Medicine

FDA Bans BVO, an Additive Found In Some Fruity Sodas (axios.com) 176

An anonymous reader quotes a report from Axios: The Food and Drug Administration will no longer allow the use of brominated vegetable oil (BVO) in food products and sodas due to concerns it poses a threat to people's health, the FDA announced Tuesday. The ban follows similar action in California against the food additive that's modified with bromine, which has been used in small quantities as a stabilizer in some citrus-flavored drinks and which is also found in fire retardants.

Jim Jones, the deputy commissioner for the FDA's Human Foods Program, said in a statement that "removal of the only authorized use of BVO from the food supply was based on a thorough review of current science and research findings that raised safety concerns." The FDA "concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans," per an agency statement. A 2022 FDA study found that oral exposure to the additive "is associated with increased tissue levels of bromine and that at high levels of exposure the thyroid is a target organ of potential negative health effects in rodents."
The ban takes effect on August 2. Companies will have one year from then to "reformulate, relabel, and deplete the inventory of BVO-containing products before the FDA begins enforcing the final rule," according to the agency.
United States

Biden Administration Provides $504 Million To Support 12 Tech Hubs Nationwide (apnews.com) 119

The Biden administration said Tuesday that it was providing $504 million in implementation grants for a dozen technology hubs in Ohio, Montana, Nevada and Florida, among other locations. From a report: The money would support the development of quantum computing, biomanufacturing, lithium batteries, computer chips, personal medicine and other technologies. The Democratic administration is trying to encourage more technological innovation across the country, instead of allowing it be concentrated in a few metro areas such as San Francisco, Seattle, Boston and New York City.

"The reality is there are smart people, great entrepreneurs, and leading-edge research institutions all across the country," Commerce Secretary Gina Raimondo said in a call previewing the announcement. "We're leaving so much potential on the table if we don't give them the resources to compete and win in the tech sectors that will define the 21st century global economy."

Science

People Can Move This Bionic Leg Just By Thinking About It (technologyreview.com) 13

An anonymous reader shares a report: When someone loses part of a leg, a prosthetic can make it easier to get around. But most prosthetics are static, cumbersome, and hard to move. A new neural interface connects a bionic limb to nerve endings in the thigh, allowing the limb to be controlled by the brain. The new device, which is described today in Nature Medicine, could help people with lower-leg amputations feel as if their prosthesis is part of them. "When you ask a patient 'What is your body?' They don't include the prosthesis," says MIT biophysicist Hugh Herr, one of the lead authors on the study. The work is personal for him: he lost both his lower legs in a climbing accident when he was 17. He says linking the brain to the prosthesis can make it feel more like part of someone's anatomy, which can have a positive emotional impact.

Getting the neural interface hooked up to a prosthetic takes two steps. First, patients undergo surgery. Following a lower leg amputation, portions of shin and calf muscle still remain. The operation connects shin muscle, which contracts to make the ankle flex upward, to calf muscle, which counteracts this movement. The prosthetic can also be fitted at this point. Reattaching the remnants of these muscles can enable the prosthetic to move more dynamically. It can also reduce phantom limb pain, and patients are less likely to trip and fall. "The surgery stands on its own," says Amy Pietrafitta, a para-athlete who received it in 2018. "I feel like I have my leg back." But natural movements are still limited when the prosthetic isn't connected to the nervous system.

In step two, surface electrodes measure nerve activity from the brain to the calf and shin muscles, indicating an intention to move the lower leg. A small computer in the bionic leg decodes those nerve signals and moves the leg accordingly, allowing the patient to move the limb more naturally. "If you have intact biological limbs, you can walk up and down steps, for example, and not even think about it. It's involuntary," says Herr. "That's the case with our patients, but their limb is made of titanium and silicone." The authors compared the mobility of seven patients using a neural interface with that of patients who had not received the surgery. Patients using the neural interface could walk 41% faster and climb sloped surfaces and steps. They could also dodge obstacles more nimbly and had better balance. And they described feeling that the prosthetic was truly a part of their body rather than just a tool that they used to get around.

Medicine

Multivitamin Supplements Don't Help You Live Longer, Major Study Shows (go.com) 129

A study from the National Institutes of Health (NIH) analyzed data from nearly 400,000 healthy adults over 20 years and determined that "multivitamin use to improve longevity is not supported." The findings were published in JAMA Network Open. ABC News reports: The study found no evidence that daily multivitamin consumption reduced the risk of death from conditions such as heart disease or cancer. Rather than living longer, otherwise healthy people who took daily multivitamins were slightly more likely (4%) than non-users to die in the study period, according to researchers. Researchers reported nearly 165,000 deaths occurring during the follow-up period of the study, out of the initial group of 390,000 participants. The study, however, did not analyze data from people with pre-existing vitamin deficiencies. "What this study shows is that, generally, multivitamins aren't going to help you live longer," Dr. Jade A Cobern, MD, MPH, board-certified physician in pediatrics and general preventive medicine, told ABC News. "Even though the cost of many multivitamins isn't high, this is still an expense that many people can be spared from."
Medicine

Ultra-Processed Foods Need Tobacco-Style Warnings, Says Scientist (theguardian.com) 149

An anonymous reader quotes a report from The Guardian: Ultra-processed foods (UPFs) are displacing healthy diets "all over the world" despite growing evidence of the risks they pose and should be sold with tobacco-style warnings, according to the nutritional scientist who first coined the term. Prof Carlos Monteiro of the University of Sao Paulo will highlight the increasing danger UPFs present to children and adults at the International Congress on Obesity this week. "UPFs are increasing their share in and domination of global diets, despite the risk they represent to health in terms of increasing the risk of multiple chronic diseases," Monteiro told the Guardian ahead of the conference in Sao Paulo. "UPFs are displacing healthier, less processed foods all over the world, and also causing a deterioration in diet quality due to their several harmful attributes. Together, these foods are driving the pandemic of obesity and other diet-related chronic diseases, such as diabetes."

Monteiro and his colleagues first used the phrase UPF 15 years ago when designing the food classification system "Nova." This assesses not only nutritional content but also the processes food undergoes before it is consumed. The system places food and drink into four groups: minimally processed food, processed culinary ingredients, processed food and ultra-processed food. Monteiro told the Guardian he was now so concerned about the impact UPF was having on human health that studies and reviews were no longer sufficient to warn the public of the health hazards. "Public health campaigns are needed like those against tobacco to curb the dangers of UPFs," he told the Guardian in an email. "Such campaigns would include the health dangers of consumption of UPFs. Advertisements for UPFs should also be banned or heavily restricted, and front-of-pack warnings should be introduced similar to those used for cigarette packs."

He will tell delegates: "Sales of UPFs in schools and health facilities should be banned, and there should be heavy taxation of UPFs, with the revenue generated used to subsidize fresh foods." Monteiro will tell the conference that food giants marketing UPFs know that, in order to be competitive, their products must be more convenient, more affordable and tastier than freshly prepared meals. "To maximize profits, these UPFs must have lower cost of production and be overconsumed," he said. He will also draw parallels between UPF and tobacco companies. "Both tobacco and UPFs cause numerous serious illnesses and premature mortality; both are produced by transnational corporations that invest the enormous profits they obtain with their attractive/addictive products in aggressive marketing strategies, and in lobbying against regulation; and both are pathogenic (dangerous) by design, so reformulation is not a solution."

Medicine

Gilead's Twice-Yearly Shot to Prevent HIV Succeeds in Late-Stage Trial (cnbc.com) 66

An anonymous reader shared this report from CNBC: Gilead's experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial, the company said Thursday. None of the roughly 2,000 women in the trial who received the lenacapavir shot had contracted HIV by an interim analysis, prompting the independent data monitoring committee to recommend Gilead unblind the Phase 3 trial and offer the treatment to everyone in the study. Other participants had received standard daily pills.
The company expects to share more data by early next year, the article adds, and if its results are positive, the company could bring its drug to the market as soon as late 2025. (By Fridayt the company's stock price had risen nearly 12%.)

There's already other HIV-preventing options, the article points out, but they're taken by "only a little more than one-third of people in the U.S. who could benefit...according to data from the Centers for Disease Control and Prevention." Part of the problem?

"Daily pills dominate the market, but drugmakers are now focusing on developing longer-acting shots... Health policymakers and advocates hope longer-acting options could reach people who can't or don't want to take a daily pill and better prevent the spread of a virus that caused about 1 million new infections globally in 2022."
Privacy

Change Healthcare Confirms Ransomware Hackers Stole Medical Records on a 'Substantial Proportion' of Americans (techcrunch.com) 10

Change Healthcare has confirmed a February ransomware attack on its systems, which brought widespread disruption to the U.S. healthcare system for weeks and resulted in the theft of medical records affecting a "substantial proportion of people in America." TechCrunch: In a statement Thursday, Change Healthcare said it has begun the process of notifying affected individuals whose information was stolen during the cyberattack. The health tech giant, owned by U.S. insurance conglomerate UnitedHealth Group, processes patient insurance and billing for thousands of hospitals, pharmacies and medical practices across the U.S. healthcare sector. As such, the company has access to massive amounts of health information on about a third of all Americans.
Medicine

Researchers Still Fighting For MDMA Therapy After FDA Advisors Vote Against It (bbc.com) 56

An anonymous reader quotes a report from the BBC: A vote against using MDMA as part of therapy for PTSD has provoked a powerful backlash among researchers who study psychedelic drugs. Some 13 million Americans struggle with post-traumatic stress disorder (PTSD). Existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. So, there was distinct disappointment when an advisory committee at the US Food and Drug Administration (FDA) voted earlier this month against a therapy that many had hoped could offer the first new treatment for PTSD in 25 years. A number of experts who study psychedelics have since spoken out in support of MDMA-assisted therapy for PTSD and have sharply criticized the recommendations of the FDA's Psychopharmacological Drugs Advisory Committee. But some are still optimistic that the treatment might be approved when the FDA delivers its final decision in August.

While MDMA, also commonly known as ecstasy or molly, is listed as a Schedule 1 controlled substance in the US and so is illegal to use outside research, there has been a growing number of studies suggesting that when used with psychotherapy it could have potential for treating PTSD and some other mental health conditions. Ahead of the meeting, FDA approval of MDMA-assisted therapy for PTSD seemed likely, says Sandeep Nayak, an assistant professor of psychiatry at Johns Hopkins University, who investigates psychedelics as treatments for substance use and mood disorders. About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase 3 clinical trials. It's an outcome that is "almost double that of existing medications", says Gul Dolen, a neuroscientist at the University of California, Berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "What's more, [the treatment] led to durable improvements in these patients lasting at least six months."

About half of people who enroll in current gold standard PTSD treatments drop out, which is "absurd," says Loree Sutton, a psychiatrist and retired Brigadier General in the US Army. She says new treatments are essential. "We have to do better." "Even if there are risks, we've got to figure this out, because we cannot not let this treatment be available," adds Rachel Yehuda, a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai who has conducted studies on the effects of MDMA-assisted therapy for PTSD. "Without it, we're just leaving too many people in suffering that they don't need to be in, and that is not right." The FDA is currently considering an application from California-based drug company Lykos Therapeutics for using MDMA capsules taken in conjunction with therapy in the treatment of PTSD. In the recent FDA advisory meeting, committee members cited apparent flaws in study design and data collection. The nine-hour hearing concluded with committee members voting 9-2 that the available data do not show "that the drug is effective" for PTSD, and voting 10-1 that the benefits of MDMA do not outweigh the risks.

Science

Microplastics Discovered In Human Penises For the First Time (cnn.com) 81

An anonymous reader writes: Scientists have found microplastics in human penises for the first time, as concerns over the tiny particles' proliferation and potential health effects mount. Seven different kinds of microplastics were found in four out of five samples of penis tissue taken from five different men as part of a study published in IJIR: Your Sexual Medicine Journal on Wednesday. Microplastics are polymer fragments that can range from less than 0.2 inch (5 millimeters) down to 1/25,000th of an inch (1 micrometer). Anything smaller is a nanoplastic that must be measured in billionths of a meter. They form when larger plastics break down, either by chemically degrading or physically wearing down into smaller pieces.

Some minuscule particles can invade individual cells and tissues in major organs, experts say, and evidence is mounting that they are increasingly present in our bodies. Study lead author Ranjith Ramasamy, an expert in reproductive urology who conducted the research while working at the University of Miami, told CNN that he used a previous study that found evidence of microplastics in the human heart as a basis for his research. Ramasamy said he wasn't surprised to find microplastics in the penis, as it is a "very vascular organ," like the heart.

United States

America's Defense Department Ran a Secret Disinfo Campaign Online Against China's Covid Vaccine (reuters.com) 280

"At the height of the COVID-19 pandemic, the U.S. military launched a secret campaign to counter what it perceived as China's growing influence in the Philippines..." reports Reuters.

"It aimed to sow doubt about the safety and efficacy of vaccines and other life-saving aid that was being supplied by China, a Reuters investigation found."

Reuters interviewed "more than two dozen current and former U.S officials, military contractors, social media analysts and academic researchers," and also reviewed posts on social media, technical data and documents about "a set of fake social media accounts used by the U.S. military" — some active for more than five years. Friday they reported the results of their investigation: Through phony internet accounts meant to impersonate Filipinos, the military's propaganda efforts morphed into an anti-vax campaign. Social media posts decried the quality of face masks, test kits and the first vaccine that would become available in the Philippines — China's Sinovac inoculation. Reuters identified at least 300 accounts on X, formerly Twitter, that matched descriptions shared by former U.S. military officials familiar with the Philippines operation. Almost all were created in the summer of 2020 and centered on the slogan #Chinaangvirus — Tagalog for China is the virus.

"COVID came from China and the VACCINE also came from China, don't trust China!" one typical tweet from July 2020 read in Tagalog. The words were next to a photo of a syringe beside a Chinese flag and a soaring chart of infections. Another post read: "From China — PPE, Face Mask, Vaccine: FAKE. But the Coronavirus is real." After Reuters asked X about the accounts, the social media company removed the profiles, determining they were part of a coordinated bot campaign based on activity patterns and internal data.

The U.S. military's anti-vax effort began in the spring of 2020 and expanded beyond Southeast Asia before it was terminated in mid-2021, Reuters determined. Tailoring the propaganda campaign to local audiences across Central Asia and the Middle East, the Pentagon used a combination of fake social media accounts on multiple platforms to spread fear of China's vaccines among Muslims at a time when the virus was killing tens of thousands of people each day. A key part of the strategy: amplify the disputed contention that, because vaccines sometimes contain pork gelatin, China's shots could be considered forbidden under Islamic law...

A senior Defense Department official acknowledged the U.S. military engaged in secret propaganda to disparage China's vaccine in the developing world, but the official declined to provide details. A Pentagon spokeswoman... also noted that China had started a "disinformation campaign to falsely blame the United States for the spread of COVID-19."

A senior U.S. military officer directly involved in the campaign told Reuters that "We didn't do a good job sharing vaccines with partners. So what was left to us was to throw shade on China's."

At least six senior State Department officials for the region objected, according to the article. But in 2019 U.S. Defense Secretary Mark Esper signed "a secret order" that "elevated the Pentagon's competition with China and Russia to the priority of active combat, enabling commanders to sidestep the StateDepartment when conducting psyops against those adversaries."

[A senior defense official] said the Pentagon has rescinded parts of Esper's 2019 order that allowed military commanders to bypass the approval of U.S. ambassadors when waging psychological operations. The rules now mandate that military commanders work closely with U.S. diplomats in the country where they seek to have an impact. The policy also restricts psychological operations aimed at "broad population messaging," such as those used to promote vaccine hesitancy during COVID...

Nevertheless, the Pentagon's clandestine propaganda efforts are set to continue. In an unclassified strategy document last year, top Pentagon generals wrote that the U.S. military could undermine adversaries such as China and Russia using "disinformation spread across social media, false narratives disguised as news, and similar subversive activities [to] weaken societal trust by undermining the foundations of government."

And in February, the contractor that worked on the anti-vax campaign — General Dynamics IT — won a $493 million contract. Its mission: to continue providing clandestine influence services for the military.

Japan

Flesh-Eating Bacteria That Can Kill in Two Days Spreads in Japan (msn.com) 43

Bloomberg reports: A disease caused by a rare "flesh-eating bacteria" that can kill people within 48 hours is spreading in Japan after the country relaxed Covid-era restrictions. Cases of streptococcal toxic shock syndrome (STSS) reached 977 this year by June 2, higher than the record 941 cases reported for all of last year, according to the National Institute of Infectious Diseases, which has been tracking incidences of the disease since 1999.

Group A Streptococcus (GAS) typically causes swelling and sore throat in children known as "strep throat," but some types of the bacteria can lead to symptoms developing rapidly, including limb pain and swelling, fever, low blood pressure, that can be followed by necrosis, breathing problems, organ failure and death. People over 50 are more prone to the disease. "Most of the deaths happen within 48 hours," said Ken Kikuchi, a professor in infectious diseases at Tokyo Women's Medical University. "As soon as a patient notices swelling in foot in the morning, it can expand to the knee by noon, and they can die within 48 hours...."

At the current rate of infections, the number of cases in Japan could reach 2,500 this year, with a "terrifying" mortality rate of 30%, Kikuchi said.

Medicine

Security Lessons from the Change Healthcare Ransomware Catastrophe (csoonline.com) 45

The $22 million paid by Change Healthcare's parent company to unlock its systems "may have emboldened bad actors to further target the vulnerable industry," writes Axios: There were 44 attacks against the health care sector in April, the most that [cybersecurity firm] Recorded Future has seen in the four years it's been collecting data. It was also the second-largest month-over-month jump, after 30 ransomware attacks were recorded in March. There were 32 attacks in February and May.
But an analysis by the security-focused magazine CSO says the "disastrous" incident also "starkly illustrated the fragility of the healthcare sector, prompting calls for regulatory action." In response to the attack, US politicians have called for mandated baseline cybersecurity standards in the health sector, as well as better information sharing. They have also raised concerns that industry consolidation is increasing cyber risk.
So what went wrong? The attackers used a set of stolen credentials to remotely access the company's systems. But the article also notes Change Healthcare's systems "suffered from a lack of segmentation, which enables easy lateral movement of the attack" — and that the company's acquisition may have played a role: Mergers and acquisitions create new cyber threats because they involve the integration of systems, data, and processes from different organizations, each with its own security protocols and potential vulnerabilities. "During this transition, cybercriminals can exploit discrepancies in security measures, gaps in IT governance, and the increased complexity of managing merged IT environments," Aron Brand, CTO of CTERA told CSOonline. "Additionally, the heightened sharing of sensitive information between parties provides more opportunities for data breaches."
And "In the end, paying the ransom failed to protect UHG from secondary attempts at extortion." In April, cybercriminals from the RansomHub group threatened to leak portions of 6TB of sensitive data stolen from the breach of Change Healthcare, and obtained through Nichy, according to an analysis by security vendor Forescout. An estimated one in three Americans had their sensitive data exposed as a result of the attack. Such secondary scams are becoming increasingly commonplace and healthcare providers are particularly at risk, according to compliance experts... The US Department of Health and Human Services (HHS) is investigating whether a breach of protected health information occurred in assessing whether either UHG or Change Healthcare violated strict healthcare sector privacy regulations.
Thanks to Slashdot reader snydeq for sharing the article.
Medicine

Advisory Panel of Experts Endorses FDA Approval of New Alzheimer's Drug (nytimes.com) 20

An anonymous reader quotes a report from the New York Times: A committee of independent advisers to the Food and Drug Administration voted unanimously on Monday that the benefits outweigh the risks of the newest experimental drug for Alzheimer's disease. Alzheimer's afflicts more than six million Americans. It has no cure, and there is no treatment or lifestyle modification that can restore memory loss or reverse cognitive decline. The drug, made by Eli Lilly, is donanemab. It modestly slowed cognitive decline in patients in the early stages of the disease but also had significant safety risks, including swelling and bleeding in the brain. The committee concluded, though, that the consequences of Alzheimer's are so dire that even a modest benefit can be worthwhile.

The F.D.A. usually follows the advice of the agency's advisory committees but not always. The drug is based on a long-held hypothesis that Alzheimer's disease begins when rough hard balls of amyloid, a protein, pile up in patients' brains, followed by a cascade of reactions leading to the death of neurons. The idea is to treat Alzheimer's by attacking amyloid, clearing it from the brain. Two similar amyloid-fighting drugs were approved recently: Leqembi, made by Eisai and Biogen, was approved last year. That drug's risks and modest benefits are similar to those of donanemab. Aduhelm, made by Biogen, is the other drug and was approved in 2021 but was discontinued because there was insufficient evidence that it could benefit patients. Donanemab was expected to be approved earlier this year, but in March, the F.D.A. decided that, instead, it would require donanemabto undergo the scrutiny of an independent advisory committee, a surprise to Eli Lilly.

The vote, said Dr. Daniel Skovronsky, chief scientific officer at Lilly, confirmed his 25-year quest to find a way to intervene in the Alzheimer's disease. Now, he said, the company is starting a study that, it hopes, will stop the disease before symptoms even begin. At issue before the committee on Monday were some unusual aspects of donanemab's clinical trials, especially that study participants stopped taking the drug as soon as their amyloid was cleared. Some experts questioned whether stopping was the best strategy and whether clinical practice should include halting the treatment after amyloid clearance.

Medicine

Researchers Plan To Retract Landmark Alzheimer's Paper Containing Doctored Images (science.org) 69

An anonymous reader quotes a report from Science Magazine: Authors of a landmark Alzheimer's disease research paper published in Nature in 2006 have agreed to retract the study in response to allegations of image manipulation. University of Minnesota (UMN) Twin Cities neuroscientist Karen Ashe, the paper's senior author, acknowledged in a post on the journal discussion site PubPeer that the paper contains doctored images. The study has been cited nearly 2500 times, and would be the most cited paper ever to be retracted, according to Retraction Watch data. "Although I had no knowledge of any image manipulations in the published paper until it was brought to my attention two years ago," Ashe wrote on PubPeer, "it is clear that several of the figures in Lesne et al. (2006) have been manipulated ... for which I as the senior and corresponding author take ultimate responsibility." After initially arguing the paper's problems could be addressed with a correction, Ashe said in another post last week that all of the authors had agreed to a retraction -- with the exception of its first author, UMN neuro-scientist Sylvain Lesne, a protege of Ashe's who was the focus of a 2022 investigation by Science. "It's unfortunate that it has taken 2 years to make the decision to retract," says Donna Wilcock, an Indiana University neuroscientist and editor of the journal Alzheimer's & Dementia. "The evidence of manipulation was overwhelming."

The 2006 paper suggested an amyloid beta (AB) protein called AB*56 could cause Alzheimer's. AB proteins have long been linked to the disease. The authors reported that AB*56 was present in mice genetically engineered to develop an Alzheimer's-like condition, and that it built up in step with their cognitive decline. The team also reported memory deficits in rats injected with AB*56. For years researchers had tried to improve Alzheimer's outcomes by stripping amyloid proteins from the brain, but the experimental drugs all failed. AB*56 seemed to offer a more specific and promising therapeutic target, and many embraced the finding. Funding for related work rose sharply. But the Science investigation revealed evidence that the Nature paper and numerous others co-authored by Lesne, some listing Ashe as senior author, appeared to use manipulated data. After the story was published, leading scientists who had cited the paper to support their own experiments questioned whether AB*56 could be reliably detected and purified as described by Lesne and Ashe -- or even existed. Some said the problems in that paper and others supported fresh doubts about the dominant hypothesis that amyloid drives Alzheimer's. Others maintained that the hypothesis remains viable. That debate has continued amid the approval of the antiamyloid drug Leqembi, which modestly slows cognitive decline but carries risks of serious or even fatal brain swelling or bleeding.

Medicine

Woman Who Received Pig Kidney Transplant Has It Removed (wired.com) 40

Due to complications with a mechanical heart pump, surgeons in New York removed a pig kidney from Lisa Pisano less than two months after transplanting it. The genetically engineered pig kidney did not show signs of rejection but suffered from inadequate blood flow. Wired reports: Pisano was facing heart and kidney failure and required routine dialysis. She wasn't eligible to receive a traditional heart and kidney transplant from a human donor because of several chronic medical conditions that reduced the likelihood of a good outcome. Pisano first received a heart pump at NYU Langone Health on April 4, followed by the pig kidney transplant on April 12. The heart pump, a device called a left ventricular assist device or LVAD, is used in patients who are either awaiting heart transplantation or otherwise aren't a candidate for a heart transplant.

In a statement provided to WIRED, Pisano's medical team explained that they electively removed the pig kidney on May 29-47 days after transplant -- after several episodes of the heart pump not being able to pass enough blood through the transplanted kidney. Steady blood flow is important so that the kidney can produce urine and filter waste. Without it, Pisano's kidney function began to decline. "On balance, the kidney was no longer contributing enough to justify continuing the immunosuppression regimen," said Robert Montgomery, director of the NYU Langone Transplant Institute, in the statement. Like traditional transplant patients, Pisano needed to take immunosuppressive drugs to prevent her immune system from rejecting the donor organ.

The kidney came from a pig genetically engineered by Virginia biotech company Revivicor to lack a gene responsible for the production of a sugar known as alpha-gal. In previous studies at NYU Langone, researchers found that removing this sugar prevented immediate rejection of the organ when transplanted into brain-dead patients. During Pisano's surgery, the donor pig's thymus gland, which is responsible for "educating" the immune system, was also transplanted to reduce the likelihood of rejection. A recent biopsy did not show signs of rejection, but Pisano's kidney was injured due to a lack of blood flow, according to the statement. The team plans to study the explanted pig kidney to learn more.

Biotech

Male Birth Control Gel Continues to Show Promise (gizmodo.com) 152

Gizmodo reports there's been progress on a male birth-control gel "being developed with the help of several organizations, including the U.S. government's National Institute of Child Health and Human Development, part of the larger NIH." It's now being tested in a larger-scale Phase IIB trial, which involves around 400 couples. [Five milliliters of gel — about a teaspon — is applied to each shoulder blade once a day, reports NBC News.] That trial is still ongoing, but researchers have already begun to pore through some of the available data, which has provided encouraging results. In the summer of 2022, for instance, Diana Blithe, chief of the NICHD's Contraceptive Development Program, reported that the NES/T gel's efficacy rate so far appeared to be on par or even better than contraceptive hormonal options for women...

The findings are still preliminary, and it will take more time for the full Phase II data to be collected and analyzed. But Blithe and her team have been encouraged by everything they've seen to date. In the team's early assessments, the gel appears to be both effective and safe, with minimal side effects for men taking it... Blithe and her colleagues are set to meet with the FDA next year about the steps needed to begin a larger Phase III trial and are still seeking a commercial partner to help bring the NES/T gel to the market.

Initial findings also showed that the contraceptive worked faster than expected, Blithe said, according to NBC News. They add that at least three other companies are also working on male birth control: Also at the Boston conference on Sunday, YourChoice Therapeutics said a very small trial in the U.K. — just 16 men — showed that its nonhormonal pill, YCT-529, was safe and free of side effects. The San Francisco company's nonhormonal pill works by blocking the vitamin A receptor important for male fertility.YourChoice is planning a larger trial, according to CEO Akash Bakshi.
Medicine

Ozempic-Like Drugs Could Lower Sales of Junk Food (yahoo.com) 120

Will appetite-suppressing drugs hurt the sugar industry? Executives from Walmart warned that Ozempic and Zepbound "are impacting food sales," reports Bloomberg, "and multiple analyst surveys have showed that less-hungry customers are spending fewer dollars at grocery stores and restaurants." The drugs, which cut cravings, will result in a decline in calorie consumption in the US of 1.5% to 2.5% by 2035, with a drop of as much as 5% in the consumption of sweets such as baked goods, confectionery and soda, Morgan Stanley analysts including Pamela Kaufman said in a report last month. Morgan Stanley forecast about a 10th of the US population will be on the so-called GLP-1 medications — originally designed to treat diabetes but being used by many as a powerful weight-loss tool — by 2035... Even with tight supplies and sky-high prices limiting uptake of the medications, sales of GLP-1 drugs for both obesity and diabetes already exceeded $19 billion in 2023. The global obesity market alone could top $100 billion by the end of the decade, Goldman Sachs Group Inc. estimates, while Bloomberg Intelligence forecasts $80 billion of sales.

More than 60% of US consumers taking the drugs said they had cut back on sweet treats like candy, ice cream and baked goods, and many said they had either significantly — or entirely — stopped eating those products, according to Morgan Stanley.

Biotech

Are We Closer to a Cure for Diabetes? (indiatimes.com) 75

"Chinese scientists develop cure for diabetes," reads the headline from the world's second-most widely read English-language newspaper. ("Insulin patient becomes medicine-free in just 3 months.")

The researchers' results were published earlier in May in Cell Discovery, and are now getting some serious scrutiny from the press. The Economic Times cites a University of British Columbia professor's assessment that the study "represents an important advance in the field of cell therapy for diabetes," in an article calling it a "breakthrough" that "marks a significant advancement in cell therapy for diabetes." Chinese scientists have successfully cured a patient's diabetes using a groundbreaking cell therapy... According to a South China Morning Post report, the patient underwent the cell transplant in July 2021. Remarkably, within eleven weeks, he no longer required external insulin. Over the next year, he gradually reduced and ultimately stopped taking oral medication for blood sugar control. "Follow-up examinations showed that the patient's pancreatic islet function was effectively restored," said Yin, one of the lead researchers. The patient has now been insulin-free for 33 months... The new therapy involves programming the patient's peripheral blood mononuclear cells, transforming them into "seed cells" to recreate pancreatic islet tissue in an artificial environment.
Their article calls it "a significant medical milestone" — noting that 140 million people in China have diabetes (according to figures from the International Diabetes Federation).

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

Alzheimer's Takes a Financial Toll Long Before Diagnosis, Study Finds (nytimes.com) 49

Long before people develop dementia, they often begin falling behind on mortgage payments, credit card bills and other financial obligations, new research shows. The New York Times: A team of economists and medical experts at the Federal Reserve Bank of New York and Georgetown University combined Medicare records with data from Equifax, the credit bureau, to study how people's borrowing behavior changed [PDF] in the years before and after a diagnosis of Alzheimer's or a similar disorder. What they found was striking: Credit scores among people who later develop dementia begin falling sharply long before their disease is formally identified. A year before diagnosis, these people were 17.2 percent more likely to be delinquent on their mortgage payments than before the onset of the disease, and 34.3 percent more likely to be delinquent on their credit card bills. The issues start even earlier: The study finds evidence of people falling behind on their debts five years before diagnosis.

"The results are striking in both their clarity and their consistency," said Carole Roan Gresenz, a Georgetown University economist who was one of the study's authors. Credit scores and delinquencies, she said, "consistently worsen over time as diagnosis approaches, and so it literally mirrors the changes in cognitive decline that we're observing." The research adds to a growing body of work documenting what many Alzheimer's patients and their families already know: Decision-making, including on financial matters, can begin to deteriorate long before a diagnosis is made or even suspected. People who are starting to experience cognitive decline may miss payments, make impulsive purchases or put money into risky investments they would not have considered before the disease.

Businesses

You Can Thank Private Equity for That Enormous Doctor's Bill 157

Private-equity investors have poured billions into healthcare but often game the system, hurting both doctors and patients. From a report: Consolidation is as American as apple pie. When a business gets bigger, it forces mom-and-pop players out of the market, but it can boost profits and bring down costs, too. Think about the pros and cons of Walmart and "Every Day Low Prices." In a complex, multitrillion-dollar system like America's healthcare market, though, that principle has turned into a harmful arms race that has helped drive prices increasingly higher without improving care. Years of dealmaking has led to sprawling hospital systems, vertically integrated health insurance companies, and highly concentrated private equity-owned practices resulting in diminished competition and even the closure of vital health facilities. As this three-part Heard on the Street series will show, the rich rewards and lax oversight ultimately create pain for both patients and the doctors who treat them. Belatedly, state and federal regulators and lawmakers are zeroing in on consolidation, creating uncertainty for the investors who have long profited from the healthcare merger boom.

Consider the impact of massive private-equity investment in medical practices. When a patient with employer-based insurance goes under for surgery, the anesthesiologist's fee is supposed to be determined by market forces. But what happens if one firm quietly buys out several anesthesiologists in the same city and then hikes the price of the procedure? Such a scheme was allegedly implemented by the private-equity firm Welsh, Carson, Anderson & Stowe and the company it created in 2012, U.S. Anesthesia Partners, according to a Federal Trade Commission lawsuit filed last year. It started by buying the largest practice in Houston and then making three further acquisitions, eventually expanding into other cities throughout the state of Texas. In each location, the lawsuit alleges, USAP pursued an aggressive strategy of eliminating competitors by either acquiring them or conspiring with them to weaken competition. As one insurance executive put it in the FTC lawsuit, USAP and Welsh Carson used acquisitions to "take the highest rate of all ... and then peanut butter spread that across the entire state of Texas." In May, U.S. District Judge Kenneth Hoyt dismissed the FTC's unusual step of charging the private-equity investor, Welsh Carson, but allowed the case against USAP to proceed.

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