Ivan Orsansky of Stat reported on Brown University’s Dr. David Egilman and colleagues on how they published a scholarly paper identifying serious flaws of a J&J subsidiary DePuy’s hip prothesis study. The authors called out that DePuy’s study “had serious flows” and alleged “grave fraudulence”—serious allegations. Dr. Egilman and colleagues article link here. They noted “J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of standards of protecting human subjects; and did not secure Institutional Review Board approval for all study sties” they noted. The critique focused on the “Pinnacle metal-on-metal hip replacement system” pulled from commerce in 2013 “after many patients had to have artificial hips removed.” The study was nothing more than a “seeding study” they argued, designed to market the device to doctors rather than present a test of its safety or efficacy.
J&J now demands that a retraction. See letter sent to publisher Taylor & Francis
J&J biostatistician Jim Lesko noted the Egilman letter “contains numerous factual errors that undermine its conclusions. Moreover, the authors have omitted and failed to disclose substantial conflicts of interest.”
According to the Stat article “some 10,000 recipients of the Pinnacle hip have sued J&J, which in turn has been ordered to pay hundreds of millions to plaintiffs who claimed the device caused metal poisoning or tissue damage.” J&J has appealed the judgements. Stat notes that Egilman has “served as expert witness for some of those plaintiffs.” Stat also notes that Egilman has battled pharma before on a few occasions mentioned in the article.