Medtronic's Endless Headache

As Medtronic prepares to head into a new fiscal calendar, the potential for additional challenges lie ahead for the once known jewel of the industry. Essentially, growth for the Goliath of the spine industry has been flat across the board.  Wild Bill reported that Medtronic had seen steady growth across most of their businesses and geographies, which was offset by challenging dynamics in the U.S. ICD and spinal markets.  As Wild Bill prepares to hand off the reign of the Evil Empire to Omar Ishrak, oh Omar if only you knew what you were really getting into, the NYT's reported this morning that a new study links spine product, INFUSE, to risk of sterility in men.

The study in question was released Wednesday suggesting that INFUSE poses a risk of male sterility.  This finding is in stark contrast to earlier research by doctors paid by Medtronic who found no connection between the product and a condition that causes sterility.  Now before everyone starts jumping down each others throats, let's get all the facts before the name calling starts.  INFUSE has been widely used and advocated by the surgeon community in spinal surgery since around 2002.  The labeling on this product does note that sterility related complications may be a side effect, but the controversy lies in that Medtronic sponsored researchers published reports attributing the complication to surgical technique and not the product itself.

A study posted Wednesday, on the web site of The Spine Journal by Dr. Eugene J. Carragee urges doctors to counsel men about INFUSE'S risks. Dr. Carragee based his study on 240 patients that he treated with INFUSE several years ago.  The spinal fusion in question is the ALIF.  The sterility complications at issue in Carragee's study affects only men and not women.

The two surgeons who were involved in the original INFUSE trial defended their findings to statements saying that not enough of men had experienced sterility-related complications in their study to statistically link the problem to INFUSE.  The two surgeons that spearheaded this study were Dr. Thomas A. Zdeblick and Dr. J. Kenneth Burkus.  In his web article, Dr. Caragee questioned why Zdeblick and Burkus had not broken out the patients in their study between those who had received INFUSE and those who had not, a method htat he said was a standard way to present a clinical trial result.

In response to Carragee, Zdeblick said the Caragee study was of limited value because it reflected the results of a retrospective look at patients rather than a clinical trial.  Such reports "are notorious for being misleading."  This new study will only add more fire as the intensity and debate surrounding INFUSE continues over having industry financed researchers present study findings in ways that favor the interests of corporate sponsors.  But the question must be asked, IS THERE A BETTER WAY?  How does one subsidize a study, if not by the company that is looking to validate its product's efficacy in the surgical arena?  Whom else does one use, if not those individuals that have the most experience with the product?  If there were "total transparency," would we look at these outcomes with a different lens?  

TSB is not going to pass judgement on Zdeblic and Burkus' findings, but one must wonder, does human nature play a role in enhancing ones outcomes?   Other surgeons have come out with opinions regarding the clinical utilization and efficacy of INFUSE, so is there a rational explanation for these differences?  So in closing fellow bloggers the INFUSE saga continues do we believe the Zdeblicks and Burkus' of the world, or, do we believe the Carragee's, somewhere in between these three parties lies the truth.  Omar welcome to the spine industry, where the show never ends.