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As the months dragged on and Clark deteriorated, the university tried to pull back on the media front. It was too late. Barney Clark’s story became one of dashed hope as it became painfully clear that American know-how couldn’t do for the human body what it had done for space exploration. It didn’t help that Clark’s surgery took place in the post-Watergate era. Bob Woodward and Carl Bernstein had brought down a president with their reporting on the Watergate scandal in 1972, and now a new generation of hungry investigative reporters was focused on Utah.
At the same time, the new field of bioethics was expanding, largely because of the ever-growing intersection of technology and medicine. Congress had passed the National Research Act in 1974 in response to some highly unethical experiments on humans, in particular the infamous Tuskegee, Alabama, syphilis experiment of 1932–1972, in which 408 impoverished black men with syphilis were never treated, only observed, as they died. Part of the act included the creation of Institutional Review Boards, like the one in Salt Lake City, which were supposed to protect patients who agreed to be involved in scientific research. Now physicians weren’t the only ones with the power to make life-and-death decisions. Their authority would be questioned even further with the establishment of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, issued just before Clark’s surgery.
Not coincidentally, the commercialization of medical care was also a big issue at the time. Everything from the exceedingly generous public contributions to help defray the Clark family’s medical bills to the University of Utah’s use of PR as a fundraising tool for more implantations came under the microscope, as did the exclusive rights given to the German magazine Stern for the Clark story, for which the magazine paid $100,000. (“The astronauts sold their story for $500,000 to Life magazine,” one hospital official groused.)
Then there were the problems with Kolff Medical. It was not widely known that in 1976 Kolff, Jarvik, and several associates had formed an independent company to market their artificial heart and its accompanying compressor. In fact, Jarvik had become so adept at raising millions in venture capital that he ended up in charge, elbowing Kolff out of the way and renaming the company Symbion. DeVries and the university were also stockholders, which raised significant conflict-of-interest issues.
The Institutional Review Board came under scrutiny too, as reporters uncovered more information about its decision-making process, particularly the disagreements between the doctors and the engineers over the readiness of the Jarvik heart. That eleven-page consent form presented to the Clarks was dismissed by one prominent ethicist as ridiculous. A University of Alabama ethicist called it “fishy.” Was the Utah team trying to heal the sick, or was it just trying to continue a medical experiment of dubious value? Two major American sociologists, Judith P. Swazey and Renee C. Fox, conducted an independent investigation of the affair; in a book based on their research, Spare Parts, they wrote that putting the artificial heart in Barney Clark had been “fundamentally unethical” and “profoundly disquieting,” characterized by “dangerous excesses” and “misconduct.”
Things got so bad that a major symposium was held in 1984 to examine in excruciating detail the legal, ethical, medical, commercial, and journalistic sins that resulted from Clark’s surgery.
But it was Barton J. Bernstein, the prominent Stanford historian, who was probably the most damning, declaring that “instead of being allowed to die peacefully,” Clark “had undergone a series of painful procedures in full view of the public.” More important, “there was no evidence that the massive federal investment in artificial hearts would ever truly improve the quality of life of patients.”
Under cover of night, DeVries and his family moved to Louisville in 1984, where he joined the staff of a Humana hospital. The University of Utah was rethinking its commitment to the artificial heart program, and like Cooley before him, DeVries had been getting death threats. “Artificial Heart Surgeon William DeVries Transplants Himself to Greener Pastures,” was the way People magazine described the move.
DeVries put it differently, saying that he was tired of watching “people die while I wait for the red tape.” He would never waver in his belief that any kind of life was preferable to death, but it was becoming increasingly difficult to convince the federal government, and the public, that he was right.
9
THE PRISONER
By the 1980s, Bud had made a name for himself as both a tireless transplant surgeon and a relentless researcher. A colleague from the University of Texas had recommended him for appointment to a National Heart, Lung, and Blood Institute (NHLBI) advisory committee with the incoming Reagan administration, which, thanks largely to the Barney Clark debacle, was fast losing interest in funding total artificial hearts. A government study released in May 1982—prior to Clark’s surgery—showed that Cooley’s implantations had also had an influence, as had the reports from ethicists who had criticized those surgeries. There was mention of technical difficulties being greater than anticipated. No one seemed to know how to design and produce certain crucial components. There were still problems with blood destruction and the power source. “Estimates as to when a totally implantable artificial heart system capable of long term support will be achieved are uncertain. The most common forecast is ‘many years away’,” the study concluded. Then came the death watch for Clark.
In 1985, the director of the NHLBI canceled all federal funding for artificial heart research in favor of work on LVADs. After all, wasn’t half an artificial heart better than none at all?
Over time, with more experiments and more testing, Bud and Vic Poirier began developing an LVAD that was portable—meaning a person could actually leave the hospital without dragging around an enormous console. They wanted the device to be electrically powered instead of air powered, and its outer workings small enough to be stored in something about the size of a backpack. Given the state of the technology at the time, success seemed unlikely, but by 1991 they thought they had something that worked, and Bud also had a patient willing to give it a go.
Mike Templeton was a very young but very sick man. He was thirty-two years old, from the north Houston exurb of Humble, and by the time he got to the Texas Heart Institute, he had only two choices: gamble with an experimental device or let death take him within the next day or two.
Like so many people with heart disease, Mike’s problems developed very slowly and then accelerated with an almost frightening speed. Just two years or so before, he had been a strapping young man, a high school graduate who stood six feet tall and weighed 200 pounds, most of it muscle put on while he worked as a pipeline technician in the oil fields. He wore his straight brown hair brushed off his broad, open face, and aviator-style eyeglasses. His brushy mustache slipped down over the edges of his lips, suggesting a perpetual frown, but something gentle behind his eyes mitigated even a hint of disapproval or disdain. By nature, Mike was a happy-go-lucky guy who didn’t want for much. He desperately loved his feisty wife, Tara, and his two daughters, Shana and Jenna.
One day he got a cold that wouldn’t go away. At night, he tossed and turned with watery congestion in his chest. When he started coughing up blood, Tara demanded he see a doctor.
That’s when he got the bad news. Mike had something called idiopathic cardiomyopathy; his heart muscle had become enlarged and thickened, and it was no longer strong enough to pump blood through his body. The cause was unknown. The doctors told him he needed a transplant immediately.
He stayed in the local hospital for three weeks and convinced himself that he would be all right with medication. He went home and managed to work a little, but the deterioration continued over the next few months. He was bloated, nauseated, and, again, coughing up blood. That time, Mike got as far as the hospital steps before he blacked out; the next thing he knew, he woke up in another place, St. Luke’s. Doctors at th
e Texas Heart Institute got him stabilized and put him on the transplant list. He went home to wait.
After another near-fatal collapse—by then Mike’s liver and kidneys were failing too—he was rushed back to St. Luke’s via emergency helicopter. There he met Bud Frazier, who provided him with one more option: the new LVAD they had been working on in the lab. Bud was honest: they had tried the device once before, and the patient had died.
Mike was almost too weak to sign the consent form. “There must have been sixty pairs of eyes looking at me,” he told Houston Chronicle reporter Claudia Feldman. “It was quite a day. The staff told me they were going to film the operation. They said they weren’t going to let me die—I was going to be on TV.”
When he woke up, Mike felt better than he had in years. He sat up the next day, and walked a few paces down the hall, the power pack slung over his shoulder, the sss-boom, sss-boom of the machine pulsing just above a whisper. He was stunned to the point of tears when he discovered soon after that that he could play basketball, and beat his brother Richard in a footrace.
The only downside was that Mike did both those things inside the confines of St. Luke’s. The FDA had added another stipulation when it had approved emergency implantation of the new HeartMate: the device was approved as a one-time-only bridge to transplantation. Mike would not be allowed to leave the hospital until a donor heart was beating in his chest. As Frazier knew, this could take a long time: his patient was a large man, and his blood type, O positive, was the most common, which meant that the wait time for a donor heart would be the longest. (Hearts from donors with type O blood can also go to recipients with other blood types.) In the meantime, the US government required that Templeton be kept safe with an approved escort every time he left the hospital floor. Leaving the hospital itself was out of the question. Who knew if or when the pump would give out?
For a while, the rules didn’t matter. Mike became something of a celebrity, since news of his surgery was reported worldwide. Strangers asked to be photographed with him in the St. Luke’s lobby. Doctors asked how he was feeling. And he was so grateful to see his family. Mike seemed to have his life back, or at least he believed that he would soon. But as money grew tight without his income, he and Tara began to fight more. And as time passed, his growing girls grew less and less willing to spend their free time at the hospital. He was like an astronaut walking in space, tethered to the lifesaving mother ship but cut off from all he knew. At times he thought about making a break for it—just walking out of the hospital and taking his chances. But he realized that would leave Bud in a bind, and he couldn’t do that to the man who had saved his life. Mike thought too about all the people whose lives could be saved with the device keeping him alive. He couldn’t let them down either.
In fact, Frazier, Poirier, and even Cooley were furiously lobbying the FDA to release Templeton from bondage. But the answer was always no. The doctors could see Templeton was mentally deteriorating. As his time in the hospital closed in on a year, the light in his eyes faded, he shuffled, and he spoke in a monotone. His anxiety kept him awake at night, and he began to haunt the floor in the dim twilight of the hallway. He looked, in short, like a man who had stopped caring whether he lived or died. The option of a transplant terrified Templeton as well; he didn’t think he could endure another medical procedure, especially as he watched many other patients leave the hospital and then come back sicker than before. And he hated the idea that someone else had to die so that he could live. “I didn’t bargain for all this,” he told the Chronicle. “But I want to see my girls grow up.”
Finally, in September 1992, the FDA relented and Mike Templeton was free to go back home to Humble. He had spent more than a year in the hospital and would be remembered in the medical literature as the first patient in history to leave the hospital with a portable HeartMate I. He was alive and untethered.
But leaving the hospital is not the same as going home. The life Templeton remembered and so desperately craved to return to was gone. He had been a strong man who cared deeply about providing for his family; now they were providing for him, and the emotional and financial drain seemed, to him, insurmountable. Four months later, he stopped taking the medication that kept his blood from clotting. Almost immediately, he suffered a fatal stroke.
“The pump worked fine,” Bud told the press. But Templeton’s heart was completely broken.
Bud Frazier as a high school football star in West Texas, 1950s. (Courtesy of Dr. Frazier)
Frazier was a flight surgeon in Vietnam from 1968 to 1969 but spent his free time treating local villagers. (Courtesy of Texas Heart Institute)
Michael DeBakey at his wife’s sewing machine, where in the 1950s he created a revolutionary vascular graft. This photo was staged for posterity. (Courtesy of Baylor College of Medicine Archives)
A Texas Heart Institute operating room in the 1960s. At the time, THI performed more heart surgeries than any place in the world. (Courtesy of Texas Heart Institute)
Denton Cooley bedside in the 1970s. (Courtesy of Texas Heart Institute)
Denton Cooley implanting the artificial heart designed by Domingo Liotta, 1969. (Courtesy of Texas Heart Institute)
Bud Frazier with noted British heart surgeon Dr. Stephen Westaby (far left) and Dr. Robert Jarvik, inventor of the artificial heart implanted in Barney Clark in 1982. (Courtesy of Dr. Frazier)
Seattle dentist Barney Clark lived for 112 days with the Jarvik-7 artificial heart. He is pictured here with his surgeon, William DeVries. (Courtesy of Spencer S. Eccles Health Sciences Library, University of Utah)
Calves have been used in the majority of artificial heart experiments because their biology is the closest to that of humans. (Courtesy of Dr. Frazier)
Bud Frazier with patient Mike Templeton, 1991. Templeton was the first patient to leave the hospital with a left ventricular assist device, the modern version of which has been implanted in 40,000 people. (Courtesy of Texas Heart Institute)
Drs. Frazier and Cooley with Craig Lewis, who lived for five weeks with two HeartMate II’s put together. (Courtesy of Dr. Frazier)
Bud Frazier and Billy Cohn with their total artificial heart made by combining two HeartMate II left ventricular assist devices, circa 2011. (Courtesy of Texas Heart Institute)
Billy Cohn and Bud Frazier describing their work on artificial hearts at TEDMED conference, 2012. (Courtesy of Texas Heart Institute)
Australian biomedical engineer Daniel Timms holding the Bivacor, 2016. (Courtesy of BIVACOR Inc./Texas Heart Institute)
A portion of Timms’ global Bivacor team in the THI lab, 2016. (Courtesy of BIVACOR Inc./Texas Heart Institute)
Bud Frazier’s hand holding what could be the culmination of his lifelong dream, an artificial heart that might one day be mass produced to save tens of thousands of lives. (Courtesy of Texas Heart Institute)
Mattress Mack, aka Jim McIngvale, in the 1980s. The furniture store mogul and philanthropist is an investor in the Bivacor. (Associated Press)
Bud Frazier in repose in West Texas, 2016. (Courtesy of Marianne Mallia)
10
THE WILDERNESS
In retrospect, there were several interesting and important developments that emerged from the Templeton case. Yes, in 1994, the FDA approved pneumatically driven devices like the HeartMate I for use as a bridge to transplantation. But the most interesting and important thing might have been that Bud decided that a machine that kept a person alive by mimicking the pumping action of the natural heart wasn’t the best idea for an artificial heart—even if the HeartMate’s latest iteration was good enough to allow a patient to play tennis. That was typical of Bud, but just about everyone else in the medical community thought his alternative was crazy.
So was his timing. Since the late 1980s, the public and politicians
had been trying to wash their hands of the whole idea of a totally implantable artificial heart. Everyone from members of the Reagan administration to prominent academic bioethicists was losing faith. There were several reasons for this. First, society at large didn’t seem as enthralled with the miracles of the medical profession anymore; the Barney Clark media pile-on had certainly given that viewpoint a boost. So too did the so-called Baby Fae case, in which a doctor successfully transplanted a baboon heart into a human infant who lived for two weeks in 1984, setting off another ethical furor. Much closer to home but no less controversial was the death of the “Bubble Boy,” David Vetter, that same year; he was more or less incarcerated with a rare autoimmune disease in a Texas Medical Center hospital from his birth in 1971 until he died at the age of thirteen. Were doctors trying to heal the sick or just experimenting on defenseless people for the most narcissistic of reasons? Or, maybe, both?
Then there was the issue of cost. The deep recession of 1980–82 was followed by deep cuts in social spending and general belt tightening for everyone. Stanford historian Bernstein took up the charge again. “Can America afford to develop a workable artificial heart?” he asked in an article in The Nation, suggesting that the cost of serving the “16,000–66,000 potential recipients”—a pretty broad spectrum—would range from $1.6 billion to $6.6 billion at a time when the federal deficit was approaching $200 billion. And given the ongoing but less than successful experiments with the Jarvik heart—the misery played out in public with five more patients over the next few years—people began to wonder how much better life with an artificial heart was than simply living out whatever time they had left with the faulty heart they’d been born with.