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Medtronic Didn’t Tell Grassley It Was Paying Walter Reed Surgeon

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Medtronic Inc. did not disclose that Dr. Timothy Kuklo, a former Walter Reed surgeon who conducted a study on the company’s Infuse Bone Graft product, was a paid consultant when asked for  a list of such physicians last fall by Sen. Charles Grassley.  Now, according to a report in the Associated Press, the Iowa Republican wants to know why.

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.  According to The Wall Street Journal, Medtronic had submitted a list of  22 consultants to the Senator in October, but Kuklo’s name wasn’t on that list.   Grassley has now written a letter to Medtronic asking why.

A Medtronic spokesperson told The Wall Street Journal that Kuklo was a consultant for the company starting in 2006. The spokesperson also said that Kuklo was a consultant until earlier this month, but  is “no longer active as a consultant.”

According to the Associated Press, Medtronic maintains that Kuklo’s name was omitted because Grassley only asked for names of doctors who had consulting contracts for Infuse, and Kuklo was a “general consultant.”  The company said it is cooperating with Grassley’s investigation.

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.

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.

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