Opinion | SCOTUS’s mifepristone decision and retracted studies

This is a big deal. Removing a published article from a scientific journal doesn’t happen because of some small error. It’s unusual for a paper to be retracted (about 1 in 500), but the rate is increasing — and misconduct accounts for the majority of such instances. A retraction can be decided by the authors (after realizing a huge error) or by the publisher (over fraud, plagiarism, ethics, etc.).

The legal challenge was set off by a group of antiabortion doctors who argued that the Food and Drug Administration ignored safety concerns when it eased restrictions on mifepristone’s availability. They relied on scientific studies claiming the medication is dangerous, citing the number of emergency room visits after mifepristone use. After publication, though, other scientists voiced major concerns about the statistical methods and thus questioned the conclusions.

For example, an external group found that one of the retracted studies used inaccurate medical codes — numbers used to translate health-care procedures and diagnoses — to count “abortion-related” emergency room visits. The study used codes for ectopic pregnancies, which occur naturally and are unrelated to abortions..

The findings were presented in other deceiving ways, too, such as charts and graphs containing dual y-axes (two scales in the same chart). This is a screenshot of the chart originally published:

However, when the y-axis properly shows a single scale, one can see that abortions lead to a very small number of emergency room visits. This is how the chart looks in the correct scale:

After these concerns were raised, Sage asked two subject matter experts and one independent statistical analysis specialist to peer-review the studies (which had been published in 2019, 2021 and 2022). Sage did not publish the experts’ peer review, which is normal practice. However, given the stakes of this case, it could be coming.

The experts identified major ethical issues and scientific errors, including: A peer reviewer knew at least one of the authors of all three studies, and several are members of the same pro-life advocacy organizations, despite declaring no conflicts of interest in the study. The Sage review also concluded there were “unjustified or incorrect factual assumptions,” “material errors” and “misleading presentations” of data that “demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part.”

Clinical guidance and policy are (ideally) built on decades of research and consideration of the totality of evidence. In the case of mifepristone, more than 100 studies show it’s safe — in fact, safer than Tylenol — with only a few discordant studies. However, big mistakes can make it past the peer-review process, and, in some rare cases, “mistakes” are intentional and egregious. Even if studies are retracted, they can do a lot of harm. (Just look at the Wakefield study on autism and the measles, mumps, and rubella vaccine.)

A lot of emotion and opinions surround abortion. But I hope we can all agree that we deserve a solid foundation of data to make smart policy decisions. This bedrock is highly dependent on ethical scientists and a strong review process. Retracted studies should never have…