Perhaps it was the Front Line COVID-19 Critical Care Alliance (FLCCC) meeting with the National Institutes of Health (NIH) COVID-19 Treatment Guideline Panel that influenced the apex research agency to make a change to their formal stance on the anti-parasite drug ivermectin? That NIH published a statement on Thursday, January 14 titled, “The COVID-19 Treatment Guidelines Panel’s Statement on the Use of Ivermectin for the Treatment of COVID-19” possibly indicates change is afoot. Meant to offer interim guidance as the panel formally updates their treatment Guidelines, the NIH changed their recommendation from against the use of ivermectin for the treatment of COVID-19 except in a clinical trial to not recommending either for or against the use of the drug for the treatment of COVID-19. The NIH calls out the need for more evidence from well-designed clinical trials. Noteworthy because the FLCCC was informed at their meeting with the NIH that the guidelines would be updated sometime by February. So, why publish this statement immediately after the FLCCC meeting? Some physician/commenters, such as “The Whiteboard doctor,” suggest the NIH is offering both physicians and patients the opportunity to consider the treatment. Those providers that have confidence in the efficacy of COVID-19 as a treatment, and for that matter patients that seek the drug, suggest this interpretation opens the door for more off-label prescribing. Meanwhile, the FLCCC, based on its current meta-analysis, continues the pursuit of the ivermectin initiative, establishing a larger following by the day. They are, of course, collaborating with a group with a comprehensive ivermectin meta-analysis in the UK led by Dr. Andrew Hill. Looking at ivermectin as a possible treatment for early onset of COVID-19 as well as potentially a prophylaxis, the FLCCC now tracks to 27 controlled trials, 16 of them are randomized; five double blinded and one single blinded. But the NIH Panel is clear that more trial data from properly designed trials is of paramount importance. Yet other treatments authorized for emergency use by the U.S. Food and Drug Administration (FDA), such as convalescent plasma or monoclonal antibodies, perhaps involve less positive data. After all, ivermectin is already approved by the FDA and has been in use to fight various parasites for decades. One key question is dosage which large, well-designed trials address. In other good news, the FLCCC’s recent manuscripts passed a rigorous peer review with frontiers in Pharmacology. Finally, the FLCCC’s Dr. Pierre Kory engaged with radio talk show host Hugh Hewitt to discuss the FLCCC research. Dr. Kory believes that global research agencies and regulators are only a few months away from arriving at what will represent the logical outcome based on the mounting data—a positive decision to support the use of ivermectin along with other mission-critical efforts, including vaccination.
TrialSite Offers a brief update on the unfolding ivermectin saga during the COVID-19 pandemic.
NIH Issues Statement while Updating Guidelines
The NIH COVID-19 Treatment Guidelines Panel (the Panel) recently met with the FLCCC, along with Dr. Andrew Hill, to learn more about the recent meta-analyses associated with ivermectin studies. Although one the one hand the Jan. 14 declaration could be interpreted as a disappointment, on the other hand TrialSite considers it a positive move by the Panel to take the time to update the ivermectin recommendation. They didn’t have to publish any statement. It’s frankly a surprise as they indicated there would be updates sometime in February. This influential group is digging in, reviewing data from around the world made possible by dedicated researchers and patients from Bangladesh and Argentina to Spain and Egypt. The research to clinic chasm became apparent during the pandemic but the NIH, considered the “ivory tower” by many, now demonstrates it’s more lean, agile, innovative, and potentially more unorthodox as the Panel does understand the implications of life and death.
NIH Main Argument; Not Enough Powerful Enough Data
While the NIH’s move evidences an acknowledgment that a number of studies, some of which have been published in peer review journals, actually showcase data that could be construed as positive (e.g. shorter time to resolution of disease symptoms associated with COVID-19; bigger reductions in inflammatory markers and shorter time to viral clearance or lower mortality rates), they also duly point out that some clinical studies are interpreted as not showing benefits associated with the drug.
At the core of NIH’s cautious position are elements the Panel would point out in any decision, including 1) a majority of sample size are considered small, 2) dosage regimens not harmonized, 3) some of the studies were open—hence no blinding, 4) combinations with other medications such as doxycycline confounding evaluation of actual efficacy and safety of the drug, and 5) study outcomes measures were at times not well defined.
Consequently, the NIH cannot from their vantage promulgate a positive recommendation in regards to ivermectin safety and efficacy for the treatment of COVID-19. What will it take to get this incredibly influential Panel to change the recommendation? Produce more positive data from better designed, sufficient powered clinical trials. Noteworthy, however, is the January 14 declaration—establishing a precedent that they do not recommend against as well.
Hugh Hewitt Interview
Hugh Hewitt invited Dr. Pierre Kory to present the FLCCC’s meta-analysis findings. As it turns out, Hewitt was exposed to COVID-19 and was actually given ivermectin by his doctor. Acknowledging this controversial nature of ivermectin, Hewlitt’s toxicologist believes more testing is required. How did this interview go? Check it out!