Hiltzik: Pseudoscience at the Supreme Court

technohoop


If the effort to ban medication abortion now before the Supreme Court demonstrates anything, it’s that the damage caused in our society by junk science can be disastrous indeed.

That’s the implication of the retraction of two scientific studies, announced Monday by the journal publisher Sage. The studies provided the purported rationale for a Texas federal judge’s ruling overturning the approval of the abortion drugs by the Food and Drug Administration.

It’s impossible to overstate the potential ramifications of the ruling issued April 7 by federal Judge Matthew Kacsmaryk of Amarillo, Texas, which invalidated FDA approvals of the drug mifepristone dating back to 2000.

Experts identified…unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data that…demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part.

— Retraction notice of research on mifepristone

Kacsmaryk’s ruling was the basis for an outstandingly loopy decision by the U.S. 5th Circuit Court of Appeals on Aug. 19, which narrowed his ruling somewhat but not entirely. The Supreme Court has scheduled oral arguments on the case for March 26.

The worst-case scenario is that the Supreme Court will follow Kacsmaryk in revoking the FDA’s approval. That would block access to what has become the most common abortion method in the U.S. Providers would have to shift to other medications that are not as effective as mifepristone.

The court could also narrow the reach of the FDA’s actions in 2000, when it declared mifepristone safe and effective, and in 2016 and 2021, when it allowed patients to order the drug online and receive it by mail or from pharmacies rather than at doctors’ offices.

The court could restore previous rules limiting the use of mifepristone to the first seven weeks of gestation instead of the current 10 weeks. It could require that it be administered only through a physician’s prescription and only directly by doctors.

The damage could go further. An expansive Supreme Court ruling could cripple the FDA’s authority to determine the safety and efficacy of drugs and subject its judgments to increasingly partisan challenges. It could bring an antique, long-disregarded 150-year-old antipornography law to legal prominence.

Let’s start at the beginning, with Kacsmaryk’s 2023 ruling. As I’ve reported in the past, Kacsmaryk’s jurisprudence has been a blot on the judicial system since he joined the court in 2019 as a Trump appointee. Kacsmaryk is the only federal judge in the Amarillo district of the federal court in the Northern District of Texas.

That has made his courthouse a favored venue for right-wing litigants. A former functionary of a conservative Christian legal group, he has been a dependable foe of efforts to protect LGBTQ+ legal rights and access to contraceptives.

His record made him the ideal judge for a coalition of antiabortion groups including the American Assn. of Pro-Life Obstetricians & Gynrecologists and the Christian Medical & Dental Associations waging an attack on medication abortion.

Kacsmaryk’s April 7 ruling bristled with antiabortion terminology such as the terms “unborn human” and “unborn child”; abortion providers were labeled “abortionists.” By contrast, a ruling protecting access to mifepristone issued the same day by federal Judge Thomas Owens Rice of Washington state, an Obama appointee, used neutral language, such as a reference to “institutions and providers who provide abortion care.”

Kacsmaryk accepted common talking points of the antiabortion movement as legal conclusions. He cited the Comstock Act, an antipornography law enacted in 1873, no fewer than 29 times. He accepted as read the antiabortion movement’s contention that it barred the shipment of mifepristone through the U.S. mail, even though federal courts had rejected that interpretation for more than 100 years.

He questioned the FDA’s judgment that the drug was safe and effective, despite overwhelming evidence to the contrary. The core of Kacsmaryk’s findings questioning the FDA’s approval of the drug came from two studies led by James Studnicki, director of data analytics at the Charlotte Lozier Institute, which says in the mission statement on its website that it “advises and leads the pro-life movement with groundbreaking scientific, statistical, and medical research.”

Among the institute’s principal aims is “to warn women about the dangers of chemical abortion and expose the harms of the FDA’s current abortion pill policy that simply ignores the known risks.”

Kacsmaryk cited the Studnicki papers to endorse the plaintiff organizations’ conclusions that adverse reactions to mifepristone could “overwhelm the medical system and place ‘enormous pressure and stress’” on doctors due to “significant complications requiring medical attention,” and that women taking the drug were reporting to emergency rooms at much greater rates than those who had undergone surgical abortions.

Sage’s retraction notice explodes those claims. The papers were published in 2021 and 2022 in Sage’s Health Services Research and Managerial Epidemiology journal. (A third Studnicki paper published in 2019 but not cited by Kacsmaryk was also retracted.)

Sage’s inquiry was triggered by Chris Adkins, a pharmaceutical sciences professor at South University School of Pharmacy in Savannah, Ga.

Among the flaws Adkins pointed to was that one study appeared to inflate claims about adverse reactions to the drug by failing to distinguish ER visits for routine complaints from those due to the drug. Nor did the Studnicki research factor in the increases in medication abortions starting in 2000 or the increase in Medicaid enrollments in the same period, which was a factor in the growth of medication abortions.

Sage said that in its pre-retraction review, “experts identified fundamental problems with the design … and methodology” of the questioned papers, as well as “unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data that … demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part.”

Sage also noted that the papers declared that the authors had no conflicts of interest in researching and writing the papers. In fact, all but one of the authors of the studies Kacsmaryk cited were affiliated with the Charlotte Lozier Institute, the American Assn. of Pro-Life Obstetricians and Gynecologists, or the Elliot Institute, which are antiabortion advocacy organizations. Although the authors had disclosed their affiliations, Sage reported, they had not acknowledged that these posed a conflict.

Studnicki objects to the retractions, responding that the action is “unjustified” and that his data are “accurately reported.”

Kacsmaryk’s ruling has caused immense confusion in the administration of mifepristone. The 5th Circuit appeals court overturned his rejection of the FDA’s original 2000 conclusion that mifepristone is safe and effective, but upheld his overturning of the FDA’s loosening of restrictions on the use of the drug issued in 2016 and 2021. It stayed injunctions on those uses until the Supreme Court rules, however.

The appeals court opinion featured one of the more curious flights of fancy by a federal judge — a separate opinion by Appellate Justice James C. Ho, another Trump appointee. He advocated overturning the 2000 FDA approval as well as the 2016 and 2021 revisions, on the grounds that abortions cause “aesthetic injury” to doctors forced to participate in the procedure, even if only by treating patients for adverse reactions.

“Unborn babies are a source of profound joy for those who view them,” Ho wrote. “Doctors delight in working with their unborn patients — and experience an aesthetic injury when they are aborted.”

The real injury that could arise from the Supreme Court’s consideration of mifepristone would be to the use of science to validate judicial opinions by substituting junk science for rigorous research.

More than 20 years of medical practice has established that the drug is safe and effective for its purpose — indeed, safer than many other drugs in common use in the U.S. Revoking its approval would be based on no scientific evidence at all, only on politics. And that won’t be good for anyone.



Source link

Leave a Comment