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Medicine

First Person To Receive a Genetically Modified Pig Kidney Transplant Dies (npr.org) 25

An anonymous reader quotes a report from CBS News: Richard "Rick" Slayman, the first human to receive a genetically modified pig kidney transplant, has died almost two months after the procedure. Slayman, who had end-stage kidney disease, underwent the transplant in March at Massachusetts General Hospital in Boston at age 62. The hospital said in a statement on Saturday that there was "no indication" that his death was the result of the transplant. The transplant surgeon had said he hoped the transplant would function for at least two years.

"The Mass General transplant team is deeply saddened at the sudden passing of Mr. Rick Slayman," read the hospital statement. "Mr. Slayman will forever be seen as a beacon of hope to countless transplant patients worldwide and we are deeply grateful for his trust and willingness to advance the field of xenotransplantation." The surgery was a milestone for the field of xenotransplantation -- the transplant of organs from one species to another -- as a way to alleviate the organ shortage for people who need transplants. The effort to genetically modify animal organs is in hopes that the human body will not reject the foreign tissue.
NPR notes that there are more than 100,000 people in the U.S. on the waitlist for organs.
Medicine

Could Stem Cells One Day Cure Diabetes? (medscape.com) 42

Brian Shelton's type 1 diabetes was treated with an infusion of insulin-producing pancreas cells (grown from stem cells). In 2021, the New York Times reported: Now his body automatically controls its insulin and blood sugar levels. Shelton, now 64, may be the first person cured of the disease with a new treatment that has experts daring to hope that help may be coming for many of the 1.5 million Americans suffering from Type 1 diabetes. "It's a whole new life," Shelton said. Diabetes experts were astonished but urged caution. The study is continuing and will take five years, involving 17 people with Type 1 diabetes.
"By fall 2023, three patients, including Shelton, had achieved insulin independence by day 180 post-transplant," MedScape reported (in January of 2024): In the phase 1/2 study, 14 patients with type 1 diabetes and impaired hypoglycemia awareness or recurrent hypoglycemia received portal vein infusions of VX-880 [Vertex Pharmaceutical's pancreatic islet cell replacement therapy] along with standard immunosuppression. As of the last data cut, all 14 patients demonstrated islet cell engraftment and production of endogenous insulin. After more than 90 days of follow-up, 13 of the patients have achieved A1c levels < 7% without using exogenous insulin.
Brian Shelton and another patient died, and while Vertex says their deaths were unrelated to the treatment, they have "placed the study on a protocol-specified pause, pending review of the totality of the data by the independent data monitoring committee and global regulators." (MedScape adds that Vertex "is continuing with a phase 1/2 clinical trial of a different product, VX-264, which encapsulates the same VX-880 cells in a device designed to eliminate the need for immunosuppression.")

And meanwhile, a new study in China (again using stem cell-derived islet tissue) has provided "encouraging evidence that islet tissue replacement is an effective cure for diabetic patients," the researchers wrote in Nature. The treatment was administered to 59-year-old, type-2 diabetic.

"Marked changes in the patient's glycemic control were observed as early as week 2," the researchers write, and after week 32, the patient's Time In Tight Range (TITR) "had readily reached 99% and was maintained thereafter."

Thanks to long-time Slashdot reader hackingbear for sharing the news.
Medicine

The Most Detailed 3D Reconstruction of Human Brain Tissue (interestingengineering.com) 25

An anonymous reader quotes a report from Interesting Engineering: Imagine exploring the intricate world within a single cubic millimeter of human brain tissue. It might seem insignificant, but within that tiny space lies a universe of complexity -- 57,000 individual cells, 230 millimeters of blood vessels, and a staggering 150 million synapses, the junctions where neurons communicate. All this information translates to a mind-boggling 1,400 terabytes of data. That's the kind of groundbreaking achievement researchers from Harvard and Google have just accomplished.

Leading the charge at Harvard is Professor Jeff Lichtman, a renowned expert in brain structure. Partnering with Google AI, Lichtman's team has co-created the most detailed 3D reconstruction of a human brain fragment to date. This intricate map, published in Science, offers an unprecedented view of the human temporal cortex, the region responsible for memory and other higher functions. Envision a piece of brain tissue roughly half the size of a rice grain but magnified to reveal every cell and its web of neural connections in vivid detail. This remarkable feat is the culmination of nearly a decade of collaboration between Harvard and Google. Lichtman's expertise in electron microscopy imaging is combined with Google's cutting-edge AI algorithms. [...]

The newly published map in Science reveals previously unseen details of brain structure. One such discovery is a rare but powerful set of axons, each connected by up to 50 synapses, potentially influencing a significant number of neighboring neurons. The team also encountered unexpected structures, like a small number of axons forming intricate whorls. Since the sample came from a patient with epilepsy, it's unclear if these formations are specific to the condition or simply uncommon occurrences.

Medicine

Neuralink's First Implant Partly Detached From Patient's Brain (theguardian.com) 107

Ancient Slashdot reader jd shares a report from The Guardian: Neuralink's first attempt at implanting its chip in a human being's skull hit an unexpected setback after the device began to detach from the patient's brain, the company revealed on Wednesday. The patient, Noland Arbaugh, underwent surgery in February to attach a Neuralink chip to his brain, but the device's functionality began to decrease within the month after his implant. Some of the device's threads, which connect the miniature computer to the brain, had begun to retract. Neuralink did not disclose why the device partly retracted from Arbaugh's brain, but stated in a blog post that its engineers had refined the implant and restored functionality.

The decreased capabilities did not appear to endanger Arbaugh, and he could still use the implant to play a game of chess on a computer using his thoughts, according to the Wall Street Journal, which first broke the news of the issue with the chip. The possibility of removing the implant was considered after the detachment came to light, the Journal reported. [...] Arbaugh praised the implant during a demonstration in March and said that it had "already changed his life," while also stating that it had not been perfect and they "have run into some issues."

Medicine

AstraZeneca To Withdraw COVID Vaccine Globally as Demand Dips (reuters.com) 83

AstraZeneca said on Tuesday it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a "surplus of available updated vaccines" since the pandemic. From a report: The company also said it would proceed to withdraw the vaccine Vaxzevria's marketing authorizations within Europe. "As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. According to media reports, the Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.
Medicine

Study Suggests Genetics as a Cause, Not Just a Risk, for Some Alzheimer's (nytimes.com) 12

Pam Belluck reports via the New York Times: Scientists are proposing a new way of understanding the genetics of Alzheimer's that would mean that up to a fifth of patients would be considered to have a genetically caused form of the disease. Currently, the vast majority of Alzheimer's cases do not have a clearly identified cause. The new designation, proposed in a study published Monday, could broaden the scope of efforts to develop treatments, including gene therapy, and affect the design of clinical trials. It could also mean that hundreds of thousands of people in the United States alone could, if they chose, receive a diagnosis of Alzheimer's before developing any symptoms of cognitive decline, although there currently are no treatments for people at that stage. The new classification would make this type of Alzheimer's one of the most common genetic disorders in the world, medical experts said.

"This reconceptualization that we're proposing affects not a small minority of people," said Dr. Juan Fortea, an author of the study and the director of the Sant Pau Memory Unit in Barcelona, Spain. "Sometimes we say that we don't know the cause of Alzheimer's disease," but, he said, this would mean that about 15 to 20 percent of cases "can be tracked back to a cause, and the cause is in the genes." The idea involves a gene variant called APOE4. Scientists have long known that inheriting one copy of the variant increases the risk of developing Alzheimer's, and that people with two copies, inherited from each parent, have vastly increased risk.

The new study, published in the journal Nature Medicine, analyzed data from over 500 people with two copies of APOE4, a significantly larger pool than in previous studies. The researchers found that almost all of those patients developed the biological pathology of Alzheimer's, and the authors say that two copies of APOE4 should now be considered a cause of Alzheimer's -- not simply a risk factor. The patients also developed Alzheimer's pathology relatively young, the study found. By age 55, over 95 percent had biological markers associated with the disease. By 65, almost all had abnormal levels of a protein called amyloid that forms plaques in the brain, a hallmark of Alzheimer's. And many started developing symptoms of cognitive decline at age 65, younger than most people without the APOE4 variant.

Medicine

FDA Qualifies Apple Watch's AFib History For Use In Clinical Studies 16

In a first for "digital health technology," the Apple Watch's atrial fibrillation (AFib) history feature has been approved by the FDA to join the FDA's Medical Device Development Tools (MDDT) program. This means the wearable is now usable in clinical studies. The Verge reports: The FDA announcement describes using it as a noninvasive way to collect the data both before and after treatment: "Designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices to treat."
AI

Nurses Say Hospital Adoption of Half-Cooked 'AI' Is Reckless (techdirt.com) 106

An anonymous reader quotes a report from Techdirt: Last week, hundreds of nurses protested the implementation of sloppy AI into hospital systems in front of Kaiser Permanente. Their primary concern: that systems incapable of empathy are being integrated into an already dysfunctional sector without much thought toward patient care: "No computer, no AI can replace a human touch," said Amy Grewal, a registered nurse. "It cannot hold your loved one's hand. You cannot teach a computer how to have empathy."

There are certainly roles automation can play in easing strain on a sector full of burnout after COVID, particularly when it comes to administrative tasks. The concern, as with other industries dominated by executives with poor judgement, is that this is being used as a justification by for-profit hospital systems to cut corners further. From a National Nurses United blog post (spotted by 404 Media): "Nurses are not against scientific or technological advancement, but we will not accept algorithms replacing the expertise, experience, holistic, and hands-on approach we bring to patient care," they added.

Kaiser Permanente, for its part, insists it's simply leveraging "state-of-the-art tools and technologies that support our mission of providing high-quality, affordable health care to best meet our members' and patients' needs." The company claims its "Advance Alert" AI monitoring system -- which algorithmically analyzes patient data every hour -- has the potential to save upwards of 500 lives a year. The problem is that healthcare giants' primary obligation no longer appears to reside with patients, but with their financial results. And, that's even true in non-profit healthcare providers. That is seen in the form of cut corners, worse service, and an assault on already over-taxed labor via lower pay and higher workload (curiously, it never seems to impact outsized high-level executive compensation).

Medicine

PFAS Increase Likelihood of Death By Cardiovascular Disease, Study Shows (theguardian.com) 34

New submitter berghem shares a report from The Guardian: For the first time, researchers have formally shown that exposure to toxic PFAS increases the likelihood of death by cardiovascular disease, adding a new level of concern to the controversial chemicals' wide use. The findings are especially significant because proving an association with death by chemical exposure is difficult, but researchers were able to establish it by reviewing death records from northern Italy's Veneto region, where many residents for decades drank water highly contaminated with PFAS, also called "forever chemicals." Records further showed an increased likelihood of death from several cancers, but stopped short of establishing a formal association because of other factors. [...]

Veneto's drinking water was widely contaminated by a PFAS-production plant between 1985 and 2018. Researchers first found an excess of about 4,000 deaths during this period, or about one every three days. Part of the region was supplied with water from a different source, giving researchers the opportunity to compare records for tens of thousands of people who drank contaminated water and lived near those who did not. Though PFAS can affect the cardiovascular system in different ways, it is largely a problem because it produces stubbornly high and dangerous levels of cholesterol. The levels are difficult to control because they aren't caused by dietary or lifestyle choices that can be addressed with adjustments, but hormonal changes that affect the metabolism and the body's ability to control plaque in arteries. The study's authors suspect that post-traumatic stress disorder caused by the environmental disaster, which upended lives across the region, may also be contributing to circulatory disease. The evidence of a jump in kidney cancer was also "very clear," [said Annibale Biggeri, the peer-reviewed study's lead author, and a researcher with the University of Padua]. In the study's first five years, 16 cases were recorded, while 65 were recorded in the last five years. It also found elevated levels of testicular cancer during some time periods.

The records "showed clearly" that earlier life exposures led to higher levels of mortality, except for women who have multiple children. Previous research has found levels were higher in women with only one child. The chemicals accumulate in placentas and are passed on to children during pregnancy, which reduces levels in the body. Mortality levels among women who were of child-bearing age were generally lower, but increased in older women. The chemicals will be passed down to children for generations, said Laura Facciolo, a Veneto resident who drank contaminated water. She said the findings underscore the need to ban PFAS, and the disaster's injustice.
The findings have been published in the journal Environmental Health.
Medicine

Even Walmart Thinks American Healthcare Is Too Expensive (theverge.com) 237

Walmart isn't making enough money off its new health centers, so it decided to close up shop. From a report: The retail giant announced today that it'll shutter all 51 health centers it opened up across five states since 2019. Walmart is also getting rid of its virtual care program after acquiring telehealth provider MeMD in 2021. "We determined there is not a sustainable business model for us to continue," Walmart said in an announcement today.

"This is a difficult decision, and like others, the challenging reimbursement environment and escalating operating costs create a lack of profitability that make the care business unsustainable for us at this time," Walmart said today. It's an about-face from last year when Walmart said it planned to double its number of health clinics and expand into two new states in 2024.

Medicine

Marketing Cancer Drugs To Physicians Increases Prescribing Without Improving Mortality 33

Abstract of a paper on National Bureau of Economic Research: Physicians commonly receive marketing-related transfers from drug firms. We examine the impact of these relationships on the prescribing of physician-administered cancer drugs in Medicare. We find that prescribing of the associated drug increases 4\% in the twelve months after a payment is received, with the increase beginning sharply in the month of payment and fading out within a year. A marketing payment also leads physicians to begin treating cancer patients with lower expected mortality. While payments result in greater expenditure on cancer drugs, there are no associated improvements in patient mortality.
Privacy

96% of US Hospital Websites Share Visitor Info With Meta, Google, Data Brokers (theregister.com) 21

An anonymous reader quotes a report from The Guardian: Hospitals -- despite being places where people implicitly expect to have their personal details kept private -- frequently use tracking technologies on their websites to share user information with Google, Meta, data brokers, and other third parties, according to research published today. Academics at the University of Pennsylvania analyzed a nationally representative sample of 100 non-federal acute care hospitals -- essentially traditional hospitals with emergency departments -- and their findings were that 96 percent of their websites transmitted user data to third parties. Additionally, not all of these websites even had a privacy policy. And of the 71 percent that did, 56 percent disclosed specific third-party companies that could receive user information.

The researchers' latest work builds on a study they published a year ago of 3,747 US non-federal hospital websites. That found 98.6 percent tracked and transferred visitors' data to large tech and social media companies, advertising firms, and data brokers. To find the trackers on websites, the team checked out each hospitals' homepage on January 26 using webXray, an open source tool that detects third-party HTTP requests and matches them to the organizations receiving the data. They also recorded the number of third-party cookies per page. One name in particular stood out, in terms of who was receiving website visitors' information. "In every study we've done, in any part of the health system, Google, whose parent company is Alphabet, is on nearly every page, including hospitals," [Dr Ari Friedman, an assistant professor of emergency medicine at the University of Pennsylvania] observed. "From there, it declines," he continued. "Meta was on a little over half of hospital webpages, and the Meta Pixel is notable because it seems to be one of the grabbier entities out there in terms of tracking."

Both Meta and Google's tracking technologies have been the subject of criminal complaints and lawsuits over the years -- as have some healthcare companies that shared data with these and other advertisers. In addition, between 20 and 30 percent of the hospitals share data with Adobe, Friedman noted. "Everybody knows Adobe for PDFs. My understanding is they also have a tracking division within their ad division." Others include telecom and digital marketing companies like The Trade Desk and Verizon, plus tech giants Oracle, Microsoft, and Amazon, according to Friedman. Then there's also analytics firms including Hotjar and data brokers such as Acxiom. "And two thirds of hospital websites had some kind of data transfer to a third-party domain that we couldn't even identify," he added. Of the 71 hospital website privacy policies that the team found, 69 addressed the types of user information that was collected. The most common were IP addresses (80 percent), web browser name and version (75 percent), pages visited on the website (73 percent), and the website from which the user arrived (73 percent). Only 56 percent of these policies identified the third-party companies receiving user information.
In lieu of any federal data privacy law in the U.S., Friedman recommends users protect their personal information via the browser-based tools Ghostery and Privacy Badger, which identify and block transfers to third-party domains.
Biotech

Synchron Readies Large-Scale Brain Implant Trial (reuters.com) 22

A brain implant startup called Synchron is preparing to recruit patients for a large-scale clinical trial to seek commercial approval for its device. Reuters reports: Synchron on Monday plans to launch an online registry for patients interested in joining the trial meant to include dozens of participants, and has received interest from about 120 clinical trial centers to help run the study, CEO Thomas Oxley said in an interview. "Part of this registry is to start to enable local physicians to speak to patients with motor impairment," he said. "There's a lot of interest so we don't want it to come in a big bottleneck right before the study we'll be doing."

Synchron received U.S. authorization for preliminary testing in July 2021 and has implanted its device in six patients. Prior testing in four patients in Australia showed no serious adverse side effects, the company has reported. Synchron will be analyzing the U.S. data to prepare for the larger study, while awaiting authorization from the U.S. Food and Drug Administration to proceed, Oxley said. Synchron and the FDA declined to comment on the expected timing of that decision. The company aims to include patients who are paralyzed due to the neurodegenerative disease ALS (amyotrophic lateral sclerosis), stroke and multiple sclerosis, Oxley said. [...]

Synchron's device is delivered to the brain via the large vein that sits next to the motor cortex in the brain instead of being surgically implanted into the brain cortex like Neuralink's. The FDA has asked Synchron to screen stroke patients using a non-invasive test to determine whether they would respond to an implant, Oxley said. "They want to expand the market to people who have had a stroke severe enough to cause paralysis because if limited to quadriplegia, the market is way too small to be sustainable," Kip Ludwig, former program director for neural engineering at the U.S. National Institutes of Health, said of Synchron. In 2020, Synchron reported that patients, opens new tab in its Australian study could use its first-generation device to type an average of 16 characters per minute. That's better than non-invasive devices that sit atop the head and record the electrical activity of the brain, which have helped people type up to eight characters per minute, but not the leap forward that is hoped for with an implant, Ludwig said. Oxley would not say whether typing has gotten faster or offer any other details from the ongoing U.S. trial.
Reuters notes that Synchron's investors include billionaires Jeff Bezos and Bill Gates. It's competing with Elon Musk's Neuralink brain implant startup and claims it's farther along in the process of testing its device.

Earlier this year, Neuralink said it implanted a chip in its first human patient. It later said the patient fully recovered and was able to control a computer mouse using their thoughts.
Space

VCs Invest $90M in Varda Space Industries' Microgravity Drug Manufacturing (techcrunch.com) 20

"Varda Space Industries has closed a massive tranche of funding," reports TechCrunch, "just weeks after its first drug manufacturing capsule returned from orbit."

Varda has now raised $145 million to date, the article points out, and the $90 million in new Series B funding "marks an inflection point for the company, which is now gearing up to scale from the initial demonstration mission to a regular set of missions carrying customer payloads, Varda founder Delian Asparouhov told TechCrunch." El Segundo-based Varda was founded in 2021 by Asparouhov, who is also a partner at Founders Fund, and Will Bruey, a spacecraft engineer who cut his teeth at SpaceX. The pair had an audacious goal to commercialize what until very recently was promising but ultimately small-scale research into the effects of microgravity on pharmaceutical crystals... Astronauts have been conducting protein crystallization experiments in space for decades on the International Space Station and before that, the Space Shuttle. But the business case for expanding this research has never materialized — until now...

Part of the reason Varda is possible today is due to the availability of regular, low-cost rideshare launches from SpaceX and Rocket Lab's innovations in satellite bus manufacturing. Even beyond these external partnerships, the startup has made significant headway in its own right, as the success of the first mission showed: Their reentry capsule appears to have performed flawlessly and the experiment to reformulate the HIV medicine ritonavir was executed without a hitch, it says. Varda has also started publishing the results of its internal R&D efforts, including a scientific paper on its hyper-gravity (as opposed to microgravity) crystallization platform, which the startup developed as a sort of screening method prior to sending drugs to space. [The paper is titled "Gravity as a Knob for Tuning Particle Size Distributions of Small Molecules."] It's an entirely new field of research that takes advantage of the ability to truly unlock gravity as a variable in scientific experiments. "Over time, we will be able to generate data sets between both hyper-gravity and microgravity and start to show correlations," he said....

In a recent podcast appearance, he specified that the all-in initial mission cost around $12 million, which will drop to $5-6 million by mission 4 and $2.5 million or less by mission 10.) Larger capsules are also in the longer-term pipeline, though also not until the 2027 time frame. Asparouhov also confirmed that pharmaceuticals will be Varda's sole focus for the next 10-20 (or more) years, based on the company's conviction that pharmaceutical products will generate more economic value compared to other materials. A lot of that comes down to the fact that there are a significant set of drugs that require only a "seed" of the material that can only be made in microgravity, and the rest of the drug formulation can be completed here on Earth...

The company is also aiming to improve the processing capabilities of the on-board pharmaceutical reactor. The first mission carried just one drug protein, but in the future the company hopes to process multiple drug products that could be run through different processing regimes. In the future, other missions could carry larger reactors for drugs that do need more than the "seed" crystal, and those mission profiles would be closer to something like mass manufacturing.

Varda already has "a handful" of signed contracts with biotech companies, according to the article — and Varda's next manufacturing mission "will launch later this year."
Medicine

Are Your Solar Eclipse Glasses Fake? (scientificamerican.com) 90

SonicSpike shares a report from Scientific American: A day after the American Astronomical Society (AAS) announced that there were no signs of unsafe eclipse glasses or other solar viewers on the market in early March, astronomer and science communicator Rick Fienberg received an alarming call. Fienberg is project manager of the AAS Solar Eclipse Task Force, which is busy preparing for the total eclipse over North America on April 8. He's the creator of a list of vetted solar filters and viewers that will protect wearers' eyes as they watch the moon move in front of the sun. When a solar eclipse last crossed a major swath of the U.S. in 2017, Fienberg and his team spotted some counterfeit glasses entering the marketplace -- imitations that distributors claimed were manufactured by vetted companies. Testing at accredited labs indicated that many counterfeits were actually safe to use, however. This led the task force to describe such eclipse glasses as "misleading" but not "dangerous" in a March 11 statement meant to reassure the public.

But then Fienberg's phone rang. The caller was "a guy who had bought thousands of eclipse glasses from a distributor who had been on our list at one point," Fienberg says. "Those glasses were not safe. They were no darker than ordinary sunglasses." Legitimate eclipse glasses are at least 1,000 times darker than the darkest sunglasses you can buy. Fienberg contacted Cangnan County Qiwei Craft, a Chinese factory that he knew manufactured safe glasses and had -- in the past -- sold them to the distributor in question. But this time, Fienberg says, factory representatives told him they hadn't sold to that distributor in a long while. "That's when we switched from being concerned about only counterfeits to being concerned about actual fakes," Fienberg says. The AAS does not have a confident estimate of how many fake or counterfeit glasses are for sale out there. And though Fienberg doesn't think this is a widespread problem, the situation is an "iceberg kind of concern," he says, because there are likely more examples than the ones he knows about. While counterfeit glasses may still be safe to use, completely fake glasses could put wearers in serious danger. [...]

While lab tests are the best way to determine whether glasses meet the ISO standard, Fienberg says there is a three-part test people can do at home if they're concerned their eclipse viewers aren't up to the task. First, put your glasses on indoors and look around. The only things you should be able to see are very bright lights, such as a halogen bulb or a smartphone flashlight. Then, if the glasses pass the indoor test, bring them outside -- but don't look at the sun just yet. Look around: it should be too dark to see distant hills, trees or even the ground. If that second test is passed, keep the glasses on and quickly glance at the sun. You should comfortably see a bright, sharp-edged round disk. If your glasses pass all three tests, they are probably safe to wear. Still, Fienberg points out that it's best to use them for only a few seconds every minute or so during the eclipse; this cautious approach is how they're intended to be used. And if you don't trust your glasses for April's celestial event, you could try to find a reliable pair in the next two decades. "You only have to wait 20 years for another really good eclipse year in the [United] States," Fienberg says.

Medicine

America's FDA Forced to Settle 'Groundless' Lawsuit Over Its Ivermectin Warnings (msn.com) 350

As a department of America's federal Health agency, the Food and Drug Administration is responsible for public health rules, including prescription medicines. And the FDA "has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19," they confirmed to CNN this week. "The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19."

But there was also a lawsuit. In "one of its more popular pandemic-era social media campaigns," the agency tweeted out "You are not a horse. You are not a cow. Seriously, y'all. Stop it." The post attracted nearly 106,000 likes — and over 46,000 reposts, and was followed by another post on Instagram. "Stop it with the #ivermectin. It's not authorized for treating #COVID."

Los Angeles Times business columnist Michael Hiltzik writes that the posts triggered a "groundless" lawsuit: It was those latter two lines that exercised three physicians who had been prescribing ivermectin for patients. They sued the FDA in 2022, asserting that its advisory illegally interfered with the practice of medicine — specifically with their ability to continue prescribing the drug. A federal judge in Texas threw out their case, but the 5th Circuit Court of Appeals — the source of a series of chuckleheaded antigovernment rulings in recent years — reinstated it last year, returning it to the original judge for reconsideration.

Now the FDA has settled the case by agreeing to delete the horse post and two similar posts from its accounts on the social media platforms X, LinkedIn and Facebook. The agency also agreed to retire a consumer advisory titled "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19." In defending its decision, the FDA said it "has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old."

That sounds reasonable enough, but it's a major blunder. It leaves on the books the 5th Circuit's adverse ruling, in which a panel of three judges found that the FDA's advisory crossed the line from informing consumers, which they said is all right, to recommending that consumers take some action, which they said is not all right... That's a misinterpretation of the law and the FDA's actions, according to Dorit Rubinstein Reiss of UC College of the Law in San Francisco. "The FDA will seek to make recommendations against the misuse of products in the future, and having that decision on the books will be used to litigate against it," she observed after the settlement.

"A survey by Boston University and the University of Michigan estimated that Medicare and private insurers had wasted $130 million on ivermectin prescriptions for COVID in 2021 alone."
Science

Memories Are Made By Breaking DNA - and Fixing It (nature.com) 23

When a long-term memory forms, some brain cells experience a rush of electrical activity so strong that it snaps their DNA. Then, an inflammatory response kicks in, repairing this damage and helping to cement the memory, a study in mice shows. Nature: The findings, published on 27 March in Nature, are "extremely exciting," says Li-Huei Tsai, a neurobiologist at the Massachusetts Institute of Technology in Cambridge who was not involved in the work. They contribute to the picture that forming memories is a "risky business," she says. Normally, breaks in both strands of the double helix DNA molecule are associated with diseases including cancer. But in this case, the DNA damage-and-repair cycle offers one explanation for how memories might form and last.

It also suggests a tantalizing possibility: this cycle might be faulty in people with neurodegenerative diseases such as Alzheimer's, causing a build-up of errors in a neuron's DNA, says study co-author Jelena Radulovic, a neuroscientist at the Albert Einstein College of Medicine in New York City. [...] To better understand the part these DNA breaks play in memory formation, Radulovic and her colleagues trained mice to associate a small electrical shock with a new environment, so that when the animals were once again put into that environment, they would 'remember' the experience and show signs of fear, such as freezing in place. Then the researchers examined gene activity in neurons in a brain area key to memory -- the hippocampus. They found that some genes responsible for inflammation were active in a set of neurons four days after training. Three weeks after training, the same genes were much less active.

Science

Pregnancy May Increase Biological Age 2 Years - But Some End Up 'Younger' (science.org) 29

Slashdot reader sciencehabit shared this report from Science magazine: Nurturing a growing fetus requires a series of profound physical, hormonal, and chemical changes that may rewire every major organ in the body and can cause serious health complications such as hypertension and preeclampsia. But does being pregnant actually take years off your life...?

Today in Cell Metabolism, scientists report that the stress of pregnancy can cause a person's biological age to increase by up to 2 years — a trend that may reverse itself in the months that follow. In some cases, the authors write, those who breastfeed their children after giving birth may end up biologically "younger" than during early pregnancy. The finding represents yet another piece of "compelling" evidence that events during and after pregnancy can have far-reaching health consequences, says Elizabeth Bertone-Johnson, an epidemiologist at the University of Massachusetts Amherst who wasn't involved in the new study...

The discovery that biological aging isn't necessarily a linear process "came as a real surprise," says Kieran O'Donnell, a perinatal researcher at the Yale School of Medicine... But blood samples from 68 participants, collected 3 months after giving birth, revealed a dramatic about-face. Although being pregnant had initially aged their cells between 1 and 2 years, says O'Donnell, their biological age now appeared to be 3 to 8 years younger than it had been during early pregnancy — with different epigenetic clocks algorithms providing slightly bigger or smaller estimates.

AI

AI Surpasses Doctors In Spotting Early Breast Cancer Signs In NHS Trial 57

An AI tool named Mia, tested by the NHS, successfully detected signs of breast cancer in 11 women which had been missed by human doctors. The BBC reports: The tool, called Mia, was piloted alongside NHS clinicians and analyzed the mammograms of over 10,000 women. Most of them were cancer-free, but it successfully flagged all of those with symptoms, as well as an extra 11 the doctors did not identify. At their earliest stages, cancers can be extremely small and hard to spot. The BBC saw Mia in action at NHS Grampian, where we were shown tumors that were practically invisible to the human eye. But, depending on their type, they can grow and spread rapidly.

Barbara was one of the 11 patients whose cancer was flagged by Mia but had not been spotted on her scan when it was studied by the hospital radiologists. Because her 6mm tumor was caught so early she had an operation but only needed five days of radiotherapy. Breast cancer patients with tumors which are smaller than 15mm when discovered have a 90% survival rate over the following five years. Barbara said she was pleased the treatment was much less invasive than that of her sister and mother, who had previously also battled the disease. Without the AI tool's assistance, Barbara's cancer would potentially not have been spotted until her next routine mammogram three years later. She had not experienced any noticeable symptoms.
"These results are encouraging and help to highlight the exciting potential AI presents for diagnostics. There is no question that real-life clinical radiologists are essential and irreplaceable, but a clinical radiologist using insights from validated AI tools will increasingly be a formidable force in patient care." said Dr Katharine Halliday, President of the Royal College of Radiologists.
Medicine

More Than Half of Chickenpox Diagnoses Are Wrong, Study Finds (arstechnica.com) 52

An anonymous reader shares a report: Thanks to the vaccination program that began in 1995, chickenpox is now relatively rare. Cases of the miserable, itchy condition have fallen more than 97 percent. But, while children have largely put the oatmeal baths and oven mitts behind them, doctors have apparently let their diagnostic skills get a little crusty. According to a study published Thursday, public health researchers in Minnesota found that 55 percent of people diagnosed with chickenpox based on their symptoms were actually negative for the varicella-zoster virus, the virus that causes chickenpox. The study noted that the people were all diagnosed in person by health care providers in medical facilities. But, instead of chickenpox, lab testing showed that some of the patients were actually infected with an enterovirus, which can cause a rash, or the herpes simplex virus 1, which causes cold sores.

The study, published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, supports expanding laboratory testing for suspected chickenpox cases in the state's program and highlights that diagnoses based on symptoms are "unreliable." For one thing, doctors simply see far fewer chickenpox cases these days because of the protection from vaccines. While chickenpox cases in the US previously reached 4 million each year, with 10,500 to 13,500 hospitalizations and 100 to 150 deaths, there are now fewer than 150,000 cases,1,400 hospitalizations, and 30 deaths each year, the CDC reports. Vaccination is more than 90 percent effective at preventing the disease. In the rare cases where a vaccinated person contracts chickenpox, the muted rashes are challenging to identify by eye. But even in unvaccinated children, chickenpox can be tricky to pick out; it can easily be confused with measles, insect bites, enterovirus, skin infections such as scabies and impetigo, herpes viruses, and hand, foot, and mouth disease.

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