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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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      Jill Stein’s Third-Party Candidacy

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      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

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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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      CVS Ousts Karen Lynch as C.E.O. and Shares Fall

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      Shares of the health care conglomerate dropped after the sudden departure of Karen Lynch and a downbeat update on the state of the company’s finances.CVS Health abruptly ousted its chief executive, Karen S. Lynch, on Friday as the pharmacy and health care conglomerate struggled with sluggish growth and faced pressure from investors.The company appointed David Joyner, the head of CVS Caremark, its successful unit overseeing prescription drug benefits, as the new chief. The management change was accompanied by a dour financial update, with the company scrapping its previous forecasts because of “elevated medical cost pressures.” Shares of CVS fell sharply in early trading.The company’s earnings have disappointed investors in recent quarters, in part because of rising costs at Aetna, the company’s insurance arm. Activist investors have pushed the company for changes, prompting CVS to explore breaking itself up, potentially by separating its pharmacy business from its insurance unit.CVS employs about 300,000 people. Its sprawling portfolio includes the branded pharmacy chain, with more than 9,000 retail locations; Aetna, which it acquired in 2018, which has nearly 40 million policyholders and other customers; Caremark, the country’s largest pharmacy benefit manager, hired by employers and governments to oversee prescription drug benefits; and Oak Street Health, which runs more than 200 primary care centers for Medicare recipients.Ms. Lynch took over as the group’s chief executive in February 2021, after running Aetna. “I don’t want people to think about CVS Health as just that drugstore,” she told The New York Times in 2022. “I want them to think about it being a health care company.”Roger Farah, the chairman of CVS Health, said in a statement on Friday that “the board believes this is the right time to make a change.” He added that Mr. Joyner’s “deep understanding of our integrated business” would help steer the company through its challenges.During his tenure at Caremark, which he rejoined in 2023 after a few years away from the company, Mr. Joyner faced increased scrutiny of pharmacy benefit managers. He appeared at a Congressional hearing this summer, facing questions from lawmakers about the role of pharmacy benefit managers in rising drug costs for millions of Americans.This month, CVS said it would cut almost 3,000 jobs, mostly corporate employees. Its rival chains are also under pressure to cut costs: This week, Walgreens said it would close about 1,200 stores over the next three years.Shares of CVS, which dropped 7 percent on Friday, have fallen more than 25 percent this year. More

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      Zantac’s Developer Settles Lawsuits Claiming Cancer Link

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      GSK, which developed and sold versions of the now-discontinued blockbuster heartburn drug, agreed to pay up to $2.2 billion.The British drug maker GSK said on Wednesday that it would pay up to $2.2 billion to settle most of the lawsuits filed against it by people who claim that they developed cancer after taking a now-discontinued blockbuster heartburn drug commonly known by the brand name Zantac.GSK, which developed the drug decades ago and sold a version of it until 2017, did not admit liability in settling the cases. The evidence is mixed on whether the drug elevates the risk of cancer, but the concern that the drug might was sufficient to get it removed from the market.An over-the-counter medication sold today as Zantac 360 by Sanofi has a different active ingredient from the withdrawn versions of Zantac and has not raised questions about a cancer link.In 2019, the Food and Drug Administration said it had detected low levels of a cancer-causing contaminant known as NDMA in samples of Zantac, which at that time was widely sold by prescription and over the counter. Manufacturers soon voluntarily withdrew their versions of the drug, and pharmacies pulled the products from their shelves.The next year, the F.D.A. recommended that the drug no longer be sold or used, saying that when stored for long periods its active ingredient can degrade and cause a buildup of NDMA, creating a danger of cancer.Other research has found that Zantac users were no more likely to develop cancer than people who took other drugs that suppress the production of stomach acid.Tens of thousands of Zantac users have filed product liability lawsuits against GSK and other makers of versions of Zantac. This year, juries in Illinois that heard the first few such cases sided with the manufacturers or failed to reach a verdict.Several other pharmaceutical companies that previously sold versions of the drug, including Sanofi and Pfizer, reached similar settlements this year. Boehringer Ingelheim, a former manufacturer that has not settled, is in court in California this week defending itself in a jury trial brought by a man who claims that over-the-counter Zantac caused his bladder cancer.GSK’s settlement on Wednesday will resolve claims by about 80,000 plaintiffs in the United States. The company said it had also agreed to pay $70 million to settle a whistle-blower complaint by an independent laboratory, Valisure, whose testing first raised the alarm about a link between Zantac and cancer. In that lawsuit, Valisure accused GSK of knowing that the drug elevates cancer risk and of keeping quiet about it.The suit was unsealed this year after the Justice Department declined to either join the suit or recommend that it be dismissed. The company denies Valisure’s allegations. 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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      First Day of a ‘New Life’ for a Boy With Sickle Cell

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      There was supposed to be a special party for Kendric Cromer, 12, last Wednesday, but it had to be postponed because he was too groggy to celebrate.It was meant to mark the first day of his new life — the day he became one of the first children ever to be treated with a newly approved gene therapy that will free him from the sickle cell disease that has stolen his childhood.On Sept. 11, despite the excitement of the moment, Kendric was unable to keep his eyes open as he lay in his hospital bed at Children’s National Hospital in Washington because of the drugs he had been given in preparation for his treatment.His life with the disease has been punctuated by episodes of excruciating pain, requiring days in the hospital as doctors tried to control it. Sickle cell eroded his hip bones. It prevented him from riding a bike or playing soccer or even going outside when the temperature was below 55 degrees Fahrenheit because cold often brought on intense pain.Now he could see a future — in a month or so — without pain from sickle cell.“I can’t wait to start my new life,” he told his mother, Deborah Cromer.His disease is caused by an inherited genetic mutation that leads to blood cells that form crescent shapes — sickles — instead of discs. Trapped in blood vessels and organs, the cells cause damage and pain. Gene therapy fixes that problem by giving the patient a new, normal hemoglobin gene.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