THURSDAY, June 12, 2003
Session 3: Biotechnology and Public
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
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
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?
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
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
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
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,
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
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
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
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
And once again, the infertile have no wish to be roped into that
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
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
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
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
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
If the right to have a biologically related child is fundamental,
then justice demands that infertility treatment not be withheld
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
CHAIRMAN KASS: Thank you very much.
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
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
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
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
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
CHAIRMAN KASS: Thank you very much.
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
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
Second, I'd like to point out that public participation must
be a core principle that guides policy development, process, and
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
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
Thank you for your attention.
CHAIRMAN KASS: Thank you very much.
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
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
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
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
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
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
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
PROF. SANDEL: Well, that addresses a different
MS. MADSEN: And they're separate. And they're
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
PROF. MAHOWALD: No.
PROF. SANDEL: You would agree.
PROF. MAHOWALD: Yes.
PROF. SANDEL: But those are two separate issues,
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
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.
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
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
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
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
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.
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
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
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
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.
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
(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
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
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
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
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.)