Scientific journal publisher Sage has retracted key abortion studies cited by anti-abortion groups in a legal case aiming to revoke regulatory approval of the abortion and miscarriage medication, mifepristone—a case that has reached the US Supreme Court, with a hearing scheduled for March 26.
On Monday, Sage announced the retraction of three studies, all published in the journal Health Services Research and Managerial Epidemiology. All three were led by James Studnicki, who works for The Charlotte Lozier Institute, a research arm of Susan B. Anthony Pro-Life America. The publisher said the retractions were based on various problems related to the studies’ methods, analyses, and presentation, as well as undisclosed conflicts of interest.
Two of the studies were cited by anti-abortion groups in their lawsuit against the Food and Drug Administration (Alliance for Hippocratic Medicine v. FDA), which claimed the regulator’s approval and regulation of mifepristone was unlawful. The two studies were also cited by District Judge Matthew Kacsmaryk in Texas, who issued a preliminary injunction last April to revoke the FDA’s 2000 approval of mifepristone. A conservative panel of judges for the 5th Circuit Court of Appeals in New Orleans partially reversed that ruling months later, but the Supreme Court froze the lower court’s order until the appeals process had concluded.
Mifepristone, considered safe and effective by the FDA and medical experts, is used in over half of abortions in the US.
Criticism
Amid the legal dispute, the now-retracted studies drew immediate criticism from experts, who pointed out flaws. Of the three, the most influential and heavily criticized is the 2021 study titled “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015” (PDF). The study suggested that up to 35 percent of women on Medicaid who had a medication abortion between 2001 and 2015 visited an emergency department within 30 days afterward. Its main claim was that medication abortions led to a higher rate of emergency department visits than surgical abortions.
Critics noted a number of problems: The study looked at all emergency department visits, not only visits related to abortion. This could capture medical care beyond abortion-related conditions, because people on Medicaid often lack primary care and resort to going to emergency departments for routine care. When the researchers tried to narrow down the visits to just those related to abortion, they included medical codes that were not related to abortion, such as codes for ectopic pregnancy, and they didn’t capture the seriousness of the condition that prompted the visit. Medication abortions can cause bleeding, and women can go to the emergency department if they don’t know what amount of bleeding is normal. The study also counted multiple visits from the same individual patient as multiple visits, likely inflating the numbers. Last, the study did not put the data in context of emergency department use by Medicaid beneficiaries in general over the time period.
In contrast to Studnicki’s study, the American College of Obstetricians and Gynecologists notes that studies looking at tens of thousands of medication abortions have concluded that “Serious side effects occur in less than 1 percent of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3 percent of patients. The risk of death is almost non-existent.”
Re-review
Upon receiving a complaint about the quality of Studnicki’s 2021 study, Sage began a review, asking an independent reviewer with statistical expertise to look it over. The reviewer found two of the study’s data figures misleading. “[T]he article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” Sage wrote in its retraction notice.
Sage also looked into the concern that the authors had conflicts of interest—finding that they did. All but one of the study’s authors were linked to one or more anti-abortion advocacy organization, despite that they all had declared no conflicts of interest when they submitted the article for publication or in the article itself, Sage noted. Moreover, one of the peer-reviewers—tasked with reviewing the study manuscript and deciding if it was worthy of publication—was also associated with the Charlotte Lozier Institute at the time of the review. Sage determined that the peer review process was compromised and noted that the same reviewer also reviewed two other studies led by Studnicki—the two other studies Sage retracted, one published in 2022 and the other in 2019.
The 2022 study is the other study referenced in the mifepristone legal cases, titled “A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization.” This study also had problems with its methodology and conflicts of interest, Sage found.
In all, Sage had two subject-matter experts start a fresh peer review for all three of the studies and concluded they should all be retracted. In the retraction notice, Sage summarized the findings:
In the 2021 and 2022 articles, which rely on the same dataset, both experts 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. In the 2019 article, which relies on a different dataset, both experts identified unsupported assumptions and misleading presentations of the findings that, in their opinions, demonstrate a lack of scientific rigor and render the authors’ conclusion unreliable.
Studnicki told Retraction Watch that the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He also shared a point-by-point rebuttal to findings by Sage’s reviewers.
According to reporting from the conservative news outlet, the Daily Wire, Studnicki was also removed from his position on the editorial board for the Health Services Research and Managerial Epidemiology following the decision to retract the studies late last year.