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THURSDAY, JUNE 22, 2006


Session 1: Organ Transplantation and Procurement— The Empirical Context 

Laura A. Siminoff, Ph.D., Professor of Bioethics, Oncology, and Family Medicine, Case Western Reserve University

Neil R. Powe, M.D., M.P.H., 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

CHAIRMAN PELLEGRINO: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.

(Applause)

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.

(Applause)

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?

Please.

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.

CHAIRMAN PELLEGRINO:  Dr. Rowley?

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. 

CHAIRMAN PELLEGRINO:  Dr. Kass.

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.

CHAIRMAN PELLEGRINO:  A small one.

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. 

CHAIRMAN PELLEGRINO:  Dr. Meilaender?

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. 

CHAIRMAN PELLEGRINO:  Dr. Carson.

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.

CHAIRMAN PELLEGRINO:  Dr. Gazzaniga?

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?

CHAIRMAN PELLEGRINO:  Dr. McHugh.

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. 

(Applause)

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.


  - The President's Council on Bioethics -  
 
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