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Friday, March 7, 2008

Session 4: The Ethics of Newborn Screening

Discussion of Staff Working Paper

CHAIRMAN PELLEGRINO:   This morning's session will be devoted to a discussion of a staff paper on a subject that the Council has been examining on and off for some time on the ethics of newborn screening. 

This paper is a cooperative effort; however, two members of our staff, Dr. Adam Schulman and Dr. Sam Crowe, have had a major responsibility in doing the research and pulling some of it together for the benefit of the Council members.  I'm going to turn the meeting over immediately to the Council members for their comments on the paper which they have received in advance. 

Drs. Schulman and Crowe are here to act as resource persons, to provide specific answers to concrete questions about the research data, other questions you may want to put to them methodologically and procedurally.  I will now, good morning, open the paper to discussion by the Council members.

We will have a discussion by Professor Alfonso Gómez-Lobo after you have made your first comments, but the opening comment will be by Dr. Gómez-Lobo.

PROFESSOR GÓMEZ-LOBO:   Thank you.  As you know, in our briefing book there are two excellent staff papers, one on the history of newborn screening by Dr. Sam Crowe, which was extremely useful to me because it conveyed information which otherwise would have been very difficult for me to reach, and then there's one on the future of newborn screening by Dr. Adam Schulman. 

Now, my remarks will refer only to the latter just to open the discussion, and, of course, I will concentrate exclusively on the ethical issues.  I'll try to formulate in a little bit of a provocative manner some questions which I think merit some clarification.  And then I will make a modest suggestion on how I would go about answering some of them. 

Now, what makes the moral issues, the ethical issues in newborn screening difficult to grapple with is, as Adam correctly points out, that there is a plurality of issues pulling our judgment in different directions.  There is in the first place the issue of informed consent, then the putative right of an individual "not to know." 

There's also the traditional principle that interventions are justified only if they directly benefit the patient, which it seems is not the case in all of the possible outcomes of screening of newborns.  There's also the potentially harmful effects of having screened a newborn for conditions for which there is no treatment, and also or finally, the negative consequences of genomics, perhaps issuing in eugenicide —a word, I don't know, invented, perhaps, by our staff— eugenicide , which is aptly described as purifying future generations of their undesirable members. 

Now, here's some of the questions:  Is informed consent in this particular area any more problematic than in the rest of the possible interventions dealing with young children?  Is it different in some way?  Don't we have a settled doctrine to the effect that parents may give consent, taking the best interest of their children into consideration— I mean, what they interpret to be the best interest of the children?  That will be one area of questions. 

A second one, is there really a right not to know?  Since knowledge is a human good, a lawful claim to its opposite sounds problematic—at least sounds problematic to me.  And, in fact, it could be argued that in spite of its prima facie negative effects, at a deeper level, it may well be better for a person to know than not to know. 

And I would suggest this:  Even if there's no cure for a condition, does knowledge of it always lead to the risk that the parent will see the child as a defective being?  Isn't it reasonable to think that in some way knowledge that is beneficial to the family and the community at large is also beneficial to the individual?  It's a different way of conceiving the connection between the individual and the common good. 

Finally, does genomic knowledge lead necessarily to eugenicide , or are there morally acceptable alternatives such as simply abstaining from conceiving more children if genetic problems are detected?

Now, the broad framework for the discussion of the morality of newborn screening that I would advance and which needs much fine-tuning is this:  I think we should keep clear in our minds the difference between a human good and the possible misuse that can be made of it on the part of particular agents. 

Genomic knowledge obtained through newborn screening, I would argue, is basically good, and it is reasonable to pursue it, especially if it is not particularly burdensome for the child.  This is an important point for me.  For instance, if the information or if more information can be obtained from the same blood sample, i.e., if there's no special extra burden imposed on the child.  I personally think that it is better to know that there is a risk for a certain disease even if at present there's no cure for it.  Knowing its stages, being able to anticipate the next steps, I would argue, is better than the fear usually generated by ignorance. 

I would also trust that just as a parent may distance himself or herself from the defective child, there's also for that same parent an existential opportunity for the development of the preferential love for the weak child.  On the other hand—these are all points having to do with the good of knowledge—on the other hand, the potential misuses of genomic knowledge should be seen as reasons to erect safeguards wherever they are detected.  For example, the danger of eugenicide should be blocked by legal means that are independent of the expansion of the panel for universal newborn screening.  Likewise, the danger of being denied health insurance because of preexisting conditions should be blocked by legal measures but not by promoting ignorance of those conditions. 

And, of course, there is before Congress the Genetic Information Nondiscrimination Act, which has been passed by the House but is still pending in the Senate.  So that would be an example of the kind of safeguards that can and should be erected. 

In sum, I suggest that the possible misuse of the genomic knowledge obtained through newborn screening will not morally justify limiting the quest for such knowledge.  Thank you.

CHAIRMAN PELLEGRINO:   Open discussion to the members of the Council.  Dr. Dresser and Dr. Lawler.

PROFESSOR DRESSER:   Well, I think there are a number of interesting issues here.  One is I think we have to view this in the context of genetic screening in other areas and testing.  I mean, we have adults who want to be tested for the apoE4 gene predisposing to Alzheimer's.  We have people paying money to find out genetic information about themselves from services, these sort of online services that will analyze your genome—some of it—and millionaires who are now paying to have their whole genome sequenced. 

So there is, at least in part of our society, this interest in knowledge for knowledge's sake and perhaps some useful information.  I'm not sure a lot of people have thought through the downsides, the risks that this will go into your record and so forth.  So I wonder about the level of understanding among people who are advocating universal screening for all these different conditions, many of which can't be treated. 

I know many parents want to know because they talk about being on a—what is it—diagnostic quest or something where they go from doctor to doctor trying to find out what's wrong with their child.  And this would give them some information.  But I guess I'm worried about how thoughtful the pressure to expand screening is among the parent groups.  I also am worried about the research justification. 

So do people really understand that some of the motivation for collecting these data is not to help their child or their family but to advance science?  Now, maybe many of them would say, "Great.  I want other families to benefit from anything we can learn about the illness," but I just wonder if people understand that dual agendas are developing, not just personal benefit to the patient and family but also to society.  And is that something people want to validate and pursue, or do they want to limit this more to a medical justification?  So I would just throw those out.

CHAIRMAN PELLEGRINO:   Thank you, Rebecca.  Dr. Lawler?

PROFESSOR LAWLER:   Well, first off, I want to congratulate both of you for excellent reports.  And the point of these reports, as you say at the very end or Adam says at the very end of his report, is to start a national conversation on this unprecedented problem or unprecedented possibility, too, that has, as Rebecca says, up sides and down sides, and almost all change—techno change—has its up sides and down sides.  And you make excellent use of Alexis de Tocqueville, which is always a sign of your wisdom.  And de Tocqueville says Americans are very self-confident in their ability to handle things.  So no matter how much information you throw at me and you talk about the avalanche of new genetic information, we'll be able to handle it.  But the presupposition is something like this:  We have the wisdom to deal with information, and we do live in an information society.  There may not have been an increase in wisdom that corresponds to the increase in information. 

So parents seem not to particularly want to have this information about themselves .  Somehow they say, "I don't want to know, but I want to have it about my children."  There's two ways of looking at this.  One is that parents are not thinking about their children properly:  "I know in my case I'm better off not knowing, but in case of my kids, it's okay because I'm not really thinking from their point of view.  I'm not really affirming their right not to know." 

But there's another way of looking at it, which I think is more right:  "I can be careless with myself because I've already generated my replacements.  And so if I die it's all to the better; I've already done my job from a Darwinian point of view, but I'm hardwired really to make sure my kids make it at least to the time when they can generate their replacements as nature intends." 

So it's natural for people to be careless in their own cases and very, very careful to the point of being paranoid in the case of their kids, especially in a time when people don't have very many kids and all of those things. 

Now, my own inclination is to think there aren't going to be laws that are going to solve this problem.  If we can know, by gum, we're going to know.  And I think after the baby is born, so to speak—well, not so to speak, literally born—I don't think the problem of bonding and all that is going to be all that big a deal.  People will bond with kids they have seen and loved. 

The right not to know becomes more of a problem in the prenatal stage, which the report doesn't deal with the prenatal stage.  But it begins and ends with saying the problem is much more deep when it comes to prenatal information.  And there it seems to me the right not to know is going to be very hard to exercise because a mother out of love would say, "I just don't want to know.  Whatever happens, I'll be okay with it.  I'll love it." 

Doctors are going to be very insistent that you not exercise that right not to know.  And it's in the prenatal area where tyranny really is possible because until that point you have the problem of being versus not being.  Once the kid is born, no parent—you know , there's not a question of wiping the kid out.  You bond.  And I think Alfonso was perfectly right.  A kid who is vulnerable, diseased, has a very short future—I think you love that kid all the more, if anything.  I just don't really see the practical problems there.  But in terms of the prenatal stage, I'm not talking here about whether abortion should be legal or illegal, but we're really talking here about the right not to know or to do things which would seem from the point of view of health and safety to be irresponsible because they're done out of love.

CHAIRMAN PELLEGRINO:   Thank you, Peter.  I have Dr. Meilaender and Dr. Rowley.  Before I call on them, I'd just like to remind Dr. Schulman and Crowe that if they feel constrained to make a comment or clarification of the report and so on relevant to any of the Council remarks, they're invited to do so.  Dr. Meilaender?

PROFESSOR MEILAENDER:   Just two comments.  One, to second something Rebecca said that seems to me one just needs to think through in order to know what we think about this, and that is that there is in the expansion that is happening and that at least some people would think should happen even more, part of the goal is simply an expansion of our knowledge about diseases or even propensities to disease, and that is a different thing from simply trying to find out something that will help a particular patient or may help a particular patient.  Now, perhaps both of these are—perhaps the added goal of simply expanding our knowledge is perfectly legitimate, but I think that's one of the things that has to be thought through. 

And in connection with the consent issue that Alfonso raised, it's one thing for a parent to give a kind of proxy consent to find out something that might help one's own child.  It's a little different simply to—even if there's really very little risk of harm from, say, a blood sample, it's a little different thing to simply enlist one's child in the pursuit of the advancement of knowledge.  So those are—I do think that's an important issue that Rebecca raised. 

The other thing, I just want to comment in response to Alfonso.  I'm just sort of puzzled.  I'm pleased by your enormous commitment to knowledge, Alfonso, and to the good of knowledge.  I'm not sure I'm quite as confident that it's always a good.  But even granting that, I don't know why each of us is under some obligation actively to pursue all the possible goods that may exist. 

It's one thing to say that knowledge is a good.  It's a different thing to say that each of us must actively pursue it.  There are lots of goods.  We not only don't have to pursue all of them—in fact, you couldn't pursue all of them in a coherent life.  So I just found sort of the strand of that argument a little puzzling.

CHAIRMAN PELLEGRINO:   Alfonso, would you care to respond?

PROFESSOR GÓMEZ-LOBO:   Well, of course, I foresaw the objection and the difficulty.  But, of course, what we're talking about here is, I think, basically the enterprise of science where it would be really very odd to say, "No, we don't want to know A, B, and C."  So what I'm just suggesting is this, is that the broad framework be the positive acceptance of the idea that we can get to know a lot of things at the genomic level and that any possible misuses of that be, you know, carefully monitored so that we have, as I said, safeguards.  I'm not saying that every single one of us should be pursuing genomic knowledge, per se.

PROFESSOR MEILAENDER:   Very quick, but then that brings us back to the issue Rebecca raised and I seconded, whether what we're talking about is the pursuit of genomic knowledge or whether what we're talking about is finding information that may help to treat people with certain problems.

PROFESSOR GÓMEZ-LOBO:   Well, I view it, too, as intimately linked, I would say.  Of course, there is theoretical knowledge, but there is technical knowledge to be obtained there, and by technical I mean medical.

CHAIRMAN PELLEGRINO:   Thank you.  Dr. Rowley?

DR. ROWLEY:   Well, I wanted to make several comments.  First, I, too, think that they're very detailed analyses that the staff has put forward for us.  I have to say that I was, I think, surprised but pleasantly surprised by Alfonso's analysis—thoughtful analysis—and I agree with many of the things that he said.  An important question that we can't get at here in this Council is whether the techniques are accurate, but that is very critical.  And Norm Fost , of course, brought up the concern of false positives and then what that does to families.  And so I think the extent to which the tests can become more accurate is critical. 

I think that we should also recognize that what they're talking about is the detection of mutations of some sort in protein-coding genes, which probably account for, say, 2 percent of our genome.  And what the rest of it is doing in terms of its contribution to us as living human beings is something that science is only now beginning to understand, so that you may have perfectly normal genes, but their epigenetic control may be abnormal.  It's not something you're going to find from DNA sequencing. 

And so that I think that it's a far more complicated situation than is being recognized by people who do newborn screening, and yet it is an issue.  As far as discrimination, there have been bills before Congress, as Alfonso has recognized, that prevent this, and they've been there for a long time. 

I happened to be President of the American Society of Human Genetics when Clinton was President, and there were bills before Congress making it illegal to genetically discriminate against people for genetic information.  And I think that that is important to support in terms of changes in the government so whatever predisposing factor you have is not something that an insurance company can discriminate against you for. 

And I think we also have to recognize we all carry about 7 percent of, if you will, genetic mutations which under certain circumstances could be deleterious but under other circumstances can be very beneficial, so that it partly depends on what your circumstances are as you grow up whether a particular gene is beneficial or not to you.  And I guess, finally, I have the question—I still am not clear that there are substantive ethical issues that really merit the attention of the Council, and I think that other issues such as the one we were talking about yesterday, healthcare and providing adequate healthcare for American citizens, should, in a sense, take precedence, and we have relatively little time in which to pursue some of the issues that are before the Council. 

And I won't say this is a red herring because I don't mean to put you down, but I am very concerned that amongst all the issues we could be concerned with, this would not be at the top of my priorities.

CHAIRMAN PELLEGRINO:   Thank you very much.  Dr. Floyd Bloom.

DR. BLOOM:   Janet made several of the points I thought were worth entering into the discussion, but I'll just add one.  You didn't describe the great Icelandic experiment where all the adults in the population have really agreed to donate their DNA for analysis, along with their health registry.  And it would seem to me that that would speak a lot to the sociology of newborn screening and its implications for adult health and vulnerability to disease just to have that in the record, would indicate that there is not a great deal of resistance, that people really do—at least in Iceland really do want to know what they may be blessed with. 

And it seems to me that body of data isn't really discussed in this presentation, but it does illuminate the whole concept of genetic screening and its potential knowledge base for the future of preventive medicine.

CHAIRMAN PELLEGRINO:   Thank you very much, Floyd.  Dr. Hurlbut.

DR. HURLBUT:   I think we have to be very clear, if we write a report on this subject, that when we talk about newborn screening we're talking about what is already a very mature dialogue in the scientific and medical community, one with a lot of clinical experience and balance of judgment. 

These diseases are really bad news, and to be able to detect them and intervene with them, even if the intervention has no direct medical therapy but some degree of contextual arrangement for the care of the individual, that could be a positive.  I mean, you hinge on the very crucial question in your paper about the transition from testing for things for which there is a direct treatment or not, and my sense is that we can't completely resist that tendency. 

There is something to be said for knowing in advance certain trajectories of development and social realities that will be faced.  So that's my positive dimension.  I think this newborn screening has a very, very strong argument in favor of it and a lot of clinical experience. 

But having said that, I just want to raise maybe in a little more focus some issues that have already been introduced but I think bear some further comment.  One of the things I think we could do on a report, Janet, is help educate the public a little more about the meaning of these kind of tests.  The question is, well, what kind of knowledge are they actually delivering to us.  And whereas the protein tests that are involved in many of the newborn screenings may be a little more straightforward, the coming era of widespread maybe full genome analysis is kind of a different story, and what kind of knowledge do you gain from looking at your SNPs or even your whole genes. 

This is really a complicated subject.  I mean, knowing your genes or particularly the single nucleotide differences within your genes is, at best, a little bit like looking at a great painting and analyzing its pigments.  It isn't going to give you the picture.  It's going to tell you something about the fundamental components out of which the mix of environmental influences, gene/gene interactions, stochastic effects, and so forth have helped to fashion the person. 

So one of the things we could definitely do is to clarify what you can actually gain from such understanding, what do tests tell you, which is a lot less than some people seem to think.  Much of it will end up being statistical because of the complexity of gene/gene interactions, among others. 

And this brings me to another dimension of this.  We have to be very, very careful as a society in introducing worry, not just without direct therapy but worry that just changes the sense of how a parent relates to their child or a child to him- or herself.  It's obviously an invitation to intervention of some kind, even if it's statistical, and that makes it even more complicated. 

Suppose you have a 60-percent chance of some condition or disposition of personality that is negative for, say, educational aptitude or something.  Parents are going to be invited to intervene in ways that may be even pharmacologic at an early age, and what a dilemma that puts people in.  And it turns every child or at least many children into not just research subjects for a wider grasp of knowledge but into patients instead of just children growing up. 

And there could be good in this, but it's a very tricky business because very quickly it could move from an individual invitation to the family to a realm of social pressure.  I think we've already seen this with prenatal screening. I heard of a case of somebody with a Down syndrome child sitting in a park.  Somebody came up to her and said, "Didn't you know about prenatal testing?"  What a horrible thing to say to somebody with a child.  And the pressure, then, that comes on to families to intervene—it could become—yesterday we heard about medicine where more becomes less.  We could end up with something that more is less both medically and socially and even at the core of the individual life.  So I think this is a very important subject.  I think we have a very good realm to comment on here. 

And I just want to say two final things about this.  It's always dangerous to bring up the experience of Nazi Germany, and I don't want to do this in an inflammatory way.  But there is something overarching here that I think is valuable to consider. 

There's an extraordinary essay by a man named Leo Alexander called "Medicine Under Nazi Dictatorship."  I think that's the title of it.  And I don't want to speak of the egregious abuse of human rights of the Nazis, but the more subtle program that allowed this to be pervasive, even within the medical community.  There was a shift of attitude that he describes where medicine went in the mid to late nineteenth century from being really an arena of compassionate care.  The physician would do what they could to arrange things for the patient and then sit with the patient and comfort.  This is our image of the family physician coming and making the house-call while the individual was sick or even died. 

Medicine moved from being a relatively ineffective profession at the end of the nineteenth century to starting to have some really effective interventions.  And this led us from the realm of care and comfort to the realm of treatments.  And then, logically, treatment became early diagnosis and preventive treatment.  And preventive treatment then became prevention of any symptoms with whatever interventions you could do, which is all very, very good and I think is a realm of medicine that still needs to be expanded. 

But there is this strange shift in this process that moves from a focus on compassion and a focus on the deep human realities of what's happening to a much more mechanistic and social perspective on the phenomenon such that you relatively quickly in your inner mind, your general personal psychology and social attitude, move from prevention to a—I don't know quite what the right word is, but it's a preemptive disposition. 

And I'm personally concerned about this because it'll take us time, and as a human civilization we'll mature into this new knowledge.  But one thing we need to bear in mind in this process—and we could bring this out in a report, I believe—is the depth of the human meaning of all of this, the importance of sustaining the fundamental core of what medicine and, of course, all of individual and social life is. 

It's a human, personal process and a collective process that we are not products, and our children should never become products.  We are processes and journeys, and these journeys are inevitably going to involve a dimension of suffering and, as we pointed out in our other reports, frailty and ultimately finitude. 

And this kind of knowledge that we're entering into could change not just the general character of our culture but our internal experiences of what life is.  I've had some experience personally with raising a handicapped child, and whereas I never would have chosen—never in a thousand years would I have chosen and could I have avoided it I would have in the positive sense of avoiding by doing something positive to make my child not handicapped. 

But nonetheless, I have to say that having gone through this personally, it became clear to me very quickly it was an invitation to go deeper into the heart of life.  There are positive dimensions to the humanness, the deepening and enriching of human purpose, the self-giving and the generosity that is involved and the rich human relations that come from imperfect people interacting with each other.  We have to be very careful we don't move from compassion to a cold preemption in all this.  In that sense I think we could write a very meaningful comment on this as a Council.

CHAIRMAN PELLEGRINO:   Thank you very much, Dr. Hurlbut.  Dr. Schaub .

PROFESSOR SCHAUB:   Could I just ask a quick question of Bill?


PROFESSOR SCHAUB:   I'm extremely sympathetic to what you've just said, but at the beginning of your comment you seemed to suggest that it would be impossible to resist this transition from the old principle of "screen only if you can intervene" to the new principle of "screen unless there is a compelling reason not to."  But do you think that the concerns that you've just articulated would constitute compelling reasons to take a stronger stance against the new principle?

DR. HURLBUT:   I think, first of all, you won't be able to resist the—this will become a very inexpensive science, at least the genomic inquiry, I mean, as was brought out in the report.  We'll probably look at the prominent alleles, the most relevant places, for $50 or $100; maybe a thousand , ten thousand, or a couple hundred thousand short segments of analysis will tell us, who knows, 60, 70, 80 percent of the relevant knowledge. 

And I just think it probably not practical to say that parents won't do that because there will be useful information in that.  And I think the larger program of personalized medicine does have a very good scientific rationale.  We can overemphasize it, exaggerate its impact, but I think it's basically—I'm pretty pro-science on this general thing.  It's just that I think we need to walk forward with both legs.  We need to mature into this with our philosophy and our general social understanding, and we can do that.  That's one of the things we as a Council can help our society do. 

I, for one, though, would sympathize with what you said, Diana.  I just feel like—I'm comfortable not knowing some things and comfortable just going forward, but then, I come from a genetic heritage that has relatively little evident burden, and I'm sympathetic to—I'm personally not sympathetic with interventions that are aimed at what the authors of our report have said, quoting Leon Kass , that knowledge then ends up preventing the patient.  I'm not sympathetic—I understand how people move in that direction, but I personally would not do that.  I just think life is enough about a kind of rich experience of light and dark of the sort of chiaroscuro that brings out the drama of life that I'm willing to enter my life in a way that doesn't cut down to the 99.9 percent certainty levels of avoiding all struggle and suffering.  I don't think my life is about MTV. 

I think we have to start re-entering the realm of our deep religious and philosophical traditions that make some sense out of human struggle and human suffering.  Otherwise, I think we're going to be heading into a very cold and mechanistic view of our own lives and a less satisfying, less rich existence.

PROFESSOR MEILAENDER:   This is a really quick sort of addition here, and we don't want to turn this into a discussion with Bill about his views, but whatever such a report might look like if we did it—and I'm still thinking about Janet's comment—Bill, I wouldn't want it to say, "Do it but feel bad about it."  I think that's a useless thing to say, and that's sort of what your response to Diana suggested to me.


DR. HURLBUT:   Maybe I need to comment on that.  I certainly didn't mean to imply we should feel bad about it.  I meant that if we enter with the right attitudes we don't have to feel bad about it.  We contextualize the knowledge both scientifically and socially/ personally.  

And I just think we need a larger frame for this knowledge, one that has been de-emphasized in the last few decades as we've become a fast-forward consumer culture and a pleasure-oriented culture.  I used the phrase earlier, but I think we should recognize that whatever we do we should go deeper into the heart of life, not deal with our lives more superficially and more purely scientifically.  Does that clarify that at all?  I don't know.  Maybe it's a matter of emphasis, and everything you say about this you can say it in a way that sounds disproportionate, even though in your heart you have, I think, a more integrated understanding.  But how would you deal with it, Gil?  I mean, there's really useful knowledge here.

DR. McHUGH:   Well, I just think that this is new era that's emerging.  It's a wonderful new era for people such as myself who are interested in the preventive medicine and the care of chronic conditions.  It's perfectly true that in the new era there are going to be awkward issues that we're going to have to resolve and think about, some of which we can predict and some of which we can't predict.  Just take, for example, the issue that Nancy Wexler, who's an absolutely brilliant and wonderful person who has illuminated for me this issue of Huntington's disease.  She raises the point that people shouldn't be identified without their consent.  And that certainly makes sense to me. 

On the other hand, I'm also interested in the kinds of things that begin at conception and turn up later in life like Huntington's or Alzheimer's disease and things of that sort, and I certainly think that the future is going to be finding the epigenetic methods for pushing the onset of those conditions further and further away.  Unless we begin to recognize the infants early who have this, we're going to lose that opportunity.

On the other hand, I perfectly well know that we'll identify people with the Huntington's gene as infants, and that will illuminate for the parents that they've got the Huntington's disease, and they won't like that.  That will be an awkward moment for them, knowing that they have a condition which in a very few years is going to debilitate them. 

All I'm saying is I very much appreciate this contribution from our staff because I think it was wonderfully balanced in relationship to what the future may hold.  The future is going to be vexed.  Surprise, surprise.   And in that vexation, good things will come and awkward things will come.

But medicine is in a new era now.  You just have to live with the chronically ill to know that this is what we're going to have to deal with, and this seems a step in the direction of doing that.  And what Freud said about—this is what led the Icelandic people to say, "Look, we're going to do this.  It's going to be awkward, but the good and the bad we will work out."  That's what I think.

CHAIRMAN PELLEGRINO:   Thank you, Paul.  Other comments?  Rebecca.

PROFESSOR DRESSER:   A couple of more down-to-earth issues.  So as you point out, the newborn screening is state by state, and some states allow the parents to opt out, and some don't.  And so I think one issue, possibly a recommendation for us would be to address whether as this becomes more of a research tool there is more reason to allow the parents to decide yes or no. 

Now, certainly parents can enter their children into research, and if it's minimal risk, it's pretty standard, pretty—I mean, it's easy to justify.  Is this minimal risk?  Maybe it is if we get rid of the insurance discrimination, job discrimination.  There's still the stigma issues . 

But, anyway, so do parents need more authority over this, and then do they need information about it before they make their decision?  And how is this to be implemented when somebody just has had a baby?  It's not exactly a time where people are feeling like they want to sit down and read for a few hours.  So how do you implement it? 

And I agree that many people in this culture would be interested in including this information for research purposes, but I do think we have to acknowledge that US society is different from Iceland, and they have this whole interesting history of knowing about their ancestors and their family history and so forth.  Plus, it's a very homogenous society. 

And here there are a sizable number of people who don't want the government to have their information for whatever reason or have religious views.  And so what do we need to do to respect the diversity of views among parents about especially the research issues?

CHAIRMAN PELLEGRINO:   Thank you, Dr. Dresser.  Other comments?  Dr. Schulman, Dr. Crowe, would you like to add a footnote?  Oh, I'm sorry.  I missed Dr. Meilaender.  Forgive me.

PROF. MEILAENDER:   No, I was just going to say—because I so wanted to come back to Janet's question.  I mean, I don't know where this stands exactly in the pecking order of possible things, but the one thing that I at least am not clear on—and maybe everybody else is—but it seems to me we want to be clear on before we try to draft something is audience. 

In other words, are we seeking to make recommendations to kind of professionals in the field about the movement that's been taking place in this area?  Are we trying to inform the general public to help them just think more deeply about this?  Exactly to whom would whatever we wrote be addressed?  I'm not real clear on that, and I think it would make a difference just partly in tone but partly even in just what the structure of the thing looked like. 

And I don't know if—maybe we're not far enough along, but I'm still puzzled about that, and I think a little clarity on it would be a good thing.

CHAIRMAN PELLEGRINO:   In keeping with our general orientation, at least in recent meetings, our task is to try to outline the ethical dimensions without having to take positions on all of the very complicated scientific, technical questions; what are the ethical questions one should address; questions of public moment; and to lay the basis for a further discussion by policy makers and so on.

It's certainly obvious that this movement is progressing rapidly, accelerating, and with many of the caveats that have been put forward which I think have great substance to them.  Nonetheless, we might have a responsibility to lay out these issues in some kind of an objective way.  At least, that's the way I'm perceiving it.  I may have misread the charge of the Council, but I think that's our task, rather than coming up with a resolution of all of these very, very complicated issues.

DR. ROWLEY:   You know, pursuant to that, we had a number of discussions on the issues surrounding organ transplantation.  And as far as I can see, we haven't moved much beyond discussion.  So we also over years have had discussions on newborn screening and are having yet another one.  One has to ask the question, if we are really laying out the issues or the ethical issues that should be considered as an area moves forward, is there going to be closure of a sort on some of these issues?

CHAIRMAN PELLEGRINO:   That I don't believe I could answer at this moment.  It seems to me that if there is sufficient—I won't use the word "consensus."  It's misused all the time—but a consistent preponderance of evidence that we ought to go in one direction, a report would reflect that, providing the opportunity, as the Council always has, for those who wish to go another direction. 

So, again, the notion of laying out, as possibly we can, the major issues, with the way they may be presented one way or the other for others to look at, for policy makers.  We don't make policy, as we all know, thankfully in some ways.  And I think that is our issue. 

So, yes, to answer your question, I think you would look at both sides, but we would not make the final determination.  Our aim is at the general public, of course, rather than the scientific community where we can't enter into those technicalities but can look at the ethical issues. 

So I keep emphasizing the ethical issues.  That applies, Janet, as well, to our discussion of yesterday in looking at this complex question of the variety of resolutions of what appears to be a problem for many Americans, the healthcare issue.  I don't think we want to focus on one proposal versus another but, rather, looking at all of them:  Do we have an ethical obligation, for example, who has the obligation, what is the depth of it, and what are the caveats we would put forth from an ethical point of view. 

I think that's the sort of tenor of most of the reports we've put out, and I would see if we do one on this, the same kind of perspective, to answer your question.

I know Dr. Gazzaniga wants to speak, and we can get some expert testimony rather than my general expatiation on what we should be doing or not doing.  Mike?

DR. GAZZANIGA:   Well, I just wanted to underline the importance of the mental state that results from information.  I have to confess that I was a member of the much fabled Animal House and of the many outrageous things that we did.  The person who was the most outrageous thought he was going blind at the age of 30, and he's now a preacher and sees just fine.  But it certainly had an effect on his behavior. 

And new studies are out on the question of what is the manifestation of your belief in whether you believe in free will or you don't.  A very clever psychologist has two groups of students.  One group reads a passage from Francis Crick's astonishing hypothesis, which is very deterministic in nature, and certainly, genetic screening has a very deterministic feel to it.  And another group reads some uplifting paragraph about freedom of choice and so forth.  And then these two groups have equal access to playing a game, and the game allows you to cheat.  So guess who cheats?  The people who have read the deterministic passage just cheat their pants off, and the other ones do not. 

So the mental state that we're talking about, the knowledge of something, has an important consequence, and I just think we should be aware of it and consider it in depth because there's no stopping this thing.  Knowledge will go forward, and it's important, and for all the reasons I already stated and with respect to preventative medicine and other issues. 

But it would be a mistake, I think, not to realize there's a cost.  You know, there's a story—and I'll finish with this—that the Japanese always kept their—correct me if I'm wrong in this, but the Japanese always kept their medical records at the end of the bed in German.  And the reason German was the language of the medics was so that the family couldn't read what's going on with a patient because they were protecting them from the knowledge. 

So it's an old idea, but it's there.  It's real, and it's something to keep an eye on as we inevitably go forward with this technology for probably the greater good.

CHAIRMAN PELLEGRINO:   Other further comments?  We're coming to the end of the term allotted to this particular section of the program.  Yes, Bill?

DR. HURLBUT:   Just a small comment on the question of how we might approach a report on this.  It looks like there's a very good possibility that the Genetic Nondiscrimination Act will go forward eventually, and this might be a really unique opportunity to add something that complements that. 

I think we could use the subject of newborn screening as a moment for speaking more broadly to the whole other side of testing in general and speak about some of the personal dimensions of this and also, by the way, some of the commercial dimensions because there's different kinds of discrimination.  I mean, when you do the equivalent of seductive advertising, especially when there's fear involved, and draw people into testing that is largely inconclusive or useless or even misleading, there's something really wrong going on there.  And even if the FDA controls some of that, or whatever agency would, there's some things to warn people about.  And so the broad social attitudes, the specifics of the relationship within commercial society, and the personal dimensions of this I think are very worth commenting on.  We could use this subject as the platform for expanding.  We did some of this in the perfect children dimension of the "Beyond Therapy" report. 

But there's more to be said, and I think we could make a general document that would be of use to the broader public dialogue, not obviously aimed only at professionals.

CHAIRMAN PELLEGRINO:   I think this would be perfectly consistent with the point of view I expressed in my reaction to Dr. Rowley, no limitations on what would be included, but laying out, again, this idea of looking at both sides of the issue so that we could generate a genuine dialectic or exchange of ideas, which means understanding the other points of view.  And so I think your point is well taken. 

I think we have reached that point when the program calls for us to move on to something else, but before we do that, I want to ask our two staff members if they have a brief comment or question that you want to make on the discussion that might be of help to you in whatever next steps we take.

DR. SCHULMAN:   I'd like to raise a question to the members of the Council.  Among all of the very complex issues raised in this area, it seemed to me fortunate that one of them has been brought into focus recently by the debate that I summarized between Duane Alexander and Nicholas Wald, namely, this specific issue of whether the old principle, "screen only if you can intervene," is a sound principle or a dogma that ought to be discarded. 

It seems to me that one could pluck that question out of the whole range of these things and present a very interesting dialectical discussion of the pros and cons on both sides, possibly including a vote by members of the Council with personal statements explaining the subtleties of their take on the question.  But it seemed to me that it was fortunate that that discussion has taken place recently and it gives us an opportunity.

CHAIRMAN PELLEGRINO:   Thank you, Adam.  I think we will now have a break until 9:45 when we reconvene to discuss the latest report of the Council on human dignity.

  - The President's Council on Bioethics -  
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