The President's Council on Bioethics click here to skip navigation

 

THURSDAY, June 12, 2003

Session 3: Biotechnology and Public Policy:
Assisted Reproduction and Reproductive Genetics

Pamela Madsen, Executive Director,
American Infertility Association

Mary Mahowald, Ph.D.,
Professor of the Committee on Genetics,
University of Chicago

Robert G. Brzyski, M.D., Ph.D., President,
Society for Assisted Reproductive Technology

Kathy Hudson, Ph.D., Director
Genetics and Public Policy Center

David H. Smith, Ph.D., Director,
The Poynter Center, Indiana University-Bloomington

CHAIRMAN KASS:  The procedure this afternoon, although many of you have submitted things which are longer than what could be read in five minutes, we will stick to the five-minute allotment of presentation.  We will then have the presentations, all five in order.  Council members have seen and read your submitted statements.  So you can presume them as part of our understanding, and then we will have discussion.

And the order is slightly different.  We listed you in alphabetical order, but we'd like to go in the following order, and let me introduce people so that you all know who's here, and then we'll just proceed.

First, welcome Pamela Madsen, who is the Executive Director of the American Infertility Association, to my left.

Mary Mahowald, who is Professor Emeritus of the Department of Obstetrics and Gynecology, McLean Center for Clinical Medical Ethics and the Committee on Genetics at the University of Chicago.

Dr. Robert Brzyski, President of the Society for Assisted Reproductive Technology.

Kathy Hudson, who is the Director of the Genetics and Public Policy Center at Johns Hopkins University.

And David Smith, the Professor of Religious Studies and Director of the Pointer Center at Indiana University.

Welcome to you all.  Thank you in advance, and we look forward to hearing from you, and we'll start with Ms. Madsen, please.

MS. MADSEN:  I was third, but that's okay.

Well, good afternoon, Dr. Kass, and —

CHAIRMAN KASS:  Excuse me.  Might I ask you to move the microphone a little closer or else have someone to amplify this a bit more?

Thank you.

MS. MADSEN:  There we go.

CHAIRMAN KASS:  Yeah.

MS. MADSEN:  All right.  Good afternoon, ladies and gentlemen, Dr. Kass.  I'm honored to speak on behalf of the estimated six million Americans whose lives are compromised and sometimes devastated by infertility.

As the Executive Director of the American Infertility Association, one of the nation's leading patient advocacy organizations and a personal veteran of the infertility wars, I can assure you that our vast community is deeply concerned about the issues raised by this council.

What is at stake here is nothing less than the quality of our lives and for those of generations to come.  This is why any policy discussion of bioethics and regulation of assisted reproductive medicine must have at its core the welfare of the people most affected:  the patients, our children, and the children that we all hope to have.

As a group, we are educated, reasonable, and well informed, and we are persistent, determined to overcome the cruel twists of fate that leave us unable to reproduce without medical intervention.

We would prefer to have what is usually a private matter between consenting adults remain a private decision.  It's our believe that no governmental or religious body should control these uniquely individual decisions.

In my case, it was a leap of faith that gave my husband and me two boys, both IVF babies conceived through assisted reproductive technology when it was in its early years.  Our 14-year-old was made the new old-fashioned way, with Mommy's egg, Daddy's sperm, no micromanipulation, and a fresh embryo transfer.

Our 10-year-old grew from a cryopreserved embryo, held over from one of our previous cycles at a time when freezing and thawing were considered newer technologies.  It was an informed choice, and we knew the success rates at that time were not very encouraging.

Our tenacity paid off with a healthy baby boy who hit is first home run last week in Little League.

We have our family precisely because my husband and I were able to make that most private choice unencumbered by any government, social, and research policy.  The science was sprinting.  This country had taken the lead in finding new ways to outwit, if not vanquish, the disease of infertility.

The technology was available.  It cost, but it was there for us to use, and for that we are eternally grateful.

The freedom to avail ourselves of progressive techniques is what we need.  For those afflicted with infertility, assisted reproduction transcends ideology or electorial politics.  It is about the opportunity to realize the possibility of family.

Yet to our dismay we have been drawn into battles far from our own immediate struggle, and it is the belief of the American Infertility Association that productive medicine is being dragged most unwillingly into abortion politics.

Why?  Because our treatment results in the creation of an embryo. 

However, we all must remember that these embryos are a part of our medical treatment to combat our infertility.  We take issue with the presumption that others can lay claim to what is rightfully ours.  We are incensed that we become the lightning rod of often vicious political debate around what some refer to as, I quote, "excess embryos."

Medical investigators want them for stem cell, DNA, research, disease cure research.  Anti-abortionists want our embryos to be donated to others who want to experience pregnancy.

And those are all perfectly reasonable options, but they are options that belong to us, the individuals who created those embryos.  Every decision about their disposition is emotionally fraught, even the choice to do nothing.  To keep them suspended in liquid nitrogen is hard.  Trust me.  I have four.  They're sitting.  It's hard.

Those of us who have gone through the unimaginable, life-altering experience of assisted reproduction have and should have the right to determine the fate of those three or five cells because their fate is bound with ours.

Unfortunately, we must depend on the intellectual and scientific creativity of researchers and clinical practitioners to develop the technologies that we need.  We expect our elected and appointed officials to help insure a hospitable environment for research and clinical practice of integrity.

We expect our government to take an enlightened approach to the science and encourage it, not impede it.

And we expect those who are weighing in on the most intimate part of our lives to please respect the intimate nature of the infertility experience.

Further, we demand unimpeachable ethical behavior from all because there's nothing on our agenda but children, healthy, normal children, regular boys and girls who make it into this world because we can pursue and should have equal access to a constantly evolving and expanding array of therapies.

To date, more than one million IVF children have been born, and they, for all intents and purposes, are indistinguishable from everyone else, and that is what we want.

You will find few others as keenly aware of the ethical ambiguities of assisted reproductive technology than the infertile.  We struggle with the large and the small philosophical, religious, and moral implications of treatment even before we walk in the door.

We analyze and carefully weigh the risks we knowingly assume before undergoing sometimes still experimental procedures.

How we resolve these dilemmas is as personal and singular as DNA.  We, the infertile, object to the manner in which our disease and the outcome of our treatments are increasingly depersonalized, treated as commodities, as things apart (from) who we are.

Even the language to us is really troublesome.  We hear about patentable human goods when what is really under discussion are patentable technologies.

We hear about embryo adoption as if it was an acceptable legal term, when what really is under discussion is embryo donation.  We worry about the government impinging on individual liberties, our religious and cultural beliefs, by determining for us what hundreds of years of philosophical and scientific debates have not when life begins.

And once again, the infertile have no wish to be roped into that particular debate.

Certainly the infertile community — I'm wrapping up — the infertile community welcomes the help of a compassionate government.  We would deeply appreciate a government commitment to health coverage for infertility treatment for all that need it.

We believe federal funding for research is essential to safely expedite the process and defray the financial burden that now falls squarely on mostly uninsured patients.

And we need solid, long-term studies of the welfare of infertile couples, the impact of the disease on parenting after ART that track the health and development of our children, that yield dependable data from large samples, and still protect privacy.  That is how the government can protect the general good.

We advocate the rigorous oversight of the development and application of assisted reproductive technologies.  Indeed, we have paid richly for the regulation already in place.

However, it has yet to be determined that heaping on more regulations would improve the ethical landscape.  Rather, we believe that government participation in a joint committee of physicians, psychologists, theologians, lawyers, as well as other professionals, and patients, we can strengthen existing mechanisms.

Let us have standardized informed consent and institutional review boards for all institutions involved with experimental infertility protocols.  Let's strive for transparency and openness, and hold people accountable.

We are not naive.

CHAIRMAN KASS:  Ms. Madsen.

MS. MADSEN:  Infertility patients —

CHAIRMAN KASS:  I'm going to have to stop you.

MS. MADSEN:  Just my last two sentences.

We know that there are no guarantees.  We adamantly oppose additional regulation without a concomitant throw of federal funds to underwrite research and support access to care.

We don't want you to slam the doors on all of those who are happy, wanting to have children, and I apologize for speaking too slowly.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Professor Mahowald, please.

PROF. MAHOWALD:  First of all, thank you for inviting me.  I really have looked forward to meeting some people that I've known a while and admire a great deal and meeting a few others whose work I've admired but not have had the pleasure of meeting.

In the E-mail inviting me to this, Dean Clancy articulated a little differently than you did, Dr. Kass, but I think the same questions that you began this session with.  He said:  what values and principles currently do and which ideally should guide the regulation of assisted reproduction in the United States?

Now, this is, in fact, two questions, one mainly applicable to the self-regulation that prevails — that's a descriptive question, I think — and the other applicable to government regulation which would presumably have the force of law.

Now, I was asked to bring to the discussion, and I'm quoting again from Dean Clancy, the perspective of someone who's concerned about the ethical duties owed to women and children to be in the context of assisted reproduction.

So with these concerns in mind, my answers to the questions posed can be put very succinctly.  The principle that guides current practice is the right to have a biologically related child, and the principle that should ideally guide regulation is the principle of justice.

Now, in the longer piece that was distributed to you, I talked about these themes a lot more, although I would not say adequately in less than 3,000 words, but today I just want to highlight some of what I wrote there, and also on the outline that I think you have, I've identified some areas that deserve more regulation than currently exists, and I hope we can discuss some of these later.

In her presentation to the council, Sandra Carson identified three values as central to professional self-regulation:  safety, efficacy, and privacy.  Now, these are necessarily addressed through the basic bioethical principles of respect for autonomy, non-maleficence, beneficence, and the right to have a biologically related child is attributed to potential parents on grounds of the first of those, respect for their autonomy.

Justice, the fourth basic principle of bioethics, serves a mediating or balancing function when other principles or values cannot simultaneously be upheld.

Now, regarding my first answer, the right to have a biologically related child, this is a relative and negative right.  It's relative or contingent rather than absolute because its exercise depends not only on the cooperation of others, but also on factors that may prevent its expression even then.

It's a negative right rather than positive because it only obliges others not to interfere with its expression.  It does not oblige them to positively assist or facilitate its exercise.

The right to have a biologically related child is usually asserted with a crucial caveat that the child be healthy, and in her presentation to the council, Dr. Carson made it clear that the potential child's health is a goal of infertility treatment.

But the right to biological progeny doesn't necessarily entail the right to healthy progeny.  Some patients give priority to health by undergoing preimplantation or prenatal diagnosis to avoid having children who are unhealthy or disabled.

For the potential child it's seldom, if ever, better not to be than to be unhealthy, if these are the only alternative.

Regarding my second answer, even a minimalist approach to government regulation should be based on some conception of justice.  The conception that I would propose draws on the work of Nobel Laureate Amartya Sen.  This view eschews a policy of political correctness that ignores differences, insisting instead on attention to differences that provide advantages to some while disadvantaging others.

It starts from the premise that people are of equal value despite our differences, and it calls for efforts to reduce inequities that are often associated with the differences among us.

Differences that need to be examined to develop just regulation of assisted reproduction include those based on gender, class, age, marital status, sexuality, ability, ethnicity, and moral beliefs.  I won't bother trying to give you examples of all of these, but regarding gender, for example, women obviously incur risky, invasive, and uncomfortable or painful procedures that men don't experience even when the treatment is for male infertility.

Accordingly, women's decisions should generally have priority over those of their male partners if these are at odds, and it should not be assumed without question that the priorities of both members of a couple are always the same.

Regarding class, economically disadvantaged women and couples often don't have access to medical treatment for infertility or they only have access to suboptimal treatment.  The recent cases of octuplet and septuplet births are probable examples of suboptimal treatment.

If the right to have a biologically related child is fundamental, then justice demands that infertility treatment not be withheld from

individuals solely on grounds of their ability to pay for it.

Regarding age, the right to have a biologically related child is more compelling for those who are in their reproductive years, than for naturally and healthy post-menopausal women.  Moreover, if as a society we regard all children as of equal value, a recommendation that supports the right to have a biologically related child should be articulated in the context of a broader and more basic right of children to be parented.

On grounds of justice, the right to have a child already born, regardless of whether the child is biologically related, is more compelling than the right to have a biologically related child who has not yet been conceived.

In a pluralistic society such as ours, justice demands attention to moral differences, and with regard to infertility treatment, many of these stem, as you said, from different positions on the moral status of the embryo.

But U.S. law is clear that a woman has a right to abortion which entails destruction of embryos at least until fetal viability.  If moral differences ought to be respected, clinicians may be, I think, required to offer alternatives consistent with their patient's moral beliefs, and researchers should be encouraged to develop more of these alternatives.

In sum, and to repeat my answer to the question I was asked, the right to have a biologically related child is the main guide to current treatment of infertility, and the principle of justice is the ideal guide for regulation.

Both principles should be supported, I think, in the council's recommendations.  In cases of conflict though, justice should have priority.

Thank you.

CHAIRMAN KASS:  Thank you very much.

Dr. Brzyski.

DR. BRZYSKI:  Dr. Kass, members and guests, I appreciate the opportunity to speak on behalf of the Society for Assisted Reproductive Technology regarding the regulation of ART.

By way of introduction, let me provide some background about the society, SART, as we refer to it.

The idea for SART began in 1985 with a group of professionals who convened an effort to foster development of the field and communication within the field.

One of their first efforts and priorities was to publish an annual report of IVF technology to foster that communication development.

In 1988, the society was founded formally, and that first annual report was published as it has been every year since then by the society.

Today there are approximately 370 member programs of SART that are responsible for the vast majority of the 100,000 cycles of ART and 35,000 babies that are born annually in the United States.

SART's mission is to promote and advance the standards for the practice of assisted reproductive technology for the benefit of our patients, our members, and society at large.  I would state that the explicit benefit we seek for our patients is healthy children.

To meet this mission, SART's activities comprise several varied efforts.  First, the registry oversees the collection of annual clinic-specific data for publication by the Centers for Disease Control, and in fact, the registry was responsible for the development of the current data collection software program that is the basis of that system.

SART provides the validation process which reviews the data quality and accuracy submitted by the programs.  Not just SART members, but any IVF program is required to submit data annually, and that validation occurs by state visits of peers to the programs with chart reviews and reviews of the medical records and laboratory data.

Quality assurance efforts by SART provides a process for assessment and promotion of member performance through consultative services provided by SART members.  The Practice Committee continually develops and reviews guidelines and all aspects of ART, and all members are expected to abide by those guidelines, which include ethical guidelines as developed in conjunction with the American Society for Reproductive Medicine.

I have reviewed the current regulatory landscape as I see it in my invited written comments to the council in April.  This slide shows a summary.  Here I will just emphasize again that today as we meet that there are a variety of regulatory processes operating at the federal, state, and professional level.

In the short time I have, I'd like to point out some characteristics of professional regulations as I see them and provide some observations on the principles that I believe should inform regulation.

First, I would argue that the peer dialogue that is the basis of professional regulation promotes engagement and investment in the issues at hand by all of the parties involved.  Attitude and environment for professionalism fosters commitment to professional objectives.

Second, in contrast to legislative mechanisms of regulation, professional regulation and professional regulatory mechanisms support timely engagement of new issues.  This is important in fields such as assisted reproduction when progress is so rapid.

A final comment I would make is that associating professional performance with economic consequences creates, I believe, an opportunity to influence behavior.  For example, tying participation in a large insurance program by an IVF practice to board certification or professional society membership provides leverage to those boards and those societies to regulate and influence professional behavior.

That being said, I'll just make a few comments regarding principles of regulation which I touched upon, again, in more detail in my written comments in April.

First, I think beneficence considerations obligate an analysis of the cost and benefits of any regulatory schema because in the current environment, patients are the primary bearers of the cost of care.  These costs entail terrible burdens to patients and prevent many from ever receiving the necessary care.

Justice considerations require that regulation not discriminate against individuals based on their inability to reproduce without assistance.  Given the vital importance of reproduction and human life, justice and regulatory objectives are both served by promoting expanded insurance coverage for ART.

Likewise justice and beneficence would be served and a significant regulatory infrastructure would be brought to bear if federal support for ART research were promoted.

Finally, the principle of autonomy requires that reproduction be recognized as fundamentally private, and that this most intimate relationship between couples should not be unduly scrutinized or compromised by regulatory interventions.

As to the future, SART will continue to foster and promote collaborations with various professional organizations, government, and bureaucratic organizations, such as collaboration with the Centers for Disease Control for data collection, collaboration with the Food and Drug Administration regarding  guidelines to inform their oversight efforts, a collaboration with the Joint Commission for Hospital Review and their efforts to oversee laboratory regulation in the IVF field, and collaboration with our patient advocacy groups with whom we have had a rich and successful history.

The final comment I would make is I want to thank the council for bringing this social dialogue to the forefront.  I think that's probably the most important effort that you could pursue, and it's the fundamental basis to make ethical judgments that we understand the social environment, that voices are heard, and that information is collected so that informed decisions can be made.

I thank you again, and I look forward to further progress in the field.

CHAIRMAN KASS:  Thank you very much.

Dr. Hudson.

DR. HUDSON:  Dr. Kass, members of the council, thank you very much for the invitation to speak before you today.

I'm Kathy Hudson, the Director of the Genetics and Public Policy Center at Johns Hopkins University.

The center is a little bit over a year old, and we were created to build tools and resources to help policy makers and the public address issues emerging from advances in human genetics.

Our first project is on reproductive genetics, funded by the Pew Charitable Trusts.  As this committee knows and has discussed, the fusion of advances in genetic science and advances in human reproductive medicine have brought forth new technologies that give parents unprecedented new powers to identify, select, and perhaps in the future to modify the genetic characteristics of their children.

The specific aims of our attention to reproductive genetics are listed here.  We want to understand what the public is thinking about reproductive genetics.  We want to engage them in a conversation about reproductive genetics.

We would like to create objective, comprehensive, and hopefully comprehensible information resources, and ultimately to develop a set  of policy options that can be considered by the public and its representatives.

We will not be creating individual recommendations, but rather, an array of options with robust underlying analysis that can be used by others in making decisions.

Dr. Kass, in the center's written comments, we responded to the council's request for information about the current regulatory and legal landscape.  This morning I would like to make two points.

The first is that I think it's quite clear that safeguarding and improving human health is the key motivation and key principle that guides genetics not only in the research laboratory, but in the clinical context, and similarly reproductive medicine research and its practice.  And yet I believe there are weaknesses in the current system.

Second, I'd like to point out that public participation must be a core principle that guides policy development, process, and choices.

So of the core values or principles that should guide reproductive genetics policy, safeguarding human health is perhaps the easiest to identify, to understand, and ostensibly to address, and yet there are weaknesses in the current system of policy, and I use the term "policy" quite broadly to include research policy, that have significant implications for human health.

As Pam addressed, as did Robert, there are now over a million babies that have been born worldwide through assisted reproductive technologies.  And yet in the United States, we do not have an effective system to monitor the health and developmental outcomes of these children.

There have been a number of studies that have produced sometimes confusing, sometimes contradictory, and often incomplete information about the health status and developmental outcomes of these children.

To make sense of this information, the center this week convened a panel co-sponsored by the American Academy of Pediatrics and the American Society for Reproductive Medicine to evaluate the current medical knowledge and to make recommendations for future research to resolve uncertainties and fill gaps in our knowledge.

The second example of a weakness in the current reproductive genetics policy is the absence of a well paved and clearly marked road that genetic tests must traverse in moving from the research laboratory into widespread clinical use.  While the accuracy, reliability, and interpretability is important for all genetic tests, it is particularly critical in the reproductive genetic testing context.

There are now over 900 genetic tests that are available clinically or that are in development, and it's possible to do genetic testing at virtually every point in the human reproductive cycle.  We can test parents.  We can select gametes based on the presence of sex chromosomes.  We can test embryos, fetuses, and newborns.

In the reproductive context, it is often the genetics test alone that is the sole clinical information available for making important decisions.  Attempting a pregnancy or not, implanting an embryo or not, continuing a pregnancy or not, these are profoundly important decisions, and thus we need to have the very highest degree of confidence that the genetic test results and their interpretation are accurate.

So I believe there are weaknesses in the current system of oversight and policy that result in an inadequate understanding of the health risks of these technologies and an inadequate assurance of the health and safety of their use.

Briefly, on the second point, I would like to propose that a fundamental core principle that should govern the process by which policy decisions about reproductive genetics are made in the United States, and that principle is the public's participation.  The public should have a voice in public policies about reproductive genetics.

The goods and values that are advanced and embodied by policies governing reproductive genetics should be the goods and values that are held most dear by the citizens in this democracy, and yet we have only the faintest glimpse of what our citizens hope for and fear in this new realm.

We don't know largely because we haven't asked.  As you have heard from other speakers during the course of your deliberations, other nations when trying to develop a regulatory framework for these issues have turned to its citizens.  Both Canada and the United Kingdom consulted with tens of thousands of citizens in their consideration of human genetics policies.

The Genetics and Public Policy Center is engaged in a modest effort to understand and listen to the voices of the public.  We took an initial pulse through a survey last fall.  We recently completed 21 focus groups with Americans in five cities around the country, and we're now conducting over 200 interviews with individuals who have special experience, expertise, or perspective.

The themes and hypotheses emerging from this work will be validated and tested in a very large survey of citizens this fall, and in addition, this winter we will be engaging groups of citizens to learn about genetics, to learn about reproductive medicine, to learn about governance, and then provide to us their ideas and input about how we should move forward.

The center will use this input along with our extensive policy analysis to construct an array of options that can be considered as society grapples with the development and use of these technologies.

In closing, I'd like to quote Thomas Jefferson, who certainly had some interesting perceptions of genetics and the nature of families, and he said, "I know no safe depository of the ultimate powers of society but the people themselves, and if we think them not enlightened enough to exercise their control with wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."

Thank you for your attention.

CHAIRMAN KASS:  Thank you very much.

Professor Smith.

DR. SMITH:  It's an honor to be asked to be here, and I'll promise nothing but brevity, and I'll be rather conclusory.

I'm going to talk very briefly about two things.  One is parenting and the importance of children, and the other is embryonic life, which I think are issues the council has obviously addressed, but seem to me to be central.

I'm going to say four things about parenting and the importance of children.  The first is I think it's correct to say that having biological children is a good fortune, a gift, or a blessing rather than a right.

Secondly, I think adoption is an option that should always be presented to and be considered by parents seeking fertility services.

Thirdly, techniques, such as prenatal genetic diagnosis that select among gametes or embryos, may, I think, appropriately be used so long as they're proven safe and respectful of embryonic life.

Fourthly, my intuition is to support regulation by interdisciplinary boards with a professional as well as a lay component, whether they be local or regional.  More general regulations seems to me to be very likely to get things wrong.

With reference to embryonic life, I take the view theologically that it's a kind of vestigial image of God.  It's not to be created to be sacrificed, but unlike those of us sitting around the table, it's usable for research when there's no prospect of implantation or development.  They are, as others have said, potential people, but not possible people.

And I'll stop there and make up for some other time.

CHAIRMAN KASS:  Thank you very much.

Let me start.  I think there are lots of people around the table with questions of their own.  Let me put a couple of questions forward.

This one, I guess start with Dr. Brzyski, if I might.

I'm interested in how the professional standards, especially the professional ethical guidelines established by the society and by SART are forced.  I mean it in the broadest sense.  As I understand it, these guidelines are mostly hortatory, but it's not obligatory that people who are members in good standing, in fact, obey them.

An instance known to both of us, at least one member of the society that advertises publicly that they, in fact, engage in PGD for nonmedically related sex choice.  And yet this is an activity discouraged in the society's own guidelines.

I don't want to argue through that particular case, but if one wanted to trust to professional self-regulation and that there were certain kinds of values or concerns that the profession itself had, how does the profession see to it that its own recommendations are effective or does it and what can it do and what might it do better?

DR. BRZYSKI:  Well, I think that I touched upon a thought, an idea briefly in my oral presentation that I think might need to be explored more, and that's the issue of professionalism and the attitude of professionalism that promotes an environment where individuals are sort of exhorted to participate and to achieve the expectations of their professional colleagues, and that's a rather vague way of accomplishing something, but I think it's something that can't be ignored; that the dismissal of an attitude of being part of a profession as opposed to having a job or having a business; I think that those values and attitudes that go along with the membership in a profession need to be emphasized and form more of a basic attitude and principle with which to deal with each other.

CHAIRMAN KASS:  Well, let me pursue this a little bit.  I mean the American College of Surgeons, the American College of Physicians have certain kinds of norms and guidelines that people who accept membership agree to uphold, and at least in some cases, although it doesn't happen that often, people who sort of flaunt those recommendations, given several opportunities to reform their practice, but since fellowship is a privilege and not a right, the colleges are certainly free to say, "Look.  I'm sorry.  We recommend, for example, that ICSI is a new, relatively unstudied procedure for use in male infertility, but we find it odd that there are some clinics now using it at, say, 85 or 90 percent of cases not related, and that we think that's unreasonable.  Either show cause for doing it, change your practice, or we might have to reconsider your membership in the society."

And the other professional societies, while being collegial, nevertheless exercise more than "please do this," and I wonder whether — I mean, you're a young society relative to those others, and the guidelines are being developed as the field grows, but certainly the coming of preimplantation genetic diagnosis and the uses of those things beyond just reasons of the health and prevention of serious diseases, and sex selection is just the forerunner of this.

It does seem to me that there are things in which the whole society has a stake.  If it is to leave the regulation of this in the hands of the professionals, it wants at least to have some sense that the professionals will see to it that those kinds of norms are, in fact, observed.

If that sounded too much like a lawyer's brief, I apologize, but I'm trying to sort of push the question about what are the limits of professional self-regulation here, not in those cases where, you know, it's certainly obvious that those things should be followed, but in cases where some fellows think, look, the parents want to have a girl child now.  Why not? 

Or they say, "Look.  We want to increase our batting average here.  So we'll use ICSI rather than something else or we're going to start doing this kind of practice though it's relatively untested," and the couples don't mind and they've been properly informed of the risk.

Those are the general areas for sort of professional self-regulation and, generally speaking, enforcement or adherence.

DR. BRZYSKI:  Well, I would say that I would agree that this society is young, and part of the process that we go through as a society is to plot a course of development that will cement our recognition as setting the standards in ART as we have put as our mission.

And I think there's a growing collaboration that's developing over time among several aspects of the ART field.  When it becomes important economically, as I mentioned, for members to be members of the society, then that's one way to leverage behavior, and there are cases now where as I mentioned, insurance programs require that if you're a patient and you're going to seek assisted reproductive technology services, that those be provided by a member of SART. 

That's I would say a minority of individuals that are covered by those sorts of benefits, but if that became more widespread, then that would provide some impetus for individuals to maintain participation.

I would say that the society believes at this point that to try and maintain a communication with members and maintain a membership that could be potentially influenced in the future would be more important than taking a strong stance and depleting the membership based on those stances which have no potential impact on behavior.

DR. FOSTER:  Can I just ask a question in follow-up to this?

CHAIRMAN KASS:  Dan Foster.

DR. FOSTER:  Has ever anybody, since this is a young society, has ever anybody who is a member of the society where peers believe that there has been a practice that's not in accord with the standards, been in any sense counseled or dismissed?

As an aside, as I know you know, the residency programs in this country are controlled by the ACGME, and in internal medicine where I work, for example, there were strong standards about what you had to do to train residents, and so forth, and for years the programs that were recognized as being absolutely disastrous were never closed because of the fears, some of the fears that you just expressed, either lawsuits or that there would be a fallout.

So I think there is some concern on my part that regulation by societies — I mean, what happened is that the professors of medicine, the chairs of medicine, in essence, forced the RRCs to begin to close programs that did not actually meet the standards that were required of everybody.  I mean, we had the situation for a great academic program was put on probation, and at the same time a program in, let's say, Philadelphia or Dallas or somewhere that everybody knew was absolutely no good was not disciplined at all because of fear.

And so the question is twofold.  One, has anybody ever been called, in essence, to account for their practice in the two or three years that you've existed?

And secondly, do you have confidence that without some sort of discipline that might require somebody to lose their accreditation, the absence of that would be  effective?

These are just two questions that I wanted to — I got the sense that you thought that the fact that the membership itself was enough to be sure that everybody followed the programs that you have outlined here.

DR. BRZYSKI:  Well, one example that I can point to is that there are advertising guidelines that the membership adhere to, and when there are variations from those practice guidelines that are brought to the attention of the society, then there is an educational effort that's carried out with those memberships, and there are cases where — and the typical response of the member is to modify their advertising behavior just in response to those educational efforts.

Another case involved sort of the combination of advertising and practice, was utilization of experimental procedures in a clinical setting without documentation or support or evidence that the patients were being cared for in a clinical trial in a research setting with appropriate controls.

So a practice has instituted what professionals in the organization recognized as experimental, as accepted clinical practice, and offered that as a service to their patients, and that membership, after a long discussion back and forth, efforts led to the termination of that membership or that program.

CHAIRMAN KASS:  Michael Sandel.

PROF. SANDEL:  I had two questions, and I'd be interested to hear anybody respond to them who would like to, but I would like to address them initially to Professor Mahowald because the question arises from a distinction that you drew between two rights, the right to have a biologically related child and the right of an already existing child to have a parent.

And you said that the first was implicit in the current regulatory practice, but you suggested that the second was morally more important, if I understood you correctly.

And in your paper you said thinking about government regulation that policies that encourage and facilitate adoption are more morally incumbent on regulators than policies that facilitate infertility treatments, which reflects the priority you would give to the right of already existing children to have parents over the right to have a biologically.

If some limited funding were available in this area, you would say, would you, that given the choice between funding infertility treatment and funding adoption programs, we should do the second before the first.

Did I understand you correctly?

PROF. MAHOWALD:  Substantially, that is what I said.  Basically the right to be parented, the right to be nurtured, the right to be given what one needs to grow, I think, takes precedence over the right of parents to have a not yet existent child.

PROF. SANDEL:  Is there anyone on the panel who disagrees with that?

MS. MADSEN:  I'll chime in in a slightly different way.  I don't know necessarily that infertile people are the only people to adopt children.  Fertile people can adopt children, and putting us together as, well, if you can't have a biological child we'll help you adopt one is our solution.

Children need to be adopted, and people want to have biological children.

PROF. SANDEL:  Well, that addresses a different —

MS. MADSEN:  And they're separate.  And they're separate.

PROF. SANDEL:  That addresses my second question, which I don't think answers the first.  My second question was going to be that.  Is there any reason to think that the obligation to fulfill the right of children, already existing children, to have a parent should fall more heavily on those who are infertile than on those who are not?

You've said no.  The answer to that is no.  Is there anyone who —

PROF. MAHOWALD:  No.

PROF. SANDEL:  You would agree.

PROF. MAHOWALD:  Yes.

PROF. SANDEL:  But those are two separate issues, aren't they?

Though everyone here might agree that the answer to that question is no, that there's no special obligation to fulfill the right of children to have parents that falls upon those who are infertile.  It doesn't equally fall upon those who are capable of conceiving naturally.  So that's one issue.

But to answer that question in the negative still isn't to disagree with the first claim, namely, that the right to have a biologically related child is morally less important than the right of a child to have a parent.

That's why I was trying to separate those two questions and see whether people —

MS. MADSEN:  I think it's very, very difficult when you put lots of different groups with tremendous needs and pain and ask them to compete against each other.  Children deserve homes.  Children need to be adopted, deserve wonderful adoptive families.

People who have a disease deserve treatment, and I hate to be in a society where we can constantly make disease groups and people with special needs.  Real needs that are all legitimate, compete against each other and make us decide who should be cared for.

CHAIRMAN KASS:  I have Gil, Rebecca, Robby George.

Gil Meilaender.

PROF. MEILAENDER:  Yeah, this follows in a way on Michael's question, and I think I'm going to address it, Mary, to you, but I'd be happy to hear from others because I think at some level there is disagreement among the panel on issues.

What I want to think about is what you mean in terms of the right to have a biologically related child or perhaps the right to have a healthy biologically related child, what that language means exactly.

And I realize that in a certain sense at that point in the materials that you submitted to us and in your talk you were speaking descriptively, and so you're not necessarily arguing your own view, but nevertheless, you may be able to kind of think it through with us.

And it goes in some sense to the question about private/public, and how much of this is a private matter and how much is a public matter, in which there was some difference at least at the linguistic level among the panelists.

One of the things is what it means to have a biologically related child.  There are lots of ways to produce them, and the question is whether they all amount to doing the same thing, to having a biologically related child, and to take the example at one extreme, and I believe as I recall you do mention it, to use cloning, to produce a clone of myself might be said to be a means of having a biologically related child.

Now, are you saying that descriptively at the level of our practice right now, whatever you may happen to think normatively, descriptively that I do have a right to have a biologically related child by that means?

PROF. MAHOWALD:  I think people who have argued in support of reproductive cloning use exactly that argument.

PROF. MEILAENDER:  I guess let me follow it up, if I may, and invite others.

Does the fact that some sizable number of people have moral reservations about cloning to produce children suggest that the language of a right to have biologically related children is too broad and needs greater narrowing and precision?

PROF. MAHOWALD:  Yes.

CHAIRMAN KASS:  Please.

DR. BRZYSKI:  I would just comment that I'm not aware of any professional organization or patient advocacy group that's in favor of reproductive cloning to produce children, and I would contend that there are practically no scientists that would equate a clone with a child.

So I would make that distinction.  So the argument that cloning is a way to have children, I think fundamentally is a misconception that practically all professionals that work in reproduction would argue.

CHAIRMAN KASS:  I think if I understand the force of Gil's question, and it certainly is one of the things that springs from this discussion, granted that reproduction is a private matter in the first instance and an intimate matter in the first instance, and we generally believe that government has no business interfering, and some people even think government has an obligation to help where there are obstacles to realizing these private goals.

The question is whether the presumption of privacy and the rights to be exercised in that private realm are unqualified and embrace also having a child by whatever means, having a healthy child, which is very different from the right to have a child, and having a child with certain desirable characteristics.

Look.  If it weren't for the coming of the new genomic knowledge, I doubt that we would be having this conversation really.  I mean there are questions to be raised about the adequacy really, the concerns for the well-being of the child-to-be who is produced here, who is also a patient of this procedure, but invisible to the eye and merely hoped for when you get started, though that being is the patient of the operation and that person's well-being and safety was an uppermost consideration  not always regarded in advance.

But I don't think we would be having this conversation were it not for the fact that new kinds of choices now begin to enter into the right to have a child or the privacy here where the society might have an interest.

I mean, look.  You've got other nations where they practice sex selection not by PGD, but by sonography and abortion, and the sex ratio at birth approaches 120 males to 100 females.

Those are aggregated private choice with enormous social consequences, and the society can't be indifferent to whether that goes on and how it's practiced.

So here is an instance where one wonders whether or not the language of rights, the language of privacy, given what's coming before us, is going to be adequate to deal with the implications of what's here.

And that's partly why, while I share your starting point, I wonder whether from the social point of view all of the things that are of interest to us and that we all care about are adequately simply handled in terms of the language of rights.

And I think Gil's question is meant to probe the limits of that concern.

I'm sorry for jumping the queue, but I think it that's where we're —

PROF. MEILAENDER:  Thank you for the assistance.

CHAIRMAN KASS:  Yeah.

(Laughter.)

CHAIRMAN KASS:  I have Rebecca and then Robby, then Bill May.  I'm sorry.

PROF. DRESSER:  One of the major concerns in this area is when the prospective parents who, of course, are very much interested in trying to have children might have preferences that conflict with the well-being, particularly physical well-being, but also other kinds of well-being of our future.

So Leon just mentioned that this future child can be considered a patient.  So I was interested in whether you all agree with that.  Do you think that the to-be child or hoped for child is considered a patient, and if so, what safeguards should be in place professionally and perhaps in an oversight capacity from the government to handle situations when there is a conflict of interest between the prospective parents and the child to be?

And I guess the easiest thing to talk about would be a physical threat, and so let's look at ICSI.  That's a procedure which some people still have some questions about in terms of whether it's producing healthy kids, and it's not being studied in a very rigorous way.

And this would certainly be a case where many prospective parents might say, "Well, if it raises my chance of having a child, I want it, and don't make me go into a clinical trial or don't make me wait for the clinical trials and the data.  I want it now."

And, you know, that's perfectly understandable, but should there be any kind of oversight there?  What should the role of the physician be in that situation?

CHAIRMAN KASS:  Is that addressed to someone in particular?

PROF. DRESSER:  No.  I just wondered if anyone in the group had views on this.

DR. BRZYSKI:  Well, my microphone is on.  So I guess I talk.

First let me make a comment about ICSI.  there have been some recent articles about the safety of ICSI, but I think I would emphasize that there are also studies that suggest or don't suggest, that show that the health of the vast majority of ICSI children, who may be several years old now, is equivalent to that of other children.

And here I would emphasize again scientifically the issue that the easy way to look at outcomes is to compare ICSI babies or ART babies, IVF babies to the general population, and that may not be the best group to compare because there may be underlying problems that infertile individuals have that may be associated with their infertility that manifest themselves in ill health or disease in their offspring.

So although SART and ASRM are concerned about the safety of ICSI and believe very strongly that it needs to be examined carefully, the evidence that we have seen indicates that the vast majority of those children are healthy.

As far as the issue of conflicts between parents and the potential child, I think I'm going to pass on the discussion of the potential child.  Maybe Dr. Smith could.

DR. SMITH:  Well, I'm not going to talk about that, but I do just want to make two remarks.  First, I think it is obvious we have to distinguish rights from desires.  I mean, we can't assume that everything people desire they desire it with their whole heart.  For very good reason is, therefore, a right.

And at the end of the day, I come down on the side that says that having one's own biological child is not a right.

On the other hand, I have to say that I'm very uncomfortable with that because parenting was for me and has been for two of my three children a life transforming experience, and in my case, I'm lucky that it has been biological parenting.

So that it's a difficult one, and the possibility of adoption — actually I think Mary had some of this just exactly right — the possibility of adoption is a very relevant fact.

CHAIRMAN KASS:  Please.

DR. BRZYSKI:  I'm sorry.  I wanted to get to the initial issue that you raised about the conflicts between the parents and the potential child, and I guess I would go back to the concern I have about discrimination.

For instance, we know that there's a certain risk of transmission of HIV to offspring when HIV infected parents conceive, and I guess I'm concerned about having a different level or a different category of regulation or intervention for a couple that is able to conceive naturally, spontaneously in that regard versus a couple seeking medical care for other conditions where they happen to be HIV positive, and there's a judgment that has to be made there about is participation in health care delivery contributing or compromising the health of the child versus not meeting the needs of the patients there, the actual patients that are in front of you versus the potential patient that you might create.

And I think that's an issue that's been raised in discussions with the ASRM Ethics Committee, that it's difficult to isolate, segregate infertile couples and to somehow modify, you know, what to do to them versus what we allow us to do to individuals who aren't patients.

CHAIRMAN KASS:  Please, Mary.

PROF. MAHOWALD:  I guess Gil was right that that descriptive claim wouldn't be the one that I myself would make prescriptive, and as a matter of fact, I agree with David and would avoid the language of rights in my own arguments along this.

A word that I feel comfortable with for any parent by any means is that having a child is a privilege, and it ought to be viewed as such by anyone who becomes or hopes to become a parent.

But your question, Rebecca, really does nonetheless go to this notion of a right, and if there is any right to have a child, there surely is a right to have an unhealthy one.

PROF. DRESSER:  I guess I would wonder if there's a difference though.  Certainly if someone is a carrier of a genetic disease, the idea that we would somehow as a society say you're not allowed to reproduce is offensive to just about everyone.

But once the medical profession is involved and sometimes insurance and social resources and so forth, I think there are questions of responsibility and what is appropriate for the profession and the society to help.

I mean this is assisted reproduction.  So I guess I'm trying to get at your ideas about and back to this question of when prospective parents may prefer something that is perhaps not in the best interests of a future child.

MS. MADSEN:  This whole notion of children being a gift, life is a gift; we use this language an awful lot.  Good health is a gift, but when we do not have good health, we don't say, "Gee, I didn't get the gift.  I'm going to sit here and be really sick because I didn't get the gift.  I'm not going to see a doctor because, you know, God didn't give me the gift of good health."

So I didn't get the gift of fertility, but I was able to have the gift of a doctor who was able to help me have this wonderful basic human life activity, that I was able now to engage in and give birth to a child who at 14 understands that he's an IVF child, and who thanked me for the gift of being here and being a part of the family and couldn't wait to have his picture taken with Professor Edwards who had the first IVF child.  He was an embryologist.

He said, "I want to stand next to this man and have my picture taken because without him I wouldn't be here."

So there's lots of gifts, and I think that we should just be really clear about that.

And my children who are older now, 10 and 14, they didn't get to vote that they were conceived.  It's true, but neither did I.  They're really happy to be here.

CHAIRMAN KASS:  I have Robby George, Bill May, Frank, and then we'll probably stop.

PROF. GEORGE:  Thank you, Leon.

I was going to follow up a little bit on the very interesting line of questioning that Gil opened and Leon then very helpfully advanced, and I wanted to take it a little bit further and raise a different fundamental question, I think, that flows from it.

I take it that at least in the case of Ms. Madsen and Dr. Brzyski, the position is that ART is an area that's appropriate for government funding to support research and to advance the science in the area in order to make this technology more widely available and better.

Am I right about that?

MS. MADSEN:  Yes.

PROF. GEORGE:  Now, the point was made by a couple of members of the panel that we live in a morally pluralistic society, and in this particular area we're touching very intimate and inherently private choices.

Is that also something you agree with?

These are areas in which people hold very different moral views and the moral views of different people ought to be respected.

Everybody seems to agree with that.

But then, if we're talking about an area that is fundamentally private and intimate, it's not like a public function, provision of a police force or national defense, where people might have moral objections to it, but we've always held as a society that people's moral objections to it notwithstanding, we're going to carry out this public function and even tax people to pay for it.

But if you take the position that everyone's moral views ought to be respected, that people have different moral views about ART, you want your views to be respected; you're saying their views should be respected, and this is an inherently private area, not like the military or provision of police forces, what justification can you offer for compelling using the course of the power of the state to tax people who don't share your view on ART to contribute, to implicate themselves in fundamentally private behavior?

MS. MADSEN:  This is health care, and we're not talking about anything other than health care here, and you do not have to seek treatment.  No one is telling a couple that they have to seek treatment.  That's a private decision with the couple, and that's the same in any other disease group.

Patients make private decisions, whether it's breast cancer or prostate cancer or infertility.  In this country we provide health care for these kinds of treatments, and whether or not you participate in that is your right.

I'm not going to ever tell a couple what they should do.  I will tell a couple what options are available for them.

PROF. GEORGE:  But the reason I think that response doesn't get you off the hook of the question is that to treat the creation of embryos to solve infertility problems as health care is already to make a controversial moral judgment.

Certainly, the infertility is a health care issue, but whether we're dealing with medicine strictly speaking in the creation of embryos, and certainly you yourself concede that the question of the morality of creating embryos by this method or dealing with fertility by this method is more fundamentally controversial than whether to treat breast cancer, whether to treat kidney failure.

MS. MADSEN:  I actually didn't say it was more fundamentally controversial.  I don't believe that it —

PROF. GEORGE:  So you believe that it's not controversial, that ART is not morally controversial?

PROF. SANDEL:  The issue, Robby, isn't whether it's controversial.  The issue is whether you can provide a compelling reason publicly by ART is so morally objectionable that it shouldn't be included in health care.

PROF. GEORGE:  Oh, sure.

PROF. SANDEL:  So the burden is on you.  It's not on her to say whether it's controversial or not.

PROF. GEORGE:  Oh, no, no, not at all, Michael.  I'm afraid the burden is on you or on her because we know as a matter of fact on the ground that it's morally controversial, that people have different moral views.

The premise for the argument for privacy here is that where we have different competing moral views, those moral views ought to be respected and nobody ought to be imposed upon.

PROF. SANDEL:  But if the controversy isn't based on an objection that's well founded, we shouldn't take any notice of it.  So you —

PROF. GEORGE:  So people who believe other people's moral views are not well founded can simply disrespect those views.  So the principle that we ought to respect diverse moral views only depends on an assumption that the other person's moral views are morally defensible; is that right?  Is that your view?

CHAIRMAN KASS:  Gentlemen.

PROF. SANDEL:  No.  You can be a conscientious objector to the tax if you can show you've got a good reason to subtract it.

CHAIRMAN KASS:  Without settling the dispute between these gentlemen, and I'll even resist an opportunity to advance the ball on the discussion, let me call on Bill May.

DR. MAY:  I would like to address a question to you, David Smith, on the whole question of regulation and discretion and building up case by case something that you say resembles the common law tradition.

On the subject of embryos, you say, "Under these circumstances I think we will be best served by a flexible and case-by-case regulatory system with teeth."

Apparently a flexible system also can have teeth.  That's interesting because that's not the way that that term is usually used, but it is interesting that you do put them together.

DR. SMITH:  Well, I grade papers.

DR. MAY:  Yeah.

(Laughter.)

DR. MAY:  "We should be regulating all uses of embryos whether in the public or private sector, but our regulatory process should be modeled on common law, on incremental and something like case-by-case decision making within a very few, broad parameters."

Now, I guess I wonder who is the decision maker, the courts or professionals and potential patients.  Is the law simply permissive, turning over such decisions in the setting of which some kind of quasi-common law tradition would develop within a profession maybe or are the parameters really regulative?

You haven't seen a document that we will be discussing later, but there's a sentence I noticed.  "Most governmental authorities simply lack the expertise to provide meaningful oversight of professional activity, and medicine is a profession where crucial judgments must be made on a case-by-case basis by a practitioner familiar with the details and circumstances involved.  The law tends to give physicians ample latitude to make such judgments."

So when you're talking about parameters and so forth, are you talking about parameters with some kind of content and then within which professionals operate and make the decisions or within the setting of which one further elaborates case by case the common law tradition in which case the courts are making decisions?

DR. SMITH:  (a)  I think these are very good questions. 

(b)  I think my instinct is to say that just — that's the first thing.  Secondly, my instinct is, in fact, to trust professional discretion, but I was not encouraged by the report that we heard a few minutes ago about the Fertility Society's community's history of self-regulation.

I do strongly sense — I really think that circumstances alter cases, and I want people on the ground making those decisions as much as possible, but if, in fact, there's a history of loss of teeth, of de facto no regulation and entirely permissive practice, then something else has to be set up.

I don't know if the IRB system in which you've got a combination of professionals and nonprofessionals serves as a useful model.  I do know one example that isn't good for my point.  When the U.K. altered its abortion law in the '60s, they opted for a regulatory system that was essentially local or, in the case of less populated areas, regional boards that would decide on a somewhat case-by-case basis if the stakes in individual cases were high enough to justify abortion, and I thought that made great sense.

De facto, however, it failed or it has failed because what it evolved to is total permission or evolved, in effect, to no regulation.

I still haven't given up on the idea, and I think this is an area where sweeping prohibitions or just blanket permission strike me as wrong.

I don't know.  That's not a very good answer.

CHAIRMAN KASS:  Frank Fukuyama.

PROF. FUKUYAMA:  Well, it turns out this question actually follows  on the last one, but it's actually directed to Kathy Hudson.

I agree with you, Kathy, completely that, you know, one of the basic principles ought to be participation by, you know, a fairly broad community, and I wonder whether you have given any thought to, and I'm very glad that you're doing these polls and focus groups.

Have you given any thought to how you institutionalize participation as you go down the road in the future?

You know, in a constitutional democracy, the basic guarantee of participation is elections, and you know, you elect people to Congress, and you can lobby them, and so forth.   When you get into biomedical regulation because it is so technical, democracies then tend to delegate regulatory authority through an epistemic community that has the knowledge and specialization, you know, to deal with that set of issues, which then tends to insulate, you know, that group from broader public participation.

Congress can always intervene, but you  know, it is not encouraged and so forth.

Now, do you think that the current situation where as we go down the road to these kinds of more controversial technologies like PGD and, you know, some day germline and other things, the current system where that delegation to the professional community with occasional focus groups and polling and the existing, you know, comment and, you know, posting regulations and opening them up for public comment; is that going to be adequate or do we need something else to get on an ongoing basis the views of a broader public other than, you know, the people that are professionally engaged in the practice of biomedicine?

DR. HUDSON:  I'm not sure I'm going to be able to satisfactorily answer the question because I don't know how this is all going to turn out.  I think there is an appropriate role for the public's voice or some representative sample of the public to provide their reflected opinion, not just their knee-jerk reactions.

That can provide sort of the framework, the bounds within which the professionals can then say in order to achieve that vision of the way we want the world to be, in order to uphold those goods and reflect those values, you know, we know what our course is, and now we'll do the tinkering to construct the regulatory framework that can best achieve that.  Looking in our policy toolbox, what tools can we apply to do that, to accomplish that?

I think that there can then be a disconnect because you are speaking different languages at some point.  Whether or not that process of public participation can be institutionalized I'm not sure exactly how to do that.

Engaging the public beyond just asking them five questions in a telephone survey is a very difficult and very expensive undertaking.  So in some ways it's a privilege for us to be able to have the opportunity to do this.

CHAIRMAN KASS:  The last question to Mary Ann Glendon, and then I'll have a comment and we'll break.

PROF. GLENDON:  I'd really like to know something about the kind of conversation that you have with a woman who's considering IVF.  I assume that your organization has guidelines for clinics about what subjects should be brought up, and I'm wondering in particular about two things. 

One is whether in any more than a cursory way the subject of adoption is brought up, the exploration of alternatives.

And, secondly, whether in addition to discussing the known risks of the procedure for the woman, there is any discussion of the potential long term health consequences.  It's a relatively new procedure, and you know, we found out some unpleasant things about diethylstilbestrol used to prevent miscarriages back in the 1950s.

Is there a conversation about those long-term risks incorporated into this preliminary counseling?

DR. BRZYSKI:  Well, I would say that the principles of informed consent, regardless of the therapeutic intervention that's proposed, incorporates a discussion always of alternatives and risks.

Specifically in the case of assisted reproduction, whether the discussion of adoption is more than cursory or not I think would be hard to say.  Most patients who come to the decision to do IVF, it's a process that they go through.  So it's not something — like a typical patient I see will come.  They're infertile.  They don't know why they can't have children.  They go through a diagnostic process.  We try some therapeutic interventions perhaps, and over the course of time, maybe even at the first consultation we'll say, "Well, I'll take fertility drugs, but I'd never do IVF, you know."

And then three years later as they've learned more about their condition, about their options for treatments, the expiration of the possibility of adoption, which practically all patients discuss with me over the course of that time, there's a consensus among the physician and the patient to pursue the IVF therapy.

So it's not like you just sit down and say, "Okay.  Now we're going to talk about this consent form," because practically it's a process that stretches over a long period of time.

But during that time the issue of long-term risk has certainly been brought to our attention or concerns about that has been brought to our attention, and again, practically the example of whether fertility drugs cause ovarian cancer is sort of open the door to that line of discussion with patients, you know.

Whether or not that's true or not, it provides an example to patients that they can understand regarding other possible risks to their children and to themselves.

So I would say that professionals are used to discussing and are comfortable discussing with patients.

CHAIRMAN KASS:  Thank you very much.

Let me make a request.  First, thank all five of you very much for being here, for clear presentations, for very thoughtful and forthcoming responses.

I would like to take the liberty of being able to write to you, have the council staff write to you to follow up on some kinds of questions that have emerged here.

In particular, I would flag the question that Rebecca Dresser asked.  To what extent is the child to be, in fact, regarded as a patient in this process?

And also more thought on the meaning of the fusion of assisted reproduction with the coming genomic knowledge.  We barely touched on that, and whether or not — this is for you, especially, Kathy — whether there are lessons that we might have learned as a result of genetic testing in the adult context that ought to prepare us for the kinds of questions to worry about here, as this is now coming here.

On that subject, by the way, let me call council members' attention to a paper by a person who couldn't be here to present today, Tonya Simoncelli, who has a paper that you have seen a presentation on PGD, regarded in her view as sort of the gate opening or the wedge technology toward a new kind of eugenic future and those kinds of concerns haven't yet really been discussed here, but the council members should notice that.

We'll take a break.  Let's make it ten minutes this time.  Our guests are waiting, and we don't want to keep them too long.  Ten minutes we'll reconvene.

Thank you all.

(Whereupon, the proceedings went off the record at 3:39 p.m. and resumed at 3:56 p.m.)





  - The President's Council on Bioethics -  
 
Home Site Map Disclaimers Privacy Notice Accessibility NBAC HHS