Medical journal Two studies were retracted The safety of the abortion pill mifepristone has been examined after a federal judge in Texas cited it when ruling to take the drug off the market.
The studies, which were retracted due to methodological problems and conflicts of interest, claimed that abortions involving mifepristone were associated with a higher risk of serious complications than procedural abortions. These conclusions contradict Hundreds of studies In the past two decades, researchers have determined that mifepristone, which is currently approved by the US Food and Drug Administration for use in abortion during the first 10 weeks of pregnancy, is safe and effective. Mifepristone is It is used in combination with misoprostol In almost all medical abortions in the United States, medical abortions accounted for more than half of all abortions nationwide in 2020.
A third study written by the same authors was also withdrawn, but the judge did not refer to it. It was about doctors prescribing mifepristone. All three papers have been published in Health services research and managerial epidemiology, Published by Sage Magazines. She appeared in the magazine in 2019, 2021 and 2022.
About supporting scientific journalism
If you enjoyed this article, consider supporting our award-winning journalism by Subscribe. By purchasing a subscription, you help ensure a future of impactful stories about the discoveries and ideas shaping our world today.
The papers attracted attention after the Hippocratic Medicine Alliance, a group of doctors and anti-abortion organizations, Filed a lawsuit against the US Food and Drug Administration In November 2022. The coalition claimed that the FDA had not followed proper procedures in approving the drug for more than two decades and that it had Reduce the risks of mifepristone. When the lawsuit is filed, the alliance also She requested a preliminary injunction To immediately remove mifepristone from the market.
In court documents, the US Department of Justice (which represents the FDA in legal matters) called this request “extraordinary and unprecedented.” the The Justice Department argued “Plaintiffs have not cited any case, and the government has been unable to identify any example, in which the court second-guessed the safety and effectiveness of the FDA and ordered the removal of a widely available, FDA-approved drug from the market — let alone it.” Example includes a two-decade delay.
Last April, Judge Matthew Kasmarek of the Northern District of Texas cited the 2021 and 2022 papers when he ruled that the coalition had the right to sue, agreeing with the plaintiffs’ contention that mifepristone places a heavy burden on emergency room doctors who treat pregnant women with medical problems. Complications. Kacsmaryk issued a preliminary ruling invalidating the FDA’s approval of mifepristone.
The Supreme Court stayed the ruling until the US Court of Appeals for the Fifth Circuit could issue a ruling. That court Hit part of Kacsmaryk Ruling after a few days, mifepristone is allowed to remain on the market with certain restrictions.
The Court of Appeal ruling remains pending while the case is pending before the Supreme Court, which is scheduled to hear arguments on it in March.
for now, Mifepristone remains available Up to 10 weeks of pregnancy, with prescriptions permitted via telemedicine and by mail in states where abortion is legal.
Safety of mifepristone
Research shows that mifepristone, which has been used by more than five million pregnant women in the United States since then It was approved in 2000It has an excellent safety record, says Ushma Upadhyay, a professor and public health scientist at the University of California, San Francisco. “Judge Kaczmarek’s decision ignored science and relied only on a few cherry-picked research papers that supported his beliefs about abortion,” says Upadhyay, author of a new study. Published last week in Natural medicine, Which have been found can be safely prescribed through telemedicine.
A coalition of medical groups – incl American College of Obstetricians and Gynecologists and American Medical AssociationHe described the evidence on the safety of mifepristone as “overwhelming.”
Serious side effects occur in less than 1% of drug users. According to the summary filed by the medical groups in the U.S. District Court for the Northern District of Texas prior to the Kaczmarek decision. Major adverse events such as major infection, blood loss, or hospitalization occur in less than 0.3 percent.
Deaths are much rarer. According to the FDA, of the estimated 3.7 million women who used mifepristone to terminate a pregnancy in the United States from 2000 to 2018, 24 women died. This number includes those who recently took mifepristone and died of an unattributable cause, such as homicide, suicide, or an overdose of another drug. Which Equivalent to the death rate By 0.00065 percent.
“The risk of death is almost non-existent,” the summary said. “Mifepristone is one of the most studied prescription drugs in the United States, and has a safety profile comparable to [that of] “Ibuprofen.”
A study published in the journal contraception Last year I found that out Risk of death due to pregnancy and childbirth At least 35 times greater than legal abortion.
Controversial studies
Sage Journals said in a statement on its website asked two independent experts To review articles about mifepristone after a reader expressed concerns about the methodology of the papers and the authors’ undisclosed conflicts of interest.
In the 2021 study, which examined patient data from 1999 to 2015, researchers found that abortion-related emergency department visits were 50 percent more likely after an abortion with mifepristone than after a procedural abortion. This led them to conclude that “mifepristone abortion is consistently and progressively associated with increased morbidity” compared to procedural abortions.
But the study, which focused on people covered by Medicaid, provides little evidence that those individuals experienced a miscarriage-related adverse event, says Chris Adkins, an associate professor of pharmaceutical sciences at South University in Savannah, Georgia, who identified himself as the reader who asked. Sage Journals for articles.
Pregnant women in the withdrawn 2021 study could have gone to the emergency department for any number of reasons, from food poisoning to earaches, Adkins says, adding that he does not speak for his university. Research shows that half of all emergency room visits occur after a miscarriage It has nothing to do with abortion. Many people, including those who qualify for Medicaid, go to the emergency room for non-emergency needs because they cannot access care anywhere else.
Some people who undergo medical abortion visit emergency departments “simply to determine if the amount of bleeding and cramping is normal,” Adkins says. “A significant number of these ER visits are merely observational care and not a true miscarriage-related adverse event.”
The 2021 study also failed to provide important context, including the significant increase in Medicaid enrollment during the study period (between 1999 and 2015), partly due to the Affordable Care Act, Adkins says. Number of Americans enrolled in Medicaid It increased from 34.1 million in 2000 to 71.5 million in 2015.
Although the authors of the 2021 article declared that they had no conflicts of interest when they submitted it for publication, all but one of them belonged to anti-abortion advocacy groups, including the Charlotte Lozier Institute, the Elliott Institute, and the American Society of Pro-Life Obstetricians And obstetricians. Gynecologists. This paper and a retracted 2022 study conducted by the same authors were funded by the Charlotte Lozier Institute, the research and education institute of Susan B. Anthony Pro Life America, an influential anti-abortion group.
The peer reviewer who originally evaluated the articles was also affiliated with the Charlotte Lozier Institute at the time, leading the publisher to later conclude that the reviewer’s work was “unreliable,” according to a Sage Journals statement.
The independent experts who recommended the three retractions found that the articles from 2021 and 2022 contained “fundamental problems in study design and methodology, unwarranted or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data.” Which, in their opinions, shows a lack of scientific rigor and invalidates the authors’ conclusions in whole or in part, according to the statement.
James Studnicki, lead author of the three studies and vice president and director of data analytics at the Charlotte Lozier Institute, Published a point by point refutation From reviews of Sage magazines. He wrote that he and his colleagues made no attempt to hide their affiliations. Articles included a brief biography indicating the researchers’ affiliations. In an emailed response to scientific American, A spokesperson for Sage Journals said it “relies on journal editors to make individual decisions about submitted work. These journal editors rely on peer reviewers to assess the quality of a submitted article and determine whether it is rigorous and ultimately whether it is acceptable for publication. We work together to take corrective action when necessary .
Studnicki and Tessa Longbones, associate researchers at the Charlotte Lozier Institute and co-authors of the three papers, claim their studies were targeted by politics. In the video Published onlineMost medical journals are “strongly pro-abortion,” Studnicki claimed.
“This incident points to a larger and more recent phenomenon: that many of our scientific institutions and publications no longer advocate for open investigation,” Studnicki and Longbones wrote in an email comment. American Scientific. “We are witnessing a biased faction of the elite across the medical community trying with all their might to suppress any research that contradicts their approved pro-abortion narrative. Scientific research and publishing should be grounded in science, not driven by ideology.”
Critics of the withdrawn papers say their concerns are practical, not personal or political.
“It’s not about ideology,” Upadhyay says. “The retraction of these studies is based on their flawed scientific approach that grossly distorts the safety classification of abortion.”
Influencing future legal decisions
Mary Ziegler, a professor at the University of California, Davis School of Law, who studies the history of abortion, says the reversals are “unlikely to make much difference legally” in terms of future court decisions or legislation.
State lawmakers who try to restrict or ban abortion generally seem motivated more by a desire to protect the fetus than by concerns about protecting pregnant women from potential adverse events, Ziegler says.
She says the Fifth Circuit Court of Appeals’ decision on mifepristone was not based on retracted papers, but on other testimony.
The Supreme Court, which voted in 2022 to overturn it Roe v. Wade Ziegler says reversals (the landmark case that legalized abortion in 1973) are unlikely to be affected either. “Given the problems with the plaintiffs’ case, the court may actually be inclined to side against the Alliance for Hippocratic Medicine,” she says. “If judges are willing to overlook other issues regarding the standing and weight of evidence related to mifepristone, reversals will likely do little more than strengthen the existing position.”