Friday, October 02, 2009

Our New Era of Comparative Effectiveness Research

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.



Anonymous said...

not to nitpick but the article you link to says biosense gave 10 mil, so the gov't is actually picking up 38%!

so 6 years away from having an answer. by that time healthcare may evolve significantly and the answer, while important, may be less critical than policies to control costs that will have evolved while we wait for the answer.

Thomas A. Coss, RN said...

Perhaps to not nitpick even further, those fund committed to this study by companies are likely taken against the companies taxes, thereby reducing their tax burden; the "government" i.e. us, are paying for even more than 38%, but in the end, does it really matter? What matters is that well meaning companies and physicians are pursuing knowledge that can benefit many.

Now you have to ask yourself a hard question. Suppose the Government, as anticipated, slaps a heavy tax upon medical device companies, thereby crowding out the ability to do these kind of studies. Just how are we made better off?

At least these companies are closely in tuned with their clinical customers and the challenges physicians are facing on a daily basis. Or do we believe that the National Institute of Health is best to decided what clinical studies should be done.

DrWes said...


Now you have to ask yourself a hard question. Suppose the Government, as anticipated, slaps a heavy tax upon medical device companies, thereby crowding out the ability to do these kind of studies. Just how are we made better off?

Not sure why but the idea of "having one's cake and eating it, too" comes to mind...

Anonymous said...

i'm pretty sure if it happens to work out that medications are better than ablation, the corporate funding for these types of studies will dry up quickly.
they probably paid all kinds of money to be able to do studies to get fda approval in the first place. now they are paying money to possibly limit their ability to do work. conversely, if ablation is shown to be much better than medications, what will that do to cost of health care short term?

Anonymous said...

How come pharma companies marketing rhythm control or rate control drugs(other arm of the study)are not participating in this trial?

caroline said...

I thought you might be interested in "sitting in on" a panel discussion on CER. there's a video of the meeting here:

Feel free to pass it along to colleagues who may be interested, and by all means leave your thoughts!