There's an opening scene in the documentary It Might Get Loud, where Jack White, the infamous maniacal and passionate guitarist is driving down a country road in Franklin Tennessee with l'il Jack in the back seat and states, "technology is a big destroyer of emotion and truth. Obviously it makes it easier for you to get home sooner, but it doesn't make you more creative as a person. That's the disease you have to fight in any creative field, ease of use. "
On July 31st, the Courier Journal reported that two Norton Healthcare surgeons form Louisville, Kentucky were criticized by The Spine Journal (TSJ) for allegedly under reporting or failing to mention side effects from INFUSE and Amplify. TSJ said that John Dimar II and Steven Glassman were among surgeons that under reported or failed to mention side effects including cancer, male sterility, unwanted bone growth, and nerve damage in 13 papers published between 2000 and 2010 that were sponsored by Minneapolis based Medtronic. The 13 papers in question concluded that INFUSE and Amplify were at least as safe as bone grafts.
TSJ is the official journal of the North American Spine Society (NASS). In a statement NASS concludes that, " it harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research, concluding that the adverse effects were 10 to 50 times greater than what was reported. Three of the thirteen papers were authored by Dimar II and Glassman, whom declined to be interviewed for the article.
The paper in question was authored in 2009 by the two Louisville spine surgeons and four co-authors regarding a 463 patient trial of Medtronic's Amplify, saying the study failed to stress a link to cancer. Granted Dimar II and Glassman were each paid royalties of $2.4 million dollars, but that was for top selling products that they had helped to develop. Several years ago Medtronic paid a fine of $40 million dollars to settle a claim that they had paid surgeons to use their products. The obvious argument will be made by some of our bloggers that this is old news. Contrary to those beliefs, one must ask the question, has innovation in technology taken away the art of surgery? Innovation and emerging technologies are important. But, where does one draw the line when it comes to a craft like surgery? Have training programs and surgeons gotten away from what made the art of surgery a great profession, the ability to transfer knowledge to one's hands and potentially enhance the patient's quality of life? Has BMP become the victim? Is BMP the really the root cause of the controversy that surrounds Medtronic and its relationships, or is it managing the behaviors inherent to our own human nature? By not being forthright in their past findings, not only are these surgeons performing a disservice to the public, they are leaving a lingering cloud hanging over their reputations? Maybe reputation really doesn't matter or does it?
All one has to do is open a copy of the original INFUSE training manual to understand the concerns that were expressed in the administration of the product. Clearly, there were caveats. Medtronic, as usual, will cooperate with the on going investigation by the Senate Finance Committee by turning over the appropriate documents in question, but in the end will they modify their behavior when a $40 million dollars fine is far less than the profits made on the commercialization of the product? Industry insiders will argue that the FDA and big government are inept at designing an acceptable pathway to commercial use, and at times arguably so, but what happens when there is intent to obfuscate the truth? TSB and its readers do not need to take sides in this ongoing debate, the exercising of orating in a public forum can be left up to those that are the gatekeepers of this profession, the surgeons. It will be interesting to assess the climate at NASS this year, who knows maybe something good will come out of this, or, maybe like Jack White says, it comes down to convenience and ease of use. TSB wants to know is INFUSE the victim or is it the culprit, you be the judge.