Results are in: Miracle drug is useless

The hype over the drug hydroxychloroquine was fueled by President Donald Trump and Fox News, whose hosts touted it repeatedly on air. The president’s claims were not backed by scientific evidence, but he was enthusiastic. “What do you have to lose?” he has asked. In desperation, the public snapped up pills and the Food and Drug Administration issued an emergency use authorization on March 28 for the drug to be given to hospitalized patients. On Thursday, Trump declared, “So we have had some great response, in terms of doctors writing letters and people calling on the hydroxychloroquine.”

Now comes the evidence. Two large studies of hospitalized patients in New York City have found the drug was essentially useless against the virus.

One study, by Eli S. Rosenberg and colleagues, published in the Journal of the American Medical Association, examined 1,438 patients suffering from infection across 25 hospitals in the New York area between March 15 and 28. The study also looked at those who received hydroxychloroquine along with the antibiotic azithromycin. Trump had heralded the combination as “a real chance to be one of the biggest game changers in the history of medicine.” The conclusion of the study: “Among patients hospitalized in metropolitan New York with COVID-19, treatment with hydroxychloroquine, azithromycin, or both, compared with neither treatment, was not significantly associated with differences in in-hospital mortality.”

The second study, by Joshua Geleris and colleagues, examined 1,376 patients at New York-Presbyterian Hospital-Columbia University Irving Medical Center in northern Manhattan from March 7 to April 8. Their conclusion in the New England Journal of Medicine: “In this analysis involving a large sample of consecutive patients who had been hospitalized with Covid-19, the risk of intubation or death was not significantly higher or lower among patients who received hydroxychloroquine than among those who did not.” The results, they said, “do not support the use of hydroxychloroquine at present” except in clinical trials.

The two studies were observational.

Separate, controlled clinical trials are underway, including one sponsored by the National Institutes of Health. But both of these hospital studies examined a group of patients significantly larger than the tiny, initial research by the maverick doctor Didier Raoult in Marseille, France, that triggered the frenzy. If the drug had any effectiveness against the coronavirus, it would probably have shown some positive results among more than 2,800 hospitalized patients in New York. It did not.

After Trump promoted the drug, it went into shortage for those who take it for approved uses, such as combating lupus, rheumatoid arthritis and other autoimmune diseases. On April 24, the FDA cautioned against use of the drug for coronavirus patients outside closely supervised hospital settings, pointing to known side affects such as heart trouble. The FDA should now revoke the emergency use authorization, especially if the clinical trials confirm what the two hospital studies have shown.

In a crisis, all possibilities must be investigated. But evidence is mounting that hydroxychloroquine was a dud.