Last December, Brown University’s Dr. David Egilman and colleagues published a scholarly paper that identified serious flaws in a study of a hip prosthesis, and accused the medical device maker DePuy — a wholly owned subsidiary of J&J — of “grave fraudulence.”

“J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of standards protecting human subjects; and did not secure Institutional Review Board approval for all study sites,” they wrote about a clinical trial of the companies’ Pinnacle metal-on-metal hip replacement system, which was taken off the market in 2013 after many patients had to have the artificial hips removed.

The study, they argued based on an analysis of internal company documents, was nothing more than a “seeding study,” designed to market the device to doctors rather than present a test of its safety or efficacy.

The study formed the basis of several papers published starting in 2007 and seemed to show that the system worked well for five years, with a low rate of serious complications. According to Egilman and colleagues, “J&J/DePuy subsequently utilized the 99.9% survivorship at five years — which the Worldwide Vice President of Clinical Research admitted did ‘not accurately reflect the data that was at the [surgeon investigator] sites’ — in marketing materials to claim that their hip implant had a nearly perfect success rate.”

Now, J&J is demanding that the article be retracted. In a six-page letter to Taylor & Francis, which publishes the journal where the paper appeared, J&J biostatistician Jim Lesko wrote that it “contains numerous factual errors that undermine its conclusions. Moreover, the authors have omitted and failed to disclose substantial conflicts of interest.”

By Ivan Oransky & Adam Marcus | STAT

Image Credit: ADOBE



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