By Sarah Fenske
By Danny Wicentowski
By Lindsay Toler
By Danny Wicentowski
By Danny Wicentowski
By Jessica Lussenhop
By Lindsay Toler
By Lindsay Toler
Jim was slowly suffocating and running out of time. Doctors warned him he'd be dead in a few years, but Jim didn't feel like he had much of a life anyway.
"I was like the living dead," he says.
This was the price of a lifetime of smoking, doctors told him in 1988, when, at the age of 52, he was given a diagnosis of emphysema. At the time, the Overland Park, Kan., resident was making his living selling financial services, not a profession that brings to mind lots of physical exertion. Yet within a year, Jim had to quit working and go on disability. He just couldn't get enough breath for the job.
Emphysema is a progressive disease: It just gets steadily worse and worse, slowly strangling its victims and sapping their ability to fight off other diseases. The weaker Jim became, the more fatalistic his outlook. He even kept up his steady cigarette habit, believing it was too late to undo the damage to his lungs.
But his attitude began to change in November 1995. Jim was in the hospital with pneumonia when his pulmonologist told him he might qualify "for that new surgery." Just weeks earlier, the Health Care Financing Administration (HCFA), the federal agency that administers the massive Medicare program, had begun paying in some states for a new type of surgery called "lung-volume reduction," a procedure that appeared to give breath back to some emphysema sufferers. For Jim, there was one catch -- to qualify for the surgery, a patient had to have been off cigarettes for at least six months. Given reason to hope, Jim says he "got serious" and quit smoking.
Then Medicare did an about-face. In January 1996, just weeks after agreeing to pay for lung-volume-reduction surgeries, Medicare abruptly stopped, saying the procedure was unproven and more research was needed. Many private insurance plans, which had covered the cost of the surgery, followed Medicare's lead and also stopped paying.
In just three months, Medicare had paid more than $35 million for 722 lung-volume-reduction claims -- and the cost was likely to keep growing. Doctors at the respected Mayo Clinic in Rochester, Minn., estimated that if just one-tenth of the nation's 2 million emphysema sufferers got the surgery, the cost would exceed $4.6 billion. Despite a prevailing view in the medical community that lung-volume reduction works, Medicare decided it needed a study, so it launched the National Emphysema Treatment Trial (NETT). But the study appears to have raised more questions about Medicare's motivations than answers about emphysema. NETT has sharply divided leading medical researchers and surgeons over questions of medical ethics, research methods and health-care priorities.
When Medicare stopped funding, there was no controversy, no recrimination, no angry public debate. Jim and his wife, Linda, weren't alarmed. They figured Medicare just wanted to gather additional information and perhaps toughen up its criteria for eligibility. "We expected them to put it in the hands of the medical elite, to say that only hospitals that did lung transplants could do lung-volume reduction because those hospitals would have the staff trained to deal with lung patients," Linda recalls.
Hopeful that Medicare would soon restore funding for the procedure, Linda brought Jim to St. Louis, where he was evaluated by Dr. Joel Cooper, a surgeon at Barnes-Jewish Hospital who had pioneered successful lung-volume- reduction surgery.
But the couple's hope turned to fear as they waited all of 1996 on Medicare and Jim's condition kept deteriorating. And fear turned to desperation as 1997 passed with no decision from Medicare. For Jim, just getting out of bed was a struggle, moving to the couch an exhausting ordeal. "It just took all my energy to breathe -- it was like smothering all the time," he recalls. By Christmas, the couple decided, they couldn't wait any longer.
Linda called Barnes-Jewish, where Jim had been evaluated, to negotiate a deal. The St. Louis hospital agreed to a fixed charge that was about half their normal fee for the surgery. "If they hadn't agreed to a fixed charge," Linda says, "there was no way we could have afforded it, because if there had been any complications, the cost would have bankrupted us." Assured of a maximum price, whatever complications might develop, the Farrises scheduled the surgery.
The couple cashed in Jim's Individual Retirement Account and paid the hospital $28,500. Linda told them "to bill Medicare anyway -- I want to appeal when we get denied."
On May 19, 1998, Cooper cut into Jim's chest, spread open his rib cage and, using a surgical stapler, snipped pieces from each of his lungs. The stapler resembles a pair of scissors with a piece of staple-embedded tape on each blade. As Cooper cut off pieces of diseased lung, the tape and staples closed the cuts like the seal on a Ziploc bag. The operation took about an hour, with most of the time spent carefully sewing the rib cage and chest muscles back in place.
Jim was given painkillers immediately after surgery, and he was up and walking the next day. Five days later, he was on his way home. Before the operation, the volume of air Jim could exhale was only 19 percent of what is considered normal for a man of his age. Six months after the operation, he could exhale 63 percent of normal.
That improvement was the direct result of a surgical procedure Medicare did not and still will not approve. Fortunately for Jim, he had savings.
When Medicare denied approval for lung-volume-reduction surgery for Jim, the couple was forced to use their savings. "It was either hang it up or cash in the IRA," says Jim. "If I hadn't done it, I wouldn't be alive today."
The idea that cutting out a part of the lung could actually help emphysema victims breathe easier has been around since at least the 1950s. But no one had demonstrated a consistently successful technique until Joel Cooper and his Barnes-Jewish team did it in the mid-1990s.
When it comes to lungs, the 61-year-old chief of cardiothoracic surgery has been on the cutting edge for decades. At Toronto General Hospital in the 1980s, Cooper pioneered lung-transplant surgery. And in St. Louis, Cooper developed the successful stapler technique for lung-volume-reduction surgery.
If you need an idea of Cooper's credentials, just ask his peers. In 1996, the American College of Surgeons gave him the prestigious Jacobson Innovation Award, recognizing a career of achievement that included his work with emphysema patients. Lung-volume reduction would never have been generally accepted, the surgeons declared, "if Dr. Cooper had not developed and perfected the procedure and conducted the necessary clinical research." Just this April, the International Heart and Lung Society named Cooper one of the three greatest pioneers of heart and lung transplants in the world.
Cooper describes the procedure he developed for lung-volume reduction -- the same procedure he used on Jim Farris -- as a treatment of last resort for emphysema patients who no longer are helped by just physical therapy and medication. He first presented the results of his work on 20 patients at a meeting of the American Association for Thoracic Surgery in April 1994. The following January, the Journal of Thoracic and Cardiovascular Surgery published his results showing an average 82 percent improvement in lung function after lung-volume-reduction surgery in the 20 carefully selected emphysema patients.
"The results were so significant, they got everybody's attention," says Dr. Richard Fischel, director of the Chapman Lung Center in Orange, Calif.
Surgeons saw new evidence the procedure worked, emphysema patients saw new hope that their breathing could be improved and health-care providers saw something new they could sell. So when Medicare indicated in the mid- '90s that it was prepared to begin paying for the procedure, hospitals envisioned a huge and hugely profitable new market and rushed to offer the operation at their own facilities. Surgical-supply companies, anxious to encourage hospitals to launch lung-volume-reduction centers, ran "how-to" seminars and distributed booklets on how to successfully bill Medicare or private insurance companies for the procedure. Desperate emphysema patients, even those who would not benefit, clamored for the surgery.
It was a recipe for abuse.
Even though it took years to perfect the procedure, the technique for lung-volume reduction was almost absurdly simple -- so simple, according to some surgeons, that anybody with a surgical stapler could do it. But deciding which patients would benefit from the procedure and successfully caring for those patients after surgery required, as Cooper says, "a great deal of experience and expertise."
That's where many hospitals fell short. "There was a great deal of misleading promotion and advertising," Cooper says. Hospital administrators thought lung reduction "would be the angioplasty of the '90s," he says, referring to a profitable hospital procedure for unblocking clogged arteries that became common in the 1980s. Anxious for the revenue, they pushed doctors to do the operation even though the hospitals were not ready to care for the patients.
"Places that do normal surgeries tried to offer it. But these (emphysema) patients are respiratory cripples, and those places didn't know how to care for them," agrees Fischel. And it wasn't just because of hospital administrators. Cooper "is just being nice to his fellow surgeons," says Fischel. "There absolutely were greedy surgeons trying to make a buck. There were places doing it with 50- 100 percent mortality."
Indeed, it was an unexpectedly high number of deaths among the 722 claims Medicare paid -- a rate that exceeded what had been reported in medical journals -- that made the agency abruptly reverse course and stop funding the surgical procedure.
A Medicare spokesman referred The Riverfront Times to Dr. Steven Piantadosi, a clinical trialist at Johns Hopkins University in Baltimore and clinical coordinator for NETT. "Medicare said, 'Stop. We're spending a lot of money and we want to know if it really works,'" Piantadosi explains. "When you think about it, that is exactly what you want to happen," Piantadosi continues. "You don't want some cowboy surgeon saying, 'I did a few dozen of these, and the people seem to be OK, so let's make a national policy that any cowboy surgeon can do them.'"
Cooper was asked to serve on the initial advisory committee charged with designing a study that would prove, once and for all, whether lung-volume reduction actually helped people. If the surgery did help emphysema patients, the study would also determine how broad a group of patients it helped, make the risks and benefits of the procedure clearer and estimate the total cost of lung-volume-reduction surgeries to Medicare and private insurance plans.
On the advisory committee, Cooper argued that, in fairness to patients, Medicare should pay for the operation for those patients that everyone agreed were likely to benefit from the operation whether they chose to participate in the study or not, as long as it was done at an approved medical center, so that their participation really was given freely and not the result of financial coercion. HCFA refused.
Then Cooper said the study should at least have 'compassionate crossover,' which is a feature of drug trials. By the time a drug or device undergoes a large clinical trial, small trials have indicated that it is effective. The idea of compassionate crossover is this: When a large trial starts, if someone in a control group who was randomly denied the new treatment starts to deteriorate rapidly, doctors can show compassion to that person by offering the option of getting the treatment, of "crossing over" from the control group to the test group. Cooper wanted patients in NETT to have the same opportunity if their health went south. He didn't get it. Other trials, such as the Canadian and Italian lung-volume-reduction studies, have it, but Medicare patients in the U.S. would be denied that option.
Cooper, who had applauded Medicare for taking a step back in January 1996, saying its decision to halt funding "probably saved lives," now found himself on the outside as the parameters of the emphysema study became clear. He quit the advisory committee, and he didn't go quietly, either. The surgeon -- one of the world's top lung docs -- says the study is flawed and that HCFA is primarily motivated by a desire to save money. He has even criticized fellow surgeons who are participating in NETT, accusing them of acting unethically by agreeing to deny treatment to patients who may benefit from lung-volume reduction.
"There is nothing else these patients can be offered, yet we are to deny half of them this treatment, without any provision for patients who deteriorate or might be ideal candidates for it.... That's why I left the trial," Cooper says.
His earnest defense of lung-volume reduction is to be expected, given that he pioneered the procedure. He insists, however, that he has no objection to a randomized controlled trial "as long as it is not coercive, as long as the patient can choose to enter or not enter. When Medicare patients are told this is the only way to get the surgery, that is coercive."
He says Medicare's emphysema trial confuses two distinct things: how an insurer decides what to pay for and how scientists validate a procedure. "Lung transplants were covered early on by insurance, when there was still a lot of important data to be collected, as there is with any new procedure," he says. "You don't wait until you've written the last chapter to decide coverage."
But a more fundamental issue has divided surgeons. Cooper complains that the study forces participating surgeons and hospitals to lie to patients and, if they fall into the control group, to deny them the procedure that can significantly improve their health.
Given the high mortality rate for very sick emphysema patients -- 40-50 percent die within three years -- many of the study participants who are refused surgery will be dead before the trial ends, Cooper notes.
Other surgeons and their institutions refused to participate in the study for the same reason, including Fischel at Chapman Medical and Dr. Thomas Egan, director of the lung transplant program at the University of North Carolina at Chapel Hill.
"I was at (trial) meetings where every doctor criticized the randomization of half the people to medical care and the exclusion of compassionate care," says Fischel, but the study organizers refused to budge. He followed Cooper off the advisory committee. Egan explains why he refused to participate in NETT: "We felt it unethical to randomize patients who are good candidates for surgery, given that there is no other effective remedy for emphysema."
Indeed, so many surgeons have objected to the study parameters that last month, the American Association for Thoracic Surgery sponsored a debate at its annual meeting on whether Medicare's study is necessary and broadcast the debate over the Internet for surgeons around the world to see.
Despite the controversy, 17 hospitals, including St. Louis University Hospital, are participating in the study. Initially, those hospitals planned on enrolling 4,500 patients in the trial and tracking them into 2003. But the prospect of signing up for the trial and still not getting treatment was too disappointing for many would-be volunteers, so the study coordinators lowered their patient goal to 2,500. Enrollment still lagged, so Medicare resorted to hiring a PR firm to promote the trial. The total number of patients now taking part is 800.
The unwillingness of patients to volunteer is an indication of the study's flaws, Cooper says.
There is another problem with NETT, though. Cooper says he has been shocked to see emphysema patients who could not possibly benefit from lung-volume reduction randomly picked for the operation. Denying patients necessary medical care is unethical, says Cooper, as is operating on patients who can't be helped by the operation, only hurt. Therefore, he says, those surgeons who are participating in the study are acting unethically.
"I don't know how they can look at themselves in the mirror."
The top St. Louis investigator in the Medicare study doesn't have a problem with mirrors or sleeping at night. But Dr. Keith Naunheim, the 47-year-old chief of cardiothoracic surgery at the SLU Health Sciences Center, insists critics are flat-out wrong about the study: "I don't think it's unethical."
With his TV-star good looks and gentle demeanor, Naunheim is an ideal spokes-man for surgeons participating in the emphysema trial. It probably doesn't hurt that he was trained by the Fleishman-Hillard public-relations firm on handling press interviews. His voice radiates compassion and humor, and he even chuckles a little when asked about Cooper. "One thing about Joel is that when he gets on a roll, he is convinced that he is 100 percent right. A couple of months later, when he has had a chance to think it over, he might change his mind, but he is still convinced that he is 100 percent right."
Naunheim says that in his objections, Cooper presumes that the patients in the study who will be denied treatment would all benefit from the surgical procedure. And that's not a sure thing. No one can say for certain that the operation will help any particular patient, Naunheim says, because "five out of 100 patients die from the operation, mine and Joel's."
The point of the study, Naunheim adds, is to better identify candidates for lung-volume reduction and balance other important issues, such as a patient's quality of life after surgery. And one can't identify who is a good candidate without having cases where the surgery doesn't work.
"We don't know, on balance, what the cost will be to the population on whom we are operating ... what the cost is in morbidity and human suffering in order to get 10 patients who do very well. How many died? How many are on a ventilator?"
The financial question is important, too, Naunheim adds. "Every doctor, from an ethical standpoint, has to look at his patient and say, 'I will do the best for you.' If making an emphysema patient better costs $100 million, perhaps my job as a doctor is to say, 'Damn the money -- I will do it.' But can the country afford that kind of outlay of cash? Obviously not. There has to be time to look at the global perspective," which, he says, is what Medicare is doing.
Naunheim does admit, however, that the emphysema study is much more controversial than the operation it is designed to evaluate. "I don't believe there is a great deal of dispute that lung-volume-reduction surgery is beneficial in certain patients," he says. "The real questions are, who will benefit, for how long, and is the benefit worth it?"
That general agreement that the surgery does help some patients is exactly Cooper's point, however. Ethically, he says, those patients should be given a choice: If they want to participate in the study, fine. If they don't want to be in the study but want the surgery, that should be fine, too. And, Cooper says, it's unethical for doctors to withhold that choice from patients.
That view is bolstered by medical ethicists who aren't involved in the study. "The desire for clear knowledge is trumping the desire to help patients," says Dr. Griffin Trotter, a professor at the Center for Health Care Ethics at SLU and a practicing physician. "If there is no clear reason someone will be helped by the surgery, it is unethical to put them in. The public should be concerned about this. The study may be well designed from a purely didactic point of view, but it's poorly designed from an ethical point of view."
Cooper forcefully argued the ethical issue during the discussions to launch the study. To help settle the matter, says Piantadosi, the study's clinical coordinator, a panel of ethicists was appointed, and they ruled that surgeons who believed in the surgery could ethically participate in the trial if they had "equipoise," meaning that they believed the surgical community was split over whether the surgery was valid and they respected those differences of opinion -- sort of an "embracing diversity" program for scientists. But even Piantadosi admits surgeons were near unanimity on whether lung-volume reduction helped some emphysema patients. And, if that was the case, there was no real equipoise -- that is, no real division within the surgical community about the value of the procedure.
Both Cooper and Naunheim say lung-volume-reduction surgery helps some people. They both say more study is needed to determine how long the benefits of the surgery last and how broad a group of people it can help. So, what's the difference? Why does one participate in the study and the other criticize it?
Beneath Cooper's concern about coercive pressure on Medicare patients lies a distrust of Medicare's motives.
To justify its study, Medicare had to cast doubt on previous studies of lung-volume-reduction surgeries. Its researchers did that by mixing results from Cooper's staple procedure with results from other discredited lung-volume-reduction procedures and by mixing results from hospitals equipped to care for very sick lung patients with results from those that were not, instead of separating cases on the basis of various criteria to see what worked best. Even Naunheim concedes Medicare "mixed apples and oranges," but he adds that this should not invalidate the current study, which will yield a lot of new information about emphysema in addition to whatever is learned about lung-volume reduction.
"I think we are going to learn a lot from the study," agrees Egan, a critic, "but I'm not sure we couldn't have learned just as much from studying patients who were operated on vs. those who weren't without limiting access to the procedure."
The government official overseeing NETT, Dr. Gail Weinmann, project officer at the National Heart, Lung, and Blood Institute, now admits that mixing together the results of different procedures, including one in which physicians burned the exteriors of lungs with a laser, was not a fair way to assess the effectiveness of Cooper's lung-volume-reduction surgery. "There were an awful lot of patients who underwent the laser surgery," she says, but most doctors have abandoned this procedure, and it's not included in the emphysema trial.
If the people running NETT concede that data were manipulated to justify the study, Cooper wonders, can they be trusted to honestly analyze the study results? The incentive to declare the treatment a failure grows with each month that Medicare refuses to pay for it. By the time the study is scheduled to end, hundreds of thousands of emphysema sufferers eligible for lung-volume-reduction surgery since the payment ban took effect will have died. "How can they justify those deaths without a conclusion that (the surgery) doesn't work?" he asks.
Such distrust cuts two ways.
Piantadosi dismisses most previous surgical research on the operation as biased. "You can't rely on surgical practitioners to recognize potential pitfalls (in their research procedures)," he says. "Surgery has no culture of evidence-based research.... Surgeons traditionally have shown respect for elders and experience and a hostility to the scientific method."
Piantadosi says bad outcomes demonstrate that surgeons didn't know who could be helped by the operation. "All this stuff about surgeons' thinking they knew who would benefit was not true. They did not have good judgment." And he calls the supposed difficulty in defining selection criteria and in training a surgeon to properly select patients for the procedure "surgical bullshit."
Naunheim presents himself as the bridge-builder between the two sides. Both sides are right from their own points of view, he says. "It is like a glass being half-full or half-empty." He is participating in the study, then, to show the government that lung-volume-reduction surgery benefits not some individual patients but the population as a whole so that Medicare will restore funding for the operation, "hopefully in another one to two years."
Cooper says it's inexcusable to have patients wait even that long, or die, particularly because there is no disagreement that the operation helps some patients. He says Medicare should restore funding for the procedure, at least at hospitals with the capability and track record of handling lung transplants, such as Barnes-Jewish. And Medicare should redefine the parameters of its emphysema trials to permit compassionate crossover -- allowing surgeons to operate on rapidly deteriorating study participants. Both steps, he says, could be taken immediately.
Meanwhile, emphysema patients still wait to exhale. How many could benefit from lung-volume-reduction surgery? Nobody knows for sure. Cooper puts the number at about 200,000; Naunheim says the operation has the potential to help twice that number.
The fact that many people would benefit is no longer in question -- except, it seems, to Medicare.
Two years after his operation, Jim Farris is off oxygen and works two days a week as a maintenance man at a church. He washes windows, sweeps and vacuums, keeps the air conditioning running and even hefts 50-pound bags of cement. He walks three miles three times a week and exercises his arm and chest muscles on Nautilus machines. And he's driving.
"I still have emphysema, which is a progressive disease, but with surgery, exercise and not smoking, I don't know how long I can last. No one else knows, either. I might now live out a normal life span, but if I die tonight, I've had two great years. Would I do it again? In a minute."
Though his air capacity has fallen slightly -- down to 55 percent of normal compared with 63 percent six months after the surgery -- "that is still nearly three times what it was," he says.
Jim's improved quality of life isn't the only good news.
On Feb. 23, an administrative-law judge in Kansas City heard evidence on the Farrises' Medicare appeal. Twelve days later, Judge Gary Lowe ruled entirely in the Farrises' favor. In his opinion, Lowe wrote: "The record clearly demonstrates by substantial evidence that this procedure is not experimental, is well recognized in the medical community and was clearly successful in this particular case." He concluded that the procedure was both reasonable and necessary under the law and ordered Medicare to pay the bill.
Lowe's decision -- though clear and direct -- doesn't mean Medicare will change its policy. But it does mean, at least for the Farrises, that their fight is over. On March 28, Medicare told Barnes-Jewish that it would not appeal the decision. Medicare said it would pay for Jim's surgery, and the Farrises were due a refund. They received payment last week.
Nearly two years have passed since the surgery. The Farrises know that if they hadn't had any money, Jim would probably be dead today. With Medicare and most private insurers still refusing to pay for lung-volume reduction, the Farrises are left to wonder.
"If you have money, there is hope," says Linda. "If you have it, you can get surgery and a new lease on life. But what happens to poor people? What happens to people who don't have this money?"
For more information, see Removing A Doorstop.