FDA Nixes Trump Again on Chloroquine Use
Despite the repeated recommendations from president Trump to use chloroquine to treat coronavirus patients, principal deputy commissioner Amy Abernethy this week reiterated that a randomized controlled trial is the “most appropriate way” to determine whether the malaria drug is safe and effective for such use. Speaking remotely at the Wall Street Journal Health Forum 3/24, Abernethy said several studies have been announced or launched within the past week, including a University of Minnesota study that will evaluate hydroxychloroquine in healthcare workers and those residing with sick family members. “As the question of chloroquine and hydroxychloroquine for Covid-19 comes to the table, we need to ask in a judicious way, what are the data that support this particular intervention, and also support this invention over other potential interventions?” she said.
Trump was still singing the drug’s praise when he called Fox News’ Sean Hannity 3/26 for a live interview. Trump praised FDA and commissioner Steve Hahn for the fast turnaround to allow New York to administer chloroquine and collect data under a clinical trial earlier this week. So far, he told Hannity, there has not been any bad news or any news at all, “but a lot of people are saying this could be the big answer.”
Trump’s fascination with chloroquine was set in motion through discussions with Oracle co-founder Larry Ellison. according to the Washington Post. Ellison recently helped arrange a partnership between Oracle and the government to crowdsource an idea to collect data in real time from doctors trying out those and other unproven drugs on covid-19 patients, the Post said.
Trump had to be dissuaded last week, according to the Post, from invoking emergency authorities HHS secretary Alex Azar presented to him to approve chloroquine for immediate use. Hahn and other officials pushed back on the idea, urging the president to wait for the results of randomized clinical trials that meet FDA’s standards, it said. “A senior administration official said Azar was not advocating for immediate approval but presenting the president with options he had requested,” the paper reported. “The other officials in the room were stunned at the suggestion and urged Trump to rely on the clinical trials.”
Meanwhile, chloroquine is missing in former FDA commissioner Scott Gottlieb’s projection for a therapeutic to help the U.S. out of the current mess. “We should be able to develop a recombinant antibody by summer that directly targets the virus,” he said on Twitter 3/27. “This can be both a prophylaxis and a treatment. Regeneron is one group developing this. They successfully made such a drug against MERS and Ebola. We may also have by summer or fall an anti-viral drug that acts directly against the virus. Remdesivir by Gilead is one of many agents showing preliminary activity. Such a drug can be used as both treatment and potentially post-exposure prophylaxis if its side effect profile is good. If we can couple massive surveillance to identify sparks of transmission early, before they become fires; and couple that with a therapeutic to prevent infection in those at highest risk or treat early those who may get into trouble, we can turn Covid-19 [into] a manageable threat.”