Bogus Infuse Study Doctor Could Face Army Court-Martial

The former army surgeon accused of falsifying data in a study on <"">Medtronic Inc.’s Infuse Bone Graft product could face a court-martial. According to The New York Times, Dr. Timothy R. Kuklo could be called back to active duty if an investigation now underway at Walter Reed Army Hospital finds that there is sufficient evidence for court-martial charges.

Kuklo retired from the Arm in 2006. As we’ve reported previously, his disputed study claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used. But 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’s study was published in the Journal of Bone & Joint Surgery in August 2008, but retracted last March.

In June, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly $850,000 in direct and direct payments. Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products. In 2006, he signed on as a consultant for the company. After the accusations against Kuklo were made public, Medtronic suspended and then ended its consulting contract with him. Medtronic has maintained that it had nothing to do with Kuklo’s Infuse study.

The scandal over Kuklo’s study has prompted several investigations, including one that is still being conducted by Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee. The New York Time learned of the court-martial investigation in an email from the chief legal adviser to the commander of the Walter Reed Health Care System, who was responding to a Freedom of Information Act request. According to the Times, the investigation has also been confirmed by Col. Norvell V. Coots, commander of the medical center.

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. In July 2008, 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.

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