THURSDAY, JUNE 22, 2006

Session 4: Organ Transplantation and Procurement—Policy Proposals

James F. Childress, Ph.D., Hollingsworth Professor of Ethics, Professor of Medical Ethics, and Director of the Institute of Practical Ethics, University of Virginia, and Chairman of the Institute of Medicine Committee on Increasing Rates of Organ Donation

Benjamin E. Hippen, M.D., Transplant Nephrologist, Metrolina Nephrology Associates, Charlotte, North Carolina

CHAIRMAN PELLEGRINO:   On the record.  We're ready to go.  For the last point of the afternoon, we move to the IOM report and various other aspects Dr. Childress will talk about.  I think it's especially important again in view of your question of what the IOM is doing and where we fit and I've asked Dr. Childress if he's be kind enough at the end of his comments to tell us where he thinks we might make a contribution knowing what he does about the IOM report and other aspects of this from his many other experiences.

Dr. Childress is the Hollingsworth Professor of Ethics, Professor of Medical Ethics and Director of the Institute of Practical Ethics at the University of Virginia and Chairman of the Institute of Medicine Committee on Increasing Rates of Organ Donation, a rather focused assignment, Jim.  We're going to ask Jim to take off and then we will ask Dr. Hippen to speak.  He's a transplant nephrologist.

We'll do what we've done in the past this day.  After they've made their presentations, then we'll ask one of our Council members, Dr. Schaub, to  initiate the discussion.  Jim.

DR. CHILDRESS:  Thanks very much.  It is a pleasure to be with you again and I very much appreciated the discussion that occurred in the last couple of hours and I've been asked to talk about the IOM report which just came out in May and then offer some comments at the end about some things having heard the discussion earlier today and having also looked at the transcripts from previous sessions of where I think there are some real opportunities for the President's Council of Bioethics to make real contribution.  Indeed, you may need to correct several things in this report, but there are some other things that you could also do as well.

I've been asked to limit my slides to 15.  So I have 45 and you have a handout before you that gives all of those.  The reason that I included all those is I wanted you to see the whole picture.  I'm not going to talk about the whole picture.  I'll give you a sketch of it, but then I've been asked to concentrate on a few particular areas that are more important for your considerations.

So this committee was sponsored by these institutes and received funding from them.  This is the makeup committee and again that's in your PowerPoint, our timeline.  Now the statement of task is more important, so I'll linger on that for a moment because any committee including the President's Council on Bioethics will end up in part doing something either directly related to or contravening the task that was given. 

We did try to follow the task and that was to examine issues surrounding different proposals that have emerged for increasing the supply of organs from deceased persons in particular to look at ways to increase rates of organ donation.  We were asked and this is not part of the slide to distinguish those that were controversial from those that were not so controversial and how do you determine what's not controversial and not.  They asked us to think about it in relation to basic American principles and values and once we identified something that was controversial to ask whether it would be possible to modify or alter those proposals in ways that might make them less problematic and then to consider specifically the impact of these different proposals on the nation's efforts, on public perceptions and especially on disadvantaged and disproportionate affected groups and to make recommendations about cost effectiveness, feasibility, practicality and the like.

Now we had several guiding perspectives and principles that we came up with early in our deliberations.  These are very broad, but I think important nevertheless and they are not so different from some of the appeals that came out in your earlier discussion, but your earlier discussion did focus more on some of the more fundamental or you might call richer ethical perspectives.  If we didn't start in the middle of things to use Gil Meilaender's language, we at least started thinking about sort of mid-level principles and values and how they might play out in assessing the different policies that have been proposed.  So first the common stake in a trustworthy system that we view this as something that's significant for everyone in the national community, it should be effective and it should be trustworthy and if the organs remain scarce, then the issues about fair distribution become very important.

In relation to your earlier discussion which emphasized altruism a lot, we emphasized a variety of acceptable appeals to organ donation for organ donation and our society has tended to focus on altruism as a primary category.  But I'll emphasize later, particularly in relation to living donors, that we actually don't know that much about motivation.  I'll come back and explain why that's the case.  Altruism is certainly one important motive, but there are a lot of other motives as well and we suggest that it's important or appropriate to appeal to all of those.

Then certainly one that's played a role in your discussion already, a notion of respect for persons, it can be stated in different ways but includes respect for the moral worth and dignity of each human being, the individual's right to govern what happens to the body after his or her death including a voluntary choice to donate or not, respect for the remains of human beings as represented in different cultural and religious traditions and practices and respect for the wishes and feelings of the family of deceased individuals.  All of those are relevant concerns.  We would like them in a particular way, but they are relevant concerns for thinking about different policy proposals.

And then finally a fairness, this has to do in part with background conditions but also a fairness in the policies both in the what we used to think about in terms of distribution of the benefits but also distributions in the burdens of decision making and I think that becomes important when we think about, for example, a possible policy of presumed consent with particular attention to the impact on disadvantaged groups, a concern that was stated clearly in the task that was laid before us.

Now only a word about this one since this was not one that I was asked to focus on but I think it's important to see the role this plays and why we did not make certain other recommendations.  This report can be seen in many ways as a conservative report.  It basically builds on existing practices and policies, progress has been made in practices and then suggests ways to move forward with those making various adjustments here and there.  The one area where it's radical is in calling for great increases in the use of non-heart beating donors as they are often referred to or those declared dead at using circulatory standards.

Now there has been as you've already heard earlier in the discussion considerable improvement in the breakthrough collaboratives in increasing the supply of organs in the institutions, some getting as high as 70 to 75 percent of donations from individuals who die in those institutions.  Now that's an important part of our perspective.  If we'd been able to achieve that much with the systems that we, that is those that have been involved in this have been able to develop over time, then it may make the need for, say, a regulated market involving organs from deceased individuals less important or some of the other proposals less important.  At least, we can make a lot of progress here.  So you have those in your handout.

Now the area where I think our report is radical and I'm presenting this in terms of the order  in the report and I believe you have a copy of the full report, at least a hard copy perhaps or on the CD, is we tend to limit our pool to those who are declared dead by neurologic standards and one estimate is 12,000.  They range from 10,500 to 16,800 but that's roughly the range.  So even if all of our practices were to great increase the rates of organ donation limited to this pool, we may still have problems given the kinds of increases that we can expect over time in the need for transplantation.

So you've already heard there are several ways to go.  We'll come back and talk about living donors later.  Our report did not address xenotransplantation or stem cell research or other technological possibilities of the future, though they are obviously important.  So we are in the United States using some donors who are declared dead by circulatory standards but these tend to be cases of controlled dying and we don't really know how many potential donors there are there.

For the committee, the largest area that was untapped since so many people die the old-fashioned way, cardiac arrest, they're according to one conservative estimate, would be an estimate each year of about 22,000 individuals several of whose organs could be salvaged after individuals had been declared dead by circulatory standards and in 2003, the possible number, it's not very clear, from that group was limited to 17.

So what do we recommend in this?  Here you have the terminology and you can look at that in your report.  We are focused, we said, on a continued controlled recovery order and where possible, from controlled or expected cases of dying but to try to get this untapped area of uncontrolled or unexpected deaths occurring outside the hospital setting and there's a lot we don't know about this area and so in part, we're recommending demonstration projects.

Now they ethically will choose their rights.  I will not focus on those related to controlled DCDD.  That is donation following circulatory determination of death.  That's the language we propose.  There is a lot of variety in the language relating to this area and others and whether this language will catch on or not is unclear. 

But just to say a few words about uncontrolled DCDD and clearly from an ethical standpoint, it's important that resuscitation efforts proceed in the field on the street until you're clear that the person cannot be resuscitated.  When you're transporting a person to the hospital, one of the big questions is going to be once you've determined that you cannot resuscitate this person what kind of consent is needed for beginning procedures to try to preserve the organs for transplantation.  If there is a registry and an individual is in it, if there's a signed donor card, then you can take that as consent to starting the procedures that will preserve the opportunities for donation.

If there's not, then there are a few states, Virginia and Florida for example, and the District of Columbia that do allow beginning procedures that could preserve opportunities for organ donation if you are able to locate the family and get consent.  If not, then of course those procedures stop.  But you can see the complexity here both logistically and ethically.

There are several steps we recommend and clearly this will include public education, professional education as well as critically excellent emergency and resuscitation care.  We proposed demonstration projects in large urban areas where there are excellent emergency and trauma services and facilities to see really whether it's feasible to actually obtain and transplant successfully a number of organs from these cases as well as again thinking about this in terms of maintaining opportunities for organ donation.

Now in terms of individual and family decisions to donate, one that I know some attention has been paid to here is the question of mandated choice.  At least, that's discussed in Eric's paper and we came to the conclusion while supporting various ways to increase public understanding and support of donation, increasing opportunities for people to record their decisions to donate and even stressing the role of statewide donor registries with nationwide access to those, that on the controversial topic of mandated choice in which you force individuals to choose yes or no or presumably you can do maybe or in a proposal that came out a number of years ago you could ask individuals if they wanted to designate a potential decision maker in your place, there would be a lot of possibilities.

But we felt that it is not appropriate at this time to pursue mandated choice.  Obviously, there are some concerns about individual autonomy though you could argue that this is a way to get individuals to exercise autonomy about what would happen to the organs after their death.  Timing of a current situation is that we tend to ask the wrong persons at the worst possible times questions they've never been asked and should never have been asked in our current approach.  So this would at least require on the part of individuals decision making up front.

Now we know that forced choice decisions  often lead people to choose what they take to be the safer route.  I think there are good reasons here to think that if we instituted mandated choice at this time, we would actually reduce the number of organs from deceased donors for transplantation.  Now part of that argument is that if you ask why people do not currently sign donor cards, some of those reasons have to do with inertia, with not having thought about it, but some of them just have to do with trust and mistrust of the system.  Insofar as those reasons are present, to force individuals to make a choice where they're worried about that sort of thing will tend to lead them to say no.  If they say no, they block familial decision making even though they might not have objected to the family making the decision.  So it becomes a block in terms of what might happen later and in our current context, it's not at all clear that this would be an effective way.

The first question the IOM Committee asked  about any proposal was would it be effective in increasing the supply of organs for transplantation.  Because if it wouldn't, then it doesn't pass the first test.  There are other questions obviously that have to be raised but this was the first one.  If you informed and educated the public to the point where this was acceptable, you probably wouldn't need to adopt it all anyhow as you probably through just the ordinary approaches we have would be able to get enough individuals to sign their donor cards or in a registry.  So our recommendation was not enacting legislation at this time requiring people to choose whether or not to be an organ donor.

Now presumed consent is another important topic and that language varies a lot.  You've heard from Robert Beech at an earlier session and you heard some of the discussion today.  I'd like to draw the distinction in the way the Institute of Medicine Committee drew it knowing that this is a contested distinction.  But I think one can distinguish a policy of presumed consent from a policy of routine removal or I believe as Leon used the language today "routine salvaging" or language used in Eric's report of "conscription."  And I think you can distinguish them in at least the following ways.

In routine removal, salvaging, conscription, the view is that the state or the society has ownership or dispositional authority over the organs of deceased individuals and it may take those organs unless, and in most cases, there is an option to opt out, it may take those organs unless there is objection.  Now that clearly is a top-down approach based on depositional authority over organs by the state or the society.

And that would be different from another approach which would be individuals and family members having the right to make the decision, having the dispositional authority those organs, determine access to those organs.  But in a situation where the society has made a determination that a silence, that is the failure to opt out, will count as consent.  Now there are a lot of contexts in which we do have silence or a silent consent or a tacit consent but in our judgment as a committee even though this could be ethically acceptable in principle, we lack the social/cultural conditions in the United States to implement this and so Bob Beech is right.

If you were to simply implement this tomorrow in the United States, then you have the kinds of ethical problems he noted.  It's not clear you would have those in all kinds of systems.  Furthermore, there are different versions of presumed consent and a list too there that weaken the strong versions.  It turns out in practice even the law in most countries where there is presumed consent even if the law doesn't require consultation with family members, in practice the procurement teams tend to do so in part to make sure that the individual did not opt out in circumstances not noted in some appropriate way.

And for this to be acceptable, we basically argue the last point on the last bullet here that you would have to have clear, easy, nonburdensome, reliable ways for individuals to opt out.  So if this were to be enacted at this time, it would be in many ways contravening personal autonomy.  We don't have the social, cultural conditions for this and we don't have the kinds of mechanisms that would be important.  But in addition, it would be counterproductive.

Like mandated choice, it would lead to a reduction in the number of organs available for transplantation is the best judgment we could come to.  Now that's based again on putting individuals in a situation where they don't fully trust the system that apparently exists and that would exist here with just the changes in the direction of presumed consent and it would be quite reasonable for them.  Indeed, you'd be very surprised if they did not choose to opt out in order to protect what they take to be important personal interest.  So we argued against adopting presumed consent at this point though we left open the possibility that you can move the society in this direction over time.  So that was our recommendation.

Now in terms of financial incentives and so there are two more parts to this, financial incentives and living donors, and clearly a number of proposals have emerged and you've looked at this in part directly, but also in part through Eric's analysis. And our basic conclusion I'll present now, and then talk a little bit about some of these, is that we should not adopt financial incentives at this time.  Now committee members clearly differed in part as to whether they viewed it as intrinsically wrong to adopt such incentives.

Others of us did not hold the view that it's intrinsically wrong, but felt that it could not be adopted in our society at this time because of a variety of other ethical concerns related to fairness, respect for persons and the like.  And furthermore, it's not necessary to go that direction for obtaining organs from deceased individuals.  We have the other systems in place that can be further extended to basically do the best we can do with relation to those who are deceased.  And so we tried it by analysis of direct and indirect in ways that would let us see the possibilities ethically speaking as well as the limitations and again came to the conclusion that we should not promote financial incentives direct or indirect at this time.  We left open the possibility of future consideration, reconsideration.

Now nonfinancial incentives can go a couple of ways.  One, you could do it in terms of eligibility for a future transplant.  If you want to be eligible for a future transplant, you need to indicate that you are a donor, join a the club as it were.  The Life-Sharers' model is a little closer perhaps to the preferred status and it's a private club within the large club.  The other possibility would be giving some priority points for future transplant to individuals who have documented their decision to donate.

The conclusion we came to here while obviously keeping open the nonfinancial incentive or community recognition, we came to a recommendation not to go forward with this type of incentive as well other than community recognition in part because in our society at this time, we believe that the conditions of unfairness and injustice are such and that related in part to the allocation of organs that they are in the words of the report "insurmountable obstacles to instituting a program of nonfinancial incentives."  And I won't go through the details of the recommendation.  We can come back and talk about any of these points later.

To stay within my time limit, let me turn to the living donors.  So `88 to 2005, you can see the shift.  You can see the increase in all donors.  You can see the increase in deceased donation, gradual and you can see the more dramatic increase in living donation.  But that's not the only important point and you can see in 2001, we actually had more acts of living donation than we had of deceased donation.

But something else interesting that's happened in the period, this is just from `95 to 2004, and that is the relationships between living donors and recipients and what I would note is other unrelated, unrelated other than the categories here, in 1995 4.7 percent.  In 2004, 21.1 percent.

Now what I would emphasize again in relation to a point that was made in the discussion earlier is actually the studies have been conducted of decision making including the motivations for the decisions among living donors, those studies focused especially in the early `70s and late `70s, Roberta Simmons and colleagues, focused on those in special kinds of relationships.  It was actually a long time before it really moved out to including more spouses.  So there were special kinds of relationships.

We don't even know now whether the same kinds of patterns of decision making persisted for individuals in those relationships and we certainly don't know it for these new relationships.  So we don't know whether to talk about altruism or some other kind of motivation.  We simply don't know.  So that's one of the things that certainly needs to be done.  You see I'm going to come to some kind of recommendation for the President's Council in a moment as well.

And we ended up also saying the following that since we don't know a lot about this area that we need to ensure voluntary informed decision making or recommend as the HHS Secretary's Advisory Committee has also that there be an independent donor advocacy team and a lot of transplant centers have those.  But and most importantly, to go back to the discussion of risks that occurred earlier, we actually don't know the risk even of living kidney donation past the short-term complications.

There will be a study coming out in a medical journal in the next few weeks that indicated in terms of followup that as a matter of fact in studies where you put them together, studies related to subsequent increasing blood pressure and hypertension you have to do them actually, you have to bring all the studies together in order to even see a statistical difference but then it does show up that even in those studies that over 30 percent of the people were lost to followup.  So there's a lot we don't know here and so we're recommending that there be registries of living donors to follow up over the long term.  But also we don't know about the psychosocial outcomes.  Again, we've had over 80,000 living donors of kidneys.  So we know a lot about short-term complications.  But we don't know a lot about the long-term implications for health and for psychosocial factors.

Now I would note that this was, the living donation which I've just mentioned and the final chapter is a brief chapter and it was not the core of our report as someone rightly noted in the previous discussion.  We were asked to look at increasing the rates of deceased organ donation.  This is an area that I think cries out for further attention and is an area that would actually build very nicely on the sort of work that's already been done in the papers that Eric and Gil have provided and the discussion we've already had.

We've mentioned in the report, we don't make it a formal recommendation, that this area is ripe now for some committee, whatever it is, to give this really serious attention and it becomes important because this is varied when you look at the various proposals for introducing some kind of market that you can actually get traction.  Our argument is that you're not going to make much difference, probably none at all.  It may even be counterproductive.  You may even crowd out altruism in the deceased donor arena.

But, yes, you can get an increase in the number of living vendors as they would then be called.  But the question is whether we should go that direction and given our reservations about living donation, you can see that had we addressed this, there probably would have been reservations.  We did not address that.  So I think the President's Council on Bioethics, there is a lot of ways that it can contribute to it.  I've mentioned two.  The kind of philosophical, ethical work that is being done does move this to a deeper level than what we even considered because we again took it at a different level in trying to address the policy questions.  That would be an important contribution.

A second one would be to do something with living donation and connect it with the problems that would arise if a move in the direction of a market.  So those are just two quick thoughts and I thank you very much for your attention.

(Applause.)

CHAIRMAN PELLEGRINO:   Dr. Hippen is our next speaker.

DR. HIPPEN:   Thank you, Dr. Pellegrino.  I'd like to thank the members of the Council for inviting me here today to speak in defense of a regulated market in organs from living vendors and I wish to begin by addressing some points made by Dr. Meilaender in his essay for the Council and although I'll register several disagreements of the ways in which Professor Meilaender has framed the questions, I endorse entirely his view that to distinctly start with the defense of a market in organs is to presume that a number of proceeding metaphysical questions have already been asked and answered.

So without getting too far afield, I'd like to address three points.  First, in his essay, Dr. Meilaender argues that the belief that the organ shortage is to be understood as a crisis to be solved is ultimately to imply in slippery slope fashion that death is a problem to be solved.

I've never met anyone in the course of my medical training nor have I come across in the literature the belief expressed by medical professionals that death is a problem to be solved.  My dialysis patients certainly do not believe that either dialysis or transplantation makes such extravagant promises.  For them the endurance of thrice weekly dialysis for three to four hours a session, the insertion of two 15-gage needles into their arm or thigh, is a painful reminder of how death is not a problem solved but merely averted on a day-to-day basis.

When things are working well, dialysis is tolerable and indeed is stoically tolerated by hundreds of thousands of people in this country every day.  But when things aren't working well, when a dialysis patient's tether to life is comprised whether by a Permacath infection, a clotted access, a mistreatment or worse, they can expect unscheduled disruptions of everyday life often of unpredictable durations.  Here antibiotics, catheters exchanges, access declots, emergency room visits for pulmonary edema, hypertensive urgency, life threatening hyperkalemia, myocardial infarction, stroke are not unusual.

But perhaps it's not news to many that life on dialysis is a fragile, vulnerable existence.  Does kidney transplantation then offer the promise of solving the problem of death?  On average, my patients with kidney transplants take six medications a day, though often their medication lists extend to 10 or 15 different pills a day.  In their first year after transplantation, they see someone like myself some 30 times in clinic assuming the transplant proceeded without complication.

Some develop side effects from the medications like hypertension, diabetes, high cholesterol, mouth ulcers, hirsutism, significant wakening, diarrhea, skin cancers, etc.  And some are a prescription refill away from a hospitalization.  But even absent these problems, transplant recipients are committed to a lifetime's worth of lab draws, doctor visits, medication adjustments and occasional setbacks.  To be sure, most all of them will tell you  they are far better off than they were, but I can assert with confidence that no one seriously mistakes this kind of a life as a solution to the problem of death which brings me to my second point.

I think Professor Meilaender is correct when he objects that to conceive of the disparity between the demand for and supply of organs as a crisis is to move ahead too quickly in the argument.  The concern I gather is that to view the organ shortage as a crisis to be averted is to insist on the medicalization of generic suffering that is an unavoidable component of all human life.  Fair enough insofar as it goes.

But those who argue for a market in organs, unlike those who advocate increasing donation only, need not insist that others view the current system or its eminent failure as a crisis.  Market proponents need only insist on the moral permissibility of a market in organs in the lack of a moral justification for a legal ban, not a broad moral endorsement of such a market.  In a free society whose hallmark is irreducible moral pluralism, this more modest view partially shifts the burden of proof to those who insist on maintaining the current legal proscription on a regulated market in organs.

One, if it's not reasonable to expect that human beings will continue to voluntarily suffer and die for moral precepts to which they ultimately do not subscribe, it follows that the predictable consequence of failing to address the shortage of organs is and will be the multiplication of needless and unwanted suffering and a few examples of this include an expansion of time on the waiting list which effectively excludes the vast majority of patients on dialysis without a living donor, recipients who are older and sicker when they come up for transplantation  as a consequence of their extended vintage on dialysis, increasing emotional pressure on any available donor to donate and the consequent strain on the altruistic features of donor motivation, an upsurge in the practice of international organ trafficking, traveling to a developing country for the purpose of purchasing an organ in which the incentives for vendors are to avoid disclosing co-morbid conditions, brokers to suppress any information which might interfere with a successful transaction and recipients not to disclose the transaction for fear of prosecution or ostracism by health care professionals  and finally, a proliferation of the chaotic pathos inherent in the desperate public solicitations of organs on the internet and elsewhere.  These are the entirely predictable consequences of shortage and so these reasons that I believe the transplant professionals are in the position to shape public policy on this issue bear a moral responsibility to offer plausible solutions to the problem.

A final point critical to Meilaender's argument is that the exchange of organs for valuable consideration somehow limits the value of an organ to  its exchange value.  Conversely so the argument goes,  when organs are gifted the value of the exchange is wholly determined by the fact that it is a gift.  The vendors may sell or exchange their organs for any number of reasons.  Such reasons are by his argument studiously rendered irrelevant if the only value attached to the exchange is its exchange value.

Consider some possible reasons why someone might sell or exchange their organs.  Someone exchanges their organ for a $25,000 donation in their name to a charity to which they are morally attached.  Someone exchanges their organ for a $50,000 deposit in their child's 529 tax sheltered college account.  Someone engages in an organ swap with another donor recipient pair so that their loved one might receive a transplant.  Someone exchanges their organ for a lifetime health care and prescription drug benefit or a deposit in a health savings account for which they may or may not have had before or someone exchanges their organ for $50,000 and purchases a sports car.

As best I understand Dr. Meilaender's categories that is organs either are a commodity or they are a gift with no more salient differences between these possibilities.  The view I endorse might permit any of these exchanges but would morally endorse rather fewer of them.  The point is that a generous interpretation would concede that organ vendors might vend for a great many reasons, some of which really do embody a species of moral valor, some rather less so and some not at all.  As the above examples show, the conceptual elegance of the term "valuable consideration" is that it has far more interpretative flexibility than exchange value which just implies cash money.

And the value of an organ can be assessed along many different axises of value.  An inexhaustive list of values of organs include the value to the recipient of the organ in terms of the extended quantity and quality of life gained, the value of the recipient's family, friends and loved ones from his improved condition and the value of the valuable consideration to the vendor whether that consideration is destined for the vendor or someone else.  So an aggressively uncharitable consideration is required to understand all of these means of valuing an organ procured in a market transaction as simply or nearly reduced to its exchange value.

Furthermore, as Renee Fox and Judith Swayze poignantly taught us in their travel log through transplantation the moral significance of a donated organ is not exhaustively understood by conceiving of donation as simply a gift.  Complex interactions of guilt, residual resentments on the part of the recipient for persistent feelings of indebtedness to the donor, family pressures on both the donor to donate and the recipient to receive the donation and justifiably or not accept the moral responsibility for the transplantation's success or failure all contribute to what Fox and Swayze termed "the tyranny of the gift" and to quote from their book, Spare Parts, "the psychological and moral burden is especially onerous because the gift the recipient has received from the donor is so extraordinary that it is inherently unreciprocal.  As a consequence, the giver, the receiver and their families may find themselves locked in a credit/debtor vise that binds them to one another in a mutually fettering way."

If by the expansion of the waiting list and waiting times for organs the availability of a living donor becomes the only plausible means of receiving a transplant, the desperation of recipients will strain the gift relationship to its breaking point.  In my view regardless of one's views of the market in organs, that state of affairs is properly understood as a crisis.

So then what is it that I'm arguing for?  In the paper submitted to the Council for their review, I argue in favor of a regulated market in organs from living vendors.  I don't discuss a market in organs from the deceased.  I don't have any in-principle objections to such a market.  Rather I think for empirical reasons it would simply be inadequate to the challenge at hand.

The United States is facing an epidemic of end stage renal disease.  By 2010, the number of patients with ESRD is expected to nearly double to 650,000 and the waiting time for deceased general organs will increase to 100,000 to 120,000, nearly double the current waiting list of 65,000.  Patients without a living donor with blood types O or B now face median waiting times that exceed their median life spans.

The average mortality rate of a patient who initiates dialysis is 60 percent.  That's 60 percent dead at five years.  The current national median waiting time for a kidney for recipients with blood type O is fives years and for recipients of blood type B the median wait time exceeds five years but we don't yet know by how much.  But 2010 the waiting times for deceased general organs will double and in short of a radical restructuring of the procurement system, this state of affairs will exclude the vast majority of recipients from ever receiving a transplant simply by attrition from death.

For those without a living donor, the list will degenerate into an equal opportunity to die waiting and at the current rate of growth the number of living and deceased donor transplants of 10 percent per year by 2010 we'll be able to offer about one in 20 patients with ESRD a transplant though the waiting time may approach nine or ten years unless a living donor can be identified and those few still alive will have endured the physiologic toll of a decades worth of dialysis rendering many simply untransplantable.

Since the recent Institute of Medicine report focused primarily on a market of organs from the deceased, let me briefly address this point.  First, the organ donor collaborative has successfully improved to procurement rates of organs from eligible deceased donors up to 70 percent or higher in a number of organ procurement organization areas.  But even if the procurement rate was 100 percent, the increased number of organs from the deceased is far outstripped by the growth in demand for organs since the best estimates of the number of eligible deceased donors by brain death criteria is about 10,500 to 13,000 annually.

Spain which sets the international benchmark for successful organ procurement strategies from deceased donors only has a procurement rate of 75 percent of eligible deceased donors after brain death.  An increase in the number of organs from so-called "controlled donors" after cardiac death has been an important component of the rate of growth in the number of organs available for transplantation.  But again, the HRSA estimate is that the number of DCDD donors available by the year 2013 will be 2,018 additional donors.  This would represent an important contribution but will not approach the coming demand and a reliance on so-called "uncontrolled donors" after cardiac death which the IOM report suggested might identify an additional 22,000 donors per year is fraught with moral and logistical difficulties and yields organs which will likely result in higher rates of complications in the post operative period.  I have an extended criticism of uncontrolled donation after cardiac death which is the in the footnote which will come later.

Among the many advantages of a regulated market in organs from living vendors in contrast with  the market in organs from the deceased are an increase in the number of organs available for transplantation on a scale that more plausibly approaches the current and future demand, a concomitant reduction perhaps even elimination of the root cause of international organ trafficking and unregulated internet solicitation.  The opportunity for truly altruistic living donors to donate largely free of the incessant moral and emotional pressures of the desperation of their designated recipient, an increase in the frequency of preemptive transplantation which confers graphs of rival benefit that exceeds transplantation after any amount of time on dialysis, the identification of a cohort of living vendors who are at the very lowest risk for long-term adverse outcomes eliminating another competing pressure on current and future living donors with comorbidities which are relative contraindications to donation, organs which on the whole are transplantable with fewer operative and immunologic complications as well as vastly improved long-term outcomes, the leisure of time to carefully undertake all forms of vendor screening,  organs from deceased donors are procured, screened and allocated under nontrivial time pressure, the opportunity and this is very important for highly sensitive patients who are immunologically ineligible for the vast majority of available living and deceased donors to be transplanted without undergoing a highly morbid procedure of desensitization.  Some 30 percent of people on the waiting list have some titer of antibodies against human antigens which excludes them from getting many kidneys even when their blood type is common.  And for the organ vendor, an opportunity to improve the lives of others through an agreed-upon exchange for consideration that the vendor deems valuable in a manner that is safe and respectful of the agent's moral agency.

As a condition of moral defensibility, I argue that a market in organs from living vendors must fulfill four sides constraints: first, the priority of safety for the vendor and the recipient; second, transparency regarding risks to the vendor and the recipient and regarding institutional outcomes for followup care; institutional integrity with regard to establishing guidelines which broadly reflect the conditions under which a given institution will and will not participate in organ vending including a mechanism of mediating institutional financial conflicts of interest; and finally operation under a rule of law providing an avenue of enforceable redress if contractual obligations are violated.

Before discussing these in detail, I want to emphasize that a regulated market in organs does not pretend to exhaust the list of obligations owed to donors, vendors and recipients just as the law does not exhaustively catalog one's moral obligations to one's self or others.  Nor does a market ignore, dissolve or rationalize away the manifest, deep moral differences between those who find cooperation with the regulated organ market acceptable and those who judge it a grave moral violation.  Just as there will always be physicians who will not cooperate with vendors under any circumstances, there will also be recipients who hold similar moral commitments.  The salient difference is that in a market these forms of cooperation need no longer take place under the conditions of desperation fostered by shortage.

A living vendor market first and foremost must be safe.  Safety has both moral value and market value.  The moral value of safety is an extension of the commitment to the medical professionals to non-maleficence.  That is to avoid causing harm to those under one's care.  Meeting this obligation entails treating donors, recipients and vendors in a manner consistent with the current state of knowledge regarding best practices and standards of care.  In accepting this responsibility, individual physicians are therefore under no moral or legal obligation to participate in a vendor exchange if it is their considered opinion that either the vendor or the recipient is medically or psychologically unsuitable.  Evidence-based guidelines regarding the pre transplant  evaluation of donors should apply equally to the evaluation of vendors ironically.

A favorable consequence of prioritizing safe practices in evaluating potential living vendors is that the standards of vendors will likely be far more stringent than those currently applied to donors.  Since valuable consideration can be anything that vendors identify as valuable to them, incentive structures can be designed so that the priority of safe practices directly intercepts with the valuable consideration exchanged.

Morally speaking, very little terms on what the valuable consideration actually is.  Rather the moral defensibility of the consideration is predicated on whether or not the exchanges satisfies the side constraints.  Example and this is just an example, imagine that the Federal Government puts up for competitive bid a contract for lifetime health insurance for donors and vendors alike awarded immediately upon donating or vending an organ.  Part of the responsibility of the insurance company that wins the bids is a commitment to provide annual physicals, routine medical screening and long-term followup in addition to standard medical coverage for non-donating and vending related health issues.

Such an arrangement would serve a number of interests.  First, it would provide donors and vendors with long-term health insurance, by any measure a valuable consideration.  Second, it provides the transplant community with a funded mechanism whereby the long-term outcomes of donors and vendors  can be carefully studied and aberrancies can be identified, analyzed and addressed.  And third, it structures the incentives for the insurance companies in a number of mutually-attractive ways.  The donor and vendor pool represents a cohort of people who at the lowest risk for future medical problems and who are therefore the least expensive to insure.

Interestingly, for those concerned about a market exploiting only the poorest among us, an incentive structured in this fashion may actually exclude from vending those in the lowest socio-economic strata since there is good evidence that membership in this strata increases the risk of developing chronic kidney disease and I include in some footnotes a handful of references to document data.

The second side constraint, transparency is an extension of the physician's obligation to truth-telling, a component of respect for the moral agency of donors, vendors and recipients and by transparency, I mean a forthright disclosure of the risks involved to donors, vendors and recipients insofar as they are known as well as the disclosure of what is pertinent but as yet is not known.  Included under the rubric of transparency is an obligation on the part of the transplant community to extend our knowledge of long-term outcomes for donors, vendors and recipients.

The third side constraint is that of institutional integrity by which I mean establishing procedural assurances whereby institutions can cooperate or not with vendors according to the dictates of their stated mission.  As a matter of policy, a health care institution might abjure any cooperation with living vendors with perhaps modest exceptions for emergencies.  Alternatively, an institution might cooperate with vendors on a limited basis and individual practitioners might be given the choice to cooperate or not with living vendors similar I might add to current arrangements with living donors.

The point is that the specific content of individual institutional policies would be less relevant than that institution's formulated policies that accurately articulate the moral commitments of the institution and that such policies may have side constraints.  Formulating such policies as an extension of the side constraint of transparency, recipient candidates are not neutral on the subject of organ vending and some will find it inconsistent with their moral commitments, but the genius of an organ market is that it permits like-minded donors, recipients and health care professionals committed to donation and opposed to organ vending to freely cooperate mutually attaching moral value to certain ways in which organs are or are not procured commensurate with their common moral commitments.

Of course, individuals and institutions constituent of these donor-only communities would benefit indirectly from an organ market by reducing the overall demand for organs.  Still recipients who choose to abstain from cooperating with organ vendors for moral reasons could do so even unto death.  Conversely, recipients who are willing to cooperate with organ vendors are also entitled to know a priori  the position of their transplant institution on the subject of organ vending since a failure to disclose this would be a grave violation of respect of the moral agency of the recipient in question.

At this point, it's useful to explain what I mean by the "right" to vend an organ.  I conceive of the right to vend as a right of forbearance which is to say a noninterference right.  The right to vend understood in this way does not imply a correlative obligation on the part of individuals or institutions to cooperate with any individual vendor.  Instances in which cooperating with a vendor would in the judgment of a transplant professional violate the side constraints of safety, the obligation is explicit.  No cooperation.

After all, the only value of a market relationship is instrumental.  The primary purpose of an organ market is not to enrich vendors or solve the problem of the uninsured or anything else except relieving the suffering of recipients without transferring that suffering or harm to donors or vendors in the process.  In this sense, a regulated market in organs represents what is best and morally nonnegotiable in the current system of organ procurement.

The final side constraint is the creation and application of the rule of law to a market in organs.  Legislative oversight of a organ market is necessary to ensure that the standards of safety are met, to ensure good faith enforcement of contracts between vendors and other entities and to protect against fraud.  Ideally, the law should serve as a side constraint on other means of assuring institutional integrity such as the accrediting powers of professional organizations with voluntary membership.

In this, I endorse an argument made by James Buchanan wherein the rule of law should have two basic functions, first a productive function which facilitates freely agreed-to arrangements between individuals and institutions and a protective function which protects the contractual and forbearance rights of vendors, donors, recipients, professionals and institutions.  The productive functions of law include provisions for a common market in which potential vendors and institutions can meet and negotiate transactional terms.  The protective functions of the law might include designing sample contracts that satisfy the side constraints of safety and transparency, offering adjudication and mediation mechanisms for resolving a range of contractual disputes and mediating conflicts of interest like financial inducements to increase vending through the subversion of safe practices.

Now I know this all sounds rather legalistic and so it is.  Ideally, the rule of law permits those with the best intentions to cooperate without interference and sharply proscribes the activity of those with the worst intentions.  But to repeat an earlier point, the rule of law in no way exhausts obligations physicians owe to donors, vendors and recipients.  However on some, hopefully very infrequent occasions, the rule of law prescribes the bare minimum of obligation.

So how would all of this work in practice?  For those expecting an endorsement of a particular set of financial incentives for organ procurement, I will disappoint you on purpose for two reasons.  First in my view the specific nature of the incentive is only morally relevant insofar as the exchange of an organ from a vendor for the incentive is commensurate with the moral side constraints I've outlined and, second, to endorse the single example of a morally-permissible valuable consideration would be to engage in the economic equivalent of price fixing with all the pitfalls which follow.  Again, the elegance of the concept of valuable consideration is that it is indexed to what individual vendors conceive of as valuable to them what you or I or someone else presumes to be valuable to them.

So as to the structure of an organ market, I think the best approach is to permit a variety of different types of valuable consideration to be exchanged subject to meeting the moral requirements of the side constraints.  The virtue of this approach is that by giving wide latitude to the specifics of valuable consideration the resulting plurality of arrangements are also the most likely to be successful.

After all, any incentive structure however mortally defensible must actually work.  That is to say it must actually substantially increase the number of available organs.  Incentives which don't work should be discarded and a simple way of doing this is to offer a list, some types of valuable consideration and prevent the vendor but to choose from among them.  Determination as to whether specific arrangements and incentives fulfill the side constraints is a judgment best made a priori with oversight from a separate entity held responsible for tracking defined outcomes  of vendor-recipient relationships.

Ultimately, I think that the list of possible vendor-recipient exchanges which are also practically feasible and which also meet the side constraints will be finite and that institutions cooperating with vendors will be able to rapidly generate a fairly standard list of options.  As to the side constraints, the most recent decree by Health and Human Services empowering UNOS and the OPGN to generate evidence-based guidelines for the evaluation and long-term followup of living donors and assume a modicum of regulatory responsibility for its implementation could easily be tailored to vendors as well.

There have been several proposals for pilot studies of financial incentives for organ procurement and here I would insert a caveat.  It's quite easy to design a pilot study of financial incentives that is certain to fail.  Any incentive regardless of whether it meets the side constraints which fails to increase the number of organs fails as an incentive as well.  The failure of a single incentive to increase the number of organs does not imply a failure of a market to increase the number of organs.

Concerns have been raised in many quarters about who organ vendors would be and specifically whether vendors would inevitably come from the poorest or otherwise most vulnerable among us and here I would like to make a few distinctions.  First, by definition, the forbearance right of vendors qua right of forbearance cannot supercede the side constraint of safety and institutional integrity.  As previously mentioned, the poorest among us are also at higher risk for the development of kidney disease as well as the risk factors for cardiovascular disease which would be accelerated in the setting of unilateral nephrectomy and this epidemiologic fact alone may be morally sufficient for to exclude the poorest among us from eligibility for organ vending.

Second, it would be clear that justification for excluding the poorest among us would not be because vendors are somehow rendered incapable of autonomous decision making by virtue of their poverty.  The justification is that cooperating with them as vendors violates the side constraints.

Third, a regulated market subject to side constraints should be sharply distinguished from the current practice of organ trafficking which is subject to no constraints whatsoever.

And finally, vulnerability is not limited to those who are impoverished.  Those concerned about the vulnerability of vendors should be equally concerned by the magnified vulnerability of living donors in the absence of a plausible solution to the shortage of organs.

So to conclude, public policy in renal transplantation is at a crossroads.  There is not serious disagreement regarding the forecasted increase in demand for organs in the next decade nor about the fact that current strategies and proposed reforms for organ procurement are vastly insufficient to meet this demand.  As the waiting lists and waiting times expand, the hopes of transplant recipients are fading. This is not a hope for eternal life, but a hope that they might be spared a life cut short too soon.

It's a hope that was dashed for the 3,500 who died on the list last year waiting for a kidney as well as all who cared about them and who cared for them.  None of this justifies policies that treat people as spare parts or any other epithet denoting organ vendors as less than the moral agents that they unmistakably are.  But taking the moral agency of organ vendors seriously entails abandoning the easy but ultimately false generalizations about the moral and psychological makeup of vendors and work-a-day dismissals of a market solutions.

These generalizations reduce vendors to characters in a passion play about exploitation and greed rather than understanding them as human beings capable of fashioning and acting on their own moral commitments, hopes and aspirations.  Mine is not an argument that the ends justify the means.  The argument is that the means themselves as I have argued for them here do not warrant legal prohibition.  Thanks you.

(Applause.)

CHAIRMAN PELLEGRINO:   Professor Schaub, one of our Council members, will now open the discussion on both papers.  Thank you.

PROFESSOR SCHAUB:   It's been a long day.  We've gone over the data, the philosophy and the ethics of organ transplantation and procurement and now it's time to look at policy proposals.  At the end of the day, we must face the question "What is to be done?"  To help us out, we have two well-developed and thoughtfully articulated proposals on the table, one which focused on deceased donation, the other on living donation.  I want to thank both presenters for their appearance here and even more for their work that they've done on this issue.

The first report from Dr. Childress and his committee at the Institute of Medicine stays largely within the current framework.  As he says, it might be described as a conservative contribution.  It specifies a number of ways by which the rate of deceased donation might be increased without departing at least for the near term from the ethical norms and assumptions of the existing system.

By contrast, Dr. Hippen along with an apparently growing number of others calls for a radical departure from previous practice.  He calls for a shift from deceased donors to living vendors.  In his article and here today, he's argued for the morality of a regulated market in organs.

I have a couple of questions for each of you.  Dr. Childress, I very much appreciate the thorough attempt your group has made to improve the procurement system and increase the rate of deceased donation, but even if all that you recommend is done, how much difference will it make?

Dr. Hippen seems to begin from the assumption that any system dependent on donation is simply inadequate.  Do you disagree or if you agree that the donation numbers will inevitably fall short of demand would you also move eventually toward quality firm market solution?

On page 201 of the report, the committee recommends against financial incentives in the case of deceased donors, and the report reiterates that opposition even more strongly opposition to the sale of organs in the chapter of living donation, but that negative judgment does not seem to be made on principle.  The report says "the use of financial incentives to increase the supply of transplantable organs from deceased individuals should not be promoted at this time."  Why the qualifier "at this time"?

I was particularly interested in this locution which turned up at other key moments in the report.  For instance, and you went over this today, the report recommends that "at this time, the current system of voluntary express consent should not be replaced with either a system of mandated choice where individuals must indicate yes or no for organ donation or a system of presumed consent where individuals are presumed to have said yes unless they actively say no."

However, the committee clearly, your committee clearly, would like to move toward a system of presumed consent in the future and to that end they recommend a campaign to change public opinion.  I'm sure you're right to focus on public sentiment for as Abraham Lincoln said, "Without it, nothing can succeed."  But I'm not altogether certain about the goodness of the reform that you propose.

The report states that the education of public opinion mostly involves relieving people of their fears and misconceptions about organ donation and transplantation and then further presenting donation itself as a decision to be made from a combination of self interest and social responsibility.  Basically, it's in one's own long-term self interest to be willing to donate parts of oneself or at least parts of one's former self to one's fellow citizens.

How would you respond to the arguments laid out by Leon Kass and Gil Meilaender that there may be more at work in resistance to organ donation than fears and misconceptions?  That there may be instead some deep-seeded wisdom about the body and its meaning.

Finally, if people's lingering hesitancy or reluctancy did disappear as a result of the attitude-changing efforts that you recommend, why would a presumed consent policy be necessary?  At that point, wouldn't a policy of expressed consent be working just fine and producing high donation rates?  Might there not be reasons to prefer expressed consent, reasons that go considerably beyond the question of organ donation?

We modern folks out of the best of motives might be able to forget about or overcome our natural antipathy to the violation of corpses but I would hate for Americans in particular to forfeit their stubborn insistence on real consent.  Certain elements of national character may serve as constraints upon our policy options.  I happen mostly to admire those elements of the national character, but even if I didn't, I'm not certain I would want to challenge them.

My appeal to national character or the general spirit of the nation as grounds on which to reject a system of presumed consent and even more a system of organ conscription might suggests that Dr. Hippen's route is the way to go.  The commercial spirit is surely a big part of the American spirit, but respecting national character does not require us to give the commercial spirit completely free reign particularly if the case can be made that both reason and the commercial tradition itself disallows certain types of markets.

Dr. Hippen says in his paper that "an organ vendor in a regulated market would be treated as an end in himself inasmuch as his safety and contractual rights would be protected by the rule of law."  Are those the only items, safety and contractual rights, that must be protected in order for the demands of human dignity to be met?  Are there any regulated markets that you would find morally impermissible, say legalized state supervised prostitution?  In other words, how far does the right to vend go?  Is there anything about the human body that makes gift rather than sale the proper course to follow?

CHAIRMAN PELLEGRINO:  Thank you very much.  Do we have a response from the presenters.

DR. CHILDRESS:   Yes.  Thank you very much. I'll join Ed in thanking you for the presentation and for the questions.  I think they are very important ones.  Let me just address a few of them.

First of all, we approached this from the standpoint of trying to formulate ethically acceptable and even in places ideal public policy in a particular society and culture at this time.  We felt on the basis of the evidence that we had seen that indeed a lot of progress was being made in several different areas including the kinds of systems that have generated in a number of institutions up to 70, 75 percent of consent rates from potential donors, donors and/or their families for donation.  That this is something that can really help us get a substantially large number, larger number, of those who within our current pool have been declared dead by neurological standards.

So we think that considerably more progress can be made there as well as putting more emphasis on education and yes, we did talk about some of the myths and misconceptions and it's not clear, and this is a matter for the study, it's not clear how many of the conceptions that work that people have and I won't characterize them here as misconceptions would actually be close to the sorts of concerns that both Gil and Leon and then also in Eric's paper have identified.  I think that merits closer attention.

Actually in the context of discussions I have with individuals inside and outside organ transplantation and members of the public, those concerns may be below the surface.  They rarely get raised.  The other kinds of concerns get raised and I think this is one of the important things about the kind of analysis that the President's Council may be able to undertake and that is to dig more deeply into some of those fundamental, philosophical, and here I'm going to use a term, mythological not in a pejorative sense because they in part have to do with some of the fundamental myths that we have that structurally we think they could well be at work and I think we might well look more closely at that.

Now in add to the current policies and practices that seem to be making considerable progress, again our radical proposal was to move toward, and you wrote this and addressed this in your comments, move toward getting more donations from those who are declared dead by circulatory standards.  That is a radical departure from current practice.  It is a very promising one and I think it's actually one the public would be more inclined to accept than professionals.

Professionals have grown very comfortable with the notion of brain death.  It's a fairly orderly way to perceive, fairly set and so forth.  It's not as messy as dealing with uncontrolled donation starting outside the hospital setting.  So it may well be that this is one where after all people are quite familiar with people dying according to circulatory standards.  That's the way most of us are declared dead.

Now that's not to say that there are issues and there are several that would have to be addressed to go in this direction and we identified some of those, but I think at least pilot studies could establish whether indeed this is the way to go. At this time then is our indication that we have some confidence that what is already in place and being further developed and then with this expansion of the donor pool could help to alleviate but probably not eliminate the shortage.

Then the question really is whether we want to go in the direction of living market and I have serious reservations about that, ethical reservations.  Some of them do relate to concerns about comodification and what happens when we move this direction and start thinking about ourselves as potential sources of organs that can be bought and sold and I'm concerned and I've raised this with Ben whose work I very much appreciate and Sally Satel whose work I also appreciate that the Kaiser regulatory mechanisms that are put into place even if we don't think they are intrinsically wrong to go in the direction of a market haven't yet convinced me that there aren't still serious ethical problems relating to if not coercion at least exploitation and so I would need to be, receive a lot more information about and have a much more serious and sustained discussion before I would be convinced that we've been able and what's being proposed to avoid those sorts of things.

So I guess those would be my main comments.  One last point which actually has to do with your more negative comments about presumed consent.  I think that the discussion of presumed consent among the Council got off to a bad start by virtue of Bob Beech's discussion.  Bob is talking about implementing that sort of policy in our society  as it stands where indeed it would be problematic for precisely the reasons he indicates.

But a society could move in directions that would say on the basis of reciprocity which we've taken here to be an important consideration in which we're all members of a system and so forth that society could well move in that direction and we have all sorts of default mechanisms in which we will accept silence or tacit consent or approval as a basis for operation, but it would have to be very careful developed.  So in suggesting at this time for a number of these possibilities, I'm not suggesting that everyone on the committee would indeed say if we don't obtain enough organs than we ought to move in these following directions.  But rather it would be a matter for reconsideration and that would be true for presumed consent.  It would be true for mandated choice.  And it would be true for financial incentives as well.

Thank you and I hope that partially addressed the important points you raised.

CHAIRMAN PELLEGRINO:   Dr. Hippen.

DR. HIPPEN:   Thank you.  I guess I'll first take the question of whether what I endorse is free reign for an unrestrained market and I would say it's certainly not.  I think that the side constraints that I outlined are as my mentor, Tristam Engelhardt, might say thick in the sense that they sharply curtail a number of different vendor relationships that would be out of bounds.

I also think I should reiterate that the side constraints that I argue for are the conditions for moral permissibility but they do not exhaust our moral obligations to donors, vendors and recipients.  I can talk a little bit more about that in the subsequent discussion, but I think one also has to be careful of the hazard of excluding by omission.  The obligations to vendors in this case are perhaps best not cataloged but identified and may well arise relative to whatever arrangements are being made.  So in that sense, no, the side constraints do not exhaust what physicians would owe vendors in such a system.

I also want to talk a little bit about analogous systems like prostitution and here again, I think a certain conceptual care needs to be taken to avoid equivocating prostitution with vending.  Now some will actually equivocate that.  I would sharply disagree, but on the issue of prostitution as a regulated market, we do in fact have legalized prostitution in at least one state in the Union.  But the permissibility and regulation under law in no way, I think, entails its moral endorsement and I want to cling to that distinction between what the law permits and what morality requires.

And along those lines, you quoted me to the effect of saying that I believe that we should treat organ vendors as an end in themselves and that is correct.  I believe that is the beginning of how physicians and the rest of us live up to the obligations we have to one another which is to treat each other as observed as an end in oneself.  But that is the beginning, certainly not the sum total of what we owe to each other.

CHAIRMAN PELLEGRINO:  Leon.

DR. KASS:   Thank you.  Thanks to both of you for really an excellent presentation and very stimulating things.  Let me make a couple of comments on terms and then move to a question for each of you if I might.

We had some discussion this morning about crisis.  I would simply at least personally flag for similar attention the notion of epidemic that's been tossed around here a few times.  Unless I'm wrong, there's still a element of communicability with respect to epidemic.  Things could be on a very large scale and very worrisome, but you produce a different kind of social response if you're thinking of a plague than if you're thinking of a massive set of diseases.

Similarly, on the business of altruism, I don't think I've used the term.  I don't think Gil's paper uses it partly because it really does deal with motives and I think Gil and I are not so much interested in the complicated motives why people might give, but more interested in the fact that as between a gift and a sale we're on the side of giving.  And that goes also to your comments about there are multiple kinds of values subjectively held by the people who might nevertheless engage in a sale.  I think psychological things are true and I think very important, but they don't finely cut the ice on the final question.

And lastly, on the subject of terminology, I know why vendor is a replacement for donor because we begin with the language of donor, but I find it already an interesting slip when we begin to refer to people as "living vendors" as if that is somehow the way they come to regard themselves at least for these purposes.  Those linguistic terms have moral freight and we should be attentive to them.

Two questions.  For Jim, I think you partly answered this in your response to Diana, but if you were moving in the direction of presumed consent as you've nicely distinguished it from salvage, could you state what the sort of political, social, anthropological theory is that would lead you to support this other than the utilitarian argument it's going to get us more organs because the burden of proof is on people to sort of opt out?  What the ground of saying the organs belong to the community unless you object and I'd like to hear you say something on that.

And for you, Dr. Hippen, it's your libertarianism that I want to press.  The notion that moral permissibility does not require, does not translate into approval.  That's correct.  But if you somehow went from a system which said we outlaw prostitution to a system which says it's legal but we don't approve of it or if you go from saying we're now going to allow people to sell themselves into bondage, absolutely voluntary, we'll set up a nice hospital committee to check them out to make sure we know what they're doing because they want to pay for their children's education, that would be a transformation of the societal view on what it means to own another human being even if with consent.

So when you say that the burden of proof lies with those who would stand in the way of the rights of individuals to vend if they so wished, in other words to get out of the way, you're not looking for approval, you just want these restraints relaxed, (a) I think it's tantamount to a kind of approval if you go from a system which says that something is outlawed to saying it's now tolerable, but (b) I don't see why my side has the burden of proof since I think what's being protected in the proscription of buying and selling is something deep and you have to, I think, show why that should be overturned and to say that lives will be saved isn't a sufficient reason.  That would be a challenge to you.

DR. CHILDRESS:   Thanks Leon as always.  A couple of comments on terms and I was here this morning for the discussion and I don't recall any discussion this afternoon how the term altruism appeared, but I would at least note that in Eric's paper, it seems to me that a lot of it is used in a way that captures a lot of that.  So I was probably running too many things together at that point when I was talking about it and thinking I very much agree that we can have all sorts of motives within a donation system and that keeping those distinguished is very important.  You can just have altruism operative in the kind of system that Ben has described.

Second, living vendors, I was one of those a number of years ago who started pushing the term "vendor" in part because it seemed to me to be for those who were proposing some kind of market mechanism that in effect they were mixing worlds by talking about basically those who sell as donors, but donation does have as you rightly said and it seems to me it's with your model that donation does have some things to characterize it and then to talk about those who are selling their organs as donors, paid donors, is already to mix worlds.  So by pushing vendor, it was trying to say then you have to argue for this in terms of the nature of the transaction.

In terms of presumed consent, and I didn't I realize address part of Professor Schaub's comment as well, I guess I would suggest and I'll try to do both in response to Leon's comment and Professor Schaub's why I would say the organs belong to the community unless you object.  I guess the way I would think about this is you have transferred the organs to the community unless you object.  A simple example I use with my student I think actually makes the point very well that we have a variety of ways we accept certain possibilities by doing so tacitly.  I mean love is used to get the notion of tacit consent that may be problematic, but it's a way to start thinking about this.

I tell my students I'm going to cancel the final exam unless you object.  Their silence I think can be appropriately counted as consent, but there has to be understanding, there has to be voluntariness, etc. before we find it.  Now it seems to me that that would be an idealized model of presumed consent, but nevertheless and presumed consent, I think we stayed with that term, but in many ways it's an inappropriate term.

It would be better just to talk about it as  tacit consent or silent consent and that means in response to your earlier comment this is real concept.  What Bob Beech was talking about was hypothetical consent and what people would do if they were asked and they know that many would not and so forth.  This is talking about it in the context of social practices where people understand and they know that they have express or silent and a variety of other way of responding.  That may not be realistic and you're right perhaps that if it were possible it might be an unnecessary parallel to the point made about mandated choice.

Then the last observation I would make in distinguishing routine salvaging and routine removal and the like from the model of presumed or tacit consent, I focused on the ownership side, but there is another way.  That is who actually owns the organs and thus who is involved in the transfer.  But there is another part that's important and that really is a system of silent consent or presumed consent.  Then there's a heavy educational burden on the part of the state of society, not so if there is routine salvage or conscription.  That may not even be part of it.  There's a possibility of opting out in both, but it really is a presumed consent that is going to make sure it's understanding and voluntary consent even if expressed silently.

Then you need probably need more even than you have in the expressed consent model because at least there you take the action of expressing it as better evidence of the person's choice than the silence and the silence is worrisome in part.  That's why most of the systems that have this and it's not clear whether they have routine removal or presumed consent tend to check with the family just to make sure.

DR. HIPPEN:   Thank you.  That's a beautiful question actually and I have two points in response.  First, I think again it's important to be careful before making analogies between a regulated market in organs from vendors and other kinds of markets because any other sort of markets in things like prostitution or what have you have lots of connotations and if we're going to make such comparisons we need to follow through on the connotations.

On the strictly legal versus permissible or permission versus endorsement point, I would suggest that the fact that in Nevada prostitution is legal has not widely, broadly increased moral support for prostitution.  So the level on which introduction a regulated market in living vendors would damage something deep and metaphysical may be the case, but I really don't know how to adjudicate that claim because I just don't know what the terms of the debate are.  That's neither here nor there.  We can perhaps that discussion at greater length.

But I would want to emphasize though a market in organs from vendors is so that people don't have to unnecessarily suffer and die, but there are other reasons as well because this all occurs within a larger social context.  Last year, the Federal Government alone not counting private insurance spent $17 billion on the care of patients with end stage kidney disease.  But 2010 that's going to be in Federal dollars only $28 billion and to spark my latent libertarianism, $28 billion of tax money from people who earn it and pay the Federal Government this money.  It's going for the care of these people and I think it should.  I feel that these patients are a part of my moral community, so conflict of interest.

But the other issue there is that as the waiting time increases there will be damage to altruism.  I do care about altruism.  I think it's a privilege of what I do.  It's the opportunity to interact with living donors.  These are a remarkable group of people and some of them remind me of Kierkegaard's Fear and Trembling when he talks about  the knight of faith.

The knight of faith is the guy who goes and hears the sermon on Sunday about Abraham and Isaac and Isaac being taken up in the mountain and God commanding him to be killed and Kierkegaard marvels at that fact that here's this guy.  He's drinking his Starbucks coffee and he's eating his bagel and the moral import of what God has commanded Abraham to do he just kind of lives with it.

And that's remarkable to me in interacting with living donors is how unremarkable it is for so many of them.  "Well, of course, I would donate my kidney.  Of course, I would.  It's my mother.  It's my sister.  Of course, I would."  And so amidst everything that's been written about living donors and lionizing them and rightly so, they really sort of take it stride.  But I think that is being damaged.  I think that is being strained to its limits by this problem and for that reason I do think it's a problem and I do think it is a crisis because that is a deep moral reflex that is being challenged and stretched to its limit.

And the other issue here is that with the increase in demand for organs and with the knowledge we are no longer in Eden when it comes to transplantation with the knowledge that this is an opportunity for people to live longer and better lives a failure to address this in an plausible way will increase the manifestly immoral practice of organ trafficking, a practice which is unsafe for vendors, unsafe for recipients, something I have no difficulty categorizing as exploitative.  All of these are consequences of a failure to address this issue in the most plausible way.  I do not believe any of the suggestions made by the IOM address this in a plausible way and I feel a moral responsibility based on knowing this to advocate something that I think can be done in a morally permissible way that will address the problem.

And the last thing I want to just say and then I'll turn it back over is you know to characterize organ vendors as selling themselves is I think phenomenalogically inaccurate.  Vendors aren't selling themselves.  They are selling a nonessential organ and that is different.  To sell one's self is to in a sense abdicate one's own moral responsibility. That is manifestly not the case in the sort of thing that I'm talking about and by the way, they are not selling their kidney to make soap.  They are selling their kidney to help somebody else, possibly also themselves and I stipulate that some people who do this may do it for reasons that have no moral value whatsoever, may even be immoral.  But I believe this is the only way we can truly and plausibly address this problem [which will have] multiple consequences if we don't [solve it], not just saving lives.

CHAIRMAN PELLEGRINO:   I have three requests for comment, Schneider, Meilaender and Gomez-Lobo.  We have exceeded our time but we will extend it in the following way.  I will ask them to present their questions.  I will ask the respondents to hold off until the questions have come through and then I'll give you an opportunity to pick one or two of them lest we go on for too long.  So we'll begin with Professor Schneider.

PROFESSOR SCHNEIDER:   With extraordinary self-discipline, I will stop myself from commenting on the presumed consent question which lawyers have a lot to say about and instead say that what I've missed in a lot of the conversation is the point I made earlier in the day that very often when we have people from whom we want something but do not want to actually pay them for it and when those people are giving up something in order to give us what we want we pay them for their trouble and the expenses and their genuine difficulties that they have and not for the item that we're getting.

So with foster parents, we pay foster parents because it's a lot of expressed cost to be a foster parent.  We don't necessarily pay them an extra profit on top of that and with many other kinds of goods as well.

CHAIRMAN PELLEGRINO:  Thank you.

PROFESSOR MEILAENDER:   I'll just for Jim Childress mainly I would thank you for the directions you offered.  I thought that was helpful.  I had a couple questions I wanted to ask you.  I'll just ask one about the IOM report that I'd be interested in hearing what you had to say with respect to the category in which you suggest if we push on it, these uncontrolled cardiac determinations.

So I'm at work.  My wife keels over at the library say.  They call 911.  They come.  They pick her up.  They try to resuscitate her on the way, but decide that it just is impossible.  So they start injecting her with stuff to preserve the organs and it takes them an hour and a half to track me down wherever I am and I finally get over the hospital.  Don't you think I ought to just kind of sit at her bedside for awhile without answering a bunch of questions about whether they should continue with this procedure to preserve her organs and whether it's okay to donate them and so forth? 

I understand that here is an unexploited possibility and yet it just seems that it goes the wrong direction contrary to what — I mean we've worried about inhumanity in dying in so many other ways and now in order to get these organs you recommend that and I'd just be interested in hearing how you would respond to that.

Dr. Hippen, I don't even know if I can make this question entirely clear, but you're sort of interested in the tyranny of the gift which you think is the Fox-Swayze notion and you put that forward as it were as support for your own move in the market direction though Fox and Swayze certainly didn't think  of it.  That was just one of the complications of the gift system as far as they were concerned.

But could you just think about this a little bit that you're right that the tyranny of the gift is experienced in certain relationships that are inherently unreciprocal, whereas it were one can almost never get back to an equal position with somebody who gave you that gift of life and I suspect it's true that one could overcome the tyranny of the gift by commodifying the relationship in a way which would as it were look for a way to get back to equality.

There's a real tyranny of the gift in the parent-child relationship.  That's why children so often resent their parents.  You can never get back to an equal starting point with your parents.  We could commodify that relationship.  That would be a way of overcoming that the sort of natural resentment that that gift of life builds in require children to provide over time certain kind of reimbursement or something that attempted to bring them back to equality.  That would seem to be destructive of something fundamentally human in a way.

So, yes, commodifying can overcome the tyranny of the gift phenomenon but it's not clear we always want to do it.  Now that doesn't settle whether we want to do it in the organ question or not, but it takes a little of the sting out of it it seems to me and I would just like to hear your comment on it.

CHAIRMAN PELLEGRINO:  Dr. Gómez-Lobo.

DR. GÓMEZ-LOBO:    This is something of an information question for Dr. Hippen.  If we move to a regulated market of organs for transplantation and if we consider that we're in a global situation, how would it work in terms of the purchase at a very low price of certain organs in certain countries?  That's exactly where I'm very scared about the exploitation question.  Thank you.

CHAIRMAN PELLEGRINO:   Dr. Childress.  Dr. Hippen.

DR. CHILDRESS:   Let me respond quickly of three points.  First of all, in relation to Carl Schneider's comment, there has been a clear move toward providing compensation for expenses, etc., for living donors.  Now some talk of this is removal of disincentives to donation and it can be viewed that way.  Others talk about it in terms of expression of gratitude to those who are donating.  Both in effect are important and that would be separate from and not move as far as actually providing financial incentives to donate.

Second, Gil's example, the way he framed the question I thought was very interesting relative to his wife and he asked me whether I thought he ought to go by the bedside and just be there.  And that seems to me to depend actually on your wife's prior wishes and if you don't know those, what you think would be appropriate in that context.  So what I would say is that you ought to have the right to make that choice in those circumstances and that all starting the procedures before do is in effect preserve the opportunity for you to make that choice.  Now if she has a signed donor card and is part of a registry if this were to be widely adopted, then that would kick in and obviously be determinative and there are many different ways to grieve and to mourn and this removal of an organ does not eliminate all those but obviously the time factor is one that they were focusing on and it's an important one.

And then if I might even though it was not addressed to me, I would like to say a word about the global because I think that those who are offering the regulated market don't pay enough attention to that and second, I've heard this from for example a pediatric surgeon in Pakistan who did a Ph.D. in religious studies and has studied living donation is her worry about what despite the view that what is legal is not moral as a matter of fact is symbolically very significant and despite the criticism of the U.S. and the world adopting a market would have profound ramifications for the world and would set a kind of model that might be even more problematic in other settings.

So I'm sorry to jump in on that one, but it seems to be me a big issue that we've not talked about today.

DR. HIPPEN: Right.  So let me start with Dr. Meilaender's point.  To go back to the example I gave by Fox and Swayze, the tyranny in gift, the purposes and certainly not, I should clarify this so that I do not get in trouble, to suggest that all donor-recipient relationship are subject to the tyranny in the gift.  My suggestion was merely that to understand the relationship between donor and recipient as a gift relationship is to miss the moral ambiguities that come out in relationships between individuals and that kind of plurality of experience is what makes humans rather more interesting than molecules.

So the tyranny of the gift certainly doesn't exhaust — So the idea is that the fact that an organ from a donor is a gift does not exhaust or completely explain the moral relationship between donor and recipient.  It doesn't imply that it's always a tyranny and hopefully is mostly not a tyranny.  But if the choice is between death or that person, I would suggest that it may well become a tyranny and I do think that that's a real problem.

I want to address the issue of reimbursing parents and here I'm going to be shameless for a moment because one of my parents is in the audience and I would like to trade a little bit on the term that I used "valuable consideration."  Again, the virtue of valuable consideration rather than exchange value for repaying a debt, in this case a moral debt, a familial debt, would be grotesque if it were simply a cash payment.  It would be something that none of us really would recognize as in any way a filial obligation.  I'd like to think that what I'm doing here is in a sense a reimbursement although that's a really crude way of putting it.  But it is in a sense fulfilling a filial obligation.

Likewise, in a market and you know I think part of the problem is and I should have paid a little more attention to Dr. Kass's linguistic hygiene here, market does imply cash money, but it need not.  It never has.  Markets imply a protected area of exchange.  That exchange could be a swap as is done in recipient swaps which Dr. Delmonico was instrumental in creating in this country and that's a remarkable relationship.  I would hate to think that — I mean I do attach the label "market relationship" to that but again, I really don't have the baggage that I think perhaps others do and maybe it's just because I am in fact a libertarian and so I perhaps have disabused myself of that.

To Dr. Gomez-Lobo's question, how would this work internationally, I think that's a critically important question and I think Jim's point about the United States being in some sense making things permissible by going forward with it is one that has to be handled with a little bit of care.  And here I would sort of point out the work of a fellow by the name of Vivekanand Jha, who is a remarkable fellow, a nephrologist, in India and he and his colleague, K. S. Chugh, have documented in some detail some of the horrors of organ trafficking in India and one of the things that Dr. Jah observed is that, a couple of things really.

One is that the underground market in organs has removed the impetus for the state to create a deceased donor program in India and the deceased donation is essentially at least when I last read Dr. Jah's stuff was not up and running.  Secondly, it is not unusual even among family members in some of these countries to exchange money.  It's not understood that one is paying for an organ.  It is a consideration in the broader sense of the word "being considerate."

But let me get back.  I'm sorry.  The issue as to international protections and globalization is one that needs to be addressed in two ways.  One is the way in which this debate got framed 20 years ago in testimony before the Senate of the National Organ Transplant Act was that there was a physician named H. Barry Jacobs who told a Senate subcommittee that he intended to start a business whereby he would import people from developing countries, harvest their organs and ship them back after paying them a pittance and that subsequently relegated all arguments about organ markets to a reductio ad absurdum like that and the struggle has been to crawl out of that morass.

In my view any such arrangement would violate the side constraints because there would simply be no — And not just the side constraints but moral obligations to others that physicians would have  to vendors and I can dilate on that if you want, but we're running out of time.

I do think that a regulated market in organs can only take place within a political system and political and economic system which is sufficiently developed to generate a rule of law that is plausibly followed although there is only one country in the world, Iran, where buying a kidney is legal and incidentally it's illegal to engage in international organ trafficking in Iran.  What is conspicuous about countries in which organ trafficking takes place regularly both within borders and between borders is that that law is not enforced.  It's the joke and the practitioners will tell you that it's a joke and no regulated market in anything could take place in which the rule of the law is a mockery.  So that's my stipulation.

CHAIRMAN PELLEGRINO:  Thank you very much to both speakers.  I thank all of the members of the Council that (microphone turned off.) And tomorrow will be at 8:30 a.m.  Yes, I have my days confused.  Thank you.  It's that birthday syndrome. 

(Whereupon, at 5:36 p.m, the above-entitled matter concluded.)