When the idea struck him, nearly 50 years ago, Dr. Étienne-Émile Baulieu believed it could be revolutionary. Creating a pill that could abort a pregnancy would transform reproductive health care, he thought, allowing women to avoid surgery, act earlier and carry out their decisions in private.“When science meets women’s cause, it is irresistible,” Dr. Baulieu, 96, a French endocrinologist and biochemist often called the father of the abortion pill, said on a recent Sunday afternoon in his apartment in a century-old building a short walk from the Eiffel Tower.He had also hoped, as he wrote in a 1990 book, that by the 21st century, “paradoxically, the ‘abortion pill’ might even help eliminate abortion as an issue.”That prospect seems as distant as ever, especially in the United States. Not only has abortion remained fiercely contentious since the pill Dr. Baulieu spearheaded, mifepristone, was approved in America in 2000, but last year’s Supreme Court decision ending the federal right to abortion has divided the country over the issue as never before.Yet over time, some of Dr. Baulieu’s other expectations have materialized. Today, medication abortion, in which mifepristone and a second drug are taken early in pregnancy, is used in over half of pregnancy terminations in the United States. That proportion is expected to increase, even in states that have banned abortion, where growing use has put the pills at the center of legal and political battles.For Dr. Baulieu, who continues work in his lab on the southern rim of Paris, his office overlooking a former asylum where the Marquis de Sade was held, the volatile developments are just the latest turns in an eventful life. He transported guns as a teenager in the French Resistance during World War II, changing his name and taking refuge high in the Alps. He joined the Communist Party and then quit it in 1956 after the Soviet invasion of Hungary. And he socialized with the artists Andy Warhol and Jasper Johns in the 1960s, beginning a pattern of friendships with painters, sculptors, musicians and actors that he said had helped inspire his scientific work.Dr. Baulieu continues to work at his lab at the Kremlin-Bicêtre Hospital on the southern edge of Paris. Julie Glassberg for The New York TimesMifepristone, typically followed by misoprostol, is now used in more than half of U.S. pregnancy terminations.Gabriela Bhaskar for The New York TimesThat work has earned Dr. Baulieu many scientific honors, including the Lasker Award, often considered the most prestigious American prize in medicine. Recently, France’s president, Emmanuel Macron, awarded him the Grand Cross of the Legion of Honor, the highest distinction. Admirers have floated his name for a Nobel Prize.For his leading role in developing mifepristone, he has been hailed as a visionary by abortion rights supporters and vilified as an incarnation of Hitler by abortion opponents, a charge that he said he found especially jarring because he is Jewish.Although he and the pill have become lightning rods, Dr. Baulieu speaks of the abortion debate without vitriol, cognizant of the complexity of the issue.“When he believes something, he’s quite relaxed,” said Simone Harari Baulieu, who has been his romantic partner for over 25 years and became his second wife in 2016.With a medical degree and a Ph.D. in biochemistry, Dr. Baulieu has always considered himself “a doctor who practices science,” looking for ways to translate research into useful applications.Scientifically and medically, “women are not enough understood,” he said, adding: “I like women. Why not?”An independent streakDr. Baulieu’s office is jumbled with memorabilia, papers, books, art and a chalkboard with sketches of how the brain processes memories.Julie Glassberg for The New York TimesEclectic artifacts fill the home Dr. Baulieu shares with his wife, who runs a film and television production company.In a portrait by the photographer Richard Avedon, Dr. Baulieu wears a black turtleneck and holds a small white pill. A surrealist painting of him and Ms. Harari Baulieu by the contemporary French artist Gérard Garouste hangs above an ornate fireplace.Shelves overflow with books: Maimonides’s “The Guide for the Perplexed”; a history of “Old Shanghai”; a collection of excerpts from Proust. More books are piled on the living room’s parquet wood floor, near windows overlooking a narrow balcony edged by an ornamental iron railing.On the dining room table are two recent gifts from Vice President Kamala Harris. Her late mother, Shyamala Gopalan Harris, a breast cancer researcher, spent about a year working in Dr. Baulieu’s lab in the 1980s, collaborating with him on research about estrogen and a mammary gland protein. (She did not work on the abortion drug.)On an official trip to France in 2021, the vice president met privately with Dr. Baulieu and his wife. She gave them a glass bowl and the French translation of her book, inscribed: “Thank you for your friendship and all you do and mean to our family. Love, Kamala.” Last month, in remarks at a luncheon for Mr. Macron in Washington, Ms. Harris mentioned her mother’s work with “the legendary French Professor Baulieu.”Dr. Baulieu’s instinct for innovation may have come from his father, Dr. Léon Blum, a kidney specialist who was one of the first doctors to use insulin for diabetics and who treated an Egyptian king’s diabetes while on his honeymoon with Dr. Baulieu’s mother.In World War I, Dr. Blum, who was from German-occupied Alsace, was drafted by the German Army. But he surreptitiously aided France by asking German officers he treated to mail him postcards about how much urine they were producing; he used the postmarks to gauge German troop movements and gave that intelligence to the French military. Eventually, he fled to France, where he was awarded the Legion of Honor.He died at age 54 when his son, born Étienne Blum, was only 3. Étienne’s mother, Thérèse Lion, a lawyer and conservatory-trained pianist, moved her three children to Paris.“She believed that my father died because of contamination from sick people,” Dr. Baulieu said. She told him he could become anything he wanted, except a doctor. “And the only thing I chose was to become a physician,” he said.Photos in Dr. Baulieu’s office show him with his father, left, Léon Blum, a kidney specialist, and his mother, Thérèse Lion, a lawyer and pianist.Julie Glassberg for The New York TimesMax-Fernand Jayle, who studied hormonal processes in women, was a mentor to Dr. Baulieu and gave him opportunities early in his career.Julie Glassberg for The New York TimesHis independent streak was honed long before that, though. During World War II, his family fled German-occupied Paris for Grenoble, and at 15, he and classmates distributed anti-Nazi leaflets and “threw stones at people who were working for Germans,” he said.Two years later, he was in a cafe when he noticed men lurking outside and realized, “I was detected by the Germans.” He slipped out the back and left town without saying goodbye to his mother.When he joined French Resistance members in the alpine towns of Chamonix and Annecy, they suggested he change his name, offering several options, including “Beaulieu,” which means “beautiful place.” He liked that, but felt it would be pretentious to adopt “beautiful” as a name, so he changed the spelling to “Baulieu” and chose “Émile” as a first name.His group’s activities included ferrying arms and kidnapping and executing an imprisoned Vichy official.“I was too young to shoot,” Dr. Baulieu said, “so they gave me a camera,” which he used to photograph the execution.“I hated the violence, but they were really enemies and traitors,” he said.Like fellow French Resistance members, he joined the Communist Party but declined to become a party official after the war. Instead, he went to medical school.He joined the lab of a scientist, Max-Fernand Jayle, who had been blinded during an experiment. Dr. Baulieu said other students thought working for Dr. Jayle would be a career dead end, but he considered Dr. Jayle inspiring and original.An encouraging mentor, Dr. Jayle, who studied hormonal processes in women, gave Dr. Baulieu advanced opportunities that allowed him to become a tenured professor at 31.In an important early discovery that had eluded many scientists, Dr. Baulieu determined how to detect a hormone, dehydroepiandrosterone, or DHEA, which helps produce estrogen and testosterone and can signal diseases like adrenal cancer.“I did it with a simple idea which, in classical terms, made little sense,” he wrote. Instead of looking in oily extracts from the adrenal glands, he found a water-soluble form in urine, “like probing a vinaigrette: looking in the vinegar instead of the oil.”Vice President Kamala Harris gave Dr. Baulieu a bowl emblazoned with the vice presidential seal. Her mother, Shyamala Gopalan Harris, a breast cancer researcher, spent about a year working in Dr. Baulieu’s lab in the 1980s.Pam Belluck/The New York TimesA sculpture, called “Nana,” with parts by Niki de Saint Phalle, left, and Jean Tinguely, right, in Dr. Baulieu’s office.Julie Glassberg for The New York TimesThat earned him an invitation to spend a year at Columbia University with Dr. Seymour Lieberman, a steroid expert. But Dr. Baulieu’s previous Communist ties led the Eisenhower administration to repeatedly reject his visa application, despite pleas from fellow scientists, and he obtained a visa only after John F. Kennedy became president.On the ship to New York in 1961, Dr. Baulieu met Barbara Rose, a prominent art historian. She introduced him to up-and-coming artists, including Frank Stella (whom she later married), Mr. Johns, Mr. Warhol and Robert Rauschenberg.“I realized from my artist friends the similarity of creation in science and art,” Dr. Baulieu wrote.His admiration for creative people endured, leading to close friendships and occasional romances. During his long marriage to his first wife, with whom he had three children, he had several romantic relationships, he said, adding, “I knew a number of beautiful, interesting, intelligent and free women.”One relationship was with Niki de Saint Phalle, whose riotously colorful paintings and sculpture are displayed in his home and laboratory office. In the late 1970s, at the French Riviera home of the conductor Herbert von Karajan, Dr. Baulieu met the actress Sophia Loren, and he said they had a romantic relationship while both were married to other people. At one point, they were photographed in a car. “I was in love, yes,” Dr. Baulieu said. The relationship ended, he said, because she was devoted to raising her children and wanted to preserve her marriage. A representative for Ms. Loren declined to respond to questions. In 1991, Ms. Loren told Vanity Fair, “I was never involved with him.”An ‘unpregnancy pill’Dr. Baulieu in 1984, holding an abortion pill.Arnaud Borrel/Gamma-Rapho, via Getty ImagesDr. Baulieu’s path to developing the abortion pill began in 1961 with a speaking invitation from Gregory Pincus, who helped invent the birth control pill. Dr. Pincus, then a co-director of the Worcester Foundation for Experimental Biology in Massachusetts, became another mentor. He suggested that Dr. Baulieu travel to Puerto Rico to observe clinical trials of the contraceptive pill.“When I saw what they were doing in Puerto Rico, it was remarkable for the treatment of women,” Dr. Baulieu said.Back in Paris, Dr. Baulieu, who directed a unit at France’s National Institute of Health and Medical Research, rejected an offer to become head of research at the pharmaceutical company Roussel-Uclaf, but agreed to become a part-time consultant. The arrangement allowed him to use some company laboratories and molecules for research but barred him from earning money from any Roussel-Uclaf products.He began thinking of potential advances in reproductive medicine. During his medical residency, he’d learned that some women seeking to terminate pregnancies would insert sticks to cause miscarriages and would then go to the hospital. He was shocked that some surgeons instructed employees not to give anesthesia. “‘Teach her a lesson she’ll remember,’ I heard one of them say,” he wrote.In 1970, Dr. Baulieu was visiting India with a group of intellectuals when a woman begging on a bridge in Kolkata, then known as Calcutta, approached him while cradling her dead baby and holding the hand of a child who held another one of her children.“It really caused an emotion for me, which has persisted all my life,” he said. “I think always of Calcutta as something which has pushed me to really work hard.”He started brainstorming an idea for an “unpregnancy pill.” It would involve a kind of biological sleight-of-hand.The lab at Kremlin-Bicêtre Hospital.Julie Glassberg for The New York TimesDr. Baulieu described the work of RU-486 as “contragestion” because it counteracted the gestation process. More simply, he wrote, “RU-486’s action is like jamming a radio signal.”Julie Glassberg for The New York TimesThe hormone progesterone is pivotal in pregnancy because it prepares the uterus to receive and hold an embryo. What if progesterone could be prevented from delivering its cellular messages?“I wanted to create an anti-hormone,” Dr. Baulieu said.In guinea pigs, his team identified receptor molecules that progesterone connected with to convey messages. Dr. Baulieu suggested trying to make a faux progesterone, an impostor to latch onto progesterone receptors so the real hormone could not.He asked Roussel-Uclaf’s chemists to try grafting a cluster of atoms onto a molecule with progesterone’s structure so it would be similar enough to bind to the progesterone receptor.The leader of the German company that was Roussel-Uclaf’s majority stakeholder, Hoechst AG, was a staunchly anti-abortion Catholic, Wolfgang Hilger. To avoid controversy in meetings with company officials, Dr. Baulieu said, he emphasized a non-abortion-related property of an antiprogesterone compound: Because it would also block receptors for the stress hormone cortisol, it could theoretically treat burns, wounds, glaucoma and other conditions.In 1980, Roussel-Uclaf’s chief chemist, Georges Teutsch, synthesized a compound that worked as Dr. Baulieu had envisioned.“Although neither Teutsch nor most of the others in the company initially realized it, it was also what I wanted: an antiprogesterone,” Dr. Baulieu wrote. Registered as Roussel-Uclaf 38486, the company’s 38,486th molecule, it was nicknamed RU-486.“It’s like a key in a lock,” Yvette Akwa, a researcher in Dr. Baulieu’s lab, explained recently. “You make a similar key that fits the lock. And then when progesterone would go to open the door, it can’t because it’s already blocked.”Dr. Baulieu called the concept “contragestion” because it counteracted the gestation process. More simply, he wrote, “RU-486’s action is like jamming a radio signal.”After other scientists tested RU-486 on rats and monkeys, Dr. Baulieu urged Roussel-Uclaf to allow human trials and asked an obstetrician-gynecologist friend in Switzerland, Dr. Walter Herrmann, to conduct them. In 1982, a trial found that RU-486 aborted early pregnancies in nine of 11 patients. Later trials showed that by following RU-486 with a prostaglandin, a medication that causes contractions, the method was about 95 percent effective. Today, RU-486 — mifepristone — is followed 24 to 48 hours later by a synthetic prostaglandin called misoprostol.A demonstration against RU-486 outside the headquarters of Roussel-Uclaf in Paris in 1991.Jean-Michel Turpin/Gamma-Rapho, via Getty Images“Up to then, abortion had not been proposed in a way which, at the same time, is efficient, safe and not too difficult for women,” Dr. Baulieu said.Abortion opponents pilloried the company, swarming a shareholders’ meeting. Drawing analogies to Hoechst’s predecessor company, I.G. Farben, which made the cyanide gas used in Nazi death camps, some shouted, “You are turning the uterus into a crematory oven,” Dr. Baulieu wrote.In Washington, an anti-abortion campaign flooded the French Embassy with letters threatening to boycott French products if France approved the pill. The company almost withdrew its application. In September 1988, the French authorities approved RU-486.Several days later, debating Dr. Baulieu on French television, Dr. Jérôme Lejeune, an anti-abortion pediatrician who discovered the genetic basis of Down syndrome, called RU-486 “the first anti-human pesticide” and said it would “kill more human beings than Hitler, Mao Zedong and Stalin combined.”“You can’t say it’s like Hitler,” Dr. Baulieu exclaimed. “Don’t say things that would make me laugh if this weren’t a serious debate.”The clamor from opponents was so intense that a month after the approval, Roussel-Uclaf said it would stop marketing RU-486. Dr. Baulieu wrote that the company’s chairman, Dr. Edouard Sakiz, told him that he feared a violent incident, like one that month when an ultraconservative group set fire to a Paris movie theater showing “The Last Temptation of Christ.”But Dr. Sakiz told Dr. Baulieu he was free to speak out. Dr. Baulieu flew to Brazil for the World Congress of Gynecology and Obstetrics, where doctors and researchers vehemently decried Roussel-Uclaf’s withdrawal of RU-486.Soon afterward, Claude Évin, the health minister of France, which owned part of Roussel-Uclaf, called RU-486 “the moral property of women” and pressured the company to resume selling it. “I could not permit the abortion debate to deprive women of a product that represents medical progress,” he said.A poster advertised a conference Dr. Baulieu spoke at in China in the 1990s.Julie Glassberg for The New York TimesDr. Baulieu in his uniform from the French Academy of Sciences.via Étienne-Émile BaulieuAfter RU-486’s approval, Dr. Elisabeth Aubény, an obstetrician-gynecologist, said her hospital gave it to appreciative patients, but also encountered protesters who chained themselves to operating tables.Beginning in the 1980s, Dr. Baulieu received hate mail, some of it antisemitic. A poster in Canada featured Dr. Baulieu’s photo and the words “Wanted for Genocide.” One in San Francisco equated him with the Nazi death camp doctor Josef Mengele, calling them “blood brothers.” In New Orleans, a small bomb exploded at a conference at the time Dr. Baulieu would have been speaking if not for travel delays, he said.He also received grateful letters from America and pleas for the pill to be available there. Some at Roussel-Uclaf felt he hadn’t shared enough credit for RU-486. Not long after Dr. Baulieu won the Lasker Award, Dr. Teutsch, the chemist, was quoted as saying, “Étienne Baulieu is the father of the pill, but he is not the father of the compound.”For years, afraid that opposition in America would lead to boycotts of its other products, the company declined to seek approval of RU-486. In 1993, an abortion rights organization started a clandestine lab to make the pill in a suburban New York warehouse. In 1994, with the Clinton administration championing the pill, Roussel-Uclaf donated American rights to the Population Council, a nonprofit organization.The Food and Drug Administration gave RU-486 conditional approval in 1996, but large pharmaceutical companies wouldn’t manufacturer it, and full approval didn’t occur until 2000, after a small company, Danco Laboratories, agreed to make it.Today, as some states ban nearly all abortions and propose actions to target medication abortion, other states and the Biden administration have taken steps to expand access to abortion pills. Patients can have consultations with abortion providers via telemedicine and receive the prescribed pills by mail. A new F.D.A. rule will allow retail pharmacies like CVS to fill prescriptions for the pills. And in states with abortion bans, many patients order pills from an overseas telemedicine abortion organization.Still at workThe building containing Dr. Baulieu’s lab is named for one of his mentors: Gregory Pincus, an American scientist who helped invent the birth control pill.Julie Glassberg for The New York TimesThese days, scientific experimentation continues apace at Dr. Baulieu’s lab in the Grégory Pincus building, a boxy, teal-colored structure on a hospital campus that was previously the site of an 18th century prison.Dr. Baulieu has made discoveries about various steroid hormones, including the finding that some are synthesized in the brain; he called them “neurosteroids.” Today, his team studies Alzheimer’s and has started clinical trials on a new method to treat severe depression, based on Dr. Baulieu’s ideas about a receptor for a particular neurosteroid.“He discovered both the receptor and the function,” said Isabelle Villey, a biochemist who leads a small company headquartered at Dr. Baulieu’s lab.Dr. Baulieu’s office is jumbled with memorabilia, papers, books and art. Near a chalkboard with sketches of how the brain processes memories, there are avant-garde sculptures by his artist friends — including a mechanized representation of the sword he received upon being inducted into the French Academy of Sciences, where he later served as president. Recently, warmed by a scarf and a puffy down vest under a blazer, he gave an impromptu seminar, thumbing through one of his RU-486 articles.He remains energetic, barely slowed by his use of a cane and displaying only occasional hiccups in memory.Over dinner at a Montparnasse seafood restaurant, Dr. Baulieu said he was dismayed by anti-abortion politics and what he called the “scandalous” Supreme Court ruling in America. But, he said, “it’s good that my pill is accepted by a large number of women.”His outlook has been shaped by living nearly a century, marked by war, social upheaval and scientific innovation.“I’m optimistic,” Dr. Baulieu said, “because science helps you to be optimistic.”In his office, Dr. Baulieu gave an impromptu seminar about one of his scientific papers on RU-486.Julie Glassberg for The New York Times

The drug, Leqembi, may modestly slow cognitive decline in early stages of the disease but carries some safety risks. Still, data suggests it is more promising than the small number of other available treatments.The Food and Drug Administration on Friday approved a new Alzheimer’s drug that may modestly slow the pace of cognitive decline early in the disease, but also carries risks of swelling and bleeding in the brain.The approval of the drug, lecanemab, to be marketed as Leqembi, is likely to generate considerable interest from patients and physicians. Studies of the drug — an intravenous infusion administered every two weeks — suggest it is more promising than the scant number of other treatments available. Still, several Alzheimer’s experts said it was unclear from the medical evidence whether Leqembi could slow cognitive decline enough to be noticeable to patients.Even a recent report of findings from a large 18-month clinical trial, published in the New England Journal of Medicine and co-written by scientists from the lead company making the drug, concluded that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”Eisai, a Japanese pharmaceutical company, led the development and testing of the drug. It is partnering with the American company Biogen, maker of the controversial Alzheimer’s drug Aduhelm, for its commercialization and marketing, and the companies will split the profits equally.Eisai said it planned to release information about the price of Leqembi (pronounced le-KEM-bee) a few hours after the approval was announced. A preliminary report by the Institute for Clinical and Economic Review, an independent nonprofit organization that assesses the value of medicines, said that to be cost-effective for patients the price should be set between $8,500 and $20,600 a year.In its decision, the F.D.A. appeared to be acknowledging the vehement criticism that erupted when it approved Aduhelm in 2021 after both a committee of independent advisers and an F.D.A. council of senior officials said there was not enough evidence that it worked.Last week, an 18-month investigation by two congressional committees found that the approval process for Aduhelm was “rife with irregularities” and involved an unusually close collaboration with Biogen. In response, the F.D.A. said “the agency has already started implementing changes consistent with the committees’ recommendations.”With Leqembi, the F.D.A. included narrower and more cautionary language on the drug label than it initially had with Aduhelm. (After an outcry from physicians and others, it changed the Aduhelm label a month after its approval.)The Leqembi label says the drug should be used only for patients in early and mild stages of Alzheimer’s disease, matching the status of patients in the clinical trials of the drug. It instructs doctors not to treat patients without doing tests to confirm that they have one of the hallmarks of Alzheimer’s: a buildup of the protein amyloid, which Leqembi (like Aduhelm) attacks.“We have worked very hard with the F.D.A. to narrow the population down to a very specific one, the same as the clinical trials,” Ivan Cheung, the chairman and chief executive of Eisai’s United States operations, said in an interview.The Controversy Surrounding the Aduhelm Alzheimer’s DrugCard 1 of 5A troubled approval.

The two chains said they would begin the certification process under a new F.D.A. regulation that will allow retail pharmacies to dispense the prescription pills for the first time.Two major pharmacy chains will apply to sell abortion pills under a new Food and Drug Administration regulation that will allow the medication to be offered by retail pharmacies for the first time.The chains, CVS and Walgreens, said they planned to seek certification to sell the pill, mifepristone, the first pill used in the two-drug medication abortion regimen. Patients will still need a prescription from a certified health care provider, but the new federal action could significantly expand access to medication abortion because it allows any pharmacy that agrees to accept those prescriptions and abide by certain other criteria to dispense the pills in its stores and by mail order.The pharmacy chains did not provide details about when they expected to be able to offer the pills, in which states or whether they would offer them only in stores or via mail order, or both. They said they would comply with laws in states that ban or restrict abortion, currently about half of the states.“We plan to seek certification to dispense mifepristone where legally permissible,” Amy Thibaut, a spokeswoman for CVS, said.A spokesman for Walgreens, Fraser Engerman, said in statement: “We intend to become a certified pharmacy under the program. We are working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra F.D.A. requirements and will dispense these consistent with federal and state laws.”Abortion pills, already used in more than half of pregnancy terminations in the United States, are becoming even more sought after in the aftermath of the Supreme Court decision last year overturning the federal right to abortion. With conservative states banning or sharply restricting abortion, the pills have increasingly become central to political and legal battles, and the decision to sell them could make the big chains another focus of the country’s divisive abortion debate.The steps for pharmacies to become certified to dispense mifepristone are not difficult, but they involve some administrative requirements that go beyond the process pharmacies use with most other medications, such as designating an employee to ensure compliance..css-1v2n82w{max-width:600px;width:calc(100% – 40px);margin-top:20px;margin-bottom:25px;height:auto;margin-left:auto;margin-right:auto;font-family:nyt-franklin;color:var(–color-content-secondary,#363636);}@media only screen and (max-width:480px){.css-1v2n82w{margin-left:20px;margin-right:20px;}}@media only screen and (min-width:1024px){.css-1v2n82w{width:600px;}}.css-161d8zr{width:40px;margin-bottom:18px;text-align:left;margin-left:0;color:var(–color-content-primary,#121212);border:1px solid var(–color-content-primary,#121212);}@media only screen and (max-width:480px){.css-161d8zr{width:30px;margin-bottom:15px;}}.css-tjtq43{line-height:25px;}@media only screen and (max-width:480px){.css-tjtq43{line-height:24px;}}.css-x1k33h{font-family:nyt-cheltenham;font-size:19px;font-weight:700;line-height:25px;}.css-1hvpcve{font-size:17px;font-weight:300;line-height:25px;}.css-1hvpcve em{font-style:italic;}.css-1hvpcve strong{font-weight:bold;}.css-1hvpcve a{font-weight:500;color:var(–color-content-secondary,#363636);}.css-1c013uz{margin-top:18px;margin-bottom:22px;}@media only screen and (max-width:480px){.css-1c013uz{font-size:14px;margin-top:15px;margin-bottom:20px;}}.css-1c013uz a{color:var(–color-signal-editorial,#326891);-webkit-text-decoration:underline;text-decoration:underline;font-weight:500;font-size:16px;}@media only screen and (max-width:480px){.css-1c013uz a{font-size:13px;}}.css-1c013uz a:hover{-webkit-text-decoration:none;text-decoration:none;}What we consider before using anonymous sources. Do the sources know the information? What’s their motivation for telling us? Have they proved reliable in the past? Can we corroborate the information? Even with these questions satisfied, The Times uses anonymous sources as a last resort. The reporter and at least one editor know the identity of the source.Learn more about our process.For chains like CVS and Walgreens, the most logistically intricate step might be the requirement that pharmacies keep confidential the names of the certified health providers who prescribe mifepristone to protect their privacy and safety.To fulfill that requirement, a chain like CVS would not be able to list a doctor’s name in a companywide database, for example, and would have to keep that information restricted to the store that fills that doctor’s prescriptions, according to an official with Danco Laboratories, one of the two makers of mifepristone, who spoke on the condition of anonymity because of the company’s concerns about threats from abortion opponents.Mifepristone, which blocks a hormone necessary for pregnancy development, is authorized by the F.D.A. to be taken in the first 10 weeks of pregnancy, although many clinics and telemedicine providers have begun offering it up to 12 or 13 weeks into pregnancy. This is a step they can legally take because most states allow physicians to use medical discretion to prescribe a drug for a particular “off label” use if there is scientific evidence that it is safe and effective for that use. The World Health Organization supports medication abortion through 12 weeks’ gestation, and studies suggest it is safe and effective during that time frame.The second drug in the regimen, misoprostol, has never been as tightly restricted as mifepristone and is used for many different medical conditions. It is easily obtained at pharmacies through a typical prescription process. Misoprostol, which causes contractions that expel pregnancy tissue, is taken 24 to 48 hours after mifepristone.Mifepristone is currently approved only for abortion. But it is also used in the treatment of some miscarriages, and there may be pressure for pharmacies to dispense it for that purpose as well. Recently, dozens of groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, filed a citizen petition asking the F.D.A. to take action to make it easier for mifepristone to be used for miscarriages.

Mifepristone, the first of two drugs in medication abortions, previously had to be dispensed only by clinics, doctors or a few mail-order pharmacies. Now, if local drugstores or chains like CVS agree to certain rules, they can provide it.For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication.Until now, mifepristone — the first pill used in the two-drug medication abortion regimen — could be dispensed only by a few mail-order pharmacies or by specially certified doctors or clinics. Under the new F.D.A. rules, patients will still need a prescription from a certified health care provider, but any pharmacy that agrees to accept those prescriptions and abide by certain other criteria can dispense the pills in its stores and by mail order.The change comes as abortion pills, already used in more than half of pregnancy terminations in the U.S., are becoming even more sought after in the aftermath of last year’s Supreme Court decision overturning the federal right to abortion. With conservative states banning or sharply restricting abortion, the pills have increasingly become the focus of political and legal battles, which may influence a pharmacy’s decision about whether or not to dispense the medication.The F.D.A. did not issue an announcement but updated its website to reflect the decision and added to a series of questions and answers. The two makers of the pill, Danco Laboratories and GenBioPro, released statements saying the agency had informed them of the action.The action is the latest step taken by the federal government to expand access to abortion pills by easing some of the restrictions that have applied to mifepristone since it was approved in 2000.In December 2021, the F.D.A. said it would permanently lift the requirement that patients obtain mifepristone in person from a health provider, a step that paved the way for telemedicine abortion services which conduct medical consultations with patients by video, phone or online questionnaires and then arrange for them to receive the prescribed pills by mail.On Tuesday, the F.D.A. officially removed the in-person requirement from its regulatory rule book for mifepristone, leaving in place the remaining two requirements: that health providers be certified to show they have the knowledge and ability to treat abortion patients and that patients complete a consent form.More on Abortion Issues in AmericaWhen Does Life Begin?: We explore the question at the heart of America’s abortion debate, one that pushes the limits of politics, science, religion and philosophy.Morning-After Pills: The Food and Drug Administration revised its guidance on the most commonly used emergency contraceptives, making clear they are not abortion pills.Abortion Pills: In a move that could significantly expand access to medication abortions, the F.D.A. moved to allow retail pharmacies to offer abortion pills in the United States.‘Parental Involvement’ Laws: As abortion access dwindles in America, these laws weigh heavily on teenagers — who may need a court’s permission to end their pregnancies.Mifepristone, which blocks a hormone necessary for pregnancy development, is authorized by the F.D.A. to be taken in the first 10 weeks of pregnancy, although many clinics and telemedicine providers have begun offering it up to 12 or 13 weeks into pregnancy, a step they can legally take because there is scientific evidence that the pills are safe and effective in that time frame.The second drug in the regimen, misoprostol, has never been as tightly restricted as mifepristone and is used for many different medical conditions; it is easily obtained at pharmacies through a typical prescription process. Misoprostol, which causes contractions that expel pregnancy tissue, is taken 24 to 48 hours after mifepristone.Tuesday’s action is a result of an agreement between the F.D.A. and the companies that make the pills. The agreement was worked out in negotiations that took about a year and considered issues such as whether to allow pharmacies to offer the pills in stores or only via mail order and how to keep the identity of prescribing doctors confidential to protect their privacy and safety, according to people familiar with the discussions.Whether large pharmacy chains and local drugstores would opt to make the pills available was not immediately clear Tuesday. A spokesman for Walgreens, Fraser Engerman, said the company would review the F.D.A.’s decision and would “continue to enable our pharmacists to dispense medications consistent with federal and state law.”.css-1v2n82w{max-width:600px;width:calc(100% – 40px);margin-top:20px;margin-bottom:25px;height:auto;margin-left:auto;margin-right:auto;font-family:nyt-franklin;color:var(–color-content-secondary,#363636);}@media only screen and (max-width:480px){.css-1v2n82w{margin-left:20px;margin-right:20px;}}@media only screen and (min-width:1024px){.css-1v2n82w{width:600px;}}.css-161d8zr{width:40px;margin-bottom:18px;text-align:left;margin-left:0;color:var(–color-content-primary,#121212);border:1px solid var(–color-content-primary,#121212);}@media only screen and (max-width:480px){.css-161d8zr{width:30px;margin-bottom:15px;}}.css-tjtq43{line-height:25px;}@media only screen and (max-width:480px){.css-tjtq43{line-height:24px;}}.css-x1k33h{font-family:nyt-cheltenham;font-size:19px;font-weight:700;line-height:25px;}.css-1hvpcve{font-size:17px;font-weight:300;line-height:25px;}.css-1hvpcve em{font-style:italic;}.css-1hvpcve strong{font-weight:bold;}.css-1hvpcve a{font-weight:500;color:var(–color-content-secondary,#363636);}.css-1c013uz{margin-top:18px;margin-bottom:22px;}@media only screen and (max-width:480px){.css-1c013uz{font-size:14px;margin-top:15px;margin-bottom:20px;}}.css-1c013uz a{color:var(–color-signal-editorial,#326891);-webkit-text-decoration:underline;text-decoration:underline;font-weight:500;font-size:16px;}@media only screen and (max-width:480px){.css-1c013uz a{font-size:13px;}}.css-1c013uz a:hover{-webkit-text-decoration:none;text-decoration:none;}What we consider before using anonymous sources. Do the sources know the information? What’s their motivation for telling us? Have they proved reliable in the past? Can we corroborate the information? Even with these questions satisfied, The Times uses anonymous sources as a last resort. The reporter and at least one editor know the identity of the source.Learn more about our process.The steps for pharmacies to become certified to dispense mifepristone are not difficult, but they involve some administrative requirements that go beyond the process pharmacies use with most other medications, such as designating an employee to ensure compliance. Given the time and resources required by those steps, some pharmacies may not consider it worthwhile to offer a medication that only a small percentage of their customers may use.But while abortion pills may constitute a small percentage of a pharmacy’s sales, they could have a big impact on its public profile. Calculations about public perception and the highly polarized political landscape are also likely to influence a pharmacy’s decision.In about half the states, abortion bans or restrictions would make it illegal or very difficult for pharmacies to provide abortion pills. In states where abortion remains legal, pharmacies may face customer demand for the medication or public pressure from abortion rights advocates and health providers. National chains could decide to offer the medication in those states while not providing it in their stores in restrictive states.Reaction from advocates on both sides of the abortion debate reflected the country’s deep divisions.“The Biden administration has once again proved that it values abortion industry profits over women’s safety and unborn children’s lives,” said Marjorie Dannenfelser. the president of Susan B. Anthony Pro-life America. “Abortion activists want to turn every post office and pharmacy into an abortion business, and the Biden F.D.A. is a willing participant.” Kirsten Moore, the director of the Expanding Medication Abortion Access project, said: “By allowing brick-and-mortar pharmacies to dispense medication abortion care, the F.D.A. is treating medication abortion like the safe, effective, time-sensitive care that it is.”Mifepristone is currently only approved for abortion. But it is also used in the treatment of some miscarriages, and there may be pressure for pharmacies to dispense it for that purpose as well. Recently, dozens of groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, filed a citizen petition asking the F.D.A. to take action to make it easier for mifepristone to be used for miscarriages.An official with Danco, which for years was the only company to produce the medication, branded as Mifeprex, said the company expected that smaller independent pharmacies might be first to dispense the drug and that it might take the bigger chains longer, partly because of the logistics involved in complying with the requirements.The official, who spoke on the condition of anonymity because of the company’s concerns about threats from abortion opponents, said that one logistically intricate step for big chains would be implementing the companies’ requirement that pharmacies keep confidential the names of health providers who prescribe mifepristone. A chain like CVS would not be able to list a doctor’s name in a companywide database, for example, and would have to keep that information restricted to the store that fills that doctor’s prescriptions, the Danco official said.She predicted that early adopters might include small pharmacies that typically serve university health services or retail pharmacies on hospital campuses, adding that the company wasn’t expecting a boom in sales from the rule change. She said it was also possible that more health care providers would decide to become prescribers if they could now write prescriptions that pharmacies could fill instead of having to stock the medication themselves.“For some people, this is going to be a huge improvement on their ability to access the drug and be able to even consider this as a choice for themselves,” the Danco official said. “For other people, not necessarily. Maybe they don’t want to go into their small mom-and-pop pharmacy. They’d rather receive it from a mail order where there’s just no interaction that way.”Evan Masingill, the chief executive of GenBioPro, which makes the generic version of mifepristone, said in a statement: “Today’s F.D.A. announcement expands access to medications that are essential for reproductive autonomy and is a step in the right direction that is especially needed to increase access to abortion care.”

Labels of Plan B One-Step had previously said, without scientific evidence, that the pill might block fertilized eggs from implanting in the womb.The Food and Drug Administration on Friday significantly changed the information that will be in every box of the most widely used emergency contraceptive pills to make clear that they do not prevent a fertilized egg from implanting in the womb. The agency explained in an accompanying document that the products cannot be described as abortion pills.Up to now, packages of the brand-name pill, Plan B One-Step, as well as generic versions of it have said that the pill might work by preventing a fertilized egg from implanting in the womb — language that scientific evidence did not support. That wording led some abortion opponents and politicians who equate a fertilized egg with a person to say that taking the morning-after pill could be the equivalent of having an abortion or even committing murder.The F.D.A. revised the leaflets inserted in packages of pills to say that the medication “works before release of an egg from the ovary,” meaning that it acts before fertilization, not after. The package insert also says the pill “will not work if you’re already pregnant, and will not affect an existing pregnancy.”In a question-and-answer document posted on the F.D.A.’s website, the agency explicitly addressed the abortion issue. In answer to the question, “Is Plan B One-Step able to cause an abortion?” the agency writes: “No.” It added: “Plan B One-Step prevents pregnancy by acting on ovulation, which occurs well before implantation. Evidence does not support that the drug affects implantation or maintenance of pregnancy after implantation, therefore, it does not terminate a pregnancy.”Since the Supreme Court overturned the ruling that ensured the national right to abortion, advocates of abortion rights have warned that some conservative states may outlaw or restrict morning-after pills on the erroneous grounds that they might cause abortions. Advocates and reproductive health providers have also worried that people who are misinformed about how the pills work may decline to use an effective tool to prevent unwanted pregnancies.For at least a decade, the pills have figured in political debates about abortion. During the 2012 presidential election, Mitt Romney called emergency contraceptives “abortive pills,” and two other Republican presidential candidates, Newt Gingrich and Rick Santorum, made similar statements.Some conservative states allow pharmacists or pharmacies to refuse to carry Plan B, which was approved in 1999 and is available without a prescription. And a recent study found that more than 60 percent of about 1,400 people surveyed believed that morning-after pills work by preventing the implantation of a fertilized egg.But scientific evidence has never shown that Plan B affects a fertilized egg’s ability to attach to the uterus. The F.D.A. acknowledged as much 10 years ago, after a 2012 investigation by The New York Times, when a spokeswoman for the agency said that “the emerging data on Plan B suggest that it does not inhibit implantation.”As a result of The Times’s reporting, MedlinePlus, a website run by the National Institutes of Health, deleted passages suggesting emergency contraceptives could disrupt implantation. Other health and medical websites made similar changes. In 2013, European health authorities revised the label of Norlevo, a pill that is identical to Plan B, to say that it “cannot stop a fertilized egg from attaching to the womb.”The F.D.A. said it made the change now because it had completed a review of a 2018 application to alter the label that was submitted by Foundation Consumer Healthcare, a company that in 2017 bought the Plan B brand from Teva Pharmaceutical Industries. Agency officials said the pandemic delayed the review process and that the timing was not motivated by political considerations.Plan B One-Step and its generic versions — including brands like Take Action, My Way and Option 2 — contain levonorgestrel, one of a class of hormones called progestins that are also found at lower doses in birth control pills and intrauterine devices. The pills are most effective in preventing pregnancy if taken within 72 hours of sexual intercourse, although they can sometimes work if taken within five days.Another type of morning-after pill, marketed as Ella and containing a compound called ulipristal acetate, is only available by prescription and is not affected by the F.D.A.’s label change. There has been less research on this type of pill, but studies suggest that it is highly unlikely to prevent implantation of a fertilized egg. In 2009, after months of scrutiny, Ella was approved for sale in overwhelmingly Catholic Italy, where laws would have barred it if it had been considered to induce abortions.According to data published in 2021 by the Centers for Disease Control and Prevention, nearly one-quarter of women of reproductive age who have sex with men answered yes to the question: “Have you ever used emergency contraception, also known as ‘Plan B,’ ‘Preven,’ ‘Ella,’ ‘Next Choice,’ or ‘Morning after’ pills?” The agency did not break down the data by the type of pills taken.As far back as the 1999 approval process, the maker of Plan B — Barr Pharmaceuticals, later acquired by Teva — asked the F.D.A. not to list an implantation effect on the label, The Times reported in 2012.Experts said implantation was likely placed on the label partly because daily birth control pills, some of which contain Plan B’s active ingredient, appear to alter the endometrium, the lining of the uterus into which fertilized eggs implant. Altering the endometrium has not been proven to interfere with implantation. But in any case, scientists said that unlike the accumulating doses of daily birth control pills, morning-after pills do not have time to affect the uterine lining.By 2007, evidence was accumulating that morning-after pills did not block implantation. In 2009 to 2010, during discussions about making Plan B available over the counter for all ages, Teva also asked that implantation be deleted from the label.

The tally is less than 1 percent of all deaths linked to the coronavirus, but it shows that it is possible to die from lingering symptoms after infection.Long Covid has caused or contributed to at least 3,500 deaths in the United States, an analysis of death certificates by the Centers for Disease Control and Prevention found.The study, published on Wednesday, is believed to be the first nationwide examination of whether long Covid or related terms appear in official American death records. While it found that such phrases were recorded in only a tiny proportion of the more than a million deaths tied to infection with the coronavirus, the researchers and other experts said the results added to growing recognition of how serious long-term post-Covid medical problems can be.“It’s not one of the leading causes of death, but, considering that this is the first time that we’ve looked at it and that long Covid is an illness that we’re learning more about day after day, the major takeaway is that it is possible for somebody to die and for long Covid to have played a part in their death,” said Farida Ahmad, a health scientist at the National Center for Health Statistics at the C.D.C. who led the study.Long Covid is a complex constellation of symptoms that can last for months or longer and can affect virtually every organ system. Some of the most debilitating post-Covid symptoms are breathing problems, heart issues, extreme fatigue and cognitive and neurological issues.The researchers looked at death certificates in every state and Washington, D.C., dated from Jan. 1, 2020 to June 30, 2022. They found 1,021,487 certificates that included a diagnostic code for Covid-19 as an underlying or contributing cause of death. Of those, 3,544 — or 0.3 percent of the total — listed long Covid or terms like post-Covid syndrome, chronic Covid or long-haul Covid. Ms. Ahmad and experts not involved in the research said the number of deaths related to long Covid in the study was almost certainly an underestimate. It has taken time for the condition to be recognized and identified by doctors and other medical providers. And the study was not able to include a new diagnostic code for long Covid because it was not yet being used in reporting of deaths in the United States, the researchers said.“This new research is important in raising a concern, but it should be followed with more definitive work,” said Dr. Jeffrey Martin, chief of the division of clinical epidemiology in the department of epidemiology and biostatistics at the University of California, San Francisco, who was not involved in the research.“Historically, death certificates have been incomplete in explaining how a person died,” said Dr. Martin, who suggested that future research should include interviewing patients’ doctors and family members and evaluating their medical records.The study found that more death certificates mentioned long Covid after 2020 and that the condition was more likely to be listed on death certificates in the weeks or months after a peak of Covid cases, Ms. Ahmad said.The study found that some of the long Covid patterns related to age, sex, race and ethnicity differed from those seen in deaths caused by the initial infection. For example, while Black and Hispanic people had higher death rates from the initial coronavirus infection than non-Hispanic whites, those groups did not have higher death rates related to long Covid, the study found.The researchers suggested that the difference might be partly because of systemic disparities that have resulted in less access to health care for Black and Hispanic patients, who might not have received appropriate long-Covid diagnoses. The study said it was also possible that, because Black and Hispanic patients died at higher rates from the initial illness than white patients, they might have “fewer Covid-19 survivors left to experience long-Covid conditions.”Nearly 57 percent of deaths related to long Covid were in people 75 and older. Nearly a third of the death certificates that mentioned long Covid listed the underlying or main cause of death as a non-Covid condition such as heart disease, cancer or Alzheimer’s.“This is just scratching the surface — this is a first look,” said David Putrino, the director of rehabilitation innovation for the Mount Sinai Health System in New York, who was not involved in the study.He said the study appeared to be primarily capturing deaths of people who experienced serious initial infection with the coronavirus and who survived that phase but went on to have organ damage and other severe complications. He said other deaths related to long Covid should be studied, including deaths by suicide of people who had devastating post-Covid symptoms.Another report published on Wednesday, by the Documenting Covid-19 project, offered a snapshot of deaths related to long Covid by looking at death certificates in 2020 and 2021 in Minnesota, New Mexico and a few other locations. That report, conducted by the Brown Institute for Media Innovation at Columbia University and MuckRock, a public records foundation, found that 18 of the 28 deaths associated with long Covid in Minnesota during those years were in people over 80 years old and that most of the patients had worked in blue-collar jobs and lacked a college degree. In New Mexico, about a third of the 13 deaths related to long Covid were in people under 60, and some were frontline or essential workers, the report said.Experts evaluating the C.D.C. study cautioned that it was both an incomplete picture of mortality linked to long Covid and of the larger toll of the condition, which has been estimated by the Government Accountability Office to have affected 7.7 million to 23 million people in the United States.“This is an important thing to explore and study, but it shouldn’t be used as a proxy for saying, Oh, well, long Covid isn’t that severe because look how few deaths there are,” Dr. Putrino said. “We should not be measuring the damage that long Covid does by deaths alone.”

The drug, lecanemab, made by Eisai and Biogen, also carried risks of brain swelling and bleeding and should be studied further, a report of the findings said.The hotly anticipated results of a clinical trial of an experimental Alzheimer’s drug suggest that the treatment slowed cognitive decline somewhat for people in the early stages of the disease but also caused some patients to experience brain swelling or brain bleeding.The new data, released Tuesday evening, offered the first detailed look at the effects of the drug, lecanemab, and comes two months after its manufacturers, Eisai and Biogen, stoked excitement by announcing that the drug had shown positive results. Alzheimer’s experts said the new information showed reason for both optimism and caution.“The benefit is real; so too are the risks,” said Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, who was not involved in the research.A report of the findings published in the New England Journal of Medicine said that over 18 months, lecanemab “resulted in moderately less decline on measures of cognition and function,” compared with patients receiving a placebo. Still, the study of nearly 1,800 patients with mild symptoms, which was funded by the companies and co-written by scientists at Eisai, concluded that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”The companies’ initial announcement in September had sent their stock prices soaring because the field of Alzheimer’s drug development has been marked by years of failures.It also followed months of controversy over the Food and Drug Administration’s decision last year to approve another Alzheimer’s drug, Aduhelm, also manufactured by Biogen, despite studies that did not prove the treatment worked and showed it carried significant safety risks. After Medicare decided to sharply limit its coverage of Aduhelm, citing risks and unclear benefit, the expensive drug was essentially sidelined from the marketplace.Like Aduhelm, lecanemab — given as an intravenous infusion every two weeks — is a monoclonal antibody that targets a protein, amyloid, which clumps into plaques in the brains of people with Alzheimer’s. Years of trials of various anti-amyloid compounds have not conclusively shown that clearing or reducing levels of the protein can help patients’ memory or thinking problems. Earlier this month, another anti-amyloid monoclonal antibody, gantenerumab, made by Roche and Genentech, failed to show any cognitive benefit.That history gives the lecanemab trial added significance, marking the first time that attacking amyloid has clearly correlated with a slower rate of cognitive decline, experts say. But because the rate was not dramatically slower, several doctors who treat Alzheimer’s questioned whether the effect would be noticeable to patients or their families.The clinical trial found that after 18 months, patients receiving lecanemab declined 27 percent slower — a difference of 0.45 of a point on an 18-point cognitive scale.“The clear issue is what does this small benefit mean in terms of meaningful change for patients and caregivers,” said Dr. Kristine Yaffe, a professor of neurology and psychiatry at the University of California, San Francisco, who was not involved in the study. “And how do we balance that” with significant safety risks, the requirement for frequent infusions and “what will be, undoubtedly, a high financial cost,” she said.Dr. Madhav Thambisetty, a neurologist and a senior investigator at the National Institute on Aging, said that “from the perspective of a scientist, it is exciting that an experimental treatment targeting brain amyloid in Alzheimer’s disease appears to slow cognitive decline.” But, Dr. Thambisetty, who was not speaking on behalf of the federal aging agency, added: “From the perspective of a physician caring for Alzheimer’s patients, the difference between lecanemab and placebo is well below what is considered to be a clinically meaningful treatment effect.” About six million people in the United States and roughly 30 million globally have Alzheimer’s, a number expected to double by 2050. Lecanemab was tested on patients with mild cognitive impairment or early-stage Alzheimer’s, whose brains contained higher-than-normal levels of amyloid — a description that applies to about 1.5 million Americans.An illustration of amyloid protein disrupting the function of nerve cells in a brain with Alzheimer’s disease. nobeastsofierce/ShutterstockThe F.D.A. is expected to decide by Jan. 6 whether to grant lecanemab the type of approval it gave Aduhelm — a designation called “accelerated approval,” which can be given to drugs with uncertain benefit if they are for serious diseases with few treatments and attack a biological element of the disease. Accelerated approval requires companies to conduct further trials to prove whether the drug works.Eisai, which was presenting its data Tuesday night at a conference in San Francisco, has said it will use the new information to seek full approval early next year if the the January decision is favorable.“While the prediction is that the F.D.A. will approve lecanemab, there are issues of safety,” said Dr. Sam Gandy, an Alzheimer’s clinician who is director of the Mount Sinai Center for Cognitive Health and was not involved in the study.Concerns about the safety of lecanemab — at least for some types of patients, especially those taking blood thinners — have been fueled recently by news reports of the deaths of two patients who experienced brain swelling and brain bleeding. Swelling and bleeding are known side effects of several anti-amyloid drugs. If lecanemab ends up being considered unsafe for people taking blood thinners, then tens of thousands of patients could be excluded.The study published Tuesday reported six deaths among the trial’s 898 lecanemab patients and seven deaths among the 897 patients receiving placebo. The authors wrote that no deaths were considered to be related to lecanemab or to have occurred with brain swelling or bleeding.The two recently reported deaths occurred after the 18-month randomized portion of the trial, so the deaths of those trial participants are not included in the study and it is not known if those patients received lecanemab or placebo during that time. But after the 18 months, both patients opted to receive lecanemab in an open-label extension study.The patients, whose cases were reported by the journal Science and STAT, had other medical complications. One case involved a 65-year-old woman who suffered a stroke and, after receiving a standard treatment for stroke-related blood clots, suffered serious brain bleeding and died a few days later. A neuropathologist who conducted an autopsy at the request of the woman’s husband told the journal that lecanemab likely weakened her blood vessels and made them vulnerable to bursting when she received the blood-clotting treatment.The other case involved a man in his late 80s who was taking a blood thinner for a heart condition and had also experienced falls and ministroke-like events shortly before his death.In a statement, Eisai, citing the patients’ other medical conditions and blood-thinning medication, said, “It is Eisai’s assessment that the deaths cannot be attributed to lecanemab.” The company said that in the trial’s randomized and open-label phases, the total rate of deaths with major brain bleeds was 0.1 percent for patients in both the lecanemab and placebo groups.Dr. Thambisetty said the two deaths add to questions about lecanemab’s safety issues “in real world clinical practice where patients are likely to be sicker and have multiple other medical conditions in contrast to carefully selected patients in clinical trials.”Nonetheless, the data on lecanemab, which Dr. Gandy noted attacks a different form of amyloid than previously tested drugs do, showed significantly lower rates of swelling and bleeding than with Aduhelm.Nearly 13 percent of patients receiving lecanemab experienced brain swelling, which was mild or moderate in most cases, while less than 2 percent of patients receiving the placebo experienced such swelling, the study reported. Most brain swelling did not cause any symptoms and generally resolved within a few months. About 17 percent of lecanemab patients experienced brain bleeding, compared with 9 percent of patients receiving the placebo. The most common symptom from brain bleeds was dizziness, the study said.The authors reported that “serious adverse events” occurred in 14 percent of lecanemab patients and 11 percent of those receiving placebo. Nearly 7 percent of lecanemab patients dropped out of the trial because of negative side effects, more than twice the percentage of placebo recipients who dropped out. More than a quarter of the lecanemab patients experienced adverse infusion-related reactions, which included fever and flu-like symptoms, usually with the first dose. A much smaller percentage of placebo patients experienced those reactions, the study found.The main positive outcome of the study was that lecanemab patients declined cognitively by 1.21 points, while patients receiving placebo declined by 1.66 points on the 18-point scale, which assesses functions like memory, problem-solving and daily activities via interviews with patients and caregivers.This result was supported by secondary measures in the trial, including three other cognitive tests, bolstering the possibility that the drug is having a real effect, experts said. In addition, on all the measures, patients began showing slower decline several months after starting lecanemab, and the pace slowed further during the 18-month trial.The trial made an effort to include more participants of color than have typically been enrolled in Alzheimer’s trials. About 25 percent of those who participated in the trial in the United States were Black or Hispanic, the study reported. It also allowed people with various medical conditions to participate, including hypertension, diabetes, heart disease, obesity and kidney disease.Experts noted that because patients in trials are carefully monitored, implications for the general population of Alzheimer’s patients can be harder to predict.Dr. Yaffe said that “of all the amyloid antibody trials, this one seems most clearly positive and convincing,” which, she added, can be considered “good news overall for the field.”Still, for “real world” patients with more varied Alzheimer’s pathology, “the effect will be most likely even less,” she said, adding, “I wonder if there are some folks who really benefit, but this trial cannot say.”

It is one of many colleges and universities deliberating over how to respond to the fall of Roe v. Wade.Barnard, the private women’s college in New York City, will begin offering abortion pills on campus next year, college officials announced Thursday.The decision, to take effect in September, signals how the nation’s colleges and universities are becoming another front in the nation’s pitched battle over abortion after the Supreme Court decision to overturn Roe v. Wade.“I think we’re putting a stake in the ground that we believe that health and wellness is really the institution’s responsibility for students, and we want to do everything we can to support our students,” Sian L. Beilock, the president of Barnard, which operates in partnership with Columbia University, said in an interview.In an email sent out to the campus Thursday, Barnard officials wrote, “The overturning of Roe v. Wade after 50 years will likely decrease college accessibility, result in lower graduation rates, and derail employment trajectories.” The email said that while abortion access in New York was currently strong, “we are also preparing in the event that there is a barrier to access in the future, for any reason.”This summer, Massachusetts enacted a law requiring the state’s public colleges and universities to submit plans by November 2023 to provide abortion pills to students, either through their campus health centers or through a local service that is readily accessible to students. By January, California’s public colleges and universities will be required by a state law enacted in 2019 to offer the pills.At the same time, colleges in states with abortion bans or strict restrictions are imposing measures to rein in campus reproductive health services.Last month, the general counsel of the University of Idaho sent a memo to all employees saying that under Idaho’s near-total ban on abortion, which took effect in August, employees of the state university cannot counsel patients about abortion or refer them to abortion services. If employees do so, the memo said, they could be charged with a misdemeanor or a felony under the new law, lose their job and be permanently barred from state employment.The memo also said that the Idaho law prohibited employees from dispensing emergency contraception, except in cases of rape, and added that, because it was unclear how broadly the law applied to other methods of contraception, “we are advising a conservative approach here, that the university not provide standard birth control itself.”Condoms can be provided only if they are intended to stop the spread of sexually transmitted diseases, the memo said, “not for purposes of birth control.”Dr. Marina Catallozzi, Barnard’s vice president of health and wellness and chief health officer. “We feel like this is of course a natural step in caring for a population of college students who are at risk of pregnancy,” she said.Barnard CollegeSian L. Beilock, Barnard’s president. “We believe that health and wellness is really the institution’s responsibility for students,” she said.Barnard CollegeIn general, colleges and universities have cautiously approached the question of whether to offer medication abortion. Rachel Mack, a spokeswoman for the American College Health Association, which represents more than 700 institutions of higher education, said the issue was being discussed among colleges and the association’s reproductive rights task force.“Not all schools have the resources to provide such a service and may refer out to community providers,” Ms. Mack said. “Campuses vary greatly in their available resources — this can be due to location, the needs of their student population and many other factors.”A few colleges decided to offer abortion pills long before this year’s Supreme Court decision overturning Roe. The University of California, Berkeley, has been doing so for a couple of years. A study published in 2018 estimated that 322 to 519 students at California’s public universities sought medication abortion each month and that many faced obstacles of cost, of travel distance to providers and of long waits for appointments.In a survey by the American College Health Association in 2020, 2.5 percent of 122 college health centers said they provided medication abortion on campus, while 87 percent said they provided referrals to patients seeking abortion.At Barnard, Dr. Marina Catallozzi, the vice president of health and wellness and chief health officer, said that adding medication abortion was already on the college’s radar before some students met with health services officials this year to ask the school to provide it.“We feel like this is of course a natural step in caring for a population of college students who are at risk of pregnancy,” Dr. Catallozzi said, noting that Barnard already offered a range of reproductive health services, including a campus vending machine for emergency contraception for students who want to obtain the morning-after pill in a more private way than visiting the wellness center.“With every reproductive health decision, but particularly around a pregnancy,” she said, “we want to make sure that students have all of the options — if they want to continue a pregnancy, if they want to continue and go on to adoption, if they want to terminate.”The Wellness Spot at Barnard College, a health hub that offers services, workshops and other assistance to students.Barnard CollegeBarnard officials said they decided not to offer the pills immediately in order to spend the next several months training staff, developing protocols and working out logistics. They said that the pills would be covered by the college’s health insurance plan and that there would be emergency funding available for students without insurance or those who do not want to use their parents’ insurance policies.Medication abortion, legalized in the United States in 2000, typically involves two drugs: mifepristone, which blocks a hormone necessary for pregnancy development, followed 24 to 48 hours later by misoprostol, which causes contractions that expel pregnancy tissue. The Food and Drug Administration requires that mifepristone be dispensed by specially certified providers, but patients can take the pills on their own at home or any location they choose.Patients with some medical issues, like bleeding disorders, are not prescribed abortion pills. But for the many patients who are medically eligible, data indicates medication abortion is safe and effective, with a small percentage of patients requiring a procedure to fully remove pregnancy tissue and an even smaller proportion experiencing serious complications.Dr. Catallozzi and Dr. Beilock said very few students at Barnard had sought abortions in recent years. Those who do are typically referred to services affiliated with Columbia University Irving Medical Center, and that relationship will continue. Dr. Catallozzi said she expected that some students who live in dorms may prefer to go to the medical center for surgical abortions, which do not involve the days of bleeding that typically follow taking the pills.Dr. Catallozzi also said that the college wanted to offer the option in case New York’s abortion services become overwhelmed with patients from states with restrictions. “It makes sense for us to say, ‘Hey, the landscape’s changing all over the country. Let’s make sure that if needed, we’re prepared,’” she said.In the 2023 academic year, Dr. Beilock will become the president of Dartmouth College. Asked if she would recommend that Dartmouth offer abortion pills, Dr. Beilock said: “I’m looking forward to getting to know the Dartmouth community better. Right now, I’m president of Barnard and thinking, with our experts, about what’s best for Barnard.”

The list price of the therapy, Relyvrio, is much higher than an economic research group recommends, but the company says most patients will pay very little themselves.A new medication for A.L.S., the devastating neurological disorder that causes paralysis and death, will have a list price of $158,000 a year, its manufacturer disclosed Friday.The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.Relyvrio was approved by the Food and Drug Administration on Thursday, even though the agency’s analysis 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.The F.D.A. decided to greenlight the drug instead of waiting until 2024 for results of a large clinical trial partly because the treatment is considered to be safe. The agency said that although the evidence of effectiveness was uncertain, “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.”A.L.S., or amyotrophic lateral sclerosis — also called Lou Gehrig’s disease — often strikes patients in the prime of life and frequently causes death within two to five years. It is diagnosed in about 6,000 people worldwide each year, and Amylyx estimates that there are about 29,000 people living with the disease in the United States.The Fight Against A.L.S.The illness, also called Lou Gehrig’s disease, robs people of their ability to move, speak, eat and ultimately breathe.Relyvrio: The experimental treatment for A.L.S. conceived a decade ago by two college students received the Food and Drug Administration’s approval, despite questions about its effectiveness.A Runner’s Mission: After surpassing the average life expectancy for people with the disease, Andrea Peet decided to race a new kind of clock: 50 marathons in 50 states.Brain Implant: A man who is fully paralyzed by A.L.S. was able to communicate using only his thoughts.Rethinking Care: In 2017, Brian Wallach was diagnosed with A.L.S. Now, his startup aims to help other patients make the most of their time.Amylyx officials predicted that most patients would pay little or nothing for the treatment because the company expects insurers, both private and public, to cover it. Amylyx plans to provide it free to uninsured patients experiencing financial hardship.Still, the list price is much higher than that recommended by the Institute for Clinical and Economic Review, a nonprofit organization that evaluates the value of medicines. In a statement, the group’s chief medical officer, Dr. David Rind, said that while “there are clear benefits to patients with a rapidly fatal disease to have early access to a safe therapy,” his organization had concluded that “an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works.”Dr. Rind added that “while awaiting proof, we believe that patients would benefit from a price closer to the price of production of Relyvrio rather than a price more than five times higher than the top of a value-based range.”During an investor conference call on Friday, Justin Klee, a founder of Amylyx, said the price was chosen after meeting with insurers, patients, doctors and others. He said the company considered what would allow it to “invest in new treatments so that A.L.S. first becomes a manageable chronic condition and ultimately is cured,” and added that the price “allows Amylyx to sustain programs to help people who can benefit from Relyvrio access it.”The F.D.A. has approved only two other A.L.S. medications. Riluzole, a tablet approved in 1995, can extend survival by several months and generally costs significantly less than $10,000 a year. Edaravone, marketed as Radicava, can slow symptom progression by about 33 percent. Radicava, which was originally approved in 2017 as an intravenous infusion, was approved this year in an oral form that carries a list price of $171,000 a year. Amylyx officials said they expected that, as in the company’s clinical trials, many patients would take Relyvrio, a powder that is mixed with water, along with one or both of the other medications.Relyvrio was conceived by the founders of Amylyx, Mr. Klee and Joshua Cohen, when they were undergraduate students at Brown University less than a decade ago. They proposed that combining taurursodiol, an over-the-counter supplement sometimes used to regulate liver enzymes, and sodium phenylbutyrate, a prescription medication for a pediatric urea disorder, could protect neurons in the brain from damage in diseases like A.L.S. by preventing dysfunction of two structures in cells: mitochondria and the endoplasmic reticulum.In an interview, Mr. Klee said the company expected that private insurers would cover the drug with no co-payments for patients, and he said that Amylyx would work to make it affordable for people on Medicare or Medicaid and provide it free to those without insurance who are financially struggling. Mr. Klee noted that patients had been obtaining the ingredients on their own for some time, buying the taurursodiol supplement from Amazon and paying up to $11,000 a month for the sodium phenylbutyrate.“Now that our product is approved, we have to be laser-focused on making sure that people can access it,” Mr. Klee said.Relyvrio’s clinical trials included patients who developed symptoms of A.L.S. within 18 months before the trial and were affected in at least three body regions, which is generally a sign of fast-progressing disease. The F.D.A.’s approval did not restrict which patients could use the medication. Mr. Cohen said in an interview that Amylyx didn’t have projections of how many would.“There are patients who are just receiving the diagnosis today, and there are patients who are making end-of-life decisions today, and I think that people in different circumstances are going to make very different treatment decisions,” he said.Amylyx has also conducted a small trial of Relyvrio in Alzheimer’s patients, and Mr. Cohen discussed plans to test it for other neurodevelopmental disorders.“We conceived the drug to try to target pathways of neuronal death,” he said, “and neuronal death is an important part of not just A.L.S. but potentially many diseases.”