Journal of the History of Medicine and Allied Sciences

Journal of the History of Medicine and Allied Sciences Advance Access originally published online on June 20, 2009
Journal of the History of Medicine and Allied Sciences 2010 65(1):48-80; doi:10.1093/jhmas/jrp020

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Enemies or Allies? The Organ Transplant Medical Community, the Federal Government, and the Public in the United States, 1967–2000

Mary Jo Festle^*

Correspondence: ^* History and Geography, Elon University, Campus Box 2335, Elon, North Carolina 27244. Email: festle{at}elon.edu.

	ABSTRACT

TOP ABSTRACT NOTES

 
The transplant medical community in the United States has frequently been divided over the appropriate role of the federal government and of the public in matters related to organ transplantation. Using public statements in government hearings, newspapers, and press releases, this article traces the thinking of the transplant medical community in particular during three especially politicized periods: the heart transplant and brain death controversies in the late 1960s, consideration of the National Organ Transplant Act and other legislation during the mid-1980s, and the controversy over organ allocation regulations issued by the Department of Health and Human Services in the late 1990s. Even while sometimes denouncing "politicization," over time surgeons, physicians, representatives of the United Network for Organ Sharing, and other leaders in the field became increasingly politically active and more accustomed to the notion that because of the unique nature of organ transplantation, both the public and the federal government have a legitimate and potentially beneficial oversight role.

Key Words: organ transplantation policy • organ transplant community • United Network for Organ Sharing • U.S. Department of Health and Human Services • National Organ Transplant Act

Liver surgeon Anthony D'Alessandro wrote an impassioned opinion piece in the Washington Times on 16 March 2000, a day he said organ transplant patients and their doctors in the United States had been trying to stave off for almost two years. On that date, regulations issued by the U.S. Department of Health and Human Services (HHS) would go into effect. D'Alessandro characterized the regulations as a "hostile takeover of America's transplant system," which had been run since the 1980s by the United Network for Organ Sharing (UNOS), a nonprofit organization contracting with the government. He held Donna Shalala, Secretary of the Health and Human Services, responsible for this disaster: "Miss Shalala is determined to anoint herself federal organ transplant czar." As a result, "political appointees" would make the final decisions about who lives and who dies that previously had been reached by consensus among transplant doctors. "Instead, we have Donna Shalala and her cynical, sound-bite political meddling," asserted D'Alessandro. "The doctor is out and Miss Shalala will decide what is good for us. We do not know, of course, exactly what policies she will choose to impose, or how often or on what whims they will be changed."¹ Not surprisingly, Donna Shalala characterized HHS actions and the regulations quite differently—as responsible guidelines to insure fairness and consistency for all transplant patients, which still left specific decisions about how to allocate organs in the hands of medical experts in UNOS.

D'Alessandro's letter effectively captures the intensity of a controversy in the mid- and late 1990s. The heart of the battle over HHS regulations was about how to allocate the nation's scarce organs for transplantation, but an important subtheme was the role of the federal government in that process. D'Alessandro did not mention that other surgeons and patients had urged the U.S. Department of Health and Human Services to step in and issue regulations and that they agreed with the substance of the regulations. Clearly the transplant community² in the United States was divided, and this ambivalence about the role of the government dated back to discussion about early heart transplants and brain death in 1968, when some surgeons welcomed and others feared the involvement of the government and outsiders. The interest of national politicians and the accompanying ambivalence from the transplant medical community surfaced again in the mid-1980s when organ transplantation enjoyed a resurgence and again captured the public eye. The third and most heated period of national government involvement was in the late 1990s. By then, both sides in the organ allocation dispute criticized the "politicization" of the debate, but at the same time both sides were using shrewd political tactics and looking to officials in the federal government to take their side. The federal government has been involved in organ transplantation to a degree that is unusual in American medicine, but in retrospect, neither the politicization nor the role of the federal government are surprising given the special needs and characteristics of this unique medical procedure.

In December 1967, South African Christiaan Barnard's first transplant of a human heart captivated the world.³ Newspapers and television reported every positive detail of the "miracle in Cape Town" and Barnard became an international celebrity. Reporters deemed him "a young revolutionary who had changed the whole nature of cardiac medicine" and the "greatest physician of the age."⁴ Only a handful of surgeons had already been doing extensive research and animal experimentation on heart transplantation; hoping to replicate Barnard's feat and gain the same notoriety for themselves or their countries, scores of others around the world suddenly seemed to "jump on the bandwagon." In 1968 alone, 101 heart transplants were performed by sixty different medical teams in twenty-two nations, some of which did not have much experimental or other relevant background.⁵ Many did just one or two transplants, but Denton Cooley in Houston performed seventeen in 1968. Adrian Kantrowitz, a heart specialist at New York's Maimonides Medical Center with years of transplant experimentation behind him, performed the first human heart transplant in the United States. He was shocked by the "frenzied interest" of over two hundred insistent journalists who appeared in the middle of the night when someone leaked news of his surgery. Patients with heart disease, not realizing the experimental status of the procedure, soon crammed the hallways of some U.S. hospitals, hoping that star surgeons might perform miracles on them.

The positive glow soon wore off, however. The results of the early heart transplants could not match the media hype. Although Barnard's second recipient lived over nineteen months, even the well-prepared teams of Adrian Kantrowitz and Norman Shumway at Stanford had bad outcomes. Kantrowitz's first patient, a seventeen-day-old infant, lived for only a few hours. His second survived just eight hours. Shumway's first patient lived fifteen days, but struggled with internal hemorrhaging and underwent two additional surgeries in those two weeks. Only three of Denton Cooley's seventeen patients lived more than six months. Indeed, only forty-seven of the first 140 heart recipients lived more than three months after the surgery, and there was a dismal 22 percent one-year survival rate. For the typical recipient who lived a few months, the quality of life left much to be desired.⁶ At the same time, other physicians criticized the "circus atmosphere" surrounding the procedures and the rise of "surgical show biz."⁷ They feared that surgeons lured by "the glamour that surrounds them" were losing sight of the well being of their patients.⁸ A number of prominent cardiologists called for a moratorium on heart transplantation, emphasizing that the odds of success were slim because although surgical techniques were advanced, there was not sufficient immunological understanding to prevent rejection of transplanted hearts.⁹ "Surgeons love to show they can do things," observed an administrator from the National Institutes of Health, "but there is a morality gap in doing those things before there is good enough scientific base." The media picked up on the criticism. Newspapers printed "box scores" on the outcomes of all the heart transplants, illustrating their high mortality rates. "Were Transplants Premature?" asked Time magazine. "Hasty Hearts?" asked Newsweek.¹⁰

The heart transplants were on Senator Walter Mondale's mind when in February 1968 he proposed a one-year National Commission on Health Science and Society to investigate the legal, social, and ethical implications of medical research. Mondale noted that unprecedented developments like heart transplants, artificial hearts, and greater understanding of the human genetic code held "great promise for the present and future of mankind," but at the same time raised "profound and complex questions of ethics, law, and public policy."¹¹ Philosophers and religious leaders were discussing the implications of organ transplantation, and physicians themselves were grappling with issues such as when it was justifiable to undertake a heart transplant. There were many legal issues to be worked out, Mondale noted, including how people could consent to donation, whether organs could be bought and sold, and the responsibilities and culpabilities of physicians and medical examiners. Commission recommendations could help American society deal with the implications of scientific advancements "in as rational and public a fashion as possible." Anticipating there might be resistance to the idea, Mondale said, "I think the medical professional has a right to ask us to give him the resources and the elbow room he needs to fulfill his function. But I think that same professional must understand that society has a stake in what he is doing, and that society must know not only what he is doing, but the implications of his efforts." Mondale hoped to persuade the medical profession "that they have far more to gain than lose in the responsible pursuit of this subject."¹²

Mondale's call for a commission fit into a trend in the 1960s in which medical authority was being more closely examined. The 1960s was a period in which all sorts of traditional authority (with regard to race relations, foreign policy, male dominance, politicians, police, parents, etc.) was questioned, and scientists and physicians were not exempt. News of a number of examples of unethical medical research on human subjects helped spur new procedures to ensure informed consent and more checks on research methods. Simultaneously, practitioners of the new field of bioethics argued that outsiders like philosophers, theologians, and even the general public could contribute helpful insights to the biomedical field. In addition, patients came to expect more information, rights, and participation in their health care, and sometimes these changed expectations contributed to pressures for government intervention.¹³ Not everyone in the medical field welcomed the perspective of outsiders, however, whether they were the public, ethicists, or politicians.

Hearings on Senator Mondale's proposed commission illustrated differences among transplant medical personnel about the federal government's role that would persist for three decades. A few prominent heart surgeons welcomed a government commission. Adrian Kantrowitz did so because his field faced some significant issues, including the scientific, philosophical and legal question: "What is death? At what point do we pronounce the donor dead and remove the heart?" He suggested that it would be helpful if local statutes were amended to redefine death in terms of irreversible brain damage. He also predicted that once transplantation techniques were perfected, there would be a shortage of organs, leaving another extremely difficult question: which of several dying patients should get the available organ and the chance to live? "I hardly need observe that we are not now organized to make such decisions," Kantrowitz said. "Government leadership will be needed."¹⁴ Stanford's Norm Shumway also welcomed governmental involvement. Indeed, he credited federal funding for the progress made in heart transplantation. Shumway thought a national commission would be beneficial, even if it included nonmedical people, since it would serve to educate members of Congress and the public. Shumway was angry that prominent cardiologists, who were ignorant of the results of experimental work, had denounced heart transplantation. He said their statement demonstrated that physicians, too, needed to be educated. In order to realize the full potential of a wondrous new era in medicine, Shumway said doctors would need help, and "much of the assistance will come from sources outside the medical profession." Once people learned more of the facts about transplantation, he felt certain they would be more likely to support the field. "Transplantation of the heart," observed the far-sighted Shumway, "fortunately or unfortunately, cannot be done without public notice and public support."¹⁵

Others were less supportive, however. Christiaan Barnard, who had studied in the United States, found the very concept of a commission insulting. The only possible reasons to propose such a commission, he told a Congressional subcommittee, were if one perceived problems with the procedures or if there were new issues posed by transplantation. He vigorously defended his heart transplants and denied there were any such new issues. Asked about potentially difficult ethical decisions about who should receive scarce organs, he said doctors should decide. Asked if society should consider a new definition of death, he said doctors did not need the help of a commission to tell them when a potential donor died. When one Senator noted that the public paid for the costs of transplantation and research, Barnard said it did not matter. Comparing surgery to a war, a combative Barnard declared that the public might pay the costs, but only "the general is qualified to make the decision."¹⁶ Minnesota's Owen Wangensteen told the subcommittee that the medical community already monitored itself through peer review committees. All innovative new procedures were subject to careful scrutiny, and there was no need for legislation or the input of theologians, lawyers, philosophers, or others. "I cannot see how they can help," said Wangensteen. He cited specific historical examples of government commissions that had opposed promising new medical procedures (like smallpox inoculations and anesthesia), and asserted that doctors should be trusted and medical innovators should not be "second-guessed by self-appointed arbiters more versed in the art of criticism than the subject under scrutiny."¹⁷ More than simply the government, then, it was the scrutiny of the public and "outsiders" that some in the medical community worried about. Even Henry Beecher, a Harvard anesthesiologist who supported a commission, observed, "[V]ery properly, the medical professional is fearful of outside control."¹⁸ Near the end of the hearings, Senator Mondale lamented "the strange gap that exists in communications between the medical profession and the community at large, and in some parts of the medical profession an almost inexplicable paranoia about opening up communications."¹⁹

Mondale did not get his wish for a commission in 1968, but as he predicted, legal and social problems arose, especially related to the status of organ donors. The Uniform Anatomical Gift Act (UAGA), crafted in 1968 by the National Conference of Commissioners of Uniform State Laws, solved some of the immediate issues. It recognized the right of an individual to donate his or her organs for use after death, spelled out who else (e.g. immediate family) might make the decision to donate, and designated to whom (e.g. transplant hospitals) organs could be given. To facilitate donation, soon many states had adopted a method by which anyone getting a driver's license could indicate the desire to be an organ donor in case of unexpected death. All fifty states eventually passed a fairly similar version of the UAGA by 1972.²⁰

There could be no transplantation without good donors, and surgeons knew that the ideal ones were otherwise healthy individuals who had suffered traumatic irreversible head injury and were maintained on artificial support. By the 1960s, respirators regularly were keeping the lungs breathing and hearts beating in many patients whose brains were fatally damaged even after there was no chance of existence off of the respirator. However, because common law and common sense decreed that a person had died when he or she stopped breathing and the heart stopped beating, it would require a major change in perspective to recognize that these fatally brain-injured patients actually were deceased.²¹ In 1968 in an article in the Journal of the American Medical Association (JAMA), a prestigious Harvard committee recommended adopting a new "brain death" standard for determining the moment of death. The Harvard committee stated that the characteristics of a permanently nonfunctioning brain included unreceptivity and unresponsiveness, no movements or spontaneous breathing, and no reflexes. It suggested that tests for these criteria should be repeated over the course of twenty-four hours, and said that a flat EEG would be of great confirmatory value.²² The Harvard committee declared that speedy acceptance of this standard would help the families of brain-dead patients understand what was happening, assist hospitals and patients who needed intensive care beds currently occupied by brain dead patients, and insure that there would be no controversy in obtaining organs for transplantation.²³ Relieved, the transplant medical community quickly moved forward to using brain dead donors.

Despite compelling reasons unrelated to organ transplantation for seeking clarity on the issue, however, some ethicists and members of the public were concerned that the very meaning of death was being altered partly because of a desire for organs.²⁴ "I have a horrible vision of ghouls hovering over an accident victim with long knives unsheathed, waiting to take out his organs as soon as he is pronounced dead," said one man.²⁵ Popular culture suggested that some mistrusted the motives of transplant surgeons, who were viewed as "vultures, waiting for a convenient death to bring life to their patients."²⁶ Indeed, Robin Cook's best-selling 1977 novel Coma, which was later made into a popular movie, portrayed a corrupt underground where physicians caused brain death in patients in order to sell their organs. The director of a pediatric lung transplant program declared, "Coma probably set transplantation back five years!"²⁷

If the Harvard Commission's pronouncement did not assuage public concerns regarding brain death, neither did it take care of legal issues. In a prominent court case, transplant surgeons at the Medical College of Virginia were sued for the wrongful death of a brain dead man whose heart and kidneys were donated after doctors had turned the ventilator off. Surgeon Richard Lower was acquitted, but the outcome had been far from certain, and in the years while the case languished in the legal system, he was unable to perform organ transplants.²⁸ In California, heart surgeon Norman Shumway clashed with his county coroner over use of cadaver organs for transplant, and uncertainty about the legal definition of death had "scared hell out of doctors" who feared lawsuits.²⁹ Some states passed a law recognizing brain death, but others did not, and even the versions they passed differed, resulting in the bizarre circumstance that a person could be considered dead in one state but not another. Confusion reigned for over a decade.³⁰ It required a national Presidential Commission formed in 1980 to bring together medical and other experts to recommend the use of brain death criteria and craft a uniform law that was quickly adopted by the American Medical Association, American Bar Association, and the states.³¹ It's clear that both implementation and acceptance of brain death criteria took longer than the eager transplant community wanted, and the involvement of the federal government facilitated the cause.

With the introduction of cyclosporine as an immunosuppressant drug, organ transplantation took off in the early 1980s, and politicization soon followed. When the media and President Ronald Reagan aired pleas for organ donation to benefit some desperate children waiting for transplants, it called attention to problems in the nation's procedures. In a very fragmented system, not enough organs were procured, and at the same time many organs were being wasted. People worried that those with money or connections had a better chance at getting a transplant, and a physician had even started a business to broker kidneys. In response to these concerns, Congressional Representative Al Gore proposed path-breaking new legislation in which the federal government would support and contract with a nonprofit organization to coordinate an efficient national transplantation network.³² Besides wanting to ban commercialism, Gore hoped legislation could "insure equitable and timely access" to the lifesaving procedures. Gore noted that before the federal government had gotten involved in kidney dialysis and transplantation, the recipients had been predominantly young, white, college-educated males, and afterwards, they were far more representative of those who had kidney disease. Gore said the federal government, which was already paying for most of the nation's organ procurement through its End Stage Renal Disease Program, should act. "I believe only the Federal Government can best provide the glue and the conscience from which a national system can be formed."³³

At first there was some uncertainty among the transplant medical community over the proposed National Organ Transplant Act (NOTA). For example, surgeon Thomas Starzl initially felt skeptical, since he'd been displeased with federal bureaucrats who had decreed liver transplants "experimental" and ineligible for Medicare coverage. "I don't for a moment want to leave the impression that I trust the Government," he declared to a House subcommittee.³⁴ Ironically, though, the heaviest opposition to NOTA came from within the Reagan administration, which in general favored smaller federal government. Reagan's Surgeon General and his appointees in the Department of Health and Human Services (HHS) argued that control over organ transplantation should remain solely in the private sector.³⁵ The Surgeon General quickly helped start a private organization, the American Council on Transplantation (ACT), which was a consortium of individuals and organizations that he hoped could handle the issues and thereby avoid government involvement. However, even the surgeon who was interim president of ACT said there should be some kind of "strong federal statement" regarding organ transplantation and "a well-defined and visible focus within the Federal Government, presumably within DHHS, to interface with groups such as ACT, to share concerns and more importantly, solutions."³⁶ The divided membership of the hastily assembled ACT decided not to take a formal position on the proposed legislation.

Eventually most of the transplant community, including organizations representing surgeons, physicians, coordinators, and patients, came to advocate for the National Organ Transplant Act. Even the initially skeptical Starzl concluded, "[I]t is a very fine bill and I hope it passes. I think it would do wonderful things for health care in this country." Starzl decided it would make multi-organ procurement easier. "The procurement agencies cannot be little cottage industries devoted only to the kidney transplant programs," he asserted. "There is only one set of donors for all the needed organs and the organs are a resource of the entire United States. This concept has to be built into the system." The national network, agreed a kidney surgeon, was "an outstanding idea and one whose time has finally come."³⁷ Others wanted the government to outlaw the sale of organs and oversee the collection of transplant data. At Congressional hearings in 1984, Representative Henson Moore pointed out to a panel of surgeons that the bill empowered federal bureaucrats. "If you are giving them power," he warned, "you are giving yourself problems."³⁸ But Starzl and his colleagues replied that they were not worried, because the government already subsidized and influenced almost all the nation's organ procurement and transplantation without interfering in a problematic way.³⁹ They were swayed by the many benefits the government seemed to be offering, including the possibility of recognition that heart and liver transplants were no longer "experimental," Medicare coverage for some immunosuppressant drugs, better computers and public and professional education, and support for national coordination. They hoped that since the government would contract with a private nonprofit organization to run the network, they as surgeons would continue to make decisions about allocation policies. Oscar Salvatierra, president of the American Society of Transplant Surgeons (and also a member of ACT), said "[t]he issues facing transplantation today are of a more critical nature and require more urgent action than this type of loose federation [in ACT] could ever conceivably give. ... [T]hese latter problems would best be solved by congressional action like H.R. 4080 proposes." Salvatierra concluded the legislation could result in a "more effective public/private partnership."⁴⁰

The National Organ Transplant Act passed easily with bipartisan support in 1984.⁴¹ It outlawed profit from the purchase of solid organs, insuring that organ transplantation would continue to rely on voluntary donation of the public and not become a commercial venture within the United States. It also decreed that the Secretary of Health and Human Services should contract with a nonprofit Organ Procurement and Transplantation Network (OPTN) that would, among other things, establish a national system to list individuals who needed transplants and match them with available organs. It established an administrative unit within the federal bureaucracy to submit annual reports to Congress about the effectiveness of the system. In addition, it created a national task force to consider medical, legal, ethical, economic, and social issues related to organ transplantation.⁴²

The resulting twenty-five-member national task force greatly influenced the subsequent direction of organ transplantation in the United States. The secretary of HHS appointed Olga Jonasson, professor of surgery at the University of Illinois, to chair the committee, which was composed of nine physicians or scientists in specialties related to transplantation; three nonphysicians in fields of procurement; four nonphysicians with expertise in law, theology, ethics, or health care financing; three members of the general public; two health insurance representatives; and four ex-officio members from NIH, FDA, HCFA, and the Surgeon General's office. The task force commissioned studies, did literature reviews, and held public hearings. In the fall of 1985 the committee submitted its report.⁴³

The committee's key recommendation was for a single national system for organ sharing with mandatory and uniform policies and standards. In addition to medical professionals, governance of that system should include groups representing patient, community, and ethical perspectives. The task force said the public deserved input not only because decisions about how to allocate organs were difficult, but because of the "special nature" of organ transplantation. Transplantation was unlike most medical procedures because it relied on a very scarce resource: an organ voluntarily donated by another human being. Other medical resources (such as drugs or expensive technology) might be scarce, but usually more money could obtain them. Organs were different in the U.S. system; money could not and should not obtain more of them. The only way to increase the supply was through persuading the public that their generosity was for a worthwhile cause. And "[c]ontinued public support for organ transplantation," it stated, "depends on public confidence that organs are distributed equitably to those who need them."⁴⁴ Selection of patients for transplant should not be subject to favoritism or discrimination on the basis of nonmedical factors, such as race or sex, or ability to pay.

The task force asserted, just as Thomas Starzl had, that "each donated organ [should] be considered a national resource to be used for the public good." The corollary, though, was that "the public must participate in the decisions of how this resource can be used to best serve the public interest."⁴⁵ While the public was to serve as trustee of donated organs, the task force recommended important duties for the federal government in implementing that role, including that HHS establish minimum criteria for and certify organ procurement organizations and transplant centers, and that Congress spur collection of transplant data and make transplants available to all by funding coverage of them and the necessary immunosuppressant drugs. It also recommended various strategies for increasing organ donation, including a law requiring hospitals to provide the opportunity for organ donation to suitable families. Over the next few years, Congress enacted many of the national commission's recommendations, giving (in somewhat vague terms) oversight responsibility to the Department of Health and Human Services.⁴⁶

The United Network for Organ Sharing (UNOS) was chosen by HHS to serve as the nation's organ procurement and transplantation network, and UNOS accepted responsibility for establishing criteria for the listing of patients for transplantation, maintaining the waiting list, and operating an equitable system for matching and allocating donated organs. Hospitals that performed transplants, organ procurement agencies, and tissue typing labs were required to be members of UNOS; some institutions like nonprofit professional and health organizations were members as well.⁴⁷ All UNOS policies had to be approved by the board of directors after consideration by committees. The makeup of this board was contested. At first, HHS declined to award UNOS the contract because its board was not as representative as the national task force had recommended—suggesting some lingering reluctance to allow people other than surgeons a voice in organ transplantation—but UNOS resubmitted a more acceptable proposal.⁴⁸ Over time, the membership of the board of directors has evolved so that it now includes approximately 50 percent transplant surgeons and physicians; at least 25 percent transplant candidates, recipients, donors, or their families; and the rest representatives of other interested groups, including coordinators, organ procurement operations, labs, non-profit health groups, and the general public.⁴⁹

After awarding the contract for the national network, the government's executive branch was not very active. In the first few years of its existence, UNOS developed an increasingly responsive and efficient system.⁵⁰ Its policies for the allocation of organs, however, were contested and sometimes resisted by its member transplant centers and surgeons who were accustomed to making their own decisions about how best to distribute organs retrieved locally. These life and death decisions were not easy, especially given loyalty to one's own patients. How would it be determined which hospital in an area received an organ that became available? Should the procuring hospital get priority? Or was it fairer for hospitals in the same region to take turns? How big should a "region" be? And what about individual patients? Doctors agreed on some basic medical criteria for matching patient and donor organ size and blood type, but after those were met, should the patients who had waited longest get first priority for organs? The ones closest to death? The youngest? The most "worthy" in some way? Despite Congress' desire for consistency in the policies, many transplant centers insisted on being allowed to develop their own policies, which UNOS permitted. "At the outset, the exceptions were invited to swallow up the rule," observed analyst Jeffrey Prottas.⁵¹ All of UNOS' policies were voluntary, and would not have the power of law until HHS issued formal regulations. Because the Reagan administration wanted the federal government to stay out of transplantation, it never issued regulations and consistently undermined Congressional intent regarding transplantation, which infuriated the National Organ Transplant Act's early sponsors. Representative John Dingell denounced the "insurmountable inertia in HHS" and the fact that organ procurement organizations were "not accountable to anyone."⁵²

By 1993, many in the transplant community wanted the government to issue regulations, and let the new Clinton Administration know it. At hearings on reauthorization of legislation, patient advocacy groups complained in Congressional hearings about the variances from one region of the country to another. A Pittsburgh surgeon criticized UNOS for changing its liver allocation rules in a way that had "enormous and devastating impact" without any appreciable public comment or HHS approval.⁵³ While Randal Bollinger, the president of UNOS, worried about whether federal rule-making could adjust to the rapid changes in transplantation, he too lamented the fact that in the absence of HHS action UNOS did not have the ability to enforce its policies. He acknowledged HHS' "ultimate authority," but hoped the federal government would mandate some broad parameters of principles and let UNOS handle the details of procurement and allocation.⁵⁴

Like its predecessors, the Clinton Administration moved slowly, until transplantation politics heated up in 1996. Complaints about recent changes in UNOS' liver allocation policies prompted HHS to hold three days of hearings to make sense of serious disagreements within the transplant community. Surgeons contended that some of their colleagues stretched the truth to push their patients up the waiting list. Some accused UNOS of ignoring up-to-date data, discriminating against people with chronic liver disease, and putting the needs of inefficient transplant centers above those of patients. Counter accusations implied that those transplant centers who did not benefit from UNOS policies were sore losers who appealed to the federal government to overturn the policies.⁵⁵ All contended that more people would die under their opponents' policies. UNOS tried to prevent HHS from holdings hearings at all.⁵⁶

After years of study and consideration of hundreds of comments, in March 1998 the Department of Health and Human Services finally issued regulations. HHS Secretary Donna Shalala said the "final rule," as such federal regulations are called, was intended to remedy inequities in the current system. One inequity was that patients in one part of the country were waiting as much as five times as long for an organ as those in others, a disparity apparently caused by the practice in which organs were first offered to all patients in a narrowly defined local area before being shared more widely with those who needed them more desperately. Accidents of geography should not determine whether a patient lived or died, said Secretary Shalala. Nor should the wealthy be able to travel somewhere with a shorter list. "Instead, patients everywhere in the country should have an equal chance to receive an organ, based on their medical condition."⁵⁷ While not specifying a particular method of organ allocation, the final rule required that the nation's network (UNOS) develop a policy using medical urgency, not geography, as the main criterion for allocating organs. The regulations also asserted that every transplant center should use the same medical criteria for placing patients on the list. "There is a central purpose to the performance goals," stated Shalala, "which is to ensure, to the maximum possible extent, that all patients, regardless of where they live, are treated the same."⁵⁸ The final rule included a sixty-day comment period, and was scheduled to take effect after ninety days.

The regulations alarmed some in the transplant community. The influential transplant center in Pittsburgh, however, which had been pushing UNOS for a liver allocation policy that gave priority to the most urgent patients all over the country, applauded the final rule. Joining its doctors were other transplant centers and a number of patient advocacy groups. But other patients, surgeons, and hospitals had reservations.⁵⁹ Some interpreted the final rule as saying that organs had to go to the very sickest patients first, which, since the very sickest might not survive a transplant as well, would not be the wisest use of resources.⁶⁰ Some worried HHS was mandating a single nation-wide waiting list, and like the patient testifying who said she feared "organs flying and patients dying," believed it was impractical to transport organs all over the country.⁶¹ Some asserted that it was unfair (and unwise) for communities that were good at soliciting organ donation to lose the organs donated locally. "We urge you not to punish States for their successes and to reward others for their failures," said a letter to Shalala, and consequently some states considered laws to prevent organs from leaving their state.⁶² The biggest concern for some opponents, though, was that the new regulations might put smaller transplant centers out of business, since they would be forced to share organs with urban areas with more needy patients. Economics mattered. "This is about the financial life and death of transplant centers around the country," asserted Representative Thomas Barrett.⁶³ While smaller centers accused larger ones of trying to prevent competition that cut into their market share, larger ones accused smaller ones of inefficiency and the hoarding of organs.⁶⁴

Shalala tried to reassure the regulation's opponents. "We know that transplanting the sickest patient is not always the best course," Shalala explained. "We believe that transplants should be performed on the basis of medical urgency, the definition of which includes viability and chances of survival. Further, it is up to UNOS to develop policies on medical urgency." HHS also clarified that it was not requiring a single national waiting list. The best system might prove to be national or regional lists, but again, HHS left it up to the medical experts in UNOS to develop a system that promoted more sharing and equity in a practical manner. "The rule calls for fairness. How fairness is achieved in terms of allocation policy is primarily up to UNOS... . Any policy that is sensible, is based on sound medical judgment, and reduces geographic inequity, will be taken seriously by the Department." Though Shalala did not see how the regulation might force some transplant centers to close, she was willing to add something to the regulation to monitor its impact on different-sized centers. She recognized that there were concerns that organs would leave areas that had worked hard to get organs, but said the entire transplant community needed to come together to address the organ shortage. Citing the AMA's code of medical ethics, she noted, "Organs should be considered a national, rather than a local or regional resource."⁶⁵

UNOS opted to fight the regulations and HHS with no holds barred. The organization paid a firm over $1 million to conduct a public relations campaign and lobby Congress to block the regulations. UNOS warned its members about the worst possible outcomes of the new rules and said unqualified bureaucrats in HHS were wresting control over medical decisions from the appropriate medical professionals. UNOS created a "legislative kit" for members that included sample form letters to Congress. It was certainly unusual for a federal contractor to publicly lobby against the federal agency charged with overseeing it. The staff at HHS, an agency that had oversight over many health areas and other federal contractors, could not believe how difficult UNOS was to work with. On one occasion, UNOS defied HHS by denying its request for data—data which HHS thought would have further bolstered its position.⁶⁶ HHS staffers were dismayed. "To have UNOS do such a blanket smear campaign just has been extremely frustrating," said HHS' Claude Earl Fox. Secretary Shalala agreed, telling Congress, "I have been very critical of UNOS. I have never dealt with a contractor quite in this way. I want this relationship to move into a collegial stage. We need to do that for the American people."⁶⁷

Yet according to observers, the conflict was "adversarial," "polarized," "fierce," and "nasty."⁶⁸ Opponents of the regulation said HHS was simply "not qualified" and suggested its policies were crafted in response to improper influence from a longtime friend of Bill Clinton. "Where does all this [government interest] come from?" asked UNOS' Walter Graham. "The only answer I can come up with is that it came as a result of political influence."⁶⁹ They characterized HHS as making a dictatorial federal power grab.⁷⁰ As mentioned earlier, liver surgeon Anthony D'Alessandro complained that "Miss Shalala is determined to anoint herself federal organ transplant czar," and "political appointees" would make the final decisions about who lived and who died that previously had been reached by consensus among transplant doctors.⁷¹ Both sides accused the other of putting self-interest above patient care and of having "politicized" the disagreement in an unseemly manner.⁷² Supporters of the regulations fought back by questioning whether UNOS' policy-making processes were fair and the organization representative. "Where's the public accountability?" asked patient advocate Charles Fiske. "It's a private little club."⁷³ Congressman John Dingell went further, characterizing UNOS as "a shoddy, shabby contractor who seeks an absolute monopoly over the handling of organs in this nation" and which perpetuated "deceit, misrepresentation and falsehood."⁷⁴ In an unusual turn of events, the battle lines in Congress were not drawn over political ideology; indeed, some conservative Republicans and liberal Democrats found themselves on the same side.⁷⁵ Nor was it the transplant community against the government. The transplant community itself was deeply divided—along the lines of urban versus rural centers, larger centers versus small, or advocates for the acutely ill versus the chronically ill. The disagreements that they fought over inside UNOS and inside their professional organizations had simply been transferred to the political realm. Senator Bill Frist, who had been a transplant surgeon before being elected to national office, reported, "When you go into board meetings at UNOS and the regional meetings, there are more politics there than there are here [in Congress]."⁷⁶

While the battle focused mainly on the implications of the regulations with regard to organ allocation, a crucial subtheme was the appropriate role of the federal government. Whether because of legitimate differences over policy, defensiveness over criticism of their work, or fear of losing the independence the organization had enjoyed during previous presidential administrations, UNOS leaders wanted little to do with HHS. "UNOS is not an agent of the government," asserted executive director Walter Graham, and on a number of occasions, some UNOS presidents had suggested HHS had no authority to shape policy on allocation.⁷⁷ When questioned before Congress, UNOS President Larry Hunsicker was more moderate, claiming UNOS "certainly [did] not object to the Federal Government's appropriate oversight role."⁷⁸ Still, he interpreted the fact that the National Organ Transplant Act made the nation's organ network a private organization to mean that the government "should be shielded from direct involvement in sensitive medical and ethical issues." When asked how he envisioned the appropriate relationship with HHS, Hunsicker said it should be a partnership, "with the lead being taken in terms of developing policies by the community that is being governed by them." Interestingly, this was quite similar to what was being proposed by HHS in the final rule. Yet in the next breath Hunsicker also said that the relationship UNOS had had with HHS for the previous twelve years (during which HHS rarely intervened) was "an appropriate way to do things."⁷⁹ To UNOS leaders, "appropriate oversight" appeared to mean no oversight. Of course not everyone in the transplant community shared the official position of UNOS; after all, it had been some patient groups and disaffected transplant centers who had appealed to HHS in the first place to arbitrate, and many testified at hearings in 1998 and wrote comments in support of the regulations.

Although Shalala met with many groups and modified aspects of the regulations, she and her HHS colleagues would not budge from their main direction nor cede authority. She asserted that the National Organ Transplant Act gave HHS the responsibility to oversee the network—and had done so precisely because there had been inconsistency, inefficiency, and abuses in the nation's transplant system. Subsequent laws reinforced the requirement that transplants paid for by the government had to comply with criteria issued by HHS, and the federal government paid for well over half the transplants in the country. "To say we have no basis to issue regulations when our authority is clear," she asserted, "is a disservice to Congress, which created the network, and to the patients, whose transplant bills are paid by taxpayers."⁸⁰ HHS' Claude Fox pointed out that UNOS received many benefits from the government, including the right to operate as a monopoly, and as a result had to accept controls. "We answer to Congress," he said bluntly, "and they answer to us."⁸¹ Shalala seemed especially frustrated because her staff had specifically allowed UNOS to retain primary responsibility over the particulars of the allocation rules. HHS had intentionally not crafted detailed, heavy-handed regulations as it had done for other issues. "We are trying to strike a balance here," she stated, "a balance between the responsibility that we have for oversight of a very sensitive issue and the very important role of the medical professionals in providing for the system."⁸²

Characterized by shrewd maneuvers and counter-moves, the regulation controversy continued for two years. Opponents of the regulations won an early round by bypassing HHS and taking their case to Congress. In October 1998, Congress passed a measure that delayed the regulations for a year, required UNOS to provide certain data, and commissioned a study by the more neutral Institute of Medicine.⁸³ HHS won a round when the Institute's report largely endorsed the direction of the regulations, concluding the system was "not functioning as well as it could" and recommending that HHS "exercise the legitimate oversight responsibilities assigned to it."⁸⁴ As the end of the year approached, regulation opponents successfully added a rider with another ninety-day delay to an unrelated bill that was approved by Congress.⁸⁵ Meanwhile, they introduced a new bill that would have created a long-term solution, nullifying the final rule, lessening HHS power, and effectively giving UNOS a permanent position as the nation's organ transplant network.⁸⁶ The House of Representatives passed this bill. Supporters of the regulations called the bill "outrageous," threatened a presidential veto, and worked with Senator Bill Frist on an alternative. Frist crafted a middle-of-the-road bill with the goal of having "medical decisions made by the transplant community, with strong oversight and strong accountability." Reaching a compromise on the different Senate and House bills was difficult; according to Senator Ted Kennedy, it was like trying to "cross a Chihuahua with a Great Dane."⁸⁷ When compromise proved impossible, the final result was that Congress passed no new transplant legislation. This meant that the HHS regulations took effect on 16 March 2000. HHS solidified its victory by putting compliance with the regulations in the new UNOS contract.⁸⁸

Though the bruising battle over HHS regulations took a toll, it resulted in positive outcomes. UNOS suffered blows to its reputation, and more significantly, the intense dispute over the regulations had exposed divisions and irritated wounds in the transplant community.⁸⁹ However, issuance of the federal regulations gave UNOS the authority it wanted and needed to make its policies mandatory rather than voluntary, which all parties had agreed was necessary. The regulations declared that the criteria for listing and prioritizing patients on the waiting list must be consistent everywhere in the nation and based on medical factors. As required, UNOS then developed policies that were far more complex and objective. Based on algorithms related to medical urgency and likelihood of survival on the waiting list, the new policies decreased the number of patients who died while waiting for transplant while still maintaining a very high level of success. UNOS leaders agreed it was an improvement.⁹⁰ More effective and more just (by eliminating the wiggle room in the old system), the new policies increased trust in the system. "Blood tests don't lie," noted one surgeon.⁹¹ Outside pressure from HHS, then, forced UNOS to transcend the competing claims and squabbles that had hampered the organization. Moreover, HHS managed to spur these positive changes while still leaving development of the specific allocation policies in the hands of the medical professionals (along with representatives of patients and donors) in UNOS. Thus the fears expressed by D'Alessandro did not come to fruition. HHS merely set parameters to insure greater fairness and achieved that without "taking over" organ transplantation. Ironically, despite the complaints, the federal government's interference ultimately led to more consistency, legitimacy, and strength for UNOS.

Looking back, it is clear that in the three key periods of politicization of organ transplants in 1968, the mid-1980s, and the late 1990s, some in the U.S. transplant medical community had resisted while others had welcomed the involvement of the federal government. It is natural for any profession to want to develop and enforce its own ethics and standards, so not surprisingly, some surgeons in particular fiercely defended their area of expertise. Others simply saw no need for outside assistance or opposed the specific HHS regulations. In contrast, others eagerly embraced the benefits that accrued from government assistance, such as legal clarification of donor status, grants to subsidize organ procurement, Medicare/Medicaid coverage of transplant surgeries and immunosuppressant drugs, standards for organ procurement agencies, and establishment of a national organ transplant network. In the 1990s, others simply agreed with the content of HHS regulations. Some pondered the transplant community's partnership with the government and thought it made sense. Despite warnings from the Reagan administration and questioning from Congress, however, not everyone who supported the laws of the mid-1980s appreciated the wider implications of government support. They did not always consider that oversight accompanied the benefits or what "oversight" might involve. "Miss Shalala's department has oversight responsibility for this process," acknowledged surgeon D'Alessandro, "but no one ever dreamed that HHS would ever seek to exercise direct policy-making authority."⁹²

Despite disagreement over it, the federal government's involvement in organ transplantation made sense. Unlike most medical treatments, public support and outside help were crucial. There could be no transplantation without the gift of scarce organs by the general public, and history proved that public support was not automatic. The early heart surgeries suggested that if the profession did not monitor itself, there could be fallout. Years after the heart transplant craze in 1967–68, surgeons admitted that too many of them had performed heart transplants and done so for the wrong reasons. "People were performing transplants who had no idea what they were doing," declared Norm Shumway. "It wrecked the field for a good five years."⁹³ Indeed, kidney transplant pioneer Joseph E. Murray referred to the period from 1968 to 1970 as "transplantation's darkest hour."⁹⁴ Public scrutiny, though, caused heart transplant leaders to take a hard look at their practices, set strict criteria for future transplants, and communicate more clearly with the public, which was best for all concerned.⁹⁵ The issue of brain death also illustrated the necessity of achieving public understanding as well as a legal infrastructure for the procurement of donor organs. On issues like recognition of brain death criteria and the outlawing of profit from organs, it made sense for there to be national policies rather than state-by-state variations. In addition, because organ transplantation relies upon quick matching and transportation of organs to the appropriate people, it is crucial for there to be cooperation, communication, and sharing between hospitals and across state lines. A fragmented and competitive system did not serve patients well, and in the mid-1980s it became clear that national coordination was essential to achieving both efficiency and fairness. Again the government seemed to be the logical party to spur such coordination, which it did in the National Organ Transplant Act. Transplant surgeons recognized that Congress had not only improved public awareness of and access to transplantation, but its legislation had served as an "extremely important catalyst in bringing together the relevant interests to move transplantation forward."⁹⁶

Not surprisingly, the allocation of organs had become especially politicized. Different plans necessarily benefit different patients, such as the chronically ill, the most acutely ill, those with particular diseases, or those in different locations. Reasonable, caring, and dedicated people could differ over how to resolve the medical and ethical dilemmas caused by the organ shortage, and the stakes were high. "A lot of things we do involve peoples' lives," said an HHS official, "but changing the system of distributing organs alters who lives and who dies, or how long you live and when you die."⁹⁷ "[R]eally the wisdom of Solomon is called for here," agreed one Congressman.⁹⁸ Achieving the elusive goal of equity required not just quality data and medical expertise, but vision, commitment to a fair process, the desire to build consensus, civility, and a special sensitivity, all of which disappeared at times during the battle. Surgeons and transplant centers fought hard to save their patients, as they should have, but also displayed concern for their self-interest, power, or profits. Even worries about losing their "fair share" of organs suggested a sense of ownership and an assumption that organs belonged to a certain group of people or a particular locale. In the face of established interests, UNOS had difficulty building consensus on allocation policies.⁹⁹ In appeasing the forces who wanted to keep allocation decisions local, UNOS lost sight of the sentiment expressed in the national task force's report that organs are a national resource to be carefully nurtured. HHS appropriately stepped in and provided the national perspective that had been missing, and acted—with moderation—to insure fairness for patients all over the country.

The federal government, subject as it is to political pressures, cannot necessarily be counted on to be an efficient overseer or an objective arbiter; neither, however, should it be assumed to be a dangerous or dictatorial intruder. So far in the case of organ transplantation it has tended to be a helpful trustee. It helped provide a legal basis for obtaining organs from brain-dead donors and has taken other actions supporting organ donation. By funding organ procurement and transplants, it provided legitimacy for new procedures that influenced private insurers and made it possible for thousands of patients to receive a second chance at life. It pushed the field to become nationally coordinated faster than it could have without external assistance, which meant more efficiency and the saving of more lives. It pushed UNOS, transplant centers, and organ procurement organizations to be more accountable, share data that empowers patients, be more self-conscious about the medical and ethical bases for its decisions, and listen to voices other than those of surgeons.¹⁰⁰ HHS regulations resulted in greater equity and increased trust in the allocation system, and did so while still insuring that the medical experts and affected parties crafted the specific rules by which they must abide. The transplant medical community now assumes that the public has a legitimate and important role in organ transplantation.¹⁰¹

From the failed early heart transplants, the establishment of brain death criteria, benefits from legislation in the mid-1980s, and controversy over organ allocation, the transplant medical community appears to have learned that the federal government has the potential to be a helpful partner. After the nasty battle of the late 1990s firmly established the government's oversight, transplanters seem to have moved on and are working toward a productive relationship. Indeed, recently leaders in the American Society of Transplant Surgeons said they had "played a major role" in guiding the development of new federal regulations for transplant centers being considered in 2008. Though still not entirely pleased with those regulations, they characterized their work with the federal bureaucracy as "fruitful dialogue" and said the government, transplant caregivers, and patients were "all on the same page." UNOS' website declares that before policy proposals are submitted to HHS for review, "public input ... is an essential part of the policy development process."¹⁰² Long gone are the days when transplant surgeons could arrogantly assert their expertise and expect the public would not question them. Today's transplant practitioners would probably agree that Norm Shumway was right when he said, "[F]ortunately or unfortunately, [transplantation] cannot be done without public notice and public support," and that Senator Mondale was prescient when he said in 1968, "Those who really believe in advancing medical knowledge have far more to gain from public understanding than public ignorance."¹⁰³

	NOTES

TOP ABSTRACT NOTES

 
Funding: Elon University sabbatical support.

¹ Anthony M. D'Alessandro, "Hostile Organ Takeover; Donna Shalala, Organ Donor Czar," Washington Times, 16 March 2000, A21.

² In this article, the term "transplant medical community," refers especially to surgeons who transplanted various solid organs, who were the leaders and most vocal members of this community, but also includes transplant physicians, coordinators (who are often nurses), and various other medical personnel involved in the surgery and treatment of transplant patients and the procurement of organs, and UNOS staff. The more general term "transplant community" includes the medical practitioners as well as patients and their loved ones, donors and donor families, and other interested parties like ethicists, lawyers, etc.

³ Donald McRae, Every Second Counts (New York: G. P. Putnam's Sons, 2006), 146–154, 166, 208.

⁴ Jürgen Thorwald, The Patients (New York: Harcourt Brace Jovanovich, 1972), 269, 287–8.

⁵ Anon., "Saving New Hearts," Newsweek, 7 January 1980, 39.

⁶ Anon., "The Hasty Hearts?" Newsweek, 22 January 1968, 60; Anon., "Transplants: Guarded Outlook," Newsweek, 21 July 1969, 109; Anon., "Heart-Transplant Revival," Newsweek, 1 November 1976, 12, Thorwald, The Patients, 284, 287, 320; Tony Stark, Knife to the Heart (London: Macmillan, 1996), 93.

⁷ Anon., "Surgical Show Biz," The Nation, 22 January 1968, 100.

⁸ Edwin Diamond, "Are We Ready to Leave Our Bodies to the Next Generation?" New York Times, 21 April 1968, SM 26; Anon., "The State of Many Arts," Science News, 2 March 1968, 233.

⁹ Anon., "A Plea for a Transplant Moratorium," Science News, 16 March 1968, 256. This "quasimoratorium" continued until the early 1980s, when cyclosporine was approved as an immunosuppressive drug. Renée C. Fox and Judith P. Swazey, The Courage to Fail: A Social View of Organ Transplants and Dialysis (Chicago: University of Chicago Press, 1974), 123–148; Renée C. Fox and Judith Swazey, Spare Parts: Organ Replacement in American Society (New York: Oxford University Press, 1992), 7.

¹⁰ Anon., "Reassessing Transplants," Newsweek, 1 September 1969, 73; Anon., "Heart Surgery: Were Transplants Premature?" Time, 15 March 1968, 66; Anon., "Transplant Slump," Newsweek, 17 May 1971, 69; Anon., "Hasty Hearts?"; Fox and Swazey, The Courage to Fail, 140, 146.

¹¹ Walter Mondale, Introduction of Joint Resolution to Establish a Commission on Health Science and Society, Congressional Record, 8 February 1968, included as an appendix in National Commission on Health Science and Society, Hearings before the Subcommittee on Government Research of the Committee on Government Operations, United States Senate, 90th Congress, 2nd session, on S. J. Res. 145, 7, 8, 21, 22, 27, 28 March and 2 April 1968, 445–451. Mondale quotation on p. 445.

¹² Comments by Walter Mondale, National Commission on Health Science and Society, 6.

¹³ Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), 140–4; Fox and Swazey, Spare Parts, 23–4; Paul Starr, The Social Transformation of American Medicine (New York: Basic Books, 1982), 389–93; Anita Guerrini, Experimenting with Humans and Animals: From Galen to Animal Rights (Baltimore, MD: Johns Hopkins University Press, 2003), 137–141; Jonathan B. Imber, Trusting Doctors: The Decline of Moral Authority in American Medicine (Princeton, NJ: Princeton University Press, 2008), 107–9.

¹⁴ Adrian Kantrowitz testimony, National Commission on Health Science and Society, 30–38, 30.

¹⁵ Norman Shumway testimony, National Commission on Health Science and Society, 146–9, 149.

¹⁶ Christiaan Barnard testimony, National Commission on Health Science and Society, 77–86, 82.

¹⁷ Owen Wangensteen testimony, National Commission on Health Science and Society, 89–102, 100, and 98.

¹⁸ Henry Beecher testimony, National Commission on Health Science and Society, 117.

¹⁹ Comments by Walter Mondale, National Commission on Health Science and Society, 326.

²⁰ Sam Crowe and Eric Cohen, "Organ Transplantation Policies and Policy Reforms," staff discussion paper, President's Council on Bioethics, http://www.bioethics.gov/background/organ_donation.html, accessed 29 October 2008; R. Randal Bollinger, "The Role of UNOS in Thoracic Organ Transplantation," in Thoracic Transplantation, ed. Sara J. Shumway and Norman Shumway (Cambridge, MA: Blackwell Science, 1995), 141–48; Jeffrey Prottas, The Most Useful Gift: Altruism and the Public Policy of Organ Transplants (San Francisco, CA: Jossey-Bass, 1994), 12.

²¹ Prottas, The Most Useful Gift, 235; Anon., "Heart Operation Key Issue in Trial," New York Times, 29 October 1973, 5.

²² Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death, "A Definition of Irreversible Coma," J. Am. Med. Assoc., 1968, 205, 337–340; Robert Reinhold, "Harvard Panel Asks Definition of Death Be Based on Brain," New York Times, 5 August 1968, 1.

²³ Margaret Lock, Twice Dead: Organ Transplants and the Reinvention of Death (Berkeley: University of California Press, 2002), 89; Robert M. Veatch, Transplantation Ethics (Washington, DC: Georgetown University Press, 2000), 58; Reinhold, "Harvard Panel."

²⁴ The procedures for stating death has occurred, said ethicist Paul Ramsey, should not be "distorted by any reference to someone else's need for organs." Quoted in Jonsen, The Birth of Bioethics, 242. Reasons unrelated to organ transplantation were cited in President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Defining Death: A Report on the Medical, Legal and Ethical Issues in the Determination of Death (Washington, DC: The Commission, 1981), 10, 18–20, 24.

²⁵ Quoted in Lock, Twice Dead, 96–97.

²⁶ Quoted in Craig McInnes, "The Beat Goes on," The Globe and Mail, 28 November 1987, D1. Others mentioned that the evocative labels "vulture" and "vampire" were used to describe transplant surgeons. Roy Calne, A Gift of Life (New York: Basic Books, 1970), 78; McRae, Every Second Counts, 209. Some transplant surgeons seemed callous regarding donor rights. See Raymond Hoffenberg, "Christiaan Barnard: His First Transplants and Their Impact on Concepts of Death," Brit. Med. J., 2001, 323, 1478–80, and Lock, Twice Dead, 87–88. Others, though, were very concerned about absolute certainty that donors were dead and the need for public understanding. See, for example, discussion at a Ciba-sponsored international conference in 1966, and the Second International Congress of the Transplant Society where it was clear that even transplant surgeons had to get used to the concept and evidence for "brain death." Gordon Wolstenholme and Maeve O'Connor, eds., Law and Ethics of Transplantation: A Ciba Foundation Blueprint (London: J and A Churchill, Ltd., 1968), 67, 72–73; Harold M. Schmeck, "Symposium Hears Transplant Plea," New York Times, 9 September 1968, 23.

²⁷ Walter Robinson quoted in Eman Quotah, "Organ Donation: The Feds, Film, and Family," Harvard Public Health Review, Winter 2002, http://www.hsph.harvard.edu/review/review_winter_02/alumorgan.html, accessed 5 August 2008; Robin Cook, Coma (Boston: Little, Brown and Company, 1977).

²⁸ R. Converse, "But When Did He Die? Tucker v. Lower and the Brain-death Concept," San Diego Law Review, 1975, 12, 424–435; Anon., "Controversy on Coast," New York Times, 25 August 1968, 50; Anon., "Heart Operation Key Issue in Trial," New York Times, 29 October 1973, 5; Anon., "How to Define Death Is the Issue in Murder Trial," New York Times, 20 May 1974, 23; Anon., "Shooting That Led to an Implant Produces Manslaughter Verdict," New York Times, 24 May 1974, 20; Harold A. Schmeck, "Brain Death: When Does Life Cease?" New York Times, 4 June 1972, E7; Veatch, Transplantation Ethics, 43–52.

²⁹ Alexander M. Capron, "To Decide What Dead Means," New York Times, 24 February 1974, 168.

³⁰ Jonsen, Birth of Bioethics, 242. Sociologists Fox and Swazey referred to "conceptual confusion and emotional unease" about brain death, Spare Parts, 59–63.

³¹ The model statute read: "An individual who has sustained either (1) irreversible cessation of circulation and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made with accepted medical standards." President's Commission, Defining Death, 1–12, 24–30, 73. Thirty-seven states had passed the Uniform Determination of Death Act by December 1983. Frank J. Veith, "Define Brain Death," New York Times, 17 December 1983, 23. There has never been absolute consensus on the whole brain standard in the United States, with some arguing for a less stringent "higher brain" standard and a few maintaining we should return to solely the cardiopulmonary standard. See for example, Veatch, Transplantation Ethics, 53–83, and Lock, Twice Dead, 125.

³² Al Gore testimony, National Organ Transplant Act; Hearing before Subcommittee on Health of Ways and Means Committee, House of Representatives, 98th Congress, 2nd session, on H.R. 4080, February 9, 1984, 19.

³³ Al Gore testimony, Hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, 98th Congress, first session, on H.R. 4080, 29 July and 17 and 31 October 1983, 8–9, 111, 123–5. Quotation on p. 9. See also Gene A. Pierce, "Legislative Perspectives on the Development of the End–Stage Renal Disease Network and the National Organ Procurement and Transplantation Network," in Principles of Organ Transplantation, ed. M. Wayne Flye (Philadelphia: W.B. Saunders, 1989), 652–63; Steven J. Peitzman, Dropsy, Dialysis, Transplant (Baltimore, MD: Johns Hopkins University Press, 2007), 114–6.

³⁴ Thomas Starzl testimony, Hearings before the Subcommittee on Health and the Environment, 1983, 109.

³⁵ Edward Brandt testimony, Hearings before the Subcommittee on Health and the Environment, 1983, 146; and Brandt testimony, National Organ Transplant Act Hearing, 1984, 41.

³⁶ Gary Friedlander testimony, Hearings before the Subcommittee on Health and the Environment, 1983, 259.

³⁷ Thomas Starzl testimony, Hearings before the Subcommittee on Health and the Environment, 1983, 228, and National Organ Transplant Act Hearing, 1984, 104; Robert Mendez testimony, Hearings before the Subcommittee on Health and the Environment, 1983, 317.

³⁸ Comments by Henson Moore, National Organ Transplant Act Hearing, 1984, 109.

³⁹ See Thomas Starzl testimony, National Organ Transplant Act Hearings, 1984, 108–10; see also testimony of Oscar Salvatierra, President of the American Society of Transplant Surgeons, and others, Hearings before the Subcommittee on Health and the Environment, 1983, 29–41, 187–97, 228–9, 301–4, 329–30.

⁴⁰ Oscar Salvatierra testimony, Hearings before the Subcommittee on Health and the Environment, 1983, 330. See also Salvatierra testimony, National Organ Transplant Act Hearing, 1984, 92.

⁴¹ The House of Representatives voted 396 to 6 in favor of the law. National Organ Transplantation Act, Hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, 101st Congress, 2nd session, on H.R. 3968, a bill to amend the Organ Transplant Amendments Act of 1988 to Change effective date, April 20, 1990, 1.

⁴² Public Law 98–507, 98th Congress. 98 Stat. 2339. 19 October 1984.

⁴³ Task Force on Organ Transplantation, Organ Transplantation: Issues and Recommendations; Report of the Task Force on Organ Transplantation (Washington, DC: U.S. Department of Health and Human Services, 1986).

⁴⁴ Task Force on Organ Transplantation, Organ Transplantation, 24, 87–89.

⁴⁵ Ibid., 85–89. See also Jed Adam Gross, "Playing with Matches without Getting Burned; Public Confidence in Organ Allocation," in A Death Retold: Jesica Sanitllan, the Bungled Transplant, and Paradoxes of Medical Citizenship, ed. Keith Wailoo, Julie Livingston, and Peter Guarnaccia (Chapel Hill: University of North Carolina Press, 2006), 180–204.

⁴⁶ The Omnibus Budget Reconciliation Acts in 1986 and 1987 gave HHS responsibility for monitoring each OPO's performance and declared that hospitals meet certain criteria about organ transplantation or lose Medicare reimbursement money. HHS also was given authority to review UNOS membership requirements and policies. "HRSA Contracts Unify Organ donor and Transplant Information Networks," Pub. Health Rep., 1987, 102, 452; Prottas, The Most Useful Gift; 14–19, 44–45; Margaret Engel, "Organ Network Dies in Reagan Plan," The Washington Post, 11 January 1987, A11; National Organ Transplants, Hearing before the Subcommittee on the Health and the Environment of the Committee on Energy and Commerce, House of Representatives, 100th Congress, 1st session, 2 April 1987; 1–2; 20–23.

⁴⁷ Some interested and involved private individuals could also be members.

⁴⁸ Prottas, The Most Useful Gift, 138–9. UNOS received the federal contract on 30 September 1986. Its board was restructured to meet the requirements of the national task force. Statement of John C. McDonald, president, UNOS, National Organ Transplants Hearing, 1987, 43–50.

⁴⁹ The OPTN's current membership, board of directors, and purpose can be found on UNOS website at http://www.optn.org/policiesAndBylaws/charterAndBylaws.asp, accessed 12 February 2009.

⁵⁰ By 1987, UNOS had a twenty-four-hour, voice-activated computer to assist organ matching and was handling over 150 calls each day. Its recommended procedures had improved procurement, increasing the number of multi-organ donors and decreasing the number of kidneys that were discarded or exported outside the United States. Anon., "Organ Match Gets High-tech Help," The Advertiser, 19 September 1987, http://www.lexisnexis.com/us/lnacademic.

⁵¹ Prottas, The Most Useful Gift, 141–2.

⁵² Comments by John Dingell, Organ Transplant and Bone Marrow Donor Reauthorization, Hearings before the subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, 103rd Congress, 1st session, 22 April and 19 May 1993, 3. See also Engel, "Organ Network Dies," A11; Don Colburn, "Transplants: Who Lives? Who Decides? Doctors Can Make Them Work—But Can Society Make Them Fair?" Washington Post, 20 January 1987, Z1; "Backers of Organ Gifts Criticize Reagan Cuts," The New York Times, 13 January 1987, C9; Comments of Henry Waxman and Al Gore in National Organ Transplants, 1–4.

⁵³ Testimony of John C. Dingell, Charles Fiske, Craig Irwin, and Andreas Tazakis, Organ Transplant and Bone Marrow Donor Reauthorization, 3–6, 67–71, 51–64, 109–23. Quotation from Pittsburgh surgeon Tazakis on p. 121.

⁵⁴ Randal Bollinger testimony, Organ Transplant and Bone Marrow Donor Reauthorization Hearings, 80–88, 126. Quotation on p. 81.

⁵⁵ The arguments made at the 1996 hearings echoed some made at the 1993 hearings and anticipated those made after the final rule was released in 1998. UNOS announced that 95 percent of its members supported its policies but also seemed shocked at the number of complaints it received. "Patient Advocacy Group Condemns UNOS Interference with Government Hearings," National Transplant Action Committee press release, PR Newswire, 9 December 1996, http://www.lexisnexis.com/us/lnacademic; "Transplant Community Overwhelmingly Supports UNOS," UNOS press release, PR Newswire, 6 December 1996, http://www.lexisnexis.com/us/lnacademic; Paul Recer, "Patients Say Transplants Should Go First to the Sickest," Associated Press Online, 10 December 1996, http://www.lexisnexis.com/us/lnacademic; Rick Weiss, "A Searing Debate over a Life-and-Death Policy," Philadelphia Inquirer, 15 December 1996, E3; "Some Patients Object to Rule Change on Who Gets Scarce Livers," New York Times, 18 November 1996, A15; Ann Mongoven, "Federal Hearings on Liver Transplant Allocation and Donation," BioLaw, 1997, II, S373–89.

⁵⁶ Putting Patients First: Resolving Allocation of Transplant Organs, Joint Hearing before the Subcommittee on Health and Environment of the Committee on Commerce, House of Representatives, and the Committee on Labor and Human Resources, U.S. Senate, 105th Congress, 2nd session, 18 June 1998, 98–106.

⁵⁷ The wait could vary even within the same state, as in Kentucky where the median waiting time for livers was 38 and 226 days at different centers. Donna Shahala is quoted in "HHS Rule Calls for Organ Allocation Based on Medical Criteria, Not Geography," Health Resources and Services Administration (HRSA) Press Release, 26 March 1998, archived at http://www.hhs.gov/news/press/1998pres/980326a.html, accessed 12 November 2008.

⁵⁸ Donna Shalala testimony, Putting Patients First, 1998, 69–86; quotation on p. 77. See also Weiss, "New Rules for Organ Waiting Lists," Washington Post, 27 March 1998, A1.

⁵⁹ See for example, the Joint Statement on the Organ Allocation Provisions in the OPTN Rule, Putting Patients First, 17–26. "Campaign for Transplant Patient Fairness Weighs in on UNOS Plan, Calls on HHS to Protect Patient Interests, U.S. Newswire, 13 March 2000, http://www.lexisnexis.com/us/lnacademic.

⁶⁰ Apparently President Clinton had used the phrase "sickest first" when the regulations were first released, leading to understandable confusion about whether HHS recognized the very sickest might not always be the best candidates. Putting Patients First, 90.

⁶¹ Tom Meredith testimony, Putting Patients First, 33.

⁶² Besides saying they were losing their fair share, some argued that if more organs left the community in which they were donated, local people would be upset and stop donating. Letter from Congressional Representatives to Donna Shahala, 3 June 1998, included in Putting Patients First, 65–66, 66; Anon., "Fighting over Organs: The War over Transplants: States v. Washington," The Economist, 2 May 1998, 26–31.

⁶³ Thomas Barrett testimony, Putting Patients First, 59.

⁶⁴ Sheryl Gay Stolberg, "Patients' Lives on the Line in Battle over Transplants," New York Times, 25 March 1998, A1; Weiss, "A Searing Debate," E3; University of Pittsburgh Medical Center, "Liver Allocation Policies Should Serve Public's Interest Not Transplant Centers" PR Newswire, 10 December 1996, http://www.lexisnexis.com/us/lnacademic.

⁶⁵ Donna Shalala testimony, Putting Patients First, 69–86, 76, and 77.

⁶⁶ "Spending Bill Will Delay Organ Transplant Policy Rules," Reuters Health Medical newswire, 19 October 1998, http://www.lexisnexis.com/us/lnacademic; Walter K. Graham, "The Organ-Transplant Controversy," The Washington Post, 6 August 1997, A18. See also Donna Shalala and Lawrence Hunsicker testimony, Putting Patients First, 93–97, 180, 84.

⁶⁷ Claude Earl Fox quoted in Laura Meckler, "Transplant World in Nasty Fight over New Rules," Associated Press Online, 30 May 1998, http://www.lexisnexis.com/us/lnacademic; Donna Shalala quotation in Putting Patients First, 97.

⁶⁸ Meckler, "Transplant world in nasty fight"; Anon., "Patient Advocates Reject Transplant Network's Proposal to Revise Pending Federal Regulations," U.S. Newswire, 15 September 1999, http://www.lexisnexis.com/us/lnacademic; James Childress, a member of the original national task force on organ transplantation, said he was discouraged by the adversarial nature of the discussions about allocation. Childress testimony, Putting Patients First, 200.

⁶⁹ Walter Graham, quoted in Stolberg, "Patients' Lives on the Line."

⁷⁰ In 1996 UNOS had already portrayed the possibility of regulations as an "unprecedented federal takeover." Quoted in Rich Weiss, "Who Should Get Liver Transplants? As Demand Far Outpaces Donors, Federal Officials May Revamp Rules," Washington Post, December 9, 1996, A1.

⁷¹ D'Alessandro, "Hostile organ takeover."

⁷² See, for example, the exchange of comment letters between two surgeons. Dr. John J. Fung, "We Need an Equitable, National System of Organ Distribution," Washington Times, 14 January 1998, A16; John Rabkin, "Patient Care vs. Market Share," Washington Times, 27 December 1997, C1. In 1996 when HHS was holding hearings on the liver allocation policy, UNOS president James Burdick was quoted as lamenting "this unfortunate politicization." Quoted in Putting Patients First, 100.

⁷³ Charles Fiske quoted in anon., "UNOS: Some Call for More Public Accountability," American Health Line news wire, 10 April 2000, http://www.lexisnexis.com/us/lnacademic; Brigid McMenamin, "The Organ King," Forbes, 1999, 164, 164–7.

⁷⁴ John Dingell quoted in Juliet Eilperin, "House Acts to Reject Rules on Transplants; Voting 275–147, Lawmakers Side With Private Network in Dispute with HHS," Washington Post, 5 April 2000, A2.

⁷⁵ Allies in the Senate included two of the most liberal Senators, Charles Schumer of New York and Richard Durbin of Illinois, and two of the most conservative, Peter Fitzgerald of Illinois and Rick Santorum of Pennsylvania. Anon., "Senators Introduce Organ Transplant Bill," Reuters Health Medical News, 12 April 2000, http://www.lexisnexis.com/us/lnacademic.

⁷⁶ Comments of Bill Frist, Putting Patients First, 93.

⁷⁷ Walter Graham, quoted in Meckler, "Transplant World in Nasty Fight over New Rules"; Dave Davis and Joan Mazzolini, "Organ Centers Oppose Oversight; Allocation Rules May Change," The Times Picayune, 24 November 1996, inserted into the record in Putting Patients First, 102. See also Walter K. Graham, "The Organ-Transplant Controversy," The Washington Post, 6 August 1997, A18 and Putting Patients First, 34.

⁷⁸ Lawrence Hunsicker testimony, Putting Patients First, 136.

⁷⁹ Lawrence Hunsicker testimony, Putting Patients First, 178 and 181; Davis and Mazzolini, "Organ Centers Oppose Oversight."

⁸⁰ Donna Shalala testimony, Putting Patients First, 78.

⁸¹ Claude Fox, quoted in Meckler, "Transplant World in Nasty Fight over New Rules."

⁸² Donna Shalala testimony, Putting Patients First, 110.

⁸³ "Spending Bill Will Delay Organ Transplant Policy Rules," Reuters Health Medical newswire, 19 October 1998, http://www.lexisnexis.com/us/lnacademic; Mary Jacoby, "Organ Transplants May Go Nationwide," St. Petersburg Times, 26 November 1999, 1A.

⁸⁴ Committee on Organ Procurement and Transplantation Policy, Institute of Medicine, Organ Procurement and Transplantation; Assessing Current Policies and the Potential Impact of the DHHS Final Rule (Washington, DC: National Academy Press, 2000), http://books.nap.edu/catalog/9628.html, accessed 10 November 2008, 1–14, 14.

⁸⁵ Anon., "NTAC Condemns House Commerce Committee Chairman Bliley for Latest Attempt," U.S. Newswire, 17 November 1999, http://www.lexisnexis.com/us/lnacademic; Anon., "UNOS Statement on HR 1180," PR Newswire, 17 December 1999, http://www.lexisnexis.com/us/lnacademic; Anon., "Shalala, Congress Agree on Organ Transplant Plan," Reuters Health eLine News, 12 November 1999, http://www.lexisnexis.com/us/lnacademic; Jacoby, "Organ Transplants"; Anon., "HHS Amends Organ Transplant Rules," Reuters Health eLine News, 18 October 1999, http://www.lexisnexis.com/us/lnacademic; Anon., "HHS Amends Donor Rules in Face of Criticism," Washington Post, 19 October 1999, A7; Anon., "Organs: Online UNOS Database Provides Limited Info," American Health Line, 9 September 1999, http://www.lexisnexis.com/us/lnacademic.

⁸⁶ Organ Procurement and Transplantation Network Amendments of 1999, Hearing before the Subcommittee on Health and Environment of the Committee on Commerce, 106th Congress, 1st session, on H.R. 2148, 22 September 1999; Anon., "Organ Donation: Comt. Blocks White House Revisions," American Health Line, 14 October 1999, http://www.lexisnexis.com/us/lnacademic.

⁸⁷ Ted Kennedy quoted in Anon., "Organ Allocation: Senate Committee Passes Compromise," American Health Line, 13 April 2000, http://www.lexisnexis.com/us/lnacademic. See also Laura Meckler, "Transplant Fight Shifts to Senate," Associated Press Online, 5 April 2000, http://www.lexisnexis.com/us/lnacademic; Eilperin, "House Acts to Reject Rules on Transplants"; "Organ Transplant: House and Senate Negotiations Fail," American Health Line, 19 October 2000, http://www.lexisnexis.com/us/lnacademic.

⁸⁸ Laura Meckler, "New Contract for Transplant Network May Settle Fight," Associated Press newswire, 29 September 2000, http://www.lexisnexis.com/us/lnacademic; Walter Graham, "Statement of Walter Graham, UNOS Executive Director, On HHS Selection of an Alternative Scientific Registry Contractor," PR Newswire, 28 September 2000, http://www.lexisnexis.com/us/lnacademic; Karen Pallarito, "UNOS Retains Control of Transplant Network with New Multimillion-dollar Contract," Reuters Health Medical News, 29 September 2000, http://www.lexisnexis.com/us/lnacademic; Anon., "Organ Transplant: House and Senate Negotiations Fail," American Health Line, 19 October 2000, http://www.lexisnexis.com/us/lnacademic.

⁸⁹ UNOS lost one of the contracts it had with the government, the one which gave it responsibility as the scientific registry that analyzed all of the nation's data on all transplant recipients. Laura Meckler, "New Contract for Transplant Network May Settle Fight." The Institute of Medicine declared, "The polemical nature of the debate has increased public skepticism about the integrity and fairness of the system." Quoted in Organ Procurement and Transplantation, 2.

⁹⁰ Walter Graham, "The ‘Yin and Yang’ of UNOS," UNOS Update, July–August 2008, 8. UNOS, "Liver Allocation Policy Refinements Approved by OPTN/UNOS Board," UNOS press release, PR Newswire, 15 November 2001, http://www.lexisnexis.com/us/lnacademic; Anon., "Organ Transplants: UNOS OKs Need-Based Distribution Plan," American Health Line, 16 November 2001, http://www.lexisnexis.com/us/lnacademic; "Patient Advocates Urge Transplant Network to Comply with Federal Rule Requiring Fair Organ Allocation Policy," U.S. Newswire, 15 November 2001, http://www.lexisnexis.com/us/lnacademic. In response to the regulations, UNOS also dramatically revised its lung allocation system, the initial results of which seem equally positive. Benjamin Kozower, et al., "The Impact of the Lung Allocation Score on Short-term Transplantation Outcomes," J. Thorac. Cardiovas. Surg., 2008, 135, 166–171.

⁹¹ Anon., "Organs: UNOS Approves New Liver Distribution Plan," American Health Line newswire, November 17, 2000, http://www.lexisnexis.com/us/lnacademic.

⁹² D'Alessandro, "Hostile organ takeover."

⁹³ Adrian Kantrowitz admitted, "The world's outstanding cardiovascular surgeons underestimated the problems to be solved before the procedure could become routine." Kantrowitz, "America's First Human Heart Transplantation: The Concept, the Planning, and the Furor," ASAIO Journal, 1998, 44, 251. See also, Anon., "Saving New Hearts," Newsweek, 7 January 1980, 39, and McRae, Every Second Counts, 272. Shumway is quoted in the Newsweek article.

⁹⁴ Joseph E. Murray, "Human Organ Transplantation: Background and Consequences," Science, 1992, 256, 1414.

⁹⁵ Statement of the Board of Medicine of the National Academy of Science, Science News, 9 March 1968, 233; Statement of the Judicial Council of the AMA, quoted in George W. Miller, Moral and Ethical Implications of Human Organ Transplants (Springfield, Illinois: Thomas, 1971), 93–94; Herrman L. Blumgart, "The Medical Framework for Viewing the Problem of Human Experimentation," Daedalus, Proceedings of the American Academy of Arts and Sciences, 1969, 98, 248–74.

⁹⁶ They cited the House subcommittee on Health and Welfare, in particular, for stimulating "greater communication and cooperation among the professionals involved in organ transplantation." Statement of the American Society of Transplant Surgeons, Robert J. Corry, president, National Organ Transplants, 38–40, 38.

⁹⁷ Stolberg, "Patients' Lives on the Line."

⁹⁸ Bob Inglis testimony, Putting Patients First, 67.

⁹⁹ Mongoven, "Federal Hearings on Liver Transplant Allocation and Donation."

¹⁰⁰ Putting Patients First, 94.

¹⁰¹ Putting Patients First, 138; Prottas, The Most Useful Gift, 153.

¹⁰² M.M. Abecassis, et al., "Transplant Center Regulations—A Mixed Blessing? An ASTS Council Viewpoint," Am J. Transplant, 2008, 8, 2496–502; The Organ Procurement and Transplantation Network, Policies, http://www.optn.org/policiesAndBylaws/publicComment/, accessed 15 December 2008.

¹⁰³ Comments by Walter Mondale, National Commission on Health Science and Society, 13; Norman Shumway quoted in National Commission on Health Science and Society, 149.

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