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Medtronic, Inc., implicated in doctor's fraudulent study supporting bone-growth product, Infuse.

Dr. Timothy Kuklo, a West Point graduate, attorney and surgeon specialist who recently retired from the Army, is alleged to have falsified information used in an article he wrote supporting the effectiveness of Medtronic's "Infuse" to assist bone-growth after trauma.  His article was originally published in a British medical journal, which retracted the article after one of the three physicians whom Kuklo listed as co-authors challenged his claims. 

After Dr. Romney Anderson, one of the supposed "co-authors," and currently commander of a combat hospital in Baghdad, challenged the veracity of the study, Walter Reed Army Medical Center, where it was allegedly conducted, found that it cited more patients than the hospital could account for.  The hospital commander concluded "this really was all falsified information."  Kuklo, now an associate professor at Washington University medical school in St. Louis, reportedly refused to respond to inquiries from Walter Reed or the newspaper investigation.

Army investigators reportedly concluded that Kuklo forged his companion doctors' signatures on the article and also failed to obtain the Army's required permission to conduct the study on Army veterans.  While at Walter Reed and since, Kuklo has been paid by Medtronic as a consultant and has given talks to other surgeons attesting to the efficacy of the product.  Sales of Infuse reached $419 million dollars during the six months ending October, 2008.  Walter Reed physicans report that Infuse was effective in treating some soldiers' gaping leg wounds, but not at the 92 percent level of success reported by Kukla. 

The FDA issued a safety alert in 2008, suggesting that Infuse, if used in neck surgeries, could cause breathing problems.  Kukla has published more than 100 orthopaedic articles and while at Walter Reed, he edited two books published by the company, conducted three studies approved by the Army and was "extensively involved in research and writing about various Medtronic products."  He listed Medtronic as a financial supporter in a 2005 disclosure about Infuse. 

We wonder if disabled Army vets and U.S. taxpayers shouldn't share in the bounty from Infuse and Kuklo's "breach of trust."  Why do we allow private doctors and corporations to profit from research conducted on our injured soldiers, anyway?

Thompson O’Neil, P.C.
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