Department of Justice Investigates Fraudulent Medtronic Infuse Study
The New York Times reported that the U.S. Department of Justice has begun an investigation into possible medical research fraud by a former surgeon at Walter Reed Army Medical Center, Dr. Timothy Kuklo, following an Army investigation into the matter. Kuklo is accused of fabricating the results of a study comparing bone grafts to Medtronic Infuse, a bone-growth product, and forging the signatures of other Army doctors on the study. Senator Charles E. Grassley of Iowa has also been looking into the issue.
According to the Army’s investigation, Kuklo’s study, published in The Journal of Bone and Joint Surgery in August 2008 and based largely on soldiers treated at Walter Reed, found that Infuse was far more effective than traditional bone grafts for the treatment of fractured shins. However, some of Kuklo’s colleagues believe that the results were inaccurate because many of the soldiers included in the study had received both bone grafts and Infuse, rather than one or the other. The investigation also found that Kuklo had forged the signatures of several other Army doctors at Walter Reed. While it is not uncommon in the military for one officer to sign for another when it is expedient, Kuklo did not indicate that he was signing for his co-authors when he submitted the study, nor did he inform the other doctors that he was listing them as co-authors. The Journal of Bone and Joint Surgery, a British medical journal, retracted the study in March 2009 and has banned Kuklo from publishing again in the journal. The study had previously been rejected by The New England Journal of Medicine and another American medical publication.
Kuklo’s Relationship With Medtronic
Investigators have also questioned Kuklo’s relationship with Medtronic. The company financed some of the doctor’s research and travel while he worked at Walter Reed, and when he left the hospital in August 2006, they hired him as a consultant. Kuklo did not disclose his relationship with Medtronic when he submitted his study for publication. Since he left Walter Reed he has been employed as a medical professor at Washington University in St. Louis. Dr. Kuklo is on leave while the school conducts its own inquiry into the matter.
Medtronic has previously been investigated by the Department of Justice for off-label marketing of Infuse Bone Graft. Infuse was being marketed for use in cervical spine (neck) surgeries, for which it had not been approved by the Food and Drug Administration. In July 2008, the FDA issued a warning about off-label use of Infuse, stating that it could result in dangerous or even deadly complications. Such side effects have been the subject of Medtronic Infuse lawsuits.