Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, CA, United States.
Department of Pharmaceutical Sciences, School of Pharmacy, South University, Savannah, GA, United States.
Contraception. 2024 Jun;134:110417. doi: 10.1016/j.contraception.2024.110417. Epub 2024 Mar 16.
In 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 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 In February 2024 that study was retracted by its publisher.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.
We drew upon commonly accepted principles in responsible epidemiologic and scientific research to evaluate the methods and presentations of the data and organized our findings into themes.
We 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.
The 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of data promoted and exacerbated misinterpretations about the study's findings, resulting in substantial harm before it was retracted.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 health care in the United States, public health policies must be informed by scientific and medical literature that is comprehensive, methodologically sound, and absent any obfuscations or misrepresentations.
Studnicki 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 While the study has now been retracted, it led to irrevocable harm, threatening access to medication abortion, which has an established safety record.
2022 年 11 月，反堕胎倡导组织“希波克拉底医学联盟”（Alliance for Hippocratic Medicine）对美国食品和药物管理局（FDA）提起诉讼，对米非司酮最初于 2000 年获得批准及其随后的批准提出质疑，这些批准取消了对其使用的不必要限制，理由是质疑该药物的安全记录。此类挑战依赖于一项研究，该研究检查了 1999 年至 2015 年期间，使用医疗补助（Medicaid）索赔数据进行米非司酮药物流产和程序性流产后急诊就诊的发生率。2024 年 2 月，该研究的出版商撤回了该研究。在本文中，我们分析了该研究中使用的数据的方法和呈现。
我们借鉴了负责任的流行病学和科学研究中的普遍接受原则，评估了数据的方法和呈现，并将我们的发现组织成主题。
我们发现该研究存在多个方法缺陷、数据扭曲和混淆的情况，包括使用误导性的研究问题和框架、分析缺陷、对感兴趣的结果使用未经验证的替代测量、以及对数据的不适当和欺骗性可视化。在每一种情况下，由此产生的效果都混淆和歪曲了米非司酮药物流产的安全性。
数据的歪曲和夸大，以及对研究结果的夸大和夸大，导致在撤回之前对该研究结果产生了严重的误解。鉴于正在进行的司法程序威胁到美国常规生殖健康护理的可及性，公共卫生政策必须以全面、方法可靠且不存在任何混淆或歪曲的科学和医学文献为依据。
Studnicki 等人对堕胎后急诊就诊的研究通过多次出现方法缺陷和数据混淆，歪曲了米非司酮的安全性。虽然该研究现已被撤回，但它导致了不可挽回的伤害，威胁到药物流产的可及性，而药物流产已有既定的安全记录。
