Lancet, NEJM retract controversial COVID-19 studies based on Surgisphere data

Two days after issuing expressions of concern about controversial papers on Covid-19, The Lancet and the New England Journal of Medicine have retracted the articles because a number of the authors were not granted access to the underlying data.

The Lancet paper, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis,” which relied on data from a private company called Surgisphere and had concluded that hydroxychloroquine was linked to a higher risk of death among some COVID-19 patients, has been dogged by questions since its publication in late May. Some of those complaints led to a correction about aspects of the data, but at the time the authors stood by their conclusions — namely, that hydrochloroquine and chloroquine do not to appear to be effective against the viral infection. 

That correction was followed earlier this week by the expression of concern, and now three of the four authors of the article have decided to pull it entirely. The abstaining author, Sapan Desai, is the founder of Surgisphere, whose mission statement declares that the goal of the company is to: 

relentlessly pursue advancements in machine learning, artificial intelligence, and big data with the intention of developing industry-leading tools that empower healthcare providers to make better, faster, and more accurate decisions. 

Desai, as Medscape reports, wrote two papers about research misconduct in 2011 and 2013.

The Lancet on Thursday issued a statement about the decision, noting that the retraction wasn’t unanimous: 

Today, three of the authors of the paper, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis”, have retracted their study. They were unable to complete an independent audit of the data underpinning their analysis. As a result, they have concluded that they “can no longer vouch for the veracity of the primary data sources.” 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 Surgisphere’s research collaborations are urgently needed.

The retraction notice goes into a bit more detail:

After publication of our Lancet Article, 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. We launched an independent thirdparty 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.

We always aspire to perform our research in accordance with the highest ethical and professional guidelines. We can never forget the responsibi,lity 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 apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.

*Mandeep R Mehra, Frank Ruschitzka, Amit N Patel 

The publication of the study had prompted the World Health Organization (WHO) to halt a study of hydroxychloroquine, but the WHO resumed that trial once the expression of concern appeared.

The New England Journal of Medicine retraction followed a little more than an hour later, with Desai agreeing to the move:

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.”1 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.

Updated at 2015 UTC, June 4, 2020, with news of the NEJM retraction.

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