‘We can no longer vouch for the veracity of the primary data sources.’

Authors of a Lancet study on hydroxychloroquine treatment of COVID-19 have retracted their findings, as WHO announces it will resume its trial

A study published in The Lancet has been retracted after several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder, Sapan Desai, a co-author on the paper.

The large observational study published on 22 May had originally linked hydroxychloroquine and chloroquine use to increased rates of mortality and heart arrhythmias in hospitalised COVID-19 patients.

However the three remaining co-authors, Mandeep Mehra, Frank Ruschitzka and Amit Patel, submitted the retraction after attempts to conduct an independent third-party peer review of Surgisphere’s data failed.

Independent peer reviewers reported that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis, claiming that “such transfer would violate client agreements and confidentiality requirements”.

“Based on this development, we can no longer vouch for the veracity of the primary data sources,” the three co-authors not affiliated with Surgisphere responded.

“Due to this unfortunate development, the authors request that the paper be retracted.

“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,” they said.

“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.”

The Lancet said in a statement that it “takes issues of scientific integrity extremely seriously”.

“There are many outstanding questions about Surgisphere and the data that were allegedly included in this study,” said The Lancet.

“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.”

A second study based on Surgisphere data and published in the New England Journal of Medicine on 1 May, which evaluated the relationship between cardiovascular disease and drug therapy with in-hospital death among hospitalised COVID-19 patients, has also been retracted.

“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’,” wrote co-authors Mandeep Mehra, Sapan Desai, SreyRam Kuy, Timothy Henry and Amit Patel.

“We therefore request that the article be retracted. We apologise to the editors and to readers of the Journal for the difficulties that this has caused.”

Letters signed by over one hundred doctors, pharmacists, researchers, epidemiologists and statisticians from across the world were sent to both The Lancet and the NEJM regarding shared methodological and data integrity concerns about the papers.

Signatories called for provision of details on data provenance, sharing of aggregated patient data at the hospital level, independent validation of the analysis, and open access to all the data sharing agreements cited.

They noted that the results of the Lancet study have had “a considerable impact on public health practice and research”, with several clinical trials – including one being run by the World Health Organization – temporarily suspending their hydroxychloroquine arms based on the research findings, and some countries suspending use among citizens outside of clinical trials.

However the WHO has now announced that on the basis of the available mortality data, the members of its data safety and monitoring committee have recommended that the hydroxychloroquine arm of the trial can continue.

On publication of the initial study, the Department of Health said it would be updating its advice that hydroxychloroquine use in treating COVID-19 is strongly discouraged including in hospitalised patients unless the patient is enrolled in a clinical trial.

A spokesperson from the TGA told AJP on Wednesday that they are closely monitoring developments following the retraction of the Lancet article.

“The evidence for the safety and effectiveness of hydroxychloroquine to treat or prevent COVID-19 remains limited and therefore off-label use for this purpose continues to be discouraged other than in a clinical trial setting,” they said.

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