Three prominent physicians have filed a lawsuit against the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) over allegations that those federal agencies effectively banned the use of ivermectin to treat Covid-19. Also named in the lawsuit were HHS head Xavier Becerra and FDA chief Dr. Robert Califf.
The three physicians — Dr. Robert L. Apter, M.D.; Dr. Mary Talley Bowden, M.D.; and Dr. Paul E. Marik — claim that the federal government overstepped its bounds when it directed physicians and the general public “not to use ivermectin to treat COVID-19, even though the drug remains fully approved for human use.”
Recall that during the height of Covid-19 hysteria, ivermectin was widely ridiculed by many in the mainstream media as a “horse dewormer,” even though it had a Nobel Prize-winning pedigree for its uses in treating malaria and had been approved for use in humans by none other than the FDA.
According to FDA attorney Isaac Belfer, the federal agency did disparage the drug but did not, technically, ban its use.
“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do,” Belfer said.
“They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Belfer has said.
“They use informal language, that is true. It’s conversational but not mandatory,” Belfer said.
Among that “informal language” were several social media posts that strongly hinted that taking ivermectin, whether provided by a physician or not, was a fool’s errand, akin to using veterinary medicine.
One tweet from August 21, 2021 stated, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The tweet linked to an article from the FDA titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
Another tweet dated April 26, 2022 read, “Hold your horses y’all. Ivermectin may be trending but it still isn’t authorized or approved to treat COVID-19.” This tweet linked to the same FDA article about why one should not use ivermectin to treat Covid-19.
An attorney for the physicians, Jared Kelson, says that the FDA went way too far in criticizing a medication that had been proven effective in certain antiviral applications.
“Conversational” or not, Kelson argued, the FDA’s words “clearly convey that [ivermectin] is not an acceptable way to treat these patients.”
The attorney for the physicians noted that if the government “is going to label ivermectin a horse medicine or a horse de-wormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out.”
The FDA and HHS are very strong supporters of the experimental Covid vaccines, and have disparaged other treatment options, including ivermectin and hydroxychloroquine.
Government lawyers have moved to dismiss the case, claiming that the physicians’ complaints can’t be reasonably linked back to the FDA.
“It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA,” Kelson said.
One of the physicians suing the government, Dr. Marik, chief of pulmonary and critical care medicine at Eastern Virginia Medical School and director of the intensive care unit at Sentara Norfolk General Hospital, was using ivermectin to treat Covid-19 patients in 2020. After the FDA’s “conversational” statements, the medical school demanded that he remove his ivermectin protocol from its website.
Also after the government’s bad-mouthing of ivermectin, Sentara cited the FDA in a memo directing hospital staff to stop using the drug for the treatment of Covid-19. Marik sued Sentara, claiming it was outrageous to block a treatment option without scientific evidence that the option was harmful or ineffective.
“This is really unprecedented in the world,” Marik said on a podcast with Dr. Mobeen Syed. “The doctor at the bedside decides what’s best for his or her patient. He takes responsibility for the patient. He understands the patient. He individualizes the patient.”
In the case of ivermectin, hospital and government functionaries “who have limited or no experience with COVID,” according to Marik, were guilty of telling physicians what to do regarding a known and frequently used antiviral drug. And in the process they attacked the drug itself as being a purely veterinary drug and painted physicians who might prescribe it as fools.
