Three years after launching a crusade against ivermectin as a treatment for Covid-19 — and nearly two years after doctors sued to stop it — the Food and Drug Administration (FDA) agreed to remove online content disparaging the drug as intended only for livestock.
On Thursday, the FDA reached a settlement in a lawsuit brought in June 2022 by physicians Mary Talley Bowden, Paul Marik, and Robert Apter alleging that the agency had overstepped its authority by advising patients not to use a particular treatment.
According to Newsweek, within three weeks of the settlement,
the FDA will retire a Consumer update titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
The FDA also will delete and not republish posts to Twitter (now X), LinkedIn and Facebook that read: “You are not a horse. Your [sic] are not a cow. Seriously, y’all. Stop it.”
Also, it will delete and not republish an Instagram post reading: “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID,” as well as a Twitter post that reads, “Hold your horses, y’all. Ivermectin may be trending, but it isn’t authorized or approved to treat COVID-19.”
The FDA had previously deleted from its website a “Frequently Asked Questions” page on ivermectin that the doctors had also challenged.
“FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history,” Bowden posted on X. “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”
Apter told The Defender that the settlement was “wonderful news and one more step towards putting the government back in its place from its COVID-era overreach.”
Marik, likewise, told the website that the agreement was “one of the most important wins in the whole COVID era.”
“It goes beyond ivermectin,” he said. “It goes to the authority of the FDA, what they can and they can’t do. It’s really about the patient-physician relationship, doctors being allowed to be doctors and prescribe medicine. And so hopefully going forward this will limit the interference by the regulatory agencies to control medicine.”
The FDA appears not to have been chastened by the experience, however. In a statement to Newsweek, the agency said it had “chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”
“FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates,” it added.
Furthermore, the agency reiterated its belief that ivermectin has not been shown to be “effective against COVID-19” and is “not authorized or approved” for use in treating the disease.
Clearly, not everyone agrees with the FDA’s assessment. The Defender pointed out that there are “numerous studies — including studies posted on [the FDA’s] own website — showing ivermectin could be effective as an early intervention against COVID-19” and that the drug was “administered widely in several countries.”
“The FDA demonized ivermectin, which is a highly effective drug for the early treatment of COVID. The consequences of this, and what has to be clear is that this led directly to the death of millions of people,” Marik told The Defender. “So the FDA has blood on its hands.”
Why would the FDA make war on a safe, effective treatment whose discovery resulted in a Nobel Prize? Some critics have placed the blame on the agency’s determination to grant emergency-use authorization for the Covid-19 vaccines, which required there to be no other effective treatments.
“The FDA knew exactly what it was doing when it tweeted that ivermectin was for horses and that people should ‘stop it,’” Dr. Pierre Kory, president of the Front Line COVID Critical Care Alliance, told The Defender. “I hope this case will serve as precedent the next time a federal health agency steps out of its authority and tries to practice medicine.”
It’s hardly the first time the FDA has sided with Big Pharma over patients.
“Ivermectin is not an exceptional case,” independent presidential candidate Robert F. Kennedy, Jr., posted on X. “The FDA is biased against many low-cost, generic, and/or natural therapies with low profit potential. Could it be because half its funding comes from Big Pharma?”
In their lawsuit, Bowden, Marik, and Apter alleged that the FDA “acted outside of its authority, which is limited to approving drugs and drug labeling,” reported The New American.
A U.S. district judge dismissed the case in 2022, claiming the FDA has “sovereign immunity” against most civil suits. The Fifth Circuit Court of Appeals, however, overturned that decision in September, declaring, “FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise.”
“Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority,” the court contended.
Perhaps the likelihood of losing an even more protracted legal battle led the FDA to settle the case. But, whatever the reason, the result is heartening.
“While this resolution is long in coming … it is one more building block in the edifice to stop future encroachments on the doctor-patient relationship, free expression, and the FDA’s unlawful practice of medicine,” said Apter.
