Two Key Studies Cited in Medication Abortion Case Retracted Due to Conflicts of Interest and Unreliable Findings

In a major development, academic publisher Sage announced on Monday that two key studies, which have been cited by plaintiffs and judges in the debate over medication abortion, have been retracted due to undeclared conflicts of interest and unreliable findings. These studies were prominently featured in the Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration case, which is set to be heard by the U.S. Supreme Court next month. The case revolves around mifepristone, a drug used for pregnancy termination and miscarriage management.

States Newsroom was the first to report last year that Sage had initiated an investigation into the research highlighted in the Alliance v. FDA case. The research in question was funded and produced by the Charlotte Lozier Institute, the research arm of the influential Susan B. Anthony Pro-Life America. The institute works towards electing anti-abortion lawmakers at the federal and state levels.

Sage has now retracted three studies published in its journal “Health Services Research and Managerial Epidemiology,” all of which were authored by James Studnicki, the vice president and director of data analytics at the Charlotte Lozier Institute. 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 decision to retract these studies was made in accordance with the Committee on Publication Ethics (COPE) guidelines. The studies were found to lack scientific rigor, and the authors’ conclusions were deemed invalid or unreliable after expert reviewers identified undeclared conflicts of interest.

Upon submission, the lead author of each study had declared no conflicts of interest. However, it was later discovered that all but one of the authors had affiliations with pro-life advocacy organizations such as the Charlotte Lozier Institute, the Elliot Institute, and the American Association of Pro-Life Obstetricians and Gynecologists. These organizations explicitly support judicial actions to restrict access to mifepristone. It is worth noting that the American Association of Pro-Life Obstetricians and Gynecologists is one of the plaintiffs in the Alliance v. FDA case.

In response to the retraction, James Studnicki and Tessa Longbons, senior research associate, criticized Sage for launching a “baseless ideological attack” on their scientific research and experts. They claimed that Sage had failed to provide any substantive objections to the studies and accused the publisher of succumbing to external partisan pressures.

Pharmaceutical sciences professor Chris Adkins raised concerns about the accuracy and data used in the 2021 “Longitudinal Cohort Study.” This study was cited by U.S. District Judge Matthew Kacsmaryk as evidence that doctors had standing to sue over adverse events associated with chemical abortion drugs. Adkins found that the study misrepresented its conclusions and exaggerated the risks of medication abortion.

Independent post-publication peer reviews of the retracted studies confirmed Adkins’ concerns. The experts identified fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in the authors’ data analysis, and misleading presentations of the data.

Experts have consistently highlighted the safety and efficacy of mifepristone, which has been used over 5.6 million times in the past two decades. The FDA has recorded 28 deaths, but it has stated that the drug cannot be definitively identified as the cause of these deaths.