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    Drugs Have Uses We Can’t Imagine. He’s Using A.I. to Find Them.

    A little over a year ago, Joseph Coates was told there was only one thing left to decide. Did he want to die at home, or in the hospital?Coates, then 37 and living in Renton, Wash., was barely conscious. For months, he had been battling a rare blood disorder called POEMS syndrome, which had left him with numb hands and feet, an enlarged heart and failing kidneys. Every few days, doctors needed to drain liters of fluid from his abdomen. He became too sick to receive a stem cell transplant — one of the only treatments that could have put him into remission.“I gave up,” he said. “I just thought the end was inevitable.”But Coates’s girlfriend, Tara Theobald, wasn’t ready to quit. So she sent an email begging for help to a doctor in Philadelphia named David Fajgenbaum, whom the couple met a year earlier at a rare disease summit.By the next morning, Dr. Fajgenbaum had replied, suggesting an unconventional combination of chemotherapy, immunotherapy and steroids previously untested as a treatment for Coates’s disorder.Within a week, Coates was responding to treatment. In four months, he was healthy enough for a stem cell transplant. Today, he’s in remission.The lifesaving drug regimen wasn’t thought up by the doctor, or any person. It had been spit out by an artificial intelligence model.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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    How Much Should Weight Loss Drugs Like Wegovy and Zepbound Cost?

    A new study found that fair prices for medications like Wegovy and Zepbound would be hundreds less per month than they are now.It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)“There’s no doubt that the drugs are demonstrating tremendous health benefits,” said David Kim, a health economist at the University of Chicago and the senior author of the study, which was funded by government grants. “The problem is the price is too high.”There’s widespread hope that the drugs will effectively pay for themselves in the long run, by making patients healthier and preventing expensive medical bills. It’s not clear yet whether that will turn out to be true.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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    F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia

    Federal regulators will no longer require patients to provide blood tests before receiving the drug from pharmacies.The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that the drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening.In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.Physicians have long complained that, as a result, clozapine is grossly underutilized.Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”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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    Dr Martin Makary Chosen to Head the FDA

    President-elect Donald J. Trump announced on Friday that he would nominate Dr. Martin A. Makary, a Johns Hopkins University surgeon with a contrarian streak, to be commissioner of the Food and Drug Administration.In a post on social media, Mr. Trump said: “F.D.A. has lost the trust of Americans and lost sight of its primary goal as a regulator.” He said that Dr. Makary would work under Robert F. Kennedy Jr., the president-elect’s choice for the cabinet-level role as health secretary, to “properly evaluate harmful chemicals poisoning our nation’s food supply and drugs.”“I am confident that Dr. Makary, having dedicated his career to high-quality, lower-cost care will restore the F.D.A. to the gold standard of scientific research and cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Mr. Trump said in a statement.Mr. Trump announced two other top health picks on Friday evening as well. He chose Dr. Dave Weldon, a physician and former congressman from Florida, to lead the Centers for Disease Control and Prevention.For years, Dr. Weldon championed the notion that thimerosal, a preservative once used widely in vaccines, caused an explosion of autism cases around the world. In 2007, he backed a bill proposing to take vaccine safety research out of the hands of the C.D.C. Health officials reject the idea that research shows any link between thimerosal and autism.Mr. Trump also put forward Dr. Janette Nesheiwat, a physician and Fox News contributor, to be surgeon general. She worked caring for patients after Hurricane Katrina, an announcement from Mr. Trump said, and on the front lines of the Covid pandemic in New York City. She also markets vitamin B and vitamin C dietary supplements.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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    The New York Times Presents: ‘Weight of the World’ on Ozempic’s Rise

    ‘Weight of the World’Producer/Director Esther Dere and Nicole RittenmeyerCo-Producer Leah VarjacquesProducer/Reporter Dani BlumProducer Rachel AbramsWatch our new documentary on FX and Hulu starting Friday, Nov. 22, at 10 p.m. Eastern.The ascent of GLP-1 medications, such as Ozempic, has brought about a transformation within the weight-loss industry and beyond, reshaping societal views on health and body image. Originally developed to manage diabetes, these drugs have become associated with rapid weight reduction, capturing public interest thanks to rumored endorsements from high-profile figures like Oprah Winfrey and Elon Musk.“Weight of the World” dives into this pivotal moment, following the journeys of three individuals as they navigate the complexities of using GLP-1 medications. The film examines their experiences against the backdrop of over 40 years of diet culture in America, prompting an inquiry into whether these medications represent a groundbreaking shift or merely another chapter in the long and complicated narrative of weight loss.Through expert commentary from medical professionals, dietitians and cultural critics, the film looks at this evolving landscape, and it investigates the societal obsession with thinness and the implications of these new pharmaceutical interventions, raising questions about body image, health and the ongoing struggle against obesity.Left Right Productions/The New York Times/Hulu Originals/FX Networks”GLP-1s are a blockbuster because they promise to solve a social problem without changing anything else.”Tressie McMillan Cottom, Times Opinion columnistLeft Right Productions/The New York Times/Hulu Originals/FX Networks“Thinking about weight is probably the No. 1 item that’s on my mind most of the time. Like, I’m always comparing myself to everyone around me.”Jeffrey Luxmore, a subject featured in the filmSupervising Producer Liz HodesDirector Of Photography Victor Tadashi SuarezVideo Editor Geoff O’Brien“The New York Times Presents” is a series of documentaries representing the unparalleled journalism and insight of The New York Times, bringing viewers close to the essential stories of our time. More

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    Kennedy’s Views Mix Mistrust of Business With Bizarre Health Claims

    Seven years after Americans celebrated the licensing of Jonas Salk’s polio vaccine, President John F. Kennedy called on Congress to finance a nationwide vaccination program to stamp out what he called the “ancient enemies of our children”: infectious disease.Now Kennedy’s nephew, Robert F. Kennedy Jr., is the nation’s chief critic of vaccines — a public health intervention that has saved millions of lives — and President-elect Donald J. Trump’s pick to become the next secretary of health and human services. Mr. Kennedy calls himself a vaccine safety activist. The press calls him a vaccine skeptic. His detractors call him an anti-vaxxer and a conspiracy theorist.Whatever one calls him, Mr. Kennedy is a polarizing choice whose views on certain public health matters beyond vaccination are far outside the mainstream. He opposes fluoride in water. He favors raw milk, which the Food and Drug Administration deems risky. And he has promoted unproven therapies like hydroxychloroquine for Covid-19. His own relatives called his presidential bid “dangerous for our country.”If there is a through line to Mr. Kennedy’s thinking, it appears to be a deep mistrust of corporate influence on health and medicine. In some cases, that has led him to support positions that are also embraced by public health professionals, including his push to get ultra-processed foods, which have been linked to obesity, off grocery store shelves. His disdain for profit-seeking pharmaceutical manufacturers and food companies drew applause on the campaign trail.People close to him say his commitment to “make America healthy again” is heartfelt.“This is his life’s mission,” said Brian Festa, a founder of We the Patriots U.S.A., a “medical freedom” group that has pushed back on vaccine mandates, who said he has known Mr. Kennedy for years.But like Mr. Trump, Mr. Kennedy also has a tendency to float wild theories based on scanty evidence. And he has hinted at taking actions, like prosecuting leading medical journals, that have unnerved the medical community. On Friday, many leading public health experts reacted to his nomination with alarm.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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    From AI to Musk’s Brain Chip, the F.D.A.’s Device Unit Faces Rapid Change

    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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    Jill Stein’s Third-Party Candidacy

    More from our inbox:Harris’s AdsDrug-Free TreatmentsRegretting Email, and Other Modern MusingsJill Stein, the Green Party’s candidate for president, after a campaign event in Dearborn, Mich., earlier in October.Nic Antaya for The New York TimesTo the Editor:Re “She’s Still Running for President, No Matter Who Asks Her to Stop” (front page, Oct. 20):I just came back from the grocery store in Philadelphia, where I live. On the street corner opposite the store was a sign that said something like “Demand more from Harris or I am voting for Jill Stein.” At the bottom it said the sign was from the progressive cause.Make no mistake: Anyone who votes for Ms. Stein because they think Kamala Harris isn’t progressive enough is really voting for Donald Trump. This is Pennsylvania, for heaven’s sake, which many believe is the most critical swing state. And where the race is thought to be very, very close.If progressives are really committed to their cause, they can’t vote for Ms. Stein in Pennsylvania. Massachusetts maybe — where it doesn’t matter. But not here. (Progressives can’t really think they will get closer to their policy goals with Donald Trump!)We can’t afford another Florida 2000, when the votes for Ralph Nader may have cost Al Gore the election. The stakes are too high.Stephen M. DavidsonPhiladelphiaTo the Editor:The platform of the Green Party includes as one of its “four pillars”: “Ecology: The human cost of climate change is too high. We need to get off fossil fuels and on to renewable energy.”The candidacy of Jill Stein, the Green Party nominee, could hand Donald Trump the presidency. Mr. Trump, in his stint in the White House tweeted, “The concept of global warming was created by and for the Chinese in order to make U.S. manufacturing non-competitive.”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