The National Academy of Sciences

Press Conference

January 18, 2002

The National Academy of Sciences

2101 Constitution Boulevard

Washington, D.C.

Transcribed by:

CASET Associates

10201 Lee Highway, Suite 160

Fairfax, Virginia 22030

(703) 352-0091

P R O C E E D I N G S

SPEAKER: Please be sure to identify yourself and your media organization.

JOHN ROBERTS (CBS News): John Roberts from CBS News. I have two questions, if I could. First of all, how do you reconcile your recommendation to support nuclear transfer for embryonic stem cells with the belief that many people have that life begins not at implantation in the uterus, but either at conception or first cell division?

DR. WEISSMAN: I will start and either of the panelists can follow. Our report and our charge was simply to investigate the medical and scientific aspects of this subject. We looked at it closely. We read the literature, we heard everything, we looked for any indication that this technology could create something that would be medically unsafe. It was not our charge to think about, talk about, examine ethical issues. We defer to broad societal debates and commissions, like the President=s Panel on Bioethics.

MR. THOMPSON: Understood, but you seem to indicate support in that recommendation that you do not hold the position that the creation of an embryo is the creation of life. Am I correct?

DR. SIEGLER: We didn=t even approach that question. That was not a part of our charge. That was not part of what we were doing.

DR. SINGER: I think perhaps I would say that the Panel would have considered that a philosophical or ethical question, and therefore it was not on the Panel=s agenda.

MR. THOMPSON: Second question. Are you confident that lawmakers can write a piece of legislation specifically and narrowly enough to ban reproductive cloning, but allow therapeutic cloning to go ahead.

DR. WEISSMAN: Mark, do you want to take that?

MARK: I think such legislation has been proposed in the House, as I remember. You recall last summer, the Greenwood bill was considered an alternative to the bill by Congressman Weldon. I don=t know that bill in detail, but I am confident that such a distinction could be made without too much trouble, and has in fact been made in legislation that has already been looked at.

MR. THOMPSON: Even though the President has voiced his opposition to the creation of embryos for stem cell harvesting?

MARK: I=m sorry. Would you repeat the question?

MR. THOMPSON: I said even though B

DR. WEISSMAN: I think that is another question. I think that is a different question.

MR. THOMPSON: But you say that you are confident that lawmakers can write this piece of legislation narrowly enough, but there are enormous political forces who would like to ban the creation of embryos for embryonic stem cell research.

DR. SINGER: I think the answer to the first part of your question is that it could be written, as people have already done, and as pointed out in the report, the main distinction is whether a blastocyst is implanted in a uterus. That is a very clear definition.

With respect to the various political views as to how the bill would be written, that was not something the panel considered.

CHERYL FOLBERG (New York Times): I am Cheryl Folberg from the New York Times. I wonder if you have looked at whether there has been another time in history when scientists have recommended a legal ban on a type of scientific experiment, and also if you could talk to us about your deliberations B because, as you said, that is a serious matter when scientists recommend a restriction on scientific inquiry?

DR. WEISSMAN: I don=t think is we took as a topic other times in history when bans might have bene recommended. All of us have our own opinions from reading history and of course that is highly variable, as is the validity of the historians. So I choose not to answer that one.

MS. FOLBERG: What about, though, your deliberations? Can you talk about them?

DR. WEISSMAN: We had extensive deliberations. As you will read in the report, we had met by conference call twelve different times, we set up a workshop where we invited all of the experts in the field in both of these areas B human reproductive cloning, nuclear transplantation to produce stem cells. We went over it thoroughly and then the Academy has its own review process which Bruce could talk about, which was, let me tell you, extensive. So we had extensive deliberations and I am certain that we covered the data to date available for this subject.

MS. FOLBERG: I would just like to follow up. Was there any unease about recommending a ban?

MARK: Ms. Folberg, the unease is expressed in the report. There clearly was unease. The feeling was that, on an issue that was so profound for both the scientific community and society in general that such a ban, such an extraordinary effort to ban something should take place, that the language we used was you needed compelling reasons, and in the report we described some of the compelling reasons. I also want to call your attention to page 512 in the report, where we considered the alternative. We consider actually two follow-up questions to yours. Would a moratorium be preferable to a ban? And we consider that and reject the possibility even though moratoria had in the past, let=s say, for recombinant DNA research. Second, we raised the question without resolving it about whethe a ban would be legally possible in the United States context? If you look at the makeup of the panel, we heard from lawyers, but there were no lawyers actually on the panel. We leave that question open and we discuss it in the report.

DR. SINGER: In addition to the extensive discussion on that issue that the panel had, the issue was raised again by the then anonymous reviewers. So in fact the Panel revisited that issue during our discussion of responses to reviewers comments.

RICK WEISS (Washington Post): Rick Weiss of the Washington Post. Two questions. First, to follow up on Cheryl=s first, even if you don=t have a definitive historical review done, can you tell me if any of the three of you can think of any previous instance you are familiar with when scientists have asked for a legal ban on an area of investigation by scientists. I won=t hold it to you if it turns out B

DR. SINGER: My family will tell you my history is very weak. So I cannot, but I am not sure that is very significant.

MR. WEISS: Can any of you remember such an instance?

DR. WEISSMAN: I am not sure, Mr. Weiss, that we have actually recommended a ban, as you say, on research. I actually think that what we have recommended banning is human reproductive cloning should not be practiced B

MR. WEISS: But you say in the report B

DR. WEISSMAN: B as a clinical practice. In fact, the report says in five years we think it is mandatory to review the new scientific data that has emerged. So that is a distinction. I think with respect to banning things, clearly research is a very difficult thing, but you see the difference between banning research and delaying the implementation of clinical practice.

MR. WEISS: I am sorry, but in the report, itself, you explicitly say that human reproductive cloning work should be considered research and not a clinical process.

DR. SIEGLER: No, no. If I may correct you, we say that if in the future, after, if new scientific data emerged, and there had been a national debate that the political and religious and ethical implications of this, if ever in the future such a practice were to be permitted B that is what we say. Then it would have to be regarded as a form of human research involving the mother and the potential fetus that was developed.

MR. WEISS: Just to wrap up this question, can any one of you remember when an area of medicine was called upon by a group like this to not be pursued?

DR. SIEGLER: By any group? I am sure at institutions and institutional review boards, mine included, that proposals to do human research, a particular human experiment, were examined and they said, no, it is not ready.

MR. WEISS: Okay, thank you. Just quickly, a second question. How do you anticipate dealing with the criticism that some raise that a ban simply on reproductive cloning, but not on so-called therapeutic cloning, would be too little, too late, since by the time you busted someone for breaking the law, you have a fetus growing in a woman=s womb?

DR. SIEGLER: In a way it is called the slippery slope argument, that if you permit one thing to happen then inevitably you are opening the door to other things including illegalities. The answer is that if reproductive cloning were made an illegal practice, when, if there wee those that were intent on breaking the law, they could do so whether or not you had a ban on nuclear transplantation to produce stem cells, the technology needed to clone mammals is known and can be developed in many laboratories, so I am not sure that if you were dealing with someone who was prepared to do a criminal act, you would heighten the likelihood of that act being done, if it were a criminal act, merely by permitting nuclear transplantation to produce stem cells. I mean, I think you would still run the risk that you described under any circumstances. So I sort of reject the slippery slope argument. We cannot do research because it would open the door to what w would call for as a criminally enforceable ban.

NEAL MONROE (National Journal): Neal Monroe from National Journal. Two questions. First I am wondering, for purpose of scientists, what is the sacrifice in banning efforts to birth a human clone when you say it is very unsafe and it is likely that anyone trying to do it would get sued for any errors. More importantly, I am interested in Dr. Weissman=s emphasis on the use of creating embryos as laboratory models and its importance for research. Is this a shift in emphasis from the use of embryos as a production of stem cells for transplant, and if it is a shift, would it benefit any of the companies you are associated with B Stem Cells, Perlingen and Johnson and Johnson?

DR. SINGER: I will speak to the second part of the question with respect to Johnson and Johnson and Perlingen, both of which are companies on whose boards I sit. Neither one of those companies is involved in stem cell research or has current plans to be so in any way.

MR. MONROE: Would you benefit from the existence of embryos as models in laboratory research?

DR. SINGER: I think it is impossible for me to say whethe, in my lifetime, I would benefit. I think it is important, and the report says this, that this research is at its very beginning. There is a tremendous amount to be done and the course of research is unpredictable. Many scientists have concluded that this is research worth doing, but most of them agree that we cannot predict the outcome. It may turn out to be of no use whatsoever. We just don=t know.

DR. SIEGLER: Let me answer the question for stem cells. I am co-founder of a company called Stem Cells, an a director. The company does adult stem cells only. It has placed its emphasis on taking cells from adults that can be transplanted or researched now. I have no interest in a company that would benefit, and certainly Stem Cells, Inc. would not benefit from this type of embryonic research, or any type. Thee are various reasons why and I could explain them, but I will just say in fact it is a competition rather than a benefit.

MR. MONROE: To go back to that other question, is this a shift in emphasis on focusing on embryos as research models versus embryos as sources of transplantable stem cells?

DR. SIEGLER: SO let me clarify and then you guys can pitch in. Of course, it is an interpretation by you that this is embryo research. SO that aside, we believe that the greatest benefit that we can see, as scientists, for nuclear transplantation to produce stem cells is to get accurate models with real cells from humans who have real disease or the predilection for disease, to let us understand how those cells develop in a test tube, how we can manipulate them. Diseases that have a genetic predilection include cardiovascular disease, all cancers, Lou Gehrig=s disease, Type I and Type II diabetes, and on an on. These are not rare diseases. We are stymied, as scientists, trying to study these diseases only with mouse models. They help a lot, but if we want to move forward to get the kind of information that will be applicable to the kinds of medical advances we need to treat these diseases, then I think nuclear transplantation to produce stem cells is the correct route.

MR. MONROE: Can you give me any idea of the scale of research involved here? I mean because initially, when we were first writing about this, there was much talk of a few stem cell lines. Can you give me a number of times you wold need to do, as you described, transplantation?

DR. SIEGLER: It is going to be hard. His is unpredictable because you don=t know the success rate. Of course we believe that that kind of research will only come about if broader ethical, religious and so on groups, like the President=s Council, would enable that research. Given that it would happen, then I think institutional review boards will look very, very carefully at the scale, just like they look at the scale right now.

SPEAKER: This question comes from web listener A. J. Hostetler, a science writer for the Richmond Times Dispatch, who asks could someone from the panel please address the differences between this report=s conclusions and the report by the Clinton National Bioethics Advisory Commission?

SIEGLER: Let me start, but I very much would like to have Dr. Weissmann respond also. This is Mark Siegler speaking to the Richmond reporter. The two panels had very different charges. The end that the panel under Mr. Clinton was asked to specifically address the ethical aspects of human cloning and came out with an excellent report. I believe it was published in 1997. Our panel was changed in quite a different way, to look at the medical and scientific aspects of human cloning. Each of the panels necessarily had to have some overlap. The NBAC Panel had to consider to some degree the medical and scientific aspects of cloning, which they did. But their focus was on the ethics. Our panel focused on the medicine and science to a much greater degree than did the NBAC Commission, but again necessarily we would not avoid all of the ethical issues hat are associated with any recommendations that we made. But the clear difference between those two panels may not be in the conclusion, but in the process and methods and primary focus.

DR. WEISSMANN: I don=t think I can add much except that to say that was then this is now. New things came up. We needed to understand it. People were proposing directly to clone last year and this year.

SCOTT BERNELL (United Press International): Scott Bernell from United Press International. The report deals only with procedures involving nuclear transfer. Other procedures have been proposed, advanced cell technologies, inducing an unfertilized egg to begin the division process. Is that simply too primitive a process to include in the report? Or would it be something that would have to be re-written into the report as it matures as a process?

DR. SIEGLER: We considered only, of course, nuclear transplantation and science does move fast. I should say something, that you all know that it is wonderful and exciting to read about science the first time it comes out in a journal. And journals like to produce and publish science that is attractive. Of course the media likes to interpret it rapidly. But we, as scientists, must be very, very careful because it is not just the first report that lets you know that something is even scientifically valid. Lots of times we interpret the data from our own viewpoint, and we think we are so right that we publish it. But in fact things get tested and re-tested and independently verified or not, and so I would say you and I and all of us should be cautious about those fragmentary reports. We did ask in this panel to have a review within five years. We did not set five years as a point. If things move rapidly and need assessment, I am sure the National Academies will ask for the next review.

RON SOFFER (Clinical Higher Education): Ron Soffer with the Clinical Higher Education. I was just wondering if there is any specific reason you selected five years as a time period when such a ban should be reviewed, as opposed to, say, three years or ten years?

DR. SIEGLER: I think I just answered that question, didn=t I? It could happen fast, so we said not in five years B within five years. We are pretty sure it will happen by five years, but it could happen in two years.

MR. SOFFER: Following up, just a quick one. Any concern that if such a ban were implemented about discouraging some research? I mean, this would obviously only be effective within the United States. Any concern that some researchers would feel, you know, a chilling effect on science and leave the country? Was that considered at all?

DR. SINGER: In fact, bans on human reproductive cloning are either being considered or are in place in a variety of other countries, primarily I think Western Europe and Japan. To our knowledge, no one has indicated B no one that we know here in the United States scientific community B has indicated that they might undertake such a response, namely to move out. As you have read, I am sure, there are individuals who have said that they would go abroad with respect to the use of embryonic stem cells, and the derivation of new stem cell lines. That has been in the scientific and broader press as well. And there are countries where that is clearly permissible, the United Kingdom being one of them.

DREW SLINE (ABC News): Hi. Drew Sline with the ABC News. How close are scientists really being able to clone human beings in a matter of years, do you think? And how concerned are you about those procedures?

DR. SIEGLER: I will take the first stab at it. When we reviewed all of the animal studies the frequency of successes is astonishingly low and that is even to carry a cloned blastocyst through to birth. Astonishingly low. There is no reason to believe that if it were to be carried out with human cells that the procedure today would be any better. The numbers you should read in the appendix of this report are so low that if you do the math on the number of eggs that would be required alone, it seems to stretch the boundaries of our imagination.

DR. SINGER: I would just add that, for those instances where a fetus has gone to term and an animal has been born, a significant percentage of those have had a variety of medical problems appearing at different times. Most recently we read this week B I think it was either in Science or Nature B that Dolly, herself, has developed premature arthritis. I feel for her. Mine wasn=t premature but it is bad enough. So in addition to the issues that Irv spoke about, about the rate of success, there are additional serious questions about the health of the animals that have been born. And of course with respect to subtle issues, such as behavioral issues, of enormous importance to anyone considering human reproductive cloning, we don=t have any information at all from animals.

SIEGLER: If I may also just have a try, even though the rate of success is low, the risk to both the developing fetus and the mother is very high, I don=t think that that means that the technique may not be tried in the near future, when we hear testimony from three different groups here in Washington in August. They all said, each of them said they were prepared to initiate such an effort within a year. And they are not the only programs that have B I am not sure that they do B but there may be other programs in this country and around the world, that have the technical capability to try to clone a human being. So the question you ask B I am not sure what the exact question was B the likelihood of success would be very low. The risk to all involved would be very high. That does not mean that such an attempt might not be made.

MR. SLINE: What about these three scientists? How is your recommendation going to affect what they are trying to pursue last year?

DR. SIEGLER: These three individuals.

DR. SIEGLER: One of the three is located in the Untied States. One of them is based in Italy and the third one, I am not sure, perhaps in Montreal. If there were an enforceable ban in the United States, presumably it would affect anybody who wanted to make such an attempt in this country. Other countries, you should know, and our report has some information about it, have already banned reproductive cloning. So I am not sure exactly how it would affect the two scientists who might be out of our country.

JOE PALKA (National Public Radio): Hi, I=m Joe Palka from National Public Radio. I have B unfortunately it is kind of a hypothetical B I have two unrelated questions. But the first one is kind of hypothetical. I am wondering if you can cast your mind back 25 years or so and ask yourselves the question, if you had been presented with the available animal and human data that would support the safety of in vitro fertilization, whether you might not have come to the same conclusion, that it was unproven, unsafe and should be banned?

DR. SIEGLER: It is a wonderful question. Because, as I said in my prepared remarks, the assisted reproductive technology field has not been closely regulated. There is a lot of data in that field hat we are not aware of, but what we are aware of is the success of in vitro fertilization, beginning with the Louise Brown case in England. I am not sure how many other cases were tried before Louise Brown, but that one and subsequent ones have proven the effectiveness of the technique. I think we have so much more data. We have so much more data with respect to mammalian cloning than we had with respect to the dangers and risks of in vitro fertilization that the data compels us to take a different perspective than the one that the English physicians took when hey initiated in vitro back in >78, >79.

DR. SIEGLER: Let me just add a comment. If you go back 25 years, Joe, since you gave us the opportunity, you know that that was the time at which there was a big uproar about creating new life with recombinant DNA. Maxine will tell us in a minute about how the scientific community approached that. I just want to make it very clear that there was a call for a ban of recombinant DNA research and it was worked out. Hundreds of thousand of lives, and I am not exaggerating at all, hundreds of thousands of lives of Americans alone are being treated, saved, made better by the results from that recombinant DNA research. So Joe, do you have another question? Let me go to Maxine:

DR. SINGER: I would just say that the history and the topic are really quite different. The thing that that discussion on recombinant DNA has in common with the discussion we are having today is that the scientific community focused on the question of safety. And it was because we could not answer questions about safety that a moratorium was called for, and that was called for because that was the fastest way to get a response. Then subsequently it turned out that legislation was unnecessary because we began to answer some of the questions about safety. The focus of this Panel on safety is coming up with the opposite answer. Unlike the recombinant DNA technology, it is not safe. And of course some of the recombinant DNA technology was also deemed to be unsafe and was either totally stopped or only could be carried out under extremely strict physical containment and biological containment conditions. The situations really are quite different.

MR. PALKA: Just briefly, to ask the other question, you have already alluded to the Academy=s very rigorous review process. You have already alluded to one of the potential sticking points, was this notion of whethe it should be a legal ban. Was that the main issue that came up in review? Or were there other things, because I have to say that the conclusion of this Panel to find human cloning unsafe is not surprising. So were there other things that were contentious in the review process?

DR. SINGER: There were a variety of comment. If you look at the reviewers, you will see that they represent a much broader range of knowledge and predilections than our committee. So for example there were questions raised about the initial draft with respect to whether our description of the current status of assisted reproductive technology was correct. The science, itself, is moving very rapidly and some of it is controversial. We heard from some people who had a different view, different evaluation of certain results with respect to the science. There was discussion also about the way we responded to that part of our charge that asked us to consider the implications of stem cells. Have you ever been on the receiving end of a report review committee at the Academy? Joe, I wish you to keep it that way.

speaker: Two more questions from our web listeners. The first is Greg Kluteson with Salem radio News, who asks in what regard does the National Academy of Sciences hold President Bush=s Council on Bioethics, and would that group=s discussion of moral, religious and other ethical considerations make for biased conclusions, given your statement that you focused on scientific issues in an effort to be clear and honest.

DR. SIEGLER: I will make a small star, but I know Mark is going to say we are pleased that this panel is meeting. We are pleased that this panel represents the pluralism of our society. We are pleased it includes scientists of impeccable repute. Nobody can say ahead oftime whether those people will bring to their discussions knowledge and not just bias. So I think we are really pleased it is getting going. Mark?

SIEGLER: I agree with what Dr. Weissman said. The entire report, from the beginning of the executive summary through the conclusions of the report speaks for the need to have the society-wide discussion about the ethical, social, political implications of cloning, reproductive cloning, and also of nuclear transplantation to produce stem cells. I think such a discussion has to proceed along many fronts, including with representatives here from the media, including a very careful public discussion of these matters. But in that regard I agree exactly with what Dr. Weissman said. I am delighted there is a Presidential Council on Bioethics that is headed up by one of my colleagues, Leon Katz. I look forward to their deliberations and discussion of a number of matters. As you know, the first matter they began with was cloning in their discussions in the last several days. That is precisely what our report would welcome and encourage.

SPEAKER: A final question from the web?

SPEAKER: Finally we have a question from David Kramer of Science and Government Report. It is a related question. He asks should science be a participant in the broad societal debate over the ethics of this issue? Why or why not?

DR. SIEGLER: Could you read that one more time, please?

SPEAKER: Yes. Should science be a participant in the broad societal debate over this issue?

DR. SIEGLER: I would say, of course. Science needs to be a participant, but not the determining force. Mark?

SIEGLER: I mean, you need science to be a participant in order to generate valid information upon which further societal discussion should take place. But also I think you need the value system of science to be articulated as one of the value systems to be represented in the general debate B not the only one, but as one of the values. Scientists come to these issues with values that may be different, systematically, from value systems of, let=s say, non-scientists or ethicists or philosophers or theologians. It clearly is a viewpoint that has to be represented as part of this broad discussion.

SPEAKER: That concludes our news conference. The report, the news release and the opening statements are all on the web www.nationalacademies.org.