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    Why Patients Are Being Forced to Switch to a 2nd-Choice Obesity Drug

    CVS Caremark decided to stop offering Zepbound in favor of Wegovy for weight loss. It’s the latest example of limits imposed by insurance that disrupt treatments for patients.Tens of thousands of Americans will soon be forced by their health insurance to switch from one popular obesity drug to another that produces less weight loss.It is the latest example of the consequences of secret deals between drugmakers and middlemen, known as pharmacy benefit managers, that are hired by employers to oversee prescription coverage for Americans. Employers pay lower drug prices but their workers are blocked from getting competing treatments, a type of insurance denial that has grown much more common in the past decade.One of the largest benefit managers, CVS Health’s Caremark, made the decision to exclude Zepbound in spite of research that found that it resulted in more weight loss than Wegovy, which will continue to be covered.Those research findings, first announced in December, were confirmed in an article published on Sunday in The New England Journal of Medicine. The study involved a large clinical trial comparing the drugs that was funded by Eli Lilly, the maker of Zepbound. Earlier research not financed by Eli Lilly reached similar conclusions.Ellen Davis, 63, of Huntington, Mass., is one of the patients affected by Caremark’s decision. “It feels like the rug is getting pulled out from under my feet,” she said.After taking Zepbound for a year, she has lost 85 pounds and her health has improved, she said. She retired after working for 34 years at Verizon, which hired Caremark for her drug coverage.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 Ivermectin Can (and Can’t) Do

    Social media posts have promoted the anti-parasitic drug for cancer and Covid. That has doctors alarmed.At least once a week, someone asks Dr. Skyler Johnson if ivermectin can treat their cancer.Patients have asked about the anti-parasitic drug for years, especially during the pandemic. But in recent months, Dr. Johnson, a radiation oncologist at the University of Utah Huntsman Cancer Institute, has fielded more and more questions about the medication.Exaggerated and inaccurate comments about ivermectin have intensified online lately. Google searches for “ivermectin” hit their highest point in January since a Covid wave in 2022. That month, the actor Mel Gibson appeared on the hit podcast “The Joe Rogan Experience” and said that three friends with Stage 4 cancer recovered after taking ivermectin, among other drugs. Researchers said the podcast, which received 10 million views on YouTube alone, fed into a flood of inaccurate claims and misinformation about the drug’s purported health benefits.At the same time, politicians in several states are promoting legislation that would make it easier for people to obtain ivermectin. The governor of Arkansas signed a bill last week that would enable people to buy it without a prescription. Lawmakers in Georgia, Texas, West Virginia, Alabama, Louisiana and Kentucky have filed, or said they plan to file, similar legislation. A wealth of research has shown the drug does not treat Covid. And there is not evidence to support people taking ivermectin to treat cancer.“I understand that people, a lot of times, want to take health into their own hands — they want to figure things out on their own,” said Krissy Lunz Trujillo, an assistant professor of political science at the University of South Carolina who researches health misinformation. “But that might have really serious consequences.”Dr. Johnson worries that people will forgo traditional cancer treatments for a drug that hasn’t been proven to work. He tells patients that there is no rigorous research showing the anti-parasitic drug cures cancer in humans. Still, he has seen some people with early, treatable tumors turn to the drug, and return months later with cancers that have spread to their lymph nodes, bones and brain.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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    Heart-Valve Patients Should Have Earlier Surgery, Study Suggests

    The results of a new clinical trial have overturned the “wait and see” approach that cardiologists have long favored for symptom-free patients.For decades, people with failing heart valves who nevertheless felt all right would walk out of the cardiologist’s office with the same “wait and see” treatment plan: Come back in six or 12 months. No reason to go under the knife just yet.A new clinical trial has overturned that thinking, suggesting that those patients would be much better off having their valves replaced right away with a minimally invasive procedure.The trial, whose results were published this week in The New England Journal of Medicine, could change the way doctors treat severe aortic stenosis, a narrowing of the valve that controls blood flow from the heart. The disease, which has a prognosis worse than that of most cancers, afflicts more than 3 percent of people ages 65 and older. It is expected to become more common as people live longer.Replacing people’s heart valves, even if they were not yet experiencing any ill effects, appeared to roughly halve their risk of being unexpectedly hospitalized for heart problems over at least two years, the trial found.Patients who were put on the more conservative treatment plan overwhelmingly ended up needing surgery anyway: Roughly 70 percent of them developed symptoms and needed to have their valves replaced within two years, suggesting that the disease worsens more quickly than previously understood.“You may be able to at least prevent that progression and perhaps improve patient outcomes by treating earlier,” said Dr. Gregg Stone, a professor of medicine at the Icahn School of Medicine at Mount Sinai, describing the implications of the trial. The findings, he said, “will have a major effect on practice.”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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    Francisco Lopera, the ‘Country Doctor’ Who Upended Our Understanding of Dementia

    Francisco Lopera defied rebels, cartels and vampire bats to become a pioneering researcher of Alzheimer’s disease.In 1978, Dr. Francisco Lopera did what recent medical school graduates in Colombia and much of Latin America have long done: He set out for an obligatory year of work in a remote part of the country, where an inexperienced médico rural might be the only physician for miles. Dr. Lopera, who was born in the Andean region of Antioquia and knew mostly mountains and farm life before medical school, carried out his service in the Darién Gap, on the Caribbean coast near Panama.There Dr. Lopera, a groundbreaking Colombian Alzheimer’s researcher who died this week at age 73, treated stabbings, snakebites, complicated births, burns and fevers in a hospital that had electricity for only half the day. On one occasion, he was kidnapped by Marxist guerrillas. Another time, he had to flee gunshots.When I met Dr. Lopera in 2017, to start research on a book about the families with Alzheimer’s that became his life’s work, he told me a story about two young brothers who had died one after the other in his hospital, of unknown causes. Lopera traveled to the family home in a remote jungle clearing, where he discovered that the boys’ surviving siblings had bites on their fingers from vampire bats. He sent the bodies to a pathology lab hours away by boat, and the pathologists confirmed rabies. When the government brought in a rabies expert to investigate, Dr. Lopera joined him.He left that experience — long nights in the rainforest, searching for hidden roosts, engrossed in the natural history of rabies and bats — wanting to become a rabies epidemiologist. But that was not to be. His interests were eclectic and quick to change, and a few years later he became a neurology resident in Medellín.In 1984, Dr. Lopera examined a farmer in his 40s who appeared to have dementia. Dr. Lopera took again the unusual step of traveling to the family home, in a mountain hamlet like the one where he had been born. Not just the farmer had symptoms of dementia, he saw — a brother also appeared to be affected. Dr. Lopera had discovered what would turn out to be the world’s largest family with early-onset Alzheimer’s disease. The family shared a genetic mutation, later nicknamed the paisa mutation, that was unique to their region of Colombia. Dr. Lopera spent the next four decades studying the family’s 6,000 members.Dr. Francisco Lopera, second from right, in Yarumal, Colombia, in 2010, with Oderis Villegas, center, who was showing signs of Alzheimer’s disease at age 50. A sister, María Elsy, left, had a more advanced case.Todd Heisler/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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    Three MDMA Studies Are Retracted by Scientific Journal

    The journal Psychopharmacology has retracted three papers about MDMA-assisted therapy based on what the publication said was unethical conduct at one of the study sites where the research took place.Several of the papers’ authors are affiliated with Lykos Therapeutics, the drug company whose application for MDMA-assisted therapy to treat post-traumatic stress disorder was rejected last week by the Food and Drug Administration. The company said the research in the retracted papers was not part of its application to the F.D.A. In declining to approve Lykos’s application, the agency cited concerns about missing data and problems with the way the company’s study was designed, according to a statement released by Lykos on Friday.The F.D.A. has asked Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine to win approval by federal regulators. Lykos has said it would appeal the decision.The journal retraction was first reported by Stat, the health and medical news website.On Sunday, Lykos said that it disagreed with Psychopharmacology’s decision and that it would file an official complaint with the Committee on Publication Ethics, a nonprofit that sets guidelines for academic publications.“The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” the company said in the statement.The incident cited by Psychopharmacology has been well documented. In 2015, an unlicensed Canadian therapist who took part in the trial engaged in a sexual relationship with a participant after the conclusion of the trial’s dosing sessionsIn civil court documents, the patient, Meaghan Buisson, said she was sexually assaulted by the therapist, Richard Yensen, who at the time was working alongside his wife, a licensed therapist. Mr. Yensen has said the relationship was consensual and initiated by Ms. Buisson. Six months after the final session, she moved from Vancouver to Cortes Island, in British Columbia, where the couple lived, according to court documents. The relationship between patient and practitioner continued for more than a year, the documents said. Professional associations in both Canada and the United States prohibit sexual relationships between psychologists and patients for at least two years after their final session. The incident helped highlight some of the challenges associated with psychedelic medicine, which can render patients especially vulnerable during dosing sessions. For that reason, most clinical trials involving psychedelic compounds require the presence of two mental health professionals. (Lykos’s trials with MDMA require only one of the practitioners to be licensed.)The Multidisciplinary Association for Psychedelic Studies, or MAPS, is the nonprofit that carried out the research and later created Lykos to market its proprietary MDMA-assisted therapy. The association publicly acknowledged the incident in 2019, adding that it had been reported to the F.D.A. and to Canadian health authorities.The company acknowledged on Sunday that it had failed to notify Psychopharmacology about the violations, but it said that the oversight should have been addressed through a correction, not a retraction. More

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    FDA Declines to Approve MDMA Therapy, and Seeks Further Study

    The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy.The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments.The F.D.A. said there was insufficient data to allow its use, and it asked the company seeking approval for the treatment, Lykos Therapeutics, to conduct an additional clinical trial to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.An additional clinical trial could add years, and millions of dollars, to the approval process.If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. Supporters of psychedelic medicine were deeply disappointed, and some said they were stunned, having assumed the therapy’s promising data would overcome flaws in the company’s clinical trials, which had been designed in consultation with F.D.A. scientists.“This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics. His book, “How to Change Your Mind,” helped catalyze public interest in the therapeutic potential of psychoactive compounds, demonized during the nation’s long war on drugs.But the agency’s decision had not been entirely unexpected, after a group of independent experts convened by the F.D.A. to evaluate Lykos’s data met in June and did not recommend the treatment. On two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that the drug therapy’s benefits did not outweigh the risks.The agency generally follows the recommendations of its outside panels. Critics, however, have questioned the panel’s expertise, noting that only one of its 11 members had experience in psychedelic medicine.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 Blood Test Accurately Diagnosed Alzheimer’s 90% of the Time, Study Finds

    It was much more accurate than primary care doctors using cognitive tests and CT scans. The findings could speed the quest for an affordable and accessible way to diagnose patients with memory problems.Scientists have made another major stride toward the long-sought goal of diagnosing Alzheimer’s disease with a simple blood test. On Sunday, a team of researchers reported that a blood test was significantly more accurate than doctors’ interpretation of cognitive tests and CT scans in signaling the condition.The study, published Sunday in the journal JAMA, found that about 90 percent of the time the blood test correctly identified whether patients with memory problems had Alzheimer’s. Dementia specialists using standard methods that did not include expensive PET scans or invasive spinal taps were accurate 73 percent of the time, while primary care doctors using those methods got it right only 61 percent of the time.“Not too long ago measuring pathology in the brain of a living human was considered just impossible,” said Dr. Jason Karlawish, a co-director of the Penn Memory Center at the University of Pennsylvania who was not involved in the research. “This study adds to the revolution that has occurred in our ability to measure what’s going on in the brain of living humans.”The results, presented Sunday at the Alzheimer’s Association International Conference in Philadelphia, are the latest milestone in the search for affordable and accessible ways to diagnose Alzheimer’s, a disease that afflicts nearly seven million Americans and over 32 million people worldwide. Medical experts say the findings bring the field closer to a day when people might receive routine blood tests for cognitive impairment as part of primary care checkups, similar to the way they receive cholesterol tests.“Now, we screen people with mammograms and PSA or prostate exams and other things to look for very early signs of cancer,” said Dr. Adam Boxer, a neurologist at the University of California, San Francisco, who was not involved in the study. “And I think we’re going to be doing the same thing for Alzheimer’s disease and hopefully other forms of neurodegeneration.”In recent years, several blood tests have been developed for Alzheimer’s. They are currently used mostly to screen participants in clinical trials and by some specialists like Dr. Boxer to help pinpoint if a patient’s dementia is caused by Alzheimer’s or another condition.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 Shot Provides Total Protection From HIV in Trial of Young African Women

    An injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates.Researchers and activists in the trenches of the long fight against H.I.V. got a rare piece of exciting news this week: Results from a large clinical trial in Africa showed that a twice-yearly injection of a new antiviral drug gave young women total protection from the virus.“I got cold shivers,” said Dr. Linda-Gail Bekker, an investigator in the trial of the drug, lenacapavir, describing the startling sight of a line of zeros in the data column for new infections. “After all our years of sadness, particularly over vaccines, this truly is surreal.”Yvette Raphael, the leader of a group called Advocacy for Prevention of H.I.V. and AIDS in South Africa, said it was “the best news ever.”The randomized controlled trial, called Purpose 1, was conducted in Uganda and South Africa. It tested whether the every-six-months injection of lenacapavir, made by Gilead Sciences, would provide better protection against H.I.V. infection than two other drugs in wide use in high-income countries, both daily pills.The results were so convincing that the trial was halted early at the recommendation of the independent data review committee, which said all participants should be offered the injection because it clearly provided superior protection against the virus.None of the 2,134 women in the arm of the trial who received lenacapavir contracted H.I.V. By comparison, 16 of the 1,068 women (or 1.5 percent) who took Truvada, a daily pill that has been available for more than a decade, and 39 of 2,136 women (1.8 percent) who received a newer daily pill called Descovy were infected.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