November 20, 2008
Council Members Present
Edmund Pellegrino, M.D., Chairman
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
Jean B. Elshtain, Ph.D.
University of Chicago
Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School
Michael S. Gazzaniga,
University of California, Santa Barbara
Robert P. George, D.Phil., J.D.
William B. Hurlbut, M.D.
Donald W. Landry, Ph.D.
Peter A. Lawler, Ph.D.
Paul McHugh, M.D.
Johns Hopkins Hospital
Gilbert C. Meilaender, Ph.D.
Janet D. Rowley, M.D.
The University of Chicago
Carl E. Schneider, J.D.
University of Michigan
SESSION 1: MEDICAL FUTILITY
CHAIRMAN PELLEGRINO: Good morning. We're accustomed to starting on time. Thank you to all of the Council members who are seated and ready to go.
Welcome to the Thirty-Fifth Meeting of the President's Council. My first act always has to be to make this an official governmental gathering by acknowledging the presence to my left of the Executive Director of the Council, Dr. Daniel Davis . Thank you for giving us legitimacy, Dan, and we will now proceed with the meeting itself.
I want to thank you, the whole Council, for responding to our need to accelerate the Newborn Screening White Paper, and it will be distributed in an electronic format to the President and the Secretary of HHS and a key list of recipients on Monday, November 24th. It will then be printed and distributed in the usual fashion.
This is just a summarization of where we are on the reports. As you know, we have quite a few waiting to see the light of day in the outside world. The white paper on the Determination of Death will soon follow with the same sort of distribution process that you heard for the previous report: Initially, in electronic format, and then in the usual printed format.
Also on Monday, the 24th, you will receive another draft of a white paper on Healthcare and the Common Good for your review and comments. I hope you will respond as you have in the past as promptly as possible because the time is an issue.
The next item will be the final revised draft of the Organ Transplantation report which is also virtually complete. We moved it from the head of the line to the back of the line in order to get the Newborn Screening finished and the reviewing process for the Healthcare White Paper underway.
So we have several things going at the same time in what the architects call "fast tracking," several things going parallel with each other is difficult, but hopefully not too much.
Today's meeting concerns three topics as you know, I am sure: medical futility, conscience, and the past and future of public bioethics. We're going to begin with medical futility. And as the Council members know, we do not indulge in long introductions, and, particularly in this case, we don't need one.
Dr. Schneiderman has been working in the field we're talking about for a considerable time and I would say is the preeminent scholar in this field, and he is going to be talking about the question of futility that seems at times perhaps to be too confined in the narrow clinical situation but has, I think, increasing public implications and even policy implications. For those of you who may have read about the case of the little boy and the question of intervening outside of the constellation of decision-makers, physicians and family and so on, and this is happening with frequency.
Dr. Schneiderman, would you be good enough to give us your best?
DR. SCHNEIDERMAN: Thank you. First of all, thank you very much for inviting me. This is a very distinguished assemblage that I'm pleased to be part of.
What I would like to do with the first slide — and do I just say "next slide please"? Okay — Medical Futility: Where Do We Stand? What I would like to do is go step-by-step. Where do we stand in terms of the current status of the debate? Then I will point to some of the criticisms of it: where do you stand? And then I will be discussing where we have gone in terms of establishing in the medical setting with hospital policies, and finally I'll end up with what we call the standard of care, how do we achieve that if, indeed, we can.
The topic is broad. It's a classical concept, medical futility, going back as you'll see to Hippocrates . What it really focuses on is, not only our obligations as physicians and therefore as all health care professionals to our patients, what are our obligations, but what, if any, are the limits to our obligations? Then also, what is the relationship of the profession of medicine to society? Those two are the biggest elements that come under scrutiny when we're talking about medical futility.
So the next slide please. Here is an image of where we are constantly assaulted by the notion that all medical futility is, is how can we get rid of lame horses? Can you see that? Oh, I'm afraid not. That's a horse hospital. That's Gary Larson . And it shows doctors walking up and down with shotguns killing horses. And this, I submit, is the image that the opponents of medical futility have tried to promote, that all we're doing is trying to get rid of patients we don't like or we're trying to take over and assert what they always called unilateral policies, that it's the lame horses that we're going to do away with. So what I have to do is overcome that kind of image with, I hope, some rational discussion.
So the next slide. What is the status of the futility debate? Some time ago there was an editorial in the New England Journal of Medicine called "The Rise and the Fall of Medical Futility." And somebody had sat down in front of a computer and showed that, if you key-word "medical futility" over a period of about a decade, the number of citations rose and then they fell, and the conclusion was, therefore, it's no longer with us.
I and others pointed out in letters to the editor that they were looking in the wrong place, that it's hospital policies which now are the major location of considerations of medical futility as I will show you.
Everyone agrees that the problems that are raised by medical futility constitute the major cause for ethics consultations. This has been published, and it's also our experience, and wherever I go this is what people say where there is a conflict over, "Why are we doing this?" And it can be the nurses saying, "This is awful." The doctors saying, "Why do we have to do this when it makes no sense?" To the patients, "Why are they doing that?" and the families, too. So it is the major cause of requests for ethics consultations.
I think that we have to acknowledge that physiologic futility and benefit-base futility are still contested. I'll explain that.
The Society for Critical Care Medicine, although I think it's beginning to soften on this, has taken the stand that the only time you can call something "futile" is if it's physiologically impossible to do. In other words, if a patient seems exsanguinated, then you can't do cardiac resuscitation; if the patient is beheaded — I'm using their terms, by the way — then the patient is obviously dead.
This has been promoted as a value-free definition, whereas benefit-base is the one that I will try to persuade you to accept. We think that patients are what we're supposed to be taking care of in medicine and that physiologic futility focusing on organs and physiology is confusing effects with benefits, benefits being that which the patient has the capacity to say this feels good or is good or makes me more healthy. And for philosophers, it's confusing means with ends. So you will see as part of this talk I will try to explicate this.
Most of the hospitals that I deal with — I go around the country discussing this with hospitals — most of them are benefit-based. It has to do with the patient, whether the patient is benefiting from this treatment. How do we set up a hospital policy where we can say, "If we can't benefit the patient, we shouldn't be obligated to do it and, therefore, we should be thinking of something else like comfort care."
Now the next slide. Believe me, this is a slide that I had in my presentation back in 2005. I am not trying to pander to Dr. Pellegrino . But I really like his statement, and I'm going to read it. "Those who call for the abandonment of the concept have no substitute to offer. They persist in making decisions with, more or less, covert definitions. The common sense notion that a time does come for all of us when death or disability exceeds our medical powers cannot be denied. This means that some operative way of making a decision where ‘enough is enough' is necessary. It is a mark of our mortality that we shall die. For each of us some determination of futility by any other name will become a reality.”
Now what this brings to mind also is another famous Italian, who said, " Eppur si muove ." That's what this reminds me of. When Galileo was hauled before the Catholic hierarchy to recant his heliocentric notion of the universe, he was told, "We know that the Earth stays still and that it's the sun and all the other planets that rotate around the Earth." Galileo, facing what we would have probably been a pretty horrible punishment said, "Okay. I agree." And then legend has it that he said, "Eppur si muove." Still, it moves. In other words, it doesn't matter what we say here. And what I really like about this quote is that it has that same quality. It doesn't matter how much you obfuscate it. You had to acknowledge it exists. Okay?
Now the next thing is the problem with the definition. Is it a definable concept? Now the Oxford English Dictionary — and those of you who are English majors in the audience know that that's where we go for our authorities, just like in medicine we go to Goodman and Gilman — is: "Leaky, vain, failing of the desired end through intrinsic defect." It comes from the word futilis, which was a vessel used in ancient ceremonies, which was wide at the top and narrow at the bottom. You filled it up and it tipped over. You filled it up and it tipped over. It's impossible to keep it filled. Now this was a religious ceremony.
What is striking about this is that this is what has happened in medicine. We keep trying to flog patients with the same treatment over and over again because we're going through some sort of need to express reverence, love, affection. It's like a religious ceremony. And this is what we do for families. "Oh, you've got to do it again. You've got to try it again." Whereas, we can do such a better job if we can persuade them it's not by flogging patients with efforts of cardiopulmonary resuscitation but better ways to manage pain and giving them a better end of life rather than just simply the same old thing over and over again.
Next. Futility can be divided into two components, a quantitative as well as a qualitative. Now this is work by the way that I started with Al Jonsen and Nancy Jecker, both of whom are philosophers at the University of Washington . And if you go to the Hippocratic corpus, you have these kinds of statements. "Whenever the illness is too strong for the available remedies, the physician surely must not even expect that it can be overcome by medicine." "To attempt futile treatment is to display an ignorance that is allied to madness." Now, a quote attributed to Einstein this time, "If you keep doing the same thing over and over and over again and expect a different result, that's a definition of insanity." And that's why there is a kind of parallel to what the Hippocratic corpus says.
By the way, I neglected to mention that when the Catholic church insisted upon the Earth being the center of the universe and Galileo had found it not so, I consider that a very early example of socially constructed reality. Those of us who are now surrounded by postmodernism and absence of meaning or "meaning can be determined by any culture or belief," I think that was a good example of it. And Galileo — as we in medicine constantly run against what we call "brute facts" — that no matter what you call it, this is what happens.
Okay. Then I see here you're missing qualitative. It's not in the printed printout. This comes from Plato 's Republic, and it's "For those whose lives were always in a state of inner sickness. Asclepius, who as you know was a demigod, did not attempt to prescribe a regiment to make their life a prolonged misery. A life of preoccupation and illness and neglect of work isn't worth living." That last point, I will bring into contemporary circumstances. A life where you can't do anything but the life that you have, we have to ask ourselves, is that a sufficient life as part of a medical goal? Is that what medicine is supposed to provide us?
Now having said that, the next thing — and that's pretty much the status of futility in brief. I have really curtailed a lot of stuff that I would ordinarily say. But for this group, I'm trying to compress it.
The next is, what is your position of the futility debate? Oh, dear. We're missing some of the slides in the paper.
DR. HURLBUT: They're there.
DR. SCHNEIDERMAN: Are they? Then maybe I'm missing them.
DR. HURLBUT: They're on the back.
DR. SCHNEIDERMAN: Oh, clever, saving paper. I apologize. Where I come from, we only do one-sided. Okay.
What are the goals of medical treatment? Several. In the Hippocratic tradition, this is important because medicine derives today from the Hippocratic tradition, and it was really limited to restore health and alleviate suffering. The point being that the Hippocratic physician shunned the notion that he — and they were all men — had supernatural powers. That's what charlatans claim.
It wasn't until the Middle Ages and then later with the scientific revolution and the Enlightenment that people thought that, no, we can overcome nature. It wasn't just simply assisting nature that, in the case of the Middle Ages where religion played a stronger role with medicine, miracles were looked for. The so-called "sanctity of life" was begun as a notion that what doctors in conjunction with religious healers should achieve. And, of course, we all know about the Biblical miracles. This began in the Middle Ages. And the idea that — with Francis Bacon particularly being the one most associated with this — that we're now making such incredible discoveries, we may be able to overcome nature and prolong life.
Now the point I want to make is that they used the word "life," and they had a concept of life which is very different from what we can do today. Neither the late-Middle Aged theologians or the 17th Century scientists could imagine the various states of life that we're able to sustain today. I look around the room and, like me, some of you lived before the term "persistent vegetative state" was coined. This was in 1972, very recent really, in medical history.
When I was a house officer and, of course, that was in the last century, so you have to discount some of what I say, we didn't keep people alive who we could. It was very easy, a feeding tube and good nursing care. We knew that wasn't what was expected of doctors, to keep people who are permanently unconscious. That was not part of what we imagined ourselves to do. Now that's what people are doing, and we have an estimated maybe 30,000 to 40,000 patients in persistent or now permanent form of unconsciousness being maintained throughout the country.
Then that has to bring up the question, are there states of prolonged life worse than death? And I just have to point out that certainly quite a few people in Oregon think so. Even though 90 percent of the people who seek physician aid in dying are registered in hospice, they nevertheless seek to end their lives because they think that death is to be preferred to the state of life that they're in. So there is that quality that we have to mention that maybe life is not the be-all and end-all, at least from the medical perspective. Some of you, of course, will disagree.
Now moving on with quantitative futility, one of the problems as every medical student hears is: "We can never say never." Okay? That's the problem of uncertainty. So can we agree that, if we try something over and over and over again, at some point we say "This won't work." Now this goes back to David Hume and it goes to Karl Popper, both of whom were philosophers of science who said that causality is something that we conclude from our observations but can never predict. In other words, if you try A and can't get B, try A again and can't get B, and you do it over and over and over again, you cannot be absolutely certain that the next time you try A you won't get B. In other words, you can't write laws for the future. All you can do is make some kind of reasonable conclusion.
And this refers to — people get confused about that quantitative notion — we said in our paper, and I don't know if you read any of the papers that I put in there. But we said, you have to pick a number. You can't just say, "Oh, zero survivors," because you have to have some mathematical way to calculate. Can we say within a certain degree of probability that there are no survivors, and this is what we use to do statistical tests for. And we've adopted one, the 1 in 100 rule, because that's the classic one that's used for P value of .01. This is statistics. It's reasonable. By the way, in a court of law, a jury can sentence a convicted felon to death if he's a murderer, say, not when they are persuaded beyond all doubt, but beyond a reasonable doubt. We recognize this is a term of art in our human experience. You cannot be absolutely certain.
Now those of you who recall Linda Emanuel — I read she said this is not very helpful to her. So if you will notice at the bottom of that slide, it just so happens within the last month a very important paper was published giving the outlines of when the indications and guidelines for attempting CPR in the outpatient setting. And they say the "basic life support" rule had a positive predictor value for predicting lack of survival which is"within the acceptable range used by medical ethicists for defining futility." I'll bet you can guess who those ethicists were who were defining futility. They were referring to our original paper.
So in other words, the early American Heart Association guidelines said things like, "Oh, you've got to resuscitate unless the patient is dead or there are zero survivors." Well, again, we, again pointed out in the paper, you can't say zero without telling me. How many times are you going to try before you conclude there are zero survivors?
Okay, so next: Quantitative, Or Else. Now I'm quoting here a paper by Rubenfeld and Crawford. These are researchers at the University of Washington that has a superb bone marrow transplant program, which has a large experience. And one day these two very fine young men decided they would go over their past experience with bone marrow transplantation. And since Crawford, in particular, was a pulmonary specialist, they wanted to find out of all those patients they put on a ventilator, what was the outcome? And to their horror, they discovered that they found that 398 patients who had, what we call, "multi-organ failure," had been put on a ventilator. Zero survived.
And I find it rather plaintive, their conclusion, which I have here which I'll read." It is difficult to specify limits beyond which treatment should be withheld when there is any chance that a life can be saved. However, if we cannot agree that treating 400 patients with prolonged intensive care without producing a single survivor is beyond such a limit, then it is unlikely we can reach a consensus about limiting care in any clinical situation."
I have to point out that, although I applaud these folks for looking back — and by the way, they now use this as a caution and don't put people on a ventilator under these circumstances — but if they had looked sooner, after 100 patients, they would have spared nearly 300 patients what is a very burdensome tortuous procedure which is futile. In other words, the patients didn't survive after rib-breaking, heart-shocking, tube placement in patients who were dying in the ICU. That's pretty rough stuff, and they did it to 300 patients. Had they stopped it at 100, they would have spared them that kind of torture.
Okay, qualitative. Next, I just want to touch on the qualitative. The goal of medicine in my opinion and the opinion now of many others is not really to provide an effect but a benefit which can be appreciated by the patient. Therefore, we think a treatment is futile if the patient remains in a permanent vegetative state. There is biological survival without conscious autonomy. The patient cannot feel anything, express anything, do anything with the life that's been given him or her. Or, in our original proposal, we said if the patient can't survive outside of the ICU that person is "preoccupied," according to Platonic concept, with his illness and the treatment, therefore, if that's the best you can do, that treatment is futile. Since then, because many of the outcome studies have to do with hospital discharge, we've expanded that simply. So it's not only the ICU but the acute-care hospital.
Our job as physicians is to give the patient enough — and that may be minimal — but to give enough help so they can go out in the world and interact and do something with that degree of health that they have. Short of that, we are not doing our job. We are simply keeping a body alive using technology that was intended for other purposes.
Okay, so now we get to: What is your position on the futility debate? And I'm going to pose a series of questions and my response. But you will have an opportunity, I'm going to assume, to respond to those.
Isn't futility a value-laden term and shouldn't only a value-free or strict physiologic definition be used? I've already given you my thoughts on that, but here we go. Physiologic futility is not value-free but a value choice, which departs dramatically from the patient-centered goals of medicine. That's one thing. And by the way, physiologic futility, even though it's supposed to be value-free has been contested. And the New York State Task Force's version of it was challenged by those people in critical care medicine.
But more important, I think, for what the consequence of that idea — and this is because medicine has been so dominated by subspecialists in the basic sciences — they lost their way. They lost the sense of the whole. And what this has resulted in is that delayed medicine's appreciation of the importance of good end-of-life care.
We are just now getting around in the last few years to requiring doctors to know about pain medicine. Palliative care or palliative services that are just beginning to appear. This is shocking that medicine has gone on this long and neglected something this important. We all die, and we all die — remember, 80 percent of Americans die in a health care setting, 60 percent in an acute care hospital.
How patients die, not whether they die, but how they die depends on a lot of what doctors do. And to my mind, it's shocking that we are just learning to come to this as a result of getting away from that notion of physiologic measurements. We are not experimental physiologists. We are physicians.
Okay. Doesn't a patient have a right to obtain any desired treatment? This is a claim that antagonizes and opposes the notion that physicians can, and they use the word "unilaterally," although as I will explain we go through great efforts to achieve a consensus. But I had a patient once, a very well-developed and muscular young woman who came to me and said she wanted to be a world-class body builder and she asked me to prescribe anabolic steroids. Well, I'm licensed to provide anabolic steroids. Anabolic steroids can certainly bulk up her muscles, but I couldn't prescribe it. I didn't prescribe it. It's illegal, which is society's way of saying, "No." But I just wanted to dismiss this notion. She has her personal goals which were not compatible with medical goals. This is what we have to keep in mind. Sometimes patients want something that is not something that medicine should be obligated to provide, and that is the source of the disagreements very often in futility.
Next. How can the physician be absolutely certain a treatment won't work and produce a miracle? As I've already indicated, we can never be absolutely certain, only reasonably certain. And again I use that term of art from the law. Is the physician obligated to seek a miracle? What I'm always saying is in the old days when patients wanted a miracle they went to church and prayed to God. Now they go into the hospital and demand it of the doctor, though we can't provide miracles. In my books and writings, I cite instances in the Bible where they clearly say physicians are not empowered to produce miracles. And so we have to get away from that notion.
What if the patient or more usually the family insist on doing everything even if there is only 1 in 100 chance of it working? As I always point out when somebody says to me, "Oh, you should do it even if it has 1 in 100 or 1 in 1,000," remember the denominator. What you're saying is this might work after you've done it 100 times. But 99 times it's going to fail. And we're talking about failure at the end of life when patients in the ICU are getting attempted CPR or getting ventilator treatments or being really manhandled and woman-handled in a very aggressive way. This is harsh stuff. This violates the notion of proportionality. So remember the denominator if you really are going to literally make that argument.
Okay. And then — Isn't it true that no standard of care has been achieved with regard to medical futility? I'm going to, I think, respond to that and it's clear, hospital policies and statutes are developing a majority and respectable minority standard of care. Just to kind of give some forecast to what I'm going to say, I think we can deal with a conflict which is going to be interminable by making this kind of accommodation, and I'll go into more details.
Okay. A few exceptions and cautions. People say, "Well, if I'm not going to do the treatment, do I have to even talk to the patient about it?" And then there have been critics who say, "See, they want to deny the treatment and they won't even tell the patient they're not going to do the treatment." I think it's context dependent. When I was taking care of patients who had a headache and it was an obvious tension headache, I didn't tell them, "Oh, you know what? I'm not going to look for a brain tumor. I'm not going to do a CAT scan. I'm not going to call the neurosurgeon," because in that setting, the context didn't require it.
Anyone in the ICU though, anyone who has watched television, knows that one of the possible treatments is attempted CPR. I keep using the word "attempted," I hope you will notice. Our term is not DNR. It's DNAR. Do Not Attempt Resuscitation. It's called truth in advertising. In other words, it doesn't work very often despite what you see on television.
In any event, anyone in the ICU — and it's our rule that if you are going to say we will not attempt it, we will write a DNAR order on this patient for the following reason, and we will discuss it or have discussed it with the family usually, but that's obligatory. You do have to discuss it and explain it.
The other thing is people think that just because you declare a treatment futile that we're going to be really nasty and rough about it and just pull the plug. That doesn't happen. I mean, we make what's called a reasonable accommodation. This, too, is a term of art from the law. The first time I read of it was when the Long Island Jewish Hospital had a patient, an Orthodox Jewish family, their daughter was dead by whole-brain criteria. The Orthodox Jewish family didn't accept that. They insisted that — and notice I'm not going to say "life support," which is what The New York Times said — the patient was dead, remember — but "organ support." They maintained organ support for two weeks saying, "We'll try to accommodate this family." After that period of time, they said, "This doesn't make sense. This is a dead body. This is not a patient. We're not obligated to continue this," went to court, and were in fact permitted to withdraw the organ support from this patient.
The decision said that the hospital had made a "reasonable accommodation." We call it also a "compassionate exception." If I have a patient that I'm rounding on and the patient is a woman with metastatic cancer, she's bedfast, we know empirically that if she has a cardiac arrest she has no realistic chance of survival and a hospital discharge, and she says, "My son is in Iraq . They've notified him. He's flying home. Can you keep me alive or, if I have a cardiac arrest, could you try to keep me alive until he comes home," the answer is yes. Even though we know it's futile, we will do what we call the "compassionate exception."
Now Sue Rubin refers to Imbus and Zawacki, who looked at patients who had severe third-degree burns. This is a very fine paper where these burn specialists offered to patients a chance to continue treatment or not, aggressive treatment, knowing that their chance of survival was nil. They gave them that option. Some patients said, "Yes, keep me alive as long as possible," even though they died anyway. Others said, "No, I accept your decision and I would like comfort care."
This is a compassionate exception. This is what we do in medicine. This is different from what Terri Schiavo's parents asked for. This is something that lasts a few days, at most a few weeks. The difference is that we should not as physicians be obligated to continue the life of someone who is permanently unconscious, gets no perceived benefit for years. And that's where we draw the line.
Okay, Further Implications: Once a treatment is shown to be futile, it should no longer be offered except as an experimental trial requiring human subject approval and patient informed consent. I usually use this on the oncologists. The oncologists are always attempting CPR. And on one of my rounds in the cancer center, every single patient there with metastatic cancer was full code. And they think, "I have to do attempted CPR." The evidence is that it will not benefit the patient in terms of getting them out of the hospital. So my recommendation now is, "If you oncologists think that your patient is different or your technique is better or there's some reason why you think attempting CPR on this patient is going to result in a different outcome than all the others, that's an experiment. Use your experimental informed consent, not treatment informed consent. You should submit this protocol to the IRB." In other words, what we're doing is trying to improve medicine rather than just flog the same thing over and over again that doesn't work.
And — "Patients do not have a right to unproven treatments on the grounds that their disease is serious and no treatment of proven benefit is available." During the heyday of AIDS activists, this was the argument used. "Oh, these people are going to die. They deserve anything they want." And some of the stuff they got was more toxic than the disease itself.
Let me point out something that's not appreciated, I don't think. "Big Pharma," by their own calculations, point out that for every 5,000 new chemicals that are synthesized, 250 make it to animal trials, 5 make it to human trials, 1 gets ultimate approval by the FDA. At every step, the majority are rejected because either they are useless or harmful. So this notion that before we really go through the Phase III and go to clinical trials that a treatment is "promising" or likely to benefit is wrong. It's more likely not to benefit and even to harm.
Okay. Now we move on to the hospital policy, and here is the UCSD Medical Center policy. This was put together by a committee, as you can see by how verbose it is, and it's one that is now being a model that we're working on for the San Diego community.
If you don't mind, I'll read it, the definition of futility, "Futile treatment: Any treatment without a realistic chance of providing an effect that the patient would ever have the capacity to appreciate as a benefit, such as merely preserving the physiologic functions of a permanently unconsciousness patient or has no realistic chance of achieving the medical goal of returning the patient to a level of health that permits survival outside the acute care setting of UCSD Medical Center." We could only speak for ourselves. Okay, that's the definition. Now we quickly go on, and it's, "In the event of disagreement among the parties involved in the treatment of a patient, futility will not be invoked before the completion of an appropriate dispute resolution process."
Now I want to say a couple of things about dispute resolution. There are some people who make the argument that there is no such thing as futility. Everything will be resolved by a dispute resolution, kindness, by listening to the patient, intensive communication. Actually, I have to credit Thaddeus Pope in his presentation the last time. He admitted that it doesn't always work. Also, I was asked as a consultant by an outside hospital to deal with a very intractable situation where the wife absolutely refused to allow her permanently unconscious husband to be given a peaceful sendoff. She became so terrifying to the nurses that some of them quit. She threatened the hospital with all sorts of mayhem in the news. And they hired a professional mediator who accomplished nothing.
The thing that you have to understand about mediation or dispute resolution is it comes from the fields of the law and business where compromise is the most sensible thing to do. If you and I disagree about a contract where we're both after the same million dollars, we may decide, "All right then. Let's split the difference and not pay the lawyers." That's the kind of compromise that you get in the business and law area. It's not that way in medicine. People are either dead or they're not. And so you'll get intractable, insoluble situations even after all your best efforts.
Now, there is also the question of the hidden agendas. Some of you know the Helga Wanglie case. This is a woman who lived in Minnesota who was permanently unconscious. It was one of the first to become public. It wasn't quite a futility situation, but the health care workers there had two patients who were permanently unconscious. One was on welfare, and the other one was Helga Wanglie who had private health insurance. They didn't want to get into a dispute with the courts about the welfare patient because they didn't want that to be tainting their whole consideration. It turns out that the family which insisted that doctors shouldn't play God and had very high lofty moral explanations for the behavior — in fact, their pension depended on how long Helga Wanglie would live. They insisted that the patient be in the hospital because if she went to a nursing home then she would only be eligible for Medicaid after they spent down their assets. There are so many other factors that go in that are non-medical that tainted the views in some of the landmark cases.
I should point out that — oh, by the way, this case that I just described is published in the Hastings Report. And I asked Nancy Dubler, who is sort of the world expert on mediation — she's written a book on it, she's one of the advocates of it. I said to the editor, "Look. We'll write our position on this and get Nancy Dubler to write hers." By the way, you can only make peace with your enemies, and so I'm always looking for people who disagree with me, as you'll see today. This is where we try to deal with that issue.
Now following right away after our definition of futility is this next step, which is "comfort care" — "Care whose intent is to relieve suffering and provide for the patient's comfort and dignity. It may include analgesics, narcotics, tranquilizers, local nursing measures, and other treatments including psychological and spiritual counseling. It should be emphasized that although a particular treatment may be futile, palliative or comfort care is never futile."
Whenever I hear anybody use the term "futile" care, I know they haven't thought deeply about this. "Care" is a word that we treasure for our patients. We never say there is no care possible, that this is futile care. Each treatment is evaluated on its own terms whether it benefits a patient. Care is never futile.
Okay. The next step is — What is the standard of care regarding medical futility? And here is a quote by George Annas that I like almost as much as Dr. Pellegrino's. "Physicians must...not only set standards for medical practice, but also follow them. Physicians cannot expect parents, trial-court judges, insurance companies, or government regulators to take practice standards more seriously than they do themselves."
You've got this after the Baby K case. The Baby K case, as some of you know, is a baby born with anencephaly. That's where the brain is completely gone at birth except for the brainstem. So although the baby has all of the so-called vegetative functions — the heartbeat, respiration, digestion — and can survive, there is absolutely no awareness there in any other respect. A person can't hear, understand, see, and that person will never grow up to be what we have associated with a living person. This Baby K case, though, was one of the serious cases that we had to confront in medicine. The hospital asked the court for permission to withdraw life-sustaining treatment, and they were denied that as I'll explain. But this is a mistake that hospitals make. They go to the courts for permission. Massachusetts General Hospital didn't make this. One of the best cases to actually define the limits of medicine. It was the Carol Gilgunn case where after months and months of efforts to accommodate the daughter's wishes to keep her mother alive, it went to a jury trial. The daughter said, "My mother would have wanted to be kept alive." The jury said, "Yep, she's probably right. She's speaking of what her mother probably said." On the other hand, the jury said, "Doctors shouldn't be keeping people like this alive indefinitely." So this is what I call one of the instances where the public is speaking, and it's clear that they understand this.
Okay. There are a few ways to go at this standard of care which are legislative. I'll just briefly go by them. You know about the Texas Advance Directives Act, and that Thaddeus Pope gave it to you. I'm just emphasizing that it is 48 hours notice and, if there is no resolution in 10 days, that the family has a chance to seek another hospital and, if they decide then to withdraw futile treatment, then they have legal immunity. This Texas Advance Directives Act has been attacked as discriminating against minorities and this is wrong, and people have been using claims and statements that have been unverified.
The next slide should be by Larry McCullough . He really got angry. I don't know if you know Larry McCullough. He's an outstanding ethicist, one of the old-timers. And he's a very sober man. But he really got exercised by the way medical ethicists, including others, had distorted what was going on. And he says here, "Any claim about racial or ethnic characteristics of patients brought for review under the Texas Advance Directives Act lacks a foundation in fact. Colleagues should be aware that some statements by family members, including statements to committees of the Texas Legislature and to the press, lack foundation in fact. That bioethicists add their own groundless and potentially explosive speculation to the public debate is irresponsible on its face and constitutes a disgrace to our field." I've never heard him get that exercised.
Okay. Here's another way that I personally have tried to see what we can do about establishing a standard of care. Back in 1998, I called together a bunch of hospitals up and down California and members of ethics committees. And you can see what I was hoping is that we would look at the hospital policies of a variety of hospitals who actually had tried to address this issue of medical futility, give them some cases, and see how those cases would be resolved with their policies.
Now I did another thing, which again I'll tell you, I asked Alex Capron who is a professor of law at USC to co-chair the conference with me. He is an outspoken opponent of medical futility. I just wanted to make sure that we were, in the much maligned phrase, fair and balanced.
Here's a summary. We had 74 participants — that's all that could fit in the room — 53 ethics committee members; 29 hospital ethicists. You can see that we had physicians, we had attorneys, we had judges, and we had laypersons and members of the clergy and nurses. This was a room about this big where we all would try to deal with this issue.
Now here's what we came up with. All but 2 of 26 hospitals had specific futility policies that define nonobligatory treatment. By the way, these are in hospitals that were doing it independently. We didn't have a consortium. We didn't have many, many, many meetings. This is what I brought together, and let's see where we are. All but 2 of 24 hospitals defined nonobligatory treatment in terms of benefit to the patient rather than physiology, some with specific examples, dependence on ICU. So they were obviously influenced by our paper. But I want to make it clear, that's why I am confident that the majority standard is benefit-based and not physiologically-based. This provides a basis for definitional standard that justifies a futility decision, and for a respectable minority.
So the next slide. Here is where I think we should go with medical futility, considering the fact that not everyone will agree with the majority standard.
Oh, by the way, I was very disappointed at that meeting because we didn't all agree. And I said, "How can we have a standard of care if everyone doesn't agree?" Alex Capron, it was he who said, "You know what? You don't need everyone to agree. You have clearly a majority standard. And in the law, if more than one person follows a procedure, that can be a respectable minority."
So here's what I'm saying. The majority standard: Medical futility refers to treatments that offer no realistic quantitative or qualitative benefits to the patient. If this is your standard, document it in your institutional policy and provide procedures for dispute resolution, declare this policy as your professional standard of care for the information of the public and as a guideline to the courts.
Now if you are a minority, then this imposes certain unexpected requirements on you, I think. If you have an alternative definition or no documented limit on treatment, declare this policy as your professional standard of care for the information of the public and as a guideline to the courts — and here's where you say what you really believe — accept transferred patients and avoid court disputes. In other words, if you really say, we believe in keeping these people alive, then you have to say, if you are rejecting this patient, we will take him.
We already have different kinds of hospitals. We have some hospitals that do abortions and some that don't. We have some hospitals that do bloodless surgery and some that don't for Jehovah 's Witnesses. So this is not a big deal. This is an acknowledgement that there are different values. I accept that. We made our case. We think the majority of hospitals are following this and an increasing number are. But those who don't should see their responsibility of either — is this your position, or are you just talking?
Okay. Finally, not quite finally, I just want to make this point, which I've already made. What is the standard of care? Ask permission of the court to discontinue life sustaining treatment? — this is important — No. Withdraw life-sustaining treatment according to hospital policy and defend [the action]? Yes.
Let me point out that at UCSD — and, in fact, I learned just before coming here in all University of California hospitals — there has never been a single court case where we have invoked our futility policy and lost or had any difficulty with it. You go through the steps, and the courts support the physician. And I see it happen over and over again. Doctors are very paranoid. There is only one doctor who has ever been put in prison for deliberately killing a patient and you all know who that is — Dr. Kevorkian . And he had to go through at least a half a dozen jury trials before anyone would convict him. And he finally had to do it on TV before they got him. The public really understands that there are things that doctors shouldn't be doing and want to support that.
Now, finally, okay. I started thinking: Those of us who recognize the importance of the limits of our obligations to continue aggressive life-sustaining treatment are very much involved in how do we make good palliative medicine, bringing in family, long discussions. In other words, one of the things that Dr. Truog in his article says in the Gonzales case that he thinks that folks like that, that their wishes should be honored and tolerated. He didn't say "obeyed," and I think that what we do in our hospices and by lengthy dispute resolution and by many meetings of ethics committees for patients who refuse to accept the inevitable, we are doing that to honor their wishes. It's just at the end, we don't obey them. And Bob Truog and I might agree you go very far, but you don't necessarily obey.
Okay — A Good Death Then. I don't know how many of you know Willa Cather 's book, Death Comes for the Archbishop . But she describes this ideal scene that was before our high technology. This was death in the 19th Century. "In those days, death had a solemn..." well, actually, do you need me to read that? Why don't you read it because it's such a lovely passage? And then when you're done, I'll read the next one because it's short.
[Insert passage from slid]
A Good Death Then
“In those days…death had a solemn social importance. It was not regarded as a moment when certain bodily organs ceased to function, but as a dramatic climax, a moment when the soul made its entrance into the next world, passing in full consciousness through a lowly door to an unimaginable scene. Among the watchers there was always the hope that the dying man might reveal something of what he alone could see…the dying murmurs of every common man and woman were listened for and treasured by their neighbours and kinsfolk…and pondered by those who must one day go the same road.”
From: Death Comes to the Archbishop, Willa Cather (1927)
[End of insert]
What we are doing in medicine is seeking to balance the electrolytes in a dying patient, preventing what almost certainly happens which is metabolic acidosis and dehydration. These probably account for some of the euphoria in the dying patient. In other words, we, in our modern technology, have made it hard for nature to do a good job of giving patients a good death.
Now here's what happened. This was a little article in The New York Times that I picked up. I'm trying to say, what is a good example of a good death now? And it happened to be Washoe, the chimp. And Washoe, the chimp, apparently was a very remarkable chimp who learned lots of words. And here's the description:"'The chimp died in bed at age 42, surrounded by staff members and other primates who had been close to her,' Dr. Jensvold said." And I thought, goodness, if we can do that for a chimp, why can't we do that for people?
And the final slide, and this is the final slide. Remember, I told you about the Baby K case, the anencephalic. The New York Times reported this in this particular headline, "Court Order to Treat Baby Prompts a Debate on Ethics." What concerns me is the subhead, "At what point does treatment cease to be worth the expense?" Notice how it's the cost, nothing else that seems to matter, that this has become the issue — should we be paying money for this? This concerns me because the main impression that's been looked at is, if we pay them, they will do it. That gets us close to being a version of the oldest profession. If you pay me, I'll do anything you want.
Now it just so happens I've had patients who were members of the oldest profession and they assured me there are some things they wouldn't do no matter how much they were paid. And I think it's important that the medical profession achieve such high standards, too. Thank you.
CHAIRMAN PELLEGRINO: Thank you very much, Dr. Schneiderman . I've asked Dr. William Hurlbut, a member of the Council, to open the Council discussion. Bill ?
DR. HURLBUT: Thank you very much. Both in the readings and in your presentation I felt an echo of what meant so much to me in my medical training; namely, the perspectives, insights, and comprehensive wisdom that come with really living as an earnest physician trying to truly benefit patients and realizing that what may be the initial reaction to a situation isn't necessarily the most profound and comprehensive good, but that slowly but surely really living within the realms of final suffering and death one starts to see and make sense of what is termed on the one hand ethical and, on the other hand, just good for human beings. I mean, the common sense notion here is central to what you've said, I believe. But it's not just common sense in the easy impulsive immediate sense. It's in the comprehensive sense of seeing what it means to die.
I thought your comment at the end about the possibility that our technology is interfering with that, some potential benefit of the natural euphoria of imbalance of electrolytes, that's a fascinating comment. You have to wonder if we're missing some points.
But reflecting on your paper before your presentation, it struck me that so central to your general perspective is the notion that there are goals of medicine, that these are, at first, goals refined by those who encounter the realities, and somehow they make their way out into a general endorsement by the society.
And I just thought that one thing you could help us with a little bit here is, could you just say a couple of words about the strange struggle we seem to be entering in with our society trying to balance between extreme measures against which futility is a notion that precludes those extremes and a growing sense that — notwithstanding what you said about the public understands that there are some things that doctors shouldn't be doing — that we just witnessed the passage of a bill in Washington state to allow euthanasia, so-called euthanasia or active physician-assisted suicide.
DR. SCHNEIDERMAN: Yes.
DR. HURLBUT: Could you just say a little word about that and then just say a little bit more about how you think the goals of medicine become clarified?
DR. SCHNEIDERMAN: Do you want me to respond?
CHAIRMAN PELLEGRINO: Yes.
DR. SCHNEIDERMAN: Okay, thank you. Just to begin, the idea that standards, just as Dr. Hurlbut said, begin with the profession and then the profession proposes and then society disposes, and George Annas said the same thing.
I remind you that the Kansas School Board at one point was told by the public that they should endorse teaching creationism as a science alongside evolution. And you can bet that the majority of the public wanted creationism, believe in creationism. I think 40 percent of the public overall and probably a lot more in Kansas . The Kansas School Board said, "No. Our professional standards are we do not teach creationism as a science."
That's one way that medicine says, "Here is what we believe doctors should do, and we've got a history starting with Hippocrates," and, by the way, I just read another biography of Osler when Osler had this same notion of what doctors should be doing. We have a long tradition of this is what constitutes good medical practice, and we're not dispensers of the supermarket that we give whatever the public wants.
So I think we are achieving that. In California, what I kind of went over very quickly, just last month the California Medical Association endorsed this notion — which you can see in part on one of the slides — that physicians should not be obligated to do things which violate the general standard of care even though the patients insist upon them, that there is a limit to the obligations just as there are obligations: EMTALA, the Emergency Medical Treatment and Active Labor Act; I talked about the Baby K who was brought in recurrently with respiratory failure. And by the way, this is one of the faults that I had with the folks, the lawyers, who wrote the brief for the American Pediatrics Society that you might be interested in. They kept referring to Baby K, who could feel nothing, as "suffering" from respiratory distress. It seems to me that — and I later talked to judges about this — and, yes, they felt "distressed" meant she was "feeling pain." She wasn't in respiratory distress, she was in respiratory failure.
But what was happening then is that this was an infant brought into the emergency room and required ventilation. The Act that was being cited was a very important act, the Emergency Medical Treatment and Active Labor Act, also called the "anti-dumping" act. What was happening is that emergency rooms were taking patients who couldn't afford to pay, putting them in a car or an ambulance and shipping them off somewhere else and the patients often died. And the federal government said enough of that, and we have this federal statute. This is what was applied to Baby K.
Now I have to admit I was one of many who were very upset that, my goodness, this is not what they were thinking. Later the same Fourth Circuit Court which ruled in the first case in Brian versus Rectors said, "We're just talking about the emergency room. If patients go into the emergency room, you do what it takes to stabilize the patient." And I give this counsel, too. "If a patient comes into the emergency room and you don't know that patient, if you looked in past records that say no or if it's not likely or is likely that this patient will survive, you treat. You can always stop later."
And so the point is, an emergency room is a very special place where you go for it, and this kind of interaction between the profession which states its standards, the public which accepts them very usually — I mean, the huge outcry to the Terri Schiavo incident to me makes it quite clear that the public is on our side saying there are certain things that shouldn't be done. If somebody wants to do that, then let them have their own special location for doing it. But that's definitely a minority.
The interaction between the court, the professional standards, and what the public thinks when events happen, I think that this is slowly progressing. I personally think that things are happening. I mean, more and more hospitals are developing futility policies. Our experience is that they work. And we're distinguishing this from rationing, by the way, which is another big topic. I am not talking about rationing.
The difference as I see it, futility, whether it's cheap or expensive, should not be used because it doesn't work. Rationing should be applied only to therapies which do work — medicine allocation problems, heart transplant — it works. If we don't have enough hearts, that's a serious problem. How do we allocate? But heart transplants in somebody who is permanently unconscious, that's not a rationing problem. That's a futility problem because that patient would not benefit from the heart transplant.
I don't know if that answers you or not.
CHAIRMAN PELLEGRINO: Thank you very much. We will now begin the general Council discussion. I have Dr. Meilaender first on our list and then Dr. Dresser .
PROF. MEILAENDER: Thanks very much. The presentation was interesting. It raised a lot of questions for me, but I'll only ask one though I do have to say that I think we live in different publics, actually, because the public you described is not the public that I know.
But let me just ask you this question. You say that medical treatment may be futile, but comfort care is never futile. What I'd like to know is how you know that comfort care is never futile?
DR. SCHNEIDERMAN: Well, it goes along with my notion that there is always something you can do to care for a patient, to comfort a patient.
PROF. MEILAENDER: But, to use your own language, there may be patients who lack the capacity to appreciate it.
DR. SCHNEIDERMAN: Well, in those circumstances, then comfort care is not applicable. I mean, comfort care —
PROF. MEILAENDER: So there are patients that you just wouldn't be able to give comfort care to?
DR. SCHNEIDERMAN: Probably. If a patient is permanently unconscious, can experience nothing, we talk of comfort care as I defined it with dignity. And there is where we say — just like a dead body. A dead body can't appreciate what's being done to it, but all of us recognize that you treat dead bodies with dignity. And I would put it in that same notion. Comfort care though is for anybody who has any sapience, any capacity —
PROF. MEILAENDER: Well, would you turn the body frequently? That patient with no capacity to experience, would you turn the body to keep it from getting bedsores and so forth?
DR. SCHNEIDERMAN: Well, first of all, you're talking about a permanently unconscious patient?
PROF. MEILAENDER: Sure. That's my example.
DR. SCHNEIDERMAN: Yeah. I would discontinue life-sustaining treatment. So that wouldn't be an issue. In other words, what we know now is — and this is what hospice has taught us — if you force-feed — which is what you're doing with artificial nutrition and hydration — patients are either terminally ill and usually in a permanent unconsciousness, their bodies are incapable of handling the fluids that you put in. Unfortunately, I've seen instances —
PROF. MEILAENDER: But that's clearly not your patients in persistent vegetative states.
DR. SCHNEIDERMAN: Yes. It is, too.
PROF. MEILAENDER: I mean, they have lived for decades.
DR. SCHNEIDERMAN: They do. You can. That's good nursing care. Look, if that's your desire, to keep a permanent vegetative patient alive, as I said, it doesn't take much, a feeding tube and good nursing care, if that's your goal.
PROF. MEILAENDER: I'm not worried about my desire to. I'm worried about the definition of "futile." How do you know that that's never futile for such patients?
DR. SCHNEIDERMAN: Well, okay. It's the way we define it. You can accept it or not, as I say. We believe that the patient will never have the capacity to appreciate the effect, whether it's raising the blood pressure or treating the metabolic imbalance or treating infection or treating real things. If the patient will never experience a benefit from that, we call it futile.
You might say, "Oh, heck. I don't call it futile because this patient may be permanently unconscious but I'm fixing the kidneys to keep him going." That's physiologic futility. I disagree with that. But if there are those who want to keep people like that alive, I've already said that's a respectable alternative.
PROF. MEILAENDER: Let me try just once more. How about the severely demented patient and comfort care? How would you know that it's never futile?
DR. SCHNEIDERMAN: Okay. You're getting now to, how do we know that's — what is the term? How do we know what we know? This gets even worse with a minimal conscious state. There's a well-known case in California, the Wendland case, where Mr. Wendland kept pulling out his feeding tube and was apparently very angry at anything that was done to him when he couldn't speak in a way that we could understand what he really felt. The same is true of demented patients. And there I will accept that there are different views of this. There are folks who say our story that we construct now is that we will have a life that we would like to end in a certain way, with dignity and loving our friends being around, recognizing, and that's the life we would like to have.
Some of us will not have that. We will then get severely demented, and we will sit in front of a television set and smile. And there are people who say, what's wrong with that? And I will accept that, although I personally have executed a durable power of attorney so that I will not be maintained that way. In other words, we have choices about our life. And I think doctors can do something about it.
I'm not sure I understand why you are having problems with the futility when I'm trying to say, here's the way we define it. If you choose to define it another way, then you have certain consequences that go along with that.
PROF. MEILAENDER: I'm not worried about different definitions. I'm worried about incoherence in your definition.
DR. SCHNEIDERMAN: The incoherence? I'm afraid I don't understand where it's incoherent.
DR. FOSTER: Well, I wonder if I could comment. It seems to me that the comfort care that you're largely talking about would be in the situation of, let's say, hospice care for somebody who has cancer and so forth, and it doesn't have anything to do with the prolonged care of an unconscious patient. So I think that almost every physician would say that comfort care in the hospice situation is what all of us would want and want to do.
And Gil is asking, I think, a longer question. So I think that he's addressing a question that you are not addressing in terms of comfort care in the normal, if somebody doesn't — lots of people don't die in the six months of hospice care, but you still try to keep them from suffering if there is a way to do that.
CHAIRMAN PELLEGRINO: Thank you, Dan . We have three Council members already asking to comment. So I'd like to ask Prof. Dresser first.
PROF. DRESSER: Thank you. I have a couple of questions. One was, I was interested in your paper and presentation where you said, "Many hospitals have policies that would say continued treatment of patients who are permanently unconscious is futile." So I wondered — and then on the other hand, as you say, we have 30,000 or 40,000 people existing in that state.
My impression is that many families want that continued, and I'm not so sure what the public thinks about the case where when you don't have an advanced directive asking for treatment to be stopped and the family wants it to continue what they think of that view versus the Schiavo case where there was some evidence that she would want treatment stopped.
In any event, does this mean that hospitals are discontinuing treatment in cases of patients who are permanently unconscious against the wishes of the family based on a hospital policy? Is this happening a lot? I just haven't heard that it is.
Can I ask one other question?
DR. SCHNEIDERMAN: Sure.
PROF. DRESSER: The other one is, given that some of this is based on a values conflict, probably one of the strong examples is the patient in PVS. If the goal is to reduce the number of cases in which futile treatment is given by your definition, would it be more productive to focus on the physicians who often are the ones who are responsible in a sense for continuing this kind of treatment, either because they don't want to raise the issue, they don't want to give up, whatever, focus on that audience and less so on the cases such as in Texas where you have the family expressing a values choice, disadvantaged. It seemed as so everybody is ganging up on this poor family.
So I guess my question is, why not focus on the medical profession's contributions to futile treatment and try to address these unusual cases of family opposition in a more, as you put it, compassionate way?
DR. SCHNEIDERMAN: Thank you. Let me address the first one, do hospitals every now and then discontinue life-sustaining treatment for permanently unconscious patients? The answer is, yes; against a family's wishes, rarely, because it rarely happens.
In other words, people are constantly talking about how mediation and intensive communication and all of this is so important. We agree, and we do it, and it often works. It doesn't always work. But the consequences of it not working without having — the house staff that I work with are really glad they have this futility policy because it used to be that people would feel very helpless and upset. They want this and it makes no sense, and I have to do it and what's the point. And then you know the term "moral distress." The nurse is obviously the one who suffers along with the patient while all this is happening.
They have this futility policy and now I can talk to them and say, our duty now is to help the family cope with the patient's death and grief. Well, how do we do that? Well, how do we do a better job of communicating how we care about the patient? And we have a whole line that we say. You know, "You obviously love your mother and spent a lot of hard times working with her. We did, too. And now we all have to start thinking of a better way to treat your mother than just to do this." In other words, we really try to work with the family and they usually do decide to come along. When they don't, we have done it. And the paper that is the multi-center randomized control trial of ethics consultation in the ICU will notice that about, I think, something like a half a dozen families and doctors were unhappy with the outcome.
And if you want to look that paper up, it's in the Cambridge Quarterly and it has the title. It came out after that paper, so it won't be cited in that paper. I'm giving you the citation. And it's called the "Anna Karenina" Principle: "All Happy Families are Alike. Unhappy Families Are Unhappy, Each in Its Own Way." We did find families that were unhappy. We found doctors who were unhappy, nurses. We explored that because I really wanted to see, not only where we succeeded, but where we didn't succeed. And it turns out that the families were disappointed that the ethics consultant didn't spend more time with the family at the conclusion of the ethics consultation. And so we realized this, we'd become really bonded to the family and so, therefore, we owed them that much, not just, here's help, goodbye.
The other thing is, they didn't like the fact that the patient died. They couldn't accept that. Now, there's nothing we could do about that. But I have to emphasize, if you read the paper, they said that they still liked the ethics consultation. Why? Because they were heard. They said, "Even though we didn't like the outcome, we felt that they did what they could to hear our objections, our concerns."
That is, I think — again, I don't want to brag about this, but we've done it. And if we do it the right way, we've not been sued. And that's what doctors — and that's why doctors are doing it, by the way. You asked, how come doctors are doing this? They are very paranoid.
In every case including the Barber case in California, which established the logic for removing a life-sustaining treatment which you had already started, which made a point of the difference between effect on the body part and the benefit to the patient, which gave us very strong grounding for these kind of decisions. When doctors who know about that case, all they know is that a doctor was sued, was on trial, they thought, for murder. And that's all they want to know is that they never want to have any part of that. So that's part of the problem.
Did I answer all your questions? I mean — oh, and, yeah, we are working on doctors. I mean, I do this all the time. And we have medical meetings, ground rounds. I have to also emphasize that everyone talks about the power of physicians over patients and families. One of the reasons why we think there should be a definition and not just a dispute resolution policy which is what the Houston Consensus has — they just give you a lot of steps — the problem is, we've seen families who have power. They know if they call their local TV station, it will scare the docs and the hospitals particularly. So it's not just doctors who are invoking power in these matters.
CHAIRMAN PELLEGRINO: Thank you, Dr. Schneiderman . Can I alter the procedure just a little bit because the time is going and we have three Council members right now who want to comment. And may I suggest we give them a chance to comment —
DR. SCHNEIDERMAN: Sure. I'll be brief. I'm sorry.
CHAIRMAN PELLEGRINO: No, no, no. Make a note of their essential comment and I'll will give you an opportunity to put them together. I have Dr. Elshtain next.
PROF. ELSHTAIN: Dr. Schneiderman, thank you so much for your testimony. I'm sorry I came in a bit late. I did read the articles that we received ahead of time written by you and some of your coauthors.
Let me begin by very briefly suggesting that there may be an interesting discrepancy actually between your quote from Willa Cather's wonderful book — I know it's one of my favorites — Death Comes to the Archbishop, in which death is "not regarded as a moment when certain bodily organs cease to function," but that does seem very much to be your understanding of death. You've said a number of times in your testimony that you've described that futility is simply keeping a body alive or keeping certain organs going. So there might be some tension there that you might want to explore between Willa Cather 's understanding given that you cite her in your own.
But the questions that I have — and I'll make them very brief — go as follows. First, in the discussion about compassionate exception, you note that the physicians, those caring for the patient, "should" consider this possibility. And I wonder why it's not stronger, why it isn't "must" consider in your characterization of the proper procedures as you understand them because it does seem to me that often there's an element of trust that's very important and fragile between an attending physician and other caregivers and the family with the patient who is terminal or seems to be terminal. And I think that it would enhance that trust, would it not, if you said must consider these kinds of exceptions if you're going forward with these sorts of directives.
Next, following up on Gil Meilaender's discussion, I, too, was wondering about the question of — and it relates to his — the ability to appreciate certain effects that constitute a benefit, and I take it that you mean by that that it's not just some objective assessment of certain physiological operations within the body but the patient's recognition of some of these efforts, and I'm sure it has occurred to you before this moment that this can get very troubling when you're thinking about patients with mental retardation and so forth, generally, not even in a situation of a terminal illness, but more generally those who can't appreciate on some fully conscious level what's being done on their behalf.
And then finally, the issue about ethics consultations. I read that over, and I had a few questions about that. Perhaps it's just my ignorance. But I was wondering where the ethics consultants — how are these people trained? How are they licensed? What kinds of ethics are they trained in? Ethics is not a generic thing. There's the ontological ethics, there's utilitarian ethics, there's casuistic ethics. So just saying "ethics" doesn't tell us very much where do these people come from and who are they. Again, how are they trained? What is their connection to the family, if any? Who selects them, and so forth? So it would be helpful to hear a bit more about that.
CHAIRMAN PELLEGRINO: Thank you. Next is Dr. Schneider .
PROF. SCHNEIDER: We're spending the rest of the day on this topic, and the things I have to say will probably fit in almost any of the slots. So why don't I wait until then?
CHAIRMAN PELLEGRINO: Thank you, Carl . Next is Dr. Hurlbut .
DR. HURLBUT: No, I didn't have any further.
CHAIRMAN PELLEGRINO: Thanks. Paul, I'm sorry. You were so retiring, I didn't —
DR. McHUGH: Again, Dr. Schneiderman, thank you for your presentation. And I want to begin my comments by saying that you've touched upon a lot of situations that I think every doctor has been in, in some way or another, and I feel that the good faith effort that you're making about those things is obvious to doctors who are listening to you. And so, therefore, my disagreements with you are to be seen as collegial rather than anything else. And those disagreements, I think, will be the subjects of discussion all of this day because they relate, I think, to the different audiences that you're speaking to and that sometimes I speak to.
Gil has made the point that you speak about a public, and it's not the same public that I know. And the issues in relationship, for example, to the Oregon death with so-called dignity program and the data that are coming from that, I want everyone to know that the Oregon group refuses to let independent psychiatrists to come in and see those patients and understand those records in terms that might allow us to judge whether those patients are really choosing freely these cessations or whether they were under either family, social, or psychological pressure in making those decisions for themselves. So there's lots of things to be said out there that are problematic and tend not to be mentioned both in your paper and your presentation.
But what it really comes down to in my concerns about these matters and relating to the intrusions of the concepts of ethics into our practice is, what really are we trying to do with our practice, given that medicine is a practice that goes case-by-case, and it's delivered at some level by a particular person who is attempting both for himself or herself and the group that he's with to flourish and become better, not only at the practice of the technique of medicine but at the expression and the process of doing this and the more strenuous virtues that our profession has intended to bring out in people and make it such a salutatory career for anyone?
The gentler versions of compassion and sympathy and the relief of discomfort are a certain kind of virtue. But they don't speak to the virtues that doctors are intended often to try to reach for, and those are the virtues of strength and commitment and long-term courage and effort that when brought from case-to-case often help to, not only see what we mean in our relationship with patients, but not at all uncommonly bring, not in these last cases that you're talking about, but often in cases where futility is claimed but when real effort is produced and strong energies are given to the patients, in fact, bring good benefits to them.
What I'm concerned about with the growth of concepts like DNR and futility has been a conception of practice emphasizing sympathy and neglecting the energy, entrepreneurship, and effort that real doctoring can bring and which can be undermined by concepts like DNR and futility.
So it's more at the level of, are we producing a really challenging environment for our young people when we ask them to consider futility as a real concept or whether we're making it easy for them to explain away their own weaknesses.
CHAIRMAN PELLEGRINO: Thank you, Paul . Dr. Schneiderman ?
DR. SCHNEIDERMAN: Okay. Let me start. I'm sorry. I don't know your name.
PROF. ELSHTAIN: Dr. Elshtain, Elshtain.
DR. SCHNEIDERMAN: Elshtain. Let me go back to front because you hit on something that we're very sensitive to, and I just came back from New York, before coming back out here, an ethics-credentialing project. We're a group of us ethicists, clinical ethicists, who are getting together to try to decide how do we answer you. You're right that lawyers have degrees. Physicians have degrees. Many other health care professionals have certificates. Ethics consultants don't. And we learned at this meeting that there may be over 1,000 ethics consultants who call themselves ethics consultants out there. We don't know what they do, and we're very concerned about that.
Now I can assure you that the folks that were in that study, the multi-center study, are superb, clinically experienced, sophisticated ethicists. That's why I chose them, proof of principle. If I were to try to see this heart surgery work, I would certainly pick the best hospitals to get the heart surgeons to see if it worked.
But we recognize, and you're absolutely right. I'm very sensitive to that, that we're going to try to fix that. But you're right.
PROF. ELSHTAIN: Just this much on that.
DR. SCHNEIDERMAN: Yes.
PROF. ELSHTAIN: May I just add that I'm not sure that ethics can be credentialed in the way that a physician or a lawyer can be credentialed.
DR. SCHNEIDERMAN: Yes.
PROF. ELSHTAIN: That is, I would trust my Aunt Martha, for example, as an ethics consultant ahead of a number of people that I've encountered when I'm teaching ethics.
DR. SCHNEIDERMAN: You can cite all of the pages in the Boston phone book and —
PROF. ELSHTAIN: No, no. I think often ordinary people are a pository of good ethical sense. So I'm wondering just about who are these people and where do they come from.
And also then just a question that we assume that you can develop a kind of expertise in ethics that is analogous to learning how to do brain surgery. I couldn't think of —
DR. SCHNEIDERMAN: Yeah. And that's why I did the randomized control trial. I'm an evidence-based doc. I really am. And if you'll look at my bibliography I do lots of researching including doing advanced directives work. We showed that it didn't make any difference. That was my surprise to me. And what are the attitudes of men and women? So you're absolutely right. But it looked like in that one study — that's the only one that's — well, we did one at UCSD, but that randomized control trial — ethics consultation reduced what we called non-beneficial treatment, in other words, patients who died in the hospital, we reduced the number of treatments they got and the days they spent in the ICU. So there was an effect that I don't think your Aunt Martha would get. So there may be something there. But I'm willing to say we need to know more.
Yeah. Again, I just want to make sure you know that when we introduced this notion of medical futility, it was limited. In other words, some of you know that doctors are always saying, "It ain't worth doing." I mean, I've got to point out, and I've had ethics consultations where we worked hard with the family, and finally everybody agreed, yes, this patient should have surgery. Okay. We called the surgeon, and the surgeon looks at her and says, "I ain't touching this patient." So the surgeon made a futility decision, and they do it all the time.
So you're right that we haven't — now I would never ever say because a person is mentally retarded they are not achieving a benefit. We limit to the in-hospital setting and in particular the ICU. We limit it to the permanent vegetative state to say nothing about the minimal conscious state, which they probably suffer. But in our notion as we define it — and I would never invoke futility.
So we wrote another paper, Nancy Jecker and I, where we showed where futility is being misused. So I think we're trying to be very careful.
Oh, "should" versus "must." I think you're right, but the lawyers are always warning us, if you say "must," that puts you in legal jeopardy if you don't do something because you just said you must do it and you gave a very specific something you must do. So I think that is just "should." I agree with you that we must do it, but I think when it was written they chose "should" rather than "must." The lawyers here might help us out with that.
You talk about death? I think that one of the things that we should realize, that that was the 19th Century. I try to point out that some of the religious notions of life, being paramount to saving a life, had an assumption that life was coterminous with awareness. What we have done today with our high technology is made life not coterminous with awareness, that there is a long extra-bodily survival that we manage. Vegetative state is the disease. Persistent vegetative is the iatrogenic form of that disease. In other words, patients had a stroke or patients had cardiac arrest for eons. But it's only recently that we took that condition and then prolonged it.
So actually I want emphasize that what we're talking about is a difference that we have to look at historically.
I'm supposed to answer — okay. Your concerns are rather striking to me that you get a bunch of eager aggressive doctors who have gone to medical school learning how to do things and doctors who make a lot of money but also psychic rewards doing things and you're worried that we're going to undermine that to such a severe extent that they would no longer pursue that original impulse? I don't think so. I think that —
DR. McHUGH: Well, I have good evidence that you're undermining it. That's the evidence of ongoing abuse of the DNR process that occurs in house offices. That's data in the literature. The futility concept will act in similar ways. Whether you know it — I'm sure you do know it, that doctors are humans and that their willingness to go for the gentler rather than the more strenuous virtues is a constant temptation, and we have to work hard on them.
We even have now oaths in our medical schools that begin, not with the benefits of the patient, but looking out for the welfare of each other to the point that you might —
DR. SCHNEIDERMAN: Oh, the welfare of each other?
DR. McHUGH: Well, yes, of each other and me to the point where you wonder whether young people are being encouraged to recognize the strengths that they have rather than the fact that they get sleepy. So there's plenty of evidence out there, Dr. Schneiderman, that turning to the gentler virtues does sometimes cut back on the more strenuous ones, and it's in the literature with good data.
DR. SCHNEIDERMAN: Okay. I can also point out that there are instances where cardiac resuscitation was done over-aggressively. The SUPPORT study showed that physicians, in spite of trying to be informed about what the patients wanted, over-treated and all that. So, yes, we're human. We're imperfect.
I grew up in the era of what we called the iron man — we were mostly men — where we hardly slept. We were proud of the fact that we could do anything. That softer virtue has been improved upon. As a matter of fact, now I've learned, unbeknownst to me, I probably made lots and lots of bad mistakes because I was sleepy.
So we have changed the medical environment in terms of the softer virtues, but I — well, okay, this is a perception that I think probably goes in both directions.
CHAIRMAN PELLEGRINO: Thank you all very much. I think we can spend our recess until 11:00 o'clock .
SESSION 2: MEDICAL FUTILITY
CHAIRMAN PELLEGRINO: Thank you, thank you. We continue the topic of medical futility. Our next speaker will be Dr. Robert Truog, Professor of Medical Ethics, Anesthesiology and Pediatrics at the Harvard Medical School and the Children's Hospital in Boston. Dr. Truog?
DR. TRUOG: Thank you. Good morning, President's Council and especially good morning, Dr. Pellegrino. I want to especially thank you for inviting me and for being an inspiration to me and, I think, to many others over the course of our careers.
CHAIRMAN PELLEGRINO: Thank you for having me.
DR. TRUOG: Larry mentioned the article, "The Rise and Fall of the Futility Movement," and, indeed, ten years ago I thought I had thankfully written my last thing about futility. And Larry is correct about many things, and he was certainly correct about this, that the futility debate has not gone away.
I think you have my slides and you also have the text of my comments. I'll stay fairly close to those but ad lib occasionally.
I'm going to begin by telling you a brief story about a patient I cared for a few years ago, warning you in advance that this story does not illustrate any clear principles or provide any special insight into the problems we're talking about today, but instead actually, I think, points more towards the ambiguities.
So Raoul was a baby who was born with a large frontal encephalocele, his brain coming out the front of his head, which was surgically repaired at birth. Unfortunately, this condition left him neurologically devastated and he never showed any signs of neurological development at all. He was diagnosed as being in a persistent vegetative state. His parents, who are Haitian, were young and homeless. And from birth onwards, the clinicians involved in his care recommended that Raoul be treated with comfort measures only, but his parents were resolute in demanding that everything be done to sustain his life, including eventual placement of a tracheostomy and a gastrostomy feeding tube.
Through countless family meetings and consultations from the ethics committee, the staff became cynical, and I would even say somewhat angry, on the suspicion that his parents were using their child for their own benefit, such as for things to obtain priority status for public housing, for example, or other forms of welfare. By 16 months of age, Raoul was continuously hospitalized, and negotiations with his family had reached a complete standoff.
One evening while I was attending in the ICU at Children's Hospital Boston, I received a call that Raoul had taken a turn for the worse and was being transferred to the ICU immediately. I still have a mental picture of his stretcher rolling through the doors of the ICU. He was blue. We could not feel a pulse. Indeed, he may already have been dead.
Remembering the many conversations where his family had refused to consider DNR status, I told the staff that we would attempt resuscitation. We initiated ventilation through his trach and began CPR, and then we made many attempts to attain intraosseous or central venous access. I personally made 20 or 30 attempts to try to place a subclavian line in his chest, all without success. After about 10 or 20 minutes, we did not have a pulse. We did not have any cardiac electrical activity. I called the code and declared Raoul dead.
Everyone was very upset about what had just happened. One of the nurses who had watched the whole thing came up to me afterwards and said that it made her feel like she was going to throw up.
I called Raoul's father on his cell phone, and I told him that he needed to come to the hospital immediately. His response was to ask me, "What happened? You didn't kill Raoul. Did you?" When his parents arrived, we took them to a quiet room and we brought Raoul's body in for them to hold. After about 10 minutes I came in to talk with them, fully expecting to receive the full force of his father's anger. Instead, I was utterly shocked when he tearfully looked up at me and thanked me. I asked him what he was thanking me for. He pulled back the blanket that covered Raoul's chest, revealing all of the puncture wounds on Raoul's chest from my attempts to place a subclavian line. He told me, "We never believed that you would try to keep him alive. We always thought that you wanted him to die. We now see that you really did try, and we're grateful to you for that."
Now, again, I'm not telling you this story to convince you in either way that what we did was right or wrong. And I am sincere when I say that I am deeply ambivalent about my decisions and my actions in this case. But I do think that it captures many of the elements that are present in the debate about futility.
Now many scholars have attempted to define "futility," but I think none have captured the essence of the issue better than this cartoonist. Here we see the family member dominating over the physician, demanding the impossible. The physician, browbeaten and submissive, is apologetically pleading, "I'm afraid there is really very little that I can do," even while he goes through the motions of trying to do something useful.
Now when Linda Emanuel spoke to you last September, she offered a differential diagnosis of futility claims. And I thought that this approach was actually quite useful, so I will offer a differential of my own based in part on the work of my colleague John Lantos.
In her remarks to you, Linda made the statement that the term futility is a marker for distress because something has been violated. I agree with her, and I would like to suggest to you some of the elements that I think play a role, either separately or in combination, in creating this sense of violation. And the elements that I will consider are those of power, hope, trust, money, and suffering. And I'll just say, Larry 's comments, which I enjoyed very much, were written more or spoken more from the perspective of physician's views about the goals of medicine and how those would apply to society, and the idea that, as a profession, we need to set the professional standards. And I think that there is a lot of truth to that. I'm speaking, I think, more from the perspective of what it looks like from the patient's side of things, how they see it.
So first is this question of power, which can be put in the context or phrased as, "Who gets to say no?" Now this has really taken a 180-degree turn over the last few decades. During the '70s and '80s, the debate was about the rights of patients to refuse medical treatment. And although today we recognize broad rights for patients to refuse treatment, in clinical practice, this is admittedly still a problem with many patients receiving far more treatment than they really want. Even so, over the past two decades, the central question has shifted to the rights of patients and families to demand medical treatment, and here I think we have little, if any, consensus.
A lot of this might depend on how one frames the issues. So, for example, those who ask — "Do patients and families have a right to force doctors to squander scarce time and resources on therapies that have no benefit in order to satisfy the irrational wishes of these patients and families?" — people who frame it that way will likely look at the situation differently than those who ask, "Do doctors have a right to arbitrarily ignore the values and preferences of patients and families using their own value systems to make life and death decisions for others?"
Bioethicist Arthur Caplan, I think, has helpfully characterized this as a debate about odds and ends, which is exactly the framework that Dr. Schneiderman presented, with conflicts about futility being framed around the questions, "What chance or probability of success is worth it?" — that's the odds side — and "What quality of outcome is worth it?" — that's the ends side.
And, again, I think a cartoonist gives us an interesting insight here with one lifeguard asking the other, "Good Lord, Gilroy, it's not for us to determine whether they're worth saving!" And I think surely we could agree that this is not a role for lifeguards. The question that we're asking now is whether this is a role for physicians.
The second element in my differential diagnosis here is that of trust. And for those of you who are clinicians, I would like you to reflect on your own experiences with cases of futility and ask if you would agree with me that most commonly, not always, but most commonly, don't these involve patients and families from the more marginalized and disadvantaged segments of our society? These are families who have lived on the outskirts of our health care system and who have frequently been denied or at least perceive that they have been denied care that is beneficial. Now we are telling them that they cannot have a potentially life-prolonging treatment. Why should they believe us when we tell them that providing this treatment would be futile?
Furthermore, we must admit that for the most part they do have the data on their side. I won't review the evidence here, but if we look at large databases of critically ill patients like that from the SUPPORT study, they show us that "evidence-based" predictors of mortality are highly unreliable when applied to individual patients.
The third element in my differential diagnosis of futility is hope. Of course, hope is a good thing, even a necessary thing, in the face of critical illness. As the poet Maya Angelou wrote, "In order to survive, a human being needs to live in a place furnished with hope."
And in this area I have learned a lot from my colleagues in palliative care who, I think, have been especially skillful and insightful about how to help families reframe their hopes over the course of an illness from initial hopes for cure and recovery to eventual hopes for peacefulness and closure.
Nevertheless, we must admit that there are times when unrealistic hopes can interfere with good decision-making and with good patient care, such as when hopes for a miracle drive families to insist upon inappropriate use of life-sustaining treatments. And I would point out that at times we even unwittingly feed into this problem.
There was a fundraising campaign from a children's hospital very close to where we sit which was built around the theme, "We make miracles happen." So that was the theme they broadcast. So no surprise when families come in and say, "We're waiting for the miracle."
All of this, however, I would submit is very much a part of human nature. For example, if I were to ask to see the hands of those of you in the room who have ever purchased a lottery ticket, I think we would see a lot of hands go up. Now lotteries have been described as a tax on those who are not very good at doing math, and I think that that's correct. Nevertheless, when the payoff is big enough, many of us are willing to take unreasonable and even irrational risks. That's just human nature. For those in the ICU, where death may be the only alternative, is any chance of success really too small?
The fourth element in my differential diagnosis is money. I think that the work of Larry Schneiderman and his colleagues has been very helpful on this point, particularly in how they have differentiated the debate of futility from the debate of rationing, and Larry touched upon this at the end of his comments.
So in one of his articles, Larry wrote that "rationing refers to the allocation of beneficial treatments among patients, whereas futility refers to whether a treatment will benefit an individual patient." In other words, in Schneiderman's view, denying futile care to patients and families should have nothing to do with saving money. If a treatment is futile, it's not worth doing no matter how expensive it is, no matter how cheap it is, indeed, even if it's free. If it's futile, it's not worth doing.
Now theoretically I agree with this point. The fact is, however, that futility debates rarely arise around treatments that are cheap and easy to provide. So, for example, if a woman with widely metastatic breast cancer demands to be provided with high-dose vitamin C in the belief that it will be beneficial, I suspect that few of us would object. After all, it costs almost nothing. It's safe. Who cares if it doesn't work, as long as it makes the patient feel good? On the other hand, if this same woman demands treatment with high-dose chemotherapy followed by a bone marrow transplant on the same belief that this treatment would be beneficial to her, most would refuse, on grounds that such treatment would be futile.
So even if we agree that futility judgments should be isolated from financial considerations, in the real world, these judgments tend to be applied only in situations that are thought to be resource intensive.
Now we know that most Americans are allergic to the concept of rationing in health care. But my point here is to suggest that — and Larry is not one of these — but many proponents, I would say, of futility want to use this concept as an end-around approach to rationing and saving money. In other words, if you can label something as being futile, then you can successfully deny this treatment to someone without having to acknowledge that what you are doing is rationing.
So let me build on this a little bit more. Last year, Harvey Fineberg, who is the president of the Institute of Medicine, gave a lecture at Harvard where he commented that while rationing is absolutely essential to the functioning of a health care system, we need to give it a different name. We can't continue to speak about rationing. So the name he prefers to use is "cost-effective care." While I think this expression is somewhat euphemistic, I agree that it is much more socially palatable than the word "rationing."
So let's use his term and think about what it might mean here. If we think of the big circle here as the universe of all potential treatments, then clearly to have a sensible and affordable health care system we want to identify the subset of those treatments that are cost-effective. Furthermore, if there is another subset of treatments that can legitimately be defined as futile, they would fall over here in the sphere of non cost-effective care. The problem, I suggest, is that any fair approach to separating cost-effective from non-cost-effective treatments must be willing to look across the entire spectrum.
So consider, for example, the case of Avastin. Now Avastin was initially approved for advanced colon cancer where it would extend life by about four months. It cost as much as $100,000 a year. Last year Genentech reported $2.3 billion in sales in the United States alone, and this does not include the substantial mark-ups that are added by physicians and hospitals to that cost, which third-party payers are obligated generally to pay.
So here we are paying for this treatment which extends like by only four months and, indeed, recent studies suggest that it's probably even less. Stunningly to me at least, this past February Avastin was approved for patients with breast cancer by the FDA. And I'm sure you know this. But it was against the recommendation of its own advisory panel and amazingly despite no evidence that this drug either prolonged life or improved quality of life for the patients who were treated.
Now if Avastin were a unique example of an arguably non-cost-effective treatment which is routinely made available to patients, both on- and off-label, then the problem might be limited. But, in fact, Avastin is not at all unusual, and indeed much of the new drug development that is occurring in this country shares many of these same problems.
So here is the issue, I would suggest. If you look at definitions of medical futility that have been developed over the years, I think that Avastin must surely seem to fit within that category, particularly for breast cancer.
If our goal is to provide only cost-effective care, then why aren't we talking more about many treatments that are like Avastin? Why are we singling out this area right here of so-called futile care for patients in situations which are arguably the most contentious, the most divisive, and the most fraught with difficulties in terms of jeopardizing trust within the patient-physician relationship?
Furthermore, as if that was not enough, there is even more. Even if we're willing to take on the contentious issues around hope, trust, the physician-patient relationship, there is evidence that even if we eliminated all futile care we would not save very much money.
This point is counterintuitive to most clinicians, because all of us can remember horrendous cases, like that of Raoul that I told you about at the beginning, that seem like an enormous waste of money and resources. Yet there is a powerful recall bias operative here. These cases stick with us. We remember them for years for reasons that are out of proportion to their true impact.
I think Larry alluded to this in relation to one of the questions, "How often do you actually withdraw life-sustaining treatment from a patient against the wishes of a patient or family?" It's actually very rare because in almost all cases we do end up reaching agreement. In almost all cases, mediation is effective.
Now I won't belabor this point, but let me quickly mention two studies that address this issue. So in the SUPPORT study of more than 4,000 critically ill patients, 115 were predicted to have less than a 1 percent chance of surviving two months. Of these, all but one died within 6 months and most died within 5 days. If we would have decided that further treatment for these 115 patients was futile and if we had stopped treatment immediately, about $1.2 million would have been saved.
Not only is this a relatively small amount of money in the context of 115 patients or in the context of the $2.3 billion we spent on Avastin, but the majority of the money would have been saved in the context of only 12 patients, 6 of whom were under 51 years of age, one of whom lived for 10 months, and all of whom had religious convictions not to have life support withdrawn. In other words, yes, we could have saved $1.2 million, but almost certainly at the price of considerable conflict and emotional angst.
And, second, here is a study from the group in Houston that developed and published one of the first futility policies. This was a retrospective review of patients in their adult ICU. And without going into the details of the study, their conclusion was that the frequency of futile interventions appears to be low unless one is willing to accept a definition that includes patients who could survive for many months. This suggests the concept of futility will not play a major role in cost-containment. I could provide you with a number of other studies, all of which show essentially the same thing.
So Willie Sutton astutely robbed banks because that's where the money is. Why cannot we learn from his example and focus on problems like that with Avastin rather than fighting with families over controversial decisions about end-of-life care?
In sum, at the risk of sounding somewhat harsh, I think that there is this risk of wanting to use the concept of futility as a surreptitious way of rationing resources by denying marginally beneficial care to some patients without having to acknowledge that it has anything to do with rationing.
I think that this is wrongheaded, first, because it targets a generally marginalized population rather than spreading the burdens fairly across everyone in society, and, second, because it addresses a problem where the cost savings would be modest while ignoring the need to ration or eliminate treatments that are equally ineffective but where the cost savings would be quite substantial.
The fifth and the last element in my differential diagnosis for futility is that of suffering. There's two things going on here, and I want to clearly differentiate between them. One is the suffering of patients and one is the suffering of caregivers.
I want to emphasize that I think we need to take very seriously the suffering of patients, more seriously than we do now, and that we need to address it head-on. When family members are insisting upon treatments that cause pain or suffering to the patient, we should be much more proactive in challenging their role as surrogate decision makers, and if necessary seeking to have them legally replaced.
In comments that Thaddeus Pope made before this Council in September, he noted that recently the courts have been more willing to take this approach than they have been in the past, particularly in situations where the surrogate does not seem capable of fully appreciating and responding to the medical needs of the patient.
I do have a word of caution here, however, that comes from my own experience. When children are admitted to my intensive care unit, parents often ask us whether their child will suffer. We are very quick to reassure them, telling them that we take great pride in using sedatives, analgesics, and other techniques to assure that suffering is minimized or eliminated for the children that we care for. However, days or weeks later, when we again sit down and we're talking about withdrawal of life support, sometimes we will say something like, "Your child has suffered so much."
Now I am in no way criticizing this practice. I do it myself, and I think it's perfectly understandable and it's compassionate. But the point I want to make here is that in the context of futility we cannot ask the word "suffering" to mean whatever we want it to mean in order to suit our purposes at the moment. And I think the truth is that many times for patients who are involved in futility disputes they are either so neurologically damaged or deeply sedated in an ICU that I think concerns about suffering are greatly attenuated.
The other aspect of suffering though that cannot be ignored is the suffering of caregivers. And Professor Holly Lynch I think will say much more about conflicts of conscience tomorrow, but here I will only mention that issues of moral distress and burnout are of increasing concern among ICU clinicians, especially among nurses who have to stay at that bedside for as long as 12 hours at a time. And you can read the three quotes here. I think they're pretty powerful and I think they speak to the distress that clinicians feel in caring for patients in situations that they would identify as being futile.
Now from all I have said you might well conclude that I oppose futility policies and futility judgments, and indeed that is how my views are often characterized. Larry and I are often put at the opposite ends of the table at the pro-con debate and, while there are certainly things we disagree with, I think there is much that we actually agree on.
I am not opposed to futility policies. Indeed, I wrote the policy that we use at Children's Hospital more than 10 years ago. And I would completely agree with Larry that unilateral decisions by physicians to deny treatments are ubiquitous in medicine.
I'll give you just a quick example. One of the technologies we have in the ICU is called ECMO. It's a form of cardiopulmonary bypass, and this is a picture of a child on ECMO. Now with ECMO we can quite literally keep anyone alive. I mean, I'm not really overstating it when I say you cannot die in my ICU unless I let you die because I can put you on cardiopulmonary bypass and I can keep you alive almost indefinitely. So you might think, "Wow, what a nightmare." But it's not because we use it very, very selectively for patients who clearly have a chance of recovering heart or lung function within a relatively short period of time.
When this is not the case, I do not believe I have an obligation to offer ECMO to patients and families. I don't even have an obligation to discuss it with them and tell them that it's available but I'm not going to use it. And if they would demand to use ECMO in one of these ways, I would refuse. So that it's not that I don't think that unilateral judgments don't have a role in medicine, I think that they do. And here I'm in complete agreement with Dr. Schneiderman.
Where I disagree with Larry quite strongly, and I think it came out in our discussion, is that I do not believe it is possible to devise working definitions of futility. Here I am in agreement rather with the American Medical Association which expressed the view a number of years ago that "Judgments of futility cannot be made by reference to rules or definitions, but must be determined on a case-by-case basis."
I think we saw this in the comments of Prof. Meilaender here where we talked about, "Is it futile to treat a person in a persistent vegetative state?" And, Larry, you said that you accepted that view. On the other hand, it would seem to me that under the policies at UCSD and certainly under the laws of Texas that it's quite possible that requests for treatment for patients in a persistent vegetative state would be denied. So I feel like it's always got to be more complex than rules and definitions.
And here I think we have benefited from the insight of Justice Potter Stewart when he was writing about pornography and he commented, "I shall not attempt further to define pornography, and perhaps I could never succeed in intelligibly doing so. But I know it when I see it." I think there's a lot of wisdom here. If you try to define pornography in terms of certain anatomical body parts portrayed in certain ways, you're never going to get there. And I think futility is the same way. And, respectfully, I think that defining it in terms of a persistent vegetative state is very problematic.
On the other hand, I think it exists. I think we can actually identify cases where treatment is futile. But we're going to have to do it through a fair process. We're going to have to do it by consideration of absolutely everything that's involved and you can only do it on a case-by-case basis. And, again, this is where the AMA comes down.
Now the last comments that I'm going to make here have to do with comparing two procedural approaches to determining futility, both of which accord with the process defined by the AMA. I'm not going to go through this flowchart in detail. This is the flowchart they published in their article which advanced a procedural process.
Both of the approaches I'm going to discuss involve consultation from an ethics committee as well as attempts to resolve the conflict by transfer of the patient to other willing providers. Finally, both endorse the cessation of the futile intervention if the conflict remains intractable and if all opportunities for resolution have been exhausted.
So, first, let me discuss the policy at my hospital. So the Children's Hospital policy has all of these elements. So you can see that it requires ethics consultation. It requires intensive efforts at dispute resolution. It requires efforts to transfer the patient to another provider.
When all of that fails, it does have a provision for unilaterally withdrawing life support regardless of the wishes of the patients and family. But important to that is we also tell them, you do have legal options here. You can get a court order to stop us. And if you want to go that route, we will facilitate that. Indeed, if you want to go that route and you cannot afford it, we will make sure that your attorney fees are paid for. So that is the approach that we take.
Now how has this turned out? Well, we don't keep precise records on this. But I can tell you that the policy has been invoked on a number of occasions. But I can also tell you that we have never had to resort to unilateral decision-making.
Now when I say that in lectures, a lot of time there's chuckles around the room, "What a joke of a policy. It doesn't really work." I would say I would disagree, however. I would say the policy has had a number of effects. First of all, before we had the policy, clinicians did not bring futility cases to the ethics committee because they always knew the answer, "Just do what the parents say." And that is no longer the view.
When these cases come before us — and as Larry pointed out, they are very common — they are subjected to intensive efforts at resolution. In some cases after hearing everything, we decide — and this was the case with Raoul that I described in the beginning — the cost of proceeding with unilateral withholding or withdrawal in this case are not worth the benefits. In many other cases though, it leads to a resolution where the family comes around, and it's often in the sense of them saying — I mean, you'll have to believe me. This really is true. Families will say, "We are so impressed that so many people care so much about our child and what's going on," that they're actually attending all of these meetings and unanimous in feeling that what we are asking for is wrong, and it leads parents to just simply reconsider their views and say, "Maybe this is the right thing to do and we should withdraw life support." That's usually how they end.
Now although we've never had to get to the point of saying we're going to unilaterally withdraw, I do want to emphasize our policy does allow that, and I think we would go there if circumstances ever dictated that was the right thing to do. It just hasn't up to now.
Let me compare our policy with the law in Texas that Thaddeus Pope explained to you in some detail in September. So under Texas law, the physician's refusal to treat must first be reviewed by the hospital's ethics committee. The family must be given 48 hours' notice and be invited to participate in the process. The hospital must make reasonable efforts to transfer the patient's care to others, which, as Professor Pope noted, is almost never possible. And if no provider can be found within ten days, treatment may be unilaterally withdrawn. The family may request a court-ordered extension, which a judge should grant only if there is a reasonable chance of finding a willing provider, which, of course, there usually isn't. And, finally, the treatment team is immune from civil or criminal prosecution.
So I'm going to tell you what I don't like about that law and I must say I have not seen Larry McCullough's rather scathing comments which I'm sure were directed at me, but you can decide for yourself whether you think this works.
My objections to the Texas law center around its approach to due process. By the way, it wasn't mentioned, I don't think, that this was a law that was signed into law by then-Governor George Bush when he was governor of Texas. The TADA seeks to incorporate a due-process standard by insisting that all allegations of futility go forward only after they have been reviewed and approved by the hospital ethics committee.
In my view in such situations, the ethics committee is acting as a surrogate judge and jury with the statutory power to authorize clinicians to take life or death actions against the wishes of a patient and family. But whereas the judicial system in America assures us of access to a jury of our peers, hospital ethics committees are not held to this standard. Although it is true that most of these committees include one or two members of the community who are often grateful patients or family members of patients, most of the members of the committee are physicians, nurses, and other clinicians from the hospital staff.
Now I am in no way calling into question their motivations, their intentions, their sincerity, or any of that. But I think we must acknowledge that they are unavoidably insiders, completely acculturated to the clinical world and its attendant values. This is hardly a jury of peers for many or indeed most of those that I think are subject to these decisions. As such, I think the Texas approach relies on a due-process mechanism that is more illusory than real, and that risks becoming a rubber-stamp mechanism for systematically overriding requests that seem unreasonable to the clinicians involved.
And I may not know all of the data out there, but at least the papers that I am aware of suggest that this could be the case. At Baylor, for example, the ethics committee agreed with the clinical team in 43 out of 47 cases.
Furthermore, while we proudly look to our courts as the guarantors of due process, under the Texas law, judges have no latitude to overrule or even to amend the decisions of the physicians and the hospital ethics committees. Judges are only empowered to extend the ten-day waiting period and even then only if there is a reasonable chance of finding a willing provider, which is usually very unlikely. Despite these deficiencies, Professor Pope has suggested that perhaps that the Texas mechanism be adopted by other states and pointed out that it has now been invoked in Texas thousands of times even in the face of sometimes intensely negative press coverage. So these are the problems I have with the Texas law.
Of course, there are ways that the process could be improved. For example, in Boston the Harvard community has created a community ethics committee with members that come from diverse backgrounds, none of whom have any financial or social ties to the hospital. This committee has already produced several white papers on some controversial policy issues, but it is not currently empowered to comment on individual clinical cases.
But I think that, if thoughtfully structured and utilized, community ethics committees could be educated around key aspects of medical care at the end of life and could provide a forum for deliberation around such cases that would be much more free of the biases and conflicts of interest that, in my mind, plague the Texas approach. And although Professor Pope has been supportive of the Texas law in his writings and has recommended this again as a model for other states, in his testimony to you last September he did comment that he thought it was extremely unlikely that the Texas statute would last another six months given its failure to comport with the requirements of Constitutional due process.
So in sum, while I support a fair process approach to futility determinations and agree that under some circumstances it is ethical to unilaterally withdraw life support from patients against the wishes of their families, I believe that the Texas approach is seriously flawed and I believe that any fair system must still have some recourse to the traditional protections of the courts.
So, in conclusion, let me return to the case of Raoul that I presented at the beginning of my comments. Certainly this case was a tragic failure on many levels, mostly stemming from our inability to ever establish a trusting and workable relationship with Raoul's parents. This case had been referred to our ethics committee for evaluation under the futility policy, yet despite many meetings, many, many hours of discussions, neither the clinicians involved nor the members of the committee ever felt that we were justified in unilaterally withholding life support from this child.
Now one could certainly argue that this was a bad decision and that the patient and family would both have been better off if Raoul had died sooner. One could also argue — and I hope you will feel free to say this because I'm open to considering it — that I made very bad decisions that night when he came into the intensive care unit and that I lacked a commitment to ethical principle. Certainly others have said that. You won't be the first.
In response, I would say that, since I was convinced that Raoul was unconscious, any concerns about the code that we ran causing him pain and suffering were diminished for me. I did not think I was hurting him. If I had, I would not have done it. In addition, I felt it was important to honor the commitments that we had made to his parents. But most importantly, I felt that the 20 minutes we spent in the futile attempt to resuscitate Raoul allowed his parents to leave the hospital for the last time that day with the feeling that their child had not been ignored or abandoned by the health care system and that, despite our disagreements, their views and decisions as Raoul's parents had been treated with respect.
Again, while I remain ambivalent truly about how this case was managed or should have been managed, at this point I'm inclined to think that the positive psychological outcome for Raoul's parents was probably worth the 20 minutes of my time.
So thank you again for the opportunity to share these comments with you.
CHAIRMAN PELLEGRINO: Thank you very much, Dr. Truog. The discussion can now begin with members of the Council and signify your desire to do so. Before we do so, however, we will hear from Dr. Landry who will open up the discussion for the Council.
DR. LANDRY: So thank you for an excellent presentation. I found it troubling to consider the futility issue when it covers such a broad range — not that your remarks are troubling — but it covers such a broad range of activities from withholding water to deciding to start or perhaps withdraw ECMO. At one end, things start to look like euthanasia. At another, it's sort of the standard medical decision-making we all engage in.
I'm primarily a researcher, but my clinical practice is ICU medicine. So your approach in which the interventions are graded depending on whether it's vitamin C or ECMO and everything and was treated on a case-by-case basis sounds like the way we would like to practice medicine. The vector needs to be in the direction of providing care and attempting to cure. It seems very reasonable.
And yet we see that eventually every member of the team is opposed to going further. And so while there is an exercise of power, it's at least not arbitrary unilateral power when every physician in these complex cases in the ICU have many doctors caring and many paraprofessionals caring and your profusion is at the bedside and everything is moving forward and everyone is coming gradually to the conclusion that this truly is hopeless, that life is going to end. So hope will be lost, perhaps "trust me" maintained in the fact that everyone tried, and yet everyone is seeing the end is coming.
Suffering for the staff? I actually tend to discount that. I think that a patient's suffering and suffering of families takes precedence.
So let me just comment on the issue of money, and I'd ask you whether perhaps there was a little bit of a straw man in the money analysis, if you can just address this. You have the issue of rationing versus cost-effective care, and I would submit, just as therapies range from vitamin C to ECMO, the range of critical illness is also a broad range and so many of our patients who are on the floors could be in an ICU. Many patients backed up in our ED could have gone had there been openings.
And while we're always directed to the patient before us, it's perhaps not too illegitimate to recognize that triage is a constant reality in major medical centers. It's just constant. And in none of the presentations we've heard did I hear the word "triage" come up. It's just this constant background of triage, and so patients are going to suffer as we exercise mercy to those who want to extend things a bit longer. So perhaps you can comment on the limits of mercy and the reality of triage.
CHAIRMAN PELLEGRINO: Thank you very much, Dr. Landry. Dr. Truog?
DR. TRUOG: I would have used the word "triage." I was sort of enfolding it within the concept of rationing, and I think that rationing is absolutely essential. I think the core part of what I was trying to say was, let's call a spade a spade. Let's say that when that patient doesn't come up from the emergency room that it has to do with decisions we made about how many ICU beds we're going to have and etcetera.
So that rationing, I think, is ubiquitous and we need to hit it on face-to-face, and I think that Dr. Schneiderman would fully agree with this. He would not want to see the idea of futility conflated with that of rationing.
What are the limits of mercy? So that when Raoul came into the ICU was it the case that there was somebody down in the emergency room who did not receive life-sustaining treatment because of what we were doing for Raoul? I think that that would be a very legitimate challenge, and I would say that those kinds of head-to-head comparisons are unusual. But I think when they would come up, yes, that would be a limit to mercy.
And I think maybe just really briefly getting to the earlier parts of your comment, again, those of you who are clinicians I'm sure will resonate with this, is that on rounds you will constantly hear the residents going, "Oh, my goodness. I can't believe we're doing this. This is futile. This is ridiculous. This is insane." And yet what a change happens when you actually sit down in a room with a family. All of a sudden, everyone becomes much more reasonable. I mean, all of a sudden, they're hearing a family express pain and suffering and hope and those treatments don't seem quite so ridiculous as they sounded back in the staff room together, and that is the real value of this negotiation process.
CHAIRMAN PELLEGRINO: Dr. Schneider?
PROF. SCHNEIDER: I have a few things that I want to say. With relationship with each other, I'm not yet certain of.
The first thing was that I think there would be much to be said in favor of our finding a better word than "ethics committee." The way that ethics committees have actually developed is not a group of people who sit around and talk about ethical problems.
The real function they serve, and I think it's often an extremely valuable function, is this dispute resolution, mediating, "let's try to figure out some way of solving this that we can all live with" approach. That is an extraordinarily valuable thing to have done, but it has nothing to do with an understanding of ethics. And I think the worst thing that could happen to an ethics committee is that it begins to be treated as a group of experts on ethics and you had people who were trained and certified. You're already moving very quickly in that direction in the regulation of research, and it's a disaster. It's a disaster because the kind of ethics that are taught are so simple-minded that they discredit ethics.
The second thing I wanted to say is that I haven't looked at the literature for a couple of years. When I looked last time, I was interested in how important it is for us to be spending a lot of social resources trying to structure the way that decisions at the end of life are made, and I'm moving beyond just the futility argument to talk more generally about the larger problem that is taken to be very serious of people, particularly people who can't make decisions for themselves, about whom some kind of end-of-life decision has to be made.
So I tried to get a sense of just how much of a problem this is in real life. And the evidence I found was spotty but all in the same direction, and it was that there really isn't a problem, that in a very large number of cases, in the vast, vast majority of cases, what happens is that either a physician or a family member says, "I wonder whether it isn't time when we should begin to think about quitting." And within 24 hours — I've forgotten the figures now — a large majority of the cases had resolved themselves in some form of backing down from treatment; by 48 hours, almost everybody. By 72 hours, it was a tiny fraction that were left.
When families were asked afterwards how they felt about the decision, the answer was almost always the decision was a very difficult one and who knows whether we were right, but we believe that we did everything that we could to make a good decision and we can't imagine that we would have made a better decision realizing that there was no happy solution.
When people were unhappy, they were unhappy for two kinds of reasons. The first kind of reason was that they were angry at the way the hospital and the doctors have treated them. They were angry at simple things like not ever having a place where they could be while their relative was dying. They would be basically living out in the hallway in front of the ICU.
They were angry because they weren't given any information. There was one woman whose story I have not been able to forget who said, "I would sit by my dying husband's bed trying to find out what was happening, and I was afraid even to go to the bathroom because I was afraid that during those three minutes the doctor and his swarm would have come and gone and I wouldn't be able to get any more information for another 24 hours."
The other place that real unhappiness arose was that there would be fights within the family. These fights were not fights about principle. They were fights about family members not liking each other very much and not getting along. These were fights that no amount of rational organization of mankind would ever get rid of.
And that brings me to my next point which starts off with the Schiavo case where it was quite clear that you were never going to be able to get any kind of happy resolution of this, no matter what kind of legal forms you used and no matter what kinds of persuasions you used because the family members were at loggerheads.
The Schiavo case is important to me because it raises a question that was talked about after Dr. Schneiderman 's talk and Prof. Meilaender raised. It's a problem with forming cultural understandings about how people should be treated when they are in these extreme situations. I think the better decisions are made when there are these kinds of cultural understandings and where it becomes easy for us all to say, "If you're in a persistent vegetative state, the default presumption is you no longer want to be treated." I think that something like that kind of a cultural understanding has actually arisen among people who think about these problems all the time amongst lots of physicians and bioethicists and so on.
But I think one of the things the Schiavo case revealed was that the public understanding and the professional elite understanding have become two very different things. I think that there is a lot of public support for the idea of not dragging treatment on too long. But I think the public was astonished to discover that, if you had somebody whose life you thought was not worth prolonging, that you could end it simply by starving the person to death.
We think about there are a variety of ways of thinking about that and whether it's the cessation of treatment or not. But I think that the public had clearly lost track of the conversation and that it is important for the conversation to take place in a public enough way that the public can see it.
And one of the things that I worry about when we hear about physicians saying, "Well, we're going to set professional standards. After all, we're the ones who really deal with this," is that that kind of social decision, social understanding, social participation, and the decision becomes very difficult.
CHAIRMAN PELLEGRINO: Prof. Elshtain?
PROF. ELSHTAIN: Thank you, and thank you for your testimony. I appreciated very much your insistence, your insight, that how questions get answered and how our view about certain issues get formed very much turns on how the questions are put, what kind of narrative is set in motion, how things are described, and that that has to be kept in mind at every point.
A quick comment to Prof. Schneider's very interesting comments. I think it would be better to call these people, given their function, mediation consultation or arbitration and dispute consults or something of that sort rather than to assume that you can have the kind of ethic superheroes who swoop in to save the day by laying down some definitive ethical claim or code. I don't think it works like that. And my impression, as someone who actually teaches ethics, is that often those who are becoming expert in the area of medical ethics, often the ethical universe that's presented to them is a pretty thin one if my encounter with some of the textbooks and so on is any indication. So that becomes rather worrying, too.
But here are my questions, [my] specific question. I think it's one big question actually for you. There is a sort of rule of thumb in law that certain extreme cases make rather bad law. And I'm wondering if something like that isn't going on with the rush to try to elaborate futility procedures, that you think of the worst possible kinds of cases or conflicts driven at times, given the testimony we heard this morning, by physician paranoia and fear as we were told and you conjure with those and then you say, "Well, we've got to get some procedures worked up to protect us from that sort of thing, even though it doesn't happen very often. Now we don't want to be caught short-handed."
So why do we need, or particularly you don't think we need although you've been involved in setting up some procedures. But I'd like you to answer why you thought they were necessary in your context and whether you think, in fact, for the most part we need some legal apparatus to try to force it? But this is legalization of complex medical questions, it seems to me.
Once you start to move to proceduralism, the law becomes your sort of example of how this should be done and you've prepared a procedure. And I think that bids to lose the emphasis that we've heard from Dr. McHugh earlier today and that you mentioned in your presentation, the emphasis on medicine is a sort of case-by-case profession, if you will, rather than one where you've got a kind of standardized procedure that is equally applicable without distinction to all. So what's behind this move to proceduralism?
DR. TRUOG: So before we had a procedure for evaluating futility cases, I think we had a big problem because clinicians felt powerless in terms of being able to really express a voice opposing the demands of patients and families, and —
PROF. ELSHTAIN: And did that happen frequently?
DR. TRUOG: Oh, very frequently, and I mean to the point that I thought it was really undermining the moral integrity of our caregivers. They're becoming cynical about what they're doing, "We're doing all sorts of things that are just ridiculous." So the policy created the possibility of a forum for discussion.
Now as Dr. Schneiderman pointed out, if that's all it is, the problem then is when that forum for resolution fails, where do you get any teeth in the process? The Children's Hospital policy puts the teeth in it by saying, "We can tell the family we're going to stop. But it doesn't remove any of the traditional legal protections." And my experience in ten years is that we haven't needed more than that, that this opportunity to really express our views with families, to have everybody who is caring for the child say, "This is wrong. We should not be doing it," is extremely persuasive.
Where Texas has gone is to provide a legal remedy so that, once the physicians say, "We shouldn't be doing it," it is boom, boom, boom, not only do you have the full weight of the law behind you, you're completely immune from any sort of civil or a criminal prosecution, and a judge can't even look at what you've done and say, "This is wrong." The judge has no option to do that. To me, that's going too far. So I like where our Children's policy has landed. I think it has been functional, and I think it has helped resolve these disputes.
PROF. ELSHTAIN: Just very quickly. And you think that it doesn't in any way undermine the case-by-case approach that is really the heart of medicine; that, in fact, it very much supports that?
DR. TRUOG: Absolutely.
PROF. ELSHTAIN: And your worry about the other would be that, in fact, it can undermine that?
DR. TRUOG: Yes.
CHAIRMAN PELLEGRINO: Thank you. One more question. I think Dr. Meilaender has a question, and then we will break for lunch.
PROF. MEILAENDER: This is really almost a little more a comment than a question, but if you want to say something about it, that's fine.
It's really just to express appreciation on two fronts, one very simple. Right at the end, you described yourself as ambivalent, and I would just say that I would only worry about you if you weren't ambivalent. I mean that seems to me appropriate there.
The other thing, when I think about how the Council started down the road, why we're talking about this, it's really not just that obviously it's an important issue that arises in the delivery of medical care, but it had to do with the question of conscience for medical practitioners and whether medical practitioners are somehow obligated to do whatever patients want and so forth, so that on the one hand, one doesn't or at least I wouldn't want to say that doctors and other caregivers are simply in service to the desires of patients, that it's almost not going to be a profession any longer at that point. And on the other hand, we would want to say that patients ought to participate in those decisions which, after all, involve them.
And there may be no perfect way to resolve that, but it does seem to me that — I mean, you called it a fair process or something to that effect. I mean, really what's at the heart of it is almost forced conversation. You can call it a negotiation if you want, but a conversation is almost a better word to start with. And that is a way of recognizing both of those things, contradicting patients or their surrogates are participants in that now they're being listened to and taken seriously. But the conversation doesn't presuppose from the start that the medical caregivers don't have a position from which they begin and might not even have decisions that they have to make. I mean, in that sense it seems to me a nice way of getting at the larger problem that started us down this road.
Like I said, it's not really a question, but a comment. But it seemed to me helpful in that way.
DR. TRUOG: Thank you.
CHAIRMAN PELLEGRINO: Thank you very much, Dr. Schneiderman and Dr. Truog, and we will now break for lunch and reassemble at 2:00 o'clock.
SESSION 3: MEDICAL FUTILITY
CHAIRMAN PELLEGRINO : [Everyone is] arriving on
time, or at least moving in the direction of the Council meeting.
And as long as the trajectory is in this direction, we'll go ahead.
I'm going to start with our first speaker this afternoon. We're
continuing our discussion of the subject of futility. And our next
speaker will be Dr. Susan Rubin, who is in [an ethics consultation]
practice from Oakland, California , and I might add, if she'll allow
me to, a graduate of Georgetown. And we're glad to have you here.
Susan, it's all yours.
DR. RUBIN : Thank
you so much. It's a pleasure and honor to be here today. And I want
to thank especially Dr. Pellegrino and Dr. Davis and council members
for the opportunity to discuss with you what I find is one of the
most challenging ethical dilemmas that we face in the clinical setting
today: How healthcare professionals respond when patients or surrogate
decision-makers request treatment that the professionals view as
futile, when there is a conflict over the values and goals that
ought to guide treatment.
It's a particular pleasure to join my esteemed colleagues, Larry Schneiderman and Bob Troug , who both have made such important contributions to this debate. And it's a treat to be back in D.C. As Dr. Pellegrino mentioned, this is where I began my own systematic study of ethics and bioethics under the guidance of Dr. Pellegrino and others at Georgetown and the Kennedy Institute of Ethics. So thank you very much for the invitation to be with you today.
Contrary to the impression I get — and you might have had,
as well — from reading the academic literature on futility,
I want to share with you from my vantage point as a front-line clinical
ethicist, I am finding that the concept of futility is alive and
well on the clinical front lines despite the fact that the underlying
conceptual and practical issues surrounding its use are anything
but resolved. I want to argue today that the concept of futility
cannot do the work its proponents think it can, and further, that
the answers to their concerns do not lie in futility policies, futility
professional position statements, or even in futility statutes.
Instead, what we need and what has been sorely missing in the futility
debate, is frank discussion of the underlying values and goals themselves
that are in conflict when a patient or family insists on a treatment
that the healthcare team thinks is futile. And what we need is a
genuinely fair process for addressing such conflicts when they arise.
I was thrilled to get the invitation to come and present to the council because it signaled to me that you too shared my sense of the importance of this issue. And I am really hopeful that you in your discussion, and perhaps even recommendations, on this issue will be able to have an impact on the future direction of the futility debate and on our understanding of an approach to so-called futility cases at both the clinical and public-policy levels. So I'm really, really happy to be joining you in the conversation.
Let me give you a sense of where I'm going to go today in our time together. First I want to describe the impact that the concept of futility is having on communication and decision-making in the clinical setting. Then I want to outline the fundamental problems I think are associated with the appeal to the concept of futility. Third, I want to offer what I find a more fruitful and defensible approach to so-called futility conflicts. And last I want to highlight the unresolved issues in need of public discourse and which could benefit tremendously from the council's input.
It wasn't long ago — and we got a sense of this from Bob
Troug's presentation — it really wasn't long ago that patients
and families were struggling to assert their right to say no and
finding themselves in conflict with healthcare professionals who
felt a very strong moral obligation to continue what the patients
and families would describe as unwanted or unduly burdensome treatment.
Now the roles are reversed. And it's almost as if the scripts that the patients and families used to say were handed over the table to the physicians and healthcare professionals, and the scripts, the things, the arguments that healthcare professionals used to make were handed over the table to the patients and families, and they're now making their counterpoint's arguments. We can see this as we notice the shift in the fact patterns in the evolution of cases from the Karen Ann Quinlan case to Cruzan and more recently Terri Schiavo, on the one hand, which represent in my mind, really, the first paradigm case in foregoing life-sustaining treatment in bioethics, and then moving to what I want to identify as a new paradigm case in foregoing life-sustaining treatment characterized by a few cases you've heard referenced to already today, the Wanglie case, the Baby K case, and the Gilgunn case.
Now, thanks to the first line of cases, even though at the margins we may not have perfect compliance, I would argue we now have pretty broad consensus about what to do when a capable, competent patient voluntarily asserts her right to say no to a treatment against the recommendations of her physicians, or when her surrogate decision-maker does so on her behalf. That's the first paradigm case.
I want to argue, contrary to the impression one might have from reading some of the futility literature or listening to the proponents of the concept of futility, I don't think we have the same degree of consensus. In fact, I would argue we have very little consensus about what to do in the counter case, the subject of our discussion today, when it is not the patients or surrogates but the healthcare professionals asserting their right to say no.
Now, at stake in both of these paradigm cases is the weight that should be accorded to a physician's assessment of what is best for her patient and what that physician ought to be authorized to do based on her value assessment. I want to argue the answer's pretty clear in the first paradigm case. We understand that physicians cannot impose their values on patients and force unwanted treatment on them.
The second paradigm case — and I want to acknowledge it's
not the exactly flip side — there are some important philosophical
and conceptual differences. The second case admittedly turns on
a patient's request for treatment. And we'll, I'm sure, get into
a discussion about that. But still, it's not evident to me why in
this newer paradigm case around foregoing life-sustaining treatment,
why we are hearing arguments that physicians ought to have any more
warrant to impose their values on patients than in the first line
So what we see in this new line of cases is a new face to an old
conflict. Really, there's been a shift in who's saying no, and there's
been a shift in the approach that is recommended that is appealed
to in decision-making. What we see now, contrary to the first paradigm
case, where healthcare professionals were generally guided by the
technological imperative, "If we've got the technology, we
ought to be using it. There is an obligation to use all available
means," and when healthcare professionals were guided by an
acute sense of an obligation to save life, to preserve life.
Now instead we find healthcare professionals being convinced that they're justified in making unilateral — and, yes, I do use the word "unilateral" to describe this perspective — unilateral decisions to withhold or withdraw treatment they deem futile even over the objections of patients and families. And I want to give you a really clear sense from my clinical vantage point of what that actually comes down to, what that actually means. We are having, and I see routinely in my clinical practice, physicians argue that they have a right to deny treatment based on their assessment that the treatment is futile and over the objections of the patients and families, even when the patients and families are guided by a very different set of values and goals, even when patients and families may have a very different interpretation of the clinical facts, a different idea of risks worth taking, lives worth living, a different sense of what constitutes harm and benefit, the cornerstone of the physician's obligation to do good and to avoid or minimize harm. These patients and families have a very different sense, a different definition of what's beneficial and harmful to them. They also may have a different sense of what would constitute a good or an acceptable outcome. They may have a different valuing of cognitive capacity, a different vision of a good death, or a different perspective on the relative importance of sanctity versus quality of life.
Now, despite the fact that patients and families embroiled in futility
conflicts come from these different perspectives, physicians are
in the habit of saying, "If this treatment's futile, then I
have no obligation to provide it," even though the term and
its applicability are in fact highly contested. We can't blame them.
Their professional societies have told them as much. Some of the
professional societies have position statements that go so far as
to suggest it's not something that the physician even need discuss
with the patient or family or even need to get their consent for.
The dominant view is that these are ultimately medical decisions,
medical determinations, that should be made by physicians on behalf
of the patient. The problem is, these decisions all turn fundamentally
on values. And there's a conflict between the physician's values
— and I want to argue not just the individual physician, but
perhaps in some instances the medical profession at large —
and the patient's values or the lay population's values.
So part of the question the futility debate calls on us to examine, and what I look forward to discussing with you today is, how do we want to respond to genuine conflicts of value when they arise in the clinical and public-policy arenas? And these are the questions to which we now turn.
I think the core questions at issue in the futility debate really are, who should decide when to stop and when to proceed with treatment, what sort of values and whose values should be determinative, and what kind of decision is it anyhow, a medical decision or a moral decision?
Now, how we each answer, particularly this last question, really reveals which side of the futility debate we're on and why. If we think that the decision about whether to go forward with treatment or whether to stop is an exclusively medical decision, then it makes absolute sense to assign decision-making rights and responsibilities to the physician. The physician should be able to set limits based on their assessment of medical futility. But if we think it's primarily a value decision, we're going to not be so comfortable with physicians unilaterally overriding the patient's value perspective.
Now, I'm going to come back to this next point later, but I do want to say at the outset, lest I be misunderstood on this point, I do want to clarify that by posing the question in this way, I am not by any means suggesting that medicine is devoid of moral values.
DR. McHUGH : Thank God.
DR. RUBIN : Thank God, right. Rather — and I want to be careful about this, and I'll have to argue this, and I'm prepared to do so — rather, I am signaling the need to highlight the value dimension of decision-making and the moral values on which a physician's recommendations depend. So we'll get back to that point in just a little bit.
Now, in the current climate, the answers heard most often to these core questions are that physicians should be empowered to decide when to stop and when to proceed because it's ultimately a medical assessment, a medical decision, not a moral one. It wasn't that long ago that we were answering the question differently. And I really take tremendous guidance from the Imbus and Zawacki article which Dr. Schneiderman referenced as well. Imbus and Zawacki wrote this very important article in the late '70s in the New England Journal of Medicine, and it was entitled, significantly, "Autonomy for Burned Patients When Survival is Unprecedented."
Now, they didn't use the word "futility." It preceded
the current futility debate. But they were talking about a similar
fact set. When no one has ever made it with that particular degree
of total body burn, what do you do? What values ought you be guided
by? And it's significant that they entitled their article "Autonomy"
for patients in that condition, not "beneficence or nonmaleficence,"
try to do good, try to avoid or minimize harm from the vantage point
of the physician's value; and not "justice," not be careful
about the just allocation of our limited healthcare resources.
They argued quite differently from the argument that we hear today
and that we heard from Dr. Schneiderman, that the decision about
whether to go forward with full aggressive measures or to pull back
and pursue comfort measures, or what we now call palliative care,
was fundamentally a moral decision and not a medical decision, and
they developed a protocol around that conviction. So what they did
is, when a patient came in with that specified certain degree of
total-body burn, they didn't presume that their knowledge of the
medical facts and statistics ought to entitle them to know what
the right course of action was. Rather, they argued it was imperative
to engage the patient in dialogue, a very different approach than
many of the position statements on futility take today. They argued
that they needed to engage in dialogue with the patient and fashion
a treatment plan around the patient's values and goals.
Now, like William Knaus, the developer of the APACHE scoring system,
they argued quite explicitly that the medical facts themselves and
all the outcomes data in the world couldn't tell you what the right
thing to do in a particular patient's case was without knowledge
of the patient's values and goals, a very different understanding
and definition of medical indication and contraindication —
[you] cannot come to a conclusion about what's medically indicated
or contraindicated based on the science and the medical facts alone.
You need to get the values data about the patient to understand
what the patient's goals are and how they would value different
potential treatment courses.
They understood — and I want to call for a return to this — Imbus and Zawacki understood the need to bring the values data into conversation with the medical data, the "S" and the "O" from old SOAP notes that medical students learned originally. The "S" is the subjective, the "O" is the objective; you can't make an "A," an assessment or a plan with a "P" unless you bring the "S" and "O" into conversation with one another. And that's exactly what Imbus and Zawacki advocated for, and that's what they did.
They would enter into conversation with their patients. They told them everything they knew clinically. They assumed — and this is really significant, and something I don't see routinely happening — they assumed a posture of curiosity in these conversations and an openness to hearing how the patients valued and interpreted the medical data.
Now, the majority of patients in the Imbus and Zawacki study chose what we would now call palliative care. But a few of them chose full aggressive measures, saying things like, "I don't want to go gently into the night. Isn't that a defensible viewpoint?" Or, "I've always been the one to beat the odds. I want to take the chance; I want to buy that lottery ticket." And for those patients — and they were the exceptional, rare patients, as I will suggest would be the case in our current futility dilemmas — for the rare patients who wanted the full aggressive measures, they agreed to provide it.
Now, this approach is not so antiquated; it's not such an anomaly. It has and should continue to be the practice of medicine to take into account the subjective values and goals of patients to determine what treatment plan would be most appropriate for them.
I like to use an example of two women diagnosed with the exact same metastatic cancer. Everything about their cancers is identical diagnostically and prognostically. What's really different is their values and their goals. We could describe one of these women as having cared for several family members with the exact same kind of metastatic breast cancer. She knows exactly what she's up against, she knows what it looks like, she doesn't want to take the first step down that path. She would rather choose to have a shortened lifespan than endure the burdens of the treatment that she saw up close and personal with her family members. She wants to die quickly and peacefully.
The other woman with the exact same diagnosis and prognosis is awaiting the birth of a first grandchild seven months away, let's say. She's willing to endure anything just to get to that point. However horrific, however burdensome, it doesn't matter; she has a very clear goal.
Now, these two patients, I would argue, would appropriately be treated differently based on their different values and goals. For one, palliative care would be appropriate, just like the vast majority of patients in the Imbus and Zawacki study. But for the other full-court press would more likely serve the values and goals of the patient. That's what we call shared decision-making, not unilateral decision-making.
Proponents of futility would have us move away from that model of shared decision-making. They would presume that we can make uniform assessments of which treatments are indicated and contraindicated irrespective of the goals and values of the individual patient. They assume that the goals and values of medicine are universal and determinative. Now, we see this in the futility position statements, in futility policies, in futility statutes. What they all attempt to do is carve out an exception to the existing framework for decision-making.
Now, generally in our country, and somewhat uniquely so, patients and surrogates are understood to have a central role in the decision-making process. There's a fundamental right to informed consent or informed refusal. We would present the capable, competent patient with their diagnosis and prognosis and treatment options, and we would engage in discussion with them, and we would allow them to choose to pursue or reject the clinician's recommended treatment course, and we would allow their surrogate decision-makers to do that on their behalf. What we have found in the futility debate is physicians arguing, yes, that's true unless the treatment's futile. We're carving out an exception to the already-established framework for decision-making. But the key question, of course, is, futile from whose perspective and according to whose definition?
The other thing that's really striking about the way in which our answers have shifted from shared decision-making to professional position statements, hospital or community futility policies, and futility statutes is that, unlike the open-ended approach, the posture of curiosity advocated by Imbus and Zawacki, in a lot of these other approaches in the position statements or policies or the Texas statute there's a foregone conclusion, which is not our typical way of responding to a genuine ethical dilemma, a genuine conflict of values. There's a foregone conclusion that if the patient and family persist in requesting futile treatment, bottom line, the physician will ultimately prevail. The family, the patient, will lose. Now let's take a look at actually how that works.
There's been a number of professional position statements, and
I've described them in the article that you received in advance.
But as you know, The American College of Chest Physicians and The
Society of Critical Care Medicine, way back in 1990 came out with
a recommended stance for their physicians. The American Thoracic
Society has weighed in; The American Medical Association has weighed
in twice; The Society of Critical Care Medicine [has also weighed
And what I think these position statements all have in common are these three points: They work very hard to stipulate the goals of medicine and the scope of professional obligation; they share in common an assertion that there's no obligation to provide futile treatment; and now, in contrast to the very, very early professional position statements which actually talked about not even needing to discuss or inform the patient, most professional societies have dispensed with that and have acknowledged there is at least a duty to make what is called in the literature "courteous disclosure" that the physician feels that the treatment is futile.
And now most of the professional societies have moved in the direction of recommending procedural solutions. We can't get the answer on the substantive level, so we're going to move to a procedural approach.
So some additional things that I think are worth noting here are,
when you read each of these professional position statements, and
particularly reading them one after the other, what becomes really
evident is the degree to which they all depend on the correlativity
theory of rights and obligations. You can't have a right unless
someone else or some entity has a correlative obligation to meet
the right. So what I've noticed as I look at these professional
position statements is that they each quite deliberately define
the obligation of the professional in such a way as to inevitably
knock out the right. So the obligation is defined in a narrow way
so there won't be a right of access to patients who have a different
There also is in the professional position statements a resistance to the idea — and I think this comes largely as a contribution, Larry , that you and your colleagues Drucker and Johnson made — to produce — the idea that there is an obligation to produce an effect which they don't think is beneficial. There's a resistance to that. We don't have obligations to just make things happen in people's bodies; we have an obligation only to do things that are actually going to benefit patients. And you'll see that throughout the professional position statements.
Let me just read one, which is also in the article from The American Thoracic Society. And this is, I think, really thematic. You see this kind of approach in the other position statements as well.
"The purpose of a life-sustaining intervention should be to restore or maintain a patient's well-being, and it should not have as its sole goal the unqualified prolongation of a patient's biological life."
Now, they don't address the fact that the very effect of prolongation of life is a goal some patients would define as tremendously beneficial and absolutely serving their well-being, even if they can't appreciate it on a cognitive level. Now, it characterizes, this statement and so many others like it, is a conflation of the physician's role, from telling us what treatments are effective, which I would concede as properly within the scope of medical expertise, to telling us what treatments will be beneficial, which I would say is beyond the scope of the physician's expertise. This is one of the fatal flaws in the appeal to futility, which I will return to in just a bit.
So that's a little description of the professional position statements. Let me say a few words about these hospital futility policies. They follow a remarkably similar format. And here is the basic template: There now in most policies is the instruction that the physician can't do this secretively; they need to actually tell the patient. So this is good. Step 1, if you think a treatment's futile, you got to say it, you have to disclose it to the patient or their surrogate.
If the patient or family disagrees, offer a second medical opinion. That's in most of these policies. And if the patient or family still disagrees, bring in the other resources of the hospital. Try social work, chaplaincy, even ultimately the ethics committee.
And finally, if the patient or family continue to disagree, offer the opportunity for them to find some other healthcare professional who's willing to take on the case for transfer, or tell them they can go to court if they disagree.
Now, these templates that are used I think by many hospitals I think have some fatal flaws, and I just want to reference a few of them. They strike me as surprisingly imbalanced. Every step along the way, the language in these policies that I've reviewed suggests if the patient or family persists in their disagreement with the physician, here are the next procedural steps to follow. I've never seen a policy that says if the physician persists in her disagreement with the patient or family, here's the recourse that the physician can follow. I've never seen a policy that says if a physician feels so strongly that the treatment is futile and the physician persists in her disagreement with the patient, the physician can go to court, the socially sanctioned arbiter for intractable conflicts in society, and let that body which actually has the power to adjudicate render an opinion. That is — the imbalance is I think a significant problem.
Another significant problem — and others have noted this — is these final options — and we see this also in the Texas statute — the options of transfer and court are just not realistic options for most patients. And it's not just because physicians might tend to see this in similar ways and it might be hard to find a willing provider. I don't know about you, but where I come from, people can't just go to any doctor they want or any hospital. It's not the way our private insurance system works. So there isn't really the opportunity for free access that this would suggest.
We've already heard some about the Texas Advance Directives Act,
so I'm not going to make much comment here. What I want to do is
to suggest it follows the basic standard template of the hospital
policies, but it adds an additional step; it adds the step of immunity.
It gives the physicians immunity if they follow this policy.
Now, Bob Troug has already noticed this. The statute explicitly directs the courts to not consider the actual substantive dispute itself, to not comment on the question of is the treatment futile or not. They are only authorized to comment on whether successful transfer would be likely if additional time was granted.
We've already heard some of the problems with that use of the ethics committee, no specification of the composition, the skill of the ethics committee, or the nature of the ethics committee review process. There's also real concerns about bias. And we've heard already about how many times the ethics committees have actually sided with physicians, and the kinds of patients and families who tend to be differentially impacted in futility dilemmas, the absence of a meaningful appeals process. All of these I think should give us significant pause and not to mention the fact that this statute has been at risk of being repealed numerous times. So I don't think that we can hold it up as an example of emerging social consensus on the proper resolution to futility conflicts.
So, again, just to underscore the point, what all of these different
approaches — the futility position, professional position
statements, the policies, hospital or community policies on the
statute — they all have in common this attempt to carve out
an exception to the existing framework for decision-making. If it's
futile, the physician ultimately gets to not just say no, but the
physician gets to impose no.
So a heck of a lot is riding on this word "futility." And there's been lots of discussion in the literature about the fact that there's no agreed-upon definition. This has even been more recently in professional position statements actually acknowledged. The AMA statement in 1999 acknowledged a fully objective and concrete definition of "futility" is unobtainable.
Why is this the case? Futility is an instrumental concept. It all depends on the goal, the end we are seeking. It can never be defined in the abstract or without reference to the goal. And keeping that in mind, I think it should give us pause to consider the tremendous opportunity for bias. We already know there is a growing empirical literature on health disparities in this country. There have been studies that have clearly demonstrated patients being treated differently based on demographic factors of race and gender. They present with the exact same diagnosis and prognosis, and there's differential treatment of patients. We see this in studies showing bias about diagnosis.
There was a study in the early 90s out of UCSF showing that patients with AIDS or lung cancer were more likely to receive DNR orders than patients with cirrhosis or severe congestive heart failure, even though they had nearly identical prognoses. The physicians perceived these patients and these diseases differently, and they made different clinical judgments about the appropriateness of DNR.
So I'm worried. Once we acknowledge there's no agreed-upon definition, I'm worried about what factors will lead physicians or the medical profession at large to define a treatment as futile or not futile.
There's also a tremendous risk, of course, of uncertainty. I've seen futility judgments turn out to be wrong in so many different cases. Now, not only is there no agreed-upon definition of futility, there's also no agreed-upon — there's no agreement on the goals. Who ought to select the goals? Whose values ought to prevail?
Now, Dr. Schneiderman and colleagues Drucker and Johnson have argued that the goal of medicine is not merely to produce an effect, pretty powerful argument. They suggest there has to be a benefit, and they've added it has to be a benefit that can be appreciated by the patient. On this basis they define as futile continued treatment for a patient in PVS precisely because such patients are incapable of experiencing the effects of the interventions, and for patients who can't survive outside of the ICU, or now the acute-care hospital, patients who are permanently dependent on intensive medical care. But it's not at all clear that these treatments are futile or that the patients or families would view them as such. And I would argue it certainly can't turn exclusively on the scientific facts. It has to turn on the goals and values one has. Is getting out of the hospital the most important goal? It better be if we accept these criteria. Is being unconscious always a deal-breaker? It better be uniformly and universally if we accept these criteria.
And I am concerned about the slippery slope. You've mentioned,
Larry , that you were very careful just to have PVS and not dementia.
But I have seen the hospital policies, and you know those of which
I speak, [which] are modeled after the Schneiderman, Drucker, Johnson
approach and have expanded these criteria to include patients with
dementia, with severe dementia. So I'm worried about what this means.
Futility is inescapably an instrumental concept. It depends on
the values and goals that we have and the ends that we seek. Which
brings us back to the fundamental question: Whose goals, whose values
ought to guide decision-making, and what ought we do when the patient's
and physician's goals conflict? And here we have to acknowledge
the goals and values of healthcare professionals don't necessarily
correlate with the goals and values of the broader lay population
who may tend to be guided more by faith than science, who may tend
to rate the importance of productivity and cognitive capacity differently,
and who may be willing to accept greater degrees of impairment or
Even if patients deferred to their physicians' goals, even if there was agreement between the goals of the lay population and the goals of the medical profession, that's not going to solve this problem because the goals on which physicians rely themselves conflict. The traditional goals of medicine, preserving life, curing disease, restoring function, alleviating suffering, they may conflict when applied to a particular case. And the goals that are explicitly stated or implicitly relied upon in the futility position statements or policies may conflict as well. In fact, there's nothing in medicine, per se, that can tell us how to prioritize the goals of medicine or which to select in a particular situation. Better to preserve life or alleviate suffering? There's nothing in medicine that can give us the answer.
Now, this highlights the fact that there's always a value choice
to make in deciding on a particular treatment course, and it brings
us back to that ever-vexing question, whose choice ought it be?
As it stands now, value choices are being made without being explicitly
named. And this is a tremendous problem both clinically and on the
Let me give you one case in point. There's a whole literature on CPR and whether CPR is effective or futile in patients with metastatic cancer, with unwitnessed arrest, babies of a certain birth weight, and the list goes on. And there is clear empirical documentation of when we cross the threshold and when an attempt at CPR is futile.
Now, if you look really carefully at this literature, there is
a uniform implicit assumption about the definition of futility,
and there is an implicit selection of a particular goal informed
by particular values. The goal that is measured to determine whether
CPR, attempts at CPR, were successful or not is whether the patient
was successfully discharged to home. In none of the studies are
they measuring did the attempt at CPR restore heartbeat. So there
is an introduction of a new value perspective without adequate exploration
as to whether that would be an appropriate end or goal.
I was involved in a discussion just last week, as it turns out,
involving an 83-year-old woman with a history of bradycardia, slow
heart rate, renal failure, a stroke from — she had a very
difficult brain hemorrhage, pneumonia, and anoxic encephalopathy.
So she had suffered some significant damage to her brain from a
loss of oxygen secondary to a recent cardiac arrest.
Prior to this her physician had placed an AV fistula in anticipation of needing to start dialysis. That was before the arrest. Now she's in intensive care and the staff is up in arms. So I was doing my regular ethics rounds with this clinical team, and passions ran strong, as they always do in these cases. There was a profound sense of outrage and indignation that dialysis might even be considered.
Here's some direct quotes from the physician: "What would be the purpose of dialysis? It won't add anything meaningful except to prolong her life. Dialysis will be of no benefit. It will have no meaning. Dialyzing this patient would be tantamount to malpractice." Direct quotes.
The physician saw the question as clear-cut. There was no ambiguity; there was objective scientific fact. They had a hard time seeing that a particular set of values and goals were operative in their declarative statement and that those might be values and goals the patient wouldn't share. For the physicians, dialysis wouldn't make sense. It could only produce an effect on her kidneys. It would have to offer the possibility of what they would define as real tangible benefit such as waking up, being able to interact with her environment, being able to demonstrate some baseline cognitive capacity.
But is that how the patient would have defined "benefit"?
Were those her goals? Are those the minimum conditions she would
have set? Would she have agreed with the physician's assessment?
Obviously prolongation of life might be extraordinarily meaningful
to the patient. She might have viewed continued life as a unqualified
benefit. She might not have put the same premium on intact neurocognitive
capacity or relatability. But to the physicians it was absolutely
clear. Dialysis would be futile and should not be offered. There
was nothing more to discuss. This family just needed help understanding
this objective truth.
Given the possibility, in fact, even the likelihood, of conflicting
goals in so-called futility cases, a key corrective is always to
ask, "Futile with respect to what goal?" and "Whose
goal is it?" And there should and will always be an important
role for physician judgment and input, but as part of the equation,
not as the presumptive solution.
Larry Schneiderman and colleagues have great insights, and they're
absolutely appropriate to share in dialogue with the patient or
family, but they cannot be the start and end of the conversation.
In my experience, physicians and other healthcare professionals
are often too quick to label treatments as futile and meaningless
before they have a chance to learn more about the patient so that
they can effectively bring the "S," subjective, into conversation
with the "O," objective, rather than entering into the
conversation with a posture of curiosity like Imbus and Zawacki.
I hear physicians make sweeping declarations that shut down the
prospect for a meaningful exchange. Time and time again I've seen
families dig their heels in when they hear a doctor say there's
no point in continuing; this treatment's offering no benefit; this
treatment is futile.
These statements are present as self-evident truths, not as the physician's opinion based on her particular values or goals or the values and goals of her profession. It's not to say that physicians shouldn't have an opinion or that the medical profession isn't fundamentally a moral enterprise with its own foundational moral commitments, or that there isn't a place for moral assuasion in the clinical encounter. There absolutely is, particularly if the physician feels the treatment in question is causing harm. But when physicians express their opinions, it should be transparently clear that they are doing just that, and that they are arguing for a particular position based on a particular set of stated values and goals.
Now, I want to turn to offering an outline of what I would argue is a more fruitful and defensible approach to so-called futility conflicts. Too often physicians present patients and families with their foregone conclusion in what amounts to a monologue and not a dialogue. What I would call for is a return to the Imbus and Zawacki model early on in the clinical course, not just at the eleventh hour, in an effort to explicitly explore and establish the values and goals that are guiding the patient and the physician.
The physician would be encouraged to articulate her values and goals. The physician would be able to identify which treatment options might help achieve those goals and be consistent with those values and which might not. There would be an opportunity to discuss competing values and goals. There would be a possibility of genuine shared decision-making all along the way, assuming a posture of curiosity and engaging in genuine dialogue would set the stage for decision-making throughout the patient's course and create real opportunity to check in throughout to see if the agreed-upon goals are being met, if it makes sense to continue, or to try a different course.
To make these conversations constructive and to ensure the operative values were made transparent, it would be important to remember the generalization of expertise argument offered so long ago by Bob Veatch , one of my mentors. Physicians would need to be careful not to generalize from one area of expertise, making clinical assessments, to another area of expertise, making value assessments.
Now, how does this apply to futility? Surely the physicians would be in the best position to tell us that our 83-year-old patient had anoxic encephalopathy. But I would argue it would be beyond their expertise to tell us whether continued life with anoxic encephalopathy is worth living. They could tell us whether dialysis would correct the renal insufficiency, but it would be beyond their expertise to tell us that dialysis would be meaningless or that continued life in this patient's condition would not be worth pursuing.
The unconscious conflation of facts and values is an endemic feature
of the futility debate. And what I'm calling for is more discipline
and skill in distinguishing which kind of statements physicians
are making when making more transparent the values and goals that
are guiding them. We need to find ways of bringing the medical data
into conversation with the values data. And this would involve asking
a series of questions about the patient and his values and goals
to establish the frame of reference — and I've outlined this
extensively in the article that you received in advance —
asking things like what kind of person was the patient; what was
important to him; had he ever faced a health crisis before; what
kind of decision did he make; did he ever watch a made-for-TV movie
or read a novel where these questions came up, and what kinds of
things did he say? That's bringing the "S" into the conversation.
Then the physician can bring up the medical information and ask
the surrogate decision-maker, if it's an incapacitated patient,
"What do you think the patient would want now?" and "What
makes you say that?"
Now, so often in futility cases, physicians complain the family's
saying they want them to just do everything, and they're at an impasse.
I would say there's so much more that we can do in these cases to
move beyond the intractable conflict, not to stop with, "I
want you to do everything" or "I think the patient would
want you to do everything," but to really dig deeper. What
does that actually mean, "everything"? And then the patient,
if you think the patient would want everything done, do you think
he would want us, the doctors, to continue doing something if the
doctors thought it wasn't helping or if it was actually causing
harm, if it was increasing suffering or if it was burdensome? Is
that what he would mean? Did he mean he would want us to do everything
to keep him comfortable? So I think there's so much more that we
can do when we hear from a family in an intractable futility conflict,
And there's a place to address the angst and the moral distress
and the burnout that the members of the healthcare team feel as
independent moral agents. There's a place for moral suasion. There's
a place to make their best case for what treatment they think is
appropriate. There's a place to say, "We feel like we're torturing
your loved one," but not to stop there, but to be able to explore
what definitions of torture, what presumptions of torture are shared
or not shared by the family and the healthcare team.
In the vast majority of cases, assuming a posture of genuine curiosity, asking open-ended questions, being willing to really listen and being willing to share one's concerns I think will result in constructive rather than adversarial discussion. And I think if we did a better job with these kind of conversations, we would have a shrinking pool of actual futility cases. There may be some patients who would continue to request treatment, or surrogates on their behalf, just like in the Imbus and Zawacki study, but they would be the rare cases.
Now let's return to the case of the 83-year-old woman with the anoxic encephalopathy. This was very striking to me and not at all uncommon. As it turns out, with all their preoccupation with futility, the physicians in this case missed the chance to delve deeper into an exploration of who this patient was, what her values and goals were, what perspective she might have had about dialysis.
It turns out that the patient had told her daughter previously,
"If there's no hope for anything, I wouldn't want to be treated."
This little fact had been buried. And even when it was uncovered,
no one registered the significance of it, no one took the initiative
to explore with the daughter what her mom might have meant by that
What did "anything" mean, a certain kind of life? Would her current status qualify? Would dialysis be consistent or inconsistent with her values and goals? What made the daughter think that? If the team had taken more care with these kinds of conversations, asked the right questions approached in the right way in this case and others, I think it's unlikely that they would have gotten embroiled in a futility conflict in the first place. By leading off and ending with their own assessment of the treatment's futility, they left no room for exploring what the patient's assessment of her condition would be, no room for genuine dialogue, and no room for a mutually agreed-upon resolution.
So just as in the Imbus and Zawacki study, there will be some rare
cases even after following what I think is a more defensible approach
where a patient wants a treatment and the physician still feels
troubled by, perhaps even compromised by, being asked to provide
it. What should we do in these very rare cases?
One is I think we need to avoid physician unilateral decision-making. I'm putting this on the table knowing I'm going to get questions about this or reactions. I happen to be an advocate of ethics committees but not of ethics superheroes or as a substitute for decision-making but rather as broadly and diversely constituted committees with strong community representation who understand the scope and limits of their role and who make very careful recommendations that they understand to be advisory only and with an open-ended process where the ethics committee comes in not knowing where they're going to end up, and contrary to, I think, the template futility policies and remembering the role of the courts without shifting the burden of proof.
We have a socially sanctioned body that does have the socially sanctioned authority to impose decisions. That's not the medical profession. That's the judicial system. And I think that's where the rare exceptional futility conflicts need to go.
Now, let's return to the case of the 83-year-old patient. What if she had a different set of values and goals that led her to value the intrinsic sanctity of her life irrespective of its apparent quality to outsiders that led her not to need to be awake or to have the ability to talk in order to have a sense of connectedness with her maker and her loved ones, that led her to view every breath as precious? Why would it be any more a violation of professional integrity for a physician to honor that belief system than it would be to honor the belief system that led a capable patient to refuse a treatment her physician felt was absolutely medically necessary? That's a tough spot for physicians to be in, too.
Why is this alternative approach to the rare futility dilemma superior? One is, I think, futility dilemmas cannot be resolved by merely stipulating the superiority of one set of values or goals or by predetermining a default outcome in cases of intractable conflict.
What's been problematic is the undefended privileging of the medical profession's perspective without the necessary investigation into the deeper question of the degree to which society shares respect or endorses that perspective. There are issues about which reasonable people can and do disagree, and what we need is a more defensible way of responding to these genuine ethical dilemmas.
We need public discourse not just medical discourse about a number of key questions. And there's a place I think the President's Council could really take the lead. Rather than having the medical profession have these insular discussions with itself, we need to find opportunities to engage the very population that might find itself embroiled in these futility debates and whose perspectives have often been marginalized and even pathologized.
If there's time in discussion I want to share two examples that
I know of where this has taken place, both actually in California,
where there was a very different outcome, not an endorsement of
futility policies but, in fact, an abandonment of that effort.
But here's the key questions that I think we need to focus on at the public discourse level: Which values and whose values do we want to be guiding medical decision-making? What protection, if any, will be accorded to individuals who have a minority of perspective, for example, those who make religiously motivated requests? How will the need for a credible appeals process and the availability of meaningful options be addressed? What does it mean for medicine to be not only a moral enterprise but also a social practice?
It's incredibly important in this debate to acknowledge the moral tradition of medicine. But medicine is not practiced in a vacuum. There is accountability. There's a need for responsiveness to the broader community. And we can talk about ways in which that ought to go. Do we want futility to really represent an exception to the established framework for medical decision-making? This is a discussion not just to have within the medical profession but with the public at large.
And we need to be honest about the real motivations at stake. And here I think there's a need to separate out the justice question from the futility question. It would be very different to set limits based on consensually agreed-upon standards regarding how we want to spend and prioritize our collective healthcare resources.
It would be a very different thing to turn to the family of this woman with anoxic encephalopathy and to say, "We've decided collectively after much thought and discussion and a very inclusive public policy process"—Pollyanna as that may sound, but it happened to some degree at least in one state, in Oregon—"We are deciding where to spend our resources, and we've decided in that case," or let's say in the case of persistent vegetative state, "to only fund treatment for patients in a persistent vegetative state," let's say, "for three months." I'm picking that arbitrarily.
It would be a very different thing to turn to the family and to make that claim than to turn to them and say, "Treating your mother in a persistent vegetative state is futile." And what actually happens in the real world is futility is being used as cover for the justice concern.
I would argue we need to have the moral and political courage to
address the justice issue head-on. And I want to suggest for my
clinical colleagues who are routinely up in arms about the amount
of resources they're throwing down the toilet when they provide
what they think is futile treatment, if we took the time to have
the right kinds of conversations and reduced the end, the sample
size of these cases to what it really would be with a better, skillful
approach, these rare futility cases are not where the economic savings
are going to be, and we've already seen some data to support that.
If we focused on eliminating waste in the system, if we focused on making sure we weren't giving people treatment they didn't want in the first place, which turned out to be the case with my 83-year-old patient, there are places where we could really save money. Why are we focusing on these cases of so-called futility? This is not where the economic saving is going to be.
In closing, futility is not the answer. What we need instead—and
this is both at the clinical level and the public policy level—more
dialogue, less monologue; more transparency about underlying values
and goals; more openness to perspectives different from our own;
and more public and not just medical discourse. Thank you.
CHAIRMAN PELLEGRINO : Thank you very much, Dr. Rubin . I'm going to ask Rebecca to go first.
PROF. DRESSER : Well, thank you, Sue . I really think you make a very articulate case for respecting pluralism in these decisions. So I have some questions. I'm mindful of the time. I don't want to ask too many and give my colleagues a chance.
One question was to give us an example from your practice where you approached this or adopted a posture of curiosity and took your own message, and I think you've given us one, so I won't elaborate on that.
You don't address differences in two situations that I think may
merit some differential treatment. So in the case where a patient
is not making the request for a so-called futile treatment, but
the family is or the surrogate on behalf of a patient who is still
capable of experiencing pain and distress—there was an example
reported in the press—it didn't go to court—called the
Baby Rena case. I'm sure you're familiar with it: Eighteen-month-old
patient suffering from AIDS, heart and lung disease, pneumonia,
excessive cerebral spinal fluid in her brain, and kidney abnormalities,
breathed only with the help of a respirator, was in so much pain
she was kept constantly sedated, and when even the simplest procedure
was performed such as weighing her, would cry, although a tube in
her throat prevented her from making any noise. And she had some
foster parents who believed God would work a miracle.
So for me that is a more difficult case in that the people who
are insisting on the treatment are not bearing its burdens, and
there is a more, I think, legitimate role for someone to come in
and, certainly in your system, present the case on behalf of the
patient, the best-interest argument. So I wonder if you have any
further thoughts about that kind of a case?
And then I am interested in your call for community debate. How does that work? You mentioned the Sacramento project. Again, I don't want you to spend too much time so my colleagues can ask their questions.
And then, finally, what about the triggering event for having to bring something up? Bob Truog mentioned ECMO as a situation where a treatment that would appropriately not be raised as a possibility in every case. You must have some line where you would say it's not even incumbent on the clinicians to raise the use of a particular intervention as a possibility. So how do you draw that line? Thank you.
CHAIRMAN PELLEGRINO : Thank you, Rebecca .
DR. RUBIN : Thank you very much. The issue of the status of surrogate decision-making is a very important one, particularly as you've articulated when the patient might still have the capacity to experience pain or suffering. And I want to say a few different things about that.
One is I don't accept without challenge the claim that a surrogate decision-maker would make, and I want to second what I heard Bob Truog say. I would challenge the surrogate decision-maker, absolutely. But I would probably challenge them in a slightly different way, and it might depend on whether we were talking about an adult case or a baby case.
Let me give you two clinical examples. I had a case not that long ago of an adult patient in the intensive care unit dying of metastatic cancer and literally writhing in pain. And the nurses in ethics rounds were just up in arms. They couldn't conceive of the fact that this was happening in a modern hospital in this day and age and couldn't they do something about it. Well, it turns out that this patient was a practicing Buddhist. And for her it was far more important at the end of her life to be as alert and present and conscious as possible even if that meant enduring pain that others would have found intolerable. And she was refusing the pain medication.
So what would be interesting in that case is if she slipped into a point of incapacity. If we're turning to surrogate decision-makers to make genuine substituted judgment, for them to then override what they know she would want because it was uncomfortable for them or the staff might put them in a problematic situation.
So I want to leave open the possibility that a surrogate might be faithfully representing the patient's perspective. And I also want to say in these cases if we're willing to accept the surrogate's agreement with the medical recommendation it puts the burden on us, I think, to reject their refusal of the recommendation. In other words, in a lot of these cases there's a tendency to question the surrogate, but if they only agreed with us we wouldn't question them at all.
So I think we have to look at the question of what gives either the patient or the surrogate decision-maker status in the decision-making process. Is it because of the role that they occupy or because of the position that they're taking substantively?
And I would argue in bioethics we've said it's the role they're occupying, not whether they agree or disagree. It may be different in some baby cases because we wouldn't have had the benefit of the baby telling us that he was going to grow up to become a Buddhist.
And I've had cases like this in the NICU where the staff has felt like they're really causing tremendous harm. And I've had parents say a variety of things, and let me share a couple of them, because they were very poignant. One family member turned to the staff in the ethics consultation meeting and said, "Everywhere I look in this NICU there's pain and suffering, and you're causing it. And it's okay for you in your mind and in your hearts to do it for some babies because you believe the outcome that you're pursuing is one worth pursuing. And the reason you're saying no in this case is you don't think my baby's life is worth it like this or where he's going to end up? And I would challenge you."
And she actually said to them—it was quite powerful—"If it's too hard for you, maybe this isn't the right line of work for you to be in." It was a very bold statement. But I think she was right on some level to say, "You're doing chest tubes and needle sticks, and it's kind of ugly all around."
So the burden of proof is on the physicians and the team to say, "Why is it worse in this case than that case?" And I think she was exactly right to call to question and say, "It's because you don't agree that the goal is worth pursuing, but I think it is." So I think that that is one thing definitely to take into account.
In terms of the triggering event—I'm going to skip to the third question. I think the line—and this is a really hard argument to make, much less win, and I'm very aware of that. The best that I've come up with is relevance and irrelevance.
So if a patient comes in with a headache and they want the physician to chop off their arm, there's no plausible cause and effect as far as we know—maybe there will be some randomized clinical trial that establishes this—between loss of the limb and resolution of the headache. So I think that's a clear place to draw the line.
I'm not so sure with ECMO, although I'm persuaded by the reasons that would lead you to draw the line. If ECMO can sustain life and there's a relevance, a cause and effect between the technology and the goal, I think we need to find a different way of having the discussion about the goals, and I'm not sure that the technology itself can create the triggering event.
And, lastly, in terms of community debate, there's not a lot of
good models for this. But I think that it can absolutely happen,
and the two examples that were in the article include one local
hospital [that] was contemplating instituting a futility policy,
and they did this incredibly bold thing: They held a community forum.
And the community came, and the staff came, and they put it out,
the proposal, what they were contemplating. And it was met with
unbelievable resistance, and they disbanded the effort.
In the Sacramento health decisions experience, that began as an example to establish futility guidelines, and they eventually abandoned it in favor of a focus on improving end-of-life care when they came to the conclusion that there was no fair and defensible way to implement and impose such guidelines. And they involved the lay population in those discussions.
CHAIRMAN PELLEGRINO : Dr. Rebecca Dresser , any further comment?
PROF. DRESSER : No.
CHAIRMAN PELLEGRINO : I had the
following who wish to speak: Dr. Foster , Dr. Elshtain , Dr. Meilaender
, and Dr. Landry . Dr. Rubin , would you for a moment leave the
answers and put them together, if you can, because I think it's
going to take awhile for them to give you the answers and put them
DR. RUBIN : Okay.
CHAIRMAN PELLEGRINO : And I'll ask first for Dr. Foster , who was first on the list.
DR. FOSTER : I
want to make a statement first, and then I want to ask you one question.
I'm following Rebecca 's view not to ask many questions. I think
you can be very confused about the CPR issues. You stated or implied
that if one was a minority that one would have less CPR and so forth.
I work in an 800-bed public hospital in Dallas , which, by the way,
just passed an 83-percent approval of this bond to build a new $1.3
million hospital across the street even bigger than this. Grady
in Atlanta is bankrupt. So Dallas wants to have a first-class hospital.
Most of our patients are minority. Now in Texas , like California , Latinos are more than African-Americans there. And we have about 500 beds in the university hospital. We do far more CPRs in the hospital at Parkland than we do in the university hospitals.
Now, one could argue that that is because they're sicker patients, and I'm sure that has some sense in it. But in big hospitals—I'll see if Dr. Landry has the same experience—the codes are called and the minute they're called then the house—they know nothing about the patient.
If the attending physician is there on the ward they can say, "Well, we have a DNR here." But there's not a shred of evidence that I know of, at least in our hospital, that there's some discrimination that you wouldn't attempt a resuscitation if somebody was a minority, which was clearly the intent that you made.
And very often in CPR you get a heartbeat for a little while. So the issue of whether it's done anything except to live for an hour or 30 minutes—I mean, you sort of pooh-poohed that, too, that getting out of the hospital is an issue.
So that's my statement. And then I want to ask you a question. I thought that was a very unsustainable—at least universally unsustainable thing. Now, maybe in the United States that's the case, but I just wanted to make that point. When that bell rings, whatever the residents are doing, they leave where they are and go to code.
The question that I want to ask you has to do—I read your interesting paper, and at the end of it and as you've hinted here, the curiosity about the patient and talking with the patient—the first thing I would say is that I don't know of many physicians that are going to have the time to psychoanalyze a patient.
But the question is, does a woman with a dementia encephalopathy—can she validly make a decision about what she might do before she was sick, or did the surrogates usually have gone into detail about whether this person wants to do something?
I'm just worried about the practicality here and whether or not these assessments are valid. You know, we talk about dialysis. Well, you die in dialysis from heart disease, not from the renal failure. So how do you proceed?
And particularly since most people don't have long relationships with doctors—you know, if I diagnose you with cancer early on, it looks like it's a melanoma and it's not much, I mean, you and I would talk, and we would come to a conclusion about what you wanted to do and so forth. But in the short-term it's pretty hard. So the question is—if I've made myself clear—what about people who, under stress, assess answers to questions about life and particularly with surrogate persons?
CHAIRMAN PELLEGRINO : Thank you, Dan . I will now ask Profession Elshtain.
PROF. ELSHTAIN : Thank you very much, Dr. Rubin . That was admirably clear, and I read your paper, as well, and especially appreciated your argument against what you call paternalistic proposals in support of unilateral decision-making. And the question that I have follows from that argument in your paper.
It's a bit of a dilemma, and I don't expect you to have a developed answer to it. I certainly don't. But in your presentation and in your paper you talk about the importance of taking account of the patient's subjective views—values, if you will.
Now, I'm assuming that you would agree—you may have stated this and I missed it, so forgive me if I did, but I think it's consistent with your argument—that the physician's views when you get into the area of questions about what kind of life is worth living and so on and so forth—when you get into that area of values, those are equally subjective.
This is again outside the physician's area of direct expertise. So what you wind up with, then, if I'm understanding you correctly, would be a clash or some tension between two subjective statements of value.
Now, we know well enough that when that happens, when you—let's assume this scenario, that it tends to be those who have the power to impose their views that tend to prevail in those kinds of situations and that physicians in these circumstances and the whole sort of apparatus of the hospital has more power than the patient. Now, your solution to that or way to try to work through that is, again as I understand it, what you call genuinely open, inclusive public discourse. You really bring all this to bear. People have these discussions.
And what you often find out as a result of this is that the futility policies are sort of quietly put off to the side and something more appropriate to this particular case tends to emerge and will not necessarily always be decided in favor of the physician's views.
Now, so far so good, let's say. But as you well know, there are many who would argue that, in fact, we do not have a situation where you have equally subjective statements of value, that, in fact, some value claims have greater, stronger truth warrants behind them than other claims of value.
And that's always going to be implicit, it seems to me, in these kinds of discussions. In fact, there are some of us who would worry about talking about values as subjective claims in the first place because it seems to suggest that there's no strong truth warrant behind these claims. And that's why you wind up with power being the final adjudicator.
So probably the hospital and discussion about it is not the best place to settle these very complex kinds of statements of value, but one way or the other I think someone is going to say, "But my values—there's more support for them. There's more evidence for them. There's a stronger set of truth claims behind them than yours."
I mean, let me just—and then I'll end with this. Very briefly, over the span of Western history, for example, we've moved from the view that was accepted that there are some people who are slaves by nature—let's take that as a statement of value—to the view that that view is anathema.
We don't regard these as equal statements of value. We believe that there's been tremendous moral progress in moving from the one position to the other. So you can see a sort of fundamental shift in favor of a stronger truth claim behind a statement of value.
Now, that seems to me to be lurking in some of these debates, as well, because you're getting right to the heart of what life itself means, and there are all kinds of issues that are going to attach to that. So you're always going to have this very volatile mix, it seems to me.
Suppose that in this discussion that you're talking about—let's make it from the side of the patient, that someone steps forward and says, "There's"—and I'm prepared to make the case—"much stronger warrant for the truth of what I'm saying than what you're saying, even though you're the physician and I'm not." How do you sort that? How do you sort that out?
CHAIRMAN PELLEGRINO : Thank you. Let's have two more Council members comment, and then we'll give her a chance to respond to all four. Prof. Meilaender ?
PROF. MEILAENDER : Thank you. I'm very sympathetic to some of the moves you make, although I find myself starting to worry that in order to correct for one kind of problem you're going to create another one. I have two questions, really, that in some respects follow up on some of Rebecca Dresser 's questions.
You did say at one point that we could distinguish between treatments
that are effective, which you characterize as a medical judgment,
and treatments which are beneficial, which you characterize as a
judgment that includes questions of values and so forth. Would you
have any problem with a notion of futility based on effectiveness,
then, which would make it a medical judgment? That's the one. And
then the other, the fifth of your key questions was, "Should
futility represent an exception to the established framework for
That seems to assume that the established framework for medical decision-making is a sort of dialogueical process in which nobody has the final say or so forth. But do physicians have to engage in those discussions about everything that patients wish or propose?
I mean, I have in mind, admittedly, their unusual circumstances with the person who says, "Doctor, I've always thought that I'm really a double amputee, and I'd like you to do that for me." I mean, is there no place in your system for that kind of medical judgment?
CHAIRMAN PELLEGRINO : Dr. Landry ?
DR. LANDRY : I'd also like to pick up on something mentioned by Prof. Dresser , and that was the ECMO case. I don't think that the conflicts that we think will be minimized through further discourse will actually be minimized at all if you don't recognize that there can also be a certain tyranny to patient autonomy.
Every patient who expires in respiratory failure on a ventilator could in principle be offered ECMO. It would be cruel, actually, to raise that as a possibility. It would just be cruel to the family. And I think that it's an abdication of physician responsibility to simply offload everything that is possible without any consideration for what is reasonable. And so I think that, while I was with you for much, I was lost when you went that way.
CHAIRMAN PELLEGRINO : Thank you. Dr. Rubin ?
DR. RUBIN : Let's see if I can capture all of this. First, Dr. Foster , I think I was misunderstood, so let me correct that. I was by no means suggesting that when the code blue is called that the house staff would try to determine the race or ethnicity or gender of the patient.
What I was referring to is the empirical data that shows—you might recall this. I think it was in JAMA and other journals where there are photographs of standardized patients who come and present and are treated differentially in terms of a workup and proposed treatment. And I just was pointing out to the reality of health disparity on a general level.
In terms of will doctors really have the time to have these conversations and, I might add, much less the skill to actually do it, yeah, I think they do, and I think they must, and I have seen it done beautifully by hospitalists who have no prior relationship with the patient or the family.
I think we need to stress this more in medical education, and I think we can very effectively in very short order get to the heart of the matter in a conversation with either the patient if they're well enough or with the surrogate decision-maker.
DR. FOSTER : The last part, you talked about coming back for another session when the first session didn't work, and I thought that's what you said.
DR. RUBIN : And
then, Prof. Elshtain , thank you very much for your comments. And
obviously as you acknowledge, these are enormous issues. And let
me try to do my best to respond to some of them. So what to do if
someone says, "Well, my value claim has stronger support."
There's a strong truth warrant behind that.—How would I sort
There's a couple of things. I agree actually with Dr. Truog . When we get people together—and I say this anecdotally based on my own clinical experience—I think when people really hear each other there are almost always profound shifts that take place.
And this sort of digging in of heels and "My claim is better or has more support than yours" softens when we are real people grappling with a painful choice because there is loss on both sides. Whenever we make a decision we're choosing not to go down that path as opposed to this one.
So I'm less worried that that will be actually the dominant reality. And then I think there's a couple of things to say about it. Ultimately what we're talking about—and I don't mean anticipating the next question here to suggest the tyranny of autonomy should carry the day.
And I'm often misunderstood for making an argument that I'm not making, which is that whatever the patient wants the patient gets. So that's not what I'm suggesting here. But I think it ought to give us pause in these so-called intractable futility conflicts that while the physician and the other members of the healthcare team feel very deeply about this, ultimately, while it may have profound implications for them in terms of their own conscience, it's not ultimately their body or their life or their dying process.
And I want to suggest that that at least needs to give warrant to the patient or surrogate having an important status in the conversation, not trumping in all circumstances. And the hard situation will be to answer, "So where do you draw the lines, and when can patients be told no?"
And I think that we do have examples of that. Dr. Schneiderman talked about providing the anabolic steroids. Well, I would say that's a great example of the medical profession setting socially sanctioned limits, so really as a gatekeeper on behalf of society at large, which has chosen to draw lines in certain ways. And I think that that's going to be our best bet as we go forward in trying to sort this out.
We do turn to physicians. Going back to your question about the distinction between the effective and the beneficial, we turn to physicians, rightly so, for information about which treatments are effective, but I want to distinguish whether we should be turning exclusively to physicians in the selection of the goals themselves.
So in the clinical scenario that I presented, it's the physician that can tell us the diagnosis but not whether it would be beneficial to treat. So I don't know what I might be giving up by—you were suggesting that I might be weakening the argument by making that distinction between the effective and the beneficial, would I have a problem with futility judgments based on effectiveness.
I think if we have an agreed-upon goal that's consensually agreed upon between the patient/family and the physician, then I would turn to the physician to say, "Is that an achievable goal?" And I think that would be an appropriate exercise of the physician's expertise.
On the issue of the double amputee, which I think is similar to the anabolic steroids, I don't think that we have to—I mean, there actually are physicians who are offering this, as you know. There's some very interesting literature that Carl Elliott brought to the front in the Atlantic Monthly, and there are a couple of physicians who are treating these requests to become amputees the same as some physicians treat requests for gender reassignment. So it's a very complicated issue.
I don't think that physicians have to put every imaginable treatment option on the table. I think the patient comes with a presenting concern. And, again, I would turn to the relevant/irrelevant distinction as one way of helping the physician draw lines about what to put on the table or not. I think there's a lot more to say, and it's an incomplete answer to some really pointed questions, which I'm happy to follow up on.
And then, Dr. Landry, about ECMO, it very well may be ultimately cruel to put ECMO on the table for every patient, and it may be that we could achieve broader social consensus about that and that based on our vision of what most people view as a good death, it wouldn't be the thing that would be routinely offered.
But what I wanted to suggest is there might be exceptional cases where the sustaining of life would be the overriding goal for an individual patient and where the team might actually be persuaded in the exceptional case of the worthiness of that goal for that particular patient. And we could only know that by having the conversation. And if we could never entertain the thought of potentially offering an intervention like ECMO, we might miss those exceptional cases.
DR. LANDRY : But then you would have no problem with a physician paternalistically withholding the knowledge of ECMO from someone.
DR. RUBIN : I
think it depends on the context. I think I would imagine the conversation
going something like this: "In my clinical opinion, it looks
like your mom is coming to the end of her life, so let's talk a
little bit more about how you think she'd want that to go."
And if the surrogate starts representing things that are like the exceptional patients in the Imbus and Zawacki study, it might go one direction, and I think those will be very exceptional cases. And I wouldn't accept as stated the surrogate's description of "Oh, my mom would want you to do everything."
I would, as I've described, dig deeper, and I bet there would be
very few patients who would sign up for that. But there might be
the exceptional few. And if the answer is, "Oh, my mom's Aunt
Mary died the most peaceful, wonderful death at home," like
that cartoon we saw earlier with everyone gathered around with the
chimpanzee. And this is what she would wish for, then obviously
based on the subjective data, there would be no relevance to bringing
So I don't want to take off the table universally the possibility that we might introduce ECMO in an exceptional case, but I think in most cases it would end up being not relevant to the goal.
CHAIRMAN PELLEGRINO : Thank you very much. I think to keep the schedule we'll have to call this part of the session over for the next 15 minutes. A little bit of a break and then Dr. Carson and Dr. Foster.
SESSION 4: MEDICAL FUTILITY
CHAIRMAN PELLEGRINO: Thank you. Thank you all very much for coming on time from the break, un-breaking the break. First, to begin the last session this afternoon is one of our own Council members, Dr. Ben Carson. Ben, are you with us? Okay. Do you want to speak from there or do you want to speak from the podium?
DR. CARSON: I think I'll just speak from here.
CHAIRMAN PELLEGRINO: Okay.
DR. CARSON: Well, very interesting discussions today on futility, and obviously as a neurosurgeon, it's something that I have to deal with frequently. Just before I start just a couple of comments on some of the things that were heard today. The term "miracle" came up a number of times, and I know that there's certainly patients who are in very dire straights who are holding out for miracles, and I certainly have seen my share of them, but I tend to have one standard answer for them. I simply say, "Miracles come from God and not from people, and if He's going to do one, He doesn't need us to do it." And most people kind of understand that.
And the other issue is the case of Terri Schiavo. Now, I've seen a lot of people in various stages of persistent vegetative state, and if you go up to an individual like that and you apply a noxious stimulation, they can feel it. They can feel pain. And I think, you know, as we try to determine what attitude we're going to take toward them, we need to keep that in mind.
I personally feel that starving someone to death who can feel pain is cruel and unusual punishment because starving is not a comfortable sensation. And, you know, it never has really been much of a problem in the practices where I've been involved because people get urinary tract infections, they get pneumonia, they get various things that don't have to be treated, and it's a much more humane way of allowing someone to go than actively starving them to death.
Now, having said that, I had a case just this Monday of a family who brought to my clinic a four-year-old boy, a young mother and father and a grandmother, who had a malignant brain tumor, had been operated on elsewhere twice, and had been given a course of chemotherapy. The tumor progressed through all that.
The child was laying there on the exam table, wasn't moving any extremities even with noxious stimulation, gave no indication of interaction with the external world, although the parents assured me that he could hear and that he could respond. I called the oncologist who assured me that he couldn't and about all of things that had been done, which were very different than what the parents were saying.
The point being that a lot of times the advocates for these individuals hear and see what they want to hear and it may be something that's very different than reality. And, you know, part of, I think, what the practitioner, the good practitioner, has to do is to be able to ferret out fact from fiction and help the surrogates to understand that. And when they have a much better understanding of what's going on, then sometimes they can act, I think, in a more rational fashion.
What I, in fact, told that family is that because this child was paralyzed, was unable to move, that even if we could make all the tumor disappear, because that child had been in that state for several weeks, that the central nervous system would not work and therefore the child would remain in that type of state. Well, they hadn't heard that before and there was some weeping and wailing and gnashing of teeth, but I think they came to an understanding at that point.
And sometimes, you know, it's very difficult. You feel like the bad guy when you have to tell people what the facts are. But in many cases I've seen medical practitioners who don't want to be the bad guy, who don't want to actually give the facts, and that simply prolongs the emotional distress in the long run. It's probably better to go ahead and be honest with people.
There's another case of a 12-year-old that I think I've talked about here before who was in an automobile accident, severe multi-system trauma, including the central nervous system, and, you know, I told the mother in that case that if we pulled out all the stops, if we did everything known to man, that we could probably save this child, but that the result would not be a good one. She would never walk, she would never talk, she would have very, very little interaction with the world. And the mother said, "Yes, I'll take it."
That was nine years ago. I see them about once a year. And exactly what we predicted is what is there. The mother is delighted. I don't think that the patient is. And, you know, I have to wonder in situations like that are we correct as practitioners when we are willing to pull out all the stops?
Maybe the mistake is even making the offer to pull out all the stops in a situation like that because a lot of times people cannot act in a rational way when you're dealing with their loved one. This is something that I think needs further discussion in terms of doing what the patient wants done and ignoring our medical knowledge.
Just yesterday I was talking to a colleague who had a woman who had a herniated disk in the thoracic spine that had herniated anteriorally, so it was going to require a transthoracic approach. A preoperative chest x-ray demonstrated a spot on the lung. A subsequent CAT scan demonstrated that it was likely to be an aggressive tumor of the lung, a malignancy. The patient didn't want to hear about it.
She said, "Just do the operation. I don't want to hear about any cancer. My mother and father and several relatives have died of cancer. I just don't want to hear about it. Just take out the disk." Now, what should he have done, you know, in a situation like that? Still to be determined.
Obviously the case they canceled and further consultation done, but obviously him needing him to do a transthoracic approach in someone with a malignant brain tumor, that could have real serious implications for that patient's longevity.
Now, in thinking about what is futility, I think most of us would agree it's not futile if something has a 50 percent chance of succeeding, but what if it's a 10 percent chance or a 1 percent chance or one-tenth of 1 percent? And I guess what we're asking when we ask those kinds of questions is what is the value of a human life and how much are we willing to sacrifice in order to save it?
Now, it's easy for us to sit around and say, "Well, let's make it one in a hundred or let's make it one in fifty," but what does that really mean? You know, if we go back historically and we look at hydrocephalus, a condition that we're able to treat quite effectively these days, but go back 50 or 60 years and you're dealing with that one in a hundred situation. The same thing with myelomeningocele, spinal bifida. You know, what if we go back many years.
We don't have to go back that far for a disease like megaloblastoma, a malignancy seen primarily in children in the posterior part of the brain. Dismal results. What if we had said, you know, "They all die. Why should we bother to continue working on this? You know, only 1 in 100 of them survive." Well, now, there's an 80 percent, five-year survival for megaloblastoma because of a lot of hard work that's been put into it.
So this is not to say that it isn't important to look at the numbers, but I think it's also important to look at whether, in fact, there is increased understanding of what's going on and maybe to re-look at things periodically.
That was certainly the case with hemispherectomies, an operation we use to control intractable seizures in children. And when I was first approached about doing a hemispherectomy in 1985, you know, the operation had fallen out of favor because of the high complication rate.
But in looking at the reason that there were so many complications previously, you know, there had been a number of advances. So we started doing hemispherectomies again and, you know, everybody does them now because we started looking at a problem that had been sort of written off in light of new knowledge and new technology.
So I think that's something that we always have to keep in the equation, because as we advance as people in medicine and science, that's going to change. We have to be pragmatic when we look at these things. Obviously there's only so much money, so many people, so much in the way of resources to go around, so—but if we try to save everybody or if we try to save no one or if we come up with something in between, we're still going to be wrong sometimes, no matter which of those philosophies we decide to choose.
So I think we really do need to be looking at practical guidelines, but we also need to recognize that people should have the option of opting out in exceptional situations.
CHAIRMAN PELLEGRINO: Thank you very much, Ben. And now I'll ask Dr. Daniel Foster.
DR. FOSTER: I'm going to say two things here. You'll probably say I'm biased about the first one, but I want to begin by a defense of medical professionalism, which is sometimes called paternalism or dogmatism, and to do that I want to turn to the experience and testimony of the late Dr. Franz J. Ingelfinger, who was the distinguished editor of the New England Journal of Medicine, himself a physician/scientist who worked on esophageal carcinoma.
He gave the George W. Gay lecture at Harvard on May 5, 1977, which had to do with ethical issues. And at the time he had been diagnosed with the same cancer that he had studied—that is, an esophageal carcinoma. When he died, the lecture was found in his files and the other editors of the New England Journal decided it was worthy of publication and they published it on December 25, 1980, after his death.
And I want to cite several citations from Dr. Ingelfinger. When you're the editor of the New England Journal of Medicine, everybody in the world knows who you are and you will see what that says. He began his lecture with a general statement about the role of the physician and then turned to his own experience with his esophageal carcinoma.
He said, "If the physician is to be effective in alleviating the patient's complaints, it follows that the patient has to believe in the physician, that he, the patient, has confidence in his advice and reassurance. Intrinsic to such belief is a patient's conviction that his physician not only can be trusted, but also has some special knowledge that the patient does not possess. He needs, if the treatment is to succeed, a physician whom he invests with authoritative experience and competence. He needs a physician from whom he will accept some domination.
"I'll go further than that," Dr. Ingelfinger said. "A physician who merely spreads an array of vendibles in front of a patient and then says, `Go ahead and choose, it's your life,' is guilty of shirking his duty, if not malpractice.
"The physician, to be sure, should list the alternatives and describe their pros and cons, but then instead of asking the patient to make the choice, the physician should recommend a specific course of action. He must take the responsibility, not shift it onto the shoulders of the patient. The patient may then refuse the recommendation, which is perfectly acceptable, but the physician who would not use his training and experience to recommend the specific action to a patient or in some cases frankly to admit `I don't know,' does not warrant the tarnished but still distinguished title of doctor."
Then he turns to his own case, to testimony, to illustrate what he said in the generic statements. His esophageal carcinoma was growing. "The current medical practice is to assume that the patient who has an operation for any of a variety of cancers, including the type I have, should also be given prophylactic treatment in an effort to eradicate the micro-metastases, the tiny metastases, before they enlarge.
"For this purpose both chemotherapy and radiotherapy are being used extensively. So one question was, `Should I have chemotherapy with all its side effects, and if the chemotherapy, what kind?' Even more debatable was the question of whether I should have radiotherapy. Radiation would involve for me a number of complications, such as fibrosis of the lungs, scarring of the lungs, and the possibility of a host of less frequent, but nevertheless serious side effects.
"At that point I received from physician friends throughout the country a barrage of well-intentioned, but contradictory advice. The question of prophylactic radiotherapy was particularly moot. As a result not only I, but my wife, my son and daughter-in-law, both doctors, and other family members became increasingly confused and emotionally distraught.
"Finally when the pangs of indecision had become nearly intolerable, one wise physician friend said, `What you need is a doctor.' He was telling me to forget the information I already had and the information I was receiving from many corners and to seek instead a person who would dominate, who would tell me what to do, who would in a paternalistic manner assume responsibility for my care.
"When that excellent advice was followed, my family and I sensed immediate and immense relief. The incapacity of enervating worry was dispelled and I could return to my usual anxiety, such as deciding on the fate of manuscripts or giving lectures like this."
And then he—the title of this paper, I forget to tell you, was "Arrogance." And he's contrasting two arrogances. The arrogance of expertise and then the traditional form of arrogance, and this is how he finished.
"If arrogance in the sense of paternalism and dominance is an ingredient of beneficial medical care, these qualities have to be used appropriately. To the extent that paternalism and dominance are infected by some of the other meanings of arrogance, a physician's conduct with patients is correspondingly worsened. Thus if his paternalism is accentuated by insolence, vanity, arbitrariness, lack of empathy, the care he attempts to provide his patients is nullified."
In other words, a physician can be beneficially arrogant or he can be destructively arrogant. Now, I'm absolutely committed to and un-defensive about beneficent paternalism. I think everyone should want a true physician, which I defined in a lecture last week to the Texas Academy of Internal Medicine as follows: A true physician is one—the implication is that there are some physicians that are not true physicians. There have been pirates in the system from antiquity, but a true physician is one who is continuously and changingly competent, who throws self into the battle against disease and death without reserve, who fights equally to relieve symptoms when cure evades and who is characterized by a constant, unbiased, non-contingent kindness to everyone he serves under care.
John Stone, the poet and medical philosopher at Emory, just died. He was a wonderful, wonderful man. I have a book he dedicated to me. The first two sentences in his book In the Country of the Heart are these: "Every human is born with two hearts. One is the fist-sized pump that pumps blood and on the chest x-ray appears like a ghostly shadow, but each of us also has a metaphorical heart, which pumps nothing. It is the seat of compassion and kindness."
And every true physician has a metaphorical heart. And as a consequence, they wish to do the best for their patients in the ICU or wherever it is. And after more than 40 years I have a high view of the importance of the true physician's guidance to the patient under care.
Now, this is, as he said, does not mean that the patient has to follow the advice, nor is there any—there's a demand to talk with the families and the patients. It's hard these days when people come to emergency rooms and nobody knows them and you have a doctor who comes in and you have to make very quick decisions, but I think almost everything that I have heard hinted at in the futilities and so forth has to do with the fact that one of the big problems is the physician making medical decisions.
Now, any patient will know a lot more about her feelings than I do and maybe knows a lot more than I do in many things, but she does not know more than I do about medicine. And I will not back off. She does not know what I know about medicine. And I think it also is a failure to meet the demands of the physician if one does not do this.
It has nothing to do with trying to understand the patients, although I raised a question earlier, which I think is a very real one, that very sick people—and particularly if they have alterations in the way they think because of their disease—it's a little hard to understand what they say they want for them is truthful. That's the first thing.
And then much shorter I want to say just a word about futility decisions. I think our medical school in our public hospital may be different from—we have had almost no conflicting futility arguments—almost none. And I think that's because we've done pretty well about communicating with the patients, even though many of them are poor and desperately ill.
There's one of the statements that was made in the paper this morning about thousands of futility decisions made in Texas. I'd be very skeptical of bigger hospitals, very large, and they're serious with 49 or something like that. We have not—any maybe we just ignore it. I don't think so because a lot of the patients come in from the background that was— Dr. Rubin talked about. They're minorities and so forth.
So what I want to say about futility and about the policy is that I think we should be slow in activating futility decisions. You may—we shouldn't make those quickly. Let's say that a person with acute leukemia comes in and the prognosis is that she's got six month to live, but she's got acute pneumonia.
Well, we can immediately—we're not going to say that she's got a futile illness, she's going to die pretty quickly, everybody knows she's going to die. We treat the pneumonia so that she can have better months, better life for the time to go. So quick decisions should not be made.
Now, my most recent was with a patient that I've cared for for more than 20 years. She's had multiple complications of diabetes. She's one of the most wonderful women that I ever knew. She's an African-American member—person who worked in the laundry at Parkland Hospital, and I take care of her sister who is a registered nurse. But she's had all the multiple complications of diabetes, but she was so upbeat and everything.
Every time I'd see her, I'd say, " Ms. H., how are you?" She'd say, "I'm blessed." "Well, Ms. H., you're now legally blind. You can't drive anymore." "I'm blessed." "Well, Ms. H., now you've got renal failure and we're going to have to put you on dialysis." "I'm blessed."
In fact, one day I came in. She said, "How are you, Dr. Foster?" And I said, "I'll tell you what, Ms. H., I'm really good today and you know why? Because I'm blessed to see you." Now, I was good for her.
You know, it's like Kierkegaard 's "like for like." I mean, I did—until the end of her life, I took care of her in the nursing home and—I mean, she lived at home with the home care and so forth. But what you give, you get. That's what Kierkegaard says, "What you give, you get." And she was so great to me.
Well, in the last year and a half I got called driving down the toll way one morning at 6:00 o'clock. She's had—in addition to these complications, she has had two upper GI hemorrhages, she's had three strokes, and two and a half months ago she came in to—she goes to the University Hospital because nobody in her family has insurance.
And she had endocarditis and it's with a methicillin resistant staph. I mean, that's a very resistant staphylococci. We treated her daily for two and a half months. And it was a really resistant bug to Vancomycin and everything else. And then about a week and a half ago she threw an embolus to her leg. It was a septic embolus, and she got gangrene in the leg. So it was turning black.
In any other circumstances we would have amputated. Then I talked to her daughter Kathy. Her daughter was just wonderful. And here's what she said to me about whether to operate. I thought she would die during the surgery, but here's what Kathy told me. She said, " Dr. Foster, my mother loves you, and she would want you to make the decision about this, a small chance that she would live if we—and I want you to make the decision, too, because of the trust which is there."
And I decided that she would not survive it, would die of it, and as a consequence it was futile. And she died quietly two days later. When I went there, her sister was there, the nurse, and so forth, and what they—you know, what they said to me, "Not that you're paternalistic or dominating, what you did was help us and we want to thank you." Wilma, the nurse, was crying and so forth, but—and that's when I told them about the "like for like," how Ms. H. had done probably as much or more for me than I had done for her.
Now, my point is that I have a high view of physicians. I think most of them are true and want to do things. They're not money-hungry people and all that. Osler said the same thing. I think it was September 17, 1902. He said, "I want to speak to certain features of your heart," and he talked about four things—the noble ancestry of true physicians, the remarkable solidarity to try to solve—to treat disease and make the knowledge available so other doctors could do it, to have a progressive mind set so when new things occurred that you would learn them. You have to be a life student. And then his last thing was they have—"True physicians," he said, "have a singular beneficence. The sum total of suffering relieved by physicians is such to make the angels sing."
So I just wanted to say a word about what I consider to be a noble profession, and I think it's a very lucky thing if you can have a doctor who cares for you and knows what in the world he or she is doing. That's what I said to the Texas Academy. I said, "What I've been trying—I've talked about true physicians." I said, "What I've been trying to say is that we ought to be the kind of doctors that when the time of reckoning comes for us or for our family that someone like you will take care of us."
CHAIRMAN PELLEGRINO: Thank you very much, Dan.
PROF. GEORGE: Well, Dan that was very, very beautiful and so much truth and wisdom in it that I'm tempted simply to sit back with the rest of our colleagues here and admire. But I do have a question. I don't think there's any doubt that in the poignant story you told in the treatment of your patient and your discussions with her daughter that the decision that you made and the decisions to which the daughter deferred saying that her mother would defer to your judgment was a medical decision. I don't think there would be any controversy about that.
You made the decision based on your best judgment, which was informed by your medical training and experience, that she would not survive the operation. So I don't think that—I don't think anyone around the room would consider that to be a controversial case, but consider that anything that you did or that they did was anything more than admirable. They deferred where they should have deferred, to greater expertise and knowledge.
And, of course, they were made much more comfortable in that by their long relationship with you, and wouldn't it be wonderful if we all had those kinds of relationships with doctors when, you know, the time comes, if it does come, when we're in those situations including, as the other story you told, felt even those of you who are doctors who also would need doctors.
But it seems to me that in the discussions that we've been having, not only at this meeting, but at some other recent meetings, the interesting and difficult questions come when we run into controversial areas about what constitutes a medical decision, where there are competing points of view, not only in society at large, but even within the medical profession about what constitutes genuinely a medical decision.
While it's clear that a decision about whether a patient is likely to survive a particular operation is a medical decision, it's not clear—or perhaps I should say it's clear that it's not a medical decision where someone is making a decision about whether a life in a particular set of conditions or a life living under a certain set of conditions, like in a persistent vegetative state or a minimally conscious state is a life worth living.
When we move into the question not of whether a particular treatment is likely to be useless in sustaining life, but rather into a question about whether the life that would be sustained is a burdensome life or a life worth living, then we're into the area that I think gives so many people—I'm one—so much trouble, so much worry.
Now, there might have been a time—I don't know—there might have been a time when a broader social consensus supporting a consensus within the medical profession itself around, perhaps, the norms of Hippocratic medicine, would have made it possible for us simply to defer to doctors when, according to the consensus, the decision being made really was a medical decision.
But it seems to me that social consensus, if it did exist, has broken down and certainly the consensus around Hippocratic medicine has broken down. So what I wonder about is whether the kind of deference that you would like to see or the kind of paternalism—and I don't use that pejoratively, as you didn't use it pejoratively—whether the kind of paternalism that perhaps once could have been practiced without controversy by doctors is any longer possible or desirable? And that's my question.
DR. FOSTER: Well, my own view is that these sorts of issues come up with—not the medical decision, per se. I mean, it usually comes when somebody has to be fed or somebody is totally unconscious. So I—I heard today that some people are talking about Alzheimer's or dementia being a futile thing.
I think that the majority of physicians would not do that. I mean, we treat patients with Alzheimer's disease just like we treat children with Down syndrome or even much worse things, like progeria and so forth where these kids are dying at three years old because they look like they're 90 years old when we do it.
So the fundamental issues have to do, I think, with these long-standing—that's why I said don't make quick decisions about futility. Now, I don't know what the calculus is. We heard something about maybe there are 30,000 people in this state. I don't know whether these figures are exact or what.
I would say that it might be that in rare circumstances that somebody could argue that there's a strong religious or other reason why somebody should be kept alive who has, as far as we know, no working neurons and so forth and so on, and one might make a judgment that a small movement from—with single patients for feeding and so forth is not worth the pain going through.
Now, for some physicians, this is a matter of conscience. That's what we're talking—you know, we've had all this argument about what about a physician who doesn't want to do abortions or things of that sort. And there are persons who genuinely—you know, true physicians who believe that that's not an acceptable life for somebody else.
So I can't answer your question. I don't think anything—most ethical or moral decisions are grey, not black and white. And so I would be the example of the—somebody trying to stay alive until a grandbaby was born. I mean, I'd be perfectly willing to extend a life under, you know, those short-terms things. It's not even an issue to me. It's the long-term things.
Where the courts are in general saying that—have generally said in these argumentative things that you could withhold things. So I see your point. What I don't see—I don't know, I'm trying to figure out sometime how many thousands of patients I've seen, a huge number, poor, in Parkland Hospital and so forth, and these decisions—these are newspaper decisions where—just like the little boy in Texas. Those things are where the real conflicts come.
The ordinary dying in an intensive care unit and so forth and so on doesn't involve this. In fact, as you say, I was taking care of the mother of one of our pediatric full professors, and we agreed that she had nothing to do, I discontinued the intubation, and I thought that—like most of the time we put them on oxygen—a T-bar with oxygen, I thought that she would die within a few hours.
And she kept living and living and living and living and living. And when it got to be about the eighth or ninth day, her daughter says, "You've got to do something." And I said, " Joann, I can't kill your mother. I can't kill your mother."
Well, fortunately, you know, on the tenth day she died, but you can't—you know, you can't predict all these things, and very often the family wants mercifully to let their mother or father go.
I'm not answering your question very well. I see your point, but I think it's these TV news and newspaper stories that generate, but day-to-day in big hospitals, these are minor in my opinion, at least from my experience. I don't know whether that answers your question or not.
PROF. GEORGE: Well, it's helpful and valuable, but I see this underlying problem going far beyond simply end-of-life issues, and it's not just because of the publicity surrounding some very high-profile, end-of-life issues.
Take the case of Down syndrome and abortion in the case of Down syndrome fetuses. We learned recently—at least the public was told that in 90 percent of cases where the unborn child is diagnosed with Down syndrome an abortion takes place.
Now, I don't know what goes on between doctors and the women that they're treating in those circumstances, but is and should the medical profession treat Down syndrome as—abortion in the case of Down syndrome— as a medically indicated abortion or not?
I mean, it seems to me there's no consensus on this. It's not something that can be resolved by scientific knowledge. One's expertise by virtue of one's medical training and experience is of no help, gives one no advantage over other people who are not physicians in understanding that.
But plainly there are some people who have the view that medicine, as such, has something to say about an issue like that. And that's just one example. We could talk about so many, some that came up when we had in front of us the representative of the ACOG Bioethics Committee that had issued their report on conscientious objection. It seems to be a problem across so many fields of medicine.
And as I mentioned earlier, and now I'll stop, it seems to me to reflect a larger breakdown in social consensus, the moral consensus of society, from which it's no surprise that the medical profession is not immune.
DR. FOSTER: Well, I don't think that's a medical problem. I can answer—I mean, there are a large number of people who are against abortion for any reason, even fatal and so forth. There are others who think that that's an appropriate thing to do with genetic pretesting and so forth.
In addition, from my medical standpoint is, that most kids with Down syndrome not only are happy and healthy for a good period of time, but oftentimes the most beloved—it's a problem sometimes that you love the Down syndrome more than you...
So to me I don't think—I'm just speaking personally. I'm not speaking for medicine; I'm not speaking—I'm not making decisions for women. And so if you just asked me personally, I think that was not—the next volume we're coming up is about testing in children, and one of the main views is, you know, should—the traditional view was whether you only test for diseases for which there is a treatment or for which there is a deadly outcome and so forth. Well, Down syndrome is not a deadly outcome.
Now, if I'm—I don't have religious feelings about this at all, but if I had—and I'm not speaking for my wife either, but I suspect that if we had a Down child coming along that we would be delighted to have that child. We'd be sad about the fact that he couldn't go to Princeton and have you teach him or something, but that's—that's the answer to your question.
I think that this goes over into other things where you want to—it becomes almost like our enhancement that we're going to do—what I would like to do, and I'll use anything in the genome that gives us information about a disease that's terrible and deadly, but we shouldn't try to make perfect babies here with things that might never happen.
And we talk about that with enhancement, you know, to make them smarter. I mean, somebody might argue to abort somebody that looks like—if we ever had a mark for intelligence and something, that you'd do that.
So I think there—but what I'm trying to emphasize here is that in ordinary, day-to-day medicine that's going to affect all of us here, these problems are not as great as they have—in my view have been raised to be.
So that's the only thing, because I'm like Ingelfinger. If I get sick, I'm going to get a doctor that I not only trust but knows something, and I don't want to get a doctor who I could trust and doesn't know something, and I don't want to get a doctor who—those two things are just—
CHAIRMAN PELLEGRINO: Thank you, Dan.
DR. FOSTER: Ben, I've been doing all the talking. It's your turn now.
DR. CARSON: Okay. No, you've done quite an adequate job.
CHAIRMAN PELLEGRINO: Dan, would you have anything you want to add? I have three asking to speak— Dr. Schneider, Dr. Elshtain, and Dr. Hurlbut, in that order.
DR. SCHNEIDER: I found these last two talks some of the most helpful that I've heard while I've been a member of this group because they give some sense of the nasty complexity of the way that people live and the way that doctors and patients deal with each other and because they are so useless in helping us find a rule that will solve all of these sorts of problems.
And I think that—I increasingly think that the search for rules that will give us a good handle on how these problems ought to be solved is a hopeless search. It is at least, I think, a search that has no longer any prospect of finding help from the standard categories of bioethics—the autonomy principles and the shared decision-making and the informed consent and all of these kinds of ideas—because they are simply too schematic to be helpful in thinking about how real people live their lives.
Let me give a few kinds of examples of that, starting with a story of my own experience with an endodontist. I went to him and I said, "So my dentist tells me I'm needing a root canal." And he looked at the tooth and he did the things he does and he said, "Well, now, here are the facts of your case." And I said, "That's very interesting. Do I need a root canal?" And he said, "That's your decision."
And I said, since I've been teaching this for 20 years, "Yes, I'm aware of that, but do I need a root canal?" And he said, "No, it really is your decision because your values might be different from my values. So what good would it do me to give you any advice?" "I have no values that are relevant to this question. And I've been teaching in this area, as I say, for a long time, and I don't want to develop values that are relevant to this question and I don't know how I would go about doing it."
People actually don't come equipped with a set of values even when they're 60 years old. They have very spotty values about some kinds of things and most of the time when they're making a decision, they're not making a decision by saying, "Here are my goals, here are my values, and this is the best way of achieving them."
They actually discover what their values are in the course of making the decision. And it is only really in the process of trying to explain to themselves what they have done that they find that they have some values that they now claim as their own.
The evidence is not only that people don't come equipped with values and they make their values up as they go along to explain the decisions that they have reached; there's a lot of evidence that people have a great deal of difficulty in figuring out something as simple as how they're going to feel in some imaginable future state.
People who have difficulty in anticipating how they're going to feel if they become paralyzed, for example, are quite notorious. They predict very inaccurately because they focus on only a small part of the life that they would be leading if they were paralyzed, and they don't think about the things they would still be able to enjoy doing, and they don't think about the things they would do to try to work as psychological defense mechanisms.
So people go to doctors, and the standard routine is that they have their values and the doctor gives them the information and they make the decision. In fact, I think doctors often have a lot of useful things to say about what your values ought to be.
I remember reading the description of one professor at Rice who had prostate cancer who went to a surgeon and said, "Now, surgeon, let me tell you what my values are. I have three priorities. Staying alive is the first one. Avoiding impotence is the second one. And avoiding incontinence is the third one. And that's the order in which my values are arranged."
And the surgeon said, "You're wrong about your values. You don't know what you're talking about, because you haven't thought very carefully about what it is like to be incontinent and how much of your life would be injured by that, including, probably, your sex life."
And the professor said, "I realize that I have been thinking very incompletely about this and that I didn't actually understand what I wanted or what my life would be like." There's a classic example of this where there's a fair amount of evidence.
People who are told that they need colostomies commonly—quite often say, "I would rather be dead than have a colostomy." And the evidence is that doctors understand better than the prospective patient what they are going to feel after they have had their colostomies. So doctors and people who have had colostomies have one set of ideas about what they're like, people who are presented with the possibility of getting them have another set of ideas.
So doctors have, if they are acute human beings, learned a lot by watching people go through the trajectory of illness and have helpful things to say or can have helpful things to say about what kinds of preferences you might want to have about illness.
Now, the trouble is, of course, that there are a lot of bad doctors, there are a lot of doctors that are bad in the arrogant way—in the bad arrogant way. Jake Haps just died. Jake Haps said very important things about things that were wrong with the way that doctors and patients dealt with each other. But the question is—are there any rules you can write that are really going to fix that problem? And I increasing think that the answer is that there are not rules that you can write, there are not principles you can invoke, and if there are, they're certainly not the ones that have become so standard in our discourse.
CHAIRMAN PELLEGRINO: Thank you very much, Carl. I have Prof. Elshtain, Hurlbut, and McHugh.
DR. ELSHTAIN: I actually have a quick question for Dr. Carson, then a slightly less quick comment for Dr. Foster. I won't take—and I won't take very long. Dr. Carson, in your very interesting presentation you mentioned the case of the 12-year-old girl who had been in the catastrophic automobile accident and you said, what, nine years on or something from that, that the mother was, in your language, delighted, but you weren't sure about the patient. And I wondered if you could elaborate briefly on what you took to be the source of the mother's delight and your concern about the patient.
And I'm going to go ahead and, Dr. Foster, it strikes me that the case that you described, your interaction with the patient over time, was quite the opposite of—and others have mentioned this—but of paternalism or domination in the way it's usually thought of.
And it strikes me we shouldn't want to resurrect or defend the language of paternalism or dominance, that there's another way to talk about what you described. We could talk about the legitimate authority of the physician based on his or her competence, which seems to me is rather different from talking about something like dominance.
And we could talk about the process of sort of healing and a relationship with a physician that has healing dimensions in it insofar as there's deep trust. And that also seems to me quite different again from some of the older notions of paternalism and dominance.
So I don't think that's what you were describing at all, actually, that the language of dominance comes from, you know, the Latin term for an absolute master— dominus. So one who engages only in monologues, to use Dr. Rubinstein, but never in dialogues, and what you described was a dialogic relationship very much all the way through.
So I think we do well to be wary of paternalism when we see it. Even as we—and I think there is that. I mean, I, myself, have encountered it. I think we'd also do well to appreciate the competence of the physician and why we are well-placed to have some confidence in that and in the authority that comes with that.
So I think we need a way of talking that doesn't try to resurrect some of these older notions. That was my only—
DR. FOSTER: Ben 's will be a much—and I was not defending dominance or paternalism, just that it was mentioned in almost every thought we heard today.
DR. ELSHTAIN: I know.
DR. FOSTER: So it's not as though it's disappeared. It's used as sort of a pejorative term. So I was only answering that in the sense of trying to answer this—
DR. ELSHTAIN: And what I'm suggesting following on from that is that we don't want to try to resurrect that language to get at what you're talking about because that strikes me that that's something very, very different and something extraordinarily valuable that you described.
CHAIRMAN PELLEGRINO: Dr. Hurlbut.
DR. ELSHTAIN: Wait, Dr. Carson has a question I asked.
CHAIRMAN PELLEGRINO: Oh, I'm sorry.
DR. CARSON: You know, the mother—obviously I can tell that she's happy because every time I see her she's got a big smile and she's full of thanks for the fact that we were able to keep her daughter alive. And that's understandable to a certain extent if you're looking at just the fact that a person is alive and hasn't left us.
As I frequently tell families after someone has died, "You know, the person who died isn't suffering. It's those who are left behind." And that's where the suffering comes in. You know, as far as the girl herself is concerned, she's worked out a means of communication with eye blinking, but to be a 21-year-old who has experienced the world that way—you know, I don't have any way of knowing for sure whether she's miserable, but, you know, I certainly think that I would be.
And sometimes I think that we as medical professionals can avoid such situations by not necessarily laying everything on the table. It's sort of a situation where, you know, we might want to give ECMO to too many patients. While a lot of those ECMO patients we could probably save, but to what end are we saving them? And I guess, you know, that's more of an ethical question than some of the other things we've been talking about today.
CHAIRMAN PELLEGRINO: Dr. Hurlbut.
DR. HURLBUT: I want to say how much I agree with your overall perspective on the importance of the physician as a trustable and decisive aid to the patient, assistant to the patient, but it strikes me, as was pointed out by speakers implicitly and one explicitly, that this dilemma is partly a product of modern biotechnology and it's just one of the edges, and there are many coming, offering us things that are not traditional uses of medicine and with strange extensions of medical purpose and so forth.
And so it strikes me that your affirmation will become increasingly important, not in any way less, as people know more and think more, and have more diversity of views. I think our whole purpose for taking on this project of professionalism in medicine is partly because we all intuitively realize that we're entering an era where doctors need to not just be good individual physicians to individual patients, but we have to reaffirm, reestablish, and clarify what medicine is and the role of medicine.
That's a larger kind of trust. And it comes back to what Jean was saying about there being—I can't remember the exact word. Was it truth warrants or something? Truth warrants. We need to not just lay this open to what was rightly decried as mere autonomy.
We need to have an input into this, because it's true that we aren't just pure insiders with our own—it's true that we are insiders to some extent with our own perspectives and our own medical culture and scientific culture, but we're privileged insiders in the sense that we're among the few people who actually get to see case after case after case.
And slowly, like so many things in life, as you see it, you begin to sift it and make sense of it. And so I think what has been decried as paternalism can be relabeled—what the term is I don't know exactly, but something positive.
Physicians have a practical, personal encounter with a very reality-grounded kind of experience on which to base their judgment, and so in that sense the physician that Dan laid out—the image of the physician was not—not only a physician with a breadth of personal experience, but one who places himself within a tradition of medicine.
And the common sense that was referred to quite a few times implicitly and some explicitly, especially in the first presentation—that common sense is not just the common sense of a one-moment in culture, but common in the sense that it crosses time and culture.
And I feel strongly that we need to address Robby's concerns. We need to start re-rooting ourselves in where medicine came from in the first place, what it is, what it means to be part of a profession that has been around for a long, long time and one that has over that time developed a coherent vision of what it is for.
And here's just a couple of things I think it's for, and then I'll stop here. We need to remember that you can take some lessons from nature. You can draw on what you feel intuitively through human experience, but also seek a coherent understanding of what nature itself tells us, namely that there are eminent powers in the body ordered toward health and healing, that suffering is a reality that we have to make coherent with our—not just our medical care, but our larger purpose and sense of life and the implicit limitations on the prerogative of human interventions. These are just three.
And maybe they're all summed up and I think crucially grounded and this is partially—part of an answer to Robby's concerns. If we would return to the core of our profession, we would return to the principles that are laid out in Dr. Schneiderman 's paper, and I quote these just to end.
"We started with the premise that physicians are obligated to offer only those treatments that have a reasonable chance of achieving a therapeutic goal"—I put the emphasis differently, but a therapeutic goal. And then he also went on to say, "We are a healing profession committed to helping and serving the sick."
And it's because of those things that I personally, at least, have clarity about some things I will not do as a physician. If we would root ourselves in reality and an understanding of nature and across time and culture, I think we'd understand our task better and serve our society better. We'd both provide both a better sense of purpose and a better sense of principles on which to operate.
CHAIRMAN PELLEGRINO: Thank you, Bill. Paul McHugh.
DR. MCHUGH: Well, I'm not sure I can add anything to this very wonderful conversation that started with Ben and Dan and Carl and others. I do want to perhaps choose a set of words of interest that a psychiatrist has for these matters.
Fundamentally a psychiatrist is very interested in how anyone develops moral agency, if I can use that word. How do we grow from being these little selfish bundles of flesh that come into this world into people who have moral concerns for others and think coherently about it, even when we disagree with one another?
And that's a subject of great interest to me as a psychiatrist because I'm interested in behavioral disorders. And if you're interested in disorders, then you're interested in what's normal. And normal is big when it comes to behavior.
And I think I'm speaking really to what Carl is saying, but I want to come back to what Robby was asking of Dan, because it was the issue of where do you guys get this moral posture that you use in the care and treatment of these patients? And my answer to it is we get it from our practice.
Medicine is a practice. It strives to deliver understanding of diseases and their treatments to human beings like each other. In that process of doing that, in practicing that, we begin with simple rules that are taught to us by our teachers, like Dan and the teachers that taught me, but gradually as we practice it more and more and have the experience of seeing the consequences—not simply the consequences physical, but the consequences psychological, the consequences social, the consequences and the like—we begin to develop a certain set of moral attitudes that have interesting features to them—that is, that they are—that they're not always completely in agreement with what's the standard views.
They're not always necessarily in complete agreement with each other, although we know we have coherent experiences together, but ultimately that we come to a place where we have a certain authority. Why wouldn't you think that moral truths wouldn't come to us out of these experiences?
We wouldn't say that they're the only moral truths, that they wouldn't be in conflict with other people in a pluralistic society, but where moral agency comes is from the practice of us all, what practices we choose, and if you want a normal person and bring up a normal person, one of the things is, "Gee, have a quest for something," and in that process of that quest, you will not only learn big moral issues, but, you know a lot of things will be—you'll decide them on the spot.
You won't have to think about them. It just becomes natural to you. You're not going to kill that person, you're not going to do these kinds of things. And medicine isn't the only practice. Our scientists learn the same thing working in their laboratories. They begin with physical things, but they ultimately come to talk about truth, the meaning of community, the meaning of laboratory issues, and ultimately the inspiration of other people to join them in this way.
So, I mean, that's a long way around to say my interest and the interest in relationship to our work today is how do people develop moral agency anyway, and they usually do it through practices and some of the practices are professions like medicine.
CHAIRMAN PELLEGRINO: Thank you very much. We will meet tomorrow at 9:00 a.m.