PCBE: Transcripts (November 17, 2006)

Meeting Transcript
November 17, 2006

COUNCIL MEMBERS PRESENT

Edmund Pellegrino,M.D.,Chairman
Georgetown University

Floyd E. Bloom,M.D.
Scripps Research Institute

Benjamin S. Carson, Sr., M.D.
Johns Hopkins Medical Institutions

Rebecca S. Dresser, J.D.
Washington University School of Law

Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School

Michael S. Gazzaniga, Ph.D.
University of California, Santa Barbara

Robert P. George, D.Phil., J.D.
Princeton University

Alfonso Gómez-Lobo, Dr.phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Leon R. Kass, M.D.
American Enterprise Institute

Peter A. Lawler, Ph.D.
Berry College

Paul McHugh, M.D.
Johns Hopkins University School of Medicine

Gilbert C. Meilaender, Ph.D.
Valparaiso University

Janet D. Rowley, M.D., D.Sc.
University of Chicago

Carl E. Schneider, J.D.
University of Michigan

INDEX

SESSION 5: ORGAN Donation, Procurement, Allocation, and Transplantation: Policy Options

DR. PELLEGRINO: Good morning. I want to thank you all for being so prompt. It's wonderful. I'm looking around the table. Everybody is here. Splendid, splendid. It's a good start.

This morning's discussion, as I mentioned last night toward the end of our meeting, is to look at certain policy options that have been prepared by staff, Eric Cohen and Sam Crowe. And they're intended to move us a little bit closer to defining the Council's posture on some key questions in organ donation and allocation.

And that project and that report is in the process of being developed. And this morning I think it's very important to those developing that to hear your views particularly on these policy suggestions that they're making.

Once again, I'll repeat what I said yesterday, that we hope you will think of each one of these in the light of the background of the current guidelines, the current practices. But take those as a given because they're taken from the literature and they have been summarized well, I think, by the staff and then to look at each of the policy options.

Now, the way I like to do it — discussions of this kind are difficult with a group — is first to throw it open to you for anyone who wants to take any one of the policy options to comment on. The staff is here to help you, answer questions you might have about what they might have meant for this or that aspect of it.

And then following that, I'm going to make sure that everyone has something to say about these policy options. So I think you're getting familiar with the technique that I used sometimes. And let's go around and see that everyone gets a chance to say what she or he thinks.

So the first step will be to open it to all of you to make any general comments you want or any specific comments about a specific policy or any questions you have of the staff. Carl?

PROF. SCHNEIDER: Being new here, I have no idea what happens next. How do you come from here to actually having a report? Drafting is a long and agonizing business. And getting 18 people to agree to drafting looks like a very impressive achievement to me.

DR. PELLEGRINO: Eric is coordinating the effort of this particular report. So let me ask him to give you his approach to the — we're all in agreement with him, but he can express it more clearly than most of us.

MR. COHEN: I think the idea is to get guidance from this session as we have gotten very helpful guidance from the number of discussions we have had on this subject on the ethical and policy dimensions in general and then do our best to prepare draft chapters of the report. Those draft chapters will then be circulated to all the members, giving everyone a chance to give extensive comments.

We will both revise in light of those comments and circulate each member's comments to all the other members, as we have done with previous reports so that everybody sees every step of the process and so that members both have enough time and a couple of chances to make their comments on the draft.

We have had some reasonable success, I think, in the past in preparing reports that basically everybody can own, even if everyone doesn't necessarily own every single policy recommendation if we go the policy recommendation route. But that's the idea, to take the guidance we get from these sessions to prepare draft chapters and then turn them over to you to give us guidance about how to improve them.

PROF. SCHNEIDER: Thanks. That's very helpful.

DR. PELLEGRINO: Thank you very much, Eric.

Dan?

DR. FOSTER: Eric, one of the things that surprised me about the draft that was given us was what seemed to me a failure to deal with what much of the conversation about the organs was concerned with. We have heard, that is to say, the issue of payments for organs.

I mean, at the last meeting, we said this would be extensively discussed by the Council in its report. And in the last item here, it's already decided that the organ donors should be true donors providing organs not for pay or profit but as gifts of the body to those whose bodies are failing.

And it seems to me that may be something that one would conclude, but if you don't consider that thing in detail as the arguments pro or con, it seems to me that the report is — I mean, there are some interesting items. Okay. You know, we can give some payments to be sure that you get drugs, immunosuppressive drugs, or that you have an insurance policy and so forth.

What we are talking about is a massive shortage of 95,000 people on the things. In my view, there is no possibility that the recommendations that are in here will do anything about that.

And we talked a little bit about this last night, just casually, that renal failure, for example, is going to keep increasing until we can solve the problem of diabetes. Prophylaxis is not going to happen until you control this. So you have got a sort of an unending demand for these things.

So I would really like to understand why it is that this huge issue was, in essence, eliminated with a sentence that says that, you know, we've got to give these things without the arguments that we have been hearing about.

MR. COHEN: Well, thank you very much for that question. Let me see if I can give an answer. Those arguments will be a major piece of the final report, just as they have been a major piece of the earlier working papers, especially working paper number four, which was considered extensively at the last meeting.

We have heard extensively, both in the Council and on the staff, from Dr. Ben Hippen, Dr. Art Matas numerous times. The case for incentives will be given a very full and vigorous presentation in this report and a very fair.minded one.

Now, moving forward, the second part, these potential recommendations — and these really were written for you to discuss. It's not our job to decide what the Council ought to recommend but to put forward in as clear a way as we can ideas that you can discuss and coalesce around.

This part, this short paper, that you have seen will be only one piece of a final chapter that summarizes and lays out all the core arguments. And so there will be three core ethics chapters, as we're envisioning this anyway, on the ethics of living donation, on the ethics of deceased donation, on the ethics of organ allocation.

There will be a chapter that lays out with as much fullness and objectivity as we're capable of, the full range of policy options from presumed consent, from organ markets, from the redefinition of death to a higher brain criteria.

And those arguments for those different policy options will be laid out in full, but our sense from the numerous discussions we've had at Council sessions, from the poll we did of the Council members is that most of the Council wants to try to find policy recommendations that work within the framework of gifting, that one acknowledges the problem. And it's the shortage of organs that we're going to feel.

But ameliorating that shortage is one of the many goods that are at stake in this debate. And what we tried to do is say if we're going to embrace the moral framework of gifting and the moral framework of personal consent, family consent, people's consent not being presumed, if we're not going to redefine death in some dramatic way, are there things that we can do that both promote the care of donors, promote the care of living donors? And four of the recommendations are devoted to that.

Are there things that we can do that both facilitate something like donation, a controlled donation after cardiac death, but also make sure it's done with an ethical framework? Are there things that we can do to make sure that those patients who do receive organs get the drugs that they need to make sure that those organ grafts are successful?

What we have tried to do is lay out a series of recommendations that actually would be serious changes in the current policy. And in many ways, these recommendations are more extensive than those offered by the IOM report, for example, but recommendations that try to build and ground themselves in the ethical framework, which seemed to be where the Council was in general. I don't want to speak for every member, certainly not for you, but that was our sense.

So that's I guess a two-part answer, no, that those arguments are not disappearing. And they will be a major part of this report. And they will be presented in full.

And we have made a great effort to hear from those eloquent defenders of a market system who know full well the human cost of not having enough organs.

But at the same time it seemed that gifting seemed to make moral sense to the Council. And what we want to try to do is offer some policy recommendations that built on that framework but also moved it forward.

DR. FOSTER: Well, that's helpful. It looked like when you start, you know, with these things as the fundamental conclusions, that made me worry a little bit about it.

I presume, just to finish, have you given any thought or has any thought been given to the potential costs of the recommendations that we have in these things? In other words, what I'm worried about is that the recommendations that come here, many of which are thoughtful and I think are good, are going to be extremely costly to do without dealing at all with the fundamental quantitative problem of organ shortage. I mean, so maybe we just wait to see about that a little bit later.

There are a lot of them. We're going to take on the drug costs for life, all of these other things that are in there are going to be very expensive. But I can't see anything that's in here that would be more than a decoration on the problem that we face; that is, the organ shortage.

We may just have to say, "Well, we can't do it." People are just going to die. And as many people as we can save, that's what we'll do. But I just can't see anything in here that would come anywhere close to quantitatively touching 95,000 or however many there really are that are there.

I am encouraged that we're going to be at least detailed about the market problem as a solution or not.

DR. PELLEGRINO: I think, if I'm not incorrect, Eric, we're trying to get a feel of whether these recommendations are supplementary to the guidelines that already exist, A; and B, to get at the specific question of how much it costs will depend upon whether or not you accept or feel a particular proposal here does make sense. Then we can take a look at the economic dimension. Am I right about that?

MR. COHEN: That's right. I mean, once we get a sense that there are particular recommendations here that the Council wants to put its weight behind, it's our job to go back and develop them with much greater precision and much greater detail.

Now, look, this is an ethics Council. We have some economics expertise, both on the staff and on the Council. And we will certainly do our best to paint a picture as well as we can of the economic costs.

This is not going to be an econometric full-scale analysis. And I don't think that's what you were calling for. And I don't think that is what the expectation would be. But what we can do is develop what we presented here in a short form with much greater precision.

And even for those things that we might endorse as a Council, being very clear that there are costs, there are limitations, that these are at best partial steps, partial answers, but also reminding the Council and the leadership of the report that ameliorating the organ shortage is one part of the ends of a policy in organ transplantation but obviously a central one. And hopefully some of these recommendations would facilitate donation, things like paired exchanges and list donations.

Once the Council coalesces around a specific set of recommendations, we will develop them with much greater precision.

DR. PELLEGRINO: I think raising the questions you did is exactly what we're looking for, more input to the staff on whether the Council stands on these kinds of recommendations with, of course, the follow-up depending upon what the implications of each of these recommendations may be. That has yet to be done.

I have Dr. Dresser and then Dr. Bloom and then Dr. Hurlbut and then Dr. Kass in that order. Dr. Dresser?

PROF. DRESSER: I apologize if some of these questions are repeating earlier discussions at meetings I missed. I have a couple of small things and then a larger question.

On page 7, second paragraph under number 5, "Immunosuppressive Drug Coverage," at the very end, you say that if someone receives a transplant in a hospital that's not Medicare-approved, the patient can't get coverage for the drugs. Maybe that's unfair, but also there's probably a reason for that in that they're trying to get people to get their transplants in places that are quality-approved and places that do a lot of them and do a better job.

So I wouldn't want to just throw that incentive out the window. Maybe the way they have an incentive set up is unfair to patients, but I think you have to acknowledge that there might be a good reason for that.

In the next section on geography, I remember it used to be that well-situated patients would get on multiple waiting lists. And there was controversy over that. Is that still permitted? So that might be something. I don't think that was mentioned here. But that seems to me to be something that is probably unfair. People who don't know about that possibility can't take advantage of it.

And then the next section on allocation, there is a discussion of two things. One is a preference to younger people. And that seems to me somewhat controversial. And we probably need to talk about that.

And the other is in terms of trying to give the organs to people who would benefit the most long term and net. I certainly agree with that, but my understanding is that predictabilities in that area are limited.

So the AMA document, Council tradition, ethical, whatever it's called, they endorse this only if there are significant differences; that is, to have one person who clearly would benefit much less than the other, it's okay to draw a line. But if it's something like people where you would say 40 to 60 percent chance of 5-year survival, the chance of being mistaken about the 40 and the 60 percent are high enough that you wouldn't want to draw a stark line between those 2 people.

So I think it would be better to hedge that and say we realize that there's uncertainty. And so this would only apply if you could definitely say somebody has a much better prognosis than another person.

This is one more just small point. On 11 at the top, where you talk about the cardiac death, if the patients don't die quickly enough to become donors, take them back to the intensive care unit to die in a peaceful and respectful way. I guess I never thought of an intensive care unit as a peaceful place to die.

(Laughter.)

PROF. DRESSER: I mean, wouldn't it be possible to just leave them in the room to have a peaceful death? I don't know the logistics of it, but that just sort of struck me.

So those are my comments.

DR. PELLEGRINO: Thank you very much.

I have Dr. Bloom next.

DR. BLOOM: My comment has to do with page 10, category 4. And it epitomizes my concern that we are tacitly accepting the concept that end-stage organ failure is inevitable and that we have to match the supply to the demand.

And we don't say anything in the report about reducing the demand for organ failure replacement. And it seems to me if we look closely at the causes of renal and liver transplants, we will find many cases in which a better self-evaluation of health during their lifetime could have reduced the demand. And if we only talk about supply control, we're never going to meet the problem, as Dan very nicely phrased.

I think that either in the introduction or in the conclusions or someplace, it would be irresponsible of us not to call attention to the fact that we're never going to meet the supply if we let people destroy themselves.

DR. PELLEGRINO: Thank you very much.

DR. HURLBUT: Floyd's comment goes back to the heart of another issue. I was a little surprised looking at these recommendations, not because I didn't think they were very interesting and worthy of discussion, but it seemed like we hadn't quite gotten there yet. I mean, for example, why weren't we offered an option of paying for organs because we didn't absolutely resolve that issue?

It seemed like we haven't addressed certain fundamental questions completely yet, although we have done a preliminary discussion. And out of that, it seems like quite a few more proposals could have been put on the table and then voted on.

More specifically, it seems to me that I have always regretted that we never really talked about Leon's paper, which I think was part of our readings. And it was very rich in fundamental orientation, but we never talked about it.

And I feel like for us to address this for certain types of transplantation, at the moment when transplantation is potentially expanding into new realms, there is something strange about it. It's almost as though we're not doing the thorough analysis that we could do, which would make a real contribution.

I mentioned at the meeting last time the possibility of womb transplants. And several people came up to me afterwards and said they had never heard of it. Well, as you probably noticed in the last two or three weeks, it's all over the news.

And it seems to me that that is just one of several new areas of transplant that will be emerging, especially as we go searching for adult stem cells and so forth.

And we have an opportunity here to address the more fundamental questions associated with commodification and commercialization and make some comment about the spectrum of kinds of transplants.

I mean, I think a womb transplant is a very different social and medical matter than a kidney transplant. Now, if we want to just confine our discussion to a couple of categories of transplant, that's one thing, but at least we need to figure out that is what we're doing.

I personally think we do a greater service if we talked about this with a notion of the body parts apart from the whole the same way we did a little bit about death, which I thought was a really excellent part of our contribution.

Just one other issue here appropriate to what Floyd was saying. In the proposal ahead, it talks about benefitting the young. One thing absent from that that struck me was that there was no mention of the question of whether or not the cause of failure of the organ would come into the equation at all.

So you're going to give equal donation to people who abuse the body? And how many donations in a row are you going to give to somebody when they continue to use alcohol or drugs and so forth?

These are all very serious matters of compassion. Medicine tries not to judge the individual life, realizing the complex realities that go into the tragic circumstances of people's lives.

Just the same, we need to be realistic about the causes of the problems of organ failure.

DR. PELLEGRINO: Thank you, Bill.

Eric?

MR. COHEN: I think it's actually more helpful to us to keep hearing from the members. I can try to comment more generally at the end, but I think we should keep going.

DR. PELLEGRINO: Thank you.

DR. KASS: Thank you very much.

I want to try to touch comments made by a couple of others and then maybe add a comment of my own. I think Dan Foster's point is extremely important. Notwithstanding the additional elaboration that we got from Eric about what that larger report is going to say by way of contributing to a richer bioethics and laying out all of the arguments, one should acknowledge the fact that people are going to read, a lot of people are going to read, this document, will look at the recommendations, and look at the recommendations, if not alone, almost exclusively.

This is a report that has been occasioned, this is an inquiry that has been occasioned, by the organ shortage. That's in the way of how we got into this. We might have taken it up for other reasons, commodification of body, but we took it up under the heading of the organ shortage.

And it seems to me that if, as I think Dan is right, that we are not going to with these recommendations do terribly much about overcoming that shortage, point one; and if the particular measures that we have offered of the sort that are here turn out to be so expensive as to be little likely to be enacted, people are going to say, "Look, they have taken up this subject of shortage. They have suggested a Band-Aid. And the Band-Aid has no adhesive." And in the end, we're left with a shortage. And I think that would be an embarrassment.

Now, I was on my way to making the point that Floyd has made now several times in these discussions. Maybe not just in the recommendations but earlier on in the analysis we have an opportunity to define this problem not only as a problem of organ shortage but, in fact, to think about the question because, look, even if you allow payments in organs and you take that presentation that we had — I've forgotten the man's name who gave us the figures about the people who are on their way to end-stage renal disease. And if we don't get a handle on obesity and diabetes, those numbers are going through this. There aren't going to be enough organs to be sold to deal with that.

So it seems to me it would really be irresponsible to allow the shortage to define this report. And, therefore, I think not only in the recommendations but early on some large discussion based upon that presentation and some of the public health considerations, that would be a major contribution, in fact, in thinking about this because this isn't the only disease for which there would be — this isn't the only area for which there would be massive expenses and great innovations that would be required unless we go to the route of public health prevention education, rather than find some way to bail people out there.

So I think that would be important. I think there should be something in the recommendations here. And I think it should be prepared by a serious discussion, for which we have I think had some background.

I guess that's the larger point. Maybe we're going to come to the particular things on allocation, but it occurred to me — I don't know to what extent this figure is in — whether people in need of transplants have dependent school-aged children or not. In other words, there are multiple lives that are to be affected here and other responsibilities. I would think that that ought to be properly a consideration.

And you might then want to think about veterans and other people who have a special claim for special attention. But I would have thought that who depends upon the old person might have some bearing in the allocation question. That's a minor point.

I think the larger point I think is important. And let me just finish with this. I think given what's in the public discuss about this question, rather than sort of hide from the conclusion, we ought to acknowledge in a way the recommendations that are being offered here. They're sensible, those that we agreed to. They might be desirable. But, rather than simply hide the fact that this is not going to meet the shortage problem, we should own up to it.

DR. PELLEGRINO: Thank you very much, Leon.

I have next Dr. Lawler.

PROF. LAWLER: Let me agree with the argument that began with Dan that there is the sense in which these recommendations start in the middle. Eric explained why that is the case, but still it is a bit jarring that we have rejected the possibility that it is becoming more fashionable, more insistent; that is, the market and organs. And by rejecting the market in organs and embracing the present system of gifting, we, as Leon points out, are embracing the shortage and that the shortage will not be addressed in an effective way.

Let me point out once again, as to the final report and, as Eric pointed out, this is a small part of it. And we're getting responses. And this is exactly what we would like to get. But please be under no illusion that this is the total report. I think Eric has been working with Sam on this with a lot more to go. So what you are saying is very appropriate and right at this time. And do not take the absence as something meaning it is neglected.

I agree with embracing that conclusion, but we are going to have to give a powerful argument for it, giving due attention to the argument in the other direction, which is not trivial. I was most impressed with Ben Hippen when he was here, number one.

Number two, I agree that the recommendations, specific recommendations, are made in justice. They're mostly good ideas. They're expensive ideas. And so, as Dan points out, many of them are unlikely to be adopted. None of them are likely to address the shortage in any significant way.

That doesn't mean I'm against them. I think people who do donate their organs should be properly cared for and compensated for their time and not lose their jobs and all that. But it's not going to increase the number of donations very much as far as I can tell, and it will be very costly.

And, number three, maybe we have not talked about this yet, but the allocation thing seems to me to be very complicated and incompletely and inadequately discussed by us. We would almost have to have a separate meeting for that.

These ideas that Bill had that we should look to the cause of the organ failure and give a preference to people who had contributed nothing to it, it wasn't their fault, that we should look to the situation in the person's life, does the person have dependents and responsibilities, once you start doing these things, though, you're starting to make very complex and tricky and controversial judgments.

And if you're looking on page 10, the net benefit paragraph, I'm not sure what that means exactly, but you could easily read this in this way. A guy, a poor man or woman, who is on dialysis and is doing well would not qualify for a kidney as quickly as someone who was doing badly on dialysis. Now, if I were on dialysis, I might be somewhat irked that I am not going to get a kidney because I have been such a good sport about dialysis, my body is doing okay with it.

For so many reasons, including this one, according to Ben Hippen and the other experts, dialysis can turn on you at any moment. You can be doing well. Then, all of a sudden, you're not. And so the fact that I am doing well on dialysis this week shouldn't be a cause for me being kicked down the kidney list against the guy next to me on dialysis who isn't doing so well. Who knows why.

And, again, that's not a devastating reputation. It's just these allocation questions are very tricky and complex and all of that. I just don't think we have looked into them sufficiently at all. I have a hard time having an opinion one way or another.

In the same way in this preventive medicine question, you know, dumb joke, although I may not look like it, I'm in favor of preventive medicine.

(Laughter.)

PROF. LAWLER: I do think we should emphasize that, nonetheless, there is an empirical question here, also raised by Ben Hippen. He was of the opinion that even successful preventive medicine would not reduce the kidney shortage because a lot of the kidney shortage is going to be a down side of people aging, more old people's kidneys. Elderly people who are otherwise healthy are going to have failing kidneys, people who have had marginally high blood pressure for a large number of years and so forth.

So he told us very insistently that although preventive medicine is a good thing, we should emphasize it. We shouldn't be deluded that it would do much actually to deal with the shortage.

On this issue, I'm not sure this is a factual issue we can come out for preventive medicine, but that can be an integral part of the report. I'm all for that. On the other hand, I don't think we know enough to say definitively that a very successful preventive medicine program would actually reduce the kidney shortage. I think we really would have to do more work there to be sure.

DR. PELLEGRINO: Thank you, Peter.

Just one brief comment. I personally believe the payment question is a critical one and we should face it head on. And it will be — I think the difficulty most of you are having now is that we have jumped into the middle of the play, not sure if it's Romeo and Juliet or whether it's Hamlet or what.

And I think what we were looking for perhaps is, again, just what you're doing, giving us back the things that the Council feels should be emphasized. And I think their absence, let me say once again, does not mean that we have not been considering it, but we really appreciate what you're saying.

Thank you, Peter. Next?

DR.CARSON: Not withstanding the very thoughtful comments Peter just made, I certainly would have to strongly endorse, you know, the wellness concept that Floyd and Leon have talked about and believe that one of the greatest services that we can provide to the government and to this nation is to begin to emphasize more the whole concept of personal responsibility in terms of one's health in a health care system that directs itself more toward sickness than wellness.

As far as the transplantation situation is concerned, now, the bible says that the love of money is the root of all evil. And I can certainly see some scenarios where people would induce death or terminal disability in a family member in order to get money.

Years ago when I used to review policies for insurance companies in cases of accidents, it became very apparent that there was a certain group of physicians and lawyers who could be counted upon to create whatever records needed to be created in order to game the system. And it was obviously done for monetary purposes.

So we certainly have to be very cognizant of that when we enter the realm of payment for organs. And I think it needs to be clear beyond a shadow of a doubt when this discussion finished whether as a Council we are saying payment for organs is unethical or are we saying it's ethical but needs very precise guidelines.

DR. PELLEGRINO: Thank you.

Mike?

DR. GAZZANIGA: Well, just to add my voice of support, I think Bill Hurlbut put his finger right on it. We did have discussions of the market ideas, one unforgettable session you all remember. And while some people may find the concept sort of morally allergic, I kind of think that there is a sense that while we don't like it, we're willing to consider aspects of it. So maybe this will all come out in due course.

I would suggest that, actually, the staff spend some time... or maybe one e-mail to Richard Epstein would suffice. You could get a return model, for those who are actually proposing this, a model of how it would work, what are the number of organs that would be generated. This is what people do. And so we should have an example of that as we come to grips with the kinds of issues that Dr. Carson just raised.

So, in other words, a full exploration of that topic I think is part of our obligation if we're going to continue on this topic.

DR. PELLEGRINO: Thank you.

Dr. Meilaender?

PROF. MEILAENDER: Well, I had a few comments on particular items, but I think I will save those and just make comments on a couple of general issues that have arisen for the moment at least.

First, I was not actually bothered by the nature of the paper and so forth. I mean, I took it to be not by any means the entire project of something else, but I am easier to get along with than a lot of the rest of you.

(Laughter.)

PROF. MEILAENDER: And that probably accounts for that, I'm just sort of an amenable kind of person.

Two other things. I have often as we have had these sessions on this found myself just sort of pondering and not quite certain what the answer was why given its cost organ transplantation has such a privileged position in just the whole scheme of things with respect to health care and the way we spend our health care dollars.

And if people are tossing in bigger questions that they think need to be raised, then I would not think that that is a smaller question than some of the others that have been tossed in.

I mean, I realize there are certain historic reasons. I mean, first we committed to dialysis for weird reasons. And then that generates a commitment to transplantation as a better solution and so forth. But you know why is that?

And particularly if — I mean, the stuff that Peter reminded us of, particularly if it's going to be an increasing number of considerably older people whom we are thinking about transplanting. As you know, I am not interested in judging the lives of older people as worth less than those of younger people, but, nonetheless, just in terms of this privileged position of organ transplantation, you have to ask exactly what the argument is for it. So if we're thinking that there are some fundamental questions to be raised, I think that also should sort of go on the list, really.

And then the third thing that relates to Floyd's comment and Leon's — and other people have chimed in in various ways — I was finding myself in sort of a mixed reaction. I mean, it does seem right to say you should pay attention to the demand side and not just the supply side. And the healthier we are, the less the demand would be.

And it seems right to say that there is a kind of personal responsibility for health to some degree. Illness also strikes in random ways, however. And somehow I guess I would want to make sure if we turn in that direction we distinguish between saying that efforts to make people aware of personal responsibility for their health are good and should be pursued. I mean, it's kind of a nanny state quality to that that I am not crazy about, but I understand the importance of it.

That doesn't necessarily have any implications for who should get a transplant if he or she needs it. There is a kind of harshness or potential harshness that is built into the notion of personal responsibility as well.

So it is one thing to say personal responsibility should lead us to think about ways to encourage people to take care of their health such that they wouldn't find themselves in need of a kidney transplant, for instance. It's another thing to say that the fact that I've not taken very good care of — it's really Peter who has not taken good care of himself — should be a factor to be considered in whether you get a transplant.

As I say, there's just a harshness there if we're talking about a public policy that I at least would draw back from. I don't know where the rest of you would be, but I think at least there's a distinction there that it seems to me important to keep in mind.

DR. PELLEGRINO: Peter? Okay.

PROF. LAWLER: Let me just say in self interest, I completely agree with you on that point.

(Laughter.)

DR. PELLEGRINO: Dr. Schneider?

PROF. SCHNEIDER: I have a few comments. First, I share Gil's discomfort with the "You asked for it. Now you have it" connotation that some of the "You must take care of your own body. And if you don't, you will suffer the consequences. And that shouldn't be society's problem."

I've spent a lot of time with dialysis patients. And they are people, many of them, whose lives are so very difficult from the very beginning that they struggle with a lot of things. And they come without very much equipment for doing well with it.

They're often not very bright. They can't read. They have difficulty with the simplest kinds of numbers. They have, as these things would suggest, very little education. They struggle in their lives in a lot of ways.

I remember interviewing one such man, who told me very proudly that one thing that he could always be grateful for in his life was that none of his children were in jail.

And someone whose social life was at that level of difficulty seems to me somebody for whom it is easy to have a lot of sympathy, even if he's done things that destroyed his body.

That leads me a little bit to this discussion that Peter had said something about about trying to make distinctions about who ought to get kidneys. And when we started off about half a century ago dealing out kidneys, we tried to make exactly those kinds of distinctions.

And that collapsed. And it collapsed for some of the kinds of reasons that we have just been talking about. It also collapsed because it turned out to be too hard to figure out who the worthy people were.

The third thing I wanted to say is a more general and not very helpful comment. I think if you look over the kinds of recommendations that groups like this have been making over the last several decades, when they come to making concrete policy recommendations, you see a record of very discouraging failure.

A lot of things that seemed like obviously good ideas — and I would include things like informed consent and living wills, the Patient Self-Determination Act, I am perfectly happy to go on with the list — that seem so obviously right have turned out not to work remotely in the ways that they were intended to.

What makes me a little nervous about some of the suggestions here is that they are so numerous and so specific and so complicated that it's very hard for 18 people who do this rather glancingly to feel that they really understand the proposals they're making and are reasonable confident that, unlike all the rest of them, that these are actually going to work.

Last comment. On the money thing, obviously I appreciate the importance of not spending lots of money for relatively modest returns. On the other hand, I'm a little uncomfortable with all of the discussion about it because in a lot of the dialysis situations, it's cheaper to have the transplant than it is to have somebody on dialysis for a long time.

DR. PELLEGRINO: Further comments? Dr. Gómez-Lobo?

DR. McHUGH: I found this report very interesting, and certainly the discussion has been very interesting. But I want to enter one aspect of the study of who the donors ought to be.

We have discussed who should be the recipients and the issues of their behavioral and, therefore, their psychiatric conditions that have led them to need organs. I wish I were as sure that we had thought about what has prompted people to be donors.

Now, there's no question about donors who are natural relatives to people who are going to be the recipients, and very little sense maybe that they are in any way disturbed, although they could be pressured in ways that if we really understood and looked into the family status, we might disparage.

At Hopkins, we have the comprehensive transplant program, where you can donate to a list. And we certainly have seen patients, people, who have come to donate to the list in ways that I think that they need help to see that they are not benefitting by this in ways that I as a doctor would encourage.

We had a patient, a person because she becomes a patient when she is a donor, who wanted to give because she had lost a child to kidney disease and thought if she just donated to the list, that it would be a kind of tribute to that child.

Now, I thought that she was still in a state of grief and that, although now with the endoscopic capacities that take out kidneys, it was a lot easier than it used to be, I didn't think that we were really benefitting this person in ways that would pass muster in other ways.

And so I want to be sure that in our report because what we talk about in the donor side is all what kinds of financial benefits we're giving the donors. And I'm not satisfied that we're considering what were the psychological considerations that brought the person to this and whether we as doctors, people who were going to be doing this, are benefitting the person by going along with their proposal.

DR. PELLEGRINO: Dr. Gómez-Lobo?

DR. GÓMEZ-LOBO Thank you.

One really very, very minor point. And it is that in several passages in the report, the word "donor" is written when it should be "recipient." I don't know if you noticed that.

Now, the one thing that I think we should do is perhaps at the beginning of the report insist that we're really basically confirming or backing what already exists. I don't think we should attempt to modify everything, say, that the existing rules have in place, particularly the UNOS rules.

And I thought that in the documents presented last time in the original paper by Sam and Eric, it was very well laid out how the effort to meet demands of fairness and benefit really were invited in the rules.

Now, it seemed to me on that occasion that the only place where certainly improvement on the side of fairness could be made was in terms of geographic allocation.

So I would suggest that we take a very close look at the disparities due to geography. I didn't know you could put yourself on the list in two different places. That would be even worse.

There is an argument there for having something like a unified national list provided, of course, that the organs can be safely transported. And it seemed from what I read that that was the case. So that's sort of a minor point.

Now, I agree with Gil that although we should encourage the lowering of the demand for organs through wellness, et cetera, the moral factor should not go into any decision of assignment of organs. That would be really bad. It would lead to a pre-Hippocratic period where illness is really due to your fault.

My mother, my Italian mother, always thinks that I am guilty if I catch a cold.

(Laughter.)

DR. GÓMEZ-LOBO So that should remain in place, it seems to me, that the factors and the algorithm should not take into account, say, the lives of people. I could just imagine what a nightmare it would be if we even attempted to come close to that. Again, that does not exclude the education, the making the public aware of the need for this.

Now, coming to perhaps what is the major point, from everything I have heard here, from the people who have spoken, I have become very pessimistic about the demand ever being met, even if there is a free market, for the very simple reasons that some of you have mentioned already. The population is growing older. We're not dying of pneumonia and things like that.

So it's only natural statistically that most of us are going to reach old age and many of us are going to need organs. And it seems to me it would be rational to forget that fact. I mean, there are numerous things that are going to happen just because of the success of medicine.

So when we discuss the gap between supply and demand, I would put a very big caveat there that as things are going now and until some alternative is found, I just think the demand is not going to be met.

DR. PELLEGRINO: Bill?

DR. HURLBUT: As a point of clarification, isn't it true that — maybe Dan can answer this — there already are what you might call lifestyle issues that play in the equation? Isn't it true that if a person gets a liver transplant and then goes back into alcohol addiction, that they will not be as likely for the next liver transplant?

I don't see why that shouldn't be part of the equation. I realize the great difficulty of that, of dealing with that, because how many causes do you take into account and what types and so forth. But somehow it doesn't make sense to just arbitrarily assign the organs. It seems like some judgment should go into where the benefit is going to lie from that.

Just one larger comment to that. Putting together quite a few of the comments here, it seems like, notwithstanding the bind we have gotten ourselves into with dialysis, it seems like it's still appropriate to make the kind of comment you just made and put it into policy to point out that if we're feeling the imperative of some action, that there are many regions of human health that are crying out for with equal force or more force government help if that's what we're going to dedicate here.

I mean, if we are going to put a huge amount of money into immunosuppressive drugs, what about vaccination programs? What about carefree young people? Somehow this doesn't make sense, some of what is being implied in this process.

That's what I understood Gil to be saying. Is that right, Gil?

DR. PELLEGRINO: Gil is up next. So go ahead, Gil.

PROF. MEILAENDER: Yes and no. I agree with you that, insofar as you chimed in, I think agreeing with me, that there's kind of a funny privileged position given to this, that's right.

What I wanted also to say, though, was that I think the word "arbitrary" is a very tricky word there. I would regard building into your equation to determine who gets an organ various factors about how you had lived and so forth to be the arbitrary way of doing it, as opposed to a kind of a system that blinded one to those various things.

So, see, the language of arbitrary always suggests, implies some position from which one is in a position to judge, as it were, the whole of a life. And I'm not confident that we're in that position.

So I want to take back the "arbitrary" language. But on the other point, yes, I agree entirely.

DR. PELLEGRINO: Peter?

DR. GÓMEZ-LOBO I'm sorry. Just one point. With regard to the question of transplant for an alcoholic, I would consider that factor a factor of efficiency.

In other words, the reason for not doing it would be because if the person was given already a liver and the person continues to drink, then the chances are that it would be a bad use of the organ. But I would be hesitant to go into some kind of a moral judgment in that case.

DR. PELLEGRINO: Peter?

PROF. LAWLER: Well, me, too. I mean, taking this to its conclusion, this would be kind of a yuppie organ empowerment act or something like that.

(Laughter.)

PROF. LAWLER: The people who have time to get to the gym and have fake jobs like "professor," can exercise half the day long would get organs. People who had all the problems that Carl described and don't have time or other resources to think about their health and get fat because they just eat what is in front of them because they're thinking about their kids in jail and all of this. And so it really is, as Gil says, fairly arbitrary.

On the other hand, that would be my opinion for the first organ. I think if you misuse the organ you have been given, that might count against you in terms of getting a second one. I actually see the point there.

And that becomes less arbitrary, simply because if you prove you can't take care of your organ, so to speak, it probably wouldn't be a very efficient use of resources to give you another.

And with respect to the immunosuppressant drugs, the argument was that it's cheaper than putting these people on dialysis. And that's the only argument that moved me on that particular —

DR. PELLEGRINO: Thank you.

I would like to call on Eric Cohen at this point.

MR. COHEN: First let me just say from our side of the table, this conversation has been helpful in giving us guidance about how to move ahead.

Let me make four quick comments, I guess, in my effort to make some sense of this. First, I guess I feel morally obligated now to put myself on two cheers or three cheers for prevention.

Everybody I think embraces this. If we could do things to make our lives fuller and healthier and prevent the demand for kidneys, obviously we ought to do it. And this report ought to call for it.

That said, we face still a discrete problem of organ failure questions of how to allocate the scarce organs we have, questions about the moral principles that ought to govern the system.

This is a subject being debated on op- ed- pages, a subject being discussed in IOM reports. And I think this Council has a unique opportunity to deepen the ethical analysis, on the one hand; and, on the other hand, to offer some precise policy analysis and perhaps some recommendations. So that's a first point.

Second point, I think Leon is quite right and Dan and others that nothing we have given here is going to be a silver bullet to solve the whole problem and give help to everyone who is suffering on a waiting list waiting for an organ, but the fact that you can't solve an entire problem or ameliorate an entire crisis doesn't mean you shouldn't do those targeted things that you can to make things better and to improve the system.

In a way, we followed this model, I think the Council followed this model in its report on reproduction responsibility. Certain major issues weren't taken up frontally, but there were some targeted policy recommendations that were offered, I think one of which was adopted by Congress and all of which I think have had a useful imprint on the public debate. So the fact that this isn't going to solve every problem, these recommendations, it doesn't mean they ought not to be considered.

Third, some people have mentioned the issue of cost and the potential high cost of these recommendations, leading to them not having much of a chance for congressional or political success. I think we need to be careful here. That may be right. But we have made some effort.

And, again, this is a very preliminary laying out of the ideas. And to the extent that any of these are embraced, we will have to do much more rigorous presentation of them.

The effort here has really been to make these targeted, not to simply say everyone who is a living donor should just have publicly provided health insurance for the rest of their lives but to say those health incremental costs that are related to the act of donation, especially for the poor but perhaps for all donors, the public has some responsibility in the name of care for the donors to provide for them.

The issue of preventing graft failure and whether a public investment in making sure immunosuppressive drugs are available to everybody might, in fact, save money, rather than cost money.

So I think we ought not to be so certain that these recommendations don't have some hope. And some of them are modifications of policies that have already been proposed in Congress, where we could either advance the public debate or put the moral and public weight of the Council behind them and perhaps get them a better public hearing.

Fourth and final point, there is always an issue in the Council's work pace. These are complex subjects. We could discuss them all in perpetuity and never uncover every stone that deserves to be — or turn over every stone and complex issue that deserves to be discussed. And that's really for you to decide how quickly we want to move.

On the issue of markets, we have had the debate between Richard Epstein and Frank Delmonico. We have heard an extensive presentation from Ben Hippen. We had a discussion of Gil's paper, which took up the question of payment for organs and its meaning. And this subject was the most extensively discussed subject in the policy paper that we discussed as one of four sessions that we had at the last meeting on this subject.

Now, it may be the case that we have not had enough discussion on this, but we have had a lot of discussion on it. And the Council needs to have a decision about the pace of its work and whether we want to slow down and discuss issues in greater depth and more fullness or whether we want to take the plunge in drafting and see whether the staff can prepare something that meets the aspirations and ambitions of the Council. On that question, we are your servants. And you have to give us guidance.

I can understanding how reading this paper in isolation you can feel as though we're beginning in the middle, but we're not beginning in the middle. And this paper is the product of eight months of work. Well over 200 pages of working papers that have been prepared on the basis of 4 Council discussions at the last meeting, numerous, numerous discussions, both at the Council and far more sessions from the staff with outside experts.

But, again, you have to give us guidance about the pace and whether we want to move ahead with a kind of aim of getting a report together for Spring 2007 or whether we want to return to this issue, take up the allocation in greater detail, take up the brain death question again, take up the market question again. That's a decision I think you all have to make.

DR. PELLEGRINO: Questions? Comments? Leon?

DR. KASS: Well, just on this last point. And, you know, I am one of 16 around the table, but it does seem to me that there's been an awful lot of work and discussion here. And I at least for one would like to see — I mean, I trust the staff to produce a kind of distillation that would be rich, well-argued, with all the relevant points of view, would be at least presented, and see where we are in relation to such a draft.

I think there is some merit to getting — if it's well-argued, the positions are all in there, even if there isn't agreement amongst us on every point, there is an opportunity I presume for personal statements on it to expand on various points that are not there.

And I think there is a contribution to the debate that we can make based upon what we have done to this point. And I guess I would trust the staff to produce the kind of document that we could then all react to, have an occasion to comment on, and revise.

And then if there are particular pet issues that haven't been properly reflected in this document, the back of the book has been a well-used place.

DR. PELLEGRINO: Leon, as Eric pointed out, there is a much larger piece of work, as you know. And I think what you're saying is the answer in a way to Eric's question of where we go next.

And there is a lot of work that has been done. And I think the purpose here was simply to get feedback on this aspect of it and not the whole thing. And so my own feeling is that the next time we present something to you, it should be pretty much having all of these issues addressed in some way. And many have already been, as Eric has pointed out.

So I don't think there's any disagreement here about that procedure. I think there's simply a tactical question of having presented these in isolation and out of the whole context was not intended to confuse you but, rather, to get the kind of direction you're giving us.

And so we feel, at least I feel, that we're serving the purpose that we had in mind, but we may have created a little confusion by dropping it into the middle of the play, as I say. In medias res always gets you into difficulty.

Dan and then Robby.

DR. FOSTER: One of the things that Leon said is something that I think we really need. I really don't want to be embarrassed by this because the failure to just say what you really think that we thought about this and so forth and so on.

In the material that was sent in that led to the conclusions about gifting and so forth, Eric, was it clear from the individual votes that came in that the Council as it now stands is by a significant majority against the concept of commercialization of this or paying for organs?

If that's the case, I mean, we considered this. And for reasons that are in the report, we can't do it. And we now realize that that cannot quantitatively address this. I mean, is it clear to you? We never had a formal vote around the table.

DR. PELLEGRINO: No, we have not.

DR. FOSTER: Is it clear to you that that option is out? It looks like from this report it is clear to you.

DR. PELLEGRINO: Dan, give me the tally on this.

DR. DAVIS: Well, part of the difficulty is that not all of you responded. In fact, there were only nine responses. And of the nine, there was only one individual who indicated an interest in pursuing the incentives in payment option. So we didn't have a complete tally, but of those of you who did respond, that was the way it came out.

So I think it's important for us to have the discussion that we're having because the results of the survey I think are inconclusive.

DR. FOSTER: Well, I think that's right, too. I think we need to — I don't think nine votes is enough to say what we want to do. And I think you could get out of this without being embarrassed by the ethical discussion if you knowledge the fact that we simply think that, I mean, as a Council, that we don't want to pursue that view.

But then the minor things that might enhance the current system may have some benefit. And that would not be embarrassing to face up to the fact that we have considered this. We realize that what we're saying is not going to solve the problem, that we might make things better as they are.

But to just ignore it, I think that would be a huge embarrassment. There's a lot of — I don't know about the rest of you, but I get e- mails all the time about this issue. I mean, this is a very hot issue as to what we should do.

DR. DAVIS: I don't think there was any intent to ignore it. I think as we thought about how we developed this report and then vetted, we figured there would at least be two more venues through which we would take up the issue of payments and incentives. And this is one.

And then certainly once you see it in concrete in text, each of you will have the opportunity to react to it. And if those reactions go one way, then fine. We may need to bring it back for another meeting.

DR. FOSTER: Well, I want to make clear that I don't want to have additional long discussions about that. I think we've discussed it enough. And maybe the correct way is just to get the whole report out, like we have always done. And then we can respond to it.

But I do think there ought to be some sense — I don't know whether today is the time to do that, to take a vote or not, but that —

DR. DAVIS: I think certainly with the allocation issues and some of the issues around complexity that Peter has raised, we acknowledge that. I mean, certainly all of the proposals were offered with a degree of tentativeness.

The allocation recommendations were offered with a high degree of tentativeness because we have not had the kind of in-depth discussion that we have had about other issues in organ transplantation. So those are in there today just to see which way is the wind in the Council blowing on those particular issues. And then we know we have to go back and further develop those. Those are exceedingly complex.

Just by way of a clarification, the kidney allocation formula is about to be revised. UNOS is going to open for public comment a revision that will incorporate net benefit analysis within the kidney allocation formula. So this is coming down the pike.

And so one of the reasons why we want to put that in there is because it is going to be very much in the air within that particular community within organ allocation.

DR. PELLEGRINO: Robby?

PROF.GEORGE: Yes. Thank you, Dr. Pellegrino.

I want to reinforce some points that were made by Dan and Leon and Mike Gazzaniga. I think it's important to remind ourselves again that we're not here legislating. And even our policy recommendations really aren't specific legislative proposals. We're talking about some very difficult issues here, particularly I think the issue of commercialization.

And I would reinforce Leon's point that we got into this in large measure because of our cognizance of the shortage and the real problem that that creates for people. We have to say something about it. And we have to face up to the implications of whatever it is we're going to recommend.

I think it is worth remembering that some of the most important contributions the Council has made in its reports over the life of the Council have been simply in putting before the President and the Congress and the public the best arguments that are being made by well-informed, bright people on competing sides of an issue, not necessarily trying to resolve it knowing that we on the Council are divided ourselves on the issue but just putting into a very intelligible form that the public can consume the very best things, points that are to be made on competing sides of the issue. And this is what I would suggest for the issue of commercialization. It cannot be ignored.

So our contribution I think probably is not to come up with necessarily a recommendation, although it may be possible for us one way or another, against it or for it, but just to make sure that the report really does include the best possible arguments for the competing points of view.

This is a point on which reasonable people of good will disagree. And there are important arguments on both sides of the question or all sides of the question, maybe more than two sides of this particular question.

And I would reinforce the point that Mike Gazzaniga made. I do think in talking about the commercialization option, it is important not to talk about it simply in the abstract but to talk about it in light of something approaching a more concrete proposal about how it would work.

Part of my own problem in trying to think about it after listening to the debate between Richard Epstein and Dr. Delmonico and so forth was it's hard for me to get my mind around it just as an abstract debate. I would like to see a kind of more concrete proposal of how commercialization would work if, in fact, we went down that road.

Now, I don't know if Mike's suggestion of just an e-mail to Richard Epstein would get us what we needed there, but there's probably enough out there in the literature and perhaps talking with Professor Epstein or others about how they would more concretely envisage such a plan working might be helpful.

But my fundamental point is really just that I think we would make a contribution in this area by making sure that the report makes available to that segment of the public that is really interested in this the best arguments that are being made on the competing sides. That in itself would be I think a very great contribution if no recommendation were made, even if no recommendation were made.

DR. PELLEGRINO: Thank you.

PROF. DRESSER: If we haven't discussed as the Council this issue of giving preference to younger or older and how that should be done, I think that's an issue we ought to discuss. I guess personally I could say if there is a 20-year-old person and an 80-year-old person and they have an equal opportunity to benefit in terms of how long the organ is going to last, I would say, yes, give it to the 20- year-old, but you mentioned here to give a point for age, the number of years. I'm not sure that incremental approach is a good one.

I think some of this is subsumed by ability to benefit. So that if you have a good medical assessment that says this patient, the organ is likely to last X number of years or so forth, you can finesse some of the age issues with — it's just very sticky to get into age-based rationing based on prior bioethics discussions. So if we're going to do that, we need to do it in a very rich and well-argued way.

DR. PELLEGRINO: Thank you.

Leon?

DR. KASS: Mr. Chairman, I don't know if this is helpful or not, but I'm sort of mindful of where we are in the session. And it seemed to me you had begun and the staff is also interested — the conversation is about general things and how this fits with the larger report.

And I wonder whether you think you have enough input from this group on the particular nine, is it, nine recommendations that we've got. I doubt that there's enough time to discuss each of them in detail, but would it be helpful, some way to get some expression of support for these things as they now stand or — I mean, how could we be helpful with respect to the document that is here and what is before you.

DR. PELLEGRINO: Well, I personally think it has been helpful in precisely the way I had hoped. I will ask Eric to add his comment as well.

By getting your comments to this set of proposals, which I think have been interpreted as perhaps being more concrete than we have expected in casting them, I think you have been giving us the kind of direction the staff has been looking for.

We have had a lot of discussion, as has been pointed out, but when we get down to the specifics, of course, is where always some clarification had to be needed.

I agree thoroughly with you, Robby. As a matter of fact, when I undertook this enterprise, which sometimes gets painful, as it is now, I did it with the very idea in mind to have said it's the way we should go because we have been going that way. On the other hand, we need to hear all of you express your opinions. You have been doing that.

So, Leon, I think we have been getting what we want. Everything you have all been saying around the table we have talked about also. But we need to know where you are. And you have been giving us direction. And that has been very, very helpful. So at the present moment, I would suggest the following.

Having listened to this discussion, I think you know we will be going back and taking a look at the document and getting ready for a more advanced document, number one.

Number two, there hasn't been time perhaps for all of you to express your views. And we don't have the time this morning. I would like to ask you if you would be willing to offer a synopsis, either personally or write something, about what you think are the major issues. I would not make these recommendations the total focus of your comments, as they have not been.

So, without going on and on here, Leon, I think you have been very helpful. And I think that it is our task now, staff, to come back with the next steps, which is to take under advisement what you have given us.

I could have made maybe speeches to almost each and every one of you on this point, on your points. So I have no great difficulties personally in absorbing what you have been saying. I feel it is very important.

Does that answer your question?

DR. KASS: Yes, it does. Well, yes, it does. And it's welcome. Then unless others would like to do something, Rebecca in a way raised the question on the allocation issue, about which I don't know that we have had a discussion. And there are some very concrete things here.

I'm not sure what my colleagues think about some of these matters.

DR. PELLEGRINO: I don't think we do either. And we will be preparing something on allocation. Dan's already working on that aspect of it. It was not ready for this presentation, but allocation will be within that final.

Allocation, cost, prevention, all of these have come up. And I really think the next point is to get the next step to you in writing so you can look at it, something that you can look at.

Robby, I think your body language suggested —

PROF.GEORGE: Since we do have just a few minutes, Leon, I have a sense that there were some specific points that you were going to make perhaps about 6 and 7 in the document. I'd love to hear that, at least get them on —

DR. PELLEGRINO: By all means, by all means.

DR. KASS: No. I mean, this is not well-thought-out, but, I mean, when Rebecca says — anything that sort of smacks of age-based rationing begins to make her uncomfortable.

PROF.GEORGE: Probably fills her e-mail files as well with people writing in because I know how worked up people get about anything that approaches age-based rationing.

DR. KASS: Granting that working out the system would be difficult and the tacit implication that the life of an old person because old is somehow not of equal value to the life of a young person, I grant those difficulties.

But I must say in reading this through, the kind of spirit that would give preference to youth and in my own case not just youth but also those young people on whom lots of even younger people depend, I mean, you know, I've had my kidneys for 67 years. That's a pretty good run. If I need a new one at this stage, I'm not sure I have a kind of claim on the system that Bill Hurlbut has with two small children, other things being equal.

And how you operationalize this and whether you can operationalize this without doing more risk, I don't know. But if we are coming to the point that the major candidates for organ replacement for wonderful stem cell-based regenerative medicine is going to make all of this necessary, if the major population is going to be people who just managed to live long enough to need their organs replaced and this is a privileged expense in the health care system, you can just see where the direction is going. And I'm not sure. I'm not quite comfortable with that.

So I was not bothered by the way this was at least discussed, though I grant that there are some difficulties in making the thing operational and doing so without invidious distinctions that would somehow say the life of an old person is not as worthy.

DR. PELLEGRINO: Thanks, Leon.

PROF. LAWLER: I agree that there is finally something creepy about taking a 20-year-old's kidney and giving it to a 70-year-old guy. And so I feel there's something there. I think Rebecca is partly right. I don't know how to operationalize this either.

We don't want to forget the real practical problem that the general tenor of the existing system, soon to be reformed, is perverse. You end up on a waiting list. And so on dialysis, with every passing year, you become less likely to benefit long term for the kidney. And you get the kidney when you could have benefitted from the kidney a lot more had you gotten it a couple of years earlier.

So the present system by just rewarding longevity on the list might well be a very inefficient use of the scarce resources of kidneys we have. So it cries out for reforms, but all the reform efforts turn out to be very problematic because of all the factors we have been talking about.

So I have to admit I just don't know enough. I completely endorse doing something about the geographical disparity. The other issues I'm just not clear enough on right now. I think something should be done, but I don't know what should be done with that.

DR. PELLEGRINO: Gil?

PROF. MEILAENDER: Two comments, none of which can do justice to the crux of these issues. Just to put it on the record, I have a hunch from our previous discussions that I am perhaps the only person here who feels this view.

I am the one person I think who is not persuaded on the geography question, but the one thing I would say is I think the argument if it's to be made should be made without the language accidents of geography. I do not know what the term "accident" means there. I do not know what perspective it presumes. I do not think it's necessary an accident to be a Hoosier.

(Laughter.)

PROF. MEILAENDER: And that language has certain philosophical uses. It presupposes certain commitments. And I would get rid of that language at the very least. I actually have some problem with the argument generally but at least that language.

And the other one, on the age thing, I would at least try to go as far as I could with the alternative suggestion that Rebecca made, namely that the relevance of age may be simply that there is less medical benefit to be gained and it's less likely to be helpful for an older person than a younger person.

If it were really the case in some particular instance that it were much more likely to be beneficial to the older person than the younger person, it's not clear in my own mind that just being younger and not having had your kidney for 67 years, only having had it for 27, you know, it would be decisive, in fact.

So I don't know. Maybe that argument won't work or solve the problem, but I would at least want to see whether simply trying to work it out on narrower medical grounds might not get some of the concern met without seeming to make it turn on simply how long you live, though I don't deny a certain sensibleness to Leon's comment as well. I just think there are a lot of problems it raises that perhaps one can avoid.

DR. PELLEGRINO: Yes?

DR. ROWLEY: I have two comments, one of which is that I'm very surprised that people haven't raised a question in the first category, one about unpaid leave for absence for organ donors. You do say that six or seven states actually do recommend payment for leave. And this has come up in California with egg donations and that certain women just cannot be egg donors if they can't get paid for the time they've missed. So I'm surprised that people haven't at least raised the question whether that's a good idea.

And the second thing, I think it would be really informative, Dan, for you since there are 15 of us, including Dr. Pellegrino, here if, in fact, we upped the numbers from 9 voting to include those members of the Council who are present on the question of paid donors.

And I understand what a departure this is in all areas of donation. And, yet, I also know that it's one of the contentious issues in California on egg donation, not paying. And so it seemed rather surprising to me that the only person who does not benefit from $100,000 that it costs for a kidney transplant is the donor of the organ.

So I would be curious to know with more of us here what the general feeling is because I want to point out that Ben Hippen wasn't suggesting that it be one or the other but that we have a dual system: donation and marketplace for kidney procurement.

DR. PELLEGRINO: Thank you. Thank you.

Well, let me close this session by thanking you again for making the comments we were hoping to get; giving us the directions that we ought to be moving in in looking at the next stage; and urging us, and I think quite appropriately, to bring us down to a more finished state.

And I think we served the purpose. I want to assure everyone that the points they have made have passed to our minds. And you have helped us to give them some weight.

(Whereupon, the foregoing matter went off the record at 10:04 a.m. and went back on the record at 10:21 a.m.)

SESSION 6: THE ETHICS OF HEALTH CARE

DR. PELLEGRINO: Our next speaker is Norman Daniels, whom all of you should know or have heard about on this subject. He is the Mary Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health. Few people are as well-published or well-read on this subject as Norman is.

We have asked him to address the question which has come out of the survey we made about topics the Council members might be interested in. Dr. Daniels is going to make a presentation. And then Dr. Dresser has agreed to open the discussion. Thank you very, very much.

Norm, if you don't mind, the question is yours.

DR. DANIELS: Thank you. It is a pleasure to be here. And I thank you for asking me to talk about a topic that I have been thinking about for about 30 years. It shows how slow progress is sometimes.

In any case, what I wanted to do today was to briefly address three questions. I gave you in your paper background briefing book a paper that I had written about five or six, seven years ago now.

And I am in the process of just making the final revisions on a book called Just Health, which is a sequel to Just Healthcare. And that book contained the core ideas about opportunity in health.

I will briefly touch on those, but I want to go into some issues that I think go beyond that and also have a bearing on the very general question that I was asked to address, what does a good society have to do about providing health care for its population?

Well, I'm not really sure I know what a good society is. I'm assuming that a good society is at least a just one. It may be more than that. And so I want to actually answer the question, what does a just society owe its population in the way of the protection of health and promotion of health?

To get at that very general question, I want to answer three questions, why is health especially important? When are health inequalities unjust or unfair? And how can we meet health care needs fairly when we can't meet them all?

I think these are very central issues within any conception of distributive justice for health. And I want to say at the very end of my comments just very briefly how I would unpack the concept of a right to health or health care using the answers to these questions.

So the first answer really draws on work that I did some 20.odd years ago, 25 years ago. And I should add that in the other reading in your briefing book is the chapter from the President's Commission report in 1980 or '83. It was drafted over that period of time.

And I worked closely with Dan Brock and Dan Wikler and later Allen Buchanan, who were the staff philosophers connected to Alex Capron's effort at that time.

They put together a supplementary volume to the Securing Access to Health Care report that contains philosophical essays on justice in health. And there was the report of which you had a part.

I was asked to comment on it. All I can say is, well, we haven't done much that they recommended in 30 years. And it seems to me that that is the point to be addressed in some way or other in the outcome of what you do about this, not that there weren't efforts to try to do some things about what they recommended.

Okay. So the fundamental intuition behind the answer to the first question is to draw a connection between the importance of health and the reason we give it a lot of prominence. Often we can point to other countries where there is universal coverage and access to health care.

But I think if you actually look at the American system, despite its imperfections, very serious ones, and huge gaps in access to care, 45 million uninsured people, we still in principle carry out some of what might be thought as the principle underlying other countries' work, namely we think poverty should not stand in the way of access to health care. And so we have a Medicaid system, imperfect as it is. And we have Medicare as a universal coverage system for the elderly.

So if you take those two pieces together, you might draw out of them an implicit set of principles that would say, in effect, "We are recognizing the fundamental importance of giving universal access to health care." But, of course, we have left out the near poor. And that is a very significant gap of what we do.

Here what I am trying to get at are some of the ethical underpinnings for thinking that health care is special and ought to be treated in a special way within developed systems. So the basic intuition is carried in this argument.

Disease and disability are departures from normal functioning. I'm taking normal functioning to be equivalent to the notion of health, a lot of controversy about that, but I'm going to leave that aside.

The other premise of this argument is that departures from normal functioning or, let's say, significant ones, impair opportunity. And what I have in mind — I'll show you in the next overhead — is the range of plans of life that people could reasonably choose to pick among given their talents and skills, were they otherwise healthy. Okay?

So that's the conception of a normal opportunity range. It is a socially relative notion in that different societies would have different ranges of opportunities open to people. And it's relativized to people's capabilities in terms of talents and skills for entering different plans of life.

The idea is that across all that dispersion of talents and skills in a population, health interferes in a very systematic way or bad health interferes in a systematic way. And that is the intuition underlying that premise.

So meeting health needs protects or promotes normal function. And so the fundamental conclusion I drew from thinking about this was that if we wanted to look for a very general principle of justice that connected the importance of health to our overall concerns of justice, it might be a principle that protected fair equality of opportunity. In our society, that is a very widely supported principle.

So I think there is a grip for this idea within American culture. And the basic idea, then, is that if there is going to be something like a right to health care, it's a special case of a right to protection of opportunity in society.

And that is the core idea that I developed in an earlier book. I think what is different about my thinking now is in the third bullet here, where I talk about meeting health needs.

When I first wrote Just Healthcare and published it over 20 years ago and the President's Commission in 1980 drew on the argument about opportunity in the chapter you read, I was largely thinking of health care as the primary determinant of health in a society. And lack of access to health care would be the source of health inequalities in a society. And the inadequacies in delivering the right kinds of health care to the population would be a way to characterize the failure to meet the needs, health needs, of a population.

I now have a very different and boarder picture of the social factors that affect health in a population. Even in the earlier work, I was always thinking of public health measures as included among health care measures. So clean water and so on were all in my mind health care.

As we will see as we go on, there is an even broader range of factors which affect population health and its distribution. And these are often referred to as the social determinants of health. So I'll say something about them shortly.

This is a little picture of that core idea about the opportunity range. And so what I am suggesting is that a well-functioning effort in all dimensions to protect health for individuals will keep key individuals retaining what is in the blue circle, what I think of as an individual fair share of the range of plans of life that they have.

The red circle is the range of plans of life that's reasonable for everyone in a particular society to pursue, cutting across all the differences in talents and skills. So it is the union in set theoretic terms of all the individual fair shares that might be present.

The green circle, just to characterize the difference, is an individual might decide to pursue certain of his or her capabilities or talents and skills, develop them extensively, and let others lie fallow. And then one develops a particular subset of the individual fair share as the effect of opportunity range you're pursuing.

What we do in health care is we often give people a choice to use medical services, let's say, to restore functioning. And part of what might drive their individual decision-making is their concerns about what is important to them given the effective share that they have.

What society has to adopt from a social perspective is keeping people functioning within the blue circle, normal functioning, because we don't want to in a sense lock people into previous choices about what they thought was important to them so that we would want medical services to restore normal functioning, regardless of how much of that an individual is intent on using.

So that basically draws a conceptual connection between health and opportunity and its importance. What I have on this overhead is some possible grounds or sources for giving prominence to a principle that protected equality of opportunity because in a sense, my argument before simply appealed to the fact that a lot of people think opportunity is important.

But here are some systematic approaches within the theory of justice. Where there is a strong effort to try to provide foundations for a principle of fair equality of opportunity in Rawls' case, that could be connected to intuition I had about the relationship between health and opportunity.

Rawls's contractarian theory generates three principles that he calls justice as fairness, the equal basic liberties of fair equality of opportunity principle; and a principle compressing the inequalities in income and wealth, making the worst-off ones as well-off as they could otherwise be, he calls the difference principle.

I am going to come back to that shortly. And that's the reason I have for mentioning it now. I am not trying to defend any one of these theories. And the argument I am giving doesn't depend on defending any one of them.

What I did want to do is point out that several other lines of work, both of which are critical of Rawls in the last 30 years, also focus on opportunity. Maybe we're using a slightly different terminology in Sen's case.

And I would draw extra support for the importance of connecting health to opportunity from the convergence of these three different views in this way on an opportunity space as being central to health care.

Sen's view is that what justice is concerned about; in particular, what we're concerned about when we're concerned about equality, is giving people access to an appropriate set of capabilities to do or be whatever they want to be. Well, capability to do or be what you want is an exercisable life plan within the opportunity range.

So I see this as a terminological difference but conceptually very much the same sort of space that I had in mind. We were sort of focusing on this idea independently but roughly at very much the same time: 1979-80.

I kept the opportunity language because I was trying to figure out how to extend Rawls. And Sen was anxious to distance himself from Rawls in certain ways. And so he had this capability space. But I think they're talking about the same thing.

Somewhat later in the '80s, another theory came along. This one, in contrast to Rawls and Sen, uses a welfarist view of well-being. So we're thinking in terms of some sort of welfarist view, desire satisfaction perhaps, maybe an objective component thrown in by Jerry Cohen, advantage. But the idea there is that opportunity for welfare is the core notion.

So the idea is that we are owed compensation by others for disadvantage or losses in welfare we may have relative to others if we have been denied the opportunity to develop a life with as comparable a welfare range as other people. And so this is where the opportunity comes in.

So my point is that disease and disability, serious departures from normal functioning, would on all three of these views show up as significant impairments of either capabilities or opportunity for welfare or denials of fair equality of opportunity.

So I'm taking, trying to build on the idea there might be convergence across a range of theories of justice on the importance of opportunity space as something that justice has an importance focus to protect. And I would say that this overall idea is very compatible with what a lot of people in the country think who talk about opportunity.

So that's the end of my comments on the first point about the special importance of health. Health is of special importance because it has an impact on opportunity.

And we have social obligations to protect opportunity that can be defended from several different lines of theory. Obviously not all theories of justice would give prominence to a notion of opportunity. It wouldn't play a singular and distinct role within a utilitarian framework. It might not be important within a libertarian framework. But it is important for a broad range of other views that happened to coincide on that point with a lot of public views about opportunity.

Well, let me move on and say something about health inequalities. This was the second question that I thought was a core question to address in thinking about justice and health.

Knowing that if you meet health needs, because they are of special importance, knowing that that is an important thing to do doesn't tell you exactly which health inequalities are unjust or unfair because it could be that in a just society, which allows for a range of inequalities of other sorts, there are going to be health inequalities that are permissible. So which inequalities in health do we want to single out as unfair or unjust among all the inequalities we could observe?

Suppose we had a religious group that because it engaged in very safe sexual or dietary or exercise or whatever practices had much higher levels of health than other groups. Would we say that the inequality that was generated by that behavior, assuming the other groups had reasonable access to good information about health practices and so on, would we say the inequality is unjust or unfair? I don't think most of us would assume that or conclude that.

And so not all inequalities we see are likely to be ones that we denounce as unfair or unjust. But there are some good examples that we would probably pick out that way, including perhaps many race disparities that we notice in the United States in health, even though the mechanisms underlying them are not completely clear. And without a clear view of the mechanisms, we might not be able to pass a judgment about the injustice or unfairness of a particular inequality. So we have a general task. How do we figure out when inequalities are unjust or unfair?

Now, what I wanted to say is that this point does not loom as a core issue if one thinks health care is a primary determinant of health in a population because then if you think that's true, so that the inequalities we see in health are the result of inequalities in access to health care, then one has a very narrow picture and a very clear answer about when you think health inequality is unjust. It is unjust whenever inequalities in access to health care generated the inequality that we're talking about.

But — and this is going to be a very important point — many health inequalities, maybe most of the ones we see, are not attributable simply to inequalities in access to health care. And if that's true, we have a much different picture to address in our thinking about justice on this question.

So what I have picked out here derives from work that I did with two social epidemiologists about eight years ago, eight or nine years ago: Bruce Kennedy and Ichiro Kawachi. We were Robert Wood Johnson investigators together. And I was caught up in a lot of their work on the social determinants of health.

And we together decided to think through what some of the implications of that would be for justice and health. And that's where some of what I'm about to say next comes from.

What we know, these are sort of four general points that I think nobody would disagree with in the social science literature about social epidemiology. There are observed socioeconomic gradients of health that vary with policy and are not simply dependent on the laws of development.

One way to illustrate that is — I had a graph, but your instruction said no more than 15 slides. So I followed the rules. Now you'll have to listen to me say what I could have shown you.

If you look at a slide that graphs on the vertical access life expectancy, say, by country and across the horizontal access, it graphs gross domestic product per capita, so we're looking at what's the impact of aggregate wealth in a population on life expectancy in that population, you get a curve rising sharply on the left and tapering off as it goes to richer and richer countries.

What this graph generally suggests to some people is that there is a definite impact of wealth on health, especially, say, in the low/middle-income range, below 5 or 6 thousand dollars Gross Domestic Product per capita. Above that, the effect of wealth is very hard to detect.

But one of the striking features about this graph if you look at it carefully is that variation, even among very poor countries, overwhelms this effect of wealth on health in the aggregate.

So that you find very poor countries, like Cuba or like the Indian State of Kerala or like a middle-income country like Costa Rica, that have health outcomes that are on a par with advanced industrial countries or just about there. At the same time, you have other poor, equally poor, countries whose life expectancy might be 30 years less than you find in the developed countries.

So wealth is not the decisive factor. But coupled with policy, how to invest your wealth, for example, in Kerala, this is a state of India that has a matrilineal history of transmission of property. It provided a fertile ground for not disempowering women, as they were in many other South Asian contexts. And when a left wing government in Kerala started to emphasize the importance of investment in education, even for women, women were not excluded from this and there was a long cultural background to support it.

So there are historical accidents that provide a climate in which a social policy can take root. And what the effect in Kerala is is something we have observed many places.

Literate women do a much better job of protecting the health of their young children and getting them health care that they need and getting them access to better opportunities, work, and other things later in life.

So this fundamental investment in human capital makes a difference. And it has a huge impact on the distribution of health in a population. So that's part of a way of illustrating the point about socioeconomic gradients not being matters of laws of development but varying with policy.

These gradients, I might add, operate across the socioeconomic spectrum. So it's not simply a gap between poverty and non-poverty. It has a big impact in middle-income ranges.

The steepness of the gradient is affected by the degrees of inequality in a society. There is a raging controversy in the empirical literature about a thesis called "the relative income thesis." I won't go into it unless you ask questions about it. But it doesn't affect the main point that I'm trying to make.

The causal pathways are under investigation. What we know is a lot of correlational literature about the importance of these determinants. They're called determinants as if they're causal. But what they really are are associations.

There is a book by Michael Marmot, which he is trying to attribute, a book called The Status Syndrome. And he looks a lot at status differences of people in different work settings and otherwise. And I'll show you a slide coming out of his work in a second.

In that, his basic picture is that the mechanism through which this works, through which a lot of the socioeconomic gradient works, is very ancient. It goes back to the effect on immune systems of hierarchies, social hierarchies, which we can find among animals and others and so on.

So this is a particular causal hypothesis. I'm not giving any credibility to it just by mentioning it. I just want to show you this is what these hypotheses, these associational hypotheses, suggest as avenues to explore.

This is a slide from Marmot's work, a very famous picture. This is the Whitehall study. And the reason I mention this is it's very important for people to understand that this is done in Britain, universal health care.

All the civil servants talked about here are none of them poor. They were all making a decent minimum income or better. They all have basic educations. They're all literate or more. They have gone through British primary school and so on.

And what you see in the vertical columns above the bar, the horizontal bar, you see administrative and professional and executive levels with a much lower risk mortality rate than the worse-off groups who fall below the bar.

And if you draw a line of these bars, you have got the socioeconomic gradient of health in a part of a health system that has universal coverage and in which significant health inequalities remain, despite the presence of universal access, basic education, and various — the lack of real poverty. Okay?

I find this striking. This is a very robust finding. It is replicated all around the world with many measures of health outputs, disease.specific, for example, various measures of cardiovascular. Some diseases are not so sensitive to this, certain cancers, but other things, like diabetes, heart disease, and so on, show up as very significant factors.

So this is a very fundamental thing for people in bioethics to keep in mind. Health care is very important, but it's only one of the determinants of population health and its distribution in a population.

So what we owe each other is a proper distribution of these other determinants if we think health is that important. And if, as I do, we think health is important because it protects opportunity for people. Then other factors about social justice besides simply access to health care are going to become very prominent in thinking about the distribution of health in a population. So this I take to be a step beyond the way I was thinking about this problem 30 years ago.

Yes?

PROF.GEORGE: Could I just ask you to walk us through it a little bit? I am having trouble distinguishing the colors except for the darkest one there. Can you just tell us who is who here very quickly?

DR. DANIELS: Sure. Your tallest bar is your administrative, the highest levels within the system. This is your administrative level. This your professional. I think I misstated. So this will be your clerical. So these have twice the mortality rate.

These are the other of the other means, like manual workers within the civil service, janitors. These will be your white collar clerical workers. These will be your professionals within those. These are your high-level political managers and so on of the British Civil Service.