Although a few European Union Bloc nations authorized temporary use of ivermectin, including Slovakia and Czech Republic as well as Macedonia, the European Medicines Agency (EMA) has recommended against the use of ivermectin for the prevention except for use in clinical trials. EMA declared that they reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials. EMA has taken the exact same narrow approach as the U.S. Food and drug Administration (FDA), while TrialSite at least applauds the U.S. National Institutes of Health (NIH) that after a more thorough and wide-ranging review of the dozens of ivermectin studies completed, as well as an invitation to a group of researchers recommending the use of the generic drug based on comprehensive meta-analyses, that they changed their recommendation from an oppositional one to a neutral stance as to not recommend for or against its use outside of clinical trials.
EMA didn’t review the ivermectin studies as thoroughly as the NIH, showcasing a more narrow process to come to their conclusion. For example, they declared that the results from clinical studies were varied, with some studies showing no benefit and others reporting a potential benefit. Most studies EMA reviewed were small and had additional limitations, including different dosing regimens and use of concomitant medications. EMA therefore concluded that the currently available evidence is not sufficient to support the use of ivermectin in COVID-19 outside clinical trials. EMA’s main position for human is based on the original in vitro study in Australia while not appropriately acknowledging the true outcomes of the dozens of studies aggregated into key meta-analyses leading to the BIRD recommendations, for example. The majority of the nearly 40 studies involving ivermectin actually show safety and efficacy and there are myriad ways to overcome differences in the various studies as showcased by prominent meta analysis.
EMA, of course, acknowledges that ivermectin is generally safe and well-tolerated at doses authorized for other indications and cautions that side effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be excluded. But again EMA fails to dive deeper into the dozens of studies showing that perfectly safe doses are used with positive results.
And because EMA precluded a more open-minded, thorough and unbiased deep-dive review of those studies they therefore cannot recommend ivermectin for prevention or treatment of COVID-19 outside controlled clinical trials. They argue well-designed, randomized studies are needed to draw conclusions as to whether the product is effective and safe in the prevention and treatment of COVID-19.
EMA notes that their public health statement has been endorsed by the COVID-19 EMA pandemic Task Force (COVID-ETF), in light of the ongoing discussions on the use of ivermectin in the prevention and treatment of COVID-19.
TrialSite shares that EMA does refer to a TrialSite article in relation to the Slovakia situation.
Call to Action: Given the recent news from FDA and EMA, TrialSite’s position is that both FDA and EMA are taking very narrow, industry-centric views shunning low cost, generic repurposed drugs while expressing more open and opportunistic interpretations for industry-centric products. For example, while the pivotal WHO Solidarity trial shows remdesivir doesn’t help with COVID, this doesn’t stop FDA and EMA supporting the drug and the sponsor—this has led to over $3 billion in revenue in less than one year. The pandemic reveals a clear and present bias in favor of high-priced, experimental drugs over generic, repurposed, low cost drugs. Hence why Steve Kirsch put up the recent challenge to pay anyone $25,000 cash who can prove right now that Fluvoxamine doesn’t have all the evidence needed for authorization. TrialSite does share a new level of appreciation for National Institutes of Health for at least acknowledging key ivermectin studies and changing its rating to a neutral one.