Clinical Trials

Subterms

    Latest story

    100 Shares140 Views

    Heart-Valve Patients Should Have Earlier Surgery, Study Suggests

    by

    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

    More stories

    • 138 Shares169 Views

      in Elections

      Francisco Lopera, the ‘Country Doctor’ Who Upended Our Understanding of Dementia

      by

      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

    • 100 Shares99 Views

      in Elections

      Three MDMA Studies Are Retracted by Scientific Journal

      by

      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

    • 125 Shares99 Views

      in Elections

      FDA Declines to Approve MDMA Therapy, and Seeks Further Study

      by

      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

    • 150 Shares169 Views

      in Elections

      A Blood Test Accurately Diagnosed Alzheimer’s 90% of the Time, Study Finds

      by

      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

    • 163 Shares199 Views

      in Elections

      Gilead Shot Provides Total Protection From HIV in Trial of Young African Women

      by

      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

    • 113 Shares189 Views

      in Elections

      Ozempic and Wegovy Have Health Benefits Beyond Weight Loss

      by

      Last year was called the year of Ozempic, though it was also a year of Ozempic backlash and Ozempic shortages, which could persist for years. Even so, we appear very far from a peak for GLP-1 drugs, like Ozempic and Wegovy, which are powered by a molecule called semaglutide, and Mounjaro, which uses its cousin tirzepatide. It seems possible to imagine a future in which almost everyone is taking some variety of GLP-1 drug, and with a pretty good reason to do so.Probably, you have heard about the game-changing impact of such drugs on obesity, a condition that affects 40 percent of Americans and increases the risk of heart disease, stroke and hundreds of other comorbidities. Patients on Ozempic and Wegovy can lose 15 to 20 percent or more of their weight in a little over a year, and if they stay on the drugs, the weight tends to stay off. That may not sound like a monumental effect, but consider that on average, an obese 210-pound man who loses 20 percent of his body mass generally passes quickly through the overweight stage all the way to a normal weight.If anything, though, we’ve probably talked too much about cosmetic weight loss and Hollywood vanity — and certainly made too many comparisons to fen-phen, Botox and Viagra. The GLP-1 drugs have been shown to cut risk of heart attacks, strokes and death from coronary disease by 20 percent among overweight and obese patients, presumably through the salubrious effect of weight loss, though the researchers can’t yet say for sure. Semaglutide has been shown to eliminate or reduce the need for insulin among those with recent-onset Type 1 diabetes. In a clinical trial of people with Type 2 diabetes and moderate to severe kidney disease, the drug reduced the risk of kidney disease progression and cut the death rate from cardiovascular and kidney-related causes by 24 percent — such a clear result that the trial was ended early. Semaglutide has reduced fatty liver deposits in patients with H.I.V. and nonalcoholic steatotic liver disease. It has normalized the menstrual cycles of those with polycystic ovary syndrome. (It has also, somewhat mysteriously, seemed to produce a wave of unintended pregnancies among women taking birth control, at least if TikTok videos are to be trusted.)Studies have shown promise in treating Alzheimer’s and Parkinson’s with GLP-1 drugs, perhaps by regulating insulin levels and reducing inflammation, and the drugs may yet prove useful in treating many other conditions made worse by chronic inflammation. Some studies have found large decreases in the risk of depression and anxiety; others found smaller but still positive effects. There are potential applications for schizophrenia and neurological dysfunction, thanks to the role that insulinlike hormones like GLP-1 play in the development of the central nervous system and the way semaglutide reshapes the brain’s chemical reward system. It seems to bend the curve on alcoholism and drug addiction and curb other addictive behaviors, as well — compulsive shopping and sex addiction, gambling and nail biting, smoking and skin picking. A compulsive nation has stumbled into what looks like a treatment for compulsion and one that happens to protect against some of the country’s biggest killers and curb some of its most pervasive pathologies and inner demons.Americans love to dream of miracle drugs, but hardly anything ever seems to fill the bill. True, semaglutide has arrived with real questions trailing like bunting: Much of the weight loss is from lean muscle mass, which isn’t ideal, and there are reasons to worry over the possibility of thyroid problems, loss of bone density and sarcopenia, a weakness disorder associated with aging. There are potentially other serious long-term side effects, though millions of Americans have been taking Ozempic for Type 2 diabetes for years without serious issues. (Some of them do report more familiar side effects, like nausea.) The GLP-1 drugs aren’t a permanent fix in a single shot — whether the thing being addressed is body mass index or cardiac risk or the progression of Alzheimer’s — but a permanent disease-management program. They also haven’t exactly cured cancer, although more than a dozen cancers are linked to obesity, and in at least one case, colorectal cancer, there is reason to believe GLP-1 drugs may directly cut the chances of developing the disease.All that means that semaglutide isn’t exactly a cure-all, in the vernacular sense. But it seems to be about as close as we’ve gotten, even in a time of racing biomedical progress, to that old science-fiction proposition — one pill for almost everything and almost everyone forever.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

    • 100 Shares129 Views

      in Elections

      Could Long Covid Be the Senate’s Bipartisan Cause?

      by

      Senator Roger Marshall’s voice was shaking with emotion as he made the case for speedy and focused research into long Covid. Marshall, the junior senator from Kansas, is a Republican and a medical doctor. But addressing the first-ever Senate hearing on long Covid last month, he wanted the audience to know that his interest wasn’t just professional and it definitely wasn’t just political. It was also personal.One of his loved ones, he explained, suffered from severe long Covid. “We’ve taken my loved one to dozens of doctors,” he said. “I’ve talked to 40, 50, 60, 80. I’ve read everything there is to read about long Covid, talked to other members of the Senate that have had long Covid. What are they doing? So I share your frustration.”It was personal for many in the audience, as well. Four years after the Covid pandemic began, leaving millions of people suffering from long-term health effects, the hearing had been announced with about a week’s notice — a scramble for people who were ill and, in many cases, in dire financial straits. But somehow the room was overflowing.Many in attendance told me they were worried that the political polarization around everything pandemic-related would thwart even belated progress on this important issue. I came away with a very different view.Bernie Sanders, the chair of the Senate Health, Education, Labor and Pensions Committee, kicked off the hearings by making an impassioned plea on behalf of the patients. He said the medical establishment had been too dismissive of their plight, and he conceded that Congress had not done nearly enough to help.But it was Marshall who spoke with precision about the scientific literature. He rattled off the leading theories about why some people with long Covid are debilitated and described specific symptoms in detail.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