A Risky Move
The FDA approved use of two drugs for Covid-19 with little evidence that they work
In a letter on Saturday, the U.S. Food and Drug Administration authorized the emergency use of the antimalarial drugs hydroxychloroquine and chloroquine to treat people in the United States with the coronavirus. But the letter made clear that these drugs “are not FDA-approved for treatment of Covid-19” — they were only being made available due to the extreme circumstances.
As the Washington Post put it, “With no established treatments available, the FDA said… essentially, trying the antimalarial drugs was worth a shot.”
There isn’t much published evidence on the usefulness of these drugs to treat Covid-19, and the few studies that have been done have been criticized for having small sample sizes and less-than-rigorous methodology. Even the FDA described the data as “limited” and “anecdotal” in its letter and encouraged “conduct and participation in randomized controlled clinical trials that may produce evidence” that the drugs were useful.
Hydroxychloroquine and chloroquine were the reason for an awkward butting of heads last week between President Donald Trump and Dr. Anthony Fauci, the U.S. coronavirus lead. When Trump hailed the “very, very encouraging early results” of chloroquine treatment, Fauci quickly doubled down on the need for thorough testing and called the existing evidence “anecdotal.”
Scientists told the Washington Post that the FDA’s loose standards were cause for concern. “You need a degree of scientific evidence. It’s in the guidance. You can’t just bless it,’’ said physician Lewis Schrager, who previously worked as a medical reviewer with the FDA.
But pressure to find a treatment is mounting as Covid-19 threatens both patients and health care workers around the world. The World Health Organization is organizing a massive global trial called Solidarity that will test these antimalarial drugs as well as other compounds, but that work will take time. The first patients, in Norway and Spain, were only announced on Friday.