Lancet withdraws controversial study linking HCQ to higher Covid death risk over data issues

Three of the four authors of the study apologised to The Lancet's editors and readership for any embarrassment or inconvenience their published findings may have caused.

Representational Image | Source : John Phillps | Getty | Bloomberg

New Delhi: The Lancet, one of the world’s most prominent medical journals, Thursday retracted an important study that linked the anti-malarial drug hydroxychloroquine (HCQ) to higher risk of death and irregular heart rhythms in Covid-19 patients. 

The study, which had prompted even the World Health Organization (WHO) to pause HCQ clinical trials in Covid-19 patients last month under its giant ‘solidarity trial’, has been questioned for parsing through data in lesser-than-usual time, and has faced allegations of data fabrication too.

A second study, conducted by one of the Lancet researchers, claiming cardiovascular diseases increased chances of in-hospital Covid-19 death, has been withdrawn as well from the New England Journal of Medicine (NEJM), another highly respected medical journal for similar reasons.

The Lancet, while announcing the withdrawal of the controversial study, said, “today three of the authors have retracted the study  — Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis”.

The study was conducted by four researchers. The three researchers to retract the study include the lead author Mandeep R. Mehra, Frank Ruschitzka and Amit N. Patel. Sapan Desai, founder of Surgisphere, a Chicago-based healthcare data analytics company that supplied the data for the study, is the fourth author.  

The three authors in the retraction note have apologised to readers and editors of the journal for “any embarrassment” that the report may have caused.  

The Lancet, in a separate statement, said that the authors 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,” it said. 

The study published on 22 May raised alarm over the aggressive use of HCQ and claimed that those receiving the anti-malarial drug had an elevated risk of death and also experienced increased irregular heart rhythms, when compared to other virus patients.

The large observational study claimed to have analysed data from nearly 96,000 patients. It said that around 15,000 patients in the study either received HCQ alone or in combination with some antibiotics and were compared to the data of 81,000 controls who did not receive the drug.

Inability to verify the origin of data: Three authors

The retraction note written by the three authors says the data they received from Surgisphere did not pass an independent third-party review. “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,” the note said.  

“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.” 

However, the notice said, “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.” 

“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,” it added.

“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,” the researchers said, adding, “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.” 

They concluded the note by saying that “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 also said it takes issues of scientific integrity extremely seriously, and that there are many outstanding questions about Surgisphere and the data that was 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,” it said.

Authors retract another study published in second journal

Another study led by Mehra, in which Patel and Desai of Surgisphere were involved in, has been retracted by the New England Journal of Medicine (NEJM), another prestigious medical journal.

The study titled “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19”, which had claimed that underlying cardiovascular disease is associated with an increased risk of in-hospital death among Covid-19 patients, has been retracted for similar reasons.  

“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’,” the retraction note read. “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.”