Editors warn that 'serious scientific questions' have been raised about a massive study of whether a common malaria pill can help treat coronavirus

U.S. President Donald.Reuters
  • The editors of The Lancet on Tuesday issued an "Expression of Concern" about a study on the use of the antimalarial medication hydroxychloroquine in coronavirus patients, saying that serious scientific questions have been raised about it.
  • Initially published May 22, the study found that hydroxychloroquine and chloroquine did not appear to benefit coronavirus patients who took them. Instead, the study concluded, those who received one of the medications had a higher risk of death than those who did not take them.
  • In the weeks since, scientists have been raising questions about the paper's statistical analysis and integrity of the data.
  • Hydroxychloroquine and chloroquine got attention early in the pandemic as a potential treatment for COVID-19, the disease caused by the novel coronavirus. The drugs are approved for other uses but not for the treatment of COVID-19.

The editors of the journal that in May published a massive observational study on the use of antimalarial medications for the treatment of hospitalized coronavirus patients on Tuesday issued an "Expression of Concern" after scientists raised questions about the data included and how it was analyzed.

In May, The Lancet published a massive study finding that the treatments didn't appear to help patients hospitalized with the novel coronavirus and instead were associated with heart complications and an increased risk of death.

The analysis looked at the hospital outcomes of 96,032 hospitalized patients, 14,888 of whom got some form of the antimalarial treatments chloroquine and hydroxychloroquine over the course of four months.Advertisement

The patients came from 671 hospitals from six continents, and the study was led by researchers at the Brigham and Women's Hospital in Boston. Though it was not a randomized controlled trial, it's the largest study of its kind in patients with COVID-19, the disease caused by the novel coronavirus. Shortly after the data was published, the World Health Organization put a temporary pause on the hydroxychloroquine arm of a trial it's running in light of the data.

But in the weeks since the study was published, scientists have been raising questions about the paper's statistical analysis and integrity of the data, which are held by a US company called Surgisphere.

"Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention," The Lancet editors wrote Tuesday.
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The study was corrected on May 29, though its conclusions remained unchanged.

Never miss out on healthcare news. Subscribe to Dispensed, Business Insider's weekly newsletter on pharma, biotech, and healthcare. The observational study published in May examined the outcomes of patients who were treated with hydroxychloroquine, hydroxychloroquine and a macrolide antibiotic, chloroquine, or chloroquine and a macrolide antibiotic. Macrolides are a type of antibiotic that includes azithromycin.Advertisement

Ultimately the authors couldn't find a benefit in those who were given the treatments compared with those who didn't receive any of the combinations. Instead, the study found an increased frequency in abnormal heartbeats in those who received the medications. Those who received the medications had a higher risk of death compared with those who did not take the medications.

To be sure, there are limits to the analysis. It was observational in nature, though randomized controlled trials — which preemptively assign patients either to the medication or a placebo control at random — are underway.

Read more: Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemicAdvertisement

Dr. Robin Armstrong holds a bottle of hydroxychloroquine.AP Photo/David J. Phillip

Early in the pandemic, the drug caught the eyes of doctors, experts, and the Trump administration as a potential coronavirus treatment. Some early, promising results regarding the drug were published in late March.

President Donald Trump on May 18 said he had been taking hydroxychloroquine every day for a week and a half. Advertisement

Additional studies, however, have cast doubt on how effective the drug might be in treating the novel coronavirus. A clinical trial taking place in Brazil was halted in April after a spike in deaths among patients who had received the drug.

The drug has not been approved by the US Food and Drug Administration for the treatment of COVID-19.

Two observational studies, published in the New England Journal of Medicine and the Journal of the American Medical Association, found that among thousands of hospitalized coronavirus patients, those who received the antimalarial medication hydroxychloroquine didn't fare better or worse than patients who didn't receive the drug. Advertisement

Read more: Morgan Stanley analyzed every potential coronavirus vaccine to create a list of the 6 most promising shots that will be ready first

This article was initially published on May 22 and has been updated to reflect the concern raised by the editors of The Lancet on June 2. Read the original article on Business Insider
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