The World Health Organization announced Monday a "temporary pause" on the inclusion of an anti-malarial drug, which President Donald Trump said he used to help stave off coronavirus, in a global study on potential treatments for the disease.
WHO director-general Tedros Adhanom Ghebreyesus said in a news conference that the executive group overseeing the organization's "Solidarity" trial of experimental treatments decided Saturday to suspend the use hydroxychloroquine in light a study published in The Lancet that found a lower survival rate among hospitalized COVID-19 patients using the drug.
The trial's steering committee will use the pause to allow the Data Safety Monitoring Board to conduct a review and appraisal of "all evidence available globally" to "adequately evaluate the potential benefits and harms from this drug," Tedros said.
Hydroxychloroquine was one of four drugs and drug combinations included in the Solidarity trial, which has enrolled more than 3,500 patients in 17 countries, according to Tedros. Other potential treatments, including the experimental drug remdesivir and an HIV combination therapy, are still being tested.
"We want to use hydroxychloroquine if it is safe and efficacious, if it reduces mortality, reduces the length of hospitalization, without increasing the adverse events," said Dr. Soumya Swaminathan, WHO's chief scientist. Swaminathan said she expected the Solidarity trial's steering committee to review the Data Safety Monitoring Board's findings within the next two weeks.
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Dr. Michael Ryan, WHO’s emergencies chief, said the pause was "standard practice" and that if the review does not find any problems, the use of the drug in the solidarity trial would resume.
"This has purely been done as a precaution in order to be able to have that data reviewed and have the proper process," Ryan said.
Hydroxychloroquine and chloroquine are approved for treating lupus and rheumatoid arthritis and for preventing and treating malaria, but no large rigorous tests have found them safe or effective for preventing or treating COVID-19.
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The U.S. Food and Drug Administration cautioned in April that the drug has "not been shown to be safe and effective for treating or preventing COVID-19" and that it should not be used "outside of the hospital setting or a clinical trial due to risk of heart rhythm problems."
Despite the lack of evidence that it worked and the FDA's warning, Trump has repeatedly endorsed the use of the drug, saying he had a "feeling" it was effective and telling Americans, "What do you have to lose? Take it."
The president told reporters on May 18 that he had been taking the drug as a prophylactic to prevent infection. In an interview that aired Sunday, he said he "just finished" his hydroxychloroquine regimen.
"And by the way, I'm still here. To the best of my knowledge, here I am," Trump said on Sinclair Broadcast's program "Full Measure With Sharyl Attkisson."
Trump has fiercely criticized the WHO's handling of the coronavirus pandemic, accusing of acting too slowly and too willing to accept China's initial denial that there was no evidence of human-to-human transmission. He has temporarily frozen U.S. funding of the organization and threatened to make it permanent by pulling out of the United Health agency entirely.
WHO has disputed Trump's allegation that it should have sounded the alarm on the outbreak sooner. Tedros has vowed to have an independent review of the organization's response "at the earliest appropriate moment."
Contributing: Kim Hjelmgaard and Courtney Subramanian, USA TODAY; The Associated Press