Stem Cell Research Enhancement Act of 2005

Mr. Speaker, we have just heard an impassioned plea to proceed with embryonic stem cell research. Tomorrow we are going to vote on a bill that would expedite embryonic stem cell research. I have here the latest issue of Time magazine. It just arrived in our office, May 23, and the lead article in it says ``Why Bush's Ban Could Be Reversed.'' It is talking about stem cell research.

In view of the interest all across America and in view of the fact that tomorrow we are going to be voting on a bill, I thought it might be well this evening to spend a few minutes putting this debate in context.

What are stem cells? This is a new term to many Americans. Our first chart is a depiction of the development of early embryos and then all of the tissues in the body which develop from this embryo.

The ultimate stem cell here is the zygote itself. The zygote is produced by the union of the egg from the mother and the sperm from the father. A stem cell is a cell which has the capability of differentiating into a number of other cells. Of course, that is the hope of embryonic stem cell research, that we might induce a cell to develop into a tissue, an organ or cells which will be useful in treating diseases.

This is a very abbreviated depiction of the early development of the embryo because it skips the morula stage, and we will come back to that in a few moments because that is the stage where most of the attention is focused now.

This goes from the zygote through the morula and finally, to the blastula and then to the gastrula. Here we see in the gastrula the development of what we call the germ layers. I guess you would say that a cell from each of these three germ layers, a cell from the endoderm, a cell from the mesoderm or a cell from the ectoderm, are all stem cells because they are destined to become a lot of different tissues and organs in the body.

From the ectoderm develops our nervous system and the skin. From the mesoderm develops most of the mass of the body, all of the bones and all of the muscles, the heart, the red blood cells and so forth. And then the endoderm, although widely dispersed in the body represents less mass in the body because it is the lining of the lung and the digestive tract. My chart shows the germ cells, the sperm in the male and the egg in the female.

Now there are cells in all of these that one could say were stem cells. Tissue, and blood is a tissue, the tissue which has the most obvious stem cell that students were taught at least 50 years ago when I first was studying these things, is the stem cell in the bone marrow from which a number of different blood cells develop.

When you are working with adult stem cells, if you want something other than the organs from which this cell could differentiate, then you need to de-differentiate the cell. In other words, you need to convince the cell that it is not exactly what it is as a result of the development process, that it returns to its original undifferentiated, or relatively undifferentiated state, and then it can make other tissues.

The embryonic stem cells philosophically certainly hold the most promise because they are cells from which all of the tissues and organs of the body develop. There is the rationale then that these embryonic stem cells hold the promise of producing anything and everything that might be needed for fighting diseases.

There is enormous theoretical potential from working with stem cells. They are useful in treating diseases that result from tissue or organ deficiencies. We need to differentiate these diseases that result from the action of pathogens. There is a very large list of diseases that theoretically might be treated by stem cell application. Diabetes is one of those. It, by the way, represents the largest cost of all the diseases in this country.

This is probably the one that in my experience is the most heart wrenching because I have seen these little children come to my office. Many times during the day and frequently at night they have to prick their finger, their hand, their ear lobe, something in their body to get a drop of blood, and now we have new instruments that require a pretty small drop of blood, and then this new almost miracle instrumentation analyzes that blood to see what the glucose content is so that they know how to set that pump. Many of them have embedded in their side a little hockey puck size pump that pumps insulin.

This of all the diseases, Mr. Speaker, is the one that perhaps most obviously might lend itself to cure through stem cell research. Giving insulin to a diabetic does not cure the disease. It simply delays the inevitable. The person whether they are young or old will go on to have circulatory problems. They may lose their eyesight. Circulation in their legs may be so bad that their toes become gangrenous and have to be removed. When you see these little children come through your office suffering with this disease, your heart really goes out to them and you want to do everything that you possibly can to make sure that they have every potential for a healthy life. And they will not live so long, they will not live so well as the average person in spite of all the miracles of medicine today because insulin does not cure diabetes.

But if through embryonic or adult, for that matter, if you could do it, stem cell research, if you could develop islet of Langerhan cells, you could then put them anywhere in the body. In our bodies, they reside in the pancreas. I am not sure why because what they do and what the pancreas does are two very different things. The pancreas secretes a large number of enzymes for digestion in the small intestine and the islet of Langerhan cells just happen to be resident there. They could be anywhere. They could be in your tongue, they could be in your toe, they could be in your ear lobe. They could be anywhere as long as there is a blood supply there to pick up the insulin that is made by these islet cells.

There is a long list of diseases: multiple sclerosis, lateral sclerosis, Lou Gehrig's disease. I have personal familiarity with this because my grandmother died of this a number of years ago, and I remember as a little boy standing by her bedside as she deteriorated and finally the only way that she could communicate with us was by blinking her eyes. She could not move anything else. She had no other way to communicate with us.

There is a hope, realizable, who knows, until we conduct the research and do the medical experimentation, but there is a hope that one might develop from stem cells tissues that could be injected into people with multiple sclerosis or lateral sclerosis. Sclerosis, by the way, means a scarring. What happens is that there is a scarring that inhibits the function of these nerves.

Alzheimer's disease, that is frequently mentioned. That is a particularly tragic disease. Although it was not specifically diagnosed in my mother because she had other ailments that were easier to diagnose, she lived to be 92 and I am sure that she had Alzheimer's because she had many of the symptoms. It was really tragic to watch a woman who was very bright and vital lose her ability to remember, lose a sense of proportion, to be calling, Roscoe, Roscoe. I would say, I'm here. She said, oh, you're not Roscoe because my father was Roscoe, Sr. and she was way back 50 years earlier in her memory. There is a hope that stem cell research could help cure diseases like this.

I have here a very large number of autoimmune diseases. There are 63 of them here. I have mentioned a couple of them. Autoimmune diseases are diseases where the body fails to recognize itself, that is, the parts of the body that have to do with recognizing foreign invaders and assimilating them, ejecting them, killing them.

Very early in our embryonic development, we have a very special kind of life cell which we call T cells. Very early in embryonic development, they are imprinted with who you are. There are 6.5 billion of us in the world and these T cells are smart enough to recognize a difference. There may be somebody out there close to you, but nobody out there quite like you; and you try to take their body organ and put it in you, these T cells are going to recognize it as foreign and move to reject it. Sometimes for reasons we do not understand, these immune reactions in the body get confused, and they attack the body itself.

We have a large number. Lupus was probably the first widely recognized of

these diseases. What has happened is that when the body is attacked, the specific tissues of the body are attacked, they degenerate and become not useful. There is some evidence that the body develops an ability to recognize its own; and so the hope is that after this has happened, if you could replace the damaged tissues, that the person gets returned to normal function. There is enormous potential from use of stem cells, whether they are embryonic or adult, to cure many, many diseases.

The argument today is about whether it should be adult stem cells or whether it should be embryonic stem cells. We have been working with adult stem cells, Mr. Speaker, for over 3 decades, and so there have been a fair number of applications to medicine. You will hear the figure 58. We have been working with embryonic stem cells a little over 6 years. There just has not been time to make those applications, but the fact that there are presently no applications to medicine of embryonic stem cell work does not mean that there will not be and it does not mean that those applications might not be more efficacious than adult stem cell applications.

Indeed, if you will talk to the researchers and the experts in this area, they will all tell you to a man and to a woman that the potential for embryonic stem cell application to medicine should be greater than adult stem cell application just because embryonic stem cells, they are called totipotent, they can produce anything and everything that is in the body. The adult stem cells have already been differentiated, at least to some extent; and so they are limited in their potential application.

There is another very interesting potential that I do not hear often discussed of embryonic stem cells. Fifty years ago when I was studying and teaching in this area, there was an experiment where the researcher went into a mother black mouse and took a little patch of skin in the uterus from one of her little black babies and then he took that little patch of skin, and he went into the uterus of a white mouse with her white babies, and he cut a little patch of skin out of the white mouse and put in that little patch of black skin and when the white mouse was born with that patch of black skin, it did not reject it.

This gives the promise, Mr. Speaker, that there may be less rejection of tissues and organs developed from embryonic stem cells than from adult stem cells. I do not know whether this was a host or donor phenomenon. Both were embryos. All we know is that when the black skin was sewed onto the little embryonic mouse that there was no rejection. If you tried to do that after they were born, I do not know if we have determined at precisely what time they lose that ability, it certainly would have been rejected.

The debate that we are going to vote on tomorrow and the debate which was the subject of the Special Order just before I spoke has to do with whether or not we can effect the needed cures in medicine from adult stem cells or whether we need to move to embryonic stem cells to make this happen. Early in this debate, I had a personal involvement which was kind of an interesting one.

In a former life, I got a doctorate in human physiology. I taught medical school. I did medical research. I went out to NIH in 2001, before the President made his executive order. It was an information meeting at NIH where the scientists working in this field were briefing, they were largely staff members from the Hill. I think I was the only Member there. It occurred to me that you ought to be able to take cells from an early embryo without hurting the embryo, because nature has been doing that forever as far as we know. That is what happens in identical twinning.

I would like to look at the next chart. This is two zygotes. This is not identical twinning. I just wanted to contrast this with identical twinning. This is where we have fraternal twins. They are so-called wombmates. They could be two boys, two girls, one of each. They are conceived at the same time. The mother that ordinarily sloughs one ovum a month this month sloughed two ovums and the sperm, and there are a whole lot of those, millions of them, they found both of them and they fertilized both of them and the uterus was receptive so they both were implanted in the uterus. This simply shows how they present at birth, depending upon how they implanted. If they are implanted far apart, they present one way at birth. If they are implanted very close together, they present another way at birth.

The next chart shows twins from monozygotic twins, that is, from a single zygote, from a single egg. This presentation looks very much like the dizygotic, that is from two eggs, dizygotic twins that implanted in the uterus very close together. Knowing that in identical twinning, regardless at what stage it occurs and it can occur all the way from the two-cell stage clear up to the inner cell mass and there are several stages between these two, but no matter where it occurs, the embryo has lost half of its cells and both parts go on to produce a perfectly healthy baby.

So I reasoned that it should be possible to take cells from an early embryo without hurting the early embryo and I asked the researchers at NIH, was that possible. They said, yes, of course that is possible. But with all the embryos out there that could be simply destroyed to get the stem cells, nobody had determined how easy this was to do. But they said that it certainly was doable.

A little bit later, and this was again before the President gave his executive order, I met the President at an event and I told him very briefly that I had met with NIH, and there was this possibility that we could take cells from an early embryo without harming the embryo. He asked Karl Rove to follow up on that. Several days later, Karl Rove called me, Mr. Speaker, and he said, Roscoe, I went to NIH and I told them what you told the President, and they told me they cannot do that.

I said, Karl, there is some problem here. Either they misunderstood your question or something because these are the same people that go into a single cell and take out the nucleus and put another nucleus in the cell. Of course they can go into a relatively large embryo and take out a cell or two. He went back to talk with them again and called me back and said, they are telling me the same thing. And so the President came out with his executive order which said that Federal funds could be used in research only on the cell lines that had been developed from embryos that had been killed in the process of developing them, that no new cell lines could begin with embryos that had to be killed.

This is only with Federal money, of course. The private sector can do whatever it wishes because there is no law prohibiting the use of embryos. My concern, Mr. Speaker, is that we in Congress ought to be a player in this, and now we are standing on the sidelines.

Mr. Speaker, I see that the gentleman from Georgia (Mr. Gingrey) has joined us, and I yield to the gentleman.

Mr. Speaker, I appreciate my colleague's coming and entering into this discussion.

Before leaving this little experience with NIH, I will, Mr. Speaker, submit for the Record a letter which I received today from Dr. Battey, who is the spokesman for embryonic stem cell at NIH, and what the letter says is, and I will come back to it in a few moments to read a couple parts from it, that what we are proposing to do is certainly possible; that there is no medical or scientific impediment to doing this. I just wanted to put to bed the suggestion that NIH says what we are doing cannot be done in spite of the fact that that is what Karl Rove thought they said.

In my office just a few months ago, NIH kind of sheepishly admitted that there was some misunderstanding in conversation because they had never said that we could not go into an early embryo and take a cell. What they had said, which is true, which is why I am proposing this research, was that we have never developed a stem cell line from that early an embryo. Ordinarily, we develop a stem cell line from the inner mass cell stage of the embryo. But the earlier we get the stem cell, the more totipotent it ought to be and the more efficacious it ought to be in treating the diseases.

I have here, Mr. Speaker, a little diagram which shows the ontogeny, the development of the embryo. It begins, of course, with the egg that comes from the mother, the oocyte, and then the sperm, and it shows only four or five there. There will be millions there, I assure my colleagues. And there is really a miracle that occurs here because as soon as one of them penetrates that egg, there is a big barrier put up so that there is no other candidate. It would be quite disastrous if two of them penetrated that egg because that would create an embryo which would certainly die.

And then the egg, called a zygote, goes on to develop, and it is two cells. And it may split here to make two babies, by the way, identical twins. And then the four-cell and then the eight-cell stage. It is at the eight-cell stage, and I am jumping a little ahead here, it is at the eight-cell stage in a petri dish.

This is what happens in the body. If this kind of thing happens, they can fertilize it in a petri dish. It is at this eight-cell stage in more than 1,000 times now in clinics. It started in England. It is now in this country. They have gone into the eight-cell stage and taken out one cell. They might get two. And they then do a preimplantation genetic diagnosis on that. In other words, they determine whether or not there are any genetic defects like Down's disease, for instance, in which case they would not want to implant that embryo. They do this for the benefit of their baby because one would not want, if they had a choice, to bring a child into the world that was going to have a less than optimum quality of life because they had a genetic defect.

This is not genetic engineering. Genetic engineering is when they change the genetics. All they are doing here is seeing what genetics are there, and if there is no deficiency in the genetics, they implant the six or seven cells that remain, and more than 1,000 times they have had a normal baby.

All of this happened in the intervening years between 2001 and now. This may have been going on when I talked to the President and when I talked to NIH. I did not know that it was going on, but just a few months ago, this report came out, and now I spent the other day, for a half-hour, probably, talking with two investigators here in Virginia who are doing this.

I just want to spend a couple of moments talking about the debate. The debate is between the use of discarded embryos that the proponents, and that is what the bill is tomorrow, say are going to be thrown away anyhow and why do we not get some good from them by developing stem cell lines from them since they are going to be discarded anyhow?

The argument on the other side is twofold. First of all, it is not certain they are going to be discarded because they can be adopted. What is it? Operation Snowflake where parents can adopt one of these embryos and have them implanted in a mother other than the one from whom the ovum was taken. So it is not certain that they are going to be discarded.

The other challenge to this is that this is a life. In the proper environment, this is a human being. It is an

embryo. Put it in the mother's womb, and it will become a very distinct human being, unlike any other out of the 6.5 billion people in the world. And there are those who feel that it is immoral. The President is among them, and he has said this, that it is immoral to take one life so that we might help another.

The good news is, as the gentleman from Georgia (Mr. Gingrey) said, we do not have to do that because we can take cells from an early embryo without hurting the embryo.

By the way, umbilical cord blood stem cells are not an alternative to embryonic stem cells. Just a little quote here. This is from a scientist at the Johns Hopkins University School of Medicine, one of the best medical schools in the world: ``As a physician-scientist who has done research involving umbilical cord blood stem cells for over 20 years, I am frequently surprised by the thought from nonscientists that cord blood stem cells may provide an alternative to embryonic stem cells for research. This is simply wrong,'' he says.

Do they have a place in treating? Yes, they do. But they are not a substitute for embryonic stem cells, and he makes that very plain.

Opponents of embryonic stem cell research suggested that 58 diseases have been successfully treated using adult stem cells. That is true.

I asked NIH, is that true that we had 58 treatments from adult stem cells and none from embryonic stem cells?

They said yes, that is true. I said, why is that true? That is true because we have had more than 3 decades' experience with adult stem cells, and just a little over 6 years' experience with embryonic stem cells. There simply has not been time. All of the 58 listed, all of them, are represented by organizations that support stem cell research. So what this says is that all of those physicians that are involved with these 58 applications of adult stem cells, all of them support stem cell research.

The argument on the other side is that it is immoral, that we should not take one life to support another life; and in making those claims, they state the following: this kills human embryos. It does. You may not think that is a problem. You may not see this little bit of life that holds the miracle of chromosomes and against that will develop the whole unique individual, not like any other. Out of 6.5 billion in the world, you may not see that as human life, but it clearly is. It kills a human embryo. You may be okay with that, you may not be, but a great number of people are not okay with that.

They argue that H.R. 810, which is the bill we will be voting on tomorrow, is an empty promise because the embryonic stem cells have not treated a single human disease, and that is true. We just gave the reason for it: they have not been worked with long enough to know whether they can treat a disease or not.

H.R. 810 does not have 400,000 discarded embryos to use, that is true; and the statement is made that if you used these 400,000 embryos, you would only get 275 stem cell lines, and that is because only 2.8 percent of them have been donated for research. That gets you down to 11,000, not 400,000. Only 65 percent of those will survive the thawing. They are frozen. This is not an event that is not traumatic. It is very traumatic to the embryos. A third of them do not survive the freezing and rethawing.

Twenty-five percent of those that are still alive after they thaw, only 25 percent will go on through this development stage, through the blastula, gastrula and so forth, so they can be implanted. Then, even if it has gone that far, in one trial only one out of 18 attempts produced a stem cell line, and in another trial only three out of 40 produced a stem cell line. So that now gets you down to about 275.

Yes, we have not developed perfection yet in these techniques; but 275 stem cell lines is more than 10 times more than all the stem cell lines we have now, which, by the way, I think are almost all in this country contaminated with mouse feeder cells.

I see that we have been joined by my colleague from Nebraska. I would be happy to yield to the gentleman from Nebraska (Mr. Osborne) for his comments.

Mr. Speaker, reclaiming my time, I thank the gentleman very much.

Mr. Speaker, let me yield to the gentleman from Georgia (Mr. Gingrey).

Mr. Speaker, reclaiming my time, I thank the gentleman.

I have here a very recent report, ``Alternative Sources of Human Pluripotent Stem Cells,'' a white paper by the President's Council on Bioethics, and the next chart shows page 25 from this.

The highlighted part says: ``It may be some time before stem cells can be reliably derived from single cells,'' the process we have been talking about, ``extracted from early embryos and in ways that do no harm to the embryo,'' thus biopsy. ``But the initial success of the Verlinsky Group's efforts at least reaches the possibility that embryonic stem cells could be derived from single blastomas removed from early human embryos without apparently harming them.''

Then there is an asterisk, and if you go to the bottom of the page it says: ``A similar idea was proposed by Representative Roscoe Bartlett of Maryland as far back as 2001 before the President gave his executive order.''

There are four potential sources listed here. This source is number two. They do a very good job of discussing this in the body of the text. They talk about parents going for pre-implantation genetic diagnosis. They talk about the possibility that you could develop from the cell or cells taken a repair kit.

This is a fascinating potential. This is why we are collecting and freezing umbilical cord blood, because we hope that through the life of that person, there might be some opportunity to use stem cells. They are not embryonic, they have limited application, but maybe, just maybe, we could produce something that would help that person later on with a disease.

But in this case, if they did preimplantation genetic diagnosis and if they developed a repair kit from that, then all that we would ask for is that a few surplus cells from the repair kit could be made available for a new stem cell line.

But that is not even what our research, our paper, our bill asks for. What our bill asks for is simply Federal money to do research on animals, on nonhuman primates, that is, the great apes, which genetically are remarkably similar to humans, if it works there, it probably would work in humans, to determine the efficacy and the safeness of doing this.

Unfortunately, if all that you read was their recommendations, you would be disappointed, because they never therein mention that the parents have made an ethical decision to make sure they do not have a baby with a genetic defect, the parents who made a decision to establish a repair kit so that their baby at any time during their life could have available compatible tissue to fix a medical problem. They simply state in their recommendation section that they consider it unethical to go to an embryo and take a cell out of it just to establish a stem cell lot.

It must be that a different person wrote the recommendations at the end as compared to the person or persons that wrote the text in the front, because they certainly should have mentioned the parents' decision to develop a repair kit, the parents' decision to make sure that their baby did not have a defect. These are decisions that parents make, I think, ethically to the benefit of their baby and for all that we would hope in the future. And, again, our bill deals only with animal experimentation to determine the efficacy and the reliability of doing this.

The next chart shows another development chart, and I would just like to reemphasize: Now, imagine this is not in the mother; this is an infant dibulum, in the ovary and the fallopian tube here. Imagine that this is in a petri dish and not in the mother, and we fertilized the egg, and it has now developed to the eight-cell stage, and we can take a cell from that stage and do a preimplantation genetic diagnosis. Maybe, as the authors of the white paper said, you could develop a stem cell line from that. We do not know. They simply have not tried. It has been too easy to take and kill embryos to get stem cell lines from them.

There is one other ethical argument that maybe is a problem, Mr. Speaker. They address this in the President's white paper. They do not think it is a problem. When you read that white paper you will see that they are bending over backwards to satisfy all of the concerns that even the most concerned prolife person could have. They do not believe that you could develop an embryo from a single cell.

But if we waited a little later, and I have asked the researchers, the medical people who are doing this preimplantation and genetic diagnosis, if they could wait until the inner cell mass stage, if they could wait until the inner cell mass stage to take the cell. Now we avoid even that potential ethical argument, because we already have a differentiation that has occurred. There are now two kinds of cells in what we call the embryo. There is the inner cell mass, which will become the baby; and then there is the rest of the trophoblast which will become the decidua. The decidua is the amnion and chorion.

Now, you cannot have a baby without amnion and chorion; it cannot grow. So if you take cells only from the inner cell mass, they could never become an embryo because these cells have lost all of their ability to produce the decidua, but they retain all of the ability to produce the cells of the body, the great variety of cells in the body.

I am prolife. I have an impeccable, 100 percent prolife voting record. I would not be here on the floor today talking about a possible solution to this debate if I did not think that this was perfectly ethical and probably perfectly doable.

I hope, Mr. Speaker, that a number of my colleagues will sign on to our bill. We are going to hold this until about noon tomorrow, because we would like to get as many prolife signers as possible.

If the other bill reaches the President's desk, no matter what he decides, some people are not going to be happy. If he vetoes the bill, as he has said he would, then all of those Americans, and I believe it is a majority, as there will be a majority tomorrow that vote for H.R. 810, will wonder why it is not okay to take these embryos that hardly look like a baby, just eight cells, to take these embryos, and they are going to be discarded anyhow. And given the two arguments, they may not be discarded, they may be adopted, and at the end of the day, you are taking a life.

If you think it is okay to take one life to help another, that is okay, but a lot of people do not think that is okay. On the other hand, if he lets it become law, then he is going to offend all of those prolife people who really see this as life.

What I hope, Mr. Speaker, is that my bill can be on the President's desk when he is faced with the unhappy choice that he will have with this bill, so that he can now say, Gee, I have a bill which supports what I want, and that is embryonic stem cell research without harming an embryo.

We are not ready yet to work with humans. This bill addresses only animal experimentation. But as we saw earlier, Mr. Speaker, from this chart that we had from that page of the white paper, let me put that back up because I think it makes the point, it may be some time. That is why we have researchers and that is why we have money from NIH, because it may be some time before stem cell lots can be reliably derived from single cells. They believe that it is possible to do that. It may take some time, taken from early embryos in ways that do not harm the embryo. As we have pointed out, they will be taken to benefit the embryo, to do preimplantation genetic diagnosis and to develop a repair kit for the embryo.

But the initial success of the Verlinsky group's efforts at least raises the future possibility that pluripotent stem cells could be derived from single-blast embryos removed from early human embryos without apparently harming them. Indeed, if it is taken for preimplantation genetic diagnosis and to establish a repair kit, not only are they not harmed, they are benefited by it.

Mr. Speaker, I know that all America will be watching this debate; they just voted $3 billion in Alaska to pursue this. I believe we can pursue all of the potential miracles that could come from embryonic stem cell research and applications to medicine without harming embryos, and I urge an early vote and adoption of this bill.

Mr. Speaker, I submit the following for the Record:

Department of Health

and Human Services,

Washington, DC, May 23, 2005.

Hon. Roscoe G. Bartlett,

Rayburn House Office Building,

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 pre implantation 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 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 longterm 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 Stern 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.,

Chairman, NIH Stem Cell Task Force.

Enclosure.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2520) to provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and research, and to amend the Public Health Service Act to authorize the C.W. Bill Young Cell Transplantation Program.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks on this legislation and to insert extraneous material on the bill.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in strong support of H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005, legislation I have cosponsored along with the honorable gentleman from New Jersey (Mr. Smith), who is in the Chamber. This would expand the number of stem cell options available to Americans suffering from life-threatening diseases.

Every year, nearly two-thirds of the approximately 200,000 patients in need of a bone marrow transplant will not find a marrow donor match within their families. These patients must rely on the help of strangers to donate bone marrow for a transplant. To assist these patients, Congress established the National Bone Marrow Registry to quickly match donors to patients. Through this program, Congress made a significant investment to connect patients with a rich source of stem cells that offer immediate clinical benefits.

With scientific advances, Congress must now make changes to reflect new

therapeutic options. Cord blood units have been shown to be a suitable alternative to adult bone marrow for the treatment of many diseases, including sickle cell anemia. This is an especially important advancement for those Americans who have desperately searched for a marrow donor but could not find a match with even the help of the National Bone Marrow Registry. As another rich source of stem cells, a cord blood transplant is another chance at life for many of these patients.

The bill before us today builds on the critical investments we have made over the past 2 decades with the National Bone Marrow Registry and retools this design into a new, more comprehensive stem cell transplantation program, which will include not only bone marrow but also cord blood units. Through a competitive contracting process, this new program will allow transplant doctors and patients to access information about cord blood units and bone marrow donors, at the same time, and I want to emphasize at the same time, through a single point of access. This new program does not create a preference for either cord blood or bone marrow. Instead, it will provide comprehensive information about both sources of stem cells to doctors and patients and allow them to make the most clinically appropriate choice.

I want to recognize the gentleman from Florida (Mr. Young) at this time. It was the gentleman from Florida's (Mr. Young) drive, when he was chairman of the Committee on Appropriations, and his steadfast support for the idea of a national registry for bone marrow that led to the program's creation. The gentleman from Florida's (Mr. Young) lifesaving work is evident again today in the program's new design and goals. I am pleased that Congress is recognizing his dedication by naming this new program the C.W. Bill Young Cell Transplantation Program. I do not see the gentleman from Florida (Mr. Young) in the Chamber, but at the appropriate time when he does arrive, I hope that the body will give him a standing ovation for his work in this area.

The capacity to search for cord blood units through a national network of cord blood banks will help facilitate cord blood transplants. We also need to expand the inventory of cord blood units so that more transplants can occur. The bill before us today authorizes a new grant program to provide subsidies to cord blood stem cell banks to expand the inventory of high-quality cord blood units that will be included in the new, expanded Cell Transplantation Program. I think that number is 150,000 units, which is a significant increase.

In addition to expanding the number of cord blood units available for clinical use to save lives today, the bill would also expand the number of cord blood units available for research. Research on adult stem cells holds the potential to develop new cures for many diseases, as well as to expand our knowledge of how human beings develop and the body works.

I would also like to make a personal aside here. My wife and I are expecting a child in September, and we are working with the cord blood people as we speak so that my son, and it is going to be a little boy and we are going to name him Jack Kevin, that we are going to save his cord blood so that some day in the future, if he needs it, it will be available. So in this case I can honestly say, in addition to sponsoring the bill, I am beginning to practice what I am preaching today.

It is not enough to connect patients with lifesaving donors. We also need to better understand how these patients fair when they receive the transplants. The bill would authorize research on the clinical outcomes of patients who are recipients of a stem cell therapeutic product, including bone marrow, cord blood, and other such products, from a biologically unrelated donor. It is my hope that this additional research will trigger new scientific breakthroughs to enhance and advance human life.

This is an important bill that merited many hours of negotiation, demanded the willingness of all those involved to put the interest of their patients first. I would like to thank the bill's primary sponsor, the honorable gentleman from New Jersey (Mr. Smith). I would also like to thank the gentleman from Florida (Mr. Young); the House leadership, including the honorable gentleman from Texas (Mr. DeLay); Congressional Black Caucus; the gentleman from Michigan (Mr. Dingell), the ranking Democrat on the committee; the gentleman from Ohio (Mr. Brown), the subcommittee ranking member who is here to speak on the bill; and all of the staff who have labored on this bill.

Particularly, I would like to thank Cheryl Jaeger, on my left, of my committee staff, for all of her efforts. She has been tireless in the last several months working on this bill. In the last few weeks, she has been able to forge a compromise that ultimately was acceptable to all the advocates of both bone marrow and cord blood.

We will continue to improve the legislation that moves forward so that pregnant women are informed of all of their options with respect to cord blood donation and the programmatic activities of the Cell Transplantation Program are clarified.

Mr. Speaker, at the appropriate time, I would urge all of my colleagues to support this bill. It is good legislation, well thought out, and deserving of majority support.

The Stem Cell Therapeutic and Research Act of 2005 Establishes a

Foundation for Improving Access to Lifesaving Cellular Therapy

Transplants

The National Marrow Donor Program (NMDP) is pleased that

the sponsors of the Stem Cell Therapeutic and Research Act of

2005 have taken a positive step forward toward expanding the

long-standing Congressional commitment to cellular transplant

therapies by introducing legislation to continue Federal

support for bone marrow, peripheral blood, and umbilical cord

blood transplantation and research. Through the legislation

introduced today, they acknowledge the important role

Congress has played and must continue to play in ensuring

that the more than 14,000 Americans in need of these types of

transplants have access to them.

The bill calls for Federal dollars to increase the number

of umbilical cord blood units available for transplant and

research. Currently, there are 42,000 units available through

the existing National Bone Marrow Donor Registry (National

Registry), which also lists more than 9 million adult donors

worldwide. With additional umbilical cord blood units added

to this registry, more Americans who would otherwise not be

able to locate a suitably matched adult donor will be able to

find hope through a cord blood transplant. The NMDP estimates

that with access to the existing adult donors and units, the

addition of 150,000 cord blood units listed through the

existing registry will provide a match for approximately 95

percent of Americans.

By designating the existing National Registry as the C.W.

Bill Young Cell Transplantation Program, the sponsors have

acknowledged Representative Young's unwavering commitment to

the National Registry and its growth. In 1986, Representative

Young's vision of a single integrated national bone marrow

donor registry became a reality. Since that time, the

National Registry has facilitated more than 21,000 unrelated

transplants involving cord blood, bone marrow, and peripheral

blood. It now includes more than 5 million U.S. adult

volunteer donors and has links to another 4 million

worldwide. As evidence supporting cord blood as a source of

the same cells found in bone marrow and peripheral blood has

grown, the National Registry, operated by the NMDP, has

expanded to include more than 42,000 cord blood units through

the NMDP's partnership with 14 of the 20 U.S. public cord

blood banks. We join the sponsors in saluting Representative

Young's dedication to helping the thousands of Americans in

need of these types of transplants.

The expansion of the Program will benefit patients most if

they are able to access the new sources of cells easily and

efficiently. The NMDP supports the intent of the sponsors to

provide patients and physicians with access to cord blood,

bone marrow, and peripheral blood stem cells through a single

point of access. To ensure the continued expansion of cord

blood transplants, it is important that patients and

physicians can search for all of these sources through a

single registry, compare each source of cells for transplant

quickly and efficiently, and obtain the cells once the search

process is finished. One-stop-shopping to obtain information

and logistical support is a critical component of the success

of transplantation regardless of whether adult donors or cord

blood units are used. The bill recognizes this need by

calling for a single point of access for these activities to

build upon the National Registry. Using the current registry

as a basis for the new program will ensure that limited

resources are dedicated to increasing the availability of

matches and not in reinventing new bureaucracies.

Although this bill is a step in the right direction, it is

critically important that the Program also have the authority

to establish criteria and standards that provide transplant

physicians with the assurances they

need to be confident that when they compare various cord

blood units and/or adult donors, they have the same type of

information about each unit or donor. In addition, the NMDP

urges members to recognize that transplant patients may

encounter other barriers to accessing cellular therapy

transplants. The need for assistance in addressing barriers

to access should be extended to all recipients of transplants

under this program, regardless of cell source. Physicians and

patients must be able to receive all of the services

necessary for a successful transplant, including distribution

coordination, patient counseling, translation assistance,

testing, insurance coordination, and other patient advocacy

services. We look forward to working with the sponsors and

the Department of Health and Human Services to strengthen

these provisions of the legislation.

The NMDP applauds the sponsors for undertaking this

important public health initiative. Through their leadership,

thousands of Americans who might otherwise die will have

access to lifesaving bone marrow, peripheral blood stem cell,

and cord blood transplants.

Mr. Speaker, I ask unanimous consent that debate on this motion be extended by 20 minutes, equally divided between myself and the gentleman from Ohio (Mr. Brown).

Mr. Speaker, I yield 5 minutes to the gentleman from New Jersey (Mr. Smith), the original author of the bill and my cosponsor.

Mr. Speaker, I yield 2 minutes to the gentleman from New Jersey (Mr. Ferguson), a member of the Committee on Energy and Commerce.

Mr. Speaker, I yield 2 minutes to the distinguished gentleman from Florida (Mr. Weldon), a doctor, and one of our more thoughtful Members on this subject and somebody who has given a lot of time to it.

Mr. Speaker, I yield 2 minutes to the gentleman from California (Mr. Daniel E. Lungren).

Mr. Speaker, I yield 15 seconds to the gentleman from New Jersey (Mr. Smith), very briefly.

Mr. Speaker, I yield 2 minutes to a member of the committee, the distinguished gentleman from Pennsylvania (Mr. Murphy).

Mr. Speaker, I yield 1 minute to the gentleman from Georgia (Mr. Gingrey).

Mr. Speaker, I yield 1 minute to the distinguished Majority Leader of the great State of Texas (Mr. DeLay), Fort Bend County, Sugarland.

Mr. Speaker, I yield 1 minute to the gentleman from Georgia (Mr. Price).

Mr. Speaker, I yield 1 minute to the gentleman from Indiana (Mr. Pence), the distinguished leader of the Republican Study Committee.

(Mr. PENCE asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I have three willing speakers now and more on the way.

Mr. Speaker, I yield 1 minute to the gentleman from Pennsylvania (Mr. Pitts), a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from Delaware (Mr. Castle), the distinguished Congressman and former Governor of the first State of our Union.

Mr. Speaker, I yield 1 minute to the gentlewoman from Pennsylvania (Ms. Hart).

Mr. Speaker, I have one speaker remaining, and I will close.

Mr. Speaker, I yield 2 minutes to the gentleman from Florida (Mr. Weldon).

Mr. Speaker, I yield 1 minute to the distinguished gentleman from the Keystone State of Pennsylvania (Mr. Weldon).

Mr. Speaker, how much time remains?

Mr. Speaker, I yield myself the balance of my time, and I want to thank the majority leader and the Speaker for bringing these two bills to the floor today.

The first vote we will have is on the cord blood and bone marrow bill, H.R. 2520. This bill, by itself, is an extremely important advance for those of us that believe you can use medical research ethically to help find cures for existing disease and enhance human life both now and in the future.

I am, obviously, as one of the original sponsors of the bill, going to vote for it and encourage all the Members on both sides of the aisle to vote for its. It is a good piece of legislation and, by itself, is a major advancement in the state of the art that we have today.

The next debate that we will have is on the Castle-DeGette bill which is another form of stem cell research, embryonic stem cell. That issue is much more controversial, but on its own merit that bill itself deserves a serious debate. And while it is not yet time to debate that bill, at that time I will announce that I will vote for that bill also.

So I hope we can do first things first. Let us pass in a strong bipartisan fashion the Smith-Barton-Young adult cord blood bone marrow bill, and then go on to the next issue.

Mr. Speaker, pursuant to the order of the House of Monday, May 23, 2005, I call up the bill (H.R. 810) to amend the Public Health Service Act to provide for human embryonic stem cell research, and ask for its immediate consideration.

Mr. Speaker, I ask unanimous consent that the gentleman from Texas (Mr. DeLay) be given 45 minutes of the debate time on the pending bill.

Mr. Speaker, I ask unanimous consent that the gentleman from Delaware (Mr. Castle) be allowed to control 20 minutes of the remaining 45 minutes that I currently have control over.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and to insert extraneous material on the pending bill.

Mr. Speaker, I yield myself 5 minutes.

(Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I have a prepared statement I am going to put into the record on this bill, H.R. 810, but I am going to actually speak from the heart because I think that this is a very important issue.

Most of the issues that come before this body, there is an automatic position on. It may be the Republican position, the Democrat position, the Texas position, or it could be the committee position. And we come to the floor and we, almost by rote, say what is the particular position, and that is the way we vote.

But every now and then an issue comes up that is really an issue of conscience. It is an issue that deserves to be thoughtfully considered, debated, and decided on its own merit.

Now, there are many Members today that believe this particular issue is an issue that they feel so strongly about, on either side, that this is an easy issue for them, it is an automatic issue. They are going to be for it or against it for very valid reasons. But there are some of us, and I am in that camp today, that believe it is not an easy issue.

I come to the floor as a 100 percent lifetime voting member on prolife issues, minus one vote, in over 21 years. On all the votes that the prolife coalition at the State and Federal levels have scored as scorable votes, my record until this year was 100 percent, and I voted the wrong way on one issue so far this year from the prolife position. So that is not a bad record, 100 percent minus one. And after this vote today, I am going to be 100 percent minus two.

Why is that? Well, part of it is personal and part of it deals with tragedies in my family in the past. My father died of complications of diabetes at the age of 71. My brother, Jon Kevin Barton, died of liver cancer at the age of 44. My first granddaughter, Bryn Barton, died in the womb 2 days before delivery with complications of the umbilical cord, which had become crimped, and she was actually born dead.

Maybe the research we are debating today could not have helped any of those diseases or could not have helped my granddaughter, but maybe it could.

I am also going to vote for Castle-DeGette because of the future, not just the past. My wife Terri and I are expecting a baby in September, Jack Kevin Barton, named after her late father and my late brother, Jon Kevin Barton. He may come into this world with some disease. Hopefully not. I have three children that are already alive, Brad, Alison, and Kristin. I have two stepchildren, Lindsay and Cullen. I have three grandchildren that are living, Blake, Brent and Bailey Barton. Maybe they will live healthy, productive lives and they will never need some therapeutic breakthrough, but maybe they will. Maybe they will.

Now, we just voted for an expansion of cord blood and bone marrow research, which is a very, very good deal, and it deals with adult stem cells. And maybe the breakthrough is going to come in adult stem cells. I hope it does. I would love it. But maybe, just maybe, it is going to come because of embryonic stem cells.

Now, the President adopted a position in early 2001 that said the existing stem cell lines then in existence could be federally funded for research. They thought there were about 78 lines. It turned out that there were 22 they are using, there are 16 that are frozen, and there may be one or two more that might be used. But in any event, none of those lines that are currently allowed to be used for research purposes at the Federal level have been shown to have that breakthrough stem cell.

There are 200 adult cells in the body. The hope of stem cell research, whether it is adult or embryonic, is that we will find that one perfect cell that can be replicated into any of the other cells.

It is assumed, and it is an assumption, not a fact, that the plasticity of the embryonic cell is better and that there is a greater likelihood, although the research has only been done for the last 7 or 8 years, that there is a likelihood there might be a greater potential. And I want to emphasize might be.

So where I come down is, let us look at all the avenues.

We just voted for Smith-Barton-Young. Let us also vote for Castle- DeGette and look at all of our resources. That is why I am going to vote ``yes.''

Mr. Speaker, I rise to manage the time of debate on H.R. 810, legislation designed to expand the number of sources of embryonic stem cell lines that may be the subject of federally funded research. The bill is straightforward, yet the policy concerns surrounding this bill are anything but black and white. Before I yield time to my colleagues, I want to clarify a few of the following facts.

What the sponsors of this bill are trying to do is create enough lines of embryonic stem cells to allow basic scientific research to move forward. Many scientists believe that once we can identify a perfect, undifferentiated stem call, it will lead to significant scientific breakthroughs and the discovery of cures for many diseases.

Currently, there are approximately 22 lines of embryonic stem cells that are available for federally funded research. This number is far below the estimated number of stem cell lines that were thought to exist in August of 2001, when the President announced his stem cell policy. When President Bush announced that Federal research dollars could be used for the first time on then existing stem cells, it was believed that there were at least 60 viable lines of stem cells that could be used for this research. For a variety of reasons, not all of these potential lines are now available for research.

We will also eventually need additional embryonic stem cell lines to make further scientific advances. In recent conversations with leading stem cell researchers, they indicated to me that all lines of embryonic stem cells eventually become exhausted. In order to produce clinical therapies, it is likely that researchers will also need more embryonic stem cell lines, of different genetic variations, than are presently eligible to receive Federal support.

In addition, the majority of the existing embryonic stem cell lines eligible for Federal support use mouse feeder cells, which will make it nearly impossible for these embryonic stem cell lines to be adopted in clinical use. For all of these reasons, researchers believe that the current number of embryonic stem cell lines will have to be increased.

It is difficult to take an ideologically pure position on this issue. President Bush recognized this on August 9, 2001. On recognizing the profound potential benefits of embryonic stem cell research, President Bush permitted for the first time Federal taxpayer dollars to be spent on embryonic stem cell research.

For my entire career in Congress, I have been a staunch defender of the culture of life and opposed all forms of abortion. At the same time, I believe we have an obligation to improve existing lives and do what we can to make them better in the future.

Today, on this difficult issue, Members will need to vote their consciences. My decision to support this bill was a difficult one, which I came to only after much personal struggle and reflection. My decision was shaped, in part, by the painful experiences of my own family. We lost my brother Jon in 2000, at the age of 44, after a long struggle with liver cancer. My father died after suffering from complications resulting from diabetes.

Let me tell you for a moment about my brother, Jon. He was younger than me. He and his wife, Jennifer, had two children, Jake and Jace. He was a State district judge in Texas. They told Jon he had liver cancer when he was just 41 years old. We tried everything and, in fact, his cancer went into remission. The next year, it came back. Jon died in just three months short of his 44th birthday. I offered to give him part of my liver, but the doctors said he was too far-gone and it wouldn't work. That was five years ago. Jake is now 15, and Jace is 12. Every time I see them and their Mom, I think of Jon and wonder what stem cell research could have done for our family.

I cannot know the truth with absolute certainty, but my heart says that my brother and my father might be with me today if their doctors had access to treatments from stem cell research. Their lives were precious to me and to our family. I come to my decision on this vote because I believe in life, and in the future. If a vote today can save other families from losing brothers and fathers, my conscience will not permit any other decision.

I fully understand that some will say I am just wrong, or blinded by personal emotion. Many who disagree with me are my friends, and I completely respect their views and their advice. They are good people, and good people with the same facts sometimes come to different conclusions. Now, a few others will say that death is simply a part of life. No, it is not. I do not believe that we can ever accept that proposition without setting out on an extraordinary and dangerous path. Life is to be cherished and extended, and death is to be fought and never accepted.

My father and my brother died because illnesses took them. If I can do something to cure illness and thwart death for other families, I will because I must. Scientists believe that expanded embryonic stem cell research holds the potential to find cures for diseases like cancer or diabetes. It is my hope that supporting this bill will mean that many other American families will never have to endure the suffering and loss that my family went through. I believe that my obligation is to help advance science to make human life better now and in the future, in a manner that is consistent with Judeo-Christian ethics.

As we move forward with debate on this bill, my only request is that my colleagues try to respect one another and the deeply held beliefs on both sides of this very complex issue.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 1 minute to the gentleman from California (Mr. Cunningham).

Mr. Speaker, I yield 2\1/2\ minutes to the gentlewoman from California (Mrs. Bono), a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from Texas (Mr. Burgess), member of the committee.

Mr. Speaker, I yield 2 minutes to the gentleman from New Hampshire (Mr. Bass), a member of the committee.

Mr. Speaker, I yield 1 minute to the gentlewoman from North Carolina (Mrs. Myrick), who is a member of the Committee on Energy and Commerce.

(Mrs. MYRICK asked and was given permission to revise and extend her remarks.)

Mr. Speaker, I yield 2 minutes to the gentleman from the great State of Missouri, the Show Me State (Mr. Blunt), the distinguished majority whip.

Mr. Speaker, I am prepared to recognize the gentleman from Pennsylvania (Mr. Pitts) if the gentleman from Texas (Mr. DeLay) also wants to recognize him at this time. I yield him 1 minute.

Mr. Speaker, I yield myself 2 minutes.

Mr. Speaker, just speaking to the Members perhaps back in the offices listening, I have 820,000 constituents in Delaware, and probably more than a third of them have some kind of a disease that might be able to be benefited by embryonic stem cell research.

That is true of the figures in the country. We have 110 million people who have illnesses out of the 290 million people who are living here. They have visited my office. They have visited your offices. There is not a person in this room who has not had many, many visits by people who have very, very serious needs, whose lives are going to be shortened.

I am all for the first bill we debated today because I think it might help somewhat, but I have also looked at some statistics and I have come to realize that of the 15 leading diseases, adult stem cells cannot do anything about 14 of them and can do a only little bit about heart diseases as they deal with only blood diseases in terms of what they can do. Embryonic stem cell research has the ability, perhaps, to do much more than that.

People are going to get up and they are going to say, well, it hasn't done anything yet. They were only discovered about 6\1/2\ years ago. If you read the vast body of research in the United States of America on this subject by people who are truly knowledgeable, you are going to learn there is more potential here than anything that has ever happened in medicine in the history of the United States of America. Congress should never, ever turn its back on this opportunity.

How are we going to get there? How are we going to do embryonic stem cell research? I do not have time to go through the whole in vitro fertilization process except to say that we create embryos in that particular process. They are then frozen. They are generally used and well used, the 400,000 embryos which are out there, to help give birth to people who might not otherwise be able to have a child. But at the end of the process, a decision is made by the individuals that may be involved with that. If the decision is they no longer want that particular embryo, they may do a variety of things with it. They may, as has been discussed here, give it up for adoption. They may decide to have it discarded as hospital waste. That is where the vast, almost all of them actually go as hospital waste.

We want to give them the opportunity to say, within that embryo there are stem cells which could help other people live better lives and give them the opportunity to be able, instead of having it put in a bag for hospital waste, sitting at that table, to be put over here, and the State to be able to do the research. That is what we need to do. We need to be able to develop that as rapidly as we possibly can for the benefit of all mankind.

Mr. Speaker, I rise today in support of H.R. 810, the Stem Cell Research Enhancement Act.

I have been in public office for over 30 years and throughout my career, I--just like all of you--have had the opportunity to change and improve public policy so this country may continue to flourish on the principles it was founded. And the 820,000 people I represent in the State of Delaware are a constant reminder to me of this responsibility. I am their voice in the Congress of the United States.

Some of you may be wondering why I have become so interested and involved in embryonic stem cell research. And frankly, the answer is simple--those 800,000 constituents.

We estimated that about one-half of all visits to my office are about health care and about one-half of those visits are by Delawareans who are suffering themselves or whose family members are suffering--from juvenile diabetes, Alzheimer's, cancer, Parkinson's, HIV and hosts of other dredge diseases. Year by year the groups would grow in number and soon we would have to get bigger rooms for our meetings.

In the early years we would discuss the necessity of funding the National Institutes of Health, and I was proud to be able to support Newt Gingrich and the Republican Party's drive to double funding for the NIH. And that funding has gone toward the basic science needed to find cures and treatments to our most debilitating diseases. But in the past few years, the number one topic on these groups' minds was embryonic stem cell research.

One little girl stands out in mind. I met her a few months ago at an event back in Delaware. Olivia was two months old when she was diagnosed with type 1 diabetes. Her parents were first time parents so it is no wonder that the practice of testing her blood sugar and giving her insulin shots was extremely heartbreaking. Olivia is now 6 and has never known life without diabetes. She is the person we are fighting for on the floor today.

She is one of 110 million people who are suffering that may be helped by stem cell research.

I remember very clearly the difficult decision President Bush made on August 9, 2001 and I know how careful he was to balance the needs of science with his own moral concerns. At the time, the compromise--to allow Federal funding for research on embryonic stem cells lines that had already been derived--seemed quite reasonable. But as we know, unfortunately, the number of lines eligible for research--once as high as 78--is now only at 22, with the NIH saying the number of lines will never get above 23.

So when Diana DeGette and I began discussing how to expand the President's policy in an ethical manner, I went right back to the speech he gave to the Nation in 2001. We wanted to be as consistent as possible with the ethics he laid out in his speech as we worked to update the policy. The legislation we are going to vote on today, H.R. 810, the Stem Cell Research Enhancement Act, which has the backing of the medical groups, the scientists, the research universities and the patient advocacy groups, mirrors the President's ethical requirements.

I will read them to you and ask that you think about them very closely:

(1) Embryos used to derive stem cells were originally created for fertility treatment purposes and are in excess of clinical need;

(2) The individuals seeking fertility treatments for whom the embryos were created have determined that the embryos will not be implanted in a woman and will otherwise be discarded; and,

(3) The individuals for whom the embryos were created have provided written consent for embryo donation and without receiving financial inducement. You may ask what is different--we simply lift the arbitrary August 9, 2001 date.

It is also critical that we are clear about what this legislation does not do:

(1) No federal funding for the destruction of embryos or human life. This is prohibited by law.

(2) No federal funding for the creation of embryos for research.

Under our legislation it is up to the couple to decide what should happen to their embryos. Embryos can be adopted or donated; embryos can be frozen for future family building; embryos can be discarded. After that initial decision is made, and if a couple decides to discard the embryos, our legislation would allow those couples to make a second choice--do they want to donate them to research?

An embryo or blastocyst is about 250 cells and the inner cell mass is about 100 cells and that is where the stem cells come from. They are created in a petri dish, are about 5 days old and are the size of a pine head. Of the 400,000 frozen embryos in in vitro fertilization clinics throughout the U.S., about 2 percent are discarded annually-- that is about 8,000--11,000 embryos that could be slated for research. Allowing the option of donating these excess embryos to research is similar to donating organs for organ transplantation in order to save or improve the quality of another person's life.

The bottom line is when a couple has decided to discard their excess embryos they are either going to be discarded as medical waste or they can be donated for research. Throughout this debate you will hear about adult stem cells and more about umbilical cord cells and how these types of cells are sufficient for scientists.

This is simply not true. Umbilical cord cells are adult stem cells and they are limited.

Adult and umbilical cord cells are already differentiated into the types of cells they are, they are difficult to harvest and grow and they do not exist for every tissue type. On the other hand, embryonic stem cells are ``master cells''--they have the potential to grow into any type of cell in the body, they are easier to identify, isolate, purify and grow and they are capable of continual reproduction.

Listen to what the NIH has to say on this topic:

Human embryonic stem cells are thought to have much greater

developmental potential than adult stem cells. This means

that embryonic stem cells may be pluripotent--that is, able

to give rise to cells found in all tissues of the embryo

except for germ cells rather than being merely multipotent--

restricted to specific subpopulations of cell types, as adult

stem cells are thought to be.

In 2003, 1.6 million people died of heart disease, cancer, diabetes, Alzheimer's, kidney disease, liver disease and Parkinson's. Of the 15 leading causes of death, adult stem cell research only addresses one. Adult stem cells have been around since the 1960s. Embryonic stem cells were only isolated in 1998. We must explore research on all types of stem cells, but the reality is the only policy that is restricted is the Federal embryonic stem cell policy.

The NIH is the right place to oversee this research because it can regulate the ethics, it provides for scientific collaboration and peer review and promotes publication so all breakthroughs are reported and all scientists have access to the latest research discoveries. Without NIH oversight there are no guidelines as to how this research should be conducted.

The United States has always been the premier leader in biomedical research in our country and around the world. As science continues to move rapidly forward, we need to continue to lead the way but we are not. Why should we waste one more year, one more day, forcing millions to suffer because of a policy that is outdated and unworkable.

Does this Congress really want to look back 10 years from now and say that we were the ones holding the treatments up? Or do we want to be the Congress that says, we back science, we want research to flourish and we played a small role in making that happen.

Support H.R. 810, the Stem Cell Research Enhancement Act and accelerate hope.

Mr. Speaker, I yield 1 minute to the gentleman from California (Mr. Cunningham).

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 1 minute to the gentleman from Virginia (Mr. Tom Davis).

(Mr. TOM DAVIS of Virginia asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield 30 seconds to the gentleman from New Hampshire.

Mr. Speaker, I yield 1 minute to the gentlewoman from Illinois (Mrs. Biggert).

Mr. Speaker, I reserve the balance of our time.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, this debate we are having surrounding H.R. 810, the Stem Cell Research Enhancement Act, is really one of the most fundamentally important debates that this body can undertake. Regrettably, this discussion will only last a few hours on the floor of the House of Representatives today.

There have been no hearings on this bill or on the previous stem cell bill. H.R. 810 addresses the most fundamental, basic, ethical issue: life, and when does it begin; when should life, including human embryos, be open to experimentation and scientific research.

Those of us who believe in the sanctity of life from conception to our last breath, find the logic of the proponents of embryonic stem cell research flawed. H.R. 810 allows research and science to triumph philosophy and values.

This country seeks to be a world leader militarily, economically and scientifically, and culturally. But what about morally and ethically? What about leading the world in ethics and morals by declaring human life off limits to research and to manipulation through stem cell research? What about leading the world in ethics and morals by declaring human life from embryonic stage to old age as valued? We, as a Nation, believe that all life is precious and there is an ethical line that we as a people, as a Nation, will not cross.

We should lead by declaring that human life, even at the embryonic stage, is not open to manipulation, experimentation, or research. We cannot mask the efforts to manipulate human life under the guise of science or medical research.

You and I, each of us, we all share one thing in common: we were all embryos at one time. The embryos that were you and me were allowed to grow to become Congressmen, Congresswomen, police officers, factory workers, soldiers, government employees, lawyers, doctors, scientists. We were all embryos at one time. We were all

allowed to grow. Whether an embryo, a human life, is or is not allowed to grow, to become a unique individual, is a discussion this country really should have, a meaningful discussion, not just a few hours of debate in this Chamber.

It is my hope that families, individuals, couples and our children will have a discussion on human life and when it begins. Is an embryo life? At what point does an embryo become life? At what point does our Nation shelter life with the constitutional, legal, and governmental safeguards? Are there other ways to do promising medical and scientific research without destroying human embryos?

This is an ethical discussion I hoped would take place in the Halls of Congress, in the congressional committee rooms, in homes and workplaces all across America. Whether it is at the watercooler or in the cloakroom, these ethical and moral issues should and must be discussed as a Nation, as a people, as a culture, and as a world leader. Instead, this will only be discussed for a few hours on the House floor.

The other body has just gone through public, political, and senatorial debate on the use of a filibuster in our democracy. Because of this debate, a healthy discussion occurred in America. I, for one, do not wish to avoid the moral and ethical issues of stem cell research debate.

Yesterday in a news show, the commentator asked me why not allow stem cell research on discarded medical waste. Is that what we have come to, to viewing embryos, which if allowed to grow and divide would become human beings, being treated as medical waste? Why are proponents of H.R. 810 so adamant that we do research specifically using embryonic stem cells? According to the proponents of this legislation, these stem cells are our best hope of finding cures. They can develop into all cells of the body. They say medical science can unlock the keys to life. We can cure any disease or injury. They argue we must create life and then kill it to unlock the mysteries of life for scientific medical research.

Create and clone the building blocks of life so we can manipulate and experiment? Is that the line we wish to cross today? We will hear today about other research with adult stem cells, cord and placenta cells, bone marrow, fetal tissue, and unraveling our DNA through mapping of genome, all in the pursuit of finding medical cures for the dreaded diseases, illnesses, and injuries we all wish to cure. But where do we draw the line on medical research and say we as a Nation, we as a people will not cross that line? This question has not been adequately addressed in this legislation.

When do embryos become life? If you read the materials, after 40 hours, less than 2 days, the fertilized egg begins to divide and the embryos are checked after 40 hours. Or is it 5 days when embryos are called blastocysts? At this stage there are approximately 250 cells. Or do we allow the blastocysts to survive in a laboratory culture for up to 14 days and still not call them human life but blastocysts so they are still open to research and experimentation?

When does life become scientifically nonexistent?

I ask these questions because H.R. 810 is silent on these issues. It does not specify how long these embryos are allowed to grow before they are killed--2 days, 5 days, 14 days or more. Proponents of H.R. 810 will claim that their legislation will address the ethical manner in which this research will be conducted. Yet their legislation is silent on the ethics, other than subsection C that directs the Secretary of HHS to create guidelines within 60 days.

Two presidential bioethics advisory panels have given us differing guidance on when and how research should be conducted. If this Nation, through its elected leaders, allows embryonic stem cell research, then we as representatives of the American people should have the courage to state unequivocally where we stand and answer the ethical questions presented before us here today. As elected leaders, we should set some basic guidelines, not leave the guidelines to unelected and unnamed administrative officials.

I know many Members on both sides of the aisle, of all political philosophies, have struggled with questions of morality, questions of life and questions of faith this past week. Many of us have asked ourselves that same question, and I have concluded that this legislation is unethical and unnecessary.

H.R. 810 mandates Federal tax dollars to be used to destroy human embryos. These embryos, if allowed to live, would grow into beautiful children like the snowflake children visiting the Capitol today. They are human life. You, I and they were embryonic stem cells that were allowed to grow.

Congress should not take lightly the destruction and manipulation of human life. It is clear that the American public does not. Forty-three percent of the American public clearly opposes more Federal funding for human embryonic research. Fifty-three percent clearly support more Federal funding, according to CNN.

As I said before, this legislation has no limits as to how long the embryo can grow. The National Academy of Sciences' guidelines recommends allowing them to grow for no more than 14 days.

Again, this legislation is not necessary. Human embryonic stem cell research is completely legal today in the private sector. Embryonic stem cell research is eligible for State funding in several States, California and New Jersey, and is funded through millions of dollars in private research money, $100 million alone at Harvard University.

Since August 2001, 128 stem cell lines have been created. And still human embryonic stem cell research is funded by the Federal Government today. The National Institute of Health spent $24 million on embryonic stem cell research in fiscal year 2004, the last year that data was available. Twenty-two human embryonic stem cell lines are currently receiving Federal funding. These lines are sufficient for basic research according to the NIH director. Former Secretary of Health and Human Services Tommy Thompson has said that these lines should be exhausted first before we move any further.

Finally, embryonic stem cell research remains unproven. Not a single therapy has been developed from embryonic stem cell research. Instead of cures, embryonic stem cell research has led to tumors and deaths in animal studies. The gentleman from Florida (Mr. Weldon) has had his staff scour the medical journals for real proof of therapeutic benefit of embryonic stem cell research, but has come up empty handed. There have been zero published treatments in human patients using embryonic stem cells.

While the promise of embryonic stem cells is questionable, the promise of adult stem cell research is being realized today. Adult stem cells are being used today to save lives. Recognizing this, the National Institutes of Health spent $568 million in fiscal year 2006 on adult stem cell research. Adult stem cells are being used today in clinical trials and in clinical practice to treat 58 diseases, including Parkinson's, spinal cord injury, juvenile diabetes, brain cancer, breast cancer, lymphoma, heart damage, rheumatoid arthritis, juvenile arthritis, stroke, and sickle cell anemia.

I am pleased the House is passing legislation today, the Stem Cell Therapeutic and Research Act, to promote adult stem cell research. But we are faced now with a bill that is unethical and incomplete. H.R. 810 says nothing about human cloning, which is still perfectly legal today. I introduced legislation with the gentleman from Florida (Mr. Weldon) and Senators Brownback and Landrieu to ban all human cloning. The inevitable truth is that if we pass this bill today, the cloning of a human baby will only come sooner. There is no room for shades of gray on this issue. The, quote, therapeutic cloning that will result from this legislation will make reproductive cloning even more likely.

We should not allow the creation of life for the purpose of destroying it. That is what happens with this bill.

Let me be clear. I am committed to funding scientific research that will unlock the origins of disease and develop cures that can help my constituents. Again, 58 conditions are being treated using placental and adult stem cells, and we cannot begin to imagine the promising new treatments and drugs on the horizon. But we cannot let

science leapfrog our ethics, our morals and our legal system. This is not a partisan issue, and it is bigger than a right-to-life issue.

It is clear that adult stem cell research has opened the door to the dreams of lifesaving treatments and cures for our most deadly and debilitating diseases, but I do not believe it is time to open the door to more embryonic stem cell research and open the floodgates to human cloning.

I urge my colleagues to vote against H.R. 810.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 6 minutes to the gentlewoman from Ohio (Ms. Kaptur).

Mr. Speaker, I yield 1 minute to the gentleman from Maryland.