(UPDATE: LANCET RETRACTS STUDY) … Journals Publish Expressions of Concern Regarding Hydroxychloroquine and ACE Inhibitor Studies in COVID-19 Patients

UPDATE 6-5-20

The Lancet has published an official retraction of the Mehra et al paper. The authors’ independent review of the Surgisphere data for the study in question could not be completed due to blocking by the company.

“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,” the editors 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.”

Dr. Mandeep Mehra, lead author of the study, and colleagues also wrote in the retraction:

“We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic,” the wrote. “We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”

Both the New England Journal of Medicine and The Lancet have published Expressions of Concern over data quality in two recently published studies of drugs used to treat COVID-19.

Concerns have been raised about one particular source of data used in the two studies. Surgisphere, a group consolidates medical records from around the world, has recently been questioned by more than 200 scientists looking to get the group to provide more transparency about its data collection.

The NEJM correspondence took aim at a May 1 study in the NEJM by Mandeep Mehra, et al, entitled “Cardiovascular Disease, Drug Therapy, and Mortality in COVID-19.” According to the statement, the Mehra paper “used data drawn from an international database that included electronic health records from 169 hospitals on three continents,” they wrote.

It continued: “Recently, substantive concerns have been raised about the quality of the information in that database. We have asked the authors to provide evidence that the data are reliable. In the interim and for the benefit of our readers, we are publishing this Expression of Concern about the reliability of their conclusions.”

The author, Eric J. Rubin, MD, PhD, directed readers to two other May 1 studies that used independent data.

Study on Hydroxychloroquine

The Lancet editors published a statement online on June 2 about another high-profile study published in its journal by the same author, entitled “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.”

The statement read in part: “Important scientific questions have been raised about data reported in the paper by Mandeep Mehra, et al […]. Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with the Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information.”

Previous DocWire News coverage of this Lancet study can be found here. An update will be published with any retraction or other updates.