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.
With our current climate of health care reform, one would think that this is the kind of trial the government would want to fund and fund well. After all, the Institute of Medicine labeled (pdf) the treatment of atrial fibrillation it's number one "priority topic" to study.
But the truth is: this trial never would have seen the light of day if it weren't for industry. Note that St. Jude Medical paid $20 million and Biosense Webster paid $18 million toward the trial, while the government could only foot 35% ($18 million) of the costs for the trial. Some will consider this an "efficient" use of government funds. Others will point to the government's new paradigm for requiring significant industry sponsorship to fund their comparative effectiveness research (CER) trials as opening the potential for the development of "pay to play" relationships to develop between government and industry. One only has to look to the FDA's recent challenges at separating themselves from industry influence to see the potential for conflict.
Further, despite the government's enthusiasm to proceed with CER of this fashion, every investigator I spoke with today, without exception, felt the project grossly underestimated the costs required to perform the study at their center. While this will certainly delay enrollment of patients into this trial, it also serves as a harbinger for the penurious nature of future government funding for comparative effectiveness research.