[Congressional Record Volume 152, Number 93 (Monday, July 17, 2006)]
[Senate]
[Pages S7569-S7623]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FETUS FARMING PROHIBITION ACT OF 2006
______
ALTERNATIVE PLURIPOTENT STEM CELL THERAPIES ENHANCEMENT ACT
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STEM CELL RESEARCH ENHANCEMENT ACT OF 2005
The ACTING PRESIDENT pro tempore. Under the previous order, the hour
of 12:30 having arrived, the Senate will proceed to the consideration
of S. 3504, S. 2754, and H.R. 810, en bloc, which the clerk will
report.
The legislative clerk read as follows:
A bill (H.R. 810) to amend the Public Health Service Act to
provide for human embryonic stem cell research.
A bill (S. 3504) to amend the Public Health Service Act to
prohibit the solicitation or acceptance of tissue from
fetuses gestated for research purposes, and for other
purposes.
A bill (S. 2754) to derive human pluripotent stem cell
lines using techniques that do not knowingly harm embryos.
Mr. SPECTER. Mr. President, I ask unanimous consent that I may use
this hourglass during the course of the debate.
The ACTING PRESIDENT pro tempore. Without objection, it is so
ordered.
Mr. SPECTER. Mr. President, it is difficult to characterize the
importance of the debate which the Senate is now beginning because the
most fundamental aspect of human life is our health. Without our
health, there is nothing we can do. Medical research has performed
wonders, and stem cells, which came upon the scene in November of 1998,
have the most remarkable potential of any scientific discovery ever
made with respect to human health. These stem cells have the capacity
to regenerate disease cells in the human body and have the capacity to
cure maladies of all sorts, including cancer, heart disease,
Parkinson's, Alzheimer's, spinal cord--the long litany of maladies
which confront mankind.
The stem cell debate began with the hearings conducted by the
Appropriations Subcommittee on Labor, Health and Human Services, which
I chair and on which Senator Tom Harkin is ranking member. We began
those hearings within days of the November 1998 announcement and have
had some 18 hearings on stem cells to explore all ramifications of the
potential of stem cells.
There is now an avalanche of evidence that the use of stem cells in
scientific research has boundless potential. The state of the law is
that federal funding may only be used for a limited number of obsolete
stem cell lines.
The bill which is the fundamental issue before the Senate today is
H.R. 810, which Senator Harkin and I introduced as a Senate bill with
some 42 cosponsors, which would allow research on embryonic stem cells.
There are two other bills at issue. One is S. 2754 which Senator
Santorum and I have introduced which relates to long-range research not
involving the embryos, but it is totally separate and distinct from
H.R. 810 in that it does not have the potential that the embryonic stem
cells have and it is long range.
The third bill is S. 3504 which relates to fetus farming prohibition,
and I believe there will be little controversy about this bill. The
bill would deal with two unethical activities--the solicitation or
acceptance of human fetal tissue knowing that a pregnancy was
deliberately initiated to provide such tissue and the solicitation or
acceptance of tissues or cells from a human embryo or fetus that was
gestated in the uterus of a nonhuman animal. I believe there will be no
contest about that.
I expect relatively little contest about S. 2754, which does not in
any way relate to the importance of research on embryonic stem cells.
The embryonic stem cells are used from many embryos which have been
created for in vitro fertilization. Customarily, a dozen or so are
created, maybe three or four are used, and the others are then frozen
and ultimately will be discarded. There are some 400,000 of those
embryos which are frozen today, and the likelihood of their being used
is nil.
Senator Harkin and I introduced legislation to provide for Federal
funding to encourage adoption of these embryos. If they could be used
to create human life, I would not in the remotest way contend that they
ought to be used for scientific research. But the fact is that they
will either be used for scientific research or thrown away.
When the issue of adoption was raised, as I say, we took the lead in
the Labor, Health and Human Services, and Education Subcommittee in the
year 2002 and appropriated $1 million and since then have appropriated
more in succeeding years.
As of May 31, 2006, the Snow Flake Organization, one of the
Department of Health and Human Services' embryonic adoption grantees,
had a news conference announcing that there had been 100 births since
1997. As of May 31, 2006, the National Embryo Donation Center had a
total of 28 deliveries or ongoing pregnancies. Out of the 400,000, even
with Federal funding available to encourage adoption, the number is
128, which makes it conclusive that these 400,000 embryos will either
be used for scientific research or thrown away.
The bill which Senator Harkin and I have introduced is very carefully
structured to be sure that it satisfies the strictest ethical scrutiny.
This is the essence of the bill: first, that the stem cells were
originally created for fertility treatment purposes; second, are in
excess of the clinical need; third, the individual seeking fertility
treatments for whom the embryos were created has determined that the
embryos will not be implanted in a woman; fourth, they will be
otherwise discarded; and fifth, the individual for whom embryos were
created has provided written consent for embryo adoption.
This bill does not allow Federal funds to be used for the derogation
of stem cell lines, a step in the process where the embryo is
destroyed--the lines are created and the embryos are destroyed before
they are subjected to research which is funded by the Federal
Government under the bill which Senator Harkin and I are promoting.
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The evidence of the utility of these embryonic stem cells is
unquestioned, and the need for more stem cell lines similarly is
unquestioned.
On August 9, 2001, President Bush made an Executive determination to
allow Federal research on some 60 existing stem cell lines. It was
later determined that there might be as many as 70 lines. It has since
been determined that there are no more than 20 lines, and perhaps even
fewer. These existing lines are tainted with mouse feeder cells, which
is a technical consideration that they can't be used.
The experts in the field: Dr. Nabel, Director of the National
Institutes of Health (NIH) Heart, Lung, and Blood Institute, focused on
the unavailability of stem cells for research, noting that only four
stem cell lines are currently in common use.
The enormous advantages of stem cells were outlined in some detail by
the various Directors of the NIH.
Dr. Zerhouni, Director, NIH, said:
Embryonic stem cell research holds great promise for
treating, curing, and improving our understanding of disease,
as well as revealing important basic mechanisms involved in
cell differentiation and development.
Dr. Fauci, Director of the National Institute of Allergy and
Infectious Diseases, said:
NIAID believes that embryonic stem cell research could be
advanced by the availability of additional cell lines.
Individual stem cell lines have unique properties. Thus, we
may be limiting our ability to achieve the full range of
potential therapeutic applications of embryonic stem cells by
restricting research to the relatively small number of lines
currently available.
Dr. Battey, Director of the Deafness Institute, said:
The more stem cell lines available for study the more
likely a cell line will be maximally useful for a given
research, and potentially clinical, application . . . the
scientific community would be best served by having a greater
number of human embryonic stem cell lines available for
study.
Dr. Nabel, the director of the Heart, Lung, and Blood Institute,
said:
. . . we recognize that the limitations of existing cell
lines are hindering scientific progress among a community
that is very eager to move forward in this promising area. We
support the creation of dissemination of newer stem cell
lines in the expectation that it will advance this field and
hasten progress in basic and clinical research.
Similar opinions were articulated by Dr. Tabak, director of the
Dental Institute; by Dr. Volkow, director of the National Institute of
Drug Abuse; by Dr. Collins of the Human Genome Institute; by Dr.
Neiderhuber, director of the Cancer Institute; by Dr. Rodgers, acting
director of the Diabetes and Digestive Disease Institute; by Dr.
Landis, director of the Neurology Institute; by Dr. Berg, director of
the General Medical Sciences Institute; by Dr. Alexander, director of
the Child Health Institute; by Dr. Sieving, director of the Eye
Institute; by Dr. Schwartz, director of the Environmental Health
Institute; by Dr. Hodes, director of the Aging Institute; by Dr. Li,
director of the Alcohol Abuse Institute; by Dr. Alving, acting director
of the Center for Research Resources. All concur with the need for
additional stem cell lines for research in dealing with the maladies in
their own particular area.
By way of a strictly personal note, I had a little root canal work
done this morning. The dentist asked me what was going on in the Senate
today. I told him about stem cell research. He said: I hope you win
your case because it will help us on root canal work. The embryonic
stem cells can be injected into the canal with the diseased tissue, and
you can have a third set of teeth.
Wherever I turn, people in the medical research field--and I regret I
have had a lot contacts--extol the enormous virtues of stem cells--that
they have the capacity to replace diseased cells. If you deal with a
heart problem and you have a diseased area, the stem cells can be
injected. These embryonic stem cells have remarkable flexibility and
capacity to provide a healthy cell to replace the diseased cell.
We have had remarkable articulation of support from Members of the
Senate, as well as Members of the U.S. House of Representatives. The
House bill was passed with a comfortable margin, with some 50
Republicans crossing party lines. In the Senate, we have many Senators
who are most actively known in the pro-life community, and while they
would not make a woman's right to choose available, they do actively
support stem cell research. It is important to focus on the difference
that being against a woman's right to choose has nothing to do with the
issue of stem cell research. They are entirely separate.
Authors of the June 4, 2004, letter to the President on stem cell
research include some of the strongest pro-life Senators in our body,
including Senator Orrin Hatch, Senator Gordon Smith, Senator Lamar
Alexander, Senator Thad Cochran, Senator Kay Bailey Hutchison, Senator
Trent Lott, Senator John McCain, and Senator John Warner. There is
every expectation there will be more Senators from the strong pro-life
community who will be supporting embryonic stem cell research.
We have support from two of our colleagues who were very active on
the pro-life side, former Senator John Danforth and former Senator Ben
Nighthorse Campbell.
On the strictly personal level, I have noted the declaration by
President Nixon in 1970 when he declared war on cancer. Had that war
been pursued with the same diligence we pursue other wars, I believe
cancer would long ago have been cured. Without unduly dwelling on my
own situation with Hodgkin's, a year of chemotherapy, I think had the
research been fulfilled, I would have been spared that malady.
The maladies such as heart disease, cancer, Parkinson's, and
Alzheimer's disease strike approximately 110 million Americans a year.
We all know people close to us who have been stricken with cancer or
heart failure. My own chief of staff, Carey Lackman, a beautiful young
woman of 48, was stricken with breast cancer and died 2 years ago. My
son's law partner, Paula Klein, a beautiful woman with two young
children, age 55, died of breast cancer. A Federal judge, Edward R.
Becker, well known to the Senate for his active work for more than 2
years on asbestos legislation, died in May 2006 from prostate cancer
which had metastasized. Those are anecdotal, typical of tens of
thousands, hundreds of thousands of people who have died or are
incapacitated from diseases which could be cured with stem cell
research. It is not only the individuals who contract the maladies, it
is their families. It is their loved ones.
President Reagan's wife, Mrs. Nancy Reagan, who is a very nonpublic
retiring person, has taken a public stand in support of embryonic stem
cell research because of the understanding and impact on her life when
President Reagan had Alzheimer's and she had to care for and watch her
husband suffer from that malady. We have had very extensive indicators,
evidence, that stem cell research could delay the onset of Alzheimer's
and, perhaps, cure it entirely.
The conflict which we have on this issue between ideology and science
is one which mankind has faced repeatedly in the course of our
historical experience. A century from now, people will look back at
this debate on stem cell research and wonder how we cannot possibly
utilize all of the benefits of science to stop people from dying, to
stop people from suffering, when we have these embryos which are either
going to be thrown away or used. They are not going to create living
people. If they were, no one would be suggesting they be used for
scientific research.
There are a number of striking examples of rejection of scientific
knowledge at various stages in our human history which, in retrospect,
are absurd. For example, in 1486, a committee of the Spanish Government
concluded that the voyage proposed by Christopher Columbus should not
be funded because ``the Western Ocean is infinite and perhaps
unnavigable . . . [and] . . . so many centuries after the Creation, it
was unlikely anyone could find hitherto unknown lands of any value.''
Fortunately, Queen Isabella, disagreed.
Galileo was imprisoned for his support of Copernicus' theory that the
planets revolved around the Sun. This allowed the acceptance of a
theory upon which all of modern astronomy and space travel are based
and what we know from our own experience in the solar system.
Michael Servetus has research on human anatomy. Pope Boniface VII
banned the practice of cadaver dissection in the 1200s. This stopped
the practice for over 300 years and greatly
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slowed the accumulation of education regarding human anatomy. Finally,
in the 1500s, Michael Servetus used cadaver dissection to study blood
circulation. He was tried and imprisoned by the Catholic Church.
Anesthesia for women in labor was founded by James Simpson in 1848.
Reporting his discovery that anesthesia could be used to lessen pain
during child birth, the Scottish Calvinist Church objected to the use
of anesthesia during labor because ``pain of child birth was God's
will.'' The Scottish Calvinist Church stifled anesthesia use by
refusing to baptize any children who were born while a person was
anesthetized.
Thomas Edison, who brought electricity to us, had a similar
experience. The Committee on Lighting by Electricity in the British
House of Commons did not believe that electricity was practical,
saying:
There is not the slightest chance of [electricity]
competing, in any general way, with gas. There are defects
about the electric light which, unless essential changes take
place, must entirely prevent its application to ordinary
lighting purposes.
Fortunately, that view did not prevail. Fortunately, since it is 102
degrees today and we have an air-conditioned Senate Chamber.
Vaccines, in 1772, in response to the new science of vaccination,
Rev. Edward Massey declared:
Diseases are sent by Providence for the punishment of sin,
and the proposed attempt to prevent them is a diabolical
operation.
Had vaccines been outlawed, millions of lives would have been lost.
In the 1820s, Dr. Dionysus Lardner, Professor of Natural Philosophy
and Astronomy at University College, London, stated, referring to rail
travel:
Rail travel at high speed is not possible because
passengers, unable to breathe, would die of asphyxia.
If it were true, I would not be here today. I would have had to find
another way than rail travel to come from Philadelphia to arrive in
time for this debate.
I go through this list, and it is only an abbreviation of a much
longer list to show how attitudes at different times in retrospect look
foolish, look absolutely ridiculous.
When we see in our everyday existence the enormous suffering from so
many maladies, there is just no sensible, logical reason why we should
not make use of stem cell research.
When I joined the Subcommittee on Health and Human Services in 1981,
the budget for the National Institutes of Health (NIH) was a little
over $3 billion. With the leadership of that subcommittee, those funds
have now been increased to almost $29 billion annually. We are being
outstripped by other countries which are undertaking embryonic stem
cell research. They are taking our scientists. We have the capacity
with the NIH and the Federal funding to make enormous additional
progress on medical research to save lives, to save pain and suffering.
We ought to do so. We ought to pass the Specter-Harkin bill--the
Senate's version of the House-passed bill--and seek to persuade the
President of the United States that this is a bill which ought to be
signed into law.
I know my 30 minutes is up, so I yield to my distinguished colleague
from Iowa, Senator Tom Harkin.
The PRESIDING OFFICER (Mr. Burr). The Senator from Iowa.
Mr. HARKIN. Mr. President, first, I congratulate Senator Specter on
an exemplary opening statement on this 2-day debate we will be engaged
in and also thank him, as I will in my formal statement, for his
leadership over the past several years on so many issues of health
care, and this one in particular. I am proud to join him in this
effort, as I have for the last year, to try to get H.R. 810 to come up.
Mr. President, we have waited a long time for this day to come, I
think too long. We could have and should have voted on H.R. 810 more
than a year ago after it passed in the House with a strong bipartisan
majority. So we have lost some valuable time. But more to the point,
America's best medical researchers have lost valuable time. But be that
as it may, H.R. 810 has finally come to the Senate floor, and we will
vote on it tomorrow afternoon.
I thank majority leader Bill Frist for brokering the agreement to
make this vote possible. It took courage for him to announce last
summer that he supports the bill. And it took courage for him to
schedule this vote. I have already commended him privately, and I
commend him publicly as well.
Again, I thank Senator Specter for leading the effort to promote stem
cell research for so many years. He chaired the very first hearing in
Congress on embryonic stem cells, as he said in his remarks, in
December of 1998. And, again, just repeating what Senator Specter had
said--but for the sake of emphasis--our Labor, Health, and Human
Services Appropriations Subcommittee has held 18 hearings on this
research since then.
Senator Specter and I also introduced the very first bill in Congress
on stem cell research in January of 2000. So Senator Specter and I have
traveled a long road together, and I thank him for being such an
extraordinary leader and partner in this effort.
I also thank the other Senate leaders on stem cell research: Senator
Hatch, Senator Feinstein, Senator Smith, and Senator Kennedy. Counting
Senator Specter and myself, there are three Republicans and three
Democrats on the list who have led the effort to bring up H.R. 810 and
pass it, and it has been a truly bipartisan effort all the way.
Most of all, I thank the hundreds of thousands of families and
patients who never gave up, who kept up the pressure to bring this bill
to the floor, and who are so eager to see H.R. 810 sent to the
President's desk for his signature. They have kept the faith. Now it is
our job to see they are not disappointed.
Under the UC agreement, we will debate and vote on three bills. But
make no mistake, the only one that really matters is H.R. 810, the Stem
Cell Research Enhancement Act. This is the one bill that, at long last,
will unleash some of the most exciting and promising research of modern
times.
So, as we begin this debate, it is a good time to step back and ask:
Why is there so much support for H.R. 810? Hundreds of patient advocacy
groups have endorsed the bill; so have dozens of Nobel Prize winning
scientists, dozens of research universities, and, I might add, so has
the American public. Polls now show that 72 percent of Americans
support embryonic stem cell research--72 percent--compared with 24
percent who oppose it. That is a 3-to-1 margin. So the American
people--three out of four--are in favor of embryonic stem cell
research.
Why? Well, the answer is very simple. Embryonic stem cell research
offers real hope--real hope--for people with Lou Gehrig's disease, real
hope for people with Parkinson's, real hope for people with spinal cord
injuries, real hope for people with heart disease, real hope for people
with diabetes, real hope for people with cancer, real hope for people
who suffer from autoimmune diseases such as lupus. All told, more than
100 million Americans have diseases that one day could be treated or
cured with embryonic stem cell research. Here is just a brief list of
them: cardiovascular disease, autoimmune disease, Alzheimer's,
Parkinson's, spinal cord injuries, birth defects, severe burns--
millions of Americans who could be cured or helped with stem cell
research.
But it is not just Members of Congress who are saying it; we have
asked top scientists. Senator Specter and I sent letters to the
National Institutes of Health last week. Senator Specter referred to
that in his remarks. We asked their top scientists for their thoughts
on stem cell research. Every single one of them said embryonic stem
cell research offers enormous potential. We asked 19 NIH scientists--
heads of the different individual institutes--and all 19 agreed.
Here is what Dr. Zerhouni, the NIH director, wrote to us:
Embryonic stem cell research holds great promise for
treating, curing, and improving our understanding of disease.
This is from Dr. Elizabeth Nabel, the director of the Heart, Lung,
and Blood Institute. She wrote:
Embryonic stem cell research has vast potential for
addressing critical health [care] needs.
And it is not just NIH scientists who believe this way. In a letter
from Dr. J. Michael Bishop, who won the Nobel Prize in medicine in
1989, he writes:
The vast majority of the biomedical research community
believes that human embryonic stem cells are likely to be the
source of key discoveries related to many debilitating
diseases.
[[Page S7572]]
I could go on and on, but I think you get the picture. Scientists
agree: embryonic stem cell research offers enormous hope--real hope--
for easing human suffering.
Now, some may ask: I thought the Federal Government already supports
embryonic stem cell research. What about the speech the President gave
5 years ago?
Well, let me try to explain the President's policy as was enunciated
5 years ago. He gave the speech on August 9, 2001. I remember it well.
I was listening to it. I was on the road. I was listening to it on the
radio.
The President, at that time, said that federally funded scientists
could conduct research on embryonic stem cells only if the stem cells
had been derived prior to 9 p.m., August 9, 2001. Well, I thought to
myself at the time--and I have thought since--that is rather odd. It is
morally OK to do research on stem cells derived before 9 p.m., but it
is not morally acceptable to do research on stem cells derived after 9
p.m.? Well, I thought to myself, why not 9:05? What about 9:15 p.m. or
9:30 or midnight? Why was 9 p.m. the magic cutoff hour on August 9,
2001?
Well, clearly it was totally arbitrary. That just happened to be when
the President gave his speech. But for whatever reason, the President
said only those lines derived by 9 p.m. August 9, 2001, were eligible
for federally funded research.
At the time, after I checked into it, some of us were hopeful that
the policy would work. But it has not, and here is why. When President
Bush announced his policy, he said 78 stem cell lines were available.
Many people thought 78 stem cell lines might be enough, might have
enough genetic diversity to actually do the kind of research we needed.
But as the years progressed, we found that only 21--only 21--of the
approved lines are actually available for study; not 78, only 21.
We found out something else I did not know at the time. All 21 of
these lines are contaminated by mouse cells. In other words, the
embryonic stem cells were grown on mouse cells, so they are
contaminated, making it highly unlikely ever to be used for any kind of
human therapy. I ask: Would any of you want to have stem cells used for
your illness if they were contaminated with mouse cells? I do not think
so, and neither do the scientists. And the other thing we found out is
that now many of the 21 lines are too unhealthy to use. They have
actually become sick.
Dr. Nabel of the NIH Heart, Lung, and Blood Institute wrote to me
that only four of these lines are in common use--four. Dr. Jeremy Berg,
another NIH director, director of the general medical sciences, said
there are about six lines in common use.
So what is happening now is that these policy restrictions are making
our scientists work with one arm tied behind their back. It is having a
chilling impact on scientists thinking about entering the field.
Dr. Nora Volkow, director of the NIH Drug Abuse Institute, said it is
stifling interest in research. She said:
Despite general interest and enthusiasm in the scientific
community for embryonic stem cell research, the limited
number of available lines has translated into a general lack
of research proposals.
Well, if you are a research scientist at one of our hundreds of
universities around the country, and you are eligible for NIH funding,
would you want to do research on only four lines that may not lead to
anything? Would you put in a proposal to do that? You could be one of
our budding genius researchers. You might want to put your efforts and
endeavors into something else rather than a dead-end policy.
So I submit that the President's policy is not a way forward, it is a
dead-end street. It offers only false hope--false hope; not real hope,
false hope--to the millions of people across America and the world who
are suffering from diseases that could be cured or treated through
embryonic stem cell research.
Meanwhile, hundreds of new stem cell lines have been derived since
the President's arbitrary deadline of August 9, 2001. These lines are
uncontaminated. They are healthy. But they are totally off limits to
federally funded scientists. I do not mean just scientists who work at
NIH; I am talking about all the scientists who work in all of our
universities and research institutions across America. They are off
limits--off limits. They cannot use it. It is really a shame.
I was listening to Senator Specter earlier talk about some of the
earlier pronouncements, some by the Catholic Church, back in the Middle
Ages, some by--he mentioned another Calvinist Church--I don't know who
all he mentioned--but the views at that time and how we look back and
say: How could they have been so blind to prohibit certain activities,
such as using cadavers for scientific experimentation to learn how the
body works so we could perhaps cure illnesses and diseases?
I was listening to that, and I thought: We have new stem cell lines,
uncontaminated with mouse feeder cells, healthy, ready to go.
Scientists cannot use them. And I thought: We do not require
astronomers today to explore the skies with 19th century telescopes. We
do not tell our geologists to study the Earth with a tape measure. If
we are serious about realizing the promise of stem cell research, our
scientists need access to the best stem cell lines available.
And, again, I would not want anyone to take just my word for it. I
think Dr. James Battey knows more about stem cell research than anyone
at the National Institutes of Health. He runs the stem cell task force
there, and this is what he wrote when I asked him whether it would help
our scientists to have access to more stem cell lines. Here is his
direct quote:
The more cell lines available for study, the more likely a
cell line will be maximally useful for a given research, and
potentially clinical, application. For this reason, the
scientific community would be best served by having a greater
number of human embryonic stem cell lines available for
study.
That is from a letter to me from Dr. James Battey, chair of the NIH
Stem Cell Task Force, dated July 13, 2006.
Dr. Volkow of the Drug Abuse Institute was even more blunt. She
wrote:
Access to a wider array of embryonic stem cell lines would
definitely increase scientific opportunity and the chances of
breakthrough discoveries.
I should note that scientists in many other countries around the
world do not face these kinds of arbitrary restrictions. When you talk
to researchers in England, for example, our policy makes no sense to
them. They cannot understand why stem cell lines derived on one date
are fine to use, but if they are derived on another date they are off
limits. They do not have arbitrary barriers like that in England, and
that is a big reason so many of the major advances in stem cell
research are happening there rather than in the United States.
So we need a stem cell policy in this country that offers real,
meaningful hope to patients and their loved ones. That is what H.R. 810
would provide.
Under this bill, federally funded researchers could study any stem
cell line regardless of the date it was derived as long as strict
ethical guidelines are met. I think it is important to run through some
of those ethical guidelines.
First, the only way a stem cell line could be eligible for federally
funded research is if it were derived from an embryo that was otherwise
going to be discarded. As Senator Specter pointed out, there are more
than 400,000 embryos in the United States left over from fertility
treatments that are currently sitting frozen in storage. The moms and
dads have had all the children they want; they no longer need any more
of these embryos, and most of them will be discarded. It happens every
single day at fertility clinics around the country. People have used in
vitro fertilization, had their children, and they don't want any more.
Rather than continue to pay the facility to store them and freeze them,
they call up and say we don't want them anymore. The facility discards
them. It happens every day.
All we are saying is, instead of discarding them as leftover embryos,
let's allow couples, if they wish, to donate them to create stem cell
lines that can cure diseases and save lives. The choice is this: Throw
them away or use them to ease suffering and, hopefully, cure diseases.
It is the second choice that I believe is truly moral and truly
respectful of human life. Again, I have to emphasize, as I will today
and tomorrow time and time again, H.R. 810 does not create any new
embryos. Not one new embryo will be created under H.R. 810--only
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those left over in in vitro fertilization clinics, and only if the moms
and dads give their written consent.
As I said, the second ethical requirement requires them to provide
informed written consent. Again, a lot of people don't realize this,
but the President's policy is a little fuzzy on the matter of informed
and written consent. Some of the 21 federally approved lines--
especially those coming from other countries--don't meet that
requirement. So we need to pass H.R. 810 to tighten the ethical
guidelines on stem cell research, so there is no question that the
embryos were donated voluntarily.
Finally, H.R. 810 prohibits anyone from being paid to donate embryos.
There is no chance under this bill that women could be exploited to go
through the donation process against their will. So no money can change
hands. The three ethical guidelines, to repeat, are: One, we can only
use excess embryos in in vitro fertilization clinics; second, there
must be informed written consent for the donation of those embryos; and
third, no money can exchange hands to pay for any of these.
Let me address one more issue, and that is the matter of the so-
called alternative ways of deriving stem cells. Some opponents of this
will speak today and tomorrow and argue that we don't need to pass H.R.
810. Instead, they say, we should put our current stem cell research on
hold in hopes that some new way of deriving stem cells will pan out
some time, hopefully, in the future.
That would be a tragic mistake. I support any ethical means to
improve the lives of human beings who are suffering. In fact, Senator
Specter and I included language in our appropriations bill last year
urging NIH to support research on alternative ways of deriving stem
cells. But not one of these so-called alternative methods has ever
succeeded in producing a stem cell line. Right now, they are just
theories. Maybe one day, 5 years or 7 years or 10 years or 15 years
from now, one of these methods will pan out. But maybe not.
I think this chart tells the story. The NIH estimates that there are
about 400 stem cell lines worldwide, almost all of which were derived
after the President's arbitrary cutoff date of August 9, 2001. Every
one of these lines was derived the same way, using embryos that were
left over from infertility treatments that would otherwise have been
discarded. So you see on the chart ``stem cell lines derived using
current method,'' and we have about 400 stem cell lines worldwide. Now,
how many lines were derived using unproven alternative methods? Zero.
It is 400 to zero.
Yet we will hear today and, I think, tomorrow from some who say we
should pass other bills. We should not use the proven method we have,
but we should go to alternative methodologies. We know right now that
zero stem cell lines have been derived from using those alternative
methodologies.
Again, should we pursue these alternative methods? Of course. This is
no prohibition against that. We should open every door we can in the
ethical pursuit to cures. But meanwhile, people we love are dying from
Parkinson's and ALS, and children are suffering from juvenile diabetes.
Should we say wait another 5, 7, or 10 years and see if we can derive
stem cells from these alternative methods? Maybe we can, maybe we
cannot. If we cannot, what do we do then? Say the doors are all closed?
Meanwhile, we have many stem cell lines derived from leftover embryos
in in vitro fertilization clinics.
Another point about the alternatives bill. Even if Congress were to
pass it and the President signs it, it has absolutely no impact on the
progress of stem cell research. That is because the other bills we are
voting on here don't authorize anything NIH cannot do already. We had a
hearing. Senator Santorum, the author of that bill, was at the hearing.
We had people from NIH. Senator Durbin was there and he asked the
question:
Can you tell me whether S. 2754--
which is another one of the companion bills we will be voting on
tomorrow--
authorizes research on stem cells at the NIH that currently
is not permissible or legal?
Dr. James F. Battey at NIH said:
No, it does not.
That was on June 27 of this year. So the alternatives bill, S. 2754,
might not do any harm, but it doesn't do any good either. It just says,
NIH, you can do what you can already do. Well, that is fine with me; I
have no problem with that. But don't be fooled into thinking that S.
2754 somehow takes the place of H.R. 810. It doesn't.
That is one more reason we need to focus on H.R. 810.
In closing, my nephew Kelly is one of the millions of Americans whose
hopes depend on stem cell research. He has been a quadriplegic for
about 27 years since suffering a spinal cord injury in a terrible
accident while he was in the U.S. Navy and serving on an aircraft
carrier. Kelly's hope has been that sometime scientists will finally
find a way to mend his spinal cord so he can walk again. He has been
following very closely the whole issue of embryonic stem cell research.
His hope, like the hope of Christopher Reeve's, was--we all remember
him, our first ``Superman''; he fought so hard for embryonic stem cell
research before he passed away. They both hoped embryonic stem cell
research would lead to a breakthrough that would allow them to walk
again. Kelly asks all the time: When is the Senate going to vote on
H.R. 810?
You know, we have seen the videos of mice whose spinal cords have
been damaged so they could not walk and were treated with stem cells
from other mice and they are now walking again. As Christopher Reeve
once said after reviewing the video of one of these white rats that
could not walk but was given stem cells and now was walking, ``Oh, to
be a rat.''
Well, after more than a year of prayers and pressure, my nephew Kelly
and millions of other Americans suffering from disease and paralysis
will get their wish. I am optimistic that we have the 60 votes
necessary to pass H.R. 810 tomorrow and send it immediately to the
President's desk. There are a lot of stories. I am sure we all have
family stories such as my nephew's.
Here is a letter from the ALS Association--the Amyotrophic Lateral
Sclerosis Association, also called Lou Gehrig's Disease. It says, in
part:
The advancement of stem cell research is vital for people
such as Roger Gould from Ames, IA. ALS has steadily eroded
Roger's ability to control muscle movement, limiting his
ability to speak, walk, move his arms, and lead the type of
life most all of us take for granted. Ultimately, the disease
will take his life. Stem cell research provides promise to
people such as Roger and his wife Cindy that one day an
effective treatment for ALS will be found. It also gives hope
to thousands of others that ALS no longer will mean death in
an average of 2 to 5 years after diagnosis; that one day we
may be able to prevent ALS from taking the lives of people
such as Rob Borsellino, a nationally recognized columnist
from Des Moines, IA, who lost his battle against ALS last
month, a year after his diagnosis.
I ask unanimous consent that this letter be printed in the Record
following my statement.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Mr. HARKIN. Mr. President, my time is up. Again, this is going to be
a good debate, a good airing of the issues. Tomorrow we will vote on
this bill and send it to the President. I am hopeful that the
President, after reviewing it and looking at what happened in the
past--the new things that have come to light because of the mouse
feeder cells and the contamination of those lines--will sign the bill
and give real hope to millions of Americans.
I yield the floor.
Exhibit 1
The Amyotrophic Lateral
Sclerosis Association,
Washington, DC, July 12, 2006.
U.S. Senate,
Washington, DC.
Dear Senators: The ALS Association (ALSA) strongly supports
the Senate's consideration of legislation to advance stem
cell research. We are grateful for the bipartisan efforts of
Senators to bring this important issue up for a vote before
the August Congressional recess and are particularly
appreciative of the leadership on this issue demonstrated by
Majority Leader Bill Frist (R-TN) and Senator Tom Harkin (D-
IA).
We understand that the Senate will consider three different
stem cell initiatives during the week of July 17. We strongly
urge the Senate to pass all three proposals, including H.R.
810, the Stem Cell Research Enhancement Act. These
initiatives, and H.R. 810 in particular, provide our nation
with the best opportunity to fully explore the promise
[[Page S7574]]
of stem cell research and the hope that it may lead to a
treatment and cure for ALS.
The ALS Association is the only national voluntary health
association dedicated solely to the fight against Amyotrophic
Lateral Sclerosis (ALS), more commonly known as Lou Gehrig's
disease. Our mission is to improve the quality of life for
those living with ALS and to discover a treatment and cure
for this deadly disease.
ALSA supports the ethical expansion of the Administration's
stem cell policy as provided for in H.R. 810, permitting the
use of embryos originally created for fertility treatment
upon the consent of those individuals for whom the embryos
were created. Importantly, the bill would arm researchers and
scientists with the tools and resources they need to
determine the potential embryonic stem cell research has to
prevent, treat and cure countless diseases. This is
especially important for people with ALS, for there is no
cure for the disease and although there is one drug available
to treat ALS, it only prolongs life by a few months.
The advancement of stem cell research is vital for people
like Roger Gould from Ames Iowa. ALS has steadily eroded
Roger's ability to control muscle movement, limiting his
ability to speak, walk, move his arms and lead the type of
life most all of us take for granted. Ultimately, the disease
will take his life. Stem cell research provides promise to
people like Roger and his wife Cindy that one day an
effective treatment for ALS will be found. It also gives hope
to thousands of others that ALS no longer will mean death in
an average of two to five years after diagnosis; that one day
we may be able to prevent ALS from taking the lives of people
like Rob Borsellino, a nationally recognized columnist from
Des Moines, IA who lost his battle against ALS last month,
just a year after his diagnosis.
Through our innovative TREAT ALS program, The ALS
Association is pursuing an aggressive strategy to advance the
development of new treatments for ALS, bringing innovations
from the lab to the bedside faster than ever before.
Exploring the potential of stem cells is an important
component of this effort. In fact, recent research funded by
ALSA and published in the Annals of Neurology just this
month, shows that stem cell therapy can partially restore
motor function--function which ALS destroys. Other research
in stem cells also show promise for ALS. While translating
the promise of stem cell research into treatments and a cure
for the disease continues to be a hope for the future, it is
important that we explore all potential avenues for treating
this horrific disease. An expansion of the current federal
policy on stem cell research can only benefit the search for
a treatment and cure for ALS.
Therefore, we urge the Senate to pass H.R. 810 and help
ensure that people with ALS can benefit as quickly as
possible from the very best that science and technology has
to offer, including the potential innovations that can result
from embryonic stem cell research.
Sincerely,
Steve Gibson,
Vice President, Government Relations
and Public Affairs.
The PRESIDING OFFICER. Under the previous order, the majority
controls the next 30 minutes.
The Senator from Oklahoma is recognized.
Mr. COBURN. Mr. President, I wish to take 5 minutes of my allotted 15
minutes to answer some of the questions raised by Senator Harkin and
Senator Specter.
I think it is very important that the American public understands
what this debate is. We have heard a lot of statements this morning
that there are no cures other than fetal stem cell research, and that
could not be further from the truth. I am a practicing physician. I
deliver babies. I have read almost every article published in the last
12 months on stem cells, both embryonic and nonembryonic adult. The
fact is there is not one cure in this country today from embryonic stem
cells.
We talked about 21 lines, but what they don't say is there is no
limitation in this country at all on private research from any of the
400 lines Senator Harkin mentioned. There also is a statement by the
caretaker and many scientists that the lines are not contaminated. As a
matter of fact, they are not contaminated. The question is, do we want
to do what is best to get us further down the road to treat people? I
am a two-time cancer survivor; I had cancer of the colon and melanoma.
With the treatments that are available--I desire the treatments that
can come out of stem cell research, there is no question. But every
disease Senator Harkin listed--every disease save ALS--has an adult
stem cell or cord blood stem cell cure that has already been proven in
humans, without using embryonic stem cells. What is the science behind
it? What is the science that tells us we are going to have trouble with
embryonic but not with the other? It is called the mitochondria. If you
study physiology at all, what you know is every cytoplasm of every cell
has mitochondria in it.
The only way to use an embryonic stem cell line and to use it
effectively without falling into the trap of contamination or cross-
immunization--in other words, allergy to the treatment--is to somehow
quiet mitochondria. They are the energy source for cells. They have
DNA. So none of the problems that are seen with your own adult stem
cells or cord blood from your own child will be existing in a treatment
from your own stem cells.
The reason we should spend more money on our own stem cell lines
today is because there will not be complications from them as is noted
in every study that has thus far been done on embryonic stem cells.
The Senator mentioned the rats. The only study that shows neurologic
improvement is when the rats were sacrificed at 8 weeks. Every other
study, when they let the rats live to 12 weeks, show teratoma or tumor
formation, which is the problem with embryonic stem cells.
I hope the American people will listen. It is not about not getting
where we want to go, but there is false hope, tremendous false hope in
what we are about to do when, in fact, if we would redouble our efforts
on the other areas of stem cells.
One final point and then I will yield. There is a germ cell line,
stem cell line, which goes against everything Senator Harkin says. It
has been proven in this country; it has been proven in Germany. It
comes from ovarian tissue and testicular tissue. It is, without a
doubt, the greatest thing on the horizon for us because it has none of
the problems associated--I am not talking the ethical problems, I am
talking the scientific problems associated with embryonic stem cells.
There are none of the problems with it.
I have seen beating heart tissue from germ cell lines. It can create
every area. There are three tissues, endoderm, ectoderm and mesoderm.
That is the important reason why embryonic is thought to be so
important.
One final point on dedifferentiation, the ability to take a cell that
is in your body today and make it go backward. That has been
accomplished. We now see multiple lines of pluripotent cells from our
own bodies.
The choice is not destroy embryos, and if we don't, we will not get
good research; the choice is go where the money is leading us, and the
money is leading us into adult stem cells, germ cell lines, and other
lines that have none of the problems of embryonic stem cells.
The PRESIDING OFFICER. The Senator from Kansas.
Mr. BROWNBACK. Mr. President, I thank my colleague from Oklahoma for
his short, clear statement. I have some charts that will back him up.
I am delighted we are having this debate. It is time. We last debated
this issue on the Senate floor in 1998. A lot has developed since then.
As my colleague from Oklahoma pointed out, much of the science has
passed by the embryonic stem cell and the need for embryonic stem
cells, as the science has gone to adult stem cells and cord blood, and
that is where the treatments are. I will show pictures of patients in
that area and what is taking place.
I am delighted to be debating my colleagues. We have been debating
this issue for some time. I think it is time we have a vote and look at
this issue.
When I was a young Congressman first running for Congress in Chanute,
KS, a young man approached me. He knew me and knew I was running for
office. He said: Can you answer one question for me?
I said: I will try. I was anxious to be of help. I was anxious to
prove I knew policy issues, I knew right from wrong, and I would be a
good Congressman for him.
He asked me: Why is it we will fine somebody up to half a million
dollars for destroying a bald eagle's egg, and yet we will fund the
destruction of young humans? Why is it Federal law, both cases at that
point in time, as far as the funding of abortion--I don't remember when
that was changed, although now we are talking about the destruction of
young human life again.
He said: Why is that?
I thought for a while. I thought: That is a good question. I don't
know why that is.
[[Page S7575]]
I have a picture which may seem an odd place to start this debate,
but it will tie in, and I will show how. I have a picture of a bald
eagle's egg and a bald eagle. If I asked my 8-year-old children what
happens if I destroy this egg, will I get this eagle? they will say:
No, you don't get the eagle if you destroy the egg.
Why not? That egg is not an eagle.
I know, but the egg is the eagle because the eagle comes out of the
egg.
Well, he doesn't look like him.
I know it is an eagle in the egg, and if you destroy the egg, you
don't get the eagle. That is why we say in the Endangered Species Act,
if you destroy this bald eagle's egg, you can have a maximum fine of up
to half a million dollars.
I want to show some other eggs, if I can. These are human embryos,
fertilized eggs. They are fertilized eggs such as this bald eagle's egg
is. This one, Mother Teresa once was a human embryo. JFK was once a
human embryo. Martin Luther King was once a human embryo. Ronald Reagan
was once a human embryo.
Again, I think if we ask ourselves a simple question: If I destroy
this, do I destroy this in the same way? Does it happen? If I destroy
this human embryo--everybody on the Earth was a human embryo at some
time--if I destroy that human embryo, do I somehow go ahead and get to
be here anyway?
The answer, of course, again, if you ask my 8-year-old children, is:
No, you don't get to be here because you destroyed the very start of
your life, you destroyed the beginning of it, you destroyed that
biological entity you were because the same genetic material that was
there was in Ronald Reagan, and it was a unique set of genetic
material, unique to him. The same for Martin Luther King, JFK, or
Mother Teresa, and the billions of people around the world. We all
started as a human embryo, and if you destroy the embryo, you destroy
the person.
It is a unique set of genetic material right after the fertilization
takes place. It doesn't matter where the fertilization takes place. It
can take place in an IVF clinic or the old-fashioned way or it can take
place by cloning. You still have this. You can have this, or you can
destroy this and never get that. That is pretty direct,
straightforward, nobody argues it. And we are not talking theology, as
people try to drag this into the debate. We are talking basic biology.
This is basic biology 101. If you destroy the embryo, you don't get the
full-scale person. This is a genetic person, entity, special, unique,
sacred, and so is this person.
My point one of this is, if we use taxpayers' dollars to fund the
expansion of embryonic stem cell research, you have to inherently
destroy young humans to do this, and do we want to do that? What was
previously said in Dickey-Wicker was: No, we will not use taxpayers'
dollars to destroy young human life. Here we would change that and say:
Yes, we do; it is for a special purpose, a special reason; these are
unique; these are something we are really going to get cures for. And
that is my second point, cures.
The other side has talked about cures for a long period of time, and
I want cures, and we are getting cures to take place. If we had taken
the half a billion dollars, $500 million that we have invested in
embryonic stem cell research in animals and humans and invested that
instead in adult stem cell research and cord blood research, we would
probably have a lot more people in clinical trials today. We would have
a lot more people, I believe, being treated and alive today if we had
taken the half a billion dollars that we put, in the last 5 years, into
these areas of embryonic stem cell research and put them in adult stem
cells and cord blood, we would have more people alive today, walking
around, experiencing treatments and I believe cures. Let me show some
faces of these people.
This is a beautiful lady, Jacki Rabon. She was involved in a traffic
accident. She is a paraplegic. She had to go to Portugal to get a
treatment with her own adult stem cells. They are olfactory stem cells
from the base of the nose. They take them out, grow them, and put them
back in the spinal cord injury area. She had no feeling, no mobility,
nothing below the waist. She is now getting feeling in her hips through
this treatment, adult stem cells, her own stem cells. She is getting
feeling in the hips and walking with the use of braces, but she had to
go to Portugal to do this. Why isn't this being done in America? Why
aren't we having people treated here? We are not adequately funding
this area. She wants to walk and I want her to walk and she could, but
we are taking money and putting them into these speculative areas when
we have cures that are working. We have to go to Portugal to get them.
Let's look at this next picture. This is an amazing story. This young
man is named Ryan Schneider. I hosted him at a press conference 2 hours
ago. He is 3 years old, a young man with cerebral palsy. His mother
saved his cord blood.
At 2 years of age, she started noticing that he was not growing and
that his arms were retracting. She took him to the doctors and they
said: Yes, CP; he has CP. The mother was devastated, but she would not
give up.
The morning after the diagnosis, she was lying in bed and she had
this a-ha moment. She said: I saved his cord blood and let's use the
cord blood and treat him with the cord blood because I think that can
work and get him moving again.
She called all around the country and couldn't find anybody willing
to do this procedure. She was pleading with these doctors: It is simply
his own cord blood, taking his own cord blood and putting it back in;
this isn't going to hurt him.
They said: We can't do it, not sure, we don't have FDA protocol.
Finally, she finds a researcher at Duke University, whom we had in to
testify, who said: Yes, we will do it, and the worst thing that can
happen is nothing because nothing will happen, it is his own cord
blood; it is not going to hurt him.
She goes down to Duke University, takes his own cord blood, and they
inject it in him. This is when he was 2. He was at a press conference
today. There is no retraction taking place in the arms. He has full
mobility. The thing he likes to do the most is bug his 8-year-old
sister, which is what his mother said today: We like that, too, that he
wants to do that. He has a word vocabulary that is normal for the age
range. She said: Why isn't this an FDA-approved situation? Why are we
not doing more research? Why aren't more people storing and saving cord
blood so when this happens people can get cures?
Well, we haven't put enough funding into it. If we had put the half a
billion more dollars into this area instead of embryonic, we might have
a bunch of kids treated for CP who are not getting treated and be like
Ryan running around and bugging his sister instead of having CP.
Here is a real interesting story, too, Keone Penn. We had him in to
testify. He has sickle-cell anemia. He was dying. It is a real
difficulty. Sickle cell is a very difficult problem to face, very
painful problem for a child to face. He went through the New York Cord
Blood Center, got treatment there, got a match. They had enough of a
genetic match that it works for him. There are no indicators of sickle-
cell anemia today. None. He isn't in Washington today, but we have had
him in to testify.
We need a lot more cord blood stored. We need a lot more diversity of
cord blood stored. We could use that half a billion dollars to store
more cord blood and have more ethnic diversity so more people can get
treated, so more people such as him will live, not die; so more people
will not have to suffer what he went through. There could be real
treatments with these dollars to help them.
No. 1, why are we destroying young human life? We fine people for
destroying life in other forms that we want to preserve, such as the
bald eagle. No. 2, why would we take this money away from current areas
where we can really treat people and especially in the areas where we
are not getting any treatments, we are having all the problems with
tumor formation, as Dr. Coburn noted. Why are we doing that? So that
fewer people are getting treatments and people are having to go
overseas to get these treatments? Why? And why would we ask to do more
of it now? That is what this bill is basically asking to do: That we
would change Federal law so you could destroy human life with Federal
taxpayer dollars. No. 2, that we would use this money, and more of it,
to fund speculative areas
[[Page S7576]]
that even their set of scientists are saying are a minimum of a decade
or two away from treatments which we are not getting, and we have taken
away from Keone Penn, and treatments that he could get. Why? What sense
does that make?
In 1943, C.S. Lewis delivered a series of lectures--this is the
gentleman who did the Narnia series that has been made into a movie
that a lot of young people have seen and read the Narnia series books,
along with a lot of other pieces--a brilliant writer and a brave man.
He did a lecture series called ``The Abolition Of Man'' in 1943, a very
forward-looking series, and he noted at one point: ``If man chooses to
treat himself as raw material, raw material he will be.'' It echoes
themes of what we are hearing today. I don't give anybody over to a bad
heart. I think everybody wants cures. I want cures. I see a way we can
get treatments and hopefully cures. I want things done ethically. I
don't give anybody over to a bad heart. But what we are doing is
treating man as raw material--raw material to feed into a system that
we hope will produce some results.
Unfortunately, it is not the first time we have in human history that
we have treated people as raw material. We have frequently, in the
past, subjected the weaker to the will of the stronger, and we have
always regretted it afterwards. We shouldn't do that today. It
shouldn't have happened then, and we don't need to do it now. We are
talking about the embryo, the young human life.
I want to go through a couple of these points about what it is we are
talking about. President Clinton's bioethics board defined young human
life--and I want to give their definition for it. The National
Bioethics Advisory Commission says that an embryo is: ``The developing
organism from the time of fertilization''--the time of fertilization--
``until significant differentiation has occurred, when the organism
then becomes known as a fetus.'' So it is an embryo by that
Presidential advisory bioethics analysis.
And here is a definition taken from a textbook, the Human Embryology
textbook states:
Although life is a continuous process, fertilization is a
critical landmark because, under ordinary circumstances, a
new, genetically distinct human organism is thereby formed.
The combination of 23 chromosomes present in each pronucleus
results in 46 chromosomes in the zygote.
Thus the diploid number is restored and the embryonic
genome is formed. The embryo now exists as a genetic unity.
That isn't Sam Brownback saying this, this is Human Embryology, Third
Edition, saying that.
We have a distinct genetic entity once it is formed. It doesn't
matter the location. It can be the old-fashioned way, as I noted at the
outset, via the human body; in vitro fertilization; it can be what some
refer to as somatic cell nuclear transfer, SCNT, or what most refer to
as human cloning. It is a separate entity.
Pioneer stem cell researcher Jamie Thompson goes further. He says of
human cloning: ``By any reasonable definition, you're creating an
embryo. If you try to define it away, you're being disingenuous.''
Jamie Thompson. So we are talking about a human embryo.
Now, some would say it is not big enough to be human life. Here I
want to make a point, on this chart, if I could. My colleagues made the
point that the human embryo is about this big; very small at its
beginning of life. Therefore, because it is small and is fragile and it
can't do anything on its own, you know, it is really not human life.
And we should be able to destroy it, for a good purpose. We are doing
this for a good purpose. This isn't us being malicious; we are doing
this for a good purpose. Well, the interesting thing about that, as I
said at the outset--of course, when you destroy this, you never get the
full human at any point in time. This is a separate genetic entity,
even at this point in time. Also, the point was made to me one time
that if the Big Bang theory is correct, then at one point in time, this
is the size of the universe. Then it is all condensed down, this much
matter is condensed down to that infinitesimal, small size before it
blows. So I guess if you destroy it then, it doesn't become the
universe, but that doesn't matter. It is too small to be seen as
significant, and it can't do anything on its own. It sits in a frozen
state, and because it can't take care of itself, because it can't grow,
because it can't breathe in this situation, then it is not human--
because it can't care for itself, because it is too fragile. It doesn't
breathe. It doesn't do some of the things that we give over to the
presence of life.
I want to give some examples, real quick, of young people--let's use
this one. This is Isaiah Sullivan Royal, born to Hannah and Jed Royal.
Hannah works in my office. Isaiah was born significantly premature. As
you can see, he is a fighter. He is a tough little guy. He has been
through a lot--more medical treatments than most people would have gone
through in their lifetime already. Without human intervention, without
help, he doesn't survive and make it. Yet he is a young human, and he
is beautiful. Talk to his parents about him. So the idea that just
because of smallness, you can't take care of yourself doesn't make you
human, is completely false. Do we want to say that because you are
young and small and weak, you are worthless or helpless or you are not
human, which would be even worse? That just doesn't stand. That doesn't
stand to reason. Yes, human life is fragile, but it is of infinite
worth and it is of infinite value.
I want to now look at the overall issue of where we are with adult
stem cell work. Dr. Coburn hit on this area, and I want to put some
more points to it. We have, by peer review articles, 72 different
areas, different human maladies being treated with adult stem cells or
with cord blood--72. There was recently an article in one of the
magazines saying: Well, we don't think the number is actually 72, it
may be 68, it may be this or that.
We can wait a day or two and it will be up to 72 because there are
more coming out in all of the areas. Some people are quibbling and
saying: Well, these are not in FDA treatment trials. That is true, a
number of them are not because we don't have sufficient funding. A half
a billion dollars would really help us to move that along to get these
in FDA treatment trials. These are in human clinical applications,
where there are human beings treated for 72 different maladies by adult
stem cells or cord blood--72, and for embryonic, we have zero.
We have known about embryonic stem cells in mice for 25 years. We
have not been able to get them to work in this situation. They form
tumors and they are rapid growing. With adult stem cells we know what
they are about, we know what they are doing, and they are working, and
people are being treated: 72 adult stem cell treatments to zero
embryonic treatments. Again, you can quibble that they are not in FDA
trials, not available to everybody. That is true. A lot of people are
having to go overseas for treatments in some cases, and in some cases
they are actually treatments that were developed in the United States,
but because of FDA approval processes being long, they are having to
get treatment overseas, even though the process was developed here.
I want to show you the specific areas, and this is--I am breaking the
rules on charts because this one has--this one is too busy, but it is
the only way I can get it all on one chart: 72 current human clinical
applications using adult stem cells.
As I said, we could wait a week or 2 weeks, it will be more. Here are
some of the amazing ones: Bladder diseases, they are developing,
actually growing bladders with your own stem cells for people who have
had bladder cancer or something of that nature, they are able to
actually form a shell structure and the cells grow around it. The ones
I like the best are in the heart areas, the cardiovascular. I had David
Foege speaking at a press conference we had, he could hardly walk,
advanced stroke, because of his heart problem, no infracturing rate.
The physicians--I am sure I am butchering the words--I am a lawyer. I
apologize for that. But he got this treatment, and he went first to a
place in the United States, and they said: Look, you are just too
advanced in your problematic stage. We are not going to treat you here
because we want to treat early on and we only have so much money and we
could use more, but we only have so much.
So the guy goes to Thailand for the treatment--it may have been
developed in the United States. I am not certain that it was developed
in the United States, but it is used here but only on
[[Page S7577]]
people with great opportunity to make it through. He goes to Thailand,
gets this treatment. His indicators of what happened to him in the
stroke are diminishing. He is out walking. He spoke at the press
conference that we had, and this man has got life again. Otherwise, he
would, in all probability, be dead today. And how many people are like
him, that because we have slowed the development of the adult field
down by putting so many of our resources in the nonproductive embryonic
area, and we are getting interesting science, but with adult we are
talking about real people now. We are talking about real lives of
individuals. How many more of them can get treated, and how many people
can afford to fly to Bangkok to get this treatment? How many are able
to do that? Yet they could go somewhere in the United States. I mean,
my goodness, I hope we start thinking about the people involved in this
and seeing the success in so many various and different fields. I think
it is important we would do that.
Mr. President, I want to point out we will have, as my colleagues
know, three votes that will be taking place. I do hope people will
support the fetal farming ban. We shouldn't be growing young fetuses
and using them for research, period. Some people are wanting to grow
them further, cells differentiate and use it then. What we are talking
about is an actual ban on that. I am hoping my colleagues will support
that because we should not be doing that. I hope everybody would see
that there is a huge moral dilemma with doing that. It is a bill that
will be put forward. There is an alternative bill coming up with these
pluripotent cells that I am hoping my colleagues can support.
The focal point is this, do we use taxpayer dollars, Federal taxpayer
dollars, to destroy young human life for research purposes? I would
hope it is seen that we could develop and put forward a very clear
argument and rationale as to why you shouldn't do that. It is illegal.
The Dickey-Wicker appropriations language, to start off with, that is
the law we previously passed. It is immoral. We shouldn't use a weaker
person for the benefit of a stronger person. And it is unnecessary.
That is actually the beauty of it. We are presenting false choices to
people. The choice that works has no ethical problem, and we can get
broad-based support for it. Then, we can have more Jacki Rabons, Ryan
Schneiders, and Keone Penns who are getting treatments now, and their
lives are being saved, people staying in the United States for
treatment rather than going overseas for the treatment, and we have got
a lot of people being successfully treated and hopefully cured.
I may use that term ``cured'' too loosely because these are at the
early stages. These are treatments that are showing enormous promise,
but we can't--they are not, many of them are not in any sort of FDA-
approved trial, so we can't use that term ``cure.'' But we have a lot
of successes.
The other road that is being talked about is the use of human life as
raw material, and if we do that, raw material we will be. We will
cheapen life. And we cheapen life any time we use it for anything other
than the sacredness that life is. I hope, at the end of the day, that
would be the thing we grab onto. Clearly, embryonic stem cell research
is unnecessary. We don't want to cheapen human life.
Mr. COBURN. Mr. President, would the Senator yield for a question?
Mr. BROWNBACK. I am happy to yield.
Mr. COBURN. Is there any prohibition in the United States today for
private money to fund any type of fetal research, embryonic stem cell
research?
Mr. BROWNBACK. Reclaiming my time, no, there is not. There is no
limitation today on State dollars, private dollars, foreign dollars,
whatever you want to call it.
Mr. COBURN. As a matter of fact, California passed, I think,
Proposition 71: $500 million over the next 10 years in fetal stem cell
research?
Mr. BROWNBACK. I think actually the number is $3 billion.
Mr. COBURN. Three billion dollars. So there is no limitation at the
present time.
Mr. BROWNBACK. None whatsoever.
Mr. COBURN. Is the Senator aware of the private investment dollars
that are presently--the private investment dollars--not Government
dollars, not State dollars--that are now going into embryonic stem cell
research versus adult stem cell and germ line stem cell and cord blood,
the ratio is about 100 to 1?
Mr. BROWNBACK. Mr. President, reclaiming my time, it is, and it is a
very interesting feature that where the private money is going, where
people have to show production coming out of it, it is all going into
the adult cord blood because people know the science. And that is why I
want to conclude with what I started with.
In many respects, the science has passed this debate by. The science
is saying: Do the adult, do the cord blood. The embryonic is not
working, and you have enormous ethical problems with doing that, and we
don't need to go that way. That is where the private dollars then are
going, which I would hope my colleagues would look at as well.
Mr. President, I yield the floor.
The PRESIDING OFFICER. Under the previous order, the minority
controls debate for the next 30 minutes.
Mr. LEVIN. Mr. President, I don't know if there is a fixed order for
the minority. If not, I will yield myself 15 minutes.
The PRESIDING OFFICER. The Senator from Michigan is recognized.
Mr. LEVIN. We stand at the threshold of a new era of medical
discovery. We can already glimpse the dramatic lifegiving advances in
regenerative medicine that lie ahead, but we remain mired down at this
point with breakthroughs on the horizon but not within reach unless we
change the President's policy on stem cell research.
Embryonic stem cell research could hold the key to curing diseases
that no other research can cure. As best we know now, an embryonic stem
cell is unique in nature. It and it alone can develop into any other
type of cell in the body. An embryonic stem cell and an embryonic stem
cell alone can become a nerve cell, a muscle cell, or any of the more
than 200 types of cells in the body. The research into directing the
creation and use of these cells may be extraordinarily difficult, but
it is easy to understand how creating healthy cells could replace
diseased cells and could save an untold number of lives.
One example of the possibilities of stem cell research is the hope
that it offers for those suffering from Parkinson's disease.
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 or 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.
And if those neurons can be successfully transplanted into a patient
with Parkinson's disease, that person could be cured.
The list of other diseases ripe for stem cell research is long. Lou
Gehrig's diseased is a progressive neuromuscular disease characterized
by a degeneration of the nerve cells of the brain and spinal cord.
Juvenile diabetes is an autoimmune disease in which the immune system
attacks the pancreas, destroying insulin-producing cells.
Alzheimer's disease is a form of dementia that afflicts the part of
the brain that controls memory, language, and thought. Spinal cord
injuries interrupt the sensory pathway between the brain and the rest
of the body.
Now, imagine if embryonic stem cell research could produce
replacements for the nerve cells ravaged by Lou Gehrig's disease, for
the insulin-producing cells destroyed by diabetes, for the brain cells
washed away by Alzheimer's, for the neural pathways severed by spinal
cord injuries. Stem cell research could offer the millions of Americans
suffering from these and other diseases not just hopes but cures. It
could give them and their families--who are often physically,
financially, and emotionally exhausted--their lives back.
Many technical hurdles stand in the way of that day. These
discoveries will not be easy. But it is wrong to throw additional and
unnecessary obstacles
[[Page S7578]]
in front of our doctors, researchers, and scientists. That is
precisely, however, what the President's policy has done.
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 only 80 stem cell lines, a totally
inadequate amount, would be available for Federal research. Even worse,
most of those 80 lines were determined to be polluted and unusable,
leaving only about 20 stem cell lines actually available to scientists.
That number is far too small to tap the vast potential of this
research.
The President did not question the legitimacy of the science being
used in stem cell research but the ethics of using embryos,
scientifically known as blastocysts, until implanted through in vitro
fertilization. A blastocyst consists of around 150 cells, which is
smaller than the point of a pin. While the blastocyst is destroyed
during the process of extracting embryonic stem cells, the key fact is
that any that are used for stem cell research would have been discarded
and destroyed anyway. That is a fact that opponents refuse to deal
with.
These blastocysts are created by in vitro fertilization clinics and,
for a variety of reasons, will not be used for implantation and will,
therefore, eventually be discarded.
Last month, the Detroit News editorialized against a Michigan law
restricting embryonic stem cell research and used words that equally
apply 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.
The logic of some embryonic stem cell research opponents is totally
befuddling. They are apparently willing to ignore the discarding of the
embryos by fertility clinics, but they label as morally objectionable
the lifegiving use of embryos which would otherwise be discarded. I
believe that embryonic stem cell research is truly a lifegiving, not a
life-destroying, process because of the extraordinary potential for
healing living, breathing human beings who have names and faces and
loved ones.
While the President is fighting against research in America, other
countries are pressing ahead. America has always been at the forefront
of scientific innovation, and we could do this research faster, more
efficiently, and more ethically than most other countries. We also have
an obligation to speed its potential benefits to the American people
and to people around the world.
The President's policy, however, has stifled private-public
partnerships and has hindered our potential impact in this area. Today,
other countries are poised to reap the lifegiving rewards of stem cell
research while we fall further behind.
Over a year ago, the House took a significant step toward overcoming
Presidential opposition by passing the Stem Cell Research and
Enhancement Act, H.R. 810, which would remove the President's arbitrary
prohibition against using stem cells created after August 21, 2001.
That is another fact that opponents refuse to deal with. The
President's date of August 21, 2001, is breathtakingly illogical. How
can the President argue that it is OK to use embryos created before
that date for research, even though in his view it was the taking of a
life but that after that date it is unethical to do so?
H.R. 810 would pave the way for hundreds or thousands of additional
stem lines to be made available. It is bipartisan legislation, and it
passed overwhelmingly in the House.
Shortly after the House made its strong statement in favor of
exploring the medical potential of embryonic stem cell research, the
Senate majority leader committed to bringing that bill up for floor
consideration. Senator Frist understands how great the life-enhancing
possibilities are, and he has chosen to side with his fellow physicians
and with the future in supporting this research.
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 200 additional
organizations. More important, it has the overwhelming support of the
American people. If the President vetoes this bill, I hope we will
resoundingly override his veto.
As part of the unanimous consent agreement to consider this
legislation, we are considering two additional bills as well. The bill
put forward by Senators Santorum and Specter would emphasize the use of
adult stem cells instead of embryonic stem cells. Adult stem cells may
have some potential, but they do not have the critically essential
ability of the embryonic stem cell to become any other type of cell.
Dr. Sean Morrison, the director of the University of Michigan's
Center for Stem Cell Biology, and one of the top stem cell researchers
in the country, wrote recently in the Detroit Free Press about another
alternative to embryonic stem cells being touted, adult stem cells from
umbilical cords. Dr. Morrison wrote:
Umbilical cord cells are used clinically only to replace
blood-forming cells. There is no compelling evidence that
these cells could ever be used to replace cells in other
tissues. These cells are not an alternative to embryonic stem
cells, which can replace any cell type in the body. . . .That
is why there is near universal agreement among respected
scientists and patient advocacy groups that current
restrictions [against embryonic stem cell research] should be
relaxed.
We may be on the cusp of one of the greatest miracles in the history
of medicine. The door of possibility is ajar, inviting us to enter. But
we cannot make these great strides if our researchers continue to be
hampered by President Bush's overly restrictive policy. We owe it to
everybody suffering from--or who may in the future be afflicted by--
these dread diseases to move boldly toward a brighter future.
I yield the floor.
The PRESIDING OFFICER. The Senator from South Dakota is recognized.
Mr. JOHNSON. Mr. President, today I speak in support of legislation
this Chamber has been waiting to consider for more than a year. I am
pleased that wait is finally over. I encourage my colleagues to join me
in voting to give hope to millions of Americans living with diseases
for which embryonic stem cell research offers their only real hope of a
cure. These patients are often desperate and have been waiting for
their Congress to take action for nearly 5 years, since August 9, 2001,
when the President defied common sense and stifled the promise and the
hope offered by stem cell research.
This essential legislation has already passed the House of
Representatives by an overwhelmingly large bipartisan majority. Today,
I want to briefly share my thoughts on why the current policy on stem
cell research is unsustainable and woefully inadequate, clarify some
misconceptions about the Stem Cell Research Enhancement Act, and share
the stories of some South Dakotans who will enormously benefit from the
passage of this bill.
Current law allows federally funded research on only those stem cells
derived as of August 9, 2001. At the time, there were more than 65 stem
cell lines available worldwide. While this number represented marvelous
progress from the first derivation of an embryonic stem cell in 1998,
we know now that it was just the tip of the iceberg of possibility.
Today we know only 22 of those first 65 lines are viable for
research, and virtually none will produce medical therapies permitted
for use in humans. This is because at the time the only way to maintain
stem cell lines was to use mouse cells to help them grow. Since then,
scientists working with private funds--and no thanks to the Federal
Government--have developed stronger and more robust stem cell lines
that are not dependent on mouse cells and could lead to therapies for
actual use in humans.
We must open these new lines to research supported by Federal
funding. The United States is home to the world's largest and most
distinguished organizations dedicated to maintaining and improving
health through medical science. The National Institutes of Health and
the Centers for Disease Control and Prevention conduct research that is
critical to understanding
[[Page S7579]]
human disease and its treatment. These centers rely on Government
funding to continue their work, and if we do not fund their research on
embryonic stem cell lines, the United States will fall behind the rest
of the world in scientific and medical advancement. If the Stem Cell
Research Enhancement Act does not become law, we not only risk the
futures of Americans living with currently incurable diseases, we also
risk our national reputation as the home of the world's most innovative
and distinguished scientists working to improve the health.
This is not just a matter of international medical research prestige;
it directly goes to the millions of families around the world who will
at last have hope that we can conquer the planet's most awful diseases
and injuries.
The Stem Cell Research Enhancement Act creates a closely monitored
and controlled stem cell research effort. The bill will allow vital,
life-giving research to progress using frozen fertilized embryos that
would otherwise be incinerated as medical waste. The choice is simple:
life-giving research or incineration of excess cells.
Stem cell research is conducted with egg cells fertilized in a
laboratory for the sole purpose of assisting childless couples who wish
to have a baby. After choosing embryos for implantation in the mother,
the remainder are routinely destroyed as medical waste. I believe these
cells, of which hundreds of thousands are now stored at fertility
clinics, would be better used to advance medical research that holds
great promise for curing or preventing some of the world's worst
diseases, as well as for repairing spinal cord and other injuries. I
believe choosing research over incineration is a moral choice.
My South Dakota values, my religious faith, and my commitment to
South Dakota families tell me we must choose life-giving research over
incineration of these cells.
The Stem Cell Research Enhancement Act imposes tighter ethical rules
than exist under current law. Any donated embryos must be created
solely for fertility treatment and must be in excess of the clinical
need of those seeking fertility treatment. Furthermore, the bill
requires written consent from those who wish to donate the embryonic
cells and prohibits financial incentives for donation.
Stem cells in umbilical cord blood have provided effective therapies
for diseases such as leukemia and sickle cell anemia. However, there
are many other diseases, including type 1 diabetes, Alzheimer's, and
Parkinson's, which doctors cannot treat or cure with cord blood stem
cells. Because of this fact, we must advance research in other areas,
including embryonic stem cell research, to access all available options
for curing the debilitating diseases plaguing so many of our fellow
Americans.
Earlier, I mentioned that this bill gives hope to millions of
Americans living with diseases for which embryonic stem cell research
offers the only hope for a cure. I have been honored to meet many of
these individuals in my home State of South Dakota.
This bill gives hope to 3-year-old Alexander Sohl from Brandon, SD.
His parents, Terry and Laurie, told me little Alexander's very first
words were not ``mommy'' or ``daddy'' but ``no shot''--his insulin
treatments began when he was just a baby. And it is stem cell research
that gives his family hope that the daily inflicted pain and the threat
to the very life of this small child can at last end.
This bill gives hope to Bonnie Younkin. Bonnie lives in Huron, SD,
and was diagnosed with Parkinson's disease in 2002 when she was in her
early 50s. Though living with her disease is a daily battle, Bonnie
also serves as an advocate for awareness of the disease and increased
funding for Parkinson's research as the State's action coordinator. It
can run in families; Bonnie is the fourth female in her family
diagnosed with Parkinson's, and she lives in fear that her three
daughters and one granddaughter may have a similar diagnosis in their
future. Bonnie called my office last week, to touch base in advance of
this debate. Upon hearing that I remained committed to supporting this
bill, she had just two words, ``Bless you.''
South Dakota families are desperate for this research to commence--
and to proceed.
Choosing research over incineration is a moral choice. I have prayed
about this issue, and my deeply held religious faith tells me that
respect for human life, respect for God's children, requires this life-
saving research to proceed rather than the continued incineration of
frozen excess embryo cells that are sitting in fertility clinics
classified as medical waste.
Let there be no mistake: There are three bills being considered by
the Senate this week. But unless a Senator votes for H.R. 810, the Stem
Cell Research Enhancement Act, he or she will not have voted for this
meaningful life- giving research.
I urge my colleagues to join me in affirming that respect--that
respect for life--by voting for the Stem Cell Research Enhancement Act.
Choose research and life over incineration.
I yield the floor.
The PRESIDING OFFICER. Under the previous order, the minority is
recognized.
Mr. HARKIN. Mr. President, I have a letter from a number of different
groups endorsing H.R. 810. It is patient advocacy groups, health
organizations, research universities, scientific institutes, religious
groups, and others. There are 205 groups listed here. I will not go
through all of them, obviously, but I think it is important that all of
these groups be laid upon the Record. I ask unanimous consent that the
letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
July 14, 2006.
U.S. Senate,
Washington, DC.
Dear Senator: We, the undersigned patient advocacy groups,
health organizations, research universities, scientific
societies, religious groups and other interested institutions
and associations, representing millions of patients,
scientists, health care providers and advocates, write you
with our strong and unified support for H.R. 810, the Stem
Cell Research Enhancement Act. We urge your vote in favor of
H.R. 810 when the Senate considers the measure next week.
Of the bills being considered simultaneously, only H.R. 810
will move stem cell research forward in our country. This is
the bill which holds promise for expanding medical
breakthroughs. The other two bills--the Alternative
Pluripotent Stem Cell Therapies Enhancement Act (S. 2754) and
the Fetus Farming Prohibition Act (S. 3504)--are NOT
substitutes for a YES vote on H.R. 810.
H.R. 810 is the pro-patient and pro-research bill. A vote
in support of H.R. 810 will be considered a vote in support
of more than 100 million patients in the U.S. and substantial
progress for research. Please work to pass H.R. 810
immediately.
Sincerely,
Accelerated Cure Project for Multiple Sclerosis;
Affymetrix, Inc.; Alliance for Aging Research; Alliance
for Stem Cell Research; Alpha-1 Foundation; ALS
Association; Ambulatory Pediatric Association; American
Academy of Neurology; American Academy of Pediatrics;
American Association for Cancer Research; American
Association for Dental Research; American Association
for the Advancement of Science; American Association of
Neurological Surgeons/Congress of Neurological
Surgeons; American Autoimmune Related Disease
Association; American Brain Coalition; American College
of Neuropsychopharmacology; American College of
Obstetricians and Gynecologists; American Council on
Education; American Council on Science and Health;
American Dental Education Association.
American Diabetes Association; American
Gastroenterological Association; American Medical
Association; American Medical Women's Association;
American Pain Foundation; American Parkinson's Disease
Association (Arizona Chapter); American Parkinson's
Disease Association; American Pediatric Society;
American Physiological Society; American Society of
Clinical Oncology; American Society for Biochemistry
and Molecular Biology; American Society for Cell
Biology; American Society for Clinical Pharmacology and
Therapeutics; American Society for Microbiology;
American Society for Neural Transplantation and Repair;
American Society for Reproductive Medicine; American
Society of Critical Care Anesthesiologists; American
Society of Hematology; American Surgical Association;
American Surgical Association Foundation.
American Thyroid Association; A O North America;
Association for Prevention Teaching and Research;
Association of Academic Chairs of Emergency Medicine;
Association of Academic Departments of Otolaryngology;
Association of Academic Physiatrists;
[[Page S7580]]
Association of American Medical Colleges; Association
of American Universities; Association of Anatomy, Cell
Biology and Neurobiology Chairs; Association of
Independent Research Institutes; Association of Medical
School Microbiology and Immunology Chairs; Association
of Medical School Pediatric Department Chairs;
Association of Medical School Pharmacology Chairs;
Association of Professors of Medicine; Association of
Reproductive Health Professionals; Association of
Specialty Professors; Association of University
Anesthesiologists; Axion Research Foundation;
Biotechnology Industry Organization; B'nai B'rith
International.
Broadened Horizons, LLC; The Burnham Institute;
California Institute of Technology; California
Institute for Regenerative Medicine; Californians for
Cures; Campaign for Medical Research; Cancer Research
and Prevention Foundation; C3: Colorectal Cancer
Coalition; Cedars-Sinai Health System; Central
Conference of American Rabbis; Childrens Hospital
Boston; Children's Tumor Foundation; Children's
Neurobiological Solutions Foundation; Christopher Reeve
Foundation; The CJD Foundation; Columbia University
Medical Center; Cornell University; CuresNow; Cure
Paralysis Now; David Geffen School of Medicine at UCLA.
Duke University Medical Center; Elizabeth Glaser
Pediatric AIDS Foundation; Emory University; The
Endocrine Society; The FAIR Foundation; FasterCures; FD
Hope Foundation; Federation of American Societies for
Experimental Biology (FASEB); Fertile Hope; Fox Chase
Cancer Center; Friends of Cancer Research; Genetics
Policy Institute; The Gerontological Society of
America; Hadassah; Harvard University; Hereditary
Disease Foundation; Huntington's Disease Society of
America; Institute for African American Health, Inc.;
International Foundation for Anticancer Drug Discovery
(IFADD); International Longevity Center--USA.
International Society for Stem Cell Research; Iraq
Veterans for Cures; Jeffrey Modell Foundation; Johns
Hopkins; Joint Steering Committee for Public Policy;
Juvenile Diabetes Research Foundation; Lance Armstrong
Foundation; Leukemia and Lymphoma Society; Lung Cancer
Alliance; Lupus Research Institute; Malecare Prostate
Cancer Support; Marshalltown [IA] Cancer Resource
Center; Massachusetts Biotechnology Council; Memorial
Sloan-Kettering Cancer Center; The Michael J. Fox
Foundation for Parkinson's Research; Mount Sinai School
of Medicine; National Alliance for Eye and Vision
Research; National Alliance on Mental Illness; National
Association for Biomedical Research; National Caucus of
Basic Biomedical Science Chairs.
National Coalition for Cancer Research; National
Coalition for Cancer Survivorship; National Coalition
for Women with Heart Disease; National Council of
Jewish Women; National Council on Spinal Cord Injury;
National Health Council; National Hemophilia
Foundation; National Medical Association; National
Partnership for Women and Families; National Prostate
Cancer Coalition; National Spinal Cord Injury
Association; National Venture Capital Association; New
Jersey Association for Biomedical Research; New York
Stem Cell Foundation; New York University School of
Medicine; North American Brain Tumor Coalition; Northwest
Association for Biomedical Research; Northwestern
University; Paralyzed Veterans of America; Parkinson's
Action Network.
The Parkinson Alliance and Unity Walk; Parkinson's
Disease Foundation; Pittsburgh Development Center;
Project A.L.S.; Pseudoxanthoma Elasticum International
Quest for the Cure; Research!America; Resolve: The
National Infertility Association; RetireSafe; Rett
Syndrome Research Foundation; Rice University Robert
Packard Center for ALS Research at Johns Hopkins
Rutgers University; Secular Coalition for America;
Society of General Internal Medicine; Society of
Gynecologic Oncologists; Society of Reproductive
Surgeons; Society of University Otolaryngologists;
Society for Assisted Reproductive Technology; Society
for Education in Anesthesia.
Society for Male Reproduction and Urology; Society for
Neuroscience; Society for Pediatric Research; Society
for Reproductive Endocrinology and Infertility; Society
for Women's Health Research; Stanford University; Stem
Cell Action Network; Stem Cell Research Foundation;
Steven and Michele Kirsch Foundation; Stony Brook
University, State University of New York; Student
Society for Stem Cell Research; Take Charge! Cure
Parkinson's, Inc.; Texans for Advancement of Medical
Research; Texas Medical Center; The Forsyth Institute;
Tourette Syndrome Association; Travis Roy Foundation;
Tulane University; Union for Reformed Judaism;
Unitarian Universalist Association of Congregations.
University of California, Berkeley; University of
California, Davis; University of California, Irvine;
University of California, Los Angeles; University of
California, San Diego; University of California, San
Francisco; University of California, Santa Cruz;
University of California System; University of Chicago;
University of Illinois; University of Iowa; University
of Michigan; University of Minnesota; University of
North Carolina at Chapel Hill; University of North
Dakota; University of Oregon; University of
Pennsylvania School of Medicine; University of
Rochester Medical Center; University of Southern
California; University of Washington.
University of Wisconsin-Madison; Vanderbilt University
and Medical Center; Washington University in St. Louis,
WE MOVE, WiCell Research Institution, Wisconsin Alumni
Research Foundation; Wisconsin Association for
Biomedical Research and Education; Woodruff Health
Sciences Center at Emory University; Yale University.
Mr. HARKIN. Mr. President, I have a letter from the American Society
for Cell Biology. The letter was sent to Senator Hatch, dated July 17.
It says:
The Senate will shortly be considering legislation to
permit the National Institutes of Health (NIH) to fund
research with additional and new and existing human embryonic
stem cell (hESC) lines. As staunch supporters of biomedical
research and particularly research with hESCs, we trust that
you will exert your influence to ensure passage of H.R. 810.
Scientists engaged in ESC research are counting on you and
like-minded Senate colleagues to assure its passage.
The President must also be persuaded not veto this
legislation for if we continue on the path he set five years
ago, United States investigators will be out of the running
in coverting embryonic stem cells into important new
therapies. It is especially frustrating and demeaning that
American scientists are prohibited from using their NIH grant
funds for research with the hundreds of hESC lines generated
outside the United States or generated in this country with
private funding.
I note there are 27 leading scientists on this letter, 17 of them
having received the Nobel Prize for medicine in one form or another.
I ask unanimous consent that this letter be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
The American Society for
Cell Biology,
Bethesda, MD, July 17, 2006.
Hon. Orrin Hatch,
U.S. Senate,
Washington, DC.
Dear Senator Hatch: The Senate will shortly be considering
legislation to permit the National Institutes of Health (NIH)
to fund research with additional and new and existing human
embryonic stem cell (hESC) lines. As staunch supporters of
biomedical research and particularly research with hESCs, we
trust that you will exert your influence to ensure passage of
H.R. 810. Scientists engaged in ESC research are counting on
you and like-minded Senate colleagues to assure its passage.
The President must also be persuaded not to veto this
legislation for if we continue on the path he set 5 years
ago, United States investigators will be out of the running
in converting embryonic stem cells into important new
therapies. It is especially frustrating and demeaning that
American scientists are prohibited from using their NIH grant
funds for research with the hundreds of hESC lines generated
outside the United States or generated in this country with
private funding.
Also, S. 2754, the ``Alternative Pluripotent Stem Cell
Therapies Enhancement Act,'' sponsored by Senators Specter
and Santorum, seems to us, superfluous. Ostensibly, it is
intended to authorize research ``to derive human pluripotent
stem cell lines using techniques that do not harm embryos.''
However, at present, such research is currently permissible
and, therefore, does not require congressional legislation;
indeed, the National Institutes of Health may currently be
funding such efforts.
Moreover, all the alternative procedures advanced in the
report by the President's Council on Bioethics and other
alternative methods that have been suggested encounter
equally vexing ethical concerns. Hence, S. 2754 is unneeded
and if passed would deflect from the current urgent need for
generating new stem cell lines from excess IVF-derived
blastocysts.
Sincerely,
Peter Agre, M.D., Vice Chancellor for Science and
Technology, James B. Duke Professor of Cell Biology, Duke
University School of Medicine, Nobel Prize in Chemistry,
2003.
Bruce Alberts, Professor of Biochemistry and Biophysics,
University of California, San Francisco, President Emeritus,
National Academy of Sciences.
Mary C. Beckerle, Ph.D., Ralph E. and Willia T. Main
Presidential Professor, University of Utah, President,
American Society for Cell Biology.
David Baltimore, President, California Institute of
Technology, Nobel Prize in Physiology or Medicine, 1975.
[[Page S7581]]
Paul Berg, Cahill Professor of Biochemistry, Emeritus,
Stanford University, Nobel Prize in Chemistry, 1980.
J. Michael Bishop, Nobel Prize in Physiology or Medicine,
1989.
Helen M. Blau, Ph.D., Donald E. and Delia B. Baxter
Professor, Director, Baxter Laboratory in Genetic
Pharmacology, Stanford University School of Medicine.
Michael S. Brown, M.D., Nobe1 Prize in Physiology or
Medicine, 1985.
Linda Buck, Ph.D., Howard Hughes Medical Institute,
Division of Basic Sciences, Fred Hutchinson Cancer Research
Center, Nobel Prize in Physiology or Medicine, 2004.
Johann Deisenhofer, Regental Professor, Investigator,
Howard Hughes Medical Institute, The University of Texas
Southwestern Medical Center, Nobe1 Prize in Chemistry, 1988.
Joseph L. Goldstein, M.D., Regental Professor of Molecular
Genetics and Internal Medicine, University of Texas
Southwestern Medical Center at Dallas, Nobel Prize in
Physiology or Medicine, 1985.
Larry Goldstein, Investigator, Howard Hughes Medical
Institute, Department of Cellular and Molecular Medicine,
University of California, San Diego School of Medicine.
Alfred G. Gilman, M.D., Ph.D., Dallas, Texas, Nobel Prize
in Physiology or Medicine, 1994.
Paul Greengard, Professor, The Rockefeller University,
Nobel Prize in Physiology or Medicine, 2000.
Lee Hartwell, Ph.D., President and Director, Fred
Hutchinson Cancer Research Center, Nobe1 Prize in Physiology
or Medicine, 2001.
Dudley Herschbach, Baird Research Professor of Science,
Harvard University, Nobel Prize in Chemistry, 1986.
H. Robert Horvitz, Professor of Biology, Massachusetts
Institute of Technology, Nobel Prize in Physiology or
Medicine, 2002.
Douglas Koshland, Carnegie Institution, Investigator,
Howard Hughes Medical Institute.
Paul C. Lauterbur, Center for Advanced Study Professor of
Chemistry and Distinguished Professor of Medical Information
Sciences, University of Illinois, Nobel Prize for Physiology
or Medicine, 2003.
Sean J. Morrison, Investigator, Howard Hughes Medical
Institute, Director, Center for Stem Cell Biology, University
of Michigan.
Eric N. Olson, Department of Molecular Biology, University
of Texas, Southwestern Medical Center at Dallas.
Thomas D. Pollard, M.D., Sterling Professor and Chair,
Molecular Cellular and Developmental Biology, Yale
University.
Randy Schekman, HHMI Investigator, Dept. of Molecular and
Cell Biology, University of California, Berkeley.
Phillip A. Sharp, Institute Professor and Center for Cancer
Research, Massachusetts Institute of Technology, Nobel Prize
in Physiology or Medicine, 1993.
Maxine F. Singer, A.B., Ph.D., D.Sc., President Emerita,
Carnegie Institution of Washington.
Harold Varmus, M.D., President, Memorial Sloan-Kettering
Cancer Center, Chair, Joint Steering Committee for Public
Policy, Former Director, National Institutes of Health, Nobel
Laureate in Medicine or Physiology, 1989.
Eric Wieschaus, Department of Molecular Biology, Princeton
University, Nobel Prize in Physiology or Medicine, 1995.
Mr. COBURN. Mr. President, will the Senator yield for a question?
Mr. HARKIN. Yes.
Mr. COBURN. Is the Senator aware of the research that has been done
on juvenile diabetes thus far in terms of embryonic stem cell research
and adult stem cell research?
Mr. HARKIN. I am not intimately knowledgeable of all of the nuances
in research that is being done. We had hearings, and we have the
information in our hearing record on a lot of that. Standing here now,
I don't know all of that.
Mr. COBURN. Is the Senator aware that the only successful treatments
for juvenile diabetes to come from stem cells have come from adult stem
cells, and in fact that the embryonic stem cells have one-fiftieth the
amount of insulin, were not effective, and ended after about 80 days
after transplantation? Is the Senator aware of that?
Mr. HARKIN. Will the Senator repeat that? I was reading something.
Mr. COBURN. Is the Senator aware that of the human studies which have
thus far been done on juvenile diabetes in fact the successful one was
adult stem cells and the unsuccessful one was embryonic stem cell? Is
the Senator aware of that fact?
Mr. HARKIN. Let me respond this way: First, I note that the Juvenile
Diabetes Research Foundation, which represents families all over
America who are affected with juvenile diabetes, is in support of H.R.
810. I want that on the record. In fact, they have been one of the
strongest supporters.
Second, the transplantation of insulin-producing pancreatic cells is
already known to reverse the most damaging symptoms of type 1 diabetes.
The problem with that is the limited number of organ donors out there
who donate pancreases. That seems to be the problem.
Could I ask the Senator, are there enough pancreas donors out there
to take care of everyone with juvenile diabetes?
Mr. COBURN. It is not required. Actually, today the science shows
that ductal cells from the patient's own pancreas can be induced to
become stem cells that then produce insulin-producing cells. There is
no transplantation needed. In fact, these ductal cells have been proven
and demonstrated to produce the same eyelet cells that the patient did
initially when they were grown as an embryo.
Mr. HARKIN. I have heard this argument before. I am not a scientist.
I don't know all of the nuances, I would be the first to admit. I do
know, however, that every time that has come up, the Juvenile Diabetes
Research Association disagrees that this is a viable pathway toward
curing all of those with juvenile diabetes.
Mr. COBURN. They cannot disagree. It has only been done for 3 months,
and it is successful. There have been no successful embryonic cells
taken from the duct of the pancreas of children with diabetes,
converted into cells, and have in fact cured their diabetes.
Mr. HARKIN. How many people have been cured of juvenile diabetes with
this?
Mr. COBURN. For 3 months is all we know. I don't know the numbers. I
think it is eight or nine. This protocol is being done in Europe at the
present time.
Mr. HARKIN. Is it not being done in the United States?
Mr. COBURN. No, it is not being done in the United States.
Mr. HARKIN. Have any of these findings been published?
Mr. COBURN. They have been published in peer-reviewed articles. I
would be happy to submit them for the Record.
Mr. HARKIN. I would appreciate that.
Mr. COBURN. I thank the Senator for allowing me to ask those
questions.
Mr. HARKIN. I thank the Senator. There is a good colloquy.
I would further ask the Senator from Oklahoma--this has been done for
3 months--do we have any data to show that this does cure juvenile
diabetes? Does it abate it somewhat? I don't know what the outcomes
have been for these eight or nine people.
Mr. COBURN. Here is the key point that needs to be made in this
debate: If you use your own cells, you will not have tumors, you will
not have teratomas, and you will not have rejection. If you use
embryonic stem cells, you will have tumors, you will have teratomas,
and you will have rejection.
That is what we know. That is why I, as a scientist, have not raised
the life issue here once, but I am adamantly pro-life. I believe the
science is so far ahead of this debate. When everyone knows what is
really going on in terms of research, they are going to want the
dollars put into the stem cells, both in terms of dedifferentiation--we
know we can differentiate cells backward to make them pluripotent--and
also to isolate cells from our own human body to use back on us. That
is an important part of the debate.
Mr. HARKIN. I thank the Senator.
I again say that all the Nobel scientists, all of the leading
scientists in America simply do not agree with the Senator from
Oklahoma. These are the people involved in cell biology and that kind
of research.
The Senator says embryonic stem cells will produce tumors. We do not
know that is true. We do not have any real long-term data to know
anything about how embryonic stem cells will work later on.
The PRESIDING OFFICER. The time of the Senator has expired.
Under the previous order, the majority is recognized for the next 30
minutes.
Mr. COBURN. I inquire of the Chair, under the previous order, if the
majority is not here, who assumes control of the time?
The PRESIDING OFFICER. The time is reserved for the majority to be
recognized.
Mr. COBURN. Mr. President, it is my understanding that Senator Frist
has this time. He has advised me I can use the time until he arrives.
[[Page S7582]]
The PRESIDING OFFICER. The Senator from Oklahoma.
Mr. COBURN. I will spend a few minutes. This is a very emotional
debate for every family in this country. Every family in this country
has someone who, in fact, has a disease that will be impacted in the
future by research that is ongoing in terms of stem cell research.
I make a couple of points. We have heard today a couple of very
strong statements that are highly inaccurate.
One is that the only way you will cure this is with embryonic stem
cells. No one knows that. As a matter of fact, most of the cures in
science have come not by what we thought was going to happen but by
what happened that surprised us. That is not true.
No. 2, there is no ban at the present time on research in this
country on embryonic stem cells. What there is a ban on is using
additional Federal funds to create additional stem cells, but
additional stem cells can be created outside of the Government.
The Senator from South Dakota created a false choice. The false
choice is not incineration. There are 400,000 embryos that are frozen
in this country today; 93 percent of those the parents want to save for
themselves. So that leaves us a smaller portion. If you look at the
numbers, when you thaw embryos, you have a 50-percent wastage, you lose
50 percent of them. The false choice Senator Johnson put forward was
this: they either get burned up or they get used for embryonic stem
cell research. This last week, the 108th baby was born through this
Operation Snowflake--which is adopted embryos--so that is not the only
choice.
The other thing is, if everyone will recognize, in the fertility
community in this country, that in Europe, they do not have a problem
with excess embryos. We overdo it in this country in terms of creating
embryos for fertility clinics. We create about four times as many
obstetrician and fertility specialists as the rest of the world. The
choice is not incinerate or use for embryonic stem cell research.
The majority leader has arrived. I yield my time.
The PRESIDING OFFICER. The majority leader.
Mr. FRIST. Mr. President, I thank both of my colleagues for the
superb comments thus far over the last 30 minutes but, indeed, since we
started at 12:30 today.
As I opened this morning, I made it clear that this debate would be
the first of the 21st-century dilemmas that involve ethical
considerations and considerations around science, probably the first of
many. I say the first; obviously, we have dealt with some other ethical
issues in medicine over the last 5 years, but much of the discussion
will focus around science and ethics and that nexus, that crossing of
those two, and the interplay.
It is important that we debate this and that all concerns are put on
the table, ultimately. These three bills give that opportunity.
Let me add that this probably will be the first of many debates like
this in the Senate. I know there are a lot of my colleagues who asked:
Why are we bringing this up now? Why are we talking about these tough
issues which do force us to address issues about the distinctions of
life, the early days of life and also the hope and the promise of
science as it goes forward and that interplay? This Senate will have to
get used to it.
This Senate will have to focus on those issues as we move forward
because science, where it used to be growing at a small clip, is now
growing at leaps and bounds, not exponentially but close to
exponentially, and will continue to do so.
Less than a century ago, we did not have antibiotics, we did not have
vaccines. We had measles, mumps, smallpox, polio--all diseases that
ravaged our populations, in this country and around the world. Because
of science, because of public health initiatives, they have essentially
been eradicated. We will see forward momentum. That momentum will be
accelerated in biomedical research.
I mentioned earlier today in opening the debate that when people look
back at the 21st century, I would say maybe the next decade is the
decade of the cells. Much of our discussion is about developmental
biology. That has built upon the foundation of the shoulders of new
knowledge regarding molecular and cellular development, coupled with
the new understanding that is a product of a sequencing of the human
genome from a decade of the last century.
What is important is that the rules, regulations, guidelines, and the
framework must be defined and in large part must be defined by this
Senate. That is our responsibility as Senators, as representatives of
the American people, their attitude, their thought, their philosophies.
They are our constituents.
A second point I made when I first started talking about stem cell
research 5 years ago is we will have to continually assess and then
reassess in light of advancing science certain rules, guidelines, and
regulations we put in place. In part, that is why we are here today.
We have three bills before the Senate. My colleagues have talked
about those three bills: the Fetus Farming Prohibition Act, the
Alternative Pluripotent Stem Cell Therapies Enhancement Act, and the
Stem Cell Research Enhancement Act. Each addresses a different facet of
the issues raised by advancing research, advancing developmental
biology, advancing stem cell research. Each one of them demands
thoughtful consideration and deliberation which will play out over the
course of today and tomorrow.
I spent my entire professional career as a transplant surgeon, a
professional who specializes in moving living tissue from one person to
another person--say an organ or a heart. Take out a heart, put in a
heart. Take out a lung, put in a lung. Thus, my interest before coming
to this Senate focused on many of the same issues that come before the
Senate today: advancing science, how do we define ``brain death,''
something we did in the 1960s, to make transplantation of the human
heart possible.
Thus, it was a little over 5 years ago--on July 18, 2001--that I laid
out a comprehensive proposal, a framework at that time, which I
believed would both promote stem cell research but also provide an
ethical framework through which such research could be conducted. That
was 2001, about 2\1/2\ years after embryonic stem cells had just been
discovered by James Thomson at the University of Wisconsin, or the
human embryonic stem cells.
At that time, 5 years ago, I laid out 10 specific interdependent
principles. The principles dealt with all types of stem cell research--
the adult stem cells, the germ stem cells, embryonic stem cells. They
have helped to guide my assessment of stem cell research over the last
5 years, and they have provided a framework I have used and
consistently gone back and adopted as I looked at various pieces of
legislation on stem cells before this Senate. I will read those 10
principles because of their inclusiveness and their interdependence:
No. 1, ban embryo creation for research.
No. 2, continue funding the ban on the derivation.
No. 3, ban human cloning.
No. 4, increase adult stem cell research.
No. 5, provide funding for embryonic stem cell research only from
blastocysts that would otherwise be discarded.
No. 6, require a rigorous informed-consent process.
No. 7, limit the number of stem cell lines.
No. 8, establish a strong public research oversight system.
No. 9, require ongoing independent scientific and ethical review.
No. 10, strengthen and harmonize fetal tissue research restrictions.
The principles are meant to stand the test of time even when applied
to a field as rapidly changing as stem cell research.
Yes, I do believe both embryonic and adult stem cell research should
be Federally funded but should only be done so within a carefully
regulated, fully transparent, fully accountable framework, ensuring the
highest level of respect for that moral significance of the human
embryo. But we should fund research when it comes to embryonic stem
cell research only if those embryos, only if those stem cell lines were
derived from blastocysts that, with 100 percent certainty, are not
going to be frozen forever, are not going to be adopted but with 100
percent certainty and with appropriate consent would be discarded,
would be thrown away.
[[Page S7583]]
Today, we do debate science, developmental biology, and we debate
ethics. We are called upon to confront the distinctions around life's
early goings when we do so. As my colleagues know, I am pro-life. I do
believe human life begins at conception. It is at this moment, at
conception, that the organism is complete--immature, yes, but complete.
It is genetically distinct, it is biologically human, living.
Development is a gradual process, it is a continual process. All of us
in this Senate were at one time an embryo. It represents human life at
its earliest stage of development. It is a continuum, coming all the
way through. That is the science. That is not religion. That is not
faith. That is the science. Thus, I believe strongly that an embryo
does have moral significance. It needs to be treated with the utmost
dignity and respect.
We have three bills before the Senate. The Fetus Farming Prohibition
Act of 2006, the implantation and gestation of the human embryo into
either a human or an animal for the purpose of aborting for research--
that prohibition is what the discussion is about. Clearly, that would
fall far short of ``utmost dignity and respect.''
The bill before the Senate ensures this practice is never employed in
human research in the United States. That purposeful development of a
human embryo, the manufacturing of human life for experimentation and
its ultimate destruction is morally reprehensible. It offends the
conscience, degrades the value of human life, and, of course, is not
medically necessary. Yet it is a practice that some in the field of
developmental biology just might be inclined to pursue if those
guidelines, if those regulations, are not out there. Why? To look at
the later stages beyond the embryo in terms of development and how
cells function, or it might be, as we have heard argued before, that
the cells have a different nature after the embryo stage but before
delivery of the fetus itself and have more stability or more
differentiation. This particular legislation preempts, it stops that
possibility.
Not only would this be a flagrant lack of respect for nascent human
life, but it would also create powerful incentives for women to undergo
an intense regimen of superovulation drugs and surgery with potentially
devastating side effects. It could exploit women, the most likely
targets of egg harvesting or fetal farming. Under no circumstances
could human fetus farming be labeled ``medical advancement.'' It is the
exact opposite, an unconscionable regression of the mores that define
our culture, a culture that upholds respect for life and health.
As a transplant surgeon, I have had that opportunity to see firsthand
how new medical discoveries and technologies can save lives and make
life more fulfilling for others. In fact, my entire professional career
was spent on these newer therapies, these newer technologies, in order
to give others a better life. But at the same time, whether it is in
the laboratory, where I spent a lot of time, or at the bedside, I have
been able to also witness how fear can also delay scientific advances
that are out there before us.
So before us today is that challenge to bridge this divide. And we
should reject an outright fear of all technological advance. We have to
work together to allow science to advance and to promote those medical
advances, whether it is in developmental biology or the human genome
project, in order to give a healthier life or more life to others. But
we have to do so. That is why we bring these bills to the floor, within
an ethical and moral framework, in this pursuit.
Even while we reject a fear of scientific and technological
advancement, we still have to--we must; it is our responsibility--live
within limits. Limits do not hamper human advances but, rather, allow
us to preserve them and to promote them. That is why we can reject this
practice of fetus farming while still embracing the hope that is
offered by stem cell research. Senators Brownback and Santorum worked
hard to bring this important legislation to the floor, and I hope my
colleagues will join me in supporting it.
The second bill, the Alternative Pluripotent Stem Cell Therapies
Enhancement Act, put forth by Senators Santorum and Specter, is a very
important bill, the purpose of which is to step back from and to remove
the ethical considerations that surround the unique potential that
these pluripotent stem cells have.
Five years ago, when I came to the floor in 2001, I said the
following:
We should not let the potential of this research drive the
moral considerations themselves. . . . We do not know what
the next great discovery is going to be 6 months from now. .
. . So the oversight process has to be responsive, has to be
ongoing. It has to recognize that science moves very quickly.
That is why we are here. We recognize that science cannot be
practiced in a vacuum. We need to promote and accelerate these medical
advances. But we also need to ensure that research practices are
channeled along lines that respect human life and dignity.
What seemed impossible even 5 years ago now seems possible. Exciting
techniques are beginning to emerge that just may make it unnecessary to
have to destroy that embryo, to disaggregate or dismember that embryo,
in order to obtain cells that have the pluripotent properties that are
either exactly like or very similar to the embryonic stem cells. And we
have talked about it a little bit earlier today, and in the past, as to
the unique property these embryonic stem cells have, which is this
pluripotentiality, which has two concepts to it: No. 1 is that they can
become any tissue--theoretically, they can become any tissue--and that
is in the differentiation; and, secondly, this overall process of self-
renewal, that they can renew and replicate themselves again and again
and again.
An adult stem cell might be reprogrammable. You might be able to
directly reprogram that cell to an earlier stage to make it more
pliable, to take it back to an earlier or closer to an embryonic phase.
Adult stem cells can be what we call multipotential, and that means
they can differentiate, and you can back them down to differentiate
into certain tissues. The embryonic stem cell is pluripotential, and
the range of tissues it can differentiate to are much greater.
But this reprogramming, coming back earlier to the adult stem cell,
earlier and earlier along its chronological development, gives the
opportunity to send that adult stem cell into various regions; thus,
this direct reprogramming concept opens up great potential. To me, and
I would hope to every Member of this body, this type of research--
research that stops short of having to destroy an embryo--to obtain
pluripotent cells through alternative ways should be supported, and I
hope can be supported, by everybody in this body.
In May of last year, 2005, the President's Council on Bioethics
issued a report bringing these alternative sources attention. At that
time, I asked and worked with several of my colleagues to put together
a piece of legislation for which we could say Federal funding will go
in that direction to derive these alternative means of developing these
pluripotential cells. With more Federal support, and with more
emphasis, these newer methods may pay off hugely in terms of scientific
advantage and clinical advantage.
They may be the way to bridge these moral and ethical differences
among people who hold wildly different and broadly different views,
which we will actually hear on the floor over the course of today and
tomorrow on stem cell research. Why? Because they avoid any destruction
of the human embryo. The alternative methods of potentially deriving
pluripotent cells, that were spelled out in the Council on Bioethics
report of May of last year, include: extraction from embryos that are
no longer living; a second proposal was blastomere extraction, which
involves a nonlethal and nonharmful extraction of the blastomeres from
embryos--and, indeed, several researchers over the course of the last
year, since that proposal was initially made, have reported success in
that regard--thirdly, extraction from artificially created organisms
that are not embryos, but embryolike--this was initially proposed by
Bill Hurlbut at Stanford and subsequently demonstrated by Dr. Rudolf
Jaenisch and others at MIT--fourthly, the direct reprogramming of adult
or somatic cells to a pluripotent state through fusion with embryonic
cell lines.
We are already driving and promoting ethical alternatives such as
[[Page S7584]]
adult stem cell research and therapies and cord cell research, both of
which have been important to date in the treatment, as well as other
types of therapy.
Today, adult stem cell research is the only type of stem cell
research that has resulted in proven treatments for human patients. At
the Multiorgan Transplant Center that I established and directed at
Vanderbilt, we did bone marrow transplants, which are commonly done for
treatment of many types of cancers now; at that point, for many types
of blood disease. We have had bone marrow transplants done in this
country for, oh, about 40 years. The first bone marrow transplant was
done in 1968.
Stem cells taken from cord blood have shown great promise in treating
the myeloproliferative disorders, the leukemias, congenital immune
system disorders.
Recently, cord blood cells have shown some ability to become natural
cells, which could lead to treatments for more heart disease and
Parkinson's disease. The first cord blood transplant was done about 20
years ago in 1988.
So every day we unlock more of the mysteries of human life, more ways
to promote and enhance our health. This compels the profound questions
we address, moral questions with which we understandably struggle.
Transplantation itself posed a question similar to those we face with
stem cell research, a little bit different in that organs were
transplanted principally, when I got started, at the end stage of life.
People without a heart would be dying 4 to 6 months later. We had to
define, as I mentioned earlier, what is brain death. We had ethical
considerations about how to allocate a very few number of organs to the
many people who waited, which literally meant some people would die
waiting for that scarce organ--all ethical considerations.
If we can devise a moral and ethical framework, then it is my belief
we will have the chance to save many lives and make many countless
other lives more fulfilling. That is why it is imperative we get our
stem cell policy right scientifically, morally, and ethically.
A lot of diseases have been mentioned on the floor, and I guess over
the next 2 days I will have the opportunity to come back and talk about
some of those particular diseases. Adult stem cells, we know, are so
powerful. They have effectively treated so many diseases today. I
mentioned bone marrow transplantation. But the list will be coming to
the floor, and they have come to the floor, about the number of
therapies with bone marrow transplantation and other adult stem cells.
Embryonic stem cells, however, do have this unique capacity of self-
replication, self-renewal over time, and greater potential to
differentiate into other types of tissues. Unlike other stem cells,
these embryonic stem cells are pluripotent, where adult stem cells tend
to be multipotent. That means the embryonic stem cells have the
capacity to become a greater range of types of tissues. They are
capable of renewing themselves and replicating themselves over and over
again indefinitely.
A number of people have brought up what the current administration
policy is. As we all know, on August 9, 2001, President Bush laid out
his principles and put in place a policy, which I supported, that for
the first time allowed Federal funding for embryonic stem cell
research. The President's policy was consistent with my initial
principles--my seventh principle: to limit the number of stem cell
lines. In order to accomplish that limiting the number of lines, the
President used a date: August 9, 2001.
The President's policy also says: Let's support stem cell lines that
have been derived from blastocysts that were going to be thrown away or
discarded. His policy is the same in that regard. The cell lines we
federally support today all came from blastocysts that were left over
by in vitro fertilization that were going to be discarded. The
President basically said it was OK to do that before August 9, but
after August 9 that will not be allowed anymore, and we will only fund
those cell lines.
I thought it was very important that Congress continue oversight.
Remember, 5 years ago or 6 years ago, I said we are going to be coming
back to this again and again and again. I think that oversight
absolutely is critical.
This third bill, the Stem Cell Research Enhancement Act, which is the
House-passed bill, the Specter-Hatch, the Castle-DeGette bill, is the
bill most people will be spending most of their time on over the next
day and a half.
Over the last 5 years--while it was widely believed when the
President put forth his policy that there would be 78 embryonic stem
cell lines available for Federal funding--we have learned, through
science, that has not been the case. In fact, of the initial
anticipated 78 lines, there are, right now, about 22 lines that are
eligible. There is some concern that these lines are becoming less and
less stable and less replicative than initially thought.
While we know that this embryonic stem cell research is at a very
early stage--remember, these embryonic stem cells were discovered,
first, just in 1998; unlike adult stem cells, where we have 40 years of
research history--we do know that the embryonic stem cell research is
moving fast and moving quickly.
The question is: Are there a sufficient number of cell lines to keep
that research going? I believe right now that the current policy unduly
restricts the number of cell lines. As I have said, I am going to be
supporting and voting for H.R. 810, the Stem Cell Research Enhancement
Act. I do not think it is an ideal piece of legislation. It has a few
essential shortcomings as written. It restricts funding to blastocysts
left over after IVF that would otherwise be discarded. And that is
consistent with my fifth principle. But the shortcomings do have to be
addressed somewhere.
First, it lacks a strong ethical and scientific oversight mechanism.
Second, the bill does not prohibit financial or other incentives
between scientists and fertility clinics. Third, the bill does not
specify whether the patients or clinic staff or anyone else has the
final say about whether an embryo will be implanted or will be
discarded.
And were circumstances different and had the House not acted so
quickly and sent the bill over--I think we should have had the
opportunity to have a thorough examination and rewrite of that bill.
However, even with those reservations, I do support the Stem Cell
Research Enhancement Act. As I said, it is completely consistent with
my principles from 5 years ago.
Many of my colleagues, such as I, have spent countless hours
grappling with this issue--the future of stem cell research. How do we
balance pro-life positions with the potential for new life and health
offered by stem cell research? There is, perhaps, an inclination to
avoid such difficult issues, to ignore them and let others debate. But
I believe and feel strongly that we must participate in defining
research surrounding the culture of life.
If we don't do that, it will define us. Finally, I thank all of my
colleagues. I know we will have a good debate over the next day. We
will have those votes at 2:45 tomorrow. I hope those votes will show
there are areas of consensus among us and that where differences exist
we can respectfully articulate and vote our conscience.
The PRESIDING OFFICER. Under the previous order, the minority is in
control of time for the next 30 minutes.
The Senator from Iowa is recognized.
Mr. HARKIN. Mr. President, I know that one of the cosponsors of the
bill, one of the great leaders in the Senate on stem cell research, has
arrived on the floor to speak. I know the Chair will be recognizing her
shortly.
I wanted, again, to just take a moment to sort of repeat for emphasis
sake what has been said before. I think the distinguished majority
leader referred to that also. It is just that here we have an instance
where so many leading scientists around, U.S. Nobel Prize winners, and
all the disease groups--I submitted a compendium of about 205, and I
think that may soar to 500 or 600 by the end of the day--are supporting
H.R. 810.
Lest one thinks that, A, either they have all been hoodwinked into
thinking this bill is something it is not or, B, that these are
malevolent people who want to just destroy embryos without any thought
about the morality or the ethics of it, they are simply mistaken. First
of all, none of these people have been hoodwinked, and most of these
scientists are as ethical
[[Page S7585]]
and moral a people as you could find anywhere. They are saying let's
use these blastocysts, embryos, or however you want to define them to
enhance life, cure disease and illness, rather than having them be
discarded, and to do it in a very ethical manner. That is what this
bill provides.
With that, I yield the floor.
The PRESIDING OFFICER. The Senator from California is recognized.
Mrs. FEINSTEIN. Mr. President, I rise to support the Stem Cell
Research Enhancement Act. Passage of this legislation will finally
allow scientists to fully pursue the promise of stem cell research. It
will offer hope to millions of our people. Mr. President, we have
waited a long time for this day. Earlier, Senator Harkin spoke to the
fact that it was in 1998 when he and Senator Specter introduced the
first bill dealing with stem cell research. I recall that year I
introduced one of the first bills dealing with ethical standards
surrounding stem cell research. So it has been 8 years.
Now, finally, the House of Representatives overwhelmingly approved
bipartisan legislation. In the intervening time, we have all heard from
patients, survivors, and scientists who are desperate to pursue this
research that one day could lead to treatments and cures for diabetes,
cancer and, yes, even spinal cord injury. Forty Nobel laureates have
weighed in with their support, as did former First Lady Nancy Reagan.
While we were waiting, we lost Christopher and Dana Reeve, tireless
advocates of stem cell research, and an inspiration for all of us.
Millions more American families experienced firsthand the devastation
wrought by catastrophic illnesses.
My colleagues and I, Senators Specter, Harkin, Kennedy, Hatch, and
Smith, worked tirelessly to bring this to a vote. We pushed privately,
we wrote letters, we gave speeches, and we held press conferences to
highlight the plight of patients who are living with illnesses day in
and day out.
Finally, after all of this pleading and delay, the Senate is acting.
I thank my colleagues for their longstanding leadership on this
issue, and I am also very grateful to the majority leader, Senator
Frist, for his support for stem cell research and his work with his
caucus to reach this agreement that has made this debate possible.
For all of the controversy that it is generating, the Castle-DeGette
Stem Cell Research Enhancement Act is remarkably simple. It reverses
the failed policy announced by President Bush in 2001 when he
restricted Federal funding to stem cell lines already in existence.
At the time, the President himself recognized the great promise of
stem cell research. He sought to find middle ground, announcing a
policy that provided Federal funding for more than 60 preexisting
genetically diverse stem cell lines. This was morally acceptable, he
said, because the life-or-death decision for these stem cell lines had
already been made.
Unfortunately, the policy did not work out as promised. These
available lines are all contaminated with mouse feeder cells and,
therefore, are useless for human research purposes. They don't have the
diverse genetic makeup that may be necessary to find cures to benefit
all Americans. Researchers cannot use them to examine rare and deadly
genetic diseases.
Castle-DeGette states that embryos to be discarded from in vitro
fertilization clinics may be used in federally funded stem cell
research no matter when they were created.
While opponents have suggested that this bill will lead us down a
slippery slope, the parameters created by the bill are actually
numerous and they are very strict:
The embryos must be left over following fertility treatment.
It must be clear that the embryos will be discarded.
The people donating the embryos must provide written consent.
These donors may not be compensated for their donation.
These restrictions mean that over 400,000 embryos could become
available, all while ensuring that researchers meet the highest of
ethical standards.
Let us be clear. We are talking about embryos that will be destroyed
whether or not this bill becomes law. It is an indisputable fact that
these embryos have no future.
We should not confuse the research permitted under this bill with the
activities described under the two other bills currently before us. I
am going to support these bills. Yet it is important to realize that
their passage will do nothing to change the status quo.
The Fetus Farming Prohibition Act bans activities that occur in
horror movies, not in our research labs. We should not allow these
farfetched and frightening techniques, which no respected scientist
anywhere endorses, to distract from the plight of millions of Americans
seeking cures from devastating diseases.
This debate is also not about the myriad research approaches
envisioned in the Alternative Pluripotent Stem Cell Therapies
Enhancement Act, as introduced by my colleagues, Senators Specter and
Santorum. This research can already be funded with Federal dollars.
Respected scientists are examining a variety of ways to create these
multipurpose cells and, of course, this work should continue.
We simply don't know which research approaches will prove fruitful
and which will fail. Alternative techniques may lead eventually to
cures for serious afflictions, or they may not. Scientists, not
Senators, should determine what research to pursue.
Supporting only the Specter-Santorum alternative is not an
endorsement of stem cell research. It is an affirmation of a policy
that is leaving American researchers far behind in one of the most
important fields of scientific discovery, and I want to spend a moment
on that.
Because of President Bush's restrictions, some of our best and
brightest scientists are leaving the United States to work overseas in
countries that have embraced the promise of comprehensive stem cell
research. This brain drain has hit my State particularly hard. Let me
give you a few examples.
Roger Peterson, a renowned scientist, left the University of
California Medical Center in San Francisco in 2001, citing the
unfriendly research climate in the United States. He is now conducting
human stem cell research at Cambridge University in the United Kingdom.
He and his UK team are exploring the biology behind pluripotent, or
multipurpose stem cells, and are looking for ways to use them for
treatment. He would not have had Federal funding to do this work in the
United States, so he left.
Dr. Judith Swain, from the University of California San Diego, will
leave for Singapore in September, where she will work at Singapore's
state-funded research institute called Biopolis. Her husband, Dr.
Edward Holmes, also of the University of California at San Diego, is a
ranking official in California's stem cell agency. He is also leaving
for Singapore.
NIH researchers, Neal Copeland and Nancy Jenkins, turned down offers
to join Stanford University's stem cell department. They, too, are
moving to Singapore. Copeland has said that he selected Singapore
because of its ``unfettered support of human embryonic stem cell
research.''
These are but a few examples of the costs of this President's policy.
Researchers are attracted by the federal funding provided in at least
10 other nations--Germany, Finland, France, Sweden, United Kingdom,
South Korea, Singapore, Israel, China, and Australia. These investments
total hundreds of millions of dollars that are already producing
tangible progress.
Sweden funds, with federal funds, 400 researchers today. South Korea
and China are each funding an additional 300. Australia has pledged $90
million through 2011. This investment has already paid off, as
Australian researchers have discovered a way to manipulate stem cells
into lung cells. This technology could one day be used to treat cystic
fibrosis.
Scientists from around the world have come to Singapore's Institute
of Bioengineering and Nanotechnology. There, they are using stem cells
to produce artificial kidneys. This could one day free people from the
burden of kidney dialysis.
Researchers in other countries now author an increasing proportion of
stem cell papers than those in the United States.
Foreign researchers have derived almost three-quarters of the world's
new
[[Page S7586]]
stem cell lines, moving quickly ahead of our country, the United
States.
Other nations have the money, the researchers, the facilities, and
the new stem cell lines they need to move forward. They are learning
more about stem cells every day and laying the foundation for
groundbreaking cures.
American scientists, on the other hand, cannot obtain Federal funding
to do this work. These Federal funding restrictions have a real world
impact on ongoing research.
American scientists are making great strides with work on mouse stem
cells. They are showing what could be possible if there is Federal
funding to extend this work into humans.
Researchers at Stanford University have recently turned cells derived
from mouse embryos into one of the building blocks of blood vessels.
This advance means they may eventually be able to grow entirely new
blood vessels, offering great promise to patients suffering from heart
disease. But without Federal funds, it is unlikely they can get the
stem cell lines to be able to do the human research.
A research team at Johns Hopkins used cells from mouse embryos to
regenerate nerves in paralyzed rats. After treatment, many of the rats
regained enough strength to walk and bear weight on their previously
paralyzed hind legs.
Mr. President, do you know what this means? This means it might--just
might--be possible to do something science said could never be done,
and that is to regenerate a severed spinal column, to regenerate the
nerves which scientists always thought never again could be
regenerated.
We would never have thought discoveries such as this were possible
even a few years ago. So think of what it means for every paraplegic or
quadriplegic to know that there is hope out there, that the first rat
tests have shown it works?
The next step is the human stem cell lines, to be able to carry out
that research on humans, and that is exactly what we are talking about
today.
Scientists now must work to translate these promising advances into
cures for humans. Such a feat will almost certainly require access to
viable lines of human stem cells, and unless we pass Castle-DeGette and
unless the President signs Castle-DeGette, these lines will not be
available in the United States to regenerate a severed spinal column,
to regenerate blood vessels, or to do anything else.
Mike Armstrong, an old friend and chairman of the Johns Hopkins board
of trustees, made this very point in a letter he wrote stating news of
this advance. Here is what he said:
Treatments not only for paralysis, but for ALS, for
multiple sclerosis, and similar diseases of the brain now
seem possible. The exact timeframe is impossible to predict,
but it will almost certainly depend on the availability of
Federal funding.
It will depend on the availability of Federal funding, and that is
what is at stake in this debate. He goes on to say:
The level of funding that will ultimately be required to
advance this field of science to human trials, however,
suggests that Federal funding will be necessary. Yet, under
current Federal policy, the only stem cell lines eligible for
Federal funding were created using mouse feeder cells and
could never be used in clinical trials with humans.
Could never be used in clinical trials for humans.
I am particularly proud of the commitment demonstrated by California
scientists and activists in the face of these restrictions. In 2004,
California voters approved a proposition, proposition 71. That
proposition created and funded the California Institute of Regenerative
Medicine. It funded it with $3 billion of taxpayers' dollars over 10
years, and it supported promising research conducted in my State. This
work will be done with careful ethical oversight. It also bans human
reproductive cloning, something we all agree is immoral and unethical.
This investment, hopefully, once it gets past the court tests, will
make California a leader in this industry and in finding cures that
will change the lives of suffering patients.
Other States are making similar investments. Connecticut, Illinois,
New Jersey, Maryland, and others are considering after 5 years of delay
because of the restriction on Federal funding--they are taking steps to
move this important work forward on a State basis. But--and here is the
but--a patchwork, State-by-State approach is no way to run science
policy. States have many other responsibilities, such as funding
education, building infrastructure, and so on, and we shouldn't expect
them to solely carry the burden of funding one of the most promising
fields of science.
There is a reason we invest so much in the National Institutes of
Health and the biomedical research they conduct. The NIH can then set
national standards and ensure that research is not being duplicated and
to see that it is carried out under ethical standards. This is
something everyone should want. You should want that Federal oversight
of NIH over all research funding that is funded with Federal dollars.
It is also important to remember that this debate is about real
people whose lives are impacted by illness every single day, day in,
day out. I have heard from so many Californians who have been
personally impacted by diseases that could one day be cured with stem
cell research. I want to tell a few of those stories.
Leslie Bishop Franco from Oakland, CA, wrote to me to say she
supports stem cell research because her mother was diagnosed with
Alzheimer's at the age of 57. Her mother quickly became unable to work
and then unable to care for herself. Leslie and her sisters and
brothers cared not only for their own young children but also for their
mother. This is something many families know all too well.
Leslie writes that even if stem cell research does not ``lead to a
cure for Alzheimer's as it has the potential in other diseases like
Parkinson's and diabetes, it will provide crucial insights into the
disease and the usefulness of new drugs.''
Mark Siegel from Los Angeles has suffered from Parkinson's for 8
years. For over half the time he has been ill, the President's policies
have slowed stem cell research. Mark was diagnosed when he was 36 years
old. One of my sons-in-law was just diagnosed, and he is 44 years old.
What happens is Parkinson's slowly erodes one's motor control. Mark
Siegel's condition had forced him to change jobs, and he is afraid we
are losing the race against time to find a cure and save his life.
Jennifer Heumann from Huntington Beach, CA, has been living with
juvenile diabetes since she was 2 years old, and she is now 16. She
says diabetes hasn't stopped her from playing varsity tennis or going
to high school dances, but she knows her disease can cause serious
complications. Without a cure, she has a 65-percent chance of dying
from heart disease or stroke and a 60-percent chance of developing
nervous system damage.
Jennifer writes:
These are the cold, hard facts, but I am not content to
admit they are my destiny. I believe that a cure is in sight,
and that embryonic stem cell research may be the key to
finding this cure. If this is the case, how can we justify
passing up this opportunity?
We all should ask that question. This impressive young woman is hard
to argue with. She makes a very eloquent point, and until we know what
kinds of research could lead to cures for these catastrophic diseases,
we should support scientists and we should push ahead every possible
lead.
These patients and family members represent only a few of the tens of
thousands of Californians I have heard from who support stem cell
research. As a matter of fact, by the latest poll, 72 percent of
Americans support stem cell research.
We don't want to spread false hope. There is still much we don't
understand about stem cells. Some of the cures may never come to
fruition, but unless we allow our scientists to continue their work, we
will never, ever know. How can any of us tell a patient suffering from
juvenile diabetes, a cancer victim, or a young man with heart disease,
that the Senate decided not to allow researchers to pursue all the
scientific leads that may one day offer them a cure? How can we say
that? How can we say we know better? How can we say because of a small
proportion of people's beliefs we are going to stop all Federal
research in the United States of America?
Last week, Karl Rove declared that the President is emphatic about
vetoing this legislation. I hope not. The President himself
acknowledged the great promise of stem cells back in 2001, and with the
health of millions of Americans at stake, it is my hope that if and
when this bill tomorrow afternoon passes the Senate and if and when
[[Page S7587]]
it goes to the President of the United States, he will reconsider his
veto threat. Too many lives depend upon the advances which may well be
possible.
Either you are for stem cell research or you are not. It is that
simple. True support for stem cells means lifting the restrictions from
hampering some of the most promising research, and only Castle-DeGette,
only H.R. 810 will do that. No matter what the President decides on
other legislation we are considering today, rejecting H.R. 810 is a
rejection of science. It is a rejection of the hopes of millions of
patients. This vote and the President's reaction to it should not be
about assuaging a small but vocal minority with views far from the
mainstream of 72 percent of the American people. Patients and their
families deserve more than the President's first veto. How would you
like it if you were President of the United States and the first veto
of your political career were a veto of the one thing that offers hope
for millions of Americans suffering from catastrophic disease? The one
thing out there.
I want to assure these patients that my colleagues and I will not
stop fighting for this. We will continue to push in every way possible.
Patients suffering from these catastrophic illnesses have already
waited too long. American scientists have already fallen behind their
international counterparts, and the time has come to finally pass
Castle-DeGette on a sweeping bipartisan basis, just as the House of
Representatives did 13 months ago.
Thank you very much. I yield the floor.
The PRESIDING OFFICER. Under the previous order, the next 30 minutes
will be controlled by the majority.
Mr. COBURN. Mr. President, Senator Brownback has graciously allowed
me to take 10 minutes of his time. I would like to do that at this
time.
First of all, I would like to set the record straight: the United
States remains the world's leader of published stem cell articles and
human embryonic stem cell articles. Specifically, it was April 6 of
this year when that statement was made. From 1998 through the end of
2005, the United States published 46 percent of all papers published
worldwide--by far the single largest proportion. The remaining 54
percent was divided among 17 other countries.
Mr. President, I ask unanimous consent to have printed in the Record
the latest peer review articles that have been brought up to date for
this year. This is about 15 pages long, and it has multiple entries.
For every disease that has been mentioned on the Senate floor by those
supporting the embryonic stem cell research, there are treatments
ongoing today using adult stem cells.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Mr. COBURN. Mr. President, the other thing I think we ought to make
sure of--and I just want to go back. The Senator from California claims
72 percent of Americans favor stem cell research. That is true. That is
true, if you ask it that way. But if you ask it: Should your tax
dollars be used to destroy embryos to then create a research mechanism,
it falls to 38 percent. So there is a difference between the ethical
dilemma. I understand people can honorably disagree on the ethical
dilemma, but we ought to be truthful about what the polling actually
says. If you specifically say what we are doing, you get a much
different answer.
I want to talk for a minute about something the majority leader
discussed. He is a transplant surgeon. There are two problems
transplant surgeons face. One is enough organs, which is a difficult
problem in our country today, but the second problem is rejection.
Nobody is talking about the long-term consequences of where we go.
Let's assume everything that everyone says about embryonic stem cell
research is right. I am highly skeptical of that, but let's assume that
it is. You still have this little problem called histocompatibility; in
other words, rejection. Whatever you do with it, you are going to have
a problem with rejection. And the thing that is so exciting about germ
cell--and I want to explain that for a minute. Germ cells--pluripotent
stem cells--just as powerful as embryonic, they can do everything that
embryonic can. They don't have that problem. No. 1, they are
pluripotent; No. 2, they continue to reproduce pluripotent cells just
like embryonic. That is new research. That is 6 months old. It was
discovered here first. It was duplicated in Germany last month. So that
is a brand new study.
The point is, you don't have rejection because you are taking your
own cells to create a pluripotent cell, and that is the wonderful thing
about adult stem cells, about cord blood stem cells, about germ cells,
is that they create a pluripotent cell. There is no rejection. So when
you hear all the talk about embryonic stem cell research, the thing to
remember is when you get the treatment, you are going to have the side
effects like everybody else who has the transplant--if it works--and
that is immune-suppressive drugs. You are going to have to have them.
The only way not to have that is to do fetal farming or human cloning,
where you clone yourself and then take part of what you have cloned
back, which we already know is illegal and is banned. So it is
important for the debate to focus on that.
Everybody in this country wants cures. Everybody wants to do the
thing that will get us there the fastest with the least complications,
and we want to invest our dollars in what will be most successful.
One of the things my dad taught me is to look around the world, and
if you want to see what is happening, follow the money. If you look
around the world today, the world as a whole, and you look at where the
money is being spent, it is not being spent on embryonic stem cells. It
is being spent on stem cells from us, just like we had the debate a
moment ago. We now know ductal cells from somebody's pancreas can
create new insulin-producing cells. We know now the mucosa, the lining
of your mouth, can create cells to make you a new cornea. You don't
have to have a cornea transplant in the future because your own cells
are going to be able to create a new cornea. We also know that we have
stem cells in our body that can take away cystoid macular edema, this
aging process where we as seniors start to lose our vision--the
cloudiness--the macular area of the retina starts to fall away. All of
these wonderful things that we are doing versus nothing that has been
accomplished.
I also would refer to the reference of the Senator from California to
the renal success. It wasn't done with an embryonic stem cell, it was
done with an adult stem cell. That research was all adult stem cells.
So we end up tending to confuse what has really happened.
The fact is, all the success in treatment, all the success in terms
of who is willing to invest private capital, where they are putting it,
they are not putting it in embryonic. There is a reason for it. It is
because in the long term it won't be the best treatment. It is fun
science. As a doctor, I will tell you there could be no more fun or
rewarding or interesting science than embryonic stem cell because you
can turn things on and turn things off. There is no question about it.
But what we are finding out is you can actually do that with our own
cells, our own stem cells.
This idea of de-differentiation--and I want to explain that for a
minute because we are going to hear a lot about it in the next 10
years--we take one of your stem cells, one of your multipotent--not
totipotent, not pluri potent, but multi--and reverse its mechanism
where we make it pluripotent. We are doing that in several stem cells
now with an enzyme called reversa, where they are reversing the cell
structure and making it revert back to what it was; in other words,
grow in reverse to become pluripotent.
So I hope everybody will remember, this isn't a choice about cures or
no cures. We are getting cures like crazy right now with adult stem
cells and cord blood. We are going to be doing tons more when this germ
cell comes forward. There is no question the scientific community is
extremely excited about germ cell pluripotent stem cells because it has
all the potential that an embryonic stem cell has and none of the
problems.
With that, I yield back my remaining time, and I thank the Senator
from Kansas.
[[Page S7588]]
Exhibit 1
PEER-REVIEWED REFERENCES SHOWING APPLICATIONS OF ADULT STEM CELLS THAT
PRODUCE THERAPEUTIC BENEFIT OR HUMAN PATIENTS (NOT A COMPLETE LISTING,
SAMPLE REFERENCES)
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; Oct. 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
transplantion'', Lancet 365, 193-1941 ,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 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, Bone Marrow Transplantation 37, 1003-1008, 2006
Angioimmunoblastic lymphadenopaihy 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 at., 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 at.; ``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 post-
transplantation 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 Advance
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 at., 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 autoogous
hematopoietic stem-cell transplantation for advanced soft
tissue sarcoma in adults''; J. Chin. Oncol. 18, 3643-3650;
Nov 1 2000
[[Page S7589]]
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 haemato1ogical 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
Anagnostopoulos A et al.; ``High-dose chemotherapy followed
by stem cell transplantation in patients with resistant
Waldenstrom's macroglobulinemi''; 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 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 transp1antation in
adults: results of the prospective Cord Blood Transplantation
(COBLT), Biol Blood Marrow Transplant 11, 149-160, February
2005
Cervantes F, Modem 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 P et al., [Complete regression of bone marrow
fibrosis following allogeneic peripheral blood stem cell
transplantation in a patient with idopathic 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
Wulfffraat, 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., Haematopoietic 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 hematopoietic 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 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 ce11
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 al., 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; ``Hematopoietic 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
[[Page S7590]]
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 Trat. 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 autologbus
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 or 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)-Xl 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 system 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. Pysician 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 l13, 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, 209-12, 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 al., Successful engraftment without radiation
after fludarabine-based regimen in Fanconi anemia patients
undergoing genotypically identical donor hematopoietic cell
transplantation, Pediatr Blood Cancer, 46, 630-636, May
1,2006
Kohli-Kumar Met 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
Chronic Epstein-Barr infection
Fujii N et al.; ``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/Replacment 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 Aug 2004
OCULAR
Corneal regeneration
Inatomi T et al., ``Midterm results on ocular suface
reconnstruction 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 Sept 2004
Anderson DF et al.; ``Amniotic Membrane Transplantation
After the Primary Surgical Management of Band Keratopathy'';
Cornea 20(4), 354-361; May 2001
[[Page S7591]]
Anderson DF et al.; ``Amniotic membrane transplantation for
partiallimbal 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'';
Opthalmology 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 angiogeneis for
patients with limb ischaemia by autologous transplantation of
bone-marrow cells: a pilt 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 of 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, 097-3106, 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 CD133-
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 Lance 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]Fluorodeoxyglucos 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 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 (pubished 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
Mr. BROWNBACK. Mr. President, I want to thank my colleague from
Oklahoma. He is learned. He has spent the time to study these issues as
a doctor. He has worked on these issues and he cares a great deal about
them, and I appreciate his time and his focus on this issue.
I want to discuss a few additional things in response to the comments
that have been made thus far. I want to get back to what we are talking
about. We are talking about destroying young human life for research
purposes. I will show a picture of that so people will get the idea--
and I know people do--but it is important to remember we all started
out looking like this. Even the Presiding Officer, as handsome as he
is, looked like this at one point in time. Just a clump of cells--that
was him.
This is a particular young person by the name of Hannah with whom I
just met a few hours ago. This is when she was adopted as a frozen
embryo, and this shows her development taking place. If you destroy her
here, we don't get her here. That is the key. She was called a
snowflake: an adopted frozen embryo.
I hope some people who are maybe watching or hear about this, if they
have frozen human embryos, they consider putting them up for adoption
because a number of people want to adopt them.
A couple of people adopted Hannah. They had fertility problems
themselves, could not conceive. They used IVF, and so adopted her as a
snowflake, as a frozen embryo. She was implanted, and now we have
Hannah. Hannah is quite--I guess you would say out of the mouths of
babes, children, comes great wisdom.
This is a chart she did last year when she was in Washington. When
the House was considering legislation--this same legislation--she did
this chart, this letter that kids write, my kids write--I love them.
She said--this is
[[Page S7592]]
Hannah--snowflake: We're kids, I love you. Then she draws three
pictures here below. This is her smiling because she got adopted, and
she is here. Here is another frozen embryo--these are embryos--that is
sad because he is still sitting in a frozen state, and then here is one
that, as she explains, is saying: What, are you going to kill me? This
was her explanation to her mother who just gave this chart to me.
I hope people really would think about that. This is not just a clump
of tissue. This is not just a group of a few cells. This is not a hair
follicle. This is not a fingernail. This is Hannah. And, if nurtured,
she grows to be just this beautiful child. We have a lot of them,
frozen embryos, and I hope people will consider putting them up for
adoption because there are a lot of people who want to adopt them.
My colleagues talked about cures. I want cures. I have talked a lot
about cures here on the floor. I have talked about it for a lot of
years. There are 72 clinical human trials using adult cord research. If
we want the people Senator Feinstein and others talked about to get
cures now, the certain way to do this is to not fund embryonic stem
cell research. The people she is talking about are not going to be
cured any time soon.
I want to read some quotes from scientists talking about cures from
embryonic stem cell research. I want to lay my hands on this real quick
so that people can hear what the scientists are saying about this
particular area. Let me get to that in a second, as soon as we can pull
that out from the notebook.
I want to hit a second point on this and then print this for the
Record. Mr. President, I will ask unanimous consent that this be
printed in the Record at the end of my statement.
Mr. President, this is a series of one-page--a cover article on stem
cells, embryonic stem cells forming tumors. We have talked about this
being a problem. This has been a problem on fetal tissue research,
about 15 years ago. This stack is of the front pages of peer-reviewed
articles citing embryonic stem cells creating tumors when implanted in
other animals. Let me just read a few of these summations. This is just
the front cover, and people can look up the whole article if they want.
More than 70 percent of the mice that received embryonic stem cells
derived neuro processors--or precursor cells developed teratomas, 70
percent teratomas, tumors. That was a 2006 article.
Rats grafted with embryonic stem cells de-differentiated in vitro for
16 days developed severe teratomas--tumors. This is an article for
publication, March of 2006. I am just reading the front page of these.
Here is another article, a 2005 article. We conclude that pluripotent
cell types used in this study are unsuitable for achieving safe
engraftment in a Guinea pig brain. Why? Creation of teratomas--tumors.
Unlimited self-renewal and high differentiated potential poses the
risk of tumor induction after engraftment. This is just the front page
of another article, December of 2004.
Here is another article. Conclusions: the cells will, however, form a
tumor if they leak into an improper space such as the thoracic cavity.
This is an article from 2003.
Then I have three more articles. These are just summations of peer-
reviewed articles. They form tumors. That is the problem with embryonic
stem cells.
So the Senators from California, Michigan, Iowa, and Pennsylvania and
other places saying we want cures--I want cures. The research is saying
embryonic stem cells form tumors. You put them into individuals, they
form tumors. And while we hope at some point in time something positive
happens, the problem is, they form tumors. This isn't working. So if we
want treatments and cures, the answer isn't embryonic stem cells, it is
adult stem cells, cord blood, where we don't have a tumor formation
problem and where we are getting all of these initial successes that
are taking place
We are also going to consider legislation--and I will come back to
another point here--we are going to consider legislation on fetus
farming. There are three bills that are up and one of the bills is to
ban fetal farming--fetus farming. I want to speak on that bill. I am a
cosponsor of the bill. It would prohibit a gruesome procedure known as
fetus farming. I am hopeful this passes with broad bipartisan support.
What this prevents is growing young humans to a certain stage, then
harvesting their parts like an organ donor--parts. You grow a cloned
human to a certain stage, let the cells differentiate and then harvest
the parts. The Fetus Farming Prohibition Act is intended to prevent the
exploitation of women for the purpose of harvesting spare organs,
bodies parts, and tissue. In an ideal world we wouldn't need this type
of legislation, yet we have already seen four scientific papers
published on proof of concept of where they clone an animal to harvest
the tissue to put into another animal to see if there was a rejection
issue. Such proof of concept or proof of principle is simply the first
case you take before actually moving to doing it in humans. That is why
we seek to ban this particular procedure.
Some of my colleagues are saying of course nobody would think about
doing this. I remember at the outset of this debate 8 years ago,
everybody said of course we are not going to clone human beings. That
is not necessary; that is abhorrent, and we wouldn't do that. The same
people who were saying that are now saying it is essential we clone
human beings, so the distance from ``of course we would never'' to ``of
course we must'' seems to only take a matter of years and that is why
we are seeking to ban this particular area of using human beings. Human
beings, as I said at the outset, are ends in themselves. They should
not be used for somebody else's purposes. It is beneath human dignity
to turn humans into commodities--that is organ factories--and that
would be the case with fetus farming. That is what this act does; it
prohibits it. I am hopeful my colleagues can strongly support this ban
on fetal farming that is going to come before this body and I hope will
pass the House and be sent to the President for signature.
I want to talk about an area that perhaps we all pretty easily fall
into. That is, we get contacted by individuals who have a particular
malady or disease or genetic problem and we tell them we want to give
them a cure.
We do want to give them a cure. Everyone in this body wants to give
them a cure. But then false hope can be held out or people can start
down a road that doesn't produce. That is where we have been going.
That is where we are going with the embryonic stem cells. This is a
route into which we put half a billion Federal taxpayer dollars and it
hasn't produced. It is time to move somewhere else. We have tried this
route before.
I want to quote one of my colleagues on fetal tissue research. Some
of my colleagues remember 10 or 15 years ago we were debating fetal
tissue research. The promises sound strangely familiar, what people
said.
There is substantial evidence that fetal tissue research
will offer a new hope of prolonged life, greater quality of
life, and perhaps one day even a cure for many of these
diseases at a tremendous economic and social cost-saving to
the country.
Then people frequently would list different areas that would be
covered, such as Alzheimer's and Parkinson's disease and the like.
We funded fetal tissue research. The reason I mentioned this is it is
quite a bit like fetal farming. In fetal tissue research the fetus is
aborted and then body parts harvested for use in somebody else, and
that was going to cure everybody. We were going to get rid of
Alzheimer's and Parkinson's and Lou Gehrig's and cancer and all these
areas with great promise. Yet we saw what happened on the fetal tissue
research.
Parkinson's research is set back by failure of fetal cell
grants--disastrous side effect--absolutely devastating--it
was tragic, catastrophic, it's a real nightmare. And we can't
selectively turn it off.
That was what the researchers said when they took fetal tissue and
put it in somebody to deal with Parkinson's disease. What we are trying
to prohibit with the Fetal Farming Act is this from backing up even
further, or doing it in a clone state, and inserting cancerous tumors
into individuals. You can't selectively turn it off. That is why we
want to ban this. That is why it is the wrong thing to do. It was the
wrong thing to do then, using fetal tissue in that particular case.
It is also the wrong thing to promise people these cures when we look
at the
[[Page S7593]]
science of this and you know pretty likely this is not going to work--
from all the scientific evidence. Let me read from some of the eminent
scientists. By the way, the material I had printed for the Record on
tumor formation, I believe every one of these scientists, at least most
of the scientists published in these articles, are pro embryonic stem
cell research. They support embryonic stem cell research. They want it
to work. The problem is, tumor formation, just as we saw with fetal
tissue research. The cell grows fast, undifferentiated, but it can get
in the brain and in some cases formed fingernails or hair follicles
instead of brain tissue.
What are some of the scientists who are strong embryonic stem cell
supporters saying about the likelihood of human treatments using
embryonic stem cells? Here I am quoting from people who support this
research. Lord Winston, a British stem cell expert, has warned his
colleagues over the political hype in support of human embryonic stem
cells:
One of the problems is that in order to persuade the public
that we must do this work, we often go rather too far in
promising what we might achieve. This is a real issue for the
scientists. am not entirely convinced that embryonic stem
cells will, in my lifetime, and possibly anybody's
lifetime for that matter, be holding quite the promise
that we desperately hope they will.
This was in a lecture he gave in 2005. If we want to cure people, as
different colleagues are talking about and giving different human
examples, people examples--this is a clear route here, adult and cord
blood. Put the money there if we want to cure people. If we want to do
the scientific research, that is another thing, but if we want to cure
people, we have an answer and it has no ethical problem to it. But we
should not overhype the embryonic stem cells when the lead scientist
say he thinks it is unlikely any time soon, if ever, to work, as I just
quoted to you there.
Let me give another quote from the journal ``Science.'' It carried a
piece last summer in which supporters of embryonic--destructive human
embryonic stem cell research admitted:
It is necessary that prospective donors of human eggs
recognize the large gap between research and therapy. This is
particularly important in frontier areas of research where
therapeutic impact in humans is unproven.
Also, it is nearly certain that the clinical benefits of
the research are years or maybe decades away. This is a
message that desperate families and patients will not want to
hear.
If we are talking cures, we have an answer here. But it is not
embryonic stem cell research. Otherwise we should not be talking about
cures. We should be talking maybe about research on embryos, research
on embryonic stem cells. We are interested in how they work, but we
should not be talking cures because the cures are coming in the adult
and cord blood route.
I will have the ``Science'' article printed. I ask unanimous consent
all these be printed in the Record at the end of my presentation.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Mr. BROWNBACK. This is an op-ed piece in the Washington Post. David
Shaywitz put it in, in 2005.
While stem cell advocates have helped voters connect stem
cell research with compelling images of patients who might
one day benefit from treatments, such therapies are unlikely
to emerge soon enough to benefit most current proponents. . .
.
. . . scientists must do a better job of articulating the
limitations of our existing knowledge, taking care to
emphasize not only the ultimate therapeutic potential of
these cells, but also how far we are from achieving such
therapies.
That is from scientists who support embryonic stem cell research.
Let's be clear what we are talking about in this particular field.
Now I want to talk about the pluripotent nature of adult stem cells.
Here, Dr. Coburn, Dr. Frist, and others would be better qualified,
obviously, than I could ever dream of being about this topic, but this
has been raised for some period of time. The theory has gone, embryonic
stem cells are pluripotent, they can form any type of cells. Adult stem
cells cannot. Their plasticity is insufficient for them to be able to
form other types of cells.
I simply point to this chart, listing 16 peer-reviewed studies
showing alternative sources of pluripotent stem cells other than
embryonic stem cells, and almost all of these are out of adult stem
cells--pluripotency.
I urge my colleagues, the science has moved quite rapidly on this. I
hope we can get up to speed with where the science is on this. There is
pluripotency in other stem cells. There is pluripotency in cells other
than the embryonic stem cells. We have the alternative bill, the
Santorum-Specter bill, looking at other alternative sources of
embryonic-type like stem cells that you do not have to destroy an
embryo to get to. Look at those fields and those areas, these adult
stem cells and this research, rather than saying the only source is
embryonic, because it is not. That is not the only source because the
science continues to move on through this and find other areas of
pluripotency in adult stem cells as they are created.
Because I have a little bit of time--I ask the Chair, how much time
is remaining?
The PRESIDING OFFICER. The Senator has 4\1/2\ minutes.
Mr. BROWNBACK. Fantastic. I have a picture I want to show, then,
because this is a real hope. It is also a bit of a tragedy. Here is a
gentleman I hosted at a hearing about Parkinson's disease. He suffers
from Parkinson's disease. He had an adult stem cell treatment. We got
him in to testify. It is adult stem cells put back in his own part of
the brain, it is his own cells, so there is not a rejection problem. He
was Parkinson's free for 5 years. We had trouble getting him in to
testify. He was out doing African safaris and things. We couldn't get
him to come in.
I say that because that is the beauty of it. The tragedy of it is
some of the Parkinson's traits are coming back. He would love to have
another treatment for Parkinson's with his own adult stem cells. Yet we
have so few clinical trials going on, we are so short in the funding of
this, that he is not able to get additional treatments or other
Parkinson's patients aren't able to get this.
I ask my colleagues, if we want to treat, let's take the half a
billion dollars and let's put it into research for a guy such as this,
where we have a real promising start. He was Parkinson's free of things
here for 5 years, and then it started coming back.
My final comment I have in the time I have left is: What a beautiful
time. What an opportunity we have for people to live longer and better
lives. This is a glorious time for us to make a step forward.
Senator Feinstein from California and I cochair the cancer caucus. We
are setting an objective of ending deaths by cancer in 10 years. It is
going to have to be aggressive to be able to do this. We are going to
have to do some work on these adult and cord blood stem cell areas.
What a beautiful time. Let's invest wisely. Let's not check our morals
at the door--our values. Let's treat every single human as a sacred,
beautiful child of the living God and we are going to be here 10 years
from now with amazing stories of things that have happened, and a happy
heart, and a clear conscience at the same time--that we did it, we did
it the right way, that more people are alive today, not dead, we didn't
sacrifice other human beings in the process, and people are cured.
People with spinal cord injuries are walking. People with Parkinson's
no longer have it.
We have people in whom this is taking place today. We didn't give
them cancer in the process of trying to cure them--where we are having
the troubles with the embryonic stem cells.
This can happen if we will go the right way, ban the fetal farming,
not expand and use taxpayer dollars to fund destructive human embryonic
research where you destroy a human, and look at these alternatives. It
can and it will happen. And that--that is going to be a beautiful day.
I believe my time has expired and I yield the floor
Exhibit 1
Stem-Cell Reality: ``ESC Treatments Decades Away''
``Similarly, it is important not to use the term `therapy'
when what is meant is `research' and not to refer to human
embryonic stem cell research as `therapeutic cloning.' There
is currently no such thing as `therapeutic cloning' and this
is not `therapeutic cloning research,' nor can we say with
any certainty that ``cell therapy'' is in the near future.''
(Source: Magnus & Cho, ``Issues in Oocyte Donation for Stem
Cell Research,'' Science Vol. 308, 1747-1748, June 17, 2005.)
[[Page S7594]]
Last summer, the prestigious journal Science carried a
piece, in which supporters of destructive human embryonic
stem cell research admit:
``It is necessary that prospective donors [of human eggs]
recognize the large gap between research and therapy. This is
particularly important in frontier areas of research where
therapeutic impact in humans is unproven.
``Also, it is nearly certain that the clinical benefits of
the research are years or maybe decades away. This is a
message that desperate families and patients will not want to
hear.
Stem-Cell Reality: Over-Hyped ESC's
British Stem Cell Expert Lord Winston
Lord Winston, a British stem cell expert, has warned his
colleague over the political hype in support of human
embryonic stem cells:
``One of the problems is that in order to persuade the
public that we must do this work, we often go rather too far
in promising what we might achieve.
This is a real issue for the scientists. I am not entirely
convinced that embryonic stem cells will, in my lifetime, and
possibly anybody's lifetime for that matter, be holding quite
the promise that we desperately hope they will.''
(Source: ``Should We Trust the Scientists?'' Gresham
College Lecture, June 20, 2005)
Stem-Cell Reality: ``ESC Therapies Unlikely Soon''
Harvard stem cell researcher--and proponent of destructive
human embryonic stem cell research--David Shaywitz writes in
an op-ed carried by the Washington Post:
``While stem cell advocates have helped voters connect
embryonic stem cell research with compelling images of
patients who might one day benefit from treatment, such
therapies are unlikely to emerge soon enough to benefit most
current proponents . . .
``. . . scientists must do a better job of articulating the
limitations of our existing knowledge, taking care to
emphasize not only the ultimate therapeutic potential of
these cells, but also how far we are from achieving such
therapies.''
(Source: David Shaywitz, ``Stem Cell Reality,'' The
Washington Post, April 29, 2005.)
____
[From the New York Times, Mar. 8, 2001]
Parkinson's Research Is Set Back by Failure of Fetal Cell Implants
(By Gina Kolata)
A carefully controlled study that tried to treat
Parkinson's disease by implanting cells from aborted fetuses
into patients' brains not only failed to show an overall
benefit but also revealed a disastrous side effect,
scientists report.
In about 15 percent of patients, the cells apparently grew
too well, churning out so much of a chemical that controls
movement that the patients writhed and jerked uncontrollably.
The researchers say that while some patients have similar
effects from taking too high a dose of their Parkinson's
drug, in this case the drugs did not cause the symptoms and
there is no way to remove or deactivate the transplanted
cells.
On the researchers' advice, six patients who enrolled in
the study but who had not yet had the implantation operation
have decided to forgo it.
The results, reported today in The New England Journal of
Medicine, are a severe blow to what has been considered a
highly promising avenue of research for treating Parkinson's
disease, Alzheimer's disease and other neurological ailments.
The study indicates that the simple solution of injecting
fetal cells into a patient's brain may not be enough to treat
complex diseases involving nerve cells and connections that
are poorly understood. Some say it is time to go back to the
laboratory and to animals before doing any more operations on
humans.
The findings may also fuel the debate over whether it is
appropriate to use tissue from aborted fetuses to treat
diseases. Despite their disappointment, some researchers said
they hoped that the results would not bring fetal cell
research to an abrupt halt. The research has been
controversial because the fetal cells were obtained from
abortion clinics.
``This is still our one great hope for a cure,'' said Dr.
J. William Langston, who is scientific director and chief
executive officer at The Parkinson's Institute in Sunnyvale,
Calif.
Parkinson's disease occurs when cells of the substantia
nigra region in the base of the brain die, for unknown
reasons. The hope was that fetal substantia nigra cells might
take over for them. But, the study showed, in older patients
the operation had no benefit and in some younger patients,
the transplants brought on nightmarish side effects.
Although the paper depicts the patients with the side
effects in impassive clinical terms, doctors who have seen
them paint a very different picture.
Dr. Paul E. Greene, a neurologist at the Columbia
University College of Physicians and Surgeons and a
researcher in the study, said the uncontrollable movements
some patients suffered were ``absolutely devastating.''
``They chew constantly, their fingers go up and down, their
wrists flex and distend,'' Dr. Greene said. And the patients
writhe and twist, jerk their heads, fling their arms about.
``It was tragic, catastrophic,'' he said. ``It's a real
nightmare. And we can't selectively turn it off.''
One man was so badly affected that he could no longer eat
and had to use a feeding tube, Dr. Greene said. In another,
the condition came and went unpredictably throughout the day,
and when it occurred, the man's speech was unintelligible.
For now, Dr. Greene said, his position is clear: ``No more
fetal transplants. We are absolutely and adamantly convinced
that this should be considered for research only. And whether
it should be research in people is an open question.''
Dr. Gerald D. Fischbach, who was director of the National
Institute of Neurological Disorders and Stroke, which
sponsored the study, said that while the operation had been
promoted by some neurosurgeons as miraculous, this was the
first time it was rigorously evaluated. It used sham surgery
as a comparison, a controversial and rarely used strategy but
one that researchers felt was necessary to understand the
true effects of the operation.
Dr. Fischbach, who is now dean of the faculty of medicine
at the Columbia University College of Physicians and
Surgeons, was the director of the institute only at the end
of the study.
``Ad hoc reports of spectacular results can always occur,''
Dr. Fischbach said. ``But if you do these studies
systematically, this is the result you get.''
The surgery, he added, ``is not the final solution that
people would have hoped going into it.''
In the study, researchers, led by Dr. Curt R. Reed of the
University of Colorado Health Sciences Center in Denver and
Dr. Stanley Fahn of the Columbia University College of
Physicians and Surgeons, recruited 40 patients, ages 34 to
75, who had had Parkinson's disease for an average of 14
years. The patients were randomly assigned to have substantia
nigra cells from four fetuses implanted in their brains or to
have sham surgery, for comparison.
The surgery took place in Colorado and the patients were
evaluated in New York. The fetal cell surgery involved
drilling four small holes in the patient's forehead and then
inserting long needles through the holes into the brain and
injecting fetal cells. The sham surgery involved drilling the
holes but not injecting needles into the brain. After a year,
the patients were told whether they had the fetal cell
surgery and, if not, they were offered it if they wanted it.
The study's primary measure of success was whether the
patients themselves noticed that they were better, as
determined by a survey that they mailed in a year later but
before they knew whether they had had fetal cell implants or
a sham operation. The study found no difference between the
two groups--neither those who had had the fetal cell
operation nor those who had had the sham surgery notice an
improvement in their symptoms.
Other tests, like neurologists' assessments of the patients
while they were taking their medication and the patients'
assessments of their condition in diaries they kept also
showed no effect of the surgery. And there was no difference
between the two groups in the doses of drugs needed to
control the disease.
The one glimmer of hope came from assessments by
neurologists before the patients had had their first dose of
medication in the morning. By that measure, the 10 patients
under age 60 who had had the fetal cell implants seemed
better than those who had had sham surgery, with less
rigidity, although their tremor was just as bad.
Dr. Freed hailed that result, saying, ``It was clear-cut
improvement.''
And, he added, the fetal cells survived in most patients'
brains.
``I would be disappointed if people used a strict clinical
trial approach,'' Dr. Freed said. ``This study is about
multiple phenomena.''
Others were less enthusiastic, pointing out that finding
subgroups after the fact who may have benefited suggests a
hypothesis for future studies, not evidence of an effect.
``We try to teach everybody that you have to identify
beforehand what's the primary outcome,'' said Dr. William
Weiner, the director of the Maryland Parkinson's Disease and
Movement Disorder Center and a professor of neurology at the
University of Maryland School of Medicine in Baltimore,
referring to the measure of success determined before the
study began. ``In this case, they picked a subjective
assessment by the patients themselves, which I think is a
very good one.''
And so, Dr. Weiner said, when the patients noticed no
improvement, ``the study was negative.''
In addition, Dr. Langston said, even if a Subsequent study
confirmed that the surgery had an effect on the condition in
younger patients before they took their medicine in the
morning, and even if there was a way of preventing the
terrible side effect, the operation would still hardly be a
breakthrough. Parkinson's disease is almost always a disease
of the elderly, he noted, adding that well under 10 percent
of patients who would be candidates for the surgery are
younger than 60.
The wiggling and writhing movements first emerged a year
after the operation, showing up in five of the younger
patients who had at first appeared to benefit from fetal cell
surgery--three who had the operation in the initial phase of
the study and two who had it a
[[Page S7595]]
year later, when they learned that they had originalIy had a
sham surgery. While doctors sometimes see such effects in
Parkinson's patients, it is caused by giving too much of
drugs that act like dopamine in the brain. And it can be
controlled by reducing the drugs.
In this case, however, drugs were not the culprit. Even
when doctors took away the drugs, the symptoms persisted.
The fetal implant study had been controversial from the
start, both because it included sham surgery and because it
used fetal tissue from abortions. But many Parkinson's
disease experts said it had to be done because doctors were
already offering the surgery to patients, and charging them
for it, at costs of $40,000 or more, with no evidence that
they were helping them. Yet patients, facing a disease in
which brain cells slowly and inexorably die and in which even
the drugs that once controlled their symptoms of tremor and
rigidity would inevitably fail, took their chances with the
operation, thinking they had little to lose.
Dr. Freed said he was the first in the United States to
offer the treatment, starting in 1988 with a 52-year-old man,
who is still alive although, of course, he also still has
Parkinson's disease.
Dr. Freed continued to offer it to paying patients while he
was treating those who were part of the federal study and
whose procedures were paid for by the study. He said he
considered these other operations research because he
experimented with different amounts and placements of fetal
cells. He has given fetal cell implants to 27 patients, he
said, with the most recent operation last October.
Dr. Freed said his group was now implanting less fetal
tissue and putting the tissue in a different area of the
brain, hoping to avoid the devastating side effects. But, he
said it would be a mistake to stop doing the surgery
altogether.
``To say that you can't do or shouldn't do human research
because the research has uncertain outcome, I think would be
a bad decision,'' Dr. Freed said.
Meanwhile, a second federally financed study of the
operation is winding to a close, and some researchers say it
is time to go back to animal studies and learn more about the
complex roles of the brain cells involved in Parkinson's
disease.
Dr. Weiner said that if a patient came to him today seeking
advice, he would say: ``The bottom line for patients is that
human fetal cell transplants are not currently the best way
to go. If you are willing to pay for them, you can still have
them done. But my advice is you ought not to do this.''
____
[From Stem Cells Express,
Feb. 2, 2006]
Embryonic Stem Cell-Derived Neuronally Committed Precursor Cells with
Reduced Teratoma Formation After Transplantation into the Lesioned
Adult Mouse Brain
(By Marcel Dihne)
ABSTRACT
The therapeutic potential of embryonic stem (ES) cells in
neurodegenerative disorders has been widely recognized, and
methods are being developed to optimize culture conditions
for enriching the cells of interest and to improve graft
stability and safety after transplantation. Whereas teratoma
formation rarely occurs in xenogeneic transplantation
paradigms of ES cell-derived neural progeny, more than 70% of
mice that received murine ES cell-derived neural precursor
cells develop teratomas, thus posing a major safety problem
for allogeneic and syngeneic transplantation paradigms. Here
we introduce a new differentiation protocol based on the
generation of substrate-adherent ES cell-derived neural
aggregates (SENAs) that consist predominantly of neuronally
committed precursor cells. Purified SENAs that were
differentiated into immature but postmitotic neurons did not
form tumors up to four months after syngeneic transplantation
into the acutely degenerated striatum and showed robust
survival.
____
[From Stem Cells Express, Mar. 23, 2006]
Transplantation of Human Embryonic Stem Cell-Derived Cells to a Rat
Model of Parkinson's Disease: Effect of In Vitro Differentiation on
Graft Survival and Teratoma Formation
(By Anke Brederlau)
Abstract
Human embryonic stem cells (hESCs) have been proposed as a
source of dopamine (DA) neurons for transplantation in
Parkinson's disease (PD). We have investigated the effect of
in vitro predifferentiation on in vivo survival and
differentiation of hESCs implanted into the 6-OHDA (6-
hydroxydopamine)-lesion rat model of PD. The hESCs were
cocultured with PA6 cells for 16, 20, or 23 days, leading to
the in vitro differentiation into DA neurons. Grafted hESC-
derived cells survived well and expressed neuronal markers.
However, very few exhibited a DA neuron phenotype. Reversal
of lesion-induced motor deficits was not observed. Rats
grafted with hESCs preadifferentiated in vitro for 16 days
developed severe teratomas, whereas most rats grafted with
hESCs predifferentiated for 20 and 23 days remained healthy
until the end of the experiment. This indicates that
prolonged in vitro differentiation of hESCDs is essential for
preventing formation of teratomas.
____
[From Neuroscience Research, 2005]
Survival and engraftment of Mouse Embryonic Stem Cell-Derived Implants
in the Guinea Pig Brain
(By A.J. Robinson)
Abstract
a-Mannosidosis is a lysosomal storage disease resulting
from a deficiency of the enzyme a-d-mannosidase. A major
feature of a-mannosidosis is progressive neurological
decline, for which there is no safe and effective treatment
available. We have a guinea pig model of a-mannosidosis that
models the human condition. This study investigates the
feasibility of implanting differentiated mouse embryonic stem
cells in the neonatal guinea pig brain in order to provide a
source of a-mannosidase to the affected central nervous
system.
Cells implanted at a low dose (1.5 10 \3\ cells per
hemisphere) at 1 week of age were found to survive in very
low numbers in some immunosuppressed animals out to 8 weeks.
Four weeks post-implantation, cells implanted in high numbers
(10 \5\ cells per hemisphere) formed teratomas in the
majority of the animals implanted. Although implanted cells
were found to migrate extensively within the brain and
differentiate into mature cells of neural (and other)
lineages, the safety issue related to uncontrolled cell
proliferation precluded the use of this cell type for longer-
term implantation studies. We conclude that the pluripotent
cell type used in this study is unsuitable for achieving safe
engraftment in the guinea pig brain.
____
[From Investigative Ophthalmology & Visual Science, Dec. 2004]
Neurally Selected Embryonic Stem Cells Induce Tumor Formation After
Long-Term Survival Following Engraftment Into the Subretinal Space
(By Stefan Arnbold, Helmut Klein, Irina Semkova, Klaus Addicks, and
Ulrich Schraermeyer)
Purpose. To determine whether transplantation of embryonic
stem (ES) cells into the subretinal space of rhodopsin-
knockout mice has a tumorigenic effect.
Methods. Mouse ES-cell-derived neural precursor cells
carrying the sequence for the green fluorescent protein (GFP)
gene were grafted subretinally into the eyes of
rhodopsin-/- mice, whereas control animals
underwent sham surgery. Eyes were retrieved after 2, 4, and 8
weeks after cell injection or sham surgery for histologic
analysis.
Results. Gross morphologic, histologic, and
immunohistochemical analysis of eyes at 2 and 4 weeks after
engraftment exhibited no morphologic alterations, whereas
neoplasia formation was detected in 50% of the eyes evaluated
at 8 weeks after engraftment. Because the neoplasias
expressed differentiation characteristics of the different
germ layers, they were considered to be teratomas. The
resultant tumor formation affected almost all layers of the
eye, including the retina, the vitreous, and the choroid.
Conclusions. Although ES cells may provide treatment for
degenerative disease in the future, their unlimited self-
renewal and high differentiation potential poses the risk of
tumor induction after engraftment. Thus, more care must be
taken before using ES cell transportation as a therapeutic
option for patients with degenerative disease.
____
[From Transplantations, Oct. 15, 2003]
Engraftment and Tumor Formation After Allogeneic In Utero
Transplantation of Primate Embryonic Stem Cells
(By Takayuki Asano)
Background. To achieve human embryonic stem (ES) cell-based
transplantation therapies, allogeneic transplantation models
of nonhuman primates would be useful. We have prepared
cynomolgus ES cells genetically marked with the green
fluorescent protein (GFP), The cells were transplanted into
the allogeneic fetus, taking advantage of the fact that the
fetus is so immunologically immature as not to induce immune
responses to transplanted cells and that fetal tissue
compartments are rapidly expanding and thus providing space
for the engraftment.
Methods. Cynomolgus ES cells were genetically modified to
express the GFP gene using a simian immunodeficiency viral
vector or electroporation, These cells were transplanted in
utero with ultrasound guidance into the cynomolgus fetus in
the abdominal cavity (n=2) or liver (n=2) at the end of the
first trimester. Three fetuses were delivered 1 month after
transplantation, and the other, 3 months after
transplantation Fetal tissues were examined for transplanted
cell progeny by quantitative polymerase chain reaction and in
situ polymerase chain reaction of the GFP sequence.
Results. A fluorescent tumor, obviously derived from
transplanted ES cells, was found in the thoracic cavity at 3
months after transplantation in one fetus. However,
transplanted cell progeny were also detected ( 1%) without
teratomas in multiple fetal tissues. The cells were solitary
and indistinguishable from surrounding host cells
Conclusions. Transplanted cynomolgus ES cells can be
engrafted in allogeneic fetuses. The cells will, however,
form a tumor if they ``leak'' into an improper space such as
the thoracic cavity.
[[Page S7596]]
____
[From the American Journal of Pathology, June 2005]
Stem Cells, Tissue Engineering and Hematopoietic Elements: Teratoma
Formation Leads to Failure of Treatment for Type I Diabetes Using
Embryonic Stem Cell-Derived Insulin-Producing Cells
(By Takahisa Fujikawa)
Embryonic stem (ES) cells have been proposed to be a
powerful tool in the study of pancreatic disease, as well as
a potential source for cell replacement therapy in the
treatment of diabetes. However, data dem onstrating the
feasibility of using pancreatic islet-like cells
differentiated from ES cells remain controversial. In this
study we characterized ES cell-derived insulin-expressing
cells and assessed their suitability for the treatment of
type I diabetes. ES cell-derived insulin-stained cell
clusters expressed insulin mRNA and transcription factors
associated with pancreatic development. The majority of
insulin-positive cells the clusters also showed
immunoreactivity for C-peptide. Insulin was stored in the
cytoplasm and released into the culture medium in a glucose-
dependent manner. When the cultured cells were transplanted
into diabetic mice, they reversed the hyperglycemic state for
3 weeks, but the rescue failed due to immature teratoma
formation. Our studies demonstrate that reversal of
hyperglycemia by transplantation of ES cell-derived insulin-
producing cells is possible. However, the risk of teratoma
formation would need to be eliminated before ES cell-based
therapies for the treatment of Diabetes are considered.
____
[From Somatosensory and Motor Research, Mar./June 2005]
Transportation of Apoptosis-Resistant Embryonic Stem Cells Into the
Injured Rat Spinal Cord
(By Michael J. Howard)
Abstract
Murine embryonic stem cells were induced to differentiate
into neural lineage cells by exposure to retinoic acid.
Approximately one million cells were transplanted into the
lesion site in the spinal cords of adult rats which had
received moderate contusion injuries 9 days previously. One
group received transplants of cells genetically modified to
over-express bel-2, which codes for an anti-apoptotic
protein. A second group received transplants of the wild-type
ES cells from which the bcl-2 line was developed. In the
untransplanted control group, only medium was injected.
Locomotor abilities were assessed using the Basso, Beattie
and Bresnahan (BBB) rating scale for 6 weeks. There was no
incremental locomotor improvement in either transplant group
when compared to control over the survival period. Morbidity
and mortality were significantly more prevalent in the
transplant groups than in controls. At the conclusion of the
6-week survival period, the spinal cords were examined. Two
of six cords from the bc-2 group and one of 12 cords from the
wild-type group showed gross evidence of abnormal growths at
the site of transplantation. No similar growth was seen in
the control. Pathological examination of the abnormal cords
showed very large numbers of undifferentiated cells
proliferating the injection site and extending up to 1.5 cm
rostrally and caudally. These results suggest that
transplanting KD3 ES cells, or apoptosisresistant cells
derived from KD3 line, into the injured spinal cord does not
improve locomotor recovery and can lead to tumor-like growth
of cells, accompanied by increased debilitation, morbidity
and morality.
____
[From Diabetologia, Feb. 14, 2004]
Insulin Expressing Cells From Differentiated Embryonic Stem Cells Are
Not Beta Cells
(By S. Sipione)
Abstract
Aim/hypothesis. Embryonic stem (ES) cells have beer
proposed as a potential source of tissue for transplantation
for the treatment of Type 1 diabetes. However studies showing
differentiation of beta cells from ES cells are
controversial. The aim of this study was to characterise the
insulin-expressing cells differentiated in vitro from ES
cells and to assess their suitability for the treatment of
diabetes.
Methods. ES cell-derived insulin-expressing cells were
characterised by means of immunocytochemistry, RT-PCR and
functional analyses. Activation of the Insulin I promoter
during ES-cell differentiation was assessed in ES cell lines
transfected with a reporter gene. ES cell-derived cultures
were transplanted into STZ-treated SCID-beige mice and blood
glucos concentrations of diabetic mice were monitored for 3
weeks.
Results. Insulin-stained cells differentiated from E cells
were devoid of typical beta-cell granules, rarely showed
immunoreactivity for C-peptide and were mostly apoptotic. The
main producers of proinsulin/insulin in these cultures were
neurons and neuronal precursors and a reporter gene under the
control of the insulin I promoter was activated in cells with
a neuronal phenotype. Insulin was released into the
incubation medium but the secretion was not glucose-
dependent. When the cultures were transplanted in diabetic
mice they formed teratomas and did not reverse the
hyperglyceamic state.
Conclusions/Interpretation. Our studies show that insulin-
positive cells in vitro-differentiated from ES cells are not
beta cells and suggest that alternative protocols, based on
enrichment of ES cell-derived cultures with cells of the
endodermal lineage, should be developed to generate true beta
cells for the treatment of diabetes.
The PRESIDING OFFICER. Under the previous order, the minority is in
control of the next 30 minutes.
Mr. HARKIN. Mr. President, I was going to ask the Senator from
Kansas--I will even do it on my time. I guess our next speaker is not
here right now. If the Senator from Kansas would perhaps engage me in a
colloquy, I would ask about the gentleman whose picture he has up
there. How is he doing now? I understand that, frankly, while his
Parkinson's was relieved for a while, it has reverted and he is back in
his previous state. Does the Senator know about that?
Mr. BROWNBACK. Yes. If you caught my comments on the floor, I stated
that is part of the tragedy here. He had 5 years Parkinson's free,
wants an additional treatment using the same adult stem cell procedure
he had before that worked, and can't get it. We don't have sufficient
funding to move that on forward.
Mr. HARKIN. I say to my friend, I don't understand that. I have a
chart here that shows stem cell funding, embryonic stem cell funding,
is $38.3 million last year and adult stem cell funding is $200 million.
You are telling me out of $200 million they can't help one individual?
Plus, I ask my friend from Kansas, if this is so promising, why is
the entire Parkinson's network that represents all the people with
Parkinson's disease 100 percent behind H.R. 810? Why are they so
supportive of H.R. 810 and not this approach?
Mr. BROWNBACK. If I could answer on both of those, I would have
printed in the Record the funding over the past 4 years for both
embryonic and adult and cord blood stem cells. We put about half a
billion in embryonic, both animal and human, over the past 5 years. I
ask unanimous consent to have this printed in the Record, to point to
the level of funding we have put in both of those
There being no objection, the material was ordered to be printed in
the Record, as follows:
U.S. FEDERAL TAXPAYER FUNDING, TOTAL NIH STEM CELL RESEARCH, FY 2002-2006
[Dollars in millions] \1\
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2002 actual FY 2003 actual FY 2004 actual FY 2005 actual Combined total
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Non- Non- Non- Non- Non-
embryonic Embryonic Total embryonic Embryonic Total embryonic Embryonic Total embryonic Embryonic Total embryonic Embryonic Total
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Human, Subtotal...................... 170.9 10.1 181.0 190.7 20.3 211.0 203.2 24.3 227.5 199.4 39.6 239.0 764.2 94.3 858.5
Nonhuman Subtotal.................... 134.1 71.5 205.5 192.1 \2\ 113.5 305.6 235.7 \2\ 89.3 325.0 273.2 97.0 370.2 835.1 371.3 1206.3
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NIH, Total........................... 305.0 81.6 386.6 382.9 \2\ 133.8 516.6 439.0 \2\ 113.6 552.5 472.5 136.7 609.2 1599.4 465.7 2064.9
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers may not add due to rounding.
\2\ Decrease from FY03 to FY04 is the result of a change in methodology used to collect nonhuman embryonic funding figures. This methodology change also contributed to an increase in nonhuman non-embryonic.
Mr. BROWNBACK. Second, I would point out on Parkinson's, I don't know
why the Parkinson's advocacy community would support that. I find it
hard to believe they would oppose us doing more work in this field. I
would simply ask you, or others, if we have a place that is working and
we have another place that is producing tumors, why wouldn't you put
more in a place that is working?
Mr. HARKIN. I say to my friend from Kansas--and I see Senator Nelson
is here to speak. He had previously been
[[Page S7597]]
scheduled to do so--first, I didn't see all the figures the Senator
sent to the desk. I would like to see those. I heard him talk about a
half billion dollars. Frankly, what the Senator from Kansas is talking
about is animal embryonic. We are talking about human--human
experiments here, not animal.
Mr. BROWNBACK. If I could respond?
Mr. HARKIN. I am more interested in the human than I am about human
and animal.
Second, on cancer and tumors, it is my understanding--I am not a
scientist, but in talking with the scientists--the fact that an
undifferentiated stem cell causes cancer is exactly what they are
looking for. It is the gold standard. I thought it was the gold
standard for determining whether you have an embryonic stem cell.
Let me see if I can repeat it as told to me. If you derive a stem
cell line from an embryo, you don't really know if you have stem cells.
So the scientists take the undifferentiated cells and put them in a
mouse to see if it causes cancer. That is the gold standard--to see
whether there is a stem cell line.
No one is talking about putting undifferentiated cells into your body
or mine or anyone else's. We are talking about undifferentiated cells
and then finding how they make nerve cells, how they make heart cells,
how they make tissue cells, how they make brain cells. Only after they
are differentiated would they then be put into a person, not
undifferentiated.
I hear all about the terms. I heard that earlier this morning. I
thought I would check up on it. That is what I found out.
I would be glad to engage in a colloquy.
Mr. COBURN. Mr. President, let me clarify for the record. I think it
is very important. There is a difference between cancer and teratoma.
They use the formation of teratomas to make a differentiation of
whether this is a part of the cell. That is not a cancer. Teratomas are
not necessarily cancer. They are tumors but not necessarily cancer.
Mr. HARKIN. They are tumors. That is what I heard the Senator say.
Mr. COBURN. If you do not have a tumor, I would just as soon have a
teratoma as cancer.
Mr. HARKIN. I don't know. I am a little confused. Is the Senator
saying, if a stem cell has been introduced and is undifferentiated, it
causes cancer or teratoma?
Mr. COBURN. No. The Senator alluded to the fact that there is a gold
standard of whether an embryonic stem cell is pluripotent or whether it
produces a teratoma. That means it has components of the three layers
of an embryo--exoderm, endoderm, and mesoderm--which create all the
other tissues.
Mr. HARKIN. But the fact is the inference from some of the
statements, I think, is that thus far stem cells, when introduced,
cause cancer. That is not so. That has not been proven. That has not
been proven at all.
Mr. COBURN. It has. Most of the time teratoma.
Mr. BROWNBACK. Mr. President, I submitted for the Record seven peer-
reviewed articles on the creation of tumors.
Mr. HARKIN. Tumors but not cancer.
Mr. BROWNBACK. We have been down this road before. We tried this on
the fetal tissue research. Remember that debate of 10 to 15 years ago.
They had fast-growing cells, Parkinson's, and heart disease. When we
inserted them into actual human patients, here is what it did. It
created disastrous results because they formed all sorts of tissues
along with cancer. We have been here before, as the Senator knows, on
trying to get these sort of different cells from other bodies into one.
Mr. HARKIN. We have gone down a lot of blind alleys in medical
research in the past. I have often said that one of the reasons for
basic research is that you have 11 doors that are closed. The answer to
the problem and the answer to your endeavor may be behind one of those
doors. When you have enough funding to open one door, you know what the
odds are against you finding it. Or if you have funding for half, then
you know what the odds are against you opening the right door. A lot of
doors don't lead to anything. A lot of basic research goes down the
path, and they find out that is not the answer. So they have to shift
to something else. That happens all the time. That is what basic
research is all about.
I do not know the specific thing. I am not surprised that many things
in the past that scientists have gone down the road on have not led to
something curative or therapeutic or something like that which helps
us.
That doesn't mean that we have tried something before with
devastating effects which doesn't say that we can't then do embryonic
stem cell research.
I get back to the point that when you have almost every disease group
in this country supporting the bill that is before us, H.R. 810, you
have Nobel laureates, scientists, doctors, and you have 19 Directors of
NIH saying that thi has great potential, then I say, again, to my
friends that you have to make either one of two assumptions. Either all
of these people have been hoodwinked and they do not know what they are
talking about or they have no care or concern about ethics or morals or
anything else. I think both assumptions are wrong. I think these people
know. They are informed. They may not know every little thing medical
doctors might know, but they know the potential.
Second, I think they are vastly ethical and moral people.
I hope we will have some further colloquies on this later.
Mr. BROWNBACK. I would love to respond with a quick response. I think
a third option is people are kind of interested in what these cells
will do. I quoted from Lord Winston, a British stem cell researcher,
saying it is an interesting area, but it is not going to produce any
likely cures in my lifetime. But they are curious. They are looking at
it and saying it is an interesting area of research. If we are going to
cure people, let us cure people and let us talk about that kind of
research.
The Senator has been very kind to let me speak.
Mr. HARKIN. The Senator has been very kind. I think we can engage at
some other point.
I yield the floor.
The PRESIDING OFFICER. The Senator from Florida.
Mr. NELSON of Florida. Mr. President, we just heard a great deal of
discussion and disagreement. My bottom line on this whole issue of stem
cell research is that a vast majority of the medical and scientific
community feels that this is a process which would lead to medical
breakthroughs in the fight against disease. To this Senator, that is
worth exploring.
There is hardly a Senator here whose life has not been touched by
disease, in one way or another, through their family. In this
particular Senator's life, my family has been touched by disease, and
we don't know the cause of it. Amyotrophic lateral sclerosis, or ALS,
otherwise known as Lou Gehrig's disease. It took down the great
baseball player, Lou Gehrig. For years, the researchers have looked and
looked and researched and researched and have not found a cure. The ALS
community, along with many other communities, is concerned about the
treatment and cure of diseases on which stem cell research might offer
a clue.
Researchers believe that stem cells may have the potential to treat
over 100 million Americans who suffer from a variety of conditions,
many of which you heard already discussed on the floor of the Senate
today.
There is a T-shirt that I jogged in this morning. It was given to me
by the Miami Project. One of the most graphic symbols on this T-shirt
is the international symbol of a wheelchair-bound person, and that
international symbol suddenly starts to become upright and walks. The
Miami Project was put together after the tragedy of a spinal cord
injury to the son of Nick Buoniconti, the all-pro linebacker of the
great Miami Dolphins team, the undefeated team of 1972. When his son
was at a Citadel football game, he suffered that injury. Now the son
and the father are both behind Miami Project, trying to find a cure for
spinal cord injuries. And all the medical researchers feel that stem
cell research is very promising for Alzheimer's, Parkinson's,
cardiovascular disease, cancer, and I already mentioned ALS and
diabetes.
If that occurred, think what that would mean as we grapple with the
Federal budget that is going out of control because of the accelerating
cost of Medicare. If we were able to
[[Page S7598]]
treat and cure some of these diseases, think about how much cost
savings that would create. And clearly, in this Senator's mind, a
secondary consideration is the fact of eliminating, almost
miraculously, the plague of these diseases by the stem cells that have
the ability to reproduce themselves and potentially develop into
different kinds of cells in the human body.
Of course, you have already heard in the debate today about the
extensive research and being able to treat certain diseases. When
confronted with this a few weeks before September 11, 2001, the
President announced that the administration would only allow Federal
funding for this research to be used on existing colonies of embryonic
stem cells. Of course, you have heard the chorus in the scientific
community, since then, expressing concern about the quality, the
longevity, and the availability of these lines--and they believe that
the research advancement requires new embryonic stem cell lines. The
key is to increase the availability of the quality embryonic stem cell
lines.
The current rules have limited the supply and have resulted in fewer
investigators focusing their efforts on stem cell research. Therefore,
progress has been limited because of Federal funding in this research
being limited. We have the ability to fix that. We can do that in this
bill before the Senate.
This Senator intends to support this bill. This bill lifts the
President's current restriction that allows researchers to receive the
Federal funding for the study of embryonic stem cells. These stem cells
can only be derived from embryos originally created for fertility
treatments and that are willingly donated by patients and, I might say,
that are slated to be discarded.
We will get a substantial majority of votes in the Senate. Although
we hear the threats of a veto, it would be my hope the President will
reexamine this issue. We are only talking about one kind of stem cell
research. This is the stem cells that come through a rather complicated
progress, from a fertilized egg that was going to be discarded.
There is another promising way of doing this called somatic cell
nuclear transfer where it is not even a fertilized egg. You take an
egg, scoop out the nucleus, take a stem cell from the donor--it can be
from a skin cell--put that nucleus in, and activate the process of
growing cells. That process of stem cell research has enormous promise.
This Senator has heard from thousands of Floridians who suffer on a
daily basis from some of these terrible diseases. The Senate has the
ability to bring hope to these people. It is time to act. The Senate
should pass this bill and pass it with a fairly sizable majority,
giving scientists the tools they need to search for cures.
I yield the floor.
The PRESIDING OFFICER. The Senator from Illinois
Mr. OBAMA. Mr. President, a few weeks ago I was visited by two of my
constituents--Mary Schneider and her son Ryan.
When Ryan was just 2 years old, his parents and doctors noted severe
delays in his motor and speech development, and he was diagnosed with
cerebral palsy. His parents were devastated, as the prognosis for any
children with cerebral palsy is quite grim, and given the severity of
Ryan's condition, his doctors didn't have much hope for his
improvement.
Yet, his parents had hope. Because when Ryan was born, his parents
had saved his cord blood, a viable but limited source of stem cells.
They found a doctor at Duke University who was willing to perform an
experimental infusion with these cells to see if they might improve his
condition.
They did. In fact, they seem to have cured him.
Within months of the infusion, Ryan was able to speak, use his arms,
and eat normally, just like any other child--a miracle his family had
once only dreamed of.
Ryan's story exemplifies the power and the promise of stem cells to
treat and cure the millions of Americans who are suffering from
catastrophic, debilitating and life-threatening diseases and health
conditions.
Each year, 100,000 Americans will develop Alzheimer's disease. Over 1
million adults will be diagnosed with diabetes this year, which can
lead to complications such as blindness, damaged nerves and loss of
kidney function. And there are far too many individuals with spinal
cord injuries who are struggling to maintain mobility and independence.
For most of our history, medicine has offered little hope of recovery
to 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 life-saving applications of adult stem cell research.
Patients with leukemia or lymphoma often undergo bone marrow
transplants.
One of my old law partners back in Chicago underwent a bone marrow
transplant at the age of 30. It is a type of stem cell transplant which
can significantly prolong life or permanently get rid of cancer. This
is what happened, fortunately, to my partner. He is now cancer free.
This therapy has been used successfully for decades and is saving lives
every day.
Now, here is the problem. This particular breakthrough of adult stem
cells has its limitations. Adult stem cells, as has already been
mentioned by the distinguished Senator from Iowa, such as those which
are used in bone marrow transplants can only be collected in small
quantities. They may not be a match for the patient. They have limited
ability to transform into specialized cells.
Cord blood, like the kind Ryan used, has limitations as well. If, for
example, Ryan's condition should deteriorate or he should have another
illness, there is simply not enough cord blood cells left for a second
use. His mother has told us that the few remaining cells would have to
be cloned to get enough cells for future use or they would have to
obtain stem cells from another source.
These and other difficulties are the reason scientists have started
to explore other types and other sources of stem cells, including
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. It
makes sense for us to expand and accelerate research using these
embryos, just as we should continue to explore the viability of adult
stem cell use and cord blood use.
All over the country, exciting progress is being made in the area of
embryonic stem cell research. At the University of Illinois, they are
discovering that stem cells have the potential to treat blood
disorders, lung diseases, and heart damage. At Johns Hopkins,
researchers use mouse embryonic stem cells to restore damaged nerves
and restore mobility in paralyzed rats. One cannot help but think it is
a matter of when, not if, the research will be able to help those who
have lost the ability to walk.
For these reasons, I am proud to be a longtime supporter of greater
stem cell research. While I was a member of the Illinois Senate, I was
the chief cosponsor of the Ronald Reagan Biomedical Research Act, which
would specifically permit embryonic stem cell research in Illinois and
establish a review of this research by the Illinois Department of
Public Health.
I am proud to be a cosponsor of the stem cell bill before the Senate
today. This bill embodies the innovative thinking we as a society
demand and medical achievement requires. By expanding scientific access
to embryonic stem cells which would be otherwise discarded, this bill
will help our Nation's scientists and researchers develop treatments
and cures to help people who suffer from illnesses and injuries for
which there currently are none.
The bill is not without limits. It requires that scientific research
also be subject to rigorous oversight. I recognize there are serious
moral and ethical issues surrounding this debate. I am respectful of
those on the other side. I also realize that we are not talking about
harvesting cells that would
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have been used to create life. We are not talking about cloning humans.
We are talking about using stem cells that would otherwise have been
discarded and lost forever. We are talking about using those stem cells
to possibly save the lives of millions of Americans.
Democrats want this bill passed. Conservative pro-life Republicans
want this bill passed. By large margins, the American people want this
bill passed. It is only the White House right now that is standing in
the way of progress, standing in the way of so many potential cures.
I ask, after this bill passes--because I am confident it will pass in
the Senate--that the President think about this before he picks up his
pen to deliver his first veto in 6 years. I ask that he think about
Ryan Schneider and his parents and all the other families sitting and
waiting and praying for a cure, hoping that somewhere a researcher or
scientist will find an answer.
There was a time in the middle of the last century when America
watched helplessly as a mysterious disease left thousands, especially
children, disabled for life. The medical community worked tirelessly to
fight to try to find a cure, but they needed help. They needed funding
to make their research possible.
With a world war raging and the country still emerging from the
Depression, the Federal Government could hav ignored their plight or
told them to find their own cure, let it be funded privately, but that
is not what happened. Instead, FDR helped to galvanize a community of
compassion and organized the March of Dimes to find the cure for polio.
While Roosevelt knew that his own polio would never be cured by the
discovery of a vaccine, he also knew that at its best, the Government
can be used as a force to accomplish together what we cannot achieve on
our own. So the people began to care. The dimes piled up, and the
funding started to flow. And 50 years ago, Jonas Salk discovered the
polio vaccine.
Americans are looking for that kind of leadership today. All over the
country, patients and families are waiting today for Congress and the
President to open the door to the cures of tomorrow. At the dawn of
this new century, we should approach this research with the same
passion, the same commitment that has led to so many cures and saved so
many lives throughout our history. I urge my colleagues to support this
bill.
I yield back the remainder of my time.
Mr. HARKIN. How much time remains on our side?
The PRESIDING OFFICER. The minority has 3 minutes.
Mr. HARKIN. Mr. President, I yield that time to the Senator from
Kentucky. We had a colloquy earlier that maybe we can find some time
before 5 for Senator Dorgan to speak. I yield the floor.
The PRESIDING OFFICER. Under the previous order, the majority is in
control of the next 30 minutes.
The Senator from Kentucky.
Mr. BUNNING. Mr. President, I come to the Senate today to speak on
the three bills related to stem cell research. One of these bills is
wrong, but I believe that the other two are worthy pieces of
legislation.
Stem cell research is a controversial issue in the medical,
scientific, and religious communities, as well as in Congress. I am not
opposed to stem cell research; however, I am 100 percent opposed to
embryonic stem cell research. This is why I oppose H.R. 810, the Stem
Cell Research Enhancement Act of 2005. This bill would remove all
current protections against the destructive use of embryos for
harvesting stem cells. I firmly believe it is wrong to take these
sources of life and destroy them, even if it is for a benign purpose
such as medical research.
Current Federal policy on stem cell research developed out of a
compromise between proponents of research and those who endeavor to
protect life at its earliest stages, brokered by President Bush. This
is the first administration to allow Federal funding of embryonic stem
cell research. Today's policy allows Federal funds to be used for
embryonic stem cell lines that were in existence prior to August 9,
2001.
As an opponent of the destruction of human embryos, I believed the
Bush administration's decision to allow the embryonic stem cell
research was misguided. H.R. 810 goes even further than the current
policy. It cancels the protections of the 2001 cutoff for research by
allowing research of all embryonic stem cells created from in vitro
fertilization treatments. This legislation would move us in the wrong
direction on this issue.
Some have said that these excess embryos which would be used for
research would be destroyed anyway. However, I do not think this makes
ethical sense. Just because these budding lives will not survive does
not mean that we should ghoulishly conduct experiments on them.
I believe there is a disconnect between what many Americans believe
about this issue and what the facts are. For one, we are debating the
use of Federal funds for embryonic stem cell research. We are not
debating the legality of embryonic stem cell research. Any company or
organization that wants to conduct or fund embryonic stem cell research
may do so. I just do not think taxpayers should be forced to pay for
it.
Also, there are different kinds of stem cells. Adult stem cells, such
as those derived from cord blood tissue, do not require the destruction
of a human embryo. Why walk down such a dangerous ethical path when
there is no need to do so? These adult stem cells have proven very
effective in combating several serious conditions, such as diabetes and
spinal cord injuries, among others.
This leads me to another point. We have seen the benefits that come
from adult stem cell research. However, we have yet to see any tangible
benefits from any embryonic stem cell research. Many scientists agree
that these kinds of stem cells might--I say ``might''--be able to help
fight disease someday, but it has not happened yet. We are talking
about ending human life when no lives have been saved yet. Who knows
how many human embryos we will have to destroy before any tangible
progress is made.
That being said, I am pleased to see that the Senate is considering
S. 2754, the Alternative Pluripotent Stem Cell Therapies Enhancement
Act. This bill could very well remove the most contentious issues of
this debate. Embryonic stem cells are pluripotent, meaning that they
could potentially have a wide variety of uses. It is this quality that
drives the supporters of embryonic stem cell research to their
position. However, great strides have been made in deriving pluripotent
stem cells from sources that do not destroy embryos.
S. 2754 would authorize Federal funding to conduct research on the
creation of nonembryonic pluripotent stem cells. If successful, we
would be able to end this debate by funding a morally acceptable
replacement for research involving human embryo destruction. I urge the
Senate to adopt this measure.
The final bill the Senate is debating on the subject is S. 3504, the
Fetus Farming Prohibition Act. I fully support passage of this
legislation. This bill would ban research from fetal farms where human
embryos are implanted in nonhuman uteruses. It would also ban embryos
from human pregnancies created specifically for research.
Most people would find these requirements to be self-evident.
However, some groups have said this is unnecessary because research
already follows ethical guidelines that forbid this. That may be the
case, but I believe we should take these ethical guidelines and give
them the force of law to prevent the possibility of such gruesome
methods ever being used by researchers. I urge my colleagues to pass
this bill.
I do not like to see people with medical conditions suffer. However,
I believe many advocates of embryonic stem cell research are playing on
the hopes and griefs of many people whose lives are touched by illness.
We are at an ethical crossroads with this issue. We must stay true to
our values of respecting life. It seems foolish to stubbornly barrel
ahead with Federal funding for embryonic stem cell research when, with
a small bit of patience, we can put aside the moral and ethical
concerns and proceed down a path we can all agree upon.
In closing, I firmly believe we cannot create life and then destroy
it in order
[[Page S7600]]
to save another life. I urge my colleagues to vote against the Stem
Cell Research Enhancement Act and to support S. 2754 and S. 3504.
Mr. President, I yield back the remainder of my time.
The PRESIDING OFFICER. The Senator from Oklahoma.
Mr. COBURN. Mr. President, I want to spend a few minutes to kind of
outline some of the statements that have been made. To just show how
off base from reality some of them are, we heard there was a ban on
embryonic stem cell research. There is no ban on embryonic stem cell
research. As a matter of fact, the American people paid $40 million
this last year on embryonic stem cell research--human, $40 million. So
there is no ban. And considering that, there is a significant industry
in the private sector that is researching it.
We heard there are only 21 cell lines around, available. There are
400 cell lines available to scientists. There are 21 that Federal
dollars can be spent on. So let's be real clear about what the real
facts are.
We also heard from the Senator from Florida that all medical
researchers believe that embryonic stem cell research is the best hope.
That could not be further from the truth. All of them do not. As a
matter of fact, there is a large number who do not believe that way at
all, based on not ethical concerns, on scientific concerns. They think
it is not an acceptable way.
We heard the Senator from Illinois saying that adult stem cells can
only be collected in small quantities. That is not true at all. Many
adult stem cell lines are reproductive of themselves. They are
progenitor cells. They reproduce themselves. They come from amnionic
membrane. They come from bone marrow. They come from endometrial
lining. They come from placental tissue. They come from cord blood.
They come from the spleen and the liver. They come from all sorts of
areas in our body.
We heard the Senator from California say we should let the scientists
decide, not the Senators. Let's talk about Tuskegee. We let the
scientists decide that one. I can think of two or three more instances
in the 20th century when we let the scientists decide, and we went down
a path that all of us were grieved over.
When Senator Specter opened the debate today, there was, again, the
assumption, in his first statement, that there is no embryonic fetal
stem cell research. Not true. He also said none of the others have the
potential of embryonic stem cell research. Well, I think there is a
large body of science and a larger body of scientists who would
disagree with that, especially as they study the new breakthroughs on
germ cell pluripotent stem cells.
I am going to ask to have printed in the Record a Rand study on the
available numbers of human embryos, where in fact there are 400,000.
But they outline, in great detail, that the fact is, a very small
percentage of those are available for fetal research. They also outline
in great detail so the American public can know that for every two
embryos you are going to thaw, one of those two will die during the
thawing process.
So for this limited number, the most number of new cell lines, if you
took all that are available today, would be less than what is available
in the world today. It is 273 cell lines. So we have this great big
demand, that we are going to get all this, but what we are going to get
is less than what is out in the world today.
Mr. President, I ask unanimous consent that the Rand study I referred
to be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
[From the Rand Law & Health Research Brief]
How Many Frozen Human Embryos are Available for Research?
Frozen human embryos have recently become the focus of
considerable media attention. Frozen embryos are a potential
source of embryonic stem cells, which can replicate
themselves and develop into specialized cells (e.g., blood
cells or nerve cells). Researchers believe that such cells
might be capable of growing replacement tissues that could be
used to treat people suffering from a number of diseases,
including cancer, Alzheimer's disease, and diabetes. Among
the most contentious issues in the stem cell debate are
whether frozen embryos should be used to produce stem cells
for research purposes and whether it is appropriate to use
federal funds for research involving human embryos.
Many of the proposed resolutions to the embryonic stem cell
debate are based on assumptions about the total number of
frozen human embryos in the United States and the percentage
of that total that is available for research. Accurate data
on these issues, however, have not been available. Guesses on
the total number of embryos have ranged wildly from tens of
thousands to several hundred thousand.
RAND researchers Gail L. Zellman and C. Christine Fair,
together with the Society of Assisted Reproductive Technology
(SART) Working Group led by David Hoffman, MD, have completed
a project designed to inform the policy debate by providing
accurate data on the number of frozen embryos in the United
States and how many of those embryos are available for
research purposes. Their findings include the following:
Nearly 400,000 embryos (fertilized eggs that have developed
for six or fewer days) have been frozen and stored since the
late 1970s.
Patients have designated only 2.8 percent (about 11,000
embryos) for research. The vast majority of frozen embryos
are designated for future attempts at pregnancy.
From those embryos designated for research, perhaps as many
as 275 stem cell lines (cell cultures suitable for further
development) could be created. The actual number is likely to
be much lower.
vast majority of frozen embryos are held for family building
The practice of freezing embryos dates back to the first
infertility treatments in the mid-1980s. The process of in
vitro fertilization often produces more embryos than can be
used at one time. In the United States, the decision about
what to do with the extra embryos rests with the patients who
produced them.
The RAND-SART team designed and implemented a survey to
determine the number and current disposition of embryos
frozen and stored since the mid-1980s at fertility clinics in
the United States and the number of those embryos designated
for research. The survey was sent to all 430 assisted
reproductive technology facilities in the United States, 340
of which responded. Estimates for nonresponding clinics were
developed using a statistical formula based on a clinic's
size and other characteristics. The results show that as of
April 11, 2002, a total of 396,526 embryos have been placed
in storage in the United States. This number is higher than
expected; previous estimates have ranged from 30,000 to
200,000.
Although the total number of frozen embryos is large, the
RAND-SART survey found that only a small percentage of these
embryos have been designated for research use. As the figure
illustrates, the vast majority of stored embryos (88.2
percent) are being held for family building, with just 2.8
percent of the total (11,000) designated for research. Of the
remaining embryos, 2.3 percent are awaiting donation to
another patient, 2.2 percent are designated to be discarded,
and 4.5 percent are held in storage for other reasons,
including lost contact with a patient, patient death,
abandonment, and divorce.
embryos available for research do not have high development potential
Although the 11,000 embryos designated for research might
seem like a large number, the actual number of embryos that
might be converted into stem cell lines is likely to be
substantially lower. Because assisted reproductive technology
clinics generally transfer the best-quality embryos to the
patient during treatment cycles, the remaining embryos
available to be frozen are not always of the highest quality.
(High-quality embryos are those that grow at normal rates.)
In addition, some of the frozen embryos have been in storage
for many years, and at the time that some of those embryos
were created, laboratory cultures were not as conducive to
preserving embryos as they are today. Some embryos would also
be lost in the freeze-and-thaw process itself.
To illustrate how such laboratory conditions might limit
the number of embryos available for research, the RAND-SART
team performed a series of calculations. Drawing upon the few
published studies in this area, they estimated that only
about 65 percent of the approximately 11,000 embryos would
survive the freeze-and-thaw process, resulting in 7,334
embryos. Of those, about 25 percent (1,834 embryos) would
likely be able to survive the initial stages of development
to the blastocyst stage (a blastocyst is an embryo that has
developed for at least five days). Even fewer could be
successfully converted into embryonic stem cell lines. For
example, researchers at the University of Wisconsin needed 18
blastocysts to create five embryonic stem cell lines, while
researchers at The Jones Institute used 40 blastocysts to
create three lines.
Using a conservative estimate between the two conversion
rates from blastocyst to stem cells noted above (27 percent
and 7.5 percent), the research team calculated that about 275
embryonic stem cell lines could be created from the total
number of embryos available for research. Even this number is
probably an overestimate because it assumes that all the
embryos designated for research in the United States would be
used to create stem cell lines, which is highly unlikely.
The RAND-SART survey found that almost twice as many frozen
embryos exist in the United States as the highest previous
estimate. Only a small percentage of these embryos are
available for research because the
[[Page S7601]]
vast majority are reserved for family building. Among those
that are in principle available for research, some have been
in storage for more than a decade and were frozen using
techniques that are less effective than those that are
currently available.
Mr. COBURN. Now, why do we want multiple cell lines? It goes back to
the issue I have been talking about all day. It is called tissue
rejection. That is the wonder of adult stem cells and germ cell
pluripotent stem cells versus embryonic. With embryonic, there is
rejection because there is an allergy to the foreign tissue. It is
called the HLA, histocompatibility complex. The only way around that,
with fetal embryonic stem cells, is to clone yourself--the only way you
will get around it. And it will only work well in women. Only if you
clone yourself with your own egg do you avoid all the allergy
implications of foreign tissue.
So I think it is very important that we--it is OK to have this
debate, but some of the claims we hear--we actually heard, and I know
he did not mean this, Senator Specter talking about embryos injected
into the pulp of the tooth to create a new set of teeth. He did not
mean embryos. He meant pluripotent stem cells. But you do not want
pluripotent. What you want is the epidermal stem cells that produce
teeth in the first place. That is what is great about adult stem cells.
We are going to be able to do that with adult stem cells.
He also stated that embryonic stem cell research is outstripping all
of the research. That is not true. It is not true at all. The vast
majority of success in stem cells today lies not with embryonic stem
cells, it lies with everything but embryonic stem cells.
Now, I do not deny as a scientist that would be a wonderful area in
which to work. There is lots unknown, and if you are a scientist today,
and they say you can go to this area where there are all these areas
where you can work and go and move and everything, it is a fun area of
research. But it is loaded with hazards, just like the Senator from
Kansas talked about, in terms of fetal tissue. The fact is, as we may
someday learn how to turn on and turn off some of these cell lines, we
do not know that yet. It is fine to perfect that in animals. It is not
fine to perfect that in human clinical trials until we have that
absolutely controlled. I do not have any trouble with what we are doing
now, doing that in the private sector.
But the question is, do we ask American taxpayers to use their money
to destroy embryos--embryos for which there are 2 million people in the
country who would love to adopt--do we ask them to destroy that with
their tax money so we can do that research, even though it is occurring
in the private sector at a far greater rate than it is in the public
finance sector?
So I think this really boils down to two questions: false choices and
false promises. Let me outline them. The false promise is that only
embryonic stem cells are going to solve the problem. It is not true.
The second promise is we are going to get treatments, but we are not
going to have to clone. You are going to have to clone if you are going
to get treatments from embryonic stem cells.
No. 3 is that adult stem cells and the pluripotent lines, as well as
germ cell lines, will not be able to do what embryonic stem cells do.
That is not proven anywhere in the scientific literature. That is a
false promise.
And No. 4 is the false promise issue that you cannot take adult stem
cells and dedifferentiate, move backwards, to make them pluripotent,
which we are seeing great science with an enzyme today called reversa.
So those are the false promises that are out there.
Now, there are four false choices, I believe. One is that there is no
cure without embryonic stem cells. That, for sure, the evidence does
not show. Another is that there will not be any research unless the
Government pays for it. That is not true at all. The research is
ongoing across the world in lots of areas without government research,
and much more so in our country outside of government research.
The third choice is that there is no life in an embryo. The fact is
there is. Now, we had one Senator talk about the fact that they are
going to be incinerated. If you talk about the 108 snowflake babies,
the other 2 or 3 organizations that are adopting those, those children
belie that fact that there is wonderful potential with the amount of
demand.
I am not saying that people who disagree with me on the ethical
issues are bad or immoral people. I am saying I am not fighting this on
ethical issues. I am fighting this on common sense, to see what things
are happening and where we are seeing success and keeping up with the
science. This debate in the Senate today is almost all about a year and
a half old, as far as the science is concerned. I am talking about the
new science. That is why I worked so hard to stay up on it.
Finally, the promise is what every scientist knows, what every
embryologist knows and every cell biologist knows, which is the mighty
mitochondria. You cannot clone without having potential rejections
unless you clone yourself with your own egg. There is different DNA in
the mitochondria and the cell cytoplasm. I appreciate the spirit of the
debate, and I hope the American people understand that it is not a
false choice of no research versus some. The question is, Do we destroy
unborn children? Two, do we give Federal dollars to do that? Thank you.
The PRESIDING OFFICER. The Senator from West Virginia is recognized.
The Senator is to be aware that the majority controls the time until 5
p.m.
Mr. BYRD. Mr. President, I am aware of that. I ask unanimous consent
that, notwithstanding and without any prejudice to any Senator, to
speak for 5 minutes on another matter.
The PRESIDING OFFICER. Is there objection?
Mr. BYRD. Not showing an interruption at this point.
The PRESIDING OFFICER. Is there objection?
Mr. DORGAN. Mr. President, reserving the right to object, my
understanding was that I would be recognized for 10 minutes following
the presentation by Senator Coburn. I don't object to anything someone
else wishes to do, provided that following that presentation, I am
recognized for 10 minutes. Would that be part of the unanimous consent
request?
Mr. BYRD. I make that part of my request.
The PRESIDING OFFICER. Is there objection?
Mr. HARKIN. If I might, as a manager, we are on strict time limits.
At 5 o'clock, Senator Kennedy gets 25 minutes and then 5 minutes goes
to Senator Reed. At 5:30, it goes back to the other side. If we take
time here and there, it spills over, and someone is going to lose time.
Mr. KENNEDY. I will be glad to yield 5 minutes of my time to the
Senator from West Virginia.
The PRESIDING OFFICER. Is there objection? Without objection, it is
so ordered.
The Senator from West Virginia is recognized.
(The remarks of Mr. BYRD are printed in today's Record under
``Morning Business''.)
The PRESIDING OFFICER. Under the previous order, the Senator from
North Dakota is recognized for 10 minutes.
Mr. DORGAN. Mr. President, all of us have great pride in being able
to serve in this great body and the purpose of it is, of course, to be
engaged in public policy debate, how to advance this country's
interests. We come to this debate today on something that is very
important, very controversial. This country's search in many areas--
social justice, science, and so many areas of our lives--is a search
that never ends. We have split the atom. We have spliced genes. We did
the human genome project, developed the owner's manual for the human
body. We invented plastics and radar and silicon chips, cured polio,
cured smallpox, built airplanes and learned to fly them, and built
rockets and walked on the moon; we invented the telephone, the
computer, and the television.
It is pretty unbelievable, but this country is hardly out of breath.
We continue to inquire, continue to search, and continue to ask
questions. Those questions, especially in science, are, in some cases,
difficult questions. We will have three pieces of legislation we will
vote on tomorrow dealing with stem cell research. One piece of
legislation prevents something that is not being done. I will not have
any problem supporting that; preventing something
[[Page S7602]]
that is not being done is not posing any difficulty for me. The second
piece of legislation authorizes that which is already authorized. I
have no difficulty with that vote either. I will be happy to support
that.
The third piece of legislation is called embryonic stem cell
research. That is the basis of the controversy being discussed today.
Those in this Chamber and those throughout this country who have lost
loved ones to dreaded diseases understand the urgency to unlock the
mysteries of these diseases. I lost a beautiful young daughter some
years ago to heart disease. I wondered then, and I wonder now, and I
will wonder for some long while, if there is anything that we could do
to unlock the mystery of that devastating killer. But it is not just
heart disease. It is diabetes, Alzheimer's, Parkinson's, cancer--the
list goes on and on.
Every day, people die. Every day, there are scientists who inquire:
What can be done? What can we do to unlock the mysteries to find cures
for these terrible diseases?
Stem cell research. Mr. President, there are 1 million people walking
on this Earth who were conceived outside of the womb in a test tube.
There are 1 million living people who were conceived through in vitro
fertilization. We had somebody testify before the Senate Commerce
Committee a few years ago, and he said none of those people should have
been born, it was wrong and in vitro fertilization should not exist. It
is wrong, he said. I disagree with him. It is the blessing to provide
the opportunity to have a family to so many couples who were childless
through in vitro fertilization, using the egg and sperm and uniting
them outside of the womb, implanting them, and providing a child for
those families.
At in vitro fertilization clinics, many more eggs are fertilized than
are used. Some are stored and frozen. Those frozen embryos at in vitro
fertilization clinics, when they are not going to be used in the
future, are discarded, simply thrown into a wastebasket. They become
waste and they are discarded. Some of my colleagues would say each and
every one of those represents murder. I don't believe that, but some of
my colleagues would insist on that position. That is murdering an
embryo. We have 400,000 of those embryos stored, cryogenically frozen,
at in vitro fertilization clinics. Around 8,000 to 11,000 of them a
year will be simply discarded.
The question is: Should we relax the ban on Federal funding of stem
cell research and allow the use of frozen embryos that otherwise are
going into a wastebasket, that otherwise are going to be discarded?
Should we allow the use of them with ethical boundaries and be
concerned about the ethics of its use for scientific research, to try
to find the cures to these terrible diseases? Should we allow that? The
answer clearly is yes.
Are we comparing someone who is suffering from Parkinson's, someone
who has Alzheimer's, someone with heart disease or cancer or diabetes
to an embryo that is going to be discarded into a wastebasket--8,000 to
11,000 of them a year? Do we find an equivalency there
Do you believe that all of those unused fertilized eggs that are
frozen at an IV clinic, an in vitro fertilization clinic, that are
discarded, that each and every one represents a murder? Some believe
that. I don't.
What is pro-life, I believe, what is life-giving is to be able to
continue in this area of science with ethical guidelines but continue
this search to unlock the mysteries of these diseases.
My colleague a moment ago said quite correctly that we don't prevent
stem cell research. He is quite right about that. This issue is the
restriction of Federal funding, and, of course, a substantial amount of
the funding for scientific research, research in health care in this
country, comes from the Federal Government.
If we take a look at what has happened with respect to the United
States and the rest of the world, we will see, because President Bush
has imposed restrictions on stem cell research, we have lost a
substantial amount of ground to the rest of the world. We are falling
far behind.
This is not about Republicans or Democrats. It is not about
conservatives or liberals. Let me quote Nancy Reagan: Science has
presented us with a hope called stem cell research, which may provide
our scientists with answers that have so long been beyond our grasp. I
just don't see how we can turn our backs on this--there are just so
many diseases that can be cured, or at least helped. We have lost so
much time already, and I just really can't bear to lose any more.
Nancy Reagan watched the ravages of Alzheimer's disease destroy her
husband, our former President, the late Ronald Reagan. I believe she
understands the urgency with which we pursue this purpose. I can read
the pain in this message, and that pain exists--my guess--with so many
in this Chamber and across the country who have watched loved ones die
because of dread diseases that have wasted away their lives. The
question is: Are we willing to do something about that? Can we do
something about that? Will we retard or will we advance science? Will
we hold back or will we encourage the scientists to search for these
cures?
I hope the Senate will do just as the House has done and indicate
that we believe that with proper ethical guidelines, stem cell research
should continue with Federal funding. I believe, as I said, this is
about saving lives, this is not about taking lives.
I understand that this is a sensitive subject. In fact, in my last
campaign for office 2 years ago, my opponent ran television commercials
saying that my position was to be supportive of planting embryos into
mommies' wombs and growing them for a while and then harvesting them
for body parts. That is the Byzantine nonsense which, unfortunately,
attends part of this debate. No one here--certainly not me--would ever
countenance anything resembling that, and yet much of the political
discussion about this issue becomes so bizarre and so Byzantine that it
is detached from reality.
The bill that is before the Senate that I just described--I am not
talking about the first two bills, the one that prevents something that
is not being done. I don't have a problem with that. Or the one that
authorizes something that is already authorized, and I have no problem
with that.
I am talking about the legislation dealing with stem cell research.
The bipartisan coalition that brought it to the Senate includes
Republicans, Democrats, conservatives, and liberals. My hope is the
Senate will act on this legislation with a veto-proof majority and
decide whatever the President does that we have made this decision and
the decision should stick.
The PRESIDING OFFICER (Mr. Alexander). The Senator's time has
expired. The Senator from Massachusetts is recognized.
Mr. KENNEDY. Mr. President, I believe I am to be recognized for 20
minutes. I would like the Chair to let me know when I have 3\1/2\
minutes remaining.
The PRESIDING OFFICER. The Chair will do that.
Mr. KENNEDY. Mr. President, I join my friend and colleague from North
Dakota in giving special recognition to Mrs. Reagan on this issue. As
someone who has been interested in this issue for some time, as many of
my colleagues have, I think all of us pay tribute to her, to a very
gracious, lovely, wonderful, warm First Lady and someone I admire so
much because after she has been to the top of the mountain, so to
speak, and entitled to a very secure and well-deserved retirement, she
is still restless about this issue and tireless about talking with
people and speaking about this issue with great knowledge, great
awareness, great understanding, and great compassion. I mention that at
this time. I think we all know this debate has moved farther down the
road toward a hopeful conclusion because of her work.
Today, the Senate begins the debate on legislation unlike any other
we have considered this year. Today's debate is not about economic gain
or loss or helping one State or one region of the country. Today's
debate is about something far more basic, something that touches the
spirit of every American. Today's debate is about hope.
Hope is one of those qualities of spirit that makes us human. Hope
allows us to dream of a better life for our children, our community,
our world, and especially for loved ones now suffering or in pain. Hope
is what stem cell research holds for the parents of children
[[Page S7603]]
with diabetes who dream of a day when their constant fears for their
children's well-being are things of the past. Hope is what stem cell
research brings to those with Parkinson's disease who long for a time
when the tremors of that disease are banished forever. Hope is what
stem cell research brings to millions of Americans who seek better
treatments and better drugs for cancer or diabetes, spinal injury, and
many other serious conditions. And hope cannot be extinguished or
destroyed, but it can be delayed.
In the Bible, the Book of Proverbs tells us:
Hope deferred makes the heart sick.
And today hearts are sick almost to the breaking point because, for
the last 5 years, the Bush administration has shut down the stem cell
research program begun at the National Institutes of Health and imposed
the arbitrary restrictions on this lifesaving research.
Hope soared anew a year ago when the House of Representatives set
aside partisan differences and courageously approved legislation to end
those restrictions and to give our scientists the tools they need to
make the progress in the fight against disease. The vote in the House
affirmed that embryonic stem cells can promote a true culture of life
by enabling fuller, longer lives for millions of our citizens. The
House voted for hope, for progress, and for life.
The supporters of this legislation in the Senate come from
backgrounds as diverse as its proponents in the House. All of the
supporters of H.R. 810, with our different backgrounds and different
faiths, representing different parts of this country, have concluded
that support of this legislation is the moral choice to make.
The legislation before us takes only two actions, but they hold the
key to medical progress.
First, our legislation overturns the restrictions on the embryonic
stem cell research imposed by Presidential order 5 years ago. That
unilateral action by the administration bypassed Congress and froze
progress in its tracks by barring the NIH from funding research on stem
cells derived after 9 p.m. eastern daylight time, August 9, 2001--an
arbitrary date and time chosen solely to coincide with a Presidential
speech.
At the time the President's order was issued, it was claimed that
over 60 independent stem cell colonies, or lines, would be available to
NIH researchers. Initially, the NIH listed 78 such lines in its
registry, but time and the unalterable facts of science have shown that
two-thirds of these lines are useless or that claims about them proved
to be an illusion.
Today, only 21 stem cell lines are available to NIH researchers, and
all of these were obtained using out-of-date methods and outmoded
techniques. Each of these 21 lines is contaminated with animal tissue
because each was cultured on a so-called feeder layer of mouse cells.
Techniques developed since 2001 have allowed scientists to grow stem
cells without mouse cells, but these are all off limits to NIH-funded
scientists because of the administration's restrictive policy.
Even if the 21 lines were not contaminated with mouse cells, they
would still be unusable for treatments. The reason is that the use of
every one of these cells is constrained by a legal contract called a
material transfer agreement, and each of these documents contains a
clause forbidding the use of the cells in patients.
Let me be clear. If the cells in the NIH registry weren't already
useless for treatment because they are contaminated, they would be
useless because the contract under which they are provided forbids
their use in patients.
Five years ago, we warned that imposing an arbitrary date restriction
on new stem cell lines would freeze progress by denying NIH researchers
access to new lines that might hold the key to medical breakthroughs,
and these fears have proven well-founded.
Since the restrictions were imposed, scientists working overseas or
with limited private funds have developed new lines with exceptional
promise for research. For example, Dr. Douglas Melton at Harvard has
derived 17 new stem cell lines with improved techniques. Scientists at
the University of California have shown that stem cells can be derived
without contamination from animal cells. And doctors in Israel have
developed stem cell lines that have genetic traits with the potential
of treating hereditary diseases, such as muscular dystrophy. These
astonishing breakthroughs could lead to new cures and new understanding
of these disorders, but the administration's restrictions bar NIH from
supporting research to explore their promise. To unlock the healing
power of stem cell research, the first action our legislation takes is
to end the ban that keeps NIH from supporting research on new stem cell
lines.
But science without ethics is like a ship without a compass. Strong
ethical guidelines are needed to ensure that scientific progress
follows the moral course that we as a society set. For this reason, the
second major action our legislation takes is to establish ethical
safeguards for stem cell research. And once again allowing NIH to lead
stem cell research, we bring more research under the strong ethical
standards that are part of every NIH grant for any kind of medical
research. The bedrock principles of these standards are informed
consent of the patient and approval of an ethics committee.
In addition, when it comes to stem cell research, our legislation
requires NIH to go beyond these general requirements and requires NIH
to issue specific standards for stem cell research. Before the NIH stem
cell research program was terminated in the early days of the Bush
administration, it had developed an extensive and robust ethical
framework for the research. These requirements include an extra level
of review to assure that all research was conducted according to
special protections applicable to stem cell research. They limit
research only to cells derived from embryos from fertility clinics that
were never to be used to initiate a pregnancy and were likely to be
discarded. They prohibit payment for donation of cells. They forbid
improper inducements to donate embryos to further ensure that all cells
used for research must come from embryos that would not be used to
initiate a pregnancy.
I want to take a moment to discuss this last point in detail. Even
with the intense debate on stem cells over the last 5 years, there
remains some confusion about the source of stem cells. The cells are
not derived from fetuses, they are not from embryos that might
otherwise have been used to start a pregnancy.
Our legislation explicitly requires the stem cells to be derived:
From human embryos that have been donated from in vitro
fertilization clinics, were created for the purpose of
fertility treatment, and were in excess of the clinical need
of the individuals seeking such treatment.
Those are the words, Mr. President.
In fertility clinics around the country, there are thousands of
embryos that are simply thrown away. Hundreds of thousands more are
frozen and never used. They are not the result of a pregnancy; they are
not the product of an abortion or a miscarriage. The only way they can
produce life is to be implanted in a woman, and these embryos we
propose to save for research have not been and will not be. We believe
it is better to save embryos that would otherwise be destroyed so they
can give the gift of life to patients who are suffering. Life is too
precious to allow an opportunity to cure illness to be simply thrown
away.
Some say this debate is only about science, and that it is not a
moral choice. I disagree. A vote on this bill involves a deeply moral
choice. It is a choice between making progress toward better treatment
for patients or spurning a chance for new cures. There are deeply moral
people on both sides of this debate, but I am convinced that medical
progress is the right one.
We have faced similar choices many times in the past. In the 1970s,
Congress was considering whether to ban research on recombinant DNA--
the very foundation of biotechnology. Then, as now, some raised ethical
concerns or dismissed the promise of this research as a pipedream, and
urged Congress to forbid it. In the 1980s, Congress made the right
choice by rejecting attempts to outlaw IVF, a technique that has
fulfilled the hopes and dreams of thousands of parents who never would
have been able to have a child otherwise.
Other forms of medical progress brought similar controversy:
transplantation, blood transfusion, even
[[Page S7604]]
vaccines. All of these breakthroughs were once new and controversial,
with strong voices raised against them. All were discussed and debated
and eventually adopted in ways that are consistent with American
values. Each time we looked to the future and saw the potential of
controversial research, we chose progress, and the benefits have been
immense.
We should make the same choice on stem cell research. We should not
allow the misplaced fears of today to deny patients the cures of
tomorrow.
Some argue that we should support research on adult stem cells, or
stem cells from umbilical cords, or stem cells derived from using new
genetic techniques. I agree. We should leave no stone unturned in the
search for new cures. Perhaps some cures will come from one technique
and other breakthroughs from another. Let's encourage our scientists to
explore every avenue that is ethical and could lead to progress. But
there is no sense in closing the door on one of the most promising
areas of medical research discovered in decades, while we wait for
other, less hopeful methods to show success or failure. That is not my
assessment; it is the judgment of every major scientific leader in
America.
According to a letter by 80 Nobel laureates:
For disorders that prove not to be treatable with adult
stem cells, impeding human pluripotent stem cell research
risks unnecessary delay for millions of patients who may die
or endure needless suffering while the effectiveness of adult
stem cells is evaluated.
The Institute of Medicine was just as clear on the need for embryonic
stem cell research:
Embryonic stem cells studied in animals clearly are capable
of developing into multiple tissues and capable of long-term
self-renewal in culture, features that have not yet been
demonstrated with many adult stem cells.
In a letter to the Senate Appropriations Committee, Dr. Elias
Zerhouni, the Director of the NIH, said:
It is clear that more cell lines would be helpful in
ensuring expeditious progress in this important field of
science.
His conclusions were echoed by other NIH Institute Directors such as
Dr. Elizabeth Nabel, head of the NIH Institute on Heart, Lung and Blood
Disorders, who said:
The limitations of existing cell lines are hindering
scientific progress among a community that is very eager to
move forward in this promising area.
The judgment of the Nation's scientific leaders could not be clearer
or more emphatic: Yes, we should study adult stem cells, but we should
let science decide which approach works best for patients.
But in the end, this debate is not about abstract principles or
complex terms of science. It is about people who look with hope to stem
cell research to help them with the challenges they face.
Two years ago, I held a forum in Boston on the promise of stem cell
research. One of the participants was Moira McCarthy Stanford from
Plymouth, MA, whose 14-year-old daughter Lauren has juvenile diabetes.
I wish to end my remarks today with a letter that Lauren wrote to me.
It explains far more eloquently than any Senator could the urgent need
to pass this legislation. These are Lauren's words:
For as long as I can remember, I have had to take a lot of
leaps of faith. I have had to believe my parents when they
told me taking four or five shots a day and pricking my
finger eight or more times a day was just a new kind of
normal. I had to--
The PRESIDING OFFICER. The Senator has 3\1/2\ minutes remaining.
Mr. KENNEDY. I thank the Presiding Officer.
I had to just smile and say I'm fine when a high blood
sugar or a low blood sugar forced me to the sidelines in a
big soccer game, or into the base lodge on a perfect ski day,
or out at the pool during a swim meet.
But when I watched, with my parents, President Bush's
decision on stem cell research in the summer of 2001, I just
could not accept it. You see, the one thing that has helped
me accept all I have had to accept these years is
the presence of hope. Hope keeps me going.
That night, President Bush talked about protecting the
innocent. I wondered then: What about me? I am truly innocent
in this situation. I did nothing to bring my diabetes on.
There is nothing I can do to make it any better. All I can do
is hope for a research breakthrough and keep living the
difficult, demanding life of a child with diabetes until the
breakthrough comes. How, I ask my parents, is it more
important to throw discarded embryos into the trash than it
is to let them be used to hopefully save my life.
I am so happy to hear that the Senate is thinking of
passing H.R. 810. I can dream again--dream of that great day
when I write a thank you letter to the Senate, to the House,
and everyone who helped me become just another girl; a girl
who dreamed and hoped and one day, got just what she wanted:
her health and her future. That's all I'm really asking for.
Those are Lauren's words, and they command us to act. Tomorrow, we
must cast a vote of conscience and of courage. We must reaffirm that
our common value of bringing hope to those who need it outweighs any
single ideology. We must approve the Stem Cell Research Enhancement
Act, and we must call upon the President of the United States not to
veto hope.
I thank the Chair.
Mr. REED. Mr. President, I believe I have 5 minutes under the order.
The PRESIDING OFFICER. The minority controls the time until 5:30.
Mr. REED. Mr. President, I yield myself 5 minutes.
I wish to take a few moments talking about H.R. 810, the Stem Cell
Research Enhancement Act. Last year, the House overwhelmingly passed
this bill, and I am pleased that the Senate will now finally consider
this legislation. My colleague in the other body, Congressman Jim
Langevin, has been a staunch advocate for stem cell research and has
played a central role in advancing this legislation through the House
of Representatives, and I commend him for that.
I hope to be able to stand on the Senate floor a few years from now
to highlight the advancements that have been made in the treatment of
spinal cord victims, children with diabetes, and Parkinson's treatment
because of embryonic stem cell research. However, I fear that even if
the Senate approves legislation, patients will only see further delays
in promising stem cell research.
The President endorsed the use of Federal funds research on existing
cell lines in his August 2001 Executive Order. At the time of the
announcement, he said:
Scientists believe further research using stem cells offers
great promise that could help improve the lives of those who
suffer from many terrible diseases--from juvenile diabetes to
Alzheimer's, from Parkinson's to spinal cord injuries. And
while scientists admit they are not yet certain, they believe
stem cells derived from embryos have unique potential.
This is from the President's Executive Order.
We know now that the stem cell lines identified in the Executive
Order were not the panacea for breakthrough medical research. There are
only 22 stem cell lines available for federally funded research, and
since they were derived in the absence of scientific and ethical
guidelines, they have proven unsuitable for most research. At the same
time, there are approximately 400,000 frozen embryos in IVF clinics
that will likely be destroyed. While I recognize the many benefits of
using embryonic stem cells in biomedical research, I also realize that
many serious ethical and moral issues have to be considered. I believe
Federal guidelines designed to create and uphold strict oversight of
these practices can achieve the appropriate balance needed in order to
ensure that this research is being carried out in an acceptable manner.
H.R. 810 sets forth responsible rules and limitations for obtaining
excess embryos as well as adequate standards for conducting research
involving embryonic stem cells. It would establish the necessary
framework for oversight so that principled research can finally be
allowed to proceed.
Some of my colleagues believe embryonic stem cell research is not
necessary, given some of the tremendous advances adult stem cells have
yielded. Indeed, I wholeheartedly support continued progress in the
area of adult stem cell research and was proud to be one of the lead
sponsors of the Stem Cell Therapeutic and Research Act, which Congress
enacted late last year. This bill was essential in maintaining patient
access to lifesaving treatments through the National Marrow Donor
program and also opening the door to the developments of a companion
registry system for cord blood.
We know the use of umbilical cord blood in treating diseases such as
leukemia, sickle cell anemia, and rare but deadly genetic disorders
such as Krabbe disease is showing tremendous promise. The Stem Cell
Therapeutic
[[Page S7605]]
and Research Act solidified the Nation's commitment to increasing the
number of cord blood transplants by providing additional Federal funds
to help public cord blood banks increase their inventory, as well as
support outreach, patient advocacy, and coordinating information and
education activities.
The President also recognized the importance of this avenue of
research. During the 2001 Executive Order, he said:
You should also know that stem cells can be derived from
sources other than embryos. And many scientists feel research
on these types of stem cells are also promising. Many
patients suffering from a range of diseases are already being
helped with treatment developed from adult stem cells.
He went on to add:
However, most scientists, at least today, believe that
research on embryonic stem cells offer the most promise
because these cells have the potential to develop from all of
the tissues of the body.
Those are the President's words. I urge all of us to heed those words
today.
I urge the Senate to support H.R. 810 and also the President to sign
it into law. I also intend to support S. 3504 and S. 2754, but neither
of these measures is a substitute for H.R. 810.
Mr. President, I yield the floor, and I note the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. ISAKSON. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. ISAKSON. Mr. President, I rise to take advantage of the time
assigned or allotted for all of us to discuss what is obviously a
passionate, controversial, and important issue. But I rise to talk
about it from, probably, a different perspective than some of the other
speeches--at least those I have heard. I want to talk prospectively,
about what happens after this debate is over.
If all the predictions come true, at the end of the day we will not
debate stem cells for the rest of this year because the agreement to
bring it to the floor was that we come to the floor, we debate these
three bills, and the debate would be over for the year.
The debate will not be over. In fact, if anything, this is probably
the beginning of a long debate as we deal with the ethics and the
morality and the hope and the promise of science as it relates to stem
cells--in particular, embryonic stem cells.
When the President issued his order in August of 2001, I supported it
because it invested in embryonic stem cell research and it clearly drew
the line in terms of how far we would go. I have been supportive of the
President's policies on embryonic stem cell research since.
When H.R. 810 passed, I began to do what I think all of us should do.
I began to get educated as best I could on this controversial and
important issue. Dr. Michael Johns at Emory University helped me. Dr.
Steven Stice, at the University of Georgia, helped me. I sat through
more than a few demonstrations--not sales presentations but
demonstrations of programs and efforts in embryonic stem cell research
underway, under NIH guidelines, and were moving forward.
I learned a lot. I learned this promise of embryonic stem cells was
uncovered or identified in 1998. Research has been done for 8 years.
They hold great promise. Adult stem cells have been around longer and
have demonstrated promise beyond what embryonic has today, but that is
because of the time and the amount of money that has been invested.
But I learned one thing. I am not smart enough to know what the end
result of all this research will be, but I am smart enough to know that
our country must continue to be a player in the research. Everywhere
NIH is involved, you have standards, you have ethics, you have
procedures, and you have protocols. It is very important that all those
exist in such a delicate and important type of research. We must be
respectful of human life.
The proposal in H.R. 810 that is of concern is that it involves the
destruction of an embryo that, if implanted, could become a human
being. That is a legitimate concern for us as a country to have.
When Senator Frist began fielding inquiries with regard to this
issue, months ago, after H.R. 810 passed the House, I engaged myself as
I was in this learning process in hopes of finding a prospect where we
could match the standards of ethics we all want and also invest in the
hope for the future. I believed that there was a way--in fact, there is
a way--that we could invest in embryonic stem cell research without
involving the destruction of an embryo that could be transferable to
the womb and become a fetus.
For a second, I wish to discuss that on the floor simply, if nothing
else, to point out that there are many opportunities of hope out there
that meet both the ethical and the moral as well as the scientific
desire that I think a consensus of this body has.
Dr. Steven Stice is a noted researcher at the University of Georgia.
I had the privilege of meeting him last year. I have three times been
to his clinic at the university. Dr. Steven Stice is a man who
understands the concern over the ethics of the destruction of a viable
embryo. So in the development of embryonic lines BG01, 2, and 3, which
were developed prior to August of 2001 and are in operation at the
University of Georgia today, those stem cell lines were derived from
the byproducts of in vitro fertilization that could not be implanted
and could not be frozen.
My point to you, the Presiding Officer, and the ladies and gentlemen
of the Senate, is this: There are three lines that exist today that
were derived from the byproducts of in vitro fertilization that could
not be implanted in the womb and become a fetus or be frozen for
subsequent implantation. Under the Guarder et al. principles in the
grading of material in in vitro fertilization, there is a clear line of
that which is viable, that which can be frozen, and that which cannot.
It doesn't involve the discarding of anything that can be viable, but
it does lend hope that from sources other than the viable embryos, stem
cells can be derived.
I respect human life and I want us, as a nation, to always be
respectful and never disrespectful of it and its potential. I also
respect the wonder of science in innovation and the great discoveries
that it has brought. I stand here today believing that you can do both
and that as we move forward, beyond this debate, beyond a veto if it
takes place--whatever the fire and substance is--we should start
tomorrow looking at these other alternatives. Just in the 18 months
since this issue began to bubble up in the Senate, there have been
breakthroughs, such as single cell extraction from embryos without the
destruction of the embryo--something that holds great promise for those
cells to actually replicate themselves into stem cells.
We can do it. It is important that we stay on course to do it. But it
is important that we not break the ethical principles to which we are
committed and always be respectful of life.
In the course of the negotiations with the leader--and I want to
inject something here with regard to Majority Leader Frist. I don't
know anybody who has ever been dealt a tougher hand in terms of coming
to a resolution of these issues. I thank him for the amount of input he
let me have. Unfortunately, I was unsuccessful in being a part of the
final debate, in terms of what I just described, in terms of the stem
cell lines they are operating on at the University of Georgia, but I
think under the circumstances he did the best he could.
Sincerely I stand here as a Member of the Senate with 4 years
remaining in my term, knowing that we will revisit this issue time and
again. As science changes and moves forward, there will be ways we can
embrace, ethically and rightfully, research that holds hope and promise
for those who suffer and those who are afflicted.
My last comment is this. I was a real estate broker in my private
life, before I came to Congress. I am not a doctor and I am not a
scientist. I have heard some declaratory statements on the floor about
what research will and will not prove in the future. I didn't just fall
off a turnip truck. You do research to determine what you are going to
find out, not just to predict what it will or will not do.
As we go through this difficult, tenuous debate over a subject of
immense
[[Page S7606]]
importance to the American people, let's look for ways that we can be
respectful of human life and open the doors for the furtherance of
development in science in embryonic stem cells. I submit there are ways
to do both, and I will be here to work with the leader, with my
colleagues, and with our President to unlock those doors so that
promise and hope exists and we never breach the ethical divide that
caused the debate today.
I yield the remainder of my time and suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. BROWNBACK. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. BROWNBACK. Mr. President, I see the next speaker is here, and I
yield the floor.
The PRESIDING OFFICER. The Senator from Maine is recognized.
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 tireless efforts to ensure consideration of stem cell legislation.
The bottom line is, there is research we could 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 have cosponsored H.R. 810, the Stem Cell Research
Enhancement Act.
The promise of stem cell legislation 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 many future therapy because in so many diseases, cells are lost and
their function is often irreplaceable. Stem cells offer an opportunity
to actually replace cells which are lost.
Consider today that 20 million Americans live with diabetes. Despite
treatment with drugs and insulin, many 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 even a therapy to replace the
function of lost cells. Brain disorders such as Parkinson's disease,
ALS or ``Lou Gehrig's disease,'' and Alzheimer's disease have only
limited treatment options available. We simply cannot replace the
function which is lost. But with new therapies derived from stem cells,
we could see major breakthroughs in avoiding the terrible toll that
millions now experience.
Today the Senate is considering three bills. The first of these, the
Fetus Farming Prohibition Act, certainly addresses an issue about which
I expect there is no disagreement in the Senate. No embryo should ever
be conceived for the purpose of producing stem cells. That is not at
issue. Nor does any reputable scientist desire to work with human
tissue produced in an animal. These prohibitions are not controversial
and I believe my colleagues will join me in supporting them.
In fact, 1 year ago this week, I joined with Senators Feinstein,
Specter, Hatch, and others to introduce the Human Cloning Ban Act to
make indisputably clear another prohibition--that no human would be
cloned. Nor is stem cell research about conducting research on embryos.
I do share with the majority leader the concern that we address the
highest levels of ethical standards, and I have great confidence that
with the Federal Government playing a role in this research, we can
bring such standards to bear.
This is essential--that the Federal Government be constructively
engaged.
The second piece of legislation concerns stem cell research already
supported by the Federal Government. My colleague, Senator Santorum,
has introduced legislation--the Alternative Pluripotent Stem Cell
Therapies Enhancement Act, S. 2754--to promote the use of ``alternative
stem cells.'' These are typically ``adult stem cells.'' These cells are
already partly specialized, and have the potential to develop into
several kinds of cells. Yet they are not the same as embryonic stem
cells, which can develop into potentially any kind of tissue. So their
use is limited. Cord blood stem cells are an example of this type of
cell, and they have certainly proven useful in treating some diseases.
I must note that no obstacles currently exist to the kind of research
the Santorum bill addresses. Clearly, adult stem cells have potential,
and certainly research on them should continue to be pursued. Yet by
passing this bill we do not open any new avenues to our scientists. In
fact, we can make them take a detour. This is why.
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 could not use them to produce many of the types of cells we need to
produce new therapies. Essentially, one would have 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 the
way to get where you are going.
So while adult stem cells have promise--they certainly are not
comparable to an embryonic cell--with its potential to become any type
of cell in the body. And even if you could turn an adult stem cell into
an embryonic stem cell--you have simply doubled the obstacles and work
required to reach your destination--which is a cure. That means
millions of lives lost as you pursue a convoluted course. . . .when
embryonic stem cells provide a far more direct path to creating cures.
That is why I am a sponsor of the Stem Cell Research Enhancement
Act--H.R. 810--the third bill on which we will vote. Remember that we
shared hope for progress back in August of 2001 when the President
declared research could utilize the stem cell lines then in existence.
Yet scientists have found that many of the cells were contaminated or
otherwise unusable. In part we know that even when a stem cell line is
created, it cannot reproduce indefinitely. So we must address how we
may obtain additional cell lines for medical research.
I thank Senators Specter and Harkin, and Representatives Castle and
DeGette for joining together to work to address the fundamental
question of federal participation in embryonic stem cell research. The
legislation which they produced 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. The act
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
[[Page S7607]]
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. More than 70 percent of the American
people 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 the Senate version of
this legislation introduced by Senators Specter and Harkin. 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. Hopefully he will not veto this
legislation because ultimately the alternative is to accept the status
quo. The status quo is not right for those suffering from these
diseases and for future generations who will.
I think back to President Reagan's passing 2 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 H.R. 810 does, and that is
why we must send this bill to the President and he must sign it.
The PRESIDING OFFICER. The Senator from Kansas is recognized.
Mr. BROWNBACK. Mr. President, how much time remains on our side?
The PRESIDING OFFICER. There is 8 minutes 30 seconds.
Mr. BROWNBACK. Thank you very much.
I want to point out in a little different format to my colleagues
that when we talk about direct areas of being able to get treatments--
we covered this some today--this is a little bit of a different
presentation and a little more directly related to where we are getting
treatments in this field, which is in the adult stem cell field. Here
are some of the various areas where we get direct treatments.
The area of embryonic research, while interesting and intriguing, is
not producing any results. It is not producing any cures. We are
getting direct results from the adult, and we are not getting the
formation of tumors in the adults. This area is working.
I also point out this is at no cost. People say these are embryos and
we are throwing them away. You look at that. And I had this morning in
my office and at a press conference three snowflake babies. These are
all babies who were in in vitro fertilization clinics, were not going
to be implanted by the natural parents, were given up for adoption.
They are here now, and they are beautiful and they are wonderful. They
are absolutely precious.
This isn't some sort of throwaway commodity. I point out to people
that if you are one of those individuals who have frozen embryos--the
number I hear is that 1 in 10 people in the United States suffer from
infertility problems. There are a lot of people who would want to and
do want to implant these frozen embryos and give them the nurturing
they need to become humans we would all recognize. I hope people will
look at that.
My other point is on President Reagan, who certainly was an
inspiration for me to get into public office, and had a beautiful
winsomeness about his presentation of truth. He was a fabulous
individual. President Reagan was pro life. President Reagan did not and
would not agree with the destruction of young human life. In fact, he
said at one point in time, if there is a doubt about whether it is a
life, if somebody was dying and there was a doubt about whether they
are dead, you wouldn't put them in a casket and bury them. You would
give them the benefit of the doubt. You would say, Well, let us work to
bring them back.
The same on the young end--if there is a question, you err on the
side of life. You treat this as life. There is a kind of common sense
about it.
President Reagan was pro life. He fought for pro-life issues. He
would not want to see us destroy one human life for the benefit of
another.
A final point in this area: President Reagan suffered Alzheimer's
disease. Alzheimer's is, as I understand it being explained to me, a
plaque disease on the brain material. It is highly unlikely it is going
to be treated with stem cells. Parkinson's is an area where we have
adult stem cell treatment--a different type of disease. But the disease
President Reagan fell to was Alzheimer's. It is highly unlikely that
any stem cell, even adult or cord blood, and even more unlikely
embryonic or cloning, would deal with the area of Alzheimer's.
The only reason I mention that is I think we need to try to be very
accurate in our debate in saying what is a good possibility and hope
and what is not. That one would be unlikely. Parkinson's we have a good
shot at in the adult stem cell, and we have some early treatments
already showing some promise in that particular field. But I don't
think it is wise that we bring that up in that particular instance in
the case of Alzheimer's. I think it is important that we be very clear
about what this is and what will work and what will not.
The other thing I want to make mention of when we are talking about
cures for things in this field is let us talk about areas where we have
real scientific prospects of getting this done in the adult field. In
the embryonic, as we have said for some period of time, it is unlikely
to produce any sort of direct benefit to patients any time in the near
future. That is according to scientists who are pro embryonic stem cell
research. We can do more research in this field. There is some
understanding from the presentation of the Senator from Georgia talking
about other areas to derive embryonic type of stem cells. That is
something we can do. The scientific community is producing more and
more results in that particular area which I think are quite helpful
and quite promising for us. It removes the ethical dilemma on this. It
would be deriving embryonic type stem cells but without destroying
embryos.
We are coming up with this along with the stem cell line. People are
coming up with this in other fields. There is no reason to go into the
ethical area--the question of destroying human life with taxpayer
dollars to be able to get that done. I think it is important that we
point out those particular areas in this bioethical debate.
One of the bills we will be voting on is an alternative bill. I
talked about the fetal farming bill. I hope that passes 100 to zero so
we can ban fetal farming. A lot has been talked about on H.R. 810,
which is expansion of the stem cell lines using embryos and Federal
taxpayer dollars to do that.
What has been talked about less is this area of the Santorum-Specter
bill which would create embryonic type stem cells without destroying
embryos. Here is a way for people, if they are troubled about the
ethics of destroying a young human--I really do not want to do that,
but you think there is a promising area of inquiry on these embryonic
type stem cells and you are looking at this saying, Yes, it is not
producing cures or results right now, but it might in a decade or two,
so I would like to see this pursued--here is an ethical alternative for
you to pursue. You don't have to say, Let's destroy this young human
life. You can
[[Page S7608]]
say, Let us go with the alternative here where we are finding
scientifically that we can derive these types of stem cells without the
destruction of human life, embryos. If you like this field of inquiry,
I raise a question about embryonic stem cells because we have invested
$.5 billion in animal and human. We don't have any applications for it
today, but if you are still saying we still ought to invest in this
field because it might produce something, it might produce something
big, you have an alternative which you can vote for in this Santorum-
Specter alternative bill, and say, We want to pursue the science in
this particular field. That is an area and a possibility that could
work and we can and should, I think, pursue. I think it would be a good
alternative for somebody who is in that type of quandary about which
way to pursue this.
I will have further comments later on this evening. I don't want to
take up the other side's time. I yield the floor. I suggest the absence
of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER (Mr. Isakson). Without objection, it is so
ordered.
Mr. HARKIN. Mr. President, we are awaiting the arrival of a Senator
on our side to speak on the stem cell issues. Until that happens, I
will take a couple of minutes to talk about something my friend from
Kansas brought up earlier today about adult stem cell treatments.
I am reading a letter from Scienceexpress, a publication of Science
magazine. It is entitled, ``Adult Stem Cell Treatments for Diseases?''
Opponents of research with embryonic stem (ES) cells often
claim that adult stem cells provide treatments for 65 human
illnesses. The apparent origin of those claims is a list
created by David A. prentice, an employee of the Family
Research Council who advises U.S. Senator Sam Brownback (R-
KS) and other opponents of ES cell research.
Prentice has said, ``Adult stem cells have now helped
patients with at least 65 different human diseases. It's real
help for real patients''. On 4 May, Senator Brownback stated,
``I ask unanimous consent to have printed in the Record the
listing of 69 different human illnesses being treated by
adult and cord blood stem cells''.
In fact, adult stem cell treatments fully tested in all
required phases of clinical trials and approved by the U.S.
Food and Drug Administration are available to treat only nine
of the conditions on the Prentice list, not 65.
Again, it exposed most of these as kind of being bogus. One of those
listed was testicular cancer. Testicular cancer is not being treated
with adult stem cells, at least not successfully. In fact, according to
the Sciencexpress article, the study that is supposed to be the basis
for that claim is actually a study on how to isolate adult stem cells.
The Senator from Kansas also has a list that included several
leukemias and lymphomas. Let's hear what George Dahlman of the Leukemia
and Lymphoma Society has to say about that.
On behalf of the Leukemia & Lymphoma Society, I am writing
in response to assertions that adult stem cells have treated
or cured several blood cancers, including several leukemias,
lymphomas and multiple myeloma.
As a representative of more than 700,000 patients and their
caregivers in this country that battle blood cancers on a
daily basis, our organization would like to emphasize as the
Senate debates H.R. 810, the Stem Cell Research and
Enhancement Act, that we exist today because we have not
found cures for these devastating diseases. Furthermore, the
claim that treatment of blood cancers with cord blood, blood
or marrow stem cells--known as hematopoietic stem cells--
demonstrates the potential of `adult stem cell' research or
is a substitute for embryonic stem cell research is
misleading and disingenuous.
Mr. Dahlman concludes:
The Leukemia & Lymphoma Society asks that you and your
colleagues pass H.R. 810, and not accept any substitutes.
All in all, according to the science journal, only nine diseases of
the 65 examined have proved to even respond to treatment with adult
stem cells.
The authors of the analysis conclude that claims about stem cells
being in general use for 65 diseases are false. Such claims ``mislead
lay people and cruelly deceive patients.''
Again, we are going to hear a lot of talk about all we can do other
than embryonic stem cell research. This should not be a debate about
whether we do adult stem cells, cord blood, or all these other things.
They are all worthy of research.
Those that are for adult stem cell research, cord blood, bone marrow
research, that type of thing, all say they want to do that to the
exclusion of embryonic stem cells. Those who are in support of H.R. 810
say let's do them all and do them all in an ethically acceptable
manner.
Again, we have strong ethical guidelines. One, we do not create any
embryos with this bill. You can only use the embryos that are already
existing in IVF clinics that are left over that will be discarded.
Second, we must have written informed consent of the donors. Third, no
one can get paid; no money can change hands. You cannot entice someone
to donate these embryos with money. We have strong ethical guidelines.
Lastly, I have heard comments today time and time again about how
this bill, H.R. 810, involves the destruction of embryos. I challenge
anyone to show me where in H.R. 810 it provides for the destruction of
any embryos. Under the Dickey-Wicker amendment that is now existing, no
Federal funds can be used to destroy embryos. All H.R. 8l0 says is that
once stem cells are derived through private means or whatever, then
Federal funds can be used to go to universities or to other researchers
to study these embryonic stem cells.
There is nothing in this bill, and I challenge anyone to show me in
H.R. 810 where it provides for the destruction of any embryos; it does
not. To say otherwise is being disingenuous. The Dickey-Wicker
amendment still applies. No Federal money can be used for the
destruction of embryos, plain and simple.
I see my colleague from Illinois is here. I yield the floor.
Mr. DURBIN. I thank the Senator from Iowa not only for yielding but
also for being the leader on our side of the aisle on this issue, with
Senator Specter on the Republican side. I am glad this day has finally
come. This matter has been on the calendar for over a year.
For over a year, millions of Americans have been wondering when the
Senate will take this up. Finally, it has been scheduled. A lot of
people outside this Chamber had a lot to do with it being scheduled.
First Lady Nancy Reagan stood up and spoke up when she saw the late
President suffering from Alzheimer's. Her voice has made a difference.
I salute her for that. Christopher and Dana Reeve, both gone now, in
their lifetime, the dedication and energy they put on this issue made
all the difference in the world.
There are three votes tomorrow. There is only one that gets to the
heart of the issue. There are some that are going to address a lot of
different issues from different perspectives, but there is only one
that counts when it comes to stem cell research. The Stem Cell Research
Enhancement Act is the only bill that expands Federal funding for
embryonic stem cell research, the type that holds out so much promise.
The other two bills are well intentioned. I am not going to say
anything negative about them. I will vote for them because, frankly,
they make little or no difference. One of them bans practices that
presently are not being used. I guess that is a good thing to do. I
will vote for that bill.
The other one, by Senator Santorum of Pennsylvania, won't accomplish
much. This was the question I asked of Dr. James Battey of the National
Institutes of Health about the Santorum bill: Can you tell me whether
S. 2754 authorizes research on stem cells at the NIH that currently is
not permissible or legal?
He answered: No, it does not.
So it does not give new authority to NIH, and it does not expand
research. It has some motive other than medical for being offered.
William Neaves, a leading stem cell researcher, has it right:
This is not a contest between adult stem cells and
embryonic stem cells. Instead, it is a contest between
society and disease.
I have listened to some of the arguments in the Senate. Some of the
arguments are that adult stem cell research has great potential. I
believe that is true. I believe we should pursue it aggressively.
However, the argument seems to be that if that is the case,
[[Page S7609]]
then we do not have to concern ourselves with embryonic stem cell
research.
I am a liberal arts lawyer and do not profess to know about medical
research, but why foreclose a whole area of research with embryonic
stem cells that the greatest minds in America tell us is so promising?
Why wouldn't we do both, both adult stem cell research, as well as
embryonic stem cell research? From that point of view, I cannot follow
the logic in opposing this bill.
Former Senator John Danforth is another person who has thought about
this issue. I respect him a lot. He is an ordained Episcopal minister
and a longtime opponent of abortion. Like tens of millions of
Americans, he comes from a family that knows the pain of disease. He
lost one of his brothers to Lou Gehrig's disease. He wrote this in the
St. Louis-Post Dispatch:
A choice between two understandings of human life. On one
hand, we have millions of people who suffer from ALS,
Alzheimer's, juvenile diabetes, Parkinson's, spinal cord
injuries and cancer--and the loved ones who care for them and
suffer by their sides. On the other hand, we have tiny
bundles of unfertilized cells existing in petri dishes.
He went on to write, the people who oppose stem cell research:
should explain to the afflicted and their loved ones why
they care more about those cell bundles than they do about
the people.
This Stem Cell Research Enhancement Act has been supported by so many
groups. I ask unanimous consent, Mr. President, to have the names of
some of those groups printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Who Supports H.R. 810
The Stem Cell Research Enhancement Act is supported by more
than 200 patient groups, scientists and medical research
groups. They include: American Medical Association, American
Association for Cancer, American Diabetes Association,
Juvenile Diabetes Foundation, American Pediatric Society,
March of Dimes, the ALS Association, Parkinsons Action
Network, Alzheimer's Association, Parent Project Muscular
Dystrophy, Kidney Cancer Association, Coalition for Pulmonary
Fibrosis, and the Society for Neuroscience Research.
Mr. DURBIN. I would say that all of the big names in medical research
in America support this bill. They understand this is the real deal.
This is the bill that will make a difference. The other two may not.
Among the other groups supporting the Stem Cell Research Enhancement
Act are the Republican Main Street Partnership, the B'nai B'rith
International, and a long list of people representing religious
organizations from almost every denomination in America.
Why do we need this? We need it because President Bush decided in
2001 to take a position on medical research. I do not think there is a
precedent in American history for what he did. He basically said we
were going to cut off Federal funding for those who were involved in
embryonic stem cell research, except for a limited number of lines. He
identified 78 stem cell lines on the day of his speech and said that
scientists who received any Federal funding at all could work only on
those stem cell lines.
As Senator Harkin has pointed out over and over, not only were the 78
lines reduced to 22, they are all contaminated. They cannot be used for
this research anymore. So President Bush is not offering any hope when
it comes to this area of research. I do not want to get into the moral
argument here because it is almost religious. It is moral and
theological here. But if the President could rationalize 78 stem cell
lines as being appropriate and all right for research, then he has
fundamentally decided the research is permissible, I suppose. I do not
follow his logic. And I do not follow the logic of some who oppose it
who say that because this is a product of in vitro fertilization and
has the potential for life that we should not do research. We know that
in that process, some of these fertilized eggs will end up being
implanted in the womb of an expectant mother in the hope she becomes
pregnant, and others will not be used. It is the nature of the process.
They make more of these fertilized eggs than they will need in the
hopes that one will work.
Then what happens to the rest? Well, they are going to be discarded.
They are not used to find cures for diseases. But for those who find it
immoral to use the product of that process for medical research, I
still am troubled by the notion that they have not come to the floor
asking that we ban in vitro fertilization, because we know that is a
natural consequence of this process. And if it is permissible and moral
and legal to have a process which results in these extra cells, I do
not understand the moral question about using these fertilized cells to
give people a chance to live and to live their lives better. I just do
not understand that.
To measure the impact of President Bush's policy, Stanford University
looked at peer-reviewed research published in scientific journals. They
found that embryonic stem cell research in the United States made up
one-third of the papers published in 2002 but only a fourth of those
published in 2004. Research is slowing down. President Bush's decision
is reducing the number of opportunities for embryonic stem cell
research.
The world's best and most respected scientists--our own NIH
leadership--tell us that this area of scientific research could lead to
treatments and cures. Dr. James Battey chairs the NIH working group on
stem cells. This is what he said before the Senate Labor, HHS
Subcommittee:
There's no scientist that I know who would argue that more
stem cell lines wouldn't accelerate the pace of scientific
research. . . . Cell lines offer scientific opportunities
that are right now beyond the reach of federal funds.
Other things have changed since President Bush's decision in 2001 as
well. We have learned more about the potential of stem cell research.
Dr. John Kessler is the chair of the neurology department at
Northwestern University Medical School in Chicago, which I am honored
to represent. He is also the father of a 20-year-old daughter who is
paralyzed as a result of a spinal cord injury. He told me personally
that he finds the current administration policy ``unconscionable'' in
light of everything we have learned since 2001.
H.R. 810--the real bill, the one that is important, and the one that
will make the difference--would loosen the handcuffs on America's
scientists. It would allow scientists to receive Federal funding to use
embryonic stem cell lines in their research if--and only if--two very
specific conditions are met. First, the stem cell lines must be derived
from eggs that were produced for in vitro fertilization but are going
to be discarded. The choice is research or destruction of these
potential means of creating medical opportunities. Second, both adults
to whom the eggs belong must provide written consent that the eggs be
donated to science.
It is estimated 400,000 excess eggs are being stored now in clinics
around the country, stored in petri dishes at 300 degrees below zero.
Opponents of this research say it is unethical to use them for
research. But if they are not used, they will be destroyed. How in the
world can that be the right ethical, moral choice to destroy the
opportunity for research to cure disease?
I see my colleague from Washington is here, and I know she wants to
speak. I will close by saying this: I have met some of the children who
are victims of juvenile diabetes. I guess it comes home personally when
you sit down with these kids and their mothers, and the mothers say: I
wake my daughter up twice in the midst of the night to take a blood
test to see how she is doing. Think about that for that poor little
girl being awakened twice each night. And think about the mother and
her worries that that little girl, who she loves so much, may go blind
or lose a limb or die. And think about the hope they have in their
hearts that this research will go forward.
I have met the victims of ALS and diabetes and Parkinson's and
Alzheimer's. I know they are praying we do the right thing tomorrow. I
hope we pass this bill. I am not certain it will pass, but I am hopeful
it will. It will have strong support on this side of the aisle, and I
hope there will be enough votes on both sides of the aisle to enact it.
Then the bill will go to President Bush, and he will have a moment in
the history of this country to make a momentous decision. If he decides
to go forward and veto the stem cell research bill, it will be the
first veto of the Bush Presidency.
[[Page S7610]]
President Bush described himself politically when he ran for office
as a compassionate conservative. His decision on the future of this
bill will be the test of his compassion. If he has compassion for those
who are suffering across America, who are praying for the hope this
research can bring, I hope he will pray over his decision long and
hard. And if we pass this bill, I hope he will sign it and give these
Americans a chance for a better tomorrow.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Washington.
Ms. CANTWELL. Mr. President, I join my colleagues on the floor to
speak about H.R. 810. I applaud the Senator from Illinois for his
comments because I know he has many fine research institutions in his
State and has met with many people who suffer from a variety of
diseases who could be helped if H.R. 810 is passed and signed by the
President. So I commend him for his remarks.
I certainly thank the Senator from Iowa for being out here all
afternoon talking about the importance of this legislation and trying
to communicate how important it is that H.R. 810, the legislation that
focuses on embryonic stem cell research, be passed and signed by the
President.
I also want to say I know the Senator from Kansas has been out here,
and I have enjoyed working with him on a variety of pieces of
legislation, particularly legislation that dealt with international
marriage brokers, trying to protect women who come to America, making
sure they got full information about people who were helping them apply
for visas before they come to the country. So I certainly have enjoyed
working with the Senator from Kansas on other legislation.
But I wish to say I think it is important we focus our debate on H.R.
810--an important bill on embryonic stem cell research--in the context
of science, because I believe Congress must not stand in the way of
science. I think tomorrow's vote is exactly what that is about. So I
want to be clear that I support that legislation and will work to
overturn any attempts to veto this legislation.
Like my colleagues, I have met these Americans who for too long have
wanted to have hope. They have waited to have real hope that there
would be a lifesaving stem cell research program. Many Americans
believe we can do better. We know there are 3 million Americans who
need help, and we understand that by investing today we can save lives
tomorrow. We understand, for Americans who suffer from Alzheimer's or
ALS or Parkinson's disease, it really does mean hope and a new way of
looking at opportunity for them.
We will have a debate about this continuing today and tomorrow. But
we need to keep in mind it is good science that is at question. For us
in Washington State, with 35,000 Washingtonians living with Parkinson's
disease today, understanding what embryonic stem cell research can do
for them is of utmost importance.
We also have 300,000 Washingtonians who have been diagnosed with
diabetes who, obviously, are very interested in this legislation. We
have 160,000 Washington State residents who struggle with heart failure
and understand there is so much that could be done in this particular
area of research. We have 5,000 Washingtonians who suffer from spinal
cord injuries. So there are people all over our State with various
medical challenges who are looking to us to make the right decision and
to allow critical research to give them promise for opportunity in the
future.
At the Fred Hutchinson Cancer Research Center--I know my colleague
from Iowa has visited the Fred Hutchinson Research Center--they are
applying groundbreaking science and using adult stem cells to treat
blood cancers such as leukemia, lymphoma, and various other diseases.
They are also looking to do the same for kidney cancers.
The Benaroya Research Institute at Virginia Mason in Seattle is
working with stem cells on a collaborative 5-year project to grow a
living heart. The effort could lead to tissue-engineered replacement
hearts, and it means that could help us with various challenges in that
particular area of health care.
The University of Washington, which is in Seattle, boasts 70
scientists involved in aspects of stem cell biology addressing
everything from liver disease to coronary heart disease. Three years
ago, the NIH named the University of Washington one of the three
exemplary centers for human embryonic stem cell research. But in the
last 5 years, since President Bush banned the funding for embryonic
stem cell research, it is as though our Nation has turned its back on
that science and that work that could be done, and I am sure not just
in Washington State. But that is a representative example of what could
be done if we moved forward.
It is important we continue to move forward by passing H.R. 810. The
truth is that right now adult stem cells do not have anywhere near the
scientific potential as embryonic stem cells. Their application is
limited. Their reach is finite. And we do have a better option.
Allowing federally funded research on embryos that would otherwise be
destroyed would provide a much-needed expansion. Everything from
eradicating, in our past, polio to mapping the human genome, our Nation
has been a leader and an innovator in science and medicine. So let's
not fall behind now. Just as we are challenged with so many of these
diseases, we need to do more.
Of the original 78 stem cell lines the administration permitted
scientists to work on, only 21 are available today. Lab scientists must
turn to private investors and already struggling State governments to
carry on this critical research. So researchers in my State, in the
State of Washington, say that Federal funding would increase research
opportunities and allow scientists to use that money much more
effectively.
In March of 2006, the University of Washington announced that because
of Federal funding restrictions, it would seek to establish a stem cell
institute with private money and, instead, looks to raise $100 million
in private funds to help it move forward. The University of Washington
plans to reflect the intense competition it faces from other
universities around the country that are boosting their research into
stem cells which have permitted them to treat a variety of diseases. So
the competition will continue. But we could be working together in a
much more collaborative fashion, in a way that would help us extend the
scope of that research.
It is very important because so many of those involved in this
particular area believe passionately we need this new area of
expansion. One of those individuals, Dr. Storb of the Fred Hutchinson
Cancer Research Center in Seattle, recently said this:
We have exhausted research on adult stem cells. They do not
do the trick. We have worked with them for 30 years now and
know that they do not make all of the tissues in the body.
He further went on to say:
If the public wants cell-based therapies, then we must
conduct that kind of stem cell research. We may learn more
from embryonic cells how to program adult cells, but we have
to work with embryonic cells to do just that.
So this Congress, I believe, must not stand in the way of science. We
have three bills we will vote on tomorrow, but only H.R. 810 actually
clears the way for critical research that could lead to cures for so
many debilitating diseases.
There is no viable alternative to improving the research and serious
investments that I believe H.R. 810 will provide. When we are talking
to Americans who suffer from diseases such as Alzheimer's, Parkinson's,
and others, I think it is important, as my colleague from Illinois
stated, that we must keep in mind the stories of individuals.
Mr. President, one such individual is a 4-year-old who died of brain
cancer. Her mother wrote to us saying how important this bill was in
holding opportunities for other people in other families who suffer
from brain cancer. To me, it is so important that we pass this
legislation and help those individuals and families who are suffering
by giving them hope for promising research that we know science can
provide.
I yield the floor.
The PRESIDING OFFICER. The Senator from Iowa is recognized.
Mr. GRASSLEY. Mr. President, today, as everybody is doing, I want to
discuss the three stem-cell-research-related bills before the Senate. I
have been in the Senate for 26 years now. Every day, we make decisions
that impact Americans. It becomes difficult,
[[Page S7611]]
however, when we debate bills that involve the lives of women and
families, especially those who are sick and dying. We must be cognizant
of their plights, but we cannot forget about those who don't have a
voice.
Tomorrow, I will vote in favor of those who are not yet brought into
this world. I will vote for those who don't have a chance to speak
against legislation that doesn't give them a chance at life.
First, I intend to support S. 3504, the ban on fetus farming. This
bill states that a person cannot solicit or knowingly acquire, receive,
or accept a donation of fetal tissue or an embryo if the pregnancy was
initiated to provide such material. This bill will reduce the
likelihood that women will be used solely for their production of
embryos. We have to draw the line, and we have to prevent the
corruption that could occur.
Second, I intend to support a bill numbered S. 2754, which directs
the National Institutes of Health to fund alternative techniques for
stem cell research. It will allow researchers to use different
techniques to derive pluripotent stem cells without destroying human
life. This research could be done under current law, but a vote in
support of this bill will send a signal to the NIH that we want to see
even more of this research.
Finally, I will oppose H.R. 810 because it would expand Federal
funding for embryonic stem cell research.
Some of my colleagues will characterize the bill, H.R. 810, as a
lifesaving opportunity for many people with diseases. The focus will be
on promises, hopes, and dreams. This focus disregards that this bill
will allow researchers to use and abuse embryos. And there are enormous
moral and ethical consequences associated with that research.
You cannot mess with the facts. An embryo is life. No Senator can
disagree with that assertion. Once you realize that fact--that an
embryo is life--you have to realize that this bill takes life and plays
with it.
In addition, this bill doesn't prohibit cloning. In fact, it will
make cloning even more attractive. Why would we want to go down this
road of unethical research when we have a method that already works?
We all know that adult stem cell research has proven effective. We
are investing the taxpayers' money in research that benefits the
American people. We in Congress have to realize that there is a
difference between hope and hype. I, for one, will not be misled.
Adult stem cells have already proven effective for over 72
treatments. I will not list them all, but some of them relate to adult
stem cells being used to treat brain tumors, multiple sclerosis,
arthritis, and Parkinson's disease. Peripheral blood stem cells have
treated testicular cancer, lymphoma, and breast cancer. Cord blood stem
cells have treated leukemia. Olfactory stem cells from the nose can
develop into heart cells, liver cells, kidney cells, muscle cells,
brain cells, and nerve cells. Bone marrow stem cells and stem cells
from fat have the ability to differentiate and form other body tissues.
I wish I could list the advances with embryonic stem cell research,
but I cannot; there are none. There are no treatments for human
patients. So there is no evidence on which to argue that this research
should be expanded with public resources.
I have a story about a person that I have known for 44 years, David
Foege. I have known him since he was a page at the Iowa State
Legislature back in 1962. He is originally from Waverly, IA, so even
though he lives in Florida, I still consider him a constituent. There
is evidence, then, through Dave Foege that we should continue
supporting adult stem cell research.
Just 2 weeks ago, I had an opportunity to meet with David, who is now
61 years old and living in Florida. This is the story he told to me.
David was given a life sentence because of heart failure. Three years
ago, David was told that he had little chance of surviving. His heart
was losing all function and there was little that doctors could do.
David then turned to stem cell therapy. He found doctors in Bangkok
that would harvest his own stem cells and then inject them back into
his own heart. His own stem cells--his adult stem cells, not embryonic
stem cells--cured him. His heart function has improved by 70 percent.
David is alive and well, playing golf, and currently taking a cruise in
Belize. Without adult stem cell therapy, David would not be here.
Embryonic stem cell research, on the contrary, has not yielded this
kind of success that we have from adult stem cells. It makes sense to
direct public resources to what works. Prioritizing resources: It makes
sense for public resources to help those with heart disease, the No. 1
killer in the United States. It makes sense to encourage research that
will work for those with Parkinson's, diabetes, cancer, and autoimmune
diseases. Why would we want to desert patients in the United States by
spending dollars on research that has not been proven?
I will oppose H.R. 810 not only because of the ethical consequences
but because it doesn't prioritize our use of fiscal resources.
Let's be clear. There is no current policy in place that bans
embryonic stem cell research. Everybody knows that we are doing some
through the Federal Government because, being perfectly legal in the
United States, President Bush, in 2001, allowed taxpayer dollars to be
used for that research. This debate in the Senate today and tomorrow is
not whether we want to ban or allow research, it is whether we want to
spend our dollars on embryo creation and destruction.
Today, the Congress appropriates nearly $30 billion for medical
research through the National Institutes of Health. Every year,
hundreds of advocates come to my office to say that $30 billion is not
enough. They say these funds are important to continue research and
trials that are already started. So what would happen to those
arguments if there was a higher priority placed through passage of H.R.
810? Will we have to double the budget again for NIH like we did
between 1998 and 2003? I don't think that is possible given that was
already done starting in the year 1998. So it makes me wonder whether
we are prioritizing the use of Federal research dollars through the
National Institutes of Health the way we should.
We don't have an infinite amount of Federal funding. We cannot
pretend there is enough money to go around. We do have to prioritize.
So I urge my colleagues to realize that Congress can only disburse so
many funds. We can only fix so many problems. Therefore, we need to
think rationally. We need to make tough choices. One of those tough
choices might be to pursue what is proven to work, which is greater use
of adult stem cells. The right choice, then, is to invest in what
works. Let's keep the ball rolling with research that has been proven.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Texas is recognized.
Mrs. HUTCHISON. Mr. President, I ask unanimous consent to have 5
minutes to talk as in morning business regarding the resolution that
will be on the Senate floor later tonight or tomorrow regarding
condemning Hezbollah.
The PRESIDING OFFICER. Is there objection? Without objection, it is
so ordered. The Senator from Texas is recognized for 5 minutes.
(The remarks of Mrs. Hutchison are printed in today's Record under
``Morning Business.'')
Mrs. HUTCHISON. I yield the floor.
The PRESIDING OFFICER. The Senator from Ohio.
Mr. VOINOVICH. Mr. President, I rise today in support of legislation
to expand the Federal investment in adult and umbilical cord blood stem
cell research, as well as scientific ways to create embryonic stem cell
lines without destroying human embryos.
It is important to point out that there are two very important
categories of stem cells. I know that my colleagues are going to have a
little difficulty with this because I have had difficulty with this.
This is medical terminology.
The first, embryonic stem cells, as their name suggests, are derived
from human embryos developed from eggs that have been fertilized in an
in vitro fertilization clinic. Removing stem cells from these embryos
destroys their potential life, making their use very controversial and
something I cannot morally support.
On the other hand, adult stem cells are undifferentiated cells found
among
[[Page S7612]]
differentiated cells in tissues or organs. Adult stem cells can renew
themselves and will eventually differentiate into a special cell.
However, before this occurs, the undifferentiated stem cells can be
gathered by scientists without any harm to the individual.
Also included in this ethical category of stem cells are those from
umbilical cord blood derived from the placenta of a newborn baby. With
the birth of my seventh grandchild last summer, I learned a great deal
about the benefits of preserving cord blood stem cells. Once considered
medical waste and discarded after birth, science has determined that
cord blood has the potential to save thousands of lives.
And that is exactly why I came to the floor today, to explain these
differences and to highlight the unmatched value of adult and cord
blood stem cells.
By the way, when I found out about the umbilical cord blood coming
from the placenta, we are now freezing that umbilical cord, and each
year we will pay some money to maintain it. But that umbilical cord can
be used to help my seventh grandchild or, for that matter, the whole
family. It is something more people should find out about.
I am concerned that the vast majority of Americans are unaware that
some of the most promising advances in medical research and treatment
today are not attributed to embryonic stem cells; rather, they are the
result of noncontroversial, nonlife-ending use of adult and umbilical
blood cord cells.
Unfortunately, many of the individuals who support embryonic stem
cell research have been kept in the dark about the advances of
umbilical and adult stem cell treatments and have been oversold on
embryonic stem cell research, which is still in its infancy.
While embryonic cells have never been successfully used to treat even
one disease--not used to treat one disease to date--adult stem cells
have been used to treat 72 diseases, such as breast cancer, multiple
sclerosis, rheumatoid arthritis, sickle cell anemia, spinal cord
injuries, and many others. I have read reports that adult stem cells
from a young girl's own fat cells were used to repair or regenerate a
19-square-inch section of her skull. I have also learned of a
Parkinson's patient who has been without the vast majority of the
disease's symptoms for 6 years after being treated with his own adult
stem cells.
Even more encouraging, the potential use of adult and umbilical cord
therapies continues to expand. In fact, there is a real possibility
that these types of stem cells will be able to yield the same results
as embryonic, or what they call pluripotent stem cells, without the
need to destroy human life.
The American Journal of Pathology recently reported that a group of
scientists have isolated a novel population of multipotent adult stem
cells from human hair follicles--think of that, human hair follicles--
which, like embryonic stem cells, express neural crest and neuron stem
cell markers, as well as the embryonic stem cell transcription factors.
In other words, what we are saying is that they produce the same
thing we would get if we were using the embryos that so many are
anxious to use.
I was introduced to the promise of adult and umbilical stem cell
research by experts at the National Center of Regenerative Medicine in
my hometown of Cleveland, OH. The individual institutions involved in
this partnership--Case Western Reserve University, University Hospital,
and the Cleveland Clinic--each bring an expertise to the center that is
leading the Nation in the use of nonembryonic stem cells to regenerate
new tissue and diseased organs rather than using drugs or devices to
improve the function of the organ.
The National Center for Regenerative Medicine team has told me that
they are interested in the rapid translation of adult and umbilical
cord stem cell technology into patients that is not possible today with
embryonic stem cells.
Since 1976, investigators at the center have studied nonembryonic
stem cells and performed their first stem cell transplant as early as
1980. That is back in 1980. Investigators at the center are now able to
cure leukemias and lymphomas with nonembryonic stem cell
transplantation, as well as to fix unstable bone fractures and treat
genetic disorders.
In the next several years, investigators at the center believe they
will be able to address cancer, bone, heart, and neurological disorders
with nonembryonic stem cell treatments. They are hopeful that the new
advances will lead to treatment of degenerative arthritis, will
decrease the severity of graft versus host disease after stem cell
transplantation, and allow physicians to use a patient's own stem cells
to repair heart damage following congestive heart failure, as well as
use their own neural stem cells to improve function after spinal cord
damage. All of the things that folks are talking about because we have
to have these embryonic stem cells because this is what we have to do--
we are already on our way. We are making progress with adult and with
umbilical cord stem cells.
The center has 10 ongoing or planned clinical trials to further
explore the use of stem cell therapies to reduce the risks of
chemotherapy, treat certain heart conditions, and improve umbilical
stem cell treatment for leukemia. I recently had the privilege to
personally hear two young Ohioans discuss the successful adult stem
cell treatment received at the center for an aggressive form of
leukemia and a severely broken bone that would not heal with
traditional treatment.
I will never forget this young woman who was there. It was a meeting
at the regenerative center. She talked about the fact that she was in
this terrible motorcycle accident. She was a mountain climber, she was
a skier, she was a runner. She was told by all of her doctors that she
wouldn't be able to run again, that she would have to hobble around.
She went to the Cleveland Clinic, to the regenerative center, and as a
result of using her stem cells, they were able to repair the problem
that she had in her leg.
Today she is running. I am getting goosebumps right now. I will never
forget it. She started to cry. She hugged her doctor. We all started to
cry. It was a miraculous thing using adult stem cells.
As a result, I support the legislation introduced by my colleagues
from Pennsylvania, the Alternative Pluripotent Stem Cell Therapies
Enhancement Act. The bill would require the Secretary of Health and
Human Services to develop techniques for the isolation, derivation,
protection or testing of stem cells not derived from a human embryo.
The bill would also require the Secretary to prioritize stem cell
research that will reap near-term clinical benefits. 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.
I have the greatest sympathy for patients and their families who
continue to struggle with a wide range of painful, life-ending
diseases. Further, I understand what it is like to watch a loved one
suffer and the tragedy of losing a member of your family, even a young
child, to a life-ending disease. I personally lost my father to
diabetes and my nephew C.T. to bone cancer. I have been a witness to
the devastating effects of Alzheimer's, arthritis, and many other
diseases.
One can hardly take issue with these individual efforts to seek out a
potential cure, but too often, I fear, proponents of embryonic stem
cell research provide patients with false promises from unproven,
unexplored embryonic stem cells, while ignoring the real substantial
progress that has been made with adult and blood cord treatments.
I am gravely concerned about the possible implication of spending
taxpayers' dollars on an issue such as embryonic stem cell research
that divides Americans on moral and ethical grounds, and I believe it
is my moral responsibility to direct the Federal Government's dollars
toward the areas of research that have the greatest near-term potential
to help the largest number of Americans.
Since I have been a Member of the Senate, we have doubled the funding
for the National Institutes of Health, NIH, and greatly increased the
amount of medical research the Federal Government is able to fund,
including increasing the amount of money available for research on all
stem cells from $226 million in 1999 to $568 million this year.
[[Page S7613]]
However, as you know, Mr. President, in recent years with the cost of
the war, the need to protect our homeland, and natural disasters such
as Katrina, the amount the Federal budget has available for these
priorities is getting smaller and smaller. We are seeing that now with
the appropriations bills in the Senate.
I meet with groups all the time, and they ask me for increases in
funding for research for diseases that personally impact on their
families. I am sure they visit your office, Mr. President, every couple
of weeks: We want more money for NIH to take care of this, to take care
of that. Just within my own family, I met recently with my former
brother-in-law in support of childhood cancer, and through my son I
have heard a very emotional presentation by a group of my constituents
on behalf of juvenile diabetes research. Again, if everyone in the
Senate had been at that meeting, I think they would have said: Look, we
have to do more, spend more money on juvenile diabetes.
There is a tremendous need to pursue treatments for these and many
other diseases, but we face a reality of limited funding. That is the
real world.
We have to be smart about spending our money, and in the current
budget environment, I have concerns that increasing funding for
research on embryonic stem cell will take away opportunities for
research in areas such as adult and umbilical cord blood research, or
even research for treatment of specific diseases such as cancer,
juvenile diabetes, and others that have proven their usefulness.
Consequently, and in light of all the advances and results science
has provided with adult and umbilical blood cord stem cells, I urge my
colleagues to continue to direct Federal funding toward the
noncontroversial areas of adult and umbilical cord blood stem cell
research. I urge my colleagues to do that.
Mr. President, I yield the floor.
The PRESIDING OFFICER. The Senator from Kansas.
Mr. BROWNBACK. Mr. President, as we are waiting for my colleagues to
come to the floor, I want to address some issues that have been brought
forward and talked about previously.
Mr. President, I see my colleague from Iowa, and I am prepared to
answer--he had raised a question about whether we had 72 different
areas of treatment for adult stem cells, and so I wanted to respond.
The PRESIDING OFFICER. Unfortunately, the majority's time has
expired.
Mr. BROWNBACK. Mr. President, I yield the floor.
Mr. HARKIN. Mr. President, I see the distinguished Senator from
Washington is here to make her statement on this bill, and I would
yield the floor to Senator Murray for her comments.
The PRESIDING OFFICER. The Senator from Washington is recognized.
Mrs. MURRAY. Mr. President, I thank my colleague for yielding me time
tonight on this important legislation. I rise tonight to express my
support for expanding stem cell research. This innovative research
offers us a chance to save lives.
Families across this country are holding out hope that we will
finally allow science to move forward and deliver on the promise of
stem cell research. That is exactly what we should be doing. But,
unfortunately, today the hands of American scientists are tied by
political restrictions. I believe we can expand stem cell research
while still maintaining strict ethical safeguards. That is why I will
be supporting H.R. 810.
Back in 2001, President Bush imposed restrictions on promising stem
cell research. Since that time, we have learned that there aren't as
many useful stem cell lines as the President suggested. The Bush
administration promised us that 60 lines would be available for
research. To date, only 15 are available, and it appears that all of
those lines have contamination problems. The President's restrictions
have held back American science and stalled promising research. It is
time to correct that mistake and allow our country to make progress.
Stem cell research is about improving medicine, and it is about
saving lives. For patients with Parkinson's or Alzheimer's, diabetes or
multiple sclerosis, stem cell research holds promising potential to
provide the tools to understand, treat, and someday cure these
devastating diseases.
I understand the challenges and frustrations these diseases cause.
When I was just 15 years old, my dad was diagnosed with multiple
sclerosis. In a few short years, his illness became very bad, so bad
that he couldn't work anymore, and for most of my life my dad was in a
wheelchair. His illness had a profound impact on my entire family. My
mom, who stayed home to raise seven kids, had to work to care for him
and had to get a job so she could support our family. She got that job,
but it was never enough to support seven kids and a husband who was in
a wheelchair and with growing medical bills.
I can only imagine how different our lives would have been had there
been a cure for M.S. Back then, we didn't have the tools to find a
cure, but today we do, and these tools unfortunately are being blocked
by an ideological policy that puts politics over science. I think we
can do better than that.
My dad's challenges are similar to the struggles millions of
Americans and their families face every day. They deserve a chance, and
they deserve hope. That is why we can't let the current restrictions
stand.
A short time ago, I received a letter from a constituent of mine who
lives in Mercer Island, and he wrote:
My 17-year-old son was recently involved in an automobile
accident and is now paralyzed from the upper chest down. Stem
cell research looks to be our brightest hope by far. Please
help give him the chance to ride a bike, go for a hike, and
run with his friends again. Please, support stem cell
research.
As that father points out, this is about people. It is about keeping
our country on the cutting edge of science and research, and I am proud
to represent a State that has a strong reputation for scientific
research. But for our country to remain a leader in this promising
field, our scientists and our researchers need the support of our
Government. America should never take a back seat to other countries in
the search for promising new cures.
Unfortunately, the President's current stem cell research policy is
tying the hands of our scientists by limiting the number of lines
eligible for Federal funding. We can do better than that.
In fact, the majority of this Congress has been trying to correct the
President's mistake for over a year now. H.R. 810 passed the House of
Representatives 13 months ago. Since that date, my colleagues and I
have been fighting to bring this issue of stem cell research to the
Senate floor. We wrote letters, we pleaded on the floor, and we asked
Republican leaders numerous times for even a few hours to debate and
pass this bipartisan bill. Our efforts to promote research and offer
hope had been denied at every turn. But now, finally, our day has come,
and after more than a year of obstruction, we finally have a chance to
offer hope to millions of patients and their families. On a bipartisan
basis, I believe this bill will pass.
But, of course, we know that is not the whole story. Shortly after we
got word that this bill would finally come to the floor, I was dismayed
to see headlines announcing that Karl Rove, President Bush's chief
political officer and adviser, guaranteed a veto of this important
bill. In nearly 6 years in office, President Bush has never once vetoed
a bill. It is pretty amazing to me that he would choose this bill--this
bill which offers basic hope and opportunity to so many Americans--for
his first veto. I believe the President is wrong on this issue, and I
think threatening a veto is wrong.
I am here this evening to pledge my support for this bill and to call
on my colleagues to support it. But next, I call on them to ask the
President in no uncertain terms to stand with us in support of open
opportunity, stand with us in support of medical research, stand with
us and, more importantly, with millions of Americans who are waiting on
a cure, in support of stem cell research.
For far too long, this administration's ideology has trumped
research. Politics has been more important than science. With this
bill, President Bush has a chance to change course and put people ahead
of personal political ideology. I urge him to do the right thing.
For our patients, for their families, and for the future of our
Nation's research leadership, it is time for the Senate to pass H.R.
810, and it is time for the President to sign it. Let's take the
handcuffs off of our scientists and
[[Page S7614]]
let them find the cures that will save lives.
Mr. President, I yield the floor.
Mr. HARKIN. Mr. President, I thank the Senator from Washington for
her very eloquent statement, and I thank all of the Senators who have
come over here today to speak on this important issue.
We have about 20 minutes left in this half hour. I don't have any
other Senators right now, but if there are other Senators on our side
who wish to take a few minutes to speak on this bill, I would be glad
to yield to them.
However, I would like to take this time to sum up, if I can, what we
have heard today. We have come to the end of our first day of debate on
stem cell research, and I think it has been a very enlightening debate
and a very good exposition of the different sides of this issue. I hope
the American people who have tuned in to watch this have learned a
great deal about why we need to pass H.R. 810, the Stem Cell Research
Enhancement Act. As we know, that bill passed the House by a bipartisan
majority over a year ago, and I think it has a strong bipartisan
majority here in the Senate. Certainly the bill itself is sponsored
bipartisanly. If we can pass it tomorrow--and I am confident we can and
we will--H.R. 810 can go straight to the President's desk.
I would like to reiterate a few things we have heard today.
First, H.R. 810 has enormous popular support. I have here a letter
that was just transmitted to me, and it is a list of different advocacy
groups, health organizations, research universities, scientific
societies, religious groups, and other interested institutions and
associations representing millions of patients, scientists, health care
providers, and advocates, writing in strong support for H.R. 810. They
point out in this letter that this is the bill which holds promise for
expanding medical breakthroughs. The other two bills, the Alternative
Pluripotent Stem Cell Therapies Enhancement Act, S. 2754, and the Fetus
Farming Prohibition Act, S. 3504, are not substitutes for a ``yes''
vote on H.R. 810.
This letter is signed by 590 advocacy groups. I have been on this
Senate floor now 21 years. We all get letters and things that come in
expressing support, but I daresay I have never seen anything as
overwhelming as this: 590 different groups. Earlier this year, I
submitted a list of 205 different groups.
Mr. President, I ask unanimous consent that at the conclusion of my
comments on this portion, this list of 590 groups be printed in the
Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Mr. HARKIN. I thank the Presiding Officer.
Again, those are advocacy groups and scientific associations--590.
How about the American people? Three out of four Americans agree:
support stem cell research. The question asked in a national poll: Do
you support embryonic stem cell research? Seventy-two percent of
Americans said yes. Seventy-two percent. That is pretty overwhelming.
I heard the distinguished Senator from Ohio here just a few moments
ago say that one of the reasons he was opposed to the bill was because
we wanted to do things that would not divide Americans. He thought this
would divide Americans. Divide Americans? Seventy-two percent are in
favor of it. Over 590 different advocacy groups expressing support, and
205 other disease-related groups all in support. This doesn't divide
America at all. Of course, there is always going to be somebody opposed
to something around here. But I haven't seen anything that received
this much overwhelming support in a long time. As a matter of fact,
passing embryonic stem cell research, H.R. 810, will pull Americans
together in the fight against disease. And it is bipartisan. As I said,
the bill passed the House bipartisanly. The sponsors of the bill itself
were three Republicans and three Democrats.
It was stated earlier today a couple of times about a letter that
former First Lady Nancy Reagan had written. I thought I would have it
blown up and put on a chart for people around the country to take a
look at, just to show you how this has nothing to do with partisanship.
It shows it is from the office of Nancy Reagan dated May 1, 2006, a
letter to Orrin Hatch, Senator Orrin Hatch of Utah, who was one of the
cosponsors of this bill. It says:
Dear Orrin:
Thank you for your continued commitment to helping the
millions of Americans who suffer from devastating and
disabling diseases. Your support has given so much hope to so
many.
It has been nearly a year since the United States House of
Representatives first approved the stem cell legislation that
would open the research so we could fully unleash its
promise. For those who are waiting every day for scientific
progress to help their loved ones, the wait for U.S. Senate
action has been very difficult and hard to comprehend.
I understand that the U.S. Senate is now considering voting
on H.R. 810, the Stem Cell Research Enhancement Act, sometime
this month. Orrin, I know I can count on friends like you to
help make sure this happens. There is just no more time to
wait.
Sincerely, Nancy.
When you have seen a loved one suffer from Alzheimer's--I am sure as
Mrs. Reagan watched the former President suffer from Alzheimer's--it
motivates you to say: Whatever we can do to advance the research, to
hopefully get a cure someday, that is what we should do.
For those of us who have friends who have Parkinson's disease, those
of us who have seen friends and loved ones die of Lou Gehrig's disease,
for those of us who have members of our family or close friends who
have had spinal cord injuries, this motivates us to do everything
humanly possible to expand this field of research.
My friend Christopher Reeve said, one time when we had watched a film
of a rat, a white mouse or white rat, that had its spinal cord damaged
so it couldn't walk and then it received embryonic stem cells and then
it walked again, Christopher Reeve, former Superman said, ``Oh, to be a
rat.''
It holds so much promise, embryonic stem cell research, to ease the
suffering and the pain of so many people.
I hear today talk about we have to do adult stem cells; maybe there
is not enough money.
Again, I refer to my friend from Ohio, who was here earlier who said
funding for medical research is probably going down because of the war
and because of Katrina and because of homeland security.
I said: Wait a minute, earlier this year this Senate voted 73 to 27,
to put $7 billion back in the budget so we wouldn't cut medical
research--73 votes in the Senate. I don't know, 73 votes is pretty
overwhelming. It was $7 billion we were supposed to put back in to help
medical research. I don't know to what the Senator was referring.
I have heard talk today about adult stem cells and all these other
things and how we had adult stem cells do this and adult stem cells do
that. Why haven't embryonic stem cells led to treatment as much as
adult stem cells have? Scientists have been doing research on adult
stem cells for over 30 years, and we still, after 30 years, have not
extracted one stem cell line from adult cells--not one.
Now embryonic stem cells were only derived in 1998, 8 years ago, and
they have only been getting Federal funding in a limited manner since
2002, under the guidelines the President set down in 2001, which
limited the number of stem cell lines to then 78, which we found out
later was only 21 stem cell lines.
Again, there are no arbitrary restrictions on research on adult stem
cells. Scientists and private companies don't have to be skittish about
doing the research. They don't have to worry that all of a sudden the
Federal Government is going to ban it or limit it, so they can plan
ahead and do long-term research.
Let's compare that situation with human embryonic stem cells. As I
said, we didn't derive them until 1998 and the first Federal grant
wasn't awarded until 2002. Even now, only a tiny fraction of the total
Federal budget for human stem cell research is used for human embryonic
stem cells. The vast majority still goes for adult stem cells.
Here it is. I pointed this out earlier today. Human embryonic stem
cells in fiscal 2006 from NIH, $38.3 million. Adult stem cells, $200
million. Again, only a tiny fraction going for human embryonic stem
cells. Five times as much is going for adult stem cell research. So it
is no wonder, after 30 years and all this research and all this money,
that more diseases are being treated today with adult stem cells.
Scientists have only been studying embryonic stem cells for 5 years,
with
[[Page S7615]]
one arm tied behind their back. That one arm being tied their back by
the President's proclamation of August 9, 2001, that only stem cell
lines derived before 9 p.m. that evening could receive Federal funding.
Anything derived after 9 p.m. could not receive Federal funding.
I have wondered ever since, why was it morally acceptable to use stem
cell lines derived prior to 9 p.m. on August 9 of 2001 but morally
unacceptable for funding of stem cell lines derived after 9 p.m. Can
someone please tell me the ethics of that. Can someone please tell me
why 9 p.m. on August 9 of 2001 is some kind of a moral dividing line?
It is totally arbitrary. The President could have said stem cell lines
derived at 10 p.m. or he could have said stem cell lines derived before
Christmas of this year. It is the same thing. No one has taken this
floor to define why August 9, at 9 p.m, is some kind of a moral
dividing line.
The fact is, it doesn't really matter what I think about the
potential of embryonic stem cell research. It doesn't matter a heck of
a lot what other Senators may think about the potential of embryonic
stem cell research. What matters is what does the great body of
scientists think about the potential.
The overwhelming majority of reputable biomedical scientists also
believes we should pursue embryonic stem cell research; not to the
exclusion of others but that we should pursue it.
I have a letter from Dr. J. Michael Bishop who won the Nobel Prize in
medicine in 1989. Here is what he says:
The vast majority of the biomedical community believes that
human embryonic stem cells are likely to be the source of key
discoveries relating to many debilitating diseases. In fact,
some of the strongest advocates for human embryonic stem cell
research are those scientists that have devoted their careers
to the study of adult stem cells.
I have a letter from Dr. Alfred G. Gilman, who won the Nobel Prize in
medicine in 1994.
It has become obvious, however, that the number of stem
cell lines actually available under current policy is too
small and is controlled by a limited monopoly, which has made
it significantly more difficult and expensive for research to
be conducted. These limits have hindered the important search
for new understanding and treatment of devastating diseases.
I have a letter from the Director of the NIH, Dr. Elias Zerhouni.
Embryonic stem cell research holds great promise for
treating, curing, and improving our understanding of disease.
The breakthroughs are coming. But they take time. They take a lot of
scientists researching. This is not something you can put two people
on. They need a lot of different lines. Embryonic stem cell research
should be ongoing at universities all across America, at our great
research institutions, and it ought to be done under the guidance and
direction and ethical guidelines of NIH and the ethical guidelines that
we have in this bill.
The clampdown on embryonic stem cell research before it even has a
chance to start shows a total lack of understanding about how science
works, how research works. I have often said that basic research is
similar to having 10 doors and they are closed. There is a high
probability that behind one of the doors is the answer to your
question. If you open one door, you know what the odds are of finding
the right answer. If you open two doors, the odds are a little bit
better. If you open five doors, the odds are 50-50.
That is what basic research is about. It has been said here a lot of
the earlier research on fetal tissue came to nothing. A lot of basic
research comes to nothing--in terms of an actual application. But
almost all basic research adds to our body of knowledge. Maybe, from
one of those basic research grants that was put on the shelf, some
other scientist coming along later on might pick something from that,
put two or three together and find something.
I am reminded of John Embers, a scientist--I believe he was at
Harvard. I will check my facts on that, but I believe he was a doctor
at Harvard many years ago. I am talking about a long time ago. I am
talking about in the 1940s. He had done some interesting research,
basic research on kidney cells of monkeys because they had unique
properties. It was a funny research. It was on certain Rhesus monkeys
and the oddity of certain kidney cells.
Dr. John Enders didn't get anything for it. He did the research, put
it on the shelf, and nothing ever came of it, until a few years later
another scientist, examining in another area, remembered Dr. Enders'
work, went back and got it, coupled it with his, and came up with
something called the Salk polio vaccine. It wasn't until over 25 years
later that Dr. John Enders finally received the Nobel Prize for his
research.
But I suppose someone 5 years after Dr. Enders had done his research
would have said: Why did we spend money on that foolish kind of
research? It didn't lead to anything. It kept some scientists employed,
but it didn't lead to anything. But Dr. Salk came along, coupled that
research with what he was doing and came up with the Salk polio
vaccine.
That is a true story.
Again, we have to understand a lot of this is basic research. A lot
of it will lead to nothing. But as more and more scientists get
involved in examining embryonic stem cells and how they grow, how they
multiply, how they differentiate, how they become nerve tissue, how
they become brain tissue, how they become skin tissue, how they become
blood tissues--as they begin to investigate that, I am sure there will
be a lot of blind alleys. But I submit that everything that is done
builds the body of scientific evidence that we need, the science that
will eventually lead to a cure of a disease. That is the promise of
embryonic stem cell research. To stop it now or to limit it doesn't
make sense.
People talk about the ethics and morality. I have heard talk about we
have to protect innocent life. This is an embryo; an embryo with 100
cells, 200 cells. You can take whatever view you want of that embryo.
The point is that the bill we are talking about does not destroy one
embryo. It only says that we can get funding for the research on those.
These are embryos that are going to be discarded anyway, in in vitro
fertilization clinics. They are being discarded every day.
Why don't people come out and say: Stop in vitro fertilization. Make
it a crime. You don't hear anybody saying that because 50,000 babies
were born last year to people who wanted to have a baby and couldn't
have one and used in vitro fertilization. Once they have their
children, they call up the in vitro clinic and say: I don't want the
remaining embryos, just discard them. I ask you, what is the moral
thing to do, just discard them or, with the written consent of the
donors, use those embryonic stem cells to save lives and ease suffering
and cure disease? That, to me, is the moral and the ethical choice.
I see my time is up and I yield the floor.
Exhibit 1
U.S. Senate,
Washington, DC, July 14, 2006.
Dear Senator: We, the undersigned patient advocacy groups,
health organizations, research universities, scientific
societies, religious groups and other interested institutions
and associations, representing millions of patients,
scientists, health care providers and advocates, write you
with our strong and unified support for H.R. 810, the Stem
Cell Research Enhancement Act. We urge your vote in favor of
H.R. 810 when the Senate considers the measure next week.
Of the bills being considered simultaneously, only H.R. 810
will move stem cell research forward in our country. This is
the bill which holds promise for expanding medical
breakthroughs. The other two bills--the Alternative
Pluripotent Stem Cell Therapies Enhancement Act (S. 2754) and
the Fetus Farming Prohibition Act (S. 3504)--are NOT
substitutes for a YES vote on H.R. 810.
H.R. 810 is the pro-patient and pro-research bill. A vote
in support of H.R. 810 will be considered a vote in support
of more than 100 million patients in the U.S. and substantial
progress for research. Please work to pass H.R. 810
immediately.
Sincerely,
A O North America; AAALAC International; AARP; Abbott
Laboratories; Acadia Pharmaceuticals; Accelerated Cure
Project for Multiple Sclerosis; Adams County Economic
Development, Inc.; AdvaMed (Advanced Medical Technology
Association); Affymetrix, Inc.; Albert Einstein College
of Medicine of Yeshiva University; Alliance for Aging
Research; Alliance for Lupus Research; Alliance for
Stem Cell Research; Alnylam US, Inc.; Alpha-1
Foundation; ALS Association; Ambulatory Pediatric
Association; AMDeC-Academic Medicine Development Co.;
America on the Move Foundation; American Academy of
Neurology.
American Academy of Nursing; American Academy of
Pediatric Dentistry; American Academy of Pediatrics;
American Association for Cancer Research;
[[Page S7616]]
American Association for Dental Research; American
Association for Geriatric Psychiatry; American
Association for the Advancement of Science; American
Association of Anatomists; American Association of
Colleges of Nursing; American Association of Colleges
of Osteopathic Medicine; American Association of
Colleges of Pharmacy; American Association of
Neurological Surgeons/Congress of Neurological
Surgeons; American Association of Public Health
Dentistry; American Autoimmune Related Diseases
Association; American Brain Coalition; American Chronic
Pain Association; American College of Cardiology;
American College of Medical Genetics; American College
of Neuropsychopharmacology; American College of
Obstetricians and Gynecologists.
American College of Surgeons; American Council on
Education; American Council on Science and Health;
American Dental Association; American Dental Education
Association; American Diabetes Association; American
Federation for Aging Research; American
Gastroenterological Association; American Geriatrics
Society; American Institute for Medical and Biological
Engineering; American Lung Association; American
Medical Association; American Medical Informatics
Association; American Medical Women's Association;
American Pain Foundation; American Parkinson's Disease
Association; American Parkinson's Disease Association
(Arizona Chapter); American Pediatric Society; American
Physiological Society; American Psychiatric
Association.
American Psychological Association; American Public
Health Association; American Society for Biochemistry
and Molecular Biology; American Society for Bone and
Mineral Research; American Society for Cell Biology;
American Society for Clinical Pharmacology and
Therapeutics; American Society for Microbiology; American
Society for Neural Transplantation and Repair; American
Society for Nutrition; American Society for Pharmacology
and Experimental Therapeutics; American Society for
Reproductive Medicine; American Society for Virology;
American Society of Clinical Oncology; American Society of
Critical Care Anesthesiologists; American Society of
Hematology; American Society of Human Genetics; American
Society of Nephrology; American Society of Tropical
Medicine and Hygiene; American Surgical Association;
American Surgical Association Foundation.
American Thoracic Society; American Thyroid Association;
American Transplant Foundation; Americans for Medical
Progress; amFAR, The Foundation for AIDS Research;
Arizona State University College of Nursing; Arthritis
Foundation; Arthritis Foundation, Rocky Mountain
Chapter; Association for Clinical Research Training;
Association for Medical School Pharmacology Chairs;
Association for Prevention Teaching and Research;
Association for the Accreditation of Human Research
Protection Programs, Inc.; Association of Academic
Chairs of Emergency Medicine; Association of Academic
Departments of Otolaryngology; Association of Academic
Health Centers; Association of Academic Physiatrists;
Association of American Medical Colleges; Association
of American Physicians; Association of American
Universities; Association of American Veterinary
Medical Colleges.
Association of Anatomy, Cell Biology and Neurobiology
Chairs; Association of Anesthesiology Program
Directors; Association of Black Cardiologists;
Association of Chairs of Departments of Physiology;
Association of Independent Research Institutes;
Association of Medical School Microbiology and
Immunology Chairs; Association of Medical School
Pediatric Department Chairs; Association of Medical
School Pharmacology Chairs; Association of Professors
of Dermatology; Association of Professors of Human and
Medical Genetics; Association of Professors of
Medicine; Association of Public Health Laboratories;
Association of Reproductive Health Professionals;
Association of Schools and Colleges of Optometry;
Association of Specialty Professors; Association of
University Anesthesiologists; Assurant Health; Asthma
and Allergy Foundation of America; Athena Diagnostics;
Aurora Economic Development Council.
Axion Research Foundation; B'nai B'rith International;
Baylor College of Medicine; Baylor College of Medicine
Graduate School of Biomedical Sciences; Biotechnology
Industry Organization; BloodCenter of Wisconsin, Inc.;
Blue Cross and Blue Shield Foundation on Health Care;
Boston Biomedical Research Institute; Boston University
School of Dental Medicine; Boston University School of
Public Health; Brigham and Women's Hospital; Bristol-
Myers Squibb Company; Broadened Horizons, LLC; Brown
Medical School; Buck Institute for Age Research; Bums &
Allen Research Institute; Burrill & Company; Burroughs
Wellcome Fund; C3: Colorectal Cancer Coalition;
California Biomedical Research Association.
California Institute of Technology; California Institute
for Regenerative Medicine; California Wellness
Foundation; Californians for Cures; Campaign for
Medical Research; Cancer Research and Prevention
Foundation; Canon U.S. Life Sciences, Inc.; Case
Western Reserve University School of Dentistry; Case
Western Reserve University School of Medicine; Cedars-
Sinai Health System; Center for the Advancement of
Health; Central Conference of American Rabbis; CFIDS
Association of America; Charles R. Drew University of
Medicine and Science; Charles River Laboratories; Child
& Adolescent Bipolar Foundation; Children's Memorial
Research Center; Children's Neurobiological Solutions
Foundation; Children's Research Institute (Columbus);
Children's Research Institute (Washington).
Children's Tumor Foundation; Childrens Hospital Boston;
Christopher Reeve Foundation; City and County of
Denver; City of Hope National Medical Center; Cold
Spring Harbor Laboratory; Coleman Institute for
Cognitive Disabilities, University of Colorado System;
Colfax Marathon Partnership, Inc.; Colorado Bioscience
Association; Colorado Office of Economic Development
and International Trade; Colorado State University;
Columbia University; Columbia University College of
Dental Medicine; Columbia University Medical Center;
Community Health Partnership; Conference of Boston
Teaching Hospitals; Connecticut United for Research
Excellence, Inc.; Conquer Fragile X Foundation; Cornell
University; Council for the Advancement of Nursing
Science (CANS).
Creighton University School of Medicine; CURE (Citizens
United for Research in Epilepsy); Cure Alzheimer's
Fund; Cure Paralysis Now; CuresNow; Damon Runyon Cancer
Research Foundation; Dana-Farber Cancer Institute;
Dartmouth Medical School; David Geffen School of
Medicine at UCLA; DENTSPLY International; Digene
Corporation; Discovery Partners International; Doheny
Eye Institute; Drexel University College of Medicine;
Drexel University School of Public Health; Duke
University Medical Center; Dystonia Medical Research
Foundation; East Tennessee State University James H.
Quillen College of Medicine; Eli Lilly and Company;
Elizabeth Glaser Pediatric AIDS Foundation.
Emory University; Emory University Nell Hodgson Woodruff
School of Nursing; Emory University Rollins School of
Public Health; Emory University School of Medicine;
FasterCures; FD Hope Foundation; Federation of American
Scientists; Federation of American Societies for
Experimental Biology (FASEB); Federation of State
Medical Boards of the United States, Inc.; Fertile
Hope; Fitzsimons Redevelopment Authority; Florida
Atlantic University Division of Research; Ford Finance,
Inc.; Fox Chase Cancer Center; Fred Hutchinson Cancer
Research Center; Friends of Cancer Research, Friends of
the National Institute for Dental and Craniofacial
Research, Friends of the National Institute of Nursing
Research; Friends of the National Library of Medicine;
Genetic Alliance.
Genetics Policy Institute; George Mason University;
Georgetown University Medical Center; Guillain Barre
Syndrome Foundation International; Gynecologic Cancer
Foundation; Hadassah; Harvard University; Harvard
University School of Dental Medicine; Harvard
University School of Public Health; Hauptman-Woodward
Medical Research Institute, Inc.; Hereditary Disease
Foundation, HHT Foundation International, Inc.; Home
Safety Council; Howard University College of Dentistry;
Howard University College of Medicine; Huntington's
Disease Society of America; IBM Life Sciences Division;
Illinois State University Mennonite College of Nursing;
ImmunoGen, Inc.; Indiana University School of
Dentistry.
Indiana University School of Medicine; Indiana University
School of Nursing; Infectious Diseases Society of
America; Institute for African American Health, Inc.;
Intercultural Cancer Council Caucus; International
Foundation for Anticancer Drug Discovery (IFADD);
International Longevity Center--USA; International
Society for Stem Cell Research; Invitrogen Corporation;
Iraq Veterans for Cures; Iris Alliance Fund; Iron
Disorders Institute; Jacobs Institute of Women's
Health; Jeffrey Modell Foundation; Johns Hopkins; Johnson
& Johnson; Joint Commission on Accreditation of Healthcare
Organizations (JCAHO); Joint Steering Committee for Public
Policy; Juvenile Diabetes Research Foundation; Keck School
of Medicine of the University of Southern California.
Kennedy Krieger Institute; Keystone Symposia on Molecular
and Cellular
[[Page S7617]]
Biology; KID Foundation; Kidney Cancer Association; La
Jolla Institute for Allergy and Immunology; Lance
Armstrong Foundation; Lawson Wilkins Pediatric
Endocrine Society; Leukemia and Lymphoma Society;
Lombardi Comprehensive Cancer Center, Georgetown
University; Los Angeles Biomedical Research Institute
at Harbor-UCLA Medical Center; Louisiana State
University Health Sciences Center; Louisiana State
University Health Sciences Center School of Dentistry;
Lovelace Respiratory Research Institute; Loyola
University of Chicago Stritch School of Medicine; Lung
Cancer Alliance; Lupus Foundation of America, Inc.;
Lupus Foundation of Colorado, Inc.; Lupus Research
Institute; Lymphatic Research Foundation; Mailman
School of Public Health of Columbia University.
Malecare Prostate Cancer Support; March of Dimes Birth
Defects Foundation; Marine Biological Laboratory;
Marshalltown [IA] Cancer Resource Center; Masonic
Medical Research Laboratory; Massachusetts
Biotechnology Council; Massachusetts General Hospital;
Massachusetts Institute of Technology; MaxCyte, Inc.;
McLaughlin Research Institute; Medical College of
Georgia; Medical University of South Carolina; Medical
University of South Carolina College of Nursing;
MedStar Research Institute (MRI); Meharry Medical
College School of Dentistry; Memorial Sloan-Kettering
Cancer Center; Memory Pharmaceuticals; Mercer
University; Metro Denver Economic Development
Corporation; Miami Children's Hospital.
Midwest Nursing Research Society; Morehouse School of
Medicine; Mount Sinai Medical Center; Mount Sinai
School of Medicine; National Alliance for Eye and
Vision Research; National Alliance for Hispanic Health;
National Alliance for Research on Schizophrenia and
Depression; National Alliance on Mental Illness;
National Alopecia Areata Foundation; National Asian
Women's Health Organization; National Association for
Biomedical Research; National Association of Hepatitis
Task Forces; National Caucus of Basic Biomedical
Science Chairs; National Coalition for Cancer Research;
National Coalition for Cancer Survivorship; National
Coalition for Women with Heart Disease; National
Committee for Quality Health Care; National Council of
Jewish Women; National Council on Spinal Cord Injury;
National Down Syndrome Society.
National Electrical Manufacturers Association; National
Foundation for Ectodermal Dysplasias; National Health
Council; National Hemophilia Foundation; National
Hispanic Health Foundation; National Jewish Medical and
Research Center; National Marfan Foundation; National
Medical Association; National Multiple Sclerosis
Society; National Osteoporosis Foundation; National
Partnership for Women and Families; National
Pharmaceutical Council; National Prostate Cancer
Coalition; National Quality Forum; National Spinal Cord
Injury Association; National Venture Capital
Association; Nebraskans for Research; Nemours; New
Jersey Association for Biomedical Research; New Jersey
Dental School.
New York Blood Center; New York College of Osteopathic
Medicine; New York State Association of County Health
Officials; New York Stem Cell Foundation; New York
University College of Dentistry; New York University
School of Medicine; New York-Presbyterian Hospital;
North American Brain Tumor Coalition; North Carolina
Association for Biomedical Research; Northwest Association
for Biomedical Research; Northwestern University;
Northwestern University, The Feinberg School of Medicine;
Nova Southeastern University College of Dental Medicine;
Novartis Pharmaceuticals; Oklahoma Medical Research
Foundation; Oral Health America; Oregon Health & Science
University; Oregon Health & Science University School of
Nursing; Oregon Research Institute; Oxford Bioscience
Partners.
Pacific Health Research Institute; Paralyzed Veterans of
America; Parent Project Muscular Dystrophy; Parkinson's
Action Network; Parkinson's Disease Foundation;
Partnership for Prevention; Pennsylvania Society for
Biomedical Research; Pharmaceutical Research and
Manufacturers of America; Pittsburgh Development
Center; Princeton University; Project A.L.S.; Prostate
Cancer Foundation; Pseudoxanthoma Elasticum
International; Quest for the Cure; RAND Health;
Research! America; Resolve: The National Infertility
Association; RetireSafe; Rett Syndrome Research
Foundation; Rice University.
Robert Packard Center for ALS Research at Johns Hopkins;
Rosalind Franklin University of Medicine and Science;
Rush University Medical Center; Rutgers University;
Salk Institute for Biological Studies; sanofi-aventis;
Scleroderma Research Foundation; Secular Coalition for
America; Sjogren's Syndrome Foundation, Inc.; Society
for Advancement of Violence and Injury Research
(SAVIR); Society for Assisted Reproductive Technology;
Society for Education in Anesthesia; Society for Male
Reproduction and Urology; Society for Neuroscience;
Society for Pediatric Research; Society for
Reproductive Endocrinology and Infertility; Society for
Women's Health Research; Society of Academic
Anesthesiology Chairs; Society of General Internal
Medicine; Society of Gynecologic Oncologists.
Society of Reproductive Surgeons; Society of University
Otolaryngologists; South Alabama Medical Science
Foundation; South Dakota State University; Southern
Illinois University School of Medicine; Spina Bifida
Association of America; Stanford University; State
University of New York at Buffalo School of Dental
Medicine; State University of New York Downstate
Medical Center College of Medicine at Brooklyn; State
University of New York Upstate Medical University; Stem
Cell Action Network; Stem Cell Research Foundation;
Steven and Michele Kirsch Foundation; Stony Brook
University, State University of New York; Strategic
Health Policy International, Inc.; Student Society for
Stem Cell Research; Suicide Prevention Action Network-
USA (SPAN); Take Charge! Cure Parkinson's, Inc.;
Targacept, Inc.;
Temple University School of Dentistry; Texans for
Advancement of Medical Research; Texas A&M University
Health Science Center; Texas Medical Center; Texas Tech
University Health Sciences Center; The Arc of the
United States; The Association for Research in Vision
and Ophthalmology; The Biophysical Society; The Brody
School of Medicine at East Carolina University; The
Burnham Institute; The CJD Foundation; The Critical
Path Institute (C-Path); The Endocrine Society; The
FAIR Foundation; The Food Allergy and Anaphylaxis
Network; The Food Allergy Project, Inc.; The Forsyth
Institute; The Foundation Fighting Blindness; The
George Washington University Medical Center. The
Georgetown University Center for the Study of Sex
Difference in Health, Aging and Disease.
The Gerontological Society of America; The J. David
Gladstone Institutes; The Jackson Laboratory; The Johns
Hopkins University Bloomberg School of Public Health;
The Johns Hopkins University School of Nursing; The
Medical College of Wisconsin; The Medical Foundation,
Inc., The Michael J. Fox Foundation for Parkinson's
Research; The Ohio State University College of
Dentistry; The Ohio State University College of
Medicine and Public Health; The Ohio State University
School of Public Health; The Parkinson Alliance and
Unity Walk; The Research Foundation for Mental Hygiene,
Inc.; The Rockefeller University; The Schepens Eye
Research Institute; The Scientist; The Scripps Research
Institute; The Smith-Kettlewell Eye Research Institute;
The Society for Investigative Dermatology; The Spiral
Foundation.
The University of Chicago Pritzker School of Medicine;
The University of Iowa Carver College of Medicine; The
University of Iowa College of Dentistry; The University
of Iowa College of Public Health; The University of
Mississippi Medical Center; The University of
Mississippi Medical Center School of Dentistry; The
University of Oklahoma College of Dentistry; The
University of Oklahoma Health Sciences Center; The
University of Tennessee Health Science Center; The
University of Tennessee HSC College of Nursing; The
University of Texas Health Science Center at Houston;
The University of Texas Health Science Center at San
Antonio; The University of Texas M.D. Anderson Cancer
Center; The University of Texas Medical Branch at
Galveston School of Medicine; The University of Texas
Southwestern Medical Center; The University of Toledo
Academic Health Science Center; Tourette Syndrome
Association; Travis Roy Foundation; Tufts University
School of Dental Medicine; Tulane University.
Tulane University Health Sciences Center; Union for
Reformed Judaism; Union of Concerned Scientists;
Unitarian Universalist Association of Congregations;
United Spinal Association; University of Alabama at
Birmingham School of Medicine; University of Alabama at
Birmingham School of Nursing; University of Alabama at
Birmingham School of Public Health; University of
Arizona College of Medicine; University of Arkansas for
Medical Sciences; University of Buffalo; University of
California System; University of California, Berkeley;
University of California, Berkeley School of Public
Health; University of California, Davis; University of
California, Irvine; University of California, Los
Angeles; University of California, Los Angeles School
of Dentistry; University of California, Los Angeles
School of Medicine; University of California, San
Diego.
[[Page S7618]]
University of California, San Francisco; University of
California, San Francisco School of Dentistry;
University of California, San Francisco School of
Nursing; University of California, Santa Cruz;
University of Chicago; University of Cincinnati Medical
Center; University of Colorado at Denver and Health
Sciences Center; University of Colorado at Denver and
HSC School of Dentistry; University of Colorado at
Denver and HSC School of Nursing; University of
Connecticut School of Medicine; University of Florida;
University of Florida College of Dentistry; University
of Georgia; University of Illinois; University of
Illinois at Chicago; University of Illinois at Chicago
College of Dentistry; University of Illinois at Chicago
College of Nursing; University of Iowa; University of
Kansas; University of Kansas Medical Center.
University of Kansas Medical Center School of Nursing;
University of Kentucky; University of Kentucky College
of Dentistry; University of Louisville; University of
Louisville School of Dentistry; University of Maryland
at Baltimore; University of Maryland at Baltimore
College of Dental Surgery; University of Maryland at
Baltimore School of Nursing; University of Miami;
University of Michigan; University of Michigan College
of Pharmacy; University of Michigan Medical
School; University of Michigan School of Dentistry;
University of Michigan School of Nursing; University of
Michigan School of Public Health; University of Minnesota;
University of Minnesota School of Public Health;
University of Missouri at Kansas City School of Dentistry;
University of Montana School of Pharmacy and Allied Health
Sciences; University of Nebraska Medical Center.
University of Nebraska Medical Center College of
Dentistry; University of Nevada, Las Vegas School of
Dental Medicine; University of Nevada, Reno School of
Medicine; University of North Carolina at Chapel Hill;
University of North Carolina at Chapel Hill School of
Dentistry; University of North Carolina at Chapel Hill
School of Public Health; University of North Dakota;
University of North Texas Health Science Center;
University of Oregon; University of Pennsylvania School
of Dental Medicine; University of Pennsylvania School
of Medicine; University of Pennsylvania School of
Nursing; University of Pittsburgh Graduate School of
Public Health; University of Pittsburgh School of
Dental Medicine; University of Pittsburgh School of
Medicine; University of Rochester Medical Center;
University of Rochester School of Medicine and
Dentistry; University of Rochester School of Nursing;
University of South Carolina Office of Research and
Health Sciences; University of South Dakota School of
Medicine and Health Sciences.
University of South Florida; University of South Florida
College of Nursing; University of Southern California;
University of Southern California School of Dentistry;
University of Utah HSC School of Medicine; University
of Vermont College of Medicine; University of
Washington; University of Washington School of
Dentistry; University of Washington School of Nursing;
University of Washington School of Public Health and
Community Medicine; University of Wisconsin-Madison;
Van Andel Research Institute; Vanderbilt University and
Medical Center; Vanderbilt University School of
Nursing; Virginia Commonwealth University School of
Dentistry; Virginia Commonwealth University School of
Medicine; Wake Forest University School of Medicine;
Washington University in St. Louis; Washington
University in St. Louis Center for Health Policy;
Washington University in St. Louis School of Medicine.
WE MOVE; Weill Medical College of Cornell University;
Whitehead Institute for Biomedical Research; WiCell
Research Institution; Wisconsin Alumni Research
Foundation; Wisconsin Association for Biomedical
Research and Education; Woodruff Health Sciences Center
at Emory University; Wright State University; School of
Medicine; Yale University; Yale University School of
Medicine; Yale University School of Nursing.
The PRESIDING OFFICER. The Senator from Georgia.
Mr. CHAMBLISS. Mr. President, I rise today to speak about stem cell
research. This is a very delicate and very tough issue and these are
difficult decisions that we will all have to make this week.
Some scientists believe that advancement in research requires the
creation and development of new embryonic stem cell lines. The truth of
the matter is that there are very promising alternatives to embryonic
stem cell research, such as stem cells from adult tissue like bone
marrow and umbilical cord blood. These cells have repeatedly
demonstrated the capability of turning into most tissue types providing
the basis for advanced research to find cures for many diseases,
including leukemia, Parkinson's disease, juvenile diabetes, sickle cell
anemia, heart disease and spinal cord injuries. To date, we have seen
promising results coming from the research that has been conducted on
these types of cells. Doctors have successfully treated 69 diseases and
injuries using adult stem cells such as Lupus, arthritis, liver damage,
brain tumors and various forms of cancer. It is vital that we continue
to conduct important medical research and continue producing these
types of results providing hope for patients and their families.
I am very thankful for the accomplishments that have been made in
modern medicine, those of which many of us have already enjoyed or
perhaps will in the future.
However, I see the life changing results that have come from adult
stem cell research, and can't help but compare these to the lack of
results we have seen from embryonic stem cell research which has not
provided the concrete benefits to patients that we have seen otherwise.
We should not discount the possibilities surrounding the discoveries
that lie ahead within medical research, but, since we have seen results
from alternative types of stem cell research, not involving embryonic
stem cells, should we spend federal money on researching something that
has yielded few positive results?
I have seen positive results from the research we have done in the
area of adult stem cell research. In fact, an overwhelming proportion
of privately funded research is going towards adult stem cell research.
This is a strong indication of what researchers think regarding the
direction of future stem cell research. Adult stem cells and other
similar alternatives have helped thousands of patients throughout the
world, while the results of embryonic stem cell research have not
helped any one patient yet.
I have seen the proven results and lives that have benefited from the
research done on adult stem cells. It has been proven that the results
of this research have created procedures that have assisted in saving
lives, and curing illnesses. Advancements are constantly being made in
science, medical research, and technology and so this issue is
constantly changing. Just look at how far we have come in the last year
on this issue. This debate is not going to be over after this vote,
tomorrow but rather the debate is just beginning. However, at this
time, I feel that the taxpayer's money should be spent in places where
we yield the best results for patients, and currently this is in the
area of adult stem cell research.
It is my hope, Mr. President, that we continue to see monumental
steps made in medical research, stem cell and otherwise, and that we
find cures to diseases such as juvenile diabetes, cancer, sickle cell
anemia, and Alzheimer's disease.
I yield the floor.
The PRESIDING OFFICER. The Senator from Kansas is recognized.
Mr. BROWNBACK. Mr. President, I thank my colleague from Georgia for
his comments. We are about to wrap up the first full day of debate. We
will vote tomorrow on a package of three votes. This is an important
debate. This is one area that we have needed to debate for some period
of time. We haven't had a real debate on a pending bioethics bill since
1998. The science has changed dramatically since 1998 and the debate at
that point in time. We should benefit from this debate and from the
science. All of us are interested in people such as Jacki Rabon. I have
shown her picture before, but I want to make the point again because
several of my colleagues have talked about people with spinal cord
injuries. They talk about people with Parkinson's disease and what they
wanted to do was cure that--to get something that would work for them.
That is what was motivating them. I just want to help this person.
Here is a real live person; traffic accident; paraplegic from the
waist down; an active athlete; excited about her future--and that all
changed in a few seconds.
We all know this story too well because we have heard it and seen it
in our own communities. I simply ask my colleagues: What is the most
likely treatment route for her? Is it adult and cord blood stem cells
or is it embryonic stem cells? We have to make choices
[[Page S7619]]
on dollars and where you invest funds. If we take the $.5 billion that
we have invested in the embryonic stem cells in human and animals over
the last 5 years and say we are going to get people such as Jacki
walking again, what are we going to invest that money in? Is it going
to be on embryonic or adult? She is already showing some improvement
and feeling in her hip area. She is able to walk now with braces--
through use of adult stem cell therapy which, unfortunately, she has
had to go to Portugal to get. Researchers are here, but they cannot get
into the FDA trials.
Clearly, the answer, if we want her to walk again during her
lifetime, is to work and to fund adult and cord blood stem cells. That
is where we are going to get the treatments. That is where it is
working.
The other areas may provide some interesting science. But if we are
interested in helping people such as Jacki, we have one area that
works, and we have another area into which we have put $.5 billion and
it hasn't worked--and we know that.
I want to show you a picture of Dennis Turner. He has been brought up
in this debate. I have had him in to testify. He is a Parkinson's
patient. We want to cure Parkinson's disease. He was Parkinson's-free
for 5 years because of adult stem cell therapy. It started to come back
after that period of time, but he got 5 years of his life back.
If our objective is to have a treatment or cure for people such as
Dennis Turner, where are we going to put the money? Are we going to put
it in embryonic stem cells, where the scientists supporting it say this
will take decades to find any sort of treatment, if they ever find a
treatment, or put it into the adult stem cell area where they are
already showing some results?
I know if I have limited resources, I would want to put my money
where it is most likely to yield. It clearly is in the adult and cord
blood stem cell area.
A lot of allegations and questions have been made regarding adult
stem cells and cord blood and whether they are actually showing the
types of results that I have been suggesting.
I ask unanimous consent to have printed in the Record at the end of
my statement the current list--it gets updated often--of 72 current
human clinical applications using adult stem cells.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Mr. BROWNBACK. Mr. President, next week it will may be 75, but for
this week it is 72.
My point in saying highlighting this is that some have said they
really question whether we are getting that many treatments. There have
only been nine FDA-approved full clinical trials, full treatment areas
using adult stem cells. Okay. I will take that. I do not know if that
is an accurate number. But remember that FDA is the standard where you
have to go through clinical trials 1 and 2 to get the application and
get it tested before it is fully used.
I note that people are challenging how many areas of adult stem cell
are being treated. I welcome this debate. I think we should be looking
at the science and where it is going. They were saying we really
question whether this many areas of adult stem cell treatments are
actually happening. They produced an addendum to their challenge on it.
They went through all of the 65 areas at that time. It is now 72. But
when they did the review, it was 65. The Senator from Iowa was
particularly challenging whether we have this many treatment areas. He
pulled out one on testicular cancer and said: I don't think they are
really getting it there. But this addendum is the people challenging
the number of adult stem cell areas that have treatment. On testicular
cancer, the researcher described a clinical evaluation showing improved
long-term survival of a relapsed testicular cancer patient following
the radical therapy that included a transplant of adult stem cells from
bone marrow or blood. The research is actually showing that it was an
improvement.
I am not saying that these are all FDA-approved areas. This is an
area of research. But you actually have a researcher saying it showed
improvement. This isn't the group who is challenging whether we are
getting these treatments at all. They are not cures today. This is
research. But the research shows a promise even in the area that they
challenge.
Leukemia--this is from the same addendum. Two clinical studies, each
incorporating multiple leukemia types, indicate that adult stem cell
transplants from bone marrow or umbilical cord blood improved the
survival of children with leukemia.
That is not FDA approved. But it is working. This, after only a short
period of time that we have been working with all these different types
of adult stem cells. We have known about them in bone marrow for some
period of time.
Some patients with Hodgkin's lymphoma show an overall improved
survival rate when transplanted with adult stem cells from blood.
The list goes on and on.
I welcome a debate about whether we are getting treatment for areas
where people are showing improvement taking place with adult and cord
blood because the truth of matter is we are. These are not all FDA
approved. We never said that they were. The problem is we need more
money to be able to get more of these FDA trials so that we can get
more people treated. If we do that, there is a very promising area that
is already showing results. Why not put your money there?
Let me give my colleagues a visual of this, if anybody is interested.
There is a notebook of showing the accumulation of recent advances in
adult stem cell research and other alternatives to cloning and
embryonic stem cell research. This is a one-page summary of each of
these areas where we are getting treatment. Note that I am not saying
cures. I want to be very careful with my words. The treatments are
promising in adult and cord blood.
Look how thick this book is. This is just one-page summaries of each
of these various areas--cord blood, cartilage, brain damage, cancers.
It has been very impressive.
If you do not like this example or if you are still questioning
whether we are showing this much progress in adult stem cell, I invite
people to go on the Internet and look at a site called
ClinicalTrials.gov. This is an area where clinical trials are listed on
the Internet. I didn't know about it until today. It sounded very
interesting to me. It shows, as of now--I guess these numbers are
actually growing with 565 such clinical trials currently active or
recruiting patients using adult or cord blood stem cells to treat
people.
If we want to cure people, if we want to find real treatments, if we
want to see cures for people with spinal cord injuries, Parkinson's,
diabetes, cancer or heart disease, the clear area to invest in is adult
and cord blood. That is the clear area to go into.
Let us look on the other side of the aisle on this the embryonic stem
cell work which is being pushed here today.
By the way, my colleagues have known about this for a very long time.
We have known about embryonic stem cells for 25 years. We have worked
and looked at these things for a long period of time.
They say this is arbitrary and it is not going to support killing
embryos. What is being talked about is using taxpayer money to expand
the lines of embryonic stem cell research. To get embryonic stem cells,
you have to destroy an embryo.
The President set a date, August 9 at 9 p.m, when he was delivering a
speech to the Nation saying, after this point in time, we are not going
to fund it any further because we do not want to fund the additional
destruction of human life. We will work on it on a prior date. That is
why that date was picked.
Here is a clear demarcation. We will fund it prior; we have to the
tune of half a billion on human and animal. It is both. After that, we
will not fund it on humans because the life-and-death decision has
already been made on these designs prior to August 9 but not on future
ones.
Now, if we say we are going to use taxpayer money to fund any human
embryonic stem cell research, people could go out today after we fund
this, destroy human embryos, develop the lines, and have Federal
taxpayer dollars. I again point out to my colleagues, there are no
prohibitions in the United States today against any embryonic stem cell
research. You can do it anywhere you want. We do have a
[[Page S7620]]
limitation on the Federal taxpayer dollars, on where they can go in the
future destruction of human life.
Now, with this half a billion that we have invested over the last 5
years, how many human treatments do we have from embryonic stem cells?
I have a notebook that shows the number of human treatments. I will
show this notebook again. This is adult and cord blood. Here are human
treatments on embryonic stem cell research. We do not have the
research. It is not there. They do not exist.
It is interesting research. It has proven very problematic to get to
people.
A number of my colleagues have been pushing this bill for some period
of time, and I do not question or challenge what they were doing. I
think they want to find cures. But the problem is we have not found
treatments in the embryonic field.
They were saying in the year 1999 one of my colleague's medical
experts testified that it may well be within 5 years of a cure for
Parkinson's disease, Alzheimer's, and a long list of other human
ailments. Stem cell research has enormous potential.
That is true. But it is adult cord blood stem cell research that is
working. It is not embryonic. The embryonic has not produced the
treatments. That was 1999. We are 7 years later, and it has not
produced a peer-reviewed treatment.
We have scientists who testified at a hearing in 1998. Mr. President,
I refer my colleagues to www.access.gpo.gov/congress/senate for that
testimony.
Mr. President, when Dr. Gearhart was asked how long will it be before
we get these cures to Parkinson's, Alzheimer's, or cancer, he
responded:
I actually think within several years, to be honest with
you . . .
That was 1998. Eight years later, here we are. Dr. Gearhart--one of
the leading researchers in this field.
Then Dr. Thompson, one of the leading researchers on Parkinson's:
I am going to say 5 to 10 years more.
It will be one of the first ones.
We do have a treatment being developed. And it is adult stem cells
for Parkinson's. We do not need to make this life-and-death decision
and expand taxpayer funding for the embryonic lines.
My point is, in 1998 the leading researchers were saying we will have
these cures in a few years, 5 to 10 years, and now researchers are
saying it is decades, if even in their lifetime, that it will happen.
I conclude with this point. If this were all in the abstract and we
were saying that we will spend another half a billion in this area, go
ahead and do that, you could say: Well, all right, we spend a lot of
money around here, we will do that. The problem with it is: how many
millions of dollars will be spent on research, which is based on
destroying human embryos that become human people? This is the
beginnings of human life. That is the real ethical rub on top of the
financial rub of whether this is the right place to invest.
I have cited the snowflake child, Hannah previously. Was she just a
clump of stem cells? Early life can be very fragile.
This is Isaiah Royal, born to one of my staff members. Isaiah Royal
was born at 24 weeks of age, very early. He is a fighter. But I don't
think you can possibly say he is not human life. He is just 23 weeks
after the embryonic stage that we are talking about, 23 weeks and a
couple of days after that. Would you deny that he is human life? You
would say no, of course not. Isaiah is struggling. He weighed 1 pound
14 ounces at birth. He is a good, tough, fighter. But we are talking
about fragile human life, and it should be treated as sacred. We should
not do research on it. Human life is important.
This is an important question. I urge my colleagues to vote against
H.R. 810.
Exhibit I
72 Current Human Clinical Applications Using Adult Stem Cells
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 hemoglobin).
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.
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 adrenoleukodystrophy.
Mr. BROWNBACK. I yield to my colleague from Virginia who is here to
speak on some important topics.
The PRESIDING OFFICER. The Senator from Virginia.
Mr. WARNER. Mr. President, I thank my distinguished colleague. We
have another distinguished colleague here. It is my understanding that
at 8 o'clock, the time of the distinguished Senator from Kansas now
shifts to the other side of the aisle, but my colleague said he only
wants 3 or 4 minutes.
Mr. BROWNBACK. I have other things I can cover. I understand the
distinguished Senator from Virginia wanted to come over and speak on a
very pressing matter of foreign policy. That is why I yielded the time
to my colleague.
Mr. WARNER. I will try to compress my time in 10 minutes.
Mr. BROWNBACK. Good.
If I could, what does the Senator from Iowa desire?
[[Page S7621]]
Mr. HARKIN. If the Senator would yield, I understand the Senator from
Virginia wanted 10 minutes. I said I didn't intend to speak for half an
hour; I just wanted to speak for about 5 minutes at 8 o'clock and yield
back the remainder of my time and he could speak as long as he wanted
to at that time. It is only 15 minutes from now. I thought the Senator
from Kansas was probably going to use up most of the time.
Mr. BROWNBACK. I was. But I understood that my colleague wanted to
speak on this particular issue. If the Senator wants to summarize and
my colleague from Virginia wants to wait, I was offering him that
courtesy because he had discussed coming over here early to do that.
Mr. WARNER. I am here to accommodate all.
Would the Senator like to finish his remarks?
Mr. HARKIN. I say to the Senator from Virginia, go ahead and take
your time. I will speak later. That is fine.
(The remarks of Mr. Warner are printed in today's Record under
``Morning Business.'')
Ms. COLLINS. Mr. President, as a long-time supporter of stem cell
research, I want to commend the majority leader for working out an
agreement that will give the Senate the opportunity to act on this
critically important issue.
I am particularly pleased that the Senate will finally have the
opportunity to vote on the Stem Cell Research Enhancement Act. I am
proud to be a cosponsor of this bipartisan bill which will expand the
number of stem cell lines that are eligible for federally funded
research, enabling scientists to take full advantage of the scientific
and medical opportunities provided by stem cells. At the same time, it
establishes standards and creates a framework to ensure that this
research is conducted ethically.
The promise of embryonic Stem cell lines lies with their potential to
develop into virtually any cell, tissue, or organ in the body. As a
consequence, this research holds considerable potential to treat and
even cure a vast array of diseases and conditions. Researchers could,
for example, potentially generate insulin-producing islet cells for
patients with juvenile diabetes; neurons to treat Parkinson's disease,
ALS, and Alzheimer's disease; as well as bone marrow cells to treat
cancer. It is estimated that more than 100 million Americans are
currently afflicted by diseases or disabilities that have the potential
to be treated through this research.
On August 9, 2001, President Bush announced that Federal funds could,
for the first time, be used to support research on embryonic stem
cells. This research, however, was limited to existing embryonic stem
cell lines created prior to 9 p.m. on that day.
In the 4 years since the President made that announcement, this stem
cell policy has fallen far short of its original goals. While the Human
Embryonic Stem Cell Registry at the NIH lists 78 stem cell lines, at
best, no more than 212 lines will ever be available for research under
the current policy.
Moreover, as Dr. John Gearhart of Johns Hopkins University told the
Special Committee on Aging last year, existing lines are ``contaminated
with animal cells, lack genetic diversity, are not disease-specific and
are not adequate for researchers to apply to a wide variety of
diseases.'' Limiting researchers to these lines therefore places huge
and unnecessary roadblocks in the way of possible treatments and cures
for devastating diseases like Alzheimer's disease, ALS, cancer and
diabetes.
We have learned a lot about stem cells since 2001. For example,
scientists have now crated methods for growing stem cell lines that are
free of animal cells, greatly improving their potential for treating
and curing disease. They have also created ``disease specific'' stem
cell lines. Under the current policy, however, these ``new and
improved'' stem cell lines are not available to federally funded
researchers in the United States.
It is therefore time for us to update our stem cell policy to reflect
what we have learned so that we can accelerate this important research,
which hold such promise for millions of Americans and their families.
The Stem Cell Research Enhancement Act lifts the current restriction
so that stem cell lines are eligible for federally funded research
regardless of the date on which they were created. Federal funding,
however, would continue to be restricted to stem cells derived from
embryos originally created for fertility treatments that are in excess
of the clinical need and that otherwise would be discarded.
The legislation also requires the informed consent of the donors and
prohibits any financial inducement to donate. Finally, the bill calls
on the National Institutes of Health to develop strict guidelines to
ensure that researchers adhere to clear ethical and moral standards.
As the founder and co-chair of the Senate Diabetes Caucus, I am
particularly excited about the promise that stem cell research holds
for a cure for diabetes. Early research has shown that stem cells have
the potential to develop into insulin-producing cells to replace those
that have been destroyed in people with type I diabetes.
Last year, I chaired a hearing in conjunction with the Juvenile
Diabetes Research Foundation's Children's Congress to examine the
devastating impact that juvenile diabetes has had on American children
and their families. We heard heartbreaking testimony from children who
had traveled to Washington to tell Congress what it is like to have
diabetes, just how serious it is, and how important it is that we fund
the research necessary to find a cure.
Steffi Rothweiler from Falmouth, ME, told the committee that she
actually couldn't remember having a normal life without nights and
weekends, and every hour of every day to take care of diabetes. She
told us about her parents, who have given up their nights and weekends,
and every hour of every day to take care of her and make sure that she
stays in tight control of her blood sugar levels so that she can stay
as healthy as possible. Steffi asked that we do all that we can to find
a cure for diabetes as quickly as possible. We simply cannot ignore the
potential that embryonic stem cell research holds for wonderful young
people like Steffi.
I am sensitive to the ethical concerns raised by opponents of this
research. That is why I have cosponsored the legislation introduced by
Senators Santorum and Specter to encourage the development of
alternative methods for deriving stem cells without using embryos.
The fact is, however, that the embryos that will be used for this
research would otherwise be discarded. In my view, the ethical choice
is to use them for research that may benefit millions of Americans
rather than discard them as medical waste.
Moreover, what is often ignored in this debate is that embryonic stem
cell research is occurring in the private sector, where it is outside
the purview of the NIH. It therefore lacks the scientific and ethical
oversight that routinely occurs with federally funded research. Dr.
Allen Spiegel, who was then the Director of the National Institute of
Diabetes anti Digestive and Kidney Diseases, testified at our
Children's Congress hearing last year. He told the committee that,
while NIH routinely works very closely with the private sector, in the
area of stem cell research, ``there is a wall.'' By expanding our
current stem cell policy, we are tearing down that wall, allowing more
research but with clear ethical standards.
Opponents of embryonic stem cell research contend that adult stem
cells derived from tissue, such as bone marrow, are a sufficient
replacement for embryonic stem cells in forwarding this important
research. I believe that we need both. But, as Dr. Speigel told our
committee, with regard to diabetes research:
We need to do embryonic stem cell first because it can give
us a better understanding of what causes Type I diabetes . .
. because it will actually inform our ability to work with
adult stem cells . . . and finally, because, and one cannot
guarantee or promise this, the embryonic stem cells
themselves, if successfully turned into insulin-secreting
beta cells, could be the source of cell therapy.
Mr. President, I believe that it would be tragic not to take
advantage of this opportunity to accelerate research that can
potentially help millions of people. I therefore urge my colleagues to
join me in voting for the Stem Cell Research Enhancement Act.
[[Page S7622]]
The PRESIDING OFFICER. The Senator from Iowa.
Mr. HARKIN. Mr. President, I will not take the entire 25 minutes that
are left, but I did want to close out a little bit today before we
proceed into tomorrow by just responding to a few of the things that
were said today to try to clear up a couple of issues.
The Senator from Kansas, my good friend, was going on and on about
stem cells, as he has most of the day, and about how all these
treatments and everything are out there. I could respond to every one
of them, but I think what we have to keep in mind is that if all of
these diseases that the Senator from Kansas talked about have been
treated with adult stem cells, how come all of the patient advocacy
groups for these diseases support H.R. 810?
One has to wonder, when you listen to the Senator from Kansas outline
all these diseases that are being helped by adult stem cells. He brings
up the picture of the guy who had Parkinson's. He was helped with adult
stem cells. But, again, he has now gone back and he is where he was
before.
Well, if adult stem cells are doing so much, why is the Parkinson's
group, the Parkinson's Action Network, supporting H.R. 810? Why are all
these advocacy groups supporting H.R. 810 if adult stem cells are so
great? Are they just a bunch of stupid people out there? Have they been
hoodwinked and misguided?
These advocacy groups know. They know what is going on. And they know
that S. 2754 is no substitute for H.R. 810. While adult stem cells are
fine, as I pointed out earlier, they have been investigating and doing
science on adult stem cells for over 30 years.
Now, just another little thing that happened: The Senator from
Kansas, I heard him say: Well, they have been investigating animal stem
cells for 20 years.
That might lead you to think: Well, we have been looking at stem
cells for 20 years. Not so. We never derived human embryonic stem cells
until 1998--8 years ago. So I wanted to make the record clear on that.
Now, the Senator also mentioned something about testicular cancer. He
made all kinds of claims about adult stem cells helping testicular
cancer. Let me read from a letter written by Craig Nichols, MD, a
member of the board of the Lance Armstrong Foundation. We all know the
Lance Armstrong Foundation is basically focused on testicular cancer
because that is what Lance Armstrong had. And he licked it. But let me
quote from the letter written on July 14:
Dear Senator Frist:
As a member of the Lance Armstrong Foundation's Board of
Directors, I am writing in response to assertions that adult
stem cells have treated or cured the disease of testicular
cancer. . . . I feel that it is important to set the record
straight on this issue.
Testicular cancer is the most common cancer among men ages
15-35 and approximately 8,000 men will be diagnosed with
testicular cancer in the United States this year. While
testicular cancer is one of the most curable forms of cancer,
our organization would like to emphasize as the Senate
debates H.R. 810 . . . that we have NOT completely eradicated
the disease.
There is not an FDA-approved adult stem cell treatment
generally available to treat testicular cancer.
The Senator from Kansas kind of, in his comments, led us to think
that there might be. Here is what Dr. Nichols said:
Rather, adult stem cells enable testicular cancer patients
to withstand a higher dose of chemotherapy during treatment
for the disease.
The adult stem cells enable patients to withstand a higher dose of
chemotherapy. Dr. Nichols says:
We support exploring every avenue of research, including
embryonic stem cell research within specified ethical limits,
until a cure is found. . . .
The Lance Armstrong Foundation asks that you and your
colleagues pass H.R. 810, and not accept any substitutes.
I ask unanimous consent that this letter from the Lance Armstrong
Foundation be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Lance Armstrong Foundation,
Austin, TX, July 14, 2006.
Hon. William Frist,
Majority Leader, U.S. Senate,
Washington, DC.
Dear Senator Frist: As a member of the Lance Armstrong
Foundation's (LAF) Board of Directors, I am writing in
response to assertions that adult stem cells have treated or
cured the disease of testicular cancer. While the mission of
the LAF is to inspire and empower people affected by ALL
types of cancer, I feel that it is important to set the
record straight on this issue.
Testicular cancer is the most common cancer among men ages
15-35 and approximately 8,000 men will be diagnosed with
testicular cancer in the United States this year. While
testicular cancer is one of the most curable forms of cancer,
our organization would like to emphasize as the Senate
debates H.R. 810, the Stem Cell Research and Enhancement Act,
that we have NOT completely eradicated the disease.
There is not an FDA-approved adult stem cell treatment
generally available to treat testicular cancer. Rather, adult
stem cells enable testicular cancer patients to withstand a
higher dose of chemotherapy during treatment for the disease.
We support exploring every avenue of research, including
embryonic stem cell research within specified ethical limits,
until a cure is found. The most respected scientists in our
field view embryonic stem cells as an area of research that
must be explored, and one that our government must make a
commitment to support. The Lance Armstrong Foundation asks
that you and your colleagues pass H.R. 810, and not accept
any substitutes.
Sincerely,
Craig Nichols, M.D.,
Member of the Board,
Lance Armstrong Foundation.
Mr. HARKIN. Now, we hear claims that leukemia and lymphomas have been
cured or treated by adult stem cells. Here is what George Dahlman of
the Leukemia and Lymphoma Society has to say about that:
On behalf of the Leukemia and Lymphoma Society, I am
writing in response to assertions that adult stem cells have
treated or cured several blood cancers, including several
leukemias, lymphomas and multiple myeloma.
As a representative of more than 700,000 patients and their
caregivers in this country that battle blood cancers on a
daily basis, our organization would like to emphasize, as the
Senate debates H.R. 810 . . . that we exist today because we
have not found cures for these devastating diseases. . . .
the claim that treatment of blood cancers with cord blood,
blood or marrow stem cells--known as hematopoietic stem
cells--demonstrates a potential of ``adult stem cell''
research or is a substitute of embryonic stem cell research
is misleading and disingenuous.
Again, this says that the claim that treatment of blood cancer with
marrow stem cells demonstrates that adult stem cells is a substitute is
misleading and disingenuous.
Mr. Dahlman concludes:
The Leukemia and Lymphoma Society asks that you and your
colleagues pass H.R. 810, and not accept any substitutes.
Mr. President, we have heard a lot of talk about these embryos and
that we all started as a dot. I have often used this example. I have
said: What is an embryo? I have often put a dot on a piece of paper and
held it up for audiences to see and said that is what we are talking
about. It is that big, the size of a period at the end of a sentence.
That is not to diminish the importance of an embryo. But I use it in
comparison. An embryo at the blastocyst stage has between 100 and 200
cells. That embryo we are talking about that is in an in vitro
fertilization clinic and frozen in liquid nitrogen will never become a
human being unless and until it is implanted into a uterus and it takes
hold and develops. Sometimes they are implanted and they don't take
hold and they are discharged. So an embryo is potential life--potential
in that if it is implanted and takes hold, it could become a human
being. It is potential life.
Look at this photo of Lauren Stanford. She says:
I am so happy to hear that the Senate is thinking of
passing H.R. 810. I can dream again--dream of that great day
when I write a thank you letter to the Senate, the House, and
everyone who helped me become just another girl; a girl who
dreamed and hoped and one day got just what she wanted; her
health and future.
Lauren Stanford has diabetes. She knows what will happen if she is
not cured. At some point in her life, she will probably become blind.
At some point in her life, she will probably lose a foot, a leg, one or
more of her limbs. At some point in her life, diabetes will take her.
Lauren Stanford. I don't know her. I don't know that I ever met Lauren
Stanford. This is not potential life; this is real life. This is a
human being who is living right now.
That dot on the paper is an embryo. Is it alive? Of course it is
alive. Is it a human being? No. It is potential life. Lauren Stanford
is real life.
Read the bill. Read H.R. 810. Ethical guidelines. We can only use
those embryos that are left over from in vitro
[[Page S7623]]
fertilization that are going to be discarded. Read the bill:
Prior to the consideration of embryo donation and through
consultation with the individuals seeking fertility
treatment, it was determined that the embryos would never be
implanted in a woman and would otherwise be discarded.
Written consent.
The individuals seeking fertility treatment donated the
embryos with written informed consent and without receiving
any financial or other inducements to make the donation.
It has to be determined, before any embryo could ever be used for
stem cell derivation, that the embryos would never be implanted in a
woman and would otherwise be discarded. Every day, fertility clinics
discard unwanted embryos. People have IVF--50,000 babies were born last
year to couples who wanted to have a baby and could not and needed IVF.
But some embryos were left over. Well, couples who have had their
children then call up the clinic or the clinic calls them and the
clinic says: Do you want to continue to pay for us to keep these
embryos frozen?
If you have had your children and you don't want to expand your
family, you say: No, I don't want to pay for that anymore. Guess what.
The IVF clinic discards it. I have heard they basically throw them in
the sink and wash them down the sink. They are only as big as a period
at the end of a sentence.
So the real question for us really comes down to that, unless we want
to outlaw in vitro fertilization and make it a crime, which I don't
hear anybody here wanting to do. As long as we have in vitro
fertilization and have leftover embryos, the real question for us is
this: If the donors of those embryos, through written informed consent,
determine it will never be implanted in a woman and will be discarded,
is it better to have them discarded and flushed down the drain or used
for the kind of scientific research that will cure Lauren Stanford of
her diabetes? Potential life versus real life. Potential life that will
be discarded versus real life. Potential life that will be flushed down
the drain versus Lauren Stanford, real life. That is the question for
us.
We hear all of these arguments around here about we were all an
embryo at one time. Of course we were. The question is, What happens to
all those embryos? Right now, they are being discarded, and it is
perfectly legal to do so. I don't see anyone here with legislation
saying it is going to be a crime for them to be discarded, a crime to
have in vitro fertilization. Really, that is the choice. Do we discard
potential life or do we use it to save real life? This is not potential
life, this is real.
My nephew Kelly, who suffered a tragic accident on an aircraft
carrier 27 years ago, hasn't walked since. He keeps hope alive that one
day he will walk again. He knows about the research that has been done
on rats and mice where spinal cords have been reconnected using
embryonic stem cells. He knows that. I have never heard him say it, but
I suppose he would probably echo what Christopher Reeve once said: Oh,
to be a rat.
He knows that. That is real life. Kelly is a real person. He is
alive. He is not potential life. That is our decision when we face the
vote tomorrow on H.R. 810.
So all these other arguments about adult stem cells and this kind of
stuff, fine, I have nothing against adult stem cell research. I am in
favor of it. We ought to keep it going. But to choke off--not what I
say but what the leading scientists say, the leading Nobel Prize
winners say, what all of these disease groups who have medical people
sitting on their boards, what they all say is the most promising avenue
of research for curing Alzheimer's, juvenile diabetes, spinal cord
injuries, Parkinson's, and ALS, the most promising is not adult stem
cells. It is embryonic stem cells. That is what they say, not me.
To cut that off and to say, no, we won't do it is telling Lauren
Stanford that potential life, that an embryo the size of a pencil dot,
yes, is life; it is human potential that is as important as she is;
that they have equal weight on the scales. I am sorry, Mr. President, I
don't think so, not when it is going to be discarded, legally thrown
down the drain. And as long as we have strict ethical guidelines in the
bill--strict ethical guidelines, more than exists right now, stronger
ethical guidelines than are in the law right now.
To me, there is really only one answer. We should be in favor of this
real life of curing diseases, seeking treatments and cures in an
ethical manner, which is what this bill does. So I hope that tomorrow
we have an overwhelming vote in favor of H.R. 810.
I understand today the administration came out with a Statement of
Administration Policy, or SAP as it is called around here, saying the
President would veto it. I hope the President rethinks this. He is
overseas anyway. Let's face it, we are all kind of captives of our
staff around here. Staff tells us this and that. OMB says this, OMB
says that. I am hopeful this is the work of some staff, that the
President hasn't thought about it. He has been overseas focused on the
G8; now, I am sure, focused on the Middle East.
I hope when President Bush thinks about it that he remembers Lauren
Stanford, that he will remember the letter from Nancy Reagan and he
will come down on the side of real life, and he will come down on the
side of an ethical approach to embryonic stem cell research.
I still believe in miracles, and I hope a miracle will occur and the
President of the United States finds it in his heart to say that what
he did on August 9, 2001, was done with a lack of adequate knowledge.
He can say: Look, we thought there were 78 lines, and there were not;
there were only 21 lines. We didn't know they were all contaminated
with mouse feeder cells. They can't be used for human therapies. That
he will say in light of all that we know now, and with the strict
ethical guidelines we have in this bill, I see fit to sign into law
H.R. 810.
That is my hope. That is the hope of Lauren Stanford. That is the
hope of the millions of Americans out there who suffer from
Alzheimer's, the millions who suffer from spinal cord injuries and
their families and caregivers and Parkinson's and ALS, and so many
more.
Tonight they are praying--they are praying--that a miracle occurs and
that the President will change his mind and sign this bill. And until
the very moment that he vetoes it, I will remain hopeful that miracle
will occur.
Mr. President, I yield the floor and suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. FRIST. Mr. President, I ask unanimous consent the order for the
quorum call be rescinded.
The PRESIDING OFFICER. Without objection, so ordered.
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