2 Doctors Quit Emphysema Study

Frustration over guidelines limiting access to surgery for some emphysema sufferers has led two surgeons, including one affiliated with Chapman Medical Center in Orange, to drop out of a controversial national medical study.

While the defections do not threaten the study, they raise intriguing questions about the nature of medical trials and the ethical equations that lie behind deciding who may receive what treatments.

“There are many reasons to stay in this study--it is going to determine how emphysema will be treated in the future,” said Dr. Richard Fischel of Chapman Medical Center, who nonetheless withdrew from the program two months ago.

“The problem is it denies access for a lot of people who could get a lot of improvement,” he said. “I could not see myself staying in the study and being told that I had to look a patient in the eye and tell him that I can’t do anything [to help his condition] when I know I can.”

At issue is a six-year medical trial that the federal government agreed to conduct two years ago after Medicare officials stopped paying for a procedure called lung volume reduction surgery. Since Medicare covered about 80% of the cases, and private insurers often follow Medicare’s lead in deciding what procedures to pay for, the decision led to a de facto moratorium for all but those who can afford the $30,000 procedure on their own.

Yet even critics said the moratorium was based on valid factors, including high mortality rates at medical centers inexperienced in the procedure, and lack of studies on the procedure’s long-term effects.

The medical trial covers about 2,600 patients at 17 medical centers, including Cedars-Sinai in Los Angeles. Researchers hope it will help determine whether lung volume reduction surgery is an effective method for treating patients debilitated by emphysema.

But the guidelines for the study bother some surgeons. The study requires doctors to mix prime candidates with riskier candidates in a pool from which patients are assigned randomly to receive the surgery or physical therapy. Another requirement bars surgeons from treating emphysema patients outside the study.

That means participating surgeons may be barred from operating on patients they know they can help.

Backers of the study say the design--developed with input from the surgeons--is necessary for objective analysis. And barring surgeons from accepting nonstudy patients ensures against doctors funneling poor patients into the study--and the random pool--while performing surgeries privately for those who can afford it.

“That protocol has been designed by all the surgeons participating in it,” said Dr. Claude Lenfant, director of the National Heart, Lung and Blood Institute of the National Institutes of Health.

Fischel argued that surgeons experienced in the procedure should be allowed to perform surgery on patients they know would benefit from it, while focusing the study on patients who don’t meet all the criteria.

“They wanted to set up a study giving them complete and total control,” Fischel said. “But they’re limiting public access to some of the best doctors for treatment of emphysema. Your option is to drop out of the study, and that’s the option I chose.”

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The underlying issues point up an ethical conundrum for doctors who are also researchers--to whom do they owe their loyalty, the patient or science?

“They really have different roles,” said Leonard Glantz, a lawyer and ethics specialist at Boston University’s School of Public Health. “Physicians are supposed to owe all their loyalty to their patients. Researchers have a more mixed loyalty to science, as well as to their patients.”

The issue centers on a surgical procedure for “end-stage” emphysema sufferers, those who labor to breathe even at rest, have severely limited mobility and rely on oxygen tanks to ease breathing.

Emphysema, an irreversible disease that most often afflicts current and former smokers, is the breakdown of the walls between the alveoli--tiny air sacks in the lungs--which swells the lungs while reducing their elasticity. In end-stage cases, the lungs press against the diaphragm, forcing the patient to use stomach muscles to breathe--an inefficient and exhausting process.

One doctor described the effect as similar to a healthy person taking a large breath and then, without exhaling, taking another breath.

In lung volume reduction surgery, diseased portions of the lungs are removed, opening up space inside the chest cavity for the healthy remnants of the lungs to expand--and making it easier for the patient to breathe.

The technique was first used in 1960 but soon was abandoned because of the high number of patients who died. The technique was revived a decade ago when surgeons began using lasers that shrink damaged tissue to reduce the lung mass and increase flexibility.

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While the laser technique still has its defenders, studies have shown that surgically removing the tissue is more effective. In that procedure, developed by Dr. Joel Cooper of Washington University School of Medicine in St. Louis, cow heart tissue and staples are used to seal where the diseased tissue has been cut away.

Cooper, who initially was among the surgeons urging Medicare to pay for the procedures, also dropped out of the study. He could not be reached for comment.

Fischel traces the problem with the procedure to Cooper’s presentation of his success at a medical convention about four years ago.

“People all around the country said, ‘Hallelujah, they found a cure,’ and started doing this,” Fischel said. “A lot of people didn’t do it well, and a lot of bad results were achieved.”

Fischel and his partner in private practice, Dr. Robert McKenna, have performed nearly 500 surgeries, with a mortality rate of about 4% while improving the quality of life for about 85% of their patients, they said. Key, though, is finding the right patients.

Fischel estimated that of about 1 million emphysema sufferers requiring medical care nationwide, only 15,000 or fewer would meet the criteria for the surgery, ranging from general physical condition to the way the disease has affected the lungs.

“We’ve done 500 surgeries, and we saw 3,000 patients to select those 500,” Fischel said.

McKenna is staying with the study through Cedars-Sinai despite his own reservations.

“The patient selection criteria can be further refined,” he said, but added that some of the unanswered questions about how long improvements last are best answered through a randomized study.

He said he fears the results might be skewed if surgeons experienced in the procedure drop out of the study.

“One of the issues [in Medicare stopping coverage] was patient safety,” McKenna said. “Many hospitals that tried to offer this to patients had a high mortality rate during the learning curve of getting the program started up. It’s important that [doctors] with experience participate so that the study does not suffer.”

It was not an easy decision for McKenna and Fischel. Part of the fallout is that the surgical partners can no longer assist each other with their patients.

“Everything in life, every issue, has a pro and a con to it,” McKenna said. “You just have to balance out and decide which way to go.”