The ongoing ivermectin discussion in association with COVID-19 has spread rapidly to America’s Western Plains as local journalists from regional publications now interview physicians from the Front Line COVID-19 Critical Care Alliance (FLCCC). Most recently, journalist Lacey Newlin writing for the High Plains Journal in Dodge City, Kansas, introduced the FLCCC’s accumulation of clinical trial data, amounting to at least 24 randomized controlled trials now. According to the FLCCC analysis of existing data, the drug can inhibit SARS-CoV-2, the virus behind COVID-19 at safe dosages in humans. This controversial position is not accepted by the relevant government agencies, such as the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Interviewing FLCCC physicians Dr. Paul Marik and Dr. Pierre Kory, the Kansas-based newspaper journalist brings an intensifying debate to this part of the country: can a common anti-parasite drug used primarily for livestock and tropical parasites in humans support the mission-critical need for early onset treatment of COVID-19? On the one hand, the FLCCC physicians argue that mounting data from randomized controlled trials point to a clear case for FDA emergency use authorization (EUA) as well as publicly subsidized clinical trials (NIH and Operation Warp Speed have allocated $13+ billion to a handful of vaccine and monoclonal antibody developers). However, on the other hand, the NIH at least until now hasn’t observed such evidence or justification to change their guidelines. Presently, NIH’s COVID-19 Treatment Guidelines Panel recommends against the use of the drug for treating COVID-19, except for clinical research. However, recently, and to the NIH’s credit, they just last week invited the FLCCC physicians to present to their Panel. During the meeting, the NIH’s Panel indicated it would update its Treatment Guidelines by February.
COVID-19 Rages in the Western Plains of America
The second wave of COVID-19 hasn’t spared Kansas with 5,180 reported cases by last Friday. The Kansas Department of Health and Environment reported 94 new hospitalizations and 107 new deaths. Some good news: the actual percentage of individual tests reading positive went down 12.7% from last month.
Ms. Newlin introduces Kansas-based readers to a drug that just a year ago was quite non-controversial—one variety of the substance back then was known for livestock while another variety was considered a “wonder drug” for its ability to treat topical parasites. But along came some brilliant researchers from Australia that had a hunch.
The FLCCC physicians informed Ms. Newlin about the amazing finding back in early April at the University of Monash in Australia. There researchers found in a lab cell culture that ivermectin absolutely destroyed SARS-CoV-2 within 48 hours.
Newlin has shared this knowledge with Kansas readers along with the NIH’s suggested explanation as to why the drug could be impactful. She shared that the drug “impedes the host importin alpha/beta-1 nuclear transport proteins.” These represent a “…central part of the intracellular transport process that viruses seize to increase infection by pacifying the host’s antiviral response.” Hence the NIH refers to ivermectin as a “host-directed agent.” This explains the efficacy with broad-spectrum activity in vitro against what are actually a number of viruses.
Questionable Concentration Levels?
Undoubtedly, the NIH’s rationale for not embracing the drug earlier during the pandemic came down to the reality that there was no real traditional preclinical safety research. They would certainly refer to the Monash cell culture study showing that producing the right level of antiviral effect involves amounts up to 100 times the amount currently approved by the U.S. FDA.
TrialSite started chronicling each and every Ivermectin study around the world after the Monash finding. Essentially many primarily developing world patents become essentially subjects in an ongoing real-world laboratory. This, of course, occurred under pandemic conditions and doctors used doses that were already approved by authorities in their respective countries, whether India, Peru, Bangladesh, Brazil, etc. But the studies started accumulating, from case series and observational study, to what is now over 50 total randomized controlled studies; 24 of which are at least already completed.
But was study data from low-income to middle-income countries adequate for developed world health research agencies and regulators? The FLCCC and a growing number of researchers and doctors think the data substantial and actionable—not the regulators and health research agencies, such as the NIH. But with the NIH’s invitation to FLCCC physicians, perhaps this will change?
Call to Action: Follow the link to Ms. Newlin’s piece in the High Plains Journal.