Abortion opponents are coming for mifepristone using what medical experts call ‘junk science'

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2 days ago

Packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023, in Rockville, Maryland. (Photo illustration by)
Using flawed studies and scientific journal publications, abortion opponents are building a body of research meant to question the safety of the abortion pill mifepristone, a key target for the movement.
The effort comes as federal officials have expressed a willingness to revisit the drug's approval — and potentially impose new restrictions on a medication used in the vast majority of abortions.
This report was originally published by The 19th. The Illuminator is a founding member of the 19th News Network.
Mainstream medical researchers have criticized the studies, highlighting flaws in their methodology and — in the case of one paper published by the conservative think tank Ethics and Public Policy Center (EPPC) — lack of transparency about the data used to suggest mifepristone is unsafe. The vast body of research shows that the drugs used in medication abortion, mifepristone and misoprostol, are safe and effective in terminating a pregnancy.
'There's a proliferation of anti-abortion propaganda right now. I think it is a coordinated attack on mifepristone,' said Ushma Upadhyay, an associate professor at the University of California, San Francisco who studies medication abortion.
Released in April, the EPPC paper suggests that mifepristone results in serious adverse events for 1 in 10 patients — substantially higher than the widely accepted figure of .3 percent complication rate most research has attributed to the pill. The paper appears to count what other researchers say are non-threatening events, such as requiring follow-up care to complete the abortion, or visiting an emergency room within 45 days of an abortion — even if the patient did not end up requiring emergency care — as serious adverse effects. That paper also did not go through peer review, a standard process for scientific research in which other scholars review a study's findings and methodology before it can be published.
Another paper, a commentary piece published this week in the journal BioTech, challenges the commonly cited statistic that mifepristone has a lower complication rate than acetaminophen, or Tylenol, tracing the history of the comparison and arguing that it is mathematically flawed. The paper's author, Cameron Loutitt, is a biomedical engineer by training and director of life sciences at the Charlotte Lozier Institute, a research arm of the anti-abortion group SBA Pro-Life America.
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'My hope is that this paper sparks action in my peers in the research and medical community to more critically evaluate these unfounded claims regarding abortion drug safety,' Loutitt said in a statement.
Days later, a group of researchers from the institute published another study, this one arguing that emergency rooms are likely to identify medication abortions as miscarriages, which they say increases the risk of needing hospital care.
A miscarriage and a medication abortion are medically indistinguishable, and patients will sometimes visit an emergency room to ensure the drugs worked, or if they suspect possible complications. In places where abortion is illegal, patients may also tell health care providers they experienced a miscarriage to minimize their legal risk. Studies like the Lozier Institute paper suggest complications from medication abortions are being undercounted.
That study was rejected by another journal on April 12 before being published this week, noted Upadhyay, who had served as a peer reviewer in that rejection process. A similar paper written by many of the same researchers behind the Lozier Institute's was retracted a year ago by the journal that published it, along with two others suggesting mifepristone was unsafe.
'They keep trying to publish the same junk science,' Upadhyay said.
James Studnicki, the Charlotte Lozier Institute's director of data analytics, who led the second of its new anti-abortion papers and the study retracted last year, did not respond to a request for comment. But a spokesperson for the institute said the organization is challenging last year's retraction through an arbitration process. This March, Studnicki said in a statement that the retraction placed 'politics over publication ethics.'
These studies and papers all fall outside the scientific consensus. More than 100 studies over decades of research have found that mifepristone — and the medication abortion regimen as a whole — has a low complication rate and is very safe to use for abortions. Papers like these aren't new, and their scientific accuracy has long been questioned. But the bevy of new reports and analyses comes at a moment when abortion opponents may have more influence in shaping public policy.
Mifepristone restrictions are a top priority for the anti-abortion movement. About two-thirds of all abortions in the United States are now done using medication. Even in states with abortion bans, pregnant people have increasingly turned to abortion medication, which they receive from health providers in states with laws protecting abortion.
Nationwide, about 1 in 5 abortions are now performed using telehealth; almost half of those are for people in states with bans or restrictions. Mifepristone is currently approved for use through 10 weeks of pregnancy.
Health and Human Services Secretary Robert F. Kennedy Jr. testified before a Senate committee that he has directed the Food and Drug Administration to review the approval of mifepristone, citing the EPPC paper specifically. Jim O'Neill, who is nominated for a deputy secretary role, has also said he is in favor of a 'safety review' of the drug — a move that could result in new restrictions on how it is prescribed.
Meanwhile, physicians and researchers are highlighting the rigor of the FDA approval process.
'FDA approval of mifepristone must reflect the rigorous clinical evidence that has proven unequivocally that it is safe and effective for use in medication,' 13 reproductive medical organizations, including the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, said in a statement after Kennedy indicated the drug may undergo a new FDA review. 'Mifepristone has been used for decades for abortion and miscarriage management by millions of patients, and complications are exceedingly rare, minor, and most often easily treatable.'
The International Institute for Reproductive Loss, an anti-abortion nonprofit, has explicitly prioritized the publication of research that supports restrictions on medication abortion. Presenting at an anti-abortion conference last September, that organization's science director, Priscilla Coleman, highlighted strategies that she said could help result in the retraction of studies showing mifepristone's safety, such as finding 'agenda-driven, poorly developed and conducted studies published in peer-reviewed journals' and writing to journal editors. Coleman did not respond to a request for comment.
Though no scientific consensus has changed, anti-abortion lawmakers have rallied around the suggestion that complications are common. In a private Zoom meeting reported on by Politico, abortion opponents cited the EPPC paper as a potential tool to justify further restrictions on mifepristone — even while acknowledging that the report is 'not a study in the traditional sense' and 'not conclusive proof of anything.'
Sen. Josh Hawley, a Republican from Missouri, cited the EPPC paper in a letter to FDA Commissioner Marty Makary, who had only a day before the report's publication indicated openness to reviewing mifepristone's approval if new evidence emerged.
'The time to act is now. It is time to revisit and restore the FDA's longstanding safety measures governing mifepristone,' Hawley wrote. His office did not reply to a request for further comment.
'They're producing this terrible 'science' because they don't have any real science that backs them up. And all they've gotten from the administration is, 'Yeah, we'll study it,'' said David Cohen, a law professor at Drexel University who has advised state legislatures on crafting abortion-protetctive laws.
Through the courts and Trump administration, abortion opponents have pushed to reverse a 2021 FDA decision allowing mifepristone to be distributed via telehealth. In addition to calling for the in-person requirement to be reinstated, abortion opponents are asking for restrictions such as the dispensation of the drug to require three in-person visits, and for mifepristone to only be approved for use only in the first seven weeks of pregnancy. Many have also argued the drug should be taken off the market entirely.
The Trump administration said on the campaign trail that it would leave abortion policy up to the states. So far, there has been little indication from the federal government that such changes are imminent.
'Pills are kind of just spreading, as we predicted, without almost any restriction and so far the anti-abortion movement hasn't figured out what to do,' Cohen said.
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This story was originally reported by Shefali Luthra of The 19th. Meet Shefali and read more of her reporting on gender, politics and policy.