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:
- 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.).
- 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:
- No pre-established protocol for data exclusion was published, which is a clear departure from standard practice in guideline development.
- 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
- The WHO excluded all “quasi-randomized” RCTs from consideration (two excluded trials with over 200 patients that reported reductions in mortality).
- 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.
- 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
- WHO Review: Excluded multiple RCTs such that only 31 total trials deaths occurred; despite this artificially meager sample, a 91% reduction in the risk of death was found.
- 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
- WHO Review: 6 RCTs, 625 patients. The Panel avoided mention of the important finding of a strong dose-response in regard to this outcome.
- 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.
- Adverse Effects
- 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.
- 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:
- “Over one billion doses have been given in large-scale prevention programs.”
- “Adverse events associated with ivermectin treatment. are primarily minor and transient.”
- 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.
- 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.
- One large, propensity-matched OCT from the US found that ivermectin treatment was associated with a large decrease in mortality.
- 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:
- 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.
- 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:
- An international expert guideline group independently reviewed the BIRD proceeding and instead found the overall quality of trials to be “moderate.”
- The WHO’s own Unitaid systematic review team currently grade the overall quality as “moderate.”
- 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.
Read the rest: https://covid19criticalcare.com/videos-and-press/flccc-releases/flccc-alliance-statement-on-the-irregular-actions-of-public-health-agencies-and-the-widespread-disinformation-campaign-against-ivermectin/