Off-label use of laser heart treatment analyzed

"Dr. (Larry) Kessler said the patients were largely unaware that they were essentially subjects in a large, uncontrolled experiment. He called the off-label use of TMR 'doing an experiment without informed consent.'"

--From Gina Kolata’s New York Times story today on transmyocardial revascularization, a laser treatment for chest pain. She reports on a study published in the Journal of the American College of Cardiology that found that about three-quarters of patients who get TMR don’t meet the criteria for which it was approved by the U.S. Food and Drug Administration.