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Orthopedic and Dental Industry News Complete Archive »

More Trouble for InFuse as Fraudulent Data Makes Headlines BY LAUREN UZDIENSKI, MAY 20, 2009

The New York Times reported last week that a former surgeon at Walter Reed Army Medical Center falsified data on InFuse that was published in (and later retracted by) JBJS.

The study in question evaluated the use of InFuse for the treatment of open tibial fractures of soldiers injured in Iraq. The patients who received InFuse had a bony union rate of 92%, compared to 76% for the patients who did not receive InFuse. However, according to the JBJS retraction letter, one of the study's credited co-authors contacted the journal following publication saying they had not seen the final manuscript nor had they signed the submission letter. Further, in their own investigation, Walter Reed found that the "study cited higher numbers of patients and injuries than the hospital could account for," implying that portions of the data were entirely fraudulent. In response, Sen. Charles Grassley has launched his own investigation into the study, with the Wall Street Journal reporting that he has made inquiries to Walter Reed, Washington University, Medtronic and JBJS concerning the matter.

The surgeon, who is currently on staff at the Washington University School of Medicine in St. Louis, is a consultant to Medtronic, though the company says he was not a consultant at the time the study was conducted. Still, this news follows a spate of bad press for Medtronic's InFuse, which so far has largely concerned off-label use of the product in cervical fusions. This negative attention seems to have a had a detrimental effect on sales, with Medtronic reporting a 1% decline in biologics revenue in the fourth fiscal quarter of 2009, which it announced on Tuesday.

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