the staff of the Ridgewood blog
Washington DC, 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The often “media” quoted study on the effects of hydroxychloroquine on COVID-19 patients was retracted from a leading medical journal Thursday after doctors and scientists raised questions about the validity of the data.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 originally 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 study published on May 22 in The Lancet presented analysis of clinical data for nearly 100,000 COVID-19 patients that aimed to characterize the effects of treatment using hydroxychloroquine. The study was conducted retrospectively—as opposed to the gold standard, a placebo-controlled, randomized clinical trial (RCT)—but including data from nearly 100,000 patients lended the study credibility. The study found no evidence that hydroxychloroquine provided treatment benefit, and rather, the researchers observed significantly elevated mortality in patients treated with the drug. Following the study’s release and subsequent media attention, a number of scientists have raised concerns about the study’s design, analysis, and conclusions, including the role of various potential confounding factors. The authors indicate that they are unable to publicly share the data, so it is difficult to determine the underlying drivers of some of the findings.
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.
The authors published an erratum to the original journal article to correct a data classification error; however, the change did not alter any of their findings. Subsequent to the erratum, a group of scientists published an open letter to the study authors and The Lancet that highlights their concerns and requests details regarding the data provenance as well as an independent review of the data and analysis. The company controlling the data published a response, but it does not appear to address or commit to address any of the identified concerns.
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.”
