#933: "A Toad Under the Harrow"
Matthew Kacsmaryk is a Judge of the United States District Court for the Northern District of Texas. He is the jurist (?) who, just the other day issued a ruling in case No. 23-10362, called ALLIANCE FOR HIPPOCRATIC MEDICINE et al v. U.S. FOOD AND DRUG ADMINISTRATION et al, by which he single-handedly fulfilled the hopes, prayers and genuflections of millions of “hyper-moral, liberty-loving Americans” by issuing a nationwide ban on the use of the abortifacient Mifepristone (Mifeprex, a progesterone blocker), one of two drugs (the other being Misoprostol, a hormone originally created to prevent stomach ulcers caused by anti-inflammatories [NSAIDs] which are commonly used to medically terminate pregnancies. (n.b. The Fifth Circuit Court of Appeals quickly reversed part of Kacsmaryk’s ruling, though the case will likely go before the Supreme Court for full resolution.)
Judge Kacsmaryk’s ruling, to say the least, was and is both bizarre and deeply troublesome. Unquestionably, the most bizarre aspect of his 49-page ruling (much of it a listing of the various plaintiffs and defendants) was his repeated reference to the 150-year old Comstock Act . The Act is an anti-vice law passed in 1873 that prohibits the mailing of “obscene or crime-inciting matter.” Kacsmaryk’s effort to resuscitate this 19th-century relic, indicates that an antiquated law passed during the Reconstruction era, will play a central role in the post-Roe v. Wade apocalyptic landscape of abortion law. #🟦
As described in a December 2022 memorandum by the Justice Department’s Office of Legal Counsel, the original Comstock Act arose from “the handiwork of Anthony Comstock—‘a prominent anti-vice crusader who believed that anything touching upon sex… was obscene.’”
Comstock—who helped found the New York Society for the Suppression of Vice—championed the initial version of the law which forbade the mailing of any drug, medicine or anything “for the prevention of conception, or for causing an unlawful abortion.” The prohibition on contraception and the word “unlawful” were eventually dropped. In its current form found at 18 U.S.C. 1461 (Mailing obscene or crime-inciting matter), the law prohibits “every obscene, lewd, lascivious, indecent, filthy or vile article, matter, thing, device or substance; and every article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use” as well as advertising anything falling within these broad categories.
The most deeply troublesome part of his ruling, of course, is its central assertion: that in giving the legal stamp of approval for the use of Mifepristone in 2000, the FDA got it wrong; that the agency - whom many of the ‘hyper moral’ claim is run and staffed by liberal doctors, scientists and elitists with a pro-abortion agenda - all but ignored the possible bad (or even lethal) side effects (called “adverse events” in medical research jargon) for purposes of getting it on to the market.
In the first 18 years of its legal existence, the FDA reported that 24 women, out of approximately 3.7 million (0.000064%), have died after taking mifepristone for the purpose of medical abortion. However, as the FDA notes, “The adverse events cannot with certainty be causally attributed to Mifepristone because of concurrent use of other drugs, other medical or surgical treatments, coexisting medical conditions, and information gaps about patient health status and clinical management of the patient.”
In other words, Judge Kacsmaryk’s contention vis-à-vis bad side effects is utter stuff and nonsense.
The FDA first approved Mifeprex (mifepristone) in September 2000 for the medical termination of pregnancy through seven weeks gestation and this was extended to ten weeks gestation in 2016. The FDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg, in April 2019. The agency’s approval of this generic reflects its determination that Mifepristone Tablets, 200 mg, are therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation.
By extension, Judge Kacsmaryk’s ruling could be used to call any FDA-approved drug or device into question. What’s to say that next week, some fundamentalist group of physicians, pharmacists or chemists wants to sue the FDA over the approval of contraceptive pills, hormones or medical devices because the pre-marketing research wasn’t as muscular as it should have been? Or that the major COVID vaccines and boosters cause far too many deaths? First they came for the press in order to get the public to distrust anything they said or printed. Next they came for the White House and the Congress until its ratings were in the sewer. Now, if Kacsmaryk and his “patriotic” cronies have their way, trust in the Food and Drug Administration (which, by the way, was never run by Dr. Fauci, as many of them claim) will also fall beneath the sub-basement.
(n.b. Yesterday (4/15/23) Supreme Court Justice Samuel Alito issued an administrative stay of Judge Kascmaryk’s ruling until the end of the day, Wednesday, April 19. The Department of Justice has filed paperwork with SCOTUS, arguing that Kascmaryk’s ruling is legally unsupportable, and thus should be overturned.)
Those of us who labor long and hard in the vineyards of research, clinical trials and medical ethics (which is not an oxymoron), know very well just how long, exhausting and thoroughgoing the process is for getting anything medical, pharmaceutical or technical approved by the FDA. Generally speaking, it takes years, billions of dollars, and innumerable trial phases (starting with laboratory animals, then healthy human subjects, then subjects having a particular disease or condition and finally, post-marketing statistics. Anyone participating in trials is fully informed as to what is going to happen if they voluntarily consent to enter a study. Any and all potential adverse events are spelled out; anything in a consent document that is even remotely pushy or fanciful is deleted. Every step along the way is evaluated and overseen by either a Board of Ethics or an Institutional Review Board. This is how I’ve been earning my living for several decades . . . (And by the way, all consent documents contain a boilerplate comment to the effect that “there may be other potential adverse events that we are not currently aware of.”)
Debunking Judge Kacsmaryk’s contention that not all dangerous side effects were investigated prior to FDA approval of Mifepristone or Misoprostol is actually pretty easy: all one has to do is go to www.clinicaltrials.gov type in which ever drug, device or surgical technique you wish, and you will get a full history of any and every trial ever done. As but one example, if you go to the site and type in Mifepristone, up will pop 227 different trials and studies carried out over the years. You will discover that there are still active studies investigating other uses for this drug . . . including certain types of breast cancer, type2 diabetes and Adenomyosis. Type in Misoprostol and you will find 566 past, present and proposed studies on many, many issues affecting women.
(Please note: deciphering medical terminology can be difficult. If you go on to the clinical trials website, you may need to ask your family doctor, specialist, pharmacist or, in some cases, your rabbi (!) to translate things into understandable English.)
Judge Matthew Kacsmaryk (1977- )
At about the time Matthew Kacsmaryk was being considered for a lifetime appointment to the federal bench (early 2017) he submitted a draft article to a Texas law review criticizing Obama-era protections for transgender people and those seeking abortions. At the time, he had already spent several years working for a conservative legal group fighting legal fights on behalf those who demanded that their religious beliefs and scruples be protected as a matter of law.
The Obama administration, the draft article argued, had discounted religious physicians who “cannot use their scalpels to make female what God created male” and “cannot use their pens to prescribe or dispense abortifacient drugs designed to kill unborn children.”
But a few months after the piece arrived, an editor at the law journal who had been working with Kacsmaryk received an unusual email: Citing “reasons I may discuss at a later date,” Kacsmaryk, who had originally been listed as the article’s sole author, said he would be removing his name and replacing it with those of two colleagues at his legal group, First Liberty Institute, according to emails and early drafts obtained by The Washington Post. The article, titled “The Jurisprudence of the Body,” argues that religious physicians “cannot use their scalpels to make female what God created male” and “cannot use their pens to prescribe” abortion medication “designed to kill unborn children.” Kacsmaryk asked for his name to be removed from the article for “reasons I may discuss at a later date” and be replaced by two coworkers at the religious freedom-focused law firm
When Matthew Kacsmaryk appeared before the Senate Judiciary Committee, his dossier and collection of legal essays did not contain any information about “The Jurisprudence of the Body." It had simply disappeared from his record. In swearing to tell the truth, the whole truth and nothing but the truth, he told the assembled senators that his private religious beliefs would in no way affect his ability to make dispassionate decisions based solely on the law and legal precedents. In other words, like the 3 justices named to the Supreme Court by Donald Trump (Neil Gorsuch, Brett Kavanaugh and Amy Coney Barrett), Matthew Kacsmaryk lied; they too proclaimed that they would follow legal precedent when it came to Roe v. Wade. And of course, all 3 voted in favor of its dismemberment.
I wonder how Judge Kacsmaryk or the current Supreme Court would respond to a lawsuit filed on behalf of plaintiff’s claiming that the drug Sildenafil should never have been approved by the FDA? Using the Texas judge’s legal logic, it should be banned. This, of course, will never happen; it will never even be considered. Why? Because Sildenafil is known by 2 generic names: Viagra and Revatio.
The next time we vote, please remember that positions on the federal bench are lifetime appointments. It is far too easy for ideologues like Kacsmaryk or G-d knows how many Trump/McConnell/Federalist Society appointees who urrent occupy seats and gavels which will give them the power to veto the wishes of vast majorities for at least the next generation, if not 2. This should become a major, major issue for the 2024 elections.
As to Judge Kacsmaryk himself, he should be feeling, in the words of the great British novelist and wit P.G. Wodehouse, like “a toad under the harrow” . . . like one soon to be chopped up into little pieces. Although Wodehouse was writing about Hildebrand Spencer Poynt de Burgh, twelfth Earl of Dreever, it could easily have been about Matthew Joseph Kacsmaryk. Writing about the good Earl of Dreever, Wodehouse noted: “Nature had equipped Hildebrand Spencer Poynt de Burgh with one of those cheap-substitute minds. What passed for brain in him was to genuine gray matter as just-as-good imitation coffee is to real Mocha. In moments of emotion and mental stress, consequently, his reasoning . . . was apt to be in a class of its own.”
Copyright©2023 Kurt F. Stone