With politicians and employers debating ways to tame the explosive growth in health care costs, such treatment stands out as another potentially budget-straining medical commitment.Just what we don't need. Imagine stifling the iterative process that is occurring worldwide to get a better handle on this procedure, just because the FDA can't regulate what tools are used.
“This is one of those areas where the practice of medicine has moved faster than the approval process,” said Daniel G. Schultz, head of the Center for Devices and Radiological Health at the Food and Drug Administration. “This is very high on our list of areas that need concerted attention.”
Dr. Schultz said the F.D.A. would soon schedule a public meeting with medical and industry experts to discuss what is known — and still needs to be known — about the welter of drugs and devices now being used without approval to treat atrial fibrillation.
The field of electrophysiology has a history of far-exceeding regulatory capabilities in the bureaucracy of government. Look at radiofrequency catheter ablation. If we hadn't moved from DC shock to radiofrequency energy sources, many, many more people would have been harmed during catheter ablation procedures. Doctors did this because it was safer for patients and less anxiety-provoking for them during the procedure - not because of governmental regulations.
To think that doctors are not keenly aware of the risks involved with this procedure is ludicrous - we spend far too many (unreimbursed) hours in the lab to think otherwise. Believe me, none of us are proud of the 25-30% recurrence rate seen with this procedure, none of us enjoys the long procedure lengths nor the procedural risks involved, but collectively many believe that we should be able to eventually improve on the technique and therefore, the time and expense of the procedure. Like anything new, there is a learning curve. Catheter ablations for simple accessory pathways used to take four to six hours - now they take one to two. Those who do atrial fibrillation procedures are doing them because, not uncommonly, it works when nothing else has worked before for our patients. And there are real benefits to the patient if it works. Finally, doctors have recognized the need for mortality trials to evaluate outcomes (e.g., the RAAFT Trial and the NIH-sponsored CABANA trial).
So please, FDA, let us do what we do best. After all, it's still a work in progress.
PS: More from the NY Times regarding their recommended centers:
Because the procedure is a difficult one, success rates often track the experience of the doctors doing it. But with new technology and techniques constantly being introduced and doctors occasionally moving, patients should look further than the hospital’s track record in deciding where to turn. In addition, there are cardiac centers in France, Italy and India that have performed the procedure more often and charge significantly less.I wonder if the author of this piece considered the limitations of overseas care, like limited legal and medical recourse should complications arise.