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Thursday, September 7, 2006

Session 1: Ethical and Philosophical Issues in the Definition of Death

Discussion of Staff Working Paper by Alan Rubenstein, M.A.

I think we can proceed to the meeting itself.  We have revised the agenda in just one case.  Moving the discussion of living donation to session two and the discussion of the criteria for death to session one.  That is to accommodate some of the people who will be opening the discussion.  I hope that is acceptable.

Our previous discussions have been focused largely on organ procurement and today we have a number of relatively unexplored but very essential areas especially in the light of a potential report by the Council, and I say potential.

We will be looking at today the criteria of death, the question of living donation, the ethics of organ allocation, and some reflections on current and proposed policy.

We will be proceeding in the following way.  The staff has been working hard all summer on preparing summations of each of those issues which have been distributed to the members of the Council.

Staff members will be here available for clarification but the work they have done is a summation of discussions with all the members of the Council — not of the Council, excuse me, of the staff during the summer but reflecting on the discussions and contributions of the Council members in the meetings that led up to the summer.

I want to express my gratitude to all the staff who have worked hard during the summer to put this material together.  We hope that it will serve to bring you up to date on where we are at the present time and to lay open the areas we need to discuss further and the ethical issues, particularly those that may not have been addressed by other groups who are also studying this very, very important question of organ donation and procurement.

We are not looking forward to the outcome from this meeting of a set of recommendations by any means but rather an intermediate step in which we step back and look at where we have been, what the issues are before us, and what directions we might take in the future and how much emphasis we might put on each one of these subjects which I have enumerated for you at the beginning of the session.

I'd like to begin with the first session on the criteria for death.  And that paper has been prepared by Alan Rubenstein.  Alan is here at the table.  Eric Cohen, who acted as overall editor of all of these papers, is also to my right.  And, again, I re-emphasize, they are here to respond to questions  of clarification.

The papers have been distributed and our interest really is the response of the Council members and to give them an opportunity to give their thoughts on these issues which we have raised.

To open up the discussion, we have asked individual members of the Council, and they will be enumerated later on as they come up to their subjects, to open the discussion, to provide us an entry into it.   And from that point on, it is open to the Council members to carry the discussion further.

Our first discussion catalyst will be Dr. Ben Carson, a member of the Council.  It has been our custom, for those of you who are here for the first time, not to provide extended autobiographical or biographical summaries.  And, therefore, we will not repeat what is in the book itself.

Dr. Carson will open this discussion.  And I will ask him to bring us into the issue and, as they say... in medias res.

DR. CARSON:  Well, thank you very much.

You know this is — first of all, let me congratulate the staff for being able to take so many philosophical opinions and boil them down to a 50-plus-page treatise here.  That is quite a task.

You know one thing becomes apparent and that is it is very difficult to gain uniformity in terms of defining anything.  And as a neurosurgeon, obviously I've unfortunately had to deal with the whole issue of when someone is dead frequently, principally surrounding brain death.

In this paper, we talked about different types of brain death: whole brain death where really nothing intercranially is functioning in any adequate way versus, you know, the British standard of brainstem death which is mostly the only things that are left are reflexic in nature.

And each of them has, you know, their advantages in terms of trying to define things.  And there is, you know, physiological criteria of death as put forth by, you know, the Harvard criteria.

I don't know that we will have the possibility of really being able to define which one of those things is real or is the most factual because one thing becomes clear.

And that is people's religious beliefs, their feelings of whether their moral standards are being violated, questions of whether scientific standards are being violated enter into each one of these things.  And I don't know that there is any way to bring that all under one umbrella.

There is quite an extensive discussion on sort of to get around some of those moral issues, donation after cardiac death.  That way if you allow the heart to stop beating and, therefore, the brain to stop being perfused and all the other organ systems to die in the most traditional sense of death, then you remove a lot of the moral issues that have made this so controversial.

Now obviously, the issue there being now you are beginning to compromise organs that you clearly want to donate.  Now interestingly, some people have said let's just go around the whole idea of when death occurs and let's think about what is practical.  And let's think about how we are not violating the rights of any of the interested people.

Let's say, for instance, an individual has decided that they want to be an organ donor.  They have indicated that on their driver's license or elsewhere.  The family is in agreement.  But they are clearly not brain dead.  Why not go ahead and procure those organs?  And, you know, a very, you know, cogent argument was made for that.

You know I can remember an instance several years ago when I was a resident, New Year's Eve when a very prominent lawyer in the Baltimore area was involved in a motor vehicle accident and became a C-1 quadriplegic.  And he still had full retention of his mental faculties and requested that life support be withdrawn.

And the question comes up could a person like that who has full retention of their mental faculties also request that their organs be donated?  And I think that is a very legitimate question.

There was a footnote that mentioned that possibility but there was really no discussion in this paper but I think that is something that is worth discussion because we are looking at the ends.

And in the end, his request was granted after a great deal of ethical discussions with everybody on the face of the Earth.  But if he is allowed to die, why wouldn't he be allowed to allow his organs to be gathered?  And this is not something that I can see that has been discussed in a very important way.

The whole idea of the rights of the family enters this and really makes it complex because — and I certainly have been in this situation where you have to give, you know, bad information, bad news to a family.  And then in the next breath, you know, ask them for organs.  That is a very, very difficult thing to do.

And, you know, if we can come up with — if anybody could come up with a way to make that easier, it would obviously help the situation.  A lot of times rather than go through that, medical professionals simply don't ask for the organs because it puts them into such an uncomfortable position.  And I can certainly understand that.

So the bottom line in looking through all this is we have to ask ourselves the question how do we get the organs without violating our moral sensibilities and, you know, that is the crux of this entire compilation.  And hopefully what we will discuss.

CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Carson.

Dr. Meilaender?

PROF. MEILAENDER:Well, I also agree that it is a very nicely done paper.  It gives us a certain sense of historical development of how we got to where we are in these discussions now.  And it is thorough and thoughtful.

And, in fact, I couldn't quite decide what sort of comments from me would be most useful as a way to begin the deliberations.   So I want to do a couple things.

First, I want to point out — and, I mean, this is in the paper — it's not something original with me, but I just want to point out why we might be tempted to punt on this issue.  I think there is a temptation there.

I'm not sure I think we should punt on it but I just thought it would be useful to highlight this fact that the paper itself has.  And then after that, I'll mention just a few — three theses that seem to me to be truths to which we should adhere, however we go along, though they may not seem to truths to you.  You will have to see whether that is the case or not.

But first why we might be tempted just to sort of take a pass on this.  I think what the staff paper very nicely shows is that we find ourselves right now in a situation characterized in this way.

One the one hand, the issue of brain death as a theoretical question is by no means settled.  It turns out to be more unsettled than people had thought or liked to think for a while.  So it is a very much a live question with the problem under dispute.

And on the other hand, brain death, the notion of brain death has come to be rather generally accepted in our law and in our practice, even if people in every day life don't always think in those terms, but nevertheless in our practice we have accepted it.

And it is that fairly settled practice that allows organ transplantation to proceed if not perfectly or in the numbers that some would wish, at least relatively undisturbed.

And to push on the theoretical question is to disturb that relatively settled practice.  I mean I think the paper did a nice job of showing that.  We could reach conclusions if we really think it through that are fairly unsettling for our current practice.

We could, for example, decide that the current practice of declaring death on the basis of neurological criteria is incoherent and mistaken, which would throw an enormous monkeywrench into our current practice of transplantation.

Or we could decide that a person who has irreversibly lost simply higher brain capacities, as they are called, was dead, which would alter current practice in a very different and equally unsettling direction.

So when you think about those possibilities, we might just be tempted to let sleeping theoretical dogs lie.  And not do anything.  And that may be — I mean I don't know, we'll have to see.  That may be what we decide to do.

As I thought about it though, it seemed to me that in some ways the temptation to do that probably needs to be resisted.  At least one shouldn't give in to it too quickly.  And there may be short of, as it were, resolving the issue, which I suspect is beyond us, there may be some things that — some sorts of contributions that we can make.

And the first thing, it seems to me, is that we can take the critique of the current use of neurological criteria, we can take that critique seriously.

I think there is nothing more frustrating for people than to make a really serious case, to have serious claims, to have others acknowledge that these are serious claims, and then to have those others just keep on proceeding the way they have been doing as if, you know, you just wasted your time talking.

I do think that this is a serious critique made by serious people.  And at the very least, we owe it attention and not just to punt on it.

Another thing we could do, I mean perhaps we could — it might be useful just to make clear that at best, we are simply looking for a criteria for when someone is dead.  We're not trying to solve the deeply metaphysical question of exactly how we define it.  We talk about definition here a lot of times but maybe the more modest notion of just finding criteria for when that once animated body is no longer moved by its anima would be a sufficient thing to do.

We could — another thing we could do if we thought it possible although again this may be beyond us — we could try to offer a better account and defense of the current fairly settled practice if we think that neurological criteria are persuasive.

The staff paper has a nice account of the somewhat different British approach.  We could think about that possibility for instance so that could be done.  Or we could offer several alternative approaches just trying to advance the discussion.

But my tendency, at any rate, is to think that it is both deeply tempting to just bypass this question but probably not what we should do.  So that's sort of the first thing that I say.

And then the other thing is that just in thinking through where the argument takes us, what the staff paper had to say, it does seem to me that there are three things that I would hope we affirm, whatever sort of impenetrable difficulties we may encounter, whatever incoherences in our current practice we cannot fully solve.

There may be more than these but I'll hold my relative certainties here to three that I'll mention although as I say, they may not be certainties for you.

The first one in my own mind is that I think it is important to know when someone is still alive and when someone is dead — to have criteria that mark that out for all of us however difficult it may be to find the right way to do that.

However true it may be to say that in some context anyway that in a certain sense we all die by degrees, however much our individualistic tendencies might tempt us just to invite everybody to decide for themselves when they should be considered dead.

I think we should want to know when another human being is no longer a living human being.  We should know this, in part, because so long as they are still living, they have a claim on us in certain ways for the rights and respects that we owe other living human beings.  And also because when they are dead, they actually still have claims on us of a different sort for taking leave and burial and so forth.

So I'm not very drawn to what the staff paper describes as the new pragmatism approach to these questions.  I, myself, do not find that very persuasive.

The second thing I'd say is that it seems to me unwise to forget that whatever else we may be, we are also animals.  That is to say we share a kinship with the other animals and death, for us, must bear some similarity to what death for them means.

And I am, therefore, not drawn at all to the higher brain criteria for death which focus only on those capacities which we may not share with the other animals.  If you have lost — thank you, I appreciate that.  It's always nice to get affirmation from wherever it comes.

If you have lost a higher brain capacity but you are still breathing independently of mechanical assistance and your heart is beating, then yours is, as far as I'm concerned, still an animated body with the anima still present.  That would be my view.

And then the third thing, a slightly different point, I think we shouldn't lose sight of the fact that among the things this staff paper takes up, there are some important questions that aren't just questions about sort of deciding when somebody is dead or dead enough for transplantation to take place.

And in particular, and I don't know that all of you will share my relative certainties on this, but with respect to that newly reemerging emphasis on donation after cardiac death that we talked a little bit about last time, in fact, with the Institute of Medicine Report, to me there is a different kind of issue that really one shouldn't just let get buried here.

I mean I don't doubt that these people from whom organs are taken after they are declared dead are dead.  I mean there is that tricky issue about permanence and irreversibility and so forth.  And I don't say there are no complications.

But I don't doubt that they are dead but I do wonder whether we may teach ourselves to come to think of their dying as just a technicality that must be dealt with — kind of get past in order to get their organs that we need.  And whether or not it is dehumanizing in some ways to orchestrate death with that purpose in mind.

One of the primary moving factors that got sort of a bioethics movement off the ground in this country, you know, 30 or 40 years ago was the sense that medicine had sometimes so imposed its technical capacities on dying that the human meaning of one's death was lost.

And it would be a shame if we backtracked and lost that important insight it seems to me.  So that's a different kind of issue but I think it also warrants our consideration and attention.

CHAIRMAN PELLEGRINO:  Thank you very much.  Now open for general discussion.

Dr. Gómez-Lobo?

DR. GÓMEZ-LOBO:  Well, actually it is the case that I share most of Gil's relative or new certainties.  But I'd like to contribute to the discussion initially from a slightly different perspective.  In other words, I would like to make first a conceptual point and then talk about a general ethical principle.

The conceptual or analytical point is that in looking at the history of the discussion of brain death and all that, I see that there is a lot of confusion about what is being done.  I don't mean that this is going on in the paper.  I found the paper extremely lucid in this regard.

What I mean by that is the following.  It is more or less common to talk about a new definition of death and that is something that appears over and over again.  And I think that helps to confuse the issue because I really doubt that that is a correct way to view it.

To define a term "death" is to give the meaning of the term.  And if we give a new definition, we are giving a new meaning.  We are talking about something different.  Now that certainly I find unconvincing because in order for us to have a discussion, we have to have a settled meaning.  We have to be talking about the same thing.

So my first point would be that to insist that there is a stable definition of the everyday term "death."  And I agree with Gil that however it is explained, the meaning of death, it has to match at least mammalian animals and beyond.  In other words, death — when we talk about death, we talk about something that happens not just to humans but to other living beings.  So that would be my first point.  I would insist on that.

The reason why sometimes the confusion arises is because we do use the verb to define in the sense of to draw a boundary.  And, of course, what is being attempted in these discussions often times it is to draw a boundary.  And in that sense, it is not incorrect.

But it is not the same to define criteria, i.e., to determine criteria as to define what death means.  Now that said, I would insist on the notion that death is a negative term.  It is what is called traditionally a privation.  And Aristotle would call it a steresis, which means that there is, so to speak, no nature of death.  Just as blindness has to be defined by reference to sight, there is no nature of blindness.  It is just the loss or lack of sight.  Likewise, it seems to me, the common sense understanding of death is the loss or cessation of life.

And just for the fun of it, even such an authority as our very own Leon, actually because of that makes a slip in his comments, for instance — and this is actually in praise of him — he says the orthodox defense insists on offering the conceptual definition of death as "integrated function of the organism as a whole."

Now, of course, that's not death.  That is life.  That is an integrated functioning of the organism as a whole.  So the deep philosophical question then becomes what is the deep underlying essence of life and not the definition of death.

Now that brings us, of course, into very complicated issues and I agree that it may not — we may not need to go into it as a Council or even as a country because what really matters are the criteria.  Now we have to have some understanding of the life of an organism to even come to settle on criteria.  To say if these conditions hold, then the organism is alive.  If they no longer hold, if they are lost, if something has ceased to be, then we know or we have criteria to determine that.

In Capron and Kass's original article, I think this overlaps with what they call general physiological standards and criteria or operational criteria.  I think that the two can more or less be taken together.

And then, of course, comes the further element of the tests and procedures to determine whether the criteria have been met.  But to speak of criteria is not to speak about a definition.  It is to speak about the considerations that should enter into the question of whether a given definition previously has been met or not met.

So that is sort of the overall proposal in terms of conceptual clarification.  And that is why I like the Institute of Medicine proposal and the paper also does this is talking about neurological criteria or cardiac criteria — not cardiac — I'm sorry, not a new definition of death.

I don't think that brain death defines anything.   It just provides a criteria.  But even brain death is, in itself, a philosophically questionable concept.

Now, of course, this can be further refined.  And I think that in a report on the Council, it should be refined and spelled out.  I think that just clarifying the terminology of cloning was an important contribution of this Council made in our first report.

Now the second point I want to make is not a point in concepts but rather a point in ethics.  And it is that it seems to me that the dead donor rule should not be abandoned.  We've heard proposals to abandon the idea that a person has to be dead in order for it to be legitimate to harvest organs from her.

In the original article, Capron and Kass were very clear on this.  That the need for organs and now the so-called crisis in the need for organs should not drive our criteria to determine when someone is dead.  On the contrary, I think we should insist on the idea that we have to rethink, perhaps reconsider the criteria, perhaps require more accurate tests to be able to see if someone satisfies the criteria.

But all this done independently of the further intention of harvesting organs.  That seems to me is very important.  And then, of course, there is this possibility of someone saying I want to donate organs.  My inclination would be say that is fine but only after life has ceased.

It seems to me that to go into a living body to extract organs is a major ethical trespassing into the goods of human beings.  Thank you.

CHAIRMAN PELLEGRINO:  Thank you very much.  Anybody else?

Dr. Eberstadt?

DR. EBERSTADT:  I'd like to begin by saluting the staff for a fine paper which introduces us to a very important and also very complicated issue and one, I agree, that we should not turn our eyes away from.

I have four initial reactions or initial thoughts to offer my colleagues.  First, simply to state the obvious, there is an intense, and I think we can expect increasing pressure for what to paraphrase Daniel Patrick Moynihan we might call "defining death down."

And this pressure comes not only from the demands and realities of the circumstances for the organ donors but also from the increasing medical expenditures which attend our economy with end-of-life issues.  I think that we will see this economic pressure continue to grow.  That does not mean that we accede to that pressure but simply that we recognize it.

Secondly, for that very same set of basic economic reasons, I think that we can expect to see increasing material pressures to conflate questions of death and viability.  And some of those issues are mentioned in the paper I think very well.  This is, again, something that I think we must be very careful to separate the questions of death and viability.

Third, I agree with Gil that we should not proceed as if death is a matter of taste.  It is a universal human experience and condition.  It should be recognized as such.  And thus, I think there probably should be universal human death — an issuance of phenomenon.

Fourth, Leon Kass is not here but in the paper that he provided us with, he mentioned one thing in particular that I think might be apposite to add to our discussion.  And that's the discussion of the human soul.

Leon mentioned in his paper that if you asked most people in this country or others — uninformed, non-medical specialists, they would describe death as the point at which the human soul or human spirit departs from the body.

And, I don't think that that is specific to the traditions of — what would we call that — the Abrahamic faiths, Judaism, Christianity, Islam.  I think one would find that also in Hindu tradition, in parts of the Buddhist tradition, in many of the animist traditions around the world.

Being — and I think that that whole question of the human soul is one that we would be — it is very difficult to integrate into our discussions today but it is also one that we might also wish to be mindful of.

CHAIRMAN PELLEGRINO:  Dr. Carson and then Dr. Lawler.

DR. CARSON:  One thing that, you know, becomes apparent in looking over all of this history and attempts to define death is that, you know, in the time before we had the ability to intervene with all of our technological advances, it was a fairly simple thing to know when somebody was dead.

And I suspect as we move further into the future, the definitions that we come up with today are going to, you know, fade into oblivion as well.  I mean there may well come a time when, you know, cloning becomes an accepted norm.  And then people say you are only dead when your cells can't be cloned any more.

I know it sounds strange to us today but that could well become the case.  So I think it is really sort of a moving scale that is largely based — or can largely be based on technology.  And I guess what I'm trying to say is you know we shouldn't allow ourselves to be propelled along, you know, that line of redefining things as technology comes along.

There should be a better sense.  And it really gets back to what you were saying, you know, about the soul or about that part of us that when gone, no longer allows you to function as a human being.  And, you know, maybe we need to be looking that way rather than at the things that are created by technology.

CHAIRMAN PELLEGRINO:  Thank you very much.

Dr. Lawler?

PROF. LAWLER:  I agree with the consensus that death is something real.  This post modern thing doesn't work with death.  You can put soul in quotes.  You can put truth in quotes.  But you really can't put death in quotes.  Like some people say he is "dead."

In fact, we are pretty sure that many, many people are dead.  It is not really a matter of an opinion.  And the death we die is real.  And it is the death of an animal.

Ben is correct to say there is something creepy about technology because it used to be death was less controversial.  We knew who was dead.  We didn't have to give it much thought.  But now with ventilators, we are not so sure because we have made discoveries we wouldn't have made had it not been for the existence of technology.

So human death has become different from dog death for this reason.  Even in an era of pet cemeteries and all that, we're not putting dogs on ventilators.  So we're not going to make the same sort of discoveries, I hope, when it comes say to our pets.

So we have this ambiguity.  The argument for brain death was without a brain, you can't function as a whole.  But it turns out due to the ventilator, we have discovered that you can, at least to some extent.

So the organism can be a whole and in a certain way from the traditional point of view, without a soul in a way, in a controversial way, because the organism then becomes no brain and all body.  And it keeps going.  It keeps ticking literally.  So this presents us with a problem.

The brain death definition, which we thought was true in a less uncontroversial way than we do now, was very convenient for the harvesting of — I don't like the word harvesting — for getting organs for transplant because it is easier to get the organs, obviously, if the heart is still ticking.  And if we abandon brain death, there is a pragmatic problem of we will have fewer organs.

So we are kind of stuck — we have Gil's let sleeping dogs lie issue comes up in this way.  We can either abandon brain death in light of the new evidence that is pretty persuasive in the great paper or we can absorb the new evidence and succumb to the temptation of taking organs from beings who we don't really think are dead in the full sense.

And that would be a fatal compromise, a succumbing to the new pragmatism actually to take vital organs from beings who aren't dead.  So A, we compromise death; or B, we have fewer organs.

Now when the libertarian Professor Epstein was here, he said Reason No. 906 I am for organ markets is you will soon get so desperate without them that you will start to mess with death.  And unfortunately, the new evidence presented by the great report suggests that if we stay with brain death, and we look at the facts, this is, to some extent, messing with death a little.  We are keeping the status quo while ignoring the new troubling evidence about, you know, the fact the human being is not as brainocentric as we thought the human being was.

So what do we do about this?  This is not so clear to me what we do about this.  Leon Kass in the memo he sent us thinks we should work harder in defending brain death.

And he does it in this way — that maybe we can define death as number one, the permanent cessation of spontaneous respiration.  The organism can never again breathe on its own or without the ventilator.  And permanent cessation of wakefulness without which an organism cannot perceive anything.

So any being who cannot breathe on his own and cannot be awake ever again is dead.  And all we have to do is come up with the neurological criteria that shows us when this being is in this situation of not being able to breathe again and not being able to be awake again.

The trouble is we are stuck with this.  The heart is still beating and the organism keeps on ticking.  And now we know this.  So what do we do?

It's not that clear to me what we do given that brain death is more controversial than it used to be except to say if we abandon the standard of brain death, the result will be fewer organs acquired and the pressure will be greater then to engage in organ markets and such because it will look really perverse if we A, come out against organ markets and number two, make it harder say to get cadaver organs of one kind or another.

So there is a strong argument for letting sleeping dogs lie but unfortunately, we know sleeping dogs, due to the great report and the recent studies, we know sleeping dogs are sleeping dogs.

So I'm against the new pragmatism that dumbs death down and makes death a matter of opinion.  Death, as everyone knows — I'm not an M.D. but I think people know death is not a matter of opinion.  Each human being cannot define death for him or herself in any strong way.

On the other hand, I'm not so against the technological orchestration of death in order to maximize the number of organs we can get.  I think getting organs for transplant is a great human good.  And we should knock ourselves out to get as many as possible without compromising death.  So I am a bit confused on this.


Dr. Meilaender?

PROF. MEILAENDER:I note for Peter that some people have tried to clone their pets.  I don't know about the ventilators yet but you just might keep that in mind.

I find myself in the, for me, unusual position of wanting to issue a caution with respect to language that is often thought of as religious.  That is to say the soul language though, of course, it doesn't have to be necessarily religious language.  It can be sort of a purely philosophical language.

But I was sitting here when Ben was talking, thinking about the danger of this language is that people are going to connect soul language to certain kinds of higher brain capacities.  And think that the loss of the soul is the same as that.

And then sure enough, five minutes later, Peter talked about a functioning body from which the soul or the brain is gone.  I think that is a mistake.  And I don't think that is the way the soul language needs to be understood.  I just want to point out that it is a danger.

From my perspective, any proper understanding of soul language is such that if you got a living human body, there is a soul there, you see, and you actually don't know that the soul is gone unless and until you don't have a living human body by whatever criteria you determine that any longer.  If it is animated, the anima is there.

And I thought it might be useful — I mean I don't know but just a certain kind of illustration — we tend commonly, those of us who use soul body language at all, and, of course, there are people who don't, but those who do tend commonly to think of it sort of like these two things temporarily join together, which then could be separated and maybe could be reunited or something like that.  Sort of like a rider mounted on a horse.

And that image won't work because it is as if you could shoot the horse out from under and leave the rider perfectly unscathed.  Or as if you could kill the rider and just have an animal left or something like that.  Whatever exactly this language means, you have to think of it more like a centaur.  You see the union of man and horse in such a way that you couldn't just kind of shoot the horse out from under and everything stays the same.

And if you think of it that way, then we will have less inclination to connect soul language with those peculiarly higher capacities of the brain.  And I don't think anybody ever really made that connection prior to about the 18th century, in fact.

But I obviously don't really have a problem with the language.  I just think that it can lead in some directions that, from my perspective, are unfortunate, actually, here.  And so we need to be cautious about how we use it.  And careful.

CHAIRMAN PELLEGRINO:  Thank you very much.

Dr. Bloom?

DR. BLOOM:  Well, perhaps I am the only one who feels this way but I do not accept the scientific arguments put forward that challenge the concept of brain death.  It seems to me that the definition on page 18 of the text defined by Dr. Pallis holds.  And until I hear an argument to the contrary, I see no reason to have this loss of confidence in the brain death definition.

PROF. MEILAENDER:Can you say a little —


PROF. MEILAENDER:—  more about what you see as the defects of the challenge rather than just affirming the Pallis —

DR. BLOOM:  Well, the fact that the heart will continue to beat without the brain does not, in itself, constitute life as we know it.  The fact that the guts will continue to digest food and that the liver will continue to metabolize carbohydrates and fat is not life as we know it.  It is cellular metabolism.  But it is not human life.

The fact that the body cannot respond to the lack of oxygen and initiate breathing combined with the loss of consciousness represents to me a dead person.

The last argument that Dr. Shewmon made, which is that vasopressin, an antidiuretic hormone, can be secreted is not much different than the body reacting to hypoxia to try to initiate breathing.  When the salt and water balance of the body are effected, a nonconscious hormonal reflex causes vasopressin to be secreted.  That does not represent human life.

So I did not find Dr. Shewmon's word game with a variety of concepts of integration of the whole to be a convincing argument against this very simple and straightforward definition: the lack of consciousness combined with the lack of ability to generate spontaneous breathing is death.

DR. FOSTER:  Along the same lines just quickly, I mean we take cells out of bodies all the time that metabolize carbohydrates and fats and make lactic acid.  They do every single thing that the arguments were used against this.  They just don't hold I don't think.  I'm just agreeing with Floyd's assessment here.


PROF. SCHAUB:  Ben Carson gave me my opening by saying that in the past death was more clear cut.  I have two passages from long ago that I want to throw into the mix.  One is from George Washington.  George Washington, on his deathbed, gave the following last orders: "Have me decently buried and do not let my body be put into the vault in less than three days after I am dead.  Do you understand me?"

Apparently he feared being buried alive.  So it has long been understood that life can imitate death.

Edgar Allen Poe, the other passage that I want to toss in, is the master of telling about the horrors of being buried alive.  I just have one paragraph from a story called "The Premature Burial."

To be buried while alive is beyond question the most horrific of these extremes which has ever fallen to the lot of near mortality.  That it has frequently, very frequently so fallen will scarcely be denied by those who think the boundaries which divide life from death are, at best, shadowy and vague.  Who shall say where the one ends and where the other begins?  We know that there are diseases in which occur total cessations of all the apparent functions of vitality and yet in which these cessations are merely suspensions, properly so called.   They are only temporary pauses in the incomprehensible mechanism.  A certain period elapses and some unseen mysterious principle again sets in motion the magic pinions and the wizard wheels.  The silver cord was not forever loosed nor the golden bowl irreparably broken.  But where meantime was the soul?

So, I mean it seems that in the past, it was a matter of waiting long enough to be sure that the vital principle was extinguished and not just in abeyance.  But now the push is entirely in the other direction.  We want to speed up the determination of death — speed it up as much as we can.

And it does seem to me that there is something unseemly about that push to speed up the determination of death.  And so I guess I would be in the favor of erring on the side of life and pursue rather conservative policies, certainly sticking to the dead donor rule and setting very stringent criteria for death.

The Shewmon article, one thing that it points out other than this issue that Dr. Bloom just raised, but the Shewmon article points out that the current criteria don't fully match the whole brain death definition.  And so it seems that there might be work in sort of refining the criteria.

I did also just have a question about the comparison between the U.K. standard and the United States standard.  And I take it, Floyd, that you were embracing the U.K. standard.

Can somebody explain a little more clearly to me what the differences would be?  I mean it did seem as if the U.K. standard would somewhat expand the class of people classified as dead in comparison to the United States standard.  Is that correct?

CHAIRMAN PELLEGRINO:  Alan, would you clarify that issue for us?

MR. RUBENSTEIN:  I'll do my best.

The clinical bedside tests that are performed to determine if a person is brain dead test brainstem functions.  So it tests brainstem reflexes, it tests for apnea, inability to breathe on their own when the ventilator is removed.  There is also other tests which are not called clinical tests: lab tests or something else which involve EEGs or testing for intracranial blood flow.

Those tests aren't done in Great Britain.  If a person meets the clinical tests for brain death, then that is sufficient.  So theoretically, there could be someone who, in the United States, is not classified as brain dead because something comes up on the EEG or something comes up in one of these other tests that shows that although from the brainstem perspective, they are completely gone, from the whole brain perspective, they are not completely gone.

My impression from the literature and someone should correct me is that it is very rare that someone who would be considered dead in the U.K. — in the class of brain dead — would not be considered so in the United States.

There was a significant stir in the literature when it was discovered that there is still this ADH secretion going on in some brain dead patients which is a secretion of a hormone which pretty conclusively shows there is something going on in the brain although the person has passed all of the tests for brainstem death.

So, again, how to interpret what that means is a little bit unclear.  But for the British standard, and this is actually said by Christopher Pallis in papers, he said well, that is just not a problem for us.  So there might be a little bit of continued activity in the brain demonstrated here but we were only ever concerned about the brainstem anyway.

So it kind of shows you where there is conceptually, at least, a difference.


Dr. Schaub, did you want to comment?  Dr. Hurlbut?

DR. HURLBUT:  It seems to me that if we do enter this realm of discourse on the definition of death, we are dealing with a lot more here than just the questions associated with organ donation.  We are dealing with a realm where a lot of strange and perhaps even ghoulish concerns may arise.  And yet a lot of positive possibilities that would allow good advance of science.

And I am thinking here of the — it's not a large-scale phenomenon but there are some new inquiries into physiological functioning on otherwise dead or dying bodies.  And there would be scientific value in doing some physiological studies on a respirator-sustained corpse, if you will.

I think also there are going to eventually be some very strange questions about the borders of organ versus organism as we start to develop technologies to produce organs and maybe even organ systems apart from the body as a whole.  Who knows whether these will turn out to be feasible but my guess is that they will.

When you talk with people who are working with — in stem cell research, they speak optimistically about being able to identify those combinations of cells independently produced when put together spontaneously generate portions of organs and perhaps even whole organs.

That seems to me to be a physical phenomenon that we could eventually study and master.  And, by the way, that has nothing to do with having to sacrifice embryos to get those cells.  You could perhaps get that whole scientific progress in place without ever going through an embryo.

So the point is that eventually we may have some very strange questions coming that cause us to want to know what is the definition of life, organism and human organism.  And we would do a service to the society to initiate the discussion on this because these are going to be very difficult issues.

It is clear that having used a very productive heuristic of a body-mind dualism, that now it is starting to cost us.  And it is time to reexamine the meaning of embodiment.  And if we don't do it now, then it will eventually fall to others.

But it is such an advantage to doing things before you are under the pressure of the politics and the pressure of the pragmatic possibilities.   There is a bit of theoretical distance that we have an advantage of from the present.  So that is the first thing.

Oh, by the way, another interesting border and boundary of humanity question that would be somewhat at least tangentially relevant and implicitly covered in this kind of discussion would be the question of human-animal chimeras which, I'm going to say tomorrow, I think is a subject we ought to address that Diana has done some very good thinking on that.

But the single thing I think we could gain by entering this inquiry, and this is a little bit broader than just what we are talking about right now, but it is clear that there is the fundamental question of the protection of human life.

But it would be a helpful contribution to our culture if we would clarify and define the secondary moral and prudential concerns associated with it.  And draw a distinction between the absolute protection of life and the violation of human dignity and the sensitivity of human process.

I'm thinking here of the more — the issues of semiotics, that kind of symbolic significance of the body and the personal feelings that attend.  We obviously have natural moral sentiments that are shorthand for large questions.  They function for us but they are not exactly scientific categories.

I guess what I'm really trying to say here just to sum it up is that in trying so hard to stay away from the word "soul," which we have done diligently in this Council, reflecting on how we avoided that terms when we were talking about cloning took some dancing but we did it, but trying to avoid the word soul, we have lost the functional shorthand for what a lot of people — what relates to a lot of people's concepts of what is going on in these realms.

If we could in a gingerly sort of way reenter into that category without any disposition of prejudice toward any one formulation, we might really come to some valuable insight and help our society reformulate what was meant by soul but in a more pluralistic and more material physiologically-related description.

In other words, I think we might be offered the unique opportunity to clarify the meaning of soul and psyche in modern terms would be a really wonderful thing to do because there is a lot that is being lost by not using the word soul.


Dr. Lawler?

PROF. LAWLER:  That would be a big job for us but a good job perhaps.

I raised my hand a while ago to say I agreed with Gil that I don't — you know you can't talk about the human soul in the absence of a human body as if the soul and the body weren't a whole.  Now you can call the whole the soul because the danger in talking about the soul as if it were something different from the body is you might end up distinguishing between human life and life.

So human life is worth legal protection but not life.  And so you can conceive of the possibility of something that is alive, a being who is alive but is not human.  And the studies before us present us with this possibility.  I mean a real possibility of this being who is somehow still an organism but without a brain.  So is this a human life?  A being that is somehow still an organism but utterly without a brain?

But I think it is dangerous, horrible to distinguish between human life and life for reasons we have all talked about in different ways.  So — right, so I would be — if we can show that this being — and I agree with some of the doubts that have been expressed.  I'm very unsettled on this.  I've just learned about these studies lately.

That this being who has a beating heart and is in some way an integrated organism but really doesn't have a brain, if we can show this being is alive, I would agree with Gil.  This being has a soul and we should call it a human being.  And so worthy of legal protection.  But I think the jury is out on this for now.

Now Diana is right that we do rush to judgment now when it comes to death.  And there is something utterly unseemly about this.  So you might want to say that the only way to avoid this is to completely detach our understanding of life and death from any consideration concerning the donation of organs, the acquisition of organs.

Now the problem with this is that would diminish the number of organs we get or acquire that will benefit others.  So there is a kind of understandable pragmatism here.  We don't want to do the wrong thing — that is take organs from living human beings.

On the other hand, we want to get as many organs as we can.  And so we are kind of stuck with this rush to judgment with respect to death.  We need to know exactly what death is more than ever because we can't afford to wait around if we regard acquiring organs as a human good.  So we need to know what death is more precisely than ever now.  And because of the ventilator, we are less sure than ever what death is now.

So — and I'm scared if Bill is right and the line between life and non-life is going to get fuzzy on us.  Because, in fact, life is already mysterious enough.  We really don't understand where animation comes from or how something suddenly gets animated.  Why in a lifeless universe did life emerge?  Now we don't understand that and that causes problems.

But if it turns out there is categories that aren't clearly in life or non-life, then our whole moral system explodes on us sort of.

CHAIRMAN PELLEGRINO:  Thank you very much, Peter.

Dr. Carson?

DR. CARSON:  You know the surgeon in me says, you know, if somebody is irreversibly injured, they are not going to come back to a functional state and if somebody else who could use their organs, we should take the organ and give it to the one that can stop going through all this silliness.

But I recognize that I'm not speaking as a surgeon today.  I'm speaking as a member of the President's Council on Bioethics.  So, you know, let's go back and hash this out a little bit, you know, in terms of living versus not living, being human versus being not human.

You know we all remember back in high school in our biology classes that we took the heart out of a frog and put it in a vat of lactated Ringer's [solution] and it continued to beat.  Does that mean that frog is still alive?  Well, maybe you say it takes more than a heart so, you know, let's connect the liver and the intestines with it.  Maybe then it is alive.

I mean where do you stop, you know, when you start dealing with that kind of an argument.  And, you know, I have to agree with Dr. Bloom.  You know the brain really is the thing that distinguishes from a mass of cells.  It is the thing that makes us into human beings, that makes each person.

And getting back to what Gil was saying, it is also what makes an animal into, you know, an individual animal.  And if you take a dog's brain out, you have got the same situation.  A mass of cells, a mass of organs, but, you know, does it matter if they are inside the cavity of a body versus in a petri dish?


PROF. MEILAENDER:I am coming back to Floyd's comment just to note one thing.

I would be very happy — and his comment seconded by Dan actually — I would be very happy if it turned out that we thought we could come up with a good defense of something like the current understanding of not so much definition of death but criteria for determining death.  I mean that would solve a lot of problems.

My only concern back from my opening comments is that we not, as it were, just pretend that there hadn't been a serious challenge mounted to it.  Now you didn't seem to want to take it seriously and maybe if I knew as much as you I wouldn't either, I don't know.   But I do want to try to take the challenge seriously.

One way to take a challenge seriously, of  course, is to reject it finally.  And that would be possible.  The one thing I wanted to notice in — if, you know, we think this through and turn in that direction is that there is something I'm not clear on with this British definition which does have the sort of admiral quality of sort of simplicity to it, the loss of the capacity for consciousness and the loss of the capacity to breathe.

I just would notice that that formulation from the paper is a little different — a little different from the way Leon reformulated it in the comments he left with us because he put it in terms of the loss of the capacity for respiration or spontaneous respiration and permanent cessation of wakefulness.

Wakefulness and consciousness are not precisely the same.  Now it may be that given that you have got the coordinating conjunction combining that with spontaneous respiration, it may be that practically speaking they would come to the same thing.  But that is, I think, something that would have to be sorted through in thinking about this.

I do not think that a capacity for consciousness and a capacity for wakefulness come to the same thing since, as I understand it, and it is subject to being corrected by more knowledgeable people, the PVS patient, for instance, is a classic case of someone who has permanently lost all awareness but has periods of wakefulness.

So one would need a certain kind of just clarity about how we formulated that.  And I don't know, it may not be accidental.  But Leon's formulation was a little different.  And maybe it is entirely accidental.  I don't know.


Dr. Bloom?

DR. BLOOM:  Well, the reason I prefer the Pallis definition to Leon's is that I could imagine a state like REM sleep in which one would have conscious awareness of past memories but could not wake up.  But loss of consciousness requires being awake.  Consciousness requires being awake.  I misspoke.

PARTICIPANT:  I was trying to figure that one out.

DR. BLOOM:  Yes, sorry.

PARTICIPANT:  You had us for a minute there.

DR. BLOOM:  So to me, the original Pallis definition seems to me to be more coherent and consistent with what a physician would want to find to declare that person dead: loss of consciousness combined with the inability to generate spontaneous respiration.


Dr. Schneider?  Then Dr. Foster.

PROF. SCHNEIDER:  I just have a few thoughts that I feel obliged to reveal to the world.

The first is that we have been talking as though almost everything about the definition of death is ultimately being driven by our desire to transplant more organs.  And I certainly agree that historically that has been one of the things that has moved changes in the definition along.

But I think that the other thing that has been very powerful that way has to do with something that is a much more frequently occurring kind of problem.  I mean very few organs are transplanted but people worry about when someone is dead all the time.

Millions and millions of people die with concerns about at what point the relatives and the physicians and possibly the patient decide that human life in some meaningful sense is no longer present.

And I think that an awful lot of what drives the ordinary person's feelings about the definition of death have to do with a sense of the absence of the things that were important about the person at some physiological point.

And that leads me to my second kind of concern which is that I think that a large part of the problems that we saw, for example, around the Schiavo case grew out of the fact that understandings about when we are going to treat people as dead are very different in professional communities and in the rest of society.

We have allowed these changes in understandings to take place differentially in a way that leaves the ordinary person completely aghast when they discover the way that professionals, lawyers, ethicists, doctors think about these things.

And I think that there is a significant social cost to pay when you have a disjuncture between professional thought and the thought of the human beings who are actually involved in these cases.

And that leads me to my third point which is a point I make as a lawyer.  Whatever you do, it is very important to produce definitions that people can understand.  Even the brain death definition has not been understood by substantial proportions of the medical community.

There was an interesting study by Youngner and a colleague or two that suggested that physicians and nurses widely misunderstand what brain death as ordinarily understood is supposed to be.

So my plea here is that whatever definition one might think it wise to come up with, it, as a practical matter, has to be a definition that people can understand and apply in some reasonably comprehensive, comprehending way.

Thank you.


Dr. Foster?

DR. FOSTER:  The late Richard Feynman, the great physicist who won the Nobel prize, had a famous statement which said that we ought not to tell nature what to do but we ought to listen to nature.  And I just want to make a brief comment teleologically in support of Ben and Floyd's primacy of the brain.

If the blood pressure falls, then the body does something very interesting.  It stops — it doesn't stop completely but it shunts blood away from the liver and the kidney in order to preserve it for the brain.  In other words, it will say I will let the kidney die and I will let the liver die if I can protect the brain.

Along the same lines, in starvation, for example, the liver stops making many proteins but it doesn't stop albumen because albumen is what sustains the volume of blood to protect the brain.  In other words, the body teleologically says it will do everything to protect the brain at the expense of other things, kidneys and so forth, it will sacrifice them.

So we talk about many times the multi-organ failure.  Much of that is done to protect the brain.  I mean if you just listen to nature without all the philosophical arguments at all, it will tell you that in all animals and in humans, the prime event teleologically is to protect the brain.

And so I'm just saying this in simple terms that I think everybody would understand.  If you can't breathe, then you can't do it.  That's brain death.  And so I'm not —

And there are many reflexes — I don't want to be ghoulish but the antidiuretic hormone which is meant to preserve water it also sustains the blood pressure.  So any time the blood pressure falls, you are going to release antidiuretic hormone automatically.  There are cells that contract in all sorts of ways to do this.  It's nothing funny.

Many times, you might argue, just because people — that there is a release of stool or urine at the last thing, that's not because the GI tract or the bladder are still alive, they are just contracting in terms of a reflex thing.

So I think we ought to listen to nature about what's — and that is sort of silly to talk about that because everything is important for life, I mean, but nevertheless in life, the body tries to sustain the brain above all things.

So I think that the idea of focusing on the brain is a perfectly scientifically correct way to do — I'm not saying it is the only thing that counts but nevertheless that is what Feynman would say: listen to nature and it will tell you what's most important.

CHAIRMAN PELLEGRINO:   Thank you, Dr. Foster.

Further comments?  Questions?  I saw Dr. Lawler and Dr. Hurlbut.

PROF. LAWLER:  Okay, in my confused thinking on this, I notice that all the M.D.s are in agreement.  And so maybe we should listen to them in addition to nature.

PARTICIPANT:  That's always a good idea, listen to us, right?

PROF. LAWLER:  I don't do that when it comes to my personal health but with respect to these big issues maybe we should.

And, of course, as usual, Dan engaged in this self-deprecating irony about being philosophical as if it embarrasses him.  But listening to nature is philosophical.  So what you were saying — and I'm saying very tentatively is here is the opinion, so to speak, of the body.  We exist for the brain.  And so mainly we defend the brain.

If the brain ain't there, then we're pointless.  We have no business being around.  And so if we look to the teleology of the body, the body understands itself as mainly a defense mechanism for the brain.  Is that right?

DR. FOSTER:  It is very simplistic.  But I mean I was very simplistic, not you.  I was very simplistic.  But I think that yes, one should pay attention to what nature tells you.  That was Feynman's argument and that is the argument that I think all three of us are making here, yes.


DR. HURLBUT:  Well, this is just a little addition to what Dan said and continuing with what I said earlier.

I think Leon's distinction between brain death and death of a human being, there is something good in pursuing that distinction.  And in reading over the working paper and Shewmon's article, it struck me that Alan Shewmon has a lot of interesting stuff to say to us.  And yet I also had the feeling that if we took it and thought deeply collectively about it, we might actually be able to come up with something that preserved Leon's insight of what the death of the human being actually is.

And I'm not convinced we don't have the increasing insight into what is a reasonable physiological criteria for making those distinctions now.  I mean we have an increasing understanding of systems biology and a sensitivity to what relationship of the parts produces a whole.

And I mean I don't know it is at least worth exploring whether we might thoughtfully reconsider what defines a human life.  And take on this hard problem.  I mean at least we could look to see whether it was tractable or not.

That seems to be a very worthwhile thing to do.  If a body like ours isn't willing to do that working on the kinds of insights that Dan just said, then who would do it.  And we have a range of perspectives here that — and also recognize the pragmatic implications of this both for organ donation and beyond that there is something that feels very consistent with our mandate as a Council here.  This feels like the kind of issue we were meant to take on by our composition and original Executive Order what we were supposed to do — deal with these cutting-edge issues.  Well, that says it.

CHAIRMAN PELLEGRINO:  Thank you very much.

Dr. Meilaender?

PROF. MEILAENDER:Well, given that our numbers are a little smaller today and that we may be  close to exhausting our collective wisdom, I wonder — you may not want to but I wonder if you, as the Chairman, would have anything to say on this.

I would be interested to hear, if you are willing, given, you know, you have got years of clinical experience, you have watched the development of this argument over several decades.  Are you interested in commenting on it?  What angle would you take on it?

I personally would be interested to hear if you are — since there is nothing more for you to moderate right now, I would be interested to hear it.

CHAIRMAN PELLEGRINO:  Will somebody ask to speak so I don't have to?

No, thank you, Gil.  I have been following the general policy of not making many comments because I think the job of the chairman is to see that everybody else has an opportunity to speak.  And also, I have no claim on any special wisdom.  And many years of clinical experience does not necessarily make me an authority on this question.

Obviously you have been talking about a question which has been vexing us as clinicians for a long time.  And it is a question that I think will go on.  I doubt that we are going to be able to arrive at a definition everybody would agree to.

I do think we could perform a very useful function by laying out the issues in clear form as I think this Council has done in the past in its previous reports, which I think are exemplary in laying out the issue.

My own point of view: I am very, very leery of brain death criteria purely from the side of what are the consequences that may follow from them.  I know the arguments...

I think this and a lot of other questions in bioethics are extraordinarily difficult because we must act in the presence of uncertainty.  And I think that situation is going to persist for a long time.

So my own take, if I may say, Gil, is rather to look at the question as a bedside question, if you will, of how do I act in the most defensible, morally, ethically defensible way, when I have to make decisions that involve questions that have a lack of absolutely certainty.

Those of you who are clinicians know that

that is what we do all the time.  Clinical medicine is the science of probabilities, certainly not of certitudes.

I don't mean to preach here or to dodge the question but from my own point of view, I would still think in terms of the very, very old fashioned [criterion of] cessation of respiration and of circulation.  And without trying to defend that at the moment.  Just to respond to your question, Gil.

From the point of view of what the Council ought to do, I am inclined to agree with Bill Hurlbut that we ought to take a look at this question.  As I said, lay out the issues.  We may not be able to, if I [understand] your discussions, I doubt that we will come to a consensus in the true sense of that word.  But I do think we can add to the discussion the issues that you have brought up [to claim] the question if not the answer.

Well, without going on and on, Gil, my own feeling is to look at this as a clinical question (with all of the philosophical issues in the background) where we must act in some way and we must find out how do we can act with the most defensible position from the ethical point of view.

So, therefore, I think an ethical analysis of the lack of certitude and the question of how we act without knowing exactly what the answer is would be important.  I have myself, for my own thinking, come to look more in terms of the fact that there comes a time in the natural history of any disease when we have to decide that medicine has nothing more to offer.

.In many of the cases you are talking about, we could change the circumstances of the decision from the question of "is the patient dead?" to the question of "are we justified in continuing treatment?" because I do believe there is a [clinical] principle that says that if there is nothing to be achieved by what we are doing, we don't have a moral obligation to do it.

Without going into detail — I have talked to my colleagues about this — I think there is a way to get around some of these questions without getting to the ontological question of whether the patient is alive or dead.

From the ontological point of view, I believe that death occurs when the soul leaves the body.   I take the Aristolelean point of view on the soul and the unity of body and soul, as some of you [have already] said.  And I don't think we are going to be able to discern that moment by any test that I know.

So let me just close by saying that I think A., we need to act.  And, therefore, the question of what are the criteria that [constitute] a morally permissible act at this point given the uncertainties and the likelihood that those uncertainties are not going to be resolved.

The second question of perhaps looking at a decision-making process [in a different way] that doesn't say "is the patient alive or dead?"  But rather says, "are we justified in continuing treatment or have we not reached that point where ethically one may say we should allow the natural history of the disease to evolve?"  And is that natural history being impeded by the use of technology to no end and purpose?

Now there is a lot in that.  And I don't mean to convince you that that is the way to go.  But that is the kind of thinking I'm going through at the moment.

Yes, Peter?

PROF. LAWLER:  So I have to add our M.D.s don't exactly agree after all.  But more than that, you point to a problem.  The cases discussed in the paper, in every case, everyone would agree further treatment is pointless.  You can remove the ventilator.  In no case do we have anything controversial there.

What is controversial is sometimes you want to keep the person on the ventilator, not for the person's own good but to facilitate the acquisition of the organs.  Do you think this is morally defensible?

CHAIRMAN PELLEGRINO:  I think that if you have arrived at that point where you can say that we have reached the limits of anything that medicine can contribute — that is to say in the way of good or benefit to the patient — and where the burdens may overcome the good [according to] the principle of disproportion, under those circumstances you could say well, we are justified in removing the respirator.

Now having made that decision, I don't — I think it is defensible to say we can now have a controlled dying process.  That we can remove the respirator in such a way that with all the things that go with it, we can remove the organs [after the heart and breathing stop].  And you haven't had to ask the question is the patient dead?  You've decided you are going to allow the natural history to emerge.

I think that is another way of looking at it.  And personally when I'm doing ethics consults and so on, I lean in that direction.  I think that is defensible.

DR. GÓMEZ-LOBO:  This isn't a question what do we do by ignorance, of course, but isn't it the case that in order even to deliberate about removing say extraordinary means, you are asserting that the patient is, indeed, alive?

In other words, I side with Leon, I think, on this one that the question about end-of-life treatment is a different question conceptually speaking from the question of whether the patient is alive or no longer alive.

CHAIRMAN PELLEGRINO:  Well, I think you are right about that.  It is a different question.  But given that we cannot answer that question in the ontological sense (to speak philosophically about this), and we have a practical decision to be made, and we are in the realm of the bedside, clinical decision-making process, given those things, it seems to me that the approach that I have suggested doesn't have to answer the question "is he alive or dead?"

If you are saying "is he still alive?"  I'd say yes, that is right.  But let's take a situation that Dr. Carson faces, I suspect, quite a few times.  A young person riding a motorcycle, the death instrument, and hits a concrete abutment.  Now they keep him alive long enough to come to your attentioN

And then...someone... would say, "Well, there is so much damage here to the brain physiologically and pathologically and so on, to the best of my clinical judgment — and we are human and our clinical judgment is just that — we are assuming you are well qualified — this patient cannot recover."

And anything we do for this patient will be — I'm going to use a word that is very, very much debated — futile.  I'll define that if you want but, again, I'm not here to [defend this point].

Under those circumstances, that young man is living but [the clinical judgment is that] there is no future for him.  And in [the physician's] best judgment, that patient will die [no matter what we do medically] within a period of five or six hours let's say. 

And under those circumstances, we could discontinue treatment as being of no [medical] value to the patient.  Being perhaps, for many, many reasons, not beneficial [but burdensome disproportionately].  They are two different things — effectiveness and beneficial.  And then allow that patient to die.

And in the process, begin to prepare him for the taking of his organs.  That is the question.  . [H]e is alive, yes.  But we allow people to die [to permit] the natural history of that disease to express itself. 

DR. GÓMEZ-LOBO:  But Dr. Carson would not extract organs before the patient —


DR. GÓMEZ-LOBO:  Dr. Carson would not extract organs before the patient has died according to your criteria which are basically cardio-respiratory criteria, right?

CHAIRMAN PELLEGRINO:  Oh, yes.  Well, under those circumstances — I didn't go into all the details of what I would do under those circumstances.  You decide — you've got everything ready.  You've decided that this is the time to remove the respirator and the other support mechanisms [not to remove organs, but because the patient is dead].

Follow the electrocardiogram for three to five minutes.  If you get no sign of electrical activity, then you can say — you can say he is dead. [H]e is at the point where you can take the organs.

I think that is why I fall back on cardio [pulmonary criteria for death to be pronounced].        

DR. CARSON:  I was going to say what actually is done in that case because it does come up.  And what actually is done is we determine whether, in fact, the patient has any cerebral blood flow.  You know we would do an EEG.  We would do an apnea test.  And we'd talk to the family.

And if the family says, you know, they are willing to donate organs, that the team is called — the procurement team is called.  They take the patient to the operating room.  They procure the organs.  And that is standardly done.

CHAIRMAN PELLEGRINO:  But you have a set of criteria that you follow, right?

DR. CARSON:  Yes.  They have to meet the criteria.

CHAIRMAN PELLEGRINO:  I didn't go through all the criteria.  What is happening here is why I have —

PROF. SCHNEIDER:  Oh, I was just going to say that I'm the local prosecutor and I'm sitting here around here with my definitions of death and I'm asking whether when you start extracting the organs after two minutes or five minutes or four minutes, whether you are actually committing homicide or not.  And I have a good case to make that you are as long as you are using your — as you described them — old-fashioned criteria.

CHAIRMAN PELLEGRINO:  Well, the heart, of course, would have stopped by this point.  You have — the electrocardiogram is flat.  You've got no evidence of any other criteria you are talking about.  So I wouldn't be committing homicide.

PROF. SCHNEIDER:  I need to know that they have irretrievably or irreversibly stopped.  I mean this obviously comes up with the Pittsburgh Protocol.

CHAIRMAN PELLEGRINO:  Well, I think again the clinicians here can argue with me but I think the criteria are clear that if you do not get electrocardiographic evidence of activity — electrical activity — for three to five minutes, and five minutes is the upward limit [after the heart and breathing stop], the possibility of returning is — and again we haven't got certitude — the possibility of returning is so low that one may proceed.

And, therefore, I would plead, sir, Prosecutor, I'm not guilty of homicide.

PROF. SCHNEIDER:  It certainly makes a big difference how many minutes you are going to use here.  And the minutes that are actually used in real fact can be smaller than the number of minutes you are suggesting, raising these problems of definition in a legal sense that become quite difficult for the poor prosecutor to resolve as well as the poor doctor to anticipate.

CHAIRMAN PELLEGRINO:  You know, I think you are absolutely right.  But I think it will show in three to five minutes.

The other thing is I guess I've had a little personal work in this but for some years I did electrocardiograms on dying patients to see what did happen — whether they did return.  I'm not saying that my data should solve the problem but others have done it of course.

But many, many years ago, that concerned me.  And three to five minutes is a pretty good period of time of no activity — complete lack of electrical activity.  [Following cessation of cardiac and pulmonary activity.] Anyways, this is only a hypothesis.

The government representative has just pointed out to me that I've talked too long.  And we are going to extend our break.  I promise to be silent from here on in.

(Whereupon, the foregoing matter went off the record at 10:39 a.m. and went back on the record at 11:02 a.m.)

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