The surgery caught on and Medicare paid for the procedure, explains Cooper, but the agency stopped reimbursing it because the hospitals were not choosing the right candidates for the procedure and were not providing appropriate follow-up care and too many people were dying. As a result, in 1996, the National Heart Lung and Blood Institute in collaboration with the Health Care Financing Administration, the agency that runs Medicare, developed the National Emphysema Treatment Trial. The government pays for the subjects' participation. Cooper's institution originally participated in the trial but quit because he believes patients assigned to the control group should not be denied surgical treatment if they show signs of deterioration as the trial progresses. Cooper compared the trial to the infamous Tuskegee Syphilis study, in which black men were denied treatment for the disease in order to study the course of the disease.
Cooper claims the trial is having trouble recruiting patients because of the randomization.
Dr. Weinmann also said that a randomized trial is essential for determining which treatment is better. If the data were convincing, she said, they could modify the protocols. But others believe the evidence is clear. Dr. Cameron Wright, a thoracic surgeon who is leading a trial at Massachusetts General Hospital, in Boston, which allows patients in the control group to get the surgery if they degenerate, believes that some of the end goals of national trial are wrong. They want to know how many people will die without this.