Johnson & Johnson (NYSE:JNJ) are looking to get a scholarly paper challenging the validity an internal study of its DePuy subsidiary’s Pinnacle metal-on-metal hip systems retracted, according to a Stat News report.
The study and journal paper were published by Brown University’s Dr. David Egilman and accused the J&J study of “grave fraudulence,” according to the report.
The paper, which was based on an analysis of internal documents, claims that J&J’s trial was a “seeding study” intended to market the device and not test safety and efficacy. The paper also includes claims that J&J didn’t appropriately protect it subjects or obtain appropriate Institutional Review Board approval at all of its study sites.
Authors of the critical paper said that the initial Pinnacle study served as the basis for a number of other studies and indicated the metal-on-metal hip system experienced a low rate of serious complications and a 99.9% survivorship at five years, according to Stat. The survivorship rate was used in marketing materials for the company, despite the company’s worldwide clinical research VP claiming that the data did “not accurately reflect the data” coming from investigator sites.
Johnson & Johnson recently submitted a six-page letter to the publishers of the journal where the study critical of the Pinnacle trial was published, claiming it “contains numerous factual errors that undermine its conclusions,” and claimed conflicts of interest baed on the fact that Dr. Egilman and other authors served as expert witnesses in cases involving Pinnacle hip implants.
The request, submitted by J&J medical devices biostatistics director Jim Lesko, initially demanded either a retraction of the paper or the publication of the letter critical of Dr. Egilman’s paper, though J&J later dropped interest in publishing the letter, according to Stat.
Dr. Egilman and his colleagues responded with their own 32-page letter rebutting the rebuttal, according to the report, and said they would be fine with Lesko’s letter being published.
“Needless to say this is a baseless request and merely an effort to bully the medical and scientific community to acquiesce to corporate crime never mind irresponsible and unethical conduct,” Dr. Egilman wrote in a letter to the journal publisher, according to Stat.
Last November, a Dallas federal jury ruled that J&J and DePuy Orthopaedics must pay $247 million to six patients claiming to be injured by its Pinnacle metal-on-metal hip implants.