The Lancet and NEJM recently retracted 2 studies after questions arose regarding the validity of the data used as the basis of the studies.
The Lancet was the first to retract an influential study that found the investigational malaria drugs were associated with an increased risk of death. The retractions came at the request of the authors of the studies, who were not directly involved in data collection and sources.
“After publication of our Lancet Article, 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,” said Mandeep R. Mehra, MD, from Brigham and Women’s Hospital Heart and Vascular Center, Frank Ruschitzka, MD, of University Hospital Zurich, and Amit Patel of University of Utah, in a statement. “We can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.”
About an hour later, the NEJM retracted a separate study that examined blood pressure medications among COVID-19 patients.
Both studies used data that was provided by Chicago-based data collection company Surgisphere, that says it gathers and stores de-identified electronic health record data from 1200 healthcare organizations in 45 countries. Surgisphere founder Sapan Desai, MD, PhD, is listed as a co-author in both studies.
The study published in the Lancet particularly gained attention because it went further than other observational studies that found chloroquine and hydroxychloroquine were not linked with improved patient outcomes. In fact, the study reported that hydroxychloroquine was associated with a nearly 50% increase in risk of in-hospital mortality.
The results even prompted the World Health Organization (WHO) to suspend clinical trials of the drugs.
“The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board,” said Tedros Adhanom Ghebreyesus, PhD, director general, WHO, Geneva, Switzerland, in an online press conference on May 25, 2020. “I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria.”
Scrutiny increased after questions were raised regarding inconstancies in the data, which ultimately led study authors not affiliated with Surgisphere to ask the company to explain how it sourced its data.
That request, however, fell flat. In the NEJM retraction statement, the study authors wrote, “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.”
It is important to note that chloroquine and hydroxychloroquine are safe for the treatment of malaria, rheumatoid arthritis, and lupus, and for whom they are shown to have benefits.