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This staff working paper was discussed at the Council's January 2004 meeting. It was prepared by staff solely to aid discussion, and does not represent the official views of the Council or of the United States Government.


Staff Working Paper

The Council's Second Term: Agenda Options

The final meeting of the Council's first term provides a good time for Members to assess the group's work to date and to discuss possible future directions for the term ahead. This paper is intended to help the Council begin this discussion.

I. Points of Departure

To help us take stock of our work to date, we begin by reminding ourselves of the unusually broad charge given to the Council in the Executive Order that brought the Council into being. This breadth is reflected in the specific functions enumerated as part of the Council's mission "to advise the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology":

1. to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology;

2. to explore specific ethical and policy questions related to these developments;

3. to provide a forum for a national discussion of bioethical issues;

4. to facilitate a greater understanding of bioethical issues; and

5. to explore possibilities for useful international collaboration on bioethical issues.

The Council's broad mandate is also reflected in the illustrative list of subject matters to which we were invited to attend:

In support of its mission, the Council may study ethical issues connected with specific technological activities, such as embryo and stem cell research, assisted reproduction, cloning, uses of knowledge and techniques derived from human genetics or the neurosciences, and end of life issues. The Council may also study broader ethical and social issues not tied to a specific technology, such as questions regarding the protection of human subjects in research, the appropriate uses of biomedical technologies, the moral implications of biomedical technologies, and the consequences of limiting scientific research.

The broad charge and range of possible topics invited the Council to develop and pursue a suitably rich and thorough approach in all of its activities. As the Chairman put it in his opening statement at the Council's first meeting:

To do bioethics properly, I suggest, means beginning not with judging whether deed "x" or "y" is moral or immoral, but with what the Executive Order says is our first task: undertaking fundamental inquiry into the full human and moral significance of developments in biomedical and behavioral science and technology. We must strive to understand the meanings of the intersection of biology and biography, where life as lived experientially encounters the results of life studied scientifically. Even as we tackle specific issues, we must always attend to the deep character of humankind's individual and social bioi [lives] and how they interact with the findings of biology and the technical powers they make possible.

In developing a suitably richer bioethics, the Chairman further identified what he considered would be the Council's most urgent tasks: to provide an adequate ethical lens through which to view the particular developments in their proper scope and depth, and to combine the intellectual search for a "rich bioethics" with practical regard for the difficult decisions faced by policymakers, researchers and doctors, and the public as a whole:

Doing this must involve careful and wisdom-seeking reflection about the various human goods at stake: both those that may be served and those that may be threatened by 21st century biotechnology-and, in either case, going beyond the obvious concerns of safety and efficacy. This sort of analysis must begin by prospectively considering what we wish humanly to defend and advance, rather than by reactively considering merely the potential consequences of this or that particular technological innovation. A rich and proper bioethics will always keep in view the defining and worthy features of human life, features that biotechnology may serve or threaten. Yet, at the same time, responsible public bioethics must not lose sight of its practical duty to shape a responsible public policy, as the demands for policy decisions arise piecemeal and episodically. Bioethical thought must therefore be ready and able to bring the aforementioned general considerations to the specific ethical issues at hand. Maintaining this difficult but all-important balance shall be part of the goal of the Council's thinking.

In the light of these points of departure, we next survey the Council's work during its first term.

II. Major Projects, First Term

The Council has undertaken five major projects during its first term, issuing in four already published book-length reports or products and a fifth close to completion. These projects have spanned the range of possible topics and approaches envisioned by the Council's charge.

The Council's first report, Human Cloning and Human Dignity, addressed a very specific issue of current public and legislative debate: it offered specific legislative recommendations, but it did so in the context of a thoroughgoing analysis that sought to clarify terminology, to articulate competing ethical viewpoints, and to locate the entire analysis in the context of the significance of human procreation, the scientific vocation and the obligations to heal the sick, and the overall relation between science and biotechnology, on the one hand, and ethics and society on the other.

The second report, Beyond Therapy: Biotechnology and the Pursuit of Happiness, with an educational rather than policy-oriented intent, stepped back from immediate and narrower practical issues to "conduct fundamental inquiry into the human and ethical/social significance" of providing biotechnological means for pursuing deep human desires, seeking goods beyond therapy and healing. In dealing with technologies ranging from genetic screening and manipulation to psychotropic drugs, the Council substituted for a more customary mode of technology assessment an approach that focussed more on human ends than on technical means and that considered not only undesired side-effects of the techniques employed but the human significance of attaining the desired ends through powers supplied by these novel means.

In its third report, Monitoring Stem Cell Research, the Council executed the narrower charge, given it by President Bush, to keep track of and to report on recent developments in stem cell research and in the ethical and policy debates surrounding it. Having reviewed and analyzed the relevant literatures, the Council presented its findings in a form that should be accessible to a generally educated reader. The report is intended to shed light on where we are now-ethically, legally, scientifically, and medically-in order that the President, the Congress, and the nation may be better informed as we all consider where we should go in the future.

The Council's fourth volume, Being Human: Readings from the President's Council on Bioethics, is a major educational venture. An anthology of readings grouped around ten enduring human themes, this volume is intended as an adjunct to the existing, more analytical literatures of contemporary bioethics. It may also be seen as a companion volume to Beyond Therapy: if the latter gave rise to many large questions related to what it means to be human, this volume brings together readings that may help us answer these questions, or at least think them through more carefully and thoroughly.

The Council's fifth project, on Biotechnology and Public Policy, is once again resolutely practical. It deals not with this or that biotechnology and this or that piece of public policy, but explores the way our society at present monitors, oversees, and regulates a series of biotechnologies touching the beginnings of human life. The anticipated report (due this spring), though primarily a diagnostic document, is intended as a step on the road that seeks the best institutional arrangements for insuring the most responsible and humanizing uses of new biotechnologies.

In addition to these major projects, the Council has had a number of exploratory sessions on a series of other topics, including the following: man-animal chimeras and the boundary of the human; the patenting of human organisms; the ethics of procuring organs for transplantation; "medicalization"; pediatric psychopharmacology; commerce and the body; "human nature and its future"; the "research imperative" and the relation of science to society; reform of institutional review boards (IRBs); and (even) how best to do bioethics.

A few general observations may be in order. First, the Council has ranged from topics very narrowly practical to topics very broadly philosophical. Second, in the practical realm, it has worked on an issue of specific legislation and on questions of broad regulatory practices. Third, in all that it has done (including the most practical of its activities), it has tried to keep in view the larger questions concerning the diverse and sometimes competing human goods, individual and social. In this respect, all the work of the Council to date has had a decidedly humanistic outlook and tone. Fourth, all of the Council's work has sought to serve the twin functions of providing a forum for a national discussion and facilitating a greater understanding of bioethical issues. Our first two reports have also been commercially re-published, the second one by two trade presses. Fifth, in three of the four substantive reports (Cloning; Stem Cell Research; Biotechnology and Public Policy), the "embryo question" has loomed large, and there is a case to be made that other issues of at least equal moment deserve more of the Council's future attentions. Finally, nearly all of the five major projects (perhaps excluding the anthology) point the way to possible follow-up inquiries and studies, that would carry further some matters that were only partly explored or left incomplete in the Council's completed work so far. Some of these "pointings" will be made explicit in presenting the possible topics for the Council's future work.

III. Future Prospects: Preliminary Questions

As has already been noted, the Council's work over the past two years has shown a great interest in ends as well as in means, in the human as well as the technical. In exploring such diverse topics as cloning, stem cells, sex selection, age-retardation, psychopharmacology, organ transplantation, research ethics, and the current (and possible future) regulation of assisted reproduction, embryo research, and genomics, here and abroad, the Council has recurrently asked such questions as: What are the human implications of our new powers in this area? What human goods are these new powers likely to serve or to threaten? What does it mean to be human in an age of biotechnology? Where are the true boundaries between the human and the nonhuman? Are those boundaries now in need of review, revision, or reinforcement?

This "humanistic" emphasis has won the Council both praise and criticism. An initial question in moving forward, then, is whether the Council is more inclined to agree with those who praise or with those who criticize that emphasis. How high "off the ground" should the Council's work be pitched? How fundamental and how practical should its inquiry be?

Second, there are questions to be addressed regarding how to limit the potentially endless list of possible topics,i and how to decide which topics are worthy of study before the group has actually been able to spend time studying them. Presumably the Council will deal with this challenge as it has done in the past, first identifying topics of plausible interest and then doing "test sessions" with expert guest-presenters and detailed background papers to see for itself which questions prove worthy of continued attention.

Yet preliminary and formal questions like these, while important, are perhaps best addressed not in the abstract, but in the context of specific substantive proposals. Staff has therefore compiled the following, non-exhaustive list of ideas for possible lines of inquiry to help prime the conversational pump. Each idea listed here has been suggested by at least one Member, either privately or during a past Council meeting. Several of these topics overlap with each other. Several of them grow out of, or explicitly continue, subjects considered during the first term, and a good case can be made for deepening and perfecting things already begun. Some of the suggested topics are more ambitious and far-reaching, while others are more circumscribed. Some are new to the terrain of public bioethics, others are rather familiar. The paragraphs that follow are meant to give some rationale or explanation for why a topic might be worthy of Council attention. They are, of course, tentative and provisional.

IV. Some Possible Topics

1. Neuroscience, Neuropsychiatry, and Neuroethics. In the Beyond Therapy report, the Council looked at the ways in which powers growing out of brain science can or might enable us to affect mood, memory, and behavior. Clearly these inquiries barely begin to open the questions arising from advances in neuroscience, an area of inquiry that touches most directly on activities of mind and feeling that are central to our humanity. Not only are there discoveries that do and will increasingly lead to technological interventions having important ethical, social, and legal implications. The scientific findings themselves will very likely raise challenges to those forms of human self-understanding that we have inherited from a pre-scientific age. The "human and ethical significance" of this domain of inquiry is, arguably, the most far-reaching and the most profound. Yet no previous bioethics commission has broached the subject.

The field is, of course, vast. And if we entered it, we would need to choose our focus carefully. Here, in no particular order, are some candidates. What ethical issues are raised by new brain-imaging technologies? By practices of deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS)? By mechanical implants and brain-machine interfacing? How should identifiable biomarkers (genetic, psychometric, and brain imaging) be used to justify activities of prediction, prescription, and preemption? What are the ethical and social implications of new findings and theories of desire, reward, and impulse control-and addiction? How do studies of intention, causation, and consciousness relate to moral motives and actions? Conversely, what are the implications of studies on the "emotional" brain for our understanding of moral judgment and choice? What do the scientific findings and their interpretations imply for freedom, responsibility, and criminal behavior? For public policy?ii

2. Children, Bioethics, and Biotechnology. In our Beyond Therapy report, we began an inquiry into how biotechnology affects or might affect children and the character of childhood. We began with a reflection on the meaning of childhood itself, and then looked at efforts to screen and select genetic endowments at reproduction and efforts to augment native endowments as children grow up. But this inquiry only scratched the surface of understanding the social, familial, and medical realities that shape childhood today, and how these realities might influence the increasing demand for new biotechnical remedies to the problems of anxiety, hyperactivity, and despair in children. Has childhood (and parenthood) changed in ways that make behavior-altering biotechnologies more necessary? Has the incidence of depression, anxiety, and hyperactivity in children increased in response to social and familial changes? Or have our powers of diagnosis increased so that we now recognize these dilemmas and disorders for what they really are, or methods of diagnosis and treatment changed so that we understand and address such behavior patterns in new ways? Has the growing use of behavior-altering biotechnologies changed the trajectory of life for the children who use them-altering not only current behavior but future aspirations? Has it changed our ideas about childhood and child-rearing more generally-including the attitudes of children (and parents) who do not use such drugs but have many friends who do?

Our focus on children in BT was limited both in scope and approach: we focused on the uses of biotechnology in children that go "beyond therapy," and our manner of inquiry was largely philosophic and ethical. In the next two years, we might conduct a much deeper inquiry into biotechnology, bioethics, and children, combining both empirical research into biotechnology and the state of American childhood, and ethical and sociological reflection on what these new realities might mean. While the point of entry might be the rapidly expanding use of psychotropic drugs in children, the inquiry could help to highlight in a manner both intellectually rich and practically useful a major set of issues concerning the well-being of America's children.

3. The Elderly, Biotechnology, and Bioethics. (This topic would seek to do for the elderly what the last proposal would seek to do for children; notice that both of them would adopt an unusual, humanistic approach, beginning not with some technical question, but with a segment of society with special needs, concerns and vulnerabilities.) In our Beyond Therapy report, in the chapter on "Ageless Bodies," we began an inquiry into how biotechnology might in the future affect the processes of senescence, the character of aging, and the health and vitality of the elderly. But we said little if anything about important bioethical issues touching on the well-being and care of the currently elderly and aging population, a growing fraction of American society. Several sub-topics suggest themselves as worthy of attention, and a larger project might seek to combine several of them.

One is dementia (including Alzheimer disease): Our population is aging, and with it the population of persons with dementia. What is the human meaning of this condition? What is the scope of the problem right now, and how might things change in the near future? What is in the best interests of people who suffer from it, and how concretely might this be determined? What research avenues are currently being pursued? Which avenues seem most worthy of support?

A second sub-topic is decisions about life-sustaining treatment, especially for patients unable to make their own choices. In light of the recent Schiavo case (in which a state legislature intervened to prevent a comatose woman's legal guardian from terminating her nutrition and hydration), what normative standards should govern decisions to forgo or continue life support, especially when the patient has no clear terminal prognosis? What standards should govern treatment of incompetent patients? Are advance directives sufficient or effective? How, in a society of aging Baby Boomers, should individuals and society regard medical measures to sustain life in those who are less than fully competent? What is a "good death?" When, if ever, is a life "not worth living"?

A third sub-topic is general care of the elderly. Bioethicists have given much attention to the dramatic termination of treatment or end-of-life decisions, but relatively little attention to the much more prosaic but perhaps even more significant ethical questions concerning the ordinary place of and care for elderly people in our society. To concentrate only on the technological meaning of "life-sustaining treatment" to the neglect of the more social and human meaning is to overlook a matter of growing significance with a progressively aging society and with fewer family members available to attend and care for older people. While not strictly speaking a problem raised by biomedical advance, it is one of the side effects of increased longevity (and other consequences of modern technological society).

4. Biotechnology and Public Policy. The BPP report that we will be issuing in the spring is explicitly an interim report. And although the report will indicate that we do not yet have enough information for making any useful recommendations regarding changes in current institutional regulatory responsibilities, there may be useful activity for the Council to continue in pursuing this question. It might be possible, for example, to develop a set of position papers arguing the relative strengths and weaknesses of the various institutional alternatives (including the alternative of doing nothing new).

5. Organ Transplantation. What is the current state of the art in this field? What are the current success rates and what do they mean? What possible breakthroughs lie on the horizon? Is there an organ "shortage," and if so, why? What are the important differences between U.S. and European transplant policies (and industries)? How should organs be procured and allocated? We hear today increasing calls for using market forces in procuring and allocating organs for transplantation. Should there be some modest financial incentives to increase donation? Should there be overt markets in organs, limited or otherwise? Should the current altruism-based policy be retained? What are the larger philosophical or humanistic questions raised by our having come increasingly to think of the body as a collection of "useful" organs?

6. Property and Commerce in the Body. (This topic overlaps with the previous one.) The Council has spent some time considering the meaning of patenting human organisms, and there has been an effort in Congress to forbid such patents. Some Council members have expressed an interest in the issue of patenting other living forms. What are the ethical and policy implications of permitting people to hold patents on genes, tissues, organs, or gametes? On other living things and their parts? To what extent should the human body and its parts and precursors be objects of commerce? Where should the boundary be drawn, and why?

7. The Boundaries of the Human. What do we really mean when we speak of a "human organism"? What genetic complement, cytoplasmic factors, and dynamic developmental context define such an entity? What is meant by the term "human-animal chimera"? Might current or proposed lines of research blur the boundary between the human and the nonhuman (especially between the human and other primates)? If so, what difference should this make, and why? Are there "natural kinds" that human beings are bound to respect? If so, why?

8. Acceptable Risk. New medical powers raise questions about levels of acceptable risk. For example, if, as some studies indicate, IVF is associated with a doubled rate of serious congenital malformations, should it be judged against standards of risk used in other medical procedures? Or does the chance to "be alive at all" justify a greater-than-normal risk of disability? On the other hand, are parents with certain genetic or chromosomal "problems" acting unethically when they procreate without recourse to ARTs like PGD and sperm sorting? Should PGD (with its attendant risks) be available to people who are neither infertile nor at great risk of producing children having serious genetic disease? How should transplant surgeons whose first responsibility is to "do no harm" take account of such risks when operating on the healthy to help the sick? How should potential donors regard such risks in making the decision whether or not to give their organs? Do such risks make sense between family members, but seem strange in the context of anonymous donation?

9. Health Care Issues and Research Priorities. A number of suggestions have been offered for subjects that might be described as "everyday" or "practical" healthcare issues, including: how to address the problems of the uninsured; how to ensure a more sensible distribution of health resources (as between research, treatment, and prevention); and how to better combat preventable diseases abroad, such as malaria and HIV.iii

10. Bioethics Itself. From its first meeting, the Council has expressed an interest in encouraging a "richer" bioethics. This implies a certain criticism of bioethics as currently practiced. Is today's bioethics satisfactory? If not, why not? Are the traditional principles used in bioethical analysis (beneficence, autonomy, justice) satisfactory? If not, why not? The Council in its writings has made use of the notion of "human dignity," and this usage has drawn some criticism. What exactly is meant by "human dignity"? Is this just a slogan, or can it be given manifest and weighty content? What is the relation between nature (and human nature) or the natural and ethics or the ethical? Are there any universal or cross-cultural ethical norms for addressing bioethical issues?

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Footnotes

1. One way to weigh the relative merits of proposed topics might be to "screen out" those that fail to pass certain "tests" or "filters." For example, one might wish to set aside any subject about which any of the following questions would produce a clear "No" answer: (1) Does it involve an ethical question with public-policy implications? (2) Is it worthy of national attention? (3) Is it within the scope of the Council's mandate? (4) Is there no federal agency (or branch) already addressing it, or better situated to do so? (5) Is it ripe (sufficiently mature for consideration now)? Is there some pressing reason to take it up sooner rather than later?

2. The guest presentations at the January 2004 meeting may suggest some topics as most worthy of attention.

3. The question of distribution of research and treatment resources was also raised in the context of the "beyond therapy" uses of biotechnology, a question that almost asks itself when one notices (as we did in Beyond Therapy) that in 2002 Americans spent ten times as much on drugs to treat baldness ($1 billion) as was spent on malaria research, and $7.7 billion on 6.9 million cosmetic procedures (up from 2.1 million in 1997).



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