Emergency use authorizations are a threat to science

In the case of hydroxychloroquine, a drug that is often prescribed to treat rheumatoid arthritis, its use to treat COVID-19 was highly publicized, politicized, and polarized. The FDA granted hydroxychloroquine EUA status on April 27, and less than two months later, on June 15, it was revoked after it became clear that at least one study supporting its use was based on questionable data and new scientific evidence showed that it had little to no effect in treating COVID-19 patients. Other research even indicated adverse events in patients who took it.

In all cases, even if a drug does turn out to be effective, granting a therapy EUA before it has completed clinical testing undermines the data and stunts the ability to properly collect and analyze that information to ultimately inform treatment decisions. When the FDA granted an EUA for remdesivir, our clinical trials on the drug came to a stop. Patients are less inclined to join a trial, in which they may or may not receive the drug, when they can just ask and receive the treatment that has been granted EUA status. And it’s unethical to ask a patient to participate in a clinical trial in which they may not receive treatment that has been approved by the FDA.