The Lancet withdraws controversial hydroxychloroquine study

The Lancet issued a statement Thursday saying a study that had suggested hydroxychloroquine was associated with higher rates of ventricular arrhythmia and death in COVID-19 patients -- eventually leading to several global hydroxychloroquine trials being halted as a result -- has been retracted as three of the authors "can no longer vouch for the veracity of the primary data sources." Richard Horton, the journal's editor, remarked "this is a shocking example of research misconduct in the middle of a global health emergency."

The multinational registry analysis, published in The Lancet on May 22, included nearly 15,000 people treated with hydroxychloroquine or chloroquine, either alone or along with a macrolide. The study was based on data and analyses conducted by US healthcare analytics firm Surgisphere, and its founder Sapan Desai, who was listed as the fourth co-author on the paper.

Independent audit

In a joint statement, co-authors Mandeep Mehra, Frank Ruschitzka and Amit Patel said that after several concerns were raised about the study, they commissioned an independent third-party peer review of Surgisphere, with Desai's consent, "to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper." However, they said Surgisphere refused to transfer the full dataset for analysis, claiming such a move would "violate client agreements and confidentiality requirements." As a result, the three authors have requested the retraction of the article.

The study's findings recently prompted the World Health Organization (WHO) to suspend the hydroxychloroquine arm of its own COVID-19 trial, with Belgium, France and Italy, as well as Germany, among others, following suit. The WHO trial has since resumed.

Similar retraction in NEJM

For its part, The Lancet stated Thursday that it "takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study." The journal added that "institutional reviews of Surgisphere's research collaborations are urgently needed."

Meanwhile, also on Thursday, Mehra asked the NEJM to retract another study relying on data from Surgisphere. In that article, researchers said they were unable to confirm previous concerns about a possible harmful association of either ACE inhibitors or angiotensin-receptor blockers with in-hospital deaths among hospitalised patients with COVID-19.

The editors from both journals had each recently issued an "expression of concern" for their respective studies, saying that serious scientific questions had been raised. 

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