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Doctor Falsified Infuse Study, Army Says

Posted by Chrissie Cole
Thursday, May 14, 2009 10:09 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Medical Devices, Off-Label Use, Medtronic Inc., Infuse, Spinal Surgeries


IMAGE SOURCE: Medtronic Web site on Infuse Bone Graft

A former surgeon at Walter Reed Army Medical Center made false claims about a bone-growth product sold by Medtronic Inc., a U.S. medical device maker.

An investigation by the hospital found that former Army surgeon Timothy Kuklo misreported the benefits of the Infuse bone-growth product allegedly falsifying the number of patients and injuries studied, reports the New York Times.

He reported the device had a much higher success rate in healing shattered legs of wounded soldiers at Walter Reed, said Col. Norvell Coots, Medical Center Commander.

According to Coots, Kuklo forged signatures of four Walter Reed doctors on a research article submitted to a British medical journal, falsely asserting they had helped write it. Kuklo is also accused of not obtaining the Army’s required permission to conduct the study.

“Medtronic did not finance or review Kuklo’s study of its Infuse product, but reportedly declined to say when it hired him or how much he has been paid over the years,” said a Medtronic spokeswoman.

Several calls and e-mails to Dr. Kuklo by the Times’ for comment were not answered.

The results Dr. Kuklo reported in his Infuse study “suggested a much higher efficacy of the product being researched in the article than is supported by the experience of the purported co-authors,” according to the Army’s investigation.

Colonel Coots said the total number of patients Dr. Kuklo reported as having been treated at Walter Reed during the study period – 138 soldiers – was greater than the number for which the hospital could find records.

“It is a significant breach of academic protocol,” Colonel Coots said. “It’s a breach of trust.”

Colonel Coots handled the matter by notifying the journal and having the article retracted and by notifying the university and Medtronic as well as several orthopedics professional groups, rather than calling Dr. Kuklo from retirement to face possible Army discipline.

Infuse Off-Label Use

Medtronic has also been accused of improperly promoting its Infuse device for off-label use – allegations the company denies.

The Infuse device was approved by the FDA in 2002 for a small section of the spine in the lower, lumbar region. Approximately three-quarters of the reports on Infuse side effects have involved off-label use.

But because doctors are free to use any FDA approved product for whatever purposes they see fit, surgeons at Walter Reed used the product to see if it could help soldiers with far more severe, combat-related injuries.

The Infuse device is meant to help bone growth. The implant includes biologically engineered protein to coax bone growth. The device is widely used in surgeries to fuse or join two vertebrae together to stabilize the spine. #

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