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Demanding proof when time is short and when there is highly suggestive observational evidence has been condemned by Drs. George Fareed, Michael Jacobs, and Donald Pompan in an open letter to Dr. Fauci.
They point out that the FDA has approved many drugs without RCTs—penicillin was so efficacious in treating pneumonia that there was no need for random Controlled Trials (RCTs). Moreover, RCTs are not designed to test the efficacy of a therapy in high-risk outpatient settings before a patient is notified of the results of a test for COVID-19.
It cannot be ethical for public health bodies to demand impossible standards of proof for potential lifesaving therapies.
To require an RCT for the HCQ triple therapy is indeed unethical; evidence supporting its use comes from large patient series, controlled trials, and even a natural experiment in the Brazilian state of Pará.
In assessing ongoing patient outcomes, keep in mind that observations might be affected should the SARS-CoV-2 virus lose virulence. Spanish authorities report that fatality rates have fallen, even among elderly patients, which would be consistent with reduced SARS-CoV-2 virulence. This, too, should be considered by public authorities in assessing the risks associated with reopening schools.
Yet rather than engage in proper debate, Dr. Fauci has resorted to name-calling. “The pushback has been furious,” Risch writes. Dr. Fauci “has implied that I am incompetent, notwithstanding my hundreds of highly regarded, methodologically relevant publications in peer-reviewed scientific literature.”
Dr. Fauci’s position calls to mind that of English statistician Ronald A. Fisher, who in the 1950s vehemently argued against Hill and Doll and their finding that smoking causes lung cancer, on very similar grounds to those used by Dr. Fauci to dispute the efficacy of HCQ—that observational data cannot prove causality. This is an extraordinary position for America’s leading health official to adopt; by the same logic, Dr. Fauci would deny the evidence that tobacco smoking kills.