Thursday, December 29, 2005

Atrial Fibrillation and Conflicts of Interest

Man, lots of interesting read from the Wall Street Journal about the relationship of the Cleveland Clinic and their investigators failure to disclose conflicts of interest with their patients.... Big centers like this can leverage their name for professional and even personal gain it seems. There are lots of smart docs out there looking for ways to develop equity in the field of their expertise, but they HAVE to disclose this relationship. The technology with Atricure is cool, tho' (uses a scissor-like clamp to burn tissue between the two blades using a bipolar application of radiofrequency energy during either open chest or "minimally" invasive "keyhole" cardiothoracic surgery to place insulating lines in the atrium to fix atrial fibrillation). I understand the surgeon's enthusiasm for the technology - but it still doesn't get these docs off the hook for non-disclosure. These are big boys in the big leagues. They took lots of tests and checked LOTS of boxes on standardized tests correctly to get where they are.... the "oops, I checked the wrong box" excuse just doesn't fly.

I actually worked with Mike Hooven (now"Chief Technical Officer" (but the real brains)) of Atricure which was a spin off from his first venture in bipolar scissors for minimally-invasive vein harvesting for coronary bypass grafting, Enable Medical) when I was in Cincinnati Ohio about 5 years ago. Atricure is now public and Mike has made a few zillion bucks, I'm sure. My hat's off to him. Mike's one smart "engi-nerd".... but I left Cincinnati for personal reasons (the medical climate there is tough, to say the least: too many hospitals, not enough patients/businesses) and was surprised to see all this! But the story really isn't about Mike, it's about the relationship of major centers taking stake in a company and "researching" and "teaching" without disclosing to the patient's or community to whom they teach (like fellow docs). Hmmm, seems the course at The University of Oklahoma Health Sciences Center Cardiac Arrhythmia Research Institute on "Minimally Invasive Surgical Ablation for Atrial Fibrillation" recently scheduled for 1 Feb 2006 was recently "rescheduled" after the Wall Street Journal piece appeared... Atricure, I'm sure, was to play prominently in the meeting.

Here's the problems in a nutshell:

The Cleveland Clinic has been an advocate of heart surgery with a device from AtriCure Inc. and has done the operation on 1,247 patients while having undisclosed ties to the manufacturer.
Among them:

A venture fund the Cleveland Clinic helped set up and put money into invested in AtriCure.

The Clinic's CEO (Cosgrove) helped manage that fund and invested in it himself.

The Clinic's CEO (Cosgrove) sat on AtriCure's board.

Cosgrove developed a device AtriCure plans to market, which would bring him royalties.

Another Clinic doctor, who used the device and reviewed it favorably in publications, was a paid consultant to AtriCure.

It might be best to let the dust settle a bit before having that conference....


PS: I recently updated my bit on atrial fibrillation with a few more figures. Hopefully it will help out folks trying to sort all the incredible information out there. If it's too technical, let me know. I can clarify if need be. The point is to take yet another approach to the discussion and evaluation of afib that keeps the patient first.... Hmmm, an interesting approach these days....

PPS: Oh, for purposes of disclosure, I am on the Speaker's Bureau for Medtronic, Inc. :)


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Anonymous said...

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