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Meeting Transcript
June 22, 2006


Edmund Pellegrino, M.D., Chairman
Georgetown University

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

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

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

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

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

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

Peter A. Lawler, Ph.D.
Berry College

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

Gilbert C. Meilaender, Ph.D.
Valparaiso University

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

Diana J. Schaub, Ph.D.
Loyola College

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



CHAIRMAN PELLEGRINO:  Good morning, this is one to signal for those who are finishing their coffee that the time has come to begin the meeting.  We like to begin on time in deference to our speakers, so they may address you fully.  Good morning, if other members of the Council will come in, we have a few more to go.

Good morning.  Thank you, Alfonso, we're waiting for you.  Good morning, welcome to the 25th meeting of the President's Council on Bioethics.  My first official task which is required each meeting is to note the presence of Dan Davis, Dr. Dan Davis, the Executive Director of the Council.  He's everybody's boss, including mine and he is the official government representative and, therefore, that gives the meeting its official status. 

I want to welcome also a new council member, Dr. Carl Schneider, Professor Schneider, who is Chauncey Stillman Professor for Ethics, Morality and the Practice of Law at the University of Michigan.  In keeping with our custom, we do not go into long introductions because the accomplishments of all those around the table and the speakers far exceed any time we might have available to us in one and a half days.  So I hope they'll forgive me for this modesty and it's no attempt to downgrade their accomplishments, I assure you. 

I also want to introduce two members of our research staff who have just joined the council, Sam Crowe, who is a policy analyst and Alan Rubenstein, who is a research analyst.  Would those gentlemen just stand so members of the Council — oh, they're coming in.  They're coming in together.  It's not the Marx Brothers.  They don't have enough hair. 

I would like also to indicate to you that the Council has seven interns for the summer who work with various members of the research staff, and perhaps they will be kind enough just to stand briefly so we can see you and thank you very, very much.  These young interns come from various universities around the country and we're delighted to have them.  We're also pleased to have with us a medical student from Georgetown, Paul Hutchison, who has spent a few hours with me in tutorial but I assure you he's still in good health.  Paul, thank you very much. 


We have a very full agenda and we don't want to cut into the speakers in any way.  So that I think we'll jump right into the middle of the play.  Our first speaker is Dr. Laura Siminoff, who is Professor of Bioethics, Oncology and Family Medicine at Case Western Reserve University.  Dr. Siminoff.

DR. SIMINOFF:  Okay, I use a Macintosh computer so let's see if I can figure this — oh, somebody will figure it out for me.  So while they're figuring that out for me, what I wanted to do today,  what I was asked to do, was to summarize the issues in organ donation.  And essentially what I want to do is summarize what we really know, what we empirically know and what you need to know, I think, about how this process unfolds and what are important in terms of consent and decision-making so that you can consider what I think is a very important issue. 

So I was told to do that with not too many slides, and I was told to do that with not too many numbers.  So I hope that I can succeed.  I want to assure you that everything I talk about actually is backed up with numbers.  So I'm going to talk about the — about three factors that really impinge on what people decide to do about organ donation and then the other thing I would like to do just really briefly, if I have time and I think I'll have time, is to talk a little bit about minorities and organ donation, because it's a really critical problem in this country and I think it deserves some very special attention from you.

And the other thing I want to talk about very, very quickly is policy issues that we've sort of tried in this country and just give you a little idea about how the general public feels about those policies.  So just to give you an overview, as you all probably know, most Americans, if you ask them in a public opinion poll, you know, "What do you feel about organ donation, are you positive, are you negative, are you for it," at least 85 percent will say that they personally are willing to donate organs. 

Now, unfortunately, the numbers of  people who actually sign donor cards is much smaller, around 40 percent, if that.  And what we do know is that most people who become donors are brain dead deceased patients, and no more than 50 percent of those eligible to do so actually become donors.  So you can see at each step of the way, we lose people.  So the other thing we know is that certain segments of the population are less enthusiastic about donation.  African Americans and other minorities report that they're less positive about organ donation than the majority white community, but I want to emphasize even though they are not as enthusiastic, still the majority of African Americans, Hispanics and Asians report that they would donate their organs.

So the component to obtaining consent to organ donation are the following.  People have prior attitudes, knowledge and behaviors about donation.  There are issues around what happens between hospitals and organ procurement organizations, that's the initials OPO and I'll always be saying OPO so you'll know what that means.  And that's an issue because we have to recognize donor eligible patients in order to actually consent somebody to donate.

And then the other big issue is what happens during the request process.  So the first component that we need to look at are prior attitudes, knowledge and behaviors.  Remember, people have two different levels of thinking about this.  It's ahead of time, what would I do, as an individual?  Should I sign a donor card, shall I mark it off on my driver's license, so in that respect I can signify formally my wishes.  And the other issue is, should I tell somebody what my wishes are?  Should I tell my husband, my wife, my children what I want to do?  And most people have feelings about this. 

We know from doing many, many surveys that when you talk to the American public about organ donation, they don't say, "What is that."  Most people know what it is, 95 — at least 95 percent have heard of it and most people have given it at least a little bit of thought.  So there are a number of sociodemographic factors that are associated with donation attitudes.  As I mentioned, minorities actually donate at half the rates of whites.  Women, who act as surrogate decision makers and remember, even though we may designate ourselves as a donor on a driver's license, most of the time it's our family surrogates, our families who are making decisions about whether or not we will actually donate.  So that women who act as surrogate decision makers for patients who are brain dead in hospitals, donate more frequently than men when they're asked.  The families of younger patients donate at higher rates than the families of older patients.

So we know that consent for pediatric donors is considerably higher than that for adult donors and as the age of the potential donor rises, the consent rate falls.  And individuals who discuss donation with their families are more likely to become donors.  So looking at these factors, what does the public really know about organ donation?  The interesting thing is that because most people are going to be brain dead when they donate, one of the critical factors has been, well, what do people understand about brain death.  And one of the things that we found out in doing a variety of surveys is that less than half of the general public understands that patients are on respirators when the organs are removed, therefore, most of the public does not understand the process of organ donation.  Most people think they take the patient off of support when they obtain organs and we know from research with families who actually donated that this is also the case.  Not just the general public, families who actually donated also have these misconceptions.

Over a quarter of respondents believe that brain dead people can hear, for example.  And about half —and I think that reflects the fact that about half of the general public believes that people who are brain dead are not quite dead.  So when we talk to people what they say is, "Well, they're not really alive the way I'm alive right now but they're really not quite dead, they're somewhere in the middle."  And many Americans are concerned that organ donation results in the mutilation of the body.  And this is a particularly interesting and significant belief because we are the only developed country in the western world that currently practices open casket funerals by a majority of the public so this is clearly a real concern for people.

Over a quarter of Americans believe that if doctors know they're willing to donate organs, they wouldn't do as much to save their lives.  Three-quarters of Americans believe that rich and famous people are more likely to obtain a transplant, and most Americans believe, though, that patients will be correctly diagnosed as dead when the time comes.  So there's a certain amount of mistrust.  There's a bit of mistrust about, if I actually designate myself on my driver's license as a donor, will they just look at me and say, "Oh, they're a donor, let them die, we'll take their organs." 

And minority communities in particular are very mistrustful of this issue.  And the other thing is that there's issues around a belief in the equity of the system, so that three-quarters of Americans, including when we do this with health care providers, believe that if you're rich or if you're famous, you really are more likely to be transplanted than you or I.

Now, in terms of people's prior behaviors about organ donation, as I mentioned, we know that about 40 percent of Americans have signed a donor card or signify that they're donors on their driver's license.  And about half of Americans have actually their families that they want to donate and again, these particular behaviors are very important.  They're very important because when people know that somebody is a donor, wants to be a donor, they're far more likely to donate.  In fact, we've passed in this country a number across, I think about two-thirds of the states, laws called first person consent in which those signifiers on your drivers' licenses are binding.  In other words, you don't have to ask that family any more whether or not they would be willing to donate.

And I think this is actually a good thing because one of the things that — one of the reasons that we passed this legislation is that people had a misperception that families countermanded patients'  wishes and this is actually an example of what had been a successful policy being passed for the wrong reason.  In point of fact, very few families ever do that, but what they do do is they really want to know what their family  members want and when they don't know, they tend to err on the side of caution, which is non-donation rather than donation. 

The second component which may be less interesting to you, but I thought you should be aware of, is what happens between hospitals and organ procurement organizations.  This is a very important component to organ donation because remember, people are brought into the hospital, mostly — 99 percent of potential donors are located in the intensive care unit.  Somebody has to recognize that that patient is potentially a donor and the current regulations stipulate that then the OPO needs to be called by the hospital and the OPO needs to come out and make an assessment and is responsible for making a request to the families of the patient.  So obviously, if the hospitals don't do their part, there are no calls to the OPO.  Therefore, there is no organ donation.

So you can't ask family if nobody knows they're eligible and what we've seen in our studies is that hospitals, at least level 1 trauma centers where most of these donors are located, are reasonably good at it and between 70 and 100 percent in our studies actually will correctly identify potential donors.  However, the next step is that somebody needs to call the OPO on a timely basis.  It's not enough to call the OPO after the patient has been removed from supports and that happens quite frequently, where they'll call and say we have a potential donor, however, the family has left the hospital.  However, the family has already decided to remove the patient from life support, or we already have, too.

So you may be at the letter of the law, because the law doesn't stipulate, but you're certainly not complying with the spirit of the law because if you don't refer in this way, again, the family doesn't have the opportunity to consider this.  Now, we could consider this from a purely utilitarian thing, which is that, you know, we want people to recognize donors because we have a utilitarian purpose for it, but we could also consider it from a consent issue, which is that this should be something that all families have an opportunity and a right to consider.  They have a right to refuse but they should have a right to consider it if it's pertinent.  So what we've found is that timely referrals are even more variable than identification and there are actually some hospitals that never refer on a timely basis and some hospitals are very, very good and about 90 percent of the time they will refer on a timely basis. 

Now, the last component, and in some ways what may be the most important component, is what happens during the request process.  In other words, who asks the family, when do they ask, how do they ask, how much time is asked and I group that under the rubric of what I call effective communication and I've given you a definition of effective communication which is truly essential for obtaining consent.  It entails discussing the option to donate with families in a way that provides them with sufficient information to make an informed decision within an environment that maximizes their ability to consider the request.  Requests can be persuasive but not coercive.  And of course, I'll leave you all to debate that issue.  I'm not going to do it myself.

So what happens during the process?  Well, again, we're looking at critically ill patients, patients who are terminally ill.  They're on complete life support.  Their brains are either ceasing to function or no longer functioning.  So clearly, there's a lot of things that have to happen and one of them is preparing the family for the patient's inevitable death and also trying to make a donation request while that all is occurring.  What I want to talk about and sort of point out to you is the things that can happen during that process that make it more or less likely that families will donate.

Families are more likely to donate when they understand that the patient's condition is hopeless.  They're more likely to donate when the possibility of donation is raised once the likely terminal nature of the patient's condition is known, not after they've declared the patient dead, brain dead, not after the family has decided that they want to remove life support but before that, once they know that the condition is futile. 

Now, the interesting thing is that I believe the family should all have a good explanation of brain death for them.  However, what you should know is that understanding brain death is not associated with consent to donation.  In fact, in our studies of families who've considered requests for organ donation, what we found was that more than half of those families really did not understand the concept of brain death, didn't really understand whether the patient's organs were taken before or after they had technically died, and were more likely to donate when they said that they were unclear when the patient had died.  And I can discuss that further, I see some people's knitted brows about this, but those are the results.

And again, people make their own judgments about life and death.  They often don't use our medical concepts of death.   We often would hear families say things like, "I know that they said they were dead at this time, but the minute I saw them in the hospital, I knew they were gone."  For them, that's when the patient died.  The other thing is that we talk about the use of relational communication techniques to make those requests and these are the sort of things that always should happen in healthcare settings with families of patients, whereas you have to build rapport with the family and the family's values and the patient's preferences concerning organ donation have to be solicited and actively listened to. 

Certain types of information are very important to actually making an informed decision, and this list is from empirical data, where we know that understanding these issues makes a difference as to whether somebody donates or not.  So for example, it's very important for families to understand and know what can happen in terms of the funeral arrangements for the patient if they donate.  They want to know and need to know how the body is treated.  They need to know what the benefits of donation are.   It's hard to make decisions about things if you don't know what are the good things that could happen because you donated and there's often an assumption that everybody knows this but it's not, there's an assumption that people that know that there's only about 12, 15,000 individuals in the United States that die, are brain dead every year.  They don't know that.  A lot of people believe that if they don't donate, well, the person in the bed next to them can donate and that's simply not true.   So we need to give people real information for them to make a really informed decision.  They need to know that if they choose to donate but they don't want to donate certain organs, that they have the right.  The need to know what the monetary cost will be for them if they donate.

The need to have reputation of certain myths about donation, such as that the body is mutilated as a result of donation and we need to actively solicit again, the patient's wishes and if it's a first person consent state, to check the donor registry.  The time spent with the family is very important and families need a lot of time to consider this request; hence, again, it's really important to ask earlier rather than later and they need to have emotional support provided.  So we know that the more time you spend with the family, the more likely they are to donate.

We know that OPO staff have superior consent rates as compared to other health care providers and you need to be trained to do this.  It shouldn't just be anybody doing this.  And they have to be provided with a comfortable environment, again, providing them time and emotional support.  I thought you might be interested to see why people decide to donate and why they don't donate.  What we found from real families who made these decisions is that for people who donated, 78 percent donated because they felt that it would help other people, 75 percent because the patient communicated a wish to donate, 62 percent because they were just kind of generally pro-donation, 32 percent because it would help them cope with the loss of the patient and 22 percent because they felt the patient was gone and they didn't need the organs anyway. 

I want to point something out about this list, which is that it's not a linear list.  Everybody who donated had at least two reasons, mostly three reasons for why they donated and actually, although altruism beat out patient communication, a little, and I'm not bringing the really complicated analysis we did on this, what you should know is that the two reasons that were actually more important than altruism was knowing the patient's wishes, again, acting as a good surrogate and being generally pro-donation.

Now, why do people refuse?  And here the interesting thing is that many people actually had a single reason for not donating, and they were much less complicated about why they didn't donate than why they did.  And again, this whole issue about being the good surrogate, 51 percent didn't donate because they thought the patient wouldn't have wanted to donate.  Now, sometimes that's because they had an explicit conversation.  Other times, they were casting back and just thinking about everything they knew about the patient to come to that decision.  Forty-four percent was something that we call family stamina.  The family just didn't have enough emotional energy to go through the donation process.  They had had enough.  They felt they had been through enough and they just didn't want to go forward with it any more.  And again, I think it speaks to the issue of providing the family with a real environment where they can actually do this.

Forty-three percent had disfigurement concerns, a quarter mistrusted the health care system, 19 percent thought the patient was ineligible.  They were incorrect in that judgment, but they made that judgment themselves and in 14 percent of cases there was disagreement amongst family members.  So technically there is a legal next of kin that can make those decisions, but frequently these are family decisions and most family members will not override other family members, so if a son wants to donate but his other siblings do not, it usually means that they don't donate.

The last — so those are essentially, I think the real issues around organ donation.  That's really a summary of what we really know about why people do or don't donate and the components that are important to donation.  The last two things I wanted to talk about were organ donation in minorities and policy issues.

As you probably all know, minority groups have a pressing need for transplantable organs, particularly kidneys, and just to show you a little poll data, probably the best data we have that compares three different ethnic groups, we know that this one poll said that 87 percent of whites expressed support for organ donation, compared to 69 percent for African Americans and 75 percent for Hispanics.  Donation rates, as I mentioned, are half that of whites and minorities are also less likely to have made a decision of organ donation for themselves and they're less likely to have communicated that decision to a family member.  All those things mean that when we look at this, we should see lower donor rates, and, indeed, we do. 

Why doesn't the African American community donate, and I'm going to concentrate on the African American community, because it's the community we know the most about.  They're the most studied and it's also the community that has an incredible need for kidney donation.  Despite a lot of work, there is still a lack of knowledge about the need for organs in the African American community.  There's also a mistrust of the health care system.  When you look at that quarter of people that say they mistrust the health care system and they didn't donate or don't want to donate because of that, if we look at those numbers for African Americans, it looks more like 40 percent for African Americans, and it's not just around transplantation, it's around the health care system in general.

And then what we know is that African Americans experience different donation requests than white families and I'll just go into that a little more.  What we know happens in the hospital with African American versus white donors is that if you're African American or a member of an ethnic minority, you are actually less likely to be identified by the  health care team as a technically eligible donor.  You are less likely to be asked as a family about organ donation if you are an African American family and in another study what we found was when we asked health care providers to assess whether or not families were pro, wanted to donate, didn't want to donate, or were undecided, they were markedly more likely to misconstrue the intentions of African American families as not wanting to donate even when they did want to donate.  So, again, I think there's a lot of stereotyping going on.

And then finally, I wanted just to talk a little bit about policy, and of course, I don't have to tell all of you the procurement system is voluntary and it relies on the public to give gifts to a publicly regulated and funded system for organ donation and the system has only sort of minimal oversight for tissue donation.  I think there's an assumption, is that we can all be asked to donate for the public good and there's a community based organization, those organ procurement organizations, that are responsible for procurement.  I think some of the issues that need to be considered are that there are significant numbers of people who actually donate in this country, who if they themselves needed an organ could not receive one because of financial issues.  So that we do have a system that's publicly funded.  We do want everybody to donate for the common good but not — everybody can give but not everybody can receive.

Over the years, there's been all sorts of policy and legislative approaches and usually I start most of my talks with noting the number of people on the waiting list.  There's currently about 93,000 people on the waiting list at UNOS.  When I first started working in this area in the 1980s, there were 25,000 people on the waiting list, it was considered a crisis.  As a result, we passed required request laws that said that the hospital is responsible to make sure that they asked all the families of donor eligible patients.  Those laws did not really result in the increase in donation that we had hoped. 

The next set of legislative responses was routine notification which is our current system.  It basically says that the hospitals need to call the OPO who need to come in and request organ donation.  That has bumped up the rates of notification and identification so that we've been able to get more organs but the actual consent rates are still the same, they're about 50 percent.  There have been some hospitals that belong to something called the collaborative that have done much better but still, overall the rates are a little better but they're not great.

The next thing has been state initiatives for first person consent where we have binding registries.  Those registries are great as long as when we request those, people are given complete options about what they want to donate.  So for example, in the state that I live in, in Ohio, you just have a blanket check and a lot of people don't realize that that includes tissues as well.  A lot of people never thought about that, so that could be a problem in registries. 

There have been suggestions for mandated choice, that everybody is required in this country to choose.  They tried that in the State of Texas.  It didn't work very well.  Everybody just opted out.  Presumed consent, which is a European system, which presumes that everybody wants to donate unless they actively opt out.  They tried to pass that in Pennsylvania in the 1990s.  That failed legislatively and as I will show you, it doesn't have a lot of public support and then financial incentives which the Institute of Medicine dealt with recently. 

And just a last slide and I'm done, just to give you an idea, most Americans do not favor presumed consent laws.  The majority of Americans are against those types of laws.  They think they go against people's sense of autonomy and again, there's fears and mistrust about the health care system.  The overwhelming majority of Americans though did agree with first person consent laws so they're comfortable with those laws as long as you can document that somebody really does want to donate.  Half of the Americans believe that it's acceptable to provide donor families with money for funeral expenses and many more African Americans than whites favor such a policy, which is interesting.

And only a third of Americans don't favor any other type of financial incentive.  So in terms of financial incentives, funeral benefits actually is an acceptable financial incentive for most Americans.  Anything else is not proven to be.  And then lastly, less than half of Americans believe that donors should be able to designate a recipient.  Most Americans are uncomfortable with that idea, that you should be able to say, "Well, I want to give my relatives organs to this person rather than this person or this type of person rather than that type of person."  So, thank you very much.  I'm sure you'll have some questions and I believe my time is up, thank you again.


CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Siminoff for this fine overview of the socio, cultural and ethnic dimensions of the process and the perspectives on organ donation.  Next we will hear from Dr. Neil Powe —

DR. POWE:  Powe.

CHAIRMAN PELLEGRINO:  Powe, thank you very much, Professor of Medicine and Epidemiology and Director of the Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University Bloomberg, School of Public Health.  Following Dr. Powe's presentation, we will open up the discussion.

DR. POWE:  Well, I want to thank you for the privilege to come before you today to talk about a subject that's near and dear to my heart.  I was asked to come to address the need for organs, whether there actually, truly is a crisis in this country or even in the world in relation to the need for organs.  So that's what I intend to do.  I'm sure you've seen statistics like this.  And I am going to show some slides today.  I cannot ever do a presentation without data.  I live in data every day, but I hope it's not too — these statistics are not too troublesome.

This shows the number of people on the wait list.  As Dr. Siminoff has said, there's about 90,000 people now on the waiting list but only 26,000 transplants and 14,000 donors in the country.  And you can see there's a widening gap over time.  So what I'm going to talk about is the growing prevalence of chronic disease.  I'm going to talk about kidney failure, an area that I've worked in a lot and a little about heart failure; the prevalence and incidents, the causal — something about the causal factors driving this, treatment and prognosis, quality of life and cost, and show you data by different transplants of the waiting list and then summarize this.

So chronic disease is a disease that lasts a long time.  Chronic diseases are unlikely to be cured in the near future.  Progression can lead to organ failure, that is what we often refer to as end stage disease.  And this is true in conditions like diabetes, hypertension, heart disease and kidney disease.  You can see there are about 58 million total deaths in the world each year.  And it's believed that 35 million people die from chronic disease.  That's 60 percent of all these deaths.  And that chronic disease accounts for about 75 percent of health care spending and, in fact, that's due to increase even more because of the older — the aging of the population.

And some chronic diseases and their antecedents are increasing, so you all know that obesity is increasing.  Obesity, then, is a determinant in the increase in diabetes and diabetes is a principal cause of chronic kidney disease.  So when many look at the causes of chronic disease, they are multi-factorial.  They include underlying socio-economic, cultural and political and environmental determinants, and then common modifiable risk factors such as health behaviors, other healthy diets, physical activity, tobacco use, and the non-modifiable risk factors, age and genetics.  They also include intermediate risk factors, such as blood pressure — rise in blood pressure, blood glucose, abnormal blood lipids, and then overweight and obesity as I mentioned and these are determinants in many of the chronic diseases that we see today. 

But we don't know what those — how those determinants interact or even how to best intervene.  This shows again, data on — current data on the number of transplants and waiting lists.  You can see the kidneys are far the group that is one of the largest in terms of transplants and in terms of the waiting list and then followed by liver and then smaller numbers for pancreas, heart and lung. 

So let me talk about kidney disease, an area that I've worked in the last 15 to 20 years in my career at Johns Hopkins.  And there's a huge public health burden in chronic kidney disease.  There's over 400,000 people in this country are treated for end stage renal disease and the cost of that treatment is about $50,000.00 per patient per year, an aggregate cost to the Medicare program of $17 billion a year.  And you can see this graph that I've put together for you that shows in 1972, our Congress decided to pay under the Medicare program for patients to receive dialysis or transplantation for end stage renal disease, probably the only disease in the history of our country that was paid for particularly on a disease specific basis and there were about 17,000 patients in the first year of the program and that's now grown, as I said, to 400,000 patients.  And you can see this is a growing chart and the cost associated also growing.

Well, this 400,000, this is a little old slide, it was 300,000 when I did this a couple years ago, is fuel.  It's only the tip of the iceberg because recently we've been able to show in the population by one of my colleagues, Joe Korsch, that there's a large number of patients who are in earlier stages of kidney diseases, about 8 million individuals in this country who have what we call Stage 3 chronic kidney disease and this is marked by something that we call glomerular filtration rate which we measure through blood measurements.  So this is something that we haven't seen yet and probably what's fueling this 300 or 400,000 patients who have end stage disease.  And so when people try to project this out, this is what we end up with.  By 2010, it's thought that there will be about 600,000 patients in this country.  This has been a two-fold increase of prevalence over just a decade and it continues to rise.

Well, what's the reason for this, well, the aging of the population as I mentioned.  Kidney disease is associated with age.  The most common cause of kidney disease is diabetes and we know diabetes is fueled by obesity, another epidemic in our country.   And as Dr. Siminoff said, the racial characteristics of who gets these diseases is also staggering.  African Americans are about somewhere between three to seven times more likely to develop chronic kidney disease.  What's less certain is whether there's been improved survival of individuals treated by therapies like dialysis and transplantation or whether, in fact, we're seeing people with kidney disease because we're saving them from other diseases like heart disease, cardiovascular disease treatment.  Some of my colleagues and I have tried to tease that out but it's very difficult.  This shows the epidemic in the minority community.  African Americans have a much higher incidence than whites and also Native Americans because of high rates of diabetes in Native Americans.  That's also true that Hispanics have a large degree of  ESRD. 

Some of my colleagues and I, we've tried to explain why there is this excess risk of chronic kidney disease in African Americans.  I think it offers some illustrations of the causal factors that may be at play.  This slide shows the relative risk of  blacks versus whites, greater than — Blacks are almost two to three times more likely to develop end stage renal disease.  What we control — that's controlling for age and sex.  If you control for socio-economic status you can explain 12 percent of the excess risk.  If you control for lifestyle, about 23 percent of the excess risk and if you control for the care they receive, medical care they receive, about 32 percent of the excess risk.  But all these factors together, you can explain almost 50 percent of the excess risk.  That's good news because lifestyle and care quality we can do something about but there's still 50 percent of the excess risk that we don't have a clue as to why.  And so more work needs to be done to understand that. 

Well, what is it like to have end stage renal disease?  These are some pictures. There's two ways to treat this.  One is dialysis and one is transplantation.  If you get hematolysis, this is what you get.  You spend 12 hours of your week, four — three times a week visiting a dialysis facility, tethered to a dialysis machine.  You can sit, watch TV, read but you're there for 12 hours for the rest of — 12 hours a week for the rest of your life.  Some patients choose peritoneal dialysis where they — instead of getting their blood filtered — the impurities filtered from their blood, they do it through their abdomen and they do it at home on their own, and hooking a bag of solution that goes into their abdomen and then we drain that out by gravity.

Some patients do it at night using a machine that actually cycles the fluid into the belly and out.  I've studied a lot of the quality of life and mortality of different types of dialysis and there are differences but the main difference is that if you're lucky to get a transplant, you're much more likely to live, 80 percent survival over five years versus if you're on dialysis less than 50 percent of patients who undergo dialysis are alive in five years.  So really getting a transplant makes a difference.          And the risk is not — it's different over time.  There's a higher risk of death in the early stages of transplant.  There's the risk of the operation but over time, the risks of death go down.

What's quality of life like?  Well, we've studied chronic kidney disease in patients, asking them about their quality of life.  And it turns out on average, about 30 percent — on average, they're willing to sacrifice 30 percent of their remaining life expectancy for good health.  So they're willing to trade off some time for an improved quality of life, a significant amount of time.  They also had many other comorbid diseases and complications which go with kidney disease, meaning they're hospitalized about two times per year and they take on an average seven to 14 different medications a day.  This also shows what it is in expenditures comparing dialysis to transplantation and actually transplantation here is cadaveric and living related transplantation costs more in the early part due to the operation but over time — this is the dialysis cost, about $50,000.00 per year, but over time, you can see that actually transplantation is less expensive in the long run than dialysis. 

And so this is — this epidemic of kidney disease is why we have this disparity of people waiting on the waiting list, 60,000 patients waiting for a kidney and only 15,000 transplants being available, most patients, as I said, being relegated to dialysis. 

Let me say a little bit about heart failure.  Heart failure statistics are very hard to come by.  Part of the reason is that because Medicare has paid for kidney disease in this country, we have very good statistics on who gets — who has the end stage disease.  It's not as true for heart failure, but this is what people have been able to glean and put together.  There's about five million people with heart failure in the country.  That's heart failure of any severity, about a half a million people who develop it each year, 57,000 patients who die each year.  It accounts for about a million hospital discharges.  In fact, it's the number one reason in the Medicare population for hospital discharges at a cost of about $30 billion to our country.

The prevalence of heart failure varies by age, about 10 percent in those over age 70 compared to two percent if you're less than age 60.  And the determinants of heart failure are largely those who have ischemic heart disease or coronary heart disease, accounting for about 70 percent of cases of heart failure.  In fact, most people believe what fuels this is that we've developed very good therapies, kind of half-way technologies for treating heart disease, revascularization therapy, whether that's thrombolytic  therapy, clot busting drugs, or coronary artery bypass graft surgery or stents, that actually save people's lives but they actually leave the heart muscle still damaged and so that leads then to progressive heart failure.  And because of that, we can keep people alive but patients are going to go on to develop heart failure.  In fact, we see deaths from heart failure increase over the last few decades. 

The prognosis for heart failure can be poor.  It's a progressive disease.  Yearly survival depends on what class of heart failure, kind of stages of heart failure that we use.  If you're in a mild class, it's — the yearly survival is about 85 to 90 percent, but it goes down to 50 to 70 percent if you're a Class 4 and this is about a quarter of patients.  Those patients that have refractory symptoms at rest meaning they're short of breath at rest, they would be candidates most likely for transplant, have a 50 percent survival of just six months.  So their survival is really poor.  And as I mentioned, it's the number one reason for hospital admissions in the Medicare program.

How do we treat heart failure?  We can treat through medications, a lot of emphasis in the last few years on disease management, education, case management, prevention efforts, exercise training and then our technology.  Implantable defibrilators  are now, biventricular pacing is shown to give hearts a boost in their pump function.  And then mechanical support devices mostly now used as a bridge to transplantation but not in and of themselves long-term therapy.  And then transplantation, which has been really reserved for less than five percent of those with advanced heart failure get transplantation but I expect this actually will grow.

This is what the heart waiting list looks like.  We're seeing a little decline in the waiting list, probably because we're getting a little bit better at the eligibility characteristics for those who are eligible for transplantation.  Patients with heart failure at least Class 4 heart failure, have a miserable life.  If you ask that same question I said to dialysis patients, those with end stage renal disease, the Class 4 heart failure patients are willing to sacrifice about 70 percent of their remaining life expectancy to have perfect health, trade that amount of time off.

So back to this slide, this 90,000 people on the waiting list, I think it's real.  I think there is a crisis of chronic disease an end stage disease in this country fueled by a variety of factors that we don't understand and they're increasing.  We, as well as others, are trying to understand why this is.  I think preventive efforts are extremely important but they're unlikely to immediately address the loss of life and suffering by several hundred thousands of persons each year and as Dr. Siminoff said, the problem is particularly important for some disadvantaged groups in this country. 

So I think this is real, I think it is a crisis and I think we need to do something about it.


CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Powe, for your very, very concise summarization of the very critical clinical data that must figure in any consideration of an organ donation program as well as the data we heard from Dr. Siminoff.  I'm going to ask one of the members of our Council, Dr. Daniel Foster, to open the discussion of both these papers and then all the rest of the council members, we hope will contribute their observations and questions.  Dr. Foster.

DR. FOSTER: Well, I'm sure I speak for the Council in appreciation for both presentations.  Let me begin with the first presentation to ask a question in what might be called a reality response to the summary of all the things that lead to and lead away from donations and that question has to do with the issue of time.  Almost everything that you said focused in terms of preparation for time, we have to start early if we think that there might be an illness that would lead to a donor.  We have to spend much time with the family at the time of the event and one of the absolute realties that all physicians deal with now is the lack of time because of payments and all sorts of things that — follow-up visits in the office which might have been 15 minutes are now five minutes.           It's standard for a new patient work-up in internal medicine which for years was an hour is down to 30 minutes or 15 minutes or less.  So hovering over everything that you have talked about is the pressure of time.  Most physicians, even really caring physicians, are not going to be able to spend an hour or two hours with a family regarding donation.  I mean, it might take — I'm actually involved in one myself right now.  There's just not time to go over all of these issues, to talk to the siblings, to do all of those things. 

Another matter of time is that many of the deaths come quickly, if it's trauma, you're riding a motorcycle without a helmet and so forth, and so there's a time element which is involved there.  And finally, there is the issue that most of the time the trust is involved if there is an ongoing relationship with the physician, for the physician to be there, but in most hospitals, death, even — certainly random deaths come with the physician of record not being there at all, so it's going to be a resident or something of that sort.

So I think that what I'd like to open the discussion with is your response to how do you think that we're going to have time and resources to do all these things, not to mention the proposals which we'll talk about later, the IOM report and so forth, for starting education very early in life and so forth.  I wonder if you would just comment on that reality factor.

DR. SIMINOFF:  Yeah, and I agree with you and I think one of the reasons in our studies physicians have the worst consent rates of any health care professional is because they do not have the time to sit with the family and do what really needs to be done.   Required request laws failed because they gave that responsibility essentially to the hospitals and to the physicians to do.  The current regulations, however, don't really stipulate that the physicians or even the hospital staff have to have that responsibility. 

Currently, what is supposed to happen is that somebody from the hospital needs to tell the organ procurement organization that there is a potential donor.  It then becomes the responsibility of the OPO to do that, to spend the time with the family.  So really what really needs to happen and the most successful hospitals, the most successful models of this are when the health care providers call early, the organ procurement organization staff that's trained to do this comes early.  The health care providers are then responsible for making the introduction.  They do not have to stay for the entire thing,  In fact, mostly they do not and then they leave and the OPO staff are then the people that will spend the hour, the two hours, sometimes the 12 hours with this family.  Otherwise, you're absolutely correct, there's no way physicians could do this, and they weren't doing it and they weren't able to do it.

And so now really, what I think needs to happen in hospitals and particularly for a lot of intensivists who care for their patients, they really need to start becoming comfortable with doing this, with saying, "We really can't do this, it's just impossible for us.  We need to give this responsibility to somebody else understanding that we have hopefully a good relationship with these people," and that was sort of the second element of developing that relationship of trust between the hospital and the OPO and then feeling that when I introduce this staff — this OPO staff person to the family, I can feel confident that they will treat this family with respect and with sensitivity and that they will do a good job.  So that is really where things are going and I think need to go given the constraints.

And again, when you mentioned sometimes things happen very quickly medically with these patients, again, that's the other reason why it's very important for the OPO to be called quickly.  Now, there are some different models.  For example, in some very, very large level 1 hospitals they've put in what they call in-hospital coordinators.  These are people from the OPO and their job is to be in that hospital 24/7 and that's what they do.  So basically, the OPO always has somebody on call at that hospital. 

Now, as a model, that works very well in extremely busy trauma centers.  It's not a financially feasible thing to do in level 1 trauma centers that have maybe some donors a year but not on a regular basis, then we're back to the calling early thing.

DR. FOSTER: Well, the teaching hospital that I work in, in Dallas takes care of the poor and largely minorities and so — and the people that — the OPO people that come are actually very good and so forth.  Nevertheless, often times if it's a patient that's under the physician's care, they in responding to that kind still say, "I want to talk to my doctor, you know, to do that."  So that it's pretty hard to eliminate that.  Also, I didn't mention the fact that, of course, in most major hospitals now, hospitalists are there and many of the internists and, you know, family practitioner has turned it over to a strange doctor who is there, which makes it a difficult thing.  But I think your answer is probably the best way we can go as to have that sort of training and to — and big trauma centers, which we are, to have a full time group which would be present.  So I think that's something we're really going to have to think about and the cost. 

I don't want to dominate things, but I want to ask Dr. Powe one question about his presentation then we'll throw it open.  The issue of the increasing number of patients with end stage renal disease and as you point out, almost all of them do die of heart disease, they've all got endothelial dysfunction.  I mean, we're going to have to figure out what's going on with that.  The estimates of how many physicians one needs in the country vary.  You know, we go through these cycles, well, we have too many physicians and therefore, we have to stop training programs and now the estimate is, well, there's going to be a great shortage of physicians.  Our own State of Texas has mandated that the medical school increase their entering classes much to my distress, 20 percent to increase the residencies and so forth, just to increase the doctors in Texas.

We're coming to a time where the nephrologists are reaching retirement age, the people who have gone — you know, when you first started this specialty and so forth, and so there is also, I believe, a considerable concern about having enough nephrologists to deal with this massive increase in renal failure, which, like you, I think will continue to increase.  I wonder if you would comment about, not the need of an organ which we're going to discuss, but the need for somebody to care for all these persons who live longer and they're more sick and go into the hospitals much more frequently if they're on dialysis than those who have had a transplant.

DR. POWE:  I think actually, it's not really the patients who have end stage disease.  I believe actually the numbers — there have been, actually a person power estimates or workforce estimates for nephrologists but I'm a primary care physician, a general internist, and it's true that there probably are enough nephrologists in the projections to take care of patients with end stage disease.  The problem comes more of those 8 million that are under the iceberg.  And if all those were to land in nephrologists' office, nephrologists would be overwhelmed so they couldn't take care of the sicker patients.

And so I've actually been doing a lot of work in educating primary care physicians about patients with less degree of renal function in managing where now we are beginning to have drug therapy that can slow the progression of disease, can't eliminate it but slow the progression, things like ACE inhibitors and ARBs when patients are properly chosen for those therapies.  So that's where I think the workforce issues are and probably even more acute for primary care physicians since less people are going into primary care at this time.

DR. FOSTER: Well, just personal experience, I don't have national data on this but at least in Dallas we often times are having to keep patients in the hospital on dialysis because there's no slot for chronic dialysis and if you're a nephrologist in Dallas, I mean, every group is looking for additional people and having some difficultly in finding them.  Maybe they don't want to live in Dallas.  After all the Mavericks lost, but I mean, I do think that there may be even apart from the internists and family practitioners who take care of the earlier stages, that this may be a potentially difficult problem because I don't believe that the renal — I could be wrong about this and maybe Dr. Hippen will want to talk about that, but I don't believe that the number of slots for nephrology training programs are actually increasing and it seems to me that that might be a problem.

DR. POWE:  They're maintaining but then it's what nephrologists do.  If they were to shift more to taking care of the end stage patients more and that was their major role versus the earlier patients, so I think that's the issue of where they work.  I don't want to give the impression — the availability of dialysis is wonderful today.  Most of the units in 1990 were in-patient units but by the end of the early 1990s most of the units are outpatient.  So most of the units are not even affiliated with hospitals but free-standing dialysis units in the community and they have doubled to tripled over the last couple of decades so the availability of dialysis treatment is very good in community centers, often started by now for-profit dialysis facilities.  It's become a for-profit business in this country.  About 80 percent of patients are taken care of for-profit facilities, so the capital to build dialysis buildings and facilities has been there through this for-profit market.

CHAIRMAN PELLEGRINO:  Other questions, comments?


PROF. SCHAUB:  Yeah, I have a question for Dr. Siminoff.  Has there been a generational shift in the willingness to donate?  I mean, are young people more likely to check the driver's license box than older generations?

DR. SIMINOFF:  I don't think we have good data on that, so I really can't answer your question definitively.  What I do know is that when we speak to potential donor families, that as I said, the families of younger patients do tend to donate more frequently.  And those family members tend to be younger.  They are usually making decisions about young adults or pediatric patients.  They, themselves, are younger and they do tend to have more positive views and they've heard about it and they discussed it in school.  So my guess would be if somebody actually did the study and looked at the data, that there is somewhat of a generational shift in this and there has been a consistent rise so that about 20 years ago, I don't think any more than 20 percent of the population had checked something off on their license and that number has doubled.  So there definitely has been an educational shift in the country as people become increasingly aware about this issue.

PROFESSOR SCHAUB:  Do families themselves ever initiate the process?  You mentioned sometimes —      

DR. SIMINOFF:  Absolutely they do.

PROFESSOR SCHAUB:  — in hospitals —

DR. SIMINOFF:  About a quarter of donor families actually initiate it themselves.


DR. ROWLEY:  I have two questions for Dr. Siminoff.  The first question has to do with that data that we got that I think is not from you that indicated that individuals over 65 are now donating organs where they didn't used to or another way of putting that is that transplant services are realizing that older donors may be of value.   The question is, is there any data available on say the survival of individuals transplanted with organs taken from older individuals as compared with younger.

And so the question — there are two questions, one of which is related to the enormous increase, more than three times, in the period for which we were given data in use of older individuals as donors and the second is the viability of organs taken from older individuals. 

DR. SIMINOFF:  I'm going to somewhat answer your question and then I may punt to Dr. Powe about the medical aspects.  What you're talking about is the expanded donor criteria.  And so that is not so much a consent issue as it just is a willingness on the part of transplant surgeons now to accept donations from people who are older.  And the interesting thing,  I think I showed you is that about 19 percent of families deny donation because they don't believe that their relative was eligible.  Those tend to be the families of these older donors who, when you talked to them say, "I know they asked me but they were mistaken.  They don't understand, you know, my dad was a smoker or my uncle drank a lot and nobody would really want their organs, they're too old." 

So we do need to educate the public at this point that donors are not simply 20-year old men who ride motorcycles without a helmet like in Pittsburgh.  They are many, many other people.  I believe that those organs are viable although I'm not sure they do as well and I think there's been discussion about whether we really should be talking about if we are going to be taking organs from this expanded donor pool, would it be better to preferentially transplant those organs into older recipients, but maybe Dr. Powe has some thoughts about that.

DR. POWE:  Yeah, there's been a lot of work on what we call marginal donors or expanded criteria donors.  Some of those are donors that have high blood pressure, that have been obese, that might actually even for themselves, if they give a kidney, have to worry about their own health in the future, and then whether the actual, you know, kidney will survive.  So the premise with this is that, yeah, with older age a kidney, renal function does deteriorate over time so one, in fact, would think that a kidney from an older recipient may on average not do better than someone from a younger recipient.  That's probably true.  But because we look at the kidney function, you know, and look at eligibility, you know, not every older person is the same in terms of the disease that they have, so that has to be looked at and that's what surgeons do and transplant nephrologists do when the select someone for an organ.

The other thing is that this is a moving target because immuno-suppressive therapy has gotten so much better over the last decade that, in fact, the rejection of organs has gone down and we're getting better and better at that.  So we're extending the life of organs at the same time. 


DR. KASS:  Thank you.  This is a question for Dr. Powe.  And it goes to your sort of projections of what's in store for us even as early as 2010 in terms of the growing number of people with end stage renal disease and presumably, the growing, therefore, number of people on the waiting list unless there is some kind of radical solution to the so-called transplant shortage.  It seems to me that if these numbers are right, we are, in fact, facing this shortfall, the shortfall that we face now is nothing compared to what we are likely to see going forward.          

And that raises for me the question of whether it's right to begin to think of this in terms of a crisis even now, because a crisis calls for really sort of major and heroic kinds of interventions.  Thirty percent AIDS incidents in the male population in sub-Saharan Africa, that's a crisis for a community.  The fact that the mortality rate in the United States is exactly 100 percent is not a crisis.  All of us are going to die of something and I notice from the figures that we were given that on the waiting list already, 60 percent of the people on the waiting list for all organs are over age 50 and 14 percent of them are over age 65.  A sixth of the people on the waiting list for kidneys are 65 and older. 

If we manage some of these other symptoms, lots more old people are going to be transplant eligible as the only way to avoid a demise.  So I guess I would invite you to tell me why you think this is a crisis and a crisis for whom.  It's sad, I don't deny that, but if we start talking about this in terms of a crisis and going forward, nothing short of some kind of radical measures would somehow meet that kind of need.  And I wondered if — that was a bit long-winded, I'm sorry, but I would like to sort of like to invite your reflections, especially thinking ahead.

DR. POWE:  Right.  Well, this is a philosophical issue.  And, you know, as to — you know, when you speak to should all — should those who are older be in the waiting list, have they lived long enough?  And I don't think our society has grappled with that very well and is willing to refuse treatment especially for older individuals that have the means to pay for that therapy.  So I'm not sure I can answer that question.  This is a big issue for our society.  Other societies aren't in the position around the world where they can offer marvelous and wonderful treatments to individuals that we can in this country and so we're faced with this dilemma.

I mean, it used to be that in the advanced stage renal disease industry people in Canada and the United Kingdom, if you were over age 65, forget about getting dialysis, but now that's opened up in other countries, too.  Other countries are going to face this issue in the future, too.  I don't know how to solve it.  It's a rationing issue and an issue about how we deliver health care politically, financially and philosophically.


DR. KASS:  No, I appreciate the drift of the conversation but one thing that is in your power is whether or not to call this a crisis and since you used the term, I'd like to hear you tell me why you want to call this a crisis especially if we ain't seen nothing yet.

DR. POWE:  I think it is a crisis.  When I see, you know, organs being sold over the Internet on E-bay, people desperate to get an organ.  Individuals that I know who have end stage renal disease will do anything to get a transplant from their own family members, too.  That's something we really didn't talk about.  I think Dr. Siminoff's presentation was focused a lot on the cadaveric group but also the living — related living, unrelated.  At Hopkins we're doing a lot of issues around people, if they're not compatible swapping organs with others even if they're unrelated to each other.  These are the kind of things  that are going on today because the pressures of individuals who are — and more individuals that are in this circumstance vying for this scarce organ.  So I think it is going to be a crisis. 

It also depends on where you stand.  You know, if you have a family member that's effected by this or you're effected by it, it is a crisis, there's no question about it.  And the more of us that are effected by it, I think the more it will be a crisis.

CHAIRMAN PELLEGRINO:  Dr. Lawler?  You're on the list, Bill, I'm sorry.  We have to remind you all that we have six more to speak and we have a limited time.  Peter?

PROFESSOR LAWLER:  Let me get the elementary medical facts down right.  In this country we have millions and millions of people who have kidney disease.  Kidney disease is progressive.  It can't be stopped.  It can be slowed down some basically through blood pressure medications, but maybe not all that much in many cases.  So as we improve medical treatment, fend off heart disease and other complications, more and more people are just going to live through this thing and progress to end state or renal failure, right? 

So this is the character of the time bomb that this is a disease that many, many people have.  As medical technology improves, more and more people are just going to see it all the way through.  That is they're not going to die in the process, they're going to die in the end of it, and is that really the nature of the crisis?

DR. POWE:  Well, that's part of it.  We really don't actually understand that.  And I tried to elude to that, part of this is — in kidney disease is driven by the aging and we know that age is associated with kidney disease.  The number one cause, 50 percent of the cases of kidney disease, over 50 percent are due to diabetes, okay.  And we know there's an epidemic of obesity.  So if we could do something about the epidemic of obesity, we might, then slow down diabetes, the whole pathway, but that's going to take years.  It's going to take years and I don't think we know how to do that. 

And then this other issue of technologies that we save people's lives has been less proven although it certainly is a plausible, you know, hypothesis.  I actually believe that as we extend life that's what we're going to be doing but the evidence for it is not ironclad compared to where our efforts should be in terms of other prevention efforts, for example. 


PROFESSOR MEILAENDER:  I have a question for each of you.  For Professor Siminoff, I just wondered with respect to these first person request laws, you know, as it were a mandate that a person's consent is simply overriding, I go into my license bureau to renew my driver's license and they ask me, you know, what color my hair is and I say, well, you know, (laughter) and they say, "Do you want to be an organ donor," and I say, "Yes."  In what sense does that constitute consent?  That's my question for you.

For Dr. Powe, this may not be an answerable question, if you want to just tell me that, that's okay, because —

DR. POWE:  I'm used to those.

PROFESSOR MEILAENDER:  — you deal with — you think about sort of data we have about what has happened.  But I just found myself wondering, I don't know if there's any way for you to think aloud about this question, if in 1972 Congress had not decided to fund dialysis, what would our situation look like today?  I'd just like to hear you think about that if you're willing.

DR. SIMINOFF:  I'll answer the simpler question first.  I agree with you that in terms of we — and again, I live in the State of Ohio.  I took my son to get his driver's permit and I watched what went on and I was appalled.  Now, he's thought about this issue for years because of me but he's a somewhat unusual 16-year old.  The real problem is, is that the driver's bureau is not a very good place to make these decisions. 

Presumably for most people they will have thought about this and had other information.  There certainly are pamphlets that are given to people, whatever.  That's why I eluded to the fact that we need to make sure that we have registries that are; A, accessible to people so that if they change their mind, they can easily do that, that we have good, at least educational literature that gets handed out and that people are able to see all the different things that they could donate and are forced to tick them off one by one.  That will make people really think about what they're doing, you know.

And there are states that do this; they say organs, and they list, hearts, livers, kidney, so you're forced to say to yourself, "Do I want to donate my heart, do I want to donate my kidney," and then it lists all the tissue.  That's why, for example, it's not very good because it's just a very blanket sort of thing.  So I agree, I believe that most people need to give it more thought than they would normally get in the bureau.  I think the presumption has been is that people have thought about it beforehand, that this isn't really where they're consenting, per se.  It's where they're just designating their wishes from a prior thought about it.

And there are many people that choose not to do this, obviously.  They either haven't thought about it so they're uncomfortable checking, or they're uncomfortable checking it and they really prefer to sort of say to their family, "If something happens to me, I would like to donate so now you know."   And I'll let Dr. Powe project the future.

DR. POWE:  Well, there actually is some evidence on the issue.  There was a researcher, Roger Evans, who did an interesting study in the late 1970s and early 1980s and what he did is he looked at the demographics of individuals who received dialysis for end stage renal disease before the passage of the Medicare program and after the passage of the Medicare program about five years later.

And what he found is that before passage, older individuals, those that are unmarried, separated, or divorced, lower income and minorities were much less likely to receive dialysis care or transplantation.  And then five years after the passage of the program, the demographics, those disparities had actually decreased as a result of the offering of health insurance.  You could say this is much the dilemma like the issue of the uninsured in this country today, but at least from an equity issue, if that's important to you, that study would probably tell us what the demographics would look like of individuals if we had not had passage of it who would receive dialysis and transplantation. 


DR. CARSON:  Thank you both for that very provocative presentation and Neil, it's good to see you here.  I have several questions but in the interest of time, will limit myself to one.  Dr. Siminoff talked a little bit about something that seems counter-intuitive and that is that the more information families had about brain death, the less likely they were to donate.  Have you found that, in fact, where the primary decision maker is a physician, that the number of donations tends to decrease?

DR. SIMINOFF:  When you say, you mean people who are in health care who have to make those decisions?  We've never had enough data to really — to look at people in that way and divide it out.  It's not necessarily whether people had more or less information.  A lot of those people had the same amount of information.  It was what they took away from that information.  So there were lots of people who just, despite the fact that they had these discussions about brain death and what it was and they saw things, you know, x-rays of blood flow and this and that, it just didn't mean anything to them.  They just didn't understand it.

And they may not have understood it because it's complicated, and a lot of physicians don't understand it.  So it may be that they didn't understand it because they were very stressed at the time and it was just too much for them to take in.  What seemed to really be important to people was that they understood not the technical issues of brain death, but they understood that it was hopeless for this person and this person would never recover.  That was the bottom line, for people whether they understood that, you know, brain death or not.

Now, it was an interesting finding that when you didn't really understand brain death and you didn't really know the moment of death, you were somewhat more likely to donate.  And that may have been a result of the fact that that was just not an important issue for people.  And we actually did a very interesting study which we published that showed that when we asked the general public about 1300 people what they understood about brain death, they didn't understand a lot and then when we gave them various scenarios ranging from people who are classically brain dead, people who are in a — they're neurologically impaired and they're on life support, but they're not going to ever be brain dead and then people who are in persistent vegetative state, at least a third of the public is willing to donate for people that they know are not technically dead and that was a very, very interesting finding because in reality there is a significant number of people that don't care about these medical definitions.  They have personal definitions of personhood and the soul and a lot of other things that go into it, and so the medical/technical stuff is just irrelevant for them.  So that's the best answer I can give you.

DR. CARSON:    Okay, thank you. 

DR. POWE:  I know of one study, it's not quite related, of an individual, I forget his name, who did a study, did a study of focus groups of physicians about organ donation.  He was interested in disparities, yeah, but what he found is that many of the physicians and health care professionals had some of the same beliefs, surprisingly, that the general public did.  Now, I don't think he asked specifically about brain death but it was surprising that they held some of the views that the general public even though they were more knowledgeable, you know, about health.

DR. CARSON:  And maybe that's the reason that physicians have such poor procurement rates.

DR. SIMINOFF:  That may be. 

CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Carson, for your sensitivity of the time constraints under which we operate.  We have now gotten to the point where I think we have to do some limitations.  We have one, two, three, four speakers on the council who would wish to comment.  May I suggest the following; if you would put forth your questions and ask the respondents to hold off until you're finished and then you take one or two of those.  We're not going to be able to cover all of them, otherwise we will cut into the next session after the break. 

So if you'll allow me to make an executive decision, I will do so.  We won't have a discussion about it, we will do it that way.  So let us have in order, Dr. Bloom, Dr. Hurlbut, Dr. Gazzaniga and Dr. McHugh and then you folks respond as you see fit but brevity is the soul of wit. 

DR. BLOOM: I will just make a comment and  not ask for a response because you've spoken to it in partiality but the bottom of your iceberg concerns me more than the tip that we see.  And it seems to me that the bigger ethical issue for the Council at some point to consider is when do we begin to campaign for preventive medicine and self-responsibility in health and avoid to the degree we can, crises in the future?

CHAIRMAN PELLEGRINO:  Thank you, Dr. Bloom.  Dr. Hurlbut?

DR. HURLBUT: Well, actually, I'd like to return to the question that Leon raised about the crisis and, perhaps we can do that in later discussions.  But it does strike me, looking at the statistics that it's interesting the particularly the live donations that they come primarily from people under the age of 50 and yet there are — the crisis seems to be largely people over 50.  And I just intuitively feel there's something a little worrisome in that relationship, that the young are being asked to donate to sustain the elderly population.  And being over 50 myself, I — you know, I feel the weight of it but still something strikes me as strange.

But I do want to make one comment, and that is since your statistic said that only 40 percent of people actually have indicated a willingness to donate, it seems to me there's a place where you really could make a difference and just a thought, in California we have driving school.  If you get an infraction, you can either pay a fine or go to driving school.  That might provide an opportunity for a much more comprehensive and sensitive discussion and reflection.  Driving school goes on for something like eight hours and they could prepare a very well documented case for donation and give people an opportunity to reflect on both the need for donations and also how the fact that they're in the driving school indicates that they have not been driving carefully and that if they reflect on the fact that they may someday too be disaggregated to save somebody's life, they may drive more carefully as well as donate more frequently.


DR. GAZZANIGA:  I would like to represent the over 65 pro-life group (laughter).  One man's crisis is another man's statistic.  Since we have you here, and since you represent the side of medicine that seems to be seeking increased organs for use, what I did miss was your specific, if you have, specific recommendations for how that might come about and then tied to that question is, do you find various OP organizations at odds sometimes with UNOS and other organizations that have adopted a different public view of the nature of this situation?


PROFESSOR McHUGH:  I was very interested in what both of you had to say from the data and I'm very appreciative of it, but I missed something in your understanding of the problem, not just this issue of the crisis but it's a very similar issue that we used to face when people really cared about autopsy rates.  When I was an intern and a resident, if you didn't get an autopsy the chief of the service was extremely cross with you and he presumed an important thing, namely that you didn't care enough about that family to win them over to understand the anonymous benefits that were going to come from the autopsy were, in fact, part of the relationship that you had with that family and worked with that family to have them understand.

It wasn't simply a matter of information, in other words.  It was a matter of relationship.  And a lot of things that you're saying today about this issue being a crisis, but also the idea that there are people out there that are buying and selling these matters, show me, anyway, that there are problems in recognizing the personhood that's going on here rather than simply the machinery that could be replaced like you replace a transmission. 

You said for example, somebody said here that nephrologists don't work with end stage renal disease, so the best people, the people most interested in this condition of renal disorders aren't working with the serious patients who could be their best advocates because they knew them, not just that they knew their kidneys.  And that likewise we also say that the doctors are so busy now that they can't stop long enough with the persons in the families to give them — so we bring in these advocates for organ procurement.

I don't think that unless there is an understanding that you're grappling with matters of personshood, and personhood here, both from the giver and the receiver, that you're going to do much better than you already have done.  At this rate, I would have thought it's probably what you're going to get for kidneys and probably the best you're going to get with livers, until you stop looking at this in machinery ways, appreciate that the distrust of the health  system has certain coherent reasons for it, people have lots of reasons for seeing the depersonalizations that are going on in there, and I don't think that's so much a philosophical matter as a matter of the system itself and the way we're thinking about these matters like cars.  What do you think about that?

CHAIRMAN PELLEGRINO:  Thank you, Paul.  Would you respondents pick one or two of those questions? 

DR. SIMINOFF:  I guess the last question which gets the grease, I guess.   I think what you said is interesting and certainly there — the first question or mention, the issues of time, and those are very real issues and I think that even though there are many physicians who really would like to sit down and have these discussions with families, they simply are unable to.  I mean, if you look at what goes on in an ICU, I think there's a tradeoff here.

They say here is a patient that I can't do anything more.  They're dead or they're about to be dead and they need to make certain decisions.  Now, I know that we have traditionally thought that it's physicians that really have to do with families and patients, but there are many, many other health care workers.  There are nurses and social workers, and yes, these people from the OPO that are well-trained, do really care about people and really can perform these functions. 

So I guess when I understand physicians who say to me, "I care about this issue, I don't really have time for it and I'm sorry but I just don't," what we've found is that when you have physicians who are that pressed for time, you're better off not having them do it, because they don't do a good job and I mean, I've seen physicians who sort of say, "You know, here's what's going on, they're brain dead.  They could donate, let me know."  Well, that's not a conversation, that's doing an injustice.  So I do think we need to seriously think that there are other health care professionals that can show caring and compassion and provide good care to these families in lieu of physicians.

CHAIRMAN PELLEGRINO:  Thank you very much.  Dr. Powe?

DR. POWE:  I'd just build a little on that.  I don't think it's been in physicians' training to get much training in doing this so a lot of them are even uncomfortable with it and when they're uncomfortable with it, that makes it even more difficult.  The issue you raised about autopsies benefitting, one of the issues that's not clear that if I donate whether I actually benefit.  I think in the living related one there is more of that, "I'm benefitting my family."  And I think that's one of the things to consider, you know, is should there be incentives if I donate and I need something in the future, is somebody going to, you know, step up to the plate, you know, for me or for my family.  And I think that's one of the issues around incentives. 

You know, I guess the other question that has been raised is how might we make available more organs.  Well, I think people have looked at this, you know, in the cadaveric issue and the living donation.  A lot of people think we should push living donation as far — that's not even as far as it should be, that, in fact, when families have an affected individual, they can't find anyone in their family who would step up or feel comfortable.  And so there's been interventions now that have been tested, trying to be tested in the living donation category. 

And you know, as you know, the biggest thing now is really whether there should be incentives, whether it's non-monetary or monetary incentives for cadaveric donation is a big issue and something, I think, the Committee has to wrestle with.

DR. SIMINOFF:  Just one thought about that, for the first time, living donors surpass by just a little bit the numbers of donors from deceased donors.  So deceased donors is actually a smaller component.  I actually believe that living donation, it's not that it's not a good thing, but we have to recognize that there are real risks to the people who are donating and so it seems to me that we're morally obligated to make the deceased donor system the best we can so that we can maximize the donors that we do have from the deceased who, after all, at least according to most of our understanding do not need those organs any more, so that we can diminish the risk that we're asking people who are living to undergo.  

So I actually personally believe that although I'm certainly not against living donors, I think we actually have a moral obligation to maximize the deceased donor pool so that we can put as few people at risk as living donors as we can.             

CHAIRMAN PELLEGRINO:  Dr. Powe, one more, we have just a few seconds.  Go ahead.

DR. POWE:  Okay, let me see if I can — the first comment was a comment about should we be campaigning for more preventive help and that's what I do, but — and I would applaud that.   However, I don't think that's going to do much in the next 10 to 20 years.   I mean, maybe we can get there.  By then we should do that.  We should be looking forward.  I think we need a multi-pronged approach here but there's going to be a lot of problems between now and when we get there.  So I think we have to do something here and now. 

The other comment was about live donations in the younger, kind of subsidizing the older's health.  Interesting.  I think in a live donor it's a different issue because it's often family members and yeah, you know, my mother just turned 80 if she needed an organ, would I step up to the plate?  I probably would step up to the plate.  So whether that's true in the deceased donor or whether you even have control over that is an issue.  So I think — I'm not sure there's anything wrong with that in the living donation category.

CHAIRMAN PELLEGRINO:  Dr. Siminoff, one more.

DR. SIMINOFF:  Yeah.  In terms of that whole issue about the people who are over 65, I think that being over — as I get closer to it, I think being over 65 now is surely not what it was 50 years ago.  I think people are certainly — despite chronic disease, I think people are certainly healthier and are leading more active lives.  I think those are issues about rationing.  When we initially rationed dialysis, we had huge problems.  We had huge inequities and I'm uncomfortable with the idea that just because you're 55 or 60 that you're somehow less worthy than if you're 12. 

I mean, of course, the death of a 12-year old is a tragedy but for the family of a 60-year old, the death of a 60-year old can be equally a tragedy.  I don't know how we weigh that and I guess that's why we have a President's Commission to do that.

DR. POWE:  Yeah, and the system today, I mean, children are preferred.  They're more privileged in the current system in terms of getting transplants and many of the children — most of the children who have end stage renal disease, you know, eventually gets transplants.  The waiting time is much less for those individuals and I think that's appropriate.

DR. SIMINOFF:  And remember, there are size issues.  So you can't take the kidney or the heart of a six-foot man and put it in a six-year old child.

CHAIRMAN PELLEGRINO:  Dr. Powe, Dr. Siminoff, thank you very, very  much.  Council members, thank you also. 


CHAIRMAN PELLEGRINO:  I want to thank you all for your forbearance on the time limitations.  We will extend the rest period until 11:00 o'clock.

(A brief recess was taken.)


CHAIRMAN PELLEGRINO:  Attention.  All right, thank you very much, those of you who are seated.  Thank you very much.  Thank you for reassembling, thank you very much, all the Council members. 

We move to the second session from the empirical data, the sociological and the numerical and clinical data, we move to another area from the literary and the anthropological and the philosophical sense, views of organ transplantation.  And I'd like to call on our first speaker for this next session, Mr. Thomas Lynch, the author of "The Undertaking, Life Studies from the Dismal Trade and Bodies at Motion and at Rest."  Mr. Lynch.

MR. LYNCH:  Well, thank you, Doctor, and thank you for the invitation to be here.  I want to thank Dr. Davis for that invitation and I was asked to hold court for about a half an hour and then there will be questions and answers.   I'll endeavor to hold court for a little bit and on the subject of questions and answers, I should say that I look forward to them so that we can go in the direction of your interests as well as mine.

I should also say that I cannot be offended. I've raised teenagers, so I'm thin-skinned, but amply padded so ask away.  (Laughter)  I embalm and do sonnets and I'm happy to entertain conversation between those subjects and if I don't have an answer, I'll make something up. 

But I thought I'd take advantage of the audience and start by reading a poem since we are considering literary aspects of organ procurement.  And some years ago I was asked to — as part of my indenture to a British publisher, to do a reading at Guy's Hospital in Central London in what was called the Old Operating Theater.  It was, I think an 18th Century amphitheatric room with, you know, few props.  The only thing that they had there was you know, a wooden table with some sawdust, a bucket and blades.  I think maybe this is familiar to the medicos among us but for me they thought it was particularly apropos, because I'm a funeral director, they thought I'd be really comfortable there.  Don't you just love them for those types of considerations.  So this is a piece called, "The Old Operating Theater, London, All Souls Night."  It's taken — there's a part of it taken from that lovely passage in Genesis where Abraham has that dream about becoming the father of a nation, you'll remember this.  There's the good news, A, he's going to be the father of a nation, and then the bad news, at least if you're one of his tribe's people, that everyone must be circumcised, at least the men.  And I always tried to imagine the number of them running off into the desert on that morning when he first announced this Old Testament to them.

"To rooms like this old resurrectionists return the bodies they had disinterred.  Fresh corpses so fledgling anatomists could study origin and insertion points of deltoids, pecs, trapezius and count the vertebrae, the ball and socket joints and learn the private parts and Latin names by which the heart become a myocardium, the high cheekbone a zygoma, the brain less prone to daydream is a cerebellum, and squirming in their stiff unflinching seats apprentice surgeons witnessed in the round new methods in advanced colostomy, the amputation of gangrenous limbs and watched as Viennese lobotomists  banished the ravings of a raving man but left him scarred and drooling in a way that made them wonder was he much improved.  But here the bloody masters taught dispassionate incisions, who to suture and remove.

In rooms like this the Greeks and Romans staged their early dramas.  Early Christians knelt and hummed their liturgies when it was held that prayers and penance were the only potions.  Ever since Abraham guided by God first told his tribesmen of the deal he'd made, their foreskins for that ancient covenant.  Good medicines meant letting human blood.  Good props include the table and the blade.  Good theater is knowing where to cut."

So I read that in part because it introduces us to this morning's considerations of bodies and body's parts, their uses and abuses, the issues of function and dysfunction, mortality and vitality, pathology and personhood, the living and the dead.  These are topics that have always interested me.  And the language of these issues, words like harvest, procurement, consent, donor, recipient and more lately, seller, buyer, agent, this is the language of the farm and market, of the foundation and institution and suggests a set of long established guiding principles or corporate policies and longstanding ethical standards. 

We talk now of future in the cadaveric tissue and organ markets as if we were talking about crude oil or soy bean futures, and suddenly we seem, we human beings, to quote from the songwriter Rufus Wainwright, "to be so many cubic feet of bone and blood and meat and nothing more."  My experience as a funeral director for the past 35 years, as the son of a funeral director for the years before that, as the brother and — brother of funeral directors and father of funeral directors now has taught me just the opposite.  That we are more than the sum of our parts.  And furthermore, our parts, our limbs and organs and remains represent more than remnant or accessory or fragment.  When speaking about human bodies the part is an essential portion, not an accessory, of the whole and it's precious to the owner whether the owner is the body in its current incarnation or the surviving bereaved family. 

My experience with bodies and the parts of bodies over the past 35 years has taught me that our dead are precious to us because ours is a species for better or for worse, that has learned to deal with death, the idea of the thing, by dealing with our dead, the thing itself.  I'm borrowing here, I think from Wallace Stevens who makes the distinction between the idea of the thing and the thing itself.  And it casts me back in imagination to, depending on what channel you're watching at night, 40 or 50,000 years ago when the first human widow awakened in that cave to the dead lump of protein next to her and said something on the order of, "My he's very quiet this morning," or words to that effect.

But depending on the season and the weather, sooner or later she would begin to sense, actually, she'd being to smel,l that this stillness was a different stillness than he or she had ever experienced before.  She knew she'd have to do something about it.  Ours is a species that deals with the idea of death by dealing with its dead.  She knew she'd have to leave the cave to him in which case, I suppose, it would become his tomb.  Or maybe she thought she'd drag him out by the ankles and kick his sorry self over the cliff, in which case we could call him "consigned to that oblivio" or maybe she'd build a fire and burn his body, or maybe she'd scratch a hole in the ground and tip him into it. 

Whatever she did, whatever oblivion she consigned him to 40 or 50,000 years ago, it was the questions that quickened in her looking into that void that became, I think, the signature of our species that separates us from rock bass and rhododendron and cocker spaniels and other living things that die.  As someone quite rightly pointed out and you can try this at home, the numbers are convincing on this, hovering as they do around 100 percent.  But that is a sadness, whether it's a crisis is for us to discuss.  But looking into whatever oblivion she consigned that first dead thing to, she asked the standard questions.  I hear them asked by widowed people today: "Is that all there is? Can it happen to me? Why is it cold? What comes next?" 

So ours is a species that for better or for worse, while the dead do not care and you can try this at home, too.  I've spent a fair amount of time around cadavers, corpses, dead neighbors, dead friends and family and never once has one of them said anything like, "I want the blue pinstripe suit or the cherry casket or the mum plants, please in my behalf."  They say nothing.  They are mum on the subject.  The dead don't care, you can take that to the bank.  But the dead do matter.

They matter to the living in ways that we're only beginning to understand.  And so part of the considerations here as you discuss bodies and the parts of bodies, I would encourage you to take on more of the notion that whether we are talking about the parts of bodies of dead gangsters, buried maybe in Milford, Michigan, as we found out last month when they went digging for whatever is left of whatever remains, whatever might be there of Jimmy Hoffa, at Hidden Dreams Farms, or whether we are looking for our dead at fresh kill landfill site after their murder is commingled, their bodies are commingled with the act of their murderer on September 11th in our great cities, that the dead are with us.  We are all haunted — properly and happily in some cases — by not only their memories, but by their remnants.  I have seen this not only in consideration of organs transplanted or tissue donated, I have seen this in how we consider fetal deaths, expectancies, the whole notion that has fueled the... our concerns over the abortion and reproductive rights conflicts in this country over the past 30 years, just like the ones that are fueling the ones about so-called "assisted suicide," are based on the notion of when death happens and when life is.

And there is a difference, as one of your panel pointed out, between the notion of medical death, metabolic death and the notion of social death and spiritual death and actual death as far as your family is concerned, and those are the things this council must wrestle with when you seek to set forth useful policy.  I might know, for example, that at the end of a process with cremation, we end up with say 14 pounds of bone fragment and dessicated tissue that we can put in a box and hand to the family.  But when you see the elderly sister come to claim the ashes of a sister whose own children couldn't come and get her, when she bears that box like Viaticum, when she walks out the door, flips the button to open the trunk and then reconsiders and goes to the back door and opens it up and then thinks better of it and closes it again, when she goes to the passenger — front seat passenger door, opens it up, places the box on the front seat and then clicks a seatbelt around it, you can see that whether we are remnant or icon or relic is not up to you or me.  It's up to the living that bear us in their memory and in fact, that bear our mortality because we are mortals, we are humans.  We are tied to this humus, this layer of earth from which our monuments and our homes and our histories rise out of. 

The dead are everywhere.  When my father died in Florida many years ago, my brother and I got on plane to go down and prepare his body to bring him home to Michigan.  And I can remember thinking as we saw him laid out on the embalming table of the Myers — or the Anderson Funeral Home in Ft. Myers, Florida, thinking at first, "This is what my father will look like dead," and then, "This is my father dead," and then, "This is maybe what I'll look like when I'm dead," because we dispose of our dead and then become them. And we do not dispose of their parts easily. 

The market, the retail event involved in organ and tissue procurement is something that may have medical consequence but to most families it remains a mystery, tied up, as your Council has rightly put forth, in issues of personhood, not parts.  There's this "just a shell" theory of how we should relate to dead human bodies.  You hear a lot of it from young clergy and old family friends, well-intentioned in-laws, folks who are unsettled by the fresh grief of others.  You hear it when you bring a mother and a father in for the first sight of their dead daughter killed in a car wreck or left out to rot by some mannish violence.  It is proffered as a kind of comfort in the teeth of what is a comfortless situation, consolation to the inconsolable.  Right between the inhale and exhale of the bone-wracking sob such hurts produce, some frightened and well-meaning ignoramus is bound to give out with, "It's okay, it's not her.  That's just a shell." 

I once saw an Episcopalian deacon nearly decked by the swift slap of a mother of a teenager dead of leukemia to whom he had tendered this counsel.  "I'll tell you when it's just a shell," the woman said.  "For now and until I tell you otherwise, she's my daughter."  The woman was asserting the longstanding right of the living to declare the dead, dead.  Just as we declare the living alive through baptisms and lovers in love by nuptials, funerals are the way we close the gap between the death that happens and the death that matters.  It's how we assign meaning to our little remarkable histories.  And the rituals we devise to conduct the living and the beloved and the dead from one status to another have less to do with performance than they do with meaning.  In a world where dysfunction has become the operative adjective, a body that has ceased to work has, it would seem, few useful applications beyond those we are talking about here this morning.  It's dysfunction more manifest than the sexual and familial forms that fill our tabloids and talk shows but a body that doesn't work is, in the early going, the evidence we have of a person who has ceased to be and a person who has ceased to be is as compelling a prospect as it was when the neanderthal first dug holes for his dead and set our species apart from the others.

The bodies of the newly dead are, therefore, not debris or remnant, nor entirely icon or essence.  They are rather changeling, incubates, hatchlings of a new reality that bear our names and dates, our images and likenesses, as surely in the eyes and ears of our children and grandchildren as did words of our birth in the ears of our parents and their parents.  It is wise to treat such new things tenderly, carefully and with honor.

So I encourage the council as you go to work wrestling with these difficult issues, that you consider the traffic between the living and the dead  because in most of these situations, there is no medicine or math, no bottom line or Bible verse, that will explain the mystery that we behold when we behold someone we love dying or dead.  I know this for a fact, not only because of my professional and personal experience, because I sense it in the lives of people all around me. 

Today as we speak, my sons are conducting the funeral of a man who died on Sunday in a car wreck near Milford.   He has a son who is two years old and his wife is pregnant with their second son.  They have decided to name this new thing, this yet to be born son after his dead father.  Before he was brought to the funeral home, an OPO quite properly asked his family, his widow, his newly widowed wife if she would make what is called the gift of life.  She decided yes.  That would assist her.  The notion that he was ongoing there in the intensive care ward.  That he would want that, that he was always full of life and he would want life, such as he knew it, to be given to anybody else who could get it from him. 

So we don't have to wonder the comfort that that wife and family feels in knowing that somebody out of the sadness that has occurred to that family, will be saved or lengthened in their lifespan or returned to their family in a way this man will never be, but those are mysteries.  And when she holds her new son five months hence, named for the dead man he'd be named for, she'll know that mystery.  It's about living and dying and ceasing to be. 

Let me close with one more poem so that you can tell your adult children or teenagers tonight that you, among other things, went to a poetry reading.  It's like being the President of the Rotary Club, you only have to do it once and it goes in your obituary, so (laughter) once you've heard this, you are a raconteur of literary events.  I give it as thanks, in part, for your listening to our conversation.  To have a room full of experts and studious people consider these things, is like going to the shrink and not getting a bill for it, so I'm very grateful.  (Laughter)

A Death, it's called, I mean, it's an occupational hazard for the likes of me.  In the end you want the clean dimensions of it mentioned, to know the thing adverbially while asleep after long illness, tragically in a blaze as you would the word of any local weather where it gathered, when it got here, how it kept the traffic at a standstill, slowed the pace, closed the terminals.

Lineage and issue, names and dates, the facts you gain more confidence in facing, histories and habitats and whereabouts.   Speak of it, if you speak of it at all in parts.  The CVA or insufficiency or growth that grew indifferent to prayer or medication, better a tidy science for a heart that stops than the round and witless horror of someone who on a dry night in perfect humor, ceases measurably to be.  Thank you, God bless.


CHAIRMAN PELLEGRINO:  Thank you very much, Mr. Lynch.  We will proceed —

DR. FOSTER: Mr. Chairman, point of interruption for a second.  I wonder if you would ask that the little poem be printed out for us as a gift for your very gifting speech.

CHAIRMAN PELLEGRINO:  Thank you very much.  We will do as we did this morning and have our second speaker, Dr. Stuart Spicker and then a member of the council will open the discussion of both papers.  Dr. Spicker is Professor Emeritus of Bioethics, Philosophy, at the University of Connecticut.  Stuart?

DR. SPICKER:  That cliche about a hard act to follow, A, it's not an act and it was wonderful that you preceded me because you said so many things, the shortness of time wouldn't even let me introduce, never mind develop.  So out of the blue, we're kindred spirits and we have never met and perhaps, not read much of one another either.  Who would have presumed that?

On May 14th, 1964, I met Dr. Edmund Pellegrino for the first time at the VA Hospital in Lexington, Kentucky.  As coincidence would have it, I turned, oh, dear, 27 that day.  We were both attending the opening session of the Second Lexington Conference on pure and applied phenomenology. I promised I wouldn't use that word much with the Council, which was the second of five Lexington conferences all organized and their proceedings published by Dr. Erwin Strauss, eminent psychiatrist, philosopher and gentleman.  Indeed, the Lexington conferences were the  true birthplace of what later became the trans-disciplinary symposia on philosophy and medicine and the subsequent book series "Philosophy and Medicine," which continues today under the competent authorship and editorship of my close lifetime friend Dr. H. Tristram Engelhardt, Jr. of Rice University, Texas.

Having formally studied in — with Hans Jonas at the New School for Social Research in New York City from 1959 to `62, I came to appreciate the work of one of his disciples, Dr. Leon Kass, whose "Teleology and Darwin's The Origin of Species: Beyond Chance and Necessity?" Do you remember that Leon? (It) was published in the Festschrift honoring the 75th birthday of Hans Jonas in 1978 on May 10th and that became Philosophy and Medicine Number 7, and a joy to do. 

Today, therefore, is not only a personal honor, but also a very special occasion for me, to be reunited with these distinguished two gentlemen and you the other learned members of the President's Council on Bioethics.  I come here as disciple, therefore, having followed the paths first pressed down by my predecessors, principally philosophers and physicians.  I recall, as you students may, and you should, that the philosopher, John Dewey had published a book and that book was titled "Experience and Nature."  He provides there in the opening section, precisely such an image.  As humanity walks the earth everywhere making new paths, nature becomes transformed into experience.  It's a wonderful idea and hence, his metaphysics.  That's what this book is.

Well, today it's time to begin another, though surely shorter, Dr. Pellegrino is in the chair, a shorter walk, this time to transform better to, may I say, incorporate one man's experience, not mine, as patient and research subject during the years leading up to his receiving a heart transplant from a young woman donor.  That is I'm coopting this man, Mr. Ed Linz into the philosophy of medicine as well as philosophy in medicine, that's bioethics, to borrow a distinction made salient by Dr. Pellegrino some  years ago.

I have to apologize to the audience, not to the Council because the paper is not distributed for you to read ahead of time as it was for the Council since it's pretty dense and probably would serve more to embarrass me than to get my ideas across, so we've all agreed, I would not read it and it's readable, I hope and it's only a draft still, nothing ever is finished.  And so it should be online.  I've been promised that as with all the proceedings and transcripts and so on, so if you're interested, it can be read at some later time when the staff is prepared to put that out online.  And I thank you and the staff for all that work.

The title of the presentation I gave is "A Transplant Recipient as Patient and Research Subject," subtitle, "Exploring the Zones of Corporeality Between Leib and Körper."  I purposely used the German words "Leib" and "Körper" because the English, soul sometimes and body, are nothing but misleading, confusion as prevalent all the time and what I'm about to say, I hope will begin to clarify some of this Cartesianism which is still with us in everyday speech.  With respect to my deep respect for American jazz, may I say that my favorite jazz tune is still "Body and Soul," but by the time I'm done, soul will be like "it" in "it is raining."  It will refer to nothing. 

So for the moment, let's do a little slow reading in my case of the German from Nietzche.  I want this quotation right up front today.  I'll translate it only because my German is weak and I must be clear about what I am saying.  Many of you know many languages but the German is important because of Leib and Kopor and the fact that Körper is not used in this quotation from Thus Spach Zarathustra penned by Nietzche or published by Nietzche in 1891. 

In fact, the first part of that work is called "On the Despisers of the Body."  We'll get to that in greater detail.  So it goes like this in German, (Speaks in German).  Translation: "Body am I and soul," thus speaks the child. And why should one not speak like children? But the awakened and knowing say, "Body am I entirely, and nothing else and soul is only a word for something about the body."  At this point, may I say, and this is important, staying with the Germans for the moment, who've given us through Wittgenstein another insight, he defined philosophy as the overcoming of the bewitchment of our intelligence by means of language.  Isn't that wonderful? 

I think of the toolkit.  You build something with it and when it breaks down all you have are the tools that helped you build it.  So we are in a paradoxical situation of finding that we abuse and confuse our intelligence because of the use of language, and we can only save ourselves from that abuse by the use of language in the creation of neologisms and all the rest that goes with using a language. Typical Wittgenstein, but terse and to the point, but signals a tremendous obligation and danger, since only language can help us clarify what we muddle up in intelligence.  It all began with language, even Zoleta Tas Kint (phonetic) even the language especially of the child and we still speak like children, how else can we speak.

Now, just a few words about these words.  Talk about what I saw in the literature some time ago, that famous F word, since it's polite to use that expression.  Well we've got some beautiful four-letter F words, body and mind for example and soul another F word.  We're being forewarned, I think, of what's coming, namely I hope in the remaining time I can talk about three things at once, so to speak without being too confusing.  We have one man who's both a patient for a long time, and he still is, and a research subject. 

Secondly, we have to tiptoe in and out of the philosophy of the body for lack of a better phrase in English and finally, I have a little to say, not very much, about organ transplantation, since Dr. Pellegrino gave me the assignment to, perhaps, mention what I saw as one, perhaps, two but only one issue of bioethics as I see it in the context of organ transplantation if time permits, because that, indeed, is the next session and it would be at least a transition.

So let me proceed with these three general themes coming in and out of them, especially the first two, as I proceed without reading you this paper.  First, this word in English, "subject," is, to say the least, ambiguous.  We use it when we're serious as the center of what it means to be human as the being who's the source of his or her moral choices.  This however, is not quite what became the meaning of the word as we began to use human beings as research subjects.  We kind of threw them under, yes?  That is, we have to look at them, if you're the researcher now from your perspective, how do you see these people you're trying to co-op into with informed consent and the rest to be subjects for your — participants in your study.

I should tell you that due, I think, to political correctness, even at the Hastings Center, the subtitle of IRB, their Journal, changed from "subject" to "participant."  I caught that, I was looking more carefully one day.  And so it's not an accident, the idea being it looks too dehumanized, sounds too dehumanized.  Participant, I'm almost consenting already, it's in the word, but it's hard to talk about this one man, Mr. Linz, who's his own research — well, what is he?  Is he a participant?  Well, he's not in a study.  He's participating in his heart transplant situation and we will see when eventually  you read this, as some of you of course have, you'll see that — I like this expression — this man, lo and behold, this man went through the entire American armamentarium of medicine if it was a medicine cabinet that's in there.  You name it, he had it from the very beginning of the diagnosis to finally that heart transplant of the young lady.  There is nothing virtually that didn't happen, and that will include, as I hope to get to briefly, all kinds of prosthesis, not to mention the drugs.  They have to somehow be incorporated. 

By the way, by the way, this is very, very important.  Allow me, because I can't help it, I'm going to speak like a child, too, and you can catch me every time and you'll be really sharp because I'm going to slip into Cartesian language when I don't intend to, when I reject it, I'm going to do it all the time.  It's that powerful, it takes hold of you.  It's impossible to avoid it.  For example, embody, that doesn't sound like one entity, it sounds to me like two.  Embodiment, a word Dr. Zaner used in his work and so on, embodiment, is that speaking with forked tongue when I talk about soul doesn't refer to anything, but there's only body? But don't think you know what I mean, when I talk about body because I'm going to mean something much broader than what your anatomists mean or certainly your brain surgeons mean or certainly your neuro-scientists mean by "brain" or "body."  In any event, you can feel the worry about language, that's what maybe all we philosophers have to contribute if anything, and Wittgenstein knew it and when we get it straight, we can throw away the ladder because we've clarified how language is constantly bewitching us but you can never let your guard down. 

Now, from subjective and objective and then objective science, that is mathematicize whatever it  is you're working on that comes out of the Galilean tradition as far back as Pythagoras, all of you know the  history of science and quantification.  So we take our move now to the other words.  The term "human body," "physical body," for those who have studied enough Decartes, at least got into the Meditations at least got to read Meditation 1 and 2, you've gone far enough.   That is to say, well, because he's so powerful he'll just overwhelm you and you'll wind up like the rest of us.  Maybe you can avoid it.  It's so powerful and such a genius. 

Let me digress, I'm backing away.  Again, don't confuse Cartesianism with Descartes' philosophy.  The man is not the followers of the man.  This was a very special time.  I looked this up to get the exact date.  Galileo's trial, and you know the tribulations and trial and the recent book, Galileo's Daughters, wonderful book, 1633, the trial, 1633, Descartes' Meditations in another country, he's in France, 1641.  That's not very much time, even then.  So I maintain when Descartes writes in his notebooks, Larvatus Prodeo, "I come forward in a mask," in quick form, ladies and gentlemen, I've always held and still hold and I have people who join me, like La Mettrie he was not being straightforward.  He was disingenuous in the Meditations and Descartes is not a Cartesian.

He does not hold to the strict form of his own res extensa, res cognans distinction but it's fantastic.  However, Princess Elizabeth of Bohemia, it takes a woman to found him out, and not let go and she doesn't let go.  Well, Descartes, how is it possible that these two entirely different substances could possibly come together to make one unified human being if we are both of two totally different substances?  Answer, Galileans are already smart, they know their anatomy, in the pineal gland.  Well, wait a minute Descartes, that's material.  So, I'm back to my first question, sir.  And answer, well, God must intervene there and God intervenes in the pineal gland and that's where you become a unified person until you have some brain pathology and you guys all know the rest.  The rest of that trip is the history of science.

So I just wanted that little interlude.  I didn't want to fail to mention it.  It gives me a little confidence that this ruse that's coming forward as an amass, we've inherited that.  I call that Cartesianism rather that Descartes because I think Descartes knew exactly and precisely what he was, so to speak, putting forward in his historical moment.  Well, then we have the res extensa famous example, I don't have to teach Descartes here to you today to you eminent folks, but he gets pure body out of that.  And that, no matter how a block of wax needed changes, one thing doesn't change, it is the same wax, he says, when melted down and cooled as what we started with. So we've got physical universe, everything, including the human body, okay, that's what that looks like.  And then secondly, of course, his argument in the first Meditations that the mind or soul or psyche exists.  He proves that by his immediate connection to cogitations as he calls them.  Enough of the history of philosophy.

What now has to happen to come forward to the 19th, 20th Century is to see the transition by those eminent psychiatrist philosophers, Binswanger and many, many others we could name and Erwin Straus, namely the Leib-Körper distinction that I already have mentioned and why the German is better than the English, it helps us to do it.  A fast footnote here, Körper is not corpse.  It's not the dead body for autopsy.  We will see it as an extreme condition of still unanimated human.  I'm going to use that word.  And Leib, to give you this other extreme, my favorite example is playing the piano after some years without the sheet music.  You really aren't mistaken to say the body knows how to play the piano if it's the piano.  You call it memorize but the fingers seem to know it too.  There's a strong sense in which the fingers know and the hands know and the whole being knows that work that you're playing.  Or the athletes, since we have always references to sports and other teams, these people are purely fully-lived bodies in their activities of their sport.  They don't think about their illness at the time or whatever they're undergoing.  They are immediately and totally fulfilling and living through the moment and the motion and the self-motility and the uprightness and all the things that go with the current philosophy of the body of those psychiatrists I mentioned.

So what I've tried to say that's different in this paper than my older papers and other older papers, is I think we can distinguish certain and slightly different, I'm calling them zones of coporeality for lack of a better way to put it.  The first is "Leib," the fully lived personal being in action.  The second is "Leib-Körper," a lived thing body. The third is "Körper-Leib" and "Körper-Leib" is sort of what happens, you're experience as you're quite ill.  I find it's almost paradoxical.  I think that's the Cartesian distinction almost, because I don't buy that he bought either.   But that's getting close.  Your body is just the burden, the attachment.  

In fact in asomatoagnosia as you may know this case the psychiatrists often deal with, in asomatoagnosia the doctor has his hand on the table on the patient and the patient says that this arm, the doctor points to the patient's arm says, "That's not my arm, that's yours, doctor," and he means it.  It's not duplicity, fabrication.  It's not lying, it's not self-deception.  It's really this doesn't belong to me, yet it's fully attached.  You know, interesting disturbance and it probably has, it usually always has some neuro-correlate which is something is awry and that's so the specialist, we philosophers don't argue with the scientists with good science and with good neuro-science.  There's no grounds for that.  It's just — it's not the whole story. 

If we could just get these people in this field to understand, I say this.  It sounds like such arrogance, I know, but it just came, you want to shake them up, the Churchlands, with all due respect and the others.  You know the brain and central nervous system are the necessary conditions for certain, perhaps all kinds of experience, but they aren't the sufficient condition to unravel what that experience means.  And I believe members of the Council, I know Dr. Kass has spoken to that, I think, in response I'm trying to tie this back into your meeting with Dr. Churchland at the time, which he did not — as I reread the transcript could not answer the question because the intellectual position on it is just indefensible, but enough of that.

I just wanted to tell you as an aside that this is so stressing and distressing to continue to see all of this going on today in the 20th century.  I was telling Dr. McHugh I have this kind of simple-minded theory, Dr. Pellegrino will remember when he taught this in medicine and he taught that in many other things, when surgery — the surgeon using the hands, these are menial.  No status in that, they are your earth and mud and knife and blood and all the rest, and now brain surgeons get the highest pay in medicine, I think so.  I think they're the highest paid certainly in surgery.  Okay, that's happened.  Is it an accident historical that we are now in a situation where philosophers like Professors Churchland and many others are themselves sort have been totally taken over — have taken over the neuro-science.  They review neuro-scientists' books.  What's happening here?  Is it purely accidental?  How did the kind of brain get back into philosophy?  It's kind of weird question to put it that way because I don't think philosophy is based on brains. 

It's based on brains being a condition for anything human but no more philosophy than walking, that crawling.  Well, in any event, it's for me a fascinating time to see really this rise and the way this has all happened within philosophy and philosophy departments, which it wasn't like that when I began my own studies.  Well, I don't have time to take you through — I wrote here page 17 for the sake of the council members where I do quote the — I do quote Mr. Linz.  Fortunately, Mr. Linz wrote a book about his entire experience and he calls it "Life Row."  Isn't that a great title, trying to stay alive till he got that heart transplanted in him at the very end and he's alive and well, by the way, and lives in Virginia.  And he was a — just for the sake for a moment, out of respect to him, he was a commander at the Rickover of a nuclear submarine and he got out of the Navy, he got enough and he's teaching high school and he was a coach, math teacher, and he's doing okay.  I called him a few weeks ago and said, "I'm going to the President's Council and you're the star, so I want you to know I'm using your name one more time."

He actually corrected this paper for me in places, the one the Council has because there were certain quotations and things about his experience.  Well, they're wonderful.  Maybe I can just — I see I have a few minutes, don't I?  We can go to — the Council and I, at least, can go to page 17.  Just take these, some of it may not be quite right.  I'm still working on this.  It's when he's in Leib mode, Leib zone, okay, he's not an athlete at this point, Leib.  "I feel lousy, not so hot."  The surgeon told Linz, "You won't even know that it's here, there.  It's the ICD," the implanted cardio defibrilators. "My donor's heart is part of me," you get the picture, fully incorporated, living a life, doesn't think about it any more.  Now and then he may, but he's doing what we all do with our hearts up and running as they are. 

This is Leib, now Leib-Körper: "I felt no sensation from the actual high frequency sound waves that were mapping my heart, my heart," do you hear the distancing about his own internal organ?  Let's see, "mapping my heart.  It was never the physical pain, but the immediate fear that my heart would not respond to the shock and I would die immediately."  There's a kind of detachment going on is what I would claim.  Now, Körper-Leib, "The right ventricle of my heart was not working well and both my right atrium and right ventricle were enlarged due to the sarcoidosis that  started all of this, but the sarcoidosis did not spread throughout my body.  I now had two metal encased computer systems inside my body keeping me alive."  I'm calling that a description under Körper-Leib.  Do you see he's getting more Bionic Man-like in the language.  Do you see what I'm driving at?  A show of hands, class.  That's the routine and maybe I didn't say it well.

            And here's Körper, remember it's not corpse, "The doctor" he said, he gets a female doctor, this is great.  "The doctor, she said, might stick fingers in various embarrassing places in my body.  I was repaired by a laptop," he said later.  "I could lift virtually nothing.  Getting up from a chair was always an adventure."  What I'm trying to say there is, I'm taking those as descriptive of being much more thing like than living thing like.  Do you see my drive?  I could be a bit wrong on that last one.  But do you get this picture? 

Here's this male going to a female doctor and you kind of have your eyes closed.  What are you hoping?  I mean, I've been there.  What are you hoping?  Geez, will I not, first of all, get off on this, think of the transcript.  You know, I'm not supposed to get excited from this.  This is just, you know, I've got to objectify this.  I don't know what else to say, right?  She's got to do it, I have to go through it, I want this over with.  I'm going to thingify (sic) myself.  Have we all been there?  Do you know what I mean?  I'm going to thingify myself, hopefully for as short as possible.  And you cannot live in the body.  It's very hard to do but we do it better — that's not the best example, but you know, we can do it.  And I have it in the paper for the Council which I will get to in my time.

I have the Weltanschauung where it's Plotinus and maybe with the time I have, not to — not to fail to mention this, I think I have to now that I've set you all up, I have to find that on page — if someone would help me, the Plotinus, 19, thank you.  I think I almost have it.  Well, 19 and 20, let me find 19.  I hope I can in the time I've got.  Well, if I can't someone else — I've got these pages all mixed up here.  Oh, 19, having said about this detachment, and making — putting aside, okay, putting aside body, okay, just putting it aside, here it comes right from Plotinus himself from the fourth Ennead, the soul's descent into the body and so on.  Listen to this theological experience, not a medical exam.  "Many times it has happened lifted out of the body into myself."  We've got a soul and body here, this is clear dualism, Plato, right? 

"Becoming external to all other things and self-encentered, beholding a marvelous beauty, then more than ever assured of community with the loftiest order.  Enacting the noblest life, acquiring identity with the divine," after all this is third century A.D.  "Stationing within it by having attained that activity, poised above whatever within the intellectual is less than the supreme, yet there comes the moment of descent from intellection to reasoning and after the sojourn in the divine, I ask myself how it happens that I can now be descending and how did the soul ever enter into my body, the soul which even within the body is the high thing it has shown itself to be. Plotinus' account of his soul's assent from and descent into the body reflects not only his disdain for matter," and in our context it's the thing body is limiting case, Körper, "but an ontology or world view that is throughout sternly non-worldly.  Indeed, even the zone of corporeality, Leib, is nothing more for Plotinus than a prison and all the heavenly bodies, the cosmos, nothing more than a denigrated "evil empire." This is pre-President Bush. 

"Everywhere we hear of it, the human soul is in bitter and miserable endurance in body.  A victim of troubles and desires and fears and all forms of evil, the body, its prison or its tomb, the cosmos its cave or cavern."  Furthermore, as matter is absolutely evil, absolute deficiency of good, and vice and body are one, he adds," and I'll close with this, "for weakness in the body is not like that in the soul.  The weakness be in the fallen souls, neither cleanse nor clean and in them the weakness will not be in any privation but in some hostile presence like that of phlegm or bile in the organs of the body. 

"This is the fall of the soul, the entry into matter.  Thence, it's weakness, thus the cause once of the weakness of the soul and of all its evil is matter.  The soul would never have approached matter but that the presence of matter is the occasion of its earth life."  So the human body, its earth life is like dirt or mud, whereas the soul, the high thing, is like a perfect, I hate to say diamond, that's material but you get the idea by metaphor. 

So we have it, I think, but there is another Weltanschauungen that stands this third century Platonism on its head and that's the one where soul, Nietzche and others is just another name for the body, that's not Plutonus, that's not the Cartesians, and may not even be Descartes, if pushed.  It's in Wittgenstein one more time and I don't know if I can find that page, but (speaks German), the human — now that's Wittgenstein using Körper not Leib unfortunately.  The human body is the best picture of the human soul.  Well, that's I think — except for my concluding word, that is all I would have time for today except to signal to you just that one little problem in bioethics that maybe needs consideration when looked at from the point of view of the Council on transplantation, organ transplantation, to be specific.  Let me see if I can locate that. 

But I know the problem so I'll just say it in the few minutes I have left.  And it goes like this: Ed Linz and thousands more if we consider all organ transplantations of all types of organs including intestines which I tend to fail to mention some time and of course, livers and the rest, if we consider all of these organs, these people who receive them are on immuno-suppressants and they're on them forever.  They're very expensive, someone is paying, insurance or the individuals or what have you.  Question or point of fact, they're beginning to organize, these people, and they're making a certain claim.   The American pharmaceutical companies and industry have an obligation to do research and to find ways that we can be taken off these immuno-suppressants, for this reason.  We are far more prone to cancer and infection and early death once again, because the immuno-suppressive drugs, you know the general biochemistry and the pharmacology, because we have been saved and now we have another risk not of the organ rejection but of dying or acquiring and dying of cancer and other infections like, of course, the AIDS patients and so on or people who acquire these diseases. 

So the question I think the Council might consider and I'll give you one answer some people are giving, they say, no, no, this is not the obligation of the pharmaceutical industry.  But maybe it is the obligation of NIH researchers.  I haven't thought this one through myself at this point.  You know, I believe in China and you can check this and we should check it, the staff, if you wouldn't mind.  That's the only thing I'm requesting.  I haven't found it.  You can save someone's life, then you must continue to save it, if it's in jeopardy.  They don't owe you.  You continue to owe them.  It sounds a little like that.  Here are the people who have been saved through the organ transplantations and the immuno-suppressive drugs saying there's a societal obligation to find new ways to take them off these drugs because they're more prone to cancer and other infectious diseases. 

Question, is there such a societal obligation and if so, how do we fulfill it.  Another expansive demand.  Now another answer is, well, let the drug companies get ahold of this who don't make immuno-suppressants, right, and let them compete and put those other guys out of business because they'll find what's cheaper and what will get you off those drugs and these will not have the same side effects and make you — have you in greater danger of acquiring and dying from cancer and other infectious diseases.  I'm just beginning to think about this problem. 

I defer to the Council.  I don't know if you've taken this one up.  I haven't read all your transcripts.  Have you actually dealt with this particular problem?  Okay, well, I thought I would end with just this one concern that's arisen.  I first heard about it some months ago and heard about it again when I spoke to Ed Linz, who is a member of such a group and so I thank you for the time and look forward to the question period as my colleague does.


CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Spicker.  I've asked Dr. Meilaender if he'd be good enough to open up the discussion on both of these papers, Gil?

PROFESSOR MEILAENDER:  Yes, thanks to each of you.  There's an awful lot more in not only what you had to say here but also in the written materials we got from you in advance than I can possibly pull together here.  But I want to make my way toward a question, a separate question for each of you.

Professor Spicker is interested in the lived body, sort of a complicated concept that he has there, that can move through these various zones in which it become progressively more a thing and although it never is corpse as lived body, I mean, the corpse would, in a sense be the limiting case when it would cease to be that and then it would be what Mr. Lynch deals in at that point.  Now, we're interested in thinking about taking organs for transplant from living bodies and also from corpses.  I mean, both of these are done.  And what I'd like to see is whether I can get each of you to help us think from your own particular angle the sorts of things that you've taken up, about that question. 

So for Mr. Lynch, I'd ask you to respond to something like this; you said in your talk and it's a refrain in one of the pieces of yours that we had to read, "ours is the species that keeps track of our dead," that's very nice.  I like that a lot.  You never precisely tell us why and that may be okay.  I don't say that as a criticism at all but what I'm wondering is this; if we — if we begin to manage death in such as way as to make organs more available for transplant, if that becomes the primary structuring — the primary concern that helps us to structure dying, or if we ask families as they are in the process of letting go of a dying loved one to consider consenting to organ donation, or if, perhaps, we even offer them some kind of financial incentive to listen more receptively to our request, are we doing anything that in anyway undermines our ability to be the species that keeps track of our dead or if we're not, say a little bit about why you think we're not?  That would be the question for you. 

And for Professor Spicker, you deal primarily in thinking about these zones of corporeality with the transplant recipient, that's your example of Mr. Linz.  I'd like to get you to think a little bit about the donor.  Although it's sort of complicated on your understanding and I may not even have it fully sorted out, which is okay, though, I think since you said you didn't have it fully figured out either.  You do say that sort of in terms of this process of being sort of pure — in which we experience ourselves as just lived body to increasingly thingafied in some ways that you say that the sicker we are, the more likely we are — you hypothesize, the sicker we are the more likely we are to be willing to think of ourselves in more and more thing-like ways and that on the other hand, the sort of healthier we are, the more we're just pure Leib and little or no Körper, the less we're going to do that.

What I'd be interested in hearing you respond to is whether there's any reason why a healthy person, when I'm experiencing myself as Leib in your strong sense, whether there's any reason that such a person should or should not donate an organ, should, in a sense move into — move into and through that increasingly thingafying process that I think would be required in order to do that.  You know, is there some reason that that would be appropriate for one who is Leib or inappropriate.  I'd like you to think about that.  So from those two perspectives, I'd be interested in listening a little bit to what you say about donation.

CHAIRMAN PELLEGRINO:  Mr. Lynch, please.

MR. LYNCH:  Thank you, Doctor.  I don't see this as an either/or, either we take care of the needs of people in need of organs or we downsize the honors or obsequies done for our dead or the record we keep for them.  I don't think that a concern for the living  needs to be trumped by honors or things done for the dead.  I see this as a constant traffic because as more than a few of us have pointed out, every one who is living is going to be dead and everyone dead was formerly living.  So this is a human condition, not a medical condition, not a retail event, not — it's an existential problem and our culture is, as we might have guessed, at odds in this.  We do things that are — well, for example, we spend a fortune on bringing our dead home, recovering our dead from hurricanes and tsunamis and wars and other acts of God and human nature, and yet, we are part of a species, part of a culture that often times wants to look the other way.  We don't see our dead coming home from war.  We are prevented from it.  We don't watch executions.  We are — I see often times people who constantly are in the market for what they — you know, for a commemorative event at which, you know, the finger food is good, the talk is uplifting, the music is life affirming, someone can be counted on to declare closure, usually just before the merlot runs out, and everyone is welcome but the corpse. 

The corpse has been dispatched, downsized, disappeared by usually someone like me who is called in the middle of the night with a, you know, cell phone and a Gold Card and disappeared.  We live in a culture where in the space of a generation we have gone from two or three percent cremation to 40 — well, 30 or 40 percent cremation and all to the good because we are not, like our grandparents, grounded geographically or parochially to a place.  We are more divided and a bit more scattered.  So cremation suits us.  And yet nobody sees cremation, nobody wants to.

Everybody is in favor of cremation but nobody is in favor of crematories.   We don't like the burning part.  And more and more people will say, for example, speaking of their own deaths, "When I'm dead, just cremate me," and the operative word in that is not "cremate," it's "just."  And the emphasis is on the minimalization of bother and in many ways minimalization of the body in such a context.   The uses of the body become almost entirely a matter of performance, extra parts.  We become, you know, the rag and bone shop of the heart as Yates called it.  We become just the parts.

I think the fully engaged — to take Dr. Spicker's metaphor, the fully engaged species does both.  They respond not only to the apparent need, the manifest need for more donors, but they respond to the — you know, to the human need to keep track of our dead, to give them their due. 

DR. SPICKER:  I'm not sure I have the question clear.  Were you asking me about — first you distinguished corpses and living bodies as the sources of the donation, so we can leave out corpses because I thought you were asking me about the timing.  Was that the force of your question?  That is, what — the zone of corporeality one is in would this effect the timing of when you would more likely get a yes than a no for donation or did I miss your question?

PROFESSOR MEILAENDER:  No, I don't think that's what I was asking.  What I want to know is, is there anything troubling or inappropriate or problematic about a person who is experiencing himself as Leib in your sense, farthest removed from pure body or thing or something like that, is there anything inappropriate about such a person deciding to donate an organ in the process of which he will inevitably have to come to think of himself largely as thing?  Is there any reason we shouldn't do that or is that perfectly compatible with your understanding of these zones?

DR. SPICKER:  Well, I'm glad you — zones, right.  I also tried — I didn't have the time to do what I did in the paper, I was also signaling almost you could jump zones and you could go in the reverse direction.  There was no intrinsically logical order to this business about one zone to another.   I was just trying to give a — let me call it a crude of the patient, the kind of crude phenomenological description through his English account of his various moments in his illness and when he's feeling better, both of those, I was just trying to give sort of what I call idea types of statements to capture and help me see the differences between these different zones.  So there's no logical distinction in a sense, between them. 

So I don't quite see — I think I understand your question better, that you — in consideration that you would be treating yourself as some contributor of part, but this kind of comes back to how I wish to construe this and I think it's something even Leon pointed out in some other context, and I can view — I can become such that I can — and that's the worry we have, that we will, indeed view ourselves as just replaceable — German has Teil and Stuck you know, just the replaceable Stuck are pieces of cake as opposed to integrated where I give you four matches and it's a Gestalt okay.  You can't help but see the square.  You can't help it.  You can't see it as four matches. You can try to cover your — do what you can do.  It's so demanding.  Do you see what I'm getting at?  It's another — it's the way we want to normally see ourselves as a totality.

But we can certainly do all the breakdown and there's even a modern word for going the other way to the gestalt, called emergence.  That's a word that's kind of the opposite of reductionism.  You could also use that word for me and what I'm talking about, reductionism but I avoid it for obvious reasons.  No, I guess my answer to your concern is I'm not so sure — let me put it another way; I think I can by persuasion and the language I use effect the way someone is going to view himself or herself as a donor of a particular organ of their body, whatever that organ is.   Quite different when it's one organ, which you could conceivably spare, certainly not the heart, or where you have two as in the case of the kidney or one where you're going to lose part — or give up part of your liver where there's only one liver.  You can tell a different — Wittgenstein I think would say, you can draw the picture you want to the other two to adopt.  You can — it's like when we get informed consent in the West, we can write that up a certain way.  We could write it up another way and what we're looking for is some understanding of approval of participation and, of course, the legal worry we have about not having such a signed document, all of that.

I don't know if I'm answering this very well.  I'm sorry.  I just see a lot more arbitrariness in this than anything rigorous from what I said.


DR. KASS:  Thank you very much.  I think the theme of this session, at least I would like to think that the theme of this session is absolutely - might seem remote from the questions of organ transplantation.  I would like to think that Council members would share my sense of the primacy of these anthropological reflections before one takes up either the ethical questions or the particular policy proposals.  We get sort of two different approaches to this anthropological question; one from the side of the corpse, the other an argument for renewed — a different understanding of what the living body is and the strong emphasis on the notion of Leib.   And I'm not — my own inclination is somehow to think that it is with the latter that we get the greatest kind of mileage and sort of thinking about what the living human person is, though Mr. Lynch, I was just very deeply moved both by what you've submitted and the way in which you spoke.

So my question is actually really for you.  You say that the dead don't care.  And there's a certain sense in which that is obviously right, yet you say also that the newly dead are somehow changeling and I think you mean that they are somehow changeling for us more than they are in themselves.  And yet, I wonder whether it's — this has some bearing on the question of how we think even about extracting organs from cadavers which is not the heart of the matter for the current discussion. 

I'm not sure I — I want to press you on the suggestion that they cannot be harmed in any way.  There's a certain sense in which they obviously can't be harmed.  They're beyond feeling and so on.  On the other hand, a corpse can be disgraced.  The beginning of the Iliad makes that very clear.  "The wrath of Achilles sent the strong souls of heros to Hades but left themselves to be the delicate feasting of the birds and dogs."

And therefore, I guess the question is, how do we have to think about even the newly dead human body in such a way that we overcome the sense that even the removal of the organs from such a body for wonderful human good isn't somehow a violation?  Because I think we need to sort of deal with those intuitions before we can talk about going further down this road or introducing incentives and I wondered if you'd comment to that.

MR. LYNCH:  Well, thank you for the question because I think it goes to the heart of this matter or to the liver or to the kidney or to the face or whatever else we endeavor to retain and we don't have to go to third — you know, to ancient Greeks for what can be done to bodies.  We can go to the daily news and the current war to find out how abhorrent it is.  We can take a death count but the bodies would be brutalized, beheaded, undone in this way is despicable in a way that is hard for us to articulate although we all sense and you are absolutely right to understand that while the dead don't feel it, the living who are in custody of the dead, either by kinship or by legal responsibility or by neighborliness or by nuptials, whatever it is, the one who is responsible feels custodial about the body and we ought to. 

So I have seen for years as a funeral director in a small town, I have seen how the body changes, how the dead change to the living.  And one of the reasons why wakes and funerals and their cross-cultural variance throughout our history work is because it gives time for the living to take on board what has happened to the dead.  So that you see, for example, on the first day when a family comes into the funeral home to pay their, as we call them, final respects and say their goodbyes or whatever we call that confrontation between the living and the dead, the dead are still often spoken of in the present tense.  They are said to have the wrong hairdo as if it mattered to them.  Or they don't look exactly like themself and the stillness is absolutely unnatural because there is no stillness in life that is anything like the stillness of death.  Anybody who sees dead bodies knows this. 

And a day later or two days later or three days later, when we place that body in a hole in the ground or in a fire, you have to take on board that that body has changed for the living.  It hasn't changed for the dead.  There are some post-mortem changes but they are a matter of boredom to everybody.  But for the living, what has changed is that it has ceased to be, so that you can put this loved thing in the ground or in the fire.  And we have to understand that one of the reasons — I mean, one of the things that the OPOs, if that's what we're going to call them, they have to find some framework in which in the setting, the medical or bioethical setting, that they are giving people the same time to connect those dots so that they can say when it's okay for the organ to be taken, when it's all right, when there's enough death resonant, when the change is sufficient that that difference can be done.   And if we don't take that onboard, I think we do so at our peril and we can keep looking at these low rates of authorizing the donation. 

It is not mystery why few people in this culture witness cremation.  If you're body is burned in Calcutta or Bombay, it is done publicly and ritually and the retort is open 24 hours a day and the fire that lights the body's toe is brought from the home fire by the first born and the whole thing is given a religious and spiritual and cultural surround.  And then the ashes are placed in the river and the geography and metaphors and everything works together.

But here we don't see fire as purifying.  We don't see fire as releasing.  Here we don't — we see fire in the Western World as punitive and wasteful because when you're in trouble with God, you go to hell where you're not freeze-dried, by the way, you burn.  That's what we were brought up with and so people have this problem with fire, which is why everybody wants to be cremated, they just don't want to see a body burn.  But it's the same fire, which is why we don't watch executions.  We're all in favor of whether it's justice or revenge or come-upins, whatever it is, we want it, we just don't want to see it because of the changes we might witness.

But take onboard the fact that for the living in care of a dead body they are already thinking those things, they are already thinking, can they feel it?  They're still worried about can they feel the fire that — that's why they don't go. 

DR. GAZZANIGA:  Follow-up question; your colleagues in the pet cemetery business, do they speak of similar mental reactions?  I'm trying to get to the fundamental mental mechanisms here.  Do they speak of similar kinds of grief and transcendent ideas when they're dog dies and they go through this process?

MR. LYNCH:  I haven't — I don't know much about the pet cemetery business but love hurts, I think it was Bodolu Bryant wrote for Roy Oribison to sing, famously, love hurts.  Who was it that wrote those three items on attachment, separation and loss that we all stopped our doors with in undergraduate school?  If you boil them all down, love hurts is what he was trying to say.  So whether you love your AKC registered pain in the ass Burmese Mountain Dog or your grandmother, or your spouse, love hurts.

CHAIRMAN PELLEGRINO:  Dr. Hurlbut and Dr. Lawler.

DR. HURLBUT: Basically what I want to ask but I want to frame it other words is, which zone are we in when we make a donation or receive a donation and a live donation, but I want to premise it by asking something a little deeper.  You spoke in both your presentation and in your writings in a way that both I felt was clarifying and troubling about this question of the meaning of the word "soul."  Now, I mean, it's clear the word soul is a word really for a mystery, for a sense of significance we have. 

In my own tradition as a Christian, the word soul really means the sense that we come from a benevolent source, that we have an intrinsic dignity and that we have an eternal destiny.  It isn't really an explanation of things, of something so much as it is an affirmation of something and it isn't a thing at all when properly seen in deep theological discourse.  I found it a little bit troubling, the emphasis where the soul is only a word for something about the body unless it is qualified slightly because I would, in another sense, see the body as a word for something about the soul, in the sense that there's some kind of an affirmation missing if you say the soul is only something about the body.  It implies that there's only materiality and there's where the problem with this — you spoke in I think a very interesting way about the transformation from mathematical thought to biological thought.  That's good insight that historically has been — it seems to me now the danger in this territory of transplantation is moving from biological thought to molecular thought where we really are reduced to parts. 

And just one final comment before you tell me which zone we're in, it seems to me that the interesting analogy that might be salutary in this overall reflection on the meaning of transplantation would be to recognize that at least in the case of a live donor, well, in the case of any donor, actually, live or dead, it's essential that we harvest, so to speak or remove the organ and strangely suspend its living nature by cooling it, if we have to transport it.  We kind of take it out of the zone of the living, but we know very well that it's a part that cannot sustain itself without its presence in the whole and so, it's almost as though  you kind of take the organ out of Leib and put it into Körper and then bring it back in Leib, and you — anyway, you get my point.  There's a question here of whether we need to rethink something about what a body really is in relationship to what we've been calling the soul and how transplantation might be re-envisioned as something more in keeping with our sense of these mysteries of the source and significance of our being in a transcended realm.

DR. SPICKER:  Well, I didn't have — I warned over and over again, you see I'm warning myself, not to accept, buy into or use the descriptive account of matter or body that's so prevalent right down to that word you just used, molecular, I think you said. 

DR. HURLBUT: In the sense of molecules aren't warm and they aren't alive.

DR. SPICKER:  Yeah, I understand but I guess what I'm trying to convey is what la Mettrie really understood and he wasn't the best telling of it either.  It has to do with the notion of organization.  He finds — in one place he says, he finds no, we would say contradiction or problem with the thought that matter thinks.  Not Descartes or the Cartesian picture that there's thinking and one sense of being in matter body and another, but there's no problem conceiving of a certain kind of organization of matter that thinks and a certain kind of conceiving of the reorganization of matter that gets buried or then later after it's buried or that gets cremated and fired with or without additional —

The first thing, I mean, this is the center objection that — so to speak, I'm not accusing you of an objection, it's natural.  You can come in here as a philosopher and expect it, especially with theologians in the room.  Right away there's challenges to my way of thinking with others.  It challenges, you know, what must go on, must go on beyond the earthly material life, whatever that former shape is.   If there is something other than that, and you've described that in the beginning of your comments when you said things like eternal and affirmative and so on.

You know, I don't mean to digress but you remind me of the same problem Darwin had.  Isn't it the same thing?  He was such a good man and it's so sad about the impact of his theory on his sister and her strong religious views.  And we have people who accept, of course, or we wouldn't have had this whole debate with creation and getting it out of the science class and so on if we really didn't see there was sound evidence for the Darwinian side of it not a mere theory.  It's just a bad way to put it.

So I see that analogy.  For me it's exactly the same kind of worry.  But the Darwinian position still allows us theos — it allows for divinity in the universe, perhaps not the monotheistic God, perhaps not the gods of the Greeks, but some kind of transcendent, a force in the universe if we can use this word.  You used the word mystery, I use it right back at you.  You know, what's good for the goose is good for the gander.  What we don't know, we have to sometimes respect that we won't know.  But it doesn't force — it just doesn't have the force to compel me to capitulate to anything like the Cartesian position.  It just simply doesn't may more than Darwin had to somehow abandon his view because the theologic expected a lot of problems. 

God was supposed to intervene at different times to produce different species.  He was able to show us it just doesn't make any sense.  It's not necessary.  I mean, it made sense but it wasn't necessary and that, of course, is the heart of the debate with the creationists.  That's really the heart of the debate or discussion.  So I'm not trying to pontificate, an interesting choice of words, not trying to pontificate on this position, just that one needs to be prepared for much better thinking about what we mean by body and that's why I like Leib.  I don't like our English word because it draws us back to this narrow or naive or simplistic view.

I say that that living human runner is Leib and I say that's what there is, and there isn't some cognitive entity, a machine grinding it.  This was Kant's problem.  You know, Kant is genius, he's genius.  In other places he give way to — I've got some great quotes I think in one of the papers, some of you read it, where Kant says if we weren't left and right-sided, if we didn't have asymmetry, we couldn't know where we were with respect to the astronomy, we couldn't tell, east, west, north and south. 

We might get two but we wouldn't get the other two if there wasn't a feeling of difference, he says, left and right.  That's the philosophical anthropology, that's the body, the living body.  Even in Kant, see, Kant — I've just got to say this for a minute but here's that tripod, there's one, see it there, see this little tripod, that's all you are.  This stuff, this — what's that word they used in that movie, pulp, which is — you said it in your talk, we're real simpatico, we're just pulp.  Dig a little hole here, see and just lift out the brain and all the central nervous system and that's Stuart Spicker, see? That's the modern view, that's really what's driving these guys, okay.  That's absolutely crazy.  It's the runner that's who he is.  That's the full runner and right down to his fingertips not just the nerves in the fingertips.

And none of this — this is all getting lost.  If you want to call it the self or the person I'm watching those words, too, because they're fully loaded back into Cartesianism that really worries me deeply, but I'm really worried about the neuro-sciences of the 21st Century, they've really got me crazy.  Okay, they've got me really crazy because they're going to really finish this off, except for our esteemed colleague here.  I thought he was the enemy until I read his book and then I realized, no, we — by the way, what will go down in infamy is his page 101.  It's the one about responsibility.  It has to do with being human, it has nothing to do with brains so to speak.

CHAIRMAN PELLEGRINO:  Excuse me, Dr. Lawler.

PROFESSOR LAWLER:  Everything you just said made me a lot more confused.  I agree with you that we shouldn't think about the body and soul as separate things in some Cartesian way.  I can go along with that.  On the other hand, isn't it true that Mr. Lynch is a very poetic and moving and beautiful writer who is expressing his soul.  That is it's a mystery, that one animal and one animal only is born to die.

DR. SPICKER:  Is what —

PROFESSOR LAWLER:  Is born to die.

DR. SPICKER:  You mean, knows will die.

PROFESSOR LAWLER:  Knows will die and so understands life in terms of death and so forth.  And so has — is moved by and has opinions about the dead and so forth and what's wrong with Darwin is, he has no account of either the importance of a particular human person or why particular human persons think particular human persons are important or something along those lines.  So from this point of view, Mr. Lynch and his great presentation and his great writings, I think is not value neutral on cremation finally because it's a form of modern death denial. 

As TV screens get bigger, cemeteries get smaller and just like with baseball games, we now need to be entertained between innings, cemeteries have to have some other things to attract us besides dead people.  So I think his —

MR LYNCH:  Can I respond to that for just —


MR. LYNCH:  Actually, with regard to cremation I am value neutral and proper disposition is proper disposition, whether you burn, bury, blow out of a cannon, leave it for scavenger birds, I'm indifferent to that.  What I'm interested in is what happens to the — not what happens to the dead guy, once he's disposed of but how the living get him to the brink of that disposition, that's what —

PROFESSOR LAWLER:  So you're value neutral on the literal fact of the burning, which is perfectly reasonable, but you're not value neutral on how we look at cremation.

DR. SPICKER:  How we do it.

PROFESSOR LAWLER:  That's exactly right.  So there would be a way in which it could be done well.

DR. SPICKER:  Yes, yes, done well elsewhere.

PROFESSOR LAWLER:  Right, and there might be something in fact, creepy about open caskets that's unique to us but that's not the subject for today, except to say I sort of agree with you that perhaps we can't harm the dead but it harms us not to be moved by and think about the dead in the proper way.  So it harms us to think in terms of procurement and harvesting and all that with respect to organs but we need not think of organ transplantation that way.  We can think of it in terms of a gift of the person that we remember in terms of the life of someone else and no doubt there are other ennobling ways of thinking about it.  So finally, a lot of our concern of transplantation would be in terms of the way we think about human beings in general now and the scientific ability of transplant being sucked into that.  And so what we have to do is understand our scientific ability to transplant to save lives or to extend lives to be fundamentally a good thing as long as we think about it in the proper way.

CHAIRMAN PELLEGRINO:  Thank you, Peter.  I think we have reached the end of our time so that you'll have a lunch period.  We would be back here at 2:00 o'clock, please.  Thank you both very much, Dr. Lynch and Dr. Spicker.

(Whereupon at 12:43 p.m. a luncheon recess was taken.)


CHAIRMAN PELLEGRINO:  I think we're ready to go.  For those of you who have been good enough to come on time, we will start as close to on-time as possible.  We're still a little bit late.  Can I have some quiet in the back of the room please.  Thank you very much.  I'm glad my voice is carrying there.  Thanks for the power.

This afternoon, we're going to have a discussion of two papers which are in the procedure book.  We'll start by having one member of the Council, our newest member, Professor Schneider, open up the discussion of both of these papers and then we'll spend the rest of the time with the Council making comments or queries as they see fit.  Professor Schneider.

PROFESSOR SCHNEIDER:  Thank you.  I was just looking around.  There is one author and the other author I assume is soon to be here.

CHAIRMAN PELLEGRINO:  He'll be back.  He promised to be beamed down.

PROFESSOR SCHNEIDER:  With a name like Meilaender, I assume he's very prompt ordinarily.


PROFESSOR SCHNEIDER:  There you are.  I'm sorry.

PROFESSOR MEILAENDER:  I just didn't bring my thing along.

PROFESSOR SCHNEIDER:  I kept looking at the empty chair.  I was enormously stimulated by both papers because they were so thoughtful and they made me think and I want to talk very quickly about some of the things that they made me think about and to ask for your help in understanding the papers better.

The first thing that struck me about the papers was how enormously powerful they were rhetorically.  There is language that is mobilized here that seems to be at the outer limits of the serious.  There are phrases like "destroying ourselves in seeking to do good," the possibility of "our being diminished, dehumanized and corrupted" and so on.  And I'm not entirely sure that I understand where problems at that extremity are actually materializing in the debate about transplantation.

As I looked at the arguments, I could see that carried to some possibly imaginable extreme problems like this might be arising, but I couldn't see that they were anywhere near to actually arising.  For example, there was considerable discussion about the consequence of our being embodied and the fear that transplantation somehow endangered the meaning of that.  But it was never possible for me to understand  how the factor bar being embodied in the actual context in which transplantation occurs has actually created any kinds of problems.

To take another example, I agree that death is ultimately not preventable and that you can't try to exert all of your social resources for solving all of the problems that death presents.  But it seems to me that we're a long way from reaching the point at which we would say to people "Well, you're dying; death is inevitable and we need not agitate ourselves about preventing it in this case."

Finally, I'm happy to agree that there are limits on altruism, but it's not clear to me why those limits on altruism are being approached here.  In fact, if I were to try to think about the problems the country has, reaching the limits of altruism does not seem to me to be very high on the list and a situation in which it is possible for the country to agree that altruism is a good thing and to see people practicing it in a fairly dramatic way I think is a socially very desirable sort of thing.

I'm certainly enthusiastic about the idea of looking, as Dr. Kass was saying, at these questions anthropologically.  I think my difficulty is that I don't understand the anthropology in the same way that I think a lot of the people who have been talking so far today do.  My own contact with these issues comes partly from having done research with dialysis patients and partly from familial experience and I guess I see a lot of these kinds of questions in a much more cheerful light.

For example, there was a good deal of concern in the papers about the prospect that people would be coerced into donation.  My reading of the empirical literature suggests that coercion has turned out to be far less of a problem than one might in principle anticipate and there are a lot of reasons for this.  One of them is that when people make decisions about donating organs, they don't think long enough to be coerced.  They tend to make their decisions with such rapidity that they've decided what to do by the time the question has been posed. Informed consent doesn't work with donation of organs because people have already decided one way or the other to donate their organs and the fear of intrafamilial pressure according to the empirical literature that I've looked at also does not suggest that very much of this coercion goes on.  I have to say that if a certain amount of pressure goes on to recognize your obligations to help members of your family, it doesn't unduly concern me a priori.

One more issue along these lines of the facts of the anthropological situation: far from feeling that they've been coerced into doing something, the record suggests to me that people who have donated organs feel that they have benefitted enormously from it, that they very often feel that it's the most important thing that they have done. I'm talking about living donors and the empirical studies of them suggest that they wind up being happier people than the average of the population because of their donation which has changed the way that they think about themselves.

And I do think that it's also worth saying that one reason you might be interested in transplantation, whether it's a crisis or not, and I must say I don't have any idea what the word "crisis" means and I propose not to use it if possible. But one reason you might be in favor of transplantation is because of the evidence that in many kinds of transplantation at least the transplantation is cost effective.  That is, that you get more effective treatment of patients for less money.

So I appreciated the rhetorical and argumentative force of the papers, but I'm still not sure that the papers ever actually go to the point of saying not it is possible to imagine a world in which things have come very badly apart, but in which we are actually in any danger of reaching that point.

CHAIRMAN PELLEGRINO:  Thank you very much.  Eric and Gil, how do you wish to respond?

MR. COHEN:  Thank you very much for the comments.  The most forceful point I take, and let me see if I can respond, is not seeing as clearly as you would have liked perhaps the dilemma that we confront in the current practice of organ transplantation and even more deeply I think the dilemmas we confront as we think about possible reforms and way to try to boost the organ supplies.  Let me see if I can quickly paint a clearer picture of the dilemma than I did perhaps for you in the paper and hoping that Gil will  help me out.

I want to focus on the issue of living donors because I think, to be frank about it, that's where the action is.  We've done a very good job in as much as our goal is to increase the supply of organs with the collaborative that's been going on over the last few years and improving the rate at which we retrieve organs from the deceased who are eligible to be organ donors and there is frankly simply a limit to the number of deceased owners that we'll ever have.  So inasmuch as we face the prospect of hundreds of thousands or even millions of people in end-stage renal failure who are in need of organs and if we think that is a crisis that needs to be ameliorated, the only place we can look to ameliorate that crisis short of finding other alternative medical approaches to it is to living donors.

Even before you begin to think about financial incentives and the issue of commerce, the practice of procuring organs from living donors "test the outer limits" to take a phrase that you began with of the medical ethic.  I think it's a testing of the outer limits that is frankly justified in many situations.  But it is a novel case where the doctor is cutting into a healthy patient and where the person only becomes a patient in the first place because of the action of the doctor.  It's kind of an inversion of the typical encounter between the patient and the doctor.  Usually patients arrive on the scene sick and wants the doctor's hands to help them.  Here the patient arrives on the scene healthy and it's only the doctor's hands that put them into any kind of a jeopardy.

Now in the kidney case, the risks are fairly limited, more severe as I understand it in the liver case, but Dr. Arthur Matas who came and spoke to the staff who is a very accomplished kidney transplant surgeon and also a very articulate defender of the case for having financial incentives with a view to trying to increase the organ supply described the surgery of procuring the kidney from the healthy living donor as the most terrifying surgery he's ever done.  He said it's not the most complicated.  It's not the most technically difficult.  But it's the most terrifying.

Now I think it's in general and in many cases a very good thing that he does this terrifying surgery, but I think it's at our peril that we ignore the fact that we do something a little bit terrifying or something that should terrify us a little bit when we see the healthy as a potential source of rescue for the sick.

When you begin to move to where we are, which is people calling for potentially significant changes in the way we do things - namely, going from a system that is organized around the principle of gifting to a system that is driven to some degree by the financial incentives that might be given to living donors, we simply can't ignore the fact that the sellers are going to be the poor, predominantly.  Most well-off people are not going to sell their organs as a way to buy a third car.  The people who are going to sell their organs are going to do it largely, I think, as a kind of act of desperation.

Now, there's something strange about worrying about the exploitation of those whose situation is already so desperate that in a certain sense they live in a state of exploitation.  But to talk about financial incentives of the poor to sell their organs changes something which now in many cases and hopefully in most cases is a kind of act of magnanimity  - an act as it confers, as you say, great benefits on the donors to an act of desperation.

It's clearly been sort of free market conservatives who have made a rigorous case for the buying and selling of organs, some even saying that this would simply be a way of improve the quality of life of the poor.  But even from a conservative perspective, even from the perspective that takes self-reliance seriously as a virtue that all of us need, but the poor, where it's possible, need especially - one is not self-reliant by selling a piece of one's body.  Right?  The constant critique that everyone profits in some way from the organ transplantation system  except the donors is certainly true and can't be ignored and the commercial dimension of this certainly exists.

But those who are compensated are generally compensated for professing something.  They're compensated as professionals, as doctors, as nurses, as professionals working for the organ procurement organizations.  The donors who might potentially be compensated are not being compensated for any profession they have, but for a part of themselves, a part of themselves that has turned into a piece of alienable property.

So I guess the point of this and I'll close and turn it over to Gil is: we can't ignore the dilemma in the practice as it currently exists.  We can't ignore obviously the great hardship of those who suffer for organs, the great virtue and goodness of the physicians who give them hope, of the family members or generous donors who give them the organs that make  that hope possible and in general, I think organ transplantation including the living donors is better rather than worse.  But we also ought to still be a little terrified at the practice as it currently is and we ought to recognize how much more terrifying it might become if we turn it from an active magnanimity  into an act of desperation.  I think that's really what the heart of the debate at least about the issue of financial incentives turns on.

PROFESSOR MEILAENDER:  Let me add just a couple things and then we can see where you want to go.  The "outer limits of the serious" is exactly what I would encourage you to think harder about, not in the sense of where we might go, but what the inner meaning, the true meaning, of certain events is.

Let me just comment on a couple particular things that you said, but then come back to what I took to be the central thing that I was trying to accomplish which I may have failed to accomplish because it didn't seem to come through very clearly to you.  But I think a slightly more careful look at some of the things I said in my paper would be useful.  For instance, you moved very quickly from saying for someone death is not preventable to hence we need not agitate ourselves over that, whereas I tried to take some care to work through the two angles from which we must always look at death, the one angle from  which  of course it is always an existential, deeply troubling problem, another angle from which that simple fact can't become in and of itself a crisis, so that there wasn't any easy move from the one to the other.  I think the trick is to learn when and where we need to talk in one way and when and where we need to talk in the other.  I'd say that.

The limits of altruism issue is not a question about whether we have so many people performing altruistic acts in our country that we should sort of worry that maybe we need to tamp it down a bit or anything like that.  That wasn't the issue.  The issue is whether there might be some acts which, though altruistic in spirit, nevertheless undermine the integrity of the body, the lived self in the body.  That's the issue.  It's not a question about whether there's a large percentage of altruistic people around in our society or anything like that.  So that's the issue and I think once again your way of reading it missed the kind of question that I was concerned about.

And that would bring me back then to what  I thought at any rate I was fundamentally trying to do  which I think does make contact with what people are currently talking about and arguing about in connection with transplantation and that is: I was trying to understand why one might turn in the direction of gift rather than commerce and why in fact we have in the past turned in that direction because the pressure to turn in a more market direction is a recurring pressure and it's a fairly strong pressure right now.

That's what I was trying to understand and I don't think it will be sufficient just to say this is what we've done, here is how we've done it in the past, here are what some authorities say.  I wanted to try to understand why it is that thinking in terms of gift might retain a certain sense of the organ.  It's not just a sort of part or a thing, but the self that is given there and why that's lost in some ways if we think in terms of commerce.  That doesn't seem to me to be out of touch with where discussions are going with respect to transplantation.  On the contrary, it seems to be right at the heart of one central point.

Now I may have done a lousy job of trying to do that.  That's all possible, but that seemed to me to be the chief point that I was trying to get at and to be honest to suggest that that's not at the nub of some important issues in transplantation right now, I would really find that astonishing.  I just don't believe that.  I think that would be mistaken.  So my apologies for not getting it clear, but that's the point and it seems to me that that's a point which unless we think through and try to understand we really won't be a position to say much that's useful about the commerce issue.

PROFESSOR SCHNEIDER:  If I may ask one question, I did not understand either paper to be about the specific question of selling organs.  I understood it to be much more directly about the very idea of transplantation itself.  Did I misunderstand that?

PROFESSOR MEILAENDER:  Yes, but there's an important — No, you did not misunderstand what the paper was about in one way, but there's an important part where having talked a little bit about what Richard Epstein had to say at our last meeting.  I note from something that he wrote elsewhere that he points out that the strongest arguments against turning the organ, it wouldn't be organ donation anymore, but the organ donation process into some kind of market system  are arguments that in fact might be taken to be arguments against transplantation more generally and that therefore that's why I turn to thinking through transplantation more generally and trying to think through the way in which the idea of gift is at the heart of preserving some sense of the self that's at work there in a way that it wouldn't be preserved if we turned in the direction that Epstein was recommending.  So, yes, I turn to a discussion of transplantation more generally, but out of that particular concern.

PROFESSOR SCHNEIDER:  Out of the concern about the effect of turning this into a market?

PROFESSOR MEILAENDER:  Out of the sense that you can't answer why you shouldn't turn it into a market without asking some more basic questions than just that.

PROFESSOR SCHNEIDER:  Let me just say one other thing.  It's not at all clear to me that compensating people for, and this is to respond to what Eric said, that compensating people for organs means that you're getting organs sold by poor people.  I realize that's the way it works in India.  But as I've been looking at some of the literature on the difficulties that donors face, the difficulties they face are often economic difficulties.  They're the difficulties that arise out of not being able to work for whatever time it takes them, sometimes a fairly large amount of time, to recover from the surgery and I take it that one of the possible responses is to say we're not paying you for your organ, but we are trying to keep you from suffering economically for the gift that you've given.

MR. COHEN:  I think that that's an important distinction to keep in mind between ensuring that those who want to give as a generous act don't incur insurmountable economic burdens in giving the generous gift.  That's different from paying people a price for their organ as a way for them to benefit themselves economically.  I think that's a distinction that can be preserved and I think they have different meanings.

CHAIRMAN PELLEGRINO:  Other comments?  Questions from the Council?  I have two people, Peter and Bill.

PROFESSOR LAWLER:  I agree that buying and selling is where the action is and I agree that buying and selling is a terrible idea and you don't have to get way metaphysical in order to reach that conclusion.  It's — I guess I can't see how it could be done without avoiding horrible abuse.  To give a dumb and flip example, our country has lots of undocumented aliens and states are electing to give them welfare.  You can imagine a scenario where someone would say "Welfare?  You've still got two kidneys!"  There would be the expectation that your kidney might be understood as part of your net wealth or something.

But having said that, Gil's paper in particular, I agree with you, does seem to be an argument that causes us to reflect upon all transplantation and maybe collapses one distinction I would want to preserve.  He says on page 14 that especially with reference to the footnote that criticizes a great thinker that if I give my dead kidney, my cadaver kidney, in advance I'm giving a gift of my very person as if I can't separate my dead kidney from my being.  It's a tough question whether I can separate my live kidney from my being, but my dead kidney is not me.  So in a certain sense, one of the smallest gift I will ever give in my life will be my dead kidney because it's of no use to me.

So we were talking at length in a certain way I'd be more generous if I'd bought you dessert than donated my dead kidney.  Although when I read this, Gil's reflections, I think a donation of a live kidney has to be an act of love and nothing short of an act of love.  I don't think I would do it otherwise.  So I might step up to the plate like the speaker said this morning for one of my own relatives, but in general, I don't think I would do it because I think it's a powerful argument that it is a gift of my very being.  My dead kidney, I want someone to tell me what's the big deal.


DR. HURLBUT: The issue that keeps coming back to me was brought up this morning by Leon in the sense that there's the word "crisis" and "shortage" that should be introduced into this equation and it relates in a special way that a personal element of what is involved in donation.

I mean I think you bring it out, but maybe you could say more about this.  The idea that there's a shortage or a crisis, it seems to me those are the wrong words.  It seems to me it should be presented as more an extraordinary new possibility or an opportunity to engage a new relationship between healthy individuals and those who are in need of cure.  And to me, that implies the difference between the word "opportunity" and "obligation" and as soon as you start saying there's a shortage or a crisis, there's a kind of obligation that seems to violate the very source power of the goodness of this that is the actual lack of an obligation but the act of super abrogation that's implied in donation.

It engages a different part of the person and in that sense, it carries a certain beauty, truth and coherence of what we see a person to be.  As soon as we start walking the world feeling guilty because we haven't donated, I think we're going to weight down natural life with a new sense of obligation that would not be good.  But if we don't do that we could still lift up that notion that there's an opportunity for a free act of genuine giving and that seems to me not to use a bad pun but the heart and the soul of this whole matter that there is an engagement of the best of a person in this somewhat unnatural process.

PROFESSOR MEILAENDER: I didn't know if you wanted us to respond at all.


PROFESSOR MEILAENDER: Okay.  Just a quick comment.  First, a quick comment to Peter Lawler.  Again, you said my dead kidney is not me.  How can a man who sat here and listened to Tom Lynch this morning say that quite so straightforwardly?  I mean obviously in some senses it's not, but there are other senses in which it seems to me you ought not quite say that.  Then, Bill —

PROFESSOR LAWLER:  Could I ask what they are?


PROFESSOR LAWLER:  Could I ask what those senses are?

PROFESSOR MEILAENDER: Yeah.  They want that kidney from you while you're a changeling in the eyes of your loved ones and it is some sense therefore you that they want.

PROFESSOR LAWLER:   But they don't want, in some alien sense, that they're coming after my kidneys.

PROFESSOR MEILAENDER:   No, I don't think I said that.

PROFESSOR LAWLER:  No, but I have given this thing.

PROFESSOR MEILAENDER:  Yes, I understand that and I didn't say that you shouldn't.  I just was uncomfortable with the — Well, I was originally uncomfortable as you know with your sovereign authority language with respect to it.  But in general, I would just want to be careful and cautious about disassociating one's self too much from those remains.

But then I was just going to say, Bill, I  think I agree with the direction you're going, though worry that I had in the paper was that on the one hand medical progress makes possible something's that remarkable for people.  Then because it has done that, we begin to think of it as a kind of entitlement that we ought to have and then it's a crisis if we can't have it and the use of that language, the reason, I mean there may be a lot of reasons, the reason I back off from the crisis language is that I just think that that language encourages us to do things, at least to think about doing things, that we would not think about otherwise, tinkering with definitions of brain death in order to get what we want, seeing the death of patients becoming, as I said in the paper, a technicality that we need to see to in order to get there, restructuring death in ways that seems less than humane.  Maybe any or all of these are okay.  I'm happy to argue about any of them, but I think that that language that turns it into an obligation begins to encourage all those things in ways that I think one ought to at least worry about.


DR. ROWLEY:  I have three questions and comments.  The first is a whole lot of this involves insurance and health insurance in one way or another. And as has been commented on this morning, it was clear that the poor and, if you will, the minorities of various sorts and the financially disadvantaged are the ones that are, I'm not saying this correctly, but are disproportionately on the waiting list and the people who can afford to take care of themselves are amongst the advantaged and less constrained by what they have to do and the kinds of problems that they face.  So I think we have to be straightforward in understanding that the lack of universal health insurance in this country complicates the whole situation enormously and I don't think we've faced that issue very carefully.

And the third, not the second, issue that I have is with Dr. Pellegrino and just where are we going with this discussion of transplantation because I remember being part of the Council under Dr. Kass and I think it was in 2003, but I can't be confident about the timing, but we did have a discussion about transplantation.  So you may not be prepared to answer and I understand that, but I think that as a Council member I wonder about that.

And the specific question I have for Dr. Cohen particularly because in his paper he refers to the IOM report is the IOM was mainly concerned with organs from deceased individuals and as I recall just a chapter and I realize we're going to have a report this afternoon from the Chairman of the committee that wrote the IOM report, but the IOM report is mainly about organ donation from deceased individuals and, Eric, you made the statement just now that the only place to procure additional donors of kidneys is from the living and I think the IOM report mainly focused on how we could improve donations, if you will, of kidneys from the deceased.  So they seem to be in direct conflict.  So I wonder if you would clarify your statement as to why you think that the only way to increase organs, kidneys, to be specific is from the living rather than from the deceased.

MR. COHEN:   Let me see if I can be clearer than I was before.  I don't think there's no room to procure more organs from the deceased.  I do think we probably can by improving the procedures, by considering some of the recommendations in the IOM report which we'll obviously hear more about later today.  We might be able to increase the number of organs available from the deceased.  The point I was trying to make is that I think we're already, different people have different numbers, but over 50 percent is what's called a conversion rate which is the number of eligible deceased donors whose organs we actually procure.

Now presumably there is going to be some portion of people for their own reasons, perhaps good, perhaps not good, who actually have substantive reasons why they don't want to be donors which means, while there's room for improvement, there's limited room for improvement and there's a limitation that is grounded in how people die which makes them eligible or not eligible to be donors.  So when we take that fact and then juxtapose it with the numbers we saw this morning about the size of the population that has or might have or will have end stage renal disease, the point I was trying to make is that inasmuch as we see this as a crisis that needs to be ameliorated the only way we'll ameliorate the crisis is to not only try to increase the organs we can get from deceased donors.

But to try to increase significantly the organs available from living donors and that's an area where there isn't as much of an inherent limit because any healthy person in theory could donate a kidney.  We're talking only in the kidney case and to some degree in the liver case.  So I didn't mean to suggest that there's no room to get more organs from deceased donors, but I think the real debate that we're going to confront, not the most important debate ethically, but the biggest practical debate, is going to be about policies regarding living donors.

DR. KASS:   Excuse me.  I wanted to speak primarily to Gil's paper and begin with my praise for the form of it and the shape of the argumentation leaving aside some of the details.  First to say, I think Gil is absolutely right that this Council at least ought not to — The discussions that we're having, Janet, may very well be triggered by the fact that even in the three years since we first talked about it, the "shortage of organs and the need to do something about it" has become really a much more lively topic.  There are articles about it in lots of places.  The passion that was generated by this discussion that we had at the last meeting indicated this seems to be a problem that you would have to be an ostrich with your head in the sand to ignore these days.

Nevertheless, if this Council wants to do its job, I think Gil is right in saying that we might take that as the point of departure for our reflections, but we have to step back and begin to think about the human significance of what these innovations produce so that the place that he would like us to begin is not to simply begin in the middle of the things taking the shortage for granted and its place, but to begin prior in an earlier place. And he tries to do that for us by thinking, to begin with, about the limits of how we think about mortality as such.  Carl Schneider's qualification, I think, Gil would probably accept and then to encourage us to think about the strangeness of having started down this road in the first place of what it really means to start to look upon the embodied whole which is our life as also a source of resources in part to benefit other people and the reluctance to start by thinking about the living body as such a resource naturally to go in the direction of the cadaver.

And there I think he does well, forgive me if I'm simply rehearsing what strikes me as the important parts of this, reminds us that in the first instance the dead body is not rightly seen if it's seen only as a natural resource for the benefit of others, but is the mortal remains with which the family and associates have to deal and that in all kinds of ways even if you can't harm the dead person, there is at least and especially in this limited period of what Bill May beautifully called "the newly dead," I don't know whether we've all read that article or not but it should be out amongst us for rereading, that this all too much resembles the person  whose life this once was for us to abstract from those considerations and say "Ah, here is a kidney to save Patient X down the road."

How have we managed to get ourselves to the point where we've, as a culture, accepted this practice overcoming certain kinds of scruples and reluctances?  Gil gives a kind of an account that we've done so not because we think natural resources in the absence of objections we will harvest them or collect them, but we've done so because we see that there is the possibility of gifting, even under these circumstances. And that the giving of the organ is in a way a gift of oneself even when one is no longer here to present that gift and I think it's terribly important when we think about the new proposals to remember why it was we've adopted the practice of giving as opposed to the practice of routine salvage, which is what the French and the other Europeans tried.

Now faced with a kind of critique of this practice because these moral scruples seem to be the major obstacle to finding the necessary organs to shorten the list, there is I think a great deal of pressure to encourage living donation and since living donations are odd, I mean for a loved one it's easy but how to get more people to come forward, that's where it seems to me where the major push of the financial incentives is today.  They're modest proposals for funeral expenses and things of that sort to try to increase donation from the deceased, but in public meetings and in publications, we will hear from Dr. Hippen I think later today, more and more people are thinking that the only way you're really going to address this shortage is to begin really to offer financial incentives and even a market in organs.

I guess I'm inclined to say that unless we go through a kind of an analysis of the sort that's here and see if we can either defend or find fault with the justification for the system which has been in place from the beginning of transplantation and codified in the 1984 Act, we will not be in a position  to justify or think clearly about these new proposals which begin not with anthropology or not with these larger questions but begin with the simple fact people are dying on the list.  What are we going to do about it?

So I would like very much to endorse the paper.  I have some minor difficulties with this or that, but as a form for us to think about this question, I think this is the right shape and I guess my invitation, Mr. Chairman, would be to my colleagues not so much to Gil whose paper this is.  Are there weaknesses in the development of this argument which seem to me to be primarily a justification of the practice we now have made with some fear and trembling and worrying about that there are too many potential transplant surgeons hovering over the family close to the time of death and all of that.  He worries about those things, but he's not asking us to go back on that.  But are there difficulties with the form of the argumentation and in particular with the substance of it?  But that would be my encouragement to my colleagues to see whether he hasn't provided us with at least the beginning of a framework with which to stand before the new proposals one way or the other.


DR. KASS: Sorry to be so long-winded.

CHAIRMAN PELLEGRINO:  Any further comment on Dr. Rowley's question?  To me which I think depends very much on what the Council thinks about the question mark at the present moment, as Leon has pointed out, you've started a lengthy discussion, a good discussion.  As we look back at the record, it's kind of unfinished business in view of the fact so much has happened since the things you've just emphasized.

So the question really is is there something that we can contribute of a positive nature that has not been approached and that's the question before us and the reason for the papers for the rest of the program after which I think we'll take a fresh look at it and try to give you a more specific answer.  But I think I'd like to hear what the Council members feel about this.  It is a very urgent, ethical and social problem and it's going in directions Leon has  very capably and eloquently outlined that will change the atmosphere and I think I would like to know how more of you feel about it and I think the two papers we've had were meant to be a stimulus to you to see in what direction perhaps we ought to go.  One has one's own ideas, but I'd like to hear yours.

I want to emphasize our doing that this afternoon and the rest of today if we can because we look forward to the summer if we're going to make this a major project to trying to get it in its final form so that in the fall you can have something very concrete to look at or we may not undertake it if we decide that after we hear the internal medicine report  or something that there isn't anything significant that we can add.  I happen to think there is, but I'd like to open it up to your comments, Members of the Council.

PROFESSOR LAWLER:  I agree with the general —

DR. KASS:   And excuse me.  I just want to be sure I get both of you.


DR. KASS:  Go head, Peter.

PROFESSOR LAWLER:   I agree with the general sentiment expressed by Leon and Gil that the  metaphor of the crisis produces the thought that there needs to be an immediate response, decisive action, executive action.  But when you think about it, this is a crisis if it is a crisis specific to a very definite stage of medical technology.  Not so long ago, we couldn't do transplants and presumably, and I'm no expert on this, somewhere not that far down the line, we will no longer need to do transplants because we'll have xenotransplantation, some kind of regenerative medicine, artificial kidneys and things I'm not capable of even imagining, but will surely be there.

And so the danger is in crossing boundaries now that would apply to other areas reacting to a crisis is relatively, although real, it's a real problem of people who will die because of end stage renal failure and the inadequacy of dialysis and all that, but there is the danger in over reaction  without sufficient reflection and we may be the guys to do the reflecting on that.  For example, a rough parallel is an issue of euthanasia.  The two arguments for euthanasia that were nontrivial would be tremendous depression and horrible physical pain.  We can now deal with the depression and the physical pain and the same way to cross the boundary and enter into the buying and selling of body parts in response to this alleged crisis I think in the long term we would regret because of this uncertain applicability  down the road and the inability of preventing abuse and all that.

I think you can reach those conclusions with some reflection, with deep reflection, and the character of embodiment and all that, but there's a lot of good common sense that falls short of deep reflection which is also in Gil's paper.  So I agree with Leon that this is something we are well equipped to take up and we should take it up.


DR. BLOOM:  Unless there was some a priori decision that you all made to look at this focused issue, I would want us to take a broader look because it seems to me that while there is certainly a shortage of organs to transplant than there is to people who have end stage renal disease, if we only look at that piece of the puzzle, there is always going to be a shortage and it seems to me we have to look at the causative upstream events that we should speak out about with equal vigor which is obesity, Type II diabetes and secondarily renal disease which are items of self-responsibility.  These people got themselves into this problem.  Maybe they had genetic vulnerabilities that got them further down the path than others facing the same metabolic and environmental circumstances might have.

But if we only patchwork this issue without taking a look at the bigger issue of what causes them to start down this road to disease and even broader issues than that in terms of, to me, self responsibility for your own health, is a major thing that we should speak to because it's unethical for us to pretend that medicine is going to solve all bodily ills and we have to start to convince people or it's always going to be 20 plus years down the road before preventive medicine pays its due bills on this society.  If we learn anything from the genome in terms of vulnerability factors, it's not going to eliminate self responsibility and there's not going to be always a magic pill or a magic organ or a magic cell that's going to make somebody well again after a life of abuse.  So in response to Leon's comment about the form of Gil's paper, I would see an equal stream be devoted to the upstream events for which this is a partial solution downstream.

CHAIRMAN PELLEGRINO:   Thank you very much.  That's very helpful.  Other Members of the Council?  Alphonso?

DR. GÓMEZ-LOBO:   I want to back up a little bit again, but in another sense, not in the medical sense as Dr. Bloom wants to.  Many of these issues were completely new to me in many ways.  So I'm trying to think through the arguments and the reasoning behind them.  Now I think that the Council has helped me a lot in this discussion of the crisis language because surely it's one thing to say there's  a crisis and we should do anything to solve it and a different thing to say there's a shortage here which may be caused by other reasons, but on the other hand, that may not generate entitlements or rights, the kind of thing that Bill was pointing to. So I found it very useful to tackle these problems from a broader perspective.

Now what have I gained from this discussion right now?  At least the following.  The death of people on the waiting list is of course deeply painful to me, but equally worrisome is the cutting through the healthy body as Eric has pointed to.  So it seems that the altruistic motive at the moment is the only thing really morally holding the practice in place and that's why it seems to me that that should be a matter of further reflection because that's exactly where the big differences are going to arise when we get to the issue of buying and selling of organs because I think that's where the pressure is going to go.

Now as a minor contribution in that regard and I'm probably jumping ahead of what Jim Childress and Dr. Hippen are going to be saying I think the question of the freedom of an agent who doesn't have resources and therefore sells a part of the body as a form of income that there is also a crucial issue.  Is there the alleged freedom in that transaction or not?  Because of course, that impinges on the American ideal of autonomy and of course if autonomy is assumed in that case, we may have a justification for the free markets or the regulated markets that would not exist if we questioned that assumption.

CHAIRMAN PELLEGRINO:  Thank you very much.  Other comments on this subject?  Dan?

DR. FOSTER:   I just want to make one clarification about I've heard all morning people talking about doctors cutting on living bodies that are not ill.  I think that most people in the room might have forgotten that we have a huge occupation of doing that right now in plastic and reconstructive surgery.  We cut into these bodies all the time.  We do liposuction and all of these things in normal healthy people and many times with great risk and we don't have — I mean there have been a lot of deaths here and so forth.  So we shouldn't try to set out that there's something magical about cutting into a living body when we're doing that all the time now and it's one of the fastest growing things.

One of the things that was said this morning is the most lucrative salaries in medicine are not neurosurgeons.  They are plastic surgeons and they're paid in cash and I'm talking about the fact that there are huge amounts of money there.  So I just want to clarify here that that is not a valid argument about saying that we shouldn't do this.


DR. KASS:   You're not using that as an endorsement I trust.


DR. KASS:   Thank you.

DR. FOSTER:   I'm not endorsing.


DR. GAZZANIGA:   Yes, just a point of information and maybe the staff can dig this out, but we've heard about how various European countries handle this problem differently by almost conscription by the Dutch by the assumption the state owns the body and so forth and we also have a number of those countries that have basically one payer socialized medicine.  Can we look at their organ transplantation numbers just as an experiment to see whether the things we're puzzling here in fact move to solve the problem?  There must be data on that.  I don't know it.

MR. COHEN: I certainly don't have it at my fingertips the data on other countries, although I think this would be a very beneficial thing for the Council to hear an expert come and talk about.  Obviously different countries have different systems, some with a kind of conscription system.  Iran has some system of regulated payment in fact.  So I think it would certainly be very important for the Council to hear either through a staff paper or an invitation of an expert how things are working in other countries.

Could I respond quickly to Dr. Foster whose comment I've very grateful about?  One has to begin with an important distinction between plastic surgeons who are trying to restore a body that has been disfigured in some way, work that I think is heroic, and plastic surgeons who are being paid in cash to perform changes on the body that are optional at best.  It seems to me that should only further awaken us to the problem here.  I mean the fact that doctors are doing this doesn't mean it's a good thing for us to do.

Now I think certainly in the case of kidney donation and certainly in the case where the living donor is doing this as an act of love to a family member, one in a certain sense could praise the courage of the doctor who is performing such a terrifying surgery precisely because he knows the life of a healthy person in certain sense is in his hands.  But I don't think we can ignore that there is something that should give us pause here and that there's a reason why, as I cited Dr. Matas before, doctors see these surgeries that are not the most technically difficult as the most terrifying and this is not saying that we ought not be performing them, but it does invite us to think about the different human meaning of that surgery and how that meaning might be changed even further if the person upon whom the surgery is being conducted is doing it for pay as opposed to as an act of love or as an act of magnanimity.


DR. FOSTER:   I want to make one other caution.  I think one, Eric, ought to be very careful about the big point you made of an expert that came to talk to you and said this was terrifying surgery.  I would say that if you looked at 1,000 transplant surgeons that you would be very lucky to find five that felt the same way, I mean, in the sense that every surgery is at risk. 

But I was astonished to hear that this was terrifying surgery.  I guess what you meant was that because this was a person who didn't have to have surgery and I suppose that's why that was there.  But I know the person who is the most involved in living liver transplants out in Dallas and so forth and so on and I don't get any sense that this, they want to be very careful about this and so forth.

But I wouldn't want to put too much statement in one person's feeling about doing this, surgeons.  I mean we think we always talk about evidence-based medicine.  If we're going to quote something that is meaningful, then we ought to have evidence for it rather than a singular statement by one transplant surgeon.  Okay?  I mean if we're going to be a serious council we need to look into that as well is the only point, the only response, I want to make.

MR. COHEN:   I'll respond only quickly.  I'm not trying to use this one surgeon's remark as a way to have you see how every surgeon thinks about this.  I will simply repeat that the human meaning of a surgeon performing surgery on a patient for whom the surgeon can do no good for that person's body, he can  only do harm, and especially in the liver case, there's a fairly high rate of complication, not serious complications, and again I'm not saying that the surgeon isn't doing something heroic by performing the surgery.

But I think we need to be at least willing to think about the fact that we have a different kind of encounter here between a patient and a doctor; when someone arrives not as a patient but becomes a patient because of the doctor's action.  I'm not suggesting that doctors are terrified because they're worried about their competence and that was precisely the point I was trying, perhaps failing to make which is that the point here is that the greater pause is not because the surgery is technically more difficult but because the meaning of the encounter between the surgeon and that patient is different and I'm simply  trying to make note of that.

DR. FOSTER: Gil, as long as I have this microphone for one second, I mean to get back to what has been approached here, we have a pretty straightforward problem.  Now if you're worried that taking an organ out somehow diminishes human dignity as I think probably Gil thinks even from the dead, then that's not going to address the problem here.  We take organs out of people all the time and spleens and everything else.  We don't think they're demeaned or it's undignified.  We do it for health and so forth but there's not something magical in my view for doing it.

The problem is a very simple one.  That is we have a lot of people whose lives we can save and save money if we transplant and that number of people is increasing very dramatically and we may be able to increase 50 percent in deceased donor things with incentives of one side or the other.  Our first speaker this morning said that she preferred to do that first of that.  So I don't know how and Dr. Hippen is probably going to tell us that in some advanced hospitals, he told me this this morning, that the conversion rate is as high as 70 percent with some things.  But over all, we could probably double the number of kidneys which are there.

Then we have to ask ourselves the problem, I don't want to sound, the philosophers, Robby George is not here, saying I'm being utilitarian and so forth.  We have to decide is the loss of these people who could be saved such that we take the risk of doing living donor transplants and that has to do with the percentage risk that's there statistically.  If you get in a car, you're going to have much more chance of dying from within a few blocks of your house than you are from doing the surgery.

Now it sounds like I'm speaking for this.  I'm not.  I'm not at all sure that I think that we ought to expand this.  That's what I'm trying to understand, but that's the problem and I think it's maybe one thing to go back and look to say what it means to be a human or what a dead body is.

But I'm interested in the practical problem that we have 93,000 people that are on the waiting list.  Some of them are dying.  Can we do anything about it or do we simply say as a society that's tough luck that that's their problem that we can do that?  And that's what I think we ought to focus on and we may say we don't think that we should do that or we could say that we think the risk is minimal enough that an informed patient might be willing to do that along those lines.

I'm not against these discussions.  I always enjoy reading Gil's papers.  I mean they always make me think even when I don't agree with them.  But that's where to get down to the core, Mr. Chairman, that I think that we can really say something about it.  Now that doesn't mean that we can't couple that with philosophical discussions along the lines we did with enhancement and other things, but it's the practical final answer that we have to - I think that people want to hear from us as a thoughtful group.

PROFESSOR MEILAENDER:   If I could just make two quick comments sort of intervening in the exchange you and Eric have had.  One, I do not believe you're just interested in practical questions at all, Dan.  You're interested in what it means if a human being suffers and what our obligations are to those who suffer and how we ought to think about them and so forth.  These are by no means only practical questions and I just want to — Don't shortchange what you yourself are interested in.

The other is with respect to the business about a doctor finding doing the transplant surgery a terrifying thing in a way.  I would like to put the point normatively.  I haven't made any studies about whether a 1,000 transplant surgeons do or do not feel that way but they'd better.  They should and if they don't feel that way about it, then we need to ask ourselves what's gone wrong, what have we lost that they've lost all sense of the trepidation they ought to have in simply cutting into a living body in order to help another one.

I don't mean that it's wrong to do that necessarily, but I think we can only understand what's going on if we have a certain kind of sense of something very peculiar there and it's very peculiar for medicine.  That's all.  That's a normative claim.  I have no surveys to back it up but they ought to think that way.

DR. FOSTER:   Last thing.  I do want to say one other thing before this conference is over, but in one sense I couldn't agree with you more about both things you've said.  Of course, I'm interested in a lot of other things besides the practical problem, but right now, the practical problem is before us.

But a terrified surgeon or a terrified internist is not a good doctor.  If you're terrified, then you don't make the right decisions.  You want somebody who's concerned about the thing, but if you're shaking about the implications, I think that the guy ought to be worried about how he's taking out the kidney rather than worrying about the implications along these lines.  I talked about the Dallas Mavericks.  They worried so much about what was happening to them that they couldn't shoot shots and that's all I'm trying to say.

PROFESSOR MEILAENDER:   But he shouldn't — Of course, you're right.  We don't want his hand trembling while he's cutting, but we also don't want him to come to think of what he does as such a matter-of-fact thing that important and deep questions about it can no longer be raised.

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

DR. HURLBUT:   I was just going to make a very obvious comment, but since you just made that comment, I would like to add that your comment about the plastic surgery does raise, it doesn't just argue for the similarity here on the positive sense of transplantation surgery, but it argues for the strangeness of quite a few things we're doing in medicine today and I think we're all a little, as a physician I'm a little, uneasy about the trend toward plastic surgery and I think we should reflect on that as the larger arena of the way we're disposed toward thinking about the body.

Now even as I agree with the central point you were making, there is something a little strange when you read an account of somebody who had plastic surgery and then died.  You feel like why did they do that.  There's something about the natural body that remember Galen said, "The physician is only nature's assistant."

It seems to me that you have to take some beckoning from the way nature is organized.  I know there's a big so-called heresy in modern world, the naturalistic fallacy, that you're not supposed to look to nature to get any sense of how things should be ordered.  Nonetheless, there is a certain order in the arrangement of being and eminent powers within the being that we should keep as part of our guiding principles in medicine and plastic surgery does raise some challenging new questions that we should take seriously.

Having said that, I want to get back something much more pedantic or more procedural.  When Mike brought up the question of the scope of our inquiry and made, I think, the important contribution that we should look to the experience of comparative cultural approaches and different social practices and starting assumptions, that's a really good idea.

I think we should also extend that a little bit within our own sphere because it struck me this morning as we were hearing about the number of organs versus the number of transplants, that there's something implicitly nonequal about those two statistics.  The yearly transplants are not the same as the number of people on the transplant list.  Those people live for years.  So we need to do a sort of statistical analysis that show how many people really are not receiving organs who rightly could receive them.  Obviously, the — I think that's maybe obvious what I just said.  It's just simply a matter of kind of a magic of numbers.  If somebody is on the list for five years, you don't compare the yearly rate of donation to the actual need on the year-to-year basis.

Second, it would be useful if we're going to do this kind of inquiry to request perhaps for the organized bodies some kind of an analysis of outcomes, true added years and how they relate to the age of donor and recipient and I think this isn't a very popular comment to make because I don't want to dissuade anybody from donating if it's a positive thing to do.

But I think in all honesty we have to ask ourselves the question of: Are there any adverse outcomes?  We've heard a little bit about that in previous presentations, but let's be honest about it.  You have two kidneys.  Why do you have two kidneys?  Is it because people historically or all antecedent animals had some ongoing kidney damage from infections?  We now have antibiotics.  We have probably much more healthy kidneys at 50 years old than in people in the past who were not treated for a urinary tract infections for example.

But we should ask ourselves and we should all honestly look if there are any downsides before we make any recommendations.  That should be an honest part of our inquiry.  Does donation at once involve some risk to the individual who makes the donation and that wouldn't necessarily preclude it?  It might actually increase the dignity of the donation and the depth of the gift, but we should admit that.

And finally, we should explore more of what Eric was mentioning in the positive outcomes and somebody should do some kind of analysis on that as part of the scope of our inquiry.  Because if it really is a really deep engagement of another possibility like an invitation not an obligation, it might be a very positive invitation to our civilization.  But let's not start with the assumption that there are superfluous parts that are just there that we don't really need. It might be a genuine sacrificial gift, a very high invitation, to our deepest humanity.


DR. CARSON:   First, I would like to thank Dr. Foster for putting the salary of neurosurgeons into the proper perspective.  You know as a surgeon I would like to say that certainly we're not terrified when we go into the operating room, but certainly there's a healthy respect for what's being undertaken and the degree of urgency of the situation I think plays into it.  If you're going in to do something that's lifesaving and there's no question about that, you're probably going to enter that perhaps with a little less trepidation than something that's questionable not only for ethical reasons, but for legal reasons.

But recognizing that surgery tends to be something that works very well for people, I don't particularly like surgery to be honest with you.  But it's something that the Lord gave me talent to do.  I don't like the sight of blood.  Some people find that very amazing.  They say, "You're a surgeon" and I just say, "Would you rather have a surgeon who likes to see blood?"

But the fact, the other thing, I wanted to bring into play here is there have been several mentions of paying people for the procurement of organs and of course, it's usually mentioned in a negative light, but I think we also need to recognize that this is not something that hasn't been done for a long period of time with blood transfusions.  We've been paying people for blood for a very long time.  We pay people for sperm donations.  These are things that in one case can be lifesaving and in another case life creating.  So there is certainly plenty of precedence for that.  It's not to say that it's right or wrong.  It's to say that we need to make sure that we keep all of these things in perspective.

CHAIRMAN PELLEGRINO:   Thank you very much.  Other comments.  I'm glad we're getting into the situation or giving us some advice here which is very helpful.  I can at least make this passing comment.  The intensity of the discussion almost answers some of the questions. 

PROFESSOR LAWLER:   According to this theory of surgeon terror and I agree you guys shouldn't be reading Kierkegaard or anything like that, but the most terrified surgeon should be the cosmetic, plastic surgeon because he in fact does no one any good.  Yet he's cutting on people.  Yet my limited experience, these are some of the happiest and self-confident people around, not to mention well paid or anything.

CHAIRMAN PELLEGRINO:   As long as we're talking about terror, I don't want you to exclude us internist either, risk out of everything.  Okay.  Sorry.  I keep forgetting.  (Turns microphone off.)  I very much appreciate any comments you want to make.

DR. FOSTER:  Since nobody else is, let me make one other comment in response to Floyd's issue of prevention which is a huge problem and as all of you know, but I just want to tell you, it's become a little more complicated and that has to do with the worldwide epidemic of obesity and its capacity to induce diabetes which is the leading cause of renal failure in the world and the interesting thing is that this whole epidemic does not require medicines, surgery, anything else.  It just requires eating fewer calories.  That's all.  I mean, Type II Diabetes is curable right now and you don't have to get pancreas transplants.  Yet the epidemic is hugely increasing in countries that you never thought to be able to see obesity, France and so forth.  It was just us and so forth.

So the problem is that Gazzaniga is going to hop all over me, but at least the people who are working on addiction that I know about now begin to talk about hedonic.  I think they also say hedonistic, but hedonic neurons where there's pleasure and fulfillment involved.  They're coupled with all of these things.  So you can't — I've talked to I can't tell you how many people who weigh 400 pounds and who have renal failure, early renal failure, and I say, "Miss So-And-So, if I were you I would have my mouth wired together and not eat another bite until I had lost 200 lbs.  You don't have to get back to normal weight.  You just have to do it."

So we have a problem there and it's not just because McDonald's is there.  It's not genetic in the sense.  It's too fast for genetics to be here.  So it's we just can't get people to quit smoking or to quit eating and so forth.  So it's going to be a real problem, but it's a little more complicated than that.  Although I should say that many of you know about new drugs like rimonabant.  Rimonabant binds the canniboid receptor I which is where marijuana hooks in, but we now know that there are normal canniboids.  The universe doesn't give us receptors so we can take opium, the opiate receptors.  It doesn't give us a canniboid receptor so you can smoke marijuana.

But one of the side effects we've known is  that the canniboid receptor then crosses over to the micro-opiode receptor.  It hooks in.  That's why it enhances the pain release with marijuana.  But if you block this, it must have some effect on the hedonic pathways because 25 percent of people who are smoking quit cold on this and there's a significant weight loss with that.  So there may be some possibility that the scientific approach would be a way that we could begin to bring this in an increase in fatty acid oxidation.  So we can't do it by what the self-responsibility should be to just cut down on what you eat, but we have to look at this and we usually treat lung cancers even though they're due to smoking.

Now here's the complication and it's really quite new.  The reason that obesity makes you  get diabetic if you have diabetes as a gene is that it gives you insulin resistance so insulin doesn't work.  All Type II patients have insulin resistance.  They have a high levels of insulin in the blood but it doesn't work because you have resistance and then if you become obese too, it moves the time.  That's why the leading cause of diabetes in pediatric practice now is Type II diabetes which didn't used to start until you were 40 years old and so forth.

Here's the problem.  Gerald Reaven at Stanford University was the one who described what's called a metabolic syndrome.  This is a syndrome that predisposes to diabetes associated with diabetes and so forth.  This obesity by the way is now the leading  cause of liver disease in the country, more than alcohol, more than anything else.  Fatty livers due to obesity is the leading cause just like it is leading to kidney failure with diabetes.

What Reaven has discovered is that 25 percent of us that are normal weight and have no diabetes have insulin resistance and he has now followed a group of these people for ten years.  They are normal people and they have the same increase in vascular disease, stroke and atherosclerosis as diabetics and so forth do.  So it gets more and more complicated.  We don't know what causes this, but even if we cut the weight loss down, it will help.  We still may have a problem with some of these other things going on.

Professors like to tell you about new stuff in science.  So I thought that that's not very well known.  There's a new paper in cell about this, about the insulin resistance, in and of itself being the cause of vascular disease that goes on.  I hope that's clear.

CHAIRMAN PELLEGRINO:   Professor Schneider.

PROFESSOR SCHNEIDER:  And before we leave that topic because I've spent a good deal of time with kidney patients, I do want to say that there are a lot of them who have inherited their disease and got it for reasons that have absolutely nothing to do with the virtue of their behavior.  But I wanted to obey the request to comment on this as a topic and I'm not quite sure how to do that because it's not clear to me what you exclude as another topic by choosing this as a topic and I certainly can think of a number of topics that are equally interesting. But it's obviously a topic of social importance that is directly relevant to the kinds of questions that we're talking about.

I would like to say two things.  First, we are not the first people to think about this.  Socially, we have not leapt into this unthinkingly.  We have actually moved very slowly in making transplants more available and in assaying small experiments, very incremental kinds of experiments to try to increase the pool and each step has been taken  I think actually quite thoughtfully.  So I hope that we don't neglect in our anxiety to think about things basically, the considerable amount of social thought that has already gone into this.

Second, I confess that I am still failing and I have no doubt that it's my failure and not the failure of my preceptors to understand all of the reasons that it is disturbing to cut into a healthy body in order to help another person.  I sometimes wonder whether it helps to think in the language of all things of economics.  If you have interdependent utility functions with somebody else, it's perfectly easy to understand why cutting into your body to help somebody else is no big deal and the idea that it's possible to understand it if you're doing it for somebody you love, but almost inhuman to quote from one of the papers "to do it for somebody whom you don't know" just reminds me of what I read some years ago about the Good Samaritan and the question who was your neighbor.

So to come back to where I started the discussion off, I am still very much at a loss, while granting that it's important to ask these questions, I'm still very much at a loss to understand what it is particularly about the donation of your organs that is in some way interfering with your integrity as a person and with the function that doctors ought to have.


MR. COHEN: I wonder if I might quickly try again to respond first just very briefly on the issue of the almost inhuman.  That cuts in both directions.  There is both better than human and then less than.  I mean there's a certain sense in which giving an organ to a stranger simply as an act of charity or altruism or even love is in some sense better than perhaps most of us are willing to do.  But there's also something strange about it and that's why people who are purely anonymous or altruistic donors go through a kind of rigorous psychological screening in fact to decide to whether this is a freely made decision and a decision that is truly informed.

But on the deeper question about how do we understand the meaning of doing surgery on the healthy, introducing now that it's a theory of terrified physicians.  But presumably we have to think about the acceptable level of risk.  Right?  In the kidney case, it seems pretty clear to me that this is an acceptable level of risk.  There are some outcomes that are bad.  There's a fairly low, but a real risk of mortality for the healthy donor.  But it seems to me both morally justifiable and in many cases morally heroic to do the surgery that removes an organ, a kidney, from the living donor to put it into someone who is sick and whose very life hangs in the balance.

At the other extreme, it would be the case of the parent who wants to donate a heart to his dying child.  One can understand the nobility of the motive and the desire for the parent to save the child and perhaps give the rest of his organs to other people who might be saved.  You could save many lives at the cost of one, but obviously no surgeon would even contemplate performing such a surgery.

Somewhere in the middle we have to decide what is the acceptable level of risk.  I think that's something that probably has to be made a judgment case by case, family by family, doctor by doctor.  I don't think there's one formula.  But again, I don't think we should ignore the moral dilemma here, the dilemma that exists even in the low risk cases.  It gets even more and more complicated for us as you go from removing a kidney to removing a part of the liver and I think we can't ignore the moral difference in that kind of surgery compared to other kinds of surgeries where the patient is sick and the medical intervention is the best effort to try to help them.

CHAIRMAN PELLEGRINO:   Thank you.  I think we are at the time for the break.

PROFESSOR McHUGH:  You just asked that we should all volunteer.  Now you're going to shut me off.  You're a tough chairman.

CHAIRMAN PELLEGRINO:   We'll watch you, Paul.

PROFESSOR McHUGH:   Anyway, let me just make the simplest points that I had made somewhat before that first of all our issues of getting the organs and getting them from both loved ones and from the deceased will really depend upon doctors themselves being more engaged on both the donor and the recipient  or it's going to be a cash market thing.  Those are the two things that are going to go if human organs are going to be the only way.  And I said it the last time.  I believe that the major solution here ultimately is going to be xenotransplantation and we need to know where we are in that arena.

I absolutely agree though with what was said by Gil and what was said by Eric and also it was said by Peter that I don't want to find us in a situation where poor people are exploited and are forced into it and led to believe that they must do this as an act of desperation.  That's not a new idea by the way.  In literature, that's spelled out. I think Les Miserables has a description of that similarly not with anything so serious as an organ transplant.

So I think that one of the places that this Council should be since it's discussed the importance of research both in what Floyd says going backwards.  I think it should also talk about the very great importance of cultivating xenotransplants as the solution really for these things.

CHAIRMAN PELLEGRINO:   I think we're at the point now of our break.  Return at 3:45 p.m.  Again, a comment.  Almost everybody has commented on this and again we'll take that under serious consideration.  Off the record.

(Whereupon, the foregoing matter went off the record at 3:31 p.m.and went back on the record at 3:52 p.m.)


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.


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.


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.


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.


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.


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.


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.)

  - The President's Council on Bioethics -  
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