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One of the signatories, Dr. Adrian Hernandez, who heads the Duke Clinical Research Institute, said the paper contained many troubling anomalies, “but the biggest thing that raised a red flag was that here was such a large database across more than 600 hospitals, and no one had really known about its existence. That was quite remarkable.”
Like several other signatories of the letter, Dr. Hernandez is involved in a clinical trial of hydroxychloroquine to see if it can protect health care workers from infection.
Allen Cheng, a professor of infectious diseases at Monash University in Melbourne, Australia, who also signed the letter, said in an email that the individual hospitals included in the database should be identified.
“Ideally, the database should be made public, but if that isn’t possible, it should at least be independently reviewed and an audit performed,” he said.
Surgisphere’s data was also the basis of a study of coronavirus patients published in The New England Journal of Medicine this month by some of the same authors, including Dr. Desai and Harvard’s Dr. Mehra, as well as for two versions of an article on the use of an antimicrobial drug to treat Covid-19 that were not published in an established medical journal.
Jennifer Zeis, a spokeswoman for The New England Journal of Medicine, said by email that the journal was aware of the questions that had been raised and was looking into them.
Dr. Mehra issued a statement Friday, saying that the paper’s authors “leveraged the data available through Surgisphere to provide observational guidance to inform the care of hospitalized Covid-19 patients” because the results of randomized clinical trials would not be available for some time.
Other observational studies had previously reported possible harms associated with the malaria drugs, and the Food and Drug Administration had issued a safety warning about their use. After the Lancet paper was published, the World Health Organization and other organizations suspended clinical trials of the drugs.