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      From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

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      The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it.Medical device technology is now deeply entrenched in many patients’ health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.’s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren’s wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny.Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.U.S. Food and Drug AdministrationMore broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry’s influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division’s mission in the coming years. Among the issues Dr. Tarver will encounter:Brains, computers and Elon MuskFew devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise — and return function to people who have lost it.Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      They Barter and Trade in Rural America. How Will They Vote?

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      Many rural Americans engage in cashless barter systems to get food and firewood for heating and cooking. They value self-sufficiency, making them wary of government intervention.When Miki Shiverick needs firewood to heat her home, or help clearing the rusted appliances and vehicles from her property, she doesn’t go to a store or pay for services. Instead, she trades for it.For instance, preparing her land in Bergholz, Ohio for livestock over the last four years required hauling away piles of salvage, old tools and antiques from the rundown property she bought from the family of an old tinker. The place, with its barn house and five outbuildings, resembled a 12-acre junkyard.Ms. Shiverick, 56, found local scrappers willing to keep the profits from selling the rusted cars, campers, tractor parts, buried gas tanks and aluminum ingots at the local scrap yard. She also found woodsmen willing to clear trees for her in exchange for most of the wood.On this newly blank canvas, she dreams of creating a clean, natural retreat for her family with gardens that support wildlife and livestock, which she raises to promote food self-sufficiency and land stewardship.Bergholz is a rural town with a population of fewer than 600. For centuries, rural communities like Bergholz have operated in cashless barter systems built on mutual trust and neighborly relationships — a culture of self-sufficiency that has also shaped political views toward a kind of bootstrap conservatism.“People around here don’t do welfare, it’s not who we are,” Ms. Shiverick said.Ms. Shiverick bartered a bolt of linen with an Amish neighbor for a chicken coop.Rebecca Kiger for The New York TimesWe are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      U.S. Study on Puberty Blockers Goes Unpublished Because of Politics, Doctor Says

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      The leader of the long-running study said that the drugs did not improve mental health in children with gender distress and that the finding might be weaponized by opponents of the care.An influential doctor and advocate of adolescent gender treatments said she had not published a long-awaited study of puberty-blocking drugs because of the charged American political environment.The doctor, Johanna Olson-Kennedy, began the study in 2015 as part of a broader, multimillion-dollar federal project on transgender youth. She and colleagues recruited 95 children from across the country and gave them puberty blockers, which stave off the permanent physical changes — like breasts or a deepening voice — that could exacerbate their gender distress, known as dysphoria.The researchers followed the children for two years to see if the treatments improved their mental health. An older Dutch study had found that puberty blockers improved well-being, results that inspired clinics around the world to regularly prescribe the medications as part of what is now called gender-affirming care.But the American trial did not find a similar trend, Dr. Olson-Kennedy said in a wide-ranging interview. Puberty blockers did not lead to mental health improvements, she said, most likely because the children were already doing well when the study began.“They’re in really good shape when they come in, and they’re in really good shape after two years,” said Dr. Olson-Kennedy, who runs the country’s largest youth gender clinic at the Children’s Hospital of Los Angeles.That conclusion seemed to contradict an earlier description of the group, in which Dr. Olson-Kennedy and her colleagues noted that one quarter of the adolescents were depressed or suicidal before treatment.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      ‘No Smoking’ Sign on Planes Won’t Need Off Switch After FAA Rule Change

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      The Federal Aviation Administration did away with a rule that had required an off switch for the sign even though smoking on U.S. flights ended years ago.The days of airplane cabins hazy with cigarette smoke are long gone, but a reminder of that era is still visible inside commercial jets.Smoking has been banned on commercial flights in the United States for decades, but the Federal Aviation Administration is only just updating an outdated rule to reflect that reality. Starting on Tuesday, the illuminated overhead “No Smoking” sign no longer requires an off switch.That obsolete requirement had become “time-consuming and burdensome” for airlines and airplane manufacturers to comply with, the F.A.A. said in a rule enacting the change. In February, for example, United Airlines was briefly unable to use a handful of new Airbus planes because the “No Smoking” signs on board couldn’t be shut off, causing the airline to delay a few flights. The issue was resolved after the F.A.A. granted United an exemption.Dozens of such exemptions have allowed that requirement to live on while the agency focused on more pressing matters. But the long life of the mandate also reflects how entangled smoking once was with commercial flights, which began in the 1910s.“The rise of aviation literally parallels the rise of the cigarette,” said Alan Blum, the director of the University of Alabama’s Center for the Study of Tobacco and Society.Pipes, cigars and chewing tobacco were once more popular than cigarettes, but that began to change in the early 20th century, according to Dr. Blum. During World War I, cigarettes were added to rations for American soldiers fighting abroad.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      What Is Considered ‘Moderate Drinking’?

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      That depends on whom you ask, and what country you live in. Here’s what the research suggests and how to think about it.Over the past several years, there has been a rise in alcohol-related deaths and a steady wave of news about the health risks of drinking. Calls for people to drink only in moderation have become more urgent. But what, exactly, does that mean?“Tongue in cheek, people have defined it as not drinking more than your doctor,” said Tim Stockwell, a scientist at the Canadian Institute for Substance Use Research.More officially, in the United States, moderate drinking is defined as one drink or less per day for women and two drinks or less per day for men. But other countries define moderate drinking, also called low-risk drinking, differently, and recent research around alcohol’s health harms has raised questions about current guidelines.How are the guidelines set?Experts used to think that low or moderate amounts of alcohol were good for you. That assumption was based on research showing that people who drank in moderation lived longer than those who abstained or drank excessively. The longevity benefit disappeared around two drinks a day for women and three drinks a day for men, Dr. Stockwell said.But many researchers now think that those conclusions were based on data analyses that had “all kinds of methodological problems,” said Elizabeth Mayer-Davis, a professor of nutrition and medicine at the University of North Carolina, Chapel Hill.For example, one issue was that many people who abstained from alcohol did so because they had existing health problems, while people who drank moderately were more likely to have healthy lifestyle habits. It created “really what was an illusion of health benefits with low to moderate amounts of drinking,” Dr. Mayer-Davis said.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Trump prometió hacer público su historial médico pero sigue sin hacerlo

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      Si vuelve a ser elegido, se convertirá en el presidente de mayor edad al final de su mandato. Sin embargo, se niega a revelar incluso la información médica básica.[Estamos en WhatsApp. Empieza a seguirnos ahora]Como candidato presidencial en 2015, Donald Trump se negó a publicar su historial médico, ofreciendo en su lugar una carta de cuatro párrafos de su médico personal en la que proclamaba que sería “la persona más sana jamás elegida para la presidencia”.En 2020, cuando estuvo hospitalizado por COVID-19 y se presentaba a la reelección, los médicos de Trump dieron una información mínima sobre su estado, que, según se supo más tarde, fue mucho más grave de lo que dejó entrever las descripciones públicas.En 2024, días antes de convertirse en el candidato presidencial republicano oficial por tercera vez, fue rozado por una bala de un posible asesino, pero su campaña no celebró una sesión informativa sobre su estado, no publicó los registros hospitalarios ni puso a disposición a los médicos de urgencias que lo trataron para ser entrevistados.Ahora, a poco más de un mes de unas elecciones que podrían convertir a Trump, de 78 años, en la persona de mayor edad en ocupar la presidencia (82 años, 7 meses y 6 días cuando su mandato termine en enero de 2029), se niega a revelar incluso la información más básica sobre su salud.Si gana, Trump podría entrar en el Despacho Oval con una serie de problemas potencialmente preocupantes, según los expertos médicos: factores de riesgo cardíaco, posibles secuelas del intento de asesinato de julio y el deterioro cognitivo que se produce de forma natural con la edad, entre otros.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor Countries

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      Many middle-income countries are left out of the deal, widening a gulf in access to critical medicines.The drugmaker Gilead Sciences on Wednesday announced a plan to allow six generic pharmaceutical companies in Asia and North Africa to make and sell at a lower price its groundbreaking drug lenacapavir, a twice-yearly injection that provides near-total protection from infection with H.I.V.Those companies will be permitted to sell the drug in 120 countries, including all the countries with the highest rates of H.I.V., which are in sub-Saharan Africa. Gilead will not charge the generic drugmakers for the licenses.Gilead says the deal, made just weeks after clinical trial results showed how well the drug works, will provide rapid and broad access to a medication that has the potential to end the decades-long H.I.V. pandemic.But the deal leaves out most middle- and high-income countries — including Brazil, Colombia, Mexico, China and Russia — that together account for about 20 percent of new H.I.V. infections. Gilead will sell its version of the drug in those countries at higher prices. The omission reflects a widening gulf in health care access that is increasingly isolating the people in the middle.Gilead charges $42,250 per patient per year for lenacapavir in the United States, where it is approved as a treatment for H.I.V. The company has said nothing about what lenacapavir will cost when used to prevent H.I.V. infections, a process called pre-exposure prophylaxis, or PrEP.The generics makers — four companies in India, one in Pakistan and one in Egypt — are expected to sell it for much less. Researchers at Liverpool University found the drug could profitably be produced for as little as $40 per patient per year, if it were being purchased in large volumes.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      A Week of Chaos Pushes Lebanon’s Doctors to the Limit

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      Dr. Dania El-Hallak was already exhausted. After wireless devices exploded across Lebanon, there had been little time to process what she had seen — the hundreds of wounded, many of their faces disfigured beyond recognition.“I am hoping that it was all just a bad dream,” Dr. El-Hallak said, still struggling to take stock of the carnage on Friday.Then, without warning, Israeli fighter jets ripped through the skies above Lebanon’s capital.“There are strikes in Dahiya?” she said in disbelief, using the Arabic name for Beirut’s southern suburbs.Her nightmare had only just begun.The attacks on Hezbollah’s communication devices this week — widely attributed to Israel — wounded thousands of people, leaving many of them permanently disabled and in need of long-term rehabilitative care. The Israeli airstrike just miles from downtown Beirut on Friday, which killed at least 37 people and injured dozens more, has only added to the toll. Others are still presumed trapped in the debris.Lebanon’s ailing health system — already embattled by a crippling economic collapse — has been sent into overdrive.Dr. Ghassan Abu Sitta at his home in London in December. He volunteered last year at a burn unit in Gaza and now believes war will come to Lebanon. Mary Turner for The New York TimesWe are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More