The authors of a controversial study concerning hydroxychloroquine (HCQ) and its use in the treatment of COVID-19 have retracted it.
“After publication…several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication,” three of the study authors – Mandeep R. Mehra, MD, MSc, Frank Ruschitzka, MD, Amit N. Patel, MD – said in their retraction. “We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.
“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process…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.”
A statement issued by The Lancet said 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. Following guidelines from the Committee on Publication Ethics (COPE) and International Committee of Medical Journal Editors (ICMJE), institutional reviews of Surgisphere’s research collaborations are urgently needed.”
The study authors, in their retraction, said “we always aspire to perform our research in accordance with the highest ethical and professional guidelines. 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…we all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”
A number of concerns were raised concerning the Lancet paper following its publication. More than 120 clinicians, medical researchers, statisticians, and ethicists worldwide signed an open letter expressing their misgivings.
The Lancet paper precipitated a decision by the World Health Organization (WHO) to suspend the use of HCQ – used as a treatment for a number of conditions such as malaria and lupus – in clinical trials pertaining to COVID-19. Institutions such as the US Food and Drug Administration have raised concerns over adverse side effects due to HCQ. However, others – notably the Indian Council of Medical Research (ICMR) – have promoted its use. The ICMR released data recently indicating the risk of infection among uninfected healthcare workers could be cut by eighty percent with the use of HCQ.