by Greg Piper
The Food and Drug Administration wants to continue its selective promotion of off-label drug use: good for COVID-19 vaccines, bad for alternatives to those vaccines. It just doesn’t want the public to see its full reasoning for the latter.
The FDA and the Department of Health and Human Services filed a renewed motion to dismiss a lawsuit by doctors claiming the agencies have a practice of demonizing ivermectin by conflating its human and animal doses and using “command” language, such as “stop it,” to discourage using the anti-parasite drug against COVID.
But it was filed under seal, with the agreement of U.S. District Judge Jeffrey Brown and plaintiffs Drs. Robert Apter, Mary Talley Bowden, and Paul Marik, who claim they suffered wide-ranging injury from the anti-ivermectin campaign.
The feds cited “lack of subject-matter jurisdiction” – the doctors lack legal standing – in a Dec. 2 request for an extension of time to submit the dismissal motion.
The agencies are starting over after the 5th U.S. Circuit Court of Appeals reinstated the lawsuit last year, finding the doctors plausibly alleged the FDA exceeded its authority through “tweet-sized doses of personalized medical advice.”
The three-judge panel tasked Brown with considering “standing and any other jurisdictional issues in the first instance.”
https://twitter.com/US_FDA/status/1429050070243192839?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1429050070243192839%7Ctwgr%5Ee57400ab470ed39b4efda5766378211748e6ea0a%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fjustthenews.com%2Fgovernment%2Ffederal-agencies%2Ffeds-hide-details-about-anti-ivermectin-campaign-response-doctors
“One of the plaintiffs in this case is a party to a separate, state-level confidential proceeding,” according to the feds’ motion to seal, filed Dec. 22, which Brown approved four days later.
The agencies’ 18 exhibits in the renewed motion to dismiss “include confidential information from that proceeding.”
The motion doesn’t explain why the feds cannot simply redact identifying information from relevant documents. But the doctors’ opposition last week to the dismissal motion appears to give away the target and conductor of the “confidential proceeding” – Apter and the Washington Medical Commission – and other details, undermining the basis for sealing.
The FDA told Just the News it “does not comment on possible, pending or ongoing litigation.” HHS and the doctors’ lawyers at the powerhouse D.C. firm Boyden Gray didn’t respond to emails.
The agency’s interest in cracking down on off-label uses – prescribing a drug for a different purpose than what the FDA approved – spiked in 2021 when doctors such as Apter, Bowden, and Marik started prescribing ivermectin to treat COVID.
Its social media posts portrayed the antiviral with a long human safety record as a barnyard medicine prohibited for human use, which Brown said “bother[ed] me the most” in a November 2022 hearing on the original motion to dismiss. The judge approved it anyway, finding the doctors couldn’t overcome the FDA’s sovereign immunity.
The FDA also gained what a drug industry reporter called “very unprecedented” authority from Congress last year to regulate off-label uses after it kept losing court battles about its existing authority to do so, though it’s not clear whether drugs are covered by the new statutory authority against “banned devices.”
Commissioner Robert Califf tacitly promoted an off-label use of COVID vaccines a day after the feds’ renewed motion to dismiss, however, using his official X account to tout an unpublished study that found vaccinated children “have a substantially lower rate of Long Covid,” in his words.
Good news about vaccinated children for Covid-19. Children who are vaccinated have a substantially lower rate of Long Covid compared with unvaccinated children. 🔗👇 https://t.co/j938eLsZ8L
— Dr. Robert M. Califf (@DrCaliff_FDA) December 23, 2023
The doctors blasted the FDA’s argument that its anti-ivermectin messaging, which extended to warning letters to state medical and pharmacy boards that “obviously want to stay in the good graces of a federal regulatory body,” had nothing to do with their alleged suffering.
Pharmacists have invoked the “FDA directives” to refuse to fill prescriptions for Bowden and Apter, harming their patients through delays because ivermectin is most effective in early COVID treatment, and insurance won’t cover it for the same reason, according to the doctors’ Jan. 12 opposition.
The Iowa Board of Medicine referred Apter to the Washington and Arizona medical boards for investigation, similarly citing “FDA publications” against ivermectin. And Houston Methodist Hospital “derided” Bowden and “forced [her] to resign her privileges for prescribing ivermectin,” the opposition says.
Marik was “forced to resign” from Sentara Norfolk General Hospital and Eastern Virginia Medical School despite developing the latter’s COVID treatment protocol.
Don’t let them ignore Covid! “If it’s not safe enough for them, if it’s not safe enough for their children, then it’s not safe enough for their constituents and it’s time for them to really speak up.” Full interview with @ShannonJoyRadio in comments. pic.twitter.com/em2Jw2QgNc
— Mary Talley Bowden MD (@MdBreathe) January 14, 2024
The doctors claim the Aug. 21, 2021, “Stop it” X post on ivermectin, which showed a horse, was the “most-viewed in FDA history,” though the only analytics visible to the public are comments (15,000), reposts (67,000), likes (106,000) and bookmarks (3,200). Its Instagram horse post “Stop it with the #Ivermectin” has nearly 21,000 likes.
“Common sense confirms that the only reason the FDA would issue its ivermectin publications in the first place is because of the predictable and intended effects they would have on healthcare professionals, regulatory boards, hospitals, patients, and the broader public” to halt ivermectin in COVID treatment, the doctors said.
The opposition refers 28 times to the sealed renewed motion to dismiss and its hidden exhibits as “R-MTD,” first challenging the FDA’s claim that its anti-ivermectin campaign was a response to “multiple reports” of patients requiring “medical attention, including for hospitalization, after self-medicating with ivermectin products intended for animals.”
The FDA released its first such message in March 2021, eight months before the first reported animal-dose misuses; it was “still using the ‘horse paste’ trope” eight months after what turned out to be “a mere four people” misusing animal doses; and the agency repeatedly refused to distinguish human from animal doses, the doctors said.
The agency’s sealed evidence in the R-MTD undermines its own “factual challenge to the circumstances of Dr. Apter’s disciplinary proceedings,” they claimed. A pharmacist invoked FDA “recommendations” when reporting Apter to the Washington board for “[i]nappropriate prescribing,” saying he wouldn’t give a “valid [non-COVID] medical reason” for ivermectin.
More corroboration of sudden unexpected deaths due to the Covid Poison jabs
— Robert Apter, MD, FACEP (@RobertApter1) January 5, 2024
The FDA is wrong on case law when it claims “being subject to disciplinary proceedings is not a cognizable harm,” the opposition says. The doctors cite a precedent from the 6th Circuit, which doesn’t control Brown’s court, that found a state order to “stop or face disciplinary action” qualifies as “concrete and imminent harm.”
The R-MTD also ignores the well recognized injury of resignation “under duress” when it claims Bowden and Marik “voluntarily” left their positions, the doctors claim.
“The undeniable timing of these investigations and forced resignations immediately following when the FDA began its pressure campaign against ivermectin in earnest highlights the predominant role that issue played in the disciplinary actions,” the opposition says.
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Greg Piper has covered law and policy for nearly two decades, with a focus on tech companies, civil liberties and higher education.
Photo “Ivermectin Tablets” by Bundesministerium für Finanzen. CC BY 2.0.
