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Journal retracts studies cited in federal court ruling against abortion pill

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This week a publisher of scientific journals two investigations withdrawn that were cited last year by a federal judge in Texas when he ruled that the abortion pill mifepristone should be removed from the market.

Most of the study authors 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 citing the studies will be heard by the Supreme Court in March. The Supreme Court's ruling could have major implications for access to medication abortion, which is now the most common method of termination of pregnancy.

The publisher, Sage Journals, said it had asked two independent experts to review 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, unwarranted or incorrect factual assumptions, material errors in the authors' analysis of the data and misleading presentations of the data that, in their view, lacked to demonstrate scientific knowledge.” accuracy and invalidate the authors' conclusions in whole or in part.”

The publisher also withdrew a third study by many of the same authors, published in the same journal in 2019 and not covered in the mifepristone lawsuit.

Sage said that when it began investigating the 2021 study, it confirmed that most of the authors had reported ties to “pro-life advocacy organizations” but “declared that they had no conflicts of interest when they submitted the article for publication or in the article itself.”

Sage said it also learned that one of the reviewers who assessed the paper for publication was 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, vice president and director of data analytics at the institute.

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

Noting that the investigations 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 everything to do with political murder.”

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

The lawsuit to ban mifepristone — the first pill in the two-drug abortion regimen — was filed against the Food and Drug Administration by a consortium of anti-abortion groups and doctors. In its fight against the lawsuit, the federal government has defended its approval and regulation of mifepristone, providing years of evidence that the pill is safe and effective and arguing that the plaintiffs have no legal standing to sue because they are not abortion providers and suffered no damage. due to the availability of mifepristone.

In his opinion last April, Judge Matthew J. cited Kacsmaryk the 2021 survey in support of his conclusion that the plaintiffs had legal standing to sue. That study reported a higher number of emergency room visits after medication abortions than after procedural abortions. Citing this, Judge Kacsmaryk wrote that the plaintiffs “have standing because they allege that side effects of chemical abortion drugs can overwhelm the medical system and place 'enormous pressure and stress' on physicians during emergencies and complications.”

In another part of his ruling, Judge Kacsmaryk quoted the 2022 study, writing that “Plaintiffs allege 'many intense side effects' and 'significant complications requiring medical attention' as a result of Defendants' actions.”

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

Legal experts said it was unclear whether Sage's action would influence the Supreme Court's decision. Mary Ziegler, a law professor at the University of California, Davis, said the retractions could simply “reinforce a position they were already willing to take.”

For example, she said, there were already strong arguments that the plaintiffs had no legal standing, so if a judge “was willing to overlook all these other issues, maybe you're willing to overlook the retractions too.” she said. For judges who were already “hampered by various other standing issues, you could probably say that the plaintiffs did not have standing as it was.”

Likewise, she said, some judges may have already concluded that the vast majority of research shows that mifepristone is safe, so if a judge were “willing to say that mifepristone, despite the weight of the evidence, is really dangerous, you could easily do that. Even if you lose a few studies.”

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