A massive study that raised health concerns over hydroxychloroquine, the anti-malaria drug touted by President Trump as a coronavirus treatment, is coming under scrutiny from scientists who are demanding to see the data behind it.
The scientists expressed concerns over a high-profile study from The Lancet, which surveyed 96,000 hospitalized COVID-19 patients across six continents and concluded that the drug was ineffective in fighting the coronavirus and caused serious heart problems and even death for patients who had the disease.
An open letter from more than 180 scientists around the world raised concerns over what they said was inconsistent data in the report, noting that the average daily doses of hydroxychloroquine were higher than the those recommended by the U.S. Food and Drug Administration (FDA).
They also pointed out that data the magazine said was from Australian
patients did not seem to match data from the Australian government,
among other things.
Another major concern was that the study’s authors did not release their code or data despite signing a pledge to share information on the coronavirus.
The report “has led many researchers around the world to scrutinize in detail the publication in question. This scrutiny has raised both methodological and data integrity concerns,” the scientists wrote, adding that they were asking the Lancet to make available the peer review process that “led to this manuscript being accepted for publication.”
The report’s research team corrected some of its data Friday but maintained its conclusions had not changed.
The report in the Lancet was one of several that linked hydroxychloroquine to cardiac issues, but it was the first to link it with a higher rate of deaths. The study found that hospitalized patients who were given hydroxychloroquine were at least 33 percent more likely to die than patients who did not receive the drug.
Two major clinical trials of hydroxychloroquine were put on hold as a
result of the study, and the governments of France, Belgium and Italy
banned doctors from using it as a coronavirus treatment.
“Many of us in the scientific community were just very angry at seeing a poorly written and executed study published in The Lancet, given loads of publicity, and then having a hugely negative impact on carefully planned clinical trials around the world,” said James Watson, a Thailand-based statistician with the University of Oxford’s Centre for Tropical Medicine and Global Health who helped draft the letter, in an email to BuzzFeed News.
The Lancet spokeswoman Jessica Kleyn told the outlet that the journal will make available the responses to the study, as well as a statement from the authors.
https://thehill.com/policy/healthcare/500236-massive-hydroxychloroquine-study-raising-health-concerns-about-the-drug
The scientists expressed concerns over a high-profile study from The Lancet, which surveyed 96,000 hospitalized COVID-19 patients across six continents and concluded that the drug was ineffective in fighting the coronavirus and caused serious heart problems and even death for patients who had the disease.
An open letter from more than 180 scientists around the world raised concerns over what they said was inconsistent data in the report, noting that the average daily doses of hydroxychloroquine were higher than the those recommended by the U.S. Food and Drug Administration (FDA).
Another major concern was that the study’s authors did not release their code or data despite signing a pledge to share information on the coronavirus.
The report “has led many researchers around the world to scrutinize in detail the publication in question. This scrutiny has raised both methodological and data integrity concerns,” the scientists wrote, adding that they were asking the Lancet to make available the peer review process that “led to this manuscript being accepted for publication.”
The report’s research team corrected some of its data Friday but maintained its conclusions had not changed.
The report in the Lancet was one of several that linked hydroxychloroquine to cardiac issues, but it was the first to link it with a higher rate of deaths. The study found that hospitalized patients who were given hydroxychloroquine were at least 33 percent more likely to die than patients who did not receive the drug.
“Many of us in the scientific community were just very angry at seeing a poorly written and executed study published in The Lancet, given loads of publicity, and then having a hugely negative impact on carefully planned clinical trials around the world,” said James Watson, a Thailand-based statistician with the University of Oxford’s Centre for Tropical Medicine and Global Health who helped draft the letter, in an email to BuzzFeed News.
The Lancet spokeswoman Jessica Kleyn told the outlet that the journal will make available the responses to the study, as well as a statement from the authors.
https://thehill.com/policy/healthcare/500236-massive-hydroxychloroquine-study-raising-health-concerns-about-the-drug
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