Meeting Transcript
July 24, 2003

The Ritz-Carlton
1150 22nd Street, NW
Washington, D.C. 20037
202-835-0500

COUNCIL MEMBERS PRESENT

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

Elizabeth Blackburn, Ph.D.
University of California, San Francisco

Rebecca S. Dresser, J.D.
Washington University School of Law

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

Francis Fukuyama, Ph.D.
Johns Hopkins University

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

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

William F. May, Ph.D.
Southern Methodist University

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

Gilbert C. Meilaender, Ph.D.
Valparaiso University

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

Michael J. Sandel, D.Phil.
Harvard University

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

INDEX

• Welcome and Opening Remarks
  
  
• Session 1: The “Research Imperative”: Is Research a Moral Obligation?
  
  
• Session 2: Stem Cell Research: Current Ethical Literature
  
  
• Session 3: Stem Cell Research: Recent Scientific and Clinical Developments
  
• Session 4: Stem Cell Research: Current Law and Policy with Emphasis on the States

WELCOME AND OPENING REMARKS

CHAIRMAN KASS:  Could I ask Council Members to take their seats so that we can get started?

Good morning.  Welcome Members of the Council to this, our twelfth meeting.  Welcome also to members of the public.  I'd like to recognize the presence of Dean Clancy, our Executive Director, the Designated Federal Officer, in whose presence we have a legal and proper meeting.

And I would also like to take this opportunity on behalf of the Council to express our congratulations to Jim Wilson who yesterday received the Presidential Medal of Freedom.  Congratulations to you, Jim.

(Applause.)

A word of thanks to Council Members for your loyalty and devoted service and especially this time for the heroic amount of material that you have, I would assume, read or will have read before long.  I warn you there is more to come, but we are in your debt for your attention and comments, of course.  Welcome.

The first session of this meeting, "The Research Imperative:  Is Research a Moral Obligation?" does double duty in this Council.  First, it's part of our ongoing effort at what we call a richer bioethics and second, it does have something to contribute to the on-going discussions of the ethics of stem cell research.  It will continue our effort to lift up to view some of the unstated assumptions that lie behind the debates, say about stem cell research or cloning for biomedical research, assumptions that rarely get the attention and scrutiny that they deserve.  We've paid some attention to the assumptions about the moral status of the human embryo. 

At the next meeting we want to look at the ethical and political meaning of funding or not funding ethically controversial research in a pluralistic society.  And today, we're going to look at the so-called imperative of research, especially research in biomedical science that could lead to cures for diseases.

No one doubts the great value of such research and no one should have anything but admiration and gratitude to the generations of scientists who have pushed back the frontier against ignorance and who provide knowledge and techniques fruitfully used to alleviate human suffering. 

The question is, rather, what kind of a good is such research and what kind of an obligation do we have to pursue it?

Is it an unqualified obligation, a so-called perfect duty that takes precedence over possible objections and concerns, especially ethical ones?  Such seem to be, at least the implicit view of at least one scientist who presented to this Council, who in so many words indicated that this Council would be held morally responsible for any lives that were lost should we erect any legal barriers to cloning for biomedical research and similar opinions have been voiced many times in the public debate in recent years.

Others have argued that there is no moral or social obligation to medical research at all, even if such research were a social good and good for us, but rather an optional goal to be pursued, one among many and by no means supreme.

To help us continue to think about this question, is there an imperative to research and if so, of what sort?  We're very fortunate to have with us Daniel Callahan, the co-founder and for 27 years the Director and President of the first bioethics think tank of the United States, The Hastings Center.  Dan Callahan has a nose for all the tough big questions in the field, as the titles in his résumé will show.  And moreover, the courage to try to make other people face up to them.

It is the tough question of the research imperative that is the topic of his forthcoming book, What Price Better Health:  Hazards of the Research Imperative and that makes him the perfect person to get us thinking about this today.

If I might add a note of personal pleasure, I was a young researcher at NIH almost 35 years ago when Dan Callahan was starting The Hastings Center and he invited me to the first organizing meeting of what would become that center and in an ill-fated writing venture Dan and I were co-editors of a volume called Freedom, Coercion and the Life Sciences for which I had written a chapter on "Freedom, Coercion and Asexual Reproduction" whose arguments I've been cloning ever since.

Dan, it's a great pleasure to have you here.  We look forward to your presentation and discussion.

SESSION 1: "THE RESEARCH IMPERATIVE": IS RESEARCH A MORAL OBLIGATION?

DR. CALLAHAN:  Leon and I have worked together for a long time and I can remember my first discussion with you, I think, at my house on Summit Drive, and we talked and you seemed exactly the sort of person I was looking for.  You were suggested to me by Paul Ramsey who many of you knew.

It's a double pleasure being here then to be with Leon and this particular Council and also because I think I know at least two thirds of the people on the Council and it's so nice to see you collected here.

The term research imperative first arose for me with an article that was in The Hastings Center Report and Paul Ramsey used the phrase.  He engaged in really a most interesting debate with the Jesuit theologian Richard McCormick on the question of human subject research on children, particularly what's called nontherapeutic research, for the sake of knowledge, rather than direct therapeutic treatment of children.

And McCormick argued that children should be available for nontherapeutic research.  Their parents should be willing to make them available as a sort of a noble sacrifice for the good of humanity and the advancement of research.  Paul Ramsey rejected that notion altogether, felt children should not be used in that way and accused McCormick of falling prey to the research imperative.

I had no particular interest in research at that time and it had passed out of my head, but shortly thereafter I did run across Joshua Lederberg, Nobel Laureate, former President of the Rockefeller University who said to me at a meeting, I gather something similar to what Leon quoted at another meeting saying "If we don't carry out research, the blood of those who die will be on our hands."

I wondered at the time whether that was true, but again had no particular interest in research and didn't pay much attention to it, so it faded away.  But in recent years, all of that sort of came back to me for a variety of reasons.  I got interested in the whole enterprise of biomedical research in this country, particularly in this country, although obviously it goes on in other countries as well.

And there were a number of things that caught my eye.  First of all, the NIH budget is something of a federal marvel.  So far as I know it is the only budget that hasevery year without fail gone up rather than down.  A researcher went through all the transcripts of hearings of the National Institutes of Health and it has always had complete bipartisan support.  There's never been any serious dissent of any kind. 

There has been some discussion in recent years about the priorities of NIH, but basically no objection to an increased budget and typically the President each year, whether Democrat or Republican, has put in for a certain amount for the budget.  Congress has always found that inadequate and forced the NIH to take more money and they were happy enough, of course, to take it.  So the NIH budget caught my eye as an interesting phenomenon in American life.

I got interested also in the escalation of what I think is escalating history of medical research in this country where research was a worthy cause in the late 19th century when it first was taken seriously in this country, particularly in medical schools.  But the kind of shift from a worthy cause to a kind of imperative, necessary cause which really came into play after the Second World War and I suppose nicely symbolized by President Nixon's declaration in 1970 of a "War Against Cancer."  And thereafter, language of the imperative of research became stronger and stronger.

More recently the stem cell debate caught my eye since many people have argued and you may hear it in your discussion, but a moral duty to pursue such research.  Simultaneously, more or less, the pharmaceutical industry, for those of you who follow it you can't help following it a bit these days, pharmaceutical industry has long claimed that they, the main reason they need the high profits is in order to carry out research which is going to save future lives and relieve future suffering.  Hence, they have used a very strong research imperative argument in justifying their drug pricing and the like.

Now to me, the interesting question is, why has this happened?  What has been the reason for this kind of increased interest?  It's rather striking, if perhaps unusual, that health care, I suppose - particularly NIH research, but it is a budget that has gone up despite the fact that health is getting better.  It seems to me there's some straight line correlation between the better health we have, the more money we spend on health care and particularly the more we think we ought to spend on research and the argument there is, of course, the prospects of new breakthroughs are greater than they've ever been historically and therefore we should go after them.

In any case, as health gets better, the budget goes up and spending on health care continues to go up as well.

Now I think that there are a number of things culturally that have happened.  First of all, I think there's a very strong feeling in this country that illness and disease, which have always been considered human evils have taken a kind of transcendent status as evils in our country.  They are seen as among the worse things that can happen to people, one of the most important things we can spend money on, and that there is really nothing better we can do for each other than to invest money in research to promote better health.

I think also, as part of that, is that one shift that I think has taken place since the Second World War has been a kind of abolition of fatalism.  It's been argued that in the past we reconciled ourselves to aging and death simply because we could nothing.  People could do nothing about it and then it had to be rationalized, it had to be given a place in human life, but fatalism, many would, in effect, argue should be put behind us.  Now we can do something about the evils of illness and disease.

The political scientist, Michael Walzer, I think very perceptively made this point about 20 years ago when he said, "What has happened in the modern world is simply that disease itself, even when it is endemic rather than epidemic, has come to be seen as a plague.  And since the plague can be dealt with, it must be dealt with.  People will not endure what they no longer believe they have to endure."  That was from his book, Spheres of Justice.

I think it's also the case that the pursuit of health through research is seen as not only a good in itself, morally and socially, but also of great economic benefit, both in the lives saved and the future productivity of those lives, but also in the jobs and profit that research generates.  A strong argument behind the annual NIH budget is that the research is exportable.  It's one of America's great products.  People need it.  They love it.  And they will spend money for it.

Most importantly, I think, and an issue that's worth a side discussion, but we won't have time to get into today, a strong argument that medical research offers the greatest promise of eventually reducing our escalating health care costs.  A number of economists, David Cutler and the new Commissioner of the Food and Drug Administration, Mark McClellan, have argued very strongly that research and biomedical investment is the greatest investment that has been made on anything in this country, that has been worth trillions of dollars to our economy.  And both the pharmaceutical industry and from time to time the NIH itself has argued that better research is what will beat the problem of rising health care costs.  I would add as a footnote, it hasn't happened yet.  It seems to me a wonderful idea, but the historical record is not encouraging.  Anyway, the argument has been made.

Now I want to really make three basic contentions in this talk.  I'm going to make them and let's see if I can defend them and make them quasi-persuasive.

First of all, I want to argue that, in general, there is no moral research, no moral imperative or duty to pursue medical research, or in particular, to pursue any specific line of research.  Research, I want to argue, is a moral good to be weighed against other human goods, but not an overriding moral obligation.  That's the first contention.

The second is that in the absence of what I will call a common metric, there is no rationally justifiable or viable way of balancing the moral good of research against other claimed moral goods.

And my third contention is that in the legal and ethical policy, international policy now in human subject research that has developed since the Nuremburg Trials in 1947, the principle of informed consent for competent patients has come decisively to overcome any and all claims of research benefits that could come from violating the principle of informed consent.  I think this has great historical significance.

Let me go to my first contention, why is there, with one exception I will shortly mention, no moral obligation or duty to carry out biomedical research, but at the same time one can say that research is clearly a moral good?  I offer you three considerations for that.

First of all, this is a point that philosophers sometimes make about the very notion of obligation.  Philosophers distinguish between  perfect and imperfect obligations.  A perfect obligation is one which is based on a specific promise we have made.  We're then obliged to keep it.  Or an obligation that flows from certain types of roles we take on such as doctor, policeman, lawyer, what have you, obligations that typically are called role obligations and they go with the carrying out of particular professions.

So an imperfect obligation by contrast is one where no one in particular has any obligation to carry it out.  We talk about it as an obligation, but one cannot say that any given individual has a duty to carry out the obligation.  In that sense, it's a very weak kind of obligation.  Indeed, it's not clear when you talk about imperfect obligation whether you ought to use it at all, talk about obligation at all, but nonetheless that has typically been done.

And here I would want to argue that medical research falls in the category of an imperfect obligation, imperfect in the sense that it's not clear whose duty it is in particular to carry out such research.  One can't even claim that of the researcher.  If a researcher decides to do basic research with no interest in therapy, one would hardly accuse that researcher of being irresponsible or to say that any given researcher had a particular obligation to pursue this or that line of research.

So in that sense, medical research itself would be a classic case of an imperfect obligation.  Now it might well be the case that someone in say the field of genetics who took on particular issues pertinent to society or therapy would have some moral obligation to carry through on that if the person had chosen to do that research it would then begin to take on some of the characteristics of a perfect obligation.  But there's no obligation in the first place that a person become a particular kind of researcher.

Now this may seem like a rather technical, indeed, precious point, the kind of thing philosophers have lots of fun with, but don't persuade many others.  I think the question is pertinent because if we're going to talk about a duty to carry out research, and obligation of research, we really then have to ask, in what sense are we supposed to carry out research and what moral sense is there a claim upon us?

I simply want to argue that it is perfectly possible to talk about it as a good.  It's an ideal of our culture, a very strong ideal.  It is based on the notion of a duty of empathy, mercy, of the relief of suffering, the virtue of beneficence, the virtues of mercy.  And in that sense, one can make a very strong case that it is a good thing to do, but not necessarily a strict obligation.

Now by calling it a good thing to do, it seems to me one then has to raise the question well, how does it compare with other good things we might do?  As an economist might say, what are some of the optional ways we might spend a similar amount of money?  How do you compare the value and need for man's educational needs, national defense, jobs, all sorts of other things that societies need in order to function well?

It seems to me then once one has said it is a good, and simply a good and not necessarily the highest good, then one is in a situation of trying to juggle budgets, juggle moral priorities and make a determination of where we want to locate health over against other things we might do with our money and with our aspirations.

I think it is fairly obvious in this country, as at least symbolized by the NIH, that we have given it an uncommonly high status and this is clearly not the case in other countries.  The British, the French, the Germans all spend money on medical research, but they don't put nearly the amount of money into it as we do in this country.

But I would point out that we don't consider it morally objectionable that they spend less money on research and more money say on other things, since it seems to me once one begins talking about comparative goods for society, this will be determined by the politics, the values, the history, culture and a lot of other things.

So basically, I have a very modest kind of goal here, which is simply to use an old fashioned term from theology, demythologize the notion of a research imperative by simply saying sure, it's an absolutely good thing to do, but once we've said it's a good thing to do, then it has to be compared with and compete with other goods in society, whereas to talk about it as a duty seems to act for many as a kind of a trump care which then allows people to not only ask for more money than they might for other things, but also to argue that somehow we have an inescapable duty and I want to argue with that.

Now I would make one exception which I think is important in our world.  I think one can make a very strong case that there is something pretty close to a duty when you're talking about infectious diseases and particularly disease such as AIDS; diseases that don't simply kill people, but mainly kill younger people and in particular kill those who are responsible for the running of the society.  And one of the great problems in sub-Saharan Africa is not simply a high death rate although that, of course, is horrible, but the point is that what we're seeing is the destruction of the health care workers, the police force, government administrators, all the people that make society run, and of course, leaving thousands of children as orphans.  So it's very destructive on the family.

So it seems to me that plagues and particularly those that affect younger generations and affect the infrastructure of society and not simply the death rate stand out as a particular exception, which is only to say in a way that there is a difference between what was called the endemic diseases, cancer, heart disease and the like and contagious diseases that seem to fall into a different category.

Now let me respond to the Lederberg argument.  I think when we think about the Lederberg argument, the idea that somehow it's a sin of omission not to support research and therefore we will bear responsibility for the results of failing to support the research, this will certainly be true if we consider a very hard and specific obligation a duty, therefore, we will have seen, failed in our duty and thus to be condemned.  But it seems to me one has to really ask about all the other needs of society and ask is it really wrong to decide in a given society, at a given time that education, say, is more important than health care. 

In this country, we have more or less spent around 6 percent of our gross domestic product on health care for nearly 30 years or so.  We now spend about 14 percent on health care and around 3 and 4 percent on defense.  Thirty-five years ago we spent about 6 percent on each.  So one can really raise the question whether it makes a great deal of sense or there leads to a balanced society to allow one sphere, namely health care to so remarkably outpace all of the others, as if somehow our education system is terrific, we needn't put more money in that, but only health care deserves the constant escalating budget that it typically gets.

Now I think in trying to ask the question of research as a good and comparing it with other goods, we really are forced to ask what kind of an evil disease, suffering, and death are.  Clearly, they are very important evils.  All societies have considered them evils.  As I suggested maybe earlier fatalistic societies had to develop rationalizations and ways of making sense of them.  Many of these, I believe, still make sense, but we have at least entered a period where there is not much pleasure taken in arguments that seem to have a fatalistic flavor to them. 

So that pushes us really back to the question of let's take, for instance, the question of death.  I think it's very pertinent to ask what kinds of death are comparably more or less evil.  There's death by disease.  There's death by social violence, war, domestic violence and the like.  There's death by accidents.  There is death by poverty.  Can we rank in some sense, even if very crudely and roughly, can we rank those deaths in terms of evils?  I myself would say that the greatest, the worst kinds of deaths are those that come from social violence and deaths that are unexpected, unnecessary and are a function of human evil, rather than biological evil.

We can obviously argue about that matter, but it seems to me it's important when we begin thinking about the comparative good that medical research can bring, what are the comparative evils we are trying to overcome and how do we want to understand and rank those evils?

To my mind, premature death is something to be worked against.  Threats to public health are to be worked against.  This would particularly include infectious diseases and threats to sanitation, air and the like, and I suppose anything that threatens the ability, particularly of people in their adult years, to run families and to manage societies.

I would want myself to classify the endemic diseases of modern society, particularly those that primarily affect older populations, as comparatively low priority.  That is to say they are terribly important.  People - it would be a good thing to cure cancer, heart disease and the like, but it seems to me in terms of social priority, I would want to argue that they have a comparatively low priority and it's very difficult, I believe, to say that we have an obligation to overcome cancer and heart disease as much as they cause individuals suffering.  I use that as an example because my family has a history of cancer as a cause of death and certainly that brought suffering to our family as to many other families, but I think if one takes a social perspective on, say, death from cancer, one would have to say that while a source of great pain and suffering for individuals, it is not a disease that threatens the very structure of society or the overall functioning of society.

I might mention a very interesting quote by Harold Varmus.  Harold Varmus, many people will recall, was the Director of the National Institutes of Health, a Nobel Laureate and I think considered a particularly effective Director.  He retired - he left that position in the year 2000 and is now president of Memorial Sloan-Kettering in New York.  In his last talk he gave to the staff at NIH, he said something very interesting that was not picked up by the press, but I thought was very radical for a Director of NIH.  He said first of all, he said I think we pay too much attention to health in our society, an interesting thing for an NIH Director to say; and the second thing he said was he was concerned that too much of the research they were carrying out was going to produce products that Americans would not be able to afford to buy.

And it seemed to me that was what I thought was the very first time that anyone in a position like that began to question some of the very basic work that the NIH has been doing.

Now let me bring in a third consideration here.  It seems to me that if one cannot say that health is an overriding good as I would want to say, but it is one of many goods, then the question is really how do we balance the ensemble of human goods necessary to make up a society?  Obviously, a society where you have a very low death rate from the endemic diseases, but is one marked by social violence, corruption and other things will be a lousy society to live in, however healthy physically people may be.  And for that society a priority would want to be given to dealing with the social problems of the society.

The question always would be, if one wants to say health is a basic necessity for human beings, obviously the same thing can be said for food, clothing and shelter and maybe a slightly less sense of the importance of jobs and other things for society.  So the question then is to find a way to decide what priority to give to health compared to the other goods and at the same time to recognize that the aim of a society is to find a way to get a good balance between all the needs and not just one.

I am particularly interested in this issue because while the research drive has received an awful lot of money and great attention, we have done less well with the delivery of health care in this country.  We've spent a lot of money on research, but we have spent less money doing research on how to better deliver health care and there has been far less public debate, much less agreement on the value of say achieving universal health care in this country.

Harold Varmus said something rather radical for somebody in his position.  Floyd Bloom, who is the recently retired President of the American Association for the Advancement of Science and before that editor of the journal Science, said very interestingly he thought we should spend less money on medical research and more money on the delivery of health care, because we have a paradoxical problem in this country.  Namely, we have a research agenda that's going forward to find cures for disease, but there is by no means any guarantee that all Americans will be able to receive the results of those disease.  There are some 41 million uninsured in this country.  There are many people who can't afford the drugs that are coming out of the research enterprise, the pharmaceutical industry and yet somehow we can't seem to find unanimity to deal with that problem the way we can in putting money into research itself.

Okay, so much for my thoughts on the obligation to do research.  Let me turn to the issue of balancing research against other goods and values.  Here I mean to talk very generally about balancing research against other human needs and goods, but here I want to particularly look at the language of balancing when, in the moral debate, because it is often said and has been said in many government reports that we must balance various considerations.

Let me give you some obvious examples.  In the human subject debate, the question has been one of balancing potential, harm to subjects against potential research benefits.  I'll come back to that issue.  In the stem cell debate, a very common use of balancing language there; namely, the destruction of balancing the destruction of early embryos against the potential benefits of stem cell research.  A third area that has received some attention lately, the protection of privacy against the public health benefits that would come from epidemiological  and collecting information on people's health behavior and other items concerning their health. 

In short, in each of those debates, the issue has arisen, how do we balance the potential harms of doing the research and what harms of different kinds over against the potential values.  Now I find this very interesting, first of all because it seems to me one can't really use the language of balance in any meaningful way unless one has a kind of common metric, that is to say, it's the old question of sort of comparing apples and oranges.  In that case, the issue you can talk about is the fruit, but in many of these other cases, the differences are very great between the values to be pursued.

Now it seems to me that unless you have a common metric, you really can't do that in any meaningful way.  For instance, by a common metric, I mean if your physician says look, you have a very painful condition, we have some surgery that will relieve the condition, but the surgery is very painful, then, of course, you have a common metric of pain and you can do some serious balancing.  But in the cases I've mentioned, the human subject research stem cell debate, protection of privacy, we don't have anything that works in such a tidy manner.

Now my own observation is that, lacking this common metric, and despite the language of balancing, the de facto results of efforts to do so have pretty much reflected the ideological, prior ideological commitments of the people doing the balancing.  I look at the language of balancing in previous national commissions beginning with the National Commission for the Protection of Human Subjects in the mid-1970s through three other federal commissions and finally this President's Council, I'll leave out this one, but the other ones use the language of balancing, but pretty much the balancing would typically go in the direction of the known policies, attitudes, ideologies of the Commission Members. 

And it seems to me there's probably no other way of doing it.  People will bring to bear on balancing questions their previous commitments.  Hopefully, they may have been influenced by arguments and debate they heard, but nonetheless, they are likely to act out some of their deepest values and that will tip the balancing one way or the other. 

And of course, one way you achieve balancing, there are a variety of ways.  One is simply decide that on the balancing of a see-saw, one value really isn't such a high value after all and you get rid of it entirely and thus getting rid of the problem or you find some way to make one of less value than the other, but in point, all I want to argue is I don't think there's any very rational way of doing this.  It ends up a matter of politics, maybe in a good sense, but still politics rather than any form of rational calculus.

The third issue I'd like to look at is that of human subject research.  I think the history of human subject research offers a very interesting perspective on the question of balancing and also on the research imperative.  Although the famous physician William Osler, at Johns Hopkins over a century ago insisted on the importance of gaining informed consent from human subjects, and even a German Commission, interestingly, in the early 1930s made it a moral requirement, it was only slowly and fitfully accepted by medical researchers.  Their objection over the decades, as one might guess, was that research requires human subjects, that medical progress cannot take progress without the use of medical subjects and that the cure of disease took priority over any claimed rights of subjects to be free of having their bodies invaded by researchers.

In short, there was an effort - an effort was made to look at the problem of balancing, but by and large, in earlier decades, probably the Second World War, the balance was always typically in favor of the researcher and again, the arguments are rather familiar ones.  You can't do the research unless we go forward without the consent and in any case the saving of lives and the relief of suffering is something that is of higher value than the protection of human subjects.

A friend of ours, Leon remembers him well, Robert Morrison, a physician, said of his medical training in the 1930s, it was hard to take the idea of informed consent seriously when so many of our patients were dying all around us, particularly young people.

Well, all of that changed with the Nuremburg Trials in 1947, trials of the Nazi doctors accused and correctly indicted for many horrible medical crimes, particularly crimes involving human subject research.  Out of that trial came the Nuremburg Code which at its very core had the idea of informed consent as a necessity.

Nonetheless, despite the blessing of the Nuremburg Code, it took many years for the report really just to sink in and again the arguments against it were the necessity of the research, the value of the research, and one that became increasingly common, the fact that your average lay person would simply be too incompetent, too ignorant to make informed judgments.

In any case, over a period of time, by virtue of the Nuremburg Code, and by other codes that were developed, the principle of informed consent was accepted and accepted in the face of many rationalizations to evade it.  And it's very interesting because I think the rule at present, in effect, says competent subjects have a right to make, give informed consent and without their informed consent, no research may go forward, regardless of how many lives might be saved, how much suffering might be relieved.  It is a hard and fast rule.  We basically get rid of the problem of balancing all together and said this is not an area where balancing is appropriate, patients must be protected.

Now this was, I think, a very important precedent.  It said something about the research imperative.  It said something about the competence of people, even lay people, to make informed judgments and it certainly said something about the necessity to bring in regulation of something very important.  A number of people who believed in informed consent such as Henry Veatch, one of the people who blew the whistle in the mid-1960s on the problem, said it would be certainly important that there be a moral requirement for informed consent, but the government ought not to enter in and try to regulate this area.  It should be left to the integrity of the researcher.  Well, that view was rejected.  The institutional review boards were born in the late 1960s and it is now a firm regulatory requirement that research be protected by informed consent.

Now I might mention that, of course, as many of you are familiar with earlier Commissions, the issue never gets totally solved.  Efforts to this day still go on to evade informed consent.  The work of institutional reviews is endlessly being reviewed, criticized.  Nonetheless, I think it very striking that this one principle did endure a lot of criticism and particularly criticism from those who argued for a research imperative to do the research.

Let me end - I'm not charged to say anything about the stem cell debate, but let me try to make a few applications of what I've said generally to that debate.  First of all, if there's anything to what I've said, it is not appropriate to talk about a duty to carry out stem cell research, even if you believe it extraordinarily valuable, even if you believe there aren't any terrible moral objections against it.  It seems to me inappropriate to talk about it as a duty.  It certainly doesn't meet the standards I've suggested.

Now even if we want to say, however, it is not a duty, but simply a high good, then the question is high how a good and how are we to think within that context.  The thing that has certainly caught my eye is that it is claimed to be promising research.  But I'm struck by the fact that the National Institutes of Health over the past few decades has spent literally hundreds of millions of dollars on other promising research for the very same diseases that stem cell research is supposed to help.

In the case of Parkinson's disease, an article a couple of years ago listed 10 different research lines being pursued for the cure of or relief of Parkinson's disease and certainly that's the case with heart disease, spinal cord injuries and lots of other things as well.

Therefore, one can hardly argue that stem cell research is the only possible way of - unless someone once said the NIH has been wasting lots of money on everything else over the years, I don't think they would want to say that.  One would have to say the stem cell research is promising, but other things are promising as well and that this might be even comparatively more promising, but promising in and of itself is not enough to constitute a duty to carry it out, particularly when there are alternative lines of research.

I would notice something else that people haven't noticed which I found at least amusing.  Christopher Reeve who has been a great proponent of stem cell research, as you know, there's been a couple of stories about him over the past year, one that he is now able to have some movement in his limbs that he didn't have earlier and this came from recent research on rehabilitation.  And secondly, that he is gradually being weaned from a ventilator and this was cited as a sign of research progress on weaning people from ventilators.  In short, some of these other alternative lines of research are working on his very condition and bearing some fruit.

I think on the question of balancing and here, this is where the balancing issue has come in very strongly, how do you balance the claims of an embryo against the potential of benefits from the research itself?  Well, I guess the question is one thing is pretty clear, embryos are killed in order to carry out the research for research that is promising,   its hypothetical benefits over against at least some real harm.  Now unless one believes that embryos have no moral standing whatever, which some do, of course, one is then left with - or believes that they have such moral standing that they shouldn't be used at all, but if you're like many of us in sort of muddling around in the middle there, then the question is how do you balance off the decisive harm done to embryos against hypothetical benefits?

It seems to me that at least from the way I think about the issue, there is one kind of common metric here, that is to say we're talking about the potential value of the life of the embryo over against the lives of future victims of disease.  But it seems to me the question is again, it's not a very good metric because it's still a hypothetical benefit.  We don't know the stem cell research will, in fact, work.  We do know that lots of harm can do lots of harm to embryos to get there.  So I suppose I would want to try to think about the matter in terms of how likely are the benefits and even if we don't believe that there's full human life present in embryos, what do we mean when we say, as many former Commissions have, that embryos deserve respect.  I think that is a kind of way on the part of the embryos a certain insecurity about the way we talk about embryos, even among those who don't believe embryos should be considered a full human life worthy of full protection.  I think the language of respect has been invoked as a kind of middle level term, if you will, to help us say well, we don't think they're nothing, but at the same time we don't think they have quite enough standing to merit their non-use for the sake of research.

I suppose I would want to end by saying on this issue and here I will simply end by saying this, I think embryos have a fairly weak moral claim, but on the other hand I think the research claim is even weaker.  Thank you.

CHAIRMAN KASS:  Thank you very much, Dan.

Let me just simply throw the floor open for comment.  Elizabeth, is that half a hand, Elizabeth Blackburn?

PROF.BLACKBURN:  I would like to address the points that you raised in the last part of your presentation.  With respect to stem cell research, you point out that the NIH has, of course, spent very much more money on different kinds of research avenues from stem cell research.  But I think we should acknowledge that the reason for that has been partly because there has not been the possibility to do very much stem cell research because of the situation being so limited right now.

So it's not that the stem cell research has been abandoned.  It's being sufficiently useful compared with other avenues to pursue it.  It's simply that we at this stage haven't had the opportunity, we as a society, to look into it.

I think it's early days.  And you pointed out that there hasn't been a whole lot of evidence about how useful it can or could not be, but again, the only way to find out that is to gain the knowledge.

So I think I was getting from you words somewhat of a sense that you were thinking that extensive research was the inferior mode of research.  And I was just going to point out that we really don't know that at this point because we have not had the opportunity.

Another quick point I wanted to raise about Christopher Reeve.  I think that the news is wonderful that the injuries that he had were in some way not completely irreversible, but I think that what he acknowledges is that he was in a rather unusual position of having a lot of resources.  And he could devote enormous resources, financial, into having the very, very intensive sorts of effort put into his rehabilitation, which I think is not commonly the situation for most people.

And so if there were alternatives to this route that he was able to take, which was heroic and very encouraging, I think that would be better because these people do not have Christopher Reeve's large amount of resources that he could sink into his rehabilitation.

So those are the couple of points I just wanted to raise.

DR. CALLAHAN:  Well, let me first point out I in no sense meant to imply that stem cell research is inferior, in fact, it may be superior to all the others.  I was simply making the point that NIH already is pursuing other things that they consider very promising as well.

Stem cell would be one more thing added to the list.  It might be better than the others, but unless we think they have been wasting money over the years, the NIH has believed that other things are valuable and worth pursuing as well.

With Christopher Reeve, you may well be right, but much of that research, the benefits came out of NIH-sponsored research.  How it got paid for with him, I haven't the faintest idea.

But, again, this gets back to Harold Varmus' point.  It may well be that a lot of the research will develop things that only well-positioned, affluent people will be able to afford.  But that is a side issue.

PROF.BLACKBURN:  I think the point was that his current one was such an expensive kind of therapy.  And if there were cheaper ones that might be more readily accessible, that would be -

DR. CALLAHAN:  Sure, sure.

CHAIRMAN KASS:  At the risk of perhaps deflecting people from where they would like to go, it seems to me the real challenge that Dan's paper and presentation throws out for us is to think really about the large theme, which is the moral imperative to research.

And I wonder what people think of the general thesis of the presentation as stated.  And the use also of informed consent at least indicates that, if I understand Dan's argument, there were certain kinds of trumping limitations that indicated that the imperative to research, if there were one, or at least the pursuit of research, if there were one, simply wasn't the sort of thing that trumped all other kinds of considerations, including moral considerations.  I wondered what people make of the general thesis that has been presented.

Frank Fukuyama?

PROF. FUKUYAMA:  Well, I appreciated that presentation because it really made me think about a lot of things, but it does seem to me that fundamental to your argument is actually not the question of the value of research per se, but the value of biomedicine directed towards basically curing diseases in old people that will add, say, another five years of life expectancy to a population whose life expectancy has already been pushed to a fairly high limit.

And the value of that compared to other things because you are willing to say, well, infectious diseases that affect younger people I guess in your mind actually do trump quite a lot of other moral considerations.

DR. CALLAHAN:  Not informed consent, however.

PROF. FUKUYAMA:  Not informed consent, but you're willing to concede that.  So it seems to me that that is really the focus of the issue, the relative value of biomedical research directed towards that particular population.  And that becomes, then, a kind of metric by which you can value one type of research over another.  Isn't that the basic -

DR. CALLAHAN:  I guess to me the fundamental question is, what are appropriate goals of medicine at this stage in history given the fact that we have already made great progress, given the fact that most people now die in old age, rather than as young people.  Where ought we to be going?  That's the basic question.

And at the same time, though, I want to say that I think it's been given an excessively high evaluation.  And I would simply want to bring it down a little bit and put it on a par with a lot of other things we could usefully spend money on.

CHAIRMAN KASS:  Frank, do you want to pursue that?

PROF. FUKUYAMA:  Yes.  I think that that's really in a way a core issue that we ought to discuss much further.  I remember once hearing the director of HHS saying that heart disease is down, mortality from heart disease is down, and a number of other diseases, but, unfortunately, mortality from these other diseases is up.

Now, it seems to me even the director of HHS should be able to figure out that the total of mortalities from all diseases have to sum to 100.  So that if you actually cure some diseases, you will be raising the rates of mortality from other diseases unless you can presume that they are not going to die.

So, really, what you are talking about is, in a way, this whole life extension issue and the kind of value that.

DR. CALLAHAN:  Implicitly, that certainly arises, yes.  Well, it's also there's another issue, which I have written about in another case and gotten in trouble for writing about, namely, what is our obligation to the elderly given the fact that the average age of cancer deaths is at age 69 or 70 now.  So it is clearly a disease of the aging.

Should we continue giving it the high priority it had by virtue of the fact that it's mainly older people who have it, as with spending on money on young people to improve the schools?  Which is the greater social contribution?

PROF. FUKUYAMA:  And I would just point out that among the complexities of that, you get into all of these quality of life issues.  One of the reasons that there has been this explosion in rates of Alzheimer's is that you have actually succeeded in other areas of biomedicine, keeping people alive long enough that they can get to an age where they are much more susceptible to that.

So it seems to me the total good that is being delivered to society by some of these advances is much more problematic.  And I think that's a perfectly reasonable issue to raise.

CHAIRMAN KASS:  Alfonso Gómez-Lobo and then Bill May.

DR.GÓMEZ-LOBO:  I have a concern and a question, but I would like to preface that with a broad agreement on your approach.  I think there's deep wisdom in placing the question within the ranges of goods.

And I totally agree.  I seem to see an emphasis on health, which may not be reasonable in the long run.  I mean, we are surrounded by other goods.  And we may be neglecting lots of other social goods by emphasizing that.

Now, what I think is very important is to say there is a limit to the balancing.  In other words, that balancing goods is something that is reasonable when the pursuit of those goods is morally permissible.  And there I think - and I totally agree with you - the notion of informed consent plays a very important role because that's the nonnegotiable limit, right?  You don't balance that in any way.

Now, here is my concern and my question.  I have seen since I have been on the Council and reading some stuff that informed consent is sometimes extended to the treatment of children and then also to the disposal of, say, frozen embryos.

What I am doubtful about here is whether there can be valid informed consent for actions that will not benefit the subject.  And I would love to hear some clarification of that.

And, of course, that ties into your last remark, the remark about the embryos having a weak moral claim.  And I want to ask you, what does that mean?  And if it's weak, how does it become stronger and say how strong would that be in an infant?  In other words, does the notion of varying moral claim for drastic action, like the action of killing, really make philosophical sense?  That's the question I would like to raise.

DR. CALLAHAN:  Well, your last question bears on the whole discussion, the rest of this meeting.  I mean, I could say a lot, but let me say very briefly I think by "weak moral claim," I mean a claim where we are uncertain about the moral status and we are uncertain about how great the harm being done to that moral status might be. 

By "weak claim," I mean a claim somewhere in between saying embryos are worth nothing and embryos are full of life we claim is one that is somewhere in between.  It is something.  It has some value, but we are not quite sure how much value.

And we may on occasion be willing to say it might be overridden by other considerations.  That's all I will say on that.  I would just as soon not have to get further into that.

I'm sorry.  You're first -

DR.GÓMEZ-LOBO:  The other point was about consenting to an action performed, say, on a child or on an embryo that would not benefit that child in -

DR. CALLAHAN:  Well, that's a hot area that has been disputed ever since the Nuremburg trials because there are incompetent people doing research and somebody with Alzheimer's disease doing research and children, people who are not in a position.

I think it's generally agreed that you may have to indeed do the research, it's valuable research, but there you have to depend upon a surrogate giving you permission, somebody you believe is competent and capable of giving permission for the research to be carried out on that person, the condition being that the person is not able to carry out the research and that the research would be beneficial.

Now, on your question of non-therapeutic research, I don't see any reason why a competent person can't agree to be part of research.  It is not going to particularly help that person.  I was part of a research project on amphetamines myself at one point.  It had nothing to do with my health at all.  And I think I was able to give informed consent on that subject.

So the question of consent for embryos, well, that's a whole totally murky kind of area.  I don't think obviously you can give consent for an embryo because you have no idea what that embryo might have wanted, where it's going, or anything else.  I am going to put that question aside and not even try to mess my way through that, which would be a confusing business anyway for me.

DR.GÓMEZ-LOBO:  Yes.  I'm a little bit disappointed, because that is exactly the kind of guidance -

DR. CALLAHAN:  That's not my charge at this meeting.  And I will give you references I have written on that, but I can't do it in three or four quick sentences.

CHAIRMAN KASS:  Bill May?

DR. MAY:  The paper and the presentation are offered with your characteristic reasonableness.  I would simply like to explore the question of the place that you give to research imperative in the setting of a metaphor, a fight against death and understanding of death as a contingent, accidental fact and, therefore, the tension between that research imperative driven by that military metaphor with what you call the clinical imperative, at least the old clinical imperative. You're talking about an imperative directed at doctors.  I'm not sure if that is what you mean or patients where the imperative is to accept death as a biological fact.

Now, it seems to me what this leaves out, that gives heft to the research imperative, is a further structural characteristic of death, that death is uncertain but uncertain as to time when—  Heidegger worked all of that out.  And behind that was Kierkegaard.

Uncertain as to time when creates a huge opening that allows one to give the impression that one is fighting against death.  But one really creates space for the avoidance of death.

We send people to hospitals so often because that is where the battleground is located and where we have got people equipped to fight against that.  And if they don't have all the resources behind them, it's research so that if it isn't successful with this patient, it will be successful with future patients, all of that.

But the other deep response to death is not simply fight but flight or avoidance.  And so the military establishment fighting against death offers an important psychological service to patients.

Yes, it's certain but in a sense uncertain as to time when this is going to happen.  And there are still tricks that the doctor will have and so forth, so that push in the direction of orienting even what goes on in the clinical setting, to if not curative efforts, delaying efforts and so forth.

Now, what this leads me to think about is a huge shift in the religious landscape from earlier centuries, a West shaped by a notion of a creative and nurturant God.

And purportedly the authentic life was to be open to this deity and then two forms of reaction to this deity, which were defined as sin, fighting against God, Luciferian revolt against God, and avoidance of his presence.  That was Philistine flight.  So you had a fight and flight response in relationship to the deity.

One might argue that the religious landscape of the last couple of hundred years has shifted over that the encompassing reality is not a creative, nurturant God but what James Joyce referred to as dio boia in "Ulysses," the hangman God, or Camus said, "The whole world is organized by death.  In the end, we're all done in."

And then you get people like Kubler-Ross saying, "Hey, let's be open to this.  And, indeed, being open to death, finally we're open to ourselves at our deepest level."  And she gave, in a way, Heidegger-on-the-cheap there.

But, on the other hand, the terrific attraction of fighting against death and, further, the compounding of that that you set up an apparatus of fighting against death that offers people the sense that we don't get heft to face it.  So avoidance, at a deep level, helps drive and give heft to the research imperative.

The way you have written this chapter, it seems as though the research imperative is driven by the military metaphor and then spills over into the clinical setting when I think the existential setting is quite the reverse for people, that it is certain but uncertain as to time-when.  And there were things to be done in the hospital that I can't do at home.  So you put them there and so forth.  So it allows one not to have to face it yet.

Now, yes, medicine ought to recover that old, old imperative, learning how to accept finitude and death.  It was very difficult to do in a setting where one really feels that ultimately one is facing a hangman God.

The kind of religious background, it seems to me, would ask one to talk about the drive behind the research imperative.  That may be at a deeper level and more complicated level of our attraction to it and the temptation to it.

DR. CALLAHAN:  Well, just a quick response.  It seems to me that, even if one accepts the reality of death, it's seemingly understandable that we would like to stall things a bit, take our time.

But this is true of a lot of things that are rather unpleasant.  We avoid and we flee.  When the doctor says, "Well, you have to have your tooth pulled," we say, "Well, how about next week, rather than tomorrow?" and so forth and so on.

I think the question of the research imperative is - the way I like to put it is whether we ultimately believe that death is kind of a biological accident, a contingent event that ultimately can be overcome as distinguished from simply forestalled.

And it seems to me that the whole trajectory of modern medical research has been basically to treat it as if it were an accident.  As far as I know, there are no fatal diseases that the NIH finds acceptable.  The NIH is not in favor of immortality, at least officially, but there are no diseases that kill people that it is prepared to tolerate.  And it puts money into research, any and all lethal diseases.  So the logic of that whole movement is -

DR. MAY:  Long before there was modern research, you got Frazer and "The Golden Bough" talking in traditional societies, a tendency to look upon death as an accident; or in Freud, the eagerness to find out the cause of death because it is an accident that befell somebody else and not me or you get the same thing again in Tolstoy's "Death of Ivan Ilych."

DR. CALLAHAN:  But I think with contemporary medicine, we get a new plausibility to thinking that way.  That's the difference.

CHAIRMAN KASS:  Rebecca Dresser, then Paul.

PROF. DRESSER:  I share many of your views and concerns.  And I think I am so happy that you are writing about this in your usual eloquent and elegant way.

I had two questions.  One is, you alluded to this but didn't speak to it directly.  Something that I think goes on is the equation of provision of proven health care with money for research in the political setting and sort of public ethical debate.

I take it you would see those both as goods.  And so then the question would be weighing and saying which should have priority, but I wonder if you can comment on how you might weigh those two, the provision of proven health care to more people who don't get access to it, versus money for research that might improve the health care we have available now, but at the same time leaving more people without it.

And then my other question was about procedures, sort of at a practical level.  If we are to try to make progress toward revising priority-setting in these social programs, any ideas how we might go about doing that and the role of lobbying and all of this?  Any thoughts in that direction?

DR. CALLAHAN:  Well, let me begin with your second question.  I like the system used by the British government.  Of course, they have the National Health Service.  It's financed by the government and run by the government.  But I gather that a part of their annual budget-setting is that the different social areas have to compete against each other.  They have an open debate:  education versus health versus economic development.

I would love to see that.  Even if done informally, I think it would be terrific if somebody could have a great television program getting people, leaders from the different sectors and say, "Okay.  You want more money for education.  Are you prepared to say less money for health?"  That would really put everybody on the spot.  I think if we could get that in open debate, it would be very valuable.

I think on your first question, I think one major reform that I am in favor of in the priority-setting area and in support of research is that we really now need to look very carefully at the economic consequences of research.

Right now recently Medicare had some hearings to look into new heart technologies that are going to very radically increase the costs of treating heart disease.  And the question is, which ones should Medicare cover?

Now, typically that is done more informally, rather than as a public debate.  I would like to see that done openly.  I suppose my most radical suggestion would be that those companies that manufacture new devices and new drugs must, at the same time as they are doing safety studies and efficacy studies, be doing economic studies and saying, "This is our projection of the economic impact of doing this" and before the technology is released.

The typical procedure now is technologies are developed.  And they're sort of thrown out of the window.  And they say, "Okay.  You health care administrators sort of deal with it.  That's not our problem."  And I would want to say we should make it their problem.

And I suppose if you want to go really far, you would say no technology or at least to be reimbursed by the government until it has had a very solid economic analysis and debate and some consensus on whether this is economically worth advancing.

Now, the typical attitude of researchers is, well, a) that's not really their problem; and, b), after a while, we find ways to pay for things anyway.  And this will hold up research.

Well, it probably would hold up research, but, an issue that didn't come up at all, I happen to believe that research is one of the main things that drives up costs, that right now we are seeing cost inflation 10 to 15 percent a year.

The estimate is 40 to 50 percent.  It's coming from new technologies or intensified use of old technologies.  If that's the case, then I think we have to very squarely face the problem of the research behind those technologies and learning how better to evaluate the new technologies that come on line.  And all of that is set within the larger context of comparing health with other things in society.

But I think more generally, it seems to me a really tragic situation when we have — to me, the worst arguments around are those on the part of the pharmaceutical companies that say, "We need these high profits to save future lives" when, by God, if they bring the price down, they could save lots of lives here and now in Africa by making their drugs available.

So that this notion of these wonderful lives in the future somehow comes at a discount rate for the future.  They're basically saying, "Oh, no.  These lives are worth more in the future than the present lives we could save now."  And the drug companies simply dodge that issue altogether.

CHAIRMAN KASS:  Paul McHugh?  I have a long queue.  I will try to get to everybody before the break.

DR. McHUGH:  Well, I also want to thank you very much and was looking forward to your presentation because I have read your work for a long time and expected, actually, to find just what I found this time, that I agree with so much I am surprised at what I disagree with.

Let me develop my disagreements, at least to the point of talking about them in practical terms.  I speak now as a person who has run a laboratory and also a person who has been a director of a clinical academic department.

In this arena that you have laid out for us of discussing the value and the value of research in relationship to, is it a moral good, or is it an imperative, you first wanted to talk about it in relationship to cost.  And it's that point I want to bring up first, that even if it's a good, just a small good, anyone who has had any experience with research, basic science research or clinical research, knows what the problem for our country is in relationship to its financial support.

The growth of investigators and the growth of reimbursement is a Malthusian problem because laboratories grow and replicate themselves with their students in an exponential geometric way.

And anyone who has run a laboratory begins to notice that he or she has many of these wonderful postgraduate students.  They grow.  They become directors of their own departments.  And they become steadily more expansive in bringing many more opportunities to our world because of that.  But tax money and money from the country can only grow arithmetically.

So there is always going to be this problem that you raise.  Why is it that the legislature, the things closest to the people, closest to the citizenry, will always overrule the executive, ask for more money because more money is going to be needed for whatever, whether it is an imperative or a good, only to do that to our country?

On the other hand as well, it may just be my perspective about your work and your presentation here, and it might be just a prejudice on my part.  And so we'll accept that at the beginning, but you've got to begin somewhere with a prejudice.  And that is, how would I, who think of research as an obligation, a moral obligation, approach that from my experience?  And what is research or why research or how to judge research are the issues before us in relationship to is it a good or a moral obligation?  And I would like, of course, as you would, to produce, for example, one piece in this scale, namely the achievements in research over these years.

Now, you mentioned the wonderful achievements we have had, at least in recognizing the cause of the AIDS epidemic and developing very effective medications for them.  I lived, like any doctor who has lived, with the AIDS epidemic from its earliest beginnings right now, when everyone thought that nothing could be done because it was a viral illness, and now out to a place where I am taking care of a vary large number of people who carry the HIV virus but are protected from the things which were discovered.

In my area of work, of course, in psychiatry, the results have equally been remarkable, really, with research that is sometimes developed by accident but sometimes developed out of reason.

Those results are not just the reason for wanting to speak about it.  I also feel that both attitude and educational communities do not thrive unless there is research going on within them.

Again, I ran a clinical department.  And the very great importance of mingling investigators with the clinicians was to raise the standards of care offered to the patients and very much raise the standards of discourse amongst the clinicians about what they were doing and why they were doing it.

Now, in psychiatry, we have this in vivid terms described to us, demonstrated to us by the neglect of research during the psychoanalytic era, what Ed Shorter has referred to in his book on the history of psychiatry as the great hiatus in psychiatry when during the psychoanalytic era, essentially no research was done because everybody thought they knew the answer.  Okay?

The result of that era was the neglect of patients, the development of snake pits, the concentrations purely on the worried well, and the loss of opportunities in neuroscience and pharmacological work to do it.

And for psychiatrists like myself, I have come to believe that there really is an absolute moral obligation to have this in our discipline and in our departments.

And, finally, the very attitude that all of this ultimately produces for us is an attitude of not only optimism for the future but also an attitude of criticism for our views at the moment.

So for all of that, I think you have laid out a very interesting point.  I have to say that there are some fairly fundamental disagreements that I have with the conclusions you came to draw.  I hope you will accept it in —

DR. CALLAHAN:  Well, I guess if you want to continue to use the word "obligation," fine.  But then I would ask you, is the obligation to do research in your field — and it is not a coincidence that you feel it in your field and not my field.  I feel an obligation for philosophical research probably as strongly as in psychiatric medicine.

DR. McHUGH:  Oh, I think that —

DR. CALLAHAN:  I put that aside.  But how do you compare with the obligation better housing, community, national defense, safety nets?  I mean, my question is, do you want to give it an overriding priority?  Do you say that this is worth far more money than anything else or it ought to be put on the scale and compared with the other obligations?

DR. McHUGH:  Well, you know, once again, in a democracy, we have issues of competing obligations, competing with values.  And my assumptions are going to be that we should be trying to meet all of those obligations as we see them and as we interpret them.

That is how I am going to do it.  And that is why I am in America, where we can earn the money to do it.

CHAIRMAN KASS:  Michael Sandel?

PROF.SANDEL:  Well, this follows, Dan, on your discussion with Paul just now.  I think there is something needlessly puzzling, confusing about the pieces you present that obstructs what I think is really a very important insight that you are directing us toward.

So let me first say what I take to be one of the really interesting directions that you have given us and then say what I think is puzzling and wrong-headed about the way you have put the thesis.

By calling into question the research imperative, you have raised a bigger question lying in the background, which you mentioned at the beginning of your talk, about the inflation of health as a moral and social good in our society.  And Bill May gave I thought a fascinating interpretation about the existential landscape that might partly account for this dynamic.

There may also be — and this is just a speculation - a shift in the moral and public culture that contributes to this.  It might be that the more reluctant we become to pass judgment or publicly to affirm what makes lives worthy or good, the more likely we become to affirm what we take to be all-purpose means to any lives.

So the inflation of health may be a reflection of a non-judgmental impulse that has entered into the moral and public culture over the past 40 years, roughly the time that you detect this inflation of health.

Health is something we in a pluralist society can agree on because we take it to be necessary to the realization of just about any ends that people might pursue, against the background desire not to affirm any particular ends as aims of lives.

And you have directed us to this whole question.  That may not be the best or the only explanation.  But you have directed us, I think rightly, to this very important phenomenon about the inflation of health as a social and moral good.

The thesis, what makes the thesis confusing and puzzling, even to those of us who want to sympathize with it, is that you really, as I understand, are saying two things.  First, there is no moral obligation to pursue medical research.  That seems to me wrong.  There is a moral obligation to pursue medical research.

Then you are also saying another thing, which you take to be the same, which is medical research is not an overriding good.  It doesn't trump all other goods.  It has to be balanced.  Well, that is surely right.  And I suspect everyone would agree with that, but those two claims aren't the same.  It's perfectly possible for something to be a moral obligation and still, as Paul says, for there to be competing moral obligations.

Consider other examples outside of medical research.  There is an obligation to educate the young, to prevent starvation, to save innocent lives where we can, to oppose injustice, to protect the security of the country.  Those are all obligations.  But to call them and to recognize them as such isn't to say that any of them is an overriding good in the sense that its pursuit trumps all other considerations.

So I think that you could win wide support for your thesis that medical research is not an overriding good.  It has to be balanced against other competing goods without making what seems to me a puzzling and unnecessary claim that it is not a moral obligation.

DR. CALLAHAN:  Well, the reason I was trying to deal exactly with that confusion, which is the difference between a perfect and an imperfect obligation, when people say there is a duty to do stem cell research, they're giving it a very special status.  They are saying that somehow: a) we ought to do it; and b) others can make a claim against us that they have a right that the duty be exercised.

I would want to say most of these obligations are rather nonspecific.  Yes, we have an obligation to raise children well.  We have an obligation to our national defense and so forth and so on.

But I guess I want to say that you can't use the language.  You can't make it a very specific kind of obligation because you then have to say, who is the one who has to carry it out?

If you want to say there is an obligation to carry out research, who has the duty to do that research?  Do we as citizens have a duty that we must put up the money for it?  Does the researcher, young researcher, have a duty that he must go into the field that will deal with XYZ problem?

It's narrow and very specifically goal-directed.  The imperfect obligation it seems to me is the more general one.  So I put it in the category of the imperfect, not the perfect.

CHAIRMAN KASS:  Very quickly, Michael, we're at the break time.  Let me ask the remaining people.  Dan, are you okay for another ten minutes?  I know you have a plane to catch?

DR. CALLAHAN:  Yes.  Unfortunately, I came from vacation on an island in Maine.  You can't get there from here or back to there from here without leaving soon.

CHAIRMAN KASS:  Seven minutes?

DR. CALLAHAN:  Yes.

CHAIRMAN KASS:  We'll ask people not to run over so the people in the queue can speak.  I have Gil, Mary Ann, Janet, and Dan Foster.

PROF. MEILAENDER:  Just quickly, Dan, I wonder if I can get you to think with us just a little bit about the structure of your argument because it seems to me there are a couple of aspects to it.

The one aspect that flows out of the language of imperfect obligations is to start from goals, really, aspirations that we seek to realize.  And there are many such goals that we think of as goods.  And we often, contrary to Paul's American optimism, we can't fulfill all of them.

That in some ways becomes a process of political argument, then.  And that's, in fact, what you have advocated.  You would like to see more overt political argument.  There is not necessarily any single answer that has to be given to how we should weigh defense and medicine and education and so forth.

It is also true, your talk about informed consent suggests that in terms of the means to those goals, that there are occasions when, even when a clear good could perhaps be realized, one has to forego it simply because the means to it is prohibited.  And that's what the principle of informed consent accomplishes.

I just wonder if that doesn't need a little more emphasis than you gave it, in a sense.  If there is not a research imperative, to use that language, then I don't think the primary reason is that we have a number of goals which we have to weigh and that sometimes health care might come out not at the top.

The primary reason is that we have accepted, and I think in some ways the research community has accepted, the fact that there are certain things that ought not be done even to achieve a certain kind of undisputed good.  That's where you simply can't claim that there is an imperative to do it because there is some other imperative that really does trump it and is overriding.

So, insofar as there is not a research imperative, it seems to me that that fact grows primarily out of prohibited means, rather than simply out of conflicting ends or goals.  Doesn't it?

DR. CALLAHAN:  Well, it seems to me that you can say that informed consent itself is a kind of moral imperative.  And it's over against the research imperative.

I guess I want to argue that the research imperative is troublesome when it is taken to have the power to overcome those moral obstacles.  That's when it seems to me it causes trouble, moral trouble.  And it basically says it is such a high goal that the means don't matter, that it is worth achieving because what you are doing is of such ultimate good.

PROF. MEILAENDER:  But you've actually got a duty of perfect obligation in the requirement that you respect informed consent.

DR. CALLAHAN:  Well, in that particular case, because you have a trust relationship between a doctor and a researcher and a research subject, in that case, you have a situation of perfect obligation because it is a much more narrow contractual relationship of -

PROF. MEILAENDER:  Not just because of the narrow relation.  Because every human being has a right to claim that over against potential researchers.

DR. CALLAHAN:  But that's exactly the point.  They have a right to claim it against researchers because we agree that there is a particular relationship that ought to obtain between researcher and subject.  And we, therefore, have put it into the category of a perfect obligation; whereas, earlier, I think it was not seen that way.  That was what the whole debate was about.

CHAIRMAN KASS:  Mary Ann and Janet.

PROF.GLENDON:  I want to thank you very much for giving us your expansive vision of bioethics as including, among other things, the ethical dimensions of the choices we make about what social goods to pursue, and I just want to see if I can make a little extension of your argument.  You have told us that research is a good to be pursued among other goods and that there are difficult problems of choosing among those goods.

The extension I would like to make is that in setting priorities among those goods, if you don't set them thoughtfully, and after deliberation, then they are going to be set by default or by the influence of special interests.  Would you accept that as -

DR. CALLAHAN:  Oh, absolutely.

PROF.GLENDON:  And so some of the references you made to what happens in other countries suggests that there is more of a process of deliberation and balancing in some other countries than there is here within the democratic forum.

Of course, a cynical side of me says, "Well, yes, European countries can, just as they do with defense spending, let us spend the big bucks on medical research.  And then they have the luxury of democratic deliberation about education," et cetera.

Nevertheless, the question I come to is, why do you think it is that it is so difficult in these discussions to get a public debate or even a legislative debate of the type that you mentioned happens in England, a discussion of the pros and cons of pursuing the various good things in a world of scarcity?

DR. CALLAHAN:  Well, to me the great difference between Europe and the United States is, at least as far as health is concerned and a lot of welfare programs, the government actually runs everything.

They either control the financing or financing and delivery as well.  And that means they have to work within a closed budget.  And once you're forced to work within a closed budget, you then are forced to deal with priorities.  You're then forced to deal with rationing, saying some things are comparatively more or less important.

By virtue of our strange mixture of the public and the private, we have no way to have a rational discussion because you have so many different actors with different rules of the game.

I mean, the whole private sector can go out and develop all sorts of things medically and technologically, which are absolutely beyond the control of any government or any regulation; e.g., private stem cell research, private human cloning if they want.

Under those circumstances, it is very hard to set a budget.  It is very hard to have a rational discussion.  And it is very hard to have any kind of unified outlook that enables you to set priorities.

Now, the National Institutes of Health has set a priority discussion and for a very simple reason.  They have to live within a budget.  They get a certain amount of money.  And they then have to decide how to spend that money.  So priorities are forced upon them.  But we don't have a country that is run like the National Institutes of Health.

So that's why I happen to think government is a good thing in this area because the market does not enforce discipline.  The market forces profligacy; whereas, it is the government's and closed budgets for discipline and priority-setting.  We don't have it.

CHAIRMAN KASS:  Janet Rowley and Dan Foster.

DR. ROWLEY:  Well, I appreciate the thoughtfulness with which you have prepared the material.  I have to say that I have very serious reservations, some of which were already expressed in a sense by Paul.

To me, the use of research imperative implies that there is some direction of this imperative and an agreement to its goals, even unstated.  And it seems to me this does not reflect the real world of science or biomedical science as I have lived it for over 40 years.

Your statement just now about who is going to tell a scientist to do stem cell research, that is not the way science is carried out at all.  It is true it is carried out that way in companies, but in the academic world, which is where fundamental research is really flourishing, the scientists are the ones who have the intellectual curiosity and the creativity to say, "Isn't this an interesting question?" and to follow up on it.

I think Liz Blackburn is a wonderful example of somebody who was studying how the ends of chromosomes in yeast were formed and maintained and discovered the enzyme telomerase.  And now this turns out to be a very important enzyme in cancer.  But who would have expected research in yeast to then have that kind of applicability?

So there is no direction necessarily in medical research.  It is what scientists find interesting.  Now, it is absolutely true that many of the interests are channeled by research questions that are considered to be very important or research areas that are the hot topics.  And if you are a young scientist, that is what you want to do because that is where the action is.

But I just don't think that there is a research imperative.  So I think that your example of NIH and their following many different ways of Parkinson's, in part, that is because there is no good answer.  So you try all of the options, hoping that one or a combination of options will really give you greater insight that will allow you, then, the next step to go beyond.

And I realize you have a plane to catch, but I want to come back to Alfonso's question of non-therapeutic research on children.  I want to point out that our understanding now of how babies learn, of how infants learn, of how different aspects of the nervous system mature at different stages and allow infants to gradually respond and observe, is all done by research, non-therapeutic research.  And it has led to enormous changes on how we look on babies and how we look on intelligence.

So you have to put these in the context of what it is that you are doing, what is the goal.  It may not benefit that baby, but it sure is going to benefit babies down the line.

CHAIRMAN KASS:  Dan Foster.  Why don't we take both questions, Dan, and then we'll let you comment?

DR. FOSTER:  Well, I will give it to you that the Council seems to have their loquacious genes fully on this morning.  As a consequence, I am going to bring it back towards the mean by depriving the Council of my remarks, which were really of eternal significance, but I am not going to -

(Laughter.)

CHAIRMAN KASS:  Do you want to follow that?  Why don't you respond to Janet?

DR. CALLAHAN:  Okay.  I certainly wasn't claiming that the research imperative has goals.  The research imperative in its benign sense I simply mean has a very strong sense within the scientific community supported by the American public that research is a good thing that ought to go forward.  And we ought to put money into it.  And that's what I mean by the imperative, that this is a valuable thing that should be carried out.  That's all.

The goals are all over the place.  People have different goals at different levels and so forth, so on.  And, of course, you are someone who spoke for the research imperative.  Your scientific colleague said exactly sort of what I was saying.

CHAIRMAN KASS:  Council members, we have run over.  We have a guest waiting to speak.  Let's return at five minutes of 11:00.  Dan Callahan, thank you very much for being with us.  We're adjourned for 15 minutes.

(Applause.)

(Whereupon, the foregoing matter went off the record at 10:41 a.m. and went back on the record at 10:58 a.m.)

SESSION 2: STEM CELL RESEARCH: CURRENT ETHICAL LITERATURE

CHAIRMAN KASS:  This is the second session, "Stem Cell Research:  Current Ethical Literature."  As Council members surely recall, the formation of this council was connected to President Bush's decision announced in his address to the nation in August of 2001 to permit for the first time the use of federal funds to support research on human embryonic stem cells, this despite the existence of congressional statute, the Dickey-Wicker Amendment that prohibited the use of federal funds for research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to injury or death, risks of injury or death, greater than that allowed for research on fetuses in utero.

Among its other functions, this Council was charged with monitoring stem cell research; that is, following and keep abreast of all developments, scientific, medical, ethical, and legal, in this exciting area of research, embryonic and adult.  The rest of today's meeting is given over entirely to helping us fulfill that charge.

We are following and monitoring developments in the ethical argumentations on stem cell research, developments in the basic scientific research and clinical application, developments in the state laws, as these have taken place over the past two years under the current federal policy.

To aid us in these monitoring tasks, we have commissioned seven review papers:  one on recent developments of the discussions of the ethics of stem cell research, five on recent scientific and clinical developments in five separate areas of embryonic and adult stem cell research, one on recent developments in state law regarding stem cell research.

The ethics review paper was prepared by our guest for this session, Professor Paul Lauritzen, who is professor of the Department of Religious Studies and the director of the Program of Applied Ethics at John Carroll University in Cleveland.  Speaking only for myself, I would note with gratitude that Professor Lauritzen has tried in his paper to expand our horizon of the relevant ethical issues to include matters beyond the one that has so preoccupied us, namely the important issue of the moral status of the embryo.

I would like to welcome Professor Lauritzen, who will offer a beginning presentation, after which both the presentation and his paper will be open for our discussion.  Thank you very much for joining us.  We look forward to hearing from you.

DR. LAURITZEN:  Thank you.

Let me begin by saying I made the mistake of sending the slide show ahead of time and got a call from Dean Clancy last night wondering what the slide show and my presentation had to do with my report because I had decided not to simply summarize my report but to just highlight a few themes in my presentation.

And I suspect that Dean is a better and keener observer of human nature because he pointed out that perhaps not everyone would have read the report as carefully as I might have assumed.  But I wasn't going to write another presentation at nine o'clock last night.  And so I am going to give the one I wrote, which really takes some themes of my report and tries to highlight them by way of some additional data.  Mostly I am just going to read this.

Several people who have read the draft of my report have commented that for someone who argues that we should move beyond the debates about embryos and the status of the embryo, I spend a lot of time in the report talking about embryos.

At the risk of inviting that objection today, I want to begin with of slide that reproduces data reported recently from a study conducted jointly by the Society of Assisted Reproductive Technology and the RAND Corporation on the number and dispositions of frozen embryos in the country.  Forgive me if you have already considered this data, but it wasn't clear to me whether you had.

As you can see from the slide maybe and based on a survey of 340 of the 430 assisted reproductive technology practices in the United States, the documented number of embryos in frozen storage as of April 11, 2002 is approximately 400,000.

Moreover, the study was able to document the use to which these frozen embryos were designated by the IVF couples from whom they came.  Indeed, one point of the study was to determine how many frozen embryos are, in fact, available for use in the derivation of stem cell lines.

Despite the fact that many advocates of stem cell research call for deriving stem cells from embryos left over from IVF procedures, the authors of the study contend that so-called "spare embryos" are not a ready source of stem cell lines.

Of the nearly 400,000 frozen embryos in storage, apparently only 11,000 are available for possible use in deriving stem cells.  Although this seems like a large number of embryos, according to the authors, in fact, it is not.  And they break down that 11,000 along these lines.

Of those 11,000 or approximately 11,000, only 65 percent will survive the thawing process, leaving roughly 7,000 embryos.  Only 25 percent of that 7,000 will develop to the blastocyst stage, leaving roughly 2,000 blastocysts.  And only 15 percent of those blastocysts will yield viable cell lines, leaving roughly 275 cell lines.

According to this study, then, despite the large number of embryos frozen in this country, the number of potential stem cell lines available from their use is relatively small.

This is clearly an important study.  For one thing, it gives empirical grounding to the claim that we can derive stem cell lines from frozen embryos.  It is less likely to be widely cited.

My reason for beginning with it, however, is quite different.  I wish to highlight not the number of frozen embryos cited in the study but, rather, the date of the study's publication, namely May 2003.

As the study points out, the first live birth in this country from a cryo-preserved embryo was in 1986.  That means for nearly 20 years, we have had almost no idea of the scope of embryo cryo-preservation in this country.  Let me make two observations about this fact.

First, I believe it supports my claim that talk about respecting the embryo from conception is frequently more rhetorical than anything else.  If the early embryo is really to be treated as a being who deserves serious respect, you would think that we would at least know how many embryos are routinely frozen, discarded, or otherwise lost through IVF.  Not to put too sharp a point on it, but if each embryo were equivalent in value to a dollar bill, we would have lost track of nearly half a million dollars.

Second, the fact that until recently we knew almost nothing about the numbers or the dispositions of frozen embryos highlights just how unregulated the world of reproductive medicine is.

As this Council knows well and as the staff working paper to be discussed tomorrow highlights, the world of reproductive medicine is almost entirely unregulated.  Cryo-preservation of embryos is just one of the many developments in reproductive medicine that has been introduced as therapy without any sort of clinical trials and without any real oversight.  The significance of this fact in relation to stem cell research is that we have in reproductive medicine a model for what happens when commerce is wedded to desperation, when research is privatized, and when there is essentially no regulation.

More than one commentator has invoked the image of the Wild West to capture this scene.  The image strikes me as particularly apt, not least because the wild West was notoriously dangerous, at least as it has been conceived in the popular imagination.

There are clear dangers in the unregulated world of reproductive medicine.  I know there is some controversy about this point, but consider the report in the New England Journal of Medicine last year on the risks of major defects after ICSI and in vitro fertilization.

According to this study, infants conceived of reproductive technology were more than twice as likely as naturally conceived infants to have major birth defects diagnosed during the first year of life and were also more likely to have multiple major defects.  These were the odds ratios after the numbers were adjusted for maternal age, multiple births, and other factors that might have skewed the data upward.

Moreover, the increased risks were not confined to just one organ system.  They were found in cardiovascular, urogenital, musculoskeletal, and gastrointestinal systems.

Again, my point is not to focus on specific problems with reproductive medicine, as it is currently practiced, but to highlight a pattern.  Just as opposition to embryo research has led to the privatization of work on in vitro fertilization, with virtually no oversight or regulation of IVF, so, too, has it led to the privatization of stem cell research with similar results.

This is one reason I have noted the relation of IVF and stem cell research in my report.  The other is that I do not think we have fully appreciated the deep tensions between the widespread acceptance of IVF and a widespread profession of respect for the early embryos.

A foolish consistency may be the hobgoblin of little minds.  And Emerson may be right that such a consistency is adored by statesmen, philosophers, and divines.  But consistency in ethics is rarely foolish.

I have no quarrel with Emerson's advice to speak your mind forcefully today, even if it flatly contradicts what you thought and said yesterday.  My concern is that we speak out of both sides of our mouths simultaneously when we say that destroying an embryo is killing a person or that, indeed, the early embryo deserves profound respect and also say or act as if discarding embryos in IVF is non-problematic.

I tried to illustrate this point in my report by drawing attention to the cartoon comparing reactions to a stem cell clinic and an abortion clinic and then asking the reader to imagine that an IVF clinic is substituted for the stem cell clinic.  Here is the cartoon.

As you can see, the cartoon depicts protesters in front of a stem cell research lab, condemning those who worked there as being anti-life.  Down the street at the abortion clinic, the workers are noting how quiet things have gotten at the facility since the stem cell lab opened.

The point of the cartoon, of course, is that opposition to stem cell research appears to be almost as passionate as opposition to abortion and that there is perhaps an irony in the fact that pro-life advocates, thus, appear to be committed to demonstrating against research being done to find treatments for Alzheimer's, Parkinson's, and other devastating illnesses.

Now, try to imagine protesters standing outside an IVF clinic or, even better, outside maternity wings, condemning couples who use IVF as murderers or at least complicit with murder.  It is almost impossible to imagine this scene.  And it is worth asking why.

If the early embryo is fully a person, shouldn't we condemn IVF and work to prohibit it?  Is condemning stem cell research but accepting IVF not inconsistent?

Of course, one response to this alleged inconsistency would be to say that we should, in fact, be consistent in trying to prohibit both IVF and embryonic stem cell research.  I do not subscribe to that position myself, nor do I think it is a politically viable option.  But it would at least be consistent.

Notice, however, that a ban on embryonic stem cell research will not eliminate the many issues raised by the prospect of regenerative medicine.  And that is another theme from my report that I wish to highlight.

Although the ethics debate has mostly focused on the status of the early embryo and has, therefore, tended almost exclusively to issues raised by embryonic stem cell research, we need to take a closer look at issues raised by the prospect of adult stem cell research as well.

I have discussed some of these issues in my report.  And I merely list some of them here.  They include issues of social justice; of commodification or of commerce; issues about the conception of nature and what nature might mean; issues about human embodiment; issues raised by the erosion of species boundaries, so-called hybridization; and issues for implications of personal identity and moral responsibility.

Worries about eroding the boundaries among species, about destabilizing the concept of nature, and about treating human bodies merely instrumentally are related.

I believe that this cluster of issues deserves special attention going forward.  And, again, my point is that it's a cluster that is raised for adult stem cell research as well as for embryonic.  So that while we ought to continue debating the status of the embryo, we also ought to move beyond that debate to focus on these other issues as well.

I also think that we might do well, at least initially, to think about these issues outside of the contested question of human nature.  For example, I wonder whether there is some merit in considering the pervasive human manipulation of nonhuman animals.

For example, it may be useful to take as more than a curiosity the so-called transgenic art of Eduardo Kac.  Several years ago Kac made headlines around the world with his public art intervention that included Alba, the green fluorescent protein bunny.

As you may recall, Alba was an albino rabbit that glowed green under certain light because it had been genetically altered and carried a gene from a jellyfish.

Kac defined transgenic art as "a new art form based on the use of genetic engineering to transfer natural or synthetic genes to an organism to create new living beings."  And here is a slide of Kac with Alba.

Many people were outraged at Kac's creation.  And many dismissed his work as a publicity stunt.  But, in fact, part of the point of the Alba project was to generate a public conversation on the cultural and ethical implications of genetic engineering.

According to Kac, "The creation of a chimeric animal forces us to examine notions of normalcy, heterogeneity, purity, hybridity, and otherness."  Here is Alba glowing green.

The claim that I just read is a bit too jargon-filled for my taste.  That he did not use "alterity," instead of "otherness," is astonishing.  But Kac's work invites us to reflect on the implications of turning nonhuman animals into artifacts.  Of course, we have been doing that for a very long time.  Still, it's worth thinking carefully about our reaction to the creation of Alba.

It is worth asking whether our reaction to Alba is different from our reaction to, say, the creation of the Harvard oncomouse and i