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The unwillingness of patients to volunteer is an indication of the study's flaws, Cooper says.
There is another problem with NETT, though. Cooper says he has been shocked to see emphysema patients who could not possibly benefit from lung-volume reduction randomly picked for the operation. Denying patients necessary medical care is unethical, says Cooper, as is operating on patients who can't be helped by the operation, only hurt. Therefore, he says, those surgeons who are participating in the study are acting unethically.
"I don't know how they can look at themselves in the mirror."
The top St. Louis investigator in the Medicare study doesn't have a problem with mirrors or sleeping at night. But Dr. Keith Naunheim, the 47-year-old chief of cardiothoracic surgery at the SLU Health Sciences Center, insists critics are flat-out wrong about the study: "I don't think it's unethical."
With his TV-star good looks and gentle demeanor, Naunheim is an ideal spokes-man for surgeons participating in the emphysema trial. It probably doesn't hurt that he was trained by the Fleishman-Hillard public-relations firm on handling press interviews. His voice radiates compassion and humor, and he even chuckles a little when asked about Cooper. "One thing about Joel is that when he gets on a roll, he is convinced that he is 100 percent right. A couple of months later, when he has had a chance to think it over, he might change his mind, but he is still convinced that he is 100 percent right."
Naunheim says that in his objections, Cooper presumes that the patients in the study who will be denied treatment would all benefit from the surgical procedure. And that's not a sure thing. No one can say for certain that the operation will help any particular patient, Naunheim says, because "five out of 100 patients die from the operation, mine and Joel's."
The point of the study, Naunheim adds, is to better identify candidates for lung-volume reduction and balance other important issues, such as a patient's quality of life after surgery. And one can't identify who is a good candidate without having cases where the surgery doesn't work.
"We don't know, on balance, what the cost will be to the population on whom we are operating ... what the cost is in morbidity and human suffering in order to get 10 patients who do very well. How many died? How many are on a ventilator?"
The financial question is important, too, Naunheim adds. "Every doctor, from an ethical standpoint, has to look at his patient and say, 'I will do the best for you.' If making an emphysema patient better costs $100 million, perhaps my job as a doctor is to say, 'Damn the money -- I will do it.' But can the country afford that kind of outlay of cash? Obviously not. There has to be time to look at the global perspective," which, he says, is what Medicare is doing.
Naunheim does admit, however, that the emphysema study is much more controversial than the operation it is designed to evaluate. "I don't believe there is a great deal of dispute that lung-volume-reduction surgery is beneficial in certain patients," he says. "The real questions are, who will benefit, for how long, and is the benefit worth it?"
That general agreement that the surgery does help some patients is exactly Cooper's point, however. Ethically, he says, those patients should be given a choice: If they want to participate in the study, fine. If they don't want to be in the study but want the surgery, that should be fine, too. And, Cooper says, it's unethical for doctors to withhold that choice from patients.
That view is bolstered by medical ethicists who aren't involved in the study. "The desire for clear knowledge is trumping the desire to help patients," says Dr. Griffin Trotter, a professor at the Center for Health Care Ethics at SLU and a practicing physician. "If there is no clear reason someone will be helped by the surgery, it is unethical to put them in. The public should be concerned about this. The study may be well designed from a purely didactic point of view, but it's poorly designed from an ethical point of view."
Cooper forcefully argued the ethical issue during the discussions to launch the study. To help settle the matter, says Piantadosi, the study's clinical coordinator, a panel of ethicists was appointed, and they ruled that surgeons who believed in the surgery could ethically participate in the trial if they had "equipoise," meaning that they believed the surgical community was split over whether the surgery was valid and they respected those differences of opinion -- sort of an "embracing diversity" program for scientists. But even Piantadosi admits surgeons were near unanimity on whether lung-volume reduction helped some emphysema patients. And, if that was the case, there was no real equipoise -- that is, no real division within the surgical community about the value of the procedure.
Both Cooper and Naunheim say lung-volume-reduction surgery helps some people. They both say more study is needed to determine how long the benefits of the surgery last and how broad a group of people it can help. So, what's the difference? Why does one participate in the study and the other criticize it?