The President's Council on Bioethics click here to skip navigation

 

Meeting Transcript
October 17, 2003

Ronald Reagan Building and International Trade Center
1300 Pennsylvania Avenue, NW
Washington, DC 20004

 

COUNCIL MEMBERS PRESENT

Leon R. Kass, M.D., Ph.D., Chairman
American Enterprise Institute

Elizabeth Blackburn, Ph.D.
University of California, San Francisco

Rebecca S. Dresser, J.D.
Washington University School of Law

Michael S. Gazzaniga, Ph.D.
Dartmouth College

Robert P. George, D.Phil., J.D.
Princeton University

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Charles Krauthammer, M.D.
Syndicated Columnist

William F. May, Ph.D.
Southern Methodist University

Paul McHugh, M.D.
Johns Hopkins University School of Medicine

Gilbert C. Meilaender, Ph.D.
Valparaiso University

Michael J. Sandel, D.Phil.
Harvard University

James Q. Wilson, Ph.D.
University of California, Los Angeles



INDEX

SESSION 5: BIOTECHNOLOGY AND PUBLIC POLICY: PROPOSED INTERIM RECOMMENDATIONS

CHAIRMAN KASS:  Could we get started?  I'd like to welcome Elizabeth and thank her for the extraordinary extra effort to get here for what is just a half a day of meeting.

We wore each other out, or at least I wore you out, yesterday.  We didn't quite finish the discussion of the recommendations in the biotechnology and public policy project.  And my proposal is that since I don't think the two papers from the stem cell project that we need to discuss today will take us—take up the full three hours that we have together that we try in a somewhat expeditious way to finish up, beginning from where we were yesterday.

I think there was reasonable agreement on principle, on one item under point one, one item under—the one item we have under point two suitably revised, general agreement on principle with some rough edges and the need to revise language.

Michael Sandel has indicated that he would like to introduce at least into the record for consideration of our redrafting process a formulation that he thinks might satisfy everybody.  And as a person who is interested in something that would satisfy everybody, I can't refuse him the opportunity to let us think about it. 

But I would like to suggest that we not discuss it now, and it will be in the transcript.  We will send it around, so that we'll find out indeed whether this satisfies everybody.  But let's begin there, and then we will go back to the point four, and in fact take up the patenting question, which is I think the only thing we had left.  And then we can move on to the other papers.

Is that procedure agreeable to everybody?  Anybody have an epiphany overnight that would solve all our other problems?  Yes.  It was a bad night.

Michael, go ahead.

(Laughter.)

PROF. SANDEL:  Well, I understand we don't have time to discuss this, though I would be interested if the chair thinks this would be useful, after I present this proposed compromise just to see by a strawpole where there is anyone who would object to it.  I put that to the chair as a suggestion.

We were in Section 3—this is where we had this long, drawn-out discussion, and there are two prohibitions proposed on page 12 in the bold print.

And most of the discussion focused on whether—and here I'll speak for myself—the position that I was advocating was that it's one thing for Congress—for us to call upon Congress to prohibit attempts to conceive a child by any means other than union of egg and sperm, whereas I thought that it's more suitable for a regulatory body to deal with what I viewed as somewhat arcane and speculative procedures having to do with producing children by fusing blastomeres or fertilizing—using gametes obtained from embryonic stem cells or fetuses.

And so I was arguing that that—what seems to me arcane and speculative, but probably undesirable, should be dealt with by a regulatory body, not by Congress.

But on reflection, I would be prepared to compromise on that issue.  If people feel strongly that those procedures really do loom as a sufficient threat that we should have Congress, not a regulatory body, deal with them, then there is a fairly simple way.  And I, for my part, would be happy to support this—for Congress to prohibit both sets of practices, and that could be embodied by adjusting the language in this on page 12 in a modest way.

Leon observed that the second half of that first prohibition and the second prohibition are redundant.  So I would propose simply resolving—doing away with the redundancy in the following way.

We would retain the first prohibition up to the point where it speaks of the union of egg and sperm.  So we would say, "Call upon Congress to prohibit attempts to conceive a child by any means other than the union of egg and sperm," period, deleting what follows.  That's what caused all of the—much of the controversy.

Then, two, retain exactly as it's written the second provision, "Calling on Congress to prohibit attempts to conceive a child by fusing blastomeres from two or more other embryos, or by fertilization using gametes obtained from a human fetus, or derived from human embryonic stem cells"—to retain that.

So that we would be asking Congress to prohibit any attempt to conceive a child by means other than union of egg and sperm.  Simple, straightforward.  And for those who feel very strongly about these new procedures, we would also ask Congress to prohibit using the blastomeres or the fetus or embryonic-derived stem cells.

CHAIRMAN KASS:  I think we have the language.  I think we will—

PROF. SANDEL:  Is there any reason why that wouldn't satisfy everyone?  Would you be willing to take a—see if there is anyone who objects, because if no one objects we can simply move on.  It addresses all of the worries that were raised yesterday.

CHAIRMAN KASS:  Anybody want to make a comment?  I will not regard this as a straw vote.  I mean, I think—well, the language is here before us.  But does anybody want to say something, one way or the other?  Gil?

PROF. MEILAENDER:  Well, I would simply need to think about it more.  It's not quite clear to me that it does, in fact, capture everything that was there in the original two.  It doesn't have the more than two adult human parents.  So I just need to think about whether that's dispensable or not.

CHAIRMAN KASS:  Bill Hurlbut.

DR. HURLBUT:  There is one technology that may be covered in the first half of the first provision, but we haven't mentioned it.  It's a realistic technology, it appears to be possible, and that is splitting an embryo to create identical twins.  And it's a—sort of a far-out scenario, but it's been floated for quite a while—the idea that you might—some people might want to split their two-cell embryo and save one cell as an alternate embryo for identical twin spare parts or stem cells cultivation later.

They do this routinely with animal embryos.  They split them to produce multiple identical twins.  So someone or another, maybe that's covered under the provision of two—

CHAIRMAN KASS:  No, that's not here at all.

DR. HURLBUT:  Well, anyway, it should—I think it should be covered.  It's a realistic technology.  It's not something that would even need developing much more.  It looks like it's possible.  It was done about 10 years ago with an aneuploid embryo they grew for three days and then—

CHAIRMAN KASS:  Elizabeth.

PROF. BLACKBURN:  My sense about Bill's comment is that I think it's dealing with a separate issue from the issue that these—I don't think it's—it's not the same issue as this one here, but this seemed very clear, these recommendations.  And it seems as if they would be clear and not produce unwanted sort of unanticipated ramifications.  So I think it's a good suggestion.

CHAIRMAN KASS:  Paul.

DR. MCHUGH:  I also—this is the first time I've heard it, and I would like to think about it.  But I wanted to make a point that comes up when this is mentioned.

I am supportive of everything as written in this document.  At the same time, I think it's important for us to remember what we are doing.  We are not writing legislation.  We are trying to be clear to the American people of exactly what we're against, what we want to be sure of, that they are thinking about—they'll craft this, and they'll think about this, ultimately.

I'm fearful that in the process of writing our prohibitions that we're not—that we distract people into all of the arcana of science.  Again, I'm not sure that Congress is going to have the skills to work it out themselves.  But at this point, if we lose sight of what our message is, or we blur our messages with codicils and things of that sort, I think we'll lose our strength.

And so I want to think about what Michael has said to see if it simplifies and makes clearer to the people what I'm—

CHAIRMAN KASS:  Absolutely.  And as Michael and I conversed previously, the question is what Congress would make of talking about blastomeres in the first place is one of the problems.  That's part of the reason why the language of the first—we'll work on it.

One wants to present things—I'm in full agreement with Paul.  One wants to present things in a sound—carrying a certain kind of sound, ethical good sense, and not encumbered by things that either will unnecessarily complicate the matter, purport to be legislative drafting, or go beyond what we think has a reasonable chance of being successful.

Rebecca, and then Mike, and then I'm going to move us forward.

PROF. DRESSER:  I agree that we shouldn't be trying to draft legislation, but I also think we should take into account that, especially when we're saying something like "Congress should," and then we put in bold these words, I think they will be interpreted—or they certainly will be a baseline, and our language may be quite influential.  And so I think we should keep that in mind.

One virtue of this proposal that Michael made is that it would make our statement clearer in that if we omitted if this "no more and no less than two adult humans," we wouldn't have to have this footnote on "ooplasm transfer."  We wouldn't have to then respond, well, that we're not covering surrogacy, even though the general principle might well cover it.  You know, we just wouldn't have to deal with any of that.

CHAIRMAN KASS:  Those are considerable virtues.  I think we all want to think about it, but many thanks to Michael for perhaps splitting the baby and allowing us to move forward.

Mike Gazzaniga.

DR.GAZZANIGA:  Just quickly.  In the spirit of simplicity, I would go back to the earlier suggestion yesterday of just stopping at the end of egg and sperm.  Period. 

Because all of it becomes detailed, and I can't—actually, I would find it—I would tune in to C-SPAN to see Congressmen talking about blastomeres, just to see how that went.  But if we don't want that public spectacle, I would say we abbreviate—

CHAIRMAN KASS:  What about—do you feel the same way about the second half of the second provision?  I mean, I think they can pretty well understand gametes obtained from a fetus or derived from stem cells.

DR.GAZZANIGA:  We'll wait for the revision.

CHAIRMAN KASS:  Okay.  People will sharpen their pencils and their erasers.

PROF. SANDEL:  Addressing Paul's point about simplicity, the reason I would add the second is that there are people who are worried about those practices.  And though I think a regulatory body should deal with them, fine, I'm willing for Congress—the reason I think—the virtue of simplicity I think is important.

And whatever other practices we think should also be prohibited under this section in the drafting, I would urge that for the sake of clarity, principle, and simplicity, that the first provision, the first proposed prohibition, be stated exactly as it is with the period after "egg and sperm."

And that if there are any other practices that we worry about—Gil thinks maybe we aren't providing sufficient barrier to having more than two parents—that that be added, if need be, even as a third item simply, clearly, in its own, so that the first one can stand simply and clearly about the union of egg and sperm, which the American public can understand clearly and readily.  And if there are other more arcane or detailed worries, they can be listed in a second or a third item in their own right.

CHAIRMAN KASS:  All right.  I think we have our work cut out for us.  Let's go back to where we were and offering a summary of exactly how we put the prohibition on—page 13.  If I understand the discussion last time, both of—the two points at the top of page 13 survive with the deletion of "eggs and sperm" under the second point; namely, prohibition on the buying and selling of human embryos. 

And more importantly, or equally importantly, with suitable change of the language to be worked out—that we don't ourselves pick the date.  There's a division in the House as to whether it should be 10 days, 14 days, but suggest to Congress that it find some time at that particular point, and that it be made clear that this—we are speaking about those embryos that are already being used for research and indicate more clearly in the language surrounding it that there are at least some people of the Council who think there shouldn't be any.

I think that was more or less the sense of the discussion yesterday, and that would leave us with the matter of patenting; namely, that there should be instruction to the Patent Office not to issue patents on claims directed to or encompassing human gametes or human embryos or fetuses at any stage of development, and to amend the U.S. Code on patent protections to exclude these items from patentability.

Now, we did have a lot of discussion here long ago on patenting.  There was a suggestion at that time—and, by the way, I don't think that there was—insofar as we discussed this, I don't think there was a lot of disagreement. 

The disagreement was whether or not, especially given the climate at that time, that it made sense for the Council to make a recommendation on patenting of embryos alone, in the absence of a fuller exploration of questions of the human body and commerce, and where—a point Michael made yesterday—his reluctance at least that this not be seen as one more installment of embryo and abortion politics.  I don't think I misquote you on that point.

But now this comes up in the context of the overall consideration of biotechnologies touching the beginning of human life, and this now fits in the broader context of our work.  And in keeping with the respect that is owed to nascent life, at least special respect—as this document has tried to suggest—it seems to me appropriate for us to bring this thing back.

And here I would point out that following Michael's suggestion—and I endorse it myself completely—that when we are talking about—it would be very hard, it seems to me, to succeed with the prohibition on the buying and selling of eggs and sperm.  These are—the latter is a more or less longstanding practice.  The first is a rather successful practice; however, you try to gussy it up by suggesting it's just for time and inconvenience.

But the area of patenting is different, and this is, it seems to me, new ground.  And if this is, again, a moratorium in which one suggests that this be a block until people provide reason for overcoming this taboo, I think this is perfectly fair game.

And I would like myself to propose—to support the suggestion that even if human gametes don't have the—are not entitled to the same respect or for the same reasons as human embryos, bundling them together here is perfectly appropriate.

So I would like to put that—those—that two-part singular proposal before the group and see where people are.

Robby, look puzzled.

PROF. GEORGE:  Just how would it read?  Would it read—

CHAIRMAN KASS:  Well, that's a good question, actually.  I mean, the easiest thing would be to say, "We recommend that Congress amend Title 35 of the U.S. Code to exclude these items from patentability."  If that were done, I think the other would be moot.

But until Congress acts, one might say that it should be accompanied by a recommendation to the Patent Office, because the legislation might take time.  That patents ought not to be granted on claims directed to or encompassing gametes or human embryos or fetuses at any stage of development.  That would not—the first of these is not a recommendation to Congress but to the Patent Office. 

Am I correct on that?  Let me just check with my—I'm sorry?

MR. LEVIN:  Title 35, the line here is just about—the language there states that processes that are patented result in products that are automatically patented.  So that alone wouldn't actually exclude products from patentability.  That's why there's two sets of terms here.

In other words, if you just have the Title 35 amendment, what you—you then just exclude from patentability the products of patented processes, but you don't directly speak to the products separately.  That's the reason for these two -

CHAIRMAN KASS:  And it's quite clear that we are not intending to exclude from patentability the processes, but simply the products themselves.

Robby, proceed.  Just make clear the various possible reasons why you might be troubled.

PROF. GEORGE:  Well, my concern is only with the bundling issue that you mentioned a moment ago.  And I, if possible, would like to avoid any suggestion of equivalence between gametes and embryos, although I also respect the need for language that respects Michael's position here as well.

I mean, we're all wanting to accomplish the same thing, and I think we just need language that will not connote anything that one side or the other doesn't want to—

CHAIRMAN KASS:  I don't see why the language, as written here, says that these things are equivalent.

PROF. GEORGE:  It's connotation I'm concerned about, not denotation.

CHAIRMAN KASS:  But, well, and maybe in suitable justificatory language one could provide this.  But if you read the earlier part of this document, gametes are different from skin and liver cells, because of their capacity to be the seeds—because they are the seeds of the next generation.  And that means that even if they are not of comparable worth as an embryo, they are things for which we would - and the transplant laws have already acknowledged that.

PROF. GEORGE:  Agreed.  Yes, I have no problem about that, and I like that language, and I think it's a very adequate description.  I'm just concerned about phrases or sentences taken out of context, quoted out of context from the complete report.  And I don't think there's a problem with coming up with language, and this is not a big objection I'm making.  I just want to be careful that the language—

CHAIRMAN KASS:  Let me offer a Sandelian suggestion—not to issue patents on claims directed to or encompassing human embryos or fetuses at any stage of development, period; not to issue patents or claims directed to or encompassing human gametes, period.

PROF. GEORGE:  Done.

DR.GAZZANIGA:  But I certainly want to know what's at stake here.  What's lost by that?  And one could imagine the development of gametes that might have rid disease from the progeny, and that they should be somehow protected because of all the investment and costs that went into developing them.

In other words, just to all of a sudden land on this issue and say we want to stop this, I am not at all clear and would want to learn more about what the cost—what might be lost by such a law.  I'm not clear on that.

CHAIRMAN KASS:  Discussion?  Do you mean with respect to the embryos or the gametes?  Just the gametes.

Rebecca.

PROF. DRESSER:  I think that's a good point.  I'm not sure, but I might think that it would be appropriate to limit the prohibition to embryos and fetuses and not gametes.  I'm just not sure, because I don't have enough information.

CHAIRMAN KASS:  Bill.

DR. HURLBUT:  In something like 15 percent of cases in assisted reproductive technologies, they have no explanation for why there is infertility.  And one of the dilemmas seems to be the penetration of the egg by the sperm.

There might be potentially even commercially viable alterations of gametes that would be used for clinical studies.  There is probably a lot of good science to be done by altering gametes and then studying how they relate to the surface markers and stuff.  I mean, I understand the spirit of the intention here, but I—in my imagination, I can picture patentable—processes I guess what we're talking about here.

CHAIRMAN KASS:  No, no, no, no, no.  The processes are protected.

DR. HURLBUT:  No, I'm sorry.

CHAIRMAN KASS:  Yes.

DR. HURLBUT:  I can imagine patentable products that might have some scientific or therapeutic use.

CHAIRMAN KASS:  Let's think it through.  What would be—someone patents a process to genetically modify sperm to increase their capacity, right?  And anybody else who wants to use that—they patent the process.  Anybody else who wants to use that in their fertility clinic now has to pay up for the right to use the process.

What in the world do they need the limited ownership of those sperm—I mean, just to declare kind of a limited property right in human eggs and sperm.  Now, it's different, it seems to me, if you're dealing with individual cases of singular donors.  And let's even grant the conceit that they are inconvenienced, and the women, if they do donate eggs, it's more than inconvenienced, right?

But there you've got individual donors for individual patients, and a claim that it—I mean, we have reservations about this, all of us do, to begin with.  But this is now large-scale commerce.  And the question is:  don't you protect the rights of industry and their activities sufficiently in this area by protecting the processes that produce these things without giving them sort of ownership over gametes in that kind of way?  That's why I'm I think with Michael on this one.

PROF. BLACKBURN:  I did think of something which relates to what Bill was—the scenario he was raising.  So let's imagine that some batch of such modified sperm by some process have been generated by somebody who wants to patent these, and that those are then made available on a commercial basis to ART clinics who use them as their standard to validate their own procedures. 

And so they're used sort of to validate what they're doing to make sure—you know, in experiments you always want to have a reference sample.  And so those could conceivably be a reference sample, which would not be themselves used for reproductive purposes, but which would be the sample of the known things that do work that it could be compared to.

So I could see that there might be that kind of thing where it is the objects themselves rather than the process that—where the subject—

CHAIRMAN KASS:  So like human eggs and sperm as reagents for testing.

PROF. BLACKBURN:  That's what I'm saying, because, you know, ART clinics may have to validate various of their procedures, and from a known reference point.  So I could conceive of such a scenario in that way perhaps.  I mean, I haven't thought through the ramifications.  I'm just saying that I—just to answer your question, that you could conceive of a—the object itself rather than the process could perhaps be seen as something that's—

CHAIRMAN KASS:  Okay.  So with the help of Elizabeth's suggestion of offering us at least one instance where rights—patent property rights, if one can say that, in the product itself would be valuable to the producers. 

Then we are back into our usual circumstance of saying, is this one of those things where the mere fact of some kind of use is sufficient to override certain kind of moral scruples?  Is it a draw?  Is the moral sensibility that's at issue here of sufficient weight to say—as Bill May said, this is a kind of taboo area.  We need absolutely powerful reasons before we violate it.

I think it's worth a little further discussion to see where we are.  Rebecca, please.

PROF. DRESSER:  One parallel to think about would be the oncomouse, the Harvard mouse.  The people who developed that mouse, they wanted the patent on the process and the product of the mouse.  And it's controversial in Europe, and they haven't—they've really been fighting about whether to extend patent protection to the mouse and not just the process.

So I guess we can think about, well, gametes—should they be like—I mean, obviously, the people who invent these things would like to have the patent on both.  I suppose they must make more money that way.  So we would have to think of a reason why gametes should be different.

CHAIRMAN KASS:  But look, I mean, here's the history of all of this.  And this is where I think taking this particular piece up under—only under the auspices of human procreation is somewhat distorting.  I mean, this is where we are, and this is where it is.

But you start with the Chakrabarty decision in which it is not sufficient for the vendors there to gain rights over the process.  And the court I think wrongly interprets the existing statute to say an organism is a composition—a mere composition of matter for the purposes of this.

And then, the march is on, and the march of patentability has now reached not just genes, and not just animals, but is now coming closer and closer to us.  And here are places where you could say, you know, no further until you show us why this line should be crossed.

Now, you can say—some people would say, well, I'll surrender gametes, and I'll hold the line at embryos.  But I'm not sure.  I'm not sure that you want to even be comfortable with the patenting of modified human body parts.

PROF. DRESSER:  May I ask, why isn't there discomfort about granting the patent on the process, then?  What's the difference?  They're still making money from—

CHAIRMAN KASS:  No.  It's—well, I don't have an aversion to their making money, and I think Mike's point is well taken.  I mean, maybe they're making too much money, all kinds of other things.

But unless this is going to be an act against commerce altogether, the question is:  what is somehow represented in claiming the ownership of the parts and of the things themselves?  That's a very different matter.

Michael.

PROF. SANDEL:  Well, the issue is whether we want to sanction or discourage the idea of having property rights in embryos, gametes, life forms, oncomouses, or I would say also human genes, which we haven't talked about.

I think that it is, as Leon says, artificial in a way to raise the patenting issue under this heading.  I would rather that we—perhaps if we can't agree on dealing with the gametes and the embryos together here, because it came up in that connection under the heading of a worry about respect for early stages of nascent human life and for the seeds of human life. 

If we can't agree to include them both here, it might be better as a separate topic—to strike this all together, and as a separate topic to take up the question of the patenting of life forms, and to raise the general question whether we should recommend—as a topic in bioethics, it's a perfectly good one—legislation that would overturn Chakrabarty. 

And we could deal with, one by one, whether we think there should be property rights in human genes, whether there should be property rights in gametes and embryos, whether there should be property rights in oncomouses for that matter, and deal with the topic as a whole.

CHAIRMAN KASS:  I don't think these are incompatible.  I mean, if there is—if we can get an agreement here on this, I think we should take it and continue those discussions. 

Let me ask both Elizabeth and Mike Gazzaniga—Elizabeth hasn't sort of declared herself on the question of the patenting of the product, but simply did us the service of indicating why someone might have—why a certain product might, in fact, be marketable and useful.  And Mike wanted to make sure that we knew what we were doing when we were going down this road, lest we deprive entrepreneurs and inventors of the profit owed to the fruits of their labors.

But do either of you, given this discussion, want to say something on the merits?

PROF. BLACKBURN:  I think just the very fact that I could think of one instance it makes me feel I haven't thought it through enough to—you know, this instance didn't occur to me until Bill made the comment about this, so—

CHAIRMAN KASS:  But, I mean, let's assume that what you suggest is actually true.  Would you then be inclined to say sufficient unto the day is a patent on the process, but they can't own the gametes?  Or would you want to say—

PROF. BLACKBURN:  Well, I don't know that there would be unintended consequences of the nature that I was talking about.  You know, let's imagine the scenario was a really very good one, and really was very—you know, turned out to be very helpful for the process of, you know, ART in certain settings, let's say.

So that's the thing, I don't want to just say no, because there may be ramifications I haven't thought of.  And I feel embryos and gametes to meet—you know, I do feel differently about them, and so I wouldn't feel in the same way about sperm as, say, embryos.

CHAIRMAN KASS:  Mike, do you want to offer something on the merits?

DR.GAZZANIGA:  There are issues at all levels on this particular point that also can take you up to issues in medical economics, whether this is just crazy to—to allow this.  Not for any ethical reason of the type we're talking about here, but that it's putting a burden on the medical system and the cost of medical care that is not acceptable.  So there's a whole body of information on that that I'm a little bit familiar with.  But I just feel when you come to a point as serious as this, I need checking time.  I have to go snoop around. 

And it gives me a thought, Leon, that—almost a schoolboy suggestion here.  We're all busy.  We all get these books.  We're all trying to read them, and we're all harried.  And probably our first, in many instances, really coherent thought about this is right in this room as we try to work it through, focus our attention, and so forth and so on.

So I'm wondering if in instances like this you—as the books go out with enough lead time, you also give assignments.  Okay, Gazzaniga, you check number 5, and you do the spade work.  And if we've missed something, you come and tell us about it, and so forth.  Because if we try to do it en masse, we just—we can't do it.  We don't have the time.

And I don't know, it's just a thought that this point is so evident to me that I'd want to—

CHAIRMAN KASS:  Okay.  Other comments?  Alfonso.

DR. GÓMEZ-LOBO:  I want to make a more general comment here.  This, to me, it sounds like one of those instances where technology is taking us one little step further, one little step further. 

What I really worry about is the issue of instrumentalization of children involved here.  I mean, I was thinking, what is it if you have to tell you child, oh, you know, you were conceived with very expensive gametes, because we had to pay these patent-holding people to get them, etcetera, and the—because this would happen if they were patented.

Now, that seems to me so counter to what, you know, the giving of life should be, the acceptance of life.  I mean, we're going into a full-blown technification, manufacture of children if we go this route.  And I know it's very difficult to set a dividing line.  We've seen it, I mean, in many issues.

Now, in the case of patents, I think that would be a minimum that should be thought about, not the process but the product.  I mean, I would personally feel very strongly that not only embryos but also gametes should not be patented in that manner.

But my reason is this overall view of where we're getting in terms of human reproduction.  And I'm thinking about—all about the child.

CHAIRMAN KASS:  This is the spirit, in fact, of this entire document—to set these kinds of boundaries against that march.

I have Paul and then Gil.

DR. MCHUGH:  I'm not sure I have much to add, except a personal note.  I've been arguing for 40 years with my fellow—I remember beginning that argument with my fellow medical students about their buying and selling of eggs and sperm.  So I come back to this original idea that I'm—I've been against that for a long time.  But I realize that it might be, you know, a quixotic point to try to force it.

But what—I would like to see something written here that would say we are—would like to prohibit buying and selling of human embryos, eggs, and sperm.  And, by the way, we would like to from that point consider that the patentability of these gametes, as well as these embryos, is an issue that the American people should pause over before they let it happen.

I mean, it's that kind of—I mean, once again, I want to make this a clear statement to the American people, not carving out legislation.  I want people to know what we're agin.  I've been—and so since I've been agin all of this stuff for a long time with my fellow medical students in the 1950s when they began selling these damn things—speaking from the heart today.

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  I want to—well, I have a lot of confusions.  I remember my confusions when we had our sessions on patenting.  Talk about an arcane area.  Extraordinarily complicated.  And I wouldn't claim clarity on, you know, some of the claims about possible scientific uses of these things.

So that brings me back to what I thought this document was supposed to be about.  It wasn't necessarily what in my ideal world this document would have been about, just what it was about.  And that was a search for certain things, possibly only a few things, on which we all agreed that we were prepared to draw a line.

That's what—if that's not what we're after, if what we're after is kind of telling the American public what we're really against, hey, I've got a whole list of things that are going to have to go in here, you know?

(Laughter.)

We're not anywhere near that here.  So if what we're looking for is just kind of a bare bones version of a few things, really almost less for the purpose of getting those prohibited than for the purpose of saying, you know, it is okay to prohibit some things, lines can be drawn. 

Then, well, there's a clear line for me between gametes and embryos, and I'm a whole lot clearer—I don't have a problem with—if we're talking about embryos.  And as soon as we start talking about gametes, then all of those complications that I don't understand with respect to both patent law and the science of it become significant for me.

So it depends on what sort of a document this is supposed to be.  But if it's supposed to be just sort of bare bones, almost symbolically to say there are—you know, it is possible to say that something that might conceivably be useful, nevertheless may not be done, then I don't feel the need to go whole hog here.

CHAIRMAN KASS:  Michael.

PROF. SANDEL:  I'd just like to say that I agree very much with Alfonso's statement about gametes and embryos, which I think really gets to the heart of the matter, the moral heart of the matter.

CHAIRMAN KASS:  Robby.

PROF. GEORGE:  Leon, what Gil said strikes me as correct.  If we are not united, or if we need additional information in order to get where we—where I would like us to go on the gametes issue, then perhaps that needs to be laid aside for now.

CHAIRMAN KASS:  Well, let me see if I understand what I've heard.  What I've heard mostly is that there are no dissenters on the patentability of embryos.  There is a lot of support for an addition on the patentability of gametes, with a couple of reservations and concerns.

Gil is puzzled by what that might mean.  Elizabeth points out the possible utility of this and wants to think some more about whether that utility should override any kind of presumption of placing gametes into—the gametes as opposed to the processes into commerce.  And Mike thinks that we should get some more information before we know what we're doing on this matter.

PROF. MEILAENDER:  Bill raised some questions, too, didn't he?

CHAIRMAN KASS:  Well, but he didn't raise a question on—you simply spoke about the usefulness of this, right?  You haven't yet made an argument that would lead one to say that there should be patentability of the product as opposed to the process. 

In fact, you—let me not guess what you think on this. Why don't you put something on the record, so that when we go home and ponder this—I mean, are you saying that with respect to patentability—and this is not a question about whether you think gametes and embryos are equivalent, but the question of whether or not the possible usefulness of engineered gametes, either as reagents or as benefits to reproduction, are sufficient that you would not want to exclude these from patentability.

DR. HURLBUT:  My concern was given the fact there are so many cases of infertility in which they don't know the cause, there's no evident cause, and one of the things that they sometimes need to do is then take the eggs and fertilize them and see what's actually happening.  And it might be possible to develop gametes that had no potential to form an embryo but could be used in a lab procedure to see what the barriers to fertilization might be.

CHAIRMAN KASS:  I see what you're saying.  Is that the sense of the group for the time being, or should we go home and work on it?

PROF. SANDEL:  Right.  To keep embryos and not gametes?  No.  Then, it becomes the—instead of the President's Council on Bioethics, it becomes the Brownback Council on Bioethics.

CHAIRMAN KASS:  I don't see that, Michael.  I really don't—I think—

PROF. SANDEL:  For exactly the reasons you stated at the outset.

CHAIRMAN KASS:  No, I don't think so.  I mean, that's been your concern.  But you yourself and other people here have indicated that the human embryo is entitled to some special respect.  No one has pressed you terribly hard when you also say "so are sequoias, and so are other things," as if you meant by that that they were somehow equivalent in their claim on special respect.

In the context here, however, it's a perfectly natural outcome of this discussion to say, "We don't all agree."  In fact, the text is going to say quite explicitly we don't all agree as to whether the embryo is fully one of us or not.  But we do think that it does not belong as an item in commerce, and we don't believe that it belongs as an item in patentability. 

This is somehow the correlative of the point earlier prohibiting the buying and selling of human embryos.  And I would suspect that there are lots of, you know, ardent pro choicers and feminists who would not be unhappy to support this kind of provision without declaring themselves members of the Brownback party. 

I just don't see that—I mean, it might make somebody uncomfortable having to go back and explain to their friends why they voted for a ban on the buying and selling of embryos, and not the buying and selling of livers, kidneys, and ovaries and gametes, but I don't see the necessity of it.

PROF. SANDEL:  But then, but if that were the case, then read the first sentence in Section 4, which is the preamble to these—page 12, which lays out the rationale for the prohibitions that follow.  It says perhaps people are now proposing to change this, too. 

Respect for early stages of nascent human life, and for the seeds of human life, setting some agreed-upon boundaries on how embryos and gametes, eggs and sperm, may be used and treated, and then it goes on to say the degree, you know, will continue to arouse great controversy, and so on.

But then, the prohibitions that flow from that preamble on this proposal, none of them would mention what the preamble says is the purpose.  None of them would mention the seeds of human life or gametes or eggs and sperm.  So is the proposal to amend also the first two sentences, and the first sentence in the preamble of Section 4?

CHAIRMAN KASS:  Jim, do you want to comment?

PROF. WILSON:  Yes.  I don't think we become the Brownback Commission or the commission of any particular party when we recognize that for a variety of reasons, some scientific, some ethical, some simple ignorance, we're unsure about gametes.  I would be prepared to vote to ban their patentability, but other people have raised questions that hadn't occurred to me.

If we strike it and come back to it, it seems to me we've lost nothing, because I take it we're unanimous on banning the property rights of embryos.  And if the Patent Office is sneaking up to try to do what we believe it must not do, this is the time now to act on this matter. 

Congress seems to be absolutely polarized on this question, because it thinks only in terms of the rival claims of the Brownback and the Kennedy bills—claims which I doubt will be resolved in the near future.  But this patentability issue, that can be resolved right now.

PROF. SANDEL:  Well, to reply to that, I think there are two reasons, though.  I am against patenting human embryos, and I am also against buying and selling them.  I think there are two reasons why, if we can't agree on the gametes, we should drop this and take up the general topic of patenting and include the range of things.

But two reasons I think it would be a mistake for this committee.  I think it would simply confirm, in the minds of many in the public and the press, an impression that we have all been combatting, that this is a committee with an agenda to—an embryos politics agenda.

I think that that's a false charge, but I think that if we enacted this only about embryos, and didn't discuss the patentability of other things, that it would make the committee vulnerable to those accusations, number one.  And, number two, people would say, "Well, have people proposed patents on human embryos?  Is this a pressing problem?"  And no one here has said that anyone has made such a proposal. 

So given those two facts together, I think though I am against patenting human embryos, I think that it would bring discredit on this Council, and would confirm this unfortunate and unjust view that people have, if we simply singled out embryos of all of the things that shouldn't be patented. 

We didn't deal with human genes.  We didn't deal with property rights in genes, property rights in life forms, property rights in human beings.  We just chose human embryos.  I think it would confirm that impression in the public, and that's why I would oppose it.

PROF. WILSON:  I really disagree.  I think if we put in the preliminary phrases that lead up to this recommendation, clearly all the reasons why we're struggling with this question, and make it crystal clear that we are not taking a position that should lead anyone to believe that we're preoccupied with only one matter and not all matters, the press will—to the extent the press reads any of this, which I regard as having extremely low probability, I don't think we will be discredited in anyone's eyes.

CHAIRMAN KASS:  Charles.

DR. KRAUTHAMMER:  I basically wanted to say the same thing.  I'm sympathetic to your concerns, Michael.  But if, as you say, it would be a false charge, I don't think we ought to be deterred from doing what is the right thing to do by the fear that we're going to be handed a false charge.  If it's a false charge, we refute it. 

And I think the transcript—and if anybody fair-minded reads the transcript, they'll know this was not—that that charge is false, and the reasons that we deferred on the egg and the sperm, on the gamete issue, is because there are more uncertainties. 

It's a very simple proposition to defend what we do.  And if that's the case, you know, it's this ode in Washington—appearance of impropriety.  Well, either it's improper or it's not.  And if it's only appearance, you have to dispel it.

CHAIRMAN KASS:  Robby and Paul.

PROF. GEORGE:  Well, I must say I don't even see the appearance.  Two points.  If gamete patenting were water under the bridge, if it was yet another thing that already had been done, whether we liked it or not, we would still, if embryo patenting had not yet occurred, want to go on the record as opposing embryo patenting.

And the second point really just develops what Charles says a little bit, which is that on the question of embryo patenting we do have agreement.  On the question of gamete patenting, while many of us think that that should be something that's prohibited, others of us think that there are reasons perhaps at least not to do it.

Well, then, we have to consider that.  We don't have agreement.  It's a simple matter of not having agreement on this any more than we would have agreement on gene patenting or patenting of other things.

CHAIRMAN KASS:  Paul.

DR. MCHUGH:  Well, I think I've expressed myself before.  I like the wording originally.  I like the idea that we're talking about the seeds of human development as well as embryos.  I think we have an error in our biological programs that go back over 40 years. 

I think now is the time for us to say that we believe that these things are not good, and I accept Michael's idea that failing to do that would get us to be seen in only one particular way when this whole section was to talk about elements of human development that included the seeds.

And I would—I'm for—I can be—I will go along with the group in any way it wants to, but I think that we're giving up something that is important for us to say.

DR. KRAUTHAMMER:  Procedural suggestion—that we just put in the text exactly that, that we agree on embryos, and there are some of us who believe that this is a broader issue that should apply to all of the seeds of human procreation. 

Others have doubts mainly because of uncertainties about scientific issues, and because of that—and that alone—we defer on the second, but we make a recommendation on the first.  I think that would make this entire discussion explicit, and I think it would give the correct impression of how we came to our conclusion.

CHAIRMAN KASS:  I was about to say something like that, with an additional point.  And I think, by the way, since this is not simply at this point an attempt to plump down just a few postulate recommendations, but to surround them with text that reflects the spirit of the discussion, I think we could even talk about surrogacy or other sorts of things here and express our disquiet, but say we limit ourselves for the time being to those things on which there is now agreement.

And if this will satisfy, I'm perfectly happy—and indeed would like to propose for further discussion the larger question—to return to the larger question of the human body in commerce and of gene patenting, and those sorts of things.

So that, as I said earlier, simply saying this in this context shouldn't preclude—and I would like it not to preclude our going back to that topic and taking it up—use this as an entry into a larger topic on that score.  And we really take it up even looking at things that other people think may have been settled.

Shall we do that and see where—a couple of final comments, because we really do need to return to the other papers.

DR. MAY:  Yes.  I would just endorse that explanatory language, because I—you want to protect yourself against the kind of antinomianism of the law.  If this Council saw fit to say it was against this, carrying the implication that anything else goes, you don't want that.  That's one issue.

And the other issue is you don't want a misleading understanding of the motivation of the Council for sticking to this one thing.  And I think explanatory language would protect against both of those problems.

CHAIRMAN KASS:  We can do that.

Gil, did you want to—last comment.

PROF. MEILAENDER:  Well, once again, not everyone will want this to be the last comment.

CHAIRMAN KASS:  You have a right to withhold it.

PROF. MEILAENDER:  No, I—

(Laughter.)

—I do not wish to, because I'm not entirely satisfied—

DR. KRAUTHAMMER:  You have the right to remain silent.

PROF. MEILAENDER: —with where we are.

CHAIRMAN KASS:  Anything you say may be held against you.

(Laughter.)

PROF. MEILAENDER:  For instance, the prefatory language under four I am not satisfied with.  Indeed, it will have to be rewritten to satisfy me.  It cannot suggest something close to equivalence between gametes and embryos.

And if we get to the point where we're unwilling or unable to recognize that embryos, whatever precisely we think about them, do constitute a separate category, then we're going to have to start over on this document.

So I just think we need to be clear that we're either looking for some minimal consensus, or we're looking for some much more wide-ranging, full-blown view, and that will require a new product.

CHAIRMAN KASS:  Let me say, trust the staff—with my help—to satisfy everybody, or to die trying.

PROF. SANDEL:  Just to follow on Gil's—I think—I wouldn't say that we need necessarily to start over, because I'm assuming that there will be provision for dissent to be stated in these, for people who on all sides aren't prepared to accept all of the provisions.

PROF. MEILAENDER:  All I meant was that if we're looking for some fuller blown understanding, we're going to go back to the first three categories as well.

CHAIRMAN KASS:  Let me declare this—Bill, is that a hand?  No.  We are at 20 of 10:00.  Let's take until five of 10:00.  We'll reconvene and do the paper—we'll start on those next two papers.

      (Whereupon, the proceedings in the foregoing matter went off the record at 9:40 a.m. and went back on the record at 10:07 a.m.)

SESSION 6: STEM CELLS: RECENT DEVELOPMENTS (SCIENCE AND ETHICS)

CHAIRMAN KASS:  All right.  We now move from the biotechnology and public policy project to the monitoring stem cell project.  And this session we really have two staff working papers that we will review.

The first is the ethical debates reviewed, and let me remind everybody just very briefly what we're doing and what is this project.  We have been charged, and we are carrying out that charge, to monitor stem cell research in the light of the current federal policy.

The task has basically three parts.  First, a clear presentation of that policy and its legal and ethical underpinnings to provide a correct picture of the umbrella under which the activities take place.  A first draft of that was discussed at the last meeting.  It was not meant to be a defense, but simply an explication of the policy as we understand it.  There were criticisms offered, and that—that document is being reworked.

Second, a monitoring of recent developments and moral argumentation, as addressed to the moral, ethical, and legal legs of the current policy.  And, third, a monitoring of recent developments in stem cell research and clinical application, adult and embryonic, publicly funded and privately funded.

These three parts will be the basis of the shape of our report.  After an introductory chapter, a clear presentation of the policy and its legal and ethical underpinnings, Chapter 2.  Chapter 3, recent developments in the ethical debates.  And Chapter 4, recent developments in stem cell research.

As this is a Bioethics Council, the first point of monitoring is ethical, not scientific medical.  The first question is:  how sound are the moral, legal, and ethical legs of this policy?  And that is the topic of—that's why the discussion of ethics here is going to precede the discussion of science.

We, unlike other people who are engaged in this debate, and who are engaged in it because they have interests that they are seeking to defend, that they want what they want and they will lobby until they get it, or they don't want what they don't want and they will lobby to continue to oppose it.  Our task here as an ethics council really is primarily to consider what is the right and what are the good things to do.

And we either could argue this through for ourselves, although our opinions are as divided as the opinions out there, or we will do what has—what we have decided to do here, namely to prepare a working paper working toward a chapter that in fact is a review of the current state of ethical argumentation pertinent to the policy.

And that is a very thorough staff paper with—based upon a very thorough review of the literature over the last couple of years is—is before you in Tab 9, "Monitoring Stem Cell Research:  The Ethical Debates Reviewed."

And I will read the paragraph on the first page of it.  While we—well, what this paper does is outline the general form of the moral argument, noting that although other issues are certainly also in play, the central issue is often turned on the moral standing of the human embryo.  Footnote to be discussed in a moment.

Second, we will discuss the specific questions and critiques regarding the administration's policy as these have emerged in public discussion.  And we will have a continued discussion, too—of the moral standing of the human embryos, seeking again to outline the chief fault lines in that continuing debate.

"While we will raise these arguments and counterarguments, problems, questions, and concerns, our purpose in this paper is not finally to access the validity of the competing claims and to arrive at a conclusion, but — in line with the charge to monitor developments in this area — to present them more or less as they have appeared in the public debates of the past several years.

"This way of proceeding has one especially prominent drawback: it tends to present all arguments as equivalent in their importance and prevalence.  We will seek to avoid this whenever possible and to offer some sense of which have been the key components of the public debate."

Now, I think that lays out fairly clearly what the style and the spirit of the document is.  The outline is, first of all, some interesting remarks on the nature of the moral argument, a series of—a discussion of the series of principles that are the moral bases of policy, the relief of suffering, freedom of research, and the moral status of the human embryo.

Then, arguments that bear on the character of the policy, whether it's arbitrary, whether it's unsustainable, or whether or not it's inconsistent.  And then, in the larger section, discussions of the moral status of the embryo with discussions about continuity and discontinuity, and then a whole series of special cases and exceptions, the IVF spares, the point about natural embryo loss, the question of prediction of non-viability, and the creation of possibly non-viable embryos, artifacts that might avoid this problem altogether.

I think this is not the session for line editing and going carefully through this.  This is well on its way I think to being the guts of a possible chapter.  And I think what's—what I and the staff need to know from you is your overall impression about the approach and the way of proceeding, whether there are important matters left out, whether there are important issues misdescribed in the language that we should be more sensitive to, and just get your general sense about the document as a whole.  Obviously, corrections in detail in writing to the staff would be most welcome.

I would like to ask, since Alfonso prepared a memo which some of you were able to get when I handed it out last night, but for anybody who didn't get a copy of Alfonso's memo, there are extra copies here.  Elizabeth probably didn't get this.  Anyone else need a copy?

Alfonso has a number of things here, some of which have to do precisely with the language, both of moral status and of the human embryo. 

And perhaps, Alfonso, if you wouldn't mind—I don't want to put you on the spot.  But if you'd like to, for the moment at least, deal not so much with your attempt to offer the proof or the conclusion, but simply deal with the linguistic points.  So that—

DR. GÓMEZ-LOBO:  Okay.  I'd be happy to do both.

(Laughter.)

CHAIRMAN KASS:  Feel free.

DR. GÓMEZ-LOBO:  No.  Really, the purpose of this memo was precisely as I said, that it might save us some time.  So let me mention the linguistic point for a moment, and then, if you're patient enough, I'd like to have at least one shot at the—at a critical discussion of a concept that has played a huge role in the Council it seems to me—the idea of an intermediate status.

And I think it's an untenable concept.  That's why I think it makes sense for me to make some critical remarks.

Now, the linguistic point is—that I see is this.  Namely, that it has become a fashion maybe for a decade or less to talk about these things in terms of moral status.  Earlier writers talked about moral standing, but now almost everybody discusses it in terms of moral status.

And I think it's a very misleading expression, and expressions easily divert our attention or mislead us into directions we don't want to go.  And what I do here is I call attention to the following—that when we think about status we have some model or other.  I mean, we don't think in the abstract. 

And a possible model is immigration status.  Maybe it's because I had to deal with it for many years that I'm familiar with it.  And there are two misleading things about it, and, believe it or not, it appears many times in the literature.  Namely, the idea that status is something that is granted.

Many writers talk and say, "Oh, we grant status to the fetus, or we grant status to the child," etcetera.  And I find this misleading, because if anything this should be a property that something has, not something that we arbitrarily assign or not assign.

I'm not complaining about the Immigration Service.  They have all the right in the world to assign a status, and it's an administrative decision.  But we should not be making decisions about a certain category of beings.  So that's number one what I find misleading about the expression.

The second thing that is misleading in this expression is that there can be immigration status of different kinds.  You can either be a temporary worker or you can be a resident alien or you can be a foreign scholar.  I mean, if you've dealt with the INS, you know what I'm talking about.

And the problem, then, is that this suggests that there might be different kinds of moral status, and that's where the other problem comes in, that there might be something called full moral status or non-full moral status or intermediate moral status.

And that that is—now we're going into substantive arguments, if I cross the line here—if I may cross the line.  But that's also a misleading feature.  If I ask myself, well, what is the—how has philosophy considered moral status in the past?  Well, it has considered it under the rubric of dignity, and the question has been, well, does this object have dignity or does not have it?

Now this sounds a little bit harsh in terms of saying, oh, this is, you know, a very harsh dividing line.  But I think it is—I think it is a very strict dividing line for the following reason.

Traditionally, the idea of dignity entails that you may not intentionally destroy that being, or subject that being to instrumental use.  Period.  In other words, to assign dignity, or Kant calls it the value of persons, is to say that there is a being that is off limits for any calculation for any balancing.

Innocent human beings should not be made an instrument, no matter how noble the goals.  That I think is the traditional idea, and it—to me it makes a lot of sense, because I think that I can claim dignity for myself and that I have to respect all of you, because you have dignity.

Now, to the substantive point, is it true that there can be an intermediate moral status?  And to introduce my criticism, I'd like to make an analogy with the idea of human rights.  Now, for instance, I'm sure we all acknowledge the right of defendants not to be tortured. 

And if we say, well, let's create an intermediate category, the category of those individuals who sometimes may be tortured to obtain confessions, let's say if there is tremendous threat coming from whatever they have done.  And someone might say, "Well, this is an intermediate status, because we're not saying that all defendants should be allowed to be tortured, but only this category of defendants."

Now, if we do that, we're not really creating an intermediate position, but we are really denying the basic human right to that category of people.  And this is for logical reasons, because the contradictory of all is not none, but not some.

So, in other words, it's very important to realize that we're talking about a property which on the one hand is the contradictory of the assignment of human dignity, to say of any category of beings that they can be destroyed under certain circumstances is simply to deny dignity, not to say that they have less dignity.  That's the point I'm trying to make.

Now, of course the next question is fully an ontological question.  It's a question of how things are, not a moral question.  Namely, what is our relationship to human embryos?  And what I do in this memo is try to argue as simply as I can that there is a connection of sameness.  Namely, that there is continuity, but there is, above all, biological sameness guaranteed or proven, let's say, by sameness in DNA.

And that's why in the courts today DNA is used commonly to prove identity or not identity between the defendant and the person who committed the crime last month.

And then, I go on to say, well, it's not that we are only our genomes, but our genome is a sufficient indication that we have been the same biological individual through time.

Now, of course, there is the question of twins and—because twins do have the same DNA.  But in that case, spatial-temporal continuity can be applied, and the alibi idea in the law has to do with that.  It's to say I cannot be the killer or the criminal, because I was physically someplace else.

In other words, if you trace me in space and time back to that moment, I'm not going to coincide with this person.

Now, that's very sketchy.  But I wanted to have a chance to put it forward, because so much hangs on this idea of an intermediate moral status that at least we should think about it, it seems to me.

Now, the final point would be this—that to assign intermediate moral status really entails contradictory moral commands, because it seems to imply on the one hand that you may morally destroy something.  But on the other hand, since it's intermediate, it's not an all-out predicate.  You have reasons to protect that being.

And, of course, we cannot act on the basis of imperative that bids us to do contradictory things.  So those are, you know, in very short summary, some of the key ideas.

CHAIRMAN KASS:  Bill May.

DR. MAY:  I feel Alfonso is presenting his credo, not directly commenting on the debate of the last couple of years.  And apparently, this paper is attempting to describe the debate of the last couple of years.

I don't mean to criticize Alfonso by saying that, because as a matter or fact, is it possible to say that this paper is not simply a description but in part an interpretation of the debate?  In which case I have a few comments to make about it, and about the nature of moral argument as it is described here, and—

CHAIRMAN KASS:  Let me make—let me sort of make the procedural point, so we know what we're doing.

DR. MAY:  Yes.

CHAIRMAN KASS:  And I would I think concur, Bill, with your first sense that that's probably why when I asked Alfonso to speak to begin with the—there are two parts in his memo.  I mean, one has to do with the language of moral status and, although he didn't comment on it, the human embryo.  In fact, the whole title of that subsection reads, "The Moral Status of the Human Embryo."  And Alfonso calls our attention to the problematic character of both of those expressions.

If there are terms that are problematic, we at least who are propagating those—promulgating those terms in this report should know about it, and at least should call attention to the difficulty.  The linguistic point, therefore, addresses us as a Council drafting and describing this field.

The substantive argument which he then tries to make is, it seems to me, unless it's meant to say he is trying to put forth an argument that ought to move this Council to a uniform conclusion about it, it is out of line in the sense that it is not a comment on the document, though now that it's a matter of the public record the revision of this document can include that argument as part of a critique of that—of the intermediate moral status view.  And we'd be happy to add.

So I would say that I take very seriously the terminological thing as a warning for us.  I take very seriously the moral argument as something to be added to the document.  And if there are other things of that sort where important moral positions are not properly developed here, we should have it.  Or if there are misperceptions or misrepresentations of the debate, we should have that as well.

But this is, I think, not the place to argue out, at least not today, to try to argue out who is right and who is wrong on the question of the—on the question—and whatever I'm going to say is going to be—on the question.

I'm going to restrain myself, Alfonso, from enjoying a substantive argument with you.  If there's time, we'll do it later.

Bill, take the floor.

DR. MAY:  The document, at the very outset, relies heavily on the contrast between two metaphors—shaping moral reflection on stem cell research, metaphor-weighing or balancing various contending values or interests, and, in effect, the metaphor of trumping other values by appeal to an overriding and unexceptionable principle that demands  the protection of a particular value such as the human embryo, even against actions that might seem to realize important values.

Those who hold the latter view, as I understand it in this description, would see it as inappropriate simply to think of the human embryo as one more value to be placed on a scale of competing values.

The document, as it describes the debate, tends to associate the word "principle" with the unexceptionable as opposed to weighing and balancing in which it "may not really be clear how this balancing actually takes place, and it may not be obvious that there is any scale on which the various values can really be weighed."

Thus, the document refrains from describing weighers and balancers as principle-oriented in their ethics.  I sense in these remarks the worry that unless one holds to a principle as unexceptionable, one slides down the slope into the relative.

The document doesn't leave much room for pluralists and their thinking about issues and ethics—those for whom duties are plural, and, therefore, recognize that duties may sometimes conflict.  Such pluralism differs from both relativism and absolutism, perhaps more than absolutism and relativism differ from one another.

On the face of it, absolutists and relativists seem irreconcilably opposed.  Absolutists agree—argue that the validity of a principle depends upon its universality.  There can be no exceptions.  Relativists have discovered exceptions, and, therefore, deny the principle. 

At a deeper level, however, absolutists and relativists agree.  Both subscribe to the view that the validity of a principle depends upon its universality.  The value of a good, the heft of a principle, depends upon its supremacy, its overridingness in all circumstances.

Neither has discovered the wisdom of the ancient observation that moral principles/laws are true for the most part.  "For the most part" is not a loophole in and through which one escapes into the sea of the relative.  They are true for the most part in the sense that they reach their territorial limit in those cases where they must yield to another principle or good.  The more stringent, the more urgent in a particular case.

Further, even in that yielding, the original principle does not simply vanish.  It maintains pressure upon one, and how one pursues the supervening good, and it generates in some cases duties of reparation and gratitude for losses imposed and benefits received.  Such is the rough landscape of policy-making in which one may need to compromise, not in the sense of defecting from duty but honoring duties which are multiple.

CHAIRMAN KASS:  That's a beautiful statement, Bill, and I think—I won't even allow any objections.

(Laughter.)

I mean, I think the document has to include that as—as at least true of some people in this moral debate.  Wait a minute.

PROF. GEORGE:  But as with all views presented, the counterarguments will be presented as well.

CHAIRMAN KASS:  Well, no, no, just a minute.  You want to say something to that?

PROF. GEORGE:  We can have the debate now, if you'd like, or—

CHAIRMAN KASS:  Just to that.

PROF. GEORGE:  Yes, okay.  What are some examples of fully-specified conflicting duties?

DR. MAY:  Well, you ask for an example.  I spent a weekend at an institution for retarded folk, when I was in a chair at the Kennedy Institute of Ethics.  And the folks that ran that taught us wrestling holds that they use with the retarded, some of whom on special occasions their difficulties take the form of doing damage to themselves or damage to others.

And they have a basic commitment, of course, to liberty in how they treat people there.  On the other hand, when they're doing damage to others or themselves, the tendency of course is to toss them in the slammer or put them in a straitjacket, and then you turn away from them and to other things.

And by teaching them wrestling holds, they pointed out to the staff members—in effect, they teach them how to make a straitjacket out of the body of the retarded person, holding them by the wrists behind their back.  And it guarantees that people will not hold them any longer than is necessary, whereas if they are in a straitjacket they are put on hold and forgotten.

Now, there you have two duties that run into some tension with one another—the duty to protect people from harm; on the other hand, the duty to honor liberty.  And at that moment, the duty to honor liberty yields to the duty to protect.  But it doesn't simply vanish; it affects how you protect, and that you don't impose the curtailment of liberty any longer than is necessary, and so forth.

And as I went through that experience with those two women who were teaching me those holds, I realized what a lovely parable it was for the difference between the tyrant or simply the person seizing power who takes the excuse of the crisis for imposing restrictions and doesn't think through you do the least restriction possible for as short as possible a time, and so forth, only when it is a last resort.

Now, it's that kind of specification that I think is important.  And you don't have an absolute that trumps in any and all circumstances.  And if it fails to trump, then quickly things unravel into the relative.  That would be one illustration.

CHAIRMAN KASS:  Do you want a very quick -

PROF. GEORGE:  Yes.  This—

CHAIRMAN KASS:  Not a long—

PROF. GEORGE:  Okay.  This may be, you know, a difference in the way two different schools of philosophical analysis approach a problem.  I think we'd come to the same conclusion, but—in this particular case as to what ought to be done. 

But I certainly wouldn't want to analyze it in terms of conflicts of duties, because once we have the circumstances and the norms that apply fully specified, I think that we see we have a particular duty here.  There's not a competing duty.  There are various principles, there are values, that are at stake here that have got to be honored.

But at the end of the day, the duty is to protect the child.  The duty is to do what is in the best interest of the child.  Sometimes that will require respecting the child's liberty, and in that case we can talk about a duty to respect.  When fully specified, that's the conclusion to the normative syllogism.

In other cases, we'll say that our duty is to restrain the child, not to respect the child's liberty.  It's not that it conflicts with the duty of liberty.

DR. MAY:  You're talking about actual duties.  But it seems to me the language of the description of the debate tends to suggest that either you have unexceptionable principles or you are engaged in a weighing and balancing, and that's a very slippery thing. 

And I try to suggest ways in which one simply doesn't have the alternative, engaging in a weighing and balancing that lacks any sense of principle.  And the one sentence that I quoted I thought moved in that direction.

CHAIRMAN KASS:  Gil.

PROF. MEILAENDER:  These are complicated matters, though.  I'd have to look back at exactly what the document says.  But the—and I actually would come at it in—Robby has a particular system out of which he comes at it, and I would come at it in a little different way.

But the question is not whether all duties are without exceptions, and you're just stuck when they clash.  The question is how you resolve circumstances in which you appear to have competing duties.

And there are ways of resolving them through building in exception clauses, or through lexical rankings, and so forth, that do not involve weighing and balancing.  The question is whether the competing duties are—what seems to be the competition between the duties is resolved by some sort of weighing and balancing of consequences or not.

That I took to be the alternative, and I don't think I—I suspect that, Bill, your description would not necessarily want to suggest that the—this clash between prima facie duties is resolved by weighing and balancing.  But there are various ways to do it, and they do not have to involve a turn to a metaphor like weighing or balancing.

CHAIRMAN KASS:  Rebecca.

PROF. DRESSER:  This is related, to some extent—I didn't see anything in this document discussing the special respect position and how—the implication seems to be if the special respect position is taken, then there is no scrutiny of the reason why embryos are going to be used and stem cells are going to be taken.

But within the—I think some of the argument that's going on in our culture today is, what does special respect mean?  And so a system that builds on that view could be more or less restrictive.  There's a lot of room in there.  And so it shouldn't be seen as, well, unless you adopt the view that the embryo is equal to the born person, then there's no scrutiny at all.  And so it seems to me it should at least be acknowledged that there is room—

CHAIRMAN KASS:  There should be a richer presentation of that, yes.

PROF. DRESSER: —and we're not sure where to go with it.

CHAIRMAN KASS:  Very good on that, yes.  I mean, we will do that, and we will also incorporate something of Alfonso's view that the doctrine is altogether incoherent.

DR. GÓMEZ-LOBO:  Yes.  That was my request.  Well, let's do it.  I mean, let's see what that special respect entails, because I—my own feeling is, once we get down to it, something similar to these other cases is going to have—

CHAIRMAN KASS:  Rebecca, if you'd like to—I don't want to lay any work on you.  But if you give us a paragraph or two as to how that would look, and you'll send it to him, and vice versa.

Elizabeth, please.

PROF. BLACKBURN:  I was thinking about the second part of what Alfonso had presented, and the argument about same DNA providing a reasonable criterion for biological sameness and the recognition of sameness.  And I think this really pertains very much to the discussions about cloning that we had earlier, which is the issue that if one does have an adult cell which has, of course, the DNA in it that will become the same DNA in the, say, cloned blastocyst for producing stem cells for biomedical research.

For example, and that's the same DNA, and then one has to get very arbitrary as one considers the DNA in, say, the adult skin cell that is used for the source of what gets put into the enucleated oocyte—or egg, sorry, and then into, say, a cloned blastocyst.

And so, really, it's very hard for me on any sound basis to say suddenly something magical happened during any of those particular steps.

CHAIRMAN KASS:  I'm sorry.  During?

PROF. BLACKBURN:  During the steps of the skin cell genetic material, DNA, going through the process of an enucleated egg, and then becoming a blastocyst. 

So I think that there's a problem in that argument, and what it would—the corollary of it is that if we don't think an adult skin cell is anything special, then I don't think it—you know, then a cloned blastocyst, by logic, is equally not something—it hasn't created a new genotype that's unique to that individual.  It's simply the old genotype of the original donor of the cell.

So I think that's just a logical corollary of this argument, and it does take us back to the—

DR. GÓMEZ-LOBO:  Can I add something briefly?  My claim is that the DNA provides one criterion for sameness of an organism.  I mean, surely we don't want to say that the skin cell is an organism, right?

PROF. BLACKBURN:  Well, I think there's a continuity where it's very hard to suddenly say something happened at what moment.  So I think there's a real difficulty in the continuity, and it's very hard to say suddenly something happened.

DR. GÓMEZ-LOBO:  Well, I've been listening.  Scientists tell me that something very important happens when you have the syngamy in the case of natural fertilization or this reprogramming in the case of selective cell transfer.

PROF. BLACKBURN:  Yes.  And that's a continuous process.  It's not in a sudden moment.  It's a continual unfolding saga of events.  The reprogramming is a continuing event.  And I think it—and I think we also in that line—the potential of this, which is the other kind of nature of the argument is, you know, as Rudy Jaenisch very clearly pointed out, this does not have the potential to produce a normal individual, and as we've discussed in the line of the clonote.

So I think that, logically speaking, one could come to the conclusion that the clonote is, you know, no more of an individual than the skin cell.

DR. KRAUTHAMMER:  But our experience is that a continual process does end in a discontinuity named Dolly.  So you end with a discontinuity with another being.  We can argue about when the continuous process—

PROF. BLACKBURN:  Yes.  I was really arguing for cloning to produce blastocysts, and not for going on to reproductive cloning.  I'm not arguing that one should go forward to reproductive cloning.

DR. KRAUTHAMMER:  All right.  But at some point you recognize that that process, which you call continuous, if allowed to continue results in a discontinuity.

PROF. BLACKBURN:  If allowed to go to reproductive cloning.

DR. KRAUTHAMMER:  Right.

PROF. BLACKBURN:  Yes.  No, I really was confining what I wanted to talk about—

DR. KRAUTHAMMER:  Okay.

PROF. BLACKBURN: —to the idea of producing blastocysts, the biomedical stem cell research issue.

CHAIRMAN KASS:  Well, I'll subside on this.  We could discuss this further, Elizabeth, but I don't think—there's a question about whether continuous biological processes, they don't also result in some kind of novelty at a certain point.  Whether you then go on to use the cells for research or not would be a separate and additional question.

PROF. BLACKBURN:  But the DNA is the prime source I think Alfonso is raising, and I'm saying it's one in the same DNA.  That's all.

DR. GÓMEZ-LOBO:  But this is just—I'm just saying this is just a criteria to judge sameness across time of a given kind of organism.

CHAIRMAN KASS:  But the sameness of DNA is not the—is—

DR. GÓMEZ-LOBO:  Is an indicator.

CHAIRMAN KASS:  It's an indicator, but it's not the sufficient criteria of what you're talking about.

DR. GÓMEZ-LOBO:  No.  No, indeed.  And then, the interpretation of what Rudy Jaenisch said, I mean, maybe this is not the point to discuss it, but -

CHAIRMAN KASS:  And he didn't say absolutely.  He said almost.  I mean, there were qualifications in there, and he certainly can't know for certain that we won't get a Dolly—you know, a Dolly on—

PROF. BLACKBURN:  If one does an implantation into a womb—

CHAIRMAN KASS:  Yes, sure.

PROF. BLACKBURN: —I mean, it takes a lot more than just—

CHAIRMAN KASS:  Let's leave this alone and go on.

Gil.

PROF. MEILAENDER:  Yes.  Interesting as these things are, I did take it that the purpose of this paper was not to argue the moral question.

CHAIRMAN KASS:  Correct.

PROF. MEILAENDER:  But to try to outline the argument.  And I just wanted to make two comments with respect to that.

One is just taking the document as it is, one comment about its structure.  I think it's—and I'm not sure I'm right about this, but it seems to me that it's peculiar to find the discussion of IVF spares at the point in the document where we find it.

The point in the document where we find it is within the discussion of the embryo and the disagreements about the embryo, because the thrust of the document has been to say it just turns out that that's where people disagree, and so we're going to discuss the embryo.

But the IVF spares are embryos.  It's just another case of the same disagreement appearing.  If you think that those embryos are human subjects, possibly even dying human subjects, you think they should be treated in one way.  And if you think they're not, they should be treated in a different way. 

So it seems to me that the spare issue should—it's not that it shouldn't be discussed, but it shouldn't be discussed—we should find a different place in the document for it.  That's my -

CHAIRMAN KASS:  I'm not sure I understand the nature of the objection to its location.

PROF. MEILAENDER:  Well, it's not—the discussion of the embryo is a discussion about all of the different points at which people have suggested that there is a moment of discontinuity that might be thought of as a beginning point.

But that's not the issue with the IVF spare.  The issue with the IVF spare is kind of, what should you do with this thing, whatever you happen to think about it.  It just seems to me it's a different question, and it's mislocated.

CHAIRMAN KASS:  But it's—well, rather than argue it through here, let's—we will take that up, but—

PROF. MEILAENDER:  Yes, I'm—in fact, it's not something I'm going to go to the wall for or anything.  It's just a suggestion.

CHAIRMAN KASS:  Okay.

PROF. MEILAENDER:  The other thing is—and this is just a comment, and I'd—and if anybody—anyone else has views on it, I'd be interested in hearing—if you're trying to summarize the debate, I admit I have a hard time thinking of other or better ways to do it than the way the draft document does.  But there is a kind of dizzy quality to it, you know.

Some say—critics say this.  You know, you're sort of back and forth, back and forth.  I'm not sure how good a read it is in a certain sense.  I don't have a particularly good alternative to offer, but I just wanted to sort of note that in case others shared the view and I could trigger a better suggestion.

As I say, there may be no better way to do it.  I'm perfectly prepared to accept that possibility.  But there is just sort of a swaying to and fro quality to it that at some point is dizzying I think.

CHAIRMAN KASS:  Do you want to respond to that?

PROF. DRESSER:  A little.  I wanted to—if I were a teacher marking this up, I think it needs some more head—clearer headings and topic sentences and thesis paragraphs.

CHAIRMAN KASS:  Right.

PROF. DRESSER:  I did have a sense as I was reading through that it wasn't as easy to follow as we would like our—but I assumed that that would be cleared up.

CHAIRMAN KASS:  Yes, we will work on that.  But could we deal head on with Gil's suggestion that, you know, this is—it's partly an attempt to be faithful to the argument without ourselves taking sides, which produce—and it is—we will try I think to not simply treat everything as equal to—every argument as equal importance to everything else.  So we'll give some kind of emphasis.

But we are going to be stuck with on the one hand and on the other, and, as Gil says, he hasn't—he doesn't yet have a suggestion for how to do this better.  The alternative, of course, is on the one hand, on the other we say—I mean, you know, the method of Aquinas. 

But I think I've been in this room long enough to know that we say on the one hand—

(Laughter.)

—therefore, we do a kind of service.  And by the way, this, I'd be willing to say with your consent, that at the end of the day, after having laid this out one side or the other, one of the things I think we can say is that if anybody thinks that this debate has now resolved itself so that we can sort of settle this question once and for all, and pronounce that this side is victorious, they are mistaken.

No one, it seems to me, with a fair reading of this—and I think this is not a bad conclusion to set forth as monitoring the argument.  The argument has gone on before the President's decision, it continues to go on, it will go on from here forward. 

But we don't find anything at this point that would lead someone to be able to say that decision is—conclusively that that decision is wrong, or to say conclusively to the contrary—in other words, that—to indicate that this—that what we've done here leads to a certain kind of conclusion.

Now maybe—I see there are people reaching for their electronic equivalent of revolvers to shoot down that suggestion.

(Laughter.)

So let's have it.

PROF. MEILAENDER:  Well, what would that mean, if we said that would—would that mean that none of us was persuaded that one of the arguments was good enough that somebody should adopt it?  I mean, that would seem to be a peculiar place to arrive.

CHAIRMAN KASS:  Yes, okay.  One bullet.

Does someone want to respond to the question of the form?  I mean, it's a problem I think to do other than what we've done.

Jim.

PROF. WILSON:  I think—I'm not certain about this—that we're reduced to a choice between two forms.  Form A would be people on one side of the issue, assuming we can identify clearly two sides, possibly there are three, stating at length all of their arguments.  And the people on the other side, or possibly a third side, stating at length all of their arguments, and we put it together.

The disadvantage of that process is that the arguments on each side will not be fully met.  And we will be forbidden in effect from correcting the language of the side we're not on, because it is, after all, their side.   And, therefore, the value of this document, which I think is very large, will be lost.

The other way is to say here, with respect to each stage, are a series of arguments, and here are their corresponding rejoinders matched up as accurately as we can possibly make it, subject to review and criticism by all of us.  This gives the kind of seesaw quality to it, which I think is:  a) inevitable, and b) desirable.

CHAIRMAN KASS:  Robby.

PROF. GEORGE:  Leon, one of the questions that has interested me as we've touched on issues in this debate over the time the Council has been in existence is the question of where our disagreements are.  And I think that this paper is useful in clarifying that.

But there is one area in which I'm still not quite sure whether we have disagreements, and that is the area of embryology and early human development itself.  I'm not sure to what extent our disagreements presuppose a common understanding of embryogenesis and to what extent there is actually dispute.

Michael Sandel and I had occasion to debate this issue of the standing of the embryo at the American Political Science Association.  And I thought it was very—a very useful debate, because we were able to pinpoint where our disagreement was because we did agree on the underlying embryological facts.  And then we got to a point of moral disagreement or the interpretation of those facts in view of moral principles.

But I'm not sure in every case whether there is that agreement.  I'm not sure if Dr.—if Mike Gazzaniga would agree with me or with Michael Sandel on the embryological facts.  There have been things that he said in the course of our deliberations that leads me to think that there might be a disagreement there.  That's not addressed here, and I wonder if it could be.

CHAIRMAN KASS:  Okay.  We have two choices here.  We've got three choices—A, B, and A plus B.  A would be to explicitly introduce into the discussion, although it's tacitly here on the question of continuity and discontinuity, we come close to the question about what the truth of the embryological situation is.  But we could add a section here to indicate that there might be arguments on the embryological facts.

I mean, Michael I think was—Michael Gazzaniga was exaggerating rather luridly to make a point in a very early meeting when he declared the early embryo to be the equivalent of lumber at Home Depot, or something like that.  I don't think if—I don't think if he was going to write a dissent to this document he would sort of describe it that way.

But alternative B is already in the works, which is we have an appendix to this, which is a kind of little primer on the embryo.  That is to say, what thoughtful citizens should know about the embryo, so that they can actually enter into this discussion.

And that's partly embryological facts and partly shaped in a certain kind of narrative way, so that we're not simply going to—so that's B.  We could do both.

PROF. GEORGE:  Well, if there's actually not differences of opinion that are significant, then I suppose it's not critical that it be up front.  If there are—

CHAIRMAN KASS:  Well, why don't we try -

PROF. GEORGE: —it would be more important.

CHAIRMAN KASS:  Well, it's, it seems to me, less important amongst us, then, to see what's in the literature on this question.  And we can certainly—we can be in touch with Mike Gazzaniga to see if he wants to make an issue out of that as a comment on this.

PROF. GEORGE:  In fact, maybe it would be good to check with others who—with Janet and others who aren't here, just to see whether that's an area where we do have disagreement or not.

CHAIRMAN KASS:  Yes.  Okay.  Will do.

Rebecca, please.

PROF. DRESSER:  I would prefer and favor the approach that this takes of working through arguments rather than one side versus the other side, because I do not think there are two sides and sort of a split on one issue.  I think there are lots of complicated things to think about, and I would rather explore this discussion in its richness.

On that note, on the second-to-the-last page, 26, it mentions—this is the catch-all where all of these other considerations are mentioned.  I would like to add that toward the bottom it's talking about the discussion on the likelihood of cures, and so forth.

To me that concern is tied to the principle of truth-telling.  That is, we should discuss this research in a way that is reasonably accurate, and just as we are—we have decided we should tell patients the truth about a depressing prognosis, in a sensitive way we should also tell people the truth about the status—not the status, the preliminary nature of this research.

So I'd just like to see it tied to a broader principle of truth-telling, which I think is important in medical ethics and science ethics.

And then, the one right below there, the disproportionate emphasis is tied to justice considerations and priority setting and some of the things that Dan Callahan has written so well about.  So, again, there is a broader concept and ethical consideration that I'd like to tie these points to.

CHAIRMAN KASS:  Excellent.  We will do that, and we'll consult with you on how to do it, and to do it well.

I take it from the discussion that there's a general endorsement of the form, recognizing its limitations, and that we will, in fact, make it clear that we—maybe even make it more explicit why we've chosen this form, and also provide the kind of more helpful structure to help the reader through this on the one hand on the other, and reconsider the placement of the spare embryo question, take into account Bill's very rich discussion.

Am I leaving out—take into account Alfonso's concerns on the terminology, make at least—in fact, make—have a discussion here rather explicitly on terminology, which we haven't so far done, and add the exchange between the special respect and the response on the special respect to fill out that discussion to make this a richer and truer account.

Robby, anything else? 

As you can see, I'm trying to—I mean, there are large things, we should have them.  If they're editorial things, we'll get them in writing.  But I'd like to move on to the other paper, so that we can get through the meeting.

PROF. GEORGE:  Leon, if I can just hold us one more minute on—

CHAIRMAN KASS:  Please.

PROF. GEORGE: —this paper.  Section 4(d) raises the issue which Bill Hurlbut brought to our attention in his statement.  This is page -

CHAIRMAN KASS:  24.

PROF. GEORGE: —24, which Bill brought to our attention as a possibility in his statement attached to our cloning report.  This I think is of particular relevance.  It's something that those of us who take the high view of the standing—of the embryo are really interested in.  Some of us—of course, some members of the Council believe that embryo experimentation, under certain circumstances at least, is morally acceptable. 

But those of us who don't think that, or at least don't think that we should pursue research involving the destruction of embryos, wonder whether there may be a way out of this dilemma by the creation of entities possessing a human genome and capable of yielding useful material, such as embryonic stem cells, but which lack features which would lead us to conclude that these are human beings in the early stage of development, strictly speaking human embryos.

I think it's great that it is taken up in this paper, but it's at a very early stage of discussion.  And I have a concern that just the way it's presented here it may suggest that what those of us who are interested in this are interested in is the creation of embryos that are then interfered with in a way to ensure their early aborting, or something like that.

Now that's not actually what those of us who are interested in this are interested in.  We're interested, rather, in the creation ab initio—the possible—of a possible entity, which would, by our account, not in fact be a human being.  I think this is a very worthy thing to explore, but I would be happy if we could work with the staff—

CHAIRMAN KASS:  We'd be happy to put this language in the form that is acceptable.

PROF. GEORGE:  Great.

CHAIRMAN KASS:  Are we all right on this?  Michael, is that—

PROF. SANDEL:  Well, this is a possible alternative structure, but it may not be a good idea.  It may be that we should just give a catalog of the arguments on both sides.  But if we wanted to have a more focused paper that probably would have more of an impact certainly within bioethics—I don't know whether the public would pay attention or not.

There are really two interesting questions, two interesting philosophical questions posed by this issue.  One of them is the one that Alfonso raised, the moral status and the moral standing of the embryo, and that debate.  The other one is the question of the relation between one's view about the moral status or standing of the embryo to policy, and specifically the question raised by Peter Berkowitz's commissioned paper for the Council, whether if Alfonso is right about the moral standing of the embryo, is it a defensible position to ban the funding, never mind the timing and the date, to ban the public funding but to permit the private use of stem cells. 

That's an interesting question, without getting into—but it's also a question on which there may be agreement—there might be controversy about that, but the controversy would probably not cut along the familiar lines defined by the first question.  In fact, I suspect that Alfonso and I would probably be on the same side of that second question, and that I think would be—we got a little bit into that when we were discussing Peter Berkowitz's paper.

And so one way of making a contribution of a more pointed, distinctive kind, rather than cataloging all of the arguments on one hand on the other, would be to take that central issue as the question, to argue it out, and to look at the arguments on both sides about that, about the relation between one's view of the moral status or standing of the embryo, and a policy that would prohibit the use of federal funding but would permit the practice with private funding.

CHAIRMAN KASS:  Alfonso, do you want to respond?

DR. GÓMEZ-LOBO:  Yes, very briefly.  I think that's a very important question.  But, of course, the other one is the prior one.  I mean, unless you philosophically—

PROF. SANDEL:  We'll do both.  So a document that sort of reflected—and we would have to hash out both.  Here we could draw to some extent on what we've already done, and that would be—that's the interesting bioethical, philosophical—those are the two interesting questions.

CHAIRMAN KASS:  I'm not sure whether, without thinking about it, I want to concede that those are the two interesting, you know, questions.  But my sense is that:  a) we have a certain interest in getting this document out before the science that it is based upon is simply superseded. 

And I also think that we do do a service in the way of monitoring the debate to organize it.  I mean, to really—the literature has been widely combed and covered.  We've organized it I think in a very helpful way, however incomplete and however much it could be enriched.  And, you know, one owes people an account of, you know, what the live issues still are, maybe giving some greater emphasis, and perhaps, Michael, adding the point that you raised.

Peter Berkowitz's paper will be in the appendix as one of the papers that was prepared for this project.  And if you or someone else would be interested in—that would be a place to do this, to have a kind of additional paper on the second subject.

PROF. DRESSER:  Wasn't the staff paper we discussed along with the Berkowitz paper addressing some of these questions?

CHAIRMAN KASS:  Yes.  The staff paper will be the second—that was—that will turn into the second chapter where that question will in fact be discussed.

PROF. DRESSER:  So maybe that could be expanded to—

CHAIRMAN KASS:  And that could be expanded as well.  I think, unless somebody has something late to say, I think we understand pretty much what we have to do, and we will do it.  Timetables for next stage is to be worked out after this meeting.  There are too many balls in the air to try to do this on one leg.

If you're willing and not too tired, and I know some people have early departures—we have only one person signed up for public comment, and I think we could probably do this—the next paper in half an hour, 45 minutes tops.

The second of the staff working papers is called the "Application of Human Stem Cells in Research and Medicine."  And I want to put this paper into context as well.

You will recall that we've commissioned five, six, seven—seven research papers.  I think that's right—five on the stem cells of various sorts and varieties, one on the immunological suppression, and I think another one from Dr. Itescu on which topic now escapes me.  So there's seven of those.

This paper is to be understood in the context of those papers, which will appear in the report.

The second thing to say about it is it doesn't attempt to summarize those papers.  It attempts to be an additional contribution, and I think a contribution of real interest.  It needs I think some revised introductory material to help the reader who has just come out of the ethical discussion get into the scientific discussion with a little greater explanatory and narrative clarity.

But what it attempts to do, and I think something quite important, to discuss something which has not generally been discussed in these matters before—namely, the whole problem of getting reproducible results using these preparations and their derivatives and the various kinds of issues that are attached to it, a discussion on pages 2, 3, and 4, with summary toward the bottom of page 4.

Then, a brief review of—with a couple of best studied cases of the exemplary human adult stem cell preparations, and then beginning on page 7, going through page 8, and top of page 9, a brief synopsis of the human embryonic stem cell preparations.  Well, human embryonic stem cell preparations, the cloned embryonic stem cells, and the embryonic germ cells.

And then, just a brief comment on basic research, but then a contribution that I think the public would very much welcome, which is some discussion about how stem cell preparations might, in fact, be used to treat diseases, a question of—what is the situation with respect to the problem of immune rejection, and then a particular case study of considerable importance and human interest—the treatment of Type 1 diabetes.

And current therapy and choices, stem cell therapy for Type 1 diabetes, and then some conclusions about where we are, the conclusions stated on page 13.  And I think what we mostly want here—Dick Roblin is responsible for the work on this.  He has had consultation with Elizabeth, with Bill, with Janet, and we can get additional reviews on the science.

The question here is not the accuracy of the scientific detail, but a more general comment on the chapter, understanding that it will be—there will be some additional material sort of at the beginning to help people get into it.

Jim Wilson.

PROF. WILSON:  I am not gifted at reading these scientific documents, and I read this document twice, and I don't understand a word in it because it is written so exclusively in medical terms, with which I am unfamiliar.

I will give you some examples if you want, but I would be happy to pick them at random.

(Laughter.)

Now, if we're addressing an audience other than physicians, who clearly will understand this, we have to convert a lot of these terms into language that a non-physician audience can understand.  And this requires rewriting the whole thing from beginning to end with lots of explanatory definitions and the use of commonplace words suitably defined that refer to things that are otherwise referred to simply in physician language.

This is a big job, but I think the paper is of sufficiently great value that it's a job worth doing.

CHAIRMAN KASS:  Is Jim's view shared amongst the non-scientific members of the group?  Do people have similar difficulties?  It's not just that he's a social scientist.

PROF. WILSON:  I would not be surprised that I'm the only person at this—

(Laughter.)

—but the country is filled with a lot of people who are like me.

(Laughter.)

CHAIRMAN KASS:  Would that it were true.

(Laughter.)

Bill Hurlbut.

DR. HURLBUT:  I felt the same as I read the document, even though I know the words.  And it did strike me that at the very least we might add a glossary to our—

CHAIRMAN KASS:  There is going to be a glossary.

Elizabeth, please.

PROF. BLACKBURN:  I'm coming at it somewhat differently, with the idea that in the many, many trees that Dick has so competently and thoroughly outlined, we weren't getting a distillation of the forest here.  And whether that is put up front or at the end is very important, because this is just on the foreground.  There might be more about this, because I do have some other suggestions which didn't relate specifically to this issue.  So shall I hold them until others have addressed this particular aspect?

CHAIRMAN KASS:  I think the—to make this general reader-friendly is an exhortation which will be followed.  And it's certainly doable.  I mean, these are complicated things, so you can't simply water everything down.  But I think we can provide help with the terms, a certain kind of clarification of what the issues are before one gets into them.  And I don't think it's that difficult.

Still on this point, before Elizabeth goes somewhere else?  Gil.

PROF. MEILAENDER:  I didn't think it was as bad as Jim suggests.  I mean, there are a lot of sentences in it that I understand perfectly well, in fact.  I mean, I just looked at one here—rats paralyzed by a virus-induced nerve cell loss recovered partial motor function after transplantation with the human cells.  No problem.  You know, that's fine.

(Laughter.)

PROF. SANDEL:  That's only because they showed us a video of those rats who are—

(Laughter.)

PROF. MEILAENDER:  It did remind me of that.  It did remind me of that.

PROF. GEORGE:  There's another intelligible sentence on page 10.

CHAIRMAN KASS:  Come on, guys.  Let's stay on point, please.

PROF. SANDEL:  And at the time you thought those rats were hobbling pretty badly.

(Laughter.)

CHAIRMAN KASS:  They're now trying out for the Lakers.

PROF. MEILAENDER:  The problem is that there are other terms that, again, I'd be happy to see it made more user-friendly, that I'm not sure can be replaced.  I mean, you know, so I just look down—I see lymphocyte.

The problem is that the non-scientific reader has to remember from one sentence to the next what lymphocyte is.  You know, you can tell yourself what it is, but you have to remember it.  But there may be no replacement for it, so, I mean, I just—I don't want us to hold out unrealistic possibilities for what can be done here.  I think that there are a lot of terms there aren't any replacements for.

CHAIRMAN KASS:  Right.  Still on this same point?

Elizabeth, please continue where you would like to go.

PROF. BLACKBURN:  Well, I think that the big issue, if we're trying to inform the public about the situation as it stands now, is that there's a big gap which isn't explicitly addressed.  And that is that nobody has done a side-by-side analysis of human embryonic stem cells and human adult stem cells in a side-by-side way, which isn't encumbered by commercial pressures and isn't encumbered by even, you know, polarized arguments.

And that's something that so clearly I think would belong in, you know, the public funded realm that I think that the public reading this would think that such comparisons have been done.  They haven't.  And those arguments about which is best for what—every time you hear these arguments you know that the person making them is very much, you know, for their own either scientific passion or for the—or for commercial reasons.  We're getting only one side of the story. 

And so I think publicly funding honest side-by-side uncommercially encumbered comparisons for certain things is really sorely missing.  And you can't make—you know, talking about truth-telling, how can they be told the truth when we don't even know what the truth is, and there hasn't been a mechanism to find it out in an unencumbered way.

CHAIRMAN KASS:  We can certainly make that point.  We can make that point very clearly.

Bill May.

DR. MAY:  I understand the desire to make it more accessible to the general reader.  But at the same time, I think, as it bears on the whole of what we do, the scientific community will be wondering whether we are—

CHAIRMAN KASS:  We know our stuff.

DR. MAY: —fully cognizant.

CHAIRMAN KASS:  Right.

DR. MAY:  And so we cannot sacrifice accuracy about that for this question of general readability.

CHAIRMAN KASS:  Absolutely.

PROF. BLACKBURN:  I think distillations and sort of distillations of sections of it, that the reader can—you know, like executive summaries.  You put the main point at the beginning, and then you go into great depth.

CHAIRMAN KASS:  Yes.

PROF. BLACKBURN:  And I think those can be done effectively, you know, without—it's carefully done without too much loss of accuracy.  I agree it's tricky, but I think it could be done.

CHAIRMAN KASS:  We can do it.  We can certainly do it.

General agreement that the aspiration of this chapter, as an addition to the several review essays, what it tries to do—I mean, I think the fact that there's a kind of case study and that one has to—enables people to see what all has to be done before this can be successful I think would be—is a very useful contribution.  And also, the materials about the reliability of getting reproducible results from reliable preparations, and some of those difficulties.

I think there is just a lot of confusion out there about how easy this is going to be and how quickly it's going to be accomplished.  And also, the point that Elizabeth makes about the importance of actually getting the data and finding out the truth about side by side and these sorts of things would also be—

PROF. BLACKBURN:  Which relate to that point of we don't know how—

CHAIRMAN KASS:  Exactly.

PROF. BLACKBURN: —easy these things are, because we keep getting viewpoints about this, which I—

CHAIRMAN KASS:  All right.  Could I—let me indulge myself for one moment to ask Alfonso one question from the last session, and we'll have our public comment. 

On hypothesis, just so that I can go away and think about this, I know you think that dignity is a term referred to human beings, and you give Kant as your source, and we can argue about all of that on some other occasion, but—and that there is, therefore, continuity.

If granting a hypothesis that we regarded an oak tree as having dignity sub five, not human, and that you don't cut down oak trees with impunity save when they're either going to spread disease in the neighborhood or are going to fall down, would the argument then mean that the acorn was, by virtue of continuity, equally dignified?

DR. GÓMEZ-LOBO:   Well, it's a very loaded question, actually, I think. 

CHAIRMAN KASS:  But it has to do with the continuity question, and I don't want to—you know, if you could reject the example as being—

DR. GÓMEZ-LOBO:  No, I love the example, because we've been struggling with it I think.  Well, there are two different things.  There is—one is the question of continuity; namely, whether an acorn is an oak tree. 

Now, it seems to me that I don't know my botany very well here, but—and this argument has been made to us a number of times.  It seems to me that an acorn is not an oak tree if, by oak tree, we mean something like the adult tree.  But surely every oak tree is a successful acorn.  Acorn and oak tree are just stages in one organism, in the same organism, and that's the basis of something like genetic intervention.

If you intervene in the acorn, it's because you want to get an oak of a certain sort.  So that's the continuity argument, it seems to me, really translates into sameness for one specific acorn and one specific oak tree.

Now, the question of the dignity, again, is different.  I think that, of course, we can have something like analogs to dignity.

CHAIRMAN KASS:  I wasn't asserting that an oak tree has dignity, but on hypothesis I—

DR. GÓMEZ-LOBO:  The hypothesis that you treated—let's leave the word "dignity" out.  Let's say you treat the oak tree as having a certain high worth, a certain worth.

CHAIRMAN KASS:  Yes.  But is the argument by analogy that its germ has comparable worth?  That was the only point.  And the answer I suppose is that's a dumb question, or—

DR. GÓMEZ-LOBO:  No, it's a very appropriate question.  But again, I have to modify the hypothesis.

CHAIRMAN KASS:  Okay.

DR. GÓMEZ-LOBO:  Because the reason why we respect an oak tree I think is very different from why we respect a human being.  But, you see, it's linked to the state of the oak tree as an adult, and that's why it doesn't—the analogy is a disanalogy.  Now -

CHAIRMAN KASS:  We'll fight about it.

DR. GÓMEZ-LOBO:  Okay.  Anytime.  Anytime, anyplace.

CHAIRMAN KASS:  It's not accepted as a reasonable example without further discussion.  I'm not surprised.

Let me—

DR. GÓMEZ-LOBO:  Okay.  But you did accept my last point that the reason we have not to cut down an oak tree is intimately linked to its state in which it finds itself?

CHAIRMAN KASS:  No.

DR. GÓMEZ-LOBO:  No.  Okay.  Well, we'll fight about it.

CHAIRMAN KASS:  We'll argue later. 

Look, we have only one person requesting to make public comment—Andrew Sperling from the National Alliance for the Mentally Ill.  And I think we should just go and have the public comment, and then we will adjourn.

Mr. Sperling, the floor is yours.

Oh, excuse me.  You know what the problem is?  We are obliged—the public comment session I think is scheduled to begin at 11:30.  I make it 11:26, 25, and technically I'm not allowed to open the public session before that time.  So—

PROF. GEORGE:  Do you want to do oak trees for four minutes?

(Laughter.)

DR. KRAUTHAMMER:  No.  No, no.  Spare us.

(Laughter.)

PROF. SANDEL:  Well, if it's oak trees, I will tell them to hold the flight.

(Laughter.)

CHAIRMAN KASS:  You're excused.

PROF. SANDEL:  I don't want to miss anything good.

CHAIRMAN KASS:  How can we guarantee that it will be good?

(Laughter.)

Take your chances.

(Laughter.)

DR. KRAUTHAMMER:  Well, about the embryo and the parents—

CHAIRMAN KASS:  Does someone have—could that be Mr. Sperling?

PROF. BLACKBURN:  I have a suggestion.

CHAIRMAN KASS:  Yes.

PROF. BLACKBURN:  The oak tree has had a large journey and a long history, which distinguishes it from the acorn in the same way an adult human has had a long history and a large journey to go through and all of that associated with it in a social context.

DR. GÓMEZ-LOBO:  Sure.  It has a long journey, but don't oak trees come from an acorn?

CHAIRMAN KASS:  That was what I was trying to get you to say.  But, you know, just as many embryos are called, few are chosen.

(Laughter.)

So many acorns, so few oak trees.

DR. GÓMEZ-LOBO:  That's a sophistical argument.

(Laughter.)

CHAIRMAN KASS:  No, no, no.  I mean, that is to say there being a—and since you never know which of these acorns might become the oak tree, just as you never know which of the embryos will in fact survive, you will—you are inclined to accord full respect to every embryo.

DR. GÓMEZ-LOBO:  Sure.  But, you see, the problem—and I argued it in my paper—is that non-viability or the fact that an organism can be destroyed along the way does not affect its nature.

CHAIRMAN KASS:  Okay.

DR. GÓMEZ-LOBO:  I mean, we respect a certain organism because of its nature, not because of the chances.

CHAIRMAN KASS:  Well, then, the question -

DR. GÓMEZ-LOBO:  See, that's the confusion in these discussions.  People confuse potentiality with mere chance of making it viability.

CHAIRMAN KASS:  Very good.  Now, I'm corrected, but then it seems to me you should want to say that whatever the worth of the oak tree, such is also the worth of the acorn.

PROF. GEORGE:  No, you don't have to say that for this reason.  Everything depends on why we accord worth to the object.  In the case of the human being, what Alfonso argues and what I argue is that the human being has dignity in virtue of the kind of entity it is.

With the oak tree, we're not worried about its worth in virtue of the kind of thing it is.  We're interested in its—

CHAIRMAN KASS:  Why not?

PROF. GEORGE:  Well, for the same reason that we distinguish an oak tree, a full adult oak tree, from a sapling.  We're not—we don't care a whole lot about a sapling.  Leave acorns out of it.

CHAIRMAN KASS:  You don't care about the weakest amongst them?

PROF. GEORGE:  We certainly care about children, and we don't distinguish the child, even the infant child, from the mature adult, even if he has the intellectual capacity of Albert Einstein or the skill of a great quarterback, or something like that.

And what that I think reveals is that we're interested in the oak tree by virtue of the beauty of the oak tree, its extraordinary magnificence, not in virtue of the kind of thing it is, because it's the same kind of thing that the sapling is, and the same kind of thing, at least as I understand the botany, that the acorn is.

Contrast that with the human being, if we hold, which I believe we should, which I believe you do, that the dignity of the human being has to do with the kind of thing it is and not its magnificence, not its—not the brilliance of Albert Einstein, not the skill of the adult quarterback, and that the infant at least has it just as much as Albert Einstein does.

CHAIRMAN KASS:  I don't think you could accept—I don't think you can exempt kind from fullness altogether.  But that's a long—

PROF. GEORGE:  Don't we do that in the case of the infant child and Albert Einstein?

CHAIRMAN KASS:  Yes.  But I don't think—well, I have to think about this some more, but I would be disinclined to say that—we have a certain kind of utilitarian view of nature, which leads us to somehow accord it things rather than to say that it has some kind of intrinsic worthiness.

And if you're willing to go that language, then it seems to me—and this is not an intermediate respect or anything that's going to get us, but I'm not sure that young lion cubs and the mature adult are not somehow, by virtue of being the same kind, equally dear.  And that then pushes the argument back to the beginning, and then I move to the plants and—

PROF. MEILAENDER:  You think they're not equally dear, or they are equally dear?

CHAIRMAN KASS:  I think they are.

PROF. SANDEL:  To each other.  However dear they are, they are equally dear to each other.

DR. MCHUGH:  Can a doctor jump in here for just a minute and tell you why I hate this word "dignity."

(Laughter.)

I hate it.  I've seen the use of the word "dignity" being used to do all kinds of crimes.  We're going to live with dignity or die with dignity, or whatever with dignity, and I'm finished with that word because I've seen it in killer's hands.

What I want to acknowledge is the endowed nature of the kind that is human beings.  I want to go back to our founding document.  We are endowed by our creator with certain inalienable things, and these things include the right to life.  And that right to life begins, in my opinion, with the zygote, not with the clonote.

(Laughter.)

CHAIRMAN KASS:  We've had our commercial break.  We've made it exactly to 11:30 and the beginning of the public session.  And I have a suspicion that our little song-and-dance routine has produced Mr. Sperling.  If he is here, the microphone is yours, sir.

Take a moment.  I don't mean to rush you.  But we finished a few minutes early, and by law we have to wait until 11:30.  And I'm glad to have you here.  Welcome to the Council.

PUBLIC COMMENT

MR. SPERLING:  I apologize.  I've got some notes I made last night, but before—good morning, members of the Council and Dr. Kass.  Thank you for allowing me the opportunity to speak.

My name is Andrew Sperling.  I'm the Director of Federal Legislative Advocacy for NAMI, the National Alliance for the Mentally Ill.  NAMI is a national organization representing 210,000 members, 1,200 affiliates.  We are the largest national organization representing people with severe mental illnesses and their families, including illnesses such as schizophrenia, bipolar disorder, manic depression, severe anxiety disorders.

At the outset, NAMI wants to recognize and respect the spirit in which "Beyond Therapy" has been brought forward and approved by this Council.  We think it's an enormously important work that was certain to provoke a great deal of debate across our country.  We believe it's important to foster public attention and debate on these profound issues related to the ethical implications of biotechnology and its advance in society.

We respect that this is not a policy document.  It is not about legislative or policy recommendations.  And its intent is to provoke a national debate about some very profound and very difficult and complex issues.

We also recognize, NAMI recognizes, that this report has made important distinctions between appropriate use of medical technology for medical treatment on the one hand and employment of the same technology for personal improvement and enhanced performance on the other.  It's an important distinction, and we want to recognize that the Commission—the Council made that distinction in its report.

More importantly, NAMI recognizes that the ethical and long-term societal implications of this distinction are worthy of a serious, sober examination and informed debate—a debate that can and should be furthered by this report.  NAMI in no way questions the high motives behind this report and the serious intent under which the Council has undertaken this responsibility.

In short, NAMI recognizes that what—this report is long overdue in provoking an important debate about the long-term implications of biotechnology.  And we do not in any way question the motives of why this report has been brought forward.

At yesterday's meeting Dr. McHugh laid out for you an historical legacy of the stigma and discrimination associated with mental illness—a stigma and discrimination that still exists to this day.  Despite the enormous progress that we have made in advancing research and treatment on mental illness, that there still exists unfortunately a prevailing view in society that these illnesses may not be real, may be illusory, and that if people could just pull themselves up by their bootstraps, they could overcome mental illness.  And this is a view that Dr. McHugh really rebutted very effectively at your meeting yesterday.

We want to recognize that there is, you know—many of the dangerous forms of this stigma are still put forward by well-organized and well-funded interests in America today, and they do it under a cloak of human rights.  Okay?  They are both—in some cases ex-patient—what they call survivor organizations, people who have received treatment from the system.  They believe they never had a mental illness and believe that the treatment really—treatment is a form of oppression or a violation of their human rights.

And we also have groups such as the Church of Scientology that publicly call into question whether mental illness even exists. 

And the concern that NAMI has with the report is not the content—we want to be clear.  The concern is that the unintended uses that—there are interests out there that don't have the same motivation, essentially laudable motivation that this Council had in bringing this forward.  And the concern that NAMI has is that this report might be used by those interests to further what NAMI views as a very dangerous agenda to calling into the question the existence of mental illness.

This continues to this day.  Just this past year, the House Governmental Affairs Committee actually convened a hearing where there were witnesses representing the Church of Scientology that called into question the existence of all psychiatric illnesses, but in particular ADHD.

And we—NAMI is concerned that this report might be essentially misused, rather than what its intent is, which is to provoke debate across society—would actually be used to further what NAMI believes is, in some sense, an illegitimate debate and that we believe that medical science has proven beyond a doubt that severe mental illnesses are real, that the treatments are effective, and that there's no justification for enactment of policies that would even call that into question.

So I appreciate the opportunity to offer this public comment.  I want to thank you for your hard work on this.  And NAMI wants to work with the Council to make sure that the findings in this report, the important debate that needs to be provoked, is not—that this report isn't used under the guise of a council that was appointed by the President of the United States to further an agenda which NAMI believes is potentially destructive to people living with these illnesses and their families.

Thank you very much.

CHAIRMAN KASS:  Mr. Sperling, thank you very much.  It's not my custom to respond to public comment, but let put on the record that not just Dr. McHugh, but every member of this Council, agrees with the comments made by Dr. McHugh. 

And let the record show that we have not only no intention of giving aid and comfort to those forces, but we stand ready to join with you in opposition to them.

MR. SPERLING:  Thank you very much, Dr. Kass.

CHAIRMAN KASS:  Thank you.

This question about the November meeting, and what will be done at that meeting, and whether it will be held, we simply have to sit down in the office on Monday and sort out where we are.  Lots has gone on at this meeting.  It's been a terrific meeting, if I may say so.  There were lots of difficult things here, but I think we made very, very good progress on all of our projects. 

I thank you for your very careful and spirited—careful thoughts and spirited conversation.  Have a safe trip home, and we'll be in touch very shortly about the future.

Thank you.  The meeting is adjourned.

      (Whereupon, at 11:38 a.m., the proceedings in the foregoing matter were adjourned.)

 


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