Critics warn anti-abortion groups are using ‘bogus' science to get Trump and RFK to ban widely used drugs

Independent

7 days ago

A dubious report from anti-abortion activists that casts doubt on the safety of a widely used abortion drug is now in the hands of top health officials in President Donald Trump 's administration.
Abortion rights advocates and public health researchers have roundly condemned the report as an unscientific and politically motivated attempt to undermine the drug approval process for mifepristone, commonly used in medication abortions, which make up a vast majority of all abortions in the United States.
Anti-abortion activists and influential right-wing legal groups have spent years suing the federal government in an attempt to cut off Americans' access to mifepristone, which was approved by the Food and Drug Administration more than 20 years ago.
Now, those groups appear to have launched a backdoor effort to replace the FDA's data altogether.
'This is one paper based on shoddy research methods to replace decades of safety and efficacy research,' according to Amy Friedrich-Karnik, director of federal policy for reproductive health research group the Guttmacher Institute.
'It's absolutely not legitimate for that one paper to displace decades of medical research,' she told The Independent. 'Can the FDA do it? I mean, an FDA that followed science and rigor absolutely would not do that. I think the question here is, how politicized will the FDA get?'
Last month, Trump's FDA Commissioner Marty Makary said he had no plans to change the government's position on mifepristone unless new data discovered a safety concern.
Days later, the Ethics and Public Policy Center, a right-wing think tank, released a report claiming serious complications from mifepristone use were 22 times higher than previously reported. It called on the FDA to 'further investigate the harm mifepristone causes to women' and 'reconsider its approval altogether.'
Missouri Republican Sen. Josh Hawley – whose wife, Erin Hawley, is a senior counsel with the right-wing legal advocacy group Alliance Defending Freedom, which is suing the government over mifepristone — then called on Makary to 'follow this new data.' Hawley also recently introduced legislation to 'reinstate safety regulations on the chemical abortion drug mifepristone.'
Under questions from Hawley in a Senate committee hearing this month, Health and Human Services Secretary Robert F. Kennedy Jr called the report's alleged findings 'alarming.'
'Clearly, it indicates that, at the very least, the label should be changed,' Kennedy said.
He asked Makary 'to do a complete review and to report back.'
During a Senate hearing on May 22, Democratic Sen. Patty Murray told Makary that the administration is 'laying the groundwork to rip away access to medication abortion across the country.'
This 'has not gotten enough attention, and I know you'd prefer to keep it that way,' she said.
Makary said he still has not read the center's study, which was not peer-reviewed nor published in a medical journal.
Dozens of peer-reviewed studies over the last two decades have shown that fewer than 0.5 percent of patients who take mifepristone have serious adverse reactions. The center's report claims that number is more like 11 percent.
The study, first disseminated by conservative and religious media outlets last month, was authored by a group that aims to push back against the 'extreme progressive agenda while building a consensus for conservatives.' The center was on the advisory board of Project 2025, which provided a blueprint for the Trump administration.
Its authors include the center's Director of Data Analysis Jamie Bryan Hall and President Ryan Anderson. Hall was a research fellow at The Heritage Foundation: the think tank that organized Project 2025.
Anderson is the co-author of five books, including Tearing US Apart: How Abortion Harms Everything and Solves Nothing. The pair cited the work of a 'team of data scientists, analysts, and engineers' who were assisted by their own 'clinical team of board-certified obstetricians and gynecologists.'
Members have a 'history of academic research and peer-reviewed publication,' Hall and Anderson wrote.
They claimed to have reviewed 865,727 insurance claims from women who were prescribed the drug, but the report does not disclose which database was used. According to The Washington Post, the center said the reason was tied to a confidentiality agreement with the vendor.
Public health researchers speaking to The Independent noted that the report's definition of a 'serious adverse event' could include minor side effects, including routine bleeding, unrelated sexually transmitted infections, and routine follow-up visits. The report also lists ectopic pregnancies, which do not result from mifepristone use, as serious adverse events.
Citing insurance data, they said their analysis had found 10.93 percent of women experience sepsis, infection, hemorrhaging or another 'serious adverse event' within a period of 45 days following a mifepristone abortion. 'This study is the statistical equivalent of a category 5 hurricane hitting the prevailing narrative of the abortion industry,' Anderson said in a statement.
'Calling it a study would be too generous,' said Dr. Ushma Upadhyay, a professor in the University of California-San Francisco's Department of Obstetrics, Gynecology, and Reproductive Sciences.
'The fact that it's not peer-reviewed means that a lot of the methodological flaws were not corrected or were not addressed in the paper,' she told The Independent.
In a statement to The Independent, Anderson with the Ethics and Public Policy Center said they are 'very pleased that government officials at the highest level are taking our invitation to replicate our study seriously.'
'As for the critics, most all of their criticisms are based on explicit misreadings of our paper,' he said. 'As for peer-review, what matters is not academic gate-keepers but replicability. We have made our study fully replicable for anyone who wants to analyze the insurance claims data.'
Anderson said: 'We stand behind our analysis of healthcare claims data which is why we are asking the FDA to conduct its own review of this data. Real world data in which money changed hands based on the treatment of patients and coding by doctors brings a higher level of confidence. The dataset is available for purchase and our methodology is public. This study is fully replicable, and we encourage others to replicate it. We are glad that it appears that the FDA will be doing so.'
There were 36 reports of deaths associated with mifepristone since the product was approved in September 2000, according to the FDA. Those include two cases of pregnancy outside of the womb and several cases of sepsis. 'The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions and information gaps about patient health status and clinical management of the patient,' the agency noted.
A spokesperson for GenBioPro, the manufacturer of mifepristone, said the report is 'clearly flawed.'
'If this study isn't recognized widely for what it is – just another attempt by the anti-abortion movement to spread misinformation about the safety of the abortion pill using a bogus and biased study – Americans will be left with misleading information when they need to make critical health care and life decisions,' Emma Thomas told The Independent in an email.
'This is a report with no peer review, no transparency of methods. It comes out, and within days is cited at our highest levels of government to the person who makes decisions around regulation of medications,' said Heidi Moseson, a senior research scientist at Ibis Reproductive Health.
'And that suggests a very different pipeline of the way information is traveling with sort of egregious political motivation,' she told The Independent.
A medication abortion typically involves a two-part protocol: mifepristone, which blocks the hormone progesterone to stop a pregnancy from growing, followed by misoprostol, which helps the uterus contract. The medication is also frequently used for miscarriage treatment.
Mifepristone was first approved for use by the FDA in most cases in 2000, and the drug is approved for use up to 10 weeks of pregnancy. A vast majority of all abortions occur within the first nine weeks of pregnancy. Roughly 63 percent of all abortions in the United States are medication abortions, the Guttmacher Institute says.
From 2019 through 2020, nearly 93 percent of all abortions were performed before the 13th week, according to the Centers for Disease Control and Prevention.
In 2021, the FDA under President Joe Biden permanently lifted the in-person requirement for medication abortion prescriptions, allowing patients to access the drugs via telehealth appointments and online pharmacies so patients can take the drugs at home.
In the years that followed, anti-abortion state legislators filed more than 100 bills to restrict access to abortion drugs, or sought to ban them altogether. After the Supreme Court overturned Roe v Wad e in 2022, more than a dozen states effectively outlawed all abortions in most circumstances.
Months after that ruling, Alliance Defending Freedom filed a federal lawsuit targeting mifepristone with a court in Amarillo, Texas, on behalf of a group of anti-abortion physicians, claiming the FDA wrongfully approved mifepristone and then improperly eliminated requirements that the drug should only be dispensed in person.
Trump-appointed District Judge Matthew Kacsmaryk, who had formerly worked as a chief counsel with right-wing Christian legal activist group First Liberty Institute, later issued a ruling to suspend the FDA's approval of the drug, but the Supreme Court unanimously rejected his decision.
Whether the FDA under the Trump administration can now simply swap underlying data with another is 'the million dollar question,' according to Upadhyay.
'As a scientist, it's really concerning and devastating to see what is meant to be a system to keep people safe and understand true health risks weaponized in this moment to further restrict people's access to really essential healthcare,' Moseson said.