Recently, France’s Capital became one of the first so-called “mainstream media” in Europe to breakdown the ivermectin situation in a somewhat objective manner. The prominent French publication not only drills into the potential of the drug used primarily throughout the low-to-middle income countries (LMICs) targeting parasites but also interviews an outspoken Dr. Gerard Maudrux who writes extensively on the potential for the drug as a low cost treatment for early onset mild COVID-19 cases. He and a number of other French physicians recommended at the Council of State that the national drug safety agency establish at least a provisional, emergency use evaluation. The ANSM committed with some response by the end of March. According to the French piece, although several countries have hosted ivermectin studies and even some Eastern European nations have authorized use on an emergency basis, Western health authorities, including the French medical establishment, have “snubbed” the emerging research. While many point to an economical agenda, another underlying factor is the political fallout that came from promotion of another repurposed drug from a controversial French doctor.
Originally developed to treat parasites in animals and certain viral diseases, a human version was authorized by 1988 to treat parasitic disease, such as scabies or onchocerciasis (river blindness) for over 30 years. With nearly 4 billion prescriptions on humans to date, according to World Health Organization (WHO) data, about 110-120 million people are treated per year. The safety profile at authorized doses for current indications is extremely safe. According to WHO data, the number of side effects since 1988 is 4,600 cases (compared to 180,000 for aspirin) for a rate of 0.0001 percent.
Off label for a COVID-19 indication is of course less certain but over 40 studies now targeting COVID-19 points to strong safety and efficacious signals. However, developed world health authorities indicate weakness in many of the dozens of studies. For a comprehensive list of studies, see the following link.
The French Nursing Home Incident
With the onset of the pandemic in France, Dr. Charlotte Bernigaud, a dermatologist from AP-HP Hospital Henri Mondor (Henri Mondor University Hospital), treated 121 people including 69 residents and 52 employees at a nursing home in Seine-et-Marne to treat an outbreak of scabies. What followed was nothing short of amazing. The average age of the resident was 90 at the time with 98% of the occupants presenting high-risk comorbidities. In any other such situation, the COVID-19 pathogen would have done significant harm with high mortality reports FraceSoir.
But here something else occurred. Only 1.4% of the occupants (including the staff) ended up infected by the novel coronavirus; and those infected only succumbed to moderate symptoms: for example, no residents needed oxygen support and there were no deaths.
Published as an Observational Study
Charlotte Beniguad and team wrote up the details of their observations in what is known as an observational study. The results were published in the British Journal of Dermatology in January 2021 and can be read here.
Noted was that 45 nursing homes in the Seine-et Marne, adjacent to Paris, evidenced far highty mortality rates—4.9% among 3,062 residents versus 0 in 121 in the nursing homes observed. Dr. Beniguad in collaboration with virologists from Henri Mondor Hospital also reproduced the University of Monash ivermectin in vitro study demonstrating the antiviral activity of the drug. This dermatologist of course doesn’t claim that the drug is a certified treatment nor that there is any particular efficacy—she cannot—but noted in the publication: “Despite limitations—observational nature and lack of correlation demonstrated in vitro /in vivo—the plausibility is sufficient to carry out randomized controlled trial in a cluster of prevention by ivermectin and MOX in EHPAD.”
The Ivermectin Discussion Worldwide
Of course, the dermatologists at Henri Mondor Hospital are not alone in asking the question whether ivermectin can help treat or even prevent COVID-19 infection, or at least limit the effects of the pathogen in humans. As acknowledged in this French article, the topic is discussed all over the world. TrialSite has been on the forefront in chronicling ivermectin-based studies.
Clinical trials from across the developing world (Bangladesh, Egypt, Iraq, Brazil, Colombia) and observational case series out of Broward County Florida to more recent ones in Europe (Spain) to the meta-analyses generated by groups or researchers, such as the Front Line COVID-19 Critical Care Alliance (FLCCC), Dr. Andrew Hill and Dr. Tess Lawrie, suggest the drug needs to be used in research immediately—others believe it should even be authorized for emergency use authorization.
While health authorities have truly either ignored or dismissed most of the dozens of studies primarily conducted in poor countries, even the U.S. National Institutes of Health (NIH) in the new year changed their COVID-19 recommendation from negative to neutral. Although, the U.S. FDA recently issued a cautionary statement to avoid being associated with COVID-19. One of the premier makers, Merck, declared the drug wasn’t necessarily safe nor effective but TrialSite suggested other reasons for the position.
Studies to Date
While about 40 or so studies have been conducted worldwide investigating the use of ivermectin in COVID-19 patients, only 20 of these studies are randomized. The vast majority of these studies conclude positive results—that it may actually serve as a prophylaxis and therapeutic support. Again, a decent summary of these reports can be reviewed here. TrialSite has been the leading online media worldwide chronicling ivermectin studies.
Not Enough for Health Authorities
But to most health authorities, these studies, mostly from what would be considered LMICs, are not sufficiently rigorous for any conclusions to be drawn. From size of samples, to dose administered to combination of drugs to the stage of the disease, the lack of purported uniformity and design rationalization leads to too much bias, for example.
The Colombian Study Gets Mass Media Attention
Then one particular study done in Colombia and published in the Journal of American Medical Association (JAMA) revealed that ivermectin wasn’t statistically effective. Although the overall ivermectin group showed positive data points, there wasn’t enough for statistical power. TrialSite’s OpEd feature included a number of academic-based articles challenging the findings of this particular study. TrialSite certainly noted the immediate interest in this study. CNN and the New York Times swooped in reporting ivermectin wasn’t effective. It all seemed strange, that is, the sudden interest. Also of note were the pharmaceutical payments at the very time the investigators were conducting this study. This isn’t evidence directly of any conflict of interest but certainly raised eyebrows.
Discussions in France
In France, Dr. Gérard Maudrux, interviewed recently in Capital, is a retired urological surgeon best known for having chaired the Autonomous Retirement Fund for Doctors of France for nearly two decades. While Dr. Maudrux is not an infectious disease specialist nor epidemiologist, he is certainly well known in at least some French medical circles. He noted that the major French research group INSERM conducts a number of COVID studies yet out of all the drugs involved, only one repurposed drug is involved. The drugs include remdesivir, lopinavir, lopinavir plus interferon combination). Other than some physicians seeing the data differently, the vast majority of establishment research and physicians discount the positive data associated with COVID-19 research.
Why not the EUA for Ivermectin?
Finally, Dr. Maudrux states, “the National Medicines Health Agency (ANSM) does not grant ivermectin, on the basis of the existing body of evidence, a temporary authorization for use (ATU) as it did recently for the monoclonal antibody investigational product from Eli Lilly.” These monoclonal antibody products, while showing some evidence of efficacy, are quite expensive ($1,200 pe dose in the USA), are complex to administer, etc.
Is this Hydroxychloroquine Blowback?
One prominent French doctor on condition of anonymity suggested that with the onset of the pandemic, drugs became politicized such as what occurred with the previous POTUS or with the French doctor Didier Raoult situation. That is that the powers-that-be do not want more controversy of the type associated with hydroxychloroquine, so they are well on the defensive.
Although WHO will update its interpretation of the Dr. Andrew Hill meta-analysis, given the pressures and societal strains mentioned above, increasingly many pro-ivermectin physicians and researchers are not upbeat about the prospects.
Call to Action: For the interview in Capital, follow the link.