The FDA Revokes Its Emergency Use Authorization for Hydroxychloroquine

Attempts to review the drug have been plagued by confusion. In May, The Lancet, one of many best-regarded medical journals on the planet, retracted a hydroxychloroquine study last month when its knowledge was cast into doubt. In early June, researchers on Oxford’s recovery study, a large-scale, randomized research of the efficacy of several medication in treating Covid-19 patients, reported that they’d noticed no benefit from hydroxychloroquine. The outcomes have been so unpromising that the researchers ended the hydroxychloroquine arm of their study prematurely. Another randomized study from Shanghai Jiao Tong University discovered that hydroxychloroquine didn’t lower mortality in Covid-19 patients. But this study was open-label, which implies that each clinicians and patients knew who was receiving treatment. Both of those research have been cited prominently within the FDA’s decision to revoke the EUA.

So far, just one large-scale randomized, double-blind study of the drug’s utility has been printed in a scientific journal; performed by researchers in the University of Minnesota, the study discovered that hydroxychloroquine was no better than a placebo at stopping an infection amongst individuals exposed to the virus, a use generally known as post-exposure prophylaxis.

And earlier today, the World Health Organization dropped hydroxychloroquine from its worldwide Solidarity clinical trial of 4 totally different treatments, following the outcomes of these different studies.

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Issuing an EUA within the absence of convincing proof is not always unjustified, Wachter says. “The FDA has this very tricky balance that it’s always weighing between speed and safety,” he says. Early in a pandemic, he provides, “it’s not unreasonable to tilt the playing field a little bit more toward speed.”

But to some observers, the hydroxychloroquine EUA appears to have been motivated by components outside of science. “You can’t help but think that there was political pressure,” says Derek Lowe, a pharmaceutical expert and author of the drug discovery blog In the Pipeline. Wachter concurs. “Assuming that the president of the United States had never mentioned the drug in public, and certainly never touted its potential benefits, would that have happened?” he asks. “I’m guessing it would not have.”

For Lowe, Wachter, and Nori alike, the questions raised by the FDA’s speedy issuance—and retraction—of an EUA for hydroxychloroquine raise concerns about what would possibly happen once a Covid-19 vaccine candidate needs approval. “There are a lot of people, and I’m one of them, worried that perhaps Trump or the higher-ups in the administration will end up picking a favorite vaccine the way they picked hydroxychloroquine,” Lowe says. “And that would of course be a terrible idea, because we’re going to have an awful lot of data to collect about an awful lot of candidates before we start talking about which one to approve first.”

Even when information about vaccine efficacy and uncomfortable side effects become accessible, approval decisions are unlikely to be simple. Wachter anticipates that the FDA should decide whether or not to permit vaccines to be distributed earlier than their long-term security can be definitively proven and weighed towards their advantages. “Do we wait three months, given how many people are going to get infected and how many people are going to die in those three months, or do we move faster?” he asks. “I think that’s an incredibly hard call.”

For his personal part, Lowe urges warning amongst scientists who hope to find the following big thing in Covid-19 treatment. “We are going to be in this for a while,” Lowe says. “So, we should take a deep breath and try to do this right. Measure twice, cut once.”