Reexamining organ transplantation.

IT IS TIME TO CONSIDER A FUNDAMENTAL REEXAMINATION of the US system for transplantable organ procurement and allocation. This need arises from several important issues, including whether regional vs national allocation policies best ensure fair access to available organs; the alleged problems in procurement of human tissue under investigation by the Inspector General of the US Department of Health and Human Services; the application of new technologies for growing human pluripotent stem cells that may one day allow the manufacture of replacement organs and tissues autologous to their recipients; and perhaps most important, weaknesses and tensions in organ procurement policies that have produced chronic problems and shortfalls in the availability of life-saving solid organs. The article by Wendler and Dickert in this issue of THE JOURNAL is the latest indication of concerns about equity, reliability, and efficacy in organ procurement and transplantation that must stimulate change. From the vantage of ethics and public policy, the modern era of organ transplantation began in the mid 1960s as allogeneic organ transplantation first experienced a “crisis of success. ” Improvements in surgical technique, the evolving understanding of immunologic tolerance, and development of antirejection drugs shifted the paradigm from one of transplanting kidneys from identical twins and other immunologically similar relatives to transplanting organs from genetically unrelated living donors, and later, cadaver donors. At the same time, advances in hemodialysis and improved surgical outcomes led physicians to classify more patients with end-stage renal disease as suitable candidates for transplantation, thereby widening the gap between the demand for and supply of organs. The increasing need for cadaver organs prompted efforts to clarify who could authorize donation. Under the common law, no one has a property interest in a dead body, and the limited quasi-property interest in corpses rests with the next of kin, who are expected to arrange for appropriate disposition of the remains. As an expression of personal selfdetermination, competent adults can make an informed choice to donate a kidney while alive, but under common law a premortem decision to donate one’s organs (or body) is not binding on the next of kin after one’s death. To remedy this problem, in the mid 1960s the National Conference of Commissioners on Uniform State Laws (NCCUSL) initiated work on a model statute on anatomical gifting. The proposed Uniform Anatomical Gift Act (UAGA) permitted individuals to execute a simple declaration—a “uniform donor card”—to make an anatomical gift that would take effect at death; in addition, the statute listed, in rank order, the persons who could make such a gift “in the absence of actual notice of contrary indications by the decedent. ” Attention generated by the stunning medical achievement of heart transplantation beginning in December 1967 fueled public interest in the UAGA, and by 1972 the law had been adopted (in some form) by every state. Yet the report of heart transplantation created a new concern: how could physicians remove a “living” heart from a “dead” body and then transplant that heart into a body from which this essential organ had been removed but that was not “dead”? Common law cases “defining” death as the complete absence of heartbeat and breathing were decided long before total respiratory and circulatory support were technically possible. The UAGA authorized physicians attending potential donors to determine the time of death but provided no guidance about how such a determination was to be made. Lacking authoritative legal guidance, some physicians were reluctant to declare death in patients who met the criteria articulated by leading physicians for determining death largely based on lack of brain function. Moreover, when physicians did use those criteria, the legitimacy of their determination became an issue both in cases brought against transplant surgeons and in criminal cases against persons whose acts had caused the donor’s “brain death. ” To address this concern, about half the states adopted statutory “definitions” of death in the 1970s, and in 1981, a presidential commission, along with the NCCUSL, the American Medical Association, and the American Bar Association jointly proposed the Uniform Determination of Death Act. Within a few years, all but 3 states had adopted this or a similar statute. While these first 2 policy issues—the authority to make a donation and standards for determining death—seemed