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Meeting Transcript
December 2, 2004

The Stephen Decatur House
1610 H Street, NW
Washington, DC 20006


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

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

Francis Fukuyama, Ph.D.
Johns Hopkins University

Michael S. Gazzaniga, Ph.D.
Dartmouth College

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

Mary Ann Glendon, J.D., L.LM.
Harvard University

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Charles Krauthammer, M.D.
Syndicated Columnist

Peter A. Lawler, Ph.D.
Berry College

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

Gilbert C. Meilaender, Ph.D.
Valparaiso University

Diana J. Schaub, Ph.D.
Loyola College

James Q. Wilson, Ph.D.
University of California, Los Angeles



CHAIRMAN KASS:  Good morning.  Welcome to this, the 19th meeting of the President's Council on Bioethics.

I would like to recognize the presence of Yuval Levin, who is the designated federal officer, in whose presence this is a legally-constituted meeting.

Before coming to the program, I, with some sadness, have to announce that Dick Roblin, who is our Scientific Director, will be stepping down from that position at the end of this calendar year, a position that he has filled with consummate skill, grace, and devotion for the three years of the Council's existence.

When I was first appointed to this position, Dick, who was an old friend of now over 40 years from our graduate student days, expressed a willingness to interrupt his career plans for a year and to give me and us one year of service as the Scientific Director.  That one year has grown to three, involving heroic commuting, two daily 90-minute commutes from Frederick, and he has given all of us, and me in particular, the benefit of his extraordinary probity and judgment, his dependable penchant for care and precision, and his insistence that all of our work conform to the highest standards of scientific and other sorts of reasoning and evidence.  All parts of our reports, but especially the scientific parts, have benefitted immensely from his knowledge and critical acumen.

The only saving note of this is, I'm happy to add, that Dick has agreed to continue as a senior consultant on scientific matters to the staff, cutting down to a day or so a week.

Dick, all of us on the Council applaud your work and are deeply grateful for your outstanding service.


This meeting is devoted to three subjects of ongoing interest to the Council:  ethical and social issues of an aging society, the regulation of the uses of biotechnology, and, with a novel twist, embryonic stem cell research.  The topics will come in that order.

Members will recognize these remarks from the Chairman's letter, but I would like to put them on the record.  After the last meeting in discussions with members of the Council, we identified at least three pieces of this aging and dementia topic that were ripe for possible Council reporting and recommendations.

First of all, an overview of the looming "crisis" in long-term care, to be presented in humanistic as well as medical and economic terms.

Second, an evaluation and critique of the growing reliance on advance directives as the primary means of dealing with critical decisions in the care of people incapable of making their own decisions.

And, third, a consideration of possible substantive ethical guidelines for deciding how vigorously to intervene medically in patients with advanced dementia.

These topics grow out of things that we have heard here beginning in April.


CHAIRMAN KASS: In this first session, we will be returning to a theme that was introduced to us in the June meeting by Thomas Cole, whom we welcome back to the Council.  Since we last saw him, Professor Cole has been appointed Professor and Director of the McGovern Center for Health, Humanities, and the Human Spirit at the University of Texas-Houston School of Medicine.

In June, Professor Cole presented a paper, "What Does It Mean to Grow Old?", richly illustrated with iconographic illustrations that illuminated the absence, in our time, of a clear cultural script for the meaning of old age, precisely at a time when most of us can expect to enjoy a fair stretch of it.

He raised for us really one of the very most fundamental questions, rarely asked and rarely discussed, which is to say, what is old age to be like in the New World?  Such questions — though they don't immediately lend themselves to specific policy recommendations, consideration of these questions, it seems to us, is crucial to thinking soundly and wisely about public policy.

As a result of conversations we had after that meeting, we have commissioned Professor Cole to develop further the ideas that emerged in the June discussion, and we look forward to hearing his presentation, giving us an overview of a paper, which you have at your place, newly arrived (at least an early draft of this paper), "After the Life Cycle:  The Moral Challenges of Later Life".

Before letting Professor Cole begin, I would also like to welcome Professor Carl Schneider, who is the Chauncey Stillman Professor of Ethics, Morality, and the Practice of Law at the Law School of the University of Michigan.  He will present in the second section.

Welcome to both of you.  It's nice to have you here.

Professor Cole, the floor is yours.

DR. COLE:  I very much appreciate the chance to return and to really, in particular, respond to a question that Bill Hurlbut asked at dinner when itwas too late to be coherent.  Basically, he asked, how should we be thinking about the moral and spiritual sources of inspiration in later life?  Here is an attempt, a first attempt, to think about that with you.

Here's just a quick overview of what I'll be covering.  After my introduction, I'm going to talk very briefly about the normativity of the life cycle.  I do this with some hesitation, knowing that people here have written elegantly about the normal and the natural and the moral.

Then I'll talk briefly about the modernization of the life cycle, basically, showing how we don't really have a life cycle anymore in our culture; what we have is a life course.  We really have a life course, not a life cycle.

Then I'll begin to get into the meat of what I've tried to think about, which are, what are the moral challenges that older people face, both people who are healthy and relatively physically intact, and those who are frail and unable to really carry out the activities of daily living?

In almost 30 years of reading and writing about later life, my favorite book is still a very slender volume by the Catholic theologian Henri Nouwen and a co-author named Walter Gaffney.  It's entitled, "Aging:  A Fulfillment of Life," written in 1974.  Like many books on aging written in the seventies and eighties, Nouwen really goes after negative stereotypes and attitudes toward older people.  He's trying to offer us images and ideals that emphasize solidarity, based on our shared humanity in the universal process of growing older.

The book's central motif if a large wagon-wheel leaning against a birch tree in the white snow, beautifully photographed.  The photo invites us each to think of ourselves as a spoke on the great wheel of life, part of the ongoing cycle of generations.  It implies that each of us has our own life cycle to traverse, a moving up and a going down, a moving forward, yet somehow also coming back to the beginning in relationship to generations before us and after us.

It resembles the Christ-centered circular life cycle from the medieval period which I showed last time that I was here.  But while medieval Christians considered earthly time as a mere shadow of eternity, the late 20th century Catholic theologian asserts that we have only one cycle to live and that living it is the source of our greatest joy.

Well, modern western culture, since the Reformation, has placed great emphasis on the affirmation of everyday life, on relief of suffering, and on the respect and dignity and rights of individuals.  So, as a modern, therefore, Nouwen sets the issue of a good life squarely in the province of everyday living.  He leans heavily on Erikson's work, which I will come to, and he writes that our greatest vocation is to live carefully and gracefully.  Aging then becomes the gradual fulfillment of the life cycle in which receiving matures in giving and living makes dying worthwhile.

With elegant simplicity, he describes a three-stage life cycle as it cogwheels with previous and future generations.  The restful accomplishment of the old wheel tells us the story of life.  Entering into the world, we are what we are given, and for many years thereafter, parents and grandparents, brothers and sisters, friends and lovers keep giving to us, some more, some less, some hesitantly, some generously.  When we can finally stand on our own feet, speak our own words, and express our own unique self in work and in love, we realize how much is given to us.

But while reaching the height of our cycle and saying, with a great sense of confidence, "I really am," we sense that to fulfill our life, we are now called to become parents and grandparents, brothers and sisters, teachers, friends, and lovers ourselves and to give to others, so that when we leave this world, we can be what we have given.

Now I must say I love the lyrical beauty of this passage and, in particular, its view that an individual's personal development naturally entails self-transcendence and moral responsibility in later life.  As he puts it, "receiving matures in giving."

But contemporary American culture seems to emphasize individual development without a clear consensus or even a rich debate about the meanings of later life and the responsibilities of older people to future generations.  With the rise of mass longevity and the ever-lengthening life expectancy, the roles, responsibilities, virtues, vices, and meanings of an extended life take on urgent meanings in both public and private life.

Strangely, there is almost nothing written on this topic.  There's a plethora of literature which focuses appropriately on the ethics of caregiving, on private and public responsibilities to older people, on the rights of older people, but there is virtually no discussion of the reciprocal responsibilities of older people.

In the bioethics literature, older people or their proxies are viewed solely as bearers of rights, as individuals entitled to make their own choices regarding health care, but there is precious little work on the content of those choices or on the larger issues of accountability, responsibility, virtue, and vice in later life.

So let me contextualize this issue with a brief interpretation of Nouwen and of Erikson, on whom he really basically relies, focusing on the normative dimension of their views of aging and the life cycle.  Then I'll offer an historical argument that we are living after the life cycle, both normatively and structurally.  Finally, I'll provide a tentative sketch of the moral challenges of later life for both healthy older people and those who are frail and sick.

Let me begin with a brief analysis of Nouwen's perspective and that of his more famous counterpart, Erik Erikson.  Philosophically, Nouwen's view rests on an ancient doctrine shared by Greeks, Romans, and Christians alike, that the human lifespan contains a single order, it's a natural order, and that each stage possesses its own characteristics and moral norms.  "Life's race course is fixed," wrote Cicero in De Senectute.  "Nature has only a single path, and that path is run but once, and to each stage of existence has been allotted its appropriate quality."

With the rise of Christianity, this normative life cycle is folded into a divinely-ordained natural order, and the stoic ideal of rational self-mastery is replaced with a journey to salvation.  Nouwen writes as a Catholic.  His view of the life cycle is couched mostly in secular psychological terms which echo Erikson's famous psychoanalytical formulation in the "Eight Ages of Man," each with its own cycle/social conflict and corresponding virtue.

First formulated in the mid-twentieth century, Erikson's version of the life cycle virtually dominated American academic thought and public imagination for over 25 years.  I think Erikson's theory is actually a restatement of the stoic ideal, supplemented by evolutionary and psychoanalytic theories.

Like the Stoics, Erikson argued that the cycle of life contained its own stages, each with their own moral norms and struggles.  He saw virtues as not as lofty ideals formulated by theologians and moralists, but rather as essential qualities rooted in human evolution.  As he put it, "Man's psychosocial survival is safeguarded only by vital virtues which develop in the interplay of successive and overlapping generations living together in organized settings."

I don't want to spend too much time on Erikson.  Most people are very familiar with him.  The key virtues that he emphasizes are integrity and experience which conveys some world order and spiritual sense, no matter how dearly paid for.  It is the acceptance of one's one and only life cycle as something that had to be and that, by necessity, permitted no substitutions.

Wisdom, therefore, is described as detached concern with life itself in the face of death itself.  It responds to the need of the oncoming generation for an integrated heritage and yet remains aware of the relativity of all knowledge.

Erikson understood that the life cycle itself does not biologically generate prescribed virtues, values, and behaviors associated with each stage.  Rather, every version of the normative life cycle is created by forces of biology, culture, demography, history, social structure, and patterns of family life.

Many of his followers, however, tended to treat the eight ages of man as if it were a universal paradigm of human development.  In my view, the model that developed through Erikson and used by Nouwen really should be understood as the culmination of the modern western life cycle ideal first imagined in early modern Europe and then fully realized in the middle third of the 20th century.

But the irony here is that modernization removed the traditional structural underpinning of the normative life cycle and replaced it with the life course.  So in both modern and post-modern society, old age emerges as an historically-unprecedented, marginal and culturally-unstable phase of life.

So herein lies the poignancy of our situation:  We are living after the life cycle, and in this context, Erikson's extensive life cycle writings take on an almost numinous quality.  They offer hope for an ideal of the life cycle we desperately want to believe in.

But however attractive, Erikson's ideal could not accommodate the social, cultural, and demographic complexities of our era.  We need a richer, pluralistic dialog about how to live the ever-lengthening years of our later life.

But, first, let me briefly sketch this historical context of our uncertainty about roles, responsibilities, purposes, and meanings.  I'm not going to go through each of these topics in any detail, but I basically want to make the point that the modern life course, as opposed to the ideal of a life cycle which is lived in a place in which generations after generations live together and cogwheel with each other, the modern life course begins in an urban, industrial society.  The older bonds of family and status and locality are really loosened, and individuals become increasingly encouraged to see their lives as careers, as sequences of expected positions in school, at work, and in retirement.

So by the third quarter of the 20th century, western democracies had pretty much institutionalized this life course by providing age-homogeneous schools for youthful preparation, jobs organized according to skills, experience, and seniority for middle-aged productivity, and publicly-funded retirement benefits for the aged who are considered too slow, too frail, or too old-fashioned to be productive.  This is often referred to as the three boxes of life:  education for youth, work for adulthood, retirement for old age.  And old age is then roughly divided into a period of active retirement, supported by Social Security and pensions, and a period of frailty supported, additionally, by Medicare, Medicaid, and private insurance.

So, again, the cycle of life becomes essentially severed from the course of life in modernity.  Again, when people lived in farms and villages, small towns, local traditions of practice and belief and behavior provided the external norms as each generation visibly cycled into the next, and the problem of identity did not arise.

But, as we've seen, this is really no longer the case in an urban, industrial, and now post-modern society.  As the British sociologist Anthony Giddens puts it, "The idea of a life cycle makes very little sense once the connections between an individual life and the interchanges of generations have been broken."

So, until the last quarter of the 20th century, this institutionalized life cycle which effectively had structurally and in some ways normatively undermined the cycle of life, it was fairly stable.  But, by the 1970s, what you found was an unraveling of this institutionalized life course, a powerful movement by older people and their advocates to overcome negative stereotypes of older people as inevitably frail and dependent.

Then in the eighties we saw a rebellion against the bureaucratized life course and against restrictive age norms.  Writers and scholars called for an age-irrelevant society that allowed more flexibility for moving in and out of school and the workforce.

At the same time, serious doubts about the proportion of the federal budget devoted to old people were voiced in the name of generational equity, as were fears of an unsupportable public obligation to sick and dependent older people.  As we've seen, political support for the welfare state began to erode.

So, finally, the problem of the transition to an information economy has made things even more culturally and psychologically unstable.  Amidst a globalizing economy, declining corporate commitment to long-term employment, to seniority, and defined pension benefits, there has been a steady erosion of the expectation of income stability in retirement.

Zygmunt Bauman characterizes the result of a speedup of life in the Information Age and the decline of long-term stability and benefits in the corporate life as resulting in kind of an ontological insecurity which is especially apt for older people.  He writes, "The boundaries which tend to be simultaneously most strongly desired and most acutely missed are those of a rightful and secure place in society, a place where the rules do not change overnight and without notice.  It's the widespread characteristic of men and women in our type of society that they live perpetually with the identity problem unresolved.  They suffer, one might say, from a chronic absence of resources with which they could build a truly solid and lasting identity, anchor it, and stop it from drifting."

So identity, then, is not merely a personal issue.  It has much broader social implications, and I believe it's crucial to the development of wisdom and to knowing one's responsibilities.

So how are we going to think about the moral life of older people after the life cycle?  Well, even Erikson realized early on that there's a basic problem built into sort of western ways of thinking about the life cycle.  In 1964 he wrote, "Our civilization does not really harbor a concept of the whole of life as do the civilizations of the east.  As our world images a one-way street to never-ending progress, interrupted only by small and big catastrophes, our lives are to be one-way streets to success and sudden oblivion."

So the absence of a culturally-viable life cycle set within a larger frame of transcendent meaning makes it difficult for many people to grasp possibilities of spiritual growth and moral purpose amidst physical decline.

In his seminal work, "After Virtue", Alasdair MacIntyre argues that we no longer possess a commonly-shared moral language and that, in a world of moral strangers, the only alternatives are Aristotle or Nietzsche, which means basically tradition or chaos.

So, by analogy, I think we're living after the life cycle, after the collapse of widely-shared images and socially-cohesive experiences of the life cycle.  But I do not think that we are forced to choose between idealized tradition on the one hand or exaggerated chaos on the other.

First of all, the lack of a scholarly literature or articulated norms does not imply that most older people are leading morally-incoherent lives.  And, secondly, the very search for identity itself I think holds important moral promise.

So here I'm going to briefly just draw on the work of Charles Taylor, who believes that, despite the moral limitations of liberal individualism, the Biblical tradition he believes lives on as a kind of underground moral resource in most lives, and for Taylor selfhood or identity is inextricably bound up with some historically-specific but often unarticulated view of the good.

So for Taylor, then, the attempt to be authentic need not degenerate into self-indulgence and motivism or moral relativism.  He thinks that a person in search of identity always exists within a horizon of important questions which transcend the self.  Attempts at self-definition and self-fulfillment that ignore questions and demands outside the self suppress the very conditions of meaning and purpose.  As he writes, "Only if I exist in a world in which history or the demands of nature or the needs of my fellow human beings or the duties of citizenship or the call of God, or something else of this order, crucially matters, can I define an identity for myself that is not trivial."

So my point here is that we should not view the search for identity in old age as a narrowly-personal quest.  Of course, we're all familiar with examples of late-life Narcissism, but the effort to live an authentic life is itself a moral ideal, an attempt to understand and fulfill the uniqueness of each life.  Older people trying to make sense of their past and imagine their futures through various forms of life review, spiritual autobiography, reminiscence, storytelling, life story writing groups, and so on, these people are doing important moral and spiritual work with genuine implications for others.  Those who are passionately involved in the arts, in public service, and in new forms of exploration begin to exemplify models of elderhood.  As Erikson puts it at the end of "Childhood and Society", "Without elders who possess integrity and identity, children will be unable to trust."

So authenticity, basically, by itself is not going to be able to provide standards of conduct and character to guide moral development in later life.  Authenticity provides no reasons to restrain the person who authentically chooses selfishness or evil, and it contains no intrinsic norms or prohibition.

Perhaps the dominant ideal of later life today is what the Austrian sociologist Leopold Rosenmayr calls "Die Späte Freiheit," "the late freedom."  Free from social obligations, retirement for those who possess good health and adequate income is equated with leisure activities:  visiting family and friends, golf, mahjong, bridge, travel, taking up new hobbies, attending classes at elder hostel, institutes for learning in retirement, visiting family and friends.

The problem here is not that these activities are wrong or bad, but they are based on the concept of "freedom from," freedom from obligations that we have at midlife, with little or no attention paid to what the freedom is for, which principles or commitment should guide the choices being made.

Today senior marketing and advertising specialists have, I think, the primary influence on activities, programs, and products for seniors looking for ways to spend their free time.  And maintaining one's health is the primary goal spurred on, I think, by the commodification of the body.

So the next real ideal after authenticity and freedom seems to be the ideal of health, and, of course, services, products, and programs for healthy aging are probably the most lucrative segment of the senior market.  Health is becoming increasingly construed as physical functioning that's divorced from any reference to meaning or human purpose.  The reduction of health to physical functioning fits hand-in-glove with the notice of freedom as unfettered choice.  Let me give you an example.

In the 1970s, the biologist Alex Comfort wrote two popular books, The Joy of Sex and The Good Age.  Comfort celebrated in both of these books technique, functioning, achievement.  Well, in the early eighties, I invited Comfort to participate in a Conference on Aging and Meaning, which, by the way, is the Conference where Bill May gave his prescient paper on the virtues and vices of aging.  In a letter he wrote back to me, he bluntly declined to participate on the grounds that he had no interest in "grannyology."

Well, this response I think reveals the obvious disdain for older people, single-minded focus on control and functioning, and a common but rarely articulated discomfort or contempt for existential concerns that underlies most discussions of successful aging today.

More specifically, by linking sex with age and achievement, Comfort anticipated the contemporary redefinition of sexual decline and impotence — these are things which occur in individuals — into treatable sexual dysfunctions which occur in organs; again, another way in which medicalization has separated the images and ideals of illness and disease from actual people.

I think one of our options here is to try to reclaim the notion of health suggested by the AAMC.  "Health is not just the absence of disease, but it's a state of well-being that includes a sense that life has purpose and meaning."

So, given the limitations of authenticity, of individual freedom, and of health as adequate ideals, how should we begin to explore the moral challenges of aging?  Ronald Blythe offers this penetrating, if harsh, starting point, which Bill May also used in his essay.  "Perhaps with full lifespans the norm, people may need to learn how to become aged as they once learned to be adult.  It may soon be necessary and legitimate to criticize the long years of vapidity in which a healthy elderly person does little more than eat and play bingo or who consumes excessive amounts of drugs or who expects a self-indulgent stupidity to go unchecked.  Just as the old should be convinced that whatever happens during senescence, they will never suffer exclusion, so they should understand that age does not exempt them from being despicable.  To fall into purposelessness is to fall out of real consideration."

Now that sounds harsh, but, actually, his interviews with older English people both in the countryside and the city was incredibly humane and wonderful.  That's a wonderful book which is not judgmental about older people.

So the point here, I think, is that learning to grow old is, indeed, an important concern in our aging society, and it calls for human development policies.  We need job retraining, creative use of leisure time, lifelong learnings, stimulation of volunteer networks and self-help groups.  These kinds of things help people develop the skills and the strengths to solve their own problems.

As Harry Moody has pointed out, aging policy that responds only to problems intensifies the depreciation of the strengths and capacities of older people and may inadvertently increase the tendency rather than try to prevent it.  Falling into purposelessness is not only a matter of individual will and character, but it's also a matter of culture and public policy.  Old people, like all people, they need to be needed.

Well, in approaching the moral challenges of aging from the point of view of the aging person, I've really always appreciated Rabbi Hillel's ancient three questions:  "If I am not for myself, who will be for me?  If I am only for myself, what am I?  If not now, when?"

I take each of these questions to stand for a phase of the life cycle, harkening backs to Nouwen's formulation.  As children and adolescents, there's a natural tendency to see the world as one's oyster.  In midlife we realize that to mature we must attend to the needs of others, and in later life, with time running out, we must learn how to balance our needs against the interests and needs of others.

Interestingly, whereas Nouwen speaks only of giving as we age, Hillel speaks of balancing competing needs and interests.  So if we take Hillel's questions and apply them to later life, I think we can begin to specify key questions which demand careful and balanced responses.

As citizens, what responsibilities do we have to our community and the larger society, to the poor and the vulnerable, to our communities of faith?  How do we balance these against our personal interests?  What are our responsibilities to our children and grandchildren for caregiving, for economic support?  Again, how do we balance these against our own needs and interests?

What responsibilities do we have for older parents who may be in their eighties, nineties, or even a hundred?  And, again, how do we balance these with our own personal interests and well-being?

What responsibilities do we have to future generations to help safeguard the environment, to work for sustainable sources of energy?  What responsibilities do we have for a spouse who is permanently disabled perhaps by the later stages of dementia?  Can we say, as some people do, "This isn't the person I married and I need to live my own life," or do we owe a degree of loyalty that includes daily visits and ongoing care?

Recently, you may have seen the movie and read the book "The Notebook" by — I'm blocking on his name.  Anyway, it's a love story in which it goes back and forth between the present with a severely-demented wife and her husband and the past when they first fell in love.  It's based on a continuing daily visiting which ends in somewhat sentimental but actually quite beautiful restatement of their love.

What responsibilities do we have to shoulder, depending on circumstances, part of the burden of our own economic support?  What responsibilities do we have for our own health, for exercising prudence in our use of health care responsibilities?  What responsibilities do nursing home patients and residents have to assist each other?  What responsibilities do we have to pursue a path of continued growth and spiritual development which aims at self-transcendence, compassion, commitment to others, acceptance of physical and mental decline, and preparation for death?

I'm not going to attempt to answer these questions.  I want to raise them.  I believe they are urgent and that they call for personal wrestling, public debate, academic inquiry, and perhaps some kinds of public policies.

If we look, for example, carefully at advice literature about aging over the years, we could really see a whole lot about changing values and norms that are conveyed to a reading public of older people.  We need a great deal of social and behavioral study of what older people think about these issues as well as how they act.  We need studies of the moral and spiritual lives of older people in various geographic, ethnic, racial, gender, and class situations.  We need diverse religious reflections and their translation into practical programs and congregational life.  We need philosophical inquiry and public conversation, and we need to listen carefully to the stories of both ordinary and exemplary older people.

I don't think we can expect universally-true, decontextualized norms and values to which all elders should be held accountable.  In a pluralist society, we need to hear from various religious, ethnic, racial, and political groups.  We need to hear, for example, from the AARP, which some people think has actually sold out to the market an enthusiasm of the young-old and is always perceived as a powerful lobbying group on the part of older people.

We need new ideals.  We need new models.  One example is the Spiritual Eldering Project that was initiated by Rabbi Zalman Schacter and sponsors a series of workshops around the country for older people who would like to become real elders in a sense of becoming mentors, in a sense of becoming devoted increasingly to the environment and to the communities that they live in.

There's a civic engagement project currently undertaken in the Gerontological Society where Marc Freedman, for example, has long been working on strengthening voluntary movements of older people, offering their care and their skills with underprivileged urban youth.

But I think we need to step back from some of these more normative applied ethics kinds of questions and recognize the complexity and the nuance that's required to grapple with these moral questions.  John C. Powys' wonderful book on the art of aging ("The Art of Growing Old") writes, "If by the time we're 60 we haven't learned what a knot of paradox and contradiction life is, and how exquisitely the good and the bad are mingled in every action we take, and what a compromising hostess our Lady of Truth is, we haven't grown old to much purpose."

In other words, we need to strive for wisdom and spiritual development to help us understand and respond to the moral challenges of aging.  As Powys points out, life is a "knot of paradox and contradictions."

So what are the paradoxes and contradictions one faces on the way to wisdom?  And, of course, one is always on the way; one is never there.

Well, one prominent paradox is that wise people know that they don't know.  They tolerate uncertainty because they understand the limits of any attempt to grasp the entire truth, especially their own attempts, and they understand the need for multiple points of view.  As Florida Scott Maxwell put it, "I cannot speak the truth until I have contradicted myself."

Wise people cultivate habits of self-examination and self-awareness.  They do not attempt to impose their will on the world, but learn to observe and accept reality as it is, and acceptance changes reality.

Consider the paradox that loss is gain, failed expectations are a precondition for acquiring experience which reflection may turn to growth, or the paradox that, unless a person accepts her own limited subjectivity and the way she projects herself onto the world, she will be unable to work on transcending these things.  Likewise, a person who understands and accepts the transitory illusions of their self-image are then able to go onto a higher level of understanding themselves.

Now these paradoxes and contradictions are not solvable problems.  They must be worked with by each individual in search of spiritual growth, but, of course, this does not happen without guidance and without community.

So our society, therefore, needs to support a variety of contemplative practices, including, for example, prayer, meditation, self-reflection, yoga, tai chi, and so on.  So here we have, again, the ancient problem of the active versus the contemplative life, another contradiction which needs revisiting.

And one of the most important and difficult paradoxes of aging is physical decline and spiritual growth.  How can we learn to work hard maintaining our physical health while at the same time preparing for our own decline and death?  How do we learn to hold on and let go at the same time?

One of the central obstacles to wrestling with the challenges of old age lies in the intractable hostility that America has towards physical decline, decay, and dependence.  Rather than acknowledge these harsh realities, we pretend that we can master them, and we feel like failures when we don't.

So let me turn, then, to moral and spiritual aspects of dependency.  Dependency raises a special range of challenges for older people.  There are no guidelines for how to be a good, dependent person, and I doubt that such guidelines would be a worthwhile goal.

Hence, we must enter first into dependency's innerworkings before we can understand its moral challenges.  Imagine a life in which you cannot walk, cannot carry out your accustomed activities of daily living.  Perhaps you're blind, demented, or incontinent, a world in which you must wait for others to bathe you, take you to the grocery store or to the doctor.  Time stretches before you like a desert.  Shame and self-loathing lacerate for the loss of your independence.  You're tempted to both false displays of self-sufficiency and to letting yourself go completely, lapsing into pure passivity.  Family relationships become strained, especially when caregivers and receivers of care are dutiful playing their proper roles without acknowledging their own and each other's emotional turmoil.

Wendy Lustbader has a lovely book called Counting on Kindness:  The Dilemmas of Dependency.  She makes here an unusual point about mercy.  The old word "merci" originally meant compassion and forbearance toward a person in one's power.  In Latin, "merces" signified payment or reward, referring to aspects of commerce.

"Mercy," writes Lustbader, "is entirely based on exchange.  Giving help eventually embitters us unless we are compensated at least by appreciation.  Accepting help degrades us unless we are convinced that our helpers are getting something in return."

As much as we might prefer to reject this stark accounting, we discover in living through situations of dependence that goodwill is not enough.  A delicate balance exists at the heart of mercy.  Reciprocation replenishes both the spirit of the helper and the person who is being helped.

We seem to lack language to acknowledge the difficulty of receiving.  Hence, the dependent person may feel doubly burdened, disliking the help that cannot be repaid and feeling guilty for the dislike.  Increasing frailty shrinks opportunity to be useful, eliminating external obligations.  No one expects our presence and no one needs our efforts.

Finding ways to be useful requires imagination and will power; for example, among nursing home patients who often figure out ways to help each other.  Feeling useful will sometimes require special sensitivity of the caregiver.

As a geriatric social worker and therapist, Wendy Lustbader spent many years going to the homes of frail elders who were ashamed of their needs and struggled to conceal them.  She once visited a woman who allowed her in because of a sudden illness.  The woman's lightbulbs had burned out.  She was reading by daylight and sitting alone in the dark.  The woman refused to allow Lustbader to stand on a stool to change her lightbulbs.  Lustbader said she hated thinking of the woman unable to sleep, tossing fitfully in her bed and unable to read.

At last, the woman's pride relented and Lustbader changed the bulbs.  "As I left, I thanked her for giving me the honor of helping her."  She understood what I meant, for it was she who was carrying the burden of uselessness and I who was being granted satisfaction.

The next section that I had planned to talk about is the section on virtues and vices.  I think I will skip over most of this because it's provided by the readings that you have from William May and Sara Ruddick, who come at this from very different points of view.

But just let me say, despite an extensive literature research in English, these are the only two articles I was able to find on the virtues and vices of dependent older people.  And I think I would like to offer a couple of words of caution before going into this because I think this is a very dangerous, politically and morally, topic.

For example, friends on my left are going to argue that I'm singling out the elderly for judgment, and friends on my right are going to use moral arguments for responsibility of older people to dismantle necessary state support.  So I want to just sort of say I'm in neither of those camps.

So I think any full exploration of virtues and vices must take into account differences in culture, gender, race, ethnicity, and social class.  And contrary to Cicero's exclusive emphasis on character, exercising virtue is not simply a matter of individual will.  Virtues occur amidst social conditions and relationships which foster or inhibit them.

A given person's capacity for exercising virtue, especially the more subtle and demanding virtues, also depends on her prior level of emotional and spiritual development.  For example, for some people simply carrying out the thou shalts and the thou shalt nots of our society may be a more reasonable expectation than expecting them to be exemplary elders.

So, again, rather than spend time talking about these two essays, which you can read for yourself, I'm going to move on to what I think are the limitations of this kind of analysis and then on to some concluding thoughts, so that there will be some time for conversation.

The one thing I want to say, however, is the importance of humor as a virtue.  Bill May touches on this in his discussion of "hilaritas."  He says, "Humor is a saving grace, allowed by the capacity to see life's experience from a more spacious perspective."

I remember George Burns, who was performing in his nineties, who before he got started, he said, "I want to ask for applause in advance."


So, without trying to compare or contrast May and Ruddick or see what they have in common, I just want to ask, what can we expect from the analysis of character and action among the frail elderly?  And, again, these are issues for the future.

What's missing from these accounts?  Can we educate caregivers on the importance of acknowledging reciprocity and fostering relationships which allow their patients to be useful?  What would relationships look like if moral language and the reciprocity of dependent patients was introduced into geriatric and gerontological education and into nursing homes or home care?  How can we educate clergy, both in the pulpit and at the bedside, in the moral challenges of aging?

Seminaries have only recently begun to provide some gerontological education for their students, but they focus entirely on the needs of older people.  What should be added to revitalize religious understanding of older people as moral agents?

And, finally, with the proliferation of lifelong learning through elder hostels, institutes for learning in retirement, could older people themselves be engaged in seminars, workshops, about the moral issues in their lives?  I'm fairly skeptical about this latter idea since in my experience older people are notoriously absent when you offer a course in aging.  That's something that they don't want to know about.


But I think that the use of Biblical material, films, fiction, theater might slip by their defenses and open up new moral and spiritual horizons.  Think of old King Saul or King David, King Lear, "Oedipus at Colonus," or "Driving Miss Daisy," or "Cocoon" or "A Trip to Bountiful," if these were examined through the lenses of ethics and the human spirit.

So where do these thoughts about life-cycle norms, mass longevity, post-maturity, moral obligation, spiritual development, and virtues and vices leave us?  Where, personally, I feel a sense of awe and amazement at the sheer abundance of life made possible by the gift of mass longevity, but what is the price of that gift?  I think that's an open question and it's a political question in part.

Perhaps, as Theodore Roszak argues in America the Wise, the wisdom of a maturing population promises to be our greatest resource.  I suspect he's overly optimistic, just the way he was when he wrote The Greening of America back in the 1970s.

Perhaps, on the other hand, education and policy will make no difference whatsoever, and in that case we might think, as the Talmud suggests, that a man who is a fool in his youth is also a fool in his old age, while a man who is wise in his youth is also wise in his old age.  I suspect that the truth between these points of view is going to depend on how well we learn to identify, support, and accomplish the moral and spiritual work of aging in our era.

As Plato understood in The Republic, one of the best ways to learn is by listening to those who have traveled this road ahead of us.  So let me close by listening again to one of my favorite elders, Florida Scott Maxwell.  If you don't know her slender volume, The Measure of My Days, I strongly encourage you to take a look at it.

She's writing in her eighties, mid-eighties.  She's very frail, and she's writing from the perspective of a Jungian analyst.  She encourages us to learn that life is a tragic mystery.  She writes, "We are pierced and driven by laws we only half understand.  We find that the lesson we learn again and again is that of heroic helplessness.  Some uncomprehended law holds us at the point of contradiction where we have no choice, where we do not like that which we love, where good and bad are inseparable partners to tell apart, and where we, broken-hearted and ecstatic, can only resolve the conflict by blindly taking it into our hearts.  This used to be called being in the hands of God.  Has anyone any better words to describe it?"

Thank you.


CHAIRMAN KASS:  Thank you very much, Professor Cole.

The floor is open for the discussion of this paper.

Gil Meilaender.

PROF. MEILAENDER:  Thank you.  There's a lot there that I agree with, but it will be interesting if I ask you a question about something that I'm unsure about.

DR. COLE:  Sure.

DR. HANSON:  And it has to do with this notion of the late freedom that you discussed, and discussed as a problem in a way, the sense that we think of our lives as moving toward a freedom that's simply a "freedom from" rather than a "freedom for" something.

I'm always bothered when — and I'll grant this may just be a defect of character, but I'm always bothered when I learn that I have an obligation to continue to grow indefinitely — (laughter) — and that I need lifelong learning, things like that, since I sort of await the day when I can stop worrying about learning.

I wonder if you don't do sufficient justice to that "freedom from" idea.  I mean it is a "freedom for."  As you described it after all, it's a period of life when one worries less about being productive and more about certain relationships with family and friends, and so forth.  Those are great goods in human life, which we might well set over against the good of being productive and think that they are at least as important.  To find that I am given the gift of a time in life when they can take a kind of priority doesn't seem to me to be necessarily something to worry about, but something to be appreciated.

So I wonder if you could just say a little more about what you take to be the problem here, whether there's any truth to the caveat that I've tried to articulate, and just reflect a little more on that notion of the late freedom.

DR. COLE:  Sure.  I think that's a very good question, and I agree with the spirit of it.

I think there's a great deal of good in the late freedom, and it's a freedom we may be increasingly losing as we find that older people are being forced by economic circumstances to retire and go back to work to make ends meet, but I think it's there for a significant portion of the population.  And I think people choose to do wonderful things with it.

A level of volunteering, for example, that people with free time have is pretty impressive.  It ranges pretty much, for people 65 and over, it ranges about 25 percent of people choose to volunteer in some kind of public service.  It's usually in a church situation or religious situation, and they tend to give about 96 hours a year.

They choose to spend time with their children and their grandchildren.  They choose to spend time to read.  And these are all good things.

But I think the late freedom is not a complete idea because I think we do need guidance, more general guidance, and efforts to create ways of understanding our place in a cycle of generations, so that we use our freedom in ways that benefit the next generation.

I've read one theologian recently who argues that the primary obligation of older people is to show the next generation how to die, which is an interesting sort of point of view.  It is more a pre-modern point of view than a contemporary point of view.

So I think it's an appropriate caveat, and I certainly choose to use my late freedom, if I'm lucky enough to get it, to enjoy the hill country in Texas, where we have some land, and it's a beautiful area.  I just want to be there.  I just want to spend time there.

On the other hand, I really have in my mind — and my wife and I were talking about this —  I really have in my mind questions about how much of our resources we ought to put into building a house out there and, as Dan knows, clearing cedar and taking care of the raw land, which in many ways will bring back the native grasses and bring back wildlife, and so on.

How much resources should we put into that versus establishing trust funds for our grandchildren?  So if we put a thousand dollars a year in a trust for each of our grandchildren, by the time they're 18, with any luck, most of their college expenses will be paid.  And what about siblings who have not flourished, but who may need help when they get older because they don't have adequate savings?

So, again, it is a question of balance.  My hope is that we can explore the late freedom culturally, personally, and publicly in a more thoughtful way, and especially in ways that are not manipulated by consumer society, which wants to tell us how to buy our health, how to buy potence, how to buy health and happiness, and so on.

Anyway, I won't go on there, except to say I accept the caveat and appreciate it because I certainly don't want to come across as somebody who thinks that the late freedom is a bad thing.  I just think we need more reflection on what it's for.

CHAIRMAN KASS:  Mary Ann, and then Mike, and then Paul.

PROF. GLENDON:  I want to thank you for coming back.  I know that when I look back on these years on the Bioethics Council, I'm going to think of your two presentations as among the high points.

I can't find much to disagree with.  There is something I hope that one of your sources is wrong about, and that is the idea that, if you were a fool in your youth, you have to be a fool in your old age.


But what I wanted to ask you about, it's not so much a question as to ask you to say a little bit more about the political implications of those very interesting questions you raise on, I think it's pages 14 and 15 of your paper.  You stressed two things overall, it seems to me.  One is that we're living in an unprecedented situation, and the other is that the past toward coping with the challenges lies in attending to relationships and context.

So here's the problem, I think, when you're trying to imagine what a group like ours might be able to contribute, some of the things that make the situation unprecedented, the greatly increased need for long-term care on the part of so many people suddenly, and at the same time the sharp drop in the availability of paid or unpaid caretakers.

If you could just peer into your crystal ball a little bit, what do you think a group like ours might be able to do to set better conditions for coping with those challenges?

DR. COLE:  Thanks for that question and thanks for the compliment.

I think one thing that can be recommended is the development of human development policies to strengthen people's ability to solve their own problems, to be less dependent, because most of our policies are aimed at solving problems, and appropriately so, but I think there's much that can be done to educate, enhance, give incentives for people to become more independent and more self-sufficient in ways that are gratifying to themselves.

But, of course, the downside of emphasizing that is that I in no way want to add to the current tendency to begin to dismantle the welfare state, and especially Social Security and Medicare.  We know that half of the people who are supported by Medicare would be impoverished without it.  We know that, as you said, long-term care is a looming crisis both in terms of funding and in terms of availability of caregivers.

So that's why I have so much trepidation really in raising these issues.  I guess I would say, from a political point of view, that it's very important to develop awareness and political support for taking care of the most vulnerable, which is a sort of primary principle, and not blaming people.  There is a tendency to blame people for their dependency.

In the 19th century, for example, during a health reform craze, Alexander Graham, who developed Graham crackers, was in a frenzy of health reform, which is kind of the predecessor to health promotion today.  He said, if people were sick, it was because they were not leading good lives, and that if Methuselah, he said if Methuselah had arthritis, it was his own fault, and Methuselah lived to 969 years.  So encouraged commitment of resources and development of community participation in caring for the vulnerable and the needy I think it absolutely essential.

One thing that I've seen in terms of older people volunteering their time, there are some networks around the country in which people sign up as part of a group.  I think this takes place in San Antonio.  When they volunteer their time to deliver Meals on Wheels, to look in on somebody who's house-bound, to help clean, or whatever, their hours are clocked.  They clock their hours over the years, and then when they become dependent, they're entitled at least to the number of hours that they have put in, which is an interesting kind of idea.  So there's an attempt.

CHAIRMAN KASS:  Mike Gazzaniga.  You're first and then Paul.

DR. GAZZANIGA:  This is maybe just a reference that will bridge these two talks this morning.  There's an ongoing, three-year study that has been sponsored by the National Institute on Aging, a report that will be put together by the National Academy of Science on the social implications of people in an aging community.  People are showing growing interest in the nature of the mentation of older people and how that impacts the decisions that they are making in their professions and in their personal social life.

The good news is that, actually, as we age, we get happier.  One of the reasons we get happier is we ignore negative information.


So the actually great body of research that has gone on, to give you an example of it, you show older people a series of pictures, some of which are horrendously objectionable and some very pleasant pictures, and you subsequently test their memory of the two classes of pictures, and they have no memory of the objectional pictures and only of the bucolic ones.  So the point being then that — I kind of feel this myself (laughter) — just getting happier and happier, and so, therefore, maybe I should be removed from certain tough decisions because I ignore or deny the tough data that might make you want to modify your position.

But, anyway, there's a large report that will certainly be of interest to this committee, and to others, coming out on these topics.

DR. COLE:  Yes, I think that's very interesting.  I'm not aware of that.

But I am aware of studies that show in people who are considered old-old that there seems to be a decline in the functioning of frontal lobe brain work, and the implication there is important for ideas about autonomy because I'm not scientifically versed enough to be able to give you the specifics, but when these frontal lobe disorders take place, older people are less able to take initiative and pursue their choices and a course of action.  They're more vulnerable to being influenced by others than they would have been if this functioning was in place, which is an interesting finding, I think, and yet another problem for the idea of autonomy in bioethics.


DR. McHUGH:  I, too, very much enjoyed your talk, and it's wonderful to see you back here.

But I'm following on from a number of the comments already made in relationship to how to understand and give more teeth perhaps to the process of development that you have, I think, happily said has transformed itself from the cycle idea to the stages idea of life.  I've always felt that the cycle idea was pointless.  It didn't talk about the fact that people went through development and learned things and lost things in the process, and that was the natural reason for there being stages.

So when I hear you talk a lot about Erikson and the like, I have to tell you I have a visceral aversion to Erikson.


I'm not quite sure where it comes from, but I think partly it comes from the fact that he was embedded in the Harvard of the 1950s and 1960s where I was embedded, too, and he accepted the commitments and virtues of that place at that time and didn't wonder about stronger virtues.

In fact, part of the difficulty in much of our writing about elderly people and the way we should think about them does emphasize the softer virtues rather than the vigorous virtues, a distinction that I draw from a brilliant woman, Shirley Letwin, who said, we can have both those virtues; you can be both courageous and compassionate; you can both be faithful and nonjudgmental; you can be critical in your judgment and kind, too.

That kind of sense of who we are and how we develop, and how at each stage the vigorous virtues have to be emphasized and given, well, to some extent, given authority, I think falls away often in discussions such as we're having today.  So that's the first thing.  Bill and you both do touch upon the vigorous virtues, but perhaps, in my opinion, not emphasize them enough.

The second thing is that there are reasons why young people have certain responsibilities and older people have other responsibilities.  This was brought home just a couple of days ago when I was listening to a woman who had been embedded with our marines in the Fallujah campaign, and she came to realize that, boy, you've got to be 19 or 20 to go in there and knock down a wall.  She was following after them and she got very foot sore.  She was very brave, I thought, to be with them, of course, and it was wonderful that she was there.  I saluted her for that.  I also salute her for the fact that she realized that hardy and robust youth have these tasks and are ready for them in ways that 40- and 50-year-old people are not.  But that's to emphasize the humorous side.

Perhaps the issue that I want to see emphasized here is what Mike is saying in part.  There are reasons why we are asked to give up certain tasks that we're doing in our lives.  For example, anyone who is going to run a corporation, a department, an organization of any sort needs physical energy; he needs vision, but he also very much needs the capacity to fight entropy.  Everything is always falling apart.  Let me tell you, fighting entropy is an exercise that you weary of in the sense that it begins to fill your week, and you begin to shy away from it.

In fact, to some extent, what Mike is saying is absolutely right:  The reason why old executives need to be replaced is that they have stopped looking at the problems that they need to fight and are accepting them as part of benevolent vision that they have.  You've got to get rid of them.

The Dean and I agreed that, when I reached a certain age, it was time for me to step down as Director, and it did, then, allow me, because I no longer had to fight so much entropy except my own entropy, to emphasize my interest in the vision side of my discipline, and the like, to write more, to think more, to spend time with bright young people, and older people, too, to develop that.

So I missed two things in your wonderful demonstration.  I missed the emphasis on the vigorous virtues and I missed the idea that, in contrast to what Erikson says and this soft stuff, the "open sesame" school of human development (laughter), that's the humorous side.  My mother said I would go far if I forgot that side but didn't emphasize it.


Nonetheless, there are reasons why hardy and robust youth have to be the ones that go into Fallujah; middle-aged folks, educated and powerfully developed and things, need to run organizations.  And, finally, and it's best to take an age somebody should step down if that organization is going to flourish in the future with new people who can fight the entropy that the old have permitted.

CHAIRMAN KASS:  Some of us, those of us who have senior cards, resemble that remark, Paul, but never mind.

DR. McHUGH:  There's truth in it, though, Leon.

CHAIRMAN KASS:  Oh, I was joking.


DR. COLE:  Let me try to respond to those comments which were eloquently put, and I would like to read the source of the woman who wrote about the stronger virtues and the weaker virtues.

But, first, let me say something that I couldn't find any way to say in the paper, so I'll say it here.  My favorite definition of virtue is Jonathan Edwards' definition of true virtue.  It comes from a book he wrote late in life, when he was beginning to think in more aesthetic terms than purely theological terms.

He said, true virtue is absolute love of God and benevolence towards being in general.  I have never heard a statement about the highest virtue that inspires me any more than that does.  Now that's not an answer to any of your questions at all.  It was just a chance to say something I wanted to say.

I should have listed as one of my questions, when do people have a responsibility to step aside?  That's a key issue, and for different reasons.

One, because they may not have the capacity to fight entropy, and the other because they may be holding back the development of people who need to put their stamp on things and have a limited amount of time.

If I understand you right, I think there's a contradiction between your first question and your second question.  In other words, you want to hear more about the vigorous virtues and I need to know more about what they are to understand them, but you also make the point that older executives have a declining capacity to fight entropy in their organizations and in themselves, which would suggest that they don't have vigorous virtues.  That's one of the reasons why they need to step aside.  So I may be missing something there, but it looks to me like there's a contradiction in those comments.

Finally, let me say that I think what you're pointing to here is the difficulty our culture has in making room enough for the contemplative life.  We are a "can-do" society.  We want to get things done.  We don't much respect, although we're seeing a resurgence of this, we don't much respect the virtues of contemplation, of self-reflection, of quiet study, prayer, meditation, the kinds of things which have the capacity, I think, to help people grow quieter, calmer, and more benevolent, even though I understand that Gil Meilaender doesn't really want to have to develop any more because he just wants to be left alone; I feel that way myself sometimes, too.  But, anyway, that's an attempt to respond.

DR. McHUGH:  Let me just respond by saying I see how you could see those two questions as being contradicting one another, and it does depend on what I mean by the vigorous virtues.  The vigorous virtues include things like courage, self-reliance, fidelity, and critical judgment.  Amongst them, of course, would come the recognition that certain powers do decline in that manner, and just as one doesn't try to necessarily join in the same vigorous physical activities with hardy and robust youth when you're in your seventies, so at the same time I think you can have courage and vigor and vision and at the same time say this is an appropriate time for another person to take over the running of this matter because fighting entropy may be not only something that you begin to shy away from after you've been doing it for a number of years, and knowing what the fight is about, but also that you may not even recognize the ways that the corporation is failing, and it needs these younger people who have vigor of a physical kind and a vision that's complementary but perhaps expanded on yours; they need to have a chance.

Those are the things.

DR. COLE:  Thanks.

CHAIRMAN KASS:  But thank you very much for your comments.

Let me make a suggestion.  We're at the place we were scheduled to break.  We started a little late.  There's still three people in the cue.  If you don't mind, let's take the three comments and then you would respond to them in one piece, if you wouldn't mind.

I have myself, Peter, and Dan, Dan Foster.

It seems to me that, agreeing with all that Paul has said about responsibility of stepping aside and those things, the brunt of your talk really wasn't about that question as much as it was about what life should be like for people who have stepped aside and what one can reasonably expect from them.

I like very much the emphasis in the paper that authenticity and indeterminate freedom, or even the preoccupation with health, are somehow, while desirable in themselves, are insufficient because they are relatively content-free in terms of what healthy, authentic freedom should be used for, so that life is somehow fulfilling.

I mean, I'm seduced by the paper and the sort of idea of life that informs it, but — and this may be another one of these paradoxes that is simply ours to struggle with — but it seems to me in a world that's after virtue, it seems to me increasingly difficult to begin to talk about the virtues of those who are past their prime and to somehow begin to talk the language of the virtues that one should expect from them or try to cultivate them in a community in which the language of virtue has ceased to be the coin of the real, but where we talk about rights or various things of that sort.  So that would be the first point.

And that's made even worse by the fact that, in answer to Mary Ann's question and nervous about contributing to blaming the infirmed for their infirmities or trying welfare programs, you continued to emphasize the neediness rather than the aspects of the humanity of the old, other than their neediness, which is precisely the problem that we have fallen into.  I mean, to treat the elderly as either actual or soon-to-be objects of need and care is to cultivate a certain kind of condescension toward them and the community as a whole; whereas, what we really want to do is to remember the older you get, the more you realize what an injustice you have committed against the elders in previous ages, when you realize that from the inside they're still the same person they always were, at least until the very end.

So, to the extent to which we somehow think that what we have to do is promote the vision of care and the vision of neediness, we are in ways undermining the very kind of thing that you're trying to achieve here.

Lastly, it's just kind of a riff on this same point:  If, on the other hand, you are emphasizing the need to enable people to solve their own problems, to be more independent and self-sufficient, you're getting in the way of the kind of nice dialect about receiving with which the paper ended.  That is, on the one hand, you want to say to the old, "Well, don't be objects of need and care.  Be independent.  Learn to develop.  Learn to grow," and do all these sorts of things.  That makes it much more difficult to acknowledge exactly what is true of life as a whole, but especially in old age, that one of the gifts we have to those who are our descendants is we provide them with the opportunity, in fact, to care and to establish those bonds that really are enriching.

Now I don't expect you to solve those paradoxes.  I maybe simply caught the point of the talk.  But these are just things that are prompted both by the talk itself and the way in which you've proceeded to respond to previous questioners.

I then have Peter.  If it gets too much, just interrupt, but let's take Peter and then Dan, and if you can hold comment until the end.

DR. LAWLER:  Mass longevity is not so much a gift, but a deliberate project of human beings to overcome the life cycle or biological constraints.  The goal of this effort to overcome these biological constraints really is freedom from necessity, and this "freedom from" is especially enjoyed today by the old.  So the question is, what is this "freedom from" for, and the answer was given very properly by Gil.  It was for family, friends, and you added contemplation.  That makes good sense.

But the problem is the process that won us this "freedom from" is bound to be somewhat bad for families, friends, and contemplation.  This is a problem.  This is a paradox.  This is the downside of the upside of the great victory which has brought us mass longevity.

This is good to know because we can avoid this in our own cases.  During our productive years we shouldn't be so productive that we're not virtuous enough, so that when we get old, we don't have family, friends, or the ability to contemplate.

Maybe it will be proper for our Council to highlight this problem, so that many Americans can avoid this.  Nonetheless, I don't know of any government policy that could solve this problem or even alleviate the downside of mass longevity.

So it seems to me the government policies you pointed to had nothing to do with the problem you raised, which was a very good problem to raise.



DR. FOSTER:  Well, I was going to say more, but let me just say two things.  Another interesting conflict that Peter hinted at right here is that in much of the world today the essential problem is to get an aging population — if you look in southern Africa, the life expectancy because of AIDS is 40 years.  If you look in the developed countries, we may have a solution to the aged in the long run because the birth rate has gone down dramatically in the developing countries which are there.

You could solve the problem of the aging in this country if you dismantle Medicare, and so forth, because they would die.  The best health insurance in the world is to not keep people alive, you know, to do that.  So you could have a correction simply by saying, well, okay, we're not going to treat people.

But the other side of that is that where the birth rate is high and where disease is not overwhelming, most of the children are coming out of resources and out of parents who don't have the opportunities to develop in a sense.  So what is happening is — and it's, I think, happening, will happen in our country and every place where there are lot of immigrants who have come from places that they can't help, but they don't have the opportunities to do things, is that you're going to have a big increase in the population without the resources to do it.

So my only point is that in much of the world the problem is that people are dying way too early, and there's a huge moral consequence that we have treatable diseases that we can't do anything from a humanity standpoint, but if you want to solve the problem of too old a population, then you just let that go.

And I would say one other sentence and then I'm through.  Because all of you know that I work in a teaching hospital that takes care of the poor.  Much of what we've talked about today is applicable to the healthy aging, as people have talked about.  Then you might think of moral things.

Survival is what we talk about every day, just survival.  We have more re-admissions to the hospital for congestive heart failure than you should possibly have, just because the people, even with Medicare, can't get their drugs, and a huge number of persons in Dallas, Texas don't even have Medicaid or Medicare.  So you get them in the hospital, get them out of their congestive heart failure; two weeks later they're back in — survival.

I mean most of the people that I see that are aged would not understand one single word of what we're talking about here.  They're talking about mere survival, and to be a recipient and understand all the arguments for reciprocity, and so forth — anyway, there are a lot of other things I could say, but I do think it's an interesting paradox for humanity as a whole, what to do about life expectancy, whether that's a good thing or a bad thing.

I think a 40-year life expectancy, whether it's in certain neighborhoods in Washington, D.C., because of drug murders, and so forth, or anywhere else, or Dallas, or an AIDS epidemic that's out of this world — and then, of course, we also, with all the wars that are going on all over the world, we also have wiping out the elderly, too.

CHAIRMAN KASS:  Please, as you wish.

DR. COLE:  Okay.  Thanks for those questions.  I'm not sure I got precisely every point in each comment.  So maybe during lunch we can pick up some of these conversations.

DR. FOSTER:  May I interrupt to say don't comment on whatever — I don't have to have any comments on anything.

DR. COLE:  I think there were some real interesting points I would like to respond to there.

One of Leon's questions was, where does the language come from that helps us understand what life should be like for people who have stepped aside?  One of the things I need, I think we need — and, actually, there's an enormous research agenda in this area.  One of the things that the committee could do is suggest the importance of setting aside funding to study these issues because it's not there.  It's very, very hard in the National Institute on Aging for humanistic and even social science, qualitative social science projects to be funded.

I think that the language will come from the people.  The language will not be in our theoretical ideas.  I think it will be an ordinary language, which is why I think we need studies of how people construe this, even in impoverished, especially in impoverished situations.  Because the woman who comes in for congestive heart failure and keeps bouncing back in, and is only seemingly concerned about survival, when she goes back to her home, she may have grandchildren living with her.  She may be in a church environment.  She may have a world view and a world order, independent of the health care, that helps her make sense of things.

So studying the language, I mean listening to different communities of older people and how they articulate their relationships to their churches, to their families, I think we would find an enormous amount of strength, moral strength, in ordinary life and from ordinary people, which then could become raised up as exemplary.

On the question of my seeming to emphasize the neediness of dependent elders, which seems to undercut the idea of their responsibilities, I think it's very important to begin to try to think about reciprocity, the need for people who are dependent, are necessarily dependent, either on their children or people who come in for home care or in nursing schools, these people need to be needed, too.  Finding ways, however subtle, to allow these people to reciprocate, and this can happen in genuine relationships that get started — this is part of Wendy Lustbader's point in her book The Kindness of Strangers — is one answer to this, by respecting the fact that these people are not just the demented patient or COPD patient on a certain floor, but have a whole life, and it's possible for that life to become intertwined with the lives of others who might like the stories, who might like the relationships, and caregivers.

On the issue, Peter's issue of mass longevity being a goal of human effort, I think that's a good point.  That's the Baconian project.  That's clearly what modern medicine has been after.

And you're right that the downside of mass longevity is something we hadn't anticipated, just the way we didn't anticipate that, once we were able to cure infectious disease and create public health conditions that allowed people to live, so their lifespan went from, life expectancy went from 40 to 75, we didn't anticipate the emergence of chronic disease and the debilitation that would come from those added years.

I don't think that means that in either case we shouldn't embrace and look for the possibilities in those experiences, and we shouldn't shirk our responsibilities for caring for people who suffer from those conditions, but I think we should also find ways to encourage people to take care of themselves and to know that it really makes a difference.

Compliance rates for so many things among patients is notoriously low, and I know it's a continuing problem for physicians and people who work in hospitals to have people bouncing back because they're just not doing what they need to do to take care of themselves.

I don't think I have much more to say in response to Peter's comment, except I would like to learn more about it.

And the last thing is in response to Dan's comments.  My understanding is that, except for southern Africa and Russia, life expectancy is growing almost everywhere else in ways that we would not have anticipated, we would not have expected.  It represents a serious crisis because those countries, those states, in the developing world do not have welfare states in place, do not have resources set aside to care for declining elders.

A couple of years ago, I was on a committee for the U.N.'s attempt to conceptualize aging during the International Year of the Older Person.  One of the things that that committee was working on with this in mind was to reformulate the image of aging in these countries and in our own country, so that older people became understood as resources, as people with potential to give, and wouldn't be seen just as people to marginalize and set aside, because that is going to be one of the only ways that these countries are going to be able to allow their older people to flourish, is if there can be ways for people to understand and cultivate their abilities to mentor, to keep contributing, to be useful.

So that's my response.

CHAIRMAN KASS:  Thank you very much, Tom, for a very rich discussion.  You have given us lots and lots to think about.

We are about 20 minutes behind.  That means I'm going to try to hold you to a 15-minute break, and we'll reconvene at five after promptly.

Thank you.

(Whereupon, the foregoing matter went off the record at 10:48 a.m. and went back on the record at 11:10 a.m.)


CHAIRMAN KASS:  During the break, Judy Crawford has left at our place the information regarding dinner for those who are joining us.  "I" Street is one street north, and the way to get there is to walk to "I" and just head west.  We will meet there at 6:30, just in case I don't remember in the afternoon session.  The little gray cells are not what they used to be.

This second session actually will pick up on themes that were at the very end of Tom Cole's paper, where he discussed questions of independence and dependency.  It's a great pleasure for me to again welcome Carl Schneider, who brings to this subject of medical decisionmaking the perspective not just of an autonomous autonomist, but a whole career of teaching family law, among other things.  I think that and the fact that he has a kind of muscular way of thinking and writing, which I very much admire — I appreciated these papers that you sent us very much.

We've had discussions in here before about the advance directive as one way to deal with the problem of decisionmaking for those who are incapable of making decisions for themselves, and Dr. Schneider has kindly agreed to lay out for us some of the alternatives, the strengths and weaknesses, and help us advance our own thinking on this subject.

So welcome again, and the floor is yours.

PROF. SCHNEIDER:  Thank you.  It's very kind of you to have me here, particularly since you don't need me; you have Rebecca Dresser, who is as important and useful an authority on this subject as the country has to offer.  It's a particular pleasure for me to be here because I know and esteem so many of the people on the commission and their work.

Perhaps I should say a word about myself so that you will know from whence I come.  First of all, I am a lawyer, not a doctor, although I have an appointment at our medical school.  This always confuses people.  You know that I'm not a doctor because I do not have slides for you.


I work in the part of bioethics that you have generally been ignoring, and that is the part that deals with the ethics of medical decisions in various forms, the doctrine of informed consent, various sorts of attempts at advance directives, end-of-life decisionmaking generally, physician-assisted suicide; those sorts of questions are the kinds of questions that you seem to be approaching and that I have been dealing with.

I am not just a lawyer, but an empiricist.  I plan to provide you not so much with information about what I think, which should not be very interesting to you, but information about how the world works, which ought to be very interesting to you.

The kind of empirical information I will be drawing on starts with medical studies.  One of the wonderful things about doctors is they often seem to care how the world actually functions and they study it.  I have tried to read, as systematically as possible, the medical literature that deals with the ways decisions are actually made.  I've spent a good deal of time doing research among doctors and patients, observing and interviewing them.

There is another source of data that I have found that's quite wonderful.  In the United States today there is a kind of cultural taboo against being seriously ill and not writing a book about it.


There are literally hundreds of these books, and many of them are wonderful.  They are wonderful sources of information and they're wonderful stories about people.  I have consistently found both this reading and my research among patients genuinely inspiring.

I confess that I have been puzzled about how to be most useful to you.  I have assigned readings in the usual way, but I am also aware from a quarter of a century of teaching that readings are not always read.  So I could just repeat orally what I have said in writing.

Mr. Levin's letter to me was Caesarean in its ambitions.  Leon Kass' suggestions to me were equally ambitious although rather different.   I tried to find solace and guidance by reading your transcripts, and as soon as I finished one transcript, I discovered it was contradicted by the next transcript, at least insofar as it was giving me guidance about what you might be trying to attempt.

So what I have decided to try to do was to speak to you in the sadness of experience.  The sadness of experience is that your predecessors in interests, as we lawyers like to say, other commissions and bioethicists, have over the last several decades provided the country with a series of bioethical programs.  The doctrine of informed consent is certainly one, new standards for research ethics, the Patient Self Determination Act, ideas for encouraging organ donation, and the like.

It is a fair generalization that these bioethical reforms have consistently failed to achieve the ambitions that their proponents had for them — consistently failed to achieve those ambitions.

And what I want to do is to talk a little bit about what we know about how medical decisions are made, how decisions for incompetent patients are made and might be made, drawing again on the kind of empirical research that I've been describing, and to try to talk very briefly then about what lessons you might learn from the failure of your predecessors.

Everything turns on informed consent.  Everything turns on the ability of competent patients successfully to make contemporaneous medical decisions.

The evidence is that they do not make medical decisions, even after a full generation now of informed consent, in the way that the proponents of informed consent, the way that earlier presidential commissions imagined would happen.

First, doctors do not provide patients with the kind of information that bioethicists supposed they would.  One recent study suggests that only in 9 percent of the many interactions between doctor and patient that these researchers observed, only 9 percent of those cases were patients given the kind of information they would need to make an intelligent medical decision.

Second, patients do not understand and remember what they are told.  Now why this surprises people is a mystery to me because so many of us here are teachers, right, and what do we do every semester?  We read the blue books.  And what does that tell us?  It tells us that what we said so lucidly and so often was not understood, that even the work of regurgitating simple facts is not done successfully by students who are specially picked for their skill at studying the areas you are teaching.


If that is true, a fortiori, as we lawyers like to say, even more strongly must it be true that patients, a completely random sample of the population, will not fully grasp and understand what they are told and, indeed, they do not.

One of the areas where decisionmaking has been best studied and where most efforts have been made to promote good decisionmaking is in the area of the treatment of breast cancer.  One study asked women who were interested primarily, they said, in survival, what difference there was in the survival rates of the treatments they were considering, and only 40 percent of these women answered correctly.  This was after they had consulted on average 5.5 sources of information.  Worse, of the women who said that recurrence was their greatest concern in making the decision, only 20 percent correctly recited even a rough rate of recurrence.

So not enough information is given.  Not enough information is understood.

Third, these problems cannot be solved in the ways that people have imagined or in any way that I can imagine.  These problems do not exist simply because doctors don't try hard enough and patients don't try hard enough.  No amount of fiddling is going to change this.  Let me give you a few reasons.

Let me say right upfront here that I am not describing one class of patients in general and myself as a distinction.  Many of my best insights into the foolishness and incomprehension of patients' decisions come from introspection.

I recently had the gout.  I formally consulted two physicians and was informally volunteered information, including one 20-page printout from WebMD, from three other physicians.  They all had completely different suggestions to make, all in terms of complete confidence.  I read the 20-page printout.  I listened to their advice, and I still don't know what I should do.  I don't even know whose advice to follow; I respect them all.


PROF. GLENDON:  Ask Dan Foster.

PROF. SCHNEIDER:  Please don't.  Please don't.  I have reached the point of information overload on this question.


CHAIRMAN KASS:  It's not a question of information; this is accurate.


PROF. SCHNEIDER:  Ah, I'm glad to hear it.

And this isn't a particularly complicated decision.  I mean people have had gout since, we know, the 18th century.  By the way, it is not caused by drinking too much port.

Where do the problems arise then?  Some of the problems arise from the fact that the literacy of the American population is quite low.  About 45 million people, or roughly one-quarter of the American population, are functionally illiterate.  Another 50 million are only marginally literate.  This means that in one study 42 percent of the patients could not understand the directions about taking medicine on an empty stomach when they were written down.  Many patients cannot read the appointment cards that they are given.  Many patients cannot read the cards that tell them how to get to the next office down the hall.

Many intelligent people just like us have tried for many years to solve this problem by writing simpler and simpler kinds of instructions.  One recent and sophisticated attempt to do so tried to provide prostate cancer patients with information about their choices.  When this project was finished, the authors conceded that it could not be read by half the population.

I have said nothing about the problems of mathematics.  These problems are at least as severe.  One of the standard tests of your numeracy, if that is actually a word, suggests that, asked three very simple questions, only 16 percent of the population got all three answers right.  Questions like, 10 is what percent of a thousand?

This works itself out in actual medical decisions in disturbing ways.  After being given data about risk reduction from mammography, from 7 to 33 percent of the women given the information, depending on how they were given it, estimated the benefit of mammography correctly.

But let's suppose all of these problems vanished, that we have patients with perfect information and perfect understanding.  Will that solve all of the problems that patients have in making decisions?  The answer is no.

And one reason that the answer is no is because what bioethicists generally assume is that patients come to decisions with a coherent and well-worked-out set of values relevant to the questions before them.  They do not.  Most people have better things to do with their lives than working out the kinds of values that you might need for making unanticipated medical decisions or even anticipated ones.

And, in fact, what psychologists who study these things tell us is that we do not make decisions by consulting our values, reasoning from them, and then doing what the reasoning tells us.  Rather, our values tend to be explanations that we give for the decisions we make and not the motives for the decisions themselves.  This is one reason that so often people make very inconsistent kinds of choices.

But let's suppose away not just the problem of information, but also the problem of values.  Would we then make good decisions?  The answer is no again.  The answer is no again because, in order to make a good decision about the future, we have to predict how we're going to react to the possible results that we might reach in the future.

And there is a very interesting body of research that psychologists gracelessly call hedonic forecasting.  Are people able to predict what is going to make them happy?  Well, now you would think that nothing would be more important to human beings than thinking about and being able to predict what's going to make them happy in the future.  People are spectacularly bad at it.

People grossly overestimate, for example, the intensity of emotions they will feel in the future and, not least, the duration of emotions that they will feel in the future.  This is why, when you've spent all of that money to buy an Audi, it did not give you $59,000 worth of satisfaction.  The satisfaction peaks the moment you drive out of the showroom and declines very precipitously thereafter, just like the price.  And there's a reason that the price goes down that fast.

Furthermore, people make these mistakes in ways that are especially relevant to medical decisions.  There are some interesting studies, for example, of people who recently have become quadriplegic or paraplegic.  They tend to picture for themselves a very, very bleak future, and, indeed, some people are suicidal, have some suicidal thoughts on receipt of the information.

That is because, among other things, what they are doing is they are saying, here is a datum; I am paralyzed.  How is that fact going to make my life worse?  What they do not say to themselves is, what are all of the things in life that I value and that give me satisfaction, and which of those things will I still be able to do, and how will my psychological immune system try to create ways in which I can be happy even given this fact?

And there was a famous study which very roughly goes like this:  You take people who have recently become lottery winners and people who have recently become paralyzed.  The lottery winners' happiness shoots up precipitously; the paralyzed people's happiness shoots down precipitously.  After a year, they have essentially returned to what some psychologists think of as their happiness setpoints.

But nobody thinks that that's what he's going to do when these things happen.  People do not predict their own future happiness very accurately.

Now part of what's going on here is that, in fact, it's true that experience is in many ways the best teacher, and experience often counsels us to reconsider our opinions.  People these days routinely recite the mantra that the quality of life is more important than the quantity of life, and they believe it up to the point at which the quantity of life actually becomes an issue, at which point they become remarkably unwilling to give up increments of quantity in order to get fairly large increments of quality.  There are some very interesting studies of this.  People who are very ill think that their lives are much more satisfactory than observers of their lives think.

There's a wonderful book by Wilfrid Sheed on his experience with depression and cancer and polio, and I think drug addiction.  He said he quickly learned that cancer, even more than polio, has a disarming way of bargaining downward, beginning with your whole estate, and then letting you keep the game warden's cottage or the badminton court, and by the time that it has frightened you to death and threatened to take away your very existence, you would be amazed at how little you're willing to settle for.

This is true, but when people are making decisions, this is not what they imagine themselves thinking.  But let's suppose all of these problems of information and values and psychological insight, let's suppose those problems all away.  Then can patients make good decisions?  And the answer is, you'll be surprised to hear, still no, and that is because people then have to go through quite an arduous process of reasoning about which means will best serve their ends.

That is something that people seem not to do very well.  There are many reasons for this.  One of them is that we all, in thinking about all kinds of problems, rely on what psychologists like to call various kinds of heuristics, shortcuts in our thinking that make reasoning easier for us.  These shortcuts actually turn out to work pretty well in situations with which we are familiar, but when we move into unfamiliar territory, these heuristics often serve us very badly.

We have a tendency, for example, to interpret all data as confirming our earlier opinions.  There are fascinating studies of people listening to presidential debates, and they invariably conclude that the debate confirmed the wisdom of their earlier opinions and the choice of candidate on the substantive issues.

People have a very hard time in keeping vivid information from completely overwhelming dry information, which is why stories about "my aunt who had this problem" invariably overwhelm more systematic and reliable statistics

But the problem is not these rather mechanical kind of heuristics alone.  Let me tell you about a study in which I briefly participated or in which I participated but in which somebody else did an awful lot of the work.

A physician and I went around to randomly-selected males in Ann Arbor and we said, "Doctors can't decide whether you ought to be screened for prostate cancer.  So what they have done is to defer the decision to you.  You're supposed to decide whether you want to be screened.  Here are all the data that you need in order to decide whether you should be screened, and we were willing to spend as much as an hour and a half talking with these men about whether they wanted to be PSA screened or not, leaving quite aside the question of just how many physicians in this world are going to have the time to spend an hour and a half chatting with the patient about PSA screening.

We worked very hard to be sure that we had solved the information problem, and then we would say, "So do you want to be screened?"  And they would say yes or no.  Either answer, of course, is acceptable.

But then we would say, "Why do you want to be screened?"  And he would say, "Well, I believe that prevention is always better than trying to cure something, and so I want to be screened."  Now it is true that it is better to prevent a disease than to try to treat it, by and large, but it is not true that PSA screening prevents diseases.

The difficulty here was that they were really latching onto an important idea that did apply to cancer in many sorts of circumstances, just not this one.  But we would never have found out that they didn't understand that they were using a wrong heuristic had we not been doing research and had the time to schmooze with them about the nature of their reasoning.

But this was a situation where people went through their reasoning fairly carefully.  What I have learned from the studies is that, by and large, people tend to make medical decisions with an alacrity that precludes thought.


It is literally true that people make decisions on the spot a very high percentage of the time.  I have observed people being given choices about modality of dialysis at some length, and this is a caricature but captures the truth.  The informer would start, "We're very sorry to have to tell you, but your kidneys are failing and you're going to need some kind of substitute for them.  We have a couple of things to offer you."

Their first thing is called hemodialysis.  Now with hemodialysis, we take two large needles, at which point the patient says, "Needles?  I'll take the other one.  What is that?"


But sometimes they would listen placidly through the needles part and would get to the part where we started to talk about peritoneal dialysis which involves implanting a tube.  "Implanting a tube," they said, "would it show in the summer when I was wearing a bathing suit," or I suppose these days when you were just wearing clothes.


And the physician would say, "Well, yes, it will."  "I'll take the other one.  What was that other one?  Oh, yes, the one with the needles, I'll take that."

Now this is, first of all, happening at a speed that makes it clear that people have not really assimilated and thought about all the information that may be relevant.  In fact, one of the questions that people never asked and were never provided was data on the relative morbidity and mortality of the different kinds of dialysis.

Now what is clear is that a significant number of the people who make decisions are fastening onto a single factor and making that the sole basis for their decision.  Sometimes that's not a bad thing to do, but with difficult medical decisions this is often a reckless way of going about making decisions.

Another way that we know something about the process that people go through in making medical decisions is that, when we ask the people who write the kinds of books I've been describing, first of all, they almost never describe making medical decisions.  I started reading these books in the hopes of writing a book on how people made medical decisions, and I couldn't do it because the data did not permit me to talk about that.

When they did talk about it, they talked about it in terms like this:  "I've learned to listen to my inner voice for guidance when choosing treatments.  If I get a ding" — parentheses, a strong instinct — "about a vitamin, herb, drug, or other treatment, I try it."

Lest you think that this person was not one of us, a sociologist at Rice describes his experience with prostate cancer, an experience that he found in some ways an enlivening one because he said the research was so interesting that he forgot why he was doing it.


But when it actually came to choosing what kind of treatment he was going to have, he realized that he had made a decision during a conversation with the surgeon.  He did not realize why he had made the decision.  He was not aware of having made the decision.  It was something that he discovered that he had done.

Let me say one last thing about patients and contemporaneous medical decisions.  Many patients do not want to make medical decisions.  That is a fact.  That is one of the most carefully-studied facts in the area that I am describing.

And lest you think it is because they are anxious about their ignorance, the rates at which physicians say they want to make their own medical decisions are approximately those of the rates at which laymen say they want to make their own medical decisions.  Now there are many reasons for this, and the book that I assigned a little section from talks about them at great length.

But if nothing else, it is going to be hard to get patients to make good decisions when they don't want to make decisions at all.

Now, I'm sorry, Leon, when did I start?

CHAIRMAN KASS:  Why don't we say at 11:15?

PROF. SCHNEIDER:  Okay, I will try to stay within the various promises I have made about how long I would talk.

So incompetent patients, what to do about them.  Well, to your predecessors in interest, the answer was clear.  If people are not going to be able to make their own decisions at some point, then you should ask them in advance what decisions they want to have and have them write that down, and then you will know.  And there are still many people who deeply believe this.

I assigned the article that Angela Fagerlin and I wrote about living wills.  I will not dwell on this subject at length, but I can tell you that the editor of the Hastings Center Report tells me that he has never gotten more responses to any article they have ever published than that one, and, believe me, there are many people who are deeply angry at me.

Just before I left Ann Arbor, I got a letter from a physician who said, "You have destroyed my reputation in my community.  I have been arguing in favor of living wills for all these years, and how do you explain the Schiavo case if what you said is true?"  This is a virtually verbatim quotation from the email message I got.

So I'm not jousting at a strawman, if that's not a terribly mixed metaphor, when I tell you that this is a subject about which there are still lively differences of opinions.

Now, essentially, much of my argument about why living wills do not work and cannot be made to work is, again, an a fortiori argument from the situation I've just described as contemporaneous medical decisions.  Essentially, if people don't make very good medical decisions contemporaneously, it is not reasonable to expect that they're going to make very good medical decisions about a situation they have not experienced from among many situations that they might encounter using treatments that they don't know anything about.  And, in fact, the problem of speculative decisions is one that many patients themselves are well aware of.

Not least, too, are the informational problems.  One of the things that I have to say disturbs me most about the enthusiasm for living wills is that everything that autonomists, bioethicists, and presidential commissions say about the importance of informed consent evaporates when they begin to talk about advance directives.  People write advance directives with literally no information at all, and they live in a miasma of misinformation.

People believe, for example, that CPR works as often in life as it does on ER.


And I'm not making this up.  There are studies both of how often CPR works on ER — a lot of the time most of the people who get it are quite young and don't have heart problems particularly, and there are a lot of studies about how much people know about CPR.  When you tell people what CPR actually does and how well it works, people's enthusiasm for it plummets.

But people who write advance directives, whether they are administered by doctors or by lawyers or by the many websites that are available to you, or my mother's technique which was, after listening to one of my colleagues talk about the Cruzan case on television, she sends me, of course, regularly a packet of clippings that I ought to be interested in.  Affixed to one of them was a large post-it note that she had written in pencil.  My mother has a Ph.D. in English literature; she is not an uneducated person and she's very bright.

She writes, "To whom it may concern:" on this post-it in pencil.  "I do not wish to be treated by heroic means or extraordinary measures.  Sincerely yours, Dorothy Schneider."

All of these people, even with the most expert help, do not have the kind of information they need to make a decision in any way that a bioethicist would recognize.

The other problems of living wills I've already discussed at length in the article and will not repeat.

The bottom line that I think is often not paid as much attention to as should be is that the evidence we have is that, by and large, advance directives do not affect patient care.  In other words, whether they should work or not, they don't.

So if living wills don't work, what, then, for incompetent patients?  And this topic has been discussed largely in terms of what standards we ought to use when surrogates make decisions for incompetent patients.  Of course, the two standards are what is very oddly called substituted judgment, which means trying to do what the patient would have done, and the best interest standard, which means trying to do what you think would be best for the patient.  Those are the two standards.

I will not discuss the best interest standard because there is nobody in the country who has written more about it and better about it than Rebecca has, and I believe you're discussing it this afternoon anyway.

Let me talk about the subjective judgment standard — I'm sorry, the substituted judgment standard.  It asks the impossible.  It asks you to read patients' minds.  You cannot read patients' minds.

Because my time is drawing short, because there are many objections I know you will have that I am anxious to explain away, let me just say that this is another a fortiori argument.  If patients do not make decisions with full information, do not have coherent sets of values that they reason from, do not predict their preferences very accurately, do not spend much time reasoning about things, and reason in ways that look close to arbitrary and trivial part of the time, it is not going to be possible for surrogates to try to replicate the process of reasoning that a patient would have gone through to make a decision.  It is in that sense that I mean that the surrogate cannot read the patient's mind.  Indeed, as I've tried to suggest, the patient himself often has trouble reading the patient's mind.

What we do know about the attempts to have surrogates read patients' minds is very disturbing.  I've already told you that observers are not very good at describing how happy patients are in their current medical situation.  By the way, families are a little better than chance.  This is very crude but basically true.  Doctors operate at about the level of a coin flip in understanding how their patients perceived their current situation.

Once again, these are not trivial problems that can be solved by better education.  Many problems cannot be solved by better education, and this is not one that can be.

There is a very interesting study in which the surrogates were people who had known the patient on average for 40 years.  They were mostly spouses of elderly people.  They were asked to describe how the patient would wish to be treated, how the patient would forecast he would wish to be treated in a series of hypothetical situations.

The surrogates who had known the patient for over 40 years were right at a level a little better than chance.  So then you said, "Let them read the living will that these people have drafted and that will solve the problem."  The meter did not budge.  The predictions were no more accurate.

Then they said, "Well" — this is what many doctors recommend — "just talk to your family about what you want and then they'll be able to do it."  So they had the spouses sit down and talk about these things and to discuss the living will as a conversation starter.  Once again, the meter did not budge.  Accuracy of prediction did not increase.

Now let me say very briefly here that in some ways the discussion about what the standard of decision for the surrogate to use should be is not a discussion that will produce changes in the world.  The reason it won't produce changes in the world, at least in any very direct way, is that — and here I'm speaking as a lawyer — the law is very poorly situated to affect the way these decisions are made.  The law doesn't have a point of entry into these decisions.  These decisions are made in private.  They are made by people who do not wish to be supervised by the law and who won't tell the law what's going on, by and large.

They are decisions which can be evaluated in terms of whether the standards were properly applied only by describing the reasoning that was gone through.  However, both of these standards are sufficiently indeterminate that you can justify almost any generally plausible result under either theory.  In fact, the two theories often collapse into each other.

Furthermore, if there's one thing that's true about courts, they do not want to take jurisdiction over these questions, and they have repeatedly rejected opportunities to supervise this process.

Now where does that leave us?  Well, in the law what we do if substantive standards can't be found to resolve a question is we say, let us try to find some procedure that we can use that will tend to produce generally-satisfactory results in as many cases as possible.  When substance fails, we look to procedure.  That is one technique we can use.

Another technique we could use, and this is one that bioethicists and presidential commissions rarely use, but seems to me to be quite sensible, which is to ask patients in general how they would like things to be solved.  We spend a lot of time talking about autonomy, but we always tell people what kind of autonomy they should want and how they should want to use it.

If you go around and ask human beings how they want these decisions to be made, they do not tell you that what they want is autonomy, and they don't even feel in anything like the way that you would suppose that what's important is the decision they would have made.  In fact, there are a couple of very interesting studies in which patients are told, "Imagine you have the ideal living will that perfectly expresses your preferences, and suppose that some person appointed by the law were your surrogate, not necessarily the person you would have chosen, but the person appointed by the law to be your surrogate, and the surrogate wants to do something different.  Would you object?"  And 54 percent of the people said that, even in that situation, they would not object, that they would want their decision to be overridden, not least because they say, "Well, how do I know what's going to happen?  They're there."

Furthermore, patients want not just a reasonable decision based on the current facts; they also want a decision made by people they love and by people who love them.  This is very important to them.

And part of the reason it's very important to them, of course, is because patients are non-autonomous in another sense.  When courts talk and bioethicists talk about autonomy, what they tend to talk about are the interests of the patients.  What patients tend to talk about are the interests of their families.  Patients are, obviously, very concerned with how the decisions that are made for them will affect their families, and that's one reason that they want their families to be involved in these decisions.

So if we ask patients what they want, we get an answer that is much more tolerant of a best interest kind of decision as long as it is made by the right kinds of people, made, in other words, by their families.

Now what about the lawyer's response trying to find a process?  Well, lawyers will instantly begin to think about formal processes and that leads to talk about due process and that leads to misery.

But lawyers think a lot about informal process, and what lawyers essentially imagine is a process in which the family and the doctors negotiate, exchange information and opinions, and reach a process of consensus.  That is what I would suggest to you would be an informal process that would be as likely as any other process that one can reasonably imagine and pay for to reach relatively decent decisions.

And, in fact, there are studies of how these decisions are actually made today.  What they suggest is exactly what I have described, that there is this process in which the patient is failing, and somebody raises the possibility not of, as it is vulgarly put, pulling the plug, but of beginning to pull back on treatments, of not pressing as hard as you were, by gradually withdrawing particular kinds of treatments.

These studies suggest that over the space of a very short time, for most patients as little as 24 hours, that decision is made.  Now the interesting question, of course, is whether these are good decisions, and, of course, the problem is we have no way of evaluating the decisions because we don't know what good is.

But when you ask the families who went through this process whether they are contented with the decisions that they have made, the answer is yes.  They were not happy with the decision because the decision is an unhappy decision, but they felt that they had gone through a useful process; they had tried to do the best; they had tried to do everything they could for the patient and to get as much information as they could, and that they had reached a decision which they could live with.

What they're unhappy about is what bioethicists tend not to care about.  It's much more commonplace and quotidian kinds of things.  Oddly enough, that's what competent patients making contemporary decisions care about much more than their autonomy.

They want, of course, competent medical care.  They also want to be treated kindly, solicitously.  That is what they often feel they don't get, and that's what wounds them much more than the kinds of denials of autonomy that bioethicists find themselves concerned with.

What worries the families is that they are not adequately kept involved day to day as decisions are actually — or as the patient's situation changes.  They have a hard time getting ahold of doctors, and you have these pitiable stories of wives afraid to go to the bathroom because, if they leave their husband's side for two minutes, the doctor may come and go, and they won't have a chance to talk with him for another 24 hours.

This is the kind of real medical situation that could actually be solved by human intervention and ingenuity in a way that the other kinds of problems I'm describing cannot, and solving those sorts of problems would have much more to do with increasing human happiness than one more test for how incompetent patients ought to be treated.

I don't want you to think that I am abandoning autonomy.  Obviously, there are real reasons that we want people to be able to make decisions for themselves.  I would even argue that the process I have described in which surrogates make decisions for you, in following their best sense of what would be good for you, that that process is not one that necessarily offends sensible ideas about autonomy.

Speaking once again as a lawyer, people appoint agents to work for them all the time on the understanding that the agents are going to use their own best judgment and not the person's.  That is why I do not manage my own investments; I hire mutual funds to operate them.

We regularly hire people to work for us.  In fact, there is a quite respectable theory of political representation that says the job of a representative is not to do exactly what he is told, but rather to exercise his judgment on your behalf.  It is associated with Edmund Burke, of course, and he famously wrote to the people who had elected him, "Your representative owes you not his industry only, but his judgment and he betrays it instead of serving you if he sacrifices it to your opinion."

Now I've taken up more time than I expected to, and I've learned the best way not to go over your allotted time is simply to stop.  I will do that after saying one more thing that I did promise to say, and that's to talk very briefly about why your predecessors in interest, why so many bioethicists have produced so many programs that work so very badly.

I think there are many answers, all of which I will be happy to supply you with, but two I would like to leave you with.  The first is that they were in the grip of an ideology so strong to which they were so deeply wedded, which worked in such absolutist terms that it was all they could think about; their allegiance to the principle of autonomy was so great that it was all they could think about.

Second, as Clark Gable said as he walked out the door, "Frankly, my dear, I don't give a damn," was pretty much the attitude of these entities, commissions and bioethicists, to empirical questions, to the way world works.  They did not actually stop to think about whether what they were producing was going to produce the kinds of changes in the world that they wanted.

They did not ask, ever, whether patients wanted to be made autonomous in the ways that the bioethicists proposed to make them autonomous.  They did not ask how people actually go about making decisions.  They did not ask why things are the way they are.  Things are the way they are not necessarily for good reasons, but usually for real reasons.  If you want to change the world, you have to ask why it operates the way that it does.

They believed that their principle could produce programs that would work, and they were wrong.


CHAIRMAN KASS:  This was, to say the least, not a disappointment in expectations.  Thank you very, very much for the lovely talk, very stimulating.

Jim Wilson, who is the Council's self-appointed most empirical member, has the floor.

PROF. WILSON:  I appreciate, Carl, in your wonderful testimony you have limited your comments to lawyer and physicians and did not include economists, all of whom have said there would be serious agency problems such that the family wishing to inherit the ill person's inheritance would vote for a preemptive withholding of care.  The economists get this wrong, as they get many other things wrong.

I, like everyone in this room, or I assume most people in this room, had to participate personally in the kind of decision you discuss.  My sister and I, talking with our doctor about my mother, in 24 hours we made a decision.  It was a sad decision.  We believed it was a necessary decision, and in a day or two she was dead.  This is not an unusual phenomenon.

How would you distinguish the process that you have proposed, and in which I have engaged, from the kinds of assisted-suicide laws that now appear to be on the books in the Netherlands and Oregon in which something similar, though not, I think, quite identical to what you describe is done, and it has led to deep criticism for euthanasia, as sometimes used with respect to the Netherlands?

PROF. SCHNEIDER:  Well, let me say several things.  First of all, I'm delighted to take this opportunity to acknowledge that some of my allegiance to empiricism came from having been a student in Professor Wilson's class on bureaucracy more decades ago than either one of us wants to admit.

In fact, it was my recollections of that very class that urged me, that led me to think quite often both in the book that I wrote on autonomy that I assigned part of and in preparing for today, that instead of talking once again about advance directives, that you might be better employed if you spent your time thinking about what is really one of the things that's really changing the situation of American patients and of American medical ethics and bioethics, which is that patients and doctors and bioethicists increasingly live in a bureaucratic environment that shapes their lives in ways that are often very painful and that we do not think very much about.

Let me say, second, that the law has not known what to do with what you and I have been talking about, with the realization that what most people want is for the family to make their decision; that what most families want is to be able to make the decision, and that there are special reasons for thinking the family might make a good decision and wanting to make the decision even if we're not so confident that it's going to make a wonderful decision.

The law has been torn in ways that the law can't resolve, partly, of course, because the law isn't the law; the law, as Mary Ann would remind me, if I did not say, in the United States comes from well over 50 jurisdictions, and it comes from many institutions within each jurisdiction that produce different sorts of results.

But even the United States Supreme Court can't decide whether the family is endowed with virtually holy powers over its members or whether the family is the worst thing that any member ever encountered.  You have some very strange opinions in — let me take some state court examples.

You have these tragic situations in which adult schizophrenics are being cared for by their families, and they go to the court and they say, "Our son does not want to take anti-psychotic medication.  We believe that would be in his interest."

And the court says, "So you want to be appointed his guardian.  You may be appointed his guardian, but we're not going to make you his guardian to make medical decisions for him because we don't trust you to do it, because your interests are different from his, and this is a decision that should be made only with his interest in mind."  And by that, they mean his interest as opposed to the family's.  They look at it with deep skepticism.

Similarly, there are some very interesting cases in which families come to a court and they say, "We want your permission to allow or to require or to have one of our children donate a kidney to another child."  And some of the courts say, no, that is a decision that no family should ever be allowed to make because of this kind of conflict of interest that families have.

So you have Parham v. J.R. on one hand, in which the United States Supreme Court says, of course, parents should make medical decisions for their children; that is part of the holy right of being a parent.  At the same time, you have this kind of hostility.

And, of course, both attitudes have real basis both in law and in policy.  There are good reasons for both.

What you have to do here is something the courts cannot do, particularly when they are deciding constitutional cases, and that is to say, "We have to choose a public policy that is not ideal because there is no ideal public policy.  We have to choose a public policy that will produce good results as much of the time as can be arranged."  And that means we're going to have to tolerate some bad decisions.  That is something that people are very unwilling to do because the bad decision looks so horrible, but any system will produce bad decisions.

Now assisted suicides, euthanasia, the answer is, yes, that is, that it's not so clear that the process I'm describing is so different from what is tolerated in those circumstances, and the reasons that I distinguish between the two, I think that legalizing assisted suicide is a mistake, has to do with the need to draw an arbitrary line someplace between always treat all the time in every way and the increasingly anarchic rule that a place like Holland seems to have.

So I think that what we do is to draw a line, which may not make entire logical sense, between allowing people to be fairly free about withdrawing care but not letting the same people reach a decision with the same effect if it involves something that looks to us more deliberate.

PROF. WILSON:  Can I just modify?  It seems to me, from the little I know about the Netherlands law, that one of its consequences is to draw the line in a way that favors the doctors more than the families.  Now I may be in error in that judgment.  People dispute what's going on there.

But if it draws a line in a way that favors doctors more than families, it has made, to me, a grievous mistake because it misjudges and I think weakens a doctor's obligation, first and foremost, to heal the patient.  If it draws the line in a way that simply says the doctor may participate in a conversation with family members and give such advice as he may have, then that would be a different matter.

Do you happen to know how that line is drawn in the Netherlands?

PROF. SCHNEIDER:  I don't know what's happening in the Netherlands because the evidence is so very difficult to get.  When I have spoken with Dutch physicians and bioethicists about this, they become easily angered at the suggestion that anything is happening in Holland that should not be.

On the other hand, there are people who believe with a crusader's zeal that what is happening is simple butchery, and the anecdotes are very disturbing, like physicians deciding unilaterally that a nun ought to be euthanized because the only objection she had to being euthanized was a religious one, and that if she had been thinking more realistically without the influence of religion, she would have reached a different conclusion.  You know, these sorts of anecdotes, of course, are not a basis for — and we don't even know if they're true.

I would say that you point to, obviously, one of the dangers of the proposal, which is that bad decisions will be made, particularly bad decisions to withdraw treatment too early.  The one thing I would say is that it is, as you know, a mistake to suppose that the only agency of social regulation is the law.  These are not decisions that are made in a culturally-free way or in an institutionally-free way.  It is open to the physician and it is open to the family to object to a decision not to treat.  Conventionally, those decisions can be taken to ethics committees, and, in fact, they can be taken to courts, and sometimes they are.

CHAIRMAN KASS:  Could I follow up, with your permission, Gil?

In the presentation, which also prompted Jim's question, you talked, you highlighted those circumstances where the patient is failing and we're really talking about acutely end-of-life decisions, and that's, I think, why the question of assisted suicide sort of hovers over that discussion.

But in the previous meetings of this Council in this area, we have spent a lot of time talking about the questions of medical decisionmaking for incompetent patients who are not immediately dying, and the classic problem is the problem of people with Alzheimer's Disease in various stages, where the question is not, well, should you begin to draw back from things that you're doing because the end seems imminent, but how should you decide about how to treat various kinds of eruptions and supervene on this illness at various different stages?  In fact, we're going to get into the discussion of that this afternoon with the help of Rebecca's words, if not her presence.

So I wonder whether you would be prepared to generalize the advice that you've given; namely, with respect to procedures, some kind of consultative process, family-central in a way of the loved ones with the responsibility to help decide, participation of the patient if and when possible, participation of the physician and the like. Is that true?  The first point. And, second, do you have any intuitions on the substantive questions?  Or, maybe to put it another way, are there boundary conditions that you would place on the discretion of the family decisionmakers where the question is not, "Shall it be these 24 hours or 48 hours or another week?"

I'm not sure I said that very well, but two questions:  one about the process generalized when you don't face an immediate end-of-life question, and, second, do you have any sort of substantive comments about the kind of discretion that families should have?  Would this Council be well advised to consider setting some limits or trying to articulate some limits or is this really a question of you simply have to judge to prudence, to loving prudence, on the spot?

PROF. SCHNEIDER:  It seems to me that what I have said about, as you correctly point out, end-of-life decisions applies to more ordinary, more prolonged kinds of situations.  At least important differences do not occur to me.  In fact, part of what I'm trying to do is to allow for a broader range of interests to be accommodated than are accommodated when you start setting standards.

It is one of the mysteries of bioethics why the patient's interests are the only interests that are supposed to be taken into account in making medical decisions when there are so many other people who are at interest.  Here, of course, the kind of situation you're hypothesizing is one where, by and large, families have been spending a lot of time taking care of the patient and have genuine interests that cannot be accommodated by the law and by legal standards and by formal standards, but that can be accommodated by more informal processes.

Should the law set some sort of outer limits?  Well, of course, the law does set some —

CHAIRMAN KASS:  Excuse me.  Not necessarily the law —

PROF. SCHNEIDER:  Fair enough.

CHAIRMAN KASS:   — because our audience here might be best practices committees that are fashioned or —

PROF. SCHNEIDER:  Fair enough.

CHAIRMAN KASS:  — or the community.  It wasn't simply a question of legislation.

PROF. SCHNEIDER:  Should formal standards somehow be set?  I agree with what Rebecca says about the desirability of looking at patients' best interests all along the line and using the best interest standard instead of trying to go through the fiction of substituted judgment, because I think it allows you to get around the kinds of problems of faulty decisionmaking that I have described and because, well, of all the reasons that Rebecca says, and because I agree with all of those.

Obviously, there are limits and the law does set some limits that you can't kill people.  There are those sorts of constraints, and there are the kinds of informal limits of what people will tolerate and what they'll object to and when they'll fight that are set up.

I have to say I can't imagine how you can usefully write a set of standards that will apply very well here, partly for the kinds of reasons I was suggesting beforehand.  You really have to know what the range of situations is, and you don't.

So quite apart from the difficulty of generalizing, you've got to have more data than you've got.  What I would do at this point is what the lawyer in me suggests, which is to rely on a more common-law process.

Things have moved very fast in this area.  Standards have changed very quickly.  It's not as though people aren't thinking about this and aren't responding.

I would, in the absence of information that some things are going seriously wrong more frequently than is tolerable, I would wait to see how standards develop informally and what kinds of situations recur and what sorts of rules seem to be working out well.

CHAIRMAN KASS:  Gil Meilaender.

PROF. MEILAENDER:  There was so much that seems to me wise in what you said, and so in a way I would like to just leave it alone, but I wonder if I can just press you to comment on a couple of different things.  They cut in different ways.  They don't cut in just one way.

First of all, you said one of the reasons you thought that bioethics and predecessor commissions, and so forth, have gone wrong here is that they were in the grip of an ideology about autonomy, and I do not disagree with that.  I agree with it, in fact.

But one might argue that the ideology was necessary in the face of kind of a long tradition of medical paternalism, and so forth.  I mean that's sort of a standard answer.

I just wonder, I would be interested to know whether you think there's anything to that standard answer, and that in a way that was a correction to which you're now providing a correction, and so forth.  That's one kind of question.

The other one in a way is related to these previous questions about boundaries and standards.  Just, again, not so much asking you to develop a whole set of standards, I take what you say about the difficulty of that.  I'm just curious to know what you would say about a few sorts of cases in terms of whether we can set standards.

For instance, the kinds of cases of which there have been several over the years of children born who will be, at least to some degree, retarded who are in need of immediate surgery, which we would probably give to any non-retarded child, whether any sort of standards there, whether that's sort of a bosom-of-the-family decision in your mind.

Or the case of parents who would like to have an older retarded child sterilized, for instance.  I took your discussion of the schizophrenia example to be rather sympathetic to the parents, and surely the sterilization cases are every bit as complicated in some cases for the family in terms of what they have to deal with, but it's a different kind of issue.

And without developing a code or anything, I would just be curious to know kind of how you think about cases like that.

PROF. SCHNEIDER:  The first question is about whether the strong version of autonomy was a necessary corrective to medical imperialism.  First, I think that the strong version of autonomy actually served a variety of implicit purposes, but did so by indirection and very clumsily and in ways people didn't fully appreciate.

One of the reasons that you see a lot of the literature that you see about autonomy and end-of-life decisions is because people were implicitly assuming that doctors were crazed to keep metabolic function going, that they protracted life too much.  You see that in discussions of the living will where the assumption is the living will is going to say:  Don't treat me.

In fact, one of the scary experiences I have once a year, I teach fourth year medical students.  That's fun.  I enjoy them.  They're very bright, and I like them.  But the first day I always use a case in which a patient comes into the hospital with a living will and she has unhappy things happening to her, and I say, "So do we treat this nice lady?"  And they say no.

And I say, "Why?"  And they say, "Well, she has a living will."

And I say, "What does it say?"  And they say, "Well, she has a living will.  You don't treat her."

This is one of the many reasons I don't have a living will.


Doctors cannot be persuaded to read them.  Nurses don't read them, either.  They think they're a DNR order.

Now what's happened, it's not clear that doctors really were that mad to keep people indefinitely alive in the first place.  It is increasingly plain that that is far less true than it once was.  I'm not saying that there are not still lots of doctors who may do that, but if you look at the data, they suggest that doctors' attitudes have changed a lot on this question.

When I hang around ICU units, what I see in my teaching hospital, what I see is the attending teaching interns and residents to begin hanging crepe, to begin talking about the limits of what medicine can do, and teaching the doctors to initiate the discussion of stopping treatment.

So one of the problems with the whole autonomy device is that it has incorporated these kinds of implicit, substantive goals that are thought to be promoted by this strong version of autonomy.

Mastectomies, Jay Katz' book on The Silent World of Doctor and Patient essentially says, and it's a wonderful book that you should all read if you haven't, essentially says one reason we want patients to have autonomy is because doctors were performing too many mastectomies.

So I think a lot goes on in the way of attempts to change particular aspects of medicine that seem to be promoted by promoting a strong version of autonomy.  I think that one thing that it would be wise to do is to try to check up on what sorts of assumptions you're making about what is actually happening and what effect a stronger version of autonomy might have.

The other thing I want to say about that is it is wrong to think that doctors, and anybody else, will only change their behavior if the law tells them to or if bioethics tells them to.  People are all, we're all affected by the stronger movements in our culture, and one of those movements is you don't make decisions for other people.  In fact, one of them is it's wrong of other people to ask me to make decisions for them.

Doctors, I think, insofar as they've changed their behavior, have done it for lots of reasons that would have applied even had there been no exaggerated version of autonomism.

The second question was about whether there aren't situations in which I would begin to draw lines.  The answer is yes, but not a priori.  If I were you, I would not set out to say where should the lines be drawn.

I think that the situations that you have described are exactly the kinds of situations where you should proceed cautiously and incrementally in the common-law way that I've described, and when one of these cases actually arrives, you can look at it in some of its actual facts and make a more intelligent decision than you can make by reasoning about it.

I would be inclined to want to intervene in your first case and not in your second case.

CHAIRMAN KASS:  Gil, do you want to follow up?

Well, let me pursue this last as well.  Again, I don't want to steal a march on this afternoon's discussion, but precisely because people, the culture believes that we should make our own decisions and that it would be wrong, many people believe it would be wrong to place such burdens on others, and we have had a discussion of a paper of Gil's at a previous meeting on this subject, there is a certain kind of pretense that there aren't substantive considerations that actually enter into either the substituted judgment or to the best interest standards when applied.

It seems to me one of the concerns is we have in a way, we have, I suppose — I was going to propose two polar choices, and I think you're probably suggesting that there really is a third.  But what I was starting to say was that you've got two choices.  You can either pretend that the situation is good if the process is good and we don't pay attention to the substance.  If everybody is sort of comfortable, we've gone through this, that that's the best to hope for, and we kid ourselves in thinking that due process is right conduct in these matters.

The alternative is to make explicit the fact that there are, in fact, substantive decisions that are being made about when a life is or is not worth living, and that perhaps less mischief were done if we sort of owned up to that fact, and then tried to set certain kinds of boundary conditions that would hem in discretion not only against undertreatment, but also against certain kinds of overtreatment and, of course, against deliberate killing.

So I think maybe you're suggesting that we recognize that best interest standards should operate; they are least dangerous when nobody tells you what they should be, and you allow the people on the spot to conscientiously worry this through, providing you might say, well, no direct killing, but after that who's to say?

PROF. SCHNEIDER:  No.  No, that's not exactly what I'm saying.  I'm saying that you may very well, as you begin to see cases in which rather mildly retarded people, children, are being allowed to die when everybody else would be allowed to live — in fact, those are cases where there are actually legal rules — that as those develop, that then you say this far and no further, but you don't try to sit down in advance and imagine what circumstances you would permit and what circumstances you wouldn't permit, partly because I think these cases are, as lawyers say, very fact-intensive; that they will look very different depending on rather mild changes in a whole lot of different factors.

It's the same problem as the problem of the planned economy; you just can't anticipate all of those things in advance.

CHAIRMAN KASS:  Dan and then Paul

DR. FOSTER:  I can't speak for all doctors at all in these issues, and I know a lot of doctors, but one of the things that has not come up here in this concern about doctors and patients and families making decisions is this:  that very often, when a serious illness comes up and there are options, whether it's prostate carcinoma or something, almost always the family in loving asks me this question:  What would you do if this was your mother?  Or what would you do if this was your son?  Or what would you do if this was your wife?

In other words, there is a conscious appeal — if they trust the physician, then they want to hear from somebody who is presumably reasonably knowledgeable about this, about what you would do.  Sometimes decisions are very hard to make, but they always want, it seems to me they want to ask.

I think I cited this paper sometime in the past.  I can't remember whether I did.  But there's a most famous paper written by the late Franz —

PROF. SCHNEIDER:  Franz Ingelfinger.

DR. FOSTER:  — Ingelfinger called "Arrogance."


DR. FOSTER:  And you will remember that he, who had worked all his life on the esophagus, got an esophageal carcinoma, and he was the editor of The New England Journal of Medicine.  As a consequence, he was probably the best known person in the world since this was the most widely read journal in all the world.  And when his diagnosis was made known, he was just drowned in opinions from doctors all over the world about what he should do for therapy.  His children were doctors also, and he described his anxiety about trying to decide radiation or surgery first, or whatever.

Finally, somebody said to him, "Franz, what you need is a doctor."  And he said he followed that advice and got an internist that he trusted and he said, "I'm going to do what you think is best for me."

You know, the discussion often comes to the issue of arrogance in doctors, wanting to control things. But in a real doctor-patient relationship, which is hard, as you say, patients want to know what their doctor thinks. One problem is there is little time for talk, just time to talk about a decision —

PROF. SCHNEIDER:  It always was.

DR. FOSTER:  It maybe always was.  Perhaps it is not as stark a new problem as we sometimes make it.  Well, you know, there's a difference between making an informed consent that's informed by the best science that you have and an informed consent that is given just because this is the way you feel.  I mean you've made that point.

I'm only arguing to say that I think most people really would like to have their physician giving an opinion about the best way to go when you have a serious illness.  A trivial illness, it doesn't make too much difference.  I think that they will oftentimes trust that, and I think that's what Franz Ingelfinger, that's why he wrote that article in defense of true physicians.  I know there are a lot of people who don't meet the standards of true physicians, but true physicians really do want to try to do what's best for their patients under the circumstances, whether to withhold treatment or to give it maximally.

PROF. SCHNEIDER:  Well, this is my opportunity to say that, of course, I agree with the heart of what you're saying, but that it's also true that bad things happen when you trust physicians, that they make decisions for other people sometimes rather rapidly and unthinkingly, and lots of people don't have physicians they trust, and never did.  It's not just managed care here; these are problems that go back decades and decades.

And I don't want to be understood to be depreciating any of the harms that are done when you set up a world in which there are not ways of stopping people from ending treatment on children where it shouldn't be ended.

But I also want to say the world has changed a lot.  It used to be that people wrote articles in medical journals talking about how they starved to death defective children in respectable hospitals.  Because social attitudes have changed so very dramatically about that, that is something which is now unthinkable or at least will produce very great anger and very considerable responses.

The problem, of course, is that we can't know all of the bad things that we object to confidently enough to be able to write these strong rules in advance.  That is what I'm having difficulty with.

DR. FOSTER:  Well, just to cite yourself in response, you point out that, whether it's the Supreme Court or anything else, there are possibilities of bad decisions that are made, not for bad reasons, but because the evidence is not there.

I mean we treated with estrogens for a long time because we think that this is good, and now we can't take estrogens because we're going to get cancer.

I always teach the residents, when the evidence changes, we change.  But given the evidence, the best that we have, I mean we're going to make mistakes because sometimes we don't know what the genetic background is and sometimes we're just careless, and sometimes we're just not meeting our responsibilities.  But there's never going to be a case, as your own argument was, from the courts where bad decisions are not going to — that's an irrelevant question to me.

The question to me is, do you get better decisions if you listen to the doctor as opposed to listening to the family under those circumstances?  Have you studied that?

I mean, the errors that doctors make are both sad and in some cases indefensible, but that's the question that I want to know.  If you take a large population in studying this — maybe there is such a study; I don't know.  You may know of such a study since you know almost all of this stuff.

But what I would really like to know is, would you get a better case from having consultation with the doctors and in general following the physicians' recommendation for care here or to simply say that the physician will give you — there are four ways you might treat prostate cancer; which do you want?  You know, you use those sorts of explanations, and they are likely to quickly say, well, if I can get by without surgery, I'm going to stick rods or pellets in my prostate, and so forth.

That's the question.  Is there a study that would give you some hint as to which, by any objective standards, you would get some idea about which was the best way to go?

PROF. SCHNEIDER:  It's the "any objective standard" phrase that's the problem, that has precluded any such study, because if you knew what those were, then we wouldn't have to be having these discussions.

CHAIRMAN KASS:  Paul McHugh, take the last question.

DR. McHUGH:  I have just a brief question and point because I found your paper so wonderfully enriching and very supportive of my prejudices.


PROF. SCHNEIDER:  I can't think of a better endorsement.


DR. McHUGH:  I've been fighting living wills since I first heard the term.

But there is an issue, and I want to come back to what Professor Wilson was talking about because both of you are my admired empiricists.  I believe that the assisted suicides in Oregon are usually killing patients of mine; that is, they're killing psychiatric patients, with other kinds of conditions, of course, but who have conditions that I usually treat.

Now that's an empirical question, and I would like to know the answer to it and I would like to have it proven or disproven.  But the people in Oregon who said that they set up this as an experiment now say we can't look at those records because of the privacy rules and the privacy kinds of things.

What are you lawyers going to do in relationship to this matter?  Because it's clearly an issue of conflicting goods here, but, ultimately, lives are at stake and the character of doctoring is also at stake.

PROF. SCHNEIDER:  Well, first of all, lawyers do what their clients tell them to do.  Second, I think that the Oregon experiment suggests one of the benefits of (a) the process I've been describing and (b) of our federal system.

Justice Brandeis famously talked about the states as laboratories of democracy, and this is exactly the kind of thing that he had in mind.

But you're quite right that this extremely valuable and possibly extraordinarily illuminating experiment that might answer the kinds of questions that we were discussing will be useless if you can't get the data.

DR. McHUGH:  It's a hell of a laboratory where they won't let you look at the data.

PROF. SCHNEIDER:  Then it's not an experiment.

DR. McHUGH:  No, that's right.

CHAIRMAN KASS:  Thank you very much.

PROF. SCHNEIDER:  Thank you.

CHAIRMAN KASS:  Thanks to both of you for really a wonderful morning.


We've run over a bit.  We were supposed to reconvene at 2:00.  Does anybody know convenient places where people could grab lunch?  There aren't any in this building.

PROF. MEILAENDER:  There's a Burger King not far away.

CHAIRMAN KASS:  We'll meet again at two o'clock.

(Whereupon, the foregoing matter went off the record for lunch at 12:36 p.m. and went back on the record at 2:05 p.m.)


CHAIRMAN KASS:  Can we get started? 

Okay.  This session, the last of our three sessions on issues connected with the aging society, is on the subject of aging and caregiving.  And the question is the question we started to discuss this morning as to whether there are objective standards for decisionmaking in caring for patients with dementia.

You'll recall that this was the major subject of discussion prompted by Eric Cohen's paper at the June meeting, and Rebecca has gone home and prepared a short working paper that's in your book — issues — it was kind of a summary of the issues for us to consider as we move forward in this discussion.

Let's assume for the sake of this discussion that we are beyond advanced directives, that we are beyond substituted judgment, and that we are talking about a situation where surrogate caregivers, whether court-appointed or in the better cases family members, and let's make the best case working in close consultation with physicians and nurses and all relevant parties.

Let's assume that we have arranged a procedure to optimize the consideration of the best interests of the patient.  Let's make that the starting assumption, that we've got the best procedure in place.

The question then is:  how do we want to think about the substantive issues of the judgment themselves, and, in particular, an issue that we raised last time — to what extent, and under what circumstances, should diminished capacity itself be part of the things that weigh into the process of making decisions? 

Should one simply content oneself with the fact that surrogate caregivers assumingly — assuming that they are the right ones and that we have the right settings, should have discretion to judge what is in the best interests here and now for those who are incapacitated? 

Or is it necessary to think in the abstract — and we heard Carl Schneider's answer to this question this morning — does it make any sense, not so much as a matter of law but simply thinking through the ethics of this, to try to think through in advance whether there are boundaries or standards to limit this discretion of the surrogate decisionmakers and caregivers that would protect the vulnerable against overtreatment, undertreatment, and active killing?

Should the people be free to decide whatever it is that they wish, or should there be any kind of boundaries or outlying guidance for those decisions?  Quite apart from the question of whether it makes sense a priori to do this, and I trust that the remarks this morning will meet some reaction from people who have further thoughts along that line.

If you assume that it might make sense to try to do so, one should recognize in advance the danger of trying to set forth such objective considerations, what degree of dementia might be grounds for treating a person differently than someone not similarly incapacitated. 

And one knows that at that moment one is introducing into ordinary discourse and with the blessings of practice, and perhaps even law, certain quality of life considerations that — just to repeat things that we talked about last time, that begin to suggest that some lives are not worth living or not worth sustaining.

On the other hand, as Rebecca suggests, not to do so explicitly, to pretend that we are simply having a procedural solution, is to ignore the fact that, in fact, such substantive choices are being made, and precisely with those kinds of values in mind — admittedly decentralized, admittedly people working it out on their own, and there is no opportunity to try to set certain kinds of limits where discretionary practice might, in fact, violate them.

So I think that's the first sort of dilemma that we face, and I think this Council ought to face the fact that at least one possibility looking forward is that if we do not think this thing through and work out some practice — some standards of practice, whether worked out in the common law manner or by some other means, we might very well find ourselves under circumstances with this increasingly aged and increasingly demented population that the absence of the willingness to grapple with this question through a decade of infirmity will lead to a great deal of increased pressure for assisted suicide, and these quick solutions for failure, actually, to grapple with the delicate decisions that people are making.

Second point by way of introduction, the last time we sort of tried to take this up in the light of the big questions, in terms of the categories of moral decisionmaking, but let me suggest that to see if we can put those intuitions to the test, to try this time not to sort of stay at the high level of abstraction and talk about whether dementia should count or not, but to take up the three sort of short cases that Rebecca has really in the — in the last paragraph — is it the last or the second-last paragraph of her paper on page — the bottom of page 8 and the beginning of page 9, and try to proceed somewhat casuistically through these different cases to see whether people's intuitions are such that, assuming that we had to take these things up cases by case, whether there are the beginning stirrings of what people might want to say by way of standards.

That I think might be an easier way to proceed, so let me read the paragraph aloud and put it on the record.  "An analysis similar to the one used in the discussion about the circumcision case could support classifying certain dementia treatment decisions as outside the limits of acceptable family choice.  One example would be family refusal of oral antibiotics for a patient with mild dementia who retains the ability to enjoy numerous activities and relationships.

"A much closer case is family refusal of major surgery or chemotherapy for a patient with moderate dementia.  In this situation, the patient may be unable to understand or remember the reasons for the restrictions and physical discomfort the interventions would impose.  Some people would see this treatment question as one that the family should be free to resolve; others would disagree, arguing that non-treatment would be too detrimental to the patient.

"A third case is family refusal of tube feeding for 'barely conscious' advanced dementia patients.  Although this option may not be covered by a narrow concept of the patient's best interests, it is often defended as a reasonable choice in light of the questionable benefit that tube feeding confers on such patients."

And Rebecca, in a way, invites us to try out some kind of robust, objective approach to treatment decisions, suggests that developing such an approach requires really public and professional debate over cases like this.  And we could multiply them.  I mean, in fact, one of the troubling things about trying to develop any kind of standards is the number of cases are really quite infinite, and the facts will govern.

But, nevertheless, since this is — this is where the last discussion and this paper have led the conversation, let's try it out and let's — if you're willing to simply follow an agenda where we take one case at a time, let's start with the middle case, and then work to the — either side.

We have a case of a patient — again, these are generalizations and we — probably each of us are filling in the details with mental images in different ways.  We have a case of a patient with moderate dementia unable to understand or remember why it is that what happens as a result of this intervention is happening to them.  And the question is:  might the family, under those circumstances, refuse major surgery or chemotherapy for such a patient?  And, if so, how would you justify it, or why or why not?

Jim, on the merits, or do you want to change the procedure?

PROF. WILSON:  I don't want to change the procedure.  I just want a brief introduction from one of our physicians here.  Would somebody try to explain to me briefly the differences between mild, moderate, and advanced dementia?

DR. FOSTER:  I think that's largely subjective.  I don't — I don't think that there are any defined, you know, rules like a DSM, you know, that you detest so much over there, Paul.  I don't —

DR. McHUGH:  I think there are real differences.

DR. FOSTER:  Well, yes, I think there are real differences.  I mean, they are trying to describe this subjectively.  The first case can enjoy things, and the other one can't remember anything, and the other is very — I mean, so they're just — it's just broad sweeps I think.  I don't know.  Paul may want to comment on —

CHAIRMAN KASS:  We had criteria — remember, was it Geri Hall who was here?  Her presentation?  David Shenke in his book goes through this with — in a kind of narrative and descriptive way.  But there were a list of criteria at least that the profession uses to more or less categorize people knowing that the boundaries are entirely gray.  Is that —

DR. McHUGH:  Well, it's a graded phenomenon.  But if you took a disease like Alzheimer's Disease, there's no question it falls into three stages.  The first stage, in which fundamentally the major problem is simply memory impairment, an inability to form new memories even though old memories and old habits and style and those kinds of things are fully intact, and the person is quite able to enjoy things. 

The second phase that comes after about three, three and a half years into Alzheimer's Disease, is a phase that begins with a gradual loss of language capacities for some and apraxic problems; that is, the ability to kind of dress yourself and do those things, depending upon which hemisphere has the dominant affliction. 

And associated with that is an advancing aphasia, language problem, or an advancing inability to use your arms/hands appropriately, and sometimes with it hallucinatory and delusional experiences, which are very, very distressing for the patient.  But, again, they often can enjoy things and obviously can continue to recognize people.

And then, the third phase is a phase of progressive paralysis, a total absence of essentially capacities of understanding, the development of Kluver-Bucy Syndrome, where people are putting everything into their mouths and fundamentally are bedridden and twisted into a spastic paralysis state.

So, and those three big stages.  And the Mini Mental Status Examination, which we wrote and now is the standard for the following of the decline of cognitive powers, would split it up into having the total Mini Mental score — the perfect one is 30.  In sort of the first stage the patient runs somewhere around down to 20.  In the second stage, they run down to about 12.  In the third stage, they're 11 and below.

CHAIRMAN KASS:  Anything else before we tackle this?  Granted, it's hardly — I mean, it's a barebones case.

DR. GAZZANIGA:  It might be an interesting exercise to before —


DR. GAZZANIGA:  — before those of us who are charged with dealing with these patient situations, to have our two physicians say what, in their experience, is their practice given — to start off with, on each of these cases.  So if you want to take the second case first, and that was your patient, how would that play out at Southwestern?  How would that play out at Hopkins?  How would it play out with an internist?  How would it play out with a psychiatrist?  As a place to start.

CHAIRMAN KASS:  Excellent, if they're willing.  Paul, would you start?

DR. McHUGH:  Yes.  And that's a good — that's a good approach.  By the way, though, I have to have a preamble —

CHAIRMAN KASS:  Professors always do.

DR. McHUGH:  — before I —


CHAIRMAN KASS:  That's your privilege.

DR. McHUGH:  The major problem for most of us, and for most onlookers, is that you don't — that we don't offer to patients with dementia and with Alzheimer's Disease in particular optimum care.  Nursing homes are fundamentally psychiatric hospitals, it turns out, but you can't call them that because if you call them that then they don't get appropriate Medicare services. 

But they are psychiatric hospitals, and they should have all the kinds of things that go into a psychiatric hospital, not only full evaluations but occupational therapy, social work, family work, and the like, and ultimately the implementation of a — the least restrictive environment that a person can live in.

And when Alzheimer patients live in such environments, everybody comes to appreciate how much they are enjoying life, how much they get from life, and things of that sort.  So that even in the categories that I was laying out for you, much would depend upon whether this person was fundamentally being warehoused in some nursing home that just did think of themselves as a repository for the demented, or whether they were living in the appropriate kinds of Alzheimer services that lots of us are trying to build and demonstrate that they are not beyond the powers of a reasonably prosperous country.

So a lot of that will determine a little bit about the way you look at these things.  But, you know, each one of them is progressively more problematic, obviously. 

Now, for me, you know, I do everything, but with — with explanations and work and appreciation with the family.  Oral antibiotics for somebody with mild dementia — I give it all the time, and I explain to people that, of course, I'm going to give this, and I tell my patients who worry a little bit about what I'm going to do, I say, "Don't worry, I'm going to be there with you.  We're going to get you through these various things.  It's not as bad as you think," and all of that.

The second one in which you think that you have a person, say, in the second phase of Alzheimer's Disease where they are prone to delusions and hallucinations, and the like, the issue of, well, would you go in and — let's say, because he as well suffered from Hepatitis C, had developed a hepatoma with metastases, would you go in and take his liver out, give him a liver transplant, replace the invaded inferior vena cava, and the like?  Would you do that to him and expect him to really make it and get through and understand it?  You probably wouldn't.

If, on the other hand, the person had a leukemia or a blood dyscrasia for which a short period of chemotherapy would be successful and might, again, give him a few more years of the life that was — everyone agreed he was enjoying, well, then, you would do that.

When it comes down to the last one, where it says when and where you put a gastric tube in, then you begin to wonder how much you're making this person suffer from the tube and from the fluids that you're going to give them.  And I probably would say at that point I wouldn't do a gastrostomy or put a tube in, but I might try to work with intravenous, recognizing that we're close to surrendering here.

Ultimately, this all comes back to my discussions with — that you've heard me say before, and the like, that I think that when you take on a patient with Alzheimer's Disease or other forms of dementia, you are taking a contract with that patient to fight for him against this enemy, this disease.  You and the patient have decided, we're going to work against this.

And we know that this is ultimately going to be a victorious enemy, but we're going to fight as long as we can.  But we're also going to agree that there's a point where we're going to surrender.  And my concern is that we betray the patient rather than surrender too early.

So being with the patient, having them know who you are, having them work for the best kind of environments that they can get with, and eventually surrendering, is my practice in general, and in these specifics would inform the decisions that I was making.

What do you think?

DR. FOSTER:  Well, I don't think that we're too different from this.  I would use a generalization that — in the first two cases that we — where medical procedures are indicated, that we would carry out the medical procedures regardless of the status of the dementia, taking into consideration — for example, if we took your case of Hepatitis with a hepatocellular carcinoma, well, the survival rate of that is so low that you wouldn't do it. 

It would have to mean that the intervention had some reasonable effect on allowing the patient to continue the sort of life that the patient had.  So that we would not — we would not back off, or really would not honor a family's position, I mean, once they — they came into this.  I guess we have to have permission to operate, if we did it, or chemotherapy.  But, I mean, we would try to argue that.

The third case of feeding is much more optional.  If you are near the end stage there, then that's not really a medical procedure.  That's a nutritional procedure that you're — that one is talking about.  And there one would make a decision in several ways. 

For example, if the patient was not wasted — that is to say, that if the person had adipose tissue on, lots of stored fuel, I mean, and most people in the country these days have lots of stored fuel, they don't need any calories to be fed anything, so it's only a matter of maintaining fluid, which could be done by a tube or not.

Now, but that's not a medical — that's really not a medical problem.  We'd have to go — go back to the other issues along this.  I would say that the — that for people who want to die for — you know, who are of their right mind and they want to die because of terrible diseases, and so forth, that starvation is a very good way to go.

Our former — used to be the former head of the Pharmacology Department at Yale, and was our Graduate School Dean, had ALS.  And towards the end — I wasn't originally his — didn't take care of him, but I took care of him at home, and so forth, and I'll never forget that he — he was perfectly bright, and so forth. 

But I got home from church one Sunday, and his wife called me and he could just barely speak, that she could read his lips, and he said, "Tell Dan Foster I'm going to die," you know, and so he chose the way to die was not to eat, because if you don't eat any calories what happens is that you lose hunger.  I don't want to get too technical, but you get accumulating in the blood what we call ketone bodies, and ketone bodies stop the hunger drive that's present in the hypothalamus there, and so it's a very peaceful way to go.

If you don't give fluids, it's not going to last too long.  If it's just — if you're giving fluids, it's going to last longer, because you then have to use up all of the calories that you've got stored in fat, you know, so that's a long procedure to do that.

So I would think that I would not have concern if the — and my judgment concurred with the family's judgment that this was not a meaningful life, that this would be a peaceful way to go, in contrast to, you know, shooting somebody with, you know, potassium or something like that that we're talking about.

So I think we'd be in agreement.  I would — we would treat both things, and it becomes even stronger if the mental retardation is at a young age, you know, where you don't — let's say you've got a Down's Syndrome that you have — have this.  Well, you know, that would just be unthinkable to not give therapy there; it's different.

So I don't know whether that's clear, what I'm saying.  I think it —

DR. McHUGH:  But I —

DR. FOSTER:  I think Paul and I are pretty much agreeable to most of these —

DR. McHUGH:  But I think what you've seen in action here is a kind of conversation that would take place between a good internist and perhaps a good neuropsychiatrist caring for the people.  We would talk back and forth exactly in this way, understanding what we're trying to do, weighing — because we would be on the patient's side and thinking in terms of what we were doing for him or her in this process.

And these ideas that Dan has brought out, and showing you what he appreciates and knows about these matters, would obviously enrich any actions that were being planned by the neuropsychiatrist.

CHAIRMAN KASS:  Does someone want to join either of these two beginnings?  Well, then, let me do it.  I'm sorry.  Peter?  Peter, would you turn on the —

DR. LAWLER:  It seems to me in the first case that it should simply be illegal to refuse the antibiotics.  There should be, and I'm sure there is, legal protection.  In the second and third cases, they regard prudential judgments, which I think are beyond the law, because chemotherapy, well, kind of depends. 

If it's a relatively light dose, but if it's a most — I've seen people with the most horrible kinds of chemotherapy, where I think you might withhold that for the reason that if you yourself, as a competent human being who didn't have all that long to live, were offered the possibility of chemotherapy, that would be a judgment you would make.  You might turn it down, or you might have it.

So someone who is — can't think for him or herself, someone has to make this judgment for them, and certainly you two seem very reasonable.  The presumption would be in favor of the treatment, I agree completely.  But I don't think it should be necessarily something — a legal matter necessarily, because of the great amount of prudence there, although I would be very much in favor of the presumption of treatment.

But, number one, I think it's a matter of the rights of the human being.  Number two, not so much.  Number three, again, it's a prudential judgment right.  They require many factors to be considered, if someone is going to die soon, who is severely demented and is going to die soon anyway.

So in the discussion this morning I was a little bit taken aback because the word "rights" is — in this best interest thing, I think there's a danger that the word "rights" never come into play at all. 

For example, someone who is the example Gil gave us, a baby who is retarded, I think it's a matter of rights that if there is a relatively routine operation that would allow that baby to live, the baby has the operation.  It's not a matter of anyone's prudence.  It's a matter of legal right.

So one thing we have to talk about is people, babies, people who are demented, and so forth, is this best interest thing I generally agree with, but there are limits to it, and the limits are the rights of the being involved.  I think we can get so caught up in prudence our rights disappears on us altogether.

I'm all for jettisoning autonomy as fundamentally an evil, unempirical word.  But I'm not so — I think maybe the danger of best interest talk is we jettison rights altogether, because I think in the first case here it would be — it should be simply illegal to withhold treatment.  Like for the baby who is retarded, it should be simply illegal to withhold routine treatment that would allow that baby to live.

DR. FOSTER:  Let me just respond.  You know, there actually are not legal rules about — of using antibiotics or not using.  That's left to the discretion of the physician.  And also, the use of a drug and something is not approved by FDA is at the discretion.  The remedy for that, if a person does not follow high quality, is actually vested in the courts from malpractice, and so forth. 

But there are no — there are not — you know, I mean, there are certain things you can't give narcotics, you know, without — and so forth.  But by and large, it's left to that, and sometimes because we overuse so many antibiotics, and so forth, if it was just a mild, you know, illness we just might, as a matter of practice, say, you know, they've got a cold and we're not going to give them anything. 

So I just wanted to say I don't — you know, it's not — I agree in principle with everything that you've said here, but there's not a — you know, it's not a governmental list of things that you can't —

DR. LAWLER:  Right.  But malpractice is a law, though, right?  You should be up on charges if you let that go.  And if anyone notices this, the person should try to bring you up on charges.  Not that you would ever do anything of this nature.

So, number one, it would be withholding of the antibiotics, or whatever, with the intention that the patient die as a result, not as a prudential medical judgment.

CHAIRMAN KASS:  Well, I mean, now there are several people to bother, starting with Peter.  I mean, you'll recall that in Eric's paper — and it consumed a lot of our discussion last time — was precisely such a case where you didn't have the surrogate decisionmaker, but the question was thinking it through for a person competent to refuse. 

And there was some discussion as to whether one was going to describe such refusal as opting to live a certain way while dying.  And a position I took, and was challenged by Charles amongst others, say, "That's just subterfuge.  This really is a choice to elect death by this means now rather than linger on with the other."  And there is a tacit sort of quality of life consideration that's there.

Even Dan, in his last remark — and by the way, I liked the comments, and I would happily place myself or anybody I loved in the care of both of these gentlemen — so I didn't dissent from things that were said.  But even in the very last comment that Dan made, talked about that there's not much meaningful life here, and when — the question was, whether there are these objective standards or values came up this morning, and Carl Schneider said, "Well, it all depends upon what they are."

Once you introduce the notion of the meaningfulness of life, then it's not clear to me that the judgment of that is the physician who is committed to making war on Alzheimer's Disease has the best perspective on what it means to live with that disease. 

So I'm going to use that as a transition to go back to — to Paul.  You are committed because you have a certain view of the worth of every human life, no matter how reduced.  You have a view of what your obligations as a physician are.  But I'm the spouse of this woman who has this terrible disease now, and let's put her in this immediate middle sort of condition, and you and I both know what's coming.

Do you want me to stop?

DR. GAZZANIGA:  No.  I'm going to answer your question.

CHAIRMAN KASS:  Oh, okay.  Good.


And I say, "Look, we've talked about this for a long time.  I know what she values about life.  I know what she thinks about her relation to her children.  I know what kind of memory she would like them to be left with." 

And I'm going to take a slight variation here on the case that Rebecca has given us, because chemotherapy — Rebecca has made it somewhat easy by saying the patient can't understand the restrictions or the physical discomfort that you're going to — we are going to subject her to by virtue of being — acting in her best interest.

But let's say she has a Stokes-Adams episode or something like that, and it's up to you and me to decide whether to put a pacemaker in.  And then I say to myself, you know what, if she didn't have the misfortune to be in our clutches, medically speaking, this might be a good way out.  I'm not wishing it.  I'm not trying to arrange for it.  It happened.

But we've now got a kind of new situation, which I want to say to you, you know what you're doing, Paul?  You're a good man, you're a good doctor, I like your values, you're going to make sure that people are not taken advantage of.  But in these circumstances, with this patient, you are, in a way, choosing not only to fight the disease but to make sure that the patient lives to suffer every last vestige of degradation that this disease is going to prove.  And I know my spouse, and she would hate me for acquiescing in that.

PROF. GLENDON:  What's Stokes-Adams?

CHAIRMAN KASS:  Just a heart block —

DR. FOSTER:  It's a loss of consciousness secondary to obstruction to the aorta.

CHAIRMAN KASS:  It's a brief arrhythmia of the heart which relieves itself, and for which the treatment is a relatively easy procedure.  You put a pacemaker in and a battery, and you can prevent it by and large from happening, unless — I'm all right so far, Dan, on — I'm okay?

Now, maybe Mike wants to solve this.

DR. GAZZANIGA:  Well, this gives you time to think, Paul, so I'll take a shot at it.  No, it's the exact middle ground question that is the harder one.  And so let me propose that what's emerging out of modern neuroscience, modern human neuroscience, are some remarkable findings that basically allow us to capture, using neuroimaging, whether someone in fact has a sense of self.

And so just to make it concrete, there are little tests that one can develop where you can see whether — I mean, it's a fact that if I give you things to remember that have self-reference to you versus reference to others, the ones that have self-reference to you are remembered better by you.

And these tests — and there are many, many of them like that — light up specific networks in the brain.  So one could imagine that you could take this profile, this new profile — before you're going to make this decision, your spouse has been worked up on these tests, which are going to show whether, in fact, any of the self-referential aspects of life are active, are working.  I mean, it's just going through.  There's no spark, there's no individual recognition, there's no evidence — and behaviorally, of course, that is apparent. 

But if that sort of biomedical aspect was brought to the table in this decision, would it not — and I don't know the answer to this.  I don't know what my position on it is.  But would it not add to the information people would want in trying to make this decision that this person simply no longer has active the neural networks that we know are crucial for recognizing new information related to the self versus others?  They're not there.  They're not working.

CHAIRMAN KASS:  You want that to count more than whether she smiles at me when I'm in the room?

DR. GAZZANIGA:  Those, as we all know, are tremendous — can be tremendous automatisms — automatic behaviors that are greatly fulfilling to you but have absolutely no meaning to the patient.  That's all we —

CHAIRMAN KASS:  But that's why — that's the point of introducing this.

DR. GAZZANIGA:  Yes, that's the heartache of the whole process.

DR. FOSTER:  I have a quick question.  In practice, I mean, to do that sort of imaging on everybody who is in this condition is going to bankrupt the country, right?  I mean, is what you would learn from that worth what the cost would be from, let's say, functional MRI or whatever you're talking about?

DR. GAZZANIGA:  Well, it just changes the flow of money.


It's the same dollar.  It's just, you know, where it floats through.

I mean, the fact of the matter is we're an affluent country.  There are people who would get the service, people who wouldn't.  So that — that point aside, I know that's a very complex issue.  But I'm just trying to think ahead to — I'm seeing what's in the tube here in terms of the neural networks that are going to be worked out. 

And someone is obviously going to say, well, should we apply these questions to the demented population to see if we should withhold medical care?  I mean, that's the only reason.  I mean, that's the only objective here.  But I don't know.  I don't know if it's a good idea or a bad idea at this point.

CHAIRMAN KASS:  You've had time to think.

DR. McHUGH:  Well, no.  I want — again, the real problem with these hypothetical questions is you can build a pig with wings, you know, and does it fly, or doesn't it fly, and how would you work with it?  And, you know, then I come back with other kinds of aspects of the hypothetical, well, you know, how has this person been doing?  How has she or he been enjoying the life that he's had so far up 'til now?  What was the original deal that we had together when we decided to engage in this battle?  And the like.

And most of the time I think that in these things the family turns out to, once again, follow the judgment of the doctor.  You said that, "I wanted to fight to the — into the third phase of Alzheimer's Disease," or something of that sort.  That's not necessarily true.  I might be prepared to surrender at an earlier time if things turned up.

But then you have to then — because you make this so personal, it becomes personal with me.  And, you know, I've watched the lights go out a lot, and let me just tell you it's — Dan will corroborate — it's not happy when the lights go out, and you don't like it, and nobody likes it.

And sometimes in certain situations, even though you have agreed that you're going to do one thing, at the moment you don't do one thing.  And I — I've gone over these stories before with this Council, so I won't bring my war stories back to you.

But for the most part, it seems to me in the situation that you put forward that if the doctor to whom you had entrusted this battle with, and whom had not only a relationship with you but a relationship with the patient after all because he has seen him or her since the beginning of this, that you and he — you might defer to his judgment, particularly if you came to agree that there were things that ultimately other than simply turning into a pretzel would — would get you — get the surrender to occur.

Now, but if you push your argument all the way to me and say, "Look, Paul, I want this done this way, and you want this done that way," given the social situation that we have, you dismiss me and take your patient home, and take care of her and you become the person.  And no longer am I — no longer am I the doctor/clinician in this situation.

I am not a waiter.  I don't bring you a menu.  I don't — I bring you a prescription.  I explain — I know I'm going on too long.  But this is what I do.  I bring a prescription that's based on my knowledge of you, the situation, the condition that we're in front of.  I want us to agree that this is going to be a 24/7 concern, I'm going to be thinking about, as you're going to be thinking about it — all the way.  We're going to take these judgments into account, but I'm going to do the prescribing. 

CHAIRMAN KASS:  With the Council's permission, may I go one more — one more round briefly to see if we can — this is not a question of who has ultimate authority.  It was really a question to your own thinking and how — it was, in a way, to wonder to what extent — and you partly gave — gave satisfaction in the course of that discussion where you say — when you say to the patient at the beginning, and it sounds like the tacit contract, "I'm with you through this disease thick and thin.  We're going to fight it together." 

That might be a very short conversation, or it might be a very long conversation in which the details of when we move from battle to surrender.  And it might be different in different patients.  I mean, you've indicated that in this reaction.

But it — I wonder whether it ever occurs to you as the physician in charge that you are, whether you know it or not, selecting this kind of death rather than that kind of a death for a patient, and whether that — whether these kinds of situations that Rebecca has elaborated for us don't somehow force that question in a way that it doesn't usually occur where you've got a sick person who comes for relief, you know they want to get well, you know they're going to be restored to their life, and the question is:  what's the most effective means to it?

We want to say — I think the group — so far no one in here has argued, so far, that we really want to say that the line between maybe allowing to die and deliberating killing should be fudged.  I think no one has dissented from the principle Eric laid down last time that there should not be an action which deliberately intends the death, elaborated by Robby and others.

But the questions about withholding for various kinds of reasons, without death being the simple choice, is a much more common decision than the circumstances that invite thoughts about assisted suicide and euthanasia.  And it seems to me that these kinds of cases in the middle are such, and we're trying to tease out the question of:  where one is in the presence of the kind of incompetence that, let's say, Alzheimer's, produces, especially in the advanced stages, to what extent that very condition and the life that the patient has is part of your consideration about intervening.

So far you and Dan have said, for the most part, not.  Dan said it quite explicitly.  The mental defect is no part of the consideration.  If it's medically indicated, it's medically indicated.  The last thing becomes optional, because it's not medical but nutritional.  And that, in fact, not doing so doesn't produce a painful death anyhow.

But I'm wondering whether it's too narrow to take a merely medical view of the kind of life that you are helping to sustain when you've got people who, if you act the way you normally act, you are, in effect, consigning them predictably to a kind of increased miserable conclusion.

I'm not arguing the opposite position, but I'd like to hear how you — how you would deal with a patient who has thought about this a lot, and who says, "Look, there is more here than just the body.  There is the life that this person had led and the relation to the children and the grandchildren, and I know what this person would like.  I know that the point of surrender for her would be a lot earlier than it would be for you or even for me."

And the best interests of this patient — of this patient might, in fact, permit one to forego treatment that the presumption, generally speaking, would be in favor of making.  And I think I spit that out tolerably well.

DR. FOSTER:  Let me try to answer this.  I mean, you know, all moral or ethical questions that are serious are gray.  Okay?  They're not black and white.  And most of the time the issues are not that complicated, and a prudential answer in the Aristotelian sense is just a common sense answer almost everybody will agree on.

So I'm not — if I'm taking care of you or Amy or something like that, and it looks like, you know, the Leon Kass that I used to know is — is not the same person, and that I know you don't want to be, you know, you're not going to find me fighting or Paul fighting to do that. 

If it's — I mean, it's pretty — it's not real hard, unless you have some mystical view that — that even though death is very near, that that — that every speck of sustained life has to be sustained to the last point, that's what you're arguing about.  Nobody wants to do that at all.  All we're trying to say — he uses the term "surrender."

You know, I mean, I — oftentimes, you know, we say, well, we're not going to do this.  It's not — in the first place, it's not medically indicated, and so forth.  So most of the time you don't — in big-city hospitals, which is where I work, I mean, we don't usually need ethics committees, and so forth.  I mean, these are — and they're not paralyzing things. 

I mean, occasionally they're paralyzing, but most of the time they're common sense that any — you know, you take 100 laypersons and show them — the person there, to look at them, and give them the facts, and they would almost always opt along the same line that the family or the physician want to do.

So I don't want to build this up as though this is some sort of a huge emotional problem.  Most of the time it isn't.  It will be if somebody feels radically that you have to sustain life to the very — you know, to the very end.  But day to day you don't see that, and most of the time it comes when there's a conflict within the family, where — you know, where a brother wants to do one thing and a sister wants to do the other.  We can't kill mom, you know.  Well, we're not killing; we're just not going to give her the chemotherapy, whatever.

I hope that's clear, what I'm trying to see here.

DR. McHUGH:  Well, and I want to kind of back that up, too, because that's exactly what usually happens.  It's a gradual process of understanding where we are, and we want the family, like Jim said he and his sister were, coming together about what these implications are and things move fairly smoothly.

The reason that I awoke to this idea of the Stokes-Adams, a sudden event, is that I've been in those situations when the promises that I had made, even I had made, I didn't carry out at that moment.  I might have mentioned this case before, but this was a case of a patient that I was taking care of who had advanced COPD; that is, difficulty in respiratory things.  And she as well had, as often is the case, serious psychological problems with it.

Now, I liked her very much, and I admired her husband and her family.  I knew them.  I thought the world of them.   And the one thing they had said is, and she had said to me is, "Don't put me on a respirator."  I said, "Don't worry.  That will be fine."

Well, this day she was with me on the psychiatric floor, and we were working on her emotional anxiety reactions.  And she just started to go right then, completely unexpected, her husband wasn't in town, nobody was there — just me, the resident, and her.  And it was like watching somebody carried out in the undertow, and I reached out, I got the code people, and I put the respirator on her.

That evening I went out thinking, holy cow, what have I done?  I've done all the things that are against what I wanted to do.  I had dinner with the Humanities Group at Hopkins, who I agonized — agonizingly told this little story to.  And I was savagely abused as a dirty rat, and I should have let her die.  Thanks a lot, fellows.

And then, the next day I came back, she was in the care unit and things.  Her husband said — I said, "Gee, I'm so" — he said, "I think you did the right thing."  I said I — and I went, "The respirator, I think we can get her off.  I think we can get her off.  It's going to take about three days to a week.  We can get her off."  And each day I would go and hold her hand, rub her shoulder, you know, "It's going to be okay."  And we got her off.

And when we got her off, it was clear now that everybody had now come to town, the children and everything.  She was very precarious, and we all agreed now that was it.  We had done it, but we weren't going to do it.  And in the next two weeks she slipped away, and everybody, including me, was pleased that I had reached for her at that moment.

Now, to come to your case, is the Stokes-Adams thing a sudden — well, I think if that happened right then, I was watching, I know I — I know what I'd do.  You just see them going, and you can't stop.  Then, after that, we could talk and all of us would be saying, "Okay.  This is not just a one-time event.  This is going to happen and maybe — let's decide whether we are going to put a pacemaker in, or maybe we won't."  And then, we would work it that way.  Okay?

PROF. WILSON:  Could I — what do you think of your colleagues in the Humanities Department who would attack you for having done this?

DR. McHUGH:  I just felt that — Jim, I just felt that they were part of the contemporary theory that, you know, autonomy is everything, the no sense of the community of which a doctor is a part, the relationship you have to somebody.  I just — well, I was zipped, of course, with them at the end, and I told my wife, "We're not going to have dinner with those people ever again."


PROF. WILSON:  Come over and have dinner with me.  I won't treat you that way.


DR. FOSTER:  A difference — the reason that you did I think absolutely the right thing is that she was not at the edge of life from her chronic obstructive lung disease.  And, therefore, this was a new thing, and she might have had six months or a year of good — relatively good quality of life.  So it was — your physician's instinct was absolutely correct here.

That might have been absolutely incorrect if this was case three who was lying there, you know, with nothing at all for you to intervene when, you know, your — so it's a different —

DR. McHUGH:  I just wanted to answer Leon's question in the experience.

DR. FOSTER:  It didn't negate your — what you had committed to do or anything else, because there was a new element that had entered into it, where you had to respond knowing that she might have — now she only lived two weeks afterwards, so it was close.  But a lot of times they're going to live for — so I'm saying, with Jim, that you got attacked in the wrong way for this one.  Okay.

CHAIRMAN KASS:  I have Gil, and then Peter, then Charles, in that order.

PROF. MEILAENDER:  I think this is becoming altogether too harmonious.


And I'd like to change that.  First — I have several different comments.  First, a comment on cases two and three as Rebecca has them here, not your reformulated one, which I'll come to.

I myself am inclined to think it easier to acquiesce in a family refusal in case two than case three.  In case two, at least in many circumstances, there might be some reason to believe that the patient found the treatment burdensome and was bothered by it in various ways, and it could not be explained to that person. 

And I would be inclined to take those sorts of reasons seriously.  I mean, I don't know if they're definitive in every case, but they'd certainly be powerful, and I wouldn't necessarily argue against them.

Case three, I think there was a kind of assumption in our discussion of it that this person was about to die, but I take it a person can be in an advanced state of dementia and live for — for some time.  And if that's the case, it's not clear to me that there is some reason in the best interest of this patient not to feed them.

You'll notice that it's also not clear to Rebecca, who says, "Although this option may not be covered by a narrow concept of the patient's best interest, it's often defended," etcetera, so that it's — I think in some respects it's harder to make a general case for refusing in the third instance than in the second that she cites.  So that's one comment I'd make.

A second one — Leon, you said that no one here had fudged the distinction between allowing to die and deliberately killing.  I don't think that's quite true.  I think you have fudged it.  in your discussion of — your reformulated case two, which I grant you is a different sort of case, but you'll recall that your — what you were going to say to, Paul, your doctor there, was that we know what's coming.  That is to say, what's coming is a period of time, a period of life, that we don't find very desirable, and would prefer not to — not to go through.

CHAIRMAN KASS:  That's an understatement.

PROF. MEILAENDER:  Yes, I understand that.  Which is to say, what you're saying is, so we will seize the occasion presented us here to — to decline to treat, so that she'll die now rather than at some other point.  That is to say, we'll seize the occasion to get this death right now.

Now, I want to notice that one could say exactly the same thing in case one with respect to the antibiotic.  There, too, we know what's coming, even though the person is in a mildly demented state.  And we don't find what's coming desirable, so we might well seize the occasion there also to — to see to it that that didn't happen.

So although I understand the — at least I hope I understand the difficulties of the kind of case you're talking about, I think that it's, at least in morality, much trickier in law I would certainly grant, but at least in morality there are certainly instances in which one can aim at someone's death by not doing something, or by withdrawing a treatment.

CHAIRMAN KASS:  Gil?  Just a tiny point, just a very tiny point.

PROF. MEILAENDER:  I've waited patiently.


PROF. MEILAENDER:  And my third point would be, if we're talking about boundaries, it seems to me that the furthest boundaries that we ought to set is to say that we ought never aim at someone's death.  We ought never deliberately aim at it, and we ought never make judgments about the comparative worth of other people's lives.

Now, it will be hard to know how to apply those boundaries in various cases.  They will leave room for all sorts of latitude in a lot of circumstances.  But that, it seems to me, is where we ought to start. 

So now you can make your corrections, Leon.

CHAIRMAN KASS:  Just a point of information, and then I — I really don't want to argue it.  I agreed — the case of the immediate fainting episode is very much like the patient — Paul's patient who turns — who stops breathing.  My question was:  do you then put the pacemaker in?  That's not somehow choosing death right now.  That's choosing to roll the dice on a cardiac death rather than a long, lingering death from Alzheimer's. 

And that, it seems to me, is not choosing death for the patient, but recognizing that I'm — by putting in a pacemaker, I'm in a way complicit in the very likely prognosis here.  And we don't know whether there's going to be another episode, whether it's going to be lethal.

The immediate episode, someone drops — stops breathing in front of me, I resuscitate them until I know otherwise.  So that was — it was just a factual difference, and, therefore, I don't think it's a case of electing death.

PROF. MEILAENDER:  I'd feel more comfortable about that answer if it were not for your formulation about we know what's coming.  It seems to me that that does imply certain kinds of judgments at work.

CHAIRMAN KASS:  Thanks for your indulgence, Peter.

DR. LAWLER:  All right.  I first want to say, case three, read the way Gil read it, he's right.  Case three is not really fleshed out enough to be read at all, I guess.  It's really information-short.

But I think I agree with Gil on — on Leon, too, being a little bit overwrought or Nietzschean about all of this or something.  For example, if you yourself have some horrible disease that has just started up, and you know what's coming, but meanwhile you need a pacemaker to get through the day, you can turn down the pacemaker, if you want, as a competent human being.  And we can divide up into small groups and argue whether you're courageous or wimpish about that.

But when you're deciding for someone who is moderately demented, it's quite different.  I think you would have to go with a pacemaker; it's a simple procedure.  And all your talk about "given the life this person led" — . , this person, as Rebecca points out so eloquently in her second article, this person is not living that life right now.

She points out people with Alzheimer's are a lot happier than they ought to be, given what's coming and everything.  So you're kind of imposing that person's, you know, kind of autonomous framework or something on the person's present being, which is really quite different and not nearly so anguished as your view of that person's present being.

So from my point of view, putting the pacemaker in, which I guess does not hurt very much and is relatively routine, would not be — especially in light of what's coming, would not be a close call at all, and shouldn't be regarded as a close call.


DR. KRAUTHAMMER:  First, to answer Jim Wilson's question about how Paul felt at the Humanities dinner, I think the appropriate answer would have been to go to Medical Records, pull the chart of every member of that group, and write in "DNR."


Poetic justice for them.

CHAIRMAN KASS:  Do you want this on the record, Charles?

DR. KRAUTHAMMER:  Absolutely, yes.


I've written a lot worse.


In answer to Gil's point, I think your trouble was with Leon saying, "We know what's coming."  What if he had said, "We know where you are"?  In other words, what if the criterion for the heroic intervention, or semi-heroic, or intervening at a point where it looked as if nature was going to act as the undertow, to quote Paul?

What if the criterion were not what's coming but the state that you're in?  And what if I were to propose that the decision you'd make is whether the person, in their present condition, were relatively happy or comfortable if unpleasant — in an unpleasant situation versus whether the person was either suffering or degraded?

That's not a projection of what's happening in the future.  It would be an assessment of where they are now.  And I think you could make a reasonable argument for making a decision about intervention of the kind Leon was discussing on the grounds of suffering and degradation — again, assuming that you're not — you're acting in what you perceive as the best interest of the person rather than a subjective projection of what that person would want, assuming we'd really have no idea what that person would want.

I think we can promulgate reasonable rules.  What I would like to suggest is that we ought to promulgate the rules with the understanding that there will be very little sanction for those who transgress.  For example, the bright line rule that Leon had suggested earlier, you don't kill, but under certain circumstances you withdraw treatment, which is exactly how we conduct medicine in the real world all the time.

I think there's a very bright line, and yet we know that we have a rule of secondary effect in which you'll give an overdose or a high dose of morphine to treat pain, knowing that it may have an effect, or it will likely have an effect of killing a patient.  I'm not sure any of us — at least in law as I understand it, it's permitted.  I'm not sure that ethicly it ought to be not permitted.

In other words, even the bright lines that most of us accept I think we also accept with the understanding that given the individuality of every case that it is impossible to make rules that are universal, and that we ought to have a high tolerance of those who will transgress them in particular circumstances.

CHAIRMAN KASS:  Do you want to respond, Gil?

PROF. MEILAENDER:  Just very briefly in terms of your question about, what if we simply asked what the person's current state is?  I mean, I think that's a good and a perfectly reasonable question to ask. 

But I believe, at least the formulation that I tend to use, that I would want to use in reply, is that I would say that I would want my decisions about what I did for that person to be based on whether there was anything I could do to benefit the life that person had, not on a decision about whether having that particular life was itself a benefit.

So I'm perfectly happy to think about their current condition, but even then I'm not prepared to make a judgment that they have a life that is itself not worth living.

DR. KRAUTHAMMER:  Well, the word "worth" I think is — is — it complicates, and I think it distorts.  If I'm in the presence of a loved one who is suffering and demented and can't act on their own, and the Leon event occurs, the Stokes-Adams attack occurs, I would be inclined to do nothing to end the suffering. 

It's not a judgment on the quality of life.  It's a judgment on whether — whether — it's not a judgment on whether it's a life worth living, that it's a matter of worth, it's a matter of humane fellow sympathy.  Would I want that — do I believe that a person ought to continue to suffer, which would happen if I were to rescue that person or not?

So I don't look — it's not as if — if you have a patient who's not suffering, but is incompetent, is essentially out of touch, I think that's a question of the value of life.  In the question of suffering, I think it's different.  It's not a question of worth; it's a question of the subjective experience.

CHAIRMAN KASS:  Well, let's stay with this exchange — I think this is fruitful — if Gil — if you and Charles would go one more round.

PROF. MEILAENDER:  Well, just a sentence in reply.  Obviously, I would — at least I would hope I would want to do whatever I could to relieve the suffering that that person was undergoing.  But I would not want to try to eliminate the suffering by eliminating the person suffering.

And there again, you see the question is whether what I'm taking aim at is the suffering or whether what I'm taking aim at is the person's life.  That's just another way of coming back to my same formulation, I realize, but that seems to me at least to be the boundary-making distinction within which, then, I want to leave as much latitude as I can for trying to make a whole range of decisions, and perhaps even for having people make different kinds of decisions.

DR. KRAUTHAMMER:  Well, then, if I could just add the one sentence, I think it's illuminating, because you would decide on that basis.  I would decide on the basis of the other rule, which would be that I would not actively intervene to kill under those circumstances.  However, in the presence of suffering, that was — I was not able to alleviate otherwise, I would allow nature to take its course in the event of a — of, say, a Stokes-Adams attack.

I think those might be two approaches of using a different set of rules to the same person.

PROF. MEILAENDER:  If I really thought that my moral obligation under those circumstances was not to intervene, so that the person would die and, hence, stop suffering, if that's what I really thought, then I hope I would have the courage to intervene more directly in order to end their suffering and not let them linger in it.

DR. KRAUTHAMMER:  And I would act —

PROF. MEILAENDER:  Because I don't think there's a moral difference.

DR. KRAUTHAMMER:  I would act exactly differently.  I would not implant the pacemaker.

CHAIRMAN KASS:  Robby, are you going somewhere else, or are you going —

PROF. GEORGE:  No, I just have a question about this, and it's —

PROF. GLENDON:  I think Robby is in a state of shock over here.


PROF. GEORGE:  Maybe puzzlement, because I'm with Gil; I don't see the distinction in — in terms of the intention, and, therefore, in terms of the morality of simply omitting to act or declining to intervene with the pacemaker and shooting them in the head.

DR. KRAUTHAMMER:  I think the reason for observing this line, or at least promulgating it, is a prudential one.  And that is that if you don't have the line, you will end up like — well, let's assume Holland is what we're reading about.  You will end up euthanizing people without limit.

I think the — look, we're having a discussion here in which we don't know where to draw a line.  We keep saying it's a matter of case after case.  I think a line has to be at least promulgated, if not a legal then at least a moral line.  And I think the distinction between active and passive is clear.  You're right that ultimately in terms of intent it's hard to make a distinction, but I think if you abolish that line then you've abolished all restraint on the euthanasia.

But I think if you were in the presence of such a case, I mean, it's easy to say, "Here, I would implant a pacemaker," I'm not sure how — I'm not sure you would, although I — if we're faced with the circumstance, I think there's an impulse in us to say there's no reason to impose endless suffering on — in a person in whom nature or providence has already intervened.


PROF. MEILAENDER:  Well, I don't know how to — how to make the point.  I would rather have the rule formulated, or the — just the boundary, the statement of the boundary, as it should never aim at a person's death, rather than your active formulation.

I grant you that your active formulation is much more conducive to — I mean, you could adjudicate it in a court of law, for instance, in a way that it's very difficult to adjudicate intention, and so forth.

But the reason I'd rather state the boundary the other way, not simply in terms of the active/passive distinction, is that I want us all at least to have to think about the fact that we might, on any number of occasions, deliberately seize occasions to get someone to die by not doing something. 

I mean, I want us to have to keep that moral question in mind at least, because, in fact, I think that at the moral level embracing the person's death as choice-worthy there isn't different... even though I grant you that in sort of public policy circumstances your rule is easier to apply.

But we need — we need to continue to think about and be faced by the fact that we might turn ourselves into people who are eager to seize occasions to get people to go away.

DR. KRAUTHAMMER:  If I could just add one thought.  The reason I would adopt it is not — the line I'm suggesting — is not only because it's easy to adjudicate and, of course, a law, but also because I have a sense that if I were the one who were the sufferer, and I had an attack of this sort, I would want no one to implant a pacemaker. 

So I am generalizing in sort of an act of human sympathy, if I can speak in those grandiose terms, from what I would want and what I would assume — starting with what I would experience and want, I'm assuming it would be an act of mercy on the part of anyone who was in that circumstance to deny me a life of further suffering.

PROF. MEILAENDER:  And if I were the person in case one, with the mild dementia and in need of the antibiotic, there is certainly a level at which I would want people not to keep me alive.  Okay?

DR. KRAUTHAMMER:  No, that's an easy call.

PROF. MEILAENDER:  Well, no, I — just in terms of what I would want, taking seriously Leon's comment about I know what's coming.  Okay?  There is certainly a level at which that's what I would want.

DR. KRAUTHAMMER:  You could talk about a 20-year-old person with depression and say you ought to listen to what they want.

PROF. MEILAENDER:  Well, let's eliminate the depression.  Okay?  Which is an underlying condition.  Let's just grant a rational deliberation.

The simple fact that I would want that doesn't settle the question of what I ought to want someone to do, or what I ought to do for someone else.

PROF. GEORGE:  Laying aside —

DR. KRAUTHAMMER:  And what decides what you ought to, if not that?

PROF. MEILAENDER:  Sound moral reasoning, which I have just offered.


PROF. GEORGE:  But have you?  Since if you're right, then — and by your being right, I mean, if it's right, if it's accurate to describe declining to go with the pacemaker as an act of sympathy and not an act of killing, then it would have to be also accurate to describe injecting him with a poison, shooting him in the head, as an act of sympathy rather than as an act of killing, even if as a prudential matter we would want in our medical practice and in our law to draw a distinction and to punish the latter, the active killing, and not to punish the omission or the passive, well, act of sympathy or whatever you want to call it. 

I mean, just in terms of the truth of the matter, laying aside —

DR. KRAUTHAMMER:  But that's precisely why I'm invoking two principles and two reasons.  One is sympathy, and the other is a prudential argument against erasing all lines and allowing unlimited actions of this sort.  Yes, if it were only sympathy, I mean, I can even imagine a case in which someone actively overdoses a patient in great suffering.

I'm sure it happens a lot.  It's probably written off as a double effect.  It probably isn't double effect, and I would appeal to my colleagues here as to whether I'm wrong — my medical colleagues — as to whether I'm wrong about whether or not this actually occurs.  I'm sure it does, but you don't want it as a rule and a principle.  You want to say it ought not be done, because once it's allowed, as in Holland, there is no end to it.

PROF. GEORGE:  I do understand the prudential judgment and the slippery slope argument.


PROF. GEORGE:  I'm just interested right now in the principle and the accurate description of the act.

DR. KRAUTHAMMER:  If it were only a matter of sympathy, yes, shooting would be allowed.  But it isn't only a matter of sympathy.

PROF. GEORGE:  No, no, not whether it's allowed.  I want to know, when we shoot him, are we doing anything morally different from what we're doing when we take advantage of the fact that he has just had the seizure and don't intervene?  Or when we don't put in the pacemaker, though we could, without — I take it, Leon, without great burden, right?  Without an extraordinarily burden.

DR. KRAUTHAMMER:  If someone is drowning and you decline to go in and save him, is that the moral equivalent of you drowning him in a bathtub?  Is that what you're saying?

PROF. GEORGE:  If the objective of my —

DR. KRAUTHAMMER:  I'm simply asking those — are they equivalent moral actions?

PROF. GEORGE:  It depends on the reason for the action.  But let's assume that the reason for the action in both cases is that he's my enemy and I want him to be dead.  Then they're the same.  If it's that I can't swim and would —

DR. KRAUTHAMMER:  I'm assuming you could swim.  Otherwise, it would be a lousy example.


CHAIRMAN KASS:  Alfonso, go ahead.

DR. GÓMEZ-LOBO:  I don't know if this helps, just a — one more effort to articulate this.  It seems to me that in cases of active euthanasia there is a necessary connection between that and the intention to kill.  In the case of omissions, surely there can be a connection.  They can be the sympathy intention.

But I do think it's contingent.  I think that there is room for omissions such that one can engage in the omission without the intention to kill, and that's the reason for Robby's question about burden. 

In other words, in certain parts of the world I'm sure that putting in a pacemaker is a huge investment and a big burden for the family, etcetera, etcetera.  And it seems to me that in cases like that, a possible interpretation would be that there was no intention to seize the occasion, that there was another reason for it.

CHAIRMAN KASS:  Let me try again.  Look, I'm — I'm very friendly to the morally scrupulous and high-minded arguments of Gil and Robby, and I'm very sensitive to the prudential worry of what comes when you start to open this up.  But I continually have this feeling that I'm being beaten around the head by morally superior reasoning, which flies in the face of common sense.


And so I think I know why you guys won't allow me to say, "Fellows, look, it's a new world — this world of mass longevity and 40 percent of it in frailty and debility."  And you can say, yes, it's true that we don't know the future, the future is — you could be run over by a truck before you can get the last stage of Alzheimer's Disease.  But this is a progressive disease, and in most cases it goes the way you know.

What's wrong with my saying to you — I've got two questions for the scrupulous.  One question is:  why is it that you are so quick to allow an exemption for a newly-imposed medical burden of the treatment, which is, after all, a burden to the life of the patient, but refuse to allow into consideration as an assessment what should be done, the burdens that the patient is suffering, that you haven't had?  From the point of view of existence, it seems to me, why — why make those distinctions?

Second question:  why is it — am I simply perverse when I say that there are some circumstances in whether — in which the true decision that you're making, whether you know it or not, is not a choice for death but a choice of which of the two paths to inevitable death you are forcing me to take, or inclining me towards, since there's no guarantee that I'm going to get to the end by either of these two paths?

And, in particular, what — well, that would be, I think, sufficient.  I could make it sort of vivid — in which you rescue or I rescue my spouse by putting in a pacemaker.  And assuming there's a next life, I can fully expect her to remonstrate with me in saying, "What kind of superior moral reasoning justified your condemning me to a decade of not being myself and of not having the kind of relation to my grandchildren that I want, rather than allowing me to live in the crap shoot of another cardiac arrest, which would take me off?"

What answer would I give to her as a result of having been persuaded by superior moral reasoning?

PROF. GEORGE:  Well, on the latter, I think you would say for the same reason that I didn't shoot you.  Or you could — you would have the same problem if the spouse in the afterlife said, "Why did you condemn me to 10 years when I asked you to shoot me?"

CHAIRMAN KASS:  I think there's a real difference here.  That is to say, look, I know we live in a new world, and those things can't be wished away.  But people didn't call pneumonia "the old man's friend" for nothing. 

There are these new things — there are ways in which — should the mere fact that I am in the clutches of a profession that can remove all of the immediate causes of death, can deal with all of these new episodes, enable those people to say that they will never somehow choose death and, therefore, they're not only going to rescue me when I fall on their doorstep — and, of course they're going to rescue me — but they're going to set up situations in such a way that I'm going to be compelled to live out this 15 years of degradation, some of which — I don't want to make it only in the future — some of which I am already suffering, and the intensity of that suffering I can see.

I'm not somehow arguing for early surrender in every case or in all cases.  But there's something in me that resists the claim that this sound moral reasoning has to govern here for the right choices to be made, where you consider the full human significance of the life. 

And part of that is I don't see why you should privilege just the fact that this operation that you're going to give me is going to leave me with chest pain for a few weeks or the chemotherapy is going to make me vomit for a while, when I'm scratching myself to pieces or cursing the nurses or engaging in wild sexual activity with the other patients in the nursing home.  And that's a terrible thing, terrible thing.

DR. KRAUTHAMMER:  Could I ask Robby and Gil, are you saying that there are no circumstances under which you would ever withhold treatment of an incompetent patient?  Is that right?  Am I reading you correctly?

PROF. GEORGE:  No, that's not correct, Charles.  I thought that Alfonso explained —

DR. KRAUTHAMMER:  Under what circumstances would you withhold treatment that would lead to death in a patient?

PROF. GEORGE:  Where the burdensome nature of the treatment was such that it provided an adequate reason to withhold the treatment.

DR. KRAUTHAMMER:  So only if the treatment itself is worse than the suffering already existing.  So if I give you a case of an easy treatment, you would always say that as long as that treatment, in and of itself is not terribly suffering-inducing, there are no circumstances under which it should ever be withheld?

PROF. GEORGE:  I think there are no circumstances under which you would want to treat the life as the burden to be removed, as opposed to the burdens of the treatment.  So if there are no burdens to the treatment, and the only thing you're inviting me to do is to treat the life as the burden to be removed —


PROF. GEORGE:  — then I —

DR. KRAUTHAMMER:  Then your answer is yes.

PROF. GEORGE:  — say it would go with the treatment.

DR. KRAUTHAMMER:  And you too, Gil?  Always yes?

PROF. MEILAENDER:  Yes.  I have more to say than just that, but —


The important reason behind this is I think an attempt precisely to — to treat human beings equally, never to make judgments about — comparative judgments about people's lives, and it's, of course, true, as Leon says, that he — he wants to know why we'd be willing to refuse the burdens that come with the treatment, but not as it were to refuse all the burdens that already may come along with a life. 

And it's a pretty rational question; I don't — I don't mean that it's not.  But it's a question of what it is that I'm — I'm thinking it's permissible to turn against.  And I'm not going to turn against your life.  I'm going to do whatever I can to benefit the life you have.  It doesn't mean that one must take any and all burdens that come along. 

I think the point is that — that at different points in life there are a different range of choices, but we all have a range of life choices.  You don't have to choose for yourself, or even necessarily for others, always the longest life.  You may choose a shorter life free of certain burdens, for instance.  That's possible, from among those range of choices.  But we — what we don't choose for other people is death.  We don't view that as choiceworthy.  So that's something of what I'd say in response to your first claim. 

With — or your first query.  With respect to the second one, I do think you have an inadequate understanding of the afterlife, Leon.


All will be forgiven at that point, and you don't have to — you don't have to worry that you'll be under attack in that way.


CHAIRMAN KASS:  I'm looking forward to the judgment.


PROF. MEILAENDER:  But there are always — I mean, it's true that in keeping us alive at any point along the way medicine is predictably keeping us alive for potentially worse deaths.  I mean, I don't know how to get out of that.  It's a terrible truth about life, actually, that that's the case.

But that's part of — that's part of sort of sharing the burden of human life equally, it seems to me, and I don't — I don't think there's anything very good to be done about that, except endure it together as best we can.

DR. KRAUTHAMMER:  So you and Robby would outlaw all DNR instructions in all hospitals.


DR. KRAUTHAMMER:  Well, I don't want to prolong this, but I'm puzzled.

PROF. MEILAENDER:  Well, in the first place, are you talking — many people might request such for themselves, and we haven't — I presume that you're not asking about that.

DR. KRAUTHAMMER:  For all incompetent patients, you would not allow DNR to be written on their charts?

PROF. MEILAENDER:  No, not necessarily.  It would depend on the circumstances.

CHAIRMAN KASS:  We're going to wind up shortly.  If anyone wants a last comment after Mike, let me know now and —

DR. GAZZANIGA:  I think I win if I don't say anything here.


CHAIRMAN KASS:  I'm sorry? 

DR. FOSTER:  Let me make one last —

CHAIRMAN KASS:  Dan will go after you, Mike.  Dan will go after you.

DR. GAZZANIGA:  Okay.  You know, if there was only one person in the world, there wouldn't be all this talk about morality.  Morality starts when there's a group.  And so if you take this incident, this situation of withholding the drug or shooting as being morally equivalent, you're looking at it from the perspective of the person doing the pacemaker placement or the shooting.

If you're looking at the exact same situation from the viewpoint of the person with the disease, it's two completely different things going on — one, withholding of activity; two, murder, being shot by this person.

So it seems to me that you're conferring to the — to the person trying to help there two totally different mental states.  And so I find it very difficult to view this as a unique — I mean, as only one way to look at the moral action going on in this particular problem.  It comes — there's two different — totally different viewpoints that are at stake in this one act.

CHAIRMAN KASS:  Dan Foster, and then we'll take a break.

DR. FOSTER:  I only want to cite psychiatrist Prakash Desai that I have cited I think on one other occasion here when in the midst of theories of bioethicists I was the only — I'm not a bioethicist, but I happen to be the trustee of the thing, and he — we were talking about end of life decisions when that was the big, hot subject, you know, a few years ago.

And Prakash Desai, who is of Hindu — his faith is Hindu, said to us as a group — and I want to remind everybody here, because I think it's a powerful lesson to remember.  He said, "You Westerners have it all wrong.  Death is not the opposite of life; it is the opposite of birth." 

And this conversation has lifted up in some sense the idea that there is some — that death is something special in life, and, therefore, must be protected at all costs and as a consequence that to allow — in the extreme, to allow it to occur is not an acceptable thing for us to do.

Now I know that's an exaggeration, but what I simply want to say is that death is not the worst enemy in life.  It's not the worst enemy in life for anybody.  We hate it when it's premature.  We hate it when it's suffering.  But we need to keep into context that at the very least, in terms of the universe, we live maybe — maybe a femtosecond — I don't know, I haven't made that calculation — but, I mean, it is a tiny flash. 

And to have — you know, not to accept that, and just to say this is a natural thing and we ought to do the best we can to be kind, and so forth, and not to make mistakes of killing somebody prematurely, or something like that.  I just think we need to keep this in perspective, rather than the whole conversation as saying the end of life, where there's not — which entropy itself is going on, you cannot stop entropy. 

We're going to all die, and all of us want to die healthy, with an intact mind, and to die rapidly, but that doesn't happen to all of us, or for most of us.  And so I think one of the things — I don't disagree with a lot of the arguments that are made, but I certainly don't want to make this the key issue of what we've been talking about, that we must keep people alive for all time, whether there's — I hate to use the word, whether there's any meaningful life or not.

But if you can't tell that a life is meaningless, except in some hidden view maybe of the creator of the world, that there is some spark there, then you don't know what it's — you know, where they're defecating against — they can't move, they can't do it, you're paralyzing the family, and so if you can't tell the difference, then I wouldn't pay too much attention to a Ph.D. degree or — a Ph.D. degree or an M.D. degree or anything. 

If you can't tell the difference between that, then really you and I have no conversation to take place, I mean, because it just — it just makes you park aside, it seems to me, the sensory realities that all of us say are of necessity to make decisions.

That may have come out mean, and I didn't mean it to come out mean at all.  I just wanted to say — if you live all your life either in fear of death or thinking that death is the most important thing to prevent in life, then it's pretty hard to have a happy and a mature and a normal life.

If that was too mean, strip it from the — strip it from the —

CHAIRMAN KASS:  Well, no.  Let me make — use the chair to just make one comment.  I don't — I think it's possible to hear the arguments, say, made by Gil and Robby as sounding like a kind of mere vitalism, in which death is the ultimate and the only enemy. 

But the more I listened — and I think this is an important point for all of us to take away — it's not so much that death has always to be opposed.  It's that one should resist the temptation to put oneself actively against a life on the grounds that one knows and can take the measure of its ceasing to have sufficient worth to be here, and that it's sort of — it's not so much the judgment that — that death is the evil, but that there is an evil in ourselves that would come from, I think, making ourselves the judge and executioner of a life because of our judgment that it is somehow not worthy — fit to be amongst us.

I'm not defending their view, but I didn't think I heard — I think you made this comment in a similar point in the last meeting, and I think it was very well received.  I don't think there's a person in this room that would dissent from what you've said.

PROF. GEORGE:  Yes, that's absolutely right, Leon.  I think either individually —

CHAIRMAN KASS:  Maybe I'm wrong.  If they dissent, they should.

PROF. GEORGE:  Individually and collectively, I think Gil and I have spoken and written against every single one of the propositions you warned against, against the idea that death is the worst possible thing, against the idea that you must struggle to keep alive at all costs, against all of those things.

And I just — I'm not going to accuse you of being mean at all, but I — I do want to put in a — register a concern that you not hear people who think that we have very, very good, indeed compelling reasons to stick to the traditional norm against direct killing of innocent human beings.  Don't hear that as an appeal to vitalism or as to the idea that — that death must be opposed always and at all costs.  That's most definitely not what we're saying.  In fact, we've written against that view.

PROF. MEILAENDER:  We belong to a —

DR. FOSTER:  But in answer to Charles' questions, I thought I heard yes and yes.  Look, I've spent my whole life along the — you know, I mean, I'm violently against killing people and euthanasia, and so forth. 

But I heard towards the end, when Charles pushed both of you, that it came out that under no circumstance, except the person herself deciding for a DNR, that the answer was yes, yes, and there were no qualifications on it.  That's what caused me to say what I said.  It was unequivocal, yes and yes.

And if that's wrong, then I need to be corrected.  And I — I'm really pleased with what you said.  I obviously have not read everything that — you know, you've written about it, and I'm sure you have.

But that's what prompted me to say it was these two unequivocal yes and yes, and —

PROF. MEILAENDER:  Well, I didn't say that unequivocally.  I believe I specifically said in response to —

DR. FOSTER:  For somebody else to — if the patient —

PROF. MEILAENDER:  No, I started with that, and then I said not necessarily always.

DR. FOSTER:  Then, give me.  Okay, it's —


CHAIRMAN KASS:  Okay.  I think —

PROF. MEILAENDER:  One more sentence.

CHAIRMAN KASS:  The very last sentence.

PROF. MEILAENDER:  Just to add to what Robby said, we belong to a tradition that honors its martyrs.  We can't possibly think that death is the greatest evil.

CHAIRMAN KASS:  On that theological note, we will take a 15-minute break.  Five minutes to 4:00 we have a presentation from Frank.

         (Whereupon, the proceedings in the foregoing matter went off the record at 3:40 p.m. and went back on the record at 4:00 p.m.)


PROF. MEILAENDER:  Well, why don't we get started.  This is a session on biotechnology and public policy, the first of two sessions devoted to questions of regulation.  The Council has, since its very first meeting, had an interest in this topic.  It's, in fact, an interest that we have followed almost throughout our entire course.

And the question — the large question that underlies that — those discussions and inquiry is:  can we find ways to govern for the good the uses of these novel and challenging biotechnologies, repeating their benefits while at the same time upholding human freedom and dignity.

We've issued a report on this subject, Reproduction and Responsibility.  It is, in important respects, an interim report.  It was primarily a diagnostic document, though we did make recommendations in the interim, while suggesting that the conversation had to continue, about which of the various possible regulatory models might be most fruitful.

And we have today and tomorrow morning two sessions that constitute part of this Council's continuing inquiry into that topic.  Tomorrow morning we are very fortunate to have two members of the Canadian government — Health Canada, Ian Shugart and Glen Rivard, who are here today — welcome to you — and they will tell us tomorrow about the very interesting new system that Canada is instituting following legislation passed earlier this year. 

We heard something about this way back from Patricia Baird, who was part of the original commission that was looking into this.  But these gentlemen have had a hand in actually getting the legislation through and implementing it.

Today we are privileged to have a presentation from Frank Fukuyama and his colleague, Franco Furger.  Welcome, Franco.

Frank, more than any other member of this Council, has been devoted to this subject.  He is in a way the spark and the father of our inquiry.  I think everybody knows that he has also, with support from foundations, been conducting his own seminar over at Johns Hopkins.  I and several members of the staff have been privileged to sit in on these meetings.  As Frank will tell you himself, this work is the work of the two of these gentlemen.  We present it here not because it represents the thinking of this Council but because it represents important thought that should be brought to this Council.  And we hope that the conversation will help your project and that this presentation will help us in continuing to think about this.

So the floor is yours, and thank you very much.

DR. FUKUYAMA:  Well, thank you very much, Leon, for giving us this opportunity to talk about our project on biotechnology regulation, and we appreciate you and the staff attending our meetings over the past 18 months.

The presentation we're going to give you today is going to be a little bit different than the slides that are in your briefing book.  We are going to skip over the description of the existing regulatory framework, because that was actually quite adequately covered, excellently covered in the Reproduction and Responsibility Report that the Council issued.  So I think you are quite familiar with a lot of that.

We do have an Executive Summary of about 25 pages.  If Council members would like to see a copy of that, we will be happy to give it to them.  We're not releasing it publicly at this point, because we wanted to get comments from our study group first and incorporate them. 

I hope within the next month we'll actually have something ready for public release, and the full body of the study is really a massive — it's really more of a book than a report, several hundred pages, that covers the regulatory waterfront quite exhaustively.

I would like to pay special thanks to Franco Furger, who is seated to my left.  He has really been the driving force behind this project.  He has drafted most of the report, and the real research and work of putting together both the study group and the report itself are really — are really due to him.

It's entitled "Beyond Bioethics," because it was our feeling for some time that the model that was settled on in the 1970s where the scientific research community and certain areas of biomedicine were left largely self-regulating, with advice from bioethicists on the ethical dimension was no longer adequate to meet the demands of the technologies, the ethical challenges that the technologies would put forward, and that we needed to talk about the R word, the regulation word, much more explicitly.  And that is really the subject of the talk today.

Go ahead, Frank.

Now, the project has been running for the past 18 months.  We've had a series of about 11 study group meetings involving — not all of these 39 members came to every meeting, but we tried to get all of the major stakeholders that had an interest in the broad area of biotechnology, reproductive medicine, from, you know, the biotechnology industry organization to members of the President's Council, and a lot of scientific groups representing scientific research communities of various sorts, and the like. 

If you are interested, we also have a website and a regular newsletter that reports basically on regulatory and legal issues related to human biotechnology.  And you can sign up for the newsletter.  You'll get it automatically, or you can go to our website.

The study group members are being asked to comment on the report, but the — when I say "we" in the subsequent presentation, the "we" just refers to myself and Dr. Furger.  The members of the study group were not asked to actually endorse the contents of the report.

Go ahead.

This is just a screen shot of our website.  It's quite involved.  It really has quite a lot of sections, so I really do invite you to — to take a look at it.

Okay.  Go ahead.

This is an overview of what we're going to be talking about this afternoon.  We're going to define the domain of inquiry, say a few preliminary things about regulation.  We are going to talk about the ethical principles that motivate the desire to regulate, and then we're going to — actually, we're going to drop out most of that last point, regulation in other developed countries, except to talk very briefly about Britain and Canada.  We'll obviously hear much more about Canada tomorrow morning.

And then, finally, pros and cons of alternative approaches, which range from basically the status quo to creating a new regulatory institution.  We opted for the option of a new institution, but we really did want to try to be judicious in our consideration of different kinds of approaches, and then to define what a new institution might look like.

It is basically an independent agency, of which there are many scattered around Washington, but we believe that we need some innovation in incorporating new mechanisms for public participation.  So we will describe this in much greater detail.

Incidentally, this is, you know, in a way an issue that all regulatory bodies, both national and international, have been struggling with, because there's a feeling that the old mode of top-down formal regulation is not adequate to meeting the — you know, the demands of kind of popular participation and the solicitation of kind of ownership by the people in the society, the broader society that the regulators effect, and so it comes up in a lot of different contexts, not just in this biotechnology one.

And, finally, we're going to say very briefly something about constitutional constraints and some international considerations.

Now, the domain of inquiry is very similar to the one that was defined in the Reproduction and Responsibility Report.  It's technologies and medical practices related to human reproduction, not necessarily those that had the intention of producing a child, but ones that were related to it, and that includes several areas — the practice of medicine involving artificial reproductive technologies, ARTs. 

But it also includes scientific research in the area of stem cells and research cloning.  Obviously, stem cell research does not aim at reproduction.  But since the embryonic stem cells come from embryos, it obviously is related to the whole area of reproduction.  So our interest is in covering that.  I don't think you can really separate the two of them out.

And just to indicate the kinds of technologies we are talking about, it's things like prenatal genetic diagnosis and screening, reproductive and research cloning, if germ-line modification becomes possible in the future this would fall under this category, novel forms of reproduction of the sort that were mentioned in the Reproduction and Responsibility Report, you know, the fusing of embryos, the walking back of, you know, adult stem cells to oocytes, a lot of the things that seem to be in the pipeline right now.

Now, we thought that we ought to lead with this, just to clarify where we're coming from on this topic that we and this Council have discussed at great length in earlier years.  Obviously, it is very difficult to talk about regulation without getting past the issue of the status of the embryo. 

I think that the — the controversy over this may well make our effort difficult, if not impossible, to actually accomplish in this society.  And as you'll see, I think it will require a prior consensus on resolving this issue.  But just to put our cards on the table, we start from the position that's been defined in this Council as one of, you know, believing that embryos have an intermediate moral status, which means that we believe that both embryo and stem cell research are legitimate activities and can be done.

What to me "intermediate moral status" means is that embryos do not have the moral status of infants, but they are also not simply clumps of cells, and need to be treated with a certain degree of respect.  And in our view, what that means, among other things, is that they cannot be disposed of or used, except for the most important and serious ends.  We do believe that stem cell research is one of those ends that is legitimate.

I would just make a — you know, an analogy.  I think there's another category of objects that have this similar intermediate status, which would be dead human bodies, cadavers, which are, in fact, instrumentally used in medical training and other things, but you cannot casually dispose of them.  We pay a certain degree of respect.

Now, I don't want to — I certainly do not want to provoke an argument over this.  I'm just — this is in the interest of full disclosure.  This is really our starting point and the premise with which we begin this regulatory project.

Go ahead.

Now, some general considerations about regulation.  I think it's quite appropriate to be very cautious about calling for excessive regulation, because whatever you regulate you obviously get less of.  And we, above all, do not want to stifle innovation and growth, and, therefore, we think that those that want more regulation ought to really demonstrate quite effectively why that is necessary.

On the other hand, I believe that in the current climate in the United States right now, if you actually want to make progress in something like stem cell research, it is extremely important to think seriously about the appropriate institutional regulatory framework under which it can be done successfully.

There's a clear example of this.  The British Human Fertilisation and Embryology Authority is an extremely strict regulator of embryo research in the United Kingdom.  Every embryo that is produced in any fertility clinic in Britain is tracked and registered by the HFEA.  So it's a much stricter regulatory regime that exists — than certainly the one that exists here in the United States.

On the other hand, it is perfectly compatible with a vigorous stem cell research effort in Britain.  Britain is one of the leaders in this area, and I would argue that if the United States wants to be a leader it — it needs to do that also.

I mean, it needs to give serious thought to the regulation, because the regulation will present abuses happening that are consequentialist abuses of the — I mean, if you think that stem cell research is legitimate, but you are worried about the further, you know, moral slippery slopes that come from it, I think that you absolutely need a regulatory framework to put some firewalls against those kinds of possibilities.

I'll just give you this brief analogy to what we think we're doing, or the kind of juncture we think we are at historically.  In 1887, the Interstate Commerce Act produced the Interstate Commerce Commission that existed up until I think 1995 or so, which was to regulate railroads in the United States.

The Hepburn Act, in 1906, gave trucking regulation to the ICC on the grounds that trucks simply moved goods over state boundaries just the way railroads did.  And I think most experts in administrative law felt — have felt in retrospect that that was a really big mistake, because the economics and the politics of trucking and railroads were sufficiently different that the expertise did not transfer over.

And, therefore, when civil aviation came into being in the 1920s, the United States did not give civil aviation regulation to the ICC, which conceptually it could easily have done.  It created agencies that eventually became the Civil Aeronautics Board, and the Federal Aviation Authority, too, as new, independent regulators.

And that's really our argument.  I mean, you could use the existing regulatory system in the United States to carry out some of these tasks.  But it is our view that given the narrow mandate of the Food and Drug Administration and the National Institutes of Health, we do not think that that is an adequate basis of doing this.

Now, in your briefing books, you — oh, I'm sorry, we're not quite at that point yet.  All right.  Let's go ahead.

All right.  Now, this is — this next section is going to talk about the ethical principles that we believe motivate our desire to create a new regulatory institution.  Obviously, you can't say that you want to regulate something unless you have some idea of the goals or the goods that you are going to try to achieve. 

And so we're actually going to steal a page from the — you know, the Canadian approach to this that you'll see tomorrow morning and begin with, as they do, a statement of principles, although our principles are a little bit different.  And then, the principles generate a list of activities that we believe ought to be prohibited outright, as in the case of the list that was in the Reproduction and Responsibility Report, and then a series of activities that we believe are legitimate but need to be regulated.

General ethical principles — again, this will seem very familiar to members of this Council.  We put well-being and the health of children at the top of the list, above the right — we think that access to ART on the part of infertile couples is an extremely important social good. 

The million children produced by IVF have been, you know, a great blessing to those people, but we believe that the well-being of the children that are produced by this technology has a higher, you know, ethical status than the desires of the couples involved.  You know, many people would say that those are indistinguishable, because parents want healthy children. 

They want the best for their children.  And, therefore, what they want, you know, is a good proxy for the well-being of the children, but in our view that's not always the case.  It is largely the case, but there are many instances you can imagine in which the interest of the parents in having an offspring may outweigh the well-being of the child produced.  And by "well-being" we do not simply mean health in a kind of narrow physical sense.  We mean psychological and social well-being as well.

As you'll see in the statement of prohibited activities, you know, our interpretation, like that of the Council, of what "well-being" means, it means among other things being related to a — biologically related to a mother and a father.  And we believe that technologies that, you know, create children that do not have that relationship do not adequately take into account the — you know, the ultimate psychological and social well-being of the child.

The third principle, the well-being and health of women, is obviously important because there are certain risks that women take in artificial reproduction.  They are not borne by men in terms of need to — you know, for hyperovulation, and so forth.  But we put it below the first two principles simply because it's done voluntarily on the part of the women that undergo the treatment. 

And then, the next two are fairly self-explanatory — free and informed consent.  Again, as the Council pointed out in the R&R Report, you cannot have free and informed — I mean, you know, a lot of IVF, as it moves from the laboratory into clinical practice, really does amount to a form of human experimentation in which you can't really get the consent of the ultimate subject of that experimentation, which is the child. 

And it puts a special burden I think on information-gathering, and so, of course, the — you know, the R&R Report's recommendation for funding of better longitudinal studies of the health of ART children I think is really critical here and implied by that principle.

Finally, a principle that we would add is that we believe therapeutic overenhancement uses of biomedicine ought to be emphasized in any regulatory scheme.  Of course, you know, we've been through — since the Council wrote an entire study on this subject, we don't have to rehearse this.  But despite the fuzziness of the distinction in many cases, we think that it's still one that is extremely important to hold on to.

We don't believe that we need to ban or prohibit enhancement uses of biomedicine.  I don't think we would want to.  But certainly a regulatory system can bias things heavily in favor of therapy overenhancement in terms of the relative costs and the barriers over which you — that you have to overcome in proving the — you know, the safety of procedures, and the like.

Now, this statement of principles translates into several targets of prohibition — again, very familiar territory.  Reproductive cloning, creation of chimeras and hybrids, we — you know, again, as the Council did — make exceptions for certain, you know, research chimerism.  But we think that, you know, creating a chimera with an object of reproduction is something that simply should be banned outright.

Germ line, because we don't see any way that this can be done safely now or in the foreseeable future, again, the new reproductive possibilities that alter the biological relations of parents and children have to do with, you know, things like fused embryos or these new technologies coming out of stem cell research that would produce children that — you know, that did not have this relationship to a mother and a father, and then limits or a prohibition on the patenting of human embryos.

Now, the issue that would be regulated: we believe that we should permit research cloning, but that it should be carefully regulated.  Now, this is obviously a choice that many people would not make. 

I would point out that, as you'll see shortly, the difference between the British Regulatory Agency and the Canadian Regulatory Agency — in most respects they are identical institutions with very similar kinds of goals, but they differ in this one — on this one issue.

And you could create a structure of the sort that we are proposing that would actually prohibit research cloning, and would still do all of the other things.  So, in a sense, I don't want people to get too hung up on the fact that we believe that this is legitimate and simply subject to regulation. 

But we also clearly believe that PGD ought to be regulated, biomedical research involving early stage embryos, blastocysts, the kinds of things like limits on, you know, the stage of development beyond which research is legitimate — these kinds of issues — sex selection and commercialization of other elements of human reproduction.  We don't think that there should be a completely free market in the, for example, in the sale of gametes.

Now, we've skipped over — you'll see the slides in your briefing book.  We had some focus on the British and Canadian systems, but this Council has been over this.  This chart — in the full study, we have a comprehensive listing of every international piece of legislation in this area over the past decade or so.  It's an extremely long list.  This is just illustrative of some of the legislative initiatives that have been undertaken.

Four countries — Canada, Australia, the UK, and France — have actually set up new regulator — regulatory institutions in the last decade of the sort that we are proposing to do.  And virtually every other country, developed country, has passed legislation in this area.  And in this respect, the United States is a big outlier. 

We are really the only developed country that does not have legislation, for example, even on the narrow subject of cloning in place.  And many other countries have been considering this, so this is not an outlandish proposal.  It may be outlandish in the context of American politics, but certainly, you know, when we compare ourselves to even our Anglophone peers, we are very slow at working to this point.

Just very briefly, to give you a preview of what you're going to hear tomorrow about the Canadian system — again, this just emphasizes that the Canadian Assisted Human Reproduction Agency, this new agency that was just created by the Assisted Human Reproduction Act this year, sets up a new agency very much modeled on the British HFEA.

And they do very similar sorts of things, or at least they intend to do very similar sorts of things.  And, again, they differ in this one area: that the HFEA permits reproductive cloning — I'm sorry, there's a mistake there.  I'm sorry, under Britain, it's reproductive cloning permitted, not prohibited.  And Canada, reproductive cloning prohibited.  Yes.

No, I'm sorry.  No, that's right.  No, that's right.  They're both — I'm sorry, I was getting the wrong — yes, right.  The research cloning is regulated.  Sorry, okay.

Go ahead.

All right.  Now, we're going to run briefly over — I think we've got four major baskets of alternatives of how to proceed with regulation.   One is simply to use the existing statutory powers that exist in the FDA and NIH and the various state agencies. 

You'll see in the slides in your briefing book we go over all of the existing powers — I mean, you know, just very brief. Well, so that's one alternative — to take those existing statutes and reinterpret them creatively to give the existing agencies powers to do some of the things that we want to do.  That's one possibility.

The other is direct legislative intervention.  There are a number of cloning bills in — you know, that have been introduced into Congress.  There's a lot of state legislation in this area, including, you know, most recently Proposition 71 in California.  Self-regulation is an existing practice, but it is something that could be beefed up in many respects.  And then, finally, our preferred option, which is to create an entirely new regulatory authority.

Now, in terms of using existing powers, obviously it's hard to measure the cost of new regulation.  But if you go with the current system, you're clearly going to avoid a lot of direct costs of creating the new authority, and then the more important indirect costs of the opportunities forgone by the fact that you're limiting both scientific research and medical practice.

And the FDA has, for example, sought to regulate reproductive cloning by arguing that basically human embryo is a biologic that falls under their statute as something that they can regulate.  We think that there are a lot of problems with this approach, major gaps.  Again, people should be quite familiar with this.

The FDA, you know, only regulates drugs, medical instruments, and biologics.  And it's a lot of creative, I think, legal argument that says that an embryo is actually a biologic.  We have heard from quite a few lawyers that think that this would not really stand up to a court challenge.

And in that respect, you know, the NIH can — you know, in a sense has broader powers to regulate — on the basis not simply of safety and efficacy, and not simply those three categories of products. But also, you know, can make decisions on funding, you know, embryo research and the like, which it has done.  But it only covers federally-funded research, and really does not cover the private sector at all.

And, finally, there's an issue that Jim Wilson, among others has written, you know, very perceptively about in the past, which is that regulatory agencies that are created for one purpose not only have formal statutory powers, but they also develop a kind of bureaucratic culture that is oftentimes very difficult to change. 

And so if you give it a substantially different mandate, in this case the mandate to consider certain kinds of ethical issues in addition to safety and efficacy, a lot of times it's just very difficult for the — you know, the old institution to adapt to these new requirements.

Go ahead.

Now, direct legislative intervention. Obviously, Congress, if it passes a law prohibiting something like reproductive cloning, can speak much more authoritatively.  And I think it's important to point out that we would not — we do not believe that something like the status of the embryo, the moral status of the embryo, is an issue that can be delegated to any regulator.  That's obviously a very controversial and important ethical issue.  It needs to be decided by the society and not — not delegated.  And when Congress does speak, you know, we know, really, where the American public stands.

On the other hand, we believe that in the future there are going to be lots of very tricky decisions that will be put forward by new developments in technology that Congress simply does not have the expertise or the time to legislate specifically on. 

And even if they were to legislate, we don't believe that this is a good idea, because, you know, this kind of direct legislation is too — you know, it's a big hammer, and you need, I think, a more delicate instrument to make some of these kinds of decisions.

For example, the current cloning bill, just as an example of the inadequacy of the current direct legislative proposals, the S. 303 is a bill that was put before the Senate that would ban reproductive cloning and permit research cloning, human embryonic stem cell research cloning. 

But we believe that if you read the bill carefully, it is completely inadequate in terms of the regulatory oversight that it — it provides.  It basically says that any new protocols have to be given to an IRB.  And for reasons that we detail in our longer report, IRBs currently, as set up, are simply not capable of making decisions adequately here.

Proposition 71 is even worse.  I mean, this was a proposition that was deliberately designed to strip out as many institutional constraints on scientific research as possible.  I think it's safe to say it's kind of like turning over the henhouse to the foxes in a certain sense in terms of the governance structure.

And so what we're trying to do is — is think through seriously, if you didn't want to do that, what would a regulator look like?

Go ahead.

Self-regulation — this exists right now.  ART is self-regulated by ASRM and SART, the two major associations that represent the ART practice of medicine.  And, again, this is repeating stuff that was in the R&R Report.

We really don't have enough information in a certain sense to know fully how effective it is.  Certainly, there are limits to what self-regulation can do.  The other thing that's important to note is that there is no clear dividing line between regulation, formal regulation, and self-regulation.  All formal regulation ultimately requires cooperation, substantial cooperation, on the part of the regulated industry.  That's where all the knowledge of what's going on comes from.

And in many ways, the most effective forms of self-regulation operate in the shadow of the possibility of formal regulation.  And so I don't think that it's sufficient to, you know, simply throw up self-regulation as a clear alternative to a more formal structure.

And, finally, our choice for the reasons stated: in order to incorporate ethical decisionmaking or ethical considerations into the regulatory decisionmaking, we believe that you really need a new institution. And also one that will deal explicitly with the question of interest group capture and deadlock.

And, again, you know, the flip side of this is the pros of sticking with the current system, the opportunity cost of creating this new institution.  Now, we're going to go on to talk about what that might look like, if we did number 4, alternative number 4.

Our proposal is modeled on both the British and Canadian authorities.  The central design criteria is the need to avoid capture of the agency or of the polarization within the agency between various single-issue interest groups, so that it will simply not, you know, serve the interests of, let's say, the biotech industry or the — you know, the ART practice of medicine.  It cannot also be held up, you know, simply by — by pro-life groups.

Now, the rationale for doing this is really based on our understanding of where the American public is as opposed to the interest groups.  You know, there is a — in the discussion of public choice, there's this kind of debate over what constitutes the public interest.  And for many people, public interest is simply, you know, all of the existing well-organized interest groups that show up at a public hearing. 

And for reasons that we will detail in the next few slides, we do not believe that this is an adequate approach, because we think that the existing interest groups, particularly in this area, actually are not representative of the American people at all.  They are much more polarized and represent a much narrower set of views than the American public generally.

And, therefore, we take a new approach in which we give statutory power to a new independent agency that will be constituted to be able to incorporate this kind of ethical decisionmaking. 

Obviously, it will be based on the expertise and with respect to the scientific researchers and the — the — you know, the biomedical practice in reproductive medicine, but will also reflect broader societal concerns.  And, therefore, it is very important in the design of this agency to have new mechanisms to encourage public participation.

We think that the current deadlock over cloning, in which there is, you know, general agreement that we want a ban on reproductive cloning, but are very divided on research cloning, which has then prevented the emergence of any legislation whatsoever, represents a kind of political failure in this country that other countries have not been subject to. 

And we think that this actually does not reflect the interests of the American people, as far as we can tell, through empirical evidence.  And to demonstrate this, if you look at — and we cover a great deal of polling data in our study — if you look at what the American public thinks about research cloning, they are not terribly sympathetic to it in the way that the scientific research community is.

For example, if you poll Americans with a kind of neutral formulation, in which you balance the rewards from research cloning against the fact that you are destroying embryos, basically you get a two-to-one opposition. 

And, obviously, you can stack the results of these polls depending on the way you ask the question.  So if you talk about the benefits, you get to a 50/50 split in the American public.  And if you mention only the destruction of embryos, you get much higher opposition.

But the balance formulations really lead to general opposition, which means that the American public is really not at all where the scientific research community is on this issue.

Go ahead.

On the other hand, if you look at something like stem cell — embryonic stem cell research, using excess embryos, I think it is very clear that there's a very large majority of the country that is in favor of doing this.  You look at the Harris — the first Harris poll for 2004, 72 percent of Americans support this kind of research, and only 13 percent are opposed to it.  And that — you know, and public opinion has been moving in that direction as we have debated this issue.

And, therefore, the current policy is not one, you know, at least according to this poll data, that is generally supported by the public.  And what this I think is meant to illustrate is that, in fact, the current polarization that exists in Congress and in the debate on the part of the interested, organized groups, is actually much more polarized. You know, the American public occupies a much more centrist position, and I think one that would actually support our proposal to permit, for example, stem cell research, but under strict regulation. Much more than actually any of the existing positions.

All right.  So the problem of institutional design is to make the institution both independent and representative, and I suppose you should add effective, and capable of making actual decisions. 

So we have a kind of two-tier approach to doing this.  The actual power to make decisions will be vested in an independent agency.  The way that these are designed, you know, comes down to things like appointment terms and voting rules.  In many independent agencies, the President appoints members of, you know, the agency or commission.  They serve for fixed terms.  They have to be approved by — you know, by the Senate.

We have a detailed discussion, which, you know, we can discuss at greater length if you want in the question and answer session about how we think we ought to approach the creation of the board of this agency.  But our view is that it should not simply represent the existing groups, that we should — you know, that the President ought to use his discretion in this to seek as many independent commissioners that are not clearly associated with — you know, with that approach.

The second tier of this is an advisory function that has to do with mechanisms for public consultation.  Now, existing administrative law provides for this already, and it's built into a log of regulatory agencies.  The Administrative Practices Act from the 1940s provides for notice and comment, which is, you know, routinely done on — when an agency wants to promulgate a new regulation.

We think that this is not really an adequate, you know, approach.  Generally speaking, agencies, by the time they post a rule for notice and comment, have already actually gone through a consultation process with a lot of the stakeholders, and very little tends to happen as a result of the — the public input at this point.

Again, public hearings are built into a lot of decisions on, you know, things like toxic waste management, you know, nuclear — sighting of nuclear sites and the like.  And, again, the actual empirical record of public hearings having, you know, major impacts on — on decisions is — tends to be limited.

There are some newer mechanisms like consensus conferences and citizens' panels.  A consensus conference is a relatively small group of citizens that are chosen to be somehow, you know, broadly representative of the public, who actually sit — they are given information, they are brought up to speed on the nature of the technology — and then they sit down in a small group and discuss that, and try to come to a — you know, a decision on, you know, what the appropriate regulatory response ought to be.

It's an interesting procedure.  It's used in — you know, in the United States.  I guess the NIH has used it in environmental law, and other places.  It's used very extensively outside the United States, in Denmark particularly, in Japan, in Switzerland, in other countries.

The big problem with this is that if you empanel, you know, one — one consensus conference of 20 citizens, you have to wonder, even if they come to a consensus decision, you know, what that represents, because, you know, it's just 20 citizens.  And so, but it is something that has been used in rulemaking in — you know, in other cases.

And there are lots of precedents, you know, for — for all of these measures — public participation measures.  At a federal level, most of these are in the area of environmental law.

Go ahead.

We believe that we really need public participation as a buffer against interest group polarization, but that then represents — you know, raises a question of who should you consult, or who are the real stakeholders?  And as I said, many people — the answer to that would be, "Well, whatever interest group simply shows up." 

But, you know, there's been a lot of writing on the participation of NGOS and interest groups in this kind of regulatory decisionmaking.  I mean, it exists both at a national level and at an international level where there are all sorts of proposals.  You know, the UN already incorporates a lot of this sort of thing, of consulting NGOs and their various proposals to have this incorporated into WTO decisionmaking.

It is very problematic in a lot of respects, because NGOs, you know, claim to represent the public good. But they — you know, they may or they may not, and they're not accountable.  They do not, you know, have clear rules.  There is no way of knowing whether the interest groups that actually show up are, in fact, broadly representative.  There are plenty of cases where you get very good decisions, regulatory decisions, that are nixed by a very unrepresentative NGO that just happens to be very well organized and together.

And so we — you know, we think that this is not an adequate approach.  And so, therefore, in a sense we need public consultation, but one that has to be much more, you know, guided in a sense, you know, to avoid — to avoid that kind of problem.

There's a further problem in this particular area of scientific literacy, because, of course, there are big problems with simply how much the public knows about, you know, particular issues.  You know, it turns out that people don't understand the difference between reproductive and research cloning, and the like, and then they change their attitudes once they discover what — you know, what the difference is.

And so, obviously, you know, to say that you're going to consult the public means that they have to have a certain basic, you know, degree of information about the technology.  And then, finally, you would like the consultation to be deliberative, so that it's not simply polling existing, you know, strongly-held preferences, but in a way the shaping of preferences through a kind of discussion.

Again, there are problems with this, because sometimes deliberation doesn't lead to consensus.  It actually leads to greater polarization.  I don't know that there's a clear institutional solution to this, but it is a danger of this approach.

So this is our proposal, I guess in a nutshell.  The independent agency structure to require — I guess there are constitutional constraints on whether the statute can actually require this kind of balance, but certainly it would be a recommendation to the President in terms of the appointment of, you know, the Commissioners to achieve a kind of balance and independence on the part of the Commissioners.

And then, public participation mechanisms — and this is the part that I think really is new and does not exist in any existing regulator in the United States right now — deliberative panels. For example — essentially, what it does is take a — a consensus conference, and simply multiply it. So that instead of having one consensus conference, you may have, you know, a couple dozen or even larger. 

I mean, there have been cases that have been sponsored, you know, not — not in terms of government rulemaking, but in other areas, where you empanel a lot of panels that are designed to be, you know, much more broadly representative by the usual criteria of geographic representation, age, gender, occupation, socioeconomic status, and the like.  These can be supplemented by various forms of targeted surveys.

We think that, you know, the internet and new forms of technology — communications technology, give you also certain other opportunities for public consultation.  That's what the consultative college refers to, which is instead of bringing people together and empaneling them for, you know, in effect a town hall meeting, you can have kind of ongoing discussions that, again, will have to be carefully managed by the agency, but with the purpose of eliciting both deliberation and, you know, solicitation of public views.

Go ahead.

Constitutional constraints. I mean, I think the issue has been brought up by a number of people that if we actually wanted to create this kind of agency, it may fall afoul of some constitutional issues having to do with procreative rights. 

We don't believe that this is the case, because we think that the courts are likely to recognize a much more traditional understanding of any right to any procreative rights.  We certainly would endorse a fairly modest interpretation of that.  And I think that, you know, the more — I mean, there are law professors that have argued that, you know, there's a constitutionally protected right to use ART for reproduction. But we think ultimately that this will not be a barrier.

The final — go ahead.  The final slide simply has to do with international considerations.  These are issues that have been already debated in the United States at an international level.  There are various, you know, approaches to that, but we basically think that this is not the time for any consideration of international regulation.  Until you have national rules being created, it is very, very premature to talk about any type of international agreement.  And in any case, I doubt very much that you are going to — you are going to get it. 

So that is our proposal, and we welcome — we are in the process of working it.  We solicit, you know, reactions, and we hope to be able to actually publish the document, both the Executive Summary and the longer version of this, sometime in the spring.

Thank you very much.

CHAIRMAN KASS:  The floor is open for discussion.  Jim Wilson, please.

PROF. WILSON:  Frank, you and your colleagues have done, as I would expect, an admirable job of summarizing what needs to be done.  And as you know, I agree with you that a federal regulatory agency is necessary, and I agree with you that research under carefully regulated conditions on embryonic stem cells should not be barred.

My concern is with the structure of what you have suggested.  If you look at the history of federal regulation across a variety of areas, we've had essentially two strategies.  One is summarized by the ICC, the Federal Communications Commission, the Civil Aeronautics Board, the National Labor Relations Board, the Securities and Exchange Commission, all created to represent interests.

And then, we have a different strategy of single-headed agencies — the Occupational Safety and Health Administration, the Environmental Protection Agency, the National Highway Traffic Safety Administration, and others.  And as a generalization, admitting of some exceptions — I'll put the Food and Drug Administration aside, because it doesn't fit any of these generalizations — the commissions have failed, and the single-headed agencies have succeeded. 

And I think the reason for that is that you can hold somebody accountable in a single-headed agency.  And if you don't like what the EPA is doing, or OSHA is doing, you know who to investigate, and you know who to publicize. 

Secondly, we have learned from experience that when the President makes appointments to commissions, he will appoint the obvious stakeholders.  And in the case of the ICC, he appoints railroad operators, and occasionally truckers.  In the case of the CAB, people close to the airline industry.  In the case of the FCC, people close to communications.

The National Labor Relations Board is a bit different, because Democratic Presidents appoint union members, and Republican administrations appoint conservative members.  So the NLRB is the most frequently sued regulatory body in the United States, because it has a built-in degree of conflict.

So that though I am in favor of some degree of consultation, I might not go far as the deliberative panels, because they might exhaust this country's limited capacity for consultation.  I wonder if you have good reasons for having rejected a single agency head in favor of a commission?

DR. FUKUYAMA:  No, I'm glad you brought that up.  No, we are really not — that's not fixed in stone.  And, in fact, when we presented it to our study group, Ernie Gellhorn, who is a fairly prominent expert, legal expert, in public administration regulation, actually made exactly that point: that the single-headed agencies are usually much more — I mean, apart from the — you know, apart from the politics of the appointments of independent commissions. He also pointed out that they are much more effective, because you don't have to get a board of regulators to all agree on something, and get deadlocks, and so forth.

We had started out with this idea of a — you know, of an independent commission, you know, simply because that was the British model.  They've got 17 commissioners.  But I think that that's a kind of — you know, that's the sort of useful comment that I think in the specifics of the design we are looking for, because there does seem to be a, you know, strong opinion that a single-headed agency is a — you know, is a better way to go.

CHAIRMAN KASS:  Before I simply let people get in the queue to make comment, let me make an observation that might guide the discussion.  This group — it is well-known to everybody — is divided on the question which Frank, for his own proposal, stipulated. Namely, judgment on the moral status of the embryos, such that certain kinds of research would be licit, if regulated — a principle which is not universally shared here.

And when we discussed the question amongst ourselves, it was perfectly clear that — at least as I remember Gil putting it, he would be delighted to support a regulatory agency, provided he could choose the principals and name the members.

And there will be people for whom this proposal is noxious because of that particular fundamental question. And Frank has as much acknowledged the difficulty of trying to get this proposal a public hearing in this country by virtue of the national division on this.  It may be more polarized than the Congress as a nation, as a whole, but who knows until one tries.

I don't want to silence anybody who wants to raise principled objections to the entire enterprise on those grounds, and I would cede the floor to you.  But it would be, I think, useful to Frank, and also useful to us, for the sake of reflection to — because it seems to me it's possible to design such a thing in which embryo research was not the central piece of this.

So it seems to me we have an opportunity to hear — here to think about the question of how, if one wanted to try to practice regulatory activity in this area, knowing the problems of polarization, and knowing the problems of capture by the regulated, what are the ways to think strategically about how to do this — I mean, how to do this well?

Jim Wilson's first comment starts along those lines.  And I would at least like to make sure we reserve a significant portion of this time treating — sort of stipulating with Frank his assumptions — and then trying to think through the mechanism, including questions of the degree of public participation, where this should be located, and things of that sort, knowing that there are at least a significant number of you who were lost in this proposal by the second or third slide, whenever it was, and this proposal may be lost to America for similar reasons.

But it seems to me that if we're really thinking about this, that we should try to enter into the discussion in the spirit of a proposal as offered.  People are obviously free to dissent even from that chairman's suggestion, and anybody can say what they wish.  But that, I think, might be the most — it is a new thing for us to try this out.

Alfonso, please.

DR. GÓMEZ-LOBO:  Of course, I am a voice dissenting here, but I won't repeat the arguments.  What I really need is something like education in American constitutional law, or something like that.  And the reason is this — Frank, you extol the HFEA, and, to be very frank, I'm rather appalled by the HFEA. 

I remember when we had representatives here one person was heading the — the Authority, and I was appalled at the lack of reflection on the moral issues.  And you mentioned several times that there were going to be ethical issues decided by this Authority. 

So the first thing I would like to know is:  what's the point of giving this huge responsibility to a body that's going to be appointed on — I'm not sure on what grounds.  I mean, representative — you know, you gave us some leads.  But if I were appointing this Authority, I wouldn't know how to appoint it.  Probably it would end up being appointed according to political variables.

But let me go to the — perhaps the deeper issue.  I'm sure there are sensible analogies with the ICC, the FAA, etc.  But unless I'm totally wrong, none of those regulatory institutions deals with something as basic as this.  I mean, we're really dealing with human life, with the decisions, you know, life and death decisions pertaining to early stages of life.

Now, even if we grant this, what I'll call "intermediate status," which I've never understood, and you're going to have a give me a very, very detailed explanation and argument for the status and when it ends, etc. But are we talking here about something that traditionally has been directly in the hands of the state, of legislation, of the courts?

I mean, traditionally, the state is the warrantor of human life, is the institution that we, as human beings, have to protect such basic things.  And then, of course, we go to court or there's also penal law for breaking — you know, for having these basic goods.  So I'm just not sure — why delegate such important decisions that should be in the hands of the community as a whole through the Congress, through the courts?  Why delegate that to, you know, 17 members?

Thank you.

DR. FUKUYAMA:  Well, Alfonso, we'll have to have the discussion about "intermediate moral status" offline I think rather than in the — in this session.  I would simply say that right now, given the nature of American law in this area, you have delegated decisionmaking in this area to the market.  I mean, that's the only constraint that exists now.

If an IVF clinic, you know, wants to fuse two embryos and produce a child, bring it to term, that has four biological parents, there's no legal restraint on that.  There's no legal restraint on reproductive cloning.  There is no legal restraint on, let's say, taking a man's adult stem cell, walking it back to an oocyte, you know, having that oocyte, you know — I mean, having the man then be the mother of a child. 

There's no legal restraint on harvesting a fetal egg, producing a child that, you know, basically has an unborn mother.  I mean, all of these things — you know, nobody is doing that right now, but when you say, well, you know, the state ought to take a position on this, the fact is we don't. 

And so this is, you know, our attempt to say that these are extremely important issues, and we should not leave it up to the market simply to decide on whether this is legitimate or not.  And we, in fact, ought to create, you know, a mechanism by which the American public, through a kind of structured, you know, set of procedures and institutions, ought to decide whether we actually want this thing to happen.  And I guess that's the simplest answer.

CHAIRMAN KASS:  Also, by the way, just — there was a slide of some importance on part of this that I think I'm — if I'm not remembering, Frank did say that some of the very large issues were not to be delegated, but had to be decided through national deliberation, such as the question of, well, what gets called the moral status of the embryo. And that some of the larger issues in value terms would be set nationally by legislation, leaving the more specific narrow questions to the Commission or to the panel, if I'm not misremembering.

DR. GÓMEZ-LOBO:  A very brief followup.  What you say is very persuasive, but it seems to me that that's precisely an argument for legislation in the area, not for the creation of an Authority.

DR. FUKUYAMA:  Well, obviously, the creation of this Authority would have to follow on a decision.  For example, even in the more — the most minimalist understanding of what — what's permitted, you know, you do embryo research on spare embryos.

Now, as I said, the poll data seems to show that there is an overwhelming majority of Americans that — that actually favor that.  But Leon is right that our large institutions, meaning Congress, will have to decide, you know, on the legitimacy of that, and say that this is something that we as a country want to do before you can even begin to contemplate building, you know, a structure like that.

The kinds of delegated decisions that our agency would take would not be that one.  It really would be smaller kinds of issues.  For example, you know, we had this principle about chimerism.  But as we, you know, saw when we briefly touched on this issue, you know, scientists create chimeric, you know, tissues all the time. And is that legitimate or not? 

And, you know, at what point does it begin raising, you know, some delicate, you know, ethical kinds of issues?  I mean, that — I don't know whether that's the best example of this, but there are, you know, other kinds of complex decisions, or the sorts of things that the HFEA has actually, you know, passed judgment on it.  Is it legitimate to create a child simply to provide bone marrow for a sibling?  You know, that kind of issue.

And I just don't think that Congress has the capability, the time, the interest, or the inclination to pass a law saying whether that's legal or illegal.  I think that that is, you know, preeminently a kind of decision that ought to be made by this kind of an administrative agency.

CHAIRMAN KASS:  All right.  I have Gil, Mary Ann, myself, and then Mike.

PROF. MEILAENDER:  Frank, a question, just a structural question.  When you were going through the — you had several things on the pros and cons of the alternative approaches, and the first of the alternative approaches was to use some sort of existing way of dealing with it.

In two of the cons, there were "inadequate public participation" and "hard to change bureaucratic culture."  But those don't return in relation to your own proposal.  And I wondered whether they ought not return in some ways.

In terms of inadequate public participation, if I understand — now I wasn't sure, and you were going fast I know at the end, I wasn't sure if I understood correctly, but the one thing that you're adding is the consultative college, which almost sounded like an internet undertaking?

DR. FUKUYAMA:  Well, that part of it would be that.

PROF. MEILAENDER:  Okay.  I mean, if that's it —

DR. FUKUYAMA:  No.  And the deliberative panels — I mean, a large number of deliberative panels, which are basically, you know, structured town hall meetings where you'd have to give a lot of thought to, you know, balance in terms of representation and who's invited. Aand they would be deliberative, you know, empanel people to discuss these issues for, you know, a couple of days to —

PROF. MEILAENDER:  Didn't you say that some of that already occurs in other contexts?

DR. FUKUYAMA:  Yes.  I mean, you'll have some agencies that will empanel one group to do this.

PROF. MEILAENDER:  Okay.  And you're just going to do more of it, is what you're saying?

DR. FUKUYAMA:  We're going to do much more of it, yes, to make it much more representative —


DR. FUKUYAMA:  — and —

PROF. MEILAENDER:  Okay.  Well, I mean, at any rate it seems to me there are some questions to raise there.  And then, granted, there wouldn't be a bureaucratic culture in place, because you're creating something new.  But wouldn't it very quickly develop a bureaucratic culture? And a bureaucratic culture precisely about some —

DR. FUKUYAMA:  Oh, sure.

PROF. MEILAENDER:  — some issues that perhaps need to return regularly to public discussion rather than be bureaucratized?

DR. FUKUYAMA:  All organizations have bureaucratic cultures.  I mean, it's simply the — I think the nature of, you know, human behavior that there are informal rules that guide the way that, you know, people cooperate and make decisions.  And what you want to do is not to avoid having a bureaucratic culture, you want to have the right bureaucratic culture. 

And I think the problem comes up, you know, particularly when you talk about giving the FDA power to, you know, regulate things that have an ethical component, that has never been part of what they understood themselves to be doing. 

And I think the experience is that if you've gotten, you know, a group of regulators that really saw themselves as professionals, that kind of stood apart from these kinds of ethical considerations, it is really, really difficult to — you know, to get them to change.  And so what you would want to do presumably is create an institution where the bureaucratic culture supported ethical argument of the sort that we've had in this — you know, in this Council. And that would be part of the tradition of, you know, civil deliberation where you take seriously, you know, the kinds of concerns that, you know, fall outside of the mandate of the existing regulators.

PROF. MEILAENDER:  But a whole range of positions might not find their way into that deliberation, right?  I mean, there wouldn't be any reason to put some people on this regulatory agency if they simply thought that some of the things shouldn't be done that you were proposing to —

DR. FUKUYAMA:  Well, yes.  Again, you know, the composition of the agency would have to — I mean, our view is it should — is the goal should be that it should be as broadly representative of, you know, American — the American public's views of this as possible.  And as I said, that does not amount to the views of the existing well-organized interest groups, because we believe that those interest groups are way too polarized and are actually not representative.

We actually think that there's a group, you know, much larger group in the center that would be broadly supportive of this, and that's what we want to try to get at through these institutional mechanisms.  So I don't think it's that — you know, quite that whimsical.  I mean, we really are trying to make this, you know, both representative and deliberative.


PROF. GLENDON:  Alfonso's question I think reminds us of some conversations we had a while back about what other countries do.  I noticed that Frank refers to the Canadian and English systems, but deliberately bracketed the continental.

But if you recall, in a previous meeting, we saw that all of these matters are heavily, strictly regulated in the Romano-Germanic systems.  And so I think that — in my own experience, when I talk about these matters with Americans, they are surprised, as Alfonso was, that there is no regulation of that whole list of items that Frank just reeled off.

So I'm wondering, Frank, whether part of your project — I guess I'm hoping that part of your project, even in the deliberative stage, would be to try to use your deliberations to raise the public profile of the issue.  I mean, to this day, to this very day, we have people in the United States who think that Roe v. Wade only regulates the first trimester of the abortion — of pregnancy.

So this misunderstanding has been deliberately fostered by groups that have an interest in fostering that misunderstanding.  But it seems to me the same is true here, that as long as the — the actual state of affairs is not well-known, there are a lot of — of mice about playing.

So I wonder if you're thinking about, even at this stage, not just having closed meetings, or relatively closed meetings, but this is the kind of thing you could get on television with, you could — I mean, op-eds, I don't know how many people they reach, but I really think this is a hot subject. And that shock response that Alfonso had is a response that you would find in a more general public and that you would — there would be a way of educating the public to get better quality responses to the polls, and, in turn, get better ideas about the question that you and Jim were talking about.

There are many tools in the legislator's tool box.  And at this point, I think it's very difficult to say which is the right one, or what combination.  That's a very difficult technical question that is different for different areas.  But I think you might — if the public discussions should — could somehow be stimulated, you might get some guidance on the technical regulatory question.

DR. FUKUYAMA:  Yes, if I could just say  I think you're right, and one of the central purposes of our project was just to get this R word out into the public discussion, because, as I said, you know, I think actually if — John Evans wrote a very interesting book about the history of the bioethics — the whole bioethics profession.

But I think in some sense the reasons that you have bioethics advisory councils and commissions, and so forth, was a deliberate decision by the scientific research community and by the biomedical industry back in the 1970s to actually stave off formal regulation by, you know, in some sense inviting this self-regulatory model, together with, you know, essentially toothless advisory commissions.

And while I much enjoy sitting on this panel and hearing the discussions, I just think that that's not an adequate, you know — but there's been — but that strategy has been actually very effective, because any time someone has raised the question of regulation people say — you know, react as if they've seen, you know, the devil or Satan himself, and,you know, how can we talk about this?  Whereas, in fact, you're absolutely right that virtually every other developed country has, you know, addressed this much more seriously than we have. 

And so part of I think our purpose — and I'm glad that we have this opportunity to, you know, get this out, to simply put this in front of people and say, "Maybe you don't like our particular, you know, version of it, but I think we got — this is the real issue that I think we've got to address."  And not — and, you know, the more philosophical discussions I think are extremely important and rich.

But as a matter of public policy, I think this is where we've got to — you know, we've got to turn at this point.

CHAIRMAN KASS:  I am next, and then I have Mike, Peter, Paul.

One of the things that I like about the proposal, and in a way the idea behind the proposal, is precisely the beyond bioethics notion.  And the recognition that these questions are not questions that should be solved by some marriage between scientific/technical expertise presenting the shape of the problem, and so-called ethical expertise resolving it.

Anecdotally, there was a meeting at the National Academy of Sciences' Panel on Stem Cell Research, and I gave a presentation there in my own name.  And there was a dinner the night before, and one of the scientists there said, "Look," he said, "you fellows really could solve all of your problems on this Council."  I said, "Oh, really?"

He said, "Yes," he said, "you should just change the membership."  And I said, "Yes."  And he said, "Yes.  What you have to do is appoint ethicists, appoint bioethicists."  And what he really meant was the bioethicists that sit on the committee of the hospital where he is, where there really are no fundamental disagreements, and it took me half an hour to explain to him, look, the reason we have differences of opinion here is that there are real issues on which people are — are deeply divided and that are not somehow resolved by appealing to expertise.

And Gil, in a very nice little piece, responded to complaints against this Council that we had somehow politicized science or politicized bioethics, and he turned that accusation into a kind of praise, if by politicization it meant away from government by experts in these matters and a return of these questions to the polity as a whole.

So I applaud that, and I applaud whatever measures would be built into this to enlarge the public consultation, the public participation.  These are questions that really affect the well-being of all of us, though as we learned this morning one shouldn't exaggerate the ability of the public simply to understand or simply to decide with projections about the future.  I mean, there's — one should be very modest about this.

My difficulty comes with the question of what the conception of — not what the moral principles are, but what the view of moral judgment — the kind of moral judgment that such a body, since the final judgments will be left with these commissioners or with the commissioner as you will.

Sometimes, not in your account, but sometimes people say this really is a test for rule of the wise, not the experts mind you, but for people who are, you know, somehow the repository of the greatest wisdom that we can have about these matters.  And that should be the criteria for appointment.

There are people in this room who think that conditions of appointment should be governed by those capable of sound moral reasoning.  There are other people — in fact, the President when he met with us, I don't think I'm telling tales out of school — exhorted this body — we can debate whether we've been this or not — not to be sound moral reasoners, and not to be philosophers, but to be the nation's conscience in these matters.

None of those things do I hear from your proposal.  What I hear is something like a high-class National Opinion Research Center, which tries to take the temperature of the public and not function as the Burkean representatives of the public as we heard this morning, but, in fact, to find out where the public now is on these questions and take it there.

And maybe that's right, and maybe that's what it means turning these matters over to politics.  And it means perhaps finessing questions of inflexible moral principle and allowing this utilitarian country to, you know, find its most comfortable bottom.

But I guess I'd have to say that I'm slightly disquieted with such sort of large matters on the table to say that what you really want here is a group of people whose main virtue is they learn how to take the public temperature and blow with the wind.

Now, you haven't said that, but it seems to me what — what is there in the conception of this?  How does somehow taking — taking the opinion polls, or having these — you know, letting the guys who have access to the internet exercise their undue influence on this process, and actually trying to govern wisely in these matters, granting that we don't have philosopher-kings to rule, nor necessarily should we?

DR. FUKUYAMA:  Well, that's a very good question.  In a sense, that's why we had that two-tiered structure, because, you know, Jim's observations about the problems of commissions, you know, being well taken. You know, the idea was that you'd have a — actually, a smaller deliberative body that was composed not simply of the appointed stakeholders but, you know, of genuinely independent people that were capable of some degree of this kind of, you know, moral reasoning, and that would be selected for their ability to do that, that would actually have the real — that would have the real power to — you know, to make the decisions.

And all of these new — all of the new public participation mechanisms were not the point of that — you know, that smaller group was not simply to take the pulse of the public. But it was to take their input but use their own judgment — you know, combine that with their own judgment to — you know, to deliberate and to come to judgment.

So there really is a kind of two-tier — so there isn't a mechanical sense in which, you know, there are people with real statutory power simply trying to do this sophisticated polling. But it's something I think a little bit more balanced between — because I think that the other model where you simply delegate it to these wise men or women has also got a lot of problems, because, you know, they can get quite out of line with what is often the common sense, the common moral sense of, you know, the broader public.

CHAIRMAN KASS:  Good.  Jim, do you want to add something to this point?  Please.

PROF. WILSON:  Yes.  I don't really follow your point, Leon, because I may have underestimated the significance that Frank attached to these deliberative panels and the consultative college, and I hope I underestimated because I really think that's not the best part of his proposal.

I think the best part of his proposal is to go to Congress with whatever political argument will get him there.  As Mary Ann said, the average public person needs to be told that we are the only country in the world that doesn't regulate any of these things and get Congress to pass a law.

Now, Congress may well pass a law that says we're going to create this agency, and we're not going to allow research cloning.  But it will regulate all of these other things.  I don't know how the debate will come out, but that's one very likely outcome.  To me, that would be okay, because we would then begin to oversee other things.

Now, the other things that would be overseen would not be established by some government-sanctioned National Opinion Research Center.  These will be all things that Congress would decide.  Congress is very ginned up about this question.  They would start passing rules about chimera and hybrids and sex selection, and all of the other things that the ART clinics now think they self-regulate, but, in fact, don't.

So by the time the law was finished, and I would imagine it would be conservatively 50 single-spaced pages long, the Congress would have told the agency what to do.  And what the agency would wind up doing is administering those laws.

Now, I personally would hope they would allow research cloning, but I'm not optimistic.  But even if I'm wrong on that, it seems to me the debate will not be between Congress passing a general law that says, "Seek the public interest and implement it," and leaving to the agency the job of defining it.  Congress will define, as best as it could, all of these matters, and the agency I imagine will have relatively little discretion.

CHAIRMAN KASS:  Mike Gazzaniga, then Peter, then Paul.

DR. GAZZANIGA:  Yes.  So let's roll the clock back here a little bit and be concrete.  It was almost two years ago — two years ago that we had our little 10 to 7 vote, where 7 of us were against cloning of all types, 7 of us were for going ahead with biomedical cloning, with regulations, and we didn't specify what that meant.

And three — and two of them are here — Frank and Paul — were for — didn't have an ethical problem — but wanted a moratorium until regulations were in place.  Is this what you meant by "regulations in place"?  So the question I have is:  is this the kind of thing that Paul meant?  Is this the kind of thing you meant? 

And we can find out from Frank is — which all of a sudden means that we have 10 members who are for biomedical cloning, and not this, with the proper regulations in place.  Because I didn't, at the time, really understand what we meant by that, because I spend half my life trying to get around regulations.  So I —


I have an allergic reaction to the regulations.

CHAIRMAN KASS:  What did you do with the other half?

DR. FUKUYAMA:  Just on that one — you know, I didn't write a personal statement at the time that we took that vote, so I didn't explain my position.  But, you know, my position was that I was in favor of a moratorium, because I did not think it was safe to proceed with this until you had a regulatory structure in place, and I thought it would take at least four years to — you know, to produce that.

Now, that doesn't mean I'm in favor of doing it now, because this regulatory structure is just a proposal.  I mean, I think you really do need to make some progress in having in place an institution that will actually provide some real safeguards, not the Proposition 71 kinds of things, but some real safeguards.

And if we are into that process, and I'm convinced that, you know, that's reality, then in fact I will change my vote and, you know, vote with you.  But I'm not ready to do that now, because I don't think we're at that point.

PROF. GEORGE:  I think it's also true, isn't it, that Rebecca's argument was not an argument that had to do with putting a regulatory structure in place.  She's got a personal statement on it, and I don't think that the answer Frank just gave corresponds to what she said.

CHAIRMAN KASS:  Peter Lawler, and then Paul McHugh.  And we are getting close to break time, so if people want to add —

DR. LAWLER:  Yes.  I think I would be most for this in the way Jim Wilson just laid out.  As Congress would legislate extensively, and the point of the regulatory agency would be to administer the laws Congress had passed, because this is — it's an odd thing about America that on this issue the left is libertarian.  You would think that the left, as the body that — the climate of opinion that wants to regulate the excesses of capitalism, would want to regulate here big time because capitalism has so many excesses.

So in order for this to be possible, I think a bill that narrowly passed Congress because of a Republican majority and Democrats from red states voting for it out of necessity, wouldn't give us what we need.  The left has to be converted in some respects.  Mainstream Democrats have to be converted in some respects to the idea that regulation in this area is appropriate. 

And it's strange that our country has been transformed, that on these crucial cultural, social, life issues, the Democratic Party is the libertarian party now, because to listen to the Democratic Party you get this opinion:  You have sensible people, and you have religious nuts.  And the sensible people are for no regulation at all, even though — so the sensible people are not to be told what goes on in Europe, and even in Canada and Britain, and so forth.

So the first step here is for someone — Frank and his friends — to — to enhance public awareness of this.  This, more than other areas of capitalism, demands regulation because of the great possibilities for the destruction of life and for tyranny in this area.

CHAIRMAN KASS:  Do you want to hold off, Frank, and we'll get Paul McHugh's comment, and I think that's where we are.  So we'll —

DR. McHUGH:  Yes, I have a comment and a question.  First, the comment is that, yes, Mike, this is what I was looking for.  I'm looking for the building up of a regulatory system — a regulatory system that is responsive to the American people through the Congress, and should lay out right off the bat what we're doing and start putting some sense into this free market system that has all kinds of abuses to it.

And you know that, though, as well I believe there is a difference between in vitro fertilization and the use of those embryos and somatic cell nuclear transfer and those things.  I won't, once again, raise the clonote, but it lives.

Now, I have one question, and that is:  why do you start off by saying that embryos have — the whole idea about this is intermediate status for the embryo?  You just get people's dukes up.  Why don't we just get started and saying on the regulatory business, "We need a regulatory agency.  We have Jim's genius and your genius to start putting these things together and make it happen."  What do you want to get people's dukes up for?  So that's question one.

And then, it's just a question of fact, and that is this issue of polling, and views that the American people have, which have been so often wrong.  On page 10 of your things, you confused me when you said that the interest groups demonstrate that the public attitudes towards research cloning are that fundamentally people oppose it two to one.  And then you come down here and say what human embryonic stem cells, though, are — polls show that they are for embryonic stem cells.

But the question is being asked there of them, from which you have developed that idea, is "should excess embryos be used in medical research?"  And the operative word there is "excess."  And if in the process of asking that question you — you told people, "by the way, we're going to produce these excess embryos every time we have an in vitro fertilization experiment, because we're going to make 8, 10, 12 of them, and they're going to be around, and we're going to continue to make these people— do you really want to make these embryos? " What would the American public say?  I believe the American public would say, as the German people say, no IVF unless you're going to implant them.  And why not?

DR. FURGER:  If I may, I mean, it's in part a matter of how these questions have been phrased.  But generally speaking, the surveys have tended to distinguish between a possible use for research purposes of excess donated embryos as a self-contained question on the one hand, and the possibilities of — the possibility of conducting research cloning as a separate issue.

Now, obviously you can combine these two things.  But if you ask this question in a separate manner, you realize that when cloning is implied, there is much more ambivalence about the procedure, whereas a semi-pragmatic approach, the use of excess embryos for research purposes, you know, it's a lot less —

DR. FUKUYAMA:  Existing ones that are already in — you know, being stored, cryogenically stored.

DR. McHUGH:  I mean, that's something that we ought to be talking about broadly in the public. And building up a regulatory agency and hearing from the Congress as to whether they think the excesses are going to continue to become excess — because whether we're going to continue the process of in vitro fertilization or not becomes a matter for regulation.

But, anyway, I just think the way you ask that question to anybody in the — in the population, you ask them — "Well, they're going to die anyway, so there you — let's do something with them."  Everybody gets up and says yes. 

But if you say tomorrow, "Well, look, we're going to start producing these so-called excess embryos because, after all, they're accessible to us, and we ought to build them.  And when we do them, we're going to implant some, and we're going to chop the others."  Then, I think the American people will probably rise up, like they say about research cloning here and say, "Not on your life."

But that's to bring us back to what Alfonso — what you said you didn't want to develop here.  Answer me this question:  why do you want to start this off by saying something which raises a red flag about the intermediate status of the embryo?  Just tell me that.

DR. FUKUYAMA:  Well, that's — it's very simple, because I don't think you can sneak it by people.

DR. McHUGH:  Oh, I see.


DR. FUKUYAMA:  I mean, this is a proposal to create a regulatory agency that would legitimate stem cell research.  There is just no — and it will involve embryo destruction.  The most limited form of that is — is using, you know, preserved embryos in existing, you know, embryos in IVF clinics. 

But if you believe that that is illegitimate, period, then you're not going to like this proposal.  And I just didn't think that it would — you know, I mean, so I just thought it's better to be up front about the fact that —

PROF. WILSON:  Well, Frank, there's another strategy.  The other strategy is to make the list of all of the things that ARTs don't like and don't approve of, but are done anyway, and make those the subject of federal legislation. 

I mean, the only way you're going to get Congress to pay any attention to this bill is to call attention to widely-admitted abuses, regulate them, and then cross the next step, if you can cross it, which is to say, well, we've got a regulatory agency, it's working reasonably well, shouldn't we be allowed now to use excess embryos from IVFs?  You don't want to start with the IVFs.  That is a political loser.   Start with the abuses.

I mean, I don't know why we're sitting around having a talk about practical politics in Washington, D.C.  It seems so inappropriate.


I'll shut up.

CHAIRMAN KASS:  That's why we bring people from California who know something about it.

Let me make one — just one — I lost it.  It wasn't that important.

Let me just thank Franco and Frank for bringing this — this proposal back before us for discussion.  We'll adjourn until tomorrow morning.

Those of us meeting for dinner, Primi Piatti is at 2013 I Street, one street to the north and about five streets to the west.  And you're better off walking on I Street than on H, where there's construction.  Tomorrow morning we start at 8:30.

Oh, I remember what it was.  On this business about the stem cells, tomorrow morning we're actually going to hear some interesting things on this subject, which might provide a way forward that doesn't require one to lead with one's chin, and nevertheless provide some suggestions that if all goes well might command some interesting assent around here.

So let's look forward to that presentation tomorrow, as well as the presentation from our Canadian colleagues.  Let's be on time for them at 8:30 tomorrow.

The meeting is adjourned.

         (Whereupon, at 5:32 p.m., the proceedings in the forgoing matter were adjourned, to reconvene at 8:30 a.m., the following day.)

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