This week, the peer-reviewed science publisher Sage Journals retracted three controversial abortion studies, two of which have been frequently cited by plaintiffs in an upcoming case that could restrict access to the abortion pill nationwide.
One study, published in the journal Health Services Research and Managerial Epidemiology in 2021, claimed that mifepristone — one of two pills used in a medication abortion — increased the risk of women going to the emergency room following a medication abortion compared to surgical abortions. The second study concluded that people who go to the emergency room after taking mifepristone are frequently misclassified as miscarriages, suggesting that mifepristone complications are wrongfully being concealed.
U.S. District Judge Matthew Kacsmaryk, who was appointed by former President Trump, cited both studies in the April 2023 ruling that invalidated the FDA’s approval of mifepristone in the case U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.
But as experts have told Salon before, the case which is set to go in front of the U.S. Supreme Court on March 26 for oral arguments is based on “junk science.” Kacsmaryk’s ruling read like “anti-abortion talking points,” Seema Mohapatra, a health law and bioethics expert at Southern Methodist University, told Salon.
A ruling in favor of Alliance for Hippocratic Medicine, an organization of anti-abortion activists backed by the Christian right-wing lobbying group Alliance Defending Freedom, could result in eliminating access to mifepristone by telehealth and by mail, and shortening the timeframe that it could be used for in a pregnancy from 10 weeks to seven weeks. Not only will this restrict access to mifepristone in abortion ban states, but those residing in states where abortion care remains legal.
It will also, as one doctor previously told Salon, force American mothers to accept “substandard care for miscarriage management” as mifepristone is frequently used in the miscarriage management process.
In a retraction statement, Sage said the authors of the articles had undeclared conflicts of interest. Indeed, the lead author of all three studies was James Studnicki, a vice president at the Charlotte Lozier Institute, a leading anti-choice group. Sage also said that the authors used unreliable methodologies to misrepresent their conclusions.
As one social scientist pointed out to Wired, the 2021 conflated emergency department visits with serious adverse events. Since a medication abortion causes bleeding, it’s not uncommon for some people to go to the emergency room after taking the pill. Using an independent investigation after Sage issued an “expression of concern” about the 2021 paper, the journal found that the studies “demonstrate a lack of scientific rigor that invalidates or renders unreliable the authors’ conclusions,” according to the retraction statement by Sage. Studnicki gave Wired a 10-page rebuttal addressing the retractions.
Numerous amicus briefs signed by organizations representing the country's leading researchers and physicians have emphasized there is “ample scientific evidence” to support widespread use and availability of mifepristone, which the FDA approved in 200 for the medical termination of pregnancy. Indeed, the drug has a well-established safety profile. But the lawsuit filed in November 2022 bringing forth the case alleged that the longstanding approval should be revoked because it was allegedly based on incomplete data. Alliance for Hippocratic Medicine claimed that the FDA failed to protect women when it approved the drug.
As history has shown before, it only takes one discredited study to make a real-world lasting impact. In 1998, former British doctor Andrew Wakefield authored a study that turned into a claim that MMR vaccines could cause autism, prompting an international panic. But it wasn't until 2010 when The Lancet fully retracted the paper revealing that the paper was riddled with scientific errors and that the authors had many conflicts of interest. Today, the paper can still be attributed to driving a rise in measles outbreaks after being eradicated in the United States. But can revealing the flaws in these studies now cited by Kacsmaryk influence the outcomes of the Supreme Court’s ruling?
Lawyers aren’t exactly optimistic. Not because the studies didn’t hold influence, but because the case is not only about mifepristone, but it’s also about the FDA’s power and influence on medication which is simultaneously revealing flaws in the U.S. justice system.
“I don’t see these two studies being retracted being the tipping point that makes the difference with any justice moving from one camp to the other,” David S. Cohen, a professor of law at Drexel Kline's School of Law, told Salon. “For justices who already think the FDA shouldn’t be second-guessed and should be trusted to evaluate the science, this will just be further proof, and for justices who already think the FDA acted in a way unsupported by the science, they’ll find other reasons and studies, and these two won’t change anything.”
Just because the studies have been retracted, Mohapatra said, doesn’t mean that Kacsmaryk will re-issue another opinion. And his opinion is in the Federal Register. She added that it’s not uncommon for justices and the courts to seek out studies that bolster their opinions.
“I think that when the Supreme Court considers the same issue, this term, they will at least know that the studies are not to be relied upon. But I don't know if that's going to make a difference in terms of use,” Mohapatra said, adding that the fact the the Supreme Court is going to decide on the fate of a drug that has a better safety record than some over-the-counter drugs, two decades after its FDA approval, is “shocking” and could set a bad precedent. “If we start overturning, long-settled and approved medications, what's next?”
Mohapatra said this is a lesson for science journals, as more legal cases are leaning on peer-reviewed studies.
“I hope that this will make people more careful about when they cite studies, but I’m not sure it will,” she said. “I don't think that Kacsmaryk was actually going through and reading these studies.”
