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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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 More than a dozen hydroxychloroquine or chloroquine trials on ClinicalTrials.gov have been suspended, terminated or withdrawn.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 authors cited concerns about the veracity of data used in their analysis. The study, published last month, led the WHO to halt enrollment into the hydroxychloroquine arm of a clinical trial, while the French government revoked its authorization of the drug.
A randomized, placebo-controlled trial published in NEJM found the malaria drug was not effective as a post-exposure prophylaxis against coronavirus disease. However, questions have arisen about data used in a large observational study about the drug published last month.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
According to a news report, the decision comes after French health authorities warned against the drug's use. Meanwhile, the WHO suspended clinical testing of the drug after a paper in The Lancet raised concerns over safety and lack of efficacy.
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.
The Associated Press nevertheless reported that fewer patients were using hydroxychloroquine than before. Meanwhile, two large studies from hospitals in the New York City area indicated that the drug did not improve rates of mortality among hospitalized patients.
The study, published Thursday in the New England Journal of Medicine, included 1,376 patients at a hospital in New York. However, it was an observational study rather than a randomized, controlled one.
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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.
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.
A preprint retrospective analysis among 368 patients hospitalized with Covid-19 in the VA system found no benefit and a higher degree of death from hydroxychloroquine. A panel of experts also recommended against using the drug with azithromycin outside of trials due to potential toxicity.
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."