Source: CNN

The academic publisher Sage Publications has retracted studies used by a Texas judge in a ruling that would suspend federal approval of the abortion pill mifepristone. The retractions, Sage said, were based on unreliable data and conflicts of interest around the authors’ ties to the anti-abortion movement.

The studies were published in the Sage journal Health Services Research and Managerial Epidemiology. They are “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015” from 2021, “A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization” from 2022 and “Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges” from 2019.

The 2021 study concluded that ER visits were more likely after a medication abortion rather than a surgical abortion. The Texas judge whose ruling in April 2023 would suspend federal approval of mifepristone, US District Judge Matthew Kacsmaryk, cited this study to suggest that the groups that brought the mifepristone lawsuit had the legal right — known as standing — to bring their challenge because adverse events from medication abortion can “overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications.’ ”

The 2022 study determined that medication abortion was more likely to send people to the ER for the surgical removal of “retained products of conception” and that those who concealed the fact that they had a medication abortion were more likely to be admitted than those whose cases were misclassified as miscarriages. It also warned that patients and personnel should be made aware of the risk. Kacsmaryk cited this study to suggest that the number of adverse events from medication abortion drugs is probably under-reported.

The judge did not cite the 2019 study, which looked at the characteristics of doctors who performed abortion in Florida and whether they had hospital admitting privileges.

The US Supreme Court will hear arguments in March about mifepristone, one of two drugs commonly used in the US for a medication abortion. For now, mifepristone remains available and not subject to restrictions that Kacsmaryk and a federal appeals court have said should be imposed on its use. The high court determined in April 2023 that access to the drug would remain unchanged until the appeals process finishes.

Medication abortion is the most common form of abortion in the US, and multiple peer-reviewed studies have shown that it is highly safe and effective.

In a note from the publisher, the academic editors said Monday that “we made this decision with the journal’s editor because of undeclared conflicts of interest and after expert reviewers found that the studies demonstrate a lack of scientific rigor that invalidates or renders unreliable the authors’ conclusions.”

Sage said that “Upon submission, the lead author declared no conflicts of interest and all authors declared the same within each article; however, all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists – all pro-life advocacy organizations that explicitly support judicial action to restrict access to mifepristone.”

Sage said it was made aware of the potential problems when a reader reached out after the 2021 study was published, it said. The reader said they had concerns that some of the data used to draw the study’s conclusions was misleading and pointed out the authors’ affiliation with the anti-abortion movement.

Sage asked outside experts to review the research that was the foundation for these studies. The independent experts concluded that the 2021 study and a 2022 paper that relied on the same data had invalid conclusions based on the way the study was designed, “unjustified or incorrect” assumptions about its facts, errors in the authors’ analysis of the data and “misleading presentations of the data.”

The experts concluded that the 2019 study, which used a different dataset, also contained misleading presentations of the findings that “demonstrate a lack of scientific rigor and render the authors’ conclusions unreliable.”

Sage, an independent publisher of more than 1,000 journals, said it prioritizes “academic integrity free from the pressures of shareholders, and, while upholding editorial independence, work with our journal editors to achieve high standards of scientific rigor and integrity. When we become aware that those standards have not been met, we take seriously our responsibility to investigate and correct the academic record when necessary.”

In a statement emailed to CNN, Jim Studnicki, the lead author of the studies and vice president at the Charlotte Lozier Institute, said authors “fully complied with Sage’s conflict disclosure requirements,” and that funding and organizational affiliations were reported.

In an email to CNN, Sage said that the way the conflict of interest disclosure works when an author submits a manuscript for consideration, is that the authors fill out a submission form that includes a question that explicitly asks about “potential or perceived conflicts of interest.”

“For each of the three retracted articles, in response to this question, the lead author declared there were ‘no’ potential or perceived conflicts of interest,” a spokesperson for Sage said and added that a decision to retract the studies was made only after expert reviewers found that the studies’ conclusions were “unreliable.”

Sage said another reason that the studies were retracted is because of a conflict of interest with one of the peer reviewers. When journals publish research, the work is supposed to be reviewed by experts with no conflict of interest, but these articles were reviewed by a researcher who, at the time, also had an affiliation with the Charlotte Lozier Institute, according to Sage. CLI told CNN that it was Sage that picked the reviewers. “It is entirely the responsibility of the journal, not CLI,” Studnicki’s statement said.

Sage said in an email to CNN that its discovery of the original peer reviewers’ conflict of interest led to a new review by independent subject matter experts. “Our process followed guidelines set forth by the Committee of Publication Ethics (COPE).”

Studnicki also disagreed with the publisher’s claims about the data. “To date, Sage has advanced no valid objection to their findings and shown no evidence of any major errors, miscalculations, or falsehoods,” the email said. CLI posted a rebuttal online.

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