THURSDAY, December 8, 2005

Session 2: Ethical Issues in Neonatal and Pediatric Intensive Care

Robert M. Nelson, M.D., Ph.D.
The Children’s Hospital of Philadelphia

CHAIRMAN PELLEGRINO:  Our next speaker is Dr. Robert Nelson.  Dr. Nelson is Associate Professor of Anesthesiology and Clinical Care at Children's Hospital of Philadelphia, and a Senior Fellow, Center for Bioethics, the University of Pennsylvania.

He has his bachelor's degree from Wesleyan in chemistry — he and I share that — an M.D. and M.Div. from Yale, and I had the good pleasure of knowing Skip when he was a medical student at Yale, pursuing a double degree in the School of Religious Studies as well.

He is occupied now, and moved very, very fast in the field of bioethics, particularly in intensive care, but still ranging over a whole series of issues of the kind we'll be looking at.

I've asked him, as I've asked the other speakers, to feel free to range over the problems of pediatrics, but to try to concentrate as closely as possible on his area of expertise. 

Skip, welcome to the Council, and it's all yours.

DR. NELSON:  Thank you, Ed.  And in case people haven't figured out, Skip is my nickname.

(Laughter.)

Which I've had since a little child.  And, actually, an anecdote on that — when I was a medical student, was asked what to put on my name tag, I wrote down "Skip Nelson."  And the Dean of Students at the time vetoed it, because he didn't think that was professional.

Immediate identity crisis, nevertheless.  And I've kept it.  So I went into pediatrics, so I don't have to apologize for the fact that that's my nickname.

I'm certainly honored by the privilege to speak here, and certainly by the task of speaking and even using some of his own work in front of one of my mentors, Dr. Pellegrino, with whom I took a reading course back in 1976, the summer of 1976 when he was President of Yale New Haven.

And then, the daunting task as well to follow Norm Fost, who sets a tough mark when it comes to remarks, as far as in the field of ethics.

Before I start my presentation, I can't help resist but make two comments from the previous discussion, briefly.  The first is, to the extent that you decide to get into things like prematurity or research, there have been committees — for example, the Institute of Medicine, there is a current committee working on problems of prematurity, and there is a report from the Institute of Medicine on pediatric research that came out last year — March 2004.

And I would certainly hope and commend those reports to you to build on if — if the desire is to begin to get into some of those issues.

The second is a comment on Paul Ramsey and the non-therapeutic research.  Two things.  In 1978, he wrote a chapter where he agreed with Bill Bartholome that perhaps the parents' responsibility, or, if you will, authority to nurture the moral growth of their child around assent to non-therapeutic research might be a sufficient benefit that he would admit that that would be inconsistent with what he would call the parental covenant.

In a recent article that Lainie Ross and I wrote in Journal of Pediatrics we suggest the concept of scrupulous parent as a way to try and understand the risk exposure in non-therapeutic research, and would invite the possibility of exploring more broadly what that might mean, and perhaps Paul Ramsey may have had a narrow view of parental covenant, and then perhaps a discussion of parental authority might be a way to begin to ground decisionmaking in non-therapeutic research.

And I see that notion of scrupulous parent functioning the same way as a reasonable patient might in the law surrounding issues of informed consent.  But just as a suggestion.

Now, more directly on my topic — let me just move this closer, so I'm not leaning — I think you'll find that Norm and I disagree about the impact of the Baby Doe regulations, not so much in the importance of what they did at the time but in how they're now playing out in the law.

And I do have Powerpoint.  You have the slides before you, so there is not even — you can choose to look at the screen, or you can look at the printed text before you.

But let me start first with some introductory remarks, and here's the outline of what I'll cover.  Over the last 40 years, there have been dramatic benefits in technology.  I mean, an example for you to consider, the ventilation of newborns with hyaline membrane disease started in the late 1960s.  It wasn't until 1969 that even the use of continuous positive airway pressure for the treatment of hyaline membrane disease was started.

We've come a long way through that time to the 1990s when we developed artificial surfactant, which is now administered routinely, to where the window, if you will, and the discussion of the transition of pre-viable to viable has narrowed to where we're really debating, at least in neonatology, the difference between 23 versus 24 weeks' gestation.

So there has been — whereas if you went back into the '60s, we'd be thinking about the 30-weeker or the 32-weeker.  At what point is neonatal intensive care not worth doing?  The window, because of the technology we have, is exceedingly small as we begin to debate that issue.

The field of pediatric critical care medicine is also even younger.  I was in fellowship training in neonatology, which I did in addition to my critical care, when the pediatric critical care boards were even founded.  When I was a resident at Mass General, Boston Children's didn't have a pediatric intensive care unit.  They started it in 1981, with some areas starting it earlier.

So the field of pediatric critical care medicine is even younger than neonatology.  And there have been dramatic advances to the improvement of child health.  I mean, to give you an example, the morbidity — I should say the mortality of a pediatric intensive care unit ranges four to five percent.  That's it — four to five percent.  Ninety-five percent of the children that enter survive, and the majority of those survive well and survive in a condition that they entered the ICU.

So the statistics, when we talk about issues of limiting or withholding support, we are talking a narrow group of children.  I would agree with Norm about the priorities and the importance of priorities.  What I'm going to be talking with you about is a small group of children. 

There are important issues surrounding when we start technology, the device and drug development you hear about, which normally the two — off-label use of medications, provisions of needed resources, and so forth. 

But what I'd like to focus on as much because I think it's an area that could use your help is the area of decisions around when to either not apply or to stop our technology, issues surrounding either the withholding, not starting, or the withdrawing/stopping life-sustaining medical treatment in pediatrics.  And that's what I'd like to focus on as we move through this approach.

Now, thinking about how to go about this, I often like to start with cases.  But I thought I'd start a little bit with a framework for decisionmaking, and then a brief discussion of two ethical principles, as much so when we get to the cases that I'm choosing to discuss you have an idea of where I'm coming from, as opposed to getting into the cases, you're kind of wondering what I think and what my ethical stance is, etcetera.  I'm just going to lay that out at the start, so through the cases there won't be any confusion, if you will, about my own particular approach.

And with apologies to Dr. Pellegrino, if I have modified how he initially presented this, let me show you how I tend to think of our interactions. I mean, in medicine we establish a diagnosis.  What's the importance of that? 

It allows us to be able to predict an outcome, and then, for that reason, make some kind of intervention or treatment that would hopefully impact on the probability and the assessment — the benefit of harm of that particular outcome.  That's what we do as physicians — make a diagnosis in order to establish an intervention.

Now, as I think about it, the interventions that we have are structured around what could be called the "technical good."  In other words, we make an intervention to reverse a physiologic state, an abnormality of some kind, that we hope, in consultation with the family, is in fact for that child's benefit.

Now, most of the time — as I said, 9 times out of 10, or 19 times out of 20, it's straightforward.  I mean, our technical interventions do, in fact, support the good of the patient to the extent that we then don't need to make explicit that relationship, because, in fact, it works. 

So we don't need to make explicit the value that rests behind that technical good in establishing the prognosis, if you will, or the outcome.  It just is implicit and doesn't need to be made explicit.

The problem is when that isn't the case.  When there's no immediate relationship between the technical intervention that I can make in an intensive care unit and what might be, then, for the good of that particular patient.  I can bring my expertise surrounding, if you will, the kinds of outcomes I can produce — again, if you will, structured within the probability of those kinds of outcomes and within the information that we may or may not have based on research.

The parent, or the child if they're old enough, may bring, in fact, an important perspective on what they believe is good for them.  And it's out of — that particular discussion becomes a sort of negotiated model in a setting where it's not readily apparent that the technical good, the skills that I can bring as a physician, in fact serve the good of the patient.

Now, I'm not saying I'm only talking technical talk with them.  I'm engaged in this discussion, but I'm engaged out of my own particular expertise.  I'm not limited in that discussion.  Hopefully, I can understand the good, and they can talk about it.  In fact, not talking about it and assuming that the technical good is always right for the patient leads to problems, which we'll get into.

So briefly, on two of the ethical principles that I think are important as I struggle, if you will, with decisions around limiting or withdrawing life-sustaining treatment in both the neonatal and pediatric intensive care unit.  The first is the classic teaching of the symmetry, if you will, between withholding and withdrawing.

This was stated by the President's Commission on Bioethics in the early 1980s, and the standard view is that, in fact, if a treatment is or is not medically indicated, that there is no moral or legal difference between withholding it or withdrawing it.  If you've decided not to give it, that's fine.  If you give it, you can take it away, depending upon whether it's medically indicated.

That those individuals, whether physicians or parents, who struggle with taking something away that has already been started, if it's not medically indicated, it is just a psychological issue.  It's not a moral or a legal difference.

Now, although I generally agree with that, I think there are exceptions, and so I do not think that this principle stands on ethical grounds as always being true.  Why is that?  It assumes that the technology itself is value neutral; that, in fact, when you've applied it there are no values that come with it.

It ignores the social and organizational context of that technology, the values that have, in fact, shaped it, and the impact of any change over time.  What's different then, in the future that might be different now?  And it reduces technology to an essential physiologic function.  In other words — and let me give you the examples.

The palliative surgical procedures — in other words, gastrostomy.  A gastrostomy is not the same as a nasogastric tube when it comes to issues of withdrawal.  To argue it is I think ignores important moral differences in the application of that technology. 

Neither is a tracheostomy.  Now, that itself would be a broader discussion, and I may be laying out something.  I'll get into that a little bit later as well.  But I personally don't think in certain circumstances that this symmetry holds.

Now, the doctrine of double effect — this may be familiar to some.  It's certainly not familiar to clinicians, even though we talk a lot about double effect when we use medications in the intensive care unit.  Let me just make a few points here.

The object of action must be right or indifferent in itself and cannot be intrinsically wrong.  I think that's fairly straightforward.  The wrong effect, though foreseen, cannot be intended.

Now, what happens here is often when clinicians, say, give a narcotic to relieve pain, if you look at studies there will be reports that a third to a half may have the intention to hasten death, although those same studies actually show — the ones done in the United States, putting aside The Netherlands for the moment, that the use of those medications in fact did not hasten death.

My suspicion is that those individuals are struggling with their ambivalence, and our thinking about intentionality in a psychological sense, not in the sense it was originally intended, which is the structure of the Act itself — in other words, you can interpret the intention of the actor by looking at the Act, not by what they say they think they're doing when they do it.

So if you're giving an appropriate dose of medication for that context, I don't care what you're thinking.  And if you're not giving an appropriate dose for that context, I don't care what you're thinking.  The act is how you interpret the intention.

Now, the wrong effect cannot be the means to the right effect, and this comes into the discussion of hastening death to relieve suffering, which I'll talk a little bit about towards the end of my remarks.  And then, finally, there must be a proportionate reason for allowing the wrong effect to occur, which gets to this balance of benefit and burden of treatment.

Personally, I think this is a very important principle behind the provision of either withholding or withdrawing life-sustaining treatment, or the provision of palliative care in the intensive care unit.  And one reason I believe that is I personally do not believe that I should ever intend, nor cause, the death of my patients.

And for me, then, to be able to provide care under that circumstance, given that belief, I need this doctrine.  And I know there's a number of criticisms that this doctrine has had in the literature, but I still find it both useful and defensible.

So I'm going to spend a fair amount of my time telling the stories of Baby Doe, Sidney Miller, and Emanuel Villa, to give you, I guess, a different take on what Norm gave you about the Baby Doe regulations.

Now, this states the regulations.  The regulations are now part of the Child Abuse Protection and Treatment Act, and they basically require medically-indicated treatment unless five — one of five conditions hold — the infant is chronically and irreversibly comatose, and I'll mention the definition of "infant" in a bit. 

Of course, setting aside there are no professional standards for determining chronic and irreversible coma in a neonate, treatment would merely prolong dying, treatment is not effective in ameliorating or correcting all of the infant's life-threatening conditions, treatment would otherwise be futile in terms of survival, and treatment would be virtually futile in terms of the survival of the infant, and the treatment itself under such circumstances would be inhumane.

Now, let me just at this point say I agree with Norm's assessment of the impact of the Baby Doe regulations in the 1980s.  I also agree with him that it was very important to stop behavior that I would consider unethical.

But any time you then try to write a general principle that covers the specific cases that gave rise to that general principle, and it gets divorced from those cases, it then, given the language, runs the risk of being applied in a way that was either not intended or extends it into arenas that were not foreseen. 

And that's, in fact, the story that we will then be discussing is:  where has it gone, and where might it go?  Not necessarily where has it been, and what was the importance of it at the time?

Now, one note is that the interpretation of these regulations, first, is that appropriate nutrition, hydration, and medication, without specifying what that medication was, must always be provided.  That was an exclusion in the regulations.  Nutrition and hydration, medically provided, is a controversial topic, and this takes a particular position on that topic for disabled newborns.

Another interpretation is the phrase, "It is clear that Congress did not intend to sanction considerations of the future quality of life of an infant likely to survive if the treatment is provided."  So the intent of the Baby Doe regulations, as stated, was to sanction any consideration of quality of life. 

And I think one challenge, if, in fact, we think that has gone too far, is to say, "Do we want to recapture that language?" which I think has difficulties with it, admittedly, or do we want to somehow figure out other ways to speak about the value of interventions for critically ill newborns and children.  That may avoid some of the problems surrounding quality of life language.

And then, just to show you that this may seem to be just a neonatal issue.  But, frankly, since the majority of children, if not the — if not at least a plurality of children in the pediatric intensive care unit, are graduates of neonatal intensive care units, it applies in that arena as well.  An infant was defined as less than one year of age.

However, if an infant is older than a year of age, and has either been hospitalized since birth, was born extremely prematurely, or has a long-term disability, these are also meant to apply by that definition.  So there is potentially an arena beyond simply neonatal decisions where this could be a player.

So I'd like to tell you a tale of two cases, with apologies to Dickens.  The first is Sidney Miller.  The date, 2003, was the Texas Supreme Court decision.  Sidney was born in 1990 at 23 weeks' gestation, either at 614 or 629 grams.  For those knowledgeable people, that's a bit heavier than you'd expect a 23-week infant to be. 

There was some discussion, at least as I could tell from the literature, since I don't know the case directly, of whether the child was — there was some in utero infection that may have resulted in some edema, etcetera.  But this was the case, and the claim was that she was resuscitated against parental wishes, which is fairly well documented.

The second case is Emanuel Villa, also known as Montalvo, from a Wisconsin case who was born in 1996 at 23-3/7 days — weeks' gestation at either 615 or 679, depending upon what document you look at, who was resuscitated with inadequate information.  And then, both parents claimed failure of the physicians to obtain informed consent for those resuscitations.

Now, here are the words of Mark Miller from an article in The Hastings Center report.  "We opted for compassionate care based on the neonatologist's recommendation that the alternative aggressive treatments would almost certainly cause painful lifelong illness and disability.

What happened, then, as that decision circulated out into the general neonatal intensive care unit, and other areas of the hospital, is that an administrator ordered a neonatologist into the delivery room without the consent of the parents to treat.  That basically was a claim that there was a hospital policy that all infants about 500 grams required resuscitation, and it was also based on an interpretation, if you will, of the Baby Doe regulations as applied in the State of Texas.

So those two factual claims are not in dispute.   It turns out, interestingly enough, it was a neonatal fellow who was the one that went in there, not the neonatologist.  Talk about issues of staffing and seniority, etcetera.

Now, the bottom line is the Texas Court of Appeals, and then the Texas Supreme Court, though both for slightly different reasons, said that there is no duty to obtain informed consent for resuscitation prior to the birth of a premature infant.  The Texas Court of Appeals based this on an argument that the child's medical condition was not terminal, which is language taken from the Texas Natural Death Act.

And the Texas Supreme Court based this on the fact that there's no requirement for informed consent, since the child born then at 23 weeks' gestation — under those emergent circumstances, the physician needed to make an independent decision about what was required.  And that was the argument of the Texas Supreme Court.

Now, George Annas wrote an article in New England Journal of Medicine with his assessment, and just let me point some of those comments out and then editorialize on them.  First of all, he commented that an informed decision about resuscitating an extremely premature infant can be made only by actually examining the infant at birth — is good medical practice.

Now, there's a debate about that.  There is some literature to suggest that if you have good early dates, which would exclude a number of mothers who present with premature birth, but if you had good early dates, and a first trimester ultrasound, that that's actually more accurate in predicting gestational age and then linking that with outcome, than an examination by a neonatologist at the time of birth.

So that's a debatable point.  But by and large, I think it is true that clinicians would maintain, if you will, the right to have discretion surrounding that resuscitation.

Now, he also makes a second point which I think is true, that it didn't require the physician necessarily to resuscitate.  It just requires the physician to evaluate, although we'll go a little bit further when we get to the Montalvo case.

The third point is he claimed that it would be unlikely that anybody would question a decision to cease aggressive care.  Sidney Miller suffered complications in the neonatal intensive care unit that many would argue was a basis for considering limitation or withdrawal of support.

The parents, in fact, did not make that decision.  They didn't feel morally they could.  It's a debatable point whether or not everyone would agree.  And then, finally, he makes the argument that parental consent is legally required in the NICU.  Well, that would be, of course, true unless the parent had no right to withhold treatments that were mandated for other reasons.

Now, let's go to Wisconsin and talk about — I'll refer to the case as Montalvo.  Born in 1996, 23-3/7 weeks' gestational age, 615 or 679 grams.  Again, resuscitated without — with inadequate information.  So this case — the parents agreed for resuscitation at the time, but then, as they learned subsequent to that the complications of prematurity, etcetera, they felt that that consent was not fully informed.

So the parents made the argument that they should have had the right to genuinely informed consent about the treatment of their extremely premature infant.  This quote is taken from a commentary that was published by the mother and father.  That's Nancy Montalvo, and I think it's Brian Villa, in the Journal of Perinatology in 1999.

And as a personal note, this commentary was a publication of a grand rounds that when I was still in Milwaukee I actually invited them to give, and it was a discussion between the father and then a mother of another infant who was born severely disabled who had I think a very different view of disability, and then a discussion by a neonatologist.  And that grand rounds became this commentary.

I don't know at that time if they had brought suit or not, but they subsequently did bring suit.  And the Wisconsin Court of Appeals made the following determination — informed consent comes into play only when there is a choice of available viable alternatives.  Apparently, that is an interpretation of Wisconsin state law.

And they gave two reasons after the cesarean, which was the mechanism of birth, why there were no available alternatives existed to give rise to the obligation to engage in the informed consent process.

So the first reason is absent being in a persistent vegetative state, in the State of Wisconsin there is no right to withhold life-sustaining medical treatment.  So requiring informed consent presumes that the right to decide not to resuscitate the newly-born child, or to withhold life-sustaining medical treatment, existed.

The Wisconsin Supreme Court, in a case in 1997 which involved an adult who was in a persistent vegetative state — and I believe on a ventilator was the issue of the life-sustaining medical treatment — found that withholding or withdrawing life-sustaining medical treatment is not in the best interest of any patient not in a persistent vegetative state. 

That's a double negative, but it's an important double negative because they did not say that it is in the best interest of any patient in a persistent vegetative state.  They specifically meant to exclude making that decision if you were not in a persistent vegetative state.  So the double negative there is important.

It basically means that absent — in the State of Wisconsin, absent the diagnosis of a persistent vegetative state, the Supreme Court of the state has ruled that there is, in fact, no right to withhold life-sustaining medical treatment from a child — for that matter, from an adult.  That that right does not exist.  And we're not talking about food and nutrition here.  Let's be clear.  We're talking about anything.  Anything.

Second reason — CAPTA prohibits withholding life-sustaining medical treatment.  Now, the argument that Norm made, which is an argument that has been made by many, including myself, up to now is that Baby Doe, at the local level as you're making individual decisions, didn't apply.  That it applied to state health departments.

Well, what's interesting about the Montalvo case is they basically said that because the State of Wisconsin fulfilled the requirements for getting state/federal funding under CAPTA, that, in fact, the federal language of Baby Doe applied to individual treatment decisions.

Now, whether or not that's a correct or incorrect legal interpretation, the point is that's what the court did.  And they pointed out that, in fact, this bars the withholding of medically indicated treatment, except for the indications that I showed you earlier. 

And so, therefore, the choice of withholding treatment — in this case, resuscitation of an extremely low birth weight infant at delivery — is exactly what CAPTA prohibits, in spite of the fact that there was nothing in there that was meant to apply to a 23-3/7 week's gestational age infant.

So the Wisconsin court applied it, even though there is no enabling legislation in the State of Wisconsin that takes the Baby Doe regulation language and applies it.

Now, to go one step further, there is even another case in Wisconsin — Burks v. St. Joseph's Hospital — where the Wisconsin Supreme Court allowed a Plaintiff's claim alleging a violation of EMTALA, which is the anti-dumping legislation.  If you come into an emergency room, you have the right to be treated.

Allowed a claim to go forward under facts where physicians did not resuscitate her 200-gram 22-week newborn.  Now, I don't know the results of this case.  I hope it settled out of court.  I'd hate to see what any court would say about this case.  I would fear that.

But the very fact that the court decided to allow the claim to go forward I think illustrates the risk there is of applying these federal regulations in this arena.

Here was a quote from the Wisconsin court, which I guess I would agree with, given what they're doing.  "If treating physicians can be sued for failing to resuscitate a baby they feel is not viable (Burks), and for resuscitating a viable baby (Montalvo), they are placed in a continuing 'damned' status. The public policy of Wisconsin does not tolerate such a 'lose-lose' enigma."

Now, lest we think this is just the State of Wisconsin, here is a quote from the Secretary of HHS, April of this year.  "DHHS will investigate all circumstances where individuals and entities are reported to be withholding medical care from an infant born alive, in potential violation of federal statutes for which we are responsible."  Two of which are the ones I've just shown you — CAPTA and EMTALA.

This Act, which has its intent I think to enforce, if you will, appropriate care for infants born right at the limits of viability, whether that's palliative care or otherwise, defines "born alive" as an infant at any stage of development who breathes or has a beating heart or movement of voluntary muscles, which would, in fact, include a 22-week gestation, 200-gram fetus, because they likely would emerge, if they emerge intact, from, say, a miscarriage with a beating heartbeat.

Now, maybe the courts just could help us with this best interest standard.  This is a quote of two courts.  One is the Wisconsin court; the other is the Texas court.  This notion of best interest, which is problematic and I think would require a fair amount of flushing out.  Others have written about its interpretation, particularly Loretta Kopelman, and pointed out difficulties in interpretation.

But here is what two courts said.  Wisconsin — there is a presumption that continued life is in the best interest of a patient.  Absent proof of persistent vegetative state, our courts have never — my emphasis — never decided it is in the best interest of a patient to withhold or withdraw life-sustaining medical care.  Again, any life-sustaining medical care, not — we're just talking any.

And then, in Texas, it is impossible for the courts to calculate the relative benefits of an impaired life versus no life at all, reminding us of some of the debates around the wrongful life discussions.

Now, in preparation for this talk, I sent around some e-mail requests to colleagues in different states who I knew who were involved in either neonatology or critical care, to say, "Well, what issues do you think are important to you?  What should I" — and this, by the way, was at the top of everyone's list, the issues surrounding, if you will, value of outcomes or quality in a palliative care setting and in intensive care.

But here's some quotes from the person who responded back to me from Wisconsin.  With the Montalvo case, and now an EMTALA case, there is concern among hospital risk management that these rules make it illegal to provide any form of palliative care to infants.  Any form of palliative care to infants.

We were once told by our district attorney that if we were to withhold or withdraw a trach vent from an infant with quadriplegia from an unknown C1-C8 brain stem lesion — essentially it liquified.  I'm not debating about the merits of this case, but I suspect it would be extended to others — that based on Edna MF, the case I showed you, we would be committing criminal homicide.

And for those physicians in the audience, you'll know that your malpractice covers civil litigation, not criminal.  You're on your own if that happens.

So let me give some personal reflections on technology, and this is where I'm going to be sort of leaving, if you will, the sort of legal and political realm and getting into a bit more personal reflections based on my experience in applying technology in the intensive care setting.

So back to this notion that technology is not value neutral — I think there is a bias or a moral blindspot that is created by this assumption that technology is value neutral.  First of all, it emphasizes the functional aspects of technology and obscures an understanding of social context.

The application of technology includes values and presuppositions that shape that technology and reinforce professional control.  For example, by doing a tracheostomy and going onto a ventilator, you become a patient in a long-term ventilator-tracheostomy program.

There are certain moral assumptions and values that take place within that program, that if you don't go into it knowledgeable about those values, you may find your choices highly limited, or the only choice being to actually leave that culture or environment if you feel that the values you have are emerging as different from that particular care environment.

Now, this is taken from the work of Barbara Koenig, where she pointed out that the technological imperative, if you will, to apply this technology is transformed into a moral imperative.  She is talking about plasmapheresis through a social process where technology becomes habitual or routine, even absent any evidence of therapeutic benefit.

Now, there currently has been studies about the therapeutic benefit of plasmapheresis in some limited conditions.  But long before we had any of those studies, plasmapheresis was felt to be morally and technically required for certain conditions, absent any data to support efficacy in that context.

So what about technology and end-of-life care?  The role of value — and I picked this language of value and burden and benefit to avoid the language of quality of life, which I think can be controversial and often open for misinterpretation.  So one issue is:  what are we choosing? 

This is influenced by one of my mentors in my graduate studies, Arthur Dyck, who wrote an article called "Bene Mortasia," where he basically said that what you're choosing is not death, but you're choosing of how to live while dying, even if, in fact, the process of dying is quicker under that circumstance.

In the intensive care unit, technology often turns dying from a recognizable transition to an indeterminate ordeal.  There are many patients who die in our intensive care unit where it's almost impossible to say where that transition took place, even if — from the moment of application of the technology to the moment of death can be three months, where that transition takes place. 

We can say when they're dead, and we can when they're not, but where they transition into dying as opposed to hopefully surviving on our technical care is a very difficult time, very difficult perception.

The whole argument of removing technology if not medically indicated — in other words, restricting it to that — it restricts removal to narrow technical criteria.  So, for example, a ventilator corrects respiratory distress and physiologic dysfunction, if, in fact — I mean, it's indicated if you need a ventilator, independent of the quality of life or what you want from that ventilator.

So if you ask me, "Is it medically indicated?" yes, it is always medically indicated if you have respiratory failure.  So if you're telling me I can only take it away for that reason, then you're restricting me and the family I'm working with to either removal under narrow technical criteria or you're asking me to sort of hide, if you will, my assessment of quality of life behind a sort of veil, if you will, of technical criteria, which Robert Veatch back in the discussion of spina bifida called a technical criteria fallacy. 

In other words, this was in response to the Lorber selection criteria, where quadriplegia — I'm sorry, paraplegia, a high thoraco-lumbar lesion was in that list.  And he said to hide your moral judgment about life in a wheelchair behind these technical criteria is a technical criteria fallacy.

That's potentially what we would be risking, if, in fact, we limit it to medical indications.  And so I would argue that avoiding any explicit discussion of the value of an anticipated outcome for a child's future life risks reinforcing professional power and authority in the application of that technology and disempowers parents.

So religion and technology — these are what I would call broad sociological generalizations, just based on my own experience.  Generally, the practice of religion in the United States is characterized by harnessing technology for religious purposes, supported by notions such as dominion.  We could have a long discussion about notions of dominion and the harnessing of nature, if you will, but Protestant ethics, spirit of capitalism, etcetera, but it — that's a starting point.

I hesitate to lay that out in front of this audience, knowing that that's sort of out there as a nice — it's got a big bull's-eye right in the center of it.  But we'll keep going.

Religious language has been incorporated into the technical practice of medicine.  For example, the Miracle Modern Medicine and Children's Miracle Network is, in fact, the name for the agency that does primarily a large amount of fund-raising for a group of Children's Hospital.  Very worthy fund-raising, but we are creating miracles.

Recently, I would argue there is a growing emphasis on right belief or orthodoxy, rather than faith or engaged response.  And the question I then ask is:  to what extent have the values and beliefs of technical interventions supplanted the values of religious faith?

There has been a shift in 30 years from instrumental to intrinsic good.  What happened?  Two quotes.  1957, Pope Pius XII was asked by a group of Italian anesthesiologists, "Can we remove someone from a ventilator?"  His answer was, "Life, health, all temporal activities are, in fact, subordinated to spiritual ends."

There was an article published in Issues in Law and Medicine in 1987 on the topic of withholding fluid and nutrition, and in that was this particular quote.  It was signed by a large number of theologians and ethicists.  "Human bodily life is a good of the person, not merely for the person.  Such life is inherently good, not merely instrumental to other goods.  Thus, remaining alive is never rightly regarded as a burden."

So somehow we've come from what I would argue is an instrumental view of the importance of, if you will, biological life, to an intrinsic view of its value. 

What happened?  Well, that article needs to be set into the context of the debate about the withholding of fluid and nutrition from Nancy Beth Cruzan.  That's what it was particularly written in.  You'll notice the dates there — it was 1987 when it was published.  I think the Supreme Court case was decided in 1986 or 1987, around that time, but that's basically the context for this debate.

So I'd argue that what is happening here — and I don't mean to get into issues of abortion, which is not really our topic — but what has happened, and I would also agree with some philosophers, whose justification for abortion would lead people to be rightly concerned that they could justify infanticide.

Is a view of a transition and a continuum, if you will, among all of these various issues — abortion, infanticide, and euthanasia.  I have just selected some dates — Roe v. Wade, 1973; Ronald Reagan, Baby Doe, 1982, when Baby Doe was born; Baby Jane Doe, which was another case that led to the Supreme Court affirming the right of parents to make a decision in the particular case of Baby Jane Doe in 1986; Cruzan in 1990 — there is the date of the Supreme Court decision — and then, in 1994, Republican control of the Congress.

Here is a quote taken from a blog around the time of the discussion of Terri Schiavo.  The point here is — that I want to make is that about Terri Schiavo, but about the link between all of these different cases.  So when we get to a discussion of the limitation or withdrawal of life-sustaining treatment in popular culture, all of the various issues of abortion, infanticide, and euthanasia, are seen in a continuum.

One challenge is:  how do we break that?  Because I see them as very different issues, very different issues indeed.  How do we break that?  And what kind of language can we, as a society, capture to break those links?

Now, let me make some final comments before my concluding remarks on Groningen Protocol, published in the New England Journal of Medicine.  Here are the three categories of infants that it was proposed that that would be applied to — those with no chance of survival despite optimal care. 

Here, although there are many infants that we might support, many children we might support for a long time, I think anyone would agree that if, in fact, that support becomes useless, that in consultation with the family we would withdraw support.  And they would die quickly.

The second group — depending on ICU care with a poor or a grim prognosis.  Again, if there's a decision that the burden and benefit of treatment, as mentioned before, you affirmed in adults, we, of course, would decide to limit or withdraw that support in usual practice.  Open question whether in Wisconsin you could do that as a legal question, but that's what we do, and they would die.

It's the third one that's I think particularly controversial — those with a hopeless prognosis who experience unbearable suffering.  And it's that group that the Groningen Protocol I think was presented as applying to, where, in fact, they sought what I would call a technical end to suffering — 22 cases where they published.

Now, personally, two comments here.  I think it's a problem.  I think it's seeking a technology to end something that is not a technical issue.  My conversations with parents, as much out of my own beliefs, if appropriate, is that all of the children in my ICU are suffering, even those that will recover, and that the issue is suffering to what purpose, that I have a technology that I can, in fact, treat pain.  I have a technology that I can, in fact, treat agitation.  I don't have a drug for suffering.

So there is, you know — so the ability there is it allows me, if things don't go well — in other words, if that purpose becomes suspect, over time it allows me to transition to a discussion of the purpose of that suffering without having a big sort of shift in frame of reference.  But that's my own sense.

And deciding to choose death or to hasten death to end suffering is not something that I would support.

So let me make some concluding remarks.  Somehow, we need to bring what I would call life to the end of life.  We need to acknowledge the values that drive our medical technology.  We need to appreciate the relationship between these goods of medicine — the technical good, the good of the patient, and the ultimate good.

We need to foster the good of the patient as the purpose and goal of medicine, not reduce it to just technology, because we fear that discussion, which is what's happening I think with the extension into eschewing any discussion of quality of life in end-of-life issues in pediatrics.

We need to help patients and families through their, and our, experience of suffering, and the purpose such suffering may serve.  We should respect the diverse religious and cultural values that inform the experience of illness, dying, and death.  I have made an argument, both locally and nationally, that we should respect, for example, religious objections to brain death determinations, death on neurological criteria.

The New Jersey law allows that.  We often get patients from New Jersey to Children's Hospital of Philadelphia, and we respect that parental determination.

We should seek relief or detachment from suffering through setting aside our attachment to medical technology.  And we should nourish the wisdom to use technology in a way that does not obscure our vision of the ultimate good, which I would argue I think is happening to the extent that I believe that technological values are actually corrupting, in some way, spiritual values.

And then, finally, to hold children and their parents hostage.  My intent here is to be proactive — to hold children and their parents hostage, condemned to a life of suffering for no apparent purpose, because we feel obligated to fight a rear guard action against the introduction of moral values above and beyond those of the mere perpetuation of biological life is immoral, rather than respecting life, such an unrestrained imposition of medical technology desecrates life.

Thank you.

CHAIRMAN PELLEGRINO:  Thank you very much, Dr. Nelson.

We can begin discussion of Dr. Nelson's paper.  Anyone want to begin?  Thank you.  Gil?

PROF. MEILAENDER:  Yes.  I don't know whether this is the most important place to begin or not, but it would help me if you could give a little more specificity on something you said very near the end.  You said that technological values are corrupting spiritual values.

What sort of spiritual values do you have in mind?

DR. NELSON:  The place I would start I guess is to go back to the balance between what I called an emphasis on right orthodoxy versus faith.  And this doesn't happen all the time, but my impression is that there is both a social and cultural emphasis, a religious emphasis, and in the minds of some parents, depending upon how they're advised by their religious advisors, an emphasis on what should we believe in this context, that somehow, you know, what is God doing, what is God not doing, what can we learn from this, etcetera, as opposed to, in my view, trying to appreciate the meaning of that experience from a perspective of faith.

Now, that — I'm being somewhat obscure, I realize, but I've occasionally tried to talk with families about, you know, if the relationship justifies sort of going in this direction.  It's not all the time.  I don't want you to think that I do this a lot.

But, for example, the differences between faith, hope, and love — I mean, I'm — as I talk with families, I'm — I encourage them to think more about how they should respond about the treatment of their child out of love, and try to show them how that parental love in some sense may guide them better than some notion of what they ought to do as dictated by, I would view, a sort of misplaced emphasis on orthodoxy, depending upon their religious perspectives.

So those — I mean, it's — I mean, I guess that's part of the discussion that would have to take place.  I don't — you know, I've talked about that with individual families, but that would be part of the discussion.

PROF. MEILAENDER:  Well, if I may just press it a bit, wouldn't you think there might be circumstances in which my sense of what I ought to believe should appropriately temper various feelings that I have, which I, at the moment, think may be loving? 

I mean, there is no imprimatur placed on my feelings at any given time, and it may be that they need guidance and discipline, and so forth.  It just seems to me that whole process is considerably more complex than setting sort of right belief against right feeling.  And so I'm still a little confused.  These seem to be both spiritual values, which generally exist in some sort of complicated interaction.

DR. NELSON:  Agreed.  And the last thing I would want to be — have happen is for you to misinterpret me to argue for a sort of Joseph Fletcher approach against a Paul Ramsey approach.  No, I'm not going there.  The problem is that this is just not a conversation that we — I mean, if we tried to carry this conversation, you know, outside of the bedside conversation, where it's a much more nuanced and complex discussion into a more broader social conversation, my fear is it would get polarized immediately into the kinds of issues that have made it very difficult to approach — cases such as Terri Schiavo, which was really not about her but about a lot of other issues.

So that's my fear.  I mean, at the bedside, yes.  You know, personally, I mean, I — you know, I can respect, and we do respect as a group, for example, a parent's objection for religious reasons to declaration of death on neurological criteria.  From other people's perspective that's the ultimate futility in the provision of treatment.  I'm treating a dead person.

But, you know, I'm not arguing here that there is one belief that needs to stand.  In some sense, it's that we need to appreciate the plurality of that belief and be able to foster that in a context where there seems to be a single sort of orthodoxy now that is coming through the court system.

PROF. MEILAENDER:  Just once more, and I will stop then.  But you did not — you said that you did not think that it was appropriate to deliberately intend to end someone's life simply in order to relieve their suffering.  And so I take it, then, that the fact that in some hard circumstance I am drawn to that, and I feel that that sort of would be the loving thing to do, doesn't trump for you the right belief that that would be the wrong thing to do.

It just seems to me that — in other words, I — there is probably some point at which belief shapes end gauged response, to use your language, and so the issue isn't really one about whether, you know, the right spiritual value is engaged faith versus orthodox belief.  The issue is under what circumstances is there a belief in shape — in place that's sufficiently strong that it should govern response.

DR. NELSON:  Let me complicate my position a little bit further.  My statement that I would not do that it isn't much shaped in my role as physician.  All right?  We could get into a much longer discussion about whether assisted suicide in other contexts is or is not appropriate.  So, personally, I think the last people that should be doing that are physicians, given all of the discussion you had about the importance of talk and the lack of talk.

But, so some of that is shaped by my view of professional role, and that would have to sort of nuance that conversation.

PROF. DRESSER:  Skip, I think you made a point that I don't know if anybody would disagree with, which is that when you try to write rules on these complicated issues, they are likely to be misapplied.  And, you know, we just went through some of these — the process of trying to think about when it's appropriate to withhold or withdraw in people with dementia.

And we ended up talking about a standard that we called best care for the patient now here.  And in terms of describing that, there were some statements of "here's what this would mean in the abstract."  But we went through some cases, and we talked about how one person might think that this is the best care for the patient now here.  Another person might think this is, but these are all sort of analyzed and presented in a sort of a case-based reasoning approach.

I wonder if you think there is a better way to do it, or do you think that there is a way to write rules that would work in a satisfactory way?  If not, it seems we do have to rely on discretion at the bedside. 

And is that better, do you think, than trying to write a rule?  I'm just wondering, how would you apply your thinking in this presentation to figuring out a way of approaching these cases as a policy matter or as sort of putting forth some ethical principles?  I'm just not quite clear on that.

DR. NELSON:  This is one of the difficulties is sort of where we are now as opposed to where we've been.  I think it's important to protect discretion at the bedside.  Do I think it's important enough that I would then sanction unethical decisions?  No.  And so the challenge is how you tease those apart.

The story I've told you, which is playing out in Wisconsin, which is not playing out in other states, but I think that's not because it couldn't, is where those rules are basically intruding into an area of discretion, where I don't think they need to intrude, nor were they intended initially perhaps, nor should they.

I agree with Norm that a lot of the activities that have taken place in hospitals around ethics committees I think sort of, by and large, brought a lot of those decisions out into the sunshine, if you will, at least locally, not broader.  So it's unclear to me at this point that we need more rules as opposed to sort of a rollback.

And the only way I could understand or begin to say, "How could we have that happen?" would be to foster a conversation, which I could see this group is trying to do, around the very issues that we were just talking about.  At this point, you cannot meaningfully — you can talk with a parent about this.

I mean, you can conceive of how you could talk meaningfully about the value of continuing the treatment we're doing, the burden of that treatment, the benefit that we might achieve, the outcomes that we may expect, the chances of those outcomes, etcetera.  That we can do at the bedside. 

I don't see us having that meaningful conversation in a broader society, which I mean includes the society that parents run in.  It happens in professional journals, but it's not happening in a way that seems to be impacting on the interpretation, if you will, of laws that exist at state and federal levels, etcetera, and the like.

I mean, I can't imagine that the Montalvos think the result of that case is a good one.  I would hope not.  It's exactly the opposite of what they had hoped.

I don't know if that's responsive, but I guess it's more about conversation and less about regulation — how to capture that kind of language, so we're not, then, back into a debate about abortion and infanticide, but about how we can meaningfully talk about reasonable decisions about the application of our technology.

CHAIRMAN PELLEGRINO:  Dr. Lawler?

PROF. LAWLER:  The questions remains, though, how much rollback, assuming we need rollback.  For example, in your slide on page 10, I like Pope Pius XII, and I am guided by him in many ways.  Nonetheless, he can't guide American law, actually.  And under American law, spiritual values really don't trump the right to life.  The right to life stands as its own bottom, so to speak.

So the abuse that brought these Baby Doe regulations into being was parents choosing to think that someone who has Down's Syndrome has an unacceptably low quality of life.  I think you and I agree that that decision is not only unethical, it probably should be illegal.  Not unethical in some abstract sense, but it should be against American law.

Now, if that decision is — should be against American law, then how much discretion can be allowed to compromise life?  I mean, I — you know, surely some discretion I guess.  But it's not — I don't think it's enough to say all of this can be decided by conversation, because conversation has to be bounded by law, and law has to be based on respect for the right to life.

So how much discretion would you allow, given, in your opinion, we need more?

DR. NELSON:  Well, I certainly wouldn't end with conversation, and ultimately there would have to be some way of carrying that into legislation.

The Baby Jane Doe case in 1986, which the U.S. Supreme Court actually affirmed the right of a parent to make a decision to withhold in this case surgery.  It turns out I think she survived; I don't recall how long — but as sort of part of parental rights.

Now, you know, that's sort of a parallel history to some extent from the regulations.  One of the difficulties is Congress is not supposed to practice medicine.  I mean, if you look at the — if you look at the proposed rule, there were a lot of cases in it.  The final rule, there were no cases.

And so you end up with these principles that are divorced, where you and I might agree that it would be appropriate for a parent not to decide to treat a newborn who would meet the disabled newborn criteria by the Baby Doe regulations.  But by the regulations themselves, in applying them, that's not a readily apparent interpretation.  And that's the challenge.

Right now, they are divorced of cases.  They stand in a way that explicitly eschews any discussion of quality, which, in my view, is precisely what we as physicians are about, not just biological life.  All right?  But then, how do we get that in a way that is not discriminatory I think is important.

And that's a conversation — you can say, no, I don't want to end with conversation, but that's — right now, it's polarizing.  Right now, as soon as you bring up that topic, it's polarizing, as opposed to trying to discuss the values that allow us to say, well, you know, that's really not what we had in mind.

I don't — you know, if I had a solution to that, I guess I would have very quickly written it up and sent it somewhere to publish.  I don't have a solution for that.  It just strikes me as a problem that — that exists there at this point in a very polarized society around these issues.

CHAIRMAN PELLEGRINO:  Leon?

DR. KASS:  Let me try, on the same — on this same subject — I think I share your sense that a certain kind of rigidity leads to decisions that everybody present would recognize as somehow wrong, at least that's their common sense, and that one is imposing — one is behaving in a kind of cruel or inhumane way, simply to uphold a certain kind of principle. 

I mean, I — let's at least stipulate, and I think that could be part of your resistance to the rigid adherence to a certain kind of never or always.  And let's also agree that it's not just scare tactics, but — and it's not just the polarization of a society that would lead one to be concerned about how it is we actually justify the withholding and withdrawing, because, I mean, Norman before talked about it's in the best interest — sometimes it's in the best interest of the child not to be here.

That's a funny thing to say without politics.  I mean, it's a strange thing to say, especially on behalf of a child, but never mind.  So you were groping for a way to articulate so that other people could understand your reasoning or your justification, when it is that it makes sense not to use life-sustaining treatment.

I'm not sure I understood exactly how operationally — how you would make operational this very nice intuition about the difference between choosing death versus choosing how to live while dying — a distinction to which I am quite friendly.  But as you so point out, in the presence of devilish interventions, the transition to being in the process irretrievably of dying is opaque.

You want to get away from talking about quality of life language, and yet it seems to me you are stuck.  Unless I've missed something — and we've struggled with this at the adult end, and, as Rebecca said, with patients with dementia.  We all have a certain sense this is — this is cruel — these interventions are cruel and nonsensical.

And if you say, "Why?" can you give an answer that says otherwise, says something other than that?  This patient's life is not worth living any longer.

It didn't come out all that well, Dr. Nelson, but I'm — I'm looking for a way in which we could not simply go on our gut instinct in these matters, but to try to articulate in communicable form so that other people could say, "Yes, I see that, even if I don't agree with you."

DR. NELSON:  I think one of the reasons why I wanted to initially sort of avoid quality of life language is I didn't want to have what I was saying sort of immediately fall into the sort of polarizing positions around quality of life.

DR. KASS:  Right.

DR. NELSON:  But that language is, in fact, the language that you might use at the bedside, maybe not those words but things such as the child would no longer be — certainly, in the pediatric ICU will not be the child you knew.

DR. KASS:  I'm sorry?

DR. NELSON:  You know, the child — the child will not be — it will no longer be the child you knew.  I mean, those kinds of language about transition, often in terms of neurological damage, even if one is anticipating possible survival, and the like.

You know, if you look at limiting or withdrawing support in the intensive care unit specifically, and to some extent in the neonatal ICU, the bulk of it is around resuscitation.  Literature suggested anywhere from 40 percent to 70 percent or higher of children who die in an intensive care unit die in association with some limiting or withdrawal of support.

The bulk of that is simply deciding not to resuscitate, so they die.  Then, you've got not escalating.  You've pushed the envelope as far as you can push it.  It can't be pushed any more.

Then, you've got the taking away of pressers and extubation.  That's actually less likely.  So the kinds of decisions we're doing we think of — and fluid and nutrition I could think in my — you know, over the last 15 years count on one hand the number I'm familiar with.  And I've actually never recommended that to a family.

So we talk about those cases, but the bulk of it is just deciding not to apply fairly simple resuscitation technology.  Quality is part of the language, and the value of that life going forward, the burden of the treatment to get there, that's what we do.  I'm perfectly happy with discussions of excessive burden for achieved benefit, but I don't read any of the things that I showed you as allowing that language unless we protect that discretion.

And so the issue is how to do — how to protect without losing of ground.  I agree that's a challenge, but that's I think what has to be done, somehow protect that discretionary space.

One final anecdote — the interpretation of what's going on in Wisconsin certainly is often the advice of general counsel in other institutions and other hospitals where they will say, "Well, if you do that, even if it's agreed to by the physicians and the parents as reasonable, if you do that, you will be in violation of these regulations, and you could go to jail."

Even if, in fact — I know Norm points this out when he talks on this topic — there is no such case of anyone, if you will, going to jail for violating what would be perceived as a strict application of the Baby Doe regulations.  There is no case, but legal counsel in hospitals often gives that advice.

DR. KASS:  May I just follow up?  Leaving the law aside and just sticking on the plane of ethics for a moment, are there — you talked about resuscitation, and there you could I think easily speak about the possible burden of the treatment itself.

Are there cases where you would make a decision not to resuscitate, which would lead you also not to give antibiotics in the presence of an infection?  And if not, why not?  In other words, if you've made the determination that this is a life in its trajectory to the end, how would you set about distinguishing those two cases?

DR. NELSON:  I guess I would not start where you started.  The conversation I would have with a parent would be that what we're interested here is in the — if you will, the quality of the experience of that child for whatever period of time that child is with us. 

And if the provision of oxygen helps, even if it — if it helps the experience, even if it might delay death, or the provision of antibiotics, depending upon what that may be for provision of fluid — in other words, if the focus is comfort at that point, my general approach — and by and large, I think most ICU docs — is to have sort of a — it's an a la carte menu.  It's not — you know, it's not, oh, you're going to get it all or you're going to get nothing.  It's taken on a case-by-case basis.

And there would be instances where you would — may not given antibiotics, and there would be instances where you would based on that difficult judgment.  But I think that would separate — we have also had families who might for resuscitation perceive, for example, intubation as being invasive.  But they wouldn't feel that way about chest compressions, because, you know, they've seen it on TV, and it doesn't look so bad, etcetera.

We know, as professionals, that that can be a very invasive thing to do to somebody.  And by and large, my experience has been if you have a parent available at the bedside, as they often are, in the hospital, particularly in the pediatric intensive care unit, and they see that, they will tell you stop immediately because they didn't realize that, in fact, it is as invasive as you've said it was.

So the reality is what they see.  So all of those kinds of decisions I think are taken case by case and not sort of you get it all or you get it none.

DR. ROWLEY:  Well, I hesitate to enter into this discussion, because much of it is in the area of ethics, where I don't feel terribly confident.  But we have discussed over time here at the Council the issue of medicalization, and it's always in the context of some living individual and that — like ADHD or all of the things that may be behavioral in children, which may be better left just to either letting the child grow out of it or other kinds of professional discussions with the child rather than drugs.

But it seems to me that in the neonatal intensive care unit, particularly as technology gets better, we're going to be able to keep more and more premies of lower and lower birth weights alive through medical technology, and then you have to ask, what really is the cost to the child involved, the infant involved?  What's the cost to the parent?  What's the cost to society? 

And we were pushing — or I was pushing Norman to say, in terms of issues, that we really should talk about what are — are fundamental, broad, ethical issues regarding children — the cost of neonatal intensive care unit is enormous.  And you think of what that could do for immunizations for children, for food for children, for professional help for babies in premature — in poor families, just to begin to get the minimum of care.

You know, I worry that what you're saying is that technologically we can do things.  Then, if you follow the Wisconsin law, you are forced to use these costly technologies for children, and I think there are data coming out of the likely quality of life that a preemie of certain birth weights have in the future for mental retardation, for cerebral palsy, for long-term requirements of very strenuous care.

So I can't formulate this very well, but it — I'm on your side in terms of saying that the physician has to have some ability to use his judgment and help educate parents to what the future outcome of a child of — infant of 200 grams or 300 grams, even 5- or 600 grams, what is their long-term expectancy for really high-quality life?

DR. NELSON:  A couple of comments.  First, I think if we want to look at the cost of intensive care, I think it's very important to do that in an intergenerational way.  What do I mean by that?  Sure.  Neonatal intensive care is expensive.

But if you do it on the quality of adjusted life years, and you look at what you get — you know, the bang you get for your buck, you're talking about someone who survives.  We'll get to whether they survive well, but someone who survives productively for a large number of years compared to, say, adult intensive care.

So I — I don't want us to think — I would hope we don't think of the resources we put into pediatrics as a zero-sum gain within pediatrics, because children are not getting what they need now.  And if that's the case, we're not — we're basically robbing Peter to pay Paul.  I mean, it just — that would be unfortunate.

And neonatal intensive care is highly effective, and it's highly effective, even if expensive, for a lot of infants.  And so I would just ask you, then, to look more broadly intergenerationally about that distribution.

In terms of prematurity, I mean, the window that we've got now is that — neonatologists, if you look at surveys at least, and then you look at the biology, generally are uniformly in agreement that less than 23 weeks' gestational age, assuming accurate dates, etcetera, you just don't have a lung.  I mean, until we develop artificial womb technology, that is not a fetus-born infant who will survive.  It just won't happen.

After 24 weeks, the impact of surfactant, it used to be true that if you took, you know, 24 weeks, and then you took up at about 28 weeks, you could draw sort of a straight line, and mortality would just climb up that line.

Well, now, with surfactant, it basically goes skyrocketing in the first week, and then levels off.  And so, basically, the survival of 24-, 25-, 26-week prematures at this point in time is phenomenal.

Now, can you predict which one of those will develop cerebral palsy, which one of those will get a bleed, which one — you know, the complicated — necrotizing enterocolitis, short gut, I mean, all of those things are not something you can figure out in the first 24 hours.  I mean, if it's in the first — as I say to families, if it happens fast in an intensive care unit, it's bad. 

All things that happen good in an intensive care unit happen slowly.  So if in the first 24 hours some — I mean, something happens, yes, it's really bad.  But, unfortunately, a lot of bad things happen late.  So predictability becomes a problem. 

The issue of quality of life is complex, and from whose perspective, how do you measure it.  It's a very difficult life for families.  It's a very difficult life for the parents.  It's a very difficult life for the children.  But you ask them, and it's not that bad.  In fact, it's often pretty good, depending on who you ask.  So it's a complex question in terms of quality of life.

So I guess it's — there was something else, but I've forgotten.  If it comes to me, I'll say it.

CHAIRMAN PELLEGRINO:  Dr. Hurlbut?

PROF. HURLBUT:  This is a vague, very broad question, but you kind of introduced it.  Just from your experience thinking about these matters, if you project out 50, 100 years from now, you can imagine technologies such as what you just mentioned, an artificial womb or various interventions, maybe very early on in the womb.

Does there come a point where medicine is sort of out of its realm?  I mean, you — is there someplace where medicine is sort of an invitation but not an obligation?  You know what I'm asking basically, right?

DR. NELSON:  Well, I think — let me just see if I do.  I mean, there certainly is a point at which we ought to be circumspect in our use and development of technology.  But I think back to Norm's response on ADHD and drugs, you know, medicine is fundamentally pragmatic. 

If there's a problem that people address as a problem, and you can discover something that fixes that problem that happens to fall sociologically within the armamentarium of physicians, it becomes a medical problem.

It could be done otherwise, I mean, if we so choose.  We could take some of the things that physicians control as technology and let other people control them if we wanted to.  That would be one of my solutions to the issue — to the issue of assisted suicide.  I don't think physicians should control that technology.  Whether anybody should do it is a separate question.

Now, you know, we have, for example, a fetal surgical program.  Their patients — the mothers who come in with fetuses looking for treatment.  Occasionally, they'll elect termination, but by and large they have decided that they're looking for treatment for their child.

And, you know, so it's extending down into that area.  I can't imagine some of those technologies, but I suspect at this point, you know, unless — you know, it's really up to us to decide if it's a problem worth fixing.  And once we do that and identify it and get a technology that can, in fact, help, whether that's in medicine or not, I mean, it's going to happen. 

Medicine is fundamentally pragmatic.  I don't think you're going to see physicians doing that.  I think it's — you know, as a society, we certainly haven't shown any ability to control our health care — sort of provision of health care in any meaningful way, whether it's conceptually in the provision of resources or whether it's economically.  It's chaotic.  I guess it — so I hear what you're asking.  I'm not sure what the solution might be.

CHAIRMAN PELLEGRINO:  Dr. McHugh?

DR. McHUGH:  I found your comments very interesting, but they often turned, again, on this issue of quality of life, the ultimate issues of quality of life and how we doctors know about it.

I wanted to perhaps get you to — draw you out a little bit more on the stakeholders that relate to quality of life, and ultimately the individual who has the greatest stake in it is the person who is going to live or die.  And I was enriched by what you said about the value of neonatal care services and how they do produce people who are happy and content.

Perhaps put it this way.  One of the real problems with us doctors is whether the technology begins to shape our character to the point where our character is no longer open to other people's experience. 

Now, my encounter with that, my personal encounter with that, was the Hopkins program in sex change operations in infants, when it was believed — for no good reason and without any data — that the quality of life of a little boy born with calycle problems would be best served if his gonads were removed from him and he was raised as a little girl, and that human beings had such plasticity you could grow them up in either sex and it wouldn't matter.

And it was only when we insisted that there was contact from pediatricians to the young adolescent and adult girl/boy that we discovered that, in point of fact, those people felt themselves quite mistreated, and that they had been for the best of reasons, with the quality of life issues in — in front of them, that they had been fundamentally deprived of the opportunity themselves to decide what they were and would be, and that the doctors, instead of simply protecting them and making sure that they didn't have kidney infections through this, had decided what kind of life they would lead, and often on the basis of rather silly ideas about how an infant and child — a young child might feel about his genital structure during the time of development.

Now, are we — that's a long story, of course.  But it brings me back to this question.  Are we in the formation of our character, in the development of our care services, really consulting with the people whom we did serve to find out whether they think the quality of life they have, that might be different from the one that we have, is one that makes them happy?  That's a long enough question.

DR. NELSON:  Well, I agree with your story, if you will, about gender reassignment.  And one way one could understand that story is it really was an n of 1 that got it all started.  And as we began to appreciate the way that, if you will, bias prejudged the question of what the outcomes might be, and understood over time the impact of that, I mean, those biases are changing, but there is still a lot of debate around that issue.

We do have certain I think biases about what works and doesn't work, in terms of functionality, which you could also see as a predilection towards technology.  And by failing to sort of do the kind of work in sorting out the impact of that in terms of outcomes, the kind of research that is necessary, that is sophisticated.

When I think of neonatal intensive care unit, I was having a conversation the other day with a neonatologist from Israel who was at a meeting this past week in Washington.  It's called Hot Topics.  It's the neonatal meeting that occurs every year.

And what he said — there was an exchange between a couple of parents in the audience and a researcher who is presenting quality of life data.  And by and large, the quality of life data were things like, you know, how many kids that are born premature go to college, high school, I mean, those kinds of functionality things.

The comment of the parents was that there was a great disconnect between that information and their own experience.  Now, granted, that is anecdotal to parents in the audience.  I mean, it — obviously, highly selected to be motivated to go to a meeting of professional neonatologists, but that there was a disconnect.

But the important thing that I would take away from that is it's not that research is unimportant, but the methods perhaps need to be more sophisticated, and that the conversation needs to include parents, of course, and ideally include children.

Another illustration I was asked — I did a project looking at what parents would think about a waiver of emergency consent for resuscitation research.  I was asked the question as I was presenting that research, which I realized I didn't even consider.  Someone asked me if we had — step back.  That regulation requires community consultation, so we had consulted with parents as the community that would be involved.

Someone asked me, "Well, why didn't you ask kids?"  For some reason, it — for some reason, even as a pediatrician who asks kids many other questions, it didn't occur to me to do a focus group of, say, adolescents or eight-year olds around what they would want if their heart stopped. 

I don't know what the IRB would have done if I was going to do that kind of thing, but I asked them other kinds of questions.  Maybe I could have asked that.

So, yes, who you go to — I mean, I think it's very important that the perspective of parents and children be honored.  In many ways, my concern is that the — that we've driven, if you will, such an overlay of the regulations that I've gone through, and of the sort of debate to where at the bedside is a great risk of being unable to honor the expressed wishes of parents, particularly since children often don't have a voice, given how ill they are, in the intensive care unit, because of fears of the regulatory and legal environment.

That the desire of physicians is to, in fact, honor that, appropriately so, not inappropriately so.  And it's getting harder and harder to do that, and I think there's plenty of data that would support that shift.  And I agree with Norm that it's a shift from undertreatment to overtreatment, and somehow we need to get back — you know, sort of recapture the ability to have that conversation.

DR. ROWLEY:  Well, I would like to just follow up on this, and then tie it into my earlier question, because it seems to me with regard to the view of parents who had children who were premature, and particularly those that were very early premature, there must be more than anecdotal data on what kinds of stress, if any, those parents had.

Now, I was shocked by Norm's statement that in child abuse one-third of the children who are abused are premature.  And so I think that it would be useful in this discussion to have some sense of what the outcome is for those children, and I did bring up parents and families and what the impact of prematurity and level of prematurity is within the family.

DR. NELSON:  Yes.  There is data that exists, but I think part of — I guess two comments.  I think tackling the problem Norm identified, which is an important problem in my mind, is tackling the issue of preventing prematurity.  It's not tackling the issue of:  should neonatologists have withdrawn or limited support in a group of premature infants?  Because I suspect, even if we did that, the statistics would not change that he cited.

I'm reminded of a case that hit the press in Philadelphia where a caregiver basically beat a child with spina bifida because the child was not toilet-trained.  You know, so the frustration — a) that shows a fair degree of ignorance, but the point I'm making is the frustration that parents who don't have the kinds of home visitation programs that Norm mentioned, or the kinds of support that we ought to provide, when you're dealing with a child as they grow up who may have some limitations, whether visual or physical, because of the — just because of the circumstances of being born prematurely, even if those disabilities are not to the extent to which they are unable to sort of live quality, productive lives from their own perspective, that that kind of frustration I would suspect is a large part of the etiology behind the kinds of abuse that Norm mentions.

So that I would not tackle that problem by tackling the application of our technology.  I would tackle it by tackling the prevention of prematurity and the support that we give parents that are — have babies born prematurely.

DR. ROWLEY:  Well, but suppose the data say that the children — infants born weighing less than 600 grams have a 99 percent chance, or a 95 percent chance of severe cerebral palsy, severe mental retardation, and will lead handicapped lives for their — for as long as they live, and really severely handicapped lives.

Then, I wonder if neonatologists don't begin to wonder whether just because they can do something, and keep the infant alive, is this something that they should do?

DR. NELSON:  I agree.  But, unfortunately, the data is not quite so convincing.  If we had 99 percent, I think there would be no disagreement, but the data — even with the sort of worst conditions, say, a grade four intraventricular hemorrhage, is more in the 70 and 80 percent, and so you get into a very difficult discussion about the statistics versus this infant.  And it's a much more difficult decision.

Unfortunately, the data is not — doesn't drive the answer as clearly as that would.  I don't think anybody would disagree.

CHAIRMAN PELLEGRINO:  Unless there is an urgent question, I think we have reached the point where we need to break for lunch. 

Thank you, Dr. Nelson, for a stimulating discussion covering some very, very difficult issues.  I've been restraining myself.  I have lots of questions along those lines. 

I want to thank the audience and — particularly the Council members, and I think we'll return here at 2:00 to pick up other facets of this same range of questions in a little different direction.

Thank you very much.

(Applause.)

(Whereupon, at 12:34 p.m., the proceedings in the foregoing matter recessed for lunch.)