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Infuse Bone Graft Study Info Sought by Senate Armed Services Committee

Jul 9, 2009 | Parker Waichman Alonso LLP

A Senate investigation into a bogus Infuse Bone Graft study is heating up.   According to The Wall Street Journal, the Senate Committee on Armed Services has asked the U.S. Army to provide it with the results of an investigation into the Infuse Bone Graft study, which was conducted at Walter Reed Army Hospital by former Army surgeon Timothy Kuklo.

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.

As we’ve reported previously, Kuklo's 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.

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.

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.  The Senators are just the latest to express an interest in the Kuklo debacle.

Late last Month,  Medtronic revealed that it had received a subpoena from the U.S. Attorney’s office in Boston, MA. In addition to information on Kuklo’s Infuse study,  the subpoena also sought  information about “contracts, research grants, speaking and education programs, and payments for certain named physicians.”

Sen. Charles Grassley (R.- Iowa) has also been investigating the Kuklo Infuse study as part of his investigation into the financial relationships between medical firms and doctors and researchers.