In the first big research scandal of the Covid-19 era, The Lancet and The New England Journal of Medicine (NEJM) today retracted two high-profile papers after a company declined to make the underlying data for both available for an independent audit, following questions being raised about the research. The Lancet paper, which claimed an antimalarial drug touted by President Donald Trump for treatment of COVID-19 could cause serious harm without helping patients, had had a global impact, halting trials of one of the drugs by the World Health Organization (WHO) and others.
Three authors on the Lancet paper requested the retraction, after initiating an independent review of the raw hospital patient data summarized and provided by Surgisphere, a small Chicago-based company operated by Sapan Desai, the fourth author of the study. Desai had previously said he and his co-authors—cardiac surgeon Mandeep Mehra of Harvard University and Brigham and Women’s Hospital, Frank Ruschitzka of University Hospital Zürich, and Amit Patel, an adjunct faculty member at the University of Utah—were getting such an audit of the data, but the agreement apparently fell apart.
“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,” making the outside audit of the data impossible, the three co-authors wrote in the retraction statement. “Based on this development, we can no longer vouch for the veracity of the primary data sources.”
The NEJM study that was retracted had concluded, based on Surgisphere-provided data from hospitals around the world, that taking certain blood pressure drugs, including angiotensin-converting enzyme (ACE) inhibitors, didn’t appear to increase the risk of death among COVID-19 patients, as some researchers had suggested.
NEJM published only a short statement from the paper’s authors, which included Mehra, Patel, and Desai, as well as SreyRam Kuy of Baylor College of Medicine and Timothy Henry of Christ Hospital in Cincinnati. “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,” they wrote, with apology. By including Desai, the note perplexingly suggests he has no access to the raw data generated by his own company.
A third study using Surgispgere data and co-authored by Mehra, Patel, and Desai, among others, was only posted online as a preprint. (It is no longer available.) It reported ivermectin, an antiparasitic drug, dramatically reduced mortality in COVID-19 patients, prompting increased use and government authorization of the drug in several Latin American countries.
The Lancet paper was what brought Surgisphere under scrutiny as it focused on the safety and effectiveness of the malaria drug hydroxychloroquine for COVID-19, which had already become a political and scientific controversy, in large part because of Trump’s embrace of the drug. As soon as the study was published, it came under attack by clinicians, as well as experts in biostatistics and medical ethics who questioned how Surgisphere, a tiny company without much publishing experience in big data analysis, could have collected and analyzed tens of thousands of patient records from hundreds of hospitals—particularly given the complexities of navigating patient confidentiality agreements.