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Harvey Risch is a brilliant contributor to the knowledge base of biomedical research. Dr. Risch was the first to publish on hydroxychloroquine, very early in the pandemic, summarizing in the American Journal of Epidemiology evidence that hydroxychloroquine (HCQ) was associated with lowered mortality risk in a dose-dependent manner. He advocated very strongly that the world should not wait for the outcome of long-term randomized clinical trials, showing a correct understanding of the level of evidence required for off-label prescription during emergencies. This publication has had more than 140,000 views. You can read his, and the world’s first review of the clinical evidence of hydroxychloroquine here.

Dr. Risch also served as the principal scientist in the large Brazil hydroxychloroquine trial, published in Travel Medicine and Infectious Disease. That study found day 6 use of HCQ, prednisone or both significantly reduced hospitalization risk by 50–60%. It is inconceivable that in the review of the evidence Dr. Risch presented that individuals like Anthony Fauci could not have known about what the studies were truly indicating. You can read the large Brazil HCQ study here.

Dr. Risch has also worked tirelessly to educate the public on hydroxychloroquine and other aspects of COVID-19, such as this piece in Newsweek in July, 2020 “Tireless” does not truly capture his efforts; he has appeared in interviews on television at least 76 times to date, and had provided testimony for important proceedings, giving decision makers no reason not to see and understand the value of HCQ for outpatient care for COVID-19.

It is a near universal truth that academic training, especially in the medical and biological sciences, attempts to force specialization. When individuals in academia continue to gather new skills via formal training, they break the mold. In addition to his medical training, Dr. Risch obtained a PhD in mathematical modeling of infectious epidemics and has actively published on that challenging topic.  He is Professor of Epidemiology at Yale School of Public Health, widely recognized as one of the premier public health institutions in this country, and has published over 350 peer-reviewed scientific research papers. His publications have generated over 41,000 citations of those papers in the medical and scientific literature.

One of the distinctions that Dr. Risch carries is that he has no financial conflicts of interest in HCQ or any early treatment for COVID-19. Dr. Risch’s early vision has been supported by the clinical experience of many physicians – and he is co-author on the landmark “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” with world-renown COVID-19 authority Dr. Peter McCollough.

Critics of Dr. Risch accuse him of weakening the standards for clinical adoption of treatment for COVID-19. These critics are hazards to public health in part because they fail to respect that off-label use is allowed when no standard of care exists (such as with COVID-19), and that Emergency Use Authorization (EUAs) do not require the same high level of evidence that clinical options require for success in translational efforts for medical options during non-emergencies. They apparently are unaware that the rules have changed for COVID-19 related studies: Real World Data and Real World Evidence can now be given full consideration by regulatory agencies (See FDA Guidance, 9/30/2021).

One of Dr. Risch’s interviews was with Dr. Naomi Wolf on The Daily Clout. Co-guests included Dr. Howard Tenenbaum, and Dr. Paul Alexander.

And here is a highly informative academic presentation (aired June 25, 2021) that tells the story of hydroxychloroquine and its abuse by false accusations and fake studies. He also highlights the Bradford-Hill Criteria for causality, a topic we’ll be reviewing in courses at IPAK-EDU.

NIAID Director Anthony Fauci has rejected hydroxychloroquine using language like “all the credible studies”. There are limitations to the available science on hydroxychloroquine, not the least of which have included faked studies conducted and published to cast dispersion on the inexpensive drug. Other limitations include small sample sizes of some studies; however, if Fauci and Francis Collins had prioritized large, well-conducted studies of hydroxychloroquine, this would not be a limiting issue. The massive number of studies to date that find an effect place hydroxychloroquine high among the candidates for likely to succeed in a thorough, objective analysis.

The fact that people are still dying without any ambulatory in-home care is the crime of the century.

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Featured image is from Yale.edu