Artificial hip maker demands retraction of a paper calling its research ‘grave fraudulence’

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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About Peter Coffaro 462 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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