What's a Mother to Do?

In the course of things, clinical trial data, no matter how impressive, are not always able to bring the practitioner to an informed patient-care decision. This is not a revelation to the experienced clinician. We know that all of the things that happen in practice cannot be accounted for within a circumscribed clinical trial. The situation is more complex when a new treatment hits the market. Here, clinical experience is sparse as well, making rational treatment decisions even more difficult. We expect that this problem will be particularly intense with the advent of the new anticoagulants.1 So many kinds of physicians treat so many types of patients and conditions that there are going to be wide gaps between what we know and what we are expected to do. We can take some solace from the fact that contemporary studies register thousands of patients, but the fact is that there are fairly rigid enrollment criteria that homogenize the populations more than trialists and sponsors suspect or care to admit. Thus, when a new drug is released, initial unbridled enthusiasm is followed by sobering disappointment. Harken backs to Osler’s famous reminder, to “use the new drugs now, while they still work.” What is a clinician to do in such a circumstance? The choices are to remain steadfast in the use of old therapies until the question has been addressed in trials or there has been vast clinical experience, or to take a deep breath and jump in. Most of us pursue an intermediate approach of using the new agent selectively for a new indication, taking into account the risks of remaining overly conservative versus being too adventuresome. In the realm of anticoagulation where the stakes are high, most of us tilt toward being circumspect. For example, it seems foolhardy to assume that a new direct thrombin inhibitor would protect patients with prosthetic heart valves when we know that a miscalculation would have grave consequences for the patient. In this issue of the Journal of Cardiovascular Electrophysiology, Winkle et al. relate their clinical experience with dabigatran in patients who had an atrial fibrillation (AF) catheter ablation procedure.2 The investigators are to be applauded