The Bad Data Backing Josh Hawley’s Attack on Abortion Pills
The abortion pill mifepristone “is not safe and effective,” argue the authors of a new study that uses insurance claim data to examine adverse reactions to the pill. They claim to have found a “serious adverse event” rate of 10.93 percent, and they say this finding justifies renewed restrictions on mifepristone.
Sen. Josh Hawley (R–Mo.) seems to agree. The day the Ethics & Public Policy Center (EPPC) released its new mifepristone study, Hawley wrote to Food and Drug Administration (FDA) chief Marty Makary, urging the commissioner to “follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone.”
Makary said in late April that he has “no plans” to restrict access to abortion pills. But he added that “there is an ongoing set of data that is coming into FDA on mifepristone. So 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.”
Taken at face value, that’s simply a reasonable statement of scientific uncertainty. But it seems a little odd considering we have decades of data on mifepristone already—this isn’t some new or relatively unstudied drug. And things get even dicier when we consider that, a few days after Markary’s April 24 comments at the Semafor World Economy Summit, a conservative group released new data that are being used by conservative politicians to suggest it is time for the FDA to act.
The Study
Hall and Anderson base their arguments on their claim that “serious adverse events” are very common with mifepristone—occurring, they say, in slightly more than a tenth of patients.
They based this conclusion on information gleaned from an insurance claim database. It contained “de-identified data for all U.S. patients during the years 2017 to 2023,” and they identified 865,727 likely mifepristone-enabled abortions in this database. Of these cases, 10.93 percent ended in a “serious adverse event,” they say.
Clinical trial reports of a “less than 0.5 percent” adverse event rate are way off, they conclude—and therefore, they argue, mifepristone is neither safe nor effective.
But the methods they used to reach these conclusions are highly questionable.
First, they identified “mifepristone abortions” by flagging insurance codes indicating the prescription of mifepristone with or without misoprostol, a “medically induced abortion by oral ingestion of medication,” or the “elective termination of pregnancy” in conjunction with billing codes that suggest mifepristone was given.
Already there are problems. This study is supposed to concern the safety of people undergoing a drug-induced abortion, right? But people who have miscarried naturally are also prescribed mifepristone, and they seem to be lumped in here, despite the fact that they have different circumstances that could wind up producing more, fewer, or different sorts of adverse events than seen in patients prescribed the drug for elective abortion in the first 10 weeks. Furthermore, the authors do not seem to take into account whether patients followed up the mifepristone with misoprostol, as is the FDA’s recommended practice. Taking mifepristone alone might lead to different outcomes than seen with the two-pill protocol.
And then there’s a much bigger issue—what the study considers a “serious adverse event.”
There’s a clear pattern in the study, in which the very specific or clearly dire categories of adverse events occurred in a relatively small number of patients, while the categories that make up the bulk of adverse events flagged are vaguely defined and may represent minor or even benign situations.
Just 0.10 percent of cases resulted in patients getting sepsis, 0.15 percent ended in patients needing blood transfusions, and 0.22 percent in what the study authors define as other life-threatening events.
The rates of serious and well-defined complications here are all low and well within the parameters advertised by abortion pill manufacturers. The reason this study finds so much higher prevalence of adverse events comes down to the event categories they won’t tell us much about.
Emergency Room Visits and ‘Other’ Complications
Of the 865,727 cases analyzed (some of which involved repeat patients), 94,605 were determined by the authors to have ended in serious adverse events, which they defined as any one of a broad range of outcomes happening within 45 days of taking the pill.
Patients could be coded into multiple categories, so someone admitted to the hospital for an infection might be listed in both the infection and hospitalization categories.
The largest category of adverse events is “other abortion-specific complications,” reportedly experienced in 49,169 cases. But the authors give us little idea about what these “other” complications might be. By definition, they do not include sepsis, infection, transfusion, hemorrhage, an ectopic pregnancy, a need for a surgical abortion, or “other life-threatening events.” The only explanation the authors give is that “other abortion complications include codes specifically related to an abortion or miscarriage, as w
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