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'Merely quips'? Appeals court says FDA denunciations of ivermectin look like 'command,' not advice

Second rough hearing for feds in a week at the 5th U.S. Circuit Court of Appeals. Medical boards are still investigating docs for promoting ivermectin.

Published: August 12, 2023 7:08am

The Food and Drug Administration (FDA)  is claiming in federal court that it never told doctors not to prescribe ivermectin to treat COVID-19. Federal judges aren't buying it, and state medical boards that rely heavily on FDA guidance continue to investigate doctors for such prescriptions.

Echoing a federal district judge nine months ago, a three-judge panel of the 5th U.S. Circuit Court of Appeals pressed a Justice Department lawyer to reconcile the FDA's repeated public denunciations of ivermectin as an off-label COVID treatment with its insistence that the agency is not liable for resulting investigations of doctors who prescribe or promote it.

Three doctors are suing the FDA for exceeding its statutory limits by "deliberately" interfering in the doctor-patient relationship through what their lawyer Jared Kelson called a "yearslong campaign" against ivermectin at Tuesday's hearing.

The case came before the same 5th Circuit panel of Republican presidential appointees that, two days later, compared the Biden administration's "strong-arming" of social media companies to censor what it called  "misinformation" to a mafia movie.

What was mainstream medical conventional wisdom continues to fall apart around a range of COVID subjects including the wisdom of remaining "up to date" on COVID vaccinations through boosters, as the CDC recommends. 

Epidemiologist Harvey Risch, Professor Emeritus of Epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health, shared recent Cleveland Clinic research with the "Just the News, No Noise" program that found that the more doses people receive, the higher the risk they have of contracting COVID. 

Referring to the research, Risch said: "That's saying that these boosters are incrementally doing harm to the immune system in general," when most people can treat the infection with "the medications that worked in the first year of the pandemic like hydroxychloroquine and ivermectin."

The 5th Circuit panel seemed skeptical of Civil Division Appellate Attorney Ashley Honold's argument that the FDA's "informational statements" against ivermectin, including its conflation of human and animal dosages, were "merely quips" about reported problems after "self-medicating" rather than "prohibit[ing] anyone" from using ivermectin.

Judge Jennifer Walker Elrod cited the phrase "Stop it" in the agency's viral "You are not a horse" post on X, then known as Twitter. "If you were in English class, they would say that was a command. … That is different than 'we're providing helpful information,'" she told Honold.

More than a year later, the FDA doubled down and again invoked horses and reminded consumers ivermectin "still isn't authorized or approved to treat COVID-19."

The purported quips did not "change the substance of FDA statements," Honold responded. The agency page linked from both posts urges consumers against taking ivermectin for COVID and claims it's not effective against the virus, but also tells them to take ivermectin "exactly as prescribed" if their doctors prescribe it.

Elrod lost patience with Honold when the lawyer repeatedly refused to answer whether "Stop it" was a command. "In some contexts, those words could be construed as a command" but not this one in a "quippy tweet," Honold said, adding that the FDA also warns consumers about "dangerous uses" of opioids despite their approval for some uses.

Honold couldn't provide Elrod with specific evidence that the FDA conducted a review of ivermectin in the COVID context before making its comments. "I don't think there's anything in the record that specifically tracks FDA's process," Honold admitted.

Judge Edith Brown Clement asked for the FDA's authority to regulate off-label uses of authorized drugs, alluding to legal uncertainty over whether drugs are covered by a federal law that prohibits the FDA from interfering in prescriptions of "device[s]."

"These statements are not regulations. They have no legal consequences," Honold responded. "They don't prohibit doctors from prescribing ivermectin" as treatment for any condition, including COVID. 

Elrod again told her she was avoiding the question: "To say that they weren't doing that is not the answer." Honold said the FDA has "inherent authority to further its mission by communicating information to the public about safe uses of drugs," such as by warning consumers against the "Nyquil Chicken Challenge" on TikTok.

The Federation of State Medical Boards, whose members have launched several investigations against doctors for prescribing or promoting ivermectin for COVID, did not answer Just the News' queries on how much faith they put on the FDA's denunciations of ivermectin and whether they should continue the investigations given the FDA's recent representations in court.

The federation's Texas member filed a formal complaint this year against one of the plaintiffs, Dr. Mary Talley Bowden, for unprofessional conduct for allegedly prescribing "medication" to a patient she had not examined at a hospital where she didn't have admitting privileges. The patient had sued the hospital to let Bowden give him ivermectin. A Texas appellate court held in 2021 that the hospital was not required to let Bowden administer ivermectin. 

Houston Methodist earlier suspended Bowden for sharing "dangerous information" including qualified support for ivermectin, which is referenced in the Texas Medical Board's complaint. 

Last month four doctors sued the Washington Medical Commission for adopting a "position statement" on purported COVID misinformation, "with limited notice" and no "opportunity for public comment," that the commission is now using "as an enforceable rule" without following required procedures.

Three of those doctors, two of whom live in Washington and one in Idaho, are under investigation for charges including prescribing and promoting ivermectin for COVID, according to MedPage Today. The fourth, who lives in Idaho, gave up her Washington license "under duress" this year for fear of investigation due to "speaking out against certain COVID public policies," especially vaccinating healthy children, the lawsuit says.

"Straight from the horse's mouth," Bowden quipped about the FDA's legal representations, asking the agency to "issue a statement so my patients can get their prescriptions filled" at CVS and Walgreens pharmacies. 

She said two patients recently told her they spend $450 and $2,500 for individual and family prescriptions of ivermectin, which she called a result of mainstream pharmacies and insurers refusing to fill and reimburse prescriptions.

"Doctors who had the courage and compassion to treat COVID patients believe hundreds of thousands of Americans died needlessly" because the FDA "sabotaged the use of cheap, safe, and effective generic drugs," Sen. Ron Johnson (R-Wis.) said, questioning the FDA's sudden redefinition of what constitutes "merely quips" as opposed to a federal agency's directive.

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