Question: I got this note from a doctor at my daughter’s elementary school recommending that we all follow the “I-MASK+ protocol for COVID prophylactic and treatment.” The doctor went on saying that he and his wife are “taking the prophylactic ivermectin as it’s been shown to prevent transmission, and recommending everyone to do so at this point.” Is this quackery?
Answer: Yes, this ivermectin recommendation is quackery. Science is a step-by-step process. If you jump too far ahead of the evidence to form conclusions, you can do great damage, including by exposing people/patients to drugs/treatments that have detrimental effects. Self-medicating with a new drug can be really dangerous (ex: drug-drug interactions can be dire)! That’s why it’s so important to base medical guidelines on our best science. It’s also why we should never recommend that people self-medicate with a drug that is new to them and unproven for the purpose. I’m not saying this to put the kibosh on our study of ivermectin. We absolutely should be (and are) studying ivermectin as a potential COVID treatment– clinical trials will give us the data we need to develop the best treatment guidelines. Until we have that solid evidence base, please avoid the type of “medical guidance” your daughter’s school doctor shared. Read on for more information about ivermectin and COVID-19.
- Safety/efficacy are unknown. The National Institutes of Health COVID Treatment Guidelines Panel “recommends against the use of ivermectin for the treatment of COVID-19, except in a clinical trial.” The Food and Drug Administration (FDA) warns against ivermectin use, including for COVID prophylaxis, stating “Any use of ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established. Data from clinical trials are necessary for us to determine whether ivermectin is safe and effective in treating or preventing COVID-19.”
- Approval is not granted. Ivermectin is used in tabular form to kill parasites and in topical form to stop diseases like scabies. While it is FDA-approved as an antiparasitic drug, it is not approved for treatment of any viral infection. Scientists have yet to find evidence in animal studies or human trials that it can treat viral diseases.
- Side effects can be severe. As FDA also states, “Some of the side-effects that may be associated with ivermectin include skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests.”
- Dosage required is huge. While ivermectin has been shown to inhibit SARS-CoV-2 replication in cell cultures (lab studies), the amount of ivermectin needed to inhibit SARS-CoV-2 in the human body is estimated to require doses up to 100-fold higher than those approved for use in humans.
- Doctor touting ivermectin has been debunked. One of the leaders of the “I-MASK+ protocol” is Dr. Paul Marik, who has a reputation for inappropriately elevating small, observational studies as revolutionary scientific advances. For example, Dr. Marik is known for having developed a treatment for sepsis based on a very small retrospective study of 47 patients. Over the last several years, across the lay press and medical education blogs he has promoted his treatment as the definitive. The findings– that a cocktail of vitamin C, corticosteroids and thiamine would dramatically reduce sepsis in ICU patients– were recently refuted thanks to a randomized control trial, results from which were published in JAMA earlier this year.
If you’d like to read more about ivermectin, here are a few more informative resources:
- NIH COVID Treatment Guidelines: Ivermectin
- FDA Ivermectin FAQ
- Pan American Health Organization: Ivermectin Recommendations
- Associated Press Ivermectin Fact Check
- NY Times Coronavirus Drug and Treatment Tracker
- Nature article, “Latin America’s embrace of an unproven COVID treatment is hindering drug trials”