Altenative sources of pluripotent stem cells: teleconference transcript

Participants present:

Leon Kass, MD, chairman of the President's Council on Bioethics

Amy Balszyk, National Public Radio
Jeannie Baumann, Bureau of National Affairs
Maggie Fox, Reuters
Heather Gagmon, ISSCR
Susan Goldstein, PBS Religion and Ethics
Murray Jacobson, News Hour with Jim Lehrer
Claudia Kalb, Newsweek
Molly Laas, Blue Sheet/Washington Fax
Nancy O'Brien, Catholic News Service
Joe Palca, National Public Library
Susan Poland, Georgetown, Kennedy Institute of Ethics, Bioethics Library
Valerie Schmalz, National Catholic Register
Nicholas Wade, New York Times
Laurie Zoloth, Bioethics, Northwestern University

May 12, 2005
11:45 a.m. CDT

Coordinator: Good afternoon, and thank you for standing by. At this time we will begin the conference with a role call. Do I have Heather Gagnon of ISSCR?

H. Gagnon: Yes.

Coordinator: Thank you. Susan Goldstein, PBS Religion and Ethics?

S. Goldstein: Yes.

Coordinator: Thank you. Valerie Schmalz, National Catholic Register?

V. Schmalz: Yes.

Coordinator: Thank you. Molly Lass?

M. Lass: Yes.

Coordinator: Thank you. Susan Poland of Georgetown?

S. Poland: Yes.

Coordinator: Thank you. Amy Balszyk of National Publications.

Male voice: I think that’s National Public Radio, and I think she’s here.

Coordinator: Thank you. Jeannie Baumann of BNA?

J. Bowman: Yes.

Coordinator: Thank you. Nicholas Wade, New York Times?

N. Wade: Yes.

Coordinator: Thank you. Nancy O’Brien, Catholic News Service?

N. O’Brien: Yes.

Coordinator: Thank you. Claudia Kalb of Newsweek?

C. Kalb: Yes.

Coordinator: Thank you. Joel Palca, National Public Radio?

J. Palca: Yes.

Coordinator: Thank you. And once again, I do have Dr. Leon Kass joining the conference. I would like to inform all participants that today’s call is being recorded. If anyone has any objections, you may disconnect at this time. At this time all lines will be on “listen-only” until the question-and-answer session of the conference. I would now like to turn the call over to your conference host this afternoon, Dr. Leon Kass. Sir, you may begin.

L. Kass: Thank you very much, and thanks to all of you on this conference call. Welcome to this conversation in connection with the release of the President’s Council on Bioethics’ White Paper, “Alternative Sources of Human Pluripotent Stem Cells,” that was transmitted to the President on May 10th.

I thank you for your interest in the Council’s work. I trust that you will have seen the advance copy of the White Paper itself as well as the press release that we sent out. If anybody is interested, as of 1:00 this afternoon, a PDF and an HTML version of the report are now on our Web site, www.bioethics.gov.

In these opening remarks I want to do three things. I want to say why we are publishing this White Paper. I want briefly to give you an overview of its contents, and finish, third, with our provisional conclusions and a couple of remarks again about the significance of this report at this particular time.

First, as to the why of this White Paper: As I’m sure all of you know, human embryonic stem cells hold great interest and present research opportunities of great moment and promise, primarily because of their pluripotency—their capacity to give rise to the various specialized cells of the body—and because of their self-renewing longevity, their ability to be propagated in this form for many generations in laboratory culture without losing this pluripotency.

As you all also know, until now these cells have been obtainable only from living human embryos at the blastocyst stage of development by a process that necessarily destroys the embryos, and that therefore makes this research ethically controversial. And again, no one needs to be told about the ethical controversy over stem cell research. Embryonic stem cell research has been the subject of federal and state legislation and public policy and of ongoing public debate that continues to the present day.

The President’s Council on Bioethics is constituted in a commitment to the twin goals of advancing biomedical science and, at the same time, upholding ethical norms. Council members have sharp disagreements, ethical differences, especially on the moral status of the human embryo, but all of us collectively have recognized that all parties to this debate have something vital to defend and not only for themselves but for all of us.

This is a very important point; it is the point of departure of this report. In our first report, Human Cloning and Human Dignity, we had a split recommendation on the ethics of doing cloning-for-biomedical-research, but all of us agreed with the following statement: “All parties to the debate have concerns vital to defend, vital not only to themselves but to all of us. No human being and no society can afford to be callous to the needs of suffering humanity, or cavalier about the treatment of nascent human life, or indifferent to the social effects of adopting one course of action rather than another.”

Further, as members of a national bioethics body we are mindful of the need to understand and respect the strongly held ethical views of our fellow citizens even when we do not share them.

For these reasons we have chosen always to be receptive to any creative, scientific or technical suggestions that might find a way around this ethical dilemma and the ethical impasse that we now face, and that might enable scientists to proceed with their research but in ways that would neither raise ethical questions nor violate the ethical principles of many Americans.

It has been with this in mind that we have taken a particular interest in specific proposals, now being advanced in several quarters, that would enable scientists to obtain pluripotent, genetically stable, and long-lived human stem cells by methods that would meet the moral standard of not destroying or endangering human embryos in the process.

If such methods could be found, promising scientific research with pluripotent [embryonic-like] stem cells could proceed, funded by the federal government, without ethical qualms or controversy. It’s our submission that all morally serious and public-spirited people should welcome such a resolution to the current vexing dilemma, a solution that avoids the ethical difficulty and our sometimes bitter national and political divisions. This report is conceived in that morally serious and public-spirited attitude, and it is written in order to advance it in the current polarized climate.

Before moving into the content of the report itself, I want to stress one conceptual point. Embryonic stem cells are, to repeat, attractive for two reasons. First, their pluripotency, their capacity to turn into any of the specialized cells of the body, and second, their stable and long-lived capacity for self- renewal in tissue culture without losing that pluripotency.

But if one could get cells that are functionally equivalent to the pluripotent cells that are now derived from living embryos, it should not matter to scientists what their source has been. The goal is not embryonic stem cells because they are cells that come from embryos, but stem cells of whatever origin that nonetheless have the full capacities both of pluripotency and self-renewal that embryonic stem cells have. It is with a view to finding the functional equivalent of the embryonic stem cells now available that we have embarked upon the consideration of these proposals.

Second, let’s talk about the proposals themselves. The bulk of the report reviews four distinct possible methods for obtaining such pluripotent human stem cells. First, they could be derived by extracting cells from embryos that have already died. Not just the ones [embryos] that are doomed to die because no one wants them, but embryos that one can pronounce dead because they are no longer doing what the organism at that stage does. I’ll return to that.

Second alternative: [cells might be obtained] by non-harmful biopsy of living embryos, analogous to the procedure now used to do preimplantation genetic diagnosis, looking for genetic disorders, in in vitro fertilization clinics.

A third proposal, one that has already received a fair amount of attention in the press, [cells might be obtained] by extracting cells from artificially created nonembryonic—but embryo-like—cellular systems that have been engineered to lack certain essential elements of embryogenesis but still have some cell division and growth. And the hope is that this biological artifact, which would lack the ontological and moral status of the human embryo, might still be a source of pluripotent stem cells. The White Paper considers a specific proposal, “Altered Nuclear Transfer,” as the means for attempting this particular method.

Finally, the attempt to get pluripotent human stem cells by dedifferentiation: by reprogramming specialized somatic cells back to the pluripotency of their beginnings. To take cells like skin cells or liver cells and by proper stimuli or growth in proper circumstances or by fusion with other cells of a different sort, to get them to go in reverse and return themselves to the pluripotent condition.

I should point out that both proposal three and proposal four offer the opportunity of getting individualized and personalized stem cells identical to the source of the nucleus, genetically identical to the source of the somatic cell. So these two proposals would give you pluripotent stem cells of known genetic identity and presumably potentially useful, ultimately, should therapies emerge from this, of being restored to the original donor without the danger of immune rejection.

Now the report conducts what can only be, at this stage, a preliminary hearing of these proposals, an analysis of their respective strengths and weaknesses, ethical, scientific, and practical, with special attention to the ethical analysis. We give the ethical analysis special because that is our primary concern, but also because the scientific and practical merits of these proposals are in large part empirical matters, and they cannot be settled in advance by mere speculation.

We don’t know which of these proposals might succeed. But we are trying to see whether they would pass ethical muster and to give some special encouragement for people in those cases where we think the proposals do meet the ethical threshold, cross the ethical threshold, to see if people would be energetic in their pursuit of testing the scientific validity and practical utility of these proposals.

Now, if you’ve seen the document, I don’t have to go through the analysis in detail, but let me just be clear that you understand what each of these proposals entails. The first proposal derives cells from embryos already dead. The ethical argument sees this as ethically analogous to the use of organs and tissues obtained postmortem, after the death of the donor. The early human embryo is an organic whole whose cells divide in concert. And when all coordinated cell division ceases, the embryo is dead as an organism. But some of its individual cells may still be viable, and, if extracted and cultured, they may be coaxed to develop into stem cells.

This has not yet been tried, not even in animals, though I understand that the proponents of this approach are in the process of beginning to gear up to do some of the research.

The second proposal takes advantage of the fact that we now do biopsy of living in vitro fertilized embryos, as I indicated before, to do preimplantation genetic diagnosis. One or two blastomeres are removed from a roughly eight-cell embryo prior to its transfer to initiate a pregnancy. Live born children numbering in the several thousands have been born [after undergoing this procedure when embryos].

One doesn’t know fully the risks of this procedure, but it’s at least conceivable that one could biopsy living IVF embryos in those cases prior to transfer in an attempt to produce a child. If this were not harmful to the resulting child, those isolated blastomeres might be coaxed to develop into stem cells.

The third proposal, more complicated to explain, is to try to construct a biological artifact, a certain cellular system that would be “embryoid” or embryo-like, but that would not be an embryo because, from the start, it would have been engineered in such a way that it could not proceed through embryogenesis. It would be more analogous to some of the teratomas that form from gametes and reproductive tissue.

The one proposal that we have for doing this would be to use nuclear transfer or cloning-for-biomedical-research technology, but to modify the nucleus before it’s introduced into the enucleated egg in such a way that that genetic alteration in the nucleus would render the product not an embryo proper but cells that will divide only so far, so that it would lack from the start the ability to form a human embryo. Hence the removal of cells to produce stem cells from such an entity would not be a destruction of an embryo, it not being an embryo in the first place.

Finally, there are a series of possibilities of taking somatic cells—and (1) by culturing them under conditions normally used to culture embryonic stem cells, or (2) by fusing them with other cells, or (3) by extracting factors from oocytes that seem to be able to convert somatic cell nuclei in cloning procedures—and reprogramming them to a more undifferentiated state. The objective here would be to get ordinary body cells to revert to the primordial state of pluripotency.

Those are the proposals. I won’t review the ethical arguments. They are indexed in the Table of Contents. I will just give you then in closing, a review of our conclusions. The Council has no unanimous recommendations to make, not primarily because we are in disagreement, although some of us have preferences amongst these alternatives.

We think it is premature to recommend one or another of these proposals because so much needs to be done scientifically and because there are still ethical considerations to be argued about, in part based upon what the empirical studies would show.

However, in conclusion on the limited threshold question, “Does this proposal appear to meet a minimum ethical standard to justify serious consideration and further scientific exploration?”, we did reach the following provisional conclusions: The first proposal to derive stem cells from organismically dead embryos, although it raised some serious ethical questions, we found this proposal to be ethically acceptable for basic investigation, even in humans, provided that the stringent guidelines mentioned in the document are observed.

The second proposal, blastomere extraction from living embryos, we found unacceptable ethically in humans because we do not believe that one should impose risks on living embryos destined to become children for the sake of getting stem cells for research. One might try this in animals, but it’s not clear to us how the results from animal experimentation could alter this assessment of the ethical impropriety of doing this in humans.

A third proposal, cells from specially engineered biological artifacts, produced the most controversy within the group. A few of us are not eager to endorse even animal or other laboratory work investigating the potential human applications. But most of us believe that this proposal offers enough promise to justify animal experimentation at this time, both to offer proof of feasibility and utility and to get evidence bearing on some of the ethical issues, most importantly on whether this is or is not an embryo that’s defective or whether it is just an embryo-like but non-embryonic body. Since the proposal by the proponents is simply to do the animal work first, the large majority of us are in favor of seeing that tried.

Finally, the fourth proposal of cells obtained by somatic cell dedifferentiation, we find this proposal to be entirely unproblematic ethically and acceptable for use in humans, and would like to see the efforts, already begun along these lines, continued.

We are presenting these proposals at this time, precisely because we think that we ought to be trying to find a way around our ethical impasse. And while these four proposals that are before us now seem most worthy of analysis at this time, we think it’s possible, indeed likely, that other avenues to human pluripotent stem cells not requiring the destruction of human embryos may be proposed or discovered in the future.

We are not intending to exclude any of these additional alternatives. On the contrary, part of the reason for publishing this now is to encourage scientists creatively to devise other and better proposals and to highlight the appeal of this large and morally responsible purpose to find ways to advance pluripotent stem cell research that all of our fellow citizens can wholeheartedly support.

This end is, in the view of the Council, a desirable goal for our society and one that justifies, we think, making the extra effort to seek out, to assess, and to attempt new, ethically uncontroversial methods of stem cell derivation. This, by the way, would set a very nice precedent for similar kinds of ethical controversies that we know are coming.

It’s much better to see if we can use our ingenuity to find some way in which we don’t have to either have a permanent stand-off, each side morally at war with the other, or a forced political solution that will alienate a large segment of our population as the price of victory for one side. This is a wonderful way forward if it can be scientifically demonstrated. I think that people of good will and public spirit ought to be very interested in this prospect.

With that somewhat more long-winded summary than I’d intended, let me just open the conversation to your questions. I thank you again for your interest.

Coordinator Thank you. At this time, we’re ready to begin the question and answer session. Our first question comes from Nicholas Wade. You may ask your question.

N. Wade: Hi, Dr. Kass.

L. Kass: Hello, Mr. Wade. Nice to hear your voice.

N. Wade: Nice to hear yours, as always. I have a two-part question. One is that in the long history of presidential bioethical commissions, this seems to be the first one that I can recall where there has been a split between the ethicists and the scientists who usually find there’s a lot of common ground. But in this case, the two members of your committee, who I would characterize as being hands-on research scientists, Michael Gazzaniga and Janet Rowley, have worded quite sharp dissents. Gazzaniga saying all these are “high-risk gambles” and Rowley is saying that one of the, the first proposal, is the height of folly.

If you can’t keep the research scientists on board, why should the scientific community listen to you, if you haven’t persuaded even your own members who are scientists? So, could you comment first of all on this split which has occurred not only in this report but also, as you mentioned in the previous one on therapeutic cloning, and second, isn’t the range of your authority or moral suasion sharply limited by the fact you’ve not managed to keep these research scientists on board?

L. Kass: Well, the two research scientists differ slightly. By the way, there are three other physicians. One of them is in fact a research scientist as well, Dr. Foster, who has endorsed this report as written. Dr. Paul McHugh at Johns Hopkins, and Dr. Ben Carson are physicians and they have endorsed this report.

Dr. Gazzaniga, [and they can speak for themselves], he simply wants us to go ahead with the research without seeking a way around this moral dilemma, partly because he doesn’t personally feel this moral dilemma himself. And he is in print on this. He doesn’t see what the fuss is about, about the embryo. Therefore he doesn’t seem to have an interest in trying to find a solution since he, I think, believes that the opposition to this research is, as he will put it, based upon “the arbitrary views” of people “with certain beliefs about the nature of life and its origins.”
I think he is the only person on the Council who has that view that treats the human embryo, until its got a brain, as the moral equivalent of lumber in Home Depot. In your newspaper, I think the other day, he [was quoted] as saying as much.

Dr. Rowley is, I think, she in fact reserves some judgment for the fourth proposal that doesn’t involve embryos, that this proposal should be submitted to the NIH and if it passes peer review with sufficiently high score to be funded, research would go forward. Her major concern about this is that to do this research you will be draining financial resources from the already under-funded research in this area.

But I would point out that at the present time there is a limitation on federal funding of this research, Congressionally mandated, as a matter of fact, and some scientists are interested in developing new [stem cell] lines. And since they are interested in developing new lines with genetic heterogeneity and even with determined genomes, it seems to me that people who would be interested in increasing federal funding for this kind of research might in fact have a positive interest in at least having some resources, possibly even federal funding, available to try to develop these new lines [by these alternative methods—since they might then be eligible for federal funding].

There have been certain a priori objections to some of these proposals from scientists. But I’m sort of astonished. I’ve always thought that scientists were loath to rely on a priori speculations, that they really ought to be interested in getting the evidence.

There are some scientists, and I could give you some names if you would like, of people who have expressed an interest in this and who are even themselves investigating some of these possibilities, most especially the reprogramming and the dedifferentiation track, proposal four.

Even since this report went to press, there have been articles published and reports made at meetings which suggest [great promise in this area]. There is an unpublished report in which mature mouse cells have apparently been reverted to pluripotency, through experiments that fuse them with mouse embryonic stem cells in which the resulting cells are genetically identical to the somatic cell. Somehow the nucleus of the embryonic stem cell has managed to contribute to the reprogramming [of the somatic cell].

There are serious scientists at work on this. And this is, in a way, an invitation to the scientists who I think, by the way, also have a stake in not simply permanently alienating this large segment of the population. If there is a way to go forward for the scientists to proceed with the political and moral blessings of the community as a whole, how much the better wouldn’t that be for science?

N. Wade: If you’d allow me, a follow-on question. To repeat the previous question, as the outsider looking in, there are two committees that have now, within the last few weeks, opined on this issue. The one from the National Academy of Scientists has ethicists and scientists who came together and agreed in the usual way. So that is an agreed consensus position between ethicists and scientists of the type we’ve been used to seeing from presidential bioethics committees.

But your committee has, as I said, come out with a largely split or substantially split decision. So which group of ethicists should the man in the street prefer, the ones who seem to have found common ground with the scientists or the one who seem to be off by themselves in a different place? My basic point is, surely your conclusions would be more persuasive if you had kept your scientists on board, which you have not.

L. Kass: I repeat, we’ve kept some of them on board, if you read those dissents carefully. In the second case [Dr. Rowley’s], it is not an objection to the effort except if it’s a drain on resources, although one of the proposals comes in for rather harsh remarks from Dr. Rowley. But look, if you get yourself the right kind of bioethicists who share the basic world view and moral sensibilities of the scientists, of course you’re going to find consensus.

This is the first national bioethics council that is, in fact, ethically heterogeneous. The previous ones may have had one token pro-life member. We’ve got half a dozen. That is much more representative of the nation as a whole. [But if a scientific academy] gets our [scientific] experts and your [ethical] experts together [but] who [all] basically share the same metaphysical world view, who don’t regard nascent human life as anything to be worried very much about, [then you have a less diverse committee, one that’s much more likely to reach consensus because they already agree on the core issues]

Without meaning to criticize the report of the National Academy of Sciences, one should simply recognize that they have accepted the basic question as settled, that it’s not only not problematic to use the spare embryos, but it’s morally acceptable [even] to create embryos solely for research, both by cloning and by in vitro fertilization. If you’ve jumped past that hurdle, you’ve in a way begged the major question about which the country really is divided. And of course you can get a [favorable] hearing amongst those people who share those views.

But we are much closer in our diversity and heterogeneity to the facts [regarding] the county as a whole, and this particular document is an attempt to try to speak to the country as whole, [looking for an alternative] that does not force a political solution that will alienate the losing side, or worse, that allows this controversy to fester because there are people on both sides who don’t want to compromise and who would just as soon rub the other side’s nose in defeat.

So I think, quite frankly, what we have here is an extremely ethically diverse group and sure, we could solve our problems by appointing ethicists who in every fundamental respect don’t really differ from the scientific community whose work they’re supposed to scrutinize and to some degree restrain.

N. Wade: Okay, thank you.

Coordinator: Dr. Kass, at this time we show no questions.

L. Kass: Is this it?

Coordinator: Actually, Nicholas Wade, of New York Times has just queued up. Sir, you may ask your question.

N. Wade: I’ll actually ask another question if no one else is doing so right now.

L. Kass: I like talking to you, Mr. Wade.

N. Wade: Thank you. This is a somewhat technical question but I noticed that in discussing the Dickey Amendment, you point out that the use of federal funds for research and cells derived by someone else’s prior destruction of a living embryo violates the spirit of the Dickey Amendment. Did not part of Bush’s August 9 policy also violate the spirit of the Dickey Amendment in that precise sense?

L. Kass: Well there are people who think so, Mr. Wade, and there is controversy about it. But this is not the first thing the Council has done on stem cells, as you know. We published a report in January of 2004, if my dates aren’t wrong, Monitoring Stem Cell Research, in which there is a long discussion indeed of the underlying moral and legal principles of that decision.

That decision was really to allow, for the first time, federal funds to be used precisely because the destructive act had already taken place, but to do so in such a way that it did not provide incentives or reward future destruction of embryos of the sort that Congress has expressed itself being interested to forefend. The President, in so doing, reaffirmed the principles that life may not be exploited for the benefit of others.

It’s a tough call but if you’re asking me for my personal opinion, I do not think that the President’s current policy violates either the spirit or the letter of doing so. I think what would violate the spirit, if not the letter, would be proposals that say, “Let people in the private sector destroy the embryos and produce the stem cells and then the government can fund [research on] them with a clean conscience.” It might fit with the letter of the law, but it surely doesn’t fit with the spirit of it.

N. Wade: Okay, thank you.

L. Kass: Could I say one more thing to you, Mr. Wade?

N. Wade: Sure.

L. Kass: There are several personal statements at the end of the document. I meant to call attention to them. But what’s striking to me here is that while the press is interested in the controversy, I think what’s really quite striking is that there has been an effort here responding to some efforts being made in the scientific community, from scientists not necessarily represented on the Council, that science really can contribute a way around this ethical difficulty.

It does not merely have to be partisan on one side. I think the message of this report is, “Here is an invitation. Here is the showing of a way forward.” And I don’t see why one should, in this particular scientific matter, stand on the sidelines and say, “This won’t work,” when it has yet to be tested and could be tested relatively economically.

I would underscore the absolute ease of proposal number one in which you do natural history studies of embryos that have reached cleavage arrest, and see if cells taken from those dead embryos can in fact be turned into stem cells. I would also emphasize the great excitement—I’m sure that you will be reading about it in the months to come—about efforts to dedifferentiate [or reprogram] somatic cells [back to pluripotency] so that you’ll never have to go through an embryo and you would get pluripotent stem cells which are personalized and of known genetic origin. Wouldn’t that be terrific?

N. Wade: Okay, thank you.

Coordinator: Our next question does come from Joel Palca, of National Public Radio. You may ask your question.

J. Palca: Hi, Dr. Kass. Following on to the comments you’ve just made, I wonder if you’ve had any discussion either with the White House or the Department of Health and Human Services or the National Institutes of Health, to encourage them possibly, to be more proactive? Instead of perhaps waiting for the scientific community to respond to this broad appeal, to have the Administration say, “We’re actually putting our money on the table and if you want to make a proposal that would embrace one of these avenues, we’ll make some money available to you.” I know that is not your job, of course, but I wondered if you’d gone to the White House and said, “Here, we’ve got these ideas, but we need your support.”

L. Kass: Thank you for the question. The White House has . . . Because these conversations in the Council have received much publicity in the press going back to our December meeting of last year, the White House is of course aware of these discussions and I know that they were quite interested in this White Paper.

One of the reasons, I think, why we produced a White Paper rather than wait and wait and wait until more data is accumulated, is precisely that we would like to send a signal of encouragement and hope that the White House will pick up on this. They have to digest the ethical analysis and try to decide which of these things might in fact be eligible for federal funding.

We discuss arguments about the eligibility for funding. But whether it’s prudent to invest your money in these proposals depends in part on what else the budget has to support. That is a call that our Council cannot make. We’ve sent advance copies of this [White Paper] to Dr. Zerhouni, to Secretary Leavitt. And I imagine that there will be conversations in those places in the immediate future.

I would like to see some kind of encouragement. Speaking not as the chairman of the Council but speaking for myself personally, I would like to see some encouragement of requests for applications. That doesn’t commit anybody to funding them. They have to pass scientific muster. But if clever people are out there showing how you can dedifferentiate somatic cells to get pluripotent stem cells without going through embryos, let them come forward. And if those proposals measure up, I for one would certainly like to see this Administration encourage their funding.

J. Palca: Okay, thank you.

Coordinator: Our next question comes from Maggie Fox of Reuters. You may ask you question.

M. Fox: Well, Dr. Kass, right on that subject, I know from the very beginning when I’ve talked to some people like Dr. Gearhart, they say that’s exactly what they want to study embryonic stem cells for. They don’t want to have to continue using embryos because if nothing else, ethical considerations aside, it’s cumbersome. This is exactly what they need to study the embryonic study stem cells for is to find out what the mechanisms are so that they can activate those mechanisms (in the)… cell.

L. Kass: Right. First, let’s all be clear. A fair amount of demagoguery has produced a widespread belief that there is a federal ban on embryonic stem cell research. There is no such ban. On the contrary, there is in fact federal funding for human embryonic stem cell research, without limit as to the amount, the only restriction being that the [embryonic stem cell] lines which are eligible for funded research have to have been derived, and therefore the embryo- destroying deed having had to take place, prior to the President’s making of his decision. The rationale for that, we don’t have to go into now, but it’s in the Council’s Monitoring Stem Cell Research report.

To take a specific example, it would be possible, at least in principle (and it is being discussed now), that you could use some of the stem cell lines that are eligible for federal funding . . . —[of the eligible lines] numbering somewhere in the low 70s, some 22 or 23 are now actually available, characterized and out there in use—one could use those embryonic stem cell lines, eligible for federal funding, and try to see if fusing somatic cells with those embryonic stem cells would lead to the dedifferentiation of human somatic cells to produce pluripotent cell lines with known genetic makeup. [A specific experiment of somatic cell reprogramming.]

There is nothing in the present law, or it seems to me, in the present funding restrictions, that would preclude that kind of research. Congress is still on record as saying, “Federal funds may not be used in research in which human embryos are harmed or destroyed.” That’s still the law. The question is, within the constraints of that law, the President has found ways to support that research and that research goes forward.

There are scientists who feel it’s not going forward rapidly enough. There are scientists who believe that we must have, right now, new cell lines. And there are solid arguments that they make. But the policy is a moral policy and the question is whether within the moral principles and guidelines for that policy we can use the available embryonic stem cell lines eligible for federal funding and use them and use all of these other new possibilities to find a way to do this research, as Dr. Gearhart, I know wants, without ever having to go through the embryos again. Was that clear, Ms. Fox?

M. Fox: It’s clear.

Coordinator: Dr. Kass, at this time we show no further questions.

L. Kass: All right, let’s give the reticent students a moment or two. If anybody wants to ask a question, now is the time. If not, let me thank you for your interest in the Council and its work.

Coordinator: Dr. Kass, Nicholas Wade of New York Times has queued up.

N. Wade: I’m not usually this greedy about filling out question time but since there was a pause, can I ask a third question? With respect to your response about the bioethicists who are working with the National Academy of Sciences and with previous presidential bioethics committees, were you not implying, Dr. Kass, that they had in a sense sold out to the scientists?

L. Kass: No, I don’t want to say that at all. These are serious people who call the ethical questions as they see them. It has rather to do with the composition of these bodies. And some of the panels that were convened to discuss the ethics of embryo research at NIH were in fact explicitly designed to exclude anybody who had any grave doubts about doing embryo research at all. If you exclude those people, a fair number of the problems and the ethical disagreements go away.

N. Wade: Right.

L. Kass: I give you an anecdote. Prior to the panel meeting, the workshop that the National Academy of Sciences convened last October that was in the early stages of producing the report that they’ve just issued, there was a dinner the night before I made my presentation. And a Harvard Medical School scientist whom I did not know, whose name I knew, sat at the table with me and he said to me, “I know how to solve the problem of your Council.” I said, “Really? I would like all suggestions.” He said, “Appoint some bioethicists.” I said, “But we do have bioethicists.”

I listed the number of people who, in fact, write in bioethics. By the way, there are people who are entirely on board with this document who are in fact opposed to the President’s policy on stem cell research. They would like to see something more liberal. But they would even more prefer to see something that didn’t require one side or the other to simply have to give way.

I pointed out to him that we have people who’ve been in bioethics for 30 years and other people who, though they haven’t worked on this area, are quick studies and wise souls, many of whom, by the way, agree with him on this question [i.e., of embryonic stem cell research]. He said, “Well, you don’t have the kind of bioethicists we have at Harvard.” And it took me a half an hour to point out to him that the problem wasn’t that we were stubborn or that I was saddled with a bunch of superstitious Neanderthals.

It took a long time to persuade him that there were real issues here, that there was a real difference of opinion on the propriety of creating human life solely to experiment on it. There are lots of Americans, even those who want the benefits of stem cell research, who have grave doubts about the morality—and if not about the morality, then about the wisdom—of starting down this road of instrumentalizing nascent human life, no matter how good the result.

If you don’t see that that’s a moral problem, you could have a Ph.D. in ethics, but you’re going to block out the moral sensibilities of lots of people, nonreligious as well as religious.

So I want to praise the ethicists who’ve served on previous bioethics councils. They’ve done their job. They’ve done some good work, but they’ve been so constituted that either the large questions were sort of punted or there was such unanimity about the large questions that you didn’t even know that were any large questions still hanging in the public at large.

One of the things I’m most proud of this Council for is that we were, by design, created in some way to reflect the deeper divisions that are in the American society, and without papering over those differences, we have found ways to try to move the discussion forward and to, in a way, legitimate those disagreements rather than make them go away.

N. Wade: Okay, thank you.

Coordinator: Our next question comes from Claudia Kalb of Newsweek. You may ask your question.

C. Kalb: Dr. Kass, hi.

L. Kass: Hi.

C. Kalb I had a question that sort of relates to the first proposal in this report, which is the question of the embryos that are at the IVF lab and being thrown away, which a lot of people point to as an issue. Why is that a moral problem and how different are those embryos from the first proposal here being the dead embryos?

L. Kass: Right. Look, this is of course a very difficult and complex moral discussion. There are roughly 400,000, by recent survey, human embryos stored in the freezers. Most of them are no longer wanted for the reproductive purpose for which they were first created. An argument is, if many of them are going to die anyhow, or be discarded, why should not their demise be redeemed by making them useful for the benefit of other people? That is, one has to say, a certain powerful moral argument.

However, being doomed to die is not yet being dead. We do not ethically allow the removal of kidneys and livers from people on death row or from people who have three or four weeks left to live. We have insisted morally that simply being in the fatal condition or terminally ill does not yet put one beyond the boundary where ethical removal—with consent—is somehow appropriate.

Drs. Landry and Zucker of Columbia University Medical Center, who are the authors of that proposal, one of the reasons why they wanted to restrict this to the embryos that were in fact already dead is that they would in no way be hastening the death of embryos nor would they somehow be involved in it. They would rather treat [only] the embryonic equivalent of a cadaver.

There’s some scientific evidence that living and viable cells can be extracted from embryos that have stopped to divide as a whole and that this would seem to be morally absolutely uncontroversial; whereas destroying an embryo that was not yet dead, simply because someone no longer was interested in it, seems more like taking the kidneys from someone on death row prior to the execution. Does that make sense?

C. Kalb: Yes, thanks.

Coordinator: Dr. Kass, we show no questions.

L. Kass: Well then, let me at this time thank all of you for your interest in the work of the Council and in this report. I look forward to seeing what, if anything, you will do with this.
Also, let me just say for those of you who would like to follow up on this, we’ve had recent conversations with a distinguished biologist, Dr. Markus Grompe, who is at the Oregon Health and Science University, on some of these reprogramming and dedifferentiation studies.

He has agreed to speak with people about the report. He has seen it. He is one of the people who read this document in advance. We did vet this document in advance in earlier draft with several scientists and also with people at the NIH so that they knew what was coming here as well. But thank you again, and I look forward to seeing what you do with this. Good-bye.