White House trade adviser Peter Navarro criticized the Food and Drug Administration’s decision to revoke emergency use authorization for the controversial drug hydroxychloroquine for treating the coronavirus after a study showed the possible benefits of the drug.
“The FDA decisions that they made, which I think were precipitous and based on bad science, had a tremendously negative effect on two things,” Navarro told reporters Tuesday, adding that people can no longer take the drug as a prophylactic and that hospitals cannot recruit subjects for clinical trials to test for the drug’s safety and efficacy.
Navarro referred to a study published last week by a team at the Henry Ford Health System in southeast Michigan that found the drugs “have an important role to play in reducing COVID-19 mortality.” Researchers reported that 26% of patients not given hydroxychloroquine died, compared with 13% of those who received the drug. The Henry Ford Health System team is now pushing for emergency use authorization from the FDA.
“Treatment with hydroxychloroquine alone and in combination with [the antibiotic] azithromycin was associated with reduction in COVID-19-associated mortality. Prospective trials are needed to examine this impact,” the researchers said.
The team’s conclusion runs counter to that of several recent studies showing that hydroxychloroquine is not an effective therapy for the coronavirus and could cause adverse effects to the cardiac system. The FDA revoked emergency use authorization for doctors in hospital settings to give the drug to COVID-19 patients based on mounting evidence that it is not an effective treatment. Navarro, however, said on Tuesday that the FDA’s decision to pull the emergency use authorization based on those studies was ill-advised.
President Trump has championed the promise of hydroxychloroquine as a treatment for COVID-19 despite early doubts that the anti-malarial drugs could help patients recover faster or prevent healthy people from getting the coronavirus. Navarro said that if the findings from the Henry Ford Health System are corroborated, it’ll prove that Trump “was absolutely right that hydroxychloroquine saves lives.”
Dr. Marcus Zervos, division head of infectious disease at the Henry Ford Health System and co-author of the study, cautioned that the results should be taken with a grain of salt. The drug should only be administered in a hospital, and more clinical evidence is needed to back up the team’s findings, he said.
“Currently, the drug should be used only in hospitalized patients with appropriate monitoring and as part of study protocols, in accordance with all relevant federal regulations,” Zervos said.
Whether the FDA chooses to reinstate emergency use authorization for the drug following the Henry Ford Health System report will be a test of Commissioner Stephen Hahn’s promises that the FDA’s decisions are driven purely by science. The FDA was scrutinized early on for granting emergency use authorization for the drug to be used in hospital settings without clinical proof showing its efficacy after Trump touted its benefits and even admitted to taking it himself.