Meeting Transcript
September 6, 2007

Council MEMBERS PRESENT

Edmund Pellegrino, M.D., Chairman
Georgetown University

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

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

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

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

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

Alfonso Gómez-Lobo, Dr.phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

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

Peter A. Lawler, Ph.D.
Berry College

Gilbert C. Meilaender, Ph.D.
Valparaiso University

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

Diana J. Schaub, Ph.D.
Loyola College

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

INDEX

• Session 1: The Draft White Paper on the Determination of Death
  
• Session 2: The "Crisis" in the Ethics and Profession of Medicine: A Historical Perspective
  
• Session 3: The "Crisis" in the Ethics and Profession of Medicine: The Perspective of Medical Education
  
• Session 4: The "Crisis" in the Ethics and Profession of Medicine: Some Concluding Reflections
  

   

SESSION 1: The Draft White Paper on the Determination of Death

CHAIRMAN PELLEGRINO:  Good morning.  Good morning.  Welcome to the meeting of the President's Council . 

The first act in these meetings always is for the chairman to recognize the presence of the official government representative who sits to my left, Dr. Daniel Davis, who is the Executive Director of the Council .  Dan, we acknowledge your presence and are delighted to have you as always.  Dan is the man who does all the work on the Council .  You must know that.  It's not just a title that he carries.

I would like to begin this Council meeting by expressing on my behalf and on behalf of the members of the Council our gratitude to Dr. Leon Kass who has completed his current course of appointment and has asked to resign from the Council .

It's my great pleasure to personally enter into the record, I hope adequately, the gratitude of the members of this Council to Leon, who really is the founder of the Council , the first chairman, its inspiration, and a person who has set a very high standard for the work of the Council and whom I've had the pleasure of knowing as a colleague for many, many years.  Leon, we thank you most sincerely. 

Leon is serving on the Council beyond his previous termination of term at my request, and I had hoped that he would continue.  But his own personal preference is now to direct his attention to many, many of the other things which he's doing.  We understand that. 

But he has promised me to be available to us.  And those of you who know him, know him as a source of wisdom that we did not want to lose any contact with, both personally and also, of course, officially as the Chairman of the Council .

So, Leon, thank you most sincerely.  And if I can break precedent, I'd like to.

(Applause.)

This is one time, Leon, you don't have to respond.  I'm sure Leon suspects, "Oh, there he goes," and he doesn't want us to say too much -  not the case.

Our agenda this morning, or today rather, covers the following two topics:  The determination of death, which has come to be a very actively discussed issue now that had been closed for many years or assumed to be closed; and then the latter part of the day some discussions of the status and the question of professionalism in medicine and the other health professions and, to a more distant degree, those other professions outside of the health field.  Tomorrow, we will look once again and be brought up-to-date on the status of nanotechnology and the ethics associated with it.

I would like to begin the first presentation.  Diana Schaub, a member of the Council , who will initiate an open discussion, has kindly consented to do so on the staff paper prepared by Alan Rubenstein.  Dr. Schaub?

PROF. SCHAUB:  As some of you know, I'm a fan of the original Star Trek series, and I remain unabashedly a fan despite the teasing that such a declaration can bring. 

The best known line from Star Trek must be "Beam me up, Scotty," but a close second would be "He's dead, Jim."  In episode after episode, Dr. McCoy arrives to examine a prone crew member.  He waves a wand-like instrument over him, then looks at Captain Kirk, and says "He's dead, Jim."

I think that's how we want the determination of death to go.  We don't want folks to die, but if they're going to, we want a clear pronouncement. Not "Well, he's dead by Criteria Set 4, but still alive by Criteria Set 2." 

Now we are never told what precisely Dr. McCoy's tricorder registers, but perhaps it takes the measure of the three body systems that this report focuses on:  The heart and circulatory system; the lungs and respiratory system; and the central nervous system, and, in particular, the centers involved in breathing. 

The fact that he uses a medical device of some kind does suggest that his verdict, while stated apodictically may, in fact, be based on evidence that is harder to discern and more ambiguous.

We've long known that there can be ambiguity surrounding death.  There can be illnesses and conditions that mimic death.  Think of all those folks unfortunately buried alive in the stories of Edgar Allen Poe.  There are also drugs and potions that can deliberately mimic death.  Think of the friar's description in Romeo and Juliet:

  Take thou this vial, being then in bed,

  And this distilling liquor drink thou off;

  When presently through all thy veins shall

              run

  A cold and drowsy humor; for no pulse

  Shall keep his native progress, but

              surcease;

  No warmth, no breath, shall testify thou

    livest;

  The roses in thy lips and cheeks shall fade

  To wanny ashes, thy eyes' windows fall

  Like death when he shuts up the day of life;

  Each part, deprived of supple government,

  Shall, stiff and stark and cold, appear like

              death;

  And in this borrowed likeness of shrunk

              death

  Thou shalt continue two-and-forty hours,

  And then awake as from a pleasant sleep.

Interestingly, Shakespeare mentions three tests:  the pulse, the breath, and the "eyes' windows."  The three seem to roughly match our existing standards for a determination of death: the cessation of circulatory function, the cessation of respiratory function, and total brain dysfunction. 

I suppose it would be too much to ask doctors to use Shakespeare's more mellifluous language, but it is a remarkably clear set of bedside tests:  "no pulse shall keep his native progress," "no warmth, no breath shall testify thou livest," and, last, the "eyes' windows fall."

In the past, it seems that what was likely to be obscured and hidden from view was the presence of life.  We could be fooled by the outward appearance of death and overhasty in consigning the living to the places of the dead.

With the advent of life-prolonging technologies, particularly the mechanical ventilator, there is a new twist on the old ambiguities and mistakes.  A device meant to save life may, we are told in certain situations, only mimic or simulate life.  We have been assured that death may, in fact, occur, despite some of the signs and likenesses of life continuing as a result of medical artifice.  So what is obscured and hidden from view now is the presence of death.

That itself is progress.  It's surely better for death to be disguised or unperceived because of the work of a ventilator than for life to be disguised or missed because of a mistaken judgment.  Not nearly as much harm is done when we err on the side of life.

This report, "Controversies in the Determination of Death," does a fine job of setting forth the evolution of thinking about the standards for determining death.  It traces the emergence of an alternative neurological standard of death in the 1970s to supplement the traditional cardiopulmonary standard and examines the continuing challenges to that standard.

It turns out there are some overlaps between our work on this issue and our work on organ transplantation.  There is a hint that transplant politics may have played a role in the pressure to formulate and adopt the neurological standard of death, just as it is playing a role now in the pressure to make certain alterations in the neurological standard, moving from a strict whole  brain focus to a looser consciousness-related formulation.

While I find this linkage disturbing - and I confess it makes me inclined to be a bit suspicious of the neurological standard - I also believe that it's best to assume good will on all sides in scientific, intellectual, and even political debate.

Even if the neurological standard was in part motivated by a desire to create the heart-beating dead-donor category, the question still remains:  Is the category a true one?  Are there heart-beating cadavers and ventilated corpses such that we need a neurological basis for the determination of death?

Admirably, the report takes up this question in Chapter 4, first laying out the reasons for doubt that were posed originally by Hans Jonas and elaborated and updated more recently by Shewmon and then, most ambitiously, attempting to answer those doubts and defend the neurological standard with a new and better biologically-based rationale.

The debate concerns the meaning of wholeness.  Instead of looking internally at the presence or loss of somatic integration, the report suggests that we look at the organism's relation to the external world.  A living organism is in need of and open to commerce and exchange with its environment.  Spontaneous breathing is a crucial manifestation of such openness. 

The report even states that this "commerce with the surrounding world" is "the definitive 'work' of an organism."  When the drive for such commerce is irreversibly gone, as in total brain dysfunction, then the individual is dead.

I don't know quite what to make of this argument.  To a political scientist, used to thinking more about the body politic than the individual body, it's certainly intriguing.  According to Aristotle, the wholeness of a body politic is a matter of internal structure, integrated functioning, and purpose.  It's more about domestic politics than about foreign relations or commerce with the world.

This difference in self-sufficiency between bodies politic and individual bodies may just be a sign that the analogy is flawed and that bodies politic are not living organisms.  Still, it seems to me odd to say that the wholeness of a living  organism hinges on its needy openness.  Apparently the wholeness of organic life is not whole in the sense of complete or unified.

But even granting that organisms have a needy, outward-directed mode of being, is it correct to say that satisfying this need is the definitive work of an organism?  Isn't it just a precondition of the real work?  If that precondition is met by artificial means, like a ventilator, some at least of that internal work of the organism continues.  Would the fact that the body uses the supplied oxygen be an indication that the drive for breath is present internally, even if it's not capable of independent external operation? 

Most astonishing, I thought, were the cases of pregnant women diagnosed with total brain dysfunction whose bodies continued to provide support to the developing fetus for days and even months.

My uncertainty about the line between life and death would, I think, have inclined me to resist the neurological standard back in the 1970s.  However, that same uncertainty leaves me inclined today to accept the settled, majority view of the medical profession. 

Nonetheless, the debate seems to me salutary.  Openness to new evidence and arguments is as much a part of the scientific enterprise as spontaneous breathing is to the living organism.

CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Schaub, for opening up the discussion leading us into a number of serious issues and questions.  I really appreciate it and thank you.

Dr. Schaub's comments and the staff paper itself are now open to discussion by members of the Council .  Does anyone wish to - Dr. Bloom?

DR. BLOOM:  I sent these comments to Alan.  It seems to me that there are three general points.

This draft is much better to me than was the original, but I think we go still too far overboard in paying attention to the objections of Shewmon over and over and over again.  It seems to me that confronting his issues and then rebutting them is sufficient.  But we go through it in almost every chapter, and it seems to me to give more credence than that set of views demands.

Secondly, I think we still go too far overboard in muddying the distinction between why we're doing this and the issue of organ allocation.  Once we've said in the beginning that we're not doing this for organ allocation but we're doing it to define a standard by which futile treatment of irreversible damage is no longer possible, that seems to me to be a much more sufficient and clean medical distinction as an end point, rather than to keep bringing up the consequences of this for organ allocation.  That's being dealt with in another report that we're doing.

And then there was one rather egregious error in terms of where the antidiuretic hormone is released that needs to be taken care of. 

But those are my three general comments.  I had a lot of little nitpicking comments.  But those are my two general conclusions and the error.

CHAIRMAN PELLEGRINO:  Thank you very much.  Thank you very much, Dr. Bloom.  That's precisely what we would like to hear, the careful analysis of this particular presentation.

Let me say that we'll be asking all of you at the end of this discussion over the next several weeks to provide us with further comments in writing and, as has been the custom of the Council from the beginning, Council members may present their own opinion of the matter, and I appreciate very much the careful thought you've given to it, and we'll certainly correct that matter of the antidiuretic hormone.  Several of us missed that.

Dr. Alfonso Gómez-Lobo?

PROF. GÓMEZ-LOBO:  Thank you.  I wanted to take up one of the points raised by Floyd just from my own perspective.

I think the reason to go back to Shewmon's position is that, if Shewmon is correct, it's really a major challenge to the idea that whole brain dysfunction is an adequate criterion for death.  I mean, if it's true from his meta-study that there are all of these functions that continue to be discharged by the body - I'm looking at Page 36, for instance - such that he can talk about chronic whole brain death, then, of course, that is where the main challenge is at present it seems to me. 

I mean, if, indeed, the rationale for the Harvard Commission is not correct - in other words, if it is simply not true that the brain discharges the function of providing for the integration of the body such that there is a number of functions, integrated functions, that continue after that happens - it is a major problem.

I must confess, being an outsider of these matters, that I'm perplexed.  I would like to see the arguments really set out on both sides.  I would even go as far as wanting to have Dr. Shewmon testify.  I mean, I really want to see what's the depth of his thinking on these matters.

Now if you think that the evidence is inadequate, that Shewmon's position can be dismissed because, say, there's a misdiagnosis of the case of whole brain death, that's another possibility.  But I would have to see the evidence for that.  Thank you.

CHAIRMAN PELLEGRINO:  Thank you. 

DR. BLOOM:  Well, I'm sure others will contribute to this discussion.  But my comment in the margin of Page 36 is that none of these equal a living person.  And I have no idea who Shewmon is and from what basis of experience and knowledge he draws his opinions, but I find them fallacious.

DR. FOSTER:  Could I just say also that I don't know what the evidence is for, I mean, real evidence on any of these things like that the immune system is still working and fighting off infections.  That seems to be a bizarre claim to me.  I mean, what is the evidence for that?  I mean, there's not evidence at all.

And amongst the other things, by the way, Renin is misspelled in that chapter.  It's R-E-N-I-N for whoever is doing that, so.

Anyway, so I agree with Floyd about that.  There are these enormous claims.  And meta-analyses do not really answer anything, I don't think.  But to make these, I said the same thing.  All these claims that a brain-dead person can do, like an intact immune system, I don't know where that comes from.

PROF. GEORGE:  Just so I can be clear, Floyd, are you and Dan disagreeing on the question of whether these are good indicators of death or life, or are you disagreeing because Dan doesn't think that what we would ordinarily call a brain-dead person is actually capable of manifesting these factors set out on Page 36?

DR. BLOOM:  Well, my take is that, even if they were true, they wouldn't be life.  Now, Dan is questioning whether they're even true.  But even if they were true -

PROF. GEORGE:  Dan, from your point of view, if they were true, would that manifest the existence of organismic wholeness or integration so that we would have a life?

DR. FOSTER:  No.  I would not.  I agree with Floyd about that.  I don't, and I want to make it clear.  I have not made a systematic study of this.  You know, if you're going to ask a question, a scientific question, about the immune system or something, I have not studied all of the data.  I've just looked at what he has said.

So, yeah, I don't think a part of something is life.  Look, if I take a liver out of an animal, which I've done about a hundred thousand times, you know, and profuse it, it will do everything single thing that a liver in vivo does and in which you discover all sorts of things.  It's working.  We've done it for very long periods of time.

It would be a little unusual to me to say that  the fact that this liver is working is some sign that there's life in the animal from which it came.  That's a silly statement because the animal has obviously been euthanized.  But the point is that the fact that an organ can be kept alive or stays alive for a period does not mean that there is any continued possibility of life.

If this was an argument that, if you stopped the respirator, somebody would start breathing again and would do that if that was possible, then you might have an argument I think.

The fact that something works for a while after that, I mean, these things work all the time.  We take out hearts, and, you know, we fly them across the country and so forth, and it will still work, I mean, to do that.

So, yeah, my point is two, Robby.  I mean, this is not a big thing to me, this whole issue that we're talking about here.  I mean, dead is dead.  I mean, I don't know how many times I've declared it, just what the initial comments were.

But my points are two.  I'm suspicious of the evidence that's had such an emphasis in this paper because I don't know where that came from.  And as a physician scientist, it looks very doubtful to me, the claims that he has said here.  The second thing is, to me it doesn't alter the argument that the person is still alive just because, let's say, the nails grow or something like that.

PROF. GEORGE:  Dan, if you removed a heart or a liver from an animal, would it be possible that that part, that organ, could fight infections or maintain body temperature?  These are what the claims -

DR. FOSTER:  That's not really something that a liver or a heart does anyway, you know, I mean, that does that. 

But I'm also very suspicious.  I mean, I think he says that the body temperature drops.  You know, it's not maintained at a normal fashion.  With blankets, yeah, I mean.

CHAIRMAN PELLEGRINO:  Dr. Kass?

DR. KASS:  Thank you.  Let me make a couple of general comments.  I also agree with Floyd that this is a much better draft, and I've provided both the micrographic comments and also a slightly longer comment which I think would help beef up the argument defending the use of the neurological standard.  I sent it too late by e-mail, and there are copies here for you to look at as you wish.

And I also think perhaps we've made too much of Shewmon.  But the fact that the question has arisen and that there are still a lot of people who talk as if there's brain death and then there's death indeed, it's probably useful to try to clarify this in the way in which this report is done.  And I think this is a very valuable contribution, and I'm very happy to see its evolution to its current form.

Second, the Harvard criteria report, notwithstanding the mixed motives, I think, did a very fine job in laying out the criteria for determining whether you still have a living human being in the presence of a ventilator which might, in fact, mask the truth of the matter.

They were very careful not to elaborate any concept of death or give even some kind of theoretical justification.  It's a set of operative tests, and those tests more or less continue as we have them.

The trouble started when people tried to articulate the justification for this in terms of some understanding of why the complete dysfunction of the entire brain constitutes the equivalence of the death of the organism as a whole.  And in that paper by Bernat, et al., the concept of integration took very great prominence.  And it seems to me it is that which Shewmon is after when he raises at least some of these objections. 

And, I mean, I would share, I think, Dan's desire for more evidence on many of these points.  But I would be inclined to think that certain things, at least in some cases, have been noted.

But those kinds of somatic integration don't, it seems to me, add up to the existence of the living organism doing the work of the organism as a whole. 

So here I think,this is Floyd's point, and you also agreed with it.  I would grant Shewmon all of these things and say "very interesting."  But even in the presence of those things, one could still say that the organism as a whole is no longer with us.

And here, just a small comment to Diana's very elegant opening.  I think the emphasis on commerce with the environment does make it look as if foreign relations are of the essence, and this comes out, I think, in my suggestions for redrafting it.

I think what Alan wrote and is really very nicely hit on is, let's not talk about integration.  Let's talk about the work, the essential work, of the organism.  The essential work is its capacity to maintain itself, and that activity of self-maintenance requires, on the one hand, an inner drive to do so, the ability to act on the environment at least minimally to provide that without which there could be no organic life, and some kind of responsiveness to the world, at least minimal responsiveness.

And it turns out that he's given a kind of intellectual justification for using these criteria that the Brits use, which is to say, no awareness and no breathing.  If you can't do that, you can't do.  That's the ground.  That's not the highest thing that an organism does.  That's not the reason that all of us want to stay alive.

But absent that foundation, there isn't anything.  So I think this report stands a chance of rescuing the criteria giving it a sounder, not foolproof, but a sounder philosophical defense in which Shewmon's objections can be acknowledged and bypassed.  And I think this is a real contribution and would give lots of people much greater comfort that the doctors who proceed primarily without these philosophical reflections are doing the right thing.

CHAIRMAN PELLEGRINO:  Thank you.  I have Dr. Meilaender and then Dr. Dresser.

PROF. MEILAENDER:  I want to make one comment about Floyd's second point and then a comment about the most important issue that's arisen.

Your point, your second point, Floyd, was something like there was too much emphasis at the start on the organ-transplantation allocation issue, and the alternative that you suggested was, sort of, when treatment is futile.

To me, that doesn't quite get it right because the issue is, the real question is, it's not just organ allocation.  I agree with you on that point.  The question is when you have a corpse.   And if you have a corpse, it's not that certain treatments are futile.  It's that the very concept of treatment ceases to be relevant any longer.  And so I just wanted to sort of clarify that in a way.

Now to this other issue.  I mean, I can't evaluate Dan's and Floyd's objections to Shewmon's thing.  I've taken it seriously just because people in the bioethics world seem to have taken it seriously.  I have no better reason than that, I suppose, for doing so.

But it has been taken as a serious challenge to the use of the concept of integration as sort of the mark that we're looking for to distinguish between a living and dead being. 

I mean, I think it's true.  Dan's illustration of the liver is nice.  The alternative that's being developed here is that it's not just that the body continues to be able to integrate certain functions of one sort or another, but that the living being is still present. 

And the attempt to provide a different account of that here, I think, is a really potentially excellent contribution.  At least it seems to me that.  I mean, it's not clear that the integration concept in and of itself works. 

We've got something else going here, what Leon just summarized a moment ago.  And I find it both interesting and potentially significant as an alternative explanation of why total brain dysfunction seems to us to be so significant.

I actually think also - but this sort of goes beyond what we need for this report - that it's a philosophically fascinating alternative that's being offered, what Leon just characterized as the organism's capacity to maintain itself shown in both an inner drive and an openness to the world.

I mean, there's something quite interesting in the fact that maintaining oneself requires an openness to the world.  I mean, I think actually the implications of that are much larger than just a question about transplantation. 

So I think we have a potentially really significant contribution here saying something that hasn't - it's not that nobody has said it before.  But it hasn't played the important role in these discussions that it could, and I think it's a very useful thing to put forward.

CHAIRMAN PELLEGRINO:  Dr. Dresser and Dr. Hurlbut.

PROF. DRESSER:  I, too, think that the report is much improved, much more accessible and clear to educated lay people, and I really congratulate you on that.

A couple of specific things.  On this list by Shewmon on 36, I know from the movies, I think, that when people die in the ordinary way their hair grows and their nails grow, and I was wondering if there are other things that apply to people declared dead by the cardiac standard that could be cited as examples of things that continue to go on but we still consider them dead, to respond in part to him.

The second thing I wondered about was on Page 10 where there is a discussion of acknowledging  whole brain death, we can't really know that those people are dead.  But organ transplantation is a benefit to society that we want to maintain even if we cannot know that the donors are dead.

The main proponents of the view that we should abolish the dead donor rule in my reading are the ones who want to say more like, "Well, maybe the people with whole brain death are dead.  But there are other people who don't meet that standard.  There are severely brain-injured who are close enough that we should be able to take their organs."

So the way this was presented struck me as a different framing of that argument.  Later on, the other one is presented.  So I just wondered if whether that was something that would be confusing or kind of throw people off.  So that would be something to think about.

And then the third thing was in the donation by cardiac death toward the end.  I thought that part was a little bit too truncated.  For example, on 47, it's discussing this irreversibility question and mentions at the end that traditionally physicians don't rush to declare death, and it's kind of a notion of recognizing the dignity and the mystery and the dying process not to run to somebody's bedside and say, "Okay.  They're dead."  And I thought that was good material.

But then I wondered, "Okay, well, what is the point?"  The next paragraph just kind of says, well, this is something society needs to think about.  And I just wondered if we could do a better job of drawing some conclusions or sort of just finishing off that part in a more eloquent way. 

But other than that, I thought it was very, very well done.

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

DR. HURLBUT:  So I want to get back to what Floyd started and try and engage Floyd and Leon in this dialogue because I think there might be something really substantive there, and Dan, too, here.

First of all, I know Alan Shewmon personally.  I've talked with him about these matters.  He's a neurologist on the faculty at UCLA, at least he was when I talked with him.  I haven't talked with him in three or four years, maybe a little longer.

And I think what he's doing here is something that is, indeed, thoughtful and challenging to us and important for us to consider.  He's a very thoughtful person and a very earnest person.

And I think we should take seriously what he's saying, that if we're going to fairly superficially define life and death by some notion of somatic integration, then we have to take seriously that, as he says, the functions of the body that one would say define integration are, in fact, whole body properties, that they are emergent properties of the whole, and that they reflect the well-working whole and they reflect what the organism as a single unit does.

So then the question becomes, well, if there are systems - and Dan may be right.  He may be exaggerating these.  But if you look at what he's saying, he says there are these troubling evidences on the edges of this.  This meta-analysis may or may not be right, but there are enough troubling issues here.

He points out that certain body functions do seem to involve more than what you might call a part.  They involve numerous parts of the body acting together.  And so then the question becomes, well, now are these really what you would call somatic integration in the fullest sense or are they just subsystems?

And there's where I think we might have traction on what Floyd is talking about, that, in fact, just as the body has parts, it also has distributed subsystem functions that don't rise to the level of what we could reasonably call the action of the organism as an integrated unity.  And that's where I think we might get some traction, and I'd like to ask you to further explicate that.

But just a couple of more comments before you do that.  I think what Alan is worrying about is, we all know now that DNA essentialism isn't a very good picture for how genetics works.  It puts the emphasis too much on the DNA, which, in fact, is just a component of a larger system.

I think what he's getting at is, we have to be careful of not establishing what we might call neural essentialism to say that the person is the neurons operating in a certain way.

But what I would like to suggest is that, while there may be subsystems of the body, these subsystems are, in fact, joined and become integrated when the brain is operating.  And when it isn't operating, they are fragmentary subsystems, and you can go on with that.

But I'd also like to put a question to Leon and that is, what do we really mean by integrated unity for an organism and might not this integrated unity differ in the kinds of organisms we're talking about?  And I'm thinking specifically here about parasites.

To me a crucial term in all this might be the self-subsistence that characterizes an organism, and, yet, there are differing degrees of passive and active natural existence for organisms.  And here the ventilator almost feels like the relationship between a host and a parasite where something is supplied that other organisms supply for themselves.

So the question then becomes, do we need to define human wholeness, human integration, by somewhat different criteria than we might for other organisms?  And that brings us back to the special types of active agency that human beings have. 

And so I would specifically like to ask you to articulate, Floyd, what you would find inadequate about Alan Shewmon's ideas and what you would define as the integrated unity of the organism, and to ask Leon, specifically, what he might say about the species-typical dimensions of commerce and whether there might be something specific to human beings that we might focus on?

And, finally, I do want to get back to this one or at least mention it, if it's appropriate now, and that is, beginning on Page 6 in our report we use this word "health" I think a little casually.  It says, "This means that surgically procured organs will be in relatively good health," and, of course, "health" means wholeness, and that's really what we're trying to get at in our definition.

And I just want to raise the question for the Council as to whether we should reserve this word "health" for what we're really talking about: namely, the well-working whole.  And I know it's used colloquially.  "Their healthy organs have been procured from the dead donor."  But I wonder if that is something we ought to not fall into, but speak of health in its proper relationship to the living whole. 

So what do you think, Floyd?

CHAIRMAN PELLEGRINO:  Dr. Bloom and Dr. Kass?

DR. BLOOM:  Just to be very succinct in my responses, the reason I raised the issue of who is Shewmon is that, if I had known he was medically trained and a neurologist, I would have given more than just passing attention to what his comments were.     

If his background was in philosophy or law or something else, these would be things that he had read but not necessarily been able to interpret.  So giving even a footnote of background on who he is at least establishes for me that at face value I have to listen to what he has to say even though I think he's wrong in what he has to say.

And, secondly, let's take some examples at the periphery where all of these things are going on.  The person is even breathing, but they are not interacting in a constructive or a responsive way with their environment.  Are those people alive or dead? 

The Schiavo case, the Karen Quinlan case, where death was only allowed by virtue of stopping the feeding tube, because all these things on Page 36 were going on but that person was not in their environment, I would have said that maintaining that, as the physicians who made the decision finally did, that this was futile treatment, that there was never going to be any recovery and the case should have been closed.

You can get by with no kidneys, you can get by with no liver, you can get by for some time with no heart, and the brain is still functioning.  Those people have an opportunity to be repaired.  But when the brain isn't there, it doesn't matter what the rest of the body is doing.  That person is never going to be a person.

CHAIRMAN PELLEGRINO:  Dr. Kass, do you wish to comment to Dr. Hurlbut's question?

DR. KASS:  I'm first moved, Floyd, if you don't mind, to underscore something Gil said in response to the last time the notion of futility was raised by you.

It's very important, at least for the purposes of this document - and maybe not everybody agrees - that we distinguish the question of when continued treatment is futile because no good will come from it and when what looks to be treatment is mistreatment because you have a corpse whose corpse-like nature is hidden by the fact that the chest is heaving.

And no one, I think, would say that Terri Schiavo was dead.  She might have been dead as a "person," whatever that means.  But no one would have buried her.  One might have been warranted or not in taking the feeding tube out, but that was a decision to discontinue life-sustaining treatment, not a question about pronouncing her dead.

And I think we should remain very clear about the confines of this report.  I don't think you disagree, but I think the wrong impression might have been conveyed.

Bill's question, I'm not prepared to do very much with on one leg, but I don't think you could talk about the many complicated ways in which the human being does all of the human work.

The question at the margins at the edges of life is, "Is there still the human organism present?" and not, "[Are] the powers to philosophize or to make moral judgments present?"  Those might enter into the question of how vigorously to treat or not.  But the question here is, is the patient still here or not?  You know, is it still a member of the human community or is it time to call the undertaker? 

And for there, I think you're talking about kinds of minimal and foundational activities of the work of staying alive without which none of the higher things are possible and in the absence of which I don't think you would say that you have an organism.

And here I think the difference between the living human being and the living chimpanzee, the living or dead human being or the living or dead chimpanzee or the living or dead dog are probably very comparable.  Parasites and amoebae and bacteria are, you know, far away.

But I think we're talking about a mammalian organism, the life and death of which looks fairly similar.  I mean, I could be disputed.  I think Floyd and Dan might have a different take on this.  But I don't think you need a kind of fancy account of the specifically human character of the organism to look for things that are distinctively human in deciding whether we've crossed the line from living or dead.  I don't know if others would agree.

CHAIRMAN PELLEGRINO:  Dr. Lawler and Dr. George?

PROF. LAWLER:  I'm approaching this from the discredited foundation of philosophy and law -

(Laughter.)

- and I think it's a real problem here from a common sense point of view. 

We do want to know when a corpse is a corpse.  We do want to know when dead is dead because you can have "truth" in quotes.  You can have "morality" in quotes.  But you don't want to have "dead" in quotes, like "post-modern dead." 

Although in the short term, there may be some question.  In the long run, we know death when we see it.  It's just this gray, maybe gray, area among the newly dead that causes us distress. 

And I think it was well put.  It's not, you know, when is treatment futile, which was the Terri Schiavo issue, but when is treatment utterly ridiculous because you don't treat corpses.  And most of us wouldn't want to cross the line when it comes to organs, of taking organs from beings who aren't really dead, not sort of dead or will be dead soon or something like, but actually be dead. 

So I think Shewmon has caused in the world of bioethics real doubt. That is, integrated, somatic functioning, which was the basis of the medical consensu,s turns out to be a question because there does appear you can give an argument that the being continues to have that kind of integrated, somatic functioning even if the brain is not working.

So why would anyone care about this?  Why would an average guy like me care about this?  Because some people want to give the most expansive possible definition of life.  When in doubt, go with life. 

So a lot of people want to protect embryos, not because there's a slam-dunk ontological case that the embryo is a human person, but because the embryo might be a human person.  And when in doubt, choose life.  And in the same way, when in doubt, choose life, and so the guy on the ventilator whose brain is not functioning might be alive; therefore, choose life. 

So I do think people of good will are shaken by Shewmon.  People of good will who read stuff like that are shaken by Shewmon.  So we need a new argument, and the big question before us is, is the argument of needful openness really a slam-dunk argument?  Question number one is, that's a slam-dunk argument.  Or the other point of view of Dan and Floyd is, we don't need a new argument because we weren't shaken.     But some people have been shaken. 

But that means a need for openness becomes a question because it's so darned philosophic and so darned interesting and so darned complicated, as Diana pointed out, and perhaps so darned questionable in its own way.

So does needful openness solve this problem that's come before us, or does needful openness show us that we have a pretty good argument here?  But because it's philosophical in a certain way, does it really provide what we really need to extinguish the doubt or were we wrong to think there was doubt that needed to be extinguished?

But in Diana's remarks, she said at the very end - I think she was saying - I have some doubt; nonetheless, I'm going to go with the established medical consensus anyway.

CHAIRMAN PELLEGRINO:  I have Dr. George and Dr. Gómez-Lobo.

PROF. GEORGE:  Thank you.  I agree with Floyd that we need a footnote telling us who Shewmon is.  As it happens, I know him and know about him.  He is a person of distinction.  He is a clinical professor of pediatric neurology at UCLA, and he's the chief of neurology at the Olive View UCLA Medical Center.

But if we're going to engage the work of a person, any person, in the extensive way we do in this draft, then we need to tell readers as well as ourselves who the person is.

Shewmon has become a very important figure, I think deservedly so, in bioethical discussions.  And his work is engaged and treated with respect interestingly across the spectrum of views in bioethics.  But I think it is important that we understand that, you know, his principle contributions are in his area of expertise, and this has to do with factual scientific claims of the sort that Dan has doubts about and wants to know more about and wants to know the evidence about.

He's also intervened or entered into the neuroethics debate and the bioethics debate, and there, you know, he is certainly a welcome participant and has interesting things to say, but they are not within his specific area of professional expertise, and so I think a distinction can be legitimately drawn there.

So what I would suggest is that we do look closely at the specific scientific claims, factual claims, being made by Dr. Shewmon.  And perhaps it would help Dan if we instructed the staff to look at the literature to see what criticisms have been advanced if, in fact, there are criticisms, and I suspect there must be if this has struck you right out of the blocks as having problems.  We could have the staff look at the criticism that's emerged in the literature of his scientific claims.

Now I know there's plenty of criticism on the ethics.  But, again, that I think is secondary to the specific use being made of Shewmon here.  So I think that's one specific suggestion that I hope we can make to the staff because I think it would strengthen the report.

Because of his importance in bioethics and the importance of the questions that he raises, I'm in favor of retaining an extensive engagement with Shewmon in the document.  But I'm proposing to enrich it by looking at what critics have said.

CHAIRMAN PELLEGRINO:  Dr. Gómez-Lobo.  Thank you.

PROF. GÓMEZ-LOBO:  I'm glad that we're having this discussion around Shewmon.  But now I would like to support something that I understood Leon to have said a few minutes ago, and I emphasize it because I think it should be something like a common ground in these discussions; namely, that the notion of death has to be a notion that transcends classes of living beings. 

I think we have one basic understanding of death, and it is the permanent cessation of life.  Stones don't die, but trees and birds die.  And this may seem trivial, but I think it's not because much of the literature on this subject is entitled, for instance, changes in the definition of death.  And that, I think, is a very serious philosophical error.

If you change the definition of the term, you're talking about something else.  If you change the definition of a triangle into a plane figure with four sides, then you're no longer talking about triangles. 

I think for the sake of clarity it's important to realize that we and the generations before us are talking about the same phenomenon.  It's the cessation of life of organisms of any kind.

The debate is, as the report and its very good draft that reads, a debate about standards, standards or criteria for establishing this.  But there has been no change in the definition of death.  In fact, if it were, we would be talking about something completely different.

So I would suggest, and the report I think does this, to keep that as the ground floor.  We are discussing standards.  We are not discussing new definitions of death.

Thank you.

CHAIRMAN PELLEGRINO:  I have Dr. Schaub, Lawler, Meilaender, and Dr. Rowley.  Thank you.

PROF. SCHAUB:  Yes.  Just a very quick question maybe to Leon about the drive for self-preservation.  Why wouldn't we say that things like the sexual maturation of a BD child or the gestation of a fetus, how is that not indicative of the presence of a drive to self-preservation and, not only self-preservation, but the next generation?

CHAIRMAN PELLEGRINO:  Can I interrupt the flow to give Leon a chance to respond to Diana?  Yes, please.

DR. KASS:  No.  This might not be right, but my first impulse would be to say that if you could perfuse and ventilate a corpse so that it becomes simply an, as it were, incubator for a life that happens to reside there rather than see it as the continued work of what would have been the mother, I imagine it would be possible to sustain fetal life in lots of unnatural places and this would be one of the first such.

PROF. SCHAUB:  Could a BD woman conceive?

DR. KASS:  Could a...?

PROF. SCHAUB:  A brain-dead woman conceive?  Not only gestate a fetus, but conceive?

DR. KASS:  I'm going to declare ignorance, Dan.

DR. FOSTER:  Well, I think that would be miraculous.  I mean, I don't want to get into the integration of the CNS (central nervous system) and so forth around here.  I mean, there is powerful new information, for example, that neurons in the brain control the metabolism of glucose in the body.   This is a new Nature paper that's just out.

The intricate hormonal changes that allow one to not only conceive but then to bear a child are so complicated.  Look at what we have to do to try to [conceive children through artificial means], you know, I mean, to do that.

So somebody who has tested brain dead?  I mean, you know, Lazarus rises.  So maybe that would happen.  But I would be very skeptical about that because of the intense integration of multiple organs to allow a fetus to be formed and, you know, and to grow to -

PROF. SCHAUB:  But we do know that gestation has taken place for periods of weeks or months.

DR. FOSTER:  Well, I think Leon's statement - again, this is not something I know a lot about or really am very interested in.  But what he said is presumably one of the things that we talked about in stem cells, would it be possible for us with an artificial uterus to raise parts and so forth along those things?

What Leon said is, "Well, okay, if you put a fertilized egg in an artificial uterus, you likely would see it grow up to some point."  So I don't think that's what you're asking.  I think you're asking by normal courses, could you get pregnant or along those things?

I don't know this, but I'd be pretty doubtful, for example, that the changes in vaginal lining and everything else are normal because you're not generating.  You know, you're going to have panhypopituitarism and everything else, I would think.  So I don't know the answer to your question, but I'd be very doubtful.

CHAIRMAN PELLEGRINO:   Dr. Lawler?

PROF. LAWLER:  Let me just underline that the whole premise of this report is that Shewmon's challenge is important, and the great thing about the challenge is it's spurred us to deeper reflection about the distinction between life and death.

So let me just read the sentence right in the middle of the page on Page 41, the third paragraph.  "Thus, total brain dysfunction can... continue to serve as a criterion for declaring death, not because it necessarily indicates complete loss of integrated somatic functioning, but because it is a sign that this organism can no longer engage in the sort of work that defines living things."

So the point of our report - and I think it's a really important report, very well done - is that given this doubt, we need a new argument.  If the doubt is not worth considering as a genuine doubt, then we don't need a new argument. 

But I actually think, my own opinion would be, the argument is presented brilliantly.  I'm like 98 percent persuaded by it.  And from that point of view, it's a really great contribution to our understanding of what death is.  But if Shewmon is bunk, then we don't need it.

CHAIRMAN PELLEGRINO:  Dr. Meilaender and Dr. Rowley.

PROF. MEILAENDER:  Well, this may not be necessary now that Peter made his most recent comment which seems to me to cut, you know, in a little different direction of his earlier one.

I was going to reply to his earlier one where he had said that this new argument was so complicated.  And obviously it is complicated in one way.  I'm not sure it's any more complicated than the argument it intends to replace about bodily integration.

In another sense, it's very simple.  It's an attempt to provide a very basic kind of understanding or explanation for why we've been drawn to the sort of standard we have for distinguishing between living and dead human beings. 

So, yes, it has its complications, but I think in another sense it's very simple.  And I'll just repeat, to come all the way back to Diana's opening remarks, that part of the attraction of it to me and part of what strikes me as right about it is that what it recognizes is that you can't actually entirely distinguish between domestic and foreign policy, that the two are inevitably connected in a living organism.

CHAIRMAN PELLEGRINO:  Thank you.  Dr. Rowley?

DR. ROWLEY:  I have three short questions or comments. 

On Page 14 at the top under Item 3, the staff says, "The concept of death and the selection of the appropriate standard for determining it are not strictly medical or technical matters.  They are in large part philosophical."

And I wonder.  That struck me as strange because I have thought of death and the standards; i.e., firstly, the loss of cognitive function as well as the loss of respiration and cardiac [function] are standards set by medicine not by philosophy.  But I raise that as a question.  That struck me as strange.

The second question that I have, I, as well as I think most members of the Council , received an e-mail from Mike Gazzaniga, who was unable to be here today, about a report from the Vatican.  Now I haven't seen that report, and at least Mike was very laudatory.  So I think that, as we are working through this report, it would be prudent for us to have access to that because I gather from his comments that the Council assembled by the Vatican did agree in the concept of brain death.

And that leads me to the third comment which is, we've chosen to use a new term "total brain dysfunction."  And I wonder if that's really going to be useful in this in the context of trying to help resolve some of the issues that we've been dealing with.  Thank you.

CHAIRMAN PELLEGRINO:  We have time for one or two more comments.  Leon and Dr. Lawler.

DR. KASS:  Mr. Chairman, this isn't so much a comment as it is a question.  In the draft we received, there is a blank page at the end which says, "Council Recommendations/The Position of the Council ." 

What kind of thing might appear there?  I mean, are we going to be asked either individually or collectively to weigh in on one or another of these views?  That's just, you know, a question.

CHAIRMAN PELLEGRINO:  Questions?  Comments?  Peter?

PROF. LAWLER:  I did with someone else's help a quick Google search on the Vatican and on this issue, and I just came up with the news service blurbs.  So this is very unauthoritative and probably shouldn't be in anyone's record.

But nonetheless it seems that I discovered that the scientists that advised the Vatican are actually divided on this now.  So Bishop Fabian W. Bruskewitz of Lincoln, Nebraska, whose paper from the 2005 meeting is included in Finis Vitae asked how the Catholic Church can accept a lack of brain function as a definition of death and yet still oppose the willful destruction of human embryos which have not yet developed a brain.

So I'm not saying the bishop of Lincoln is necessarily the world's greatest scientist, but he seems to be scientific enough to have presented a paper.  And it appears at the meetings at the Vatican there was a disagreement over whether brain death is still an adequate definition of death.

CHAIRMAN PELLEGRINO:  Thank you.  Gómez-Lobo?

PROF. GÓMEZ-LOBO:  I was going to say something similar to that.  I think that Mike may be wrong in calling it a report because the Vatican publishes lots of things with which they don't agree.  For instance, if you take the yearly reports of the Pro-Life Academy, there's lots there that are just the papers that people have submitted. 

So I think we should take a look at these documents, but they don't reflect, say, something like official teaching of the Catholic Church in any way.

CHAIRMAN PELLEGRINO:  Thank you very much.

DR. FOSTER:  I would just make one other point about Mike's thing.  We talk about Shewmon being - you know, he's the head of pediatric neurology at a private hospital, I guess, that's associated with UCLA. 

But Posner, who is quoted here, clearly is the senior neurologist, you know... I mean, that would be a person who is universally recognized at a different level of clinical neurology, I think, in terms of this...  And if he was quoted correctly, he would be very much in agreement with the sense that the brain is absolutely critical to life, you know.

You can define life.  If you listen to my lecture to biochemists at the medical school next week, you will hear my definition of life, and it's a molecular definition.  Life is the capacity to generate high-energy phosphate bonds.  Death occurs when you can't generate ATP.  Okay?  That's what death is because that's what keeps everything else going at a molecular level.

So, you know, the arguments vary one way or the other about what you define and how you want to define it.

CHAIRMAN PELLEGRINO:  Thank you.

DR. BLOOM:  Well, I just wanted to respond to Janet's third point about total brain dysfunction not being the most mellifluous way to express what it is we mean.            

And I had suggested to Alan that we might consider using the term "brain failure." 

Heart failure, liver failure, kidney failure are all well in the public's mind, and they're not necessarily specific as to the mechanism by which that organ has failed.  And what we're talking about here is brain failure.

PROF. GEORGE:  Could I ask Floyd a question about that, again, just to be clear?

Floyd, when you talk about brain failure, are you talking about what afflicts a person who is in a persistent vegetative state, or are you talking about what we have heretofore referred to as a brain dead person as opposed to a brain damaged person in a PVS state?

DR. BLOOM:  I was talking about it in the sense that Peter's last quote from Page 41 talks about it and the inability of that individual to interact with the environment as the work of the individual.

PROF. GEORGE:  So would a PVS patient have brain failure?

DR. BLOOM:  It has a form of brain failure, yes.

PROF. GEORGE:  So such a person would be dead?

DR. BLOOM:  That's where we are.

PROF. GEORGE:  But not according to the brain death definition that we have been working with and that Shewmon and others have called into question. 

But I think it was Leon who said, I mean, no one was saying you can bury Terri Schiavo.  The debate is about whether you could take steps that would result in her dying, the assumption being she was alive before those steps are taken.  Am I wrong about that?

DR. BLOOM:  I should let Leon answer that question because it was he who raised the actual complex dividing line.

DR. KASS:  No.  I thought I was going to come to your aid, Floyd, and say all you need is total brain failure.  And you would say of Terri Schiavo, not quite total.

PROF. GEORGE:  So she wasn't dead?

DR. KASS:  That's what I think, I mean, by these criteria.

PROF. GEORGE:  I'm happy enough to go along with the use of the term "brain failure" if it refers to what we generally refer to and have been referring to as brain death.  Then we can talk about whether we want to retain that understanding of death. 

But I would be very dubious about moving forward if we're identifying brain failure with death and we would understand people who were in persistent vegetative states as having brain failure.

CHAIRMAN PELLEGRINO:  Dr. Carson?

DR. CARSON:  I just want to bring it back to a practical level because, you know, as a neurosurgeon, we deal with these things of brain death and brain failure all the time.

And, you know, we in the medical profession know what a brain dead person is, and there really isn't a whole lot of controversy about, you know, ceasing to treat those individuals except if organ procurement is on the table.

However, the ones who have significant brain dysfunction engender a lot of discussion.  People recognize that they are not dead.  However, they also recognize that they are not people who are not going to make any kind of a recovery.

And in those situations, what is practically done after discussions with the family are measures are taken to allow them to move on to the state of brain death and then, you know, things are withdrawn at that point.

It's practical.  It's done every day.  And, you know, I just hope that we can reflect some of the practicalities of what is done in normal life in medicine.

CHAIRMAN PELLEGRINO:  Thank you.  Let me point out first in answer to Leon's question earlier, yes, we would like to have your comments on any recommendations we might make.  I think we would like very much as we indicate on the very last page of the material you have of the report itself to know what you think about that on an individual basis to repeat once again the invitation to each and every one of you to express your personal view on this.

I take this to be, just as all of you do, an extremely important question to be addressed.  I'm very much concerned, Robby, about the question you asked toward the end about the permanent vegetative state.  We had a presentation in which it was suggested to us that those patients were eligible for removal of organs, and I personally would certainly strenuously oppose that.  But that's beside the point.   

But on your question, Leon, we want to have further recommendations and further emendations if possible.  This is important enough so that when we make the contribution it's clear that the opinions of the members of this Council are expressed, and it's not the kind of thing where we may be able to come to complete resolution of all the issues and make a recommendation that everybody would agree to unanimously. 

But our purpose is to lay out those issues for the public and where are we on this important question, which leads me to the second point that this report, of course, is related to the report which will be given to you for the next meeting for a detailed discussion on organ donation which you've heard about and we're now at the point again where it has been edited and looked at again and again and will be back to you for further comment.  So these two have a relationship one to the other.

And, Robby, to just point out quickly, your question about the critics of Shewmon, I think in [Alan] Rubenstein's summarization of the paper he did address the critics of Shewmon.  I know that Dr. Bloom feels perhaps we've given too much attention to Shewmon, but Shewmon has raised the question over and over again and I think it needs to be dealt with.

Insofar as the Vatican position goes, I think Gómez-Lobo has reported on that.  I'm a member of that Council as well.  I won't take your time to go into the details of the conversation. 

But my general feeling is that the members of the Council do, indeed, feel this is sufficiently important for us to give our very, very close attention to it.

Dr. Dresser?

PROF. DRESSER:  In terms of recommendations, I think we could look at Pages 9 and 10 for a barebones statement of the sort of objectives of the report and then see whether that needs supplementation or there's some concurrences and dissents and so forth.  But that seems to me to present a draft of recommendations.

CHAIRMAN PELLEGRINO:  Thank you very much.

If there are no further comments, we'll break until perhaps, oh, 10:30 or 10:35 at the latest to reassemble.  Thank you very much.

(Whereupon, the proceedings in the foregoing matter went off the record at 10:21 a.m. and went back on the record at 10:54 a.m.)

Session 2: The "Crisis" in the Ethics and Profession of Medicine: A Historical Perspective

CHAIRMAN PELLEGRINO:  Can I ask the Council members to be seated please?  Thank you very much.  We'll now resume our agenda.

The next topic for the rest of the day will be on the "Crisis" in the Ethics and Profession of Medicine.  And we begin with a very distinguished commentator and author in this area, Dr. David Rothman.

I have explained to Dr. Rothman, who understands clearly, of course, our custom which is not to provide long introductions, and he said he was relieved, and I'm glad.  And so I will ask him forthwith to address us and then the discussion will be opened when Dr. Rothman finishes.

PROF. ROTHMAN:  Thank you.  I can tease with Dr. Pellegrino.  If you can accumulate enough titles, you don't have to give your talk -

            (Laughter.)

            - particularly, you know, when you get these 20-minute versions of it.  I have longer today, and I very much enjoy the chance, [first], to appear before you and speak to you.  I know several of the members of this commission for some years.  And, secondly, it's a good subject, and I'm hopeful that the pleasure that I got in sitting down and doing this for you will be matched by your finding what I'm about to say interesting.

Dr. Pellegrino and I are both members of that generation that came of age well before PowerPoint.  Since I was in arts and sciences before going up to the medical school, I didn't even know from slides.  We just simply talked from notes or text.  Yet, I have converted and Dr. Pellegrino is suggesting to me9 maybe in [confidence]- I'm not sure0 - that he's beginning a little bit to convert to PowerPoint as well.  It's a very useful tool.     So I haven't used as many as I might otherwise have done out of respect for Dr. Pellegrino's bias.  On the other hand, it was hard not to at least be able to say something using the technology.

I'd like to open my analysis of the state of the medical profession, the putative crisis it faces, and the locus of responsibility for making change by recounting to this august group how another group responded to the very same issues.

The group whose experience I'd like to share with you is the Board of Trustees of the Institute on Medicine as a Profession, IMAP, a 501(c)(3) public charity of which I am the president.

IMAP itself was created through a generous gift from a noted philanthropist, George Soros, a man who made his fortune in the marketplace obviously, but a man who was totally convinced that marketplace values should not dominate all sectors of the society.  In particular, the professions, medicine and law, as the exemplars, have responsibilities that ought not to be driven by the market.  This was very, very much his position, a position that I share, and I suspect many, if not all, in this room will share.

Doing justice from the legal side and promoting health in our territory are obligations that go well beyond the bottom line.  It was that kind of thinking that led him to endow the Institute.  The Institute itself carries out its work through a center at Columbia College of Physicians and Surgeons.

IMAP has a board of directors, trustees, if you will, and the first meetings post the gift were devoted to defining its mission, the Institute on Medicine as a Profession.  As it would be expected, the group wanted to spend a certain amount of time defining professionalism, how it might promote it.  But what might not be expected in these early deliberations was a dialogue that we got into and actually stayed into for a surprisingly long period of time.  And it's that dialogue that I want to recount to you.

The first impulse of the group was to set out the challenge, medicine as a profession, and set it out in terms of a revival of professionalism.  We have to look back, recapture, restore, you know, if you will, all the "RE" words.  Recent developments have eroded professionalism, the opening hypothesis was, so our efforts should be revitalization, recovery.  You can fill in more and more synonyms.

But before we even could go very far down that path, we all recognized a fundamental inadequacy of framing a program in terms of restoring - and I don't mean it quite pejoratively, but perhaps there's a little inkling of it - restoring the good old days.

So as the slide shows, we called it and we began to talk about it in terms of the so-called good old days.  Did we really want to revive, restore, rediscover a profession that was all male, almost all white, and almost all upper-middle class?

I keep wondering.  You know those photographs, you've lived with them.  We have them at P and S [College of Physicians and Surgeons], too.  You know, the class of house staff from 1910 and 1912.  You know those photographs:  Lily white, [and all] male.  I mean, occasionally maybe a woman, maybe a person of color.  But those are stark white photographs.  And we do know the socio-economic origins, the upper-middle class, as well.  So before one got too rhapsodic about going back to the good old days, certainly we didn't mean to do that. 

And then we would go into financial issues, which we'll be talking about today.  Conflict of interest was certainly present; fee-splitting, an absolutely common habit.  The surgeon had to reward the referring physician.  He did it in a variety of ways, sometimes the charade of that surgeon bringing in the primary care provider to the operating room.  One way or another, they figured out how they could gift, if you will, the referring source.  The practice hasn't altogether disappeared.

I love California wines, saw an advertisement in The New Yorker for a kind of California wine-of-the-month club, was curious about it.  On home stationery, home stationery, I wrote and asked for the brochure.  It came back with a first-cover insert kind of thing which said, "The perfect way to thank the referring physician." 

            (Laughter.)

Somebody at that wine company knew how to market its product.  Fee-splitting isn't over.  But, I mean, again, my caution is, we're not going to get so rhapsodic about the good old days.

Direct dispensing.  A not uncommon practice. 

Fee-for-service.  In a group like this, I don't have to expound on the potentials of conflict of interest there.  But certainly, you know, returning the patient for a visit, it happened, part of the roster.

Drug company largesse, which we'll spend some time on this morning as well.  It's not a post-1990 phenomena.  It goes way back and was, if anything, perhaps - well, I shouldn't say that.  But it's effectiveness may have increased.  But it's certainly a phenomena as part of the good old days.

And even public complaints about doctors' income, which you see a lot of in the press, nothing really new about that.  The 1950s saw a spate of journalist accounts of doctors including one that I always tell my medical students that involved a child in a Midwestern town who fell down an abandoned well.          

He opens his book with this.  The town spent about a day and a half.  Everybody - you know, the fire department, the citizens - digging, you know, doing all the rescue operations.  They rescued the child.  They give the child to the physician for care.  The physician delivers the care, and then the physician has the audacity to bill the family.

Well, this became newsworthy.  How could you have billed?  It made its way to the AMA.  As I followed the story, I wasn't sure what the AMA would do.  The public uproar was so great that the AMA said the doctor was wrong.  I tell this story, not for the rights or wrongs of the charge, but that public complaints about physicians' income has a long history. 

Damned if you drive the Cadillac, damned if you don't.  Patients want their physicians to be "big men."  On the other hand, you know, I mean, the only reason that I'm playing this out for you is I don't want you to think that the current kind of critiques have anything unusual about them.

And the last two bullets are, of course, perfectly obvious to you.  The strong bias against group practice and the extraordinary bias against government intervention, the case in point, of course, being Medicare.  So before you get too rhapsodic about restore and rediscovery, we really don't want to go back to those good old days.

Then, you know, the dust would settle.  Everybody's outrage, you know, would calm down.  And then we would say to each other, "Okay.  So our task is to invent professionalism.  If we can't restore it, we should invent it."

But that was, again, a kind of frame that could not exist for very long.  Everybody in this room and everybody in that room knows it well.  The Hippocratic oath dates back and, you know, if you want to bring a laugh to a medical audience, all you have to say is, there is no Hippocratic oath for lawyers.  It's the medical students at commencements who recite, not the business school students.  You know the rest of that litany.  And it's a powerful document, obviously amended by almost all of the medical schools that use it.

But the key values - confidentiality, do no harm, respect for the body of the patient even if the body of the patient - you'll remember that line - is the body of a slave.  I mean, that's startling in its way.             

So, I mean, invent when you have that kind of tradition? 

And medicine as we do know and we recognize had a long tradition of serving the under-privileged.  In pre-Medicare/Medicaid days, there was a Robin Hood quality about medical practice.  Well-to-do patients paid more.  Poorer patients paid less.  And many physicians to this day serve patients' well-being impervious to the clock, the day of the week, the nature of the holiday.  So "invent" seemed, if you will, totally presumptuous.

We went round and round this cycle of revive/ invent several times, and we soon recognized that the internal debate we were having matched up quite well with the academic debate that had gone on within the history and sociology of medicine over now almost the past 90 years.

In the 1930s, the major frame or analytic context for understanding medical professionalism was the work of Talcott Parsons, a famous sociologist.  I suspect some of you have read him as well.  Parsons treated medicine as the quintessential profession.  This profession, he argued, had a collective orientation, and he very, very clearly contrasted it to business, which was self-interested.

For Parsons, the financial self-interest that business characterized as normative was outlawed in ethics and the practice of medicine.  He was altogether confident in declaring that patients should put themselves in doctor's hands, do as they were told, commit themselves to recovering.  No patient activism there.  You listened to your doctor.  You did as your doctor told you.

Parsons did all his field work at Mass General.  A very sophisticated sociologist, he had no trouble thinking that Massachusetts General, MGH, represented the world of medicine. Startling as we read him but very, very much there, professionalism in his context and his influence, I think you appreciate.  Professionalism, doctors serving patients' best interest, was the hallmark of the field.

But in the 1950s and 1960s, a very different line of interpretation comes to dominate this territory.  Professionalism now becomes the synonym for guild monopoly.  Restrictions on entry to the profession, exams, licensing, these are not intended to maintain quality, the school argued, but to restrict the number of practitioners.  And why restrict them?  Obviously, so that those already inside would be able to protect and raise their incomes.

Self-regulation was a sham, variations on the fox guarding the chicken coop.  Physicians in this school had only one goal:  Protect their own and advance their own financial interests.

Well, those two rival schools, if you will, one succeeding the other, as you look at this over the past 10, 15 years, the wheel of interpretation has turned again, not all the way back to Parsons but quite close.

Professionalism now has become the best hope for resisting the demands of managed care or any profit-seeking managers and auditors.  The patient is to be represented and stood up for by the doctor.  Indeed, because the government was not only a payer but the payer, professionalism had to resist its intrusions as well.  And as I think everybody in this room recognizes, we've had a fabulously intense revival of professionalism, and we are almost back in the days of Parsons.

So two important findings.  I think I want to draw your attention to this little anecdotal survey:  One, there is no single historical line of interpretation that will resolve the question of whether past crises are more severe than current ones.  You know, whichever frame you prefer you may adopt, you can emphasize, you can stress.  But there is no one line of interpretation that will enable you to say "Back then, it was so good.  Now, it is ... don't go down that road, I would urge you." There is really no way of saying whether the profession has deteriorated in its performance, whether doctors are or are not less committed.

Second, in the case of my own organization, we found ourselves, after we went round the wheel abandoning the issue, trying not to resolve the past record, but defining ourselves in terms of future action.  We take as our fundamental challenge, leaving aside this historical context that I provided you with, our fundamental challenge:  What is the role for professionalism in the 21st Century?  Going forward, what does it mean to make professionalism a force for change?

Clearly, the practice of medicine is different today than it was 50 years ago.  It's different in what it can do.  It's different in what it should do in terms of best practices, fundamental differences in who does it, differences in practice conditions, and differences in reimbursements.

The assignment then becomes, given these changes, what do we do to enhance, promote, use professionalism as the guide for action?  What considerations, whether in medical education - which you'll hear from later today - in medical practice, in physician's behavior, in health policy, what difference should professionalism make?  And in the time I have with you this morning, I'd like to begin to suggest some answers to that question.

I've avoided until now, but it's not a serious issue, the definition of what we mean by professionalism.  Perhaps surprisingly, although not in a room like this, there's a good deal of agreement on just what its attributes are:  Altruism and commitment to patients' interests, the starting point for everyone; profession as self-regulating, clear to everyone; the obligation to maintain technical competence, again clear to everyone; civic engagement, which I'll only say a word or two about in a moment, a little bit more controversial.  But there are those of us, and I think you've heard from them, too, over the past several years who would put civic engagement in there as one of the attributes of the profession.

I'm going to come back to the key altruism point.  But I want to begin with the others because the altruism and commitment to patients' interests is so important and so complicated, if we begin there, I'm afraid we won't get out.

Professionalism's commitment to self-regulation.  The historical record is weak.  If I was going to more aggressive, I could say pitiful.

The tradition of passing on troublesome colleagues to the next institution.  Every major institution that I know of and have been affiliated with is totally scrupulous in terms of who gets to practice medicine under its umbrella.  I mean, you know, I know this.  I experience it.  And if there are lesser physicians in terms of talent, etcetera, etcetera, you know, a friend is going to go there, I will be told immediately, "Uh-uh, not there.  You go here.  Thank you."

As institutions, we are terrific at monitoring the capacity and quality of our fellow practitioners.  The problem though is that our loyalties are very institution-bound, and we have no difficulty often in passing on colleagues that we would not send our relatives to to the next institution.  Periodically, scandals will break out, and New York has had its share.  We don't do a very good job outside of our own turf.

Failure to police activities.  We just came off a fabulous scam in whole-body scans.  Right?  I mean, a useless, expensive, anything-but-evidence-based procedure, although it collects a good - collected, I'm happy I can use the past tense.  I mean, obviously the major professional societies did, you know, in the radiology world say uh-uh.  But very, very little concerted action taken to really put an end to this.  I mean, you know, let a scam come up.  You don't see a lot of organized action to take it down. 

Anti-aging clinics, cosmetic claims, the anti-aging claims.  Manhattan has several.  I'm sure Florida, Arizona, California beat us by the many.  It is a scam.  Many of us in this room have a real stake in anti-aging claims would that they were valid.  But I think most of us in this room would suggest that giving 75-year-old men heavy doses of testosterone might not be the thing you want to do.  And we've learned, despite all the complexity, etcetera, etcetera, giving 65-year-old women estrogen is not the thing to do.  Growth hormone - I mean, you know the litany. 

And yet you can walk on the East Side of Manhattan as well as in these other states, and there they are.  There's even now an anti-aging [specialty] - I don't know.  I think they call themselves that.  It's not recognized by the G and E [graduate medical education] world.  But there it is in medicine's record, so to speak, and taking these things down is not very great.

Maintenance of technical competence, reducing medical error.  There the profession has done a more credible job.  But the challenges it faces are going to be quite extraordinary.  The chart which was once thought of as, if you will, in private practice belonging to the doc, if not, in institutions, making the chart transparent, the use of information technology; sharing data, somebody looking over your shoulder; recertification - I think many of you in the room will know the stories of what happened of when the ABIM tried to put in recertification - resistance, but it may yet come through.  The younger generation is perfectly comfortable with it; and the evidence-based medicine debates, which are quite fierce. 

I've just finished reviewing Jerome Groopman's book [How Doctors Think].  The reviews didn't talk about this, but I certainly do.  It's a polemic in a variety of ways against evidence-based medicine.  It's going to ruin the clinical intuition, and he comes out very, very strongly against it.  He was worrying about clinical insight.  Many others, of course, worry about the failure to do what ought to be done, whether it's the use of beta-blockers or, you know, other interventions.  A major area, and one I think that's going to see enormous amount of activity.

I won't spend much time on civic engagement except that the data is overwhelming that physicians do not participate in community affairs, and I'm allowed to say, even pediatricians who lead the pack don't lead it by a lot.

You don't find physicians participating often in public discussions.  It's a much more reclusive profession except for many of its professional medical associations.  But most of them spend their lobbying money on protecting members' interests.  They are member-interest driven rather than advocating for the public good.  This is not always true.  Pediatrics, some of the medicine groups can escape it. 

In the New England Journal of Medicine piece that is in your packet, I said something which brought me more shouts and screams than most things that I say.  I was dealing with this question of advocating for more than pocketbook interests.  And there's a quip in there, "would that ophthalmologists rather than GI guys advocated for colonoscopy."  Well, I mean, I meant it in just this frame.  You can't imagine the invective that I got.  Don't you know the difference between an eye - you know, you can fill in the rest. 

I was tempted to remind some of my writers that ophthalmologists to the best of my knowledge had received MD degrees and might be perfectly competent to review colonoscopy-funding decisions.   But what I was trying to do was to get out of the box.  It was not a particularly well-appreciated line.

Let's come to the core issue, altruism and commitment to patients' interests:  money versus medicine, the HMO/hospital/group  practice/financial incentives, the drug company gifts and payments.           I mean, I've already given you a frame that says it ain't quite as new as some of those who worry about this may believe, but it is certainly hot on the public agenda.

I use this slide for a purpose, and it's not simply to wake up a sleepy audience, which is not this.  A physician:  "Try this.  I just bought a hundred shares."  All right, now this appeared in The New Yorker about a year and a half ago if I remember.  I don't want to spend a lot of time deconstructing it.  But just do the thought process of the presumptions among those who edit The New Yorker and its readers, you know, that this will be understood, will be seen as funny.  This builds on a lot of assumptions that suggest that ultimately the professional is really money-driven.  Parsons notwithstanding, this is what it's about.  That this is seen as understandable and humorous suggests a quite jaded public view of exactly what's going on.

This slide comes from The New York Times as you see.  On the weekend, she's a cheerleader.  During the week, she's a drug rep.  When I'm lecturing the medical students, I remind them that once upon a time in the '60s and '70s - Dr. Pellegrino will probably agree - the anatomy course would, you know, throw in pictures like this even a little racier to wake up students.  Now we're at '05.          

And, again, what does this say about the profession to the public? 

I will share quickly a humorous story.  I had been doing some work in China on issues of professionalism.  They were interested in it for a variety of reasons, and I sent this slide.  And then I had some second thoughts about it, did I really want a Chinese audience to deal with this?  And I wrote to the convener of the meeting and said, "Look, take that slide out."  And he e-mailed me back very quickly, "Yes.  We will take this slide out and we're delighted that you made this decision.  Our translators couldn't figure out what a postage-stamp skirt was," the dangers of doing cross-cultural work.

(Laughter.)

The press coverage.  For a project that I'll tell you a little bit about later, we had one of our researchers just cover the press, you know, over July, the extent of it, a lot of it in The Times, a lot of it in The Journal.  But it goes out to The San Jose Mercury News, "Science critics ... Financial Ties", "Financial Ties to Industry ...", "Hospital Chiefs Get Paid for Advice on Selling to Hospitals," "Indictment of Doctor Tests Drug Marketing Rules."  I mean, again, it goes on, "... Conflicted Medical Journals."  Look, this is the reading public.  A week?  You know, I keep a pretty extensive file.  There can't be a week when I don't add to it on conflict of interest, and it's almost every day between The Wall Street Journal, The New York Times, The L.A. Times, The Philadelphia Inquirer.

Many of these reporters, by the way, are not in the health section but in the business section.  So the public is getting a pretty steady accounting of conflict of interest, and it's very, very much on the public mind.

It was knowing this that the ABIM Foundation, at that point in time headed by Harry Kimball, and my organization got together to see what we might want to say about conflict of interest questions given their extraordinary prominence.  In the room is one of my colleagues who worked on this, Susan  Chimonas.  You'll be hearing later from Jordy Cohen.  You know many of the other names on here from Troy Brennan to Neil Smelser, Jerry Kassirer. I mean, you know these people.

We spent several years, two to three, doing this piece and found our task - well, we found two things.  One, we had to create, so to speak, a table of contents which I'll show you in a moment.  What were the major issues that ought to be on the table?  And simultaneously we really tried to give an account of what we thought should be done.  You know, what are our recommendations to deal with these issues?

I will say here that the group began very moderate in its posture.  Given my training, I would call them, if you will, moderate abolitionists, gradual abolitionists, don't move too fast.

The more the group stayed with the issue and the more the analysis went on both in terms of information about the practice, the impacts of these various practices and our own sense of what should be done, we became, if you will, Garrisonians, immediate abolitionists. 

And this is a fairly consistent, if you will, abolition document.  It's had, I mean from our perspective, a wonderful more neutrally-put extensive impact, maybe even more because we set out the table of contents in the left-hand column, the activity that, you know, we worried about.  I mean, the left-hand column has now become, if you will, the checklist as more and more institutions review their own policies on conflict of interest.

We limited ourselves incidentally to academic medical centers because we could find no easy way to influence community physicians.  That seemed beyond us.  But at least academic medical centers, centers which did all the training, centers of influence, there we could speak to them.

Gifts, meals - eliminate.  You can read this.  Samples - indirect, not in the doctor's office.  Speakers' bureaus and ghostwriting - I mean, scandalous.  The ghostwriting, it's hard to imagine anybody accepting this.  This is what we throw kids out of college for.  I mean, where we come from, it's plagiarism or something of that sort.

Speakers' bureaus - we're not talking about honoraria.  That's a separate list.  We're talking about joining the speakers' bureaus and becoming the hired hand of the drug company - shill, commercial sex work, I don't know what terms you want to use - infamous.  And there we had no problem saying eliminate.

Payments - okay, but get it out of direct support for CME, get it out.  Don't let the division chief or the chairman pick up the phone to call the drug company to say, "I need $20,000 for...," that sort of thing.

Consulting, honoraria, and research contracts - we did not say no.  I mean, we recognize fully well that, if you will, pharmaceutical companies are not tobacco companies.  We appreciate that.  You can't end all the nature of the relationship.  And the cheap shots that were taken at us were, "You're demonizing the pharmaceutical company."  We're not trying to demonize the pharmaceutical company.  We were trying to eliminate as far as we could conflict of interest in this arena.

Consulting, speaking honoraria, and research contracts have to be maintained.  But we do ask for transparency, but real transparency.  Specify the terms of the service, make them available for public inspection, let it be known how much.  You know, you'll see the disclosures in journals.   Consultant to X drug company - $100, $500, or $500,000?  It does make a difference, and that urge on our part to render it transparent we think is crucial.

Formulary and other purchasing decisions - decision-makers must be conflict-free. 

After the appearance of that article, I received a phone call from Pew Charitable Trusts who read the piece, saw the press coverage of it which was extensive, and then asked an embarrassing question:  What did your committee think to do the week after the report was released? 

Our committee in truth, as I told them, had not spent five minutes on what we would do after the release.  Here's our view, but, I mean, we spent not a moment on what we might think about in terms of implementation.  Pew Charitable Trusts is many things, but it's not the IRS.  So when it says, "Think about it, and we'll help you," we were prepared to start thinking about it and we did.

The prescription project, funded handsomely by Pew, is working in a variety of areas, the two areas most central to our conversation today and really most central to the project, to see what we can do to change conflict of interest policies at academic medical centers.

There are some lead groups out there:  Stanford, Yale, Penn - you'll read tomorrow about BU - Wisconsin, Michigan, Kaiser.  It means a lot of forward action.  The wind is to our back and we'll see what we can do in that territory - translate prescriptions into practice and the very same thing with professional medical societies.

I give you this and tell you this background to it because you are obviously quintessentially in the formulation area.  It was unusual for us - we were not prepared for it - but we are finding it very exciting to look at actually changing practice in an area that we have been studying.

Where do we go from here?  I worry.  I worry a lot about "professionalism lite."  I hear a lot about this.  I get anxious when professionalism gets equated or swallowed up by good manners.  Look, good manners are very, very important.  I don't want to discount them in people or in doctors.  But that's not the sum and substance of professionalism. 

Humanism is important.  Look, I come out of the social sciences and humanities, not out of medicine.  And, you know, the humanistic spirit, god knows, is important.  Again, I don't want to - you know, I think it's important that medical students read literature, although I will tell you as you already know and can remember, there are professors of literature that I would no more trust to be good-mannered or acting in my best interest than anybody else.  But humanism is important, but they are not substitutes for substance.

My last slide is probably my most controversial slide.  Professionalism lite is easy to put down.  At least, I think it's easy.  I think it's really important to talk about what it really means to advocate for professionalism. 

Put patients' interests first, but don't coddle that.  That really is meaningful.  Look, you may have to take a financial hit.  That's what it may mean.  You know, speakers' bureaus are fabulous.  They'll send you to Hawaii and they'll pay you X-teen thousand. 

One dean has mentioned to me that as he put in a ban on this sort of activity an angry colleague came up to him and said, "You are now depriving my children of their college education."  Okay?  I mean, rhetoric, not rhetoric?  I don't know.  But you certainly can get the heat up.  If you mean it, this is what it means.  You know, if you're really going to talk about it, this is what it means.

Technical competence?  Sure.  But it means you're going to have to let people look over your shoulder.  None of us like having people look over our shoulder.   That's not the most pleasant activity, but that's what it really means.

Self-regulation.  You're going to have to say something.  From my context, you know, the guy who is handing out testosterone, you know, like it's life-savers, do something.  Report a colleague.  It's not comfortable.  None of these is comfortable.  But ultimately I think they're crucial.

The last slide, you know, the last bullet, physicians will campaign for public benefits, not private reimbursement.  Change the orientation of professional societies.  Members may not like it, but that may simply make the issues all the more important.

Thank you for listening.  I've enjoyed the chance to present, and I look forward to the discussion.

CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Rothman.  Dr. Dan Foster, a member of the Council , has graciously agreed to open the discussion.  Dan?

DR. FOSTER:  I didn't really agree.  I was just told to do it.

            (Laughter.)

CHAIRMAN PELLEGRINO:  But you were told graciously.

DR. FOSTER:  Well, I think that, I mean, there are many things that one could comment on in the report and very little that I think that I would disagree with.

The first comment I want to make is that the good old days of all-white males are completely gone in most academic centers, I'm sure.  I was at Columbia not too long ago.  White males are an endangered species in medicine.  We have 55 new interns and four are white men.  I mean, it goes back. 

There are no, almost no, white males going into medicine anymore and for complicated reasons.  There are many women and, of course, a huge number are of second-generation persons from Oriental and other [ethnic backgrounds].  But that one, we don't have to worry about anymore.

Secondly, the traditional views of professionalism, as you pointed out, go back a very long time and were much narrower than the social issues that you have talked about here.

Osler in 1902 gave a great talk in which he started off - he had four things to say about medicine and what it should be.  He said it had a noble heritage, that there was a long line of true physicians that went back to the founders like Maimonides and Hippocrates and so forth, and that he was asking the guild, as he called it at the time, to take their place at the end of this long noble line.  He believed that it was a noble profession.         

And if you go back and read the history, that term "noble" enters very often.

Secondly, he said that it had a remarkable solidarity to track to their sources the causes of disease and to make these new findings available to everyone.  It was not a solidarity of race or sex or political meaning.  It was to fight disease.  It was to prevent premature death and cure disease when that was possible, that it was to alleviate symptoms when cure was not possible.  It was to comfort always, the priestly function.

Third, he said it had a progressive character.  In his day, they were shifting from magic to science, and they did it.  They made that change.  That meant that one was a life student.  It has to do with your issue of technical competence, which is not easy.  I'll comment in just a second.

And, finally, he said, it had a singular beneficence.  He said the relief of human suffering was such to make the angels sing.  We don't talk like that anymore.  But this was the core of professionalism in Osler's view, and I think that still holds very much.

The technical issues are not solved by evidence-based medicine.  One of the real problems is that you have very good studies by very good people who come to different conclusions.  For a long time, we believed that estrogen replacement would be helpful in terms of heart failure and so forth in women.  Everybody agrees that this was a solid statistically-wonderful study, and then it changes.  And they change in different parts of the country, so it's not - and then you worry about a challenge to the nature of journals that 35 percent of their statistical analyses were no good and they didn't believe it, and they reproduced this from the Spanish statisticians that challenged it, and it turned out it was true.

So oftentimes the - and the meta-analyses that everybody pays attention to about, you know, whether this - I think most scientists are really skeptical about that because you don't know.  You're giving equal comment to studies of all sorts of things, old people versus young people, all sorts of things of that sort, so it's a problem.

And then in the traditional sense, Joe Goldstein in his last career award - I can't remember whether I mentioned this before sometime.  But in 2004 - and I didn't check it - there were 550,000 papers published in the biomedical literature in the 4,000 journals that the National Library of Medicine archives in PubMed and so forth. 

550,000 - that's more than a paper a minute.  Now let's say that only one of 1,000, Goldstein said, if only 1 of 1,000 is important, that's still 500 major papers that a practitioner and a scientist has to keep up with to do it, and that has nothing to do with this issue of somebody looking over and what best practices are.  It's much more complicated than that, I think, and much more difficult than to be dedicated to try to learn those things.

And I think the last thing that I want to say is that it's very easy to recommend to others that their income ought to go down.  As Bud Relman said last week, "You can't go to any major city in the country and find an internist for an aging patient."  People won't take Medicare anymore. They don't follow their Medicare patients, because their income goes down.

I have a son who is a general internist, and he's very good.  He admits his own patients to Baylor Hospital and so forth, and he has a wonderful group.  His income has gone down every year for the last four years.  And he doesn't do anything shady.  I mean, he doesn't give Botox or anything like that.

But I'm not talking about big money.  I mean, there are some people that make big money.  I'm talking about trying to make $100,000 a year as a general internist.  I get $40 for seeing them.  I'm a professor, but I get $40 for seeing a patient for Medicare.  We still see them...   Internists are very demoralized these days because of these changes in money and so forth and the fact that it goes on here.  And we had taken our dog to the veterinarian, two dogs we took for a bath and shots.  And it was $250 cash upfront.  And I get paid months later $40 for seeing a patient.

So there's a worry about that.  And then to say, "Well, you're going to have to take a hit financially if you're honorable" - that's sort of what it says.  And that's probably true.

But that's very easy to say when you're not - and I'm not speaking about you at all, you understand.  But it's very hard to find people to even go into general internal medicine anymore to get people who will take care of real patients, not subspecialty.

And the last thing I would say is that I don't think - I know you're not attacking drug companies.  But almost everything that happens, one has to look for somebody who must have some interest to give significant money. 

I'm the president of the Academy of Medicine, Engineering, and Science in Texas.  That's all the people who are members of the national academies that live in Texas.  And in response to the gathering storm report of the National Academy about the failure of their - there's a great editorial in Science this week about stem and so forth. 

But we took on at the request of Senator Kay Bailey Hutchinson, our senior senator, the Academy is going to study the teaching of math, science, and technology in the Texas schools.  This aca