Led by physicians affiliated with the Front Line COVID-19 Critical Care Alliance (FLCCC), a meta-analysis of 18 randomized controlled trials involving the generic drug ivermectin reveals a statistically significant reduction in mortality, time to clinical recovery, and time to viral clearance. The study, led by a group of dedicated front-line physician/researchers, also found that the results from a number of controlled prophylaxis studies indicate that the regular use of this economical, generic drug led to significant reduction of risk involving the transmission of SARS-CoV-2, the virus behind COVID-19. The authors showcase a number of public and privately funded ivermectin distribution programs that appear to correlate with population-wide decreases in morbidity and mortality. Does this meta-analysis indicate that ivermectin should be embraced as a primary research as a care option approach for early onset, mild-to-moderate COVID-19? How about additional prophylaxis studies? While mounting data indicates an overwhelmingly positive outlook, regulators, national research institutes, the World Health Organization (WHO), and the pharmaceutical industry have opted to take a “glass half empty” perspective. Is the world missing out on a chance to more comprehensively address and potentially contain the pandemic? After all, the NIH and others are on record that low cost therapeutic options are an absolute must in combination with mass vaccination and proper etiquette and public health measures to overcome the COVID-19 pandemic.
Considered provocative by the pharmaceutical industry—possibly due to the lack of profits involved with an ivermectin regimen—TrialSite has taken an objective, unbiased approach to tracking various investigational therapeutic approaches across the world. In fact, TrialSite was the first media platform to consistently track ivermectin study launches around the world.
The FLCCC’s Dr. Pierre Kory, Paul E. Marik, and others have been tireless crusaders for the consideration of ivermectin. They have no conflict of interest in this endeavor; they are not making money off of this pursuit. Rather, they believe wholeheartedly, based on the emerging data, that the evidence is there to progress with this drug as an emergency use option during this pandemic. In fact, they suggest that if we don’t use ivermectin, the death toll will just increase even with vaccination. These individuals should be respected and taken very seriously.
More Examples of Censorship?
Catherine Offord writing for The Scientist recently covered the “Frontiers” debacle where a bunch of authors, including the FLCCC team that authored this ivermectin-focused meta-analysis, prepared for a special edition of Frontiers in Pharmacology only to have the entire edition axed by chief executive editor Frederick Fenter who issued a statement defending his actions. Purportedly over a conflict of personality between the controversial Fenter (his journal has seen a lot of volatility with editorial staff) and a key guest editor over the specific mix of articles. But according to Dr. Pierre Kory, the peer review process went fine, even passing an unorthodox fourth reviewer.
Apparently, at the last minute, a mysterious biostatistician was concerned about bias and the entire repurposed focused agenda was terminated. The FLCCC authors are certain that this just represents the latest systematic attempts at censoring the ivermectin story, which would dramatically cut into a market worth several billion a year—that is, 90% of the COVID-19 patient base with asymptomatic, to mild and moderate symptoms. Companies such as Merck, (Molnupiravir), Pfizer (PF-07321332) and AstraZeneca (AZD7442) are gunning for this space and cannot tolerate any generic competition, goes the theory.
Fenter hit back against the authors arguing that at the last minute this biostatistician brought to his attention that somehow, despite four peer reviewers, that the article “…made a series of strong, unsupported claims based on studies with insufficient statistical significance, and at times, without the use of control group.” Fenter suggested that because Dr. Kory et al were actually promoting ivermectin as part of a protocol (off-label), which is legal and acceptable in the United States, but that violated their editorial policies.
What perplexed TrialSite was why these allegations didn’t come to life during the months of review by the editorial reviewers? Why at the very last minute? According to one well-placed source, part of the entire debacle was Fenter’s clash with one author, which led him to essentially “throw away the baby with the bath water.” Certainly, TrialSite can attest that when physicians and PhD researchers are involved, the ego is strong.
‘Extraordinary & Unprecedented Actions’
Offord shared with those interested in this topic the severity of the action directed by Fenter as again a whole edition dedicated to repurposed drugs targeting the COVID-19 epidemic, an incredibly important topic, was just eliminated overnight. In fact, The Scientist scribe shared that four of the five guest editors involved in this fiasco wrote a six-page resignation statement, declaring the journal’s actions “extraordinary and unprecedented.” These signatories included one of the top experts in federal funded drug-development focusing on vaccines and biotherapeutics in the United States, Robert Malone, and others, including the University of Urbino Carlo Bo’s Maria Cristina Albertini. TrialSite suggests that dissing authors of this prominence isn’t the sanest of things to do for the journal’s brand cachet.
Dynamic Markets Will Come
TrialSite’s in support of pharmaceutical efforts to develop prophylaxis and therapeutic options for COVID-19. Regeneron’s cocktail monoclonal antibody therapy under emergency use has evidenced promising results and the company is reviewing other means of administration.
Moreover, Merck’s effort to develop Molnupiravir, despite the company’s communications department’s unethical trouncing of their own ivermectin drug, is important—as is Pfizer and AstraZeneca’s AZD7442, originally developed at Vanderbilt. There are others as well as a number of generic drugs demonstrating material efficacious data, including fluvoxamine, Colchicine and more.
TrialSite’s position is that the world needs a dynamic, free market of branded and generic treatments for COVID-19. There is plenty of money to go around. But in what we call “Remdesivir Envy,” some pharmaceutical companies seek that same advantage and the associated position to secure billions quickly. Despite Gilead’s problems longer term with pipeline and stock price, they made brilliant moves and, from a business perspective, made master moves early on in the crisis.
But ultimately, the marketplace of the world, of course influenced by the laws, culture and mores of a particular national jurisdiction, will demand multiple therapies with multiple price points, from the high-end branded to cheap and easy for the poorest developing nations. That’s just the reality.
Be Objective—Get the Facts from Diverse Sources
TrialSite recommends that those interested in repurposed, generic approaches to addressing at least early onset, mild to moderate COVID-19 consider reading this important meta-analysis.
We argue that if you get your news only from CNN, MSNBC and Fox, not to mention Facebook that that news is tailored for “You” meaning its meant to actually keep you confused and even more perplexed, all while its purportedly hammering home the “truth.” Rather, look to multiple credible sources, speak with a range of different physicians and expert researchers, and importantly, use your own critical facility.
- Pierre Kory, MD, Front-Line Covid-19 Critical Care Alliance, Madison, WI
- Paul E Marik, MD, Eastern Virginia Medical School, Division of Pulmonary and Critical Care, Norfolk, VA
- Gianfranco Umberto Meduri, MD, Memphis VA Medical Center—University of Tennessee Health Science Center, Pulmonary, Critical Care, and Research Services, Memphis, TN
- Joseph Varon, MD, University of Texas Health Science Center, Critical Care Service, Houston, TX
- Jose Iglesias, DO, Department of Medicine, Hackensack School of Medicine, Seton Hall, NJ
Call to Action: Check out the publication here at the American Journal of Therapeutics.