Emergency use authorization for hydroxychloroquine for COVID-19 should never have been issued

Statement of CSPI president Dr. Peter G. Lurie

The Food and Drug Administration’s revocation today of the Emergency Use Authorization for hydroxychloroquine and chloroquine is unquestionably in the best interests of patients. And it is to FDA’s credit that it was able to take a fresh look at the data and recognize the error of its ways. But the underlying question remains why FDA authorized the product on such skimpy evidence in the first place, and why it caved in to pressure from the White House in doing so. We must also ask ourselves how many promising drugs for COVID-19 went unstudied as researchers across the globe pivoted to address the latest evidence-free pronouncements from the White House podium.

In the end, the lesson here is the same it always is in science: answers to difficult research questions do not come from wishful thinking or the recommendations of television hosts; they come from the painstaking efforts of committed researchers using time-tested clinical trial methods. Had we done that, this debacle would have been avoided, and a number of COVID-19 patients who apparently died from hydroxychloroquine cardiac toxicity would still be with us.