Staff Discussion Paper - Policy Proposals for Council Consideration and Possible Action DR. PELLEGRINO: Good afternoon. Good afternoon. Thank you. Thank you. I think we're ready to begin our afternoon session. Thank you very much for being so prompt. This afternoon, we move to the question of caring for the donors and the recipients, the ethical issues and some of the other problems and policy proposals, very specific policy proposals. And we invite your comments as always. The discussion this afternoon will be initiated by Rebecca Dresser, who was kind enough to accept our invitation and Dr. Carson, if he's here. I believe he may have left. He wasn't able to stay. So Rebecca, it's all yours. PROF. DRESSER: Well, I will try to shoulder all the burden here, but I hope you all help out. These are fairly specific proposals, so my comments are generally specific. I want to flag some concerns, not necessarily with the intention of opposing the proposals, but just point to some worries. I do have one broader allocation of resources question: Is it right to use tax dollars for benefits to donors, rather than using the funds for clinics in poor neighborhoods or other possible uses? But in the absence of a systematic approach to healthcare priority setting in this country, we make allocation decisions that may not be the most ethically defensible use of limited resources and programs that seem appealing within the limited context of organ transplantation aren't necessarily the best or the fairest way to address the broader health or other needs of the community. And the paper certainly acknowledges this concern. But I hope that even if the Council approves these proposals as humane and sensible adjustments to the existing organ transplant situation, I hope the report will acknowledge this bigger picture and acknowledge that funds might be used for more compelling human needs. With that said, and the paper notes, more successful kidney transplants could reduce healthcare costs related to dialysis and so in that sense might free up some more money for other programs. I'm not sure how that will actually play out. But here's some comments on the specific proposals. Unpaid leave. I don't have any strong feelings against that. I think it's fine. I wonder in practice how necessary it is. I wonder if most employers already would consider organ transplantation a reasonable basis for invoking the Family Leave Act. I don't know. I'm sure it would be okay to be explicit, as far as I'm concerned. On the tax credit proposal, one point about that, it said only if the organ is actually removed would they get this credit and for the expenses. In research and surrogate motherhood and egg donation, even though we might say it's hypocritical, the view is that the expenses and compensation should be covered according to the time and the procedures that are done, that is, more of a wage model, not "you ought to get paid at the end if you give up your eggs or your organs or your blood or whatever it is for research." That issue should be — the appreciation shown to you should cover the investment of time and trouble and so forth that you've put into it. And if you wait and make the compensation reimbursement contingent on completion, then you're penalizing those who have to drop out for medical reasons or other legitimate reasons. So I would wonder if it should be structured that way. On life and disability insurance for donors who lack it, this seems morally appropriate to do something along these lines. I don't think we should be too specific about how to do it, given the limits of our expertise that some of us have talked about this morning. I question whether it would be feasible or ethical to tie eligibility to being compliant with follow-up care. I think it could be difficult and perhaps — I think it would be problematic sometimes to say well, you're not compliant enough and therefore you're not covered any more in your family. You and your family can't benefit from this and we'll abandon you. Those situations can get sticky. Supplementary health insurance, again seems more like defensible to provide to donors who wouldn't otherwise be covered. People shouldn't have to go into bankruptcy because they can't pay the health care expenses that they've incurred because of donating. Maybe our economists can comment on this. If the target population is low income, I'm not sure that tax credits always help a lot. I've just heard people talk about that, so that could be an issue. Prohibiting insurance companies from treating donation or resulting complications as pre-existing conditions. That seems fair, but then why is it all right for them to treat things like naturally occurring health conditions, congenital heart defects or something or an accident-related injury as a pre-existing condition? I think there are a lot of fairness issues across the board with "pre-existing conditions," so I just have to say that. Also, I would point out that we don't have these kinds of programs for research volunteers and their families to help when people suffer harm from study participation. This has been discussed a lot through the years, partly because of concerns about causation, that is how you tell what's the cause of the problem. But there's never been enough consensus and enough energy to create a program like that, except I believe in the VA, they have something like that. So again, different kind of treatment for people who are allowing themselves to be put at risk for an activity to help others. Last proposal, uncovering immunosuppressive drugs. I think this makes sense as a way to increase the benefits a transplant provides. This proposal also challenges the requirement that the transplant is done in a Medicare-approved facility for someone to be eligible for coverage. The justification for this is that the experience centers and doctors have more success which increases the chance a recipient will benefit and that's the same justification that's offered to support extended drug coverage. So I'm not so sure I want to say get rid of that requirement. I would support a requirement that questions the centers that do the transplants without being accredited or approved by Medicare to put people in that situation. But I think the requirement itself may be a good one. Finally, just some general observations. I think it's very important to protect the integrity of the transplant system. These policies — living donation is already a growing phenomenon. It's amazing how much it's increased just in the past couple of years, especially the stranger donations. So if these kinds of changes were to increase the number of people who feel comfortable volunteering, clinicians screening donors will be under more pressure to maintain standards. I know some people, for example, at the Cleveland Clinic they used to, and I believe they still have a kind of a bioethics screen where people from the bioethics program, the clinical ethics program talk with the donors about what they want to do and try to assess voluntariness. This is in addition to the psychological screening. And also the recipients, about whether they'll be able to take care of themselves and handle having an organ. And I know some people have told me they just feel so much pressure to pass the person, to say "yes, you're okay, you're good to go." And these are soft criteria they're applying. So there will be more situations like that and more challenges, I think for the screeners, the more this living donation occurs. I also wonder about decisions about a recipient's ability to benefit from a transplant. If somebody has a friend or a family member or a stranger who is willing to donate, will physicians be more willing to say "yes, you can benefit from a transplant," than they would be if they were just listing them on the list and they were determining ability to benefit from that distant, more anonymous perspective. So I wonder about that. I read something by Julie Inelfinger in the New England Journal on living donation, and she said that the first living donor transplant team said that organs from such donors should be used only when a triple principle on a standard of care was applied. First, the likelihood of success for the recipient is high; the risk to the donor is low; and true voluntary consent is obtained. And she mentions that even people working in the field now say this is going to be more and more challenging to maintain this triple principle as the supply of living donors increases. So that's tangential to these proposals, but I do think the intent is to make more people feel comfortable about donating and so they could increase the supply which would be a good thing, in many ways, but raise these concerns to a greater degree. That's all I have to say. DR. PELLEGRINO: Thank you very much, Rebecca. Before opening up the paper to discuss, let me read an announcement we've been asked to make by our audio-visual technician. The use of cell phones and/or blackberries will affect sound system and recording causing static. Thank you. I hope you will all observe that. Now, does anyone wish to open the discussion? Thank you, Rebecca, for being specific and taking each of the proposals and looking at it critically. Anyone? Dr. Eberstadt? DR. EBERSTADT: Rebecca, thank you very much for that kick off on this very thorough and interesting staff discussion paper. Let me just talk very generally about these proposed recommendations. This morning, we were wrestling a little bit about the whole question about whether there should be a marketization of human parts and like it or not, these proposals all involve a move towards the economization of organ allocation process, kind of an explicit attempt to harass economic forces in a benign way towards this human and medical problem. To the degree that they do so, this brings into question or forces us to revisit the whole question of the nature of the gift, what sort of a gift is organ transfer supposed to be, what sort of gift should it be? It raises questions about that, obviously. In a much more kind of narrow and nerdy econometric or economic way, we can say that none of these are proposals that come without economic costs, even the one which — the first one which suggests that there simply be time off from a job. That entails costs for an employer. Replacing an employee is not a costless, seamless transaction or procedure. Four of these proposals would use economic forces to change the cost benefit calculus in such a way as to try to encourage more supply. The fifth, however, would change economic, the economic calculus in such a way as to increase demand. You might just notice we've got some proposals here which would tend to reduce the existing shortage and other proposals that would probably, all other things being equal, and tend to increase or intensify the existing shortage. DR. ROWLEY: Mike, could you give examples of the latter? DR. EBERSTADT: If the costs of being a recipient are reduced, that's probably going to increase the demand for being a recipient. DR. ROWLEY: Fair enough. I understand that, but you also had the converse, it seemed to me which is the costs will make things worse. You're saying that it's because there's potentially going to be more recipients, the list will get worse or longer? DR. EBERSTADT: All I was suggesting is if you do things which, all other things being equal, increase the supply, shortage can be expected or guessed to mitigate; if you do things which all other things being equal, increase demand, an existing gap can be expected to increase in size. That's all. DR. PELLEGRINO: Other comments? Leon? DR. KASS: I'm — this is a thought from the middle of the stream. First, in part, to — something which Nick said at the opening, these are — at least four of these are meant to remove the impediments from the likelihood of donation and while there are financial considerations here, they could either be said to be some kind of — not quite a reward, but a removal of the penalty for a gift, rather than simply an outright compensation which would turn the gift into a product or a good exchange. I mean there are fees for services. There are rewards for gifts and then there are payments for goods or products and this — while some of these things might produce the kind of incentives that begin to look, or would at least require the change in the law as the writing points out, I don't think that necessarily this is part of a slippery slope towards the full economic commoditization of this business. That may or may not — as an empirical matter be true, but it seems to be a philosophical matter where one could defend these distinctions. I don't know — we start really with this organ business and Rebecca alluded to the fact that here we're asked to take this matter up, extract it from other forms of medical expense and for other kinds of needy matters. That's unavoidably the way things come to us. It's certainly the way the legislation gets introduced and you're either for it or against it or you have something to offer. But one can't help but think as one reads this about why one would single out these particular uses, particularly of tax money, to put behind this particular set of removal of disincentives, rather than other areas? You could make the argument that you're doing this because we think, as the 1984 law seems to suggest, that the nation as a whole has an interest in the success of transplantation. But this has been singled out for special attention as a public health matter of national importance. I'm not sure if one had to revisit that that one would argue for it or one would argue for singling out dialysis as the one kind of entitlement. That's where we are. That's gone. But the other argument for doing this would be to say look, in purely economic terms, this is a matter — this is the way of saving money for the health care system which if every transplant is that much saving over chronic dialysis and that much provision for comprehensive drug coverage for immuno-suppressants, pays for itself if the people actually stay on it. So I can see that. And maybe that should be enough for me, but as a moral argument, and some of the moral arguments that are made here, curiously enough, it's the practical arguments that are more likely to sway me here than the moral ones, especially when I wonder about what is sort of selective about this area that we should be somehow singling it out for an infusion of federal funds, federal tax credits and the like. And that's just I think a puzzlement for me. I don't — I can only state the difficulty. Reading each one of these things in the abstract from everything else, okay, this is reasonable, or I'm not sure that we have to provide advance insurance for everybody who wants to take this kind of a risk. Being an organ donor is a risky thing. The risk might be very small, but I'm not sure you have to ensure somebody who is going to go through this thing that if something happens with their care, certain moral principles have said it's morally irresponsible to allow someone to do this, if they don't have health insurance — I am not sure it's morally irresponsible. Somebody might elect that kind of choice, to give an organ to loved one even if they don't have health insurance. I sort of have trouble putting this together in the larger kind of context which we've for the moment bracketed. I'm sorry. DR. PELLEGRINO: Gil and Peter. PROF. MEILAENDER: One of the problems that I have thinking about this is related to some problems we had this morning in the sense that about some of these things you're just not quite sure. You know there are some considerations that might tend one way and other considerations that might tend another. If you bracket the fifth proposal which is a little different here, and you think about just the first four, they're all intended... they're increasing steps intended to encourage or maybe — encourage or help people be generous, something like that is the way they're couched. And one of the things that I just can't quite make up my mind about here is if these steps were intended to encourage people to be generous with respect to donating to relatives, say or something like that, I have one sort of reaction to it. But these steps are intended to encourage people just to sort of donate to strangers, kind of. I have a somewhat different reaction to it, but I presume that these steps would be, enacted this way would be intended to encourage just anybody and everybody to donate. And that's where I begin to have problems. I'd be more inclined to favor it in a more restricted way, but I don't know if the law could restrict it. I sort of in my own mind split the difference when I said well, the first couple seem okay and the three and four I'm not so inclined to. I don't think there's any great philosophical justification for splitting the difference in that way other than I have this sort of reservation about just encouraging the kind of generosity that just thinks of one's body to be donated to anybody and everybody. And yet that is the kind of encouragement that's at work here. So there's a puzzlement there that I can't quite get through. DR. PELLEGRINO: Peter? DR. LAWLER: If there is a moral imperative here and I agree it's quite questionable is that we should do everything we should do short of organ markets, if we're not going to be for organ markets. So we're in favor of doing everything we can do to increase the supply of kidneys given that organ markets we conclude is a cure worse than the disease or the prices. You can't say about the generosity that the generosity involved here is giving up the kidney which is pretty generous, all things considered. So you wouldn't want to add to the generosity of giving up a kidney, financial generosity, given that some people are much more able to bear financial generosity than others. So understood as a theory, the tax credit, the leave and all of that would allow everyone to be generous in this sort of way and not only those who can easily leave their jobs and those who are fairly well-heeled and for whom the cost is no big deal. So I agree that it seems perverse as a method of encouraging generosity to strangers and donating live kidneys in a kind of undirected sort of way, but whether it's directed or undirected, as Gil points out, you can write the law to make that distinction and I'm not sure it's so bad to tell people that we appreciate your generosity, we're okay with your generosity and so we don't want to add to your bodily generosity, so to speak, financial generosity which in the nature of thing would be unequal — none of this stuff is required for rich donors, but if you're poor and generous, you might have to have some of this just simply to be able to do it. You can't allow your generosity to ruin you. So the tax credit and the leave seem the most benign ones to be — the insurance seems more problematic because I would like to see more detail about how much this would actually cost and all that and then I agree with Gil, the number five is just an immuno-suppressant drug coverage. It's just a question of prudence or practicality. We get more bang for the kidney if we have that and we'll save the Government money. I don't think there is a deep moral point for that one actually. DR. PELLEGRINO: Thank you. Yes? DR. GÓMEZ-LOBO: In a way, I was very much impressed with Janet's last remarks this morning and I think that's a very important point. It actually relates to what we're discussing now. My first reaction when trying to make up my mind on these five proposals was how much do they cost? In other words, given the important notion of opportunity costs, I mean what would be detracting monies from if these proposals were endorsed. And it seems to me that the reply is we don't know how much they would cost. I don't know if they can tell us if there is any likelihood that people could calculate these costs one way or the other? DR. PELLEGRINO: In principle, sure, you could come up with estimated costs on all of these. DR. GÓMEZ-LOBO: On all of these, okay. Well, and then the question is until we have those estimated costs, what should we, as a Council, recommend which comes back to the lack of empirical knowledge of some of these issues. Now my own sense of that would be that any set of recommendations coming from the Council would have to be formulated in very general normative terms so that say if there's a morally compelling case for say doing away with considerations of geography, now I'm not quite sure. I heard some very important arguments this morning, that it should be really a recommendation for UNOS and assuming that they are the people that are socially committed to having as much as one can know about this. So basically what I'm trying to suggest is we have two routes. One would be to go all full speed into an absorption of the empirical data, but I don't think we have the strength for that. Or the other one would be to frame it, to try to identify the moral issues in such a way that the recommendations would be recommendations to another institution which would have to try to match their decisions to those norms, but under the important restrictions of costs and practicability. DR. PELLEGRINO: Thank you. Dr. Rowley? DR. ROWLEY: Well, this isn't — I was just going to ask a matter of education, but following up on what Alfonso said, and partly what I said this morning, it seems to me that the one dimension that we can add to this discussion, the national discussion is looking at the alternatives and if you will, not so much passing judgment, but just making some observations on the moral and ethical framework in which these are discussed. So for instance, in this chapter, rather than coming down in favor of any one of the five, we could say that we've considered them and that the ethical issues that have to be included in a final decision are things that we have discussed and things that are written in the paper. Now that's a cop out in one way, but I think you can also argue that it's being honest in that there are a number of issues that we really don't have the competence or the basis to come to a judgment. What I really wanted to do was have somebody explain to me, various bills have been introduced into the House of Representatives and I understand that many bills are introduced and nothing happens to them. Can somebody just explain to me why these bills apparently went nowhere? What are the arguments in Congress or was it just lack of anybody pushing them that they just were not forwarded for a vote? DR. PELLEGRINO: Anyone wish to respond to that question? DR. CROWE: This will be very brief, Dr. Rowley. I think most of these bills went to specific committees that we're going to be dealing with them and at that point it's a political debate. So the Committee can say yes, we'll talk about this later and not get to it. I don't think that, except for one section that went to the floor of the House or something like that where they actually had real discussion or in the Senate. DR. KASS: Were there hearings on any of these, do you know? DR. CROWE: Not the ones that we're looking at in this session. The later session there seems to be more interest in paired donation and that was raised again in this Congress. DR. FOSTER:I want to ask Nick a question because I don't know much about economics, but there was a very interesting series after Christmas about retailers and gifts at Christmas. It's a huge amount of gifts and how they have changed their mind now that most people really don't want gifts. They don't fit. They don't do everything else and so they're now changing their view that what you're going to give is money. You're going to give a card worth $50 to a hardware store or so forth. In other words, in the end only money counts, not markers for money or not excuses not to give money, but money. And so first place, I want to ask if that's — if you think that's a — I just read it in The New York Times. I mean do you think that's a fair statement and then I want to — I'll make a comment here. DR. EBERSTADT: You can always do more with the gift that has the Franklin on it than the gift card to the store or other things. There are more options there. DR. FOSTER:Okay. It seems to me — this seems to be part of the idea of trying to increase the supply of organs which we're going to discuss at the next session. And the most important thing will be on the issue of a marketed system which is there. If you're going to be serious about doing this, then to me, instead of saying well, I'll give you a life insurance policy and I don't know how much that's going to cost us, but the 20-year-old donor and so forth like that, that you shouldn't include this in the cost of living transplants. That is to say, that you're going to give the donor a large enough amount of money for the organ to be given that it would comprehend any possible hospital costs and so forth of that sort. You're not going to do that for a thousand dollars, but you probably could do it for — I don't know, kidneys are probably $60,000 or $70,000, there are different places. But for $25,000 — you know. So it seems to me that in one sense, this whole chapter is a way to avoid the appearance of paying for organs but at the same time to give some sort of indirect monetary component for the giving. It looks like to me that this really is a substitute for — because then we don't lose the human dignity or anything else because we don't have cash, it seems to me. DR. PELLEGRINO: Dr. George. PROF. GEORGE:Well, I am really inclined to just say Nick, what's the answer to that? Because that's really my question as well. I'm wondering, Nick, if any rigor can be put into the distinction between removing — what would the word be? Side disincentives? Yes, side disincentives to generosity and paying somebody for the widget or whatever it is; in this case, organs. Is that just a shaky, soft fluffy distinction or can any rigor be put into that? I have another comment after this, but I wonder if Nick could just reply. DR. EBERSTADT: I think that if a Nobel Laureate like Gary Becker were here, which I'm decidedly not, he would have said that Dr. Foster has just cut to the chase. And that — someone like Gary Becker from his blogs and from other writings would say that this is exactly the question. Why mimic the workings of a market when you can have the real deal there? That would be — I think that would be Gary's argument there. As far as attempting to estimate the impact, is that what you're wondering about, how well could one guess about the impact of these prospective sorts of measures without actually enacting them from other sorts of experimental — PROF. GEORGE:Well, let me try again, It's just kind of a flat-footed question. Is there a rigorous distinction, can any rigor be put into distinction between eliminating, using financial considerations to eliminate disincentives for giving, that's (a); and (b), authorizing the sale of organ like another product? Intuitively, just sort of at the surface level, it sounds like a viable distinction. But I gathered from what you said and what Leon responded to that you were suggesting maybe that's not a viable — it's a very fuzzy distinction. DR. EBERSTADT: We certainly have a great deal of empirical data about how financial donations, not more personal donations, but how financial donations are affected by changes in the tax code and changes in other sorts of incentives and disincentives. I think people can talk very confidently about that. The work that has been done to date on hypothesizing about an organ market as I think we discussed in some earlier sessions has to be pretty hypothetical and makes use of guesses or if you want to dignify the phrase a little more, bounded hypotheses about what sorts of elasticities or responses, different types of incentives would receive. And that's the sort of hypothesis that we've seen in the economic literature on this so far. So within a surmised range, I guess is what you'd say. PROF. GEORGE:Could we explore a little bit the considerations that Peter was putting on the table to give an organ, just in a pure donation system, to give an organ comes with some costs attached. Some people would be able to afford those costs more easily than other people will be able to afford them. If we took steps simply to put people who can't afford them into the position of those who can, would we simply be sliding into organ donation? I'm sorry, organ commodification, into treating it as a product with a price, monetizing it? DR. EBERSTADT: My first reaction would be to suggest that we'd be moving closer to that. We wouldn't be monetizing it, obviously because there wouldn't be a market in organs. What we'd also find, I think as Peter indicated, is that for any given sort of credit or bonus, we'd have a sort of a regressive response. People who are better off would be less incentivized than people who are less well off, like any other sort of bonus or standard sort of bounty. So there would be a certain sort of regressive impact that one might also expect. PROF. GEORGE:And if I could just make a comment on a different subject. I just wanted to reinforce what Janet said. I thought it was a very persuasive point, especially building on what Peter had said earlier. It seems to me just as a general matter that where a judgment of prudence is controlling a decision or even a judgment of preferences, about say, how we're going to spend money, is controlling a decision about a policy where you're prioritizing goals, for example, for the purpose of deciding how to allocate the public resources that are available. I don't know that it is our Council's role to do that, or whether we ought to be doing that at all, and it seems to me that's because our judgment in that area really won't be a bioethical judgment. It's not a judgment about ethics at all. It's the kind of prudential judgment that we pay elected representatives to make, but not necessarily on the basis of ethical or bioethical concerns. Now having said that, once a policy proposal goes on the table, we vote it up or down, but one could be voting a particular proposal down for two reasons. One, one is opposed to the proposal. Two, one isn't necessarily opposed to the proposal, but doesn't think that this body ought to be making a recommendation. So I think that it might be with some of these proposals that if this Council decides that we don't want to endorse the proposals, we should make clear or those of us for whom the question is a jurisdictional one, as it were, should make clear in casting the vote that we're not saying to Congress, don't do this, it's a bad idea. DR. PELLEGRINO: Professor Schneider. PROF. SCHNEIDER: I'd like briefly to continue that line of inquiry by suggesting that it's a sobering thing to go back and look at the kinds of recommendations that predecessors of ours have made; recommendations that are old enough to have been put into policy and contested. And I think that in the areas of bioethics that I know anything about, the record is humiliatingly bad, that people were able to make recommendations that they thought were based primarily in their moral understandings and that seemed so plainly right and good that no decent thinking person could object to them. And that's how we've gotten things like the Patient Self-determination Act, for example, which requires institutions to tell their patients about the existence of advance directives. We have had recommendations for Living Wills, ideas about informed consent for research subjects and for patients. And when you look at the empirical record that evaluates all of these sorts of things, the expectations that groups like ours had for them have been almost systematically defeated. And that's partly because the groups making the recommendations just didn't understand what the empirical reality was, which was always much more complicated than anybody expected. It's also because the moral arguments are always much more complicated than a group like this could deal with, particularly because we tend to fixate on the moral argument that seems most important to us, forgetting what we actually know which is that all moral arguments compete with other important kinds of moral arguments. It's extremely difficult to anticipate how that kind of conflict actually works itself out in real life. Now the trouble with what I'm saying is that it's very discouraging for a group like this that feels assigned to go out and make recommendations about public policy. But I worry, on the other hand, that we've now launched ourselves into a project of giving the country advice about transplantation, and we feel obliged to say something, and I think that that is an impulse that should be resisted, if in fact, we can't say anything that's reliably useful and at least better than groups like ours have done in the past. DR. PELLEGRINO: Rebecca? PROF. DRESSER: I think it's more complicated than that for some things. For example, the Patient Self-determination Act. I don't know how much the passage of that had to do with people in bioethics. That was a very popular proposal in Congress. And some of these other things we're talking about are proposals in Congress, so that will be perhaps voted up or down or reintroduced and reintroduced. And so do we have a role in commenting on proposals that Congress is considering, is there any light we could shed on what they're thinking? Or do we have — should we just stand back and let them make all these decisions without our considered advice? We probably think that would be better. I mean we have various policy making groups. I mean who knows if this is going to go forward with some of these things or not. Do we have a role in weighing in or should we just raise issues and say these are various considerations or should we stay out? I guess that's a question for us. DR. PELLEGRINO: Gil? I'm sorry, go ahead, Gil. PROF. MEILAENDER: This follows up sort on Carl's question, but then takes it back to the issue that Dan had raised and that Robbie was pursuing. There would be a couple of ways to think about these proposals here. One is just as proposals on which we might weigh in and offer advice and that's where your concern about — especially whether we have anything useful or knowledgeable to say needs to be taken seriously. They do also, just taken as a package, raise the more general consideration which is what Dan had started pushing and then Robbie was trying to formulate about whether there is actually some kind of serious difference between simply removing disincentives which is how these are packaged, kind of, and on the other hand offering financial incentives which unless you're prepared to go whole hog, we don't want to do. So in other words, can one reasonably make that distinction. Now I don't know, but at least I want to take a crack at formulating what it seems to me you were pushing, Robbie. If you remove a disincentive and I then give an organ, donate one, then I'm not any better off than I would have been if I hadn't given the organ. If you provide me an incentive and that gets me to donate the organ, then at least in principle, I may be better off than I would have been had I not. I think that there's some sense to that distinction although you may be able to destroy it. But insofar as it is, there's the specific question about each of these five things, is it a good idea or is it not a good idea. There's also the more general question, if whoever had responsibility for redesigning the system or tinkering with the system, wished to remove financial disincentives or various kinds of disincentives, mostly financial in these sorts of ways, would that amount to the same thing as offering financial incentives. That's the sort of question that we could answer even if we didn't think we had the empirical evidence to respond to these, maybe. DR. PELLEGRINO: I have Leon and I have Diana. Is it on this point, Diane? Okay, do you mind, Leon, hold on a second? Diane? PROF. SCHAUB: I guess it seems obvious to me that there's a difference between making money on an activity and not losing money on an activity. If your mom wants you home for Christmas because she wants you to share the gift of your presence, and you're a poor graduate student and she says she'll buy the plane ticket, that's removing a disincentive. It seems to me completely different from — PROF. GEORGE:I'll buy you a car if you come home. PROF. SCHAUB: Well, no. The plane ticket all you get to share is your presence, right? PROF. GEORGE:You're saying it's different from saying — PROF. SCHAUB: Yes, it's not a bribe to come home, it's just removing the financial disincentive. DR. PELLEGRINO: Leon. DR. KASS: This is partly to Gil and to Peter and partly an invitation to get something less depressing from Carl. (Laughter.) PROF. SCHNEIDER: Good luck. DR. KASS: It's true that we have talked about these proposals as removing at least four of them, of removing disincentives to donate and maybe it's true, Peter that these are proposals that are eagerly embraced by people who don't yet or may never want to embrace the markets and Dan might be right that to the extent to which these are baby steps in that direction and they're not really going to make the difference, why don't we have the fight over the other. But I note that the title for this section is care for living donors and transplant recipients which isn't simply exhausted by whether or not there are going to be incentives, disincentives, but what is it that we as a community that have chosen for better or worse to encourage this activity owe to those people who are sufficiently generous to put themselves at risk and do we have some kind of obligation, (a) that they not as a result of this, wind up being penalized or at health risk without some kind of support, etcetera. Some of these [are] more like removing disincentives. Some of them look really much more like making sure we care for these people. And similarly, if you're going to do a transplant, but you're not going to pay for that which would make the transplant efficacious, are we behaving properly, having these people. It seems to me those can be taken up as questions about obligations to donors and recipients, even if they don't affect their incentive. Even if they don't affect the decision to give. That's part of this. I wouldn't dissent from your overall judgment on recommendations of previous Councils or of this Council. You can't blame this Council for doing terrible things because no one has paid our recommendations any attention whatsoever, at least not yet. So we don't have to do penance, at least on that score. But when there are people offering various kinds of proposals, along these lines, without necessarily embracing this one or that, where we lack the empirical knowledge or we don't give perhaps sufficient weight to the competing world principles, is there not something useful here to be done as these particular proposals have been grouped? Let me put it more pointedly. Here is staff working paper three on this particular heading. If it were up to you, would the discussion of these things simply not appear in the report, what we say on the one hand this, on the other hand that? And on the fourth and third hand, we don't even know what to say? What's the — having taken your caution, what's the practical upshot with respect to the materials that are now here? Other people are making these recommendations. We might not be able to make a judgment as to whether we can afford them. We might not get to the bottom of all of the moral arguments, but are we even suitably chasten to be sort of impotent to say anything at all about this or what? What's your recommendation? PROF. SCHNEIDER: Well, I get to respond. Well, first, I very carefully phrased what I said to exclude any product of this commission or council so far because we haven't lived long enough to see how its proposals work out and what effect they have, and in fact, one of the things, it seems to me, possibly to distinguish the product of this counsel from its predecessors is the high intellectual quality of the work that's been done in the reports. Whether that makes them better proposals remains to be seen. One of the things that strikes me, as I listen particularly to you talking about our choices is that we repeatedly discovered that we're working against a highly irrational background and, particularly in the way that the American health care system works, particularly the highly irrational and morally deplorable fact that we let 42-some million people not have insurance. If you had a systematic insurance program, a lot of the problems that we're talking about in this particular part of the document would go away. I must say that the particular proposals in this particular section appeal to me a great deal as a matter of intuition, but I think that we're acting in a very uncertain situation in which we have very uncertain competence, and left to my own devices I would say that this has been an interesting discussion, but I'm not sure that we are really ready to give the country advice on this particular topic and that there are other topics where we could be more useful. DR. PELLEGRINO: Dr. Hurlbut. DR. HURLBUT: Leon introduced the question of whether this is all motivated, at least part motivated, by the previous policy decisions concerning kidney transplants and dialysis and so forth. So one thing I'd like to be clear about, what are we talking about here? Just kidneys right now, or are we talking about all sorts of transplants, in which case where will be draw the boundaries between a kidney transplant and, say, the hypothetical wound transplant. We've got to be careful not to establish policies that will edge over into things we don't consider direct and immediate lifesaving procedures. But with regard to kidney transplants, for a range of reasons, all the way from personal to economic reasons, I think that some of the suggestions in here seem good to me. They don't seem like valuable consideration to me. I think some kind of catastrophe coverage, maybe even something that was like life insurance if you did die, giving a life saving organ, and something that would cover immediate sequelae, even long term if there was really a disaster. That seems pretty reasonable to me. I think the other forms of compensation are also important, and it strikes me that in some cases the very donors are going to be from families where there's already an economic burden because of the illness of the family member, and it seems compassionate to extend these concerns, specially if it's good economic policy for a country. You know, it's that extra thing that makes the gift possible. But I think there are a couple of things missing in this equation. I think we owe it to our society not to just pass this off with a low grade statistic about, well, there's this percent mortality and immediate morbidity. I think we should also call for long-term studies to see what the consequences of donation really are because you don't have two kidneys for no reason at all. You have two kidneys perhaps because in a natural environment there's a lot of infections and people lost kidney function progressively. And it's true with antibiotics we may have prevented that. It may be one of the reasons why we're living so long. Is it absolutely clear, Dan? Is it absolutely clear you have equal function with one kidney long term? DR. FOSTER:Pretty close any way you can measure. Even the mass is the same of what the kidneys were from the MR size and so forth. As far as I know, there's no difference that it does. And I don't know if anybody knows why you have two. If you're going to try, if evolution was trying or whatever, if the design or whatever you want to use was going to make two organs, you probably would make two hearts instead of two kidneys. I mean, kidneys are — (Laughter.) DR. FOSTER:So maybe the designer made a mistake. I don't know, but — DR. HURLBUT: Then you could really give away your heart at no cost. But I do think it's worth keeping our eye on it, and I think we should make some small reference to that. I also think that since there are places where there are laws already that allow this kind of compensation we should find out if there have been any studies to the effect of those laws. Have they, in fact, increased donation? Are there, in fact, feelings within the community about those laws and have they been dealt with as though they were some kind of valuable consideration? Also, I think it would be interesting if somebody would do — and maybe they've already done this — long-term studies on the feeling among donors and maybe even recipients about this procedure. Has anybody studied to see whether donors have donor regret later on? Because one of the things we're doing here is we're making it a lot easier to give, or hopefully a lot easier to give, but I think — I'll say this in the next section as well — I think we have to be very careful not to put pressure on people and also not to make it just seem —I don't know. It's funny. It's such a strange area — careful not to edge this over into being too much expected somehow, sort of the expected thing to do. I think it should remain as a — I personally think that the donor quality of this is a very important part of this to make it moral, and I'll say more about that, but I think we have to be very, very careful not to put it into a situation where people can say, "Hey, look. There's no down side." If you'll notice, if we take away every excuse to say no, you put another — I don't know. DR. FOSTER:I just want to make a general statement. Carl, I was a little surprised about some of the things that you said, that all of these things have been disasters, including... IRBs. I think without the Belmont report and so forth, I mean, we would have an entirely different world. Now, the IRBs don't function well. Everybody knows that right now, but without them, I mean, I think that generalization is a poor one, and I'm not sure that despite all we've heard here about IRBs, and I know you talk about that, too, I mean, I don't think all of those things are as disastrous as you have said. I think they came along and things changed and we find out that we've done it less well. So I would not be nearly so pessimistic. And the second thing I want to say is that it has sometimes been said, almost in a pejorative fashion, that this Council doesn't live in the real world in the sense that we have our own lives. Most people on the Council have been pretty distinguished and I would say that it would be a tremendous advantage to have wiser people who have studied and looked at things and have the time to sit and discuss, that no Congressman in the world is going to have time to do. And even if we make some general mistakes, and I agree with Leon; I don't think anybody — I told Mr. Brown who was listening in on writing a thing about the Council here that 99 and 99.99 percent of the people in the United States have never heard of this Council, you know. But to me, I would take pride in the fact that you have wise people who are bringing up these things. Instead of saying, "Well, let's don't say anything because we don't know what's going on in terms of economics and so forth and so on." So I've learned an enormous amount about myself from colleagues even when I disagree with what they say here. And if we're not going to say anything, then we've spent months and months talking about a subject that has been before us and everybody said, "Well, let's go ahead to do something." And so I'm not too much in agreement with that assessment, regardless of how this comes out. And the last thing I would say is that even when you have wise bodies discussing this subject, if you ask me to make a choice intellectually on what we have done here compared to what the IOM reported in that document, which was so bland that you could see nothing in it, I would take, even if we didn't edit it, what we've talked, just the transcripts here compared to the IOM report on transplantation. And I'm a member of the IOM and I respect them and all of that sort of stuff, but to me they just punted on everything. I'm probably speaking more forcefully than I should, but you get the point anyway. PROF. SCHNEIDER: This is not a place where I can give you the kinds of evidence that seem to me to be quite important to take into account when you're evaluating things like the work of IRBs and trying to figure out what the world would have been like without IRBs, for example. DR. FOSTER:Excuse me. I mean, I just want to be sure. You think it would be better off without IRBs? PROF. SCHNEIDER: I didn't say that, although I am working on an article that sees what happens if you make the case that the world would be better off without IRBs on a cost-benefit analysis, considering how much they cost and considering the fact that even before IRBs there were lots of ways in which the kinds of research that was done was controlled. Sidney Helprin has just written an interesting book on what the world was like before IRBs, and it's, I think, not a bad starting place for thinking about those sorts of things. I also think that it's difficult for a group like this to try to think very freshly and interestingly about these sorts of problems because the context has already been so well developed. I'd be interested, for example, in suggesting that it would be nice if the federal government stopped trying to regulate this and let states experiment with it in a Brandeisian sort of way. It might be interesting to see what would happen if you had a state that was willing to run some of these experiments all by itself so that the rest of us didn't have to follow and see what kinds of consequences flowed from that. PROF. MEILAENDER: I've been thinking about just sort of where this conversation has gone, and I just jotted these down. It just seems to me as if there are at least the following four things that we probably mostly agree on. Now, as soon as I say it, somebody will dissent. I understand, but different people have said these things, but let me just try it anyway. It seems to me that we probably all agree with what Bill Hurlbut said before, that more long-term knowledge of effects on donors would be good and would help us make wise decisions in the future, and that, you know, we should try to get that knowledge. We probably all agree — this is to pick up sort of on the way Leon formulated things a little while ago, and I mean, I think it may be wise to put this statement hypothetically — that if we are going to continue to be a society that encourages people to be generous in this particular way, donating organs, then we probably owe them certain kinds of concern or care. So that if we're going to do that, then it follows that we owe them certain kinds of care, and proposals at least one through four here are examples of the kinds of care that some people at least have argued we might owe those whom we ourselves have encouraged to be generous. And the third thing is if someone then wished seriously to propose one through four, and maybe we're not the people quite to do that, you would have to cost them out in a way. You'd have to actually prudently figure out what's involved and what kind of a commitment you're actually asking someone to make. I mean, all you know up until now, in terms of my second point, is that if we're going to encourage people, then we ought to try to care for them. We obviously can't do everything we could, and so we'd have to know what we were proposing. And then the fourth thing that I think maybe we'd agree on was sort of what I tried before, that if any of these first four proposals were affordable and cost-effective, then simply caring for potential donors in these ways by removing impediments that might keep them from donating would not amount to offering them compensation or financial incentives. Now, again, that doesn't recommend exactly any one through four. It just says that if folks who worked out the thing thought that these were effective ways of caring for donors, they would not, in a sense, have transgressed the line that separates removing impediments from offering compensation. I have a hunch that we more or less agree on those four things. Now, that doesn't make a report, but it seems to me it makes at least part of what one might say under this section of the report. DR. PELLEGRINO: Professor George. PROF. GEORGE:Abstracting from the particular proposals that we have before us, I think it's important to remember that there are three different conceptions and not just two of how we might approach this, how we might conceive our own role. One would be one I gather that Carl is advocating, to say, "Well, look. There's not a very strong likelihood that we can make a useful contribution here. The best thing to do would be to say that this has been an interesting discussion and not say much in the way of policy recommendations, especially in view of past experience with these councils and so forth." The other would be to conceive ourselves as a kind of blue ribbon commission. Sometimes executives or legislative bodies appoint blue ribbon commissions and say, "We don't have time to deliberate about all of the details of a problem and possible solutions. Therefore, we want to get a group of distinguished people together with various types of expertise and then they should propose to use solution to the problem, how to win the war in Iraq, how to get out of Iraq, or how to solve the problem of having 40 million people without health insurance," or something like that. Their brief and their charge is a general one. Solve this problem. The third, that I just don't want to be overlooked is what I gather, what I took from — Janet can say whether I did it rightly or wrongly — I took from Janet's comment, which is a more modest one, but not one that goes down Carl's suggested path of really not saying anything, and that is to pick out the specifically ethical aspects of the various possible proposals and the aspects of the problem on which ethical considerations bear and do try to say as much as we can about those. But once we've shaded off into problems that are of a prudential nature where ethical norms and judgments don't really control them, well, then we just step away and we don't try to solve the whole problem. We don't try to function like the Baker Commission on Iraq. And for what it's worth, my own preference here would be to go in Janet's direction, where I take Janet's direction to be that third way. Have I got you right? DR. ROWLEY: Yes. DR. PELLEGRINO: Paul. DR. MCHUGH: I've found this conversation very interesting, but I very much like the staff's report because it fitted into the things that we said at the beginning really of today, that at any rate we could all perhaps agree that this was a gift, and if we begin, we're talking about gift giving and not selling. Then the principles of how to manage it are very familiar to me and perhaps familiar to many of you in university life where we're working with people and trying to encourage gift giving. And there are three things that go into it, and they've all been mentioned here in one way or another, but there are only three, and they're encompassed also in this report. The first one is you want to remove disincentives to making the gift. Okay? The various formats that people give now so that they hold the money until they die and various kinds of things, removing those incentives so that they don't feel poor at the moment. Secondly, you care for them during the giving process. You care for them. You show them around the campus. You introduce them to Dan Foster, and you show the wonderful work that he's doing, and in the process, as well, you make it easy for them during the gifting. And then third thing you do afterwards is you steward the gift. You make sure that you remind them of what they've achieved. You show them the new and wonderful work that Dan is doing and things of that sort. And similarly here. We are removing disincentives of the money. We show care through the process, and we steward the gift by providing the medications and other kinds of things to maintain the organ in place, and that's why if we begin with the principle that this is giving, then these aspects at least in this thing seem to fall right into place for me. You might imagine some other things that would attach to those three things, but disincentives, caring, and stewardship are the three things that are in this report. DR. PELLEGRINO: Thank you. Dr. Gazzaniga. DR. GAZZANIGA:Well, I probably should have another dinner party before I — (Laughter.) DR. GAZZANIGA:— roll out these ideas, but you know, just roll the camera back here a little bit here to the first session on this when we had two strong personalities in an unforgettable exchange about the problems, the problems stated, the great shortage of organs, and then lickety-split we went into possible solutions which was the markets with a person who did not elicit neutral reactions in anybody, and a surgeon who dealt with the matter in a certain way. And let's imagine now something else happened at that meeting, that Ben Carson was the surgeon who hates blood and who has ideas about how to generate organs. Let's imagine, actually Paul presented the free market idea. He somehow believed that for whatever reasons and has his personality of understanding; he feels your pain, a little vulnerability thing going. It seems to me then we would all — if those had been the original presenters and there was a sense of the problem and a sense of possible, "How do we get to the solution?" we would have carried out in the intervening time maybe some empirical work, some investigatory work, look at this community, hospital ideas, is it practical, is it impractical, and said it seems to me that basically what we've fallen into here is a document that has been one way or the other a UNOS document of ways of continuing the system and not really confronting the market, and we ran away from it. And we're going to have this at the last session today when we're all tired and, "Oh, no, forget the market. Let's go have a drink." (Laughter.) DR. GAZZANIGA:So all of this leaves in my mind, picking up on Carl's pessimism, that maybe what we ought to do, my suggestion would be to table it and to maybe have a subcommittee look at some of these things in a more — we have new staff, I understand — in a more methodologically aggressive way. Look up information; look at cross-cultural information that seems to me to be very relevant here, and so forth and so on; and become better informed. I remember Carl's comment from the last meeting. There was a wonderful phrase he used, "where we have glancing knowledge," and it has bothered me ever since he said that because I wonder how many things I only have glancing knowledge of. (Laughter.) DR. GAZZANIGA:But I have a sense from what's being said by many people here that we're not prepared to really vote on these matters or take a position. So that would suggest maybe more study, and that is how a lot, as you know, science progresses and how information is gained. DR. PELLEGRINO: Thank you. Dr. Eberstadt. DR. EBERSTADT: I donts know if this will be taken as a friendly amendment or an unfriendly complication, but let me throw it out anyhow. As immediate and relevant as the proposals before us right now are, it seems to me that we might look back 10 or 15 years from now at any sort of discussion of these particular proposals as remarkably quaint because technology and markets are moving very rapidly and very rapidly beyond this particular set of discussions. And with both markets and technology moving very rapidly, the whole question about the marketization of human parts and, as mentioned this morning, not just necessarily the permanent sale, but maybe the temporary rental of things, not permanent assignations may not seem so fanciful in a number of years. So the real deal here, I think, is the question about market forces and markets and how to recognize and how to deal with market forces. And my impression is, I may be quite wrong, but I'm not sure that we have any consensus on the Council about this, and as an additional sort of model to the ones that Robby was raising, I suppose you'd say that there's the kind of the Oxbridge Common Room or the court of law sort of template, which is to say you put up the strongest possible case that you can for a couple of different perspectives that are contending perspectives, and you hope that you do a public service by bringing different contending perspectives to the fore and letting an informed public learn and make their own decisions from them. That would be another way of approaching this. DR. PELLEGRINO: I think we've gone over the time for this session. We will have a break until 3:40. (Whereupon, the foregoing matter went off the record at 3:23 p.m. and went back on the record at 3:35 p.m.) Thursday, February 15, 2007
Session 3:
Caring for Living Donors and Transplant Recipients: Five Policy Proposals