-------------New Controversy About Lung Surgery for Emphysema Patients
　　By Maria A. Flores

B O S T O N, July 26 ?A pioneer in a surgical procedure that improves the quality of life of patients with emphysema says an ongoing government study testing the method should end because it is costing taxpayers millions of dollars and tens of thousands of patients?lives.
　　Dr. Joel Cooper, chief of cardiothoracic surgery at Washington University School of Medicine, in St. Louis, is calling for the ban because a new British study shows that surgery he forged ?the removal of damaged parts of emphysema patients?lungs ?improves patients?ability to breathe, their quality of their life and their ability to walk longer distances.
　　Cooper says the research published in the current issue of the New England Journal of Medicine, one of more than 30 reports of more than 2,000 operations, provides further unequivocal evidence of the benefits of lung reduction therapy and the need to stop the U.S.-based randomized trial of 2,500 patients determining the value of the surgery.
　　But those running the study, called the National Emphysema Treatment Trial, say the 7-year, multimillion trial is necessary since many questions remain about the $30,000-surgery, including who will benefit from it and whether it will reduce mortality rates.
　　Surgery Improves Quality of Life
　　In the British study, surgeons at the Royal Bromptom Hospital, in London, randomly assigned 48 patients to either have the lung reduction surgery or continued medical and drug treatment to compare the two methods. Doctors were not aware of the group to which the patient was assigned.
　　The British physicians, led by Dr. Duncan Geddes, a professor in the department of respiratory therapy, found that the surgery provided the patients with enhanced breathing, longer distances walked, and a better quality of life compared to the non-surgical patients. It was not clear if the surgery helps the emphysema patients live longer.
　　 Emphysema is a form of chronic pulmonary disease that affects approximately 2 million Americans at an annual cost of $2.5 billion. In patients with this condition, the walls between the tiny air sacs in the lungs, called alveoli, become damaged and the lungs are less able to expand and contract, making breathing difficult.

Medicines Often Fail
　　The disease is chronic and progressive, leading to disability and early death. Around 82 percent to 90 percent of emphysema cases are due to chronic smoking. The non-surgical treatment involves oxygen treatments, smoking cessation and medicines to open the lung’s airwaves called bronchodilators. Many patients become unresponsive to the medications.
　　Experts estimate that 200,000 to 400,000 Americans with emphysema might benefit from the surgery. It was 1994 when Cooper first reported the outcome of a lung reduction trial of 20 patients at the American Association of Thoracic Surgery meeting.
　　The surgery caught on and Medicare paid for the procedure, explains Cooper, but the agency stopped reimbursing it because the hospitals were not choosing the right candidates for the procedure and were not providing appropriate follow-up care and too many people were dying.

Unethical Federal Trial?
　　As a result, in 1996, the National Heart Lung and Blood Institute in collaboration with the Health Care Financing Administration, the agency that runs Medicare, developed the National Emphysema Treatment Trial. Scheduled to run until 2002, 19 facilities are currently participating and 800 patients have been involved. The government pays for the subjects?participation.
　　Cooper’s institution originally participated in the trial but quit because he believes patients assigned to the control group should not be denied surgical treatment if they show signs of deterioration as the trial progresses.
　　“If a patient in the control group was doing poorly, doctors should be compassionate and allow the patient to crossover to the test group,?Cooper says. Cooper compared the trial to the infamous Tuskegee Syphilis study, in which black men were denied treatment for the disease in order to study the course of the disease.
　　Cooper claims the trial is having trouble recruiting patients because of the randomization. As a result, patients are missing out on the surgery since they cannot afford it and because Medicare will not pay for patients outside of the trial even though some private insurers, such as Blue Cross/Blue Shield and Aetna, do.

Federal Scientists Defend Study
　　But Dr. Gail Weinmann, a spokeswoman for federal trial, defends it, saying: ?Based on the information available, the review board continues to believe that data needs to be gathered in order to make an informed decision about whether or not they want to do lung volume reduction surgery.?br /> 　　Dr. Weinmann also said that a randomized trial is essential for determining which treatment is better. If the data were convincing, she said, they could modify the protocols.
　　But others believe the evidence is clear. Dr. Cameron Wright, a thoracic surgeon who is leading a trial at Massachusetts General Hospital, in Boston, which allows patients in the control group to get the surgery if they degenerate, believes that some of the end goals of national trial are wrong.
　　“They are looking at mortality rates,?Wright says. “They want to know how many people will die without this. That’s a ridiculous question. For most of us doctors, the important thing is quality of life. Here is a procedure that is proven to be effective…it improves the quality of life. We know these patients fare better.?/p>

(From ABCNEWS)