THURSDAY, December 8, 2005
Session 2: Ethical Issues in Neonatal and Pediatric Intensive
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
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.
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
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
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
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'
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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,
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
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
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
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
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
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
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
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.
(Whereupon, at 12:34 p.m., the proceedings
in the foregoing matter recessed for lunch.)