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March 19, 2020 03:23 PM

Trump wrongly claims that FDA approved COVID-19 drug

Michael Brady
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    Modern Healthcare Illustration / Getty Images

    The Trump administration on Thursday sent mixed messages about whether an antimalarial drug had been approved by the U.S. Food and Drug Administration to treat coronavirus.

    President Donald Trump said during a press conference that the FDA had approved hydroxychloroquine, also known as chloroquine, to treat patients suffering from coronavirus. Doctors would soon be able to prescribe it to their patients, according to the president.

    "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," Trump said.

    But FDA Commissioner Dr. Stephen Hahn walked back Trump's remarks minutes later, clarifying that the FDA will conduct a clinical trial to determine whether chloroquine is a safe and effective coronavirus treatment and at what dosage.

    "That's a drug that the president has directed us to take a closer look at," Hahn said. "We want to do that in the setting of a clinical trial, a large pragmatic clinical trial to actually gather that information and answer the question that needs to be answered."

    Providers have used chloroquine to prevent or treat malaria since 1944. Research shows that it can effectively prevent and treat the virus that causes severe acute respiratory syndrome, or SARS, which is closely related to COVID-19.

    Trump also said that remdesivir, a drug developed by Gilead Sciences to treat the Ebola virus that was unsuccessful, was "essentially approved" to treat COVID-19. The University of Nebraska Medical Center in Omaha is conducting a randomized, controlled trial to test the drug.

    "Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes," said Dr. Anthony Fauci, U.S. Coronavirus Task Force member and director of the NIH's National Institute of Allergy and Infectious Diseases, when the trial began in February.

    Both Trump and Hahn said that "compassionate use" could play an essential role in treating coronavirus patients until effective treatments are approved. Compassionate use allows the FDA to authorize providers to treat seriously ill patients with experimental drugs if other treatments are unavailable.

    "While there are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19, there are several FDA-approved treatments that may help ease the symptoms from a supportive care perspective," the FDA said in a statement.

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        • - Hospital of the Future (Fall)
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