Early results of the first clinical trial of remdesivir against placebo in coronavirus were announced at the White House Apr 30, and showed modest benefits, according to The New York Times. Surviving patients given remdesivir were discharged 4 days sooner than patients given placebo, though no criteria were given for determining improvement. Death rates were not significantly different. About 25 percent of patients receiving remdesivir had potentially severe side effects, including multiple organ dysfunction, septic shock, acute kidney injury, and low blood pressure. Another 23% showed evidence on lab tests of liver damage.
Gilead’s own press release revealed the side effect of acute respiratory failure in 6 percent of patients in the remdesivir 5-day treatment group, and 10.7 percent of patients in the 10-day treatment group, clearly ominous findings with a drug designed to treat respiratory failure caused by COVID-19.
Dr. Steven Nissen, Cleveland Clinic cardiologist who has conducted dozens of clinical trials, explained to The New York Times: “The disclosure of trial results in a political setting, before peer review or publication, is very unusual. Scientists will need to see figures on harms associated with the drug in order to assess its benefits…. This is too important to be handled in such a sloppy fashion.”
Dr. Michele Barry, a global health expert at Stanford University, expressed concern about Dr. Fauci’s overly enthusiastic praise for remdesivir: “It is unusual to call a drug the ‘standard of care’ until peer review of data and publication, and before studies have shown benefit in mortality.”
The leading communicable disease specialist in France, Professor Didier Raoult, asked about another odd aspect of the remdesivir trial: “Could Anthony Fauci explain why the investigators of the NIAID remdesivir trial did change the primary outcome during the course of the project?”Death as the primary outcome was moved to a secondary outcome, and days to recovery became the primary trial outcome. Changing the primary outcome before trial results are completed is highly unusual and suggests “p-hacking”—manipulating the data to get a statistically significant “p value.”
Is someone stacking the deck in Gilead’s favor? Nineof the experts on the NIH COVID-19 Panel recommending treatment options have disclosed financial support from Gilead. Why did these nine experts not recuse themselves? Did financial conflicts of interest affect the recommendation against HCQ, the older, safer, cheaper medicine, and for use of remdesivir, the new, expensive experimental medicine, based on weak, not-yet-peer-reviewed evidence?