Vilification of a remarkable drug

In February/March 2022, frontline physicians faced with a crush of sick patients with a novel virus of unknown lethality from Wuhan, China scrambled to find ways to treat them.

The urgency of the situation precluded waiting for the development of new drugs, so a desperate search began to find existing drugs that could be repurposed to treat SARS-CoV-2, the virus that causes the illness most commonly called COVID. The name stands for Severe Acute Respiratory Syndrome Corona Virus 2, to distinguish it from SARS-CoV-1, which also originated in China in 2002, but only caused a minor epidemic that remained largely confined to China. SARS-CoV-1 affected less than a dozen people in the United States. SARS-CoV-1 was probably from an animal source, in contrast to SARS-CoV-2, which has hallmarks of a laboratory origin. But that is a story for another time. 

With vaccines expected to take years to develop, existing drugs considered for treating COVID included antibiotics, anti-inflammatories, and several others, among them hydroxychloroquine and Ivermectin, a drug few in the U.S. had heard of.

Originally developed in Japan in the 1970s to treat parasites and worms in livestock, Ivermectin was subsequently found to be very effective in treating people with two of the most common and devastating tropical parasitic diseases in Third World Countries, namely onchocerciasis, also known as river blindness, and filariasis, a parasitic infection that causes elephantiasis. Ivermectin has nearly eradicated both diseases. 

Ivermectin’s use has expanded ever since. It has been used in humans since 1987 and it is on the World Health Organization list of “essential” drugs. Its impact in human health globally is regarded as on par with the discovery of penicillin. It is one of the safest drugs known, with such a low risk profile that it can be given even by non-medical personnel with minimal training. It is taken worldwide by an estimated 60-80 million people daily and billions of doses have been given. It is referred to by many as a true wonder drug. The two discoverers of Ivermectin were awarded the Nobel Prize in Physiology and Medicine in 2015. 

Ivermectin came on the radar when it was reported in early 2020 to have significant anti-viral activity “in vitro” (in the laboratory) against SARS-CoV-2. 

The big question was: would it work “in vivo,” i.e. in patients, as well? 

I don’t think anyone approached Ivermectin with any preconceived bias for or against its use for COVID. There was no financial incentive to promote it since its patent had expired and it was available extremely cheaply worldwide for pennies per dose. No company was going to score billions by promoting it. 

Reports by frontline physicians and public health officials around the world were encouraging. Significant reductions in illness and death were reported in India and Brazil, which adopted it widely. There was a learning curve, of course – when to administer, ideal dosage, duration of use, etc. From the start, Ivermectin was criticized for lack of rigorous, reputable studies, especially the most reliable of all – prospective, randomized clinical trials involving enough patients for long enough periods to draw definitive conclusions. What studies there were, were mostly observational with small numbers of patients, or poorly controlled. That was expected, given the unprecedented circumstances. 

What is both amazing and inexplicable, given the stakes, is that we still don’t have results of a well-designed, randomized study on Ivermectin for COVID. The PRINCIPLE Trial in the UK began in June 2021 by studying drugs to treat COVID. Two were antibiotics—azithromycin and doxycycline. Both were shown to be ineffective. Colchicine, an anti-inflammatory, was also ineffective. Hydroxychloroquine was not shown to be effective in hospitalized patients and was dropped from the trial. Another story for another day. Budesonide, an inhaled steroid used for asthma, was found to reduce recovery time by three days and possibly lessen the chance of hospitalization. The last two drugs in the trial were Favipiravir, an anti-viral used for influenza, and Ivermectin. The results on these two are still not available.

You would have thought that we would have at least a preliminary finding by now, given the scope and urgency of the COVID pandemic. Instead, crickets.

Considering the money and lives involved, you would think we would have the definitive answer to whether Ivermectin is useful for treating COVID or not.

The U.S. government has thrown trillions of dollars at a huge cost to the economy yet has not funded a proper study of the drug.

Pharmaceutical companies have made billions in profits from vaccines and novel new drugs increasingly found to have significant limitations and poorly understood long-term effects. They have done this with no liability thanks to emergency use authorization, which frees them from any legal responsibility for potential harms.

Those who have used Ivermectin have been consistently demonized and marginalized simply for trying their best to treat sick patients rather than just send them home. I prescribed Ivermectin freely in the early stages of the pandemic and even after the rollout of vaccines because the default policy of just telling sick people to go home and report to the emergency room when they were in extremis did not sit well with me. My wife and I took it when we developed Delta Covid and recovered uneventfully. 

I want to be very clear that I am not an anti-vaxxer, either for vaccines in general or for COVID vaccines. The latter have clearly been very successful in preventing serious disease and death, especially in the most vulnerable persons, the very elderly, and those with multiple co-morbidities, such as obesity, diabetes, and other chronic illnesses. 

I am unaware of any reputable physician who has claimed Ivermectin is a cure for COVID. Remember that it was first used clinically before vaccines or any new drugs were available. Even after vaccines became available, it was inevitable that many people would continue to get sick because they could not or would not take the new vaccines, and simply because it was going to take time to vaccinate a sufficient number of people to reach population immunity. This still left a void in treatment of early COVID. 

Remdesivir was heavily promoted, at great expense, until it wasn’t because it had minimal effectiveness and an unacceptable risk profile. Monoclonal antibody infusions required travel to an infusion site and were labor and equipment intensive. Monoclonal antibody infusions were pulled by the Biden administration in early 2022 because they were ineffective for Omicron Covid. Now we have Paxlovid (Nirmatrelvir + ritonavir), which is not FDA approved for any use, but has been given emergency use authorization for COVID, primarily for those at high risk of serious disease. Billions have already been spent on it despite surprisingly sketchy data as to its effectiveness, primarily from mouse studies. These were done by Pfizer, the company that makes it. Reports of rebound COVID in patients who have completed a course of Paxlovid are disturbing. 

Despite widespread use and a huge number of supportive reports from the U.S. and all over the world, the FDA and mainstream media persistently demonized Ivermectin and the doctors prescribing it. It is still commonly described in the mainstream press as a “horse de-wormer.” In a Twitter post in August 2021, the FDA made the following statement, “You are not a horse. You are not a cow. Seriously y’all. Stop it,” regarding the use of Ivermectin. The assertion that Ivermectin is exclusively or primarily a veterinary drug is misinformation of the type that the FDA is accusing others of. The wide, decades-long use of Ivermectin in humans is easily accessible public knowledge and the FDA stance against it makes sense only if we assume some underlying agenda other than public safety. 

It is true that Ivermectin has never been approved by the FDA for use in treating COVID. It is, however, a long-standing and accepted practice in medicine for doctors to legally and ethically prescribe drugs for uses other than what they are FDA approved for. This is called “off label use,” and there are countless examples of drugs that were approved for one use and found to be effective for other uses. The FDA has never stepped in to prohibit this type of use – until now. 

One interesting recent development in the Ivermectin situation is a lawsuit by three physicians who claim that the FDA interfered with their practice of medicine by telling the public not to take Ivermectin for COVID.  Plaintiffs in the case include Dr. Paul Marik, who began utilizing Ivermectin in his COVID-19 treatment protocol in 2020 (well before there were vaccines) while he was chief of pulmonary and critical care medicine at Eastern Virginia Medical School and director of the intensive care unit at Sentara Norfolk General Hospital. The FDA’s defense is that it only made a recommendation; it didn’t issue an order or regulation against Ivermectin. In point of fact, based on the FDA “recommendation” pharmacies everywhere refused to honor physician prescriptions for Ivermectin if the drug was being given for COVID, something unprecedented in my 42 years in medicine. 

I recently wrote in a blog post that the misrepresentation of Ivermectin as a “horse de-wormer” in the media was an example of fake news. Some readers took issue with this and stated that Ivermectin has been conclusively proven to be ineffective for COVID. If we are honest and evidence-based we must acknowledge that the final word on Ivermectin for treating COVID is not yet in as I wrote this. 

Sources: 

https://www.principletrial.org/news/the-principle-trial-two-years-on

https://youtu.be/bVf0d25Przs

https://www.theepochtimes.com/dr-paul-marik-spike-related-diseases-gaslighting-of-the-vaccine
injured-and-the-suppression-of-earlytreatment_4818954.html

https://www.theepochtimes.com/fda-says-telling-people-not-to-take-ivermectin-for-covid 19-was-just-a-recommendation_4873897.
html?utmsource=Morningbrief&src_src=Morningbrief&utm_campaign=mb-2022-11-20&src_cmp=mb-2022-1120&utm_medium=email&est=meeYegtFj%2BEjSdEVDfWwoF62VE8Kxpf4phPAnG5zfDwLGT8RmxFtfmcUB8afjk0%3D

Ivermectin a Wonder Drug https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740/

Ivermectin as anti-viral https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7172803/

Ivermectin Nobel Prize https://pubmed.ncbi.nlm.nih.gov/34466270/

My blog on fake news https://beyondplasticmd.com/florida-governor-desantis-is-
banning-books/fbclid=IwAR1Tl22bd7DTm1J13yTrtrfLKbvr4Td5vDTuudsz_ZP5Hgd6x6gJd46ejCw