INSERM, a successor to the French National Institute of Health, recently had results from the Phase 3 DisCoVeRy clinical trial published in The Lancet, Infectious Diseases. The major French investigation explored the antiviral efficacy of remdesivir, the only therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19.
A controversial move by the FDA as the pivotal American clinical trial included controversial moves by the sponsor—the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH)—to change the primary endpoint toward the end of the study.
It turns out that the drug didn’t meet this endpoint, so as directed by NIAID Director Anthony Fauci, the apex government research institute worked with the industry sponsor, Gilead, to merely modify the endpoint to reduce the duration of hospitalization. The final results in that American trial weren’t impressive—a mere few days reduction in hospitalization.
Meanwhile, the World Health Organization (WHO) Solidarity trial concluded remdesivir brought no benefit. The FDA proceeded first to issue an emergency use authorization (EUA). A few months lat…