‘Unreliable’: Studies cited by judge in 2023 abortion pill case have been retracted by publisher

One of the most important issues to be decided by the Supreme Court this term will be the continued availability of an FDA-approved medication used in more than half of all abortions occurring in the United States. For over two decades, that medication, mifepristone, is typically used in tandem with another medicine, misoprostol, as a safe and effective means of terminating pregnancies in this country.

Because it can end a pregnancy without a visit to a facility that provides abortion care, the so-called abortion pill reduces opportunities for right-wing zealots to terrify, threaten, or otherwise prevent patients from exercising their reproductive rights. Laws prohibiting medication abortions have of course proliferated in Republican-dominated states, but those laws can realistically extend only to a state’s borders. 

In their intense desperation to halt the sale of mifepristone, forced-birth proponents have relied on fatuous claims about the drug’s safety in order to bolster their arguments for banning it altogether, or severely restricting access to it. To bolster those claims, a network of like-minded physicians and scientists has emerged. They generate seemingly authoritative research papers specifically for the purpose of influencing and providing plausible authority to receptive judges, such as Judge Matthew Kacsmaryk of the Northern District of Texas.

Those judges point to that “research” as justification for their rulings, often citing the papers in their legal opinions. A case currently before the Supreme Court, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, followed this pattern, with Kacsmaryk specifically citing two research papers purporting to show that the FDA was negligent in approving mifepristone, and one of the pair to justify the standing of forced-birth organizations to sue the FDA. In a ruling last April, Kacsmaryk invalidated FDA approval of mifepristone; that drastic action was modified by the Court of Appeals pending review by the Supreme Court, which agreed last December to hear the case.

However, since Kacsmaryk penned his confident screed declaring mifepristone medically unsafe and unilaterally invalidating its FDA approval, the research papers he relied upon have been retracted by their publisher—rendering them essentially worthless as sources of authority. 

As reported by Laura Ungar and Matthew Perrone, writing for The Associated Press:

A medical journal has retracted two studies claiming to show the harms of the abortion pill mifepristone, citing conflicts of interest by the authors and flaws in their research

Two of the three studies retracted by medical publisher Sage Perspectives were cited in a pivotal Texas court ruling that has threatened access to the pill. The U.S. Supreme Court will take up the case next month, with a decision expected later this year. The court’s ruling could impact nationwide access to mifepristone, including whether it continues to be available by mail.

As Ungar and Perrone report, the papers were published the journal “Health Services Research and Managerial Epidemiology.” One purported to show an increase in “ER visit morbidity” following medication abortions. Another indicated that failure to disclose a prior abortion was a “significant risk factor for a subsequent hospital admission.”

But as reported by Selena Simmons-Duffin for NPR’s “Morning Edition,” after conducting a “thorough, fair and careful” review, Sage concluded that those studies were unreliable. The 2021 “Longitudinal Cohort Study” and its 2022 follow-up study were specifically cited by Kacsmaryk. 

Sage, the publisher of the journal, retracted the study on Monday along with two other papers, explaining in a statement that “expert reviewers found that the studies demonstrate a lack of scientific rigor that invalidates or renders unreliable the authors’ conclusions.”

It also noted that most of the authors on the paper worked for the Charlotte Lozier Institute, the research arm of anti-abortion lobbying group Susan B. Anthony Pro-Life America, and that one of the original peer reviewers had also worked for the Lozier Institute.

As NPR notes, James Studnicki, lead author of one of the retracted studies, posted a video where he accuses the Sage publisher of “political assassination of science,” claiming that his research was being “canceled:” 

He says that because the study’s findings have been cited in legal cases like the one challenging the abortion pill, “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,” Studnicki says in the video.

People are in fact quoting Studnicki and his forced-birth organization, the Charlotte Lozier Institute. Specifically, that organization was cited as authoritative by Justice Samuel Alito in the Dobbs decision overruling Roe v. Wade.

Sage, however, stands by its findings. As reported by Sofia Resnick, writing for the Oregon Capitol Chronicle, Sage was alerted to the alleged misrepresentation of data in Studnicki’s study by pharmaceutical sciences professor Chris Adkins.

“I can’t prove that there was intent to deceive, but I struggled to find an alternative reason to present your data in such a way that exaggerates the magnitude,” Adkins told States Newsroom at the time. “They’re misrepresenting its conclusions to begin with.”

The epidemiology and public health experts who conducted an independent post-publication peer review of the three studies ultimately agreed with Adkins. Regarding the 2021 and a follow-up 2022 paper using the same dataset, the experts found “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.”

The 2019 article, using a different dataset, contained “unsupported assumptions,” “misleading presentations of the findings,” and “demonstrate a lack of scientific rigor and render the authors’ conclusion unreliable,” the experts found.

The vast bulk of research shows that mifepristone is safe and effective, and as Resnick points out, “Experts have cited mifepristone’s safety and efficacy with more than 5.6 million uses over the past two decades.”

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion

For this Supreme Court, however, the retractions may not matter. The Court’s right-wing majority has already demonstrated it is quite willing—even eager—to deny people’s right to make their own reproductive decisions. The opportunity to inflict their religious sensibilities on those still allowed to terminate an unwanted pregnancy—people in states that Dobbs couldn’t reach—may prove impossible to resist. Whether that means repudiating the FDA’s judgment on mifepristone altogether, or simply creating more barriers and hurdles to its availability remains to be seen.

The Court’s decision is expected to be issued this summer. Anyone who can get pregnant, or cares about someone who can, should be paying attention.

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