Pharmacy Magazine in the United Kingdom recently reports on the positive attributes of ivermectin. For example, the drug is included in the WHO Model List of Essential Medicines and more interestingly, and perhaps controversially for some, the UK online media reports on the recent British Ivermectin Recommendation Development (BIRD) Group recommendation that the drug be immediately rolled out to the public for the prevention of COVID-19, at least on an emergency basis.
Why does this online media make this recommendation?
First and foremost, the drug at established human doses is safe, widely used to treat a number of human parasites since the 1980s. Since then, some 4 billion doses have been consumed by humans with what Pharmacy Magazine UK declares is a “good safety record with minimal toxic effects.”
What evidence backs their position?
Pharmacy Magazine shared the recent meta-analysis of 15 randomized controlled trials coupled with observational studies demonstrating significant safety and efficacy both for treatment and prophylaxis targeting COVID-19.
How many patients did this 15 trial meta-analysis cover?
Nearly 4,000 patients.
Do some studies show that ivermectin can be used as a prophylaxis?
Yes, Pharmacy Magazine reports that in one study the evidence reveals that the drug can be used prophylactically for healthcare workers or relatively confirmed cases. In one study, the risk of transmission was reduced by 88% as compared to the control group.
Are there any studies showing ivermectin can reduce the death rate of COVID-19?
Yes. The UK-focused media suggests that in one study ivermectin can reduce the risk of death by 83% as compared to the ‘no ivermectin’ arm of the study.
What about risk of progression or patient deterioration?
That as well according to the meta-analysis, which reveals the risk of deterioration can be reduced by about 50%
Is ivermectin authorized for use, either as emergency treatment or compassionate use targeting COVID-19?
Yes. Over 20 countries including Greece, Bulgaria, Macedonia, Slovakia and Czech Republic in the EU now include ivermectin in their COVID-19 management strategies. But as TrialSite has reported, this includes a number of South American countries as well as in states in India such as Uttar Pradesh.
What are investigational dosage regimens?
According to the online publication, dose regimens vary but prophylactic treatment includes two doses of 0.2mg/kg, 48 hours apart once per month. For out-patient treatment, a daily dose of 0.2 mg/kg for a maximum of five days is recommended.
Why isn’t ivermectin used more widely?
The great majority of regulations and national research agencies suggest more trial data is needed, and of a higher quality of data. They point out that the existing trials are either too small or not standardized enough in dosage amount or are subject to bias. Increasingly, numbers of experts speculate however that various economic interests are blocking true, open and honest debate about the potential of the drug. It could threaten a therapeutic market worth tens of billions of dollars per annum in sales.
What is the counter argument to the naysayers?
Dr. Tess Lawrie, author one of the leading meta-analyses and recent guest on the TrialSite Podcast, suggests that the meta-analyses results demonstrate safety and efficacy. Moreover, they argue the fact that some think there isn’t quite enough data is hardly a reason to stop the use of a life-saving drug.
They provide examples to drugs like remdesivir, authorized with less evidence than what various meta-analyses studying ivermectin demonstrate.
How can one learn more?
TrialSite is the leading independent media platform chronicling clinical trials in a bid to make research more transparent and accessible: with an ultimate goal of building trust in research to advanced biomedical research. Check out the website.
Call to Action: TrialSite reminds the U.S. audience that ivermectin is not authorized for COVID-19 and while the National Institutes of Health (NIH) changed their opinion to neutral, the U.S. Food and Drug Administration (FDA) came out with a statement advising against usage. TrialSite suggested the agency share more of the data behind this statement but also reminded those in America the FDA represents the law of the land when it comes to food and drugs.