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Military Physician Accused of Fabricating Study Regarding Medtronic’s Infuse

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Medtronic, a medical device manufacturer, has suspended its consulting agreement with Dr. Timothy Kuklo, a former military physician at Walter Reed Army Medical Center who was accused by the Army of falsifying research involving the use of one of the company’s products, a bone-growth treatment called “Infuse”, which is used on injured soldiers; Kuklo was hired by Medtronic in August of 2006 as a consultant and also has a product development and royalty agreement with the company involving spinal devices unrelated to Infuse. The status of this other agreement is unknown.

The controversy erupted when a top Senate Republican, Charles Grassley, reprimanded Medtronic for allegedly illegally promoting unapproved uses for Infuse. Medtronic denied the allegations and provided him a list of doctors who consult for the company on the product. After Kuklo’s name came to light in a New York Times Article, Senator Grassley’s staff checked the consultant list and Kuklo’s name did not appear. This promped the Senator to write a letter to Medtronic’s president requiring answers for the omission. Medtronic claims the reason the name was absent was because Kuklo had a general consulting contract with Medtronic, not one specific to Infuse. The company further agreed to provide Senator Grassley with information on Kuklo.

This year a British medical journal retracted an article published by Kuklo in which he reported Infuse worked better than any other product in healing the shattered legs of injured American soldiers in Iraq. In an inquiry by the Army, officials found Kuklo had forged the names of four colleagues he claimed were the co-authors of his study and presented fabricated data that did not match Walter Reed patient records. A spokeswoman for Medtronic acknowledges Kuklo was a paid consultant, however, she claims her company had not underwritten the challenged story.

Military physicians are allowed to accept money to consult for medical product companies if they are given permission. No records of consent, however, have yet to be found though officials are still searching. Medtronic has suspended its consulting relationship with Kuklo until the controversy is resolved.