Long Covid Patients More Likely to Have Gastrointestinal Problems, Study Finds

The study, which examined patients infected early in the pandemic, found they were significantly more likely than people who didn’t get Covid to experience lingering reflux, constipation and other issues.Stomach pain, constipation, diarrhea, vomiting, bloating — these are symptoms frequently reported by people with long Covid. Now, a large new study reports that Covid patients were significantly more likely to experience gastrointestinal problems a year after infection than people who were not infected. The study, published on Tuesday in the journal Nature Communications, compared medical records of 154,068 Covid patients in the Veterans Health Administration system with about 5.6 million patients of similar age and other characteristics who had not contracted the coronavirus. Covid patients were 36 percent more likely to have long-term gastrointestinal problems that they did not have before their infection, with 9,605 of them experiencing issues affecting the digestive system, intestines, pancreas or liver.The most common diagnoses were acid-related disorders, like gastroesophageal reflux disease (known as GERD) and peptic ulcer disease, which were identified in more than 2,600 patients. “There seems to be some dysregulation that points to a major imbalance in acid production,” said the senior author of the study, Dr. Ziyad Al-Aly, chief of research and development at the V.A. St. Louis Health Care System and a clinical epidemiologist at Washington University in St. Louis.More on the Coronavirus PandemicLab Leak: New intelligence has prompted the Energy Department to conclude that an accidental laboratory leak in China most likely caused the pandemic, though U.S. spy agencies remain divided over Covid’s origins.New Drug’s Long Odds: A promising new treatment quashes all Covid variants, but regulatory hurdles and a lack of funding make it unlikely to reach the United States market anytime soon.Dangers Remain for Seniors: For older Americans, the Covid pandemic still poses significant threats. But they are increasingly left to protect themselves as the rest of the country abandons precautions.N.Y.C.’s Mandate: New York City will end its aggressive but contentious vaccine mandate for municipal workers, Mayor Eric Adams announced, signaling a key moment in the city’s long battle against the pandemic.Serious inflammatory illnesses — like acute pancreatitis and cholangitis, which is inflammation of the bile duct system — affected a much smaller percentage of patients, but they were nonetheless more common among those who had Covid than those who had not.“With all of these disorders there is an increased odds ratio, meaning that the people who had Covid and survived for 30 days or longer were more at risk of each of these categories,” said Dr. Saurabh Mehandru, a professor of gastroenterology at the Icahn School of Medicine at Mount Sinai in New York who was not involved in the study.Long Covid patients were also at higher risk of gastrointestinal symptoms, the most common being constipation, abdominal pain and diarrheaACE2, the receptor for SARS-CoV-2 (the virus that causes Covid-19), is shown in green, with intestinal epithelial cells in red and cell nuclei in blue. As shown, ACE2 covers a large surface of the small intestinal epithelium.Minami Tokuyama//MehandruLab at the Icahn School of Medicine at Mount SinaiThe study, like others drawing on the database of veterans, involves a patient population that is largely white and male with an average age of about 61. Still, the same patterns were seen among the study’s 37,000 post-Covid Black patients and nearly 17,000 post-Covid female patients, Dr. Al-Aly said.The patients became infected during the pandemic’s early waves, testing positive for the coronavirus between March 1, 2020, and Jan. 15, 2021, the overwhelming majority before vaccines were available. Dr. Al-Aly and Dr. Mehandru noted that the experience might be different for people infected more recently. Newer virus variants might have different effects, they said, and some research suggests that vaccines can reduce the risk of various long Covid symptoms. There are several reasons coronavirus infections may fuel long-term gastrointestinal problems. Dr. Mehandru, who has studied some possible causes, said his team and others had found that a protein the virus attaches to on some cell surfaces, called the ACE2 receptor, was abundant in the lining of the small intestine. Those receptors might provide a way for the virus to directly enter the digestive system, he said. It’s also possible that some viral fragments remained after infections resolved, keeping patients’ immune systems activated and generating inflammation-related symptoms.Another possibility is the “gut-brain connection,” said Dr. Mehandru, explaining that “when we’re stressed we have intestinal manifestations.” And, he added, “some of the symptoms could also be because of a generalized state of being unwell or having illness outside of the intestines, which could impact how we move our bowels or mean that we feel bloated or have acid reflux.”Dr. Al-Aly said most long Covid patients had other symptoms besides gastrointestinal problems, suggesting that the condition was “too complex to have just one mechanism that explains all of it.”The new study did not identify whether certain previous health conditions, like diabetes or cardiovascular disease, put people at greater risk of post-Covid gastrointestinal problems. Like many other long Covid studies, it did find that people whose initial infections were severe enough to warrant intensive care or other hospitalization were more prone to long-term symptoms. Still, people with mild initial infections — who make up a majority of Covid patients — were nonetheless at greater risk than people who were not infected.Underscoring the significance of post-Covid symptoms, the study found that long Covid patients were at greater risk of gastrointestinal problems than nearly six million people in the veterans database before the pandemic. It also found that people hospitalized with a coronavirus infection were more likely to develop long-term gastrointestinal issues than people hospitalized with the flu.Dr. Al-Aly did sound one note of optimism. While some symptoms of long Covid, like fatigue and brain fog, can be intractable for months despite different therapies, many gastrointestinal symptoms are treatable. “Obviously, there’s no one treatment for all of this,” he said. “But I think these are diagnoses and signs and symptoms that could be managed.”

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Walgreens Says It Won’t Offer the Abortion Pill Mifepristone in Conservative States

The decision applies to 21 states whose attorneys general threatened Walgreens and other pharmacies with legal action if they dispensed the pill there.A few weeks after Republican attorneys general in 21 states sent letters threatening legal action against retail pharmacy chains if they dispensed the abortion pill mifepristone, Walgreens said it would not distribute the pill in those states.In January, after the Food and Drug Administration said it would allow retail pharmacies to become certified to dispense mifepristone — the tightly regulated medication that is the first pill in the two-drug medication abortion regimen — Walgreens, CVS and other pharmacies said they planned to do so in states where abortion was legal. The American Pharmacists Association said that pharmacies would be very cautious about dispensing in any state where they might risk losing their license or face other penalties.The decision this week by Walgreens reflects that caution. In four of the states — Alaska, Iowa, Kansas and Montana — abortion is technically still legal, but there are efforts to restrict it that would apply to abortion pills.“This is a very complex and in flux area of the law, and we are taking that into account as we seek certification,” said a spokesman for Walgreens, Fraser Engerman.He said that Walgreens told 20 attorneys general, who had jointly signed one letter, and the attorney general of Kansas, who sent a separate letter, that it would not be distributing mifepristone in their states.The decision does not affect the second pill in the medication abortion regimen, misoprostol, which is used for several medical conditions and has long been available by prescription at retail pharmacies nationwide.A spokesman for CVS did not immediately respond to a question about whether the company had also decided not to dispense mifepristone in those 21 states, but in January, a spokeswoman said, “We plan to seek certification to dispense mifepristone where legally permissible.”Politico reported the Walgreens decision on Thursday night. The chain’s decision not to dispense pills in Kansas was announced last month.

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12 States Sue F.D.A., Seeking Removal of Special Restrictions on Abortion Pill

The suit argues that rules applying to mifepristone unnecessarily limit patients’ access to medication abortion.The attorneys general of a dozen Democratic-controlled states sued the Food and Drug Administration on Friday, asking a judge to remove special restrictions that the federal agency has long applied to the first of two drugs used in medication abortion.The suit, filed in a Federal District Court in Washington State, comes at a tense moment in the battle over the legal status of abortion pills, which are used in more than half of abortions in the United States. A federal judge in Texas is expected to issue an order soon in a case filed by anti-abortion groups that seeks to overturn the F.D.A.’s approval of the same abortion pill, mifepristone, and have it taken off the market.The potential consequences of the Texas case have set the reproductive health community on edge out of concern that the judge, a Trump appointee who is politically conservative and wrote an article that was critical of Roe v. Wade, could issue an order effectively blocking access to mifepristone across the country. Such a ruling would immediately be appealed, but if it ultimately stands, it would have far-reaching implications, affecting states where abortion is legal, not just states where abortion is already restricted.The new lawsuit filed by the 12 states does not address the possible outcomes of the Texas case, but it requests that the judge’s ruling in the Washington case include orders that would effectively contravene steps that might be imposed by the Texas judge. While the Washington case primarily asks the court to order the F.D.A. to eliminate a framework of extra restrictions applied to mifepristone, the suit also asks the judge to declare that the F.D.A.’s “approval of mifepristone is lawful and valid” and to enjoin the F.D.A. “from taking any action to remove mifepristone from the market or reduce its availability.”Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School, said the timing and content of the lawsuit were strategic.“It is a legally and politically savvy move to file this complaint now,” he said. “If you have a federal judge in one jurisdiction saying the approval was lawful, and actually enjoining F.D.A. from taking action to restrict access, that would stand in exact conflict with what many presume the Texas judge may do, which is actually rescind the approval of the drug.”If two federal rulings were to conflict, said Dr. Sarpatwari, an expert on F.D.A. regulations, “that gives ground for the federal government to say, ‘Look, I’ve got two courts saying two fundamentally different things, and the best we can do right now is to not do anything.” That could result in both cases landing before the Supreme Court and in preserved access to mifepristone until a high court decision, he said.Kristin Beneski, first assistant attorney general for Washington State, said the goal of the new lawsuit “is to protect and expand access to medication abortion.”She added, “It’s not right for one judge in Texas to decide for all Americans whether they can access the gold standard of care for early pregnancy termination.”The F.D.A. declined to comment on the new case, saying it does not discuss pending litigation.In the Texas lawsuit, anti-abortion groups claim that the F.D.A. improperly approved mifepristone and ignored safety risks. In a filing in that case, the F.D.A. disputed those claims and said that revoking its drug approval would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”The filing on Friday was led by the attorneys general of Washington and Oregon, who were joined by their counterparts in Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont. The suit takes aim at a special framework of restrictions and monitoring that the F.D.A. currently applies to only about 60 drugs. Called a Risk Evaluation and Mitigation Strategy, or REMS, it has applied to mifepristone for about a dozen years.Initially, it was considerably more restrictive than it is now, with rules requiring that patients obtain mifepristone in person from a health care provider, although they could take the drug on their own at home or anywhere they chose.In recent years, the F.D.A. has extensively reviewed new data on mifepristone and lifted several of the restrictions, including the in-person requirement. It now allows the drug to be sent to patients by mail and recently authorized retail pharmacies to dispense the medication if they become specially certified.The agency’s remaining special requirements for mifepristone are that patients sign an agreement attesting that they have chosen to take the medication to terminate a pregnancy. Providers and pharmacies must become certified, which is not difficult but involves certain administrative and logistical steps.Ms. Beneski said the certification requirements and the agreement that patients must sign are burdensome, project an erroneous sense that the medication is unsafe and have deterred many providers who would otherwise prescribe mifepristone, limiting access to medication abortion. The requirements, which generate lists of certified providers, also make providers worry about their privacy in a political environment where, she said, “they are really concerned about being targets of violence and harassment.”“We are not arguing that the F.D.A. should not have approval authority over mifepristone, only that the REMS system is unnecessary for this drug and poses unnecessary risks to providers and patient in the current legal landscape,” Ms. Beneski said. “Those risks are real, and need to be addressed.”Mifepristone is also used for treatment of miscarriage, and the F.D.A. restrictions also apply for those patients, who must attest when signing the agreement that they have “decided” to end their pregnancy, the lawsuit says.While abortion opponents assert that medication abortion has serious safety risks, mainstream medical organizations and abortion rights groups have long said that special restrictions on mifepristone are unnecessary, citing years of data on safety and efficacy. But, in an unusual twist, since the Supreme Court decision overturning Roe v. Wade, some reproductive health legal experts have argued that officially keeping the REMS framework in place is beneficial in fighting against state laws that aim to ban or restrict abortion.Their argument is that the F.D.A.’s decision to apply special restrictions to mifepristone, and to gradually ease some of them as evidence of safety and efficacy has grown, shows how careful and rigorous the federal government has been with the drug and strengthens the case that the F.D.A. has ultimate authority over states. That argument was made recently in two lawsuits that challenge the constitutionality of state abortion bans and restrictions — one filed in West Virginia by a mifepristone manufacturer and the other in North Carolina by an obstetrician-gynecologist.On Friday, though, several of those experts said they supported the new lawsuit’s effort to lift the extra restrictions. David S. Cohen, a law professor at Drexel University, said that while lawsuits claiming that F.D.A. regulations pre-empt state laws “are ironically helped by these restrictions,” the cases do not need those restrictions to succeed.Dr. Cohen called the new lawsuit a “great strategy,” adding that “removing the needless restrictions the F.D.A. has imposed on the drug — restrictions not backed by any science — is one of the highest priorities.”

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Helping Stroke Patients Regain Movement in Their Hands

Heather Rendulic was 23 when she suffered a stroke that disabled her left side. Ten years later, her left arm and hand remain so impaired that she cannot tie her shoes, type with two hands or cut her own food.But for an extraordinary month, while participating in an innovative study, she suddenly was able to open a padlock with a key, draw a map of Italy, dip a chicken nugget in sauce and eat it with a fork — all with that left hand.“It was like I actually had two arms, oh my gosh!” Ms. Rendulic said recently.Researchers from the University of Pittsburgh and Carnegie Mellon University implanted electrodes along her spinal cord , delivering electrical stimulation while she tried different activities. With stimulation, her left arm had greater mobility, her fingers had more dexterity, and she could make intentional movements more quickly and fluidly.The study, published Monday in the journal Nature Medicine, represents the first successful demonstration of spinal cord stimulation to address weakness and paralysis in the arms and hands of stroke patients.The study was small and preliminary, involving only Ms. Rendulic and another patient. Several scientists said many questions remain about the technique’s effectiveness and applicability, but that the research suggested spinal cord stimulation could eventually help some of the many people who experience strokes.“I think there’s enormous implications for improving quality of life,” said Dr. Lumy Sawaki-Adams, the program director in the clinical research division of the National Institute of Neurological Disorders and Stroke, who was not involved in the research. Still, she said, “we have to be cautious that we’re not offering hope to many people when I think we’re not there yet.”Spinal cord stimulation has been used for decades to treat chronic pain. More recently, experiments delivering stimulation — either through surgically implanted electrodes or noninvasively through electrodes placed on the skin — have shown promise in helping patients with spinal cord injuries regain mobility in their legs and, in some cases, their arms and hands.But the approach has been mostly unexplored for stroke, partly because of differences in the location and type of damage, neurological experts said.Because strokes occur in the brain, it had been assumed that applying stimulation outside the brain would not provide “the same bang for the buck,” said Arun Jayaraman, the executive director of the technology and innovation hub at Shirley Ryan AbilityLab, a rehabilitation center in Chicago. He said the study, which he was not involved in, countered that assumption, instead suggesting that stimulating the spine, the pathway from the brain to hand and arm muscles, may help impaired limbs.Over four weeks, Ms. Rendulic was given increasingly challenging tasks to perform, like grasping and moving a soup can. “I immediately was opening and closing my hand,” she said. “We all broke down in tears.”Powell et al., University of Pittsburgh and Carnegie Mellon UniversityEach year, more than 12 million people worldwide and nearly 800,000 in the United States experience strokes, said Dr. Karen Furie, the vice chair of the American Stroke Association’s stroke brain health science subcommittee.Initially, patients typically receive about six months of physical, occupational and other therapies, she said, but then progress often plateaus.“We have virtually nothing to offer people who are years out and have longstanding disabilities,” said Dr. Furie, who is also the chair of neurology at Brown University’s Warren Alpert Medical School and was not involved in the study.About three-quarters of stroke patients experience impairment, weakness or paralysis in their arms and hands, said Dr. Elliot Roth, an attending physician at Shirley Ryan AbilityLab’s Brain Innovation Center, who was not involved in the study. “For many people, it’s the toughest part of the stroke recovery process and tends to recover the slowest,” he said.The patients who participated in the study had experienced different types of strokes and had varying degrees of impairment. Ms. Rendulic’s stroke was hemorrhagic, caused by bursting blood vessels. The other, more severely impaired patient, a 47-year-old woman whom researchers did not identify, experienced an ischemic stroke, which is more common and involves blocked blood vessels.Researchers implanted strands of eight electrodes in two locations, corresponding to where neurosensory fibers from the arm and the hand enter the spinal cord.Marco Capogrosso, an assistant professor of neurological surgery at the University of Pittsburgh, said that the approach derived from the fact that with strokes, some neural areas remain undamaged.“So, if we can build this technology to amplify neural signals, maybe we have a chance to restore arm and hand movement,” said Dr. Capogrosso, who led the research with Elvira Pirondini, an assistant professor of physical medicine and rehabilitation at the University of Pittsburgh, and Douglas Weber, a professor of mechanical engineering at Carnegie Mellon’s Neuroscience Institute.Five days a week for four hours each day, researchers activated the stimulation, calibrated it to determine optimal parameters for each patient and asked them to attempt various movements and tasks. Right away, the effect was noticeable.“The very first day in the lab and the first time they turned it on, I was sitting in a chair, and they asked me to open and close my hand, and that’s something that’s really difficult for me,” Ms. Rendulic said. As her husband and mother watched, “I immediately was opening and closing my hand,” she said. “We all broke down in tears.”Ms. Rendulic said she would welcome another opportunity to have spinal cord stimulation. “I did threaten to not show up to the surgery to get it removed,” she said. “I just wanted it all the time.”Kristian Thacker for The New York TimesOver four weeks, she was given increasingly challenging tasks, like gripping and moving a soup can. With stimulation, her left hand moved 14 small blocks over a barrier in a box, compared with six blocks without stimulation.Typically, when Ms. Rendulic, 33, who works at home for a company’s human resources department, tries to make her left hand do something like grasp a pen, her arm feels like “it’s made of rock,” almost disconnected from her brain, she said. With stimulation “it was like my brain was able to find my left arm so much easier.”The other patient, who was given simpler tasks because her left hand was almost completely paralyzed, improved in skills like reaching.Researchers also tested a “sham” stimulation, activating electrodes randomly to see if patients responded to a kind of placebo effect rather than stimulation targeted specifically to their arms and hands. Both performed better with targeted stimulation.The patients sensed the stimulation, but it didn’t cause pain, rigidity or safety problems, researchers reported.The approved study protocol required removing the electrodes after 29 days. But one month later, the patients retained some improved abilities, surprising researchers. “We thought it was not possible” after only four weeks of stimulation, Dr. Pirondini said.It is unclear exactly why the benefit can persist, Dr. Capogrosso said, but he hypothesized that “the same neural processes that allow these people to use this stimulation method also lead to a recovery of movement when the stimulation is off.” He added, “we’re not creating new fibers, but we’re definitely restrengthening what there is.”Several experts noted that this pilot study was not designed to answer the most relevant question for patients: Can the improvements in laboratory tasks translate into skills that matter in daily life?“It’s a first step among hundreds,” said Dr. Daniel Lu, a professor and vice chairman of neurosurgery at the University of California Los Angeles, who co-authored a 2016 study that showed that spinal stimulation from implanted electrodes improved hand strength and control in two spinal cord injury patients.Dr. Lu said he believes stimulation is promising, but that its impact in the new study was difficult to evaluate because there was no comparison group and patients were not given the same regimen of intensive activities before stimulation — activities that might themselves have therapeutic benefit.“Is it possible that you’re just exercising the patient, and the patient without the stimulation would have gotten the same effect?” he asked.While Ms. Rendulic has devised ways to do activities like driving and typing with only her right hand, everyday frustrations rankle. But, “In the trial, I did get to cut up a steak, which was awesome,” she said.Powell et al., University of Pittsburgh and Carnegie Mellon UniversityAnother question neuroscientists raise is whether — or in what circumstances — it is better to surgically implant electrodes or place them on the skin, a less expensive method called transcutaneous stimulation. The new study’s authors consider surgical implantation superior because it is “much more specific,” said Dr. Weber, allowing it to “target the muscles that control the wrist and the hand.”Others, like Chet Moritz, a professor of neurotechnology at the University of Washington, have reported improvements in spinal cord injury patients using electrodes on the skin, including benefits lasting months after stimulation ends. “It’s true we can’t tune the shoulder to this degree and the elbow to this degree and the wrist to that degree, but the nervous system seems to take care of that for us,” he said.Several neurological experts predicted that both methods could eventually be helpful and appropriate for different patients, depending on their health and other factors. All the experts, including the study authors, said stimulation would be more effective if accompanied by rehabilitation therapies.The study’s authors said their continuing research is evaluating patients of varying stroke severity, age and other characteristics to determine who would benefit from their approach. They have formed a company and said they envision that, as with similar technology for chronic pain, patients could adjust their stimulation via app or remote control.If stimulation becomes regularly available to stroke patients, Ms. Rendulic would welcome it. “I did threaten to not show up to the surgery to get it removed,” she said. “I just wanted it all the time.”While she has devised one-handed ways to do activities like driving and typing, everyday frustrations rankle, like needing her husband Mark, whom she calls “my left-hand man,” to slice steak for her.“In the trial, I did get to cut up a steak, which was awesome,” she said. Then, fork in her left hand, she speared a piece and lifted it to her mouth — one previously impossible movement at a time.

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New Lawsuit Challenges State Bans on Abortion Pills

The case, brought by GenBioPro, a company that makes one of two abortion drugs, argues that it is unconstitutional for a state to bar access to a medication approved by the federal government.A company that makes an abortion pill filed a lawsuit Wednesday morning challenging the constitutionality of a state ban on the medication, the first in what is expected to be a wave of cases arguing that the federal Food and Drug Administration’s approval of the pill takes precedence over such restrictive state laws.The case was filed in federal court in West Virginia by GenBioPro, one of two American manufacturers of mifepristone, the first pill used in the two-drug medication abortion regimen. A ruling in favor of the company could compel other states that have banned abortion to allow the pills to be prescribed, dispensed and sold, according to legal experts. If the courts reject the company’s arguments, some legal scholars say the decision could open the door for states to ban or restrict other approved drugs, such as Covid vaccines or morning-after pills.The case is one of a number of lawsuits testing legal arguments in the aftermath of the Supreme Court’s ruling last June overturning the federal right to abortion. In November, abortion opponents filed a lawsuit challenging the F.D.A.’s approval of mifepristone nearly 23 years ago and asked that the courts order the agency to stop allowing the use of the drug and the second drug, misoprostol, for abortion.Taken together, the cases underscore how pivotal medication abortion has become in legal and political battles. With pills now being used in more than half of abortions in America, and with recent F.D.A. decisions allowing patients to have pills prescribed by telemedicine and obtained by mail or from retail pharmacies, states that ban or restrict abortion are increasingly targeting the medication method.The dueling lawsuits are a reflection of what several legal scholars predicted in a recent article: that the aftermath of the Supreme Court’s decision would be “a complicated world of novel interjurisdictional legal conflicts over abortion.” The authors — David S. Cohen, Greer Donley and Rachel RebouchĂ©, all law professors — wrote that “instead of creating stability and certainty, it will lead to profound confusion because advocates on both sides of the abortion controversy will not stop at state borders in their efforts to apply their policies as broadly as possible.” Recent articles by legal scholars and experts on drug and medical policy have made the case that the federal government has overarching authority to approve and regulate medications, a question only a few previous legal cases have tested.Members of the public watched as the West Virginia Senate discussed an abortion bill in July. Associated PressThese experts say states are allowed to adopt some laws and regulations that supplement federal rules on drugs and to regulate the practice of medicine within their jurisdiction. But they say states cannot impose policies that interfere with or contradict F.D.A. standards or requirements, so they cannot ban or drastically restrict a medication the federal government has approved.“Under the U.S. Constitution, federal law preempts state law when the two clash,” Patricia Zettler, a law professor, and Ameet Sarpatwari, a professor of medicine, wrote in an article in The New England Journal of Medicine last year. Scholars cite a 2014 Massachusetts case in which the state sought to ban a new opioid, Zohydro ER, because it worried that the drug could be abused and lead to addiction or overdose. A federal judge sided with the drug company, Zogenix. If the state “were able to countermand the F.D.A.’s determinations and substitute its own requirements, it would undermine the F.D.A.’s ability to make drugs available to promote and protect the public health,” the judge wrote. Subsequent efforts by Massachusetts to restrict Zohydro were also rejected by the courts.Skye Perryman, a lawyer for GenBioPro and president of Democracy Forward, a center-left legal advocacy organization, said West Virginia’s ban was “an overreach of state authority when a state tries to step in the shoes of F.D.A. and to make safety and efficacy determinations that conflict with and interfere with F.D.A.’s judgments.”West Virginia adopted an abortion ban in September. The suit contends that the ban violates the Constitution’s supremacy clause, which says that federal laws — in this case, Congress’s decision to authorize the F.D.A. to regulate drugs like mifepristone — have priority over conflicting state laws. The suit also says such bans violate the Constitution’s commerce clause, which prohibits states from impairing interstate commerce.GenBioPro, which started making generic mifepristone in 2019, said in the suit that because of West Virginia’s ban and previously enacted abortion restrictions, it had been able to ship only 72 units of mifepristone to be used in the state and that by August 2022, its sales had dropped to zero there. GenBioPro said its sales had dropped to nothing in seven other states with abortion bans and in Wisconsin, where abortion services have stopped operating in light of unclear laws.Dr. DeShawn Taylor, GenBioPro’s medical director, said that bans “deprive people of the ability to access safe and effective medications and it also jeopardizes our company.” She added, “If people don’t have access to mifepristone, then of course, it impacts the company’s bottom line.” Dr. Taylor, an obstetrician-gynecologist who owns a family planning clinic in Arizona, also noted that mifepristone is frequently used in treating patients who are experiencing miscarriages.A notable aspect of the F.D.A.’s regulation of mifepristone is that for a dozen years, the agency has imposed an additional framework of restrictions and monitoring for the drug. Called a Risk Evaluation and Mitigation Strategy, or REMS, it has been used for only about 300 other drugs, only 60 of which are currently actively under the framework. In recent years, the F.D.A. has extensively reviewed new data on mifepristone and has lifted several of the restrictions, including the requirement that patients obtain the drug in person from a provider.Some legal experts say the F.D.A.’s decision to apply special restrictions to mifepristone, and to gradually ease some of them as evidence of safety and efficacy has grown, strengthens the case for striking down state bans and restrictions and affirms that the federal government is the ultimate authority on the drug.“A strong case can be made that state-required measures that go beyond the conditions” set by the F.D.A.’s restrictions on mifepristone “upset the complex balancing of safety and burdens on the health care system that federal law requires of the F.D.A.,” The New England Journal of Medicine article said.The Texas case filed by opponents of abortion seeks to reverse more than 20 years of federal decisions about medication abortion, claiming that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000.The case was filed by the Alliance for Hippocratic Medicine — an organization that lists five anti-abortion groups as its members — in Amarillo, Texas, where it was assigned to the only judge in the Northern District of Texas, Matthew Kacsmaryk. Before his appointment, Judge Kacsmaryk, a Trump appointee, wrote an article that was critical of Roe v. Wade, as well as issues like marriage equality and federal anti-discrimination protections for sexual orientation and gender identity.Dr. Christina Francis, the chief executive officer of the American Association of Pro-Life Obstetricians and Gynecologists, a group that belongs to the alliance, said that the F.D.A., in its initial approval and its recent decisions to ease some restrictions on mifepristone, had “reviewed a handful of cherry-picked studies that don’t actually look at the full picture.” She added that agency officials were “actively endangering the lives of women and girls in the country, especially as they continue to remove safeguard after safeguard.”Most medical organizations say that extensive data shows the opposite: that with mifepristone, the F.D.A. has been considerably more restrictive than necessary and that allowing it to be prescribed via telemedicine and received in the mail were changes that were long overdue.Indeed, two citizen petitions opposing the F.D.A.’s actions on mifepristone, filed in 2002 and 2019 by some of the same anti-abortion organizations, were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities with the F.D.A.’s mifepristone approval.Because of the scientific evidence and rigor of the F.D.A.’s handling of mifepristone, many experts on reproductive health law said they had initially viewed the Texas case as so baseless that it would have no chance at succeeding. But some are starting to worry.“This should have been a fringe lawsuit, and it should have been tossed out very quickly,” said Jenny Ma, senior counsel for the Center for Reproductive Rights. But she said that now, supporters of abortion rights are worried that the case is before a judge whose writings and decisions reflect a resolutely conservative ideology.“A single district court judge in Texas, which is a state that already has banned all abortion, could be issuing a nationwide ban on medication abortion, which now accounts for more than half of abortions in the United States, and obviously, the effects would be devastating,” Ms. Ma said.Erik Baptist, senior counsel for the Alliance Defending Freedom, a conservative Christian legal advocacy group, which represents the plaintiffs, expressed confidence in the case. “A court will look at what the F.D.A. was legally required to do when evaluating the safety and effectiveness of a new drug — here, chemical abortion drugs — and it will probably take a different viewpoint than the F.D.A., in terms of reviewing the prior agency actions.”In a response to the case filed this month, the F.D.A. called the case “unprecedented” and said that if the judge granted the plaintiffs’ request for an injunction that stopped access to mifepristone, it would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”

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Long Covid Is Keeping Significant Numbers of People Out of Work, Study Finds

An analysis of workers’ compensation claims in New York found that 71 percent of claimants with long Covid needed continuing medical treatment or were unable to work for six months or more.Long Covid is having a significant effect on America’s work force, preventing substantial numbers of people from going back to work while others continue needing medical care long after returning to their jobs, according to a new analysis of workers’ compensation claims in New York State.The study, published Tuesday by New York’s largest workers’ compensation insurer, found that during the first two years of the pandemic, about 71 percent of people the fund classified as experiencing long Covid either required continuing medical treatment or were unable to work for six months or more. More than a year after contracting the coronavirus, 18 percent of long Covid patients had still not returned to work, more than three-fourths of them younger than 60, the analysis found.“Long Covid has harmed the work force,” said the report, by the New York State Insurance Fund, a state agency financed by employer-paid premiums. The findings, it added, “highlight long Covid as an underappreciated yet important reason for the many unfilled jobs and declining labor participation rate in the economy, and they presage a possible reduction in productivity as employers feel the strains of an increasingly sick work force.”The report, which analyzed Covid-related claims from patients exposed to the virus at work, filed between Jan. 1, 2020, and March 31, 2022, and paid by the agency, provides a snapshot of the problem. The agency, one of the 10 largest workers’ compensation insurers in the country, found that nearly a third of 3,139 Covid-related claims it paid met its definition of long Covid.Patients received coverage from the fund if they had a positive coronavirus test and the agency or a workers’ compensation board determined that they had a high risk of having been exposed to the virus while at work, typically in environments like hospitals, grocery stores or transit systems. The report classified a case as long Covid if, after infection, a patient required medical treatment for 60 days or more or lost 60 or more days of work.More on the Coronavirus PandemicAnnual Boosters: The Food and Drug Administration proposed that most Americans be offered a single dose of a Covid vaccine each fall, much as they are given flu shots.A Better Covid Winter: Some of the worst days of Covid in the United States have come as winters have settled in. But a surge in hospitalizations has yet to materialize this season.New Subvariant: A highly contagious version of the Omicron variant — known officially as XBB.1.5 or by its subvariant nickname, Kraken — is quickly spreading in the United States.Pfizer’s Boosters: Federal officials said that fears that the Covid booster shots made by Pfizer may increase the risk of strokes in people aged 65 and older were not borne out by an intensive scientific investigation.“It’s a pretty conservative estimate,” said Gaurav Vasisht, executive director and chief executive officer of the insurance fund. “It’s not capturing people who may have gone back to work and didn’t seek medical attention and may still be suffering, so you know, they’re just toughing it out.”During the time frame of the report, claims for the 977 people the fund designated as having long Covid cost about $17 million out of the approximately $20 million paid to all Covid patients, officials said, adding that the proportion for lost wages was slightly greater than for medical treatment. But Mr. Vasisht cautioned that the dollar amounts provided only a partial picture because it was unclear how long people would need medical care or time off for long Covid.He added that the cost to patients went beyond money. “The longer you’re out of work, the harder it is for you to get back to work, and that can stigmatize patients,” Mr. Vasisht said. “It could be highly disruptive to their family and professional lives.”Long Covid is defined by public health authorities as a constellation of symptoms that linger after the initial infection or that emerge weeks later and can include breathing problems, fatigue and brain fog. The Government Accountability Office estimated that long Covid has affected 7.7 million to 23 million people in the United States.A long Covid patient returned to part-time work after being diagnosed in 2021.Alex Wroblewski for The New York TimesKatie Bach, a nonresident senior fellow at the Brookings Institution who was not involved in the report, said the study showed that “we have a group of people who got long Covid and at least up until now have been unable to get back to work, and it is a nontrivial number of people.”She said the report reflects only a slice of the work force: employees with workplace exposure to the virus who are knowledgeable enough about workers’ compensation to file claims. It might include employees who are younger or sicker than the overall working population, while also missing other workers with long Covid, said Ms. Bach, whose own research suggests that about 500,000 people in the United States are currently not working because of long Covid.The New York report also found some optimistic signals. Since the pandemic’s first wave in early 2020, long Covid cases decreased as a percentage of workers’ compensations claims and of Covid-related claims. The decrease coincided with the advent of vaccines, which studies suggest reduce the risk of long Covid, and with new coronavirus treatments, supporting the idea that if people can avoid becoming severely ill from their initial infection, they are less likely to experience long-term symptoms.Still, Mr. Vasisht said the agency continued to receive claims for workers with long Covid, especially after surges in infections. The report also suggested that more employees than reflected in the data might have met the criteria for long Covid claims. The vast majority of all Covid-related claims, over 83 percent, were filed by essential workers — in occupations like health care, law enforcement and security services. But only 29 percent of their claims met the definition for long Covid, while 44 percent of nonessential workers met that definition.That could be because “essential workers might not have been able to stay home from work beyond the required quarantine period,” the report said. And health care workers might have “self-treated their symptoms” rather than seeking medical care, the report said, adding “essential workers may have long Covid rates higher than the data suggests, creating a blind spot for policymakers.”“A lot of people can’t afford to not work and so they’re working when they really shouldn’t be, continuing to work while they’re sick,” said Ms. Bach. She said that the experience of people with similar post-viral conditions like myalgic encephalomyelitis and chronic fatigue syndrome suggests that some people who work despite their long Covid may have harder recoveries. “When people who have a condition whose hallmark symptoms are fatigue and brain fog go into work, they’re not going to be as productive and they’re probably reducing their odds of improvement,” she said.And because 40 percent of claimants with long Covid returned to work within 60 days of becoming infected while still receiving medical treatment, Mr. Vasisht said employers might receive “more requests for reduced hours or other accommodations.”The study also found that doctors only used a specific long Covid diagnostic code in 30 cases, even though the code was added to the International Classification of Diseases in October 2021. “Physicians are underutilizing the I.C.D. code,” said Mr. Vasisht, adding that he believed his organization “can do a lot of good by conducting outreach to the physician community and letting them know about the research on long Covid and also about the existence of this I.C.D. code.”Other findings were consistent with previously identified long Covid patterns, including results of two 2022 studies that analyzed different workers’ compensation data sets. The most common long Covid symptoms included shortness of breath, fatigue, weakness, and cognitive and memory problems.Women appeared to be at greater risk than men, as were people who became sick enough from their initial infection to be hospitalized and those with previous conditions like lung disease, hypertension, obesity and depression. Adults older than 60 were less likely to resume working than younger employees, which might indicate that some long Covid patients are retiring early, adding to labor shortages, Ms. Bach said.Overall, said David Cutler, an economics professor at Harvard who has researched the cost of long Covid and was not involved in the study, “The report shows that even if Covid deaths are down, Covid is not over, and it won’t be for some time.”

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The Father of the Abortion Pill

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-BicĂȘtre 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 GĂ©rard 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. LĂ©on 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, ThĂ©rĂšse 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, LĂ©on Blum, a kidney specialist, and his mother, ThĂ©rĂšse 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-BicĂȘtre 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. JĂ©rĂŽme 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 AubĂ©ny, 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 GrĂ©gory 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

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FDA Approves New Treatment for Early Alzheimer’s

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.

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CVS and Walgreens Plan to Offer Abortion Pills Where Abortion Is Legal

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.

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Abortion Pills Can Now Be Offered at Retail Pharmacies, F.D.A. Says

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.”

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