Meeting Transcript
June 26, 2008

Council Members Present

Edmund Pellegrino, M.D., Chairman
Georgetown University

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

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

Alfonso Gómez-Lobo, Dr.phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Peter A. Lawler, Ph.D.
Berry College

Paul McHugh, M.D.
Johns Hopkins Hospital

Gilbert C. Meilaender, Ph.D.
Valparaiso University

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

Diana J. Schaub, Ph.D.
Loyola College

INDEX

• Session 1: Ethical Challenges of Expanded Newborn Screening
• Session 2: Ethical Questions in the Reform of Health and Medical Care
• Session 3: Ethical Questions in the Reform of Health and Medical Care: A Panel on Three Policy Proposals
• Session 4: Ethical Questions in the Reform of Health and Medical Care: A Panel on Three Policy Proposals, continued
  

   

Session 1: Ethical Challenges of Expanded Newborn Screening

CHAIRMAN PELLEGRINO: Good morning, especially to those of you who were right on time. Forgive me starting a minute or two late violating my own first premise. And welcome to those who are in the audience. We're delighted to have you with us.

One or two announcements before we start the formal program. We have two new members who are still in the process of being reviewed. And I think you're familiar with their names — Dr. Elshtain and Dr. Landry . I'm speaking to the Council members now who know about this. They're not here because they've not completed the entire process, which is rather complicated and takes a significant amount of time, more than we anticipate, usually.

I'd like to bring you up-to-date on the reports that we're working with so that you know there are coming very close to completion and we'll have several publications in the late summer or early fall and beyond that.

One is on newborn screening, and you'll be seeing a draft of that today or have seen it. The other one is on the definition of death, which is completed virtually except for one or two small items.

Also, we have completed the — the reason I'm having trouble, this is not one of those microphones you can turn on and leave it alone. You have to keep your finger on it, and —

PROF. SCHNEIDER: In order to shorten comments.

CHAIRMAN PELLEGRINO: I'm relaxing my finger from time to time, maybe when I have something I don't want you to hear. The organ transplant document, which is in a far advanced state but still needs reworking after you've made your comments on it. And we're very eager to hear from all of you, especially before we put it to bed. So we can look forward to at least three documents in the early fall.

And with the dignity volume and with others we're preparing before the end of the year, we will have completed our work we have in mind, and we'll have drafts for you on futility and on conscientious objection possibilities and problems in ethical issues and decisions by the professionals.

The two new appointments, as I said, we hope will be with us at the next meeting, but they will get all of the materials so that we'll have their input. And I think that's extremely important.

This morning we will pick up a discussion on the ethical challenges of expanded newborn screening, which has also been before us, and you have this document. And we're very much interested in having your comments, suggestions, so that we can put final touches on it, and this is an important document, I think, in the current situation. So I'm going to ask two of the members of the Council to open the discussion — Dr. Diana Schaub and Dr. Floyd Bloom . Diana , would you pick us up?

DR. SCHAUB: I want to thank Adam and Sam for another excellent staff working paper. They document just how dramatically the rationale for newborn screening has shifted. The 2005 ACMG report recommended a sizable increase in the number of diseases for which newborns should be screened.

And it strove to present that expansion as in line with the established principle that direct benefit to the newborn child should be the paramount and indispensable criterion for inclusion of a disease in a uniform screening panel. However, as the staff paper shows, the recommended expansion was not simply in number, but in kind.

We don't just have more newly eligible diseases being passed through the screen. We have an altogether new screen and a new justification for that screen. The old rule was screen only if you can treat. The new rule, although not yet so forthrightly expressed, is screen unless there is a compelling reason not to.

The adoption of this new rule seems to have been driven by a technological imperative and a research imperative, rather than, say, a strictly medical imperative. The paper details some of the ways in which the selection of disorders was skewed by the evaluative role given to the technology of tandem mass spectrometry.

So, for instance, 200 points were awarded to a condition just for being detectable using a multiplex platform. The privileging of the full profile mode, which will sooner or later be even more complete when DNA profiling replaces the existing platforms, is linked to the ACMG's redefinition of benefit. Benefit is no longer limited to direct treatment of the child, but includes notions of public benefit and, in particular, the progress of biomedical research.

The authors describe this transformation in strong terms, stating that hitherto for diseases that were poorly understood or for which no effective treatment was available, we as a nation have not been in the habit of subjecting individuals to mandatory screening merely for research purposes. Is this a habit we are now content to acquire?

It would seem so since the call for expanded screening has been answered by the states to such an extent that we are well on the way to a uniform system. According to the staff paper, the lone holdout is Washington State . Interestingly, not a state that I think of as backward. So why should this reputedly progressive state resist expanded screening?

The paper by the U.S. Preventive Services Task Force, included in our briefing book, points out that Washington and Massachusetts are two states that conducted structured reviews of scientific evidence as a result of which their state programs mandate screening for far fewer conditions. Thank goodness for that glimmer of independent-minded federalism.

I'm very much in favor of the Council moving forward with this report. Now, I think, may be one of the last useful moments in which to raise serious doubts about this incipient ethical shift in newborn screening.

My own preference would be for a return to the principle of “screen only if you can treat,” and I hoped that the final report would focus some attention on the downsides of screening, especially the effects of false positives, particularly when, as a number of experts have testified, the positive predictive value for any newborn screening test is less than 2 percent.

I wouldn't be opposed to providing an avenue for ongoing research on a wide array of disorders that don't meet the stringent criteria for mandatory screening, but if research is the aim, then in my view participation should be voluntary and informed consent of the parents should be required. Neither the technological nor the research imperative justifies state-ordered profiling of every newborn infant.

CHAIRMAN PELLEGRINO: Thank you very much, Diana . We'll hold comments until we've heard from Floyd Bloom and then open it up to the Council deliberation.

DR. BLOOM: This is going to test my eye/hand coordination to be able to do this. As they note in the preparatory paragraph, the expanded uniform screening panel proposed by the American College of Medical Genetics in 2005 and promptly endorsed by the Advisory Committee to the Secretary of HHS and thereafter by other groups has already been adopted in more or less identical fashion by virtually all of the 50 states.

Therefore, the first point I raise for discussion is what practical utility would be gained by having the Council speak out on the issue and declare whether it is ethically defensible to transition from the position “screen only if you can intervene” to the position “screen unless there's some reason not to” since it's already in effect in 49 states.

Can we expect to mount an ethical argument sufficiently persuasive to have 50 state legislatures reverse their prior commitments to the screening process or are there some constructive, congratulatory suggestions we can offer to state legislators who bought the ACMG's arguments in full?

We considered this question with an earlier draft in March, and at that point you had five chapters — "Trends in Newborn Screening in the Age of Genetic Medicine," "The Debate over Expanded Newborn Screening at Present," "The Debate over Future Newborn Screening," "The Case for Expanded Screening," and lastly "The Case for Caution."

And in my view this was a better way to report our diverse topics — our diverse views of the topic and the trends in the technologies. That draft had a much more neutral tone to the narratives than does the current version. The critical analysis is emphasized from the two Hastings Center reports that you gave us to read.

If we look at their arguments, while I'm sure, as we just heard from Diana , our Council's views are quite mixed, Bailey and Murray base their concerns on a five-year Hastings Center project that ended last year. That project examined general requirements for an ethical newborn screening policy and the degree to which the current technological capabilities conform to those ethical requirements.

They listed four concerns, which are summarized in one sentence: A newborn screening policy is ethically acceptable when it is evidence-based, takes into account the opportunity cost of the newborn screening program, distributes the costs and benefits fairly, and respects human rights. But these arguments are mainly rhetorical and without any data to support them.

Their conclusion was that there should be evidence on the scientific validity, clinical utility, and research cost of the screening test requires that the test be implemented and its cost and accuracy determined.

They say there should be evidence on the effectiveness of the research cost and the availability of treatment and that the positive and negative effects of introducing screening must be measured, aggregated, and compared.

While all that is at some level valid logic, operationally it's difficult for me to understand how heritable diseases can be detected before the onset of symptoms and pathology without starting with multiplex screening platforms.

Those are the kind advocated by Duane Alexander when he reported to us. Tandem mass spec methods can indeed measure multiple metabolic variants indicative of abnormal protein, carbohydrate, or lipid metabolism, but the future of this testing in my view and the arguments about cost opportunity will be set aside by the future higher throughput, higher sensitivity assays for direct DNA sequence diagnoses of the rare metabolic disorders that are mainly featured in the current primary and secondary screening panels.

More importantly to me, DNA testing will inform a variety of genetic markers for enhanced vulnerability to future diseases ranging from obesity, hypertension, cardiac, and other organic diseases to depression, schizophrenia, Alzheimer's, and even to those non-disease states that we all aspire to, namely successful aging.

What we might be able to speak to effectively are to encourage the pilot studies that Bailey and Murray note under their policy goals on pages 30-31 of their very long paragraph on those pages. I certainly agree with their premise that if the benefit of the screening is to anyone other than the infant being screened or that benefit is as yet uncertain, that parental informed consent should be required, along with a pregnancy-long educational process to help the parents make fully informed decisions with the knowledge that any genetic results will remain confidential to the family.

Whether such parental participation in the lifelong health- and wellness-oriented child rearing program can be made part of our concerns with the flawed current state of our health care system can be a topic for our second discussion today.

The second critical paper by Moyer, et . al , I find even less persuasive, especially given that the screening against which they are the most critical is the one currently adopted by the states. They focus only on the screening technology and questions of the current era and not those that one sees evolving into operational status tomorrow.

Given the unquestioned evolution of genetics-based disease vulnerability, comprehensive health systems will need the screening data in order to develop and apply preventative strategies. I believe in the ultimate evidence-based benefits beyond the infant being screened to family and society when they are implemented in light of the constraints of the Genetic Information Non-Discrimination Act of 2007.

Today's untreatable heritable diseases will never be treated unless we can understand the etiology, environmental and cultural influences, and the pathophysiology of specific genotypes. In my view, that all begins with screening. Let the heel stick blood blot be replaced by a buccal swab and whole genomic analyses.

CHAIRMAN PELLEGRINO:Thank you very much, Floyd . Before opening up for discussion, I'd like to ask if Dr. Adam Schulman and Dr. Sam Crowe , who had the responsibility for pulling together most of the research here — if they would like to add anything at this point. But before I do so, Adam , Sam , I have to apply a necessary benediction on our meeting.

It is not an official governmental meeting until I recognize the presence among us of our executive director, and I know that Dan Davis goes along with the benediction. So we'll just take it for granted, but we are now official and go on the record. Thanks a lot, Dan , for your help.

Now, Adam and Sam , do you have something to add?

DR. SCHULMAN: Yes, I will add a couple of comments in response to some points raised by Dr. Bloom . One point of clarification: The papers that we presented in the last meeting are intended to form the core of the first and third chapters. So there's nothing in those that will not be included in the final White Paper as currently envisaged.

And it is our — I think it's our purpose to try to lay out as neutrally as possible the issues — that is to say, present the case for and against the expansion and really leave to the members in their personal statements the decision as to which seems more plausible. So we will certainly do our best, especially in response to comments from this meeting and the past meeting, to include all the arguments on both sides.

I also mention about the question of what practical utility there could be to the Council weighing in on this point given that the states have adopted most of the recommended screening panel. As we discovered as we studied the ACMG report in detail, there are 54 diseases recommended, but really all but five of them could be justified under the traditional criteria of either being — either fully meeting the Wilson-Jungner criteria or being screened for as part of the differential diagnosis of those.

So really it's a question at this point of five illnesses, not all of which have been adopted by all of the states, and the ACMG is continually reviewing its protocols for expanding or possibly even contracting the recommended panel. And I think they are very responsive to suggestions and criticisms about how future illnesses ought to be added to the panel and under which criteria.

CHAIRMAN PELLEGRINO:Thank you very much, Adam . Sam ? No comment? Rebecca ?

DR. DRESSER: Thank you. I, too, think this is a very well written paper. I guess I have about three comments. One is another benefit external to the child that is cited in the Hastings papers is this benefit to the parents of knowledge and their desire to avoid the diagnostic odyssey. I didn't see so much on that particular justification in your paper, and so I wondered if you planned to address it. It seems to me that that needs to be addressed.

And it's interesting to me, it seems a lot of this is motivated by the advocacy of the parent groups and that diffuse organization. So sort of the role of advocacy in health policy might be worth mentioning. I'm not sure what you want to do with it, but it seems to me it underlies a lot of this momentum.

And then, secondly, I think as Floyd mentioned, there's this whole movement toward broader genetic testing or screening for everybody with this thousand-dollar genome people are talking about and pretty soon everybody will have this done and it will just be a part of primary care.

So it seems to me that in a way, if I understand it correctly, newborn screening is kind of going in that direction, too. And so maybe this is not so much a newborn-focused phenomenon, but a broader U.S. phenomenon where the increased ability to test for lots and lots of genetic predispositions is seen as exciting and positive and something we should move forward with. So I think that that particular angle would be worth mentioning, that sort of what's going on with adults and older children in terms of this sort of massive genetic evaluation.

And then, finally, this whole research issue. Of course, if someone wants to do research with the samples, they have to go through an IRB and meet the HIPPA requirements and so forth. So the implication in here was, well, research will just go on and the parents won't know about it and people will be identifiable. And, you know, I don't think that would happen.

So I guess it would be worth having a discussion of — and I don't know much about this, but I know people have written on how these newborn spots are used in research and what procedures have to be done before that can go forward. I think if it's anonymized, then you don't have to get permission, but if there's any kind of identification, they will have to get permission. So that seems to be worth putting in the report.

CHAIRMAN PELLEGRINO: Thank you very much, Rebecca. Sam or Adam , any further comment?

DR. CROWE: Thanks for your comments, Dr. Dresser . The research focus — we didn't mean to mislead you at all to suggest that there wouldn't be any informed consent. The idea was we wanted to show that behind the ACMG's — or within the ACMG's new proposal — there's a research component that's been added to a certain extent. And we only — and this is because the technology in some way picks or can pick up other kinds of diseases that aren't part of the differential diagnosis of the primary conditions they're recommending.

The idea would be that if a child has one of these diseases that's not part of the differential diagnosis, the physicians or technicians would report on those diseases and then offer the parents the opportunity to enlist their children as research subjects.

What we wanted to focus on, though, is that during the Wilson/Junger sort of criteria days, prior to the ACMG's report, the focus really was to find diseases that we could treat and not find diseases that we can't do anything about really or we don't know exactly what we can do about them.

DR. DRESSER: No, and I think that's very important, so I encourage that, I just thought maybe a footnote or something about what would then have to happen if somebody did want to go forward with research.

CHAIRMAN PELLEGRINO: Carl ? Professor Schneider ?

PROF. SCHNEIDER: I'm sorry that everybody has said these nice things about your report, because I wanted to say them first. I thought that it was really an exceptionally lucid presentation of some very difficult things.

I did agree that it was — it seemed to be quite tendentious. Over and over we were told, you know, should we abandon the old rock on which we have always stood, the it -must-be-for-the-benefit-of-the-child test. And I inferred from that that that would be a pretty perilous step to take. So if it is intended to be truly neutral, I didn't — I was not able to appreciate that as well as I should have been, I think.

I wanted to follow up on some of the things that Rebecca said. I find it very hard to say, "Here is the principle that ought to be used to solve all of these problems for the foreseeable future."

I know of very few issues which have been very satisfactorily resolved using only one principle. Prior commissions have often been content to use only one principle, and the result you see is some of the serious flaws of bioethical policy that we're contending with.

I'm persuaded that as to each thing you might screen for, there could be quite a complicated set of considerations, including not just, as Rebecca says, the interest of the family in avoiding the diagnostic odyssey. I can't see a difference between the interests of the family and the interests of the children in that case in avoiding the diagnostic odyssey.

So I'm nervous about the idea of saying "Here's the great principle. Apply it. Keep other things out of it." But I was quite struck by the Bailey and Murray story that they began with because it seemed to me to exemplify a systematic problem with the way that we make choices about medical care.

That article, as you may remember, was the story of the very sympathetic father in Mississippi whose child could have been screened and wasn't screened and he goes to the Mississippi legislature and says, "For God's sake, we have to screen," and they passed one of these acts I believe named after the poor child.

And the trouble with this is that this is the way that we make all kinds of decisions about policy, from a very one-sided kind of perspective without looking at what the costs of what we're doing are.

And it happens in at least two kinds of ways. One of them is the way that Rebecca knows more about than I do. The amount that is spent on research depends in significant part on how successful the patient advocacy groups in that area are, leading to some very strange proportions in amounts spent on research.

The other way in which we systematically distort decision-making is that we appoint agencies to be responsible for worrying about some aspect of health care. So you have HHS, which has an agency which cares only about health care privacy, and they issue regulations intended to maximize health care privacy in ways that seem quite uninterested in the costs of the operation. We have another agency, OHRP, which is responsible for, as they see it, protecting subjects of human subject research and only doing that, whatever harm that may do to useful research.

So I agree with Rebecca that this looks in many ways like a small part of a much larger irrationality in the way that we make health care decisions in areas related to the kind of things that the Council is worried about.

CHAIRMAN PELLEGRINO: Thank you, Carl . Ben ? Dr. Carson ?

DR. CARSON: Well, you know, I think obviously we're only in the infancy when it comes to these screening techniques and the things that we can screen for. So this is certainly not something that's going to go away in the future no matter what we say.

You know, I like to think in terms of analogies, to put things in clear perspective. And, you know, within five years there's a very strong chance that one or more of us sitting at this table will be dead. Now, would you like to know if it's you and when you're going to die? You know, how would that change your life?

Now, some people would say, "Yes, I'd like to know exactly when that's going to be, because, you know, it would certainly change the way that I did things." Some people would say, "That's the last thing I want to know." So I'm not sure that that's a moral or ethical issue, because it's going to affect different people in different ways.

And I guess the real issue is how can or whether we can actually regulate the way that the information is used, because the information is going to be out there no matter what we say.

CHAIRMAN PELLEGRINO: Thank you, Ben . Bill ? Dr. Hurlbut ?

DR. HURLBUT: Floyd, I agreed with quite a bit of what you said in a broad sense, but did I understand that you feel as though eventually we should have a uniform national policy of sequencing the whole genome for each newborn?

DR. BLOOM: Well, that's what I was implying and I think that's where the future is taking us, but it doesn't necessarily have to be a federally or a state supported system that will do that, because as this month's issue of Nature Medicine indicates there are already three very thriving firms offering to do that for individuals at any age.

But I think ultimately if we consider what's wrong with our current health care system and try to implement something along the lines of prevention rather than waiting until the disease happens, we're going to need to have that information as early in the life course as possible in order to understand how best to go about the possibilities of prevention.

DR. HURLBUT: Well, that's a good answer, and it's your latter sentence that I think is something we should pay attention to, because why would it be a newborn. If it's early in the life cycle as possible, why would it not be prenatal. And you actually mentioned in your opening comments a pregnancy-long education process. How about one that's informed with early testing?

And as probably all of you know there are advances being made in taking the peripheral blood from the mother and detecting either DNA fragments or even fetal cells. So this may not be invasive and not carry any risks.

There are some troubling dimensions to this, however, and I think they could be included properly in our report. I agree that the thousand-dollar genome is imminent and I think sooner than most people are — even professional publications are stating. And maybe then it would go down to the — who knows, maybe the hundred-dollar genome eventually.

And if I understand it right, the tests currently cost about $70. Is that what was implied in our report, Adam ? The mandatory screening that's currently in place in 49 states, roughly $70, $100?

DR. SCHULMAN: I think that's the right ballpark, but I'm not certain.

DR. HURLBUT: Okay, first statement — you must have this somewhere in your report already, but you should remember that's a huge amount of money — I mean, if, what are there, 4 or 5 million births a year in America. If it's a thousand-dollar genome, as you suggested, that would be 4 or 5 billion dollars a year. That's a significant amount of money to work toward cures and who knows what information we'd get from it.

But there are several things I'd like to say over the course of the discussion, but so that I get right to the heart if it is, do you think, Floyd , that it should be a mandatory — ideally you'd have that a mandatory approach?

DR. BLOOM: What I said was that I agreed with Bailey 's statement that if it was beyond the benefit of the child being screened that parental consent should be required and that the results should be kept confidential. And that would be along the lines of the IRB currently allowing for research on blood blots in an anonymized fashion.

DR. HURLBUT: And benefits to the child being a direct medical treatment or knowledge that the parents would have which would be preventive or some statistical possibility of the emergence of the disease? I mean, you know as well I do, knowing the science, that this kind of information that you'll get from a thousand-dollar genome, especially in the early decades, will be framed in statistical terms.

Some of the statistics will be hard for even the most informed scientists and physicians to understand and that's going to put an enormous burden on the average person in terms of what has been called toxic knowledge, information they simply don't know how to process no matter how much education you give them. Maybe we should just speak to those issues a little bit.

It seems to me this is what we're supposed to do as a Council is to talk about it no matter how we feel about it, but since you think this is a good idea, maybe you should address some of those questions.

DR. BLOOM: Well, calling it toxic knowledge already sets it up in a context that I'm not sure I agree with. We've have that kind of knowledge that — right now people with the Huntington's disease gene may or may not pose the same question that Ben raised earlier. Nancy Wexler, who talked to us three or four meetings ago, has a wonderful story that she often talks about of children who refused to be tested because they were sure they were going to get it and led their lives in a way that they later regretted because they didn't have the gene and mothers who have the gene aborting early fetuses and then deciding they didn't care anymore. So that toxic knowledge has been with us for a long time.

The Tay-Sachs disease gene in the Ashkenazi community was seen as toxic in the beginning, but the community rose to the occasion and now Tay-Sachs disease amongst Jews is extremely low in incidence. So I think the community has to be brought along.

We're not going to be able to deny the knowledge exists. And complex genetic disorders are going to be the mainstay of the kinds of diseases that Paul and I have been concerned with for our entire careers. And I don't see a better way to get at that knowledge than having the genetic sequence information as early as possible in the disease course. That doesn't mean it's going to be implemented in time to help my grandchildren, but my grandchildren's grandchildren will benefit from that.

DR. HURLBUT: I certainly didn't mean to imply that I thought this all was toxic knowledge. I just meant that that dimension for which the average person can't assimilate, that becomes to that person a burden, that we should address the issue of that, I think, because beyond the difficulty of dealing with false positives or statistical probabilities that are hard to explain — and, by the way, how far would you take it? Would you do not just the genome, but the epigenome also?

DR. BLOOM: It's not a slope on which I'm willing to put my feet.

CHAIRMAN PELLEGRINO: Dr. Schaub .

DR. SCHAUB: Yeah, just a question for Floyd . I initially thought that we were pretty far apart on the spectrum on this one, but I'm not actually so sure that we are, because you spoke quite favorably of this notion of having pilot programs and parental consent.

So, I mean, would you be in favor of the mandatory program, the state-run program, operating according to the original principle of screen only if you can treat and then having a sort of second tier program that could operate according to a different principle and screen for everything, but that would require parental consent and all of the sort of educational framework that would have to go with that?

So, Carl , you suggested that there had been, you know, a suggestion floated that we just operate according to some monolithic principle. In fact, I think that's not at all what I was suggesting, but that you could have a kind of two-tiered program that would take proper account of when consent should be sought.

DR. BLOOM: I'm in favor of two tiers, but I'm also in favor of looking beyond where we are now to a much more complete, comprehensive, accurate, and sensitive profiling when DNA testing becomes the mainstream, rather than tandem mass spec or other direct measurements of abnormal metabolites.

And I would assume that the ACMG will continue to evaluate the state of the testing arts and the opportunities for the future so that the current panel, even though it has things that may not benefit the person being screened, will inform medical research. And that's the angle that I would like to see. I am not in favor of screen only if you can treat, because what I really want to get at are the ones that we can't treat today.

DR. SCHAUB: But do you think that when you go beyond that screen-only-if-you-can-treat, you must secure parental consent or not?

DR. BLOOM: I agreed with the Bailey position on informed consent if it goes beyond the benefit of the child being screened.

CHAIRMAN PELLEGRINO: Dr. Meilaender . Excuse me. Diana , finished? Dr. Gil Meilaender.

PROF. MEILAENDER: As I listen to our discussion, it strikes me that in certain ways a more interesting question has emerged than just the question of this newborn screening policy. I think this is significant, though I do take Floyd's point that if 49 states have done this, we might be thought to be sort of arriving a little late on the scene.

That doesn't mean that it's not worth rethinking. It may well be worth rethinking, but there is a concern there. But the larger point — and maybe somehow — I mean, it doesn't mean that we can't do this, but we need to set this focused discussion into the context of a larger point that has to do with the purposes for which one seeks knowledge.

If I'm a researcher — which I'm not, of course — I suppose the more knowledge, the better. Even if I see absolutely no possible use for that knowledge right now, it's useful to have, who knows what may come of it.

If I'm a patient or even just a potential patient or the parent of a very little patient, the more knowledge is not necessarily always the better. This is a problem. There may be a lot of things I'd just as soon not know along the way because I can't process them or I've got nothing to do with them and so forth.

And if this problem is buried in the newborn screening issue here, the various comments people have made suggest that it's a problem that is only going to grow enormously over the next few decades, and so we might not be coming on the scene too late at all if we couch this in a way that not only deals with this focused issue of newborn screening, but tries to say something — I mean, we have to think about what exactly there is useful to say, but tries to say something about a certain kind of tension between what patients or potential patients want and need as knowledge and what research needs and how one sorts that out. I mean, I think if we do something with that larger issue, we might be able to set this in a context that would be quite useful.

CHAIRMAN PELLEGRINO: Thank you, Gil. Dr. Dresser ?

DR. DRESSER: Carl, I don't mean to put you on the spot, but I remember you did some work on prostate cancer screening and about the attitude that patients had toward it when sort of perhaps from a more objective viewpoint the value of the knowledge was questionable, but the way that the patients felt about it was different. So maybe that would be useful to share with us.

CHAIRMAN PELLEGRINO: Carl .

PROF. SCHNEIDER: It at least speaks, I think, to the idea that in some circumstances getting the informed consent of the parents for this kind of screening would be a useful thing. It strikes me as very unlikely that you will actually be getting informed consent from parents if you present them with the form and ask them to sign it or even if you try to explain it.

The study that Rebecca was talking about was 40 men in Ann Arbor , and we spent — a doctor and I spent as long as needed to give them the information that they needed to decide whether to be screened using the PSA test for prostate cancer. And we worked in a way that no physician would ever be able to work with a patient, and then we would ask them, do you want to be screened.

And either answer, of course, was perfectly correct. Nobody could agree on whether the screening was a good thing. That's why the official guidelines always have punted this to the patient and to the doctor. The answers we got revealed that the hour and a half or so that we would sometimes spend had been time wasted, because they responded to the question by consulting assumptions in what I called folk wisdom that they had, like, “it is always better to prevent a disease than to have to treat it,” which is no doubt true, but screening doesn't prevent diseases.

The thing that came easily to their minds was this principle of the American Cancer Society that they applied in ways that we didn't anticipate and understand. More broadly — and there were lots of these pieces of folk wisdom that they used, like, "Well, the PSA test may not be really good, but it's the most recent thing and you should always use the most recent thing."

The literature on informed consent is massive, and it repeatedly, invariably suggests that if the goal is really to give patients information so that they can make a well based medical decision, the success you have in communicating the facts runs somewhere between about a third and a half if the answer is correct.

And here you have parents, very recent parents, and what you're presumably trying to do medically is to help them deal with their child as well as possible. And I think a decision needs to be made about how much of that — of the scarce educational energy that you have for dealing with these people you want to spend on pretending to inform them about the screening choice and how much time it would be better to spend on things that would probably do a whole lot more good for a whole lot more children a whole lot more quickly.

CHAIRMAN PELLEGRINO: Thank you. Peter ? Peter Lawler .

DR. LAWLER: Right. This has been a fascinating conversation going well beyond the scope of the report, but I just think from the point of view of the parent because, like you all, I can't think from the point of view of the researcher, particularly — that, of course, a parent would want to know about specific diseases that your kid has that could be treated. This doesn't seem controversial.

But when you talk about the more comprehensive knowledge that will soon be available that Floyd was talking about, a parent would be presented with a whole bunch of statistical probabilities or risk factors. And this might, in fact, as has been said, be way too much knowledge, turning preventative medicine into indiscriminate paranoia, like "You don't get dessert because you have a slightly better than average chance of getting hypertension."

And so preventative medicine is good, but this explosion of information presented as statistical probabilities a parent might not, in fact, want because prevention could turn into paranoia. But, in fact, how could you turn this down if it were available. It would seem irresponsible.

So that leads to all the things Carl was talking about in terms of informed consent. It would be very hard, in fact, to say no, and it would be very hard, in fact, to know enough to know whether you should say no.

So, in fact, the question of informed consent is a big issue, the issue of the explosion of information and kind of — which will seem like quasi-deterministic information that, you know, you'll know what's going to happen in advance.

And even though it's not really that, as was pointed out, it will seem like that to the parent, that, in fact, I tend to agree that we will not prevent people — be able to prevent people from being burdened with this information if it's available at a relative low cost.

And so there are all kinds of interesting psychological issues there about whether it's better to know all that much. And is there really an ethical and public policy issue — will we be able to withhold this information effectively from people; will the very idea of consent really mean anything given that it will seem irresponsible to turn it down. And then I can go on, as Bill wants to, to talk about how all these issues are enhanced or inflamed once you get into the prenatal area, but I won't.

CHAIRMAN PELLEGRINO: Thank you, Gil. Peter, further comments? Janet ?

DR. ROWLEY: I don't know that I have anything very profound to say. I can speak from somebody who's been involved in genetics, at least as related to cancer and as somebody who does research, that I think that one of the points that Floyd made in terms of being able to advance our knowledge and ultimately to benefit patients is an important consideration.

And it is true that in mass spec analysis you can do whole genome-wide mass spec. So you're looking at all the proteins, whether they're the ones you're interested in or not. And if you find an unusual pattern that keeps repeating — which, of course, is difficult in rare diseases. It could just be a polymorphism.

But if enough of them are pooled together, you then can both find diseases, presumably many of them of genetic origin, but you also can have individuals who are knowledgeable and interested in that particular metabolic pathway involved in trying to figure out both what the errors are, but also then what the possible treatment is.

So you can say, well, this is knowledge for knowledge's sake or research for research's sake, but I think that's how much of — many of our discoveries have been made just by following that particular pathway. So I think that only screening for treatable diseases is too narrow a focus because what's treatable today or what's not treatable today may well be treatable tomorrow.

And particularly with the recent discussion here on informed consent, is doing a mass spec twice on a sample and only looking for defined things that you know about in the first sample and then looking at everything the second time. Firstly, you may not have enough sample . Secondly, it's at least twice as expensive as it would be otherwise.

And I think we're all brought up to say, yes, we're all in favor of informed consent, but as a practical matter, I'm not so sure that it's really the critical issue. I think, not to misuse any genetic information that is obtained is the critical issue and one hopes that the legislation that has recently been passed will deal at least with some aspects of that.

But just think logistically. If you say you're only going to screen for diseases that are treatable and in five-years ' time that number is doubled, are you going back to the legislature and say, "Well, now we can treat this, so now it should be mandatory, not voluntary."

I think that we have to put some reasonableness in the kinds of recommendations that we make. And I do think that we have something to say as a Council, if as Gil has been suggesting, it is expanded or at least in, say, the last chapter it's pointed out that many of the considerations are applicable to a far wider population, then that would be a sensible thing to do.

CHAIRMAN PELLEGRINO: Thank you, Janet . I have Paul McHugh and then Bill Hurlbut .

DR. HURLBUT: Could I ask a question of Janet ?

CHAIRMAN PELLEGRINO: Relevant? Yes, go ahead.

DR. HURLBUT: As a point of clarification, Janet , and for information for our Council record, would it be more meaningful in terms of the value of information to have a test of all the proteins and can you, in fact, with mass spectrometry actually look at a whole view, essentially like the equivalent of a genome-wide expression? Can you look at, what is it, ten thousand proteins or so forth . And, if so, is that information reliable or does it sequence through cycles that make it less information-rich and how much would it cost and when would you do this in the newborn period?

DR. ROWLEY: Well, my understanding is that the tests currently are using mass spec, and I don't know how many proteins are analyzed. I know that for our research purposes in leukemia, we're proposing to do genome-wide screening, which — of proteins. So it's whole cell protein analysis.

And it's extremely expensive, but it's also new, and there are very few companies that you can get to do this. And if you really did it on a larger scale, then the efficiencies and the economy of scale would come in.

And you're not looking at proteins. You're looking at peptides. And at least this is — I'm so far out of my field that I shouldn't be saying this, but it's my impression that you look at the peptides and then you know which peptides you expect to be in which proteins and which amounts and with the controls, you can see what appears to be aberrant.

CHAIRMAN PELLEGRINO: Paul McHugh ?

DR. McHUGH: Well, I also want to begin by thanking the office for the report. It was wonderful and very informative. And it spoke a bit to my conflicts, and I'm deeply conflicted in this arena in two ways.

First of all, I believe that the conditions that I study, in particular, the ones that emerge in early adulthood and challenge the rest of the life of those people will need us to understand them earlier in order for us to develop appropriate work for them and to understand what the mechanisms of their conditions are and the things which prevent and enhance it. So I'm in that area.

I also, of course, am a person who informs people of them carrying a particular gene, and if you work in a Huntington 's center like I do and have the problem of telling somebody this kind of bad news, you really know in the hardest kind of way what effects it will have on them.

So when it comes, therefore, to this area of infant information, I want the information as an investigator and very much worry about the information as a doctor and as a person caring for these people.

And what I liked particularly about the report was that it was emphasizing for everyone that there's a transformation of moral custom here if this new method comes into play. That's all I think we have to do for the public is to say, something has been transformed and it's important for you to know about it.

Then I was delighted with what Floyd said about, "Gosh, we're playing catch-up here a little bit. After all 49 states have done this." But I wouldn't worry too much about that. Forty-nine states are a lot of states, but I think it was 32 states that agreed that there should be involuntary sterilization of people who they believed at that time could be, as Oliver Wendell Holmes was saying, "Three generations of imbeciles is enough."

So the states do these things prompted not by careful thought about the moral transformations, but they do it in relationship to the bits and pieces of information they get from so-called experts — or true experts and the like — who become focused on what they do like I could be.

So I'm very pleased with the report and I'm looking forward to having an ongoing conversation like this from different perspectives as it needs to be when moral issues conflict as they do for me, personally.

CHAIRMAN PELLEGRINO: Thank you very much, Paul . Carl Schneider .

PROF. SCHNEIDER: I would be helped if the report could — and if anybody here could help me understand what kinds of costs we're talking about here. I can easily be persuaded that it is useful in terms of research to collect this kind of information, even if it doesn't go to parents. None of that bothers me very much.

But we happen to be talking about this area. We happen to be able to learn something by studying this area, but is this actually a good expenditure of our resources? Is the margin — if you start mandatory screening for a few things where you really believe that it's cost effective, is the marginal cost of screening for everything else so low that it simply doesn't matter, or do the kinds of cost the report does talk about eventually become so great that you'd really have to get quite a large return on your investment in order to make it worthwhile. So I'm interested in the cost/benefit question here and quite confused about it at the moment.

CHAIRMAN PELLEGRINO: Thank you, Carl . I think Dr. Davis would like to pose a question.

DR. DAVIS: I'll only do so after the Council is concluded. Has everyone commented?

PROF. MEILAENDER: I just wanted to add to Carl something that I'm not entirely clear about. You said — you referred to the use of "our resources." And I'm not sure whose resources. I mean, my understanding is some of this is publicly funded and some is not. That might make a difference to me, sort of, in what I think about it. So a little more clarity on that would be good, too.

CHAIRMAN PELLEGRINO: I have Professor Gómez-Lobo and then I have Rebecca Dresser . Did I see your hand flick up here, Floyd ? Okay.

DR. GÓMEZ-LOBO: This is sort of a comment from someone looking at the earth from the moon roughly, because, of course, I'm not in this field, but it seems to me that if I try to reflect on the bioethical issues involved, I see that there's screening in three different situations — screenings for conditions that we can do something about; screening for conditions that we cannot do anything yet; and then general scientific knowledge, which, of course, at some point may become useful or not.

And I see the drawbacks or the negatives in a limited fashion. Maybe I'm mistaken on this. I see that with informed consent a lot of these things could be done. And I'm not so sure about the toxic knowledge argument. I think that I'm inclined to say most knowledge is good, and it becomes toxic in very particular circumstances. And I'm not sure it should be a very weighty consideration in public policy whether some people might — or for some people the knowledge might be toxic.

So my last question would be to Diana, but I think we're very close to each other now, is under what conditions would you accept a shift to the new principle? And in a way it seems to me that you have already accepted this by speaking of the two-tier approach. But that would be my view. I think that from a bioethical point of view most of the arguments should be taken to really favor massive newborn screening.

CHAIRMAN PELLEGRINO: Diana , did you want to comment? Dr. Dresser is next.

DR. DRESSER: I wanted to talk about if we have a two-tier system in the mandatory part where it sounds as though we're going to say there should be benefit to the child or — I don't know if we're going to say it should be, but that that's traditionally been the goal — how do things like — and they'll have to make decisions about what to look for in the future. So what about late onset diseases — APOE4, Huntington 's.

As these things become easy to find, is this something that should be included in the panel and how — if it's pretty much done without parental consent, what are you going to say to parents about this kind of thing?

There is today this therapeutic gap they talk about where we can know about a predisposition, but really not do anything about it or in some cases — say, a predisposition to obesity or addictive behavior — alcoholism, abuse of something — okay, well, what effect is that going to have on people to know about that.

You know, we already know we shouldn't smoke and drink too much and all that. So this discussion of if — even if we do rest mandatory screening on the notion of benefit to the child, how should that be interpreted in the future. What kind of evidence of benefit, what kind of benefit, would be justified as a sort of a tipping point before — you know, to have it included in the screening.

And then for the research consent, if it's just a matter of saying, well, it's okay with me to have my child's blood sample used in research for the future benefit of kids in the future and there's no coming back to me or my child with information and no linking of identity, I'm not so worried about how well informed they are about that choice. I think that that could be a pretty simple choice.

Then if it's something where they're going to want to come back and find the child and look at medical records, well, that's a different level, so maybe there should be more informed consent there or that people should understand that this could mean information about your child's health status and could have an effect on employment and so forth, confidentiality is important and all that. So I guess those are just some nuances about a two-tier system that I think should be at least mentioned.

CHAIRMAN PELLEGRINO: Dr. Davis , your comment.

DR. LAWLER: Very quickly, after listening to Rebecca , I think there is a non-trivial argument for no mandatory screening, in fact, that informed consent should govern it all. Parents should have the option of opting out precisely because of the slippery slope from prevention to predisposition and so forth.

So is there anyone out there defending that now, that there should be no mandatory screening at all. I mean, parents should be encouraged and so forth, but they should be able to opt out in a free country.

CHAIRMAN PELLEGRINO: Dan ?

DR. DAVIS: Okay, just looking ahead very concretely to next steps, we do have one proposal on the table from Professor Meilaender about a more substantive and that is looking at the broader question of knowledge. Is there general agreement within the Council to do that?

We did have an earlier version that did that and so it would not take much to resuscitate that and bring that forward into this new plan, but just for the staff's benefit, is there general agreement that we should make that kind of revision? Okay. There have been a number of smaller suggestions I think that we can incorporate, but that will require a bit of rewriting.

CHAIRMAN PELLEGRINO: Floyd ?

DR. BLOOM: Well, if we did that, which I would favor, there is now a growing body of experience and data from the Icelandic DeCODE Study where the general population all volunteered to have their genomes analyzed. And the results of that analysis could be informative as to what we would do.

CHAIRMAN PELLEGRINO: And that's been in process for several years, hasn't it, Floyd ?

Any other comments? We have some time. Do you want to respond, Adam ?

DR. SCHULMAN: We did do some research on the experience of other countries with large-scale biobanking, including the Iceland case. And it's an interesting and complicated case, which is largely defunct at the moment because the Iceland Supreme Court decided that there were too many invasions of privacy involved.

And so it's a complicated situation where the country seemed very enthusiastic at first about compiling this information, but there were reservations expressed afterward. But we have a project ongoing that will be featured in this report about biobanking and the challenges of preserving privacy and consent while making maximum use of the data gathered.

CHAIRMAN PELLEGRINO: Bill Hurlbut and then Carl, and those will be the last — and Diana. Sorry.

DR. HURLBUT: I favor the expansion of the scope of the report as mentioned, and I think what we ought to do is center it around the question of the principle that governs the testing, which, whether or not direct therapeutic impact is the principle. I think you've done that in your staff paper today.

But I also think we should take seriously the troubling criticisms in the Moyer article. Did you guys follow up with those criticisms directly with anybody from the group that issued the study? What was it called? The College of —

DR. ROWLEY: The American College of Medical Genetics.

DR. HURLBUT: The American College of Medical Genetics. I mean, the Moyer article raises some troubling criticisms, and as Floyd says, they were themselves not exactly evidence-based in the article, although they may very well be. They may not have had space for what they intended.

But a secondary thing I think we should address besides the principle is the effect. And there I think we should take seriously the fact of when patients, the general population, hears a scientific statement, they don't necessarily have an easy time digesting it.

And we tend to hear things, and there are a lot of psychological studies that would confirm this. We hear things not as objective data-receiving machines, but as human beings with a weighted sense of significance.

And in the Moyer article they mention the effect of information concerning sickle cell anemia and the failure of large numbers of people to act on even very obvious information. So I know personally of cases where people have received prenatal diagnosis information where they've completely misunderstood it, and these were reasonably educated people.

And the burden of worry — converting pregnancy into nine months of worry is really something we should take seriously. Of course, we're talking about postnatal, newborn screening, but I think it's very likely this will extend itself, and therefore I agree with Gil, we should address the whole spectrum of this, as well as the practical impact on patients and the practical meanings of cost and follow-up, and the seriousness of this issue is quite deep, I think; whereas I want to also reaffirm that I agree with Floyd completely, that this will yield really wonderful, valuable information.

CHAIRMAN PELLEGRINO: Paul ?

PROF. SCHNEIDER: I just have a quick question. You said that there was going to be a discussion somewhere of biobanks and privacy and is that to be in this report or in another one?

DR. SCHULMANOF: Biobanks come up in the third chapter, which looks largely to the future, in part, just because in this country they're really only being done on a limited basis, but there is discussion of nationwide large population studies and we will be going into that in the third chapter.

CHAIRMAN PELLEGRINO: Diana ?

DR. SCHAUB: Bill 's comment took care of what I wanted to bring up. Thanks.

CHAIRMAN PELLEGRINO: Thank you. Well, let me thank all of the Council members. Each and every one of you participated in this discussion. You revealed the complexity of the issue. I think we all know that this movement is going ahead, and I think it's important that Council provide a systematic and orderly look at some of the issues.

It's clear that there isn't entire agreement on how we should go, but I think it's appropriate at this time, and as you all know, that you have the opportunity to provide an individual assessment, a personal contribution, to the issue and I would like to invite you to do that. As you look at this again, if you feel it should be added.

We're not going to achieve a consensus on every item — we all know that — but I think it's important for the Council at this point to say, "This is the state of the question" that the public can look at and can reflect upon and we know that things are going to change, but this is the present state. And I thank you all again very, very much, and especially Adam and Sam . We now have a break until 10:30.

Session 2: Ethical Questions in the Reform of Health and Medical Care

My task this morning is not to bring you a revelation or a series of tablets from the mount, but rather to open up the discussion and once again ask you, as you did so well in this morning's discussion, your comments, your directions on how we should go.

I have two fundamental questions to put before you and then a little bit of an introduction. The two questions we'd like to have you address are: should we pursue this subject further? And if we do so, how can the Council, given its charter and its general direction up to this point, best contribute to what is a very, very complicated and at times a vexed debate?

Up to this point I think — the impression I get — and I may be wrong — is that most Council members do not have a strong desire to get into the middle of the discussion about which program or remedy is the better or the best, to decide on one or the other. My guess would be that the opportunity to come to agreement on that question would be extraordinarily difficult and may well be beyond the expertise of some of us, including myself, certainly.

But the other way in which we could contribute is one, I think, that fits into our charter. What are the ethical issues, if any — because some doubt that there are such. What are the ethical issues of importance to public policy — in a sense before those policies are made, at least concurrently with them, and important, certainly, once a program is decided upon in how we evaluate that program from the point of view of its end and its purpose? [How do we determine] which is to be of use and help to the people of the United States, particularly those who lack easy access at the present time, those who are ill and aren't getting care? …{ I]n a way then, we'll be talking about two things, although everybody puts them together — medical care , which in a way is in the category rescue operations, human beings suffering, needing our help and, in addition to that, of course, health care , which is more a question of cultivating health, improving quality of life, and adding preventative medicine to the roster of things that should be supported in one way or another.

The arguments have always vacillated back and forth from the point of view of whether government, private mechanisms, or some combination thereof is best. And I would say most of the programs presented to us today fall in one of those three categories.

I would like to say a few words about what I think can be our contribution as an ethics Council, and that is to examine what the ethical issues are or would be, whether we think there are any, how we think they should be phrased, in what order, and so on.

I invite your input as you have provided it so well this morning so that those who are preparing this particular document for your consideration can get guidance. What has been done is a first part of such an approach, and that is providing the background information, reviewing a little bit of the history and something of the content of the various proposals. This in response to a request that Paul McHugh made some meetings ago to get a better grasp of what the debate is all about. And I hope I've said it correctly, Paul .

And we thought that was an important question. So we believe the first part does some of that. You have received that and already have it in your hands.

We plan to move in the following way: to take what you will be saying today, to roll it into the second part, which is: are there ethical issues and can this Council contribute in a constructive way, not by issuing apodictic statements about right and wrong, good and bad, but examining the questions of right and wrong, good and bad as they come out of a new program from this old program so that the public will have some guidance in what our issues may be. That clearly and simply is a proposal of what we'll be doing.

If I can belabor your patience just a few moments more — and I do mean a few moments because the new system of keeping your finger on the pedal while you're talking the may exhaust my energy requirements and all my phosphorylation processes may not be as efficient as they were 88 years ago. But in any case, there's enough left to keep the finger going for a little while.

What I'd like to do is list for you, if I might, again not to be included in any report unless they're kinds of things you think are useful or worthwhile, but the questions are most often posted and presented to me when I discuss this issue. I make no apologies. The reasons I get these so-called ethical questions — and I think they are ethical questions — is because I have a tendency to say that what we have never discussed in the 100-year debate over health care and medical care — it's 100 years — 1915, the American Association for Labor Legislation made its first proposal of an insurance system, and it was rejected roundly by objections from the AMA, objections from labor, from business interests, and so on.

Since then — and this is the subject of this morning; therefore, I can only mention it — there have been, as you know, oscillations between these various mechanisms, but I don't want to get into the mechanisms. But in each case there have been ethical questions. I've raised them, and I'm not going to give you a speech or exhortation on the way you should go.

I think one of the first questions — and these are the ones that were presented to me, remember, now. It's an unofficial survey with absolutely no statistical power, I assure you. But it does impel me to think about it.

First, why is it an ethical issue? Many, many people think it is primarily an economic issue, a sociological issue, a partisan issue, but I think primarily it can be for some an ethical issue. Why? For the very simple reason that it deals with human beings and what happens to human beings by decisions made by those… who make policy.

What's the impact on human beings? And when you're talking about something that needs to be financed one way or another and you talk about the kinds of things that are being proposed, you're dealing with conflicts of interest — conflicts of interest between those who are ill and desperately need help and those, on the other hand, who are not in that state and who are in a better state financially and so on, and for them it's a non-existent problem.

But if a policy steps into this and attempts to manipulate a little in the direction in the one or the other, there's a conflict of interest. Human beings — some human beings are being asked to make a sacrifice for other human beings.

I'm not here to discuss how one looks at this ethically, but rather [to state that] it is an ethical [issue]. In my own opinion, [reflection on] the ethical issues ought to precede the economic and political science prestidigitation for the new program, precede not in the sense of saying this is the better mechanism, that's a scientific question ( if economics is a science and many believe it is), or [a question of] sociology. That's a question which the ethicist doesn't look at.

The ethicist does look at the impact, the effect of what is a scientific decision on human beings in the vulnerable state of illness or in the vulnerable state of being on the margin of society or whatever it happens to be. Notice we're not talking here at the moment about people who are able to take care of themselves.

The second question ethically is, who is responsible for one's health? Many would hold very strenuously, it's the individual. Why does society or anyone else have to worry about that. And others on the other side would say, no, it's in the interests of the common good to have people who are ill and not able to flourish or not able to participate or on the margin. It reflects something about the kind of society.

Those are ethical questions. I'm not answering those questions, but the questions were posed to me, which I freely answer when I'm debating it. I'm not doing that now.

Another question is if there is an ethical issue, then how does it relate to the economic question, because obviously this is a matter of economic science and some would say, well, the ethical consideration should judge, evaluate the proposal and therefore the evaluation of the proposal is not just scientific. It's not just the question of how it works, but does it achieve its end — the improvement of the health of those who need it, rescue operation, or improves it for those who are not ill at the present time.

So I think without going any further, and I can do more, there are ethical questions in the minds of many people, and therefore it is not something that can be simply brushed away. In that argument there comes a serious question of whether or not health care should be treated as a commodity — that is to say, that its place, its quality, should be left to the operations of the free market.

Some people would say, yes, and those, and there are many of them, whose own interests would be violated by some program that did not rest on privatization. And so another ethical issue you have, as I said earlier, is a conflict of obligations and a conflict self-interest with something that transcends self-interest. These are ethical questions. That's all I'm trying to establish. Is it a commodity, or if it isn't, what kind of an entity is it?

Is medical knowledge a proprietary instrument that the doctor owns or the institution owns. Can he therefore — or she therefore — distribute it as he or she wishes. We have those who say that that is the case, that no one can say how we should distribute our capacity and our knowledge.

There are others who say, "Oh, no, wait a minute. Where did you get this medical knowledge? Oh, we know you paid your medical school tuition, but you dipped into 3,000 years of information. Those of us who are clinicians, like myself , have drawn on clinical observations of 3,000 years old, perhaps older than that.

We have, by the way, altered them in the light of certain new developments, but the point is, we have access to those developments, and most of those who paid for them came out of public funds. The NIH has done a beautiful job of philanthropy. They are not funds they themselves have invested to get a return.

So save your comments, Bill . We'll be glad to hear them later.

How, therefore, can we look at possession and proprietorship of medical knowledge. Am I my brother's keeper? someone has asked. Even my foolish brother? Don't we do harm to people by helping them in those circumstances? Don't we inhibit self-reliance, don't we reward sloppy planning, et cetera, et cetera. Those questions arise. They're ethical questions.

What kind of a society do we want to be? Do the values that are reflected in the way we have organized and deliver this element of the flourishing of human beings, namely their capacity to function and be free as possible, obviously with the limitations of our mortality. And what can we do to help under those circumstances? Are we emboldened to do so, and does the way we handle it reflect on a society that in some ways has closed out an aspect of human existence and humanity itself.

By what criteria, can we study and examine the proposed programs? And we'll hear about some this afternoon again. We've heard many, as I said, in a year and a half. One way surely is their efficiency, their productivity, their cost, their value, but another one is does it do the job? Does it achieve what we're trying to achieve with it? Is it contrary to or enhancing the well-being of human beings?

Is health and medical care an obligation for society? What is a good society? You know, when you look for a definition of common good in most contemporary bioethics texts, you find very, very little. It's an ancient concept. It doesn't get much attention.

But think about that. Are we not all in some sense diminished — an ethical question. Of course, all of these ethical questions, like the ones you discussed this morning, have an empirical foundation and any talk about ethics needs to be secure in the empirical foundation.

I have to repeat over and over and over again in my teaching of bedside ethics, do you have the facts straight before we start talking about what's right and wrong, good and bad. And I think there's a paucity of facts that are irrelevant to the ethical issues.

Well, I could go on and on. You can see the drift of my questions. I simply wanted to ask you to think about the ethical questions. Are there ethical questions? What are some of those ethical questions? And get your input for the members of the staff who will be drafting the second half of the report, the first half of which you've already received. And we urge you, each of you, to write, comment here, of course. We only have a short period of time, but write to us your impression of it. You are citizens of the United States , too. How do you see it?

Let me say that this has never appeared, really, in the public debate in 100 years. Yes, there have been efforts here and there, and I think — this will be my closing statement. I think that this Council, in keeping with its charter to examine the ethical issues in public policy, does have a responsibility to look at this one. I stand to be overruled, obviously, but I believe that and I think that we could make a contribution. Just as in your last discussion, not the final, absolute, total answer to everything, but rather what is the state of the question now.

No matter whether you think it's an ethical issue or not, there are enough people who are asking these questions, believe me. I'm besieged by them — enough people who would like some guidance in what is the state of the questions, what are the pros and the cons. And that leads me to a final footnote.

My efforts since becoming chairman have been to draw from you what your thoughts are. And I've always hesitated to say what I think because I think it should be a reflection of what the group looks at and thinks, and they've been tremendously helpful.

But at this point I thought I'd interject just a little bit of a — what we call in physiology, the vis a tergo — forgive me for the Latin — the force from behind. We're talking about the pumping action of the heart that pushes the blood throughout the body. And I think the ethics may be the vis a tergo . Thank you.

Carl , you look like you're ready.

DR. SCHNEIDER: After that genuinely inspiring introduction, to have nobody say anything would be too horrible. Let me just start by asking a question that I've asked before and don't really feel that I've understood the answer to. For whom are we writing?

I sometimes think I'm the only person in America who has actually read many of the reports of the Councils that preceded us. It's a long, hard slog, and I think there are very few sophisticated Americans who will have read any of those reports.

We keep saying we're speaking to the American people and helping them to understand important questions. It sort of reminds me of what somebody said to Gibbon — "Scribble, scribble, scribble, another great fat book, eh, Mr. Gibbon " Who is actually going to read these things?

CHAIRMAN PELLEGRINO: Well, Carl , I think that I happen to have a strong belief in the fact that if one addresses issues with clarity and brevity, not from the point of view of saying "This is what you must do, but here are the issues you ought think about," — I think a lot of people read those kinds of things.

And I think our dignity report tried to raise that question to the dissatisfaction of some and the satisfaction of others, and that's the way it is. And I think when you complete the documents you were talking about this morning on something which is a reality and is moving along, there's no question there's going to mass screening, they will have a basis for thinking about it.

Now, whether the people who read all the newspapers or see certain TV shows will read it, I don't know, but I do think thinking people who have an opportunity to influence the communities in which they live would read it. I'm surprised at how many people do tell me they have read the reports of the Council, the previous reports, and find them helpful.

So my answer is I don't have numbers to give you, and the other side of it, what is the fate of any government report? People have a certain allergy, right? There are endless, infinite numbers of shelves with dusty books on them, and we may join that generation.

But I think that we can't give up the effort of trying to influence, and I think the answer lies in how we write them and clarity and order that we move. I guess not many people agree with me, but …I do think that people appreciate having it laid out for them.

I don't know how many times I've been told the stem cell volume was an extremely valuable volume even though many people disagreed with it, because there was a laying out of the issues, and to the credit of the Council, many of you put in your individual personal communications.

I'd like to see more of that, and that's why I'm inviting you in the summer to give us a little of your time and write your perspective. Just pick one of those questions or better questions that you can phrase than I have phrased here and say something about it. Is it an ethical issue? No, it isn't. Is that a fair question? No, that's stupid. Say it. But please don't say it that way. I haven't answered your question, Carl , but that's my commentary on it.

Gil?

PROF . MEILAENDER: As you know, my general comment from the start has been one of some skepticism about this topic. I've described it as a black hole, and if you get into it, you never get out. And I think that — I'm still not persuaded that that may not be the case.

But if we're thinking about how to proceed and you want these ethical questions emphasized, then it seems to me that the Council as Council needs to do something more. The notion that we can — I mean, what we have in the draft here is — I think there's useful information there.

CHAIRMAN PELLEGRINO: That's the background. Useful background?

PROF . MEILAENDER: Yes. And I think particularly — what's particularly useful about it is that it makes clear that there's not, in fact, one problem. There are multiple problems and, indeed, to solve one may be to exacerbate another. And, I mean, I think that's a very useful thing to see.

But if then one says there are ethical questions that arise out of this, why don't each of you write something about it. In the first place, many of us will not have time. Some of us write that sort of thing more than others do. I'm just not sure that's helpful.

I think it's helpful — it's been useful in some of our previous reports when there have been personal statements appended, but those are personal statements commenting on or even occasionally spinning what the Council report itself has had to say. And so it seems to me that we as a body ought to try to say something about a few of these questions.

I mean, you know, the question about whether there's really a duty to — obviously there can't be a duty to make people healthy, but there might be a duty to provide medical care or something like that and that relates to the issue of personal responsibility for health care.

It just seems to me that it would work — if we're going to proceed — and my previous reservations are still sort of in force, but if we're going to proceed, then I think we as a Council would need to try to produce something to which then different people could react more briefly or off of which they could play and so forth.

I have real doubts about whether it's going to work simply to provide the kind of prolegomena information that we've got here and then to say, okay, go ahead and write about whatever you want. So that would be my reaction to the plan as you've sketched it out right now.

CHAIRMAN PELLEGRINO: Well, I very much agree with it, Gil. I think it's — said in another way, I think — correct me if I'm wrong — what I was saying, namely that we ought to look at those questions and lay some of them out. I wasn't suggesting that we would abandon what we're doing in getting something ready for you for September, but rather that we would be enormously helped if those of you who have thoughts, just as you have, would send us that material and we'd try to incorporate it, as we've done in other reports. Generally we put them out to you, you've made responses to us, and we've tried to incorporate them — not all of them.

So I have nothing but appreciation for the way you've suggested it. And I know you and I have talked about it, that you have a bit of a skepticism, which I think is justified. That's why I said they are questions, rather than apodictic statements at the moment.

I have Ben Carson next and then Floyd Bloom and Rebecca .

DR. CARSON: This is a Council on bioethics, and the “bio” part means life. The ethics part means right and wrong. And all the other things that we talk about — stem cells, cloning, organ donation — you know, you could go right down the list. What does it all point to? It points to life. It points to providing quality of life. It points to providing longevity.

And ultimately the most important thing that a person has is their life. And a subset of that is their health. So the issue of whether we should be talking about it or not seems kind of silly to me. I mean, obviously, it's the most important thing. It's the pinnacle in terms of who we are as a society — the most important thing we have.

Now, having said that, many of the issues that you raised obviously need to be discussed. The issue of personal responsibility, I, as a physician, find that to be almost an irrelevant topic, and I'll tell you why. There are very few physicians or health care providers who are going to walk away from somebody who's in need because they were irresponsible.

You can talk about it. You can say, "Yeah, well, they didn't do this, they didn't that, so they" — but nobody is going to walk away from them. And we just need to factor that into any kinds of recommendations or thoughts that are made.

I had a patient yesterday, and there were some insurance issues. They were from out of state and the administrators and the people were saying, "Well, you know, I'm sorry, but the surgery is going to have to be canceled unless you can come up with a certain amount of money."

And so the mother was going to go and draw out money from the child's educational fund in order to pay for the operation. The father had died the year previously. They were by no means wealthy people. And when I heard about that, you know, I just said, "Absolutely not. Tell that mother to put that money back. If I have to do the operation for free, I will."

But that's the way most physicians think, quite frankly. And therefore that's why I say it's an irrelevant issue and we have to come up with mechanisms that take into account the fact that we are a compassionate society.

It's one of the things that insurance companies have capitalized upon. They recognize that physicians are a soft touch. They realize that they're not going to deny people care regardless of what the situation is.

So I think it's incumbent upon lots of different organizations and bodies to also find a way to protect the health care providers. They need to be protected, because they're not going to protect themselves. And if they don't protect themselves, eventually the whole system begins to crumble.

If we develop the same kinds of systems that many of the other nations have developed, we will reap the same kinds of rewards or problems that they have gotten. We have the best health care in the world, and yet we rank number 37. We have some of the worst situations in the world. The question is how do we get rid of the bad while maintaining the good.

CHAIRMAN PELLEGRINO: Thank you very much, Ben . I have Floyd Bloom , and then I have Rebecca Dresser , and I have Gil Meilaender. Bill , would you care to comment?

DR. HURLBUT: I'll wait.

DR. BLOOM: My comment is not should we take this issue up, but what we say about it and do we have the time to make an effective statement early enough in the terms of the next congress and president. And if our budget and our meeting cycle is such that we can't really do a bang-up job, I'd rather not take it up.

But my own tendency is that we should take it up and we should accelerate our schedule of participation in a way that we get our inputs to the writers and express the ethical concerns that you raise.

In my own mind I have difficulty separating the economic, social, and political aspects of what I see to be the problem. And I can't thank you enough for illuminating the ethical issues of the questions that lead me to the economic, social, and political issues. But what are we going to say, and is it enough just to confront the complexity.

I'm torn between the advice given to me as a medical student, which is — a medical student's tendency is when faced with a crisis to do something right away. And the resident who knows says, "Don't do something. Stand there and think about it."

And we've been thinking about this problem, as you say, for 100 years, and we haven't come up with an effective solution. So if we take it up — and I'm certainly in favor of taking it up — but I want us to be able to provide a product that would have some contribution to an ultimate downstream effective achievement of the goals as you enunciated them.

And so if we do it, I think we need to commit ourselves to participating much more effectively. You treat us very leisurely at this meeting. We have long lunch breaks and we have a long time between meetings, but I think this is potentially the most important thing we will take up. And therefore I would rather see us meet more often this year to get something out before the next president takes office.

CHAIRMAN PELLEGRINO: Thank you very much, Floyd . I think that is a very helpful comment and continuing along the way we hoped to go. In other words, we want to hear what you're saying. We'll get something back. And I couldn't agree more that the greatest damage we could do to any such inquiry would be to do it in a sloppy way or to do it from the point of view a polemical approach, or to do it from the point of view of self-righteousness.

Next I have Rebecca Dresser .

PROF . DRESSER: I think that what you've done so far in the staff's paper is very useful groundwork. The part 3 is the beginning of getting into the ethics. I think we could do two things. I think one we can do for sure. The other I'm not sure we can do, but maybe.

One thing is just to point out to interested people, some of whom are from the ethics community, the policy community, but some who are just people who want to understand more about this very serious problem — is the ethical questions and concepts that bear on this problem. And you've done that to some extent.

It seems to me after this meeting we're going to have some more speakers, some of whom will talk about a right to health care, one of whom will talk about having a religious basis to providing people in our community with health care, and perhaps trying to draw from us more about these are the ethical concepts and the ethical questions drawing from us. There could be a next step. So this part is more analysis — here's why this is relevant ethically and here is what is relevant ethically.

Then the second step would be and here's where we should go with it. And I can't say whether we can do that yet. I would want to see more about what is there in the first step. In terms of possible considerations to add that aren't in here yet — at least directly — there is this issue of is there a tradeoff that we have to make between innovation and equity, so that in order to have more equity, do we have to devote more resources to providing more people with adequate care and perhaps losing some in the innovation part.

I'm not sure whether that tradeoff is something that would have to occur, but it seems to me we need to talk about that and this whole issue of priorities and biomedical research, what kinds of research should have the highest priority, are there changes or revisions that need to be made there.

I have a recollection that Floyd , when you were president of AAAS made a really good speech on that — at least a speech I liked a lot about that. So that would be, I think, something to add.

Another is how the current system affects the quality of care even of well-off people. So this is mentioned a little bit about how it's so difficult to get an appointment right away. Another illustration is that even if you're well-off, on the weekends you're not well-off. So you have to go to the emergency room. And I just have heard so many stories about fifteen hours in the emergency room. Even — I never had it as a cancer patient, but other people I know with cancer who have spent that time.

And so it seems to me important to point out — I mean, one question is do we who are well-off — should we give so that others can have more benefit, which I think we should, but another is to point out how even we who are well-off are harmed by this situation.

And then a third point or concept to add is the effect that the current system is having on the morale of physicians and how fewer and fewer people are going into primary care because that seems to be the most difficult area of practice in our system.

And one ethical goal, it seems to me, should be to try to have a health care system where the physician/patient relationship, while not totally wonderful all the time, should be something that for both parties is sort of affirming and keeps the nature of it is — as sort of the beneficent basis that we always have though about medicine being. So that seems to me an important component to mention.

CHAIRMAN PELLEGRINO: Thank you very, very much, Rebecca . Next I have Gilbert Meilaender .

PROF. MEILAENDER: I don't know exactly what you envision the staff providing before September, but I hope we'll think about not ethics in a narrow sense, but in a sort of broader sense and some assumptions that work, because what you do with various kinds of ethical principles depends on a whole range of background beliefs that you carry along with you.

And this thought was triggered by what Ben said before, that the most important thing is life, which I think is clearly wrong, and I don't think Ben believes that for a moment himself, in fact. And at the very least there are some other goods we need think about — your freedom, your virtue, your honor, your attachments. None of these is more important than life?

Well, I think they may be on any number of occasions. So we need to — I mean, a fundamental question is exactly how important a good is life or health. And there are just assumptions at work in these discussions often about that that need examination.

So, you know , if we're going to press an ethical conversation, I think we need to get to those background beliefs somehow. We're not likely to agree entirely about them. They may be hard to really unpack in some ways, but I think if you don't do it, you're just spinning your wheels.

CHAIRMAN PELLEGRINO: I agree with you, Gil, and I also agree with Ben .

PROF. MEILAENDER: It's not possible to agree with both of us.

DR. CARSON: I just want to say that none of things that Gil mentioned are important if you're not alive.

PROF. MEILAENDER: And many of them are things that you're willing to die for.

CHAIRMAN PELLEGRINO: And what I would add to this is that laying out this difference, I would say, and defining what the implications might be in direction A or direction B is the kind of thing I'm thinking of.

Now, I guess I have a solid faith that if you lay them out, the right one will come up on this list. That's the one I think. I'm being facetious here now. I'm being facetious. I think laying them out is very, very important and there are important people on both sides of this issue.

DR. ROWLEY: Well, I just want to make a response to Gil, again saying that if the focus is going to be medical care and health, then some of the issues of honor, et cetera, are not directly involved. They certainly can be indirectly. But we have a different focus, I think, here in an ill child or a sick patient who can't afford adequate medical care in a society that is overall as rich as ours strikes at least some of us as being an immoral situation.

PROF . MEILAENDER: I understand that, of course, but a society that believes that nothing is more important than life will take a certain approach to health care, and it may be precisely that belief at work that has caused some of our problems, in fact.

CHAIRMAN PELLEGRINO: That empowers me to make just a little intercession. I think on this issue one of the things we would want to do, I would think, looking at the ethical issues is understand that there is some deeper metaphysical presupposition, pre-logical, if you will, in the reasoning which calls for a very different decision on what's ethically right or wrong.

But when I say it's an ethical question, I'm really asking for a definition of what the question is from an ethical perspective — that is, a formal, systematic, critical examination of rightness or wrongness of this particular act so that it would not resolve all the questions you've all raised, which are very practical questions, but at least provide public consciousness that it isn't all economics, politics, cost, value, et cetera. That's a major aim of my own.

I now find myself a participant in the discussion, and so I'll try not to abuse my chairmanship. Peter ?

PROF . LAWLER: I'm somewhat in sympathy with Gil that the — to me, the ethical issues aren't so obvious, partly because although Janet is right, if you focus on health care, then health care becomes the most important thing. If you focus on life, life becomes the most important thing.

But since we're giving advice to the American government, the American government can't focus on health care in isolation or life in isolation. So let's even say our job is — we have the ethical principle, the best possible health care for everyone. But then Rebecca said if we want to have an affirming patient/doctor relationship, well, that takes time. That's inefficient and that might produce inefficient health care from a purely engineering point of view.

And let's say we need to bring the Bible in as one of our readings, that our government should be based on an Old Testament covenant, and I like the Old Testament, one of the top two testaments and all that. But still all kinds of questions are vague. The Old Testament and the other testament even more so, are all about charity and so may be about the preferential option to the poor and helping the poor out and love. But because the testaments tend to be relatively indifferent to life as the most important thing, especially the newer one, then you end up having an indifference to the development of medical technology that allows us to make people live a very long time.

So the same people who are being charitable all day long, like the Apostles, aren't doing a lot of actual life-saving in a medical sense. So if we're guided by the Bible, there would be a lot of more charity, a lot more concern for the whole human being who is afflicted in so many different ways.

But if we were guided simply by the Bible we might put somewhat less emphasis on the unlimited development of medical technology and all these crises, like the crisis in the shortage of kidneys and so forth.

So if you think about it, I'm all for the Bible, but the Bible — the guidance the Bible gives us is sort of ambiguous because it's not about life at all costs, actually.

CHAIRMAN PELLEGRINO: Thank you. Paul ?

DR. MCHUGH: Well, I'm finding this conversation very helpful, and the ideas that we're trying to make clear to each other what is out there and what we are aiming at. Let me back up a little to tell you why I am still confused about the issues in front of us.

I'll put it to you this way that there are aspects of this issue in which we're using the word health care and we really mean illness treatment. Okay? That is, health care is so broad and health is such a universal thing I don't know where the limits might be in working that way.

And, in fact, at my institution I belong to two elements, one across the street from the other — the Public Health School and the medical school.

In the Public Health School, we're interested in working with populations and managing and helping populations. In the medical school we're interested in treating individuals who have a particular illness. Okay? And I wear hats on both sides, and occasionally I get confused about it, but I understand what I'm doing, especially with the government when I'm across the street in the Public Health school.

In public health I believe that we're trying to protect, as well as treat a population. So we work on things like the water system of the city. We work on the issues of immunization. And then we work on certain populations that we believe have illnesses that render them helpless and in need of care, particularly, of course, that includes the mentally ill.

And then when I look at, okay, well, how well has the government done and picked up on the issues of the mentally ill. We have a very checkered record. We began in the 19th century totally committed with such wonderful people as Dorothea Dix who probably did the first social science piece of work in our history, American history, demonstrating that the mentally ill, vulnerable and violent, were all in jails and in other shelters and not getting the care they needed.

And we as a country moved forward and said, "We're going to take care of them." We got overcrowded. In the 1960's we had what I call an unholy alliance between the conservatives who wanted to save money in the mental hospitals and everybody else was worried that maybe the freedom of those poor people were being afflicted, and so we turned them all loose into the streets.

And what did they do, they went into the back alleys and they suffered terribly. And, of course, as well they caused terrible trouble. The Virgina Tech episode was due to the fact that we couldn't figure out as a government what to do with a seriously mentally ill person who was quite dangerous and everybody knew he was dangerous.

So on the other side of the street, there's no question that I'm working with individuals, and just as Ben says, we're not going to turn anybody away who's sick. So whatever kinds of policies that we're going to do and talk about as an ethical group, I would like us to be able to say, perhaps, that we're relating ourselves particularly to illnesses, from the illnesses that the people everybody could agree are helpless and hopeless in their care and needs to have an agency of government and perhaps other eleemosynary groups to help them and care for them down to illnesses in which in we'll expect not only can there be help for the poor, but also for the less poor, that they will collaborate with the services to maintain the hospitals, to maintain the services and the equipment that Ben needs to do his wonderful, wonderful surgery.

I would feel better about the ethical postures that we were taking if we were talking less about health care and more about illness care and defining which illnesses we mean when we call for the resources of the government and the resources of families to provide them.

CHAIRMAN PELLEGRINO: Thank you very much, Paul . I think you might recall that in my quick going over I said one of the questions was to distinguish medical care and health care. One is a rescue.

DR. MCHUGH: I do remember that. I just wanted to speak to my condition.

CHAIRMAN PELLEGRINO: Oh, you just wanted to elaborate, and you did very well, but I just wanted to know, I do agree with that separation. And the point I was leading up to, however, though, is many ethical issues are conflicts of obligations. We may start from believing that we have obligations to both, but when conflicts of obligations occur, we need some priority principle that will enable us to choose in which direction to go. And so, again, I think that's a formal part of an ethical analysis that I would see very, very appropriate, as you pointed out.

Carl and then Ben .

DR. SCHNEIDER: It strikes me as possible that the conversation illustrates the black hole. And one way that might make it possible to stay away from the gravitational force or whatever it is of the black hole would be to ask where we are in the United States today and what the public issue is.

And the public issue, I think, is the question of the great difficulty that a large number of people have in getting basic medical care. That's the question that we've been working on and arguing about for 100 years.

And as I recall, Harry Truman tried it the year that I was born many decades ago, and I think the more that we try to fully elaborate all of the principles that might be involved in thinking about restructuring health care, the more hopeless and black hole-ish things get.

It strikes me as possible that one might say whatever else you do, there is an urgent need to deal with the particular problem of people who simply can't afford even quite basic health care or are given it in such a difficult way that effectively they can't afford it.

It strikes me as possible there might be some even consensus on the social, moral, ethical duty to provide that kind of care. The reality then is that what's going to happen is that the question will be decided by another one of these huge political conflicts in which people with all kinds of beliefs and interests are going to negotiate.

And at that point everybody is going to have to give up valuable things, and I think it stops being possible to say this is really the morally preferable way and the real issue becomes not what would the optimum moral way be, but is there any way that we can convince people that the ethical duty to provide this kind of care is so urgent that you ought to be willing to compromise to find something.

CHAIRMAN PELLEGRINO: That states the issues very, very well and very clearly. You ask the question, you have a moral obligation, now we get to the practical question, how best to bring it about and what are the limitations and what are the problems.

DR. SCHNEIDER: Those are the questions I would avoid. It's just stating a single important principle.

CHAIRMAN PELLEGRINO: Ben .

DR. CARSON: I want to clarify what I was talking about and the basis of it. When I first came to Johns Hopkins decades ago, I was very impressed by some of the types of patients that I saw there — the crown prince of this country and the CEO of this company and the president of this organization, people of enormous accomplishment, people who had written volumes on great intellectual subjects, dying of glioblastomas.

And every single one of them would gladly have given every title and every dollar for a clean bill of health. That's what I'm talking about when I'm talking about, you know, what really becomes important at certain points in time.

And a lot of the things that we talk about are aimed at giving people a clean bill of health or helping them to maintain a clean bill of health, and, therefore, if you can talk about the things that are aimed at a goal, then why not talk about the goal itself.

And how can we provide good health care for everybody, I think is, in fact, a significant moral and ethical issue. We spend more per capita for health care than any other nation in the world and yet we rank significantly down the list in health care. It means that there are some huge problems in the system.

Is it our job to address those and to fix them? No. But I think we could provide some service by pointing out some of the things that are preventing us from being able to reach at least the level of many other industrialized nations in terms of health care distribution when we pay so much more than they do in order to achieve it.

CHAIRMAN PELLEGRINO: Thank you very much, Ben . Right on the point. Anyone else, or have we exhausted the question? Thank you. Peter .

PROF . LAWLER: Dan and Carl sum up the remarks. They didn't get way metaphysical on us. They just took as a given in the spirit of geometry that every American should have access to basic health care, not even exactly as a universal and deep right, but we're spending all this money, we have all this technology, and we should be able to do this. And at that level there is in the country a broad consensus. Both presidential candidates are in favor of doing that. Their plans aren't as different as it first seems and so forth.

And so Carl's criticism amounts to a lack of intensity, that we don't regard this as important enough to just sit down, compromise, try to do as Ben says, to get this done while keeping what is good about our present system. So we need to sit down and get this thing done while preserving as much as we can that is good about our present system.

So there is a consensus in the country, I think, in the need to do it. The country has not gotten together and put down a metaphysical foundation. As a philosopher I hate says, [there is a] kind of “overlapping consensus,” and while this is a good thing to do, and I don't think anyone in this room or any room in Chicago would deny that in some sense we need to get this done.

And the fact that we don't get this done is about — because our present system is a monstrous series of accidents based upon things that are no longer relevant, like employer-based health care and so forth — employer-based insurance and so forth.

So if there's a crisis, it would not be a crisis in metaphysics. It wouldn't be a crisis in resources. It would almost be a crisis in intensity. We don't regard this as urgent enough to get it done fast.

CHAIRMAN PELLEGRINO: Bill , I think I saw an expression that suggested you wanted to speak.

PROF . MEILAENDER: Well, I just don't believe that, Peter . We have all sorts of smart people who themselves, at least, certainly think it's extremely important, thinking about it and working on it, and unable to agree about how to accomplish it. So it just seems to me that, prima facie, it's a little more complicated than that.

PROF . LAWLER: I think there is a rough agreement on the goal, but there is considerable disagreement on need. And one reason there's a disagreement on need is the fact that we don't have facts straight.

PROF . MEILAENDER: There are many goals. And we regard them all as important and what we haven't got the foggiest idea is how to go about trying to achieve them simultaneously.

PROF . LAWLER: But there is an agreement that we shouldn't have a large number of people who are uninsured or incapable of getting insurance and we need to move away from that in some sense. There is massive disagreement on how to do that and what method is — most of these things are prudential matters, actually: How will we achieve this in the best possible way? But if you look at the program of McCain and the program of Obama, the goal is not so different. How to achieve the goal is somewhat different.

PROF . MEILAENDER: But we could achieve that goal overnight if we didn't give any high-tech treatment to people over 70. And there are all sorts of things you could do if you really wanted to accomplish it.

PROF . LAWLER: Yeah, but that's not the goal I'm really talking about. Actually the goal I'm talking about is having everyone have access to insurance, either — and the method most likely [to achieve that] is to … detach insurance from employment, have people buy it who can afford it and have subsidies — tax breaks and subsidies for people who can't afford it.

DR. SCHNEIDER: The political reality of these debates has been that you have groups with interests that have been very insistent on prevailing. Organized medicine has had an extraordinarily powerful effect. Insurance companies have been effective. And people can be convinced — ordinary citizens can be convinced that their interests are very directly at stake.

And so I think Peter is right. The problem is we're asking people to give up things that they want to have and to compromise their own direct personal and economic interests. And we have a system which makes it possible for lots of groups to veto change, certainly in combination. And so I think the intensity of the moral duty is a point worth establishing.

CHAIRMAN PELLEGRINO: I think all of these practical difficulties you're laying out are without doubt part of the discussion. But I suppose whatever comes out of an attempt to describe the ethical issues, if one can raise them in a non-offensive but appealing manner, one really hopes — and I know you practical minded people around the table are going to say the chairman's idiocy is now reconfirmed — but I do think that a well presented moral position does move people.

Now, I'm not a preacher, and I don't have the powers necessary, but I do think and have more faith, I guess, in the American public's capacity to grasp what it means to do some of the things we're doing and go to one of the questions I raised, what it reflects on the kind of nation we are in the way we treat the under-served, those on the margins of society, the very young, the very poor, the very ill. We're not doing a good job of that.

PROF . MEILAENDER: Well, just one more word on behalf of the metaphysics of this. All these people who we're asking to ratchet up their intensity about this problem and understand that we must all give up some things in order to achieve this agreed-upon goal are people who we also seem to think are committed to the principle that they want to live as well as they can for as long as they can. And as long as that fundamental good is at work in the background, you're going to have a very hard goal of persuading us to make these sacrifices when push comes to shove.

CHAIRMAN PELLEGRINO: I think that's a reality, Gil. There's no doubt about it. And I just would like to see a balanced point of view on the other side of it.

PROF . LAWLER: I actually don't completely agree with that in a sense. It is a question whether our country from a political point of view can deviate from the principle that people can live as long as they can and that public policy that actually supports that demand. I would be in favor of a public policy that does limit talk about rights. Rights reside with the individual.

DR. SCHNEIDER: Could I just raise one question that might be —

CHAIRMAN PELLEGRINO: You may.

DR. SCHNEIDER: If the staff has a relatively available way of answering it. How many other countries have managed to reach some accommodation of this problem? How did they do that? How central was metaphysical reasoning in their doing so?

CHAIRMAN PELLEGRINO: There's a question I think the sociologists could answer and the historians better than I could, but I think that an approach to this in a pluralistic society, in a democracy, will mean agreement upon what is an action that we all accept without necessarily sharing the same metaphysical theological foundations.

And the one example that I use about that is the U.N. agreement on the dignity of the human person, the equality of the dignity of every human person, which was based, as you know, on a response to the horrific experience of the holocaust and associated activities. They came together, 30, 40 nations, and signed it.

I think I've mentioned to you that I've been on the International Bioethical Committee of UNESCO where we issued a declaration which again said the first principle of bioethics was the dignity of the human person, which had to be protected, even in the light of human experimentation, et cetera, et cetera, et cetera. I assure you, having been there, the metaphysical din was a very, very highly impressive one. But nonetheless, they agreed on the principle.

I think in this nation we could. Now, I don't know how many of those there would be, how many it would be possible to do, but unless we give the definition, we can't begin to say how about this. And I'd like to quote — and I did in my paper in the Dignity volume — John Keats , who says that you have to feel these things on your pulses.

The poets are the antennae of the race, in my opinion, and I think Keats caught the notion that an axiom wasn't an axiom until you really felt it on your pulses. And I think maybe the reason Ben and I and doctors take the position we see it in the city of Washington . I've lived there 35 years — a neglected population of people who are not — we're not talking about advancement of their health to the state of enhancement. We're talking about daily needs that are unmet and can't be met because they can't pay for it, can't have access to a doctor. What does that mean to the American people about the kind of people we are? That's the question I'm asking.

DR. MCHUGH: I just want to come back in for the defense of the aged. I've been doing this for a long time on this Council, especially whenever we have Daniel Callahan come back and tell us and remind us of how should be watching it.

Medicare was put into place primarily because we began to realize that the people that were the most likely to suffer from neglect and from not having the support that they needed were the elderly. And I'm not here to speak for a system that would begin its rationing by cutting out people my age and older, for one thing.

But then, again, it brings me back to what I was saying before. This is the problem with talking about what amounts to a public health system. As soon as you start thinking in terms of publi