A former doctor at Walter Reed Army Medical Center has been accused a falsifying a study which extols the virtues of Infuse, a bone graph product manufactured by Medtronic. At the time the study was published, Dr. Timothy R. Kuklo was a paid consultant for Medtronic.
After conducting an investigation, the Army claims that Dr. Kuklo's study makes false claims and overstates the benefits of Infuse that was used to treat soldiers severely injured in Iraq. Specifically, the Army claims to have no record of a large number patients reported to be part of the census used to support the study findings. The Army also alleges that the success rate for bone healing reported by Dr. Kuklo was inconsistent with that reported by other Army doctors using Infuse under the same or similar circumstances. Finally, the Army claims that Dr. Kuklo forged the signatures of four doctors falsely indicating they are co-authors of the study and that Dr. Kuklo published the study without its permission.
One of the four supposed co-authors, Lt. Col. Romney C. Andersen, brought the bogus study to the attention of the Army. The British medical journal that published the study retracted it this March at the Army's request. The Army has provided the results of its investigation to Medtronics chief executive and to Dr. Kuklo's current employer, Washington University School of Medicine in St. Louis.
Not surprisingly, Medtronics denies any wrongdoing and the university will not confirm that it is investigating Dr. Kuklo. But Dr. Kuklo is still on the faculty and he is keeping a low profile by refusing to participate in the Army's investigation or to respond to any inquiries concerning the study. This is one more example of big business and big medicine blurring the lines between maximizing profits and independent research. Where does it end and who is watching out for the patient?
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Let's get the facts straight. Innovation in medical devices is commonly the result of industry and physicians working together. Medtronic did not participate in the collection or analysis of the data, the preparation of the manuscript for the journal article, or the submission of the journal article for publication. Additionally, the study was not funded by Medtronic, either directly or indirectly. Neither the JBJS article, nor the data presented in that article, was used by Medtronic to secure any current indication for any product, including INFUSE Bone Graft. And since the article was called into question, we are not using it or the data to seek regulatory approval for any product.Dr. Kuklo has been involved in a large number of research projects in his own right and he is also an author of numerous scientific papers and published journal articles. Neither the retrospective study conducted between 2003 and 2005 that formed the basis for the JBJS article, nor the submission and publication of this particular journal article was related to Dr. Kuklo's role as a consultant to Medtronic.
I have written on this extensively and the post by David, an obvious employee of Medtronic is risible. Dr Kuklo was a consultant and frequent flyer on Medtronic's expense and an outspoken advocate of infuse. He had a conflict of interest due to his financial emuneration and peddling bone-growth protein of LIMITED efficacy. He faked data; he invented patients that did not exist; he faked four signatures on the article of co-authors in a shameless manner; he did not adhere to army regulations on publications and has endangered the public and particularly patients whose physicians may have used a product of minimal effectiveness. To think a West Point graduate would treat injured soldiers in the Iraq war and lie and falsify data about them which could harm future soldiers merits revocation of his MD degree from U Conn and his expulsion from the medical profession. His article is already removed from the Journal of Bone and Spine and he is banned from ever publishing again there. Dr Kuklo is a disgrace to the medical profession and should be fired from Washington University in St Louis School of Medicine and possibly indicted for criminal conduct in presenting false medical research that could harm patients.
I meant remuneration and Journal of Bone and Joint Surgery. I regret the errors written in haste.
Do these allegations place every study Dr Kuklo has authored under suspicion? And how can an Army officer moonlight as a consultant to a medical device manufacturer?
While Advid and Dr. Kirstein represent the most extreme views on this subject. Remuneration has not been proven, nor has hold harmeless by medtronic been established. All at this point is speculation by the commentators. But having worked in the medical device field for sometime. I know that when I see an MD with a JD, I have to wonder about career motivations. I think this individual would have used any product establishment as a vehicle to his own end, no matter the consequences. Many Doctors suffer from these same complexes of grandeur and self design. In the end he has probably hurt a worthy study and hurt the ability to try and bring good products to the market to alleviate patient suffering. The law, probably adjucated, will deal with these individuals in the end. Opinions are only important in relevant Court cases.....
To 'Dr.' Peter N Kirstein, It seems that you have arrived at a diagnosis without an examination! You 'doctor', in arriving at your determination, are a disgrace not only to your profession, but to all that is just. I sincerely hope that your patients always ask for a second opinion. It also seems odd to me that a 'doctor' can't seem to post a comment without later correcting his original comment. Really now, are you really a doctor?
Dr. Peter N Kirstein, Are you the Peter N Kirstein from Saint Xavier University as mentioned in the following? More ... You sir, are a disgrace to the human race and should have no right to comment on anyones credibility.
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