A major study on the effects of hydroxychloroquine on COVID-19 patients was retracted from a leading medical journal Thursday after doctors and scientists raised questions about the validity of the data.
The study had concluded patients taking the anti-malaria drug had a higher risk of death than those who were not taking the medication, leading some researchers to suspend their clinical trials.
The three authors of the study, led by Mandeep R. Mehra of Harvard Medical School and published in late May, retracted their study from the Lancet because independent peer reviewers could not access the data used for the analysis.
The source of the data was Surgisphere Corporation, which told peer reviewers it would not transfer the full dataset used for the study because it would violate client agreements and confidentiality requirements.
“We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic,” the authors wrote in a statement Thursday. “We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”
The study focused on more than 96,000 hospitalized COVID-19 patients at 671 hospitals on six continents, using hospital records obtained by Surgisphere Corporation, a little-known data company, that is owned by Sapan Desai, one of the co-authors of the study. Desai did not sign on to the retraction with the other three co-authors.
The Lancet wrote in a statement that it “takes issues of scientific integrity extremely seriously” and that there are “many outstanding questions about Surgisphere and the data that were allegedly included in this study.”
The drug was repeatedly touted by President Trump as a potential treatment for COVID-19, despite limited evidence of its efficacy.
Trump took a two-week course of hydroxychloroquine after his valet driver tested positive for COVID-19. A separate study published Wednesday showed the drug is not effective at preventing COVID-19 after exposure to the virus.
A separate study of 368 patients published in the New England Journal of Medicine in April found the two primary outcomes for COVID-19 patients treated with hydroxychloroquine were death and the need for mechanical ventilation.
The analysis was conducted retrospectively, based on data from patients hospitalized with confirmed coronavirus infections in all Veterans Health Administration medical centers until April 11.
While not a rigorous trial, randomized trials of hydroxychloroquine are underway, including ones being led by the National Institutes of Health and the World Health Organization.
Updated at 4:22 p.m.