A medical journal has retracted two studies claiming to show the harms of the abortion pill mifepristone, citing conflicts of interest by the authors and flaws in their research.
Two of the three studies retracted by medical publisher Sage Perspectives were cited in a pivotal Texas court ruling that has threatened access to the pill. The U.S. Supreme Court will take up the case next month, with a decision expected later this year. The court’s ruling could impact nationwide access to mifepristone, including whether it continues to be available by mail.
Medication abortion accounts for more than half of all abortions in the U.S., and typically involves two drugs: mifepristone and misoprostol.
WHAT DO THE STUDIES SAY?
Both studies cited in the court ruling were published in the journal Health Services Research and Managerial Epidemiology. They were supported by the Charlotte Lozier Institute, part of an advocacy group that seeks to end access to abortion.
A 2021 paper looked at 423,000 abortions and more than 121,000 emergency room visits following medication abortions and abortions done through a medical procedure from 1999 to 2015. Researchers concluded medication abortions are “consistently and progressively associated with more postabortion ER visit morbidity” than the other type.
A 2022 paper concluded that failure to identify a prior abortion during an ER visit — either by a doctor or because a patient concealed it — is “a significant risk factor for a subsequent hospital admission.”
HOW DO THESE STUDIES RELATE TO THE MIFEPRISTONE CASE?
U.S. District Judge Matthew Kacsmaryk cited the studies in a controversial legal ruling that will go before the U.S. Supreme Court next month.
Essentially, Kacsmaryk sided with a conservative Christian medical group, arguing that mifepristone’s original approval by U.S. regulators was flawed because it overlooked serious safety issues with the pill.
He cited one of the retracted studies in claiming that mifepristone causes “many intense side effects.” The ruling also cited the second retracted paper in explaining why anti-abortion physicians had the legal standing to bring their lawsuit — instead of showing they were directly harmed by a product, the judge said medical abortions cause “enormous pressure and stress” to physicians.Many legal experts and medical professionals were deeply skeptical of the arguments and statistics cited in Kacsmaryk’s decision, and a federal appeals court overturned parts of the ruling last summer.
The Food and Drug Administration’s original 2000 approval of mifepristone is not in question, but the Supreme Court could roll back recent changes that made the drug easier to obtain, including via mail order.
WHY WERE THE STUDIES RETRACTED?
In a retraction notice, Sage Perspectives said a reader contacted the journal with concerns about the presentation of some of the data, possible “defects” in the selection of the data and whether authors’ affiliations with anti-abortion advocacy organizations present conflicts of interest that should have been disclosed.
Sage said in a statement that it asked two experts to conduct an independent post-publication peer review, which found the conclusions “were invalidated in whole or in part” for several reasons, including problems with the study design and methodology and errors in the analysis of the data.
The studies’ lead author, James Studnicki, said in an emailed statement that the publisher’s actions are a “baseless attack on our scientific research and studies.” Studnicki is a vice president at the Charlotte Lozier Institute.
Retractions of research papers have been on the rise, with more than 10,000 last year, according to Ivan Oransky, who teaches medical journalism at New York University and co-founded the Retraction Watch blog. About 1 in 500 papers is retracted, he said, compared with 1 in 5,000 two decades ago.
WHAT DOES THE SCIENCE SAY ABOUT MIFEPRISTONE?
Ushma Upadhyay, a professor of public health at the University of California, San Francisco, said medication abortions are extremely safe, with less than a third of 1% being followed by a serious adverse event. She pointed out that mifepristone has been used for more than two decades. The FDA says it has been used by about 6 million people for abortions.
She said one of the major flaws of the retracted research is that the authors conflate ER visits with serious adverse events and don’t confirm whether patients received treatment.
