March 12, 2009
Council Members Present
Edmund Pellegrino, M.D., Chairman
Floyd E. Bloom, M.D.
Scripps Research Institute
Rebecca S. Dresser, J.D.
Washington University School of Law
Nicholas N. Eberstadt, Ph.D.
American Enterprise Institute
P. George, D.Phil., J.D.
(Present via telecom in the afternoon)
William B. Hurlbut, M.D.
Donald W. Landry, Ph.D.
(Present via telecom in the afternoon)
Peter A. Lawler, Ph.D.
Paul McHugh, M.D.
Johns Hopkins Hospital
Gilbert C. Meilaender, Ph.D.
Janet D. Rowley, M.D.
The University of Chicago
Diana J. Schaub, Ph.D.
Carl E. Schneider, J.D.
University of Michigan
NATIONAL ETHICS COMMISSIONS: THE VIEW FROM ABROAD
CHAIRMAN PELLEGRINO: Good morning. Welcome to the Thirty-Sixth Meeting of the President's Council on Bioethics. The first act of every Council meeting is for me to recognize Dr. Daniel Davis to my left who is the Executive Director of the Council and the official government representative. He gives us legal, I suppose, credibility and credibility of other types as well, but particularly that one we have to say.
This morning we will begin the examination of the question we had started at a previous meeting of national ethics committees. This Council has been, most of it, in operation for almost eight years now and we thought it might be useful to examine our experience and to hear more about the experience of other commissions in other countries with the idea in mind perhaps of putting together a report with recommendations or at least an examination of the question.
Our first speaker — and I want to say for this part of the meeting and throughout — we do not provide lengthy introductions simply because we want to give the speaker enough time to cover the subject and to open it up to consideration by the Council, so I will only read the titles. You have those on the agenda.
Our first speaker is Marie-Hélenè Mouneyrat, Secretary
General — and I dare not try to pronounce this, but I will
try and stand to be corrected — Comité Consultatif
National d'Ethique from France. She's been good enough to come across
the waters to speak to us and enlighten us on how the commission
question is addressed and how it operates in France.
SECRETARY GENERAL MOUNEYRAT: Thank you. First of all, I would like to thank you a lot, President Pellegrino and Dan Davis. Thank you for your so kind invitation which is for me both an honor and a real pleasure to be with you.
In recent decades, ethical concerns have become the preferred spiritual nourishment of our contemporary societies, and no longer only in the most advanced of them. They are gradually gaining ground in every sector of human activity.
Cosmetics must be ethical; ready-to-wear garments must be ethical. Foodstuffs must also be ethically acceptable. And the current crisis, which is changing the world as we know it, enhances this concept. The stock exchange itself will have to respond to ethical criteria.
So ethics are in the process of becoming a good investment and, in such a context, the ethics committee concept is very certainly one that is heavy with promise for the future.
In the area of the health and life sciences with which we are concerned today, however, such an institution has distinctive characteristics which are very specific to its field of expertise. New issues are looming in the original bioethics committee as are new challenges which we need to take on.
These issues are predominant in four areas. The first one is the relationship of ethics committees with the world of science; secondly, the relationship of ethics committees with politics; thirdly, the relationship of ethics committees with society; and finally, the relationship of ethics committees on an international scale.
The first ethics committees focused on health and life sciences. And when the President of the French Republic created the French National Consultative Ethics Committee in 1983 — and it was at this time the first in the world — he gave as his motive for doing so that "science moved faster than human society." So the first task for such a committee is therefore to prevail over this apparent antagonism between science and society.
When the French committee started to operate in 1983, the issues
at stake were in the area of advances in medical-assisted reproduction
with the birth of the first test-tube baby, which was the source
of both fascination and unease. In those early days, the difficult
problems confronting us already included the status of embryos,
the discovery of the genome, and tests involving human beings, and
another burning issue which at that time was looming large because
of the connection with surrogate motherhood — that is using
the human body for commercial purposes.
So the composition of ethics committees, which naturally includes scientists but also legal experts, philosophers, anthropologists, journalists, representatives of associations, et cetera, is a good reflection of the care taken to establish a bridge between scientific research and society.
A few words about the situation in France. In France, the committee's
membership is defined by law. We have five personalities belonging
to the main philosophical and spiritual currents. And presently
we have a Catholic, a Protestant, a Jewish, a Muslim, and a laic
[secular] person; then nineteen personalities chosen for their competence
and interest in ethical issues; and finally, fifteen personalities
from the research sector. These thirty-nine members are appointed
for four years, renewable once.
The Committee's work is directed by its president, who is appointed by the French President, who is appointed by the President of the French Republic for a renewable two-years mandate. In this respect, bioethical reflection could be defined as an exploration, with all due modesty, of the relationship between scientific progress and social acceptability.
Now, this mission of the ethics committees, which goes further than just constructing a bridge between two areas of human endeavor and dispelling public misunderstanding of scientific progress is, I think, a primary and fundamental issue. To accomplish it, ethics committees must take up a certain number of challenges.
The first of these is linked to the intrinsically fluctuating character of scientific progress, which means that we must accept the precarious nature of ethical reflection. Nothing can ever be set for eternity, and the pronouncements of ethics committees must always be open to revision in the light of new scientific developments.
For instance, as regards medically assisted reproduction, it's
clear that, if and when oocytes can be frozen without damage, the
issues of what to do with superfluous embryos and about the embryo
research, in general, would be placed in a very different light.
As regards the way in which reflection is conducted, there are
some essential requirements. Ethical reflection must never be dogmatic.
When the French committee was created at the beginning, its members
wondered how they should go about constructing their opinions.
Two methods of work were open to them: either choose to start thinking
in abstract terms in the hope of arriving at elemental principles,
on which agreement can be found and which can be used as a guide
for every subject to be considered; or else use the issues raised
as the starting point in order to see whether the completed opinions
could also yield commonly acceptable, fundamental principles.
The second of these methods was selected, and that was precisely
due to the very singular nature of bioethical reflection. It so
happens that this evolutionary mode of operation has, in France,
remained central to reflection on the appropriateness of passing
from ethics to law with, as an inevitable consequence, the establishment
of connections between ethics and politics. This is a second point
at issue for ethics committees.
In France, legislating on bioethics was not an immediately obvious
way to proceed. Discussion on the subject in France was extremely
sharp, in particular because it did not seem possible to immobilize
scientific progress within what would seem at first sight to be
necessarily rigid normative boundaries. Scientists were apprehensive
and reluctant to accept such changes.
And French lawmakers launched a kind of legal revolution when they introduced the concept of a revisable law, choosing five years as the lapse of time before it would be reviewed and the implementation of its decisions assessed.
The societal choice is no longer much disputed, except that currently
in France we are organizing the Estates General on Bioethics, which
is a discussion to prepare a reexamination of the 2004 laws on bioethics,
and this discussion also includes the question of whether it would
be appropriate for the text of the law itself to set a time lapse.
In any event, the major consequence for ethics committees is that ethics and politics are no longer two separate domains. Relations between the ethics committee and the parliament, as well as between the ethics committee and government are inevitable. So the French National Ethics Committee is regularly consulted and associated with the work of the Parliamentary Bureau on Scientific and Technological Evaluation.
On the other side, the government — as we've seen very recently, the Prime Minister in the context of the Estates General on Bioethics — the government also frequently refers to the committee on the subject of draft laws submitted to Parliament for discussion.
As a result, the challenge to be met by ethics committees is to carry out this consultative mission in an advisory capacity while retaining their independence. This is a fundamental concern because I think that independence guarantees the credibility of the ethics committees.
So for that, French legislators provided CCNE, the French committee,
with a number of essential safeguards for its independence. The
first one is that the 2004 law gives to the French committee the
status of independent authority, with a budget appropriation run
by the prime minister, but with exemption from financial audit and
only a posteriori accountability to the Cour des Comptes,
which is the French supreme audit authority.
The second guarantee of independence, the CCNE's membership, as
I said, is stipulated by law so that it is preserved from any arbitrary
decision on the part of the executive, were it tempted to take control
of the committee. The 2004 law also gives the French committee power
of self-referral which is another fundamental safeguard of its independence.
However, prudence is still advisable since we have seen, for example,
that a considerable delay on the part of the authorities in the
membership renewal procedures could, de facto, paralyze the Committee
and be viewed as an insidious attack on its independence. Finally,
the Committee's latitude in the publication of its opinions on subjects
of general interest through the medium of press conferences is certainly
the major expression of its independence, insofar as this makes
the Committee the principal actor of ethical reflection for the
benefit of citizens.
I think that ethics committees must be the preferred instrument for the establishment of an unfettered and reasoned debate on bioethical issues by society, firstly, because the existence of this societal debate is an essential condition for society's willingness to accept normative rules. Moreover, this is one of the essentials of participative democracy. In this respect, the particularly sensitive role of an ethics committee in such a democracy on the borderline between representative and direct democracy becomes very clear.
And we have present in front an illustration of this in the context of the current Estates General on Bioethics. The French National Ethics Committee has a complex mission, together with other structures, to organize citizens' debate into a lot of conferences, so that when the time comes for legislators to review the laws, they can take account of society's aspirations.
But while this task of the ethics committees is therefore absolutely essential, it is also particularly delicate. And the difficulties arise both out of the subject itself and the nature of bioethical reflection. The subject is particularly complex and almost always requires a degree of scientific knowledge which all of our citizens do not necessarily possess. In subjects such as, for instance, genetics, nanosciences, environmental health and biodiversity, scientific expertise must be at a high level.
Secondly, the nature of bioethic reflection is another difficulty. As you know, bioethics is not an exact science which is why teaching bioethics raises so many issues. There is no such thing as "bioethical truth." Ethics are a search for enlightenment. And obviously incorporating a complex process of questioning into an already complex domain is far from easy.
In this connection, there is the matter of the way in which ethics committees work and express themselves. Should we do our utmost to arrive at a consensus or simply set out the arguments for divergent standpoints?
Quite clearly, a consensus will be difficult to come by in a pluralist and multidisciplinary assembly discussing sometimes extremely sensitive subjects. And the danger here is arriving at what can be described as a "soft" consensus. It may, of course, seem surprising that a gathering of forty people in France, whose convictions are so very different, can arrive at any form of common position.
But, in fact, there is never any need to erode anyone's sharper angles. The process consists more in revealing the strongly held point of reference at the core of each belief which surprisingly emerge as shared by all when human dignity is involved, and when there is no call for being answerable to some electorate or to the issuers of voting instructions.
I would say that in the French committee, all the members are present
"intuit personae," but they are not strictly speaking
representatives. It's only when there is freedom of speech for all
that everyone can be heard.
But it happens that there is no way of arriving at a point of concurrence acceptable to everyone. Some members on such sensitive issues, for instance, the status of embryos, may be reluctant to commit themselves to an opinion. In that event, they are at liberty to set out their points of difference in a dissident opinion, which is published at the end of the Committee's opinion.
Another complicating factor for the social debate is that, of necessity, the media must be the vector for raising awareness in society. I could say, perhaps, that there is a fundamental opposition between ethical reflection and the needs of the media. The media — I don't know if it's especially in France — but I feel that the media inference revel in the sensational and stark black and white choices: that's yes or no, good or bad, true or false, et cetera.
And, clearly, bioethics issues and the opinions in the Committee cannot conform to such a pattern so that their mediatization — which is so essential to raising the awareness of society — their mediatization turn out to be extraordinarily difficult, unless a reductive presentation is considered acceptable.
CCNE French Committee has made and continues to make a very special
effort aimed at the younger generations. Every year at its annual
conference, youngsters are asked to participate. High school students
are invited to present the fruit of their deliberations after working
on various themes with their teaches in a para-disciplinary plenary
approach. Their thoughts may bear on subjects as varied as organ
transplantation, anonymity for gamete donors, euthanasia, end of
life, et cetera. And after each of their presentations, there is
a debate with the CCNE members and the public. And our committee
attaches the greatest importance to these discussions with high
school students as they are very close to an ideal of ethical reflection,
which does not consist in the instillation of elitist knowledge,
but more in "questioning the consequences of the decisions
we take that will change the lives of those who survive us."
[P. Le Coz]
For the younger members of our society to claim ownership of such
problems shows a readiness to anticipate ethical issue rather than
allow them to intrude on us and then try to deal with them a
posteriori. In this respect, ethical reflection is a preferential
path to exercising the responsibilities of citizenship. It's for
this very reason that the philosopher, Hans Jonas, placed a concern
for younger generations at the very foundation of ethics.
The fourth point I would like to raise is the issue for an ethics committee to give its reflections in an international dimension. For quite a long time, ethical reflection was confined within national borders with, as a result, a restrictive and reductive view of the issues at stake because of the single-culture approach.
In modern times, such an approach has become unacceptable. First
of all, very obviously, scientific research knows nothing of frontiers,
while discussion and collaboration between transnational teams is
ever more frequent.
Another reason is that there has been a proliferation of ethical
committees or similar structures in many countries the world over.
In earlier times, they were restricted to developed countries, but
increasingly their creation is spreading to developing countries.
In this connection, you perhaps know that in the context of the
follow-up to UNESCO's Universal Declaration, a program of support,
which is called the ABC Project, which means Assisting Bioethics
Committees, has been set up to help countries establish ethics committees
where there are none.
This program, in which I am honored to participate, is aimed particularly
at African countries. It is obviously essential when research protocols
involve countries in both the north and the south, for them to be
able to consult an ethical institution in each of the countries.
Finally — and, of course, this is a statement of the obvious, we live in a global village and borders are increasingly open. It would be totally counterproductive to ignore this essential dimension which must be conducive to a multicultural development of ethical reflection.
But opening bioethical reflection to international scrutiny has raised and continues to raise an essential query which is related to the duality between ethical universality and cultural diversity. The question is, are there universal ethical principles which can be acceptable and recognized by everyone?
The discussion is ongoing, but we must be cautious. There was a time, I believe, when the dangers of setting up cultural relativity as an absolute value were underestimated and as a consequence it may have become an alibi for alignment with the lowest ethical bidders.
There is indeed a challenge here arising from the internationalization
of procedures. And we see today in France in the context of the
reexamination of the bioethics laws, we can see how practices prevailing
in one or other European countries [can serve as] an encouragement
to "shop" for the most favorable rules. This can be used
as an argument by those who consider there is no alternative but
to align with the lowest ethical bidder.
In conclusion, first, I would like to insist on one of the main challenges for the future which consists in taking into account the person in its environment, and this challenge obviously raises the question of the relations between person, progress of science, and protection of biodiversity. I think it's a main concern for the ethical committees.
Finally, just a word about one final challenge that ethics committees will have to face up to. Is it a challenge or perhaps also an opportunity? I don't know. But I refer to the institutionalization of such committees. As I said, there are an increasing number of them worldwide. Some are relative newcomers, and others are seen as venerable institutions.
This opportunity also represents a danger. The danger is letting the consultative role slip away. In other words, losing their soul and paving the way for a society deprived of its capacity for reflection, having handed over to a club of professionals, not to say ethicists, but having the right to say what is right or wrong.
Such a society would be anything but democratic. Ethics committees can only be meaningful in that they bring enlightened meaning to social debate. Their essential role, nationally or internationally, is to spark debate. In this way, they preserve the necessary awareness of uncertainty, this essential component of our humanity. Thank you.
CHAIRMAN PELLEGRINO: Thank you very much, Madame Mouneyrat, for a most enlightening discussion of an issue and opening with such a wonderful summary of the issues.
Our next speaker will be Hugh Whittall, Director of the Nuffield Council on Bioethics in the United Kingdom.
MR. WHITTALL: Thank you. I do have to say it is
a real pleasure and a privilege to be invited and to have the opportunity
to speak to this Council, which I know my colleagues greatly admire.
And it's a pleasure also to follow immediately after Marie-Hélenè,
who I also know well, as we all are part of a mutual appreciation
society. But for me, it's also unusual in a sense to just speak
in this kind of environment as I prefer to see myself as one of
the backroom staff. But, hopefully, I can just give you a little
flavor of the way things work in the UK.
It was really interesting, actually, listening to Marie-Hélenè,
because she and I, I think, have taken a rather different approach
to this, as you will see in a moment. But what was really interesting
as I was listening was how many points we will touch on the same
kind of questions even though we are coming at it from a different
So the Nuffield Council on Bioethics is quite a unique body in many ways. It does resemble national bioethics commissions in some countries in some respects, but there are clearly some differences. And I think one of the questions we may ask is, what kind of differences are there? Why do they arise? And what kind of implications do they have?
That's not to say that in the UK the question has not been raised
as to whether there should be a national commission, a statutory
commission indeed. And it was only just over a year ago that Baroness
Royall, who is the Minister of State for Health in the House of
Lords, she said during a debate on amendments to the human fertilization
and embryology legislation that the Nuffield Council on Bioethics,
along with a number of other committees, have the appropriate expertise
and sufficient time to devote to complex issues within their field.
This distributed system of bioethical advice works well. It remains
our view — that's the view of government — that a national
human bioethics commission would not bring sufficient benefits in
Of course, I think there's a very long history behind this. And what I would like to do is to give you a little of that history, say, a little bit about the role as we see it, the role and the operation of the Nuffield Council on Bioethics, but also touch on some of the principles that it employs in considering issues, and its approach to these questions of consensus and public opinion. Again, that's something you've just heard something about.
So it was in 1991 that the Council was first established. It arose essentially because of concerns being expressed within the scientific community itself that there needed to be some greater ethical and social reflection on developments that were happening in basic science and medical sciences.
The government at the time was not terribly interested in setting up a commission itself, and it said so, although, the prime minister of the day, John Major, did welcome the establishment of the Nuffield Council at the time and even suggested that it's realm may be wide enough to extend to issues around, for example, food and agriculture and genetically-modified organisms. So it's not that there was no interest from government, but rather they did not see at that time and still don't see the need for it to be a statutory or a government body.
So in 1991 the Nuffield Foundation established the Council, and in 1994 the Wellcome Trust and the Medical Research Council joined it as the three funders, and that remains the case now.
Of course, the situation has changed really quite significantly since then, some fifteen, almost twenty years on. It's no longer the case that the Council is alone in looking at questions in this field, and in fact, we've got quite a complex network of advisory bodies. And the Minister, in the quote that I just gave you, touched on some of this.
But the perceived need for independent advice remains, but this
is some of what we have in the field. We have government advisory
bodies set up specifically to deal with a number of questions such
as human genetics, gene therapy, and of course, animal procedures.
Ad hoc advisory committees are established from time to time. There
was one a few years ago, a House of Lords Committee, for example,
on euthanasia and end-of-life issues. We have statutory regulatory
authorities, a part of whose task is to give advice on the areas
that relate to them, in particular, the HFEA [Human Fertisation
and Embryology Authority] on the Human Tissue Authority.
The Nuffield Council is not the only independent body. The British Medical Association's Medical Ethics Committee is quite influential. And other academic bodies — for example, the Royal Society, the British Association, and the Academy of Medical Sciences — all play a role in this field as well and are really quite committed to engaging in a way that reflects on social and ethical issues that bear upon their areas of science and medicine.
So there's a lot of people in the field. There are good relationships between these bodies. There's no formal coordination. We take care not to tread on each other's toes, not to duplicate work unnecessarily. So there's an understanding of how this works. And I'll come back to this.
The Nuffield Council itself, I've mentioned its funding. The chair is appointed by the three funders. The chair is in post for five years. It's currently Albert Wheel, who is a Professor of Government at Essex University.
The Council itself, once established, then went on to select its own members. So we have a rolling process of recruitment of members selected by the Council itself. Members are appointed for an initial three-year term with the possibility of a second three-year term. So ordinarily they would be there for six years. They will come from disciplines including basic sciences, medical sciences, law, sociology, anthropology, philosophy and ethics, public health. We have a membership of around seventeen or eighteen.
It's important to say that the members are not there to represent their professional interests or any other sector or interest. In fact, they're instructed that they are not there to represent those interests. They are there for their expertise, their engagement, their willingness to participate and to share their expertise in this process of reflection. It's an important point that — again, I'll return to this — it is not a representative role.
The constitutional position of the Council is quite clear. It simply has no constitutional locus. In a sense, this means that it has no leverage, no essential leverage, but this is not necessarily a disadvantage. And again we'll touch on this again later. The source of its authority, therefore, is not about its position, its official or formal status, but rather about its ability to deliver work that demonstrates high quality and independence. And they are the two principles that its work is founded on, quality and independence.
The terms of reference, this in a sense seems rather too straightforward and obvious. But I think it's just actually quite important to pause and reflect on these three key points about the terms of reference of the Council.
The first is that it should identify and define and anticipate
advances in biological and medical research that give rise to, or
may give rise to, public concern. It is this question of anticipation
that is an essential thing that the Council is very mindful of.
The second is that it should report on such questions with a view
to promoting public understanding and discussion. So this is the
second distinct role, to promote public discussion and reflection.
And the third distinct role is to make reports and recommendations
as they may judge appropriate.
And I think, again, it's important to note that being in the position it is, its recommendations can be directed, can be put in any direction. It's not simply to government. Recommendations could entail issues of law, changes in legislation, of regulation, of professional codes, or of day-to-day relations within medical practice or elsewhere. And indeed recommendations can be and are regularly made, not only to government, but to industry, to professional bodies, to non-governmental organizations. So the Council is not limited in the directions to which it will look when it makes its reports and recommendations.
In practice, the way that the Council operates, is to appoint expert working parties to work on each particular project. Typically, a working party will consist of between eight and twelve experts from various disciplines within which fields touch on the issue in question. And typically, the working party will include two or three members of the Council itself. And the Chair of the working party, who will be appointed from outside, will sit as a member of the Council for the duration of the working party.
I think there's a tactical element to this. The Chair of the working party, being also a member of the Council, when they bring the draft report, their reflections, to the Council, has a commitment to the Council as a member himself. But also as there are at least two or three members of the Council who are on the working party, it gives a tie-in between the working party and the Council. And, again, I'll come back to this.
This relationship between the working parties and the Council is
an important way in which work develops and emerges. There is what
our current Chairman calls a "dialectical struggle" between
the two bodies whereby intellectual issues are thrashed out, and
there is, in a sense, a critiquing of work that is honest, it's
open, it's engaged, and it produces through its dialectical process
eventually. And I'll come back again to this at the consensus that
we tend to find.
So a working party is constructed in this way. It goes through a process of what we call fact-finding and public consultation, which is again a very important part of the work. It represents a genuinely open inquiry. Everyone who wishes to speak on an issue will be heard. Whether views are taken from experts or from the public, there is no sense in which the Council or the working party feels it has to be led by that. And certainly, insofar as public views are solicited and a notion of the public view may be elicited, the Council certainly does not feel compelled to reflect or relate that or certainly not to follow it.
Not having a constitutional role, the Council does not have a democratic mandate in that sense. So there's no compulsion on it to follow public opinion. But it does listen. It does reflect. It tests those opinions just as it would any expert opinion as well. Insofar as opinions from the public appear simply as intuitions, they will be examined to try and understand what kind of underlying assumptions are involved there. And so those can be tested. They can be tested against evidence and against the particular expert views that are being presented as well.
The peer-review process that we use is also a significant contributor to the developmental work. We seek the views of eight or ten peer reviews, not at the end of a report, but it's probably during its process of development when ideas are forming. We invite expert peer reviewers to comment on the cohesiveness, the comprehensiveness of the draft report, on the cohesion of the principles, on the argumentation and on its logic. So we are really inviting them to engage with it, and they make a difference. The working party will respond. We would expect draft reports to be improved by the peer-review process. So, again, this is a process of engagement where everybody is in a position to contribute through this process of reflection and argumentation.
Reports clearly are published. This is a difficult part because they have potentially very different audiences. We tend to produce really quite lengthy reports showing the examination of the issue and making fairly detailed recommendations. These must be directed to policy makers. One of the principle outcomes must be policy focus. But at the same time, they have to have a good degree of academic credibility. At the same time, we want them to be understandable to a much wider public and to parliamentarians who like to only read one piece of paper rather than a large document.
So finding these different audiences is certainly very difficult. More recently, what we have tended to do is to produce different versions from everything, from 100 pages to two pages for different audiences. I don't think we've come to the end of this process, and I don't think we ever will find the solution to addressing so many different audiences with one single piece of work.
But what is important is that we don't see them as worthy reports that are destined for library shelves. They have to be — in fact, they are — this is just an illustration of some of the reports that we've produced over probably the last ten years. Some of these are still discussed. They are still used. They are still referenced.
We can't afford to print them all anymore in the numbers that they're needed. But the number of downloads runs into thousands per year and in some cases of these — health care research in developing countries, the use of animals in research — tens of thousands every year. So they still remain relevant and they're still used, and some of the debates are returning especially genetically-modifying crops.
So in going through this process, some of the key issues — and this is where we'll return to these questions about principles and consensus — we'll just talk through some of these, what I think are some of the key issues of what supports the way that the Council works.
The first is how important it is that the Council is in a position to choose its own topics for examination. The Council is funded by three funders: the Nuffield Foundation, the Wellcome Trust, and the Medical Research Council. We invite them, as we invite many others, to identify issues that may be worthy of examination. We talk to many people about what may be on the agenda. We hold seminars and workshops where we invite people to reflect on issues that are problematic at the time. But the Council itself chooses the topics. There is no attempt to influence that by the funders, and the Council would resist it if there were.
The criteria, the basis on which it chooses the topic, is that they should be timely. We're looking for things that are on the horizon so that when we report they will be very timely. There's some novelty to them, there is some complexity to them clearly, and the Council is in a position to make a unique contribution.
There have been topics where the Council has chosen not to proceed, for example, fairly recently on the question of the allocation of resources in health care, not because it's not an interesting question — it's a fascinating and important question — but it's one that many people have thrashed around at for many, many years, and there's no particular reason to think that the Council could provide a distinct contribution in that particular area. So it looks for something where it can provide a novel and unique contribution.
The further question then is, in considering any question, what principles does it employ? Again, we talked already this morning about pluralism, and there is a recognition in the Council of the importance of pluralism that many people take different views. And there is no a priori reason to suppose that one should be favored over another in all circumstances.
Maybe the easiest thing would be to refer you to this. We commissioned a report a year or two ago that was prepared by John Harris, who is a notable philosopher and ethicist. He and a colleague of his did some work for us in trying to identify what the Council had done in the past and what it said about how the Council approached this question. His report is on our website.
It's a very serious, thoughtful report. And there are a number of issues that could be seem repeatedly through the Council's reports such as prevention of harm, beneficence, respect for persons and autonomy, justice, informed consent, confidentiality and privacy. And what he noted — well, they noted. He and his colleague, Sarah John, noted — was that over the course of the Council's works they increasingly developed clear and transparent ethical frameworks on which the reports were based.
So whereas in the early works, the Council's reports would tend to simply lay open an issue and then set out its conclusions and recommendations, increasingly in the latter reports they have identified the ethical principles on which they are constructing their arguments, they lay those down as an ethical framework, and then the conclusions are sign-posted and clearly referenced to that particular framework.
So if we look at the recent reports on the public health, which
took a kind of J. S. Mill liberal state as a starting point, developed
it by looking at how that could be updated to a current contemporary
liberal society introducing values of, for example, protection of
the vulnerable and of reducing unfair inequalities, it constructed
a notion of the state on which it could then found its approach
to issues in public health.
So this basically became more and more explicit, but it is not a single approach that is taken in all cases nor should it be. There is not one single universally applicable framework that can be distinguished throughout the Council's work. And in fact, as Harris has put it, there is a need for policy advisory bodies to retain greater flexibility to incorporate new or different elements in response to the changing social and technological environment. And, indeed, as we consider different cases from animal welfare through to genetically-modified crops, it's difficult to imagine a single set of principles or approach that could apply in all cases equally.
So the further question here is about consensus. It's been quite interesting to note that the Council has achieved consensus in all of its reports. There's not a policy document. There's not a founding document of the Council that said that this is what it must do or this is what working parties must seek to achieve.
So in a sense, I'm just kind of trying to read into how things happen that helps to produce this. And I would just point out three things, I think. They're not alone. There may be other factors, and how they weigh in is difficult to measure.
But first is the fact that individual Council members and individual working party members don't come with an affiliation. Of course, they belong to professional groups. Of course, they belong to professional societies. Of course, they have certain philosophical and ethical views. But they don't arrive being representatives and having to associate themselves directly with these. This is important. And they sign up to that when they join in with the process of within the Council's work.
The second point is, in a sense precisely that, the willingness to engage in these issues, to approach them with an intellectual honesty which says that we will look at all questions, we will challenge them all, we will work them all through, and we are willing to sign up to something which says, "This is a good approach that is workable."
I don't think that anybody imagines that what we are trying to do is to find the definitive and final word on any question. That isn't to say that the result is unsatisfactory. But, nevertheless, I think there is a willingness to be a participant in something that hasn't yet finished.
And the further point is this one I referred to earlier, which is that the relationship between the working party, which consists of particular experts working on a particular project, and the Council, which has a longer-term overview and which receives reports back from the working parties, receives its draft reports, and has to sign off and sign up to its final report, is this dialectical struggle.
The challenge. It's quite interesting watching, as I have done over the last year or two, the chairs of new working parties come to their first Council meeting where they are bringing the work of the working party to the table for the first time. And on each occasion, there's a kind of sense of being shell-shocked by how rigorous the Council is in challenging the assumptions and the work that the working party is bringing to them. So people have to be really quite robust in working through this, and they're ready to do that. And they enjoy the benefits that come from it as well.
I don't think that tells you the whole story about consensus and how you get there, but I think that's a few of the things that contribute to it.
Impact. How do we measure the worth of what we do? How do we look for it even? It's very difficult, and, again, we won't find a definitive answer to this. We have tried to put some numbers on this. The reports that the Council published between 1993 and 2005, we examined all of the recommendations that we had made over the course of those reports, and we found that 53 percent of those recommendations have been implemented. And we're quite aware that we cannot claim a causal relationship between our recommendation and that implementation. However, we do know through the kind of personal contacts that we have, we do know through the kind of profile that we have, simply through working and living and talking in this environment that there is some measure of influence that the Council has had in those areas.
If we look simply at the last three reports, we can see some very immediate relationships between the Council's work and the consequences. In the end of 2006, the Council published a report on critical care decisions in neonatal medicine. It published what was really quite a controversial set of recommendations as to how premature neonates should be approached, how their treatment should be approached in intensive care.
This was taken up in discussion by a working party organized by the British Association of Pediatric Medicine. This included representatives from the Royal Colleges of Obstetrics and Gynecology and of Pediatrics and Child Health, the Royal College of Midwives. And they have recently now published guidelines that are based substantially and explicitly on the recommendations that were made in the Council's report.
We published about fifteen months ago a report on the forensic use of bio-information. This included recommendations regarding the taking and retention of DNA samples and the keeping of DNA profiles of people who had been arrested in connection with crime. In the UK, there are over a million profiles retained from people who have been arrested but have never been convicted of a crime.
A case known as Marper — one of the applicants was named Marper. The case went recently to the European Court of Human Rights. And the Court substantially quoted the Council's report when it effectively required the UK government to overturn its current policy on retaining samples from non-convicted people. So I think that we maybe haven't done ourselves any favors with the UK government, but the role of our reports in influencing the outcome of that particular case was really very substantial and very visible.
A public health report — I referred to that a little earlier — again, has been substantially quoted in some recent discussions over fluoridation of water. There is a statutory process now for considering how and when the water may be artificially fluoridated. And the Council's report in setting out, shall we say, the basis on which state intervention in public health can be justified, again, was used and quoted in those cases.
And we have ongoing discussions with government policy units over public health questions around obesity and alcohol. So we can see the profile we have in those discussions. And I think this is partly the value of making sure that our work is very much policy-focused rather than simply being — maybe this is a bit pejorative — rather than tending more towards the academic side, which it maybe has done in the past.
Of course, this is all terrific. But there are some limitations on what we can do and what we can achieve and how we're seen. There are some who occasionally suggest that the Council is unduly influenced by its funders, who are in the Medical Research Council and the Wellcome Trust in particular, clearly within the scientific and medical community. That influence is not there. But it is not difficult to see how some people might try to paint it. And we have to work against that and demonstrate our independence in this respect.
There is a question about representativeness. The Council is not compelled to try to cover all bases in the recruitment of its members. This is a strength, because it would be very difficult to construct a committee — I know that this happens in France. It happens in other European countries as well — to cover all religious and philosophical areas or professional areas.
We find it really quite difficult to imagine how a committee can be constructed in a way that would function in the way that ours does, but with those having to represent so many different areas. However, it does mean that we are left with a position where some people may claim that they simply have no voice. They have no representation there. We make sure through our process of fact-finding, of consultation, that everybody does have the opportunity to contribute, but this is a difficulty. And we do struggle with the notion of whether we should be looking for people from certain minority ethnic groups, from certain religious viewpoints, or from other philosophical viewpoints. And that self-examination will continue.
This question of our locus can be problematic. We have no formal power base, but our independence is a strength. So I think one can see some of these both as strengths and limitations.
In terms of responsiveness, we cannot respond and shoot from the hip on a question that arises in the press today or tomorrow. It's very tempting, but we cannot do this. The way that we work is to conduct these in-depth analyses. That is the strength that we have. But it does mean that sometimes people feel that we're missing an opportunity or failing to respond to particular questions.
What is a difficulty is capacity. Because of this, it means that we can only produce a certain output. Effectively, we average one report per year. We've got a long list of things that we could be looking at, but we resist the temptation to fire out quicker reports. It's clear from the feedback we get that the depth, the complexity, of our reports is one of our strengths. So we must resist the temptation simply to turn out more and more quickly.
These things are almost impossible to manage in a satisfactory way. Working from the base that we do with limited capacity, with our focus on big reports, what we would like to do in these areas are much greater than what we are capable of doing. The Council looked recently at this question of public engagement. This is not just about understanding the public but about promoting discussion of bioethics in the public arena more generally, not to encourage people to follow our line or to take up our recommendations, but simply to, as Marie-Hélenè put it, encourage the idea that civil society, that the strength of democracy is increased by reflection of these issues.
But we cannot educate the 60 million people of the UK. I don't know whether you can manage the 300 million people of the United States. But we just cannot realistically take on that task. And so there are several things that we do that are more limited in this field.
The international role is an interesting one. We have strong connections across Europe and across other parts of the world as well through European forums, global forums, with the work with UNESCO that has already been referred to. There are issues that are working on a global basis that we must be ready to look at and to look at with our partners across the globe whether it's about transplantation, embryo stem cell research, internationalization of medical research, the direct-to-consumer diagnostics and therapeutics. All of these things we're going to have to look at on a much more international basis than maybe we have in the past. So this international dialogue is really essential that we maintain it.
Public engagement I touched on. But young people, again — Marie-Hélenè touched on this as well — we recognize this is an important feature to enable people to increasingly from a younger age be willing to be ready just to find the language to talk about some of these issues. But we can't do this alone, and what we are trying to do is find partnerships in which we can work with younger people.
So we've worked with, for example, a touring theater company where we've fed in with our reports to several of their productions that they take out into schools and other areas. We work with the Nuffield Curriculum Center to produce materials that are made available to teachers through citizenship and science classes about animals in research and other things. We're working with the British Association with their after-school science clubs. And we're working at the moment with Teachers Television, which is a national TV channel that produces material freely available to teachers. So we're trying to work through other agents and other people on the back of their work and their resources to try and reach a bit further.
But the important part of this as well is that I think all of these things are about a commitment to be involved in this for the long haul, really to be working for the long-term. We are not only trying to deliver solutions to immediate problems, but also to realize that we're involved in a long-term process of engagement, of enablement, of discussion that doesn't necessarily produce distinct answers today. But we must have confidence that it's producing some additional quality over the longer term.
I'm running way beyond my time. I just have a few points to summarize, if I may. Forgive me.
I rather like this word, 'adhocracy'. We are really quite adept in the UK at finding practical solutions and to dealing with them there and then. What tends to happen, however, is that these worn-off practical solutions get integrated into the machine, and what we're then working with is quite an odd complex set of machinery. But then we become adept at working with that as well. And so this is something that, in a sense, is unusual. I don't think it is unique to the UK. But if the Nuffield Council is unique, well, it's within a system that enables it to be so.
Secondly, we have the separation of government and the administration. When the government goes, another one comes in, everybody else stays in place. I know this is different to how it is here. But what it means is that there is an acceptance of the durability, if you like, of people who within the advisory structures, whether they are statutory, non-statutory, or anything else. And so we can become a part of the furniture, even though we're not within the government machine, as it were. And there's an understanding and acceptance that those things can persist in that way. I'm just talking about, if you like, the uniqueness of our position.
The influence of the Council being based on quality and independence, this simply cannot be overstated. That is it. That's the top and bottom of it for us. If we didn't deliver this, we would pack up. That's the burden that, in a sense, I carry coming in as a director a couple of years ago to maintain the work that has been done in this over all of the years. But this is true for all national bioethics commissions. Whether statutory, whether governmental, whether independent or anything else, this has got to be true for all of them.
Finally, our interventions must be timely. They must be relevant to policy. We are not putting things on a shelf. We are not doing philosophical ground-clearing. We are trying to deliver things that have got a meaningful reasoning and a meaningful impact for questions that are distinct and timely. And just a few points of my own personal reflection. I don't think that if we tried to do it again we could do this. I don't think that we could replicate the position that the Nuffield Council on Bioethics is in the UK. And I don't think that you could recreate the conditions for it here or anywhere else. I think one can learn from the way it's worked, from how it succeeds, and on the limitations that it has. But I don't think that one could try to replicate it given a particular history.
The question of achieving consensus is an interesting and important one, and I think that it's essentially down to the goodwill of the people who are involved, an appreciation of engagement in this intellectual activity, and this non-alignment of individuals with particular positions when they put themselves in this place.
The question of striking a balance is one that over a number of years I've been saying this forever myself. We must find a balance between this and this. And I think that was all wrong. I think that it isn't a question of balancing things that are in two different places. I think that the Council would regard this as not a science or ethics, but science and ethics. These are things that work together, that one is strengthened by the other. Of course, there are times when there are things that are in conflict, but it's not essentially pitched in these terms.
Bridge-building is something that I think that we do a lot. This is between disciplines. It's between different communities. But I think more than anything else, I would suggest that one of the things that the Council does is find this bridge between academia and policy environments. And that's a really important one that hasn't always functioned terribly well, and it's something that I think that we do manage to do.
And finally, appropriately, I don't think we're looking to have the last word on any subject. The world will change. Science will change. Evidence will grow. And I think it would be really too much if we were to claim that we could have the last word in any debate or in any particular part of policy. But we would hope only that our work can enrich both the policy and the debates.
We will return to different questions. We will always have different questions to reflect on, and I think that, again, this is where we come back to the same points. It's the nature of the thing that we just keep on talking about it.
I wish you well with your deliberations today. It's going to be a fascinating day. I'm really looking forward to it, and it's been a real privilege to be invited to participate. Thank you very much.
CHAIRMAN PELLEGRINO: Thank you very much, Mr. Whittall. A member of our Council, Professor Elshtain, I asked her to begin the discussion, but she unfortunately could not make the meeting at the last moment and so I've asked Dan Davis to step in. Dan has had the opportunity to represent the Council on one of two international meetings so that he's pretty well alerted to some of the variety. And I've asked him, therefore, to open up for the Council and then provide the opportunity for the Council members to comment or ask questions. Dan?
DR. DAVIS: Well, first, I want to thank you both for traveling so far and for joining us today and for providing us with such richly informative presentations. And, second, I want to commend you, Madame Mouneyrat, for your stamina and fortitude in dealing with forty members. We have a Council of eighteen, and I just can't imagine what that's like. So I tip my hat to you.
The question that I'd like to pose — and you alluded to the subject matter of this question, Hugh, and as did you, Madame Mouneyrat, but I'd like for you to expand a bit on it — and it has to do with the matter of moral frameworks. And I pose the question because of the experience of this Council, which has in some of its publications appealed to the concept of human dignity.
And that appeal has been somewhat controversial. We were the target of some criticisms by some well-known American bioethicists who, in effect, argued that it was an appeal that was somewhat out of the mainstream of American bioethics, that we were employing a not-well-understood concept somewhat vaguely defined. And as a result, we actually rose to the challenge and attempted to explicate that concept, not in a univocal way but by publishing a document that offered twenty-three different perspectives on that particular concept.
So I'm interested in the moral frameworks that emerge or that you employ within your own work and how you have gone about developing those. I know that certainly the concept of human dignity is one that has a much greater resonance in a European context than it does here in the United States. But I think part of our argument is that it has a universal significance and, thus, although it may not be one that's resonant with the American tradition, it's one that we should consider in dealing with some of the challenges of bioethics today.
So if you could comment a bit more on that aspect of your work?
CHAIRMAN PELLEGRINO: Madame Mouneyrat?
SECRETARY GENERAL MOUNEYRAT: Thank you for these
questions. It's a very difficult question. As I said, we tried to
begin at the beginning of the work of the Committee to see if we
can have principles like human dignity, making this allusion.
I think that human dignity is, as you said, at the heart of the reflections of the French national committee. But when you have said "human dignity," that's not whole. What is concretely human dignity and you can think about, I think, in reference. But what is undignified and it's a concept which is at the heart of the reflections of the committee. But we try to define it and it's rather difficult at the heart of the concept of human dignity.
But you have also after that secondary concepts that are very influential
like informed consent, like the principle defined by the Philosopher
Kant, which is to consider each person as an end and not a [means].
This is very, very important and always at the heart of our reflections.
There is another principle which is nowadays, I think, very important,
the principle of the status of the human, of the person. And as
I said, the question about the status of the heart of a person and
the — what we call in French. I am sorry for my English —
the "commercial" use of the person or part of the person
is a very fundamental principle which is now written in the law.
But in the context of the re-examinations of the bioethics laws
were very important pressures for admitting, for instance, surrogate
motherhood. We very well see that the whole principle of the non-commercialization
of the body and of the person is going to be put in question.
CHAIRMAN PELLEGRINO: Thank you very much. Carl?
DR. SCHNEIDER: I have a rude mechanical interest
in what actually happens after reports issue. You said that they
were quoted, and you gave an example of a quotation and judicial
opinion. I spent two years writing judicial opinions in the United
States, and I'm afraid that the fact that something is quoted an
opinion probably tells you more about the anxiety of the drafter
or to find somebody else's words to use instead of inventing his
own than it does about where the idea comes from.
So my first question is, is there any reason to think that these kinds of councils actually change the way that policy is that would not happen in the absence of the council? In other words, I think that most of the things that councils say they say because cultural and ideological trends move them in that direction. But they're moving everybody in that direction, and if it weren't this council that does it, it would be that council that does it.
The second question is, assume that everything the council suggests gets turned into law and policy and practice. Is there any reason to think the world is a better place for that? Is there reason to think the world is actually a worse place for that?
MR. WHITTALL: I think that we probably, all of us, should challenge ourselves regularly with those kind of questions about whether what we're doing is really much more than a bunch of nice people getting together and talking about the things that we like talking about together and telling them to each other. It sometimes, I think, could be a risk.
I think that it is probably true that there are cultural and ideological trends, and that we are, if you like, in the current of where they're going. But that doesn't mean to say, first, that we can't influence the direction of those trends. And we should be aware of them. We should be able to identify them. We should be able to understand, try to understand, what's in them and try to have some impact on them. And this is, I think this is the point about having some regard for the long-term that we're engaged in here.
And on the second aspect of this is whether we have any impact on specific outcomes in terms of particular policies. And I think, you know, each council can take a view on the degree to which it wishes to engage at a really broad ideological level or a rather more specific policy-focused outcome.
And I think that if we examine our work and we do try to have quite clear policy-focused orientation and we do engage with the individuals who are involved in making, examining, and changing those policies, as I said, it's difficult to produce hard evidence that this wouldn't have happened had it not been for us, but we're certainly in amongst it. And policy is an imprecise business that is filled with all kinds of influence, and it's not simply good evidence always.
But I think there's reason to be self-critical. There's sometimes reason to be skeptical, but there are certainly good reasons to stay in amongst it.
DR. SCHNEIDER: Are there reasons to think that the policies that you've proposed that were put into law or practice actually achieved their goals and did those goals turn out to be good goals to try to achieve?
MR. WHITTALL: I'm not sure that there's good enough evidence. And, in fact, it's one of the interesting questions that we've increasingly focused on in recent times is the need for evidence both on the construction of arguments and in the critical evaluation of them afterwards. So I think I would just essentially take your point that we need to maintain a collection of evidence about that.
CHAIRMAN PELLEGRINO: Dr. Dresser?
PROF. DRESSER: I wondered if Madame Mouneyrat wanted to respond to Carl 's question.
CHAIRMAN PELLEGRINO: Would you like to?
SECRETARY GENERAL MOUNEYRAT: Yes, I'll try to be brief on a very difficult question. In France, the exact title of the French national ethics committees is French National Consultative Ethics Committee for Health and Life Science. So it means that we have no power of decision.
We try to have a power of influence, but I think the difference,
we are always into... We are criticized on exactly two opposite
positions. One kind of criticism is to say you are only consultative
so you are not useful. You are a group of citizens which likes to
think together and no more.
And if our opinions, recommendations, have some kind of influence
[then we can be told we] are not a democratic institution, and [we]
are only consultative and [we] go too far for our role. So I think
that we have to deal with these two kinds of approach. And it's
not so easy and, as Hugh said, we have to think about this difficulty
during all our work.
That's why one thing I want to say is [there is] a very important
difference between opinion and recommendation. If you give opinion,
you give an opinion open to debate, for societal debate, for the
political debate, for the parliamentary debate.
If the committee gives a recommendation, it goes further on. It
has been considered [to be] contrary [to] our strictly consultative
What I would say also, in France, as I said, we are publicly funded
so we have to be evaluated. There is a recent law in France which[requires
organization] which are publicly-funded to [have their performance
evaluated]. And there is nothing much more difficult than to evaluate
how a national ethics body is performing and [it is] difficult to
find criteria for evaluating this performance. It's clearly not
the number of recommendation or opinions [issued].
In France, we choose to evaluate our performance with criteria
linked to how many visits we have on our web site. So what is the
interest of the society [in] our work? And the second criteria is
[whether] the press is interested and how many articles in the newspapers,
on the TV, on the radio we have at the end of each press conference.
It's clear that one other criteria is the way the parliament follow
up on our recommendations, but it's not the major one.
I don't know if I answered [your question fully].
CHAIRMAN PELLEGRINO: Thank you very much. We have five members of the Council who wish to comment. I am going to extend the time by fifteen minutes, but no longer than that. Otherwise, we will invade the time of the subsequent speakers. So I have Dr. Dresser, Dr. Meilander, Paul, Alfonso, Janet, if I make it quickly to give your first names. We'll try to do it in the time available, I hope, and then go on to the next session. Rebecca?
PROF. DRESSER: Okay. I was very interested in the comments about fostering public engagement in education. I think in the United States there has been an emphasis on the policy focus of commissions. And from my experience, I believe that education should be equal, if not greater.
I know for me the most rewarding part of being on the Council has involved participating in programs at colleges and universities. And we've had students visit our meetings and so forth. So I wonder if you have advice about how a national council should be set up in terms of personnel and operations to promote that part, that function?
I was interested in you said you have a yearly conference. Is that open to the public? Is it large? How does that work? Those kinds of things.
MR. WHITTALL: Shall I just answer first? I mean, I think Marie-Hélenè will have other things to say.
Firstly, I agree with you that that is an important function, and I was keen to point out within our terms of reference there are three elements. One is identify issues and explain them, one is make recommendations, and one is to promote public discussion and understanding. That is, in my view, the most difficult one. And I don't think that I can probably tell you what is the best way to do it. All I can do is say what we can manage with the limited resources available, but there are a couple of elements.
One is that there are several members of the Council who take a specific interest in this area. So I think that you need to have a clear commitment on the part of some portion of the council to do this work. So we have several members who sit on an advisory group where we draw in expertise from other areas of education, of youth work, of media and communications expertise.
So we have a separate advisory body that helps us with the work that we do in trying to push out, mostly to young people, because they are a captive audience. They're the easiest people to reach simply because you can go through schools, you can go through places where they are likely to be. We haven't yet cracked social networking through the Internet. That's something that we need to look at next because we are just so way off the pace with how information and ideas and conversations are taking place.
So I think that we need to use our advisory group to push us into some of those other arenas where you've got people and you can put things in there, and they want to talk about them. They will talk about them, and they will talk about them well. But we just haven't yet reached nearly as far as I think we probably could and should.
SECRETARY GENERAL MOUNEYRAT: Yes. As you said, we organize each year an annual conference, and it's the law. The law makes us the obligation to organize such a conference which is completely open to the public. You have in the newspapers announcements in the newspapers and everyone can come and attend without any kind of an invitation.
So for the young people, we are not as well organized as the Nuffield
Council. And we [work] in a very pragmatic way. We have a network
of teachers from Paris but also from every place in France, which
are interested and who work with us voluntarily and with the young
people during months and months on subjects they have chosen. They
are very free to choose. And sometimes members of the committees
go to the schools and have a dialogue with the students and the
teachers to prepare for the annual conference which takes place
But the difficulty in France is two kinds of difficulties. It's
that in the programs you have in teaching are very rigid programs.
Bioethics teaching — I would prefer to say sensitization —
is not written in the programs. So the teachers and the pupils are
obliged to volunteer to work more [on an extracurricular basis]
and it's not so easy because [students] have exams at the end of
And I think that one thing which would be very important is [for]
the education minister [to] accept ... that ... teaching bioethics
is important for the pupils and they have hours very concretely
written for that. And I should say that the program [exists] for
the high school students, but it's more important for the medical
In France, the studies in medical science [do not focus] on bioethical
questions. And when we have students, we see that we have students
in law and philosophy [studying bioethics], but never students in
medical science. It's a really great problem in France.
CHAIRMAN PELLEGRINO: Dr. Meilander? But before you speak, one second, I'm going to use my Chairman's prerogative again and suggest a slight change, because the time is getting very short. If our Council members will present their comments and our visitors will hold, make notes, and comment on those parts of it you wish to make a contribution. Gil?
PROF. MEILAENDER: This is really a question, I think, primarily about the work of the Nuffield Council, but it grows out of observing a sort of difference on the matter of consensus. I mean, you emphasized very much the desire for consensus, whereas, the French body is, in fact, structured in a way that doesn't always lead to that.
And, in fact, if I understood you correctly, you said that you
have achieved consensus on each of your reports. That strikes me
as very strange. It suggests a need for broader horizons or a wider
range of opinion. And you ascribed it at one point to the fact that
the people who come under the Council understand themselves or are
committed to — I don't have your exact language — but
something like non-alignment with particular positions.
And I would think that even a willingness to think that it was possible for me to be so non-aligned is, in fact, a philosophical position that one has taken up. So I'd just like a little more reflection on consensus and whether, in fact, these people really are non-aligned from the start.
CHAIRMAN PELLEGRINO: Next I'll ask Paul McHugh.
DR. McHUGH: Well, first of all, I want to thank you both very much for coming to talk with us. And it's extraordinarily illuminating for us to hear from councils of bioethics and other sources from other countries illuminating what we are thinking about and seeing things that are common amongst us and things which are perhaps different amongst us. And so I'm very, very grateful to you, and I'm sure I speak for many others here.
I have two questions, and they've been adumbrated in the other questions that you've been asked, but they perhaps sharpen it just a little bit. The first question really derives and relates to Carl Schneider 's point about how you might show that you are effective.
And that brings to mind that you came into being at a certain time, presumably facing something that you needed to be effective about. Maybe 1991 was an important year in Britain. Maybe your country was concerned with some particular issue, perhaps the genetics of brussel sprouts or something of that sort. And so my question is, now that you have come and existed, do you think on reflection back on other arenas of science and society that you would have had, if you were in existence, that might have avoided the terrors that happened at that time?
For example, in the United States, the eugenics movement was a scientifically promoted and developed process and democratically expressed idea in over thirty-seven states in our country where sterilization of the mentally retarded was promoted into law. And ultimately it was expressed in the most vigorous form, but perhaps one of America 's most distinguished jurists, who supported such sterilization of these people by saying, "Three generations of imbeciles is enough." That was, everybody knows, Oliver Wendell Holmes, Jr. And the case was Buck v. Bell.
And do the councils that you have now, the working parties and the kinds of approaches that you have of bringing people in, would you on reflection see that the process, the democratic process, in these states would have been aborted in such a terrible decision by our Supreme Court could have been obviated? That's the first question.
The second question perhaps is a more playful question particularly directed towards our French friends. And it comes from the emphasis is both of you though have had on the young and your identification of the young as the people you want to work with. But it was a great Frenchman who once said that if you're not a communist when you're young, you have no heart, and if you're not a conservative when you're old, you have no head. And so what I'm asking of this is, in what way are you either supporting the heart of the young or the head that they might eventually have by the process that you have in mind?
I believe, of course, that the problem for the young, the natural problem, because I remember when I was young and very left wing, my problem is related to a lack of prudence in some of the things that I would propose, an ignorance of, and therefore not a sufficient respect for the traditions that have formed the cultural heritage, and an unawareness of the fragility of the institutions of our society such as the university of the family. So those are the questions that I have for you.
CHAIRMAN PELLEGRINO: Thank you. Next I have Janet Rowley? I missed Alfonso — excuse me. My handwriting is not clear. Would you yield?
PROF. GÓMEZ-LOBO: Yes.
CHAIRMAN PELLEGRINO: You have it, Janet. Go ahead. Alfonso will follow you.
DR. ROWLEY: Well, I have a comment and a question. And the comment is more for Madame, that at least now by law or at least by the practice of the National Institutes of Health and some of our other scientific things, ethics is at least taught to the graduate students because they have a required course in ethics. Now, these aren't medical students, but I'm sure that the medical students also have exposure. So at least that aspect is taken care of.
But the question I want to ask to each one of you because our Council is more parallel, I think, at least in its derivation to the French system than to the Nuffield Council, each one of you, you've sort of articulated why being either totally independent or in some way having some governmental responsibilities have directed how you proceed.
As we think about recommendations for the future, if there is a future of bioethics councils, except that we've had them repeatedly over years, I would very much appreciate your reflections on would you have preferred to be more independent or would you have preferred to have a greater role in the governmental process?
CHAIRMAN PELLEGRINO: Thank you, Janet. And the final question for this morning — then we'll have the answers from our visitors — Prof. Gómez-Lobo, thank you for your graciousness.
PROF. GÓMEZ-LOBO: Thank you for the two wonderful presentations. As I was hearing those presentations, I was puzzled and I'm going to formulate a short question to Hugh, if I may.
And it's this, that these are two bioethics councils deliberating about bioethical issues. Now, bioethics as I understand it is a field of applied ethics or moral philosophy, and I think there's a very, very solid argument for showing that moral philosophy cannot be done inductively. In other words, you have to make up your mind on principles of some sort.
Now, to say that a council is pluralistic is really not to solve the problem at all, because the problems will arise.
Now, Hugh did mention an intervention by John Harris. Now, I'm not sure I understood it correctly, and I will ask you to briefly expand on that. In other words, what would the role of such person be in the Nuffield Council? And the further question would be, would you call upon other philosophers in the field to play that role, if I'm understanding it correctly? Thank you.
CHAIRMAN PELLEGRINO: Thank you very much. Now, may either of you want to respond in what order, either of you? Ms. Mouneyrat?
SECRETARY GENERAL MOUNEYRAT: Yes. I will try to make a brief answer to your various questions.
As I said, the question of the consensus is a very important question
for us. And I think that what is important is, I repeat it, how
to stimulate the social debate. And the question which has been
raised by our former President, Jean Pierre Changeux, is to know
if it's easier to stimulate the social debate from a point of consensus
with the risk of the difficulty to contest to consensus or if it's
easier to have this debate with only different arguments and points
of view. I don't have the answer of the question, but I think that
it's this way of approaching the question which is important.
For the eugenics movement and the effectiveness and the democracy
expressed, yes, I think that you raised a very, very important issue.
And I will respond also about the young. We have to be very cautious
regarding what can be [seen to be] considered as [an] expression
of democracy. And why? Because I think that influence — and
nowadays we can see it — we have more and more influence [from]
the lobbyists and [from] the media, as I said, because it's easier
to transmit a very strong and clear cut point of view. And we can
be very careful that this expression does not become the expression
of the democracy.
And for the younger people, you are very right. The danger is the
very interest and for what they think to be the modernity and at
the name of the modernity to participate in change or is existing
in all institutions. But the experience is that it's their first
position. And [in] the name of the modernity we abolish any principle,
any barrier, et cetera.
But when you take time for having a very calm and quiet discussion,
they begin to think and when they say that it's a success and to
say, "Oh, yes. I didn't think about that. It's not so easy
as I thought." So that is our job. We try to do it, not perfectly,
but it's our aim.
One final word for our independence. Yes, I think that as I said and as Hugh said, we have to try to maintain very, very strongly what we consider to be our independence because, as you said and I said, it's one main condition of our credibility. And if we have no credibility, it's impossible for us to play a role in the elaboration of a social debate.
CHAIRMAN PELLEGRINO: Thank you very much. Mr. Whittall?
MR. WHITTALL: I will be very brief, although, I think that one or two difficulties arose because I was already being too brief.
I think you're right to pick up this question about non-alignment, and that needs picking apart a little more. I think it's not to say that people don't have positions or they don't associate themselves with those positions. But, rather, the fact that they are not there in order to represent a particular group of people means that they don't have to simply say, "Well, I can't accept this because I can't go back to my people if that is the final position."
So I think that to say that they're not there to represent a particular group or a particular position frees them up from feeling that they have to commit themselves only to one particular outcome. I think that's as much as I will say. Of course, people do have particular beliefs, particular professional associations, and we can't suggest that that won't be the case.
I think the question about, were there critical issues that brought this about or that would have been different had the Council been there at the time, I think there have been a few critical issues over a number of years, going back to certainly the early '80s when the debates over embryo research were taking place. A few years later when the first debates over genetically-modified organisms were taking place, I think they were highly problematic.
Now, there were one of two subsequent ones as well and, even in more recent years, around the use of human tissue, commercialization about all sorts of things, where I think that certainly people within the medical and scientific communities were finding it very difficult to manage that kind of political environment that surrounded that. A number of those found a lot of conversations going on with people in different disciplines and realized that some of these discussions could help see all of those things through.
Now in some cases, this was successful. And I think that part of the reason for having an organization like the Council was about saying, "Well look, we need to have a place in which we can see that kind of discussion conducted." It was not successful in the case of genetically-modified organisms. I think the way the policy ran was really problematic in the UK. And the process of dealing with embryo research was probably much lengthier than it needed to. So I think you could probably identify some things where things may have been different. But, of course, we can't say for sure how.
The question of how and why we're engaging young people, I don't think that we would want to take the energy and the heart out of how young people approach some of these questions. But in talking to educationalists, one of the things that struck us very forcefully was teachers in the classroom, whether they're teaching science or citizenship, will raise a question, for example, about use of animals in research and then what they see is chaos. The class will fire off in all directions. Fine. But it's very difficult, then, to find a way in which to manage that into a productive debate.
And one of the things that we can do is to offer, if you like, information, materials, structures in which those debates can then be conducted, not to try and instruct people in any particular direction, but to give them a language and a frame in which to conduct that kind of conversation. And that I think is beneficial, not just in that particular instance, but for the way that people are able to have these conversations anyway.
Independence, I think if you ask any member of our Council, "Would you like to move closer to any government institution," the answer will be no. Quite clearly, I think for those of us who have worked in those institutions and have moved away, I think we would prefer to stay in the position we are. I don't think that's necessarily right for all people in all cases, but that's just a reflection of where we uniquely are.
Again, John Harris' report, by the way, was something that we asked to be conducted, not for him to give his view, but simply to, if you like, gather up what the Council had done in the past to help us to identify, if you like, what were the features of the Council's body of work so that we could reflect in the future how we wanted to put things together.
And, yes, one does have to identify and commit to sets of principles. And in each particular case, I think the point was that emerged from that, that's it's necessary to be explicit, to be transparent, to show why you've worked with those principles, why that framework is operative in this case, and be ready to have it challenged and discussed as well. And it was just a way of opening up that as clarifying that that's the process by which we work.
CHAIRMAN PELLEGRINO: Thank you very much, Council members and the visitors, for allowing me to manipulate the schedule. But I do feel a responsibility to those who come later to have an opportunity to express themselves as well. I think we can have a break now until 10:10 — oh, 11:10.
I haven't changed my watch. This is reminiscent of my failure to adapt to modernity from back in the Middle Ages. Thank you for your additional indulgence, but we will be back at 11:10.
SESSION 2: NATIONAL ETHICS COMMITTEES: MISSION, FUNCTIONS, PHILOSOPHIES, AND MODUS OPERANDI
CHAIRMAN PELLEGRINO: Thank you. Thank you all for assembling. Cynthia, you can join us up here now. This is the Cohen chair. Thank you all for returning approximately on time.
The next session is on the Mission, Functions, Philosophies and
Modus Operandi of National Ethics Committees. And, as I pointed
out this morning, we do not provide lengthy bibliographies. Titles
will be sufficient for these introductions.
So the first person on the program this afternoon is Dr. Cynthia Cohen, Faculty Affiliate at the Kennedy Institute for Ethics, Georgetown University and an old, dear friend. I hope I can add that little bit without extending the program too much. Cynthia, we're delighted to have you.
DR. COHEN: Well,
I'm very happy to be here and thank you very much for inviting me.
In the early 1970s, there were outrageous abuses of human subjects
that were brought to light. A congressional committee discussed
them. They became a matter of public knowledge. And the sense of
outrage was such that Congress decided that it had to establish
a national commission to address issues pertaining to the use of
human subjects in medical research. This was the first national
There have been five such commissions subsequently, and I have been asked to speak with you about the goals and roles of these commissions, their membership, their methods of deliberation, their guiding philosophies, and how well they functioned — in 30 minutes. So I will necessarily be selective.
And my basic question is whether there is a valuable social role for a federal commission devoted to questions in bioethics.
Let's return to that first national commission. It was established
in 1974. By the way, there should be handouts for members of the
Council — and I believe for the public — that provide list of what
the various commissions have been so that I didn't have to do a
PowerPoint of them all. But I hope that you'll learn enough, if
you don't have access to one, from what I say so that you'll be
able to follow along.
The first one was called the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research. It was
placed under the auspices of the Department of Health, Education,
and Welfare. It was an advisory body and had a limited term, although
there had been some discussion of making it a permanent body. Its
basic mandate, would you believe, was to identify the basic ethical
principles that should underlie the conduct of biomedical and behavioral
research — a very tall charge.
It had more specific charges, which included evaluating the effectiveness
of various institutional methods of overseeing human subjects research
because there were methods in place already and to consider additional
protection specifically for children, pregnant women, fetuses, prisoners,
the institutionalized mentally infirm who were asked to become subjects
You've probably heard of the Belmont Report if you're interested in this area. It is the report that the Commission is best known for. It provided the basis for far-reaching federal regulations for the protection of human subjects. And in the course of doing so it created a new social institution, the IRB, which provided a research review process that was guided by clearly articulated principles and procedures.
The Commission provided reports on the issues that it was charged with addressing — I won't go through the whole list — and then finally a comprehensive study on ethical issues raised by advances in research.
This Commission had greater power to control the development of policy than subsequent commissions because its charter required the Secretary of HEW to respond to its recommendations within 180 days. If the Secretary decided they should not be followed, he or she was required to publish reasons for this in the Federal Register. So it was clearly easier to accept the Commission's recommendations than not. Efforts to transform this Commission into a permanent body at the end of its term were unsuccessful.
And in 1978 the Secretary of HEW developed a body known as the Ethics Advisory Board on the recommendation of that first national commission, and its role was to develop policy regarding research into IVF — in vitro fertilization — fetuses, et cetera, and to review research proposals involving them so that it was a two-pronged charge. It had the practical charge to review actual research proposals and the more policy-oriented charge of developing some sorts of guidelines and policies regarding them.
It published a report on IVF in 1979. But the first child born of IVF appeared on the scene at that time and there was tremendous controversy about the use of embryos, the use of IVF, and the EAB was terminated in 1980 presumably due to political considerations.
This meant that no federally-funded IVF research could take place
because the board that was supposed to review this research was
non-existent. Soon after though, in 1980, Congress once again created
a national bioethics commission, the President's Commission for
the Study of Ethical Problems in Medicine and Biomedical and Behavioral
Research. I'm going to refer to it as the President's Commission.
Although it was called the President's Commission, it was established
by Congress. Its mission statement was breathtaking. It had a general
clause as did the first commission about principles. It was to address
informed consent, the definition of death, decisions to forego life-sustaining
treatment, and genetic testing and counseling as well as differences
in the availability of health services. It was free to take up other
related matters. And, of course, at the instruction of others, it
would take up their required or suggested issues.
Its report "Defining Death" set out the whole brain definition
of death and the foundations of the Uniform Determination of Death
Act. Prof. Schneider was wondering if any of the French or UK groups
had had any practical impact. This is one practical impact that
a US commission had. This Act was subsequently adopted by all US
Another report, "Deciding to Forego (sic) Life-sustaining
Treatment," had a major effect on the way in which end-of-life
care was and is provided in this country, not only in a legal sense,
but also in a medical sense in terms of public awareness. It produced
ten reports in a little more than three years. Several of these
provided careful analysis of some widely-held but contrasting views
on ethical issues, but some of them could not resolve them. Its
work had a significant impact due to public interest in the topics
and also by efforts by commissioners to establish contact with Congress,
the media, and the public.
In 1988, a Biomedical Ethics Advisory Committee was created by a Congressional Biomedical Ethics Board. That Board consisted of six senators and six representatives. However, it deadlocked about its membership concerning pro-choice/anti-abortion issues and the Committee simply could not actually be appointed, much less function. It had two meetings before it died in September 1989. So I won't be talking much about that Commission because it didn't do anything, and I won't be talking about the Ethics Advisory Board because it never really was able to do much.
However, after a six-year hiatus, in 1995, President Clinton established
the National Bioethics Advisory Commission by Executive Order. So
this was not Congress, it was the president. It was to advise the
president, the National Science and Technology Council, and other
appropriate government entities regarding bioethical issues arising
from research on human biology and behavior and the applications,
including the clinical applications, of that research.
Its major task was to advise federal lawmakers about legislation, regulation, and policy regarding sensitive bioethical issues. It began work in relative obscurity. But four months later scientists announced the birth of Dolly, the first cloned mammal, and President Clinton asked NBAC to prepare a report on reproductive cloning within 90 days. It did so somehow. The staff got beefed up and members worked tremendously hard. A lot of outside consultants were brought in.
It recommended a moratorium on reproductive cloning. However, this
recommendation was not enacted into law due to differences among
members of Congress about the issue of reproductive cloning and
research cloning. But its report was widely publicized.
NBAC moved from one briar patch to another. It was asked to do a report on stem cell research after the development of human embryonic stem cells in 1998. The President made it clear well before that report was issued that he would not support the adoption of one of its forthcoming recommendations to use federal funds for the derivation of human embryonic stem cell lines from human embryos.
Again, there was widespread discussion of this report, even though the President made it clear he didn't favor parts of it. I think one of the reasons it received widespread notice was that it had a very interesting discussion of the religious views of the moral significance of early embryos.
NBAC produced a total of six reports that addressed ethical and policy issues pertinent to persons with mental disorders, human biological materials, clinical trials in developing countries, and research involving human participants. Some of its recommendations were accepted. For instance, several of the detailed recommendations in its stem cell report were built into the guidelines of an NIH task force that was set up to oversee stem cell research that was to be funded by the NIH. That task force had its first meeting canceled and never met, so those guidelines were not put into effect due to a change in administration.
It's arguable that NBAC had an impact on various federal agencies such as the FDA and the CDC in that they responded to its reports. So this indirectly, or perhaps directly, indicates that it had an impact on policy development. Its work ended five years after it began in October 2001.
In November 2001, President Bush established the President's Council on Bioethics by Executive Order. Its charge was very broad. It was to advise the president — no other public officials or agencies were mentioned — and was to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology. It was also to explore specific ethical and policy questions related to these developments. So it was not only to discuss general matters but to look at specific issues and to provide a forum for national discussion of bioethical issues. There is no sense, though, that it was to perform these tasks as a prelude to legislation.
The President's Council has had the longest life of any of the six serving from 2002 to 2009. It has considered specific developments in biomedical research as charged, cloning, and stem cell research, for example, and it has prided itself on addressing these from a broad prospective. It has also addressed more general issues that we face as human beings in search of the human good.
The Council has produced a slew of reports. The one on Alternative
Sources of Pluripotent Stem Cells appears to have been the
only one — and you correct me on this — the only one to have
had a specific response from Congress. There was legislation passed
that took up several of its recommendations.
Other reports such as those on enhancement, "Being Human,"
and "Human Dignity," have been directed to the educated
public. In them, the Council has sought to persuade readers of the
importance of a set of ideas and questions. Clearly, the primary
role of the Council has been educational.
As this discussion of the charges of these commissions suggests, these commissions have played several different but interrelated roles. Initially, their function was to recommend ways in which government agencies could address certain unethical practices related to the pursuit of biomedical research. So they've had an activist-reformist charge from the beginning.
In carrying it out, they've sometimes played a quasi-legislative role as when the President's Commission stepped into a major legislative breach due to disarray about the definition of death and produced one that was written into law.
National bioethics commissions have also been called upon to promote
a national discussion of ethical questions that have been raised
by specific developments in biomedical sciences. This is the case,
for instance, when the National Bioethics Advisory Commission addressed
research on human biological materials. In this role, they've sort
of served as a crucible to define more sharply what's at stake ethically
for policymakers and the public. And as this example suggests, their
educational function has often led them to perform their activist-reformist
function as well.
They've not always been successful as you may have concluded from my opening discussion of them in this function. For instance, the National Commission's report on providing special protections for those institutionalized as mentally infirmed was never adopted due to conflicts among relevant interest groups. The National Commission, by the way, was the first.
National Bioethics Advisory Commission — I don't know if I should
say numbers, but I hope you're hanging in there and following me
with which commission I'm talking about — that was the one under
President Clinton — and the President's Council on Bioethics under
President Bush had little success in enticing the president or the
Congress to introduce policies they had recommended with regard
This leads me to another purpose for which these councils have been formed, a political one. Some say that one commission or another has been created to advance the political agendas of liberals or conservatives. NBAC had a goodly dose of known political philosophical liberals and the President's Council of known political philosophical conservatives giving weight to the belief that political affiliation was a consideration in the structuring in of their membership.
Others maintain that some of these commissions have been political
in a somewhat different sense. They have allowed the president and
the Congress to toss hot potato issues in their direction so that
they could be rid of them and not have to get into deep political
grounds. So the National Commission was the dumping ground for an
issue that was too difficult for the ordinary political process
to handle, fetal research.
Meslin and Shapiro suggest that assigning NBAC to review human stem cell research had the dual political effect of focusing national attention on the subject and yet defusing the urgency associated with it.
It should be pointed out that national bioethics commissions can
play political roles on their own initiative and terms. They can
bring pressure to bear on the Congress and government agencies to
pursue certain policies as did the President's Commission with regard
to the definition of death. I see some of you smiling back there,
but it really was the case back in the olden days, I guess. As such,
their educational function rolls over into a watchdog function.
As Dr. Pellegrino has observed, there are ethically sound ways
of being political and ethically unsound ones. Such commissions
have an implicit charge to use their watchdog function in ways that
are ethically sound, no attempt at political blackmailing, for instance.
What about the composition of the councils? Given their roles as discussed so far, who should be appointed to these commissions? The educational and activist roles that they have would require a diverse membership. Commissioners need to provide ethical and social perspectives and professional expertise on a given topic.
The National Commission, for instance, drew five of its eleven members from the research community and the other six from such areas as — this is a long one — medicine; law; ethics; theology; the biological, physical, behavioral and social sciences; philosophy; humanities; health administration; government; and public affairs. So that was going to be for six.
The President's Commission was larger. It had eighteen members.
They had a similar background requirement except that the NBAC members
included, in addition, members of the general public. I won't go
into detail about it. The President's Council does not have a similarly
broad requirement for its members, does not include public members.
No federal bioethics commission has formally designated a bioethicist
as a member, although certainly there have been people who call
themselves bioethicists who have been appointed probably under the
rubric of being an ethicist or in the field of ethics.
Some contend as the commission movement developed membership tended to be composed primarily of bioethicists and became somewhat clubby. Members tended to know one another from working together on other sorts of bioethics groups or other groups that weren't necessarily focused on bioethics. They seemed to adhere to the same language and conceptual framework that led to certain conclusions. And some maintain that when a commission has no dissenters to its recommendations, its members have been drawn from the same school of bioethical thought rather than a more representative and varied background in ethics.
In a related vein, the liberal-conservative dichotomy has become an issue with the appointment of members known to be politically liberal or else conservative. One argument for doing this is, if you tried to appoint members with an eye to balance in terms of political convictions, this could result in polarization and an inability to get anything done. Perhaps the answer is to select members who are known to be open to understanding different and even opposing points of view, even though they themselves tend in one direction.
The staff plays an important role in the work of these commissions. The President's Commission, for instance, had a staff of about twenty. They prepared, revised and disseminated its reports. The staff, though, should not be allowed to control the discussion. You might be interested in the issue of the Kennedy Institute of Ethics Journal that's just coming out. There's an article by Dan Sulmasy in it that talks about the role of the staff with regard to the work of the New York Stem Cell Task Force, which he found to be most unhelpful, and I will leave it at that.
Methods, Mode of Deliberation. We live in a pluralistic and fractured society in which citizens manifest many conflicting theoretical persuasions and notions of the good. It seems that we lack common ground that could serve us in good stead in addressing fundamental value conflicts. And yet the basic charge of three out of the four main commissions, forgetting or setting aside temporarily the two that really never were able to function, the basic charge that those three commissions had was to sort through the ethical issues at hand and to address them. And when I say three commissions, they had specific assignments: address these issues, do something about them.
Well, how did these commissions proceed? We know that, although
the National Commission didn't adopt a basic ethical or political
theory, three basic principles emerged from the Belmont Report
to govern research ethics, which curiously surfaced
in the UK analysis that John Harris did — respect for persons,
beneficence, and justice. According to some commissioners, these
principles did not emerge full-borne from the heads of the commissioners
during discussions. They were developed as a sort of afterthought
to meet their charge to develop some principles. This was their
So what did they do during the working hours? Jonsen and Toulmin
who served on this commission in different capacities observed that
commissioners could agree on some rather vexing issues in research
ethics, for instance, and yet disagree strongly about the rationale
behind their respective positions. They reached agreement, Jonsen
and Toulmin maintained, by starting from paradigm cases of what
they took to be ethical research and reasoning analogically from
them to more marginal or problematic cases so that they basically
used a case-based method. But they invoked their preferred ethical
theories on a broader plane or their religious beliefs to explain
and justify their votes. And when they did that at times disagreement
After the Commission — the Commission sort of sifted out, what
are the three principles? Apparently, they did this in the home
study of one of the commissioners because they were just having
a terrible time meeting the charge. They drew these principles together
and then dumped them on Tom Beauchamp — Tom Beauchamp was on the
staff of the President's Commission — and said to Tom, "You
figure out what they mean." Well, Tom, of course, went on to
make bioethics history along with Jim Childress by developing these
and a fourth principle into the mid-level principles of bioethics.
The second commission, the President's Commission, in contrast did not explicitly develop a set of principles. It used a variety of argument forms depending on what was at issue to reach its conclusions. Some of these implicitly used principles of bioethics. But basically the group was trying to figure out reasons that most of its members would agree to for its conclusions because there was a heavy push toward consensus from the chairman who felt that anything they came out with would be useless unless it had the firm backing of the vast majority of council members. So some critics say it actually wound up putting out rather watered-down reports, taking very complex issues and oversimplifying them. But I think others would argue against that view.
The National Bioethics Advisory Commission aimed to reach both policymakers and the general public. So, for instance, in its stem cell report, it began its discussion by saying it would attempt to resolve ethical and policy disagreements by referring to shared views, the public consensus, and common ground. But it maintained it would not accept shared views blindly. It would only do so when these could be supported by sound deliberative reasoning. So the quality of reasoning used to reach consensus mattered.
Now, John Rawls ' name was not, to the best of my knowledge, specifically mentioned in NBAC's report. The work of others who drew from his thinking was. I'm going to run out of time if I go into this in too much depth. But basically let me just say that people built from his ideas.
He basically had a notion that procedure was very important in
the way that you reached conclusions in a liberal, broadly-speaking
liberal, democratic polity; that there were some basic essentials
that people had to work with in such a polity. These were Constitutional
essentials and the principles of justice, which could be used procedurally
as well. And he put a great deal of emphasis on the duty of civility,
that people ought to sit down, listen to what other people are saying
with whom they disagree, try to meet them halfway, figure out if
there's some way of getting their views together in light of what
he called "public reason." And he eventually took a position
where he was open to bringing in comprehensive views of all sorts
and seeing what they had to contribute to public reason.
While Gutmann and Thompson built from his ideas — these were two
political theorists, I guess. I'm not sure actually. I don't know
what their affiliation is. But basically their point was the same,
that when bioethics commissioners or others are participating in
public debate about public policy they should use principles and
standards that they consider reasonable for everyone to accept and
yet be willing to discuss the terms that others propose. They should
seek significant points of convergence between their own understandings
and those of citizens who have more comprehensive stands that they
take on the basis of philosophical or religious views, views that
they might reject individually, that the council members might reject
individually. So mutual respect for persons and their positions
NBAC adopted this approach to deliver to decision-making in its stem cell report, and it claimed to find an area of common ground and shared values between liberals and conservatives regarding the moral significance of early embryos. Again, I'm not going to go into detail here. But basically what they concluded was that, if both sides were consistent, they would have to agree that it is permissible to carry out stem cell research using embryos remaining after the completion of IVF treatment in order to attempt to develop cures for serious diseases. It believed it had found an area of reasonable mutual agreement or consensus that was shared by those participating in this discussion.
In contrast, Leon Kass, who, when he chaired it, spoke on behalf of the President's Council fairly often, was very leery basing conclusions on some sort of consensus. He had the ear of the president apparently who, in his Executive Order establishing the Council, charged the commission with proceeding by offering a variety of views on a particular issue rather than to attempt to reach a single consensus position.
This was something that the Council attempted to follow to present various views, for instance, on the moral significance of early embryos. But the Council found that it really could not come to any agreement about that issue. Despite the fact that it was supposed to be biased in one direction, there really was tremendous variation of the views of members of the Council. And the majority of the Council in their cloning report embraced consensus. They had gotten so backlogged and unable to reach a conclusion that when they were recommending a four-year moratorium on research cloning they said they were doing this to allow for further democratic deliberation and for seeking a consensus about whether this research should proceed.
So it sounds like after being frustrated by being unable to reach any sort of common conclusion, they were willing to think of resorting to some of the deliberative procedures that could reach a reasoned conclusion based on consensus.
Basically, no one deliberation method has been used by all four councils. I won't even review them for you because I'm running out of time. I hope that you've picked up the general approach that they have taken.
One of the points I want to make in talking about future possibilities and future modes of functioning is that panels need to do more to communicate with public officials and the government persuasively. And I'll get to ways that that could be done as I go along. But perhaps I can bring this out by asking, why do we need a governmental commission to address these issues when there are private groups that can do so? We've seen in the UK that the Nuffield Council has done so.
The main difficulty in keeping this work, and there's a article of mine that's been distributed in which in my more naïve period of education in bioethics I advocated for the use of private groups. I no longer have that position having worked with the private group for four years. I can tell you about that if you want later on. But basically private groups are not responsible to any elected body, and the American public is the basic issue. They may be considered one more interest group pushing its own agenda as they emerge from behind closed doors.
National bioethics commissions have a sort of moral power that private ones may not, and this comes with their distinctive mandate to articulate an ethical perspective on issues raised by biomedical technologies on behalf of those to whom they're legally and morally responsible. They're legally responsible to the president; in certain instances, to certain agencies. Morally, they're also responsible to the public.
Their clout as national bodies puts them in a better position than private groups to obtain necessary relevant information and expertise, and their conclusions are considered to have great weight. This is not necessarily the case for private organizations.
The view that I have come to about the future of national commissions
is that their activist roles should be primary. A bioethics commission
that serves as a national seminar to provide publicly funded education
about the impact of our developing scientific powers on the human
condition has its place, but its place is secondary to the need
to address pressing ethical and public policy issues that affect
real living people in their everyday lives that are raised by some
of the new developments in the biomedical sciences.
The President's Council under Dr. Pellegrino, it seems to me, has been moving more in that direction in several of its recent efforts and I applaud that effort. There's still much work for commissions to do to address newly-developing issues. I could give you a list that I have to suggest, but I understand others are doing that later on.
But I think they need to avoid falling into the trap of becoming
another interest group pursuing their own objectives. The major
step that they can take to avoid this narrow fate is to engage in
greater consultation with the public. They could do so by developing
more fulsome public consultations as is done in the UK, done in
France — I served on the Canadian Stem Cell Oversight Committee.
They engage in public consultations whenever any changes are made
to any major provisions of such commissions — make greater use of
the Internet, organize meetings that engage members of the public
who have jobs or play roles that are relevant to the topic at issue,
[there are] various ways of doing this that I think national commissions
could do more to develop.
In the conclusion to its final report, "Summing Up,"
the President's Commission observed that in a pluralist society
a commission on bioethics can play an important role in engendering
and encouraging the process by which a vibrant and ever-developing
society reexamines, revives and reaffirms its system of value and
Such commissions are in existence to serve as vehicles for digging out, reconsidering, and revising current ways of thinking about how we should proceed with our uses of biomedical technology on behalf of all of us. This is a role I hope will be honored and protected in future administrations as it has been in the present and in the past. Thanks.
CHAIRMAN PELLEGRINO: Thank you, Dr. Cohen, for a very, very complete review of a complicated subject, and we appreciate your giving us that background for our further cogitations.
Our next speaker will be Dr. Mark Kuczewski, who is the Director of the Neiswanger Institute for Bioethics and Health Policy at Loyola University in Chicago.
DR. KUCZEWSKI: Thank you, Dr. Pellegrino and members of the Council. It's a pleasure and an honor to have this opportunity.
In my remarks today, I would like to speak to the question of the mission of a federal bioethics body. I wish to suggest that a federal bioethics body, whether commission or council, is at its most useful when it contributes to the development of a stable societal consensus on biomedical ethical issues.
I believe this assertion requires little direct argumentation for it. After all, who would not like consensus? But, I think that it must be supported by saying a bit about what I mean by "consensus" and the role consensus plays in our society.
In other words, the main obstacles that I believe my position faces are two. First, some may challenge an emphasis on consensus by arguing that fundamental value disputes prevent anything such as a genuine consensus from emerging. To seek consensus is to ask some persons to give up or compromise their important values. According to this objection, reaching consensus requires that some act disingenuously.
Second, I wish to characterize consensus not as mere agreement among the members of a federal bioethics body but as a template that may contribute to a stable societal consensus. By showing ways to respect seemingly contrary values, the federal bioethics council may offer a blueprint to assist us in living out our values. Because societal consensus is not the telos of this Council, I would like to briefly characterize how I understand societal consensus in order to show that it is also achievable.
Of course, in contrast to my position, many argue that an emphasis on consensus is misplaced and a bioethics commission does a better service by giving detailed outlines of all major positions on particular controversies. There is little doubt that such a commission may also perform a public service. So please understand that I do not assert that option to be wrong simpliciter. In fact, this mission which I understand to be that of the current Council certainly has a variety of virtues.
The Council, in its quest to accurately portray all relevant viewpoints has included members with views that have historically been artificially dismissed too easily because they are not common among academics. As a communitarian in the Aristotelian tradition, I have also been particularly encouraged by the restoration to prominence of considerations concerning what kind of life our choices regarding technology have fostered and how these choices affect our humanity. Such considerations are commonly passed over when seeking consensus.
So in no way do I wish to downplay the contributions of conceptions of bioethics commissions that differ from my own. Nevertheless, it is my considered belief that when a commission takes the step of putting forward a particular position, one that might advance consensus in our society, it probably contributes something of greater value than if it chooses to refrain from so doing.
We are a pluralistic and diverse society which has been noted many times today, and such an assertion may very well understate the case. There are moments when it can seem that each individual is his or her own idiosyncratic amalgam of beliefs, values, and judgments. In such a moment, consensus can seem a pipedream. But, as is the case in Western industrialized societies, we also have a realm of shared practices in which we live and interact together. For instance, health care is financed and delivered in ways that involve strong public sector support for a traditional private profession. And, there is a complex and constant ongoing negotiation about the expectations and standards that the public and profession have of each other.
While much of the rhetoric surrounding health care sounds individualistic,
e.g., the doctor-patient relationship, privacy, confidentiality,
et cetera, the medical enterprise seems to be generally located
within the "commons." There is no ideological leap in
saying that in common, we subsidize medicine, medical education,
and health insurance in many ways and for large swaths of our citizenry
in order to promote the health of our nation. Thus, we all have
a vested interest, not only in considering what kind of subsidies
and which services promote the general well-being of our people,
but also in arriving at solutions that make our health care institutions
the kind of trustworthy institutions in which we may live out the
dramas of birth, illness, and death. Biomedical ethics can be viewed
as a scholarly and practical discipline in which we try to find
morally acceptable ways to continue to live together in this shared
realm of medicine and health care.
It is the commonality of these very dramas that call for shared agreements and also make the possibility of consensus realistic. While we may hold a variety of world views, only the most dogmatic relativist would argue that living through the experiences of birth, illness, and death within the same institutions would not lead to some shared insight and the possibility of dialogue.
In living out life and death in the clinic, we move beyond being mere moral strangers. We develop some shared experience and a desire to make this realm humane for our intimates as well as those with whom we are less acquainted. We can aspire to, at minimum, become moral colleagues.
But what is a commission aiming at when it aims at consensus? The kind of consensus that has characterized some of the work of the various bioethics commissions is a combination of values and specific insights regarding practices. This has often been described as a balancing of principles and/or considerations. Consensus becomes possible because agreement is always possible if we can find ways of proceeding that respect the range of key values at stake.
Conversely, skepticism about consensus usually stems from believing that some parties hold values incompatible with those of others. We may not see ways of adjudicating between or among values and thereby lose faith in the possibility of genuine dialogue.
While this certainly may be true at some times and in some instances,
it is also evident that many people simultaneously hold these seemingly
incompatible values within their own world view and wish to respect
each. This has been most commonly advanced by bioethicists in terms
of the prima facie duties of the four principles of biomedical ethics
that we just heard about: autonomy, beneficence, non-maleficence,
and justice. But many bioethicists and ordinary citizens also simultaneously
value such seeming oppositions as choice and respecting life, freedom
to choose a good death and not killing, choosing to participate
in research but minimizing risk.
Approaches to particular problems that enable both sides of the opposition to be respected will be preferred by the public to having to choose between these values. Consensus might require that we cannot always have all of everything we want. But a stable consensus requires that we not be asked to give up the most important elements of each opposition.
To some extent, we can characterize the work of a bioethics commission as acting as a deliberative microcosm for a society. Its members seek to build a consensus among themselves that is potentially reproducible within the larger society.
Such a requirement has a variety of kinds of implications for the meaning and contours of consensus. In particular, we must characterize consensus so that we do not mistake the differences of opinion that can easily be found among people within a large nation with the lack of a shared way to live together, a consensus.
The work of a bioethics commission does not seek to end all debate in society. It aims to create a relatively stable consensus that is semi-performative in nature, that provides a core for shared living even as challenges and controversies arise around it, and that can seemingly disappear from public view at times. However, if well constructed in honoring a range of the core values of society, it emerges from these ongoing challenges and temporary eclipses and may undergo further development. Please indulge me for a moment in describing these characteristics a bit more.
First, consensus is sometimes said to be performative or semi-performative. By "performative," some mean that consensus exists at the moment that the points of consensus are recognized. However, that would seem too strong. After all, consensus is achieved because the elements of that consensus are implicit within the values and beliefs many in society hold.
Consensus is probably better characterized as semi-performative in that making the elements thematic and publicly pronouncing them reiterates and reinforces the consensus. This is a major reason why bioethics commissions should lay such a groundwork. While a consensus among commissioners is not a societal consensus, a carefully constructed consensus may help our society to discover and affirm such a consensus within itself.
Second, consensus does not bring an end to strong feelings among various groups, or end debate, discussion, or controversy. But it brings ways of proceeding that remain relatively stable in the face of challenges and controversies. For instance, the consensus on forgoing life-sustaining treatment faced a challenge during the Schiavo case but came through intact.
It has been challenged via referenda on assisted suicide but such challenges have achieved modest success. Clearly, consensus does not mean we all agree on how to treat patients in PVS or whether assisted suicide is morally illicit. Nevertheless, it has given us wide areas of agreement that allow us to die with dignity and respect within our shared institutions.
A bioethics commission faces a particular challenge in that the commissioners deliberate about the consensus, but the public must live it. Thus the commissioners will always be aiming to create constructs that they believe will resonate with people once they have an opportunity to live through situations in which the consensus holds sway.
This is an imprecise science as thought and being always have a tenuous relationship. Nevertheless, this lived application is the test of consensus. Each time a family makes decisions for a loved one who is near death, the consensus on forgoing life-sustaining treatment is tested and reinforced. The sense of its prescriptions is made evident.
Consensus can be hidden from sight when divorced from its experiential component. For instance, unusual cases such as that of Theresa Marie Schiavo may present a moral quandary for which the tenets of the consensus do not apply in obvious ways. Thus, bioethicists watched in amazement as the public divided for an extended period before coming back together in a consensus-affirming manner.
Cases in which the tenets of a consensus are not easily applied to the specific situation can be mistaken for situations in which the tenets of that consensus are facing serious challenge. We may confuse the inability of the public to apply its values and intuitions to a particular instance with the lack of shared values and intuitions.
Of course, consensus does not usually go straight from commission
to the clinic. The deliberations of such groups have sometimes laid
foundations for the reasoning of courts of law, professional societies,
and legislative and regulatory bodies. Thus the reasoning toward
a consensus must accord with the standards of such bodies, and it
must reflect the values of the citizenry who seldom think about
such matters until they are directly involved in relevant situations.
For them, consensus will mean "what I would think if I thought
about it within the appropriate set of experiences and contexts,"
a point I think I'm borrowing from Jonathan Moreno.
Thus, we have a picture of bioethics commissions as aiming to lay down ways to proceed in the health care enterprise that reflect the best within citizens, their cherished values and judgments. And, as noted, we can easily overlook such achievements in a society that constantly gives voice to differences of opinion.
Nevertheless, we have clearly seen such consensus develop regarding end-of-life decision-making and the ethics of research involving human subjects. It remains, perhaps for our discussion, whether such an implicit consensus has developed in regard to universal health insurance coverage and whose advancement could be assisted by a deliberative body.
Of course, I face the question of whether consensus is irrational.
As I stated at the outset, I believe that societal consensus on
bioethical issues and having a bioethics commission lay the groundwork
for this consensus is intrinsically desirable. I've tried to illustrate
that this kind of contribution and outcome is possible for I believe
it is doubt about the achievability of such outcomes that could
lead some to avoid taking this step.
Of course, as Dr. Cohen has pointed out in one of her background articles, we might also reject consensus as a goal or as a fact because it fails to accord with our view of rationality. However, this would be to privilege a view of rationality that is highly theoretical, academic, and based in the view of rationality conditioned by the biases of the Enlightenment.
The view I have been trying to advance follows the Aristotelian tradition in respecting the wisdom embodied in people of appropriate experience. Facts and values are closely related in a dialogical relationship rather than separated by an unbridgeable gulf. This view was advanced by Al Jonsen and Stephen Toulmin in the 1990s under the banner of casuistry. By examination of paradigmatic cases and increasingly distant approximations, Jonsen believed that bioethics commissions could devise a moral taxonomy to guide our society through its bioethical controversies. The case was paramount, reasoning about the case is secondary.
While this primacy of the particular may seem peculiar and irrational, one only need think about the prohibition of killing in the consensus on forgoing life-sustaining treatment. Our resistance to directly taking the life of patients can be supported by any of a large number of considerations. We do not have a single theoretical system that underpins the prohibition. Similarly, the question of assisted death sits on the periphery of the consensus because the case of the patient in uncontrollable pain and suffering still haunts us as we think about our individual futures. Nevertheless, directly taking the life of patients still clearly sits outside the consensus. There is little that is irrational about this situation. Why a theoretical underpinning rather than a number of "good reasons" would be needed to make this tenet rational is simply not clear.
As I have indicated, part of what makes this consensus a consensus is that it demonstrates its "livability" in practice. In some sense, it is "received" by the public. This is not too different from how moral teaching works in some organized religious institutions such as the Roman Catholic Church. While recent years have seen an emphasis on the formal teaching documents set forth by the hierarchy known as the magisterium, genuine teaching must reflect the "sense of the faithful," i.e., be received by the faithful. If teaching is set forth that is too discontinuous with the tradition and not adaptable to the circumstances of the varied lives of the faithful, the teaching set forth will fall into disuse rather than become a part of the living tradition.
Jonsen and Toulmin acknowledge this narrative element of the casuistry of public bioethics but their rhetoric can, at times, sound as if it is a narrow or naïve realism. Nevertheless, bioethics integrates moral perceptions and intuitions with reflection on values in an ongoing feedback loop. So understood, the role of a bioethics council is to be a key contributor to the social construction of a shared narrative through its reflections and recommendations.
However, as with the magisterial role in my example, such reflections can fail to be received and to bear fruit. In other words, there is always the possibility of error. Error is not a mere failure of apprehending facts or reasoning logically, but missing the mark of devising recommendations that appropriately incorporate the values and needs of those affected by the deliberations.
This line of reasoning entails that among the important virtues for any bioethics commission will be courage and humility. Commissioners must have the courage to put forward their creative attempts to honor and balance the values and considered judgments of the citizenry. This courage will be reinforced by the humility of knowing that the deliberations of bioethics experts are just one part of the process and a part that might ultimately be shown to have been mistaken.
One of the implications of this approach to the deliberations of an ethics commission is that it works best in situations in which the public has some access to experiential content relevant to the issue. That is, if stable societal consensus is best produced by a process of deliberation and recommendations followed by the public encountering the framework in its clinical experience and reiterating, refining, or rejecting it, issues that make it difficult for the public to ground its reception or rejection in experience will create difficulty in anchoring the stability of a consensus.
Thus, it is easily understandable why the most stable consenses have been produced in regard to forgoing life-sustaining treatment and human subjects research. These are areas in which thousands if not millions of citizens have relevant experiences each year. Thus, these consenses are activated, reiterated, and reaffirmed each day. And, it explains why a case like that of Terri Schiavo can seem to threaten a consensus but never actually place it in jeopardy.
The specifics of a case can be so far removed from the ordinary ways in which people encounter it that it may not even be obvious to them that the principles and values that these citizens have relied on are at issue. But, this particular case continued until a clearly cherished value was threatened and the public reacted.
This would tend to make issues such as access to and affordability of health insurance and methods of procurement of organs for transplantation good candidates for the consideration of a bioethics commission and development of a societal consensus. Possibly, health disparities, the treatment/enhancement distinction, and matters of provider conscience, might seem to hold some potential in this regard.
An issue such as the funding of embryonic stem cell research would seem the least likely among these issues to be a candidate for a stable societal consensus. With this issue, it's not clear what would constitute relevant moral experiences and it would seem that the debate is mediated by other issues such as that of in vitro fertilization or abortion.
The more the questions are seen through the lens of in vitro fertilization and the discarding of "leftover" embryos, the more the public is likely to coalesce in support of research. The more the question is viewed through the lens of abortion, the less likely it is to command widespread support.
The former case seems to be winning in the court of public opinion. However, there are considerations that suggest it is difficult to found a consensus on such an analogy including that the analogy will not prove stable if the discarded embryos are not sufficient for the purposes involved.
In closing, I would just like to say a couple of words about the future of commissions and commissioners. There is no sure formula for selecting commissioners. But my reasoning to this point suggests that a variety of perspectives is better than fewer perspectives. In particular, it is important to have perspectives of people whose implicit concept of rationality is more practical than theoretical. Thus academics should probably be more than balanced by non-academics.
Similarly, it is important to have a variety of views along the spectrum represented. While this may seem obvious, it is easy for academics to devalue viewpoints from other parts of the spectrum as irrational and dismiss them from consideration. As I mentioned, it has been a virtue of the current Council to have broadened the spectrum of views beyond the typical viewpoints common among academics.
The goal of contributing to a societal consensus is probably best facilitated by having people of strong, but not necessarily inflexible, views. That is, societal consensus is best achieved by finding ways to honor the core value or values or most cogent kernel of truth in each of the viewpoints along the spectrum. Commissioners will not serve the nation well if they do not hold to such core values. But consensus is ruled out a priori if commissioners are wedded to the idea that anything but agreeing with an uncompromising systematic development of one particular position can be the only reasonable and acceptable outcome.
In making these modest suggestions, I have taken seriously the Aristotelian dictum that the end of practical wisdom is not solely "to know," but also "to do." And I have tried to indicate that, in fact, we must take seriously that we do not always truly know in advance of doing. There is a complex relationship between these elements.
Of course, perhaps such an insight has been assimilated by the biomedical community and bioethics is more mainstream than we have recognized. For instance, in this decade, the Institute of Medicine of the National Academy of Sciences has published important and influential reports on insuring the uninsured, health disparities, and increasing the number of organs available for transplantation. Each report has significant ethical components and some, albeit few, bioethicists were among the authors. So perhaps it is possible that bioethics is being mainstreamed with less work left to specialized commissions.
Thus, I think part of our challenge might be to ask what distinctive contribution a commission that is per se a bioethics commission might make if we believe that practical wisdom is actually practical.
CHAIRMAN PELLEGRINO: Thank you very much, Mark. We appreciate your presentation. Thank you very much for taking us through a careful consideration of one of the major issues that I see.
I'm going to ask Carl Schneider to be the Council member to open the discussion, and then we'll throw the discussion open to all the other members.
DR. SCHNEIDER: I want to add my thanks to Dr. Pellegrino for unusually intelligent and helpful presentations, and I with some embarrassment cannot prevent myself from saying that Dr. Cohen's presentation shows why we are so proud of the graduates of the University of Michigan Law School.
DR. COHEN: I might add that graduates of the University of Michigan Law School are very proud of Dr. Schneider.
DR. SCHNEIDER: Oh, dear. What I want to do is to build mostly on what Dr. Cohen was saying. I've already expressed some discomfort about the question of what kinds of consequences these commissions actually have and talked about the post hoc ergo proctor hoc error of believing that just because something happens after something else that the prior event caused the subsequent event.
But what I want to do now is to talk about these commissions insofar as they are attempting to affect public policy because public policy is what lawyers worry about and I'm a lawyer. I want, however, to make it clear that I'm not going to talk about the work of this Council partly because that seems otiose and partly because I think this Council has been quite different from a lot of its predecessors. And I've already explained the reasons I think that our Council is different from many of its predecessors before, so I won't bore you with a repetition of it.
I have often thought that the law of bioethics is the law of failure,
that the law of bioethics has repeatedly failed to achieve the goals
which it is set out to achieve. And my question is whether a commission
of accomplished amateurs, assisted by a staff that is expert, but,
(necessarily), experts who are generalists, can make a
useful contribution to writing public policy. And I want to build
on what Dr. Cohen was saying by taking as my example the IRB system
that has been a major focus of both the presidential commission
reports and numerous other private and public kinds of reports.
There really has come to be something that I call "big ethics." There are now so many councils and commissions and people who make their living by selling ethical expertise and advice or by enforcing what are taken to be ethical rules that I think thinking of it in industrial terms is quite appropriate.
If one looks at the history of the commissions that deal with human subject research, I think what one sees is a consistent failure to ask the right questions and to bring the right kind of information to bear. The commissions — and I have to generalize unspeakably, but I must. The commissions have never thought critically about the definition of human subject research. As a result, human subject research encompasses biomedical research and social science research and treats them virtually identically even though they are radically different. And no prolonged considered discussion of this comes in any report that I have been able to find, and I have read these reports. Livelier, more graceful writing would be gratefully received by the consumers of these reports.
The commissions have never seriously asked how dangerous human subject research actually is. They have never asked whether it is dangerous enough to merit any kind of regulation at all. They have simply recited the names of scandals and left it at that. A scandal is not an argument for regulation. A scandal raises the question whether regulation is needed and invites an inquiry into that subject. The recitation of scandals, in fact, serves to prevent discussion of whether or not regulation is actually needed.
The commissions have never asked what kinds of costs the regulations that they propose of human subject research might incur, even though that is surely one of the two or three most elementary questions to ask. The administrative costs of these systems have grown and grown and grown, but the commissions do not look into those costs partly because the costs are concealed by the fact that they don't appear on budget lines. The real costs are in the time of the IRB members and in the time of the researchers who are extremely expensive people. But they do not work on a budget and those costs have been ignored.
What has never been considered in any way that I have ever been able to find is the cost of stopping research. The IRB system deters, delays, and denies research. If you believe that human subject research saves lives, prevents and cures illnesses, and ameliorates social distress, then you have to believe that setting up a major block in the way of human subject research will have consequences in lives. It may be that is a consequence that is well worth paying. But to ignore it, to have commission after commission after commission ignore it seems to me to be a very poor testimonial to the commissions.
The IRB system has done enormous damage to the infrastructure of research. Without any genuine consideration, students were lumped in along with everybody else when it came to regulating human subject research. As a result, it is very difficult to get many kinds of training for graduate students. It is very difficult for young people who are not tenured to take on human subject research projects in many kinds of areas. And even old people like me say that it is not worth the trouble of dealing with IRBs when you have so many other things that you could usefully do with your life. And I have given up human subject research myself exactly for these sorts of reasons.
The IRB system is a system of censorship. It tells people, "You may ask these questions and may not ask those questions." It specifies the exact language in which you have to talk to people. Remember that social science research is the other half of human subject research. So we're talking about my ability as a citizen to talk with my congressman if I'm doing it for research purposes.
There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both. The commissions have never seriously asked, "What are the regulatory choices available to us if we do conclude that human subject research is dangerous and needs to be regulated?"
This is particularly bizarre because the kind of regulatory choice made is one of the weirdest regulatory choices available, which is prior licensing of each single research event. Doctors do not have to have each one of their decisions licensed in advance. You license the doctor, not the decision. Journalists don't have to be licensed at all, even though they ask exactly the same questions the social science researchers do.
The commissions have repeatedly bemoaned the fact that IRBs swim in paperwork, that they impose huge amounts of paperwork on other people. The commissions have repeatedly bemoaned the fact that IRB members spend endless amounts of time fiddling in trivial ways with informed consent forms, but they have never — they, the commissions — have never asked whether that might possibly be because of the incentive structure that is inherent in the IRB system.
When they were thinking about their regulatory choices, they never asked whether good decisions were likely to be made by the people who wind up on IRBs. That is a problem partly because IRBs are now responsible for making such a very wide range of decisions that it is impossible for any group of five people or so to be truly knowledgeable about it. In addition, the work has become so unpleasant that senior people will no longer serve on them. If you're a medical school dean, who are you going to ask to serve on your IRB? Your best researcher?
Furthermore, in thinking about the regulatory choices available to them, these national commissions have never asked whether you make a good decision and whether you can be fair to the people about whom you're making a decision if you have an agency for making these decisions, a governmental agency for making these decisions, that does not obey a single one of the precepts of the rule of due process — not a single one. The commissions have believed that what they were doing, if they were doing anything, was to supply researchers with ethical principles to use.
The Belmont Report is repeatedly described by people at OHRP, for example, as, I kid you not, "the best governmental report ever issued," "the most influential government report ever issued." If we look at the Belmont Report as a source of guidance to the regulators and the regulatees, it is — I'm struggling to control myself. It breaches a system of ethics that are impoverished, that are incoherent, that are simple-minded, and that are befuddling.
Read the Belmont Report with an eye to figuring out what it means if you are a regulator and you will be a jumble of vague ideas which cannot be given regulatory meaning. And if you see how these ideas are taken by governmental agencies and used — a colleague of mine and I recently took the NIH test that will determine whether or not we were ethical enough to be allowed to do research. To answer the test in the way designed to get you 100 percent, we had to lie. We had repeatedly to say things we didn't believe because of the kindergarten ethics that researchers are now taught.
So the question is, are we not under notice to inquire whether there isn't something wrong with a system of commissions that gives rise to and continues to approve of a system with so many questions? And I think that the reasons to be worried are two. First, you cannot make good public policy if you don't know anything. And the empirical basis for thinking about these questions intelligently is absent. The commissions repeatedly say, "We don't know anything about how dangerous research is. We don't know how it's actually regulated. We don't know anything. But we know that we have to protect human subjects, so let's do it as thoroughly as we can."
You can't study human subject research regulation because to do that you have to get the permission of the IRB. And if you actually get their permission to study them, you have to realize that if you offend them, they believe themselves entitled to say, "A failure to show respect for us is a failure to show respect for ethics, and you are therefore unqualified for doing any more human subject research."
The second thing that you would need in order to make good public policy is some understanding of regulatory choices and regulations. These commissions have repeatedly failed to discuss regulatory choices in a way that leads me to wonder whether they actually realize that when you make laws, you make choices about institutions and methods that are extremely consequential. I think what you tend to get from almost any commission of this sort is a reflection of somebody's conventional wisdom. I think that, if there is a problem in mainstream bioethics today, it is that it is all conventional wisdom and very little dissent.
Do we need another agency that reflects the conventional wisdom in bioethics today?
CHAIRMAN PELLEGRINO: Thank you, Carl. Further comments from the Council members or response from any of our visitors? Gil, did I see you make a motion?
PROF. MEILAENDER: You didn't see me make a motion, though I was about to do that. So you anticipated —
CHAIRMAN PELLEGRINO: Well, I'm getting pretty good at predicting.
PROF. MEILAENDER: You can probably even predict what the question is about. This is for Prof. Kuczewski. Am I pronouncing your name correctly? I just want to think about your commitment to consensus or to what I would think if I thought about it, which is a formulation sort of like the formulation of that great theorist of consensus, Rousseau, that the general will is, even though I opposed it, is what I do actually believe if you force me to be free.
You're looking for something that sort of both sides can respect
each other, or you said "a shared way of living together."
You had various formulations. I thought we had a way of accomplishing
that. We call it votes. You take a vote. Some people are in a majority.
Other people are in a minority. And you, if you're in the minority,
you live for another day when maybe you're persuading more people.
That's a way of respecting other people, and it's a shared way of
living together. It's precisely not a search for consensus. And
I am just wondering sort of what you have against voting on these
DR. KUCZEWSKI: Nothing. I like the democratic process for many purposes, and clearly the democratic process lays some framework for how these matters get decided and whether there are commissions and so forth. So clearly that kind of thing is true.
But there is a level of practicality at which voting isn't a way
to get at something, a way to live. For instance, I mentioned the
Schiavo case several times. The public reacted most strongly
when elected officials decided to put their hand in that because
that seems to be one of the tenets of the consensus, forgoing life-sustaining
treatment, whether it's implicit or explicit. But these things need
to be decided as best they can by families and patients and doctors
and when they can't, they can go to the court of law and they can
argue their cases, but that the public should stay as far as possible
out of these kinds of decisions.
And so there's a level of this at which it doesn't work well for
us to be necessarily voting on things. But, again, the votes we
cast will frame some of the values that are in play in these issues
and sometimes a referendum in a state will decide an issue, such
as assisted suicide on the West Coast.
So there is a place for it, but I doubt on the everyday level for most of these issues we can get down to that level by voting, such as the kinds of concerns Prof. Schneider had about the IRB system. I don't know that those would be effectively tackled through voting.
PROF. MEILAENDER: Just quickly, I thought we were talking about national bioethics bodies and how they might best work.
DR. KUCZEWSKI: Right. But what national bioethics bodies are doing is laying the groundwork for these lower levels of decision.
CHAIRMAN PELLEGRINO: Thank you. I have Dr. Rowley, Dr. Gómez-Lobo, and Diana —
PROF. SCHAUB: Okay.
I want to pile on. In other words, you presented an ideal council
as perhaps a microcosm of public manipulation, and I think what
Gil was maybe saying is, isn't that in a way to displace the political
process and to sort of shift the locus of decision-making? You spoke
of perhaps the hope that councils can arrive at policies that wouldn't
even be seen by the public and I guess it would be a mark of their
I guess I would rather see a council which provides materials which are really preparatory to public deliberation, so that the ideal is really to inform and debate. And councils can do that by clarifying positions of the parties because the real political process only works through parties and partisanship so that a council can clarify the parties. And beyond that, a council could try to see further than the parties themselves see or bring forward considerations that the parties perhaps have not thought of, but that when it comes down to it, these things will be decided and ought to be decided by majority rule, which is something different than consensus.
CHAIRMAN PELLEGRINO: Did you want to respond briefly?
DR. KUCZEWSKI: Well, I'll wait for more questions first. If we're going to take more questions first, I'll wait.
CHAIRMAN PELLEGRINO: Okay. Janet?
DR. ROWLEY: Well,
as people have spoken, I have more comments and questions. With
regard to the vote, I think it's very informative reading. Dr. Cohen's
analysis of the Council is to point out that the majority on this
Council regarding stem cell research changed and that there were
two, at different times, but very close in chronological time to
one another. There were two different majorities depending on the
first vote and the second vote. So a vote partly depends on the
question and how it's framed. So I think that that's not necessarily
such a sacrosanct goal.
I also think that, in fact, a part of what has been presented,
both earlier as well as today, is that the councils are contributing
to public policy, not setting it, but we are, in fact, part of a
larger discussion. And certainly one doesn't look to parties to
present this because within both parties there are both — to take
one example, pro-life and pro-choice, so that a party isn't again
the effective way to do this. And I think we have to recognize that.
And, finally, as a person whose research has been directly affected by IRB decisions, I have to say that much of what Carl said is right on. And I think I don't come at it from anything but the user's point of view or the affected point of view. But when one is prevented from using tissue that could lead to — well, I'm self-serving here — but what I consider important research of somebody who is dead, but whose tissues could lead to important medical information and the inability to have access — I have the tissue but I can't use it — that leads to enormous frustration.
CHAIRMAN PELLEGRINO: Thank you, Janet. Just so you all know where we're going and what the chronological problem — first, I want to ask Cynthia to respond and then Alphonse Gómez-Lobo, Rebecca Dresser, Paul McHugh, Bill Hurlbut, and Peter Lawler, and we do have some need for lunch. As a clinician, I want to be sure that you're fed and ready for the afternoon. So, therefore, let's go quickly. I'll stop talking.
PROF. LAWLER: Is there any way our two guests could stay — the list is so long — they could stay around and we could start off this afternoon with them?
CHAIRMAN PELLEGRINO: Surely.
DR. COHEN: I'm going to have to excuse myself.
CHAIRMAN PELLEGRINO: Let's go along first. I'll make the decision when it comes. Okay, Peter?
PROF. LAWLER: I'll make the decision — okay. I can go along with that.
CHAIRMAN PELLEGRINO: That was a little bit devious.
DR. COHEN: I'm staying a little longer than I had anticipated right now. I have a family member in the hospital, so I'm going to have to excuse myself.
But I must say I had Prof. Schneider for two elective courses,
one of which was a seminar that went on for hours — I've never seen
him so mad. Human subject research is not a field that I've looked
into and obviously you have much more extensively than I have. I've
looked at it from the other end, not from the point of view of sort
of vague generalities that you may have found in presidential commission
recommendations, but as a member of panels at the NIH. And I have
finally said, "I will not be on your panels anymore,"
but for different reasons from yours.
I feel that patients are being abused who are in some of these
research protocols, and they're confidential so I can't really go
into detail, except to say in one, patients were being exposed to
a procedure that is risky as controls— in fact, that was true in
both of them — as controls, and the study had sufficient evidence
in my mind to show that the whole thing should be stopped. They
had the answers that they needed. I couldn't get them to stop it.
I wrote to the Director of the Institute. He refused to stop it.
I resigned from the committee, got a colleague on who's a lawyer
and more forceful, perhaps, than I am. He got it stopped within
a month. So I'm concerned about abuse of people who are patients
and controls at the same time.
I resigned from another committee for the same reason. I could
not get them to do studies that did not involve patients who had
serious conditions who were being used as controls and having certain
procedures done on them that were highly risky. And I had an alternative
way for them to do the study. They totally rejected it.
So I've given up from that point of view, not because I think the regs are insufficient or totally unusable, but because whatever regs there are, they're not protecting patients in my mind. I think you have a good point on the need to separate social scientific research from biomedical research. They are rather different kinds of research. I think your point is well-taken there.
But I'm going to leave the rest up to Rebecca because she's the authority on this.
CHAIRMAN PELLEGRINO: Peter, to get you off the hook, I was playing games. Obviously, Cynthia and Mark Kuczewski are invited to stay when we invite them for the whole session as much as they want. I just wanted to be sure they were fed while they were here. That's my Latin background. Lunch takes precedent over everything. Dr. Gómez-Lobo?
DR. GÓMEZ-LOBO: I think I can formulate my question in the afternoon to Dr. Eric Meslin, so I will pass.
CHAIRMAN PELLEGRINO: Dr. Cohen is leaving on her own volition, Peter.
Dr. Gómez-Lobo, you are next. And you want to go for the afternoon, right? I want to be sure that's what you want.
DR. GÓMEZ-LOBO: Yes. I'm passing now, and I'd like to formulate the question in the afternoon.
CHAIRMAN PELLEGRINO: All right. Rebecca Dresser next.
PROF. DRESSER: Well, I can pass, too. My question could be deferred. It's a general question that will be addressed in the afternoon, too, so I can wait.
CHAIRMAN PELLEGRINO: Okay. I
just want to indicate my chairman prerogative allows me to extend
us until 1:00 o'clock for lunch, so I don't want to inhibit you.
I just gave the names in order. Do you still want to postpone it?
There may not be time in the afternoon if we keep postponing it.
PROF. DRESSER: That's true. All right.
Well, I wanted to make another comment about the problem of policy advice. In the US we tend to have these different commissions at different times because they tend to be linked to different administrations unlike in France and even Nuffield, which goes on.
It seems to me, if you look back, there are different councils and commissions for different times and different appropriate roles. So in certain cases policy advice is more appropriate than in other cases. It depends on what you're asked to do. It also depends on the topic. So topics such as the definition of death, end-of-life issues, those are matters of state law. The federal government can say little about those areas, and so a federal bioethics group can certainly put information and thought out there, but there is no direct connection.
Similarly, with a presidentially-appointed group, there's no direct
connection to Congress and Congress makes the laws. Even if you're
talking about regulations, any documents by groups, such as even
the National Commission, then went to HEW and then were put into
proposals by officials there and then were put out for a notice
and comment, and then became final regulations. So the connection
is far from direct in any of these cases.
End-of-life, those issues, have been played out a lot in the courts. So the influence we can have on courts is, again, indirect.
So I guess that has influenced me in my view that a frequent and probably appropriately deferential role for these groups is to put out some documents that try to state a thoughtful discussion, deliberation, and including highlighting differences and then let them be taken up by the appropriate people. I don't think we are qualified or asked to form specific policy, and I don't think we should.
CHAIRMAN PELLEGRINO: Thank you, Rebecca. Mark, I have three Council members who wish to comment. I would like to give them the opportunity and then give you the opportunity for closing comment on any one that you wish. So I have in this order Paul McHugh, Dr. Hurlbut, and Peter Lawler.
DR. McHUGH: I can't quite put this in relationship to a question, but it goes along with what my fellow Council members have been asking in relationship to both of these interesting and important contributions to our discernment, both of previous councils and of the present Council. I see myself warned by Prof. Schneider that I shouldn't speak about the present Council. But it's the only one I really understand at all, Carl, so I'm stuck. I have to speak a little bit about my experience here.
And the major point that I want to make is that this Council was different, not only in its constitution, but in the way it went about its business. And I felt that the way it went about its business was most useful to someone like myself.
Leon, at the beginning, told us all that what we were going to do was, in fact, a process of dealing with problematic matters by really studying them at the beginning from the best experts in science we could find. That was a most remarkable and distinct approach because it got us all up to speed. We heard from the best people in the world about what was going on, for example, in the realm of cell biology, embryology, and the like, and we could question them about the science and develop from then on a sort of sense of the meaning that we saw in them.
It was an approach, not simply to inform the world about what questions that they had about things like the end of life, but to consider a technique, a new technique, and consider it from the point of view of what, if any, harm, what it might threaten to ourselves. And so we then found ourselves ready to have a conversation that was very far-reaching. And the comment from Dr. Cohen 's interesting program that somehow or another at the end we decided to seek consensus outside in the so-called democratic process, I didn't see it that way at all.
I saw it rather that we had come to a point in the contemporary knowledge of science where there were interesting issues to still be debated that probably needed further discussion, not only discussion in the public media, but also in the laboratories to discern really what was at stake with these matters. And the democratic process was working itself out in a most appropriate way.
I want to be clear, therefore, that I think that we did a remarkable
job in not seeking internal consensus but by spurring public discussion
in a most informed way and the fact that our Council was, during
at least that episode, constantly in the newspapers and [people
were] constantly wondering about what we were saying and why were
saying it, [and we] did a good service to our country at the time,
I suppose I'm discouraged by the fact that I'm not sure that conversation has carried itself terribly much further, even at the same time that another approach to bioethics has produced the Belmont Report, which I agree with you is kindergarten ethics. So it can be discouraging.
CHAIRMAN PELLEGRINO: Dr. Hurlbut?
DR. HURLBUT: I'll just defer until the afternoon.
CHAIRMAN PELLEGRINO: Thank you very much. Peter Lawler?
PROF. LAWLER: I'm
not going to go through all the details coming out against consensus
through kindergarten ethics. If you look at this embryo thing, for
example — let's say Clinton's Commission — if both sides
really thought about it in a Rawlsian way, they would come to this
consensus, that if you really think about what you're saying, you'd
be all in favor of killing IVF leftover embryos for research. But
no one's ever bought that.
So the actual embryo policy, three stages, Bush compromises with
his restriction on research. Our Council compromises — I wasn't
here then, but I read about it. Our Council compromises with the
moratorium. And Obama breaks the spirit of compromise, but for consensus.
He just says "the majority is on my side and that's what I'm
going to do." There's no consensus in there.
CHAIRMAN PELLEGRINO: Any further comment? Alfonso, do you still want yours for the afternoon? Thank you.
DR. KUCZEWSKI: I'll be very brief. But thank you for this last opportunity.
Part of what I think that the difference between people who like to put forward recommendations to try to model a consensus and those who think of it as preparatory and just outlining positions is whether you think there's somewhere else that that deliberation then happens once you do it.
And as a philosopher, I like the model of a New England town hall meeting where everybody decides everything and then we could all deliberate and these reports would help us do that. But most people would find that extremely cumbersome, and it doesn't happen. And so for the most part, as Prof. Whittall said this morning, the public education part is actually quite hard when you're talking about common people because, where do you ever go? And then once you educate them, they say, "Well, what do I do about it?" Well, the answer is, "Not much. You don't have much direct say."
And so I have tried to argue that, in fact, rather than be preparatory, it's better if the deliberative work gets done here and aims it at a recommendation that one believes can garner support once people have to live with it.
And the only real danger though to the current model, I think,
is the false impression that nobody could ever agree on anything
and because we're just outlining things. Well, don't sometimes conclusions
hit you in the face when you outline a couple of positions?
And as an ethicist I think there are occasions when they just call
us to put those forward. The fact of so many people with no health
insurance in this country, I think it's very clear when you look
at the facts of this, this is an injustice. This calls for something
to be done. Ethicists, I think, should have a hard time not saying
that in that, in fact, the public seems to be running ahead of us
with the consensus in that we've never really contributed to articulating
that I think is not a good thing.
And I think they miss the creativity we could have employed in putting forward some thoughts and deliberations on that. So I feel that there is a contribution to be made that we should sometimes not shy away from. Thank you.
CHAIRMAN PELLEGRINO: Thank you very much, Mark. We will return at 2:00, and we have a heavy afternoon so please be on time.
SESSION 3: NATIONAL ETHICS COMMISSIONS: FUTURE AGENDAS
CHAIRMAN PELLEGRINO: Thank you. I think we're ready to go. A few more coming in. Despite all that discussion about lunch before lunch, we really did not have a big lunch. So I want to assure you that being late had to do with processing our payment, not overeating.
This afternoon we will turn to our next topic, which is that of national ethics commissions' future agendas, looking at how these kinds of organizations we've been looking at would look or should look or might look in the future.
I'll repeat for our two speakers, we don't give long curriculum vitae. That does in no way demean your extensive record of accomplishment, but only to save a little bit of time because you'll find that this council is eager to ask questions. But we will simply give you a title, so please bear with us. The first speaker this afternoon is Dr. Mark Frankel, who is the Director of Scientific Freedom Responsibility and Law program of the American Association for the Advancement of Science. Dr. Frankel.
DR. FRANKEL: I'm here. Can I be heard?
CHAIRMAN PELLEGRINO: Yes, we can hear you here. How about the rest of you?
DR. FRANKEL: No, they raised their hands. It's nice to have agreement at the beginning before I've said anything. Dr. Pellegrino, thank you.
CHAIRMAN PELLEGRINO: Thank you.
DR. FRANKEL: It is both scintillating and somewhat daunting to be part of this day given the breadth of issues that you have been and will continue to discuss, but I do want to thank you and the council and the staff for giving me the opportunity to share some of my thoughts regarding looking forward and what future commissions might want to take a look at when they develop their agendas.
I have a couple of preliminary comments. I want to make clear that
my remarks today are in no way representative of an official or
unofficial position of AAAS. They're simply my thoughts on the issues.
And I do want to acknowledge the research assistance of a couple
of my staff who helped me put this together and who happen to be
in the audience. I also want to give Professor Schneider a heads-up.
There is one place in my talk when I use the acronym IRB.
PROF. SCHNEIDER: Abandon all hope.
DR. FRANKEL: While I think science and engineering
are alive and well, there's a lot of creativity going on out there,
a lot of interesting things being done, all of which probably have
some ethical issues that we could think about and consider, but
my time is limited with you, so I've chosen four that I would like
to suggest are worth considering in terms of bioethics.
And I'll — if I get this right — we'll begin — that's a play on words, by the way — with personalized medicine. William Osler, who is often described as the father of modern medicine, wrote in 1892 that if it were not for the great variability among individuals, medicine might as well be a science, not an art. And it may be that medicine will soon approach that time when it can take on successfully the complexity of variability and enter a new era of science-driven medical practice.
I suspect that many of you have encountered the term "personalized medicine." This is a slide, I think, which really gets to the heart of it. And I don't want to be terribly technical about it, but the idea behind personalized medicine is to use the kind of variability referred to by Dr. Osler to develop new treatments and to identify subgroups of patients who are likely to benefit from them the most so that the one-size-fits-all medicine is likely to be tailored to individual patients, taking advantage, if you will, of those pesky variations.
And although doctors have long incorporated personal features and traits and characteristics of individuals, personalized medicine in the contemporary form holds the possibility of perhaps changing medicine dramatically by developing more powerful diagnostic techniques to go along with the knowledge that we gain about our genetic and neurological makeup.
The expectation is, for example, that it will lead to more successful therapies by targeting the right treatments to the right people and that it will also improve patient's safety by selecting drugs in their proper dosages to reduce adverse side effects, as well as improve the participation of clinical trial participants. Now, all of this according to its proponents is going to also lower the cost of health care.
Well, whether it does any or all of those things remains to be seen, but I do think it's very promising and based on my conversations with people and reading in the field and our own project, the AAAS, dealing with personalized medicine, I think it's worth exploring. It's beginning to emerge, and it's clear that there are a lot of scientists in collaboration with the medical profession who are heading in that direction.
Let me give you a few examples of things that are being done now that might come under the rubric of personalized medicine. Patients diagnosed with early stage invasive breast cancer can now be tested for the likelihood of recurrence as well as how well they will respond to chemotherapy. Very recently patients diagnosed with advanced colon cancer were advised by the American Society of Clinical Oncology to get a genetic test before undergoing two of the leading treatments. The advice is based on the discovery that the two drugs won't work for four in ten people and those patients can be identified through the test.
Now, what that information will do to the psyche of those patients is something that we need to think about, both in ethical and policy terms, but the science is moving along, if not gradually, certainly in drips here and drops there. Based on genome-wide association studies, which are studies which involve gathering massive amounts of data to compare people who have the genetic components of people who have a disease against those who don't, it's rarely a week that goes by that you don't see something in the literature, perhaps even in the newspaper, that scientists have been able to show an association between this gene and this disease. And you can almost fill in the blank as to what disease it might be.
In fact, last year researchers found that there were nine genes linked to Type 2 diabetes. Now, the difficulty with all of this is twofold. One, we're not sure what to do with the information; and, two, we're really not quite sure how to interpret it in the context of health, not only because genes will vary, if you will, in their penetration — and, in fact, the effect that genes have are likely to be of an interplay or an interaction between various genes — it's also missing any connection to lifestyle and environment.
But these limitations, I don't think, should obscure the very real possibilities that lie ahead. And neither should they obscure the very critical role that information technology is playing in the push towards personalized medicine. We will not have personalized medicine if that is the goal of the country without very powerful IT, information technology, that can take, collect, store, analyze, et cetera large amounts of information.
And while these kinds of studies the genome-wide association studies are building databases and trying to draw connections between genes and diseases or between genes and responsiveness to certain treatments, some scientists are actually developing approaches that try to combine this valuable genetic information, if you will, with patients' electronic health records.
This is a slide of a project funded in part by NIH, basically at Vanderbilt University, which is an attempt to see whether or not data collected from electronic health records where names are not identifiable can be matched to the genetic data that is being collected. Potentially, of course, if we're able to link genetic data with electronic health records of people, we'll probably be able to zone in more on the diseases and the possible treatments than we can do now.
And then there's one additional role for IT and personalized medicine that I want to bring to your attention, and that is the emergence of technology companies, like Google and Microsoft, who are beginning to look at the possibility of playing a very critical role, if you will, in holding on to patient information, organizing it in such a way that patients, if you will, will want to see all of their data available in one place and readily accessible to them, but not accessible to anybody else without their permission.
So you have something called Microsoft Health Vault, one of the companies involved. The business plan behind all of this, of course, is that Microsoft will be able to claim that it is able to provide to patients all they need to know about all of their health information going back to the extent that they have access to it, as well as in the future. Whenever they have a drug test, whenever they have a scan of some sort — all of this information could be sent to their personal vault at Microsoft. And the idea, of course, is that then others will pay to have access to that information with, of course, the patient's permission.
So clearly what you see is a blending, if you will, with powerful information technology and knowledge about genetics, neurology, et cetera, to the point where personalized medicine may well someday be a reality and it seems to me it's worth taking a look at some of the ethical issues that arise in that context.
Let me begin with a point that I just made, and that is the notion that commercial enterprises will begin to enter the picture, will become major health care players, if you will, to the extent that they do become major repositories of information, information that would be very valuable to use for research purposes.
The question we might ask from both an ethical point of view and as a researcher is what are the responsibilities of those entities, if you will, to make that information available to researchers and under what conditions.
Another issue that comes to the fore is this notion of linking these large genetic databases to personal health records. It sounds like a good idea, but it raises lots of questions about the integrity of the data that is collected. If decisions are going to be made on the basis of this information, then we'd like the data to be as solid as possible. But as you well know, I'm sure, simply as patients, the way physicians manage the health records of patients differs from physician to physician and certainly in broader scale from the point of state to state, health care entity to health care entity, so forth and so on.
They may have this difference because there are real and genuine differences in their interpretation of their diagnosis of the patient or they may well be playing the insurance game and providing a diagnostic code that may just not be right or another physician would apply, but in this case, the first physician is using a different code simply because of insurance purposes.
So surely there's some sort of ethical responsibility here to ensure as much as possible that that data is, indeed, as accurate as possible in order to use it for research purposes, but whose responsibility it is to ensure the accuracy and how that can be discharged are really questions that we haven't begun to pose.
There are issues also for clinical trials with personalized medicine. Pharmaceutical companies will indeed apply the principles of personalized medicine selecting research subjects and they will group these subjects perhaps because of genotype or some sort of neuro bio-marker in order to either maximize the efficacy of the drug they're using or to minimize safety risks.
The very fact that you are recruited for such a clinical study may well create feelings of stigma, perhaps lead to discrimination in some fashion, as we've already faced in terms of the current way of analyzing and having access to genetic data. It also may mean the under-representation of some population groups. We now have a policy, as I'm sure you know, that many of our clinical trials have to have some diversity across the board. That may not be the case in personalized medicine clinical trials. We may well want to simply focus on that population where we think that drug is, one, going to be safe, and, two, is going to be most effective.
Moreover being — there are likely to be people in the larger population who while not in the subject cohort that you choose, may still be able to benefit from that drug. It's not clear how we will know that in terms of the initial trial and the results that are produced and translating that into health care. So that is another problem associated with personalized medicine that we'll need to think about as we move forward.
The second issue that I want to talk with you about is synthetic biology. What is synthetic biology? Well, it refers to the design and fabrication of biological components and systems that do not already exist in the natural world or to redesigning and fabricating existing biological systems. The goal is to try to build, if you will, new biological systems that are able to process information, manipulate chemicals, produce energy, provide food, and maintain and enhance human health and the environment.
In the traditional recombinant DNA with which we're all familiar there is an organism that you start with, and scientists are interested, if you will, in modifying that organism. In this case scientists and engineers are interested in starting from scratch and producing something very new, presumably with the kind of outcomes and benefits that I mentioned a moment ago.
Now, there does remain a critical gap between what we know and what we think we can do. We certainly have a long way to go, but clearly the opportunities are there really to create something new and also to create a different kind of life form than we've ever experienced before — that is, we are creating that kind of life form.
We had an indication of where we might be going in 2002 when scientists announced that they basically built from scratch the polio virus. They basically bought various strands of DNA and other chemicals from suppliers here and there, they put it altogether, and they were able to create the polio virus in a synthetic fashion. For science that was a rather important proof of principle, if you will, but for the public there was a great deal of uneasiness about where we were going and where we are going with this science.
The familiar ethical issues, which others are dealing with, have to do with the safety of these kinds of — these synthetic entities that are created. There is a lot of concern about whether or not they will produce hazards for those working with them or perhaps be used by others for reasons that will not bode well for us, such as terrorist activity. Apparently it — while, again, we're far from doing it, the feeling is that ultimately if people know what to do, it won't be difficult to get these kinds of materials and put them altogether.
There are a number of credible groups in and outside government that I think are examining the issues with regard to security and safety, but I think there are other issues that need to be examined, and for the most part, there's nobody focusing on those, and it may well be that a commission, a successor commission to your body, would be just the right entity to do that.
So let me raise a couple of those issues. We are going to be, in a sense, creating new life forms. That is, they will be able to replicate themselves. And, in fact, that's what we want them to do in some cases. And this does — it seems to me, raises some very interesting questions, including what will we view as our relationship, if you will, with nature if we are able, as humans, to create new life forms; to what extent any of those life forms require or demand respect; to what extent in terms of religious views will we be in some fashion intruding on what might be perceived as the role of The Creator.
It's going to limit us — I think it's going to force us to think a little bit about our responsibilities and the limits of our abilities, as well as the limits of our intentions and what our expectations might be. I think when the public really figures out what the potential might be with synthetic biology that there's going to be a lot of debate about the ethics of moving forward in this direction, and I think the scientific community needs to be prepared. And, again, a bioethics commission, such as this council, could play an important role, if you will, in sort of organizing those kinds of debates.
A second possibility is blurring the boundary between living organisms and machines. These organisms are really seen as engineered machines that can do something, whatever that might be — take care of the oil spill, for example, in the oceans. And so since a lot of ways that we think ethically is we make distinctions between living things and things that are not living. What is this that we're creating in the sense that we are combining, if you will, the essence of life in terms of genetics with some sort of engineering that enables it to do whatever it is to do. It may well be that we'll have to think a little bit differently about these kinds of entities when we we're able to create them.
And then there's the possibility of using synthetic biology in human beings — that is, if you will, to insert these new machines into humans in order to create some sort of change. That change may be for health reasons, but that change may also be for reasons concerning, let's say, human enhancement, a topic that I know that this council is already familiar with.
It also raises, of course, issues regarding human subjects research that we have to think through as to whether or not there are any real differences between working with this kind of synthetic material that we have created as opposed to the way we do things now, which will probably look very cumbersome in the years ahead.
In 2006 38 various organizations throughout the world issued an open letter calling for international discussion and review of the social, ethical, and economic implications of synthetic biology. It seems to me that a successor body to this council would be an appropriate public forum in which to have that larger global discussion, which I think is missing now.
The next topic that I want to talk with you about is something called virtual communities. Virtual communities are sort of computer-based simulated environments. They're basically physical environments. They have multiple users for the most part — at least, those are the ones that we are concerned with — and people actually interact in those communities with avatars — that is, they are computer representations of themselves tailored to reflect their desires, whatever they might be. And at the same time you can do all of this and remain — presumably remain anonymous, if you wish.
People enter these worlds, of course, with the same baggage they have in the real world, at least in terms of their values, in terms of their beliefs, in terms of their ethics, but they don't necessarily enter those worlds with the same kind of illness or disability. There are numbers of people with disabilities who are using these kind of virtual communities to sort of escape the real world that they live in, in which is so difficult for them to maneuver in order to have a different kind of life, if you will, in these virtual worlds.
During the past few years, the number of virtual worlds and the number of people participating in them has increased. One of the more well-known of these virtual worlds is Second Life, which has twelve million subscribers whose average age is 25. So our future physicians, our future health care providers, and our future patients are flocking, if you will, to these kinds of virtual communities. And if you don't have your own avatar yet, there you go. There's some examples. I leave you to decide which one is the real person and which one is the avatar.
So what does all this have to do bioethics, you ask. Well, it seems that these virtual communities and their residents have become the target of increased research, as well as the delivery of health care. For many scientist these kinds of communities have opened new areas of research, which have been funded by credible organizations, like the NIH, and published in peer-reviewed literature.
Just a few days ago perhaps many in this room realize that NIH announced its challenge grant applications for 2009. They were alerting the community what their priorities would be if they chose to take advantage of this extra money through the president's stimulus package.
Let me read to you what one of the priority targets is. "Improving compliance with diabetic regimen: Despite often intensive educational efforts, patients with diabetes commonly mismanage or under-manage their illness, despite the known ability of optimal management to reduce complications and morbidity. Interactions between avatars" — when was the last time you saw that word in a NIH announcement — "Interactions between avatars in virtual reality environments, such as Second Life, are known to influence behavior. Studies" — now speaking to the community — "Studies should explore the effectiveness of periodic physician/nurse interaction with diabetic patients via virtual reality environments in improving diabetic control as compared to standard practices."
Given the source, NIH, it seems to me that virtual worlds and research in health care delivery have — if you will, are the real thing. Now, some of the ongoing research is being used by researchers in various creative ways. This is a virtual community where we're having a virtual therapy session.
And this was published in a rather distinguished journal, Science, in December of 2007. In writing about, if you will, group therapy, the author stated that, and I quote, "Online virtual worlds provide the remote user or patient with a feeling of embodiment that has the potential to facilitate the clinical communication process. In the virtual world setting of the therapy session presented by this graphic, the therapist can remotely monitor the patient's psychological, physiological, and emotional responses with the use of biomonitoring systems and can modify the intervention, if needed."
So we're far along, if you will, in attempting to manipulate these virtual communities for purposes of research and delivery of health care.
And as you can see on this next slide from 2008, both of them, virtual reality therapy is being used to try to help PTSD patients, as well as autistic kids. In the first item dealing with PTSD, the director of the study covered by the article is quoted as saying, "I'm very optimistic. We think that aided by medications, virtual reality is going to be useful in ways to help people haunted by an experience confront their fears in a more complete and therapeutic way."
And with regard to the second report on autistic children, the researcher states that "a particularly convincing virtual reality system can help an autistic child transfer new skills back to a real situation. New technology can provide an in-between setting, particularly in a virtual world, that's not moving as quickly and doesn't have as many cues that might distract you."
There are lots of other studies in the literature that have demonstrated success in treating people with phobias that have left them psychologically and physically debilitated, but which have greatly improved after virtual therapy. And for patients who are living in remote areas, access to a virtual world may well substitute for a real world therapist who is simply not available. Even the CDC has a place in Second Life.
So as with any emerging technology, as you might imagine, we still have much to learn, but I think it's instructive the following quote from an NSF scientist and administrator just in 2007. He said, "We're at a major technical and social transition with this technology. It has very recently started to become a very big deal, and we haven't by any means digested what the implications are."
So that suggests to me a couple of things. One, it's becoming quite
important, but the other thing is, what is the extent of our empirical
data to show whether any of this is working beyond these kinds of
anecdotal studies. And the evidence so far really is based on a
lot of small N's, if you will, and anecdotal studies, but nevertheless
it does seem to bring results.
The fact is we don't really know what feature of the virtual world environment actually has a positive effect on therapy or health care, more generally, or what features might be detrimental or have no effect at all. We need to learn that.
We don't know how much of what is happening related to health interventions is being done within the confines of a closely monitored and well-designed experiment. The question of what are the ethical standards that should govern the exposure of patients and/or research subjects to virtual worlds is not, as far as I can tell, on anyone's radar screen, which leads me to mention informed consent.
Studies that have been done on virtual communities and behavior generally have found rather consistently that users treat these interpersonal encounters as having the same depth as face-to-face relationships. Well, does this mean that the ethical imperative to respect others will obligate researchers to obtain consent from the avatar?
Now, before you think this is a trivial matter, remember, in many cases these therapists or researchers do not know who is behind the avatar. They do not have the identity of that person if he or she wishes, if you will, to remain anonymous. So this raises the question, of course, of what do I need to get informed consent in a virtual community setting. And I have here a note to myself, "I wonder how the IRB would handle that one."
Now, there are also issues related to anonymity, security, confidentiality, and authenticity. Remember that virtual worlds work under the assumption that people behind the avatars are anonymous. And this has benefits because it may well lead some people who are uncomfortable in having their identity known participate in research or clinical care, all else being equal.
But it also has a downside because of identity deception, which is widely practiced on the internet and just as widely practiced in the virtual communities. So is the research subject today the same one as it was last week? Are two brothers operating the same avatar? And unless precautions are taken, people who roam virtual communities can roam free. They're free to roam anywhere they want to roam and there's nothing to stop anybody from dropping in on one of these therapy sessions and having a seat.
Needless to say that wouldn't happen in the real world. It's the kind of disruption that might well have adverse affects on the kind of therapeutic intervention, as well as the research that you might be doing.
And, of course, there's the issue of surveillance. Surveillance is probably much more likely, more easily achieved, and much harder to spot in this kind of environment than in the real world, and when you're dealing with health care issues, that's clearly something that you have to pay attention to.
And one other point I'll mention very briefly is that these virtual worlds pop up and down — that is, they may exist for years or they may exist for a few weeks or months. It doesn't take much for somebody who basically has set up the infrastructure to simply turn off the switch and the virtual community is no more. If you started a research project on that community, you realize some problems right away.
And then there's the final issue that I wanted to bring to your attention, and that's neuroscience. Now, I realize that the council has had neuroscience on its agenda in the past, although I couldn't find anything since 2004, and the science has moved on since then, as well as the way in which the science is presented to the public. Moreover there's a vacuum in the public discussion of ethical issues associated with neuroscience that's not true with its close cousins genetics and nano.
So let me say a few words about why I think neuroscience should rise up on the agenda again with regard to any new commission. There are areas of neuroscience that have made considerable strides since 2004. One of the exciting areas, if you will, is known as sort of brain/computer interface. Here you have a couple of reports. I'm sure many of you have seen the videos of people who simply by thinking are able to move a limb that they were unable to move even hours or days before. Again, it's sort of one subject at a time. It's not a revolution, but it's happening. We also find that people with Parkinson's disease, if they receive deep brain stimulation, results are produced which have had very positive effects on their ability to cope with the disease.
What happens in these cases is a computer chip is implanted in the brain or back here, if you will, and it monitors brain activity, it sends signals, and when the patient sends the signal that it intends to do something, the computer helps make it happen.
In fact, researchers in Japan have even tested a brain computer system that lets the user walk an avatar through the streets of Second Life while relying solely on the power of thought. Perhaps that's transferable to humans, as well. I suspect it probably will be at some point in time.
Now, while it's very satisfying to see some real change with people who suffer from these kinds of disabilities, the brain/computer interface also raises some interesting questions about where the boundaries are between the machine and the human brain. For example, if electrical stimulations in the brain can trigger conscious movement, as we're seen in the past with these different subjects, might it also be able to cause changes to one's behavior, memory, or judgment?
Families of some Parkinson's disease patients treated with deep brain stimulation have reported that the patient experienced significant personality changes, yet remained unaware of them despite the fact that they were highly disruptive to family functioning. How should we view informed consent in such cases?
There have also been some new findings in neuroscience about how people make moral judgments. The studies, granted, involving very few people suggest that there are specific regions of the brain that when damaged change the way people make moral judgments. So does that mean, if you will, that neurons affect how we form our beliefs and our values? Clearly these kinds of findings at least raise the intriguing question of the relative influences of brain circuitry, culture, and the environment on ethical decision-making.
One of the interesting ways that neuroscience has also changed is the way it interfaces with the public. The world-wide web makes it quite easy to directly reach the public whether to recruit research subjects or to promote products for the mind. Here's a company called Northstar, and it claims that it is a medical device company focused on developing and commercializing innovative neuro-modulation therapies to restore function and quality of life for people suffering from neurological diseases and disorders.
Well, that's all well and good except for the following. This news article reports on the demise of that company. It starts off with ominous words, "Northstar Neuroscience is Toast." Basically the headline conveys the issue. Northstar Neuroscience shuts down ending experimental depression trial. If you read a little bit further in the article it says that the company has a plan, which will involve paying off remaining liabilities, like its lease and its clinical trial obligations.
Now, I have no interest in thinking about the moral implications of paying off its lease, but it does seem fair to ask what those clinical trial obligations are and how the plan deals with them. What's happening to all of those patients? How does the company define its obligations to them? And were the patients initially informed that completion of the trial depended, in part, on the success of a company to attract adequate venture capital.
Clearly the increasing connection between research and commercial issues are raising questions about the integrity of science, the treatment of human subjects, and how the public perceives neuroscience. And all of this is happening when the public is exposed to headlines such as these, yet there's no coordinated national effort to explore these issues.
Nano has its ELSI program, genetics has its ELSI program. What
about neuroscience? I think that while these issues are not unique
to neuroscience, they're worth exploring in a more public way and
suggest that a future council would want to take them on.
So, finally, let me conclude with one last statement, and that is the world is increasingly becoming global. Certainly that's true of science and engineering, and I would like to see any future body such as this spend some time to take a look at some of the international implications of the kinds of things that they are focusing on.
It probably will do us all better if both we learn from others, as well as we contribute to the thinking and work of others in these areas. Ethics is not the domain of the U.S., and more and more research being done internationally suggests that we have to have a better understanding of how different ethical perspectives might affect the advancement of science and technology and its uses, as well. And that seems to me to be something that any future council ought to have as a regular part of its assessment and analysis, whatever the issues might be.
Thanks very much.
CHAIRMAN PELLEGRINO: Thank you
very much, Dr. Frankel. Our next speaker is Dr. Nancy Kass, who
is the Phoebe Berman Professor of Bioethics and Public Health at
the Berman Institute of the Johns Hopkins University. Dr. Kass.
PROF. KASS: Thank you. I'm very pleased to be invited here and to have a few minutes, and I look forward to the part of — the part of the meeting where we can get feedback and discussion going. Let me give you two disclaimers before I really get going on the slides. The first is a logistical one. I've tinkered a little bit with the slides since they were handed to the staff here and distributed, so you'll notice a few changes. The substance is really the same, but it really is tinkering.
The second, I feel a responsibility to say to this group that I'm no relation to Leon Kass, even though I'm asked that all the time. And as a matter of fact only a month ago I was at an event in my neighborhood and there was a man there who had traveled there for some coincidental reason and he spent about five minutes telling me all the ways he'd known my father over the years, only at the end for us to discover that it was not my father at all; it was Leon Kass. So with that, let me move forward.
So I'm not only always personally grateful when I'm invited to speak before any group like this, but I guess I also feel like I want to thank you for including public health on the agenda. I have a tremendous bias here and that maybe is evident from my background. I did my doctoral training in a school of public health, and when I arrived at that school of public health — and this may be true for all professional schools; it's just the only one I've ever been through — I was struck by how many people there were there who were just tremendously idealistic.
Public health schools are full of people who want to save the world, and they want to save the world in part because of their commitments to the under-served. And when I started to learn about bioethics — in great part from Ruth Faden, who's in the audience — it became clear that bioethics is significantly interested in the well-being of the under-served. And obviously my own path gravitated much more toward bioethics, but I think that the conceptual clarity and agility that people in bioethics have could be a tremendous contribution to the fundamental goals of public health.
So I'm going to — I was challenged to think through, really to limit myself, to a number of issues that could be discussed in half an hour. Here's the laundry list of things I'm going to talk about. In my mind I actually can draw some connections of one to the other, but that's not really my goal. My goal is to just throw out a bunch of issues, and I think these are issues that could all stand to have more both conceptual clarity through a bioethics lens and ideally some public policy guidance that would be particularly relevant to this context of public bioethics.
So the first is public health research. And obviously presidential, national, public commissions in this country have devoted probably more attention to the area of research ethics than any other topic. Some extraordinary work that has led to regulations, to foundational thinking about how we should approach human subjects research has come thanks to the work of national commissions.
What perhaps deserves additional attention building on this work are some of the questions raised through what I'm going to call public health research. So let me tell you a few of the issues that I think are at stake and then I'm just going to walk us through one example as an example of the kind of research that goes on in public health where I think there are some questions that deserve more attention.
So in general in public health research, first of all, we have this complication that researchers sometimes think of the subject of their research as a population, rather than an individual, and yet our guidance assumes that we have an individual in front of us when we're thinking about consent and autonomy and benefits and all of that kind of thing.
As an example, there is a method in public health research called cluster randomization. We're probably all familiar with randomized controlled trials in what I'll call the traditional sense where patient A may be randomized to one drug and patient B might be randomized to another. Cluster randomization means that an entire group is randomized to one intervention and an entire other group — it could be one managed care organization and another managed care organization — the other group receives something different or receives no intervention.
A couple of examples that I put on the slide — I've worked a little bit with a tuberculosis prevention trial in South Africa that involves hundreds of thousands of gold miners. But the way that they allocate this TB preventive intervention that they are testing the efficacy of is an entire shaft of ten thousand gold miners either gets this preventative intervention or an entire shaft doesn't.
Another kind of example, there could mass media campaigns where one city would get a mass media campaign related to something in health education or something that people think will promote the public's health; another city wouldn't. There's evaluations later across the entire population in aggregate of what the health benefits are or aren't.
So, of course, this raises really interesting questions with regard to consent, which, again, is this foundational assumption we've bring in to public health, to human subjects' protection policy. So what kinds of permissions are needed for either of those kinds of studies. Who has authority? Right? One city is going to get all these billboards and radio announcements and one city is not. Does that mean that people in the city where they are not getting the intervention need to know that another city is getting them and they're not? Is individual awareness of that needed? That's the informed part. Who, if anyone, needs to provide permission for this kind of thing happening, the consent part, and is the answer to any of these questions relevant to the level of individual — now, getting back to the individual — risk or identifiability at stake in any of these designs?
There's a lot of work in public health research, which is probably also to some degree true in clinical research, where there's an intertwining of practice and research — lots of possible examples here. There's been a lot of attention recently to quality improvement. Again, some examples I'm familiar with close to my home is, for example, the city health department might decide to do a new innovative program. It could be an outreach program to try to reach hard-to-reach populations who have some particular public health need, but as a component of their outreach program they want to evaluate it, they want to publish it, they want to treat it both as a practice intervention, a program that comes out of public health funds, and they want to evaluate it so that other cities can learn from it.
Well, again, there's all these questions of is it research, what are the oversight requirements, are there any consent requirements? Just some interesting questions that I think deserve more attention.
So I want to talk about another flavor, another category of public health research that has caused a lot of angst in the bioethics world and where I think more guidance remains needed. So I'm going to call this type of approach community-based prevention trials, although you'll see as I walk us through it that there's a particular context in which these community-based prevention trials exist where I think some of the particular ethics challenge emerge.
So here are some of the assumptions. Public health, generally, not yet in the research world, has a mandate, a legal mandate to intervene where major public health problems exist. And, of course, we learn through research and through data that have been collected for more than 100 years that major public health problems often exist where there are bad social conditions and generally where there is evidence of societal inequity.
So here's another piece of the context to bring into thinking through proposing a research trial. There are a lot of contexts where there's bad public health outcomes and there are interventions that we already know would make a difference for improving the health of those people. It's not that we need more science there. It's that for some reason the people in Africa don't have clean water yet. It's not that we're not sure if clean water would make a difference for them, but they don't have the clean water.
And so interventions that are effective are not being implemented due to costs, due to feasibility, due to different priorities, whatever. So ethically there's this question, can researchers go in and test the effectiveness of an intervention that they think will be what I will call a harm-reduction intervention, will, for example, ameliorate what happens when those kids in a poor country get diarrhea, tests of very feasible, you-don't-need-much-training, education, or-refrigeration-way to do oral rehydration.
Can you test interventions that ameliorate the public health problem, but that aren't addressing the fundamental problem? And, again, there are many kinds of examples of this: bed nets, oral rehydration. Many of you will be familiar with the perinatal AZT trial controversy of about ten years ago. And I'm going to walk us through one that, again, happened in my home city of Baltimore.
So I'm going to talk about the Baltimore lead study, not because I want us to get into a distraction about what happened there, but as an example of something that where this kind of question of trying to propose — of proposing a study that looked at the effectiveness of an intervention that might reduce the public health harm when other strategies already existed but were not being implemented when this kind of study was proposed. And not in a very poor country; it happened in Baltimore City.
So here's the background for this particular study — again, just to be an example. It's been known for close to 100 years now that lead is dangerous for children. In 1931 the use of new lead paint was banned in Europe. It actually didn't happen until the 1970's in the United States clearly due to policy decisions that were different, not because the data weren't available.
Okay, so it's been outlawed in Europe since 1931. Fast forward to the 1990's in Baltimore. This is 15 years ago. And unfortunately in the City of Baltimore here in the United States of America, 90 percent of the houses were old and therefore had lead paint in them somewhere. My house that I live in has lead paint. It just happens to be covered up by many, many, many other layers of non-lead paint.
There were, however, in some sections of the city that were not
at all affluent many homes with peeling paint and a lot of lead
dust that was routinely around for a variety of reasons, including
old windows that every time they were opened and closed scraped
and generated dust. And 60 percent of the children in certain neighborhoods
in Baltimore 15 years ago had highly elevated lead levels.
So the logical conclusion, because we know lead is bad, is that we need to change public health policy. This is not a situation that automatically screams for research. In my mind this is a situation that screams for policy change. Well, there's a little research that happens as part of this story.
There's research that looks at how abatement methods were done in the seventies and eighties and, lo and behold, demonstrates that the way they used to be done of scraping off all the paint and scraping off the windows turns out to generate a lot of risk through the generation of dust. Okay.
So they do another set of studies and demonstrate a very different way to do abatement with both approved personnel and covering up the lead, rather than scraping off the lead. Highly effective studies shows that makes a big difference. Again, this should lead to the logical conclusion — a lot of kids are getting sick and having brain damage — bad thing. We now know how to intervene. Okay. Logical conclusion, we've got the science. We should intervene.
Well, it doesn't happen. There's no policy action in the same way that the use of new paint wasn't banned in this country from the thirties to the seventies — it took forty years — there's still a lot of policy action that should have happened that hasn't happened.
So that led a group of public health researchers to say, "Maybe what we should do out of this duty to improve the health of these kids is try to find some other strategies that could make a difference, where maybe the policy world would accept a requirement that landlords have to intervene if it's only going to cost them $1,000 rather than $12,000, which is what abatement would otherwise have cost them.
So there was a research study proposed that was a randomized trial where different houses in these neighborhoods in Baltimore where the housing stock was of pretty poor quality and there was a lot of lead risk, were randomized to three different kinds of interventions of different amounts of money doing part of these kinds of effective things, like replacing the windows or putting mats down on the floor, and there were two control arms.
And the control arms were not houses that got no abatement, but they were new houses or houses that had been completely abated for other purposes. And the kids were monitored regularly. And lo and behold all three of the interventions of doing just part of the total abatement reduced the lead levels in the house by more than 90 percent. They were shown to be — in the context of research, thinking as a scientist, highly effective interventions.
Lawsuits were brought against the investigators because they didn't do all that they could have, because they took what I'll call this public health approach of harm reduction rather than doing everything possible. And specifically not only were they told they should have done full abatement, the alternative is they should have moved the families outside of Baltimore.
So it leads to some perennial questions for people who do this kind of research. There's often unjust background conditions that prompt public health people to seek interventions, but there's this conceptual tension. Does testing interventions in these settings promote justice by identifying strategies that will improve these kids' health or improve the public's health, more generically, or does testing in this kind of way, does designing a study in this way, exploit the poor or condone the injustices there or suggest that public health will accept substandard approaches for people who are disadvantaged.
Important conceptual work needs to be done there, and, obviously, practical guidance for, for example, all my colleagues at the school of public health, who I really believe want to do right thing and come to us and say, "So what are we supposed to do now."
So I'm going to move on to another area that I'd love to see a future council or commission provide some guidance. And, again, in my mind there is possibly some link to the last set of examples. So one solution that actually was proposed as at least being relevant and maybe having a voice for the kind of study like the Baltimore study was getting community input. How does the community view this and do they want that kind of study done at least in the interim until there is more policy action?
And as it turns out this idea of having community engagement as at least a strategy in responding to a bunch of tough issues seems to be popping up everywhere I go in bioethics circles. So those of you familiar with the regulatory guidance about emergency research know that it's a requirement now that there's some kind of community consultation.
In international research, like that gold mine trial and a bunch of other public health trials, there's now sort of a — not a ethical mandate, but it's becoming more normative for there to be some kind of community engagement, community input in planning or at least executing a trial.
Obviously this urban research, like the Baltimore example — there's this notion of public engagement which is becoming more popular in health care decisions and in bioethics-relevant decisions. Health policy decisions — now there's probably a lot more attention to health reform. The Oregon Medicaid decision strategy was an example of public engagement. Preparedness allocation has taken on this idea of community engagement, public engagement, getting members of the public together and saying if there's scarce vaccines, who should get them, what do you think.
So this leads to a whole bunch of really interesting questions. First of all, what is community engagement? Again, all these circles seem to say, "Ah, ha, part of the solution is community engagement." Well, are they all talking about the same thing? And why is it relevant to bioethics? Are people saying it's helpful because it's an input, it's another source of information, or are people saying that it's actually determinative, that if we hear from the public that they think these people should get vaccines and these people shouldn't that we somehow have a responsibility to follow it.
Now, what's the authority of communities or the public in determining what is right. And if they think it's right for them, can we override their preferences out of paternalism? I mean, I remember doing a study years ago, a very different context, where a bunch of drug users and HIV infected women had very different views about what should happen with regard to drug use and pregnancy and reproduction, but there were some members who said basically, "Lock people up, sterilize them. Don't let them do this stuff." And these are women talking about themselves. And so does that mean that the right answer is to do that? Is that the only input that's relevant, or are there other ways we can think about what's right, separate from what people themselves say is right for their own community.
So that just leads me to another specific example where this idea of community engagement has emerged as a strategy, which is preparedness. And a lot of the work that's been going on in preparedness by health departments in every state and certainly federally has been related to pandemic influenza, but there's also been a lot of work related to disaster preparedness or bioterrorism, more broadly.
So there are already groups that have taken on this question of preparedness and allocation and justice. The Institute of Medicine has looked at it. The CDC has looked at it. Every state is required to have a plan. The plans are remarkably different, and there remain some foundational questions for bioethics here that in certain ways are reminiscent of the early questions that animated bioethics sort of when it got its start in the seventies in terms of allocation of scarce resources, in terms of who should be saved, who was important, is age relevant?
And while we have dealt with this issue of allocation of scarce resources before, the context is a little bit different. We're not simply saying whose lives do we want to save, but we may be saying that the emergency nature here is a little bit relevant or potentially could be relevant to who should be saved.
So is one's role in society relevant? Ought we to give special priority for people who I'm calling are instrumental to the well-being of others? If giving a vaccine to me would mean that I could go out and help 100 other people, ought that give me higher priority than just randomly distributing it with no attention to that kind of thing? And if we do give special priority in any way that's not random, ought we then also to have special safeguards for those who most vulnerable, who in no way are in a position either to help themselves or certainly to help others.
Okay. So I'm going to now raise a very different kind of issue that leads into all three — that for me is related in certain ways, again, by this chain of events to the last three issues I want to talk about.
Environmental ethics is at least in my opinion an area where we in the bioethics community have been relatively silent. I don't mean to suggest that there is no work in this area by any means, but I think compared to a lot of other issues that we've taken on with great gusto and with a huge depth of literature, there is relatively little in the area of environmental ethics.
Part of it perhaps is in all of us not being clear on what the boundaries of bioethics are. And I don't mean to suggest necessarily that there's a clear answer, but if we think of bioethics as in some way being related to science or health, how is it that environmental concerns are related to this.
I have a colleague who often says, "Part of the problem is that when we say work in environmental issues, people think of the salmon floating upstream and they don't think of it as the environment in which people live, the context in which we are surrounded," which is obviously a very different picture of environment.
So if we think of the health effects of war or the health effects of radiation exposure or the health effects of pesticides in food or climate change and its domino effects or deforestation, which people do sometimes as a response to poverty, as a response to the tragic circumstances in which they find themselves. But those behaviors in turn lead to effects on the environment and on animal health and on human health. Arguably these start to crossover into areas that probably most people would agree are related to the kinds of topics people in bioethics think about.
So within environmental ethics there's a particular set of questions that people say are related to something called — that they label environmental justice. And this is, again, this perennial theme in bioethics of justice, social justice. Environmental justice, I think, means we get concerned when there are inequities in the distribution of environmental hazards. And since we know environmental hazards — by definition, that word — can lead to bad health consequences, it means we are then witness to inequities in the distribution of the health consequences of these different environmental hazards.
And then there's sort of salt in the wound, if you will, further injustice if that chain of events happens and then the people who are exposed disproportionately to these negative health consequences from this unequal distribution of hazards are the kinds of people who happen to have less ability to navigate the health care system due to limited knowledge, disenfranchisement, under insurance, lack of insurance, et cetera. And these issues are relevant domestically; they're relevant globally.
And I just put up here I think there may be what I'm going to call some bioethics anxiety that is not a question of are these important issues, but are these our issues? Is this the kind of thing we're supposed to take on, or is somebody else supposed to take this on?
So this is, in part, going to be related to this broader issue, which is social determinants of health. It seems like, you know, what goes around, comes around. I'll have a slide in a few minutes that in certain ways public health got its start thinking about social determinants of health. I think in ways some of what the early commissions looked at, the president's commission, was, in part, related to social determinants of health.
There is a resurgence of interest in social determinants of health, is all that I can say, and there are plenty of issues that remain unaddressed. So it's currently a new huge initiative at the CDC. Some of you are familiar with a report that was just released by the World Health Organization — I'll have a slide on that in a minute.
Mark McClellan, former FDA commissioner, former head of CMS, co-chairs the Robert Johnson commission to build a healthier America. He said in one of their reports on children's health that was released a few months ago, "Most of our efforts to improve health have focused on improving quality, access to, and affordability of care. While these are important, support for better health that is associated with resources and community matters as well."
So here's a few quotes from this WHO commission, which, again, also just came out. This WHO commission — and I will just put in an editorial comment, I think from my reading this is just more a cultural norm of Europe than it is cultural norm of the United States. The language is stronger, and it says things like, "Inequities are killing people on a grand scale. The toxic combination of bad policies, economics, and politics is in large measure responsible for the fact that a majority of people in the world do not enjoy the good health that is biologically possible." Again, this idea we have the science; somehow there's not access.
And then finally they say, "Social justice is a matter of life and death. It affects the way people live, their consequent chance of illness, and their risk of premature death. We watched in wonder as life expectancy and good health continue to increase in parts of the world and in alarm as they fail to improve in others."
So why is this part of public health ethics? The Institute of Medicine defines public health as what we as a society do to collectively assure the conditions in which people can be healthy. And as I was saying earlier, if you go back to the roots of public health, a lot of it is about social determinants.
The school where I've spent most of my career, Johns Hopkins, recently changed its name to the Bloomberg School for obvious reasons related to philanthropy, but before that was called the Johns Hopkins School of Hygiene and Public Health. Right. There's real reason why when it started as the first school of public health in this country it was related to social conditions.
So in the 1800's Edward Chadwick in England showed this relationship between class and life expectancy. He demonstrated that there was more than a twofold difference in life expectancy between the upper and lower classes. Also in the 1800's there were maps created of housing conditions and of garbage heaps and those were linked to disease and health status which were directly correlated.
At the end of the 1800's in this country there were state and local boards that were created and they were required to enforce sanitary regulations and that was in the name of improving the health of the public. So that's the — environment, social conditions, and equity have all received the attention of what I'm calling the public health pioneers.
And, again, a lot of other evidence — I'll go through this really quickly because probably everybody here knows it, but there are a lot of important research studies that remind us that even among people who all have jobs and all have access to health insurance, inequities lead to differences in health. The way health studies, which is sort of the landmark studies in the United Kingdom, show that occupational status was directly linked to health outcome among people who all were employed and insured.
The MRFIT trials showed an inextricable link between income and death. And individual risk factors we learn — you know, when we say, "Well, there are a lot of health outcomes that are really sort of our own fault — smoking and obesity and lack of exercise" — it becomes more complex when we look at the data and realize that those are also deeply correlated. They cluster by social position.
So that becomes a little more complicated and at least deserves attention in a discussion of social determinants. Dan Beauchamp, one of the people I think of as, again, a pioneer in this area of justice and public health said that "If we continue to devote our attention to individual interests and individual behaviors, we will plague our attempts to protect the public's health. And the community is not simply insuring non-interference from others. It also means a shared interest in the developing conditions for health and safety." Again, an idea that the conditions of social determinants are going to be highly determinative for the welfare of our society with regard to health.
So how can bioethics contribute or how can public bioethics play a role? There is in bioethics deep expertise in the area of justice. There's deep expertise in different conceptions of justice, different theories of justice, and different duties of justice. And we can build on that important work that was done earlier.
Bioethics at its core wants to ensure arrangements that are both respectful and just. And the challenge is that sometimes, once we see all this data that says, "Social determinants make a difference, inequities make a difference," sometimes the way that we would best intervene are also in areas that I would say cross sectors that are not really related to what the health department does, but what other groups do.
So the person who was just named the interim head of the CDC said that one of the things they're going to try to do is work with other people in public infrastructure sectors to make sure that when there's roads built, they always build sidewalks. Okay, so that's not something we usually think of as part of a health department concern. Commerce, the availability of fresh foods, and a few people know that I'm starting to increasingly say whenever I think about this issue that I think if we could do one thing to improve the public's health, we should put more money in this country into public education.
And probably if we took half the budget of health and half the
budget devoted to new business or advertising and put it into public
education, we would probably have better health outcomes and certainly
more qualified people to populate our jobs and professions.
It is a public policy land mine, however, of considering the effects of different forms of governance and different economic strategies that may be at stake here, and I'm fully aware of that.
The last thing I'm going to talk about and then I will end is the idea of global justice. So I see that Dr. Frankel also ended with this plea for us to start thinking globally and not only domestically, and I feel that very deeply. Partly it is because it just gets harder and harder to think in a vacuum because the world doesn't work like that anymore. The links related to social determinants are, if anything, more profound when you look globally. And arguably U.S. bioethics thus far has devoted less attention to global concerns.
These are critically important questions, but they are also important symbolically. And, again, this just echoes completely what Dr. Frankel said. It is important for us to contribute and it's important for us to show the rest of the world that we care. There's a lot of really important work to be done out of bioethics in defining what are just arrangements and what are the justifications for the United States making this part of American policy.
There is different work that's being done in this arena. It's interesting
that I sort of only realized after I made the slide that even though
I think of these people now as Americans in terms of working here,
both of these people [slide mentions Peter Singer and Thomas Pogge]
have their roots — neither of them was born in the United
States, which, you know, who knows what that's about, but there
are different justifications that are emerging for why it's important
to work on global justice.
I'm not going to go through them here, but the point is there's a lot of room for a group of thoughtful people to take on these issues and think it through. Is there a duty? Are we simply being compassionate or is there a stronger duty than that? And what is the extent of some kind of duty?
So then my last slide is really how we translate scholarship and important conceptual contributions into action. There's a real difference between a public bioethics body and a group of bioethics scholars in terms of their mandate. And it's important to think through how justice scholarship, which is, I think, in its nuance and sophistication breathtaking — how that can translate within the confines and constraints of real-life public policy that, again, deals with multiple sectors and multiple interests and multiple agendas that aren't always rational.
So how do we work with public policy for public bioethics to identify strategies that are realistic and we think based on data could lead to public health improvement. We need work that is both conceptual and strategic, and when you bring together boards like this, you have the luxury of finding the best people and they can do both of those kinds of tasks.
How can we think about furthering justice in a world that right now when we look around it has human rights violations and injustices left and right? What can be learned from regions who actually have made headway with regard to reducing inequities. We have to have positive role models and maybe we can learn some things there.
The boundaries between local and global are disappearing and, you know, just this final slide, which, I think, is maybe part of what being part of a U.S. presidential or national bioethics commission is all about. As is true probably for most of us in the room, we are the privileged, the responsibilities of the privileged to take on these issues in order to serve those who can't have a voice themselves is enormous. Thank you.
CHAIRMAN PELLEGRINO: Thank you very much, Dr. Kass, for opening up a whole new area, issues, and problems, and certainly, I think, appealing to our sense of community responsibility and what bioethics might do for it.
Rebecca Dresser has agreed to open the discussion on the part of the council.
DR. DRESSER: Well, thank you two for a rich review of interesting topics. I would like to ask a meta question. We can think about national bodies like this as having to allocate resources — limited time, limited energy and ability to look at different topics. So when a group does not have a specific policy directive, how do you think the group should decide what to address?
Our executive order actually has a number of criteria, which I haven't memorized, but I think were pretty good. They said things like look at whether other groups are adequately addressing the topic. I can't remember what they were, but I guess I'm interested in your view.
Obviously there are issues about when something is right to consider, when it's premature, when it might be at the point where something — a report might gain some traction, because a lot of times these documents come out and they go into a black hole and no one ever sees them or reads them. You know, when should you revisit an old topic, when should you highlight a topic that you think is under-addressed, should the process of decision-making be somewhat systematic, so should you survey people, experts, ordinary people about what they think the important issues are, should it be more flexible.
I know often for us we've talked about different possibilities and it's been more of a deliberative decision about what we should go forward with. So if you have any thoughts on that, I'd be interested. Thank you.
PROF. KASS: Rebecca, you give us too much credit in thinking we might have the answers to that. I mean, obviously I have a few thoughts on it, but I don't want to suggest that my thoughts are any wiser than anybody else's around the table.
Some of the things that occur to me are a lot of what you touched on. It seems like picking issues that both involve some paradigmatic cases that maybe have prompted some public interest in the last couple of years, but that also are tied into much larger issues that could have relevance beyond those cases that sparked a lot of attention is one type of criterion that could be helpful, that there's sort of — there's interest, everybody is excited, we can get — we can get our hands around why it's important, but when this particular question dies down, the conceptual thinking behind it will have relevance to a lot of other topics.
Where a commission or council is at that moment in time and what's going on outside of it, of course, is relevant. What's going on with the politics here, what's going on with the politics globally is going to be really relevant to whether this is the right time to take on environmental ethics or global justice or anything else. So that seems to be relevant.
I think the question of how much other bodies are taking on a similar issue is an interesting one. Certainly if it seems sort of what I'll call directly duplicative of what another body in U.S. government is doing, that seems like a waste of resources. But if, for example, a group in Europe has decided to take this on, it could be that it's very complementary for us to take on the issue. So I think having an awareness of the external landscape ends up being helpful aside from the importance of the issue.
DR. FRANKEL: Rebecca, you had a very good list, and Nancy has added to that. I would only add that councils, public bodies like this, should be sure to have mechanisms built into them whereby they can — and I use the words in quotes — "survey" the public. Now, that doesn't necessarily mean a social science survey. It may well be. It may well be that, but have a variety of different strategies and mechanisms for listening and you'll get a lot of information.
A great deal of it, of course, will be in conflict, but it might be useful for the next commission, depending upon the breadth of its charter, if you will, to sit down very early in the game and deal with that issue before you get too further along. It seems to me it's a really important one.
CHAIRMAN PELLEGRINO: Thank you. I'll call Schneider and Bill.
PROF. SCHNEIDER: You have confirmed — this is really directed to Dr. Kass. You have confirmed my already deep belief that there is a lot of really, really important work to do in public health. What mystifies me is why you think that anything good is going to happen by creating another commission or asking the commission to look at these things.
I think the reverse is as surely likely to be the truth in at least one of the areas that you talked about — that's the Kennedy, Krieger, Grimes lead paint study. There are actually already — as you, I'm sure, know, has been a very, very, very elite commission which looked at it. It was, I think, an NRC/IOM commission that looked at it. And it issued one of these reports and it said you may not do this kind of research. It is wicked and criminal and cruel to do this kind of research unless you have all kinds of things, particularly including the consent of the community.
I've read the literature written by the people who actually tried to get consent of the community for informed waiver cases, and it's a joke. It's a joke because the community is an entirely artificial construct. There is no such thing as "the community." The community gets defined as everything between a neighborhood and the State of Mississippi.
When you try to get hold of the community to get them interested,
nobody shows up. You have more people from the IRB and from the
research groups than you do from the actual community. And why not?
Who wants to spend his time sitting and listening to somebody talk
about these sorts of things? One reason you have elected officials
is so that they can make these kinds of decisions if the community
really needs to be consulted. That's what democracy is supposed
to be about.
If I were giving advice to one of my students who was a joint degree candidate in public health and law, I would say the last thing that you should do if you want to help the world is get into an area where you're going to be stopped from doing good research like the research that was done in the Kennedy Krieger case by another commission that wants to find more ways of stopping research.
PROF. KASS: So thank you. It's an important question. So clearly there's an assumption there that we already know what the commission would say.
PROF. SCHNEIDER: Well, we've seen the commission's statement.
PROF. KASS: Well, so one — so we can quibble over exactly what the conclusions of that IOM committee were, but the fact that one group with one kind of charge makes one conclusion and a public commission that might weigh in with certain kinds of concepts or certain kinds of general goals to be preserved that might not look exactly consistent. So there's a consistency problem that always has to be dealt with when there's a bunch of federal groups.
But I don't think to me that's yet a convincing argument that we don't need to go there, but let me say something about the way in which I could imagine there being a role for a national council or commission. I actually don't in any way think that it's the right role of a national council or commission to weigh in on specific cases.
I think that doing — part of it you get into the "he said, she said," what were really the facts, what were people's intent, but partly I think it's a distraction and I think from doing a lot of research ethics in this case often the devil is in the details.
What I think is far more helpful is establishing certain kinds of conceptual goals — for example, when one does public health research — and examining this whole idea, this whole question of is it ever going to be ethically acceptable to test an intervention that provides some health — that ameliorates public health problems when we know that there's a whole variety of other public policy interventions that could make more of a difference. And again, the paradigmatic example is bad water and oral rehydration.
I think that providing general conceptual goals and general conceptual
recommendations is a very important role for a commission, whereas
weighing in on individual cases I think is not. And let me give
you an example of that. In another one of these public health research
quandaries, the perinatal AZT studies, which I'm sure you also quite
familiar with — it was very telling that both the people who
thought that those studies were completely unethical by virtue of
using a placebo and the people who thought that the studies were
justifiable in using a placebo invoked the same tenet from the Declaration
of Helsinki in justifying their views.
And for some people the conclusion was Helsinki needs to be revised, it's a terrible declaration, what help is it anyway. And I had completely the opposite view. And it may be that I'm misguided — and we're all entitled to our opinion — but for me Helsinki lays out general goals and concepts that are important for us to live by. And in certain ways they're general enough that most people can live by them.
And once we start to get too specific — which we have to do in individual determinations — then I think we get ourselves into difficulties. So I could imagine taking on this new piece of human research challenges and thinking through the ethical concerns and ethical goals related to that, but I would hate to see us start to weigh in on any specific examples because it's going to be different from the next example.
CHAIRMAN PELLEGRINO: Thank you. Dr. Hurlbut.
DR. HURLBUT: I just want to add a voice of appreciation for what you've said to us. I think it's a very compelling general domain and important, and we — several times in our work I thought we could have been extended some of what we said on other subjects to include some of what you've alluded to. And let me just give one example.
Specifically, when we did our report called "Beyond Therapy," we talked about not just the human questions and basic issues of what human goods are, but some of the dangers of the biotechnologies that people have exaggerated schemes in their minds for how they're going to transform their children or themselves to make superior human beings.
And I think there's a way to connect this in with what you were talking about because there's a very fragile balance operating between natural human biology and the natural environment of our evolution and adaption. We should take that deeply seriously, not just as a sort of public health issue, but as a personal issue and as a professional issue in medicine.
Anybody who is a doctor after awhile, if they don't start out this way, realizes that the best policy is to do as little as possible by way of interventions in human life. Even seemingly simple drugs like Tylenol have an amazing number of effects. Hundreds of genes can be up-regulated or down-regulated by simple drugs.
And this has all come home to me that at least one good thing that's coming out of the financial world's meltdown and that is if we can't even understand how credit default swaps work, then we should be a lot more humble about how biology works, genetics works, and so forth.
And one arena that — I want to just underscore this — one arena that we've really, really neglected and it's just staring us in the face is the damaging — potentially damaging effects of alterations in our — what you might call the biochemical milieu in which our new members of the species are gestating. I think we're going to find out with great regret that some among the 80 to 100,000 industrial chemicals in our modern world are affecting embryogenesis in subtle, and in some cases not so subtle ways.
There's a huge — I don't want to use too bad a word for it, but there's a huge rethinking of this due and it connects very well with what you said. And if a future bioethics group takes up issues in this way, at the very least it will the alert the general public to take this more seriously.
CHAIRMAN PELLEGRINO: Thank you, Bill. Dr. Frankel, did you want to get in on this aspect at all?
DR. FRANKEL: No.
CHAIRMAN PELLEGRINO: Thank you. I have to revise the schedule again. Let me tell you what it will be. I have the next speaker, Paul McHugh coming up, but we can carry this discussion to 3:45 and then we're going to have a break and reassemble at 4:00 o'clock. I'll try to handle this as gracefully as I can. Paul.
DR. McHUGH: I'll try to be brief then, Pellegrino, but I, too, want to thank you both for your wonderful presentations. And I want to concentrate on the issue of public health and global public health because I'm also a member of the faculty of the Johns Hopkins School of Public Health, and it's a wonderful place, just as Dr. Kass described, full of eager, positive-thinking, committed, willing-to-do-without people.
But as I teach over there and engage in these very happy conversations, I'm always having the same argument, and the argument is we want to do great things, but very often we are very naive about the issues that need to be dealt with and we're very naive also about our own biases.
And I wanted to just talk a little bit about that because I want to make a point different from you, Dr. Kass, that I believe, in fact, specific examples are exactly where we have to work in public health in order to improve on ourselves and particularly on our naivete. And I'll give you two examples where I think that the commitment to a particular point of view or a particular viewpoint overlooked the underpinnings that led to disaster.
The first one was described by Helen Epstein in her book, The
Invisible Cure, where she showed that the World Health Organization,
which is after all the major organization that deals with issues
of global health — because of their commitment to the idea
of harm avoidance and condom distribution led to a neglect of the
discovery amongst the women of Uganda that the issues in the transmission
of AIDS amongst the African people were related to aspects of behavior
and if they could encourage the reduction in partners, rather than
the distribution of condoms, they would promptly reduce, as they
did, the incidence and prevalence of HIV amongst the Ugandans, whereas
at the same time the World Health Organization, knowing of this
data, but burying it, continued a policy of condom distribution
in Botswana Land and all where the HIV conditions continued and
This was an issue related to the way we're thinking about how to manage human sexuality and the knowledge that fundamentally it's partner reduction that does most to protect from sexual transmitted disorders was neglected. This point — I make this point now because our school of public health in its recent alumni journal devoted to sexuality — and made a lot about it — had article after article saying how brave we were to fight the taboo against sex, but neglected to mention anything about this important public health disaster, really.
The other thing is specific examples are terribly important, and
we should be looking at particular places where public health goes
in relation exactly to what you're saying about impoverishment and
particularly the way government might play a role in making things
I think, for example, the suffering of Palestinian people in the West Bank, for example — if you visit there, it's quite clear that all the monies that the American people are giving to help the Palestinian people is going right into some Swiss bank account of the leaders of those countries, rather than to the health of those people, who continue to suffer from the poor water supply and the dusty conditions there.
And I wonder whether we in the schools of public health are telling people how much importance it's going to be to back the development of a more democratic, equitable society before real health will be given, and that is perhaps as important as the health supply themselves. So it's specific examples that I think are going to help generate — help direct this wonderful enthusiasm that you and I find and love in our school.
CHAIRMAN PELLEGRINO: Thank you, Paul.
PROF. KASS: Thank you. I appreciate those comments, Dr. McHugh, and I want to clarify what I meant by that. I agree with you 100 percent that there's no way to really delve deeply into what I think conceptually without specific examples. So I think specific examples are invaluable. All that I meant was that I hate to see — and the truth is I can't imagine this happening — a commission formed in order to respond to a specific example — and, for example, public health research as its mandate.
To use examples to help clarify its thinking and say, okay, here's the data on condoms from here and here's the data on condoms from here and here's the data on condoms from here and here's the data on interventions in democracies and here's the data on interventions in human-rights-compromised places — those are, of course, are the kinds of thinking that both help us get clear and help us move forward. So I agree with you completely.
CHAIRMAN PELLEGRINO: Thank you very much. If there are no further questions on this topic, let's reassemble at ten minutes of the hour for the last session of the afternoon.
SESSION 4: NATIONAL ETHICS COMMISSIONS: LOOKING BACK AND LOOKING FORWARD
CHAIRMAN PELLEGRINO: We're going this afternoon to take advantage of the fact that some people who have been in the trenches have decided that they'd be willing to help us a little bit by reflecting on what they've heard during the day. And this means a limitation on time. We've agreed that each would have the same amount of time, ten minutes, and that should get us over the major issues, I would hope. And I hope that there'll be some chance for you to query them.
These are all experienced people who have lived through working with a council or a committee or commission or whatever you want to call it. So I'm going to stop talking. They're looking at me and saying "What he's talking about?" the time is so short. And I'm going to start with the person from the first commission.
MR. CAPRON: Thank you. It is a pleasure to be here. Ed and I have in common that we were the chair, myself, and the vice chair, Ed, of one of those commissions that Cynthia Cohen said did nothing because we were the frozen embryo caught up in the abortion politics of the Congress of the United States. So I'm here because I was the executive director of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. You see I'm going to go very quickly.
My assigned task was to be here for the three preceding sessions, to reflect on the exchanges, to use my commission experience as a touchstone, and to stimulate—these are not my words, these are your director's words—stimulate the Council to grapple critically with differing conceptions of the missions and functions of national bioethics commissions and the working philosophies of such commissions.
So I reached a few general conclusions based on what I heard today. There is a wide range of views on what constitutes bioethics. I heard—I think Alfonso suggested it is a subfield of philosophy and therefore proceeds according to a certain type of philosophical reasoning. Other people suggest it's a multidisciplinary field.
There seemed to me in the exchanges from this commission, from our guests from France and England, who I think may have departed now. No, they're still there. No, there's Hugh . There seemed to be actually a great deal of satisfaction of each with their own way of doing work, and I think that is a natural human tendency. It also perhaps suggests that if there are successes and failures in each, there's nothing about the methodology that absolutely assures success or failure.
Skepticism was expressed in some quarters on whether it is useful to have governmental commissions and whether they have raised the right questions, but confidence was expressed in other quarters that they have. There is clearly, as the last panel showed us, a rich variety of issues on the cutting edge of science, health care, clinical medicine, public health, and environment that still need to be addressed, so that it's not going to be for want of issues that we would not have a future commission.
And throughout the day, the commission, the Council members and your guests spoke of the need to find ways to work and think internationally. So the major topics raised I've dissected under six headings. These are probably rather tentative and arbitrary, but I have a slide for each, so don't worry that you didn't get to read that slide.
As to missions, there were a variety of missions. Some, like the
French Commission, said that they were there to bridge the divide
between science and society. Others said they were there to monitor
scientific and medical developments—or a number of people said "advances,"
which doesn't seem to me a neutral word, so I tend to use the word
developments instead—and identify the issues that they will raise
for society. Particularly, Hugh described that as the Nuffield's
operating mode, looking out on the horizon and seeing what needs
attention and hasn't yet gotten it.
Your own council has the mission of articulating the range of views
on controversial subjects. And those who defended this said this
was the best way to inform the political process and policy making,
with the suggestion that once these views are out there, the democratic
process will operate. Others have said that the commissions worked
well if they provided guidance at the individual level—that is to
say, questions about how to live a good life, how to confront these
difficult decisions—or, at the level of health care professionals,
ethical standards that should guide practice. And, finally, clearly
a number of the commissions were charged and did operate by way
of providing recommendations to policy makers.
Now, under that, then, what are the functions or objectives of commissions? And I admit to drawing these categories from an article that you had that I wrote reflecting on the President's Commission, but they were all brought up today. Some of the issues, Carl Schneider suggested, all you're doing is solidifying the emerging consensus or, as he put it, the conventional wisdom.
You may in the process, if you do it well enough, lay the issue
to rest. That is to say, it stops being a major issue of controversy
and people say we have an idea of how we're supposed to be handling
that. But I don't think anyone thinks that that will quiet all the
ethical concerns, and you would certainly not write the final commentary.
Indeed, one of the areas in which the President's Commission I have
always thought did that was in our report on defining death. And
yet, as your own report on that indicates, twenty-some years on
it is worth looking at it, addressing the remaining or the revived
ethical concerns, the analytic and philosophical concerns, and providing
a new analysis of what's at stake and how it's resolved.
There is a watchdog function. And not very much of this came up today, but there was a suggestion by several people of this role, particularly I think in the French Commission, and the President's Commission was given that responsibility as to the federal execution of the rules about research.
And to take small issue with Carl Schneider, I think a number of the commissions, including the President's Commission, did examine and did publish reports on the degree of research risk, what harms. The major such report done by the National Commission actually concluded that most risks of research were like risks of ordinary life.
The President's Commission, taking on the regulatory framework,
said it is very difficult for researchers and research ethics committees
to operate with 28 different sets of rules from different departments
and agencies. We recommended successfully that they all be put together,
and we have the common rule. I suggest that that has lessened the
administrative burden and made analysis at least somewhat more sensible.
Then there is a function, a crucible, in which issues come in and boil up, and that process can identify the underlying disparate views, sometimes offer some correctives for obvious defects in reasoning or lack of communication, and articulate the implications of policy and ethical behavior. And sometimes, as I think it was Cynthia said, issues end up going to the commission as a dumping ground.
They take difficult issues out of the political arena, off the
back of the President, out of the Congressional committees where
they are a lightening rod causing problems, and they put them with
a commission which will have time; and maybe in that time the issue
will become less controverted. If it doesn't, at least the commission
absorbs the controversy instead of whoever else had it before.
The question was raised throughout the day: Can these functions
be better served by other means? And I think we have to take note
of points that were made, such as using National Academy of Sciences
committees (much more focused membership, much expertise there)
and a few bioethicists.
You look at organ donation? Have Jim Childress there. He's the
bioethicist. But then you have a lot of people who know about organ
donation as well. Also, Hugh mentioned in Britain with their separated
or spread-apart forms of ethical review, a lot of reliance on the
BMA's ethics committee. And for professional ethical norms, why
not have it with that committee rather than with a governmental
Then the question was raised — might we need coordination
across the topics? And again, the Nuffield achieves some of that
by having specialized working groups but having members of the council
on those groups and having the chairman of the working group on
Question of influence. How is influence measured, a number of people asked. Is it press coverage? Some people mentioned that. The Nuffield mentioned the number of the web downloads. Or is it only through adoption of policies?
A number of factors were cited as relevant to measuring the commission's impact: its connection with policy makers; will you have more interest from the chief executive and from agencies if you have liaisons appointed? And the President has actually been involved in the process of getting the commission started. Does the commission have action-forcing power.
Both the National Commission and the President's Commission had
action-forcing power, saying they could say to an agency this is
what you should do. The agency had to publish the recommendations
and respond within a given amount of time either accepting or rejecting.
They don't always do it, but that impetus is there, and there are
others with real power who can then say to them, "You're not
following your mandate." That, however, usually requires legislation.
And connection to legislators. That can be either because they
are authorizing agents for the commission or they're the objects
of the reports and hold hearings on them.
Another way of having influence is to have continuity. Both the national French committee and the Nuffield have existed for decades, and they developed a reputation by the quality of the work that they do. And the quality in and of itself of any commission gets to be a basis for having influence if you get respectful comments from the chattering classes.
Clarity of presentation, including presentation which is intended
to reach the educated public — to take people who have an
interest in something and express things in a way which is sophisticated
enough to satisfy the experts but is clear enough to be comprehended
by the public.
And finally, influence will certainly be more likely to come about
if there is relevance of the reports to practical problems facing
society as patients, professionals, and citizens. And a number of
people suggested that while you may be advisory, you're not academic.
That is to say, you should be policy relevant and not purely philosophical.
Questions of organization as they affect commissions came up: the members and chairs, who appoints them? A department, the way the National Commission was? The president, like a number of the successive commissions? Or the Congress, like Ed 's and my experience with the Biomedical Ethics Advisory Committee.
Are there categories of membership? Yes. In most of these to try to get breadth of scope of knowledge. But that does not mean that they are representatives of particular constituencies. They don't have reporting-back mechanisms to those constituencies. And there was some challenge to the notion that people are unaligned. Can they ever be unaligned from the views that they hold? Would you expect anybody to be able to operate that way? And there was some exchange over the difference between that and representativeness.
This question of independence and connection: Obviously connection
is good because it gives you influence, but then does it lose you
the necessary distance to be able to disagree with the people who
appointed you? And a little bit of exchange about commission and
staff relations, the relative expertise of each group and who produces
the reports, the staff or the members.
Method of working: Here questions came up about agenda setting.
Who sets the agenda? Is it the appointing body? Is it policymakers?
Is it the commission itself? Is it somebody else? Are there criteria
that are used, certain topics that are within our remit and others
aren't? This question of duplication. Rebecca just mentioned the
issue of ripeness. Is something now ready either to come back to
or for the first time? Is it ready for discussion or is it still
Deductive versus inductive and the—many of the commissions—there was a quotation about the work of the National Commission—I think it was also true with the President's Commission—were fairly pragmatic bodies. They try to engage in defensible reasoning from which principles could be derived rather than setting it out as a deductive model.
In any case, the obligation to articulate ethical reasoning was
mentioned, and I've already mentioned the question of what is the
field. Likewise, in terms of the method of working, are you aiming
for, a consensus or just a range of opinions?
In terms of dissemination of results, what are the appropriate
mode and timing of distribution? It seems to me—and here I'm drawing
on my work with the President's Commission: It is important to complete
work early enough to allow for follow-up with these commissions
that end up being time limited. We had success, for example, with
Splicing Life because it came out a year and a half before
we were done. There was a series of congressional hearings, and
in the end the recombinant DNA advisory committee was broadened
to include human genetic transfer.
We did not have the same success with Securing Access to Health
Care, an important report which contradicts several people
who said commissions never look at issues of health care and access.
You all are looking at some of these issues yourselves now. But
we did that. Unfortunately, it was done toward the end of our time,
and the same set of hearings could not be held.
Obviously, you have done a great job in publishing your reports
in print and electronically and you've done a nice job of having
an ongoing web presence for previous commissions.
It's also possible to work with congressional committees, federal agencies and law reform bodies. For example, Defining Death, obviously done by the President Commission with the National Conference on Commissioners on Uniform State Laws; Protecting Human Subjects, done by working with the Department of Health and Human Services; and likewise Splicing Life, with the hearings before then Representative Gore's committee.
My own sense listening to things is that follow-up may be more
important than dissemination, and that means that follow-through
planning has to begin when the commission's agenda is established
and amended. And I've developed what I call the HEARD model. That
is to the say that there's a Heritage, what issues you inherit and
are you bequeathed; the Environment, how familiar the issue is or
how novel; the urgency and the controversy; the Audience, let us
say professionals, public, peers, public officials and the press;
Response, what is your response? Do you give information, standards,
programs, regulations; and the Dissemination, the question of the
mode and timing.
Could commissions do better? Yes. They certainly can, and there's
a lot to critique. I think that they have had some success. And
if they want to be heard, I think they have to avoid being too academic.
They have to—they work best when they see their own work as part
of this continuing chain. Nuffield is an unbroken chain. The French
committee is an unbroken chain.
The American chain, we didn't hear here today from the National
Commission, although they're not all dead, so I wondered why they
weren't here. But there's a chain going back to 1974 in the National
Research Act which established the Commission.
They have to understand the topical setting of the subjects that are chosen, be clear about who is expected to read the reports and about what responses or reactions you want from them; and when and how to distribute is determined by the foregoing: what's the audience? What do you want them to do?
And so I think the follow-up has to begin at the start, not the end. You all are perhaps reaching the end of your work with your charter expiring in six months. But I hope you will have some of these things to pass on to others. Thank you all very much.
CHAIRMAN PELLEGRINO: Thank you very much, Alex . Ruth? Yes. Fire away.
DR. FADEN: I have the advantage in some respect in following Alex because some of what he said I was going to say, and he'll never know how brilliantly I was going to say it.
MR. CAPRON: In comparison to.
DR. FADEN: In comparison to. No, actually it's because Alex said it so well that I'm just going to quickly edit as I go by.
Part of our remit was, obviously as Alex pointed out, to stay all day, to listen and to respond, but also to give a little bit of history in terms of looking back. So I'm going to do one minute on the Advisory Committee on Human Radiation Experiments, which Cynthia didn't talk about.
But as a segue into what I want to talk about, the first thing I want to talk about in terms of reflecting on the day's experience has to do with the social functions or types of commissions, and Alex has already addressed that.
I'm going to do a slightly [expanded] type of topography, but I
think it is helpful to think about this council and other commissions
in some sort of a wider context. I then want to say a few words
about government structure and the architecture of commissions,
particularly ones that are government commissions, unlike the Nuffield
Council, which as you pointed out, doesn't have to locate itself
in any kind of democratic or government structure that relates to
the larger legal context in which the commission is situated.
And then if I have time, a couple of words on structuring commissions for success, which I think is an underexamined question and I think has something to do with what you were saying, Alex, about from the beginning thinking about how you're going to orchestrate the response and what counts.
So first of all, in terms of the different functions or structures of commissions, the commission that I chaired was in 1994-1995. It was created by President Clinton, and it was very different from the other commissions in following respect: It was created in response to what looked like the brewing of a major national scandal, and the scandal had to do with increasing allegations in the press that Americans had been used without their knowledge, without their consent in secret human radiation experiments from the 1940s through the 1970s. That was the allegation.
Now, at the time I didn't do this, because that's what you do. You just go to work and you don't think about it. But in retrospect and sort of almost to the end of this, I started looking at the political science literature on presidential commissions, which are a particular beast somewhat different from congressional commissions and so on.
And what I learned was that we were in part a species of commission
that is sometimes called the "disaster" or "scandal"
commission. So this is a commission that's created when something
terrible has happened and there is a determination that a credible
sort of arm's-length entity needs to be created, credible with the
public, to discern, to establish, to investigate what actually happened,
report back to the general public.
And so the examples of this, the commission that was set up after the Challenger disaster, after Three Mile Island, the Kerner Commission perhaps in some respects, the most dramatic, and then most recently the 9/11 Commission. These are all commissions that are set up because something terrible has happened or it is suspected that something terrible has happened and there's a view that the government can't investigate itself at least directly, and so you set up this arm's-length commission.
Always linked into these commissions, however, is a never-again function. So there's a piece that says go and find out what terrible—if something terrible happened, tell us what in fact happened, tell the story, make recommendations about what response there should be if, in fact, something bad happened in terms of compensation looking backwards.
But looking forward, there's always that line that says "and
then make recommendations so that whatever terrible things you discovered
won't happen again." And that was the structure of the commission
that I chaired that we participated in and that took us in directions
that I think the administration and, frankly, we did not foresee
both with regard to oversight research involving human subjects
about which I might say something later and also about the relationship
between science and the state, a territory that had been relatively
underexplored and still is to some extent in bioethics.
So that's one type of commission and that was the type of commission that we were. By definition, those commissions are very time limited. There's a need on the part of the public to get the answer quickly. You've got a month. You've got 18 months. You've got what looks like initially one subject and one subject only. It, of course, expanded. 9/11 ends up looking—the 9/11 Commission essentially takes our whole national security establishment to task and so on, but it starts out as a very particular thing.
Other kinds of commissions that—the way I would structure it and
the way I've come to view it very similar to the way Alex put it
forward. There are commissions that are set up in response to contentious
or challenging issues, often challenging social, moral, or political
issues, often longstanding ones, and they're usually of two types.
One is the type in which there is an earnest desire to get back
recommendations and findings based on which there will be action
or response. The other is what Cynthia and now Alex have used again
to be the dumping ground. We will take that contentious, challenging
social, political, or ethical issue, and we'll get rid of it by
giving it to a commission that will deal with it in some responsible
way that we can ignore.
Okay. Generally speaking in terms of both of these two types of commissions and the first type as well, there is an expectation that there will be findings and that there will be recommendations. That's the structure of a scandal or disaster commission. We are supposed to come back with findings and then come back with recommendations. But also it is the structure of commissions that are being tasked to address particular contentious issues or challenging issues that when it's set up that way the intent is to get back responses that could be presumably useful from the standpoint of moving the public policy issues forward.
Some political scientists take it that the mark of success or the gold standard of success for those kinds of commissions if they're presidentially appointed is the extent to which the president pays attention to the recommendations of the commission. And there are many, many things we can talk about as to what would constitute paying attention by the president.
Now, there's a fourth function. There are four types of commissions and I would—I think very much of great interest to me in terms of this particular council. I remember an exchange I had with Leon when it was first set up, which is one that from the very beginning has as its remit—say the first two of the three remits that Hugh was describing the Nuffield Council committees and working parties have.
And that is the function is to identify and to articulate moral
concerns or social concerns in this case around science and medicine
and then to promote public discussion and reflection. So this is
a commission whose intent is not to come up with recommendations,
not to come up with findings as much as to come up with an analysis
of the issues that can serve to elevate public debate and deliberation.
I want to get back to what that exactly would mean if I have time. So what does it mean to say that you work towards the end of elevating public conversation and improving the deliberative process for society as a whole? How would be know that?
It has a lot to do, it seems to me, with some of the things that Nancy mentioned about the role of community and public engagement. Are we talking about one-way education? Are we talking about an analysis structure that allows informed—the informed public to better debate and reflect on the issues? Are we talking about ways of—that extend to eliciting the public's views about concerns? And are we talking about public engagement, which is a much more aggressive way of attempting to elevate public conversation. So that's—in terms of the typology—I'm sorry. I wasn't as technically adept and don't have a slide to show you that. I was doing it as we were talking.
A couple of comments on governance and architecture issues. I don't think you can separate identifying the most appropriate governance and architecture for a presidential or national commission from the commission's remit in social function. So I think it's terribly important to get a good fit. And the question is, do you really know at the outset what kind of commission you are or are supposed to be?
I think some of the problems, not just in the context of bioethics commissions but commissions generally, is that there's ambiguity about exactly how you're supposed to understand your remit and, of course, you can have multiple remits. So some issues to think about also have come up in the course of the conversation today and that Alex mentioned that I think bear repeating.
One is to think about the difference between standing committees that have continuity and time-limited committees and commissions. And there is a lot to be said—we heard from the French experience but also the Nuffield, which is a very different way of thinking about a structure that extends over time across political administrations, although you had that experience a little bit and could talk about it.
But just in general, what are the differences in terms of what is possible or not, what is appropriate or not, what is the right remit or not for commissions that come and go versus the notion that we might have a standing commission of some sort and what would be the right role for a standing commission.
So, for example, insofar as there is a watchdog function, insofar as there is an oversight function, one would think that that kind of function for a national commission—maybe it isn't even a national commission—really belongs in something that extends over time.
We're having conversations just beginning in this country about creating a federal reserve board for health modeled after the Federal–a federal health board modeled after the Federal Reserve Board and the notion that this sort of a structure, which would deal with some extraordinarily difficult moral issues with regard to coverage decisions and finance decisions, would need to be insulated from the political process.
It would need to have a structure that would allow it to continue over time and to not suffer from the interruptions and the vagaries that come as political parties rise or fall in their control of Congress or the administration.
There's the issue that has already been discussed here a lot about representativeness and whether members of commissions are thought to be representative of groups or entities. The language that I had preferred to use for this would—is to establish stakeholder committees. That is, commissions or committees that are put together to represent particular stakeholders in whatever the territory is that is at issue for this commission or committee versus expert committees where you put people together because you have a view about a certain range of expertise that needs to be present to advance the issues further versus committees that are generally put together with no forethought at all. Right?
So we are very fortunate because the architects, as it were, of the Advisory Committee on Human Radiation Experiments in the Clinton administration at that time had come recently from the experience of OTA, the Office of Technology Assessment, where there had been a lot of lived history and thinking about how to put together diverse expert committees. That was the model of which it operated.
That said, we had a public member. I'm looking at Jonathan in the
back. We had this great—we had one woman who was appointed to the
committee to represent the American public, which is like saying
the remit to educate 300 [million] Americans is a little daunting.
The notion that one woman should represent—one person should represent
300 [million] Americans, but that was her role. She was the designated
representative for the general public.
Fortunately, she was a woman who had a great sense of humor and bore her responsibility with equanimity and, in fact, she did basically what Hugh was describing. She functioned within her judgment and she responded to the issues before us as we all did: with our own values, our own judgments, and our own good or bad sense, our own practical reasoning.
There were the issues of resources. I just want to say two more things and then I think I need to stop. Resources are key. I don't really know what the resources were for the President's Council. I don't know how your funding—how much funding you had and whether you were satisfied with your funding in the early years or later years or not. But resources—
MR. CAPRON: No comment.
DR. FADEN: No comment. All right. Funding can make a tremendous amount of difference. And, again, this good fit in terms of structuring of commissions for success, if you give a remit to a commission that doesn't have the resources to responsibly pursue that remit. So let's say that eliciting the public's views and engaging the public on issues before you is part of your remit. Well, if you don't have the resources to do serious systematic public engagement, you won't be successful in regard to that part of your remit.
Also, if you've got diverse enough topics and issues, the working
party's model that the Nuffield Council uses makes a lot of sense,
and again that is like the model, as Alex points out, the IOM [Institute
of Medicine] and NAS [National Academy of Sciences] and other groups
use. You put together committees that—where the expertise is appropriate
to the particular issue at hand.
When you have standing commissions and councils, resources become a real issue in terms of getting the right people around the table. And although you can take testimony and can hear from the best, you're not deliberating with them in a regular, ongoing fashion, the best in that particular area. It's a problem.
Should commissions and committees have the resources to conduct
empirical research? A very important question. To do fact finding
of its own? Depending on your remit, you really can't pursue what
you need to pursue unless you have those resources. So I will stop
here with—I want to go back to that in just a minute and tie it
back to Carl 's comment.
But with two other things, independence is key. Right? And this has been mentioned several times. The independence of the committee and the commission is key. But the question is independence from what? So the obvious one is independence from influence from government. If in fact you're a presidential commission or a congressional commission, independence from Congress or independence from the White House.
But really, how independent are you? If you're a commission that
wants to live to see another year, another two years, another three
years, the issue emerges how do you negotiate your relationship
with the White House or Congress. How contentious can your reports
or conclusions or findings be? All kinds of issue of that sort.
And then there's also issues of independence from other stakeholders
besides the government agency to which you're accountable.
Finally, in line with that, accountability, impact, and relevance. I won't say anything more about that. We've got Alex 's wonderful HEARD out there to think about it and discuss further and I want to leave time for Eric .
One thing about being able to conduct empirical research, however.
Carl, you really threw down a gauntlet in terms of your analysis
of the failure of commissions with regard to human subjects research,
and I think that your analysis needs to be sort of disaggregated.
The critique about the failure of the current oversight system with
respect to human subjects, I would completely share. [I would] not
necessarily explicate it the way you do, but I think the time is
right to recognize that we need to rethink how we do things in very
But I don't accept the part of your critique that says that national
commissions or presidential commissions have not been helpful in
pointing out that problem and I would argue they could be even more
helpful. One of the issues we have, the point you make, is that
we don't have data. We don't have data about how well the system
It's extremely difficult—I've tried to do this through a presidential commission. I've tried to do it outside of government. When you're within a presidential commission, you have authority and power that you can use to get information that you cannot get otherwise.
It's just extremely difficult. So I was part of an enterprise with the advisory committee. We were able to compel, essentially, funding agencies within government and essentially manipulate universities to give us data information that they would not otherwise have given us. And that's a whole other story.
Separately, I was part of a consortium that tried to do a cost study, tried to figure out how much the IRB system actually costs academic and non-academic research institutions. I can tell you we struggled. It was a horrible experience. We got the roughest possible estimates, and it was in large part because nobody had to tell us anything, and very quickly universities and private research IRB kinds of places figured out that they might have some interest in the findings and not want to know or, you know, be part of a process that showed how much, in fact, it did or didn't cost them.
So there's a place for an empirical and fact-finding and investigative role. Whether it should sit with national, presidential, or congressional commissions, I don't know, but it needs to sit some place. And I'll stop there.
CHAIRMAN PELLEGRINO: Thank you very, very much, Ruth . Eric?
DR. MESLIN: Dr. Pellegrino and Dr. Davis, thank you very much for the invitation. I'm going to do three things in ten minutes. I want to give you my take on the issues addressed today, many of which will be similar to what Ruth and Alex have done. Secondly, I'm going to describe how the National Bioethics Advisory Commission addressed those same issues of which I was the executive director. And then third, I do want to put out a little bit of a list of issues that weren't addressed or at least weren't explicitly addressed today that are sort of my free offer to you to take on.
There are three categories of issues that I think were addressed today. The first were methods, models, and approaches; the second one, clustered under a topic that I'd call public representation or engagement; and then the third one is impact. Each of those have subcategories.
With respect to each of them, I'll just go through them relatively quickly and not dawdle on the ones that have already been commented on by others. Of the many issues that I heard today discussed around the topic of methods of work, the consensus issue was most frequently offered. If we were keeping track, I sort of took about 25 different notes that that issue of consensus versus rich diversity versus some other method of approach was discussed quite often.
I've got to tell you that—and I've published on this, so my views are widely known. I think the critique of consensus on commissions has a bit of work to do in part because there are claims made on both sides of this debate that are on the one hand quite helpful because we can't just throw out a word like "consensus" and yet on the other hand might often rise to the level of being pejorative as in, "Oh, you're just doing consensus, whereas we're just doing . . ." something else.
I'm actually—and I'm going to make a little attempt at achieving consensus and see if it works. I don't think that consensus is either a destination or a required mode of transportation. In some instances consensus happens, not because it's a goal to be strived for or because it is an agreed upon method by which agreement is reached, but it occurs.
And I'll give you a couple of examples of that from NBAC using the example of another methodologic dispute that I think has been discussed here between whether we do bottom-up or top-down bioethics. And you might call that the principles versus practice or cases versus theory. It goes by many different names.
Harold Shapiro, who is the chair of NBAC, and I outlined our views on some of NBAC's early work, sort of two or three years into it, in a paper that we wrote for the 20th anniversary of the Belmont Report Conference that was held in Charlottesville. Some of you were there.
And we carried out a little report-by-report assessment. You can read the paper if you're interested. But what we basically concluded was that some of the NBAC reports more easily identified with one approach starting with principles and moving down to something else. In fact, the best example of that was our report on research involving persons with mental disorders. In fact, we wrote early in that paper that "NBAC's views about respect for persons, beneficence, and justice are squarely in the tradition established by the National Commission nearly 20 years ago". Those words were published words.
So we went to great links to sort of talk about principles. Contrast that with the report on cloning, NBAC's very first report in which the commission reviewed the various philosophical approaches around the topic but learned very quickly, not surprisingly because of time constraints, that they weren't able to arrive at a set of recommendations solely through a process of philosophical reasoning and deliberation. In fact, if you were to interrogate two or three of the commissioners, including perhaps Professor Capron, I suspect you would get different reasons in their mind for why they came to the conclusions that they did that resulted in recommendations to President Clinton .
A second methodologic distinction that I heard discussed today
was the role of education versus policy advice. And I think everyone
could identify with this dilemma of whether one can do both things
well within the ambit of one group. I'm going to mention later on
how to assess impact, but suffice it to say the ongoing educative
value of commission transcripts, working papers, commission papers,
draft reports that had yet to be finalized, and final reports provides
a voluminous literature from which many can and still do learn today.
If you think that education is simply unidirectional from here
to someone in Congress, then we're obviously not thinking about
what education means, let alone training, an entirely separate but
related feature. I've actually had the pleasure of teaching about
stem cell research ethics to high school students in the United
States using the President's Council on Bioethics literature and
NBAC as a compare and contrast. It's a fascinating pedagogical strategy,
and I would submit that the results of both of those commissions
are very valuable from an educational perspective.
With respect—and this is different from the policy advice function that Alex has referred to and I'm not going to replicate for reasons of time. With respect to a selection of topics, NBAC lived this dichotomy of being assigned a set of topics generically in its executive order and charter and then actually being given topics when a version of Ruth 's—what did you call it? It's a great name for— disaster planning. I don't know if Dolly was a disaster, but I can tell you that in private conversations with Harold Shapiro —
DR. FADEN: Crisis.
DR. MESLIN: Crisis.
With Harold Shapiro, it's no longer a private matter. He related
to me that he agreed to become chair of NBAC when he discussed this
with the president on one condition, and that there would be no
emergent issues for the commission to address within the first year.
He wanted the commission to start to get its feel and understand
how to work. Well, that was thrown out the door in— when Dolly was
announced to the world.
So this distinction between responding to issues that you have been given versus identifying those on your own is actually a delicate balance that I think all commissions from the National Commission on have had to address. I actually have just figured out that NBAC equally divided its six major reports between those that it had been assigned to undertake. Those were cloning, stem cell research, and research involving human participants, the latter being within its initial charter. And a second set of three reports, the Report on Human Biological Materials, the one on mental disorders and the report on international research, which arose from the commission's own priority setting activity.
Now, this priority setting exercise, which took seriously the commission's
charter, made it clear— and I think this was a question asked of
Nancy Kass when she was here and she was politely trying to deflect
it, but I thought her answer was quite nice-how do we decide what's
important? Or as Professor Dresser has now been attributed to calling
this—I like this version of "ripe." It sort of has a fruitiness
to it or a wine bit to it. And I would encourage wine at commission
meetings, Dr. Davis, if you could discuss with those who are revising
the Federal Advisory Committee Act.
Now, we—I suspect you do too. You, the President's Council, received
many e-mails, letters, and telephone calls asking for particular
topics to be placed on your agenda, some by people who had longstanding
interest in a topic, some by people who are very serious commentators
and wished finally that a presidential commissions would look at
this. We could only address a certain number of issues for reasons
very similar to what Marie-Hélène indicated and also
Hugh indicated. There's only so much time, only so much staff work,
and only so much money.
With respect to public representation, and we don't even have a good language yet for talking about this issue. I've just divided it into two different categories, which is inelegant to say the least. One is the commission membership version of the public representation topic and the other is the actual public participation in the process itself.
With respect to membership, much has been made, including by me
in a Hastings Center quickie, about this council before—as it was
starting about the difference between NBAC's charter and the President's
Council charter with respect to public membership on it. We explicitly
included public members. This one did not. And a lot of to-ing and
fro-ing and puffing of chests occurred as a result.
Well, I'm here to tell you if you didn't already know that the two designated public members on NBAC were first the president of an advocacy organization and the second was a principle in a biotechnology firm, neither of which I think a reasonable person, including the one that Ruth was mentioning that represents 300 million Americans, could sensibly be considered the, you know, the gentle person on the Clapham omnibus, so to speak.
I suppose a good argument for reproductive cloning would be to clone that reasonable person that we're all looking for and place her on every one of the 900 federal advisory committees, and we'd be done with it.
Public participation. I'm not going to pull one of those critiques that will come back to haunt me like Al Gore inventing the Internet, but I do think that NBAC was the among the first commissions that took seriously its obligation to use the Web and to use the Internet.
We had long discussions with general counsel at HHS on such things as when we would put our transcripts—you never thought "transcript" would be in the transcript of a meeting, but there it is—on the Web. That was sort of like genome sequence discussions. Would it be within 24 hours? Would it be within 72 hours? Would it be within, you know, a month? These were difficult decisions that I'm sure only maybe Dan and Yuval can appreciate, those of us who are executive directors or staff directors of commissions, the nuances. But it was very important, putting something on the web immediately gave it a gravitas that having to wait for something published later on in the federal register didn't.
Let me conclude with my—the biggest list of all, and that's impact because I think the elephant in the room today is claims about how to assess and evaluate the impact of these groups. Again, I've tried to do a very rough subdividing. Like Ruth, I was typing furiously in the back of the room and couldn't pull off the slide show that Alex did.
But I've divided my categories of impact into three different ones, all of which recognize that impact comes in different forms, involves different time horizons and involves different types of metrics, some of which, like the instruments that didn't exist when we said we'd map and sequence the human genome, weren't present to us then and probably still aren't present to us now. We're going to have to invent them.
The first set of impacts—sorry about the word—are what I might call stimulus or push impacts in the interest of the current administration. When NBAC wrote its report on human biological materials, the fact that it wrote that report stimulated a very active discussion on such issues as the identifiability of genetic tissues—of genetic information in human tissues. That was not a robust discussion in the bioethics literature, the FDA, or anywhere else. It elicited a response from the FDA, the NCI, and lots of public and private organizations.
Our stem cell recommendation that's already been eluded to generated a lot of reaction, some of which we didn't anticipate. Like the president issuing a press release on July the 14th saying that he rejected the recommendations that we hadn't submitted yet. This was an interesting form of impact and caused—I can't—I mean, I'm still going through therapy because of it—a lot of hand wringing on behalf of commissioners and the staff.
Again, not taking credit, but I do think that in some small way
NBAC's discussion about the oversight of the human subjects system
led to or contributed to the transition of OPRR to OHRP. We had
very long discussions about this and it happened during our watch,
so there's at least an associative impact as a result of that. Our
discussion led by Alex Capron in our report on international research
led to an important debate about the equivalent protection provision
of 45-CFR-46, which gives the secretary particular powers to talk
about other country's guidelines.
And I think our work on international research stimulated discussion
and action by many around two of the most controversial provisions
of the Declaration of Helsinki at that time. Indeed there was some
discussion that many groups wanted to wait for NBAC to complete
its work before they weighed in on the issue. There was a kind of
timing phenomenon. I had long discussions with Sandy Thomas, Hugh
Whittle 's predecessor at Nuffield, who was pleased to have us finish
our reports that they could then take up their report. This is an
important type of impact. WHO, CIOMS [Council For International
Organizations of Medical Sciences], and many other organizations,
including Public Citizen, weighed in on NBAC's work.
A second category of impact is what I call the reminder or "nag"
kind of impact. The report on mental disorders which I had mentioned
earlier had an impact for a different reason. And it had the effect
of reminding the federal government that the subparts that existed,
only four of them, one of which was the basic rules and three of
which referred to special or vulnerable populations, did not have
any coherence to them.
Why those three? We know that there's a history to them, but why not others? Why isn't there a provision for the aging patient, the young patient, the economically disadvantaged patient, or the patient who is lacking capacity? Compensation for research injury, privacy, harmonized research policy.
Let me just close, Dr. Pellegrino, with these two remarks on areas
that I don't think are discussed by commissions or has not been
discussed today. The first is the importance of a commission's convening
power. Like it or not, although you're all members of a presidentially
appointed commission and the staff have senior executive service
status, I suspect that Yuval will mention Dan understands that when
you make a phone call from a place that has a presidential seal
on the letterhead, people return the phone calls an awful lot faster
than they do normally. People don't return my phone calls as much
now, and it's kind of sad. But it was an important point about convening
Reporting relationships. Ruth has spoken about and Alex has spoken about staff- and commissioner-led roles. I do want to mention one thing, which might be a very appropriate transition to the last speaker. You should know that Yuval and I have had some very nice and enjoyable conversations over the last five or six months about the transition from one commission to another. We sort of lived in both eras. I congratulate you, Dr. Pellegrino and Dr. Davis, for having some of us on who worked for previous commissions come to you because this is a mini type of transitional activity from one to another.
No one gave me any materials from prior commissions. Were it not
for Ruth Faden's commission's work, NBAC would not have known what
the history of some of those issues were. But there was no formal
debriefing, no formal transition, and I very much appreciate the
opportunity that Yuval and I had just to sort of—you know, guys
sitting around and talking about the good old days. But I think
this is a topic that you need not let go unnoticed.
Last, and then I'll sit down. Bioethics commissions now seem to be as much an instrument of science policy advice as they are about bioethics policy. If that's the case, then you need look no further than a memorandum that President Obama signed earlier this week that talks about science and science policy and science integrity as an instrument of national and domestic policy. So bioethics commissions are going to have to think a little bit more about those as well. Thanks very much.
CHAIRMAN PELLEGRINO: Thank you very much, Eric . Yuval?
MR. LEVIN: Thank you very much. It's a great pleasure to be here and I appreciate very much the invitation, and it's wonderful to be on such a distinguished panel. Eric is too modest to say so, but he was in a way an exception to the rule he laid out at the end. We didn't have a formal transition, but he was immensely helpful to us in the transition. And, as he says, we've continued to talk about these issues since.
In a way I want to pick up on where he ended, which is on the way
in which bioethics issues—what we think of as bioethics issues have
changed over the years and what that has meant to the work of bioethics
commissions. This invitation gave me an excuse to look again through
some of the wonderful work of the early commissions of the National
Commission and the President's Commission, extremely valuable work
and we all ought to recognize how much there is to appreciate.
And one of the things you notice is that what they were called to do was rather different than what we were called to do and in a way what NBAC was called to do and had to do. Bioethics does a lot of things, but I think that from the point of view of public bioethics commissions there are two things we can focus on in particular.
One is to act as a mediator between science or medicine and society. To mediate between medicine and society is a lot of what bioethics did at the beginning. It emerged from concerns about medical paternalism, about the treatment of patients, about the place of physicians in society, and saw its role correctly, I think, as fixing the relationship between medicine and society.
A lot of what bioethics does now—and again, it's a matter of what's emphasized. Both of these elements were present in the beginning and both are present now. But a lot of what's emphasized now, especially in public bioethics, has to do not with mediating between medicine and society but with clarifying a debate or a dispute within the larger society about medicine or science.
And these, in fact, turn out to be very different. And in defining the role and the work of a bioethics commission or a public commission, they mean very different things. And I think that has to do with the subject that kept coming up today, the question of whether you seek consensus or not, the question of just what it is you see as your role.
There is a way in which this moment for bioethics commissions or maybe we can say the last decade or so has called for a lot more of the kind of work that tries to clarify a dispute that exists within society to help society think through a set of developments in science or medicine that raises tensions, that creates problems, that creates disputes that draw on existing differences in our political culture but that require an understanding of science and an understanding of what the question is we're called to deal with that experts can help to deal with.
Many of the most difficult bioethical questions that become policy or political questions now are not at their core technical or regulatory matters but truly moral questions. They're questions about what kind of being the human being is, what kind of a life that being should pursue. Certain kinds of developments in biology and biotechnology and medicine raise really complicated challenges to our sense of ourselves.
And one crucial goal, as I say, of bioethics is to help the public understand these question as they arise in their native, social, and cultural and political settings, not to translate them into a foreign language that only experts understand or to dispense with them like a kind of geometry problem. But to help the public understand what the issue is, what the arguments are, and to help people come to conclusions rather than to take over the debate.
The problems that these questions raise for our society are genuine problems. They have to be worked out by the larger society through its social and its cultural and its political institutions. And they have to be digested by people of very different world views who are going to come to very different conclusions.
And one role of the bioethics council in this view is to clarify and elevate the questions rather than simply to dispose of them. It's a view, I think, that draws on a particular understanding of politics in a democracy, on a sense that political, what me might think of as partisan differences, while they can easily get very carried away are fundamentally legitimate differences. They're not failures of understanding.
To approach this kind of genuine disputed public question with an eye only to a kind of expert consensus I think can easily disparage the question and disparage the people asking it and end up arguing that this kind of disagreement is just a function of ignorance or blindness. But that's simply not so—or at least it's not exactly so.
It's true, of course, that political disagreement, any political disagreement, is a function of our imperfect knowledge in part. We never see the whole truth all at once. We see only parts of it, and different people are inclined for a variety of reasons to emphasize with good reasons and good intentions different parts. That's what makes parties and partisanship.
The disputes between them are finally disputes about what parts of the truth ought to be emphasized. And these are serious disputes that deserve the aid of thoughtful and learned people. They speak to the question of the public good. No one has a grasp of the whole all at once and everyone has a case to make for why the part they think is most important really is. Why liberty might matter more than equality in some instance or why the family might matter more than the individual or why the health or some might matter even more than the lives of others or vice versa.
In any serious public dispute, each of these kinds of views will have a very serious case to make. And as I say, each will benefit from the work of intelligent and educated advocates to help to clarify it and to argue it out. Instead, too often thoughtful and learned people, public philosophers, and intellectuals seek not to inform these debates but to overcome them by reaching for a language in which they are rendered essentially meaningless.
In practice, I think that what this really does is render that work meaningless, is render the work of these public philosophers meaningless since it doesn't speak to the way in which these questions emerged, and especially if you do this in a public body that's answerable to the political society that has asked you for help to say that—to say essentially that the reason this has all come up is pointless isn't going to be very helpful and for the most part isn't going to be very true.
I think it's clear the design and the scope of this council that it is moved by this kind of understanding of the nature of politics and of the nature of the most prominent bioethical questions of the day and of the role of intellectuals like these members of the council in the public sphere.
It's very evident in the charter of the council, the executive order that created it. The order says that the council is to advise the president but not by transforming the bioethical questions that emerge before the country into technical or academic questions, but by helping the president and the country better understand these questions and the various answers that have emerged to them and their implications.
The charter of this council really is a kind of explication of this view of politics, I think. It describes a very broad scope, but it does not say that the purpose of the council is to resolve these issues. Its purpose is to clarify them for policy makers and for the public so that they can be argued and decided in the proper venues.
The council was certainly empowered to make recommendations and to have the members or the body as a whole express particular views. But the point was always the argument for those views. The point was laying out the positions so that policymakers and the public might understand them better. And the hope was that council members would help people understand their own views by taking these views seriously, by as Dianne Schaub said earlier paraphrasing Alexis de Tocqueville, I think, by seeing further than the partisans but not looking in a different direction, looking at public questions as serious questions.
This approach obviously has its benefits and its drawbacks. but
I think as a descriptive matter this is certainly the approach behind
the design of this council and behind the selection of the members
who were chosen to disagree, as they often did, much to the chagrin
of the staff...
And the hope was to provide a forum in which that disagreement could be had among people who thought about these questions, that thought through the issues and can articulate the competing position with knowledge and with depth. It's an approach to public bioethics that makes for a very different flavor in the council's report than what you would normally find in such bodies around the world and some of the prior American councils but that if done properly offers a way of taking politics seriously and respecting the character of our democracy and the difficulty of these questions.
It's not easy to do this well, but I think that on the whole, this
council has done it very well, which is a testament above all to
it's chairmen, past and present, to its members, past and present,
and I'll close by thanking the chairman and the members not only
for having me today but for giving me the opportunity to serve this
council in the past and benefiting from its work as a consumer of
its work later on in the White House. Thank you very much.
CHAIRMAN PELLEGRINO: Thank you very much, Yuval. And thank you to all of my colleagues and friends who were kind enough to do a terrific job, honestly, in a few minutes summarizing so much of what went on today and embellishing it in a way that I think is extraordinarily helpful. We're deeply indebted to you, especially for your patience and putting up with this particularly rigorous way of doing it. Thank you so much.
Well, it looks like someone wants to ask a question. Yes, Dr. Gómez-Lobo?
PROF. GÓMEZ-LOBO: This is really my question from the morning that's transported to the afternoon.
CHAIRMAN PELLEGRINO: We failed to forget.
PROF. GÓMEZ-LOBO: I really enjoyed all four of the expositions. I really learned a lot. I was unprepared for so much information and so much insight into—particularly into the positive aspects of all of these devoted public bodies.
Now, I want to address my question to Eric. In reality, it's a
question that I had planned to address to Cynthia Cohen, but I saw
her leaving so I said I'll hit Eric in the afternoon.
But let me preface the question, because in a way it's going to sound like a very narrow question. It's going to sound narrow, but I trust that everybody in the room will realize that it has broader implications. It has implications, I take it, for this idea of consensus. In fact, the—I'm been personally puzzled all day today about this idea. I mean, how do you reach consensus when you have convictions that are so different and opposed and contradictory on many of the issues?
One way to go about it would be to distinguish levels where, of
course, you can compromise. You can go into a consensus and then
say, well, but at Level C it's impossible. It would logically inconsistent
on my part if I did. And the specific question is this: Last night
I was reading Cynthia's Kennedy Institute of Ethics Journal article
from 2005 that we got in our briefing book. And I thought it was
fascinating whenever Leo Strauss appears on the horizon. That gives
me shivers because I'm not very partial to his views.
But I thought that simplifying a lot, in a way meant to present
the NBAC people like the good guys the President's Council people
like the bad guys in a way. Why? Because there's an argument there
that the first council went for this idea of overlapping consensus,
and that just sounds great. I mean, why should we as civilized and
educated human beings not go for overlapping consensus?
In fact, I would say we do that all the time. I mean, we couldn't live with each other if we didn't do that. But then I took a closer look at the specific point in the report on stem cell research and how that consensus was reached. And the consensus was reached–and I better quote because it's almost unbelievable. The consensus was reached by adopting an argument by Ronald Dworkin to the effect that people who hold inviolability of a human embryo do admit exceptions.
Now, that's the premise. The conclusion is therefore these people don't believe in that inviolability or that a fetus is a person or whatever formulation you like. Now, that's an non sequitur any way you look at it. I mean, it's an incredible argument after people who have been holding the inviolability of early human life have been discussing direct and indirect killing for what? Eight centuries?
So to conclude that the report had reached on the basis of that
argument the required overlapping consensus to agree—and I quote:
"It also is permissible to destroy embryos when it is necessary
to save lives or prevent extreme suffering," taking that as
a basis for the recommendation. And here's the question, the real
question. Wasn't there anyone in the NBAC who stood up and said,
"Wait a minute. This is really a very fallacious argument.
It really doesn't work. It's simply not true that you can infer
the mental states of people who would go on holding that inviolability
simply because of alleged exceptions."
I mean, traditionally anyone holding—anyone who has some sense
of the principle of double effect would say, no, they're not exceptions
at all. So the question is very specific. Wasn't there anyone who
stood up and said, "Wait a minute, this argument just doesn't
DR. MESLIN: Yes.
Do you want to hear more? Consensus is not unanimity. And in fact—I
mean, it's great that you asked the question. I'm smiling for two
reasons. One, this is, as physicians often swear by Apollo to their—those
who help them along the way, Professor Gómez-Lobo helped
me as a young graduate student at Georgetown, so I thank you. And
now you're putting me through the wringer again. I thought we were
already over that.
Yeah. I'll tell you two things about that discussion. And Professor Capron can also weigh in, being a member of the group that actually came—I was merely an executive director. But the answer to the question is yes. And there are two ways that I could describe it. One is I could encourage you to read the transcript again so you could see just who those commissioners were, what they said, what their level of comfort and disagreement was not only with the argument but with the final recommendations.
I don't treat this answer lightly because, in fact, there—it was among the most difficult of the reports that I was involved in. I was not involved in the cloning report; I came on after that. To talk to individual commissioners on their own about these issues and one—I'm thinking of one commissioner in particular who I think was the most troubled by the direction of this argument.
So the answer to the question is yes. Was there anyone? Of course
there was. There was, in fact, more than one. I think the question
you're also asking is, if that's the case, how is it that they could
sign on to a recommendation like this or an argument that goes like
You know, the quick answer would be they felt comfortable enough—I can't go into their mind anymore than you would like us to be able to—to come to that conclusion and did so in several ways. And here I'm going to extrapolate a bit and again, Alex, if you want to jump in, you're welcome to.
One is I think that as a procedural matter, the meeting that we held in the Riggs Library at Georgetown where we invited 12 scholars from different faith traditions to speak about their views. In fact, I think—is Professor Meilaender still here? Yes, he is—who helped us greatly at that—at that meeting and in prior documents.
Provided a certain degree—and I'm reluctant to use this word, but I'll say it anyway—degree of comfort in the minds of the one or two commissioners that I'm thinking of. It's not that I'm trying to protect their identity. I'm just simply—the point is not naming names; it's answering the question. But to hear this discussion at the level of clarity and commitment to these very questions that you're asking, Alfonso, I think gave a certain degree of assurance that the commission had weighed, considered not so much the Dworkin argument.
This wasn't take argument, take stem cells, stick stem cell to argument, and get conclusion. In no way, shape, or form is that the process. But, yes, there was an awful lot of deliberation. There was an awful lot of discomfort. I well remember an interaction between one or two commissioners and Father Demetri Demopolis, a Greek Orthodox theologian, who came to that Riggs Library meeting— I remember it like it was yesterday—who went on at quite some length expressing his own reservations and discomforts.
So whether or not there is a relationship between hearing the arguments of others and the level of comfort that provided these one or two commissioners with the assurance that they felt that their fellow commissioners needed in order to sign on, I don't know.
I'll say one other quick thing. In no way, shape or form was there any effort at arm twisting, at driving to consensus at all costs. There are several examples in many NBAC reports, including ones written by my colleague to my left, who wrote personal statements not at the end, not in an appendix, on the very page where the debated issue was raised in order for their views and their view or views or multiple views could be—could be reflected.
So I don't know if you want to add to it, Alex, but that's a quick answer for you, Alfonso.
CHAIRMAN PELLEGRINO: I will call on you, Bill, for one second. Eric, you may not remember. I was at that meeting. And I think if you look at the record, I stated unequivocally that there was no compromise on this issue so far as I was concerned, and I'd like to go on the record stating that clearly because some of my compatriots of the same persuasion—
DR. MESLIN: At that same meeting—
CHAIRMAN PELLEGRINO: —disagreed with me.
DR. MESLIN: At that same meeting.
CHAIRMAN PELLEGRINO: So I was, I think, the only one who held to that strictly and without compromise, and I think it's important to know that. Now, I'll ask for Bill Hurlbut, who wants to comment.
DR. HURLBUT: I really want to just extend what's being said here with an analogy, as I was thinking about it ever since the presentation this morning that if we look at the meaning of diversity or a variation of views, we have a really good analogy from the—from the basic biochemistry of our being, namely the diversity of our gene pool, which although we're not all identical it's a tremendous resource of variation for our species.
And yet it has to work as a unit. It has to have a kind of diversity of parts that's compatible with the survival of the whole. And that seems to me the key here. Somebody—one of my friends at Stanford said about the genome that we're packed for all kinds of weather. In other words, we survive as a species partly by generating diversity. Species have always done that from the beginning. Bacteria would produce thousands of slight variations, and one or another would survive. We've distilled it down into a more enduring individual who can think with a diversity of thoughts and a community that has a diversity of individuals with diverse thoughts of their own.
If life started out by surviving by mutation, it ended up by permutations of mind. And this strikes me as absolutely crucial in a body such as a bioethics council, where there is a combination of defense of a stable core of our humanity but the creative power that diversity brings that allows the transformations that are necessary for the changing weather of social realities and different circumstances.
And it strikes me if we look back with a thoughtful reflection of what ethics is, we would realize more deeply that the word gives us a clue. That—ethics, of course, comes from the fundamental Greek—you better correct me if I'm wrong on all this, Alfonso. But the Greek root is having custom or character, and it's tied deeply with the—even further with the Indo-European root with the word "ethnic." So it was something that sort of flowed up by its nature from who you were and what you were.
Ethical positions feel so fundamentally real to us. That's why they work in individual life and sustaining communities. But it also makes it so we can't understand easily why somebody else wouldn't agree. It's like—it goes all the way to bottom of us. "Why can't they see that it's true?" And it ends up, then, that we unfortunately misjudge one another, sometimes label each other's views as intentionally obfuscating truth or as ideology or as unscientific or something that doesn't bespeak respect to the diversity of views that are being expressed.
And so what I really want to say about this, there are two fundamental things that I think are extremely important in future councils. I feel like one of the best things we did in this council—have done and continue to do—is to respectfully seek what is common behind our diversity of views. And one of the things that I think we did best in the past in our work in this council was our white paper for alternative sources of pluripotent stem cells, because that was where we both understood there were irresolvable differences. Maybe if we'd had more time or something else, we could have resolved them, and maybe societies in the future will resolve them. But we couldn't.
So finally what we did was we understood that even within that diversity there was perhaps a space where they could be a creative third option, a solution that was at the core of our common concerns. And I think it's that which is the strength that we need to seek, a kind of creative, constructive resolution of some of this. Otherwise, we're just headed for an infinite playing out of the culture wars.
And I would wish bioethics could be a more constructive process. It's not that we should seek lowest common denominator ethics. It's that we should seek a kind of unity and multiplicity, and that means understanding the role and the purpose and the strength and the vitality in variation and diversity. There's an old saying the first principle of intelligent tinkering is never throw away any of the parts. It's a mechanical metaphor, but I think in a good society there will always be a diversity that's crucial to the survival of the society itself.
It's—the way you find that common ground that we did in the white paper was to take each other's views seriously, respectfully, and also acknowledge from the beginning the deep seriousness of the deliberations, how much they transcend any one generation. That's the way all future bioethics commissions should sit. They should realize that they're speaking about issues that transcend any politics or immediate purposes. That they have to be very, very serious. They have to seek that locus of consensus that is—preserves our diversity within our common humanity.
CHAIRMAN PELLEGRINO: Janet?
DR. ROWLEY: Well, I'd like to come back to the question that Alfonso raised and actually ask him in his concerns about the dilemma of how to view and treat embryos, pointing out that at least in Europe, because the number of embryos that are implanted is limited and yet the number of embryos that are formed are often in excessive of the two, I believe, that at least some countries limit implantation.
All the excess embryos are destroyed. And so that's part of the
way that they operate. In the United States, excess embryos are
frozen and either used subsequently if needed for a pregnancy or
else they are excess. And then different IVF facilities thaw those
embryos or would—it kills them or makes them available for others
if a donor approves, makes them available to other couples who have
not been so fortunate as to have their families complete.
So the question is, if you thaw the embryo or if you don't freeze it and just let it die, that's—that's the current practice. And why is it so different? And why is it so immoral to then say that parents or donors have the option of using those embryos for research that may lead to information that ultimately benefits individuals who need that information available scientifically?
CHAIRMAN PELLEGRINO: Professor
Gómez-Lobo and then Peter .
PROF. GÓMEZ-LOBO: I had
inadvertently become part of the panel, I guess. Let me take it
from a little bit from further back, if I may. It's a little bit
of a follow-up on the previous reply. I am familiar with Volume
3 of the report and—of your report, of the impact report. And, you
know, I think it's a very important document. [Available at http://bioethics.georgetown.edu/nbac/pubs/cloning1/chapter3.pdf]
On the other hand, when I go through those religious testimonies in Volume 3, with the golden exception of our chairman, Professor Pellegrino, I find that most of them are pre-1827. You know what I mean by that?
PROF. LAWLER: [Inaudible].
PROF. GÓMEZ-LOBO: No.
I was—I was not around at the time, but 1827 is, if I'm well informed,
the date in which Baird discovered the female ovum. The vast majority—I
don't remember the names. Abdulaziz Sachedina was one of the persons
testifying, and there were a number of religious authorities testifying.
And they were testifying on the basis of sacred scriptures that
all—I can guarantee that—all were pre-1827.
And I thought that in a community that should discuss these things on the basis of science and reason—it was totally unreasonable to accept those testimonies as important. And one of the things that I think is very important about our council is that we have not invited those kinds of testimonies, and the few times that I've been consulted on that I've been firmly against it—firmly against it.
No, I have nothing against religion. I hope you trust me on that one. But I do—I do want to discuss this on the basis of the scientific evidence and the philosophical conceptual convictions that we have reached.
And now I'm going to address your question, Janet . Basically, for me the key thing is that there is a good way of showing that there is identity through time between the embryonic stage and the later stages. Hopefully I won't need to develop the whole argument. You know, I've published papers on this.
But twinning is not an interruption of identity. To be an embryo
is not to be a being of a separate class. "Embryo" is
a word that designates a stage, so what matters is whether you're
a human embryo or a feline embryo. And last but not least, everybody
in this room was an embryo some years ago, some of us many years
ago, some less.
So I would be ready to develop that argument, and therefore I see—and, again, I could argue at length on this—I see it as important to hold the inviolability of every human being, every human being, and that means every human being of any age. I would be adverse to discriminate on the basis of age. We care about children. We care about the youth. We should care about all human beings of—throughout their lives.
Now, on that basis, on that basis—on the basis of the profound respect, the dignity that leads to inviolability, I would argue that to freeze human embryos in the first place is wrong. That would be my first claim. I think that having children is a great human good. I've enjoyed it, thank God, and that one should strive, of course, to have children. But it's—it seems to me inconsistent, then, to freeze a human child at a given point just for later use. So my first claim would be that we should not freeze human beings.
Now, the second point is, well, if they're going to die anyway—because that's part of the argument—why not use them? Well, again, I find that morally troubling because all of in this room are going to die anyway too. But that does not justify our dismemberment. We could use, you know, the organs of some people, perhaps some of the younger people in the audience, to provide transplant organs, organs for transplantation, but it would be wrong to do it.
So what I see is that frozen embryos create a moral quandary of which there's no way out. I don't see honestly—I think there may be adoption possibilities given the numbers of frozen embryos in the United States, I think it's unrealistic that many of them will be adopted.
But still, that does not—does not justify in my view intentional dismemberment just for the benefit of the rest of us, particularly now with the reprogramming of cells and all of the progress that has been made in that direction. So that's the way I would personally go on this issue.
DR. ROWLEY: So it seems to me that this—this raises additional problems. So it's the European way, which is not to freeze embryos and therefore to kill them immediately, is in some way more morally justified than to freeze and then thaw and kill. And you know, I'm—in this area of ethics and philosophy, I'm just an ignorant scientist, and so I have difficulty in appreciating the nuances of some of these discussions. But I have to say I don't find the distinction personally terribly convincing.
CHAIRMAN PELLEGRINO: Peter?
All right. There they go again. And I'm glad they're going over
this material, because I wasn't here when they went over it the
first time. But what have you got here? You've got two very, hugely
reasonable people having a scientific argument over the facts. Alfonso
says an embryo is a who, finally has to be treated like a who. Janet,
in the final analysis, an embryo is a what. You know, like our great
president says, it might even be above my pay grade to resolve this
in a simply scientific way. It's a great dispute.
But I notice it is a scientific discussion between two most able
people. I predict even if we extend this far beyond dinner, we will
not reach consensus on this important issue tonight because I read
the transcripts the first time. There was no consensus, and some
members of the Council, making simply scientific arguments with
nary an Archbishop being brought in, could not reach a consensus
because of reasonable people disagreeing.
Now, you've all made the good point if they— either of these two
people — were simply wise, not like Socrates on the way to wisdom,
but if we had philosopher kings on this Council, then they would
resolve this. Maybe it's true, as you've all said. Alfonso is emphasizing
some facts. Janet 's emphasizing other facts. And if we had Rush
Limbaugh on here making our—and Fox News making us all fair and
balanced, we could work this out.
But in fact, it's not going to happen. So very reasonable people are disagreeing on the most elementary facts. These are tough facts, right? So on this council, you know, through discussion you always attempt to research consensus but you fall short. And so when recommendations were made, they fell back on the political method of compromise.
Now, you might want to say it's almost horrible to compromise on this issue, but it seems to be you're stuck with it. Like we're stuck in actually making public policy with compromise on abortion, not because objectively a compromise is what's called for, but because such reasonable people are disagreeing on the most elementary facts.
So in the previous council and commission and the article, quoting Dworkin and all this, it made it—it seemed like to me the proposition was this: reasonable people, if they really thought about their opinions, would reach this conclusion that it's okay to kill embryos if you're going to save lives because you make exceptions with respect to abortion. As Alfonso pointed out, that's not self evidently true.
And so the idea that that consensus is based in reason through the quoting of professors of philosophy actually is quite tyrannical, because if you're outside of that you're like not a reasonable person. You're merely a religious person or merely an archbishop or something or merely Dr. Pellegrino, who is a fake philosopher and a real MD or something.
So it seems to me our council had the advantage of not being tyrannical, of allowing the free play of ideas on this, showing that reasonable people with high level of scientific and philosophical knowledge could not reach agreement, mirroring what's going on in the country.
And I'm not saying objectively there wouldn't be a way of working this out. It just happened that when you picked from the best and the brightest they didn't work this thing out. So it seems like finding consensus on an issue like this really does not reflect what the country actually thinks and really marginalizes quite unreasonably people who don't fall within the consensus.
CHAIRMAN PELLEGRINO: I have Dr. Meilaender and Bill, who want to comment. I just want two minutes in between just because my presence at this meeting was mentioned. My argument, the record will show, was not based on quotation of scripture. My argument was a scientific argument, and I will be glad to take anyone on on that basis. That's number one, what was recorded.
The second point is, I think these two ideas are incommensurable
and are not going to be a compromise. I think we should comment
and begin to think about how do we live together with this difference.
Now, you spoke about the process of dialectic. One aspect of the
process of dialectic is recognizing when you're at the point that
you're starting from two different propositions, and Aristotle pointed
this out in the "Posterior Analytics." At the beginning
of every argument, there is a non-provable assumption. We're at
that point in this particular discussion.
And so I would say let's comment on how we as a civilized society live together with this issue. If you'll forgive me for that clarification on my part. Now, you have the day and then Bill and then I think I'm going to have to ask for a cessation of the discussion lest we be here ad aeternitatem.
PROF. MEILAENDER: Well, I don't know how we got back to here. But I want to say—I wanted to say a word in response to Janet 's question because I don't think—it's a little different, Peter, from the way you put it. I don't think she was disagreeing with Alfonso about the status of the human embryo, though I'm sure they do disagree about that question.
I think she was for the moment granting his position and saying given that it's what you think it is, wouldn't it be better to at least get some use out of it in a process that destroys it than to simply thaw it and let it die. That's what I think.
And Alfonso gave a very complicated answer. I think the simple answer which will not necessarily persuade you, but I don think there's a difference, Janet, is the difference between letting someone die and wanting to get in on the kill. Those are two quite different things. Allowing to someone to die or aiming at their death and that I think is the distinction.
CHAIRMAN PELLEGRINO: Bill?
DR. ROWLEY: But I don't—I don't think that's so at all. I think that—I was very persuaded at the first meeting by Michael Sandel talking about competing goods. And I have no idea—and this is where I pleaded ignorance as to whether that's a philosophically generally accepted point of view or whether it's simply Michael Sandel .
But when you have competing human goods, then I think it's possible to say that in my view this competing human good takes precedence of that competing human good. And so getting in on the kill is something I find quite—I won't accept that as a— you know, as a possibility.
CHAIRMAN PELLEGRINO: Bill?
DR. HURLBUT: Well, just to underscore what I said earlier and to give our predecessors a little credit for some of this, the greatest human good in the face of an irresolvable problem is to seek another kind of solution. And let me underscore that NBAC actually acknowledged this in their work, and I've got a quote for you.
They saw this difficult debate. They knew they weren't going to solve it, and they probably knew we weren't going to solve it. And so they wrote "In our judgment the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less problematic alternatives are available for advancing the research."
Now, if the put research ahead of human inviolability, that Alfonso will see it as an error. But they did propose a solution that was respectful of a diversity views. And with those solutions at hand, let's try our best not to keep fighting about things we don't have to fight about. Otherwise, our society is going to be torn apart. I mean, serving on this council for eight years, I've felt the depth of the differences in our culture, and it's time for us to truly seek some kind of ways forward with unity in this civilization.
DR. ROWLEY: Yeah, but I want to come back because he's referring to IPS cells or induced pluripotent cells. And even people like Jamie Thompson and Yamanaka, who were at the president's signing of the executive order on Monday, they both say that IPS cells are no substitute for human embryonic cells. So to say that there are other ways and you just don't need these cells is not true right now.
Now, it may well be–and one hopes and I've got —I do sincerely hope that with continued research that IPS cells—and I have to say that that Bill Hurlbut proposed an example of this in the white paper that I was skeptical of and I was wrong that we do—I've sort of lost my train of thought. But I think that it is important that both options be available until we know that one is better than the other.
DR. HURLBUT: Or at least we should—whatever we do, we should work for the positive. That's the point. I mean, let's be clear about it. We're only going to deepen our cultural divide if we don't respectfully proceed with a diversity views. Instead of shutting down the processes that can resolve these things, we truly need to say yes we can. Work for solutions, not keep fighting battles.
CHAIRMAN PELLEGRINO: And in the mean —
DR. ROWLEY: We don't know what the end is.
CHAIRMAN PELLEGRINO: We need to work on how do we live together with something which is incommensurable at this moment. That would be my next step. I want to call—I don't mean to cut you short, but I do need to cut you short.
DR. HURLBUT: Don't forget about Robby .
CHAIRMAN PELLEGRINO: Yeah. That's what I'm about to do. Robby, I'm about to pull you up from wherever you are. De profundis are the words.
DR. GEORGE: Thank you very much, Dr. Pellegrino . I'm sorry not to be able to be there with you. I'm rather deeply under the weather.
First, I want to make a general point about ethics, just a warning that we should be careful not to oversimplify what ethical analysis is. It's very complex. Rarely is it the case that when we actually have competing human goods we can rightly resolve the question just with a consideration or a judgment of which is the most important, and you can see that very clearly just through a thought experiment, a kind of extreme case.
Imagine that there are seven people are waiting for organ transplants, vital organ transplants. One guy's waiting for a heart, a couple guys are waiting for kidneys, and so forth. And then there's one person who's in good health, but perhaps good physical but not good mental health, or someone who's mentally disabled or something like that. You could say, well, look. We could save the lives of the seven people by taking the organs at the cost of killing him of the one individual.
Now, you could say that there are competing goods here. Obviously one person's life is a good even though it's a physically or mentally disabled person for the lives of the other seven. When we say to ourselves, well, no, it would always be wrong to kill one individual even to save seven, we're not thereby saying that the lives of the seven are not important. We're not making the judgment that the life of the one is more important than the life of the seven. It's not the kind of judgment it is. So it's not simply a matter of declaring which side you're on when there are competing goods and judging one to be more important than the other.
Then I wanted to respond to Janet's point, and I appreciate Janet's sincere effort to understand why those of us who are on the other side on the embryo question from the side she finds herself on, why we come down the way we do. There was a premise to her question, though, and if I understand her correctly she was suggesting that in European practice the number of embryos created is typically the same as the number or roughly the same as the number created in the American practice.
The difference being the number—pardon me—that are implanted and with the Europeans simply destroying those immediately that are not used and the Americans are freezing them away. That was not my understanding of what happens in Europe, but perhaps my understanding is wrong. I thought that in the European situation, at least in many European jurisdictions, you do not have a large number of excess embryos produced, or at least as large a number as we typically have in reproductive practice in the United States .
So I would be grateful if Dan or someone on Dan 's staff could look into that and just let us know if the practice is, in fact, as Janet described it or as I thought it was. But either way, Janet leaves us with the question. If you're—if you have embryos that, quote, are going to be discarded anyway why not use them to advance science if you can dot hat.
And here there are really two reasons. If you consider, as those on our side do—and it's Janet 's granting here for the sake of argument, but not conceding. It's not her own view, but she's just assuming for the sake of argument that we're right about this and then asking us a question about its implications or consequences.
But assuming that we're right that human embryos are human beings who have an inherent and equal right to life, if they're going to be discarded anyway what would be the problem with using them to advance science. Two problems. One is, when someone has been a victim of injustice, then to benefit—to allow ourselves to benefit, to use the injustice committed against them to benefit ourselves, obviously raises ethical questions.
It can be very complicated. There are some circumstances in which most ethicists say that, well, if the injustice is remote enough from the benefit that you're now seeking perhaps it would be okay. But if not, then you should forego the benefit because of the injustice. So that's number one.
And then the second thing would be the concern about incentivizing people to create excess embryos or incentivizing people to not take steps that would reduce the number of embryos who are created, the assumption being here creating excess embryos when you know that they're going to be lost one way or another or destroyed justice in itself an injustice.
So Janet, just to explain at least my own position, those are the two reasons that I would cite in response to your question.
DR. ROWLEY: Well, just as Dr. Pellegrino was worried about lunch, I realize that there may well people now who are worried about dinner. But my understanding–and I think facts would certainly would be helpful here—is that part of the difference in Europe and the United States is, as I've described it before, our appalling health system, such that women and families get paid or pay an amount for the developing of the embryos, some of which sometimes is covered by insurance.
And if you have excess embryos that are frozen and if the first time implantation is not successful, you can go back to frozen embryos and use them to implant a second time at either no additional cost or a very reduced cost. Whereas the Europeans who pay for this, they can just keep going back again and again at no individual cost or minimal individual cost. And therefore, there isn't the same financial incentive as we force in the United States .
So that's—my understanding is, part of the reason for having increased numbers of embryos is driven strictly by differences in the health care systems.
DR. GEORGE: Well, Janet, then perhaps I misunderstood you because I thought the premise of your question would be that a roughly equal number of embryos would typically be created in either of the two systems and then the only question is what happens to them. Are they simply discarded as is the European model, you said, I thought, or are they frozen for possible use in the future or to be thawed and used for research in the future. Is that not right?
DR. ROWLEY: Well, this is where I said some facts would helpful because–
DR. GEORGE: Okay. Well, then it would be [inaudible]—
DR. ROWLEY: —it's my impression from reading that, in fact, fewer embryos are produced in the Europe because they're only going to implant at the most two embryos. All of this says that the embryos have to be cultured for a bit of time so that somebody using some very imprecise criteria decide which two embryos look as though they are most viable, and it's those embryos that are used in Europe .
Certainly the same criteria or similar analogous criteria are used in the United States for implantation. But there is, as far as I understand, no statutory limitation on the number that you can implant, which is why we're having an increased number of triplets, quadruplets, quintuplets and beyond.
DR. GEORGE: Yeah. Well, there are two distinct questions. One, are there limitations on the number of embryos that can be implanted, and then the second is, is there a limitation on the numbers that can be created? My understanding was there was a limitation in Europe on the number that could be created. And perhaps, Janet, if I understood now this last time, we're on the same wave length there and we think that actually fewer are created in Europe . But either way, it would be good the staff could get us the answer.
CHAIRMAN PELLEGRINO: Could I—could I have an additional minute? We had Madame Mouneyrat with us who was here this afternoon, and she's concerned about the comments re: European storage, destruction, et cetera. And I think we have a source of facts here—
DR. GEORGE: Good.
CHAIRMAN PELLEGRINO: —and we should ask her if she's be kind enough to enlighten us.
SECRETARY GENERAL MOUNEYRAT: I'm very sorry to be again in your debates. But I just would like to tell you the exact situation in France about the [French] embryo. The situation in France is defined by law, the law of 2004. So in France when you do an IVF you have to obtain approximately ten embryos. The good practice is to transfer three, no more than three. So you have approximately—it's not exact numbers, but approximately you have seven or eight embryos left.
They are frozen. And when they are frozen, the law says that the parents have three possibilities. First, they keep it for a second IVF operation to have a second child. The second possibility is to ask the destruction of the embryos after—not immediately but after—I don't remember exactly the number of months to have a reflection about the decision.
And the third possibility which has been offered by the law is
to—the word is very difficult to find because it raises an ethical
problem—is to "give" an embryo to another couple so this
couple is able to adopt it. The problem is that the French law didn't
say to "give" an embryo because you immediately see the
ethical problem because you can only give an object, and as embryo
is not rather an object it's difficult to say that you can give
your embryo to another couple.
So you have—we have a [word] in French —my vocabulary is bad—not
the word to "give" but to "receive" by the other
couple... And the law in France now limits the authorization of
research on [word garbled] embryos four years—five years. Sorry.
After five years, the law will be recommend and we have to take
a decision. And I can say that nowadays in France approximately
12 researchers have obtained the authorization to do research on
the [garbled] embryo by biomedicine agency which has been created
in France for giving these authorizations.
Thank you. It was only what I wanted to say.
CHAIRMAN PELLEGRINO: Thank you very, very much. Very relevant.
DR. HURLBUT: Can I get clarification? Are you saying you don't currently allow the research on them and you will in five years or are you saying they do now and don't?
SECRETARY GENERAL MOUNEYRAT: No.
This is precisely in debate. The state of the French law is very
complicated and ambiguous because the French law from 2004 says
that research on embryo is forbidden. It's a principle. But just
after, you find an exception to the principle, and by derogation
and only during five years certain types of research [are] regulated
by the law and with authorization by biomedicine agency are possible.
But it's a temporary solution. So as I said this morning, we are
in a period of re-examination of these laws, and the parliament
will have to pronounce to say if we continue to forbid, strictly
forbid, the research on embryo or [French] to authorize or to continue
to have this very difficult situation which forbids but immediately
after by derogation must arise which is not very clear and very
So it's a—it's the main crucial issue of the general state of bioethics which will take place in the future months in France .
DR. HURLBUT: So
it's not just the United States that has controversies and which
are also labeled from the "religious right." It's a real
human issue recognized internationally as a serious issue. And when
Janet says it seems obvious to her and Alfonso says it isn't obvious
to him, they are the two sides that are represented also in France?
SECRETARY GENERAL MOUNEYRAT: Oh
MR. CAPRON: Now, Mr. Chairman, you have the former deputy director of the human embryology—fertilization embryology authority here. You might hear what they've done in Britain .
CHAIRMAN PELLEGRINO: Well, thank you. Let me remind everybody there is a time limit here. This could go on ad infinitum. We'd be delighted to hear from you but choice words.
MR. WHITTALL: I
remember being involved with this discussion about 20 years ago.
If we start again now, this will take me way past my retirement
date. Can I just say first of all, I think it would be a mistake
to try and characterize Europe as having one policy. It is far,
far, far from the case. There are many, many different policies
across different countries in Europe, and that's why we've been
talking about it for 20 years in Europe .
It may be true that more embryos are created in a single cycle in the States than on average in Europe . It may not be true in all parts of Europe . There may be reasons for that, and I wouldn't want to go into them. They may be to do with commercial pressures, but it is not the case that in Europe all countries provide state funding for IVF treatments. That is not the case at all.
There is, in many countries, a limit on the number of embryos to
be transferred per cycle, mostly for reasons of the health of the
woman and of the fetus because of the risk of multiple pregnancy
and a wish to avoid fetal reduction, a reduction of the number of
fetuses being carried in a pregnancy, which has been a hidden problem
in a lot of countries. So I think one needs to be careful.
There is also—while there is an insistence on a reduction on the
number of embryos per cycle, that doesn't mean to say that fewer
embryos are produced unless they're frozen because there is also
again as a matter of good practice a desire to limit the number
of times a woman is stimulated through drug cycles. So actually
freezing supernumerary embryos and using frozen embryos in subsequent
cycles is actually clinically regarded to be good practice.
So this is a really rather more complicated question than I think that you've got here at the moment. And if Dan and his people want to look up the situation across Europe, that material is easy to get. I mean, we can help you out providing the reviews of the laws and practices across Europe . But I can assure you, you'll find all kinds of different customs and practices in many different countries. I don't think I need to go into the UK 's position because I don't think it would help to learn of one other one.
DR. ROWLEY: It would help.
CHAIRMAN PELLEGRINO: Janet said she might like to hear the British approach.
MR. WHITTALL: I'll
be very, very brief about that. This has been established for some
considerable time, since the law that was implemented in 1990. Embryos
are created in the course of IVF treatment. They can be used for
treatment. If any are left over, it is a question of consent of
the individuals who provided the eggs and the sperm as to whether
they will be frozen or whether they will be destroyed, whether they
will be donated to another couple or whether they will be used for
research. They have all of those options.
It is also the case that they can agree that embryos can be created purely for the purpose of research, so we're not only talking about supernumerary embryos and research in the UK . This is all framed within legislation that specifies the conditions under which they can be created, the purpose for which the research can be carried out, and that it can only be carried out under a license that surveys those conditions and that they comply with all those requirements.
CHAIRMAN PELLEGRINO: Thank you very much. I believe we've reached the end of useful discussion unless, Robby, do you want to come up with an additional point? We're about to close the meeting. Robby, I think, has gone to dinner. Thank you all very much. This has been a very good meeting.