A medical journal has retracted two studies examining the safety of the abortion pill mifepristone after a federal judge in Texas cited them when ruling that the drug should be taken off the market.
The studies, both retracted because of methodology problems and conflicts of interest, claimed abortions involving mifepristone are associated with an increased risk of serious complications compared with procedural abortions. Those conclusions are in contrast with hundreds of studies in the past two decades that have found that mifepristone—currently approved by the U.S. Food and Drug Administration for use in abortion through 10 weeks of pregnancy—is safe and effective. Mifepristone is used in combination with the drug misoprostol in nearly all medication abortions in the U.S., and medication abortions constituted more than half of abortions nationwide in 2020.
A third study that was written by the same authors but not referenced by the judge was also retracted; it was about doctors who prescribe mifepristone. All three papers were published in Health Services Research and Managerial Epidemiology, which is published by Sage Journals. They appeared in the journal in 2019, 2021 and 2022.
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The papers drew attention after the Alliance for Hippocratic Medicine, a group of antiabortion doctors and organizations, sued the U.S. Food and Drug Administration in November 2022. The alliance claimed that the FDA did not follow proper procedures in approving the drug more than two decades ago and that it has downplayed mifepristone’s risks. When filing its suit, the alliance also asked for a preliminary injunction to immediately remove mifepristone from the market.
In court documents, the U.S. Department of Justice (which represents the FDA in legal matters) described that request as “extraordinary and unprecedented.” The DOJ argued that “plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market—much less an example that includes a two-decade delay.”
Last April Judge Matthew Kacsmaryk of the Northern District of Texas cited the 2021 and 2022 papers when he ruled that the alliance had standing to sue, agreeing with the plaintiffs’ claim that mifepristone puts a heavy burden on emergency room physicians treating pregnant people who experience medical complications. Kacsmaryk issued a preliminary ruling invalidating the FDA’s approval of mifepristone.
The Supreme Court halted the ruling until the U.S. Court of Appeals for the Fifth Circuit could issue a ruling. That court struck down part of Kacsmaryk’s ruling a few days later, allowing mifepristone to remain on the market with certain restrictions.
The appeals court ruling is on hold while the case is under consideration by the Supreme Court, which is scheduled to hear arguments about it in March.
For now, mifepristone remains available through 10 weeks of pregnancy, with prescriptions permitted by telemedicine and through the mail in states where abortion is legal.
Mifepristone’s Safety
Research shows that mifepristone, which has been used by more than five million pregnant people in the U.S. since it was approved in 2000, has an excellent safety record, says Ushma Upadhyay, a professor and public health scientist at the University of California, San Francisco. “Judge Kacsmaryk’s decision ignored the science and relied on just the few cherry-picked research papers that supported his beliefs about abortion,” says Upadhyay, author of a new study, published last week in Nature Medicine, that found mifepristone can be safely prescribed through telemedicine.
A coalition of medical groups—including the American College of Obstetricians and Gynecologists and the American Medical Association—describe the evidence for mifepristone’s safety as “overwhelming.”
Serious side effects occur in fewer than 1 percent of those using the drug, according to a brief that the medical groups filed with the U.S. District Court for the Northern District of Texas before Kacsmaryk’s decision. Major adverse events such as significant infection, blood loss or hospitalization occur in fewer than 0.3 percent.
Deaths are even rarer. According to the FDA, of the estimated 3.7 million women who used mifepristone to terminate a pregnancy in the U.S. from 2000 to 2018, 24 died. This number includes those who had recently taken mifepristone and died from a cause that was not attributed to it, such as homicide, suicide or an overdose of another drug. That equates to a mortality rate of 0.00065 percent.
“The risk of death is almost non-existent,” the brief states. “Mifepristone is one of the most studied medications prescribed in the United States and has a safety profile comparable to [that of] ibuprofen.”
A study published in the journal Contraception last year found that the risk of death from pregnancy and childbirth is at least 35 times greater than from a legal abortion.
Controversial Studies
In a statement on its website, Sage Journals said it asked two independent experts to review the articles about mifepristone after a reader expressed concerns about the papers’ methodology and the authors’ undisclosed conflicts of interest.
In the 2021 study, which examined patient data from 1999 to 2015, the researchers found that abortion-related emergency department visits were 50 percent more likely after an abortion using mifepristone than a procedural abortion. This led them to conclude that “mifepristone abortion is consistently and progressively associated with increased morbidity” compared with procedural abortions.
But the study, which focused on people covered by Medicaid, provides little evidence that those individuals experienced an adverse event related to abortion, says Chris Adkins, an associate professor of pharmaceutical sciences at South University in Savannah, Ga., who has identified himself as the reader who questioned Sage Journals about the articles.
Pregnant people in the retracted 2021 study could have gone to the emergency department for any number of reasons, from food poisoning to earaches, Adkins says, adding that he doesn’t speak for his university. Research shows that half of emergency room visits made after an abortion are unrelated to abortion. And many people, often including those who qualify for Medicaid, go to the emergency room with nonemergency needs because they can’t access care anywhere else.
Some people who have medication abortions 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 just observational care and not a true abortion-related adverse event.”
The 2021 study also failed to provide important context, including the substantial increase in Medicaid enrollment during the study period (between 1999 and 2015), partly as a result of the Affordable Care Act, Adkins says. The number of Americans enrolled in Medicaid grew 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 were affiliated with antiabortion advocacy groups, including the Charlotte Lozier Institute, the Elliot Institute and American Association of Pro-Life Obstetricians and Gynecologists. That paper and a retracted study from 2022 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 antiabortion group.
A 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 Sage Journals’ statement.
The independent experts who recommended the three retractions found that the articles from 2021 and 2022 contained “fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data that, in their opinions, demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part,” according to the statement.
James Studnicki, lead author of all three studies and vice president and director of data analytics at the Charlotte Lozier Institute, posted a point-by-point rebuttal of Sage Journals’ critique. He and his co-authors had made no attempt to hide their affiliations, he wrote. The articles did include a brief biography that noted researchers’ affiliations. In an e-mailed response to Scientific American, a Sage Journals spokesperson said it “relies on journal editors to make individual decisions on submitted works. These journal editors rely on peer reviewers to evaluate the quality of a submitted article and determine if it is rigorous and ultimately, if it is acceptable for publication. We work together to take corrective action when necessary.”
Studnicki and Tessa Longbons, a senior research associate at Charlotte Lozier Institute and a co-author of the three papers, claim their studies are being targeted because of politics. In a video posted online, Studnicki alleged that most medical journals are “virulently proabortion.”
“This incident points to a larger, newer phenomenon, which is that many of our scientific institutions and publications no longer stand in defense of open inquiry,” Studnicki and Longbons wrote in an e-mailed comment to Scientific American. “We’re seeing a biased elite faction across the medical community with all the power attempting to suppress any research that cuts against their approved, pro-abortion narrative. Scientific research and publication should be grounded in science, not driven by ideology.”
Critics of the retracted papers say their concerns are practical—not personal or political.
“This is not about ideology,” Upadhyay says. “The retraction of these studies is based on their flawed scientific approach which grossly distorts the safety rating for abortion.”
Effect on Future Legal Decisions
The retractions are “unlikely to make much difference legally” in terms of future court decisions or legislation, says Mary Ziegler, a professor at the University of California, Davis, School of Law, who studies the history of abortion.
State lawmakers trying to restrict or outlaw abortion generally seem more motivated by a desire to protect the fetus than by concerns about protecting pregnant people from potential adverse events, Ziegler says.
The Fifth Circuit Court of Appeals’ decision on mifepristone relied not on the retracted papers but on other testimony, she says.
The Supreme Court, which voted in 2022 to overturn Roe v. Wade (the landmark case that legalized abortion in 1973), is unlikely to be swayed by the retractions either, Ziegler says. “Given the problems with the plaintiffs’ case for standing, the Court may already be inclined to side against the Alliance for Hippocratic Medicine,” she says. “And if the justices are prepared to overlook other issues with standing and the weight of the evidence on mifepristone, the retractions will likely not do more than reinforce an existing position.”