(p. A11) A group of scientists who raised questions last week about a study in The Lancet about the use of antimalarial drugs in coronavirus patients have now objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry.
Moments after their open letter was posted online Tuesday morning [June 2, 2020], the editors of the N.E.J.M. posted an “expression of concern” about the paper, and said they had asked the paper’s authors to provide evidence that the data are reliable.
The Lancet followed later in the day with a statement about its own concerns regarding the malarial drugs paper, saying that the editors have commissioned an independent audit of the data.
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In their letter to the N.E.J.M., critics of the work wrote: “Serious, and as yet unanswered, concerns have been raised about the integrity and provenance of these data.”
The letter points out “major inconsistencies” between the number of coronavirus cases recorded in some countries during the study period and the number of patient outcomes reported by the researchers over the same period.
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Many of the scientists who first raised concerns about the database are involved in clinical trials of chloroquine and hydroxychloroquine, and they were forced to pause the studies for safety reviews after The Lancet study was published.
James Watson, a senior scientist with MORU Tropical Health Network, said his unit had to immediately suspend work on a large randomized clinical trial to see if chloroquine or hydroxychloroquine can protect health care workers exposed on the job to the coronavirus from infection.
“I saw very quickly this paper didn’t hold up to much scrutiny at all,” he said. “We started wondering, ‘Who’s been collecting this data, and where did it come from?’ We were quite surprised to see a global study with only four authors listed and no acknowledgment of anyone else.”
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David Glidden, a professor of biostatistics at University of California, San Francisco, who reads all new publications about Covid-19 antiviral therapies as a member of a National Institutes of Health clinical guidelines panel, said he was immediately struck by the vagueness of the descriptions in both papers.
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(Note: the online version of the article was updated June 2, 2020, and had the title “Scientists Question Medical Data Used in Second Coronavirus Study.”)