
Witness Testimony
Keywords from Transcript
Ivermectin Repurposing, Merck Employment Background, FDA Emergency Use Authorization, Off-Label Promotion Restrictions, TOGETHER Trial Critique, Statistical Significance Misuse, Meta-Analysis Mortality Reduction, Early Treatment Benefit, 95 Clinical Trials Pooled, Safety Profile Four Billion Doses, Paxlovid Safety Comparison, Molnupiravir DNA Risk Claim, NIH Research Funding Proposal, Patent Incentive Structure, Regulatory Agency Accountability
Included in the Report:
Mr. Charles Hooper
Pharmaceutical Industry Consultant
Expert
Witness ID:
NCI-W-101
Hearing
Winnipeg
Manitoba
Date:
April 14, 2023
Report
Inquiry into the Appropriateness and Efficacy of the COVID-19 Response in Canada; November 2023
Main Topic
Testimony asserting that ivermectin was a safe and effective repurposed COVID treatment that was improperly discredited by regulatory agencies due to structural incentives, statistical misinterpretation, and off-patent market dynamics.
One Line Summary
Pharmaceutical consultant Charles Hooper testified that ivermectin’s safety and efficacy were misrepresented during COVID due to regulatory incentives, flawed statistical interpretation, and lack of financial incentive for off-patent drugs.
Synopsis
Charles Hooper testified that during pandemics, repurposed medications with established safety profiles should be prioritized because new drug development is too slow to respond to rapidly spreading disease. Drawing on his background at Merck and in pharmaceutical forecasting, he described ivermectin as a long-standing, widely used medication with billions of doses administered globally and an extensive safety record. He argued that early laboratory and clinical evidence suggested antiviral activity against SARS-CoV-2 and that early treatment use showed the greatest benefit. He presented pooled data from numerous clinical trials which, in his analysis, demonstrated significant reductions in mortality, hospitalization, and mechanical ventilation.
Hooper testified that regulatory agencies such as the FDA publicly discouraged ivermectin use and characterized it as dangerous despite its long safety history. He suggested structural incentives contributed to this response, including Emergency Use Authorization requirements that no adequate alternative treatment exist, and legal restrictions preventing companies from promoting off-label uses. He further criticized the TOGETHER Trial and other widely publicized studies, arguing that press releases preceded full data review and that subsequent analyses identified serious methodological concerns. He emphasized that many smaller trials showed positive outcomes but were dismissed for not meeting conventional 95% statistical significance thresholds.
He also testified that misuse of statistical significance led to misleading conclusions, explaining that small underpowered studies could show strong clinical benefit yet be labeled ineffective. Hooper proposed structural reforms including incentivizing research into off-patent drugs, allowing broader dissemination of off-label information, funding large publicly supported trials early in pandemics, reducing regulatory concentration of power, and separating safety evaluation from efficacy determination. He concluded that dissuading use of ivermectin likely contributed to avoidable harm and that reforms are needed to prevent similar outcomes in future public health emergencies.
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