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 somewhat.

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 an agreement.

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 with.

This is one of those cases.  This is a house officer.  She had been a house officer exactly three months when she encountered this problem.

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 will receive.

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 boy.

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 this?

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 credibility.

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 difficult.

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 higher?

Yes?

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 confidentiality.

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.

Yes?

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 behavior?

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 an attorney.

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 people —

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 with.

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.

Yes?

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 daughters.

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.

Yes?

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.

Yes?

PROF. MEILAENDER:  May I still pursue that case for just a minute?

DR. KOPELMAN:  Yes.  I am not sure I can get back.  Well, okay.

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 not?

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 any burdens.

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.

(Laughter.)

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 as that.

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 they did.

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 duties.

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 condition today.

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 heard are.

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 infant."

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. Kass.

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 personhood.

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 move forward?

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 speakers.

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 than dying."

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.

Leon?

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 them.

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. Lawler?

(No response.)

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.

(Applause.)

(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.  Thank you.

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 you.

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.