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(With inputs from Dr Monica Vasudev)
939: Two Journals Retract Studies on HCQ, Heart Disease in COVID-19
MEDSCAPE: The Lancet announced that it has retracted a highly cited study that indicated that hydroxychloroquine may cause more harm than benefit in patients with COVID-19.
Soon, the New England Journal of Medicine also announced that it has retracted an article by some of the same authors, also on heart disease and COVID-19.
The Lancet article, "Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis" was published online May 22. The NEJM article, "Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19" was published May 1.
Three authors of The Lancet article, Mandeep R. Mehra, MD, Frank Ruschitzka, MD, and Amit N. Patel, MD, of Brigham and Womens Hospital in Boston, Massachusetts, wrote in a letter that the action followed concerns regarding the integrity of the data, and about how the analysis was performed by Chicago-based Surgisphere Corp and study coauthor Sapan Desai, MD, Surgispheres founder and CEO.
The authors seek an independent third-party review of Surgisphere to determine the integrity of the trial elements and to replicate the analyses in the article.
Authors stated that their independent peer reviewers have informed that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, as it violates client agreements and confidentiality requirements.
Reviewers were thus not able to conduct the review and notified the authors that they would withdraw from the peer-review process.
The Lancet released the following statement: "The Lancet 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. Following guidelines from the Committee on Publication Ethics (COPE) and International Committee of Medical Journal Editors (ICMJE), institutional reviews of Surgispheres research collaborations are urgently needed."
The authors write, "We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.”
"We all entered 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 the journal readership for any embarrassment or inconvenience that this may have caused."
In a similar, note, the authors requested that the New England Journal of Medicine retract the earlier article as well. The retraction notice on the website reads: "Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. "We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused."
The expression of concern followed an open letter, endorsed by over 200 scientists, ethicists, and clinicians and posted on May 28, questioning the data and ethics of the study.
New Eng J Med. Published online June 4, 2020. Retraction; The Lancet. Published online June 4, 2020. Retraction
WHO Set to Resume Hydroxychloroquine Trial
The WHO is going to resume its trial of hydroxychloroquine (HCQ) for the treatment of patients with COVID-19.
The agency had briefly interrupted giving it to newly enrolled patients over health concerns following a report that the drug might increase the risk for death and irregular heartbeats.
In the interim, the study was continued with other medicines. WHOs Director-General, Tedros Adhanom Ghebreyesus, said its experts had advised the continuation of all trials including hydroxychloroquine.
WHO aims to run clinical tests of potential COVID-19 treatments on nearly 3500 patients in 35 countries.
Dr KK Aggarwal