Birth of a Myth: How Ivermectin Got Mixed Up With COVID-19

Dr. Carlos Chaccour, PhD

Dr. Carlos Chaccour, PhD, Assistant Research Professor, Barcelona Institute for Global Health, and Chief Scientific Officer of the Unitaid-funded BOHEMIA consortium project in Barcelona, Spain, is a scientist and researcher whose primary area of scientific interest is with Emerging Viruses, Malaria, and Coronavirus.

For the last 10 years, his most intense professional focus has been upon “the development of mosquito-killing drugs (endectocides) as complementary vector control strategy for malaria control and elimination.” In fact, the specific area in which he “obtained his PhD in 2015, was working with slow-release ivermectin formulations for that purpose.”

Dr. Joe Brew, PhD

In May 2020, he, along with fellow researchers  Dr. Joe Brew, PhD, a Data Scientist, Epidemiologist, and Economist; and Dr. Alberto García-Basteiro, MD, Assistant Research Professor at the Barcelona Institute for Global Health, ISGlobal in Barcelona, Spain, and physician at the International Health Service of Hospital Clínic, authored “Ivermectin and COVID-19: How a Flawed Database Shaped the Pandemic Response of Several Latin-American Countries.”

Dr. Alberto Garcia-Basteiro, MD

Their critical examination was in response to efforts by healthcare professionals and officials in the nations of Peru, Bolivia, Paraguay, and Colombia who suddenly began taking an unusual interest in ivermectin, and using it on COVID-19 patients in their respective nations. Those nations’ officials were motivated, in large part by a since-retracted, and debunked manuscript initially placed on a “preprint server,” a website which publishes online, a full draft of research which has not yet been validated by the peer-review process. The respected healthcare/medical science journal Lancet, which has been continually published since 1823 with the objective to improve people’s lives, states that “a preprint is a version of a scientific manuscript posted on a public server prior to any formal peer review.”

Specifically, Dr. Chaccour and colleagues examined antiviral research published June 2020 in Science Direct entitled “The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro,” i.e., in glass, such as test tube, beaker, or Petri dish, which was performed early in April by Australian researchers Leon Caly, Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, At the Peter Doherty Institute for Infection and Immunity, Victoria, Australia, Julian D. Druce, Senior Medical Scientist in the Virus Identification Laboratory of the Victorian Infectious Diseases Reference Laboratory, et al, which “used concentrations that are not readily achieved in the human body” but raised enough interesting questions that further investigation was warranted, and because of “the drug’s excellent safety profile and lack of effective treatment for COVID-19.”

In response to their critical examination, and genuine questions about the techniques and methods, they wrote a guest editorial entitled “Ivermectin and COVID-19: Keeping Rigor in Times of Urgency” which was published in Volume 102, issue 6 of the American Journal of Tropical Medicine and Hygiene in which they wrote in part that, “Caly et al.¹⁰ recently reported that ivermectin is a potent inhibitor of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in vitro. Given the coronavirus disease-19 (COVID-19) pandemic, this has understandably resonated widely in the global press,¹¹” and called for “scientific rigor and provide rationale for conducting trials.”

Dr. Chaccour and his colleagues immediately began their own investigation to determine ivermectin’s efficacy in treatment of COVID-19 on May 13, and code-named their investigation “SAINT” — SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) — which was a Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission.

It was with that intense level of scrutiny, and grave concern for others, that Dr. Chaccour and his team noted that “policy decisions in Latin-American have been largely based on the analysis presented in a pre-print posted in the SSRN repository in early April by Patel et al.”

The SSRN online repository is a “preprint server,” referring to research which has not yet been scrutinized by the peer review process before being officially published (printed) in scientific journals.

The analysis to which Dr. Chaccour referred HAS SINCE BEEN RETRACTED, first appeared online on the SSRN website April 6, was entitled “Ivermectin in COVID-19 Related Critical Illness” and authored by:

• Amit N. Patel MD MS, University of Utah, Salt Lake City, UT – Principal Investigator
• Sapan S. Desai MD PhD MBA, Surgisphere Corporation, Chicago, IL
• David W. Grainger PhD, University of Utah, Salt Lake City, UT
• Mandeep R. Mehra, MD, MSc, Brigham and Women’s Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA

Dr. Chaccour and his team of researchers found numerous problems with the SSRN-published manuscript by Patel, et al, including violations of “EU General Data Protection Regulation (GDPR) and the Privacy Shield EU-US” and noted that others had also raised similar concerns about the pre-print work which also included a manuscript entitled “Hydroxychloroquine analysis published in The Lancet by the same authors of the ivermectin pre-print.”

Most grossly notable in the SSRN submission was the fact that claims by the authors were made that were obviously and demonstrably false, such as claiming that they conducted “an observational registry-based study from 169 hospitals across Asia (AS), Europe (EU), Africa (AF), North (NA) and South America (SA), [in which] we evaluated critically ill hospitalized patients diagnosed with COVID-19 with lung injury requiring mechanical ventilation, between January 1st 2020 and March 1st 2020.”

However, the most glaring problem with that manuscript, which Dr. Chaccour noted, was that

“by March 1st, only two COVID-19 cases had been confirmed in the whole African continent.”

After Dr. Chaccour and his team found “out this discrepancy, [they] contacted the authors via email and the answers [we] received left our concerns unchanged.” He wrote further that, “additionally, the manuscript presented a survival analysis with serious methodological flaws.”

A survival analysis, sometimes also called a “Cox Model,” is a statistical tool used in research which was developed by renown British statistician Sir David Cox who was also named the 2016 inaugural recipient of the International Prize in Statistics for his work in developing a Survival Analysis Model which is often applied in Medicine, Science, and Engineering. Using the mathematical tool and formula he developed, proved, and presented in a 1972 paper, researchers can accurately estimate, and “more easily identify the risks of specific factors for mortality or other survival outcomes among groups of patients with disparate characteristics. From disease risk assessment and treatment evaluation to product liability, school dropout, reincarceration and AIDS surveillance systems, the Cox Model has been applied essentially in all fields of science, as well as in engineering.”

After that problem was found, the pre-print’s authors withdrew their initial paper, and replaced it with a second version on April 19… which also had problems. And in that version, it was the statement that the 704 (half) of the subjects of the research were matched “exactly on age, sex, race, underlying co-morbidity including chronic obstructive pulmonary disease (COPD), history of smoking, history of hypertension, diabetes mellitus, coronary artery disease, other cardiac disease, an index of illness severity (qSOFA) as well as medication use including hydroxychloroquine, azithromycin and corticosteroids.”

Such a claim is, on its face, preposterously and patently absurd — to find 704 people who were matched “exactly” on 14 separate, though variable, points.

From there, Dr. Chaccour and his team found other problems in the pre-print paper, which also included his critical observation that “The need for mechanical ventilation in untreated patients seems quite high,” and that “The data described in the manuscript do not match the figure” presented in their work.

And in response to those problematic findings, he wrote that,

“In spite of these flaws this analysis has been cited in a white paper advocating for ivermectin to be included in the national COVID-19 treatment guidelines of Peru. This was followed shortly by a ministerial level communication recommending the use of ivermectin for COVID-19, albeit recognizing the lack of evidence and requesting informed consent. This however led to a black market and alleged distribution of veterinary formulations. All in spite of some strong voices from local scientific leaders including the ex-minister of Health Patricia García.”

Subsequently, Dr. Chaccour noted with distress that, in response to the false claims made in the pre-print manuscript, Bolivian health officials “followed closely and even went a step further into distributing 350,000 ivermectin doses in the city of Trinidad,” and that authorities in Paraguay “had to restrict ivermectin sales after a surge in demand.”

From there, he continued to cite several other problems with that work, which effectively rendered it null and void – scientifically invalid, and therefore utterly useless. In essence, the pre-print manuscript was discovered to be nothing but a pseudo-scientific fairy tale… albeit one which has created problems far beyond those South American nations.

He concluded by writing, “scientific rigor is needed, even in pandemic times.”

The process of the scientific method has 5 parts:

1. State the problem.
2. Form a hypothesis.
3. Observe and experiment.
4. Interpret data.
5. Draw conclusions.

Part of the beauty of science, and research, is that it’s like a recipe — use the same ingredients and volumes, follow the directions, and you’ll come up with the same results.

For scientists and researchers, it means that, if others, using the same tools and techniques, and performing the same research in the same way, ought to come up with the same results. There are also ways to investigate the process – which is also why the process is mentioned in most scientific papers – that by “checking the ingredients list,” or the steps and processes employed, to determine if an error, or mistake, may have been made.

So, for example, if you found a recipe for chocolate cake and it stated to use 1 cup of salt, you’d be dumbstruck because of the excessive volume used, simply because you (hopefully) know better by experience, that any resulting “cake” would be utterly horrible, and inedible.

In a similar manner as one might read a recipe, Dr. Chaccour and his team analyzed the paper and found that it had more holes than a block of Swiss cheese.

So from that point, it was but a mere hop, skip, and a jump for the 24/7 global media, and others, to pick up that deflated ball, and run with it.

Some of the ones who did include:

• Children’s Health Defense, an anti-vaccine group founded by Robert F. Kennedy, Jr.
• Preston Smiles, a “Life Coach” with 225,000 Instagram followers
• Sidney Powell, former Federal prosecutor and QAnon conspiracy theorist with 129,700 Telegram followers
• Joe Rogan, a Comedian with 13.1 million Instagram followers

And then, there are the “usual suspects” — Fox News hosts Tucker Carlson, Sean Hannity, and Laura Ingraham who have all praised the debunked work, and its bogus so-called “treatment,” including the recently-deceased Nashville, TN-based conservative talk radio host Phil Valentine, who died of COVID-19. Interestingly, they all “seem to have pivoted from hydroxychloroquine to ivermectin without missing a beat.”

Then, there are Congressional sympathizers, including, most notably, Republican Kentucky Senator Dr. Rand Paul, MD who purports to be an ophthalmologist, and as a physician, ought to know better. But the bitter irony of hypocrisy is that, even though Senator Paul blames “Trump Derangement Syndrome” and his political opponents as culprit, it was he who VOTED AGAINST the pandemic stimulus bill in March that included funding for the NIH ACTIV-6 trial, which is studying ivermectin, and “testing several medications that are already approved for other diseases to see if they can help people with mild to moderate COVID-19 feel better faster and stay out of the hospital.” Go figure.

When Dr. Chacour reported the results of his “SAINT” research trial — a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease — he and his team found that ivermectin was NOT EFFECTIVE against COVID-19. And simply for sharing the truth of those valid scientific, peer-reviewed findings, he received volumes of hate mail. So did his wife. So did University of Minnesota physician and infectious disease researcher Dr. David Boulware, MD, Professor of Medicine, Division of Infectious Diseases and International Medicine, who is an infectious disease physician-scientist with formal training in clinical trials, public health, and tropical medicine.

How bizarre is it to hold such a strong belief in the efficacy of ivermectin to treat COVID-19, that anyone would think it be unethical to withhold it… and then, to do so in the context of a scientific trial designed precisely to determine clinical effectiveness?

And yet, that’s what some are doing.

The hypocrisy is blinding.

Perhaps the real question that ought to be asked is, “who sold those folks that bad bill of goods – so that they would believe a lie – in the first place”?

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Adapted from “The Real Reason People Are Treating Themselves With Horse Dewormer — The ivermectin feed store memes are grossly classist. They’re also missing the point.,” by Kiera Butler, Senior Editor, Mother Jones, September 1, 2021

The Real Reason People Are Treating Themselves With Horse Dewormer