By Ray Downs
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Cooper was asked to serve on the initial advisory committee charged with designing a study that would prove, once and for all, whether lung-volume reduction actually helped people. If the surgery did help emphysema patients, the study would also determine how broad a group of patients it helped, make the risks and benefits of the procedure clearer and estimate the total cost of lung-volume-reduction surgeries to Medicare and private insurance plans.
On the advisory committee, Cooper argued that, in fairness to patients, Medicare should pay for the operation for those patients that everyone agreed were likely to benefit from the operation whether they chose to participate in the study or not, as long as it was done at an approved medical center, so that their participation really was given freely and not the result of financial coercion. HCFA refused.
Then Cooper said the study should at least have 'compassionate crossover,' which is a feature of drug trials. By the time a drug or device undergoes a large clinical trial, small trials have indicated that it is effective. The idea of compassionate crossover is this: When a large trial starts, if someone in a control group who was randomly denied the new treatment starts to deteriorate rapidly, doctors can show compassion to that person by offering the option of getting the treatment, of "crossing over" from the control group to the test group. Cooper wanted patients in NETT to have the same opportunity if their health went south. He didn't get it. Other trials, such as the Canadian and Italian lung-volume-reduction studies, have it, but Medicare patients in the U.S. would be denied that option.
Cooper, who had applauded Medicare for taking a step back in January 1996, saying its decision to halt funding "probably saved lives," now found himself on the outside as the parameters of the emphysema study became clear. He quit the advisory committee, and he didn't go quietly, either. The surgeon -- one of the world's top lung docs -- says the study is flawed and that HCFA is primarily motivated by a desire to save money. He has even criticized fellow surgeons who are participating in NETT, accusing them of acting unethically by agreeing to deny treatment to patients who may benefit from lung-volume reduction.
"There is nothing else these patients can be offered, yet we are to deny half of them this treatment, without any provision for patients who deteriorate or might be ideal candidates for it.... That's why I left the trial," Cooper says.
His earnest defense of lung-volume reduction is to be expected, given that he pioneered the procedure. He insists, however, that he has no objection to a randomized controlled trial "as long as it is not coercive, as long as the patient can choose to enter or not enter. When Medicare patients are told this is the only way to get the surgery, that is coercive."
He says Medicare's emphysema trial confuses two distinct things: how an insurer decides what to pay for and how scientists validate a procedure. "Lung transplants were covered early on by insurance, when there was still a lot of important data to be collected, as there is with any new procedure," he says. "You don't wait until you've written the last chapter to decide coverage."
But a more fundamental issue has divided surgeons. Cooper complains that the study forces participating surgeons and hospitals to lie to patients and, if they fall into the control group, to deny them the procedure that can significantly improve their health.
Given the high mortality rate for very sick emphysema patients -- 40-50 percent die within three years -- many of the study participants who are refused surgery will be dead before the trial ends, Cooper notes.
Other surgeons and their institutions refused to participate in the study for the same reason, including Fischel at Chapman Medical and Dr. Thomas Egan, director of the lung transplant program at the University of North Carolina at Chapel Hill.
"I was at (trial) meetings where every doctor criticized the randomization of half the people to medical care and the exclusion of compassionate care," says Fischel, but the study organizers refused to budge. He followed Cooper off the advisory committee. Egan explains why he refused to participate in NETT: "We felt it unethical to randomize patients who are good candidates for surgery, given that there is no other effective remedy for emphysema."
Indeed, so many surgeons have objected to the study parameters that last month, the American Association for Thoracic Surgery sponsored a debate at its annual meeting on whether Medicare's study is necessary and broadcast the debate over the Internet for surgeons around the world to see.
Despite the controversy, 17 hospitals, including St. Louis University Hospital, are participating in the study. Initially, those hospitals planned on enrolling 4,500 patients in the trial and tracking them into 2003. But the prospect of signing up for the trial and still not getting treatment was too disappointing for many would-be volunteers, so the study coordinators lowered their patient goal to 2,500. Enrollment still lagged, so Medicare resorted to hiring a PR firm to promote the trial. The total number of patients now taking part is 800.