The agency is ending its emergency use authorization after multiple clinical trials showed the drug was ineffective.
The Food and Drug Administration this week pulled emergency use authorizations for two drugs Donald Trump touted as COVID-19 cures, despite evidence that they may lead to death or cause other health complications.
The FDA ended its emergency approvals for hydroxychloroquine and chloroquine — two anti-malarial drugs being examined as possible treatments for the coronavirus — on Monday based on multiple tests. According to Politico, the agency withdrew the authorizations "after reviewing new information from large clinical trials" that showed the drugs were largely ineffective.
"Today's request to revoke is based on new information, including clinical trial data results, that have led [the Biomedical Advanced Research and Development Authority] to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug's potential benefits for such use do not outweigh its known and potential risks," FDA chief scientist Denise Hinton wrote in a letter Monday.
Under the emergency authorization, providers had temporarily been able to use the two medications in "emergency situations" without FDA approval.
As Politico noted, the FDA had been criticized previously for allowing the emergency use authorizations, which some saw as "caving to political pressure" imposed by the Trump administration.
Trump himself has repeatedly touted the drugs' effectiveness, ignoring concerns that they were ineffective or dangerous and suggesting they be used to treat COVID-19 patients.
"HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine," Trump tweeted in March.
He praised the FDA's emergency authorization, saying the agency "has moved mountains - Thank You!"
In April, Trump recounted a conversation with a COVID-19 patient who said they felt better after taking hydroxychloroquine. "The way she spoke," Trump told reporters, "it was like a miracle. And this was not a fan of mine, but she's a fan of my now."
Trump acknowledged that the drug was not a panacea, but urged people to try the unproven remedy regardless. "What do you have to lose?" he asked at another event that month.
On April 24, the FDA issued a warning that the medication should not be used for COVID-19 out of hospital or clinical trial settings "due to risk of heart rhythm problems."
That did not stop Trump from announcing in May that he was taking the hydroxychloroquine himself, as a prophylaxis. "I started taking it, because I think it's good," he told reporters.
Three large studies have so far shown little benefit from the medication as a coronavirus treatment. Several smaller studies have reached similar results.
Eric Topol, director of the Scripps Translational Science Institute, told Science Magazine at the time that Trump's "obsession" with the drug was problematic.
"It just seems like we are ignoring signal after signal," he said. "We’d be better off shifting our attention to drugs that might actually work."
Trump, for his part, has dismissed any negative studies of the drug as biased against him personally.
"If you look at the one survey, the only bad survey, they were giving it to people that were in very bad shape, they were very old, almost dead. It was a Trump enemy statement," he said in May regarding a study of Veterans Administration hospital patients that showed more deaths among those who took the drug than those who did not.
Published with permission of The American Independent Foundation.