The U.S. Food and Drug Administration (FDA) commissioner on April 11 said that ivermectin does not work at all against COVID-19, just days after his agency deleted social media posts that had urged people not to use the drug as a COVID-19 treatment.
“If you look at the randomized trials of ivermectin, and there’s many of them now, there is no benefit of ivermectin in the treatment of COVID,” Dr. Robert Califf said in Washington during a congressional hearing.
He also said there were risks to taking the drug.
The comments came just days after the FDA removed posts describing ivermectin as a horse drug and urging people not to take it against COVID-19. The action came under a settlement reached with doctors who sued the agency over the posts and a related webpage that was titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” That page was also taken down.
“Why did you have to retract everything you said about ivermectin?” Rep. Paul Gosar (R-Ariz.) asked Dr. Califf on Thursday.
“We didn’t retract everything we said about ivermectin,” Dr. Califf said. That’s when he claimed no randomized clinical trials showed a benefit for ivermectin as a COVID-19 treatment.
“That’s a statement just in fact,” he said. “And any drug for which there’s no benefit and there are risks, people have to make their own decisions about what to do. What we’re not doing is telling doctors what they have to do.”
Dr. Califf’s comments are false. While some randomized trials have not found a benefit for ivermectin, others found ivermectin takers were better off than people in comparison groups.
Dr. Janet Woodcock, Dr. Califf’s predecessor, was more targeted in her comments about ivermectin when responding to the mixed data. “Ivermectin has been shown to be ineffective against COVID in large randomized trials,” she told The Epoch Times previously.
“I would urge Dr. Califf to engage in debate with myself or other doctors who are actually treating COVID patients using ivermectin,” Dr. Mary Talley Bowden, one of the doctors who sued the FDA, told The Epoch Times in a message on the social media platform X.
“Dr. Califf has zero hands-on, clinical experience and is somehow ignorant of the 102 peer-reviewed studies showing efficacy of ivermectin in COVID patients. Further, if he would take the time to refer to the FDA’s own data, he might understand how safe ivermectin is,” she added.
Ivermectin is approved by the FDA for certain uses, including as a treatment for strongyloidiasis, a disease caused by roundworms. Doctors in the United States can, and often do, prescribe drugs approved for one purpose for another purpose.
Misinformation?
Dr. Califf, since becoming commissioner of the FDA again in 2022, has repeatedly railed against misinformation. He has claimed that misinformation is the leading cause of death in the country. He has not presented data backing the claim.
Rep. Eric Burlinson (R-Mo.) confronted the commissioner with his past remarks and showed an image of one of the ivermectin statements the FDA had posted online. The statement was: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
“Even to this day, you have to correct misinformation about ivermectin,” Mr. Burlinson said.
“Pretending that ivermectin is dangerous or claiming that it’s horse medicine, would you not agree that that’s the exact definition of misinformation?” he asked.
“I would not agree with that,” Dr. Califf said.
He noted that the drug is also available to animals, although he acknowledged the human form won the Nobel Prize and that it has been used widely in humans.
In a back-and-forth afterwards with another lawmaker, Dr. Califf repeated the lie that no clinical trials have returned positive results for ivermectin.
“Ivermectin has been studied multiple times in randomized trials. No benefit,” he said.
The false portrayal of the drug as merely for animals was utilized widely by critics, including news outlets who would report that people who took ivermectin were using a “horse dewormer.”
Ivermectin “is an animal de-worming agent that some people were advocating for use to treat COVID-19,” Rep. Jamie Raskin (D-Md.) said during the hearing.
“It also has a benefit for humans in worms,” Dr. Califf said. He said that “there was good reason to think it may work in the case of COVID” but the trials didn’t show a benefit.
The legal settlement required the FDA to remove two webpages and delete several social media posts, but stated that the agency was “retaining the right” to post a revised page on ivermectin.
On its new page, the FDA says that “the FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals” and that “the FDA has determined that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID 19 in humans.”
It also says: “Health care professionals may choose to prescribe or use an approved human drug for an unapproved use when they judge that the unapproved use is medically appropriate for an individual patient. If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy.”
From The Epoch Times
