Ivermectin and the FDA

The FDA Retreats from its War on Ivermectin

On July 28, 2021, David R. Henderson and I wrote in the Wall Street Journal about the U.S. Food and Drug Administration’s incorrect and misleading statements about the use of ivermectin to treat COVID-19.^[1]

The FDA clearly saw ivermectin as a threat.

First, there was the FDA’s humorous and popular tweet: “You are not a horse. You are not a cow. Seriously, y'all. Stop it.”^[2]

Second, the FDA issued a special warning on its website that “you should not use ivermectin to treat or prevent COVID-19.”^[3] The FDA’s warning, which included serious language such as, “serious harm,” “hospitalized,” “dangerous,” “very dangerous,” “seizures,” “coma and even death,” and “highly toxic,” might suggest that the FDA was warning against pills laced with poison. In fact, the FDA had already approved the drug years ago as a safe and effective anti-parasitic. The FDA didn’t address why it would suddenly become dangerous if used to treat COVID-19.

The FDA also claimed that ivermectin is not an antiviral, notwithstanding its activity against 21 viruses, including SARS-CoV-2, the virus that causes COVID-19.^{[4], [5]}

Interestingly, though, at the bottom of the FDA’s strong warning against ivermectin was this statement: “Meanwhile, effective ways to limit the spread of COVID-19 continue to be to wear your mask, stay at least 6 feet from others who don’t live with you, wash hands frequently, and avoid crowds.”^[6] Was this based on the kinds of double-blind studies that the FDA requires for drug approvals? No.

The six-foot distance was not based on any scientific data. Randomized, controlled trials before and after the pandemic have shown that wearing masks and washing hands have little effect on the transmission of respiratory viruses, such as SARS-CoV-2 and influenza.^{[7], [8]}

We received criticism from some who said we had exaggerated the FDA’s warning on ivermectin. We hadn’t. After our article was published, the FDA had changed its website, making no mention of the changes nor any reason for the changes. Overall, the warnings were watered down and clarified. We noticed the following changes:

• The false statement that “Ivermectin is not an anti-viral (a drug for treating viruses)” was removed.

• “Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too” was changed to the less alarming “Ivermectin has not been shown to be safe or effective for these indications.” (Indications is the official term used in the industry to denote uses for a drug, such as diseases or conditions, and/or patient populations.)

• The statement, “If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed,” was changed to, “If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.” This more clearly acknowledges that reasonable physicians may prescribe ivermectin for non-FDA-approved uses, such as COVID-19.

• The ending statement about masks, spacing, hand washing, and avoiding crowds was replaced with one that recommended getting vaccinated and following CDC guidelines.

• The reasonable statement “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” was added at the end.

The newer warning from the FDA was more correct and less alarming than the previous one.

On March 22, 2024, in response to a lawsuit from some doctors who claimed that the FDA had overstepped its authority by interfering with the doctor-patient relationship, the FDA has agreed to completely removed these controversial pages from its website.^[9]

The doctors have a good point.

As David R. Henderson and I wrote in the Wall Street Journal in May 2007, the FDA is supposed to judge whether a drug is safe and efficacious, and that's all.^[10] In its literature, the FDA even agrees with this role, saying that, "Once a new drug application is filed, an FDA review team—medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts—evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use." But the FDA sometimes slyly adds a third requirement: Does the FDA think the new drug is better than what's currently on the market?

Such a requirement isn't part of the FDA's legal mandate. And neither is the FDA’s war against ivermectin.

Doctors personally evaluate the medical history of each patient and compare the attributes of the products available for that particular patient, and any attempt by the FDA to interfere in that role shows how far the FDA has strayed from its original mission. Moving the FDA from approving safe and efficacious drugs to choosing them is no small transgression. Is the FDA saying that Americans and their doctors are so inept that they can’t properly choose and use drugs that the agency has already approved? If so, the FDA should come out and say it.

The FDA, like so many other government agencies, engages in mission creep. My response to the creeping FDA: “You are not a doctor. You haven’t personally examined individual patients to determine what is best for their situations. Seriously, y'all. Stop it.”

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^[1] https://www.wsj.com/articles/fda-ivermectin-covid-19-coronavirus-masks-anti-science-11627482393?mod=hp_opin_pos_1

^[2] https://twitter.com/us_fda/status/1429050070243192839

^[3] FDA consumer update, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” on FDA website.

^[4] https://doi.org/10.1016/j.antiviral.2020.104760

^[5] https://doi.org/10.1016/j.antiviral.2020.104787

^[6] https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

^[7] https://doi.org/10.3201/eid2605.190994

^[8] 10.1002/14651858.CD006207.pub6

^[9] https://www.theepochtimes.com/health/fda-settles-ivermectin-case-agrees-to-remove-controversial-stop-it-post-5612010?utm_source=Ccpv&src_src=Ccpv&utm_campaign=2024-03-23&src_cmp=2024-03-23&utm_medium=email&est=AAAAAAAAAAAAAAAAa%2B0jexALxs7M4bIA6jN5DLl7wk9AJCYD43aaojn%2B4HzlPrH5tFcMaA%3D%3D

^[10] https://www.wsj.com/articles/SB117936670505105766