Study cited by Texas judge in abortion pill case retracted

Mifepristone has more than 5.6 million uses since receiving FDA-approval over 20 years ago

By: - February 7, 2024 3:46 pm
Experts have said that mifepristone, part of a two-drug regimen, has a record of safety and efficacy in more than two decades of use.

Experts have said that mifepristone, part of a two-drug regimen, has a record of safety and efficacy in more than two decades of use. (Chris Coduto/Getty Images for UltraViolet)

Two of the key studies cited by plaintiffs and judges as evidence that medication abortion should be pulled from the market or heavily restricted have been retracted because of undeclared conflicts of interest and unreliable findings, academic publisher Sage announced this week.

States Newsroom was the first to report last year that Sage had opened an investigation into some of the research featured prominently in the initial Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration case, whose appeal goes before the U.S. Supreme Court next month. The case is centered on mifepristone, part of a two-drug regimen used to terminate pregnancies and to manage miscarriages.

Sage retracted three studies published in its journal “Health Services Research and Managerial Epidemiology,” which were funded and produced by the Charlotte Lozier Institute, the research arm of the influential Susan B. Anthony Pro-Life America, which works to elect federal and state anti-abortion lawmakers.

“Following Committee on Publication Ethics (COPE) guidelines, we made this decision with the journal’s editor because of undeclared conflicts of interest and after expert reviewers found that the studies demonstrate a lack of scientific rigor that invalidates or renders unreliable the authors’ conclusions,” reads a statement issued by Sage.

The studies are:

  • “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015” (2021)
  • “A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization” (2022)
  • “Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges” (2019)

The lead author for each study was James Studnicki, Charlotte Lozier’s vice president and director of data analytics, who was on the editorial board of “Health Services Research and Managerial Epidemiology” at the time the studies were published.

“Upon submission, the lead author declared no conflicts of interest and all authors declared the same within each article; however, all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists – all pro-life advocacy organizations that explicitly support judicial action to restrict access to mifepristone,” the Sage statement reads. One of those groups, AAPLOG, is a plaintiff in the Alliance v. FDA lawsuit.

In a statement, Studnicki and Tessa Longbons, senior research associate, called the Sage retraction a “baseless ideological attack on our scientific research and experts. To date, Sage hasn’t identified a single substantive objection to the studies to the research team. However, Sage has launched a political assault against an organization whose research has been cited in major pro-life legal victories, such as the Dobbs decision and the AHM v. FDA case. Even after reviewing and publishing this study and standing by it for years, Sage has now caved to outside partisan pressures that dominate elite circles,’’ Studnicki and Longbons said.

“Sadly, this incident points to a larger, newer phenomenon, which is, many of our scientific institutions no longer stand in defense of open inquiry. Rather, what we’re seeing is a biased faction in the medical community (that) holds all the power and attempts to suppress any research that cuts against their approved, pro-abortion narrative,’’ Studnicki and Longbons said.

Last year, pharmaceutical sciences professor Chris Adkins contacted Sage with his concerns about the 2021 “Longitudinal Cohort Study,” which was cited by U.S. District Judge Matthew Kacsmaryk as evidence that the anti-abortion doctor-plaintiffs had standing to sue 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.”

That paper looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion and concluded that medication abortion is excessively risky.

“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.

Experts have cited mifepristone’s safety and efficacy with more than 5.6 million uses over the past two decades. The FDA has recorded 28 deaths but has stated that the drug cannot be identified as the cause of those deaths.

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Sofia Resnick
Sofia Resnick

Sofia Resnick is a national reproductive rights reporter for States Newsroom, based in Washington, D.C. She has reported on reproductive-health politics and justice issues for more than a decade.

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