FRIDAY, October 17, 2003

Session 5: Biotechnology and Public Policy: Proposed Interim Recommendations, V


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.)