The drug has consistently failed to show a benefit when tested in randomized, controlled clinical trials. Social science may explain why laypeople and doctors alike continue clinging to it.
The study adds to the growing body of evidence that the drug, promoted early in the pandemic by President Trump, is ineffective, despite its getting a briefly renewed lease on life earlier this month thanks to a retrospective analysis.
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The drugmaker said an "acute" recruitment challenge made it unlikely the trial would be able to collect meaningful data on efficacy. More than a dozen hydroxychloroquine or chloroquine trials on ClinicalTrials.gov have been suspended, terminated or withdrawn.
The agency said its own analysis of the EUA, issued in March, and emerging data showed the drug and a related compound, chloroquine, were unlikely to be effective. The Trump administration had aggressively promoted the drug despite a lack of supporting scientific evidence.
The study, published in The Lancet, found a possible association between hydroxychloroquine and chloroquine and heart arrhythmias and death. Meanwhile, SingleCare saw a as much as a 22% increase in scripts filled for hydroxychloroquine following Trump's remarks last week.
Bright alleges that his removal from BARDA was the culmination of tensions that had arisen starting three years ago over contracts worth millions of dollars he says were awarded on the basis of political connections and "cronyism" rather than scientific merit.
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The FDA said patients should not use the drugs outside of hospital settings or clinical trials after a review of literature and data from poison control centers and its adverse event reporting system found instances of heart arrhythmias, some of which were fatal.
Rick Bright, who had been director of the Biomedical Advanced Research and Development Authority since 2016, is now filing a whistleblower complaint, saying he was placed in a more limited position at the NIH pushing back against promotion of hydroxychloroquine.
In an opinion article in the New England Journal of Medicine, Drs. Benjamin Rome and Jerry Avorn of Harvard University wrote that advocating quick FDA approval for hydroxychloroquine and chloroquine despite paucity of evidence "runs counter to the idea of evidence-based medicine."
Two investigators in Gilead's Phase III remdesivir trials were unsurprised at recent protocol changes. However, they said enrollment in the moderate-disease study was slow due to difficulty capturing those patients, with one also citing publicity-driven interest in two unproven malaria drugs.
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While not necessarily faulting the FDA for granting a limited emergency use authorization to hydroxychloroquine and chloroquine despite little data to support their use in the pandemic disease, some interviewed experts said it risked politicizing the agency.
The agency said in a letter to the director of BARDA that the authorization was for patients unable to participate in clinical trials. However, there is scant evidence demonstrating that the drugs, hydroxychloroquine and chloroquine, are effective against Covid-19.