On the one hand, setting up the registries that will be charged with tracking the device's performance in the post-market world won't be cheap. On the other, the kindly doctor who will see you now isn't doing it for free, I promise you that. I love how the Sept. 22 letter from the Society of Thoracic Surgeons (Chicago) and the American College of Cardiology (Washington) bleats about the fact that industry-developed registries are “a major expense to industry and creates potential for conflict of interest.”
Well, if it would cost device makers to set up a registry on their own, who's going to finance the registry set up by STS, ACC and their good pals at the Society for Cardiac Angiography and Interventions (Washington)? Maybe these doctor groups will set up a booth in front of Wal-Mart, but somehow I get the feeling device makers will still be on the hook, and the notion that these doctor groups won't make a blessed dime just doesn't smell right at all. So much for your conflict of interest, something for which docs are notorious.
As if that weren't enough to raise the hair on the back of your neck, add the restrictions to usage of the device proposed by the doctor groups, not to mention the cast from the Broadway production of Hair that has to be in the OR for this procedure. According to ACC, this includes (but might not be limited to) primary cardiologists, cardiac surgeons, interventional cardiologists, echocardiographers and imaging specialists, and heart failure specialists.
The only remaining questions is this: “Has the janitor scrubbed, and how much can we bill for his time?”
There are a couple of cliches that address this kind of thing, including “too many chefs and not enough sous chefs.” Pick whichever you like, but there needn't be any hissy fits involving a miffed specialist snapping off a glove and hurling it at a so-called colleague for this to be a study in overkill. Seriously, what could the primary cardiologist or heart failure specialist possibly have to say beyond, “wow, nifty move with that catheter!”?
Frankly, this whole tale tells you a lot more about homo sapiens than about the Sapien. As the television ad for automobile tires used to say, “tires ain't pretty!”
Neither is human nature.