WHO Suspends Trial of Trump-Touted COVID-19 Treatment Hydroxychloroquine Due to Safety Concerns
A pharmacy tech pours out pills of hydroxychloroquine at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020. GEORGE FREY / AFP via Getty Images
Citing safety concerns, the World Health Organization (WHO) said Monday it was suspending its trial of hydroxychloroquine, an anti-malarial drug that has been championed by President Donald Trump as a treatment for the new coronavirus.
The WHO decision followed the release of a Lancet study Friday that found that COVID-19 patients who took the drug were more likely to die or develop heart problems.
“The steering committee met over the weekend, in the light of this uncertainty,” WHO chief scientist Soumya Swaminathan told NPR. “We decided we should be proactive, err on the side of caution and suspend enrollment temporarily into the hydroxychloroquine arm [of the Solidarity trial].”
Study finds use of chloroquine or #hydroxychloroquine with or without a macrolide is linked to increased rates of mortality and heart arrhythmias among hospital patients with #COVID19 (2/4) pic.twitter.com/AYY5MM2nKL
— The Lancet (@TheLancet) May 22, 2020
The WHO Solidarity Trial is an effort to test the effectiveness of potential COVID-19 treatments, including hydroxychloroquine, remdesivir and an HIV combination therapy, The Guardian reported. It involves 3,500 patients from 17 countries randomly assigned one of four experimental treatments, according to NPR.
Unlike the WHO trial, the Lancet study was based on observation rather than a controlled experiment. However, the number of people in the study — 96,000 — raised concerns, Swaminathan explained to NPR.
Of the 96,000 in the Lancet study, nearly 15,000 were given hydroxychloroquine or chloroquine, with or without an antibiotic, BBC News reported. The death rate for patients treated with hydroxychloroquine was double the control, at 18 percent compared to nine percent. The death rate for patients treated with chloroquine was 16.4 percent.
In light of these findings, the Executive Group of the Solidarity Trial met Saturday and agreed to a temporary pause of WHO’s hydroxychloroquine trial, WHO Director-General Tedros Adhanom Ghebreyesus told reporters Monday.
“The review will consider data collected so far in the Solidarity Trial and, in particular robust randomised available data, to adequately evaluate the potential benefits and harms from this drug,” he said.
"The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the data is reviewed by the Data Safety Monitoring Board"-@DrTedros #COVID19
— World Health Organization (WHO) (@WHO) May 25, 2020
Swaminathan told NPR that WHO would decide whether to resume the hydroxychloroquine tests in a week or two.
In the meantime, Tedros said the other arms of the Solidarity Trial were continuing, and that concerns about hydroxychloroquine were limited to its use as a COVID-19 treatment.
“I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria,” he said.
The news came the day after Trump claimed to have “just finished” a course of hydroxychloroquine as a preventative measure against the new coronavirus in an interview aired on Sinclair Broadcasting, as CNBC reported.
“And by the way, I’m still here,” he said.
Trump first began to promote the use of hydroxychloroquine against the new coronavirus in March, but the Lancet study is not the first to question its safety as a treatment for the new disease.
HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)…..
— Donald J. Trump (@realDonaldTrump) March 21, 2020
Studies published in April found that hydroxychloroquine taken with the antibiotic azithromycin could increase the risk of heart failure, and that U.S. Veterans Health Administration patients treated with hydroxychloroquine had higher death rates than those who were not.
The WHO trial itself had not produced any data showing increased risk from hydroxychloroquine before it was suspended, Swaminathan told NPR.
The White House declined to comment to CNBC on WHO’s decision to suspend the trial, and the Department of Health and Human Services did not respond in time.
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