Top journals Lancet, NEJM retract controversial COVID-19 studies

Boston/New Delhi, Jun 5 (PTI) Authors of two controversial studies published in The Lancet journal and the New England Journal of Medicine have retracted their research on COVID-19 as they could not vouch for the veracity of the data sourced from a private company for their analysis.

The scientists, including Mandeep Mehra from Harvard Medical School in the US, who was one of the common co-authors in the two studies, retracted the research papers stating that the members of the teams were not granted access to the underlying data for their research.

Both the studies relied on data from a private company based in Illinois, US called Surgisphere Corporation, with its CEO Sapan Desai, and Mehra being common authors in the two research papers.

The Lancet study published on May 22, claimed to have assessed data from more than 96,000 hospitalised COVID-19 patients from six continents and reported substantially increased deaths and incidences of heartbeat rhythm changes associated with the use of hydroxychloroquine (HCQ) and closely related drug chloroquine.

The one in NEJM, published on May 1, suggested that any underlying heart disease in patients hospitalised for COVID-19 treatment is associated with an increased risk of death.

Following The Lancet study, the World Health Organisation (WHO) had paused the recruitment of patients to the HCQ arm in their SOLIDARITY clinical trial.

However, in two open letters written to the editors of both the journals on May 31, more than a hundred scientists from across the world flagged major discrepancies in the quality of the data used in two studies.

The open letters noted that the HCQ research was based on a database from Surgisphere, which according the scientists, hosts COVID-19 patient data from hundreds of hospitals around the world.

It flagged several points of concern about the validity of this data, and the kind of analysis done in the study with it.

According to the open letters, case reports from governments across the world did not tally with the data used in the studies.

Citing an example, the letter written to the NEJM editor stated that it is difficult to reconcile the UK data from Surgisphere with publicly available government data.

When both the journals took notice of the raised concerns and initiated an independent peer-review on the primary source of the data, they said Mehra and his team could not furnish the original source of their information for complete analysis.

'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 authors of the study wrote in the retraction statement published in The Lancet journal.

'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,' The Lancet journal noted in a statement.

Soon, the NEJM study was also withdrawn.

'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,' the authors wrote to the NEJM editor.

They said this was because of the Surgisphere's client contracts to their servers, due to which such data transfer violated the agreements and confidentiality requirements the clients had with the company.

Some scientists part of the study, including Mehra, requested that this article be retracted along with a note of apology to the editors and readers of the journal.

Speaking about the significance of the retraction in The Lancet study, Anurag Agarwal, Director Translational Research in Lung Disease at CSIR-Institute of Genomics and Integrative Biology in New Delhi, said 'the retraction does not prove in any way that HCQ or chloroquine work, it simply proves that the concerns of very high mortality risk from the drug are unfounded.' 'We can continue with trials till we know more,' Agarwal told PTI.

'It is right that these articles were retracted. However, the failure to resolve such basic concerns about the data during the course of normal peer review raises serious questions about the standard of editing at the Lancet and NEJM -- ostensibly two of the world’s most prestigious medical journals,' Professor Chris Chambers from Cardiff University in the UK said in a statement.

'If these journals take issues of reproducibility and scientific integrity as seriously as they claim, then they should forthwith submit themselves and their internal review processes to an independent inquiry,” Chambers added.

Stephen Evans, a professor at the London School of Hygiene and Tropical Medicine in the UK said data providers should be able to confirm that they have provided data with at least the approximate numbers of patients involved.

'It is correct to retract the paper in these circumstances. Further investigations may be required,' Evans said in a statement.

Agarwal noted that in this case, the biggest fault is with the 'authors who submitted a faulty paper,' as even they had no access to the data, according to their disclosure.

'Journals and researchers must not trust the study if the co-authors do not disclose the data,' he said.

'The biggest lesson here is that if you have no idea about what the data is, don't give any analysis. This is for everybody, from authors, to journals and the WHO,' Agarwal added. PTI VIS SAR SAR