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U.S. publisher retracts studies cited by Texas judge in suspending abortion pill's approval

[February 07, 2024] By Brendan Pierson

(Reuters) -A U.S. scientific publisher has retracted two studies, largely due to their methodology, that a Texas judge cited last year in his ruling suspending federal approval of the abortion pill mifepristone in response to a lawsuit by anti-abortion doctors and medical associations.

The retraction Monday by Sage Publications came less than two months before the U.S. Supreme Court is expected to hear an appeal by President Joe Biden's administration in that case. Mifepristone, the first in a two-pill regimen for medication abortion, remains available while the appeal is pending.

The lead author of the studies was public health researcher James Studnicki, a vice president at the anti-abortion Charlotte Lozier Institute.

"The Charlotte Lozier Institute rejects this baseless attack on our scientific research and studies," Studnicki and Tessa Longbons, a research associate at the institute and co-author, said in a statement. "To date, Sage has advanced no valid objection to their findings and no legitimate reason for their retraction."

One of the studies found that abortions using mifepristone are followed by a high rate of emergency room visits compared to surgical abortions.

The American College of Obstetricians and Gynecologists says that mifepristone is "exceedingly safe and effective."

U.S. District Judge Matthew Kacsmaryk in Amarillo cited that study in concluding that the plaintiffs had legal standing to bring their lawsuit challenging the pill's approval, because they would be harmed by having to treat patients suffering from complications following medication abortions. The plaintiffs' standing is expected to be a key issue in the appeal.

The other study found that such complications are frequently misclassified as miscarriages, which Kacsmaryk cited to support his finding that the true rate of complications is underreported.

Sage said in its retraction notice that it had independent experts look at the two studies, as well as a third study led by Studnicki, in response to a reader's concern.

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A patient prepares to take Mifepristone, the first medication in a medical abortion, at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. REUTERS/Evelyn Hockstein

The experts found "fundamental problems" that "invalidate the authors' conclusions in whole or in part," according to Sage, which publishes more than 1,000 journals including Health Services Research and Managerial Epidemiology, where the retracted articles appeared.

The publisher also said that the authors' affiliations with the Charlotte Lozier Institute and other anti-abortion organizations should have been disclosed as a conflict of interest, and that one of the original peer reviewers was also affiliated with the institute.

Kacsmaryk in April suspended the U.S. Food and Drug Administration's 2000 approval of the drug, ruling in favor of the Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians & Gynecologists and others.

A federal appeals court later reinstated the original approval but reimposed old restrictions on the pill that the FDA had since lifted, including a ban on prescribing it by telemedicine and dispensing it by mail. That decision is on hold while the Biden administration appeals, and the Supreme Court has declined to consider banning the pill altogether as Kacsmaryk originally did.

Medication abortion accounted for a majority of abortions in the United States as of 2022, according to the Guttmacher Institute, a research group that supports abortion rights.

David Cohen, a professor of law at Drexel University who focuses on constitutional law and abortion rights, said there was "minimal likelihood" that the retraction would affect the Supreme Court's decision.

(Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Cynthia Osterman)

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