Texas Judge Invalidates FDA Approval of the Abortion Pill Mifepristone

The Texas judge’s ruling was quickly contradicted by another federal judge in Washington State who ordered the F.D.A. to keep mifepristone available.A federal judge in Texas issued a preliminary ruling invalidating the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, an unprecedented order that — if it stands through court challenges — could make it harder for patients to get abortions in states where abortion is legal, not just in those trying to restrict it.The drug will continue to be available at least in the short-term since the judge, Matthew J. Kacsmaryk, stayed his own order for seven days to give the F.D.A. time to ask an appeals court to intervene.Less than an hour after Judge Kacsmaryk’s ruling, a judge in Washington state issued a ruling in another case, which contradicted the Texas decision, ordering the F.D.A. to make no changes to the availability of mifepristone in the 18 states that filed that lawsuit.The conflicting orders by two federal judges, both preliminary injunctions issued before the full cases have been heard, appear to create a legal standoff likely to escalate to the Supreme Court. President Biden said his administration would fight the Texas ruling. “This does not just affect women in Texas,” he said in a statement. “If it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state.”The order by Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade, is an initial ruling in a case that could result in the most consequential abortion decision since the Supreme Court overturned Roe v. Wade last June.Read the Court Decision Invalidating F.D.A. Approval of MifepristoneA federal judge in Texas issued a preliminary ruling invalidating the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone on Friday, clashing with another court’s ruling in a legal standoff likely to escalate to the Supreme Court.Read Document 67 pagesOn Friday night, the Justice Department filed a notice that it is appealing the Texas ruling.“Today’s decision overturns the F.D.A.’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” Attorney General Merrick B. Garland said in a statement, adding that the Justice Department would ask that the decision be stayed while the appeal is pending. He said the department is reviewing the ruling in the Washington case.The lawsuit, filed by a coalition of anti-abortion groups and doctors, seeks to end more than 20 years of legal use of mifepristone, the first pill in the two-drug medication abortion regimen.The lawsuit in Washington State was filed against the F.D.A. by 18 Democratic attorneys general who were challenging the agency’s restrictions on the prescribing and dispensing of mifepristone. In a preliminary injunction in that case that he applied to the states that had sued, Judge Thomas O. Rice, who was appointed by President Barack Obama, blocked the agency from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”Read the Court Decision Ordering the F.D.A. to Keep Mifepristone AvailableA federal judge in Washington State issued a ruling ordering the Food and Drug Administration to make no changes to the availability of the abortion pill mifepristone on Friday, directly contradicting another judge’s ruling in a legal standoff likely to escalate to the Supreme Court.Read Document 31 pagesMedication abortion is the method used in more than half of abortions in the United States. The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication.The F.D.A. and the Justice Department have strongly disputed the claims in the lawsuit and said that the federal agency’s rigorous reviews of mifepristone over the years had repeatedly reaffirmed its decision to approve mifepristone, which blocks a hormone that allows a pregnancy to develop. In a statement Friday night, the agency said: “F.D.A. stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to F.D.A.-approved medications that F.D.A. has determined to be safe and effective for their intended uses.”In the 67-page Texas ruling, Judge Kacsmaryk appeared to agree with virtually all of the claims made by the anti-abortion groups and repeatedly used the language of abortion opponents, calling medication abortion “chemical abortion” and referring to a fetus as an “unborn human” or “unborn child.””The court does not second-guess F.D.A.’s decision-making lightly,” the judge wrote. “But here, F.D.A. acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”Are Abortion Pills Safe? Here’s the Evidence.The Times reviewed 101 studies of medication abortion, spanning continents and decades. All concluded that the pills are a safe method for terminating a pregnancy.A lawyer for Danco Laboratories, which makes the branded version of mifepristone, called Mifeprex, and had joined the lawsuit on the side of the F.D.A., forcefully disagreed with the judge’s characterizations.“The court’s ruling rewrites the facts and the law to tell its preferred narrative — which is a story line that conflicts with established legal principles and with Mifeprex’s well-established safety profile,” the lawyer, Jessica Ellsworth, said in a statement. Danco filed a notice that it was appealing the ruling.Erik Baptist, a lawyer for the anti-abortion groups that filed the Texas case called the decision “a significant victory for the doctors and medical associations we represent, and more importantly, the health and safety of women and girls.” Mr. Baptist, who is senior counsel for the Alliance Defending Freedom, a conservative Christian legal organization, said, “by illegally approving dangerous chemical abortion drugs, the F.D.A. put women and girls in harm’s way, and it’s high time the agency is held accountable for its reckless actions.”Legal experts said that even if the Texas ruling is ultimately upheld, there would be several legal options that could allow the manufacturers of mifepristone to continue supplying the drug and providers to continue prescribing it to patients.A still taken from a livestream of Judge Matthew Kacsmaryk’s nomination hearing to the federal bench in 2017.U.S. Senate Committee on the JudiciaryShortly after the rulings on Friday night, the chief executive of GenBioPro, one of the two manufacturers of mifepristone in the United States, issued a statement saying the company was reviewing the decisions of both judges.“We will take any steps necessary to lawfully make mifepristone available and accessible to as many people as possible in the country,” the statement from the C.E.O., Evan Masingill, said.And if legal access to mifepristone is blocked, some abortion providers plan to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries where mifepristone is less available. Misoprostol, a drug that is approved for other medical uses, causes contractions similar to a miscarriage and is considered slightly less effective on its own than in combination with mifepristone and more prone to cause side effects like nausea.Where Restrictions on Abortion Pills Could Matter Most in the U.S.A lawsuit is challenging the F.D.A.’s approval of medication abortion. Data shows the consequences could be far-reaching.In the Texas lawsuit, the plaintiffs also seek to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.Since last year’s Supreme Court ruling overturning the national right to abortion, the pills used in medication abortions have increasingly become the focus of political and legal battles. Some conservative states, in addition to banning or restricting abortion in general, have begun considering legislation that specifically targets abortion pills. And several recent lawsuits have been filed in efforts to preserve or expand access to medication abortion.The lawsuit filed in Washington state was intended to be a direct challenge to the Texas case. The Democratic attorneys general filed the case in late February on the first day that Judge Kacsmaryk could have issued a ruling. While its main claims sought to eliminate a framework of extra restrictions that the F.D.A. has long applied to mifepristone, the suit also asked 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.”In a news conference earlier this week, Washington’s attorney general, Bob Ferguson, characterized the lawsuit he and the other attorneys general filed as “the opposite of what’s going on in Texas.” He added “So the potential is there for two decisions or judges that are, in effect, contrary to one another. In other words, one judge in Texas could potentially say ‘Hey I’m issuing a ban on mifepristone nationwide’ and a judge in Washington State in the case with 17 other states could say ‘no, no, not only is it available, you got to expand access to it.’”People marched in Amarillo, Texas, in February to protest the lawsuit seeking to force the withdrawal of the F.D.A.’s approval of mifepristone.Meridith Kohut for The New York TimesThe case has caused a frenzy of concern in the reproductive health community. It was filed by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members and was incorporated in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk is the only federal judge covering the Amarillo division in the U.S. District Court of the Northern District of Texas. The F.D.A. has regulated mifepristone more stringently than many other drugs and has regularly reviewed evidence for its safety and effectiveness.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, that framework has been used for only about 300 other drugs, only 60 of which it currently covers.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 of the same anti-abortion organizations that filed the Texas lawsuit had previously filed, in 2002 and 2019, citizen petitions opposing the F.D.A.’s actions on mifepristone. Both were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities in the F.D.A.’s mifepristone approval.Legal experts said that the ruling appeared to be the first time that a court had acted to order that a drug be removed from the market over the objection of the F.D.A. and that if the ruling stood, it could have repercussions for federal authority to regulate other types of drugs.In his statement, Mr. Biden said, “If this ruling were to stand, then there will be virtually no prescription, approved by the F.D.A., that would be safe from these kinds of political, ideological attacks.”Adam Liptak

Read more →

Who Is Most At Risk for Long Covid?

A new analysis summarizes the emerging picture of factors that make long-term post-Covid symptoms more likely.Which coronavirus patients are most at risk for developing long Covid?A new analysis of research conducted during the first two years of the pandemic helps crystallize some answers that have been emerging.It found that patients over 40, those with previous health issues and those who had a severe coronavirus infection had greater risk of developing long Covid. And it affirmed a growing consensus that vaccination lowers that risk.The analysis, conducted by a team of researchers in Britain and published in the journal JAMA Internal Medicine, looked at 41 studies published between the beginning of the pandemic and Dec. 5, 2022. The studies, which had all been peer-reviewed, involved a total of 860,783 patients.The report evaluated the patients’ risk of post-Covid symptoms — including shortness of breath, fatigue, brain fog, headache, and loss of taste and smell — more than three months after their infection.People who received two doses of a Covid vaccine before becoming infected were 43 percent less likely to develop long Covid. The analysis did not look at the role of boosters.The authors wrote that the emerging evidence suggested that vaccination reduced the risk of long-term symptoms “even in individuals with other risk factors, such as older age or high B.M.I.”Other studies that were not included in the analysis have also suggested that vaccines can reduce, though not eliminate, the risk of long Covid.Risk factors analyzed in the paper included:Being femaleWomen were one and a half times as likely as men to develop long Covid. The authors and other researchers have suggested several possible reasons for this, including that hormone levels or disruption in hormone production may perpetuate inflammation caused by the initial infection and that higher levels of some antibodies in women might contribute to lingering symptoms.Being over 40The long Covid patients in the analysis were about 20 percent more likely to be older than 40. The analysis found that people 70 and older had the same risk as those who were 40 to 69, but the researchers suggested that might be because people over 70 were more likely to die from their initial infection.Being obesePeople were at increased risk for long Covid if they were obese, the analysis found. Obesity, they wrote, often involves a metabolic inflammatory process that could prolong post-Covid health issues.Being a smokerSmoking was also a risk factor, the researchers found, although they said it was unclear if that was because of the smoking itself or illnesses associated with smoking.Having previous medical conditionsOf the medical issues analyzed in the study, immunosuppressive conditions appeared to lead to the greatest increased risk of long Covid. People with chronic obstructive pulmonary disease, ischemic heart disease or asthma faced the next highest levels of increased risk. There was also elevated risk of long Covid for people with anxiety, depression, chronic kidney disease or diabetes.The sicker people were during their initial infection, the more likely they were to experience lingering health problems. Patients who were hospitalized, whether in intensive care or not, were nearly two and a half times as likely to develop long Covid than patients who were not hospitalized, the analysis found.“Patients with previous critical illness represent a high-risk population, and their follow-up should reflect intensive plans for prevention, rehabilitation and treatment of the ongoing debilitating symptoms,” the authors wrote.However, since a majority of people infected with the coronavirus have not needed to be hospitalized, there are greater numbers of long Covid patients whose initial infection was relatively mild.Other research, not included in the analysis, has focused on more detailed biological characteristics. One study published in 2022 found that people were more likely to develop long Covid if, at the time of their infection, they had factors including certain autoantibodies — antibodies that mistakenly attack tissues in the body as they do in conditions like lupus and rheumatoid arthritis — or reactivated Epstein-Barr virus, a virus that infects most people and then usually becomes dormant.The new analysis involved patients infected during waves of various coronavirus variants, but the authors did not analyze the variants separately.“It is unlikely that the risk factors” associated with long Covid would change with new variants, they wrote.

Read more →

Wyoming Judge Temporarily Blocks the State’s New Abortion Ban

Wyoming’s Constitution guarantees a right to make individual health care decisions. The new ban attempts to circumvent that right by declaring that abortion is not health care. Abortion will remain legal in Wyoming — at least temporarily — after a judge on Wednesday ordered that a newly enacted ban be blocked until further court proceedings in a lawsuit challenging it.After a three-hour hearing, Judge Melissa Owens of Teton County District Court granted a temporary restraining order, pausing a law that took effect Sunday. The law would make providing almost all abortions a felony punishable by up to five years in prison. The lawsuit — filed by six plaintiffs, including four health care providers — also challenges another law, scheduled to take effect on July 1, that would make Wyoming the first state to explicitly ban the use of pills for abortion. Now, the medication abortion ban and the overall ban will be considered at a hearing where the plaintiffs will seek an injunction to suspend both laws until the full lawsuit can be heard.A central issue is whether Wyoming’s Constitution allows the legislature to ban nearly all abortions, when the Constitution includes an amendment that guarantees adults the right to make their own health care decisions. An overwhelming majority of Wyoming citizens voted for the amendment in 2012.Similar battles over the constitutionality of state abortion plans have been playing out in other conservative states. In South Carolina and North Dakota, courts have ruled that abortion bans violate those states’ constitutions. In Idaho, courts have upheld the state’s abortion ban.Last year, Judge Owens blocked a previously enacted abortion ban, and a hearing on that is scheduled for December. The new ban, enacted earlier this month, was the legislature’s attempt to circumvent the constitutional guarantee of freedom in health care choices by declaring in the law that abortion is not health care.On Wednesday, Judge Owens questioned that assertion. “I’m just still hung up on abortion not being health care,” she said to the lawyer defending the laws for the state, Jay Jerde, a special assistant attorney general for Wyoming. “An abortion can only be performed by a licensed medical professional, so what authority does the legislature have to declare that abortion is not health care when our laws only allow a licensed medical professional to administer one?” she asked.Regarding medication abortion, she noted that abortion pills are regulated by the Food and Drug Administration. “How is a doctor actually prescribing those pills not health care?” she asked.Mr. Jerde said the legislature’s premise was that “intentional killing of an unborn child cannot be considered to be health care.” “I would concede that if you focus just on the pregnant woman, it becomes a little bit easier to say, well, this has to be health care,” he continued. “But if you view it from that other perspective, it clearly is not.”The plaintiffs include Dr. Giovannina Anthony, an obstetrician-gynecologist at the only clinic in Wyoming that has been providing abortions, and Wellspring Health Access, a clinic that plans to offer abortions when it opens this year. The other plaintiffs are another obstetrician-gynecologist who often treats high-risk pregnancies; an emergency room nurse; a fund that gives financing to abortion patients; and a woman who said her Jewish faith requires access to abortion if a pregnant woman’s physical or mental health or life is in danger.John Robinson, a lawyer for the plaintiffs, told Judge Owens that both the overall ban and the medication abortion ban violate several constitutional provisions because they “attempt to strip women of their rights to equality, health care and religion during a very specific life cycle, from conception to birth.” He said the laws signal that during pregnancy “the legislature does not consider the woman an equal member of the human race and Wyoming.”Mr. Jerde argued that the laws did not violate the constitutional provisions that the plaintiffs cited. He also said the implications of the plaintiffs’ arguments would be that a person with a health condition that might be treated with marijuana “would be free to possess and consume marijuana, regardless of the state laws that prohibit it and criminalize it.”Judge Owens said that only courts can decide whether the laws are constitutional.“To declare abortion is not health care when there may be evidence to show that it is — the legislature cannot make an end run around essentially providing a constitutional amendment,” she said, adding “the state cannot legislate away a constitutional right. It’s not clear if abortion is or isn’t health care, and the court has to then decide that.”

Read more →

Lawyers to Face Off Before Judge in Closely Watched Abortion Pills Case

The first hearing in a lawsuit that seeks to overturn F.D.A. approval of the pills takes place Wednesday morning in Texas.AMARILLO, Texas — A hearing Wednesday in a lawsuit that seeks to overturn federal approval of a widely used abortion pill will provide the first opportunity to hear the arguments of the anti-abortion groups that filed the lawsuit and of the Food and Drug Administration, which is fighting to keep the abortion pill legal.The lawsuit, which seeks to end more than 20 years of legal use of medications for abortion, could have widespread implications in states where abortion is legal, not just where it is illegal. Medication abortion is used in more than half of pregnancy terminations in the United States and 40 percent of clinics that provide abortion services offer abortion pills only, not the surgical procedure.The hearing on Wednesday will revolve around the plaintiffs’ request that Judge Matthew J. Kacsmaryk of the Northern District in Texas grant a preliminary injunction ordering the F.D.A. to withdraw its longstanding approval of mifepristone, the first pill in the two-drug medication abortion regimen, while the case proceeds through trial.Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade and previously worked for a Christian conservative legal organization, took some unusual steps leading up to the hearing. In a meeting last Friday with lawyers for the parties in the case, he asked them to keep quiet about the fact that a hearing had been scheduled and told them he planned to delay making the public aware of it and would only enter it into the public court record the evening before.In a transcript of the Friday meeting obtained by The New York Times, Judge Kacsmaryk said that other aspects of the case have “brought a barrage of death threats and protesters and the rest” and that he wanted to avoid an “unnecessary circus-like atmosphere” that might disrupt the lawyers’ presentations in court.Despite the judge’s request, news organizations learned about the hearing and reported it. Members of groups that support abortion rights are planning to demonstrate outside the court building while the hearing is in progress, including by wearing kangaroo and judge costumes to protest what they consider to be a “kangaroo court” and by driving a truck around the city streets with a billboard that will say “a majority of Americans support abortion access.”The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication. The F.D.A. and the Department of Justice, which is representing the F.D.A., have strongly disputed those claims, saying the F.D.A.’s rigorous reviews of mifepristone over the years had repeatedly reaffirmed its decision to approve mifepristone, which blocks a hormone that allows a pregnancy to develop. It is unclear if the judge will rule at the end of the session Wednesday. Most legal experts expect that he will make his decision at a later date.Here are some of the issues that the judge has asked lawyers to be prepared to discuss at the hearing:Whether the plaintiffs have legal standing to bring the lawsuitThe plaintiffs are led by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members. Shortly after the Supreme Court overturned Roe v. Wade, the alliance was incorporated in August in Amarillo, where Judge Kacsmaryk is the only federal judge.The five groups are not based in Amarillo, but Erik Baptist, senior counsel for the Alliance Defending Freedom, a conservative Christian legal advocacy group that is representing the plaintiffs, said that some of the groups’ members are in the Amarillo area, as is one of the four doctors who are plaintiffs in the case.The plaintiffs contend they have legal standing to sue as parties who experienced injury from the F.D.A. approval because they have treated women who they say have suffered harm from abortion pills. Legal experts, including some conservative legal scholars, said it might be difficult to support a claim that the plaintiffs have standing because the harm they are claiming could be considered several steps removed from the F.D.A.’s approving the drug. The intermediate steps include patients choosing to take the drug and then seeking medical care.If the judge were to decide that the plaintiffs do not have legal standing to sue, then the case could not proceed.Whether this lawsuit is an appropriate legal challenge to the F.D.A.’s authorityThe judge has indicated that he expects the parties to discuss issues related to the F.D.A.’s authority to approve and regulate drugs. Some legal experts have pointed to constitutional provisions and Congressional actions that suggest that the F.D.A. has overarching authority that cannot be second-guessed by a court. Legal experts say that if the judge were to rule for the plaintiffs, it would apparently be the first time a court had acted to order that a drug be removed from the market over the objection of the F.D.A.The F.D.A. has also said in its filing in the case that there is a six-year statute of limitations to challenge the agency’s actions and that the plaintiffs are bringing this lawsuit much too late.The plaintiffs argue that their lawsuit is an appropriate legal action.Did the F.D.A. err in approving mifepristone under the regulation used at the time?Mifepristone was initially approved in 2000 under a set of regulations called “Subpart H,” which was created to expedite the approval of drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses.”The lawsuit alleges that mifepristone did not qualify for this type of approval because the plaintiffs say that “pregnancy is not an illness.”The approval process for mifepristone was not expedited — it took over four years — but the F.D.A. applied Subpart H, which allowed the agency to impose additional restrictions on use of the drug, including requiring health care providers to have special qualifications to prescribe it and dispense it only in certain medical settings.The F.D.A. argues that “illness” is a term that generally applies to medical conditions, not only to diseases. The agency says that any confusion in semantics was cleared up several years later when Congress created a new regulatory framework that used the term “disease or condition.”Are abortion medications unsafe?The plaintiffs claim that the pills, which they call “chemical abortion,” cause “cramping, heavy bleeding and severe pain” and that the F.D.A. has never adequately evaluated the scientific evidence for safety.The F.D.A. vigorously disputes this claim, as do mainstream medical organizations. They say that bleeding and cramping are normal consequences of the process, a sign that the pregnancy tissue is being expelled, and cite years of scientific studies that show that serious complications are rare. The organizations note that mifepristone has actually been regulated much more strictly and studied more intensively than most other drugs.For a dozen years, the F.D.A. has imposed on mifepristone an additional framework of restrictions and monitoring called a Risk Evaluation and Mitigation Strategy, or REMS. It is a framework that has been used for only about 300 other drugs. In recent years, the F.D.A. has extensively reviewed new data on mifepristone and concluded that the drug was safe enough to lift several of the restrictions, including the requirement that patients obtain the drug in person from a provider.

Read more →

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.”

Read more →

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.

Read more →

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.”

Read more →

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.

Read more →

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 Rebouché, 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.”

Read more →

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.”

Read more →