Science, Not Ideology

 When I worked for the Emmes Corporation, one of my duties was to present orientation lectures to new employees. The lectures involved such things as research ethics and the history of the regulation of pharmaceutical products. I discussed how the regulation of drugs began and how the Food and Drug Administration came to be. We went from a Wild West concept where caveat emptor was the rule to a regulated industry where experts employed by the FDA (along with advisory boards of outside experts) reviewed data to ensure that efficacy and safety were present in anything that was allowed to reach the market. That prevailed until yesterday, 7 April 2023, when a federal judge with zero expertise in medicine and pharmacology issued an ideologically driven decision to remove a drug from the market which was approved 23 years ago.

The federal district judge who made the ruling that the FDA should remove its approval of mifepristone, Matthew J. Kacsmaryk, is a long-time foe of abortion. As the only federal judge in the Northern District of Texas, the Alliance for Hippocratic Medicine (composed of conservative religious medical groups) knew that Kacsmaryk would be the only judge to rule on their suit if it was brought in Amarillo. This is a classic case of judge-shopping for legislating from the bench, a practice conservatives professed horror at for years.

What they did not anticipate would be a ruling from another federal judge within an hour of Kacsmaryk. Judge Thomas O. Rice, based in Spokane (I don’t know but I am guessing he is the only federal judge there) ruled exactly the opposite, ordering the FDA not to restrict mifepristone in the 17 states and the District of Columbia that sued to maintain keeping mifepristone available for their population. The likely result will be a swift trip to the Supreme Court – but swift could still take months or even years.

I firmly believe that medically safe abortion must be available to women. This is part of women’s healthcare. Mifepristone is safe, despite the crazy slanted case brought to Kacsmaryk by the Alliance for Hippocratic Medicine. It was safe 23 years ago when it was approved by the FDA. It is safe now with even more studies that show safety. Here are the studies that Kacsmaryk supposedly reviewed (remember, he is a lawyer and a judge, not a physician):

In other words, the FDA defense included 37 studies and the Alliance for Hippocratic Medicine included 5 (image from New York Times). The preponderance of the evidence is solid that mifepristone for abortion is both efficacious and safe.

There is a fine, short article in The New England Journal of Medicine that succinctly shows why this lawsuit is based on faulty legal reasoning but also shows how upholding the ruling from Kacsmaryk will open Pandora’s box to other mischief. Other drugs and vaccines could face challenges based on ideology rather than science and data, thus endangering public health. Stop the nonsense.