FLCCC Alliance Statement on the Ivermectin Disinformation Campaign

Written by covid19criticalcare.com on May 27, 2021. Posted in Current News

Image: MedPage Today

Awareness of ivermectin’s efficacy and its adoption by physicians worldwide to successfully treat COVID-19 have grown exponentially over the past several months. Oddly, however, even as the clinical trials data and successful ivermectin treatment experiences continue to mount, so too have the criticisms and outright recommendations against the use of ivermectin by the vast majority, though not all, of public health agencies (PHA), concentrated largely in North America and Europe.

The Front Line COVID-19 Critical Care Alliance (FLCCC) and other ivermectin researchers have repeatedly offered expert analyses to respectfully correct and rebut the PHA recommendations, based on our deep study and rapidly accumulated expertise “in the field” on the use of ivermectin to treat COVID-19.

These rebuttals were publicized and provided to international media for the education of providers and patients across the world. Our most recent response to the European Medicines Agency (EMA) and others recommendation against use can be found on the FLCCC website here.

In February 2021, the British Ivermectin Recommendation Development (BIRD), an international meeting of physicians, researchers, specialists, and patients, followed a guideline development process consistent with the WHO standard. It reached a consensus recommendation that ivermectin, a verifiably safe and widely available oral medicine, be immediately deployed early and globally.

The BIRD group’s recommendation rested in part on numerous, well-documented studies reporting that ivermectin use reduces the risk of contracting COVID-19 by over 90% and mortality by 68% to 91%.

A similar conclusion has also been reached by an increasing number of expert groups from the United Kingdom (UK), Italy, Spain, United States (US), and a group from Japan headed by the Nobel Prize-winning discoverer of Ivermectin, Professor Satoshi Omura. Focused rebuttals that are backed by voluminous research and data have been shared with PHAs over the past months. These include the WHO and many individual members of its guideline development group (GDG), the FDA, and the NIH.

However, these PHAs continue to ignore or disingenuously manipulate the data to reach unsupportable recommendations against ivermectin treatment. We are forced to publicly expose what we believe can only be described as a “disinformation” campaign astonishingly waged with full cooperation of those authorities whose mission is to maintain the integrity of scientific research and protect public health.

The following accounting and analysis of the WHO ivermectin panel’s highly irregular and inexplicable analysis of the ivermectin evidence supports but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against ivermectin. This is despite the overwhelming evidence by respected experts calling for its immediate use to stem the pandemic. Additionally, there appears to be a wider effort to employ what are commonly described as “disinformation tactics” in an attempt to counter or suppress any criticism of the irregular activity of the WHO panel.

The WHO Ivermectin Guideline Conflicts with the NIH Recommendation

The FLCCC Alliance is a nonprofit, humanitarian organization made up of renowned, highly published, world-expert clinician-researchers whose sole mission over the past year has been to develop and disseminate the most effective treatment protocols for COVID-19. In the past six months, much of this effort has been centered on disseminating knowledge of our identification of significant randomized, observational, and epidemiologic studies consistently demonstrating the powerful efficacy of ivermectin in the prevention and treatment of COVID-19.

Our manuscript detailing the depth and breadth of this evidence passed a rigorous peer review by senior scientists at the U.S Food and Drug Administration and Defense Threat Reduction Agency. Recently published, our study concludes that, based on the totality of the evidence of efficacy and safety, ivermectin should be immediately deployed to prevent and treat COVID-19 worldwide.

The first “red flag” is the conflict between the March 31, 2021, WHO Ivermectin Panel’s “against” recommendation and the NIH’s earlier recommendation from February 12th of a more supportive neutral recommendation based on a lower amount of supportive evidence of ivermectin’s efficacy at that time.

Two flawed lines of analysis by the WHO appear to account for this inconsistent result:

1. The WHO arbitrarily and severely limited the extent and diversity of study designs considered (e.g., retrospective observational controlled trials (OCT), prospective OCTs, epidemiological, quasi-randomized, randomized, placebo-controlled, etc.).
2. The WHO mischaracterized the overall quality of the trial data to undermine the included studies.

The Severely Limited Extent and Diversity of Ivermectin Data Considered by the WHO’s Ivermectin Panel

The WHO Ivermectin Panel arbitrarily included only a narrow selection of the available medical studies that their research team had been instructed to collect when formulating their recommendation, with virtually no explanation why they excluded such a voluminous amount of supportive medical evidence. This was made obvious at the outset due to the following:

1. No pre-established protocol for data exclusion was published, which is a clear departure from standard practice in guideline development.
2. The exclusions departed from the WHO’s own original search protocol it required of Unitaid’s ivermectin research, which collected a much wider array of randomized controlled trials (RCT).

Key Ivermectin Trial Data Excluded from Analysis

1. The WHO excluded all “quasi-randomized” RCTs from consideration (two excluded trials with over 200 patients that reported reductions in mortality).
2. The WHO excluded all RCTs where ivermectin was compared to or given with other medications. Two such trials with over 750 patients reported reductions in mortality.
3. The WHO excluded from consideration 7 of the 23 available ivermectin RCT results.  Such irregularities skewed the proper assessment of important outcomes in at least the following ways:

Mortality Assessment

1. WHO Review: Excluded multiple RCTs such that only 31 total trials deaths occurred; despite this artificially meager sample, an estimate of up to a 91% reduction in the risk of death was found.[1]
2. Compared to the BIRD Review: Included 13 RCTs with 107 deaths observed and found a 2.5% mortality with ivermectin vs. 8.9% in controls; estimated reduction in risk of death=68%; highly statistically significant, (p=.007).

Assessment of Impacts on Viral Clearance

1. WHO Review: 6 RCTs, 625 patients. The Panel avoided mention of the important finding of a strong dose-response in regard to this outcome.
2. This action in (i) is indefensible given that their Unitaid research team found that among 13 RCTs, 10 of the 13 reported statistically significant reductions in time to viral clearance, with larger reductions with multiday dosing than single-day, consistent with a profound dose-response relationship.[2]

Adverse Effects

1. WHO: Only included 3 RCTs studying this outcome. Although no statistical significance was found, the slight imbalance in this limited sample allowed the panel to repeatedly document concerns for “harm” with ivermectin treatment.
2. Compare (a) to the WHO’s prior safety analysis in their 2018 Application for Inclusion of Ivermectin onto Essential Medicines List for Indication of Scabies:
   1. “Over one billion doses have been given in large-scale prevention programs.”
   2. “Adverse events associated with ivermectin treatment. are primarily minor and transient.”[3]

The WHO excluded all RCTs studying the prevention of COVID-19 with ivermectin, without supporting rationale. Three RCTs including almost 800 patients found an over 90% reduction in the risk of infection when ivermectin is taken preventively.[4]

The WHO excluded observational controlled trials (OCT), with 14 studies of ivermectin. These included thousands of patients, including those employing propensity matching, a technique shown to lead to similar accuracy as RCTs.

1. One large, propensity-matched OCT from the US found that ivermectin treatment was associated with a large decrease in mortality.
2. A summary analysis of the combined data from the 14 available ivermectin OCTs found a large and statistically significant decrease in mortality.

The WHO excluded numerous published and posted epidemiologic studies, despite requesting and receiving a presentation of the results from one leading epidemiologic research team. These studies found:

1. 1. In numerous cities and regions with population-wide ivermectin distribution campaigns, large decreases in both excess deaths and COVID-19 case fatality rates were measured immediately following the campaigns.
   2. Countries with pre-existing ivermectin prophylaxis campaigns against parasites demonstrate significantly lower COVID-19 case counts and deaths compared to neighboring countries without such campaigns.

Assessment of the Quality of the Evidence Base by WHO Guideline Group

The numerous above actions minimizing the extent of the evidence base were then compounded by the below efforts to minimize the quality of the evidence base:

The WHO mischaracterized the overall quality of the included trials as “low” to “very low,” conflicting with numerous independent expert research group findings:

1. An international expert guideline group independently reviewed the BIRD proceeding and instead found the overall quality of trials to be “moderate.”
2. The WHO’s own Unitaid systematic review team currently grade the overall quality as “moderate.”
3. The WHO graded the largest trial it included to support a negative assessment of ivermectin’s mortality impacts as “low risk of bias.” A large number of expert reviewers have graded that same trial as “high risk of bias,” detailed in an open letter  signed by over 100 independent physicians.

We must emphasize this critical fact: If the WHO had more accurately assessed the quality of evidence as “moderate certainty,” consistent with the multiple independent research teams above, ivermectin would instead become the standard of care worldwide, similar to what occurred after the dexamethasone evidence finding decreased mortality was graded as moderate quality, which then led to its immediate global adoption in the treatment of moderate to severe COVID-19 in July of 2020.[5]

Further, The WHO’s own guideline protocol stipulates that quality assessments should be upgraded when there is the following:

1. a large magnitude of effect (despite their data estimating a survival benefit of 81%, the low number of studies and events included allowed them to dismiss this finding as “very low certainty”) or;
2. evidence of a dose-response relationship. The WHO shockingly omits the well-publicized reports by their Unitaid research team of a powerful dose-response relationship with viral clearance.

In sum, the WHO’s recommendation that “ivermectin not be used outside clinical trials” is based entirely upon:

1. the dismissal of large amounts of trial data;
2. the inaccurate downgrading of evidence quality; and
3. the deliberate omission of a dose-response relationship with viral clearance.

Consequently, these actions formed the basis of their ability to avoid a recommendation for immediate global use.

Even more surprising is that based on their “very low certainty” finding, the panel goes on to “infer” that “most patients would be reluctant to use a medication for which the evidence left high uncertainty regarding effects on outcomes they consider important.”

This statement is insupportable in light of the above actions. No patient could ever rationally consent to a trial in which they were acutely ill and would be subject to the possibility of receiving a placebo, once informed of: the large amount of relevant and positive trials that the WHO removed from consideration, their avoidance of reporting a large dose-response relationship, and their widely contradicted “very low certainty” grading of large mortality benefits. Such a trial would result in a historic ethical research violation, causing both a widespread loss of life and a resultant loss of trust in PHAs and research institutions for decades to come.

The many methods employed by the WHO to distort the evidence base and arrive at a non-recommendation are made even more suspicious and questionable by the following:

1. The WHO GDG did not hold a vote on the use of ivermectin. This highly irregular decision was purportedly based on the Ivermectin Panel’s “consensus on evidence certainty.”
2. Unitaid Sponsors allegedly inserted multiple limitations and weakened the conclusions in the preprint, systematic review manuscript by the Unitaid research team, which has recently led to formal charges of scientific misconduct.
3. Recent WHO whistleblower complaints of external influences in other WHO Covid reports, as well as attempts by massive external funding organizations to increase their influence in formulating WHO policies.
4. The finding of marked differences in the evidence bases used to support prior WHO/BIRD guideline recommendations for ivermectin in other diseases:

1. 1. WHO: Approved ivermectin in the treatment of scabies based on 10 RCTs that included only 852 patients, despite it being inferior to the standard of care.
   2. FDA: Approved ivermectin in the treatment of strongyloidiasis based on 5 RCTs that included only 591 patients.
   3. BIRD: Approved ivermectin in March, 2021, for the prevention and treatment of COVID-19 based on 21 RCTs and 2,741 patients.

Conclusion

As expert clinician-researchers in society, we are firmly committed to ensuring that public health policy decisions derive from scientific data.  Disturbingly, after extensive analysis of the recent WHO ivermectin guideline recommendation, we could not arrive at a credible scientific rationale to explain the numerous irregular, arbitrary, and inconsistent behaviors documented above. Further, after consultation with numerous physicians, guideline reviewers, legal experts, and veteran PHA scientists, we identified two major socio-political-economic forces that serve as the main barrier influences preventing ivermectin’s incorporation into public health policy in major parts of the world. They are:

1)  the modern structure and function of what we will describe as “Big Science” and;

2)  the presence of an active “Political-Economic Disinformation Campaign.”

“Big Science”

Also known as “Big RCT Fundamentalism,” Big Science reflects a dramatic shift in the practice of modern evidence-based medicine (EBM). Beginning before COVID, it has since rapidly evolved into the current system that more tightly meshes the entities of “Big Pharma,” “Big PHA’s/Academic Health Centers” (AMC), “Big Journals,” “Big Media,” and “Big Social Media” into the public health system’s efforts at guiding patient care, research and policy.

The structure and function of “Big Science” in COVID-19 is most simply represented as follows:

• Only arbitrarily defined, “large, well-designed” RCTs (Big RCT), generally conducted on North American or European shores, can “prove” the efficacy of a medicine.
• Only Big Pharma/Big PHA/AMCs have the resources/infrastructure to conduct Big-RCTs. (Many equate Big PHA/AMC with Big Pharma, given the funding source of the former.)
• Only Big RCTs by Big Pharma or Big PHA/AMC can publish study findings in high-impact, high-income country medical journals (Big Journals).
• Only medicines supported by Big Journal publications are deemed to have “sufficient evidence” and “proven efficacy” to then be recommended by Big PHAs.
• Only medicines recommended by Big PHAs are covered by “Big Media” or escape censorship on “Big Social Media.”

Conversely, repurposed, off-patient medications such as ivermectin do not attract Big PHA or Big Pharma sponsors to conduct the mandatory Big RCT. Given this structural handicap, many effective medicines including ivermectin are consequently incapable of ever meeting Big PHA standards for approval in such a system. In the case of ivermectin, it is then considered, first by Big PHAs, then throughout Big Media and Big Social media, to be “unproven” given it lacks “sufficient evidence” and is thus heavily censored from public discussion and awareness.

Mentions of ivermectin on Big Social Media led to the removal of a popular Facebook group (“Ivermectin MD Team” with over 10,000 followers). Additionally, all YouTube videos mentioning ivermectin in treatment of Covid-19 were removed or demonetized, as well as Twitter pages locked. Further, in Big Media, even the most credentialed independent and expert groups who recommend ivermectin based on a large body of irrefutable evidence are labeled as “controversial” and purveyors of “medical misinformation.”

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