A group of doctors is suing the Food and Drug Administration for what it claims are unlawful restrictions and advice on the use of ivermectin to treat COVID-19.
On Thursday, Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter filed a lawsuit against Xavier Becerra, secretary of Health and Human Services, and Robert M. Califf, the commissioner of food and drugs, at the FDA.
"I have kept over 3,900 patients out of the hospital," Bowden said on a conference call with reporters. "But it hasn't been easy. Sadly, fighting the system has been a much bigger challenge than fighting the disease.
"Despite my excellent track record treating COVID patients, the FDA's smear campaign against ivermectin continues to be a daily hurdle to overcome. The public needs to understand, what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship."
The suit, filed on behalf of Boyden Gray & Associates, argues that the FDA "cannot ban particular uses of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling — commonly referred to as 'off-label' use."
Ivermectin was developed in the 1970s as a veterinary medicine to treat parasitic diseases in livestock, but a decade or so later was hailed as a "wonder drug" and received approval for human use as a therapeutic against diseases such as river blindness — or onchocerciasis — and lymphatic filariasis.
Studies as early as October 2020 associated it with lower death rates in treating patients with COVID-19, but the FDA has been steadfast in pronouncements against using the drug for treatment of the novel coronavirus infections.
Some experts and government officials have questioned the FDA's intransigence on the issue of therapeutics for treatment of COVID-19, including ivermectin, questioning why the FDA has discouraged the use of cheaper, more widely available drugs in favor of the much-touted vaccines.
William Campbell and Satoshi Omura won the 2015 Nobel Prize in Physiology or Medicine for their research on the drug. Since 1987, it has been used safely in 3.7 billion doses worldwide.
The suit cites three examples the FDA used advising against ivermectin. One of which refers to an FDA tweet stating: "You are not a horse. You are not a cow. Seriously, y'all. Stop it."
According to Marik, that innocuous-seeming advisement is enough for medical practitioners to lose their license.
"Dr. Marik explains," the suit reads, "that it doesn't matter whether FDA statements are technically binding on health professionals. In his experience and observation, after the FDA's decision to interfere with the use of ivermectin to treat COVID-19, doctors have been threatened with revocation of their medical licenses and adverse disciplinary actions should they prescribe the drug contrary to the FDA's public position."
But while, as Bowden describes, "what the FDA has done" may be "illegal," it could soon be illegal to go against an FDA "advisement."
Coming on the heels of Bowden and her colleague's suit, lawmakers in California are poised to pass a "medical misinformation bill." AB-2098, which passed California's Assembly and is now being read in the state Senate, would designate any physician or surgeon who engages in the "dissemination or promotion of misinformation or disinformation" regarding COVID-19 is at "risk [of] losing their medical license."
One California physician, Dr. Syed Haider, said, "This begs the question of who decides what is the truth."
Haider, who has been reported to four state medical boards by pharmacists who he says "don't like filling ivermectin prescriptions," explains that the bill would prevent doctors from promoting off-label COVID-19 treatments.
"To say there are any risks associated with the vaccines is claimed to be misinformation or disinformation, and the working definition of misinformation or disinformation seems to be anything that would prevent someone from submitting to or doubting the FDA and CDC [Centers for Disease Control and Prevention] guidelines and recommendations," he added.
If AB-2098 becomes law, any doctor who prescribes ivermectin — even at the request of a patient — stands to lose their medical license in California and, for that matter, anywhere else in the country.
"Once you make this inroad in violation of physician autonomy on how to treat COVID for their patients, that could just be the beginning," Haider cautioned. "What about after that? Do you go after a doctor's ability to prescribe off-label for anything? Do we have to be restricted to what has been FDA approved for any indication? What happens when we don't have an on-label drug for the treatment of an indication? What then? How do we treat our patients then?"
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