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Thursday, January 15, 2004

Session 2: Biotechnology and Public Policy

Staff Working Paper, "U.S. Public Policy and the Biotechnologies that Touch the Beginnings of Human Life: Draft Recommendations, Revised"

CHAIRMAN KASS:  Thank you.  Welcome to Janet Rowley.  We are expecting Mike Gazzaniga and Charles Krauthammer, who are both in transit.  This is the second session on biotechnology and public policy, and is devoted to a discussion of the staff working paper, entitled, "U.S. Public Policy and the Biotechnologies That Touch the Beginnings of Human Life:  Draft Recommendations, Revised."

I think council members don't need much by way of rehearsal of what this project is, or what we are doing, and why.  Suffice it to say that we have for some time, really from the very first meeting, been interested in the monitoring and regulatory institutions that concern the uses of biotechnology in general, and that we focus that interest on the technologies touching the beginnings of human life where already established technologies of assisted reproduction now become joined with possible new developments growing out of genomic knowledge, and the availability of embryos for research.

We are on our way toward a report on this subject, the bulk of which will be a diagnostic section of some length reviewing where things now stand. 

A brief section already has been discussed and basically approved on policy options, both general and particular, and a last section which we discussed both in September and in October on interim recommendations, recommendations for the time being while the Council and the Nation continue to deliberate about what if anything needs to be done to improve the way in which we now oversee, and monitor, and regulate these activities.

We in September had a discussion of the first draft of these recommendations, and it was a very spirited and somewhat woolly conversation.  We returned in October, where we made I think considerable progress amongst ourselves.

A number of things were clarified, and a number of issues in which it looked like we could find no agreement, and we managed to produce a kind of agreement amongst us. 

And the document has been changed extensively to reflect those conversations amongst ourselves with a number of things being removed that were contentious, and other things being refined.

I will say, and I think that I would like to put in the record that this latest draft also reflects changes that we have made in response to comments by various stakeholders, including patient groups and professional societies.

We have met with the — we already met the last time with the President and the Executive Director of the American Society for Reproductive Medicine.  We have since met with representatives from RESOLVE, and from the American Infertility Association.

And I want to go through a few of the changes that have been made, because I would also like to say that to some extent the concerns of some of these groups have originated from at least a partial misunderstanding both as to the substance of our document, and our intentions.

Nevertheless, they have offered some very helpful comments, calling our attention to ambiguities or to problems that we might be causing of which we were not aware.

And we have responded in great detail to some of their concerns, and so that Council members don't have to sit with the last draft and the current draft, let me just highlight a few of these concerns, and put on the record some of the things that we have changed.

First of all, there has been a concern that some of the monitoring activities that we were calling for would produce government intrusion and stigmatization.  That we were calling for measures that would involve undue intrusion of government into the domain of ART.

That we would lead infertile patients and their children to be stigmatized by being monitored and registered, and that there was a concern that the studies that we were calling for might imply mandatory participation and create a de facto registry of children born with ART, though that was not our intent.

We have modified the document to expressly state that participation in all Federally- funded studies should be fully voluntary as we had all along intended.  We removed the recommendation that the ART children be tracked through the first year following their birth, thus avoiding the inadvertent creation of a mandatory government registry of such children.

We have modified the document to note that the vast majority of our recommendations requesting additional information calls in fact for the publication of data that is already being collected by the CDC under the Wyden Act, but not made public.

And we have eliminated from this document our recommendation relating to the tracking of in vitro embryos produced during ART.  There has been some concern about sowing alarm and confusion about some of the terms having to do with the way that the data is reported, and the reporting of costs.

And I won't bore you with the details, but we have put in suitable modifying language to address those concerns.  A major concern was that our recommendations might lead to restrictions on access to assisted reproductive technologies, and the reasons that were given included the following.

That the recommendations for increasing reporting and monitoring might give rise to increased costs, which would then be passed on to patients due to this requirement of increased oversight. 

That people sensed that there were certain restrictions that we were recommending on the use of embryos in clinical and research contexts; and third, that there were restrictions on certain practices that were integral to ART, such as gamete and embryo donations, surrogacy and the like.

Partly, this, I think, rested on misunderstanding, and partly there were important issues to be discussed, and the new draft makes it expressly clear that our recommendation to increase the CDC's funding is aimed precisely at shifting the costs of any new oversight activities to the government rather than to the patients.

The draft makes it very clear that we are not calling for in vitro embryos as such to be treated as patients or human subjects of research, and the language that led some people to think otherwise, such as "child to be," or "future child," has been replaced with "children later born."

The concern throughout is to make sure that we safeguard the health and well- being of the children who are born as a result of these procedures, and that was always the intent.

If the language was confusing, that has now been eliminated, and the new version makes it clear that we are not calling for any kind of ban on gamete or embryo donation, surrogacy, the reimbursement for reasonable expenses incurred in the course of such practices, et cetera, et cetera.

So I think that we are very glad that these concerns have been called to our attention, even in places where we think they rested on some partial misunderstanding, and I would like to think that the new version of the recommendations addresses the concerns of the stakeholders, as well as the concerns of the Council members.

The goal for today is I think simple.  We were very close I think to an agreement on most of the things that are here.  The recommendations in the interim recommendations are in three parts:  (1) Recommendations for Federal studies, data collection, reporting and monitoring, regarding the uses and effects of these technologies; (2) recommendations for professional — for increased oversight by the professional societies and practitioners; and (3) recommendations for targeted legislative measures to defend the dignity of human procreation. Those are the three sections.  And my goal today, and I think we should be able to achieve it, is to try to reach the agreement on the gist of these provisions, leaving the line editing and refinements for later.

The rest of the document has been reedited, and will be sent to you shortly with a revised version of what we are talking about today, so that you will fairly soon be able to see the whole thing.

Given where we were on the stem cell report, and we didn't feel it was appropriate to burden you at this time with yet another hundred pages of document to be read carefully.  So that is coming next.

Any questions or comments on my opening remarks or on the procedure?  Frank, are you — you looked like you were on your way to say something?  No?

PROF. FUKUYAMA:  I have several things to say, but not now.

CHAIRMAN KASS:  Okay.  A note has been passed to me, and I might as well read it, that Jim Wilson, who is unable to be here, did send in a note saying that he endorses this document as written.  So that is at least in the record and on the discussion.

Shall we begin and go section by section, and not necessarily article by article, and see whether people have comments in the large, first of all, about the particular items recommended.  And Janet Rowley, please.

DR. ROWLEY:  I was not able to be here at the October meeting, but I did raise a point that I think is very important in the September meeting, that I don't believe is really addressed by the draft that we have currently. 

I think it is very important that we recognize that the problems that we are facing, that this draft is trying to correct if you will, are due to two factors. 

One is the Congressional prohibition against funding any research related to embryos.  So there is much of the text that relates to the fact that the procedures, and changes in procedures, are often not as carefully documented as they would be in other kind of medical procedures, and it is strictly a result of the lack of appropriate and adequate funding.

So all of the research that is done is paid for by fees from patients to various clinics.  So this should be part of the preamble; that Congress has really forced many of these problems because of its prohibition.

The second problem that arises is that from the standpoint of patients this procedure is not covered by health insurance.  As a consequence some of the other aspects that we are concerned about, such as multiple pregnancies, which do not happen in other countries where they have appropriate funding of patient care, do happen here because the clinics are — if you want to have a successful pregnancy, you put in multiple embryos, and this is recognized as a less than ideal medical procedure.

But it is strictly a result in this country of the way that we fund or do not fund health care for this particular medical problem.

CHAIRMAN KASS:  Any comment to that? 

PROF. MEILAENDER:  A question, just a question.

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  Congress doesn't forbid all research on embryos does it?  It forbids research that involves destruction of embryos by Federal funding of such research.  Am I not right about that?

We don't have any law forbidding research on embryos.  We have law prohibiting Federal funding of research that destroys embryos.

CHAIRMAN KASS:  I think Janet's point would be something like this.  That attached to funding is very often the obligation for a certain kind of review, and that in the absence of a funding policy the government has lost — in Janet's view, has lost something of its leverage to actually regulate the funded activity.

And I don't think she was saying that this is outlawed, that the activity itself is outlawed.

DR. ROWLEY:  Well, it's in — I stand to be corrected by people who are more conversant with the specific details of the law.  But any sort of research trying to see whether Procedure A is more likely to give you viable embryos or viable embryos of higher quality, is inevitably going to lead to some of those embryos dying.

And that's because you are trying to see what you can do to improve it.  So I think that it is unrealistic to think that you can fund research on embryos that is focused on trying to improve conditions without as a necessary component of that being some research that would lead to the death of embryos.  And science is about comparing things.

CHAIRMAN KASS:  Robby.

PROF. GEORGE:  Janet, I just wanted to ask a question of clarification about your comment.  There were two parts to it.  The first had to do with what you take to be the implications of the prohibition on Federal funding of embryo research or research that involves the destruction of embryos.

But as I understood your second comment, and this is what I wanted to be clear about, your second comment doesn't have to do with that?

DR. ROWLEY:  No.

PROF. GEORGE:  Your second comment is a more general criticism of the health care system in the United States, comparing it unfavorably, say, with the European systems.  That wouldn't have anything to do with whether embryo research is funded or not funded.

You are just saying that if we had a better and superior health care system overall that we would be relieved of such problems, which I would agree are very serious problems of, for example, multiple pregnancies, and the practice of implanting multiple embryos, with a view to having at least one survive and so forth. 

Just have I understood you correctly?  I am not here arguing with you.

DR. ROWLEY:  Right.  No, I think that is correct, and what I am saying is that these two factors play a central role in the problems that we are now trying to fix, but we are fixing it around the perimeter, and we are not dealing at all with some of the fundamental causes that lead to some of the concerns that members have.

And I think not to state this right up front is in my view a major deficiency of this particular document.

CHAIRMAN KASS:  Let me offer a comment in my own name, Janet.  I think — I take your point, and I wouldn't deny the relevance of both of those considerations to the situation that we have. 

But I think on the first point that when similar comments were raised in the past, there were responses to say that there are all kinds of things that the government can and does regulate that it doesn't fund.

And indeed the Wyden Act to require the reporting is an Act that Congress was able to enact, even though it could not get past funding for the embryo research itself.

So it makes it more difficult, I grant, but the Government regulates lots of activities that it doesn't fund, and therefore one cannot simply say that the reason that this is an unregulated area is solely due or primarily due to that.

It is a factor, but I wouldn't share your interpretation that that is the cause.  And second even on the question of health insurance, the profession has in fact tried very hard to set guidelines to reduce the number of embryos that are transferred.

There is professional self- regulation, and we are in effect calling on the profession to do more of that.  You don't need a national health insurance to practice responsible medicine, and it might help to remove certain kinds of financial disincentives to practice responsible medicine.

But again I wouldn't say that that is the sole explanation for what we have here.  I am very happy to include the points in the analysis, but I am not sure that I would include them as determinatative, (a), and (b) in the recommendations, you will recall that we are trying to look for those things that we can recommend, notwithstanding certain kinds of unbridgeable differences amongst us.

DR. ROWLEY:  But I would like to come back to this, because I think that we have agreed that the government requires things that they don't fund, but I think so much of the text is that the technologies that are being used are experimental, and new technologies are put into place that are in one sense experimental.

And to decry that, and then to say that you can't put new technologies into place without having them thoughtfully and carefully evaluated, but we won't fund any of that evaluation on a larger scale, I think this puts us in the hypocritical state, which I suspect we would prefer not to be.

The second thing is that there is a great emphasis here on making — and coming to my second point, making information available to patients about the success rate of clinics.

And to the extent that we tell clinics that it is important to use fewer embryos, their failure rate is going to go up.  This is going to reflect in the statistics. 

So the more responsible clinics that use fewer embryos will look worse in just the kinds of statistics that we are collecting.  And again I think that we have to recognize the forces that are driving all of this, and I think not to be honest about the forces is to undermine some of what we are trying to do.

CHAIRMAN KASS:  Mary Ann.

PROF. GLENDON:  Yes.  We are in the preamble, I gather, and the preamble states, or the introduction states that it would be premature at best to recommend dramatic legal or institutional changes.

Since a reference has been made to what is done in other countries and countries specifically with national health insurance, I thought that it would be interesting just to notice that I am reading from a January 11, 2004 summary of recent European legislation on this topic.

Many of these countries prohibit the freezing of embryos, limit a couple to 2 or 3 embryos, and some countries prohibit donations from third- parties, limit in vitro fertilization to heterosexual couples; prohibit genetic testing on embryos; proscribe cloning or experimentation on embryos.

And so it is worth noting that there are a number of countries that do not think it is premature to take more extensive measures than the very modest ones that have been recommended in our report.

CHAIRMAN KASS:  Frank.

PROF. FUKUYAMA:  I guess, Janet, I don't understand the objection, because the FDA regulates drugs.  You know, requires extremely expensive clinical trials that drive up the price of drugs, but the Federal government does not fund the development of — I mean, it may in some cases fund the development of new drugs, but it does not — you know, you don't question the legitimacy of its regulation of private sector activities in drug development simply on the grounds of the level of funding, Federal funding, for drug development.

So I don't really understand the two are necessarily related.  I mean, if there are serious safety considerations that are raised by private sector activities in this area, it seems to me that the Federal Government would have an interest in looking at that, regardless of whether it funds these activities itself.

DR. ROWLEY:  But, Frank — I mean — I don't think that is really relevant, because the drug companies after all are able to incorporate the cost of drug development in the cost of the drugs, and I am not aware that any drug company is on the street bankrupt at this point.

So I think that we are talking about activities which — the research for which is funded by patients out of their discretionary funds, and I think it is a totally different matter. 

DR. FOSTER:  I was going to say the same thing.  In principle, what you say is correct.  But corporations have big funds for research.  You pay for it in the drug, but none of these people — I mean, it is a very expensive thing to have in vitro fertilization, but nobody is getting rich out of that.

I mean, if you just look at the incomes, and the doctor's incomes and the nurses, and so forth, which are there, there are no — as far as I know, there is nobody getting or has any excess surplus funds that you could do expensive laboratory or other research.

So I think that — I agree with Janet that that doesn't — that this is one of the rare times which I think that your comment doesn't apply, okay?

CHAIRMAN KASS:  Frank.

PROF. FUKUYAMA:  I mean, Congress just passed one of the biggest new entitlement bills for drug benefits precisely because the requirement for drug testing has driven up the cost of pre- drug development up in this country and people cannot afford it. 

So I just don't see in principle — I mean, it is true that the structure of the ART industry is very different from that of the pharmaceutical industry, but part of the reason that you got this structure of gigantic corporations is precisely because of the regulatory burden that is placed on drug development by the FDA.

So, yeah, you are absolutely right.  It is going to drive up — I mean, some of these things are going to drive up the cost of these kinds of treatments, and they will have to be borne out of the pockets of the people that want the treatment.

But again I just don't see how this is any different from private sector drug development.

DR. FOSTER:  I do want to say also without being — I love the drug companies.  They are making wonderful new drugs, but I don't have the latest figures, but I believe the evidence is pretty overwhelming that they spent more money on advertising and doctors in luxurious parties than they do on research and development.

So, I mean, I think that is a very — it is not fair to say that the cost of the drugs are solely because of regulation for safety on the FDA.  I mean, if you look at these budgets, I mean, they are obscene about some of the things that are done at scientific meetings and so forth.

I mean, that is probably irrelevant, but I had to say that because it gets my spleen up; that when everybody says that because of the drugs the FDA is the cause of this.  I think we ought to be very thankful that we have an FDA that is trying to carefully look over these drugs, and particularly the second level drugs and so forth that go on.

I happened to hear the Commissioner talk this week at this meeting in Texas, and he points out and defends even the approval of second — you know, "me- too" drugs, and drives the costs down, and so it probably — you know, I don't know much about the FDA, but I think that we shouldn't blame them for these costs exclusively.

PROF. GEORGE:  Dan, you have whetted my appetite.  What are these obscene things that happen at scientific meetings?

CHAIRMAN KASS:  No, let's —

DR. FOSTER:  I should not use that term.  The obscenity is gluttony of food and drink, that's all, and nothing to do with anything immoral, okay?  Please do not saddle me with that.

CHAIRMAN KASS:  Let me try to resolve this.  We will certainly take Janet's comments into account in the new draft.  One word on the costs, and the cost was an issue already raised, and we have indicated at least with respect to the call for additional Federal activity that the funds ought to be provided as they are now provided to the CDC for any additional activity that the CDC would undertake.

So that this would be an attempt not to pass those costs on, or at least that is our — we are cognizant of that fact.  Let's go from the preamble actually to the particular recommendations and in Section 1.

Welcome to Mike Gazzaniga, who is happily down here where the temperature is only 30 degrees instead of minus 30.  Oh, and Charles, welcome to Charles Krauthammer.  Sorry. 

Section 1, beginning on page 3, we are just beginning to review the particular recommendations on the Federal studies.  And since we could go one by one, but let me — and since I think that this is relatively okay, why don't I simply put the whole of the materials from page 3 through page 10; the Federally- funded longitudinal study on the health and development implications of ARTs on children.

And we have had very good conversations with the people designing the National Children's Study, and we are hopeful that they will be willing to include this as part of their study.

To undertake Federally- funded studies on the impacts of ARTs on women, on the uses and effects of reproductive genetic technologies; strengthen and augment the Fertility Clinic Success Rate and Certification Act with specific provisions on reporting requirements.

And on enhancing patient protection and implementation.  These have been streamlined and changed in ways that I already indicated.  Are there questions or comments on any of these particular items?  Gil.

PROF. MEILAENDER:  My comment is with respect to something on pages 6 and 7.  It is under the enhanced reporting requirements, (b) I guess it is, risks and side effects.

I would like to see us restore a sentence that was in an earlier draft, but is not there any longer.  I don't know whether the rest of you will think it is worth it.  But I preface this by saying that sometimes when you bend over backwards to be accommodating, you simply get kicked.

And that seems to me to be happening here.  I mean, we have before us a news release from RESOLVE about what we are supposedly doing today that is inaccurate in almost every respect. 

And this was one of the stakeholders that we were worried about.  What I would like to see us do is add at the end of that paragraph that goes over on to page 7 a sentence that simply says this is taken from the previous draft.  ART clinics should be asked to provide data on the incidents of adverse effects on women undergoing treatment, as well as on the health and development of children born using ART at least through the first year of life.

I myself don't understand why anyone wouldn't think that was useful information, and that one would like to know.  Remember that all we are doing is asking for information to be gathered that might be helpful in determining what regulation, if any, would be needed or wise to advise.

It seems to me that this sort of information would clearly be useful, and would be worth knowing.  I don't understand why it dropped out, and I myself would like to see it restored.

CHAIRMAN KASS:  Carter, I may need some help on this, but I think I can understand why it is absent.  First of all the clinics do not follow these children once pregnancy has begun.  They are turned over to the obstetricians, and then to the pediatricians.

Second, in order to do that, you would have to have a de facto registry of children born with ART, and there is a great deal of interest both in the patient groups and in the practitioners, to protect the privacy of the participants.

We thought that we might in fact get the kind of information we were interested in from a longitudinal study in which people are tracked not just through the first year of life, but as long as the study continues, and tracked prospectively such that one would simply happen to know that some of the children in the study had this origin.

And that all of the participants would be volunteers, and we would get the information without having to violate these particularly important principles and concerns, both of the patient groups and of the practitioners.  Carter, have I got that right? 

MR. SNEAD:  Yes, I think that is a fair characterization.

CHAIRMAN KASS:  Carter Snead, who is our general counsel, has been the major — in fact, Carter, why don't you take a seat here, because we might need you in addition.   

MR. SNEAD:  Yes, Leon, I think those were — that was a fair characterization of the concerns that were raised, both the logistical difficulties of gathering that information, and requiring coordination with pediatricians and so forth. There is not right now a continuity between the doctors that — you know, the reproductive endocrinologists, the obstetricians, and then later, pediatricians, that would have to be created.

And then secondly there were concerns about stigmatization of these children through the creation of a de facto registry as you outlined.  I think that is a fair characterization. We thought that we would get the same sort of information through the longitudinal study.

And then additionally — and one thing to add about the longitudinal study.  The National Children's Study, if they were to accept our offer to include this information in their project that they are going forward with, they release their data at certain milestones, such that you wouldn't have to wait for 21 years to get the relevant information.

And so there would be sort of a rolling reporting of the results that they would get.  So basically to accommodate the concerns that were raised, and with the idea that the same information could be gathered through other mechanisms, that's why the document was changed the way that it was.

CHAIRMAN KASS:  Other comments about these original

- - Gil, do you want to —

PROF. MEILAENDER:  I would just put on the record that that does not seem to me to be a sufficiently weighty reason to eliminate it.  It does seem to me to be information that would be useful to have.

I think the registry language is bogus, and there are plenty of ways to protect confidentiality in our world.  And I can't see much hope for any future regulatory agency keeping close watch on these matters. 

If a body like ours that simply is thinking about what information it might be useful to have in order to know whether there should be such an agency, or what it might regulate, already goes belly up at the first sign of pressure. 

So it seems to me that it is useful information and that it would be good to have.

CHAIRMAN KASS:  On this very point, Robby.

PROF. GEORGE:  Yes, I wonder if the staff has looked into it, or if Mary Ann just happens to know, how other jurisdictions — European countries, Japan — have dealt with trying to honor both of these concerns, the one that Gil quite legitimately raises, and the concern about privacy and so forth.

Perhaps there are models that would be helpful to us.  Do you know?

MR. SNEAD:  As far as the jurisdictions that have the most comprehensive approaches to monitoring and oversight of these reproductive technologies, my recollection is, if it is correct, is that there is no jurisdiction that provides for oversight up to a certain — beyond the stage of birth.

So as far as I know, there are no models that would provide useful examples for how to solve the logistical problems of tracking these children and their families.

And most of the registries that are being created abroad, my understanding is that in France and maybe in Belgium, there are sort of Federally- sponsored efforts to track these individuals, and I would have to look more closely at how they go about doing that.

PROF. GEORGE:  Do you know anything about whether privacy concerns have been taken into account?

MR. SNEAD:  I imagine that they have been.  I met with our counterparts at the HFEA in Britain in August, and that seemed to be a concern that was very — that was foremost in their minds was safeguarding privacy.

So I think that they had done that in a way that is satisfactory.  I can't speak to the specific mechanisms that they used though.

PROF. GEORGE:  Well, I would like to request that the staff look into this and perhaps we can satisfy everyone here.

CHAIRMAN KASS:  Okay.  Still on this same point, or are we going somewhere else?  Is it on the issue that we were just discussing?  Mary Ann, is it still on this point?

PROF. GLENDON:  Yes. 

CHAIRMAN KASS:  Please. 

PROF. GLENDON:  I just think it is worth emphasizing how modest the recommendations in this section are.  Nobody is talking about government regulation of a practically unregulated industry.  One is only talking about information so that there can be informed public deliberation of some of these issues, the kind of deliberation that we have in a democracy.

I think that I am just a little skeptical about talk about undue government intrusion, or privacy concerns, when all that is being sought here is information and letting the sun shine into an industry that apparently is bent on keeping its activities from public surveillance.

CHAIRMAN KASS:  Comments still on this?  Mike, do you want to go somewhere else?

DR. GAZZANIGA:  Well, it is related.

CHAIRMAN KASS:  Please.

DR. GAZZANIGA:  I am continuing to read this section and to be able to think about it, and it really comes down to what we are saying, is that we are trying to recommend that epidemiological studies be carried out in IVF.  Why don't we just say that?

Federally- funded, and we would recommend that Federally- funded epidemiological studies be carried out on IVF, period, and not try to play the game of what all that means.

There are epidemiologists who know how to do this, and they do it all the time, and for us to try to prescribe these various this and thats is probably not necessary, and I don't even know that it is particularly informed by the subtle science of epidemiology.

So — I mean, what the intention is, is simply to carry out that sort of activity, but let the sun shine in as Mary Ann says, and there are procedures for — well- established procedures for doing that, and I recommend that we just recommend that.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  Well, I think we are writing this document not just for researchers, and so I think it is worthwhile talking about what the kind of information is that we would like to see to the ordinary person.

I mean, if you just say do epidemiological studies, the ordinary person won't be able to understand that, and I guess I want to second the consumer protection value of this information.

This kind of study would enable people who have children this way to know if there are certain medical problems that crop up more often, so that the pediatrician needs to be looking for them.

This really could promote the health of these children, and so it seems to me that consumer groups should welcome a call to produce more of this information just so that their constituencies can make better informed decisions, and they are usually people who are very concerned about the well- being of their children.

And this kind of information would enhance that ability to show concern for their children.

CHAIRMAN KASS:  Janet.

DR. ROWLEY:  Well, I noticed that Kathy Hudson is here, and I wonder with regard to the question of what other countries do, because I am under the impression that they are some large studies in this matter, whether Kathy could answer or has any information, or —

CHAIRMAN KASS:  Kathy, would you like to respond, if you wish.

DR. HUDSON:  With respect to the question of post- birth surveillance of health of ART children, in other countries I think the situation is quite different, where there are national health records in many countries, and national birth records in many countries, that can be linked.

So you can do studies, albeit retrospectively, of large cohorts of children because of the existence of these records.  So I think where we see the best data is in fact in countries where you have that kind of record system, which of course we don't have in the United States.  Was there another —

DR. ROWLEY:  Well, the question is whether there are any results or whether these studies have a time in which they are going to do the analysis and publish them?

DR. HUDSON:  The European Society of Human Reproduction and Embryology has been doing a very large prospective trial looking at children's health from ART.

And they are now following kids up to about seven.  I think they have reported data on the health of children out to about seven.  I think the existence of that data doesn't negate the need for additional research in the United States, because techniques do vary.

DR. ROWLEY:  Thank you.

CHAIRMAN KASS:  Thank you very much.  Dan.

DR. FOSTER:  Michael, I thought that it was very attractive from this standpoint to try to bond in on the study that is going to already be done.  I mean, that you are going to follow these, and so it seems to me that the modesty of this is also very practical, and the information that we really want to know would come out, and particularly since they are going to have interim reports.

I mean, just look at the Framingham Study and things like that.  I mean, we really need to know whether if you take a cell out for genetic diagnosis and so forth whether that does anything or not.

I think that everybody would want to know that, and so I was really quite enthusiastic about not coming up with some — to say somebody else to do an epidemiologic study, and let's say an agency such as the CDC or something.

I like the idea of trying to just add on — because it is a monumental thing to follow a hundred- thousand kids.  I mean, you know, people drop out of these things all the time, and so I thought that this was a great idea myself.

DR. GAZZANIGA:  Well, let me just comment on that.  I have no problem that the epidemiological analysis goes on within that study.  That study as you know has not been funded.

And they are looking to tack this on to try to get it funded and there are inherent problems with these studies because of the drop out and because you start to dilute the number of factors that you are looking at, and then you can't really say statistically about any of them, et cetera, et cetera, et cetera.

So I think that it is fine in the sense — I mean, in the sense that it sounds right, but in some sense just to recommend funding of IVF might allow it to go forward when maybe that mammoth thing won't go forward.

So you might get locked up in getting what you want to get done here by completely attaching it to that study.  That is just a very practical point.  But that is what we are talking about. 

We are talking about getting it done somehow, and I think just saying it is sufficient.  I mean, then we don't have to get entangled in all these subtleties.

DR. FOSTER:  Well, I heard what you just said about maybe this would enhance, but maybe the sentence that one would add here would be something like that should there be a failure of funding of the child health study or whatever it is called that we would recommend an independent study of the children be funded because this is such a critical issue.  Maybe just a sentence like that added would be helpful.

CHAIRMAN KASS:  Also, let me just say quickly, Mike, that one could preface this with the generic comment that you make, but the particular things that have here been identified are in fact and do grow out of the analysis that we haven't recirculated at this time.

But that we have identified different kinds of areas for an epidemiological study, and we have also talked about the already existing reporting requirements and suggested that there might be some additional things that could be done to augment the publication of data already collected.

So I do think since there are various possible target audiences for this that there is a certain amount of specificity is, I think, helpful.  But I am prepared to — well, these are the kinds of information that we are somehow specifying here.

If we are going on too long about it,and you think it could be streamlined, we could certainly do that.  Anything on the particular concrete substantive things in that first section?

DR. ROWLEY:  As a point of information, Carter, I have been told by individuals with whom I have been discussing this matter that there is in fact a Federal website that is devoted to information about ART, and it is my impression that this is the only Federally funded site on any medical procedure.

MR. SNEAD:  I think what you are referring to, and you can correct me if I am wrong, is the CDC's ART surveillance website, which — is a web publication of the document that also comes out in hard copy that is basically required by the Wyden Act, to outline the success rates and various points of analysis.  Is that what you are referring to?

DR. ROWLEY:  I assume so, since this is information that I have gotten from discussions with others.  We didn't go into great detail about this.

MR. SNEAD:  Right.

DR. ROWLEY:  But it is pointed out that there is no other Federally- funded website about any medical procedure. 

MR. SNEAD:  That's interesting.  I was not aware of that, that there were no other Federally- funded websites.  I know that the CDC has other websites relating to other medical concerns, but I don't know how that bears on your comment.

But that would be news to me if that were the only Federally funded website that relates to a particular procedure. 

CHAIRMAN KASS:  Shall we proceed to the second section?  Robby.

PROF. GEORGE:  One more, Leon, on that question of the possibility of tracking the numbers of embryos that are created, their use and disposition.  My impression is that it is actually very difficult to get reliable information about just the sheer numbers of embryos that are created in the industry, and how they are used, and their final disposition.

If that is true, is there any proposal short of the one that was in the original draft for enabling that to be done?  Or if we don't propose anything here, will it just be continued ignorance about the facts?

CHAIRMAN KASS:  We made a decision simply to remove that section.  There has recently been a study, the RAND study, which has disclosed the numbers.  It would be possible to make a request to produce aggregated data from the various clinics without identifying which clinics.

I mean, the clinics are rightly concerned that publication of such data with their names attached to it would in fact enter into the political turmoil about abortion politics and the like, and they want to protect the privacy of what they do.

There is a case to be made that the Nation as a whole might like to know the answer to just simply the quantitative data.  But we recently had a study which, to the best of people's knowledge, indicated there were roughly 400,000 embryos in cryopreservation.

And I guess the question is what difference would it make if we commissioned a study which produced the number of 600,000, or 300,000, or 1 million.

It seems to me the number — we know that there are lots, and since this is not — since we don't have a policy here to recommend on what should be done there, it seemed to be to call for that kind of data collection at this point, knowing that the number is very large already, seemed gratuitous, and off the main point.

If there is strong feeling that this should be restored, I am not unhappy to restore it, but it didn't seem to me to be essential to what we were talking about here. 

PROF. GEORGE:  Well, if we could get the information another way, I would be very open to that, but I think that the information is potentially relevant to public policy mix and the kinds of people that we are attempting to serve. 

I think it is.  I mean, as we go forward just being able to compare what goes on here with what goes on in other jurisdictions that have other sorts of regulatory schemes or have regulatory schemes at all, I think would be potentially at least very valuable.

CHAIRMAN KASS:  It certainly would not hurt anybody to know the answer.  But let me simply ask, is there anybody who would object if there were simply a restoration of some kind of request for information on the number of embryos created and stored? 

Do we regard that as an important piece of information that people want to know in this area or not?  Yes, no, maybe?  How many think that this is information worthy to be had and that we should restore something on this?

(A show of hands.)

CHAIRMAN KASS:  How many think otherwise?

(A show of hands.)

CHAIRMAN KASS:  We will think about it.  I mean, there was a certain — and we will talk to the individuals, but there was a certain sense that these recommendations were to be as much as possible the recommendations that were rested on those things about which we could agree, and part of the thing is to show that people have differences of opinion on some of these matters, and find a basis nevertheless to speak in common on things that are dear to us.

I won't discuss — I think we have noted the people who have reservations about this.  We will pursue that, and if — and we will reach some resolution on that, and you will be informed rather than try to fight it out here.  Is that agreeable?  Janet.

DR. ROWLEY:  It is not on this point, but it is on page 8 and 9.  Are we still on those pages?

CHAIRMAN KASS:  Fine.  Yes, we are still in this section.  I am going to try to budget our time to make sure that we don't lose out on the sections that might take us longer than this.  But, please, Janet.

DR. ROWLEY:  Well, again, in discussions with people more knowledgeable than I, it has been pointed out for Section E, the adjunct technologies, and our concern about ICSI, that in fact about 5 percent of apparently normal sperm failed to fertilize an oocyte.

And at least right now, given the fact that there is no funding to understand these problems, we can't — I mean, the individuals involved in this can't distinguish the normal from those that have various other things that can be identified.

So, you see, we have talked here and commented about the fact that ICSI is used in individuals, even those who do not suffer from male infertility factor, and again with the pressure to have positive results, both from the standpoint of patients for whom this is a painful — or for women for whom this is — the whole process is a painful procedure, they use ICSI to increase the likelihood that you will actually get some embryos from the procedure for the women.

So we are saying that the industry is being irresponsible by using ICSI when they don't need it, but the matter of fact is that you don't know for those who are the 5 percent who they are, and therefore, many clinics in order to make certain that there are some embryos that are developed, do ICSI when it may not be needed.

But, you see, that doesn't come through in the text that is stated here.  So I think that we should be a little bit more — either indicate that there is this 5 percent where it would be unsuccessful, or maybe modify the text here not to be quite so critical as we are of this procedure. 

CHAIRMAN KASS:  If there is an implied criticism, the implication will be removed, and the request is simply for the reporting of the data and the indications, and if there are additional indications, then of course we should note that.  That is a good point, and we will fix that.

Look, I am mindful of the clock, and let me do something slightly out of order.  I suspect that we need more time to discuss Section 3 than Section 2, Section 2 being recommendations to the professional societies and practitioners.

And let me simply go out of order and do Section 2 last to make sure that we don't wind up at 5 minutes to 12:00 with only 20 minutes or so to do Section 3.  So, we will do Section 2 last.

Let's turn to the targeted legislative measures, pages 13 through to the end.  I repeat that these have been pruned, and things that were contested last time have been removed, and certain sorts of other difficulties ironed out. 

And maybe we should keep our attention to the specific proposals first, and worry about the fine tuning of the rationale, and the discussion later.  Page 16, the transfer, proscribe the transfer for — by the way, let me say just — and in this document I apologize, but it doesn't have this point that was made the last time in it.

And these suggested targeted legislative measures were meant to be temporary.  It is indicated in passing that that is the case, but we don't say that there should be a fixed time on it, and that is for review, and that was one of those suggestions made in the Council meeting last time and that will be added to the final version.  So these we are targeted legislative measures of a temporary sort, at least until additional discussion proceeds.

Then to page 16, proscribe the transfer for any purpose of any human embryo into the body of any member of a non- human species, and to prohibit the production of a hybrid human- animal embryo by fertilization of human egg or animal sperm, or an animal egg by human sperm. 

These are the two things that survived.  There were more things in the previous version.  Dissents, objections, comments?  The Dean from Dartmouth.

DR. GAZZANIGA:  Oh, geez.  It is cold up there.

CHAIRMAN KASS:  It is very cold.

DR. GAZZANIGA:  You know, it is all sort of — you know, this flows from the dignity of human procreation and all of that, and I keep thinking of G.K. Chesterton's remark to his son as he went off to college.

He said that with respect to sex, son, it is a ridiculous posture, and I always get confused about where we launch from here.  So if you look at — I mean, what everybody wants is a child out of any deal, right?  A beautiful child.

And that normally occurs in 98 percent of the time through mechanisms that we all know about, and love and respect.  But frequently it occurs through going to a lawyer's office, and figuring out how to pay money to go adopt a child.

And I don't know.  Maybe biomedicine is going to come up with a mechanism where a husband and a wife can fertilize an egg, and the woman can't have it implanted because of certain medical problems, and you can think of a cow as a big tissue culture to allow the baby to grow. 

And what happens is that when the baby is ready for birth the family seizes on the baby with all the love of any parent and life goes on.  So, you know, we take — a lot of these things that have been put in there have been set up with this crazy humanzee notion and that sort of thing.

And really I think, if we start fiddling around with this language, that we may be stumbling upon possible future biomedical advances don't seem very normal after a while. 

So I am concerned with when we start introducing language like the first item there. 

CHAIRMAN KASS:  Comments?  Rebecca.

PROF. DRESSER:  I like the way this is set up because it is a temporary moratorium and it just shifts the burden.  In a sense, it says all right, if you come up with something that seems to be covered by this within the time frame of the operation, then you have to make your case and explain why — you know, certainly it is safe, and needed, and other alternatives don't sufficiently meet the need, and that certainly that practice would be something that ought to be publicly discussed before it went forward.

So I do think that the posture of this, that it sets up, the procedural posture, leaves room for situations where a new technique might develop that does seem to fall under this, and might have a reasonable rationale, and there is still the opportunity to present the case, and certainly the research on that sort of a procedure would probably last longer than these provisions, in terms of effect.

You know, they would go out of operation and then there would be a new discussion about whether a more specific prohibition or provision were needed.  So I think the way that it is constructed, it is sufficient to handle innovations like that, or other things.

CHAIRMAN KASS:  Are there comments on this one?  Janet.

DR. ROWLEY:  Yeah.  I assume in the staff's discussion with representatives of the organizations that have a direct interest in this, and that these were items that did pass their scrutiny and have been retained.

In my discussions with other individuals, they are concerned that it appears to paint the ART community in a less than ethical light by implying that these things are something that the scientists in the ART community are preparing to do, and so we have heard certain discussions about some things that have been done in other countries, but at least as far as those practitioners in the States, they have real concerns about even including these things because in their view this is not something that they are planning to do.

DR. KRAUTHAMMER:  We could take are of that by adding the phrase, "without prejudice" and "without implication," and that would take care of that, I think.

DR. ROWLEY:  But if that is the case, then why do it at all?

DR. KRAUTHAMMER:  Because — not because some people are doing it today, but because it is something that we believe is abhorrent and ought to be at least not permitted until people make the case otherwise.  It seems rather simple.

CHAIRMAN KASS:  In fact, the argument that we — I am not sure, Janet, that it would be fair to say that everything that survives here has passed the scrutiny and claimed the approval of the people with whom we have consulted, that is not our task.

And our task is to learn from them, where we have done things that we ourselves would recognize as unreasonable, or be educated by them about things that would place undue burdens on their practice.

I don't think that there is any implication here that the members of this profession are unethical or unscrupulous.  It is an expression of the community's support at the moment to try to set certain boundaries, and one of the ways in which the professionals could in fact show that they are not under suspicion is to endorse these provisions.

I mean, these are exactly the sorts of things that the responsible practitioners ought to be able to say and be offered — this was a suggestion that we made in conversation with representatives from ASRM.  We have a stake, we would suggest, in making sure that everybody understands that the profession has the highest ethical standards, and doesn't mean to ride roughshod over the boundaries that the community has established.

So we are trying to do those sorts of things for which they might worry about Congress doing anything because they don't like that.  But we have tried to devise those kinds of very modest things that ought to appeal to just about everybody, other than those people who don't give a damn.

So there is no imputation that there is anything irresponsible about practitioners or their society here.  Paul McHugh.

DR. MCHUGH:  Well, I may be saying something at once obvious, but in relationship to this first thing, I have two reasons for wanting to have it included.   One of them is simply the "ugh" factor. 

I don't think that I can speak to the ordinary person in America and say that we think that babies should come from cows very simply, and so therefore the burden would be for the scientists to say that this might be okay.

But I have a more practical concern and reason for wanting to see this.  I believe that it is not outside of anyone's imagination that the process of putting an embryo into an animal to let it proceed for a while would soon become a process searching not for a live baby for these folk looking for a baby, but for ultimately the harvesting of those embryos for their bodily parts; their kidneys, their hearts, and the like.  And I find that repugnant, too.

CHAIRMAN KASS:  Frank, and then Dan. 

PROF. FUKUYAMA:  Well, this just follows on the last couple of comments, and this is actually, Mike, more of a response to your written comments than to what you just said, but I don't think that what you are defending is necessarily the dignity of — you made the comment that human reproduction is not all that different from the mammalian reproduction more generally. 

But I think what is being — you know, you can at least say that each species has its own reproductive rules, and evolution has designed them to be an integrated whole.  So that a baboon presumably will not do very well if implanted, or as a baboon won't do well if put in a human uterus. 

And I would think that there are huge medical risks if you create an embryo that has got, for example, animal — you know, mitochondrial DNA, and if you — and I am sure that there are all sorts of things in the developmental process that go on within a uterus that are specific to a human uterus.

And so again this just reinforces the point that there is a huge burden of proof that needs to be met before you start violating what evolution seems to have designed as this fairly integrated reproductive processes.

CHAIRMAN KASS:  Dan Foster.

DR. FOSTER:  I just want to make a small point in response to Janet's.  I don't know who you have been talking to, but I am not very sympathetic to the view that this might be in some sense a judgment on the ethical procedures.  Let me just turn to the scientific community already, and the protection of human resources.

The scientific community found it extraordinarily abhorrent that some of our greatest universities, and some of our very best genetic people about deaths that have occurred doing things that nobody thought should have been done.

I am not very moved by somebody who is in the ART saying, well, you are impugning our integrity when already we know that in the greatest of our universities, and in the whole scientific community — well, I can't say whole, I don't know that.

But I can tell you that universally condemned — and I not going to mention the names — the things that were done here.  So I don't think we ought to be too worried about somebody's concern about moral things when we know that the very best scientists that we thought — well, I don't want to get started on this, but we need to assume that because we can do certain things that they are going to be done, and not just in rogue private laboratories.  But in the university laboratories of the highest things.

So I am very much in favor of saying let's don't do crazy things.  I mean, I don't know what cow uteruses do, but I know that some people think that prion disease, for example, may in some sense be contagious. We know that cattle carry E. coli, 25% of which are type O157 H7 that may be fatal from HUS ( hemolytic uremic syndrome) from eating insufficiently cooked hamburger. So it is a modest thing to say ' lets don't do crazy things that we can do when we don't need to do them' and I feel pretty strongly about that.

And as I said, I don't want to just hear somebody say, well, we are impugning somebody.  We have to be very careful about what we do.

CHAIRMAN KASS:  Anything further on these?  Do you want to move on?  Let me make a procedural observation, because Mike — and I don't know that you would regard all of these answers as a satisfactory response to you, and I don't want to put you on the spot. 

But I am interested in going through all of the comments, and if there remain — our aspiration was to produce something that we could all agree to, but if it turns out that that can't be done, then we will be left afterwards with trying to sort this out.

And we will figure out a way to handle this either by removal or perhaps by allowing the expression of individual dissent in a very strong way on whatever it is.

This is to take the burden off of Mike from saying here and now, okay, you guys have persuaded me.  I doubt that is the case, and I would like to at least see where we are on some of the rest.  Is that okay, Mike? 

DR. GAZZANIGA:  That is very kind of you, Leon, and you are exactly right.

CHAIRMAN KASS:  Okay.  Let's move to the second.  This language has been changed to make it unambiguous; to prohibit the transfer of a human embryo produced ex vivo to a woman's uterus for any purpose other than to attempt to produce a live- born child. 

And the grounds of this have been laid out in the paragraph before, but what we are concerned about is the correlate to the previous one.  If human embryos go anywhere, they go into human uteruses, and if they go into uteruses, they go into human uteruses, and what goes into a human uterus goes only for the purpose of producing or trying to produce a child. 

This I think the last time around had not even a whimper of dissent.   Are we all right? 

DR. ROWLEY:  Just as a point of clarification, I assume that this language doesn't really prohibit the use of PGD to select for an embryo that might be appropriate for some other purpose, because that embryo is selected in general to go to full- term.  So that is not covered in this.

CHAIRMAN KASS:  This solely has to do with for what purpose may you — the previous language was to initiate a pregnancy, and that was found to be — it was obscure and it raised all kinds of worries that were unnecessary, and so this is in effect to start a pregnancy by the transfer of a human embryo conceived or produced ex vivo for any purpose other than to yield a child. 

It says nothing about what is done with embryos outside that don't get transferred. 

DR. ROWLEY:  Or before the selection of the embryo being transferred.

CHAIRMAN KASS:  It says nothing about that at all.  This next provision was one that caused a lot of trouble, but I think we have found with one exception, and I can call attention to the problem in the language now, but the one about children.

I think we have found a way to express this that was satisfactory to the vocal disputants of the last occasion, with the important exception that the presence of the word "and" on the top of page 18 seems to imply that in order for something to be ruled out it has to be guilty of all of those three things.  That doesn't really make sense.  I think the language should be "or" and the reason that we have listed it this way is so that the footnote could operationally define in one footnote exactly what it is that is meant. 

Prohibitive attempts to conceive a child, footnote, and by definition that means to create ex vivo an embryo of this sort with the intent to transfer to a woman's body to initiate a pregnancy.  Prohibit attempts to conceive a child by any means other than the union of egg and sperm by using gametes obtained from a human fetus, or derived from human embryonic stem cells, or by fusing blastomers from two or more embryos.  These were under discussion the last time.  Michael.

PROF. SANDEL:  Well, I think removing the "and" so that it is clear that we are not asking Congress to prohibit some bizarre compound activity that would never arise is a good thing.

But I am not sure that "or" removes the ambiguity altogether, because it could be read as proposing that Congress prohibit one or another of these three things.

So what I would urge is that we remove the ambiguity by simply adopting and by repeating the verb clause for each of the three bullet points as we have done with all of the others, this may seem like a semantic distinction, but I think that it is important for reasons that we could pursue, and that came up last time, but simply say prohibit attempts to conceive a child by any means other than the union of egg and sperm, with the asterisk and the footnote.

And then repeat that phrase in each of the two other proposed prohibited activities with the same asterisk and with the same footnote. 

CHAIRMAN KASS:  I don't see any problem with doing that.  We were — quite frankly, this was one of these places where footnoting and simply the questions of the mechanics of getting footnotes on the page, and repeating footnotes, suddenly produced a way that you could probably do this with one footnote, and the thing was restructured. 

But we are perfectly happy to restore the less ambiguous way and have the same footnote referred to three times or have it three separate times.  It is not a problem.  Are we okay on this?  Difficulties?

(No response.)

CHAIRMAN KASS:  We come to the fourth set of recommendations, pages 18 and 19, and here once again this may be contested.  This recommendation, these recommendations, do not say anything about the licitness or illicitness of embryo research as such.  But even the people who would be or who would prefer that there be no embryo experimentation, but recognizing that it goes on, are willing to join with others.

In fact, the minority position in the cloning report did call for regulation of this, and setting an upper boundary, that there should be some kind of upper limit on the age of embryos available for research, at least at the present time.

And that this is an attempt to suggest the prohibition of the use or preservation of those embryos that are already being used solely for the purposes of research beyond a designated stage of embryonic development, and we left it to the Congress to find its date.

We suggested the range, and then as a result of a long discussion the last time, and what was left of the commercial matter was to prohibit the buying and selling of human embryos.  The gametes part of that as you will recall was in there last time and is not at the present time. 

DR. KRAUTHAMMER:  Leon, I think that I might want to include the range that we have considered, the 10 to 14 days, in the body of it. 

CHAIRMAN KASS:  In the body of the recommendation?

DR. KRAUTHAMMER:  Yes.  I am a little wary about leaving it entirely up on the air, because it would allow — I mean, if we are assuming that this will go to Congress, and there might be pressure to allow higher upper limits, and I think most of us, or I think all of us would agree that the upper limit ought to be within this range.

And I think it would be helpful to Congress to have that as a guideline.

CHAIRMAN KASS:  As a guide posture, yes.  Any objections if we put that into the text?  I mean, they are obviously free to ignore all of this, or free to ignore that, and once again this is for the time being recommendation, and even our representatives from BIO said that they would for the time being favor such an upper limit if I am not mis- remembering that conversation.

We might even have a fair amount of public support on this as well.  Are there any objections on any of this?

(No response.)

CHAIRMAN KASS:  We are left with the patenting matter, and I think that people probably know that — if I can get my cheat sheet here, that the House — that this recommendation might be rendered moot by developments in the current session of Congress.  The House of Representatives has included an amendment to the Commerce, Justice, State Appropriations Bill for Fiscal Year 2004 that would preclude the Patent Office from issuing a patent, "On claims directed to or encompassing a human organism."

And the Patent Office has supported this amendment, and the House — the Senate and House conferees have agreed to include this amendment with some explanatory language in the final version of the bill, but the Senate has yet to vote on the bill, but may do so as early as next week.

If that in fact happens, we can simply delete this provision as being rendered moot.  Michael.

PROF. SANDEL:  Is there any good reason that we have for using the word, the phrase, human embryos or fetuses, instead of the word that is in the legislation that you just read, human organism?

CHAIRMAN KASS:  I see no reason not to even prefer it; to encompassing human organisms at any stage of development I think would be —

PROF. MEILAENDER:  I don't see any reason not to prefer it.  I think the reason that it is here is that it came immediately under the section on respect for early stages of human life. 

And that is probably the reason, and it would need to be clear that it was not a part of that section if the language were changed. 

DR. KRAUTHAMMER:  What does organism add that embryo or fetus would not?  I mean, what are we losing by using embryo and fetus?

PROF. SANDEL:  I don't know the legislative history that led them to adopt organism.  I would be interested to know and to consider that before we decide what language makes the most sense to us.

CHAIRMAN KASS:  Charles.

DR. KRAUTHAMMER:  If it is a question of just matching the language, then I have no objection.  I was just wondering whether there is a substantive difference.  I don't really see any other than organism might mean a full human, which would be an anti- slavery provision, which would be nice, but it is 160 years a little bit late.

So I had no objection if it is just a matter of procedure, but I would be interested if there is an actual difference here. 

CHAIRMAN KASS:  Carter, please. 

MR. SNEAD:  I was just going to add a point of information on the legislative history to speak to the evolution of the language in that particular provision.

In the version that has been tentatively approved by the conferees, they have included in the language now — they have agreed in principle to include language, a colloquy between two members of the House of Representatives to clarify, because there was some question about what the word organism referred to, they have now included a colloquy and some explanatory language from the manager's statement that clarifies that they are referring to embryos, fetuses, and so on, and so forth. 

So this, just by way of explaining or responding to your curiosity about the legislative history.

DR. FOSTER:  My question is —

CHAIRMAN KASS:  Carter go ahead.

DR. FOSTER:  Well, I have not heard about this, but does this imply — does this affect things like genes from humans and so forth and have they been patented?

MR. SNEAD:  No. The explanatory language in the amendment is very similar to the explanatory language in our statement here, wherein we say that the language of any such statute would need to take some care not to exclude from patentability certain things, the likes of which you have described.

And the explanatory language in the manager's statement does precisely the same thing.  It says this is not meant to exclude patents on even stem cell lines and gene sequences, and so forth. 

PROF. SANDEL:  Do we know why they changed it, the language in the law, from embryos to organisms?

MR. SNEAD:  My understanding of the evolution of the current language is that Representative Weldon from Florida included this language that was quoted by Leon. 

When it got to the conference there was some negotiation of some possible addenda to further explain what the language means, and the result, which has not been agreed to formally, but has been agreed to in principle, is to include explanatory language.  So they began with organism, and now they have added this explanatory language, and there was some negotiation about what that language meant. 

PROF. SANDEL:  Would it be possible for us to get copies of that legislative record that we could — in case there are reasons that have not occurred to us about the significance of the choice of the term organism?

CHAIRMAN KASS:  We will be glad to do that, and in fact I was going to recommend that we do that and study this matter before agreeing to the final language, if indeed if has not been rendered moot as a result. 

MR. SNEAD:  Just a last — I'm sorry to keep interrupting, but the last point of clarification is that this is in the context of an appropriations bill also, and the precise language speaks to allocation of funds for the issuance of patents on certain things. 

CHAIRMAN KASS:  I see.

MR. SNEAD:  It is not merely a statute that proclaims these provisions.

CHAIRMAN KASS:  So this is a rider on an appropriations bill and lasts just as long as that bill?

MR. SNEAD:  That's exactly right, and in that way it is similar to the Dickey Amendment.

CHAIRMAN KASS:  Then we are it seems to me still in business here on this, regardless.  Was there someone with a hand that I failed to recognize here?  We will get this information and study the matter, and we will advise you as to what we have learned, and then reformulate exactly.

Am I right in saying that with the exception of Mike and his concerns which may extend not only to the comment that he made, that the rest of us are all right with the formulations that are here, and that there is certain language to be cleaned up.

We want your line edits on the rationale and justification.  We will take the changes in the third point as Michael suggested, and we will do what we need to do to clarify this last point on the patent thing.

Let's go back and look at the recommendations addressed to the professional societies, and practitioners.  Suggestions to improve informed decision making, and encouragement to treat the children who are the products of ART as relevant patients.

Some encouragement to improve the enforcement of their own existing guidelines, and improve procedures for the movement of experimental procedures into the clinical practice, and to create and enforce minimum uniform standards for the protection of human subjects and the invitation that they join the kind of activity we are engaged in here as setting thereforth their own self- imposed ethical boundaries in the name of their own professions. 

These are the things that we think all people who are members of our society shouldn't mind, though.  Obviously, we have discussed these things, and I think that some of these things will probably simply be welcome. 

They are mostly hortatory, and we would like to think that they would receive serious consideration.  We have every reason to think that they would be considered seriously even if there is disagreement.

And I myself don't see any reason why we shouldn't at least suggest these things for their consideration.  But I think that this was the sense of the group the last time.  Some of these items may strike you as not warranting inclusion, which is why we brought them before you again. 

Comments or questions on any of these items?  Janet.

DR. ROWLEY:  Well, in line with my earlier comments, and so I recognize what Dan is saying, I think that we should be more cognizant of the fact that most of the physicians and scientists working in ART are in fact committed to ethical practices, and are responsible individuals.

And so I would like to see the preamble to this section at least include a sentence that we recognize that they are individuals who have the health and well- being of the woman, as well as the child, as a high concern, and I think that that should be stated.

It has been suggested to me that under Item A, improved informed decision making, that in fact the standardized forms for consent, et cetera, may be difficult to develop because there are certain State laws that are different amongst the States, and therefore trying to resolve the differences might cause problems.

And Rebecca or somebody would know better than I whether there are really such State laws that might make a uniform consent form impractical.

CHAIRMAN KASS:  Rebecca, please.

PROF. DRESSER:  One thing to do would be to — I think at one point it said model.  Basically, I think the idea here is that there should be a basic set of substantive information that is provided to all prospective patients, and then clinics — there will be information that should vary from setting to setting, just because of various features of the clinic, and so forth.

So I don't think this is saying that there is one form for everyone, but that the basics would be there, and then it could be tailored to the specific setting.

And I am not aware of any — I mean, there may be some laws setting forth something like, well, perspective patients should be told the success rates, or something like that. 

But I don't think that there are any laws that would conflict with laws in other States.  So I don't think it is a serious problem. 

CHAIRMAN KASS:  Also, I think one could say that at least one of the patient groups that we have spoken to is quite interested in this thing.  I think more could be done here to get this information out.

So it is not just giving consent, but it really is to make the decision making more informed, and we have been guided in part by Rebecca, and in part by requests from some of the patient groups that we have spoken with on this point.  Mike, please.

DR. GAZZANIGA:   Paul, help me with this.  Let's say on page 11 that we were going after psychiatry, and the first sentence would read, "The psychiatrist should take measures to ensure the health and safety of all participants after they leave the psychiatrist's care and his building."

I mean, isn't this sort of a harsh way to introduce the notion that maybe the ART physician is raising somewhere?  All you are pushing here for is that we would like some epidemiology to make sure that — well, I don't get the harshness of this paragraph, and I would just think that — and I am trying to imagine a physician being told, lectured to, about how they might not be caring correctly for the medical procedures that they administer.

DR. MCHUGH:  Well, it is interesting that you mention psychiatry, and the long term effects, and effects of other people that are involved in the enterprise, because there are laws as you know in the State that — in all the States now, that if a psychiatrist in caring for one patient discovers that that patient might be a danger, or a serious danger to some other patient, or some other person, that it is intended upon that to break the confidence of this procedure, and they are told in no uncertain terms in the courts that they will be held responsible for any damage that could be done to that third- party.

So to some extent, Mike, that kind of harsh language for psychiatrists in particular is already on the books. 

CHAIRMAN KASS:  Let me also — sorry.  Let me respond to the specific content here, and if the language seems accusatory, we will change it.  What is behind this is this. 

And this came out in the conversation with Sandy Carson and Sean Tipton, that for the most part the people who practice ART, the clinicians, regard their patients as the infertile individuals as patients.

But what is recognized clearly is that — and in fact that is one of the concerns that animates this entire report, an interest in the children who are produced, and who are not yet there. 

And yet those children are affected by the things co- incident with their conception.  And the question is whose responsibility is it to start to pay attention to those things. 

Very interestingly, after Sandy Carson made her own presentation here, she reported that the society was beginning to produce new collaborations with the Association of Pediatricians, and that the concern for the children produced by these procedures was now increasingly part of their own concern.

Up until this point, they have said quite frankly that our clients are the infertile couple, and somebody else looks after the children.  But this is one of those areas in medicine where in fact the treatment of these individuals means the production of another individual who is joyously present, but nevertheless somehow at risk, and one wants to somehow address the concern for those participants who have so far not been considered part of the domain of concern.

How to do this given that the reproductive endocrinologists are not going to care for the woman through her pregnancy, and are certainly not going to look after the child is a difficult matter, but we have at least encouraged the society to think about that individual who is in fact one of the participants, though he or she is not yet spoken up.  Bill May.

DR. MAY:  It seems to me that there have been two points made.  One is the question of whether if you offer comments by way of encouragements to professional society, you are tainting and offering accusatory judgment against them, and it seems to me that Charles' point that in fact your concern was protecting that community, and not simply tainting them by the development of advisory here.

But, second, there is an additional problem of disaggregation of services in health care.  So it is not simply a question of use- abuse, and to worry about abuses. 

The problem with the disaggregation of health services is a general problem, which is more acute here, because you have got the services of somebody assisting in reproduction, and then you punt on to somebody else.

And it is compensating for this general problem in our health care system by suggesting that those who offer one service ought to have sympathy to the problem of continuity in health care, which in this case includes a new human being. 

And so it is not simply charging against abuse, but enlarging the sense of responsibility as it bears on a general problem, which our health care system faces in the balkanization of services.

CHAIRMAN KASS:  That is a very nice point, Bill, and I think the rationale for discussing this could certainly include those points.  Dan.

DR. FOSTER:  In the first place, I want to agree that we ought to get the harsh things out, and I certainly — and maybe in your sentence we ought to say that we know that the vast majority of all physicians in ART are highly ethical and so forth, and I think we ought to use vast, and this is not an attack on anybody.

But here — well, I am puzzled, along with Bill May.  I mean, medicine is a continuity, and we do pass on.  I mean, when you have your coronary bypass surgery, then it goes on to the cardiologist.  And the bypass surgeon is not — I mean, he cares about the patient, and wants to be informed about the patient, but I really don't see what the person, the physician who is inducing the pregnancy, what that person can do once the pregnancy has started, or if the child becomes born, and the pediatricians, and then the obstetrician passes it on.

And then when you are 16 or 17 years old, then the pediatrician passes the patient to the internist, or whatever.  I mean, I really don't — I have been troubled about what we are trying to accomplish here.  I mean, in there, and I think it would — I guess you could say that you can improve communication and let the obstetrician know if there are complications leading to abortion and so forth, so that there is new information.

But I don't see — and then you could say that the internist passes it on to the geriatrician when somebody gets to be 65 or something.  I mean, medicine is a continuity, but it is also in practice a discontinuity, and I don't see how what we are saying to the ART people that they have a responsibility once they have done their duty and done their work.

I mean, I think this is — and it may be a little bit superfluous to it, but —

CHAIRMAN KASS:  Let me try, Dan, if I might.  I mean, I take your point.  I think that the reason that this comes up at all is to repeat this is a peculiar branch of medicine because the treatment involves the creation of a new individual.

When we get passed from our cardiologist to our urologist, to our internists, it is the same person who goes along.  Here what is being passed on, though invisible, is a being who is both the product, but also the patient, of this procedure, and we don't want to somehow say, or at least at the moment no one is going to say that when you ask, well, the ethics of experimentation, or the ethics of practice in the ART clinic somehow has to take into account the rights of the embryos that are created.  That is not going to pass.

But it is sort of odd to say, to hear people say, that all of the participants in ART are the doctor, the man, the sperm donor, the egg donor, and the woman who carries the child. 

There is another being that is being produced here, and becomes eventually a being, or whatever it is.  And to begin to think about one's activity, mindful of the presence of that eventually to be produced being I think affects also how you practice.  It means that you begin to cooperate in the longitudinal studies on the well being of those children, and it means that you think about, for example, the effect of multiple embryo transfers.

And you think not just about increasing the chances that your clients are going to have a baby, but you think also about the effects on the children who are going to be born from being one of a number of multitudes once one knows that there are huge health risks associated with multiples.

And we are not telling anybody what to do exactly, but to say enlarge the purview of who you think your patients are when you think about what standard ordinary practice is in this field.

And I think that there is some indication that — and maybe one should say this — that the society by itself increasingly recognizes this, especially if we take what looks like accusatory language out that they would find anything to dissent from here, though that they might be willing indeed to enter more closely into follow- up studies with the pediatricians, because they have an interest in what the effects are of the procedures that they are using on the children who come to be born. 

That, I think, would be the justification for singling this out for special attention.

DR. FOSTER:  Well, okay.  I mean, I understand what you are saying, and you are saying that the primary emphasis of the discipline is to get a baby, and what you want to say is that it is not only to improve the parent's hope of getting a baby, but that what is being produced ought to be done in the safest way, and that is why we are going to try to get the information.

And let's say if you try to take a cell out of a blastocyst, you know, does that mess up something in the future, and that is information that would be there. 

But when you read this, it sort of is like saying to participate with the pediatricians and so forth, and it sort of moves beyond into this discontinuity, and that is what is bothering me.

It seems to me that the emphasis of saying that we need to pay special care to improve our concern for the product of this is really part of what they do, and is implicit in what they do, that we have to try to get that information.

But I don't see how — the only thing that I don't see, it does kind of — you know, when you say should collaborate with pediatricians in making decisions, or obstetricians for that matter that might affect the health and safety of these children.

Well, once the conception is there, then that becomes the business of the obstetrician, and then subsequently — and what I am concerned about is that it looks like their assignment is to act clinically when it is beyond the realm of what they do.

CHAIRMAN KASS:  That is a point well taken.  Absolutely well taken, and we will fix that.  We will try to make this say what we intend and no more, and not to proscribe.  Mike, please.

DR. GAZZANIGA:  Just a sentence on E that I will just mention, and we can sort it out later.  The sentence, "This problem is compounded by the fact that there is not a clear distinction between research and innovative clinical practice in the context of ART."

You can say that in the context of all medicine.  There is always little diddling at the edges and clinicians change the application of the medication, or surgery, and then it becomes a hypothesis, and then it becomes a clinical trial.

And that just goes on, whether you like it or not, and I just think that to — I mean, you may be of the opinion that shouldn't go on in ART, but that is kind of how medicine works, and I just think it sticks out as kind of naive. 

CHAIRMAN KASS:  Mary Ann.

PROF. GLENDON:  I share the concern about accusatory language, but I hope that that concern isn't going to be translated into playing down the fact that after hearing many people on this issue that we have uncovered serious concerns about informed decision making, and about protection of women and children.  And I hope, too, that in this report concentrating on self- regulation by the profession on the one hand, and legislative regulation potentially on the other hand, or legislative measures I should say on the other hand, that we do not overlook the most important stakeholder if you want to use that word, which is the public. 

One of the things that we have learned is that the public, like ourselves before we got educated on this, is lacking essential information about these procedures.

And one of our charges as a bioethics Council is to raise the level of the public discussion to ensure full public deliberation of these issues, and the public cannot deliberate without information.

So there is yet another stakeholder and another reason for having the best possible information about these procedures. 

CHAIRMAN KASS:  Frank. 

PROF. FUKUYAMA:  Is it okay to make a general comment and not on —

CHAIRMAN KASS:  Please.

PROF. FUKUYAMA:  I think the public as a stakeholder is right, but I again think that the industry itself has really got to think carefully about its own self- interests in this entire area. 

There is this cautionary tale unfolding in another area, which is Mad Cow Disease.  If you look back at the entire European opposition to genetically modified foods, a lot of Americans tend to think that this is all completely irrational, and it has to do with the European protectionism and love of regulation, and so on and so forth.

I think that if you look at historically how this came about, it was as the result of a regulatory failure.  That is to say, that Europeans didn't actually regulate for environmental purposes more heavily than the United States in the 1970s, and they actually regulated more lightly.

There are irrational aspects to the European opposition to biotechnology, but the single thing that drove this entire catastrophe for the agricultural biotech industry there was the regulatory failure, and how the British food safety regulators responded to the initial outbreak of BSE. 

They reassured everybody that it was safe, and the result was that they were proven wrong, and people reacted perfectly rationally to this information about their own regulators. 

And that they had either been captured by the industry, or that they weren't competent to do their job and so forth.  So now you have a lot of consequences, not just heavier regulation of beef throughout Europe, but it has had these spill- over effects to the opposition to genetically modified foods across the board.

And, you know, I have this sinking feeling when you watch the American beef industry respond to the current Mad Cow problem that the beef industry did, and they say, well, we are regulating ourselves, and it should be sufficient, and they are just setting themselves up, and I have no idea how many cases of mad cow disease there are out there right now.

But there is a really big danger that industry, in taking this very light regulatory approach, and so I would think that the big stakeholders, the industry itself, has got to think really carefully about those precedents and its own self- interests.

You don't want to set up a case where a rogue practitioner does something that produces a very disproportionate political backlash.  And all of the big failures in the last few decades have been from industries that were too lightly regulated.

You know, accounting, energy transmission.  I mean, we have seen a lot of cases of this where the industry participants said look, we're taking care of it, and we have our own best interests at heart, and so on and so forth.  And it proved not to be the case.

CHAIRMAN KASS:  Any final comments?  Well, I think we have done very well.  I think we are fairly close.  We see places where the text has to be fixed, and there are some points still in contention about the restoration of a missing paragraph on keeping track of the counts of embryos.

We have conversations to have with at least one of our members, and line editing suggestions can come in when the new document as a whole comes to you, which we hope will be within the next week or two.

And there will be plenty of time for a thorough review.  We will review as we did with the stem cell 3 weeks for review, and we will receive the comments, and you will get the responses to all of your comments, and if all goes well, the target date for this would be the April meeting to be released.

And I don't see any reason given what I have seen why we can't make that deadline.  We are right on time.  At two o'clock this afternoon, we have two invited guests to introduce us to the wonderful field of neuroscience and neuropsychiatry, Robert Michels, and Jonathan Cohen.

I think they will probably both be here in time for the first session, but let's be sure that all of you are.  Two o'clock in this room, and the meeting is adjourned for lunch.

          (Whereupon, at 12:15 p.m., a luncheon recess was taken.)



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