THURSDAY, December 8, 2005
Session 3: Taking Care: Ethical Caregiving for Children, Too
Loretta Kopelman, Ph.D., Chair, Department of Medical Humanities,
The Brody School of Medicine at East Carolina University
DR. KOPELMAN: It is certainly a pleasure to be here, and
it is an honor to be asked. It's particularly an honor to be
asked by Dr. Pellegrino, whom I consider the father of medical ethics
in this country.
I was asked to discuss issues of assent, consent, and permission
for therapy and to some extent for research as well. And that is
a huge topic. So I was trying to think of a way to limit the topic
And what I thought I would do is use your own recommendations
from Taking Care: Ethical Caregiving in our Aging
Society and apply it to minors; in particular, your strong
recommendation for individualized decision-making using the best
care and best interest standard. I think that would be a wonderful
standard to use for all minors in many of the same ways you recommended
using it for individuals lacking decision-making capacity.
So my goals today I'll put under two headings: to discuss
issues of consent, permission, and assent in making minors'
health care decisions; and in choosing policies that support individualized
choices using the best care or best interest standard, which is
what you recommend in Taking Care.
The first topic is issues of consent, permission, and assent in
making minors' health care decisions. Let me just say a little
bit about language and the use of language here. Increasingly,
the pediatric literature is talking about parents and guardians
giving permission and reserving informed consent for something the
person does on his or her own behalf. So you give informed consent
for yourself, permission to have therapy or research involving your
child. And not everybody uses that language, but it's getting
more and more common in the pediatric literature.
And assent means affirmative agreement for those who lack decision-making
capacity. It does not mean they passively go along. It does not
mean that they haven't objected. It means a positive agreement.
And that's how the word is generally used as well.
Now, in the case of health care decisions and decisions involving
research for children, the ideal is shared decision-making and consensus.
Where clinicians and parents and the children all agree about what
should be done, that is certainly where there is a discussion and
That is the ideal. Next best is where there is a discussion and
maybe it isn't everybody's first choice, but everybody can
go along with it. In many cases, that's okay, too. There's
a consensus about the plan.
Parents or guardians generally have wide authority to make decisions
based on being most committed to their child's best interest;
most knowledgeable about them; involved for the long term, not the
short term, not for one particular hospital stay but for all their
care; and also because parents are most influential in fostering
values and traditions that make us who we are, the kind of people
we are. And because we generally think that's important that
we have certain values and traditions that are a part of who we
are and the decisions we make, we give parents or guardians certain
latitude in the kind of decisions that they make.
Just to review the elements of informed consent or permission,
disclosure of all material information, and in a therapy setting
that would generally include diagnosis, prognosis, treatment options,
and consequences, likely hazards for benefits.
In addition, there's understanding of the information disclosed.
As the risk of the procedure or the research or the therapy increases,
the more the clinicians has a duty to check and make sure that people
actually understand that information, perhaps by asking them questions
or asking them to use the information. This can be, this checking
can be, important, particularly if it's a long-term therapy
or research project.
People ought to know they participate voluntarily, they're
not coerced, and that physicians have a duty to make sure the person
giving permission or consent is competent to agree or deny participation,
and that they actually agree or authorize the intervention, in fact,
procedure, or research.
In research, there are additional elements of informed consent
or permission. One is disclosure that it is research. As Rebecca
has written, there is sometimes a misconception that therapeutic
research is seen as therapy when, in fact, it is not of benefit
to the particular child who is involved. And it would be important
for people to address that therapeutic misconception on the part
of those giving consent.
You're obligated to talk about the hazards or potential hazards
or benefits of the study in and of itself, as opposed to what may
be involved in therapeutic research. They need to know that the
research is voluntary and that the alternatives to it are explained.
They need to know how confidentiality will be maintained, what
compensation is available should they be injured, and who to contact
to answer questions. And the institutional review board has the
duty to make sure that these are fulfilled in a reasonable way.
They may also add other issues, such as the cost of the study, if
there are issues relating to pregnancy, dangers, or what will happen
in the event of new findings.
As the risks increase, so should the safeguards for research involving
children and others. And in "no benefit" studies, studies
not designed to benefit the children, as the risk increases, there
is more and more duty to check that the study is appropriate and
within the rules.
Parents generally give consent or permission, both for research
and therapy. For studies not funded by the FDA, teams can sometimes
give consent for themselves for minimal risk studies without their
parents' knowledge or permission.
In therapy and in some therapeutic research protocols, parental
consent can be waived if, say, in an emergency situation. Parental
and guardian authority can be challenged if they neglect, abuse,
or otherwise endanger the child.
In the beginning of the Twentieth Century, children were generally
viewed as property. Children are no longer viewed as property,
as they were in the beginning of the Twentieth Century.
Parents and guardians could give permission for therapy or not
for their children, as they did for themselves. If they made a
bad decision, well, that was very unfortunate, but the parents owned
the child. So it was their choice to make. You could try to talk
them out of it, of course, but it was their decision.
In the course of the Twentieth Century, children obtained rights
to have a certain threshold of care, independent of what their parents
wanted. And guardians were seen to have duties to children if they
abused, neglected, or otherwise endangered their child.
The most frequently used standard for persons lacking decision-making
capacity, including children, is the best care or the best interest
standard. I note I have included your definition of best interest.
You have defined it as a legal standard. I would only say it's
also a moral standard of caregiving for incompetent persons.
You defined it in terms of what a reasonable person would consider
in the same situation. A consideration of the best interest generally
attempts to weigh the burdens and benefits of treatment to the patient
in his present condition when no clear preferences of the patient
can be determined.
I would only add to this. It presupposes some kind of consensus
about what choices are unacceptable. I think if it's defined
that way, we can leave some flexibility in the best interest standard,
rather than think of best as there's one and only, one best
thing to do, an ideal approach to take.
So it presupposes, I would say, a consensus about what is acceptable
and what is not acceptable. And I think it is very hard to use
without such a consensus.
Also, it's usually said in this way as a consequentialist
standard, but I would argue that it presupposes a framework of rights
and duties as well, in which to use the best interest standard.
Sometimes it's not clear what is the best care or the best
interest. And I have incorporated in my talk three different cases,
which are not high-profile cases, like those that were discussed
this morning. These are all cases that house officers picked.
We have a monthly conference. We meet with the house officers.
And each one at some time over the course of their three years as
a pediatric house officer selects a case that he or she regards
as particularly challenging that the house officer was involved
This is one of those cases. This is a house officer. She had
been a house officer exactly three months when she encountered this
J. R. was a 14-year-old boy with a rapidly progressing lymphoma
and uncertain prognosis. The parents are from another culture,
where competent adults are rarely told such a diagnosis, and insist
they do not want the child told anything about the diagnosis or
prognosis. They want other explanations given for the therapy he
When his parents are not in the room, J. R. asks, "What's
wrong with me?" So what should this brand new house officer
in pediatrics do? Any information you would like about this case
before I move on?
DR. McHUGH: Well, I would like to know whether
she knows anything about this boy other than his medical diagnosis
and whether she has had conversations with him about his life and
DR. KOPELMAN: Yes. This is her case. She has known him
since his hospitalization. She knows him well. She knows the lab
findings. She has met his parents. She identifies this patient
as her patient.
DR. McHUGH: I will go on a little bit more. When
she was told these things by the parents that this is what they
want, what did she say to them at that time?
DR. KOPELMAN: She didn't say much of anything.
DR. McHUGH: I see.
DR. KOPELMAN: Now, there's also an attending, who
is not around right now. This is in the early evening. I'd
say about, she said about, nine o'clock. And nobody is around,
just her, the nurses, and this 14-year-old.
I should say that there are some studies that suggest 14-year-olds,
particularly who have life experiences like this, are pretty good
decision-makers, almost as good as most adults. They have capacities.
And some studies find they have capacities similar to adults in
dealing with issues like this.
DR. ROWLEY: I guess I would temporize with the
patient and just say this is something that because she is in a
junior position, she can say, "Well, this is something that
Dr. so and so should really be talking with you about."
DR. KOPELMAN: Okay.
DR. ROWLEY: I think the other thing is that the
parents really have to be educated, that it's going to be in
everybody's interest in the long run, particularly if the patient
goes on some kind of experimental therapy that's going to make
him very sick, that the patient has to be involved in this. And
they've got to learn that this is in their best interest as
well as their son's best interest.
DR. McHUGH: Although I agree with that, ultimately,
this, having things like this sprung on you, is not an unusual physician's
experience. And most of the times, physicians answer promptly to
this, saying, "I'm very distressed to know that this is
on your mind. And we need to talk with your parents about why you
are still worried about this."
Just as if somebody says to you, "Where do babies come from?"
they're 14 years old and you can't tell you, you don't
immediately say, "Well, let me explain it to you. There's
this anatomy and this structure and the like" even though they
eventually have to know those things.
DR. KOPELMAN: Let me tell what happened. I mean, this
is a house officer who in that situation, she just froze. She said
she just froze. And the 14-year-old was good enough at reading
the signs of that. And he said, "You know, don't you?
Why don't you tell me?"
And so she probably should have said, "Well, I'll get
together with you tomorrow. I'll get the attending. We'll
talk with your parents." But she didn't. She blurted
it out. She felt very badly about it. She didn't feel very
pleased about her performance.
On the other hand, I should say that that 14-year-old bonded with
her forever because she had told him the truth. So the two of them
formed a bond, and that was really very important.
If she had said something like "I don't know," that,
of course, would have been a lie or,at best, a deception, and she
didn't want to go that route. So that's what happened in
that case. And she wondered whether she had done the best for this
Increasingly, in the last generation, last 25 years, assent from
minors has been considered more and more important in therapy and
research. It acknowledges their emerging self-determination and
acknowledges that competence is task-related.
A lot of this grows out of social science studies about what children
do understand, how they are pretty good at reading what is going
on, even if people aren't talking to them.
And there's one set of studies from Dr. Bluebond-Langner published
in 1978. This was her Ph.D. dissertation. She asked permission
to go to a cancer unit and be like a fly on the wall and not interact,
just be an observer.
What she found was an elaborate system of mutual pretense, where
the doctors talked to the parents and nobody talked to the children
but the children didn't want to make it worse for their parents
by telling them they knew. They were trying to protect their parents.
The parents were trying to protect the children by not telling them.
And it was not making good sense.
The children were still trying to gather information by relatively
ingenious means. They would post guards and steal the chart, which,
of course, then was a paper chart. And then they would steal it
and run back to their rooms and read it with flashlights under the
covers or they would put tape recorders in conference rooms and
have an elaborate strategy for how to turn them on while the discussions
were going on.
And then they would inform each other, "Well, yes, of course,
you've got cancer. This is a cancer unit" and what everything
meant, what the different — of course, it was all wrong.
So they figured, well, it's probably better if they were talking
among themselves that, actually, they get good information, rather
than bad information.
PROF. GEORGE: Dr. Kopelman?
DR. KOPELMAN: Yes?
PROF. GEORGE: How was this information gathered? She
was a fly on the wall, and she observed them with flashlights —
DR. KOPELMAN: She just observed —
PROF. GEORGE: — under the covers and —
DR. KOPELMAN: Yes, or they told her about it.
PROF. GEORGE: — stealing charts and things? Okay.
Has this been replicated? I mean, why should we believe all of
DR. KOPELMAN: I think it certainly has been replicated
that children know a lot more than they let on, I mean, that they
can read people pretty well, when they're being truthful and
when they're not. They can read cancer, you know, if they get
over five or six years of age.
So there's a growing body that children do understand quite
a bit of what is going on and that they feel very isolated if they
can't talk about the things that trouble them.
PROF. GEORGE: Well, I understand that is what is being
reported, may very well be true, but I am interested in whether
we really have rigorous data. These kinds of things are put forward
as scientific studies. I would like to be able to assess their
DR. KOPELMAN: There is a review in the Institute of Medicine
research with children, quite a long chapter with a review, all
the evidence for what children understand, who gets assent, when
we should get assent. I don't know. They must talk about 50
or 60 studies in that chapter.
And some of them, the difficulty with children is that you need
to make the information age-appropriate. And what you're going
to tell a 14-year-old will be different from what you want to tell
a 6- or 7-year-old.
But the people who do these sorts of things — I'm a
philosopher. I'm not a social scientist — say that it
does foster trust and cooperation, and it makes them feel less isolated.
The American Academy of Pediatrics recommends gaining assent from
children when it's possible and prudent to do so. And the greater
the benefit, minors' views should carry weight but not be decisive,
as it would be for an adult.
And the greater the benefit to the child, the more justification
for overriding a minor's unreasonable refusal or demands regarding
therapy. Assent in research is generally required when it's
possible and when there are no direct benefits to the child.
Many people write in "no benefit" studies the child's
dissent should trump. And I would echo Norm Fost's skepticism
about how often that really happens. A five, six, seven, eight-year-old
isn't thrilled about getting stuck one more time or a spinal
tap one more time or any of the other things that are considered
minimal risk and no benefit research.
So, again, in this chapter on the Institute of Medicine, they
review just how many times IRBs do have a mechanism for looking
at assent and dissent. I don't think we get very high grades,
but I think we are probably doing better than we did when Bluebond-Langner
first started to do her studies.
Consent from older minors is sometimes permissible for treatment
of some conditions; for example, treatment of sexually transmitted
diseases, treatment for substance abuse. And also for some minimal
risk studies, the FDA doesn't permit waiving parental consent,
but HHS sometimes does.
This brings me to another case selected by one of the house officers.
It involves a possible conflict between what the parents want to
know and what the adolescent wants them to know.
K. L. is a 16-year-old female patient being seen in the adolescent
clinic. When her mother leaves the room, she tells her doctor she
has been having unprotected sexual intercourse and wants a prescription
for birth control medication.
For a variety of personal and religious reasons, she does not
want her mother told. Her mother, however, has told doctors she
wants all the information about her daughter.
Now, in this discussion of this case, everybody agreed this was
certainly a teachable moment for the clinician to talk to this 16-year-old
about, you know, "What are you doing with your life? Who is
this person? You know, what is going on?"
But the question was, should they tell the mother? Should they
not tell the mother? Should they write the prescription? Should
they send her to the health department and kind of wash their hands
of it? That was the case presented for discussion. I think this
was about six months ago.
In the State of North Carolina, doctors may make these prescriptions
without — it varies between the states, but they are permitted
to do this without parental consent in North Carolina.
Any questions about this case?
PROF. DRESSER: Well, one of the things that I think
would be important to think about and often I've just noticed
in discussing cases like this about whether to impose certain things
on children in the medical setting is how will this affect their
long-term view of medical care and their trust in the medical system.
So I think that's one factor that makes cases like this very
DR. ROWLEY: Yes. Well, I guess I would make the
comment that this young girl is going to get pregnant sooner or
later if she continues this kind of activity.
And then she is going to be in the situation either of having
an abortion and trying to get that done without her parents'
knowledge — I don't know what the rules are in North Carolina,
but it's difficult in many states — or, alternatively,
she then is going to have to confess that not only has she had intercourse
but now she's pregnant.
And I think that at 16, she ought to be in a situation where she
understands this. Clearly she understands it to some extent because
she wants a prescription for birth control.
I think the other point that you raised in terms of trying to
educate her about how her behavior is going to influence her whole
life is something that really has to be hammered home.
I would agree with Rebecca that it seems to me difficult to tell
her mother without the agreement of the patient.
DR. KOPELMAN: So you would honor confidentiality, tend
to honor? See, I mean, we can all agree with the important values.
The question in all of these situations is, which one do you rank
PROF. MEILAENDER: I have a question, and then I
have a comment. What would be a religious reason for not wanting
her mother to be told?
DR. KOPELMAN: Well, this is according to the resident.
The daughter said that her mother belonged to a religious community
where if someone had sexual relations outside of marriage or was
unfaithful to a husband or wife, that that person was shunned and
if her mother knew about her sexual activity and didn't tell
the elders, her mother would be shunned.
Now, according to the resident, the daughter did want to separate
herself from that community. On the other hand, she wasn't
keen on being shunned. And she didn't want to have her mother
be shunned either.
So she felt that that was yet another reason for honoring her
PROF. MEILAENDER: Well, I understand that. I think
that would be very peculiar to call that a religious reason. It's
a reason having something to do with her relation with her mother
and that's affected by some religious commitments her mother
has made, but one wouldn't ordinarily call that a religious
reason. That's all.
DR. KOPELMAN: Fair enough.
PROF. MEILAENDER: But my comment is that I think
it's just inadequate, finally, to take up a case like this simply
in the language of consent and trying to figure out and confidentiality
and so forth as if it's ever a purely individual matter with
whom we're having sexual intercourse as if it isn't important
in a society for us to know that this person is my wife and, therefore,
not eligible to be somebody else's wife. So that this is never
a purely individual matter, in fact.
And there's something about the way taking up this case in
this kind of context thins it out that loses considerations that
are at least as important as consent and confidentiality I think.
DR. KOPELMAN: Well, the discussion among the residents
centered on —
DR. McHUGH: Can I ask another question?
DR. KOPELMAN: Sure.
DR. McHUGH: To add to what Gil is saying, you mentioned
that this is a visit in an adolescent clinic. We heard from Norman
this morning that pediatricians talk for about 90 seconds to people.
Was this a situation in which 90 seconds of talk was provided and
then, after that, this decision was made or is this, once again,
this individual's natural concerns in life and the issues of
her worries and fears were going to be explored by this group in
the adolescent clinic?
DR. KOPELMAN: The house officer — I can only tell
you what she said. I was not there. She said that it was an occasion
for a discussion, not a 90-second visit.
I asked her, "Well, who is this person she is having unprotected
sex with? You know, is it a 30-year-old neighbor or a 16-year-old
high school student or who are we talking about here?" And
she didn't ask that question.
So I can't answer that because this is a real case and the
resident didn't ask the question. So I can't tell you that
part of it.
I know she did try to talk to her. She took the issues to be
issues of confidentiality and also was this young woman functionally
competent to make this decision. I think Dr. Rowley has suggested
that if you're going to be sexually active at 16, it's probably
a pretty good idea to use birth control. I'm not sure the resident
was able to sway her, talk her out of this.
So here I picked this case. I didn't mean to spin anything
out. It is a real case. The resident has a choice. The attending
has a choice to make within the framework of the current health
care system, where you don't have a whole lot of time to talk
to patients and what value you're going to put forward.
It is the case this resident picked out. So it was a case which
troubled her. There were certainly people in the group who thought
that it was terrible that she was having this sexual intercourse
outside of marriage. And they were more sympathetic to talking
to the mom. But I think there were only one or 2 people who expressed
that view in a room of about 45 or 50.
PROF. GEORGE: Well, I agree with Dr. Rowley that if she
keeps doing what she is doing, she is going to get pregnant. If
she is given birth control devices or pills, she will be far less
likely to get pregnant, although she may, nevertheless, get pregnant
because of the failure rate. The only way she is not going to get
pregnant is if she stops doing it.
Now, was it assumed or, for some reason, believed that the mother
if armed with the information about what her daughter was not herself
competent to prevent her daughter from continuing to engage in this
DR. KOPELMAN: I did not have that impression from what
the resident said. I had more of an impression that there was already
some tension between the daughter and the mom because the mom is
saying, "Now, you tell me what is going on with my daughter."
That was sort of that was my impression. And the house officer
felt like she was kind of trapped between the mom and the daughter.
PROF. GEORGE: But it wasn't out of the question that
the mother might very well be competent to handle her daughter if
she had the information.
DR. KOPELMAN: Maybe.
PROF. GEORGE: The second question I had is, would it materially
change the thinking of people confronted with something like this
if we had one additional fact, and that is the person with whom
she is having sexual intercourse is her mother's boyfriend?
DR. KOPELMAN: Well, that's why I asked at the conference.
I said, "Who is this person?" I mean, it would certainly
make a difference, as far as I'm concerned, if it was someone
who was, say, four or five years older.
PROF. GEORGE: Well, that was going to be another question.
DR. KOPELMAN: In North Carolina, that is grounds if it's
a minor for rape, not statutory, rape, if the —
PROF. GEORGE: And would the person who came into possession
of the information be required to report it to the authorities?
DR. KOPELMAN: Yes, if it's abuse and neglect.
PROF. GEORGE: And that would be —
DR. KOPELMAN: I'm not an attorney either.
PROF. GEORGE: No. I understand.
DR. KOPELMAN: I am not a social scientist. I'm not
PROF. GEORGE: I understand. And the same would be true
if it were incestuous so that it was not the boyfriend of the mother
but the father of the girl?
DR. KOPELMAN: Yes.
DR. McHUGH: It seems to us or at least to me that
you need to instruct the residents on how to interview patients
so they get the pertinent information. It would help them a lot
in how they are deciding.
DR. KOPELMAN: I think that is true, but they're not
my residents. I'm medical humanities. But I think the value
of these cases is that all the residents, the 45 of them sitting
in the room in the faculty, say, maybe for next time they'll
think to ask a question, "Well, who is it that you're seeing?
Is this someone who is five or six years older than you?"
And frequently we don't — I mean, clinicians have to
make decisions with — they don't have the full story and
they have to make a decision based on what they have before them.
DR. McHUGH: Well, that is ridiculous. Physicians
are supposed to get the whole story before they do something that
is significant. You have to get a whole story about somebody's
abdominal pain before you take a knife to it and, similarly, to
their lives themselves in the process of really winning the trust
that you want people to have for the profession.
DR. KOPELMAN: I take your point. On the other hand, the
16-year-old may not tell the truth either. So you're not going
to get the whole story without winning her trust beforehand.
DR. McHUGH: That's a standard issue and a standard
problem that develops out of an interactive process done by sympathetic
DR. KOPELMAN: Right.
DR. McHUGH: — with individuals of this sort
by making it clear to them that there are issues in this matter
that are important for them that the doctor could perhaps help them
DR. KOPELMAN: I think something I should have said earlier,
of course, consent and assent are not an event, not a form. It
is an ongoing process where you win trust and you learn more information.
And if this house officer sees this young woman again, maybe she
will hear more of the story and will win her trust and confidence.
I think the point here is that the involvement of the adolescent
is important. Their capacities are emerging. Their point of view
is differing from their parents. I think that was the point of
this case. At least that's the point I was trying to make.
PROF. LAWLER: Let's say that our standard is the best
interest. Can we agree that the house officer here did not have
nearly enough information to make a judgment concerning the best
interest of this young person?
This is a very serious flaw if, in fact, she wouldn't go ahead
and give her information on birth control and so forth.
DR. KOPELMAN: I think that's at the heart of this problem,
not only in the case of the 14-year-old, what should he be told,
but in the case of the 16-year-old. How should she be treated when
she requests birth control medication? Is it in her best interest
to get it or not?
I think I hear a little bit of disagreement around the table.
And I think that's what makes this —
PROF. LAWLER: Let me ask you, what kind of standards do
you think should be in place for a case like this?
DR. KOPELMAN: I would want to check in this case who —
to me, very important information is who is she having sexual relations
with. If it is someone five years older than her, I think you have
a duty to report.
Now, you may lose trust. She may never come back. But there
is so much abuse, sexual abuse, of teenagers that, you know, I think
we need to work on that.
Okay. One more case. This is the last case. This is a child
with a very serious condition called holoprosencephaly. It is an
anomaly that develops very early in fetal development. And it is
the failure of the lobes of the brain, of the cerebral hemisphere,
to divide sufficiently.
And there's this range. There's this spectrum here from
severe — the most severe die in utero — to the least
severe, which is there's an incomplete separation, but some
of those children with the least severe versions are near normal.
They have mental retardation.
The case three is an infant who has a very severe form of it.
And the question here once again is, what is the best care? What
is in the best interest of this infant?
Since birth, ten-month-old K. D., who has a diagnosis of holoprosencephaly,
has reacted only to painful stimuli. K. D. is admitted to the hospital
with edema. He is found to have renal failure of unknown cause.
Doctors determine that his kidney disease can be managed with
renal dialysis but not cured. Is it required? Is it optional or
counter.indicated given his underlying condition? Who should decide
what is the best care for this child?
The residents who picked this case gave us some background about
the family. There were four children. There is an older brother
who has a milder version of holoprosencephaly. And the two boys
with this condition are being cared for by the mother and two teenage
So there are four children in the family. And the two daughters
and the mom are providing the care for these boys, one of whom is
severely retarded and one who is not. He's still mentally retarded,
but he doesn't have as severe a case as this one.
So K. D. can live for many, many years with the dialysis and will
not live very long without it. So the question is, is it obligated,
is it required or is it counter-indicated?
Are there any questions you would like to ask about this case?
DR. ROWLEY: Well, I suppose one question is, what
is the financial status of the family just because if this —
and everybody can fault me for saying that is not the ethical issue,
and I understand that. But I tend to look at these issues in terms
of the whole family and what would be the impact of having to take
a child presumably three times a week or so to a dialysis clinic
for some several hours each time for the dialysis.
And these treatments, though there is some federal support, I
believe, for this, can be very demanding. And though it should
not be the determining factor, I think as one looks at the family
as a whole, that is a consideration that one would like to know
in making the decision.
DR. KOPELMAN: I don't have that information. I'm
sorry. It was not something the resident brought up.
PROF. DRESSER: I assume this point about only reacts
to painful stimuli means that the child — is it himself?
DR. KOPELMAN: Him.
PROF. DRESSER: — would not experience burdens
from the dialysis.
DR. KOPELMAN: Well, I don't know.
PROF. DRESSER: Maybe a little.
DR. KOPELMAN: They're restrained. Wouldn't they
have to be restrained? In Taking Care, you wrote that
a majority of patients don't think life is good on dialysis,
that sometimes they draw off too little fluid, sometimes too much,
the clot gets infected.
So I don't know for a fact that it would be pain-free. But
this child is minimally conscious. And the only thing he seems
to react to is painful stimuli.
PROF. DRESSER: Okay. So it's just that we
would perhaps want to know more about the experiential burdens that
he would have.
DR. KOPELMAN: As far as the residents and the attendings
could tell, he only reacted to pain.
DR. GÓMEZ-LOBO: Would a child who is normal be
given the dialysis in this case? In other words, any failure to
give the dialysis would be based exclusively on the holoprosencephaly?
DR. KOPELMAN: I would think that is probably true.
DR. GÓMEZ-LOBO: Then it is parallel to the Baby
Doe case, isn't it?
DR. KOPELMAN: And I am going to actually talk about Baby
Doe in the next section. I think it's interesting that all
three of us were given whatever topic we wanted to talk about and
all three of us talked about the Baby Doe regulations. Whether
this child would meet the Baby Doe regulations or not, I can tell
you what happened in this case.
In this case, the physicians, just as in the case you talked about
in Taking Care, they decided it was optional and they would
leave it up to the family. And the family chose to have the dialysis.
That was the outcome of this case.
They all agreed that if the family had said, "No, we do not
want to have the dialysis for K. D.," that they would have
gone along with that as well.
PROF. MEILAENDER: May I still pursue that case
for just a minute?
DR. KOPELMAN: Yes. I am not sure I can get back. Well,
PROF. MEILAENDER: I am just curious what the answer
to the question would be if — I mean, Rebecca had said that
we would ultimately need more information about the way the dialysis
was experienced by the patient himself, but if the dialysis did
not seem to be burdensome to the patient, didn't seem to respond
as he did to some other painful stimuli, and if it was clearly useful
in prolonging his life and would have been done for a child who
didn't have this disability, then what would the answer to this
question be? If you're not going to dialyze the child, why
DR. KOPELMAN: What would be the reason for regarding it
as optional? Why did the doctors think it was optional? Is that
what you're asking?
PROF. MEILAENDER: I would prefer to sort of fill
in the blank, "I'm not going to dialyze this child because"?
DR. KOPELMAN: I think the one thing to consider is what
would you want for yourself in the similar setting. If you were
minimally conscious, could only react to pain and that's how
it was going to be forever, what would you want for yourself?
And if you think we should do unto others, if we should apply
the Golden Rule, then I think I could accept someone saying, "I
wouldn't want this for myself. Therefore, I shouldn't inflict
it on others" or someone saying, "This is what I would
want for myself. Therefore, I think it's the right thing to
do for others."
PROF. MEILAENDER: Well, see, I wouldn't put
it quite that way. I wouldn't think of it quite that way.
I would say, "Since I am a human being, I would not want any
of my fellow human beings to decide that they wouldn't do this
so that I would die. And, therefore, I should not make similar
decisions about other human beings." Do you see that?
The question is how you fill in that blank in the sentence. If
you fill it in by saying, "I'm not going to do this so
that he goes away, so that his life of minimal capacity ends,"
then that is not whether I would want that done for me or not.
It's whether I think that should be done to any human being.
DR. KOPELMAN: Well, in making my choice, though, it seems
to me in some sense I am saying, "This is what I would not
want for myself because there would be burdens and no benefits,"
as far as I can see, for myself or anyone else.
PROF. MEILAENDER: But by hypothesis, there aren't
DR. KOPELMAN: Yes, there are.
PROF. MEILAENDER: Not to the patient.
DR. KOPELMAN: Yes, yes. He senses pain.
PROF. MEILAENDER: But I began by saying at least
in lacking other information, we have no evidence that he experiences
the dialysis as burdensome.
DR. KOPELMAN: Well, we know he experiences procedures
as painful. That's his whole life, is pain. And, as I understand
it, at least from reading Taking Care, it's burdensome.
PROF. GEORGE: I think it would help if we were clear on
what the "it" is that's burdensome and what the "this"
is when we say we wouldn't want "this," "I wouldn't
want this for myself. Therefore, I wouldn't want this for others."
Is the "this" and the "it" this life under
these conditions or is it this treatment, which in the version of
the hypothetical I think now on the table is painful? Is it the
latter or the former?
DR. ROWLEY: Well, I am the last person who should
be discussing this, and it's too bad Dan isn't here. But
dialysis does involve the circulation through a system of blood
to reduce the amount of ammonia and other — Ed, you probably
know as well or Paul — things that are toxins in the blood.
And you remove these through the dialysis apparatus.
So you do either have to have, I believe, some kind of an in-dwelling
line or each time you have to be stuck to be hitched up to the instrument.
And the child is almost certainly going to have to be restrained
for four or five hours three times a week to undergo this. So this
is not a trivial procedure.
PROF. GEORGE: So does that mean that the "this"
is the burdensome treatment, not the life?
DR. ROWLEY: Correct.
PROF. GEORGE: So that if we shift the hypothesis back
to where Professor Meilaender opened, had it in his opening comment,
and there were no particular burdens or he couldn't feel them
or experience them, then there would not be any reason not to go
forward with the dialysis?
DR. KOPELMAN: That is another case. The case I'm
talking about, there are painful burdens. But if it was an intervention
where there was no pain involved, then it would be far less problematic,
I would say.
DR. KASS: I probably should keep silent on this,
and I will probably regret it, but Gil and Robby could find some
way to administer sufficient anesthesia or some kind of narcotic
to eliminate the pain to make it a pure case to prove the principle,
but I think there is something finally weird and even cruel to treat
a child who has, as far as we know, nothing but a reaction to painful
pressure as a continuing biological preparation to uphold the principle.
And I don't see the compelling reason for saying the condition
here doesn't somehow count. It doesn't make sense to put
this baby on dialysis. If you then have to give the reason for
not doing so, you might be embarrassed. And I have owned up to
my embarrassment on this point multiple times.
But this is not what medicine is supposed to be doing. And unless
you want to say every conceivable intervention which could be rendered
non-burdensome to this little infant becomes morally obligatory
because not to make it morally obligatory is to wish them dead,
then we've got something wrong in our thinking.
PROF. LAWLER: All right. This, though, was not such a
great case because the case is about this. This little human being
experiences life as nothing but pain and will be subjected to a
procedure which will bring more pain.
I have to say this is very difficult. I understand what Leon
is saying about this. And I might even be sympathetic as long as
you wouldn't generalize from this case to any other case if
life is 98 percent pain and the danger is caving on this. If Robby
and Gil cave on this, then what about a 10-month-old baby who is
quadriplegic, a ten-month-old baby who is severely retarded, at
what point do we say, then, the quality of life is so low the dialysis
makes no sense?
I'm jumping to the extreme case and pulling Leon's heartstrings
that hard, you know, you can't help but feel sympathy for a
position. On the other hand, Robby and Gil might say, "We're
not going to cave on this one" because in caving on this one,
then, in fact, it becomes a part of drawing the line. What percentage
of life would have to be painful before you would say dialysis would
make no sense because this is a genuinely extreme case where life
is nothing but pain. How many cases like this are there?
DR. KOPELMAN: Well, I think we can ask the neonatologists
here. They're not that uncommon.
PROF. MEILAENDER: I just want to clarify. You
have, alas, walked into a longstanding discussion and just found
yourself in the middle of it. And I sympathize with you at this
point, but that doesn't mean I'm willing to stop exactly.
DR. KASS: I just didn't want their to be the
impression there was unanimity around the table in the way in which
the conversation had been going. So I kept silent.
PROF. MEILAENDER: I understand. But I think if
doing this to this child is — if we have some reason to think
that it is placing burdens on that poor little child's life,
that is a decisive factor, as far as I am concerned.
But it's not a question simply of sort of trying to uphold
a principle, Leon. The Taking Care report, from which
you have gone to the trouble actually to read and to quote, makes
clear that these individualized decisions take place within a framework
that is governed by certain nonnegotiable principles. And one of
those has to do with not just trying to make people's lives
go away finally.
So it's not that one makes one's decision about the case
in order to try to uphold the principle. It's that we have
certain principles that shape our whole understanding of how we
think about cases and what we are doing. If we didn't have
them, we would think about cases entirely differently.
So, I mean, I think it's wrong to describe this as just an
attempt to save a principle. It's an attempt to allow our thinking
to be shaped by ways of looking at cases that are not simply ad
hoc but that recognize our common humanity.
DR. KOPELMAN: As I read Taking Care, I was struck
with how much better off infants would be with the principles that
you enumerate there than the Baby Doe regulations. The Baby Doe
regulations are technically for infants under one, but they create
a certain mindset in pediatrics for a lot of intensive care, too.
PROF. LAWLER: In your opinion, the Baby Doe regulations,
then, would compel the doctor to put the kid through dialysis, even
if dialysis was very painful?
DR. KOPELMAN: I have the Baby Doe regulations. And we
can talk about that case when we have the Baby Doe regulations up
on the board. We could just postpone that a little bit.
PROF. GEORGE: I won't hold us up very long. I just
wanted to clarify one thing. I appreciated Dr. Lawler's comment,
not only this most recent one but the one before it, which is the
one I am referring to right now.
I understand it and agree with the point he was making, but let
me just ask you if he was accurate in his understanding of the case
you had in front of us. I thought you said that the baby in the
case only responded to painful stimuli.
DR. KOPELMAN: Correct.
PROF. GEORGE: I think perhaps Dr. Lawler interpreted that
as meaning that the baby experienced nothing but pain in the sense
of experienced pain all the time, was under constant unpalliated
pain. Now, that wasn't what was going on, right?
DR. KOPELMAN: No. As far as anybody knows, you can't
really ask the baby.
PROF. GEORGE: Sure.
DR. KOPELMAN: But, as far as anybody knows, heart rate
goes up, you know, have a reaction to pain like others do as far
PROF. GEORGE: Yes. Those would be two different, —
DR. KOPELMAN: Right.
PROF. GEORGE: — interestingly different —
PROF. LAWLER: That's right. I mean, so it's long
periods of calm with break-ins of pain.
DR. KOPELMAN: Minimally conscious.
PROF. LAWLER: Yes.
DR. KOPELMAN: So that they come to consciousness only
when there is pain is as best as anyone can tell.
PROF. GEORGE: Okay.
DR. KOPELMAN: Well, I quoted from you because I did think
that the principles you enumerated would be very useful. The goal
of caregiving — is it a bore to quote you back to yourself?
I hope it's not. Anyway, "the goal of ethical caregiving
in the clinical setting is not to extend the length or purpose or
postpone the end of a patient's life as long as it is medically
possible but always to benefit the life the patient still has."
So you look in terms of burdens and benefits, which I agree with.
The clearest ethical grounds for foregoing life.sustaining treatment
are an obligation to avoid inflicting treatments that are unduly
burdensome to the patient being treated and an obligation to avoid
treatments that are not at all or not any longer efficacious in
obtaining a desired end.
So I come now to choosing policies that support flexible and individualized
choice using the best care or best interest standard. The Child
Abuse Prevention and Treatment Act had amendments in 1984 that are
widely regarded as the Baby Doe regulations. It requires maximal
treatment for infants under one year unless in the reasonable medical
judgment of a physician one of the following apply: chronically
and irreversible comatose.
As Dr. Nelson said, this is very difficult to determine in the
newborn period, as is persistent vegetative state. So as a condition,
as a criterion for discontinuing, this is going to largely not be
used very often.
Treatment would merely prolong dying, not be effective in ameliorating
or correcting all of the infants' life-threatening conditions,
or otherwise be futile in terms of the survival of the infant.
Now, I would say the case we just discussed does not meet the
first condition. He's not in a coma. He's not in a persistent
vegetative state. And the treatment would not prolong dying. He
could live for many, many years with the dialysis.
Third condition is the provision of such treatment would be virtually
futile in terms of survival. And, again, he could live many, many
years for this. And the treatment itself under such circumstances
would be inhumane. There is no separate consideration of what is
inhumane in itself, only in relation to whether it's virtually
futile in terms of survival.
Now, a survey that my husband and I and another colleague did
soon after the Baby Doe regulations went into effect, the neonatologists
from the American Academy of Pediatrics, all of them were sent the
survey and a sampling of pediatricians. Other kinds of pediatricians,
in the academy were sent the survey.
We had a pretty good response on one mailing, almost 50 percent.
They argued that standards of care were immediately altered. They
thought it gave, these rules gave, too little weight to the infants'
pain and suffering, too little weight to parental views and to clinical
judgment, the ability to make flexible individualized choices.
Now, there have been a lot of surveys of adults. Most adults
want individualized decision-making for themselves and the opportunities
for their families and doctors to give adequate pain medication
to fulfill palliative goals.
Most adults do not want to prolong minimally or permanently unconscious
lives for themselves. And the Baby Doe regulations are really pretty
strict in not allowing for discontinuation of treatments unless
the infant is in coma or is dying or very likely to be dying.
So the question is, do the Baby Doe rules set up a standard different
from the best care and best interest standard? I would argue they
do. In the survey — again, this is a 20-year-old survey,
but nobody has done one since. Maybe it's time to do it again.
Up to a third thought the Baby Doe rules and the best interest standard
were different in one of the cases. We had three vignettes. And
in one of the cases, a third of them thought that they were required
by the Baby Doe rules to treat that baby in a way that they did
not think was in the infant's best interest.
Do they unfairly single out one group for rules that others of
us do not want? It seems to me fair that if we're going to
have Baby Doe rules for babies under one, then we should all have
them. If you're not going to trust the families and the clinicians
for babies under one, why should you trust them for 50-year-olds,
60-year-old, 70-year-olds, or 80-year-olds?
So, I mean, I would argue it's not fair to have unless somebody
can make a case a set of rules for just one age group. Does it
ignore duties to prevent unnecessary suffering?
Most of the neonatologists and pediatricians, I think it was around
75 percent, thought it did, gave too little consideration to suffering.
Did it give too little attention to parental views? Again, most
of them thought it did.
Did it unduly restrict prudence, the ability to make a here and
now decision considering the facts of the case? Does it give too
little consideration to clinical judgments? And, again, most thought
Now, in the case we have just been talking about, one of the residents
suggested, "Well, you know, maybe we should give this baby
dialysis for three months. When they get out of the range of the
Baby Doe rules, then we'll quit, you know." And I would
suggest to you doing that is probably not making the right decision
in the right way for the right reasons, but anyway.
Here is my concluding slide. And I would suggest that to the
extent possible, the same goals and values apply to health care
for the elderly with diminished capacity that you enumerated in
Taking Care should also apply to minors. We should consider
the values of what is going to benefit and what is going to do no
harm and foster individualized decision-making by families and clinicians
using the best care or best interest standard.
And, as I said when I introduced this, I don't think you can
use the best care or the best interest standard without some kind
of social consensus about what kinds of choices are unacceptable.
It presupposes a consensus, and it also presupposes some frameworks
of rights for the individual and duties to those individuals that
are pretty well enumerated or understood.
We should also consider the value of autonomy in honoring assent
or refusals of minors if they're reasonable. And I think that's
a point you make as well with people who have diminished capacity
but have a point of view among the elderly.
As issues of justice, we should treat similar cases similarly,
different cases differently, and the differences and similarities
should be relevant. I suggest to you being under one is not necessarily
relevant in and of itself for a different set of rules.
Another point about justice, of course — that's a formal
condition of justice to treat similar cases similarly. Another
formal condition of justice, which Aristotle clarified for us, of
course, is that a just system creates the opportunities for justice
to thrive and encourages good people to act well and perform their
I think you heard a lot of angst this morning from intensivists,
from neonatologists about the difficulty of not being able to do
what they consider to be in the best interest of children, provide
the best care, because of rules which they perceive as thwarting
in some cases the best interest standard.
This was really brought home to me in a case conference we had
about six months ago. A woman gave birth to very premature twins.
One of them did well, and one of them was doing extremely badly.
And I cannot remember the details of the case. I'm sorry.
But there was a case conference with about six or seven family
members. One of them was a nurse on a palliative care unit and
one who is a pulmonologist. They were very used to dealing with
dying adults. And they said, "Well, maximal treatment in this
case is not in the best interest of this infant."
The three neonatologists present agreed, "but" they
said, "We feel obligated to follow the Baby Doe regulations.
So we can't do anything." The family expressed shock that
there should be such a difference in the treatment of adults and
the treatment of infants.
So I think that's to me, in part, a justice issue, not only
treating similar cases similarly but are we encouraging good people
to do the right thing in the right way for the right reason with
this very inflexible rule?
And then I would just mention one other value of generalizability
or consistency. Are we treating others as you would want to be
treated if you were in the situation of that infant?
I'll be happy to take any further questions you have. I'm
sure there are some. Yes?
DR. GÓMEZ-LOBO: Well, I couldn't agree more
on the conception of justice that you set out, but it seems to me
— and you may correct me if I'm wrong here in the information;
I'm new to most of these topics — that precisely the Baby
Doe case was a case of severe injustice. In other words, this child
was treated differently from other children of the same age precisely
because of the Down's syndrome disease or disability.
And that's what prompted this idea, it seems to me, to protect
precisely the most weak among us and protect them, in part, from
decisions made by third parties on whatever grounds, which may be
right or wrong. So I would like to understand a little bit more
the focus here.
The second reason for raising this question is because I understood
Dr. Fost to be in disagreement with regard to interpretations.
In other words, the interpretation of the rules, because it seemed
to me that according to him, these rules would leave latitude for
discretion in certain cases, but I would say it's the protection
of the weak that seems to be or, at least as I understand it, the
focus of these rules.
DR. KOPELMAN: You raise two good points. I'll try
to address them, first one and then the other. What happened with
the baby who came to be known as Baby Doe in Indiana, that was a
terrible thing. I think today there's no question that infant
would be treated.
In the early '80s, when that case occurred, there were very
few intensive care units. There were very few neonatal units.
And, I mean, I'm not defending that case, but we need to think
of it in the context of virtually no intensive care units, no pediatric
intensive care, no neonatal intensive.
Hopkins had one of the few. There weren't that many around
the country. And that's why the case that Norm Fost mentioned
where the baby with the duodenal atresia didn't get treated
was very shocking. Many times if we put it in context of what wasn't
happening to adults, we would be shocked there, too.
So we have moved way beyond that Baby Doe. And I don't think
you would find anybody who would not treat that case today and not
because of Baby Doe rules but because they would view this baby
as having a good opportunity to enjoy life and have pleasures and
interact with people. We know an awful lot more about that genetic
And I think that part of the problem in this is that when people
talk about non.treatment of infants, that case pops into the mind
of a lot of people, "Oh, you're not going to treat an infant
with Down's syndrome. I know all about that"; whereas,
that's not where the neonatal discussions are. It's really
with infants, as far as anybody can tell, life is just a burden
and nothing else. And that's really where the discussions I've
DR. GÓMEZ-LOBO: That is precisely the case. I
think that at that moment, people considered Down's syndrome
just a burden. So has there really been a shift in thinking or
do people still think of life as a burden and not the illness as
a burden or the disability?
DR. KOPELMAN: Well, I am not sure about that. As I understand
it, — maybe Professor Dresser would like to address that —
legal theory was who had the right to decide. And the court said,
"Oh, it's the parents who have the right to decide."
And that's what went up through the Indiana courts.
I think people are much more inclined now to overrule the parents.
And the courts also said, "hey, the doctors disagree about
what is best. Let the parents decide." That was what was
going on for Baby Doe.
Now, was it a mistake? Yes, I think it was a mistake.
PROF. DRESSER: Well, I do think that you have pushed
us into the corner, where it is very uncomfortable. And that is
this question of if we are to adopt a sort of standard of what is
reasonable to allow parents and doctors to decide for infants, what
is reasonable discretion, you know, on the one hand, you can talk
about cases where we would say, "That's unreasonable."
And then you can talk about a child with Down's syndrome and
we can say, you know, withholding treatment is clearly unreasonable,
but that's partly because we live now and there is a different
social understanding of the condition.
So I think we're very aware that to some extent our judgments
about reasonableness are affected by social norms and things that
will change over time. So we don't want to get it wrong. So
I don't know if you — I mean, to me that is the real struggle
with children and with older people with dementia.
Another ingredient with the newborns is uncertainty that I know
I've heard people talk about. With, say, a person with Alzheimer's,
there's a trajectory and you can be pretty certain about what
that person's future looks like; whereas, with the preemies,
as we have heard this morning, you know, there are these statistics.
So you can say, "Well, this child is in a group where, you
know, 20 percent will die, 20 percent will be about average in mental
and physical abilities, and then the rest of them will be somewhere
in between. But we can't tell you where your child will end
up." How does that affect this calculus?
DR. KOPELMAN: Well, yes. You raise a good point. Sometimes
it is clear what the trajectory will be for older persons and you
figure, "Well, if we make a mistake, it's going to be a
mistake of months, you know, not decades, as it might be for the
I think that uncertainty is a very good reason to start maximal
treatment and evaluate. And, as Dr. Nelson said, things sometimes
go wrong very quickly and you get more information. And you can
make a much better particular choice using particular data once
you have good information.
And so I would argue for certainly beginning maximal treatment
if there's any uncertainty and evaluating along the way. But
if we have to treat everybody, just because one percent might do
pretty well, then I would say let's adopt that for all of us,
that you don't have any choice.
If there's a one percent chance, you know, heaven forbid,
that we are incapacitated, no matter what, if there's just a
very small chance we have to do everything, your family has no choice.
CHAIRMAN PELLEGRINO: Dr. McHugh, Dr. Meilaender, and then
DR. McHUGH: Once again, I think you are wonderful
to stand up to this where you come. I've enjoyed your conversation
as well as the meeting this morning.
But I wanted to pick up one theme that you mentioned in your penultimate
slide, where you said we might be unfairly singling out one group
for rules others don't want.
I think that maybe children are the most appropriate group because,
as we have seen historically from medicine, children are individuals
we have betrayed more than many others. And, after all, there is
also a man who holds a chair in ethics at Princeton who thinks that
we should not think of lives of children until they develop their
So I think it may well be that the American public, including
me, feels that the child is lacking in champions and that maybe
we should pick them out as a particular group of people because
they lack the kind of championship that adults get and develop as
they flower as members of a family and a citizen, that maybe there
are certain kinds of times when, you know, that we've just got
to say, "Okay. Here are some rules that we want you to obey.
They're burdensome," all of that, but, you know, that's
what you get when you betray a trust. You get very burdensome rules
put on top of you. And to regain the trust takes a heck of a lot
longer than it does to lose it.
Now, Dr. Fost is closer to the case than I am, but I know a bit
about the Hopkins case because I still talk to some of the nurses
who were there when that case was put in.
The doctors made the decision, but the people who had to be there
with that baby were these nurses. You know, nurses aren't like
doctors. They have other things, wonderful things, that they do.
And we betray them if we don't accept their vocational commitment
and their role in caring for things.
So I've listened to a lot of very good information today,
but there's been a bit of whining about how tough it's become,
not enough acceptance of the fact that, you know, we kind of put
this on ourselves.
So I come back to this idea. Do you think that children have
adequate champions today so that we can be really sure that we can
DR. KOPELMAN: You raised about four or five things. One,
does it unfairly single out one group for rules others don't
want for themselves? And it's I would say rules that others
don't want for themselves should they become incompetent. And
there's pretty good data they don't want to live a life
where they're minimally conscious and just feel pain. They
don't want to live a life where they're minimally conscious,
period. There's pretty good data on that. If we know that's
what competent adults project they want, then I think it also.
That was the point of that bullet there.
Do children under one lack champions? This has been a charge,
I think, that the reason you need the Baby Doe rules is that parents
and clinicians can't be trusted to act in their best interest
and do the right thing for them. And that's why you need a
rule that only allows you to quit or if they're dying or comatose.
I don't find any evidence for that, for that sweeping claim.
If there is any evidence, I don't know data that shows that
parents don't care about their children and are not inclined
to do a better job than some rule which is one size fits all.
I am sorry about the whining if that's what I have been doing.
I don't know. But I do hear a lot of angst from neonatal nurses
and doctors, who feel they are hurting babies and for no good reason
that they can think of.
DR. McHUGH: Look, don't get me wrong. I was
just teasing a little bit there, and I do that too often. What
I meant was that, in point of fact, we got into this problem because
the children were betrayed. And we heard about the betrayals more
today from Dr. Fost, even others.
All I would like to say is that when people begin to say we now
have overdone it, they might say, "Well, we are overdoing it
now because of the things we, we doctors, neglected to do before.
And we're doing our best to make up for that out of the experience
we have. And what more can we do to help you?"
DR. KOPELMAN: Again — should I continue?
CHAIRMAN PELLEGRINO: We have overused our time.
DR. KOPELMAN: Oh, I'm sorry.
CHAIRMAN PELLEGRINO: And I want to get the last three
DR. KOPELMAN: Okay.
CHAIRMAN PELLEGRINO: Could I ask you to answer all three?
DR. KOPELMAN: Certainly.
CHAIRMAN PELLEGRINO: We have Meilaender, Kass, and Lawler,
in that order, with a plea for conciseness.
PROF. MEILAENDER: You have made a kind of comparison
between the Baby Doe regulations and our Taking Care document.
And I want to take that up, fully conscious that the next speaker
in the queue may offer a different interpretation of our document.
Whether the Baby Doe regulations are perfect or not, I don't
know, but they attempt to provide a structure that guides decision-making.
I would say that that is one of the things that we tried to do in
the Taking Care document. That is to say, we wanted to
think through individualized decision-making but within a certain
structure, governed, for instance, by principles such as no deliberate
killing, whether by action or omission, equal dignity of all human
beings, whatever their particular capacities or stage of life, and
that those structure and shape the individualized decisions.
Now, in the paper we had from you on the Baby Doe regulations,
you say, for instance, — I'll quote a passage from it,
a sentence — "Adults facing a choice between prolonging
life and preventing a life of minimal or no consciousness or of
no pain and suffering sometimes believe that there are worse things
Now, it strikes me that that language of "preventing a life"
DR. KOPELMAN: Did I say "prevent"?
PROF. MEILAENDER: Yes. I just read it here.
DR. KOPELMAN: Okay. Yes.
PROF. MEILAENDER: Well, just let me make my point.
You can understand, then, why someone might be worried that a restructuring
would not, in fact, leave in place the sort of guidance that we
suggested might properly shape individualized decision-making.
And that's the worry, not some kind of drive me to the wall
commitment to the notion that the Baby Doe regulations are perfect
and should never be changed but a worry that the kinds of proposals
for reformulating actually wouldn't bear a structural similarity
to the sort of approach we took in the Taking Care document.
CHAIRMAN PELLEGRINO: Thank you.
DR. KASS: Yes. I'm not going to quarrel with
Gil about what we have said. It does seem to me that your plea
not to somehow single out children as a separate group raises an
interesting question for this group insofar as it means to take
up the subject of children. And it's kind of a larger question.
I don't quite know how to get a handle on it, though it's
been lurking at the boundaries of the discussions all day today.
I mean, kind of a dumb way to say it is, what exactly do you mean
by a "child," by which I don't mean what is the chronological
age or how do you recognize them but what is the conception of them
such that we single them out for special consideration?
From my way of thinking, Paul spoke partly to the point where
he talked about that these are amongst people in our society, the
most often abused or betrayed. And Norman Fost this morning spoke
about those horrible figures and that they might be lacking in champions.
But it seems to me it's not just children as members of especially
vulnerable populations, which is the way the bioethics literature
tends to group them, that I think makes them of special interest.
And before I would be prepared to say children are human persons
and, therefore, they come under the general heading of how you treat
human persons, I think it's incumbent upon us to try to sort
out for ourselves what do we mean by taking a special interest in
And here is just one small point. Going back to the case of the
16-year-old girl, some people are concerned as to whether there
is rape here and a question of with whom she is sexually active.
No one sort of I think focused on the question of the integrity
of the family as one of the considerations in the care of children.
Janet referred to it when she spoke about the next case, where she
doesn't want to see just this child in isolation but wants to
think about the well.being and the family.
Here one has to sort of say, "Look, there's a familial
context here, which is also on trial in the presentation of that
case and is one of the things that's to be considered."
If we consider children simply as individuals of a young sort
but not see them as somehow integrated into the natural context
into which they belong, we're missing something.
That's not so much a criticism of anything that you have said.
It's something that the presentation has helped me to see as
something I think we need to pay attention to, Mr. Chairman.
I don't think I need a comment in response.
CHAIRMAN PELLEGRINO: Thank you, Leon.
DR. KOPELMAN: Okay. A brief response. The framework
I have worked in here has been people with diminished capacity,
either because they are minors or because they have dementia.
In both cases, it emits of degree. To the extent possible, I
have argued for honoring their assent. I do think as we are responsible
citizens and look forward to a time when we may have very diminished
capacity, sometimes we do let our families know that we think there
are worse things than dying. And that was the context in which
I made that remark in the Baby Doe rules.
And if we do have strong feelings about that, then I also think
the same values, the same principles we should be prepared to consider
for minors, too.
CHAIRMAN PELLEGRINO: Thank you.
DR. ROWLEY: Can I just make just one small comment,
both to Paul and to Gil? Actually, what Loretta was asking us to
do was to individualize treatment. What she is complaining and
others are complaining about with the Baby Doe is that there is
no room for judgment. There is no room for individualization as
the rules are presently interpreted.
CHAIRMAN PELLEGRINO: Thank you, Dr. Kopelman. I'm
sorry we're a little pressed for time. Thank you for your patience
with this. Obviously the interest in your remarks is very, very
high. And I think it's very pertinent to what we are doing.
Thank you for all the clarifications.
Let's take a few more moments in the break so that we don't
exhaust you entirely before Dr. Goldkind comes on. Let's reassemble
at 5 of 4:00.
(Whereupon, the foregoing matter went off the
record at 3:41 p.m. and went back on the record at 3:58 p.m.)
CHAIRMAN PELLEGRINO: I think we can go ahead probably.
DR. GOLDKIND: I would also like to thank Dr. Pellegrino
and the Council for having me here.
CHAIRMAN PELLEGRINO: Well, I was going to say a word about
DR. GOLDKIND: Okay.
CHAIRMAN PELLEGRINO: Dr. Goldkind is the bioethicist in
the Office of Pediatric Therapeutics within the Office of the Commissioner
of the Food and Drug Administration.
I was surprised to learn that she was the bioethicist for the
FDA. And some of her compatriots, I guess, were surprised, too.
But her presentation was a very impressive one, particularly because
of some of the issues she raised, I thought it would be very important
to have her talk to the Council as we open up the issue of pediatric
ethics, one of them being experimentation with children and some
of the problems as seen from the FDA point of view.
I told Dr. Goldkind please not to limit herself to that perspective,
but to range over other areas.
Thank you for joining us.
DR. GOLDKIND: Thank you for having me.