[Congressional Record Volume 153, Number 58 (Wednesday, April 11, 2007)]
[Senate]
[Pages S4337-S4371]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
HOPE OFFERED THROUGH PRINCIPLED AND ETHICAL STEM CELL RESEARCH ACT--
Continued
Mr. ISAKSON. Mr. President, I suggest the absence of a quorum and ask
that the time that runs count equally against both sides for the
remainder of the debate.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent the order for the
quorum call be rescinded.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. HARKIN. Mr. President, I ask unanimous consent that Senator
Stevens be added as a cosponsor of S. 5.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. HARKIN. I suggest the absence of a quorum.
The ACTING PRESIDENT pro tempore. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. BROWNBACK. Mr. President, I ask unanimous consent the order for
the quorum call be rescinded.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. BROWNBACK. I believe under the previous agreement I have 30
minutes at this time, may I inquire of the Chair?
The ACTING PRESIDENT pro tempore. Approximately 30 minutes--44
minutes, the Senator has.
Mr. BROWNBACK. I want to introduce to the body, into the discussion,
a gentleman I had a chance to meet who came in front of a Senate
Commerce, Science and Transportation Subcommittee--Keone Penn. I have a
picture of this young man here. I want to share his story. He was cured
of sickle cell anemia. We use that term advisedly, but clearly, cured
of sickle cell anemia through cord blood adult stem cell treatment--
cured.
I want to do part of this to encourage other people out there who
might by chance be listening or know somebody else who has sickle cell
anemia who has not yet been able to get treated; to talk about cures
using cord blood. We have cord blood banking. That is taking place.
Cord blood is the blood between the mother and the child when the child
is in the womb, and the use of it, which we have now banked--10,000
units roughly have been banked and used throughout the country for many
types of illnesses and sicknesses. I want to talk about curing sickle
cell anemia in some cases using cord blood.
Sickle cell anemia is a disease that afflicts more than 70,000
Americans and a disproportionate number of African Americans. Keone
tells the story the best so I will just highlight what he stated in
front of a Senate science subcommittee hearing that I chaired. He said:
My name is Keone Penn. Two days ago I turned 17 years old.
Five years ago they said I wouldn't live to be 17. They said
I'd be dead within 5 years.
[[Page S4338]]
I was born with sickle cell anemia. Sickle cell is a very
bad disease. I had a stroke when I was 5 years old. Things
got even worse after that. My life has been full of pain,
crises, blood transfusions every 2 weeks, and more times in
the hospital than I can count.
The year before I had my stem cell transplant I was in the
hospital 13 times. I never was able to have a normal life. My
stem cell transplant was not easy, but I thank God that I'm
still here. I will graduate from high school and I want to
become a chef because I love to cook. I think I'm pretty good
at it.
Sickle cell is now a part of my past. One year after my
transplant I was pronounced cured. Stem cells saved my life.
Many have heard of Keone's amazing story on previous occasions, and
the effectiveness of cord blood stem cell research for such diseases
rightly gives hope to millions.
Keone's story is yet another of a great litany of adult stem cell
successes.
I want to focus now on the cord blood stem cell successes and why we
should not be directing research dollars down other paths, such as
embryonic stem cell and human cloning that have not produced these
sorts of cures or these sorts of treatments, when we could do a lot
more with treatments in the cord blood field.
As I noted, we started a cord blood banking program. We now have cord
blood banking taking place in several places. I hope people are doing
more of this across the country. As I stated, we have distributed
nearly 10,000 units of this to get to matches in various places, in
various individuals across the country. We need more cord blood donated
because you have to match a series of six factors and at least four of
those factors must match to be able to use the cord blood in a
particular individual such as Keone. Therefore, you need to have a
broad cross-section of cord blood in the banking supply so people can
possibly find a match.
In many places it has been used as a substitute for bone marrow and
the difficult collection process that takes place sometimes with
marrow. We need more in the cord blood field so we can get more people
treated like Keone Penn. I think that is a key avenue for us, in stem
cell work, in producing the results.
Next step, the next field we need to go to is amniotic fluid. I want
to show this to my colleagues. Some of them would have seen this issue.
We started a cord blood banking program to get this, so we could get
more matches across the country and could get a broader cross-section
of individuals who have contributed from various types of blood so we
could get matches.
The next area we need to bank in, I believe, is amniotic fluid. The
fluid that surrounds the child as the child is in the womb is also a
rich source of stem cells. It would be my hope that in this year's
appropriations bill we would not only study, I hope we will begin the
collection and funding of collecting amniotic fluid.
Now I urge my colleagues on all sides of this issue to say: Here is
another one we can agree upon in moving forward in the stem cell field.
I wanted to cite to this, because it is an exciting breakthrough of
news.
This article appeared in JAMA, Journal of American Medical
Association, February 28 of this year, on amniotic fluid. Amniotic
fluid-derived stem cells can be coaxed to become muscle, bone, fat,
blood vessels, nerves, and liver cells. It might be capable of
repairing damaged tissue resulting from conditions such as spinal cord
injuries, diabetes, Alzheimer's disease, and stroke.
My reason for pointing this out is this is one we can agree upon.
This is one we can move forward with. The amniotic fluid is discarded
after the pregnancy, is not collected. It can be collected. It could be
collected. We should see about collecting this and move forward on
these treatments, and some of the $613 million we spent on embryonic
stem cell research could go into this field, and likely you are going
to be producing results very quickly. If the amniotic fluid some people
are talking about, as well as the placenta, being able to collect stem
cells from the placenta and other rich sources of stem cells--if we can
take some of this $613 million that has produced zero human clinical
trials to date and put it into fields that are producing or have a high
potential here in a near-term basis to be able to produce treatments or
possibly even cures--no ethical problem, no ethical issues; this would
be clearly a key one to go forward with.
I also want to further develop the thought about embryonic stem cells
leading inevitably to human cloning. I want to put out some numbers on
this, follow with the discussion on this. People certainly will
understand it. If we are to collect and develop additional embryonic
stem cell lines, we get these embryos from IVF clinics around the
country, and you start these lines, the genetic match will not take
place. That genetic material will not match anybody, because it is
unique genetic material, so as soon as it is implanted into somebody
else, there is going to be a rejection by the body taking place. That
individual is going to have to be on immunosuppressive drugs for the
remainder of their life, because the body is rejecting this foreign
material.
Therefore, the answer is to move forward, saying, well, okay, we have
developed this science, we can do human embryonic stem cell work, it
works, but we are getting the rejection taking place. Therefore, we are
going to need to do human cloning, but it is not going to be real human
cloning, it is going to be SCNT--somatic cell nuclear transfer, that is
the scientific name for human cloning--and we are not going to clone,
because we will create the clone, we will harvest women's eggs, we will
then create the clone, and we are not going to allow the implementation
of it. Therefore, we can say it is not cloning because it is not going
to result in a full-scale child, by all definitions. We are going to
clone a person, we are going to start human life, then we are going to
purposefully kill it for its stem cells, that genetic match.
That is the process this will inevitably lead to if we are successful
in this science that I believe highly doubtful, given the tumor
formation. But let's say we are successful in the next couple of
decades, we can develop the science, the tumor issues somehow we are
able to deal with, over that period of time, we get over that hurdle,
we can develop it.
We have an immunosuppressant problem, so therefore now we have got to
move into human cloning. Where do we get those human clones? We get
them from people. We have to have an egg we get from women. We will get
the genetic material from the person who needs the embryonic stem
cells; that is not a problem. But we are going to have to harvest a lot
of eggs.
I want to go through some of those numbers from different individuals
who have looked and thought about this. I would hope my colleagues,
even if they are on the other side of this, would think about where
does this take us, which is a real question about the idea of doing
massive amounts of human cloning, massive amounts of harvesting of
women's eggs to do human cloning that is going to take place. Because
you do not get a one-for-one match, you get the one human egg, you are
not going to get it to necessarily take as a human clone, it is going
to take a number of attempts to take place--I believe the numbers I
have heard are somewhere around 200 eggs are necessary to get one clone
to take.
Now, maybe we are able to develop that technology better into the
future. But if we develop this line, you are probably going to look at
the need for hundreds of thousands, if not millions, of embryos needed
to pursue this speculative embryonic stem cell research. And for this
application, you are going to need millions of eggs and millions of
human clones--excuse me, I cannot call them clones--SCNT products, that
is the scientific name for human clones, SCNT clones. These embryos are
going to have to be developed that way to obtain sufficient embryos for
this speculative research science, that will turn to human cloning,
which will exploit women for their eggs, because where are we going to
get hundreds of thousands of eggs? Are we going to have women in this
country be willing to voluntarily go through the process, a difficult
process? It can be damaging to their bodies.
Maybe we will get some to do that. Probably more likely we will be
going abroad to recruit people to give eggs. It is unlikely they will
give them, it is more likely they will be paid for those eggs to take
place, and to go through this difficult, painful, and potentially
harmful problem.
Is that the route we want to go, or would we be wiser to work with
amniotic fluid, the cord blood, the placenta collection that is taking
place,
[[Page S4339]]
and take some of this money and develop that field? I think the route
forward is pretty clear.
I also want to discuss the idea we were talking about, a disposable
medical infrastructure, the frozen embryos. I want to put back up a
chart of one of those embryos we have here, and talk about this from a
standpoint. I ask my colleagues to think about this for a second.
I believe everybody is wrestling with the notion that the human
embryo is alive. We all agree it is alive. Some of us will give it the
status of a life; others would not. Others would call it a potential
for human life. I do not believe that is the scientific term, but some
would call it a potential for human life.
It is a human embryo. Here is a picture of a human embryo. That is
actually a child who was adopted as a frozen embryo and implanted and
grew. This is, of course, what we are looking at as a physical entity.
It is human. It is in the human species. We know that. All of us are
having some level of difficulty with using taxpayer funding to destroy
that young human life. Well, why are we having that level of difficulty
with destroying something that looks like this? I think it is because
in our own being, and the natural law that resides in each of us, we
believe in dignity for every human being, period. We believe everybody
who is here, who is listening or watching this, is a dignified person
and worthy of respect and worthy of recognition as a person. That is
why when we have people on death row and facing execution, we do not
say, let's go and harvest their organs. When we hear that term, we are
appalled by it, because we are saying: That is wrong.
Well, why? Because the person is going to die. They were convicted of
a heinous crime. Why not harvest their body parts and save some lives?
Because we certainly could. That way we could save a number of lives by
harvesting the organs of a person who committed a terrible crime. They
are guilty. Despite the number of people having difficulty with the
death penalty--and I have difficulty with the death penalty--why
wouldn't we go ahead and harvest the organs? We are going to throw them
away, right? We are going to dispose of them, right?
Well, but something within us says, that doesn't feel right; that
seems as if that is the wrong thing to do. And it doesn't seem as if it
is right because it is not the right thing to do. It violates their
human dignity, that individual, even though they have committed that
crime, is a dignified human being and worthy still, even though they
have committed the heinous crime, is worthy of us treating them with
some level of respect, and not harvesting their organs. If they decide
to voluntarily give them up, that is their choice, but they are worthy
of that respect. So why, when we are looking at human life here, that
all of us agree is human, alive, would we say: Well, callously, we can
throw them away because they do not look like us.
Well, the child at this stage starts to look like us, but it is
pretty small. You can say it doesn't look much like us. Can we do it at
that stage too? Then if we are uncomfortable with doing it in the early
phase, or we are comfortable with doing it in an earlier phase, or when
Hannah is born, can we research on her then? She cannot do a whole lot
at that point in time for herself. If we leave her by herself, she will
die. She can't care for herself at that point in time. So why not
research on her at that point? Well, no, because she is a dignified
human. So, okay, she is here. At what point? Here? Probably so. At that
point? Here?
Well, I don't think so. I agree she is human. I agree she is alive,
but I am not willing to give her any dignity status as a human.
What divides those? Some would say place, placement. If it is placed
in a womb, it is. If it is not in the womb, it is not. Location has not
determined personhood in our past. I would suggest it doesn't determine
it in our future or presently. There is a natural revulsion toward this
idea that we would take life from somebody for their body parts for
somebody else, and here we are having difficulty saying, well, yes, but
the possibilities are so promising we are going to go ahead and do it
anyway.
I quarrel with the possibilities being that promising, and I have
gone through this at length with my colleagues and discussed that. Even
if it were, what about the human dignity of each of us? When we have an
alternative that is working, and when we have more possibilities we can
fund in the amniotic fluid developing, and the placenta research, why
not go those avenues, where we are actually getting some possibilities,
we are actually getting people treated, and we have no ethical
questions, and we can go forward aggressively and happily about it?
I am pro-life and whole life. I believe life is sacred. I believe
life is sacred in the womb and I believe life is sacred wherever it is.
I believe a child in Darfur is sacred, I believe that person even on
death row is sacred, and should be treated with dignity. I believe the
youngest phase that people are is sacred and should be treated with
dignity. I do not think we have to go there. And if we do go there, it
leads down a path we do not want to follow in human cloning, and that
we should agree with as a society.
Mr. President, I want to also note to my colleagues we can spend a
lot of time on this bill. I do not believe it is going to become law
because of the divide in this country, because the President is going
to veto it. We will see if there are votes to sustain that veto or to
override that veto. I do not think this is going to become law. So why
would not we then look at this as a chance for us to work together on
areas that we know have high potential for cures and treatment and that
unite us? There are plenty of things that divide us. There are clearly
things in areas that unite us, there are clearly future areas of things
that we can work on to unite us and to provide cures. Why would that
not be a better approach? Are we so locked into a division here that we
cannot find a way forward? I would submit we can find a way forward,
and that we can work on these topics and provide cures so none of us is
the poorer for it. We are moving forward. Unfortunately, too much of
the work is happening overseas in the adult stem cell work and our
people are not getting good access to it. I have cited several
examples--that should not be happening overseas; it should be readily
available here--of treatments that are developed here but are actually
being practiced in places overseas because of either lack of interest
or support that we would have here. I urge my colleagues to vote
against S. 5. I urge my colleagues to work with me and others on
developing this promising field in amniotic fluid. I urge others to
work with me as we work in the areas of adult stem cell and cord blood
that are currently treating and curing people and that we can do more
of that and we can do that together and happily together and unite our
country on an important topic instead of constantly dividing.
I yield the floor.
The ACTING PRESIDENT pro tempore. The Senator from Michigan.
Mr. LEVIN. Mr. President, are we operating under a UC at the moment?
The ACTING PRESIDENT pro tempore. We are operating under consented
time. The Senator from Iowa controls 90 minutes.
Mr. LEVIN. I have been authorized to yield myself 10 minutes.
The ACTING PRESIDENT pro tempore. The Senator is recognized.
Mr. LEVIN. Mr. President, in the previous Congress, the Senate and
the House of Representatives voted resoundingly to lift the President's
burdensome restrictions on embryonic stem cell research. The President,
however, used the first--and so far only--veto of his administration to
reject this potentially life-giving research which is supported by a
clear majority of the American people. We are here today to try again
to give our scientists the tools they need as they work to cure some of
the most debilitating and dreaded diseases. We will not--and we should
not--yield until we remove the obstacles the President has put in their
way.
This fight is critical, because embryonic stem cell research could
hold the key to curing diseases that no other research could cure. As
best we know now, an embryonic stem cell is unique in nature. It alone
can develop into any other type of cell in the body. Embryonic stem
cells--and embryonic stem cells alone--can become a nerve cell, a
muscle cell, or any of the more than
[[Page S4340]]
200 types of cells in the body. The promise of this unique ability is
clear: If scientists could replace diseased cells with healthy cells
created from embryonic stem cells, it could save an untold number of
lives.
For example, Parkinson's disease is a motor system disorder that
results from a loss of brain cells that produce dopamine. Individuals
with Parkinson's disease often experience a trembling in the hands,
arms, or face, and impaired balance and coordination. As the disease
develops, it can become difficult to walk, talk, and complete other
basic tasks. With research, scientists may be able to coax embryonic
stem cells into becoming healthy neurons that produce the desperately-
needed dopamine. If those neurons can be successfully transplanted into
a patient with Parkinson's disease, that person could be cured.
The list of diseases that could benefit from stem cell research is
long--Alzheimer's disease, Lou Gehrig's disease, juvenile diabetes,
spinal cord injuries, and many others. Stem cell research could offer
the millions of Americans suffering from these diseases not just hope
but cures.
Supporters of stem cell research understand that these breakthroughs
will not be easy or inevitable. But the President's policy makes them
far less likely. On August 21, 2001, President Bush issued an executive
order that the Federal Government would only fund embryonic stem cell
research on stem cell lines created before that date. ``Stem cell
line'' is the name given to constantly-dividing cells that continue to
be derived from a single embryo.
Most independent experts estimated at the time of the President's
executive order that about 80 stem cell lines--a woefully inadequate
amount--would be available for Federal research. Most of those lines
were later determined to be polluted and unusable, leaving only about
20 stem cell lines available.
Last month, the Director of the National Institutes of Health, Dr.
Elias Zerhouni was asked during testimony before the Senate
Appropriations Subcommittee on Labor, Health and Human Services, and
Education whether ``scientists have a better chance of finding new
cures [and] new interventions for diseases if the current restriction
on embryonic stem cell research were lifted.'' Dr. Zerhouni responded:
``these cell lines will not be sufficient to do all the research we
need to do . . . these cell lines have exhibited instability from the
genetic standpoint and it's not possible for me to see how we can
continue the momentum of science in stem cell research with the cell
lines that we have currently at NIH that can be funded. It is clear
today that American science would be better served and the nation would
be better served if we let our scientists have access to more cell
lines.''
In issuing his executive order and in vetoing the bill we passed last
year, the President did not question the scientific possibilities of
stem cell research. In fact, he said the opposite. He stated in 2001:
Scientists believe further research using stem cells offers
great promise that could help improve the lives of those who
suffer from many terrible diseases.
The President's objection is to using embryos for research. But the
key fact--and one that opponents refuse to deal with--is that any
embryo not used for stem cell research is going to be destroyed anyway.
The embryos created by fertilization clinics that are not going to be
used for implantation will be destroyed. Why not give them a life-
giving use then? No answer has been forthcoming from the President.
RAND Health conducted a study in 2003 that found there were
approximately 400,000 embryos in storage in the United States and some
of these embryos will never be used because parents either had a
successful pregnancy and no longer need them or because treatments were
unsuccessful. In addition, the study found that only 2 percent of these
embryos will be used to create pregnancies in unrelated mothers. Many
will be discarded.
Last year, the Detroit News editorialized against a Michigan law
restricting embryonic stem cell research and used words that apply
equally well to the President's policy. The News wrote:
The justification for this law is to protect human embryos,
but the fact that fertility clinics can simply discard them
means that the research ban is pointless.
Sean Morrison, director of the University of Michigan's Center for
Stem Cell Biology and one of the country's leading stem cell
researchers, agrees. In an article in the Ann Arbor News last month,
Dr. Morrison stated:
The thing about that that's crazy is human embryos are
discarded all the time by fertility clinics . . .So it's
legal to throw them away, but it's not legal to use them to
try to help somebody.
Embryonic stem cell research is truly a life-giving process because
of the extraordinary potential for healing living, breathing human
beings, human beings with names and faces and families.
Members of the House of Representatives have now passed the
bipartisan Stem Cell Research and Enhancement Act, H.R. 3. After we
debate the companion bill, S. 5, I hope we too will again adopt it and
remove the President's arbitrary prohibition against funding stem cell
research on embryos. It will pave the way for hundreds or thousands of
additional stem cell lines to be made available.
This bill has the strong support of the American Medical Association,
the Coalition for the Advancement of Medical Research, the Association
of American Universities, the Christopher Reeve Foundation, the
Juvenile Diabetes Research Foundation, the Leukemia and Lymphoma
Society, the Parkinson's Action Network, and more than 500 additional
organizations. More importantly, it has the overwhelming support of the
American people. If the President again vetoes this bill, I hope
Congress will override that veto.
As part of the unanimous consent agreement to consider this
legislation, we are considering an additional bill as well. Senators
Coleman and Isakson introduced a bill that promotes stem cell research
limited to those stem cells obtained from ``naturally dead'' embryos.
These embryos are called ``naturally dead'' because they are unable to
divide and reproduce like other embryos. While we should pursue all
types of research, I do not believe we should limit stem cell research
to stem cells that may be flawed, as indicated by their inability to
reproduce and divide.
Embryonic stem cell research holds enormous promise for healing and
saving individuals who suffer from debilitating diseases and injuries.
It is our responsibility to pursue those cures and treatments in an
ethical manner. In order for our scientists to do quality research and
make advances in medicine, they must have access to embryonic stem
cells that are uncontaminated and viable for research, especially since
they will otherwise be destroyed. S. 5 will allow our scientists to
move forward to a new generation of potentially life-saving cures. It
deserves the support of this body.
I yield the floor.
Mr. BINGAMAN. Mr. President, I yield myself 5 minutes from the time
reserved on Senator Harkin's side.
The ACTING PRESIDENT pro tempore. Without objection, the Senator is
recognized for 5 minutes.
Mr. BINGAMAN. Mr. President, I rise in favor of S. 5, the stem cell
enhancement bill of 2007. Many of my colleagues have eloquently stated
reasons for supporting this bill over the past 2 days. The passage of
this bill would be an important step forward for research into
treatments of devastating diseases. In addition, passing S. 5 will help
the United States as a leader in biomedical research, a leader in
transparent and ethical research practices, and a leader in developing
safe, effective treatments for diseases. I wish to see stem cell
therapies developed in this country so we can ensure the safety and
availability of these treatments for American families and at the same
time create jobs for highly skilled workers to do the necessary
research and to develop these new treatments.
Our current policy puts us at a severe disadvantage to other
countries. As the Director of the NIH said at a recent hearing, our
current stem cell policy is akin to working with one hand tied behind
our backs. Scientists in most other countries are at an advantage to
U.S. scientists because they are allowed to study the best stem cell
lines and do so with government funding.
Let me explain this world stem cell policies map I have put up. It is
color coded to show the different stem cell policies that exist in
different parts of
[[Page S4341]]
the world. We have essentially chosen four colors or four categories of
policies I am trying to focus on. First, we have the countries in
yellow which have not adopted stem cell policies. You can see those
countries are fairly extensive. Next to those are those that have
adopted stem cell policies. The United States is part of that group.
Those are the countries in gray on this world map. The United States is
among the most restrictive of those countries that are in gray, but we
do have other countries that have policies that are in that category as
well.
Third are the countries in light brown which allow the creation of
stem cell lines from leftover embryos in IVF clinics. We can see those
light-brown countries. Passing S. 5 would move the United States into
that group of countries, such as France and Canada and Brazil.
The final group depicted on this world map is those that are shaded
in dark brown. These countries allow other laboratory techniques to be
used to create embryonic stem cell lines. You will notice that many of
these countries have very strong scientific research programs. I
particularly mention the United Kingdom, India, and China as part of
that. Scientists in these countries, other than the United States, are
free to use the type of stem cells best suited to their research,
whether they are adult stem cells or embryonic stem cells created
before 2001 or embryonic stem cells created after 2001. In fact, many
countries have been promoting stem cell research because they see this
as an opportunity to get ahead in this field during a time when U.S.
scientists are restricted to less useful stem cell lines.
For example, the United Kingdom has established a world stem cell
bank to collect, characterize, and distribute embryonic stem cell lines
to researchers around the world. The United Kingdom has also developed
a comprehensive national regulatory system that requires researchers to
follow strict ethical guidelines. While these regulations may slow
research to some extent, embryonic research is an area that merits
extra care and transparency and oversight. We should not relinquish our
duty to uphold high ethical research standards to other countries or to
individual States within this country or to the market more generally.
I ask unanimous consent for an additional 2 minutes.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered. The Senator is recognized.
Mr. BINGAMAN. Many other countries, including Singapore, Korea, and
Australia, also have federally funded centers for embryonic stem cells.
However, it will be difficult for the United States to capitalize on
the research advances that are made in these other countries since
federally funded scientists in the United States are restricted from
collaborating with foreign scientists who use the stem cell lines that
were generated after 2001.
Furthermore, we can't leave this important field of science to the
private sector alone. We have a long history of bipartisan support for
basic science research in this country precisely because it does not
make financial sense for industries to invest substantially in early-
stage research. Any scientist will tell you that human embryonic stem
cell research is still in its early stages, and that it has gone more
slowly than it would have otherwise gone because of the restrictions
currently in place in our own policy. Furthermore, most cell-based
therapies, including bone marrow stem cell transplants, were first
developed in academic research hospitals and have never been widely
utilized. This means Federal funding is even more important for cell-
based therapies such as stem cell transplants than it is for other
types of treatments.
Mr. President, I urge my colleagues to support S. 5. It is an
important step to keep the United States a world leader in the field of
biomedical research, and it will give hope to many of our citizens for
the treatments they desperately need.
Mr. President, I yield the floor.
The PRESIDING OFFICER (Mr. Sanders). The Senator from Maryland.
Ms. MIKULSKI. Mr. President, I rise today to speak with some great
urgency on the need to pass the Stem Cell Research Enhancement Act of
2007, S. 5.
We must pass this bill because if we do not, the American people will
continue to suffer, our brilliant researchers will be discouraged and
think about leaving the field of scientific research and, No. 3, we are
also outsourcing our intellectual capital because other research is
going overseas.
We have to have a sense of urgency because stem cell research takes a
long time. We cannot have science on demand or scientists on demand. If
we do not act now, we are going to be discouraging very important
research and wonderful young people from going into this field.
Every year we wait, we fall 3 years behind in our research--another
time where a patient might have been saved, a family might not have had
to watch a loved one suffer, and also where we would not have to watch
our great ideas going somewhere else.
Stem cell research is very important to the American people. It is
very important to Maryland. It is very important to me. I am a firm,
clear, unabashed supporter of expanded stem cell research and, at the
same time, that this research be conducted under the strictest
bioethical standards. That is why I like S. 5. This legislation is
based on sound cellular biology science and also good, sound ethical
principles.
This legislation is so important not because legislation is important
but because it opens more opportunity to do stem cell research. What
does that mean? It means that currently the existing law under
President Bush restricts stem cell research to adult cells, to some
vague 21 lines that are becoming tired and toxic. But under our
legislation, it would open it up to embryonic stem cell research where
embryos are garnered that are discarded in in vitro processes in which
the donors themselves have to make that informed choice.
What does this do, though? Well, I will tell you, stem cell research
is the kind of research that could find a cure for Parkinson's disease,
diabetes, diseases of the brain and the immune system, multiple
sclerosis, and spinal cord injury. Imagine if scientists could find a
cure for Alzheimer's or Parkinson's, or if they cannot find a cure, to
be able to regenerate new kinds of brain cells to give people a
cognitive or functioning stretchout. Think about the impact on
families, but also think about the impact on our nursing home budget.
Think about research in juvenile diabetes, type 1 diabetes, where
little children, every day--whether they are 5 or 9 or 11--have to be
testing their blood sugar. They cannot eat the way other kids do. They
have to watch how they pace themselves when they play ball or do other
things so they do not induce hypoglycemia. As they get older and their
cells get even more tired, they fear they could lose a kidney or lose
their eyesight.
If we could find more breakthroughs in juvenile diabetes, we would
give them their childhood back. We would give them a life that has a
future full of promise. That is why we are fighting here. It is not
about ideology. It is not about party. It is about our American people.
And what we invent here could help save lives everywhere.
Yesterday, I went to Johns Hopkins University to discuss this stem
cell research. I wanted to be sure I was on the right track: sound
science, good, solid ethical frameworks. I said to the scientists: Tell
me what you are doing and tell me what impedes you now working under
the Bush framework?
Well, they gave me an earful. First, it is inspirational--
inspirational--in what they are doing in pediatric leukemia, in
juvenile diabetes, in multiple sclerosis. Also, to give an example, in
talking to Dr. Doug Kerr, he is working now through stem cells--yes, it
is with paralyzed rats--to not only regenerate the spinal cord but to
have those cells connect to muscle so not only for whether you are
regenerating spinal cords that have been injured or severed, but also
to connect the muscle so you could walk again. That was the dream of
Christopher Reeve. But that is the dream of every paraplegic right
now--whether it has come from a diving accident, if you are an athlete,
or whether you have been injured in Iraq or Afghanistan.
Don't we want Dr. Kerr to do what he is doing now and to be able to
extend that? But they do not get the clinical
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trials because they are restricted in the types of cells they can use.
So we saw a cornucopia, again, of opportunity there. But I said to
the docs at Hopkins: Why can't we do this with private or State funds?
They said: Senator Mikulski, you have to have a national framework.
First, that is where you get your bioethical guidelines. It is done not
while there is one set of guidelines for States that can afford
research and that there is another set of guidelines for those States
that can't. Also, there is not enough in private philanthropic funds to
be able to do this.
Private funds function like venture capital. But at the same time,
what happens with States? Maryland is now in a bidding war with our $25
million against California. We have scientists who are leaving Maryland
to go to California. Hats off to them. But also, then, we have
scientists in Maryland and California who are leaving the country
because they can do work in Sweden or Singapore that they cannot do in
their own country. These are American scientists who want to do their
own work in their own country. But we are driving them out with our
narrow-minded ideological sense of politicizing science.
So we cannot do this with State funds, and we cannot do it with
private funds. As I said, right now we are outsourcing this to China,
to Singapore, to Australia, to Germany. I am not saying there are good
countries or not good countries, but what are we doing? We are losing
our intellectual capital. We are also losing our young scientists.
Yesterday, I talked to a young doctor. I knew him as a resident. His
wife was a friend of a friend of mine. I knew him through his
residency. Now he is a young doctor, married, with three children. His
whole field is diabetes. He is so eager to do this juvenile diabetic
research. He has already started it. He is already good at it. Gosh,
maybe he could win the Nobel prize one day. But guess what. There is
not the money for the young scientist. Also, with the very shackling of
what goes on now in these so-called Bush lines, with these ideological
guidelines, they cannot do the research. He has to think hard about
whether he wants to continue his life dream of finding a cure for
juvenile diabetes.
You see, this man has devoted his life to getting ready to do this,
and now his own Government is stopping him--not because he is not
smart, not because we do not have the will, but because we have too
much ideology and too little money in the wallet.
We have a President who has given us a framework where research has
one hand behind its back. Scientists have been prohibited from doing
new stem cell research.
Six years ago, the President restricted Federal funds for embryonic
stem cell research. What did it do? It created an unregulated
atmosphere. The result was federally funded stem cell research was
halted almost entirely. Stem cell research was done by private
entities. A private entity has no Federal bioethical standards.
Mr. President, like you, I am a sunshine person. I believe you should
have research conducted in the sunshine. That is where you have
compliance with bioethical standards. That is why we need to have the
kind of national framework where everybody goes by the same rules, at
the same time, in the same way. Without national standards, research
will be done by the well-heeled, outside of the public eye, with no
national scrutiny. This is where I fear dark and ghoulish things can
occur.
I acknowledge the validity of some of the concerns raised by
colleagues. But as long as you shove it underground, as long as you
shove it behind closed doors, then you are going to get either faulty
research or very bad ethics.
I believe the legislation pending will remove the restrictions
imposed by the President. It will provide the ethical and medical
framework we need for federally funded stem cell research. It will
create strong ethical guidelines. Most of all, it will ensure that we
now open the opportunity for even greater and more expanded stem cell
research so scientists will now have access to new, fresh stem cell
lines which they now do not.
What does it mean? Well, I can tell you what it means. It means for
the United States of America we have heard what the voters said in
November. They said: Change the direction of the country. Change the
priorities. Come back home, America. Remember what America is. We are
the land of the free, the home of the brave, and of discovery. Let's go
for it.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, I thank the Senator from Maryland for her
very eloquent statement and for her strong support of hope and health
and healing, as encompassed in S. 5.
Mr. President, while I wait the arrival of our next speaker, I want
to point out that time and time again I hear those who are opposed to
S. 5 use the phrase that they are opposed to funds being used for the
destruction of embryos. Earlier today I had corrected one Senator who
said that. I said: Show me in the bill where it is. Well, then other
Senators--the Senator from Kansas and others--have gotten up and talked
about not using money for the destruction of embryos.
I challenge anyone, any Senator to come and take S. 5 and show me
anywhere in there where there is one dime used for the destruction of
embryos. It is not there. I get the feeling that a misrepresentation
repeated and repeated somehow seems to take hold so that people say:
Well, there must be money for the destruction of embryos in this bill.
There is not. That is covered by the Dickey-Wicker amendment which
pertains to appropriations bills, and I am an appropriator, and that is
covered there. So none of this money is used for the destruction of an
embryo. All it is used for is for the research on stem cells that have
been derived, which is what is being done today, by the way--which are
derived. Now, those derivations can come from private entities or State
sponsored or wherever, maybe some international, maybe foreign
countries--wherever. But none of the money here in our bill, S. 5, can
be used for the destruction of an embryo, period. If anyone says so,
please come and show us where it is in the bill that says that.
Mr. President, I see the distinguished Senator from Missouri is here.
I yield 15 minutes to the Senator from Missouri.
Mrs. McCASKILL. Mr. President, I rise to speak today on a matter of
significant medical, scientific, and personal importance. Today, my
colleagues and I have the opportunity to support research which will
result in lifesaving cures, research which alleviates pain and
suffering, and research which improves the quality of life of millions
of Americans. I am speaking about research which will provide some of
the most significant medical advances we have ever seen in the history
of mankind.
Of course, I am speaking in the strongest support of S. 5, the Stem
Cell Research Enhancement Act. I thank my distinguished colleagues,
Senators Harkin, Hatch, Kennedy, and Specter, for the leadership they
have offered on embryonic stem cell research legislation over the last
several years.
In my short time in the Senate, I have had the occasion to speak and
vote on numerous matters of significant national importance, but not
every day do we have the opportunity to vote to heal the sick. Today,
we have a chance to set aside partisan politics and support legislation
that aims to improve the quality of life for tens of millions of
Americans. It is a noble cause and one that reminds me of how proud I
am to represent Missouri in the Senate.
Who would oppose such a cause, and what would their reasons be for
such opposition? The opponents of embryonic stem cell research attack
it on multiple fronts--public opinion, scientific fact, and moral
grounds--and the war against embryonic stem cell research is fought in
our communities, in the media, and today in this Congress.
Unfortunately, the casualties are the medical researchers and doctors
who want nothing more than to cure diseases. That is all they want.
They have no grand scheme. There is no big money here. We are talking
about curing diseases. Ultimately, the casualties are the patients who
would benefit from those cures.
My greatest disappointment in this debate has been the numerous
inaccurate statements made in this Chamber by opponents of embryonic
stem
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cell research. Because this issue was on the ballot in Missouri last
year, I had the opportunity to learn a great deal about this field
during the months we campaigned for the U.S. Senate, as this issue was
debated in great detail across my State. Let me talk about a few of the
misrepresentations that have been made in this debate.
Claim: Adult stem cell research and stem cells derived from umbilical
cord blood and amniotic fluid are adequate and we don't need embryonic
stem cell research and there are 72 adult stem cell treatments for
human diseases. The truth: In the medical journal Science, July of
2006, Dr. William Neaves of the Stowers Institute for Medical Research
in Kansas City and Dr. Steven Teitelbaum of Washington University
Medical School in St. Louis detail that this false claim originates
from David Prentice of the Family Research Council. Mr. Prentice
asserts that there were over 1,000 ongoing clinical trials of adult
stem cell therapies. A review of the record at the NIH Web site that
tracks clinical trials, however, showed that Mr. Prentice grossly
misinterpreted the data. He searched the database for any entry
containing the word ``stem'' and counted items such as ``brain stem,''
``system,'' and ``stem from,'' which is a verb. There were numerous
other errors and omissions that served as the basis for this claim. In
fact, there are only a handful of clinical trials with adult stem
cells, and only nine conditions have adult stem cell treatments that
are approved by the FDA.
In addition, as the Senator from Iowa so eloquently outlined
yesterday, most scientists and patient advocacy groups agree that adult
stem cell research is not a substitute for embryonic stem cell
research. All research is good, but we cannot substitute an inferior
form of research for the type of research that holds the most promise
for these elusive cures.
Many organs do not have adult stem cells, and adult stem cells and
cord stem cells are not pluripotent. That means they don't have the
ability embryonic stem cells do to develop into any type of cell, and
therefore their use is limited.
Claim: Tumors are a necessary product of implanting embryonic stem
cells. The truth: Tumors will only develop if undifferentiated stem
cells are injected into mice. Undifferentiated cells are those which
have not developed into their final state. For example, a cell that has
not developed into its final state is a blood cell or a bone cell or a
nerve cell. In fact, tumor formation is exactly how scientists
determine that a cell is pluripotent--in other words, able to develop
into a multitude of different types of cells. However, nobody is
suggesting that undifferentiated stem cells be injected into humans.
The FDA has monitored this question, and there is no evidence that
cells differentiated from embryonic stem cells cause tumors.
Claim: The 21 viable embryonic stem cell lines we have currently
funded are plenty. It is sufficient. The truth: As Dr. John Gearhart
told the Committee on Aging, the federally approved lines are not
genetically diverse, meaning we don't have the cell lines needed that
will allow us to fully utilize this vital research. Importantly,
minorities are the greatest affected group due to the lack of genetic
diversity in these cell lines. In addition, many of the federally
approved lines are contaminated with mouse feeder cells. Finally, some
of these cell lines are involved in proprietary arguments and are not
available for research purposes. Asking America's scientists to work
with only 21 viable embryonic stem cell lines is hamstringing them and
impeding this important progress.
Claim: This legislation will use tax dollars to fund destruction of
human embryos. The truth: Each year, Congress attaches the Dickey-
Wicker amendment to the Labor-HHS appropriations bill stating that no
Federal funds can be used to destroy human embryos. That has not
changed. This bill simply allows Federal funds to be used to study stem
cell lines that are derived from human embryos that otherwise would
have been discarded. How many times do we need to say it: ``that
otherwise would have been discarded.'' Not a dime of Federal money will
fund the destruction of human embryos.
Claim: If embryonic stem cell research was such a promising field, it
should have produced hundreds of cures by now. Over 30 years of
research into embryonic stem cells has proved fruitless. The truth: The
first of human embryonic stem cells were not isolated until 1998, and
research with embryonic stem cells was not awarded Federal funding
until 2002. That was only 5 years ago. To put this in context, from the
first research into a vaccine for polio, over 20 years passed before
doctors first developed the first effective polio vaccine. Hundreds of
Nobel laureates agree that embryonic stem cell research has great
potential for developing cures, but this will take both funding and
time. The NIH has provided over half a billion dollars each year in
Federal funding for stem cell research since fiscal year 2003, but only
a small fraction of those funds has gone to embryonic stem cell
research.
Claim: There are inadequate ethical guidelines in S. 5. In fact, this
proposed legislation has tougher ethical guidelines than those which
currently exist. This legislation provides the ethical framework we
need for this legislation. This proposed legislation makes sure that,
first, the only embryos that can be used are those which are created
for fertility treatments and which are in excess of the clinical need
and would be discarded; second, there must be written, informed consent
from the donors; third, donors can receive no financial reward for
their donations.
These two facts are important to me as I listened to the
misinformation about the way we are going to subject women to egg-
harvesting and this rampant practice of selling eggs on the open
market. Both of those things are prohibited in this legislation. Donors
cannot receive financial reward for their donations, and it has to be
only eggs that would otherwise be discarded.
Fourth, the Director of the National Institutes of Health must issue
guidelines 60 days after the enactment of this legislation.
Finally, it is interesting to note that some of the 21 stem cell
lines that are currently being used for embryonic stem cell research
might not even meet the strict guidelines that are contained in this
legislation.
Families all across America are using medical research to participate
in the miracle of birth.
Fact: The process of using medical research to enhance the likelihood
of pregnancy produces an excess of eggs. I have heard no claims to the
contrary because that is the fact.
Fact: Thousands of these eggs are going to be destroyed. I have heard
a lot of claims in this Chamber, but no one is arguing with a straight
face that the process of producing eggs for in vitro fertilization does
not produce thousands of excess eggs.
Fact: Thousands of these eggs are going to be destroyed. It is just
that simple.
Here is the question. This is the question of the day: Is it better
to use these eggs to save lives as opposed to throwing them away? It
really boils down to that. Ultimately, if some of our colleagues say it
is wrong to use these eggs to save lives, then surely these same
colleagues must believe it is wrong to throw them away. Where is their
legislation outlawing their destruction? In other words, where is their
legislation outlawing in vitro fertilization? Because inherent in that
process is the destruction of human embryos.
I come from Missouri, where we say what we think and we mean what we
say. Two of Missouri's finest and most respected leaders have spoken
quite eloquently on the subject of embryonic stem cell research.
Senator John Danforth, a former Republican Member of this body,
strongly supported the stem cell initiative that was put successfully
before voters in Missouri in 2006. An Episcopalian minister, Senator
Danforth voted many times in this Chamber as a Senator who believed
that abortion should not be legal in this country. An Episcopalian
minister, Senator Danforth has also worked through the moral and
ethical issues he had with embryonic stem cell research. When asked
about the equality of a multicelled embryo in a petri dish and the life
of a human child suffering from a debilitating disease, he put it in
context by asking simply: If a house were on fire and you had to make
the choice, would you rescue a petri dish or a 3-year-old child?
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Doctor William Neaves is the president of the Stowers Institute for
Medical Research in Kansas City, one of the finest research
institutions in the Nation. One of the most spiritual and thoughtful
men I have known, Dr. Neaves has studied the moral and ethical
implications of in vitro fertilization and stem cell research over the
last 25 years with his wife, who is also a bioethicist and an ordained
Methodist minister. He struggled with his position on these issues due
to his faith and upbringing, but in the end, upon reflection and
studying the Bible, he concluded that embryonic stem cell research is
morally and ethically acceptable.
I will close with Dr. Neaves' words:
Two elements have been pivotal in forming my belief. The
first is the biological fact that in normal human
reproduction, most blastocysts, or embryos, perish rather
than implant in the uterus. The second is Ecclesiastes 11:5
in the English Standard Bible:
As you do not know the way the spirit comes to the bones in
the womb of a woman with child, so you do not know the work
of God who makes everything.
Many people of faith believe that research with embryonic
stem cells represents a perfectly moral means of fulfilling
the biblical mandate to heal the sick. Other people of faith
disagree. Should Federal policy disqualify a field of
research from competing for Federal funds because some
Christians object to it? As a Christian who supports this
research, I certainly hope not.
I yield the floor.
Mr. HARKIN. I thank the Senator from Missouri for a very eloquent and
poignant statement. I know the Senator mentioned that recently she came
off a campaign in Missouri. I know that, in listening to her statement,
she is reflecting the wishes and hopes of so many people in her own
State who want to make sure we move ahead and find cures and
treatments. I thank her for her eloquence and for her forthright
statement on behalf of embryonic stem cell research.
Mr. President, I now yield 10 minutes to the distinguished Senator
from Colorado.
The PRESIDING OFFICER. The Senator from Colorado is recognized.
Mr. SALAZAR. Mr. President, I rise today to discuss the question
currently before the Senate regarding whether to allow Federal funding
for embryonic stem cell research. Let me start out my remarks, first,
by acknowledging Senator Harkin and the great work he has done in this
field. It is beyond a doubt that he is an expert on embryonic stem cell
research, one of our national leading experts in terms of health care,
and having been an advocate in that area, he is recognized across this
country. I admire his work on this legislation, as well as the work
that has been put into this legislation by a number of colleagues,
including many on the Republican side of the aisle who have joined this
bipartisan coalition to make stem cell research a reality for the
people of America.
At the end of the day, S. 5 is about hope--about hope for over 1
million Americans who today suffer from the trembling caused by
Parkinson's disease. It is about hope for the over 1 million people in
America who suffer from Alzheimer's disease. It is about hope for the
17 million Americans who suffer from diabetes, including the hope that
we should be giving to those young people who are suffering from
juvenile diabetes and have to look at a life of dealing with the
difficulties of that illness. It is about hope for the more than 64
million Americans who today suffer from one or more forms of heart
disease. So the debate on the floor today is, in fact, about the hope
and aspirations of all Americans, including people, many of whom are
related to Members in this Chamber today.
Scientists in America agree that, without a doubt, embryonic stem
cell research holds great potential for curing these and other
diseases. It is remarkable that against the conclusive determination of
the scientific community, we have the Federal Government in a position
where it is actively withholding the financial support that is needed
to carry on this very important research for America. That is not the
American way. The American way is to open new doors of hope. We ought
to be opening new doors of hope as well with the passage of this
legislation later today.
The reason that scientists are so excited about the potential of
embryonic stem cell research--and the reason that this kind of research
may hold the cure for a whole host of diseases--is that embryonic stem
cells have the potential to become virtually any kind of cell in the
human body, such as brain cells, heart cells, or cells that produce
insulin.
The difficult part of embryonic stem cell research for scientists is
controlling the process by which embryonic stem cells become other,
more specialized kinds of cells. Much more research into that process
is needed. To quote a document prepared by the National Institutes of
Health, ``the promise of stem cell therapies is an exciting one, but
significant technical hurdles remain that will only be overcome through
years of intensive research.''
The Federal funding this legislation authorizes will provide a
critical boost to that effort.
Mr. President, like millions of other American families, my family
has been touched by the ache of loss brought about by Alzheimer's
disease. My father died of complications related to the disease only a
few years ago. At the end of his life, I wanted nothing more than to be
able to help ease his suffering. Now, as I reflect on that difficult
time, I think of the families that are currently enduring the same pain
mine did, and I want to help them.
I trust the vast majority of the scientific community that believes
embryonic stem cell research may hold the key to the cures these
families are seeking. I also believe that our Government can work to
promote this science responsibly by paving the way for treatments that
will save millions of lives without destroying others.
Toward that end, I believe the legislation passed by Congress last
year and before the Senate today represents a measured, responsible
step toward tapping into the vast potential that embryonic stem cell
research has with respect to finding cures for Alzheimer's,
Parkinson's, diabetes and a wide range of other devastating diseases.
In millions of cases, this legislation could mean the difference
between a normal life and one of pain and suffering. In millions of
other cases, it could mean the difference between life and death. And
by authorizing Federal funding only for research on embryonic stem
cells that will never become human life and that are donated willingly,
it achieves its objectives without destroying the potential for life.
To be sure, support from private funds for this research has been
welcome. But it is simply not enough. I have heard from scores of
scientists in my home State of Colorado--working in university labs as
we speak, trying to find cures for our most devastating diseases--who
tell me that the Federal funding this legislation would authorize would
boost their capabilities exponentially.
In addition to the practical impact on American laboratories,
however, there is something else to consider. I can think of no other
Nation that should lead this research with strict guidelines than the
United States.
Throughout our Nation's history, America has been the leader in
making monumental scientific strides that have made life easier and
better for people in our country and all over the world. In a field
with such great promise, and at a time where American competitiveness
is at the forefront of the Congressional agenda, I believe we must once
again be the global leader.
Mr. President, I want to be clear that I also believe we should
promote alternative methods of creating embryonic stem cells. For that
reason, I strongly support the other proposal that is currently before
the Senate, S. 30, which would intensify research into these
alternative methods.
I yield the floor.
Mr. HARKIN. Mr. President, how much time do we have remaining?
The PRESIDING OFFICER. The Senator from Iowa has 37 minutes.
Mr. HARKIN. I yield until 3:45 to the Senator from New York, Senator
Schumer.
Mr. SCHUMER. Mr. President, first, I rise in strong and profound
praise of my colleague from Iowa. He has led this fight dauntlessly,
always being both dogged and smart. That is why we are where we are
today.
I rise in support of S. 5, the Stem Cell Research Enhancement Act.
Today, as we stand on the brink of scientific breakthroughs, we cannot
let politics pull us backward. A modern nation
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loses its greatness, its preeminence, when it turns its back on
science. That is what history has shown.
Stem cell research is the key to hope for 100 million Americans and
their families who suffer from debilitating diseases. Talk about it any
way you want, spin it any way you want, talk about all these
alternatives; the bottom line is very simple: A ``no'' vote is a vote
against science, a vote against the millions who are anxiously awaiting
a cure for diabetes, Alzheimer's, Parkinson's, spinal cord injuries and
other diseases and injuries.
Unfortunately, we all know someone with a disease such as diabetes,
heart disease, Parkinson's, ALS or cancer who could benefit from
embryonic stem cell research. Every one of us has looked into the eyes
of somebody who needs help--in my case, a young mother with a little
girl about 5 years old who had juvenile diabetes who said: Senator, the
doctors tell me the odds are high that my child could be blind at age
20 if we don't do embryonic stem cell research. How can we say no to
that mother and to that child? Scientists are on the cusp of making
incredible progress through stem cell research, a process that has the
potential to cure diseases that have been with us for centuries, such
as diabetes and heart disease.
When their progress was stalled in 2001 when President Bush limited
federally funded stem cell research to only 19 sources that are truly
viable, every family who had hope was set back. With that Executive
order, the President shut the door on hope for all those families.
With that one action, the President not only stopped current research
in its tracks, he sent a message to future scientists that they should
not pursue this line of work.
As they see a limited funding stream for the work they do, fewer and
fewer graduates are specializing in this type of research, and those
who are deeply committed to it tend to go overseas. That is not a great
America--an America that turns its back on science and puts politics in
its place. We want all the best minds in the country to be working
together to find a cure for these debilitating diseases.
S. 5 would answer the prayers of millions of families. It would
increase the number of stem cell lines that can be used by researchers
who are funded by Federal grants.
These stem cell lines are not made from new embryos that would be
created for the purpose of research. They would not be harvested from
women, like some people think. These lines would be made from leftover
embryos created by couples who were trying to conceive through in vitro
fertilization but are not used and are going to be destroyed. With
passage of this bill, those embryos could contribute to critical
research instead of being thrown away.
Let's think about the good that having these new stem cells could do
by looking at juvenile diabetes. As many as 3 million Americans have
Type I diabetes, with over 13,000 children newly diagnosed each year.
These children must be injected with insulin multiple times each day
and prick their fingers to test their blood sugar as many as six times
a day.
That doesn't have to be the reality forever. Researchers have already
demonstrated they can produce insulin-producing cells from
undifferentiated embryonic stem cells. This has the real potential to
develop a cure for juvenile diabetes, providing relief to the 3 million
Americans and their families who are burdened with the implications of
the disease every day.
Without being able to use Federal funding for their research,
innovative stem cell research is being relegated more and more to only
those individuals and institutions that can afford it.
Because NIH-funded research activities have to be housed in different
buildings from stem cell research labs, which has created enormous
headaches and financial barriers for researchers in my State of New
York and has hampered both research on stem cells and research using
other methods, unless we vote yes on S. 5, we are not going to make
progress.
This bill would provide enormous hope to growing numbers of
Americans. It would accelerate the movement toward a cure for
devastating diseases, while strengthening the rules on ethics that must
be involved in this research. This is one of those issues that hits
home more than anything else. Everyone knows a mother with Alzheimer's
or a neighbor with diabetes. They are gut-wrenching situations.
What is most heartbreaking is to think the President's first veto was
to stop us from alleviating all this terrible pain. I urge my
colleagues to look into the eyes of a young child with juvenile
diabetes, look into the eyes of a middle-aged couple who has a parent
suffering from Alzheimer's. Don't say no to them.
I yield the floor, and I yield the remainder of my time back to the
Senator from Iowa.
Mr. ENZI. Mr. President, throughout the history of our Nation,
generations of American scientists have looked for ways to improve the
human condition and address the problem of disease and the afflictions
of old age. Working in labs either spartan or spacious, they have
toiled together over the years to find cures for the health conditions
that continue to plague mankind.
As they conducted their research, each scientist's work built on the
discoveries that preceded it, and the results they achieved over the
years have enabled us to live longer, healthier, more productive lives.
The list of medical miracles and marvels that have come from their work
has made the phrase ``American ingenuity'' known around the world for
the creativity it represents and the results it has so often provided.
From time to time, however, there is a breakthrough--or possible
breakthrough--in medical science that has the potential to
revolutionize not only our ability to diagnose or treat an affliction
but our basic understanding of how the human body operates. When that
occurs, a debate ensues as society attempts to evaluate the new
procedure's potential to address the diseases that threaten our health
as well as the ethics of putting the new procedures into practice.
Such a possible breakthrough is stem cell research. At present, its
promise and potential for changing the way we view health and disease
seems limitless. In theory, stem cells may be capable of doing
everything we can possibly imagine--and more. Unfortunately, there is
often a wide gap between what is possible in theory and what is
practical and possible in the real world. What the future of stem cells
will be no one knows for certain. Still, the possibilities are more
than intriguing and certainly worth an in-depth look.
The research that has been conducted into stem cells so far has been
so exciting because of the very nature of these cells. Stem cells have
the capacity to renew themselves and then become specialized cells.
Most of the cells that are in the body are created and committed to
performing a specific function. A stem cell remains ``on the fence,''
however, uncommitted until it is given a signal by the body to develop
into a specialized cell.
That ability to change and become a cell that can be used almost
anywhere in the body has fascinated scientists who are studying the
ability of the body to repair itself through the use of using these
``uncommitted'' cells.
We have all heard the saying--you don't have to be a weatherman to
know which way the wind is blowing. In this case, however, you really
do need a strong background in science to understand fully the
specifics of stem cell research and its implications for the future.
Fortunately, we are not here to predict the impact stem cells will have
on our health care system in the years to come. We are here to make a
determination as to the wisdom of using taxpayer dollars to finance
additional work in this area--and then pick the best vehicle to support
it. There is a big difference.
In debating and voting on the two bills before us today, we are not
making a judgment about the science itself, as others have stated.
Rather, we are making a judgment about whether that science should be
supported by taxpayer dollars. We are deciding the appropriate moral
construct for the work of those key scientists in manipulating and
possibly even destroying the basic building blocks of human life. We
are reaffirming how we as a society view the embryo and its function.
Every year, within our appropriations bills, we make a judgment about
how we want to treat embryos--the very beginning of human life. The
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Dickey-Wicker amendment is clear. Federal dollars cannot be used for
creating human embryos for research purposes or for research in which a
human embryo or embryos are destroyed, discarded, or knowingly
subjected to the risk of injury or death greater than that allowed for
research on fetuses in utero. Therefore, every year, as part of the
appropriations process, we reaffirm that science must be guided by
moral values, and our values as a society compel us to place certain
limits on the pursuit of science. Today's debate will consider whether
our values as a society compel us to maintain certain limits on
taxpayer funding of embryonic stem cell research.
Without question, science must be guided by morality. There have been
too many instances over the course of human history in which terrible
things have been done in the name of science. Scientific exploration is
important and we should do everything we can to further our knowledge
of ourselves and our world, but not at the expense of disregarding the
moral viewpoints of millions of Americans who don't believe their taxes
should pay for something they find abhorrent.
In determining how to proceed, we of course must consider the promise
of stem cell research. But in considering that promise, we must make it
clear that while stem cells may someday lead to therapeutic
advancements for devastating diseases like Alzheimer's, diabetes,
Parkinson's, leukemia, and spinal cord injuries, that day has not come
yet. That is why we must be careful not to oversell the promise of this
research to the American people because this field of research has not
yet resulted in human clinical trials. Every reputable scientist will
admit that any possible cure or advanced treatment using embryonic stem
cells are many years away. There are currently no cures waiting to be
plucked off laboratory shelves after our votes on these bills.
So, while the research provides great hope for millions of Americans,
at this point, the full benefits have not yet been realized. They fire
our imagination as we consider the possibilities that may or may not
come to pass. Whether embryonic stem cells will fulfill their promise
someday is still very much in question, and much work is already
ongoing to see whether we can get an answer.
In this context, I want to further discuss S. 5, the Stem Cell
Research Enhancement Act of 2007. A similar bill was passed the House
on January 11, 2007, by a vote of 253 to 174. S. 5 would allow
additional research on embryos from in vitro fertilization procedures,
under some limited circumstances.
However, even in these rather limited circumstances, I must oppose S.
5, because the limits it imposes on taxpayer-funded science do not
respect the moral value of a human embryo. It does not fully recognize
our decision within Dickey-Wicker and other contexts to treat the human
embryo as more than simply material for scientific research.
The supporters of this bill will acknowledge that it does not limit
research to human embryos that are currently frozen but extends the
window for that research well into the future. By doing so, the bill
creates an incentive for the creation of embryos solely for research
purposes. This is contrary to what Congress reaffirms within the
Dickey-Wicker language each year.
And, although the bill prohibits financial and other inducements for
the parents of the embryo, it does not eliminate financial or other
inducements for the clinics and doctors that create the embryos. Thus,
it does not eliminate the financial incentives for in vitro
fertilization clinics to create more embryos than are absolutely
necessary to help parents conceive a child. This loophole will further
erode the congressional prohibition through Dickey-Wicker against the
creation of human embryos solely for research purposes.
I am not opposed to embryonic stem cell research, but I am opposed to
the provisions of S. 5. I would welcome the opportunity to debate
amendments to the bill, but the agreement that governs our debate does
not permit amendments. And, without an opportunity to amend S. 5, I
have no choice but to vote against it.
However, I will support alternatives, such as the Isakson-Coleman
bill, so that we can allow greater Federal support for embryonic stem
cell research. I believe we can and should unite behind a bill that
respects the diversity of our views on human embryos, but still pushes
the science forward. The Isakson-Coleman legislation is such a bill.
A vote for or against S. 5 is not a vote for or against scientific
advances. After all, if we truly trust science, we ought to give
science a chance to solve this dilemma over embryonic stem cell
research. As outlined by the report from the President's Council on
Bioethics, researchers are exploring at least five different ways by
which we can create stem cell lines without harming or destroying
embryos. If these researchers are successful, then the arguments
against Federal funding of embryonic stem cell research will fall away.
Further, States and private research organizations are already
plowing billions of dollars into human embryonic stem cell research
that goes beyond the parameters of President Bush's policy. Let those
efforts continue, while we continue working in Congress to support stem
cell research that doesn't involve harming or destroying an embryo,
which is something that the vast majority of Americans could support.
Mr. BUNNING. Mr. President, I would like to take a few minutes to
talk about the two bills before us today dealing with stem cell
research.
One of these bills is wrong, while the other offers us a chance to
advance scientific research using stem cells while still protecting the
sanctity of life.
Stem cell research remains a controversial issue in the medical,
scientific and religious communities as well as in Congress. In fact,
just last July, we were debating this very topic, and here we are again
today.
I am not opposed to stem cell research. I believe that many forms of
stem cell research offer great hope to millions of Americans suffering
from various diseases, including research using adult and umbilical
cord stem cells. We are already seeing medical advances in this type of
research. In fact, adult stem cells have proven effective in combating
several serious conditions, such as diabetes and spinal cord injury.
Also, just recently in the papers, scientists announced that amniotic
fluid may be a promising source of stem cells. This shows we have a lot
to learn about stem cells.
I am 100 percent opposed to embryonic stem cell research, however.
This is why I will be voting against S. 5, the Stem Cell Research
Enhancement Act of 2007.
This bill would remove all current protections against the
destructive use of embryos for harvesting embryos for stem cells. I
believe it is morally wrong to take embryos in the early stages of life
and destroy them, even for research purposes. We should protect human
life--not destroy it.
Back in 2001, the Bush administration began allowing Federal funding
for embryonic stem cell research on a limited number of stem cell lines
that were already in existence. As an opponent of the destruction of
human embryos, I opposed the Bush administration decision to allow some
embryonic stem cell lines to be used for Federal research.
However, S. 5 goes even further than the current policy by removing
the current limitations set by the President on federally funded
embryonic stem cell research. The bill allows Federal funds to be used
for this type of research on embryos created for fertility treatments.
This is the wrong direction for us to go. It is immoral for us to
conduct medical research on these budding lives, and American taxpayers
should not be forced to pay for this type of research. Some people have
argued that these embryos are ``excess'' and will be destroyed anyway.
I firmly believe that we cannot create a human life and then destroy it
in order to save a life. Ethically, it is unjustifiable.
In fact, it is important to remember that embryonic stem cell
research is not illegal. There are just limitations on the Federal
funding for it. Anyone can conduct embryonic stem cell research. They
just have to live by the federal regulations or rely on other sources
of money.
The other bill we are considering today, S. 30, the Hope Offered
Through Principled and Ethical Stem Cell Research Act, offers us an
opportunity to
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further stem cell research in an morally defensible manner. The bill
would allow stem cells to be derived from embryos that die naturally,
and reinforces the current policy that federally funded research should
not involve destroying or discarding embryos.
This bill provides access to embryonic stem cells, but protects human
life and avoids the ethical pitfalls of S. 5. It seems to me that we
should all be able to support this bill. It places reasonable
restrictions on additional embryonic stem cell research, while also
protecting human life. I urge my colleagues to support this bill.
No one likes to see people with medical conditions suffer, and like
many Americans my family and friends have certainly been stricken with
terrible diseases over the years. However, we are at an ethical
crossroads with this issue, and we must stay true to our values of
respecting life.
It seems foolish to barrel ahead with Federal funding for embryonic
stem cell research as S. 5 does, when other alternatives are available
that offer real hope to patients and promise in research.
In closing, I firmly believe that we cannot create life and then
destroy it, even if to save another life. I urge my colleagues to vote
against S. 5, and vote for S. 30.
Mr. DOMENICI. Mr. President, I rise today in opposition to S. 5, the
Stem Cell Research Enhancement Act of 2007. Although I am not opposed
to stem cell research and in fact enthusiastically support some types
of stem cell research, I cannot support this bill.
This is a very difficult vote for me to cast. I have spent a
considerable amount of time thinking about the issue of Federal funding
for stem cell research involving the destruction of embryos. Over the
last several years, scientific developments in human genetics have been
proceeding at a rapid pace. This kind of research has the potential to
be very helpful in the understanding of human development and the
treatment of human diseases. However, this type of research also raises
serious ethical and public policy questions that must be confronted.
What limits do we place on research with human embryos?
Experimentation with embryonic stem cells is considered by some to be
a revolution in medical research. Many in the medical, public and
scientific communities believe that embryonic stem cell research could
lead to the cure for such sicknesses as Parkinson's disease,
Alzheimer's and diabetes. However, human embryos must be destroyed in
order to derive embryonic stem cells and this is where my ethical
dilemma arises.
It is my deeply held and personal belief that an embryo is an actual
living being; it is not merely a potential living human being. The
possibility of helping those who are sick may be a very powerful
motivation, but I strongly believe that human embryos deserve the same
respect as any other human being and it is never morally or ethically
justified to kill one human being in order to help benefit another. It
is for this reason that I cannot support the use of human embryonic
material for research even if it has the potential to save others. I
cannot accept the diminished status of the human embryo in order to
justify their destruction in the course of research solely because they
may theoretically provide potential benefits for another human being
sometime in the future.
I want to make it clear that my ethical problem is not with the
research itself but rather with the destruction of embryos. I believe
there is potential for advances in stem cell research that does not
involve the moral dilemma of destroying an embryo in the process. It is
for this reason that I support S. 30, The Hope Offered through
Principled and Ethical Stem Cell Research, HOPE, Act.
The HOPE Act will advance alternate forms of stem cell research by
intensifying research on methods that do not involve the destruction of
human embryos. This bill instructs the Secretary of Health and Human
Services to develop techniques for the isolation, derivation,
production, and testing of stem cells, provided that such techniques do
not involve the creation of human embryos for research purposes; or the
destruction or discarding of, or risk of injury to, a human embryo.
Research that can benefit others without the destruction of human life
is in my opinion the best path forward.
Scientists have shown they have the skill and ability to pursue the
potential benefits of stem cell research without endangering human life
in the process. I support these alternative approaches because I truly
believe that they have the potential to help people while still
maintaining ethical guidelines. This is the best way to allow Federal
science-research on stem cells without offending the beliefs of
millions of Americans.
Mr. ALLARD. Mr. President, I rise today to clarify my position on
stem cell research. As a veterinarian I understand the need for
research and scientific advancement. Current law does not prohibit any
sort of stem cell research. In fact, all forms of stem cell research
have flourished under current law.
I can not and will not support legislation that would drive abortion.
Therefore I cannot support S. 5. This legislation would allow for
Federal dollars to be used to incentivize the further destruction of
human embryos for research purposes. I do not support this use of
Federal funds. I will not oppose private industry from doing embryonic
stem cell research, but it would be very irresponsible to use Federal
taxpayer dollars to fund such a contentious issue.
Science is advancing. Over the past weeks and months research using
adult stem cells has had many breakthroughs. The use of amniotic fluid
and placental stem cells has much of the same potential that embryonic
stem cells have, but they are not as controversial. S. 30 provides
resources to further research in the area of adult stem cell research.
Because of the emphasis on adult stem cell research, I support S. 30
and will vote in favor of S. 30 later today.
I not only understand the need for scientific advancement, but also
for ethical boundaries. We should not be using Federal dollars to drive
abortion, when there are alternative opportunities for scientific
advancement that are not as contentious.
Mr. KYL. Mr. President, we live in an age when medical miracles are
occurring every day, many in my home State of Arizona. Breakthroughs
are treating and curing children and adults who could have died from
their diseases just a few years ago. And some of these cures and
treatments are the result of stem cell research.
For example, thanks to the Cord Blood Registry located in Tucson,
children and adults are being treated, and often cured, of once
terminal diseases such as leukemia, aplastic anemia, cerebral palsy,
and sickle-cell anemia. And these are just a handful of the 72 diseases
that have undergone clinical trials or been treated using stem cells
obtained from bone marrow and umbilical cord blood.
I favor the broadest possible effort to pursue promising medical
technologies within appropriate ethical limits. Scientists have derived
stem cells from two principal sources: the tissues, fluids, and organs
of adults, and cells from human embryos. Human embryonic stem cells
have only been obtained through a process that destroys the embryo.
In the last Congress, we passed, and the President signed into law,
the Stem Cell Therapeutic and Research Act of 2005. This legislation
was intended to spur additional advances by establishing an
infrastructure to facilitate the collection and dissemination of two of
the most promising categories of adult stem cells: those derived from
bone marrow and those derived from umbilical cord blood. Based on
reports in the media over the past 2 weeks, I would say this bill has
been a success.
For example, the New York Times reported on a coming revolution to
sports medicine from adult stem cells that could be able to heal and
rehabilitate tendons, ligaments, muscle and cartilage.
More significantly, ABC News reported that adult stem cells are being
shown to be useful in repairing damaged heart muscle. While this has
been known for some time in other countries, U.S. doctors and
scientists are now embarking on the first human clinical trials. This
may turn out to be one of the most significant breakthroughs in recent
history for treating the most deadly disease in the United
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States--heart disease--which last year claimed the lives of almost
500,000 Americans.
What's more, a recent study conducted by the Wake Forest University
School of Medicine promisingly resulted in scientists harvesting stem
cells from amniotic fluid, which is the fluid that surrounds a baby
before it is born. These amniotic stem cells offer many of the benefits
found in embryonic stem cells, and without its ethical complications,
demonstrating just how much faster science is moving than politics.
Those researchers at Wake Forest found that amniotic-fluid stem cells
proved successful in producing bone, heart muscles, fat, nerve, and
liver tissues. All of this was possible without destroying the nascent
life in an embryo.
By contrast, embryonic stem cell experiments have not yielded any
treatments for human patients. Nevertheless, researchers believe there
is much potential there, so a great deal of private and public money
has been raised to pursue it.
In 2001, the President issued an Executive order that made available
for the first time Federal funding for embryonic stem cell research
using embryos that had already been destroyed. In the subsequent 6
years, the Federal Government has spent more than $130 million on this
type of stem cell research and has spent more than $2.5 billion on all
stem cell-related research.
In 2006, the Senate considered legislation that would have overturned
a key element of the current policy: the stipulation that Federal
taxpayers' money cannot provide an incentive for the further
destruction of human embryos. While this bill was approved by Congress,
it was later vetoed by the President.
I voted against this legislation because I believe that taxpayers
should not have to subsidize the destruction of nascent human life,
especially when a number of State governments and large universities
have directed significant resources to embryonic stem cell research.
Since there are already billions of dollars available for embryonic
stem cell research on lines from newly destroyed embryos, increases in
Federal funding and a change in the Federal policy are not necessary.
S. 5, which we are debating today, and which is similar to
legislation already passed by the House, is essentially the same
legislation as that the President vetoed last year. There is one
difference: added to S. 5 is legislation that was passed unanimously by
this body last year--the Alternative Pluripotent Stem Cell Therapies
Enhancement Act. I supported that legislation, which was not passed by
the other body. However, that very positive legislation is attached to
legislation I cannot support because it would force taxpayers to
subsidize the destruction of nascent life.
Thankfully, S. 30 is also being considered today. I fully support
this legislation offered by Senators Coleman and Isakson. Their
leadership has brought to the floor a bill that would build on the
research that is treating patients now. This legislation would direct
the Department of Health and Human Services to seek out alternative
sources of stem cells and to study the possibility of establishing an
amniotic and placental stem cell bank, similar to the bone marrow and
cord blood stem cell bank, while reaffirming a policy that prohibits
research that destroys human life.
We can all agree: stem cell research holds promise and has already
provided life-saving treatments and cures. And we should continue to
support that research within appropriate ethical restrictions. I urge
my colleagues to oppose S. 5 and support S. 30.
Ms. SNOWE. Mr. President, I rise today to speak to an issue of
tremendous significance to countless Americans and to generations to
come--the matter of stem cell research. I thank the majority leader for
his efforts to ensure consideration of stem cell legislation. The
bottom line is, there is research we should be conducting today that
could help us treat--and in some cases cure--some of our most serious
diseases. That is why two-thirds of Americans favor embryonic stem cell
research and why I am an original cosponsor of the Stem Cell Research
Enhancement Act.
The promise of stem cell research lies in the simple fact that
embryonic stem cells have the unique potential to develop into any of
the cells which could be needed to treat the multitude of diseases from
which Americans suffer. The vast potential of stem cell therapy is key
to future therapies because in so many diseases, cells in the body are
damaged or destroyed, and their role is often irreplaceable. Stem cells
offer an opportunity to actually replace the function which was lost.
Consider today that 20 million Americans live with diabetes. Despite
treatment with drugs and insulin, many diabetics experience vision
loss, injury to extremities, heart disease and other complications. For
years, scientists have sought to find a cure. And today stem cells
offer that potential to end dependence on insulin--freeing millions
from diabetes.
In many diseases, there simply is not an effective therapy to replace
the function which individuals lost or damaged cells can no longer
provide. Today there are limited treatment options for brain disorders
such as Parkinson's disease and ALS or Lou Gehrig's disease. For such
diseases, stem cell therapies offer promise that we could alleviate the
suffering that millions now experience.
This week the Senate is considering two bills. The first of these
promotes stem cell research. It encourages research which is already
underway--which is eligible today for both private and public funding.
And while that research should be encouraged, it is not facing
impediments, save for the fact most of us would like to see greater
progress in biomedical research funding--and stop the erosion of the
budgets of the National Institutes of Health.
Yet since no impediment exists to the work described this first bill
describes, this legislation is--despite its positive aspects--a
distraction from a crucial question. That is, whether we will continue
to impede progress in human embryonic stem cell research.
The problem is, that while scientists are tackling stem cell research
on multiple fronts, to ensure success they try to predict the path most
likely to be successful. In that regard, we know that embryonic stem
cells have the potential to develop into any cell type of the body.
That is why scientists have sought to use them in their race to create
cures.
Today, Federal funding for research is restricted to a small number
of embryonic stem cell ``lines'' that were established prior to August
9, 2001. Unfortunately, only 19 of those 78 stem cell lines in
existence are available to researchers, as many were found to be
contaminated or otherwise unusable. We recognize today that even when a
stem cell line is created, it simply cannot reproduce indefinitely.
So, many scientists are frustrated, are perplexed that a Federal
funding restriction would essentially block their efforts to develop
cures. Some have proposed they should use adult stem cells. Yet those
involve a detour in the journey to a cure.
We know that in order to use embryonic stem cells to make cells which
can be used to treat a disease--like diabetes--scientists must learn
how to make the cell become the right type. But an adult stem cell is
actually already somewhat specialized, so one cannot directly use them
to produce many of the types of cells we need to produce new therapies.
Some advocates of adult stem cell research say we could try to take
such a stem cell and reverse its development--back to an embryonic
stage--and then begin the task to develop it into the specialized cell
required. It is as if you were driving down an interstate on a trip,
took an exit, made a few turns, and then decided to back up--in
reverse--all the way to the interstate in an attempt to try another
destination. This is not an efficient way to get where you are going.
And any scientist will tell you, the more steps you must take, the more
chance there is that something simply won't work.
Recently some have proposed that scientists could use other types of
cells. We have learned recently about stem cells which are found in
amniotic fluid--``amniotic stem cells''--which also appear to have
potential to develop into different types of tissues. This is an
encouraging development, yet much remains to be learned about those
cells. The leader of the research group which has just described these
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cells--Anthony Atala--was recently asked whether his research ends the
argument over whether embryonic stem cells are needed. He answered that
question simply:
It does not, mainly because it's another stem cell choice.
And I think you really can't tell which cell is going to be
best for which indication, and all cells have advantages and
disadvantages.
That is truly the statement of a scientist. Because we do not yet
know about the full potential of these alternatives to embryonic stem
cells. But we do know that embryonic stem cells can develop into any
type of cell. That is why losing years in which we could have made
progress is so tragic. There is so much that scientists have yet to
learn, and while we always hope for quick cures, experience shows that
medical breakthroughs typically result from years of concentrated
effort--and we cannot wait any longer to embark on that journey.
That is why I am a cosponsor of the second bill which we are
considering--the Stem Cell Research Enhancement Act. This legislation
addresses the critical issue which has inhibited research here in the
U.S.--the restriction of Federal funding to only those few stem cell
lines which were in existence back in 2001. Our legislation would
ensure that Federal research would only use stem cells from embryos
which would otherwise be destroyed and would require full consent from
the donor before coming into use. I thank Senators Specter and Harkin
for their leadership on embryonic stem cell research.
The legislation which they have championed sets a very constrained
set of circumstances under which embryonic stems cells may be obtained
in order to assure we can move this vital research forward within an
ethical framework. Never will an embryo be created for research
purposes, nor does this legislation facilitate such studies. This
legislation assures that an embryo may be used only when it would not
ever be used for infertility treatment. Donation must be voluntary,
under full informed consent and no financial or other inducement may be
given.
The fact is that fertility treatment has allowed many to have
families whom otherwise could not. A consequence of this remarkable
therapy is that some embryos are created which will not be used. I must
note that under the Stem Cell Research Enhancement Act, it will be the
couple who will--under no bias--decide whether they will be used. This
legislation facilitates that donation.
Today Americans who have faced fertility problems are facing the
question of what to do with unused embryos. Indefinite storage is not
truly an option--we know that we cannot maintain the viability of these
embryos indefinitely. So given the choices available, some couples see
the potential to help those suffering from serious disease. It assures
that this gift can be given and used to help medical progress.
I believe many Americans who have undergone fertility treatment and
realized a gift of life in their families will opt to save lives
through a donation which promises to save many lives. But it must
always be individual conscience that is the determinative factor--and I
respect the views and conscience of each and every individual on this
matter.
There can be no doubt that stem cell research will move forward. The
real question is whether our Nation will be engaged--whether our
scientists will realize the breakthroughs--whether we will produce the
treatments or whether those developments will draw our best minds and
new medical investment abroad, where American vision and oversight will
not influence the future of medicine.
I believe in stem cell research. I believe in it because I cannot
look at a person suffering from a debilitating, and even fatal disease
and support prohibitions which impede ethical research aimed at
alleviating of that suffering. That is why I joined with my colleagues
in the Senate in urging President Bush to ease the current restrictions
on the use of stem cells so that research can move forward and lives
could be saved. That is why I am a sponsor of this legislation. It is
why I urge my colleagues to give that bill their support. This is the
bill which will make a difference. I urge the President to reconsider
this issue, and urge his support.
I think back to President Reagan's passing nearly 3 years ago, and
remember the outpouring of concern we all had for our former President,
and the First Lady and their entire family. We spoke much of the
tragedy of Alzheimer's disease and how we must do more to alleviate the
suffering. Nancy Reagan inspired us all with her courage--and inspires
us no less in her call for research which could alleviate the suffering
from so many diseases. Her recent words call out to us, ``A lot of time
is being wasted . . . A lot of people who could be helped are not being
helped.''
I cannot think of a more significant living memorial to our former
President than to allow more research to be done in order to find new
cures for diseases affecting millions of people.
Today I ask my colleagues to consider allowing individuals--who have
through modern medical science, enjoyed a gift of life, to contribute
to saving other lives. That is exactly what this legislation does, and
that is why we must send this bill to the President and he must sign
it.
Mr. OBAMA. Mr. President, I stand in full support of the Stem Cell
Research Enhancement Act as I did when this bill was introduced and
sent to the President's desk in the 109th Congress. I am proud to be an
original cosponsor of this bill.
I am frustrated by the opposition this bill has generated and
saddened that we are preventing the advancement of important science
that could potentially impact millions of suffering Americans. The
study of stem cells holds enormous promise for the treatment of
debilitating and life-threatening diseases. However, in order to reach
this level of medical achievement, much more research is necessary to
understand, and eventually harness, the amazing potential of stem
cells. Instead of creating roadblocks, we must all work together to
expand Federal funding of stem cell research and continue moving
forward in our fight against disease by advancing our knowledge through
science and medicine.
Each year, 100,000 Americans will develop Alzheimer's disease, with
impaired memory, ability to understand, and judgment. Over 1 million
adults will be diagnosed with diabetes this year, and risk
complications that include blindness, damaged nerves, and loss of
kidney function. We all know or have met individuals with spinal cord
injuries, including national celebrities, local war heroes, and loved
ones from our own families and circles of friends, who are struggling
to maintain mobility and independence.
For most of our history, medicine has offered little hope of recovery
to the 100 million individuals affected by these and other devastating
illnesses and injuries.
Until now.
Recent developments in stem cell research may hold the key to
improved treatments, if not cures, for those affected by Alzheimer's
disease, diabetes, spinal cord injury, and countless other conditions.
Many men, women, and children who are cancer survivors are already
familiar with the lifesaving applications of adult stem cell research.
Patients with leukemia or lymphoma often undergo bone marrow
transplants, a type of stem cell transplant, which can significantly
prolong life or permanently get rid of the cancer. This therapy has
been used successfully for decades, and is saving lives every day.
Yet this breakthrough has its serious limitations. Adult stem cells,
such as those used in bone marrow transplants, can only be collected in
small quantities, may not be a match for the patient, which can lead to
rejection, and have limited ability to differentiate or transform into
specialized cells.
Similarly, the promising advances of stem cell use from a patient's
own cord blood, as illustrated by the success stories of Dr. Joanne
Kurtzberg from Duke University, also have their limitations. If, for
example, a young cord blood recipient's condition should deteriorate
after his or her initial treatment or should develop another illness,
there simply are not enough cord blood cells left for a second use. The
few remaining cells would have to be cloned to get enough cells for
future treatment, or stem cells would have to be obtained from another
source.
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Two of my constituents, Mary Schneider and her son Ryan, are well
aware of the potential of cord blood treatments. Her son, diagnosed
with cerebral palsy at 2 years of age, has made what appears to be a
full recovery after treatment with his own cord blood. Despite the
compelling results witnessed by the Schneider family, they also firmly
believe and support expanded research of embryonic stem cells to combat
disease.
A recent scientific paper about stem cells derived from amniotic
fluid has drawn much attention. While this offers an exciting
alternative to regenerative medicine therapies, the author of that
report, Dr. Anthony Atala, has himself urged that his work on amniotic
stem cells will not replace the continued need for investigation into
treatments with stem cells derived from embryos.
All of these alternative treatments are just that, alternatives, and
are not substitutes for embryonic stem cell research.
Embryonic stem cells can be obtained from a number of sources,
including in vitro fertilization. At this very moment, there are over
400,000 embryos being stored in over 400 facilities throughout the
United States. The majority of these are reserved for infertile
couples. However, many of these embryos will go unused, destined for
permanent storage in a freezer or disposal. We should expand and
accelerate research using these embryos, just as we should continue to
explore the viability of adult stem cell use, cord blood use, and
amniotic fluid use.
The promise of embryonic stem cells has come to light in a recent
achievement by researchers at Johns Hopkins. They were able to repair
damaged nerves and restore mobility in paralyzed rats through embryonic
stem cells. One can't help but wonder when, not if, this research will
be translated into techniques that will help human patients who have
lost the ability to walk.
Of course, any work in this area must have appropriate oversight.
Embryonic stem cell research demands comprehensive, thoughtful, and
carefully crafted ethical and scientific guidelines. We must not only
look to guidance from the National Institutes of Health and the Food
and Drug Administration but also to our reason, our morals, and our
compassion.
The President's veto of the stem cell bill proposed in the last
Congress prevents Government funding beyond 78 previously established
stem cell lines. However, recent estimates on the number of viable cell
lines bring the numbers down closer to 20. Clearly, we are moving
backward in our efforts with these current restrictions. Stymieing
embryonic stem cell research is a step in the wrong direction. It
closes the door on many Americans awaiting new treatments that could
potentially provide a better quality of life or, perhaps, even save
their life.
My hope, and the hope of so many in this country, is to provide our
researchers with the means to explore the uses of embryonic stem cells
so that we can begin to turn the tide on the devastating diseases
affecting our Nation and the world.
Mr. VOINOVICH. Mr. President, I rise today to speak about the
emotional, divisive, and often confusing issue of stem cell research.
Let me start by expressing why I believe we should focus our scarce
resources on adult and umbilical cord stem cells rather than on
embryonic stem cells.
Given the tremendous results that have come from adult and umbilical
cord stem cell therapy in the areas of oncology and orthopedics--and,
more recently, in cardiology and neurology--I am further encouraged by
the possibilities these noncontroversial, adult stem cells have to
offer. In this tight budgetary environment, in which there is a choke
hold on our domestic discretionary spending, we must be vigilant in the
way we appropriate taxpayer dollars and concentrate our resources on
those lines of medical research that hold the greatest potential.
Furthermore, in recent years, scientists have made tremendous strides
in designing methods to obtain fully pluripotent stem cells that have
the flexibility of embryonic stem cells, while avoiding the destruction
of human embryos. The potential to extract these versatile stem cells
in an ethically sound manner, coupled with my interest in seeing
further research in the area of adult and umbilical cord stem cells, is
why I rise to support S. 30, the HOPE Act.
Before I delve into a discussion of the two bills this body is
considering, let me clarify that there are two different categories of
stem cells--and, thus, of stem cell research. The first, embryonic stem
cells--as their name suggests--are derived from human embryos developed
from eggs that have been fertilized at an in vitro fertilization
clinic. Alternatively, adult stem cells are undifferentiated cells
found among differentiated cells in tissues or organs. These cells can
renew themselves and eventually develop into a specific cell in the
body. What is notable, however, is that these undifferentiated adult
stem cells can be gathered by scientists without any harm to the
individual donor.
Umbilical cord blood derived from a mother's placenta following the
birth of a newborn baby is now also included in this category of adult
stem cells. In fact, with the arrival of my seventh grandchild, I
learned a great deal about the benefits of preserving cord blood stem
cells. What at one time was considered medical waste and discarded
after birth is now recognized as a rich supply of stem cells and has
been used to treat a number of blood and immune-system diseases,
cancers, and other physical disorders.
I was introduced to the promise of adult and umbilical stem cell
research by experts at the National Center for Regenerative Medicine in
my hometown of Cleveland, OH. Several institutions make up the center,
including Case Western Reserve University, the Cleveland Clinic,
University Hospitals Case Medical Center, Athersys, Inc., and the Ohio
State University. Together they have created an outstanding medical
facility that is leading the Nation in the use of nonembryonic stem
cells to regenerate new tissues in diseased organs rather than using
drugs or devices to improve the function of the organs.
Since 1976, researchers at the center have been studying nonembryonic
stem cells, and they performed their first stem cell transplant as
early as 1980. Today, the center is capable of conducting clinical
trials with cord blood stem cells for gene therapy and for heart and
blood vessel repair. Investigators at the center are now able to cure
leukemia and lymphomas with nonembryonic stem cell transplantation, as
well as repair unstable bone fractures and treat genetic disorders.
I have had the chance to meet several patients whose lives have been
transformed by this new medicine. Elisabeth, who was a patient at the
National Center, was in a motorcycle accident and had compound
fractures in her right femur and right tibia. Even though she was
rushed into emergency surgery after the accident, her bones did not
heal properly, and she was told she would never walk again. Elisabeth
sought out a second opinion from a doctor at the National Center who
operated a second time, using some of his adult stem cell gel. This gel
takes on the characteristics of the surrounding bone cells and helps
with the healing of broken bones. I am happy to report, Elisabeth is
now walking, living a healthy life, and pursuing a future in physical
therapy at the Ohio State University.
Elisabeth is not alone.
I recently visited the National Center for Regenerative Medicine, and
I had the chance to meet Ashley. Ashley is 8 years old and was
successfully treated for her leukemia at Rainbow Babies and Children's
Hospital of University Hospitals Case Medical Center. She was first
diagnosed with acute lymphatic leukemia, ALL, in January 2006, and she
underwent a stem cell transplant from an unrelated donor in June 2006.
But since her transplant, Ashley has done wonderfully.
Even more encouraging is the potential for scientists to leverage all
this great medicine into new fields, including cardiology and
neuroscience. Researchers at the National Center for Regenerative
Medicine are hopeful that in the not so distant future they will make
inroads in the treatment of degenerative arthritis, will decrease the
severity of graft versus host disease after stem cell transplantation,
and will allow physicians to use a patient's own stem cells to repair
heart damage following congestive heart failure, as
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well as use their own neural stem cells to improve function after
spinal cord damage.
I am concerned, however, that not enough Americans are aware that
some of the most advanced medicine today can be attributed to adult--
and not embryonic--stem cells. What I find even more disturbing is that
many supporters of embryonic stem cell research have been kept in the
dark about the advances of umbilical and adult stem cell treatments and
have been over-sold on embryonic stem cell research, which is still in
its infancy.
I want to remind my colleagues who support the Stem Cell Research
Enhancement Act that embryonic cells have not been successfully used to
treat even one disease yet I have had the opportunity to meet numerous
people whose lives have been saved by adult stem cell therapy. In fact,
adult stem cells have been used to treat 72 diseases, including breast
cancer, multiple sclerosis, rheumatoid arthritis, sickle cell anemia,
spinal cord injuries, and others. That is why I continue to be
encouraged by the possibilities adult stem cells have to offer.
In recent years, medical research has made tremendous strides, and it
is now widely believed that new technology can lead to methods of
obtaining fully pluripotent stem cells that have the flexibility of
embryonic stem cells without destroying potential life. That is why I
rise today to support S. 30, the HOPE Act.
Despite all this progress, scientists around the world agree that
there is still a great deal that remains unknown about the potential
for stem cell therapy. That is why I support this legislation
introduced by my colleagues from Minnesota and Georgia that can help us
tap even more potential cures and therapies.
The HOPE Act would continue to encourage Federal research on adult
and umbilical cord stem cell therapies that are already proving
successful, while requiring the Secretary of Health and Human Services
to develop techniques to identify and derive pluripotent stem cells
that have the flexibility of embryonic stem cells without destroying a
human embryo. There is evidence that these alternative methods may make
it easier for scientists to genetically match patients with therapies
and could reduce the complications, like tumor formation, that have
been seen with embryonic stem cells.
The HOPE Act would also require the Secretary to prioritize stem cell
research that will reap near-term clinical benefit and take into
account the findings of the President's Council on Bioethics along with
other appropriate techniques and research. It is my hope that this type
of progress will help eliminate the controversy surrounding embryonic
stem cell research without any compromise of scientific advancement.
This legislation paves a path forward for Federal scientists, while
respecting the principles and morals of millions of taxpayers.
I believe it is my moral responsibility to direct the Federal
Government's dollars toward research that has the greatest near-term
potential to help the largest number of Americans.
Over the past several years, Congress has increased total NIH funding
for medical research--including increasing the amount of money
available for stem cell research--from $15.1 billion in fiscal year
1999 to $28.9 billion in 2007. However, in recent years the cost of
fighting the war in Iraq, defending our homeland, and protecting
against natural disasters like Hurricane Katrina has left very few
resources for domestic discretionary spending. In fact, today, the
Federal Government spends only one-sixth of its annual budget on
nondefense discretionary spending, and I am afraid that exploding
entitlement spending threatens to soak up every Federal dollar, leaving
no revenue for things like scientific research. There is a tremendous
need to pursue treatments for many diseases, but we face a reality of
limited funding.
We have to be smart about spending our money. In the current budget
environment, I have concerns that increasing funding for research on
embryonic stem cells will take away opportunities for research in areas
like adult and umbilical research that has proven its ability to save
human lives--or even for new techniques to help us remove pluripotent
stem cells without destroying human embryos.
I have the greatest sympathy for patients and their families who
continue to struggle with a wide range of fatal diseases. I understand
what it is like to watch a loved one suffer and the tragedy of losing a
member of your family--especially a young child. I lost my father to
diabetes and my young nephew C.T.--who was only 14--to bone cancer.
Like many here today, I have been a witness to the devastating effects
of Alzheimer's, arthritis, and many other debilitating diseases. That
is why I am sympathetic with my colleagues' efforts to seek out a
panacea. But I fear that too often proponents of embryonic stem cell
research make exaggerated claims about this line of research and offer
false promises when the evidence is just not there.
I read a great op-ed in The Washington Post by Charles Krauthammer--
who has long supported legal abortions and doesn't believe that life
begins at conception--in which he issued a stern warning against
pursuing embryonic stem cell research. As he said, he has a very
healthy respect for ``the human capacity for doing evil in pursuit of
good.'' And, that is exactly what I see happening in this Chamber
today. Too many of my colleagues are focused exclusively on embryonic
stem cell research, and they are missing potential that is right under
their noses.
I am reminded of Aesop's fable, ``The Stag at the Pool,'' in which a
stag stops at a spring to drink some water. He looks down at his shadow
reflected in the water and greatly admires the size and shape of his
beautiful horns, all the while thinking that his feet are too slender
and too weak. Just as he is looking at his reflection, a lion appears
at the pond. The stag sees the lion in the water and runs as fast as he
can to safety. As he enters the woods, though, his horns get tangled in
the tree branches, and the lion catches up to him. Finally, at that
moment, the stag realizes that it was his feet that could have saved
him and his antlers that led to his demise.
The moral of the story is: What is most truly valuable is often
underrated. I think the same is true on the subject of stem cell
research. We have been so focused on what we perceive to be the future
of medical research that we have been willing to overlook successful
treatments and therapies that are already taking place right under our
noses.
In light of all the advances and results science has provided with
adult and umbilical cord stem cells, I urge my colleagues to direct
Federal funding toward research that will have the greatest near-term
impact on human life.
Mr. KOHL. Mr. President, I rise today in support of S. 5, the Stem
Cell Research Enhancement Act of 2007, a bill that will expand the
number of stem cell lines eligible for federally funded research,
ensuring scientists at NIH and laboratories around the country have
access to new, uncontaminated stem cell lines.
Many families in America have experienced the tragedy of watching a
loved one suffer through a deadly or debilitating illness. Diseases
like Parkinson's and Alzheimer's take a terrible toll on families'
lives and livelihoods. While we have made great strides in biomedical
research in recent years, we still don't have all the keys to unlock
the secrets of disease.
That is why the potential of embryonic stem cells is so exciting.
Embryonic stem cells have the ability to develop into virtually any
cell type in the human body. Scientists tell us that harnessing the
power of these cells could one day lead to new treatments, and maybe
even cures, for a number of diseases that afflict American families.
Important research is being done every day on stem cells. I am proud
that some of this research is being done at the University of Wisconsin
in Madison, which was the first to isolate human embryonic stem cells.
We all understand that this research is not without controversy. I
respect the concerns that some people have about the use of embryonic
stem cells in research, and I agree that we must closely monitor this
research to ensure that it is done ethically. However, scientists and
disease advocates are warning us that the current limits on Federal
funding for stem cell research are seriously inhibiting our potential
to find new cures. Without expanded Federal support, we risk slowing
down the
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tremendous progress that could be made to alleviate human suffering.
It would be unconscionable for the Federal Government to turn its
back on the discoveries that expanding stem cell research promises. Now
more than ever, it is important to grasp this opportunity in an ethical
manner by making sure that potentially lifesaving research keeps moving
forward.
Mr. AKAKA. Mr. President, I am proud to be a cosponsor of S. 5, the
Stem Cell Research Enhancement Act. We must enact this legislation so
that researchers are able to move forward on ethical, federally funded
research projects that develop better treatments for those suffering
from diseases. Human embryonic stem cells have such great potential
because they have the unique ability in developing into almost any type
of cell or tissue in the body. Stem cell research holds great promise
to develop possible cures or improved treatments for a wide range of
diseases and injuries, such as diabetes, cancer, Parkinson's disease,
Alzheimer's, autism, heart disease, spinal cord injuries, and many
other afflictions. We must not limit research that could improve the
lives of so many suffering from diseases that we have limited ability
to prevent, treat, or cure.
In August 2001, the President implemented an unworkable, flawed
policy that made a small number of human embryonic stem cell lines
eligible. The President's restrictions on stem cell research prevent
Federal funds from being used for research on newer, more promising
stem cell lines. In addition, embryonic stem cell lines now eligible
for Federal funding are not genetically diverse enough to realize the
full therapeutic potential of this research. The President's stem cell
policy prevents researchers from moving ahead in an area of research
that is very promising. We must enact this legislation to help move
research forward that could alleviate the pain and suffering of
individuals.
If we fail to enact S. 5, our researchers are likely to fall further
behind the work being done in other countries. Australia, Canada,
Finland, France, Japan, Singapore, Sweden, and the United Kingdom have
provided substantial governmental support for stem cell research.
Too many of my constituents suffer from Alzheimer's, Parkinson's,
diabetes, and other diseases. S. 5 provides some hope for the
development of improved treatments that could improve the lives of so
many people.
Mr. McCAIN. Mr. President, I will vote in support of the two bills
under consideration today, S. 5 and S. 30, which would provide a
framework for Federal support of stem cell research under strict
guidelines and ethical criteria. I supported similar legislative
proposals during the last Congress.
Stem cell research has the potential to give us a better
understanding of deadly diseases and spinal cord injuries affecting
millions of Americans. One day, these efforts may lead to cures and
treatments for these devastating diseases and conditions. At the same
time, it is important and right to recognize the ethical and moral
concerns that have been raised by individuals inside and outside of the
medical research community regarding one particular type of stem cell
research that involves embryonic stem cells. I believe that these two
bills will provide an appropriate framework for moving stem cell
research forward in a responsible way.
We must create a framework for Federal support of stem cell research
now, since research involving embryonic stem cells is also proceeding
outside the United States. While we have had a robust and needed debate
on the ethical and moral concerns of embryonic stem cell research, as
reflected by the President's Commission on Bioethics, the same cannot
always be said of private industry and scientific research communities
in other parts of the world. I am deeply concerned where unregulated
research may lead us if researchers are left without ethical and moral
guidance and stringent regulations and oversight.
It does not have to be that way. One bill before us today, S. 5, is
similar to H.R. 810, a bill that I supported and that passed the Senate
on July 18, 2006. S. 5 will provide the same strict ethical guidelines
for stem cell research that the Senate supported last year. This bill
would authorize Federal support for embryonic stem cell research, but
limits appropriately that support to scientists who use embryos
originally created for reproductive purposes, and now frozen or slated
for destruction by in vitro fertilization clinics. Before there is even
consideration of whether to donate unused embryos for research, the
legislation would require that the patient who is the source of the
embryos be consulted and a determination be made that these embryos
would otherwise be discarded, and would never have been implanted in
the patient or another woman.
S. 5 also provides support for alternative stem cell research methods
by offering increased Federal funding and support for research that
does not involve the use of human embryos. Such alternative research
was unanimously supported in the Senate last July and deserves our full
support again today. Researchers believe that this type of stem cell
research holds tremendous potential and I strongly support their
efforts. Millions of Americans affected by many diseases and conditions
stand to benefit from the future cures provided by this type of
research.
I am also supportive of the other measure that is before us today, S.
30. This bill will also offer increase Federal funding and support for
adult stem cell research and other research that does not involve the
use of human embryos. Additionally, S. 30 would allow research to be
performed on embryonic stem cells taken from naturally dead embryos.
This research shows some promise but only additional research will tell
whether it can lead to cures and treatments, and we should embrace the
opportunity that would be afforded under this legislation to determine
the research potential that might exist.
The United States offers an ideal climate for scientific and medical
research because of the quality of our educational institutions, the
strength of our economy, and the scope of our comprehensive legal and
regulatory system for protection of intellectual property rights. The
guidelines and requirements contained in S. 5 do not exist currently,
and this sort of embryonic stem cell research remains largely
unregulated in the private sector and in many scientific communities
overseas. Enacting S. 5 would provide the Federal oversight necessary
to ensure that embryonic stem cell research does not expand into
ethically objectionable ground in balancing the promise on the
foreseeable horizon of stem cell research with the protection of human
life.
It should be clearly recognized that embryonic stem cell research
will occur with or without Federal approval and guidance. Keeping that
in mind, I believe embryonic stem cell research is best carried out
under strict Federal guidelines and oversight. With the limited Federal
support and stringent guidelines afforded under this legislation, we
can promote the benefits of stem cell research while maintaining
clearly our ethical and moral values and obligations, which we must
never sacrifice at any price.
Mr. LEAHY. Mr. President, I wish to express my support for the bill
before the Senate this week, S. 5, the Stem Cell Research Enhancement
Act of 2007. This legislation will put us on the path of progress by
reversing the President's policy a policy that is holding back the
promise of stem cell research.
It is unfortunate that the Congress must even spend time debating
this measure. The majority of Americans support stem cell research, as
does the Director of the National Institutes of Health, Dr. Elias
Zerhouni. It has been 6 years since the President announced his
administration's restrictive policy on stem cell research, which
limited the number of stem cell lines available for use with Federal
funding. Now we know that all of these lines are contaminated by the
use of mouse feeder cells, and they will probably never meet the
standards required for human treatment.
It is clear that, because of the President's policy, we are now years
behind in developing therapies and cures for diseases such as diabetes,
Alzheimer's and cancer. That is time that millions of Americans simply
do not have to waste. For millions of others, this wasted time has
dampened hope.
Some families who hold out hope for the potential of stem cell
research are from Vermont. Many are either afflicted by, or know
someone one who is
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suffering from, multiple sclerosis, Parkinson's or Lou Gehrig's
disease. I have met these Vermonters, many of whom are advocating not
for themselves, but for future generations who they hope will not
endure the debilitating nature of these diseases.
There are others in Vermont who know firsthand the good this research
could bring. These are the scientific researchers at the University of
Vermont and Dartmouth College who are doing groundbreaking work that
needs the support of our federal government to be truly successful.
These scientists know that the most viable method for progress in
research is to expand the number of embryonic stem cell lines that are
available.
I would like to take a moment to also address some of the myths
perpetrated about what S. 5 will and will not do. Let us be clear: This
bill will not allow Federal funds to be used for the destruction of
human embryos. While Federal dollars can be used for research on stem
cell lines that are derived from human embryos, the creation of these
lines cannot be funded with Federal moneys. S. 5 will do nothing to
change this policy.
This legislation will also ensure that Federal funding will be used
only for researching stem cells lines that are derived from human
embryos that have been donated from in vitro fertilization clinics. The
in vitro fertilization process creates more embryos than are needed,
and the remaining embryos will simply never be used. There are more
than 400,000 of these embryos that are frozen in fertility clinics, the
majority of which will ultimately be destroyed.
This week the Senate will vote on two stem cell bills. While I
support both, only one of these bills will take us solidly forward. The
time for passage of this legislation is now, and I urge the President
not to veto this critical bill.
I hope that the President will heed the advice of his own chief
medical researcher in the United States, NIH Director Dr. Zerhouni who,
when he testified before the Labor, Health and Human Services
Appropriations Subcommittee, said that American science would be better
served, and the Nation would be better served, if we let our scientists
have access to more cell lines.
As Congress is poised to send this legislation to the White House, I
hope the President will take note of Dr. Zerhouni's remarks. I hope
that he will also listen to Congress and the millions of Americans who
believe that we should support all angles in stem cell research, and
sign this bill.
Mr. DODD. Mr. President, I rise today in support of the Stem
Cell Research Enhancement Act. In the coming hours, the Senate will
vote to pass this bill like it did last year and unlock the door for
researchers across the country to use embryonic stem cells to better
understand diseases like Parkinson's and juvenile diabetes so that we
may one day find a cure. With each day that has passed since the
President vetoed this legislation, nearly 4,100 Americans were
diagnosed with diabetes, 3,800 were diagnosed with cancer, and 160 were
diagnosed with Parkinson's. What we are talking about here is research
that may one day provide relief to the more than 100 million Americans
suffering from Parkinson's, diabetes, spinal cord injury, ALS, cancer,
and many other devastating conditions for which there is still no cure.
The legislation we are about to vote on would expand the number of
embryonic stem cell lines available for federally funded research by
allowing the use of stem cells derived through embryos from in vitro
fertilization clinics that would otherwise be discarded. Strict ethical
requirements apply to the use of these stem cell lines. In fact, I
believe these ethical requirements are one of the most essential
provisions of the bill. Since the HELP Committee first began
consideration of the President's policy toward embryonic stem cell
research in 2001, I have maintained that the pursuit of scientific
research that may benefit millions of Americans and their families was
as important as ensuring that science did not outpace ethics.
Under this legislation, the only embryonic stem cells that can be
used for federally funded research are those that were derived through
embryos from in vitro fertilization clinics that were created for
fertility treatment purposes and were donated for research with the
written, informed consent of the individuals seeking that treatment.
Any financial or other inducements to make this donation are
prohibited. These embryos will never be implanted in a woman and would
otherwise have been discarded. The ethical requirements contained in
this bill are stronger than current law. In fact, it is possible that
some of the 21 stem cell lines approved for Federal funding, the so-
called ``NIH-approved lines,'' may not meet the strict ethical criteria
contained in this bill.
I have heard some of my colleagues who oppose this legislation argue
that this legislation allows, even encourages, taxpayer-funded
destruction of human embryos. That is totally false. There is a
provision called the Dickey amendment which is attached to every annual
Labor-HHS appropriations bill prohibiting any Federal funds from being
used to destroy human embryos. This provision is not affected by the
embryonic stem cell legislation before the Senate today. Federal funds
can be used to study stem cell lines that were derived from human
embryos that meet the ethical requirements I just laid out, but the
derivation process itself cannot be paid for with Federal money.
I have also heard some of my colleagues who oppose this legislation
argue that embryonic stem cell research is unnecessary given the
advances in adult stem cell research. There is no question that adult
stem cells such as those found in bone marrow and cord blood have led
to great advances in patients suffering from leukemia, Hodgkin's
disease, sickle cell anemia, among others. I was a coauthor, along with
Senator Hatch and others, of a bill that is now law to advance bone
marrow and cord blood stem cell collection for use in adult stem cell
transplantation, and I believe it is essential that we arm researchers
and physicians with every possible therapeutic weapon in their medical
arsenal. I urge my colleagues to join me in supporting full funding for
this important law, which passed unanimously in the Senate, in the
upcoming Labor-HHS-Education appropriations bill.
The fact remains that there will always be limits to the use of adult
stem cells when compared with embryonic stem cells, and that is why the
legislation before us is so important. Our Nation's best scientists,
including many Nobel laureates, believe that embryonic stem cell
research has a unique potential to ease human suffering and that is
because embryonic stem cells, unlike adult stem cells, can become any
cell in the body. Embryonic stem cells can become heart cells, lung
cells, brain tissue, and that property--called pluripotency--is unique
to their embryonic state.
The expansion of embryonic stem cell research may one day unlock the
mysteries behind so many deadly and debilitating diseases that afflict
millions of Americans and their families. I urge the President to
reconsider his position on this legislation and not stand in the way of
our Nation's scientists who simply want to find the key that will ease
the burden of suffering.
Mrs. CLINTON. Mr. President, I welcome the vote on this important
piece of legislation, the Stem Cell Research Enhancement Act of 2007.
Stem cell research holds great hope of providing cures for chronic,
incurable conditions from which millions of Americans suffer. But
unless we act, the Bush administration will continue to meet this
unparalleled moment of scientific discovery with unbridled ideology--
and the American people and scientific community will pay the price.
The President's stem cell ban amounts to a ban on hope for millions
of Americans. It's time this Congress put an end to the Bush
administration policy which is holding science back and holding our
Nation back in the race to new medical treatments and discoveries.
We all expect that this bipartisan legislation will pass both the
Senate and the House. There is a broad consensus in the Congress, among
medical experts, scientists, and patient advocacy organizations, and
among the American people, demanding that we open the doors to
scientific innovation--instead of barring those doors shut.
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Even within the Bush administration, there is a desire to pursue stem
cell research. The Director of the National Institutes of Health,
Doctor Elias Zerhouni, has gone on record supporting expanded access to
new lines of embryonic stem cells.
I am deeply concerned, however, that we have been down this road
before a road that begins with the promise of new cures and ends, not
with discovery, but with ideology and a veto by the President.
The promise of stem-cell science is crystal clear--and already being
demonstrated. Embryonic stem cells develop into a variety of more
specialized types of cells--like nerve cells or muscle tissue that
could be used to replace or repair tissue lost or damaged from illness.
In New York, researchers at Memorial Sloan-Kettering Cancer Center
have been using embryonic stem cells to develop bone, cartilage or
muscle replacement therapies. And in 2006, a team of researchers from
Columbia University and another team from Cornell published research on
new ways of turning embryonic stem cells into treatments for
Parkinson's disease.
These are just several examples, but the work of these scientists and
scientists around the world is inspiring hope for millions in New York
and the country living with chronic diseases, or caring for a loved one
with these conditions.
In fact, New York is leading the way--letting science, not politics,
guide research. My State will soon invest $600 million in stem-cell and
regenerative medicine research over the next decade. Thanks to this
stem cell funding plan, New York researchers will benefit from expanded
resources for all types of stem cell research, including embryonic stem
cells, adult stem cells, and somatic cell nuclear transfer. And our
economy will benefit as well, as we draw great American scientists and
innovators pursuing the next great American scientific innovations.
This is encouraging news for New York, but as a Nation, the
leadership vacuum under the Bush administration has left the scientific
community holding its breath. The Bush administration has put a ban on
certain kinds of research, prohibiting Federal funding for any research
on stem cell lines created after August 9, 2001.
Federally-funded scientists are limited to less than 20 stem cell
lines, instead of the 78 lines advertised. And not all of these lines
are even suitable for research. Some may be contaminated with mouse
cells, which can increase the risk of creating strains of diseases
which can more easily pass to people. Other problems because of the ban
include genetic instability, which is associated with formation of
tumors, and practical issues associated with using so few lines--
preventing scientists from collecting evidence they need.
While American scientists are being held back, other countries are
racing ahead, putting billions of dollars into stem cell science--
creating research institutions, clinical centers, and investments of
all kinds to attract scientists from the United States and elsewhere
who will come to pursue this research.
We are losing ground instead doing what Americans do best: leading
the world in innovation, ingenuity, and new ideas. The Bush
administration's stem cell policy is impeding science and compromising
America's ability to remain at the forefront of biomedical research.
At the same time, the Bush ban is a ban that affects more than 100
million Americans who suffer from Alzheimer's disease, Parkinson's
disease, diabetes, muscular dystrophy, cancers as well as for their
friends, families, and caregivers.
These are real people I meet every day in New York and across the
country. It's an adult with type I diabetes--or a mom whose son or
daughter has the disease. It's a senior citizen struggling with
Parkinson's disease or a son or daughter with a parent struggling with
Alzheimer's.
These are Americans crossing every divide imaginable--hopeful if not
for themselves or their children, then for their grandchildren and
great grandchildren. My dear friends Christopher and Dana Reeve, whom
we lost in the past several years, were eloquent, passionate advocates
for this research. Christopher, from his wheelchair, performed his
greatest role after his accident, to try and bring the best of American
ingenuity to bear on the worst kinds of illnesses and diseases.
I respect my friends on the other side of the aisle who come to the
floor with grave doubts and heartfelt concerns. This is a balancing act
and we must never lose sight of our ethics and values. But we can
strike that balance--and I believe we have in this bill.
When the promise of embryonic stem cell research became apparent in
the 1990s, the Clinton administration, working through the National
Bioethics Advisory Commission and the NIH, examined the ethical and
medical issues involved with such research.
In September 1999, the National Bioethics Advisory Commission
released its report, ``Ethical Issues in Human Stem Cells Research.''
In this report, it recommended that research using cells from embryos
created, but not used for, infertility treatment, should be eligible to
receive Federal funding.
By August of 2000, the NIH had released guidelines for research using
stem cells. These guidelines would have allowed funding for research
from lines derived from embryos voluntarily donated which would have
otherwise been discarded. These recommendations are followed in this
bill, which also includes funding for non-embryonic stem cell research,
such as work with stem cells derived from amniotic fluid.
As we wade into these new scientific waters, we must always be
steered by our values and morals, which is why I have stood against,
and voted to ban, human cloning. We must make a strong legal and
ethical stand, but we cannot simply stand still as scientific
opportunity passes us by and new cures remain just out of reach.
I applaud the leadership of Senators Harkin, Specter, and Kennedy on
this bill. I am hopeful that we can send the Stem Cell Research
Enhancement Act to the President, and end the ban on research and hope
for Americans looking to us to fund the next great medical discoveries.
Mr. FEINGOLD. Mr. President, as we debate this important legislation
regarding stem cell research, we are reminded of the millions of
patients and families across America who await treatment and cures for
our most deadly and tragic diseases. Scientists believe that over half
of Americans over 85 may suffer from Alzheimer's disease, and at least
half a million Americans currently have Parkinson's disease. People of
all ages suffer from spinal cord injuries, diabetes and other chronic
conditions. As we all know, these kinds of serious diagnoses affect not
only the patient, but that patient's family, friends, and community.
I am a strong supporter and proud cosponsor of the Stem Cell Research
Enhancement Act. I have heard from many of my constituents in Wisconsin
in support of this legislation, and I am glad that the Senate is again
addressing this issue and responding to the requests of millions across
the country. It is important that we approve this legislation as
expeditiously as possible, and provide the resources that scientists
need to develop treatments and cures for these diseases. Millions of
patients and their families across the Nation cannot afford to wait any
longer for enactment of this urgently needed legislation.
Researchers believe that they can unlock enormous potential in stem
cell research if Congress and the President will only give them the
keys. At the University of Wisconsin in 1998, Dr. James Thomson became
the first scientist to break into this new frontier by isolating human
embryonic stem cells. Since then, researchers at the University have
continued to be leaders in this science. But despite the incredible
promise this research holds, it has been limited by the President since
2001. As others have noted, even Story Landis, director of the NIH's
National Institute of Neurological Disorders and Stroke and interim
chair of the agency's stem cell task force, acknowledges that the
President's stem cell policy is holding back potential breakthroughs.
Congress must act to provide more stem cell lines to scientists so that
this research can go forward, without the Federal Government standing
in the way.
The Stem Cell Research Enhancement Act would allow federally funded
[[Page S4355]]
research to be conducted on stem cell lines derived from excess embryos
originally created for in vitro fertilization--IVF--that are no longer
needed and are donated by couples for research. It is estimated that
there are hundreds of thousands of embryos created for fertility
treatments that could be used for research and will otherwise be
destroyed. This bill does not interfere with alternative stem cell
research, but it supports all avenues of research within the ethical
limits Congress has already established. This bill will open doors for
scientists to access new, healthy, uncontaminated stem cell lines that
are currently off-limits to federally funded research under President
Bush's restrictions.
The embryos that could potentially be used for research are those
that will never be implanted. Thanks to this legislation, embryos that
would otherwise be discarded could be used for research that could save
pain and suffering for millions of people, and the lives of millions
more.
While I support the Stem Cell Research Enhancement Act, I have
concerns about the other bill we are considering today, S. 30. The
language in that bill has not been properly vetted through the
scientific community, and it is unclear what effect it might have. S.
30 could potentially limit the scope of current research, even further
restricting the availability of stem cells for federally funded
research. For these reasons, I oppose this legislation.
There is much work that needs to be done to further understand the
role that embryonic stem cells can play in providing answers to some of
the most troubling medical diseases and conditions that affect so many
Americans. The Stem Cell Research Enhancement Act will help our
Nation's researchers get closer to unlocking what this research holds
by increasing the quantity and quality of stem cells lines available
for research.
Embryonic stem cell research is very important to me and to
Wisconsin. I am proud that the University of Wisconsin has played a
prominent role in stem cell research in this country. I know that my
constituents, and Americans across the country, are eagerly awaiting
the benefits that this research will provide.
I hope my colleagues will join me in supporting this incredibly
important science which would expand our research horizons, and bring
hope to so many people.
Mrs. FEINSTEIN. Mr. President, I rise in opposition to the Hope
Offered through Principled and Ethical Stem Cell Research Act, S. 30.
My objection to this bill is simple. This legislation will do nothing
to overturn President Bush's failed policy that is restricting access
to viable stem cell lines.
The United States Senate must be very careful when incorporating
scientific concepts, and scientific definitions, into legislation. This
bill relies on the notion of so-called ``naturally dead'' embryos to
provide viable stem cells. It defines these embryos as:
having naturally and irreversibly lost the capacity for
integrated cellular division, growth, and differentiation
that is characteristic of an organism, even if some cells of
the former organism may be alive in a disorganized state.
We do not know what the implications of this definition may
ultimately be. And the fact is, neither do many scientists. As the
leadership of The American Society for Cell Biology wrote yesterday,
Naturally dead is a scientifically meaningless idea. To our
knowledge, there is no scientifically credible way to
determine this.
They continue:
It is critically important that the Senate proceed with
caution as it continues its work in the area of scientific
policy. Legislation based on inaccurate science could have a
detrimental impact on the course of the American biomedical
research enterprise.
I ask unanimous consent that this letter be printed in the Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.).
Mrs. FEINSTEIN. I could not agree more. This debate should be about
providing Federal funding, and a consistent policy, for embryonic stem
cell research. It is not the place of the U.S. Senate to rely on
concepts and definitions that are ``scientifically meaningless.''
The truly important vote will occur on the passage of S. 5, the only
legislation that will reverse what the majority of Americans, and the
majority of the medical and scientific community believe to be a flawed
policy.
S. 30 will very clearly leave in place President Bush's August 9,
2001 Executive Order, which limits Federal funding to stem lines
derived before that date. We need to overturn this policy, not affirm
it.
I urge my colleagues to join me in opposing S. 30.
Exhibit 1
The American Society for
Cell Biology,
Bethesda, MD, April 10, 2007.
Hon. Harry Reid,
Senate Majority Leader, U.S. Senate,
Washington, DC
Dear Senator Reid: We would like to express our views about
the upcoming Senate debate on stem cell research, as the
President and Public Policy Committee Chair respectively for
the American Society for Cell Biology. Our nonprofit,
professional society of more than 11,000 members includes
many of the leading scientists working in this area.
As you know, it is critically important that science policy
be carefully crafted to allow ethically sound scientific
research to proceed. This is particularly difficult to do
when the science behind the policy is as complicated as in
the current policy debate on stem cell research.
We are particularly concerned about a major provision of
S.30, the ``Hope Offered through Principled and Ethical Stem
Cell Research Act.'' The expressed purpose of S.30 is to
``promote the derivation of pluripotent stem cell lines
without the creation of human embryos for research purposes
and without the destruction, discarding of, or risk of injury
to a human embryo or embryos other than those that are
naturally dead.''
S.30 relies on the false premise that scientists can
determine whether a human embryo is ``naturally dead.''
However, naturally dead is a scientifically meaningless idea.
To our knowledge, there is no scientifically credible way to
determine this. In fact, we think that to establish
sufficiently precise scientific or clinical standards about
the quality of embryos at the very early stages of
development would require experiments that the bill itself
would not permit.
It is critically important that the Senate proceed with
caution as it continues its work in the area of science
policy. Legislation based on inaccurate science could have a
detrimental impact on the course of the American biomedical
research enterprise. Not only do we risk driving research and
researchers to other countries more interested in cutting
edge research but we also delay the day when our fellow
Americans who suffer from some of the most debilitating
diseases finally realize the benefits of scientific
research.
Sincerely,
Bruce Alberts,
President.
Larry Goldstein,
Chair, Public Policy Committee.
Mr. DURBIN. Mr. President, today we made an important step forward
for the hope of millions of patients and their families.
Unfortunately, with this important step forward, there was also a
small step backward.
I had initially stated that I would vote in favor of S. 30, but after
carefully reviewing the language, I decided to vote against it.
I will ask to have printed in the Record a letter from the Joint
Steering Committee on Public Policy that supports S. 5 and opposes S.
30.
The Joint Committee is a group made up of the American Society for
Cell Biology, the American Society for Clinical Investigation, the
Genetics Society of America, Science Service, and the Society for
Neuroscience.
Many of us here believed that S. 30 was a harmless bill.
After all, it is an initiative that would show we are supportive of
all forms of embryonic stem cell research.
And I believe that some still feel that way.
But after hearing from a variety of research organizations and
scientists, I have serious reservations.
After carefully reviewing the legislation, it is now clear that S. 30
sends the wrong message to the scientific community.
S. 30 puts forth a number of scientific issues that negatively
position the scientific debate around what constitutes life and death
and raises concepts that may not even be scientifically defined.
As elected officials discussing complex science issues, we are
already in somewhat unfamiliar territory.
If we are to delve deeper into this discussion and the details of it,
we need the scientific community on our side.
I stand for the advancement of medical research and I hope that this
vote has made it clear.
[[Page S4356]]
Mr. President, I ask unanimous consent to have the aforementioned
letter printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Joint Steering Committee
for Public Policy,
Bethesda, MD, April 9, 2007.
Hon. Harry Reid,
Senate Majority Leader,
U.S. Senate, Washington, DC.
Dear Senator Reid: On behalf of the Joint Steering
Committee for Public Policy (JSCPP), I would like to express
our support for S. 5, the ``Stem Cell Research Enhancement
Act of 2007.'' S. 5 would expand the current federal policy
regarding federally funded embryonic stem cell research to
allow the use of cells derived since August, 2001, from
embryos originally generated for reproductive purposes that
would otherwise be destroyed.
I would also like to express the JSCPP's opposition to S.
30, the ``Hope Offered through Principled and Ethical Stem
Cell Research Act.'' The purpose of S. 30 is to ``promote the
derivation of pluripotent stem cell lines without the
creation of human embryos for research purposes and without
the destruction, discarding of, or risk of injury to a human
embryo or embryos other than those that are naturally dead.''
S. 5 represents an important step forward for human
embryonic stem cell research, a new field that offers great
promise for the replacement of damaged cells, the
understanding of the mechanics of disease, and the
development and testing of new drugs. Unfortunately, current
federal policy, in place since 2001, has not kept pace with
the speed of scientific discovery and is today of limited
value to the scientific community, a position endorsed by the
Director of the National Institutes of Health, Elias
Zerhouni, at a recent Senate appropriations hearing.
While the JSCPP is supportive of S. 5, we strongly oppose
S. 30. S. 30 is proposed as an alternative to S. 5, but
contains no substantial measure to reverse current
limitations on embryonic stem cell research and simply
endorses research avenues that are already open under current
law. We oppose the bill because it contains unnecessary
provisions and places confusing and short-sighted
restrictions on biomedical research.
The prohibitions in S. 30 against the use of government
funds to derive stem cells with methods that generate embryos
for research purposes or that involve the destruction of
embryos are unnecessary, because the annual Departments of
Labor, Health & Human Services and Education Appropriations
bill has, for many years, included the same prohibitions.
Furthermore, the central provision of S. 30 appears to
allow research on embryos considered to be ``naturally
dead.'' We are particularly concerned about this requirement
because the term ``naturally dead'' is not a scientific term,
and there are no scientific or clinical standards for
determining the quality of embryos at the early stages of
embryonic development.
We are also concerned about the provision in S. 30 that
requires a priority to be placed on research ``with the
greatest potential for near-term clinical benefit.'' Not only
is it impossible to know the benefits of research in advance,
but limiting the scope of research in this way places a
muzzle on the scientific process, placing short-term
incremental advances ahead of the more challenging goals of
preventing or curing diseases such as diabetes.
For these reasons, we believe that passage of S. 30 would
be a significant step backwards for human embryonic stem cell
research and for biomedical research in America. Therefore,
we urge a ``yea'' vote on S. 5 and a ``no'' vote on S. 30.
Sincerely,
Harold Varmus, MD,
Chair, Joint Steering Committee
for Public Policy.
Mr. ISAKSON. Will the Presiding Officer give us the allocation of
time remaining?
The PRESIDING OFFICER. The Senator from Iowa has 31 minutes
remaining.
Mr. ISAKSON. Thirty-one minutes?
The PRESIDING OFFICER. Thirty-one. The Senator from Kansas has 25
minutes. The Senators from Minnesota and Georgia have 45 minutes.
Mr. ISAKSON. With all due respect, Mr. President, we reached an
agreement at the end of the previous time that we would equally divide
2 hours 30 minutes between Senator Harkin, Senator Brownback, Senator
Coleman, and Senator Reid. We are in the fourth of those 30-minute
blocks now, which would be ours, and then we go to four 10-minute
blocks equally divided; is that correct?
I believe I am correct. How much of our time do we have left of the
30-minute block?
The PRESIDING OFFICER. Forty-five minutes for the Senator from
Georgia.
Mr. ISAKSON. Mr. President, I am pleased to yield 10 minutes to the
distinguished Senator from Oklahoma, Mr. Coburn.
The PRESIDING OFFICER. The Senator from Oklahoma.
Mr. COBURN. Mr. President, I listened with interest to the Senator
from New York. As a practicing physician and somebody who has delivered
over 4,000 children, I cared for both toddlers and young adults with
type 1 diabetes. There is nobody who doesn't want to see that disease
fixed. The problem is, we shouldn't promise things we don't know are
accurate.
What we do know is that yesterday on CNN, an article was released
from JAMA showing the treatment of 13 young Brazilians who had type 1
diabetes who are now free from using exogenous insulin. They are on no
medicine whatsoever and their sugar is totally controlled. That is one
step going forward in all the areas of medicine.
The other comment I will make before I make my final points is, if
you talk to anybody in the area of research on Alzheimer's--
Alzheimer's, and we heard it time and time again, is a devastating
disease for individuals who have it, and it is a devastating disease
for families who care for their loved ones with it--I don't know of
anybody in embryonic stem cell research or in research in medicine by
themselves who has great hopes for a cure of Alzheimer's with embryonic
stem cells. We have heard that claim time and time again. It is not a
great hope for Alzheimer's. There is hope. There is beta secretase,
which is an enzyme that causes Alzheimer's to be laid down. There are
great medicines coming forward. Some are in trials in primates right
now that tend to stop Alzheimer's in its tracks.
We ought not to be promising things we don't know or are not
realistic in terms of Alzheimer's. That is the case.
I want to sum up where we are, the differences between the two bills.
One bill, S. 5, has lots of positives in it. We hear it is not going to
destroy any other embryos, there is going to be a grandfather of the
embryos that have been created since. We heard the Senator from New
York say something different. We heard the Senator from California
yesterday talk about the 400,000 embryos that are frozen today, of
which only 2.8 percent are available and less than that number--so less
than 250 lines--could totally be created out of all the embryos that
are available in this country today.
The answers are kind of sleight of hand. To have an effective
embryonic stem cell program, other than what is provided in S. 30,
means we are going to use Federal taxpayer dollars, indirectly or
directly, to destroy embryos. You can say you are not, but the fact is
that will happen.
What are the positives of S. 30? The positives of S. 30 are that it
looks at everything. It looks at all the new and upcoming methods. One
is altered nuclear transfer. No. 1, you don't destroy any embryo, you
don't create an embryo, but yet you get identical cells to what an
embryonic stem cell would be, totally pluripotent, totally capable of
doing everything an embryonic stem cell can do.
Why is there resistance to that? Why would there be any resistance to
that? There shouldn't be.
The second point is what we call germ cell pluripotent stem cells.
Those are made from the testes and ovaries of us, each of us, and we
can have treatments designed for ourselves. Every tissue type in the
body has now been produced from germ cell pluripotent stem cells,
either ovarian or testicular, again, applying the same pluripotent stem
cells you get from an embryo, but you never destroy a life.
My friend from Minnesota, one of the coauthors of this bill, makes a
great point. Whatever happens at the end of the day--right now this
glass of water represents what is happening on embryonic stem cell
research with Government funds in this country. There is a whole lot of
other research going on with embryonic stem cells outside the
Government. It has not dead stopped. As a matter of fact, it is
advancing forcefully without Government money. But this represents what
is there. If S. 5 is passed out of this body and the House, this is
what we will see next year: the same amount, because this bill is going
to be vetoed.
However, if S. 30 is passed, what we will see is this much research,
a doubling of the research next year. So one says help people play the
political game when we know it is going to be
[[Page S4357]]
vetoed. S. 30 says let's do something real. Let's give an answer to the
hope. Let's double it up and let's do it in a way that is an ethically
good way.
The final point I wish to make is to anybody who wants us to do
embryonic stem cell research, anybody who has a family member with a
chronic disease, anybody who has a child with diabetes, anybody who has
any need that has hope coming from ``embryonic stem cell research,''
the question I put forward to them is this: If we can show you the
science is going to give us exactly the same results with never
destroying an embryo, what would your choice be--destroy an embryo and
get the results or do not destroy an embryo and go one of the multitude
other ways to accomplish exactly the same purpose?
That is the real question that is facing this body. That is the
question the American people ask. The science is 2 to 3 years ahead of
the debate in this body today.
A lot of times my colleagues accuse me of not making much sense on
the floor when I talk about these issues because it is a medical issue,
it is a scientific issue. I am a doctor. I understand the science, so I
tend to not use the words as plainly as I should. But the
ethical question still arises: Do you want a doubling of the research
to go forward and answer the very human need that is out there or do
you want to play the political game and have exactly what we have
today?
I say to Senator Harkin, that is what will happen if S. 5 goes
through. It is going to be vetoed. It will not be overridden in the
House. Or we can have S. 30 that does as much or more than S. 5 and we
will see a difference for the American people.
The hope my colleagues talk about will be realized when S. 30 gets
passed, when S. 30 gets signed. The President has said he will sign it.
It makes available everything we will need and still accomplishes the
same goals but does it twice as fast. That is the real question: Do we
want to play politics with this issue? Do we want to say somebody's
legitimate position of valuing life, that they have an illegitimate
position because they value life at the expense of somebody with
chronic disease, or can they value life, come with an answer that
actually accomplishes the same purpose in a better timeframe with
better results with S. 30? That is the real question for us.
I understand the political game we are playing. I understand the
diseases. But when you read the basic raw research that is going
forward today, we are not even close to what is happening, we are not
even talking about what is happening out there.
Final point. Make sure you understand that if you believe in
embryonic stem cell research as a viable ethical alternative, you also
have to believe in cloning because the only way you will get a
treatment that is good for you without rejection, without rejecting the
very treatment that is being given to you, is for you to clone
yourself. That is the dirty little secret nobody wants to talk about in
this debate because once we accomplish with true embryonic stem cells
versus altered nuclear transfer, any treatment will require
antirejection drugs or you having to clone yourself.
The language is very specific. There is no cloning as far as
implanting into a uterus, but it doesn't mean you don't clone yourself
and destroy yourself to meet a need for you.
It is a very complicated ethical issue about which we ought to be
very clear. It is not just destroying embryos. It is going the next
step now to have an effect from that treatment.
I believe there will be good treatments come out of embryonic stem
cell research. I don't have any doubt about that. I believe exactly
those same treatments will come and be better from altered nuclear
transfer, from dedifferentiation, which is a term that says you take a
cell that is more mature and dedifferentiate it back to a pluripotent
cell, or from germ cells, either ovarian or testicular.
We can accomplish the desires of everybody who is hurting in our
country today who has a hope and do it in a realistic way with S. 30
that will deliver the goods, deliver taxpayers' dollars to make a
difference. S. 5 will deliver nothing, nothing for at least 2 years,
because this President won't sign it.
So the consequence and the question that comes back to us is: Are we
going to do something that is meaningful or are we going to play the
political game that in the long term has no meaning, at least for the
next 2 years?
I yield back my time to the Senator from Georgia.
Mr. ISAKSON. Mr. President, I thank the Senator from Oklahoma.
I yield up to 15 minutes of our time to the distinguished Senator
from Minnesota, Mr. Coleman.
The PRESIDING OFFICER. The Senator from Minnesota.
Mr. COLEMAN. Mr. President, I thank my colleague from Oklahoma, who
brings a physician's perspective. We hear so often on the floor of the
Senate that we need to look in the eyes of young kids with juvenile
diabetes and say: Are we doing all we can do? My colleague from
Oklahoma has dealt with that on a regular basis. He stands with me, and
I thank him for his support.
In the end, there is a practical conclusion, as he demonstrated with
the glasses of water. If you want an answer, if you want to look those
kids in the eyes, talk to the families of folks with ALS or heart
disease, if you support S. 30, you can look them in the eye and say:
Today I have done what I can do to move the science forward, to have
additional Federal support for embryonic stem cell research but
research which, in the end, is unifying research.
Dr. William Hurlbut, who is one of the authors of a technique known
as altered nuclear transfer, used a phrase that I borrowed. It is an
island of unity and a sea of controversy. That is what S. 30 offers, an
island of unity and a sea of controversy. There is disagreement in this
country about the use of Federal dollars for the destruction of a human
embryo. That is a reality. In the end, scientific advancement should be
something that is unifying. It shouldn't be tearing this country apart.
You shouldn't worry, if you are going into a hospital for some kind of
treatment, whether there is some moral line that has been crossed for
you as an individual. You shouldn't have to do that. We shouldn't put
people in that position.
The good news is we don't have to. It is fascinating. I think the
science has gotten ahead of the politics. I have no doubt, as I
listened to this debate, these are people of good will on both sides of
this debate, supporting both proposals, but I believe the same ultimate
kind of vision to improve quality of life, to enhance scientific
research, to put an end to debilitating and threatening disease and
illness, is the kind of common bond we have, people of good will.
I suppose a number of years ago, individuals of good will, good moral
background, religious background, may have come to a conclusion that
they would support the destruction of a human embryo for the
opportunity to do good today for someone who is here. It is a line some
of us can't cross. We bring deeply held moral perspectives to this
issue. I understand others of good faith and strong character, solid
religious background and belief, say this is the line, this is the
right thing to do.
I heard my colleagues on the other side quote scriptures and pastors
and others--my friends, of good will, and good heart. In the past, that
may have been the only path to where we wanted to go.
The Clinton administration looked at this. In fact, this is the
language they used. In 1999, President Clinton's National Bioethics
Advisory Commission issued a report entitled ``Ethical Issues in Human
Stem Cell Research'' acknowledging that a week-old human embryo is a
form of human life that deserves respect. The Commission stated:
In our judgment, the derivation of stem cells from embryos
remaining following infertility treatments--
These are the embryos we are talking about here, IVF--
is justifiable only if no less morally problematic
alternatives are available for advancing the research.
Science has moved ahead of where we were in 1999. I was on the phone
a little while ago with a Dr. Landry from, I believe, Columbia
University. Dr. Landry talked about a stem cell line coming from dead
embryos that has all the capacity, pluripotency of the stem cell lines
from fertility clinics. So a ``less morally problematic alternative''
is available.
My friend and colleague from Georgia, the coauthor of this
legislation,
[[Page S4358]]
knows from Georgia experience that scientists worked on dead embryos. I
thought about it, and I believe it is part of the 21 lines the
President authorized for embryo research. The work is being done. The
reality is there are cell lines available today that are not eligible
for Federal funding. That is because we have a policy that says no
Federal funding for embryo stem cell research. But if we pass S. 30,
and S. 30 gets signed into law, then we have available Federal funding
for embryonic stem cell research that would not be available today.
That is then ``morally less problematic'' because it does not involve
the destruction of a human embryo.
When we talk about a dead embryo, my colleague from Georgia has done
a very good job. My colleagues may have said: It is a dead embryo. What
can you get out of a dead embryo? Let me explain two concepts. They are
at the heart of this debate. I am not a scientist, but I have learned a
lot about pluripotency, the capacity of a cell to give rise to many
different cell types. Embryonic stem cells, those that have come from
in vitro fertilization clinics, they have pluripotency. They have this
elastic capacity to recreate any kind of cell. So maybe sometime in the
future you can create stronger heart muscles. Today, in fact, with some
types of stem cell research, that is being done. Maybe you can grow
limbs. Maybe you can cure ALS. There is an incredible capacity,
pluripotency.
There is also this concept of totipotency. Totipotency is the
capability of a zygote or other cell to develop into a complete,
integrated human being. The line we are talking about today between S.
5 and S. 30 is the line between pluripotency and totipotency. We all
support research that will provide for pluripotent stem cells,
pluripotent cells that have the capacity to be almost anything.
The dividing line, though, is whether you have totipotency, so with a
human embryo, cells that are involved in a fertility clinic--I am going
to switch charts and talk about a couple of other techniques that
involve pluripotency but not totipotency. What we look at with dead
embryos are cells that are pluripotent. I don't know if it is a great
analogy, but even after death we can harvest organs that have the
ability to serve the function you want them to serve. So dead embryos
are embryos that have no totipotency but have pluripotency. You get
pluripotent cells.
The other approach is an approach known as altered nuclear transfer.
That, by the way--I say ``the approach.'' There are a number of other
approaches out there. My colleague from Oklahoma talked about that. I
think he talked about dedifferentiation, talked about germs--there are
a number of different procedures and techniques that have strong
scientific support that allow us to produce pluripotent cells without
totipotency. They allow us to produce embryonic stem cells that have
all the capacity for research that gives the hope we are talking about
without creating a human embryo that does not involve, then, the taking
of human life; that does not involve the moral line that many Americans
feel is there.
Not all. There is a difference in this. That is why I am saying, what
S. 30 does is it gives us this island of unity in the sea of
controversy. What it does is allow all of us--and I do hope all my
colleagues, wherever you are on this issue--support for S. 30. Why
would you be opposed to Federal funding for embryonic stem cell
research that advances us?
My colleague from Oklahoma used the two glasses of water. If you
support S. 5, all you are going to get tomorrow--in January 2008, S. 5
passes. It passes in the Senate, passes in the House, it is vetoed. We
have this much right now--I believe it is about $130 million. That is
what this glass represents in research, embryonic stem cell research.
Those are the 20-something lines left the President authorized.
In January of 2008 you are going to get $132 million of federally
funded stem cell research. But if we pass S. 30, what we have then is
the opportunity for research in a range of other areas, perhaps
doubling and maybe more--I would hope much more--of stem cell research,
or pluripotent stem cells, to get the capacity to do all the treatments
and provide the hope.
We are, by the way, a long way away in reality from human treatments,
but it is hope. That is what this bill is, this is the HOPE bill.
One of the other mechanisms we talked about is altered nuclear
transfer. Just to explain, in the natural fertilization process,
biology 101, you have the sperm, you have the egg, you get the
fertilized egg, and you get the embryo.
In the clone what you have is the egg cell, you enucleate it--you
take out the center. This may come from a fingernail or skin, whatever,
a cell with all the DNA, and you insert it into this enucleated egg.
You activate it and then you get an embryo. I think that is the way
Dolly the sheep came about.
By the way, my colleague from Oklahoma talked about this. If we are
going to do stem cell research from here, and we are going to take this
embryo and we are going to create stem cells and we put that into you
or me, you are going to have an immune reaction, and your whole life--
if you put this in you, you are, for your whole life, going to have to
deal with immune reaction suppression and the drugs. The only way
around that is the Dolly approach. If you create stem cells from your
own cells there is no immune reaction.
We are not talking about that, although there are those of us who
raise the concern: How do you get ultimately where you want to go
without that possibility?
Another way is the altered nuclear transfer. You take the genetic
material, the somatic cell, fingernail or something, and what you do
before you insert it into this enucleated egg is touch off a trigger
mechanism that shuts off the ability to create the embryo, but it still
creates an inner cell mass with pluripotent cells--the capacity of a
cell to give rise to many different types of cells. Do all the research
you want.
So S. 5 provides funding for new stem cell research. It provides the
opportunity to do all that one wants to do without crossing the moral
line. Why wouldn't we get there?
My great fear is that what will happen this year is what happened
last year. In the Senate there was a bill, the Specter-Santorum bill,
which, by the way, did not provide for all that we have in S. 30. It
did not provide for the dead embryo research. I think it may have
provided for some sort of ANT. The good news is that is included in S.
5, but S. 5 is going to be vetoed so that doesn't go anywhere.
Last year that passed, 100 to 0, a bill with some alternative
measures. But, again, we have gone way beyond last year, this year, in
terms of the science.
The House refused to hear it. They took an all-or-nothing approach:
If you don't support the destruction of a human embryo to do stem cell
research we are not passing anything. Where is the hope in that? As you
look at this I challenge my colleagues on the other side of the aisle
to tell their colleagues in the House: Give hope, the hope we have
talked about on this floor, the hope we all agree on, the hope that
there is just consensus on that we want to move the research forward.
Do not let some kind of politics that I cannot understand stop us from
moving forward with the opportunity to move research that can produce
hope.
There are many scientists who have kind of said: Yes, we looked at
ANT and we know it can work and we need to put our efforts into that. I
will read a couple of quotes:
Research results suggest that altered nuclear transfer may
be able to produce human pluripotent stem cells--in a manner
that is simpler and more efficient than current methods.
That is by Hans Scholer, chair of the Department of Cell and
Developmental Biology at the Max Planck Institute in Germany.
Recently, multiple labs in the United States and from
around the world have published or reported experiments in
which adult cells were converted not to embryos but directly
to pluripotent embryonic-like cells. The resulting cells were
virtually indistinguishable from embryonic stem cells derived
from embryos. The techniques used included altered nuclear
transfer, cell fusion and chemical reprogramming. The results
were obtained from top scientists in the field and published
in the best journals.
That was by Markus Grompe, M.D., Oregon Stem Cell Center.
It is fascinating, those scientists that support just embryonic stem
cell research without anything, they will tell
[[Page S4359]]
you nothing else works; this is the whole ball of wax; my way or the
highway. Then you have scientists who support these alternatives who
say: Yes, this is the best way to go.
Maybe it is about Federal funding. Maybe if you don't believe your
way is the only way you are not going to get Federal dollars. We have
to get past the politics. We have to get past the petty scientific
divisions and simply look at what we have out there and embrace and
seize the opportunity to move forward in a way that is cohesive, that
gets this Nation outside of the culture wars, outside of the battles
over Federal funding for the destruction of human life. Put it aside.
We don't have to go there today. Science is offering us a better path.
The PRESIDING OFFICER (Mr. Brown). The time of the Senator has
expired.
Mr. COLEMAN. I urge my colleagues to take a look at S. 30, regardless
of where you are on S. 5. This is a bill that deserves unanimous
support. In the end, let's work on our friends and colleagues in the
House to pass the law so that we have, in the end, one the President
will sign, one which offers and delivers true hope.
I yield the floor.
Mr. ISAKSON. How much of our time remains?
The PRESIDING OFFICER. The Senator from Georgia has 17 minutes.
Mr. ISAKSON. I will acknowledge, given the agreement we previously
made, I think I will only take 5 of those. I recognize myself for 5
minutes.
The PRESIDING OFFICER. The Senator from Georgia is recognized.
Mr. ISAKSON. I acknowledge the patience of the Presiding Officer. I
know the Presiding Officer was in the chair last night when the Senator
from Iowa and I had an exchange. I want to repeat some of what was
said, so I apologize to the distinguished Presiding Officer, but in the
end I want to try to synthesize what got me to the point of being a
part of S. 30.
In August 2001, when the directive came down, I started learning
about stem cells. When the veto took place last year, I wondered what
more I needed to know to try to find a way to deal with the concerns of
some but the compassion of everyone. I stumbled upon a professor at the
University of Georgia, Dr. Steven Stice. I really didn't stumble upon
him; one of my interns, an honor student, directed me to him. He said
he was doing research in this area.
As it turned out, he was operating three stem cell lines, lines BGO1,
BGO2, and BGO3. So I went to the university and spent 2 days going
through what their research team was doing and the way in which they
were derived. I came to learn that Dr. Stice and his team, like teams
in California, Wisconsin, and other States that have since derived
embryonic stem cells this way, derived them from what is known as
naturally dead or arrested embryos. Those are embryos that after 7 days
following in vitro fertilization stopped cellular division. The embryo
itself is clinically dead, as is a human being who is brain dead,
although all their other organs are working. But contained within that
embryo are stem cells. So it has gone through a natural death, not one
at the hands of a doctor or anyone else, and it produces these stem
cells.
After reading everything I could on it, I want to read one sentence
from just one study which verified the pluripotency, the
undifferentiation, and the independence of those lines:
Lines BGO1, BGO2, and BGO3, human embryonic stem cells are,
therefore, independent, undifferentiated and pluripotent
lines that can be maintained without an accumulation of
karyotypic abnormalities.
It took a long time to practice those last two words and say them
right, but what that practically means is exactly what we all seek.
That is, embryonic stem cells that have the full potential for
research, to answer the hope all of us in this room have expressed
today, can, in fact, be derived from embryos that are not destroyed by
the human hand but through the natural process of the life cycle.
So I asked myself this question: Well, if this is a legitimate
debate--which it is a legitimate debate--if science has found there is
a way to derive these stem cells without the destruction of the embryo,
and if--which is true--5 of the 21 lines currently exempted by the
Presidential order of 2001, are, in fact, 5\1/2\ years of study side by
side with stem cells derived by destroying the embryo, and if we have
clear evidence they are undifferentiated, they are pluripotent, and
they do not have abnormalities, then this is the answer to thread the
needle to solve the problem.
The White House has acknowledged they will sign the bill. So with
respect for every Member of this Senate who has eloquently spoken on
behalf of the hope of furthering research, I do not know what the
results of the research are going to be, but I know this: If we do not
do it, we will never know, and if there is a way to do it and
accelerate it and thread the needle, which this does, then I submit we
should do it.
I would encourage all of my colleagues to support S. 30.
I acknowledge the tremendous work of the Senator from Minnesota and
others who have helped. I appreciate the time allotted to us in this
debate. In the end, I think the most used word in the last 2 days has
been ``hope.'' There is now a hope that we actually bring about the
reality of scientific development for the cure of deadly and terrible
diseases and do so in a way that recognizes the natural process of the
life cycle and the advancement of the science.
With that, I yield back our time in this cycle.
Mr. President, my understanding is--I am going to repeat this--it is
my understanding that we now have a period of 30 minutes that is open,
at which time, following that, each of the four designees will have a
closing 10 minutes.
I see the distinguished Senator from Kansas is on the Senate floor.
My understanding of that 30-minute division, Senator Brownback, is you
would have up to 7\1/2\ minutes of that 30, and if--I would ask--I am
going to try this. I ask unanimous consent that the next 30 minutes be
divided, with 15 minutes under the control of Senator Harkin, 7\1/2\
under the control of Senator Brownback, 7\1/2\ under the control of
myself and Senator Coleman, and then the remaining 40 minutes would be
equally divided between the four designees: Senator Harkin from Iowa,
myself and Senator Coleman, Senator Brownback, and Senator Reid, and
then lastly, the leaders will have 30 minutes equally divided.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. ISAKSON. From what I understood of that agreement, I think the
Senator from Kansas would have 7\1/2\ minutes, then the Senator from
Iowa would have 15, then I would have 7\1/2\. Is that fair?
The PRESIDING OFFICER. The Senator from Kansas is recognized for 7\1/
2\ minutes.
Mr. BROWNBACK. Mr. President, if the Chair would please remind me
when I have a minute left of my time.
The PRESIDING OFFICER. The Chair will do that.
Mr. BROWNBACK. I wish to start by entering into the Record four
documents and briefly covering them as much as possible. I ask
unanimous consent that all four of these documents appear directly
after my testimony.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See Exhibits 1 through 4.)
Mr. BROWNBACK. This first one is the list of 72 current clinical
applications using adult stem cell therapy. No ethical problems on
these. Actually, the list now is 73. I will cover that in just a
minute, but I want to get that in.
I want to back this letter up, or this statement up, with a letter
that appeared in the magazine Science, January 19, 2007, that was
refuting the article--that was a letter put forward by other
individuals questioning this level of adult stem cell therapy and
treatment.
Then this letter which was in the Journal of Science was backed up by
the third document we have here, which is a list of 14 pages of the
peer-reviewed scientific articles on adult stem cell therapies and the
benefits those have produced.
Then the final document we have here in this stack that I will be
putting forward is the article that just appeared out even today from
JAMA, the Journal of American Medical Association, on Type 1 juvenile
diabetes being treated with the use of adult stem cells. The results--I
am just going to
[[Page S4360]]
read these, because they are just so phenomenal, from this JAMA
article: During a 7- to 36-month followup, 14 patients became insulin
free; one for up to 35 months with this treatment.
This was an adult human stem cell treatment. One patient was not able
to become insulin-independent.
The reason I cite that is it is such an exciting set of results.
People have been talking on the floor a great deal about curing
diabetes. Here we have a JAMA article, as I have noted to my colleagues
earlier. The unfortunate thing is the actual test took place in Brazil
instead of the United States even though it was designed and much of it
was done by U.S. scientists at Northwestern University and other
places. The work should be being done in the United States.
Point one being, we don't have to go there with the taxpayer funding
destroying this young human life. I would hope my colleagues would say
that in and of itself is enough information for me to say we do not
need to cross this ethical boundary. The ethical boundary we are
talking about yet again is using taxpayer dollars to fund the
destruction of human life so we can research on these entities. Some
would refer to it as potential for human life; that is human life, so
we can research on it.
Do we want to cross that ethical boundary that has everybody in
somewhat of a question of whether they want to do this or not? I would
submit, No. 1, we do not need to; we have routes to go that work. No.
2, we should not do that in researching on human life because of the
respect we have and the dignity afforded to each and every human life
at all stages, at all places, for the human existence this individuals
has.
Proverbs tell us this: There is a way that seems right to a man, but
its end is the way of death. There is a way that seems right to a man,
but its end is the way of death.
That would seem to really highlight this debate--the way that seems
right to a man. Let's just research on these embryos; they are going to
be disposed of anyway. Why not do it instead of throwing them away? Why
not do it instead of having them being adopted? Why not do it? Why not
research on someone who is on death row? Why not?
There is a way that seems right to a man, but its end is the way of
death. Well, we shouldn't because it does continue that continuation of
us breaching human dignity--at a very early stage, granted, but
nonetheless human by all definition of what a human species and an
individual is. It does breach that, and we should not go there with
taxpayer dollars.
As I have noted to my colleagues, it is legal to do in the United
States. States can fund it, private individuals can fund it. I have
noted to my colleagues that private individuals are not funding it.
They are not funding it because it is speculative, it is not producing
results, and it is producing tumors.
I have entered into the Record previously a large set of different
studies in various areas done by various groups. These embryonic stem
cells are producing tumors. That is what is taking place. There is a
way that seems right to a man, but its end is death. Do we want to put
tumors in individuals? Is that the route we are going forward with? I
don't think so. I don't think we should.
I emphasize as well to my colleagues that we have another route to go
on this that we can work on together. I would hope we could work on the
amniotic fluid and banking of amniotic fluid. I think that would be an
important key route for us to work together.
I am disturbed that at this point in time in the legislative session,
the first half of the year after an election, we are spending this
amount of time on a topic that is going to be vetoed--S. 5 is going to
be vetoed; unlikely that the veto override is going to occur; maybe it
is going to be able to happen but unlikely--when we have other routes
we can work on that will work and will produce results. Are we going to
continue this effort for division? It is all about dividing. It is all
about causing a fight and somebody scoring some political points, when
we have a hopeful route that is producing results that we can work on
together, that we can get more funding for, and everybody wants cures
and we can get more funding for this route which is working, and we can
start a new area in amniotic fluid and placenta or we can go along with
my colleagues from Georgia and Minnesota on a route upon which we can
agree.
The PRESIDING OFFICER. The Senator has 1 minute remaining.
Mr. BROWNBACK. I think we can do those things. Yet we continue down
this route of division. Why would we do that when in the balance sit
patients in this country and around the world who seek our help? I have
shown you many pictures of those who have gotten help but need more and
are having to travel overseas for these treatments. Let's not force
them to do that.
Let's stop the politics of division. Let's start working together and
have a culture that respects human dignity. We can do that. Reject S.
5.
Exhibit 1
72 Current Human Clinical Applications Using Adult Stem Cells
(List Updated March 2007)
anemias & other blood conditions
Sickle cell anemia
Sideroblastic anemia
Aplastic anemia
Red cell aplasia (failure of red blood cell development)
Amegakaryocytic thrombocytopenia
Thalassemia (genetic [inherited] disorders all of which
involve underproduction of hemoglogin)
Primary amyloidosis (A disorder of plasma cells)
Diamond blackfan anemia
Fanconi's anemia
Chronic Epstein-Barr infection (similar to Mono)
AUTO-IMMUNE DISEASES
Systemic lupus (auto-immune condition that can affect skin,
heart, lungs, kidneys, joints, and nervous system)
Sjogren's syndrome (autoimmune disease w/symptoms similar
to arthritis)
Myasthenia (An autoimmune neuromuscular disorder)
Autoimmune cytopenia
Scleromyxedema (skin condition)
Scleroderma (skin disorder)
Crohn's disease (chronic inflammatory disease of the
intestines)
Behcet's disease
Rheumatoid arthritis
Juvenile arthritis
Multiple sclerosis
Polychondritis (chronic disorder of the cartilage)
Systemic vasculitis (inflammation of the blood vessels)
Alopecia universalis
Buerger's disease (limb vessel constriction, inflammation)
BLADDER DISEASE
End-stage bladder disease
CANCERS
Brain tumors--medulloblastoma and glioma
Retinoblastoma (cancer)
Ovarian cancer
Skin cancer: Merkel cell carcinoma
Testicular cancer
Lymphoma
Non-Hodgkin's lymphoma
Hodgkin's lymphoma
Acute lymphoblastic leukemia
Acute myelogenous leukemia
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Juvenile myelomonocytic leukemia
Cancer of the lymph nodes: Angioimmunoblastic
lymphadenopathy Multiple myeloma (cancer affecting white
blood cells of the immune system)
Myelodysplasia (bone marrow disorder)
Breast cancer
Neuroblastoma (childhood cancer of the nervous system)
Renal cell carcinoma (cancer of the kidney)
Soft tissue sarcoma (malignant tumor that begins in the
muscle, fat, fibrous tissue, blood vessels)
Ewing's sarcoma
Various solid tumors
Waldenstrom's macroglobulinemia (type of lymphoma)
Hemophagocytic lymphohistiocytosis
POEMS syndrome (osteosclerotic myeloma)
Myelofibrosis
CARDIOVASCULAR
Acute Heart damage
Chronic coronary artery disease
IMMUNODEFICIENCIES
Severe combined immunodeficiency syndrome
X-linked lymphoproliferative syndrome
X-linked hyper immunoglobulin M syndrome
LIVER DISEASE
Chronic liver failure
Liver cirrhosis
NEURAL DEGENERATIVE DISEASES & INJURIES:
Parkinson's disease
Spinal cord injury
Stroke damage
OCULAR
Corneal regeneration
WOUNDS & INJURIES
Limb gangrene
[[Page S4361]]
Surface wound healing
Jawbone replacement
Skull bone repair
OTHER METABOLIC DISORDERS
Hurler's syndrome (hereditary genetic disorder)
Osteogenesis imperfecta (bone/cartilage disorder)
Krabbe Leukodystrophy (hereditary genetic disorder)
Osteopetrosis (genetic bone disorder)
Cerebral X-linked adrenoleukodystroph
``It is nearly certain that the [human] clinical benefits
of the [embryonic stem cell] research are years or decades
away. This is a message that desperate families and patients
will not want to hear.''--Science, June 17, 2005
Exhibit 2
Treating Diseases With Adult Stem Cells
In their letter ``Adult Stem Cell Treatments for
Diseases?'' (28 July 2006, p.439), S. Smith et al. claim that
we misrepresent a list of adult stem cell treatments
benefiting patients. But it is the Letter's authors who
misrepresent our statements and the published literature,
dismissing as irrelevant the many scientists and patients who
have shown the benefits of adult stem cells.
We have stated that adult stem cell applications have
``helped,'' ``benefited,'' and ``improved'' patient
conditions. Smith et al.'s Supporting Online Material
repeatedly notes patient improvement from these cells. We
have never stated that these treatments are ``generally
available, ``cures,'' or ``fully tested in all required
phases of clinical trials and approved by the U.S. Food and
Drug Administration (FDA).'' Some studies do not require
prior FDA approval, and even the nine supposedly ``fully
approved'' treatments aclmowledged by Smith et al. would not
be considered ``cures'' or ``generally available'' to the
public at this stage of research.
The insistence that no benefit is real until after FDA
approval is misplaced. Such approval is not a medical
standard to evaluate patient benefit, but an agency
determination that benefits outweigh risks in a broad class
of patients. Physicians and patients use an evidentiary
standard. Our list of 72 applications, compiled from peer-
reviewed articles, documents observable and measurable
benefit to patients, a necessary step toward formal FDA
approval and what is expected of new, cutting-edge medical
applications.
Smith et al. also mislead regarding citations for
testicular cancer and non-Hodgkin's lymphoma, referring to
``[t]he reference Prentice cites . . .'' as though only one
reference existed in each case, and not mentioning four other
references that, according to their own SOM, show ``improved
long-term survival'' of patients receiving adult stem cells.
There are currently 1238 FDA-approved clinical trials related
to adult stem cells, including at least 5 trials regarding
testicular cancer and over 24 trials with non-Hodgkin's
lymphoma. They also disregard studies showing successful
stimulation of endogenous cells for Parkinson's.
The ethical and political controversy surrounding embryonic
stem cell research makes scientific claims especially prone
to exaggeration or distortion. All such claims should receive
careful scrutiny, as recently acknowledged by the editors of
this journal after two articles claiming human ``therapeutic
cloning'' success were revealed to be fraudulent. This
scrutiny should be directed equally to all sides. We note
that two of our critics, Neaves and Teitelbaum, are founding
members of a political group whose Web site lists over 70
conditions that ``could someday be treated or cured'' using
embryonic stem cells. High on this list is Alzheimer's
disease, acknowledged by experts as a ``very unlikely''
candidate for stem cell treatments, with one NIH expert
describing such a scenario as a ``fairy tale''. The entire
list, in fact, is based on no evidence of benefit in any
human patient from embryonic stem cells and little evidence
for its claims in animal models. No one should promote the
falsehood that embryonic stem cell cures are imminent, for
this cruelly deceives patients and the public.
CSC Exhibit 3
PEER-REVIEWED REFERENCES SHOWING APPLICATIONS OF ADULT STEM CELLS THAT
PRODUCE THERAPEUTIC BENEFIT FOR HUMAN PATIENTS
Adult Stem Cells--Hematopoietic Replacement
Cancers
Brain Tumors--medulloblastoma and glioma
Dunkel, IJ; ``High-dose chemotherapy with autologous stem
cell rescue for malignant brain tumors''; Cancer Invest. 18,
492-493; 2000.
Abrey, LE et al.; ``High dose chemotherapy with autologous
stem cell rescue in adults with malignant primary brain
tumors''; J. Neurooncol. 44, 147-153; Sept., 1999.
Finlay, JL; ``The role of high-dose chemotherapy and stem
cell rescue in the treatment of malignant brain tumors: a
reappraisal''; Pediatr. Transplant 3 Suppl. 1, 87-95; 1999.
Retinoblastoma
Hertzberg H et al.; ``Recurrent disseminated retinoblastoma
in a 7-year-old girl treated successfully by high-dose
chemotherapy and CD34-selected autologous peripheral blood
stem cell transplantation''; Bone Marrow Transplant 27(6),
653-655; March 2001.
Dunkel IJ et al.; ``Successful treatment of metastatic
retinoblastoma''; Cancer 89, 2117-2121; Nov 15, 2000.
Ovarian Cancer
Stiff PJ et al.; ``High-dose chemotherapy and autologous
stem-cell transplantation for ovarian cancer: An autologous
blood and marrow transplant registry report''; Ann. Intern.
Med. 133, 504-515; Oct. 3, 2000.
Schilder, RJ and Shea, TC; ``Multiple cycles of high-dose
chemotherapy for ovarian cancer''; Semin. Oncol. 25, 349-355;
June 1998.
Merkel Cell Carcinoma
Waldmann V et al.; ``Transient complete remission of
metastasized merkel cell carcinoma by high-dose
polychemotherapy and autologous peripheral blood stem cell
transplantation''; Br. J. Dermatol. 143, 837-839; Oct 2000.
Testicular Cancer
Bhatia S et al.; ``High-dose chemotherapy as initial
salvage chemotherapy in patients with relapsed testicular
cancer''; J. Clin. Oncol. 18, 3346-3351; ct. 19, 2000.
Lymphoma
Tabata M et al.; ``Peripheral blood stem cell
transplantation in patients over 65 years old with malignant
lymphoma--possibility of early completion of chemotherapy and
improvement of performance status''; Intern Med 40, 471-474;
June 2001.
Josting, A; ``Treatment of Primary Progressive Hodgkin's
and Aggressive Non-Hodgkin's Lymphoma: Is There a Chance for
Cure?''; J Clin Oncol 18, 332-339; 2000.
Koizumi M et al.; ``Successful treatment of intravascular
malignant lymphomatosis with high-dose chemotherapy and
autologous peripheral blood stem cell transplantation''; Bone
Marrow Transplant 27, 1101-1103; May 2001.
Non-Hodgkin's Lymphoma
Buadi FK et al., Autologous hematopoietic stem cell
transplantation for older patients with relapsed non-
Hodgkin's lymphoma, Bone Marrow Transplant 37, 1017-1022,
June 2006.
Tabata M et al.; ``Peripheral blood stem cell
transplantation in patients over 65 years old with malignant
lymphoma--possibility of early completion of chemotherapy and
improvement of performance status''; Intern Med 40, 471-474;
June 2001.
Josting, A; ``Treatment of Primary Progressive Hodgkin's
and Aggressive Non-Hodgkin's Lymphoma: Is There a Chance for
Cure?''; J Clin Oncol 18, 332-339; 2000.
Kirita T et al.; ``Primary non-Hodgkin's lymphoma of the
mandible treated with radiotherapy, chemotherapy, and
autologous peripheral blood stem cell transplantation''; Oral
Surg Oral Med Oral Pathol Oral Radiol Endod. 90, 450-455;
Oct. 2000.
Hodgkin's Lymphoma
Peggs KS et al., ``Clinical evidence of a graft-versus-
Hodgkin's-lymphoma effect after reduced-intensity allogeneic
transplantation'', Lancet 365, 1934-1941, 4 June 2005.
Josting, A; ``Treatment of Primary Progressive Hodgkin's
and Aggressive Non-Hodgkin's Lymphoma: Is There a Chance for
Cure?''; J Clin Oncol 18, 332-339; 2000.
Acute Lymphoblastic Leukemia
Laughlin MJ et al.; ``Hematopoietic engraftment and
survival in adult recipients of umbilical-cord blood from
unrelated donors'', New England Journal of Medicine 344,
1815-1822; June 14, 2001.
Ohnuma K et al.; ``Cord blood transplantation from HLA-
mismatched unrelated donors as a treatment for children with
haematological malignancies''; Br J Haematol 112(4), 981-987;
March 2001.
Marco F et al.; ``High Survival Rate in Infant Acute
Leukemia Treated With Early High-Dose Chemotherapy and Stem-
Cell Support''; J Clin Oncol 18, 3256-3261; Sept. 15 2000.
Acute Myelogenous Leukemia
Laughlin MJ et al.; ``Hematopoietic engraftment and
survival in adult recipients of umbilical-cord blood from
unrelated donors'', New England Journal of Medicine 344,
1815-1822; June 14, 2001.
Ohnuma K et al.; ``Cord blood transplantation from HLA-
mismatched unrelated donors as a treatment for children with
haematological malignancies''; Br J Haematol 112(4), 981-987;
March 2001.
Gorin NC et al.; ``Feasibility and recent improvement of
autologous stem cell transplantation for acute myelocytic
leukaemia in patients over 60 years of age: importance of the
source of stem cells''; Br. J. Haematol. 110, 887-893; Sept
2000.
Bruserud O et al.; ``New strategies in the treatment of
acute myelogenous leukemia: mobilization and transplantation
of autologous peripheral blood stem cells in adult
patients''; Stem Cells 18, 343-351; 2000.
Chronic Myelogenous Leukemia
Laughlin MJ et al.; ``Hematopoietic engraftment and
survival in adult recipients of umbilical-cord blood from
unrelated donors'', New England Journal of Medicine 344,
1815-1822; June 14, 2001.
Ohnuma K et al.; ``Cord blood transplantation from HLA-
mismatched unrelated donors as a treatment for children with
haematological malignancies''; Br J Haematol 112(4), 981-987;
March 2001.
Juvenile Myelomonocytic Leukemia
Ohnuma K et al.; ``Cord blood transplantation from HLA-
mismatched unrelated donors as a treatment for children with
haematological malignancies''; Br J Haematol 112(4), 981-987;
March 2001.
Chronic Myelomonocytic Leukemia
Elliott MA et al., Allogeneic stem cell transplantation and
donor lymphocyte infusions for chronic myelomonocytic
leukemia,
[[Page S4362]]
Bone Marrow Transplantation 37, 1003-1008, 2006.
Angioimmunoblastic Lymphadenopathy with Dysproteinemia
Lindahl J et al.; ``High-dose chemotherapy and APSCT as a
potential cure for relapsing hemolysing AILD''; Leuk Res
25(3), 267-270; March 2001.
Multiple Myeloma
Aviles A et al., Biological modifiers as cytoreductive
therapy before stem cell transplant in previously untreated
patients with multiple myeloma, Annals of Oncology 16, 219-
221, 2005.
Vesole, DH et al.; ``High-Dose Melphalan With
Autotransplantation for Refractory Multiple Myeloma: Results
of a Southwest Oncology Group Phase II Trial''; J Clin Oncol
17, 2173-2179; July 1999.
Myelodysplasia
Ohnuma K et al.; ``Cord blood transplantation from HLA-
mismatched unrelated donors as a treatment for children with
haematological malignancies''; Br J Haematol 112(4), 981-987;
March 2001.
Bensinger WI et al.; ``Transplantation of bone marrow as
compared with peripheral-blood cells from HLA-identical
relatives in patients with hematologic cancers''; New England
Journal of Medicine 344, 175-181; Jan 18 2001.
Breast Cancer
Damon LE et al.; ``High-dose chemotherapy and hematopoietic
stem cell rescue for breast cancer: experience in
California''; Biol. Blood Marrow Transplant 6, 496-505; 2000.
Paquette, RL et al., ``Ex vivo expanded unselected
peripheral blood: progenitor cells reduce posttransplantation
neutropenia, thrombocytopenia, and anemia in patients with
breast cancer'', Blood 96, 2385-2390; October, 2000.
Stiff P et al.; ``Autologous transplantation of ex vivo
expanded bone marrow cells grown from small aliquots after
high-dose chemotherapy for breast cancer''; Blood 95, 2169-
2174; March 15, 2000.
Koc, ON et al.; ``Rapid Hematopoietic Recovery After
Coinfusion of Autologous-Blood Stem Cells and Culture-
Expanded Marrow Mesenchymal Stem Cells in Advanced Breast
Cancer Patients Receiving High-Dose Chemotherapy''; J Clin
Oncol 18, 307-316; January 2000.
Neuroblastoma
Kawa, K et al.; ``Long-Term Survivors of Advanced
Neuroblastoma With MYCN Amplification: A Report of 19
Patients Surviving Disease-Free for More Than 66 Months''; J
Clin Oncol 17:3216-3220; October 1999.
Renal Cell Carcinoma
Barkholt L et al., Allogeneic haematopoietic stem cell
transplantation for metastatic renal carcinoma in Europe,
Annals of Oncology published online 28 April 2006.
Arya M et al., Allogeneic hematopoietic stem-cell
transplantation: the next generation of therapy for
metastatic renal cell cancer, Nat Clin Pract Oncol. 1, 32-38,
Nov 2004.
Childs R et al., ``Regression of Metastatic Renal-Cell
Carcinoma after Nonmyeloablative Allogeneic Peripheral-Blood
Stem-Cell Transplantation'', New England Journal of Medicine
343,750-758; Sept. 14, 2000.
Childs, RW; ``Successful Treatment of Metastatic Renal Cell
Carcinoma With a Nonmyeloablative Allogeneic Peripheral-Blood
Progenitor-Cell Transplant: Evidence for a Graft-Versus-Tumor
Effect:; J Clin Oncol 17, 2044-2049; July 1999.
Soft Tissue Sarcoma
Blay JY et al.; ``High-dose chemotherapy with autologous
hematopoietic stem-cell transplantation for advanced soft
tissue sarcoma in adults''; J. Clin. Oncol. 18, 3643-3650;
Nov 1, 2000.
Ewing's Sarcoma
Drabko K et al., Megachemotherapy followed by autologous
stem cell transplantation in children with Ewing's sarcoma,
Pediatric Transplantation 9, 618-621, 2005.
Various Solid Tumors
Pedrazolli P et al., High dose chemotherapy with autologous
hematopoietic stem cell support for solid tumors other than
breast cancer in adults, Annals of Oncology published online
17 March 2006.
Nieboer P et al.; ``Long-term haematological recovery
following high-dose chemotherapy with autologous bone marrow
transplantation or peripheral stem cell transplantation in
patients with solid tumours''; Bone Marrow Transplant 27,
959-966; May 2001.
Lafay-Cousin L et al.; ``High-dose thiotepa and
hematopoietic stem cell transplantation in pediatric
malignant mesenchymal tumors: a phase II study''; Bone Marrow
Transplant 26, 627-632; Sept. 2000.
Michon, J and Schleiermacher, G. ``Autologous
haematopoietic stem cell transplantation for paediatric solid
tumors'', Baillieres Best Practice Research in Clinical
Haematology 12, 247-259, March-June, 1999.
Schilder, RJ et al.; ``Phase I trial of multiple cycles of
high-dose chemotherapy supported by autologous peripheral-
blood stem cells''; J. Clin. Oncol. 17, 2198-2207; July 1999.
Waldenstrom's Macroglobulinemia
Anagnostopou1os A et al.; ``High-dose chemotherapy followed
by stem cell transplantation in patients with resistant
Waldenstrom's macroglobulinemia''; Bone Marrow Transplant 27,
1027-1029; May 2001.
Hemophagocytic Lymphohistiocytosis
Matthes-Martin S et al.; ``Successful stem cell
transplantation following orthotopic liver transplantation
from the same haploidentical family donor in a girl with
hemophagocytic lymphohistiocytosis''; Blood 96, 3997-3999;
Dec 1, 2000.
POEMS Syndrome (Osteosclerotic Myeloma)
Dispenzieri A et al., Peripheral blood stem cell
transplantation in 16 patients with POEMS syndrome, and a
review of the literature, Blood 104, 3400-3407, 15 November
2004.
Myelofibrosis
Cometta K et al., Umbilical cord blood transplantation in
adults: results of the prospective Cord Blood Transplantation
(COBLT), Biol Blood Marrow Transplant 11, 149-160, February
2005.
Cervantes F, Modern management of myelofibrosis, Br J
Haematol 128, 583-592, March 2005.
Kroger N et al., Pilot study of reduced-intensity
conditioning followed by allogeneic stem cell transplantation
from related and unrelated donors in patients with
myelofibrosis, Br J Haematol 128, 690-697, March 2005.
Thiele J et al., Dynamics of bone marrow changes in
patients with chronic idiopathic myelofibrosis following
allogeneic stem cell transplantation, Histol Histopathol 20,
87-89, July 2005.
Rondelli D et al., Allogeneic hematopoietic stem-cell
transplantation with reduced-intensity conditioning in
intermediate- or high-risk patients with myelofibrosis with
myeloid metaplasia, Blood 105, 4115-4119, 15 May 2005.
Benesova Pet al., [Complete regression of bone marrow
fibrosis following allogeneic peripheral blood stem cell
transplantation in a patient with idiopathic myelofibrosis]
[Article in Czech], Cesk Patol 40, 167-171, October 2004.
Adult Stem Cells--Immune System Replacement
AUTOIMMUNE DISEASES
Systemic Lupus
Burt RK et al., Nonmyeloablative hematopoietic stem cell
transplantation for systemic lupus erythematosus, Journal of
the American Medical Association 295, 527-535, February 1,
2006.
Burt RK et al., ``Induction of tolerance in autoimmune
diseases by hematopoietic stem cell transplantation: getting
closer to a cure?'', Blood 99, 768-784, 1 February 2002.
Wulffraat NM et al.; ``Prolonged remission without
treatment after autologous stem cell transplantation for
refractory childhood systemic lupus erythematosus'';
Arthritis Rheum 44(3), 728-731; March 2001.
Rosen O et al.; ``Autologous stem-cell transplantation in
refractory autoimmune diseases after in vivo immunoablation
and ex vivo depletion of mononuclear cells''; Arthritis Res.
2, 327-336; 2000.
Traynor AE et al.; ``Treatment of severe systemic lupus
erythematosus with high-dose chemotherapy and haemopoietic
stem-cell transplantation: a phase I study''; Lancet 356,
701-707; August 26, 2000.
Burt, RK and Traynor, AE; ``Hematopoietic Stem Cell
Transplantation: A New Therapy for Autoimmune Disease''; Stem
Cells 17, 366-372; 1999.
Burt RK et al.; ``Hematopoietic stem cell transplantation
of multiple sclerosis, rheumatoid arthritis, and systemic
lupus erythematosus''; Cancer Treat. Res. 101, 157-184; 1999.
Traynor A and Burt RK; ``Haematopoietic stem cell
transplantation for active systemic lupus erythematosus'';
Rheumatology 38, 767-772; August 1999.
Martini A et al.; ``Marked and sustained improvement 2
years after autologous stem cell transplant in a girl with
system sclerosis''; Rheumatology 38, 773; August 1999.
Sjogren's Syndrome
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Myasthenia
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Autoimmune Cytopenia
Passweg, JR et al., Haematopoetic stem cell transplantation
for refractory autoimmune cytopenia, British Journal of
Haematology 125, 749-755, June 2004.
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Scleromyxedema
A.M. Feasel et al., ``Complete remission of scleromyxedema
following autologous stem cell transplantation,'' Archives of
Dermatology 137, 1071-1072; Aug. 2001.
Scleroderma
Burt RK et al., ``Induction of tolerance in autoimmune
diseases by hemato-
poietic stem cell transplantation: getting closer to a
cure?'', Blood 99, 768-784, 1 February 2002.
Burt, RK and Traynor, AE; ``Hematopoietic Stem Cell
Transplantation: A New Therapy for Autoimmune Disease''; Stem
Cells 17, 366-372; 1999.
Crohn's Disease
Kreisel W et al., Complete remission of Crohn's disease
after high-dose
[[Page S4363]]
cyclophosphamide and autologous stem cell transplantation,
Bone Marrow Transplantation 32, 337-340, 2003.
Burt RK et al., ``High-dose immune suppression and
autologous hematopoietic stem cell transplantation in
refractory Crohn disease'', Blood 101, 2064-2066, March 2003.
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Hawkey CJ et al.; ``Stem cell transplantation for
inflammatory bowel disease: practical and ethical issues'';
Gut 46, 869-872; June 2000.
Behcet's Disease
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Rheumatoid Arthritis
Burt RK et al., ``Induction of tolerance in autoimmune
diseases by hematopoietic stem cell transplantation: getting
closer to a cure?'', Blood 99, 768-784, 1 February 2002.
Burt RK et al., ``Induction of remission of severe and
refractory rheumatoid arthritis by allogeneic mixed
chimerism'', Arthritis & Rheumatism 50, 2466-2470, August
2004.;
Verburg RJ et al.; ``High-dose chemotherapy and autologous
hematopoietic stem cell transplantation in patients with
rheumatoid arthritis: results of an open study to assess
feasibility, safety, and efficacy''; Arthritis Rheum 44(4),
754-760; April 2001.
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Burt, RK and Traynor, AE; ``Hematopoietic Stem Cell
Transplantation: A New Therapy for Autoimmune Disease''; Stem
Cells 17, 366-372; 1999.
Burt RK et al.; ``Hematopoietic stem cell transplantation
of multiple sclerosis, rheumatoid arthritis, and systemic
lupus erythematosus''; Cancer Treat. Res. 101, 157-184; 1999.
Burt, RK et al., ``Autologous hematopoietic stem cell
transplantation in refractory rheumatoid arthritis: sustained
response in two of four patients'', Arthritis & Rheumatology
42, 2281-2285, November, 1999.
Juvenile Arthritis
I M de Kleer et aI., Autologous stem cell transplantation
for refractory juvenile idiopathic arthritis: analysis of
clinical effects, mortality, and transplant related
morbidity, Ann Rheum Dis 63, 1318-1326, 2004.
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Burt, RK and Traynor, AE; ``He-ma-to-poietic Stem Cell
Transplantation: A New Therapy for Autoimmune Disease''; Stem
Cells 17, 366-372; 1999.
Multiple Sclerosis
Saccardi R et al., Autologous HSCT for severe progressive
multiple sclerosis in a multicenter trial: impact on disease
activity and quality of life, Blood 105, 2601-2607, 15 March
2005.
Burt RK et al., ``Induction of tolerance in autoimmune
diseases by hematopoietic stem cell transplantation: getting
closer to a cure?'', Blood 99, 768-784, 1 February 2002.
Mancardi GL et al.; ``Autologous hematopoietic stem cell
transplantation suppresses Gd-enhanced MRI activity in MS'';
Neurology 57, 62-68; July 10, 2001.
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85 (11 Suppl), 81-85;
Nov. 2000.
Burt, RK and Traynor, AE; ``He-ma-to-poietic Stem Cell
Transplantation: A New Therapy for Autoimmune Disease''; Stem
Cells 17, 366-372; 1999.
Burt RK et al.; ``Hematopoietic stem cell transplantation
of multiple sclerosis, rheumatoid arthritis, and systemic
lupus erythematosus''; Cancer Treat. Res. 101, 157-184; 1999.
Polychondritis
Rosen O et al.; ``Autologous stem-cell transplantation in
refractory autoimmune diseases after in vivo immunoablation
and ex vivo depletion of mononuclear cells''; Arthritis res.
2, 327-336; 2000.
Systemic Vasculitis
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85(11 Suppl), 81-85; Nov.
2000.
Alopecia Universal
Seifert B et al., Complete rfemission of alopecia
universalis after allogeneic hematopoietic stem cell
transplantion, Blood 105, 426-427, 1 January 2005.
Buerger's Disease
Kim D-I et al., Angiogenesis facilitated by autologous
whole bone marrow stem cell transplantation for Buerger's
disease, Stem Cells 24, 1194-1200, 2006.
IMMUNODEFICIENCIES
Severe Combined Immunodeficiency Syndrome
Grunebaum E et al., Bone marrow transplantation for severe
combined immune deficiency, Journal of the American Medical
Association 295, 508-518, 1 February 2006.
Cavazzana-Calvo M et al.; ``Gene therapy of human severe
combined immunodeficiency (SCID)-X1 disease''; Science 288,
669-672; April 28, 2000. (NOTE: gene therapy using bone
marrow adult stem cells as gene vehicle.)
X-Linked Lymphoproliferative Syndrome and X-Linked
Hyperimmunoglobulin M Syndrome
Banked unrelated umbilical cord blood was used to
reconstitute the immune system in 2 brothers with X-linked
lymphoproliferative syndrome and 1 boy with X-linked
hyperimmunoglobulin-M syndrome. Two years after
transplantation, all 3 patients have normal immune systems.
These reports support the wider use of banked partially
matched cord blood for transplantation in primary
immunodeficiencies.
Reference:
Ziegner UH et al.; ``Unrelated umbilical cord stem cell
transplantation for X-linked immunodeficiencies''; J Pediatr
138(4), 570-573; April 2001.
Eight children with severe immunodeficiencies treated by
adult bone marrow stem cell transplants. Six of 8 showed
relatively normal immune systems after 1 year.
Reference:
Amrolia, P et al., ``Nonmyeloablative stem cell
transplantation for congenital immunodeficiencies'', Blood
96, 1239-1246, Aug. 15, 2000.
ANEMIAS and OTHER BLOOD CONDITIONS
Sickle Cell Anemia
Klein A et al., Hematopoietic stem cell transplantation for
severe sickle cell disease, Rev Med Brux. 2005;26 Spec
no:Sp23-5.
Adamkiewicz TV et al., Transplantation of unrelated
placental blood cells in children with high-risk sickle cell
disease, Bone Marrow Transplant. 34, 405-411, Sept 2004.
Wu CJ et al., Molecular assessment of erythroid lineage
chimerism following nonmyeloablative allogeneic stem cell
transplantation, Exp Hematol. 31, 924-933, Oct 2003.
Gore L et al.; ``Successful cord blood transplantation for
sickle cell anemia from a sibling who is human leukocyte
antigen-identical: implications for comprehensive care'', J
Pediatr Hematol Oncol 22(5):437-440; Sep-Oct 2000.
Steen RG et al.; ``Improved cerebrovascular patency
following therapy in patients with sickle cell disease:
initial results in 4 patients who received HLA-identical
hematopoietic stem cell allografts''; Ann Neurol 49(2), 222-
229; Feb. 2001.
Wethers DL; ``Sickle cell disease in childhood: Part II.
Diagnosis and treatment of major complications and recent
advances in treatment''; Am. Fam. Physician 62, 1309-1314;
Sept. 15, 2000.
Sideroblastic Anemia
Ayas M et al.; ``Congenital sideroblastic anaemia
successfully treated using allogeneic stem cell
transplantation''; Br J Haematol 113, 938-939; June 2001.
Gonzalez MI et al.; ``Allogeneic peripheral stem cell
transplantation in a case of hereditary sideroblastic
anaemia''; British Journal of Haematology 109, 658-660; 2000.
Aplastic Anemia
Gurman G et al.; ``Allogeneic peripheral blood stem cell
transplantation for severe aplastic anemia''; Ther Apher
5(1),54-57; Feb. 2001.
Kook H et al.; ``Rubella-associated aplastic anemia treated
by syngeneic stem cell transplantations''; Am. J. Hematol.
64, 303-305; August 2000.
Red Cell Aplasia
Rabusin M et al.; ``Immunoablation followed by autologous
hematopoietic stem cell infusion for the treatment of severe
autoimmune disease''; Haematologica 85(11 Suppl), 81-85; Nov.
2000.
Amegakaryocytic Thrombocytopenia
Yesilipek et al.; ``Peripheral stem cell transplantation in
a child with amegakaryocytic thrombocytopenia''; Bone Marrow
Transplant 26, 571-572; Sept. 2000.
Thalassemia
Tan PH et al., ``Unrelated peripheral blood and cord blood
hematopoietic stem cell transplants for thalassemia major'',
Am J Hematol 75, 209-212, April 2004.
Primary Amyloidosis
Sezer O et al.; ``Novel approaches to the treatment of
primary amyloidosis''; Exper Opin. Investig. Drugs 9, 2343-
2350; Oct 2000.
Diamond Blackfan Anemia
Ostronoff M et al., ``Successful nonmyeloablative bone
marrow transplantation in a corticosteroid-resistant infant
with Diamond-Blackfan anemia'', Bone Marrow Transplant. 34,
371-372, August 2004.
Fanconi's Anemia
Bitan M et al., Fludarabine-based reduced intensity
conditioning for stem cell transplantation of fanconi anemia
patients from fully matched related and unrelated donors,
Biol Blood Marrow Transplant. 12, 712-718, July 2006.
Tan PL et at., Successful engraftment without radiation
after fludarabine-based regimen in Fanconi anemia patients
undergoing genotypically identical donor hema-
topoietic cell transplantation, Pediatr Blood Cancer, 46,
630-636, May 1, 2006.
Kohli-Kumar M et al., ``Haemopoietic stem/progenitor cell
transplant in Fanconi anaemia using HLA-matched sibling
umbilical cord blood cells'', British Journal of Haematology
85, 419-422, October 1993.
[[Page S4364]]
Chronic Epstein-Barr Infection
Fujii N et at.; ``Allogeneic peripheral blood stem cell
transplantation for the treatment of chronic active epstein-
barr virus infection''; Bone Marrow Transplant 26, 805-808;
Oct. 2000.
Okamura T et al.; ``Blood stem-cell transplantation for
chronic active Epstein-Barr virus with lymphoproliferation'';
Lancet 356, 223-224; July 2000.
Adult Stem Cells-Repair/Replacement of Solid Tissues
METABOLIC DISORDERS
Hurler's Syndrome
Cox-Brinkman J et al., Haematopoietic cell transplantation
(HCT) in combination with enzyme replacement therapy (ERT) in
patients with Hurler syndrome, Bone Marrow Transplantation
38, 17-21, 2006.
Staba SL et al., Cord-blood transplants from unrelated
donors in patients with Hurler's syndrome'', New England
Journal of Medicine 350, 1960-1969, 6 May 2004.
Koc ON et al., Allogeneic mesenchymal stem cell infusion
for treatment of metachromatic leukodystrophy (MLD) and
Hurler syndrome (MPS-IH), Bone Marrow Transplant 215-222; Aug
2002.
Osteogenesis Imperfecta
Horwitz EM et al., ``Isolated allogeneic bone marrow-
derived mesenchymal cells engraft and stimulate growth in
children with osteogenesis imperfecta: Implications for cell
therapy of bone'', Proceedings of the National Academy of
Sciences USA 99,8932-8937; 25 June 2002.
Horwitz EM et al., ``Clinical responses to bone marrow
transplantation in children with severe osteogenesis
imperfecta'', Blood 97, 1227-1231; 1 March 2001.
Horwitz, EM et al.; ``Transplantability and therapeutic
effects of bone marrow-derived mesenchymal cells in children
with osteogenesis imperfecta''; Nat. Med. 5, 309-313; March
1999.
Krabbe Leukodystrophy
Escolar ML et al., ``Transplantation of umbilical cord-
blood in babies with infantile Krabbe's disease'', New
England Journal of Medicine 352, 2069-2081, 19 May 2005.
Krivit W et al., ``Hematopoietic Stem-Cell Transplantation
in Globoid-Cell Leukodystrophy'', New England Journal of
Medicine 338, 1119-1127, Apr 16, 1998.
Osteopetrosis
Tsuji Y et al., Successful nonmyeloablative cord blood
transplantation for an infant with malignant infantile
osteopetrosis, J Pediatr Hematol Oncol. 27, 495-498, Sept
2005.
Driessen GJ et al., Long-term outcome of haematopoietic
stem cell transplantation in autosomal recessive
osteopetrosis: an EBMT report, Bone Marrow Transplantation
32,657-663, October 2003.
Schulz et al., HLA-haploidentical blood progenitor cell
transplantation in osteopetrosis, Blood 99, 3458-3460, 1 May
2002.
Cerebral X-Linked Adrenoleukodystrophy
Peters C et al., Cerebral X-linked adrenoleukodystrophy:
the international hematopoietic cell transplantation
experience from 1982 to 1999, Blood 104,881-888, 1 August
2004.
OCULAR
Corneal Regeneration
Inatomi T et al., Midterm results on ocular surface
reconstruction using cultivated autologous oral mucosal
epithelial transplantation, American Journal of Ophthalmology
141,267-275, February 2006.
Nishida K et al., Corneal reconstruction with tissue-
engineered cell sheets composed of autologous oral mucosal
epithelium, New England Journal of Medicine 351, 1187-1196,
16 September 2004.
Anderson DF et al.; ``Amniotic Membrane Transplantation
After the Primary Surgical Management of Band Keratopathy'';
Cornea 20(4), 354-361; May 2001.
Anderson DF et al.; ``Amniotic membrane transplantation for
partial limbal stem cell deficiency''; Br J Ophthalmol 85(5),
567-575; May 2001.
Henderson TR et al.; ``The long term outcome of limbal
allografts: the search for surviving cells''; Br J Ophthalmol
85(5), 604-609; May 2001.
Daya SM, Ilari FA; ``Living related conjuctival limbal
allograft for the treatment of stem cell deficiency'';
Ophthalmology 180, 126-133; January 2001.
Schwab IR et al.; ``Successful transplantation of
bioengineered tissue replacements in patients with ocular
surface disease''; Cornea 19, 421-426; July 2000.
Tsai et al.; ``Reconstruction of damaged corneas by
transplantation of autologous limbal epithelial cells''; New
England Journal of Medicine 343, 86-93, 2000.
Tsubota K et al.; ``Treatment of severe ocular-surface
disorders with corneal epithelial stem-cell
transplantation''; New England Journal of Medicine 340, 1697-
1703; June 3, 1999.
WOUNDS & INJURIES
Limb Gangrene
Tateishi-Yuyama E et al.; ``Therapeutic angiogenesis for
patients with limb ischaemia by autologous transplantation of
bone-marrow cells: a pilot study and a randomised controlled
trial''; Lancet 360, 427-435; 10 August 2002.
Surface Wound Healing
Badiavas EV and Falanga V, ``Treatment of chronic wounds
with bone marrow-derived cells'', Archives of Dermatology
139, 510-516, 2003.
Jawbone Replacement
Warnke PH et al., Growth and transplantation of a custom
vascularised bone graft in a man, Lancet 364, 766-770, 28
August 2004.
Skull Bone Repair
Lendeckel S et al., Autologous stem cells (adipose) and
fibrin glue used to treat widespread traumatic calvarial
defects: case report, Journal of Cranio-Maxillofacial Surgery
32, 370-373, 2004.
HEART DAMAGE
Acute Heart Damage
Joseph J et al., Safety and effectiveness of granulocyte-
colony stimulating factor in mobilizing stem cells and
improving cytokine profile in advanced chronic heart failure,
American Journal of Cardiology 97, 681-684, 1 March 2006.
Blocklet D et al., Myocardial homing of nonmobilized
peripheral-blood CD34+ cells after intracoronary injection,
Stem Cells 24, 333-336, February 2006.
Janssens S et al., Autologous bone marrow-derived stem-cell
transfer in patients with ST-segment elevation myocardial
infarction: double-blind, randomised controlled trial, Lancet
367, 113-121, 14 January 2006.
Patel AN et al., Surgical treatment for congestive heart
failure with autologous adult stem cell transplantation: a
prospective randomized study, Journal Thoracic Cardiovascular
Surgery 130, 1631-1638, December 2005.
Ince H et al., Preservation from left ventricular
remodeling by front-integrated revascularization and stem
cell liberation in evolving acute myocardial infarction by
use of granulocyte-colony-stimulating factor (FIRSTLINE-AMI),
Circulation 112, 3097-3106, 15 November 2005.
Ince H et al., Prevention of left ventricular remodeling
with granulocyte colony-stimulating after acute myocardial
infarction, Circulation 112, I-73-I-80, 30 August 2005.
Bartunek J et al., Intracoronary injection of CD 133-
positive enriched bone marrow progenitor cells promotes
cardiac recovery after recent myocardial infarction,
Circulation 112, I-178-I-183, 30 August 2005.
Dohmann HFR et al., Transendocardial autologous bone marrow
mononuclear cell injection in ischemic heart failure,
Circulation 112, 121-126, 26 July 2005.
Wollert KC et al., ``Intracoronary autologous bone-marrow
cell transfer after myocardial infarction: the BOOST
randomised controlled clinical trial'', Lancet 364, 141-148,
10 July 2004.
Britten MB et al., ``Infarct remodeling after intracoronary
progenitor cell treatment in patients with acute myocardial
infarction''; Circulation 108, 2212-2218; Nov 2003.
Perin EC et al.; ``Transendocardial, autologous bone marrow
cell transplantation for severe, chronic ischemic heart
failure''; Circulation 107, r75-r83; published online May
2003.
Stamm C et al.; ``Autologous bone-marrow stem-cell
transplantation for myocardial regeneration''; The Lancet
361, 45-46; 4 January 2003.
Tse H-F et al.; ``Angiogenesis in ischaemic myocardium by
intramyocardial autologous bone marrow mononuclear cell
implantation''; The Lancet 361, 47-49; 4 January 2003.
Strauer BE et al.; ``Repair of infarcted myocardium by
autologous intracoronary mononuclear bone marrow cell
transplantation in humans''; Circulation 106, 1913-1918; 8
October 2002.
Strauer BE et al.; ``Myocardial regeneration after
intracoronary transplantation of human autologous stem cells
following acute myocardial infarction''; Dtsch Med Wochenschr
126, 932-938; Aug 24, 2001.
Menasche P et al. ``Myoblast transplantation for heart
failure.'' Lancet 357, 279-280; Jan 27, 2001.
Menasche P et al. [''Autologous skeletal myoblast
transplantation for cardiac insufficiency. First clinical
case.''] [article in French] Arch Mal Coeur Vaiss 94(3), 180-
182; March 2001.
Chronic Coronary Artery Disease
Strauer BE et al., Regeneration of human infarcted heart
muscle by intracoronary autologous bone marrow cell
transplantation in chronic coronary artery disease, Journal
of the American College of Cardiology 46, 1651-1658, 1
November 2005.
NEURAL DEGENERATIVE DISEASES & INJURIES
Stroke
Shyu W-C et al., Granulocyte colony-stimulating factor for
acute ischemic stroke: a randomized controlled trial,
Canadian Medical Association Journal 174, 927-933, 28 March
2006.
Stilley CS et al., Changes in cognitive function after
neuronal cell transplantation for basal ganglia stroke,
Neurology 63, 1320-1322, October 2004.
Meltzer CC et al.; ``Serial [18F]Fluorodeoxyglucose
Positron Emission Tomography after Human Neuronal
Implantation for Stroke''; Neurosurgery 49, 586-592; 2001.
Kondziolka D et al.; ``Transplantation of cultured human
neuronal cells for patients with stroke''; Neurology 55, 565-
569; August 2000.
Parkinson's Disease
Using Direct Stimulation of Patients' Endogenous Adult Neural
Stem Cells:
Love S et al., Glial cell line-derived neurotrophic factor
induces neuronal sprouting in human brain, Nature Medicine
11, 703-704, July 2005.
Slevin JT et al., Improvement of bilateral motor functions
in patients with Parkinson
[[Page S4365]]
disease through the unilateral intraputaminal infusion of
glial cell line-derived neurotrophic factor, Journal of
Neurosurgery 102, 216-222, February 2005.
Gill SS et al.; ``Direct brain infusion of glial cell line-
derived neurotrophic factor in Parkinson disease''; Nature
Medicine 9, 589-595; May 2003 (published online 31 March
2003).
Spinal Cord Injury
Lima C et al., Olfactory mucosa auto grafts in human spinal
cord injury: A pilot clinical study, Journal of Spinal Cord
Medicine 29, 191-203, July 2006.
LIVER DISEASE
Chronic Liver Disease
Gordon MY et al., Characterisation and clinical application
of human CD34+ stem/progenitor cell populations mobilised
into the blood by G-CSF, Stem Cells 24, 1822-1830, July 2006;
published online March 30, 2006.
Liver Cirrhosis
Terai S et al., Improved liver function in liver cirrhosis
patients after autologous bone marrow cell fusion therapy,
Stem Cells published online 15 June 2006; DOI: 10.1634/
stemcells.2005-0542.
BLADDER DISEASE
End-Stage Bladder Disease
Atala A et al., Tissue-engineered autologous bladders for
patients needing cytoplasty, The Lancet 367, 1241-1246, 15
April 2006.
Exhibit 4
[From the Journal of the American Medical Association, Apr. 11, 2007]
Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in
Newly Diagnosed Type 1 Diabetes Mellitus
Julio C. Voltarelli, MD, PhD; Carlos E.B. Couri, MD, PhD;
Ana B.P.L. Stracieri, MD, PhD; Maria C. Oliveira, MD, MSc;
Daniela A. Moraes, MD; Fabiano Pieroni, MD, PhD; Marina
Coutinho, MD, MSc; Kelen C.R. Malmegrim, PhD; Maria C. Foss-
Freitas, MD, PhD; Belinda P. Simoes, MD, PhD; Milton C. Foss,
MD, PhD; Elizabeth Squiers, MD; and Richard K. Burt, MD.
Context: Type 1 diabetes mellitus (DM) results from a cell-
mediated autoimmune attack against pancreatic beta cells.
Previous animal and clinical studies suggest that moderate
immunosuppression in newly diagnosed type 1 DM can prevent
further loss of insulin production and can reduce insulin
needs.
Objective: To determine the safety and metabolic effects of
high-dose immunosuppression followed by autologous
nonmyeloablative hematopoietic stem cell transplantation
(AHST) in newly diagnosed type 1 DM.
Design, Setting, and Participants: A prospective phase 1/2
study of 15 patients with type 1 DM (aged 14-31 years)
diagnosed within the previous 6 weeks by clinical findings
and hyperglycemia and confirmed with positive antibodies
against glutamic acid decarboxylase. Enrollment was November
2003-July 2006 with observation until February 2007 at the
Bone Marrow Transplantation Unit of the School of Medicine of
Ribeirao Preto, Ribeirao Preto, Brazil. Patients with
previous diabetic ketoacidosis were excluded after the first
patient with diabetic ketoacidosis failed to benefit from
AHST. Hematopoietic stem cells were mobilized with
cyclophosphamide (2.0 g/m \2\) and granulocyte colony-
stimulating factor (10 mg/kg per day) and then collected from
peripheral blood by leukapheresis and cryopreserved. The
cells were injected intravenously after conditioning with
cyclophosphamide (200 mg/kg) and rabbit antithymocyte
globulin (4.5 mg/kg).
Main Outcome Measures: Morbidity and mortality from
transplantation and temporal changes in exogenous insulin
requirements (daily dose and duration of usage). Secondary
end points: serum levels of hemoglobin A1C, C-
peptide levels during the mixed-meal tolerance test, and
anti-glutamic acid decarboxylase antibody titers measured
before and at different times following AHST.
Results: During a 7- to 36-month follow-up (mean 18.8),14
patients became insulin-free (1 for 35 months, 4 for at least
21 months, 7 for at least 6 months; and 2 with late response
were insulin-free for 1 and 5 months, respectively). Among
those, 1 patient resumed insulin use 1 year after AHST. At 6
months after AHST, mean total area under the C-peptide
response curve was significantly greater than the
pretreatment values, and at 12 and 24 months it did not
change. Anti-glutamic acid decarboxylase antibody levels
decreased after 6 months and stabilized at 12 and 24 months.
Serum levels of hemoglobin A1C were maintained at
less than 7% in 13 of 14 patients. The only acute severe
adverse effect was culture-negative bilateral pneumonia in 1
patient and late endocrine dysfunction (hypothyroidism or
hypogonadism) in 2 others. There was no mortality.
Conclusions: High-dose immunosuppression and AHST were
performed with acceptable toxicity in a small number of
patients with newly diagnosed type 1 DM. With AHST, beta cell
function was increased in all but 1 patient and induced
prolonged insulin independence in the majority of the
patients.
Trial Registration: clinicaltrials.gov Identifier:
NCT00315133.
The PRESIDING OFFICER. The Senator from Washington is recognized.
Mrs. MURRAY. Mr. President, I yield myself 10 minutes from this side.
Mr. President, I come to the floor today to speak out in strong
support of the promising research that can save lives and bring hope to
millions of Americans. I will vote for the Stem Cell Enhancement Act of
2007, and I urge all of our colleagues to do so.
More importantly, I urge President Bush to finally hear the voices of
scientists, medical leaders, patients, and more than 500 organizations
that have said loudly and clearly that it is time for promising
research to move forward in this country. It is time to take the
handcuffs off of our scientists, those who say they will then be able
to pursue what all Americans are hoping for and promising research for
so many diseases that impact so many of our families. For too long,
this President has allowed politics and ideology to trump lifesaving
research. We have to correct that mistake. The bill, S. 5, we are
considering today shows us how.
Throughout this country, Americans are suffering from diseases such
as Parkinson's, Alzheimer's, diabetes, multiple sclerosis, and they and
their families are looking to us for help. We have scientists and
researchers who are so eager to provide that help, but today, as we all
know, their hands are tied by the arbitrary restrictions President Bush
imposed back in 2001.
I believe we can allow research on embryonic stem cells, and we can
do so with strong ethical guidelines that are required under this
legislation.
Back in August of 2001, President Bush greatly limited the number of
embryonic stem cells that were available for federally funded research.
Those limits were based on inaccurate science and ideology, and they
have restricted our ability to make progress. At the time, the White
House said there were 78 stem cell lines available for federally funded
research, but now we know there are only 21 such lines. Researchers,
those men and woman whom we count on to find cures to the diseases that
impact so many, believe it is imperative to have access to newer, more
promising stem cell lines that do not pose the risk of contamination.
The first consequence of the President's restriction has been to
limit hope and to limit progress for families who suffer from these
diseases. The second impact has been to push embryonic stem cell
research overseas. That means that our country is falling behind other
countries in a cutting-edge field.
Because of the President's imposed arbitrary limits, we are now in
this country surrendering our scientific leadership to other
countries. That can have far-reaching consequences for our economy and
for our future.
My State of Washington is home to world-class research institutions
such as the University of Washington. I want our country and
institutions such as that to be the leading edge of scientific
frontiers so our country and all of us can benefit from the new
advances.
The bill we are considering today and will vote on this evening will
lift the President's arbitrary restrictions and put in place expanded
research under strict ethical guidelines. It would direct the
Department of Health and Human Services to conduct and support research
on stem cells that are derived from frozen embryos that are now stored
in fertility clinics that would otherwise be destroyed. This bill also
promotes research into finding alternative ways to derive stem cells
that do not involve the destruction of an embryo. This bill imposes
strong ethical guidelines. In fact, the guidelines in this bill are
even stricter than the President's policy.
Embryonic stem cell research is a relatively young field. These cells
were not even isolated in humans until 1998. Scientists believe that
embryonic stem cells are more valuable than adult stem cells because
they can develop into any type of cell or tissue in the body. Think of
all the veterans who are coming home from the war in Iraq who have
spinal cord injuries. Think of all the veterans of the first gulf war
who are now being diagnosed with multiple sclerosis and who could be
helped by this promising research.
In my own family, I have seen up close and personally the impact a
disease such as multiple sclerosis can have. When I was 15 years old,
my dad was diagnosed with multiple sclerosis.
[[Page S4366]]
I saw him in just a few years going from working to being someone who
was home in a wheelchair every single day every single minute. For the
rest of his life, my father was confined to a wheelchair. I can't tell
you what a profound impact that had on my family. My mom had to stay
home and raise myself and my six brothers and sisters. She had to go
back to work and get a job and she had to stay home and take care of
him, all at the same time. It was a very difficult time for my family.
The medical bills were amazing. The challenges my family went through
because of my dad's illness were incredible. I can only imagine what it
might have been like had there been a cure for MS for my family and for
thousands of others. When I was growing up, the promise of this type of
research was not even on the horizon. Today that potential is in our
hands. We need to do everything we can to make sure that that research
is done so families such as mine have hope and opportunity in the
future.
I hope we don't see it continually blocked by an ideological policy
that puts politics over science. It is time to change course and put
our Government on the side of the patients and their families and to
give them hope again.
Last month the Director of the National Institutes of Health told us:
[I]t is clear today that American science would be better
served and the nation would be better served if we let our
scientists have access to more cell lines . . .
The NIH Director said that existing lines will not be sufficient for
the research that needs to be done, and he said that adult stem cells
do not have the same potential as embryonic stem cells. That is the
scientific view of the Director of the National Institutes of Health.
The Senate and the President would be very wise to heed his counsel.
I know what it is like to grow up with someone who has a serious
illness. I can only imagine what it would have been like to know there
was hope and a chance for a cure. I know of many families out there who
have been waiting for this day in the Senate, for us to vote and pass
this important stem cell research bill. I commend Senator Harkin for
his perseverance in coming back and again pushing at this as one of the
first pieces of legislation we consider in this Congress. We all know
it has a ways to go. We know the President has said he might veto it. I
hope he doesn't. I hope he sends a message to some young girl out there
whose dad has just been diagnosed with multiple sclerosis that we are a
country of hope once again.
I urge my colleagues to vote for S. 5. I look forward to its passage
today, moving through conference. I hope it will be signed by the
President.
I yield the floor.
Mr. HARKIN. Mr. President, how much time remains?
The PRESIDING OFFICER. The Senator from Iowa has 7 minutes remaining.
Mr. HARKIN. Mr. President, we are getting close to the end of the
debate, we have some floor time in the next hour or so to go back and
forth. I thought I might take a few moments now to talk about why it is
so necessary to have NIH do this kind of research, to oversee this
research. The Senator from Oklahoma said that a lot of research is
going on now on embryonic stem cells. To be sure, it is. It is going on
in different States, in private institutions, in England and Australia
and France and Japan and Singapore and a few other countries. Why do we
want to get the Federal Government involved? First, there is no other
area of medical research in which we say the Federal Government should
step aside and let the States do it. I know of no other area of medical
research.
I always look at the human genome project. What if we had said to the
States: We are not going to do it. You do it. They might have sequenced
one gene or another or let the private sector do it. They would have
been getting patents on it or everything like. Now we have the mapping
and sequencing of the entire human gene, and you can go online and get
it, free to everybody. Any researcher anywhere can get it. Now they may
take that and develop it into drugs and therapies. That is fine. That
is that sort of symbiotic relationship we have developed very well
between the private pharmaceutical industry and the basic research
industry, which is NIH.
Again, our National Institutes of Health should be involved in
overseeing this, because if we don't have a coherent Federal policy on
stem cells, each State writes its own rules. That means that different
States may have different ethical guidelines. One State would be
different from another. You would wind up with a patchwork quilt of
laws. Then you would wind up with States competing against each other.
So California gets to doing stem cell research, and what it does is, it
hires researchers away from Missouri. Then Missouri is hiring people
away from Iowa and then Ohio. Then New York is trying to bid people
away from Ohio. You get this terrible State-versus-State kind of
competition in stem cell research.
We don't want that. We ought to be doing it on a national basis, a
national effort, and we should not lose the international leadership we
have always had in biomedical research. Should we give it up to
Singapore or to Korea or England? No. We have always been the leader in
the world in biomedical research, and we should continue.
Secondly, the issue of why we have to expand our stem cell policy.
Again, I repeat, for the sake of emphasis, of those 78 cell lines that
were supposedly available on August 9, 2001, only 21 have been
available. A lot of them are sick. They are not propagating properly.
They are unhealthy. Right now NIH is only using between four and six of
these lines and even they, I have been told, are not very healthy. So
the restrictions we have had by the Bush administration, since August
9, 2001, have resulted in a situation where fewer and fewer viable good
stem cell lines are available for NIH researchers. However, during that
same period of time in other sectors, we have derived over 400
different cell lines. Yet no one who gets NIH funding is able to do any
research on these healthy embryonic stem cell lines. That is why we
need to develop these. We need to expand it.
That is what S. 5 does. S. 5 takes off the handcuffs. It lets us use,
under strict ethical guidelines, those embryos that are slated to be
discarded at IVF clinics. With all due respect to my friend from
Georgia, S. 30 does not do that. S. 5, if passed, will do everything
that S. 30 wants to do. If S. 5 passes, what they want to do in S. 30
can be done by NIH. The problem with S. 30 is, if S. 30 passes and S. 5
doesn't, then S. 30 is very limited. It says you can only use these few
embryos that are naturally dead which, by the way, I don't think there
is such a scientific term, but it has been bandied about here and it is
in the bill. There is no such scientific delineation of what is
naturally dead.
So that is the situation we are in. S. 5 will do both. It will open
new stem cell lines with ethical guidelines. It will allow them to
extract stem cells from these nonviable embryos. S. 30 will not. S. 30
still will not permit us to get the healthy stem cell lines our
researchers need. That is why we need to pass S. 5.
Mr. President, how much time do I have remaining?
The PRESIDING OFFICER. The Senator has 2\1/2\ minutes remaining.
Mr. HARKIN. I will conclude my 2\1/2\ minutes then by referring to
the other chart. Again, we have to keep in mind that the policy now in
effect, the policy in effect right now says we could use Federal money
to examine and do research on embryonic stem cells that were derived
prior to 9 p.m., August 9, 2001. But we can't use Federal money to
examine or to do research on stem cells derived after 9 p.m., August 9,
2001. Those are morally unacceptable. Before 9 p.m., August 9, 2001,
that is morally OK. After 9 p.m., it is not morally OK. Who decided
that 9 p.m. on August 9, 2001, was some kind of moral dividing line,
that stem cells derived before that, that is OK, but stem cells derived
after that, that is not OK? Only one person decided that, and that was
President Bush.
The people of this country didn't decide that. Ethicists didn't
decide that. Theologians didn't decide that. Scientists didn't decide
that. President Bush decided that. It is sheer hypocrisy to say we can
fund those before, but we can't fund those after. That is the situation
we find ourselves in today.
Let's take off the handcuffs. Let's get rid of that fake moral
dividing line that has no substance in reality and let's get on with
finding the cures for
[[Page S4367]]
people with Parkinson's and Alzheimer's and spinal cord injuries. That
is what S. 5 is all about.
I yield the floor.
The PRESIDING OFFICER. Who yields time?
The Senator from Minnesota.
Mr. COLEMAN. Mr. President, I thank my colleague, the Senator from
Georgia, for his leadership on this issue, his passion, his knowledge.
He is not a biologist, but I have learned more about God and principle
and stem cell lines from that former real estate guy than the many
doctors I have talked to.
I also thank my colleague from Iowa. I went to law school at the
University of Iowa. I think I have some Iowa roots. The Senator from
Iowa has been a champion of those with disabilities, of disability
rights, a champion of hope for a long time. In this debate there is so
much we agree on. Where we disagree, though, is that S. 30 is not about
a few small lines. S. 30 is about opening up embryonic stem cell
research, research on pluripotent embryonic stem cells, in part, one
technique being dead embryos; another technique being alternate nuclear
transfer, all of which have numerous scientists who say there is hope
for moving the science forward, and we could do it in a way that
doesn't involve the destruction of the human embryo so we don't cross a
moral line but we have all the research we want.
You may ask: How can something so small be so important? To my right
is a chart showing a pinhead. These are the embryonic stem cells right
there. They are the size of a pinhead. That is how big they are. How
could something so small be so important? Size is not the measure of
moral meaning. If you look at it, this point of view from outer space,
and look at the people, that is small, but that crowd has meaning. If
you look at it from a universe perspective to the Earth, boy, that is
really small. You can't even see it. It is not even the size of a
pinhead. Or our galaxy, if I had a picture of the universe, our galaxy
would be the size of a pinhead. What we are talking about today has
meaning. We have an opportunity in this country to come together and
put the politics aside, the ideological divisions aside. The debate
over Federal funding, which has been longstanding Federal policy, we do
not provide Federal funding for the destruction of a human embryo, and
we don't have to. We come together with the same intention. We come
together with the same perspective, with the same hope.
There are two paths to follow. One is S. 5, which will be vetoed and,
in the end, what we will have tomorrow in terms of research is what we
have today, well intentioned, but again, unfortunately, because the
moral line is crossed and the division that will create, it will be
vetoed. There will be no movement forward.
But if we pass S. 30, we have the opportunity to move the science
forward, to create a full range of pluripotent embryonic stem cells. By
the way, if you are just using IVF stem cells, it is a narrow universe.
But with the dead embryo and the altered nuclear transfer, you can
cover every race and ethnic group in America.
The science has gotten way ahead of the politics. We can put ideology
aside. We can put political division aside. We can offer real hope and
real advancement without crossing a moral line. Why wouldn't we do
that? I hope my colleagues see the wisdom in offering hope, in moving
the science forward, and not falling victim to a Presidential veto, but
that, in the end, by next year saying we have more Federal dollars
going into embryonic stem cell research, research on pluripotent stem
cells, stem cells that have the capacity to be perhaps anything. We
don't know, but there is still hope.
There is a lot of research that has to go into it, but we can open
the doors with the passage of S. 30. I urge my colleagues to vote for
S. 30.
With that, I yield the floor and yield back the remainder of our
time.
The PRESIDING OFFICER. The Senator from Georgia.
Mr. ISAKSON. Mr. President, it is my understanding, according to the
unanimous consent agreement, we have four 10-minute periods.
The PRESIDING OFFICER. The Senator is correct.
Mr. ISAKSON. Mr. President, it is further my understanding the first
of those four periods is controlled by me; is that correct?
The PRESIDING OFFICER. Each Senator controls 10 minutes in no
particular order.
Mr. ISAKSON. Mr. President, I will take that time as allocated.
The PRESIDING OFFICER. The Senator from Georgia is recognized for 10
minutes.
Mr. ISAKSON. Mr. President, I thank the Senator from Iowa and the
Senator from Minnesota for their diligent work over the last 2 days on
the floor of the Senate dealing with this issue. I admire the passion
of both. I am so pleased their passion is rooted in their belief, which
I share, that we can move science forward, that we can enhance research
for what are currently incurable diseases, and that we can do so in the
public domain.
Senator Harkin made a very good statement--he has made a number of
good statements, but he made a good statement a little bit ago about
why NIH is important. NIH is important because the research gets in the
public domain, not in the proprietary domain of an investor or someone
who is hoping to find something but does not want to share that with
anybody else. So it is important to find a way to get the NIH
investment in the embryonic stem cell research. S. 5 and S. 30 approach
it from a different direction, but the goal in the end is the same;
that is, to further the science and to find cures.
I grew up in the 1950s and 1960s. In the 1960s, I am reminded of a
statement I heard--often repeated--by then Senator and previously
Attorney General Robert Kennedy. I remember a particular speech he
made, when, having returned from Biafra, where there was a terrible
famine at that time, he said: Some people see things as they are, and
ask, why?--referring to famine. I--meaning him--see things as they
never were and ask, why not?
That is what this is all about. Why not find cures? And why not find
ways to seek those cures that pass the test we desire to pass that S.
30 portends? I have stated on more than one occasion the methodology
and the derivation of these stem cells. It has been questioned a couple
of times, but facts are stubborn. BGO1, BG02, and BG03, currently under
the investment domain of the National Institutes of Health--lines for
which diabetes research, neurological progenitor cell research, and
other research takes place at this very day--were all derived from
embryos that had passed the seventh day following in vitro
fertilization, were naturally dead or arrested but contained
pluripotent embryonic stem cells.
I might add, in vitro fertilization takes place every day in the
United States of America. My family has been touched by it. Many
families have been touched by it. In each of those processes, the
development of those embryos goes through the three stages I have
referred to: Gardner principle I, the first 72 hours; Gardner principle
II, the next 4 days; and then those thereafter where the cells stop
dividing, where the pluripotent stem cells exist but the embryo is not
implanted.
Now, there have been some who have talked about: Well, there is no
evidence of success yet in stem cells. I join Senator Harkin in his
statement that the only way you find out about evidence of success is
by doing the research. But I want to read something I think is
important and I am proud to share because research that has been done
on BGO1 and 03--two of those three lines derived in this methodology--
have had significant research conducted on them in a number of areas.
This has a little bit of technical language, but it expresses the
promise and the hope the Senator from Iowa and I and the Senator from
Minnesota have all talked about. I quote:
The directed differentiation of BGO1 and BG03 cells to
neuroepithelia and multiple differentiated neuronal lineages,
including cells expressing multiple markers of the midbrain
dopaminergic lineage, has previously been demonstrated.
``Previously been demonstrated.'' That statement was confirming the
research on BG01 and 03, designed to see if there was a way to develop
neurological cells that could carry the hope for cures to spinal cord
injury and, in fact, to neurological cell or brain cell injury.
From the research on those three lines, a patent is now pending on a
neurological progenitor cell process, which
[[Page S4368]]
is a real advancement from embryonic stem cell research, from embryonic
stem cells derived from level III Gardner principle derivation or those
derived from an arrested or a dead embryo.
So I would submit my passion for S. 30 is in the hope of finding
cures, in the hope of avoiding a veto, and, instead, having an
investment in the furtherance of science that can grow exponentially
because of the unlimited moral and ethical access that would exist
toward these stem cells.
I conclude by encouraging all the Members of the Senate to
thoughtfully consider S. 30 and encourage them to vote for it as a step
in the right direction, the opening of a door that has, in fact, not
been shut but stuck, and an opportunity to do what everybody in this
Chamber has stated affirmatively they want to do; that is, provide hope
for those who do not have it, expand research in the public domain at
the National Institutes of Health, and invest tax dollars ethically in
a process that brings a promise of hope to every single American.
Mr. President, I yield back my time.
The PRESIDING OFFICER. The Senator from Iowa is recognized.
Mr. HARKIN. Mr. President, again, let me ask, we have, I guess, 20
minutes; is that right?
The PRESIDING OFFICER. The Senator from Iowa controls 10 minutes. The
designee of the majority leader controls 10 minutes.
Mr. HARKIN. Yes. I yield 5 minutes to the Senator from Utah.
Mr. HATCH. I thank my colleague.
The PRESIDING OFFICER. The Senator from Utah is recognized for 5
minutes.
Mr. HATCH. Mr. President, I am going to vote for S. 30. I do not
think it does anything more than the current law is but, nevertheless,
I appreciate the intentions of the two Senators, my dear friends, who
have done this.
Mr. President, as this debate draws to a close, I want to take one
last opportunity to give my strong endorsement to the need for our
country to provide a better level of support for a very promising line
of scientific inquiry: embryonic stem cell research.
While I will vote in favor of both bills, it is S. 5, the Stem Cell
Research Enhancement Act of 2007, that provides the promise of making a
dramatic, yet ethical, difference in the lives of so many. S. 5 offers
people hope who have no hope today. S. 5 has the potential to save
lives. S. 5 opens up a door to medical research that offers much
promise to both the scientific community and the patient community. And
why is that? Because S. 5 allows the Federal Government to fund the
most promising line of stem cell research--embryonic stem cell
research--and S. 30 does not.
Make no mistake about it. Under the current policy, the President's
policy, our Government does support embryonic stem cell research. All
S. 5 would do is expand that policy.
To those who raise questions about the ethicality of this bill, I
answer this way: If it was ethical to implement such a policy in 2001--
and I have heard little criticism about that--then it should be ethical
to adopt S. 5 as well.
Let me underscore the need for this bill with what one of the leading
embryonic stem cell researchers in our country has had to say. I am
speaking about the University of Utah's eminent researcher, Dr. Mario
Cappecchi.
For the benefit of each Senator, the doctor has boiled down the
arguments in favor of the Government funding embryonic stem cell
research. I think it bears repeating, as this is knowledge crucial to
each Member's understanding of what is one of the most critical issues
facing this body today.
Indeed, I believe history will judge us very harshly if we allow this
great opportunity to pass us by. We have to support this research which
to date holds forth more promise than other types of stem cell inquiry.
In the interest of all those who suffer from debilitating diseases and
hope for deliverance, I implore my colleagues to vote for S. 5 and send
a clear message to the American people that we want this research to be
expanded for the good of mankind--of all mankind.
There should be Federal funding for embryonic stem cell research
because: No. 1, it is a potential source of cures; No. 2, embryonic
stem cells grow quickly and are versatile; No. 3, in contrast, adult
stem cells grow slowly; No. 4, adult stem cells are very restricted in
what cell types they can produce; No. 5, the tissue in many important
organs does not have adult stem cells so therapies for diseases
involving those tissues would not be readily approachable by adult stem
cell-based therapy; No. 6, the usefulness of existing embryonic stem
cell lines is extremely limited; No. 7, somatic cell nuclear transfer
is an important research tool; No. 8, SCNT allows production of
patient-specific stem cells to treat complex human diseases like
Alzheimer's and Parkinson's; No. 9, lack of Government commitment means
lack of future researchers; and No. 10, the health and economic
implications of human stem cell research are enormous. Other countries
have realized this; we are in grave danger of falling behind.
I read Dr. Cappecchi's points again for one reason--I want all of my
colleagues to recognize that much is weighing in the balance on today's
vote.
Therefore, I ask my colleagues to consider carefully the positions
they take today.
In the interests of all those who suffer from debilitating diseases
and hope for deliverance, I urge my colleagues to vote for S. 5.
Let me close by making a point I made to President Bush back in 2001:
In the opening days of your term in office, scientists have
completed the task of sequencing the human genome. While this
accomplishment--the work of many in the public and private
sectors--is of historical significance, it is only the end of
the beginning in a new era of our understanding of the
biological sciences. Over your next eight years in office,
you have an unprecedented opportunity to provide the personal
leadership required to see to it that your Administration
will be remembered by future historians as the beginning of
the end for such deadly and debilitating diseases as cancer,
Alzheimer's and diabetes.
That is what S. 5 is all about--providing a potential new avenue of
research that may lead to treatments and cures for many diseases that
afflict many families across our Nation and the world.
While I have no objections to S. 30, let us not delude ourselves into
thinking it is the best solution. S. 5 is the bill that will clearly
make a significant difference in the future of medical research for all
of the reasons I have outlined today.
For those who oppose any type of embryonic stem cell research, let me
say this: For the life of me, I cannot understand how we can destroy
7,000 to 20,000 live in vitro fertilized eggs every year--just destroy
them, kill them--without using those for the benefit of--let's just
choose one malady--kids with diabetes, virulent diabetes, who might
lose their eyes, their hands, their feet. Why wouldn't we do everything
in our power to utilize those rather than cast them aside as hospital
waste? I cannot understand that. That is not pro-life; that is
prodeath. Frankly, being pro-life is not just caring for the unborn, it
is caring for the living as well.
While I will be voting for both S. 5 and S. 30, I believe that S. 5
is clearly preferable to S. 30. S. 5 permits Federal funding for
embryonic stem cell research, S. 30 does not. S. 5 is the bill that
will clearly make a significant difference in the future of medical
research for all of the reasons I have outlined today.
I urge all of my colleagues to vote in favor of S. 5.
The PRESIDING OFFICER. The Senator has used 5 minutes.
Mr. HATCH. I thank my dear colleague for allowing me to make those
remarks on the floor. This is an important debate. I hope we can get
the 67 votes that are essential because we are going to get them
someday. It is just, why put it off another 2 years?
I thank my colleague.
The PRESIDING OFFICER. The Senator from Iowa is recognized.
Mr. HARKIN. Mr. President, I thank my colleague, my friend from Utah,
for a very strong, very powerful, poignant statement. There has been no
stronger leader in this Senate on health, life issues than Senator
Hatch. I thank him for his support of S. 5.
Mr. President, I yield 5 minutes to Senator Smith of Oregon.
The PRESIDING OFFICER. The Senator from Oregon is recognized.
Mr. SMITH. Mr. President, I thank Senator Hatch and Senator Harkin
for their leadership on this vital issue.
The Senate today has conducted a very dignified debate on an issue
that
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brings us right to the edge of science and faith. I have argued for
several years now that science and faith need not be in conflict on
this issue. I have always supported in vitro fertilization, believing
that is a noble way to help infertile couples to be parents.
Today in America there are probably a million children who are now
Americans because of this process. The inevitable consequence, however,
of in vitro fertilization is that excess embryos are created. The
question we are debating is, frankly, whether they constitute human
life, when does life begin.
My colleague, Senator Hatch, has argued nobly and long for the
proposition that life begins not with a scientist, it begins with a
mother. It begins when cells and spirit are joined to create a living
soul. If you have an embryo in a petri dish and you leave it there for
1,000 years, at the end of that time, you will have an embryo in a
petri dish for the simple, logical reason that life begins with mom.
Life begins with the joining of flesh and the spirit. Then the question
becomes: Is it more moral to throw all these embryos away or is it more
moral to allow them to be utilized for medical miracles? I have reached
the conclusion that we cannot have tomorrow's miracles if we tie
scientists' hands with yesterday's rules.
I believe we can, consistent with religion, faith, science, and
logic, allow embryonic stem cell research to proceed. We should do this
because it is morally right. We should do this because the U.S.
Government needs to show up to work on this vital issue. We should do
this because the resources we can provide and the ethical boundaries we
can create are essential for this new area of science to go forward,
giving us a chance to cure some of the most horrible maladies that
afflict humankind, whether it is Lou Gehrig's, whether it is
Parkinson's, childhood diabetes, cancer, and more. We can't
overpromise, but the people afflicted with this that I see all the time
in the State of Oregon need our best effort, and they need us to keep
hope alive.
So I urge my colleagues to vote for both the bills before us today
because it is a morally right thing to do. It is a pro-life thing to
do. It is important that an ethic of life care for the unborn as well
as for those who are living, both the sanctity of life and the quality
of life.
I believe life begins with mom, not in a science lab. Because of
that, I am voting for this, and I do so with respect for the feelings
of my colleagues who have a different theological conclusion. I believe
that scripture and science are not in conflict on this issue and that
life begins with mother.
With that I yield the floor, and I urge and affirm the vote on both
these important pieces of legislation.
The PRESIDING OFFICER (Mr. OBAMA). Who yields time?
Mr. HARKIN. Mr. President, how much time remains?
The PRESIDING OFFICER. The Senator has 10 minutes of time as designee
of the majority leader.
Mr. HARKIN. I thought I had 12 minutes left, until 5:15. Well,
anyway, in closing, first let me thank my colleagues, Senator Isakson,
Senator Coleman, Senator Brownback, and others who have participated in
this debate. It has been a very informed and a very good debate over
the last 2 days. I thank my colleague, Senator Isakson, for his many
courtesies. There were a lot of things we agree on and obviously there
are things we disagree on, but that is the march of legislation in the
Senate. I wish to thank Senator Isakson and others for their speeches
and for their insight into this very important issue. I particularly
wish to thank Senator Hatch and Senator Smith for their great
leadership on this and so many other health issues in the Senate and
for their very poignant, very powerful statements they made on the
Senate floor.
I started this whole debate yesterday morning by talking about hope,
hope for cures for Parkinson's, to repair spinal cord injuries, to end
the scourge of juvenile diabetes, to lift the death sentence of those
afflicted with Lou Gehrig's disease, or ALS, hope for families with
someone lost to Alzheimer's disease. S. 5, the bill before us that will
be our first vote, is a bill that provides this hope, not a hope based
on dreams or fiction but based on solid scientific foundation. It is
why 525 disease-related groups and research institutions and
universities all support S. 5, because it has solid scientific
foundation. It is why the Director of NIH, Dr. Zerhouni, recently said
more embryonic stem cell lines needed to be investigated:
It is clear today that American science would be better
served and the Nation would be better served if we let our
scientists have access to more cell lines.
That is what S. 5 does: provides more cell lines.
It is why the former Director of NIH, Dr. Varmus, a Nobel laureate,
supports S. 5, to take the handcuffs off our scientists. I wish to make
it again abundantly clear, as there has been a lot of misinformation in
the last couple of days on the floor, that S. 5 somehow contains money
for the destruction of embryos. That is not true. I challenge anyone to
show me in the bill anywhere where it contains any money for the
destruction of embryos. It is simply not true. Anyone who says
otherwise is simply not being accurate.
There are those who say: Well, the Federal Government shouldn't get
involved. We can leave it up to the States and private entities. Well,
we can't do that. We need coherence. We need to have the crown jewel of
the Federal Government, the National Institutes of Health, to oversee
this so we have good, strong ethical guidelines, so we have
compatibility, so we have the kind of interplay between scientists that
is necessary to advance scientific research. To leave it up to the
States means we will have a patchwork quilt of laws all over this
country when it should be a national effort--a national effort. Then we
will have States bidding against one another for scientists to come to
their States to do this research. We don't want that to happen.
Lastly, we cannot afford to lose our global leadership in biomedical
research. We, the United States of America, have always been the
world's leader in biomedical research. All the great scientific
discoveries, whether it is the polio vaccine, smallpox, all these
things that have made our lives better; all the new drugs we have for
fighting AIDS around the world came from the United States. All the
cancer interventions, the reason cancer is now on the decline is
because of biomedical research in this country. We can't afford to lose
that to other countries. We need to keep it in America.
So what it comes down to in the final analysis is simply this: If you
want to promote good science, vote for S. 5. If you want strong ethical
standards, S. 5 has the strongest ethical guidelines, stronger than
what the Bush administration has right now and stronger than any other
bill that has come before the floor of the Senate. If you want to move
ahead with more cell lines, as Dr. Zerhouni wants, S. 5 is the bill
that will provide those cell lines. If you want to put embryonic stem
cell research into overdrive, to make it a national priority to do this
research, S. 5 will put it into overdrive. If you want to say to Karli
Borcherding right here, age 12, using 120 needles a month to give
herself insulin shots because she has juvenile diabetes; if you want to
say to Karli Borcherding and all the other kids with juvenile diabetes,
if you want to say to them that we are going to give you hope, we are
going to give you hope that your diabetes will be cured, hope that you
can live a full and normal life; if you want to say to those families
who have a loved one suffering from Alzheimer's, we are going to give
you hope; if you want to say to those who have a family member
suffering from Parkinson's disease or under the death sentence of ALS,
we are going to give you hope--hope not based upon fiction, not based
upon some will-of-the-wisp thoughts that somebody might have but hope
based on solid science that scientists know we can use.
We have already taken embryonic stem cells and made nerve cells,
motor neurons, bone cells, heart muscle cells. We know that it can be
done. Yet our scientists are handcuffed today because of the policy
laid down by President Bush on August 9 of 2001. It is time to lift
those restrictions.
Some say the President will veto this bill. We can't decide what we
do around here because a President--any President--threatens to veto
something. We have to do what is right. We have to do what the people
of America want us to do. We have to do what is in the best
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interests of this country as we see our duty to do it. I hope the
President will sign this bill. I hope he will see we have made our
compromises, that we have strong ethical guidelines, that this is the
way to give hope to Karli Borcherding.
So I hope we don't fall prey to: Well, we can't pass this because the
President will veto it. We have to do what we think is right. The right
thing to do is to support S. 5. As Senator Hatch so eloquently said,
let those thousands of embryos that are being discarded every year in
in vitro fertilization clinics, let them be used to provide life to
other people, hope to Karli Borcherding, hope for people suffering from
multiple sclerosis, spinal cord injuries. To me, that is the true
ethical course to take. That is the guideline I think we must follow.
Let those embryos be used to provide hope to these people.
Mr. President, I see my colleague and a cosponsor of our bill who has
been a leader on this issue for so many years, and I yield the
remainder of our time to Senator Specter of Pennsylvania.
The PRESIDING OFFICER. The Senator from Pennsylvania is recognized.
Mr. SPECTER. Mr. President, on so many merits, the support has been
overwhelming to allow Federal funds to be used for embryonic stem cell
research. There are 400,000 of these embryos which will be discarded.
If they can produce life, no one would want to have research done. The
fact is we appropriated $2 million and only about 135,000 of those
400,000 embryos have been used. So it is a matter of use them or lose
them, pure and simple.
The only reason not to advance this research is on the life issue,
and that is gone. We have had some of the staunchest pro-life
supporters in this Chamber endorsing this bill and this concept. The
potential for medical research to cure or ameliorate the worst maladies
of our era will be present with the use of embryonic stem cell
research. What is involved here is when the people of the United States
will demonstrate sufficient political will to insist that the Congress
and the White House adopt legislation to use Federal funding for
embryonic stem cell research. That is the only question.
We started this on December 2, 1998, with the first hearing, and we
have made a fair amount of progress. It is my hope the President will
sign the bill and not veto it, but he has already said he will veto the
bill. So with 110 million Americans directly, personally, or
indirectly, through families with a stake on their health and on their
family's health, it is a question of when America will move to insist
the Congress act and, if necessary, override a Presidential veto. It is
not a question of if it will be done, it is a question of when. I hope
this discussion and the proceedings now will motivate the American
people to say to Washington: Get it done.
The PRESIDING OFFICER. The Senator's time has expired.
The Senator from Kansas, under the previous agreement, is now
controlling time and has 10 minutes.
Mr. BROWNBACK. Mr. President, I want to give two numbers to my
colleagues: 613 and zero--$613 million spent on embryonic stem cell
research since 2002 and the number of human treatments we have to show
for it, which is zero, 613 to zero. I think those are two important
numbers to remember when what we are after is cures, and we have cures
to show. We have cures that are working, and we can take the next $613
million and invest it in places that are getting cures, such as adult
stem cells, cord blood, and amniotic fluid.
Do we want to spend another $613 million and use Federal taxpayer
dollars to destroy young human life in the process--an ethical boundary
we have not thought wise to cross before? Do we want to cross that
boundary and spend more money and still not get results, when we have a
proven route we can take?
I urge my colleagues to reject and vote against S. 5 on two grounds.
No. 1, ethical grounds. Embryonic stem cell research, even if presented
in supposedly ethical terms, remains unethical, with the destruction of
human life. No. 2, practical grounds. We don't have an infinite budget,
and in the stem cell field, we need to put our money into areas where
we are getting real results--the adult field--and not divert them to
the speculative embryonic stem cell field. Let the private sector or
the States do it. If they want to go into these areas, they can do so.
Let me discuss ethics. Will we sanction the destruction of nascent
human life with Federal taxpayer dollars? That is the central question
surrounding S. 5. Those voting for it would say yes. I say no. I
respect my colleagues who look at this differently, but those are the
facts.
No. 2, individuals should be treated with respect, whoever they are,
wherever they are located, at whatever age or stage of life they are
in. We should avoid prejudices. Each individual has an inalienable
right to life.
Claims that embryos are merely ``potential life'' are not supported
by the science. From biology textbooks, we learn:
Although life is a continuous process, fertilization is a
critical landmark because, under ordinary circumstances, a
new, genetically distinct human organism is thereby formed. .
. .
It takes place in the beginning. The embryo is not ``potential
life,'' it is human life at that particular stage of development in the
life cycle continuum. That is not Sam Brownback; that is biology. The
embryo would continue along the life cycle continuum if we were not
interfering in its normal development by keeping it in a freezer or
destroying it for experiments.
With the scientific fact in hand, we evaluate the facts in light of
our ethical framework. For instance, we know the human embryo is a
human life, so how should we treat it?
Human life has immeasurable value--we can all agree on that--from the
youngest to the oldest. Human beings are ends in themselves. It is
wrong to use any human as a means to an end, period. That has happened
in human history before. It has always been regretted. Our value is
intrinsic. Yes, we want to help and treat people with medical
conditions, but we must not trample upon any human to achieve such a
good end.
Treatments. There remain no embryonic human treatments or
applications despite 25 years of embryonic work in animal models and a
decade of work with human embryonic stem cells, and $613 million has
been invested since 2002 at the Federal level. That doesn't include
States, private, and other governments.
What we have learned about embryonic stem cells is that these cells
form tumors when implanted. The scientific literature abounds with such
stories. If you read this article from ``Stem Cells,'' you will find
this:
The expression of the insulin gene could be demonstrated
only when the cells differentiated in vivo into teratomas.
Those are tumors.
Moving from the ethical to the practical, should we put millions or
billions of dollars into speculative research on these tumor-forming
embryonic stem cells or should we put our money where we are already
getting strong results with adult stem cells?
I have this. It is the front page of the research journals on adult
and cord blood stem cell research and the successes since 2002. Are
there similar files for embryonic stem cells? No, there are none. Adult
stem cells have no ethical strings attached. You can get them from an
adult without causing the patient harm; you can harvest them from rich
cord blood, and, as noted in the Journal of the American Medical
Association on March 7 of this year, they can be obtained from amniotic
fluid without causing harm to the unborn child.
When we started this debate yesterday, we were aware of at least 72
peer-reviewed, real human treatments and applications using adult stem
cells. Now, with the breaking news yesterday on juvenile diabetes from
Northwestern University in Chicago, worked on in Brazil, we are at 73.
Again, there remain no embryonic stem cell applications.
I say to my colleagues, remember Jacki Rabon, a lady from Illinois, a
constituent of the Senators from Illinois, who has spinal cord
injuries. She had to go to Portugal to be treated. Do not divert funds
away from successful adult stem cell treatments and force your
constituents to go to Portugal at great personal expense. Vote against
S. 5 and put the money into adult stem cell research.
Remember David Foege. For your constituents who have heart disease,
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do not divert funds away from successful adult stem cell treatments. Do
not force your constituents to go to Bangkok at great personal expense.
Vote against S. 5.
Remember Dennis Turner. For your constituents with Parkinson's, don't
divert funds away from successful adult stem cell treatments. Let us
provide these treatments here in America. Vote against S. 5.
Remember the 13 diabetes patients whom we learned about yesterday who
have gone 3 years insulin-free using a treatment with their own adult
stem cells. Don't divert these funds away from this area. Vote against
S. 5.
Mr. President, the Proverbs tell us that there is a way that seems
right to man, but its end is the way of death. That seems right to some
people. I respect their opinion and I respect them, but its end is the
way of death. Killing young human life harms us as a culture, when we
treat human life as property. We have done that, and we don't like the
history associated with it.
These embryonic stem cells form tumors. Tumors remind me of death. Do
we want to go that way, even though it may seem right? These embryos
are going to be destroyed, so why not? Somebody on death row is going
to be destroyed, so why not? Because they have dignity, and they remain
dignified. We should treat them with dignity, as we should here. Vote
against S. 5.
I yield the floor.
____________________