番茄社区

Sage Journals retracted three abortion studies -- including two cited by a federal judge in a case against the abortion pill mifepristone (Mifeprex) -- after an investigation revealed methodological flaws and misleading conclusions.

In the , Sage stated that an investigation following concerns raised by a reader about one article revealed that the way some data are presented "leads to an inaccurate conclusion" and that its study cohort "has problems that could affect the article's conclusions."

Subsequently, the journal conducted post-publication peer review of two more studies involving similar author groups that relied on the same dataset, and 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."

All three retracted articles had been published in the journal Health Services Research and Managerial Epidemiology and were led by James Studnicki, ScD, MPH, MBA, the vice president and director of data analytics at the Charlotte Lozier Institute, the Arlington, Virginia-based research arm of Susan B. Anthony Pro-Life America.

"Sage confirmed that all but one of the article's authors had an affiliation with one or more of [the] Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists [AAPLOG], all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself," . AAPLOG is one of the partnering organizations of the Alliance for Hippocratic Medicine, which is the plaintiff in the case against the FDA's approval of mifepristone.

In an emailed statement, Studnicki told 番茄社区 that "all authors fully complied with Sage's conflict disclosure requirements. They reported their organizational affiliations, as well as [Charlotte Lozier Institute] funding of the study, as part of the submission for publication."

"In fact, the ER study includes 10 mentions of [the Charlotte Lozier Institute] and the authors' professional status or relationship there. There is nothing that we were required to report that we did not report," he said.

During the investigation, Sage also found that one of the people who peer reviewed the research prior to original publication was also associated with the Charlotte Lozier Institute. Thus, Sage determined that under Committee of Publication Ethics (COPE) standards, the initial peer review was "unreliable."

The retracted studies are:

• "A longitudinal cohort study of emergency room utilization following mifepristone chemical and surgical abortions, 1999–2015" ()
• "A post hoc exploratory analysis: Induced abortion complications mistaken for miscarriage in the emergency room are a risk factor for hospitalization" ()
• "Doctors who perform abortions: Their characteristics and patterns of holding and using hospital privileges" ()

Two of the studies were Matthew J. Kacsmaryk in his ruling that first upended the FDA's more than 20-year approval of mifepristone (Mifeprex), which is used in medication abortion regimens. One of the studies was used to support Kacsmaryk's argument that the plaintiff's case had legal standing. That case, FDA v. Alliance for Hippocratic Medicine, will be heard by the Supreme Court on March 26, according to .

Last week, more than 300 reproductive health researchers urging the Supreme Court to support the "clear, abundant, and plainly sufficient scientific record supporting FDA's decision-making" in the case challenging mifepristone. Ushma Upadhyay, PhD, MPH, a professor at Advancing New Standards in Reproductive Health (ANSIRH) at the University of California San Francisco, was one of those signatories.

"In the wake of this retraction, we call upon the high court to follow the clear science before them and strike down any attempts to roll back advancements in medication abortion," she said in a written statement.

The American College of Obstetricians and Gynecologists' is that "the overwhelming weight of scientific evidence has conclusively demonstrated that mifepristone is safe and effective."

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