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More than 140 scientists and physicians are challenging the validity of an influential study that found an association between prescribing the antimalarial drugs hydroxychloroquine and chloroquine for COVID-19 patients and increased in-hospital mortality. After the observational study's results were published within the Lancet on May 22, the earth Health Organization (WHO) temporarily suspended enrollment into an ongoing randomized clinical trial testing hydroxychloroquine for COVID-19
An letter to the observational study's authors and therefore the Lancet's editor-in-chief posted May 28 lists 10 concerns. The signatories, who identify themselves as "clinicians, medical researchers, statisticians, and ethicists from across the earth ," say the researchers didn't account sufficiently for factors which can have influenced their results, including disease severity, and lift concerns a few lack of ethics review and errors within the underlying database
They also charge that the study's authors are being unduly secretive about their data sources and methods, despite the very fact that The Lancet signed a pledge to support data sharing during the coronavirus pandemic
"This paper has had a really negative impact on clinical trials," said Watson , DPhil, a statistician at the Mahidol-Oxford medicine Research Unit in Thailand and thus the lead signatory on the letter . "A lot of selections [about hydroxychloroquine] are made on the thought of very poor evidence. This drug might be harmful, it might be beneficial, it could do absolutely nothing in the least , but we'd like a randomized trial," Watson said
The Lancet study is based on data from the medical services company Surgisphere about 96,032 hospital patients diagnosed with COVID-19 from December 20 to Pan American Day from every continent except Antarctica. Every patient was discharged by April 21, unless that they had died by then. the bulk of patients, 81,144, didn't receive antimalarial drugs. The remaining 14,888 patients began to receive the antimalarial drugs chloroquine or hydroxychloroquine within 48 hours of their positive diagnosis, either alone or with an antibiotic
After controlling for various factors including age, race, sex, and comorbidities like cardiovascular and lung disease, the authors found that patients on antimalarials were twice as likely to die within the hospital as patients who didn't receive them (18% mortality for patients who received hydroxy chloroquine, 16.4% for chloroquine, 9.3% for those that didn't receive an antimalarial). Patients who also received antibiotics experienced even higher mortality rates
"We were fairly reassured that, although the study was observational, the signals were robust and consistent across all regions of the earth in diverse populations, which we didn't see any muting of that signal, counting on region," lead author Mandeep R. Mehra, MD, MSc, the Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women's Hospital in Boston, Massachusetts, previously told the heart.org | Medscape Cardiology about the results
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