Stuart Youngner

In lieu of an abstract, here is a brief excerpt of the content:Back to the Future:Obtaining Organs from Non-Heart-Beating CadaversRobert M. Arnold (bio) and Stuart J. Youngner (bio)Organ Transplantation requires viable donor organs. This simple fact has become the Achilles' heel of transplantation programs. Progress in immunology and transplant surgery has outstripped the supply of available organs. Between 1988 and 1991, for example, the number of transplant candidates on waiting lists increased by about 55 percent, while the number of donors increased only about 16 percent.1 By the end of March 1993, more than 30,000 potential recipients awaited transplantation (United Network for Organ Sharing Database (UNOS) 1993). Every day six of these patients die prior to receiving a heart or liver transplant, while patients needing kidney transplants must tolerate a lower quality of life on dialysis (Grenvik 1992; Evans, Orians, and Ascher 1992).This scarcity is likely to get worse. As transplantation becomes more successful, it is being offered to sicker and older patients. Attempts to transplant other solid organs, such as small bowel and pancreas, will only fuel the demand for donors. However, the current source of organs is unlikely to grow. Most organs come from patients who have been declared dead by neurologic criteria (commonly referred to as "brain dead" or heart-beating cadaver donors (HBCDs) because their hearts are beating at the time of procurement). Estimates of the potential pool of HBCDs have been revised downward from 20,000-27,000 to roughly 10,000-12,000 (Nathan et al. 1991). Improvements in automobile safety and handgun legislation will likely lead to further reductions. Moreover, the rate of procurement from HBCDs has remained relatively flat despite extensive public awareness campaigns and legislation requiring hospitals to routinely request donation from families of dead patients (Caplan et al. 1992).If organ transplantation is going to continue to flourish, alternative [End Page 103] sources of organs must be found. Recently the University of Pittsburgh Medical Center (UPMC) proposed procuring organs from patients who have been declared dead by traditional cardiopulmonary rather than brain-oriented criteria after they or their families have decided to forgo life-sustaining treatment—hereafter referred to as the Pittsburgh protocol (UPMC Policy 1993). These patients are typically referred to as non-heart-beating cadaver donors (NHBCDs) because their hearts are no longer beating at the time of organ procurement.Although NHBCDs were a major source of transplantable kidneys prior to the institution of death by neurologic criteria, their usefulness was limited by "warm ischemia time." This term refers to the injury to tissues that occurs when the blood supply is interrupted and before the organs are cooled and reperfused. Under the Pittsburgh protocol, therapy is withdrawn in the operating room where a waiting surgical team removes organs immediately after death is declared. By controlling the place and time of death, it has been possible to minimize warm ischemia time and thus solve the technical problems previously associated with procurement from NHBCDs.The potential contribution of NHBCD organs is significant. Nathan (1992), using data from Delaware Valley Transplant Program, concludes that the use of severely brain injured, but not "brain dead" patients, would increase the donor pool by 20-25 percent. Moreover, unpublished data from the Pittsburgh organ procurement organization, the Center for Organ Recovery and Education (CORE), suggests that these organs, particularly kidneys, function as well as those procured from HBCDs (Broznick 1993).This volume is devoted to the ethical, psychosocial, and public policy implications of procuring organs from non-heart-beating cadaver donors after a discussion to forgo life-sustaining treatment. The genesis of this volume was a project in which we invited leading experts in transplantation, ethics, and public policy to use the Pittsburgh protocol as a starting point for exploring a broad range of issues associated with attempts to procure organs from NHBCDs. The issues raised by NHBCDs turned out to have important implications about the fundamental conceptual and moral assumptions underlying organ procurement.Although each of the papers in this volume can be read separately, we intend the volume to be read as a whole. Many of the latter pieces on the ethical implications of the policy are best understood in light of the earlier background papers...

: Protection of human subjects from investigators' conflicts of interest is critical to the integrity of clinical investigation. Personal financial conflicts of interest are addressed by university policies, professional society guidelines, publication standards, and government regulation, but "intrinsic conflicts of interest"—conflicts of interest inherent in all clinical research—have received relatively less attention. Such conflicts arise in all clinical research endeavors as a result of the tension among professionals' responsibilities to their research and to their patients and both academic and financial incentives. These conflicts should be disclosed to research subjects and managed as assiduously as are financial conflicts of interest

The transplantation and procurement of human organs has become almost routine in American society. Yet, organ transplantation raises difficult ethical and psychosocial issues in the context of “controlled” death, including the blurring of boundaries between life and death, self and other, healing and harming, and killing and letting die. These issues are explored in the context of the actual experiences of organ donors and recipients, brain death, the introduction of non‐heartbeating donor protocols, and the increasing reliance on living donors. The author draws on a thematic analysis of the way that organ transplantation is presented in the media, films, and science fiction and on his clinical experience as a psychiatrist working with transplant patients, their families, and the nurses and physicians who care for them

The dead donor rule—that persons must be dead before their organs are taken—is a central part of the moral framework underlying organ procurement. Efforts to increase the pool of transplantable organs have been forced either to redefine death (e.g., anencephaly) or take advantage of ambiguities in the current definition of death (e.g., the Pittsburgh protocol). Society's growing acceptance of circumstances in which health care professionals can hasten a patient's death also may weaken the symbolic importance of the dead donor rule. We consider the implications of these efforts to continually revise the line between life and death and ask whether it would be preferable to abandon the dead donor rule and rely entirely on informed consent as a safeguard against abuse.

Mandating psychiatric evaluation for patients who request physician‐assisted suicide may not offer the clearcut protection from possible coercion or other abuse that proponents assert. Competence itself is a complex concept and determinations of decisionmaking capacity are not straightforward, nor is the relationship between mental illness and decisionmaking capacity in dying patients clearly understood. And casting psychiatrists as gatekeepers in end‐of‐life decisions poses risks to the profession itself.

The Texas Advance Directive Act allows physicians and hospitals to overrule patient or family requests for futile care. Purposefully not defining futility, the law leaves its determination in specific cases to an institutional process. While the law has received several criticisms, it does seem to work constructively in the cases that come to the review process. We introduce a new criticism: While the law has been justified by an appeal to professional values such as avoiding harm to patients, avoiding the provision of unseemly care, and good stewardship of medical resources, it is applied incompletely. It allows physicians and institutional committees to refuse “futile” treatments desired by patients and families while at the same time providing no way of regulating physicians who recommend or even push “futile” treatments in similar cases. In this sense, the TADA is incomplete on its own terms

Two factors, medical science's growing control over the timing of death and the increasingly desperate need for organs, have led to a reopening of the debate about the definition of death and have forced a consideration of aspects of the determination of death that had never been addressed before. Without the pressing need for organs, the definition of death would have remained on the back shelf, the conversation of a few interested philosophers or theologians. This article examines some new questions raised by medical technology and the frantic search for new, morally acceptable sources of human organs over the past thirty years. This examination concludes that death itself is a social construct and that, in a pluralistic society such as ours, a conclusive definition of death or determination of the moment of death is out of the reach of both medical science and philosophy.

Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant step on the pathway to an eventual certification process for clinical ethics consultants

The current institutional focus on patient satisfaction and on surveys designed to assess this could eventually compromise the quality of health care while simultaneously raising its cost. We begin this paper with an overview of the concept of patient satisfaction, which remains poorly and variously defined. Next, we trace the evolution of patient‐satisfaction surveys, including both their useful and problematic aspects. We then describe the effects of these surveys, the most troubling of which may be their influence on the behavior of health professionals. The pursuit of high patient‐satisfaction scores may actually lead health professionals and institutions to practice bad medicine by honoring patient requests for unnecessary and even harmful treatments. Patient satisfaction is important, especially when it is a response to being treated with dignity and respect, and patient‐satisfaction surveys have a valuable place in evaluating health care. Nonetheless, some uses and consequences of these surveys may actively mislead health care.Our critique of patient‐satisfaction surveys takes into consideration three different ways patients may be “satisfied.” First is the provision of medically necessary care that actually improves their outcomes. The second concerns interventions that patients or families want but that are medically unnecessary and may negatively affect health outcomes. The third category—comprising factors that are less likely to affect health outcomes but may certainly contribute to a sense of dignity and well‐being—includes “humanistic” aspects of health care, such as good communication and treating patients with respect, as well as peripheral aspects, such as convenient parking and designer hospital gowns. These distinctions are important as we explore patient satisfaction and its implications.

While the bioethics literature demonstrates that the field has spent substantial time and thought over the last four decades on the goals, methods, and desired outcomes for service and training in bioethics, there has been less progress defining the nature and goals of bioethics research and scholarship. This gap makes it difficult both to describe the breadth and depth of these areas of bioethics and, importantly, to gauge their success. However, the gap also presents us with an opportunity to define this scope of work for ourselves and to help shape the broader conversation about the impact of academic research. Because of growing constraints on academic funding, researchers and scholars in many fields are being asked to demonstrate and also forecast the value and impact of their work. To do that, and also to satisfy ourselves that our work has meaningful effect, we must understand how our work can motivate change and how that change can be meaningfully measured. In a field as diverse as bioethics, the pathways to and metrics of change will likewise be diverse. It is therefore critical that any assessment of the impact of bioethics research and scholarship be informed by an understanding of the nature of the work, its goals, and how those goals can and ought to be furthered. In this paper, we propose a conceptual model that connects individual bioethics projects to the broader goals of scholarship, describing the translation of research and scholarly output into changes in thinking, practice, and policy. One of the key implications of the model is that impact in bioethics is generally the result of a collection of projects rather than of any single piece of research or scholarship. Our goal is to lay the groundwork for a thoroughgoing conversation about bioethics research and scholarship that will advance and shape the important conversation about their impact.

The National Institute of Mental Health (Bethesda, MD) reports that approximately 5.2 million Americans experience post-traumatic stress disorder (PTSD) each year. PTSD can be severely debilitating and diminish quality of life for patients and those who care for them. Studies have indicated that propranolol, a beta-blocker, reduces consolidation of emotional memory. When administered immediately after a psychic trauma, it is efficacious as a prophylactic for PTSD. Use of such memory-altering drugs raises important ethical concerns, including some futuristic dystopias put forth by the President's Council on Bioethics. We think that adequate informed consent should facilitate ethical research using propranolol and, if it proves efficacious, routine treatment. Clinical evidence from studies should certainly continue to evaluate realistic concerns about possible ill effects of diminishing memory. If memory-attenuating drugs prove effective, we believe that the most immediate social concern is the over-medicalization of bad memories, and its subsequent exploitation by the pharmaceutical industry.