Dodgy Infuse Bone Graft Study Catches Grassley's AttentionMay 19, 2009 | Parker Waichman LLP
A scandal involving a falsified Infuse Bone Graft study conducted at Walter Reed Army Hospital has caught the attention of medical industry watchdog, Sen. Charles Grassley (R-Iowa). According to The Wall Street Journal, Grassley has sent letters about the study to Walter Reed, Medtronic, Inc., the Journal of Bone & Joint Surgery, and the Washington University School of Medicine in St. Louis. Dr. Timothy Kuklo, the former Walter Reed surgeon who conducted the study on Medtronic's Infuse product, is now on staff at Washington University.
As we reported last week, Kuklo's Infuse Bone Graft study, which claimed to show that wounded soldiers’ leg injuries healed better when the product was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.
According to The New York Times, which originally broke the Kuklo story, Grassley has been investigating Infuse for some time over claims that Medtronic illegally promoted its off-label use. Some have charged that the company paid doctor consultants to hype such uses. Kuklo, who was at Walter Reed between 2003 and 2007, is a paid consultant for Medtronic, but the company maintains he wasn't affiliated with it when he worked on the Walter Reed study, The Wall Street Journal said. However, the Times has reported that during that time, he was paid travel expenses by Medtronic for attending medical conferences and other events.
The Times is also reporting that Medtronic did not include Kuklo on its list of paid consultants when Grassley requested that information in September, despite the fact that he often gave talks on Infuse.
According to The New York Times, Grassley's letter to Walter Reed requested information about any payments Kuklo may have received from Medtronic during his tenure there. He also wants information on the Army's investigation as well as relevant conflict-of-interest policies.
According to The Wall Street Journal, Grassley has also asked the Journal of Bone & Joint Surgery why it published Kuklo's study after it had been rejected by another journal. He also wants to know if the publication had been told that Kuklo had a financial relationship with Medtronic.
Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.
Last July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.