On Medicine's Frontier: The Last Journey of James Quinn
By SHERYL GAY STOLBERG
NY Times 10/08/02
PHILADELPHIA - On the day his doctors disconnected his artificial heart, ending his life, James Quinn gave them one final scare.
It was Aug. 26, nearly nine months after Dr. Louis E. Samuels, a transplant surgeon at Hahnemann University Hospital here, removed Mr. Quinn's diseased heart and replaced it with a mechanical one, turning the 52-year-old retired baker into a research pioneer. Now, with his patient brain dead after a stroke, Dr. Samuels was presiding over the unplugging of the device that had kept Mr. Quinn alive longer than anybody dared hope - perhaps, both he and his surgeon thought, too long.
Mr. Quinn's room on the eighth-floor cardiac intensive care unit was crowded with family members and medical people by the time Dr. Samuels arrived. A cousin sang the Lord's Prayer. A minister spoke briefly. When Mr. Quinn's wife, Irene, said, "It's time," Dr. Samuels motioned to his nurse practitioner, who deprogrammed the external console that powered the heart.
Without warning, Mr. Quinn bolted upright, arms extended, as if reaching toward the heavens, then crossed his hands and lay back down. The scientist in Dr. Samuels recognized it as an involuntary reflex, yet he could not help wondering if Mr. Quinn, a deeply spiritual man, was "reaching out to God." Irene Quinn was horrified.
"You're killing him!" she remembers shrieking. "He wasn't ready!"
Mr. Quinn's final gesture marked the last, awful moments in an experiment that ethicists say raises serious questions about the participation of dying patients in medical research. By the standards of the Food and Drug Administration, which oversees the trial, the experiment was a success - Mr. Quinn survived more than 60 days with his new heart, more than twice as long as he was expected to live when he received it.
But his quality of life was poor. In an interview shortly before the stroke that killed him, Mr. Quinn, known as Butch, said that if he had to do it all over, he would stick with his natural heart.
"This is nothing, nothing like I thought it would be," he said. "If I had to do it over again, I wouldn't do it. No ma'am. I would take my chances on life."
When doctors experiment at the frontiers of medicine, no one can say at the outset how the research will end. Doctors may warn patients of debilitating side effects and even death, but nonetheless, experts say, patients often fall prey to "the therapeutic misconception," the idea that if a doctor offers a treatment, it must have therapeutic value.
"These people get to the point where they are willing to try anything," said Dr. Judith P. Swazey, a medical historian who has done extensive research on the artificial heart. "When they are in that position, I'm not sure how informed informed consent can be."
Mr. Quinn's experience, pieced together from interviews with him and his family, his doctors, his patient advocate and officials at Abiomed, the Danvers., Mass., manufacturer of the heart, provides a rare glimpse inside the choices made by a dying patient and his physician. It also provides a peek behind the scenes of the highly publicized artificial heart experiment, which has enrolled seven patients since July 2001.
Of the seven, the only one still alive is Tom Christerson of Central City, Ky., who on Sept. 13 celebrated his first anniversary with the Abiomed heart. He is living at home, relatively normally, his doctors say. But experts who have studied a previous artificial heart experiment, the Jarvik-7, say Mr. Christerson is an exception. Mr. Quinn, they say, is more the rule.
"The artificial heart has always been a device treated as kind of a miracle machine," says Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "So there has been a pattern of hope and disappointment, hype and almost battling between subjects, families and researchers."
In Mr. Quinn's case, Dr. Samuels wound up searching for "some solace, some reason to believe it was still worthwhile."
Ed Berger, the spokesman for Abiomed, acknowledges Mr. Quinn did not meet the company's goal: "six months of reasonable quality of life."
And Mr. Quinn, who said he only wanted more time with his wife and grandchildren, was deeply frustrated that he never got well enough to leave the hospital for home. Months before his death, he hired a lawyer, thinking he might sue.
This is the story of Mr. Quinn's second chance. It is the story of the conflicted bond between a surgeon seeking to "offer people without hope some hope" and a patient caught up in what Dr. Caplan calls "the conspiracy of optimism" that surrounds medical research.
The Technology: Mission to Build a Better Heart
Lou Samuels has always been fascinated by technology. Growing up on Long Island, he said, he collected newspaper accounts of the landing on the moon. As a college student in the early 1980's, he followed with awe as Dr. Barney Clark, a Seattle dentist, became the first person ever to receive an artificial heart, the Jarvik-7. Now 40 and a professor at the Drexel College of Medicine, Dr. Samuels describes himself as "absolutely bitten by the bug of the beating heart and the correction of its maladies."
Unlike the cumbersome Jarvik, which relied on an external power console the size of a small refrigerator, the Abiomed heart, called AbioCor, is a grapefruit-size machine that is entirely implanted in the body. The patient wears an external battery pack, about the size of a videotape; the heart also has an internal battery that lasts from 10 to 30 minutes. An external power console can be used as backup. With human hearts in scant supply for transplants, as many as 10,000 Americans each year could benefit from such a device, officials at the National Institutes of Health estimate.
The AbioCor grows out of a directive from Congress, which in the 1960's ordered the N.I.H. to work on a replacement heart. Agency officials say they have given Abiomed $12 million to $15 million in grant money since 1981. The company's president, Dr. David Lederman, has said the heart fulfills "a national mission."
Dr. Samuels has been preparing to join that mission since the mid-1990's, he said, but financial troubles at Hahnemann, culminating with a bankruptcy filing in 1998, prevented him from participating in the early animal research. When the hospital was taken over by Tenet Health Systems, a for-profit company, he was permitted to proceed.
By the time Butch and Irene Quinn turned up in Dr. Samuels's office one year ago, the surgeon had perfected implanting the AbioCor in pigs, and his transplant team was looking for eligible patients. They would need someone within 30 days of death, too old or too sick to qualify for a transplant, with a chest big enough to house the AbioCor.
Though only 51, Mr. Quinn's nine-year history of heart disease was complicated by irreversible high blood pressure; he was tethered to an intravenous device that pumped heart drugs into his blood.
A tall, strapping man with deep eyes and a hearty laugh, he had served in Vietnam and later became deeply committed to Christianity. His wife, slender and small-boned, worked as a nurse's aide and helped him meet the trial's requirement for good family support.
Dr. Samuels showed the couple a video that depicted the artificial heart pumping water, a scene Mr. Quinn recalled before he died. "I said, `My goodness, if this is pumping this way in water, when it gets in me and pumps blood, it's really going to be something.' "
Mr. Quinn liked the idea of being a research pioneer. "That was my way of contributing," he said, "to put my name in the book of life, with Jesus Christ." Still, he worried about giving up his human heart. "I asked my wife, `Am I going to feel the same things that I feel now? Am I going to feel that I love you with all my heart?' "
The Choice: A Family Gets a Chance at Hope
Ethicists say an artificial heart experiment is different from any other. As Dr. Caplan said, "You are going on a voyage where a core right - the right to withdraw from the experiment - requires the researcher to end your life."
To navigate these complex waters, Abiomed created a council of independent ethicists to advise the company and serve as patient advocates. The Quinns' advocate was Dr. David Casarett, a geriatrician at the University of Pennsylvania. He sat in when Dr. Samuels went over the trial's informed consent form, a 14-page document that bluntly outlined the experiment's risks, from death on the operating table to "pressure from the media" - a problem the company remedied by imposing a 30-day news blackout after each surgery.
Dr. Casarett declined to be interviewed, citing the council's rule against speaking to the press. But Dr. Samuels says he was clear.
"I presented a very balanced picture," he said. "This is something that we didn't have before. We don't know how it is going to work out." Still, he remembers Mr. Quinn "lighting up at the idea that there was some hope."
Mrs. Quinn recalls that she and her husband were intent on saving his life. "It was like a do-or-die situation," she said. "The device could save your life, or you die."
Medical ethicists - along with the Quinns' lawyer, Alan Milstein - say the Quinns' situation is a classic example of the "therapeutic misconception." Dr. George Annas, a professor of health law at Boston University, argues dying patients are "coerced by their disease" into participating in research.
But Dr. E. Haavi Morreim, a University of Tennessee bioethicist who is chairman of Abiomed's ethics council, disagrees. "To assume that no one who is facing mortality is capable of thinking reasonably," Dr. Morreim said, "is an insult."
The Recovery: Some Success, Some Setbacks
On Nov. 5, 2001, Mr. Quinn became the world's fifth recipient of an AbioCor heart. The 10-hour surgery, led by Dr. Samuels, involved a 30-member team of doctors, nurses, scientists and engineers. When it was over, doctors put up side-by-side X-rays of Mr. Quinn with his old heart and his new one.
"The entire place got totally quiet," said Dr. Sheldon Zink, a medical anthropologist who had been chronicling the trial. "It was like, `Oh my God. He has an artificial heart.' "
Right away, though, Mr. Quinn suffered a serious complication: his lungs filled with fluid, and doctors, fearing he would die, placed him on an external oxygen machine. The problem, which cleared up, was an important test for the heart, which "worked and kept working," said Mr. Berger, the Abiomed spokesman.
Inside the hospital, the Quinns - their identities still unknown to the public - were celebrities. Dr. Samuels, describing himself as "very overprotective," slept in the intensive care unit and installed a baby monitor in Mr. Quinn's room; he later likened the experiment to giving birth. A private living room, with a sofa and love seat, was set up to create a homelike environment.
By Thanksgiving, Mr. Quinn was not only walking, but also riding a stationary bike. "We were astonished," Mr. Berger said. Elena Holmes, the nurse practitioner who supervised Mr. Quinn's care and rarely left his side, cooked a big turkey. Dr. Samuels wrote the couple a note, thanking them for changing his life.
On Dec. 6, Dr. Samuels introduced his patient to the press. In the middle of the news conference, Mr. Quinn's young grandson ran onstage to give his grandfather a hug. "I couldn't have staged it better if I was a Hollywood producer," Dr. Samuels said. "It was just so beautiful. And he looked fantastic."
On New Year's Eve, Dr. Samuels said, he brought a bottle of Champagne to the hospital. Instead of celebrating, Mr. Quinn suffered a small stroke, a complication that Abiomed later said might have been caused by blood clots forming on struts in the device. The company subsequently redesigned the heart. Mr. Quinn, meanwhile, was given a higher dose of blood thinners to prevent the formation of clots.
By mid-January, Mr. Quinn was well enough to leave Hahnemann - not for home, but for a nearby hotel, the Hawthorn Suites, where two rooms had been set up to resemble the intensive care unit. Abiomed technicians were on hand during the day to respond if the heart's battery malfunctioned or the console issued an alarm. Ms. Holmes, the nurse practitioner, stayed with the Quinns at night.
The move was intended to help Mr. Quinn make the transition from hospital to home. But it would prove a turning point, both physically and psychologically, for the couple.
Mr. Quinn developed lung problems, was readmitted to the hospital on Feb. 3 and went on a breathing machine. He was weary of being poked and prodded, he later said, and at times felt "excruciating pain." Dr. Zink, the medical anthropologist, says the setback left Mr. Quinn feeling vulnerable.
"He was fearful," she said, "that when he took a downward spiral, he wasn't going to be the poster boy for Abiomed anymore."
Mrs. Quinn, frustrated and exhausted, grew angry that Hahnemann had not provided around-the-clock nursing care at the hotel. She was also worried about money. Hahnemann kept sending her bills. They were sent in error, hospital officials said, but she feared she would have to pay them. "I didn't have anybody to talk to," she said. "I didn't trust anybody."
As her husband grew ever more dependent on her, Mrs. Quinn said, she quit her job. Some nights, she stayed in the hospital, her tiny body curled up on the window seat in Mr. Quinn's room. "I'm crying all the time," she said in August. "I feel like my life isn't mine any more, like his life isn't his."
Dr. Annas of Boston University said Mrs. Quinn's despair was not unique. Barney Clark's wife, he said, also suffered greatly. "This is an experiment on the family," Dr. Annas said. "There are a lot of lessons we should have learned from the Jarvik, and I don't think Abiomed and their doctors learned them very well."
In March, the Quinns hired Mr. Milstein, the lawyer, who had come to prominence when he represented the family of Jesse Gelsinger, a teenager who died in a gene therapy experiment at the University of Pennsylvania. In June, with Mr. Quinn increasingly eager to go home, Mrs. Quinn asked Dr. Zink to become the couple's new patient advocate - independent of the Abiomed board.
Getting Mr. Quinn home, Dr. Zink says, was her highest priority. "Lou was openly saying, `We are not doing anything for him clinically in the hospital,' " she said, referring to Dr. Samuels. "So why couldn't he leave?"
The answer, in part, lay in the Quinns' home, in a forlorn section of West Philadelphia. The couple had no living room furniture, so Dr. Samuels made a gift of the sofa and love seat they had used in the hospital, delivering them himself one weekend afternoon. There was no air-conditioner, Dr. Zink said, and the wiring was faulty. "Here's a guy who has an artificial heart; the internal battery lasts 11 minutes," Dr. Zink said. "That's a scary thing."
Dr. Michael Berman, the F.D.A. official overseeing the trial, says the agency strongly urged Abiomed to require home environmental reviews before patients left the hospital. But Mr. Berger of Abiomed said company officials "did not do an enormous amount of preparation or preplanning," in part because they did not really expect the first patients to go home.
Also at issue was who would pay for Mr. Quinn's home nursing care. But, Mr. Berger said, the financial agreement between Abiomed and Hahnemann did not address who should pay - an omission that Dr. Zink said infuriated her.
By August, Abiomed had agreed to absorb the cost "for a certain period of time," Mr. Berger said. Ms. Holmes was trying to train new help. Mr. Quinn began making occasional visits home, which lifted his spirits greatly. On Aug. 15, he sat in his living room, on the new couches Dr. Samuels had brought, and nibbled on a cheese steak sandwich prepared by his wife.
"I want to come home and stay home, come home and be with my grandchildren, with my wife," he said. "They say there's possibilities, that the pump works so good, I could maybe live another 20 years if the rest of my body holds up."
Eight days later, Mr. Quinn suffered a massive stroke. Two days after that, he was declared brain dead.
The Aftermath: Lingering Anger Over Suffering
Butch Quinn's funeral took place just after Labor Day in the brick-and-stone church he and his wife had attended for years. Dr. Samuels and Ms. Holmes were there; although the surgeon wanted to deliver a eulogy, Irene Quinn politely turned him down. A military honor guard played taps, and presented Mrs. Quinn with the flag draped over her husband's coffin. The minister praised Mr. Quinn's faith. The altar was decorated with huge sprays of flowers from Hahnemann and Abiomed. Yet in nearly two hours of song and prayer, the words "artificial heart" were never spoken.
Mr. Berger said Abiomed was grateful to Mr. Quinn, who helped demonstrate the heart's reliability. He said the company hoped to enroll eight more patients in the artificial heart trial by the end of this year and intended to ask the F.D.A. to permit "limited commercial distribution" of the heart in 2004.
"You can say, `Look what we achieved, it's positive,' " Mr. Berger said. "That is something you feel very good about. On the other hand, we want our patients to do well, and to feel that they are doing well." In that regard, he said, Mr. Quinn's story "is distressing."
Dr. Samuels is not certain whether he will have another artificial heart patient. On the day he ordered Mr. Quinn's heart stopped, he said, he tried to focus on their good times - the Thanksgiving turkey dinner, the grandson who ran onstage for a hug. "All I could think," the surgeon said, "was that at least I had a chance to see him at home, to interact with his grandchildren and family."
Irene Quinn remains angry. Of her husband, she said, "He would have been better off dead. He wouldn't have suffered."
During Mr. Quinn's autopsy, the artificial heart was removed and sent back to Abiomed for an examination. Mrs. Quinn, aware of this, made a request of Dr. Samuels, one that he says he fulfilled. She asked the surgeon to find whatever was left of Mr. Quinn's original heart, and to put it back inside his chest.
In death, she wanted her husband to have a human heart.