It's been more than 2 months since President Donald Trump touted malaria drugs as a possible "game-changer" for coronavirus treatment, and the FDA quickly signed off on their emergency use during the pandemic. But now that controlled studies have found no benefit from chloroquine or hydroxychloroquine in COVID-19 patients, the agency is pulling that authorization.
The move is based on a review of data generated since the initial emergency use authorization, FDA chief scientist Denise Hinton wrote in a letter to BARDA official Gary Disbrow. After reviewing recent findings, FDA found the drugs are “unlikely to produce an antiviral effect” at the previously recommended doses.
A clinical trial couldn’t reproduce initial reports of decreased viral shedding, she added. Additionally, a large randomized trial “showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalized patients with COVID-19,” Hinton wrote.
In all, the FDA no longer believes the benefits of the medicines outweigh the risks.
The move follows a whirlwind few months for the drugs and those involved in the saga. In the early stages of the pandemic, reports out of France spurred interest in the medicines, and Trump started praising their promise against COVID-19. He tweeted in March that HCQ and azithromycin, “taken together, have a real chance to be one of the biggest game changers in the history of medicine.”
But controlled trials have yet to show the benefits described in those early, anecdotal reports. The FDA signed off on an emergency use authorization in late March, but less than a month later, the agency warned that the drugs are too risky to use outside of hospitals. Then, in May, Trump said he had been taking hydroxychloroquine to prevent infection.
The drugs also were a centerpiece of the high-profile ouster of BARDA head Rick Bright. In his whistleblower complaint after he was transferred out of his job, Bright outlined the administration's efforts to push the medicines. In March, an HHS official had instructed one of Bright's colleagues to check out data on the drugs, adding that they could be a "big immediate win."
Bright felt the drugs lacked solid evidence, but his concerns fell on deaf ears, he said. He decided to corroborate a reporter’s reporting on the subject, and that led to his transfer, he believes.