Since the U.S. financial market nearly crashed and burned in 2008, resulting in an economy running on quaaludes with high unemployment rates, and major bailouts for criminal banksters, with the little guy being everyone's scapegoat, we have learned that as long as we capitalize on our behavior we can rationalize success without any consequence. But can We? Yesterdays WSJ and NYT's reported that the U.S. Senate Committee on Finance reported that Medtronic edited studies by outside researchers pertaining to INFUSE (C'est Moi). This finding stems from reports alleging that physicians authors who had financial ties to Medtronic failed to report dangerous side effects associated with INFUSE. A minor omission, all for the love of the Almighty Dollar, but more on that at the end of this blog. But rather than get caught up in the Pomp and Circumstance that is always played out on Capitol Hill, let's be equitable and analyze this from a realistic perspective. There are two parties culpable in aiding and abetting these findings. Medtronic and the individual Spine Surgeons involved in the original studies. NASS your members do have a wonderful reputation. Here are the findings;
- Drafted, edited and shaped the content of the studies
- Paid $ 210 million to physicians involved in the studies
- and its employees recommended against publishing adverse effects
- prepared Hal (rust never sleeps) Matthews remarks to the FDA
- attempted to adopt weaker safety rules
As we all know INFUSE was originally approved for an ALIF surgical approach, yet the statistical analysis goes on to expose that the original issues concerning the FDA regarding INFUSE came to roost. The fact is that 85% of all lumbar surgery was off-label use in 2009, in 2008 75% of all reported adverse events were for off-label use for cervical spine, leading up to the FDA's refusal to approve Amplify in 2011. Dosing has always been an issue, as has off-label use. For the many good results that INFUSE has produced, by hiding the adverse events, and skewing the data, INFUSE'S long-term viability has been assaulted all for short-term gains. But isn't this the exact business philosophy that has driven the United States economy into a grifter society?
As a by product of this report, there are many questions that need to answered if spine is to cleanse it reputation, once and for all.
- What happens when a physician has financial ties to a company's success?
- Does this affect their ability to make legitimate rational decisions?
- How does this affect the market and "free-market" enterprise?
- What happens when employees start to collaborate with physicians on the substance and content of a clinical study?
- Does this drive up the cost of delivering healthcare?
If we believe in the "Peer Review Process," how can any company defend and accept the contributions of their employees to a clinical study? Have any of these employees contributed first-hand surgical data to these studies? If adverse events are consciously omitted, and the physician authors agreed to this tactic, what does it say about the physicians involved? TSB is not OTW, calling out the adversary for questioning the substance and content of these studies, but then TSB is not some wannabe financial advisor that kisses the ass of the industry all for the love of our own motives. Their is something fundamentally perverse when we game the system, extract hundreds of millions, if not billions of dollars from the healthcare system, and then we complain about the iron clad hand of government cracking down on healthcare delivery. As TSB's mentors use to say, "there's a right way and a wrong way of doing things." How many of you recollect the many horror stories we heard in the 2002 or 2003 from some of the surgeons involved in trialing INFUSE?
The same concerns that the FDA initially had came to fruition, off-label use. But then, the FDA should accept some blame in this game, INFUSE is a pharmaceutical and not a biologic product in the truest sense. The FDA should have held this product to a different standard. As healthcare comes under assault, the potential for profiteering has escalated whereby we no longer created new technology but new ways of gaming the system. The days of signing Dr. Famous to a consulting agreement in exchange for their business has evolved into multi-layered business models. Today, doctors don't want to be doctors, they want to be everything but being a doctor. But who's to fault for this behavior? The company's and CEO's that have built this industry? They have advocated and encouraged this aberration, we call spine. Today, the same people that poached other companies sales people or surgeon consultants cry foul when they have to compete against POD's and POC's. They orate that they have had "a sequential decline in revenue" due to market forces out of their control. Excuses, excuses, excuses. Can't handle the heat? Get out of the kitchen. Payback can be a bitch. If companies learned how to treat their employees respectfully, set realistic revenue expectations, and stopped kissing the ass of the milquetoast analysts, maybe spine would be an honorable industry. But then again, that would be wishful thinking, so party on. Another bottle of Petrus please.