Why the Scientific and Medical Community Object to those who are Touting Ivermectin for the Prevention or Treatment of COVID-19

The scientific and medical community want the COVID-19 pandemic to end just as much, and likely more than you do. First of all, preserving health and life is why we all went into these professions. Second, we are tired and exhausted. Not only have we been subjected to the same limitations on our own activities and family get togethers as you have, but we have been caring for COVID-19 patients for almost two years now, under some of the most difficult of circumstances. If there was a magic pill that would prevent people from getting COVID-19 and treat patients with COVID-19 to prevent our hospitals from being overwhelmed, believe us, we would be the first ones championing it and promoting it to the public and prescribing it to our patients and taking it ourselves. Keep in mind that all of us worry about getting infected when we are seeing patients and inadvertently bringing the virus home to our families. So, no way would we try to prevent our family, our friends and neighbors and our communities from having access to a medication that would keep them healthy or save their lives.

• The primary reason that we do not support the treatment of people with ivermectin for COVID-19 is that we have no high-quality studies that point to its benefit in either preventing or treating COVID-19. Those who advocate for the use of ivermectin will point to various studies that seem to suggest a benefit. However, that is not how we make treatment decisions for patients who have serious threats to their health or for whom we are recommending a medication that can have adverse effects such that the old adage might apply of the treatment being worse than the disease. We evaluate those studies to determine whether they are of high quality, in other words, results that can be trusted. This is why you will hear the phrase “peer review.” This is a rigorous process in which experts in the field review the study design, the size of the study, the process by which participants in the study were divided into the group that would receive the medication and the group that would not to make sure we are really comparing apples to apples, the data collected during the study (including the proper statistical analysis) and the conclusions drawn from those data. Unfortunately, it is not uncommon for studies to have major flaws in one or more of these elements that undermine the validity of the study or the confidence we can have in the results. Most alarming is when the authors of the study are contacted during this peer review process, but refuse to engage with the peer reviewers or their data doesn’t seem right and those peer reviewers request the data, but the request is declined. There was some of all of these concerns in most of the studies that those who advocate for ivermectin base their recommendation upon. For a very nice summary of the clinical trials that are among the better designed studies with an explanation of the findings and limitations of those trials, see https://www.covid19treatmentguidelines.nih.gov/tables/ivermectin-data/.

• Much of the excitement about a potential therapeutic benefit for ivermectin comes from studies showing an antiviral effect of ivermectin in a test tube. In fact, this is not new information. This test tube result led to enthusiasm for the possible benefit of ivermectin to treat many other viruses in the past such as the viruses that cause HIV/AIDS, dengue fever, Zika, and yellow fever. Given that many poor countries struggle with these diseases, the potential for an inexpensive pill to treat these infections was very exciting. The problem is that the benefits we see in the test tube did not occur in humans when we conducted clinical trials, and so far, we have not seen those benefits against the virus that causes COVID-19, either. It is not uncommon for benefits that we see in a laboratory do not occur when we test those treatments in humans. That is why the FDA never approves medications simply based on laboratory tests. There must be clinical trials involving humans to ensure that those treatments are safe when given to humans (you wouldn’t see adverse effects in test tube studies) and that they actually do provide a measurable benefit when given to humans. The reasons why a medication might seem to offer hope in a test tube, but not when actually administered to humans are many because the human body and the interactions of medications with all the fluids, cells and organs of the body can seldom be predicted in a test tube. In the case of ivermectin, one problem seems to be that the level of ivermectin needed to get the antiviral effect we see in the test tube cannot be attained in human cells without excessive doses and excessive toxicity.

• We aren’t saying that ivermectin should not be considered as a therapeutic option. We are saying that (1) it should be tried in the setting of well-designed clinical trials so that we can determine once and for all whether it has a benefit and (2) given there is no high-quality evidence to suggest benefit in either preventing or treating COVID-19, it is not responsible for those prescribing it to suggest to patients that they can rely on this drug instead of those public health measures and therapeutics that do have proven benefit in either preventing or treating COVID-19.

• There is a large NIH (National Institutes of Health) -sponsored trial currently underway to evaluate ivermectin’s effect on the treatment of persons with COVID-19 who do not require hospitalization. We hope to have preliminary results as soon as March of 2022.

• The biggest threat caused by many who tout ivermectin is not the prescription of ivermectin itself, it is the fact that they often encourage the use of ivermectin as an alternative to measures that are proven to help prevent COVID-19 (e.g., masks and vaccines). Unfortunately, we all too often hospitalize people who were told not to get vaccinated and that ivermectin would protect them.

• FDA – Ivermectin is neither authorized or approved for use in preventing or treating COVID-19. In fact, the FDA has warned against its use https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19.

• Unfortunately, because there are some who promote ivermectin as safe and very effective in preventing or treating COVID-19, some people have resorted to ways other than being evaluated by a physician to get the drug that are not safe. As with most things that get promoted and have high demand, a black market emerges to sell products advertised as ivermectin that do not have the same safety oversight and for which the ingredients cannot be guaranteed. Others have turned to veterinary suppliers of ivermectin for animals, without understanding that the dosage recommendations for a horse can be very dangerous for humans.
• Bottom line:
• World Health Organization (WHO) recommendation: ”We recommend not to use ivermectin in patients with COVID-19 except in the context of a clinical trial. (Recommended only in research settings).” https://app.magicapp.org/#/guideline/nBkO1E/section/LAQX7L.

• National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel has also determined that there are currently insufficient data to recommend ivermectin for treatment of COVID-19 https://www.covid19treatmentguidelines.nih.gov/.

• Centers for Disease Control and Prevention (CDC) has warned of severe illness resulting from the use of products containing ivermectin https://emergency.cdc.gov/han/2021/han00449.asp.

• The American Medical Association recommends against the use of ivermectin https://www.ama-assn.org/delivering-care/public-health/why-ivermectin-should-not-be-used-prevent-or-treat-covid-19.

• The Infectious Diseases Society of America (IDSA) recommends that ivermectin not be used for inpatients or outpatients outside of the context of a clinical trial.

• The American Academy of Clinical Toxicology recommends against the routine use of ivermectin https://www.clintox.org/news/aact-recommends-against-the-routine-use-of-ivermectin-for-treatment-for-covid-19.

• Here is the most damning argument against taking ivermectin. The pharmaceutical company that makes ivermectin would stand to make huge profits if sales of its drug were promoted across the world for prevention and treatment of COVID-19. Despite this, the company has warned the public not to take its drug for this purpose because even its own scientists have seen no credible evidence that the drug has these benefits. https://www.merck.com/news/merck-statement-on-ivermectin-use-during-the-covid-19-pandemic/. It is instructive to read the results from Merck’s own analysis of ivermectin for COVID-19:
• No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; 
• No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and; 
• A concerning lack of safety data in the majority of studies.

Frequently asked questions:

1. There are doctors claiming that they have treated hundreds of patients with ivermectin who have all done well. Why isn’t this good enough evidence for the use of ivermectin?

These are called anecdotes and they are not strong enough for us to make medical decisions based on them. As an example, if I were to tell 100 of my friends to eat 10 M&Ms a day, they did so, and none of them ended up hospitalized with COVID-19, we should not jump to the conclusion that M&Ms prevent severe disease. When we are dealing with a disease like COVID-19 for which a large number of people get asymptomatic or mild disease, it would not be surprising if these doctors were treating 100 or 200 healthy, young adults with ivermectin that they would not develop serious illness, and would not have developed severe illness even if they weren’t taking ivermectin.

2. What would be the harm in taking ivermectin?

While the majority of people would probably tolerate prescription strength ivermectin perfectly well, like all medications, some will experience adverse reactions. But, the bigger harms are not related to the ivermectin itself. If it turns out that ivermectin is not effective, will people taking ivermectin take chances they otherwise would not assuming that they are being protected by the ivermectin only to end up sick and perhaps severely so? Are people taking ivermectin to prevent COVID-19 instead of the vaccines that are proven to help prevent COVID-19? One doctor who touts the benefits of ivermectin got infected with COVID-19 and indicated that it was likely due to the fact that he missed a couple of doses of the medication while traveling. Patients often miss doses of their regular medicines. If missing just a couple of doses of ivermectin can lead to infection, how practical of a solution is ivermectin compared to getting vaccinated? If you have to continue taking ivermectin for years to prevent getting infected, then that will add up in costs for a medication that has no evidence of benefit and further, we do not know the long-term adverse effects of ivermectin, since ivermectin is intended for short courses of treatment of certain conditions.