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Friday, March 7, 2003

Session 6: Biotechnology and Public Policy:
Professional Self-Regulation

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 of Law

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 there.

George Annas, thank you very much for joining us. The floor is yours.

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 Real Issues."

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 everything else.

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 as well.

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 level.

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 obviously.

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, as well.

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 relationship.

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 regulations.

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 else?

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 be one?

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 most especially?

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 been involved.

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 do it.

CHAIRMAN KASS: Thank you.

Elizabeth, please.

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.

Please, Robby.

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 well.

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 to respond?

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 a profession.

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 zero.

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 Frank.

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 enormous.

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 subgroups.

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 model?

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 their reputations.

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 then Elizabeth.

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 the top.

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.

Go ahead.

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 here.

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 wrestle with.

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 or not?

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 deletion.

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 queue.

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 then choose.

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 not rule?

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 self-regulation.

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 and discretion.

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 country differently.

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 excessive.

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 to me.

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 value judgments.

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 child.

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 concerns.

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 Bishops.

Thank you both very much.

(Applause.)

 


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