Scientists are raising questions about a study that linked
The study, published last week in The Lancet medical journal, found high rates of dangerous
Backed by U.S. President
Not long after The Lancet study was published, the World Health Organization
French drugmaker Sanofi said Friday that it was halting patient recruitment in its trials of hydroxychloroquine for treating Covid. The company also said it will stop releasing the drug for off-label use in Covid-19 “until current safety concerns are cleared by WHO.”
Researchers have said that hydroxychloroquine and chloroquine need to be tested against the coronavirus in randomized clinical trials before they can be recommended. Only Gilead Sciences Inc.’s remdesivir has been shown to benefit patients by this measure.
The Lancet study, led by Mandeep Mehra of Brigham and Women’s Hospital in Boston, looked at the medical records of 96,000 coronavirus patients around the world, about 15,000 of whom were treated with antimalarials. Some of the patients also received antibiotics that are thought to enhance the benefit of the antimalarial drugs.
The letter pointed out 14 major shortcomings in the paper, including that computer code used to analyze the data wasn’t made public, and that no information was included on the medical centers that contributed data. It also said that rates of deaths reported from Africa seemed “unlikely,” that the daily doses purportedly received by some U.S. patients appeared higher than recommended, and that the level of chloroquine use in some continents was “implausible.”
The letter called on the U.S. company holding the data for the study, Chicago-based Surgisphere, to provide greater detail, and for an independent evaluation of the analysis. When scientists asked to see more of the data, according to the letter, Mehra replied that the authors weren’t able to share it under agreements with countries, governments and hospitals.
Surgisphere addressed the building controversy in a statement on its website before the scientists sent their letter Thursday. The company said it works with top-tier institutions “that have a tertiary care level of practice and provide quality healthcare that is relatively homogenous around the world. As with most corporations, the access to individual hospital data is strictly governed.”
The Lancet, in a post on Twitter, said it had made corrections to the study but that its results and conclusions remained unchanged. The corrections included how patients were counted from different regions, and the journal said that an incorrect appendix table had been included.
“There have been no changes to the finding of the paper,” according to the post.
(Updates with Lancet comment in final two paragraphs)
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