What happened to ivermectin? | PharmaVoice

“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

That’s a tweet from the FDA from August 2021, at a time when the agency was trying to dissuade people from taking the anti-parasitic drug ivermectin to prevent or treat COVID-19. That summer, ivermectin was at the center of a widespread misinformation campaign claiming that it was an effective treatment for the virus. Although ivermectin is approved for some human uses, it’s mostly used in animals, and many people ended up taking farm animal-sized doses of the drug to toxic effects.

Eventually, study after study showed that ivermectin wasn’t an effective treatment for the virus and the furor seemed to die down. It appeared that ivermectin had faded into the weird fever dream of COVID-19 confusion, division and misinterpretation of science.

But the ivermectin drama isn’t over. The drug and the FDA’s reaction to it are back in the news after a federal appeals court ruled that three doctors can continue a lawsuit against the FDA for its outspoken efforts to discourage ivermectin use.

The plaintiffs claim that the FDA’s anti-ivermectin campaign overstepped the agency’s authority and damaged their reputation in the process. Although a lower court had earlier said the lawsuit couldn’t continue, a federal appeals court reversed that decision, writing, “FDA is not a physician. It has authority to inform, announce and apprise — but not to endorse, denounce or advise.”

One of the plaintiffs, an ear, nose and throat doctor who the Associated Press reported was suspended from Houston Methodist Hospital because of social media posts containing false COVID-19 information, tweeted last week that the decision was a “small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny.”

How it started

The idea that ivermectin might be a COVID-19 treatment started with a 2020 study from researchers in Australia showing that “ivermectin inhibits the replication of SARS-CoV-2 in vitro.”

The key phrase here, of course, is “in vitro” (the scientists did their study in a lab, not the human body), and there are a lot of steps between proving something works in a petri dish and proving it’s safe and effective in humans. For instance, although bleach will kill COVID-19 on surfaces, it would be unwise to ingest or inject it.

But many people latched onto the idea of ivermectin as a COVID-19 treatment anyhow, perhaps proving the adage that “a little knowledge is a dangerous thing,” and by the summer of 2021, ivermectin was all over the news and social media, with everyone from Rand Paul to Jimmy Kimmel weighing in.

Meanwhile, calls to poison control centers skyrocketed as people tried to DIY their own ivermectin treatments using products and doses intended for animals — sometimes large animals — while farmers, ranchers and veterinaries reported shortages of the drug.

Where we are

The authors of the Australian study said their results showed that ivermectin “warrants further investigation for possible benefits in humans,” and additional studies did follow. But none of them showed any clinical benefit for using ivermectin to prevent or treat COVID-19.

Additionally, one retrospective study that showed an “association of ivermectin with reduction in mortality in COVID” had many limitations and was eventually retracted by its authors, who wrote in their retraction that their study had been “misinterpreted” by people in both the scientific community and the general public.

“We know that a retrospective study like ours cannot be used to change or guide clinical practice. Retrospective studies are only helpful to formulate hypotheses that can be utilized to design clinical trials,” they wrote. “This misrepresentation of the study may lead to a huge public health problem, since ivermectin is a medication that is not FDA-approved for COVID treatment, and currently has proven to be ineffective in clinical trials, which are truly the gold standard to evaluate the efficacy of a medication.”

That strongly worded retraction didn’t matter, though. The genie was out of the bottle, and even today, people are fighting for access to ivermectin as a COVID-19 treatment.