[Congressional Record (Bound Edition), Volume 152 (2006), Part 2]
[House]
[Pages 2234-2241]
[From the U.S. Government Publishing Office, www.gpo.gov]




                      EMBRYONIC STEM CELL RESEARCH

  The SPEAKER pro tempore. Under the Speaker's announced policy of 
January 4, 2005, the gentleman from Maryland (Mr. Bartlett) is 
recognized for 60 minutes as the designee of the majority leader.
  Mr. BARTLETT of Maryland. 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.

[[Page 2235]]

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.

                              {time}  2045

  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

[[Page 2236]]

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?
  Mr. GINGREY. 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.

                              {time}  2100

  Mr. BARTLETT of Maryland. 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?
  Mr. GINGREY. 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

[[Page 2237]]

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.
  Mr. BARTLETT of Maryland. 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

[[Page 2238]]

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.

                              {time}  2115

  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

[[Page 2239]]

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.

                              {time}  2130

  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

[[Page 2240]]

     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.


                               ENDORSERS

       Institutional affiliations are provided for purposes of 
     identification only and do not necessarily represent the 
     views of organizations with which endorsers are affiliated. 
     Endorsers who are not themselves specialists in biomedical 
     science do not put themselves forward as experts in that 
     field. Their endorsement of the proposal pertains to the 
     ethics of ANT-OAR, assuming its technical feasibility.
       Hadley Arkes, Ph.D., Edward N. Ney Professor of 
     Jurisprudence and American Institutions, Amherst College, 
     Amherst, Massachusetts.
       Rev. Nicanor Pier Giorgio Austriaco, O.P., Ph.D., Assistant 
     Professor of Biology, Providence College, Providence, Rhode 
     Island.
       Rev. Thomas Berg, L.C., Ph.D., Executive Director, The 
     Westchester Institute for Ethics and the Human Person, 
     Thornwood, New York.
       E. Christian Brugger, D. Phil., Assistant Professor of 
     Theology, Institute for Psychological Sciences, Arlington, 
     Virginia.
       Nigel M. de S. Cameron, Ph.D., President, Institute on 
     Biotechnology and the Human Future, Research Professor of 
     Bioethics, Chicago-Kent College of Law, Illinois Institute of 
     Technology, Chicago, Illinois.
       Joseph Capizzi, Ph.D., Catholic University of America, 
     Fellow, Culture of Life Foundation, Washington, D.C.
       Maureen L. Condic, Ph.D., Associate Professor of 
     Neurobiology, University of Utah, School of Medicine, Salt 
     Lake City, Utah.
       Samuel B. Condic, M.A., Department of Social Sciences, 
     University of Houston--Downtown, Houston, Texas.
       Rev. Kevin T. FitzGerald, S.J., Ph.D., Dr. David P. Lauler 
     Chair in Catholic Health Care Ethics, Center for Clinical 
     Bioethics Research, Associate Professor Department of 
     Oncology, Georgetown University Medical Center, Washington, 
     D.C.
       Rev. Kevin Flannery, S.J., D.Phil., Dean of the Philosophy 
     Faculty, Pontifical Gregorian University, Rome, Italy.
       Edward J. Furton, Ph.D., Ethicist, The National Catholic 
     Bioethics Center, Philadelphia, Pennsylvania.
       Robert P. George, J.D., D.Phil., McCormick Professor of 
     Jurisprudence, Princeton University, Princeton, New Jersey.
       Timothy George, Th.D., Dean, Beeson Divinity School, 
     Samford University, Birmingham, Alabama.
       Alfonso Gomez-Lobo, Dr. phil., Ryan Professor of 
     Metaphysics and Moral Philosophy, Georgetown University, 
     Washington, D.C.
       Germain Grisez, Ph.D., Flynn Professor of Christian Ethics, 
     Mount Saint Mary's University, Emmitsburg, Maryland.
       Markus Grompe, M.D., Director, Oregon Stem Cell Center, 
     Portland, Oregon.
       John M. Haas, Ph.D., President, The National Catholic 
     Bioethics Center, Philadelphia, Pennsylvania.
       Robert Hamerton-Kelly, Th.D., Dean of the Chapel (Retired), 
     Stanford University, Palo Alto, California.
       John Collins Harvey, M.D., Ph.D., Senior Research Scholar 
     and Professor Emeritus of Medicine, Center for Clinical 
     Bioethics, Georgetown University Medical Center, Washington, 
     D.C.
       Paul J. Hoehner, M.D., M.A., FAHA, Harvey Fellow in 
     Theology, Ethics and Culture, The University of Virginia 
     Graduate School of Arts and Sciences, Associate Professor of 
     Anesthesiology, The University of Virginia Health Sciences 
     Center, Charlottesville, Virginia.
       William B. Hurlbut, M.D., Consulting Professor in the 
     Program in Human Biology, Stanford University, Palo Alto, 
     California.
       John F. Kilner, Ph.D., President, The Center for Bioethics 
     and Human Dignity, 2065 Half Day Road, Bannockburn, Illinois.
       Patrick Lee, Ph.D., Professor of Philosophy, Franciscan 
     University of Steubenville, Steubenville, Ohio.
       William E. May, Ph.D., Michael J. McGivney Professor of 
     Moral Theology, John Paul II Institute for Studies on 
     Marriage and Family at The Catholic University of America, 
     Washington, D.C.
       Rev. Gonzalo Miranda, L.C., Ph.L., S.T.D., Dean of 
     Bioethics, Regina Apostolorum Pontifical Athenaeum, Rome, 
     Italy.
       C. Ben Mitchell, Ph.D., Associate Professor of Bioethics & 
     Contemporary Culture, Trinity International University, 
     Bannockburn, Illinois.
       Most Reverend John J. Myers, J.C.D., D.D., Roman Catholic 
     Archbishop of Newark, New Jersey.
       Chris Oleson, Ph.D., Associate Professor of Philosophy, 
     Center for Higher Studies, Thornwood, New York.
       Rev. Tad Pacholczyk, Ph.D., Director of Education, The 
     National Catholic Bioethics Center, Philadelphia, 
     Pennsylvania.
       Rev. Peter F. Ryan, S.J., S.T.D., Associate Professor of 
     Moral Theology, Mount St. Mary's University, Emmitsburg, 
     Maryland.
       William L. Saunders, J.D., Senior Fellow and Director, The 
     Center for Human Life & Bioethics, The Family Research 
     Council, Washington, DC.
       David Stevens, M.D., M.A., Executive Director, Christian 
     Medical & Dental Associations, Bristol, Tennessee.
       Rev. Msgr. Stuart W. Swetland, S.T.D., Director, The Newman 
     Foundation, Adjunct Associate Professor, University of 
     Illinois at Urbana-Champaign, Urbana, Illinois.
       M. Edward Whelan III, J.D., President, Ethics and Public 
     Policy Center, Washington, DC.
       Rev. Thomas Williams, L.C., Ph.L., S.T.D., Dean of 
     Theology, Regina Apostolorum Pontifical Athenaeum, Rome, 
     Italy.
                                  ____


    Researchers Offer Proof-of-Concept for Altered Nuclear Transfer

       Cambridge, MA, Oct. 17, 2005.--Scientists at Whitehead 
     Institute for Biomedical Research have successfully 
     demonstrated that a theoretical--and controversial--technique 
     for generating embryonic stem cells is indeed possible, at 
     least in mice.
       The theory, called altered nuclear transfer (ANT), proposes 
     that researchers first create genetically altered embryos 
     that are unable to implant in a uterus, and then extract stem 
     cells from these embryos. Because the

[[Page 2241]]

     embryos cannot implant, they are by definition not 
     ``potential'' human lives. Some suggest that this would quell 
     the protests of critics who claim that embryonic stem cell 
     research necessitates the destruction of human life. 
     Scientists and ethicists have debated the merits of this 
     approach, but so far it has not been achieved.
       ``The purpose of our study was to provide a scientific 
     basis for the ethical debate,'' says Whitehead Member Rudolf 
     Jaenisch, lead author on the paper that will be published in 
     the October 16 online edition of the journal Nature. ``Our 
     work is the first proof-of-principle study to show that 
     altered nuclear transfer not only works but is extremely 
     efficient.''
       First proposed by William Hurlbut, Stanford University 
     professor and member of the President's Council on Bioethics, 
     ANT has been described as an ethical alternative to somatic 
     cell nuclear transfer (SCNT), also known as therapeutic 
     cloning.
       For SCNT, a donor nucleus, for example one taken from a 
     skin cell, is implanted into a donor egg cell from which the 
     nucleus had been removed. This egg cell is then tricked into 
     thinking it has been fertilized. That causes it to grow into 
     a blastocyst--a mass of about 100 cells--from which stem 
     cells are removed. These embryonic stem cells can divide and 
     replicate themselves indefinitely, and they can also form any 
     type of tissue in the human body. However, to cull these stem 
     cells, the blastocyst must be destroyed, which some critics 
     insist is tantamount to destroying a human life.
       The procedure theorized by Hurlbut is similar to SCNT, but 
     with one crucial twist: Before the donor nucleus is 
     transferred into the egg cell, its DNA is altered so that the 
     resulting blastocyst has no chance of ever becoming a viable 
     embryo. As a result, a ``potential human being'' is not 
     destroyed once stem cells have been extracted.
       Jaenisch--a firm supporter of all forms of human embryonic 
     stem cell research--has shown that technical concerns about 
     this approach can be overcome.
       Jaenisch and Alexander Meissner, a graduate student in his 
     lab, focused on a gene called Cdx2, which enables an embryo 
     to grow a placenta. In order to create a blastocyst that 
     cannot implant in a uterus, the researchers disabled Cdx2 in 
     mouse cells.
       They accomplished this with a technique called RNA 
     interference, or RNAi. Here, short interfering RNA (siRNA) 
     molecules are designed to target an individual gene and 
     disrupt its ability to produce protein. In effect, the gene 
     is shut off. Jaenisch and Meissner designed a particular form 
     of siRNA that shut off this gene in the donor nucleus and 
     then incorporated itself into all the cells comprising the 
     blastocyst. As a result, all of the resulting mouse 
     blastocysts were incapable of implantation.
       However, once the stem cells had been extracted from the 
     blastocysts, Cdx2 was still disabled in each of these new 
     cells, something that needed to be repaired in order for 
     these cells to be useful. To correct this, Meissner deleted 
     the siRNA molecule by transferring a plasmid into each cell. 
     (A plasmid is a unit of DNA that can replicate in a cell 
     apart from the nucleus. Plasmids are usually found in 
     bacteria, and they are a staple for recombinant DNA 
     techniques.) The stem cells resulting from this procedure 
     proved to be just as robust and versatile as stem cells 
     procured in the more traditional fashion.
       ``The success of this procedure in no way precludes the 
     need to pursue all forms of human embryonic stem cell 
     research,'' says Jaenisch, who is also a professor of biology 
     at MIT. ``Human embryonic stem cells are extraordinarily 
     complicated. If we are ever to realize their therapeutic 
     potential, we must use all known tools and techniques in 
     order to explore the mechanisms that give these cells such 
     startling characteristics. ``
       ANT, Jaenisch emphasizes, is a modification, but not an 
     alternative, to nuclear transfer, since the approach requires 
     additional manipulations of the donor cells. He hopes that 
     this modification may help resolve some of the issues 
     surrounding work with embryonic stem cells and allow federal 
     funding.
       This research was supported by the National Institutes of 
     Health/National Cancer Institute.

                          ____________________