By Marcia Frellick
The Lancet today announced the retraction of a highly cited study that suggested hydroxychloroquine may cause more harm than good in patients with COVID-19. Hours later, the New England Journal of Medicine announced the retraction of a second article by some of the same authors on heart disease and COVID-19.
The Lancet article “Hydroxychloroquine or chloroquine with or without a macrolide for the treatment of COVID-19: a multinational registry analysis” was originally published online on May 22. The NEJM article “Cardiovascular disease, pharmacotherapy, and mortality in COVID-19” was initially published on May 1.
The authors of The Lancet article, Dr. Mandeep R. Mehra, Dr. Frank Ruschitzka and Dr. Amit N. Patel of Brigham and Women's Hospital in Boston, USA, wrote a letter explaining the retraction after concerns arose about the integrity of the data and how the analysis was conducted by Chicago-based Surgisphere Corp. , and the study's co-author, Dr. Sapan Desai, founder and first CEO of Surgisphere Corp.
The authors requested an independent review from Surgisphere Corp. to assess the integrity of the study elements and replicate the analyses in the article.
"Our independent reviewers informed us that Surgisphere Corp. will not transfer the complete dataset, customer contracts, and full ISO audit report to its servers for analysis because such a transfer would violate customer agreements and confidentiality requirements," the authors write.
Therefore, the reviewers were unable to perform the review and notified the authors that they would be withdrawing from the peer review process.
The Lancet said in a statement: “ The Lancet takes issues of scientific integrity very seriously, and there are many unanswered questions about Surgisphere Corp. and the data allegedly included in this study. Following the guidelines of the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE), institutional reviews of Surgisphere Corp. ’s research collaborations are urgently needed.”
The authors write: “We can never forget our responsibility as researchers to scrupulously ensure that we rely on data sources that meet the highest standards. Based on this situation, we can no longer vouch for the accuracy of the primary data sources. Due to this regrettable situation, the authors request that the article be retracted.”
"We all participated in this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologize to you, the editors and readers of the magazine for any embarrassment or inconvenience this may have caused."
In a similar, though briefer, note, the authors requested that the New England Journal of Medicine also retract the earlier article. The retraction notice on the website states: “Because not all authors were granted access to the raw data and the raw data could not be made available to an external auditor, we cannot validate the primary data sources underlying our article ‘Cardiovascular Disease, Drug Therapy, and Mortality in COVID-19.’”
"Therefore, we request that the article be retracted. We apologize to the editors and readers of the magazine for the difficulties this has caused."
As Medscape Medical News reported yesterday, both journals had already published "Expression of Concern" notices about the articles.
The editors of The Lancet stated that "important scientific questions have been raised" about the data reported in that paper. The expression of concern followed an open letter , endorsed by more than 200 scientists, ethicists, and physicians and published on May 28, questioning the study's data and ethics, as reported by Medscape Medical News.