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Beneath Cooper's concern about coercive pressure on Medicare patients lies a distrust of Medicare's motives.
To justify its study, Medicare had to cast doubt on previous studies of lung-volume-reduction surgeries. Its researchers did that by mixing results from Cooper's staple procedure with results from other discredited lung-volume-reduction procedures and by mixing results from hospitals equipped to care for very sick lung patients with results from those that were not, instead of separating cases on the basis of various criteria to see what worked best. Even Naunheim concedes Medicare "mixed apples and oranges," but he adds that this should not invalidate the current study, which will yield a lot of new information about emphysema in addition to whatever is learned about lung-volume reduction.
"I think we are going to learn a lot from the study," agrees Egan, a critic, "but I'm not sure we couldn't have learned just as much from studying patients who were operated on vs. those who weren't without limiting access to the procedure."
The government official overseeing NETT, Dr. Gail Weinmann, project officer at the National Heart, Lung, and Blood Institute, now admits that mixing together the results of different procedures, including one in which physicians burned the exteriors of lungs with a laser, was not a fair way to assess the effectiveness of Cooper's lung-volume-reduction surgery. "There were an awful lot of patients who underwent the laser surgery," she says, but most doctors have abandoned this procedure, and it's not included in the emphysema trial.
If the people running NETT concede that data were manipulated to justify the study, Cooper wonders, can they be trusted to honestly analyze the study results? The incentive to declare the treatment a failure grows with each month that Medicare refuses to pay for it. By the time the study is scheduled to end, hundreds of thousands of emphysema sufferers eligible for lung-volume-reduction surgery since the payment ban took effect will have died. "How can they justify those deaths without a conclusion that (the surgery) doesn't work?" he asks.
Such distrust cuts two ways.
Piantadosi dismisses most previous surgical research on the operation as biased. "You can't rely on surgical practitioners to recognize potential pitfalls (in their research procedures)," he says. "Surgery has no culture of evidence-based research.... Surgeons traditionally have shown respect for elders and experience and a hostility to the scientific method."
Piantadosi says bad outcomes demonstrate that surgeons didn't know who could be helped by the operation. "All this stuff about surgeons' thinking they knew who would benefit was not true. They did not have good judgment." And he calls the supposed difficulty in defining selection criteria and in training a surgeon to properly select patients for the procedure "surgical bullshit."
Naunheim presents himself as the bridge-builder between the two sides. Both sides are right from their own points of view, he says. "It is like a glass being half-full or half-empty." He is participating in the study, then, to show the government that lung-volume-reduction surgery benefits not some individual patients but the population as a whole so that Medicare will restore funding for the operation, "hopefully in another one to two years."
Cooper says it's inexcusable to have patients wait even that long, or die, particularly because there is no disagreement that the operation helps some patients. He says Medicare should restore funding for the procedure, at least at hospitals with the capability and track record of handling lung transplants, such as Barnes-Jewish. And Medicare should redefine the parameters of its emphysema trials to permit compassionate crossover -- allowing surgeons to operate on rapidly deteriorating study participants. Both steps, he says, could be taken immediately.
Meanwhile, emphysema patients still wait to exhale. How many could benefit from lung-volume-reduction surgery? Nobody knows for sure. Cooper puts the number at about 200,000; Naunheim says the operation has the potential to help twice that number.
The fact that many people would benefit is no longer in question -- except, it seems, to Medicare.
Two years after his operation, Jim Farris is off oxygen and works two days a week as a maintenance man at a church. He washes windows, sweeps and vacuums, keeps the air conditioning running and even hefts 50-pound bags of cement. He walks three miles three times a week and exercises his arm and chest muscles on Nautilus machines. And he's driving.
"I still have emphysema, which is a progressive disease, but with surgery, exercise and not smoking, I don't know how long I can last. No one else knows, either. I might now live out a normal life span, but if I die tonight, I've had two great years. Would I do it again? In a minute."
Though his air capacity has fallen slightly -- down to 55 percent of normal compared with 63 percent six months after the surgery -- "that is still nearly three times what it was," he says.
Jim's improved quality of life isn't the only good news.
On Feb. 23, an administrative-law judge in Kansas City heard evidence on the Farrises' Medicare appeal. Twelve days later, Judge Gary Lowe ruled entirely in the Farrises' favor. In his opinion, Lowe wrote: "The record clearly demonstrates by substantial evidence that this procedure is not experimental, is well recognized in the medical community and was clearly successful in this particular case." He concluded that the procedure was both reasonable and necessary under the law and ordered Medicare to pay the bill.