Update: On June 4, the study was retracted from The Lancet due to serious concerns over its data. Read our new story about the study’s retraction here.
The malaria drug that President Donald Trump has said he is taking as a coronavirus preventive, hydroxychloroquine, was linked to a higher rate of deaths and serious heart problems, according to a massive study of COVID-19 hospital patients released Friday.
The drug, also used to treat arthritis and lupus, has emerged as a medical flashpoint in the coronavirus pandemic, seeing the FDA issue a warning against its use outside of hospitals even as Trump said he was taking it.
The six-continent report released by the Lancet journal effectively slams the door on the suggestion that hydroxychloroquine helps COVID-19 patients, showing no signs of benefit among the 96,000 patients in the study.
Instead, it found the drug linked to an increased risk of dying — by over 35% — while also more than doubling the risk of heart arrhythmia.
"It's no longer that hydroxychloroquine has no sign of efficacy — it is associated with an increase in mortality," said cardiologist Eric Topol of the Scripps Research Institute in a tweet on the study.
“It’s one thing not to have benefit, but this shows distinct harm,” Topol told the Washington Post. “If there was ever hope for this drug, this is the death of it.”
To generate its statistical power, the study tallied the experience of nearly 15,000 hospital patients taking some combination of hydroxychloroquine drugs against more than 80,000 who didn't. More than 10,000 patients among the 96,000 in the study died.
Patients given a combination of hydroxychloroquine or chloroquine, taken with or without an antibiotic as some regimens suggested, died at a higher rate compared to the patients who didn't get the drug.
"Our findings suggest not only an absence of therapeutic benefit but also potential harm with the use of hydroxychloroquine or chloroquine drug regimens," concluded the study.
It's possible that the heart arrhythmias documented in the study aren't what killed the patients, noted a commentary led by Christian Funck-Brentano of France's Sorbonne University that the journal ran with the study. Instead, those might be due to a separate problem for people already on heart drugs, and hydroxychloroquine drugs, they suggested, simply "could worsen COVID-19 severity in some patients."