ARE SURGEONS TOO CREATIVE?

By Christine Gorman

James W. Henry, 78, of Clarendon, Arkansas, is sure he found a miracle. For 30 years, the retired postmaster suffered from emphysema caused by smoking. Even though he gave up cigarettes in 1962, Henry's condition kept getting worse. The emphysema had created so many permanent blisters in his lungs that he could barely cross the room without gasping for air. So when Dr. Joel Cooper of the Washington University School of Medicine in St. Louis, Missouri, told him about a radical new idea--cutting out the useless pieces of his lungs to give him more room to breathe--Henry jumped at the chance to be Cooper's first patient. Now, two years after the surgery, he plays golf, rides a stationary cycle and walks a mile every day.

Sylvia Stanton Sellarole, 61, of Redlands, California, was not so lucky. For five years the registered nurse had suffered the uncontrollable tremor and halting steps characteristic of Parkinson's disease. But her hopes soared in 1993 when she heard Dr. Robert Iacono of the Loma Linda University Medical Center speak at a medical conference about practically curing the degenerative nerve disease in hundreds of patients. Iacono's unusual solution involved surgically destroying a tiny portion of the brain that some doctors think becomes overactive during the course of the illness. At first the operation on Sellarole seemed successful. Then she became paralyzed on her left side, forcing her into a wheelchair. Sellarole and her new doctors believe that Iacono destroyed too much of her brain tissue, thereby crippling her. The surgeon has maintained that her condition is unrelated to his operation.

These two stories, with their radically different outcomes, illustrate both the enormous potential and the terrible risks of experimental surgery. They also reflect the special status accorded surgeons. Had either doctor been touting a new medicine instead of a new type of operation, the U.S. Food and Drug Administration would have insisted on research trials, first on laboratory animals and then on human volunteers, before the surgery could be tried on large numbers of patients.

By longstanding tradition, though, there are no comparable standards for new operations. In part that's because surgeons must be able to improvise. They never know precisely what they're going to find until they actually get inside a patient--and when they run into something unexpected, they have to deal with it quickly. In deference to surgeons' being under constant pressure to practice creative medicine, their colleagues have granted them unusual latitude in trying innovative procedures. And regulators have gone along--a policy that has come under increasing criticism. "It's a huge gap in the system," says Arthur Levin, director of the Center for Medical Consumers in New York.

But while this freedom has resulted in plenty of new and highly effective operations, it can also create unhealthy competition. Surgeons know that if they don't offer the latest techniques in the operating room, they risk losing a patient to others who will. Unless a procedure calls for a new piece of medical equipment and thus falls under FDA jurisdiction--like a new laser to correct nearsightedness that is currently awaiting the agency's approval--it can become widespread without ever being definitively proved to be safe or effective.

Sometimes it turns out to be neither. That's what happened with a promising new eye operation. Each year 6,000 older Americans experience a sudden loss of vision that ophthalmologists suspect is caused by swelling around the optic nerve. In 1989 some eye specialists in Philadelphia used surgery to release that pressure and reported their success in 14 patients. Soon surgeons were performing 1,000 such procedures each year. It wasn't until 1993, however, that researchers undertook a scientifically controlled study of the technique. The results were surprising.

As expected, nearly a third of patients who had the operation did regain some sight. But people who didn't have the procedure got their vision back too--in even greater numbers. Not only was the operation less effective than doing nothing at all, but it evidently hurt some patients' chances to recover on their own. In January of this year, soon after the study was completed, the National Institutes of Health issued a clinical alert calling on doctors to abandon the operation.

Unfortunately, there is no simple way to encourage innovation and at the same time protect patients from ineffective procedures or overly confident surgeons. Insurance companies and managed-care organizations, which are increasingly militant about cost containment, have come down firmly on the conservative side. After decades of going along with doctors' wishes, they now generally deny reimbursement for experimental surgery. If this attitude had prevailed in the days when surgeons first started to replace heart valves, implant artificial hips or repair congenital birth defects, these important and now routine procedures wouldn't exist.

Even without the insurance-company roadblocks, today's surgical pioneers face greater challenges than earlier generations did. The easy fixes have, for the most part, already been made. Surgeons therefore find themselves attempting to treat ever more difficult conditions. Washington University's Cooper, for example, is only one of several physicians who are experimenting with ways to deal with advanced emphysema, which is otherwise untreatable. "Where do you go to try this?" Cooper asks. "There is no animal model for emphysema to see if it works." A human being must serve as the first guinea pig.

There are ways to assure quality control, but they are coming under greater pressure than ever before. All hospitals have an institutional review board that examines a doctor's proposal for a new procedure and makes sure he or she publishes the results. That process exposes pioneering surgeons to the criticism of their peers. "There are checks and balances built into the system," says Dr. Robert Replogle, vice president of the Society of Thoracic Surgeons. "You can't just go off and do some cockamamie thing without some research."

There is nothing, however, to stop a surgeon from shopping around for the most accommodating review board. A case in point is that of Dr. Akio Wakabayashi and the laser surgery he developed. He was at the University of California at Irvine in 1989 when he experimented with a new treatment for clearing the airways of emphysema victims. Seven of his first 56 patients developed fatal complications. Some of his colleagues suspect that the Irvine review board found the numbers worrisome; Wakabayashi claims the university "couldn't buy the equipment I needed." Whatever the reason, he transferred to Chapman General Hospital, just 10 miles away, where he continued his experiments.

Soon after Wakabayashi joined Chapman, he started having run-ins with its review board. "His lack of getting published always was a concern," recalls Howard Levine, the hospital's chief executive officer. "We kept saying, 'You need to get your data peer-reviewed.' And every month we would have a discussion about this. He promised it would appear in the journals, but for as long as he was here, it never did."

Last year Wakabayashi moved yet again--this time to the Irvine Medical Center to establish the Wakabayashi Institute. Already he has a three-month waiting list for new patients. Although his surgery lacks a formal scientific evaluation, Wakabayashi believes he has proved his operation's merits. "It's hard to think of it as experimental when you've done 1,200 of them," he says. At any rate, he adds, he is finishing a report on his first 500 patients, which he says will be published soon.

Some hospitals have begun to expect more of their surgeons. Last year Columbia-Presbyterian Medical Center in New York City opened a new center for the evaluation of surgical innovation. "With life-threatening illnesses, the pressures are great to try new things," says Annetine Gelijns, the center's director. Her team tries to resist those pressures long enough to consider some tough issues--such as whether there are ways to evaluate new operations that would be faster than the slow but sure process of a scientifically controlled study. For desperately ill patients and the trailblazing doctors who believe they have found new treatments, the answers can't come soon enough.

--Reported by Sheila Gribben/Chicago and Jenifer Mattos/New York

With reporting by SHEILA GRIBBEN/CHICAGO AND JENIFER MATTOS/NEW YORK