Journal retracts studies cited in federal court ruling against abortion pill

An academic journal publisher recently retracted two studies that were cited by a federal judge in Texas last year when he ruled that the abortion pill mifepristone should be taken off the market.

Most of the authors of the studies are doctors and researchers affiliated with anti-abortion groups, and their reports suggested that medication abortion causes dangerous complications, contradicting widespread evidence that abortion pills are safe.

The lawsuit in which the studies were cited will be heard by the Supreme Court in March. The high court’s ruling could have major implications for access to medication abortion, which is now the most common method of pregnancy termination.

The publisher, Sage Journals, said it had asked two independent experts to evaluate the studies, published in 2021 and 2022 in the journal Health Services Research and Managerial Epidemiology, after a reader raised concerns.

Sage said both experts had “identified 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.”

The publisher also retracted a third study by many of the same authors that was published in 2019 in the same journal, which did not figure in the mifepristone lawsuit.

Sage said that when it had begun examining the 2021 study, it confirmed that most of the authors had listed affiliations with “pro-life advocacy organizations” but had “declared they had no conflicts of interest when they submitted the article for publication or in the article itself.”

Sage said it had also learned that one of the reviewers who evaluated the article for publication was affiliated with the Charlotte Lozier Institute, the research arm of Susan B. Anthony Pro-Life America.

The institute denied that the studies were flawed, as did the lead author, James Studnicki, who is vice president and director of data analytics at the institute.

“Sage is targeting us,” Studnicki, who has a doctor of science degree and a master’s degree in public health, said in a video defending the team’s work.

Noting that the studies had been used in legal actions, he said: “We have become visible, people are quoting us, and for that reason we are dangerous, and for that reason they want to cancel our work. What happened to us has little or nothing to do with real science and has everything to do with political assassination.”

In a statement, Studnicki said, “The authors will be taking appropriate legal action,” but he did not specify what that would be.

The lawsuit seeking to bar mifepristone – the first pill in the two-drug medication abortion regimen – was filed against the Food and Drug Administration by a consortium of groups and doctors who oppose abortion. In fighting the lawsuit, the federal government has defended its approval and regulation of mifepristone, provided years of evidence that the pill is safe and effective and argued that the plaintiffs have no legal standing to sue because they are not abortion providers and have not been harmed by mifepristone’s availability.

In his opinion last April, Judge Matthew Kacsmaryk cited the 2021 study to support his conclusion that the plaintiffs had legal standing to sue. That study reported a higher rate of emergency room visits after medication abortions than after procedural abortions. Citing it, Kacsmaryk wrote that the plaintiffs “have standing because they allege adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications.”

In another section of his ruling, Kacsmaryk cited the 2022 study, writing that “plaintiffs allege ‘many intense side effects’ and ‘significant complications requiring medical attention’ resulting from Defendants’ actions.”

Kacsmaryk’s opinion was criticized by many legal experts, and an appeals court struck parts of it but said significant restrictions should be placed on mifepristone that would prevent it from being mailed or prescribed by telemedicine.

Legal experts said it was unclear if Sage’s action would affect the Supreme Court’s decision. Mary Ziegler, a law professor at the University of California, Davis, said the retractions might simply “reinforce a position they were already ready to take.”

For example, she said, there were strong arguments that the plaintiffs lacked legal standing, so if a justice was “willing to overlook all that other stuff, you may be willing to overlook the retractions too,” she said. For justices “bothered by various other problems with standing, you probably were potentially going to say the plaintiffs didn’t have standing as it was.”

Similarly, she said, some justices would have concluded that the vast majority of studies show mifepristone is safe, so if a justice was “prepared to say that, notwithstanding the weight of the evidence, mifepristone is really dangerous, you could easily do that again if you lose a couple of studies.”

This article originally appeared in The New York Times.