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Disclosures: Schwartz reports being an investigator on an unrelated hydroxychloroquine clinical trial.
June 04, 2020
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Lancet retracts controversial COVID-19 study on hydroxychloroquine

Disclosures: Schwartz reports being an investigator on an unrelated hydroxychloroquine clinical trial.
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Following criticism from experts regarding the validity of its data, The Lancet retracted a study that raised questions about the usefulness and safety of hydroxychloroquine for the treatment of COVID-19.

Three of the four study authors penned a retraction that was published today in The Lancet. The fourth author, Sapan S. Desai, MD, is the founder of Surgisphere Corporation in Chicago, Illinois, the company that provided data for the study.

Ilan Schwartz quote

“We always aspire to perform our research in accordance with the highest ethical and professional guidelines,” the other three authors wrote in the retraction. “We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources.”

The retraction followed a statement of concern published by The Lancet on Tuesday in which the journal said “important scientific questions have been raised” about the data reported in the study.

The authors of the retraction said a group third-party peer reviewers were unable to conduct an independent review of the data used in the study because Surgisphere Corporation “would not transfer the full dataset, client contracts, and the full ISO audit report” for analysis due to concerns that releasing the information would breech client and confidentiality requirements.

Another study that used Surgisphere data to evaluate cardiovascular disease and COVID-19 was retracted by The New England Journal of Medicine.

The situation has raised concerns among some experts regarding the speed with which research is being published during the pandemic.

“Journals like The New England Journal of Medicine and The Lancet are expediting review within 3 or 4 days, which, under normal circumstances, would be unheard of,” Ilan Schwartz, MD, PhD, a researcher and assistant professor of infectious diseases at the University of Alberta, told Healio.

“Certainly, there is a loss of thoroughness that can be expected as a consequence,” Schwartz said. “In addition, the editorial decisions may have been rushed, and general pressure to publish as rapidly as possible, and the urge for primacy — for being the first one to publish a study on a particular topic — all likely contributed to the errors and oversight that occurred.”

The authors who wrote the retraction are Mandeep R. Mehra, MD, MSc, Frank Ruschitzka, MD, and Amit N. Patel, MD.

“Hopefully, this will lead to journals taking a moment for introspection about their priorities and rush to publish, especially given the harms that we saw in this case that can be generated in terms of public trust and interfering with ongoing research,” Schwartz said.

“One general point is to be up front and transparent with the editor about your expertise and ability to review a paper,” he added. “Where somebody might be an expert on the infection or the disease, they may not have expertise on the statistical analysis or on the analysis of certain parts of observational studies. If editors are aware of possible blind spots in their review process, they could seek out individuals that can address that.”