Medical journal The Lancet publicly acknowledged Tuesday that a massive study on hydroxychloroquine that raised serious health concerns about the anti-malaria drug was potentially flawed.
The Lancet issued an “expression of concern” on a study it published last month of nearly 100,000 patients that tied hydroxychloroquine and chloroquine to a higher risk of death in hospitalized patients with the coronavirus.
The journal said that “serious scientific questions have been brought to our attention” about the study and that the authors have commissioned an independent review of the data.
When it was published in late May, the study of 96,000 hospitalized COVID-19 patients across six continents was touted as the largest and most definitive analysis to date on the effects of treating COVID-19 patients with hydroxychloroquine or chloroquine.
The study found that the drugs were not only largely ineffective at treating or preventing the virus but also linked to a higher risk of death.
The study relied on an analysis of a database with medical records from patients across 671 hospitals rather than a comprehensive randomized trial.
Still, the journal is highly influential, and following the study’s publication, two major clinical trials of hydroxychloroquine were paused, one from the World Health Organization and the other in the United Kingdom. France also stopped allowing the use of the drug in hospitals.
Clinical trials are still underway in the U.S.
Following the publication of the study, numerous scientists around the world raised concerns with what they said was inconsistent data in the report.
The study’s authors, led by Mandeep Mehra of Harvard Medical School, have repeatedly declined to release their underlying data, despite signing a pledge to share information on the coronavirus.
Last week, the study’s research team corrected some of its data but said its conclusions remained the same.
The company Surgisphere, which assembled the database used in the study, defended its work and said observational studies should not be substituted for randomized trials.
Controversy has swirled around hydroxychloroquine as a potential COVID-19 treatment, as President Trump has promoted it for months. He claimed he even took it himself, even though there has been no clear evidence that it’s safe or effective for preventing or treating the coronavirus. The use of the drug has turned into a partisan issue, and the update from The Lancet is likely to muddy the waters even further.