UW School of Medicine and Public Health Department of Orthopedics & Rehabilitation


November 5, 2012

To all of my Colleagues, Patients and Friends:

I am writing to answer with finality any questions regarding my role in published research concerning a bone product called Infuse. Regrettably, the impression has been given to the public by a few sloppy reporters that I am somehow guilty of "hiding" research findings on complications resulting from the use of Infuse. Nothing could be further from the truth, and I hope to set the record straight once and for all.

To the best of my knowledge, complication rates associated with Infuse were never hidden by anyone involved in the research or development of Infuse. The complication in question, retrograde ejaculation (RE), is a known complication of anterior (from the front) lumbar spinal surgery. This complication has been previously reported in the medical literature to occur in up to 25% of cases. Numerous reports on this risk and its relationship to the surgical technique were written before Infuse was available. The initial data from the FDA trial that lead to Infuse’s approval appeared to show a higher rate of RE when Infuse was used. However, when further statistical review was erformed by Medtronic’s statisticians, isolating all of the surgical variables, it was found that the type of surgical approach performed was the culprit, and that the use of Infuse did not significantly alter the complication rate. A correction was made and all statistically significant findings were reported.

I know nothing of any "ghost-writing" or conspiracy to promote the product in question — and I have absolutely no financial interest in Infuse, so would hardly have motive to ruin my professional reputation by falsely promoting its effectiveness. Laparoscopic or trans-peritoneal approach to the lumbar spine results in a higher rate of RE than retroperitoneal approach. Based on that finding, I stopped performing laparoscopic approach. Over the next decade, I have performed more than 100 cases with both retroperitoneal approach and Infuse, without any higher risk of complication.

The relationship of the RE complication to the surgical approach has been published, but was never mentioned in any media reports. Rather, it seems some media outlets prefer to focus on the amount of royalties and consulting fees I received from Medtronic over several years, a figure I have never attempted to hide.

My royalty-based association with Medtronic is a matter of public record because of multiple university and physician-group reporting requirements which I honor. I have done my best to be honest and forthright about any and all conflicts of interest between my roles as researcher, inventor, spine surgeon and educator. It is my utmost priority, and has been throughout my years in medicine, to ensure that patient care decisions are never compromised. I am and always have been committed to use scientific analysis for the good of my patients. Let me finally assure you, my patients and colleagues, that I hold patient improvement and safety as the "true north" of my practice.

Sincerely,

UW School of Medicine and Public Health

Thomas A. Zdeblick, MD

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