Respect for Life Pluripotent Stem Cell Act of 2005

Mr. Speaker, very shortly now the juvenile diabetes people will be coming through the Congress. They do this every year, I believe.

I look forward to this visit with really mixed emotions. These children come in with this disease that has and will change their lives. Many of them are so brittle that they have to have a pump embedded under their skin that pumps insulin, because the sugar may go violently up or down with potentially disastrous effects on the person. Many times a day they may have to get a droplet of blood to determine the sugar level.

They will appeal to us, as they have every year for the past 5 years, please vote for Federal funds for embryonic stem cell research because they believe, like the loved ones of many other types of patients, that there could truly be miracle cures from embryonic stem cells. They will tell us that there are several hundred thousand embryos out there that are frozen in fertility clinics.

I have a daughter-in-law who is going through that process now. They harvest eggs. They fertilize the eggs. First, they have to give a hormone treatment to the prospective mother so that there will be the production of more than just the one egg that is produced normally per month. They will harvest a number of eggs, 8, 10, 12 eggs. Then they will fertilize those eggs, and they will watch their growth in the laboratory, and they will choose two or three of what look like the strongest fertilized eggs, and then they will implant those in the prospective mother.

The remaining eggs are frozen. It costs money to keep them there. The family may pay for that process because these little embryos that are implanted may not take, and they may need to do it again, and frozen, they could last quite a while, and they may want to have another child. So they will pay to keep them frozen for a while; but by and by, time and changes in the family, they will see no further need to keep them frozen. When they cease doing that, then the laboratory must either dispose of the embryos or bear the expense of keeping them frozen.

So each year a number of these embryos are discarded, and there has been an appeal, which has been bought into by some of my very good friends in the Congress, that from a ethical perspective, why should we not get some medical use from these embryos that are going to be discarded anyhow.

That is a tough position to put pro-life people in, and the reason that most, but not all, pro-life advocates are opposed to this is because they view this as the beginning of a slippery slope. Today, you are permitting the use of surplus embryos that are going to be discarded anyhow; tomorrow, you might be producing embryos. They may be stronger, younger. You may be producing embryos just so you can discard them so you could use them for medical research.

I remembered the juvenile diabetes groups that come through, the children and their parents when, in 2000, I went to the National Institutes of Health when they had a briefing for Members of Congress and staff on embryonic stem cell research, the potentials and the challenge. There were a number of staff there. I think that I was the only Member of Congress who was there.

I went there from a somewhat unusual background, a different background than the average Member of Congress, because in a former life, I went to school and got a doctorate in human physiology. I got it not in a medical school but at an arts and sciences campus, and so we had to take a great variety of courses.

Things like limnology and ichthyology and cytology and protozoology and advanced genetics. And one of the courses I took was advanced embryology. And in that course I had an opportunity to study and learn something about the process which is so familiar to anybody who has studied biology in life, that is, the development of the embryo and how this process goes.

I recognized that occasionally in humans in the early embryo, sometimes at the two-cell stage and sometimes later, and you can tell by how the babies present whether they share an amnion or simply share the chorion; how they present at birth you can tell at roughly what time in the development of the embryo did it split. And each of those halves of the original embryo, either one cell if it was a two-cell stage, or multiple cells if it was further along in the development before it split, each half produces what appears to be a perfectly normal baby. We call them identical twins. And there are tens of thousands of them out there and a great deal of scientific interest is in these twins.

And a lot of research has been done, because when you are looking at two genetically identical people, you have an opportunity to make some studies and observations that you would have to use a great many more subjects to make using the usual genetic different subjects.

And so recognizing that you could take half of the cells away from the original embryo and each half produced a perfectly normal baby, I rationalized, gee, it ought to be possible to take a cell from the early embryo and it would not even know it. And that is because all the cells in the early embryo are what we call totipotent or at least pluripotent. Totipotent means they can produce another embryo if you take the cell out, and pluripotent means they can produce all of the cell types that make up the body. By the time they are pluripotent, they have lost the ability to coordinate all of the different kind of cells into an integrated individual, so they could not produce an embryo.

I asked the researchers at NIH, should it not be possible to take a cell from an early embryo without killing the embryo, probably without hurting the embryo, since in every set of identical twins half of the cells have been taken away from the embryo.

And by the way, Mr. Speaker, one of those is a clone. I guess you can decide which one of those identical twins you would identify as the clone, but clearly one of them is a clone, and both of them develop into what appears to be, by observations over hundreds of years and more recently many years of intensive physiological and medical observation, what appear to be perfectly normal human beings.

And so I asked the researcher at NIH, shouldn't it be possible to take a cell from an early embryo without killing the embryo, probably without hurting it? And they said, yes, they thought that should be possible. So a few days after that I happened to be at an event when the President was there, and I knew that he was laboring with a decision, a very difficult decision, of whether he was going to permit Federal dollars to be used in embryonic stem cell research when presently at that time the only source of embryonic stem cells resulted from the destruction of an embryo.

So I told the President about the meeting at NIH and about my discussion with the researchers there, and a few days later I got a call from Karl Rove. The President had remembered that conversation and turned the follow-up over to Karl Rove, and Mr. Rove told me that he had gone to NIH and had spoken with the investigators there, and they had told him that that was not possible. I said, Karl, either they are funning you or they misunderstood your question, because these are the same people that can go into an individual cell and take out the nucleus and put another nucleus in that cell. And they are telling you they cannot take a cell or two out of a big embryo?

So he went back and asked them again and came back and called me a second time and said, Roscoe, they tell me that they cannot do that. I wondered at the time what had happened. And a couple of years later, when the researchers at NIH were in my office, they somewhat sheepishly admitted that they had permitted Mr. Rove to believe something that wasn't quite true. Because what they had told him

was that they weren't sure that they could produce a stem cell line from a single cell taken from an early embryo.

That is exactly what my bill had proposed to do, was to determine, with animals, whether in fact that was possible or not. They had not meant for him to believe that it was not possible to take a cell from an early embryo.

Now, I cannot get inside their head to tell you, Mr. Speaker, why they permitted Mr. Rove to go away with this misconception, I can only tell you that I think that if I were in their place, I would have judged that the President might very well make the decision that it was okay to use these discarded embryos. Because, after all, they were going to be discarded anyhow, and the potential for life-saving medical applications was so great that I think that they may have rationalized that the President was going to issue an executive order which would make possible the use of Federal funds in the study of embryonic stem cells taken from these surplus embryos. That, of course, is not what the President did.

I am happy to be joined this evening by Dr. Gingrey, and I wanted to engage him in a dialogue, because I think that the same kind of an emotional response that might have permitted the researchers at NIH to permit this discussion to result in a misconception by Mr. Rove, that an analogous emotional response on the part of many pro-life advocates makes it very difficult for them to even talk about the potential of any form of embryonic stem cell research because they are so conditioned that the only way in the past that we have been able to get embryonic stem cells was by destroying an embryo, and so they equate any discussion of embryonic stem cell research as requiring the destruction of an embryo.

The President has a bioethics council that published a white paper in which they talked about four different techniques, potentially bioethically acceptable that could produce embryonic stem cells without destroying an embryo. And I wonder what is the best approach, because we want to carry everybody along with us. I want no one to be offended that what we are proposing, what has been proposed as a matter of fact by the President's council on bioethics is a violation of our fundamental belief that life is sacred. Every life is sacred, and particularly the least of these, this totally defenseless embryo. Their life is sacred, and we must protect that.

So the research that I am proposing, that my colleague has been supporting, does exactly that. And I am wondering what is the best way to bring this community along with us so that they understand that there are potential techniques that could be used for producing embryonic stem cells that will not consist of destroying or even hurting the embryo. What do you think is the best way to approach this?

Dr. Gingrey, thank you very much.

There is another consequence of this understandable emotional reaction on the part of the pro-life community, and that is the statement that is made over and over again that we have, I think it is up to 70-some now, treatments or cures from adult stem cells and none from embryonic stem cells; therefore, why would you want to bother looking at embryonic stem cells?

The reason we have 70-some treatments from adult stem cells is we have been working with them for about 3 decades and we have been working with embryonic stem cells for just a little over 6 years. A newborn baby cannot run a marathon, and there just has not been time for the medical community to develop the potential from embryonic stem cells.

I will be the first to tell you that this research may be very disappointing. I hope that it will not be, because these cells really want to divide, and like an obstreperous teenager, they may be very difficult to control. But the hope is that since embryonic stem cells can certainly make any and every tissue and, potentially, organ in the body, they ought to have the greatest potential.

And I wonder what we need to do so that the statement is not repeated that it is really silly to talk about embryonic stem cell research because we have 70-some treatments or cures from adult stem cells and none yet from embryonic stem cells. That is, of course, a true statement, but you need to put it in context. The reason for it is we have been working for more than 3 decades with adult stem cells and just a little over 6 years with embryonic stem cells. And I want our community to have credibility at the end of the day.

How do we meet this emotional challenge?

Thank you very much. I appreciate your mentioning the diabetes, particularly juvenile diabetes.

The deficiency, of course, is in the Islet of Langerhan cells, named after the German scientist who first saw them. They are like little islands scattered through the pancreas. I have no idea why they are in the pancreas. They have no relationship to the physiology of the pancreas; they just happen to be there, and they are not producing enough insulin. But replacing the insulin does not cure diabetes because the person who has diabetes will end up with eye problems, circulatory problems, toes that they lose, gangrene, and so forth.

And these children now are starting out with the absolute certainty that they are not going to have the quality of life of other children because just replacing the insulin does not cure diabetes. It controls many of the effects, but there will still be consequences to the diabetic.

And as you mentioned, there is the hope that with embryonic stem cells we could grow Islet of Langerhan tissues. And you would not have to put those back into the pancreas. You could, as a matter of fact, put them in the groin or under the arm or under the skin, anywhere. They just have to have access to circulation. They will produce the insulin. The circulation will pick up the insulin, and then it flows to the liver and the cells of the body where it does its miracle work.

But this is the reason that they are so enthusiastic about embryonic stem cell research, because of all of the diseases out there. And we spend more money on diabetes than any other disease in the country, and there is probably more debility and suffering from diabetes than any other disease in the country. And that is why they are so adamant in their desire that we permit Federal dollars to be spent, because with the power of NIH and the peer review, and they have created miracles in the past, they hope they can do another one.

I would like to just look for a moment at the physiology, and the chart, boy, this is really abbreviated. I will show you a little more expanded one in a moment.

But the two gametes come together and produce what is called a zygote, and this is the fertilized cell. It now has half the genes from the mother and half the genes from the father. And then that fertilized cell grows through several stages, and they have skipped the morula stage here and they go right to the blastula and then to the gastrula. And here you start the differentiation into the three germ layers.

Every tissue of our body develops from one of the three germ layers: the endoderm, that is what is inside; and the mesoderm, that is what is in the middle; and the ectoderm. Very interestingly, the parts of the adult body that develop from ectoderm is our skin and our nervous tissue. Most of this, by weight, develops from mesoderm. All the muscles, all the bones develop from mesoderm. And here you see at the bottom are derivatives of the ectoderm and the mesoderm and the endoderm, and then the unique cells, the germ cells, the sperm in the male and the egg in the female.

Now, adult stem cells, when you hear people talk about adult stem cells, what they are talking about is a cell down here, and one of the easiest ones to talk about are adult stem cells that have to do with making blood, and these stem cells found in the bone marrow primarily can produce a variety of cells. The polymorpho-nuclear leukocytes, the erythrocytes, the thrombocytes, all of those can be produced.

Now, you can take an adult stem cell and trick it into believing that it has not gone through all of this differentiation, that it is somewhere back here so that it can now make tissues other than just the ones that it was destined to make and the organ from which you took it. And these are the techniques that are used in adult stem cell research and treatment.

The next chart shows a little more detail in this development process, and this shows it in the reproductive tract of the female. Here is the ovary from which the egg is released. And the egg now starts a long journey down through the fallopian tube. It will be 7 to 10 days before it finally implants in the uterus. The sperm, of course, makes its way from the vagina up through the uterus and through the fallopian tube, and it fertilizes the egg. It shows it very correctly here. Fertilization occurs well up in the fallopian tube. A little later down and it cannot be fertilized.

And this shows the production of the zygote. It shows the first cleavage to produce a two-cell mass. At this point these two cells could separate to produce two embryos, two babies. We know them as identical twins. Or it can go on to split into four cells and eight cells, and I will come back to the eight cell in just a moment because that is the one medically that is of considerable interest.

Then it becomes a morula. You see it there, the compacted morula. And then you get the inner-cell mass, which you saw a pretty good picture of in the previous slide. And, of course, what we are talking about is what goes on in the laboratory now in a petri dish. You fertilize it there rather than in the reproductive tract, but the same sequence of development occurs. And they simply take the inner-cell mass out of the embryo and squash it and kill it and take the cells out to produce a stem cell line.

In the laboratory, in in vitro fertilization, they grow the embryos up to the eight-cell stage, and it is at that stage that they have the most luck in implanting them in the uterus of the female. Several years ago in England, a clinic there began taking a cell, and sometimes they got two, from the eight-cell stage, and they did a preimplantation genetic diagnosis on it because if you had the option of making sure that your baby was not going to have a genetic defect like trisomy 21, mongolism, for instance, you certainly would want to avoid that if you could.

They do a preimplantation genetic diagnosis, and if there is no genetic defect, they then take the remaining six or seven cells and implant them, and now worldwide I suspect there have been more than 2,000 babies born.

There is a clinic just outside Washington, in Virginia, and a year ago I spent more than a half hour talking

with two of the physicians there who have been doing this technique. So we now are producing babies with this technique, with the assurance that there will not be any genetic defects.

Another really good use of that cell that you take from that, and I have to credit Mr. Dorflinger with this, the spokesman for the Conference of Catholic Bishops, and he suggested that the most ethical reason for taking a cell from the early embryo, even more ethically defensible than doing a preimplantation genetic diagnosis, would be making a repair kit. That is sort of the goal when you freeze the cord blood, and we had a bill that everybody but one voted for that gave Federal dollars for freezing cord blood.

Those will not be embryonic stem cells. They will be adult stem cells, but at least they are closer to the genetic identity of that person than other cells would be. And more than 2,000 times worldwide now we have had a perfectly normal baby from that process.

So what I had proposed to the people has, in fact, been done. And what I envision at the end of the day in our bill, H.R. 3144, does not support experimentation in humans. It is only animal experimentations to verify that these procedures are, in fact, doable and efficacious and that the embryo is not harmed.

This technique and three other techniques are included in the white paper prepared by the President's council on bioethics, alternative sources of human pluripotent stem cells.

Dr. Gingrey mentioned totipotent and pluripotent, and I would like to spend a moment talking about that. Totipotent means that the cell you take could produce another embryo. Pluripotent means that it could produce all the cells, tissues, organs of the body; but it does not have the capability to organize them into a person. Ethically, if you took a cell that was totipotent, you would simply be creating a new embryo, and so the argument starts all over again. So you need to take a cell from a stage where it is just pluripotent, not totipotent.

I am assured by the research community that no one has ever been successful in developing an embryo with a cell taken from the eighth stage. You see, these cells know, and I use that term advisedly, know that ultimately they are going to differentiate, and apparently that differentiation problem has started well before you see the three germ layers developing, because between the fourth stage and the eight-cell stage, they have lost their ability to be totipotent. They can now only be pluripotent. As Dr. Gingrey pointed out, it is very essential that ethically you take cells that could only be pluripotent.

I have two quick slides here that look at the development of twins. This is the two intercell masses. These are when the twins develop, the identical twins develop later, when it splits later. You can see that because they each have their own amnion. They share a chorion, of course, but they each have their own amnion.

Let me see the next one, which shows how you have what are called fraternal twins. Here you have two eggs produced by the mother, ordinarily only one, sometimes two, sometimes three, but ordinarily only one egg, unless you are giving some hormone treatment. Then those are now presented in separate chorions. They, of course, have their own amnion, which is the tissues around the baby which contains the fluid in which the baby floats, and the tissue around that is called the amnion.

There are four techniques in the white paper. I would like to look at the technique that I have been looking about. Number two in the white paper.

They credit me with suggesting that. There is a little footnote: ``A similar idea was proposed by Representative Roscoe Bartlett of Maryland as far back as 2001,'' and I think I actually talked to the President before that. They say it may be some time before stem cell lines can be reliably derived from single cells. We have two investigators, Landry and Verlinsky, who claim that they have done that.

You see, these cells love company, and they don't behave well if they are alone and they don't have company, so that is why there was the concern that maybe you could not develop an embryonic stem cell line from a single cell. But these two investigators have done it in a very clever way. They provide company for the cells, and then they separate the company, these are other types of cells, they separate the embryonic cells from the other cells that provided company for them to encourage them to continue the division process.

A second technique, as a matter of fact it was number one, mine was number two, the first technique that they talked about is a really interesting one. What this does is to propose the use of cells from an embryo much like we use organs from a cadaver. Everybody is familiar with that, and there are many people that have a will that say you can harvest their organs to benefit somebody if that would be useful.

When you create these embryos in the laboratory, not all of them are robust. A fair percentage of them never make it. They divide through a few stages for a few days and then just die. This proposal is if you determine that the embryo is moribund, and there is pretty good scientific evidence that you can do that with quite some certainty, kind of equivalent to determining a person is brain dead and therefore there is no chance that they can go on with life as we know it, and his proposal is that if you determine that the embryo is not going to make it, that it will die, but before it dies, you then take a cell or cells from the embryo to create an embryonic stem cell line. This is very equivalent to taking organs from a cadaver.

There may be some question as to whether you can get a really good strong cell from an embryo that is in a day or two going to be dead, but it is possible that you could do that. My bill actually asks for Federal dollars to explore all of these techniques with animal models.

I was talking to one of the researchers, Dr. Hurlbut, the other day. This is Dr. Landry's proposal. I noted that I would be enormously surprised if what we found in the great apes was not going to be what we found in humans, and he agreed that he too would be enormously surprised.

It may be somewhat humbling, but we share a vast majority of our organs with the great apes, the chimpanzees and orangutans and gorillas. You have to look to see genetic differences. They have the same number of chromosomes, and we share many, many, most, 90-odd percent of all the chromosomes. So it would be very unlikely that what we found in animals would not occur in humans.

We have a couple more charts that address this. There has been a lot of thought given to this, and I think that we have one; let's look at the one that actually shows the depiction, yes, that one. Let us look at that one.

That shows what happens in these cells, these embryos, in just a couple of days. They go from a perfectly normal looking embryo to a dead embryo, but there are clues that that is a certain result that the experts can see in these cells.

So this is a potentially viable, I believe ethically acceptable technique, very analogous to taking organs from a cadaver. This is simply taking cells from what would be the equivalent in an embryo of a cadaver, an embryo that will not live, that will die.

There is another technique, and I would like to submit two papers here for the Record, and these are papers describing another technique, a very interesting one. This is Dr. Hurlbut's contribution.

Researchers can take an oocyte, that is the egg from a mother, and they can take the nucleus out of that oocyte and place a nucleus from an ordinary cell, like a skin cell, inside the cell, and then with a little shock treatment you can trick the cell into believing that it was fertilized, and it will go on to develop into an individual. That is how we got Dolly the Sheep. It is called cloning.

Dr. Hurlbut's suggestion is, and this is called epigenetic nuclear transfer, that he alters that. The nucleus that you place in the cell has an induced genetic defect. They alter one of the genes so that the result cannot produce an embryo.

There are things that happen in some mothers where you have growths and they will have teeth and hair, but it certainly is not a baby. It is not coordinated. You can turn off this gene so

that what you have produced is not an embryo, could not be a baby.

It is very interesting that the way you turn that off is by RNA, ribonucleic acid, rather than deoxy ribonucleic acid, which is what is in the nucleus and what makes up the genes and chromosomes. The RNA is out in the cytoplasm, and I am not so sure that a clone is going to be that identical to the original because the RNA, the cytoplasmic RNA, is going to be different; and the cytoplasmic RNA has a big influence because it can turn on and turn off genes. This is the technique used for doing this.

This, I think, is from Nature Magazine, one of the premier scientific journals. It is the British equivalent to our Science Magazine. It is really multi-disciplinary and very discriminating in the articles that it prints.

The bottom sequence here shows what he would do. He is producing something that cannot be a baby because the gene that is responsible for the organization of these various types of cells into a coherent human being is turned off. By the way, whether he turns that off in the cymatic nucleus before he puts it in the cell so you avoid the argument that you are altering an embryo, because it is not an embryo, it is just a nucleus from a skin cell and he turns off the gene there, and then he takes the cell out of an oocyte and places this nucleus from the skin cell with the genetic alteration, places it in there. This is also a potentially viable technique.

All of these, by the way, you can argue that you may have some ethical problem with it. You may argue that you are intentionally creating a freak here just so you can harvest the cells from it. But since you are doing this before you place the nucleus in the oocyte, you are simply altering the nucleus in a skin cell, I think you can get by the ethical arguments.

Let us go back for a moment to the ethical arguments, because they are very important. I want to make sure that sensitivities of nobody in the pro-life community are violated.

The technique that I suggested to the President and the one that is described in our bill, we would not get the stem cells until several things had happened over which we have no control and no influence. The first thing is that a couple has decided that they are going to do in vitro fertilization. In addition, they have decided that they want to create a repair kit for their baby. They may or may not decide that they want to do a pre-implantation genetic diagnosis.

By the way, you can do both of those in the same cell. You simply culture the cell and you have now more than one, ultimately many, so you can take a cell for pre-implantation genetic diagnosis. They will have made the decision they want a repair kit. All we are asking for is a few surplus cells, one will do, a few would be better, a few surplus cells from their repair kit.

What this would do is provide for that baby, then a child, then an adult, throughout its life the potential that if it had diabetes, you could develop other Langerhans cells from its repair kit that are genetically absolutely identical to the person so there would now be no threat of rejection. This would clearly, clearly be miracle medicine.

I think we have gotten by the ethical objections, because whether or not you believe that parents ought to use in vitro fertilization, these parents have decided to do that. Whether or not you believe they should take a cell to produce a repair kit, these parents have decided to do that. So they have already made those two decisions, both of which I think are ethical.

Parents really want a child when they will go to the extent of in vitro fertilization. As I mentioned, my daughter-in-law is going through that. And after the surgery for harvesting of the cells, she cannot even drive a car for quite a while. This is not a casual procedure.

So these are loving parents who want a child. And I think it would be very rational that they would want that child to have a repair kit if they could, and we are simply asking for a few surplus cells from the repair kit.

I should mention the fourth procedure that is in this white paper, and that is the dedifferentiation of the adult cells. This dedifferentiation is a play on differentiation, and what happens is that the single cell produced by the union of two gametes, called the zygote, this cell now differentiates. It produces tissues that are endoderm, from which the lining of your intestinal tract and lungs and the lining of your blood vessels will come, the mesoderm and so forth. So they have differentiated.

You can now potentially get the equivalent of an embryonic stem cell if you can simply take one of these adult cells and trick it into believing that it has not differentiated. What you will do is dedifferentiate it.

I do not know how consistently you can do that, but that is why we need to do the research. On occasion you can do that, and I do not know how consistently you can do it. I do not know how viable the tissues will be once you have done it, but that is the reason that you do research.

I would just like to again mention that our bill, 3144, does not provide any Federal funds for any work on humans. It is only animal experimentation. And it would provide Federal money for working on all of the techniques that the President's Council on Bioethics indicated might be ethically acceptable under the right circumstances.

Of course, one of the things that is very much involved in whether it is ethical or not is, does it do harm to the baby? And that is why the animal experimentation first. We want to make sure that in fact these techniques can occur. We want to make sure that there is no negative effect on the embryo.

There should not be, Mr. Speaker, unless you think that identical twins are somehow deficient, there should not be any medical effect, because we have, over hundreds of years, tens of thousands of identical twins, all of which appear to be perfectly normal human beings.

The potential for healing, medical applications in embryonic stem cells is just incredibly great, which is why the big interest in this. It is why the people at NIH would really like funding for this. It is why the groups that will come to see us, the juvenile diabetic groups that come to see us, will be advocating so strongly for research with embryonic stem cells, because this really could be a big, big breakthrough.

It could provide miracle cures that we can only dream of today. We need to make very sure that we are not crossing ethical bounds, that we are purely ethical.

Mr. Speaker, I am very concerned that none of my friends in the pro- life community be offended by any of this research, which is why the animal experimentation first, with a clear bioethical look at this.

I appreciate very much this opportunity to discuss this. Mr. Speaker, I include for the Record the articles I referenced earlier.

Production of Pluripotent Stem Cells by Oocyte Assisted Reprogramming

As described in the President's Council on Bioethics'

recent White Paper, altered nuclear transfer (ANT) is a broad

conceptual proposal for producing pluripotent stem cells

without creating and destroying embryos. In the description

set forth below, we outline a research program for a form of

ANT that should allow us to produce pluripotent stem cells

without creating or destroying human embryos and without

producing an entity that undergoes or mimics embryonic

development. The method of alteration here proposed (oocyte

assisted reprogramming) would immediately produce a cell with

positive characteristics and a type of organization that from

the beginning would be clearly and unambiguously distinct

from, and incompatible with, those of an embryo. Incapable of

being or becoming an embryo, the cell produced would itself

be a pluripotent cell that could be cultured to establish a

pluripotent stem cell line. Significantly, this cell would

not be totipotent, as a zygote is.

Our proposal is for initial research using only nonhuman

animal cells. If, but only if, such research establishes

beyond a reasonable doubt that oocyte assisted reprogramming

can reliably be used to produce pluripotent stem cells

without creating embryos, would we support research on human

cells.

With few exceptions all human cells contain a complete

human genome, i.e. the complete DNA sequence characteristic

of the human species. Specifically, one-celled human embryos,

pluripotent human embryonic stem (or ES) cells, multipotent

human adult stem cells, and differentiated (specialized)

adult human cells such as neurons all contain a complete

human genome. Thus, possession of a human genome is a

necessary but not sufficient condition for defining a

human embryo with its inherent dignity. Rather the nature of

each cell depends on its epigenetic state, i.e. which subset

of the approximately thirty thousand human genes is switched

on or off and, if on, at what level. For example, the gene

for albumin, a liver specific protein, is found both in human

embryos and in adult human liver cells called hepatocytes.

However, neither the messenger RNA (mRNA) for albumin nor the

protein itself is found in single-celled embryos because in

them the gene is silenced.

This fundamental observation has given rise to the concepts

of cell fate plasticity and epigenetic ``reprogramming.'' If

successful, reprogramming converts a cell from one kind to

another by changing its epigenetic state. The ability to

clone animals, such as Dolly the sheep, by transfer of a

specialized adult nucleus to an enucleated oocyte

demonstrates the power of epigenetic reprogramming: the

oocyte cytoplasm is sufficient to reprogram the somatic

nucleus to a totipotent state. Human cloning has been

proposed as a means of generating human embryos whose

pluripotent stem cells would be used in scientific and

medical research. Here, through a form of altered nuclear

transfer, we propose to utilize the power of epigenetic

reprogramming in combination with controlled alterations in

gene expression to directly produce pluripotent cells using

adult somatic nuclei, without generating and subsequently

destroying embryos.

How do pluripotent stem cells differ from totipotent

single-celled embryos? Several key transcription factors

essential for establishing and maintaining the pluripotent

behavior of ES cells have been identified. Importantly, some

of these are specifically expressed only in pluripotent

cells, such as embryonic stem cells or the cells found in the

inner-cell-mass (ICM) of the week-old embryo or blastocyst.

They are not expressed in oocytes or single-celled embryos.

Expression of these factors therefore positively defines and

distinguishes mere pluripotent cells from embryos. These

factors instruct a cell to have the identity of a pluripotent

cell. Currently, the best studied example is the homeodomain

transcription factor called nanog (Mitsui, Tokuzawa et al.

2003*). Nanog is not present in oocytes or single-celled

embryos, but first becomes expressed weakly in the morula

and then highly in the ICM (Mitsui, Tokuzawa et al. 2003;

Hatano, Tada et al. 2005). Deletion of nanog does not

prevent early cleavage stages of embryogenesis including

formation of the ICM but does prevent the formation of an

epiblast (Mitsui, Tokuzawa et al. 2003). ES cells in which

nanog is blocked lose their pluripotency--which clearly

shows that nanog is a positive factor instructing cells to

be pluripotent, i.e. to behave like an ES cell.

Furthermore, ES cells which constitutively express nanog

can no longer be differentiated, i.e. are forced to remain

in their undifferentiated state (Mitsui, Tokuzawa et al.

2003).

We propose a procedure that combines epigenetic

reprogramming of a somatic nucleus with forced expression of

transcription factors characteristic of embryonic stem cells,

to produce a pluripotent stem cell. As a result of this

procedure, nanog and/or other, similar factors, would be

expressed at high levels in somatic cells prior to nuclear

transfer, to bias the somatic nucleus towards a pluripotent

stem cell state. Such altered nuclei would then be

epigenetically reprogrammed by transplantation into

enucleated oocytes. Alternatively or concomitantly, the mRNA

for these same factors could be introduced into the oocyte

prior to nuclear transfer. This procedure could ensure that

the epigenetic state of the resulting single cell would

immediately be different from that of an embryo and like that

of a pluripotent stem cell: the somatic-cell nucleus would be

formed into a pluripotent stem-cell nucleus and never pass

through an embryonic stage. Therefore, unlike some other

proposed methods of ANT, this method would achieve its

objective not by a gene deletion that precludes embryonic

organization in the cell produced, but rather by a positive

transformation that generates, ab initio, a cell with the

distinctive molecular characteristics and developmental

behavior of a pluripotent cell, not a totipotent embryo. This

should allow us to produce a pluripotent stem cell line with

controlled genetic characteristics.

Madam Speaker, there have been a number of articles in the recent press relative to stem cell research, with particular reference to embryonic stem cell research. I thought it might be well in starting this little discussion to take a look at what we mean by stem cells.

I have here a chart which shows in very abbreviated form the development of an early embryo. It starts out with the zygote, which is the fertilized egg; and then it skips a couple of stages of development, and it goes through the blastocyst, and then it goes to the gastrula. By the time the embryo gets to the gastrula stage, the cells have already differentiated to the place that we have three different kinds of somatic stem cells. This is the ectoderm, and the mesoderm, and the endoderm, and then those very specialized cells, which in the female will be the germ cells in the ovary, the ova, and in the male will be the millions and millions of sperm that are in the gonads of the male.

If we look back, Madam Speaker, at these stem cells that are present here in the gastrula, where we have these three, as we call germ layers, we see the ectoderm can further differentiate into skin and nervous system and some of the pigment cells in our body; and then the mesoderm, the middle layer, that differentiates into what is most of us by mass and weight, cardiac muscle, our big skeletal muscles, the bone, the smooth muscle, all of our blood, and the blood is an organ, it happens to be a liquid organ that is dispersed through the body; and then the endoderm. This is much more limited in volume and in variety, but still very important. The pancreatic cells, the thyroid cells, the lining of the gut, the lining of the lung and so forth.

It might be worth just a moment, Madam Speaker, to take a look at our next chart, which kind of puts this in context. We started out with the zygote, which is the fertilized egg here, and we ended up with the inner cell mass with these three germ layers. What we show here are all the stages that were omitted in that first chart. This is one-half, as the little diagram here in the upper left shows, of the reproductive tract of a female. It shows the ovary on one side and the fallopian tube, with the funnel-like opening here called the infundibulum. Then it shows the fallopian tube on down to the uterus itself.

What it shows, Madam Speaker, is that fertilization takes place well up in the fallopian tube, and that begins day one. And then as the egg slowly moves down the tube, it splits first into two cells, then four cells, and then eight cells, and then the larger variety of cells, and finally where you have the inner cell mass and then to the gastrula.

There are two kinds of stem cells, adult stem cells, and those are derivatives of the cells that we showed in the previous chart. For instance, in the humans we have adult stem cells in our bone marrow. These are cells which are differentiated to the point that they will produce a limited variety of cells, but still undifferentiated to an extent because these stem cells in the bone marrow can produce red blood cells and polymorphonuclear leukocytes, part of the white blood cells, and the thrombocytes, those are the cells, the platelets as we call them, that are associated with clotting. And there are a number of adult stem cells similar to that that still retain some of the capability for producing more than just one kind of cell.

We have been working with adult stem cells medically now for more than 3 decades, and there have been a number of medical applications, treatment of humans that have been made with adult stem cells. But just because they are what they are, Madam Speaker, a great number of people believe that there should be more potential from the embryonic stem cells simply because they can produce any and all of the tissues of the body.

Since we have been working with embryonic stem cells for now just a little over 6 years, we have not had the opportunities for medical applications we have had in adult stem cells, but this does not dim the hopes of the scientific community and the medical community that ultimately there may be more and better applications of embryonic stem cells to treatment of diseases than adult stem cells, simply because of what they are, puripotent cells retaining the ability to produce any and all of the tissues of the body.

It is possible, Madam Speaker, that this characteristic, which makes them so potentially attractive and exciting, may be uncontrollable. They may be so bent on dividing that we cannot control their division. They may end up producing tumors and cancer-like growths in the organism in which you put them.

But if that can be controlled, the medical community and the researchers associated with it believe there is potential for enormous applications to medicine of embryonic stem cell research. We have now had 58 applications of adult stem cells in helping to treat some of the diseases.

What are the diseases that could be treated with stem cells? Ordinarily, one thinks that the greatest potential for the use of stem cells would result from use in diseases from tissue deficiency rather than diseases that result from some organism, although if there is an infection in the body and a tissue is damaged, there is the hope that it might be replaced with stem cell application. There are a number of diseases that the scientific community and the general public believe might be amenable to treatment with stem cells, particularly embryonic stem cells.

Diabetes is one of those. This is the most costly disease in our country. It costs more to treat the diabetics in our country than any other single disease. I have these come through my office. Particularly heartrending are the little children that come there, 5 and 6 years old some of them, such brittle juvenile diabetics that they have an implanted pump and they have to prick their finger or some part of their body a number of times a day to monitor the glucose level so that just the right amount of insulin can be injected to control this.

This insulin is produced by cells called island of Langerhan cells. Dr. Langerhan was the German scientist that described them. And they look like little eyelets because they are simply distributed through the tissue of the pancreas. The pancreas is a very large gland at the very beginning of the small intestine that secretes all of the different kinds of digestive enzymes so that fats, carbohydrates, and proteins all are digested using the enzymes secreted by the pancreas.

I have no idea why nature placed the islets of Langerhans in the pancreas. They could be placed anywhere. With these stem cell applications if we could create islet tissue, they could be placed in the person. It could be placed in the groin, under their arm, under the skin, anywhere. It does not have to be in the pancreas. This islet tissue could then make insulin which would cure diabetes. When you give insulin to the diabetic, it delays progression of the disease, but it does not cure it. A person with juvenile diabetes faces the prospect that they probably will have a shortened life, problems with their vision as the vascular bed in the back of the eye breaks down, and they may

have problems with circulation in their extremities, particularly in the feet where there is some difficulty getting blood back uphill to the heart.

As many people in this country know through relatives and friends, this results frequently in sores that do not heal and results in gangrene, so the toes or a foot may need to be taken off. Diabetes is one of the diseases that is very attractive as a potential for use of stem cells, because if we could just produce islet tissue, we could cure diabetes, the most expensive disease that we have.

Another disease is multiple sclerosis, and if impaired cells could be replaced through stem cell therapy, then the person could walk again.

Lou Gehrig's disease, I remember my grandmother was tripping and falling, and they did not know why. It took them quite awhile back, this was a number of years ago, to determine she had Lou Gehrig's disease. I remember as a teenager going to her bedside. She was maintained in the home. She slowly deteriorated, losing first one muscle function and then another. Finally, at the end, the only muscle function she had remaining was the ability to blink her eyes. It was once for yes and two for no, as I remember. She could not swallow and had indicated she did not want to be force fed and ultimately she died from starvation with this disease.

Well, anybody who has a friend or a relative that has gone through that kind of experience has to be enthusiastic about the potential for stem cell therapy. This was a number of years ago, but if it were tomorrow or the day after tomorrow figuratively, maybe there could be stem cell therapy for my grandmother, and she would not have to have died at the relatively young age she died at.

Alzheimer's disease is another one. President Reagan died from Alzheimer's disease. Victims do not even recognize their favorite loved ones, have no memory and may wander outside and wander off.

There is a whole category of autoimmune diseases. I have a paper which lists 63 of the autoimmune diseases. By that, I mean a disease where the body gets confused as to what is the body and what is not the body.

When we are developing as embryos in our mother's womb, there are certain cells in our circulatory system called T-cells located in the lymphatic tissue, and the T-cells are imprinted with who we are because once we get out of the mother's womb, we are going to be in a hostile environment, exposed to bacteria and viruses, and so it is important that the body knows what it is so the defense mechanisms in the body can be marshaled to eject the intruder.

These T-cells identify what is you and what is not you, and they alert some of the specialized cells in our white blood cell system so they are attracted to the site, and they eject, they may consume, they eject the intruder.

There are 63 distinct autoimmune diseases. For some reason, the body gets confused and the autoimmune system gets confused and starts attacking your joints, for instance. We know that disease as arthritis.

I remember my first real introduction to this big list of autoimmune diseases was a secretary I had, a very vibrant young lady whose life was really, really changed because she had lupus. There are many Americans who have family or friends who have lupus, and lupus was one of the first autoimmune diseases that was discovered.

There is a controversy going on over the potential for embryonic stem cell medical applications and adult stem cell medical applications. We have been working for more than 3 decades with adult stem cells, and our very able medical scientific community has been able to develop a number of applications that can cure or at least lessen the severity of disease using adult stem cells.

Since we have been working with embryonic stem cells for only a brief period of time, we do not have any direct applications to medicine of embryonic stem cell therapy, but that does not dim the enthusiasm of the medical community because they believe that the potential there ought to be greater.

But the real problem here is that up until this time the only way that we can get embryonic stem cells is to destroy the embryo. The scientists go into the inner cell mass stage. That is this stage here, day five. Of course, what we are doing now in the laboratory is not done in the uterus. All of this is done in a petri dish. The in vitro is in glass. In vivo means life. The embryo is destroyed at the inner cell mass stage, and cells are taken to produce a stem cell line.

About 4 years ago, this produced a real dilemma for the President who, like all of us, has family and friends who have one or more of these diseases that could be potentially ameliorated or cured by embryonic stem cell application. Yet the President knew the only way we were presently getting embryonic stem cell lines was by destroying embryos. He, as I am, is a strong pro-life advocate and the President had a problem with taking one life because that embryo produced in the laboratory in surplus and in vitro fertilization had the potential when implanted in a receptive mother to become a baby and the President's problem was that he had a moral problem with taking one life with the hope of helping another.

While the President was wrestling with this problem and what to do about it, there was a briefing at the National Institutes of Health for Members of the Congress and for their staff. I went out there to that briefing.

As the next chart shows, when we were talking about the potential for embryonic stem cell lines, I remembered my training of more than 50 years ago when I got my doctorate at the University of Maryland and had a course in advanced embryology and then went on to teach medical school for 4 years and postgraduate medicine doing basic research at the National Institutes of Health. I remembered what everybody knows, because they had the course in advanced embryology it was in my mind, that whenever we have identical twins what has really happened is that half of the cells have been taken from the early embryo. The half that is taken becomes a perfectly normal baby, and the half that is left becomes a perfectly normal baby.

Madam Speaker, one is a clone. When one thinks about cloning, remember that Mother Nature or God, to whomever you want to subscribe it, has been cloning for a very long time. Now these early embryos can split either at the two-cell stage or at the inner cell mass stage or anywhere in between, presumably.

We know at least at those two extremes because we can tell by how they present at birth when they split. If they share an amnion, they split at the two cell stage. If they have separate amnions, they probably split at the inner cell mass stage.

So knowing that half of the cells could be taken away from an early embryo without harming the embryo, unless you think identical twins are somehow deficient, and I have talked with a number of identical twins, and I have not talked with any of them who thought they were less a person or deficient because half of the cells were taken away to produce the other identical twin.

It occurred to me that you ought to be able to take cells from an early embryo without hurting the embryo to develop a stem cell line from that early embryo. I mentioned this to the researchers at NIH, and they said, yes, that is theoretically possible to do that.

Just after that, I was at an event and the President was there and when I went through the line, I mentioned my visit at NIH and the response that they had given to my question. A few days later, I had a call from Carl Rove and the President had turned the pursuit of this suggestion over to Carl Rove. Carl told me that he talked to the people at NIH, and they tell me what you have suggested is not possible.

Carl, I said either they are funning you or they misunderstand you, because these are the same people that can take a single cell and take the nucleus out of that cell and put another nucleus in it. That is what they did with Dolly the sheep and the large number of clones that have been produced since then.

I said, of course, if they can take the nucleus out of a cell and put another nucleus in it, they can certainly take a cell or two out of what is a relatively big embryo. So he went back and asked them again and then called back and said they are still telling me they cannot do that. So a few days later, the President came out with his executive order.

Madam Speaker, you may remember this was kind of a decision like Solomon might have made. Obviously, from the potential efficacy of embryonic stem cell research and medical applications, it is very desirable that we do that.

On the other hand, if the only way to get embryonic stem cells is by destroying an embryo, then you are left with the quandary of, is it really acceptable to destroy one life with the hope that you are going to help another?

So the President came to a decision that I think represented great wisdom. He recognized that a number of embryos had already been killed, destroyed to establish stem cell lines, and since you cannot turn back the hands of time to change that, these embryos were gone, the stem cell lines were there, and so the President, recognizing the potential for embryonic stem cell research, and being concerned that you should not take one life with the hope of helping another, wisely I think, said we could spend Federal dollars on any exploration we chose with the existing stem cells lines, and he thought there were about 60. There have never been 60, but he was told there were something like 60 stem cell lines, and Federal dollars could be used for research on those lines, but no Federal dollars could be used for developing or destroying any additional embryos for stem cell lines.

This was about 4 years ago, and as we knew, the scientific community knew, as I knew because of my background, these stem cell lines would eventually run out. Stem cell lines, like people, age. For reasons that we may not understand, they do not last forever. Those stem cell lines, Madam Speaker, are running out. We now have, I think the accepted figure is 22 stem cell lines left, and all of these are contaminated with mouse feeder cells. This is the result of a technique which is used to facilitate the replication of these cells in the tissue culture, and they are now all contaminated with mouse feeder cells so that although they are perfectly good for research and a lot of research is being done, they are not good for medical application because you would not want to put the cells contaminated with mouse feeder cells in a human.

So what now? One of the potential solutions to this problem is included in H.R. 810, the Castle-DeGette bill; and the argument made in this bill is that there are about 400,000 surplus embryos out there from in vitro fertilization. You see, to make sure that the doctor is going to have a good embryo or two or three to implant in a mother, because they do not all take, he will produce more embryos than he will probably need. Then he will look at them under the microscope and pick the strongest looking of those embryos and may put two or three or so in the mother.

One of our Members, the Rohrabachers, are now the proud parents of triplets from in vitro fertilization. All of them grew and so they are now the proud parents of these very happy and healthy little babies. Since there are 400,000 surplus embryos out there that are frozen, the argument is, and this is the argument of the bill, that since these embryos, at least many of these embryos, realistically most of these embryos will ultimately be discarded, they will not stay frozen for 49 years there, they will not last forever, and by and by they will be discarded, and so the argument is, why should medicine not benefit from cells, from embryos that are going to be discarded anyhow? That to many people is a compelling argument. It was a compelling argument to a majority of people in the House, and now they are considering this bill in the Senate.

But to those in the pro-life community, there is another way of looking at these embryos. I am at the microscope and there is an embryo under the microscope there. That embryo could become a snowflake baby. More than 100 times parents who do not have an ovum, cannot get pregnant any other way, have adopted these surplus embryos and we have more than 100 of what we call snowflake babies. The embryo that I am looking at under the microscope might be adopted and that could be any one of the 400,000 embryos, and it might be the next Albert Einstein. How could I destroy an embryo that might be adopted and might be the next Albert Einstein? So this is the argument on the other side, which is why the great debate over H.R. 810.

As a result of a series of discussions with the White House and with a number of the interested groups, we have developed a bill which is called H.R. 3144, the Respect for Life Pluripotent Stem Cell Act of 2005.

Madam Speaker, I will make this short bill a part of the Record.

Madam Speaker, the gentleman from Georgia (Mr. Gingrey) has joined us. I would like to yield to him before I go through the history of how we got to this bill and the people we talked to

and exactly what is in the bill. I thank the gentleman for joining us.

Madam Speaker, reclaiming my time, I want to thank my colleague very much for his comments. He is very generous. I did not come to the Congress, and that was 13 years ago, until I was 66 years old; and I am very fortunate to have some prior life experiences that have permitted me to understand some opportunities here in the Congress that might not have been so obvious to others who did not have this background.

After the President came down with his executive order, I continued to meet with the folks at NIH, and I subsequently learned, by the way, I need to come back to that problem with Karl Rove and his discussion with the NIH people, and this was a typical example of failed communications. And so often we think that we are carrying on a dialogue and we are really carrying on simultaneous monologues.

However it happened, what the NIH people were telling Karl Rove was that they were not sure that they could make a stem cell line from an embryo that early. That is true. That is why in our bill we advocate animal model research rather than beginning with humans. But there is no reason we should not be able to do that.

Now, as a matter of fact, a Russian scientist working in this country, Verlinsky, says he has, in fact, done that. I have met a number of times with people from NIH. On July 20 of last year, for instance, we had an extended meeting in my office with representatives from NIH, with representatives from Health and Human Services, and with representatives from the White House.

And then, Madam Speaker, a very interesting thing happened while we were having this series of meetings with the NIH and HHS and the White House and with the outside groups. There appeared in the literature a paper, a very interesting paper, on preimplantation genetic diagnosis. And what these medical people were doing, and this was in England, the first paper came from a clinic in England, what they were doing was going into the eight-cell stage and taking a cell or two out to do a preimplantation genetic diagnosis to see if the baby would have a genetic defect. And if there was no genetic defect, they implanted the remaining seven cells, sometimes six cells. And more than 600 times that went on to produce a perfectly normal baby. That is now being done in this country just outside Washington, in Virginia. A few weeks ago I spent probably a half hour or more on the phone with two of the medical scientists there who were involved in this research.

There is one potential ethical problem here, although the President's Council on Bioethics thinks it is not a problem. I would like to avoid, Madam Speaker, even the possibility of a problem. And that problem is that the cell that we take from that embryo might, under the right circumstances, become an embryo itself. The members of the President's, and I have the white paper here I am going to refer to in just a moment, Council on Bioethics think that that is not feasible. But, Madam Speaker, if we were to wait just a little later to take the cell to the inner cell mass, and I probably ought to put that chart of the uterus back up here so that I can point to what I am referring to here, in the laboratory they are going at the eight-cell stage and taking a cell or two out and doing a preimplantation genetic diagnosis.

If there is no genetic defect, they implant the remaining cells, and more than 1,000 times worldwide now, they have had a normal baby born. The argument is that that cell they take out under the right circumstances is pluripotent, totipotent at that stage probably, and could produce another embryo. To avoid that, if we just wait until the inner cell mass stage, which is the stage from which the embryonic stem cell lines are now developed when they destroy the embryo, there is no reason they cannot go into this inner cell mass and through the trophoblast and they could take out several cells then because there are a lot of cells there.

By that time we already have some differentiation. The cells in the inner cell mass are going to produce the baby. The three germ layers that we talked about at the very beginning and the cells in the trophoblast are going to produce the decidua. The decidua is the amnion and chorion, the tissues that support the baby, and we can see those starting to develop down here in day 8 and 9 when the embryo has attached itself to the wall of the uterus and the uterus grows and produces some tissues and there is a growth of this decidua here and we have the placenta, these big opposing vascular bags through which food and oxygen and CO2 and hormones and so forth are exchanged between the baby and the mother.

By the way, Madam Speaker, this is a pretty hazardous journey; and we do not know the exact percentage, but maybe less than half of all of the ova here that get fertilized actually implant in the uterus. As a matter of fact, one of the techniques for preventing conception is an IUD. They simply place a foreign object here in the uterus, and the uterus reacts to the presence of that foreign by not permitting the fertilized egg, the embryo, to implant there.

I yield to the gentleman from Georgia.

Madam Speaker, reclaiming my time, I thank the gentleman very much for that contribution.

While we are carrying on these discussions with the White House and NIH and HHS and with the outside groups, the President's Council on Bioethics submits a white paper; and in this white paper they go over four potential techniques that might produce pluripotent stem cells, which is another way of saying the equivalent of embryonic stem cells, without destroying or harming an embryo. And what our bill does, Madam Speaker, is simply ask NIH to please explore these potentials, first of all, in animal models; and the bill gives them $15 million to begin this exploration.

I just wanted to spend just a moment talking about the four things that are in here because it may be of interest to a number of people. The first is called pluripotent stem cells derived from organismically dead embryos. Well, this says that all these embryos I had mentioned earlier, all these embryos will not live. And when an embryo is moribund, it is not going to divide anymore, then it is the equivalent of a brain dead person and there should be no problem taking cells from it like they would take organs from a brain dead person.

One might have a little question about the vitality of the cell they take from that embryo, but at least ethically if the embryo is dead or moribund, the equivalent of a brain dead person, they could take an embryo from it. The second procedure, and the next chart shows a little clip from that, is one in which, down at the bottom here, it says ``a similar idea was proposed by Representative Roscoe Bartlett.'' This was my recommendation in 2001. And this simply says they go into an early embryo, as I have mentioned, and take out a cell without hurting the embryo because mother nature or God, whoever people think makes identical twins, has been doing this for a very long time.

Our bill simply asks the NIH to do this in animal models to make sure that it is safe and efficacious.

A third technique is called pluripotent stem cells derived from biological artifacts. This is an interesting one. And what the proposal there is that they take an ovum and they take the nucleus out of the ovum and then they take an altered nucleus out of a somatic cell.

You alter the nucleus so that you have turned off some of the genes, and then you put that nucleus inside the egg. Now, why would you do that? Because in the cytoplasm of the egg outside the nucleus of the egg, there are some factors which turn on and turn off genes and kind of control what happens inside the nucleus. So now they have turned off some genes so this thing will divide; that will never be a baby because they have kind of messed up the genetics. Well, if they can never be a baby, then maybe ethically you can take stem cells from it, and this is something that really needs to be explored.

These several techniques are all open for investigation. Oh, the fourth one of these is pluripotent stem cells by differentiation. I mentioned the differentiation of cells. That is when they decide that they are going to be just this or that, and all the cells they produce after that are just that kind of cell. Now, sometimes, you can take a cell and kind of put it in an environment where you have confused it, you have shocked it, you have done something to it, so it forgets what it was supposed to be, and it starts making cells, tissues that it would not ordinarily make in that stage of differentiation. So what our bill does is to permit the research, particularly on two of these, the nucleus transfer and the taking of cells from the early blastomere.

Our bill has received input from the White House, from the Conference of Catholic Bishops, from Right the Life communities, so there is a broad spectrum of individuals and organizations out there that are supportive of what we are doing.

In the few moments left, Madam Speaker, I would like to note that there have been a plethora of articles very recently about this, and I would like to submit these for the Record. They are not very long, and I will insert them into the Record. Here is National Geographic, July 2005. Stem cells, a big article, very good article on stem cells there. Here is a letter of May of this year from Dr. Battey who is the chief spokesman for stem cell research at the National Institutes of Health who is quite supportive of our bill and what we propose to do, and here is a very interesting op-ed piece written by Richard Doerflinger who represents the Catholic Bishops.

By the way, I need to give credit where credit is due. It was Richard Doerflinger who made the great suggestion that the first thing you do with that cell you take from the early embryo is to create a repair kit so that all during the life of that person, they will have frozen the ability to produce a new liver if they need it, islets of Langerhans, spinal cord cells, whatever they need. There is a great op-ed piece by Richard Doerflinger who explains his support for our bill. He says, Representative Bartlett and his colleagues are helping to demonstrate what has always been true: science and ethics were meant to be allies, not enemies, and this is certainly true.

Tuesday, July 12, Associated Press, Lawmakers Wary of Backup Stem Cell Bill. For those who would like to see just the Castle-DeGette bill passed, our bill, and the President, by the way, says that if that other bill gets to his desk, he will veto it. For those of us who believe that we really ought to research stem cells, we really look forward to a bill which the President can support.

Stem Cell Legislation is At Risk, July 9, Washington Post. GOP Probes Nondestructive Cell Research, Washington AP, June 29. And then just today, in Congressional Quarterly, Congress Considers Numerous Stem Cell Bills. It mentions our bill in the House, and that Bill Frist is expected to draft a related bill in the Senate.

I am very pleased, Madam Speaker, that my background has permitted me to understand some of the potential here, my experience with my grandmother, with these little diabetic kids, my profound pro-life commitment. I am very pleased that I was able to propose a potential solution that I think meets the morals and the demands of both sides of this issue.

Madam Speaker, I ask unanimous consent to insert the following articles:

Department of Health

and Human Services,

Bethesda, Maryland, May 23, 2005.

Hon. Roscoe G. Bartlett,

House of Representatives,

Washington, DC.

Dear Mr. Bartlett: I am pleased that Drs. Allen Spiegel and

Story Landis were able to meet with you, Mr. Otis and Mr.

Aitken during your visit to the National Institutes of Health

(NIH) last month to discuss ways to derive human embryonic

stem cells (hESCs). Drs. Spiegel and Landis were serving as

Acting Co-Chairs of the NIH Stem Cell Task Force during my

leave of absence from this position. Earlier this month, I

returned to chair the Task Force. NIH shares your enthusiasm

on the therapeutic potentials of hESC research and thank you

for your continued support of this field.

Drs. Spiegel and Landis briefed me about your April 26th

meeting. I am also aware that you have had previous meetings

with NIH officials, including myself, Lana Skirboll and

Richard Tasca, on this topic. You propose the possibility of

using a cell (or two) removed from the 8-cell stage human

embryo undergoing preimplantation genetic diagnosis (PGD) to:

(1) create a ``personal repair kit'' made up of cells removed

from the embryo and stored for future use; and (2) for

deriving human embryonic stem cell lines.

You suggested that creating hESC lines in this manner would

avoid ethical questions surrounding the fate of a human

embryo. Live births resulting from embryos which undergo PGD

and are subsequently implanted seem to suggest that this

procedure does not harm the embryo, however, there are some

reports that a percentage of embryos do not survive this

procedure. In addition, long-term studies would be needed to

determine whether this procedure produces subtle or later-

developing injury to children

born following PGD. Also, it is not known if the single cell

removed from the 8-cell stage human embryo has the capacity

to become an embryo if cultured in the appropriate

environment.

NIH is not aware of any published scientific data that has

confirmed the establishment of hESC lines from a single cell

removed from an 8-cell stage embryo. We are aware of the

published research of Dr. Yury Verlinsky in the Reproductive

Genetics Institute in Chicago that showed that a hESC line

can be derived by culturing a human morula-staged embryo

(Reproductive BioMedicine Online, 2004 Vo. 9, No. 6, 623-629,

Verlinsky, Strelchenko, et al). It is also worth noting,

however, that in these experiments, the entire morula was

plated and used to derive the hESC lines. The human morula is

generally composed of 10-30 cells and is the stage that

immediately precedes the formation of the blastocyst.

At the April 26th meeting, NIH agreed that such experiments

might be pursued in animals, including non-human primates.

That is, animal experiments could be conducted to determine

whether it is possible to derive hESCs from a single cell of

the 8-cell or morula stage embryo. To date, to the best of

our knowledge no such derivations have been successful. NIH

also does not know whether these experiments have been tried

and failed in animals and/or humans and, therefore, have not

been reported in the literature. NIH agreed to explore

whether there have been any attempts to use single cells from

the 8-cell or morula stage of an animal embryo to start

embryonic stem cell lines by consulting with scientists that

are currently conducting embryo research. From these

discussions, these scientists believe it is worth attempting

experiments using a single cell from an early stage embryo or

cells from a morula of a non-human primate to establish an

embryonic stem cell line.

Of note, a recent 2003 paper from Canada shows that when

single human blastomeres are cultured from early cleavage

stage embryos, before the morula stage, that there is an

increased incidence of chromosomal abnormalities. Even with

hESCs derived from the inner cell mass of the human

blastocyst, the odds of starting a hESC line from a single

cell are long, perhaps one in 20 tries. Thus, the odds of

being able to start with a single cell from an 8-celled or

morula staged embryo are equally challenging. This would make

it difficult to accomplish the goal of establishing ``repair

kits'' and hESC lines from any single PGD embryo. (Fertil

Steril, 2003 June, 79(6):1304-11, Bielanska, et al). It is

possible, however, that improvements in technologies for

deriving and culturing hESCs may improve these odds.

NIH concludes that the possibility of establishing a stem

cell line from an 8-cell or morula stage embryo can only be

determined with additional research. NIH would welcome

receiving an investigator-initiated grant application on this

topic using animal embryos. The Human Embryo Research Ban

would preclude the use of funds appropriated under the Labor/

HHS Appropriations Act for pursuing this research with human

embryos. As with all grant applications, the proposal must be

deemed meritorious for funding by peer review and then will

be awarded research funds if sufficient funds are available.

It also bears keeping in mind that it may take years to

determine the answer.

At the April 26th meeting, you had mentioned that twins can

develop when the inner cell mass splits in the blastocyst and

forms two embryos enclosed in a common trophoblast. You asked

if cells from the inner cell mass could be safely removed

without harming the embryo. In animal studies, it has been

shown that the blastocyst can be pierced to remove cells of

the inner cell mass and the embryo appears to retain its

original form but it is not known whether the embryo will

result in the birth of a healthy baby. Since this experiment

in human embryos at either the morula or the blastocyst stage

would require evaluations of not only normal birth but also

unknown long term risks to the person even into adulthood, it

would have to be considered a very high risk and ethically

questionable endeavor. Because of the risk of harm, this

research would also be ineligible for Federal funding.

You had also asked NIH about the latest stage in

development that an embryo can be artificially implanted into

the womb. We know that infertility clinics transfer embryos

at the blastocyst stage (approximately Day 5 in human embryo

development) as well as at earlier stages.

Finally, I am providing an additional resource that was

discussed at the April meeting. I have enclosed a copy of a

recently released white paper developed by the President's

Council on Bioethics (PCB) on Alternative Sources of Human

Pluripotent Stem Cells. In this white paper, the PCB raised

many ethical, scientific and practical concerns about

alternate sources for deriving human pluripotent stem cells

without harming the embryo. Your proposal is specifically

discussed in this report.

I hope this information is helpful.

Sincerely,

James F. Battey, Jr., M.D., Ph.D.,

Chairman, NIH Stem Cell Task Force and Director, National

Institute on Deafness and Other Communication Disorders.

Mr. Speaker, I was in my office last evening about 11 p.m., as was all the rest of the House of Representatives, waiting for a resolution of some of the concerns on the transportation bill so that we could vote on it, when we were looking at the ``Drudge Report'' on our screen and we saw there a headline that I could hardly believe, that Senator Frist had reversed his position on embryonic stem cells and was now advocating the passage of the Senate version of H.R. 810.

I thought it would be appropriate today, with stem cells, embryonic stem cells being so much in the news, if we could spend a few minutes looking at what stem cells are and what this is all about, what was Senator Frist talking about and what is the issue here.

I have here on the easel a chart that shows the development, not all of the stages, but it shows the development of the human embryo. It starts with the zygote. The zygote is the fertilized egg. It now has chromosomes, genes from the sperm and genes from the egg, having what we call the diploid number of chromosomes. And that develops through several stages, we will see a little later in another chart, but it goes through the blastacyst stage here and then it goes down to the gastrula stage. And by the time you get to the gastrula stage, the embryo that began as a single cell here just a few days before has now developed into a large number of cells.

What is shown here is the embryo and the part of the wall of the uterus to which it is attached. By this stage in its development, the embryo has already now developed four very specific stem cells that will go on to produce a variety of tissues and organs in the body, all of the tissues and the organs in the body, and we see those down here at the bottom.

Some of them develop into ectoderm. This is the external layer. The ectoderm becomes primarily two things in the developing baby and in the adult. It becomes the skin and the nervous system and some of the pigment cells. Most of what we are in terms of mass is all developed from the middle layer, or the mesoderm, and from that develops all of your skeletal muscle, all of your skeleton, all of your bones, all of your heart muscle, the red blood cells, the smooth muscle in your intestines and stomach and so forth.

Then a third stem cell here ultimately develops into the entoderm. And here we see that this is the lining of the lung, the thyroid gland, and pancreatic cells, nowhere near the mass that is produced by the mesoderm, but very important tissues nevertheless.

Then there are some very unique cells. They are different in the male and the female. They are the germ cells. In the male they produce the sperm and in the female they produce the egg. Some of these stem cells persist even into the adult. In the bone marrow of every adult are stem cells which will produce erythrocytes, your red blood cells, which produce some of your white blood cells. The polymorphonuclear leukocytes will produce those cells that help in clotting, the thrombocytes.

And there are stem cells in other adult tissues. And there has been a lot of research for more than three decades now on using these stem cells to see if we cannot cure or help patients with a number of different diseases. And there have been a number of good applications of adult stem cells. They have produced betterment in a number of individuals, in some cases what looks like actual cures.

But these adult stem cells are limited in their capability because they are already what we call differentiated. They have already split, and a number of the genes have been turned off, and they now are destined to produce only a certain kinds of cells. What the researcher tries to do at times is to take these adult stem cells and put them in an environment that convinces them that they are not really an adult stem cell, but that they have gone now back to a more primordial state, that they are back to an embryonic stem cell.

Here in the blastula we see embryonic stem cells. Of course, the ultimate embryonic stem cell is the zygote: one cell, which will divide again and again and again, and then differentiate, and then finally produce all of the cells of the body. But here in the blastula stage we have the cells already differentiated into two different categories: those cells which are going to produce the embryo, and they are shown here in this inner cell mass; and then those cells which will produce the dissidua. And the dissidua is the cells around this which will become amnion and corion parts of the placenta. In the stage just before this are the cells that can produce the full embryo.

I would like now to look at our next chart here because this shows the development of the embryo, and it has all of the stages there. It starts with the zygote. Here we have the fertilized egg, or the zygote. Of course, this all begins with an ovary. This is only half of the reproductive system of the female. An ovary which every month routinely during the childbearing years will produce an ovum. Here it shows the follicle rupturing and the ovum coming out. Here is the oocyte. And then here are the sperm, and the sperm of course make their way all up through the uterus and the fallopian tube, clear up here to the end of the fallopian tube.

And by the way, they actually sometimes get out into the abdominal cavity. Sometimes this egg is not picked up by this little funnel- shaped end, and you see part of the funnel here, called the infundibulum. Sometimes that cell does not get out there, and it does not get picked up by the fallopian tube and carried down with the beating of a number of cilia and it goes out into the body cavity. And the sperm may actually get out there too, and it can be fertilized there. We call that an ectopic pregnancy. And of course the baby cannot develop there and it is going to die, and it is going to cause a lot of problems for the mother. So this ectopic pregnancy has to be terminated because it will cause the death of the mother if it continues.

After the fertilization, the egg begins its journey, taking several days, maybe as many as 8, 9, 10 days before it finally reaches the end of the journey and is implanted in the wall of the uterus. It divides first two cells, then four cells, and then eight cells. And I would like to pause for just a moment at that eight-cell stage. Imagine now that we are not in the reproductive tract of the female, but we are in a petri dish in the laboratory, because that is what in vitro fertilization means. In vitro means in glass. And they are now taking the egg from the mother and sperm from the father and they have combined these two and produced this fertilized egg, the zygote. It now divides and divides until they come to the eight-cell stage.

At this stage, more than a thousand times worldwide, in one clinic in England more than 600 times, they have taken in the laboratory under the microscope a cell, and sometimes they get two from that eight-cell stage, and they have done what they call a preimplantation genetic diagnosis. They look at the genes, and you can do that, we now know what they ought to look like, and they can determine if there is any genetic defect.

One of those genetic defects is what we call trisomy 21, mongolism. If there is an extra chromosome at the 21st chromosome, you get what we call trisomy 21, or mongolism. If there is no genetic defect in the cell that they analyze, which would be like all the other cells because they began as a single cell here, then they implant what is remaining, that is the six or seven cells that is remaining, and now more than a thousand times worldwide we have had what looks like a perfectly normal baby born from this process.

This technique, which has been widely used in England, is now used in this country; and just outside Washington, here in Virginia, is a clinic that is doing this. They have done it more than 300 times now. Several weeks ago, I talked for perhaps a half-hour with two of their doctors about the procedure.

Let us now take a look at how they get embryonic stem cell lines. They take an embryo in the laboratory which had been produced by the fertilization of an egg, and they let it develop, not to the eight-cell stage, they go just a little beyond that. They go to the inner cell mass, and then they destroy the embryo. And there are now a lot of cells, not just eight; and they take a number of the cells from the inner cell mass, which I indicated previously had all of the genetic potential to produce the body of the baby, but none of the genetic potential to produce the dissidua. And so here we see right at the bottom of this chart we see the dissidua developing there, the little fingers like that are growing into the lining of the uterus.

Well, what this debate is all about, Mr. Speaker, is about the morality, really, the ethics of taking this little embryo, which is a baby in miniature, because, you see, if it goes on just a couple of days later and implants in the uterus, it will become a baby, although it is now in the petri dish in the laboratory, but it can be implanted in the uterus, to take this embryo and to destroy it and take the cells from the inner cell mass to produce a stem cell line. Up to this time that has been the only technique that has been available for developing these stem cell lines.

The President had a very difficult decision to make 4 years ago when there was an interest in using Federal monies to fund further embryonic stem cell research. Maybe we ought to pause for a moment, Mr. Speaker, to look at why we are so much interested in stem cell research. Because these stem cells, as the earlier chart showed, can produce all of the tissues in the body, there is the hope, the promise, and in fact even the realization with some of the work we have done with adult stem cells that we can use these stem cells to replace tissues which have been damaged by disease or some other trauma in the body. We can replace those so as to restore health.

Now, we have a lot of applications from adult stem cells and, as we stand here today, essentially no applications from embryonic stem cells. And why should we have this big debate, Mr. Speaker, about embryonic stem cells when almost all of the applications to medicine have been from adult stem cells? You see, we have been working with adult stem cells for more than three decades, so we have had a lot of opportunity in the medical community to make applications there, but we have been working with embryonic stem cells for only about 6 years, and there just has not been the opportunity to make the medical applications from embryonic stem cells that we have been able to make from adult stem cells.

But because of what embryonic stem cells are, because embryonic stem cells still have all of the capability to produce any and every tissue in the body, doctors and researchers believe intuitively from what they know of embryology that there ought ultimately to be more and better applications from embryonic stem cells than there are from adult stem cells. We do

not know. It may be that these embryonic stem cells are going to be like unruly teenagers, very difficult to control. You see, their destiny in life is to divide and divide and divide.

We want them to do that, but we want to be able to control how they divide and what they produce, because if it is a liver the patient needs, you need to convince the cells that is what they ought to be producing, and when they have done enough, they need to quit. They may be very difficult to control. They may keep on dividing, and when you put them in the body, they may form tumors.

Because of what embryonic stem cells do, the medical community and indeed millions of Americans with relatives with devastating diseases believe there are important applications from embryonic stem cells to medicines. We need to provide that opportunity without harming the embryo.

To this date the only way we have gotten these embryonic stem cell lines started is by taking some of the cells from the inner cell mass, which destroys the embryo. In 2001, the President was faced with a very difficult decision. He needed to determine whether Federal funds could be used in embryonic stem cell research when the only way to get embryos at that time was to destroy the embryo.

When the President was making that difficult decision, the scientists at NIH had an open house for Members of Congress and staff to come to NIH and learn about embryonic stem cell research and the potential. I went there, Mr. Speaker, and listened to their presentations. Because in a former life I was privileged to be able to get a Ph.D., a doctor's degree in human physiology, because I taught medical school, because I had a course in advanced embryology, I knew a little bit about what they were talking about.

As I sat there listening to the researchers at NIH explaining what they were doing and the dreams and the hopes that they had for the applications of embryonic stem cell research, and when I thought about the dilemma that the President was in in trying to decide whether it was okay to destroy these embryos to get a stem cell line that may come up with some miraculous cures, I thought back to my studies and to a course that I had in advanced embryology. And really you do not need to have had that course to understand this, but it occurred to me nature had been doing for a very long time what we needed to do, and that is to take cells from the early embryo without hurting the embryo. Nature had been doing that by producing identical twins. In identical twins, half of the cells are taken away from the embryo, and each half goes on to produce a perfectly normal baby. And one of those identical twins is a clone. Think about that and decide how that relates to the dialogue that we are having on cloning.

Well, there are two different times during the development of the embryo, maybe more, but at least two different times that it can split to produce identical twins. One is at the two-cell stage. Instead of just dividing to make four cells, it splits, so there are now two one- cell embryos, and each one goes on to divide and produce a baby. Or it can wait until the inner cell mass stage, and in some embryos there are two inner cell masses, and that can now split to form identical twins.

Sometimes this is not perfect, and they do not split totally, and we have what we call Siamese twins. This is the origin when the split has occurred probably at the inner cell mass stage, and it is not complete, and they remain close enough that some parts of the body grow together.

We know that the embryo is capable of splitting at these two different stages because of the way the babies present themselves at birth. If they are both within the same amniotic sac, they probably split at the two-cell stage. If each have their own amniotic sac, they probably split later.

It occurred to me since nature many times takes half of the cells away from the early embryo and they go on to produce two perfectly normal babies, we ought to be able to take a cell or two from an early embryo without hurting the early embryo. And I asked the scientists at NIH, should we not be able to do it? They said we ought to be able to do it, although we have not done it.

A little after that I was at an event when the President was there, and I mentioned this possibility to the President. He asked Karl Rove to follow up on it, and a few days later I got a call from Karl Rove saying he had talked to the NIH; the NIH told him what I was proposing was not doable.

I said Karl, either they did not understand your question, or there is some confusion, because these are the same people that can take a single cell and take the nucleus out of that cell and put another in it. Of course they can do this. He went back and asked them again, and he came back and said he got the same answer, that they could not do this, and so the President came down with his executive order.

A couple of years after that, not very many months ago, the people from NIH were sitting in my office, and I asked them how could this have happened. What apparently happened as so often happens, there was a miscom- munication. What they told Karl Rove was they were not sure they could produce an embryonic stem cell line from an embryo that early because they had never done it, not that it was not doable. He interpreted this as saying they could not take the cell, and, therefore, the research could not be done.

I would like to spend just a moment looking at some of the reasons why people are so concerned and why this was such an important decision on the part of the President, and why Senator Frist's decision last night has stirred up so much controversy. It is because there are a very large number of diseases that have the potential of being cured ultimately with the application of embryonic stem cell research.

Let me give us one example, and that is diabetes. Kids come in my office with this hockey puck-like thing under their skin, which is an insulin pump. They have to prick their skin to get a glucose level so they can set the pump, and they are very brittle. It has to be pumped in regularly. This is the most expensive disease in our country, and it is potentially totally curable with stem cell applications. All we need to do is produce some islets of Langerhans cells because these are the cells that just happen to be embedded in the pancreas. There is no reason why they need to be in the pancreas. They have nothing to do with the function of the pancreas, because the pancreas is a big digestive gland at the beginning of the small intestine that produces enzymes that digest fats, carbohydrates and proteins. Embedded in the tissue of the gland are what looked like these little islands to Dr. Langerhans, and so we call them the islets of Langerhans. They produce insulin.

Now, insulin does not cure diabetes, as any family who has diabetes in the family knows; it simply delays the course of the disease. There may ultimately be some problems with the eyes and circulation. You lose some toes, they have to be amputated. If we could create islets of Langerhans cells, which could be under the skin anywhere in the body, anywhere that the blood can get to them so the circulation can pick up the hormone that is produced, this should cure the disease.

And there are many others, particularly the autoimmune diseases, and there are 63 autoimmune diseases. These are diseases where the body gets confused what is really body. There is something very interesting that happens with early embryos. Obviously we need to know what is us so foreign things can be rejected. When you get inside your body, there are no bacteria in there. That is a pristine world. We have a big army of white cells in there that make sure that it is pristine. The white cells are told by what we call T-cells as to what is you and what is not you, so they attack what is not you. Sometimes, and in more people than we would like to have it occur in, sometimes the body gets confused as to what is really you.

I have a little problem, rheumatoid arthritis, which is an autoimmune disease. The body starts attacking itself; and there are 63 of them, and potentially all of them could be addressed with embryonic stem cell research.

Alzheimer's disease, a very tragic disease. Central nerve injury, an injury to the spinal cord, those cells do not grow back. There is a potential you could put new cells in the spinal cord, and people in a wheelchair could walk

again. There is that potential, and that is why embryonic stem cell research is of such great interest, because of the enormous potential that they ought to have because they are so totally undifferentiated because they can produce any and every cell in the body.

I have been working with the White House, with the National Institutes of Health, with the Conference of Catholic Bishops, and with the prolife community in developing a bill, H.R. 3144, which would permit research on not just the procedure that I recommended more than 4 years ago now, but several other procedures that are outlined in a little book here called Alternative Sources of Human Pluripotent Stem Cells, A White Paper, produced by the President's Council on Bioethics, and they talk about four different kinds of research, four different ways of procuring embryonic stem cells that might be ethically acceptable to the prolife community.

The first of these is pluripotent. By pluripotent, they mean cells that have the capability of producing all of the tissues of the embryo, but not the decidua. That is a totipotent cell. Pluripotent stem cells are derived from embryos that are essentially moribund, dead; the equivalent, if you will, of an adult that is brain dead.

It is perfectly ethical, most people believe, to take organs, that is how we get organs for transplant from adults that are brain dead, so if you now have an embryo which is obviously not going to develop, but it still is alive enough that you might take cells from it to produce a stem cell line, if you really knew that it was dead and could never produce a baby, then ethically it would appear to many people to be okay to take cells from that to establish a stem cell line. You might have a little concern that an embryo that had sat there a day or two and never divided because there was something wrong with it, that the cell you took from it to produce a stem cell line might not produce just the high-quality stem cell line that you might like for research, but at least it is worth exploring, and it gets by the ethical arguments.

The second one of their proposals, and I would like to look at the next chart now as we do that. Let me just look at this chart for a moment here with you. This comes from a white paper on the President's Council on Bioethics. Let me look at the highlighted portion: ``It may be some time before stem cells can be reliably derived from single cells extracted from early embryos.'' That is the procedure that I was talking about that occurred to me when I was out at NIH talking to the investigators there. ``And in ways that do no harm to the embryo, thus biopsied. But the initial success of the Verlinsky's Group's efforts at least raises the future possibility''--Verlinsky is a Russian scientist working in this country who says that he has done what NIH said they were not sure they could do, and that is to produce an embryonic stem cell line from one cell taken from an early embryo--``at least raises the future possibility that pluripotent stem cells could be derived from single blastomeres.'' A mere is a cell, and it is taken from the blastula so it is a cell taken from the blastula. A blastomere. ``Removed from early human embryos without apparently harming them.''

And then the asterisk there. If you look down at the bottom of the page, it says, ``A similar idea was proposed by Representative Roscoe Bartlett of Maryland as far back as 2001.'' What they are referring to is the recommendation that I made to the President that he relayed on to Karl Rove. This is recognized in this fairly recently published white paper, Alternative Sources of Human Pluripotent Stem Cells, a white paper by the President's Council on Bioethics. This is one of four different procedures. The first, you remember, was taking cells from an embryo that is essentially moribund, it is going to die, and like the person who is brain dead, why not get some benefit from it. We do that with organ transplants all the time.

The third one is very interesting, and that is to produce pluripotent stem cells derived from biological artifacts. There are two artifacts that they are looking at to do this. One of those goes back to this little embryo in the petri dish that we talked about. What they want to do is go in that early embryo and turn off some of the genes. We know how to do this. To turn off some of the genes so that it can never produce a baby, but could go on dividing and produce a mass of cells. They call this an artifact. If it is not going to be a baby, it is just this mass of cells growing, maybe it is okay to take cells from it to produce an embryonic stem cell line.

But some people might have a little concern, Mr. Speaker, that you have gone in early and messed up what could have become a perfectly normal baby, you have turned off some of the genes so it cannot, so now you have created kind of a freak that you can take some cells from, and since it is not going to be a baby, it is okay to take the cells from that. But at least it is a way of getting embryonic stem cells without destroying what at that moment is perfectly normal stem cells.

There is another possibility, and that is parthenogenesis. That is the development without the union of sex cells. The fourth technique is an interesting one and that we are trying to do all the time. That is to take what is called the pluripotent stem cells via somatic cell dedifferentiation. A somatic cell simply means a body cell. The soma is the body. Take a body cell from anywhere in the body, skin, muscle, lungs, anywhere, and dedifferentiate it, try to produce this cell in an environment that it is confused as to what it is, that it kind of thinks and behaves like it is an embryonic stem cell. If we can do this, that is great, because ethically there should not be any problem doing this. But this has not been done. There are big technical challenges to doing this.

Now, this white paper gives a very good discussion of the proposal that we made; that is, of getting cells via blastomere extraction, sometimes called biopsy. You are going in and just taking out a cell or two. They even talk about producing the repair kit, which would be really advantageous to the baby through all of its life now. If it needed a new liver, new islet of Langerhans cells, if it needed new spinal cord cells, hopefully in the future we would be able to produce those from this repair kit.

But when they get back for some strange reason, Mr. Speaker, it almost looks to me like two different groups wrote the body of this text where they talk about this technique and where they make the recommendations, because in the recommendations they say the second proposal, blastomere extraction from living embryos, we find this proposal to be ethically unacceptable in humans. Owing to the reasons given in the ethical analysis, we should not impose risks on living embryos destined to become children for the sake of getting stem cells for research.

I agree. That is not the reason the stem cells are taken from this baby. As a matter of fact, if the cells are taken with no thought that they are stem cells, the cells will be taken by the parents to produce a repair kit or to do a preimplantation genetic diagnosis for the baby, and I think that most Americans do not have an ethical problem, Mr. Speaker, with in vitro fertilization. I think that most Americans do not have an ethical problem with deciding that your baby is not going to have a genetic defect. I do not think that hardly any Americans could ever have a problem with establishing a repair kit for your baby.

What is envisioned is that at the end of the day, the parents would have made at least two ethical decisions, what I consider ethical and I think what most people consider ethical; that is, to have their own baby, the only way they can do it is in vitro, and to establish a repair kit for their baby, and then all that needs to be done to get another stem cell line is to ask them, Couldn't we have some surplus cells from the repair kit that you have established.

There is a big discussion going on in our country now, Mr. Speaker, about embryonic stem cells. They voted how many billions of dollars in California to pursue embryonic stem cell research because a big percent of our population believes that there could be a major medical application there which would provide miraculous cures for many of our diseases. And then we have a large number of people, the prolife community, that have a big problem with taking these embryos, any one of which

could become a baby, we have more than 100 of them, is what we call the snowflake babies that have been adopted, implanted in the receptive womb of a mother, and they become a baby; to take this human life, and it is a life, and it is human, and destroy it so that you can produce a stem cell line.

Most of this debate ignores the fact simply because the debaters do not know that it is possible, Mr. Speaker, to get embryonic stem cell lines without harming embryos.

I would like to go back again to the second chart I showed, which is the path of the reproductive tract of a female, so that we can look at this again together so that we understand clearly what we are talking about here. We will imagine now that this is happening in the laboratory and it is in a petri dish, in glass. In vitro is what we call it. Because the parents could not have a baby any other way, they decided to have in vitro fertilization, and they decided they would like to at least do one thing, and that is to establish a repair kit for their baby. They might also want to do a preimplantation genetic diagnosis.

So now the physician in the clinic will wait until the cells divide and produce several embryos. By the way, they do not all produce really good-looking embryos, and so what they do is to fertilize more than one egg, and they then watch the development of these embryos, and they will take the best of them and generally more than one of them.

One of my colleagues, Congressman Rohrabacher from California, his wife had three beautiful babies from in vitro fertilization. I do not know how many the doctor implanted, but at least three of those that he implanted grew, and she had triplets. I saw a recent picture of them in their little life vests out in the surf in California.

There is a potential ethical argument in doing this even if we let the parents make the decision they are going to do the in vitro fertilization, if the parents make the decision that they are going to establish a repair kit, and then all we ask for is a few cells from that repair kit. You see, if the cell is taken from the eight-cell stage, then you could make the argument that maybe the cell you took could become another embryo. So then you start all over again with the ethical argument. You now have another embryo. And so you now ethically should not destroy that embryo with the hope that you are going to have some applications to health care for somebody else.

There is, Mr. Speaker, one way to avoid this, and it is one of the things that our research, H.R. 3144, would pursue, and that is waiting a little later to take this cell. I am not sure for all the reasons that they take the cell at the eight-cell stage, but that is the convention. If you waited to take that cell from the inner cell mass stage, which is a little later, a few days later, then the differentiation has already occurred to the point that the cells in the inner cell mass which can produce the whole baby, but they cannot produce a baby by implantation because they have lost the ability to produce decidua. So you have now removed that possible ethical argument, although those who wrote the white paper on the Alternative Sources of Human Pluripotent Stem Cells do not believe that you could do this. But if there is any possibility that you could do that, then for those whose sensitivities would be offended by this, if we could demonstrate that you could take it from the inner cell mass stage, now you have bypassed even that.

Our bill, H.R. 3144, is a bill that looks for the moment only at animal experimentation, because we believe that before you go to humans, you ought to know that what you are doing is going to work and that it has worked. The best way to do that is to go to animals and ultimately to what we call nonhuman primates; that is, the big apes which genetically, by the way, are remarkably close to humans. It may be embarrassing, Mr. Speaker, to look at the genetic complement of one of the great apes and look at our genetic complement. There is not all that much difference in us. Once we have demonstrated it there, then we could have more certainty that it is going to work in humans.

What we do not need, Mr. Speaker, is for millions of Americans to feel that their last best hope for a cure for their relative had been removed when the President vetoes H.R. 810 and its Senate complement, which he has said he would do, which I hope he does. I think it is the ethical thing to do.

What we need, Mr. Speaker, is to have this bill on the President's desk so that those millions of people out there who believe that there is potentially a lot of applications in health care from embryonic stem cells will know that the Federal Government believes with them that this is possible; that we are going to support responsible, ethical research, using cells taken from early embryos that certainly do not kill the embryo, do not harm the embryo. As a matter of fact, if, Mr. Speaker, we get those cells, the surplus cells from the repair kit, then the parents have made two decisions which I think, and I believe most Americans will believe, are ethical, one, to have their own baby, the only way to do it is in vitro; secondly, to establish a repair kit so that at any time during its life, their child is going to have the potential for new tissues, new organs, new cells that is going to be them, so there will be no rejection.

Mr. Speaker, what we saw last night I hope results in a very positive eventuality. I hope that by the time H.R. 810 and its Senate complement gets to the President's desk, that also on his desk is H.R. 3144, so that the President can say, today I proudly sign a bill which provides for research which has the potential of producing embryonic stem cells for all the miraculous applications to health care that citizens all across the country believe. Because in State after State now they are voting in referenda to provide, sometimes in the legislature, sometimes just a vote of all the people, to provide very large amounts of money statewide because the Federal Government is not doing it, and they believe there is a big potential there.

I hope that in the not-too-distant future, Mr. Speaker, that we will be using Federal funds to support responsible, ethical embryonic stem cell research, and H.R. 3144 will do it.

I certainly thank the gentleman from Maryland for yielding. It is indeed a pleasure to again be with him tonight, Madam Speaker. Any opportunity that I have as an original cosponsor of the gentleman from Maryland's legislation, H.R. 3144, is an opportunity that I gladly accept no matter what the hour. The importance of this issue really cannot be overstated.

I know the gentleman from Maryland as he started this Special Order hour discussed the fact that of the so-called throwaway embryos, throwaway babies as we see it in these in vitro fertilization clinics that exist across this country, I think somebody estimated there were 400,000 of them and that in some instances couples who had gone through in vitro fertilization and completed their families truly would have some extra embryos that they at least at a certain point in time had no intention of having reimplanted. So for the time being, maybe they were excess embryos.

But those of us who feel very strongly about the sanctity of life truly believe that there is no such thing as an excess human life at either extreme, the very youngest embryonic stage or the very oldest, many of whom I would be referring to, our octogenarians and older who might be in a nursing home suffering from Alzheimer's disease at the final stages of their lives, but all of these lives are extremely important; and as the gentleman from Maryland pointed out, there are actually 100 or close to 100 little babies, up to 6, 8 months old now who were referred to as the snowflake babies. They actually were donated to couples who were barren, infertile, from these couples who had completed their family and had these excess embryos frozen that they were not going to use.

We have seen them. I think the gentleman from Maryland (Mr. Bartlett) had a lot to do with bringing, along with the gentleman from Pennsylvania (Mr. Pitts), these little children to the House, to the Congress, and indeed to the White House during the week that we were debating the bill brought to us by the gentleman from Delaware (Mr. Castle) and the gentlewoman from Colorado (Ms. DeGette).

As the gentleman from Maryland points out, there are a lot more of those little lives that are still on ice, if you will; and the gentleman from Maryland is so right in pointing out that, hey, maybe one of those would be an Einstein one of these days, the next Einstein. Some of my colleagues say, well, just 100 out of 400,000, that is not very many. Indeed, it is a fourth of this body, Madam Speaker, almost a fourth of 435 Members of the House of Representatives. There may be some real smart ones remaining on ice that possibly could end up being United States Senators. More importantly, of course, it could be the next Pope John II or Pope John III or Martin Luther King, Jr. or Abraham Lincoln. Who is to say what we are talking about as a throwaway life? I am just so grateful for the gentleman from Maryland for bringing us a bill, H.R. 3144, which avoids this issue of destroying human life for the purpose of obtaining embryonic stem cells.

I do not think, Madam Speaker, that we will ever get to the point in this Chamber, as much as I, and I am sure the gentleman from Maryland is of the same mind-set, of wanting to do things in a bipartisan fashion with our colleagues on both sides of the aisle, this issue, this pro-life/pro-choice issue. The country is probably pretty evenly divided. This body is probably evenly divided.

But the point is we do not have to get into a knockdown, drag-out, hair-pulling, fingernail-scratching bloodbath over this issue. That is what the gentleman from Maryland is bringing to us, an opportunity to support a bill that does not lead us down that road where there seems like there will never be a meeting of the minds. This opportunity, basically, as he is pointing out with his posters in regard to the ability, with some research, to be able to obtain embryonic stem cells without destroying human life, without destroying the embryo, I have heard him refer to this almost like an embryonic biopsy.

As I understand the bill, it is an opportunity to encourage, with the President's blessing, increased funding through the NIH for research on nonhuman primates to make sure that this biopsy, actually it has already been done in genetic counseling studies on couples who have a really strong family history of inheritable diseases, something like hemophilia or Duchenne's muscular dystrophy where maybe if it is an adult child, it has a 50 percent chance of having one of these life- threatening, eventually fatal diseases. We are already doing testing on those embryos to make sure that it would be safe to put them back into the mother's womb to grow and develop and become a full-term fetus and there has been no harm in those instances.

This is not wild-eyed science, something that is Star Wars mentality. Not at all. We are talking about one of the brightest Members of this body, a Ph.D. physiologist, a doctor of physiology who has taught in medical school.

Madam Speaker, when I was in medical school, it was my instructor who taught me physiology, the functioning of the human body in a healthy situation, whether we are talking about the heart, the lungs, or any organ system of the body. That is the study of physiology. That is who we are talking about when we reference this Member, the gentleman from Maryland, who is bringing us this bill. He knows of what he speaks. He has taught not only physiology but also embryology.

I know my colleagues as they listen to his presentation tonight and they look at the material, the visual aides that he has with him, it is clear that his understanding, his depth of knowledge is far beyond maybe what even the physician Members of this body have. So it is with a deep amount of respect for him that I have signed on to this bill. I am fully supportive of it. It gives us an opportunity to address this issue of trying to find a way with stem cells, whether they are adult or embryonic; and I tend to agree with the gentleman from Maryland that embryonic stem cells probably do have a little more potential, although we have had great success in adult stem cells and a lot of these diseases that our colleagues have talked about and we have seen public service advertisements, famous people, actors, former politicians, a former first lady, families of those suffering from diabetes, spinal cord injury, degenerative disease, Parkinsonism, Alzheimer's. These things really tear at your heartstrings.

There is no argument, I do not think, in this body, in a partisan way about wanting to help and wanting to use science to the best of our ability to look for a cure. There is not a guarantee. There is absolutely no guarantee. There are probably lots of complications, false starts, two steps back for one step forward. There will be lots of money, Federal dollars probably being spent on research. But the point is the President in August of 2001 was absolutely right, in my humble opinion, in regard to his decision to put a moratorium on the harvesting of stem cells, embryonic stem cells that would result in the destruction of human life. At that point, there were some 60 cell lines already in existence that our university research scientists at NIH and other places were using. The President said, that is perfectly okay to continue.

Those lives have already been destroyed in obtaining those stem cell lines. Good research was occurring. The President, this President, George W. Bush, is the very first President that, in fact, allowed Federal funding for research on embryonic stem cells. So those who criticize or suggest, Madam Speaker, that this President is insensitive and uncaring, I suggest to my colleagues that this President is the most caring that we have ever had in regard to this issue. He has done more than any other President. He does not deserve to be criticized, but rather applauded for his efforts in this regard.

And I think he is steadfast in his determination not to destroy human life because, as the gentleman from Maryland has pointed out and as I just said, we do not know those so-called extra embryos, those throwaway embryos. We do not know what those lives entail. We do know that they have a very unique, full complement of DNA that have all of their genetic material they are going to ever have. They are the

tiniest of human life, little tiny babies. We call them embryos, but they are little tiny embryos whose lives are frozen and suspended. But they should have that opportunity.

And even the couples who think, Madam Speaker, that they would never use those embryos, we have witnessed tragedies every day in the news, this 24-hour cable news that we are subjected to, but we read about children that are kidnapped, abused, murdered, the situation in Aruba, the situation in Nebraska. We can just name so many where people think that their family is complete and they have got all they want out of their reproductive life, and all of a sudden, as the old country song goes, ``some days are diamonds and some days are stones,'' all of a sudden we have a few days that are stones and there might be a tragic loss of a child or more than one child, and all of a sudden maybe those frozen embryos do not seem so expendable anymore.

So that is why this issue is so important and why I feel so very passionate, not just myself and the author of this bill, the gentleman from Maryland (Mr. Bartlett), but a number of others who have signed on to this bill. The White House, I think, is very supportive of this. There is a companion piece of legislation, as I understand; it originating in the other body. We are on to something here.

And again it is a pleasure to join my colleague tonight and share these thoughts, try to maybe enlighten my colleagues on both sides of the aisle, Madam Speaker; and I do thank the gentleman for giving me an opportunity to be with him to discuss such an important issue. And I will be glad to stick around for a little while if we want to get into a colloquy later on, but I thank him for giving me this opportunity.

Madam Speaker, will the gentleman yield?

Madam Speaker, I wanted to mention to the gentleman that as an OB/GYN physician, of course I have had some experience with some of the processes that can occur in reproductive endocrine laboratories and the technique dealing with infertile couples, and I have had a discussion with the gentleman from Maryland about this. But in a situation where the couple is infertile and it is because of male infertility, there is nothing wrong with the egg, but there is a very, very low sperm count in the male, and normally it takes probably 1,000 sperm to successfully fertilize an egg in the natural way.

In fact, the normal sperm count in a male is about 60 million. But even a sperm count as low as 1,000, pregnancy can occur in the normal, natural way. But when it gets much lower than that, it becomes less and less possible. But they have a technique. And there is an acronym, Madam Speaker. There is an acronym for everything, it seems, even though this is not in the military. That acronym is ICSI. It stands for intracytoplasmic sperm injection, ICSI. And these biologists working with reproductive endocrinologists, medical doctors who specialize in infertility, can literally take a single sperm and with a needle inject that sperm into the egg and create a life, and that has been done many times, and not just at the NIH, but in a lot of these infertility clinics across this great country, in my State of Georgia. It is something that is done routinely.

So what the gentleman from Maryland (Mr. Bartlett) is talking about

in this poster presentation in regard to waiting to just the right point for these scientists to be able to develop a technique to obtain embryonic stem cells without destroying that embryo and beyond the point where that single cell itself would be an embryo, he knows of what he speaks. And I wanted to have an opportunity to share that, Madam Speaker, with our colleagues and make sure they understand that here again we are not talking about Star Wars technology here. We are talking about things that are being done today.

Well, first of all, let me thank the gentleman from Maryland for his legislation, H.R. 3144, and for allowing me to spend a little time with him this evening as we try to explain to our colleagues what we are talking about here and what is the essence of the Bartlett bill.

I think the gentleman is correct that the perception among those of us who are strongly pro-life, and I think most of my colleagues on both sides of the aisle sort of know each other's former profession before we came to this august body, and I practiced medicine, not just an M.D., but specializing in obstetrics and gynecology; and so over a 26- year period, doing the average number of deliveries a doctor would do in a year, that amounts to over 5,000; and very proudly I can stand here tonight and say that I am pro-life and have never performed an abortion.

But I think that in response to the gentleman's question, people that are pro-life know that embryonic stem cell research that was ongoing before President Bush made his decision 2 or 3 years ago, that those stem cell lines were indeed obtained from this so-called excess. Really not excess. Cannot tell that to the Snowflake babies that have been adopted, those embryos, and there are close to 100 of those precious children alive today, but the pro-life community, indeed, everybody understood that the stem cell lines that were created were created from the destruction of embryos that were produced utilizing artificial reproductive technology that the gentleman from Maryland so adequately explained.

And of course those children, and I say children, they are embryos, but they certainly become children. They become fetuses, and they become children, and they become young adults, and they become middle- aged and senior citizens. They are human life. And, basically, what the President said is those that have already been destroyed to create these cell lines, we will allow researchers, our scientists, to apply for grants to conduct the research on those cell lines, those embryonic stem cells, but not to destroy any more life; to put a moratorium on that and to absolutely not continue to destroy life.

In fact, in 1999, President Clinton's National Bioethics Advisory Commission, NBAC, acknowledged broad agreement in our society that early human embryos ``deserve respect as a form of human life.'' They recommended funding of embryonic stem cell research only if there were no alternatives. But what Congressman Bartlett is talking about tonight, of course, is an alternative, a viable, if I can use that term, a viable alternative. And that is what he has outlined for us in this legislation, and I know he will talk about that.

But the important point is that people who are pro-life understand this, that taking a cell or two from an embryo, once it has gotten to the point where those cells are not totipotent, that you are not literally taking maybe something that in itself could divide and become an embryo; you get beyond that stage to what he describes as pluripotent.

And the difference in those two capabilities in those embryonic cells is hugely important to the pro-life community. And he, of course, has done such a great job tonight, and I commend him for that, of explaining how in nature this occurs with the division of a multi-cell embryo to become identical twins; and it is, I think, a good explanation. And I think that is probably what is important, in response to your question, my good friend from Maryland, is this educational process.

And I know you have worked on this. I do not know how many times you have done this Special Order, but you have honored me in giving me an opportunity to participate with you and get into a colloquy and discuss some of these issues. This is the way to do it. This is the seed corn. This is what gets it started. It is a matter of understanding that there is an alternative to destruction of human life for the betterment of other lives.

Mr. Speaker, if the gentleman will yield, I think it really is a good point that you are making that we have been utilizing adult stem cells for a long time, for many years, and whether we are talking about cells that are obtained from bone marrow or from blood, even, of course, some umbilical cells. But as the gentleman points out, there have been some real great success stories reported: cancers, including ovarian and testicular cancer; leukemia; Hodgkin's disease; stroke; heart disease; Parkinson's disease; as the gentleman mentioned, juvenile diabetes; Crohn's disease, an inflammatory disease of the bowel which can be so devastating.

And I think Roscoe Bartlett, the gentleman from Maryland, mentioned maybe 58, in total, success stories. But the earliest cell, I think, has the greatest potential, and that is basically the point that the congressman is making and why his bill, H.R. 3144, to provide funding, very necessary funding, to do the basic and applied research starting in animal models to show that you indeed can take these, again, not totipotential but pluripotential, so not another embryo, but something that has gone beyond that stage that does not have the capability in and of itself of becoming a human being. That is what we want to say to the pro-life community.

So we are taking, though, the very earliest beyond that stage cell, and there is no telling what tissue it can develop into, whether we are talking about brain tissue and trying to treat people, God rest his soul, like Christopher Reeves or other people with spinal cord injuries, or someone with severe Parkinson's disease or Alzheimer's or juvenile diabetes where you create islet cells that you can transplant into a person's pancreas that, because of a genetic defect, has no islet cells.

So that is really, I think, the answer, to say why it is worth the effort, why it is absolutely worth the effort. First and foremost, you do not have to take human life for the betterment of other human lives, and we want to build on the success of utilization of adult stem cells and go that extra mile, and this is what this bill will do, allow us to do the basic research, fund it with Federal dollars so we can get to that point.