October 6th, 2009 by DrWes in Better Health Network, Health Policy, News
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I just finished our first day at the Principle Investigator Meeting for the launch of the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial in Philadelphia today. The trial is a 3000-patient patient trial performed at 140 centers around the world and jointly sponsored by the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and industry (St. Jude Medical and Biosense Webster).
The trial will randomize 3000 previously untreated or incompletely treated patients at high risk of cardiovascular complications in the trial to two arms: 1500 patients to catheter ablation as primary therapy of atrial fibrillation and the other 1500 patients to conventional medical therapy with rate control or rhythm control strategies to determine if catheter ablation is superior to medical therapy at reducing total mortality (the primary endpoint). Secondary endpoints of a composite endpoint of mortality, disabling stroke, serious bleeding, or cardiac arrest will also be studied.
If done properly, this study stands to be a landmark trial for the field of cardiac electrophysiology and has huge ramifications for the treatment of patients with atrial fibrillation. Also, it doesn’t take a lot of rocket science to know that the government will be looking closely at the results of this trial to determine which treatment strategy will receive government funding. Read more »
*This blog post was originally published at Dr. Wes*
September 17th, 2009 by DrRich in Better Health Network, Opinion
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When DrRich left his medical practice nearly a decade ago, he spent much of the next few years as a consultant to certain companies that make implantable defibrillators.
Most of his work was in research and development, and had next to nothing to do with defibrillators themselves, or any aspect of treating cardiac arrhythmias. Rather, DrRich was interested in developing physiologic sensors that could be deployed in implantable devices, and the algorithms that could use these sensors to predict and detect various developing medical conditions (so as to enable early intervention, and potentially prevent said medical conditions from becoming manifest). DrRich considered this work a) interesting, and b) representative of a business model that could potentially flourish within a healthcare system whose chief concern is reducing costs.
And whenever the captains of industry who signed his checks would ask him something about implantable defibrillators, usually seeking his opinion on a proposed subtle variation in some unbelievably complicated programming feature, DrRich’s reply was likely to be something like this: “Sir (or Madam) – I will be happy to study the question you pose to me, as I am working on your dime. But it greatly saddens me to see all this time, energy and talent wasted on adding yet more irrelevant features to a mature technology, in pursuit of a business model that is fundamentally broken.”
To which they would smile indulgently, hand DrRich the document describing the proposed changes, and schedule a meeting to discuss them.
The indulgent smile was in recognition of the fact that DrRich never made a secret of his disdain for the business model embraced by implantable defibrillator companies. The fact that these captains of industry put up with DrRich’s disapproval was a clear indicator that they considered it to be “quaint,” and apparently not worth taking seriously, and that the value DrRich provided in other arenas at least counterbalanced the annoyance of having him criticize their core business every chance he got.
DrRich’s disdain for the implantable defibrillator business model was based on two factors.
First, their business model relies on the artificially high prices the system will pay for their devices. DrRich has discussed this before. While these high prices are not directly the fault of the companies themselves (rather, they are fundamentally the fault of Medicare processes that distort and destroy natural market forces), these companies have now come to rely entirely on this artificial price structure, and have established all their business practices around this high-margin enterprise. The problem is that this high-price model absolutely precludes any reasonable penetration of this life-saving technology into the vast population of patients who might benefit from it. Also, because the price structure is not only artificial but arbitrary, a few simple changes in Medicare processes could abruptly destroy their business overnight.
Second, nobody is really interested in preventing sudden death. It’s difficult to sell any product when there’s no demand for that product, and there is no demand for sudden death prevention. In contrast, most other medical problems have a built-in constituency Read more »
*This blog post was originally published at The Covert Rationing Blog*
