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Thursday, November 20, 2008


Session 2: Medical Futility

Robert D. Truog , M.D. Professor of Medical Ethics, Anesthesiology and Pediatrics, Harvard Medical School and Children's Hospital, Boston

 

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 life 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.

[Applause]

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, clearly 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 .

[Applause]

 


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