Life, but at What Cost?
an emotional odyssey where good intentions, hopes and
By Stacey Burling INQUIRER STAFF WRITER
Sep 29, 2002 --
Last December, James "Butch" Quinn walked into a Philadelphia news conference, a thankful, smiling testament to the wonders of technology.
Just 32 days after his diseased heart had been replaced by a machine, he talked of the beauty he saw in the simplest things, of his deep gratitude to his doctors and to God, of new and blessed hope.
He talked about something else, too, something that would become an obsession as he and his doctors struggled to make man and machine work together. He said: "I want to go home."
Nine months later, Butch Quinn's body, minus the plastic and titanium heart, lay in a flag-draped casket in a packed North Philadelphia church. A woman sang a gospel song picked by Quinn's widow, Irene:
"I ask a question, Lord,
Why so much pain?
But he knows what's best for me,
Although my weary eyes, they can't see,
So I'll just say, thank you Lord,
I won't complain."
Irene, a tiny woman dressed in black and for once looking all of her 55 years, cried quietly. She had cried almost every day for 10 months, regretting their choice to exchange a certain, simple death for the unknown life of a medical pioneer. But now she felt at peace. Her husband would suffer no more.
She was surrounded by people who remembered Quinn as a warm, outgoing man who reveled in his grandchildren. They barely mentioned the device that had made him front-page news.
But others at the funeral would never have known Butch if not for his experimental heart. Drawn by the man and his wife into an emotional odyssey, they found themselves grappling with profound questions: Can desperate, dying people make sound decisions? What makes a life worth living?
Sheldon Zink, 40, a medical anthropologist and ethicist from the University of Pennsylvania who became the couple's advocate at Hahnemann University Hospital, sat just two pews back. She had been so busy helping Irene that this was her first chance to grieve. She said of her months immersed in the Quinns' lives: "I had moments of euphoria, and I had moments when I felt like I was really traumatized."
In a rear pew was Elena Holmes, 34, a nurse practitioner who had cared unceasingly for Quinn. During the first month, she left the hospital only twice. It was her job, on his final day, to turn off the heart.
Beside her, dark circles under his eyes, his skin ashen, was Louis Samuels, 39, the heart surgeon who fulfilled a boyhood dream when he put the AbioCor artificial heart in Quinn's chest. Like Quinn, he was religious and emotionally open. He had never grown so close to a patient. "You can parallel me with him," Samuels would say. "When he was at his best, I was at my best. I felt everything he felt: the anguish, the disappointment, the desperation, the pain." Now, he was trying to remember the good times that, in his mind, outweighed the bad.
A few feet away sat a man who had met Butch Quinn just twice, but who had been an important, if nearly invisible, presence for months: Alan Milstein, Irene Quinn's lawyer. Milstein is carving out a new legal specialty - suing people and institutions who perform clinical trials. He questions whether the dying can make truly "informed" decisions. He believes they should be told in the baldest terms they will be part of an "experiment" and should proceed only if they want to be a "martyr for science."
'Going into an unknown'
As Samuels, the Drexel University surgeon, would tell it, this was a story with many layers. It was news because of the untried machine. But even the doctor, a man who lobbied for years to be among the first to try the device, knew early on what made this experience special. It was the very humanity of it, the mix of good people and good intentions, faith and hope and sacrifice and fear, disappointment and that most primal of animal desires - sheer will to live. Ultimately, it was about the collision of dreams with reality.
"It was an amazing story from the very beginning to the very end," Samuels said.
Near death from heart failure, Butch Quinn last November became part of the decades-old quest for an artificial heart that would allow people to resume normal lives.
Abiomed Inc., a Danvers, Mass., company, had created a fully implantable device, that, before that summer, had been tested only in cows and pigs. Usually, the first people to get something this new are on the verge of death and out of other options.
Of the seven patients who received the artificial heart, only one is alive. Tom Christerson, of Kentucky, who got the heart more than a year ago, went home in April. Three others survived two to five months. The remainder died in surgery or soon afterward..
In trials of new medical devices, it is typical to learn from the first patients who is likely to do well and who should not be a candidate, said heart surgeon Bud Frazier of the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston. Frazier, who is involved in this trial and has worked on development of the heart for years, will no longer give the device to patients who, like Quinn, have cardiac cachexia, an advanced stage of disease characterized by emaciation and wasting.
It is also typical, he said, that many of the first patients die, that no one can predict how patients will do. "When you're going into an unknown," he said, "it's just that."
Zink, an expert on the effect of medical devices, has heard the arguments about the inevitability of deaths as new treatments are being perfected.
Researchers tend to see scientific growth and forget the human price, she said.
"I think that it's certainly healthy to pause every once in a while and, if you can, look at one man's life, like Butch's, and say, 'Is this actually worth it for the person that's doing it?'"
Committed to life, love
Butch Quinn entered the hospital an ordinary, if exceptionally likable, man. He was a 51-year-old former baker and Vietnam veteran disabled by post-traumatic stress disorder. He had been a cocaine addict and, 10 years earlier, had been so dispirited that he had prayed for his own death.
He emerged from his trials with a strong faith, an appreciation for the simple pleasure of sitting in a plastic chair on his porch in West Philadelphia or teaching his toddler grandson to sing "Bad to the Bone." He had an endearing willingness to talk about how much he loved Irene and their family. He once sat through Grease four times to please his daughter and her friends. He liked crabcakes and Emeril Lagasse, bingo and pool. He had a glorious laugh.
"I never heard him say a bad word about anybody," said Elena Holmes, the nurse practitioner. "He was easy to like and easy to take care of."
Samuels, the surgeon, found much to admire: "I liked his honesty. . . . I liked his courage. . . . I liked his idealism, his altruism, his sincerity. I liked his capacity to push himself. . . . This guy was a survivor. I very much liked his profound sense of faith and belief in God because, deep down, I feel the same way."
"I felt really lucky that they had chosen somebody so extraordinary," said Zink, who often talked with Quinn late into the night. She was newly married, and he often chastised her for spending so much time away from her husband, Tim. So she started bringing Tim to the hospital. She was impressed by Quinn's sociability and by his hunger for life.
"He really wanted to live more than any person I'd ever seen in my whole life."
By all accounts, Butch and Irene Quinn, married 23 years, had a strong relationship. "She's more than my better half," he would whisper from his hospital bed.
"They were just intensely dependent on each other," Zink said. "They had a long history. . ., the way people get really deeply entwined in each other's lives when they've had a lot of hardship and a lot of good times. It had been a long time since I had seen two people that were that committed to each other."
They 'danced in jubilation'
The Quinns wound up in Lou Samuels' office at Hahnemann in October after Butch's cardiologist told him there was nothing more she could do.
Samuels, who had been preparing for the artificial heart trial since 1995, was looking for his first patient. While Elena Holmes observed, Samuels explained the device and the trial to the Quinns. Holmes was impressed with the quality of their questions.
There was some concern about whether Quinn's chest would be large enough for the machine. He would have to be measured. There would be more visits to evaluate him medically and discuss the risks with an independent patient advocate, an unprecedented feature of this trial. The Quinns would sign an 11-page informed consent document. Four men had had the surgery so far. None had left the hospital.
When they learned Butch had been chosen for the trial, the Quinns danced in jubilation.
The surgery was set for mid-November, but early that month the Quinns came back to Samuels' office, fearing he wouldn't live until the scheduled date. "If you're going to do anything, let's do it now, because I can't wait," Butch Quinn said. Samuels agreed. He moved the date up to Nov. 5.
Quinn later described the 10-hour operation as a religious experience. "I felt like I met God," he said. He felt the many people praying for him and the doctors and nurses were working as one. "It was like one hand," he said. "This hand, every time I slipped into darkness and could feel nothing but darkness around me, this hand pulled me back into the light."
Immediately after the surgery, Quinn began having serious lung problems. At one point, it took eight people just to run the machines that were keeping him alive. It was touch and go for much of that first week. Samuels, a Conservative Jew, also felt a spiritual presence. "There have been times when he could have gone and he didn't and I don't have an explanation from all my knowledge of why he didn't go," he said.
Finally, Quinn awakened. They'd made it over the first hump. Samuels and Quinn had a long talk one evening about life and how glad they were to be alive, and Samuels was hit with the full impact of what he had done. He'd done many heart transplants, but this felt different, uncomfortable and unsettling.
"In some respects, it's creating life," he thought. "This is almost too powerful for somebody, some human being, to do."
When they finished talking, Samuels, filled with joy and wonder and gratitude, walked into a nearby room. He sat in the dark and sobbed.
Irene Quinn remembers the first time she saw her husband after the surgery. He was in intensive care, surrounded by wires and tubes and machines. He looked like a monster.
At that moment, she knew they'd made a mistake. "Oh, my God," she thought. "What the hell have I done?"
When Butch Quinn first walked into the public eye, he seemed a happy man. He had been improving so quickly that the staff was having trouble keeping up with him. He had eaten Thanksgiving dinner with his family. He was eager to visit his church, and Samuels had promised to go with him. For the first time in the trial, a hospital was thinking of sending a patient home.
Irene, a nurse's aide who is quieter and less comfortable in the limelight, said it was a miracle to see him so alive. She had come to view the medical staff as friends. "They make us feel so good, just being in their presence, feeling the vibes," she said, her voice cracking.
Butch Quinn said the choice to enter the trial was an easy one: "There actually wasn't much of a decision to make. To me, it was either do or die.
". . . I understood that I would be a pioneer. The most important thing that did come to mind to me was, if this thing works or if it didn't work, I would be giving something to mankind."
Irene Quinn says now that she and Butch were saying what they thought everyone wanted to hear.
'All I know is to move forward'
On the morning of New Year's Eve, Butch Quinn had a small stroke that left him with blurred vision and balance problems. But three weeks later, though obviously frail, he was well enough to become the first patient in the trial to be discharged from the hospital.
He and Irene moved to the Hawthorn Suites, a hotel near Hahnemann. Elena Holmes stayed in an adjoining room at night. A clinical specialist from Abiomed was with them during the day.
Quinn had visited his church the Sunday before Christmas. He had gone out to eat, seen Will Smith in Ali, played bingo, played with the grandchildren.
Samuels believed Quinn's quality of life was already better than it had been before the surgery. He felt "unbelievably proud" when Quinn was able to leave the hospital.
On the day late in January when the Quinns talked with reporters at their new home, Irene said she was "really, really happy."
What she did not say is that she was upset that they had not been given a nurse, round-the-clock. Samuels said that wasn't necessary.
Butch Quinn, suffering then from a slight cold, downplayed the stroke.
"All I know is to move forward," he said. "This is training I attribute to the military. You always advance. You never retreat. . . . I suffer things on a daily basis, but nothing I will let hold me back, keep me back from getting back to my home, to my life."
A wife disgusted and upset
Butch's stay at the Hawthorn lasted only three weeks. Then he was back in the hospital with pneumonia, especially dangerous for a man with emphysema and pulmonary hypertension. The infection began a downward spiral that would keep him on a ventilator for months, plagued by one medical problem after another. The biggest issue was that the blood thinners he took to prevent blood clots were causing bleeding in his lungs and gastrointestinal tract.
One day, Irene walked in and saw that his eyes were filled with blood, the whites turned red by broken blood vessels. "Have you ever seen a Dracula movie?" she asked, disgust still showing on her face.
It was wrenching to watch his pain. She felt his suffering to her core. And she felt helpless to make it better. "I can't do anything to help him. When he was home, if he got sick, I can hold him and hug him and rock him like a little baby, give him some medicine, my concoctions. Here I can't give him aspirin."
Irene was coping with a life totally changed. She had lost her job, because Butch feared being alone at the hospital at night. They had no privacy; the hospital had become her life.
Though hospital officials had promised her all the expenses would be taken care of, she began receiving bills at home. She also began to question whether the medical staff was telling her everything about Butch's condition. And she didn't trust her advocate to fight for her rights.
In March, crying uncontrollably, she suffered what she called a "nervous breakdown." She spent a few days in the hospital herself to rest.
When Irene Quinn got out, she told her husband about Milstein, a lawyer she had found on the Internet. He had made news by successfully suing the University of Pennsylvania's gene therapy program. She says Butch Quinn made the call.
Samuels remembers spring as a difficult period, as well. "I told [Irene] we got spoiled because he looked so good at one and two months," he said in March. "Now I think we're confronting the realities of his condition. . . . It's hard. It's incredibly hard."
In April, he was shocked to see her quoted in Time magazine saying her husband was often in such pain that "death would have been better."
He had not realized how upset she was. He and others at the hospital had asked if they could help, but she had stoically said she was fine. They thought she was getting the support she needed from her family and church.
But she was at the hospital so much that it cut her off from her friends. She was lonely and isolated, afraid to complain to the people who were responsible for her husband's care.
"I was fighting this thing all by myself," she said. "I didn't have a shoulder to cry on."
She felt she had to hide her tears from Butch. "I never let him know how I felt and what I was thinking and what I was feeling because I was his strength," she said. "If I'm weak, then I couldn't help him. I had to stay strong for him."
A birthday in the hospital
By June, the Quinns had fired their first advocate and chosen Zink, who had been observing the trial, as his replacement. There were more bills, mostly from Drexel University School of Medicine's physicians, who work at Hahnemann. Irene Quinn was furious and worried because she had lost her health insurance with her job.
(Officials from Hahnemann and Drexel say the Quinns should not have gotten any bills and are not responsible for paying anything.)
Butch Quinn's medical condition was improving gradually. He was desperate to go home. Because he was still so sick, that would require skilled nursing. And there would need to be changes to his house, such as air-conditioning and a wheelchair lift.
Zink tried to speed up the process, but found it surprisingly difficult. The three entities that had agreed to fund the trial - Abiomed, Hahnemann and Drexel - had not worked out who would pay for care if Quinn went home. They continued, she said, to argue about who should pay for various things the Quinns would need through the last week of Butch Quinn's life.
The money debates frustrated everyone. Butch Quinn told her, "The only thing I've ever asked them for is to go home, and I'm still in the hospital."
In July, Quinn, who had celebrated his 52d birthday June 30, was still in the hospital bed, improving at a snail's pace. He had come off the ventilator. Because of the bleeding problems, Samuels and Quinn had decided to stop the blood thinners and take their chances on a stroke.
"The situation we have now is a thousand percent better than it was even a month ago," Samuels said. Nothing was keeping Quinn from home, he said, except for the complications of arranging full-time nursing.
Around this time, Irene Quinn was getting letters from a collection agency about anesthesiology bills. Nine - totaling $13,544 - arrived on one day in August.
Butch Quinn, exhausted from months of illness and bored with being cooped up in the hospital for months, said he was still fighting to live, but he questioned his decision to enter the trial. "I don't believe I would do it again simply because it's too much afterwards, you know," he said in a raspy, barely audible voice from his hospital bed. "I've gone through more than any man can stand or bear."
Seeing Irene's pain was one reason he wished he hadn't tried the heart.
"I can see the breakdown in her eyes," he said. "I know she's unhappy. . . . I feel it all the way through me."
Irene says they never expected this. They had thought he might die quickly after the surgery, or recover and live another 10 or 20 years, not get stuck in this medical purgatory.
She thought Samuels had seemed confident the machine would work. When she asked him about sex, she says he told her, much to her husband's interest, "You'll have to take aerobics to keep up with him."
Samuels said he made the risks very clear.
Good times, then a stroke
Holmes made six trips home with Butch in August. Samuels came on several of them. On the couple's anniversary Aug. 11, Quinn spent the day with family and friends, reminiscing and laughing more than he had in months. The next day, the Quinns went out to dinner and a comedy club.
"Those times were great," Samuels said. "We were thinking, 'This is going to be good.'"
Veterans Affairs paid for modifications to his house. The hospital continued working on getting 24-hour nursing.
Butch Quinn's spirits improved markedly, and so did Irene's. Zink wondered whether he had changed his mind about the heart. "One of the last conversations I had with him, he said he wouldn't tell anyone to do it," she said. "If it was going to save his son's life, he would say no. That's a big testament from a guy who really wanted to live."
Zink, Samuels and Holmes were all confident that he would finally get his wish to go home. Samuels thought it could happen soon after Labor Day.
But Irene Quinn said her husband was skeptical that the trial sponsors would ever fund the nursing he needed. "They'd rather kill me than pay for round-the-clock nursing," she said he told her.
Before she left for a business trip Aug. 22, Holmes promised to take Quinn home every day the following week.
But, at 7 the next morning, a nurse called to tell Samuels that Quinn had had another stroke, a bad one. Samuels and Irene decided to try TPA, a clot-busting drug. Quinn got a little better. Later that night, though, a CT scan showed a small bleed in his brain. Soon, his condition was plummeting.
Samuels knew it was over. He felt exhausted, nauseated, numb.
The next day, Aug. 25, Quinn was declared brain dead. Irene decided to wait another day to turn off the machines so more family members could be there. Samuels was dreading it, but he had made a promise to be with them to the end.
Milstein, who will not talk about whether he plans to file suit on Irene Quinn's behalf, believes it's extremely difficult get truly informed consent from dying people such as Butch Quinn. They feel the drug or device being tested is their only hope. He calls it the "therapeutic misconception," the idea that people enter a trial to get well, when the true purpose is to test the device.
The Quinns, he said, "chose life over death. That's why they went into it. . . .But that isn't the reason to get the artificial heart and they [trial organizers] know that."
The couple, he said, should have been given more information about the bad things that could happen, including a detailed description of what went wrong when Barney Clark got a different version of the heart 20 years ago.
Potential patients, he said, should be told they will be subjects in an experiment, that the goal is not therapy, but altruism. It should not then come as a surprise in the end that, "you, the subject, have sacrificed your body, your last days, for their company, for the future of mankind."
Abiomed has always said it wanted this clinical trial to show not only if the machine worked but if it could improve quality of life.
Butch Quinn signed a lengthy informed consent document that called the trial an "initial feasibility clinical study." It warned of possible death, bleeding, blood clots, breathing problems and infection. Unlike a model consent form produced by Abiomed, it did not say, "This Study is Experimental."
David Casarett, the Quinns' first advocate, declined to comment. Nevertheless, in an essay last year in Newsday after the death of Robert Tools, the first patient, he wrote: "There were substantial risks of participation in this study, and the subjects knew all of them. The enrollment process was careful and deliberative, and each patient met with an advocate who helped him make what was, whatever his desperation, a difficult choice. Neither Tools nor Quinn, nor their fellow subjects, were fools."
Edward Berger, Abiomed's vice president for strategic policy and planning, said Irene Quinn's feelings about the trial are "understandable and at the core of human nature."
"When things go well, patients and their families are going to be extraordinarily happy," he said. "When things don't go well, it is absolutely understandable that patients or their family are going to be distressed."
He, Samuels, Holmes and hospital officials said there was little they could have done to improve the trial or the Quinns' experience. Berger said the funders had not prepared in advance for the possibility of a patient going home while still needing intensive nursing, but had agreed on who would pay by summer.
'He wasn't ready'
Butch Quinn was already dead when his family gathered in his hospital room for a peculiarly modern rite - turning off the machines that were making his heart pump and his chest rise and fall.
Encircling the bed and holding hands were Irene and other family members, Zink, Samuels and Holmes. Holmes, who had worked so long to keep Quinn alive, was worried she would fumble the procedure for turning his heart off.
A cousin, who looked strikingly like a younger, healthier Quinn, sang the Lord's Prayer. Irene Quinn broke the circle and stepped aside, the signal that she was ready.
Struggling to maintain his composure, Samuels gave the order to disconnect the ventilator and the heart simultaneously. Holmes scrolled through the commands, and hit the three buttons that would turn off the heart and override its internal, backup battery..
The room was silent for a second and then, in an alarming involuntary reflex that doctors say sometimes occurs in brain-dead patients, Quinn sat up, raised his arms with fists clenched, crossed them and fell back again.
Irene Quinn cried, "He wasn't ready," and sank, sobbing into Samuels' arms. She was sure Butch could not have been brain dead.
'He's in my heart and my soul'
Zink is now feeling "very reserved" about how far we can push the melding of man and machinery.
What she learned is that no one could have been fully prepared for what happened in this case. She does not believe the lack of advance planning for a possible discharge stemmed from a cynical view that that would never happen. "Everybody focused on saving his life. . . . Then it was kind of like, 'Then what?'"
She thought his medical care was excellent, but the hospital could have done more to support the Quinns emotionally. Samuels, whom she called a "role model," also needed more help. "Lou was just extraordinary in his dedication to them, his dedication as a surgeon and how accessible he was to them. He was their friend. He was their doctor. He was the case manager. He was everything."
Samuels hasn't gotten used to life without the man who consumed his thoughts for 10 months.
"I keep looking for him," he said. "I keep gravitating to Bed 18. There is definitely a sense of emptiness."
Would he go through it again? "I think, if the circumstances presented themselves with an appropriate situation and patient, I would very strongly consider it," he said, but he said it flatly, without enthusiasm.
Holmes says it's all too fresh. "You can't just say, "All right . . . Next? It's not like that."
Irene Quinn has put the gold urn containing Butch's ashes into an old, empty aquarium, where they're safe from the grandchildren and her rambunctious kitten. The urn is flanked by other mementos, including several presents from Samuels.
She prays every day that the Lord will take her anger away, but it hasn't happened yet.
"I'm angry. I'm mad. I'm pissed off. I don't even know how to say that I have so much anger and hurt," she said.
Their love is still with her and she wants it to stay, no matter how much it hurts.
"I love him so much. He's in my heart and my soul and my mind. . . . I look at [his] picture every day and I kiss it every day and I talk to him and hold it to my heart."
Contact Stacey Burling at 215-854-4944 or firstname.lastname@example.org.
Other artificial heart patients would do it again, their wives say
Two women whose husbands died while testing a new artificial heart said the men never regretted their decisions to join the clinical trial and would have done it again.
Both lived more than four months after surgery, but neither got well enough to go home.
"It was his choice, and he never said he was sorry," said Doris Harrison, whose husband Bobby, 68, had also tried a new type of defibrillator in 1992.
Carol Tools said her husband, Robert, the first patient to receive the AbioCor heart in July 2001, would have volunteered for the surgery again "in a minute."
"For the most part, I was really thrilled and he was too, to be part of history," said Tools, who lives in Kentucky.
Both women lived more than a hundred miles from the hospital. For five months, Doris Harrison slept in a chair at her husband's bedside at the Texas Heart Institute at St. Luke's Episcopal Hospital. Carol Tools lost her job.
The experience was hardly fun, but both felt their husbands enjoyed extra time. They said they understood the risks.
Harrison said she wouldn't choose to get the artificial heart herself. But she would support her husband again, knowing what she knows now, and she would feel comfortable recommending it to another wife. "There's a lot to go through, but life is a challenge," she said. "You have to take those challenges if you want to live."
Tools said she talked to Tom Christerson and his wife before he had the surgery. Christerson is the only one of the first patients who is still alive. Her biggest piece of advice: Make sure you go to the ICU and see what someone who's been through major heart surgery looks like. The swelling and machinery can be terrifying.
Tools didn't really expect her husband to survive the operation, but she knew how much he wanted to do something valuable for mankind. In reality, Robert Tools felt considerably better after surgery than he had before - until the stroke three weeks before he died.
"It extended his life," Carol Tools said. "It gave him a better quality of life. It accomplished its goals as far as I'm concerned."