FDA authorizes widespread use of unproven drugs to treat coronavirus

The Food and Drug Administration has given emergency approval to a Trump administration plan to distribute millions of doses of anti-malarial drugs to hospitals across the country, saying it is worth the risk of trying unproven treatments to slow the progression of the disease in seriously ill coronavirus patients.

There have only been a few, very small anecdotal studies that show a possible benefit of the drugs, hydroxychloroquine and chloroquine, to relieve the acute respiratory symptoms of Covid-19 and clear the virus from infected patients.

And health experts warn the drugs’ well-known side effects could become more commonplace with much wider use. In particular, they say, patients with existing heart problems or taking certain drugs such as anti-depressants that affect heart rhythm are at risk of a fatal episode. Experts recommend screening before the drugs are prescribed to prevent drug-related deaths.

“The concern really is if we’re talking millions of patients, then this issue of drug induced sudden cardiac death is absolutely going to rear its ugly head,” said Dr. Michael Ackerman, a pediatric cardiologist and professor at the Mayo Clinic College of Medicine and Science.

Long-term use of the drugs also is associated with a form of vision loss called retinopathy, but the use of the drugs to fight virus in an infected patient is only for a few days.

The FDA’s emergency authorization does not cover longer-term use of the drugs to prevent the coronavirus infection, a practice that has become more commonplace as doctors have prescribed the drugs “off label” in response to the pandemic.

With no established treatments available, the FDA said in an approval letter dated Saturday that, essentially, trying the anti-malarial drugs was worth a shot. It cited the actions of other countries to adopt the drugs as a coronavirus treatment and the limited laboratory tests and clinical experience that may show benefit.

“It is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating covid-19,” the FDA’s chief scientist, Denise Hinton, wrote in the letter granting emergency approval.

Novartis and Bayer are contributing millions of doses of the drugs to the federal government, which will distribute them via the Strategic National Stockpile. The extraordinary action came at the request of the Biomedical Advanced Research and Development Authority, a division of the Department of Health and Human Services.

The FDA earlier this month approved a plan to distribute hundreds of thousands of doses of the drugs to hospitals in New York, which has emerged as the epicenter of the pandemic in the United States.

Despite the lack of evidence of a benefit, President Donald Trump has repeatedly stated his belief that the drugs will work to treat coronavirus. One of his top advisers on the government response, Anthony Fauci, chief of the National Institute of Allergy and Infectious Disease, has repeatedly stated that the public should view the drugs with caution because of the paucity of evidence.

In a news release Sunday night announcing the unprecedented action, HHS Secretary Alex Azar hailed Trump for “taking every possible step to protect Americans from the coronavirus and provide them with hope.”

Azar cited the president’s “bold leadership” for making possible the donations of pills by Novartis’s generic subsidiary, Sandoz, as well as Bayer.

Many hospitals and doctors have already been prescribing the anti-malarial drugs for weeks.

The surge in demand has sapped supplies of hydroxychloroquine, which has been used to treat lupus and rheumatoid arthritis. Patients suffering from those diseases have been unable to get their prescriptions filled in some parts of the country because of the run on the drugs as well as hoarding, according to health experts.