President Donald Trump’s unprompted admission that he’s been taking hydroxychloroquine for a week and a half is aligned to some degree with medical research that aims to understand if the controversial drug can prevent infections with the coronavirus in high-risk frontline workers.
Hydroxychloroquine, which is approved by the Food and Drug Administration to treat malaria, lupus and rheumatoid arthritis, is not a proven treatment or prophylaxis for COVID-19. It received emergency-use authorization from the FDA in mid-March to be used in certain clinical settings as a treatment for COVID-19 patients. But, in the two months since then, medical experts have raised questions about the heart risks associated with the drug and its efficacy against the virus — and how those concerns play out against a backdrop of political maneuvering.
“You’d be surprised at how many people are taking it, especially the frontline workers before you catch it,” Trump told reporters on Monday. “I happen to be taking it.”
Several White House staffers have recently tested positive for the coronavirus, including Katie Miller, Vice President Mike Pence’s press secretary, as well as one of Trump’s personal valets. It is unclear whether Trump was exposed to any of those individuals; however, a letter from Dr. Sean Conley, the White House physician, that was shared on social media mentions that a member of Trump’s support staff tested positive for COVID-19.
Since the earliest days of the pandemic in the U.S., Trump has been promoting hydroxychloroquine and chloroquine, an older formulation of the same drug. His remarks in favor of the decades-old medicine likely helped spur a run on the drug that created a supply shortage for the patients who already take the treatment for lupus and rheumatoid arthritis.
But a series of medical studies, many of which haven’t been peer reviewed, have concluded that the drug isn’t efficacious against COVID-19 infections, including one conducted at Veterans Health Administration hospitals that found patients taking the drug had higher mortality rates. Then the FDA on April 24 issued a warning to health-care providers about the serious heart-rhythm problems that can occur in patients taking the drug. And Dr. Rick Bright, former director of Biomedical Advanced Research and Development Authority, has accused the administration in a whistleblower complaint of demoting him when he resisted promoting chloroquine “without transparent information on the potential health risks.”
Even the Federal Aviation Administration has warned pilots that they can’t fly while taking the drugs or for 48 hours after the last dose, citing “the known risks of these medications, such as cardiac rhythm disturbances and hypoglycemia” against unproven benefits.
Among clinicians, however, it has been one of the few tools available to treat patients hospitalized with COVID-19, at least until Gilead Sciences Inc.’s GILD, -1.48% remdesivir received an emergency-use authorization earlier this month. Many frontline clinicians are using a range of therapies, including zinc, azithromycin, hydroxychloroquine, and some HIV and anti-inflammatory arthritis drugs. Plus, hydroxychloroquine and chloroquine have proven safety profiles, are cheap to make and are readily available.
“The choice to use these drugs has already been made, probably in hundreds of thousands of patients, but with scant evidence about the risks and benefits,” researchers wrote in a New England Journal of Medicine editorial about hydroxychloroquine and chloroquine.
Raymond James analyst Steven Seedhouse, who said he still sees the potential in hydroxychloroquine, wrote in a May 7 note to investors that the study preprints, including the VA research, “collectively paint a jumbled picture” of hydroxychloroquine, and he believes the drug may reduce mortality by targeting antiviral activity that can’t be picked up by a traditional diagnostic test.
This may be why clinical trials testing hydroxychloroquine as a possible COVID-19 treatment or prophylactic are moving forward.
The World Health Organization plans to study hydroxychloroquine and chloroquine in 20,000 frontline health-care workers, as will a trial funded by the COVID-19 Therapeutics Accelerator, which is backed by the Bill and Melinda Gates Foundation, among others.
The National Institute of Allergy and Infectious Diseases said last week it is testing hydroxychloroquine and the antibiotic azithromycin in 2,000 patients with mild and moderate cases of COVID-19 to see if the drug can reduce the need for hospitalizations and prevent death. The University of Minnesota began trialing hydroxychloroquine in health-care workers reporting pre- and post-exposure to the novel coronavirus in early April. A University of Chicago study aims to see if the drug can slow the progression of the disease and keep patients out of the hospital, and the Baylor Research Institute wants to see if hydroxychloroquine can prevent infections among health-care workers in high-risk settings.
“From the existing data, which need validation in a trial, it looks like hydroxychloroquine could be a good agent for prophylaxis,” Trevor Mundel, president of the Gates Foundation’s global health program, wrote on the accelerator’s website. “It actually blocks the entry of the virus into the cell, so the hypothesis makes a lot of sense: if you have the drug in your system and you get exposed, you won’t let the virus get into your cells and you won’t get onset of disease.”