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Senators Write Army Secretary Seeking Info on Infuse Bone Graft Study

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The Senate Armed Services Committee has launched the latest investigation into a bogus study involving Medtronic Inc.’s Infuse Bone Graft product.

The study in question was conducted by former Army surgeon Timothy Kuklo at Walter Reed Army Hospital.  His study, which  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.  According to The Wall Street Journal, in a letter to  Army Secretary Pete Geren, Sens. Lindsey Graham (R.- S.C.) and Ben Nelson (D.- Neb.) asked for the results of the Army’s investigation.

Kuklo retired from the Army in 2007. Last month, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly $850,000 in direct and direct payments to Kuklo. 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, a relationship which ended earlier this year.  However, Medtronic has maintained that it had nothing to do with Kuklo’s Infuse study.

Infuse Bone Graft, which is manufactured by Medtronic Inc., 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.

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