COVID-19 Studies with Surgisphere Data Retracted
- Authors said they can no longer vouch for the data
by Molly Walker, Associate Editor, MedPage Today June 4, 2020

RETRACTED over blurred pages of a medical journal
Two papers related to COVID-19 appearing in major journals that relied on data from Surgisphere Corp. were retracted on Thursday.

One was the large study in The Lancet published May 22 that found mortality and arrhythmia risks with hydroxychloroquine (HCQ); the other was in the New England Journal of Medicine on May 1 and purported to show that certain antihypertensive drugs did not worsen COVID-19 risk.

Authors of both papers said they could no longer vouch for the data's accuracy. Statisticians and independent researchers had questioned its veracity and both journals had recently posted "expressions of concern" in response.

The Lancet's explanation gave some details.

Lead author Mandeep Mehra, MD, of Brigham and Women's Hospital in Boston, and two colleagues said they had called for an independent, third-party review in an attempt to replicate the analyses presented in the paper, to confirm the database's completeness, and evaluate origination of the database elements. But independent peer reviewers informed the authors this was not possible.

"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," they wrote. "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."

The HCQ study, which made headlines worldwide, found hospitalized COVID-19 patients receiving the drug with or without an antibiotic had increased mortality and higher rates of cardiac arrhythmias. It purportedly analyzed data from around 96,000 patients, 15,000 of whom received HCQ or chloroquine, with or without an antibiotic. Surgisphere was said to have provided the data from 671 hospitals on six continents.

Surgisphere founder Sapan Desai, MD, PhD, was the paper's fourth author; he did not participate in the retraction request to The Lancet.

The New England Journal's retraction statement was much shorter, and did include Desai in the request.

"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," Mehra and colleagues wrote. "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."

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Edited: 06/05/2020 at 07:24 PM by Fish Killer