[Congressional Record Volume 151, Number 106 (Friday, July 29, 2005)]
[Senate]
[Pages S9323-S9330]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
DEPARTMENT OF THE INTERIOR, ENVIRONMENT, AND RELATED AGENCIES
APPROPRIATIONS ACT, 2006--CONFERENCE REPORT
The PRESIDENT pro tempore. Under the previous order, the Senate will
proceed to the consideration of the conference report to accompany H.R.
2361, which the clerk will report.
The legislative clerk read as follows:
The committee of conference on the disagreeing votes of the
two Houses on the amendment of the Senate to the bill (H.R.
2361) making appropriations for the Department of the
Interior, environment, and related agencies for the fiscal
year ending September 30, 2006, and for other purposes,
having met, have agreed that the House recede from its
disagreement to the amendment of the Senate and agree to the
same with an amendment, and the Senate agree to the same,
signed by a majority of the conferees on the part of both
Houses.
(The conference report is printed in the House proceedings of the
Record of July 28, 2005.)
Recognition of the Majority Leader
The PRESIDENT pro tempore. The majority leader is recognized.
Schedule
Mr. FRIST. Mr. President, we have several unanimous consent requests
with respect to our schedule today. Following the time for the two
leaders, we will consider the Interior appropriations conference report
under a 20-minute time limit. Following that debate, we will return to
the energy conference report for final closing remarks. At the
conclusion of that debate, we will have a series of rollcall votes on
these measures. I would anticipate those votes occurring sometime
around 10:45 or so this morning.
After those votes are completed, we will return to the gun
manufacturers liability bill. We have an agreement for a limited number
of amendments, with time agreements on each of those. Therefore, we
will have votes throughout the afternoon until passage of that
legislation.
Finally, we will also consider the highway conference report when it
becomes available from the House. It is not yet here. All Senators
should be aware that we will have a substantial number of rollcall
votes today, as many as 13 over the course of the day. Therefore, we
ask that Senators remain close to the Chamber throughout the day to
facilitate the votes and our remaining business.
Vitiation of Unanimous-Consent Agreement--H.R. 2985
Mr. FRIST. Mr. President, I ask unanimous consent that the order with
respect to the Legislative branch appropriations conference report be
vitiated.
The PRESIDENT pro tempore. Without objection, it is so ordered.
The PRESIDENT pro tempore. The majority leader is recognized.
stem cell research
Mr. FRIST. Mr. President, since 2001 when stem cell research first
captured our Nation's attention, I have said many times the issue will
have to be reviewed on an ongoing basis--and not just because the
science holds tremendous promise, or because it is developing with
breathtaking speed. Indeed, stem cell research presents the first major
moral and ethical challenge to biomedical research in the 21st century.
In this age of unprecedented discovery, challenges that arise from
the nexus of advancing science and ethical considerations will come
with increasing frequency. How can they not? Every day we unlock more
of the mysteries of human life and more ways to promote and enhance our
health. This compels profound questions--moral questions that we
understandably struggle with both as individuals and as a body politic.
How we answer these questions today--and whether, in the end, we get
them right--impacts the promise not only of current research, but of
future research, as well. It will define us as a
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civilized and ethical society forever in the eyes of history. We are,
after all, laying the foundation of an age in human history that will
touch our individual lives far more intimately than the Information Age
and even the Industrial Age before it.
Answering fundamental questions about human life is seldom easy. For
example, to realize the promise of my own field of heart
transplantation and at the same time address moral concerns introduced
by new science, we had to ask the question: How do we define ``death?''
With time, careful thought, and a lot of courage from people who
believed in the promise of transplant medicine, but also understood the
absolute necessity for a proper ethical framework, we answered that
question, allowed the science to advance, and have since saved tens of
thousands of lives.
So when I remove the human heart from someone who is brain dead, and
I place it in the chest of someone whose heart is failing to give them
new life, I do so within an ethical construct that honors dignity of
life and respect for the individual.
Like transplantation, if we can answer the moral and ethical
questions about stem cell research, I believe we will have the
opportunity to save many lives and make countless other lives more
fulfilling. That is why we must get our stem cell policy right--
scientifically and ethically. And that is why I stand on the floor of
the U.S. Senate today.
Four years ago, I came to this floor and laid out a comprehensive
proposal to promote stem cell research within a thorough framework of
ethics. I proposed 10 specific interdependent principles. They dealt
with all types of stem cell research, including adult and embryonic
stem cells.
As we know, adult stem cell research is not controversial on ethical
grounds--while embryonic stem cell research is. Right now, to derive
embryonic stem cells, an embryo--which many, including myself, consider
nascent human life--must be destroyed. But I also strongly believe--as
do countless other scientists, clinicians, and doctors--that embryonic
stem cells uniquely hold specific promise for some therapies and
potential cures that adult stem cells cannot provide.
I will come back to that later. Right now, though, let me say this: I
believe today--as I believed and stated in 2001, prior to the
establishment of current policy--that the Federal Government should
fund embryonic stem cell research. And as I said 4 years ago, we should
Federally fund research only on embryonic stem cells derived from
blastocysts leftover from fertility therapy, which will not be
implanted or adopted but instead are otherwise destined by the parents
with absolute certainty to be discarded and destroyed.
Let me read to you my fifth principle as I presented it on this floor
4 years ago: No. 5. Provide funding for embryonic stem cell research
only from blastocysts that would otherwise be discarded. We need to
allow Federal funding for research using only those embryonic stem
cells derived from blastocysts that are left over after in vitro
fertilization and would otherwise be discarded (Cong. Rec. 18 July
2001: S7847).
I made it clear at the time, and do so again today, that such funding
should only be provided within a system of comprehensive ethical
oversight. Federally funded embryonic research should be allowed only
with transparent and fully informed consent of the parents. And that
consent should be granted under a careful and thorough Federal
regulatory system, which considers both science and ethics. Such a
comprehensive ethical system, I believe, is absolutely essential. Only
with strict safeguards, public accountability, and complete
transparency will we ensure that this new, evolving research unfolds
within accepted ethical bounds.
My comprehensive set of 10 principles, as outlined in 2001 (Cong.
Rec. 18 July 2001: S7846-S7851) are as follows: (1) ban embryo creation
for research; (2) continue funding ban on derivation; (3) ban human
cloning; (4) increase adult stem cell research funding; (5) providing
funding for embryonic stem cell research only from blastocysts that
would otherwise be discarded; (6) require a rigorous informed consent
process; (7) limit number of stem cell lines; (8) establish a strong
public research oversight system; (9) require ongoing, independent
scientific and ethical review; (10) strengthen and harmonize fetal
tissue research restrictions.
That is what I said 4 years ago, and that is what I believe today.
After all, principles are meant to stand the test of time--even when
applied to a field changing as rapidly as stem cell research.
I am a physician. My profession is healing. I have devoted my life to
attending to the needs of the sick and suffering and to promoting
health and well being. For the past several years I have temporarily
set aside the profession of medicine to participate in public policy
with a continued commitment to heal.
In all forms of stem cell research, I see today, just as I saw in
2001, great promise to heal. Whether it is diabetes, Parkinson's
disease, heart disease, Lou Gehrig's disease, or spinal cord injuries,
stem cells offer hope for treatment that other lines of research cannot
offer.
Embryonic stem cells have specific properties that make them uniquely
powerful and deserving of special attention in the realm of medical
science. These special properties explain why scientists and physicians
feel so strongly about support of embryonic as well as adult stem cell
research.
Unlike other stem cells, embryonic stem cells are ``pluripotent.''
That means they have the capacity to become any type of tissue in the
human body. Moreover, they are capable of renewing themselves and
replicating themselves over and over again--indefinitely.
Adult stem cells meet certain medical needs. But embryonic stem
cells--because of these unique characteristics--meet other medical
needs that simply cannot be met today by adult stem cells. They
especially offer hope for treating a range of diseases that require
tissue to regenerate or restore function.
On August 9, 2001, shortly after I outlined my principles (Cong. Rec.
18 July 2001: S7846-S7851), President Bush announced his policy on
embryonic stem cell research. His policy was fully consistent with my
ten principles, so I strongly supported it. It federally funded
embryonic stem cell research for the first time. It did so within an
ethical framework. And it showed respect for human life.
But this policy restricted embryonic stem cell funding only to those
cell lines that had been derived from embryos before the date of his
announcement. In my policy I, too, proposed restricting number of cell
lines, but I did not propose a specific cutoff date. Over time, with a
limited number of cell lines, would we be able to realize the full
promise of embryonic stem cell research?
When the President announced his policy, it was widely believed that
78 embryonic stem cell lines would be available for Federal funding.
That has proven not to be the case. Today only 22 lines are eligible.
Moreover, those lines unexpectedly after several generations are
starting to become less stable and less replicative than initially
thought; they are acquiring and losing chromosomes, losing the normal
karyotype, and potentially losing growth control. They also were grown
on mouse feeder cells, which we have learned since, will likely limit
their future potential for clinical therapy in humans (e.g., potential
of viral contamination).
While human embryonic stem cell research is still at a very early
stage, the limitations put in place in 2001 will, over time, slow our
ability to bring potential new treatments for certain diseases.
Therefore, I believe the President's policy should be modified. We
should expand federal funding--and thus NIH oversight--and current
guidelines governing stem cell research, carefully and thoughtfully
staying within ethical bounds.
During the past several weeks, I have made considerable effort to
bring the debate on stem cell research to the Senate floor, in a way
that provided colleagues with an opportunity to express their views on
this issue and vote on proposals that reflected those views. While we
have not yet reached consensus on how to proceed, the Senate will
likely consider the Stem Cell Research Enhancement Act, which passed
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the House in May by a vote of 238 to 194, at some point this Congress.
This bill would allow Federal funding of embryonic stem cell research
for cells derived from human embryos that: (1) are created for the
purpose of fertility treatments; (2) are no longer needed by those who
received the treatments; (3) would otherwise be discarded and
destroyed; (4) are donated for research with the written, informed
consent of those who received the fertility treatments, but do not
receive financial or other incentives for their donations.
The bill, as written, has significant shortcomings, which I believe
must be addressed.
First, it lacks a strong ethical and scientific oversight mechanism.
One example we should look to is the Recombinant DNA Advisory
Committee--RAC--that oversees DNA research. The RAC was established 25
years ago in response to public concerns about the safety of
manipulation of genetic material through recombinant DNA techniques.
Compliance with the guidelines--developed and reviewed by this
oversight board of scientists, ethicists, and public representatives--
is mandatory for investigators receiving NIH funds for research
involving recombinant DNA.
Because most embryonic stem cell research today is being performed by
the private sector--without NIH Federal funding--there is today a lack
of ethical and scientific oversight that routinely accompanies NIH-
Federal funded research.
Second, the bill doesn't prohibit financial or other incentives
between scientists and fertility clinics. Could such incentives, in the
end, influence the decisions of parents seeking fertility treatments?
This bill could seriously undermine the sanctity of the informed
consent process.
Third, the bill doesn't 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. Obviously, any decision about the
destiny of an embryo must clearly and ultimately rest with the parents.
These shortcomings merit a thoughtful and thorough rewrite of the
bill. But as insufficient as the bill is, it is fundamentally
consistent with the principles I laid out more than four years ago.
Thus, with appropriate reservations, I will support the Stem Cell
Research Enhancement Act.
I am pro-life. I believe human life begins at conception. It is at
this moment that th organism is complete--yes, immature--but complete.
An embryo is nascent human life. It is genetically distinct. And it is
biologically human. it is living. This position is consistent with my
faith. But, to me, it isn't just a matter of faith. It is a fact of
science.
Our development is a continuous process--gradual and chronological.
We were all once embryos. The embryo is human life at its earliest
stage of development. And accordingly, the human embryo has moral
significance and moral worth. It deserves to be treated with the utmost
dignity and respect.
I also believe that embryonic stem cell research should be encouraged
and supported. But, just as I said in 2001, it should advance in a
manner that affords all human life dignity and respect--the same
dignity and respect we bring to the table as we work with children and
adults to advance the frontiers of medicine and health.
Congress must have the ability to fully exercise its oversight
authority on an ongoing basis. And policymakers, I believe, have a
responsibility to re-examine stem cell research policy in the future
and, if necessary, make adjustments.
This is essential, in no small part, because of promising research
not even imagined four years ago. Exciting techniques are now emerging
that may make it unnecessary to destroy embryos--even those that will
be discarded anyway--to obtain cells with the same unique
``pluripotential'' properties as embryonic stem cells.
For example, an adult stem cell could be ``reprogrammed'' back to an
earlier embryonic stage. This, in particular, may prove to be the best
way, both scientifically and ethically, to overcome rejection and other
barriers to effective stem cell therapies. To me--and I would hope to
every member of this body--that's research worth supporting. Shouldn't
we want to discover therapies and cures--given a choice--through the
most ethical and moral means?
So let me make it crystal clear: I strongly support newer,
alternative means of deriving, creating, and isolating pluripotent stem
cells--whether they are true embryonic stem cells or stem cells that
have all of the unique properties of embryonic stem cells.
With more Federal support and emphasis, these newer methods, though
still preliminary today, may offer huge scientific and clinical pay-
offs. And just as important, they may bridge moral and ethical
differences among people who now hold very different views on stem cell
research because they totally avoid destruction of any human embryos.
These alternative methods of potentially deriving pluripotent cells
include: (1) extraction from embryos that are no longer living; (2)
non-lethal and nonharmful extraction from embryos; (3) extraction from
artificially created organisms that are not embryos, but embryo-like;
(4) reprogramming adult cells to a pluripotent state through fusion
with embryonic cell lines.
Now, to date, adult stem cell research is the only type of stem cell
research that has resulted in proven treatments for human patients. For
example, the multi-organ and multi-tissue transplant center that I
founded and directed at Vanderbilt University Medical Center performed
scores of life-saving bone marrow transplants every year to treat fatal
cancers with adult stem cells.
And stem cells taken from cord blood have shown great promise in
treating leukemia, myeloproliferative disorders and congenital immune
system disorders. Recently, cord blood cells have shown some ability to
become neural cells, which could lead to treatments for Parkinson's
disease and heart disease.
Thus, we should also strongly support increased funding for adult
stem cell research. I am a cosponsor of a bill that will make it much
easier for patients to receive cord blood cell treatments.
Adult stem cells are powerful. They have effectively treated many
diseases and are theoretically promising for others. But embryonic stem
cells--because they can become almost any human tissue
(``pluripotent'') and renew and replicate themselves infInitely--are
uniquely necessary for potentially treating other diseases.
No doubt, the ethical questions over embryonic stem cell research are
profound.They are challenging. They merit serious debate. And not just
on the Senate floor, but across America--at our dining room tables, in
our community centers, on our town squares.
We simply cannot flinch from the need to talk with each other, again
and again, as biomedical progress unfolds and breakthroughs are made in
the coming years and generations. The promise of the Biomedical Age is
too profound for us to fail.
That is why I believe it is only fair, on an issue of such magnitude,
that senators be given the respect and courtesy of having their ideas
in this arena considered separately and cleanly, instead of in a whirl
of amendments and complicateliamentary maneuvers. I have been working
to bring this about for the last few months. I will continue to do so.
And when we are able to bring this to the floor, we will certainly
have a serious and thoughtful debate in the Senate. There are many
conflicting points of view. And I recognize these differing views more
than ever in my service as majority leader: I have had so many
individual and private conversations with my colleagues that reflect
the diversity and complexity of thought on this issue.
So how do we reconcile these differing views? As individuals, each of
us holds views shaped by factors of intellect, of emotion, of spirit.
If your daughter has diabetes, if your father has Parkinson's, if your
sister has a spinal cord injury, your views will be swayed more
powerfully than you can imagine by the hope that cure will be found in
those magnificent cells, recently discovered, that today originate only
in an embryo.
As a physician, one should give hope--but never false hope.
Policymakers, similarly, should not overpromise and give false hope to
those
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suffering from disease. And we must be careful to always stay within
clear and comprehensive ethical and moral guidelines--the soul of our
civilization and the conscience of our nation demand it.
Cure today may be just a theory, a hope, a dream. But the promise is
powerful enough that I believe this research deserves our increased
energy and focus. Embryonic stem cell research must be supported. It is
time for a modified policy--the right policy for this moment in time.
The PRESIDING OFFICER (Mr. Isakson). The Democratic leader.
Mr. REID. Mr. President, before the distinguished majority leader
leaves the floor, I want to, through the Chair, express to him my
appreciation for the courageous statement he made. It was a moral
decision made by the majority leader of the Senate. His decision will
bring hope to millions of Americans who face these terrible diseases,
and it has even more meaning as a result of the medical background the
Senator from Tennessee has.
I know there is still a long way to go legislatively, but a large
step has been taken by the majority leader today to give hope to the
people of Nevada who suffer from these diseases, the people from
Georgia, Pennsylvania, Tennessee, and all over America. I admire the
majority leader for doing this.
The PRESIDING OFFICER. The Senator from Pennsylvania.
Mr. SPECTER. Mr. President, I congratulate my distinguished
colleague, Senator Frist. I believe the speech which he has made on the
Senate floor is the most important speech made this year and perhaps
the most important speech made for many years because this issue of
embryonic stem cell research is the difference between life and death.
When Senator Frist says what he has stated this morning, it has an
enormous impact as to science because of his unique position and
respected position as a scientist, as a doctor, as a medical
researcher, but enormous impact on Government. I use the word
``government'' instead of ``politics'' because this has an impact on
Government when the majority leader is taking the position which he has
taken. I believe it is especially weighty because of the
thoughtfulness, the deliberation, and the time he has utilized bringing
all of his abilities to bear--his considerable abilities to bear. The
thoughtfulness and deliberation emphasizes the importance of what he
has said.
On a personal note, I have had an opportunity to talk with Senator
Frist about it many times over the course of the past 4 years. I know
how he has wrestled with this issue and how conscientious he is in his
judgment.
One final comment, and that is, Dr. Frist, Senator Frist, Majority
Leader Frist's comments will reverberate far and wide, around the
world. This is a speech which will be heard around the world, including
at the White House. I have had the opportunity to talk with the
President on this issue on a number of occasions. He was in
Pennsylvania 44 times last year, and I had a good opportunity to talk
with him in the car and on the plane. The President made a very
important decision on August 9 of 2001 on liberating some 63 stem cell
lines. There is some discussion as to how many there were. Sixty-three
was the initial line. I know the President will listen to what Senator
Frist has to say. I am not saying he is going to agree with it. But
what Senator Frist has had to say is weighty and I think may bring us
all together on this issue. So I congratulate my distinguished leader.
The PRESIDING OFFICER. The Senator from Kansas.
Mr. BROWNBACK. Mr. President, I, too, wish to recognize the comments
made by the majority leader this morning and to thank him for his call
for a ban on human cloning, which was one of the principles that he
outlined when he spoke this morning. I am interested in bringing this
important topic to the Senate floor for debate.
I would note a couple of points about the different issues we face
when we consider the many new aspects of evolving science. Yesterday
morning's Washington Post found pluripotent adult stem cells being able
to make eggs. Also, the June edition of the Science journal talks about
the antibodies and the alleged problems with embryonic stem cell lines
that are currently being developed. This article states that the
concern with the lines being built on mouse feeder cells is overblown,
and that those concerns are overstated. In addition, I think more of
these lines may end up being available.
I note for my colleagues and the Majority Leader, whom I regard very
highly--he is a brilliant individual and works very hard--that he
articulated 10 principles regarding ethics in research and medical
treatment, and I appreciate them. I was there 4 years ago when the
Majority Leader articulated the 10 principles--this is before he was
Majority Leader--and he has stuck by them today.
However, there is a basic principle involved that is here, and that
is whether or not a young, living human embryo is a life or a piece of
property. And how is it going to be treated? I think we have to deal
with the precursor principles before we can go ahead with unrestricted
research on this issue. Even as carefully as such research may be
drawn, one has to make this determination: Is it life?
Is it person or property? It is one or another. If it is person,
respect it as a person. If it is property, it can be done with as its
master chooses. That is the principle we have to dig into first. I hope
we can get into that in the upcoming debate we will conduct on the
entire range of these issues, hopefully on the entire range of human
cloning and adult stem cell research--adult stem cell research, where
we have 65 human treatments currently taking place.
I appreciate the comments of my colleagues. I do differ on the need
to expand embryonic stem cell research.
I ask unanimous consent to print in the Record the three items that I
referenced.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Benefits of Stem Cells to Human Patients--Adult Stem Cells v. Embryonic
Stem Cells (Published Treatments in Human Patients)
ADULT STEM CELLS: 65--ESCR:0
Cancers
1. Brain Cancer
2. Retinoblastoma
3. Ovarian Cancer
4. Skin Cancer: Merkel Cell Carcinoma
5. Testicular Cancer
6. Tumors abdominal organs Lymphoma
7. Non-Hodgkin's lymphoma
8. Hodgkin's Lymphoma
9. Acute Lymphoblastic Leukemia
10. Acute Myelogenous Leukemia
11. Chronic Myelogenous Leukemia
12. Juvenile Myelomonocytic Leukemia
13. Cancer of the lymph nodes: Angioimmunoblastic
Lymphadenopathy
14. Multiple Myeloma
15. Myelodysplasia
16. Breast Cancer
17. Neuroblastoma
18. Renal Cell Carcinoma
19. Various Solid Tumors
20. Soft Tissue Sarcoma
21. Waldenstrom's macroglobulinemia
22. Hemophagocytic lymphohistiocytosis
23. POEMS syndrome
Auto-Immune Diseases
24. Multiple Sclerosis
25. Crohn's Disease
26. Scleromyxedema
27. Scleroderma
28. Rheumatoid Arthritis
29. Juvenile Arthritis
30. Systemic Lupus
31. Polychondritis
32. Sjogren's Syndrome
33. Behcet's Disease.
34. Myasthenia
35. Autoimmune Cytopenia
36. Systemic vasculitis
37. Alopecia universalis
Cardiovascular
38. Heart damage
Ocular
39. Corneal regeneration
Immunodeficiencies
40. X-Linked hyper immunoglobuline-M Syndrome
41. Severe Combined Immunodeficiency Syndrome
42. X-linked Iymphoproliferative syndrome
Neural Degenerative Diseases/Injuries
43. Parkinson's disease
44. Spinal cord injury
45. Stroke damage
Anemias/Blood Conditions
46. Sickle cell anemia
47. Sideroblastic anemia
48. Aplastic Anemia
49. Amegakaryocytic Thrombocytopenia
50. Chronic Epstein-Barr Infection
51. Fanconi's Anemia
52. Diamond Blackfan Anemia
53. Thalassemia Major
54. Red cell aplasia
55. Primary Amyloidosis
Wounds/Injuries
56. Limb gangrene
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57. Surface wound healing
58. Jawbone replacement
59. Skull bone repair
Other Metabolic Disorders
60. Osteogenesis imperfecta
61. Sandhoff disease
62. Hurler's syndrome
63. Krabbe Leukodystrophy
64. Osteopetrosis
65. Cerebral X-linked adrenoleukodystrophy
____
[From Science Magazine, June 10, 2005]
Ready or Not? Human ES Cells Head Toward the Clinic
Shortly before Congressman James Langevin cast his vote
last month to relax federal rules on funding of stem cell
research, the Rhode Island Democrat told his colleagues, ``I
believe one day I will walk again.'' Langevin, who has been
paralyzed since a gun accident at age 16, pleaded with his
colleagues to vote with him. ``Stem cell research gives us
hope and a reason to believe. . . . We have a historic
opportunity to make a difference for millions of Americans.''
With impassioned pleas like this, high-stakes battles in
Congress, and billions of private and state dollars pouring
into research on human embryonic stem (hES) cells, it often
seems their therapeutic applications must be just around the
corner. But a careful parsing of the claims from even the
strongest advocates reveals the caveat ``someday.''
How soon that someday might arrive is far from clear.
Scientists are nearly unanimous that the study of hES cells
will illuminate human development and disease. But whether
the cells will actually be used to cure patients like
Langevin is less certain. Cell therapies are more complicated
than drugs, and hES cells, which have the potential to become
any cell type in the body, carry special risks.
``The most sobering thing about [hES] cells is their
power,'' says neuroscientist Clive Svendsen of the University
of Wisconsin, Madison, who works with both fetal and
embryonic stem cells. The extreme flexibility and capacity
for growth characteristic of ES cells makes them ideal for
producing large quantities of therapeutic cells to treat,
say, diabetes or spinal cord injuries. But these same traits
also increase the risk that renegade cells could, as they
have in animal studies, cause unwanted side effects,
ending up in the wrong place or even sparking cancerous
growth. ``You have to learn to control that power in the
dish'' before thinking about putting the cells into
patients, says Svendsen.
For that reason, most groups say they are at least five or,
more likely, 10 years away from clinical trials. But one
company is challenging that timeline. Geron in Menlo Park,
California, says its animal studies suggest that stem cell
therapy can be safe and might be effective for a select group
of patients. The company hopes to start clinical trials of
hES cells to treat spinal cord injuries as early as summer
2006. Already, the company is in discussions with the Food
and Drug Administration (FDA), which is attempting to set
safety standards for the field. Potential treatments with
human ES cells face the same difficulties as all cell
therapies, notes Malcolm Moos of FDA's division of cellular
and gene therapies: There are few standardized techniques to
measure the purity or potency of a cell population that would
be delivered to a patient.
Most stem cell researchers view Geron's plans with hefty
skepticism and caution that a premature rush to patients
could seriously damage the already-controversial field. And
it is far from clear whether FDA will allow the trial to
proceed. But Geron, which funded the researchers who isolated
the first hES cells in 1998, has several reasons to push
ahead; the company holds a number of patents and exclusive
licenses that give it more freedom--and more incentive--to
develop possible products from hES cells. And whatever the
outcome, scientists agree, Geron's ambitious plans will offer
a test case of the hurdles scientists will have to overcome
to prove that hES therapies are both safe and effective.
Even the skeptics say Geron chose a plausible target for
the first trial, as spinal cord injuries may be significantly
easier to tackle than diseases such as diabetes or
Parkinson's. The trials would be based on work led by Hans
Keirstead, a neuroscientist at the University of California,
Irvine, who proved a persuasive spokesperson for the field
during the campaign for California's Proposition 71, which
provides $3 bil1ion in funding for hES cell research.
During last fall's campaign, Keirstead described his then-
unpublished work, showing videos of rats with spinal cord
injuries that had regained some mobility after injections of
cells derived from hES cells. ``I am extremely
enthusiastic,'' Keirstead says. ``I am past the point of
hope. In my mind the question is when. What we are seeing in
these animal models is tremendous.''
Keirstead and his colleagues, with funding and technical
support from Geron, have developed a protocol that encourages
hES cells to differentiate into cells called oligodendrocyte
precursors. These cells can form oligodendrocytes, the cells
that, among other functions, produce the protective myelin
sheath that allows neurons to send signals along their axons.
This sheath is often lost during spinal cord injuries.
In a paper last month in the Journal of Neuroscience,
Keirstead's team reported that these precursors, when
injected into the spinal cord, could help improve recovery of
rats that had suffered spinal cord injury. The cells aren't
replacing injured neurons, Keirstead says, but are
encouraging the natural healing process, presumably by
restoring some of the myelination. Earlier studies in mice
(Science, 30 July 1999, p. 754) showed that injecting mouse
cells destined to form oligodendrocytes into injured or
diseased animals could restore some myelination; Keirstead's
team is the first to show that human ES cells can have
similar effects.
For newly injured rats, the results are promising. In
animals that received oligodendrocyte precursors 7 days after
their injury, the cells survived and apparently helped repair
the spinal cord's myelin. Within 2 weeks, treated rats scored
significantly better on standardized movement tests than
control animals, which had received human fibro-blasts or a
cell-free injection.
But when the researchers injected cells 10 months after the
injury, they saw no effect-sobering news for people
like Langevin suffering from old injuries. The cells
survived but were apparently unable to repair the long-
term damage. For that reason, Keirstead says, Geron's
proposed clinical trial would target newly injured
patients.
The phase I trial, if it goes forward, will probably
include only a handful of patients and, most importantly,
Keirstead emphasizes, will not cure anyone. Its primary goal
is to show that the treatment can be safe. ``The public and
scientists must realize that these are the first attempts,''
Keirstead says. ``No one is expecting them to cure. We are
expecting them to treat, but we have no idea what the level
of response is going to be.''
Proving safety is a tall enough order. In numerous animal
studies, ES cells from mice and humans have proved difficult
to control, differentiating into the wrong kind of cell, for
instance, or migrating away from the injection site.
In its spinal cord trial, Geron plans to inject ES-derived
cells that can form just a single cell type, an approach that
may circumvent some of these problems. For a full recovery,
patients are likely to need new neurons as well as other
support cells called astrocytes, but using precursors that
differentiate into all three types of nerve cells can be
problematic. In several rodent studies, partially
differentiated mouse ES cells injected into the spinal cord
have formed neurons, astrocytes, and oligodendrocytes and
have helped animals recover from spinal cord injuries. But
more recently, neural stem cells derived from adult animals
which also differentiate into the three cell types-have
caused problems. As Christoph Hofstetter of the Karolinska
Institute in Stockholm, Sweden, and his colleagues reported
in Nature Neuroscience in March, neural stem cell treatments
led to some recovery in rats' paralyzed hind legs, but the
animals also developed a chronic pain sensitivity in their
forelegs, which had been unaffected by the injury. In other
experiments, preventing the formation of astrocytes seemed to
eliminate the side effect, highlighting the importance of
proper differentiation, Svendsen says.
Perhaps the biggest worry is that hES therapies will spur
tumor formation. One of the defining characteristics of ES
cells is that they form disorganized tumors, called
teratomas, when injected in undifferentiated form under the
skin of immune-compromised mice. ``The ES cell is basically
a tumor-forming cell,'' says neuroscientist Anders
Bjorklund of Lund University in Sweden. ``This aspect has
to be dealt with seriously before the cells are applied in
the clinic.'' Even a benign tumor in the central nervous
system would be serious, says Svendsen: ``Any sort of
growth in the spinal cord is not good news.''
But Keirstead believes he has solved those problems. The
key, he says, is a differentiation procedure that he claims
produces cell populations in which 97% of cells express genes
typical of oligodendrocyte precursors. ``Teratomas are a real
possibility if you put in naive stem cells,'' he
acknowledges. ``But that is the science of yesteryear. No one
is even considering putting in any naive ES cells.''
Keirstead and his colleagues say in their paper that they
found no evidence that their specialized cells formed
astrocytes or neurons after injection. The team is also
checking whether any of the injected cells leave the spinal
cord. So far, Keirstead says, they seem to stay close to the
site of injection.
Keirstead's paper is promising, Svendsen says, but he's not
convinced the work is ready for patients. ``It didn't go into
the detail you'd like to see before a clinical trial,'' he
says. The catch is that it's hard to be sure that a
population of several million cells is free of any
undifferentiated stragglers. To evaluate the risk of tumors,
Keirstead and his colleagues are testing the differentiated
cells in nude mice: animals bred to lack an immune system. If
the animals live for a year without signs of teratomas, then
Keirstead says he will feel confident that the cells are safe
to try in humans.
Several teams are making headway addressing another
problem: possible animal contamination. To date, almost all
human ES cell lines have been exposed to animal products.
Cultured cells are often kept alive with fetal calf serum,
for instance, and most hES cell lines have been grown on
layers of mouse cells called feeder cells, which provide the
key proteins that prevent ES cells from differentiating.
[[Page S9328]]
These techniques have sparked worries that hES cell
therapies could introduce exotic animal viruses into
patients. In response, several teams, including Geron,
have recently developed ways to grow new cell lines either
on human feeder layers or without feeder cells at all.
But the older cell lines have the advantage of being better
characterized, says Geron CEO Thomas Okarma. That's why the
company plans to use one of the original lines derived by
James Thomson of the University of Wisconsin, Madison, in its
first clinical trial. To reduce the risk of contamination,
the company has been growing these cells for more than a year
without any feeder cells. That may suffice for FDA, which has
said that past exposure to animal cells does not disqualify
ES cell lines from clinical use as long as certain safety
standards are met.
Okarma says Geron can demonstrate that its cells are
uncontaminated. His claim is bolstered by a paper by another
group published last week in Stem Cells. Joseph Itskovitz-
Eldor of Technion-Israel Institute of Technology in Haifa and
his colleagues tested five hES cell lines and several
cultures of mouse feeder cells for signs of murine
retroviruses, which lurk in the genome of all mouse cells.
Although the team identified receptors for the so-called
mouse leukemia viruses, they found no evidence that the virus
had infected any of the human cells, even after growing on
mouse feeders for years. Animal products still may pose a
risk, says Itskovitz-Eldor. But the new work shows that ``the
cells can be tested, and we believe it will be possible to
use them clinically.''
More recently, researchers identified another potential
downside to using mouse feeder cells. In February, Fred Gage
and his colleagues at the Salk Institute for Biological
Studies in La Jolla, California, reported that hES cells
grown with mouse feeders expressed a foreign sugar molecule
on their cell surface. Because humans carry antibodies to the
molecule, the researchers suggested that it might tag the
cells for destruction by the human immune system. If so, then
any therapy created with existing cell lines was unlikely to
succeed. But Keirstead, Okarma, and others now say that those
concerns, widely reported, may have been overstated. Gage and
his noted that the sugar gradually disappears once cells are
removed from the feeder layers. Keirstead says that once
cells are removed from mouse feeder layers for several
months, the sugar disappears. Okarma adds that cells in
Geron's feeder-free cultures have no sign of the foreign
molecule.
Finally, some scientists worry that ES cells might acquire
harmful new mutations in culture, a common phenomenon with
almost all cultured cells. Although ES cells ``are probably
100 times more stable than adult stem cells in culture,
they're not perfect,'' cautions Mahendra Rao of the National
Institute on Aging in Baltimore, Maryland. Such mutations
would be particularly hard to detect ahead of time.
FDA, meanwhile, is trying to set safety standards for this
burgeoning field. The agency announced in 2000 that cell
therapies involving stem cells from embryos or adults would
be regulated as drugs, not as surgical techniques. That means
that researchers will have to meet certain standards of
purity and potency. For most drugs, those standards are
straightforward to set and easy to measure. Cellular products
are much more complicated, * * *
____
Still Waiting Their Turn
Even enthusiasts agree that Geron's goal--to begin testing
a human embryonic stem (hES) cell therapy in patients with
spinal cord injury within a year--is a long shot. Prospects
are more distant for using stem cells to treat other
diseases, such as diabetes, Parkinson's disease, amyotrophic
lateral scleroris (ALS), and multiple sclerosis (MS). None is
likely to reach the clinic for at least 5 to 10 years, most
scientists in the field agree. And that's assuming abundant
funding and faster-than-expected scientific progress.
Some of the strongest advocates for hES cell research are
those hoping to find a cure for type 1 diabetes. The driving
force behind California's Proposition 71, Robert Klein, says,
for example, that his primary motivation is to find a cure
for his diabetic son. Diabetes kills the pancreas's B cells,
which regulate the amount of insulin in the blood. Patients
have to take frequent insulin injections and face many
complications, including kidney failure and blindness.
Replacing the missing cells could cure the disease. Initial
trials using B-cell transplant from cadavers have shown
promise, but side effects and the transplants' limited life
span has dampened enthusiasm (Science, 1 October 2004, p.
34). And even if the therapy worked perfectly, each
transplant requires cells from multiple cadavers. So
researchers are looking for renewable sources of cells that
could treat the millions of patients who might benefit.
In theory, hES cells fit the bill nicely. In practice,
however, although several groups have managed to coax mouse
ES cells to differentiate into cells that make insulin, no
one has yet managed to derive bona fide B cells from either
mouse or human ES cells. One reason may be that unlike nerve
cells or heart muscle cells, pancreatic cells are some of the
last to develop during pregnancy. In mice, the cells appear
on day 15 or 16, just a day or two before birth, and in
humans, they appear in the 5th or 6th month. ``If the road is
longer, the possibility of getting lost is much higher,''
explains Bernat Soria of Miguel Hernandez University of
Alicante, Spain, who has tried to produce B-like cells from
both mouse and human ES cells. Fortunately , says Soria, the
cells may not have to be perfect; several types of insulin-
producing cells have helped alleviate diabetes symptoms in
mice.
But there is no leeway when it comes to safety. Diabetes is
a chronic but not inevitably deadly disease, so any cell
therapy must be safer and more effective than insulin shots.
``We don't have a cure, but we have a treatment,'' Soria
says. ``Despite the strong pressure we have from patients and
families, the need for cell therapy is not as strong.
Scientists have already attempted to use cell therapies to
treat Parkinson's disease, which attacks neurons in the brain
that produce the neurotransmitter dopamine, leaving patients
increasingly unable to move. In a handful or clinical trials
in the last decade, physicians implanted dopamine-producing
cells from fetal tissue--with decidely mixed results. Whereas
some patients showed significant improvement, others show
little or none. And some developed serious side effects
including uncontrollable jerky movements. Scientists
aren't yet sure what went wrong, although some suspect
that patients may have received either too many or too few
fetal cells, which are difficult to characterize in the
lab.
Dopamine-producing neurons derived from ES cells could
provide an unlimited and well-characterized source of cells.
And a trial in monkeys from a team at Kyoto University found
that dopamine-producing neurons grown from monkey ES cells
could improve animals' symptoms. But before ES-derived cells
are tested in Parkinson's patients, scientists need to
understand more about how the transplanted cells are behaving
in the brain, says neuroscientist Anders Bjorklund of Lund
University in Sweden. ``The knowledge is just not good enough
yet to justify any clinical trials'' with hES cells, he says.
Patients and doctors facing the nightmare of ALS may be
willing to accept higher risks associated with early hES cell
treatments. There is no effective treatment for this
invariably fatal disease that kills motor neurons, and
patients usually die within 5 years of a diagnosis. But ``ALS
is an order of magnitude harder than other diseases'' to
treat with cell therapy, says motor disease specialist
Douglas Kerr of Johns Hopkins University in Baltimore,
Maryland. Doctors still aren't sure what causes the disease,
and even if scientists could coax stem cells to replace the
lost motor neurons--``a pretty tall order,'' Kerr says--any
new neurons could be subject to the same deadly assault. More
promising, he says, would be a cell or a mixture of cells
that might somehow help slow the damage, but no one is sure
what that might look like.
Treating MS has similar challenges, says Hans Keirstead of
the University of California, Irvine, who is working with
Geron on its possible spinal cord injury trial. ``We're much
farther away from treating MS with stem cells,'' he says.
Like spinal cord injuries, the disease attacks the myelin
sheath around nerve cells, and injected oligo-dendrocyte
precursors have shown positive effects in animal models. But
the human situation is more complicated, Keirstead says.
Nerves damaged by MS are already surrounded by
oligodendrocyte precursors, but something stops the cells
from working. Indeed, Keirstead, who is relentlessly
optimistic about the prospects of helping spinal cord injury
patients, sounds much more sober about the prospects for
other patients. ``When I look at the work with Parkinson's,
MS, and stroke, I think spinal cord injuries are very
amenable to these strategies. The rest of the central nervous
system is not.''
____
[From the Washington Post, July 28, 2005]
Scientists Claim To Find Cells That Restore Egg Production
(By Rob Stein)
A team of Harvard scientists is claiming the discovery of a
reservoir of cells that appear capable of replenishing the
ovaries of sterilized mice, possibly providing new ways to
help infertile women have babies.
While cautioning that more research is needed to confirm
that similar cells exist in women and that they can safely
restore fertility, the researchers said the findings could
revolutionize the understanding of female reproduction and
the power to manipulate it.
``This may launch a new era in how to think about female
infertility and menopause,'' said Jonathan L. Tilly, a
reproductive biologist at Harvard Medical School and
Massachusetts General Hospital in Boston who led the
research. It is being published in tomorrow's issue of the
journal Cell.
Other researchers agreed that the findings could have
profound implications, but several expressed caution and
skepticism, saying many key questions remain about whether
the researchers have proved their claims.
``This is really exciting and a revolutionary idea. The
implications are potentially huge,'' said Lawrence Nelson of
the National Institute of Child Health and Human Development.
``But before this could have any type of application to
humans, a whole lot of work has to be done. We have to be
careful not to get ahead of ourselves.''
But Tilly said he was confident of his findings, which
could, for example, enable women to bank egg-producing cells
when they are young in case they have health
[[Page S9329]]
problems that leave them infertile or they get too old.
``In theory, these cells could provide an insurance policy.
We could harvest them and store them away for 20 years. Then
you put them back in, and they are going to do exactly what
they are supposed to--find the ovaries and generate new
eggs'' to restore fertility, Tilly said.
The discovery could also lead to ways to prevent, delay or
reverse menopause, perhaps by stimulating dormant cells in
the bone marrow or ``tweaking'' the ovaries to accept them,
Tilly said. It may also be possible to transplant them from
one woman to another, he said.
In addition, because the cells appear to be a particularly
versatile type of adult stem cell, they could provide an
alternative to those obtained from embryos, avoiding the
political and ethical debates raging around the use of those
cells.
``The implications are mind-boggling, really,'' Tilly said.
The research is a follow-up to results the team reported in
March 2004, when it claimed it had shown that mice can
produce eggs throughout their lives. For decades, scientific
dogma has been that female mammals such as mice and humans
are born with a finite number of eggs. To alleviate doubts
about their original claim, the researchers conducted another
round of experiments, which they said confirm the findings
and explain how it might work.
First, the scientists sterilized female mice with a cancer
chemotherapy drug that destroyed eggs in the ovaries but
spared any egg-producing cells elsewhere. They tested the
animals' ovaries 12 to 24 hours later and found signs their
egg supply was rapidly regenerating. Two months later, the
animals' ovaries looked normal, and they remained that way
for life.
After tests indicated the source of the cells may lie in
the animals' bone marrow, the researchers infused marrow from
healthy mice into those that were either genetically
engineered to be infertile or had been made infertile with
chemotherapy. Two months later, the recipients' ovaries
looked normal, whereas those that had not received the
transplants remained barren, the researchers reported. Blood
transfusions produced similar results, they said.
The researchers then infused blood into infertile mice from
animals that had been genetically engineered so that their
reproductive stem cells glowed fluorescent green. Within two
days, green egg cells appeared in the recipients' ovaries,
which the researchers said indicated the cells had traveled
through the blood to the ovaries.
Finally, the researchers screened human bone marrow and
blood from healthy women and found that both tested positive
for biological markers indicating the presence of immature
reproductive cells.
``Mice and humans appear to be the same--they appear to
have a set of genes in bone marrow consistent with . . .
cells that can make themselves a new egg,'' Tilly said.
The findings could help explain previously mysterious cases
of women sterilized by cancer treatment who spontaneously
became pregnant after receiving bone marrow transplants,
Tilly said. This may happen only rarely because some, but not
all, techniques used to process bone marrow before
transplantation may destroy the cells in some cases, he
speculated.
The research triggered a mixture of excitement, caution and
deep skepticism.
``It's quite amazing,'' said Hans Schoeler of the Max
Planck Institute in Germany. ``The idea that cells from bone
marrow may be a reservoir for egg cells would be quite
astonishing.''
But Schoeler and other researchers cautioned that many
crucial questions remained. Several researchers had doubts
about some of the techniques the researchers used. Others
were puzzled by the speed with which the ovaries appeared to
be repopulated with eggs. Many pointed out that the
researchers had failed to show the eggs were viable, the mice
were ovulating or that they could give birth to healthy
offspring.
``I'm very skeptical,'' said David F. Albertini of the
University of Kansas Medical Center in Kansas City, Kan.
``There are a lot of holes in the research.''
Tilly attributed the skepticism to the radical nature of
the findings and said he already had work underway to address
the concerns, including breeding studies aimed at producing
healthy offspring.
``We hope we will have the answers very soon,'' Tilly said.
The PRESIDING OFFICER. The Senator from Tennessee.
Mr. ALEXANDER. I ask unanimous consent to speak as if in morning
business for 4 minutes.
Mr. President, this morning, the majority leader made some comments
regarding stem cell research. I appreciate his comments. It was a
statement of conscience. I think for each of us in the Senate this
issue comes down to a statement of conscience. I believe we need to
take additional steps in support of stem cell research and control it
in an ethical way because it has the promise of saving lives. I
therefore support the House-passed legislation that Senator Specter and
Senator Hatch have introduced. I support the legislation that our
Health, Education, Labor, and Pensions Committee has reported to the
Senate for Federal support for cord blood research. I am looking
forward to seeing more from Senator Coleman regarding his work to
develop an alternative way of supporting Federal research for stem
cells which already exist, but not in the future. In other words, I am
looking for ways to support this important research because it has the
promise of saving lives.
I am pro-life, Mr. President. I am opposed to human cloning. I will
vote to criminalize human cloning. But I support this legislation that
is offered by Senator Hatch and Senator Specter. President Bush has
already said that Federal funds may be used in some cases for research
on some stem cell lines derived from fertilized eggs. With the help of
fertility clinics, some prospective parents use fertilized eggs to help
them have children. Those excess eggs that these parents do not use are
often thrown away. I support using some of those fertilized eggs that
would otherwise be thrown away under carefully controlled conditions
with the consent of the donors for potentially lifesaving research that
may help cure juvenile diabetes, Parkinson's disease, spinal injuries,
and other debilitating diseases.
I thank the Chair.
The PRESIDING OFFICER. The Senator from Illinois.
Mr. DURBIN. Mr. President, I thank the majority leader for his
statement. I think it is extremely important that he has joined a
bipartisan effort in the Senate to make progress on a critically
important issue.
Senator Frist and I have our differences politically, but I respect
and admire him very much, particularly in his humanitarian efforts as a
doctor. All of us in the Senate know while we may be back home in our
States, he is off in some of the poorest places in the world using his
medical skill to save lives. It says a lot about him. It says a lot
about his heart, as does his statement this morning.
The fact he would come out and suggest that we need to move forward
in stem cell research is going to give new hope to people who
absolutely count on medical research for their future and for the life
and well-being of members of their families.
I have had roundtable discussions in my State. I have invited people
who are suffering from diabetes, Parkinson's, Lou Gehrig's disease, and
from spinal cord injuries. They have all come forward to tell me how
critically important stem cell research could be to making their lives
whole and better.
Senator Frist's decision today will move us toward a goal, a very
important goal of establishing good lines for pursuing this research.
The Castle-Degette bill, which comes from the House of Representatives,
provides a conscience clause. It says neither the sperm nor egg donor
can be asked to give up anything they put into the in vitro process
without their consent. There must be a conscience clause included in
this process. I agree with that.
We also must establish that we are opposed to human cloning, which I
am, and I don't know of any Senator who disagrees. Human cloning is
wrong, and we must draw strict ethical guidelines to make sure we do
not cross that line.
Also, we never want to see the commercialization of this process.
This is about scientific research. It is not about who is going to make
a profit, and the Castle-Degette bill is very explicit in that regard.
My colleague from Kansas raises an important point. It is one he and
I can debate and it can be debated for centuries about when life
begins. I am not sure we will ever come to the same conclusion, but it
is important we talk about it.
The thing that troubles me about this debate is that those who oppose
stem cell research apparently are not prepared to criminalize in vitro
fertilization. They are prepared to allow the process to move forward
knowing full well in the ordinary course of events in the laboratory,
there will be stem cells that cannot be used to impregnate the woman
who is seeking to have a baby.
Mr. BROWNBACK. Will my colleague yield for a comment on that point?
Mr. DURBIN. When I finish my remarks, I will be happy to do so.
The point I am making is this: I have a friend, a woman I have known
since
[[Page S9330]]
she was a young girl. She is married. She and her husband were unable
to bring a child into this world. They went to the doctor and said:
Could in vitro be the answer? The doctor said: We can try.
They spent $40,000 trying unsuccessfully. Heartbroken, they went home
and waited and saved up enough money and borrowed enough money to try
again, and they were successful. They have a beautiful baby whom they
love to pieces.
They went to those extraordinary lengths because of their love for
one another and their desire to bring life into this world together. I
cannot believe there is anything immoral about that motive or that
effort by this couple and hundreds or thousands of other couples across
America.
The Senator from Kansas knows and I know that in the course of in
vitro fertilization for these good reasons, there will be stem cells
that are not going to be used to impregnate the woman who is seeking to
have the baby. Some of them are frozen for future use, many are
currently discarded. If the argument from the Senator from Kansas is
that they are life and, therefore, cannot be used for research, then I
can't understand why the Senator is not calling for the criminalization
of in vitro fertilization which necessarily leads to excess stem cells.
Mr. BROWNBACK. Mr. President, I will be happy to respond.
Mr. DURBIN. Without my yielding the floor.
Mr. BROWNBACK. If I could, Mr. President, and I thank my colleague
from Illinois for engaging in the debate because I think that it is a
debate that we have needed for a long time.
It appears we have agreement that life does begin at conception.
Senator Kerry campaigned on that running for President.
I presume my colleague from Illinois agrees similarly. Others have
argued, yes, an embryo is alive but it is not yet a life.
To say that a young human embryo is alive, but it's not yet a life,
seems to be a bit of a legal fiction--if we are going that route. A
young human embryo is biologically and genetically distinct. It is a
separate entity. It is alive. It should be treated as either a person
or a piece of property.
My colleague may know that in some countries in Europe on this IVF
procedure, they are very careful about the number of eggs that can be
harvested and fertilized before they are implanted. I think that would
be a good process for us to pursue and to look at so that it is not a
huge multiple set of lines but a much narrower group that are created--
so that they are treated with the dignity and respect that life should
merit and that life should have.
I think my colleague from Tennessee was saying this since he
obviously referred to the entity in question as a nascent life. So let
us look at that and let us start going at those areas. Would you try to
lead to criminalization, and I recognize that may be a good point in
the debate but that is not anywhere near where we are today. Let us
begin with the young humans with respect and dignity that life merits.
Mr. DURBIN. If I could reclaim my time and respond, and then I would
respond to a question from the Senator from North Dakota. The point I
am making to the Senator from Kansas is--and I think probably Senator
Frist, even as a medical doctor, would say that we struggle to figure
out at what moment this is life. When we are dealing with the sperm and
semen and the ovum, are they live cells? Certainly, they are live
cells. There is life in those cells. If they were not, they would have
no value in this process.
So to say there is life in the cells does not necessarily say we are
dealing with a person. At what point does this become a person? This
has been debated for as long as humans have been on Earth.
The point I am trying to make is I believe we should protect life,
but we better be careful that in protecting life we are not avoiding
our responsibility to protect the living. What Senator Frist is
suggesting--I do not want to put words in his mouth. What I believe is
that stem cell research helps us to protect the living.
I yield to the Senator from North Dakota for a question.
Mr. DORGAN. I looked forward very much to having a debate on stem
cell research in the month of July. It now appears that that will not
be the case. Nonetheless, I compliment the Senator from Tennessee, the
majority leader, on his statement this morning.
I did want to make this point and ask a question of the Senator from
Illinois. Is it not the case that those unused frozen embryos at in
vitro fertilization clinics can become one of a couple of things? First
and foremost, at the moment when they are unused and discarded, they
become hospital waste. Second, and importantly, they can, if used in
stem cell research, be used in the important medical research to
preserve and to save lives.
I say to my colleague from Kansas, I have lost a daughter to heart
disease--many of us have lost loved ones. I will never, ever, on the
floor of this Chamber, be a part of those who wish to shut down
promising medical research, especially when the ability to provide that
research comes from embryos that otherwise would become hospital waste.
My colleague from Illinois asked the pertinent question, and perhaps
when we have this debate some day we will have a greater description of
that, but if in fact that is a human life which is now thrown in the
waste basket as hospital waste, unused embryos that are discarded, if
in fact that is a human life--it is not, by the way--should the
destruction of that as hospital waste not be treated criminally? That
would be the logical extension of some of those who are on the Senate
floor wishing to shut down this promising area of research.
My hope is that we can thoughtfully, with ethical guidelines, proceed
with research that is pro-life, that will save lives, that will give a
lot of Americans greater hope for the future who suffer from dreaded
diseases. I look forward to this debate. I wish very much it had been
in the month of July, but nonetheless we will have this debate. When we
do, I hope we will have a full and open discussion about it and advance
the cause of saving lives in this country and around the world.
Mr. DURBIN. If I could, I will say very briefly in response, I am
disappointed that we did not resolve this issue favorably in the month
of July in the Senate, but I am heartened by the statement made by the
majority leader today. It is my belief that we have set the stage to
return in September and take up this important lifesaving issue, with a
critical bipartisan debate on the Senate floor, for the good of medical
research and to bring hope to a lot of people who watch every move we
make on this issue.
I yield the floor.
The PRESIDING OFFICER. The majority leader is recognized.
Mr. FRIST. Mr. President, first, I appreciate the comments of my
colleagues and the distinguished Senator from Kansas, really all of my
colleagues who have spoken. This is a very important issue that we will
come back and address, and I appreciate their comments.
____________________