The Dead-Donor Rule and the Future of Organ Donation
Robert D. Truog, M.D., Franklin G. Miller, Ph.D., and Scott D. Halpern, M.D., Ph.D.
N Engl J Med 2013; 369:1287-1289October 3, 2013DOI: 10.1056/NEJMp1307220
The ethics of organ transplantation have been premised on “the dead-donor rule” (DDR), which states that vital organs should be taken only from persons who are dead. Yet it is not obvious why certain living patients, such as those who are near death but on life support, should not be allowed to donate their organs, if doing so would benefit others and be consistent with their own interests.
This issue is not merely theoretical. In one recent case, the parents of a young girl wanted to donate her organs after an accident had left her with devastating brain damage. Plans were made to withdraw life support and to procure her organs shortly after death. But the attempt to donate was aborted because the girl did not die quickly enough to allow procurement of viable organs. Her parents experienced this failure to donate as a second loss; they questioned why their daughter could not have been given an anesthetic and had the organs removed before life support was stopped. As another parent of a donor child observed when confronted by the limitations of the DDR, “There was no chance at all that our daughter was going to survive. . . . I can follow the ethicist’s argument, but it seems totally ludicrous.”1
In another recent case described by Dr. Joseph Darby at the University of Pittsburgh Medical Center, the family of a man with devastating brain injury requested withdrawal of life support. The man had been a strong advocate of organ donation, but he was not a candidate for any of the traditional approaches. His family therefore sought permission for him to donate organs before death. To comply with the DDR, plans were made to remove only nonvital organs (a kidney and a lobe of the liver) while he was under anesthesia and then take him back to the intensive care unit, where life support would be withdrawn. Although the plan was endorsed by the clinical team, the ethics committee, and the hospital administration, it was not honored because multiple surgeons who were contacted refused to recover the organs: the rules of the United Network for Organ Sharing (UNOS) state that the patient must give direct consent for living donation, which this patient’s neurologic injury rendered impossible. Consequently, he died without the opportunity to donate. If there were no requirement to comply with the DDR, the family would have been permitted to donate all the patient’s vital organs.
Allegiance to the DDR thus limits the procurement of transplantable organs by denying some patients the option to donate in situations in which death is imminent and donation is desired. But the problems with the DDR go deeper than that. The DDR has required physicians and society to develop criteria for declaring patients dead while their organs are still alive. The first response to this challenge was development of the concept of brain death. Patients meeting criteria for brain death were originally considered to be dead because they had lost “the integrated functioning of the organism as a whole,” a scientific definition of life reflecting the basic biologic concept of homeostasis.2 Over the past several decades, however, it has become clear that patients diagnosed as brain dead have not lost this homeostatic balance but can maintain extensive integrated functioning for years.3 Even though brain death is not compatible with a scientific understanding of death, its wide acceptance suggests that other factors help to justify recovery of organs. For example, brain-dead patients are permanently unconscious and cannot live without a ventilator. Recovery of their organs is therefore considered acceptable if organ donation is desired by the patient or by the surrogate on the patient’s behalf.
More recently, to meet the ever-growing need for transplantable organs, attention has turned to donors who are declared dead on the basis of the irreversible loss of circulatory function. Here again, we struggle with the need to declare death when organs are still viable for transplantation. This requirement has led to rules permitting organ procurement after the patient has been pulseless for at least 2 minutes. Yet for many such patients, circulatory function is not yet irreversibly lost within this timeframe — cardiopulmonary resuscitation could restore it. So a compromise has been reached whereby organ procurement may begin before the loss of circulation is known to be irreversible, provided that clinicians wait long enough to have confidence that the heart will not restart on its own, and the patient or surrogate agrees that resuscitation will not be attempted (since such an attempt could result in a patient’s being “brought back to life” after having been declared dead).
Reasonable people could hardly be faulted for viewing these compromises as little more than medical charades. We therefore suggest that a sturdier foundation for the ethics of organ transplantation can be found in two fundamental ethical principles: autonomy and nonmaleficence.4 Respect for autonomy requires that people be given choices in the circumstances of their dying, including donating organs. Nonmaleficence requires protecting patients from harm. Accordingly, patients should be permitted to donate vital organs except in circumstances in which doing so would harm them; and they would not be harmed when their death was imminent owing to a decision to stop life support. That patients be dead before their organs are recovered is not a foundational ethical requirement. Rather, by blocking reasonable requests from patients and families to donate, the DDR both infringes donor autonomy and unnecessarily limits the number and quality of transplantable organs.
Many observers nevertheless insist that the DDR must be upheld to maintain public trust in the organ-transplantation enterprise. However, the limited available evidence suggests that a sizeable proportion of the public is less concerned about the timing of death in organ donation than about the process of decision making and assurances that the patient will not recover — concerns that are compatible with an ethical focus on autonomy and nonmaleficence.5
Although shifting the ethical foundation of organ donation from the DDR to the principles of autonomy and nonmaleficence would require creation of legal exceptions to our homicide laws, this would not be the first time we have struggled to reconcile laws with the desire of individual patients to die in the manner of their own choosing. In the 1970s, patients won the right to have ventilator use and other forms of life support discontinued, despite physicians’ arguments that doing so would constitute unlawful killing. Since that time, physicians have played an active role in decisions about whether and when life support should be withdrawn, and the willingness of physicians to accept this active role in the dying process has probably enhanced, rather than eroded, the public trust in the profession.
Our society generally supports the view that people should be granted the broadest range of freedoms compatible with assurance of the same for others. Some people may have personal moral views that preclude the approach we describe here, and these views should be respected. Nevertheless, the views of people who may freely avoid these options provide no basis for denying such liberties to those who wish to pursue them. When death is very near, some patients may want to die in the process of helping others to live, even if that means altering the timing or manner of their death. We believe that policymakers should take these citizens’ requests seriously and begin to engage in a discussion about abandoning the DDR.
The views expressed are those of the authors and do not necessarily reflect the policy of the National Insitutes of Health, the Public Health Service, or the Department of Health and Human Services.
Disclosure forms provided by the author are available with the full text of this article at NEJM.org.
From the Departments of Anesthesia and of Global Heath and Social Medicine, Harvard Medical School, and the Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children’s Hospital — both in Boston (R.D.T.); the Department of Bioethics, National Institutes of Health, Bethesda, MD (F.G.M.); and the Departments of Medicine, Biostatistics and Epidemiology, and Medical Ethics and Health Policy, and the Fostering Improvement in End-of-Life Decision Science (FIELDS) program — all at the University of Pennsylvania, Philadelphia (S.D.H.).
COMMENTS:JON HOLMLUND, MD | Physician – ONCOLOGY | Disclosure: NoneCARLSBAD CA
October 03, 2013
“Lean” toward protecting life
I believe it is helpful also to review the personal statement by the late Dr. Edmund Pellegrino, appended to the 2008 report on “Controversies in the Determination of Death” by the past President’s Council on Bioethics. At that time, Dr. Pellegrino rejected Miller and Truog’s reasoning as “a utilitarian device.” Perhaps their present appeal to nonmaleficience is in response to that; I do not follow the work in this area closely enough to know for sure. In any event, while agreeing that current definitions of death are problematic, tending to favor a cardiopulmonary definition of death, allowing that “ethically sensitive” protocols for controlled donation after cardiac death were being developed, and calling for prudence in decision-making, Dr. Pellegrino also argued that “[r]elaxation of the DDR is a morally unacceptable and logically specious way to deal with the uncertainties of the criteria for death of the donor.” Given “the imprecisions of decisions at the life-death interface,” we must, he concluded, “lean” in the direction of protecting the donor’s life. Read the whole thing. Here is a link: http://bioethics.georgetown.edu/pcbe/reports/death/pellegrino_statement.htmlPAUL CARPENTIER, MD | Physician – FAMILY MEDICINE | Disclosure: NoneGARDNER MA
October 02, 2013
It is a sad state of medical science when the only way that remains for a doctor to help his patient is to convince another doctor to kill his patient. The idea of removing the DDR is first dependent on the acceptance of the concepts of abortion and assisted suicide. We must first either dismiss the human dignity of one patient or assign it a value below that of another. Only then can a doctor or a culture accept the notion of killing a person for a utilitarian purpose. This is part of the same logic that we fought in WWII. You will recall that the physicians of the concentration camps decided to use the prisoners before they were killed. Prior to that, the German universities and medical societies had accepted the notions of killing patients for a variety of reasons. We would be wise to study 1920’s German medicine and the ethics that they invoked. This occured well before the political powers changed hands.CHARLES VAN BUREN, MD | Other | Disclosure: NoneHOUSTON TX
October 02, 2013
Missing the point
This is a proposal which specifically shows how little the authors know about organ donation and generally the error in using anecdotes to craft public policy. The only useful contribution the federal government has made to organ donation was to emulate best practices at productive organ banks to improve production in poorly functioning organ banks. This improvement in donation was transient as the.government shifted the metric for judging organ bank performance from focusing on the process of organ donation rather than the actual organ donors recovered. Needles to say , this shift in focus converted some of the worst performing organ banks in the country to top performers based on the self reported data provided. Rather than the contortionist policy proposal advanced the authors should examine the organ banks with some of the lowest numbers of donors per million population which are in the same region with very productive organ banks, studying the differences in management. This would have far greater impact that the policy they suggest.