Who ya gonna believe: the FDA or hack judges?

The right's enthusiastic answer to the headline's question is: Hack judges!

I've insisted for many years that Republicans can't govern. And they can't. Look at all the roiling dysfunction wherever Republicans have power. That increasingly includes the courts.

The contagion, which has been spreading to the judiciary, commonly presents as an inability to discern what's real. I have long argued that reality discernment is the preeminent problem of our time, because it affects everything.

Thus we have a district court judge from Amarillo siding with plaintiffs in concluding that the FDA is wrong when it says the abortion drug mifepristone is safe. The drug, which has been administered to millions, has been in use in the U.S. for 23 years (even longer in Europe), and has been carefully scrutinized by the FDA all that time. Indeed, "The F.D.A. applies a special regulatory framework to mifepristone, meaning that it has been regulated much more strictly and studied more intensively than most other drugs."

Now comes a three-judge panel from the "conservative" Fifth Circuit Court of Appeals that seems at least somewhat agreeable to the Amarillo judge's ruling. In a hasty preliminary ruling, the appeals court harmfully reversed six-years-old FDA rule making, pending a full hearing on the matter.

You might think that even if the appeals court insisted on hearing such a seemingly flawed case, that it would at least give the tentative benefit of the doubt to the FDA and maintain the status quo pending its deliberations. The FDA, after all, has both the relevant experts and the legal mandate to oversee the drug, and has been exercising that expertise and mandate these past couple of decades. Alas, no. The appeals court jumped right in and messed things up.

Not disrupting the status quo pending a full resolution makes obvious good sense, but that's not how conservative courts roll these days. Thus, for example, a seemingly oblivious or uninterested Supreme Court allowed a 2021 Texas abortion law to stand, despite its being patently unconstitutional under half a century of Supreme Court precedent. The justices may have figured they were going to overturn that precedent anyway, or maybe they didn't want to address the noxious novelty (involving, basically, bounty hunters) of the Texas law, so why bother? Such not bothering permitted the Texas law, in all its magnificent illegality, to stand undisturbed by the justices for nearly ten months. So much for the rule of law.

Increasingly we see a right wing judiciary that reeks of ideological and even religious bias, which is why the Fifth Circuit's disruption of the status quo was done so effortlessly. Indeed, the Fifth Circuit adopted some of the Amarillo judge's activist language, which is a stunning breach of judicial propriety—certainly for the district judge, but especially for an appeals court. For example, a court that wanted to convey measured neutrality would not use terms such as "chemical abortion" that are employed exclusively by anti-abortion activists. Thus has the court telegraphed where it wants to go, and the law need not be an insoluble impediment to getting there.

So much is wrong with this case, yet it persists because a right-wing judiciary wants it to persist. The plaintiffs, who argue that mifepristone is unsafe, ought not even have been granted standing to bring the suit. Their flimsy argument for standing is that at some point one of them will inevitably, against his conscience, be called upon to clean up the mess caused by some other provider's prescribing the drug, and by golly, then what? Thus with a straight face do the plaintiffs insist that they themselves are being harmed, and the courts so far have been happy to go along with the charade. A court with some modicum of integrity would throw the plaintiffs out on the sidewalk. (There is relevant Supreme Court precedent regarding standing that we don't have time to get into here. And anyway, as we've seen, Supreme Court precedent ain't what it used to be.)

As an aside, doesn't one sense here at least a whiff of the right's inclination to somehow be personally harmed by—which necessitates control of—what other people do? The right's appetite for social control includes who can marry whom, what children are taught in school, what books are permissible in libraries, what women can do with their bodies, how children with gender dysphoria can be treated, and so on. Never mind that civil libertarians, teachers, librarians, medical providers, and parents are all horrified by such controlling encroachment.

But now I've strayed too far from my basic premise, which is that the right doesn't know what's real. In the case at hand, the core contention brought by the plaintiffs is that the FDA is simply wrong when it says that mifepristone is safe, which compels the question of who you're going to believe: the experts or religion-motivated activists? It's a parable for our time.

What's so mind-blowingly bonkers about all this is that none of it is hypothetical. We have decades of experience with the drug, and millions of doses have been administered. More than half of all abortions in the U.S. are now medication abortions, which overwhelmingly employ a protocol that includes mifepristone. If mifepristone is genuinely unsafe, we'd surely know it.

Thus does basic critical thinking tend toward an easy answer to the "who ya gonna believe?" question, even in persons who don't have time or inclination to master all the relevant details. I would argue that who you believe, in this and similar examples, says something important about how you think, and about how you discern reality. I would also observe that the right's consistent tendency toward conspiracy theorizing (such as by disbelieving the FDA) is in play here. These are broken brains.

One of the reasons the plaintiffs say the FDA is wrong is that the drug causes cramping and bleeding when it, in effect, induces a miscarriage. The plaintiffs view those symptoms as evidence of harm, whereas the FDA understands them to be a consequence of the drug working normally. The FDA insists that serious side effects are rare and, again, there have been millions of cases that presumably back up that claim. There's nothing wrong with curiosity, but any eagerness on your part to just accept the plaintiff's contention at face value is evidence that your mind isn't functioning properly, and that you, too, have motives beyond the discernment of reality.

Extending their bizarre reasoning, the plaintiffs claim that the FDA's approval of the drug was flawed from the outset, all those many years ago. This is an odd argument not just because it is false, but because the initial trials and assessments are performed in order to anticipate what harms might happen if the drug is approved, whereas now we have more than two decades of data about what does happen. Going back to the pre-authorization process and trials to gauge safety doesn't make much sense.

Such disordered thinking is similar to another recent and important public health matter. Florida's Governor Ron DeSantis has bizarrely claimed that Covid vaccines are harmful, and he even convened a "Public Health Integrity Committee" to investigate imagined wrongdoings by drug companies and public health agencies. One of the panel's members, Joseph Fraiman, was the lead author of a paper criticizing initial determinations of mRNA vaccine safety. That paper, which was cited by the governor, is a "reanalysis" of the data from Moderna's and Pfizer's phase III clinical trials involving some tens of thousands of participants that were conducted pursuant to vaccine emergency use authorization. ("Tens of thousands" of trial participants actually isn't a lot for uncovering the rarest of adverse events, but it's the best we can realistically do in such trials.)

The strange thing is that Fraiman's critique of the trials was published long after the vaccines had been in extremely wide use, with literally hundreds of millions of doses having been administered. It was also published long after studies such as this one, in JAMA Network, that came out a year earlier, and involved millions of patients. Despite all that, Fraiman and DeSantis fixate on the Phase III trials rather than the enormous body of subsequent data. Sound familiar?

In other words, Fraiman was complaining that the vaccines might not be safe because those initial trials were flawed (they weren't), even as hundreds of millions of administered doses by the time of his complaint showed they were in fact quite safe. Why didn't he look at that?

I remind you that we are talking here about reality discernment, and I hope you can see why I contend that right wingers have difficulties with it. They seem overwhelmingly compelled to create their own alternative realities on almost every topic. (There can only be one reality, else the word has no meaning. You're not allowed to make your own; you have to discern the one that is.)

Which is all bad enough. But when right wingers don robes they become activist right wing judges and justices, and perverse and destructive outcomes occur. When the judiciary coddles such ludicrous cases, and even intervenes in support of the whacko plaintiffs, it is both an embarrassment and a travesty. We're increasingly moving toward an upended world where reality-challenged judges contravene expert opinion in order to impose their own administrative fiats and thus dictate public health and other kinds of policy.

Soon it will fall upon the Supreme Court to clean this up. The problem, though, is that it, too, is replete with right wingers in robes. Much could go wrong. We will have to wait and see.

Copyright (C) 2023 James Michael Brennan, All Rights Reserved

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