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THURSDAY, June 12, 2003

Session 4: Biotechnology and Public Policy:
Embryo and Related Research

Michael Manganiello, President, Coalition for the Advancement of Medical Research

Richard M. Doerflinger, Deputy Dir., Secretariat for Pro-Life Activities, U.S. Catholic Bishops Conference

Maxine F. Singer, Ph.D., Chair, Committees on Science, Engineering, & Public Policy, Natl. Academies

Michael J. Werner, Esq., Vice President-Bioethics, Biotechnology Industry Organization

Andrew Kimbrell, Esq., Exec. Dir., International Center for Technology Assessment

William Kristol, Chairman, The Bioethics Project

 

CHAIRMAN KASS:  I think we should get started.

This is the second of our panels with public presenters trying to help the Council understand the current state of regulation of biotechnologies touching the beginnings of human life.

Since I had long introduction of the first panel, which I won't repeat, I'll simply say that the Council is at the moment simply trying to understand the status quo and, in particular, to understand what human goods and what values now govern whatever regulatory activities we have; also, some suggestion as to what human goods and values ought to govern here, and how well we are doing in promoting and protecting those.

The last panel was selected with the view that they would largely talk about the actual reproductive uses of these technologies.  This panel was selected expecting that most of you might be more comfortable addressing the research questions and also the commercial questions.

But you are free to say whatever you want on whichever aspect of this topic strikes you as important.

We thank you for your submissions, in advance.  You should know that the Council has prepared its own staff document, instructed by the Council to take a look at the status quo.

We didn't distribute it to you in advance because we wanted you not to react to what the staff had done, but to have your own input, and we have your original submissions that were under consideration when the draft document was done.

Our document will be available tomorrow here and also on our Web site by the latest, I think, on Monday, and we would certainly welcome your comments on what the staff has done.

Let me welcome then in order of presentation Michael Manganiello, who is the President of the Coalition for the Advancement of Medical Research;

Richard Doerflinger, who is the Deputy director of the Secretariat for pro-life Activities at the United States Catholic Bishops Conference;

Maxine Singer, who is the Chairman of the Committee on Science, Engineering, and Public Policy at the National Academies of Sciences;

Michael Werner, who is the Vice President for Bioethics at the Biotechnology Industry Organization;

Andrew Kimbrell, who is the Executive Director of the International Center for Technology Assessment;

And William Kristol, who is the Chairman of the Bioethics Project.

We are going to ask you to try to hold as best you can to five minutes.  We will take you seriatim, hold our questions and discussion to the end.

We thank you for your presence.  We look forward to your comments.

Please.  I think you have to press -  maybe it would be best if you could get it a little closer to you.

MR. MANGANIELLO:  How's that?

CHAIRMAN KASS:  Is that all right?  Can you hear from the back?

Please.  Thank you.

MR. MANGANIELLO:  Good afternoon, Chairman Kass and members of the Bioethics Council.

The Coalition for the Advancement of Medical Research, CAMR, values the opportunity to offer remarks on the regulation of technologies and practices relating to embryonic stem cell research.  Although CAMR is honored to testify today, the coalition feels the voices and strong beliefs of the patients in this country suffering from disease and disability should have been considered in the formulation of this commission and in the conclusions you came to last year.

The coalition is comprised of more than 75 patient organizations, universities, scientific societies and foundations advocating for the advancement of breakthrough research and technologies in regenerative medicine in order to cure disease and alleviate suffering.

It is disappointing that the voices of so many organizations dedicated to medical and scientific research were not considered in establishing a policy that affects over 100 million Americans suffering from presently incurable diseases and disabilities.

CAMR strongly supports the freedom to conduct ethical research and explore biomedical science in the hope of finding potential treatments and cures for society.

Furthermore, we strongly support federal regulation of research to insure that it is safely and responsibly executed.  By stalling the advancement of regenerative medicine, we are sending a message to researchers and young academics, in particular, that scientific inquiry is suspect.

For example, it should be noted that over two- thirds of the U.S. population supports somatic cell nuclear transfer research to produce stem cells.

However, your commission's recommendations for a moratorium will delay and deny hope to millions of Americans.

The field of biomedical research, biomedical science adheres to regulations set by state and federal regulatory systems.  As you know, Congress has failed to regulate cloning, but scientific discovery continues in this field without a ban on reproductive cloning and no regulations on SCNT for research.

CAMR concurs with the report issued by the National Academies of Science in June of 2002.  The National Academy of Science, the nation's most august scientific group, concluded that while the science of reproductive cloning must not be pursued, SCNT is likely to be the best technology to cure deadly and crippling diseases.

SCNT can also be used to understand the genesis of disease and provide an opportunity to advance the understanding and biological and cellular mechanisms.

All Americans will suffer from the restrictive environment in our scientific community which has indefinitely delayed the development of stem cell therapies.  The President's policy limits federal funded research to a homogeneous group of human embryonic stem cell lines.  Since some diseases are gender, race, and ethnicity specific, it is vital to have a genetically diverse group of lines to study.

A greater number of stem cell lines available for a study would provide statistically significant results.  Our scientists are being driven into a sequential form of research rather than research done on parallel tracks.

In addition, as was stressed recently by Dr. Ron McKay and Dr. John Kessler in recent Senate testimony, "The history of the cells or the way they are derived may change their behavior."

The President's policy means, as Dr. Kessler said, "We will perhaps be developing cells the one way that is not the optimal way, so we need to expand our ways of trying to develop the cells."

Additionally, the President's policy not only severely restricts the work of stem cell researchers, but encourages the exportation of a very promising field in the biotech industry.  Scientists in many countries of Europe and Asia do not face the constraints in place in the United States.  These nations are making embryonic stem cell research the cornerstone of their biotechnology industry.

America is losing its preeminence in medical research.  Rather than sitting on the sidelines, we should be supporting America's ingenuity and experience by promoting and regulating the expertise of our scientists.

CAMR has strong reservations about the President's decision that was announced August 9th, 2001, regarding funding human embryonic stem cell lines.  This broad public policy was grounded in political expediency.

Dr. Zerhouni, the Director of NIH, has publicly admitted that there are only 11 stem cell lines available at this time, not 64, and they are simply not enough.

The American Society of Reproductive Medicine recently established that there are over 14,000 embryos in the U.S. that would be donated for stem cell research by the couples that created them.  If that research is not permitted, those 14,000 frozen embryos are set to be discarded as waste.

It makes no sense to forfeit the knowledge that our scientists would gain from the stem cell lines that could be derived from these embryos.

The field of stem cell biology should move ahead on all fronts.  It would be devastating to proceed in only limited fields of research and discover the science is flawed.

Our scientists should receive federal funding to conduct research using stem cells from any source:  adult, embryonic, and those created by SCNT.

Working independently, with limited funding, scientists in the private sector and the laboratories of our universities have already achieved breakthroughs that clearly demonstrate the promise of stem cells, but without a reversal of the administration's policy, their efforts may go unrealized.

Congress and the administration should support SCNT, ban reproductive cloning, and allow broader federal funding of stem cell research to provide hope for better treatments - I repeat hope for better treatments - and cures for our fellow citizens; maintain America's dominance in the biotech industry; and pro-actively regulate new medical treatments.

The 75-plus members of the coalition, the National Academies of Science, the 40 Nobel laureates who sent a letter to President Bush, Senator Orrin Hatch, former First Lady Nancy Reagan, the State of California, England, Israel, Sweden, Singapore, and China, among countless groups, states and countries have given serious thought and attention to this matter, and they have spoken.

Promising medical research must proceed.  These are our neighbors, our friends, our allies, just as moral and as ethical as anyone sitting in this room.  Who are we to ignore them?

Thank you.

CHAIRMAN KASS:  Mr. Doerflinger.

MR. DOERFLINGER:  Thank you, Mr. Chairman, and the Bishops' Conference is grateful for this opportunity.

I have a longer statement and appendix that I've distributed to the council.

I was asked to comment on the principles and values that are at stake on these issues, and that is the aspect of the issue that we feel most comfortable talking about.

There has been a substantial, though certainly not a unanimous, consensus on certain key values and principles that are relevant here.  Tragically, even when those key values and principles have sometimes been stated by advisory boards to the government dealing with this issue, they have then been neglected when the time came to use them as a basis for public policy.

The first norm I'd like to talk about is simply the importance of ethics itself— that medical research can and should always be guided by fundamental ethical norms.  I say "guided by" rather than "balanced against,"because one of the ways in which the principles of declarations like the Nuremberg code, the Declaration of Helsinki and other instruments have been somewhat eroded in recent years is with the claim, sometimes written into proposed legislation, that ethical and scientific considerations must be balanced against each other in promoting research.

But if they have to be balanced, that means that even when you know something is unethical, you can go ahead and do it anyway as long as the medical benefit is, or is thought to be, great enough.

And that is what the Nuremberg code and so many other instruments in our history stand against.  CAMR, for example, says it supports ethical research, but that is exactly what we're here for.  They say we have to give greater weight to the demands of patients — I am one of those who thinks that the demands being made by the patient groups are not at all, on embryo research, coordinate with the actual needs of patients.

But to say that that has to be weighed in the equation is to turn this into a cost-benefit calculus.  If ethics matters, then it has to matter when it keeps you from doing something that you very much wanted to do.  If the only things ethics keeps you from doing are things that were useless anyway, it doesn't have much weight.  It doesn't have any weight.

And that's what has happened in some of the government advisory panels that dealt with this issue.  The Human Embryo Research Panel actually endorsed the ethical theory of its ethics co-chair, Ronald Green, who set up what he called a Copernican revolution in our thinking about the ethics of research.

Essentially the Copernican revolution is to turn the Nuremberg code on its head, and instead of saying that ethical norms form an ultimate barrier to potentially useful research that ignores the interest of the human subject, that medical benefit simply can cause one to redefine that subject as not being due any respect.

That brings me to the second norm, which is respect for developing human life, even at the embryonic stage.  It is commonly thought that this argument is about when life begins.  The astonishing thing is that all the government advisory panels that have dealt with this issue —the Ethics Advisory Board in 1979; the Human Embryo Research Panel in 1994; NBAC, the predecessor to this commission in 1999; and the National Academy of Sciences — all describe the early embryo as a developing human, in the case of the NAS, or as a developing human life that deserves respect.

Respect is a very important term.  It means a kind of inviolability.  It means someone who should be respected as an end in him- or herself not only as a means to something else. And that means that when we have avenues of research presenting themselves, each of possible benefit — at the very least NBAC did recognize this —  it means that we should pursue and exhaust the avenues that do not contravene that respect before we consider doing something that would violate that respect, even as a last resort.

That burden has not been met in the case of embryo research.  For instance one could make a very good case that it is far less promising for the full range of diseases represented in CAMR than many avenues that present no moral problem.

The third norm that I think is important here, and it relates to the reproductive technologies, is the dignity of procreation of marriage and family.  There are aspects to some of the reproductive technologies, cloning being the most obvious, in which we very much endanger dehumanizing or denaturing our very notion of the relationship between parents and children.

That's most obvious in cloning when the entire procedure is reduced to a manufacturing process to preset specifications.  But some of those problems arise in the other reproductive technologies as well.

Setting aside the fact that parents who resort to IVF can be very loving parents, the procedure by its nature is the kind of procedure that tends to invite abuses like seeing this embryo as an object for experimentation, particularly among those who actually practice it in the laboratory.

Finally, in terms of specific recommendations, we propose a series of those at the end of our prepared text.  We support, of course, a complete ban on cloning for research or reproduction.  We support a ban on federal funding of human embryo research, and we would invite the council to look at laws in Louisiana and South Dakota that try to embody the principle of respect for embryonic life in the research context.

We also are very interested in what this council may have to say about the regulation of reproductive technologies, such as IVF.  But we would also caution against any regulatory approach that assumes that one has to fund or actively support that industry in its basic form in order to prevent abuses, particularly since in our analysis it is the very nature of the IVF procedure that has led to and invited those abuses.

I have much more to say, including contradictions of much of what Mr. Manganiello said, but maybe we will get into those in the discussion.

Thank you.

CHAIRMAN KASS:  Thank you.

Dr. Singer.

DR. SINGER:  Chairman Kass, thank you for the opportunity to come.

I'm going to try and answer the questions that were posed from the point of view of at least one member of the scientific community, and I'd like to say that although I am the Chair of COSEPP, my remarks today do not represent the views of COSEPP or the academy's.

So the education of scientists actually builds on two historically validated values:  first, to increase knowledge and understanding, in particular, about the natural world; and, second, to apply that knowledge for the benefit of human beings.

Physician scientists have additional values, including the commitment to do no harm, and it is these values together with intense curiosity that drive most scientists to ask and try to answer technically and intellectually challenging questions.

In all fields of science the application of knowledge means, first of all, sharing it with non-scientists, but application of new knowledge also has more material effects, and people have for millennia used scientific insights from various fields for new materials, for new tools, for new agriculture.

Starting perhaps from Jenner and his cowpox vaccinations in the early 19th Century, biology began to impact people's lives more directly through medicine. 

At the same time, some research itself and most of the material benefits of research can be associated with new kinds of problems.  Some research is dangerous for the researchers and the general public, and examples would include work with pathogenic organisms.  Scientists welcome and even initiate regulation and restriction of such research.

In a pluralistic nation like ours, scientists are also respectful of restrictions based not on possible hazards, but on other kinds of societal concerns that are sufficiently widely held to justify cautionary practices.

Current examples would include the rules and laws governing clinical research with patients and human subjects, the humane treatment of animals, and even the planting of genetically engineered crops.

But it is essential to keep in mind that regulation, restrictions, and controls are not the same as an outright ban on research.  Contemplation of such bans is only appropriate under particularly compelling situations.

Well, what I've just described is the context in which many, if not most, biological scientists see the Council's current agenda.  Thus, as far as we know, most scientists, but in fact not all, agree with this Council's conclusion that human reproductive cloning should now be outlawed, and as you all know, several reports from the National Academies agreed with that.

This conclusion is based on compelling scientific evidence from research on other mammals that reproductive cloning is both dangerous and likely to fail.

The situation for other avenues of research with human embryos is quite different.  First of all, no hazards to researchers or the general public have been identified.

Second, as evidenced by testimony to NBAC, to Congress, and to this Council, there is no common view among the public about how to balance concerns expressed by some segments of the general public against the possible knowledge and applications that can follow from the research.

And in this I clearly agree with Mr. Doerflinger about the need to balance concerns.

So the conclusion is that a moratorium on such research is not justified.

But restrictions and cautionary practices are another matter, and thus, according to the policy enunciated by President George Bush on August 9, 2001, federally supported U.S. scientists can use for research certain lines of embryonic stem cells that were established prior to that date from spare embryos made for reproductive purposes, provided that there is informed consent by the donors and no financial inducement.

The NIH has taken a variety of steps to assure the availability of such cells and their use under appropriate conditions, and this has allowed important research to proceed.

Nevertheless, these few cell lines - at last count 11 were available - cannot for a variety of reasons permit the full program of important research that scientists envision.

Additional cell lines from diverse populations and developed under different protocols will be essential.  Moreover, to realize the full potential of the research, it will be important to work with embryonic stem cell lines derived from the transplantation of a somatic cell nucleus into an enucleated egg.

Here, too, there is evidence that societal concerns about the research do not reflect a broad consensus.  The Congress is stalemated over the issue of allowing this research with the unfortunate consequence of providing no moratorium on reproductive cloning.

It would be appropriate now to outlaw the implantation of a blastocyst made by somatic cell nuclear transplantation, into a uterus because that's a bright line.  While research with such cells can be done by a single scientist in a laboratory, implantation requires several people, and this is unlikely to be done surreptitiously if the penalties are severe because the more people involved, the more unlikely it is that they would conspire successfully to break the law.

So rather than a slippery slope, it seems to me this is more like the edge of a steep cliff.

The views in our country about the nature of a fertilized egg cell and a blastocyst are so opposing as to appear to be unreconcilable at the present time.  And we have dealt with the situation in the messy ways that a democracy does deal with such a situation.

So we find that reproductive cloning remains legal.  Research on developing eggs, blastocyst, and embryos also remains legal even if they're made by SCNT so long as it is not carried out with federal funds, in which case it is perfectly legal and possible.

Most of the nation's scientists depend on federal funding, and thus are similarly barred from developing new cell lines by nuclear transfer, and barred from carrying out research with fertilized eggs in a dish or blastocyst.

At the same time, research with such materials can, as I said, proceed with private resources and is not subject to any governmental oversight or regulation.

Various states have passed, and others are considering legislation, and those laws are really all over the map.  Some of them encourage the research.  Some of them prohibit it, and so we have a patchwork.

That patchwork may have advantages for a few people, but it can encourage undesirable procedures and exploitation for personal gain at the same time that it prohibits our best scientists from undertaking this important research.

Thank you.

CHAIRMAN KASS:  Thank you.

Mr. Werner, please.

MR. WERNER:  Good afternoon, Mr. Chairman, members of this distinguished Council.  My name is Michael Werner.  I'm Vice President for Bioethics for the Biotechnology Industry Organization, BIO.

Thank you for the opportunity to speak today about the values underlying appropriate regulation of biotechnology and biomedical research.

BIO members conduct genetic, cellular, and protein research and develop health care, agricultural, industrial, and environmental biotechnology products that are used by billions of people worldwide to identify an unmet medical need, improve the quality of the food supply, and broaden scientific understanding.

The biotechnology industry is a remarkable success story.  There are currently 157 FDA-approved products on the market that have helped more than 325 million people worldwide.  These people suffer from illnesses such as Hepatitis B and C, arthritis, cystic fibrosis, multiple sclerosis, many forms of cancer, and on and on.

Our industry has achieved these accomplishments in part because the state and federal regulatory system that governs the development and use of our products works very well.  Our nation's regulatory system assures patients and their physicians that they can rely on the safety and efficacy of our products.

Biotechnology companies have always worked with and within this regulatory system to ethically bring safe and effective products to market, and we're proud that our scientists have been able to sustain aggressive lines of inquiry while complying with a robust and diverse regulatory system, including oversight from agencies such as the U.S. Food and Drug Administration, the National Institutes of Health, and others.

We believe that knowledge and understanding progresses not only through scientific research, but also through dialogue and discussion.  Throughout its history BIO has been actively involved in bioethics education and discussion inside the industry at all levels and branches of government and with the public.

Many years ago, BIO formed a bioethics committee chaired by a member of our board of directors to discuss bioethics issues, and our board has adopted a statement of ethical principles that details ethical uses of biotechnology, and we're proud that the previous chair of our committee served on the National Bioethics Advisory Commission, the group that preceded you.

The existing regulatory and ethical framework within which biotechnology companies operate has successfully protected patients while allowing critical research to advance.  Appropriately, current regulations embody values, such as autonomy, such as whether to participate in a clinical trial, beneficence, and social justice.

These values should remain the basis of any regulatory system, and in addition, personal autonomy and privacy as well as academic freedom should be a crucial part of the discourse for further understanding the use of what you refer to as new technologies and practices in assisted reproduction, embryo research and human genetics.

The American legal system is grounded in the fundamental right of individuals to define their own existence through personal and shared decision - making.  BIO members share the belief inherent in American civil rights laws that our lives are not preordained by our genetics, but are often the result of choices that individuals make, choices that parents make for their children, and the opportunities available in our communities and our physical environment.

Choices such as whom to marry, whether to have children, how to raise those children, whether to accept or refuse medical care have all been protected by the Constitution, and the individual has the right to make these decisions whether or not biotechnology products or an understanding of genetics is involved.

Individuals' freedom of self-determination extends to parental rights.  American law and societal norms have historically respected the family's rights to autonomy and have long recognized patients' rights and responsibilities to make decisions that affect their children's future.

These rights and duties should be read to include responsible use of genetic information, as well as other medical, social, and personal information about a child. 

BIO strongly supports education about biotechnology and genetics and the freedom to explore their potential uses for the benefit of humankind.  State and federal regulatory systems must support and promote freedom of responsible inquiry which is at the heart of First Amendment protected academic freedom.

These values animate our members' research and their development of products that licensed practitioners use to provide services that may be elected for themselves and their children.  Such products and services allow millions of people to pursue their own destinies as they choose to live productive and healthy lives.

So, in conclusion, appropriate regulation of biotechnology is solidly rooted in values such as autonomy, privacy, beneficence, social justice, and intellectual freedom.  BIO supports responsible and ethical testing of new technologies and believes that decisions regarding whether and how to use medical products and technologies always must be made with profound respect for the rights of patients.

We cannot condone regulations that unjustifiably curtail intellectual freedom of researchers to think and dream in the pursuit of greater understanding which could lead to a better life for all of us.  Patients and their families are counting on our companies to develop products to meet unmet medical and health care needs.

Thank you very much.

CHAIRMAN KASS:  Thank you.

Mr. Kimbrell.

MR. KIMBRELL:  Thank you, Mr. Chairman.  I thank the Council for inviting me here.  This is a fascinating and important subject that so many of us around this table have grown gray dealing with over all of these many years.

We have submitted a paper on pre-implantation genetic diagnosis, and I will be here during the public comment period tomorrow and maybe we can talk about some of the issues there that we thought were important for the Council to think about, Mr. Chairman.

CHAIRMAN KASS:  Thank you.

MR. KIMBRELL:  In the brief time that I've been given, I want to try and make three points, which is probably hubris in itself.

The first one really comes from that long history that so many of us have on this issue and I've had as an attorney on this issue for almost 20 years.  We often approach these issues, it seems to me, with kind of a technological amnesia as if we were looking at these issues for the very first time, and of course we're not.

I remember at least two instances of where we were looking at a miracle cure du jour, which unfortunately means that we had to trample some of our most important ethical norms, and this is really the third one that I've been looking at.  I'd like to bring you back through that history.

By the way I'd probably just like to start by saying that Dr. Michael West of ACT went before the Senate almost two years ago and said within six months that he would not only have isolated stem cells from cloned human embryos, but that they would have been differentiated sufficiently so that he could cure several major diseases.

He told Senator Harkin, who was chairing that committee hearing, that even a six-month moratorium would cost millions of lives, at which Senator Harkin said, "Thank God we have some real numbers to look at in this debate."

So the subject of this little session is hyperbole versus healing.  I remember very well doing a lot of litigation in the fetal tissue controversy of the middle '80s.  I remember The New York Timeseditorial that warned, "To interfere with these fetal tissue experiments is to interfere with the progress that could save countless lives."

You may have already heard some of that from this panel.  I'm sure you've heard it from a number of other panels.

We brought up several important issues that needed to be looked at.  Should these fetal organs, should the fetuses themselves be for sale?  Should there be some limit on their use?  Could you use them for cosmetics, or in one case in England, for earrings, freeze-dried embryos, or should you only use them for serious diseases?  Should you use them for all?

What about changing the method and manner of abortion in order to get fetal tissue that was more valuable or could be more valuable?

What about informed consent?  What does informed consent mean when something isn't dying of itself?  It's a chosen death.  What does the concept of informed consent mean?

The Reagan administration, based on many of these concerns, correctly, I believe, declared a moratorium.  One of the first acts of the Clinton administration was to lift this moratorium, without asking a single one of these questions, under the rubric we need to save countless lives.

Well, let's look back now 15 years, 200 million federal dollars spent on fetal tissue research.  I don't know how much private.  I don't have those figures, but well over 200 million.  How many lives have been saved?  Zero.

And with 15 percent of these patients that I don't think ever should have gotten this fetal tissue, what happened?  Well, let's quote the guy, Dr. Paul Green, who is at Columbia University College of Physicians and Surgeons who actually was the lead researcher in the federally funded study, and he described his patients - because what happens, when they put the fetal tissue in their brains, they cannot control the amount of chemicals they put out.  And so he described these patients writhing, twisting, jerking their heads, flinging their arms about, spasms so severe they could no longer eat, needing feeding tubes.  This is 15 percent of the patients.

For others, spasms made their speech completely unintelligible.  Despite these effects, Dr. Green says there's no way to remove the transplanted fetal cells to stop them from creating these impacts on the patients.  "It's tragic, catastrophic," Dr. Green explained.  "It's a real nightmare, and we can't selectively turn it off."

As for the near future, Green said, "No more fetal transplants.  We are absolutely and adamantly convinced there should be research only."

Countless lives?  We don't have regulations right now.  We have basically open sale of fetal tissue.  We gave the HHS some very vague guidelines which they've never enforced by their own admission.

All of those important ethical questions trampled over, no regulations because, oh, goodness, we don't want to get in the way of something that might save countless lives.

So who are the victims?  The very patient groups that have been talked about.  They are the ones who are the victims of this, and of course, again, our ethical norms.

Let's look at another one, gene therapy.  I filed the first lawsuit against the Recombinant DNA Advisory Committee.  Dr. Singer may remember some of this history.  We successfully sued them because they didn't have an open process for deciding who would get gene therapy and who wouldn't.  All right?

We talked about the incredibly important questions about once we start changing genetic make-up of human beings, shouldn't we wait?  Shouldn't we look at this?

No, we need to save countless lives.  French Anderson and others were called genetic wizards, miracle cures.  Fifteen years later, hundreds of millions of dollars later, how many people have been cured in the United States with gene therapy?  Zero.

First we heard about one death.  Then we heard of another death of a patient.  Now they're looking at over 1,000 serious adverse events, and from one of the purported cures in France, we get a report that this retroviral vector they used, which many of us knew and I wrote about in my book in the early 1990s, has caused a rare and unknown form of leukemia in two of the young patients.

So now we have another miracle cure du jour, which is a very naive sort of American view of how to cure disease anyway.  Disease is obviously very complex.  It has environmental, genetic ideas, and once again we're asked to trample over these.

So we have been here before, and I think to approach this issue in a kind of, again, technological amnesia, does not reflect both the suffering of those who have been misused in this process for venture capital and other reasons and the failure of Congress, and the failure of our regulatory agencies to take these ethical issues seriously and to be railroaded by these false hyperbolic claims.

And I hope this Council and I hope, as well, members of Congress will no longer be subject to that kind of blackmail, particularly with this history.

The second point I'd like to make is that we shouldn't substitute regulation for ethics.  All right?  Richard Weaver said we should never substitute arguments of consequence for arguments of definition.  If we believe something definitionally shouldn't happen, it shouldn't happen.

In both of those cases we gave HHS guidelines saying, "Hey, you look at the ethics of fetal tissue and you go out there and make sure that whatever ethics you decide on, HHS" - well, we haven't done anything. 

We had the Recombinant DNA Advisory Committee looking at all of these gene therapy experiments.  Of those 1,000 serious adverse instances I talked about, researchers only reported 37 of the 1,000.  It took independent investigators to come in to find the rest of them.

So let's not substitute regulation for ethics and make sure if we have something to say ethically we say it.  It's said by our policy makers and not give it over to the agencies because it just doesn't happen there, and as an administrative law attorney, I can tell you if you're looking at enforcement these days, it's a very, very difficult issue.

The third thing I would like to say very, very quickly is I would like  to recommend that this Council take a look at a very important legal precedence that is developing that might create a kind of a consensus that Dr. Singer was talking about, that Doerflinger was talking about, and that's the Tennessee Supreme Court case, Davis v. Davis.  They came up with this idea of a special entity, the idea that an embryo is neither property nor a full adult person, but is perhaps a special entity because of its in potentia, human life in potentia.  It has a trajectory that could make it a full human being.

As such it is due respect.  As such it is due protection.  In this way we cannot remain deadlocked in this ideological divide between it has the legal status of a person, it's murder, or it's no more important than a toenail, or it can be used as a medical device and be patented.

And I'm hoping that perhaps by looking at a consensus around either a special entity and that combining with other ethics - I'm not suggesting that it be a fundamental that we can all agree with, but as a policy given our current legal precedent, as a policy context that that special - that we look at the embryo as legally a special object that needs certain respect, and in that sense I hope we would do at least three things.

Say if it is a human life in potential, no sale, no patenting, and it should never be created solely for its own economic exploitation or destruction.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Bill Kristol.

MR. KRISTOL:  Thank you, Dr. Kass. 

Maybe I should say a word about how I came to be particularly interested in these sets of issues.  I had studied and taught political science and political philosophy for a few years and then served in government for a few years and then have edited a magazine for a few years.

And in all of these, as someone who, therefore, believes in a vigorous debate in a whole bunch of areas of public life, I was struck in 1999 and 2000 how little serious public debate there was beyond specialists and beyond experts in this whole range, about this whole range of questions in the field of bioethics, the so-called "Brave New World" issues of where we were going with the biogenetic revolution.

I remember writing an editorial on the eve of election day 2000 saying that I was really shocked.  I think historians reflect that these  pretty fundamental issues about shaping our nation's future and even the future of the human race had not even been considered during the election campaign or at all or barely in our public life.  Dolly was cloned and there was a flurry of interest, and it quickly subsided.

There were occasional similar flurries of interest.  They quickly subsided.  I actually was heartened in 2001 when we started the Bioethics Project to try to foster this debate and with a certain point of view of skepticism about or at least a point of view that there needed to be some countervailing force to the huge dominance of the avatars of progress, untrammeled scientific and genetic progress in this area.

We started the Bioethics Project.  We were heartened actually by the debate in early 2001 about embryonic stem cell funding.  It was a serious debate actually and raised important issues. 

The President made his decision on August 9 and then September 11 happened.  It's hard to know whether the short-circuiting of the debate might not have occurred, I suppose, if everyone hadn't moved on to an awfully important threat and how to deal with it after September 11, but I think it is fair to say that since then I don't think we've had a particularly enlightened or enlightening - really with the exception of the efforts of this Council - public political debate about these issues.

I find that depressing.  I find it something of a scandal really since these are awfully important decisions that are being made about our future with no debate comparable to the debate I think that  takes place in all kinds of other areas:  foreign policy, economic policy, you name it really, but in this one area there's not much debate.

People are intimidated, of course, because of the scientific expertise that's required or that's claimed to be required.  Those who were dominant in this field that were driving policy, as is always the case with dominant interest groups, have no particular reason to welcome debate.  If you're in the driver's seat, there's no reason to encourage a big public debate, and I think that has been actually the behavior of the scientists, of the business types who have been getting their way with rather little regulation, as has been pointed out, in a fairly untrammeled way.

There's a tendency to sort of caricature the opponents and beat back the efforts of modest legislation and regulation and then move on.  The values, so to speak, that are embodied by scientific progress, by health, by business, if you put those three together -  science, health and business, and they basically do come together in this area -  against any serious curbs, ban, or even regulation, those are awfully hard to fight, especially when there's no, as I remember from my days in political science, when there's no equally organized interest group with real interests on the other side.

There are certain people with strong views on the other side, some of whom are somewhat well organized, but that's not really enough, ultimately, to stand up to the assault by the entire scientific establishment, much of the medical establishment, those who claim to speak on behalf of patients and on behalf of health, and those who claim to speak on behalf of scientific progress and large chunks of the business community, which is powerful in a commercial republic like ours.

And so I think the state of debate, if I can address just that little part of what you asked us to address, what do we think of the state of debate on these issues is, with the exception of the work of this Council, something of a scandal; and an awful lot of disingenuousness is gotten away with.  There's an awful lot of talk about respecting nascent human life; and respecting the embryo, though it doesn't deserve full protection, it deserves respect.

It never turns out that any embryo should actually ever be protected from any procedure as a result of this vague respect, but this is simply a way of throwing a bone to those who are discomfited, and then moving right along with whatever.  People who run IVF clinics or scientists who want to do embryonic research, who want to do -  we slide down a path from assisted reproduction, to selective reproduction, to enhanced reproduction, and again, at each stage these steps are incremental.  They're small, and sometimes the scientific and medical establishment will acknowledge that at some point there probably should be a ban on something, but it should always be the something that is over the horizon, and indeed we've seen this, of course, very clearly with stem cells and cloning where many advocates of government funding for embryonic stem cell research strongly made the point that, "Well, there are these spare embryos; it's ridiculous not to use them to advance human health."

But, of course, that's a very different thing from creating embryos de novo and then destroying them and then, as soon as that became scientifically desirable, of course, the limitation that had been expressed quite powerfully, actually just months or very few years before, was forgotten and anyone who stood in the way of so-called research on cloning or experimental cloning was then standing in the way of scientific progress.

So I have no recommendation, except this:  that I think the debate is important, and I think the debate, to be serious, must be not just public but political, and I think the political debate, to be serious, must at some point call on participants in it to be honest about what they would permit and what they would not permit.

And it is not in my view sufficient to sort of pocket everything that has happened up till now, put all of that out of bounds, one is not allowed to question anything about the status quo.  And I would just ask this of all the very powerful, well-financed groups that represent patients' groups, physicians, scientists:  Is there anything about the status quo that discomfits them?  Is there anything they would like to change or bend?  Is the status quo of IVF clinics - 400,000 spare embryos, no ban on creating embryos for the sake of destroying them - is that just fine?  Is there anything that should be limited that currently is permitted?

So, first of all, I think to be serious one has to talk about limitations and restrictions at some point, and I'm curious whether people think there's anything that now exists that shouldn't exist and anything that is now permitted that shouldn't be permitted.

And, secondly, as I say, looking forward, I think it shouldn't be acceptable to sort of claim to be for debate, for thoughtfulness, for respect for everyone's opinion, but then it just turns out that in every single possible concrete choice that has to be made, well, in this particular case, the ostensible claims of health and science and progress trump whatever ban or limitation or moratorium those who are more skeptical are suggesting.

CHAIRMAN KASS:  Thank you all, and let me start to see if I can pull together some threads and actually where Bill Kristol left off is one of the two kind of general questions I would like to put to the panel.

I would hope that this not turn into a specific argument on the status of the embryo.  We could be here all day.  We know that our group is divided on that.  The panel before us is divided.

I would like to try to generalize from that to certain larger questions.

It seems to me that we have heard from three of our panelists a strong defense of the values of the growth of knowledge and understanding, translating that for the benefit of humankind, especially the benefits of health and the cure of disease, and the sort of betterment of human prospects through science based technological application.

Those speakers acknowledge the importance of doing this ethically.  In some cases the ethical norms that were operative were given some specification as in, for example, avoid doing harm, the question of danger and safety, one that's congenial to everybody and we need not argue about it.

But beyond that question, respect for the human subject of research so that we adhere to certain kinds of guidelines and research.  Maxine Singer mentioned even some concern for animal welfare, although the respect question there is again one of these difficult questions that gets debated.

And in Michael Werner's presentation, a listing of autonomy, beneficence, social justice, intellectual freedom, that was sort of one family of concerns.

Richard Doerflinger suggests, first of all, the importance of ethics not as something to be balanced, but as something to guide or to regulate, and then goes on to emphasize respect -  questions of respect and questions of dignity which are not exactly the same as the questions of rights, privacy and autonomy, and that's at least one of the areas where we've got some kind of disagreement, and then some kind of concern really for truthfulness and not taking advantage, in fact, of the people in whose name we speak. And the importance also, as Bill Kristol suggests, that up at least until this point we have had a more or less laissez-faire attitude with respect to these innovations, but given that the stakes appear, at least to some people, to be much higher, and that these technologies serve not merely human health, but goals beyond health, and that the means to attain that technology is also threatening to trample values that some people hold dear, the importance at least of lifting up to public debate and actual public scrutiny and political argument the questions of where we are going, how fast, and under what kind of guidelines.

I think that summarizes reasonably well, if I say so myself, the things that I heard to bring it down.

Now, it seems to me that two kinds of challenges might be raised to the different parts of the panel.  I would be interested to know from, let's call it the science/research/technology/patient side of the panel, what kinds of goods or values you yourself might see justifying limitations on the freedom to conduct research, even beneficial research in this area or that might get in the way of business as usual in commerce?

In other words, assuming that the government left you alone, but you were simply trying to think through how you might deal with the concerns of the other people in this discussion, who, by the way, I would think we would say are defending things that if you don't hold dear, you ought to hold dear.

The question is:  What are the kinds of moral boundaries apart from questions of safety or letting the patients have what they want?

And I could give you some lurid cases to try things out, but I'll leave the question general at first.

Whereas it seems to me Richard Doerflinger or Bill Kristol or Andrew Kimbrell, the question might be put in a different way.  We now have a very awkward situation where this whole area of reprogenetics has not really been subjected to federal scrutiny or regulation except indirectly through safety and efficacy criteria of the FDA or IRBs that govern research proposals involving human subjects.

We don't have it, in part, because at least some of the values that are of importance to people suggest that to suggest that this practice be regulated is to countenance it in the first place, and that we refuse to do.

So it does seem to me that for the first group of people who are regulation-shy, the question is:  in the absence of regulation - I guess let me make it two questions.

What kinds of moral boundaries would you impose upon yourself or your scientific colleagues or your industrial colleagues, and are you prepared to enter into a discussion with people outside your community to seriously discuss what those boundaries might be and actually live by them as a result of the political process?

Because if I might correct Mr. Werner, this isn't just wishing and dreaming, thinking and dreaming or inquiring.  There are deeds here.  There are deeds involving human materials and human subjects, which means that you're in the realm of action and not just thought.

And for the other side, what's the cost of doing nothing in this area and leaving this area completely unregulated, the sole benefit of which is you do not expend public funds and do not give public sanction to an area of research that you regard as deeply morally questionable?

It seems to me both sides here - I would like to lean on both sides in this discussion as the Council tries to think about our regulatory difficulty and see what you might have to offer.

If you wouldn't mind, if I could address the first question to the scientists, the BIO people, and then the other question to the other three of you.

Maxine Singer, please.

DR. SINGER:  I'd like to make two points, Leon.

First of all, I don't think it's appropriate to describe the current situation as being without any limits.  It is impossible to carry out research with embryos or with fertilized eggs in dishes or with blastocysts with federal funding, and that means that most of the research that could be done cannot be done because most scientists in the United States are dependent on federal funds.  So that's a reality.

CHAIRMAN KASS:  But that research can go on in the private sector.

DR. SINGER:  Exactly.

CHAIRMAN KASS:  And it does.

DR. SINGER:  It can go on in the private sector, and it goes on now without any restrictions or controls as I think I've pointed out, and I believe, and I think that there's good evidence for this, that most people who thought about this in the scientific community understand that there ought to be controls on this kind of work.

But at the present time we have no controls, and most of the scientists in the country can't do their research, and therefore, they're not interested in discussing how they might do it or regulations or controls because they can't do it anyway.  So that's -

CHAIRMAN KASS:  But let me put it the other way, Maxine.  I mean, it seems to me the argument seems to be, give us the money and then we'll figure out what regulations -

DR. SINGER:  No.

CHAIRMAN KASS:  Whereas -

DR. SINGER:  Not at all.

CHAIRMAN KASS:  But I'm simply asking you, quite apart from whether the money is there, so that I understand when we start to fund this research that there might be certain kinds of boundaries that the scientific community wants to respect here even if they're not forced to.

DR. SINGER:  First of all, I think it's incorrect to assume that there aren't considerations about the kinds of controls that you might put on this work.  There are.

There are people thinking about it.  There are people thinking about it at the NIH.  People have thought about it before.  We, in fact, have guidelines that were prepared, but are not operative.

I don't think it's true that no one is thinking about it or willing to think about it.  I think they are.  But they will think more urgently if they imagined that they could possibly carry out the research, and I think that's quite normal.

And with respect to the second point that you raised, I tried to say that I thought that putting aside questions of safety and so forth, scientists are willing to reflect societal values in restrictions and control on research, so long as the societal values are very widely held and there's wide agreement about that.

And I think one of the problems in the current situation is that we don't have that kind of wide agreement.  And I gave the Congress, just as an example, one piece of evidence for the fact that we're stymied over what appeared to be irreconcilable views.

CHAIRMAN KASS:  Well, thank you.

Michael Werner, please.

MR. WERNER:  Well, I think a couple of things. 

First of all, I do think that, by the way, protecting human subjects in research in many ways is about dignity, and I think — so I wouldn't make quite the dichotomy you made.

I do think that's an important thing, and it is about the dignity of patients and about people involved in research.

And then as to the other part of your question, our companies have essentially in various contexts called for ethical review of our work.  The one I'm thinking about actually has to do with protecting human subjects, which is - It came about in the debate about HIPAA and privacy regulation, where our industry essentially took the position that even research that was not covered by Institutional Review Board review, which is, of course, at least in part an ethical review of a protocol, should, in fact, be overseen.

So I think that's one issue, one time.  Also, there's a moratorium on germline gene therapy, genetic modification of the germline in the scientific community now which is something we certainly support.

We certainly support other legislation and regulations that have to do with use and disclosure, for example, of genetic information and, of course, a ban on reproductive cloning.

So I think there are situations where we've either accepted oversight or accepted limits on how far research should go or how it should be conducted to ensure that it's done ethically.

CHAIRMAN KASS:  Would you like to comment?

MR. MANGANIELLO:  You know, I'm neither an economist, to talk about goods and services, nor am I a scientist, nor am I a regulatory lawyer.  I'm just an advocate for patients.

But I was raised with a certain set of values by my parents, who were raised with a set of values by their parents, and I think our scientists in many ways -  if you're asking in lieu of anything in terms of self-regulation, I think that we aren't a nation of mad scientists.  I think we're a nation of people like Maxine Singer.

I attended the ISSCR meetings that are happening here in the city right now.  Probably 500 of the most brilliant stem cell researchers in the world are gathered here in the city right now, and in lieu of a regulation, they had an ethics panel with great thinkers and religious leaders, and the order given to the scientists was: We need to start regulating ourselves.

So I have all confidence that in lieu of regulation, which we look for and are hoping is going to happen through the federal government, that our good scientists will hopefully regulate themselves.

Thank you.

CHAIRMAN KASS:  Let me follow up just one on this side.

There are a couple of areas in the area of sort of reprogenetics that - let me just be hypothetical.  Questions about prolonging the gestation of human embryos ex vivo or chimeras involving human and nonhuman embryonic material, are these kinds of questions that you think deserve public decision?  Should scientists simply be free to go ahead and do these things on their own?

I mean, I'm trying to pick certain kinds of things which are out there which are being explored.  The public doesn't even know yet that they ought to have an opinion about these matters, and we're going to wake up one day if the profession doesn't somehow say to itself, "Look.  You  know, these things are coming.  Maybe we should watch our step here," and as in the case of germline modification where I think the objections are at the moment primarily those of safety at least to begin with.   There is, it seems to me, for the time being agreement.

But could you take it one step further if I offered those sorts of things?  Are there people talking about that as opposed to certain kinds of large things like respect of human autonomy?  But to dig in really in this area and say, "Here are things that are coming along the way.  We're not going to do it until we bring this question to the larger public and find out what the public wants done here."

Dr. Singer.

DR. SINGER:  I'll make a comment about that.  As I think you and I have talked about this before, I don't think that anyone knows that you can clone, do reproductive cloning, on a human.

CHAIRMAN KASS:  Right.

DR. SINGER:  The latest information has to do with a description of at least one of the explanations why attempts to clone non-human primates has not worked, and it's a complicated biological explanation.

So we don't, in fact, know.  We know that our nearest neighbors so far have not been amenable to the techniques that gave rise to Dolly and other cloned animals.  So we don't know whether that would work.

So for scientists involved in that kind of research to be worrying about the modification of such cloned blastocysts or whatever you want to call them, when they don't even know that the whole thing will work, it's just not likely, and I don't think it's because they would shy away from it.  They haven't shied away from a lot of other things.

But my colleagues are very much here and now, and we worry about what's here now, and that's very far- fetched.  It's a bit like science fiction at the present time.  So nobody is likely to be worrying about it a lot, but they will worry about the other kinds of things that we talked about.

MR. WERNER:  Yeah, if I could echo that.  It's similar to what I was going to say, and I think there's also a little bit of a chronology question, which is, you know, are you suggesting, sort of, things don't happen until there's a public vetting and some kind of societal, maybe, consensus or are we saying that sort of as things progress and as research moves forward and if these things become more real, then there should be some public discussion about them.

I think, speaking for our scientists, I think they would agree with what Dr. Singer said.  And also having said that, I think, you know, public discussion, public awareness about ethical issues as research goes forward, I think is important and I think our industry does, too, and so we certainly wouldn't hesitate to participate in discussions about the ethics of certain research.

But I think for some of the things that you mentioned and things like that that are so far out there, for a lot of our members it does have a little bit of a, you know, science fiction quality which is, you  know, it's way out there.  Is that happening in - Where is that happening?  How many people are doing it?  Is that something that's real?

CHAIRMAN KASS:  Okay.  Let me turn to the other - Janet, sorry.

DR. ROWLEY:  Let me just intervene here because I'm concerned about both some of the questions and also some of the comments.  I think it's extraordinarily important to emphasize, firstly, in the report of the National Academy of Science published in September 2001, and I quote, the academy said, "The panel stresses that a broad ethical debate must be encouraged so that the public can be prepared to make decisions about these issues."

So to say that scientists have been trying to cut off debate is, I think, not a fair statement of the situation.

And I again emphasize that it was the scientists who recognize the potential problems with recombinant DNA technology and who themselves declared a moratorium in 1973 and developed what became the Recombinant DNA Advisory Committee, the RAC.

I think both the academy and all of the scientific reports that have taken place have all said that this must take place in the context of appropriate, careful review for the science as well as the safety and the ethical issues of any kind of research that went forward.

So, again, to say that scientists are running away from and trying to avoid regulation is not a correct statement of the facts.

CHAIRMAN KASS:  Could I turn the other question around to see if I could get the response before we leave the scientist side of it?

Could I get a response on the other side?  And then Michael will follow up.  Richard Doerflinger, Bill Kristol, Andrew Kimbrell, a question to you.

Right now we have nothing, relatively speaking.  We have certain restraint having to do with the absence of funding, but otherwise things proceed as people wish, and I'm not suggesting that there are mad scientists or rogues, but there are things that are proceeding that affect all of us, and they proceed in private places, and that's partly because people don't want to countenance this activity sufficiently to see it brought under regulation.

Is that a problem?

MR. DOERFLINGER:  Well, I think you might be understating what's happening in policy circles, because certainly regulation of privately funded research has generally been a matter for the states.  The federal government has in the past gotten into it mainly by way of federal funding.

And in the states a number of things are happening —  some new laws against research in which embryos are destroyed; some new bans on cloning.  The bans that have been passing in the past year or so are chiefly complete bans on cloning in Iowa, Arkansas, North Dakota, and so on.

I think the area for even federal regulation is fairly broad, and I think of the restrictions that could be placed by the federal Patent and Trademark Office on patenting human organisms.  Can we agree?

I believe I've seen a letter from BIO to a member of Congress saying that BIO is against patenting human embryos.  A point of agreement.

There are opportunities for the FDA and other federal agencies to use the interstate commerce clause to look at th interstate trafficking engaged in by the fertility industry. The ways in which success rates are hyped to couples, the ways in which first women are superovulated, then multiple embryos produced, many frozen without informed consent from the parents, many parents left wondering after the fact, "why didn't I think about this beforehand, about the fact that I now have five or ten or fifteen frozen embryos?"

There are regulations in Louisiana based on respect for the life of the embryo that limit some of these practices. 

There are laws in Europe that limit, for example, embryo freezing.  There is a move towards freezing unfertilized eggs instead of the already conceived embryo, which somewhat reduces the ethical problem there. They are limiting the number of embryos that could be produced at one time or placed in the womb at one time.  There are limits on using embryos for experimentation or on creating only for experimentation.

These are all things I think can be done at the state level, but also things that the federal government may have a hand in, and I think that the federal government has a role in looking into those things even without funding any of this.  I think the new documentation on increased birth defects from IVF is a cause for federal agencies to look at IVF, and see whether it is being oversold unnecessarily to couples who may benefit from far less radical procedures that don't pose these risks of increased birth defects.

But I think the range of possible regulation is available.  I think that any road into that regulation that starts by saying the first thing we have to do is contradict  the longstanding congressional judgment from 1996 against federally funding research that destroys embryos, is going to be a nonstarter.  I don't think that's the way to show your moral high ground to start regulating the industry.

CHAIRMAN KASS:  Either of the two of you want to comment on this?

MR. KIMBRELL:  It's a very important question, and a difficult one.  I do have to just spend 30 seconds saying some of the examples you were giving as far as patented embryos or human fetal organs in animals, these are happening.  They're not science fiction.  They're science facts.

So you were actually not bringing up a hypothetical, as you probably know, but actual facts, and scientists are working with those, and to my knowledge haven't questioned the ethics of those in any published journal I've seen.

It's very instructive if you go back to 1987.  A firm called Hana Biologics out of Alameda, California decided to try and get FDA approval for fetal organs as medical devices.  Which allowed them not only, of course, to patent these devices, but to sell them.

That was a fascinating moment actually in sort of reductionism, and particularly giving a legal definition of fetal organism as medical devices.  So we filed a petition with Dr. Otis Bowen, who was running HHS for the Reagan administration, and believe it or not, the HHS even in that administration said, "We actually think that they really should be regulated as medical devices, and that that's appropriate."

We were concerned with that and threatened them with litigation, and they kind of retreated on that.  And then we went to Senator Gordon Humphrey, and we had exactly the kind of conundrum you're talking about, Mr. Chairman, which is that Senator Humphrey, in light of his pro-life constituents, said, "Wait a minute.  If we say," which is what we were asking him to do, "if we add fetal tissue to the Organ Transplant Act saying you can't sell it, then a lot of our constituents are going to say that doesn't make it right because we don't think it should be used at all because we're pro-life.  We don't think that should be something we should use, aborted fetuses for transplantation."

We went to Senator Kennedy's office, and he said, "Are you kidding me?  If we elevate fetal tissue to the level of other human tissue protected from sale under the Organ Transplant Act, couldn't that be the beginning of the diminishment of Roe v. Wade?"

And I said, "Now, wait a minute.  If both of you guys succeed, we're going to have an open sale of fetuses in the United States where economically disenfranchised women are going to be selling fetuses to the highest bidder," and it wasn't a hypothetical because that was during the middle of the surrogate motherhood issue, and we were representing some of these surrogate mothers where they were doing that with babies.  They are actually...So this wasn't, again, theoretical.

Finally, actually I'll give Vincent Ventimiglia as a wonderful activist on the Hill and who was working with Senator Gordon Humphrey then.  He got all of the sides to agree that you have to give up on this position if you're going to have adequate regulation.  If we're not going to have the sale, everyone is going to have to give a little.

And everyone did give a little, and that was passed in 1988.  So there's an example of where it can work.

And in this regard, again, the Davis v. Davis case, and again, I'm speaking now not as an ethicist.  I mean, was it Thomas Aquinas who said that abortion isn't murder; it's frustration of God's will?

These are very difficult questions, which an administrative law lawyer has very little grasp on.  I find them fascinating, but a little knowledge is a very dangerous thing.

But the one thing I do know a little bit about is public policy, and I know that in this current context, for example, in cloning we are at a deadlock exactly for that reason, and I could dispute what Dr. Singer was saying about, you know, the regulatory aspect of that.  We can save that for another time.

But I do think that the Davis v. Davis case should be of interest.  I'm not saying this is something I personally agree with, but I think it might be important as a context here.

The Davis v. Davis case was an argument about the disposition in a divorce case of embryos.  Right?  They had frozen embryos.  During a divorce does Mom get them or does Dad get them?  This is the fight, right?

And they went to the lower court.  It was a pro-life judge, and he said these embryos have the legal status of people.  We can't treat them as property in a divorce settlement.

The husband appealed because that wouldn't have worked for his side, and then the appellate court said the opinion is completely invalid.  It violates Roe v. Wade, and these embryos are merely property.  They're not different than hair, semen, blood, any other biological product.

Well, the wife appealed and it went to the Supreme Court of Tennessee, and they came up with sort of a Solomonic thing, which again I suggest would be of interest to this Council, which is they said, and I'm quoting now, "Pre-embryos are not, strictly speaking, either persons or property, but occupy an interim category that entitles them to special respect."

And this has been called a special entity.  By the way, the State Supreme Court of Massachusetts and others now have followed this.

And the idea of the special entity that they talked about is that this is, again, a human life in potential, an adult human life in potential with a trajectory that, therefore, differs from hair, differs from blood, because this could become a human life.  That is something absolutely different from any other biological product.  It should be distinguished from those products and given respect.

Now, that's the context for discussion, Mr. Chairman.  It's not the answer to what you then do with that context.  I suggested in my remarks that I think some of the things you need to do is if this is human life in potential, this special entity certainly shouldn't be sold.  It shouldn't be patented, and I think it certainly deserves respect and should never be created solely for its own economic exploitation and destruction like some other product.

I think those would be minimal things that  this special entity status would grant it.

But perhaps that special entity status is a way of bringing some of the ethical norms into this, not in a way that many of us would morally agree with on one side or the other, but to provide a context to break some of the ideological deadlock that I think you correctly talked about and that certainly is currently blocking our legislation on cloning from passing.

CHAIRMAN KASS:  William.

MR. KRISTOL:  The ideological deadlock in cloning hasn't got much to do with funding or regulation really.  I just think there are legitimate arguments about bans, moratoria, regulatory structures.  There are legitimate arguments about funding mechanisms as a matter of public policy, whether the federal government or state governments, I suppose, should or shouldn't fund various medical research.  Those are debated every day, week, month and year in Congress.  They're not necessarily hinged together.

We regulate.  We legislate against, and have huge regulatory structures to govern industries that do not get federal funding or don't directly get federal funding, and conversely, we fund things that we then regulate extremely lightly, you know, just to make sure that the money is used for whatever it's supposed to be used for, but with very little substantive regulation.  You know, college student loans would be an example of that.

So I don't think there's much to be gained frankly from sort of a complicated, alleged tradeoff of funding and regulation, though I mean if someone wants to make a precise argument about what we're talking about, I guess I'd be interested in it, but it's not the issue on cloning.

And if you look, it seems to me maybe it would help just a second to separate two things.  There are two, it seems to me, sets of issues that have come up in our discussion here in this panel.  There is the current situation and whether legislation should reform, restrict, change the current practices that go on.  We have right now, as I understand it, selective reduction of embryos in IVF clinics that is entirely legal and unregulated.  Is that a good thing or not?

This is not a "Brave New World" issue.  It is not a scientific progress issue.  It is a current practice and one's judgment on it, I suppose will depend on one's judgment about how much respect one wants to give nascent life or the embryos.

So you can't avoid an embryo debate on a lot of these issues because what is being debated is how much weight to give the embryo.  It's that simple.

So that debate should be had.  One could then raise constitutional issues if one tried, for example, to ban this, but that could be argued out like any other piece of legislation before the court.

So there's sort of the current situation, which I think does largely depend on how much status one has to give the embryo.  The fact that the society disagrees on that doesn't mean it shouldn't be debated.  We disagree on all kinds of things, and that's why we debate them.

We didn't agree on civil rights in 1957 or '60 or '64, and we didn't agree on the war, and we debate all of these things.

The second set of issues is different, which I think germ-line modification, as Dr. Singer suggested, is perhaps a good embodiment of that, but there it seems to me actually from the point of view of democratic theory or democratic practice, frankly, aren't acceptable that any group no matter how well meaning, well educated, and public spirited, through self - I'm not saying that Dr. Singer was suggesting this, but if this were to be the model for the future - through self-regulation or voluntary regulation would resolve an issue of this magnitude, I'm not even sure what I think about - I'm not so sure I think all germ-line modification should be banned.

But in any case, if we don't as a society not only get to decide on this, but have to decide on this, then what are we?  Then we're leaving to professional groups the most fundamental decisions about the future of the human race?

I can't choose to delegate certain things as we often do to professional groups under some general legislative guidance.

So there are the kind of current issues, which I think are legitimate issues for debate.  Are we morally behaving as well as we should?

And I think there I'm not happy with the status quo, but others can defend it and we can argue that out.  Many of those do depend on the status of the embryo.

And then there's the sort of future genetic revolution sorts of issues, but there I think you absolutely need to have public policy, and I don't think anything there hinges on funding.  That's just a question of what we're going to permit and what we're going to encourage, and what we're not.

CHAIRMAN KASS:  Thank you.

Michael Sandel and then Gil.

PROF. SANDEL:  I'd like to pursue and push and sharpen Leon's question, and to do so, first of all, I think Bill is right.  We should put the issue of funding to one side for the moment.  I understand, and I'd like to direct the question to Mr. Doerflinger.

I understand you don't want to regulate practices you object to at the price of federal funding.  So let's put that issue aside.

What I'd like to explore and I think was the spirit of Leon's question was not the tradeoff between regulation and funding, but an ethical dilemma about regulating a morally objectionable practice.

There's no federal regulation on ART in this country or on embryo research or on reproductive cloning, federal regulation restriction, and one of the reasons for that is not just because the libertarians and the free marketeers and the scientists and the patient advocates are so effective.

One of the reasons is that those who object in principle to those practices hesitate to support regulation out of a concern that to favor regulations of those practices would be implicitly to condone them, to confer legitimacy on them.

So it's not funding, but it's that feature of the hesitancy that I want to explore.

So the question is:  Is it ever justified, do you think, to regulate a practice that you consider to be morally objectionable, or does that carry the moral taint of complicity, that you become complicit in the practice?

So, for example, would you favor a federal regulation banning the use of PGD for non-therapeutic sex selection, or would you not favor that out of concern that you consider PGD morally objectionable to begin with, and to ban that particular application of it, though it would prevent some wrong, would implicitly condone underlying wrong?

Now, I can imagine one possible reply might be, no, we wouldn't want to ban that because we consider it so wrong any more than we would want to participate in regulating slavery, regulating the worst abuses of slavery, because that very regulation would implicitly accept and make us complicit in the underlying practice, the evil of slavery itself.

Yes, we might be able to eliminate some suffering, but at the cost of endorsing implicitly the practice.

So is it more like slavery or is it more like another case?  Consider prostitution.  Where one might consider prostitution morally objectionable, but in a case of an epidemic of sexually transmitted disease, the question might arise:  would you favor regulating prostitution for its health effects to alleviate the epidemic even though that might implicate you morally in condoning a practice by recognizing it publicly?

We're not talking about federal funding of prostitution.   We're just talking about the price you pay of a certain implicit -

So the question is:  are these -

CHAIRMAN KASS:  Go ahead.

PROF. SANDEL:  So with those two, with the slavery case, is it more like slavery or is it more like prostitution?  And here's the case I'd like you to address:

German federal law limits the number of embryos that can be created in IVF.  Would you favor federal regulation to restrict the number of embryos that can be created in any given cycle in IVF?  Would that be more like slavery or more like prostitution?

MR. DOERFLINGER:  I might surprise some members of the council by saying even if it is like slavery, one could morally seek to regulate it if that's the best we could do.  That's what Abraham Lincoln did, and his whole campaign theme was "I want to keep slavery from spreading to the territories.  Leave it where it is.  Don't expand it."

And of course, the abolitionists were very distrustful of him because of his middle position.

Let me answer your question in two ways.  One is that I think there's a discussion of this very point on page 15 of our prepared statement, which goes into this and provides some sources.

I like the word "hesitation" that you used, for this reason.  It's not immoral, if it is the best that one can do, to regulate against the most egregious abuses of an industry, even if the industry itself is morally objectionable.

A single example for the Catholic Church would be that we have supported clinic regulations at abortion clinics, to at least limit the damage done by that industry.  Sometimes those laws only limit the damage that might be done to women and not to the unborn, but it is still worthwhile to prevent damage to the woman, and I don't think that those regulations and informed consent requirements, waiting period, parental consent requirements, and so on, condone the underlying practice.

There are some pro-life groups who disagree with us on that, but Catholic teaching is pretty firm in saying that if it is the best that can be achieved, you may limit the worst and most reachable abuses and then build for a more just society in the future.

The reason why there is hesitation is not that it's immoral to support such laws, but because one has to support them in a certain context.  Otherwise one creates scandal by leading people to think, even if it's a misimpression, that that is one's ultimate goal or that is one's ideal. That is one reason why, having raised some particular points and particular deficiencies in current law at the end of our document, the Bishops, Conference says, "We'll be very interested to see what you produce that we can react to," to see what range of regulation and law the Bishop,s Conference can support, now that it has been offered and is the best that there is a consensus can be done.

Does that make —

PROF. SANDEL:  Yes.  Just a quick follow-up. 

Would you extend that line of reasoning to support a law that banned reproductive cloning by outlawing implantation of the product of SCNT?

MR. DOERFLINGER:  That is very different, because we actually don't think that implantation in a womb is or should be a crime.  It's actually what embryos have been doing for many centuries, which is why any of us are here.

It is a completely misdirected law in our view.  What it does is, it allows the cloning procedure — which I know I'm not supposed to call "cloning,"  I'm supposed to call it SCNT whenever people want to do it, but it's cloning.  It's the cloning procedure. You know, those whom the gods of science would destroy they first call by an acronym, but SCNT is cloning.

So you do the cloning procedure, without meaningful limit, and then you regulate the consequences, in a sense, of that wrong procedure by doing a second wrong, which is to make it illegal for that embryo to survive.

So in our view that's two wrongs claiming to make a right.  It's worse than no law at all, and that's why the impasse.

If that were simply a partial law that regulates against the worst evils, we could in principle support it. But we don't think the birth of a baby is an evil.  We think the cloning is the evil.

CHAIRMAN KASS:  Gil Meilaender.

Just so that people know where we are, we started a little late.  You took some extra time for food, and people want to get in here.  Ten minutes and we'll break.  We'll run five minutes over here.

Gil Meilaender and then Robby.

PROF. MEILAENDER:  Well, there are so many things by now actually that one might want to talk about, but I want to say a word about something that Dr. Singer first brought up, the National Academy's report on cloning, and then Janet quoted from it, because I don't think enough was said about it by you, Dr. Singer, to sort of get to all of the issues.

Let me say what I think the "more" is, and you may wish to react.  As you point out, the Academy report supported a prohibition of what it called reproductive cloning, and it said that on safety grounds, given the results in animal studies, that prohibition was warranted, but that even if at some point those studies became more promising, there should be a wide public debate on the moral and ethical questions before proceeding with what it called reproductive cloning.

In the case of what it called nuclear transfer to produce stem cells, but which we can just call research cloning here, it was prepared to support going ahead because there weren't safety questions of the same sort.  We understand that.  If you're not going to implant the embryo certain kinds of safety questions can't arise.

But it did not say -  and this is the thing that you left out - it did not say that a wide public debate on the moral and ethical questions should take place first.

And it seems to me it's important to ask why not.  If in the case of what's called in the report reproductive cloning, even were it safe, a wide ethical debate in the public should take place before proceeding.  Why in the case of what we'll call research cloning, even if it doesn't raise certain sorts of safety questions, should that same public debate not take place before we simply assume that we may proceed with it?

It seems to me that that's the question that needs answering and that you didn't get to, and I'd be glad to hear you comment on it.

DR. SINGER:  So I can't resist just saying that I'm going to talk about nuclear transfer.  I think that abrogation of the word "cloning" in general has been a big problem.  It used to have a completely different meaning for those of us in biology, and so I don't talk about "research cloning," but I understand you when you do, for sure.

So I think that one reason why that wasn't said in connection with nuclear transfer is that there was not a sense in that panel that that raised any ethical or moral issues that would be debated.

PROF. MEILAENDER:  Don't you need to broaden your horizons at that point?  I mean, if the burden of your testimony to us has been that scientists are interested in these questions, that they don't want to short circuit such debate, that they're interested in having it take place, I mean, how could one suppose that this was not a live moral question?

DR. SINGER:  Well, it's very clear that the question about reproductive cloning raises issues that are moral and ethical issues.  But I would need to turn it around and ask you to define for me what you think the moral and ethical issues are for nuclear transfer when we have no idea in transferring a human somatic cell nucleus into an enucleated egg whether there's even the potential for this to become an organism.

PROF. MEILAENDER:  If I even embarked on that, the Chairman would want me to stop, but I don't think it's crucial for me to try to sort out those things right now, but simply to say that I simply report that I have a hard time taking seriously the report that scientists want to engage in widespread discussion of the ethical issues if you're telling me that you don't even find here a moral question.

I just have to report that to you.

DR. SINGER:  Well, unfortunately I think that tells us something about just how difficult these disagreements are and why they are so difficult to resolve.

Dr. Rowley rehearsed for you various steps that the scientific community has taken over many years, and there are many more examples where scientists have certainly been willing and have, indeed, taken the initiative to face issues where there were clearly issues among which even scientists disagree because they are people like everyone else.

But I think in this particular instance, certainly speaking for me personally, I don't understand what the issue is.

CHAIRMAN KASS:  Dr. Singer, I just point out that the Council report with one exception, however people came down finally on whether to favor cloning for biomedical research or not, all members but one thought that there was a moral issue and that the other side had something to defend, and I commend Chapter 6 of our report to you and your colleagues, a chapter which was approved by everybody.

DR. SINGER:  So, again, I'm speaking just for myself.

CHAIRMAN KASS:  Of course.

DR. SINGER:  I have read the report.  I did not understand those arguments.

CHAIRMAN KASS:  Come to dinner.  We'll work it out.

DR. SINGER:  Every time I have dinner with you, I get in more trouble.

CHAIRMAN KASS:  We won't tell anybody.

Let's me see. Robby.

DR. GÓMEZ-LOBO:  One sentence.

CHAIRMAN KASS:  Yeah, please.

DR. GÓMEZ-LOBO:  Let me try in one sentence to explain the moral problem.

Dolly was created by, generated by somatic cell nuclear transfer, and she was a sheep.  A human being generated by somatic cell nuclear transfer would be human.

DR. SINGER:  Well, I don't disagree with that if you make a whole organism, but we don't know that you can make an organism, and moreover, I've made it very clear that both personally and in terms of the COSEPP report, we believe that trying to do that should be banned.  No question.

DR. GÓMEZ-LOBO:  No, I was referring to the embryo. You get a human embryo through somatic cell nuclear transfer with a human ovum and the whole set of 46 chromosomes.

DR. SINGER:  And that's where we part.

DR. GÓMEZ-LOBO:  I'm sorry?

DR. SINGER:  And that's where we part.

DR. GÓMEZ-LOBO:  Well, that's what generates the moral problem.  I mean, even before our ways part, that's where the problem lies.

CHAIRMAN KASS:  We at least see where the discussion has to go.

Robby George has the last question and then we will break, please, and let's try to keep it modest.

PROF. GEORGE:  Okay.  I'm going to try to set a -

CHAIRMAN KASS:  Just no 30-minute cross-examinations.

PROF. GEORGE:  Okay.  Before turning to it, just to make sure I understand, and I won't argue with you, Dr. Singer.

PROF. SANDEL:  You did understand.

PROF. GEORGE:  Just to make sure.

Are you arguing that it's unclear whether we have an organism at the blastocyst stage when that blastocyst came into existence by nuclear transfer, although we would be clear that we have an organism at the blastocyst stage if that organism came into existence by gamete union?

Is it the nuclear transfer that generates the doubt about whether we actually have an organism or is the position indifferent as to whether the means is nuclear transfer or gamete union?

DR. SINGER:  So for any normal gamete union we don't know if we have an organism?

PROF. GEORGE:  That's what I'm wondering.

DR. SINGER:  There's a certain probability that we have an organism, and we don't actually have as good numbers as we would like about what percentage of fertilized eggs, eggs fertilized in vivo in a normal way, what percentage of those actually make it.

We know that it's probably not more than 50 percent.  Okay.  So that's -

PROF. GEORGE:  Yeah, but my only question, just for clarification is -

DR. SINGER:  Well, you called a blastocyst an organism, which I would never do.

PROF. GEORGE:  Whether it's gamete union or nuclear transfer.

DR. SINGER:  Right.

PROF. GEORGE:  That's all I wanted to know.  So either way it's not -

DR. SINGER:  So either way -

PROF. GEORGE:  It doesn't have to do with it being nuclear transfer.  It's just however it came into existence, you're not going to call that an organism.

DR. SINGER:  Either way, either way you don't know for any given blastocyst what the probability is that it will become or has the potential to become a full organism.

PROF. GEORGE:  Okay.

DR. SINGER:  And what we do know is that those that are made with other mammals other than humans, the probability of becoming a complete organism when it's done by nuclear transfer is very low, and for many mammals we have very hard data.

PROF. GEORGE:  Okay.  I think I understand the position.  Thank you.

A question for the two Michaels.  It's something that Bill Kristol raised, and I'm grateful for the opportunity to raise it with you, and I really would appreciate your candid reply to it.

Again, I won't argue with you.  I just want to know sort of where you stand on this.

Mr. Kristol raised the issue about a kind of moving of the goal posts that went on.  Bill Hurlbut has raised it in the Council before.  In the run up to the President's stem cell decision of August 2001, there were a number of people both in the political field and among scientists - now everyone is just speaking for himself, I'm not accusing anybody for speaking for any organization - who advocated, who defended the change in the law to permit funding of embryonic stem cell research and who at the same time said that, of course, they would not be in favor of creating embryos by whatever method for research involving their destruction, but they wanted to use embryos that would otherwise be wasted, as they would characterize it.

Well, then it was months later when some of these same people changed their position in favor of creating embryos for research.

Is it, therefore, fair - isn't it fair - for those of us who are critical of the position that you've adopted here to at least ask and get an answer to the question:  What is the limit of what is being asked for?

Is it not fair to ask:  Are you saying that you're in favor of embryo research and funding on embryo research ought to be permitted to the blastocyst stage, to the 14-day limit, implantation?

Is it possible for you to take a firm position on exactly where you would limit funding for embryo research?  What degree of development of nascent human life would constitute the point at which you would say, you would agree, well, no more research then, no implantation, for example, for purposes of research?

MR. WERNER:  I have an answer.  First of all, there was a debate in Congress, as you probably know, in 1998, I guess, also about whatever we want to call it, therapeutic cloning, cloning for research, whatever, and during that debate my organization took the position we've taken subsequently, which is that, you know, we thought the research should go forward.

So I guess in terms of the first part of your question I feel like we were clear, you know, pre-isolation of the human embryonic stem cell and the debate within the Bush administration and all of that that, you know, therapeutic cloning was something that we thought should be allowed to continue.

So I feel like we've been on record about that for a while.  So I don't think we were one of the organizations that you referred to which said what we were saying, this was okay and then, oops, we've moved the goal posts now a little bit; now X.

You know, we've been clear all along that we thought this research would go forward.

And then in terms of the limits, I mean, you know, I think the 14 days is the one that we feel comfortable with.

PROF. GEORGE:  Is that the position of BIO?

MR. WERNER:  Well, I'll put it this way.  We were supportive of the legislation that contains that provision.  So I can't tell you that we've sat around and said, "Gee, should we allow federal funding for 14 days or 20 days?"  You know, I haven't had that kind of conversation.

But I do know that when we have talked about it, we have talked with our researchers in our companies, and we have talked about the various proposals, and especially we have a lot of our folks who are operating in the U.K., and we are comfortable with the 14 days, and as that as a limit.

PROF. GEORGE:  So if there were promising lines of research that would require implantation, you would not be in favor of pursuing those lines of research?

MR. WERNER:  Yes, that's correct.

Having said that, I will be fair and say I think that - No, I think that it's fair to say that, you know, science advances, ethical thinking advances.  We constantly are reexamining our views and our principles.  I think it's okay for us to say we've said it throughout history with new technology.  It's okay to say, you know, this is something that's troubling, but now, you  know, umpteen years later we for some reason feel like, you know, we can reexplore whether that's an appropriate limit.

I will tell you that I have no view that, sure, we're  going to move the goal post.  I would say our view is 14 days because the primitive streak seems like an appropriate boundary, and that's where we are.

PROF. GEORGE:  So for you that's a principal limit.

CHAIRMAN KASS:  For the time being.

MR. WERNER:  Yeah.

PROF. GEORGE:  Well, that's the question.

MR. WERNER:  Now.  That's correct.  No, look.  And you know, for what it's worth, I understand that that's frustrating, and that's why I sort of hesitated to say it, but I do think that that's where we are, and I don't know that it's appropriate to say that limits on scientific research should stay static over the course of decades as things change.

PROF. GEORGE:  But isn't the status of the embryo something one has got to have a principal position on at some point?  The status of developing human life, there's got to be some point at which you say as a matter of principle we're not going to experiment on human beings at this developmental stage.

PARTICIPANT:  I thought you promised not to interrogate.

PROF. GEORGE:  Oh, sorry.

CHAIRMAN KASS:  Yes.  Do you want to comment?

Look, thank you for a really wonderful panel, spirited and frank and lively.

Council members, we start tomorrow 8:30.  Please review the discussion document and you have at your place the information regarding tonight's dinner.

The meeting is adjourned.

(Whereupon, at 5:41 p.m., the meeting was adjourned, to reconvene at 8:30 a.m., Friday, June 12, 2003.)



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