Azar, Trump Mislead on FDA’s Hydroxychloroquine Decision

In a meeting at the White House, Health and Human Services Secretary Alex Azar left the misleading impression that the Food and Drug Administration’s decision to revoke its emergency use authorization of hydroxychloroquine and chloroquine for COVID-19 “removes a potential barrier” and makes it easier to access the drugs. The FDA’s action does the opposite.

Following Azar’s lead, President Donald Trump also falsely accused a journalist of asking a “very inaccurately stated question” about the FDA’s emergency use authorization, or EUA, and continued to point to unscientific anecdotal evidence to insist that hydroxychloroquine is effective against COVID-19, despite growing evidence to the contrary.

The FDA announced on June 15 that it had revoked its EUA for hydroxychloroquine and chloroquine because the drugs are “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” and that the “known and potential benefits” of the drugs “no longer outweigh” the risks — which can include “serious cardiac adverse events and other potential serious side effects.”

The FDA had issued the EUA back in March to allow adult and some adolescent patients hospitalized with COVID-19 to obtain the drugs from the Strategic National Stockpile “when clinical trials are not available, or participation is not feasible.”

But accumulating evidence, including a large randomized controlled trial that the agency cited in its decision, has found that hydroxychloroquine does not help hospitalized COVID-19 patients. Other trials also indicate that the drug does not prevent the disease if given shortly after exposure to the coronavirus.

The political spin began at a June 15 roundtable discussion at the White House when a journalist asked Trump to respond to news of the FDA’s revocation. The reporter paraphrased the agency as saying the drugs were