The FDA's Gift of Giving

The last few weeks in spine has made it interesting to read everyone's comments regarding INFUSE.  Your commentary has made TSB think about how truly gamed the system is by those spine/orthopedic companies that wield economic power in the industry.  The principle behind any oligarchy is that economic power yields political clout and influence. The obvious companies come to mind, Medtronic, Johnson & Johnson/Synthes, Stryker, Zimmer, Biomet, Nuvasive (Billion Dollar Baby), Orthowreck, and Globus. Don't believe that?  Just walk in a North American Spine Society Meeting. The big boys are situated right at the front entrance, while the ankle biters are hidden in the back near the restrooms, hoping that surgeons looking to relieve themselves will grace them with their presence.  Our society cherishes the idea that all Americans have an equal opportunity to make money.  A rich and privileged class of companies that have consistently used government relationships to enrich themselves in the best of times, and protect themselves in the worst, only to cry out for big government to stay out of their business.  If one truly believes in "free-markets," one understands that our economic system was founded on the notion of fair competition in a free market.   Most of these companies cry like an adolescent when it comes to being held accountable, in many respects believing that they should be treated like their Wall Street brethren, blaming the federal agencies for their inability to generate more revenue by placing restrictions and regulations on innovation, resulting in jobs being exported overseas, and crying for even more deregulation.  Just like the housing market, the spine market is beginning to realize that the days of glory are gone, unless of course you are the industry's Maggie Fitzgerald and are selling futures to the analysts that your company will one day be a billion dollar baby.

So what's the gist of this post.  Considering the rants regarding INFUSE, its clinical efficacy, and  off-label use, no one has still answered the $1 million dollar per day question, did the FDA drop the ball on INFUSE, and were they pressured into making a decision that has potentially hurt a percentage of patients rather than make their lives better? Could someone at the FDA have been influenced by tried and true methods?  Let's face facts, all we hear are the stories and papers that espouse the use of this pharmaceutical, but what about the horror stories?  Many readers and platforms love to skewer the FDA, blaming them for the industry's inability to bring innovation to the marketplace, complaining that there needs to be a relaxing and restructuring of the submission process.  But could this be a scenario where the FDA really failed at what its suppose to do best?  Protect the public?  Is the FDA looking out for our best interest?  And, is it just the FDA, or, have the courts now set precedent?

In 2009, lawsuits on behalf of thousands of plaintiffs with Medtronic heart defibrillator wires, which have been known to be the "shittiest" in the industry and had been know to fracture and potentially send lethal shocks to patients, had been dismissed by U. S. District  Judge Richard H. Kyle on the basis of the Preemptive Doctrine. Undoubtedly, Judge Kyle's background as a Minnesotan, nor, that his son's law firm had previously done work for Medtronic had nothing to do with his decision. The Preemptive Doctrine is based on the Supremacy Clause, which dictates that the federal government in exercising any of the powers enumerated in the Constitution, must prevail over any conflicting or inconsistent state exercise of power.  Does the Preemptive Doctrine then open the door for more devices to slip through the system that are not ready for implantation?  Maybe we should hook up Judge Kyle and his son to one of those defibs, just for shits and giggles to see if they like it? And then there is Wyeth.  Wyeth sold the rights to BMP-2 to Medtronic. Will they be asked to testify and grace the Senate Finance chamber with their presence, knowledge, and experience on how this drug was originally intended for delivery and use? Wyeth could be the key in answering many open ended question about how this product should have been commercially brought to this market.  Pure conjecture would say that Wyeth knows much more than anyone of us know.

So in closing, it will be interesting to see how long the Senate investigation will take.  Will Ishrak call on his buddy Jeff Immelt to pull strings on Capitol Hill, while Medtronic continues to grease the wheels of the Congress and the Millionaires Club spending more money on lobbyists fighting their cause? And who has incurred the cost, or the wrath of the many revisions that took place due to INFUSE growing like wild fire?  The taxpayer?  All for the love of science and medicine, no doubt.    Until then, Caveat Emptor.