Assessing the Artificial Heart: The Clinical Moratorium Revisited

Abstract

Viewed in relation to the vast amount of clinical research in the United States, the number of total artificial heart (TAH) implants is so small as to be statistically invisible. And while the results of those implants to date may seem dubious in terms of the recipients' outcomes, theyare in fact very similar to those of many other innovative therapies when they are first tried ondesperately ill patients. Why, then, has the artificial heart been the object and subject of suchextraordinary interest and controversy? It has been the subject of special federal studies, reports, and hearings for 20 years; has been perceived and portrayed as a unique chapter in the annals of human experimentation and therapeutic innovation; has attracted medically unprecedented media attention; and, in the case of permanent implants, has received unusually exhaustive and restrictive regulatory supervision.