Rivaroxaban: Lancet is under pressure to retract “unreliable” paper as investigation drags on

Nineteen months after an investigation was promised into a trial of the anticlotting drug rivaroxaban,1 the journal and the university involved are keeping silent about progress.Rivaroxaban was examined in the Record4 study for the prevention of venous thromboembolism in patients undergoing elective total knee replacement with the phase 3 study published in the Lancet in 2009.2 However, during an inspection audit of the Record4 study in 2011, the US Food and Drug Administration (FDA) uncovered numerous and serious data integrity deficiencies at eight of the study’s 16 clinical trial sites.The trial sponsor, Janssen and Bayer (formerly Johnson and Johnson), kept the FDA’s findings quiet from the public and the trial investigators. However, after The BMJ uncovered the FDA’s findings in 2022 the Lancet published a correction,3 and Alexander Turpie, emeritus professor of medicine at McMaster University, Ontario, and lead investigator on the Record4 study, apologised for the errors.4When The BMJ…
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