Results of a large clinical trial found the treatment did not work any better than a placebo.The maker of the newest treatment approved for amyotrophic lateral sclerosis said Thursday that it would withdraw the drug from the market because a large clinical trial did not produce evidence that the treatment worked.The company, Amylyx Pharmaceuticals, said in a statement that it had started the process of withdrawing the drug in the United States, where it is called Relyvrio, and in Canada, where it is called Albrioza. As of Thursday, no new patients will be able to start the drug, while current patients who wish to continue taking the medication can be transitioned to a free drug program, the company said.The medication is one of only a few treatments for the severe neurological disorder. When the Food and Drug Administration approved it in September 2022, the agency concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the progression of the disease.It decided to greenlight the medication anyway, instead of waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of A.L.S. patients. The disease robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years.Since then, about 4,000 patients in the United States have received the treatment, a powder that is mixed with water and either drunk or ingested through a feeding tube. Its list price was $158,000 a year.Last month, Amylyx, of Cambridge, Mass., announced that the results of a 48-week trial of 664 patients showed that the treatment did not work better than a placebo. The company said then that it would consider withdrawing the drug from the market.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.

A majority of the Supreme Court seemed inclined on Tuesday to reject a bid to sharply limit access to abortion pills.During about 90 minutes of argument, most of the justices seemed doubtful that the plaintiffs, who do not prescribe abortion pills or regularly treat abortion patients, even had standing to bring the challenge. The justices, including several in the conservative majority, questioned whether the plaintiffs could show that they faced the moral harm they claimed to suffer from the availability of the pill, mifepristone.The case centers on whether changes the Food and Drug Administration made in 2016 and 2021, which broadened access to the drug, would have to be rolled back.Those changes made it possible for patients to obtain prescriptions for mifepristone by telemedicine and receive abortion pills in the mail, which has greatly increased the availability of medication abortion.Several justices questioned the remedy the plaintiffs seek: to apply nationwide restrictions to the drug in a case that would have very broad implications because it would be the first time a court had second-guessed the F.D.A.’s regulatory authority.“This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an F.D.A. rule or any other federal government action,” said Justice Neil Gorsuch, an appointee of President Donald J. Trump.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.

The NewsOn the eve of oral arguments in a Supreme Court case that could affect future access to abortion pills, new research shows the fast-growing use of medication abortion nationally and the many ways women have obtained access to the method since Roe v. Wade was overturned in June 2022.The DetailsPackages of abortion pills being prepared to send to patients.Sophie Park for The New York TimesA study, published on Monday in the medical journal JAMA, found that the number of abortions using pills obtained outside the formal health system soared in the six months after the national right to abortion was overturned. Another report, published last week by the Guttmacher Institute, a research organization that supports abortion rights, found that medication abortions now account for nearly two-thirds of all abortions provided by the country’s formal health system, which includes clinics and telemedicine abortion services.The JAMA study evaluated data from overseas telemedicine organizations, online vendors and networks of community volunteers that generally obtain pills from outside the United States. Before Roe was overturned, these avenues provided abortion pills to about 1,400 women per month, but in the six months afterward, the average jumped to 5,900 per month, the study reported.Overall, the study found that while abortions in the formal health care system declined by about 32,000 from July through December 2022, much of that decline was offset by about 26,000 medication abortions from pills provided by sources outside the formal health system.“We see what we see elsewhere in the world in the U.S. — that when anti-abortion laws go into effect, oftentimes outside of the formal health care setting is where people look, and the locus of care gets shifted,” said Dr. Abigail Aiken, who is an associate professor at the University of Texas at Austin and the lead author of the JAMA study. The co-authors were a statistics professor at the university; the founder of Aid Access, a Europe-based organization that helped pioneer telemedicine abortion in the United States; and a leader of Plan C, an organization that provides consumers with information about medication abortion. Before publication, the study went through the rigorous peer review process required by a major medical journal.The telemedicine organizations in the study evaluated prospective patients using written medical questionnaires, issued prescriptions from doctors who were typically in Europe and had pills shipped from pharmacies in India, generally charging about $100. Community networks typically asked for some information about the pregnancy and either delivered or mailed pills with detailed instructions, often for free.Online vendors, which supplied a small percentage of the pills in the study and charged between $39 and $470, generally did not ask for women’s medical history and shipped the pills with the least detailed instructions. Vendors in the study were vetted by Plan C and found to be providing genuine abortion pills, Dr. Aiken said.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.

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Leaders of the treatment’s manufacturer, Amylyx, said they would announce their plans for it within eight weeks.One of the few treatments the Food and Drug Administration has approved for amyotrophic lateral sclerosis has failed a large clinical trial, and its manufacturer said Friday that it was considering whether to withdraw it from the market.The medication, called Relyvrio, was approved less than two years ago, despite questions about its effectiveness in treating the severe neurological disorder. At the time, the F.D.A.’s reviewers had concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.But the agency decided to greenlight the medication instead of waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of patients with a disease that often causes death within two to five years. Since then, about 4,000 patients in the United States have received the treatment, a powder that is mixed with water and either drunk or ingested through a feeding tube and carries a list price of $158,000 a year.Now, results of the 48-week trial of 664 patients are in, and they showed that the treatment did not work better than a placebo.“We are surprised and deeply disappointed,” Justin Klee and Joshua Cohen, the co-chief executive officers of Amylyx Pharmaceuticals, the treatment’s manufacturer, said in a statement. They said they would announce their plans for the medication within eight weeks, “which may include voluntarily withdrawing” it from the market.“We will be led in our decisions by two key principles: doing what is right for people living with A.LS., informed by regulatory authorities and the A.L.S. community, and by what the science tells us,” Mr. Klee and Mr. Cohen said.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.

Eli Lilly’s donanemab was expected to be approved this month, but the agency has decided to convene a panel of independent experts to evaluate the drug’s safety and efficacy.The Food and Drug Administration has decided to delay action on a closely watched Alzheimer’s drug, donanemab, which the agency was widely expected to approve this month. The F.D.A. will instead require donanemab to undergo the scrutiny of a panel of independent experts, the drug’s maker, Eli Lilly and Company, said Friday.“The F.D.A. has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design,” the company said in a statement.The decision is likely to surprise many Alzheimer’s experts, doctors and patients who had expected the medication would soon be on the market. The F.D.A.’s move was startling to the company, which had been planning for the agency to greenlight the drug during the first quarter of this year.“We were not expecting this,” Anne White, an executive vice president of Lilly and president of its neuroscience division, said in an interview. She said that while the F.D.A. often calls on such independent advisory committees when it has questions about drugs, it was unusual to do so “at the end of the review cycle and beyond the action date that the F.D.A. had given us.”The F.D.A. did not say anything publicly about the move, which will delay any decision about whether to approve donanemab until at least later this year. Lilly officials said they expected it would be a few months before the advisory committee holds a hearing.“The F.D.A. did commit to us to move quickly, so we would hope that they would then take action shortly after the advisory committee,” Mrs. White said.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.

The NewsThe first nonprescription birth control pill in the United States will be available in stores and online in the coming weeks at a price of $19.99 a month, the manufacturer, Perrigo Company, announced on Monday.Perrigo Company, via Associated PressWhy It MattersThe medication, called Opill, which was approved for over-the-counter sale by the Food and Drug Administration last year, will be the most effective birth control method available without a prescription, research shows — more effective than condoms, spermicides and other nonprescription methods.Reproductive health experts said that its availability could be especially useful for teenagers, young women, and others who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription.Some experts said they thought it might be a particularly good option for teenagers, who might otherwise rely on condoms.Lupe M. Rodriguez, the executive director of the National Latina Institute for Reproductive Justice, said in a statement Monday that “over-the-counter access to birth control will greatly reduce the barriers like transportation, cost, language, and documentation.”Opill is not a new medication — it was approved for prescription use 50 years ago. Reproductive health experts and members of an F.D.A. advisory panel cited its long history of safety and efficacy. It is 93 percent effective at preventing pregnancy with typical use. Women with certain conditions — primarily breast cancer or undiagnosed vaginal bleeding — should not take Opill. But for most women, “the risk is very low, and almost nonexistent if they read and follow the labeling,” Karen Murry, the deputy director of the F.D.A.’s office of nonprescription drugs, said in a memo explaining the approval decision.Since the Supreme Court overturned the national right to an abortion in 2022, the accessibility of contraception has become an increasingly urgent issue. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups.The approval of Opill faced very little public opposition from conservative groups that are often critical of measures that increase access to abortion, emergency contraception and sex education. Opposition appeared to come primarily from some Catholic organizations and Students for Life Action.In a survey in 2022 by the health care research organization KFF, more than three-quarters of women of reproductive age said they favored an over-the-counter pill, primarily because of convenience.The DetailsWe 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.

The pill mifepristone will be available with a prescription at pharmacy counters in a few states to start.The two largest pharmacy chains in the United States will start dispensing the abortion pill mifepristone this month, a step that could make access easier for some patients.Officials at CVS and Walgreens said in interviews on Friday that they had received certification to dispense mifepristone under guidelines that the Food and Drug Administration issued last year. The chains plan to make the medication available in stores in a handful of states at first. They will not be providing the medication by mail. Both chains said they would gradually expand to all other states where abortion was legal and where pharmacies were legally able to dispense abortion pills — about half of the states.Walgreens will start providing the pill within the next week in a small number of its pharmacies in New York, Pennsylvania, Massachusetts, California and Illinois, said Fraser Engerman, a spokesman for the chain. “We are beginning a phased rollout in select locations to allow us to ensure quality, safety and privacy for our patients, providers and team members,” he said.CVS will begin dispensing in all of its pharmacies in Massachusetts and Rhode Island “in the weeks ahead,” Amy Thibault, a spokeswoman for the company, said.The chains will be monitoring the prospects in a few states, including Kansas, Montana and Wyoming, where abortion bans or strict limitations have been enacted but are enjoined because of legal challenges.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.

People with long Covid symptoms scored slightly lower on a cognitive test than people who had recovered. But patients who had recovered scored as well as those who had only short-term Covid symptoms.Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new study suggests.Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.“These emerging and coalescing findings are generally highlighting that yes, there is cognitive impairment in long Covid survivors — it’s a real phenomenon,” said James C. Jackson, a neuropsychologist at Vanderbilt Medical Center, who was not involved in the study.He and other experts noted that the results were consistent with smaller studies that have found signals of cognitive impairment.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.

Doctors in six states where abortion is legal are using new laws to send abortion pills to tens of thousands of women in states where it is illegal.Behind an unmarked door in a boxy brick building outside Boston, a quiet rebellion is taking place. Here, in a 7-by-12-foot room, abortion is being made available to thousands of women in states where it is illegal.The patients do not have to travel here to terminate their pregnancies, and they do not have to wait weeks to receive abortion medication from overseas.Instead, they are obtaining abortion pills prescribed by licensed Massachusetts providers, packaged in the little room and mailed from a nearby post office, arriving days later in Texas, Missouri and other states where abortion is largely outlawed.This service and others like it are operating under novel laws enacted in a half-dozen states — Massachusetts, Washington, Colorado, Vermont, New York and California — that have sought to preserve abortion access since the Supreme Court overturned the nationwide right to abortion in June 2022. The laws have been in use only since the summer and have not been tested in the courts, but they are already providing abortion access to tens of thousands of women in states with bans, especially low-income patients and others who cannot travel.Called telemedicine abortion shield laws, they promise to protect doctors, nurse practitioners and midwives licensed in those six states who prescribe and send abortion pills to patients in the nearly two dozen states that ban or sharply restrict abortion.The laws stipulate that officials and agencies of their states will not cooperate with another state’s efforts to investigate or penalize such providers — a stark departure from typical interstate practices of extraditing, honoring subpoenas and sharing information, legal experts on both sides of the abortion issue say. Many expect them to ultimately be challenged in federal court. 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.