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Concern grows over stomach surgery

The number of overweight Americans resorting to stomach-shrinking surgery is rising so quickly that health experts and insurance companies are increasingly becoming concerned about the safety, effectiveness and mounting costs of the operations.
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The number of overweight Americans resorting to stomach-shrinking surgery is rising so rapidly that health experts and insurance companies are increasingly becoming alarmed about the safety, effectiveness and mounting costs of the operations.

While the operations can produce dramatic benefits for very obese people, some hospitals and surgeons may be rushing too quickly to satisfy the surging demand, offering the lucrative procedures without adequate training, experience and support, experts say.

At the same time, the operations, which force people to eat less by reducing the size of their stomachs, are being performed too commonly on people who might be able to lose weight through diet and exercise, particularly younger adults and teenagers, they say.

Alarm has intensified because of scattered reports of severe complications and deaths around the country. In Massachusetts, for example, a special panel has begun assessing the procedure for state health authorities after several patients died following surgeries.

Citing uncertainty about the safety of the procedures and lingering questions about their long-term effectiveness, a growing number of insurance companies have begun balking at paying for the operations, which cost the nation close to $3 billion a year.

To try to resolve some of these issues, the National Institutes of Health has launched a five-year, $15 million research project to gather data about the operations, identify patients most likely to benefit and learn more about how they work.

In the meantime, the American Society for Bariatric Surgery, which represents surgeons who perform the procedures, has established an independent nonprofit corporation that in June will begin identifying "centers of excellence" deemed most qualified to do the complicated operations. The group is also gathering scientists at Georgetown University next month in the hopes of reaching a consensus on the risks and benefits of the treatment.

The rising concerns about stomach surgery illustrate the uncertainties that can occur with the emergence and proliferation of new surgical procedures, which often do not undergo the same level of testing, scrutiny and government oversight as new drugs or medical devices.

In addition, the debate over whether insurers should pay for the surgery illustrates the tension that is mounting as the obesity epidemic adds billions of dollars to the nation's medical bill. Millions of Americans already meet the criteria for the operation, which costs about $25,000, and millions more are expected to join those ranks as obesity rates soar.

"Insurance companies are feeling the first pressure of the increasing costs of the rising obesity epidemic from this procedure," said Roland Sturm, who studies the economic impact of obesity for the Rand Corp., a private research organization. "If we look into the future, the rising obesity epidemic will continue to have tremendous effects on health care costs. It's an astonishingly big factor. And it's only going to get bigger."

As the number of obese Americans has soared and new, less invasive laparoscopic versions of stomach surgery have been introduced, the number of people undergoing the operations has skyrocketed, spurred by the lack of effective alternatives and by celebrity patients such as NBC's "Today" show weatherman Al Roker. The number of surgeries shot up from about 16,000 a year in the early 1990s to an estimated 103,000 in 2003 -- and is expected to approach 150,000 this year, making it one of the fastest-growing procedures. Many centers report long waiting lists.

Surgeons perform several variations, but all involve sharply restricting the size of the stomach, either by stapling most of it closed or sealing it off with elastic bands and bypassing portions of the digestive system to reduce the number of calories that can be absorbed. The procedures can enable severely obese people to lose hundreds of pounds, alleviating disabilities and preventing, even sometimes reversing, serious health problems, most notably diabetes and high blood pressure.

But the operations are complicated, and patients are prone to life-threatening complications, including bleeding, blood clots, leakages and infections. Even if they have no serious complications, patients often experience unpleasant side effects, including a phenomenon known as "dumping" -- nausea, vomiting and diarrhea -- when they overeat. As a result, patients have to undergo intensive counseling and monitoring to make sure they eat appropriately and do not suffer nutritional deficiencies.

"It's extremely difficult surgery," said Paul Ernsberger, an associate professor of nutrition at the Case Western Reserve University. "Even when it's done perfectly, there can be a lot of problems."

According to federal guidelines issued in 1991, the procedure is supposed to be performed only on people who are at least 100 pounds overweight -- and primarily on those who are also suffering severe health problems because of their weight. While most people getting the procedure probably meet those criteria, there is concern that increasing numbers of people who weigh less are also undergoing the procedure.

"Many people who are not morbidly obese are trying to get this procedure. It's rapidly viewed as the answer to obesity, and more and more say, 'I can get surgery done as an answer to my problem,' " said Barry Schwartz of Blue Cross and Blue Shield of Florida. "We've actually seen a couple of patients who decided with their doctor that they would eat more so they could qualify. It's perverse."

Schwartz and other critics say the surge in popularity is enticing some hospitals and surgeons to try to capitalize on the interest.

"Many hospitals and physicians see this as a cash cow," Schwartz said. "We've seen surgeons who did a weekend course and then started doing this high-risk surgery. Make no mistake about this: This is high-risk surgery. The quality of service is going down, and the risk to patients is going up."

Some researchers also question the reliability of the data on the safety and effectiveness of the procedures.

"We don't have quality longer-term studies that give us good data on long-term safety and effectiveness," said Frank Lefevre, an associate professor of medicine at Northwestern University who evaluated the procedures for the Blue Cross and Blue Shield Association.

Already alarmed by skyrocketing health costs overall, a number of insurers, including Blue Cross and Blue Shield of Florida and Nebraska and Humana Inc., are discontinuing coverage for the operations.

"We've had an explosion in obesity and an explosion in the demand for quick fixes, if you will, to the problem of obesity," said Helen Darling, president of the National Business Group of Health, which represents major corporations on health issues. "It's beginning to dawn on insurance companies and employers that even after the surgery, there are a lot of big expenses and a lifetime of care. Many employers and insurance companies feel this is just not affordable today."

Some experts liken the situation to what happened with bone marrow transplants for breast cancer in the 1990s, when terminally ill breast cancer patients clamored for the procedure until carefully designed studies finally showed it did not save lives.

"Whenever a new technique seems to be providing benefit, it tends to proliferate," said Jonathan Moreno, a University of Virginia bioethicist who studies surgical procedures. "Oftentimes, these things gradually become the standard of care without going through any studies."

But proponents of the surgery say the procedures have undergone extensive study and have clearly shown to help patients, enabling many to shed one-third to one-half of their excess body weight or more and keep it off for many years.

"I think these insurance companies may be using this as an excuse to avoid their responsibility. They think they can get away with this because of the prejudice that's out there for people who are obese," said Harvey Sugerman, president of the American Society for Bariatric Surgery. "I think it's a travesty."

For patients who have been suffering for years and been unable to lose weight despite repeated diets and exercise regimens, the operations are life-altering, he said. "It's an amazing operation. It's hard to describe how helpful it is to these patients. You have a patient who comes in who can hardly breathe, their legs are all swollen up, they have diabetes and high blood pressure, and they come back to you in three months, and they're all gone. They feel wonderful."

While the procedures can be dangerous, Sugerman and others said that for appropriate patients, the benefits clearly offset the risks, which are on a par with the dangers of operations for other life-threatening conditions involving seriously ill patients.

"It's actually surprising how good the results are," said David R. Flum, a University of Washington surgeon. "If you look at all the options available for the treatment of obesity, we know one thing for sure: Non-surgical approaches, even the most radical approaches, even the most aggressive non-surgical approaches, are horribly ineffective."

But Flum and some other experts acknowledge the complication rates are unclear. Most published studies have involved highly experienced surgeons operating on ideal candidates. Some research indicates the complication and mortality risks may be much higher than reported, especially as less experienced surgeons begin performing the procedures on a wider spectrum of patients.

"We really don't know what's happening in the real world, and there's a lot of reason to be really worried about that," said Flum, who is helping evaluate the procedures for the NIH consortium. "In the real world, surgeons may do many fewer patients per year. They are learning the procedure. Or picking patients who may not do as well. A lot of things have got us worried."