By Gina Kolata

A widely promoted lung operation for emphysema, so expensive that some predicted it would bankrupt Medicare, did not help a group of the sickest patients in a large, ongoing federal study.

The findings from the study will be published in The New England Journal of Medicine on Oct. 11, but the journal made them public August 16 because its editors felt they were so important.

About two million Americans have emphysema.

The disease, almost always caused by smoking, destroys air sacs in the lungs, leaving patients struggling for breath. Medical treatments offer little relief.

But many surgeons have reported that the operation, which involves removing as much as 30 percent of the lung, can greatly improve lung function. Surgeons say the procedure works by removing damaged tissue and giving the healthier parts of the lung more room to expand and breathe.

The operation costs about $60,000.

It is not known how many patients have had the surgery, which came into use in the early 1990's. In 1996, a government survey showed that more than 3,000 had had the operation at 27 medical centers. There are no national records of how many operations have been done since.

The new results are from 140 patients out of 1,033 who have enrolled in the federal study and had their treatment assigned at random, either surgery or medical treatment. The 140 patients, whose average age was 60, were so sick that their ability to force air out of their lungs was no more than 20 percent of normal, and they had extensive lung damage.

Such severe illness means that a person might be able to walk around a room, but could not walk half a block. Almost all needed supplemental oxygen.

Sixty-nine of the 140 patients had the operation but had no improvement in their quality of life.

Sixteen percent died in the month after the operation, as compared with no deaths among study participants who were just as ill but did not have the operation.

But even though the operation is still being studied, many surgeons are selling it to patients because they believe it works. Unlike drugs or medical devices, surgery is not regulated by the Food and Drug Administration.

That means surgeons can offer new procedures without first proving that they are safe and effective, Dr. Make said. It also means that when a new operation seems promising, a market for it can spring up overnight.

That is what happened with the lung operation, medical experts said. By the mid-1990's it had grown so popular that Medicare envisioned soon paying for tens of thousands of operations a year.

But medical experts were concerned, because the positive reports were from surgeons who did not did include, for comparison, a control group of patients who were randomly assigned not to have the operation.

Such uncontrolled studies have often produced misleading results.

In 1996, the Centers for Medicare and Medicaid Services, which is responsible for Medicare, and the National Heart, Lung and Blood Institute agreed to begin a five-year national study that would include such a control group.

And Medicare did something it had never done before. It said it would pay for the experimental procedure only if patients joined the clinical trial and agreed to be picked at random to have the operation or be in the control group. The National Heart, Lung and Blood Institute insisted that surgeons who were participating in the study not offer the operation on the side to paying patients.

People with the worst emphysema have now been barred from the study, but if the operation turns out to help most other participants, Medicare could face a huge bill. About one out of three emphysema patients qualifies for the federal study.

With two million emphysema patients in the country, most of Medicare age, and at the discounted $30,000 price that Medicare pays for the operation, it would cost $20 billion to operate on all who would be eligible.

New York Times August 15, 2001

Dr. Mercola's Comments:

Yet another tragic example of the traditional medical paradigm wanting to use their surgical and drug model for chronic illness. It really does seem hard to believe that intelligent individuals would actually believe that this operation makes any sense. However, hundreds of people have already had the surgery despite the fact that nearly one in five die from it in the first month after the surgery. Interestingly, many of these desperate patients even paid for it out of their own pockets. If the operation had proven successful, the US taxpayer would have had to pay $20 billion dollars to subsidize individuals who freely chose to smoke themselves to a long slow and painful death. I am all for free choice, but it sure does not seem fair that people are not allowed to fully experience the Law of the Harvest: You Reap What You Sow. The corollary is that you don't reap immediately, either good or bad, since it takes a while to grow and bear the fruitful harvest. If you are planting healthy habits you will reap an abundant reward. But if you are smoking and not following the eating plan, you will likely suffer from some less than pleasant diseases. Emphysema is one of those terrible diseases. There are not too many things one needs to do in life, but one of them is to breathe. When your lung tissue is destroyed from smoking, it becomes virtually impossible to do that. So the take home message is stop smoking before this happens. The old "ounce of prevention" is clearly worth more than 20 billion dollars of worthless surgery. Related Articles: Vitamin C May Cut Lung Disease Risk Vitamins Improve Lung Function