Studies cited in case over abortion pill are retracted due to flaws and conflicts of interest
A medical journal has retracted two studies claiming to show harm from the abortion pill mifepristone, citing the authors’ conflicts of interest and shortcomings in their research.
Two of the three studies retracted by medical publisher Sage Perspectives were cited in a pivotal Texas court ruling that threatened access to the pill. The U.S. Supreme Court will hear the case next month, with a ruling expected later this year. The court’s ruling could affect access to mifepristone nationwide, as well as whether it is still available by mail.
Medication abortion accounts for more than half of all abortions in the US, usually involving two medications: mifepristone and misoprostol.
Here’s what you need to know about the withdrawals:
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 wants to end access to abortion.
A 2021 article looked at 423,000 abortions and more than 121,000 emergency room visits after medication abortions and abortions performed through a medical procedure between 1999 and 2015. Researchers concluded that medication abortions are “consistently and progressively associated with more postabortion ER morbidity” than the other type. .
A 2022 article concluded that the inability to identify a previous abortion during an emergency visit — either by a doctor or because a patient concealed it — “is a significant risk factor for subsequent hospitalization.”
HOW DO THESE STUDIES RELATE TO THE MIFEPRISTONE CASE?
U.S. District Judge Matthew Kacsmaryk cited the studies in a controversial legal ruling set to appear 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 serious safety issues with the pill were overlooked.
He cited one of the retracted studies claiming that mifepristone causes “many intense side effects.” The ruling also cited the second retracted article to explain why anti-abortion doctors had the legal standing to bring their lawsuit – instead of showing that they had been directly harmed by a product, the judge said that medical abortions “ enormous pressure and stress” for doctors.
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 approval of mifepristone in 2000 is not in dispute, but the Supreme Court could reverse recent changes that made it easier to obtain the drug, including by mail order.
WHY WERE THE STUDIES WITHDRAWAL?
In a retraction notice, Sage Perspectives said a reader had contacted the journal with concerns about the presentation of some of the data, possible “defects” in the selection of the data, and whether authors’ ties to anti-abortion organizations pose conflicts of interest that could lead to conflict of interest. should have been made public.
Sage said in a statement that it had asked two experts to conduct an independent post-publication peer review, which found that the conclusions had been “fully or partially debunked” for several reasons, including issues with the design and methodology of the research 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 vice president of the Charlotte Lozier Institute.
According to Ivan Oransky, who teaches medical journalism at New York University and co-founder of the Retraction Watch blog, the number of retractions of research articles has increased, with more than 10,000 last year. About 1 in 500 papers is withdrawn, he said, compared to 1 in 5,000 20 years ago.
WHAT DOES SCIENCE SAY ABOUT MIFEPRISTONE?
Ushma Upadhyay, a public health professor at the University of California, San Francisco, said medication abortions are extremely safe, with less than a third of 1% followed by a serious side effect. 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 study is that the authors confused ER visits with serious side effects and did not confirm whether patients received treatment.
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