Friday, March 7, 2003
Session 6: Biotechnology and Public Policy:
George J. Annas, J.D., M.P.H.,
Edward R. Utley Professor & Chair,
Department of Health Law, Bioethics & Human Rights,
Boston University School of Public Health, and
Professor, Boston University School of Medicine and School
CHAIRMAN KASS: I'd like to get started
and in ten seconds call on George Annas for his response,
and afterwards we'll consider the two presentations together,
and people who were still in the queue for comment before,
I still have your names and you will not be forgotten.
I did want to mention to everyone present that the council's
Web site has been redesigned since the last meeting, and I'd
like to call your attention especially to a feature of which
we are particularly proud: selection of readings from our
bookshelf, supervised by Rachel Wildavsky, which now has three
sets of readings up there in the spirit of "Toward a
Richer Bioethics," in addition of the one on "Among
the Generations." We have something on scientific aspirations,
and something on the pursuit of perfection. There are things
coming along on vulnerability and things on "Many Stages,
One Life." So please keep your eye open for what's coming
George Annas, thank you very much for joining us. The floor
MR. ANNAS: Thank you, Mr. Chairman.
I don't look at this so much as a response as another view,
let's say, of self-regulation.
CHAIRMAN KASS: Please.
MR. ANNAS: All right. I'm a regulator,
and I'm very comfortable regulating things. I've spent my
life with physicians. So I'm comfortable trying to regulate
physicians, as well.
I do believe most of them need regulation, and often they
are very happy to be involved in it, but, on the other hand,
as we know from the current debate on medical malpractice,
they're not particularly fond of physicians or with lawyers
— I'm sorry — and not particularly fond of private lawsuits.
So when you look at the area of how to regulate any industry
or activity, you have choices of the market, the market in
private lawsuits, professional self-regulation if you're a
professional, or some form of government regulation, or even
as I'm going to suggest at the end, a hybrid, government-private
type of regulation similar to that which we have in organ
donation and organ transplantation in the United States.
So first, just a bit of my own biases. I started my career
part time on the Board of Registration of Medicine in Massachusetts.
I spent six years on that board regulating physicians as its
vice chairman and chairman of its complaint committee and
enjoyed that quite a lot.
Then I was the chair of the Massachusetts Organ Transplant
Task Force whose job was to try to produce regulations to
introduce liver and heart transplantation into Massachusetts.
As many of you know, the most expensive and probably the —
they think they're the best as well. We all think they're
the best — medical system in the world, the most expensive
medical system in the world.
And we made it much more expensive by making sure not just
one hospital, but four hospitals did liver transplantation
in the first year it was introduced.
I am, as you've mentioned, Mr. Chairman, past member of
the ethics committee of ASRM and happy to take responsibility
for the many documents that came out while I was on the committee.
Rebecca has told you those were all consensus documents, and
in my years on the committee, our chairman was one of the
most distinguished people in the contemporary history of bioethics,
Dr. Ken Ryan, who died recently.
But Dr. Ryan was an unbelievable chairman. I mean, he was
as knowledgeable as you can be about the field and also knowledgeable
about regulation. He was, as many of you recall, the chairman
of the first national commission for the protection of subjects
of biomedical and behavioral research.
That commission met from 1973 to 1981, and its regulations
were essentially all but one adopted and put in the Federal
Register and form the basis of the current common rule for
all human experimentation that is governed by those regs.
in the United States.
And Dr. Ryan ran a terrific committee, and I think the deliberations
of that committee speak for themselves.
And there are some problems with self-regulation that the
committee, which is, I think, as good as you can do, by the
way; I'm not going to critique any members of the committee
or any of the motivation of having such a committee, but I'm
going to critique the reality of how you put a committee like
that into existence and what happens to its rules.
There are a number of critiques of professional self-regulation
that I'm sure you're familiar with. The most recent one is
by medical historian David Rothman. He wrote a very powerful
op-ed piece in the New England Journal of Medicine two years
ago called "Medical Professionalism, Focusing on the
And Professor Rothman argued actually that medical professionalism
had to be invented. It couldn't be restored; that there really
never was a time — maybe it's a little harsh, but this is
David talking, and I'm sure he would defend it — there never
really was a time when physicians could be said not to have
bad interest in themselves first.
And, of course, you'd say that's true of everybody in society.
When they weren't more interested in their income, their control,
their autonomy, and what they could do in terms of practicing
medicine without outside interference, and I certainly saw
that on the Board of Registration in medicine.
Our Medical Society in Massachusetts, like all the other
medical societies around the world, was not very happy about
being regulated. And if they were going to be regulated, they
wanted a majority. Well, we had five out of seven of our members
were physicians. They wanted physicians doing the regulation,
and in some sense I don't blame them.
But as David Rothman argues in this piece, in order to do
that, you have to go beyond self-interest, and you have to
really do things that are in the interest of the public.
David gives six recommendations to invent professionalism.
I just want to mention the fifth one because it's specifically
relevant to what we're talking about today. He said, "Professional
organizations must be persuaded to expand the agenda for which
they lobby and advocate." And then he goes on and says
nearly all of these organizations advocate for themselves
for making sure that insurance or government programs cover
whatever it is they do, and as he calls it, the special interest
of organizations' members.
And then he suggests something which he says he's gotten
more hate mail than for anything he has ever written in his
life. He suggests that it's, you know, de riguer for the dermatologist
to say we should cover more dermatology services, ophthalmologists
say we should cover cataract surgery, et cetera, and for our
gastroenterologists to say we should cover colorectal cancer
treatment therapy or screening. I'm sorry.
Imagine, he says, what could have happened if these societies
had advocated for the well-being of patients without regard
for their own self-interest. Support by dermatologists and
ophthalmologists for colorectal cancer screening, he said,
would carry great weight in the debate over whether to include
it as a benefit. Again, he says the barriers to such activities
are formidable, and he obviously thinks how the public might
respond to advocacy that was driven not by narrow self-interest,
but by broader professional vision of patients' welfare.
Now, of course, the hate mail he got was from gastroenterologists.
So he went to what in the hell do dermatologists know about
colorectal screening and, you know, quite properly so. But
the issue is not a technical issue. The issue is what are
your goals; whose interest do you care about; and how do you
further those interests.
And the notion that professionals, if they're to be professionals
have an obligation to go beyond this self-interest that non-professionals
go to. That's essentially a trivial — well, not a trivial
point. he makes it very well. It's actually a critical issue.
It's can professional committees, can professional self-regulation
go beyond the interests of the members and look to protect
patient welfare in general.
In my experience on the ASRM ethics committee, it's certainly
possible but very difficult. The ethics committee couldn't
do it itself, as Rebecca has pointed out. The Executive Committee
gets to approve anything that the Ethics Committee points
out, and then after that, what enforcement there is if anyone
knows about them is often up in the air.
Nonetheless, t he fundamental question is what's the charge
of an ethics committee. What's the charge of having rules
for your members, and I spent six years on this committee,
as I say. I take full responsibility for everything I did.
On year three, which I think was around 1995, when we had
on the agenda things like post menopausal pregnancies, using
fetal ova to try to create a pregnancy. On the committee that's
one of the few thins the committee said should never be done,
which is great, and disposition of embryos, et cetera. All
of these issues were on our committee.
And before that committee or just as that committee meeting
started, I asked the chairman if I could summarize what I
thought the committee's operating assumptions were, and here's
what I said, and I thought this was an insightful critique.
I said: here's our operating assumptions.
Number one, the ethical acceptability of new reproductive
technologies is to be assumed, and the burden of proof is
on anyone who would question a new technology to show how
its use is unethical.
Number two, the use of a new technology cannot be declared
unethical if there are any possible ethical applications of
that technology no matter how hypothetical.
Number three, it is assumed that imagined new technologies
will ultimately work and will prove beneficial, and that any
imagined harm from the technology expected can be controlled
unless proven otherwise.
And number four, the major values to be taken into account
in evaluating new reproductive technologies are economic—
efficiency, supply and cost— and not ethical.
Now, I thought this was a critique, and so I was a little
surprised when Chairman Ryan turned to me and said, "George,
well, of course that's exactly right. That is how we operate
and are operating. That is our operating assumptions,"
and indeed, they were.
And in one sense, you know, you'd say, well, gee, you know,
you should have different operating assumptions, and I think
we should, but on the other hand, another way to say that
is we believe in what we're doing, and the burden of proof
should be on other people to prove to us that there is some
harm or some other aspect that comes into this.
Well, let me suggest a couple of other operating assumptions
that we could have instead of these. Actually Dr. Carson suggested
some, which I like a lot. She suggested safety efficacy and
privacy. That would actually be better than the ones we worked
on, and even better yet, healthy children, healthy parents,
and healthy third parties.
That's terrific. That was not in existence when I was there.
In fact, I argued at a meeting of this society in Toronto
not as a member of the committee, but as a person giving a
speech there that the organization should take a firm position
that their number one concern was children.
That to my knowledge hasn't happened, but nonetheless the
language "healthy children" is a big change from
my perspective at least.
And the second thing that I think is necessary and have
argued for that is for the group to think more like physicians.
Now, what do I mean by that?
Well, even though actually your Chairman and I have argued
about the Hippocratic Oath in a prior life here, in terms
of the Hippocratic principle, first do no harm, that makes
perfect sense to me in terms of doing reproductive technologies,
and do no harm to children strikes me as the right principle
to use as a starting point.
And then the second principle is to always take the welfare
of your patients as the first priority.
Now, if we started with those assumptions instead of the
operating assumption of the current chairman of the committee,
which is procreative liberty, and John Robertson is an old
friend of mine. We go back 30 years, and we've been debating
our whole lives and we'll never agree with each other, and
I'm not trying to score cheap points against John. Procreative
liberty is very important, but it's not the only value. It's
not the only value in society, and it's not one that can determine
everything that happens because you start with procreative
liberty. You take as an assumption that people can do whatever
they understand with informed consent that they agree to,
and that the only thing that could possibly stand in the way
is if someone could prove that there were significant harms
to a child that would not have been born but for the procedure.
Sine it is never possible to prove the second thing, you
wind up that you can always do — that the rule is, and this
is the operating ethical rule of physicians in general, not
just our own physicians, that as long as I want to do it,
it's accepted medical practice and my patient gives informed
consent, leave me alone.
And that's basic medicine today, and mostly not just here,
but mostly all right, and that's why most regulation in medicine
is done by private lawsuits and malpractice and why we have
even with the Institute of Medicine and four years afterwards
talking about 100,000 deaths a year caused by physicians.
We have really no movement in the patient safety movement,
no real desire by physicians to try to clean up their act
in general, and an almost impossible situation where it is
seen that the only say we can move forward is to protect physicians
against liability and keep errors secret, even though all
of the surveys show that patients want to know immediately
if doctors have harmed them due to errors.
The other models that are used in the new reproductive technologies,
and I have the one handout that I did give you in your materials,
pretty much a summary of my views of the field from my 25
years as an outsider, are that it got started off on the wrong
foot, and my friend a colleague, Dr. Sherman Elias, a geneticist-obstetrician,
and I wrote a piece in JAMA in 1986 on this, that, again,
your Chairman was kind enough to review and give us some really
good suggestions on.
Then I got started using the artificial insemination by
donor model, and that was a big mistake, and we still use
that as you heard even in valuing how much a woman's egg is
worth. We try to figure out how much a sperm donor's time
using sperm is worth, but the sperm donor model was a mistake
because historically the first thing doctors did after they
used donor sperm was literally to destroy the records.
They don't do that anymore, but the idea was that you had
to protect the best interest of the sperm donor, even at the
expense of the best interests of the child. So if the child
wanted to find out later who his or her genetic father was,
it was not possible. That's been more or less changed now.
Actually adequate record keeping is required, but it's still
extraordinarily difficult for children of AID to find out
the identity of their genetic father.
That's a bad model. I mean the last thing you want in medicine
is secrecy, it seems to me. You do want confidentiality, but
you certainly don't want secrecy from the people involved.
You may want it from society in general, but we've used that
model not only to figure out how records should be kept, what
kind of confidentiality and privacy there should be, but also
to move over into a place where I think and have argued unsuccessfully
it has no place at all, which is an ovum donation, which is
nothing like sperm donation at all. As you've heard, it's
a medical procedure with major risks. There's sharp limit
of the number of ovum women can donate, and there can be,
you know, significant problems to this.
To equate it with sperm donation makes no sense, but nonetheless
we say we want gender equality and so we have to do that.
A number of people have mentioned it, even though we want
to talk about individual things, this statement at Tab 19
on financial incentives to ovum donors, and I think I was
off the committee when it actually came out, but I was certainly
honored when it was developed. So it's another one I have
to take responsibility for.
But one of the things in there which I thought was critical
and the committee was willing to put it in is that every ovum
donor should have their own physician. Okay? And what I meant
by that and what the committee meant by that is not a physician,
you know, who is involved in the IVF procedure, is already
committed to the couple or committed to make sure that eggs
are gotten for these particular patients, but is committed
to this person as a patient, to this woman who's undergoing
a significant procedure with significant risks.
And that's because I believe in two things, which is not
shared by a lot of people in the field. Number one, that there
should be no purchase and sell of eggs; that that's a problem;
that that commercialization of eggs is a problem, and it's
a subterfuge to call this just giving money for inconvenience.
And, number two, that any physician who's worthy of the
name would not subject his patient to a risky procedure just
for the sake of being paid for their inconvenience. It can't
be done. It can't be justified.
It can barely be justified in kidney donation, live kidney
donation. Even that's problematic, but at least there you
have someone with a terminal illness whose only option is
to undergo dialysis, and it can barely be justified there.
But even there we will not pay that person to donate their
kidney. That's a much more vigorous, heroic thing the person
does under those circumstances.
So in any event, I think it's problematic. The role of physicians
is problematic, and if you're going to be a physician and
deal with things like egg donation, you have to, it seems
to me, put the best interest of your patient first, do no
harm first, and there are some things that you just have to
say we can't do.
Yesterday's Wall Street Journal, some of you may have read
this. A movement or not a movement, but a trend around the
country and certainly in Europe and Australia to do away with
the drugs, the hyperstimulation drugs, and then you can only
retrieve one egg a cycle and obviously it cuts down on your
ability to do that, but it's much, much, much better for the
women involved in terms of risk, and it turns out to be much
cheaper, too, although long term studies haven't done — will
have to say how successful it is to see in the long run and
how much less expensive it is.
But the point is there are alternatives that don't put healthy
women at risk for money.
The second problem, and I'll just go through this quickly,
is a problem of private contract. Because the entire system
is seen as private, personal, and secret, the notion is that
instead of having rules that apply to everybody, we should
be able to contract and define our own rules.
The New York Task Force on Assisted Reproductive Technology
and virtually every task force that's looked at this, public
group that's looked at this has said, for example, that they
believe that the proper rule should be the rule, and it actually
is a rule in at least 48 states of this country, maybe 49,
that the woman who gives birth to the child should be considered
the child's legal mother for all purposes.
That's not the rule in California, and the rule in California
is that the legal mother is the, quote, intended mother. And
who is the intended mother? It's whatever the couple, the
surrogate or whoever is involved in this decide by contract
beforehand who will be the mother.
That to me, as I wrote in this article that you have makes
no sense. I think whatever rule we have we have to be able
to identify the mother at the time of birth, and she has to
be there with the rights and responsibilities for the child,
and the only woman who is going to be there at birth is the
birth mother obviously, and she's the woman we've always considered
the mother, and it seems to me that for the child's sake and
her own, that presumption should continue and no private contract
should be able to change that.
Nonetheless, this is not just ASRM talking. This is California
Supreme Court thinks that that's okay, and again, the California
Supreme Court did this on the basis of sperm donation, and
they said, "Look. If we can figure out who the father
is by contract and keep the name and identity of the sperm
donor secret, we should be able to figure out who the mother
is by contract as well.
And, again, I think that that analogy does not hold, that
the court is wrong about that, but nonetheless that explains
why most surrogate mother contracts are done in California,
and it also helps explain a tremendous cultural shift between
the days of Mary Beth Whitehead when we had pictures and lawsuits
and people wondering what was going on, and today when you
look on the newsstand today People Magazine, something I read
every week. No, but you should read this if you're involved
in this. This is a celebration of surrogate motherhood and
donor egg when Joan London has hired a surrogate and gotten
eggs from someone else to have twins for her and her husband
in her second marriage.
I'm not saying there's anything wrong with that, but I'm
saying she shouldn't be able to make up who's going to be
the mother and who's going to be the father; that we should
know who the mother and the father is for the sake of the
children, regardless of whether the surrogate is from Ohio,
as she is here, or the contract was made in California or
that there was some other arrangement. That shouldn't be a
matter of private contract.
So those are my primary problems with the current regime.
Nonetheless, let me say I think ASRM — and I actually do
believe this — has done just about as well as you can do
in terms of private self-regulation. It is actually a model.
If you go around and look at some of the others, with the
exception, I think, of pediatrics, but I think pediatrics
is an exception because their patients can't give consent,
and they know they have extra obligations to the children
patients they have.
And you can't have a contract informed consent model with
a child. So with the exception of the American Academy of
Pediatrics, all of whose statements are child centers and
all of whose statements begin with the best interests of the
child is paramount, and almost every other medical specialty
has the basic rule that if the doctor and the patient agree
to it, it should be permissible using informed consent documents.
Okay. Those are kind of easy questions, you know, because
it's easy to say what problems exist and what can be done
around the edges. The much harder question, and I'll just
throw out a few minutes of this and then we can discuss it,
is if you wanted to regulate, number one, is it possible.
Could the public actually get involved in this?
And, two, what are the models that exist that could be pursued?
Before you start regulating, before you even think about
regulating, obviously the first question you've got to ask
is why. What's the problem that you're trying to address because
it is very, very, very possible to create more problems than
you solve, to be totally counterproductive in doing regulation,
just as it's possible to create more problems than you solve
doing ethical statements.
By the way, I may have misunderstood this statement that
you made, Sandy. If I did, I'm sorry, but it doesn't really
matter because the point is that these statements require
interpretation. The disposition of abandoned embryos, which
I've signed off on and helped writing, and I certainly agree
it makes perfect sense to me and we shouldn't keep embryos
frozen forever, and that after some period of time when you
lose contact with the gamete donors, that you should be able
to destroy those embryos, and that the position taken here
was five years destroy the embryos. I think that's fine.
We also tried to make it clear, but obviously did not as
I read this again that you should not be able to use those
embryos for research or to donate to another couple without
explicit consent, but I could see how you could reread this
and say that the new regulations on embryos for stem cells,
which require contemporaneous consent, as I believe all research
should, only apply to stem cell research and that this document
gives you the right to use these embryos for research for
For me that would be a misreading of this document. That's
not right? Okay, good. I'm glad I misunderstood that.
All right. But the other point is somebody has to read and
interpret these, and I could see how someone could read and
interpret it that way and say if someone said to them, "Well,
you're violating the regulations," they'd say, "No,
you have a separate regulation for that. This one is for this."
And if you read them together, as lawyers do all the time,
you could interpret it that way.
Okay. So the first question, as to the activities is a very
important question, is if you wanted to regulate, do you want
to regulate human experimentation and research or do you want
to regulate ART, assisted reproductive technologies?
My own bias, and it may mean nothing to you, is that we
should have a federal regulatory scheme for cutting edge research.
That should include artificial hearts, xenografts, embryo
research, research of the kind that local IRBs — it is simply
beyond their competence, not that they don't try hard, and
recently we have added to that smallpox vaccine on children,
which went to the federal government anyway, and we weren't
able to come up with any agreement except not to do it.
But big time, risky, new types of human experimentations
seem to me to require a type of regulation that we don't have,
and some of the things that are done in ART, especially around
embryos, cloning, stem cells, would fall into that rubric
So if you wanted to do that, that would be one kind of a
regulatory scheme. There would be no problems with federal
authority to do that, and it would fall into the same pattern
of the proposals by NBAC to cover all human research, not
just federally funded research, but private research as well.
The second type of research — so that was one way — the
second way to go is to regulate ART. That's much, much harder,
but possible because if you do that, you have to break it
out in terms of federal regulation and state regulation.
The issues that I'm actually most concerned about: who's
the mother? Who's the father? How do we insure the welfare
of the children? How do we make sure the child has access
to their record, et cetera, to their genetic information?
Those actually turned to all be issues, family law issues
which would be the province of the state. So to do that we'd
have to go — we could still write a model situation, but
we have to go state by state, and that is not going to change.
The Supreme Court is not going to change that, nor do I think
should they. Family law issues rightly belong at the state
So you couldn't do that on a federal level. The federal
level, on the other hand, you could regulate the commercial
aspects of assisted reproductive technology, not just the,
frankly, commercial aspects like advertising and pricing,
outlaw the purchase and sale of gametes, if you wanted to
do that, which I do; outlaw the purchase and sale of embryos
But I think you can also regulate some of the practice,
a lot of the practice, the record keeping requirements, the
screening requirements, contract requirements, informed consent
requirements, and counseling requirements, and you could have
uniform rules for everyone, that unlike the ethical rules
could be enforced. You could set up a licensing scheme. You
don't have to, but you could follow the British model and
license ART clinics.
I actually didn't realize there were 25 that weren't even
members of ASRM. It should be unacceptable. I mean, they should
all be operated under the same set of rules, it seems to me,
that we should have national standards for this, and you know,
that would be something that a separate agency could do.
Now, historically in other countries that have done this,
I know you heard from Patricia Baird. You've heard from the
regulators in England as well. It has taken a big time federal
national commission to study this issue for years to come
up with recommendations which are then adopted by the parliament
or congress or whatever their legislative group is.
It would take the same in the United States. I don't think
you could just go to Congress.
Could this group do it? If that's what you wanted to do,
I think it's possible. You could, but you probably couldn't
do anything else. I mean, it's a giant undertaking. It would
require input from many, many people. Lots of input from ASRM,
I'll leave it to you whether you want to pursue that or
not, but there are models out there.
The final model and one that I actually think might satisfy
both sides, both sides being the public and the profession,
is an UNOS model, United Network for Organ Sharing model,
which was followed for like almost 20 years in this country.
Can we regulate organ transplantation? Isn't that something
that we should let private physicians and people do?
And of course, the reason we decided we needed some public
input from that is because organs came to be seen as, a very
weird word, a natural resource according to our presidential
organ transplant task force back in 1986.
And the idea, of course, is that we get organs from everyone,
and it seems unfair that everyone shouldn't be, therefore,
eligible for organs, and it also does seem — maybe that's
obviously why we do have essentially a system of national
health insurance for livers, hearts, and kidney transplants
and for nothing else in this country.
But it also seemed that we needed a public transparent method
to see who got those organs because it was life or death decisions.
There was a shortage. There continues to be a shortage, and
the public trust was absolutely essential for this to go forward.
On the other hand, people are suspicious and rightfully
so. Too intrusive government regulation in the doctor-patient
So we wound up with the federal government, Congress, and
then regulations under HHS setting the standards for organ
transplantation and then having a private group contract it
out, the United Network for Organ Sharing, to implement those
And we can argue about how well that works overall I've
been a critic of that as well. Overall it works quite well.
I think it does work quite well, and that's a possible model
for you to consider as well.
So with that kind of personal critique of self-regulation,
self-personal experiences with ASRM and some suggestions of
where you could look for different regulatory models, let
me open for questions and comments.
CHAIRMAN KASS: Thank you very much for
a very responsive and direct and very interesting presentation.
I am somewhat at a loss as to whether we should first have
some comments directed to Professor Annas and whether the
people who are in queue would yield at least for a few minutes
to get some clarification, but I have you.
I have Robby George, Alfonso Gomez-Lobo, Frank Fukuyama,
Elizabeth and Bill Hurlbut.
You're taken care of already.
DR. GÓMEZ-LOBO: I yield.
CHAIRMAN KASS: Is there someone who would
like immediately to respond to — Rebecca Dresser and Michael.
PROF. DRESSER: George, I just wondered
if you would give us your thoughts on the problem of getting
both the state legislatures and Congress to act in this area
that is fraught with controversy.
MR. ANNAS: Well, as I say, I don't think
it's impossible. It's more likely to get action on the federal
level probably than on the state level right now, but it's
very, very difficult. I mean that would require like you'd
have — this group, for example, would have to say, "This
is our highest priority."
That might not do it even, but if you didn't do that, definitely
nothing would happen.
On the state level we've had a remarkable report, which
I commend to you. You've probably seen it, the report of the
New York State Task Force on Assisted Reproductive Technologies.
They recommended 80 different changes in their law.
To the best of my knowledge, none of them have actually
taken place yet. So that gives you some idea of how difficult
it is to pass legislation even with state group whose charge
was to recommend legislation coming up with an exceptionally
well articulated program with good reasons.
So this is a very, very difficult thing.
The second thing that happens, and I don't have to tell
this group that, is that this becomes very quickly entwined
with abortion politics, and you're going to have a lot of
people who obviously don't care about this issue, but who
for them, you know, physicians and assisted reproduction is
not an issue at all will be against any regulation of anything
having anything to do with pregnancy and childbirth because
they're afraid once you regulate that then you're going to
start, you know, cutting back on abortion rights.
And I actually have a lot of sympathy for that view, and
I certainly understand it. But it just makes a life of a regulator
much harder. so there's those two political realities.
CHAIRMAN KASS: Michael Sandel.
PROF. SANDEL: I found your critique of
the existing arrangements very persuasive and thorough. My
question is what would be wrong in your view with our adopting
the British system?
MR. ANNAS: Yeah, I mean, I don't think
actually — I'm quite fond of the British system. I don't
see anything wrong with adopting it. We're not Britain obviously,
but — and I recommended that. I commended that before, and
I think that we could go that route, you know, but then you
put an awful lot of authority in one group, and no one will
support that until they have a pretty good idea who's going
to be appointed to run that organization and how the members
are going to be chosen and are they really going to have,
you know, a say.
I mean that's really the critical thing in England. I mean,
they have a different system. Obviously they have a national
health service and everything is funded and they don't have
the problems. Dr. Carson rightly pointed out that if you want
to do all of these wonderful things, you have to pay for them,
including, you know, registries of children.
And so one of the questions, having done that, even though
it was one of the few things left out of the Clinton plan
for national health insurance, could you set up a system to
regulate this and fund the procedures and not fund everything
So I don't think we can just have the British system just,
you know, transplanted here without understanding the whole
British system, but it's a good model to look at, absolutely.
CHAIRMAN KASS: On the questions of — let
me just jump in with this business about your, I think, very
proper concern for the well-being of children, and several
of us were talking previously. To the extent to which one
looks really at infertility as a frustration of procreative
desire and support of reproductive liberty, the child tends
to be sort of forgotten or at least left to the side.
Could you comment on how well you think the current practices
of SART actually do safeguard the interests of the child to
And, two, would the implications of some of your comments
earlier suppose that, in fact, pediatricians are those whose
primary interest is to care for the children really ought
to be somehow central to the ethics committee and other practice
review committees of the society; that there should be some
kind of greater collaboration here if professional self-regulation
is, in fact, to address the interests of all concerned, children
MR. ANNAS: Children, I think, are primarily
considered the province of the parents to take care of, you
know, in this setting, and of course, I understand that because
that's what infertility treatment is for. It's to try to help
parents who can't otherwise have children have the children.
All right. And the challenge is how do you get children
more focused and their interests more involved here, and you
know, that is a challenge. I mean, obviously the pediatricians
take them right after they're born and they're no longer in
the care of these specialists, and they may have other obstetricians
even. They may not even be delivered by the infertility specialist.
So if you wanted to have a physician model of all this,
you'd have to have a joint ethics committee, if you will,
with the American Academy of Pediatrics, ACOG, the American
College of Obstetrics and Gynecology, and in fact, those two
groups do have a liaison and do meet together, and actually
there is some overlap historically with the ethics committee
of ASRM and ACOG, and since many members of ASRM, not all,
but lots, are obstetricians as well.
That's the kind of mix you have to get, but you have to
get more pediatricians involved. I think obstetricians have
And the interesting question, actually there are — you
know, my colleague, Michael Grodin who was the liaison member
of those two committees for six years reminded me before I
came here that one of the things they wrote was a position
on surrogate motherhood back in 1994, and they wrote it together,
and they wrote it based on the best interests of the child,
and his point was that the ultimate statement was very similar
to the ASRM statement. There really wasn't any difference,
even though they didn't come at it — they didn't mention
the child, but they didn't come at it from the best interests
of the child. They came at it: does this make sense for a
couple who is trying to have a baby?
Nonetheless, the bottom line from the two was lots of caution
and here's what we do, and it wasn't different. The people
coming at it just from the interests of the child did not
say we should ban it, but both groups came out at the same.
So you may not come out differently on a lot of these things,
but you will have other considerations in the mix when you
CHAIRMAN KASS: Thank you.
Oh, I'm sorry. Then unless there are other immediate respondents,
let's declare both presentations open for discussion and,
indeed, discussion of the issue as well as the presentations,
and I have Robby, George, and then Alfonso.
I've got starting with Robby, and then Frank and Elizabeth
and Bill and so on.
PROF. GEORGE: Thank you, Leon.
I do have two questions that I'd like to bring Professor
Annas and Dr. Carson into conversation on, and, Rebecca, I'd
be very pleased if you could chime in on both of these as
The first one has to do with the general problem of self-regulation.
My own impression is that there's a problem of self-regulation
which I do not oppose with any enterprise, and with everybody
who has a vested interest in an enterprise, and that is that
the enterprise and those with an interest in it have a stake
in the reputation and good name of the enterprise and protecting
that against embarrassments.
Now, the standard answer to that, whether we're talking
about medicine or any other field, think of the police, think
of religious institutions, is that, well, look. The long-term
interest of the enterprise really is served by good self-regulation
and by not covering things up because it all comes out in
the end anyway, and it's worse in the long run for everybody
concerned even looking at it from a selfish point of view
if we get it out.
But, again, looking at police and religious institutions
as examples, one finds that, well, often the view taken by
those with a vested interest is a relatively short-term view.
It's getting through the problem now. It's avoiding damage
to the reputation now and putting things off and the long
run will just have to take care of itself, and of course,
then in the long run, as was said, we're all dead.
So the standard answer doesn't always work so well. Now,
what some other institutions, including those I just mentioned,
have tried to do about that problem unfortunately too often
after significant embarrassments is bring in some sort of
external reviewing to the process of self-regulation.
So we're not now talking about government regulation as
an alternative to self-regulation, and there may of course
also be government regulation going on, but rather involving
in the self-regulation outsiders to the enterprise who have
an interest in at least some level of expertise, but who may
not be entirely tied in with it and may, therefore, have some
objectivity and distance.
Think of police review boards, for example. So I'm wondering
whether — this is my first question — I'm wondering whether
this is already a feature of the self-regulation of this enterprise
or industry, and if not, whether there are particular reasons
why it cannot be here or cannot be done to a larger extent,
a greater extent than it is now.
So that's my first one.
CHAIRMAN KASS: Dr. Carson, would you want
DR. CARSON: Yes.
CHAIRMAN KASS: Push your mic.
DR. CARSON: Thanks.
We do have exactly what you suggest. Our validation teams
consist of members as well as non-members. The validation
committee, oversight committee, as well as the site team visits
have members of the CDC on it as well.
MR. ANNAS: Yeah, I may be reiterating your
question a little differently, but I think it would be good
to consider — I never suggested this — having some consumer
groups do some suggestions as well.
Years ago I was on the board of directors of Resolve, for
example, which is a support group for infertile couples, and
their concerns are different. A lot of them are costs and
access and data, but their concerns may be different than
And another group, which I have a number of groups, these
support groups for multiple births, they're obviously mostly
all happy with their children, but they do think a lot more
can be done and should be done both to tell people about the
possibilities of having triplets and quadruplets as well as
try to figure out ways that that number can be reduced.
I mean, the number is going down. Down to four percent is
great, but I think we'd all like to see it down to close to
PROF. GEORGE: You know, we've heard rumblings
on the council, and I've picked up things outside the meeting
room here in talking with people about the possibility that
as the original IVF babies are now entering their 20s, there
are concerns that unanticipated diseases or defects are emerging
so that the problem goes beyond simply the multiple birth
problem, but perhaps some of the fears that people originally
had about IVF are being born out.
If that were true, I take it that it could be a significant
embarrassment to this industry and perhaps damage it in the
public eye, and it looks to me like that's a particular area
where the industry itself probably would be better off if
there were some sort of external report on that investigation
and report on that in the end rather than the industry itself.
CHAIRMAN KASS: Dr. Carson.
DR. CARSON: Well, let me just point out
that ASRM does — we have active collaboration with both the
AIA, American Infertility Association, and RESOLVE, and have
a long-term collaboration with RESOLVE. We have members at
our meeting, board meetings, and so we have considerable consumer,
if you will, and what I like to say, patient input into our
policies and guidelines.
In addition, we work with not only the CDC, as I mentioned,
but also the FDA, and the FDA now has worked with it, has
undertaken upon itself to look at all research procedures
with human tissues, including gametes and embryos, and we
are working in collaboration with the FDA to help them with
some of their guidelines and have their input.
In terms of public disclosure, we actually don't feel that
self-regulation is embarrassing, and I think it's because
our attitude towards this is not punitive, which is not to
say when this all initially started that we weren't very paranoid
about what was happening and government regulation.
But I think that what has happened is we're very proud of
the product that we have and what has happened, but I think
our attitude is not one of making people public spectacles
of their mistakes, but rather of correcting it, teaming them
with a successful program that has the correct procedure,
and then monitoring their outcome and making sure that they
did, indeed, correct that procedure.
In terms of long-term outcome, of course, it's something
that we worry about. It's something we should worry about
with everything in medicine. We can't predict what's going
to happen with any medical procedure 20 years from now, and
that includes any drug you take or any surgery that you have,
and IVF is certainly one of them.
CHAIRMAN KASS: Alfonso Gomez-Lobo and then
DR. GÓMEZ-LOBO: I had yielded, but
I take it back. I had yielded because Dr. Carson was kind
enough to answer one of my questions, but I think it's of
general interest to do with the appointment of the ethics
committee, which of course that would translate if there is,
say, something like federal regulation into a similar problem.
And let me repeat the question. How is the ethics committee
appointed? The reason to us is, of course, because the impact
of the decisions of the ethics committee seem to me to be
In the report that I read, the committee made — the report
on donating spare embryos for embryonic stem cell research
— the committee took a position in a major dispute concerning
the question of respect or, as it's called in the report,
special respect for the human embryo.
DR. CARSON: Let me just give you a little
bit of history of our ethics committee. the ethics committee
was really started in 1985-ish, between 19 — I'm not exactly
sure — 1983 to 1985, by Dr. Howard Jones, and initially it
was really just started as an almost discussion group with
any real charge.
And Dr. Jones felt that we should be talking about IVF and
talking about the ethical issues and bringing them to this
society, and you've heard Dr. Annas' early experience with
the ethics committee. Even the first formal committee with
Dr. Ryan in charge didn't quite have the charge of an ethics
committee that one would expect.
And I'm glad to see that we've, perhaps because of your
advice, we've matured into a committee that is now on the
right track with looking at the safety, efficacy, and patient
confidentiality and privacy of these procedures.
Our committee appointments are actually appointed by the
president of our society, but they are upon the recommendation
and curriculum vitae review of the chairman of the committee,
and the president is submitted recommendations and CVs for
the various interest groups.
We have incorporated a member of our affiliate societies
on the ethics committee, but now we are going to actually
mandate probably that a member of the executive committee
of each affiliate society be on the group because we feel
that this will promulgate more of the policy into our different
CHAIRMAN KASS: Frank Fukuyama.
DR. FUKUYAMA: Well, in listening to these
two very interesting and helpful presentations, it struck
me that the issue here is actually a lot simpler than a lot
of the other issues we've been discussing on this council,
which is that here it's not a question of trying to insert
complex ethical concerns which may not be shared across the
whole society, you know, into some realm of medicine, but
it's fairly straightforward, you know, kind of safety issue
of the sort that we're quite familiar with from drug regulation.
And I think what stimulated this was a couple of earlier
bits of testimony we heard on the council about ICSI in particular
and the fact that the clinical practice in that area and possibly
some others had actually gotten way out ahead of the underlying,
you know, biology and scientific research in embryology and
developmental biology and so forth.
And so there could actually be some fairly straightforward,
you know, simple safety issues involved here.
And so then if that's the problem, then it falls in this
category of asymmetric information which is very familiar,
which is the reason the FDA, you know, regulates drugs, and
I guess the question I would put is if you think that the
FDA, you know, legitimately regulates drug safety, you know,
as a federal government agency, why is this any different?
I mean, why would you argue that you shouldn't apply the same
I mean, forget about the practicalities of whether you can
do it or not, but is there any reason in principle why you
should prefer self-regulation in this case?
You know, one answer actually is that, well, the FDA shouldn't
be in the business of doing this. We should rely on tort law
or we should rely on the, you know, self-interest of drug
companies not to poison people and to, you know, maintain
I mean, a lot of the same arguments that you make about,
you know, the clinics that are in your organization could
apply to the drug industry as well, and yet we don't accept
that. We say that there's a very severe asymmetric information
problem, and therefore, you need, you know, all of these federal
incentives to get that information out to consumers about
safety and so forth.
So that's the question I would put to either of you.
DR. CARSON: Well, first, although we do
work with the FDA, we still feel that self-regulation as we're
doing is more innovative in terms of the problems and also
much quicker. For example, we also feel it might be more flexible.
For example, let's look at, as an example, the U.K. model.
You cannot transfer more than three embryos in the United
Kingdom. It's a law. It's regulated and paid for; can't happen.
Well, I think in the United States we regard the embryo
as an important tissue, potentially human, but not, as I've
said, with the rights of human. But that doesn't mean that
we don't protect and consider that embryo important.
And there are some individuals who for personal reasons
do not want their embryos cryopreserved and do not want to
discard their embryos, and if they have a fourth or fifth
embryo, especially if that embryo doesn't look very good and
we know that it probably won't result in a high order multiple,
that we would transfer that embryo, and we can written in
the document exceed the guidelines for the reason and say
we're putting back three healthy embryos and one embryo does
not look bad because the patient did not want to discard it.
And I think that's something that self-regulation can be
flexible enough to have, whereas federal regulation, such
as the U.K. guidelines, cannot.
CHAIRMAN KASS: Please.
DR. FUKUYAMA: Just a follow-up question.
That's always true of self-regulation. It's always quicker,
more flexible, more adaptive, and so forth.
That being said, would you be in favor of ending FDA regulation
of pharmaceuticals because, you know, FDA regulation slows
down drug approvals, very inflexible? I mean, would you move
to a model for drugs, a similar model for drugs?
DR. CARSON: I would move that we can improve
it. I wouldn't say — should I say that the pharmaceutical
companies should self-regulate? I don't think so. But I think
we can improve the FDA policy.
DR. FUKUYAMA: Why are you different from
them? Why is your group self-interest basically different
from the group self-interest of the pharmaceutical industry
in being able to effectively self-regulate?
DR. CARSON: I think because we are involved
with a very intimate practice of medicine rather than an industry.
I think it's a profession that takes care of people whose
outcome is not financial primarily, but pregnancy, children,
healthy families is a very important outcome variable to us
and probably our primary outcome variable, and I think that
makes us different.
MR. ANNAS: And I'd add to that, you know,
the FDA regulates things, as you know. They regulate drugs
and they regulate the drug industry, and actually Congress
has said they can't regulate the practice of medicine, but
I think they could regulate the practice of medicine.
I don't think they can regulate procedures. I really think
that's a whole different thing, and one reason why, for example,
surgery is not regulated in this country except by the tort
system, and surgeons can do whatever they want.
It's not because we think that they're not dangerous. It's
because we have no idea how to regulate surgeons, and added
to the surgery aspects is this intimacy, family building,
privacy, and I just think not only doesn't FDA have the jurisdiction
and would never be given the jurisdiction. I think it would
be inappropriate to have FDA regulate medical procedures in
the doctor-patient relationship.
CHAIRMAN KASS: I have Bill Hurlbut and
PROF. BLACKBURN: I had a question about
the UNOS model, the moral sharing model. One of the things
that is, of course, great pressure on the system is the shortage
of supply compared with the medical needs, and first a factual
question for Dr. Carson.
I don't know whether there's considered a shortage of donated
ova. I just don't know what pressure there is in that.
And then secondly for Dr. Annas, how does that then impact?
Are the situations very comparable or how would that change
or adjust the kind of model you would use in this situation?
DR. CARSON: There are — I'm not sure about
the word "shortage," but there are certainly much
donor recipients, and there are waiting lists for ovum donors.
PROF. BLACKBURN: Thank you.
Yeah, I wasn't even aware if that was the case.
MR. ANNAS: Yeah, I mean, I apply, as I
think I intimated, the UNOS model, federal model, of no payment
in the purchase and sale of gametes for this.
Would that result in a shortage? I mean, they're not like
organs. To get a vital organ, someone has to die in a very
horrible way usually. That leaves their organs intact.
We're actually — I think this is still true — the only
country in the world that has a market in ova and embryos.
So other countries have figured out a way to get around the
shortage problem, and we could, too.
CHAIRMAN KASS: Bill Hurlbut.
DR. HURLBUT: I appreciate the difficulty
of regulating a complex and rapidly changing field and also
acknowledge the good intentions of the vast majority of medical
people involved, and I'm a physician myself and feel for the
goals of this enterprise.
But I'm also troubled and actually have been every since
the beginning of IVF and more so with ICSI by what I perceive,
as I said earlier, to be the lack of foundational safety studies
on this, and then by some of the ongoing practices.
And I mean, if we admit that less regulation is better and
more flexible response is better, still this seems to me a
very special realm of human existence, and take, for example,
ICSI. Your statistics show I think it was 41 percent of births
or cycles involved ICSI now. It was something pretty dramatic.
Yeah, it was very high. I'll get it out.
But my first question is: do you think ICSI is being overused?
And here without accusing anybody of anything, there would
be a temptation to, for the sake of your institutional statistics,
to have a higher incidence of fertilization, which would be
easier to do with ICSI, right?
What do you think?
DR. CARSON: Well, again, it comes on indication.
Now, in this report I'll tell you that our institution has
the highest percentage of male factor infertility in the country.
So you're talking to the medical director of the program with
that high incidence, but that's because we work with a urologist
who is probably one of the country's leading urologists in
male factor infertility, and most of our patients don't —
a third of our ICSI patients don't have any sperm in their
ejaculate. He gets the sperm from the testes.
We very frequently — the average sperm count in the fertile
man is around 50 to 60 million per cc, and very few of our
patients have more than one million sperm total ejaculate.
So they truly cannot have it.
Now, those are truly indicated ICSI procedures. Another
indication for ICSI is a poor fertilization in a prior IVF
cycle, but there are complications, and you can actually cause
the egg itself to divide, and if you do this in an unindicated
patient, you may actually decrease your pregnancy rate.
So I don't think that ICSI is one procedure that is overused
because overusing it may actually retard your outcome.
DR. HURLBUT: Well, what is the percentage
of ICSI in cycles now? Do you know this?
DR. CARSON: I don't have that number off
DR. HURLBUT: I had it somewhere, and I'm
sorry I can't find it, but it was surprisingly high to me,
and if you consider the male infertility is in the 30 to 40
percent range, not all male infertility requires ICSI.
I mean it just sort of seemed worrisome to me, and the reason
I bring it up is because ICSI has been associated with aneuploidy
in normal primates. You said earlier that the difference between
the outcomes may be due to the patient population that you're
dealing with, and yet there are now studies emerging. Richard
Schultz is doing studies of this nature that seem to indicate
that IVF does carry and ICSI also carries some risks that
are not because of the patient population, if you call mice
or rats a patient population.
You see what I'm getting at here. I just — you apparently
feel like these may be problems, but they're not big enough
to justify larger federal regulation. Is that what I —
DR. CARSON: Well, I think that — first
of all, although male factor infertility does not always require
ICSI, by the time treatment gets to IVF, it almost always
does because treatments of male factor infertility per se
is not with IVF mixing sperm and eggs.
A woman can mix sperm and eggs in her own body. So by the
time that couple gets to IVF, almost all major factor infertility
does require ICSI.
DR. HURLBUT: Well, here's another question.
If IVF does carry risks associated with it just, say, because
of the procedure or because the patient population is more
vulnerable to congenital — producing offspring with congenital
abnormalities, is there a point at which one would say that
the procedure is unjustifiable?
I mean, in many dimensions of medicine we wouldn't allow
a drug to be used, for example, if it carried a certain risk,
and there the patient stands to benefit. Here the issue is,
you know, there's a whole other patient.
One of my colleagues doing this work was asked a question,
and he said, "I don't think of myself as an embryo pediatrician,"
but nonetheless we have to consider what is being produced
How much risk do you feel is acceptable? And do you feel
that that risk is being properly assessed by the current method
or should that be a decision for the whole society?
I mean these are very urgent issues, and I understand. In
my own experience in clinical medicine, I'd say that people
who want to have children and can't are among the most suffering
patients I've ever seen, and yet there is a baby coming out
of this, and that makes this a worrisome terrain for me.
DR. CARSON: Well, I appreciate your concern,
and I think you've crystallized the concern of our society
and our ethics committee. The problem is that we don't have
a good model because those men I described can't have a baby
with that. There is no baby without ICSI. If they don't have
sperm in the ejaculate, there's just no way to.
Well, now then you can say: should they have a baby? And,
again, that's an important ethical question that I think,
again, our ethics committee and our practice committee does
Now, if you come to the conclusion that the technology is
available to help them have a child and if you come to the
conclusion that it is acceptable, then you have to understand
that that technology comes with costs, and one of the costs
is that there is an increased risk without an animal model
of a subsequent progeny, and whether or not that increased
risk should be the same for every individual I don't know.
Should we set a limit that we will not have this with —
I've showed you that the increased risk is .8 percent of sex
chromosomal anomalies above live born fertile controls. Now,
of course, again, we don't know what it would be if somehow
some way these patients were able to have babies, and I don't
know how we set that risk.
I don't know whether it should be the same for every single
individual and whether that's for us to decide and mandate.
But we are concerned that we do have follow-up. We try our
best to get these outcomes, and our committee do wrestle with
the very difficult decisions that you've outlined.
MR. ANNAS: May I follow that one second?
CHAIRMAN KASS: Please.
MR. ANNAS: I've probably never been able
to articulate this well, but for some ICSI patients at least,
we know at least for the Y chromosomes deletions that all
of their male offspring are going to be infertile, and the
question that has always fascinated me, and I don't know if
I have an answer for it necessarily, is can an infertility
expert who sees infertility as a major disease and devoted
their life to it produce infertile children? Is that a problem
DR. CARSON: Of course it's a problem. It's
something that again, we do discuss in committees, we do discuss
with our patients, and we require that all of those patients
go through genetic counseling if they have a Y chromosomal
We also offer preimplantation genetic diagnosis so that
those individuals can have females and promulgate that Y deletion.
MR. ANNAS: I guess that's the question.
Should you require that?
I know you say the informed consent model. It's a tough
question. I don't have an answer to it either.
DR. CARSON: That's a tough one.
CHAIRMAN KASS: I was myself next in the
I would like to go back to something that was implicit in
Gil Meilaender's question previously, and it's also triggered
by the way Frank, I think, rather modestly put the kinds of
concerns that are around the table.
Safety, efficacy, and privacy are goods all of them, but
they don't exhaust the goods that are of concern to us in
this counsel and certainly don't exhaust, it seems to me,
the goods that are of concern to us in the area of assisted
reproduction or of reproduction and, therefore, of assisted
reproduction, which is to say that one is concerned not just
that children be healthy, although health is a good, but it's
not the only good.
And I think that we've all gotten so used to the existence
of this practice and welcome its blessings in the relief of
infertility that it's no longer perhaps so much a part of
our consciousness; that this step, beneficial though it is,
represents, as you yourself said, a kind of unnatural development
in human procreation, one which leads to lots of others.
I mean, there would be no question about embryo research
were there not to begin with the extra embryos available.
There would be no question of preimplantation genetic diagnosis
to screen the embryos were one not already engaged in the
practice of having multiple embryos here from which one could
And it does seem to me that as the society looks without
prejudice now, but to look and ask what's going on here, I
think the society as a whole would see not just individual
infertile couples with the desire to have a child that this
technology can satisfy, but the society would see that we've
embarked upon a new way of bringing children into the world,
a new way of parents prospectively exercising some kind of
quality control over their children, not necessarily through
designer babies, but even through just the simple question
of selection, of which the selection of sex of offspring for
nonmedical reasons is already upon us, and if, as Francis
Collins suggested in his presentation, the prospects of screening
embryos for not just diseases but also for traits at least
in some cases he forecast within ten years.
And it seem to me the society might well in thinking about
this say, "Look. Well and good safety, efficacy, and
privacy, but we don't want as a society to encourage sex selection.
The use of sex as a way of preventing sex linked diseases
is only incidentally sex selection. If you could identify
those diseases in some other way and you could identify the
male child who, in fact, was not afflicted, you wouldn't abort
or prevent the implantation of all males."
So society seems to rightly say we don't want to go down
this route and we also don't want to go down the route of
PGD for trait selection, and yet I don't hear anything in
the kind of principles that are now of concern to the profession,
safety, efficacy and privacy, and after that freedom because
you don't want to get in the way of the private reproductive
choices of any couple. They are the ones who are sort of going
to set the bar for what risks they want to subject their child
to, if their desire is powerful enough or they're willing,
in fact, to have infertile male children ad infinitum, who
is the society to say that their desire and freedom should
So thinking now not so much from the perspective of the
individual couples or of the profession which exists primarily
to serve them, but thinking of the community that has a stake
in how children are born, what our relation to them is, what
kind of control we exercise over their origins. The question
is can one be confident that these are matters best left to
I mean, the Canadians have — I'm not up to date as to whether
the bill has passed there or not. I know it was in the third
reading and there are amendments proposed. So I suspect it
hasn't passed — but they laid down some fairly strict guidelines
about what would or would not be permitted and then left other
sorts of things to the question of professional regulation
That's a long winded way of asking whether there aren't
ethical concerns that are not exhausted by the ones that are
highlighted by you that are concerns to the society as a whole,
and if so, whether the professional society would welcome
the guidance of the community as a whole on those matters,
leaving you free with respect to the things that are not thereby
set out of bounds.
How are we supposed to think about those sorts of things?
DR. CARSON: Well, actually on my last slide
that was actually, I think, my first question to your committee.
I think that you've pointed out these are complex issues,
and I don't really know the answers to your questions, and
we are concerned about whether we really are asking all of
the right questions. What else are we doing?
For example, let me just share a personal vignette. I was
absolutely certain I was not going to give candy to my first
child and he was going to get carrots and celery and only
healthy things to eat.
And then, you know, his grandmother gave him an M&M.
Well, that ended that, right?
And this is just to show that my experience as a parent
changed radically before and after I was a parent, and of
course, most of our couples are not parents, and we as physicians
try to guide them and help them make this decision that we
have from the experience of being parents, of being professionals,
but there's a certain point that you can lead horses to water,
but you can't make them drink, and the point of making them
drink with regulation and with mandates is set by each different
And I think personally that the self-regulation is a better
model for the instance that I described that allows us to
be a little bit more flexible. It allows us to incorporate
the different diversity and ethnic values to embryos that
our different religious and ethnic groups have in this country.
Without that flexibility and with mandated transfer of only
three embryos, we won't be able to respect all of those things.
Should they be respected? Should we have a mandate?
I don't know. At current we don't, and those are some of
the issues that perhaps we're not looking at enough, and again,
we welcome any suggestions that you have in terms of areas
that we're not looking at and ways we can accomplish that.
CHAIRMAN KASS: Okay. I just have a couple
more unless people — thank you.
I have Mary Ann and Rebecca Dresser.
PROF. GLENDON: George, I have a question
for you. Thank you for your presentation and for identifying
yourself in the beginning as somebody who is pro regulation,
and I'd like to ask you a question about that.
Because it seems to me that in the background here, not
just in ART, but in a whole range of analogous issues, the
question isn't just self-regulation or no regulation. It's
self-regulation plus which kind of regulation.
And you a few minutes ago said "except for the tort
system," and I wanted to come back to that and ask you
whether when you discussed the weaknesses of self-regulation
you also had in mind the weaknesses of the tort system, you
as a lawyer had in mind the weaknesses of the tort system
as a method of regulation in the medical area.
Because it seems to me that that system might just be the
worst of all possible worlds, and I say that partly because
my colleague at Harvard Law School, Paul Weiler, did a study
of medical malpractice litigation, which showed, on the one
hand, that most injuries from medical malpractice remain uncompensated,
but on the other hand, the awards that are given in medical
malpractice cases are often on little evidence and grossly
MR. ANNAS: Well, certainly I don't agree
with everything your colleague found in his study, and Troy
Brennan and others have done other studies, but there are
certainly problems with the malpractice system. Nobody likes
the system. It mostly leaves most people uncompensated and
only works well for quite public injuries which have large
payouts, and even then we can wonder whether they're too large.
And it doesn't work at all, as far as we can tell, or very
poorly for deterrence, for quality assurance.
Everybody agrees with that more or less, but nobody agrees
what to do about that, and that's one of the debates we're
having now in this area, but I agree it's not a good system,
but you can't just throw it out. You have to replace it with
something that's better, and you need to know what your goals
are in terms of compensation and quality control and giving
the public a form in which to vent its frustrations.
But in terms of reproductive technologies in general, it
works even worse there. At least historically it has worked
terrible there because people wanted to keep their infertility
a secret. That's no longer the case, but historically that
was the case.
So you have hardly any suits at all involving artificial
insemination by donor, and even to this day most of the lawsuits
— Dr. Carson is exactly right — involve what essentially
are custody disputes, you know, who's going to get the baby
when it's all over.
You see hardly any lawsuits involving problems with the
child. Most of those are not going to be directed at the IVF
clinic anyway. They'll probably be directed at the obstetrician
or at the hospital.
So if you want to regulate new uses of like ICSI, you can't
do it with tort, which is too blunt. I mean, maybe it will
turn out that there are problems and there will be a class
action lawsuit in 20 years or something, but it's not going
to do any good for current practice.
DR. HURLBUT: Let me just clarify the record
on this. I found the statistics.
MR. ANNAS: Okay, good.
DR. HURLBUT: It was slightly higher than
I had thought. The total of all the cycles done was 42.6 percent.
So there might be reason to think ICSI is being overused.
DR. CARSON: And malpractor infertility
is about 40 percent of infertile couples.
DR. HURLBUT: Not all male factor requires
ICSI. So that could be said.
DR. CARSON: that's correct, but also some
of those couples are repeat cycles, are repeat cycles. So
if a woman doesn't get pregnant, she goes through another
cycle, and that would be another ICSI.
DR. HURLBUT: Okay, but do you think ICSI
might be being overused is really the question. No?
I mean, I'm asking you. I'm not —
DR. CARSON: I don't think so because I
think the overuse might cause a problem, and so the motivation
to have a higher success rate would not be achieved.
CHAIRMAN KASS: Before I call on Rebecca,
George, would you mind? I had meant really when I had put
the question to Dr. Carson also to address the question to
you, my own question about whether or not the criteria of
safety, efficacy, privacy, and in some way freedom of choice
are sufficient in this area, given what's actually at stake
and whether you yourself think that one could rely on professional
regulation to perhaps set some of the boundaries toward appropriate
and less appropriate uses of this technology, especially when
you combine it with prospects of selection and the like.
I mean, is this a matter to be left to the private choices
of the consumers or do you yourself favor or think it's reasonable
to develop some kind of —
MR. ANNAS: It sounds like a leading question
CHAIRMAN KASS: I don't know the answer.
I don't know what you would say.
MR. ANNAS: Well, that's okay.
Safety and efficacy are obviously things that we should
take for granted. That's what FDA does with drugs and devices
and we shouldn't expect physicians to offer procedures that
aren't safe and effective.
The problem with this area has been that the federal government
never funded any research. So we're doing kind of research
and practice together. So safety and efficacy are reasonable
goals, but you wouldn't expect from any physician.
Privacy has some unique aspects in this particular area,
but has tended to mean let the couple decide whatever they
want to do, and that's fine as far as it goes as long as the
interests of children and society are factored in there.
And the question is: how do you get the interests of children,
which I have always thought should be first, but it's hard
to put them first; how do you get them accounted for?
But the British system you heard a presentation. In the
British system, there it's in their statute that the best
interests of children shall be the number one concern of their
regulatory agency, and that the interests of the nation shall
take precedent, whatever those are, shall take precedence
over the interests of the couples, a very interesting concept
as well, you know. So see how they figure that on what the
interests of the nation are exactly. It's a good question.
But there the regulatory agency is tasked to figure that
out and to have that reflected in their decisions.
And I certainly think that — and I doubt SART disagrees
— that we have to broaden the players and the discussion
into how we set these rules.
I mean, not to come back to my colleague John Robertson,
but he is the chairman of the ethics committee, and I was
pretty flabbergasted to read in the January 2003 issue of
Nature and Genetics that he believes as a personal matter,
not speaking for the society, that PGD is perfectly appropriate
to use for deafness and it's perfectly appropriate to use
it to help a deaf couple have a deaf child, to have a healthy
child, but to have a deaf child.
That strikes me as something physicians cannot be involved
with. There's no way to say that that is a technology or that
that is a health child. Even if the deaf community considers
it a healthy child, the greater society does not and I don't
think should promote the technology for those type of researchers.
He also says he believes that and he says evidence indicates
that when new uses of PGD help parents to have healthy, wanted
children, society will accept them.
Well, we need society to say that, not to have some person
with a preformed view say that.
CHAIRMAN KASS: Thank you.
Rebecca Dresser, please.
PROF. DRESSER: On Mary Ann's point, one
thing I've heard about the tort system in this area is that
if you're looking at harm to a child, the difficulties in
proving caution are so high or so severe that lawyers won't
take the case, and they just don't get into the system.
PROF. GLENDON: Can I just?
PROF. DRESSER: Sure.
PROF. GLENDON: What I was thinking about
really is down the line the harm to the women that may appear
later on as a result of the massive hormone injections.
PROF. DRESSER: Yeah, that's a possibility.
The other point I wanted to make is I think this discussion
brings home something I keep harping on. This safety and efficacy
is an ethical judgment. I mean, it's balancing. Are the risks
so great that the benefits don't justify doing the procedure,
or what are the benefits? How valuable are they?
And here in this area, how much value you put on the opportunity
to have a biological child makes a huge difference. If you
don't think that's very valuable, then the ICSI risk is unjustified
and the ICSI is unsafe.
If you think that is incredibly valuable, then a 15 percent
risk in ICSI of certainly infertility, which, you know, people
can have a very good quality of life if they're infertile;
so that risk would not be so high, and you would say — or
too high — and you would say the procedure is justified.
So who gets to value risks and expected benefits is crucial
in this area, and you know, the FDA does it with drugs, with
their advisory committees which do often include patient representatives.
They have gotten a little bit more diverse in terms of the
In this committee, the ASRM ethics committee, the people
on the committee are balancing these things, and whether they're
the appropriate ones to be doing it is a good question, and
obviously the infertility patients are valuing these things,
and they're putting an incredibly high value on having a biological
So I think we should keep remembering that the safety and
efficacy, oh, well, that's something different than ethical.
To me that —
CHAIRMAN KASS: No, I regard them as —
PROF. DRESSER: — that's crucial.
CHAIRMAN KASS: I regard them as ethical
PROF. DRESSER: So if we could ever get
the legislature or Congress to take a stand on, you know,
the value of the healthy child in this context is paramount,
and you know, we will accept very few risks to the physical
health of the child or the psychological health. That would
be, you know, in a democracy that would probably be ideal,
but it has been difficult to get our legislators to take a
stand on something like that.
CHAIRMAN KASS: Well, having the somewhat
ill deserved reputation I have of being an enemy of IVF is
tied to a paper written in 1971 in the New England Journal
after the first successful laboratory fertilization by Edwards,
I guess seven years before Louise Brown.
The question was whether this was unethical experimentation
on the unborn, question mark, and the sole concern was, in
fact, George Annas' concern to say that one shouldn't be simply
guided by our sympathy for the powerful desires of the parents.
There is a third party here for whom it's not yet clear that
the prospective parents who don't yet have the living child
in front of them to care for have the best interests of that
child in mind until, as Dr. Carson says, the child is there.
Look. Unless someone wants to add, we're late. We had originally
budgeted half an hour here for the council amongst itself
to discuss the fruits of this discussion. Our guests have
been forthcoming and we've not been shy, but I don't think
we've cheated ourselves out of this.
Let me simply say that we will build in our discussion of
strengths and possible weaknesses of professional self-regulation
when the staff brings to the council at our next meeting its
preliminary document for discussion on our review of the current
situation of regulation in this area, with special attention
to the ethical issues, including safety and efficacy.
Let me thank Dr. Carson and Professor Annas very much for
your presence, for your generosity, for your clear presentation,
and the wonderful way in which you responded to the questions.
Thank you very much.
If I could ask counsel members, briefly we have only one
presentation, one person to speak in the public session, and
that is Richard Doerflinger from the U.S. Conference of Catholic
Thank you both very much.