Pro-life pregnancy centers are fighting Democratic attorneys general in court for the right to tell women they may be able to reverse chemical abortions by taking supplemental progesterone, a natural pregnancy hormone, to prevent mifepristone from binding to pregnancy receptors. New York's Letitia James is now trying to overturn an injunction against her.

Texas Republican AG Ken Paxton secured a $100,000 judgment against a New York doctor for telehealth prescriptions of mifepristone to Texas residents, who can't get it legally in the Lone Star State, but the Empire State refused to enforce the judgment under its shield law.

A more fundamental, and polarizing, question remains: How safe is mifepristone?

Food and Drug Administration Commissioner Marty Makary may have spoken too soon when he told the Semafor World Economy Summit last week he has "no plans" to restrict pregnancy-ending mifepristone, which must be followed by misoprostol to expel the aborted fetus, in light of new research on severe adverse events following chemical abortion.

"The real-world rate" of these complications following mifepristone is just under 11%, especially emergency-room visits (4.73%), hemorrhage (3.31%) and "repeated (surgical) abortion" to correct an incomplete chemical abortion (2.84%), according to data analysis from an "all-payer insurance claims database" of 865,727 mifepristone abortions from 2017 to 2023.

More than half are described as "other abortion-specific complications" (5.68%), followed by specific conditions: infection (1.34%), hospitalization (0.66%), ectopic pregnancy (0.35%), "other life-threatening adverse events (cardiac, pulmonary, thrombosis, anaphylaxis, surgery)" (0.22%), transfusion (0.15%) and sepsis (0.10%). 

The study was released Monday by the Ethics and Public Policy Center, which said the 11% rate is adjusted for some women suffering multiple categories of adverse events. 

The Foundation for Restoration of America released its own review of the same data set Monday, reaching "concurring conclusions" with those of EPPC, a spokesperson for FFROA told Just the News. Its findings are less detailed, though, and its PDF review is dated April 25.

One-in-10 women suffering severe adverse reactions is a sharp contrast to the FDA's black-box warning on mifepristone – added 20 years ago following three deaths and five cases of serious but nonfatal bacterial infections, for a drug that was approved just four years prior – which claims less than 0.5% of women reported serious adverse reactions in clinical trials.

The agency didn't answer Just the News queries Monday for Makary's response to the new research and why he would so quickly state publicly that he doesn't plan to change mifepristone's access.

Why not investigate Tylenol too?

Much like Louisiana GOP Sen. Bill Cassidy pressured Jay Bhattacharya at his National Institutes of Health confirmation hearing to not study any potential connection between vaccination and autism, Democratic senators pressured Makary at his hearing to rule out scientific research that could change mifepristone's access.

Makary reminded Wisconsin's Tammy Baldwin that the FDA applied a "Risk Evaluation Mitigation Strategy" to mifepristone in 2019, which the Biden administration updated three times. It requires "ongoing data collection, so I can't prejudge that data without looking at it," he said, such as a hypothetical "drug-drug interaction" that would prompt an FDA warning.

Baldwin invoked the Planned Parenthood talking point that mifepristone and Tylenol have similar safety profiles, dismissing Makary's protest that Tylenol doesn't have a REMS. 

The FDA's black-box warning cites studies that found 2.9-4.6% of women go to the ER following mifepristone, 2-7% of them "will need a surgical procedure" because it didn't work correctly, and its failure rate is 7% between nine and 10 weeks' gestation.

New Hampshire's Democratic Senator Maggie Hassan claimed there were "lots and lots of data" for the safety and efficacy of mifepristone and asked whether Makary would "unilaterally overrule the data that currently exists for political purposes and for political reasons." 

He responded: "I have no preconceived plans to make changes to the mifepristone policy."

Makary gave a similar answer at the Semafor summit – whose advisory board includes Pfizer CEO Albert Bourla – when PBS News Hour co-anchor Amna Nawaz pressed him. 

"I have no plans to take action on mifepristone" but "I believe as a scientist you gotta evolve as the data comes in," he said, and if "the data suggests something or tells us that there's a real signal, we can't promise we're not going to act on that data that we have not yet seen."

Nawaz responded incredulously that "decades" of data prove mifepristone is "overwhelmingly safe and effective," asking whether Makary would really ignore the "precedent" of earlier data.

Makary's "no plans" pledge earned quick disapproval from Sen. Josh Hawley, R-Mo., who called it "exceptionally disappointing." 

Semafor noted his wife argued a challenge to the FDA's authority to loosen access rules for mifepristone, including mail order without an in-person doctor's visit, at the Supreme Court, which ruled 9-0 the plaintiffs didn't have legal standing last summer.

Conservative estimate because database is missing some categories

FFROA reached out to Just the News with its study Monday morning, and Susan B. Anthony Pro-Life America promoted both EPPC and FFROA studies two hours later, prompting confusion on whether they were working together. 

Each review group told Just the News their efforts weren't related but used the same data, and FFROA said it "commissioned the study."

SBA Pro-Life America said the results reaffirm findings from the pro-life Charlotte Lozier Institute, published last year in the International Journal of Epidemiology and Public Health Research. The institute's scientists are suing Sage Publishing under California law for retracting their earlier abortion-pill research paper.

EPPC said its team purchased access to the database, which covers "private health insurance, Medicaid, Medicare, TRICARE, and the Department of Veterans Affairs." The dataset "provides longitudinal tracking of medical diagnoses, procedures, and prescriptions for each patient and is widely used in academic and regulatory research."

The estimated 11% severe adverse reaction rate is conservative because the database excludes "transactions for which the insurer is also the provider (as is the case with some [health maintenance organizations] and much VA care), as well as cash pay transactions (which are disproportionately common for abortion)," EPPC said.

The research was "conducted and validated by a team of data scientists, analysts, and engineers, with assistance from our clinical team of board-certified obstetricians and gynecologists," some of whom "have a history of academic research and peer-reviewed publication," EPPC says.

Restoration, whose parent organization also has a political action committee and projects on voter rolls and "fair courts," said its "clinical team of board-certified obstetrician-gynecologists" reviewed the database. 

Chemical abortions rose from about 92,000 in 2017 to more than 154,000 in 2023, the year after the Supreme Court returned abortion regulation to the states, and the serious adverse event rate rose from 9.6% to as high as 12.2% in 2022, it found.

California alone made up more than half of chemical abortions in the data set, which FFROA said represents a quarter of U.S. chemical abortions, based on the abortion industry's Guttmacher Institute estimates. The next most happened in New York, Illinois, Washington State, New Jersey, Minnesota, Maryland and Massachusetts.

Neither study identifies who actually reviewed the data or suggests the research will be submitted to peer-reviewed publications.

The EPPC spokesperson said the center doesn't plan to submit its study for peer review, but its "methodology is public and the data we use can be accessed by anyone willing to purchase it. We encourage others to replicate our study for themselves."

It will not "make public every individual who supported this effort for their safety," he said. The listed authors are EPPC President Ryan Anderson and Director of Data Analysis Jamie Bryan Hall.

"Everyone saw the threats issued against members of the Supreme Court following the Dobbs decision," the spokesperson said. "The other individuals who assisted in this study are not high-profile individuals with personal security details, so I believe it's understandable as to why we would protect their identities."