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.
