Back in 2021 and 2022, and to this day, appropriate medical treatment for COVID-19 has been a contentious subject. For many, even the existence of SARS-CoV-2 disease has been an open question. But for many others, the question has been how best to treat this condition. Early on, many doctors reported successfully using ivermectin. And also early on, the Food and Drug Administration waged an information campaign against this anti-parasite medicine which has been used by millions in the third world, with great safety and efficacy. The developers of ivermectin received Nobel prizes for their work.

And while the use of this drug is still hotly contested, a new legal settlement on March 21, 2024 between FDA and three physicians suing the agency is a win for patients and doctors who are entitled to the freedom to use their best judgement is deciding how to approach treatment for COVID-19.

FDA to take down “You are not a horse” post

According to plaintiffs’ attorneys at Boyden Gray PLLC, FDA has agreed to take down its “most viral social media campaign of all time” which included an infamous “You are not a horse” tweet and related posts. In Apter v. Dep’t of Health and Human Services the plaintiff doctors filed suit alleging that FDA was unlawfully providing medical advice relating to off-label usage of ivermectin for prevention or treatment of COVID-19. “Today’s settlement with the FDA is a major win for the doctor-patient relationship,” noted Paul E. Marik, M.D., FCCM, FCCP, who is one of the physicians in the case. “It vindicates our position that the FDA overstepped its regulatory authority by trying to dictate appropriate medical care.”

Fifth Circuit ruled FDA crossed the line

In a September 1, 2023 Fifth Circuit appellate decision, the court had held that FDA “has identified no authority allowing it to recommend consumers ‘stop’ taking medicine” or to give any medical advice, even in “tweet-sized doses.” The court also emphasized that the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.” According to Boyden Gray’s attorney Jared Kelson, “This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA–It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.” The ruling allowed that while FDA can “inform,” it has no authority to tell anyone to “stop” taking a medicine prescribed by their doctor. This Fifth Circuit ruling reversed a decision to dismiss the case and sent it back to the trial court for litigation, leading to the settlement.

Settlement details: 21 days to remove posts

Per the March 2024 settlement, plaintiff doctors Robert L. Apter, Mary Talley Bowden, and Paul E. Marik agreed to drop their lawsuit on condition that the anti-ivermectin materials be removed by FDA. Under the deal, DHHS and FDA have 21 days to “Retire” the famous “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” post from March 2021. FDA must also “delete and not republish” its Twitter, LinkedIn, and Facebook posts from August 21, 2021, that said, “You are not a horse. You are not a cow. Seriously, y’all. Stop it” and its Instagram post from that same date stating “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID”. The agency also must take down other similar postings from other social media. As is common in some settlement agreements, this order includes that, “Neither this Stipulation of Dismissal nor the actions described herein shall constitute an admission or evidence of any issue of fact or law, wrongdoing, misconduct, or liability on the part of any party to this litigation.”  

 The practice of medicine

The 10th Amendment of the US Constitution authorizes states to establish laws protecting the health, safety, and general welfare of citizens. Generally speaking, it is solely a state-level issue to define the practice of medicine, and definitions tend to be very broad, to include any action to treat a disease or condition. Under California Business and Professions Code 2052, for example, it is a felony for “any person who practices or attempts to practice, or who advertises or holds himself or herself out as practicing, any system or mode of treating the sick or afflicted in this state, or who diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition of any person” to do so without a medical license.

A win for patients beyond ivermectin

Notably, while ivermectin has detractors, from mainstream doctors who think the evidence is too weak to support use of this drug to those with a broad distrust of our pharmaceutical industry, this settlement agreement is a win for doctors and patients in protecting their right to decide what and how to use medicines. Looking beyond ivermectin, the Fifth Circuit ruling and the later settlement should accrue to the benefit of all Americans who seek medical and health freedom. And the argument that FDA was essentially practicing medicine without authority could have wide-ranging impact, e.g. many practices, such as water fluoridation or face-masking mandates, might be susceptible to similar challenges.

 Much at stake: vaccines and more

The campaign against ivermectin was much broader than just FDA action; and without taking any views on the utility of this drug, it can be noted that there was much at stake: if ivermectin had been approved for COVID-19, there would have been no legal basis for mRNA vaccine Emergency Use Authorizations, or likely Paxlovid development.  

And we need to see FDA’s ivermectin over-reach as only one example of the widespread use of official and semi-official means to create broad control over information flow, so as to suppress a doctor’s ability to use the best available methods to treat and prevent illness. In so doing, government officials and their agencies have also suppressed the patient’s access to the kind of health care they seek, with the doctors that they wish to use.