Introduction

In a recent development, two pivotal studies that have been heavily relied upon by both plaintiffs and judges in arguments to restrict or remove medication abortion from the market have been retracted by academic publisher Sage. The decision to retract these studies was made due to the discovery of undisclosed conflicts of interest and the unreliable nature of the findings.

Background

Last year, States Newsroom was the first to report on the investigation launched by Sage into the research showcased prominently in the initial Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration case. This case, which is scheduled to be heard by the U.S. Supreme Court next month, centers around the drug mifepristone, a key component of the two-drug regimen used for pregnancy termination and miscarriage management.

Retraction of Studies

Sage has officially retracted three studies that were published in their journal “Health Services Research and Managerial Epidemiology.” These studies were funded and produced by the Charlotte Lozier Institute, the research arm of the influential Susan B. Anthony Pro-Life America organization. This organization actively works to elect anti-abortion lawmakers at both federal and state levels.

Following the guidelines set by the Committee on Publication Ethics (COPE), Sage made the decision to retract these studies in collaboration with the journal’s editor. Expert reviewers determined that the studies lacked scientific rigor and contained unreliable findings, thereby invalidating the authors’ conclusions.

The Retracted Studies:

• “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)

James Studnicki, the vice president and director of data analytics at the Charlotte Lozier Institute, served as the lead author for all three studies. Notably, Studnicki was a member of the editorial board of “Health Services Research and Managerial Epidemiology” at the time these studies were published.

Despite declaring no conflicts of interest upon submission, it was discovered that all but one of the article’s authors had affiliations with one or more of the pro-life advocacy organizations, including the Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists. These organizations explicitly support judicial action to restrict access to mifepristone. The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) is one of the plaintiffs in the Alliance v. FDA lawsuit.

Neither Studnicki nor the Charlotte Lozier Institute has responded to requests for comment at the time of publishing.

Critical Examination of the Studies

Pharmaceutical sciences professor Chris Adkins raised concerns about the 2021 “Longitudinal Cohort Study” to Sage last year. This study was cited by U.S. District Judge Matthew Kacsmaryk as evidence that anti-abortion doctors had standing to sue, claiming that adverse events from chemical abortion drugs overwhelmed the medical system. Adkins expressed doubts about the study’s conclusions and the possible intent to deceive.

An independent post-publication peer review conducted by epidemiology and public health experts supported Adkins’ concerns. The review highlighted fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in data analysis, and misleading presentations of the data in both the 2021 and 2022 papers. The experts also found unsupported assumptions and unreliable conclusions in the 2019 article, which utilized a different dataset.

Mifepristone’s Safety and Efficacy

Experts in the field have repeatedly emphasized the safety and efficacy of mifepristone, with over 5.6 million documented uses of the drug over the past two decades. The U.S. Food and Drug Administration (FDA) has recorded 28 deaths; however, the FDA has not identified mifepristone as the cause of these deaths.