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Two retractions, one database – a medical scandal in COVID19 season

Two studies based on data from the same database have been retracted leaving The Lancet and the New England Journal of Medicine red-faced

 

In a bit of a scandal, two prominent medical journals have retracted two studies that drew from the database of a Chicago-based company, citing problems with data quality.

The Lancet wrote: “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. They 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.” The Lancet takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were 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.” 

At the Centre of ask this is Surgisphere, whose registry “an aggregation of the deidentified electronic health records of customers of QuartzClinical…”

The World Health Organisation has already revised its decision on HCQ and reinstated it as one of the arms of the multi country SOLIDARITY trial. The decision to suspend that arm was taken after the study in question.

In another development the New England Journal of Medicine too has printed a retraction note for a study it printed last month. The note reads: “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. 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.” The two studies have three authors in common.

At the Centre of ask this is Surgisphere, whose registry “an aggregation of the deidentified electronic health records of customers of QuartzClinical, Surgisphere’s machine learning program and data analytics platform”. The company has vouched for the integrity of its own data even though it has cited client confidentiality agreements to not give access to it.

“One of the core principals at Surgisphere is based around data integrity. Another is centered on data security. Our entire ISO 9001:2015 and ISO 27001:2013 certificate and various audits that we have completed all focus on these two foundations of the company, and the data acquisition, warehousing, analytics, and reporting processes that relate to them. It is vitally important that our colleagues around the world understand the validity of our database as it relates to those functions, especially where the data comes from, the database, and the statistical analysis,” the company said in a statement following an earlier expression of concern by The Lancet on the HCQ study.

Dr O P Choudhury
Dr O P Choudhury
Dr O P Choudhury is a founding member and the editor of MediBulletin.com. A practising doctor for the last 22 years, he has been working in the neurology department of Indraprastha Apollo Hospitals for more than ten years. You can contact him at: dr.opchoudhury@medibulletin.com
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