FDA's Smug Anti-Ivermectin Post Backfires, Agency Forced in Court to Again Acknowledge Drug Is OK to Prescribe
CLARIFICATION, Aug. 28, 2023: This article has been revised to more clearly describe the FDA’s consistent formal position on ivermectin and to emphasize that the topic at hand is not the agency’s official stance on the drug but instead its social media post and the court case surrounding it.
Editor’s Note: Our readers responded strongly to this story when it originally ran; we’re reposting it here in case you missed it.
After years of denigrating ivermectin as dangerous and as “horse medicine,” the U.S. Food and Drug Administration has been forced to backtrack on a smug tweet posted in 2021 and acknowledge, yet again, that ivermectin can be prescribed to humans. This thanks to three doctors who sued the agency in federal court, claiming the FDA had impeded their right as medical providers to prescribe the medicine to their patients.
The acknowledgement took place during an Aug. 8 proceeding in which lawyers for the doctors asked the Fifth Circuit Court of Appeals whether doctors have a right to prescribe ivermectin since the FDA approved the drug for use in humans way back in 1986.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during the oral arguments in the case, the Epoch Times reported.
Viewed in the context of the infamous tweet, this could seem like a retreat from the agency’s alleged antagonism toward the drug.
Readers may recall that once the pandemic was in full swing, some doctors began reporting anecdotal evidence that ivermectin seemed to help some patients avoid or ease the symptoms of the coronavirus. Later studies called into question ivermectin’s efficacy in treating COVID, with some finding little to no benefit. But ivermectin’s efficacy isn’t really the legal question in this case.
Almost immediately, a movement emerged destroying the reputation of the drug, persuading doctors to avoid prescribing it, and discouraging pharmacies from selling it even with a doctor’s prescription.
It was derided as “horse medicine” and, therefore, unfit for use in humans.
In reality, not only has ivermectin long been used in humans, but long before the pandemic began, its positive impact on the third world was so profound that the scientists who developed it won a Nobel Prize for the drug in 2015.
“Diseases caused by parasites have plagued humankind for millennia and constitute a major global health problem,” the Nobel Assembly at Karolinska Institutet wrote in 2015. “In particular, parasitic diseases affect the world’s poorest populations and represent a huge barrier to improving human health and well-being.”
So, the fact is, ivermectin has been used in humans for decades. Yes, the same drug is also used in veterinary medicine, but it is not exclusively for animals.
Certainly, that laudatory history did not stop the the illicit campaign to cajole Americans into thinking that ivermectin is only for horses and cows.
The FDA took to Twitter in August 2021, writing, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
You are not a horse. You are not a cow. Seriously, y’all. Stop it. https://t.co/TWb75xYEY4
— U.S. FDA (@US_FDA) August 21, 2021
It was that post that doctors said amounts to illegal government interference in their right to prescribe ivermectin for their patients — especially since the FDA itself had years ago approved the drug for use in humans here in the U.S.A.
This case was originally dismissed by a Trump-appointed judge in 2022, but the doctors appealed to the Fifth Circuit, and that case was heard in early August.
“The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no,” Jared Kelson, who is representing the doctors, told the appeals court, according to Courthouse News.
The doctors added that when the FDA told people to “stop it,” that amounted to a demand from a government health agency to stop prescribing, using, and selling ivermectin. And in many cases, that is exactly how doctors, hospitals and pharmacies took it — as a command to ban the drug issued by a government agency.
The agency also posted a long, involved warning to its website with an article entitled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
The FDA, though, claimed that with its offhanded tweet the agency was just trying to issue a “quippy tweet meant to share its informational article” and the “stop it” command was just a fun way to relay their concerns about the drug, the Epoch Times reported.
The tweet and its other statements “don’t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose,” FDA lawyer Honold told the court.
“FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So they are not interfering with the authority of doctors to prescribe drugs or to practice medicine,” Honold added.
The judges were not convinced that the FDA was merely trying to inform.
“What about when it said, ‘No, stop it’?” asked Circuit Judge Jennifer Walker Elrod. “Why isn’t that a command? If you were in English class, they would say that was a command.”
The plaintiffs added that the FDA has never been allowed to offer medical advice, and they said the FDA’s actions to undermine ivermectin is exactly that. The FDA, the lawyers said, didn’t just offer information, they actively offered advice to “stop” using the drug.
This was a point that most of the judges on the panel seemed inclined to agree with. Judge Edith Brown Clement, for instance, said, “You’re not authorized to give medical advice.”
Whatever the government agency meant then, it is clear that now the FDA has quietly rewritten its “information” page. Its new page is far more dispassionate about the use of ivermectin.
Indeed, on its original page, the FDA used phrases like “can cause serious harm” and “please beware,” and called use of the drug an “unconventional treatment.” In short, the original page was filled with words and phrases that could certainly scare people away from the drug. Much of that language, though, is now gone in the updated page.
The new page also added a line at the end, saying, “Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can help determine the best option for you, based on your health history.” It is a line that can be construed to mean that the FDA is leaving the use of ivermectin up to your doctor. This is a line that was entirely absent in the original post.
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