Category: Expert Opinion on Drug Safety

Exclusive: Journal bans drug safety database papers as they flood the literature

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Starting around 2023, a curious trend took hold in papers on drug safety monitoring. The number of articles published on an individual drug and its link to specific adverse events went from a steady increase to a huge spike. 

The data source in most of those articles was largely the same: The FDA Adverse Events Reporting System, or FAERS. In 2021, around 100 studies mining FAERS for drug safety signals were published. In 2024, that number was 600, with more than that already published this year. 

Two journals in particular published the bulk of these papers, Frontiers in Pharmacology and Expert Opinion on Drug Safety. In response to the flood, Frontiers started to require independent validation of studies drawing on public datasets. And Expert Opinion on Drug Safety decided in late July to stop accepting submissions altogether that use the FAERS database for this particular type of study. 

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Authors defend publishing clinical trial six times, even as they earn two more retractions

Screen Shot 2015-09-30 at 12.14.06 PMIn August, we reported on a clinical trial on hundreds of hypertensive patients that was published six times. Now, copies published in Expert Opinion on Drug Safety and Journal of the American Society of Hypertension (JASH) have been retracted, making for a total of three retractions for the group of papers.

The authors have defended the papers as being decidedly “different,” but one of the latest retraction notes points to an earlier retraction by some of the same authors (including first author Giuseppe Derosa, at the University of Pavia in Italy) for publishing two papers that “contain considerable text that is duplicative.”

Inflammation editor in chief Bruce Cronstein, who retracted one of the six duplicated papers from the clinical trial, told us in August that he and the editors of the other journals were all contacted “en masse” by an author doing a Cochrane Review on hypertension, who noticed that all six papers were “nearly identical.”

Just recently, we received a statement from the authors — sent by corresponding author Derosa — which argued that even if six papers stem from one trial, each was decidedly “different:”

Continue reading Authors defend publishing clinical trial six times, even as they earn two more retractions