Drugs (Pharmaceuticals)

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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

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

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      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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      2026 Prices for Drugs That Are Subject to Negotiations

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      The prices were made possible by the Inflation Reduction Act, which granted the health secretary the authority to negotiate on behalf of Medicare.The Biden administration on Thursday announced the results of negotiations between Medicare and pharmaceutical companies over the prices of 10 costly or common medications. The new prices, which will take effect in 2026, are the maximum Medicare Part D plans and patients will pay for a one-month supply.1. Eliquis, for preventing strokes and blood clots, from Bristol Myers Squibb and Pfizer, $2312. Jardiance, for diabetes and heart failure, from Boehringer Ingelheim and Eli Lilly, $1973. Xarelto, for preventing strokes and blood clots, from Johnson & Johnson, $1974. Januvia, for diabetes, from Merck, $1135. Farxiga, for diabetes, heart failure and chronic kidney disease, from AstraZeneca $1786. Entresto, for heart failure, from Novartis, $2957. Enbrel, for autoimmune conditions, from Amgen, $2,3558. Imbruvica, for blood cancers, from AbbVie and Johnson & Johnson, $9,3199. Stelara, for autoimmune conditions, from Johnson & Johnson, $4,69510. Fiasp and NovoLog insulin products, for diabetes, from Novo Nordisk, $119 More

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      FDA Declines to Approve MDMA Therapy, and Seeks Further Study

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      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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      Compounded Semaglutide: What to Know About Overdose Risks of Ozempic Alternative

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      Some patients say it’s easy to get the do-it-yourself doses of compounded semaglutide wrong.Three hours after Becky Cheairs injected herself with the first dose of compounded semaglutide, she started to vomit. Crouched over the toilet, reeling from nausea, she thought there was no way she would make it on the R.V. trip from Arkansas to San Antonio she had planned that weekend.She was right: She spent the next day throwing up at least once an hour.Like many others, Ms. Cheairs, 66, had taken the drug to lose weight. But she hadn’t taken the brand-name products Ozempic or Wegovy, which come in pens pre-filled with a specific dose. Instead, the medication she was prescribed through a telehealth service came with a vial and a bag of syringes to draw the drug out herself.Ms. Cheairs’ husband asked how much she had taken, then read the instructions. He was shocked: Ms. Cheairs had accidentally given herself five times the amount she was supposed to take.Accidents like this are becoming more common. There have been 159 calls to national poison control centers so far this year involving compounded GLP-1s, the class of medications that includes semaglutide. In 2023, there were only 32.The vast majority of these calls are from people who took too much medication, said Kait Brown, the clinical managing director at America’s Poison Centers. The problem has become so concerning that the Food and Drug Administration issued a warning last month about people overdosing on compounded semaglutide. Some patients have been hospitalized, developed pancreatitis or gallstones, or have fainted or become dehydrated. Some patients had taken 10 or even 20 times more than the intended dose.The demand for Ozempic and similar drugs has pushed compounded medications, once a somewhat niche corner of health care, into the mainstream. There isn’t solid data on how many people take compounded GLP-1s. But some estimates have suggested millions of Americans may be seeking them out, often, because they are looking for a cheaper option or can’t find the brand-name drug in stock.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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      Antisemitism on Campuses, Ivy and Beyond

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      More from our inbox:A Middleman’s Role in Drug PrescriptionsObjection, Your HonorTrump vs. the Environment Alex Welsh for The New York TimesTo the Editor:Re “Should American Jews Abandon Elite Universities?,” by Bret Stephens (column, June 26):Mr. Stephens has issued a sobering and well-documented indictment of antisemitism on elite campuses. The question asked by the headline is timely and troubling for many Jewish high school students and their families.As noted by Mr. Stephens, confused administrators and revisionist curriculums contributed to this crisis. But the insensitivity and hypocrisy of supposedly idealistic and enlightened college students may be the most striking and unkind cut of all.“Safe spaces” and rules against “microaggressions” have become commonplace on campuses. Yet when Jewish students made it known that calling for deadly attacks on Jews (“Globalize the intifada!”) is offensive and intimidating, they were ignored.Chants in favor of colonization or racism would never — and should never — be met with such indifference. It hurts.Perhaps the headline of Mr. Stephens’s column should be rephrased: “Have Elite Universities Abandoned American Jews?”Alan M. SchwartzTeaneck, N.J.To the Editor:While the Ivies have claimed the antisemitism spotlight this year, Jew-hatred is flourishing on many other campuses, including mine, the University of California, Davis.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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      Fake Ozempic Is Putting Patients at Risk. Here’s How to Spot It.

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      Fake versions of popular drugs used for weight loss are putting people at risk.Experts have grown increasingly concerned about fake versions of Ozempic and popular weight loss drugs. These copycats can look deceptively real, and may contain dangerous substances or entirely different drugs altogether.In June, the World Health Organization warned that fake batches of Ozempic were found in the United States, the United Kingdom and Brazil. Also in June, Eli Lilly issued a letter expressing concern that counterfeit versions of its own drugs, Mounjaro and Zepbound, were being sold online, through social media and at medical spas. Those who study the counterfeit drug market say these findings are alarming, but not all that surprising. The drugs are expensive, often hard to find and highly sought-after.“Such high demand and short supply and such a desperate population — that’s a recipe for disaster,” said George Karavetsos, a former director of the Food and Drug Administration’s Office of Criminal Investigations.As a result, a counterfeit market has emerged, with phony drugs sold online at low prices without a prescription or any contact with a doctor. Some websites have storefronts to sell what they claim is semaglutide, the substance in Ozempic, which customers can add straight into an online shopping cart. The National Association of Boards of Pharmacy said it had identified thousands of websites illegally selling drugs like Ozempic, including fake versions. Patients often have no way to verify what’s in these products.Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines, said he worried about both the rise of fake drugs and also the popularity of compounded semaglutide and tirzepatide, the substance in Mounjaro. These customized versions of drugs are made at compounding pharmacies and under best practices, contain ingredients that come from facilities registered with the F.D.A. But regulators have warned about adverse events linked to compounded semaglutide, and stressed that compounded medications are subject to less oversight than traditionally approved medications.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