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U.S. Virus Guidelines Reject Trump-Backed Drug Combination (1)

April 21, 2020, 6:47 PM

A panel of medical experts convened by the U.S. National Institutes of Health recommended against the use of a drug combination touted by President Donald Trump for Covid-19 patients.

The NIH panel, made up of 50 doctors, pharmacy experts and government researchers and officials, specifically recommended against the use of the anti-malaria drug hydroxychloroquine in combination with the antibiotic azithromycin.

The malaria pill can cause heart issues, and the NIH panel warned of the potential for harm from the combination.

Trump has repeatedly backed the use of the malaria pill or the combination of drugs on Twitter and at numerous briefings of the Coronavirus Task Force, though some medical experts in his administration have cautioned about the lack of evidence. In a press briefing on April 5th, he said: “What do you have to lose? Take it.”

“Although reports have appeared in the medical literature and the lay press claiming successful treatment of patients with Covid-19 with a variety of agents, definitive clinical trial data are needed to identify optimal treatments for this disease,” the NIH panel said in its report, giving broad recommendations for the treatment of Covid-19 patients.

The panel was lead by Roy Gulick, chief of infectious diseases at Weill Medical College of Cornell University in New York City, and two scientists from the NIH. More than two dozen academics, pharmacy experts and doctors from around the U.S. were part of the group, as were represantatives from the Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs and the Centers for Disease Control and Prevention.

One of Gulick’s co-chairs on the panel is Clifford Lane, a top official at the NIH’s National Institute for Allergy and Infectious Diseases. That division of the NIH is led by Anthony Fauci, a member of Trump’s task force on the virus.

“HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine,” he said in a March 21 tweet, following up to urge that they should “be put in use IMMEDIATELY. PEOPLE ARE DYING, MOVE FAST, and GOD BLESS EVERYONE!”

Trump’s championing of the drug has led to an enormous focus on hydroxychloroquine as a potential treatment, amid dozens of therapies that are being explored. A few small, early studies suggested positive outcomes from the drug and gained wide attention. But the picture has grown far murkier as more data has emerged.

An recent analysis of 368 patients from the Veterans Administration looked at how people with Covid-19 fared after getting the standard of care, hydroxychloroquine alone, or the combination.

Study Results

In the study, patients who received both hydroxychloroquine alone and the combination of hydroxychloroquine and azithromycin were more likely to have severe Covid-19 disease, compared to people who didn’t get the drugs. But even after statistically adjusting for those differences, patients getting hydroxychloroquine alone still had a higher death rate than those not getting it. There was no clear difference in death rates among those getting the combination compared to those getting no drug.

Results from the unpublished study were first reported by the Associated Press.

In Brazil, part of another clinical trial was suspended because patients getting higher doses of chloroquine, a related drug, appeared to be more likely to die, according to a preprint of the study that had not yet been published in a scientific journal.

Other studies of the drugs in thousand of patients are ongoing around the world to try and determine whether the drug might work as a treatment or a preventive measure.

If hydroxychloroquine or the closely-related drug chloroquine is given alone, patients should be monitored for side effects, including the heart rhythm disturbances that can lead to sudden death, the NIH panel said.

The panel said that no drug has been proven effective for use in patients with the diseases caused by the new coronavirus, and didn’t endorse the use of any other therapies outside of clinical trials. The panel’s recommendations for now focus on supportive care, such as oxygen.

The group also said medicines commonly used to treat HIV, including AbbVie Inc.’s Kaletra, should be avoided because of negative clinical trial data and potential harm to patients.

(Updates with details on recommendations throughout)

--With assistance from John Lauerman and Anna Edney.

To contact the reporters on this story:
Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net;
Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editors responsible for this story:
Drew Armstrong at darmstrong17@bloomberg.net

Reg Gale

© 2020 Bloomberg L.P. All rights reserved. Used with permission.

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