a miniature battery, electronics, Bluetooth relay, flash memory drive, and two microphones within a 40mm long, 20mm wide, and 8 mm thick soft silicone casing—roughly the size of a stick of gum. Each microphone is positioned in opposing directions, into and outside the patient, to filter exterior ambient noises from a wearer’s bodily sounds. The team notes this is particularly helpful in situations such as lung monitoring, since the organ is simply too quiet when compared to noisy hospital surroundings.

Ankit Bharat, a thoracic surgeon who oversaw adult subject clinical device trials, describes it pretty succinctly in Northwestern’s November 16 announcement:

“Simply put, it’s like up to 13 highly trained doctors listening to different regions of the lungs simultaneously with their stethoscopes, and their minds are synced to create a continuous and a dynamic assessment of the lung health that is translated into a movie on a real-life computer screen.”

[Related: Almost everyone in the world breathes unhealthy air.]

Aside from adult lung and gastrointestinal health monitoring, the tiny wearables show incredible promise for infants—particularly those born with potential medical issues. Babies’ respiratory systems only fully mature during the third trimester of pregnancy, meaning many apnea and breathing disorders often accompany premature deliveries. Given these infants’ physical size, traditional stethoscopes are both impractical and too large to provide accurate, prolonged monitoring. And even for healthy delivered children, breathing and gastrointestinal issues are major concerns during their first five years. The team’s new wearables, however, account for these issues by providing a new, size-appropriate tool.

Every human body is host to a wide array of acoustic and tonal signatures. Once the particular sounds are documented, the team hopes their wearable will make it much easier to pick out irregularities stemming from serious, overlooked health issues. If detected early enough, such discoveries could potentially save countless lives.

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Lab-made ‘super melanin’ speeds up healing and boosts sun protection https://www.popsci.com/health/super-melanin/ Thu, 02 Nov 2023 19:00:00 +0000 https://www.popsci.com/?p=585647
The synthetic melanin is being applied to Inflamed skin. Just under the surface of the skin are green free radicals, also known as ROS, or "reactive oxygen species."
The synthetic melanin is being applied to Inflamed skin. Just under the surface of the skin are green free radicals, also known as ROS, or "reactive oxygen species.". Yu Chen, Northwestern University

The synthetic pigment could be used in everything from military uniforms to cancer treatments.

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The synthetic melanin is being applied to Inflamed skin. Just under the surface of the skin are green free radicals, also known as ROS, or "reactive oxygen species."
The synthetic melanin is being applied to Inflamed skin. Just under the surface of the skin are green free radicals, also known as ROS, or "reactive oxygen species.". Yu Chen, Northwestern University

A team of scientists at Northwestern University have developed synthetic melanin that can accelerate healing in human skin. It is applied in a cream and can protect the skin from the sun and heal chemical burns, according to the team. The findings are described in a study published November 2 in the journal Nature npj Regenerative Medicine.

Medicine photo

What is melanin?

Melanin is a pigment that is naturally produced in humans and animals. It provides pigmentation to the hair, eyes, and skin. It protects skin cells from sun damage by increasing pigmentation in response to the sun–a process commonly called tanning

“People don’t think of their everyday life as an injury to their skin,” study co-author and dermatologist Kurt Lu said in a statement. “If you walk barefaced every day in the sun, you suffer a low-grade, constant bombardment of ultraviolet light. This is worsened during peak mid-day hours and the summer season. We know sun-exposed skin ages versus skin protected by clothing, which doesn’t show age nearly as much.”

[Related: A new artificial skin could be more sensitive than the real thing.]

Aging in the skin is also due to simply getting older and external factors like environmental pollution. Sun damage, chronological aging, and environmental pollutants can create unstable oxygen molecules called free radicals. These molecules can then cause inflammation and break down the collagen in the skin. It is one of the reasons that older skin looks very different than younger skin. 

‘An efficient sponge’

In the study, the team used a synthetic melanin that was engineered with nanoparticles. They modified the melanin structure so that it has a higher free radical-scavenging capacity.

Researchers used a chemical to create a blistering reaction to a sample of human skin tissue in a dish. The blistering looked like a separation of the upper layers of the skin from each other and was similar to an inflamed reaction to poison ivy. 

They waited a few hours, then applied their topical melanin cream to the injured skin. The cream facilitated an immune response within the first few days, by initially helping the skin’s own free radical-scavenging enzymes recover. A cascade of responses followed where healing sped up, including the preservation of the healthy layers of skin underneath the top layers. The synthetic melanin cream soaked up the free radicals and quieted the immune system. By comparison, blistering persisted in the control samples that did not have the melanin cream treatment. 

“The synthetic melanin is capable of scavenging more radicals per gram compared to human melanin,” study co-author and chemist/biomedical engineer Nathan Gianneschi said in a statement.  “It’s like super melanin. It’s biocompatible, degradable,nontoxic and clear when rubbed onto the skin. In our studies, it acts as an efficient sponge, removing damaging factors and protecting the skin.”

According to the team, the super melanin sits on the surface of the skin once it is applied and isn’t absorbed into the layers below. It sets the skin on a cycle of healing and repair that is directed by the body’s immune system. 

[Related: The lowest-effort skincare routine that will still make your skin glow.]

Protection from nerve gas

Gianneschi and Lu are studying using melanin as a protective dye in clothing. The thought is the pigment could act as an absorbent for toxins, particularly nerve gas. 

“Although it [melanin] can act this way naturally, we have engineered it to optimize absorption of these toxic molecules with our synthetic version,” Gianneschi said in a statement

They are also pursuing more clinical trials for testing their synthetic melanin cream. In a first step, they recently completed a trial showing that the synthetic melanins do not irritate human skin. Since it protects tissue from high energy radiation, it could also be an effective treatment for burns cancer patients undergoing radiation therapy often experience

This research was funded by the United States Department of Defense and the National Institutes of Health.

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Poop transplants might protect vulnerable patients from superbug infections https://www.popsci.com/health/fecal-transplant-antibiotic-resistance/ Wed, 01 Nov 2023 22:00:00 +0000 https://www.popsci.com/?p=585357
A microscopic image of small drug-resistant germs in yellow surrounding a larger human cell, in red.
Methicillin-resistant Staphylococcus aureus bacteria (yellow) and a human white blood cell (red). National Institute of Allergy and Infectious Diseases/NIH

A small clinical trial suggests a dose of fecal material could help flush out harmful bacteria.

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A microscopic image of small drug-resistant germs in yellow surrounding a larger human cell, in red.
Methicillin-resistant Staphylococcus aureus bacteria (yellow) and a human white blood cell (red). National Institute of Allergy and Infectious Diseases/NIH

Thousands of years ago, ancient Egyptians used moldy bread to heal infected cuts and wounds. They may not have realized it, but their bizarre medical practice relied on fungi to create chemicals that kill infection-causing bacteria. This, in other words, was a very rough draft of an antibiotic drug. These types of molds helped Alexander Fleming discover penicillin centuries later. And now, to fight off superbugs, scientists are increasingly turning to another unorthodox source of germ-killers: healthy poop.

Specifically, fecal microbiota transplants are safe and effective in stopping the growth of antibiotic-resistant bacteria, according to a small study published today in Science Translational Medicine. If additional clinical trials prove to be successful, poop transplants could be a promising method in populations at risk of resistant infections, such as patients who get organ transplants. 

Antibiotics have saved millions from deadly infections, and human life expectancy jumped dramatically after their discovery. But their overuse has caused some bacterial strains to develop methods of protection against the medications. Antibiotic-resistant strains are a global problem that was responsible for 5 million deaths in 2019. On top of that is the concerning rise of superbugs, strains of bacteria with the highest resistance to multiple drugs. 

[Related: FDA approves first fecal transplant pill]

Once a patient is infected with antibiotic-resistant bacteria, “there’s not really a way to get rid of colonization,” says Michael Woodworth, an assistant professor of medicine at Emory University School of Medicine and lead author of the new study. “Right now, there are no FDA approved therapies.” In the past, clinicians tried to get rid of superbugs with additional antibiotics, which can set up a “vicious cycle” in which medication promotes the growth of even stronger antibiotic-resistant bacteria.

The idea to use poop transplants to defeat superbugs came after a growing body of evidence shows they can help treat tough C. difficile infections, a germ that patients can get in a hospital. In people who had received poop transplants, it looked as though they had fewer chances of catching the antibiotic-resistant bacteria. 

The new research was a Phase 1 clinical trial that enrolled 11 people awaiting kidney transplants. Organ recipients typically receive preventative antibiotics after their transplants, but this has not stopped an increasing amount of antibiotic-resistant UTI infections in this population.

In the study, people were randomly selected to receive a poop transplant immediately after getting a kidney, or a poop transplant later on if their stool samples showed positive signs of antibiotic-resistant bacteria after day 36. If people continued to be positive for the microbes, they had a second poop transplant. The authors used an enema to administer all the poop transplants, a route the study notes would have the lowest rate of side effects. To reduce the risk of passing harmful bacteria through the fecal transplants, screening tests checked for pathogens known to be resistant. 

The research team detected significant results in the two groups, despite the small number of participants (COVID disrupted patient enrollment in the study). All treatments were safe for people who received one or two poop transplants. Additionally, eight out of nine people were negative for antibiotic-resistant bacteria after 36 days.

Genetic analysis of the stool samples showed that the poop transplants helped reduce the number of superbugs. This decolonization of bacteria, while it was not directly tested, may help in preventing recurrent antibiotic-resistant infections. 

[Related: Finding the world’s super poopers could save a lot of butts]

“This provides the ground to start a large, randomized, controlled study to assess the effect of [fecal microbiota transplants] on decolonizing multi-drug-resistant organisms,” says Seifeldin Hakim, a gastroenterologist with Memorial Hermann in Houston who was not involved in the study. Theoretically, it would make sense that lowering the number of antibiotic-resistant bacteria in the gut would decrease the chances of clinical infection or sepsis, Hakim says, but more evidence-based results are needed to support this.

Woodworth says poop transplants provide a mix of “good” bacteria to improve colonic health and strengthen the gut barrier. It’s also possible that another biological mechanism is at work. Woodworth hypothesizes that the poop transplants might have driven competition between antibiotic-resistant bacteria and non-resistant germs of the same species. This may have contributed to bacterial strains becoming more susceptible to antibiotics.

Because the trial was an early phase test, there are many more questions to answer, Woodworth says, such as figuring out the proper dose. His team is currently conducting two other clinical trials to research wider applications for fighting drug-resistant pathogens. They are currently planning a larger follow-up study, too, among people who received kidney transplants to better understand how competition between strains might reduce bacteria colonization.

There are still some kinks to work out with using fecal transplants, says Woodworth. However, he hopes this study can act as a jumping off point for inspiring other microbiome-related treatments to fight off antibiotic-resistant bacteria. To guide the next generation of therapies, poop may be our society’s moldy bread.

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CVS to stop selling cold and allergy pills that FDA warns don’t work https://www.popsci.com/health/phenylephrine-cvs-ineffective/ Fri, 20 Oct 2023 17:00:00 +0000 https://www.popsci.com/?p=581639
A box of a nasal decongestant called SudafedPe on a store shelf.
Some of the cold and allergy medications that CVS will no longer sell include Benadryl Allergy Plus Congestion, Vicks Sinex, and Sudafed PE. Tim Boyle/Getty Images

An FDA advisory committee declared that an active ingredient called phenylephrine is ineffective in pill form in September 2023.

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A box of a nasal decongestant called SudafedPe on a store shelf.
Some of the cold and allergy medications that CVS will no longer sell include Benadryl Allergy Plus Congestion, Vicks Sinex, and Sudafed PE. Tim Boyle/Getty Images

As cold and flu season approaches, pharmacy chain CVS announced that they are removing some over-the-counter allergy and cold medicines from their shelves since their active ingredient has been deemed ineffective as a decongestant when taken orally. The removed medications include Vicks Dayquill, Benadryl Allergy Plus Congestion, Sudafed PE, Vicks Sinex, and others that contain a decongestant called phenylephrine.

[Related: Why adult cold medicine is not good for children.]

A CVS spokesperson told CNBC that other oral cold medications that do not contain phenylephrine as the only active ingredient will remain on CVS’ shelves. Medications that contain phenylephrine account for about  $1.8 billion in annual sales, according to the Food and Drug Administration.

In September, an independent advisory committee to the FDA declared that phenylephrine is ineffective as a decongestant when taken in pill form. The panel refused to certify the effectiveness of these medications, adding that further trials to prove otherwise were required. 

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, told CBS News last month

In 2006, phenylephrine began to be substituted for an ingredient called pseudoephedrine in many non-prescription cold and allergy medicines. Pseudoephedrine was restricted amid reports of it being used to make the illegal drug methamphetamine. Phenylephrine cannot be used to make meth and was considered a suitable replacement. These medications with pseudoephedrine are still considered safe and can be bought without a prescription, but are now behind the pharmacy counter and require a photo ID

Allergies and respiratory infections alert the body to send white blood cells to the sinuses, nose, and throat, which causes the creation of mucus and swelling in the nasal membranes. Phenylephrine temporarily reduces the swelling in the blood vessels in the nasal passages when it is administered in the nose. Some experts say that when taken in a pill form, phenylephrine gets absorbed by the gut and metabolized so well that only a small amount of the decongestant will make it to the bloodstream. 

According to a 2015 citizen petition asking the FDA to remove drugs with phenylephrine, the amount that gets into the bloodstream is not enough to actually reach the nose and work to clear congestion. Citizen petitions like this one are a way for consumer groups, industry groups, or individuals to call on the FDA to change regulations or take other administrative action. The American Academy of Allergy, Asthma & Immunology supported this citizen petition.

[Related: Why we still don’t have a vaccine for the common cold.]

Consumers should consult a medical professional to best determine what decongestant to take, but can look for those that contain pseudoephedrine or antihistamines like Claratin or Zyrtec. Nasal sprays that contain phenylephrine are also still considered effective, in addition to those that contain another ingredient called oxymetazoline.

In September, director of endoscopic skull base surgery and a professor of otolaryngology at Stanford Medicine Zara Patel, told CNN that seeing a medication removed from store shelves like this should not be a reason to distrust regulatory agencies.

“This is how science works. As we gain more information, recommendations may change, and that’s not a bad thing. That’s the wonderful thing about science. We can use new information and change our perspective,” said Patel. She is not affiliated with the FDA committee.

Other national pharmacy chains including Walgreens and Rite Aid have not yet announced if they are pulling these medications as well.

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The US won’t regulate this deadly, addictive antidepressant https://www.popsci.com/health/what-is-tianeptine/ Fri, 20 Oct 2023 14:30:00 +0000 https://www.popsci.com/?p=581307
Red and white tianeptine antidepressant pills, which are unregulated by the FDA, on a hand on a red background
Tianeptine is sold in the US under many brand names, but typically the pills are red and white or just red. DepositPhotos

Multiple states have banned tianeptine, but not the FDA. Here’s why the drug can be dangerous.

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Red and white tianeptine antidepressant pills, which are unregulated by the FDA, on a hand on a red background
Tianeptine is sold in the US under many brand names, but typically the pills are red and white or just red. DepositPhotos

Tianeptine, also known as “gas station heroin,” is officially off the market—at least in Florida. The Sunshine State recently joined eight other US states (Alabama, Georgia, Indiana, Kentucky, Michigan, Mississippi, Ohio, and Tennessee) in forbidding sales of the over the counter pill, citing concerns for its high potential of abuse and addictive properties.

Florida’s attorney general issued an emergency ban in September after an increasing number of calls to the state’s Poison Control Center in the first half of 2023. A similar trend has been seen nationwide with 151 tianeptine poisoning cases in 2020. There are also reports of at least five fatal overdoses since the drug started being sold in the US. 

Tianeptine is still available at gas stations and convenience stores in 41 other states and is purchasable online. It’s up to individuals to know the dangers and avoid purchasing any related products. Here’s what you need to know.

What is tianeptine?

Tianeptine is a non-prescription antidepressant that has become a popular method of getting high in the US in the past decade. It’s even been found in powder form in counterfeit pills of hydrocodone and oxycodone. Some products market dietary supplements containing tianeptine under the brand names Tianaa, Tianna Green, Tianna Red, Tianna White, and ZaZa. Kelly Johnson-Arbor, a medical toxicologist based in Washington D.C., says some vendors claim tianeptine can improve brain function, treat opioid addiction, and help with anxiety, “but there is minimal literature supporting the use of tianeptine for these conditions.” While it may have potential to help with irritable bowel syndrome and chronic pain in medical settings, the threat of addiction appear to outweigh the benefits.

The antidepressant works by increasing the effects of serotonin, which is nicknamed the “happy hormone” because of its role in mood and emotions. Low serotonin levels are linked to depressive symptoms; while tianptine’s exact mechanism is still debated, other antidepressants like selective serotonin reuptake inhibitors (SSRIs) prevent the hormone from being absorbed by cells to prolong related brain activity. 

Tianeptine is not approved for any kind of medical use by the US Food and Drug Administration (FDA). Because it’s unregulated and sold in dietary supplements, little is known on the purity, efficacy, or safety of each product. What’s more, the amount of active drug can vary by brand or even by pill.

“Its unregulated status in the US also increases the potential for abuse or misuse, as there are no standard dosing recommendations [here] for this drug,” says Johnson-Arbor.

At higher doses, tianeptine starts affecting dopamine levels in addition to serotonin. This important hormone can contribute to addictive behavior by changing neural connectivity to reinforce an activity that brings feelings of pleasure and euphoria. The drug increases opioid activity in the brain, a similar mechanism of action seen in heroin.  

What are the dangers of using tianeptine?

Consumers are usually taking a gamble when they buy tianeptine products because they can’t know for sure how much of the drug they’re getting. This increases the risk of an unintentional overdose, along with other adverse side effects like lethargy, elevated blood pressure and heart rate, agitation, abdominal pain, tremors, and hallucinations.

Johnson-Arbor further warns that people may experience more unwanted side effects, including breathing difficulties, hallucinations, and excessive sleepiness, when combining tianeptine with other medications. Because of its high potential for drug abuse, those who regularly misuse the pills may exhibit withdrawal symptoms such as stomachaches and anxiety if they try to quit.

If you or someone you know develops unexpected symptoms after using tianeptine, contact Poison Control online at www.poison.org or by phone at 1-800-222-1222 for expert advice. Both options are free, confidential, and available 24 hours a day. If you’re trying to quit, help is available. Call the SAMHSA National Helpline at 1-800-662-4357 for substance use information and referrals for treatment.

Why isn’t tianeptine banned everywhere in the US?

Tianeptine is marketed as a prescription antidepressant in the European Union and some other countries. A few, including Turkey, have categorized tianeptine as a controlled substance. Johnson-Arbor says it’s reasonable to consider a similar classification of this drug in the US, but currently, there are no such plans.

The FDA issued a consumer warning about using tianeptine products in 2022 and has sent warning letters to two marketers, but hasn’t taken further action in the wake of more recent overdoses. In an email to PopSci, an agency representative wrote that “a drug sponsor would need to submit an application to the agency for review” for it to be approved for medical use, either as a controlled or uncontrolled substance. “The FDA generally cannot confirm or deny the existence of any possible product application,” he added. 

In the absence of federal regulations, state governments have stepped in to either allow or ban sales of the drug. This isn’t anything new: States have made similar decisions for popular dietary supplements like CBD products. And while there’s always a chance that pills can be poisonous when taken in the wrong amounts, with tianeptine, concerns are particularly high.

Correction (October 21, 2023): The article has been updated to clarify that tianeptine does not increase serotonin levels in the body. It either prevents re-uptake of serotonin like SSRI antidepressants or possibly enhances it to increase use of the hormone.

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This non-invasive device blasts apart tumors with sound waves https://www.popsci.com/technology/histosonics-tumor-sound-wave-fda-approval/ Sat, 14 Oct 2023 11:00:00 +0000 https://www.popsci.com/?p=579625
HistoSonics' tumor destroying device.
HistoSonics' tumor destroying device. Erica Bass, Rogel Cancer Center, Michigan Medicine

The tech recently received FDA approval, and will soon be available as a treatment option for patients in the US.

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HistoSonics' tumor destroying device.
HistoSonics' tumor destroying device. Erica Bass, Rogel Cancer Center, Michigan Medicine

This week, the US Food and Drug Administration gave the green light to a device that uses ultrasound waves to blast apart tumors in the liver. This technique, which requires no needles, injections, knives, or drugs, is called histotripsy, and it’s being developed by a company called HistoSonics, founded by engineers and doctors from the University of Michigan in 2009. 

According to a press release, this approval comes after the results of a series of clinical trials indicated that it can effectively destroy liver tumors while being safe for patients. Now hospitals can purchase the device and offer it to patients as a treatment option. The machine works by directing targeted pulses of high-energy ultrasound waves at a tumor, which creates clusters of microbubbles inside it. When the bubbles form and collapse, they stress the cells and tissues around them, allowing them to break apart the tumor’s internal structure, leaving behind scattered bits that the immune system can then come in to sweep up. 

Here’s the step-by-step process: After patients are under anesthesia, a treatment head that looks uncannily like a pair of virtual reality goggles is placed over their abdomen. Clinicians toggle through a control screen to look at and locate the tumor. Then they lock and load the sound waves. The process is reportedly fast and painless, and the recovery period after the procedure is short.

Through a paired imaging machine, clinicians can also see that the sound waves are targeted at the tumor while avoiding other parts of the body. A robotic arm can also move the transducer to get better aim at the tumor region. In this process, the patient’s immune system can also learn to recognize the tumor cells as threats, which prevented recurrence or metastasis in 80 percent of mice subjects.

While the approval of the device is a big step for broadening the options for cancer treatments, the use of sound waves in medicine is not new. Another platform called Exablate Prostate by Insightech was cleared by the FDA for human trials in prostate cancer patients (although clearance is not quite the same thing as an approval). Nonetheless, the results have been encouraging. The histotripsy technique is being applied in many preclinical experiments for tumors outside of the brain, such as in renal cancer, breast cancer, pancreatic cancer, and musculoskeletal cancer. 

Beyond tumors, a similar technique called lithotripsy, which uses shock waves, has been a treatment for breaking apart painful kidney stones so they become small enough for patients to pass. 

Watch the device at work below:

Engineering photo

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Titanium-fused bone tissue connects this bionic hand directly to a patient’s nerves https://www.popsci.com/technology/bionic-hand-phantom-pain/ Thu, 12 Oct 2023 15:00:00 +0000 https://www.popsci.com/?p=579098
Patient wearing a highly integrated bionic hand in between many others
The breakthrough bionic limb relies on osseointegration to attach to its wearer. Ortiz-Catalan et al., Sci. Rob., 2023

Unlike other prosthetics, a new model connects directly to a patient's limb via both bone and nerves.

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Patient wearing a highly integrated bionic hand in between many others
The breakthrough bionic limb relies on osseointegration to attach to its wearer. Ortiz-Catalan et al., Sci. Rob., 2023

Adjusting to prosthetic limbs isn’t as simple as merely finding one that fits your particular body type and needs. Physical control and accuracy are major issues despite proper attachment, and sometimes patients’ bodies reject even the most high-end options available. Such was repeatedly the case for a Swedish patient after losing her right arm in a farming accident over two decades ago. For years, the woman suffered from severe pain and stress issues, likening the sensation to “constantly [having] my hand in a meat grinder.”

Phantom pain is an unfortunately common affliction for amputees, and is believed to originate from nervous system signal confusions between the spinal cord and brain. Although a body part is amputated, the peripheral nerve endings remain connected to the brain, and can thus misread that information as pain.

[Related: We’re surprisingly good at surviving amputations.]

With a new, major breakthrough in prosthetics, however, her severe phantom pains are dramatically alleviated thanks to an artificial arm built on titanium-fused bone tissue alongside rearranged nerves and muscles. As detailed in a new study published via Science Robotics, the remarkable advancements could provide a potential blueprint for many other amputees to adopt such technology in the coming years.

The patient’s procedure started in 2018 when she volunteered to test a new kind of bionic arm designed by a multidisciplinary team of engineers and surgeons led by Max Ortiz Catalan, head of neural prosthetics research at Australia’s Bionics Institute and founder of the Center for Bionics and Pain Research. Using osseointegration, a process infusing titanium into bone tissue to provide a strong mechanical connection, the team was able to attach their prototype to the remaining portion of her right limb.

Accomplishing even this step proved especially difficult because of the need to precisely align the volunteer’s radius and ulna. The team also needed to account for the small amount of space available to house the system’s components. Meanwhile, the limb’s nerves and muscles needed rearrangement to better direct the patient’s neurological motor control information into the prosthetic attachment.

“By combining osseointegration with reconstructive surgery, implanted electrodes, and AI, we can restore human function in an unprecedented way,” Rickard Brånemark, an MIT research affiliate and associate professor at Gothenburg University who oversaw the surgery, said via an update from the Bionics Institute. “The below elbow amputation level has particular challenges, and the level of functionality achieved marks an important milestone for the field of advanced extremity reconstructions as a whole.”

The patient said her breakthrough prosthetic can be comfortably worn all day, is highly integrated with her body, and has even relieved her chronic pain. According to Catalan, this reduction can be attributed to the team’s “integrated surgical and engineering approach” that allows [her] to use “somewhat the same neural resources” as she once did for her biological hand.

“I have better control over my prosthesis, but above all, my pain has decreased,” the patient explained. “Today, I need much less medication.” 

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Viruses could be an unlikely ally in battling antibiotic-resistant bacteria https://www.popsci.com/health/antibiotic-resistance-phage-therapy/ Thu, 12 Oct 2023 11:00:00 +0000 https://www.popsci.com/?p=577258
Bacteriophage destroying antibiotic-resistant bacteria during phage therapy. Illustration.
Bacteriophages (like this computer-simulated one) can clear out infections in a way that antibiotics sometimes can't. NIAID

Experimental phage therapy offers a lifeline when antibiotics no longer work. Prostate infection survivor Gregory Breed is proof.

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Bacteriophage destroying antibiotic-resistant bacteria during phage therapy. Illustration.
Bacteriophages (like this computer-simulated one) can clear out infections in a way that antibiotics sometimes can't. NIAID

Gregory Breed doesn’t remember exactly when he began suffering from symptoms of a chronic prostate infection. The 62-year-old estimates they began when he was in his mid-20s. By his early 30s, he was taking painkillers for lower back pain, a common outcome of the disease. Over the years, his doctors put him on course after course of oral antibiotics: trimethoprim-sulfamethoxazole and levofloxacin. But a few months after he stopped taking the drugs, his infection would return.

Prostate infections or prostatitis, one of the most common urinary tract issues in adults, are notorious for recurrence as antibiotics often can’t penetrate tissue deep enough to kill all the bacteria. Over time, with repeated exposure to medicine, the E. coli causing Breed’s infection was becoming increasingly drug-resistant, meaning the bacteria developed the ability to evade and survive treatment. To make matters worse, Breed’s immune response was growing more severe. Between 2000 and 2010, he was hospitalized with sepsis, a life-threatening condition caused by the immune system’s overreaction to an infection, at least five times. Each time he would recover, only to battle another flare-up.

In 2018, Breed began feeling the familiar symptoms of prostatitis. He drove to his local health facility in Casper, Wyoming, where his doctor prescribed a new oral antibiotic: fosfomycin. Six months later, the E.coli in his prostate had developed resistance to that treatment too. It was the last drug that Breed could take orally; with no other options remaining, his doctors installed a catheter in his arm and taught him to administer intravenous antibiotics to himself.

Breed started his first round of IV antibiotic treatment, but the bacteria causing his infection quickly became resistant to that and then to a second IV antibiotic. When his infection came back the next time, Breed’s physician prescribed a third IV antibiotic that Breed fed into his veins three times a day. The new drug was only temporarily effective at reducing the E. coli in his prostate and couldn’t cure the infection. Breed’s physician estimates that his patient was on a different antibiotic regimen for some six months out of each year.

“Greg was constantly in the practice,” Ismail Jimada, Breed’s doctors between 2018 and 2022, says. “We were running out of solutions.”

Phage therapy patient Greg Breed with three grandchildren at a playground
Gregory Breed with his three grandchildren. He is one of the few prostatitis patients to try phage therapy. Courtesy of Greg Breed

Breed routinely maxed out his health insurance, paying thousands of dollars out of pocket for his medical bills. The infections took a toll on his loved ones and work life. “I have a very supportive family, but it was hard,” Breed recalls. “There were a lot of years there I didn’t get to be around my family near what I would have liked to.” Some days he struggled to get up and manage his small business selling pipes for oil wells. With limited options for medical care in rural Wyoming, he sought out infectious disease specialists across the country. But with the E. coli in his prostate already resistant to many go-to antibiotics, they didn’t have many treatments to offer him.

Breed’s infection was just one of more than 2.8 million cases of drug-resistant infections recorded by the Centers for Disease Control and Prevention in the US each year. Illnesses that defy antibiotics, antifungals, or other antimicrobials are challenging, if not altogether impossible to treat. More than 35,000 Americans die from drug-resistant infections annually. Globally, that number likely exceeds one million. In 2021 the World Health Organization declared antimicrobial resistance “one of the top 10 global public health threats facing humanity.” Antibiotics are a cornerstone of modern medicine; as pathogens like E. coli , Candida auris, and HIV develop a tolerance to the remedies, common infections, routine dental procedures, and surgeries could become life-threatening. Just in time, however, scientists and physicians are turning to an obscure, decades-old antidote to get drug-resistant infections back under control.

A race to replace antibiotics

Antimicrobial resistance is just another consequence of evolution: Bacteria, fungi, and other microorganisms are constantly adapting unique survival mechanisms to keep up with humans and a changing world. Still, researchers believe the overuse and misuse of antimicrobials in medicine and agriculture is accelerating the emergence and spread of resistance. New drugs capable of killing these evolving microbes could stave off the problem—but it takes millions of dollars and more than a decade of research and development to put out such a product. There hasn’t been a novel class of antibiotics since the 1980s, in part because most major pharmaceutical companies have stopped trying to discover one.

Out of desperation, Breed began scouring the internet for alternative treatments. Sometime in late 2017 or early 2018, he stumbled across a Ted talk by UC San Diego epidemiologist Steffanie Strathdee. In it, Strathdee describes an ill-fated trip to Egypt in 2015 where her husband, Tom Patterson, contracted a drug-resistant infection caused by Acinetobacter baumannii. When they arrived home in California, Patterson fell into a coma; his organs began to shut down. The bacteria behind his infection was already resistant to all known antibiotics.

Strathdee also turned to the internet and found a glimmer of hope: a treatment first discovered in 1917 that had been used in the Soviet Union for decades but largely overlooked by the rest of the world. The method taps bacteriophages, a type of virus that infects and kills bacteria, to combat infections. Scientists have long known that there are billions of different bacteriophages, or “phages,” on the planet. They often live in sewers and other germ-filled places and are highly specific, killing only one or sometimes a few strains of bacteria with no documented harm to humans.

Bacteriophages fighting antibiotic-resistant Acinetobacter baumannii under a microscope
A bacterial isolate from Tom Patterson that shows antibiotic-resistant Acinetobacter baumannii being attacked by phages that were identified by US Navy doctors. Patterson became the first patient to undergo intravenous phage therapy in the US, and successfully. Charles Pope/ US Department of Homeland Security

Strathdee reached out to scientists publishing phage research at the time. She thought if they could find a virus that could infect and kill the specific A. baumannii strain causing her husband’s infection, then he might have a chance to survive. Researchers at Texas A&M University immediately responded to her urgent e-mail and started hunting for the right type to combat the culprit. After just a few weeks, they found a few candidate specimens and mailed them to California. The treatment would be experimental—there were no known cases of intravenous phage therapy in the US at the time, according to Strathdee—so Patterson’s clinical team requested emergency use authorization from the Food and Drug Administration (FDA). It was granted within a day. At the UC San Diego Medical Center, doctors injected the phages into Patterson’s abdomen, and a few days later, directly into his bloodstream. Less than a week after the treatment began, Patterson woke up, kissed his daughter’s hand, and went on to make a full recovery.

Building a new path

In 2018, Strathdee co-founded the Center for Innovative Phage Applications and Therapeutics, or IPATH, at UC San Diego to further develop phage therapy for drug-resistant infections. Later that same year, Breed e-mailed the group inquiring if method might also work for his chronic prostate infection. The IPATH team got to work sending specimens of Breed’s E. coli to a network of phage researchers around the country, searching for an effective phage match for much of 2019. It was ultimately provided by the TAILOR lab at the Baylor College of Medicine, which creates “customized phage cocktails for no-hope cases when antibiotics and standard of care have failed,” its founder Anthony Maresso says. Then it took just about one day to receive compassionate use authorization from the FDA.

Bacteriophages in petri dishes at German Collection of Microorganisms and Cell Cultures
A research assistant at the German Collection of Microorganisms and Cell Cultures holds two Petri dishes filled with bacteriophages in her hands. The facility, located in Braunschweig, Germany, has supplied dozens of countries with specimens that can be propagated for phage therapy. Hauke-Christian Dittrich/picture alliance via Getty Images

In January 2020, Breed and his wife flew to San Diego to begin the phage treatment, which IPATH provided for free. “I was excited but extremely nervous about it. When you think about putting the substance they tell you the phage is derived from into your body, it’s not a real good thought,” Breed says. (He’s referring to sewage, the most common source for effective phages.) “Especially when they hook you up and say, ‘Okay, we’re gonna watch and see what happens,’ and you know there’s not a whole lot of people ahead of you who have done it. It’s a really scary situation to be in.”

The IPATH team injected phages into Breed’s catheter. For the next two weeks, he continued with the procedure twice a day, according to Saima Aslam, an infectious diseases physician and IPATH’s clinical lead. Breed’s symptoms—pain, fever, and urinary problems—faded. After six months, laboratory tests confirmed there was no detectable E. coli in his prostate. It has remained that way ever since, and Breed has not suffered any adverse effects from the undertaking.

In high demand

After his decades-long battle, Breed was finally cured. So, too, are a growing number of patients with drug-resistant infections. Phage therapy remains experimental in the US and can only be used in emergency or compassionate use cases when few or no other treatments are available. Data describing its effectiveness and safety remains limited: Results from single cases are not always consistently reported, and only a handful of clinical trials have been conducted. What’s more, across the few health centers now providing phage therapy, there are variations in how it’s administered—intravenously, orally, topically, or intranasally—and in patient-selection criteria. Despite these challenges, the emerging body of research consistently concludes that phage therapy is safe.

There are, however, mixed results regarding phage therapy’s ability to cure infections. One review published in 2022 summarized safety and efficacy findings from 13 clinical trials conducted around the world between 2005 and 2021. All the trials, including six tests that administered phages to healthy children and adults to compare them to sick patients, independently concluded that the remedy was safe. Only seven of the 13 studies assessed the clinical outcomes of sick patients who received phages to treat a variety of conditions from leg ulcers to ear infections. Only two consistently reported improvements in patients’ symptoms following phage therapy; the authors of the wider review note this may reflect a poor match between the selected phage and the bacteria it was meant to target.

A separate study published in 2023 reported that 11 of 20 patients in the US who received phage therapy for infections caused by mycobacterium had favorable clinical responses. The IPATH team itself has treated 18 patients, including Breed, with phage therapy in the past five years and has had a success rate of 82 percent, Aslam says. She and other physicians and phage researchers are calling for additional research and clinical trials to better understand phage therapy and set forth best practices. There are more than 20 ongoing clinical trials—many for people with cystic fibrosis or prosthetic joint infections—–registered with the US government now.

Bacteriophage that infects E. coli genetic material for phage therapy depicted by purple, pink, and green computer models
Computer models show how the bacteriophage T4 (left panel) attacks E. coli, which normally inhabits the gastrointestinal tract of humans. T4’s invasion starts by touching down on the bacterial cell wall and injecting viral DNA through its tube-like tail (purple) into the cell. A “packaging machine” (middle and right panels) between the bacteriophage’s “head” and “tail” (green, yellow, blue spikes) keeps the double-stranded DNA (middle panel, red) at the ready. Victor Padilla-Sanchez, The Catholic University of America, Washington, D.C.

The current ad-hoc model of sending samples to researchers across the country in hopes for a phage match often delays time to treatment. It usually takes about four to six months to scour repositories—or sewers—for a good phage match, Aslam explains, which means that patients should be in somewhat stable condition to be a candidate. (The FDA typically approves phage therapy for critically ill patients within 24 hours and for more stable patients within 30 days.) The method is also not sustainable for large-scale use. The US government and several universities around the world are working to compile databases that list their discovered phages and the bacterial strains they target. Several biotechnology companies with private collections have also sprung up in recent years; some researchers are even developing and patenting genetically modified phages that are shelf stable or can target more than one type of infection-causing bacteria.

While there is still a long road ahead, phage therapy is one of the few tested solutions for drug-resistant infections—and could some day be comparable, if not cheaper, to the cost of antibiotics. Aslam envisions that in the future, different phage products will be available at pharmacies just like other medicines. But for now, the therapy is proving lifesaving and life changing for lucky individuals like Breed and Patterson. “I have three young grandkids … I was to the point that I was wondering if I really was gonna enjoy the time with them,” Breed says. While he still has some lingering side effects from such prolonged antibiotic use, in terms of quality of life, “it is a thousand times better than it was” before the phages entered the battle.

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Centenarian blood tests give hints of the secrets to longevity https://www.popsci.com/health/blood-secrets-to-longevity/ Wed, 11 Oct 2023 10:00:00 +0000 https://www.popsci.com/?p=578327
How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know.
How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know. Deposit Photos

Those who made it to their hundredth birthday tended to have lower levels of glucose, creatinine and uric acid.

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How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know.
How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know. Deposit Photos

This article is republished from The Conversation.

Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s.

How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know. Plato and Aristotle discussed and wrote about the ageing process over 2,300 years ago.

The pursuit of understanding the secrets behind exceptional longevity isn’t easy, however. It involves unravelling the complex interplay of genetic predisposition and lifestyle factors and how they interact throughout a person’s life. Now our recent study, published in GeroScience,, has unveiled some common biomarkers, including levels of cholesterol and glucose, in people who live past 90.

Nonagenarians and centenarians have long been of intense interest to scientists as they may help us understand how to live longer, and perhaps also how to age in better health. So far, studies of centenarians have often been small scale and focused on a selected group, for example, excluding centenarians who live in care homes.

Huge dataset

Ours is the largest study comparing biomarker profiles measured throughout life among exceptionally long-lived people and their shorter-lived peers to date.

We compared the biomarker profiles of people who went on to live past the age of 100, and their shorter-lived peers, and investigated the link between the profiles and the chance of becoming a centenarian.

Our research included data from 44,000 Swedes who underwent health assessments at ages 64-99—they were a sample of the so-called Amoris cohort. These participants were then followed through Swedish register data for up to 35 years. Of these people, 1,224, or 2.7 percent, lived to be 100 years old. The vast majority (85 percent) of the centenarians were female.

Twelve blood-based biomarkers related to inflammation, metabolism, liver and kidney function, as well as potential malnutrition and anaemia, were included. All of these have been associated with ageing or mortality in previous studies.

The biomarker related to inflammation was uric acid—a waste product in the body caused by the digestion of certain foods. We also looked at markers linked to metabolic status and function including total cholesterol and glucose, and ones related to liver function, such as alanine aminotransferase (Alat), aspartate aminotransferase (Asat), albumin, gamma-glutamyl transferase (GGT), alkaline phosphatase (Alp) and lactate dehydrogenase (LD).

We also looked at creatinine, which is linked to kidney function, and iron and total iron-binding capacity (TIBC), which is linked to anaemia. Finally, we also investigated albumin, a biomarker associated with nutrition.

Findings

We found that, on the whole, those who made it to their hundredth birthday tended to have lower levels of glucose, creatinine and uric acid from their sixties onwards. Although the median values didn’t differ significantly between centenarians and non-centenarians for most biomarkers, centenarians seldom displayed extremely high or low values.

For example, very few of the centenarians had a glucose level above 6.5 earlier in life, or a creatinine level above 125.

For many of the biomarkers, both centenarians and non-centenarians had values outside of the range considered normal in clinical guidelines. This is probably because these guidelines are set based on a younger and healthier population.

When exploring which biomarkers were linked to the likelihood of reaching 100, we found that all but two (alat and albumin) of the 12 biomarkers showed a connection to the likelihood of turning 100. This was even after accounting for age, sex and disease burden.

The people in the lowest out of five groups for levels of total cholesterol and iron had a lower chance of reaching 100 years as compared to those with higher levels. Meanwhile, people with higher levels of glucose, creatinine, uric acid and markers for liver function also decreased the chance of becoming a centenarian.

In absolute terms, the differences were rather small for some of the biomarkers, while for others the differences were somewhat more substantial.

For uric acid, for instance, the absolute difference was 2.5 percentage points. This means that people in the group with the lowest uric acid had a 4 percent chance of turning 100 while in the group with the highest uric acid levels only 1.5 percent made it to age 100.

Even if the differences we discovered were overall rather small, they suggest a potential link between metabolic health, nutrition and exceptional longevity.

The study, however, does not allow any conclusions about which lifestyle factors or genes are responsible for the biomarker values. However, it is reasonable to think that factors such as nutrition and alcohol intake play a role. Keeping track of your kidney and liver values, as well as glucose and uric acid as you get older, is probably not a bad idea.

That said, chance probably plays a role at some point in reaching an exceptional age. But the fact that differences in biomarkers could be observed a long time before death suggests that genes and lifestyle may also play a role.The Conversation

Karin Modig is an associate professor of epidemiology at the Karolinska Institutet.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Many schools stock overdose reversal meds, but others worry about stigma https://www.popsci.com/health/schools-narcan-opioid-overdose-stigma/ Mon, 09 Oct 2023 01:00:00 +0000 https://www.popsci.com/?p=577045
Colorado has had a program that allows schools to obtain Narcan, typically in nasal spray form, for free or at a reduced cost.
Colorado has had a program that allows schools to obtain Narcan, typically in nasal spray form, for free or at a reduced cost. Deposit Photos

About nine states require at least some K-12 schools to store naloxone on-site.

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Colorado has had a program that allows schools to obtain Narcan, typically in nasal spray form, for free or at a reduced cost.
Colorado has had a program that allows schools to obtain Narcan, typically in nasal spray form, for free or at a reduced cost. Deposit Photos

This article was originally published on KFF Health News.

Last year, a student fell unconscious after walking out of a bathroom at Central High School in Pueblo, Colorado. When Jessica Foster, the school district’s lead nurse, heard the girl’s distraught friends mention drugs, she knew she had to act fast.

Emergency responders were just four minutes away. “But still four minutes — if they are completely not breathing, it’s four minutes too long,” Foster said.

Foster said she got a dose of naloxone, a medication that can rapidly reverse an opioid overdose, and gave it to the student. The girl revived.

Forty-five miles away in Colorado Springs, Mitchell High School officials didn’t have naloxone on hand when a 15-year-old student overdosed in class in December 2021 after snorting a fentanyl-laced pill in a school bathroom. That student died.

Colorado Springs’ school district has since joined Pueblo and dozens of other districts in the state in supplying middle and high schools with the lifesaving medication, often known by one of its brand names, Narcan. Since passage of a 2019 state law, Colorado has had a program that allows schools to obtain the medicine, typically in nasal spray form, for free or at a reduced cost.

Not all schools are on board with the idea, though. Though more districts have signed on since last year, only about a third of Colorado districts had enrolled in the state’s giveaway program at the start of this school year. And within the dozen counties with the highest drug overdose death rates in the state, many school districts had not signed up in the face of ongoing stigma around the need for the overdose reversal medication.

The federal Substance Abuse and Mental Health Services Administration recommends that schools, including elementary schools, keep naloxone on hand as fatal opioid overdoses rise, particularly from the potent drug fentanyl. And 33 states have laws that expressly allow schools or school employees to carry, store, or administer naloxone, according to Jon Woodruff, managing attorney at the Legislative Analysis and Public Policy Association, which tracks naloxone policies across the country.

Among those, about nine states require at least some K-12 schools to store naloxone on-site, including Illinois, whose requirement goes into effect in January. Some states, such as Maine, also require that public schools offer training to students in how to administer naloxone in nasal spray form.

Rhode Island requires all K-12 schools, both public and private, to stock naloxone. Joseph Wendelken, a spokesperson for the Rhode Island Department of Health, said in the past four years naloxone was administered nine times to people ages 10 to 18 in educational settings.

In early September, the medication also became available over the counter nationally, though the $45 price tag per two-dose package has some addiction specialists worried it will be out of reach for those who need it most.

But the medicine still isn’t as publicly widespread as automated external defibrillators or fire extinguishers. Kate King, president of the National Association of School Nurses, said reluctance to stock it in schools can stem from officials being afraid to provide a medical service or the ongoing cost of resupplying the naloxone and training people to use it. But the main hang-up she’s heard is that schools are afraid they’ll be stigmatized as a “bad school” that has a drug problem or as a school that condones bad choices.

“School districts are very careful regarding their image,” said Yunuen Cisneros, community outreach and inclusion manager at the Public Education & Business Coalition, which serves most of the state’s school districts. “Many of them don't want to accept this program, because to accept it is to accept a drug addiction problem.”

That’s the wrong way to think about it, King said. “We really equate it to our stock albuterol for asthma attacks, our stock epinephrine for anaphylactic reactions,” she said.

Colorado health officials could not say how often naloxone had been used on school grounds in the state. So far this year, at least 15 children ages 10 to 18 have died of fentanyl overdoses but not necessarily in schools. And in 2022, 34 children in that age group died, according to the state Department of Public Health and Environment. That included 13-year-old José Hernández, who died in August 2022 from a fentanyl overdose at home just days after starting eighth grade at Aurora Hills Middle School. His grandmother found his body over the bathroom sink in the early morning.

With the arrival of this new school year, supplies of naloxone are on hand for kids in more Colorado schools. Last year, state lawmakers appropriated $19.7 million in federal aid to the Naloxone Bulk Purchase Fund, which is accessible to school districts, jails, first responders, and community service organizations, among others.

“It’s the most we’ve ever had,” said Andrés Guerrero, manager of the state health department’s overdose prevention program.

According to data provided by Colorado’s health department, 65 school districts were enrolled in the state program to receive naloxone at low or no cost at the start of the school year. Another 16 had reached out to the state for information but hadn’t finalized orders as of mid-August. The remaining 97 school districts either didn’t stock naloxone at their schools or sourced it from elsewhere.

Guerrero said the districts decide whom to train to administer the medicine. “In some cases, it's just the school nurses. In some cases, it's school nurses and the teachers,” he said. “And in some cases, we have the students as well.”

In Durango, the 2021 death of a high schooler galvanized students to push for the right to carry naloxone with them to school with parental permission — and to administer it if need be — without fear of punishment.

It took picketing outside a school board meeting to get permission, said Hays Stritikus, who graduated this spring from Durango High School. He’s now involved in drafting legislation that would expressly allow students across the state to carry and distribute Narcan on school grounds.

“The ultimate goal is a world where Narcan is not necessary,” he said. “But that's just not where we live.”

Some health experts disagree that all schools should stock naloxone. Lauren Cipriano, a health economist at Western University in Canada, has studied the cost-effectiveness of naloxone in secondary schools there. While opioid poisonings have occurred on school grounds, she said, high schools tend to be really low-risk settings.

More effective strategies for combating the opioid epidemic are needle exchange sites, supervised drug consumption sites, and medication-assisted treatment that reduces cravings or mutes highs, Cipriano said. But those approaches can be expensive compared with naloxone distribution.

“When the state makes a big, free program like this, it looks like they're doing something about the opioid epidemic,” she said. “It's cheap and it looks like you're doing something, and that's, like, political gold.”

Denver Public Schools, the largest school district in Colorado, started stocking naloxone in 2022, said Jade Williamson, manager of the district’s healthy schools program.

"We know some of the students are on the forefront of these things before older generations,” Williamson said. “To know where to find it, and to access it when needed through these adults who've trained, whether that's a school nurse or a school administrator, I think it brings them some sense of relief."

The state’s seven largest districts, with more than 25,000 students each, all participate in the state program. By contrast, a KFF Health News analysis found, only 21 percent of districts with up to 1,200 students have signed up for it — even though many of those small districts are in areas with drug overdose death rates higher than the state average.

Some school districts figured out a path to getting naloxone outside of the state program. That includes Pueblo School District 60, where lead nurse Foster gave naloxone to a student last year.

The Pueblo school district gets naloxone at no cost from a local nonprofit called the Southern Colorado Harm Reduction Association. Foster said she tried signing up for the state program but encountered difficulties. So she decided to stick with what was already working.

Moffat County School District RE-1 in Craig, Colorado, gets its naloxone from a local addiction treatment center, according to district nurse Myranda Lyons. She said she trains school staffers on how to administer it when she teaches them CPR.

Christopher deKay, superintendent of Ignacio School District 11Jt, said its school resource officers already carry naloxone but that the district enrolled in the state program, too, so that schools could stock the medication in the nursing office in case a resource officer isn’t around.

“It’s like everything — like training for fire safety. You don’t know what’s going to happen in your school,” said deKay. “If the unthinkable happens, we want to be able to respond in the best way possible.”

This story was produced with reporting assistance from El Comercio de Colorado.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News' free Morning Briefing.

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A new noninvasive patch could monitor a vital hormone https://www.popsci.com/technology/sweat-sensor-hormones/ Thu, 05 Oct 2023 19:00:00 +0000 https://www.popsci.com/?p=577281
Sweat sensor worn like a ring on finger
The thin sensor measures estradiol, the most potent form of estrogen. Caltech

Estradiol is usually only measured via blood and urine samples, but this new patch only needs a little sweat.

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Sweat sensor worn like a ring on finger
The thin sensor measures estradiol, the most potent form of estrogen. Caltech

Wearable sensors can already monitor a variety of important health characteristics. But they are still far short when it comes to detecting hormonal levels, particularly for women. A new device designed by researchers at Caltech, however, is specifically tailored to measure one of women’s most vital and influential hormones. According to the team’s study, recently published in Nature Nanotechnology, their new wearable sensor can detect and assess users’ estradiol levels by just analyzing sweat droplets.

Estradiol, the most potent form of estrogen, is a crucial component in women’s health. Not only is it necessary in regulating reproductive cycles and ovulation, but this hormone’s levels are directly correlated to issues ranging from depression, to osteoporosis, to even heart disease. Currently, estradiol monitoring requires blood or urine samples collected either in-clinic or at-home. In contrast, Caltech’s new sensor, created by assistant professor of medical engineering Wei Gao, only needs miniscule amounts of sweat collected via extremely small automatic valves within its microfluidic system.

[Related: This organ-failure detector is thinner than a human hair.]

The sensor’s reliance on sweat to measure estradiol isn’t only impressive due to its non-invasive nature; according to Caltech’s announcement, the hormone is about 50 times less concentrated in sweat than in blood.

The wearable’s monitoring system utilizes aptamers—short, single-strand DNA capable of binding to target molecules like artificial antibodies. Gao’s team first attached aptamers to a surface imbued with inkjet-printed gold nanoparticles. The aptamers then could bind with targeted molecules—in this case, estradiol. Once connected, the molecule gets recaptured by other titanium carbide-coated gold nanoparticles known as “MXenes.” The resultant electrical signal can be wirelessly measured and correlated to estradiol levels via a simple-to-use smartphone app.

To actually collect the sweat samples, the sensor uses tiny channels controlled by automatic valves to allow only fixed amounts of fluid into the sensor. To take patients’ sweat composition differences into consideration, the device also consistently calibrates via information collected on salt levels, skin temperature, and sweat pH.

This isn’t Gao’s first sweat sensor, either—previous variants also could detect the stress hormone cortisol, COVID-19, as well as a biomarker that indicates inflammation.

“People often ask[ed] me if I could make the same kind of sweat sensor for female hormones, because we know how much those hormones impact women’s health,” Gao said via Caltech’s announcement. With further optimization, the new estradiol sensor could help users attempting to naturally or in vitro conceive children, as well as aid those necessitating hormone replacement therapies. According to Gao, the team also intends to expand the range of female hormones they can detect, including another ovulation-related variant, progesterone.

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DARPA wants to modernize how first responders do triage during disasters https://www.popsci.com/technology/darpa-triage-challenge/ Thu, 05 Oct 2023 13:00:00 +0000 https://www.popsci.com/?p=576638
mass-casualty triage occurring via different technologies
Ard Su for Popular Science

The Pentagon is looking for new ways to handle mass casualty events, and hopes that modern tech can help save more lives.

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mass-casualty triage occurring via different technologies
Ard Su for Popular Science

In Overmatched, we take a close look at the science and technology at the heart of the defense industry—the world of soldiers and spies.

IF A BUILDING COLLAPSES or a bomb goes off, there are often more people who need medical treatment than there are people who can help them. That mismatch is what defines a mass casualty incident. The military’s most famous R&D agency, DARPA, wants to figure out how to better handle those situations, so more people come out of them alive.

That’s the goal of what the agency is calling the DARPA Triage Challenge, a three-year program that kicks off November 6 and will bring together medical knowledge, autonomous vehicles, noninvasive sensors, and algorithms to prioritize and plan patient care when there are too many patients and not enough care—a process typically called triage. Teams, yet to be named, will compete to see if their systems can categorize injured people in large, complex situations and determine their need for treatment.

A sorting hat for disasters

Triage is no simple task, even for people who make it part of their profession, says Stacy Shackelford, the trauma medical director for the Defense Health Agency’s Colorado Springs region. Part of the agency’s mandate is to manage military hospitals and clinics. “Even in the trauma community, the idea of triage is somewhat of a mysterious topic,” she says. 

The word triage comes from the French, and it means, essentially, “sorting casualties.” When a host of humans get injured at the same time, first responders can’t give them all equal, simultaneous attention. So they sort them into categories: minimal, minorly injured; delayed, seriously injured but not in an immediately life-threatening way; immediate, severely injured in such a way that prompt treatment would likely be lifesaving; and expectant, dead or soon likely to be. “It really is a way to decide who needs lifesaving interventions and who can wait,” says Shackelford, “so that you can do the greatest good for the greatest number of people.”

The question of whom to treat when and how has always been important, but it’s come to the fore for the Defense Department as the nature of global tensions changes, and as disasters that primarily affect civilians do too. “A lot of the military threat currently revolves around what would happen if we went towards China or we went to war with Russia, and there’s these types of near-peer conflicts,” says Shackelford. The frightening implication is that there would be more injuries and deaths than in other recent conflicts. “Just the sheer number of possible casualties that could occur.” Look, too, at the war in Ukraine. 

The severity, frequency, and unpredictability of some nonmilitary disasters—floods, wildfires, and more—is also shifting as the climate changes. Meanwhile, mass shootings occur far too often; a damaged nuclear power plant could pose a radioactive risk; earthquakes topple buildings; poorly maintained buildings topple themselves. Even the pandemic, says Jeffrey Freeman, director of the National Center for Disaster Medicine and Public Health at the Uniformed Services University, has been a kind of slow-moving or rolling disaster. It’s not typically thought of as a mass casualty incident. But, says Freeman, “The effects are similar in some ways, in that you have large numbers of critically ill patients in need of care, but dissimilar in that those in need are not limited to a geographic area.” In either sort of scenario, he continues, “Triage is critical.”

Freeman’s organization is currently managing an assessment, mandated by Congress, of the National Medical Disaster System, which was set up in the 1980s to manage how the Department of Defense, military treatment facilities, Veterans Affairs medical centers, and civilian hospitals under the Department of Health and Human Services respond to large-scale catastrophes, including combat operations overseas. He sees the DARPA Triage Challenge as highly relevant to dealing with incidents that overwhelm the existing system—a good goal now and always. “Disasters or wars themselves are sort of unpredictable, seemingly infrequent events. They’re almost random in their occurrence,” he says. “The state of disaster or the state of catastrophe is actually consistent. There are always disasters occurring, there are always conflicts occurring.” 

He describes the global state of disaster as “continuous,” which makes the Triage Challenge, he says, “timeless.”

What’s more, the concept of triage, Shackelford says, hasn’t really evolved much in decades, which means the potential fruits of the DARPA Triage Challenge—if it pans out—could make a big difference in what the “greatest good, greatest number” approach can look like. With DARPA, though, research is always a gamble: The agency takes aim at tough scientific and technological goals, and often misses, a model called “high-risk, high-reward” research.

Jean-Paul Chretien, the Triage Challenge program manager at DARPA, does have some specific hopes for what will emerge from this risk—like the ability to identify victims who are more seriously injured than they seem. “It’s hard to tell by looking at them that they have these internal injuries,” he says. The typical biosignatures people check to determine a patient’s status are normal vital signs: pulse, blood pressure, respiration. “What we now know is that those are really lagging indicators of serious injury, because the body’s able to compensate,” Chretien says. But when it can’t anymore? “They really fall off a cliff,” he says. In other words, a patient’s pulse or blood pressure may seem OK, but a major injury may still be present, lurking beneath that seemingly good news. He hopes the Triage Challenge will uncover more timely physiological indicators of such injuries—indicators that can be detected before a patient is on the precipice.

Assessment from afar

The DARPA Triage Challenge could yield that result, as it tasks competitors—some of whom DARPA is paying to participate in the competition, and some of whom will fund themselves—with two separate goals. The first addresses the primary stage of triage (the sorting of people in the field) while the second deals with what to do once they’re in treatment. 

For the first stage, Triage Challenge competitors have to develop sensor systems that can assess victims at a distance, gathering data on physiological signatures of injury. Doing this from afar could keep responders from encountering hazards, like radioactivity or unstable buildings, during that process. The aim is to have the systems move autonomously by the end of the competition.

The signatures such systems seek may include, according to DARPA’s announcement of the project, things like “ability to move, severe hemorrhage, respiratory distress, and alertness.” Competitors could equip robots or drones with computer-vision or motion-tracking systems, instruments that use light to measure changes in blood volume, lasers that analyze breathing or heart activity, or speech recognition capabilities. Or all of the above. Algorithms the teams develop must then extract meaningful conclusions from the data collected—like who needs lifesaving treatment right now

The second focus of the DARPA Triage Challenge is the period after the most urgent casualties have received treatment—the secondary stage of triage. For this part, competitors will develop technology to dig deeper into patients’ statuses and watch for changes that are whispering for help. The real innovations for this stage will come from the algorithmic side: software that, for instance, parses the details of an electrocardiogram—perhaps using a noninvasive electrode in contact with the skin—looking at the whole waveform of the heart’s activity and not just the beep-beep of a beat, or software that does a similar stare into a pulse oximeter’s output to monitor the oxygen carried in red blood cells. 

For her part, Shackelford is interested in seeing teams incorporate a sense of time into triage—which sounds obvious but has been difficult in practice, in the chaos of a tragedy. Certain conditions are extremely chronologically limiting. Something fell on you and you can’t breathe? Responders have three minutes to fix that problem. Hemorrhaging? Five to 10 minutes to stop the bleeding, 30 minutes to get a blood transfusion, an hour for surgical intervention. “All of those factors really factor into what is going to help a person at any given time,” she says. And they also reveal what won’t help, and who can’t be helped anymore.

Simulating disasters

DARPA hasn’t announced the teams it plans to fund yet, and self-funded teams also haven’t revealed themselves. But whoever they are, over the coming three years, they will face a trio of competitions—one at the end of each year, each of which will address both the primary and secondary aspects of triage.

The primary triage stage competitions will be pretty active. “We’re going to mock up mass-casualty scenes,” says Chretien. There won’t be people with actual open wounds or third-degree burns, of course, but actors pretending to have been part of a disaster. Mannequins, too, will be strewn about. The teams will bring their sensor-laden drones and robots. “Those systems will have to, on their own, find the casualties,” he says. 

These competitions will feature three scenarios teams will cycle through, like a very stressful obstacle course. “We’ll score them based on how quickly they complete the test,” Chretien says, “how good they are at actually finding the casualties, and then how accurately they assess their medical status.” 

But it won’t be easy: The agency’s description of the scenarios says they might involve both tight spaces and big fields, full light and total darkness, “dust, fog, mist, smoke, talking, flashing light, hot spots, and gunshot and explosion sounds.” Victims may be buried under debris, or overlapping with each other, challenging sensors to detect and individuate them.

DARPA is also building a virtual world that mimics the on-the-ground scenarios, for a virtual version of the challenge. “This will be like a video-game-type environment but [with the] same idea,” he says. Teams that plan to do the concrete version can practice digitally, and Chretien also hopes that teams without all the hardware they need to patrol the physical world will still try their hands digitally. “It should be easier in terms of actually having the resources to participate,” he says. 

The secondary stage’s competitions will be a little less dramatic. “There’s no robotic system, no physical simulation going on there,” says Chretien. Teams will instead get real clinical trauma data, from patients hospitalized in the past, gathered from the Maryland Shock Trauma Center and the University of Pittsburgh. Their task is to use that anonymized patient data to determine each person’s status and whether and what interventions would have been called for when. 

At stake is $7 million in total prize money over three years, and for the first two years, only teams that DARPA didn’t already pay to participate are eligible to collect. 

Also at stake: a lot of lives. “What can we do, technologically, that can make us more efficient, more effective,” says Freeman, “with the limited amount of people that we have?” 

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mRNA vaccine innovators win the Nobel Prize in medicine https://www.popsci.com/health/nobel-prize-medicine-covid-19-mrna/ Mon, 02 Oct 2023 13:00:00 +0000 https://www.popsci.com/?p=576419
The 2023 Nobel Prize in Physiology or Medicine is jointly awarded to Katalin Karikó and Drew Weissman Katalin Karikó and Drew Weissman. This is an illustration of the two scientists.
The 2023 Nobel Prize in Physiology or Medicine is jointly awarded to Katalin Karikó and Drew Weissman Katalin Karikó and Drew Weissman. Niklas Elmehed/Nobel Prize Outreach

Katalin Karikó and Drew Weissman’s work was fundamental in developing COVID-19 vaccines and more.

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The 2023 Nobel Prize in Physiology or Medicine is jointly awarded to Katalin Karikó and Drew Weissman Katalin Karikó and Drew Weissman. This is an illustration of the two scientists.
The 2023 Nobel Prize in Physiology or Medicine is jointly awarded to Katalin Karikó and Drew Weissman Katalin Karikó and Drew Weissman. Niklas Elmehed/Nobel Prize Outreach

The 2023 Nobel Prize in medicine was awarded to Katalin Karikó and Drew Weissman, two of the scientists whose work helped pave the way for mRNA vaccines against COVID-19. Karikó is a biochemist from Sagan’s University in Hungary and an adjunct professor at the University of Pennsylvania. Karikó was also senior vice president and head of RNA protein replacement at BioNTech until 2022 and has been an advisor for the company. Weissman is a vaccine researcher at the University of Pennsylvania’s Perelman School of Medicine and Director of the Penn Institute for RNA Innovations.

[Related: How does an mRNA vaccine work?]

The prize is awarded by the Nobel Assembly of Sweden’s Karolinska Institute medical university and comes with its signature gold medicine and about $1 million (11 million Swedish crowns). 

“Through their groundbreaking findings, which have fundamentally changed our understanding of how mRNA interacts with our immune system, the laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the panel wrote in a press release

A potential game changer for vaccines

Previously, growing viruses, or at least pieces of viruses, were necessary to make a vaccine. The viruses were often cultivated in giant vats of cells or in or in chicken eggs, like the majority of flu shots. The viruses are then purified before being made into a vaccine.  

Using messenger RNA (mRNA) in vaccines is very different. It starts with a snippet of genetic code that brings instructions for making proteins. If the right virus protein is selected for the vaccine, then the body produces its own defenses against the virus. 

Genetic information encoded in DNA is transferred to mRNA, which is used as a blueprint for protein production in our cells. During the 1980s, efficient methods for producing mRNA without cell culture began. This process, called in vitro transcription, accelerated the development of molecular biology applications to several fields, but using mRNA technologies for vaccines had several roadblocks. In vitro transcribed mRNA was considered unstable and challenging to deliver since it required scientists to develop sophisticated carrier lipid systems to enclose the mRNA and produced some early inflammatory reactions. 

[Related: The FDA just green-lit America’s first COVID vaccine.]

Karikó was devoted to the idea of using mRNA for vaccines and other therapeutics during the 1990s when she became colleagues with Weissman. Weissman was interested in dendritic cells, which are important for immune surveillance and triggering vaccine-induced immune responses. 

The breakthrough

The two began to focus on how different RNA types interact with the immune system and noticed that the dendritic cells recognize in vitro transcribed mRNA as a foreign substance. This leads to their activation and release of inflammatory signaling molecules.mRNA from mammalian cells did not give rise to the same reaction,  the panel wrote. Different types of mRNA, therefore, must be distinguishable.

RNA contains four bases that are abbreviated A, U, G, and C. These letters correspond to the letters of genetic code in DNA A, T, G, and C. Karikó and Weissman knew that bases in RNA from mammalian cells are often chemically modified, and in vitro transcribed mRNA is not. They then wondered if the absence of altered bases in the in vitro transcribed RNA could explain unwanted inflammatory reactions. 

To learn more, they created different variants of mRNA which had unique chemical alterations at their bases. They delivered these to dendritic cells and the results were huge.  

The inflammatory response was almost wiped out when these base modifications were included in the mRNA. This was a seismic shift in scientific understanding of how cells recognize and respond to different forms of mRNA. . Their results were published in 2005.

mRNA contains four different bases, abbreviated A, U, G, and C. The Nobel Laureates discovered that base-modified mRNA can be used to block activation of inflammatory reactions (secretion of signaling molecules) and increase protein production when mRNA is delivered to cells.
mRNA contains four different bases, abbreviated A, U, G, and C. The Nobel Laureates discovered that base-modified mRNA can be used to block activation of inflammatory reactions (secretion of signaling molecules) and increase protein production when mRNA is delivered to cells. CREDIT: Mattias Karlén/The Nobel Committee for Physiology or Medicine.

COVID-19 and The Future

Interest in mRNA technology began to accelerate with their discovery. In 2010 several companies were working on developing the method for viruses such as Zika virus and MERS-CoV.

[Related: White House invests $5 billion in new COVID vaccines and treatments as national emergency ends.]

After the COVID-19 pandemic began, two base-modified mRNA vaccines encoding the SARS-CoV-2 surface protein were developed at a breakneck pace. Two highly effective vaccines were approved in December 2020.

One of the major advantages of mRNA technology was that vaccines could be made in extremely large quantities since their main components are made in laboratories, Exeter University infectious disease expert Bharat Pankhania told the Associated Press.  mRNA tech could be used to refine vaccines for diseases including Ebola, malaria, and dengue, as well as help immunize people against auto-immune diseases like lupus and even some types of cancer.

The laureates will receive their awards at ceremonies on December 10. The 2022 medicine prize was awarded to Svante Pääbo for sequencing the genome of the Neanderthal. Other past winners include Karl Landsteiner in 1930 for the discovery of human blood groups and co-winner Alexander Fleming for the discovery of penicillin in 1945.

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Afraid of needles? Check out this octopus-inspired drug patch. https://www.popsci.com/health/drug-delivery-patch-octopus-sucker/ Wed, 27 Sep 2023 18:00:00 +0000 https://www.popsci.com/?p=575194
An open mouth showing a drug delivery patch adhered to a cheek.
The drug delivery patch in a volunteer's mouth, with the strand of floss used as a safety requirement for the trial. ETH Zurich

The sucker-like device is a cheeky way to take your medicine.

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An open mouth showing a drug delivery patch adhered to a cheek.
The drug delivery patch in a volunteer's mouth, with the strand of floss used as a safety requirement for the trial. ETH Zurich

Needles are one of the best ways to quickly deliver a drug, but for many, getting jabbed is an unpleasant experience. One in four adults has an intense fear of needles, which could deter people from vaccines or treatments. In some cases—like those with diabetes—skipping out on insulin shots could be life-threatening. While there are other routes of administration, such as through the mouth, drugs containing proteins or large molecules may not be absorbed as well orally. Or they wind up digested in the gastrointestinal tract. Scientists are eager to find less invasive alternatives to needles that still get drugs where they need to go.

Jean-Christophe Leroux, a professor in drug formulation and delivery at ETH Zurich in Switzerland, has one idea: transform an injectable into an oral drug absorbed through the buccal mucosa, the lining of the inner cheek. However, past research attempts at using cheek patches were foiled by the mouth’s wet surface, which weakened adhesion. For inspiration, Leroux and his colleagues turned to a master of underwater suction—the octopus.

In a new study published today in Science Translational Medicine, senior author Leroux and his team replicated the suckers found at the end of an octopus’s arms. Using 3D printing, they created a rubbery but strong suction patch that delivers drugs through the inner cheek. The majority of participants in a small human trial reported that the suction patch was a comfortable fit and they would prefer this method to needle injections. 

“We have developed a very simple and easy to apply delivery system that could potentially replace injectables for several kinds of drugs,” Leroux says.

A sucker-shaped drug patch with a 1-cent coin for reference.
The sucker-shaped patch is a little smaller in diameter than a 1-cent coin. ETH Zurich

Octopuses use their grippy suckers to stay anchored in churning oceans or grab squirming prey.  “The starting point was mimicking the good suction these creatures had to strongly stick to wet surfaces,” Leroux adds.

Their sucker-based model has a few advantages over swallowing a pill. Because the delivery system is placed in a cheek for absorption over time, the patch can be removed if needed. The domed cup also protects the drugs inside from dissolving in saliva. 

A small trial in dogs showed drugs delivered by suction patch were effectively absorbed. The team applied patches, loaded with a diabetes tablet called desmopressin, to the mouths of three beagles. This peptide drug—a chain of amino acids—is poorly absorbed when taken orally. But after placing the suction patch, the researchers found higher concentrations of the drug in the dogs’ bodies. “We were really impressed by the level of absorption that we would get with such a simple system,” Leroux says. 

[Related: This pill delivers medication days or weeks after it’s swallowed]

Still, when compared with drug concentrations in the dogs after injections, the patches weren’t quite as effective. One upside, however, was that the dogs appeared to be more comfortable with the patch, which remained on their cheeks for three hours without falling off or causing irritation.

The research makes a significant advance in using the inner cheek as an administration site for peptides, says David Brayden, a professor of advanced drug delivery in the University College Dublin in Ireland who was not affiliated with the study. Previous attempts to apply drugs via cheeks mostly used doses of small molecules that are easily absorbed, but not larger peptides. “No buccal formulation or device has ever been approved for peptide administration, despite a 20-year effort,” he says.

Humans seemed to tolerate the patches, too. Forty adult volunteers wore  suction patches (loaded with water, not drugs) for 30 minutes. They added a strand of dental floss tied to the patch and people’s clothes to prevent  accidental swallowing. During that half-hour, the volunteers walked, talked, and rinsed their mouths. Thirty-five of the 40 patches stayed on; the study authors say the fallen five were probably placed improperly. 

An hour after applying the patch, 75 percent of people said they felt no discomfort. Examining  the inner cheeks with an endoscopic camera, the researchers saw no scarring or changes to the mouths’ tissue. About 92 percent of people found the suction patch generally comfortable. And nearly 83 percent said if they had to take a drug daily, they’d prefer using the patch over a needle.

[Related: This drug-delivery soft robot may help solve medical implants’ scar tissue problem]

“These are innovative studies that seek to identify new feasible methods and sites for [non-oral] drug delivery,” says Daniel Drucker, a professor of medicine at the University of Toronto in Canada who was not involved in the study. The canine trials showed the patch still has a pretty poor absorption of peptide drugs overall, he notes, but because people tolerated it so well, it could be an important foundation for  future approaches to chronic disease therapies. 

Larger safety trials—including wearing the device for longer than a half hour—will help refine how well people tolerate the patch. The researchers also need to show patients can wear it for simulated daily or weekly treatments. Once they have completed a larger safety trial, the next phase will be to test the effectiveness of the drug-loaded patch in people to assess how it compares with the absorption of pills and tablets. 

This drug delivery system could be publicly available in a few years, if all goes well, Leroux says. Or sooner: “We could potentially be even faster because of the simplicity of the technology and because we can use drugs that are already approved.”

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Neuralink’s human trials volunteers ‘should have serious concerns,’ say medical experts https://www.popsci.com/technology/neuralink-monkey-abuse/ Thu, 21 Sep 2023 18:00:00 +0000 https://www.popsci.com/?p=573344
Elon Musk in suit
New reports cite horrific, deadly medical complications for Neuralink's test monkey subjects. Chesnot/Getty Images

A medical ethics committee responded to Elon Musk's brain-interface startup issuing an open call for patients yesterday.

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Elon Musk in suit
New reports cite horrific, deadly medical complications for Neuralink's test monkey subjects. Chesnot/Getty Images

On Tuesday, Elon Musk’s controversial brain-computer interface startup Neuralink announced it received an independent review board’s approval to begin a six-year-long human clinical trial. Neuralink’s application for quadriplegic volunteers, particularly those suffering from spinal column injuries and ALS, is now open. Less than a day later, however, a Wired investigation revealed grisly details surrounding the deaths of the monkeys used in Neuralink’s experiments–deaths that Elon Musk has denied were directly caused by the implants. 

Almost simultaneously a medical ethics organization focused on animal rights filed a complaint with the Securities and Exchange Commission urging SEC to investigate Neuralink for alleged “efforts to mislead investors about the development history and safety of the device.” In Thursday’s email to PopSci, the committee urged potential Neuralink volunteers to reconsider their applications.

[Related: Neuralink is searching for its first human test subjects]

“Patients should have serious concerns about the safety of Neuralink’s device,” wrote Ryan Merkley, director of research advocacy for the committee, which was founded in 1985 and has over 17,000 doctor members. “There are well-documented reports of company employees conducting rushed, sloppy experiments in monkeys and other animals.”

According to Merkley and Wired’s September 20 report, Neuralink experiments on as many as 12 macaque monkeys resulted in chronic infections, paralysis, brain swelling, and other adverse side effects, eventually requiring euthanasia. The FDA previously denied Neuralink’s requests to begin human clinical trials, citing concerns regarding the implant’s electrodes migrating within the brain, as well as perceived complications in removing the device without causing brain damage. FDA approval was granted in May of 2023.

[Related: Neuralink human brain-computer implant trials finally get FDA approval]

Elon Musk first acknowledged some Neuralink test monkeys died during clinical trials on September 10, but denied their deaths were due to the experimental brain-computer interface implants. He did not offer causes of death, but instead claimed all monkeys chosen for testing were “close to death already.”

Wired’s investigation—based on public records, as well as interviews with former Neuralink employees and others—offers darker and often horrific accounts of the complications allegedly suffered by a dozen rhesus macaque test subjects between 2017 and 2020. In addition to neurological, psychological, and physical issues stemming from the test implants, some implants reportedly malfunctioned purely due to the mechanical installation of titanium plates and bone screws. In these instances, the cranial openings allegedly often grew infected and were immensely painful to the animals, and some implants became so loose they could be easily dislodged.

In his email to PopSci, Merkley reiterated the FDA’s past concerns regarding the Neuralink prototypes’ potential electrode migrations and removal procedures, and urged Musk’s company to “shift to developing a noninvasive brain-computer interface, where other researchers have already made progress.”

As Wired also notes, if the SEC takes action, it would be at least the third federal investigation into Neuralink’s animal testing procedures. Reuters detailed “internal staff complaints” regarding “hack job” operations on the test pigs in December 2022; last February, the US Department of Transportation opened its own Neuralink investigation regarding allegations of the company unsafely transporting antibiotic-resistant pathogens via “unsafe packaging and movement of implants removed from the brains of monkeys.”

During a Neuralink presentation last year, Musk claimed the company’s animal testing was never “exploratory,” and only focused on fully informed decisions. Musk repeatedly emphasized test animals’ safety, stressing that Neuralink is “not cavalier about putting devices into animals.” At one point, he contended that a monkey shown in a video operating a computer keyboard via Neuralink implant “actually likes doing the demo, and is not strapped to the chair or anything.”

“We are extremely careful,” he reassured his investors and audience at the time.

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Spider silk stronger than Kevlar spun by an unlikely source https://www.popsci.com/technology/silkworm-spider-crispr/ Thu, 21 Sep 2023 14:30:00 +0000 https://www.popsci.com/?p=573259
Scientists have manipulated the genes of a common silkworm to produce eco-friendlier silk that can be made into extra-strong materials.
Scientists have manipulated the genes of a common silkworm to produce eco-friendlier silk that can be made into extra-strong materials. DepositPhotos

Using CRISPR gene editing, researchers compelled common silkworms to produce material for durable new threads.

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Scientists have manipulated the genes of a common silkworm to produce eco-friendlier silk that can be made into extra-strong materials.
Scientists have manipulated the genes of a common silkworm to produce eco-friendlier silk that can be made into extra-strong materials. DepositPhotos

Researchers have coaxed common silkworms to spin a more durable, eco-friendlier spider silk—all it took was a few genetic modifications and hundreds of thousands of silkworm egg microinjections.

Synthetic commercial fabrics like nylon are notoriously harmful to the environment because of the carbon footprint from their production processes, as well as their tendency to shed microplastics during wash cycles. Although natural alternatives such as spider silk are incredibly attractive, farming spiders at an industrial scale is difficult given their comparatively low production rates, as well as their tendency to eat one another.

But what if another creature could produce ostensibly the same material in bulk, without all the cannibalism? Junpeng Mi’s team at Donghua University in Chinadid are moving towards that outcome using a combination of CRISPR gene editing and guided egg alterations, creating silkworms that spin silk identical to arachnids. As detailed in their paper recently published in Matter, the team’s breakthroughs have produced fibers which scientists claim are already six times tougher than bulletproof Kevlar.

[Related: A new kind of Kevlar aims to stop bullets with less material.]

In recent years, researchers have improved upon traditional silk’s durability, as well as created artificial spider silk. Even so, the latter’s manufacturing procedures weren’t great at applying a vital surface layer of lipids and glycoproteins to help the silk hold up to sunlight and humidity.

Mi’s team is the first to create silkworms whose excretions are ostensibly identical to spiders’ web material.

“Spider silk stands as a strategic resource in urgent need of exploration,” Mi said in a September 20 statement. “The exceptionally high mechanical performance of the fibers produced in this study holds significant promise in this field. This type of fiber can be utilized as surgical sutures, addressing a global demand exceeding 300 million procedures annually.”

[Related: Silkworm-inspired weaving techniques can produce better nanofibers.]

To create their silkworm-spider fibers, Mi and their fellow researchers first implanted spider silk protein genes from Araneus ventricosus, an East Asian orb-weaving spider, into silkworm DNA. From there, the team further modified the genetic makeup to ensure the transplanted proteins cooperated with silkworm glands to produce properly spun fibers.

The results went above and beyond the team’s hopes, offering a mix of high tensile strength and toughness alongside far more flexibility than anticipated. According to Mi’s team, the new silk manufacturing methods could boost advancements in biomedical engineering, aerospace technology, military capabilities, and other smart materials.

“This concept of ‘localization,’ introduced in this thesis, along with the proposed minimal structural model, represents a significant departure from previous research,” Mi said in their statement. “We are confident that large-scale commercialization is on the horizon.”

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Neuralink is searching for its first human test subjects https://www.popsci.com/technology/neuralink-human-test-search/ Wed, 20 Sep 2023 19:00:00 +0000 https://www.popsci.com/?p=573018
Elon Musk sitting with finger tips touching in steeple shape
Neuralink is looking for quadriplegic volunteers to test preliminary implant technology. Chesnot/Getty Images

After years of setbacks, investigations, and rejections, Elon Musk's brain-computer interface company says it's ready for human testing.

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Elon Musk sitting with finger tips touching in steeple shape
Neuralink is looking for quadriplegic volunteers to test preliminary implant technology. Chesnot/Getty Images

Neuralink, Elon Musk’s brain-computer interface startup, is seeking human volunteers to participate in its first clinical trial. In a September 19 announcement, the company says its Precise Robotically Implanted Brain-Computer Interface (PRIME) Study will test a “groundbreaking investigational medical device” in test subjects already suffering from quadriplegia due to amyotrophic lateral sclerosis (ALS) or cervical spinal cord injuries.

Once implanted via surgical robot using ultra-fine, flexible wiring, the preliminary BCI device reportedly will wirelessly transmit data to an external computer to decode patients’ movement intentions. Neuralink’s ultimate goal for the (PRIME) Study is to grant its volunteers the ability to wirelessly control a computer mouse or keyboard with their brains.

The company faced numerous setbacks leading up to the study’s final approval by an independent institutional review board and its first hospital site. Despite promises from Musk as far back as 2019 regarding the technology’s imminent arrival, Neuralink reportedly only first sought the FDA’s approval for human clinical testing approval in 2022. The regulatory body denied Neuralink’s request at the time, citing concerns over potential brain injuries resulting from BCI devices’ faulty wiring and overheating, as well as complications regarding its removability. In May, the FDA finally granted Neuralink an investigatory device exemption (IDE).

[Related: Neuralink’s request for human trials of brain implants was reportedly rejected by the FDA.]

But even before its applications to begin human clinical trials, Neuralink repeatedly drew ire from critics and watchdogs concerning its treatment of test animals. In a December 2022 Reuters exposé, “internal staff complaints” concerning animal welfare issues described “hack job” procedures resulting in over 1,500 dead test subjects since 2018. The report also revealed the employees’ accounts prompted the US Department of Agriculture’s Inspector General to launch a probe into the matter. Since then, the USDA’s investigation received its own share of criticism over bias and conflicts of interest.

Neuralink has so far demonstrated successful BCI integration with rats, as well as shared footage of a macaque monkey playing Pong via a wired prototype brain implant. Meanwhile, similar BCI devices have been in various development stages for years—some of which already achieve and surpass the goals for Neuralink’s PRIME Study. Earlier this year, researchers at Stanford University demonstrated devices that successfully translated an ALS patient’s thoughts to words to aid in communication. Meanwhile, another company backed by Jeff Bezos and Bill Gates announced in February 2023 that its researchers successfully implanted a “neuroprosthesis” device in four human subjects.

During a public Neuralink presentation in December 2022, Musk expressed hopes that human trials would begin within six months’ time.

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What makes a fever an infection-busting superpower https://www.popsci.com/health/how-fevers-fighr-infections/ Mon, 18 Sep 2023 01:00:00 +0000 https://www.popsci.com/?p=570714
Sick person with tan skin and black hair checking fever on a thermometer
Fevers are unpleasant, but they can help your body overcome invading pathogens. DepositPhotos

Even an increase of a few degrees can affect how well your body kills pathogens.

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Sick person with tan skin and black hair checking fever on a thermometer
Fevers are unpleasant, but they can help your body overcome invading pathogens. DepositPhotos

This article is republished from The Conversation.

Edmund K. LeGrand is an adjunct professor of biomedical and diagnostic sciences at the University of Tennessee and Joe Alcock is a professor of emergency medicine at the University of New Mexico.

When you’re sick with a fever, your doctor will likely tell you it’s a sign that your immune system is defending you against an infection. Fever typically results from immune cells at infected sites sending chemical signals to the brain to raise the set point of your body’s thermostat. So, you feel chills when the fever starts and feel hot when the fever breaks.

However, if you were to ask your doctor exactly how fever protects you, don’t expect a completely satisfactory answer.

Despite scientific consensus that fever is beneficial in fighting infections, exactly how is contentious. We are a veterinary pathologist and an emergency physician interested in applying evolutionary principles to medical problems. The evolution of fever is a classic conundrum because fever’s effects seem so harmful. Besides making you feel uncomfortable, you may also worry you’ll dangerously overheat. It is also metabolically costly to generate that much heat.

In our research and review, we propose that since fever occurs throughout much of the animal kingdom, this costly response must have benefits or it never would have evolved or been retained across species over time. We highlight several important but rarely considered points that help explain how the heat of fever helps your body fight infections.

How fever fights infection

Infections are caused by pathogens. Pathogens can be microbes such as certain species of bacteria, fungi or protozoans. If microbes or viruses have infected your cells and are using them to replicate, your own cells can also be considered pathogens and are treated that way by your immune system.

The main explanation for how fever helps control infections is that higher temperatures put heat-induced stress on pathogens, killing them or at least inhibiting their growth. But why would the somewhat higher body temperatures of fever—an increase of about 1.8 to 5.4 degrees Fahrenheit (1 to 4 degrees Celsius)—which can’t even kill your own healthy cells, harm such a wide variety of pathogens?

Immunologists have noted that slight heat makes immune cells work better. The implication is that fever is needed to enhance their defensive function. However, from an evolutionary perspective, it seems strange to require the massive energy cost of generating a fever just to get more activity from immune cells, especially since there are already plentiful and faster molecular signals available to activate them.

In addition to heat, slightly low oxygen levels and slight acidity also boost immune cell function. Since these stressful conditions also occur at infected sites, it makes sense that immune cells evolved to have their maximum functionality match their stressful working conditions. In fact, since anything in a state of growth is inherently vulnerable to stress—and pathogens are typically growing—researchers, including one of us, have proposed that a function of immune cells is to actively make local conditions stressful to preferentially harm the growing pathogens.

Diseases photo

Fever is a physiological response that has persisted for hundreds of millions of years across species.

Heating up pathogens locally

Inflammation is a local defensive response to infection. It typically involves heat, pain, redness and swelling in the areas where the immune system is most active. While some scientists are aware that infected sites generate heat, many believe that the feeling of warmth from inflammation is only from dilated blood vessels bringing in warmer blood from core body tissues.

However, researchers have found that inflamed tissues, even in core body tissues, are up to 1.8 to 3.6 degrees F (1 to 2 degrees C) warmer than adjacent normal tissues, so warmth is not just a byproduct of more blood flow. Much of that extra heat is coming from the immune cells themselves. When they generate reactive oxygen species to kill pathogens in a process known as the respiratory burst, substantial heat is also produced. To date, however, the temperatures involved have not been measured.

While cells can tolerate a wide range of temperatures, all cells experience a sharp decline in their ability to grow and survive at higher temperatures. For mammalian cells, and presumably the pathogens that infect them, even a single degree or two above temperatures around 113 degrees F (45 degrees C) is almost always deadly. So the heat of fever adds to already warmer local temperatures.

There is evidence that pathogens are exposed to temperatures that are much higher than the body temperature routinely measured with a thermometer in the emergency department. A 2018 study finding that local temperatures can be as high as 122 degrees F (50 degrees C) in mitochondria—the powerhouse of the cell—came as a surprise to researchers. The heat mitochondria generate is put to good use in warming the body and for fever. Likewise, we suggest that the local heat the respiratory burst produces at the surface of immune cells helps kill pathogens.

Heat and other stressors

Immune cells target pathogens with a variety of stressors meant to kill or inhibit them. These include reactive oxygen species, toxic peptides, digestive enzymes, high acidity and nutrient deprivation. Most chemical reactions are sped up by increased temperatures, so it isn’t surprising that heat enhances these defenses.

Researchers have shown heat to be synergistic with low oxygen and acidity in killing pathogens. Notably, neither febrile temperatures nor iron restriction on their own were able to inhibit the growth of the infectious bacteria Pasteurella multocida, but they could when combined. The stress of heat doesn’t act alone when controlling infections.

The standard view that the heat of fever kills pathogens and enhances immune responses is correct but incomplete. Fever’s ability to control infections comes from the few extra, but critical, degrees it adds to enhance existing locally generated heat to harm vulnerable growing pathogens. And fever also always acts with other defenses, never alone.

At more than 600 million years old, fever is an ancient feature of life on this planet that deserves respect. In fact, you owe it to infection-fighting heat that you are still here—alive—to read this. Something to think about the next time you’re sick.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Do I need a COVID booster? And all of your other questions answered. https://www.popsci.com/health/cdc-covid-booster-2023/ Fri, 15 Sep 2023 01:00:00 +0000 https://www.popsci.com/?p=570308
The number of hospitalized patients with covid has ticked up modestly in recent weeks.
The number of hospitalized patients with covid has ticked up modestly in recent weeks. DepositPhotos

The CDC has recommended new COVID-19 boosters for all.

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The number of hospitalized patients with covid has ticked up modestly in recent weeks.
The number of hospitalized patients with covid has ticked up modestly in recent weeks. DepositPhotos

This article was originally published on KFF Health News.

Everyone over the age of 6 months should get the latest covid-19 booster, a federal expert panel recommended Tuesday after hearing an estimate that universal vaccination could prevent 100,000 more hospitalizations each year than if only the elderly were vaccinated.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17 percent of the U.S. population got it—compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who should get the covid booster?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower—though not zero—for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When should you get it?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who will pay for it?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines. For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will this new booster work against the current variants of covid?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why are some doctors not gung-ho about the booster?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism. Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection—in most people. Many doctors think the focus should be on vaccinating those truly at risk.

With new covid boosters, plus flu and RSV vaccines, how many shots should I expect to get this fall?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine—for older adults—against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said. Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year.

Has this booster version been used elsewhere in the world?

Nope, although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Turmeric may help stomach aches, study shows https://www.popsci.com/health/turmeric-stomach-medicine/ Wed, 13 Sep 2023 13:00:00 +0000 https://www.popsci.com/?p=569970
The beloved spice has long been touted for health benefits.
The beloved spice has long been touted for health benefits. DepositPhotos

The golden spice isn’t a silver bullet quite yet.

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The beloved spice has long been touted for health benefits.
The beloved spice has long been touted for health benefits. DepositPhotos

Turmeric seems to be everywhere these days—on spice shelves, sprinkled on lattes, in beauty products. While the beloved golden spice has long been touted for health benefits, albeit not always backed up by extensive research, a new study in BMJ Evidence-Based Medicine found that turmeric shows signs of being just as or more effective for indigestion than some conventional over-the-counter drug options.

The study, led by Krit Pongpruil, an associate professor of preventative and social medicine at Thailand’s Chulalongkorn University, randomly assigned 206 patients between the ages of 18 and 70 with recurrent upset stomachs into three treatment groups. One group got two large capsules of curcumin, a naturally active component to turmeric and a dummy capsule, another got a small omeprazole capsule and two summy capsules four times a day, and the last group got omeprazole and turmeric capsules. 

Omeprazole is a common treatment for stomach problems such as acid reflux and ulcers. It works as a proton pump inhibitor, which reduces the amount of acid made by stomach glands, but can also cause health concerns after long term use, like micronutrient deficiencies and fracture risks, according to the study authors. 

[Related: For decades, turmeric’s ultra-golden glow had a deadly secret.]

Assessments were taken after days 28 and 56, and the researchers found that the results between the three groups were similar, which points to the efficacy of turmeric, according to the authors. “The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects,” they wrote in their findings. 

Of course, this study should be taken with a grain of salt, especially since the group of patients was so small. “I don’t think this one study alone is enough for me to say, ‘I recommend this,’” Yuying Luo, a gastroenterologist and assistant professor of gastroenterology at the Icahn School of Medicine at Mount Sinai, told CNN. “Proceed with caution.” It’s crucial to also check with your doctor to make sure that turmeric doesn’t interact poorly with any other medicines before taking it—some case studies have linked curcumin and liver injury, Luo told CNN.

Further studies are needed to see if a taste of turmeric could replace or supplement medicines to help with gastrointestinal issues and more (and if you need to take it in pill form for the effects to kick in). Until then, enjoy your favorite heartily-spiced, turmeric-filled foods, but don’t expect them to make your stomach problems vanish.

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This organ-failure detector is thinner than a human hair https://www.popsci.com/technology/kidney-transplant-sensor/ Fri, 08 Sep 2023 17:00:00 +0000 https://www.popsci.com/?p=568863
Kidney transplant sensor on researcher fingertip
The new sensor is thinner than a single human hair. Northwestern University

A new medical sensor can measure kidney temperature fluctuations as small as 0.004 degrees Celsius.

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Kidney transplant sensor on researcher fingertip
The new sensor is thinner than a single human hair. Northwestern University

Human bodies can reject organ transplants at any time—sometimes even years after the procedure itself. When this occurs, time is of the essence to potentially save not only the organ’s viability, but the life of a patient. Unfortunately, noticeable symptoms of organ rejection can show up late, but a tiny new medical device is showing immense promise in offering dramatically earlier detection times.

As detailed in a new study published September 8 in the journal Science researchers at Northwestern University have developed an ultra-thin, soft implant that adheres directly to a transplanted organ’s surface to monitor its health. In small animal clinical trials involving kidney transplants, rejection warning signs were identified as much as three weeks earlier than current methods.

[Related: The first successful pig heart transplant into a human was a century in the making.]

“I have noticed many of my patients feel constant anxiety—not knowing if their body is rejecting their transplanted organ or not. They may have waited years for a transplant… [t]hen, they spend the rest of their lives worrying about the health of that organ,” Lorenzo Gallon, a transplant nephrologist at Northwestern Medical who led the study’s clinical portion, said in a statement. “Our new device could offer some protection, and continuous monitoring could provide reassurance and peace of mind.”

According to John A. Rogers, a bioelectronics expert who led device development for the project, identifying rejection earlier can allow physicians to administer various therapies to prevent a patient from losing the organ, or even their lives.

“In worst-case scenarios, if rejection is ignored, it could be life threatening,” Rogers said via Friday’s statement. “The earlier you can catch rejection and engage therapies, the better. We developed this device with that in mind.”

Biology photo

At 0.3 cm wide, 0.7 cm long, and just 220 microns thick, the new sensor is thinner than a single human hair and smaller than your pinky fingernail. The device’s tininess is key to its ability to adhere, slipping beneath a kidney’s fibrous renal capsule layer to rest directly against the organ. Once positioned, the device’s extremely sensitive thermometer measures kidney temperature fluctuations as miniscule as 0.004 degrees Celsius. A miniature coin cell battery currently powers the device alongside Bluetooth capabilities to wireless stream data results to researchers.

Since tissue inflammation is often an early sign of complications, researchers were alerted much faster to potential problems than currently available detection methods like creatine and blood urea monitoring. Due to normal body fluctuations, those existing options are also far less reliable and sensitive than the new device.

“Bodies move, so there is a lot of motion to deal with. Even the kidney itself moves,” Rogers continued, explaining that the organ’s soft tissue isn’t ideal for suturing. “These were daunting engineering challenges, but this device is a gentle, seamless interface that avoids risking damage to the organ.”

Moving forward, the team intends to begin larger animal trials, along with potentially expanding to test on organs such as livers and lungs. They also hope to integrate new power sources capable of externally recharging the device’s battery, thus offering a more permanent monitoring solution.

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How to avoid getting COVID again https://www.popsci.com/health/how-to-avoid-covid-reinfection/ Tue, 05 Sep 2023 16:01:36 +0000 https://www.popsci.com/?p=567934
Kid with blonde hair wearing a blue COVID mask holding books and a backpack on the first day of school
COVID is making a comeback as kids head to school again. Deposit Photos

Though the virus may become endemic, updated vaccines can protect us from evolving variants.

The post How to avoid getting COVID again appeared first on Popular Science.

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Kid with blonde hair wearing a blue COVID mask holding books and a backpack on the first day of school
COVID is making a comeback as kids head to school again. Deposit Photos

With the changing weather comes virus season. Throughout the pandemic, infectious disease experts have seen an uptick in COVID cases during the fall and winter as more people stay indoors. The latter half of the year is also the time when SARS-CoV-2 mutates into other variants. And this year is no exception. Researchers are keeping an eye on the new variant BA.2.86, or Pirola, as it spreads in multiple countries. Meanwhile, back in August, the Centers for Disease Control and Prevention (CDC) announced a new Omicron variant called Eris had become the dominant coronavirus strain in the US.

“The Eris variant appears to be more transmissible compared to prior variants, which may mean that it will be easier for more people to get infected from a given exposure. Also, people who have previously been infected or vaccinated may get infected with this new variant,” says Sherrill Brown, a medical director of infection prevention at AltaMed in California. 

Though Eris has been responsible for an increasing number of COVID hospitalizations in the US, infectious disease experts have not seen signs yet that it causes more severe illness. In fact, Brown says the Eris variant appears no more dangerous than the ones we’ve faced in the past.

With long COVID complications and immunocompromised individuals in mind as well, it doesn’t hurt to stay prepared if cases surge through the end of 2023. Like the flu and other respiratory viruses, some health experts are now calling COVID endemic—the average person will probably get it several times in their life. But the good news is the US is in a much better position now than three years ago with a range of preventative methods, from medical-grade masks and antiviral treatments to updated vaccine formulas. In mid-September, the Food and Drug Administration approved new booster shots, which are tweaked to defend against XBB.1.5, an Omicron variant.

Following an advisory committee vote in favor of this Omicron-targeting vaccine, the CDC is encouraging everyone who is eligible to get a shot for the upcoming fall and winter season. “We have more tools than ever to prevent the worst outcomes from COVID-19,” said CDC director Mandy Cohen in a news release. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

Is it time to mask up again?

The US government has lifted all masking mandates, so there is no requirement to wear one in public anymore. That said, private businesses and hospitals may demand face coverings on their property if there is another COVID wave.

For the most part, the decision to mask is personal. Sarah Hochman, the section chief of infectious diseases at NYU Langone Tisch Hospital, says people need to evaluate how far they’re willing to risk getting sick. A person who is immunocompromised or has other lung conditions like asthma, for example, may want to start masking up again because the risk of COVID complications in this group is higher. If you’re planning to see friends and family this season, a properly placed mask would tremendously reduce the risk of infection. “It has been a personal choice for the past year and a half and everyone has their own threshold on where they are concerned enough to mask in situations,” Hochman notes. Masking is also helpful in general for protecting against other respiratory viruses such as the flu and RSV.

[Related: Masks can work—even if you’re the only one wearing them]

A good way to evaluate your individual risk is to check the latest numbers of COVID hospitalization in your local area. Hochman says hospital data is a more reliable source of information given that the CDC and local health departments have not been reporting recently as much on case numbers; people can find these stats on their local state or county health department’s website. Additionally, regional or national data could be inaccurate because more people are doing home tests or not testing at all. In most places, however, hospitalized patients are still being tested for the virus. “It’s really more of a tip of the iceberg type of measure because you’re only measuring COVID in the sickest patients, but it can still indicate what’s going on,” Hochman explains.

When will new COVID boosters be available?

The Biden administration is looking at a mid-September rollout date for the new boosters. The bivalent COVID shot currently protects against the original coronavirus and two Omicron variants, BA.4 and BA.5. With the new update, the vaccine will include protection against the Omicron variant XBB.1.5. 

Eris is a close but not exact match to XBB.1.5 as it is a descendent of XBB.1.9.2. Still, infectious disease experts have a strong suspicion the new shots will provide some protection against this new variant. “Most of the circulating variants are still related to the XBB.1.5 strain, so there should be fairly good protection from severe disease with this updated vaccine,” says Brown.

Once the booster becomes publicly available, you can get it in the same places you received your prior vaccines, including doctor’s offices, pharmacies, and local health clinics. Some states and counties may have websites set up to help people find a vaccine administration center close to them. Remember that all COVID vaccines should still be free, regardless of insurance or immigration status. 

What happens if you get COVID again?

Masks and boosters cut your risk for re-infection, but they won’t completely prevent it. To prepare, make sure to keep some at-home rapid test kits on hand. Hochman recommends having one to two tests for every person in the household. 

[Related: How to check if your at-home COVID test has expired]

If you test positive, notify your doctor immediately. They can prescribe you the antiviral pill Paxlovid, which is most effective within five days of developing symptoms. You’ll also want to take time off work and other obligations to rest and drink enough fluids for a proper recovery. 

Isolate from others at home for at least five days to avoid spreading the virus. If you need to go out or see other people, make sure to wear a high-quality mask.

This post has been updated to include more regulatory information about this fall’s COVID boosters. It was originally published on September 5.

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Should doctors and nurses discuss the dangers of heat? https://www.popsci.com/health/medical-risk-heat-doctors/ Mon, 04 Sep 2023 01:00:00 +0000 https://www.popsci.com/?p=567562
Doctor and patient in office
The pilot program aims to remind clinicians to start talking to patients about how to protect themselves on dangerously hot days, which are happening more frequently because of climate change. DepositPhotos

Heat is already the leading cause of death in the U.S. from weather-related hazards.

The post Should doctors and nurses discuss the dangers of heat? appeared first on Popular Science.

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Doctor and patient in office
The pilot program aims to remind clinicians to start talking to patients about how to protect themselves on dangerously hot days, which are happening more frequently because of climate change. DepositPhotos

This article is from a partnership that includes WBUR, NPR, and KFF Health News.

An important email appeared in the inboxes of a small group of health care workers north of Boston as this summer started. It warned that local temperatures were rising into the 80s.

An 80-plus-degree day is not sizzling by Phoenix standards. Even in Boston, it wasn’t high enough to trigger an official heat warning for the wider public.

But research has shown that those temperatures, coming so early in June, would likely drive up the number of heat-related hospital visits and deaths across the Boston region.

The targeted email alert the doctors and nurses at Cambridge Health Alliance in Somerville, Massachusetts, got that day is part of a pilot project run by the nonprofit Climate Central and Harvard University’s Center for Climate, Health, and the Global Environment, known as C-CHANGE.

Medical clinicians based at 12 community-based clinics in seven states — California, Massachusetts, North Carolina, Oregon, Pennsylvania, Texas, and Wisconsin — are receiving these alerts.

At each location, the first email alert of the season was triggered when local temperatures reached the 90th percentile for that community. In a suburb of Portland, Oregon, that happened on May 14 during a springtime heat wave. In Houston, that occurred in early June.

A second email alert went out when forecasts indicated the thermometer would reach the 95th percentile. For Cambridge Health Alliance primary care physician Rebecca Rogers, that second alert arrived on July 6, when the high hit 87 degrees.

The emails remind Rogers and other clinicians to focus on patients who are particularly vulnerable to heat. That includes outdoor workers, older adults, or patients with heart disease, diabetes, or kidney disease.

Other at-risk groups include youth athletes and people who can’t afford air conditioning, or who don’t have stable housing. Heat has been linked to complications during a pregnancy as well.

“Heat can be dangerous to all of us,” said Caleb Dresser, director of health care solutions at C-CHANGE. “But the impacts are incredibly uneven based on who you are, where you live, and what type of resources you have.”

The pilot program aims to remind clinicians to start talking to patients about how to protect themselves on dangerously hot days, which are happening more frequently because of climate change. Heat is already the leading cause of death in the U.S. from weather-related hazards, Dresser said. Letting clinicians know when temperatures pose a particular threat to their patients could save lives.

“What we’re trying to say is, ‘You really need to go into heat mode now,’” said Andrew Pershing, vice president for science at Climate Central, with a recognition that “it’s going to be more dangerous for folks in your community who are more stressed.”

“This is not your grandmother’s heat,” said Ashley Ward, who directs the Heat Policy Innovation Hub at Duke University. “The heat regime that we are seeing now is not what we experienced 10 or 20 years ago. So we have to accept that our environment has changed. This might very well be the coolest summer for the rest of our lives.”

The alerts bumped heat to the forefront of Rogers’ conversations with patients. She made time to ask each person whether they can cool off at home and at work.

That’s how she learned that one of her patients, Luciano Gomes, works in construction.

“If you were getting too hot at work and maybe starting to feel sick, do you know some things to look out for?” Rogers asked Gomes.

“No,” said Gomes slowly, shaking his head.

Rogers told Gomes about early signs of heat exhaustion: dizziness, weakness, or profuse sweating. She handed Gomes tip sheets she’d printed out after receiving them  along with the email alerts.

They included information about how to avoid heat exhaustion and dehydration, as well as specific guidance for patients with asthma, chronic obstructive pulmonary disease (COPD), dementia, diabetes, multiple sclerosis, and mental health concerns.

Rogers pointed out a color chart that ranges from pale yellow to dark gold. It’s a sort of hydration barometer, based on the color of one’s urine.

“So if your pee is dark like this during the day when you’re at work,” she told Gomes, “it probably means you need to drink more water.”

Gomes nodded. “This is more than you were expecting to talk about when you came to the doctor today, I think,” she said with a laugh.

During this visit, an interpreter translated the visit and information into Portuguese for Gomes, who is from Brazil and quite familiar with heat. But he now had questions for Rogers about the best ways to stay hydrated.

“Because here I’ve been addicted to soda,” Gomes told Rogers through the interpreter. “I’m trying to watch out for that and change to sparkling water. But I don’t have much knowledge on how much I can take of it.”

“As long as it doesn’t have sugar, it’s totally good,” Rogers said.

Now Rogers creates heat mitigation plans with each of her high-risk patients. But she still has medical questions that the research doesn’t yet address. For example: If patients take medications that make them urinate more often, could that lead to dehydration when it’s hot? Should she reduce their doses during the warmest weeks or months? And, if so, by how much? Research has yielded no firm answers to those questions.

Deidre Alessio, a nurse practitioner at Cambridge Health Alliance, also has received the email alerts. She has patients who sleep on the streets or in tents and search for places to cool off during the day.

“Getting these alerts makes me realize that I need to do more homework on the cities and towns where my patients live,” she said, “and help them find transportation to a cooling center.”

Most clinics and hospitals don’t have heat alerts built into electronic medical records, don’t filter patients based on heat vulnerability, and don’t have systems in place to send heat warnings to some or all of their patients.

“I would love to see health care institutions get the resources to staff the appropriate outreach,” said Gaurab Basu, a Cambridge Health Alliance physician who co-directs the Center for Health Equity Advocacy and Education at Cambridge Health Alliance. “But hospital systems are still really strained by covid and staffing issues.”

This pilot program is an excellent start and could benefit by including pharmacists, said Kristie Ebi, founding director of the Center for Health and the Global Environment at the University of Washington.

Ebi has studied heat early-warning systems for 25 years. She says one problem is that too many people don’t take heat warnings seriously. In a survey of Americans who experienced heat waves in four cities, only about half of residents took precautions to avoid harm to their health.

“We need more behavioral health research,” she said, “to really understand how to motivate people who don’t perceive themselves to be at risk, to take action.”

For Ebi and other researchers, the call to action is not just to protect individual health, but to address the root cause of rising temperatures: climate change.

“We’ll be dealing with increased exposure to heat for the rest of our lives,” said Dresser. “To address the factors that put people at risk during heat waves, we have to move away from fossil fuels so that climate change doesn’t get as bad as it could.”

This article is from a partnership that includes WBUR, NPR, and KFF Health News.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

Climate Change photo

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This drug-delivery soft robot may help solve medical implants’ scar tissue problem https://www.popsci.com/technology/soft-robot-drug-ai/ Thu, 31 Aug 2023 16:00:00 +0000 https://www.popsci.com/?p=567276
Professor Garry Duffy and Dr Rachel Beatty show the soft robotic implant developed by University of Galway and MIT
The implant uses mechanotherapy to adjust its shape and size, thus avoiding scar tissue buildup. Martina Regan

The new design could one day provide continuous, consistent drug dispersal without succumbing to fibrosis complications.

The post This drug-delivery soft robot may help solve medical implants’ scar tissue problem appeared first on Popular Science.

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Professor Garry Duffy and Dr Rachel Beatty show the soft robotic implant developed by University of Galway and MIT
The implant uses mechanotherapy to adjust its shape and size, thus avoiding scar tissue buildup. Martina Regan

Scar tissue, also known as fibrosis, is the scourge of medical device implants. Even when receiving potentially life saving drug treatments, patients’ bodies often form scarring around the foreign object, thus eventually forcing the implant to malfunction or fail. This reaction can drastically limit a procedure’s efficacy, but a new breakthrough combining soft robotics and artificial intelligence could soon clear the troublesome hurdle.

According to a new study published with Science Robotics, a collaboration between researchers at MIT and the University of Galway resulted in new medical device tech that relies on AI and a malleable body to evade scar tissue buildup. 

“Imagine a therapeutic implant that can also sense its environment and respond as needed using AI,” Rachel Beatty, co-lead author and postdoctoral candidate at the University of Galway, said in a statement. “This approach could generate revolutionary changes in implantable drug delivery for a range of chronic diseases.”

The technology’s secret weapon is its conductive, porous membrane capable of detecting when it is becoming blocked by scar tissue. When this begins to occur, a machine learning algorithm kicks in to oversee an emerging treatment known as mechanotherapy, in which soft robotic implants inflate and deflate at various speeds and sizes to deter scar tissue formation.

[Related: A micro-thin smart bandage can quickly heal and monitor wounds.]

Ellen Roche, an MIT professor of mechanical engineering and study co-author, explains that personalized, precision drug delivery systems could greatly benefit from responding to individuals’ immune system responses. Additionally, such devices could reduce “off-target effects” while ensuring the right drug dosages are delivered at the right times.

“The work presented here is a step towards that goal,” she added in a statement.

In training simulations, the team’s device could develop personalized, consistent dosage regimes in situations involving significant fibrosis. According to researchers, the new device’s AI could effectively control drug release even in a “worst-case scenario of very thick and dense scar tissue,” per the August 31 announcement.

According to Garry Duffy, the study’s senior author and a professor of anatomy and regenerative medicine at the University of Galway, the team initially focused on using the new robot for diabetes treatment. “Insulin delivery cannulas fail due to the foreign body response and have to be replaced often (approx. every 3-5 days),” told PopSci via email. “If we can increase the longevity of the cannula, we can then maintain the cannula for longer with less changes of the set required by the person living with diabetes.”

Beyond diabetes, they envision a future where the device can be easily adapted to a variety of medical situations and drug delivery regimens. According to Duffy, the advances could soon “provide consistent and responsive dosing over long periods, without clinician involvement, enhancing efficacy and reducing the need for device replacement because of fibrosis,” he said in the August 31 statement.

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AI may influence whether you can get pain medication https://www.popsci.com/health/artificial-intelligence-pain-medication/ Thu, 31 Aug 2023 01:00:00 +0000 https://www.popsci.com/?p=567011
Doctor pouring pills in hand from bottle.
Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide. Deposit Photos

New tools can help medical providers review controlled substance prescriptions, but experts are wary.

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Doctor pouring pills in hand from bottle.
Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide. Deposit Photos

This article originally published on KFF Health News.

Elizabeth Amirault had never heard of a Narx Score. But she said she learned last year the tool had been used to track her medication use.

During an August 2022 visit to a hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain, she said. She received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like Narx Scores are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. Narx Scores and an algorithm-generated overdose risk rating are produced by health care technology company Bamboo Health (formerly Appriss Health) in its NarxCare platform.

Such systems are designed to fight the nation’s opioid epidemic, which has led to an alarming number of overdose deaths. The platforms draw on data about prescriptions for controlled substances that states collect to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials, and health care providers have enlisted these tools, but the mechanics behind the formulas used are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work.

Lacking the ability to see inside these systems leaves only clues to their potential impact. Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened. Researchers warn that such technology — despite its benefits — can have unforeseen consequences if it improperly flags patients or doctors.

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease, and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. She’d been denied the medication before, but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention estimated that in 2021 about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. That data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of health care facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives, and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs — such as the number of doctors writing prescriptions, the number of pharmacies used, and drug dosage — to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm or address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it, based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

This prescription-drug data has led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

Bamboo Health said that NarxCare can show providers all of a patient’s scores on one screen, but that these tools should never replace decisions made by physicians.

Some patients say the tools have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and health care fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure, said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources,” including court records, insurance claims, drug monitoring data, property records, and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people — not the algorithms.

Mapp said that “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association.

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board — often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

AI photo

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Allergy drops could be an at-home alternative to shots https://www.popsci.com/health/allergy-drops-sublingual-immunotherapy/ Thu, 17 Aug 2023 01:00:00 +0000 https://www.popsci.com/?p=563287
woman smelling flowers in field.
SLIT drops are formulated using the same liquid extracts in skin-based allergy tests, and research suggests the approach works—and is safe for patients to do at home. DigitalVision via Getty Images

An under-the-tongue treatment is popular in Europe, Canada, and Latin America. Why don’t U.S. allergists offer it?

The post Allergy drops could be an at-home alternative to shots appeared first on Popular Science.

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woman smelling flowers in field.
SLIT drops are formulated using the same liquid extracts in skin-based allergy tests, and research suggests the approach works—and is safe for patients to do at home. DigitalVision via Getty Images

This article was originally published on Undark.

For as long as he can remember, Ken Pressey has had severe allergies to cats. They would trigger hives, runny nose, and watery eyes. Still, like many of the tens of millions of people in the United States who suffer from allergies, Pressey for years did not bother getting treated, or even diagnosed. When cats came near, he just avoided them. 

But that tactic has gotten tougher. During the pandemic, Pressey started dating a woman he’s now engaged to marry—and she has two cats. Being with the cats “was absolute chaos,” said the 30-year-old, who lives in Seattle. “I started having asthma attacks.”

 

Pressey’s primary care physician suggested allergy shots. This century-old approach, a form of immunotherapy, works by exposing the body to small, increasing doses of the culprit substance. Unlike over-the-counter pills and nasal sprays, which only relieve symptoms, shots address the root cause: They help the body build long-term tolerance to the allergens. The treatment is not a cure, but experts say it can bring relief in around 85 percent of patients who try it. And it’s not just a matter of curbing some sneezing. Beyond springtime sniffles, allergies make it hard to concentrate, leading to missed work and school. They can also disrupt sleep, trigger asthma, and contribute to mood disorders.

The procedure for alleviating this misery with allergy shots requires time and diligence. Typically, patients need injections once or twice a week for the first three to six months, then monthly jabs for three to five years. Each office visit also requires a half hour of monitoring after the shot in case of serious reactions, such as wheezing or throat swelling, which are rare but need immediate attention if they occur.

With these scheduling demands, allergy shots were a no-go for Pressey, an engineer with the United States Merchant Marines who often works overseas for months at a time. “I would not be able to keep up,” he said. While looking into alternatives, he recalled a conversation about allergy treatments while stationed in Europe several years earlier, when he heard a coworker say, “We do allergy drops. We don’t do shots. Why would you want to get stabbed by a needle?”

His colleague was referring to a form of sublingual immunotherapy, or SLIT, which builds immune tolerance to allergens administered daily under the tongue. The drops are formulated using the same liquid extracts in skin-based allergy tests, and research suggests the approach works—and is safe for patients to do at home. SLIT drops are a mainstay in Europe, Canada, and Latin America. In the United States, although some medical providers offer the drops off-label, prescribing the treatment remains limited for complex reasons related to regulatory purview and clinic revenue.

 

That means accessing SLIT drops can be tricky, even for highly motivated patients. “I did quite a bit of extensive reading,” Pressey said. The hardest part, he added, was finding a SLIT provider. Although he managed to connect with several doctors who offer the drops, their clinics were far away. Eventually Pressey went to a forum for allergies on Reddit, which led him to try a consult with Curex, one of more than a half dozen virtual health companies that have started selling allergy tests and SLIT directly to consumers.

Some of these companies launched during the pandemic when telehealth was rising and Covid concerns kept some allergy sufferers from going to clinic to get shots. The companies’ services focus on diagnosis and treatment of environmental allergies such as pets, dust, pollens, and grasses.

As more health services move online, patients have greater access to treatments but often sacrifice the continuity of traditional physician-patient relationships. As with other areas of medicine, finding allergy care has become a buyer-beware dilemma: Financial incentives and legal complications prevent SLIT from going mainstream with allergists, and so the challenge of making this treatment available and cost-effective has largely landed in the hands of non-allergist practitioners and business executives.


Allergen immunotherapy traces its roots to a pioneering experiment published in 1911. In that study, a pair of young British researchers rounded up patients and showed that injecting their arms with grass pollen toxins could calm their hay fever—which the researchers measured by dripping pollen extract into the patients’ eyes and noting the extent of burning and itching. With little understanding of the cells and molecules involved, physicians refined this method and, in 1954, confirmed its benefits in a double-blind trial. 

As the shots regimen gained popularity with physicians, the procedure proved quite safe overall, but news of several patient deaths in the early 1980s led some researchers to explore other ways to treat allergies without injections. Their efforts gave rise to sublingual immunotherapy—the liquid drops now offered by direct-to-consumer companies—and, initially, otolaryngologists, or ear, nose, and throat specialists saw potential in what appeared to be a gentler, more convenient allergy treatment.

Otolaryngology is primarily a surgical specialty. But allergies lie at the root of some of the complications that ENT physicians treat, and often present a roadblock. Whenever allergies cropped up as an underlying cause for his patients’ polyps and nasal disease, they “would never go for allergy therapy because, you know, it was always just shots,” said Chris Thompson, an ENT-trained head and neck surgeon in Austin, Texas, who opened his practice in 1997. 

 

Over the next decade, research continued on sublingual immunotherapy. By 2007, there was “growing consensus that specific sublingual immunotherapy (SLIT) does actually work,” according to one review in the Journal of Allergy and Clinical Immunology. In a 2009 position paper, the World Allergy Organization acknowledged SLIT as a viable treatment. Enterprising doctors began offering this type of immunotherapy.

Still, key details about the technique, such as what doses are needed to achieve benefit, seemed murky. “You could literally go to one doctor and get something that was 10,000 times weaker than what you might get from another doctor,” Thompson said. “There was no standardization.” 

Allergists were intrigued by sublingual therapy, but very few at the time offered it in clinic. According to a 2007 survey by the American College of Allergy, Asthma, and Immunology, just 5.9 percent of practicing allergists said they were using SLIT, and by 2011 that figure had only edged up to 11.4 percent. Most respondents cited the lack of FDA-approved products as a barrier.

Nevertheless, interest in sublingual immunotherapy grew in the ENT realm. Professional societies included symposiums about SLIT at their annual meetings and formed subgroups devoted to this new approach. Some otolaryngology group meetings offer courses for physicians to get started with SLIT, Thompson said.

 

Thompson watched the field a while, noting SLIT’s research progress amid overall trends in allergen immunotherapy, which largely persist today. Shots, despite being the bread and butter of U.S. allergy clinics, are vastly underused. Just 2 or 3 percent of newly diagnosed patients who are recommended for the treatment, actually choose it. Relative to the hordes of patients buying over-the-counter Zyrtec, Thompson said, the number who receive immunotherapy “doesn’t even register.”

One way to make a dent, Thompson figured, was to “offer a therapy people will want.” Thompson opened a second practice, Aspire Allergy & Sinus, in 2012, with a focus on sublingual drops. By then, SLIT seemed promising, Thompson said. “We thought, gosh, this is such a great opportunity.” 

A decade later, a similar ambition is fueling direct-to-consumer companies.


There are trade-offs between in-clinic and at-home allergy testing and treatment. When it comes to allergy diagnoses, physicians typically take a detailed clinical history and then use testing, if needed, to confirm the patient’s allergies. Skin testing is the preferred diagnostic among allergists. It has a quick, visual readout—red lumps, or wheals, that form on the patient’s skin 15 to 30 minutes after getting pricked with potential allergens during an office procedure—but it can’t be done at home.

A second type of test checks a patient’s blood for immune proteins called immunoglobulin E (IgE) antibodies. IgE antibodies bind to a specific allergen—say, pollen or peanut—and trigger release of the chemical histamine, which makes people sneeze, itch, swell up, and, occasionally, go into anaphylaxis. Patients can get the blood test at a lab or, increasingly, at home; some online companies sell kits where customers use a provided finger-prick device to apply drops of their blood onto a card, which they can mail to a lab for analysis.

But blood tests can be tricky to interpret, said Robert G. Hamilton, an expert in diagnostic allergy and immunology testing at Johns Hopkins University School of Medicine. A positive result signals the presence of IgE antibody, which “means you’ve become sensitized to the substance,” he said, “but it doesn’t mean you will manifest any allergic symptoms.”

There’s another potential snag. If a patient purchases a home kit and receives results before talking with a physician, confirmation bias can creep in, said Edwin Kim, an allergist-immunologist at the University of North Carolina School of Medicine. If a patient tests positive for dust, for example, the doctor could “ask a thousand questions on dust” until they think they can prove that the patient is “dust-allergic,” he said.

Still, at-home tests and procedures can reach a far broader pool of patients, as it can be difficult to get an in-person appointment with an allergist. At Oregon Health and Science University, “we are booked out through the end of the year,” said allergist-immunologist Shyam Joshi. And at UNC School of Medicine, an academic hub that draws referrals from all over the state and even neighboring states, Kim sees firsthand how patients struggle with their treatment schedule. “We may see them as a great candidate for allergy shots, but you can’t realistically ask people to drive two, three, four hours every week, week after week,” he said.

And allergy shots are not risk-free. While the process goes smoothly for many patients, some develop red, swollen arms after their injection. Occasionally, a shot can trigger an asthma flare-up or a whole-body anaphylactic reaction, said Nikhila Schroeder, an allergist in Huntersville, North Carolina, recalling her own observations about a decade ago when administering shots during her allergy and immunology fellowship. Given all these limitations, “I started to just wonder,” Schroeder said, “Are there any other ways we could do this?”

 

More recently, that same realization hit Gene Kakaulin, a New York City health care entrepreneur. He was commiserating with a friend in 2018 about his allergies to cats, dust, and pollens, and how things had gotten so bad in his teen years that he tried shots. They were “a pain,” said Kakaulin. “I couldn’t stick with them.” 

By contrast, home therapy has lower time demands and less pain and risk—while still desensitizing the immune system by repeated exposures to the allergen. Both approaches produce similar immune changes, though their speed and magnitude, and the types of antibodies involved, can differ. Generally, the immune effects show up faster and stronger with shots, whereas they might take longer with sublingual treatment. It’s hard to compare these changes scientifically—especially since immunotherapy is usually a personalized treatment with dose amounts and escalations tailored to each patient, said Schroeder, whose North Carolina allergy clinic specializes in SLIT.

In studies that have tried to compare the immunotherapy approaches head-to-head, shots seem to do “the same or better” on effectiveness, said Hugh Windom, an allergist in Sarasota, Florida, and on safety, “SLIT always wins.”


Sublingual immunotherapy has been available in the U.S. for decades. SLIT drops, which can treat many different allergens together and are not covered by the Food and Drug Administration, have been offered by at least one allergy clinic since 1970, and by pioneering ENT physicians since the 2010s. In 2014, the FDA approved several tablets that dissolve under the tongue. Three tablets treat grass or ragweed allergies, and a fourth gained approval in 2017 for dust mite allergies.

Still, only about 15 percent of some 2 million allergy immunotherapy patients in the U.S. are using a sublingual version, with the majority on drops, according to market research provided to Undark by Jorge Alderete, who has advised direct-to-consumer allergy companies and other health care startups, and serves on the board of a private equity-backed allergy practice in Houston. An estimated 85 percent of U.S. allergy immunotherapy patients are receiving shots.

One reason is tradition. “We are, of course, wedded to shots because we’ve been doing them for a hundred years,” said Windom.

Another reason relates to versatility. Most allergy patients are allergic to more than one substance, yet allergists tend to prefer FDA-approved products—SLIT tablets—and they only treat a single allergen. Shots, on the other hand, can be tailored to treat many of the patient’s allergens at once. In use for more than a century, allergy shots came to be regulated by the FDA and typically get covered by insurance. SLIT drops can also be customized for multiple allergies, but since the extracts are not FDA-approved for under-the-tongue use and do not have a billing code, patients often must pay out of pocket.

Clinic revenue also plays a role. When an allergist sees a patient and recommends a medication, such as an antihistamine, they charge for a single office visit. Allergy shots bring in more revenue. (Exactly how much revenue can be difficult to estimate, as costs can vary significantly clinic to clinic.) When a patient goes on the shots, three to five years of office treatments at weekly to monthly intervals can amount to dozens of billable visits. Plus, with each visit the clinic charges for mixing the specialized treatment and administering the shot, said Alderete. From a business perspective, he said, immunotherapy is “an annuity.” 

Unlike shots, which are billed as a procedure, SLIT tablets are a prescribed drug. “If you’re going to ask an allergist, hey, do you want to do shots and make money off of it, or prescribe something to Walgreens,” Kim said, it’s understandable that tablets aren’t preferred by allergists in the U.S. Customized SLIT drops are prepared in-house at some clinics, or physicians can send the prescription to a compounding pharmacy.

In the drops form, SLIT does square well with shots on versatility—both can address combinations of allergens with adjustable dosing and escalations—but per-patient profit margins can be higher with shots, said Alderete.

 

This is in part because of doctors’ costs associated with purchasing and preparing the allergen extracts. Though different forms of immunotherapies use the same source material, SLIT preparations can be “significantly more concentrated than even the top doses of allergy shots,” said allergist and immunologist Sakina Bajowala, who offers both treatments at her allergy practice outside of Chicago. In one analysis of immunotherapy regimens for birch allergy, the total amount of allergen administered over the course of a year was 30 times greater with SLIT compared with shots. And office-made SLIT, Bajowala said, can make doctors’ margins even slimmer: “The more extract used, the more costly the drops.”

ENT practices are more willing to offer a less lucrative therapy because, unlike allergists, their revenue mostly comes from surgeries, so SLIT is “a bit of an ancillary service,” said Thompson.

But on the whole, SLIT drops remain far from mainstream, even as interest in this mode of treatment grows.


After hearing about his friend’s needle-free therapy—SLIT drops—Kakaulin made a round of calls to practices in New York so he could try SLIT himself. His symptoms improved “within a few months,” which helped him sleep and exercise better, he said. To this day, the drops remain a part of Kakaulin’s morning routine—“two minutes under the tongue right after brushing teeth when I shave.” 

Along the way, he co-founded Curex, one of several online allergy companies that got off the ground during the pandemic as telemedicine soared. While just 1 percent of allergy appointments took place virtually before the pandemic, that figure jumped to 54 percent one month into lockdown. Across medicine, telehealth shot up 78-fold between February 2020 and April 2020, according to an analysis, from the consulting firm McKinsey, and after a year remained 38 times higher than pre-pandemic.

Meanwhile, brick-and-mortar clinics took a hit. “A lot of allergy offices closed because of Covid concerns, and then people who were supposed to get shots were left out in the cold,” said Kim.

Direct-to-consumer allergy companies capitalized on this perfect storm, luring customers with glowing testimonials, free quizzes, and heaps of online advertising. Their social media ads showcase sublingual drops as a “convenient alternative to allergy shots” with “no trips to the doctor’s office or prickly needles.”

 

Some of these companies also offer allergy testing. Curex can send a phlebotomist to administer blood tests to patients with eligible zip codes. Wyndly, a company headquartered in Lakewood, Colorado, ships a $249 test kit to the customer’s home. New York City-based Nectar also sells home tests and lets patients upload results of previous allergy testing. Based on test results and a medical consult, the companies sell formulated sublingual drops on subscription plans, some at $99 per month or less. “We think there are tens of millions of Americans who could benefit,” said Kakaulin, who had helped start a prescription savings company before launching Curex in 2020.

To reach those millions of potential customers, companies that sell allergy drops face similar financial challenges as allergy practices. The average SLIT patient “produces 70 or 80 percent less revenue than an allergy shot patient,” Kakaulin said. So instead of trying to maximize per-patient profit, Curex is trying to “maximize some of our efficiencies and provide everyday low prices,” he said.

Toward this end, nationwide direct-to-consumer companies, as well as large multi-site allergy practices, can negotiate lower pricing on allergen extracts and other supplies because they order huge volumes. Small practices often do not get these discounts and thus have higher backend costs if they choose to offer off-label SLIT.

Amid these financial considerations, there’s also a mindset difference between serving patients and winning customers. With a business model that relies on “one thing,” Bajowala said, it’s in a direct-to-consumer company’s interest to create ads that say, “well, the thing we’re offering is the best, so why would you even want to consider the other thing?”

Some allergists worry that direct-to-consumer companies hasten a broader trend: the decline of the practitioner-patient relationship. When patients begin a new treatment, they “need to know when is it going to start working, how to monitor for side effects, and if there’s a problem, who are you going to go to?” said Anne Maitland, an allergist-immunologist at Icahn School of Medicine at Mount Sinai in New York City and the director of allergy and immunology at the Metrodora Institute in Salt Lake City, Utah. 

At direct-to-consumer companies, details about what’s in the treatment and who’s providing the medical care are also somewhat of a black box. Pressey, the Merchant Marine with the cat allergy, said that if he were to request a consult at Curex, for instance, it would not be with the provider who did his intake. “That person doesn’t work there anymore,” he said. And if he ever wanted to stop his subscription and continue SLIT treatment elsewhere, Curex does not “give you the exact mixture that you’re getting treated for,” Pressey said.

As for staffing, Nectar relies heavily on primary care physicians with training in allergy immunotherapy, but a public relations spokesperson denied a request to interview one of these providers. Regarding the number of doctors in the Curex network, Kakaulin declined to answer. “I’d rather not talk about specifics of the business,” he said. “We’d prefer to have certain information kind of private.”

While the approach lacks transparency, patients often can’t access information in traditional health care settings, either. In a health care system that favors standardized protocols, insurance reimbursements and clinic business priorities may compel physicians to recommend certain treatments, making it hard for patients to learn about the full spectrum of options, said Schroeder, whose clinic offers SLIT using a direct-care model, where patients pay the provider directly rather than using traditional fee-for-service insurance. 

In fact, the allergy clinic might be one of the hardest places to get clear information about treatment options. That’s in part because of a lawsuit from almost a decade ago. In 2014, the American Academy of Allergy, Asthma & Immunology (AAAAI), American College of Allergy, Asthma & Immunology (ACAAI), and several other allergy groups were sued by United Allergy Services, a company that helps primary care physicians and other non-specialists diagnose and treat allergies.

The company alleged that allergists who decried UAS practices were restricting the market and limiting patient access to allergen immunotherapy. As part of a settlement, the allergy groups issued a policy statement requiring members to minimize litigation risk by complying with antitrust laws. As Matt Bell, an allergist in Fayetteville, Arkansas, explained it, the lawsuit is “why we are hesitant to talk.” The settlement terms “basically stated that AAAAI had to keep their mouths shut,” said David Stukus, an allergist at Nationwide Children’s Hospital in Columbus, Ohio, who declined to speak about specific companies or services.

 

And depending on where and how a patient finds SLIT, their experiences can vary widely. With rising demand for allergy care and limited allergist availability, patients can get allergy treatment from many sources besides their local allergist — including ENT practices, primary care doctors, pediatricians, urgent care, emergency rooms, naturopathic doctors, and direct-to-consumer companies. “If you do SLIT at different places, it won’t necessarily be the same. The people may have different levels of expertise,” said Schroeder, who learned the ins and outs of sublingual therapy at Allergy Associates of La Crosse, a Wisconsin clinic that has offered this treatment for environmental and food allergies since 1970. Nevertheless, she said, there’s a role for all these various avenues as long as patients understand the complexities and “know what they’re pursuing.”

So far, the direct-to-consumer drops seem to be working well for Pressey. Before starting treatment in 2021, he struggled with frequent allergy-induced asthma attacks. “I couldn’t make it 24 hours with a cat in the house,” he said in a recent interview. Now “it’s about two and half weeks before I even remember that I have asthma.” 

Pressey still has questions about the therapy and about Curex—like how long the benefits will last and whether the company will survive. Even when scouring Reddit in spring 2021, he could not find answers to these questions. Nevertheless, “I’m a firm believer in new technology,” he said. “You know what, if no one tries it, then no one will ever get the answers.”

This article was originally published on Undark. Read the original article.

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Extreme heat could be a threat to contraception https://www.popsci.com/health/extreme-heat-birth-control-pregnancy/ Wed, 16 Aug 2023 01:00:00 +0000 https://www.popsci.com/?p=563112
pregnancy test in hands
Pregnancy tests, condoms, and emergency contraception pills are all vulnerable to damage in extreme temperatures, which is particularly concerning for individuals in states with abortion bans. Deposit Photos

Many states with abortion bans are experiencing broiling summers—and the heat could damage supplies such as emergency contraception and pregnancy tests.

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pregnancy test in hands
Pregnancy tests, condoms, and emergency contraception pills are all vulnerable to damage in extreme temperatures, which is particularly concerning for individuals in states with abortion bans. Deposit Photos

Originally published by The 19th. We’re answering the “how” and “why” of health and abortion news. Sign up for our daily newsletter.

Extreme heat has already made pregnancy more dangerous. Now, it is also complicating efforts to control when and how someone becomes pregnant: Record heat waves across the country could threaten access to effective pregnancy tests, condoms and emergency contraception pills. 

All of these items can sustain serious damage in extreme heat, rendering them ineffective when used. And all have become critical resources for people living in states with abortion bans and who are trying to avoid pregnancy. In those states, few options exist to terminate an unintended pregnancy other than acquiring abortion pills online or traveling out of state for care.

Many states that have banned abortion are experiencing broiling summers, including Texas, Louisiana, parts of Mississippi and Arkansas. Florida—where abortion is banned after 15 weeks of pregnancy and a six-week ban could take effect later this year—has also recorded unusually high temperatures. 

“People aren’t thinking about the effects of extremely hot heat for all kinds of medical care,” said Rachel Rebouché, dean at the Temple University School of Law, who studies reproductive health law. “And, specific to reproductive health care, people aren’t thinking about condoms and contraception and reproductive health as essential health care.”

In some states that restrict or ban abortion, abortion funds—which typically aid people in paying for the procedure—have put more emphasis on distributing supplies to prevent pregnancy and to detect it early, even while noting that even the most effective contraception isn’t foolproof. Almost all of the supplies they ship are heat-sensitive.

The Yellowhammer Fund, which serves people mostly in Alabama and Mississippi, mails emergency contraception to people in those two states as well as in parts of Florida. Jane’s Due Process, a Texas-based organization, has for the past three years given people kits including emergency contraception, pregnancy tests and condoms. The Lilith Fund, an abortion fund in Texas, recently began distributing “post-abortion” kits for people traveling out of state for care, which include pregnancy tests, condoms and thermometers. 

Pregnancy tests generally should be stored at a temperature between 36 and 86 degrees Fahrenheit. Emergency contraception pills should be kept between 68 and 77 degrees, per the Food and Drug Administration, though they can be transported in temperatures ranging between 59 and 86 degrees. For condoms, the World Health Organization recommends an average shipment temperature no warmer than 86 degrees, noting that peak temperatures shouldn’t exceed 122 degrees and that condoms could be damaged if they are stored at above 104 degrees for an extended period of time. 

Extreme heat has already complicated efforts to disseminate contraceptive supplies. Last month, staff from the Lilith Fund reported heat damage to about $3,500 worth of pregnancy tests, thermometers and condoms, the result of a temporary air-conditioning outage at a storage facility in San Antonio. The organization was able to raise money from supporters to replace those items, but will be factoring heat risk in future budgets.

“It’s on our radar, and it’s on the radar of our partners as well,” said Cristina Parker, the fund’s communications director. “This definitely has an impact on our budget, no doubt.”

Other organizations haven’t experienced similar damage. But organizers and health scholars indicated concern that the unusually warm summer—with temperatures across much of the South consistently surpassing 100 degrees Fahrenheit at a higher frequency than usual—will undercut people’s ability to access heat-sensitive reproductive health supplies.

“One thing we’ve always stressed is do not keep kits in your car, especially in Texas heat,” said Graci D’Amore, who coordinates the distribution of reproductive health kits for Jane’s Due Process. “It’s 120 degrees in the car, and Plan B needs to be kept at below 80 degrees for it to maintain efficacy.”

Jane’s Due Process stores its supplies in an air-conditioned office building. But the fear of losing power is more pressing than it was even a few years ago, before a winter snowstorm—also unusual for the state—caused a massive power outage.

“The fear and threat of the [power] grid failing—I think it’s on everyone’s mind,” D’Amore said. 

Many organizations, including the Yellowhammer Fund and the Texas family planning provider Every Body Texas, distribute emergency contraception through the mail. But even if medications are stored in a climate-controlled atmosphere, they risk exposure to heat while waiting in someone’s mailbox, at their doorstep or in a delivery vehicle. In those cases, there is little health or reproductive rights organizations can do other than encourage people to bring mail in as quickly as possible.

“When I bring in packages, even when they have not been outside for very long, the contents have been hot to the touch,” said Elizabeth Sepper, a health law professor at the University of Texas at Austin. “There’s no way to control what happens once it leaves your hand.”

The heat burden, Sepper and others noted, doesn’t fall equally. People who don’t have access to regular air-conditioning in their homes or cars are more likely to be exposed to extreme heat and to potentially risk damage to family planning and reproductive health supplies. Those who seek abortions and who have to travel out of state, which can mean several hours or even days’ worth of driving, could also suffer more. 

“Even people who have cars with functioning air conditioners will find their car engines or air-conditioning can struggle in long travel in this heat,” Sepper said. “If you’re in a car that doesn’t have functioning air-conditioning or that might struggle to make long distances in the heat—we will see for poorer people, the travel out of state will become even more onerous than it already is.”

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Why medical engineers tattooed a single cell with gold https://www.popsci.com/technology/gold-cell-tattoo/ Wed, 09 Aug 2023 17:15:05 +0000 https://www.popsci.com/?p=562133
Microscopic image of individual cell tattooed with gold array
The tattooing can function like a barcode to track cellular movements. KAM SANG KWOK AND SOO JIN CHOI, GRACIAS LAB/JOHNS HOPKINS UNIVERSITY

The tiny tattoos could one day help monitor health at the cellular level.

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Microscopic image of individual cell tattooed with gold array
The tattooing can function like a barcode to track cellular movements. KAM SANG KWOK AND SOO JIN CHOI, GRACIAS LAB/JOHNS HOPKINS UNIVERSITY

An estimated one-in-four Americans have a tattoo, but it’s safe to say pretty much all of them are visible to the naked eye in some shape or form. But thanks to new breakthroughs in nanoengineering, tattooing can now be done at the cellular level—not for artistic expression, per se, but for a myriad of potential medical benefits.

According to research published this month via Nano Letters, engineers at Johns Hopkins University have developed a miniscule tattooing procedure capable of adhering to individual, live cells. Instead of ink, however, experts attached gold arrays to fibroblasts, cells that sustain body tissue. The team, led by professor of chemical and biomolecular engineering David Gracias, then treated the arrays with molecular glues before transferring them directly onto cells via a dissolvable hydrogel laminate. According to JHU on August 7, the final results are akin to scannable QR codes and barcodes.

[Related: Tattoos are permanent, but the science behind them just shifted.]

“We’re talking about putting something like an electronic tattoo on a living object tens of times smaller than the head of a pin,” David Gracias said via the statement. “It’s the first step toward attaching sensors and electronics on live cells.”

What makes the new technique so particularly impressive is that “tattooing” the cells does not adversely affect their health or lifespan. According to researchers, attaching optical and electronic sensors to individual cells has previously caused been tricky, but methods like the tattoos could hopefully allow such technology to be one day deployed in real-world medical settings.

Gold nanowire array on a rat brain
Gold nanowire array on a rat brain. Credit: KAM SANG KWOK AND SOO JIN CHOI, GRACIAS LAB/JOHNS HOPKINS UNIVERSITY

Nanoscale cellular tattooing could open up entirely new avenues of health monitoring for medical experts. As Gracias explains, doctors could hypothetically track the health of isolated cells, thereby potentially identifying, diagnosing, and treating diseases far earlier than is currently possible.

“If you imagine where this is all going in the future, we would like to have sensors to remotely monitor and control the state of individual cells and the environment surrounding those cells in real time,” said Gracias.

The current tattoo tech has a few limitations at the moment—namely, that its lifespan maxes out at around 16 hours. The method is also only compatible at the moment with certain cells such as fibroblasts. Going forward, the team intends to increase the nanoarrays’ durability, longevity, and complexity, while also opening up the technique to a host of other cell varieties.

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FDA approves first postpartum depression pill https://www.popsci.com/health/fda-postpartum-depression-pill/ Mon, 07 Aug 2023 13:00:00 +0000 https://www.popsci.com/?p=561544
A mother holds a hand of a tiny newborn baby. Postpartum depression is a leading cause of maternal mortality.
Postpartum depression is a leading cause of maternal mortality. Deposit Photos

The medication is a first-of-its-kind treatment in the United States for a condition that affects thousands of new mothers every year.

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A mother holds a hand of a tiny newborn baby. Postpartum depression is a leading cause of maternal mortality.
Postpartum depression is a leading cause of maternal mortality. Deposit Photos

On August 4, the United States Food and Drug Administration (FDA) approved zuranolone to treat postpartum depression. The medication is now the first FDA-approved oral pill available in the US to treat postpartum depression. The serious mental illness can develop in roughly 1 in 7 new mothers following childbirth and is one of the leading causes of maternal mortality. 

[Related: The important difference between postpartum psychosis and postpartum depression.]

The first-of-its-kind treatment will be sold under the brand named Zurzuvae and is a once-daily pill taken over 14 days. 

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,”  director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research Tiffany R. Farchione said in a statement. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

Some of the depression symptoms common in new mothers include changes in appetite and sleep. However clinicians say the more severe symptoms that might signal postpartum depression include feelings of sadness, hopelessness, guilt, or worthlessness in addition to trouble bonding with the baby. Severe symptoms can include suicidal thoughts. 

Postpartum depression often ends on its own within a few weeks, but it can continue for months or even years. The standard course of treatment includes talk therapy and/or antidepressants, which do not help everyone and can take weeks to work. 

The FDA’s pill approval is based on two company studies that demonstrated that new moms who took Zurzuvae had fewer signs of depression over a four- to six-week period, compared with those who did not take the medication. The benefits were measured by a psychiatric test and appeared within only three days for many of the patients in the trial.

As part of the approval, the FDA added a warning to Zurzuvae’s labeling indicating that it can impact the ability to drive, and patients may be able to assess how impaired they are by the drug. The FDA says patients should not should not drive or operate heavy machinery for at least 12 hours after taking the medication. Zurzuvae’s most common side effects include dizziness, drowsiness, fatigue, diarrhea, the common cold, and urinary tract infection. The FDA also said that it could cause suicidal thoughts and behavior, may also cause harm to a fetus, and that patients should use effective contraception while taking the drug and for a week after stopping. 

[Related: A link to depression might be in your gut bacteria.]

Zurzuvae is manufactured by Sage Therapeutics, which has a similar infused medication called Zulresso that’s given intravenously over three days in a medical facility. Zulresso was approved by the FDA in 2019, but it is not widely used largely due to the logistics of administering it and the roughly $34,000 cost. 

In February, the FDA accepted an application from Biogen and Sage Therapeutics for the approval of zuranolone and granted a priority review. The drug is part of an emerging class of medications from Sage called neurosteroids. These medications stimulate a different pathway in the brain than older antidepressants which target a chemical linked to emotions and mood called serotonin.

Kimberly Yonkers, a Yale University School of Medicine psychiatrist specializing in postpartum depression, told the Associated Press that Zurzuvae effect is “strong” and the medication will likely be prescribed in those who haven’t responded to treatment with antidepressants. However, she did say the FDA should have required more follow-up data on how patients fared after additional months of treatment.

“The problem is we don’t know what happens after 45 days,” said Yonkers, who was not involved in the study. “It could be that people are well or it could be that they relapse.”

All women should be screened for postpartum depression during the early days of a pregnancy, and a first step should be contacting an obstetrician or midwife for help if not screened. Additional resources for postpartum depression include the national maternal mental health hotline (1-833-852-6262) and Postpartum Support International.

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RSV antibody shot will be available for babies in the US this fall https://www.popsci.com/health/rsv-antibody-shot-cdc-advisory-panel/ Fri, 04 Aug 2023 15:00:00 +0000 https://www.popsci.com/?p=561216
A newborn baby's hand with a hospital bracelet around his or her wrist. RSV sends about 58,000 children under five to the hospital, and kills 100 to 300 infants every year in the United States.
RSV sends about 58,000 children under five to the hospital, and kills 100 to 300 infants every year in the United States. Deposit Photos

A panel of independent experts voted unanimously to recommend the treatment to protect infants from the lung-infecting virus.

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A newborn baby's hand with a hospital bracelet around his or her wrist. RSV sends about 58,000 children under five to the hospital, and kills 100 to 300 infants every year in the United States.
RSV sends about 58,000 children under five to the hospital, and kills 100 to 300 infants every year in the United States. Deposit Photos

The Centers for Disease Control and Prevention (CDC) is recommending that all infants under eight months old should get a new antibody shot aimed to protect the body against severe cases of respiratory syncytial virus (RSV). The agency’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on August 3 to recommend the injection to protect babies beginning this fall. 

[Related: FDA approves long-acting medication to protect babies from RSV.]

In July, the Food and Drug Administration approved nirsevimab, which is the first long-acting medication to protect babies and toddlers from RSV. The lung-attacking virus sends about 58,000 children under five to the hospital, and kills 100 to 300 infants every year in the United States. RSV season typically lasts from November through March.

CDC director Mandy Cohen signed off on the recommendation and it will be added to the CDC’s childhood immunization schedule. ACIP also unanimously recommended that certain infants between the ages of eight to 19 months should receive a second dose of nirsevimab to help them stay healthy during their second RSV season if they have any underlying health issues that put them at a higher risk of hospitalization. 

“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” Cohen said in a statement. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”

In a second unanimous vote, ACIP also recommended that certain infants ages eight to 19 months get a second dose of nirsevimab to help them through their second RSV season, if they have underlying health issues that put them at higher risk for hospitalization.

Vaccines for older adults were FDA approved in May, but there are currently no vaccines for babies. The FDA is expected to make a decision on an RSV vaccine for pregnant people, with the goal of passing along protection on to newborns, later in August.

Importantly, nirsevimab is not a vaccine for RSV. It is a lab-made antibody for babies that helps their immune systems fight off the virus and is also the first first form of passive immunization added to the routine childhood immunization schedule. Passive immunizations do not require the body to manufacture antibodies against pathogens the way that vaccines do. Instead, they sent protective antibodies to attack the virus.

[Related: How our pandemic toolkit fought the many viruses of 2022.]

ACIP voted to add the antibody shot to the federally funded Vaccines for Children Program. This program provides free immunizations to children who may have difficulty accessing them. 

Nirsevimab was developed by AstraZeneca and Sanofi and is expected to be ready for the fall RSV season and will be sold under the brand name Beyfortus. Sanofi reportedly said that if this shot is recommended for all infants, it will cost $495 per dose for private payers and $395 through Vaccines for Children. 

The cost of the drug could make it difficult for some doctors to stock up on nirsevimab and complicate billing. However, getting this recommendation from ACIP means that families will not pay an out-of-pocket cost due to the Affordable Care Act. It may take up to 18 months for this coverage to kick-in, as insurers have a year to add implement coverage of new treatments that will then take effect in the new plan year. 

According to CBS News, director of the National Center for Immunization and Respiratory Diseases José Romero closed the meeting by saying, “I would be remiss if I didn’t say that today is a historic event. I think that we will look back on this, in a short period of time, and see what a major impact this vote has had on the health and wellbeing of children in the United States. I think that this will mark one of the major accomplishments of the ACIP.”

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Glowing dye lets us peek inside growing bones and teeth https://www.popsci.com/science/teeth-bones-growing-image/ Wed, 02 Aug 2023 18:30:00 +0000 https://www.popsci.com/?p=560795
Fluorescent dye shows the growth of teeth and bones.
A new tool tracks hard tissue growth like teeth and bones in many species. Gonzalez Lopez et al. Sci. Adv. 2023

For the first time, biologists have precisely tracked the development of hard biological structures.

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Fluorescent dye shows the growth of teeth and bones.
A new tool tracks hard tissue growth like teeth and bones in many species. Gonzalez Lopez et al. Sci. Adv. 2023

Your body contains the stuff of rocks: the calcium-based minerals in bones and teeth. In a process called biomineralization, you produce these materials that harden and stiffen as they grow. So do the bodies of other bony, toothed animals. It’s in shells, too: Iridescent mother-of-pearl forms via biomineralization.

But, historically, biologists struggled to observe how this process worked. Now, scientists have been able to observe it in vivid 3D. Bones and tEEth Spatio-Temporal growth monitoring (BEE-ST), as its creators have named their technique, involves adding dye to nascent bones or budding teeth, then watching the color spread as their host components grow.

BEE-ST’s creators published their work in the journal Science Advances today. If its authors are correct, then this work could be a boon for people who aren’t just studying how bones and teeth grow, but people who want to control that growth themselves.

“Currently, there are no available tools for precise monitoring and measuring the pace of tooth growth in space and time,” says Jan Křivánek, a developmental biologist at Masaryk University in Brno, Czechia, and one of the paper’s authors. BEE-ST, they hope, may change that.

[Related: This new synthetic tooth enamel is even harder than the real thing]

A few methods can accomplish parts of that goal. Today, scientists and medics can rely on a technique called micro-computed tomography, in which they scan an object with X-rays from multiple angles, then stitch the scans together into a 3D image. While this does give observers a 3D perspective, it also only gives a snapshot—moments in time, rather than a coherent sequence of development.

Another potential option is dye. Bone-watchers have known for decades that dye and substances like it can bind with the calcium in these organs. But this is far from a perfect option to watch how calcium-based structures grow. For one, to see into a bone, you typically have to remove the calcium from your sample, which removes the dye. You can get around this by taking a slice of the tooth or bone, but that only gives you a 2D shadow of the larger 3D picture.

Křivánek and his colleagues wanted to see how mouse teeth grew, but they also wanted a more sophisticated way of seeing calcium. So, they decided to adapt the dye method. Fortunately, in the last several years, researchers had developed techniques to see into a tooth without removing the calcium. They could insert dye into a growing tooth or bone and take 3D images of it over time. Every few days, the researchers added batches of new dye to lab mice. The result, when the scientists later placed the teeth under a microscope, was a sequence of stripes: each one marking a different injection.

[Related: We finally know why we grow wisdom teeth as adults]

In the process, they realized that their technique could be used for more than just mouse teeth. They next showed it could work in a mouse’s bones. Then they expanded from mice to representatives of other provinces in the animal kingdom, administering dye to a menagerie of vertebrates: chameleons (reptiles), junglefowl (birds), frogs (amphibians), and zebrafish (fish).

All of this took Křivánek and colleagues several years, but in the end, they think they have created a reliable process for watching how teeth and bones grow. But that doesn’t mean it only serves this purpose. “We strongly believe it will be further tuned for other applications,” Křivánek says.

One of them is a field called tissue engineering, the science and craft of manipulating the tissues of the human body. A “tissue” can be anything from skin to muscle to internal organs—to stronger materials like the hard, tough matter found in bone and tissue. With tools such as stem cells, scientists can strengthen tissue, improve it, or even try to replicate it from scratch. This technology can help heal cracked bones or regenerate missing teeth.

But, in order to engineer anything, would-be bonesmiths first need to understand how their materials behave as they grow. That, Křivánek thinks, is where something like their method could enter the picture. “We basically opened doors,” he says. “Let’s see how the scientific community will use it.”

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First-of-its-kind AI brain implant surgery helped a man regain feeling in his hand https://www.popsci.com/technology/double-neural-bypass-surgery-ai/ Tue, 01 Aug 2023 20:00:00 +0000 https://www.popsci.com/?p=560334
Patient with brain microchip implants atop head
Five tiny microchips implanted in Keith Thomas' brain are helping him regain mobility and sensation. Northwell Health

Just four months after the groundbreaking procedure, the patient with quadriplegia was able to feel the touch of his sister's hand.

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Patient with brain microchip implants atop head
Five tiny microchips implanted in Keith Thomas' brain are helping him regain mobility and sensation. Northwell Health

On July 18, 2020, a diving accident injured a man’s C4 and C5 vertebrae, resulting in a total loss of movement and sensation below his chest. After participating in a first-of-its-kind clinical trial, however, Keith Thomas is now regaining sensations and movement in his hands just months after receiving AI-enabled microchip brain implants. What’s more, he is experiencing lasting improvements to his wrist and arm functions outside of the lab setting, even after turning off the devices.

“This is the first time the brain, body and spinal cord have been linked together electronically in a paralyzed human to restore lasting movement and sensation,” Chad Bouton, a professor in the Institute of Bioelectronic Medicine at the Feinstein Institutes, the developer of the tech, and the trial’s principal investigator said in a statement in July. “When the study participant thinks about moving his arm or hand, we ‘supercharge’ his spinal cord and stimulate his brain and muscles to help rebuild connections, provide sensory feedback, and promote recovery.”

[Related: Neuralink human brain-computer implant trials finally get FDA approval.]

To pull off the potentially revolutionary rehabilitation, Bouton’s team at Northwell Health in New York first spent months mapping Thomas’ brain via functional MRIs, eventually locating the exact regions responsible for his arms’ movements, as well as his hands’ sensation of touch. From there, neurosurgeons conducted a 15-hour operation—some of which occurred while Thomas was awake—to properly place two chips to restart movement, and three more in the area controlling touch and feeling in his fingers.

The intense procedure also included the installation of external ports atop Thomas’ head, which researchers connected to an AI program used to interpret his brain activity into physical actions—a system known as thought-driven therapy. When the AI receives his mind’s inputs, it then translates them into signals received by non-invasive electrodes positioned over both his spine and forearm muscles to stimulate movement. Additional sensors placed atop his fingertips and palms additionally transmit pressure and touch data to the region of his brain designated for sensation.

Paralyzed man's hand holding his sister's hand after neurosurgery implant.
Credit: Northwell Health

After only four months of this therapy, Thomas regained enough sensation in his fingers and palm to hold his sister’s hand, as well as freely move his arms at more than double their strength prior to the trial. The team has even noted some astounding natural recovery, which researchers say could permanently reduce some of his spinal damage’s effects, with or without the microchip system in use.

The new technology’s implications are already extremely promising, says Northwell Health’s team, and show that it is possible to reforge the brain’s neural pathways without the use of pharmaceuticals. According to Thomas, his progress alone has already been life changing.

“There was a time that I didn’t know if I was even going to live, or if I wanted to, frankly. And now, I can feel the touch of someone holding my hand. It’s overwhelming,” Thomas said on July 28. “… If this can help someone even more than it’s helped me somewhere down the line, it’s all worth it.”

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Henrietta Lacks’ stolen cells changed medicine—and her family is finally getting compensated https://www.popsci.com/health/henrietta-lacks-settlement-hela-cells/ Tue, 01 Aug 2023 16:30:00 +0000 https://www.popsci.com/?p=560352
The general atmosphere at HBO's The HeLa Project Exhibit For the film adaptation of "The Immortal Life of Henrietta Lacks" on April 6, 2017 in New York City. Two women stand by a portrait of Lacks wearing a red dress.
The general atmosphere at HBO's The HeLa Project Exhibit For the film adaptation of "The Immortal Life of Henrietta Lacks" on April 6, 2017 in New York City. Nicholas Hunt/Getty Images for HBO

Lacks' 'HeLa cells' were crucial to the development of cancer treatments, COVID-19 vaccines, and more.

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The general atmosphere at HBO's The HeLa Project Exhibit For the film adaptation of "The Immortal Life of Henrietta Lacks" on April 6, 2017 in New York City. Two women stand by a portrait of Lacks wearing a red dress.
The general atmosphere at HBO's The HeLa Project Exhibit For the film adaptation of "The Immortal Life of Henrietta Lacks" on April 6, 2017 in New York City. Nicholas Hunt/Getty Images for HBO

The living relatives of Henrietta Lacks have reached a settlement with the biotechnology company that took her cervical cells without her knowledge over 70 years ago. Lacks’ descendants sued Massachusetts-based Thermo Fisher Scientific in 2021, accusing the leaders of profiting off of a racist medical system.

[Related: Five Reasons Henrietta Lacks is the Most Important Woman in Medical History.]

“The exploitation of Henrietta Lacks represents the unfortunately common struggle experienced by Black people throughout history,” the complaint from the family reads. “Too often, the history of medical experimentation in the United States has been the history of medical racism.”

In 1951, tissue was taken from a tumor on Lacks’ cervix when she sought treatment for cervical cancer at Johns Hopkins. Scientists quickly discovered that these “HeLa cells” had some incredibly special properties. They survived and thrived in laboratories, instead of quickly dying after being taken out of the body. The HeLa cell line has been reproduced numerous times ever since, and has become a cornerstone of modern medicine. Lacks’ cells have become a baseline for medicine and enabled numerous medical and scientific innovations including the development of genetic mapping, cancer treatments, HIV/AIDS treatments, and the polio and COVID-19 vaccines

Despite Lacks’ outsized impact, her family had never been compensated. Currently, the terms of the settlement are confidential. Prominent civil rights attorney Ben Crump represented the Lack family and said that both parties are “pleased” the matter was resolved outside of court, according to the Associated Press. The announcement also came on August 1, which would have been Lacks’ 103rd birthday.

“I can think of no better present… than to give her family some measure of respect for Henrietta Lacks, some measure of dignity for Henrietta Lacks, and most of all some measure of justice for Henrietta Lacks,” Crump said at a press conference on Tuesday morning, according to CBS News. The family present at the press conference included Lacks’ only living son and some of her grandchildren.

[Related: Racism is undeniably a public health issue.]

Lacks was a tobacco farmer from southern Virginia and was raising five children when the tumor on her cervix was discovered. She was only 31 when she died and was buried in an unmarked grave.

In a statement, Johns Hopkins Medicine officials said they reviewed all of the university’s interactions with Lacks and her family after the publication of Rebecca Skloot’s bestselling book, The Immortal Life of Henrietta Lacks in 2010. While acknowledging an ethical responsibility, Johns Hopkins said the medical system “has never sold or profited from the discovery or distribution of HeLa cells and does not own the rights to the HeLa cell line.”

On July 25, Senators Chris Van Hollen (D-Maryland) and Ben Cardin (D-Maryland) both introduced a bill to posthumously award Lacks the Congressional Gold Medal. “Henrietta Lacks changed the course of modern medicine,” Van Hollen said in a statement announcing the bill. “It is long past time that we recognize her life-saving contributions to the world.”

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Why studying horses could help humans stay healthy, too https://www.popsci.com/health/horses-health-humans-diabetes-obesity/ Tue, 01 Aug 2023 01:00:00 +0000 https://www.popsci.com/?p=560196
Side view of woman's hand feeding horseback on sunny day
Like people, horses with endocrine disorders are also prone to orthopedic diseases. Getty Images

Research on diagnostics and treatments for metabolic conditions could provide health benefits to both species.

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Side view of woman's hand feeding horseback on sunny day
Like people, horses with endocrine disorders are also prone to orthopedic diseases. Getty Images

This article is republished from The Conversation.

As a veterinary science researcher, equine surgeon and sports medicine and rehabilitation specialist, I’ve seen firsthand the similarities between horses and humans.

Both horses and people with endocrine disorders like Type 2 diabetes can suffer multiple types of musculoskeletal disorders. For example, horses with pituitary pars intermedia dysfunction—similar to Cushing’s disease in people—suffer from tendon and ligament degeneration. Horses can also experience muscle loss, which can cause joint instability. That, and the chronic low-grade inflammation associated with endocrine disorders, can contribute to osteoarthritis.

There’s a principle in medicine called One Health, which says that animals, humans and the environment are inextricably connected—for one to be healthy, all must be healthy. It also means that we can learn a lot about our own health by studying the health of animals, and vice versa, including the many parallels in endocrine disorders between humans and horses.

Human and horse endocrine systems

Your endocrine system produces hormones that support many of your body’s basic functions, including growth and development, metabolism, sleep and more. Your hormones also play a role in the health of your bones, tendons and ligaments. Some endocrine disorders change how your body produces and releases hormones and can lead to osteoporosis, arthritis, ligament injury and other orthopedic diseases.

Humans aren’t the only species affected by this dynamic—horses are, too. In fact, approximately 20 percent of horses and over 34 percent of people in the U.S. are affected by endocrine disorders such as metabolic syndrome. These disorders are often accompanied by obesity.

For both species, the degree to which endocrine disorders are connected to obesity and its associated negative health effects is complex. As mammals, horses and people share similar anatomy and endocrine physiology, and researchers have noted their parallel genetic links between obesity and metabolic disease.

Like people, obese horses with endocrine disorders often develop low-grade inflammation. Inflammation is a normal response to injuries and sickness. But chronic, low-grade inflammation can have long-term negative effects on the body. For example, low-grade inflammation is associated with metabolic osteoarthritis in people, and my laboratory is studying this possible link in horses.

In people, childhood obesity, which is related to maternal obesity, is associated with a type of joint disease called osteochondrosis. Foals born from obese mares are also predisposed to this same type of joint disease.

Research to note

Because of the similarities between people and horses, research on diagnostics and treatments for metabolic conditions could provide health benefits to both species.

For example, a class of drug called glucagonlike peptide-1 agonists, which includes such brands as Trulicity (dulaglutide) and Ozempic (semaglutide), is commonly used to treat metabolic syndrome and Type II diabetes in people. This class of medication is also effective in treating these conditions in horses, similarly slowing down how quickly food empties the stomach and blunting glucose release into the bloodstream.

Another class of drugs called sodium-glucose cotransporter protein-2 inhibitors, which include such treatments as Jardiance (empagliflozin) and Farxiga (dapagliflozin), are used to treat Type 2 diabetes in people and a similar condition in horses. These drugs alter the kidneys’ ability to absorb sugar from urine such that the body eliminates some of the glucose it would normally absorb. This greatly reduces blood insulin spikes, which can help prevent obesity, metabolic syndrome and cardiovascular disease in both horses and people.

Some dietary supplements, such as resveratrol, especially when used in combination with an amino acid called leucine, also help with weight loss, mobility and insulin sensitivity in people and horses. Lowering blood insulin concentrations can also prevent horses from developing laminitis, a disease that inflames tissues in hooves that can necessitate euthanasia because of incurable pain.

Expanding precision medicine

I find one of the most exciting avenues of research in both animals and people to be the expansion of precision medicine. Instead of the standard one-size-fits-all protocol, precision medicine uses information from a person’s genes, environment and medical history to create a customized treatment plan. For example, precision medicine is often applied in oncology when doctors gather genetic information about the patient’s tumor to inform which treatments might work best for them.

In horses, precision medicine currently focuses on DNA-based diagnostic tests to inform exercise regimens, treatment and breeding decisions. Recent work with horses also suggests that measuring the heritability of certain metabolic traits could be used to screen for metabolic syndrome in the future.

Within precision medicine, doctors aim to get a full-picture view of an individual and their metabolic health by using multiomic analysis. Multiomics entails looking at multiple “omics”–or information from a range of biological disciplines, such as epigenomics, lipidomics, genomics and transcriptomics–to better treat an individual patient.

The more researchers learn from individual patients, including horses, the better doctors will be able to treat every patient. My lab and others use multiomic analysis to generate data that may one day help us identify more effective and safer therapies for horses and–likely–people with metabolic conditions.The Conversation

Jane Manfredi is an associate professor of pathobiology and diagnostic investigation at Michigan State University. Manfredi receives funding from the Michigan Alliance for Animal Agriculture, USDA NIFA, AAVMC CIVME. Michigan State University provides funding as a founding partner of The Conversation US.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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New weight loss drugs are confusing, expensive, and inaccessible to some older patients https://www.popsci.com/health/older-patient-weight-loss-medication/ Mon, 31 Jul 2023 01:00:00 +0000 https://www.popsci.com/?p=559486
boxes of the diabetes drug Ozempic rest on a pharmacy counter
When adults with obesity lose weight, their risk of dying is reduced by up to 15 percent. MARIO TAMA / GETTY IMAGES

Clinical trials of medications like Ozempic haven’t included significant numbers of people ages 65 and older.

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boxes of the diabetes drug Ozempic rest on a pharmacy counter
When adults with obesity lose weight, their risk of dying is reduced by up to 15 percent. MARIO TAMA / GETTY IMAGES

This article was originally published on KFF Health News.

Corlee Morris has dieted throughout her adult life.

After her weight began climbing in high school, she spent years losing 50 or 100 pounds then gaining it back. Morris, 78, was at her heaviest in her mid-40s, standing 5 feet 10½ inches and weighing 310 pounds. The Pittsburgh resident has had diabetes for more than 40 years.

Managing her weight was a losing battle until Morris’ doctor prescribed a Type 2 diabetes medication, Ozempic, four months ago. It’s one in a new category of medications changing how ordinary people as well as medical experts think about obesity, a condition that affects nearly 4 in 10 people 60 and older.

The drugs include Ozempic’s sister medication, Wegovy, a weight loss drug with identical ingredients, which the FDA approved in 2021, and Mounjaro, approved as a diabetes treatment in 2022. (Ozempic was approved for diabetes in 2017.) Several other drugs are in development.

The medications reduce feelings of hunger, generate a sensation of fullness, and have been shown to help people lose an average of 15 percent or more of their weight.

“It takes your appetite right away. I wasn’t hungry at all and I lost weight like mad,” said Morris, who has shed 40 pounds.

But how these medications will affect older adults in the long run isn’t well understood. (Patients need to remain on the drugs permanently or risk regaining the weight they’ve lost.)

Will they help prevent cardiovascular disease and other chronic illnesses in obese older adults? Will they reduce rates of disability and improve people’s ability to move and manage daily tasks? Will they enhance people’s lives and alleviate symptoms associated with obesity-related chronic illnesses?

Unfortunately, clinical trials of the medications haven’t included significant numbers of people ages 65 and older, leaving gaps in the available data.

While the drugs appear to be safe — the most common side effects are nausea, diarrhea, vomiting, constipation, and stomach pain — “they’ve only been on the market for a few years and caution is still needed,” said Mitchell Lazar, founding director of the Institute for Diabetes, Obesity and Metabolism at the University of Pennsylvania Perelman School of Medicine.

Given these uncertainties, how are experts approaching the use of the new obesity medications in older people? As might be expected, opinions and practices vary. But several themes emerged in nearly two dozen interviews.

The first was frustration with limited access to the drugs. Because Medicare doesn’t cover weight loss medications and they can cost more than $10,000 a year, seniors’ ability to get the new drugs is restricted.

There is an exception: Medicare will cover Ozempic and Mounjaro if an older adult has diabetes, because the insurance program pays for diabetes therapies.

“We need Medicare to cover these drugs,” said Shauna Matilda Assadzandi, a geriatrician at the University of Pittsburgh who cares for Morris. Recently, she said, she tried to persuade a Medicare Advantage plan representative to authorize Wegovy for a patient with high blood pressure and cholesterol who was gaining weight rapidly.

“I’m just waiting for this patient’s blood sugar to rise to a level where diabetes can be diagnosed. Wouldn’t it make sense to intervene now?” she remembered saying. The representative’s answer: “No. We have to follow the rules.”

Seeking to change that, a bipartisan group of lawmakers has reintroduced the Treat and Reduce Obesity Act, which would require Medicare to cover weight loss drugs. But the proposal, which had been considered previously, has languished amid concerns over enormous potential costs for Medicare.

If all beneficiaries with an obesity diagnosis took brand-name semaglutide drugs (the new class of medications), annual costs would top $13.5 billion, according to a recent analysis in The New England Journal of Medicine. If all older obese adults on Medicare — a significantly larger population — took them, the cost would exceed the total spent on Medicare’s Part D drug program, which was $145 billion in 2019.

Laurie Rich, 63, of Canton, Massachusetts, was caught off guard by Medicare’s policies, which have applied to her since she qualified for Social Security Disability Insurance in December. Before that, Rich took Wegovy and another weight loss medication — both covered by private insurance — and she’d lost nearly 42 pounds. Now, Rich can’t get Wegovy and she’s regained 14 pounds.

“I haven’t changed my eating. The only thing that’s different is that some signal in my brain is telling me I’m hungry all the time,” Rich told me. “I feel horrible.” She knows that if she gains more weight, her care will cost much more.

While acknowledging difficult policy decisions that lie ahead, experts voiced considerable agreement on which older adults should take these drugs.

Generally, the medications are recommended for people with a body mass index over 30 (the World Health Organization’s definition of obesity) and those with a BMI of 27 or above and at least one obesity-related condition, such as diabetes, high blood pressure, or high cholesterol. There are no guidelines for their use in people 65 and older. (BMI is calculated based on a person’s weight and height.)

But those recommendations are problematic because BMI can under- or overestimate older adults’ body fat, the most problematic feature of obesity, noted Rodolfo Galindo, director of the Comprehensive Diabetes Center at the University of Miami Health System.

Dennis Kerrigan, director of weight management at Henry Ford Health in Michigan, a system with five hospitals, suggests physicians also examine waist circumference in older patients because abdominal fat puts them at higher risk than fat carried in the hips or buttocks. (For men, a waist over 40 inches is of concern; for women, 35 is the threshold.)

Fatima Stanford, an obesity medicine scientist at Massachusetts General Hospital, said the new drugs are “best suited for older patients who have clinical evidence of obesity,” such as elevated cholesterol or blood sugar, and people with serious obesity-related conditions such as osteoarthritis or heart disease.

Since going on Mounjaro three months ago, Muriel Branch, 73, of Perryville, Arkansas, has lost 40 pounds and stopped taking three medications as her health has improved. “I feel real good about myself,” she told me.

When adults with obesity lose weight, their risk of dying is reduced by up to 15 percent, according to Dinesh Edem, Branch’s doctor and the director of the medical weight management program at the University of Arkansas for Medical Sciences.

Still, weight loss alone should not be recommended to older adults, because it entails the loss of muscle mass as well as fat, experts agree. And with aging, the shrinkage of muscle mass that starts earlier in life accelerates, contributing to falls, weakness, the loss of functioning, and the onset of frailty.

Between ages 60 and 70, about 12 percent of muscle mass falls away, researchers estimate; after 80, it reaches 30 percent.

To preserve muscle mass, seniors losing weight should be prescribed physical activity — both aerobic exercise and strength training, experts agree.

Also, as older adults taking weight loss drugs eat less, “it’s critically important that their diet includes adequate protein and calcium to preserve bone and muscle mass,” said Anne Newman, director of the Center for Aging and Population Health at the University of Pittsburgh.

Ongoing monitoring of older adults having gastrointestinal side effects is needed to ensure they’re getting enough food and water, said Jamy Ard, co-director of Wake Forest Baptist Health’s Weight Management Center.

Generally, the goal for older adults should be to lose 1 to 2 pounds a week, with attention to diet and exercise accompanying medication management.

“My concern is, once we put patients on these obesity drugs, are we supporting lifestyle changes that will maintain their health? Medication alone won’t be sufficient; we will still need to address behaviors,” said Sukhpreet Singh, system medical director at Henry Ford’s weight management program.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

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5 space robots that could heal human bodies—or even grow new ones https://www.popsci.com/health/3d-printed-robots-space/ Tue, 25 Jul 2023 13:00:00 +0000 https://www.popsci.com/?p=558688
Futuristic doctor performs medical procedure on astronaut in space with robotic arms. Saturn can be seen outside of the spaceship window. Illustrated in blues and pinks.
Astronauts will have many robotic medical assistants on long-distance spaceflights. Zoë van Dijk for Popular Science

What would a space ER look like? Bio-inks, magnetic robots, and fungi-inspired tubes are just some of the futuristic options.

The post 5 space robots that could heal human bodies—or even grow new ones appeared first on Popular Science.

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Futuristic doctor performs medical procedure on astronaut in space with robotic arms. Saturn can be seen outside of the spaceship window. Illustrated in blues and pinks.
Astronauts will have many robotic medical assistants on long-distance spaceflights. Zoë van Dijk for Popular Science

IN ONE OF HUMANITY’S many possible futures, the fearless explorers tasked with climbing cloud-splitting mountains in oxygen-poor atmospheres or charting the low, darkened craters of various alien landscapes would never perish from injuries during perilous scouting expeditions. Nor would they fall ill or sustain genetic damage, thanks to supercharged hypersleep chambers that would heal otherwise fatal wounds. As it is today, astronauts don’t have the luxury of being unprepared—instead they must be equipped to deal with all sorts of medical mishaps, especially as they experiment with long-term spaceflight beyond the far side of the moon. 

Current human-rated spacecraft come stocked with emergency supplies to assist the crew, mostly everyday things like Band-Aids and aspirin, but also more specialized items like hydromorphone injections and those all-too-famous space blankets. While astronauts on the International Space Station (ISS) have relied on these, as well as telemedicine calls, to treat ailments and keep a clean bill of health, the fact is, being on another world could put a serious dent in the capacity of emergency medical care. NASA notes that all crew members are trained to handle the medical devices on board—but if a complex surgery is needed and the patient can’t be quickly flown back to Earth, the trainees would have to forge on with limited tools and experience. Thankfully, the worst they’ve faced so far is blood clots.

To plan for these inevitable crises, space agencies have latched on to the science of 3D bioprinting to help revolutionize regenerative medicine for life in the cosmic abyss and on the ground. Researchers have already made strides in bioprinting—the process of generating living cells and medical products in a manner similar to 3D printing—creating tissues, skin grafts, and eventually, whole organs for future transplants, as well as artificial bones that could become “spare parts” for injured astronauts. 

But as demand for smaller, more compact technologies grows, another class of machines has been rocketing to new heights. Capable of stretching, squeezing, bending, and even twisting to fulfill their tasks, “soft robots” are fabricated with materials inspired by living tissue such as human skin, instead of the rigid structures used in traditional remote-controlled systems. This allows robotic instruments to interact more safely with our bodies and lets surgeons perform complicated procedures with more accuracy and precision, says Sheila Russo, an assistant professor at Boston University who specializes in mechanical engineering design for miniaturized surgical robots.

“I work in a field where we build robots that can help patients survive,” Russo explains. “We as engineers listen to people that have problems, and we want to engineer a robotic solution to it.” She likes to point to Big Hero 6’s Baymax as a fictional example of an autonomous soft robot that successfully heals people, either with the various medical devices it’s equipped with or by offering helpful advice. 

Though the doodads in development won’t be able to simply hug anyone’s aches and pains away (yet), they’re lightweight and relatively cheap to produce, making them easy to transport to remote locations, says Russo. For instance, one lab at King’s College in the UK is trying to address the limitations of ultrasound by creating adaptable soft robots that can withstand high-energy sound waves. 

As these prototypes gain traction within the greater medical field, there’s still a long list of quirks and challenges to tackle. But their endless potential could help humans endure extreme circumstances both on Earth and in the stars.  

Flexible In Situ 3D Bioprinter 

Dream Team: The University of New South Wales

Function: Swiss Army knife 

ETA: 5–7 years

flexible medical tube and 3-d printing head for medical procedures in space. on orange background.
F3DB’s printing head uses hydraulics to flex in three different directions. UNSW Medical Robotics Lab

Acting much like a medical endoscope, this tiny, multifunctional robotic arm (about 0.8 inches in diameter) can be used to fix damaged body parts directly inside a patient’s body. Conventional devices rely on large desktop printers to create artificial tissues, which can then either be kept and grown until mature or implanted directly into the body. But this high-cost method often poses risks, such as structural damage to the faux organ during transport, tissue injuries, and contamination once the part is brought out of a sterile environment. 

The flexible in situ 3D bioprinter (F3DB), on the other hand, works by accessing hard-to-reach areas of the body via small incisions or through natural orifices such as the mouth or anus. “About 90 percent of the human body has a tubular structure,” says Thanh Nho Do, a senior lecturer at UNSW Sydney and one of the team leads for the project. “If you can develop the technology, [robots] can navigate along this way in any desired direction.” 

Once positioned in the target area, F3DB’s multiaxis printing head, which is mounted on a snakelike extendable arm, bends its nozzle to print in three different directions, delivers water to wash away blood and tissue, and acts as an electric scalpel to flag and sever cancerous lesions or tumors. It’s so versatile in its applications that it could potentially be used as an all-in-one surgical tool for medical professionals, says Do. 

Although this tool is still more than half a decade away from human trials, researchers plan to continue using haptic technology—sensor-filled gadgets that can convey tactile information—to manipulate the device, so the system could one day be easily controlled in extreme environments, such as on space stations or in lunar or Martian settlements. 

The 3D BioFabrication Facility 

Dream Team: Redwire Space 

Function: Knee replacement

ETA: 5–10 years

Astronaut using BFF 3D printer on ISS
ISS astronauts have been putting BFF to the test since January 2023. NASA

A recent addition to the ISS, the 3D BioFabrication Facility (BFF) and Advanced Space Experiment Processor are two separate payloads that combine to make a powerful 3D bioprinting laboratory. In collaboration with the ISS National Lab and the Uniformed Services University of the Health Sciences Center for Biotechnology, Redwire’s researchers plan to use it to re-create part of a human knee in space—specifically the meniscus, cartilage that helps absorb shock and stabilizes the joint. If successful, it could be the first step in helping to treat severe knee injuries for US military service members on Earth. 

“A torn meniscus is one of, if not the most common issue that our military have,” says Ken Savin, the aerospace manufacturing company’s chief scientist. “[It’s] a day-to-day issue that a lot of people have and translates to the general population, so it’s a great target to go after.” The printer itself, which is about the size of a dorm fridge, cultures pre-harvested adult stem cells into a solution called bio-ink. 

After being warmed, fed with liquid nutrients, and stimulated to grow, the mixture can be layered into precise, ultrafine structures aboard the ISS and then shipped back to Earth. Strong gravitational forces cause the soft tissues to spread apart like puddles of water, but in space, they can be expected to hold their form due to the microgravity inherent to the ISS, says Savin. 

“When you remove gravity, you open up a whole new field of science,” Savin says. “It allows you to do things and see things that were otherwise hidden.” Once the ISS is decommissioned (which will happen after 2030), Redwire aims to continue advancing its biomanufacturing research aboard Blue Origin’s planned space station, Orbital Reef. 

While the company is now still in the early planning stages of the meniscus project, Savin expects it to be a stepping stone to many other medical breakthroughs, including individualized heart patches that restore cardiac function. Depending on the size of the 3D-printed tissue, production would likely take less than a day. And that’s not the only way BFF would move anatomical technologies along. With future commercialization, the portable lab could help organ-donation hopefuls avoid long wait times and subpar inorganic replacements.

The Soft Growing Robot

Dream Team: University of Minnesota

Function: Infinitely stretching tube 

ETA: 10+ years

In a lab experiment, the plant-inspired robot grows out of a liquid solution to move along a track.
In a lab experiment, the plant-inspired robot grows out of a liquid solution to move along a track. Matthew Hausladen / Ellison Group / University of Minnesota

Inspired by plant roots, pollen tubes, and fungi, engineers at the University of Minnesota recently developed a process that allows soft robots to exhibit a level of movement called tip growth, previously seen only in nature. Organisms use this method to add new cells to the ends of their bodies, enabling them to generate large, specific structures over time, cross harsh terrain with ease, and navigate via external stimuli like light or chemical signals. 

In 2022, researchers were able to mimic this process in their own robotic prototype by using a technique called photopolymerization, which uses light to transform liquid molecules into solid materials. It’s a popular 3D-printing strategy in the medical field, specifically for creating accurate anatomical models of patients’ bodies, but in this novel application, it allows a soft robot to build its own body from a liquid monomer solution as it navigates complex environments. 

Capable of a number of exploratory tasks as it slinks along its path, this inchworm-like device can grow up to speeds of about 5 inches per minute, stretch up to about 5 feet, and avoid and even deflect obstacles to reach the deepest recesses of the human body. The tool could be especially helpful for medical fields like gynecology and urology, according to Timothy Kowalewski, an associate professor of mechanical engineering at the University of Minnesota and a member of the project. He also sees it making a difference in procedures like automated intubation and heart attack treatment, where soft catheters are pushed through blood vessels to stabilize a patient. 

The BioPrint FirstAid Handheld Bioprinter

Dream Team: The German Aerospace Center

Function: Cellular Band-Aid

ETA: 5–10 years

small gunlike tool with red wheels floats in zero gravity
The handheld bioprinter made its debut on the ISS in early 2022. Matthias Maurer / ESA / NASA

Not all soft robots are meant to turn humans into cyborgs with fancy mechanical parts. One bioprinter prototype, developed by the German Aerospace Center, was designed to accelerate an astronaut’s own healing process, says Michael Becker, the project manager for the program. 

Like other innovations in space-centered healthcare, the BioPrint FirstAid Handheld Bioprinter will use cells collected from astronauts before the mission to prepare cartridges of personalized bio-ink for emergency wound treatment, like fixing up superficial lesions and even bone fractures. Likely the first-ever handheld version of a bioprinter in space, the device resembles a compact glue gun—complete with a printing head, guide wheels, and room to hold two bio-ink cartridges for easy access and use. 

While the machine was created to be completely manually operated, the actual printing process takes only a few minutes, Becker explains. “You basically put the printer on your arm or somewhere else and drive over the injured skin.” The nozzle then pushes the solution out to create a plaster-like wound covering. In 2021, ESA astronaut Matthias Maurer demonstrated the technology using simulated cells during a training session on Earth, and he did it again in 2022 during his Cosmic Kiss mission on the ISS.

Having a handheld bioprinter along on a long-duration spaceflight would allow the crew to quickly provide personalized medical care, but the creators need to clear two hurdles first: determining just how many bio-ink cartridges would be needed for a given interplanetary journey and figuring out how to store them in a stable environment. “The challenge right now [is] to create ink where these cells can survive for long-term missions,” says Becker. 

The team hopes the astronaut-friendly tool finds alternative uses, such as in research missions to harsh environments like Antarctica or for bedridden patients. 

The Ferromagnetic Soft Catheter Robot

Dream Team: Huazhong University of Science and Technology

Function: Magnetic bioprinter 

ETA: Decades

Tube-like gray robot draws different shaped with orange bio-ink
The magnetic catheter produces complex designs with bio-ink. Huazhong University of Science and Technology

Another robot designed to print tissues and organs inside the human body in a minimally invasive manner, the ferromagnetic soft catheter robot (FSCR) stands out from its counterparts because it relies on magnets to move about. 

“This work provides two very new ideas,” says Jianfeng Zang, a professor at Huazhong University of Science and Technology whose work revolves around bridging the gap between hard machines and the soft human body. “One, in that we can do minimally invasive bioprinting, and the second one is that we use a magnetic system to do it.” 

Usually, these kinds of medical machines use motors to propel themselves through the patient’s body. But Zang’s group disperses particles of the rare-earth metal neodymium down the center of their catheter-shaped robot, which also doubles as a bioprinter capable of fabricating complex structures. The device can be swiftly steered via an external computer-controlled magnet to transport materials like drugs or injectable bio-inks through narrow, winding environments. It’s also highly durable because neodymium retains its magnetism for hundreds of years.

Researchers are working to miniaturize the device, which is currently a fraction of an inch, even further. It could one day offer physicians finer control over the instrument’s movements and allow them to complete complex procedures without radioactive X-rays. 

“We just want to use magnetic robots to treat some disease or do some precise surgery that existing technology cannot do,” says Zang. “It’s our dream.”

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Flying with human organs for transplant is tricky—a new law could help https://www.popsci.com/health/organ-transplant-air-travel/ Mon, 24 Jul 2023 19:00:00 +0000 https://www.popsci.com/?p=558599
Airplane in a clear sky.
A provision to change the life-or-death process by which human organs are flown commercially from donor to recipient is tucked into the hundreds of pages of legislative language to reauthorize the Federal Aviation Administration. The measure aims to change regulations and move organs to the cabin from an aircraft’s cargo hold. Deposit Photos

Where organs are stowed during flights has been a long-standing issue for organ procurement organizations.

The post Flying with human organs for transplant is tricky—a new law could help appeared first on Popular Science.

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Airplane in a clear sky.
A provision to change the life-or-death process by which human organs are flown commercially from donor to recipient is tucked into the hundreds of pages of legislative language to reauthorize the Federal Aviation Administration. The measure aims to change regulations and move organs to the cabin from an aircraft’s cargo hold. Deposit Photos

This article was originally published on KFF Health News.

What do kidney and pancreas transplants have to do with airplane regulations?

Tucked into the hundreds of pages of legislative language to reauthorize the Federal Aviation Administration is a provision to change the life-or-death process by which human organs are flown commercially from donor to recipient.

But where on the plane organs are stowed during flights has been a long-standing issue for organ procurement organizations.

The sweeping measure, which is pending in Congress and faces a Sept. 30 deadline, aims to change regulations and move organs to the cabin from an aircraft’s cargo hold. Organizations managing organ transport consider it an opportunity to secure legislative relief from a system they say adds more hurdles to the task of shipping organs.

It used to be that a member of a transplant team could take a packaged organ to a plane’s gate and hand it off to the aircraft’s crew, who would stow it in the cockpit or on the flight deck. This access “allowed us to really expedite the process,” said Jeff Orlowski, president and CEO of LifeShare Oklahoma, a nonprofit organ procurement organization in the state. But the terrorist attacks of 9/11 led to tighter security protocols, including a rule that permitted only people with tickets to go through Transportation Security Administration checkpoints.

“In our case, we don’t have a ticket,” said Casey Humphries, logistics service line leader of the United Network for Organ Sharing, the nonprofit contracted by the federal government to manage the nation’s transplant system. “We’re not booked as a passenger on a plane,” she said. Instead, they’re part of the relay network bringing the organs to people in need. Airport employees who work behind security checkpoints have an airport badge and usually get in through a designated entrance.

Another consequence of the 2001 policy changes was that donor organs flown on commercial airplanes—which are mostly kidneys—were stashed in cargo spaces below the wing along with boxes and luggage, said Humphries.

But shipping organs as cargo requires they be at the airport for loading one to two hours before takeoff. “That’s a significant time before the wheels go up for the plane,” said Orlowski. And that variable—the “hours that the organ is going to just sit, going nowhere”—has to be factored into decisions about where it can be sent, he said. Donated organs can’t be treated like a golf bag or an Amazon box. They are delicate and have an imminent expiration date, which for kidneys is usually within 24 hours of surgical removal.

Since January 2022, around 80 percent of organs recovered in Oklahoma were sent to another state to be transplanted, Orlowski said. And of the organs LifeShare recovers, about 35 percent of them are flown commercially. Since kidneys can survive in a cooler longer than other organs, nearly all organs that travel on commercial flights are kidneys.

The first choice for transporting an organ, he said, is usually to drive it to its destination; it’s cheaper, and the transplant team can be more watchful.

But that’s not always an option, especially in rural areas. Orlowski said there are only two transplant centers within driving distance of LifeShare’s Oklahoma City base, in Dallas and Fort Worth, Texas. So his team relies on commercial airlines for transportation.

The current air travel security rules also cause geographic disparities, as fewer cargo-carrying planes fly in and out of smaller airports in rural areas, compared with airports in bigger cities.

“We need something that is available 24 hours a day because organs are available 24 hours a day,” Humphries said.

Charter planes can be a backup option, but one flight can cost organ procurement organizations thousands of dollars, whereas cargo shipping costs usually come in at less than $500 per flight, Orlowski said.

Although the security protocol has been in place for more than two decades, transplant advocates say this is the first time they have sought a legislative reversal, and they are optimistic about the outcome.

The provision to allow organs back in cabins is included in both the Senate and House versions of the reauthorization bill. Some hot-button parts of the bill, though, such as an increase in the mandatory retirement age for pilots, could stall progress. The House Transportation and Infrastructure Committee approved its version on June 14, and at press time it was being debated on the House floor. The Senate Committee on Commerce, Science and Transportation is expected to consider its version this month, according to Senate staffers.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

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No guts left behind: Iceland’s quest to repurpose fish waste https://www.popsci.com/environment/iceland-fish-waste/ Thu, 20 Jul 2023 01:00:00 +0000 https://www.popsci.com/?p=557696
Cod fish heads
Cod makes for good eating. But with a bit of creativity, researchers have discovered that the rest of the animal—once discarded as scraps—can do so much more. Deposit Photos

Cod heads, skin, blood. You name it, there’s an initiative to turn it into a high-value product and divert it from the trash.

The post No guts left behind: Iceland’s quest to repurpose fish waste appeared first on Popular Science.

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Cod fish heads
Cod makes for good eating. But with a bit of creativity, researchers have discovered that the rest of the animal—once discarded as scraps—can do so much more. Deposit Photos

This article was originally featured on Hakai Magazine, an online publication about science and society in coastal ecosystems. Read more stories like this at hakaimagazine.com.

A bleary-eyed predawn traveler walking through the arrivals hall of Iceland’s Keflavik Airport blinks at a sight that’s hard at first to register: an enormous advertisement showing a shirtless man holding an infant. The man’s torso and visible arm show a swath of pucker-patterned skin. He looks half-aquatic, like a member of some superhero universe.

As it happens, this sleep-deprived analysis isn’t far off. The baby-holding man, Pétur Oddsson, is a power station worker. In 2020, he endured a 60,000-volt electrical shock; it left almost half his body covered in deep thermal burns that charred layers of his skin off. Such deep and extensive burns can be fatal—skin damaged in this way can’t make new cells to regenerate, and infections can easily set in. But Oddsson’s life was spared by an ingenious invention: grafted cod skin—7,000 square centimeters of it. The procedure adorned Oddsson’s upper body with the permanent, distinct imprint of scales.

Oddsson’s cod skin grafts are a marvel of medical technology. But they also represent something else: the manifestation of an unusual and ambitious experiment in environmental efficiency. The skin grafts are just one of a slew of products—including Omega-3 capsules, cold virus pretreatment sprays, and dog snacks—made from what was once Iceland’s cod catch detritus. They come largely from the efforts of 100% Fish—a project spurred by the incubator Iceland Ocean Cluster in collaboration with research institutes and private companies to determine how to repurpose byproducts from the country’s US $2-billion seafood sector.

So far, enterprising Icelanders have unlocked uses for almost 95 percent of a cod—a pretty recent jump forward. In 2003, people only knew what to do with about 40 percent of the fish.

Árni Mathiesen, the cluster’s senior adviser and the country’s former fisheries minister, says the 100% Fish Project has created jobs and manifested once-scarce domestically produced goods. It has also, adds Alexandra Leeper, the cluster’s head of research and innovation, provided lower-impact fish meal for a burgeoning aquaculture industry. Relatedly, 100% Fish is looking beyond cod, too. A company called Nordic Fish Leather is upcycling farmed salmon skin into leather for accessories and another, Primex, is extracting chitosan from the shells of wild-caught Atlantic northern shrimp, which can be used as a blood-clotting agent.

The cod skin grafts are the brainchild of Fertram Sigurjonsson, a chemist and the founder of biotech company Kerecis, which is part of the 100% Fish Project. The grafts come in several sizes—wide strips, for large wounds; glove shapes, for hands; and granules, which act like putty in smaller wounds—and have been used to treat thousands of burn victims, diabetes patients with open wounds, and women with infected C-sections. Doctors can perform some of these procedures with pigskin grafts, but those are harvested from animals engineered for the purpose. The fish skin, conversely, comes from cod caught for human consumption by fishermen in Sigurjonsson’s northwestern hometown of Isafjordur. (Fishermen who also own valuable shares in his company.)

Sigurjonsson says Kerecis currently transforms a mere 0.01 percent of Icelandic cod skins into grafts. But as demand grows, and as Kerecis’ research and development department determines more uses—they’re investigating breast reconstruction—he’s looking to expand.

By weight, a cod is about eight percent skin. Beyond making for good grafting material, cod skin is rich in collagen, a supplement for human skin, ligament, and bone health. Cod skin easily sheds this protein when it’s boiled in water with enzymes, says Hrönn Margrét Magnúsdóttir. She’s the founder of a collagen supplement and energy drink company called Feel Iceland, which uses collagen derived from 700 tonnes of fish skin per year.

Bones account for at least 35 percent of a cod’s weight. Icelandic companies have long dried fish heads and spines with the country’s abundant geothermal energy and exported them to Nigeria, where they’re the base of a protein-rich soup. But Margrét Geirsdóttir, a project manager at Matís, a food and biotechnology research institute that partners with the Iceland Ocean Cluster, says the unpredictability of that market has sent researchers looking for new applications—such as extracting calcium for supplements.

By far the most challenging holdouts to whole-fish use are the blood and eyeballs, says Geirsdóttir.

According to Icelandic lore, squeezing the liquid from a redfish eyeball onto a wound prevents infection. Matís scientists followed this up, studying whether cod eyeballs might have antiseptic properties. No such luck. They also had a project, says Geirsdóttir, to see whether the eyes contained valuable fats. They do, she says, “but it’s such a low amount and you would need to [extract] it by hand, so it’s not paying off.”

Fish blood, accounting for 10 percent of a fish’s weight, might be used to make products like those made from the blood of land animals, such as sausage filler, fish feed, or fertilizer. Yet Geirsdóttir says the hardest part about working with fish blood is collecting it. On a commercial fishing boat, cod are quickly bled to maintain their freshness. Convincing skeptical fishermen to invest in storing the fish intact means proving the endeavor is worthwhile.

There is an optimistic precedent, however. Fishermen once tossed cod livers overboard; now they’re an expensive delicacy that fishermen are happy to preserve. What changed? Several years back, Geirsdóttir says, fishermen began to see high profits from the sale of cod liver. “Then they started to see the value in it,” she says.

This article first appeared in Hakai Magazine and is republished here with permission.

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FDA approves long-acting medication to protect babies from RSV https://www.popsci.com/health/infant-rsv-fda-medication/ Tue, 18 Jul 2023 13:00:00 +0000 https://www.popsci.com/?p=557378
A preterm baby in an incubator in a neonatal intensive care unit. RSV sends about 58,000 children under five to the hospital every year in the United States.
RSV sends about 58,000 children under five to the hospital every year in the United States.

The new treatment was 78 percent effective at preventing hospitalizations due to the lung-attacking virus in clinical trials.

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A preterm baby in an incubator in a neonatal intensive care unit. RSV sends about 58,000 children under five to the hospital every year in the United States.
RSV sends about 58,000 children under five to the hospital every year in the United States.

On Monday July 17, the Food and Drug Administration approved the first long-acting medication  to protect babies and toddlers against respiratory syncytial virus (RSV). The lung-attacking virus sends about 58,000 children under five to the hospital and kills 100 to 300 infants every year in the United States. 

[Related: Flu and RSV hybrid virus studied in a lab for the first time.]

Nirsevimab is a ready-made injectable antibody that can bind to RSV and block the virus from infecting healthy cells. It is not a vaccine, but instead, is a form of passive immunity. 

For most healthy people, RSV manifests as a cold, but the virus can be life-threatening for the elderly and the very young. Nirsevimab was approved for infants and children up to two years old who face increased risk of severe RSV. Babies can receive a single injection to protect against their first RSV season, which typically starts in the fall and peaks in the winter in the US. Children up to two can then receive a second dose during their next RSV season. 

“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research John Farley said in a statement. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system.” 

Nirsevimab will be sold under the brand name Beyfortus and is already approved for use in the United Kingdom, Europe, and Canada. Pharmaceutical company Sanofi, who developed the drug with AstraZeneca, did not immediately say that the price of the treatment would be in the US.  

According to an FDA analysis, nirsevimab was roughly 70 percent effective at reducing the risk that a baby would need to see a doctor for RSV and was about 78 percent effective at preventing hospitalizations compared with a placebo in the clinical trials that led to the drug’s approval. It was generally safe and well tolerated in the trials, with less than one percent of babies having skin reactions after the shots that went away with treatment. 

[Related: How our pandemic toolkit fought the many viruses of 2022.]

“We run this gauntlet every year — RSV season,” pediatric infectious disease specialist at the Cleveland Clinic in Ohio Frank Esper told CNN “We see a lot of these infants. They come in; they can’t breathe. That’s the problem. That’s what RSV does. It causes so much swelling and secretions in their breathing tubes, called the bronchioles, that they just can’t get enough oxygen.”

Advisers to the Centers for Disease Control and Prevention will meet in early August to recommend exactly who should receive the drug. recommend exactly who should get the drug.

The approval is welcome after multiple decades of setbacks in research for RSV. The FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer in May and the agency is expected to make a decision on a vaccine for pregnant people next month.

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FDA approves first over-the-counter birth control pill in the US https://www.popsci.com/health/nonprescription-birth-control-fda/ Thu, 13 Jul 2023 14:15:00 +0000 https://www.popsci.com/?p=556660
Rows of birth control pills with the days of the week on the label.
About half of the 6.1 million annual pregnancies in the US are unintended, which have been linked to negative maternal and perinatal outcomes. Deposit Photos

The pill is sold under the brand name Opill and should be available in early 2024.

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Rows of birth control pills with the days of the week on the label.
About half of the 6.1 million annual pregnancies in the US are unintended, which have been linked to negative maternal and perinatal outcomes. Deposit Photos

On July 13, the Food and Drug Administration (FDA) approved an over-the-counter birth control pill that can be sold without a prescription for the first time in the United States. The pill is sold under the brand name Opill and will be the most effective birth control method available without a prescription. Oral contraceptives are more effective in preventing pregnancy than barrier methods such as condoms, according to the Cleveland Clinic.

[Related: Over-the-counter birth control pills could change reproductive care in the US.]

Nonprescription availability of the drug, generic name norgestrel, should reduce barriers to access by allowing individuals to obtain oral contraception without seeing a health care provider first, according to the FDA. Roughly half of the 6.1 million annual pregnancies in the US are unintended, which have been linked to negative maternal and perinatal outcomes.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni said in a statement today. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non prescription contraceptive methods in preventing unintended pregnancy.”

Opill’s manufacturer Perrigo Company said that it will most likely be available in stores and online retailers in early 2024, but did not specify how much the medication would cost. However, Perrigo’s global vice president for women’s health Frédérique Welgryn, called the move a “groundbreaking expansion for women’s health in the US,” and said that the company was committed to making Opill “accessible and affordable to women and people of all ages.” 

Medicine photo
Opill is a once-daily single hormone birth control pill. CREDIT: Perrigo via PR Newswire.

Perrigo submitted several years of research to the FDA that demonstrates that women can understand and follow the instructions for using the pill. Today’s approval also came despite some concerns from FDA scientists on whether individuals with some underlying medical conditions would understand that they shouldn’t take Opill.

Like with many birth control pills, Opill should be taken at the same time every day for effectiveness. The most common side effects include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.

Since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health overturned the federal right to abortion in June 2022, accessibility to contraception has become an increasingly  urgent issue. Even before that decision, the move to develop an over-the-counter birth control pill received support from groups such as the American Medical Association and the American College of Obstetricians and Gynecologists.

[Related: What we know about hormonal birth control and breast cancer risk.]

“We’re thrilled by the FDA’s historic decision to approve Opill as the first ever over-the-counter birth control pill,” executive director of the National Latina Institute for Reproductive Justice and Free the Pill coalition steering committee member Lupe M. Rodríguez said in a statement. “Over-the-counter access to birth control will greatly reduce the barriers that prevent Latinas/xs from getting the care they need, including barriers due to transportation, cost, language, and documentation. If this is implemented correctly, expanding access to birth control will allow our communities the freedom to make meaningful decisions about our lives and futures. Now we must ensure that this safe and effective birth control pill is affordable and covered by insurance.”

Today’s FDA action only applies to Opill which is in an older class of contraceptives that are sometimes called minipills. These contain a single synthetic hormone and typically have fewer side effects than combination hormone pills. 

Some women’s health advocates hope that this major decision will signal more over-the-counter birth control options and even for abortion pills in the future. 

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This magnetic robot could worm its way into human blood vessels https://www.popsci.com/technology/magnet-soft-worm-robot/ Mon, 10 Jul 2023 14:30:00 +0000 https://www.popsci.com/?p=554646
Screenshot of inching magnetic soft robot
Magnetic strategic portions of this soft robot allows it to move in three dimensions. MIT / Ankeeva et al

Just one magnetic field can create 'a movement-driving profile of magnetic forces.'

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Screenshot of inching magnetic soft robot
Magnetic strategic portions of this soft robot allows it to move in three dimensions. MIT / Ankeeva et al

Researchers at MIT have created a tiny, cucumber-inspired soft robot capable of scooting around otherwise hard-to-reach, three-dimensional environments using a single, weak magnetic field. As first detailed last month in an open access paper published with Advanced Materials, an inchworm-like mechanism made from strategically magnetized rubber polymer spirals shows immense promise in maneuvering through spaces as tiny as human blood vessels.

[Related: Seals provided inspiration for a new waddling robot.]

Before this newest wormbot, locomotive soft bots required moving magnetic fields to control their direction and angle. “[I]f you want your robot to walk, your magnet walks with it. If you want it to rotate, you rotate your magnet,” Polina Ankeeva, the paper’s lead author and a professor of materials science and engineering and brain and cognitive sciences, said in a statement. “If you are trying to operate in a really constrained environment, a moving magnet may not be the safest solution,” Ankeeva added. “You want to be able to have a stationary instrument that just applies [a] magnetic field to the whole sample.”

As such, the MIT research team’s new design isn’t uniformly magnetized like many other soft robots. By only magnetizing select areas and directions, just one magnetic field can create “a movement-driving profile of magnetic forces,” according to MIT’s announcement.

Medicine photo

Interestingly, engineers turned to cucumber vines’ coiled tendrils for inspiration: Two types of rubber are first layered atop one another before being heated and stretched into a thin fiber. As the new thread cools, one rubber contracts while the other retains its form to create a tightly wound spiral, much like a cucumber plant’s thin vines wrapping around nearby structures. Finally, a magnetizable material is threaded through the polymer spiral, then strategically magnetized to allow for a host of movement and directional options.

Because of each robot’s customizable magnetic patterns, multiple soft bots can be individually mapped to move in different directions when both exposed to a single, uniform weak magnetic field. Additionally, a subtle field manipulation allows the robots to vibrate—thus allowing the tiny worms to carry cargo to a designated location, then shake it off to deliver a payload. Because of their soft materials and relatively simple manipulation, researchers believe such mechanisms could be used in biomedical situations, such as inching through human blood vessels to deliver a drug at a precise location.

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Alzheimer’s-slowing drug Leqembi gains full FDA approval https://www.popsci.com/health/alzheimers-drug-fda-approval/ Fri, 07 Jul 2023 17:00:00 +0000 https://www.popsci.com/?p=554090
A doctor points to multiple MRI's of the brain. A newly approved drug targets beta-amyloid, a brain protein that has long been believed by scientists to be one of the underlying causes of Alzheimer’s disease.
The newly approved drug targets beta-amyloid, a brain protein that has long been believed by scientists to be one of the underlying causes of Alzheimer’s disease. Deposit Photos

The medication should be widely covered by Medicare.

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A doctor points to multiple MRI's of the brain. A newly approved drug targets beta-amyloid, a brain protein that has long been believed by scientists to be one of the underlying causes of Alzheimer’s disease.
The newly approved drug targets beta-amyloid, a brain protein that has long been believed by scientists to be one of the underlying causes of Alzheimer’s disease. Deposit Photos

On July 6, the Food and Drug Administration (FDA) fully approved the first drug shown to slow down Alzheimer’s disease. Sold under the brand name Leqembi (generic name lecanemab), this is the first time that a drug meant to slow the disease’s progression, and not only target its symptoms, has been granted full regulatory approval. 

[Related: One big reason why Alzheimer’s might be going undetected in the US.]

Leqembi is manufactured by Japanese drugmaker Eisai and the United States-based drugmaker Biogen. The drug targets beta-amyloid, a brain protein that has long been believed by scientists to be one of the underlying causes of Alzheimer’s. 

During a phase 3 clinical trial of the new drug, disease progression was slowed by 27 percent over an 18-month period in 1,795 patients with mild cognitive impairment or early-stage Alzheimer’s. The medication also reduced sticky beta-amyloid plaques that can accumulate in the brains of people with the disease.

“[This] action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research Teresa Buracchio said in a press release. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

The new approval means that Leqembi should be widely covered by Medicare, which primarily serves adults 65 and older. Until this approval, the federal insurance program has only covered the cost of Leqembi for patients in certain clinical trials. This expanded coverage means that an estimated one million Medicare patients are potential candidates for the treatment, and that people with Medicare who are in the early stages of Alzheimer’s could access the drug at an affordable price. Both companies have said the treatment will cost roughly $26,500 annually without insurance.

“It’s not something that’s going to stop the disease or reverse it,” Sanjeev Vaishnavi, director of clinical research at the Penn Memory Center, told NPR. “But it may slow down progression of the disease and may give people more meaningful time with their families. It’s very exciting that we’re targeting the actual pathology of the disease.”

In January, Leqembi received accelerated approval from the FDA due to its ability to remove beta-amyloid from the brain in those in early stages of the disease that affects more than 6.5 million Americans. Full or traditional approval reflects the FDA’s assessment that the drug also helps preserve thinking and memory. 

[Related: One secret to excellent memory in old age? Giant neurons.]

The Alzheimer’s Association has previously worked to accelerate the drug’s approval, and called it “an important development for people living with Alzheimer’s disease and their families.” However, some critics have mentioned the lack of diversity in the drug’s testing pool—specifically Black patients.

According to the FDA, Alzheimer’s disease is currently irreversible, progressive, and slowly destroys memory and thinking skills. Eventually, the ability to carry out simple tasks. Its specific cause is unknown, but it is generally characterized by changes in the brain. Some of these changes include the formation of amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections.

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Facebook could be tracking your online Plan B or HIV test purchases https://www.popsci.com/technology/pharmacy-privacy-hiv-test-plan-b/ Tue, 04 Jul 2023 01:00:00 +0000 https://www.popsci.com/?p=553043
Person making online purchase.
Some retailers appeared to be taking steps to limit tracking on sensitive items. Pexels

Twelve of the largest drug stores in the U.S. sent shoppers’ sensitive health information to Facebook or other platforms.

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Person making online purchase.
Some retailers appeared to be taking steps to limit tracking on sensitive items. Pexels

This article was co-reported by The Markup and KFF Health News.

Looking for an at-home HIV test on CVS’ website is not as private an experience as one might think. An investigation by The Markup and KFF Health News found trackers on CVS.com telling some of the biggest social media and advertising platforms the products customers viewed.

And CVS is not the only pharmacy sharing this kind of sensitive data.

We found trackers collecting browsing- and purchase-related data on websites of 12 of the U.S.’ biggest drugstores, including grocery store chains with pharmacies, and sharing the sensitive information with companies like Meta (formerly Facebook); Google, through its advertising and analytics products; and Microsoft, through its search engine, Bing.

The tracking tools, popularly called “pixels,” collect information while a website runs. That information is often sent to social media firms and used to target ads, either to you personally or to groups of people that resemble you in demographics or habits. In previous investigations, The Markup found pixels transmitting information from the Department of Education, prominent hospitals, telehealth startups, and major tax preparation companies.

Pharmacy retailer websites’ pixels send a shopper’s IP address—a sort of mailing address for a person’s computer or household internet—to social media giants and other firms. They also send cookies, a way of storing information in a user’s browser that in this case helps track a user from page to page as the user browses a retailer’s site. Cookies can sometimes also associate individuals on a site with their account on a social media platform. In addition to the IP address and cookies, the pixels often send information about what you’ve clicked or bought, including sensitive items, such as HIV tests.

“HIV testing is the gateway to HIV prevention and treatment services,” said Oni Blackstock, the founder of Health Justice and a former assistant commissioner for the New York City Bureau of HIV/AIDS Prevention and Control, in an interview.

“People living with HIV should have control over whether someone knows their status,” she said.

Many retailers shared other detailed interaction data with advertising platforms as well. Ten of the retailers we examined alerted at least one tech platform when shoppers clicked “add to cart” as they shopped for retail goods, a capacious category that included sensitive products like prenatal vitamins, pregnancy tests, and Plan B emergency contraception.

Supermarket giant Kroger, for instance, informed Meta, Bing, Twitter, Snapchat, and Pinterest when a shopper added Plan B to the cart, and informed Google and Nextdoor, a social media platform on which people from the same neighborhood gather in forums, that a shopper had visited the page for the item. Walmart informed Google’s advertising service when a shopper browsed the page of an HIV test, and Pinterest when that shopper added it to the cart.

A previous investigation from The Markup found that Kroger used loyalty cards to track, analyze, and sell an array of data about customers to advertisers.

Using Chrome DevTools, a tool built into Google’s Chrome browser, The Markup and KFF Health News visited the websites of 12 of the U.S.’ biggest drugstores and examined their network traffic. This monitoring tool allowed us to see what information about shopping habits and, in some cases, prescriptions, were sent to third parties.

Over the course of the investigation, retailers frequently changed their trackers—sometimes activating them, sometimes removing them. Some retailers appeared to be taking steps to limit tracking on sensitive items.

For example, Walgreens’ website prevented some trackers from activating on the pages of some products, which included Plan B and HIV tests. This code didn’t prevent all tracking, though: Walgreens’ site continued sending Pinterest information about those sensitive items a user added to the cart.

Walgreens shared a new policy after learning of The Markup and KFF Health News’ findings. Spokesperson Fraser Engerman said that while the chain already had a “robust privacy program,” it would no longer share browsing data related to reproductive health and HIV testing. Engerman also told us that “Pinterest confirmed that the data will be deleted and that it has not been used for advertising purposes.” Crystal Espinosa, a spokesperson for Pinterest, said the company “can confirm that we will be deleting the data Walgreens requested.”

The pharmacy vs. the pharmacy aisle

In the U.S., drugstores and grocery stores with associated pharmacies are only partially covered by the Health Insurance Portability and Accountability Act, or HIPAA. The prescriptions picked up from the pharmacy counter do have this protection.

But in a separate section, sometimes confusingly called the pharmacy aisle, stores also often sell over-the-counter medications, tests, and other health-related products. Consumers might think such purchases have similar protections to their prescriptions, but HIPAA only covers the pharmacy counter’s clinical operations, such as dispensing prescriptions and answering patients’ questions about medication.

This distinction can be confusing enough inside the brick-and-mortar location of a retailer. But the line can become even harder to make out on a website, which lacks the clarifying delineations of physical space.

What’s more, descriptions about what will happen with retail data are generally in retailers’ privacy policies, which can usually be found in a link at the bottom of their webpages. The Markup and KFF Health News found them murky at best, and none of them were specific about the parts of the site that were covered by HIPAA and the parts that weren’t.

In the “Privacy Notice for California Residents” part of its privacy policy, Kroger says it processes “personal information collected and analyzed concerning a consumer’s health.” But, the policy continues, the company does not “sell or share” that information. Other information is sold: According to the policy, in the last 12 months, the company sold or shared “protected classification characteristics” to outside entities like data brokers.

Kroger spokesperson Erin Rolfes said the company strives to be transparent and that, “in many cases, we have provided more information to our customers in our privacy notices than our peers.”

Brokering of general retail data is widespread. Our investigation found, though, that some websites shared sensitive clinical data with third parties even when that information would be protected at a HIPAA-covered pharmacy counter. Users attempting to schedule a vaccine appointment at Rite Aid, for example, must answer a survey first to gauge eligibility.

This investigation found that Rite Aid has sent Facebook responses to questions such as:

  • Do you have a neurological disorder such as seizures or other disorders that affect the brain or have had a disorder that resulted from a vaccine?
  • Do you have cancer, leukemia, AIDS, or any other immune system problem?
  • Are you pregnant or could you become pregnant in the next three months?

The Markup and KFF Health News documented Rite Aid sharing this data with Facebook in December 2022. In February of this year, a proposed class-action lawsuit based on similar findings was filed against the drugstore chain in California, alleging code on Rite Aid’s website sent Facebook the time of an appointment and an identifier for the appointment location, demographic information, and answers to questions about vaccination history and health conditions. Rite Aid has moved to dismiss the suit.

After the lawsuit was filed, The Markup and KFF Health News tested Rite Aid’s website again, and it was no longer sending answers to vaccination questions to Facebook.

Rite Aid isn’t the only company that sent answers to eligibility questionnaires to social media firms. Supermarkets Albertsons, Acme, and Safeway, which are owned by the same parent company, also sent answers to questions in their vaccination intake form—albeit in a format that requires cross-referencing the questionnaire’s source code to reveal the meaning of the data.

Using the Firefox web browser’s Network Monitor tool, and with the help of a patient with an active prescription at Rite Aid, KFF Health News and The Markup also found Rite Aid sending the names of patients’ specific prescriptions to Facebook. Rite Aid kept sharing prescription names even after the company stopped sharing answers to vaccination questions in response to the proposed class action (which did not mention the sharing of prescription information). Rite Aid did not respond to requests for comment, and as of June 23, the pixel was still present and sending the names of prescriptions to Facebook.

Other companies shared data about medications from other parts of their sites. Customers of Sam’s Club and Costco, for example, can search names of prescriptions on each retailer’s website to find the local pharmacy with the cheapest prices. But the two websites also sent the name of the medication the user searched for, along with the user’s IP address, to social media companies.

Many of the retailers The Markup and KFF Health News looked at did not respond to questions or declined to comment, including Costco and Sam’s Club. Albertsons said the company “continually” evaluates its privacy practices. CVS said it was compliant with “applicable laws.”

Kroger’s Rolfes wrote that the company’s “trackers disclose product information, which is not sensitive health information unless one or more inferences are made. Kroger does not make any inferences linking the product information collected or disclosed by trackers to an individual’s health condition.”

A huge regulatory challenge

Pharmacies are just one facet of a huge health care sector. But the industry as a whole has been roiled by disclosures of tracking pixels picking up sensitive clinical data.

After an investigation by The Markup in June 2022 found widespread use of trackers on hospital websites, regulatory and legal attention has homed in on the practice.

In December, the Department of Health and Human Services’ Office for Civil Rights published guidance advising health providers and insurers how pixel trackers’ use can be consistent with HIPAA. “Regulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures” of protected health information to tracking technology or other third-party vendors, according to the official bulletin. If implemented, the guidance would provide a path for the agency to regulate hospitals and other providers and fine those who don’t follow it. In an interview with an industry publication in late April, the director of the Office for Civil Rights said it would be bringing its first enforcement action for pixel use “hopefully soon.”

Lobbying groups are seeking to confine any regulatory fallout: The American Hospital Association, for example, sent a letter on May 22 to the Office for Civil Rights asking that the agency “suspend or amend” its guidance. The office, it claimed, was seeking to protect too much data.

This year the Federal Trade Commission has pursued action against companies like GoodRx, which offers prescription price comparisons, and BetterHelp, which offers online therapy, for alleged misuse of data from questionnaires and searches. The companies settled with the agency.

Health care providers have disclosed to the federal government the potential leakage of nearly 10 million patients’ data to various advertising partners, according to a review by The Markup and KFF Health News of breach notification letters and the Office for Civil Rights’ online database of breaches. That figure could be a low estimate: A new study in the journal Health Affairs found that, as of 2021, almost 99 percent of hospital websites contained tracking technologies.

One prominent law firm, BakerHostetler, is defending hospitals in 26 legal actions related to the use of tracking technologies, lawyer Paul Karlsgodt, a partner at the firm, said during a webinar this year. “We’ve seen an absolute eruption of cases,” he said.

Abortion- and pregnancy-related data is particularly sensitive and driving regulatory scrutiny. In the same webinar, Lynn Sessions, also with BakerHostetler, said the California attorney general’s office had made specific investigative requests to one of the firm’s clients about whether the client was sharing reproductive health data.

It’s unclear whether big tech companies have much interest in helping secure health data. Sessions said BakerHostetler had been trying to get Google and Meta to sign so-called business associate agreements. These agreements would bring the companies under the HIPAA regulatory umbrella, at least when handling data on behalf of hospital clients. “Both of them, at least at this juncture, have not been accommodating in doing that,” Sessions said. Google Analytics’ help page for HIPAA instructs customers to “refrain from using Google Analytics in any way that may create obligations under HIPAA for Google.”

Meta says it has tools that attempt to prevent the transfer of sensitive information like health data. In a November 2022 letter to Sen. Mark Warner (D-Va.) obtained by KFF Health News and The Markup, Meta wrote that “the filtering mechanism is designed to prevent that data from being ingested into our ads.” What’s more, the letter noted, the social media giant reaches out to companies transferring potentially sensitive data and asks them to “evaluate their implementation.”

“I remain concerned the company is too passive in allowing individual developers to determine what is considered sensitive health data that should remain private,” Warner told The Markup and KFF Health News.

Meta’s claims in its letter to Warner have been repeatedly questioned. In 2020, the company itself acknowledged to New York state regulators that the filtering system was “not yet operating with complete accuracy.”

To test the filtering system, Sven Carlsson and Sascha Granberg, reporters for SR Ekot in Sweden, set up a dummy pharmacy website in Swedish, which sent fake, but plausible, health data to Facebook to see whether the company’s filtering systems worked as stated. “We weren’t warned” by Facebook, Carlsson said in an interview with KFF Health News and The Markup.

Carlsson and Granberg’s work also found European pharmacies engaged in activities similar to what The Markup and KFF Health News have found. The reporters caught a Swedish state-owned pharmacy sending data to Facebook. And a recent investigation with The Guardian found the U.K.-based pharmacy chain LloydsPharmacy was sending sensitive data—including information about symptoms—to TikTok and Facebook.

In response to questions from KFF Health News and The Markup, Meta spokesperson Emil Vazquez said, “Advertisers should not send sensitive information about people through our Business Tools. Doing so is against our policies and we educate advertisers on properly setting up Business Tools to prevent this from occurring. Our system is designed to filter out potentially sensitive data it is able to detect.”

Meta did not respond to questions about whether it considered any of the information KFF Health News and The Markup found retailers sending to be “sensitive information,” whether any was actually filtered by the system, or whether Meta could provide metrics demonstrating the current accuracy of the system.

In response to our inquiries, Twitter sent a poop emoji, while TikTok and Pinterest said they had policies instructing advertisers not to pass on sensitive information. LinkedIn and Nextdoor did not respond.

Google spokesperson Jackie Berté said the company’s policies “prohibit businesses from using sensitive health information to target and serve ads” and that it worked to prevent such information from being used in advertising, using a “combination of algorithmic and human review” to remedy violations of its policy.

KFF Health News and The Markup presented Google with screenshots of its pixel sending the search company our browsing information when we landed on the retailers’ pages where we could purchase an HIV test and prenatal vitamins, and data showing when we added an HIV test to the cart. In response, Berté said the company had “not uncovered any evidence that the businesses in the screenshots are violating our policies.”

KFF Health News uses the Meta Pixel to collect information. The pixel may be used by third-party websites to measure web traffic and performance data and to target ads on social platforms. KFF Health News collects page usage data from news partners that opt to include our pixel tracker when they republish our articles. This data is not shared with third-party sites or social platforms and users’ personally identifiable information is not recorded or tracked, per KFF’s privacy policy. The Markup does not use a pixel tracker. You can read its full privacy policy here.

This article was co-published with The Markup, a nonprofit newsroom that investigates how powerful institutions are using technology to change our society. Sign up for The Markup’s newsletters.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

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Rural patients could suffer if the DEA restricts telehealth prescribing https://www.popsci.com/health/dea-telehealth-prescriptions-rural-patients/ Sat, 01 Jul 2023 23:00:00 +0000 https://www.popsci.com/?p=552234
Prescription bottles
Opponents argue that health care providers, not a law enforcement agency, should decide which patients need in-person appointments. Deposit Photos

The DEA wants to rein in online prescribing rules that were relaxed over the COVID-19 pandemic.

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Prescription bottles
Opponents argue that health care providers, not a law enforcement agency, should decide which patients need in-person appointments. Deposit Photos

This article originally appeared in KFF Health News.

Federal regulators want most patients to see a health care provider in person before receiving prescriptions for potentially addictive medicines through telehealth—something that hasn’t been required in more than three years.

During the covid-19 public health emergency, the Drug Enforcement Administration allowed doctors and other health care providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.

Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.

Regulators said they decided to extend the current regulations—which don’t require an in-person appointment — until November 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they’ve never met in person will have until November 11, 2024, to come into compliance with the agency’s future rules.

The public comments discuss the potential effects on a variety of patients, including people being treated for mental health disorders, opioid addiction, or attention-deficit/hyperactivity disorder. Thousands of commenters also mentioned possible impacts on rural patients.

Opponents wrote that health care providers, not a law enforcement agency, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to receive care.

Other commenters called for exemptions for specific medications and conditions.

Supporters wrote that the proposal would balance the goals of increasing access to health care and helping prevent medication misuse.

Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 residents northeast of Portland. Coogan has volunteered with hospice patients and said it’s important for very sick and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be hard to see a doctor in person if they lack transportation or are too debilitated to travel.

Coogan said she supports the DEA’s proposed rules because of a provision that could help patients who can’t travel to meet their telehealth prescriber. Instead, they could visit a local health care provider, who then could write a special referral to the telehealth prescriber. But she said accessing controlled medications would still be difficult for some rural residents.

“It could end up being a very sticky wicket” for some patients to access care, she said. “It’s not going to be easy, but it sounds like it’s doable.”

Some health care providers may hesitate to offer those referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose expertise includes addiction treatment. Kertesz said the proposed referral process is confusing and would require burdensome record-keeping.

Ateev Mehrotra, a physician and Harvard professor who has studied telehealth in rural areas, said different controlled drugs come with different risks. But overall, he finds the proposed rules too restrictive. He’s worried people who started receiving telehealth prescriptions during the pandemic would be cut off from medicine that helps them.

Mehrotra said he hasn’t seen clear evidence that every patient needs an in-person appointment before receiving controlled medicine through telehealth. He said it’s also not clear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth ones.

Mehrotra described the proposed rules as “a situation where there’s not a clear benefit, but there are substantial harms for at least some patients,” including many in rural areas.

Beverly Jordan, a family practice doctor in Alabama and a member of the state medical board, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients who receive controlled medications. Jordan prescribes such medications, including to rural patients who travel to her clinic in the small city of Enterprise.

“I think that once-a-year hurdle is probably not too big for anybody to be able to overcome, and is really a good part of patient safety,” Jordan said.

Jordan said it’s important for health care practitioners to physically examine patients to see if the exam matches how the patients describe their symptoms and whether they need any other kind of treatment.

Jordan said that, at the beginning of the pandemic, she couldn’t even view most telehealth patients on her computer. Three-fourths of her appointments were over the phone, because many rural patients have poor internet service that doesn’t support online video.

The proposed federal rules also have a special allowance for buprenorphine, which is used to treat opioid use disorder, and for most categories of non-narcotic controlled substances, such as testosterone, ketamine, and Xanax.

Providers could prescribe 30 days’ worth of these medications after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal health care practitioners would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.

Many people who work in health care were surprised by the proposed rules, Kertesz said. He said they expected the DEA to let prescribers apply for special permission to provide controlled medicine without in-person appointments. Congress ordered the agency to create such a program in 2008, but it has not done so.

Agency officials said they considered creating a version of that program for rural patients but decided against it.

Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, used to experience postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn’t think she should have to go see her telehealth provider in person to maintain her prescriptions.

“I would have to get on a plane to go to Florida. I’m not going to do that,” she said. “If the government forces me to do that, that’s wrong.”

Holiman said her primary care doctor doesn’t prescribe injectable hormones and that she shouldn’t have to find another in-person prescriber to make a referral to her Florida provider.

Holiman is one of thousands of patients who shared their opinions with the DEA. The agency also received comments from advocacy, health care, and professional groups, such as the American Medical Association.

The physicians’ organization said the in-person rule should be eliminated for most categories of controlled medication. Even telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should be exempt when medically necessary, the group said.

Some states already have laws that are stricter than the DEA’s proposed rules. Amelia Burgess said Alabama’s annual exam requirement, which went into effect last summer, burdened some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.

Burgess said hundreds of the company’s patients in Alabama couldn’t switch to in-state prescribers because many weren’t taking new patients, were too far away, or were more expensive than the telehealth service. So Burgess and her co-workers flew to Alabama and set up a clinic at a hotel in Birmingham. About 250 patients showed up, with some rural patients driving from five hours away.

Critics of the federal proposal are lobbying for exemptions for medications that can be difficult to obtain due to a lack of specialists in rural areas.

Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including in jails and prisons.

Rural areas also have shortages of mental health providers who can prescribe controlled substances for anxiety, depression, and ADHD. Patients across the country who use opioids for chronic pain have trouble finding prescribers.

It also can be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men and people with various medical conditions, such as menopause. Controlled medications are also used to treat seizures, sleep disorders, and other conditions.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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These organisms have a natural gene-editing system that could be more useful than CRISPR https://www.popsci.com/science/crispr-gene-editing-fanzor/ Thu, 29 Jun 2023 15:00:00 +0000 https://www.popsci.com/?p=552256
A Cryo-EM map of a Fanzor protein indicated by gray, yellow, light blue, and pink in complex with ωRNA indicated in purple and its target DNA in red. Non-target DNA strand in blue.
A Cryo-EM map of a Fanzor protein (gray, yellow, light blue, and pink) in complex with ωRNA (purple) and its target DNA (red). Non-target DNA strand in blue. Courtesy of the Zhang lab, Broad Institute of MIT and Harvard/McGovern Institute for Brain Research at MIT.

Fanzor proteins use RNA as a guide to precisely target DNA.

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A Cryo-EM map of a Fanzor protein indicated by gray, yellow, light blue, and pink in complex with ωRNA indicated in purple and its target DNA in red. Non-target DNA strand in blue.
A Cryo-EM map of a Fanzor protein (gray, yellow, light blue, and pink) in complex with ωRNA (purple) and its target DNA (red). Non-target DNA strand in blue. Courtesy of the Zhang lab, Broad Institute of MIT and Harvard/McGovern Institute for Brain Research at MIT.

A team of researchers has uncovered a new biological editing system that could potentially be even more precise than CRISPR gene editing. It’s based on a protein called Fanzor, and this new finding is the first programmable RNA-guided system discovered in eukaryotes. The new RNA-editing system is described in a study published June 28 in the journal Nature

[Related: CRISPR breaks ground as a one-shot treatment for a rare disease.]

Eukaryotes include fungi, plants, and animals whose cells have a nucleus. CRISPR was first discovered in organisms called prokaryotes, which are single-celled and do not have a nucleus. Discovering an editing system like this that works in eukaryotes could expand biological editing’s reach and possibly its precision.

The team shows how Fanzor proteins use RNA as a guide to precisely target DNA as well as how Fanzors can be reprogrammed to edit the genome of human cells. RNA serves multiple functions in the body, including coding, decoding, regulating, and expressing genes. The Fanzor system could also be more easily delivered to the body’s tissues and cells as therapeutics than CRISPR systems.

The study also shows that RNA-guided DNA-cutting mechanisms are present in both unicellular nucleus-lacking prokaryotes and multicellular nuclei endowed eukaryotes. 

“CRISPR-based systems are widely used and powerful because they can be easily reprogrammed to target different sites in the genome,” co-author and biochemist at the Massachusetts Institute of Technology (MIT) Feng Zhang said in a statement. “This new system is another way to make precise changes in human cells, complementing the genome editing tools we already have.”

One of the primary goals of the Zhang lab is developing genetic medicines that can modulate human cells by pinpointing specific genes and processes. They are looking beyond CRISPR to see if other RNA-programmable systems exist in the natural world. 

The team is building on a 2021 discovery of a class of RNA-programmable systems in prokaryotes called OMEGAs. That research highlighted some similarities between prokaryotic OMEGA systems and the Fanzor proteins in eukaryotes, and suggested that Fanzor enzymes could also be using an RNA-guided mechanism to target and cut DNA.

In the new study, the team isolated Fanzors from fungi, algae, and amoeba species, and a common clam called the Northern Quahog. A biochemical characterization of the Fanzor proteins showed that they are DNA-cutting endonuclease enzymes that use nearby non-coding RNAs known as ωRNAs. These  ωRNAs target particular sites in the genome, and it is the first time this mechanism has been found in eukaryotes like the clam, according to the authors.

[Related: What is a pangenome? Scientists just released their first draft.]

“These OMEGA systems are more ancestral to CRISPR and they are among the most abundant proteins on the planet, so it makes sense that they have been able to hop back and forth between prokaryotes and eukaryotes,” co-author and postdoctoral fellow at the Zhang lab Makoto Saito said in a statement

To investigate Fanzor’s potential as a future genome editing tool, the team showed that it can generate insertions and deletions at targeted genome sites within human cells like the cut and paste tool in a document. They found that the Fanzor system was initially less efficient at snipping DNA than CRISPR systems, but introducing a combination of mutations into the protein significantly increased its activity. 

According to the team, the Fanzor system can be reprogrammed to target specific genome editing technology for future research and therapeutics, just like the current CRISPR-based systems. There are also more systems like this in nature just waiting to be found.  

“Nature is amazing. There’s so much diversity,” said Zhang. “There are probably more RNA-programmable systems out there, and we’re continuing to explore and will hopefully discover more.”

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This pangolin-inspired robot can curl up into a healing ball https://www.popsci.com/technology/pangolin-robot-medicine/ Fri, 23 Jun 2023 15:00:00 +0000 https://www.popsci.com/?p=550767
Hard keratin scales inspired this tiny robot.
Hard keratin scales inspired this tiny robot. Max Planck Institute for Intelligent Systems

Pangolins are the only mammals to sport overlapping scales—a trait that could prove surprisingly useful for internal medicine.

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Hard keratin scales inspired this tiny robot.
Hard keratin scales inspired this tiny robot. Max Planck Institute for Intelligent Systems

If you don’t know what a pangolin is, then today is your lucky day. Primarily found in tropical regions of Africa and Asia, the tiny, adorable, sadly endangered creature is the only mammal known to be covered completely in overlapping scales composed of durable keratin—the same material that makes up your nails and hair. When needed, the flexible scales’ structure allows a pangolin to curl up into a defensive ball—a novel evolutionary design that recently inspired a team of engineers’ newest invention.

[Related: The Pangolin Finally Made It Onto The List Of The World’s Most Protected Animals.]

As described in a paper published on June 20 with Nature Communications, researchers at the Max Planck Institute for Intelligent Systems in Germany created a robot that could mimic a pangolins’ roly-poly resiliency. Instead of doing so for protection, however, the miniature robot uses its scaly design to quickly traverse environments while simultaneously carrying small payloads. With an added ability to heat to over 70 degrees Celsius (roughly 158 degrees Fahrenheit), the team’s barely two-centimeter-long robot shows immense promise for delivering medication within patients, as well as helping in procedures such as mitigating unwanted internal bleeding.

Endangered Species photo

The pangolin-inspired robot features a comparatively simple, two-layer design—a soft polymer layer studded in magnetic particles, and a harder exterior layer of overlapping metal scales. Exposing the robot to a low-frequency magnetic field causes it to roll into a cylindrical shape, and subsequently directing the magnetic field can influence the robot’s movement. While in this rolled shape, the team showed that their pangolin-bot can house deliverables such as medicine, and safely transport them through animal tissues and artificial organs to a desired location for release.

[Related: These 2D machines can shapeshift into moving 3D robots.]

Exposing their robot to a high-frequency magnetic field, however, offers even more avenues for potential medical treatment. In such instances, the pangolin robot’s metals heat up dramatically, providing thermal energy for situations such as treating thrombosis, cauterizing tumor tissues, or even stopping internal bleeding. “Untethered robots that can move freely, even though they are made of hard elements such as metal and can also emit heat, are rare,” reads a statement from the Planck Institute, adding that researchers’ new robot “could one day reach even the narrowest and most sensitive regions in the body in a minimally invasive and gentle way and emit heat as needed.”

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Scores of critical lab tests fall into a regulatory void. The FDA is trying to close it. https://www.popsci.com/health/fda-lab-test-regulatory-void/ Fri, 23 Jun 2023 01:00:00 +0000 https://www.popsci.com/?p=550016
The FDA’s hands-off approach to lab-developed tests traced back to a time when they were deployed at a small scale.
The FDA’s hands-off approach to lab-developed tests traced back to a time when they were deployed at a small scale. Deposit Photos

Lab-developed tests like prenatal screenings have become increasingly popular, all while escaping the bulk of federal scrutiny over marketing and accuracy.

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The FDA’s hands-off approach to lab-developed tests traced back to a time when they were deployed at a small scale.
The FDA’s hands-off approach to lab-developed tests traced back to a time when they were deployed at a small scale. Deposit Photos

This article originally published on ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.

After decades of intense debate and stalled legislation, the Food and Drug Administration has taken a critical step in overseeing a vast category of lab tests that reach patients without any federal agency checking to ensure they work the way their makers claim.

Among the tests that are not reviewed by the FDA: popular prenatal genetic screenings that ProPublica recently reported on, as well as certain cancer screenings and tests for rare diseases.

On Wednesday, a notice of the proposed rule was posted. This is the first concrete evidence that the FDA is preparing to apply its regulatory powers to these lab tests.

“A modern oversight framework that is specifically tailored to assuring tests work is critical to position ourselves for the future — whether it is preparing for the next pandemic or realizing the full potential of diagnostic innovation,” an FDA press officer said in a statement to ProPublica.

Peter Lurie, president and executive director of the Center for Science in the Public Interest, applauded the move. “It’s exciting to see the agency taking concrete steps to address this long-standing hole in the public health safety net,” he said.

The agency’s hands-off approach to lab-developed tests — which are designed, manufactured and used by a single lab — traced back to a time when they were deployed at a small scale. The idea was to spare hospital labs, for example, from the time, money and hassle of getting approval in Washington whenever they needed to create a simple test for their own patients.

Nowadays, so-called LDTs are an enormous part of the health care system, including a number of high-stakes tests made by commercial companies. Because they aren’t registered with the federal government, nobody knows how many exist. A 2021 study by Pew Charitable Trusts estimates that 12,000 labs are likely to use such tests, many of which process thousands of patient samples each day. Currently, the Centers for Medicare and Medicaid Services reviews lab operations, but it doesn’t check whether the tests themselves are clinically valid.

While these tests “play an important role in our health care system,” said the FDA press officer, the agency “is very concerned about problematic LDTs currently used in the U.S. that might not provide patients with accurate and reliable results.”

ProPublica’s investigation of prenatal genetic screenings detailed how the FDA doesn’t review the tests before they reach patients, nor does it verify marketing claims made by companies that sell them. False positives, false negatives and uncertain results about genetic anomalies have sometimes led to devastating consequences for families, the investigation found. Companies aren’t required to publicly report instances of when the test gets it wrong, and no federal agency is able to recall faulty tests. (We also made a guide to prenatal screening tests for expectant parents.)

The next step for the FDA is to publish a draft of the proposed rule, which seems likely to happen in August. It will go through a public comment period, and then the agency will develop a final rule. Both the proposed and final rules need to be cleared by the Department of Health and Human Services and the Office of Management and Budget. Experts said this process could go relatively quickly, or it could take a year or more, pushing up against a 2024 election that might change priorities in Washington.

Over the years, a large coalition of labs, professional associations and academic medical centers have argued that FDA oversight over the lab tests would be overly burdensome and inflexible — so much so that it would stunt critical innovations and limit patient access to quality health care. Opponents also express concern about the FDA’s capacity to oversee the tests.

Mary Steele Williams, executive director of the Association for Molecular Pathology, said in a statement to ProPublica that AMP is updating its proposal for an alternative approach to lab testing reform, one that doesn’t rely on the FDA. Instead, it recommends modernizing existing regulations through CMS, “which we believe to be the most effective and streamlined approach.”

Williams also said that AMP intends to continue working with other institutions to “raise our shared concerns with FDA regulation” over lab-developed tests. It remains committed, she said, “to working with Congress and other stakeholders to establish a more efficient regulatory framework that ensures high-quality patient care while continuing to foster the rapid innovation and promise of new diagnostic technologies.”

An earlier effort by the FDA to rein in LDTs came in 2014, when the agency issued draft guidance. But after facing nearly two years of stiff opposition, the agency pulled it. One of the strongest critics was the American Clinical Laboratory Association, a national trade group. It challenged the FDA’s authority over the tests by filing a citizen petition and making clear its intent to sue if necessary.

In a statement on Wednesday to ProPublica, an ACLA spokesperson said the association has long taken the position that any regulation of LDTs must be done through legislation. It should be a framework “that recognizes the essential role of clinical laboratories in advancing public health, preserving and fostering innovation and maintaining access to critical testing services,” the spokesperson said, adding: “We stand ready to provide expertise and technical assistance to Congress.”

There have been several efforts to reform lab testing through Congress over the years, and the FDA has signaled that it welcomes legislative action that would create a modern framework specifically tailored to clinical testing.

In 2022, a bipartisan bill known as the VALID Act seemed to have its best shot at passing, having gathered momentum after the scandal over fraudulent Theranos blood tests and the coronavirus pandemic. But, facing pushback, it was dropped from a must-pass bill at the end of the year. While ACLA’s spokesperson said the association worked with the bill’s sponsors to help shape it, in the end, ACLA didn’t endorse it. The act was reintroduced in the House in March.

If the FDA enacts a new rule, supporters anticipate legal challenges, said Cara Tenenbaum, a former policy adviser for the agency whose consultancy signed onto a recent letter urging it to assert oversight.

But over the past decade, the FDA tried every alternative to address what it sees as a public health problem, she said.

“All they have left is their existing device authority,” Tenenbaum said. “They’ve been backed into a corner, if you ask me.”

The FDA pushing ahead with a proposed rule, even while legislation is on the table, makes sense because “the clock is ticking on the administration,” said Lurie, a former top FDA official who worked on lab testing reform.

At the same time, he said, “the problem is long-standing and, frankly, in fact, growing. More and more products come to market every day, and very few of them get regulated.”

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Men lose Y chromosomes with age, and it might increase their risk of bladder cancer https://www.popsci.com/health/y-chromosome-bladder-cancer/ Thu, 22 Jun 2023 20:00:00 +0000 https://www.popsci.com/?p=550558
Karyotype of human chromosomes including sex chromosomes XY and XX
The typical human cell has 23 sets of chromosomes, including one set of chromosomes. The options, XY and XX, are depicted at bottom right. BSIP/Universal Images Group via Getty Images

The case of the missing Y chromosome and aggressive cancer growth is partially solved.

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Karyotype of human chromosomes including sex chromosomes XY and XX
The typical human cell has 23 sets of chromosomes, including one set of chromosomes. The options, XY and XX, are depicted at bottom right. BSIP/Universal Images Group via Getty Images

When urologic oncologist Dan Theodorescu thinks about his 25 years of research on bladder cancer, he remembers being in a flow. “When you hit something, you know in your gut that it’s really important and everything works out because you’re onto something.” His latest study, published on June 21 in the journal Nature, provides a clearer picture on why men have a greater risk for bladder cancer.

The trailblazing findings draw a clear connection between the disease and damage to the Y chromosome—the genetic structure that largely distinguishes male from female in mammals at birth. Bladder cancer is a sexually dimorphic disease with men making up a disproportionate amount of cases. In fact, men have a 1 in 28 chance of developing the cancer, compared to women, who have a 1 in 91 chance. Theodorescu, now the director of Cedars-Sinai Cancer, sought to understand why men are more prone to developing this type of cancer. Beyond risk factors like smoking cigarettes, he narrowed his decades-long search to changes in hormones and chromosomes. Previous work in the field had found that an increase in androgens, which are produced in the testes and ovaries, interferes with the body’s ability to fight off cancerous tumors. However, until this current study, few researchers focused on the role of chromosomes in bladder cancer.

As men get older, they naturally see the Y chromosome disappear in some cells. It’s a common phenomenon—at least 40 percent of men partially lose their Y chromosome by age 70. Previous research has linked that loss with several health problems, including an increase in heart failure, Alzheimer’s disease, and premature death

[Related: What is a pangenome?]

Theodorescu and his team started by studying several bladder cancer cell lines (a population of cells bred from a single common cell). They grew and isolated two sets of cells from male mice whose fathers had either kept or lost the Y chromosome. Tumor cells without a Y chromosome were more likely to exhibit aggressive growth than those with the Y chromosome. 

The next step involved pooling together 16 cancer cells from mice containing a normal Y chromosome with 16 cells missing a Y chromosome. Both cell lines had a similar growth rate. However, when they studied the same cell lines in animals, the authors noticed the tumor cells containing a Y chromosome did not grow as well as cells without a Y chromosome. 

While the cell models hint at the sex chromosome’s role in cancer development, they don’t explain why it makes bladder tumors grow more aggressively. One hypothesis is that tumor cells without a Y chromosome grow faster because they have an easier time evading a person’s immune system. To test this possibility, the researchers injected Y-positive and Y-negative cells into mice bred without an immune system. Both tumor cells grew at the same rate, unlike in the cell lines where natural defenses were intact. “This was the clue that Y-negative cells were messing with the immune system somehow,” Theodorescu says.

Another experiment used genetically engineered mice missing various pieces of their immune system and found that immune cells responsible for fighting infection, called T cells, were the ones most affected by the loss of the Y chromosome. “We compared T cells from Y-negative to Y-positive tumors and found Y-negative tumors are doing things to T cells to get them exhausted,” Theodorescu explains. “An exhausted T cell can no longer destroy the tumor.”

X chromosomes and Y chromosomes in a cell. Some of the Y chromosomes are lost, which could increase the risk of bladder cancer.
It’s common for older men to have cells that lack a Y chromosome. One potential reason why is that when cells divide, they don’t duplicate the Y chromosome because it’s small. Jared Schafer for Cedars-Sinai Cancer

The study might provide some insights on biological processes like adaptive immunity that are affected by disappearing Y chromosomes, says Chris Lau, a professor of medicine at the University of California, San Francisco who studies the human Y chromosome in his own research. “This could very well be the mechanism contributing to the disadvantage that seems to doom men with a mosaic loss of the Y chromosome in many other diseases, in which the immune system could play a role.” 

Of course, the million-dollar question is whether doctors can use this knowledge to help patients with bladder cancer. One option includes immune checkpoint inhibitors. This common form of immunotherapy blocks the receptors that tumors use to send signals that confuse T cells. It also teaches T cells how to recognize cancer cells. When Theodorescu’s team administered immune checkpoint inhibitors to mice, they found those with Y-negative tumors responded better to treatment than Y-positive tumors.

[Related: A ‘living’ cancer drug helped two patients stay disease-free for a decade]

A new project Theodorescu and his colleagues are currently working on is seeing how many genes on the X chromosome are duplicates of genes found in the Y chromosome, also known as paralogs. Any mutations of these paralogs would cause a loss of gene function that could contribute to immune evasion in women, potentially adding to the risk of bladder cancer. Another issue the team is investigating is what happens to men who lose their Y chromosome and have mutations in Y-related genes on the X chromosome. “The loss may give you a worse cancer, but the response to immunotherapy could be even better,” Theodorescu notes. 

If all goes well, Theodorescu says he plans to use the data from his recent work to create a test that would predict a person’s response to immunotherapy for any cancer. Additionally, the findings could help enhance immunotherapy and make it more effective against Y-negative tumors. Theodorescu is also not discounting the possibility of boosting immune response against other types of cancer. “If this pans out,” he says, “we may be in a situation where we could use this platform to discover combination therapies that could potentially cure a significant number of patients than checkpoint inhibitor therapy alone.”

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Families flee states amid restrictions on gender-affirming health care https://www.popsci.com/health/transgender-gender-affirming-health-care-restrictions/ Thu, 22 Jun 2023 01:00:00 +0000 https://www.popsci.com/?p=549995
back of head, ponytail
New restrictions on health care and the possibility of more in the future are forcing individuals and families to relocate to other neighborhoods, cities, or even states. DepositPhotos

Missouri, Florida, and Texas are among at least 20 states that have limited components of gender-affirming health care for trans youth.

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back of head, ponytail
New restrictions on health care and the possibility of more in the future are forcing individuals and families to relocate to other neighborhoods, cities, or even states. DepositPhotos

This article was originally published on KFF Health News.

Hal Dempsey wanted to “escape Missouri.” Arlo Dennis is “fleeing Florida.” The Tillison family “can’t stay in Texas.”

They are part of a new migration of Americans who are uprooting their lives in response to a raft of legislation across the country restricting health care for transgender people.

Missouri, Florida, and Texas are among at least 20 states that have limited components of gender-affirming health care for trans youth. Those three states are also among the states that prevent Medicaid — the public health insurance for people with low incomes — from paying for key aspects of such care for patients of all ages.

More than a quarter of trans adults surveyed by KFF and The Washington Post late last year said they had moved to a different neighborhood, city, or state to find more acceptance. Now, new restrictions on health care and the possibility of more in the future provide additional motivation.

Many are heading to places that are passing laws to support care for trans people, making those states appealing sanctuaries. California, for example, passed a law last fall to protect those receiving or providing gender-affirming care from prosecution. And now, California providers are getting more calls from people seeking to relocate there to prevent disruptions to their care, said Scott Nass, a family physician and expert on transgender care based in the state.

But the influx of patients presents a challenge, Nass said, “because the system that exists, it can’t handle all the refugees that potentially are out there.”

In Florida, the legislative targeting of trans people and their health care has persuaded Arlo Dennis, 35, that it is time to uproot their family of five from the Orlando area, where they’ve lived for more than a decade. They plan to move to Maryland.

Dennis, who uses they/them pronouns, no longer has access to hormone replacement therapy after Florida’s Medicaid program stopped covering transition-related care in late August under the claim that the treatments are experimental and lack evidence of being effective. Dennis said they ran out of their medication in January.

“It’s definitely led to my mental health having struggles and my physical health having struggles,” Dennis said.

Moving to Maryland will take resources Dennis said their family does not have. They launched a GoFundMe campaign in April and have raised more than $5,600, most of it from strangers, Dennis said. Now the family, which includes three adults and two children, plans to leave Florida in July. The decision wasn’t easy, Dennis said, but they felt like they had no choice.

“I’m OK if my neighbor doesn’t agree with how I’m living my life,” Dennis said. “But this was literally outlawing my existence and making my access to health care impossible.”

Mitch and Tiffany Tillison decided they needed to leave Texas after the state’s Republicans made anti-trans policies for youth central to their legislative agenda. Their 12-year-old came out as trans about two years ago. They asked for only her middle name, Rebecca, to be published because they fear for her safety due to threats of violence against trans people.

This year, the Texas Legislature passed a law limiting gender-affirming health care for youth under 18. It specifically bans physical care, but local LGBTQ+ advocates say recent crackdowns also have had a chilling effect on the availability of mental health therapy for trans people.

While the Tillisons declined to specify what treatment, if any, their daughter is getting, they said they reserve the right, as her parents, to provide the care their daughter needs — and that Texas has taken away that right. That, plus increasing threats of violence in their community, particularly in the wake of the May 6 mass shooting by a professed neo-Nazi at Allen Premium Outlets, about 20 miles from their home in the Dallas suburbs, caused the family to decide to move to Washington state.

“I’ve kept her safe,” said Tiffany Tillison, adding that she often thinks back to the moment her daughter came out to her during a long, late drive home from a daylong soccer tournament. “It’s my job to continue to keep her safe. My love is unending, unconditional.”

For her part, Rebecca is pragmatic about the move planned for July: “It’s sad, but it is what we have to do,” she said.

A close call on losing key medical care in Missouri also pushed some trans people to rethink living there. In April, Missouri Attorney General Andrew Bailey issued an emergency rule seeking to limit access to transition-related surgery and cross-sex hormones for all ages, and restrict puberty-blocking drugs, which pause puberty but don’t alter gender characteristics. The next day, Dempsey, 24, who uses they/them pronouns, launched a GoFundMe fundraiser for themself and their two partners to leave Springfield, Missouri.

“We are three trans individuals who all depend on the Hormone Replacement Therapy and gender affirming care that is soon to be prohibitively limited,” Dempsey wrote in the fundraising appeal, adding they wanted to “escape Missouri when our lease is up at the end of May.”

Dempsey said they also got a prescription for a three-month supply of hormone therapy from their doctor in Springfield to tide them over until the move.

Bailey withdrew his rule after the state legislature in May restricted new access to such treatments for minors, but not adults like Dempsey and their partners. Still, Dempsey said their futures in Missouri didn’t look promising.

Neighboring Illinois was an obvious place to move; the legislature there passed a law in January that requires state-regulated insurance plans to cover gender-affirming health care at no extra cost. Where exactly was a bigger question. Chicago and its suburbs seemed too expensive. The partners wanted a progressive community similar in size and cost of living to the city they were leaving. They were looking for a Springfield in Illinois.

“But not Springfield, Illinois,” Dempsey quipped.

Gwendolyn Schwarz, 23, had also hoped to stay in Springfield, Missouri, her hometown, where she had recently graduated from Missouri State University with a degree in film and media studies. She had planned to continue her education in a graduate program at the university and, within the next year, get transition-related surgery, which can take a few months of recovery.

But her plans changed as Bailey’s rule stirred fear and confusion.

“I don’t want to be stuck and temporarily disabled in a state that doesn’t see my humanity,” Schwarz said.

She and a group of friends are planning to move west to Nevada, where state lawmakers have approved a measure that requires Medicaid to cover gender-affirming treatment for trans patients.

Schwarz said she hopes moving from Missouri to Nevada’s capital, Carson City, will allow her to continue living her life without fear and eventually get the surgery she wants.

Dempsey and their partners settled on Moline, Illinois, as the place to move. All three had to quit their jobs to relocate, but they have raised $3,000 on GoFundMe, more than enough to put a deposit down on an apartment.

On May 31, the partners packed the belongings they hadn’t sold and made the 400-mile drive to their new home.

Since then, Dempsey has already been able to see a medical provider at a clinic in Moline that caters to the LGBTQ+ community — and has gotten a new prescription for hormone therapy.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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New medical policy finally address the limitations and flaws of BMI https://www.popsci.com/health/body-mass-index-obesity-medicine/ Wed, 21 Jun 2023 00:00:00 +0000 https://www.popsci.com/?p=549713
An old scale used for calculating body weight.
BMI is calculated by dividing a person’s weight by their height squared. Deposit Photos

'No single number gives a complete assessment of patient health.'

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An old scale used for calculating body weight.
BMI is calculated by dividing a person’s weight by their height squared. Deposit Photos

Earlier this month, the American Medical Association adopted a new policy on the use of body mass index (BMI), which has been widely used since 1972, in clinical settings. The AMA suggests that going forward, physicians should also consider factors like the fat stored in the abdominal cavity and around the organs (visceral fat), a body adiposity index that uses hip circumference and height, along with genetics, metabolic factors, and the percentage of fat, bone, and muscle in a patient’s body.

[Related: There are better ways to measure body fat than BMI.]

BMI has been criticized by patients and some physicians for its inability to distinguish muscle from fat among numerous other factors, making it a flawed indicator of how much body fat a person actually has. Athletes with large amounts of lean muscle can end up labeled as “overweight” since muscle weighs more than fat, and fat distribution, not just quantity, has an effect on people’s health. 

BMI is also steeped in racial exclusion in medicine and “historical harm.” It is based on a roughly 200 year old calculation called the the Quetelet index, which was created by Adolphe Quetelet, a Belgian mathematician and statistician looking to use height and body weight to characterize “normal man.”

“The new policy was part of the AMA Council on Science and Public Health report which evaluated the problematic history with BMI and explored alternatives,” the AMA wrote in a statement on June 14. “BMI is based primarily on data collected from previous generations of non-Hispanic white populations.” 

BMI is calculated by dividing a person’s weight by their height squared. A BMI of less than 18.5 is  considered underweight, whereas a “healthy weight” is up to 24.9. Overweight is considered 25 to 29.9 a patient is considered obese with a BMI of 30 and above.

The AMA said that BMI “loses predictability when applied on the individual level” compared to being a general way to assess correlation of body fat. The new policy addresses BMI’s known limitations, noting that it doesn’t differentiate between lean and fat body mass or account for differences between racial and ethnic groups, age, or biological sex. 

A report supporting this recent policy change cites that women tend to have more body fat than men and Asian people have more body fat than white people—both are examples of differences between demographic groups. The BMI also does not take into account where body fat is distributed on the body, the authors say. 

Carrying more visceral fat (or having a more “apple-shaped” body) is considered a greater risk for heart disease and type-2 diabetes than being “pear-shaped” (carrying weight around the thighs, legs, and butt). Different groups also tend to carry this weight differently.

[Related: Why is it more dangerous to have belly fat?]

The AMA also notes that BMI is used because it is an inexpensive tool. It can be used to determine insurance rates, determine qualifications for surgery, and can even be a factor in adopting a child

“Health care professionals use a variety of types of numerical information to assess patient health, with common ones being blood pressure, blood glucose, body mass index (BMI) etc,” Wajahat Mehal, an MD and Director of the Yale Metabolic Health and Weight Loss Program at Yale Medicine told PopSci. “No single number gives a complete assessment of patient health and the recent AMA guidelines highlight the usefulness and limitations of using the BMI. These are excellent guidelines and emphasize the need to use a variety of numerical indicators, in addition to BMI, to obtain a complete assessment of patient health.”

Some doctors say that it will be difficult to completely erase BMI from your next physical exam. 

“There are other ways of assessing body fat,” Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine, told CNN. However, “they’re not as easy and as inexpensive as BMI. I’m not sure we can throw out BMI until we have other measures that are as easy to use,” he said, adding that BMI should not be a gatekeeper for patients seeking weight loss treatment. 

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Primary care doctors are fed up and burnt out https://www.popsci.com/health/burnout-primary-care-doctor-mental-health/ Mon, 12 Jun 2023 01:00:00 +0000 https://www.popsci.com/?p=547400
Stressed doctor with fluorography
Providers’ collective exhaustion is a crisis kept hidden by design. DepositPhotos

'Why go into primary care when you can make twice the money doing something with half the stress?'

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Stressed doctor with fluorography
Providers’ collective exhaustion is a crisis kept hidden by design. DepositPhotos

This article originally appeared on KFF Health News.

If you or someone you know may be experiencing a mental health crisis, contact the 988 Suicide & Crisis Lifeline by dialing “988,” or the Crisis Text Line by texting “HOME” to 741741.

CHARLESTON, S.C. — Melanie Gray Miller, a 30-year-old physician, wiped away tears as she described the isolation she felt after losing a beloved patient.

“It was at the end of a night shift, when it seems like bad things always happen,” said Miller, who is training to become a pediatrician.

The infant had been sick for months in the Medical University of South Carolina’s pediatric intensive care unit and the possibility that he might not improve was obvious, Miller recalled during an April meeting with physicians and hospital administrators. But the suddenness of his death still caught her off guard.

“I have family and friends that I talk to about things,” she said. “But no one truly understands.”

Doctors don’t typically take time to grieve at work. But during that recent meeting, Miller and her colleagues opened up about the insomnia, emotional exhaustion, trauma, and burnout they experienced from their time in the pediatric ICU.

“This is not a normal place,” Grant Goodrich, the hospital system’s director of ethics, said to the group, acknowledging an occupational hazard the industry often downplays. “Most people don’t see kids die.”

The recurring conversation, scheduled for early-career doctors coming off monthlong pediatric ICU rotations, is one way the hospital helps staffers cope with stress, according to Alyssa Rheingold, a licensed clinical psychologist who leads its resiliency program.

“Often the focus is to teach somebody how to do yoga and take a bath,” she said. “That’s not at all what well-being is about.”

Burnout in the health care industry is a widespread problem that long predates the covid-19 pandemic, though the chaos introduced by the coronavirus’s spread made things worse, physicians and psychologists said. Health systems across the country are trying to boost morale and keep clinicians from quitting or retiring early, but the stakes are higher than workforce shortages.

Rates of physician suicide, partly fueled by burnout, have been a concern for decades. And while burnout occurs across medical specialties, some studies have shown that primary care doctors, such as pediatricians and family physicians, may run a higher risk.

“Why go into primary care when you can make twice the money doing something with half the stress?” said Daniel Crummett, a retired primary care doctor who lives in North Carolina. “I don’t know why anyone would go into primary care.”

Doctors say they are fed up with demands imposed by hospital administrators and health insurance companies, and they’re concerned about the notoriously grueling shifts assigned to medical residents during the early years of their careers. A long-standing stigma keeps physicians from prioritizing their own mental health, while their jobs require them to routinely grapple with death, grief, and trauma. The culture of medicine encourages them to simply bear it.

“Resiliency is a cringe word for me,” Miller said. “In medicine, we’re just expected to be resilient 24/7. I don’t love that culture.”

And though the pipeline of physicians entering the profession is strong, the ranks of doctors in the U.S. aren’t growing fast enough to meet future demand, according to the American Medical Association. That’s why burnout exacerbates workforce shortages and, if it continues, may limit the ability of some patients to access even basic care. A 2021 report published by the Association of American Medical Colleges projects the U.S. will be short as many as 48,000 primary care physicians by 2034, a higher number than any other single medical specialty.

A survey published last year by The Physicians Foundation, a nonprofit focused on improving health care, found more than half of the 1,501 responding doctors didn’t have positive feelings about the current or future state of the medical profession. More than 20% said they wanted to retire within a year.

Similarly, in a 2022 AMA survey of 11,000 doctors and other medical professionals, more than half reported feeling burned out and indicated they were experiencing a great deal of stress.

Those numbers appear to be even higher in primary care. Even before the pandemic, 70% of primary care providers and 89% of primary care residents reported feelings of burnout.

“Everyone in health care feels overworked,” said Gregg Coodley, a primary care physician in Portland, Oregon, and author of the 2022 book “Patients in Peril: The Demise of Primary Care in America.”

“I’m not saying there aren’t issues for other specialists, too, but in primary care, it’s the worst problem,” he said.

The high level of student debt most medical school graduates carry, combined with salaries more than four times as high as the average, deter many physicians from quitting medicine midcareer. Even primary care doctors, whose salaries are among the lowest of all medical specialties, are paid significantly more than the average American worker. That’s why, instead of leaving the profession in their 30s or 40s, doctors often stay in their jobs but retire early.

“We go into medicine to help people, to take care of people, to do good in the world,” said Crummett, who retired from the Duke University hospital system in 2020 when he turned 65.

Crummett said he would have enjoyed working until he was 70, if not for the bureaucratic burdens of practicing medicine, including needing to get prior authorization from insurance companies before providing care, navigating cumbersome electronic health record platforms, and logging hours of administrative work outside the exam room.

“I enjoyed seeing patients. I really enjoyed my co-workers,” he said. “The administration was certainly a major factor in burnout.”

Jean Antonucci, a primary care doctor in rural Maine who retired from full-time work at 66, said she, too, would have kept working if not for the hassle of dealing with hospital administrators and insurance companies.

Once, Antonucci said, she had to call an insurance company — by landline and cellphone simultaneously, with one phone on each ear — to get prior authorization to conduct a CT scan, while her patient in need of an appendectomy waited in pain. The hospital wouldn’t conduct the scan without insurance approval.

“It was just infuriating,” said Antonucci, who now practices medicine only one day a week. “I could have kept working. I just got tired.”

Providers’ collective exhaustion is a crisis kept hidden by design, said Whitney Marvin, a pediatrician who works in the pediatric ICU at the Medical University of South Carolina. She said hospital culture implicitly teaches doctors to tamp down their emotions and to “keep moving.”

“I’m not supposed to be weak, and I’m not supposed to cry, and I’m not supposed to have all these emotions, because then maybe I’m not good enough at my job,” said Marvin, describing the way doctors have historically thought about their mental health.

This mentality prevents many doctors from seeking the help they need, which can lead to burnout — and much worse. An estimated 300 physicians die by suicide every year, according to the American Foundation for Suicide Prevention. The problem is particularly pronounced among female physicians, who die by suicide at a significantly higher rate than women in other professions.

A March report from Medscape found, of more than 9,000 doctors surveyed, 9% of male physicians and 11% of female physicians said they have had suicidal thoughts. But the problem isn’t new, the report noted. Elevated rates of suicide among physicians have been documented for 150 years.

“Ironically, it’s happening to a group of people who should have the easiest access to mental health care,” said Gary Price, a Connecticut surgeon and president of The Physicians Foundation.

But the reluctance to seek help isn’t unfounded, said Corey Feist, president of the Dr. Lorna Breen Heroes’ Foundation.

“There’s something known in residency as the ‘silent curriculum,’” Feist said in describing an often-unspoken understanding among doctors that seeking mental health treatment could jeopardize their livelihood.

Feist’s sister-in-law, emergency room physician Lorna Breen, died by suicide during the early months of the pandemic. Breen sought inpatient treatment for mental health once, Feist said, but feared that her medical license could be revoked for doing so.

The foundation works to change laws across the country to prohibit medical boards and hospitals from asking doctors invasive mental health questions on employment or license applications.

“These people need to be taken care of by us, because really, no one’s looking out for them,” Feist said.

In Charleston, psychologists are made available to physicians during group meetings like the one Miller attended, as part of the resiliency program.

But fixing the burnout problem also requires a cultural change, especially among older physicians.

“They had it worse and we know that. But it’s still not good,” Miller said. “Until that changes, we’re just going to continue burning out physicians within the first three years of their career.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

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Why scientists have a hard time getting money to study the root causes of outbreaks https://www.popsci.com/health/money-to-study-outbreak-causes/ Wed, 07 Jun 2023 01:00:00 +0000 https://www.popsci.com/?p=546172
Understanding what conditions prime pathogens to leap from animals to people could help us prevent outbreaks.
Understanding what conditions prime pathogens to leap from animals to people could help us prevent outbreaks. DepositPhotos

Government and groups that award grants to scientists favor research that’s high tech and treatment oriented rather than studies that seek to understand why contagions leap from animals to people.

The post Why scientists have a hard time getting money to study the root causes of outbreaks appeared first on Popular Science.

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Understanding what conditions prime pathogens to leap from animals to people could help us prevent outbreaks.
Understanding what conditions prime pathogens to leap from animals to people could help us prevent outbreaks. DepositPhotos

This article was originally featured on ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.

The outbreaks keep coming.

Mpox, the virus formerly known as monkeypox, last year crossed borders with unprecedented speed to infect nearly 90,000 people. In the past year, Ebola killed at least 55 in Uganda, and a related, equally deadly virus called Marburg emerged in two countries that have never seen it before. Now, scientists are worried that a dangerous bird flu that’s been jumping to mammals could mutate and spread among humans.

These viruses all came from wildlife. Understanding what conditions prime pathogens to leap from animals to people could help us prevent outbreaks. After COVID-19 showed the world the devastation a pandemic can bring, you’d think this type of research would be among the hottest areas of science, with funders lined up far and wide.

That’s not the case. As ProPublica has shown in a series of stories this year, global health authorities focus far more attention and money on containing outbreaks once they begin rather than preventing them from starting in the first place. This mindset has hindered scientists who study the complex dynamics that drive what’s known as spillover, the moment a pathogen leaps from one species to another.

Australian researcher Peggy Eby and her colleagues have shown that it is possible to predict when spillovers are going to happen by closely tracking bats that spread contagion and patiently observing changes that shape their world. This groundbreaking research on the often-fatal Hendra virus relied on decades of Eby’s field work, some of which she did without pay. Early on, one government funder told her that the project she proposed wasn’t a “sufficiently important contribution.” She and her colleagues had to cobble together a mishmash of different grants and keep impatient funders happy. Their work, published late last year in the journal Nature, highlights ways to intervene and potentially prevent outbreaks.

Scientists want to unlock similar mysteries involving other infectious diseases, but research like this is difficult to do and even more difficult to fund. Here are some of the obstacles that stand in the way:

High-tech research overshadows old-school field work.

Government and scientific funding organizations typically reward cutting-edge technologies, such as using machine learning to build models. But those are only as good as the information fed into them — data that someone like Eby has to collect through painstaking groundwork. Many of Eby’s most important insights have come from visiting and revisiting bat roosts over many years, and there was nothing high-tech or novel about her method: a keen eye, a pair of binoculars, a pen and a notebook.

Funders prize novelty over exploring existing theories.

Some funders prioritize totally new ideas. Eby and her colleagues have found that bats shed more Hendra virus after being stressed by food shortages, which have increased as people cut down native trees that once provided the nectar the bats like to eat. Sarah Olson, director of health research at the Wildlife Conservation Society, has long wanted to conduct similar research on bats suspected of carrying the Ebola virus in the Republic of Congo. Developers have cleared swaths of forest in recent years to build roads and housing, and Olson wants to understand how that’s affected these bats.

Olson has applied for grant after grant since 2015 but has struggled to get sufficient funding. Even before she applied, an employee at the National Science Foundation told her the study wouldn’t be novel enough because she wasn’t exploring an entirely new theory. Rather than strengthening her case, Eby and her colleagues’ prior work weakened Olsen’s chances. A spokesperson for the National Science Foundation said the agency could not comment on specific grants. Speaking generally, the spokesperson wrote, “The most competitive proposals are those that advance broad, conceptual knowledge that reaches beyond the specific system under study.”

Olson has lined up Congolese researchers who are willing to collaborate. “We can do it,” she said. “It’s just a matter of getting funding and the interest.”

Funders’ focus is often too narrow.

If you want to predict and prevent an outbreak, you have to answer big questions: What causes spillover? Why this year and not another? How does a changing environment influence animals and their interactions with humans? Experts across disciplines are needed, but cross-disciplinary vision is hard to find among many of the most prominent funding agencies.

The National Institute of Allergy and Infectious Diseases, for example, focuses on research to develop treatments, vaccines and diagnostic tests and to understand viruses at the molecular level. Conservation and environment-focused grants rarely include human health in their scope.

Olson pitched her study on Congolese bats to the National Institutes of Health. She got rejected, she said, because grant reviewers said that it wasn’t clear how the bat results could be linked to human infections. An NIH spokesperson said the agency doesn’t comment on specific grants, adding, “It is incumbent on investigators who want to study overlapping interests of animal and human health to clearly describe the relevance of their proposed research to the advancement of human health.”

Eby and her colleague, Dr. Raina Plowright, a professor of disease ecology at Cornell University, smacked into these same silos when their applications for grant after grant were shot down. An animal foundation, for instance, said it wasn’t within its mandate to care about diseases that jumped to humans.

Thomas Gillespie, a professor of environmental sciences at Emory University, wanted to investigate whether stress affects when cave-dwelling bats in Costa Rica shed leptospirosis, a type of bacteria that can be deadly to humans. A joint program from the National Science Foundation and the NIH said the project was “too ambitious,” he recalled. Gillespie and his colleagues tried for a different NIH grant, but reviewers complained the focus was too much on animals and not enough on humans, he said. In the end, he and his colleagues stitched together funding from a museum, a nonprofit and private foundations, but they had to scale back the project to stay within budget.

Long-term research doesn’t fit into short-term grants.

Research grants typically last two to three years, which is not enough time to observe how climate change, food shortages, habitat loss and deforestation are affecting animal behavior. For their Hendra research, Eby and her colleagues analyzed data that spanned 25 years. To support that long-term data collection, Eby sometimes took on contract work, such as helping local governments figure out how to deal with bats that people in the area considered a nuisance.

Plowright won a grant from an arm of the Department of Defense, but it only allowed two years for collecting field data. “They needed us to wrap things up and show results to justify our funding,” Plowright said. That schedule is the norm, not an outlier, in science.

Some key programs are one-offs.

It’s not just that grants are short term. Some of the rare grant-giving initiatives that focus on prevention don’t last long either.

The Hendra virus researchers received some of their biggest financial support from a Defense Advanced Research Projects Agency program that was unique in its scope and vision. Called Preventing Emerging Pathogenic Threats, the program sought to understand the reasons contagions spread from animals to people. The ultimate goal was to devise strategies to protect U.S. troops in places where there are endemic and emerging infectious diseases, according to Kristen Jordan, the deputy director for the DARPA Biological Technologies Office. Unlike many others, this program was designed to support multidisciplinary research and was squarely focused on prevention. In 2018, it funded five projects, including the Hendra virus research.

But that’s it. After five years, the program is wrapping up for good. “We look to our government partners to pick up the pieces, if they so desire,” Jordan said. “We are ready for the next hard problem; there are many we need to address.”

Similarly, a program at the NIH called the Centers for Research in Emerging Infectious Diseases is among the few that fund scientists across disciplines who are trying to understand spillover. Established in 2020, the program plans to award $82 million over five years. That’s not as much as it sounds. Consider that the NIH receives more than $3 billion annually for HIV and AIDS research. Jean Patterson, the scientist who helps oversee the program, said that when the five years is up, she and her team have to make the case to NIH leaders that their program should continue or it will be dropped.

Money is scarce, even for solutions.

When researchers uncover ways to prevent outbreaks, getting funders to implement those solutions is no sure bet. Emily Gurley, an infectious disease epidemiologist at Johns Hopkins University, succeeded in winning government funding to piece together how the Nipah virus jumped from bats to people in Bangladesh. She and her colleagues figured out a way to interrupt the transmission of Nipah, the virus used as the model for the disease in the movie “Contagion.”

Gurley and her team used infrared cameras to determine that bats were drinking sap that residents were collecting in pots attached to date palm trees. People caught Nipah when they drank sap contaminated by infected bats.

Across multiple studies, Gurley and her colleagues showed that bamboo skirts covering the pots were cheap and easy to make, accepted by local sap collectors and effective at keeping out bats. With a proven solution in hand, Gurley wanted to roll this out in other parts of Bangladesh where bats spread Nipah, but she said no U.S. or international agency would step up to fund that work. The Bangladeshi government tells people not to drink raw sap, but this is a long-standing tradition that may be hard to eliminate.

Gillespie, the Emory professor, said that government and private scientific funding groups need to prioritize research into prevention, so we can learn how best to head off deforestation, habitat loss and other causes of spillover. “We have to do something now, or we’ll end up in an era of pandemics,” he warned.

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This bee’s tiny backpack could one day monitor human hearts https://www.popsci.com/technology/bee-medical-sensor/ Fri, 02 Jun 2023 15:30:00 +0000 https://www.popsci.com/?p=545568
Honeybee with medical sensor attached to back
The tiny new sensor could one day find its way into a variety of medical monitoring methods. PJURGEN RAHMER AND INGO SCHMALE/PHILIPS RESEARCH HAMBURG

At a millimeter wide, the device could monitor blood pressure or tumors seamlessly in patients.

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Honeybee with medical sensor attached to back
The tiny new sensor could one day find its way into a variety of medical monitoring methods. PJURGEN RAHMER AND INGO SCHMALE/PHILIPS RESEARCH HAMBURG

Testing the viability of an injectable medical sensor by first strapping it to a bee’s back like a tiny bee backpack may not initially make the most sense. But are you really going to question researchers’ motives for something that looks so cute?

As detailed in a paper published earlier this week in Science, a team at Philips Research in Hamburg, Germany recently designed a 1-millimeter-wide sensor employing two opposing magneto-mechanical resonators (MMRs) within a cylindrical casing. They then attached the sensor to a honeybee just above its wings, and released the insect into a small enclosure featuring a variety of flowers to hop between.

Researchers wirelessly checked the sensor’s conditions by remotely stimulating the MMRs with pulses of current from electromagnetic coils. How much the magnets oscillated, the distance between them, as well as how much they contracted and expanded subsequently helped the team measure its location, pressure, and temperature. MMRs are generally far more sensitive than other, similar radiofrequency trackers, and are thus also capable of three-dimensional spatial tracking. As such, researchers could track the bee’s flight patterns, as well as its positioning as it walked upside down across the case’s ceiling.

[Related: Neuralink human brain-computer implant trials finally get FDA approval.]

The sensor didn’t only stay strapped to its bee test subject—researchers also experimented with using their device to three-dimensionally chart its path through a lengthy, twisting tube simulating a gastrointestinal tract. And if that weren’t enough, the sensor also helped navigate a biopsy needle in a simulated environment, as well as recorded the paths of a writing marker tracing continents’ outlines on a globe.

Although the team estimates their device is still between 5 and 8 years away from becoming available to the public, they believe that the sensor could prove extremely useful in a variety of medical settings. For example, such a sensor could one day be implanted directly in a patient’s heart to measure arterial blood pressure, or within tumors to observe their progress or eradication. A safe, ingestible pill to assess GI tract health is also easily foreseeable for such a small sensor.

That’s all well and good, but would all be worth it alone to see more bees buzzing around gardens with miniature fanny packs.

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Meningitis shot that fights 5 different strains shows promise in latest trial https://www.popsci.com/health/meningitis-vaccine-trial/ Wed, 24 May 2023 22:00:00 +0000 https://www.popsci.com/?p=543111
Meningococcal bacteria under a microscope. According to the World Health Organization, meningitis caused an estimated 25,000 deaths in 2019.
According to the World Health Organization, meningitis caused an estimated 25,000 deaths in 2019. European Centre for Disease Prevention and Control

The vaccine could be a useful tool in countering meningitis in children and young adults.

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Meningococcal bacteria under a microscope. According to the World Health Organization, meningitis caused an estimated 25,000 deaths in 2019.
According to the World Health Organization, meningitis caused an estimated 25,000 deaths in 2019. European Centre for Disease Prevention and Control

A phase 3 trial found that a new meningococcal disease vaccine is safe and effective and also induces a strong immune response across five strains of meningococcal bacteria. The results were published May 24 in the New England Journal of Medicine. The vaccine could be a useful tool in eliminating meningitis in African countries including parts of Senegal, Mali, and Ethiopia.

[Related: A once-forgotten antibiotic could be a new weapon against drug-resistant infections.]

Meningococcal disease is a cause of meningitis and blood poisoning. According to the World Health Organization, meningitis caused an estimated 25,000 deaths in 2019. While vaccines are readily available in wealthier countries, vaccinating the more vulnerable regions has been a challenge, largely due to cost. Developing affordable vaccines that provide broad coverage against meningococcal disease strains is a key part of the World Health Organization’s Defeating Meningitis by 2030 Global Roadmap.

The trial compared the immune response generated by a new pentavalent, or 5-in-1, vaccine  called NmCV-5 against that of the licensed quadrivalent, or 4-in-1, MenACWY-D vaccine. The participants included 1,800 healthy two to 29-year-olds in Mali and The Gambia in western Africa. The vaccinations occurred in June 2021, and the trial didn’t find any safety concerns with NmCV-5. 

After 28 days, the immune responses generated by one dose of NmCV-5 were generally higher than those generated by the 4-in-1 vaccine across all age groups. The 5-in-1 vaccine also induced a strong immune response across meningococcal bacteria strains A, C, W, and Y and the emerging X strain. Currently, there is no licensed vaccine against the X strain, which may be the cause of meningitis epidemics in sub-Saharan Africa.

“Meningitis is a deadly disease with the ability to spread like wildfire in the event of an outbreak, this affects all ages most especially within the meningitis belt region,” study co-author Ama Umesi said in a statement. Umesi is a clinical trial coordinator and clinician from the Medical Research Council’s Unit The Gambia at the London School of Hygiene & Tropical Medicine. 

“Epidemic preparedness is the way forward in providing available, affordable and accessible vaccines relevant to regions prone to meningitis outbreaks. Having meningitis vaccines should be a public health priority to prevent catastrophic outcomes during an outbreak and would be a game changer in the fight against meningitis,” Umensi said.

Issues with supply and affordability have limited the use of 4-in-1 meningococcal vaccines across a portion of sub-Saharan Africa called the meningitis belt. This region is at high-risk of epidemics of both meningococcal and pneumococcal meningitis. The NmCV-5 vaccine was developed by the Serum Institute of India and PATH, the global division of the Bill & Melinda Gates foundation. It follows the successful Meningitis Vaccine Project that developed an effective meningococcal A vaccine called MenAfriVac.

[Related: Ghana is the first country to approve Oxford’s malaria vaccine.]

According to the study, the new NmCV-5 vaccine can be made available at lower cost than existing 4-in-1 vaccines with more cost-effective production methods. The trial was designed to provide the World Health Organization with the evidence it needs to license the new vaccine for future epidemic control.

“As a researcher in the continent, I am hopeful that relevant vaccines for the common strains within the meningitis belt region will be readily available for timely interventions due to the collaboration and teamwork of multicentre trials like ours,” Umesi said. “Together we can defeat meningitis,” Umesi said. 

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Here’s what really happens when you pull a muscle https://www.popsci.com/what-makes-muscle-pull/ Wed, 11 Aug 2021 12:11:00 +0000 https://www.popsci.com/uncategorized/what-makes-muscle-pull/
A person wearing running shorts holding their thigh on a beach, potentially wondering what happens when you pull a muscle, because they probably just did.
Treatments for minor pulls include ice packs and elevation at home, but full tears might require surgery. Depositphotos

Stretching can prevent muscle strains, and rest helps them heal.

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A person wearing running shorts holding their thigh on a beach, potentially wondering what happens when you pull a muscle, because they probably just did.
Treatments for minor pulls include ice packs and elevation at home, but full tears might require surgery. Depositphotos

Joel Cramer was at the pool with his kids when another dad, competing in a big splash contest, got up onto the diving board. He bounced up once, and when he landed on the board for the second time, his quadriceps muscle tore. “It rolled up his leg and balled up near the top of his thigh,” says Cramer, a professor of exercise physiology at the University of Nebraska. “[It was] like rolling up a window shade.”

That’s an extreme (and extremely rare) example of a muscle strain, a common injury that happens to high school soccer stars, recreational runners, and middle-aged racquetball players alike. “Strain” is the medical term for the condition, though it’s colloquially known as a pulled muscle. The term is a catch-all that covers everything from a small twinge to a full-on rupture.

What is a pulled muscle?

The human body contains three different types of muscles: cardiac, skeletal, and visceral (or smooth). Of those, skeletal are the only ones that we have control over—and thus, the ones that we can injure. Skeletal muscles are made of thousands—in some cases, millions—of muscle fibers. These fibers are all bundled together and wrapped in a sheath of connective tissues. A strained muscle means, in a nutshell, that some number of the fibers that make up one of your muscles tore. This ripping can happen if you pull them too hard or too fast.

What we call a “tear” and what we coin a “pull or strain” all boil down to the same type of injury: A rip to some part of the muscle. But some are worse than others. A mild or “grade one” strain—what many people call a “pulled muscle”—happens when you tear about 5 percent of the fibers in a particular muscle. This typically feels like an uncomfortable twinge that may force you off the court for a few weeks. A moderate sprain involves a higher percentage of fibers, and might sideline you for a month or more. A full rupture severs the muscle entirely, and usually requires surgery to repair.

[Related: Why do my muscles ache the day after a big workout?]

Okay, but how exactly do these tears occur? And why do some instances result in more muscle fiber damage than others? Cramer says three major factors contribute to this muscle busting. Muscles that cover two joints, like the hamstring which extends across the hip and knee joints, are at the highest risk. That’s because having both joints moving and stretching the muscle simultaneously adds tension, which can lead to strains.

Muscles are also more likely to strain while they are contracting. At this point, muscles are shortening and lengthening at the same time. During a dumbbell curl, for example, raising the weight up towards the shoulder compresses the bicep, and lowering it back down stretches it back out again. The muscle can create and sustain much more force during the lengthening portion of the activity, says Cramer, which makes it easier for it to strain.

Finally, muscles that have a higher proportion of fast-twitch to slow-twitch fibers strain more readily. Fast-twitch fibers contract quickly and generate more power, says Cramer. For that reason, they are the ones recruited for explosive tasks like sprinting. “It’s relatively uncommon for slow twitch [muscles] to strain,” he says. “They’re used to being active all the time.”

Technically, Cramer says, it’s possible to strain any of the skeletal muscles in your body. “For some, it’s not physiologically impossible, just very highly unlikely,” he says. “You’re probably not going to strain deep muscles with very specific functions.” The muscles in the finger, for example, are probably not going to cause much trouble, since they only have one task and don’t do much heavy lifting.

[Related: How to get muscle gains: A beginner’s guide to becoming buff]

Low flexibility and range of motion are major factors at risk for muscle strain, says Cramer. Despite the popular belief that larger muscles are tighter, Cramer says greater muscle mass is actually associated with greater give. “There’s evidence to suggest that weight training done with a good range of motion increases flexibility,” he says. And even though it may not seem like it when you’re struggling to touch your toes, Cramer says most people can teach their body to be springy enough to do the splits. So, to help keep your muscle fibers intact—pick up the weights and don’t skip your stretching routine, no matter how tedious it is.

How does a pulled muscle heal?

For at-home ways to treat to minor strains, clinicians often recommend what’s known by the acronym R.I.C.E.: resting the pulled muscle; icing it for about 30 minutes; compressing it with an elastic bandage; and elevating it above your heart. While ice packs can reduce pain and swelling, some recent physiology studies suggest regular baths in chilly water might hinder recovery. (A small amount of inflammation, which encourages the flow of blood and nutrients, can actually help muscles restore their strength.) What clearly works is rest: You don’t need to completely avoid all physical activities, but taking it easy—and getting plenty of sleep at night—gives your body the opportunity it needs to heal itself.

This post has been updated. It was originally published on September 28, 2017. It was also previously updated to reflect the fact that stretching in general—not at any specific time—can help to prevent low flexibility, a risk factor for muscle strains.

The post Here’s what really happens when you pull a muscle appeared first on Popular Science.

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Doctors recorded brainwaves to finally ‘see’ their patients’ chronic pain https://www.popsci.com/health/chronic-pain-brainwaves/ Mon, 22 May 2023 21:39:29 +0000 https://www.popsci.com/?p=542700
Asian person with mid-length gray hair rubbing temples because of chronic pain
Chronic pain can stem from any number of illnesses or injuries, but it's difficult to study in individual patients. Deposit Photos

In a first, deep brain stimulation was used to measure uncontrollable, long-term pain in four people, opening a door to personalized care in the future.

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Asian person with mid-length gray hair rubbing temples because of chronic pain
Chronic pain can stem from any number of illnesses or injuries, but it's difficult to study in individual patients. Deposit Photos

Everyone has different perceptions of pain. Some can sit for hours getting tattooed for an arm sleeve, while others squirm at having their finger pricked. Because pain is subjective, doctors have a hard time evaluating and treating patients who are dealing with it chronically.

Now, neurologists have successfully used a person’s brain signals to predict how much pain they were feeling. The small but unprecedented study, published today in the journal Nature Neuroscience, identified hard clues in brainwaves that could objectively measure the intensity of chronic pain versus acute pain. 

The findings are part of a larger clinical trial aimed at creating a personalized brain stimulation therapy that could bring relief to the 51.6 million Americans living with chronic pain. Another recent study in the journal JAMA Network Open reported that the rate of chronic pain in the US was as high as other common health issues like diabetes, depression, and high blood pressure. 

“For the first time, the authors were able to understand and visualize the differences between the acute and chronic pain experience on a neural level,” says Akanksha Sharma, a neurologist at the Pacific Neuroscience Institute in California who was not involved in the research. “This is novel and important, learning how and where our brain perceives and processes acute and chronic pain and understanding how the individual brain rewires in response to chronic pain.”

[Related: Medical startup put useless plastic implants in chronic pain patients, says FBI]

The study authors invited four people with uncontrollable long-term pain—three recovering from strokes and one with phantom limb syndrome—to get implants that tracked neural activity. The patients had exhausted all their treatment options. “They tried medications, injections, and nothing was working. Brain surgery was the last resort,” says lead author Prasad Shirvalkar, a neurologist and pain medicine specialist at the University of California, San Francisco. 

Each participant underwent deep brain stimulation, a medical procedure that acts like a pacemaker for the cerebrum. The medical team implanted electrodes in specific areas to detect and record electrical activity from two brain regions associated with pain: the anterior cingulate cortex and the orbitofrontal cortex. The technique is commonly used for neurological conditions such as epilepsy and Parkinson’s, but has never been tested with chronic pain. 

For three to six months, the participants answered surveys about the severity and quality of their pain. Immediately after, they pressed a remote to let the electrode implants take a snapshot of their brain activity. A computer then used the recordings and survey responses to build models that calculated a pain severity score for each patient. Changes in the orbitofrontal cortex helped inform the personalized neural signatures more than any other brain region.

X-ray of chronic pain patient with activity tracking electrodes
Frontal x-ray image of one study participant, showing implanted brain recording electrodes (red patches) connected to a bidirectional brain stimulating and recording implant on both sides. Prasad Shirvalkar

“This information can help drive more customized treatment options for patients,” Sharma says. “If we can objectively “see” the pain experience of a patient, then we can potentially modulate those areas of the brain with new interventions to alleviate or change the perception of pain.”

Brain activity recordings also showed a difference between chronic and acute pain. Signs of chronic pain were more strongly associated with changes in how neurons in the orbitofrontal cortex fired. According to Shirvalkar, this brain region is understudied in its role in shaping the pain experience. The anterior cingulate cortex, on the other hand, is better known for its role in perceiving and processing pain across the body. This brain region was found to be more associated with acute pain.

The team learned that they couldn’t apply the same kinds of brain activity used to chart acute pain in therapeutic research to chronic pain in the real world. “Chronic pain is not a more enduring version of acute pain—it’s fundamentally different in the brain with different circuits,” Shirvalkar explains.

Understanding the differences in how patients are neurologically wired for acute versus chronic pain can help further personalized brain stimulation therapies for the most severe forms of discomfort. Medhat Mikhael, a pain management specialist at the MemorialCare Orange Coast Medical Center in California who did not contribute to the research, says this would help treat the most difficult of chronic pain cases, especially those stemming from a stroke and traumatic brain injury.

[Related: The slow, but promising progress of electrode therapy for paralysis]

While Sharma finds the work fascinating, she warns people to exercise caution in interpreting the data and generalizing it to all neuropathic pain conditions, given that there were only four people in the trial. The study authors say their next goal is to recruit six patients and then move on to a phase two trial where the sample size would increase to 20 or 30 patients. There’s also a risk of life-altering complications with surgical implants in the brain. At the moment, Shirvalkar says noninvasive methods such as electroencephalography and functional MRIs would not be able to record for long periods of time. However, he hopes that one day tech companies can make small wearable devices that track brainwaves. 

“Treating pain relies on subjective reporting, or on how the person with pain communicates their pain to their provider. Not everyone’s pain is believed or treated equally,” Kate Nicholson, the executive director and founder of the National Pain Advocacy Center, wrote in an email to PopSci. “For these reasons, the search for phenotypes and objective measures for pain is the search for a holy grail in pain management. Objective measures [like the ones found through this study], if valid and validated, hold promise to transform pain’s assessment and treatment.”

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A once-forgotten antibiotic could be a new weapon against drug-resistant infections https://www.popsci.com/health/nourseothricin-antibiotic-resistant-bacteria/ Tue, 16 May 2023 18:00:00 +0000 https://www.popsci.com/?p=541348
Two doctors performing lab tests, one looking into a microscope and the other using a pipette.
The rise of antibiotic-resistant bacterial infections has encouraged a search for new antibiotics. Deposit Photos

After 80 years, scientists are testing out nourseothricin's ability to combat today's difficult-to-treat bacteria.

The post A once-forgotten antibiotic could be a new weapon against drug-resistant infections appeared first on Popular Science.

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Two doctors performing lab tests, one looking into a microscope and the other using a pipette.
The rise of antibiotic-resistant bacterial infections has encouraged a search for new antibiotics. Deposit Photos

Doctors may have a new tool to protect patients against multi-drug resistant bacterial infections. But the new defense against increasingly difficult-to-treat bacteria isn’t a brand new development—it is an 80 year-old antibiotic. A study published May 16 in the open access journal PLOS Biology looked at a natural product made in soil called nourseothricin that was discovered in 1942.

[Related: Kids all over the US are getting strep, but antibiotics are hard to come by.]

The rise of antibiotic-resistant bacterial infections has encouraged a search for new antibiotics. Antibiotic resistance is a very serious and growing medical problem—according to the Centers for Disease Control and Prevention, antimicrobial resistance killed at least 1.27 million people worldwide and was associated with close to 5 million deaths in 2019. In the United States, more than 2.8 million antimicrobial-resistant infections occur each year, and over 35,000 people die as a result.

Nourseothricin contains multiple forms of a complex molecule called streptothricin. There were high hopes that the streptothricin inside would be a powerful agent against bacteria called gram-negative bacteria. These bacteria, such as E.coli., have a thick outer protective layer and are particularly hard for antibiotics to kill. 

Unfortunately, nourseothricin was toxic to kidneys according to the results of an unpublished limited human trial sometime in the 1940’s and its development was dropped. The team in this study decided to go back and take a second look at nourseothricin.

“We started searching around for drugs that we could use, and it turns out these super resistant bugs were highly susceptible to streptothricin, so we were able to use it as a selection agent to do these experiments,” study co-author and pathologist at Harvard Medical School James Kirby said in a statement. “What scientists were isolating in 1942 was not as pure as what we are working with today. In fact, what was then called streptothricin is actually a mixture of several streptothricin variants. The natural mixture of different types of streptothricins is now referred to as nourseothricin.”

Kirby is also the director of the Clinical Microbiology Laboratory at Beth Israel Deaconess Medical Center.

Diseases photo
Streptothricin-F (yellow spheres) bound to the 16S rRNA (green) of the bacterial ribosome impinges on the decoding site where tRNA (purple) binds to the codon of the mRNA (blue). This interaction leads to translation infidelity (scrambled protein sequences), and the resulting death of the bacterial cell. CREDIT: James Kirby, Zoe L .Watson et al., 2023, eLife, CC-BY 4.0.

In the earlier studies on the antibiotic, nourseothricin suffered from incomplete purification of  streptothricin which was likely causing the toxicity. A study published in 2022 showed that multiple forms of streptothricin actually have different toxicities. 

One called streptothricin-F was significantly less toxic while also working against present day pathogens that are resistant to multiple drugs. 

[Related: Raw dog food can harbor antibiotic-resistant bacteria.]

In this study, the team looked closely at streptothricin-F and also streptothricin- D. Streptothricin-D strain was also highly selective for the gram-negative bacteria and was even more powerful than streptothricin-F against drug-resistant Enterobacterales and other bacterial species. However, it caused renal toxicity at a lower dose. 

The team used cryo-electron microscopy to show that streptothricin-F bound extensively to a subunit of the bacterial ribosome. This binding causes translation errors in the bacteria, which helps antibiotics inhibit the spread of a bacterial infection.  

“It works by inhibiting the ability of the organism to produce proteins in a very sneaky way. When a cell makes proteins, they make them off a blueprint or message that tells the cell what amino acids to link together to build the protein. Our studies help explain how this antibiotic confuses the machinery so that the message is read incorrectly, and it starts to put together gibberish. Essentially the cell gets poisoned because it’s producing all this junk,” said Kirby.

The team is still trying to figure out the mechanism behind how nourseothricin works, but found that it acts differently than other antibiotics. Kirby will continue studying nourseothricin with collaborators at Northwestern University and Case Western Reserve University Medical Center to dive deeper and understand how it actually works.

“We have great collaborators that have allowed us to pursue a project that crosses multiple fields. This work is an example of collaborative science really at its best,” said Kirby. 

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AI isn’t ready to act as a doctors’ assistant https://www.popsci.com/health/ai-doctors-office-healthcare/ Tue, 16 May 2023 01:00:00 +0000 https://www.popsci.com/?p=541203
Preliminary research paper examining ChatGPT and Google products using board examination questions from neurosurgery found a hallucination rate of 2%.
Preliminary research paper examining ChatGPT and Google products using board examination questions from neurosurgery found a hallucination rate of 2%. DepositPhotos

Between privacy concerns and errors from the buzzy tech, the medical community does not have 'a really good clue about what’s about to happen.'

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Preliminary research paper examining ChatGPT and Google products using board examination questions from neurosurgery found a hallucination rate of 2%.
Preliminary research paper examining ChatGPT and Google products using board examination questions from neurosurgery found a hallucination rate of 2%. DepositPhotos

This article was originally featured on KFF Health News.

What use could health care have for someone who makes things up, can’t keep a secret, doesn’t really know anything, and, when speaking, simply fills in the next word based on what’s come before? Lots, if that individual is the newest form of artificial intelligence, according to some of the biggest companies out there.

Companies pushing the latest AI technology — known as “generative AI” — are piling on: Google and Microsoft want to bring types of so-called large language models to health care. Big firms that are familiar to folks in white coats — but maybe less so to your average Joe and Jane — are equally enthusiastic: Electronic medical records giants Epic and Oracle Cerner aren’t far behind. The space is crowded with startups, too.

The companies want their AI to take notes for physicians and give them second opinions — assuming they can keep the intelligence from “hallucinating” or, for that matter, divulging patients’ private information.

“There’s something afoot that’s pretty exciting,” said Eric Topol, director of the Scripps Research Translational Institute in San Diego. “Its capabilities will ultimately have a big impact.” Topol, like many other observers, wonders how many problems it might cause — like leaking patient data — and how often. “We’re going to find out.”

The specter of such problems inspired more than 1,000 technology leaders to sign an open letter in March urging that companies pause development on advanced AI systems until “we are confident that their effects will be positive and their risks will be manageable.” Even so, some of them are sinking more money into AI ventures.

The underlying technology relies on synthesizing huge chunks of text or other data — for example, some medical models rely on 2 million intensive care unit notes from Beth Israel Deaconess Medical Center in Boston — to predict text that would follow a given query. The idea has been around for years, but the gold rush, and the marketing and media mania surrounding it, are more recent.

The frenzy was kicked off in December 2022 by Microsoft-backed OpenAI and its flagship product, ChatGPT, which answers questions with authority and style. It can explain genetics in a sonnet, for example.

OpenAI, started as a research venture seeded by Silicon Valley elites like Sam Altman, Elon Musk, and Reid Hoffman, has ridden the enthusiasm to investors’ pockets. The venture has a complex, hybrid for- and nonprofit structure. But a new $10 billion round of funding from Microsoft has pushed the value of OpenAI to $29 billion, The Wall Street Journal reported. Right now, the company is licensing its technology to companies like Microsoft and selling subscriptions to consumers. Other startups are considering selling AI transcription or other products to hospital systems or directly to patients.

Hyperbolic quotes are everywhere. Former Treasury Secretary Larry Summers tweeted recently: “It’s going to replace what doctors do — hearing symptoms and making diagnoses — before it changes what nurses do — helping patients get up and handle themselves in the hospital.”

But just weeks after OpenAI took another huge cash infusion, even Altman, its CEO, is wary of the fanfare. “The hype over these systems — even if everything we hope for is right long term — is totally out of control for the short term,” he said for a March article in The New York Times.

Few in health care believe this latest form of AI is about to take their jobs (though some companies are experimenting — controversially — with chatbots that act as therapists or guides to care). Still, those who are bullish on the tech think it’ll make some parts of their work much easier.

Eric Arzubi, a psychiatrist in Billings, Montana, used to manage fellow psychiatrists for a hospital system. Time and again, he’d get a list of providers who hadn’t yet finished their notes — their summaries of a patient’s condition and a plan for treatment.

Writing these notes is one of the big stressors in the health system: In the aggregate, it’s an administrative burden. But it’s necessary to develop a record for future providers and, of course, insurers.

“When people are way behind in documentation, that creates problems,” Arzubi said. “What happens if the patient comes into the hospital and there’s a note that hasn’t been completed and we don’t know what’s been going on?”

The new technology might help lighten those burdens. Arzubi is testing a service, called Nabla Copilot, that sits in on his part of virtual patient visits and then automatically summarizes them, organizing into a standard note format the complaint, the history of illness, and a treatment plan.

Results are solid after about 50 patients, he said: “It’s 90% of the way there.” Copilot produces serviceable summaries that Arzubi typically edits. The summaries don’t necessarily pick up on nonverbal cues or thoughts Arzubi might not want to vocalize. Still, he said, the gains are significant: He doesn’t have to worry about taking notes and can instead focus on speaking with patients. And he saves time.

“If I have a full patient day, where I might see 15 patients, I would say this saves me a good hour at the end of the day,” he said. (If the technology is adopted widely, he hopes hospitals won’t take advantage of the saved time by simply scheduling more patients. “That’s not fair,” he said.)

Nabla Copilot isn’t the only such service; Microsoft is trying out the same concept. At April’s conference of the Healthcare Information and Management Systems Society — an industry confab where health techies swap ideas, make announcements, and sell their wares — investment analysts from Evercore highlighted reducing administrative burden as a top possibility for the new technologies.

But overall? They heard mixed reviews. And that view is common: Many technologists and doctors are ambivalent.

For example, if you’re stumped about a diagnosis, feeding patient data into one of these programs “can provide a second opinion, no question,” Topol said. “I’m sure clinicians are doing it.” However, that runs into the current limitations of the technology.

Joshua Tamayo-Sarver, a clinician and executive with the startup Inflect Health, fed fictionalized patient scenarios based on his own practice in an emergency department into one system to see how it would perform. It missed life-threatening conditions, he said. “That seems problematic.”

The technology also tends to “hallucinate” — that is, make up information that sounds convincing. Formal studies have found a wide range of performance. One preliminary research paper examining ChatGPT and Google products using open-ended board examination questions from neurosurgery found a hallucination rate of 2%. A study by Stanford researchers, examining the quality of AI responses to 64 clinical scenarios, found fabricated or hallucinated citations 6% of the time, co-author Nigam Shah told KFF Health News. Another preliminary paper found, in complex cardiology cases, ChatGPT agreed with expert opinion half the time.

Privacy is another concern. It’s unclear whether the information fed into this type of AI-based system will stay inside. Enterprising users of ChatGPT, for example, have managed to get the technology to tell them the recipe for napalm, which can be used to make chemical bombs.

In theory, the system has guardrails preventing private information from escaping. For example, when KFF Health News asked ChatGPT its email address, the system refused to divulge that private information. But when told to role-play as a character, and asked about the email address of the author of this article, it happily gave up the information. (It was indeed the author’s correct email address in 2021, when ChatGPT’s archive ends.)

“I would not put patient data in,” said Shah, chief data scientist at Stanford Health Care. “We don’t understand what happens with these data once they hit OpenAI servers.”

Tina Sui, a spokesperson for OpenAI, told KFF Health News that one “should never use our models to provide diagnostic or treatment services for serious medical conditions.” They are “not fine-tuned to provide medical information,” she said.

With the explosion of new research, Topol said, “I don’t think the medical community has a really good clue about what’s about to happen.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

AI photo

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Your guide to COVID testing for the unforeseeable future https://www.popsci.com/health/covid-testing-future/ Thu, 11 May 2023 19:53:22 +0000 https://www.popsci.com/?p=540661
Box of iHealth COVID rapid tests being distributed at a school before the US COVID public health emergency ended
A school superintendent grabs boxes of COVID-19 at-home testing kits to pass out to families before school starts next week at Canyon Middle School in Castro Valley, California. San Francisco Chronicle/Hearst Newspapers via Getty Images

Here's how to get COVID tests once the US stops giving them away.

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Box of iHealth COVID rapid tests being distributed at a school before the US COVID public health emergency ended
A school superintendent grabs boxes of COVID-19 at-home testing kits to pass out to families before school starts next week at Canyon Middle School in Castro Valley, California. San Francisco Chronicle/Hearst Newspapers via Getty Images

COVID-19 is no longer a public health emergency in the US. The Biden administration’s deadline follows the World Health Organization’s announcement last week that removed COVID’s status as a global health crisis.

Infectious disease experts tell Popular Science that it’s an encouraging step and a sign that we are in a very different place than where we were in 2020. And while the recent decisions in no way mean the virus is gone—it’s expected to be endemic like the flu—access to COVID testing, treatments such as Paxlovid, and the vaccines have put the US in a position to coexist with it.

That said, managing your safety will come at a higher cost now. In one of the biggest changes from ending the federal emergency response, insurances are no longer required to cover the costs of COVID testing or reimburse people if they bought an over-the-counter home COVID-19 test. The federal government is also ending its free COVID-test program over the mail. 

As the financial burden of testing shifts to families and individuals, knowing where and when to get tested will keep you protected as the country transitions into this new stage of the pandemic. “We’re still seeing up to 1,000 deaths a week in the US from COVID for people that are older and at risk,” warns Del DeHart, a medical director of the infectious diseases department at the University of Michigan Health-West. “For those people, COVID is still not over and so testing for early treatment is going to be critical.”

Where to get COVID tests

There are still options for getting free COVID tests around the US The last day to order four free at-home COVID tests from the government is May 31, but local community clinics can give away free COVID tests or at a lower cost until supplies run out. 

Access to free testing might also depend on where you live. David Souleles, the director of the COVID-Response Team at the University of California, Irvine, says some state governments are taking measures to avoid financial barriers with COVID testing. California, for example, issued a mandate for health insurances to continue providing reimbursement for eight monthly at-home tests. Check your state government’s website to see what policies are in place following the end of the public health emergency.

If you are uninsured, the US government will continue to provide access to swabs through the Increasing Community Access to Testing Program. This government program partners with specific healthcare sites such as Walgreens and Quest Diagnostics to provide no-cost COVID tests with priority for people with a known exposure to the virus or who are showing symptoms.

[Related: An at-home test for both COVID-19 and the flu gains approval]

At-home rapid tests and PCR laboratory testing will still be available at your local pharmacies and doctor’s office, but it’s up to your insurance company if they want to bear the cost or require a copayment. What’s more, insurance companies may charge different prices for COVID tests; if they cover the cost, they may set limits on how many tests they will cover per individual. 

Prices for COVID test kits in stores like CVS range from $9.99 to $28.99, meaning testing can quickly get expensive. DeHart is concerned that the prices will create a financial barrier that will deter people from getting tested. If affordability becomes a question, it’s important to make every COVID test you take count.

When it’s still important to get tested for COVID

While most COVID mandates have lifted around the country, some employers and places might require you to get tested. For instance, healthcare workers employed in facilities like nursing homes will likely continue routine COVID testing. And as of now, many hospitals still require routine COVID testing for admitted patients, though it remains unclear whether the hospitals will cover the cost or if the test will be added to a person’s medical bill.

For voluntary testing, it’s important to evaluate your risk of having a severe COVID infection. DeHart says individuals above the age of 65 and those with immunosuppressive conditions should get tested regularly, along with loved ones in close contact with those that fall under this category. Souleles also recommends taking a test before visiting a relative in assisted living or anyone who is considered at high-risk of exposure. 

Other scenarios may apply, too, Souleles adds. “We would still encourage people to test before and after travel and before and after gatherings if they have the ability to do so. Anytime that you have the ability to test before you’re going to be around lots of people is great, and anytime you have the ability to test three to five days after being around a lot of people, that’s also a good thing.”

[Related: Long COVID recovery is finally getting the attention it deserves in the US]

If you have COVID-like symptoms, get tested before going out in public, even if the side effects seem mild. Testing early will give you more chances to get Paxlovid, which is most effective when taken within the first five days of seeing symptoms, and potentially avoid life-threatening complications. 

If you need to purchase a COVID test, treat it like you would any other over-the-counter goods. This includes checking the expiration dates to avoid a false positive or false negative result. You will also want to throw out any recalled COVID tests. If purchased for a later date, keep COVID tests at room temperature and away from the hands of pets and young children.

What to do if you test positive for COVID

If the test comes out positive, follow the Centers for Disease Control and Prevention’s (CDC) guidelines. Stay home and isolate yourself from others in the household for five days. People experiencing moderate symptoms like difficulty breathing should isolate for 10 days. Monitor your condition and go to the hospital if there are any severe or life-threatening complications. 

If you must go outside, wear a high-quality mask and avoid going to places where you would have to take it off. Also contact your doctor to see if you are eligible for any COVID-19 treatments and start those as soon as possible.

You can stop isolating after five days if you have no symptoms. If you continue to show symptoms, the CDC says you should stay put until your symptoms improve or you are fever-free for 24 hours without using medication.

[Related: Getting COVID more than once might be even worse than we thought]

Keep in mind that COVID tests are only one of the many tools available to reduce your risk of severe infection and death. Both DeHart and Souleles strongly urge people to get vaccinated and get their booster shot when eligible. Insurers will still be expected to cover the bivalent COVID vaccine as a routine immunization, and the Biden administration’s Bridge Access Program for COVID-19 Vaccines and Treatments will continue to provide vaccines free-of-charge to the uninsured.

“Stay up to date with your vaccines,” says Souleles. “It’s still the most important tool that we have right now.”

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This soft robotic skull implant could change epilepsy treatment https://www.popsci.com/technology/soft-electrode-epilepsy-neurosurgery/ Thu, 11 May 2023 19:00:00 +0000 https://www.popsci.com/?p=540598
The device can be folded small enough to fit a 2 centimeter hole in the skull.
The device can be folded small enough to fit a 2 centimeter hole in the skull. 2023 EPFL/Alain Herzog

The flower-shaped device can fit through a tiny hole in the skull and then delicately unfold.

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The device can be folded small enough to fit a 2 centimeter hole in the skull.
The device can be folded small enough to fit a 2 centimeter hole in the skull. 2023 EPFL/Alain Herzog

After being approached by a neurosurgeon seeking a less invasive method to treat conditions that require a brain implant, a team of researchers at Switzerland’s Ecole Polytechnique Fédérale de Lausanne led by neurotechnology expert Stephanie Lacour started working. They took inspiration from soft robots to create a large cortical electrode array that can squeeze through a tiny hole in the skull. They published their findings in Science on May 10. 

A cortical electrode array stimulates, records, or monitors electrical activity in the brain for patients who suffer with conditions like epilepsy. Epilepsy is relatively common, and affects around 1.2 percent of the US’s population. The disorder is known to cause seizures, which are electrical activity bursts in the brain and may cause uncontrollable shaking, sudden stiffness, collapsing, and other symptoms. 

While microelectrode arrays were first invented decades ago, the use of these arrays for deep brain stimulation in epilepsy patients has only became FDA approved in the past handful of years. Even so, current devices often have certain trade offs, be it electrode resolution, cortical surface coverage, or even aesthetics, the authors write in their paper.

Engineering photo

The researchers created a superthin flower-shaped device that can be folded small enough to fit a 2 centimeter hole in the skull, where it can rest in between the skull and the surface of the brain—a tiny, delicate area that only measures around a millimeter in width. Once deployed, the flexible electrode releases each of its six spiraled arms one by one to extend across a region of the brain around 4 centimeters in diameter. Other devices may require a hole in the skull the same size as the diameter of the electrode array. 

 “The beauty of the eversion mechanism is that we can deploy an arbitrary size of electrode with a constant and minimal compression on the brain,” Sukho Song, lead author of the study, said in an EPFL statement. “The soft robotics community has been very much interested in this eversion mechanism because it has been bio-inspired. This eversion mechanism can emulate the growth of tree roots, and there are no limitations in terms of how much tree roots can grow.”

The device, however, isn’t exactly ready for human brains yet—the team has only tested it in a mini-pig—but will continue to be developed by a spinoff of EPFL Laboratory for Soft Bioelectronic Interfaces called Neurosoft Bioelectronics. 

“Minimally invasive neurotechnologies are essential approaches to offer efficient, patient-tailored therapies,” Lacour said in the EPFL statement.

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What is a pangenome? Scientists just released their first draft. https://www.popsci.com/science/pangenome-human-diversity-dna/ Wed, 10 May 2023 16:15:00 +0000 https://www.popsci.com/?p=540269
A diverse crowd of people.
This draft of the human pangenome included DNA from people across every continent except Australia and Antarctica. DEPOSIT PHOTOS

We're 99.9 percent genetically identical to each other. But that other 0.1 percent turns out to be pretty important.

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A diverse crowd of people.
This draft of the human pangenome included DNA from people across every continent except Australia and Antarctica. DEPOSIT PHOTOS

When the Human Genome Project launched in 1990, it was hailed as one of the greatest scientific endeavors of all time. The 13-year project identified about 20,000 genes and gave researchers a genetic blueprint to transform modern medicine. Doctors can now use genetic information to better diagnose diseases and debilitating conditions, such as linking a rare case of leg pain to a single mutation. The research also ushered in hope for an age of precision medicine, where every treatment would be tailored to the individual. There was only one problem—the work wasn’t really finished.

That’s because humans are 99.9 percent identical. But the 0.1 percent in genetic differences explains our uniqueness, and can also account for why some people are more susceptible to disease. Having one map of a single genome, which the 90s-era project produced, does not adequately represent the breadth of the human population.

An international study published today in Nature is filling in these gaps by analyzing a much more diverse set of genetic sequences. “We’re retooling the foundation of genomics to create a diverse and inclusive representation of human variation as the fundamental reference structure,” says senior study author Benedict Paten, an associate director at the University of California, Santa Cruz Genomics Institute. 

[Related: The benchmark for human diversity is based on one man’s genome. A new tool could change that.]

By eliminating bias and analyzing more inclusive genomic data, geneticists will have a better understanding of how mutations affect a person’s genes and move us closer to a future with equitable healthcare. 

What is a pangenome?

The research focused on creating a pangenome—a collection of DNA sequences within a single species. Past work focused on a reference genome, built from a few individuals, that was supposed to represent a broader set of genes. A pangenome, on the other hand, is created from multiple people worldwide to more accurately reflect our genetic diversity. 

It’s not as though past geneticists did not want to sequence more genetic variations—they just couldn’t. Erich Jarvis, a genetic professor at Rockefeller University Howard Hughes Medical Institute and a co-author of the study, says technology in the 90s and early 2000s did not allow researchers to see large variations between haplotypes—groups of genes inherited together from a single parent—within and across individuals. 

Biology photo

The focus of a pangenome is to study the genetic differences among individuals from across the world. Jarvis says knowing about genomic variations is important, because some mutations are associated with different traits and diseases. For example, the lipoprotein (a) gene has a complex structure that has not been sequenced in humans. But variations in the gene are known to be associated with an increased risk of heart disease among Black people. By sequencing the entire gene and understanding its variations, doctors may be able to revisit and treat previously unexplained cases of coronary heart disease.

“This paper helps us to understand that DNA [is] more than a sequence of letters; DNA is structurally organized, and human variation that structure is important for genomic function and trait diversity,” says Sarah Fong, a postdoctoral scholar studying human population variation at the University of California, San Francisco who was not involved in the study.

What does the first draft reveal?

The authors collected data on 47 genetically diverse individuals. About half came from Africa, with the others representing four other continents (excluding Australia and Antarctica). The genomic information added information on 119 million base pairs and 1,115 duplications—mutations where a portion of DNA on a gene is repeated. As expected, more than 99 percent of the genetic sequences were similar across individuals. But by including the less than one percent of variations in this new pangenome draft, the authors found that structural changes to genes explained 90 million of the identified base pairs. 

[Related: What we might learn about embryos and evolution from the most complete human genome map yet]

“By moving beyond a single, arbitrary, and linear representation of the genome, the work by the Pangenome Reference Consortium more accurately describes the diversity that exists in our species,” says Rajiv McCoy, an assistant professor of biology at Johns Hopkins University who was not involved in the current study but was recently involved in the first complete sequencing of the human genome.

With the latest pangenome model, it may become easier for geneticists to detect and characterize hard-to-find genetic mutations. When the authors analyzed a separate set of genetic information using the pangenome draft as a reference, they detected 104 percent more structural variants. They also improved the accuracy of the comparison sequence, reducing the  variant error rate by 34 percent.

Still a work in progress

Creating the first draft of the pangenome is only phase one of this two-part project. The second phase will take a couple of years, as the authors build collaborations among other international researchers and perform community outreach in areas where there is less genomic data, such as including members of indigenous cultures.

It might take decades before we see the drafts finalized into a complete picture of the human genome. There are several challenges to address, Fong says, such as the development of an efficient strategy to compare multiple human genomes and a concrete plan for testing for genetic variations in the medical field.

Still, Fong says the benefits will be worth the effort. Having complete, diverse human genomes will advance the way genetics is studied, and create a future where people’s genes are more fully considered when treating diseases.

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FDA approves first RSV vaccine for adults after 60 years in the making https://www.popsci.com/health/fda-rsv-first-vaccine/ Thu, 04 May 2023 14:00:00 +0000 https://www.popsci.com/?p=538976
An older woman sits on a hospital bed.
RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older every year. Deposit Photos

The vaccine will be given to individuals over the age of 60 and was 94 percent effective in preventing severe disease.

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An older woman sits on a hospital bed.
RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older every year. Deposit Photos

After 60 years of trial and error, the Food and Drug Administration (FDA) approved the first vaccine to prevent respiratory syncytial virus (RSV) on May 3. More preventative shots for the respiratory virus are on the way.

[Related: How our pandemic toolkit fought the many viruses of 2022.]

The FDA approved Arexvy from pharmaceutical company GSK. The vaccine is designed to protect those over 60 in a single dose. A vaccine from Pfizer is currently under consideration for older adults and pregnant people as a maternal vaccination to protect newborn babies. Sanofi and AstraZeneca’s monoclonal antibody treatment for babies that offers vaccine-like protection during RSV season is also under consideration by the FDA. Additionally, a late-stage trial of an RSV vaccine that uses mRNA technology from Moderna showed promise in late-stage trials

The vaccine could be available as soon as this fall, pending a recommendation for its use from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which will meet in June. GSK says it has “millions of doses ready to be shipped,” according to a recent earnings presentation.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

RSV can affect all age groups, but it is particularly worrisome in babies and older adults. It is a highly contagious virus that causes infections of the lungs and breathing passages. According to the Centers for Disease Control and Prevention (CDC), RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older every year. It is also a common cause of lower respiratory tract disease in older adults. This disease affects the lungs and can cause life-threatening pneumonia and bronchiolitis.

The virus circulates seasonally, usually beginning in the fall and peaking in the winter. The 2022-2023 RSV season started particularly early and flooded hospitals and pediatric wards across the United States, leading pharmacies to limit the sales of children’s medicines.

According to the results of a clinical trial of close to 25,000 older adults, the GSK vaccine was 83 percent effective at preventing lower respiratory tract disease by the virus. It was 94 percent effective at preventing severe disease in seniors. In the trial, severe disease was defined as the need for supplemental oxygen or a mechanical help to breathe. The results were published in the New England Journal of Medicine in February

[Related: Fighting RSV in babies starts with a mother’s antibodies.]

The vaccine works by using a small piece of the virus called a fusion protein, or F-protein. The F-protein sticks out on the virus’ surface and helps it latch onto cells in the upper airway and infect them. The F-proteins were made in a lab with specially programmed cells. 

In 2013, researchers at the National Institutes of Health discovered how to freeze the normally wiggly and shape-shifting F-protein in the shape that it takes before it fuses onto a cell. When it’s in this shape, the body can produce antibodies against it. The GSK vaccine uses this pre-fusion form of the F-protein and an ingredient called an adjuvant that can boost immune activity.

The search for a vaccine to RSV began in the 1960s, but has been mired by tragedy. Two toddlers died after receiving an experimental shot in the 60’s after it unexpectedly caused them to contract a very serious version of the virus. Many of the safety measures currently in place during vaccine trials were put in place after the failures of the RSV vaccine.

Barney Graham, a vaccine scientist at Morehouse School of Medicine worked alongside Jason McLellan, a structural biologist at the University of Texas at Austin, and Peter Kwong, a vaccine scientist at the National Institutes of Health, to jump-start the RSV vaccine field after decades of failure.

“This is my life’s work, so it’s kind of amazing to see it come to this point,” Graham told The Washington Post.  “It’s exciting for me to see this happening because of all the other people who’ve come before me working on RSV, some of whom are no longer with us. I wish they could see this is happening. It’s been a long struggle.”

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That time the CDC got people hyped for a zombie apocalypse https://www.popsci.com/health/if-it-sounds-like-a-quack-book-excerpt/ Thu, 04 May 2023 10:00:00 +0000 https://www.popsci.com/?p=538824
CDC zombie preparedness guide comic panel from 2011
A page from Preparedness 101: Zombie Pandemic, which was released back in 2011. Click the image credit to read it in full. <Centers for Disease Control and Prevention

American medicine is rife with fringe science. A journalist shines a light on some of the most bizarre examples.

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CDC zombie preparedness guide comic panel from 2011
A page from Preparedness 101: Zombie Pandemic, which was released back in 2011. Click the image credit to read it in full. <Centers for Disease Control and Prevention

Excerpted from If It Sounds Like a Quack: A Journey to the Fringes of American Medicine by Matthew Hongoltz-Hetling. Copyright © 2023. Available from PublicAffairs, an imprint of Hachette Book Group, Inc.

The year 2011, a tipping point for alternative healing, was important for another reason.

Deep beneath the Pacific Ocean, the edge of one tectonic plate was being jammed beneath the tectonic plate that held Japan. This wasn’t news. It had been happening at a rate of three inches a year since long before humans had invented the concept of news. But that March, it became news in the biggest possible way, when a chunk of the underlying plate suddenly gave way, causing the seafloor to pop up by about 15 feet and the plate holding parts of Japan to suddenly drop by about three feet. The magnitude 9 Tohoku earthquake was so big it shunted Japan eight feet to the east. It was so big it shifted the Earth six inches on its axis. It was so big it sped up the rotation of the planet
(only by 1.8 microseconds a day, but still—your days are now just a tiny bit shorter. Thanks Obama!). The earthquake and resultant tsunami also wreaked havoc on human systems—transportation systems, energy systems, water systems, telecommunication systems, and that most important of all human systems, the biological system that allows us to slobber, reproduce, and contemplate the irrationality of high baby-formula prices (usually in that order).

The tsunami killed more than twenty thousand people and caused multiple nuclear meltdowns, a disastrous toll for everyone except sellers of supplements, who pivoted to prey on the baseless fears of Americans living thousands of miles away from the radiation. Toby McAdam, still selling his RisingSun products, told the local newspaper that he doubted the radiation would drift to Montana—“but it could.” He recommended that his “Lugol’s Iodine solution” be applied to the skin daily as “an ounce of prevention.” Though public health officials said people self-treating with iodide supplements were more likely to harm than help themselves, orders spiked so sharply that Toby’s website crashed.

The multifaceted nature of the tsunami-caused chaos makes it perhaps appropriate that the event also marked the beginning of the United States’ descent into a full-blown zombie apocalypse.

The June following the earthquake, the CDC began a conversation about emergency preparedness on Twitter that led to a handful of people jokingly tweeting that they would like the CDC to weigh in on a catastrophic zombie attack.

This led to the predictable wave of lols, rofls, and laughy-face emoticons, but it also sparked an idea for Dave Daigle (a CDC communications administrator) and Dr. Ali S. Khan (a CDC expert in disaster preparedness).

With Daigle’s input, Khan wrote a piece for the CDC website explaining how to prepare for a zombie apocalypse. This neatly demonstrated the humanity of the person on the other side of the icy-cold stethoscope even as it leveraged the innate appeal of zombies to teach real-life strategies to cope with actual disasters.

It turned out people were hungry for messaging about people hungry for brains. The CDC zombie apocalypse preparedness plan was an instant hit, racking up so many views that the CDC server froze up, overwhelmed by all the traffic.

This bit of fun was so successful that a team of researchers from the University of California, Irvine, published a congratulatory paper in the journal Emerging Infectious Diseases urging other public health officials to follow suit. It argued that zombies were an opportunity “to capitalize on the benefits of spreading public health awareness through the use of relatable popular culture tools and scientific explanations for fictional phenomena.” They proposed that the medical establishment build o those efforts to stimulate the conversation and do better public education on a variety of health topics.

Suddenly, zombies were everywhere in public health and safety. The CDC, the Department of Homeland Security, and the Federal Emergency Management Agency all published in-depth zombie-related literature. Finally, public officials were seizing the initiative and taking back the cul tural space they had inadvertently ceded to promoters of One True Cures.

Also in 2011, a Harvard Medical School physician and aspiring nov elist named Steven Schlozman appeared on the radio show Coast to Coast AM, which spun tales of conspiracy and paranormal phenomena to a large and credulous national audience from 2 a.m. to 4 a.m., seven days a week. Because Coast to Coast AM was the most popular late-night radio show in the country, with ten million listeners, it was a great opportunity for Schlozman, who was there to promote his latest work, The Zombie Autopsies: Secret Notebooks from the Apocalypse. In the book, Schlozman drew on his medical knowledge to describe “Ataxic Neurodegenerative Satiety Deficiency syndrome” as the medical cause
of zombies (it was of course a fictional work of fictitious fiction). The format of the show required that Schlozman spend the opening stretch talking about the events of his novel as if they were real, before shifting to an acknowledgment that it was all pure fantasy.

Daigle, Khan, and Schlozman were helping people learn a bit of science in a fun way.

But their efforts quickly ran up against a problem: there is more than one way to view a zombie apocalypse.


One fact that the CDC and its fellow agencies failed to fully appreciate was that, in zombie properties like 2009’s feature film Zombieland and 2010’s hit television series The Walking Dead, very little
screen time is given to public health concepts like water sanitation. The action takes place after most health authorities have had their faces eaten, leaving individual survivors to run around attacking infected people with baseball bats, crossbows, and shotguns as a means of self-preservation.

That’s why other groups were quickly lining up to enlist the hot new cultural craze into their own, very different agendas. Zombies became the centerpiece in gun advertisements and were a major part of the NRA’s annual conventions, where shooting at the undead carried none of the moral baggage that came with shooting at human targets.

“Because the zombie canon focuses so squarely on the apocalypse, its spread into popular culture can erode faith in the resiliency of civilization,” wrote Daniel Drezner, the Tufts University professor and zombie expert. “The zombie narrative, as it is traditionally presented, socially constructs the very narrative that agencies like the CDC and FEMA are trying to prevent.”

Drezner documented the way that zombie references became a sort of dog whistle for gun rights—those on the outside glossed over a quirky head-scratcher while targeted audiences became fired up, even though they would clearly never need to shoot a zombie in real life.

Until some Americans began to ask, Will I need to shoot a zombie in real life?


Toby McAdam had told me about the 2012 Miami incident in which a man bit the face off a homeless man and then was himself described by authorities as slow to die after being shot. But Toby was not the only person fascinated by that attack. It let the undead cat out of the bag.

Soon after the news broke, a self-described Bitcoin evangelist and promoter of alternative-health supplements doctored a Huffington Post article about the incident so that it attributed the cause of the face eating to “LQP-79,” a virus that destroys internal organs and makes the host hungry for human flesh.

The fake article went viral, blitzing digital media feeds so thoroughly that LQP-79 was soon the third-most-searched term on the CDC website, forcing the agency to officially deny the existence of a zombie virus.

Around then, communities of zombie-themed survivalists and militias sprang up all across America. One was an offshoot of the well-established Michigan Militia, while others had names like the Kansas Anti Zombie Militia, the Anti Zombie Unified Resistance Effort (AZURE), Zombie-Fighting Rednecks, the Zombie Eradication and Survival Team, Postmortem Assault Squadron, and the US Department of Zombie Defense.

One, a loosely affiliated national group called the US Zombie Outbreak Response Team (ZORT), popularized a strange mishmash of survivalism and cosplay. Its website features pictures of preppers in tactical gear and tinted sunglasses using stickers and goofy accessories to trick out their trucks as zombie-fighting vehicles that would be equally at home in Ghostbusters or Mad Max universes. It was in some ways good fun. But they also carried real firearms. And engaged in real postapocalyptic survival exercises.

“A Zombie could be anything from a person infected by a pandemic outbreak to a crazy nut job, criminal or gangster who wants to hurt your family and steal your food and preps,” reads ZORT’s promotional material.

Though ZORT purports to be simply providing tongue-in-cheek cover for legit training that would be helpful in a natural disaster, of course the real difference between zombies and hurricane survivors is that one must be shot in the head and the other should be given a hot toddy and a shower.

Did any of these folks actually believe in zombies?

Probably not. But there was potential.

If It Sounds Like a Quack book cover with doctor and silhouette of a duck on bright yellow with navy all-caps text
Courtesy of PublicAffairs

Drezner cited research showing that when considering paranormal ideas, people look less to the logical evidence and more to whether other people believe in the ideas. This means that even if no one believes in zombies, if some people believe that other people believe in zombies, then some people will believe in zombies. The gaslighting became so effective that the gaslit then gaslighted others, until fear of actual zombies took on an undead life of its own—call it masslighting.

And really, the online picture was becoming quite blurry. At the CDC, Daigle and Khan began getting inquiries about their Zombie Preparedness Plan from concerned citizens who wanted to know what sort of firearm was recommended to repel undead invaders. Meanwhile, after his Coast to Coast AM appearance, Schlozman got emails from listeners who wanted to know what medicines could stave off a zombie infection, and whether he had recommendations for how to protect one’s home. China’s state media had to formally debunk a robust rumor that Ebola victims were rising from the dead as zombies. And in 2014 in the Florida statehouse, a representative formally proposed “An Act Relating to the Zombie Apocalypse” as the name of a bill that would allow citizens to carry firearms without a permit in an emergency.

Shockingly, a 2015 survey showed that 2 percent of American adults thought the most likely apocalyptic scenario would be one caused by zombies.

And zombie references kept popping up in unexpected places. People downloaded audio fitness tracks in which joggers were kept motivated by imaginary zombie antagonists that pursued them as they ran.

A man named Vermin Supreme, who sought the 2016 Libertarian Party nomination for president, added a platform plank on “zombie apocalypse awareness.” He also advocated using zombies for renewable energy. Even Big Tech was in on it. Buried in Amazon’s user agreement for a game-development engine, clause 57.10—a gag, probably?—read that the software should not be used in life-and-death situations, such as in medical equipment, nuclear facilities, spacecraft, or military combat operations. “However, this restriction will not apply in the event of the occurrence (certified by the United States Centers for Disease Control or successor body) of a widespread viral infection transmitted via bites or contact with bodily fluids that causes human corpses to reanimate and seek to consume living human flesh, blood, brain or nerve tissue and is likely to result in the fall of organized civilization.”

With zombie stories saturating popular culture, the lore in TV and film began to expand beyond the simple trope of shambling brain eaters. There were zombie rom-coms and zombie mockumentaries. On the CW Television Network, a show called iZombie tells the story of a Seattle morgue worker infected by a zombie virus. In this world, zombies retain their personality and capacity for reason, as long as they are well fed (on brains). During the third season, which aired in 2017, a militant group of zombies releases a deadly flu virus in Seattle; local public health officials announce a mandatory flu vaccination, only to find that the zombies have tainted the vaccines with a substance that will turn the vaccinated into zombies.

Vaccines that zombified ordinary citizens?

Luckily for public health, no one would believe that in real life.

Buy If It Sounds Like a Quack by Matthew Hongoltz-Hetling here.

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A tiny patch can take images of muscles and cells underneath your skin https://www.popsci.com/technology/wearable-ultrasound-patch/ Wed, 03 May 2023 20:00:00 +0000 https://www.popsci.com/?p=538733
Close-up of patient's neck with a wearable ultrasound patch
This small patch can monitor tissue up to four centimeters below the skin. UC San Diego Jacobs School of Engineering

Researchers built a device that can act like a tiny ultrasound.

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Close-up of patient's neck with a wearable ultrasound patch
This small patch can monitor tissue up to four centimeters below the skin. UC San Diego Jacobs School of Engineering

Researchers at the University of California San Diego have invented an adhesive, elastic patch capable of performing ultrasounds—but don’t expect any baby pictures just yet. Even without the social media fodder, the new wearable technology could soon provide an extremely useful tool for a wide array of medical monitoring procedures.

As detailed in a paper published on Monday in Nature Biomedical Engineering, a team led by nanoengineering professor Sheng Xu has developed a tiny, wearable device capable of measuring tissue stiffness up to 4 centimeters underneath the skin with a spatial resolution of 0.5 millimeters. In a statement, study coauthor and postdoctoral researcher Hongjie Hu explained that the group “integrated an array of ultrasound elements into a soft elastomer matrix and used wavy serpentine stretchable electrodes to connect these elements,” thus creating a conformable patch for portable medical monitoring.

According to the team’s paper, the device is composed of a 16-by-16 array of transducer elements connected via a seven-layer electrode. This is all protected by a waterproof and biocompatible silicone elastomer. A backing layer made from a composite of silver-epoxy helps absorb excessive vibrations to broaden bandwidth capabilities and improve resolution.

[Related: Wearable liquid pumps could one day regulate body temperature.]

All together, the patch comfortably conforms and “acoustically couples” to a patient’s skin to take repeated, three-dimensional images of underlying tissue. Compared with traditional ultrasound technology, the new patch can take the monitoring outside of hospital settings and eliminates the need for staff assistance. “This allows patients to continuously monitor their health status anytime, anywhere,” added Hu.

One significant challenge the team initially encountered involved the actual manufacturing of the patch. Traditional fabrication methods often require high-temperature bonding procedures that thermally damage the device’s sensitivity. To solve this problem, Xu’s team replaced their patch’s soldering paste with a conductive epoxy that bonded at room temperature, thus avoiding any burn-related problems.

Already, the team’s patch shows promise across a number of medical areas and research. Among the potential usages: monitoring the progression of cancerous cells, which often stiffen as they spread; assessing sports injuries affecting tendons, ligaments, and muscles; and analyzing the efficacy of treatments for liver and cardiovascular diseases alongside chemotherapy results. According to UC San Diego’s announcement, the ability to continuously monitor these health issues could aid in avoiding misdiagnosis and fatalities while also reducing costs via the new, non-invasive alternative to traditional hospital procedures.

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Scientists have developed a new way to fight a nearly untreatable brain cancer https://www.popsci.com/health/sound-waves-chemo-brain-cancer-glioblastoma/ Wed, 03 May 2023 14:00:00 +0000 https://www.popsci.com/?p=538676
Fluorescent dye shown crossing the blood-brain barrier into the brain via sound waves.
Fluorescent dye shown crossing the blood-brain barrier into the brain via sound waves. The Lancet Oncology

Crossing the blood-brain barrier may be crucial to provide glioblastoma therapy.

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Fluorescent dye shown crossing the blood-brain barrier into the brain via sound waves.
Fluorescent dye shown crossing the blood-brain barrier into the brain via sound waves. The Lancet Oncology

A new sound wave technique can help treat a deadly brain cancer called glioblastoma in only four minutes. The breakthrough report was published May 2 in the journal The Lancet Oncology and demonstrates the results of a phase 1 in-human clinical trial with 17 patients.

In the trial, the patients underwent surgery for resection, or removal, of their tumors and had an ultrasound device implanted. The device inside the skull opens the blood-brain barrier, repeatedly using sound waves to permeate the barrier and reach the brain tumor. IV chemotherapy is then able to reach the neurological tissues where the cancer can grow.

Treating this type of brain tumor, which has a 6.8 percent survival rate within the first five years of diagnosis, with the most potent types of chemotherapy is difficult. The strongest cancer medicines are typically unable to permeate the blood-brain barrier. The blood-brain barrier acts as a line of defense, making an extra wall around the brain to keep toxins and pathogens from getting into such a crucial area of the body. However, the repertoire of drugs that can be used to treat brain diseases is very limited. In 2014, scientists first found that sound waves could be used to permeate the blood-brain barrier and this study builds on that discovery.

[Related: Understanding glioblastoma, the most common—and lethal—form of brain cancer.]

“This is potentially a huge advance for glioblastoma patients,” co-author and Northwestern University neurosurgeon Adam Sonabend said in a statement

The study reports that using a novel skull-implantable grid of nine ultrasound emitters made by French biotech company Carthera can open the blood-brain barrier in a volume of the brain nine times larger than the small single-ultrasound emitter implants originally used. This importantly helps treat a large region of the brain next to the cavity that remains after glioblastoma tumors are removed.  

Cancer photo

This is also the first study that shows how quickly the blood-brain barrier closes after being opened by the ultrasound. It closes in the first 30 to 60 minutes after the communication. and this will help scientists optimize what order to deliver the drugs to allow for better penetration of the brain. The procedure to open the blood-brain barrier only takes four minutes and is performed while the patient is awake. The new results show that the treatment is safe, well-tolerated, and some patients received up to six cycles of treatment. 

[Related: Scientists used Zika to kill aggressive brain cancer cells in mice.]

Opening up the blood-brain barrier led to a roughly four- to six-fold increase in the drug concentrations in the human brain. The team observed this increase with two chemotherapy drugs called paclitaxel and carboplatin. These drugs are typically not used to treat glioblastoma patients, because they typically do not cross the blood brain barrier in normal circumstances. 

According to Sonobend, the current chemotherapy used for glioblastoma (Temozolomide) does cross the blood-brain barrier, but is weak. Sonabend also said that previous studies that injected paclitaxel directly into the brains of patients with these tumors had promising signs of efficacy, but the direct injection was associated with toxicity such as brain irritation and meningitis.

A phase 2 clinical trial is already underway. “While we have focused on brain cancer (for which there are approximately 30,000 gliomas in the U.S.), this opens the door to investigate novel drug-based treatments for millions of patients who suffer from various brain diseases,” said Sonabend.

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How to understand your prescription’s fine print https://www.popsci.com/health/prescription-drugs-fine-print/ Tue, 02 May 2023 01:00:00 +0000 https://www.popsci.com/?p=537834
Package inserts contain information on the pharmacology of a drug.
Package inserts contain information on the pharmacology of a drug. Kathrin Ziegler/DigitalVision via Getty Images

A toxicologist explains how to decode package inserts to take medications safely and increase their effectiveness.

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Package inserts contain information on the pharmacology of a drug.
Package inserts contain information on the pharmacology of a drug. Kathrin Ziegler/DigitalVision via Getty Images

This article was originally featured on The Conversation.

Many adults take prescription drugs, and usage rates are continually increasing. With approximately 1.3 million emergency department visits in the U.S. caused by adverse drug events each year, patient education is becoming increasingly important.

All prescription drugs come with instructions on how to safely and effectively use them. Depending on the medication, there may be several types of information included: the patient package insert, medication guide and instructions for use. One or more of these documents could be folded up in the box or attached as a printed page provided by your pharmacist.

I am a scientist who studies how drugs and other chemicals affect human health. While they may look intimidating, package inserts – and particularly the prescribing information – can help patients better understand the science inside the pill bottle and blister pack, among others.

What can I learn from package inserts?

An often overlooked part of the package insert is the prescribing information. Though written primarily for health care professionals, it contains a wealth of information regarding the ways in which the medication interacts with the body.

If the prescribing information was not included with your prescription, you can often find a copy on the National Institutes of Health’s DailyMed website or other drug information websites.

As an example, let’s consider one of the most widely prescribed medications in the U.S., atorvastatin (Lipitor). Among other effects, it reduces elevated levels of cholesterol overall as well as levels of low-density lipoprotein cholesterol – LDL, or “bad” cholesterol.

Reading the insert can answer a few important questions about the drug. If you’d like to follow along, a copy of the prescription information for Lipitor can be found here.

How does the drug work?

To answer this question, you can refer to the “Mechanism of Action” and “Pharmacodynamics” subsections of the prescription insert.

The mechanism of action and pharmacodynamics are related concepts. The mechanism of action describes the chemical and molecular interactions that cause a drug’s therapeutic or toxic effects. Pharmacodynamics refers to “what the drug does to the body,” which includes the mechanism of action as well as how other factors like drug concentration influences its effects.

Often the mechanism of action of a drug is related to how it interacts with cell receptors and enzymes involved in mediating specific signals and biochemical reactions in the body.

In the case of Lipitor, the prescribing information tells us three important things about how the drug works. First, the liver is the primary site that produces cholesterol in the body and the area the drug is meant to target. Second, the drug works by inhibiting an enzyme involved in cholesterol production called HMG-CoA reductase. And third, the drug increases the number of LDL cholesterol receptors on cell surfaces, ultimately increasing the catabolism, or metabolic breakdown, of LDL cholesterol.

Where does the drug go in my body?

Before we answer this question, let’s start with some background information in the “Pharmacokinetics” subsection.

Pharmacokinetics can be thought of as “what the body does to the drug.” It focuses on four major processes the body undergoes in response to the chemical: absorption, or how the drug gets into the body; distribution, or how the drug is dispersed throughout the body; metabolism, or how the drug is converted into other chemical forms; and excretion, or how the drug is eliminated from the body.

The pharmacokinetics of a drug are determined by factors related to the chemical itself and the person taking the medication. For instance, disease state, age, sex and genetic makeup can all cause the same medication to work differently in different people.

Now, let’s look at the “Distribution” subsection.

For Lipitor, the prescription insert does not specifically say where the drug goes in the body, but it does note that the volume of distribution is 381 liters. The volume of distribution is the ratio of the amount of the drug in the body overall to its concentration in the blood. A value greater than about 30 liters suggests that the drug has entered body tissues and is not confined to the bloodstream. For reference, the drug warfarin, which prevents blood clots, is tightly bound to proteins in the blood and has a volume of distribution of only 8 liters. On the other hand, chloroquine, an antimalarial drug that enters body fat, has a value of 15,000 liters.

Does the drug cause the effects or its byproducts?

Though the therapeutic effects of most drugs come from the chemical compound it’s made of, many break down into active metabolites in the body that also have some relevant biological effects.

Some medications are administered in an inactive form called a prodrug that the body converts into metabolites with the desired therapeutic effects. Drugmakers generally use prodrugs because they have better pharmacokinetics – such as improved absorption and distribution in the body – than the active form of the drug.

In the case of Lipitor, the “Metabolism” subsection under “Pharmacokinetics” tells us that the drug is broken down into several products and that these metabolites contribute significantly to its therapeutic effect.

How long will the drug be in my system?

A key drug property to consider in this case is its half-life, which is the length of time required for the concentration of the drug to decrease to half of its initial amount in the body. Information about a drug’s half-life is found in the “Excretion” subsection under “Pharmacokinetics.”

The half-life for Lipitor is approximately 14 hours. If you were to stop taking the medication, 97% of the drug would be gone from your blood after about three days, or five half-lives.

The prescription insert provides another interesting piece of information: because Lipitor’s active metabolites have a longer half-life than the drug itself, the half-life for its cholesterol enzyme inhibiting effects is 20 to 30 hours. This means that the drug’s effects may last even after the drug itself is out of your system.

Medicine photo

Why do I need to take medications with food or at certain times?

Eating food can change the amount and rate at which a drug is absorbed into the body in several ways, including changing the acidity of the digestive system, altering the release of bile and increasing blood flow to the gut.

For Lipitor specifically, the answer to this question can be found in the “Absorption” subsection under “Pharmacokinetics.” Food decreases the rate and extent of Lipitor’s absorption but doesn’t significantly affect LDL cholesterol reduction.

Interestingly, the insert also states that the blood concentration of the drug is significantly lower when taken in the evening than in the morning, but reduction in LDL cholesterol levels is the same regardless of when the drug is taken.

The upshot of all of this is written on the drug label on the outside of the package: Lipitor can be taken with or without food. Morning or evening is not specified, but the recommendation is to take it at the same time every day.

Why does my doctor ask about other drugs I’m taking?

Drugs can interact with one another in ways that affect their safety and efficacy. For instance, two drugs may rely on the same enzyme system in the body to break them down. Taking them at the same time can ultimately lead to higher-than-anticipated levels of either or both drugs in the body.

Information to answer this question can be found in the “Drug Interactions” section.

One of the drug categories of concern for Lipitor are “strong inhibitors of CYP 3A4,” an enzyme that plays a key role in metabolizing many drugs. Because Lipitor itself is broken down by this enzyme, taking it alongside drugs that inhibit CYP 3A4, such as the antibiotic clarithromycin or the fungal infection drug itraconazole, can lead to its increased concentration in the blood and potentially result in adverse effects.The Conversation

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Banning the abortion pill would harm veterans, cancer patients, and many others https://www.popsci.com/health/abortion-pill-ban-other-treatments/ Mon, 01 May 2023 18:00:00 +0000 https://www.popsci.com/?p=537952
Black truck with purple screen that says "pharmacists know mifepristone saves lives" driving around Phoenix during abortion pill lawsuits
During the American Pharmacists Association annual conference in Phoenix, Arizona, this year, an advocacy group drove around a van urging pharmacists to reaffirm that mifepristone, a medication abortion drug, is safe, effective and essential. Chris Coduto/Getty Images for UltraViolet

Mifepristone's life-saving powers can go beyond pregnant people—if the courts allow research and access to continue.

The post Banning the abortion pill would harm veterans, cancer patients, and many others appeared first on Popular Science.

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Black truck with purple screen that says "pharmacists know mifepristone saves lives" driving around Phoenix during abortion pill lawsuits
During the American Pharmacists Association annual conference in Phoenix, Arizona, this year, an advocacy group drove around a van urging pharmacists to reaffirm that mifepristone, a medication abortion drug, is safe, effective and essential. Chris Coduto/Getty Images for UltraViolet

Three years ago, Nancy Klimas sat in an auditorium waiting to discuss her latest research progress. The audience was made up of the usual suspects at a scientific conference: doctors, scientists, and other academic colleagues. But this group was a bit different. The room was also packed to the brim with retired US veterans, all waiting to hear about any new developments over a “moonshot” idea that could be the closest attempt to a cure for Gulf War illness

Klimas, who serves as the director for the Institute for Neuro-Immune Medicine at Nova Southeastern University in Florida, has been studying this debilitating condition for three decades. The strange sickness affects 175,000 to 250,000 soldiers who were deployed in the 1990-1991 Persian Gulf War. For those veterans, nearly half of who are pushing 50 or above, life has been an uphill battle. There is currently no cure for Gulf War illness, and because it involves a cluster of symptoms—fatigue, joint pain, diarrhea, memory loss—attempts to treat it have come up short. “These people served our country and put themselves in harm’s way,” says Klimas. “Now they’re sick with a chronic illness that ruined their quality of life and ability to work for more than 30 years.” Exhausting her options, Klimas came up with a rather unconventional idea: use a well-established abortion drug to reset the body’s overwhelming response to chronic illness.

[Related: The PACT Act will take the burden of proof off US veterans exposed to burn pits]

Mifepristone, more widely known as the abortion pill, is capable of treating multiple illnesses. At low doses and when paired with another pill, misoprostol, the synthetic steroid binds to a protein in the uterus and stops the release of progesterone and other hormones needed to sustain pregnancy. But the drug has another effect, which Klimas is looking to tap. When taken at higher doses, mifepristone also blocks hormone receptors in the adrenal gland, which regulates the body’s stress response. The drug has already proven capable of doing this, and is currently approved as a treatment for the metabolic disorder Cushing’s syndrome

Based on that evidence, Klimas wondered if the medication could temporarily block the adrenal gland and rebalance the hormone signals that are blunted with Gulf War illness. Repurposing the FDA-approved drug would also save the 10 to 15 years it would take to develop and test a brand-new drug. Klimas is halfway through her phase 1 trial testing the safety of the drug at different dosages on veterans, and is making plans for the second phase of the study. 

The recent legal mess surrounding mifepristone access threw a wrench in Klimas’s plans, along with those of other researchers using mifepristone in their work. In early April, a federal circuit judge in Texas overturned the FDA’s 23-year-long approval of mifepristone, citing claims that the drug is unsafe for public use because abortion is now illegal in some states. And while the Supreme Court blocked the ruling that would have suspended mifepristone access across clinics, pharmacies, and mail orders, the future of the treatment remains uncertain in the US. “Obviously, we’re very concerned,” says Klimas, adding that mifepristone was already hard to get for research purposes. “Attempts to limit access to this drug has already had a splashback on the veteran population in these trials, as we’re delayed in rolling things out. How long will they have to wait for an effective therapy?”

Further constraints on mifepristone could impact medical progress on many other diseases and conditions as well. The medication is being studied as a potential treatment for diabetes in people without Cushing’s syndrome. It has also shown some potential in preventing weight gain caused by antipsychotic medication. Some ongoing clinical trials have found that mifepristone can be effective in slowing down the spread of breast cancer: The drug blocks progesterone receptors from releasing the hormone, which would normally stimulate tumor cell growth. And at different dosages, the pill can improve the quality of life of people dealing with painful uterine growths.

[Related: Abortion bans are impeding access to ulcer, arthritis, and cancer medications]

Banning mifepristone goes beyond stalling research—it puts any FDA-approved treatment at risk of being recalled. “You have a medication with an excellent track record of safety, efficacy, and high patient satisfaction,” says Carrie Cwiak, an OB-GYN at Emory Healthcare in Georgia. “The idea that the entire process for approving medication can be overturned [in court] is earth-shattering.” She says that restricting mifepristone opens a dangerous door to having people with legal power make treatment decisions based on their opinion and ideology rather than medical evidence. 

If the courts decide to bar or limit mifepristone use down the line, it would discourage pharmaceutical companies from spending money on producing new drugs that appear controversial. That could include contraceptives, hormone blockers, or treatments completely unrelated to reproductive issues. “If you were a pharmaceutical company and it was going to cost you $20 million to move a pipeline drug all the way up through phase three [clinical trials], would you want to invest the money for it if it’s possible the bench could reverse the authority of the FDA?” Klimas asks. 

Despite the setbacks on mifepristone access and potential legal battles, Klimas is optimistic that the research she is doing will help give veterans their long and overdue treatment. Her team is hoping to start their phase 2 trial soon and get as many results before politics interferes in science again. 

The post Banning the abortion pill would harm veterans, cancer patients, and many others appeared first on Popular Science.

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A cutting-edge appetite stimulator was inspired by the thorny devil lizard https://www.popsci.com/technology/thorny-devil-lizard-gut-health/ Fri, 28 Apr 2023 15:00:00 +0000 https://www.popsci.com/?p=537523
Side by side of Australian thorny devil lizard and ingestible medical capsule
The thorny devil lizard's moisture wicking skin inspired a new ingestible medical device. Deposit Photos/MIT/Popular Science

The spiky reptile's unique hydration methods helped craft a brand-new fluid-wicking stomach tool.

The post A cutting-edge appetite stimulator was inspired by the thorny devil lizard appeared first on Popular Science.

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Side by side of Australian thorny devil lizard and ingestible medical capsule
The thorny devil lizard's moisture wicking skin inspired a new ingestible medical device. Deposit Photos/MIT/Popular Science

Your stomach is extremely moody—at any given time, a complex interplay of factors such as hormone production and various neurological signals can leave you feeling hungry, overstuffed, excited, or nauseous. These experiences stem directly from the enteric nervous system (ENS), which controls gastrointestinal tract functions along a path known as the gut-brain axis. The ENS is so complex, in fact, that it is often referred to as your “second brain.”

Because of this, there are a number of ways for things to go sideways, resulting in issues such as suppressed appetites and slow digestion. Recently, however, researchers developed a first-of-its-kind treatment to help spur hunger via stimulating hormone levels in the gut—an “electroceutical” ingestible capsule inspired by a “water wicking” reptile.

In a new paper published by a team of scientists at NYU Abu Dhabi working alongside experts at MIT, the team explored a novel way to “significantly and repeatedly” induce the production of ghrelin, a hormone that triggers hunger. To accomplish this, they looked to the Australian thorny devil lizard, whose spiky skin is evolved to transport any water it touches towards the reptile’s mouth. Similarly, the research team’s ingestible device features a grooved, hydrophilic exterior designed to defer fluids away from the stomach’s inner lining. When this occurs, the pill-shaped tool’s electrodes come into direct contact with the tissue to produce a tiny current stimulating ghrelin production.

[Related: Doctors need to change the way they treat obesity.]

Dan Azagury, an associate professor and Chief of Minimally Invasive and Bariatric Surgery at Stanford University who was not involved in the study, admired the new device, and said they found the findings “really intriguing.”

“I love the creativity of the device, the idea, and how they found a way to get around the fluid constraints,” Azagury said via email, but cautioned that “even if that works, the path for this to show clinical efficacy in a disease as complex as obesity, is very, very challenging.”

Azagury points towards experts’ still relatively poor understanding of gut hormones and the gut-brain axis, which are “more complex than we think, and likely underutilized.” As an example, he offered that the “new blockbuster drugs” used to treat obesity are based on gut hormones only discovered in the 1980s, far after doctors had begun performing weight loss surgeries.

Although Azagury estimates there is a “long road ahead” before the device is commercially used to treat diseases, its creators are more optimistic. “It’s a relatively simple device,” Giovanni Traverso, an associate professor of mechanical engineering at MIT and gastroenterologist at Brigham and Women’s Hospital, and the senior author of the study, argued in a statement for MIT. “So we believe it’s something that we can get into humans on a relatively quick time scale.”

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Do children really need root canals? https://www.popsci.com/health/root-canal-dentistry-children/ Fri, 28 Apr 2023 01:00:00 +0000 https://www.popsci.com/?p=537163
Deciding how to treat young patients in dentistry isn’t always straightforward, and the challenge is compounded by a relative lack of evidence and clinical guidance.
Deciding how to treat young patients in dentistry isn’t always straightforward, and the challenge is compounded by a relative lack of evidence and clinical guidance. Getty Images

Insurance reimbursements tend to incentivize intervention over prevention, which isn’t always supported by evidence.

The post Do children really need root canals? appeared first on Popular Science.

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Deciding how to treat young patients in dentistry isn’t always straightforward, and the challenge is compounded by a relative lack of evidence and clinical guidance.
Deciding how to treat young patients in dentistry isn’t always straightforward, and the challenge is compounded by a relative lack of evidence and clinical guidance. Getty Images

This article was originally published on Undark.

When a dentist told Corrine Rivera that her 7-year-old daughter needed a baby root canal at her routine checkup, Rivera didn’t understand that “baby” was describing the tooth, not the size of the procedure. She imagined it was like a baby ice cream cone — less than what an adult gets, just a little bit of a root canal. Rivera’s daughter had yet to have any dental interventions other than cleanings, so Rivera didn’t realize what she was in for.

The dentist, Rivera recalled, proceeded with the root canal right then and there. It was painful for her daughter, who had to endure large tools in her mouth for the unexpected hour-and-a-half long procedure, and distressing for Rivera. “I just wanted what was best for my daughter’s teeth at the time,” she said about that 2017 experience at Pediatric Dentistry of Albany, in New York state. “Unfortunately,” she added, “having the procedure led to a hell of a lot more problems.”

 

A few months later, Rivera said her daughter developed an infection, and a new dentist at a different practice explained to her that a baby root canal, or pulpotomy, is a root canal on a baby tooth, not a “mini” procedure.

Rivera remains skeptical that her daughter needed a root canal in the first place, and state and federal prosecutors, it turns out, later responded to allegations that other pulpotomy cases in that same dental practice had been medically unnecessary. In October 2022, Pediatric Dentistry of Albany and 12 affiliated clinics — all operated by pediatric dentist Barry L. Jacobson and his company, HQRC Management Services, LLC — reached a settlement of more than $750,000 with the New York State Attorney General’s Medicaid Fraud Control Unit and the United States Attorney’s Office for the District of New Jersey.

The state and federal investigation was spurred by a 2017 whistleblower lawsuit filed by a former manager of five of Jacobson’s upstate New York locations. The former employee alleged that staff at the clinics performed unnessary procedures, and were pressured to increase the number of patients and procedures in order to meet a $180,000-per-month revenue goal.

A spokesperson for HQRC declined to comment on specific claims from the complaint, but insisted that the settlement did not suggest that dental care provided by the company’s practitioners was inappropriate; rather, that the recordkeeping needed to support a limited number of specific procedures was lacking. “HQRC has steadfastly denied these allegations,” the spokesperson stated, adding that the company has “cooperated fully with the five-year government investigation that followed, and ultimately settled over record keeping and billing issues that occurred at a few of its offices several years ago that have long ago been addressed and corrected.”  

According to the settlement agreement, Jacobson and his company admitted that “in some instances, between 2011 and 2018, some dentists affiliated with HQRC performed and billed Medicaid for therapeutic pulpotomies not supported by the medical records maintained at the respective HQRC affiliated dental practices.”

New York state officials have not revealed the exact number of investigated procedures performed under the HQRC umbrella, and the experience of Rivera and her daughter was not, at least to Rivera’s knowledge, scrutinized as part of the lawsuit and subsequent settlement. This could mean that despite their experience, this particular “baby root canal” was medically necessary.

And according to experts who spoke to Undark, while some patients are likely to get more treatment than others, the main goal of pediatric dentistry is to promote oral hygiene, mediate pain, and keep baby teeth healthy until the adult teeth come in, said Donald Chi, a pediatric dentist and professor of oral health sciences at the University of Washington.

This persistently murky tableau of incomplete science and financial incentivizing, alongside worrying lawsuits, can cast a shadow on a whole profession, some experts say.

Still, deciding how to treat young patients in dentistry isn’t always straightforward, and the challenge is compounded by a relative lack of evidence and clinical guidance, compared to other medical research. Dentistry research is far smaller in scope and often plagued by funding biases. And while there’s good evidence that less invasive alternatives to fillings work well in kids, those alternatives haven’t been as widely adopted. Several dental experts also stressed to Undark that not every case is not the same — what might work well for one child may not work for another.

Worsening the problem, experts say there’s a strong economic incentive to focus on interventions, especially at practices that serve Medicaid or the Children’s Health Insurance Program, also called CHIP, which have exceptionally low reimbursement rates in many states. This may lead some practices to turn to private equity firms, which gives investment companies a hand in the operations of medical practice and may incentivize unnecessary treatments. (A private equity firm invested in HQRC Management. According to the plaintiff’s complaint, the practices’ revenue was mainly from Medicaid.)

This persistently murky tableau of incomplete science and financial incentivizing, alongside worrying lawsuits, can cast a shadow on a whole profession, some experts say. And it leaves patients like Rivera to wonder and worry whether their own children’s dental interventions were rooted in good-faith medical decision making, or something else entirely.


Baby teeth are, of course, temporary. And anyone who has ever tried to brush a reluctant toddler’s teeth knows firsthand that those tiny molars don’t always get high-quality home care. But their impermanence doesn’t mean that care isn’t important — if those teeth get ignored, it’s likely to cause problems with adult teeth later on.

As a specialty, pediatric dentistry is a little more than a century old. In 1909, about 70 years after the first U.S. dentistry college opened, a dentist named Minnie Evangeline Jordon established the first practice just for children. A few years later, she wrote that her male colleagues were glad to be rid of their pediatric patients “so that they could settle down to the serious work of dentistry — the making of bridges and plates.”

Today, although any dentist can treat kids, there is a thriving subspecialty of practices specializing in pediatric dentistry. There are more than 200,000 dentists in the country, about 8,000 of whom are pediatric specialists — a full-fledged discipline, with specialized training, a national professional organization, and journals like Pediatric Dentistry Journal and Journal of Clinical Pediatric Dentistry, where dentists publish their research into best practices into the field. Some of that research has bolstered longstanding claims: Regular brushing with fluoride toothpaste helps prevent cavities, early dental visits (before age four) reduce the amount of treatment needed later, and fluoride treatments such as gels, varnish, and mouth rinses may be valuable.

These measures are engaged in a sustained battle with the bacteria that create acids that corrode teeth. By physically removing stuck food that feeds the bacteria, and by strengthening the enamel with fluoride, these measures can prevent cavities and the proliferation of the decay-causing bacteria that can linger in a child’s mouth far past when their baby teeth fall out.

 

But, some experts say, it’s difficult for dentists to translate pediatric dentistry research to practice. Review articles, which evaluate a body of research on a particular subject, conclude that findings regarding pediatric dentistry have low certainty. For one thing, much of the relevant research that does exist has a high risk of bias, according to Shaun Sellars, a general dentist in Suffolk in the United Kingdom, because it is paid for by players in the industry, such as manufacturers of dental materials. Dentists “don’t do a lot of practice-based research either,” said Sellars, who is also the ethics columnist for the British Dental Journal. “There’s the funding issue there,” he added. “Because dentists, if they’re not hands in mouth, they’re not making money.”

Still, research on evidence-based practices and technology are advancing, and quickly. In dentistry schools “half of what we teach is out of date in five years,” said David Johnsen, a professor of dentistry at the University of Iowa. This can make it hard for providers to keep up with new findings. According to Sellars, many dentists face barriers to making evidence-based decisions, such as not having enough time to follow new studies or not having access to research articles behind paywalls. And even if dentists do read the literature, Sellars said, “not enough of it is relevant to what we actually do in practice.” Oftentimes, he added, “dentists will find what works for them, or what they believe works for them, and just continue to apply that.”

Recently, research has called into question common procedures used to fight cavities in kids. Evidence shows that fillings aren’t necessarily better than noninvasive alternatives, such as silver diamine fluoride, an inexpensive liquid that can slow decay, or caps that can be pushed onto the tooth (sometimes called the “Hall Technique”). Neither of these alternatives require drilling, filing down a tooth, or using anesthetics, said Nicola Innes, a professor of pediatric dentistry at Cardiff University.

Sellars lamented that there aren’t many resources, such as clinical guidelines, that would help dentists navigate the complex situations they face every day in an evidence-based way.

Dentistry decisions aren’t always straightforward. There are a wide range of approaches over how to treat dental cavities — one of the most common disease treatments in a dental office — in kids, including the kind of baby root canal that Rivera’s daughter received. As Johnsen put it: “If you get 10 really good dentists around a patient or a case and you say, ‘What’s the right treatment plan?’ you may get six or 10 or 11 different opinions.”


When a child comes in to see a dentist with a cavity, deciding how to treat a child’s cavity can be complicated, Chi told Undark. The dentist has to consider: How deep is the cavity? How much has it progressed since the patient’s last visit? Does the child appear to have regular brushing habits? Does the child have a risk factor for tooth decay? Might the tooth fall out soon?

If the cavity is not too deep and the tooth might fall out soon, the dentist might opt to do nothing and check again in six months. Or the dentist might slow the decay by painting on diamine fluoride to halt or slow decay (a downside: the material stains the tooth black).

If a dentist believes the cavity needs more intervention, many may choose fillings. “The problem with fillings is that they don’t do very well in children’s teeth,” said Innes, because baby teeth are small and wet, and kids tend to wiggle. Injecting anesthesia and drilling can also be unpleasant. There’s solid evidence, from her research and others, that fillings aren’t necessarily better than the noninvasive alternatives: silver diamine fluoride or caps.

When a cavity becomes so deep that a tooth’s pulp becomes infected, options include pulling the tooth or performing a root canal. Both have downsides, Innes said. A gap left from a pulled tooth can allow teeth to twist and migrate, which can lead to a need for orthodontia later. For a root canal, a child needs to be able to sit for a long time, first during the root canal and again when the tooth is shaved down and a crown is put on. Baby root canals come with a risk of infection, as Rivera said happened with her daughter in New York state. For instance, the Centers for Disease Control and Prevention recently issued a health advisory because multiple outbreaks of nontuberculous mycobacteria infections have occurred in children who received pulpotomies in pediatric dental clinics where the dental treatment water contained high levels of bacteria.

For many children, extensive dental work such as multiple root canals or fillings may require general anesthesia. But it’s uncomfortable to have a tooth pulled, even when a child is anesthetized and the procedure is painless, Innes said.

Anesthesia is also expensive, and it can have real risks for kids, including, in very rare cases, serious injury and death. More commonly in the short term, “they can have some attachment disorders, some night terrors, bedwetting, things like that,” said Innes. “And in the longer term, there was a very small amount of evidence that it probably doesn’t do them any good neurologically.”


Most dental treatments, several experts stressed to Undark, should be preventative. “I’d much rather spend my time telling people and helping people remain healthy than treating someone for a root canal, said Margherita Fontana, a professor at the University of Michigan School of Dentistry, adding: “They’re not having fun, and I’m not having fun. I mean, it’s not a fun thing to do to something to someone that you know is in pain.”

Unfortunately, Fontana said, there’s little data to indicate which patients are most at risk for dental disease, and how to best prevent it. “We need better prediction tools, in general, for children and for adults,” she added. “Many times, we are reactive to the damage rather than trying to prevent the damage.”

Part of the issue of prioritizing prevention, Fontana and other experts say, is an incentive system that offers few rewards for prevention-centered approaches — and large payouts for interventions.

Fontana’s research focuses on predicting dental health risks and using easy interventions like silver diamine fluoride, but generally requires routine dental visits to keep an eye on whether the cavity is progressing.

“The problem with fillings is that they don’t do very well in children’s teeth,” said Innes, because baby teeth are small and wet, and kids tend to wiggle.

“I just have happy kids sitting in the chair. I’m doing things and testing things that I think are going to be super easy, fast, and accessible,” she said. “But then I know that at the time to get translated into practice is going to be difficult, because there’s no good way for people to get reimbursed to do those things.”

When more robust research supports a particular dentistry tool or technique, there may still be financial barriers for widespread use. In many states in the U.S., less invasive treatments and preventative measures, including fluoride varnish and silver diamine fluoride, are reimbursed at a much lower rate than more invasive ones, which may make them less likely to be adopted into practices. And dentists don’t get paid at all for taking time to walk a patient through their potential treatment options. If dentists “don’t physically do something in your mouth, they do not get reimbursed,” said Fontana.

Reimbursement can be particularly difficult for dentists who accept Medicaid or the Children’s Health Insurance Program, which serve more than 41 million kids and tend to have much lower reimbursement rates than private insurance or private pay rates. While overhead costs are increasing due to inflation, data indicate that Medicaid reimbursement rates have failed to keep up. Those problems can be especially acute in practices that are under pressure from owners or investors to make cash.

“You’re fighting a system where the driver is doing something — dentists don’t get paid to prevent disease,” Fontana added. “I don’t think it’s ever going to change if the system doesn’t change.”


With low reimbursement rates for preventative measures like cleanings and fluoride applications, it’s hard to imagine how pediatric dentists earn more than general dentists. But Chi said that a key component of pediatric dentistry “is to provide high quality care as quickly as possible. And the main reason for that is that children have short attention spans.” That also means that a pediatric dentist can potentially book more patients in a day than a general dentist can, which may lead to more income.

Dentists that accept Medicaid or CHIP face other challenges in billing and running a practice. Medicaid is a joint federal-state program, but it varies from state to state, explained Jason Ray, a Texas lawyer with experience in Medicaid dentistry-related lawsuits. In addition to low reimbursement rates, some Medicaid programs also require dentists to do more paperwork than the state’s dental board generally does, such as getting consent for each visit and each procedure, which could add to administrative costs. Medicaid audits can also be time consuming.

Ideally, a dentist would have a mix of patients, some who pay with private insurance, others out-of-pocket, and some Medicaid patients. However, dentists often don’t achieve a good balance. Research shows that dentists who treat more Medicaid patients are more likely to be located in a majority non-White zip code, a rural area, or high-poverty zip code. Because of Medicaid’s low reimbursement rates, Ray pointed out, one way for a dentist to make money is to see a high number of patients and do a large number of procedures.

There’s no doubt that this could lead to incentives to do procedures that may not be necessary, Ray said. An analysis of California’s Medicaid program in 2012 indicated that about 8 percent of dentists reviewed that provided Medicaid services to children met certain thresholds for questionable billing. The average general dentist performs root canals on 5 percent of pediatric patients. In the sample reviewed, the threshold of questionable billing was 18 percent, which about 2 percent of the Medicaid dentists exceeded.

A 2022 analysis of dentists found that about 33 percent treat at least one Medicaid patient. Those that do may also be tempted by the offers of private equity firms, which can lead to big payouts, but might also encourage practices to prioritize profits over evidence-based care. (Firms often don’t pay penalties in cases of fraud.) A 2013 report prepared by a U.S. Senate committee noted that corporate-managed “clinics tend to focus on low-income children eligible for Medicaid. However, these clinics have been cited for conducting unnecessary treatments.”

Whether Rivera’s daughter’s procedure was one of those unnecessary treatments is something that she and her family may never truly know. But she told Undark that the experience has left her rattled — even though she and her daughter, now 13, have found a Medicaid-accepting dental practice that they say they’re generally happy with.

Still, Rivera says that ever since her daughter received that “baby root canal” six years ago, she has deeply hated going to the dentist. “She remembers that day,” Rivera said, “very clearly.”


Christina Szalinski is a freelance science writer with a Ph.D. in cell biology based near Philadelphia.

This article was originally published on Undark. Read the original article.

Medicine photo

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FDA approves first fecal transplant pill https://www.popsci.com/health/fda-approves-first-fecal-transplant-pill/ Thu, 27 Apr 2023 15:00:00 +0000 https://www.popsci.com/?p=537259
A lab technician in a glove swabs a circular petri dish.
Healthy bacteria found in human waste can help fight dangerous infections in the gut. Deposit Photos

The new treatment is simpler and less invasive than other transplants.

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A lab technician in a glove swabs a circular petri dish.
Healthy bacteria found in human waste can help fight dangerous infections in the gut. Deposit Photos

On April 26, the Food and Drug Administration approved the first pill for fecal transplants. The pill is made from healthy bacteria found in human waste which can help fight dangerous infections in the gut.

[Related: The FDA approved a fecal transplant treatment for the first time.]

According to the FDA, the pill from Massachusetts-based Seres Therapeutics provides doctors and patients with a simpler, and rigorously tested version of the procedure that has been used for just over a decade. Previously, when a patient experienced a Clostridium difficile infection or CDI, doctors would perform a fecal transplant using the stool from a healthy donor. Donor bacteria can help restore the balance of bacteria in the gut and prevent reinfections.  

The new treatment will be sold under the brand name Vowst as four daily capsules for three consecutive days. Vowst was cleared for adults 18 and older who face risks from repeat infections from C. diff, and have already received antibiotic treatment. A CDI can cause severe nausea, cramping, and diarrhea, and is dangerous when it reoccurs. CDI’s lead to roughly 15,000 to 30,000 deaths per year

While C. diff can be killed with antibiotics, the drugs can also destroy the beneficial bacteria that live inside the gut, leaving  it more susceptible to infections in the future. People over age 65 are at an increased risk for contracting an infection, but other risk factors include hospitalization, a weakened immune system, and a previous history of infection. Some patients may get the infection again following recovery, and the risk of additional recurrences increases with each infection. 

The FDA approved Vowst based on a study of 180 patients wherein nearly 88 percent of the patients taking the capsules did not experience a reinfection after eight weeks. About 60 percent of those who received dummy pills did see a reinfection. Some of the common side effects included abdominal swelling, constipation and diarrhea.

According to Seres, via reporting from the Associated Press, manufacturing the pills relies on the same techniques and equipment that is used to purify both blood products and other biologic therapies. It starts with stool from a screened group of donors that is tested for potential infections, viruses, and parasites. The samples are then processed to remove the waste and isolate the healthy bacteria,killing any lingering organisms. 

In the approval announcement, the FDA warned that the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens.”

[Related: What to know about fecal transplants in the wake of the first death.]

In late 2022, the FDA approved Rebyota, the first pharmaceutical-grade version of a fecal transplant treatment from Ferring Pharmaceuticals. This product must be delivered via the rectum. 

The approvals of both Rebyota and Vowst are the product of years of pharmaceutical research into the bustling community of fungi, bacteria, and viruses that lives in the gut called the microbiome.

A network of stool banks from hospitals and medical institutions across the US have provided most fecal transplants. However, that growing number of fecal transplant practitioners and stool banks around the US has created a regulatory mess for the FDA, since the agency doesn’t traditionally regulate medical procedures performed by doctors. As long as stool donors are carefully screened for any potential infectious diseases, the FDA has rarely intervened in using the procedure.

In response to these new FDA-approved options, the largest stool bank in the US called OpenBiome said it will keep serving the patients like children and adults with treatment-resistant cases who are not eligible for the new treatments. Since 2013, OpenBiome has supplied more than 65,000 stool samples for CDI patients.

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That melatonin gummy might be stronger than you need https://www.popsci.com/health/melatonin-gummy-labels-fda/ Wed, 26 Apr 2023 20:00:00 +0000 https://www.popsci.com/?p=536917
A woman just waking up in bed turns off an analog alarm clock.
Most of the products tested in a new study had 20, 30, or 50 percent more melatonin than the quantity listed on the label. Deposit Photos

A new study found that most of the sampled dietary supplements were mislabled.

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A woman just waking up in bed turns off an analog alarm clock.
Most of the products tested in a new study had 20, 30, or 50 percent more melatonin than the quantity listed on the label. Deposit Photos

Roughly 55,000 adult consumers in the United States  take popular chewy melatonin gummies to promote better sleep. But they may be getting a little more of the hormone than the label indicates. A study published April 25 as a letter in the Journal of the American Medical Association (JAMA) found that 88 percent of tested supplements were mislabeled.

The study follows a Centers for Disease Control and Prevention (CDC) report from last year about an alarming surge of excessive pediatric infestations of melatonin over the past 10 years.

[Related: Yes, you can overdose on melatonin. Here’s how to use the sleep supplements safely.]

Melatonin is a hormone naturally produced deep within the brain in the pineal gland. It  is released into the bloodstream to regulate the body’s natural sleep cycles. Melatonin is considered a drug in some countries in the European Union, Japan, Canada, and the United Kingdom, making it only available through a prescription. The US Food and Drug Administration considers melatonin a dietary supplement, but manufacturers are not required to receive FDA approval or provide safety data on melatonin products.

For this study, a team of researchers from Cambridge Health Alliance in Massachusetts and the University of Mississippi tested 25 different supplements. According to the authors, the team selected the first 25 gummy melatonin products that displayed on the National Institutes of Health database for this study. The team dissolved the gummies and then measured the quantity of melatonin, cannabidiol (CBD), and other components in the supplements.

Most of the products tested had 20, 30, or 50 percent more melatonin than the quantity listed on the label. Four has less amounts of the hormone than promised, including one without any detectable levels of melatonin. 

Twenty-two were “inaccurately labeled,” meaning they contained 10 percent more or less than the amount of melatonin on the label. 

Five products listed CBD as an ingredient, but they all had slightly higher levels of CBD than indicated on the label. According to the FDA, “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”

[Related: The science behind our circadian rhythms, and why time changes mess them up.]

“One product contained 347 percent more melatonin than what was actually listed on the label of the gummies,” study co-author and professor of medicine at the Cambridge Health Alliance Pieter Cohen told CNN.

In response to the JAMA letter, Steve Mister, the president and chief executive of the Council for Responsible Nutrition, told The Washington Post that supplement companies are required to have “at least 100 percent of labeled dosage” in their products. “It’s not uncommon for companies to put in a little extra,” he added. “So, for instance, a melatonin product that’s labeled as 3 milligrams might put in 4 milligrams.” 

Melatonin was the most cited substance in calls about children to US poison control centers in 2020. Drowsiness, headaches, agitation, and increased bed-wetting or urination in the evening hours are all potential side effects of melatonin use in children. 

“It’s important, especially in kids, not to use melatonin until you’ve spoken with your pediatrician or your sleep doctor,” M. Adeel Rishi, a pulmonology, sleep medicine, and critical care specialist in Indiana and vice chair of the American Academy of Sleep Medicine Public Safety Committee, told PopSci last July. “The dose recommended in children is significantly lower than what is recommended in adults, and if you take too much of anything you have an overdose. Although it’s come to attention really in the last couple of years, we know that cases of melatonin among children have been on an upswing even before the pandemic.”

Other pediatric sleep experts stress the importance of good sleep hygiene and habits before starting melatonin. The new study’s letter also included a warning to parents that giving the gummies to children could result “in ingestion of unpredictable quantities” of melatonin.

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6 Ozempic facts that make sense of social media hype https://www.popsci.com/health/how-does-ozempic-work/ Wed, 26 Apr 2023 19:30:00 +0000 https://www.popsci.com/?p=536852
Ozempic injectable diabetes drug, which causes weight loss
It's important to know how Ozempic really works, and what the side effects are. Joel Saget/AFP via Getty Images

What you should know about so-called weight loss drugs, lizard lips, and more.

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Ozempic injectable diabetes drug, which causes weight loss
It's important to know how Ozempic really works, and what the side effects are. Joel Saget/AFP via Getty Images

A common diabetes drug has become trendy because of its use as an off-label weight loss drug. From tech moguls to influencers, this drug has become the latest “celebrity secret” for shedding the pounds. 

Ozempic, and a similar medication called Wegovy, are brand names for an injectable medicine called semaglutide. This drug is the synthetic version of a hormone called glucagon-like peptide-1 (GLP-1), which belongs to a class of medications known as GLP-1 agonists

The chemistry explains how Ozempic works and what its main side effects are. GLP-1 is a compound that increases insulin production and lowers blood sugar. After we eat, GLP-1 also signals to the brain a feeling of fullness. Meanwhile, GLP-1 agonists slow down the rate at which food empties out of the stomach, further promoting a feeling of satiety. This prevents cravings and overeating, which can result in weight loss

While Ozempic and Wegovy are now lumped together with weight loss fads, these medications are not diet hacks. Instead, they are medications proven to lower weight in certain patient populations. 

Despite this, there is a growing concern that these drugs are misused and overprescribed in individuals who casually use them for aesthetic reasons. There’s concern this type of use is resulting in repercussions like unmanaged side effects and drug shortages. Here are some proven facts and common misconceptions surrounding Ozempic. 

Fact: Ozempic’s side effects include weight loss, but it’s not a weight loss drug

This distinction is important. Ozempic is only approved by the Food and Drug Administration (FDA) for Type 2 diabetes. It is intended to help diabetes patients control their blood sugar. While it is not a weight loss drug, diabetes patients on Ozempic may lose weight as a side effect because of the way the medication works. Losing weight can improve insulin production and, in turn, benefit some individuals. Meanwhile, Wegovy is FDA-approved for chronic weight management in adults with obesity.

[Related: There’s still a lot we don’t know about the new generation of weight loss pills.]

Swetha Bhat, a primary care physician in the California Bay Area, prescribes Ozempic and Wegovy to patients who meet the criteria. She tells PopSci she has denied requests for semaglutide for weight loss because patients don’t qualify. 

“I can’t prescribe medications to someone who doesn’t meet the FDA indication,” Bhat says. “There are med spa clinics run by dermatologists or plastic surgeons who prescribe semaglutide and that is simply out of scope for their practice.”

Fact: Ozempic and Wegovy are the same medication

Ozempic and Wegovy are two names for the same injectable drug manufactured by Novo Nordisk: semaglutide. But they are approved for different conditions and administered at different dosages.

Ozempic first received FDA approval as a treatment for type 2 diabetes in 2017 at a maximum dosage of 1 milligram once weekly, and was approved again in 2022 for a larger maximum dose of 2.0 milligrams

Wegovy received FDA approval in 2021 for adults who are obese or overweight with at least one weight-related condition (high blood pressure, type 2 diabetes, or high cholesterol). People taking Wegovy start at a dose of 0.25 milligrams once a week and increase the dose every four weeks until they reach the full dose of 2.4 milligrams.

Despite the recent Wegovy approval, there’s already a new drug on the block, which seemingly packs even more punch. In 2022, Eli Lilly launched its first in-class diabetes drug called Mounjaro (generic name tirzepatide), which activates both GLP-1 and GIP receptors for increased blood glucose control. According to the FDA, the average weight loss on Mounjaro at the maximum dose is 12 pounds more than with semaglutide. 

Mounjaro injectable diabetes drug, which causes weight loss
Mounjaro could be the next misappropriated weight loss fad. Sandy Huffaker for The Washington Post via Getty Images

Fact: Ozempic has other side effects, but they’re not the same for everyone

There are some reports that Ozempic use results in a side effect called “Ozempic face,” in which the face becomes noticeably more gaunt and sunken due to the drastic weight loss. 

[Related: Experts rank the raw food diet as the worst of 2023.]

However, the term “Ozempic face” is misleading. It’s not necessarily a side effect of Ozempic, but a general possible side effect of weight loss. Sometimes a large weight reduction can result in excess skin in the face among other places. But not everyone who uses Ozempic will experience this, and it’s not a clinically proven side effect.

The most common side effects of taking GLP-1 agonists are nausea and diarrhea. Another common side effect is lack of appetite, to the point where some patients need to remind themselves to eat.

Fact: The Ozempic shortage was caused by the weight loss fad—and many other reasons 

There are several reasons for the Ozempic shortage. Novo Nordisk stated the shortage was due to issues with manufacturers coupled with the increase in demand for both on-label and off-label use. Pharmacies also tend to not stock Ozempic as it is expensive with poor cost-benefit. 

Meanwhile, social media increased interest in semaglutide among people who wouldn’t qualify for the drug for FDA-approved reasons. For example, a TikTok of Chelsea Handler went viral after she was unknowingly given Ozempic by her “anti-aging doctor.” This is referred to as “off-label” prescribing—when a doctor uses their best judgment to prescribe a medication for which the drug isn’t FDA approved.

[Related: Weight might not be the best way to detect diabetes early.]

Digital health companies, meanwhile, have made it easy for people who want the drug to access it. This has contributed to drug shortages.

A retail pharmacist in Central California, who did not want their name published, spoke about the opposite end of the experience with PopSci. “At first we were getting an influx of patients who were diabetic and we saw how much it helped. Then all of a sudden there was a surge of non-diabetic patients and we could not get semaglutide for our diabetic patients.”

Now, most practitioners have to provide a diabetes diagnosis when prescribing Ozempic for insurance reasons, they explain. “At the same time, the supply chain was also a major contributor to the shortage. For a while, we couldn’t get the drug at all through McKesson [a drug distributor] and our diabetes patients suffered. We had to switch them to Trulicity [the brand name for the drug dulaglutide] and even that went out of stock for a while.”

Fact: Ozempic is made from lizard lips (kind of)

In a recent episode of the pop culture podcast “Psychobabble,” hosted by Tyler Oakley and Korey Kuhl, the duo giggled in wonderment after reading on Twitter that Ozempic was made from “Gila monster spit.” 

GLP-1 agonists are derived from the venomous saliva of the Gila monster, a giant lizard that lives in US and Mexican deserts. In 1990, an endocrinologist named John Eng researched both the toxic and nontoxic chemicals produced by the species for medicinal use. He discovered that Gila monsters went long periods without eating and slowed down their metabolism while maintaining constant blood sugar levels. 

The peptide that allows them to do this is called Exendin-4 and is strikingly similar in both structure and function to human GLP-1. So Exendin-4 was derived to make the first synthetic GLP-1 drug, called Exenatide.

Fact: Ozempic can be a life-changing medication for the right patients

GLP-1 agonists, including Ozempic, continuously prove to be powerful blood glucose and weight-lowering medicines. They are also one of the few classes of diabetes drugs that have a significant clinical benefit in patients with a cardiovascular disease history and chronic kidney disease, which are risk factors for diabetes. 

With so many headlines and news outlets, the amount of information the average individual has to filter through can be overwhelming, especially when it comes to health. The Ozempic craze is a fantastic example of pop culture amplifying potentially misleading information. It is important to weed out the fact from fodder to avoid an unwarranted bias against a possible life-saving medication for the right candidate.

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New therapies offer hope for patients with rare genetic conditions https://www.popsci.com/health/haploinsufficiency-diseases-gene-therapy/ Wed, 26 Apr 2023 01:00:00 +0000 https://www.popsci.com/?p=536493
Sodium channel protein production.
Sodium channel protein production.

Haploinsufficiencies are hard to tackle with traditional gene therapy. But new approaches are in the works.

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Sodium channel protein production.
Sodium channel protein production.

This article originally appeared in Knowable Magazine.

The seizures started when Samantha Gundel was just four months old. By her first birthday, she was taking a cocktail of three different anticonvulsant medicines. A vicious cycle of recurrent pneumonia, spurred on by seizure-induced inhalation of regurgitated food, landed the young toddler in and out of the hospital near her Westchester County home in New York State.

Genetic testing soon confirmed her doctors’ suspicions: Samantha, now age 4, has Dravet syndrome, an incurable form of epilepsy. Her brain was misfiring because of a mutation that is unlike those responsible for most genetic diseases; it’s a type that has long eluded the possibility of correction. Available drugs could help alleviate symptoms, but there was nothing that could address the root cause of her disease.

That’s because the mutation at the heart of Dravet creates a phenomenon known as haploinsufficiency, in which a person falls ill if they have only a single working copy of a gene. That lone gene simply can’t produce enough protein to serve its molecular purpose. In the case of Dravet, that means that electrical signaling between nerve cells gets thrown out of whack, leading to the kinds of neuronal shock waves that trigger seizures.

Most genes are not like this. Though the human genome contains two copies of almost every gene, one inherited from each parent, the body can generally do fine with just one.

Not so for genes such as SCN1A, the main culprit behind Dravet. For SCN1A and hundreds of other known genes like it, there’s a delicate balance of molecular activity that is needed to ensure proper function. Too little activity is a problem — and oftentimes, so is too much.

This Goldilocks paradigm partially explains why conventional gene therapy strategies are ill-suited to the task of haploinsufficiency correction. With therapies of this kind — several of which are now available to treat “recessive” genetic diseases such as the blood disorder beta thalassemia and a form of inherited vision loss — the amount of protein made by an introduced gene just needs to cross a minimum threshold to undo the disease process.

In those contexts, it’s not a problem if the added gene is overactive — there’s a floor, but no ceiling, to therapeutic protein levels. That is simply not the case with many dosage-sensitive diseases like Dravet, especially for brain disorders in which too much protein can overexcite neuronal activity, says Gopi Shanker, who served as chief scientific officer of Tevard Biosciences in Cambridge, Massachusetts, until earlier this year. “That’s what makes it more challenging,” he says.

Adding to the challenge: The special types of modified viruses that are used to ferry therapeutic genes into human cells can handle only so much extra DNA — and the genes at the heart of Dravet and many related haploinsufficiency disorders are much too big to fit inside of these delivery vehicles.

Overlooked no more

Faced with these technical and molecular hurdles, the biotechnology industry long ignored haploinsufficiencies. For more than 30 years, companies jostled to get a piece of the drug development action in other areas of rare genetic disease — for cystic fibrosis, say, or for hemophilia — but conditions like Dravet got short shrift. “It’s one of the most neglected classes of disorder,” says Navneet Matharu, cofounder and chief scientific officer of Regel Therapeutics, based in Berkeley, California, and Boston.

Not anymore. Thanks to new therapeutic ideas and a better understanding of disease processes, Regel, Tevard and a group of other biotech startups are taking aim at Dravet, with experimental treatments and technologies that they say should serve as testing grounds for going after haploinsufficiency diseases more broadly.

Currently, there’s little to offer patients with these maladies other than drugs to aid with symptom control, says Kenneth Myers, a pediatric neurologist at Montreal Children’s Hospital who cowrote an article about emerging therapies for Dravet and similar genetic epilepsies in the 2022 issue of the Annual Review of Pharmacology and Toxicology. But thanks to new advances, he says, “there’s a huge reason for optimism.”

Samantha, for one, now seems to have her disease under control because of a drug called STK-001; it is the first ever to be evaluated clinically that addresses the root cause of Dravet.

Between February and April 2022, doctors thrice inserted a long needle into the young girl’s lower spine and injected the investigational therapy, which is designed to bump up levels of the sodium-shuttling protein whose deficiency is responsible for Dravet. It seemed to work. For a time, Samantha lived nearly seizure-free — presumably because the increased protein levels helped correct electrical imbalances in her brain.

Conventional gene therapy strategies are ill-suited to the task of haploinsufficiency correction.

She went from epileptic attacks every 7 to 10 days, on average, to nothing for months on end. Her verbal skills improved, as did her physical capabilities. Her gait improved and her tremors disappeared.

Eventually, as the therapy wore off, Samantha began to backslide, with seizures returning every couple of weeks or so. But she started receiving additional doses of STK-001 under a new trial protocol in October 2022, and since then has experienced only two epileptic episodes over the span of six months. “It’s really pretty amazing,” says her mother, Jenni Barnao.

“Is it a cure? No.… But this is absolutely our best shot,” Barnao says. “There’s definitely something with this drug that’s very good. Her brain is just working better.”

Give a boost

The STK-001 treatment relies on the fact that the normal activity of genes is somewhat inefficient and wasteful. When genes get decoded into mRNA, the resulting sequences require further cutting and splicing before they’re mature and ready to serve as guides for making protein. But often, this process is sloppy and doesn’t result in usable product.

Which is where STK-001 comes in.

A kind of “antisense” therapy, STK-001 consists of short, synthetic pieces of RNA that are tailor-made to stick to part of the SCN1A gene transcript and, as a result, make productive cutting and splicing more efficient. The synthetic pieces glom on to mRNA from the one working version of the gene that people with Dravet have and help to ensure that unwanted bits of the mRNA sequence are spliced out, just as a movie editor might cut scenes that detract from a film’s story. As a result, more functional ion channel protein gets made than would otherwise happen.

Diseases photo

Protein levels don’t get completely back to normal. According to mouse studies, there’s a 50 percent to 60 percent boost, not a full doubling of the relevant protein in the brain. But that bump seems to be enough to make a real impact on patients’ lives.

Stoke Therapeutics, the company in Bedford, Massachusetts, that is behind STK-001, reported at the American Epilepsy Society’s 2022 Annual Meeting that 20 of the first 27 Dravet patients to receive multiple doses of the therapy in early trials experienced reductions in seizure frequency. The greatest benefits were observed among young children like Samantha whose brains have accumulated less damage from years of debilitating seizures and abnormal cell function. Larger confirmatory trials that could lead to marketing approval are scheduled to begin next year.

Stoke is hardly alone in its quest to fix Dravet and haploinsufficiency disorders more generally. Several other biotech startups are nearing clinical trials with their own technological approaches to enhancing what working gene activity remains. Encoded Therapeutics, for example, will soon begin enrolling participants for a trial of its experimental Dravet therapy, ETX-001; it uses an engineered virus to deliver a protein that ramps up SCN1A gene activity so that many more mRNA copies are made of the single, functional gene.

And if any of these companies succeed in reversing the course of Dravet, their technologies could then be adapted to take on any comparable disease, says Orrin Devinsky, a neurologist at NYU Langone Health who works with several of the firms and is involved in Samantha’s care. “An effective therapy would provide a potential platform to address other haploinsufficiencies,” he says.

Diseases photo
Companies are working on a variety of approaches for treating Dravet syndrome. The same methods could be applied to other haploinsufficiency diseases. Source: Reported by E. Dolgin

New targets, new tactics

Stoke will soon put that idea to the test.

Buoyed by the early promise of its Dravet therapeutic, the company developed a second drug candidate, STK-002, that similarly targets splicing to turn nonproductive gene transcripts into constructive ones. But in this case, it’s designed to tackle an inherited vision disorder known as autosomal dominant optic atrophy, caused by haploinsufficiency of a gene called OPA1. In this disease, a single working copy of OPA1 is not enough to sustain proper nerve signaling from the eyes to the brain.

Clinical evaluation of STK-002 is expected to start next year. Meanwhile, in partnership with Acadia Pharmaceuticals of San Diego, Stoke is also exploring treatments for Rett syndrome and SYNGAP1-related intellectual disability, both severe brain disorders caused by insufficient protein levels.

“There’s definitely something with this drug that’s very good. Her brain is just working better.”

Jenni Barnao

Stoke’s splice-modulating approach flows naturally from the success of another antisense drug, Spinraza. Developed by Ionis Pharmaceuticals in collaboration with Biogen, Spinraza also works on splicing of mRNA transcripts to promote production of a missing protein. In 2016, it became the first therapy approved for treating a rare neuromuscular disorder called spinal muscular atrophy (SMA).

SMA is somewhat different, though. It isn’t a haploinsufficiency — it occurs when both gene copies are defective, not just one — but it’s an unusual disease from a genetics standpoint. Because of a quirk in the human genome, it turns out that people have a kind of backup gene that doesn’t normally function because its mRNA undergoes faulty splicing. With Spinraza acting as a guide to help the mRNA splice correctly, that backup gene can be made operational and do the job that the damaged gene copies can’t do.

Few diseases are like this. But Stoke’s scientific cofounders, molecular geneticist Adrian Krainer of Cold Spring Harbor Laboratory in New York (who helped to develop Spinraza) and his former postdoctoral researcher Isabel Aznarez, realized that there was a whole world of other ailments — haploinsufficiencies — for which this type of splice modulation could be beneficial.

Spinraza was the prototype. Stoke’s portfolio is full of the next-generation editions. “We brought it to the next level,” says Aznarez, who now serves as head of discovery research at Stoke.

Striking a balance

There was a time when Dravet researchers were more focused on traditional gene replacement therapies. They aimed to insert a working version of the SCN1A gene into the genome of a virus and then introduce the engineered virus into brain cells. The problems proved manifold, though.

For starters, the virus vehicles generally used in gene therapy strategies — adeno-associated viruses (AAVs) — are too small to hold all 6,030 of the DNA letters that constitute the SCN1A gene sequence.

Researchers tried a few potential workarounds. At University College London, for example, gene therapist Rajvinder Karda and her colleagues split the SCN1A gene in half and delivered both parts into mice in different virus carriers. And at the University of Toronto, neuroscientist David Hampson and his group tried introducing a smaller gene that would fit in a single AAV vector and compensate for the SCN1A deficiency in an indirect way.

But none of those efforts advanced past mouse experiments. And while it is technically feasible to deliver the entire SCN1A gene into cells if you use other kinds of viral vectors, as researchers at the University of Navarra in Spain showed in mice, those viruses are generally considered unsafe for use in people.

To get protein levels just right, scientists say, it is best to follow the cell’s own lead.

What is more, even if gene replacement could be made to work, there are many reasons to think it would not be ideal for diseases like Dravet in which the underlying defect is mediated by an imbalance of protein levels. The amount of protein produced by those kinds of gene therapies can be unpredictable, and so are the types of cells that end up manufacturing the proteins.

To get protein levels just right, scientists say, it is best to follow the cell’s own lead, tapping into the ways that it naturally produces the protein of interest only in certain tissues of the body, and then providing a therapeutic nudge to aid the process along.

CAMP4 Therapeutics, for example, is using antisense therapies, like Stoke. But instead of targeting the splicing of gene transcripts, CAMP4’s drugs are directed at regulatory molecules that act like rheostats to control how much of those transcripts are made in the first place. By blocking or stabilizing different regulatory molecules, the company claims it can ramp up the activity of target genes in a precise and tunable way.

“It’s basically teaching the body to do it a little bit better,” says Josh Mandel-Brehm, president and CEO of CAMP4, which is based in Cambridge, Massachusetts.

In theory, the gene-editing technology known as CRISPR could obviate the need for all of these therapeutic approaches. Gene editing allows you to perfectly correct a mistake in a gene — so one could edit a faulty DNA sequence to correct it and render kids with Dravet or some other haploinsufficiency disease as good as new.

But the technology is nowhere near ready for prime time. (Some of the first CRISPR therapies to be tested in children have failed to demonstrate much benefit.) Plus, any gene-correction therapy would have to be tailored to the unique nature of a given patient’s mutations — and there are more than 1,200 Dravet-causing mutations in the SCN1A gene alone.

That’s why Jeff Coller, an RNA biologist at Johns Hopkins University and a scientific cofounder of Tevard, prefers therapeutic strategies that can address all manner of disease-causing alterations in a gene of interest, as most companies are doing now. “Having a mutation-agnostic technology is a way of going after the entire cohort of patients,” he says.

“We’re open to any approach that would help our daughters.”

Daniel Fischer

Tevard, whose mission is to “reverse” Dravet syndrome (the company’s name is Dravet spelled backward), is approaching this challenge in various ways. Some involve engineered versions of other RNAs that are key for protein production; known as “transfer” RNAs, they help to ferry amino acid building blocks to the growing protein strands. Others are intended to help bring beneficial regulatory molecules to sites of SCN1A gene activity.

But all of Tevard’s therapeutic candidates remain at least a year away from clinical testing, whereas STK-001 is in human trials today. So the company’s chief executive, Daniel Fischer — who, along with board chair and cofounder Warren Lammert, has a daughter affected by Dravet — is considering enrolling his child, now 13, in the Stoke trial rather than waiting for his own company’s efforts to bear fruit.

“We’re open to any approach that would help our daughters,” Fischer said over lunch last November at the company’s headquarters.

“And help people with Dravet generally,” added Lammert. “We’d love to see many of these things succeed.”

Editor’s note: This article was amended on April 14, 2023, to correct Gopi Shanker’s relationship with Tevard Biosciences. Shanker is Tevard’s former chief scientific officer; he is now chief scientific officer with Beam Therapeutics.

This article originally appeared in Knowable Magazine, an independent journalistic endeavor from Annual Reviews. Sign up for the newsletter.

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