The FDA is busy emphatically reminding us that several promising off-label drugs haven’t been approved for therapeutic use against COVID. The approved for humans, anti-parasitic drug ivermectin, is the topic here. Criticism and comments from the FDA and other naysayers are numerous and colorful.
From MSN.com: “Why are people taking horse medication for COVID-19 infections?” The NY Post: “People taking horse, cow de-wormer for supposed COVID-19 treatment.” MSNBC’s Rachel Maddow repeated reports of veterinary drug overdoses. Her colleague Joy Reid scoffed at people self-medicating by ingesting “horse paste.” USA TODAY reported on prominent podcaster Josh Rogan being prescribed deworming medicine. CNN referred to it as “horse-dewormer.” They all seem to avoid the part about ivermectin being approved and safe for human use.
Making matters worse, the FDA tweeted “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” That’s a cruelly misleading official warning and has been widely exploited. And the “horse-paste” story lives on.
The source of some reports came from an inaccurate Rolling Stone article that was later corrected. A doctor told a local news station that Oklahoma hospitals were overrun by patients overdosing on ivermectin and gunshot wounds were being neglected. The hospital referred to in the story rebutted the claim by reporting the quoted doctor hadn’t practiced there for months and had never treated ivermectin overdoses.
The animal formulation of ivermectin originated in the 1970s. The human anti-parasitic version was approved in 1996. In 2015, scientists who developed ivermectin won the Nobel Prize in Physiology and Medicine. The drug “revolutionized therapy for patients suffering from devastating parasitic diseases.” But how about use fighting COVID?
Even though the FDA hasn’t evaluated ivermectin for COVID treatment, much supportive information is available on government websites. Here’s a sampling:
• …Ivermectin, an FDA-approved antiparasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2)…Ivermectin therefore warrants further investigation… https://pubmed.ncbi.nlm.nih.gov/32251768/
• …more than 20 randomized clinical trials have tracked such inpatient and outpatient treatments. Six of seven meta-analyses…found notable reductions in COVID-19 fatalities… https://pubmed.ncbi.nlm.nih.gov/34466270/
•…Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality…time to clinical recovery… American Journal of Therapeutics https://ncbi.nlm.nih.gov/pmc/articles/PMC8088823/
Clarification of abbreviations: PMC=PubMed Central, nlm=Nat. Library of Medicine, ncbi=Nat. Center forBiotechnology Info, nih=National Institute of
There’s much supportive data, but the FDA doesn’t seem inclined to officially investigate ivermectin’s efficacy. Some confusion may have come from the disconnect created from recommending an anti-parasitic drug for use in treating a virus. I read an explanation stating that ivermectin’s effectiveness comes from acting upon cells to help them accept anti-viral drugs which inhibit virus replication. I’ll leave further explanation to experts.
If a doctor or institution is convinced a safe, off-label drug had lifesaving potential, why wouldn’t they simply step up and start using it. Here are excerpts from retired physician Dr. Ted Noel ‘s 9/22 article in American Thinker: “The failure of the CDC to endorse any treatment that did not emanate from its exalted halls should give us our first glint of clarity…Ivermectin isn’t on the Medicare/Medicaid approved list…for COVID…The financial risks (of prescribing it) may be extreme.” Therefore, if the physician or group flunked government protocol, a charge of “fraud” is quite likely.
Many credible medical professionals believe in the effectiveness of ivermectin for battling COVID. Contrary to the mocking and criticism, much of the privately gathered information is more than just wishful thinking.
During a pandemic, pharmaceutical companies and their government regulators should shift thinking from “peacetime” to “wartime” protocols and processes. That should apply to off-label therapeutics, not just vaccine development. It’s a tragic embarrassment that this investigative responsibility has been relegated to others, who then struggle to get attention, let alone approval.
We’ve spent far too little energy exploring the lifesaving therapeutic potential of off-label drugs, while wasting far too much energy on political squabbling. I pray we’ve learned a lesson.