Less than 24 hours after President Donald Trump publicly workshopped his idea to disinfect coronavirus patients with household cleaning products, the Food and Drug Administration warned consumers to steer clear of another unproven treatment Trump has been hawking to the American people: hydroxychloroquine.
Health experts at the FDA put out a statement on the agency’s website Friday advising against the widespread use of the malaria drug hydroxychloroquine, which the president touted as a possible treatment for COVID-19 during his daily White House press conference on March 21 and again during his April 4 press conference.
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“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19,” said the FDA’s statement. “The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine.”
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Hydroxychloroquine was first pitched as a potential medication for the coronavirus in a French study back in March. The study suggested that the drug, when combined with the drug azithromycin, better known as a Z-Pak, could benefit those fighting the deadly respiratory disease. However, the study was later disavowed by the journal that first published it.
The drug is known to increase the health risks of those with pre-existing heart and kidney conditions, according to the FDA. The agency encouraged healthcare professionals to restrict its use to controlled clinical trials only.
The FDA’s recommendation comes as leaked emails published by Vanity Fair Friday morning show evidence that the president’s administration had big plans for the unproven drug, pressuring its top health officials to push for its use.
In an April 4 email with the subject line “hydroxychloroquine,” Department of Health and Human Services Assistant Secretary Brett Giroir told various government officials in FEMA, HHS, and the U.S. Navy that they wanted to see the drug have a significant presence in the states hit hardest by the coronavirus.
“Really want to flood NY and NJ with treatment courses,” the email reads. “Hospitals have it. Sick out patients don’t. And can’t get. So go through distribution channels as we discussed. If we have 29 million perhaps send a few million ASAP? WH wants follow up in AM.
We can get a lot more of this. Right Bob? Millions per week?”
An email sent by FEMA administrator Pete Gaynor an hour later implies that FDA commissioner Stephen Hahn was OK with the administration’s plan to make the drug available for widespread use.
“Hahn asked to distribute to hospitals and the drug stores,” Gaynor replies.
In a third leaked email from Gaynor sent later that night, the FEMA head indicated he was also working with Navy Rear Adm. John Polowczyk on the effort.
“Me and Adm P are on it,” Gaynor wrote according to Vanity Fair. “More to follow in the am.”
News of the administration’s internal push for the use of hydroxychloroquine comes just days after Dr. Rick Bright, the former head of the U.S. Biomedical Advanced Research and Development Authority, was ousted for speaking out against the effectiveness of the drug.
In a statement released Wednesday, Bright called it a form of retaliation from the Trump administration.
“I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the Covid-19 pandemic into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit,” Bright said.
In his statement, Bright calls out his opposition to hydroxychloroquine specifically, calling it dangerous to use outside of a controlled environment.
“While I am prepared to look at all options and to think ‘outside the box’ for effective treatments, I rightly resisted efforts to provide an unproven drug on demand to the American public,” he said of the Trump administration’s plan for the drug. “I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician. These drugs have potentially serious risks associated with them, including increased mortality observed in some recent studies in patients with COVID-19.”
Cover: President Donald Trump speaks about the coronavirus in the James Brady Press Briefing Room of the White House, Thursday, April 23, 2020, in Washington, as Vice President Mike Pence listens. (AP Photo/Alex Brandon)
