Last August, when a British medical journal published a study by five current and former U.S. Army surgeons, the results seemed enormously promising for soldiers who had been maimed in Iraq and for Medtronic Inc.
Probing cases from Walter Reed Army Medical Center, one of the nation's top military hospitals, the article indicated that a Medtronic product that grows and repairs bone could offer a better chance of recovery for soldiers whose legs had been shattered in combat.
Since then, however, an Army investigation has found reason to think that the study overstated the effectiveness of the Medtronic product, inflated the number of patients who were treated and was published without the knowledge of four "co-authors,'' whose signatures were forged.
The case has turned into an embarrassment for Medtronic, which had paid more than $850,000 in fees and expenses to the lead author, Dr. Timothy Kuklo, between 2001 and 2009.
Medtronic says it had no role in the study or knowledge of its publication. But the case has prompted an inquiry by the U.S. Justice Department and Congress, intensifying the scrutiny that has come to bear in the last few years on medical device companies and their financial relationships with doctors.
The Army's wide-ranging investigation provides a rare window into a purported case of medical research fraud.
The article was published in The Journal of Bone and Joint Surgery and written by Kuklo, a highly regarded West Point graduate who retired from the Army in 2006 and is now on the medical faculty at Washington University in St. Louis.
Problems cropped up almost immediately, when a neighbor and fellow physician congratulated Dr. Romney Andersen, an orthopedic surgeon at Walter Reed who was listed as one of four co-authors. Andersen apparently was unaware of the article until that moment.
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