WASHINGTON (CN) — In a blow to President Donald Trump’s longtime advocacy of an unproven drug to fight Covid-19, the Food and Drug Administration revoked the emergency use of hydroxychloroquine as a treatment for the virus that has now killed more Americans than World War I.
“Based on a review of new information and a reevaluation of information available at the time the [emergency use authorization] was issued, FDA now concludes that these criteria are no longer met,” Denise M. Hinton, chief scientist for the FDA, wrote in a letter sent Monday to Gary L. Disbrow, director of medical countermeasure programs at the Department of Health and Human Services.
The letter was in response to a request to pull the drug from continued use under the emergency authorization granted in late March.
“FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of [hydroxychloroquine] may be effective in treating Covid-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” Hinton added.
In a March press briefing announcing his interest in the FDA approving the drug for treatment of the respiratory disease caused by the coronavirus, Trump said, “It’s been around for a long time, so we know if things don’t go as planned, it’s not going to kill anybody
“I think it could be a game changer and maybe not,” the president added. “But it could be, based on what I see, a game changer. I want every American to know we’re doing what we can.”
Trump has since continued to praise the drug, suggesting people should take it even when not experiencing symptoms despite evidence suggesting it can cause damage heart damage. He even claimed last month that he was taking hydroxychloroquine.
Hydroxychloroquine was first used as an anti-malaria treatment but is also used to treat lupus and rheumatoid arthritis. Trump’s frequent support for the drug reportedly led to fast-track approval for its emergency use against Covid-19, as well as a deal approved by the Justice Department’s antitrust division for pharmaceutical wholesaler AmerisourceBergen to distribute the drug in communities ravaged by the coronavirus pandemic in the Northeast.
The deal raised eyebrows when it was announced in April. Dr. Dena Grayson, a physician who helped research an antiviral drug to combat the deadly Ebola disease, said while it’s not unusual for the country to stockpile a drug during an outbreak, hydroxychloroquine “objectively has not shown any benefit for Covid-19.”
“But we’ve also seen, of course, treatment-related deaths,” Grayson added.
The FDA said Monday that earlier tests showed “potential benefits of [the drug] when used to treat Covid-19 outweigh the known and potential risks of such products” based on the available science at the time the emergency authorization was given.
But with numerous studies since completed, the agency now believes “neither a favorable impact of [the drug] on viral shedding nor an established clinical benefit of a decrease in viral shedding has been borne out by data and reports available since the [emergency order] was issued.”
Among the studies cited in the report was one released in late May that found deaths actually spiked with use of the controversial drug.
“Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regiments are poorly evaluated in Covid-19,” according to the study authored by heart specialist Dr. Mandeep Mehra. The study, published in the Lancet, examined over 10,000 patients at 617 hospitals around the world.
That study was released just days after Trump shocked the country by announcing he had been taking hydroxychloroquine for “a couple of weeks” as a preventative measure.
But even before the Lancet study, the drug and Trump’s interest in it was raising red flags.
After being terminated as head of U.S. vaccination efforts against the pandemic, Dr. Rick Bright filed a whistleblower complaint saying he was terminated after questioning the administration’s rush to use the drug in the face of public safety concerns.
“Dr. Bright opposed the broad use of chloroquine and hydroxychloroquine as lacking scientific merit, even though the administration promoted it as a panacea and demanded that New York and New Jersey be ‘flooded’ with these drugs, which were imported from factories in Pakistan and India that had not been inspected by the FDA,” Bright wrote in the complaint.
Trump last mentioned the drug in a brief exchange with the press in late May, when he said he’d taken the drug for “just about two weeks.”
“I think it's another day. And I'm still here. I'm still here,” he said, defending its use before announcing he’d also taken a test for Covid-19 for which he “tested very positively in a -- in another sense,” before clarifying he tested negative for the virus.
Monday’s FDA letter says hydroxychloroquine is “no longer authorized… to treat hospitalized patients for Covid-19,” but previously approved shipments of the drug can be distributed in interstate commerce.
As of Monday, the United States has seen over 117,000 deaths from Covid-19 — more than the total number of Americans killed in World War I.
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