Friday, April 14, 2023

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

The latest from Does It Hurt To Think? is here.

Saturday, April 08, 2023

Vocabulary lesson and a judicial injunction

Today, boys and girls, we learn a new word: dysphemism.

Dysphemism is basically the opposite of euphemism. Euphemism, you recall, is the substitution of a "mild, indirect, or vague term for one that is considered harsh, blunt, or offensive." For example, relieving oneself is a euphemistic expression for urinating. One often uses euphemisms to mask or tone down unflattering or objectionable positions one holds.

By contrast, dysphemism is "the substitution of a harsh, disparaging, or unpleasant expression for a more neutral one." For example, taking a piss is a dysphemistic expression for urinating.

Euphemistic and dysphemistic expressions can both indicate bias—perhaps more so with dysphemisms, because they deliberately substitute loaded expressions for more neutral ones, and can therefore evince an intent to inflame. Thus we have Donald Trump referring to the "Chinese virus," at a time when expressions such as "novel coronavirus" or even just "coronavirus," and (the more technical) "SARS-CoV-2," were used by experts and public health authorities for the virus itself, and "Covid-19" for the disease caused by the virus. By using the dysphemistic "Chinese virus," Trump intended to cast (and divert) blame, and to denigrate one party (China), at a time when he was ostensibly communicating information to citizens about the state of the pandemic, and the government's response.

In that manner did Trump, as is his wont, inject some measure both of gratuitous conflict and buck-passing into what arguably should have been a more neutral and dignified account by the president of where the country stood relative to the pandemic. One might well expect that a high official in government communicating on a serious matter would confine himself to descriptive terminology that's been adopted by the appropriate experts, and that's in widespread use by other relevant organs and institutions such as the press. Not using such terminology communicates dysphemistic intent: a ratcheting up of tension and aspersion.

Trump's followers were unsurprisingly quick to pick up Trump's usage and run with it. Thus did I receive an email from one right-winger referring to the "Communist Chinese Wuhan coronavirus." And thus, too, were persons of Asian descent accosted with widespread taunts and even violent attacks on America's streets. That's how these things go, and it shows how and why words matter.

Very timely examples of dysphemism are contained in a federal judge's just-released nationwide injunction on the distribution of the abortion medication mifepristone. In his ruling, U.S. District Judge Matthew J. Kacsmaryk refuses to use neutral and technically correct terms such as "fetus," referring instead to "unborn humans" in his ruling. He also makes one reference to "unborn children" and another to "aborted children." The judge excuses his usage by writing that "fetus" does not encompass other (earlier) gestational stages, but that's a dodge. The neutral and technically correct "embryo or fetus" would be a proper and economical use of language, would be more appropriate in a judicial opinion, and would cover all cases concerning the administration of the drug in question.

But terminating (my euphemism for killing?) a fetus or embryo seems less disturbing than terminating a human and certainly a child, whether born or not. It seems the judge is in part verbally elevating and then condemning the act of killing, not just the process by which the drug was approved 23 years ago. To state what should be obvious, that is not his proper role. Moreover, "unborn human" is not a scientifically neutral term, but rather one that immediately evokes intensely contested philosophical and especially religious connotations that are unhelpful in an opinion about whether the FDA acted appropriately in the approval process. All this in a context in which the judge's strong longstanding religious opposition to abortion has been widely reported. The judge seems bent on imposing his beliefs on everybody.

Likewise, the judge dysphemistically refers to "chemical abortion" rather than "medication abortion" or, as it's often referred to in the media, "medical abortion." While it is trivially true that medications are generally chemicals, the term "chemical abortion" is used overwhelmingly by the anti-abortion movement but seldom, if ever, outside it. Through his use of terminology, the judge transparently and inappropriately indicates what side he's on.

You can see this for yourself by performing the Google search "chemical abortion". Pay attention to who uses which terms. When I did so just now, I found a link to a Kaiser Family Foundation article entitled The Availability and Use of Medical Abortion. There's a link to Medical Abortion, Conditions and Treatments at UCSF Health (University of California San Franciso). At Cleveland Clinic we have Medical Abortion: What Is It, Types, Risks & Recovery. All mainstream medical resources employing widely used neutral terminology.

Then there's Fact Sheet: Risks and Complications of Chemical Abortion from the Charlotte Lozier Institute, an anti-abortion organization. Next is Chemical Abortion: A Review from the conservative Heritage Foundation. See the pattern?

The American Congress of Obstetricians and Gynecologists, a professional organization with 60,000 members, refers to "Medication," not "Chemical" abortion. So does the Association of American Medical Colleges. The National Institutes of Health refers to "Medical abortion," as does UCLA Health. And so forth.

When we search Google for "chemical" vs. "medical" abortion, we see Important Truths Women Are Not Told About Chemical Abortions from Options Now, a pro-life group. There's Chemical Abortion from Students for Life of America.

You might think the American College of Pediatricians' Chemical Abortions: With and Without Medical Supervision conveys professional legitimacy to the term, but you'd be wrong. The American College of Pediatricians is, according to Wikipedia, "a socially conservative advocacy group of pediatricians and other healthcare professionals" with just several hundred members. The Southern Poverty Law Center, an anti-hate organization, refers to it as "a fringe anti-LGBTQ hate group that masquerades as the premier U.S. association of pediatricians to push anti-LGBTQ junk science."

For his part, Judge Kacsmaryk footnotes A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, by James Studinicki, in Health Services Research and Managerial Epidemiology. Finally, we see the term "chemical abortion" in a real medical journal! But not so fast. Dr. Studinicki is a member of —you guessed it—the Charlotte Lozier Institute. I have not found any usage of  "chemical abortion" outside anti-abortion advocacy groups or individuals.

It's telling that Judge Kacsmaryk's ruling reeks throughout of references to the "chemical abortion" dysphemism used exclusively by anti-abortion activists. The conventional "medication abortion" and "medical abortion" are nowhere to be found, even though you'd think that a judicial opinion on FDA process would use conventional terminology. Indeed, critics of Judge Kacsmaryk's opinion say he seems to have adopted the plaintiff's opinions, conclusions, and, yes, terminology, in sweeping wholesale fashion.

I said above that dysphemisms can signal bias, and we clearly see how that is so in the judge's ruling. Judge Kacsmaryk is himself a longtime anti-abortion activist. His ruling, which by all rights ought to be overturned on appeal, might have slightly better prospects if it didn't telegraph the judge's personal biases so strongly. A more judicious use of language would have helped his case by better disguising that bias. On the other hand, given the current makeup of the Supreme Court, the thing, flawed as it is—especially on the merits (which we've not gotten to here)—may well stand. It will be fascinating to see how this develops.

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

The latest from Does It Hurt To Think? is here.