Infuse Bone Graft Study Doc Didn't Tell School He Was Paid by MedtronicJul 15, 2009 | Parker Waichman LLP
The former Army surgeon at the center of a scandal involving falsified data in an Infuse Bone Graft study apparently did not tell his current employer that he had been a paid consultant to Medtonic Inc., The Wall Street Journal is reporting.
Infuse Bone Graft, which is manufactured by Medtronic., 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.
As we’ve reported previously, a study conducted by Dr. Timothy Kuklo during his tenure at Walter Reed Army Hospital claimed to show that wounded soldiers’ leg injuries healed better when Infuse 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.
Kuklo is now retired from the Army. According to The Wall Street Journal, he joined the faculty of Washington University medical school in St. Louis in 2006. In a letter to Sen. Charles Grassley (R-Iowa) dated June 23, Washington University's medical-school Dean Larry J. Shapiro said Kuklo failed to properly disclose his financial relationship with Medtronic.
When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo's Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007.
The letter also said that the university discovered "extensive personal health information" for soldiers treated at the Walter Reed Army Medical Center from 2006 and before on computers used by Kuklo. According to the Journal, the privacy of medical records is strictly regulated by the Health Insurance Portability and Accountability Act (HIPAA).
According to The Wall Street Journal, Kuklo is on a paid personal leave at the request of the university.