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Friday, April 26, 2002


Session 7: Public Comments
CHAIRMAN KASS: Let me ask the Council's consent to — if I'm not mistaken, we have three public comments on the list. Is that correct? Three?

Would Council — rather than take the scheduled break, and then reconvene, since we have I think public testimony from three people, could we take this now and then adjourn afterwards, since we're already together and we don't want to make lots of people sit extra time? If all these people are here. We did say it was going to be at 12:00.

So is Mo Woltering from the American Life League here? And is Richard Doerflinger here? And is Susan Poland here? Is that the right pronunciation.

MS. POLAND: Poland.

CHAIRMAN KASS: Poland? Would you mind going — if we began now? Then, let's go in that order. Mo Woltering of the American Life League, please step to the microphone. It's on.

MR. WOLTERING: I'd like to thank Dr. Kass and all the members of the Council for the opportunity to present these remarks. I'm the Director of Public Policy for American Life League.

My remarks today center around a very simple fact that's been scarcely mentioned in the discussions of this Council and even the larger national and international debate surrounding embryonic stem cell research and human cloning. However, I believe this fact has a profound significance for the discussion that is currently taking place.

The controversy surrounding embryonic stem cell research and human cloning eventually returns to the debate over the moral status and value of the human embryo.

And with this in mind, I would like to ask the Council to reflect for a moment on one simple fact: that human embryos are either boys or girls. This is an indisputable fact that's very seldom mentioned. The human embryo, from the very first moment of life as a single-celled embryo, is either a boy or a girl. That is, either a male or female.

Every high school student, in fact, learns this in biology class. One's sex is determined by chromosomes which are present at the very beginning of one's life as a single-celled creature. So I would ask you to keep in mind that when you are talking about human embryos you are talking about male and female human embryos. Knowing that every human embryo is either a boy or a girl adds an important perspective to the moral status and value of the human embryo.

One's sex is probably the most fundamental component of one's personal identity. And we know this when we reflect upon ourselves. We also know this when we reflect upon our everyday encounters. The sex of a person is the first thing we notice when we meet people on the street, and it's a major determinant of how we interact with people.

We will never be able to empirically confirm the presence of the soul, but we know that in order for a person to exist a living, human body must exist. And we know that human bodies essentially come in only two forms — male and female.

At the single-cell stage, we can identify a living male or female human body. At the most — one of the most fundamental components of personal identity is present at this very beginning stage of life. I believe that this alone is enough reason to recognize the personal rights of the human embryo.

So I think here we must be honest. Many are apprehensive about recognizing the rights of male and female human embryos.

As we all know, many widely accepted practices subject human embryos to death. Here I'm referring to the practices of IVF, embryonic stem cell research, even contraceptive practices which prevent the implantation of the embryo.

Clearly, if we were to boldly recognize the personal rights and the dignity of the human embryo, we must then reject all these practices that I have just mentioned.

The President's Council on Bioethics has a critical teaching opportunity here. History is filled with examples of societies that accepted a mistaken understanding of human dignity, and they allowed horrible crimes to take place against innocent people, yet people came together to correct those mistakes and to defend the dignity of the person.

You have a chance to lead Americans to a renewed understanding of human dignity, and I ask that you overcome all the apprehension. Human embryos are either boys or girls.

Thank you.

CHAIRMAN KASS: Thank you very much.

Richard Doerflinger, United States Conference of Catholic Bishops.

MR. DOERFLINGER: Thank you. I wasn't going to address the Council again, but when I saw such a short list I decided to help the members earn their per diems.

I want to begin by saying how honored I was to be given respectful attention by Dr. Outka in the session yesterday. I want to offer two clarifications on his description of my views there, however. He seems to attribute to me the view that there is no moral difference between destroying so-called spare embryos and specially creating embryos for research that will destroy them.

And he also says that John Robertson accepts my point on that in order to point to the opposite moral conclusion about both.

First, it was really Dr. Robertson's point to which I was responding. My paper was written as a response to Robertson's. But, more importantly, I don't think I've ever argued there's no moral difference between the two practices.

Obviously, I think the practice of specially creating embryos simply to destroy them for research is more morally abhorrent in more ways, just as it would be more horrific to conceive a child solely in order to abort her for organs than to abort in some other circumstances. My point is just that that does not mean the other abortions are morally right.

The point I was trying to make is this: there is often some measure of selfishness in our reasons for conceiving children, just as in our reasons for doing many other things. As a Catholic, I tend to attribute that to original sin.

For example, in having a child, I may have in the back of my mind that I would like this child to go to college and achieve things that I never did, to give myself some vicarious satisfaction. And in that sense, I am treating that child partly as a means.

But this becomes much more problematic if we are treating our offspring as mere means in ways that do them great harm for the benefit of others. And if we explore our reasons why so many of us, quite rightly, strongly object to creating embryos in order to do them harm for research, we will find in our feelings the roots of an argument that it is wrong to harm embryos generally. But I didn't equate the two practices.

Secondly, I wanted to comment briefly on the slippery slope. I wanted to confirm what Dr. Krauthammer said yesterday. During the debate on use of spare embryos in Congress, every member of Congress, every Senator, claimed to oppose specially creating embryos for research, by cloning or other means.

Outside research groups and patient advocacy groups declared the same ethical position, arguing, for example, that the Clinton guidelines on stem cell research kept this research within ethical limits precisely by excluding any involvement in special creation of embryos for research.

But when the debate switched to cloning for research, many of these Senators and outside groups immediately switched their position and endorsed what they had previously condemned.

I am tempted to agree with what Dr. Rowley said yesterday that this was not a slippery slope, that these people always knew where they wanted to go in the end. But that seems to suggest that they were simply being deceptive in their first position and raises the question why we should believe some of their claims now.

The rule "fool me once, shame on you; fool me twice, shame on me" seems to hold here. I do think there was a great deal of insincerity in the earlier claims to share moral concerns of the rest of us about specially creating.

My point is simply that I have no reason to believe that the slope does not extend further down. I want to raise two things about — does this stop with the embryo?

The latest bill, alternative bill to be introduced — and it has been called a compromise by its sponsors, S.2076 — does not, like some previous bills, ban the implantation of cloned embryos in the womb. It allows the implantation of cloned embryos in the womb, as long as that is not done for the purpose of "creating a cloned human being" by which I assume we mean a born human being or the bill would be incoherent.

In other words, this latest bill already endorsed by some Senators would allow implanting cloned embryos in the womb, to grow them to a certain stage of gestation at any time before birth, and then kill them for their organs.

The other reality is that when asked to proffer examples in animal models of what therapeutic claims can be made for therapeutic cloning, supporters have noted two studies. The first involves trying to make new kidney tissue for cows, but it required growing the cow embryos, the cloned cow embryos to fetal stage and then harvest their kidneys.

The second was an attempt to cure an immune deficiency in mice, and that did not work until they actually brought the embryo to live birth and then harvested its adult stem cells for treatment in the original mouse. In fact, there are no models at this point of therapeutic cloning that stays at the embryonic stage.

And I would like to offer for any Council members who are interested a document that offers a little snapshot of the advances that are being made now against some of these diseases without using any embryonic stem cells or cloning.

Thank you.

CHAIRMAN KASS: Thank you very much. If you'd give the documents to the staff table, we'll see that everybody receives these.

The last comment is from Susan Poland speaking as a private citizen. Ms. Poland, welcome.

MS. POLAND: Thank you. Mr. Chairman, members of the Council, my name is Susan Poland, and I work as a library researcher for the Bioethics Library at Georgetown University.

However, I am speaking only on myself and on behalf of no other entity. I'm also speaking from my experience as one of the first 10 women police officers in New Hampshire, and also as one of the first four lab techs in basic reproductive research at the Jones Institute in Norfolk, Virginia.

Recently, I co-authored a bibliography on cloning. Others I had done were on gene patenting and bioethics commissions. So I'm also speaking from what I learned from those.

And I have two basic insights, one comment on terminology, and then I'd like to really spend most of the comment time on illustrating what it was like to be, in 1985, a first-hand account of doing unregulated in vitro fertilization basic research.

First, a clone is a group of genetically identical offspring or progeny. It implies birth, and, therefore, I think that reproductive cloning is redundant, and therapeutic cloning is a misnomer and misleading, like gene therapy is. I would like to see you use the term "IVD" for in vitro division or duplication.

If you're going to have implantation into the uterus in hopes of a pregnancy, IVD/ET, just like IVF means in vitro fertilization, not necessarily followed by implantation, or IVF/ET.

My first comment or insight in working on the cloning bibliography is that the U.S. patent system is the most powerful and most unique law enforcement regulation that this particular government has for controlling research done abroad and in the U.S. You cannot really regulate the scientific research, but you can regulate and control access to the patent system.

And I was expecting or hoping that like you have IRBs or a super IRB for FDA, you would have something like RAC, because the patent system right now is overextended. It does over 10,000 patents applications in one year. It took over 40 years to reach the first 10,000 applications. Those people are not qualified, I believe, for adequately evaluating whether or not research is done correctly under bioethical principles.

Second insight — that was a short-term insight. A long-term insight is that the legacy, I believe, of this group will be its impact on human, and the definition of human to further councils and lawyers in the future, maybe not in my daughter's generation but the generation following that.

If you take a look at what's happening with cooperative robotics, autonomous robots that are making decisions, I wonder if we're going to define "human" as one cell, whether it's an embryo or what, and go back to the racist policies or miscegenation and one drop of blood.

And now I'd like to go into explaining what it was like to be a person that walks into a bioethic — excuse me, into a basic reproductive research laboratory with a background in law enforcement when you had a .38 Smith & Wesson on your hip, but you also had some experience with bioethics and the issues.

The first time I was there they looked at me like, well, are you going to stop the conversation talking about law, or are you going to just tell us what to do as a bioethicist? And I told them, "No, bioethics is not a badge."

Lawyers have — lawyers and policemen have judges. They give you a final decision. Bioethicists and theologians have no judge. And so the discussion continued, and they would talk, and it was a very small group. It was very similar to what I believe 19th century Britain was for discussing science.

We had close communications. I worked with Gary Hodgen, who you may know left NIH in 1984 because he could no longer do embryo research as a bureau chief. And the Joneses — Howard and George-Anna Jones had left Johns Hopkins sometime before because they were no longer allowed to teach because they had reached the age of 70.

So we were working with our small group. And, like I said, I was one of the first four. There were close ties to Patrick Steptoe and John Edwards in England. Everyone knew everything. This was in the age when there were no faxes. Well, they were relatively new. No cell phones, no internet. You were lucky to get things.

And at the time, in the U.S., what had happened with us doing basic research was a scarcity of materials. We were working basically with animals, and, when we could get them, human materials. But because of the fall of the Marcos regime, we were not allowed to get very many primates. They are very hard to get. And when you could find a monkey to work on, if you were using human material, just like with vaccines, three times of exposure to human hormonal material would immunize the monkey and you would no longer get valid results.

So, consequently, a good deal of research in IVF was done using the litter-bearing models of mice, which their ovaries do not react the same as, say, a singleton birth.

At the same time when we were sitting there, I remember one of the business meeting discussions like, well, what do you think? Do you think we should screen for AIDS? That seems to be a new disease. And you know what has happened since then.

I also sat in a meeting with Etienne Balieu, who was running Roussel-Uclef. We were doing work on RU-486 with one other woman. It was a small group of men and us two women. We were the only two people that thought we still agree with diaphragms, because we like control of our own bodies. Forget about giving us drugs that we can't shut out or whatever.

At the same time we were working with RU-486 on monkeys who were giving still birth, or the newborns would die relatively soon, Roussel-Uclef had signed an agreement with the Chinese government to test on people. When you have a policy of one birth or less, it's very easy to allow your people to go sterile.

Also, at the same time, in the summer of 1985, a professor named Akira Iritani, who is still in practice and still working today, came over. And it was sort of like the beginning of 2001 when you see the bone going up in the air from the cave man, and you see the space ship.

We had just gotten our first micromanipulator, a Japanese machine that Professor Iritani had used quite a bit. He had a graduate student, much like Briggs & King — King being the expertise for Briggs with all the insight. He had a graduate student when he showed us at the end of his term staying with us that could do two to three hundred embryos in an afternoon, splicing them, which we would call now embryo-splitting or blastomere separation.

And one of the slides at the very end was a picture of five identical goats born by an eight-cell embryo. And I thought my God, there you have the perfect drug testing system for a pharmaceutical company. I have as yet, as a professional researcher, to see anything in print. If you have any sway with people at the NIH, both at NLM and with research to get more Japanese work put out into the U.S. mainstream for people to know, that would be very nice.

China obviously takes one view based on a Confucian and socialist system, or a Communist system, rather, of human life. Japan takes a different view. Professor Iritani shocked even me when I discovered that in January this year he announced that his group and a different university is viewing genetic engineering — had actually inserted a spinach gene into a pig, and then produced two successive birth generations. From my Western mind, I don't mix plant and animal kingdoms.

And then, lastly, back in 1985, we were there watching what was happening in 1984 with the Medical Infertility Procedures Act when it was passed in Australia in Victoria. And the "hot dogs and cowboys" were going to be put in their place by the legislators.

Well, they certainly did. They emigrated to the U.S. as IVF Australia, became IVF America, and today they are now IntegreMed, Incorporated, responsible for one-sixth of all IVF births in the U.S., and our local outlet is Shady Grove Adventist Hospital.

So I feel that when Australia came into the U.S., what basically we lost was that very close-knit tie of research and clinical care, because it suddenly overwhelmed the system and it became just clinical care and consumers.

When I was working there in Norfolk doing basic research, we got human materials. There was a pecking order. Any human material was first used for patient care, and those people there would decide which ones were the best ones with the best opportunity of going on to help these people that wanted to have babies.

Anyone else would come second for research, mind you that not the best-looking embryos always were the best ones that went and implanting. So we had to rely on their judgment.

We did use cadaver eggs. I'm grateful for the one woman that did donate her ovarian tissue. But the eggs, of course, were dead, as I believe many of the 100,000 embryos are that are sitting around in the nitrogen tanks throughout the country.

But both groups, the clinical practice and basic research, were in service together on improving care. I've never seen such a group of remarkable people with high esprit de corps.

And there wasn't a feeling that this is a researcher-subject relationship or a doctor-patient relationship. We were more or less fiduciaries, trying to do best for individual people and yet also trying to do best for society by improving the science.

My own feelings about the moral evaluation of this, having been given the power to use my own judgment when I was 23 to use deadly force to kill a person if I had to, was that this wasn't destruction of embryos. This was actually loss. There was a real grief every time we had to kill an animal or lost an embryo that we just didn't work.

I'm sorry. Am I over my limit? Is that just some —

CHAIRMAN KASS: No, that's just some — that's just some —

MS. POLAND: Okay. And today I know that talk about the Human Embryology Authority and CCNE in France, while they have asked and joined Germany to put a ban through, or look at regulating human embryo research and, in particular, cloning, they also — the CCNE has asked the President to look at establishing its own authority like the HEFA.

They also use, by the way, the British term, which is cellular nuclear — cell nuclear — CNR. I'm sorry. Cell nuclear replacement I believe is what it is.

I was going to ask you, and then respectfully request, and actually I think the term I want is beg — beg you to regulate this. It was very scary to do IVF, which is fertilized or sexual reproduction, and now you're looking at in vitro asexual reproduction. To do it in an unregulated atmosphere because you didn't know what you were going to do, if you were going to hurt someone, and where the government would draw the line suddenly.

And that's about all I can do is ask — there's a balancing mechanism. My own — as I started to say, my own moral feelings about this, having been given deadly force, I have discovered have changed. And they evolve the more and more information I take in.

Thank you.

CHAIRMAN KASS: Thank you very much.

Did you want to say something, Janet?

DR. ROWLEY: I just wanted to correct Ms. Poland in terms of the definition of cloning, because cloning has been used in the biological community for many, many years. And its first use is — that I am aware of was really when you had a cell line, you knew that it was heterogeneous, and you wanted to take the cells in that cell line and begin new cell lines derived from a single cell, and that was called cloning.

So that, then, you had a homogeneous cell line derived from this heterogeneous cell line. So it in no way implies live birth.

CHAIRMAN KASS: Thank you.

Any comments? Could I ask — is Ms. Poland still here? Could I just ask, as a point of information, are you aware of — this is a question, too, as librarian. Are you aware of any overarching study on the practice of IVF along these lines? I mean, has there been any review studies that we — that —

MS. POLAND: On the safety of IVF?

CHAIRMAN KASS: No, not on the safety. Just on, in fact, the practice. I mean, you were talking really something about the unregulated character or the practice, the profession — the society has its own guidelines, which it has — which it has promulgated, and most of the members of that society abide by it. But there are also other groups that do this practice that are not members of the society. Is there any — are there any studies?

MS. POLAND: For clinical care, I'm not aware of any. And by the way, I did give Ms. Zwanziger one cite, which is the Hayflick 1965 cite, which relates to — it's a seminal article about the number of times you can actually reproduce a cell. It's supposed to be 50 generations, and I explained to her about checking to see if additional — but I can look into that if you'd like, if you can tell me later more —

CHAIRMAN KASS: We'll make the request more precise, and we might be in touch with you. Thank you very much.

MS. POLAND: Okay.

CHAIRMAN KASS: Robby George, and then —

DR. GEORGE: Yes. Can I ask Richard Doerflinger a question?

CHAIRMAN KASS: Is Richard still here? Yes, please, Richard.

DR. GEORGE: Richard, since you're here, I thought I could get an answer to a question that frequently comes up, and it's this. Does the position of the Catholic Bishops Conference, or the Catholic Church generally, on the issue of the moral status of the embryo and what public policy ought to be on that depend on a view about the infusion of a spiritual soul in the early embryo?

MR. DOERFLINGER: No. There have been a lot of speculations during the course of Catholic history about ensoulment. Even during times when people thought they were pretty sure based on the biology of Aristotle and the philosophy of Thomas Aquinas that the early embryo was not ensouled, it still rejected abortion as an act that shows disrespect for this developing life that has a human destiny, that God is at the very least forming to prepare for a soul.

The current teaching is that abortion and destruction of embryos is wrong, first of all, because it destroys a living member of the human species, and that that's enough to deserve our respect.

And, secondly, that since we cannot be sure that the early embryo is not — does not have an immortal soul that when you are destroying that embryo you in addition risk the full gravity of killing a human person in the full sense. But ensoulment is not the factor that means the difference between moral right or wrong or even the difference between something that would be seen as an abortion as versus contraception. Is that —

DR. GEORGE: Yes, that answers it. Thank you.

CHAIRMAN KASS: Thank you very much.

Thank you all for your wonderful work, your endurance. The meeting is adjourned.

(Whereupon, at 12:18 p.m., the proceedings in the foregoing matter were adjourned.)





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