Past FDA Heads Warn Against Using Malaria Drug for Coronavirus

April 6, 2020, 8:12 PM

Former FDA leaders cautioned against shortchanging science in the rush to make available unproven Covid-19 treatments like the antimalarial drug hydroxychloroquine, which President Donald Trump touts.

The comments Monday from Margaret Hamburg and Mark McClellan—both former commissioners of the Food and Drug Administration—join a growing body of voices in the scientific community warning about providing “false hope” to patients looking for a treatment.

“We totally understand how if you’ve got Covid-19 and serious complications and nothing that works, you want access to something,” McClellan said during a briefing organized by the Commonwealth Fund. “It’s also important to keep in mind that what we really want for the most people to have the best outcomes is to learn as quickly as possible about what treatments can really help them.”

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, issued similar warnings over the past few weeks. He cautioned that the studies aren’t well-controlled to prove hydroxychloroquine treats Covid-19 and the evidence in its favor is anecdotal.

Trump began touting hydroxychloroquine, which is used to treat malaria, lupus, and rheumatoid arthritis, as a potential treatment in March. He reiterated that position at Sunday’s press conference, saying, “I’m not a doctor, but I have common sense.” His comments have sparked a surge in demand, causing shortages.

The FDA hasn’t approved any drugs or vaccines for Covid-19 but issued an emergency authorization allowing doctors to prescribe two malaria drugs, chloroquine and hydroxychloroquine, to Covid-19 patients.

The drug can have serious side effects for people with heart disease, which is why its use on Covid-19 patients needs to be tracked, McClellan said on another press briefing, set up by the Alliance for Health Policy. The medication can cause an irregular heartbeat when mixed with certain antibiotics, he said.

McClellan is the founding director of the Duke-Margolis Center for Health Policy at Duke University and led the FDA under the George W. Bush administration.

Hamburg, who was the FDA commissioner for most of the Obama administration, rejected the argument that amid a crisis anything is better than nothing because even promising treatments can have severe side effects. Hydroxychloroquine has significant toxicity “so simply shifting it over to another area of treatment without doing the studies is of concern.”

“We all feel this sense of urgency to get answers, to get treatments to people who need” them, Hamburg said during the Commonwealth Fund call. “There are many ways to do that robust scientific evaluation.”

To contact the reporters on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com; Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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