 Bob Trug is professor of medical ethics, anesthesiology and pediatrics at the Harvard Medical School and is a senior associate in critical care medicine at the Children's Hospital in Boston. Bob received his medical degree from UCLA and holds a master's degree in philosophy from Brown. Dr. Trug is the director of the clinical ethics program in the division of medical ethics and in the Department of Social Medicine at the Harvard Medical School and he also directs the Institute for Professionalism and Ethical Practice at the Children's Hospital. Bob is widely published in the field of bioethics. He recently wrote some national guidelines for providing end-of-life care in the intensive care unit and is the principal investigator on an R1 grant from NIH to improve end-of-life care in pediatric ICU's. I could go on. I think time restrains me. Please join me in welcoming Bob Trug. Thank you, Mark, for inviting me and for putting together this panel. I'd like to thank the McLean family for your support over all the years in creating this wonderful center and in particular for making today possible. Art and Jim, thanks for being here with me as well. I was surprised at really, we agree on so many things, but I think there'll still be a few key points where we're going to have something to talk about here. So I'm going to talk about some of the issues and determination of death in the context of organ donation and I thought I would divide my comments here into two parts. Act one, if you will, to lay out the problem and then act two to talk about what we should do about it. So let's get started here. What is the problem? Jim very nicely reviewed this, but I'm going to do it briefly again. Remember that we have two pathways for organ donation. There's the brain death pathway on the left and the DCD pathway on the right. We're premised on determining that the patient is dead, the dead donor rule. In the brain death pathway, we determine the death on the basis of the irreversible loss of all the brain functions and on the DCD pathway on the irreversible loss of circulatory functions. Now, again, this is all premised on the dead donor rule. I want to emphasize that this isn't actually a law. This was a phrase that was coined by John Robertson in 1999 to express a sort of general ethical assumption that underlies how we think about the ethics of organ transplantation. And there's various ways of putting it. A couple of options are that vital organs for transplantation may only be procured from patients who are dead or a little bit different. Physicians may not cause death when procuring vital organs for transplantation. And so, as Jim said, we now have these enshrined in our law in the Uniform Determination of Death Act, which lays these two things out clearly. One, spelling out brain death for supporting brain death donation. One, spelling out circulatory death supporting DCD donation. So let's talk first a little bit about brain death and what it means. Now, in 1981, when the UDDA was created, people said, well, one of the things that's nice about it is that it's pretty clear. But no one's really laid out a philosophical foundation for why these findings should mean that a person is dead. And that same year, Jim and his colleagues published this paper, which I believe is one of the most important papers that's published in the Ethics of Organ Transplantation. It's a remarkable paper, and I agree with really all of the way that it is structured. And it provided what was needed, a sort of a philosophical basis for why these tests would show that a person was dead. And let me just review what I think were some of the key points that Jim and his colleagues made in this paper. He said, we define death as the permanent cessation of functioning of the organism as a whole. I continue to believe that that's the best definition of death that anyone has put out there. He said that what matters is function, not mechanism. That individual subsystems may be replaced, such as by pacemakers, ventilators or pressers, without changing the status of the organism as a whole. So for example, if a patient's on a ventilator, it doesn't matter that the breathing is being supplied by a machine. What matters is whether the breathing is occurring. So it's function, not mechanism. Jim also said that death is considered a biological occurrence, not unique to humans. So it needs to spread across species. And I think that that's true and very important. At this point, he was pushing back on those who were saying the human death should be something special. That we should say humans are dead when they have permanently lost consciousness, or they've lost personhood or something like that. And Jim was saying, no, this is a biological phenomenon. And I think that that's true. And he also said that death is an event, at least in theory, not a process, that the moment can be determined. And I think that all of these things were brilliant in 1981, and I think that they hold again today. Now let me expand on Jim's thesis a little bit, because he was actually reaching back to a line of thinking that went back to Claude Bernard, the French physiologist in the 1800s, through Walter Cannon in the 1930s at Harvard. The idea that life and death can be understood and defined in terms of thermodynamic concepts. And so Walter Cannon coined the term homeostasis. And if you follow this line of reasoning in short, it says that living organisms are distinguished from the inanimate world by their use of energy-consuming processes to oppose entropic forces and maintain homeostasis. And this, I think, is where Jim really captured this nicely in this phrase that life is the integrated functioning of the organism as a whole. And I just want to say a little bit more of that, because I think that there's an important element here that we need to remember. So if you look at this little yellow circle as an organism of some type, could be an amoeba, could be a tree, a dog, a human being, there's two sorts of forces that are active. There's these entropic forces, which are going towards chaos and disorganization. And there's these opposing forces that are maintaining homeostasis. And an organism is alive when these two forces are in balance. And then when the time comes that those forces that are maintaining homeostasis shrink, then the entropic forces take hold, we reach a point of no return, that moment of death, if you will. And then we say that this organism has died. I think that this is a unifying way of thinking about life and death that has origins now going back well over a hundred years. So now let's go back to Jim's paper in 1981. What did he say about this? He said, the criterion for cessation of the functioning of the organism as a whole is permanent loss of functioning of the entire brain. This criterion is perfectly correlated with the permanent cessation of functioning of the organism as a whole, because the brain is necessary for the functioning of the organism as a whole. And the data he cited was that destruction of the brain produces apnea and generalized vasodilitation. In all cases, despite the most aggressive support, the adult heart stops within one week and that of the child within two weeks. Now at the time Jim wrote this, drawing on data from the 1970s, it was true. And I think at that point it constituted a very robust defense of brain death as death. The problem is, it is no longer true. We now know that brain dead patients retain integrated functions and can live for years. Now you're going to say, well wait a minute, brain dead patients don't hang around for years. And that's true. And that's because with our understanding of brain death in this country, that diagnosis has become a legally enforceable definition of futility. So that we don't have to keep these patients on ventilators in the ICU any longer than we want to. But there have been cases over the years where families have convinced their clinicians to let them go home on ventilators. And when they do, we see that they're integrated just fine. They can live for years. In some cases over 14 years. Now why is that? Why does the data that Jim was drawing from in the 1970s differ from what we know today? And this will be the most technical part of my talk. So tune out for a second if you're not interested in that. But what I think is the difference is that intensive care has improved over the last several decades. And Alan Schumann has made a very nice analogy here between brain death and high cervical cord transaction, as when somebody is in an accident. Now in both cases what happens is the body is rather acutely separated from any sort of neural input. And in cases of high cervical cord transaction, the person immediately stops breathing and most of those people die in the field unless they're fortunate enough to have somebody around to resuscitate them and get them to an intensive care unit. But even then they're not out of the woods because now they go into a condition called spinal shock where they're extremely unstable, hemodynamically. And in the 1970s we couldn't keep these people alive. They died no matter how hard we tried. But intensive care has gotten better. And now what we know is that if you get these patients through the first days or weeks of instability that the body kind of gets used to the fact that the brain's not telling anything. And they stabilize out and they can live for years. And I think this is really a change in the science that has very, very much undermined the original rationale for why brain death was death. To summarize Schumann's work, he said, what is clear from a comparison with spinal cord injury is that the mainstream assertion that brain death represents the biological death of the human organism as a whole is untenable. And I do believe that's the best state of the science right now. Jim was right in saying that death is where we lose the integrated functioning of the organism as a whole. That's true, but brain death is not that. I want to say a few words about DCD. The donation after circulatory death pathway. So Jim's talked about this. Let me see if I can try to focus my comments on response that way. So we know we declare these patients dead two to five minutes after the onset of pulselessness. Now I would say that everyone agrees, and Jim would agree here too, that at least some DCD donors could be successfully resuscitated after two to five minutes of pulselessness. You know, this happens every day on the streets of our cities. The paramedics go out, somebody's had a pulseless arrest, and they are successfully resuscitated. So in this sense, their pulselessness is clearly not irreversible after this time frame. And in fact, Jim, in writing in 2006, said this. He said the DCD donor is dying, but is not yet dead after only five minutes of a systole. Now as Jim explained, more recently he has argued that permanence should legally substitute for irreversibility. I have a lot of concerns about this, and I'm going to be brief here. Maybe we can get to more in the discussion. As I understand permanence, what Jim means by it is that if the heart has stopped permanently, it means that since we're not doing anything, it soon will be irreversible. I think this is just a simple category mistake. You know, it's saying that here's somebody who is going to die soon. That's what permanence means. But they're dying. They aren't dead yet. I mean it's confusing a prognosis for a diagnosis. I think it is deeply flawed. And there's more to say about it, but this is fundamental to me. Another is what it means for how we think about death. So let me give you a little hypothetical here. Consider a DCD donor who has been declared dead after two minutes of pulselessness. So he's in the operating room with intention to donate, and he's been pulseless for two minutes. The surgeons say you are now dead and they are about to make skin incision and procure his organs, but in a moment of grief, his wife insists that he must be resuscitated. And whether or not it was a good thing to do, let's just imagine that the physicians do it, and let's imagine that they are successful, which would not be an unlikely outcome. What else can we say but that this person has come back from the dead? He's been diagnosed as dead, at least dead enough to have skin incision and organ procurement, and now he's alive. I think that this convoluted way of looking at it just tortures our common sense understandings of what it means to be dead. And as Jim himself said, he has acknowledged this. Because no mortal can return from being dead, he wrote, any resuscitation or recovery must have been from a state of dying, but not from death. And that seems very inconsistent with the way that permanence is being used. This is sort of the end of my first part of my comments. I do want to ask you to engage with me in just a little imagination. Imagine we lived in a world where the immunological hurdles to transplanting organs from pigs were overcome. Now, you know, pig organs are very much like human organs, and it would be great if we could transplant them into humans because we would have an unlimited supply of transplantable organs, but we haven't been able to overcome the immunological hurdles. But let's imagine we did, and I say this is an imaginary world, but it's not unthinkable that in the next 10 or 20 years, we could achieve this. And then the ethics of organ donation would really kind of devolve into the ethics of whether we should be eating bacon or something. You know, it would be really, I mean a question maybe, but not a question on the order of what we're talking about here. Now, in this world, which like I say maybe is not too far in the future, when we would not have a need for dead patients with live organs, would anyone really argue that our patients currently diagnosed as brain dead or our DCD organ donors are dead? I mean, I don't think so. I don't think that the arguments are at all compelling. And it leads me to question, is our understanding of the facts driving our conclusions, or is our desire for certain conclusions driving our interpretation of the facts? Are we gerrymandering the lines between life and death solely to meet social goals important as they are? And then the question is, in the long run, is this more likely to bolster or erode the confidence and trust of the public in the organ donation enterprise? Now, and just finishing here, Jim and I read this document differently. This is the 2008 report from the President's Council on Bioethics under the former President Bush shared by Edmund Pellegrino, one of the giants in our field. I read this actually. I mean, everything that I have told you up to now is pretty much affirmed in this report. So much so that they felt they needed to come up with yet another explanation for why brain death is death, which, to be honest, no one who's read it finds any more convincing than the ones that went before. So I don't take this as a ratification of what's gone before quite the opposite. Okay, let's turn to, now that we understand the problem, what should we do about it? And let me begin by saying I'm not really sure, but I'd like to think with you a little bit about it, and I'd also like to say that the public is looking to us as bioethicists for guidance. This is really where we do have our expertise as bioethicists. This is where I think we need to be accountable to the public. And so let me put it right out there. What's the big worry? The big worry is that if we acknowledge the truth, and I put truth in quotes because it's the truth as I see it, I acknowledge that, but if we acknowledge the truth about how death is defined for organ donation, we will destroy the public's trust in the organ transplantation process and that this will lead to the unnecessary death of many patients. This is possible. And if this is indeed so, then perhaps this is a situation where the consequences must trump the truth, where we must say, you know, we've got to come up with other ways of talking about this because we need to preserve the life-saving enterprise of organ transplantation. Now, in the book that I recently published with my friend and colleague Frank Miller, we provide a sort of a philosophical response to that worry. I'm not going to do that here. I'm not going to give you an ethical argument. If you're interested in that, I encourage you to read the book. I'm just going to have a few reflections about how this has evolved sociologically over the past few years that may give us some insights. And go back to a comment that the great anthropologist Margaret Mead made in 1963 where she said the greatest contribution of the Hippocratic of is that it separated the role of healer from that of killer, separated white magic from black magic. And so as I tried to put there in the graph, made a complete separation between the roles of causing death and allowing to die. And this has been a strong theme in medical ethics. So here's an article which Mark Siegler authored along with Edmund Pellegrino and other giants in the field that said this in the strongest possible way a few years ago, doctors must not kill. This is a deep theme in bioethics. But I'd like to suggest to you that sociologically we have been shifting away from that more towards what we might say as gray magic. And we might think that the beginning of this really goes back to the onset of mechanical ventilation several decades ago. Now clearly when we put patients on a ventilator, we are acting in the role of healers. We are trying to benefit them. But the question comes up then, when we stop ventilation, are we now killers? Now most of you who work in medicine would say, well that's crazy, we do this all the time, of course not. But it wasn't always that way. If we go back to the famous case of Karen Ann Quinlan in 1976, the reason the physicians didn't want to take that ventilator away at the request of her family was because they said to do so would be killing her. It's against medical ethics. And indeed the judge got it. The judge wrote, it seemed to be the consensus not only of the treating physicians, but also of the qualified experts, the bioethicists of the time, who testified that removal from the respirator would not conform to medical practices, standards, and traditions. She said, okay, I get it. She also said something very interesting. Even if it were to be regarded as homicide, it would not be unlawful. I'd like you to remember that phrase. And so what the Quinlan Court concluded was that the patient's right to privacy took legal precedence over physicians' concerns about the ethics of causing death. And so I would say from that case forward, an act that is causing death by withdrawing the ventilator was reframed as an omission, therefore in allowing to die, which made it acceptable in this Margaret Mead scheme. And again, I just do want to have come back to this phrase because over and over again I hear people say that, well, Bob Trug, no matter what you're talking about, if it comes to being a homicide, it's obviously illegal. I just want to say that the Quinlan Court did not necessarily think that way. Let me suggest a little bit more. So I've talked about mechanical ventilation. What about the palliative care that we do at the end of life? We all agree that patients have a right to be made comfortable at the end of life, even if that means receiving medications from us that hastens their death and provided certain conditions are met, the doctrine of double effect, et cetera. But what you can see is that these two circles now are starting to come together and we're starting to have little areas of gray between them. We've had the withdrawal of mechanical ventilation carve out. We've had the palliative care carve out where, well, yes, we are kind of causing death, but under certain circumstances there are other reasons why it's okay. Extending that analogy to palliative sedation, this is where we sedate patients to the point of unconsciousness and then take away food and fluids. Now, we still justify that the same way. We still say, well, we're not intending their death, that makes it okay, but we started to bring those two circles even closer together. It's getting harder to see where we're not playing a causal role here. Extend this now to physician aid and dying. Legal in three of our states, narrowly defeated in my state just several days ago, here again we're saying, well, physicians were not really causing death, but you can see that that causal role starts to grow. Physicians can't say they really had nothing to do with this in writing the prescription, et cetera. And then, of course, when we move into voluntary active euthanasia, that distinction dissolves entirely. And when that happens, the ethical question now shifts from whether it's ethical for physicians to cause death to other questions such as, is this compatible with our duty of non-maleficence? Are we harming patients when we do this? Is this done with the patient's consent indeed at the patient's request? And here we are also seeing a sociological shift. If we look at Gallup polling around the question of euthanasia, we see that in 1947, 37% of the population thought that under some circumstances they thought euthanasia would be ethical. In 2005, that has more than doubled, including 61% of individuals who identify themselves as evangelical Christians. So society is moving. So let me turn now to the hardest one. What about actually procuring organs then before death? We'll call it DPD, donation prior to death. I'll point out, first of all, that organ procurement is occurring in tandem with euthanasia in Belgium. So euthanasia is legal in Belgium, and there they are taking patients to the operating room for euthanasia, and they are donating their organs, all of their organs, just like in a brain-dead organ donor. And, you know, remember, I mean, Belgium is a civilized Western European country, shares many of the values and traditions that we do in our own country. Here in the United States, organ procurement in tandem with withdrawal of life support is also being actively considered. And let me just tell you about a case from last month that occurred. I do have permission to say where it was and the family and everything else, but I'm not going to do that. I'm just not quite comfortable with that. But I'll tell you, this was a large transplant center, and it wasn't in Boston. It involved a 52-year-old man who had a devastating stroke after really doing a lot to try to get him better. And he said, this isn't, you know, he's just not going to improve. We need to withdraw life support. But this was somebody who always wanted to donate his organs. But he wasn't brain-dead, and he wasn't thought to be a good D.C.D. candidate because he wasn't going to die soon enough after they withdrew his ventilator. So they were initially told no, and the family said, there's got to be some way. There's got to be some way that he can donate his organs. Why can't he be a living donor? Now, under living donor protocols, you know, if you want to give a kidney to your spouse or your child, you go to the operating room, the kidney is removed, and then you come back. Well, they said, well, let's do the same thing. Let's have him go to the operating room, let's take one of his kidneys and one of the lobes of his liver that can be donated to somebody else. We'll bring him back to the intensive care unit, and then we'll withdraw life support so that he can die. Well, the hospital ethics committee looked at this. They thought it was fine. The hospital administration thought it was fine. They thought it was compatible with the patient's wishes. They said there was no harm to him because he was going to be comfortable, and it conforms with the dead donor rule. They weren't causing death by taking his organs. So it all seemed to be fine. Now, this just played out over the last few weeks, but in the end, the transplant was denied. Why? Because we have a practice with living donation, not a law, but a practice that first person consent is required. I think it's generally a good idea. Don't get me wrong. But the patient, you know, him or herself has to say, I want to be a donor. This person couldn't do it. But I think we would agree that it's sort of a regulatory technicality. I mean, if this person would have been able to speak for himself, he probably would have agreed to the donation. But the point I want to make with this case is really look at what's happening sociologically. We are now coming up with strategies to do an end run around the dead donor rule. And, you know, take this a step further and people are talking about this. What if we took this gentleman to the operating room and put him on cardiopulmonary bypass? Then we could take, you could donate all of his organs, just like a brain dead organ donor. He could come back then to the ICU alive on cardiopulmonary bypass. He could have life support withdrawn and then he would die. Now, we would be observing the dead donor rule in letter, certainly not in spirit. But people are talking about things like these and I think it's increasingly showing how the dead donor rule does not seem to quite fit with how many people view what should be the core of transplantation ethics. I just want to give you one example from my own experience. This concerns a little girl that I took care of in my ICU, an eight-year-old little girl who, unfortunately, strangulation at home. We did everything we could to try to get her to recover. She did not and her family reached the point where they said, let's withdraw life support, but we really want her to be an organ donor. So we tried. We took her down to the operating room to be a DCD donor. Life support was withdrawn, but she did not die within the 60-minute window that was necessary. So we transported back to the ICU and she died a few hours later and was not a donor. Darshak Sangabi, a physician and reporter, wrote this case up in the New York Times magazine and he interviewed her father. And he wrote, Paul, her father, has some difficulty understanding why, if Jaden, his daughter, was going to die anyway. She could not have been put under general anesthesia, undergone surgery to donate her organs, and then been declared dead. And when they explained to him, well, yeah, but that would have violated the dead donor rule, he said, well, 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. So in closing here, let me sort of summarize where I was at in the first part of my talk. I believe that the arguments claiming that brain dead and DCD donors are dead are simply not coherent. They are tortuous and they don't fit with the science, they don't fit with logic, and I think they're misguided. And I also would say out of that that our current practices violate the dead donor rule. The transplants that I'm sure are occurring here in Chicago today and every other city in the country, I think are violating the dead donor rule. They're perfectly ethical, but not because they're conforming with the dead donor rule. I think that the line between allowing to die and causing death is not absolute. I mean, I think that things have changed over the last decades. Empirically, many of our end-of-life transplantation practices currently cross this line in various ways. And I've tried to say about how palliative care and other things work that way. I think that the dead donor rule may thwart legitimate desires by patients to donate organs, as we saw in the cases I described. Now that would be fine if we said, look, it's unethical to donate organs this way. So if it thwarts your desires, then that's just the way it has to be. But I don't think that's necessarily true. Primitively, these practices may be justified by appeal to other ethical principles, such as non-reliance and voluntary consent. And sociologically, I would say, these practices appear to have increasing public support. So what should we do now? Well, the question is, is the dead donor rule the ethical lynchpin in organ donation, as John Robertson said it was in 1999? If that's true, and it's really something that we cannot do without in terms of open public discussion, then perhaps the consequences must trump the truth. But I'm not sure that this common wisdom is correct. For one thing, it has really not been empirically studied. And any empirical studies that have been done tend to run in the other direction. And I think that our current practices, an end-of-life care and organ transplantation, cast doubt on this assumption. But in closing, I would say that the public is looking to... Well, normally they just look to art for guidance around the ethics of organ transplantation. But I think they're looking at the bioethics community more generally. And I think that we need to ask ourselves, where do we as bioethicists stand? So with that, I'll stop. Thank you very much for your attention.