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Friday, July 25, 2003

Session 5: Biotechnology & Public Policy:
Discussion of Findings and Identification of Policy Options


CHAIRMAN KASS:  Good morning.  Thank you all for your endurance yesterday. 

It was a very rich session and much to digest, and the conversation on the stem cell monitoring will continue in the September meeting.  We know already that Dr. Zerhouni will be with us to talk about the implementation of policy and give us an update on what's actually happening out of the NIH.  We're looking forward to that.

In this session this morning, "Biotechnology and Public Policy:  the Discussion of Findings and the Identification of Policy Options," we will be dealing with the two staff working papers that have been presented in your briefing book.

The first of these papers on findings contains findings that are distilled from the diagnostic document that was discussed at the June meeting, and the second, some policy options, a paper prepared in response to the council's request that lay out some general options both for general institutional reform, as well as for certain specific areas of concern, the latter derived really from and in relation to the specific findings.

And the goal for this session is threefold.  The first two, most important: 

First, to move toward agreement regarding what we have found in our diagnostic survey.  That will be roughly the first half of this session;

Second, to move toward clarifying some of the relevant policy options open for public discussion in the areas identified in the findings;

And, third, looking toward a subsequent meeting to begin to see if there are areas of common ground regarding some of those policy options that this Council might be prepared to recommend in the interim, while the longer conversation proceeds.

Our intention at the moment, subject to your approval and review, is to issue some kind of document some time in the fall, the major part of which will be diagnostic, and laying out certain of the possible policy options for the public to continue to consider.  And if there are places where we can agree on specific recommendations, we will do so even if it's limited simply to the matter of the need for more information, review, and monitoring in selected areas.

I should say you have at your place a printout from the Web edition of the morning Washington Post, where unsolicited we have editorial support for our activity, unheard of in the newspapers with respect to the workings of this Council.  Please read it at your leisure.

Before we start the discussion, I'd like to introduce one new member of the staff, Adam Schulman.

Adam, would you stand?

Adam is a tutor at St. John's College and is working as a consultant on the Beyond Therapy project for this summer, helping to get that into shape.

So the first part of the meeting on the findings paper.  I remind you that these findings are an attempt to distill the outcome of the diagnostic inquiry.  To make it perfectly clear as the document itself says, the listing of the findings is not intended to imply anything in particular, indeed, anything at all that would require public policy response.

And please note the place of ART in this document.  This has been stressed several times, and the purpose of this inquiry is not retrospective effort to regulate ART.  We've taken that up because it is the gateway technology  and the advent of new genetic screening possibilities and the like; build upon that, find their home in that context.

And therefore, thinking about monitoring reprogenetics begins really with thinking about the monitoring of this area of work.

I think we should probably go through the findings in toto and then one by one, as you would like.  This is not the place to do the line editing.  We want your comments on that when you go home, but the basic question is:  are these basically accurate findings?  And is there anything of importance that we have omitted?

And let me get some general comments, and then we can go slowly one by one.  And there are some people with special interests in these regulatory activities, and perhaps if I have no volunteers, I'll just call on you:  Frank, Rebecca, Jim, Mary Ann.

Rebecca, do you want to start?

PROF. DRESSER:  Okay.  I passed on most of these comments already, but let me say them for the group.

One overall reaction I had was that many of the problems, the findings described in the document could be applied to other areas of medicine, and so I guess I see two broad questions.  One is in what areas has this branch of medicine and innovative practice had less oversight than other areas of medicine and, you know, what problems does that create?

And then the second broad point would be:  are there reasons why this area of medicine should have greater oversight than other areas of medicine?  And if that's an argument, then what are the reasons why this particular area of medicine needs more federal oversight, that sort of issue?

So that was a basic question I had.  I do think the fact that many of these innovations have not received oversight for safety and efficacy in the same way that drugs and devices do is an example of where this has not received the same amount of regulation as other innovations.

Now, one of the reasons is that they often involve procedures, and procedures aren't regulated by the FDA.  So in some ways that's similar to surgery, but I guess I think that we should remember that there's a baseline of sort of standard practice of medicine and how the government looks at that practice and then remember that this is a component of that in terms of asking what kinds of oversight it ought to have.

CHAIRMAN KASS:  Thank you.

Frank, do you have?

PROF. FUKUYAMA:  Well, I think the summary is quite good, and it does point to a lot of the conclusions that came out of the last staff paper.

I guess there are a couple of things that we would need to talk about a little bit further about why we're interested in this, which in a way was addressed yesterday in the short exchange between Jane and John Gearhart, and in a way the Post editorial states it a little bit better than the staff paper, which is to say if the concern is simply with the safety of existing IVF procedures, I think you need to really make a case that the current levels of safety — I mean, even if some of the statistics that were shown to us yesterday were true, you know, that IVF produces twice the level of birth defects, you know, of natural births, I mean, you don't know what the baseline is.  I mean, is that high or low, or is that something to really worry about?  Is that something that can simply be dealt with with informed consent?

And, you know, those are serious concerns, but it's not clear to me that that's sufficient to drive, you know, a major effort to, you know, talk about regulation in this area.

And I think that somehow it ought to be clear that the kinds of concerns that ought to be driving us are certain possibilities for reproductive medicine that are not germ-line, you know, that are not ten, 15, 50 years down the road, but, you know, possibilities that are actually fairly realistic that either can be done today or will be possible within the next few years.

I mean, for example, if you could take a stem cell and walk it back and produce an oocyte, you know, from a male, you know, a stem cell coming from a male so that a man could, in effect, you know, become a mother, I mean, do we say, "Okay.  Go ahead.  Do it, you know, if you want to"?  I mean, is this something that the society feels comfortable simply permitting to happen?

And that's the kind of possibility that I think does trouble people.  I mean, the Post editorial talks about a lot of those things that came up at this conference, and we need an evaluation, you know, also about what is going on in this area and how much of this really is, you know, near term and how realistic some of these possibilities are.

I think that that would probably help in setting the context for why we're interested in doing this.

As I mentioned yesterday during the last presentation, I actually think that there's still a lot more factual information that we need to collect on all of these topics.  For example, this question of the FDA's authority to regulate the practice of medicine, as I understand it, I mean, I'm not a lawyer, and so I just have to believe what I'm told by other lawyers, but I am told that actually if the FDA were sufficiently creative, its clear authority over medical products would give it a gateway into actually controlling quite a few procedures because there aren't any practices that don't involve, you know, products, medical products.

And you can interpret the authority of the agency, you know, in certain ways that would give you that authority, and again, they just have chosen for prudential, kind of political reasons not to exert it.

There's a lot of interesting things that have been going on.  For example, we were told that the FDA should have used the Administrative Procedures Act when it asserted its new authority over cloning, but instead used "The Diane Rehm Show."  That, in fact, may be quite a clever political strategy on their part knowing the problems of going through the APA.  You know, if you want to informally assert your authority, this may actually be a good way of doing it.

So there are a lot of mysteries really, I think, still of a factual nature about what powers the government currently has to deal with a lot of these sorts of issues, and I'll reemphasize something I said at the last meeting.  I really hope we don't get too driven by the timetable of, you know, the fact that our mandate only goes through November.  I really hope the mandate gets extended, and I hope that, you know, if we can get an early decision on whether the Council's work is going to continue for a few more months, that would be very helpful for this particular project because I do think that, you know, serious consideration of these issues really is going to require a lot more work on the part of the staff and Council members and so forth.

CHAIRMAN KASS:  Thank you.

Mary Ann.

PROF. GLENDON:  Yes.  I, too, think the findings are accurate and helpful, and I think it's worth remembering that just as many of these findings came as a surprise to all of us who have a certain expertise in the field, they involve matters that most members of the public are unaware of.

Most people, in spite of the fact that we live in a society that in some sense is committed against heavy governmental intrusion, most people think that somewhere there is somebody who is paying attention to their health and safety.  It comes as a surprise to find out how much is unrelated.

And, Rebecca, I'm sure that's true in other areas besides the one that we're studying, but this is the one that we're studying, and I'd just like to illustrate this point with an anecdote about a woman who came up to me.  She was sitting at one of our hearings, at our last meeting.  She came up to me afterward, and it was after I had asked a question of a provider of assisted reproductive technologies.  I said, "What do you say in your interview with the woman who comes to you?"

And she said that she and two of her friends had been in IVF programs, and that no one had ever spoken to them about the risks involved, the likelihood of success.  The interview consisted of, "you really want to have a child."

And I think the assumption, the background assumption, of a lot of these people is that somewhere somebody is looking out for me.  Somewhere there are governmental agencies that do keep an eye on things.

So I think just on this part, this staff working paper, the part about findings, it's very important just to do what our mandate tells us we're supposed to be doing, and that is raise the level of public awareness and deliberation.

CHAIRMAN KASS:  Jim Wilson, do you have something on this?

PROF. WILSON:  I did not have anything to say, but I will try to invent something in response to your request.

(Laughter.)

PROF. WILSON:  I feel very much as Frank and Mary Ann feel.  To me the most interesting part of this is the distinction we have to keep in mind between regulation and monitoring.  I do not have an ideological objection to regulation properly designed and properly applied, but I'd like to know the factual world to which it is applied before it is applied so that we can form some sense of the costs and benefits of various regulatory schemes.

And the lack of monitoring, the lack of carefully done longitudinal studies that follow children having gone through various procedures to me is quite disturbing.  I'm sure in other parts of medicine we may find that, although the various parts I know something about, largely having been a patient rather than a practitioner, is that there's a keen attention to what happens from longitudinal studies, and good doctors, which are not all doctors, take into account these findings in explaining the costs and benefits of different courses of action when you confront them, and that's highly desirable.

So that before I would want to design a regulatory structure, I would like to encourage very firmly the use of monitoring studies to follow people from ART, particularly those using ICSI and PGD and the newer technologies so that we can find out what happens to children.

And the argument for doing this firmly, as opposed to doing it in other fields of medicine, is that we are talking about the lives of babies, and we have a special obligation to figure out what the costs and benefits of these procedures are.

CHAIRMAN KASS:  Thank you.

Janet Rowley.

DR. ROWLEY:  Well, I have a number of comments about the paper.  I think that it certainly does reflect the areas in which we've been discussing quite effectively.  I think it's quite helpful to look at each one of these subsets and then try to figure out why is there no uniform or comprehensive data collection.

And as I pointed out yesterday, this is a very costly matter.  So the lack of data are direct results of the fact that there is no funding for this area of research, and I think that that actually has an influence on many of the other areas that are included within this staff document.

Looking at technologies and trying to improve them, following up on what Rebecca said, if you're going to, say, look at a series of techniques, trying to see which one is the best, this involves experimenting on embryos to see which one leads to, from whatever measures one can use, the best growth or you can't go and do these experiments in patients, which is what you would do in other scientific matters, because you can't just give five patients embryos treated this way and five that way and see which is best and then move forward.

So this is a very difficult area, but we give it no money at all.  So how can you express progress in some of these?

And the same, the concern about the fact that these techniques are not tried, say, on primates.  Primate research is exorbitantly expensive, and there's nobody to pay for it.  So we are the victims of decisions made years ago not to fund this research.

There's another area that was touched on yesterday, which I think is something that we should try to help at least bring to the attention of Congress, and that is the inequality of access to these technologies because poor black couples who might want to have a child, unless it's in a state where there is coverage for this, have to pay for this themselves, and this is thirty to fifty thousand dollars, and they don't have this kind of money.

So our health care system mitigates against wider use of this.  Our health care system also encourages the implantation of multiple embryos, which everyone agrees is a bad thing both for the embryos and for the mother, because of the way we finance health care.

So I think it's important that we not get into the mindset that it's the practitioners of ART who are doing all of these things which we find less than ideal and somehow they're doing things less ethically without looking at the causes of some of these.  And I think that that's extremely critical.

And I want to just close with pointing up Rebecca's first comment, that there's less oversight, and I'm not sure that that's so, of this area of medicine than others because who's looking at how you're doing appendectomies and who's looking at how you're treating diabetics?

There are general practices, but I'm not sure that we have complete databases on that, but then the question also is does it merit it, and some of what Frank said, it says that this is a unique area, and therefore, it merits some kind of consideration.  And one of the questions is what kind of consideration, oversight, to use Jim's words, monitoring does it require.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  Just to respond, when I said less oversight, I meant that innovations do not go through the FDA regulatory process.  Now, other procedures, in surgery, appendectomies, they don't either, but a new drug for diabetes has to go through the FDA, and it has to be tested, and all of the studies have to go through IRBs.  And so I do think there is differential treatment there.

Just a couple other points to throw out, the barriers to funding in this area put in place by the congressional ban on funding destructive embryo research would prohibit federal funding for some research that you might like to do to demonstrate safety in this area, but I don't think it would prohibit, say, a longitudinal study following children who were born from IVF.

Now, I don't know if there has been a policy decision at NIH not to fund that kind of study or if there's some other agency problem with that, but I don't think the statute itself would apply to all research that we would talk about here.

So just a couple of points.

DR. ROWLEY:  Well, it's my impression the CDC is empowered to do something, but I don't know exactly the scope of that and the time frame of that, and you can say they're an appropriate agency to undertake this because they're involved in other studies in epidemiology, though the subject matter of this is a little different than they've been involved in before, but it would certainly be helpful to know what the mandate of the CDC is or how they're proceeding and what questions they're asking.

Because we've pointed out there are a number of questions they may not be asking which we think would be very essential to gather necessary data.

CHAIRMAN KASS:  On that point, Janet, I think in the diagnostic document we did list what the federal statute requires the CDC to do in this area, and in the policy options, there is some identification of the kinds of things that might be added if we were so inclined, but we can talk about that when the specifics come up.

Frank, did you have something?

PROF. FUKUYAMA:  Yes, I have a slightly different point to make.  I've tried to peddle this idea to a couple of people like Gil yesterday.  So I'm interested to hear what his reaction will be, but I think there's another independent reason for wanting to have more monitoring and oversight over this whole area, which has to do with this whole question we've been talking about in the Council right from the beginning about what it means if you believe, like I do and a number of other council members, that an embryo has some intermediate moral status that's not the equivalent of an infant, but is not, you know, just a mass of cells.  How do you, you know, publicly recognize that or write that into law or grant that status?

And I think that, in fact, this kind of regulation would be a recognition of that moral status, and I'll just give you an example of that, which is the way that we treat dead bodies.

You know, if your Aunt Minnie dies, you can't just dump her body in a dumpster.  You can't render it.  You can't turn it into food.  You can't reprocess it.  You can burn it, you can bury it, you can do a lot of other things with it, but the government takes a very active role in, you know, setting rules and limits on the way that you can treat this object.

And it seems to me that the cadaver in a way is a good analogy, you know, for some other object that has an intermediate moral status that we do not regard as having political rights and so forth, but on the other hand, we don't regard simply as, you know, personal private property that is completely alienable and so forth.

And it seems to me that one of the things that society says if it sets up a system, for example, as existing in Great Britain where every embryo that is created the government keeps track of, is that, you know, in a way it's saying these things are important objects, and even though we can use them for scientific research and destroy them, we don't think that they are simply things that can be disposed of at the whim of, you  know, private individuals and that there's a public interest in keeping track of all of this.

So I think apart from all of the public policy issues about safety and, you know, whether we want to put limits on certain kinds of practices, simply the existence of a monitoring system itself it seem to me, in a way, goes to answering — because this question is constantly being posed within the Council as well.  Okay.  If you say they've got this intermediate moral status but you're willing to destroy them, you know, what does that mean, and I think this is one possible answer to that.

I mean, what it means is that we care really what happens to every one of these individual ones even if some of them are being used for scientific research.

CHAIRMAN KASS:  Let me ask that we bracket a response to Frank's comment only for this reason.  He's really dealing with the question of possible recommendations and policy options.  I would like to see if we have exhausted the comments on the findings themselves so that we can take those things up separately.

Rebecca, please.

PROF. DRESSER:  Just one more question that might be worth talking about.  This issue of access to ART, there is a finding that's indirectly critical of the fact that there aren't any laws or policies that provide access or take a position on that.  That's a hard question for me because we don't have, except for emergency care, we don't have laws that provide any kind of medical care to everyone.

So I think I would want to at least think about access to ART in the broader context, and in terms of setting priorities, going back to yesterday, I think there are some tough issues there, and I don't know if we want to wrestle with them, but I think definitely it is not for me an automatic recommendation or judgment that everyone should have access to these things.

CHAIRMAN KASS:  Mary Ann.

PROF. GLENDON:  This is kind of on the borderline between the two papers, but it seems to me that it does belong under findings.  One of the findings ought to be that these matters, many of them, are regulated in other countries of the sort that we generally compare ourselves with, other countries at comparable levels of social and economic development, that experts in those countries are somewhat surprised that we don't regulate.

CHAIRMAN KASS:  Anything further on the findings themselves?

Paul.

DR. McHUGH:  I have a completely trivial point to make, but perhaps it's useful to make this point.

You frequently use the word that I happen to like about the description of this, namely, reprogenetics, and it may be that we're at a point now where a term of this sort which grasps this discipline enough so as to talk about it rather than going just from element to element would be something that we'd like to recommend to people.  A word like that would be useful.

CHAIRMAN KASS:  No, thanks, Paul.

In fact, as some of you will remember, we floated that term late in the process of preparing the cloning report.  Its appearance in documents prior to its emergence in this room was troubling to some people and it was stricken.

But the Hastings Center's report on these regulatory activities, we heard from Lori Knowles about over a year ago, I think.  That document will appear, I think, in the next issue of the Report, and I think they've got reprogenetics front and center in the title.

And I know that Kathy Hudson's group is using it as well.  So maybe this is becoming not just a neologism that people worry about.  We don't want to be behind the times, but —

DR. McHUGH:  Let me just say that the advantage of it to me anyway is to not only grasp the things altogether, but also talk about how other elements that go on in the realm of reproduction and even in the realm of obstetrics might have ultimately come into play here.

I think I've mentioned to the Council before that I take care of a very sizable number of young women who have been fundamentally distressed by the triple test for Down's Syndrome that gets employed early on in pregnancy at a particular time.  I think you know about that.

What that does is the statistics over time say to the young woman that her chances of having a Down's child change from something like one in 700 to one in 250 and so, therefore, they should go on to an amniocentesis and various other things.

Now, whether they're interested in abortion or not, this test produces in them a most distressing state of mind.  Most of them as you see will have normal babies, and yet the genetic counselors are there saying, "You have the classic presentation for a Down's Syndrome child."  Even when they have an amniocentesis they still worry about it until that baby comes.  They then worry about it in every other baby they have, and they talk to people like me  about what this means.

Now, in France, for example, they insist on all pregnant women having this test, and it's slipped up on women in America, in my opinion, always with the idea, well, you wouldn't want to have a Down's baby as though you begin with that assumption and burden women tremendously in their pregnancy.

And that's an issue of reprogenetics that would ultimately be grasped if we had that concept in mind.

CHAIRMAN KASS:  Okay.  Let me make a couple of comments myself in response to the things that have been said, all of which I think are well taken and could be easily incorporated in the revised version of these findings.

I do think several people, Rebecca, have spoken to, given multiple reasons why this area (a) was the area that we set for ourselves; (b) it is an unusual area of medicine in that new babies are produced, and there are things here that are not strictly just therapeutic that have raised some kinds of concerns in the broader society.

And I think if not at least in the findings, certainly in the introduction of the diagnostic document where I think, by the way, some of that material already exists as to why we're taking this up, that could be strengthened.

I think the distinction between regulating and monitoring and the tremendous importance of getting a lot more factual information before anybody proposes anything restrictive, I think, is crucial.  We are at a very early stage of this process, to be sure, and I think that's the spirit of the enterprise altogether from the start.

And also I think the economic arguments can be beefed up in the presentation both to indicate Janet's concern, but also to suggest that it's not clear that one can somehow deal with this particular question of economics and access separate from the larger ones, at least to flag that question.

And finally, I do think, Janet that I would side with Rebecca to the extent to which some of the things that we would be interested in getting information about we could get information about and seek information even in the absence of federal funding, however desirable that might be.

I mean the longitudinal studies; it's costly.  But if people cared enough about this, I mean, there are ways to get it done.  But I think somewhere between those two points I think we can make that perfectly clear.

The government regulates, even regulates, not just monitors, certain things that it doesn't fund if there is sufficient interest in doing so, and certainly the information gathering in the thing there is that we need, I think, could be encouraged.

Are we prepared to move on?

By the way, if anybody has thoughts that occur to them when they get home on these things or details on the drafting, by all means we would like to see them.

Let's look at the second staff working paper, some policy options.  And here, as the introduction to the paper indicates, we have in a way two purposes, one, to simply lay out the alternatives, both with respect to the possibilities of institutional reform, things that it's quite clear we're not in the position to make any recommendations on in the absence of a lot more study, but at least we can identify some of the alternatives.

And then in some of the substantive areas of concern of the sort the findings have articulated, what are the various kinds of things that could be considered if the public were so interested to address those concerns?

Secondarily, but really more for the next time we talk about this, to see whether there are any specific actions or policies that the Council might wish to recommend as an interim measure while the discussion goes forward.

And here, once again, this is again really more for later.  Given the areas of division, this whole discussion could come a cropper over those matters which divide us.  Nevertheless, the exchange between, for example, Michael Sandel and Richard Doerflinger at the last meeting indicated that there are lots of areas of mutual concern and that the fact that there are some things that might have to be, at least for the time being, off the table.

It shouldn't preclude our trying to find those things on which people of common sense could agree and maybe even unanimously.

So I hope that the spirit that would govern these discussions is at least as much a search for common ground as it is to make sure that the various alternatives are stated with as much force and clarity as the public has a right to expect from a group of this sort.

So let's look at the second working paper and the various policy options.  To remind you, they've really been organized around the sort of larger institutional questions, the four institutional options of: a new agency; the augmentation of an existing one; specific congressional action; and using federal funding as a regulatory lever.

And then the substantive options having to do with the safety and well-being of children, the possible limits on what could be done  by way of implantation of human embryos for research, improved or equal access, the non-disease related uses of genetic screening and embryo selection, germ-line modification, and the various things having to do with commerce.  And then the research involving destructive research on early stage embryos.

Those are the seven areas, and the series of policy options are out there.  And let me just open the floor for discussion without editorial comment.

Jim Wilson.

PROF. WILSON:  I'm not persuaded that we're at the stage in our knowledge where we are prepared to describe any institutional option.  We have several available.  Each has some benefits; each has some cost.  The chief cost in all is that they're concerned with other things, and in my experience adding a new and very different task to an existing federal agency almost insures that that new task will receive relatively low priority unless it's supported by a large body of information conveying the fact that this is a very important matter where a regulatory arrangement of some sort may affect human lives in a desirable direction.

So that though I'm not opposed to designing new institutional options, and we may well come to that, I would prefer focusing as much of our discussion on the substantive issues as we can.

CHAIRMAN KASS:  That said, Jim, could I invite you to comment on not so much about what we're going to recommend, but the adequacy of the articulation of the various issues and the alternatives?

I mean, is this a good beginning in the laying out of those options?  And if they can be improved, have you suggestions?

PROF. WILSON:  No, it's a very good beginning.

CHAIRMAN KASS:  A man of few words.

(Laughter.)

CHAIRMAN KASS:  Good ones.

Comments?  Frank.

PROF. FUKUYAMA:  Yeah, I think the one major option that is really not represented here is a much higher level of self-regulation on the part of the affected industries, the ART industry and the part of the scientific community that is — in fact, Gerry Schatten, I believe, when he testified, said that we need an Asilomar-like process within our industry.  I mean, they do self-regulate already, but presumably this option would involve a new effort given the new technologies that are coming down the line to really impose a tighter set of rules and different enforcement procedures and so forth.

And, again, I mean, to evaluate this I think it would actually be helpful to have an economist, you know, look at this because when you look at the viability of something like self-regulation within a particular industrial sector, it's all a question of understanding the incentives, and it involves a lot of game theory and things that can be analyzed fairly readily if you have the right analytical tools.

But I think it is an important option and certainly the option that the industry will favor above any of the ones that are laid out here.

CHAIRMAN KASS:  Janet.

DR. ROWLEY:  I'd like to make two comments.  One is the follow-on with Frank's, and as I'm sure you're all aware, the medical profession does have a number of societies and colleges that are each one associated with a particular medical discipline, and these are all put together under the rubric of the American Association for Medical Colleges.

And so looking to see which ones people think function most adequately and then giving their both advice but also their experience on this matter of self-regulation might be helpful to us, and so we could certainly consider having someone from that group come and talk.

I do want to speak in favor of Jim Wilson's view that — and I realize you agree yourself— that gathering more data to see what the situation is before we try to figure out how it ought to be regulated would be a very wise approach.

And the last comment I wanted to make is that as we've heard very early on in our discussions, there were a number of panels that have been advisors to NIH on some of these matters.  Each panel recommended that there be an oversight body established, and they were actually fairly explicit about what kind of oversight body should be established.

That's one of the reasons that I asked Lori Andrews a question yesterday, because the RAC is such a body and would a comparable body with some oversight responsibility in this area be appropriate, and clearly her answer was that it was okay to have such a body, but it shouldn't be at NIH.

CHAIRMAN KASS:  Thank you.

Paul McHugh.

DR. McHUGH:  I want to back up both Jim and Janet on this because I also believe that some kind of institutional organization has to be formed to oversee this matter, but it's perfectly true that unless the American public realizes that there are lots of things at stake here, there will not be the energy for this.

There is a little sense that comes both from the RAC experience and from the British experience that unless the scientific community begins to feel that the villagers have their torches out and are going to come and burn down the laboratory that nothing will happen.

I'm very encouraged by what we see in the Washington Post today, that the people are beginning to, like the British people when they discovered that there was genetic changing in their food, then they terrified the scientists to make sure that they did have regulations put in place.

I want us, as a body, and perhaps others as well to remind people that there are awful things that could be happening out there if we don't have oversight, and that the oversight should be opened and developed, and the RAC is a perfect example not only in its genesis, but then actually in its success in managing things, monitoring things, and ultimately controlling things.

CHAIRMAN KASS:  Two things before the scientists come to correct you on this.  First of all, I don't think it's the purpose of this body to get the people out with their torches.

(Laughter.)

CHAIRMAN KASS:  Second of all, and this ties up with Frank's point, the RAC is the legacy of a warning developed by the scientific community itself, and while we have discussed this at some length and my view is that the RAC and Asilomar are interesting but only partially relevant models because they have, in fact, by design confined their attention primarily to the questions of safety where we have additional interests here, nevertheless it seems to me we cannot think about going forward in this area without the active participation and, in fact, the leadership of the scientific community and the biotech industry.  Otherwise what one is going to have is fighting.

One has to, I think, mobilize enough interest on the part of the general public so that people care enough about this to perhaps make it clear that these things might be urgent, if they are urgent, but I don't think that the spirit is the spirit of combat and contention.

DR. McHUGH:  Well, I agree with you, of course, at one level.  I just mean at some point people have to be feeling that this is an inspired enterprise, and it relates to the future of people in America and that it's an important thing.

I agree that, of course, the RAC was something out of the scientific community, but I don't think anyone can deny that the issues of the people of Cambridge, Massachusetts, and their concern for what could have happened with recombinant DNA played a role in exercising the scientific community enough to do what they did.

CHAIRMAN KASS:  Point taken.

Elizabeth.

PROF. BLACKBURN:  A fairly general comment which arises from what you said in your introduction and from the document in our discussion.  What I'm sensing is that — well, my feeling is that this is important enough that we should be thinking about the sorts of principles of governance, in general, and you know, if we think about governance and setting into place how checks and balances are assured, then I think that, you know, the fear that we're sensing is that some group will grab control of this process, but if the governance of it is set up in such a way — and I'm obviously speaking way out of my expertise — but if the governance is set up in a way that people feel, yes, institutionally it does have the checks and balances that do allow the different views to be heard and all the information to be taken into account, then you know, I think we have the makings of a process that will be better and addresses what you're saying, that there may be areas of consensus that can be reached, and if they can't be reached, that at least there's a confidence that there's a process by which the views get heard, and that's built into whatever governance, you know, ends up dealing with these areas.

CHAIRMAN KASS:  That reminds me — Mary Ann, please.

PROF. GLENDON:  Well, I just wanted to say that one of the great merits of the staff work on this paper has been to put before us the diversity of the options that are available under regulation.  I think we have to do whatever we can to dispel the idea that regulation always take the form of banning or not banning, funding or not funding.  I think this is just excellent work in showing that regulation can encompass, as Frank said, monitoring, gathering information, a whole spectrum.

And the techniques, the art of the matter of regulation, the techniques have to be properly matched with the problems, and they will be quite diverse.

Having said that, it seems to me that some of the matters raised here are ripe for consideration with regulations of fairly familiar types.  I would say regulation under the general heading of consumer protection is well known to all of us, and consumer protection sometimes just takes the form of providing information.

So, for example, I mean, a couple of areas that seem to me ripe for moving ahead, areas where we have sufficient information to move ahead, would be these informed consent suggestions on page 8.  After all, with IVF we have a multi-billion dollar industry that is, we have now discovered, virtually unregulated, and ordinary application of consumer protection, laws, and principles would suggest at least the provision of more information to people who are increasingly clients of this industry.

And just another issue that is unrelated to that, but I thought we shouldn't lose track of Frank's interesting analogy to the way our society treats that human cadaver, and I just wanted to add as some support for what Frank said that there are many legal cases in the states which specifically say that no one can have a property right in a cadaver.  The next of kin have certain rights regarding manner and place of burial, but people who have tried to make the claim that they own the cadaver have, as far as I know — I don't know of a single case that has recognized a property right.

CHAIRMAN KASS:  Bill May and then Dan Foster.

DR. MAY:  Sometimes plea for more information can give the impression of a covert argument for delay: "We don't want to really do anything."

But Jim has offered the important plea that we need more information so as to know (a) whether regulation is warranted and (b) what kind of regulations make sense.  This gives a kind of important instrumental value to monitoring.

Monitoring also offers a kind of warning that the society cares, that the society is watching, and thus it begins to serve a kind of cautionary regulatory function even if you don't put in the train actual regulations, it can under certain circumstances.

Yes, reporting and so forth can become pro forma, but on the other hand, it begins to say something, and in a way maybe this paper needs to talk more about the deeper moral justifications for monitoring.  As Jim put it very simply, hey, we're talking about babies.  You really want longitudinal studies.  It's very important.

We're talking about human beings or, Frank's point, we're talking about preimplanted embryos which have an intermediate status, and it deserves being watched.

Monitoring, to steal from old Arthur Miller, means attention must be paid.  Not to monitor in areas like this means literally carelessness.  The society does not care.  As long as it's done in the marketplace, anything goes, and the society at large does not have to firm itself up to pay attention.

So this kind of monitoring grows out of care in some sense that attention must be paid, and I think more needs to be developed along this line in this document.  Otherwise, reading through this document lots of options and so forth, and we need more information.

That doesn't quite answer what the Washington Post was hoping for in this statement.

CHAIRMAN KASS:  Bill, thank you.

Can I make a response?  Because I think absolutely well taken.

Mary Ann, I think, at the last meeting asked that the document have, in the spirit of toward a richer bioethics, that one not simply play engineer and lay out the alternatives, but that one discuss in some kind of thematic way exactly the sort of thing you're dealing with and the sort of thing Elizabeth is asking for, namely, some kind of reflection about the meaning of monitoring and regulation, specially in a country such as ours.

The place for it, I think, is probably not at the statement of the findings or only in the place of policy options, but even could go very early on in the document as a whole.   And it is, I think, our intent to have such a thing, and it's my hope that we can tap several members of the council to help us with the drafting of that.  There are people around the table who have much more experience both in terms of political philosophy, the area of regulation, and even this very beautiful formulation of what it means to monitor and to attend and to care.

I think it would be unusual in a document on regulation and in the spirit of the kind of work that we do to have such a thing in there.

Do you want to pick up on this point?

PROF. SANDEL:  Yeah, on this.  Is that all right?

CHAIRMAN KASS:  Would you?  Thank you.

PROF. SANDEL:  I heard two things in what Bill said, but I may not have heard correctly.  One would be satisfied by language that reflected on the meaning of monitoring.

The other I thought was a suggestion that a call for monitoring would be a reasonable aim that might not be subject to the controversy that you said we should avoid and that might not be subject to the long time it would take to develop and to consider actual institutional arrangements and so on.

Did I hear correctly?

DR. MAY:  Yes, yeah, yeah.

PROF. SANDEL:  And if so, could you, Leon, or might others address the second part of the suggestion that this might be a reasonable proximate aim given our limited time horizon and so on?

CHAIRMAN KASS:  Well, the question of the limited time horizon is open because Frank has raised it.  I think we have a short-term time horizon, and I regard this as a preliminary inquiry, diagnosis.  But we wouldn't be undertaking this enterprise if this group as a whole didn't think that there was some reason to care.

Some people care to the point of anxiety.  Some people care simply in the sense of to pay attention and to think this is important, and my guess is — I'm guessing — that if one formulated the questions properly, there might be unanimity around the table that we would like to have more attention paid officially to Items 1, 2, 3, 4 and 5.

We would like to know about the well-being of children.  We would like to know about the informed consent procedure.  We would like an accurate accounting of the question of the costs, a variety of things of that sort.  The reporting on the uses of PGD that don't have to do with disease if there are any, and the like.

My guess is we might be able to find some kind of an agreement in a call for the paying attention, and my hope is that if there are such things, that they are the expression of an ongoing concern at this particular time that might even be given some effect even as the longer term question of what kind of larger institutional reform might be desirable be a subject of a much more extensive, thorough and careful inquiry.

So exactly.

PROF. SANDEL:  Just a question of clarification.  Would it be going beyond where you think we should go now for reasons of controversial reasons of time to have the staff develop as part of the completion of this regulation, interim regulatory report to suggest ways and to produce a call to monitor the creation and disposition of embryos in IVF clinics in the United States?

CHAIRMAN KASS:  Yeah.  Without getting into the details of the substance, the motion is first the diagnostic document, then the findings, then the laying out of the possible policy options, and then next time we visit this topic, it's my hope that the staff, having consulted with all of you, would be able to put forth a series of possible propositions, of which that would be one, to see whether — looking for the common ground.

Now, is it your suggestion, Michael, that we take that up now and see whether there's agreement on it?

PROF. SANDEL:  Well, I wasn't so much addressing that, though that might be a worthwhile thing to discuss, but really whether you saw within — you've emphasized you want to delimit the regulatory project for reasons of time and of controversy, which I understand and I think all of us understand.  And so I was just asking whether a relatively modest proposal of this kind would be too ambitious given the time and controversy constraints —

CHAIRMAN KASS:  Not at all.

PROF. SANDEL:  — that you have.

CHAIRMAN KASS:  No, not at all.  In fact, in the last paragraph of the italics part of the beginning of this paper there may be matters where nearly everyone is in agreement about the need for more information, for improved oversight, or for specific reforms and action.  Using this document as the point of departure, we would like to discover any such areas of common concern and agreement and whether there might be certain actions the Council would recommend.

And that, I think, would be the agenda item for the next time we visit this topic, probably in September.  So we have one session where the staff has, after consultation, tried to put together a list of such common things to see whether they are, in fact, common.

Dan Foster is patient; has to put up with the loquacious characters.

DR. FOSTER:  One of the things that occurs to me in looking at the overall documents about proposals is this.  One large component of what we're talking about is really not novel, and that is that medicine always is looking at outcomes.  I mean, so we reexamine the use of estrogens and progestins in women long after it has been accepted that it would protect against heart disease and so forth, and we find that there are other questions.  This is a monitoring system, and people have looked to see if what was thought to be truth is true.

And so it doesn't take very much to say what needs to be done in terms of in vitro fertilization and so forth.  There's quite a large experience of it now, and it would be fairly easy to see what we need to find out what the long-term consequences are.  The structure of this does not really require much intellectual thought.

And as a consequence that may be something that's different from the regulatory policies for things of the future, that is, what we're going to do about gene therapy, germ-line therapy.  All those things are new, and as a consequence might require something more distinct and novel than the first part of this.

And it would seem to me that conceptually we ought to make that differentiation, and the first non-novel thing that we ought to follow doesn't require — you might say where you're going to house this and so forth, but it doesn't require anything other than common sense to say that we need to find out what's happening.  Is it true that these children will have more complications, more diseases, and so forth?

It's going to take time to do that. So I would sort of in my own mind want to separate out the immediate things that are not novel, that we have many multi-center trials and other ways to figure out how to do, and that could include what Michael says.  We're going to account for all of the embryos right now.

I think where the big problem is going to come is for the future, those new things that are coming along and where that ought to be housed, and so the only point I'm trying to make is that I think that for me it might be a dual recommendation here, one that really is immediately applicable, and then the other is going to require considerably more thought, whether that's going to be a RAC-like thing or whether it's going to be at the NIH or what it's going to be.

So I think we could move ahead very quickly on some of the things that we need because that's what people are already doing and have done and will continue to do.

I mean, we do lumpectomies or mastectomies.  You know, we just monitor and find that out.

CHAIRMAN KASS:  That's a very useful distinction.  Thank you.

Gil was on the list and then Rebecca.  Gil Meilaender.

PROF. MEILAENDER:  Two things.  One, I mean, sometimes in a group you struggle forever to arrive at something that, in fact, if you just sort of voted on it at the start everybody would have agreed on, and I do think to some degree with part of what we're talking about that's true.

With respect to the idea that more information in the sense of good studies is needed, conceivably even in terms of Mary Ann's consumer protection language.  That doesn't answer Janet's who pays question, you know, exactly where this should happen, but I don't sense a lot of disagreement on that point.

The second point I wanted to make just as a larger issue having to do with regulation understood more expansively than that limited area on which it seems to me we probably actually have a good bit of agreement, Mary Ann had described it as needing to know that somebody is looking out for my interests.

But I think there's a tricky matter here.  There's a good bit of evidence  by now to suggest with respect to the recombinant DNA issue that, in fact, as opposed to arriving at something intended to look out for the people's interests, it was a strategy designed precisely to remove the question from the realm of the people and their elected representatives so that looking out for my interests can sometimes come to mean deciding what my interests are, and that's a different matter entirely.

So I want to make a fairly sharp distinction between some of those fairly basic questions on which I think we have a good bit of agreement, even if some puzzlement, about kind of who would fund such research and so forth, and larger questions about regulation on which I think not only we're not sure, in Dan's terms, kind of exactly what the questions would be or who should look at the, but even what the best way to deal with them that really qualifies as looking out for the interests of all of us.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  I think that maybe this depends on whether our project gets extended, but if we are going to use the RAC as a model in our conclusions/recommendations, I think that perhaps we should get more of a case study of the RAC because it's an interesting entity.

It, strictly speaking, does not have the power to turn down studies.  It has the power to require a public discussion, and even that power is only applied to studies that come from institutions that receive federal funding for rDNA research.

But most of the privately funded studies are also submitted because of this informal acceptance by industry that this is a good thing for them to do.  So it's a mixed voluntary/mandatory system.

The FDA is then the one that backs it up and is trying to work more with the RAC, and they would have the power to turn things down, and they have exercised jurisdiction over genetic modification research.

So it's a little more complicated, I think, and also we should acknowledge that in the Gelsinger case the RAC made a recommendation about that study to make it safer, at least what they thought was safer, and it fell through the cracks.  The recommendation was not followed, and that's believed to be one reason why Jesse Gelsinger died.

So it's not a perfect system, and if we're going to rely on it as a model, I think we should get some more details on it.

The second comment is I don't know if this would be acceptable to people, but a possible supplement to a recommendation for increased monitoring would be and distribution of the information that's discovered perhaps on a Website.  The government, NIH, now has lots of stuff on the Website that's intended to educate patients, prospective research subjects.

So providing a, quote, unbiased account of the information that we have now, as well as the information that's discovered with more monitoring would be another action that I think the federal government could take that would possibly be less controversial.

You might get into debates about what that information should say, but if there were a place where people could go, people who were considering these various methods could go to get, you know, down to earth information on what's out there, what we know about these procedures, that would be helpful, I think.

And then finally, there is another dimension to this outcomes research that might be more controversial.  I think just studying the health of the children, the physical health of the children is probably not controversial, but to the extent that we might want to recommend or discuss outcomes looking at the well-being of these children, the psychological well-being, the attitudes the parents have toward them, those kinds of questions, I think our last standard and outcome studies, I mean, they are looked at that to some extent, but that might be a difficult thing to study and a controversial thing to study.

CHAIRMAN KASS:  Jim Wilson.

PROF. WILSON:  I don't want to disagree with Mary Ann's suggestion that an improved informed consent agreement might be preferable, but I do want to issue a cautionary remark.  I go to the doctor a lot, and even for routine exams, you're presented with a clipboard that has ten sheets of paper on it, and you're told before the doctor can see you, you have to read and sign all of these.

Well, having done this often enough, I don't read any of them.  I sign them.  I'm thinking of having a rubber stamp invented so I can avoid signature bursitis.

And as I look around the room at other patients, a few stare at them, but most simply sign them.  The informed consent procedure is drowning in its own commonness.

Now, there may be a way by designing a kind of document that says, "Warning.  If you follow this procedure the chances of the following unfortunate outcomes rise by X percent," or above a baseline.  "On the other hand, the benefits will rise by Y percent."

Now, my physicians whom I deal with about matters of some importance go to great lengths to explain to me orally in their office what's going on, and I depend on their advice crucially, and I appreciate their professional skill in supplying it.

But the informed consent agreement supplies nothing.  So that before we amiably agree to an improved informed consent procedure, we ought to take a hard look at it to see if it does any good at all.

CHAIRMAN KASS:  Mary Ann.

PROF. GLENDON:  Yeah, I think all of us who consult physicians have had exactly this experience, and I often think as I add my signature I'm a lawyer and I'm not reading the document.  This is what you told your students you must never do.

But I think there is an important distinction between these informed consent forms that we have before medical procedures that we know we've got to have anyway, whatever the risks are, and what happens at an in vitro fertilization clinic where the person who goes there is more like a buyer than like a patient.

It's a buyer of a service, and consumers are very interested, Jim, in knowing — especially consumers of a very high priced service — they are very interested in knowing what is it going to cost, what are the chances of success, what are the risks and the down side, and that's why I put it under the consumer protection rubric rather than under patient's informed consent.

CHAIRMAN KASS:  Frank.  Frank and then Janet.

PROF. FUKUYAMA:  Well, I have two separate points.  Rebecca is absolutely right.  We should not take the RAC currently as a good example or necessarily good example of self-regulation. 

There was actually a 25th anniversary conference or the 25th anniversary of the founding of the RAC where people, you know, evaluated where they were now, and a lot of conclusions were that, in fact, the industry had changed sufficiently such that self-regulation did not work as well now as it did when the organization was founded.

That stands to reason.  This kind of self-regulation works best in small, homogeneous industries that are based in one country where all of the players know each other.  When they get heterogeneous, when there are a lot of, you know, different interests, when you get a lot of international players, this kind of thing tends to break down, and the industry has changed a lot.

I mean, in '75 when Asilomar was first held, all of the funding was federally funded, you know.  There were scientists that all knew each other, and they could police each other pretty well, but the character of that industry has changed.  There are a lot of private players.

I spent some time at Johns Hopkins which has a Center for Civilian Biodefense Studies that's headed by Tara O'Toole, previously by D.A. Henderson, and it was interesting talking to them about the RAC because they're worried about, you know, rogue labs doing bioweapons research, and I asked some of the young microbiologists there, you know, "When you do your studies do you regularly go to the RAC?"

And they all laughed and said, "No, you know, too much paperwork, I mean, and we're not going to do it."

Well, what about, you know, their ability to even know what's going on in, you know, recombinant DNA that may be of concern, you know, for national security purposes?

And they said the RAC, you know, that's not the agency that will do this.

Can I make a completely different point?

CHAIRMAN KASS:  Please.

PROF. FUKUYAMA:  This is a procedural issue about how, assuming that we've got more time to study this beyond the current, just the next meeting.   I think it's really important to get the views of all of the major players. 

I mean, we've got, you know, in the audience today representatives of the ART industry, and I think it's really important to get, you know, a good sense of buy-in and have people talk directly to the Council about their views on these issues.

And I think I just want to reemphasize.  I forget who at this point made this point about how this will not come about unless the industries and the scientific community directly affected by this, you know, believe that this is somehow necessary.

Now, Paul  mentioned, you know, the concern in Europe over GM foods.  It's a kind of odd. I wouldn't raise that as a great precedent because I think that a lot of that, the peasants, you know, with the torches are actually pretty irrational on that issue, and you certainly don't want to encourage that.

But there's an important lesson for the ag-biotech industry that comes out of that European experience, which is that Monsanto in particular had the option of going for a limited form of labeling when they confronted this issue in the early 1990s, and they took the attitude, well, you know, it's going to cost us a lot of money, and we know that the science doesn't support the lack of safety of GM foods, and so they just plowed ahead.

Europeans then clamped all of these regulations, including labeling requirements, and they have been closed out of  European markets as a result.  I think if you talk to their executives privately about whether they regret that decision, a lot of them will say, "Yes.  In fact, even though we think it's irrational, it would have been better for us if we had accepted, you know, a modest degree of regulation that we could live with."

And I think none of this is going to work unless, you know, the affected communities come to feel that this is in their self-interest to do so both procedurally, if you ever design an actual institution, but I think procedurally within the Council it's extremely important to develop this sense of buy-in from people that will have to live with this stuff.

CHAIRMAN KASS:  Thank you.

Janet.

DR. ROWLEY:  Well, I was just following on the comments about informed consent, and of course, this is driven by the government requiring that one has more and more detail for individuals to sign so that hospitals are continually making their informed consent much more comprehensive and, therefore, ten pages long in order to meet the government requirements.  So that is an issue.

CHAIRMAN KASS:  We are close to the end of the time allotted for this session.  Let me see if I summarize the sense of what's here.

There have been specific suggestions both about the findings and about the policy options papers for enlarging them, perhaps shifting the emphasis, but the general sense is that the staff has done a pretty good job in both summarizing and providing the array of things to be thought about, and that the next step really would be to go through this perhaps with some intermediate consultation from all of you and see what kinds of concrete things we might consider by way of recommendations at this particular stage, as well as the things we might encourage for further reflection and study in the next phase of such an inquiry.

Specific comments and criticisms on these documents by E-mail, please, and we will have something for you when we next convene on this topic, which I think will probably be at the September meeting.

PROF. WILSON:  Could we also add this notion of a brief case study of RAC, which I think if somebody could do that it would be extremely helpful to me since I am an outsider?

CHAIRMAN KASS:  A brief case study.  I think it's a major job.  Am I wrong, Rebecca or Frank?

I mean to do this properly would be —

PROF. FUKUYAMA:  There's a literature, though.  There's an existing literature on this.  So I think you could fairly easily review what has been written already.

PROF. DRESSER:  That would be a shortcut.  Just give some articles at this point and then maybe later decide.

DR. ROWLEY:  Of course, another thing one could consider, Ted Friedmann is the Chairman of the RAC.  He has already come and spoken to us on gene therapy, but it might be possible either to have him come or to ask him.

Now, some of you may say, "Well, he's got a vested interest.  So it's not going to be the same," but you know, he is a pretty thoughtful individual.  If he could write a paper, such as Catherine Verfaillie or Jim Thomson did, for our next session, that might be a helpful perspective in addition to the literature that you're citing.

CHAIRMAN KASS:  Why don't we take under advisement some way to get some kind of material, whether from Ted or from the existing literature at least as background if not at the meeting so that when we next time meet we have a further sense of how that has been working.

For a change, we finished a session on time.  Am I right?  Yeah.  In 15 minutes we'll reconvene at 10:15 for the next session.

(Whereupon, the foregoing matter went off the record at 10:01 a.m. and went back on the record at 10:22 a.m.)


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