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A Matter of Debate: Is it Time to Revisit the Dead Donor Rule?

Rukovets, Olga

doi: 10.1097/01.NT.0000438143.92193.a5
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Neuroethicists and critical care specialists respond to two opposing perspective pieces published in the Oct. 3 New England Journal of Medicine on the validity of the dead donor rule.

The “dead donor rule,” established in the 1960s to safeguard critically ill patients and their families from unethical practice in organ donation, ensured that patients were declared dead before any organs could be removed for donation. Death could be defined in one of two ways — circulatory death (permanent loss of function of the heart and lungs) and brain death (irreversible loss of function of the brain and brain stem).

Now, more than half a century later, clinicians and ethicists are asking: Is the dead donor rule (DDR) still relevant? Or should patients and their families be allowed the autonomy to opt for donation before death? In the Oct. 3 issue of the New England Journal of Medicine (NEJM), this contentious discussion of the DDR was highlighted in two opposing perspective pieces by James L. Bernat, MD, Ruth Frank professor of neuroscience at Dartmouth-Hitchcock Medical Center, and Robert Truog, MD, professor of medical ethics, anaesthesiology and pediatrics at Harvard Medical School, and colleagues. Dr. Truog favors revising the DDR, while Dr. Bernat said there are reasons to keep it in place. (See “Back and Forth” for details of the two viewpoints.)

Asked to comment on the controversy, neuroethicists and critical care specialists who were not involved with either article overwhelmingly felt the DDR should not be revised — but they told Neurology Today the debate raised evocative questions, which invited much needed discussion and insight.

Jeffrey I. Frank, MD, professor of neurology and surgery and director of neurocritical care at the University of Chicago Medical Center, told Neurology Today that the DDR is a “foundational assumption” that organ donation should never be the mechanism by which people die. As clinicians and as a society, Dr. Frank said, “if our ultimate goal is to preserve public trust and always focus on what's best for the patient, then the DDR seems to be a foundational cornerstone concept worthy of preserving.”

Dana Lustbader, MD, section head of palliative medicine and an intensivist in critical care medicine at the North Shore-LIJ Health System, said that the notion presented by Dr. Truog of critically ill patients and families wanting to make a “gift” of organ donation before death is not uncommon. “We have this come up in our own unit. I'm an intensivist and also a palliative medicine doctor, and very often families will say, ‘Can we make something good come from such a terrible tragedy?’ The patient would have wanted it, the family would like to donate, and lives could be saved — and it all sounds good, so what could be wrong with that?” But the problem really rests with the big picture of how that would appear to us as a society, explained Dr. Lustbader, who is also the assistant medical director for the New York Organ Donor Network.

Ultimately, she said, she worries that changing the DDR “would hurt the field of transplantation when there is already a desperate shortage of organs — 18 people die every single day, waiting for a lifesaving organ.”

Michael A. Williams, MD, medical director of the Sandra and Malcolm Berman Brain & Spine Institute, told Neurology Today that the paper by Truog et al. is not framing the entire ethical issue. “They speak a lot about autonomy, and they appropriately describe the need [for autonomy] — and from that try to create a justification for killing patients. In fact, in their paper, they say that [changing the DDR] would ‘require creation of legal exceptions to our homicide laws.’” Therefore, it's very important to understand that the DDR was created to prohibit killing patients by taking their organs as opposed to letting patients die and then and only then removing their organs.

Dr. Williams provided an example where a patient has a living will that specifically requests organ donation even if brain death is not yet determined — “That's autonomy. But autonomy is not the only value in ethics. Just imagine for a second that we do that — and then we have to think about if we can find a surgeon who is willing to perform the operation to remove the organs that directly results in death. So the surgeon has a stake in it, the anesthesiologist, the nurses, the respiratory therapists, and others who are involved in the organ procurement process all have a stake. So you can ask the question: Should they be compelled to participate in that process, or would they be permitted to exercise conscientious objection and request not to participate?”

There are many more stakeholders in the organ donation process than Dr. Truog and co-authors present, he said, including the potential donor and their family, the physicians and nurses, the potential organ recipients and their families, everybody on the transplant team, the hospitals and the health systems, the organ procurement organizations and transplant coordinators, the payors, the legislators and regulators, and society. “So, there are at least nine groups of stakeholders whose thoughts and feelings and values and even emotional responses have to be taken into account,” he said.

Responding to Dr. Truog's examples of families who were devastated by the inability to donate because of the DDR, Dr. Williams said that, even for those patients who are declared dead and who would like to donate their organs, this is still not always possible. They may not be matches for the blood or tissue type, or their serology may not allow it, he explained, “We should always inform families that we will do our best to honor their intent to donate, but that sometimes circumstances beyond our control prevent donation from happening.”

In his perspective piece, Dr. Bernat presented the public's support for organ donation as “broad but shallow,” and thus easily affected. “We can't underestimate how delicate the thought processes are for people, families, and the public regarding death pronouncement and organ donation. I think we have enough recent cases and sensationalized stories that tell us there remains lingering, albeit poorly founded, skepticism about the intergrity of the ‘organ donation industry,’” said Dr. Frank.

Specifically for patients with neurologic illness, Dr. Frank said, side-stepping the DDR could prove perilous. New practice in most cases would then allow organ donation based on a projected poor neurological prognosis. Unfortunately, prognostication in critically ill neurological patients, he said, is not an exact science — we are still in our infancy in this area of practice. “So, if one was to couple an incorrectly projected poor prognosis as the reason for which one actually ends up becoming an organ donor and dying through that process, then we have shifted from poor medical practice to an obscene macabre scenario.”

Although commentators told Neurology Today that they did not agree with Dr. Troug and colleagues, they all applauded the debate. “It is a very important process that Dr. Truog keeps on bringing up this question of whether the DDR is so important, is our vocabulary sloppy, is it inaccurate? Is death by neurologic criteria a real mechanism of death or is it something we made up but we just believe it strongly?

“I think that the conversation in the NEJM by Jim Bernat and Robert Truog — conversations and debates that they've been having for a long time — pushes our thinking; it demands of us to not be in a static mode particularly for this topic where our thoughts and understanding are still evolving. We need to welcome these conversations, constructively debate, tenaciously push our ideas, and challenge each other because that is how we will evolve to a better understanding and improve our practice. The public trust and medicine, in general, depends on us doing this,” said Dr. Frank.

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James L. Bernat, MD, the Louis and Ruth Frank Professor of Neuroscience at the Geisel School of Medicine at Dartmouth and a neurologist at Dartmouth-Hitchcock Medical Center, said that there are options to increase organ donation without violating the DDR. For example, he offered the Morrissey protocol, which promotes donation of both kidneys from critically ill patients who are not yet dead. “The idea is that this protocol does not violate the DDR because the death is not the result of removing the kidneys. It also allows the kidneys to be removed while they are still being perfused, so they'll be healthier for transplantation.”

One of the tragedies of deceased organ donation, he said, is the number of lost organs resulting from families who refuse consent for donation. There are many studies looking at ways to improve consent, Dr. Bernat added, including one that he and colleagues at Dartmouth-Hitchcock Medical Center conducted, which hypothesized that with the improvement of end-of-life care for the family and increased emotional support, there would be a higher rate of consent — “and that turned out to be true.” He said he also supports state donor registries, which allow individuals to register as organ donors and fill out a legal form — thus allowing the organ procurement organization to permit donation even if the family declines to provide consent contrary to the patient's expressed wishes.

Another current inefficiency in organ donation, Dana Lustbader, MD, section head of palliative medicine and an intensivist in critical care medicine at the North Shore-LIJ Health System, said, is that “we are lazy with our diagnosis of brain death. We do not make the diagnosis of brain death in a timely fashion.” In a Neurology study that Dr. Lustbader and colleagues published in 2011, they found that you only need one exam to determine brain death — not two. “We studied 1300 patients — and not one patient became ‘undead’ upon the second examination and the average interval between the two exams was nearly 20 hours.” Still, some hospitals, she said, continue to use two brain death determination exams.

She added that her institution, Northshore LIJ Hospital, is now participating in a multi-center study to look at recovering lungs from people who have had a cardiopulmonary arrest “and how could we make those lungs suitable for recovery and then transplantation.” We need to continue such innovative research efforts to improve organ donation without upsetting public trust, she pointed out.

—Olga Rukovets

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BACK AND FORTH: The Dead Donor Rule (DDR)

Robert Truog, MD: “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. ...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.’”



Dr. Truog: “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.”

Dr. Truog: “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.”

James L. Bernat, MD: “I believe that, although there are informed patients for whom this practice would work, violating the DDR is misguided and will lead fearful patients to lose trust in physicians and confidence in the organ-donation system and will result in an overall decline in organ donation.”



Dr. Bernat: “I believe that the DDR is an indispensable ethical protection for dying patients who plan to donate organs and one that strengthens public trust and confidence in our voluntary system of organ donation. Public support for organ donation is broad but shallow.”

Dr. Bernat: “Recognizing that the harms of abandoning the DDR exceeded the benefits, John Robertson proposed a two-part prudential test for assessing proposed changes to the rule, asking what effect they would have on the protection of vulnerable persons and on preserving the public trust. These essential questions need to be answered conclusively before our society considers abandoning the DDR.”

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•. Bernat JL. Life or Death for the Dead-Donor Rule. N Engl J Med 2013; 369:1289–1291.
    •. Lustbader D, O'Hara D, Goldstein M, et al.Second brain death examination may negatively affect organ donation. Neurology 2011; 76 (2): 119–124.
      •. Truog RD, Miller FG, Halpern SD. Perspective: The Dead-Donor Rule and the Future of Organ Donation. N Engl J Med 2013; 369:1287–1289.
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          © 2013 American Academy of Neurology