Abstract

ObjectiveIn November 2022, the anti-abortion advocacy group, Alliance for Hippocratic Medicine filed a lawsuit against the U.S. Food and Drug Administration challenging the initial 2000 approval of mifepristone and its subsequent approvals, which removed unnecessary restrictions on its use, by disputing the medication’s safety record. Such challenges relied on a study examining the incidence of emergency room (ER) visits following medication abortion with mifepristone and procedural abortion using Medicaid claims data from 1999–2015. In February 2024 that study was retracted by its publisher. In this paper, we analyzed the methods and presentations of the data used in the study. Study DesignWe drew upon commonly accepted principles in responsible epidemiological and scientific research to evaluate the methods and presentations of the data and organized our findings into themes. ResultsWe found multiple instances of methodological flaws, mischaracterizations, and obfuscations of data in this study, including use of a misleading research question and framing, analytic flaws, inappropriate use of an unvalidated proxy measure for outcomes of interest, and inappropriate and deceptive visualizations of data. In each instance, the resulting effect obfuscated and misrepresented the safety of medication abortion with mifepristone. ConclusionThe misrepresentation and exaggeration of data promoted and exacerbated misinterpretations about the study’s findings, resulting in substantial harm before it was retracted. Recognizing that ongoing judicial proceedings threaten access to conventional reproductive healthcare in the US, public health policies must be informed by scientific and medical literature that is comprehensive, methodologically sound, and absent any obfuscations or misrepresentations. ImplicationsStudnicki et al’s study of emergency room visits after abortion misrepresented the safety of mifepristone with multiple instances of methodological flaws and obfuscations of data. While the study has now been retracted, it led to irrevocable harm, threatening access to medication abortion which has an established safety record.

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