Excerpts from the article.

by The Front Line COVID-19 Critical Care Alliance

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.”

A health system structured to function in this manner is clearly vulnerable to and overly influenced by entities with financial interests. Further, in Covid, such systems have evolved into rigidly operating via top-down edicts and widespread censoring. This allows little ability for emerging scientific developments not funded by Big Pharma to be disseminated from within the system or through media or social media until years later when, and if, a Big RCT is completed. This barrier has presented as an enduring horror throughout the pandemic given the widespread loss of life caused by the systematic withholding of numerous rapidly identified, safe and effective, repurposed medicines for fear of using “unproven therapies” without “sufficient evidence” for use. Alternatively, and for the first time in many physicians’ careers, those who seek to treat their patients with such therapies, based on their professional interpretation of the existing evidence are restricted by their employers issuing edicts “from above.” They are then forced to follow protocols that rely predominantly on pharmaceutically engineered therapeutics.

It must be recognized that distinct from “regulatory” agencies such as the FDA, whose system often relies upon the primary importance of a “Big RCT,” stronger foundations used by PHAs are available. One of the long-standing tenets of modern evidence-based medicine is that the highest form of medical evidence is a “systematic review and meta-analysis” of RCTs and not a sole Big RCT. Disturbingly, not one of the Big PHAs mention this established principle or their long-standing reliance on such evidence-based practices for issuing recommendations. In the case of ivermectin, they willfully ignore the multiple published expert meta-analyses of ivermectin RCTs, including almost two dozen trials and thousands of patients, reporting consistent reductions in mortality, time to clinical recovery, and time to viral clearance.

These improvements are found consistently and repeatedly, no matter the RCT design, size, or quality, and from varied centers and countries throughout the world. All studies were done without any identified conflict of interest with the vast majority of double-blind, single-blind, quasi-randomized, open-label, standard of care comparison, combination therapy comparisons, etc., reporting benefits. Satoshi Omura, Nobel Prize-winning discoverer of ivermectin, wrote in his team’s recent review paper that “the probability of this judgement on ivermectin’s superior clinical performance being false is estimated to be 1 in 4 trillion.” This supports our public warnings against further “placebo-controlled trials” given the near absolute certainty of harm to research subjects included in a placebo Big RCT.

Conversely, despite sitting atop the highest form of medical evidence, many non-regulatory Big PHAs around the world cry out for a Big RCT. This is while avoiding the issuance of even one of the several “weaker” recommendation options available to them in the setting of a low-cost, widely available medicine with an unparalleled safety profile and a constantly surging humanitarian crisis, even in the interim. Insufficient evidence, unproven — these are comments from WHO, NIH, Europe’s EMA, South Africa’s SAPHRA, France’s ANSM, United Kingdom’s MHRA, and Australia’s TGA.

Most disturbing to contemplate is our estimation that if the use of penicillin in bacterial infection were to have been tested in these same numbers and types of trials in the 1940s, the graphical display of benefits would look nearly identical to those found with ivermectin. Further, the U.S Cures Act of 2016, “specifically designed to accelerate and bring new innovations and advances faster and more efficiently to the patients who need them” emphasized the importance of using various forms of “real-world evidence” data to aid in regulatory decision-making. We can find no evidence of an organized effort to examine the more than 14, often large OCTs that show evidence of the substantial beneficial use of ivermectin. Further, no PHA has cited the numerous convincing epidemiological analyses that find rapidly falling case fatality rates following ivermectin distribution campaigns.

With the lack of a credible explanation for the absence of even a weak recommendation for ivermectin in the setting of widespread increased death rates from COVID-19, numerous citizens have speculated that this can only be explained by the presence of an active disinformation campaign by entities with nonscientific and largely financial objectives dependant on the non-recognition of ivermectin’s efficacy. We explore the near certainty of this occurring below.

Active Political-Economic “Disinformation” Campaign

“Disinformation” campaigns, best described in the article, “The Disinformation Playbook,” are initiated when independent science interferes with or opposes the interests of corporations or policymakers. Although thankfully rare, in certain cases these entities will actively seek to manipulate science and distort the truth about scientific findings that imperil their profit or policy objectives. First developed by the tobacco industry decades ago, these deceptive tactics include the following; 

• The Fake: Conduct counterfeit science and try to pass it off as legitimate research.
• The Blitz: Harass scientists speaking out with results inconvenient for industry.
• The Diversion: Manufacture uncertainty about science where little or none exists. 
• The Screen: Buy credibility through alliances with academia/professional societies.  
• The Fix: Manipulate government processes to influence policy inappropriately.

Numerous examples of the above disinformation tactics by corporations and policymakers, particularly within the pharmaceutical industry, have been documented: 

• Georgia Pacific publishing “fake science” on the dangers of asbestos (The Fake)
• Merck manipulating the science around the drug Vioxx (The Fake)
• The NFL intimidating and discrediting scientists reporting link between football and Traumatic Brain Injury (The Blitz)
• GlaxoSmithKline silencing scientists exposing the dangers of Avandia (The Blitz)
• American Chemistry Council sows uncertainty about formaldehyde risks (The Diversion)
• Purdue Pharma partners with academic centers to hide dangers of opioids (The Screen)
• Pfizer pressures FDA to downplay risk of animal drug causing high arsenic (The Fix)

Most worrisome is that ivermectin appears to be up against one of the largest financial and global policy oppositions in modern history, including but not limited to:

• Numerous Big Pharma companies and sovereign nations selling billions of vaccine doses. 
  • Scale of market for vaccines now exponentially increasing due to the developing market for “booster shots” against rapidly appearing variants. 
  • Big Pharma now promising investors to employ price hikes on vaccines as COVID-19 passes from a “pandemic” to an “endemic.”
• Concerns of numerous Big Pharma and Big PHA’s that if ivermectin is approved as effective treatment for COVID-19, EUAs for all vaccines would be revoked.
  • Disinformation: FDA posted notices overstating the dangers of ivermectin and against use of ivermectin; despite not having reviewed the trials data.
  • Disinformation: WHO Panel dismisses/ignores most of available evidence base.
  • Disinformation: WHO Panel avoids bringing ivermectin evidence to a vote.
  • Disinformation: Unitaid sponsor influences writing of manuscript conclusions.
  • Disinformation: EMA erroneously claims effective concentrations are unattainable.
• Numerous Big Pharma/Big PHA concerns that ivermectin’s potential as an alternative to vaccines may increase vaccine hesitancy and disrupt mass vaccination rollouts. 
  • Opponents include large philanthropic sponsors with global vaccination goals.
  • Disinformation: WHO Panel does not review ivermectin prevention trials.
• Numerous Big Pharma company investments in novel, engineered therapies (i.e., oral antivirals by Merck and Pfizer and Gilead) directly compete with ivermectin.
  • Disinformation: Merck places a post on their website, without scientific supporting evidence or named scientist authors that: “No evidence of either a mechanism of action, clinical efficacy or safety in COVID-19 exists.”
  • Disinformation: A Merck managing director argues against use in the Philippines by stating: “The levels of evidence do not come up to standards.”  
• Big Pharma company’s (Astra-Zeneca) investment into a long-acting antibody product for prevention and treatment of COVID-19, which competes with ivermectin.
• Numerous Big Pharma’s monoclonal antibody products that compete with ivermectin.
• Big Pharma’s Remdesivir demand would rapidly decline once hospitalizations were to decrease after ivermectin approval.

Based on the lack of a rational explanation for the above actions by WHO, Merck, FDA, and Unitaid, we conclude that they result from an active disinformation campaign, executed both through the PHA’s, media and the WHO Guideline group recommendations. As highly published researchers, we find the allegations of scientific misconduct in the writing of the WHO/United research team’s meta-analysis manuscript to be deeply disturbing. It clearly represents a disinformation tactic with an intent to distort and diminish the reporting of a large magnitude benefit on mortality among many hundreds of patients. Further, Merck’s demonstrably and blatantly false statements against ivermectin deserve  no further discussion. It is yet another entry into the disturbing historical record of actions committed by a Big Pharma entity with the primary intent of protecting profit at the expense of the welfare of global citizens.

For These Compelling and Irrefutable Reasons, The FLCCC Makes a Call to Action 

This call to action is no longer just to health authorities, but to citizens everywhere to fight back against these disinformation tactics. We find the advice of the Union of Concerned Scientists (UCS) to be an excellent guide to action in this regard: 

Global Citizens

1. Share the playbook with your social media networks when you see new examples like those outlined above.
2. Set the record straight. When you see someone spreading disinformation on a topic, counter it. There are millions around the world who either have studied the data or have experience with the potent efficacy of ivermectin in COVID-19. It is important to  correct false assertions.
3. Consider divesting your retirement funds and other investments from companies engaging in disinformation.

Fellow Scientists

1. Become a UCS Network Watchdog to help track and resist attacks on science.
2. If a governmental or NGO scientist, report actions that diminish their role in policymaking.

Media

1. Avoid false equivalencies that distort scientific consensus.
2. Correct the record when scientific information is misrepresented, particularly by Big PHA/Big Pharma.
3. Report abuses of science in government. 

As an expert group of ivermectin researchers, we are unsure of what else to offer in order to correct or counteract this misrepresentation of an important drug. Our belief is that, of the above actions, the most effective counter to the disinformation campaign would be that a whistleblower become active from within WHO, the FDA, the NIH, Merck, or Unitaid. This moment in history demands a man or woman with the courage and conviction to step forward. Urgently.

In both the interests of humanity and to motivate and inspire such a citizen of the world, we leave you with the words of Albert Einstein: “The world will not be destroyed by those who do evil, but by those who watch them and do nothing.”

[1]Special emphasis must be placed on this decision; selecting only trials where very few deaths occurred.
(n.b., the number of events observed within trials is a primary criterion for judging the “certainty of evidence”). This action provides almost the entire basis for the panel’s assessment of a “very low certainty of evidence.” It is in effect, a “smoking gun,” one of the many actions above demonstrating that the primary objective of the Panel was to recommend against use of ivermectin.
[2]This omission is the second most important action allowing the panel to find a “very low certainty of evidence,” given that, per WHO protocol, if a dose-response relationship is found, the certainty of evidence must be upgraded.
[3]Special emphasis must be placed on the harm of excluding trials data supporting ivermectin in the prevention of COVID-19. If the preventive efficacy of ivermectin were to be known or accepted, this would allow deployment in regions without vaccines.
[4]British Ivermectin Recommendation Development (BIRD) panel (2021). The BIRD Recommendation on the Use of Ivermectin for COVID-19. Full report. https://tinyurl.com/u27ea3y
[5]The FLCCC Alliance recommended, as well as gave U.S. Senate testimony in support of, the use of corticosteroids in COVID-19 months before this announcement, during the prolonged period when all PHAs recommended against its use

Sincerely, 

The Front Line COVID-19 Critical Care Alliance

Pierre Kory, MD
Keith Berkowitz, MD
Paul E. Marik, MD
Fred Wagshul, MD
Umberto Meduri, MD
Scott Mitchell, MBChB
Joseph Varon, MD
Eivind Vinjevoll, MD
Jose Iglesias, DO

Full Article: 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