Experts Find Dangers in Emphysema Surgery
A pioneer in the surgery, Joel Cooper, MD, downplayed the findings. He said they were predictable because patients reported in the latest findings suffered from disease that was widely spread around their lungs. He said they were bad candidates for the surgery in the first place.
Cooper said his team dropped out of the five-year study in 1997 over this and other disagreements, including a condition that all participating surgeons stop doing the surgery outside the study.
He also said administrators at the federal Medicare program for the elderly, which is funding the study, are seeking justification to limit, delay, or deny coverage for the surgery, which typically costs from $25,000 to $40,000.
"Medicare has used the trial for its own purposes," said Cooper, a lung surgeon at Washington University in St. Louis.
An official at the Centers for Medicare and Medicaid Services said the agency didn't interfere with the scientific decision making. The official spoke on condition of anonymity, which is agency policy.
Gail Weinmann, MD, project officer for the study at the National Institutes of Health's Heart, Lung and Blood Institute, said surgeons agreed to forgo surgery outside the study because they saw a need for systematic research.
"There was a concern about the spread of the procedure so quickly, and that it could be doing harm," she said.
The surgery was first tried more than 30 years ago with disastrous results. Improvements in anesthesia, surgical methods and postoperative care revived it in the 1990s. It is based on the idea that smaller, but healthier lungs can work better after the operation.
The technique became so widespread in recent years, with around 8,000 operations now performed, that researchers had trouble finding patients for the study. They said some candidates feared they would be assigned to comparison groups taking normal treatment, which includes diet, exercise and drugs.
In the latest findings, though, none of the 70 patients in the normal treatment group died within a month. The surgery left 11 of 69 patients dead.
Over three years, surgery patients were four times more likely to die than the others. Also, surgery survivors gained only limited benefit in better breathing or quality of life.
Weinmann defended the decision to operate on patients included in the latest findings, saying they were an important group to study and there is little medicine can do for them.
Lung specialists outside the study said patients with broadly spread disease were suspected to be relatively poor candidates for the surgery. However, they said the findings are valuable because they underscore the potential danger for some patients who may be overly eager for the surgery.
"In these patients ... someone needs to have a serious talk with them," said Jeffrey Drazen, MD, a lung specialist who is also editor in chief of the journal.
"My guess is that most physicians will heed this warning," added Norman Edelman, MD, scientific consultant for the American Lung Association. -->