Amplify: To make larger of more powerful, to exaggerate. If only TSB was taking about the Jimmy Page, Jack White and The Edge Documentary. In Medtronic's quest to amplify rhBMP-2, on March 9th, 2011, the FDA displayed a bit of feedback by issuing a non-approval letter.
So the million dollar a day question must be asked, what was the determining factor or factors? Obviously, cooler heads prevailed. Was the panel concerned with some of the papers that have been published regarding the role of BMP's in pancreatic cancer? If there were spine surgeons on the panel, did they come to their legal and ethical senses? So what's the buzz in the sound system? TSB wonders what Marshall Urist would say if he was in the here and now? Over the years there have been many papers and reports of adverse reactions in using rhBMP-2. Let's take a look at some of these papers.
In 2008 The Department of Pharmacology and Cancer Biology, and Department of Medicine at The Duke University published a paper entitled, "BMP's Induce Pancreatic Cancer Cell Invasiveness through a small Smad1-Dependent Mechanism That Involves Matrix Metalloproteinase -2." In addition to this paper, a retrospective study reported in 2008 on 260 patients that underwent cervical spinal procedures with BMP resulting in acute airway obstruction due to extensive soft-tissue inflammatory response that was likely to occur 2-7 days post-op. Then there is the published paper in The Spine Journal in 2008 entitled. "Neurologic impairment from ectopic bone in the lumbar canal, a potential complication of off-label PLIF/TLIF use of BMP-2.
Yes fellow rockers, or may I say bloggers, contingent on whose data one wants to believe, it is estimated that 73-85% of BMP is used off label. In a September 22, 2010 report, concerns were raised that there was bone formation in unwanted places. WTF, was anyone listening to the people in the field that were being told by surgeons about their experience? It doesn't take a spine surgeon to qualify the efficacy of BMP-2. It takes someone that is willing to admit that BMP-2 is a pharmaceutical and not a device. Retrospectively, flags were raised back in 2002 when Advisory Panel Members pointed out that 9 out of the doctors that authored the BMP-2 research submitted to the FDA had a financial stake in the product.
Unlike other industry platforms that report the news, TSB must admit, if its open season on INFUSE let's not kiss the ass of two companies that pander to one's commercial needs. This is a golden opportunity for everyone that plays in the biologics marketplace. In all likelihood Medtronic has the capacity to sustain another blow, but this is a great opportunity for every company that competes in this space. TSB wants to know what our blogger think?