Unpacking the flawed science cited in the Texas abortion pill ruling

A Texas judge’s decision to invalidate federal approval of a key abortion drug cites research based on anonymous blog posts, cherry picks statistics that exaggerate the negative physical and psychological effects of mifepristone, and ignores hundreds of scientific studies attesting to the medication’s safety.

The unprecedented ruling last week by U.S. District Judge Matthew Kacsmaryk contradicted the recommendations of numerous medical groups when it assailed the safety of mifepristone, a two-decade-old medication used in more than half of all abortions in the United States. Another federal judge determined on the same day that the drug should remain available in a swath of states.

Kacsmaryk wrote in his decision that “the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions” and accused the Food and Drug Administration of acquiescing to “the pressure to increase access to chemical abortion at the expense of women’s safety.”

A federal appeals court ruled late Wednesday that mifepristone could remain available for now, while simultaneously making the drug more difficult to access. But the panel agreed with Kacsmaryk’s assertion that the FDA did not examine certain relevant safety data, leaving the door open legally, experts say, for any previously approved drug to be yanked off the market.

The Biden administration said Thursday that it would immediately ask the Supreme Court to intervene.

Kacsmaryk’s ruling is the first time a court has suspended a medication’s approval after rejecting the assessment of a human drug by the FDA, considered among the world’s most stringent regulators. The agency says that between 2000, when the drug was approved, and last June, it received reports linking mifepristone to 28 deaths out of the 5.6 million who have used the drug. And in those 28 deaths, the agency said information gaps made it impossible to directly attribute the cause to mifepristone; in some cases, the deaths involved overdoses and coexisting medical conditions.

“If it were just up to the science, this case would be thrown out,” said Daniel Grossman, an obstetrician and gynecologist who directs a reproductive health research program at the University of California at San Francisco. The program, like many mainstream medical groups, supports abortion rights. “We have over two decades of science showing how safe this is.”

In the days since Kacsmaryk’s ruling, the scientific community has raised alarms about increasing legal and political attempts to undermine the science that informs modern medicine. Kacsmaryk, a Trump judicial appointee, is presiding over another lawsuit by anti-vaccine advocates who accuse media companies, including The Washington Post, of colluding to censor their views on coronavirus vaccines and treatments.

In the abortion pill case, an author of a Finnish study cited by Kacsmaryk, who summarized it as revealing that the “overall incidence of adverse events is ‘fourfold higher’ in chemical abortions when compared to surgical abortions,” disputed the judge’s characterization of the research.

[Justice Department will ask Supreme Court to put abortion pill limits on hold]

Plaintiffs in the lawsuit had also highlighted the study, which compared the records of more than 40,000 women in Finland who had surgical or medication abortions in the early 2000s.

The study identified a higher risk of adverse events among patients undergoing medication abortions compared with those who had surgical abortions, but the judge’s analysis neglects a crucial point: Significant complications were extremely low in both groups. In Finland, adverse events largely reflect patients concerned about uterine bleeding associated with medication abortions, said Oskari Heikinheimo, a professor of obstetrics and gynecology at the University of Helsinki and a co-author of the study.

Heikinheimo said in an interview that the plaintiffs - and now the judge - were purposely misunderstanding his work and overemphasizing “adverse events” despite overwhelming scientific evidence of the drug’s safety and the study itself noting the rarity of serious complications. No one who filed the lawsuit had contacted him to talk about his research, Heikinheimo said.

“The political game has nothing to do with the scientific process,” he said.

Because individual studies often produce conflicting results, the medical community has long relied on a systematic approach known as evidence-based medicine, drawing on accumulated evidence from clinical research to inform their care of patients. Among the hundreds of clinical trials using mifepristone over two decades, more than 400 were randomized controlled studies, which are considered the gold standard of research design.

Kacsmaryk instead peppered his ruling with data from researchers affiliated with the Charlotte Lozier Institute, an Arlington, Va.-based antiabortion group whose website proclaims its mission to “expose the harms of the FDA’s current abortion pill policy that simply ignores the known risks.”

One study by James Studnicki, director of data analytics at the Lozier Institute, found that more than a quarter of women on Medicaid who had used abortion pills between 1999 and 2015 visited an emergency room within 30 days. Critics say the study is flawed because it did not specify the services people received at the ER. Medicaid patients are more likely to visit emergency rooms for routine medical care because they often lack primary care providers.

Studnicki, in an interview, accused abortion rights groups of underplaying the potential complications from abortions involving mifepristone, noting that ER visits are serious matters.

Bleeding is a normal part of a medication abortion, but women will often visit an emergency room as a precaution because they are unsure whether the amount of bleeding is excessive - and because their abortion clinic may be very far away, said Ushma Upadhyay, a UCSF professor and expert in reproductive health and abortion safety.

Upadhyay said the Lozier Institute is known for categorizing any complaint or side effect as a “complication.”

“They blur the lines,” she said. “They’re not using medically endorsed definitions.”

An analysis by the American College of Obstetricians and Gynecologists of hundreds of published studies found that “serious side effects occur in less than 1% of patients, and major adverse events - significant infection, blood loss, or hospitalization - occur in less than 0.3% of patients.”

“The risk of death is almost non-existent,” according to the group’s amicus brief, filed jointly with the American Medical Association, the Society for Maternal-Fetal Medicine and other medical organizations opposing the lawsuit. Complications from wisdom tooth removal, colonoscopy and Viagra use carry greater risk, they said.

Experts noted that most drugs on the market can cause complications, even death. The FDA, in approving a treatment, weighs the risk of the medication vs. the benefit - it does not automatically exclude drugs that have side effects, even serious ones.

“I can assure you that that approval process was both comprehensive and quite thorough and was done according to the standard procedures at FDA,” Jane Henney, who led the agency when mifepristone was approved, said during a news conference Monday. The agency had consulted clinical data, preclinical data and the manufacturing process, among other criteria, she said.

The government’s appeal Monday underscored that “serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen.”

But Christina Francis, chief executive of the American Association of Pro-life Obstetricians and Gynecologists and a plaintiff in the lawsuit, said the drug safety data used by the FDA is flawed because it relies on reporting by abortion providers - which she said was unlikely to capture the full picture of the complications following abortions.

“Those of us on the front lines are seeing women and girls coming into the ER who have been harmed,” Francis said.

Kacsmaryk also cites studies about the mental health of women who have obtained abortions that researchers criticize as misleading.

One concluded that 77 percent of women who had a “chemical abortion” reported a “negative change.” “Thirty-eight percent of women reported issues with anxiety, depression, drug abuse, and suicidal thoughts because of the chemical abortion,” Kacsmaryk wrote.

Both statistics, according to the footnotes in his ruling, came from a study based on several dozen anonymous blog posts from abortionchangesyou.com. The website is run by the Institute of Reproductive Grief Care.

Adam Unikowsky, a partner at Jenner & Block who has argued before the Supreme Court and writes a legal newsletter, pointed out that the bloggers are a self-selected group that is far from a representative sample of women who have obtained abortions.

“This is roughly like reporting a statistic that ‘83% of people are fans of Judge Kacsmaryk’ without mentioning that the entire sample consisted of posters on JudgeKacsmarykFanClub.com,” Unikowsky wrote in his newsletter.

The judge referenced another disputed study, from 2002, asserting that “women who receive abortions have a 154% higher risk of death from suicide than if they gave birth.”

The study’s authors - including David C. Reardon, an antiabortion activist and associate scholar with the Lozier Institute - say their findings could be explained by “self-destructive tendencies, depression, and other unhealthy behavior aggravated by the abortion experience.” They analyzed California Medicaid records for 173,279 women who had an induced abortion or a delivery in 1989, then linked them to death certificates between 1989 and 1997.

Critics at the American Psychological Association have argued that the California data set is too incomplete to link abortion to a higher risk of death. Reardon defended his work in an interview, claiming that “the science is irrefutable.”

“There is no evidence that abortion causes psychological harm to women,” said Brenda Major, a professor emeritus of psychology at the University of California at Santa Barbara who has led two task forces for the American Psychological Association to analyze studies on mental health and abortion.

But Kacsmaryk chose not to refer to more rigorous studies on mental health that have shown that the most common emotional response after abortion is relief, Grossman said. A well-known study by UCSF researchers of about 1,000 women who sought abortions compared people who received abortions with those who were denied them. The 10-year study found that abortion does not hurt the health and well-being of women and did not increase their rates of depression, anxiety or suicidal thoughts. Being forced to carry an unwanted pregnancy to term, on the other hand, was associated with negative health effects.

Kacsmaryk’s ruling pointed to another study that attributes women’s mental health problems directly to abortion. The 2011 meta-analysis by Priscilla K. Coleman, a retired Bowling Green State University professor of human development and family studies, included her own studies that used flawed research methods, Major and other critics said.

Coleman’s methodology and conclusions have drawn repeated criticism from fellow academics who say her research included in the 2011 paper does not distinguish mental health problems that were diagnosed before an abortion from those that occurred afterward. Coleman, a co-author in Reardon’s 2002 study, did not respond to requests for comment.

The repercussions of Kacsmaryk’s decision reach far beyond the battle over abortion. Mary Ziegler, an expert on the legal history of abortion in the United States at the UC Davis School of Law, said the disregard for FDA expertise could threaten any drug or vaccine that has already received approval.

“It shows you how important courts are going to be in undermining or undercutting the science,” she said.

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The Washington Post’s Rachel Roubein, Ann E. Marimow and Robert Barnes contributed to this report.