The studies in question were pulled from The Lancet and the New England Journal of Medicine (NEJM) due to questionable patient health data supplied by healthcare analytics company, Surgisphere.
“Whenever you don’t know where data comes from, and precisely how it was managed, then the number of incorrect conclusions you can draw is large,” said Kenneth Mandl, director of Boston Children’s Hospital’s Computational Health Informatics Program. “The field is young enough that those best practices may not be well established across the scientific community.”
The Lancet study drew scrutiny after if it concluded that treating COVID-19 with hydroxychloroquine increased the risk of patient death. Experts who looked at the study said that the patient outcomes data from several countries did not add up.
The scrutiny led Mandeep Mehra, a Harvard Medical School professor and researcher with Brigham and Women’s Hospital, and his co-authors to retract the study, as well as a second study in NEJM. He said that he and his co-authors could not vouch for their data’s veracity and that Surgisphere would not provide its underlying data to independent auditors. Surgisphere CEO Sapan S. Desai is listed as one of the co-authors of the study.
“We can no longer vouch for the veracity of the primary data sources,” Mehra and two of his three co-authors said in a statement. Desai’s name, however, did not appear in the statement.
U.S. healthcare data has, for the most part, been concentrated in medical claims compiled by large insurers such as UnitedHealth Group Inc. and the governments. However, as hospitals have started keeping electronic health records, independent analytics firms, such as Surgispehere, have been buying hospital data sold without patient names.
In addition, the Food and Drug Administration currently allows data gathered outside of clinical trials to be considered in its reviews of new medicines. This provides yet another boost to the healthcare analytics industry.
Defenders have depicted the retractions as evidence that the peer-review system of scientific publishing works -- the papers were published, then they were subjected to painstaking scrutiny before being retracted once their shortcomings were exposed.
However, as Los Angeles Times columnist Michael Hiltzik pointed out, “the whole point of peer-review … is to catch shortcomings before publication.”
According to Ivan Oransky, vice president of editorial at Medscape and co-founder of the Retraction Watch blog, the retractions “are great examples of why science needs more of [an] ‘In God We Trust, everyone else needs to show their data’ approach.”
Retraction Watch has documented over 1,500 studies over the years for various data concerns such as falsification of data, Oransky said. In regards to COVID-19 alone, the website lists about 15 medical paper retractions.
“Yes, this is a wake-up call,” he added. “But we’ve had the wake-up call for years.”
As the global pandemic continues to spread, the retractions threaten to reduce trust in data published through scientific journals.
“Not being able to answer an important scientific question about where this data came from raises doubt amongst community members about the value of studies, or they may make up their minds based on misinformation,” said Sharon Lewin, director of the Peter Doherty Institute for Infection and Immunity in Melbourne. “If a finding is in a journal like The Lancet it can also affect clinicians and their biases. These journals change clinical practice.”
According to Peter Collington, a former advisor to the World Health Organization, the initial publication of the retracted studies would have lasting implications. He pointed out that there’s an assumption that leading journals like The Lancet and NEJM had rigorous standards.
By letting the two studies that “look suspect” and at worse, may have been “fraudulent,” go through the journals’ vetting process, Collington says that this undermines people’s trust in them.