On August 28th, John Fauber of the Journal Sentinel, a Milwaukee, Wisconsin based on line publication, penned an article entitled; "Bone Fusion Protein Raises Questions About Doctors Financial Stakes." For whatever reason, there seems to be no love lost between Mr. Fauber and Tom Zdeblick, M.D. of Medtronic Fame.
In retrospect, this article sheds some light on the FDA process, Dr. Zdeblick, Medtronic and Infuse. In 2002, the FDA advisory panel had raised some concerns about nine of the doctors that had lobbied their research on the efficacy of BMP-2 in spinal fusions. Ironically, not only did each physician have a vested interest in the success of the product, their clinical outcomes were twice as good as doctors that did not have financial ties to its success.
Over the last few years concerns have been raised regarding the off-label use of Infuse, and the potential adverse reactions in patients. Yet, TSB believes that this is clearly a separate issue from how Dr. Zdeblick was compensated, mainly for his IP and expertise as a spine surgeon. Industry insiders are well aware of the recent stir about off-label use of Infuse in Anterior Cervical Discectomies, whereas in 2008, Medtronic was sued by the family of a California woman claiming the company had urged off-label use of its device after the FDA had warned doctors not to do so.
The story of BMP-2 continues to raise questions about whether doctors should be allowed to do clinical trial research involving products that might enrich them, or the companies that they work for. Dr. Richard Deyo finds it alarming that so many prominent surgeons have cozy relationships with companies. For the obvious reasons, Dr. Zdeblick is the primary target of this article, having received roughly $22 million dollars in royalties and payments from Medtronic since 2002. This may surprise some of our readers, but TSB has no problem with Dr. Z being compensated for his IP, time, and expertise. Whom else is the FDA going to listen to? Historically companies have used surgeons to line their pockets. Rogazinski, Charnley, Russell-Taylor etc.... are a few surgeons that contributed to the betterment of mankind and also to the revenue and profitability of the companies that they worked with. What concerns TSB is not the compensation, but the lack of oversight by an FDA panel as to the potential side effects of this pharmaceutical.. Yes, fellow readers, regardless that this product was approved as a device, it is still a pharmaceutical. Since carpentry plays a prominent role in preparing the disc space, could it be that teaching surgeons how not to use Infuse was Medtronic's faux pas from the start. Each of you know the industry adage, give a doctor a hammer and everything becomes a nail. Well if 2cc's worked well the first time, why not administer 6cc's and see what happens? Hopefully, surgeons have learned something over the years, that its not the Infuse that makes the procedure successful. If the FDA was that concerned with off-label use, they should have addressed it at the time of the application while scrutinizing this panacea. For Medtronic to claim that it did not advocate off-label use is debatable. But, how does one legally prove a "he said, she said scenario?"
What concerns the industry and probably hurts many of the surgeons affiliated with Medtronic, is that after years of defending its reputation in various whistleblower lawsuits, Medtronic now behaves as though it has become the moral and ethical compass for the industry. As it crusades for more oversight, it continues to obfuscates its behavior and hides behind the skirt of AdvaMed. So as Amplify begins its final journey for approval, many questions are being raised by Mr. Fauber as to whether the FDA is complicit in covering up the physicians whom consulted by redacting sections of its 2001 files that listed the financial disclosure of the Infuse investigators, claiming at first that this information was no longer available, then claiming that they erred and the information is available, but, that the information would be hard to find. Old news is old news, unless we learn something from past experiences.
The North American Spine Society is just as complicit it their inability to properly police its members from becoming a commercial advocate for specific companies or products. But TSB wouldn't expect otherwise. As a minority of surgeons spend too much time worrying about how much sales reps make, rather than can they prep the disc space properly. Maybe some due diligence on their own behavior would make them ask the question, "look at whom is calling the kettle black?" Like Dr. Zdeblick, TSB would have a clear conscience being paid $22 million dollars for my expertise or intellectual property. But this raises an even greater concern, whom do you think pays for these royalties? Doctors love to cry about how they are always getting screwed, unfortunately, its difficult to side with them when you read stories like the one about Dr. Zdeblick regardless whether you believe in free-markets or not. TSB wants to know what our readers think. Is this a fair attack on Dr. Zdeblick, or, do you believe in free and unfettered markets? In closing, its there a better way to manage these scenarios, or, is the problem that this industry just can't find a better sandbox to climb into?