[Congressional Record (Bound Edition), Volume 147 (2001), Part 10]
[Senate]
[Pages 13582-13588]
[From the U.S. Government Publishing Office, www.gpo.gov]



                           STEM CELL RESEARCH

  Mr. FRIST. Mr. President, I rise to speak to a topic that is very 
much on the minds of the American people as well as policymakers in 
Washington, DC; that is, the issue of embryonic stem cell research. The 
issue of embryonic stem cell research is one that has captured the 
imagination of people all over the world in the last 2 to 3 years. It 
wasn't that long ago that the idea of taking cells very early in life 
and having their potential captured and set in different directions to 
help treat disease--to help make diagnoses--was really just a 
pipedream. Literally, it was 2 or 3 years ago.
  Now, because of the advances in science, the advances in technology 
and the tremendous research that is being conducted in this country 
and, indeed, around the world, a whole new frontier has opened--the 
frontier of what is called stem cell research. I will mention a little 
bit about what that is, but what captures people's minds so much is the 
promising aspect of this research. What has inspired such interest in 
this is the fact that people with numerous diseases, for really the 
first time in their lives, can look ahead and say there is the 
potential for a cell at its earliest level to be channeled in certain 
directions to make the care of that disease easier, and possibly even 
cured.
  The same hope--I hear it daily--is expressed by people with diabetes, 
Alzheimer's disease, or Parkinson's disease, and for spinal cord 
injuries. Indeed, this stem cell research--both adult stem cells and 
embryonic stem cells--has opened up a new frontier that is full of 
potential, full of hope, and full of promises.
  The issue is being addressed by the leaders of our country. It is 
being addressed in amendments on the floor of the Senate. It is being 
addressed by groups considering the ethics among the think tanks. It is 
being considered by the administration as we speak.
  I would like to make four points.
  No. 1, in any of these arenas where we are talking about life--and 
indeed I believe upon fertilization--there is a continuum from a sperm 
and an egg, to a blastocyst, to a fetus, to a child, to an adolescent, 
to an adult. That continuum is indeed life.
  As policymakers, we will be injecting our own feelings and our own 
beliefs into this debate as we go forward. Therefore, I wish to make it 
clear to my colleagues that from my perspective I do value life and 
give moral significance to the embryo and to the blastocyst and to that 
full continuum.
  I, indeed, am pro-life. I oppose abortion. My voting record on the 
floor of this body is consistent with that. Those beliefs are based on 
the very strongly held spiritual beliefs that I have. They are based on 
my medical understanding, having spent 20 years in the field of 
medicine, and in science--that medical understanding of this process of 
life and of living tissues. I do give moral significance to the embryo, 
as I mentioned earlier.
  Second, I am a transplant surgeon. I had the opportunity to serve on 
committees that looked at the ethical considerations surrounding the 
use of tissues and the transplantation of those tissues. I have served 
on committees sponsored by the United Network For Organ Sharing--the 
registry that oversees transplantation in this country. I have served 
on the board of local organizations and tissue procurement agencies. I 
have served on the ethics committees within hospitals. I have had the 
real privilege of writing scores of peer-reviewed papers in the field 
of transplantation and scientific papers in the field of 
transplantation--both basic science and clinical transplantation of 
living tissues. I wrestle on a daily basis with these decisions 
surrounding life and death and health and healing. I have had the 
opportunity to routinely deal with many of these end-of-life tissues.
  I have also been blessed with having had the opportunity and the 
training to transplant tissues myself--to take a beating heart out of 
an individual who has healthy lungs, a healthy heart, healthy kidneys, 
and to take that beating heart from that individual that, yes, does 
terminate the living function of the lungs and the kidneys and the 
other organs, but to take that heart and give it to another on really a 
weekly basis before coming to the Senate, and allowing that individual 
to live in a new life, a better quality of life; an individual who 
without that transfer of tissue otherwise had no hope.
  I mention that, because the ethical construct and ethical and moral 
decisionmaking that we are having to face today in a much earlier point 
on this continuum of life is very similar to what we debated and talked 
about--what our scientists debated and talked about--what our ethicists 
did--what our medical scientists did about 30 years ago in 
transplantation. To whom do you give scarce resources? To whom do you 
not give a heart or a lung because we have this shortage? Which organ 
tissues are suitable for transplantation?
  I have had the privilege--really the blessing--to be able to see the 
rigorous

[[Page 13583]]

consent process we have now established in a very solid fashion 
surrounding the use of tissue taken from one source and given to 
another source. Again, it is not an exact parallel, but it is similar 
from the large ethical construct in transplantation 30 years ago to 
what happens after birth, to the moving of tissues, or cells in this 
particular case, in a period much earlier along the time line, at a 
time 5 to 6 days after a sperm and egg come together.
  I am convinced, based on this personal experience, based on 
professional experience, that we can address this use of living tissue, 
living tissue that otherwise would not be used. It is critically 
important that we understand, and in our moral and ethical framework 
ensure, that this tissue otherwise would not be used. It is similar to 
the fact that when I do a heart transplant, that heart otherwise would 
not be used for anything useful. That individual would likely be buried 
6 days later or 10 days later.
  To use that tissue that has no other use--and that is where this 
informed consent process is important when we are talking about stem 
cell research, to benefit other people, people with diabetes and 
Parkinson's disease and Alzheimer's and spinal cord injuries, who may 
potentially benefit from this new research.
  It was not easy in transplantation 30 years ago, but we did it. And 
through organizations such as the United Network for Organ Sharing, a 
national registry, strong Government oversight, full transparency, full 
public accountability, discourse among not just the scientists--because 
they are going to push for it hard--but discourse on the public square, 
where you get the input of the theologians and the ethicists and the 
philosophers and the medical doctors and the clinicians, and the 
parents, as well as the scientists themselves--the consent process; I 
will come back to it very briefly--but the consent process must be 
comprehensive.
  That is the only way we can avoid the potential abuse, the potential 
for overcommercialization of this process. We have to make sure the 
consent process protects against coercion. We can look back to that 
transplant arena because we addressed it 30 years ago. Again, this is 
much later in the continuum of life, when we are doing heart 
transplants and lung transplants, but we must come back and superimpose 
a comprehensive consent process much earlier in time.
  The third issue is research. As I mentioned, this is new research. It 
is exciting. It gives hope to millions and millions of people. But 
let's not over-sell the potential. This research is new. It is 
uncharted. It is evolving. It is untried and untested. Therefore, we 
cannot predict exactly what is going to come from this research. So 
let's not oversell the research in order to build public support for 
whatever position we take.
  We should not let the potential of this research drive the moral 
considerations themselves. Thus, we must set up a very important, 
strong, transparent, ethical construct in which this decisionmaking can 
be made, and needs to be made, on an ongoing basis. We do not know what 
the next great discovery is going to be 6 months from now. We cannot 
lock into place either the moral considerations or the way we consider 
whether or not it is appropriate to look in a new field of science.
  So the oversight process has to be responsive, has to be ongoing. It 
has to recognize that science moves very quickly. The lack of 
predictability means there is the potential for abuse of the science 
itself. Again, that is why we must consider this issue in this body, 
why politics or policy must be engaged to prevent the potential for 
abuse. Anytime we are talking about the manipulation of life or living 
tissues at this early point, there is the potential for abuse. Thus, I 
conclude that embryonic stem cell research and adult stem cell research 
should be federally funded within a carefully regulated, fully 
transparent, fully accountable framework that ensures the highest level 
of respect for the moral significance of the human embryo, the moral 
significance of the human blastocyst.
  There is this unique interplay of this potentially powerful 
research--uncharted research--this new evolving science with those 
moral considerations of life, of health, of healing. That interplay 
demands this comprehensive, publicly accountable oversight structure I 
propose.
  I very quickly have addressed this issue in a comprehensive way. The 
reason I am in this Chamber and take this opportunity to speak is for 
people to actually see that the issue is a complicated issue but one 
that has to be addressed in a larger framework than just to say: 
Funding, yes or no.
  There are basically 10 points I think we must consider, and I have 
proposed an answer. Again, I don't know the answer, and I struggle, 
like every person, on this particular issue to make sure we have the 
appropriate moral considerations. But I will outline what my 10 points 
are.
  No. 1, we should ban embryo creation for research. The creation of 
human embryos solely for research purposes should be strictly 
prohibited.
  No. 2, we should continue the funding ban on the derivation of 
embryonic stem cells. We need to accomplish this by strengthening and 
codifying the current ban on Federal funding for the derivation of 
embryonic stem cells.
  No. 3, we should ban human cloning. We need to prohibit all human 
cloning to prevent the creation and the exploitation of life for 
research purposes.
  No. 4, we should increase adult stem cell research funding. These 
adult stem cells, stem cells that are removed from an adult, that you 
can back out in such a way that you can capture the potential for using 
them for treatments for various diseases--we should increase this 
funding for research on adult stem cells to ensure the pursuit of all 
promising areas of stem cell research, on both adult stem cells which 
occur much later in life and the embryonic stem cells which are derived 
at the 5- or 6-day-old blastocysts.
  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.
  No. 6, require a rigorous informed consent process to ensure that the 
blastocysts used for stem cell research are only those that would 
otherwise be discarded. We must require a comprehensive informed 
consent process establishing a clear separation between a potential 
donor's primary decision to donate blastocysts for adoption or to 
discard blastocysts and their subsequent option to donate blastocysts 
for research purposes. Such a process is modeled on this well 
established and broadly accepted organ and tissue donation process in 
which I have been so intimately involved over the last 20 years.
  No. 7, limit the number of stem cell lines. I believe we should 
restrict federally funded research using embryonic stem cells derived 
from blastocysts to a limited number of cell lines. This does not mean 
limiting it to research using stem cells that have already been derived 
to date, most of which would reportedly not be eligible even under the 
current NIH guidelines that need much strengthening. In 
transplantation, when I remove a heart from an individual and I give it 
to another individual, that one individual benefits. With stem cells, 
it is very different. From a stem cell line, you derive the cells, and 
that stem cell line can be used for multiple experiments, thousands of 
investigations as we go forward.
  No. 8, establish a strong public research oversight system. I believe 
we should establish an appropriate public oversight mechanism, 
including a national research registry, to ensure the transparent, in-
depth monitoring of federally funded and federally regulated stem cell 
research and to promote high ethical, moral, and quality research 
standards.
  No. 9, require ongoing, independent scientific and ethical review. We 
need to establish an ongoing scientific review of stem cell research by 
the Institute of Medicine and create an independent Presidential 
advisory panel to

[[Page 13584]]

monitor evolving bioethical issues in the area of stem cell research. 
In addition, we need to require the Secretary of Health and Human 
Services to report to Congress annually on the status of Federal grants 
for stem cell research, the number of stem cell lines created, the 
results of stem cell research, the number of grant applications 
received and awarded, and the amount of Federal funding provided.
  Lastly, No. 10, strengthen and harmonize fetal tissue research 
restrictions. Because stem cell research would be subject to new, 
stringent Federal requirements, I believe we must ensure that informed 
consent and oversight regulations applicable to federally funded fetal 
tissue research be made consistent with these new rules.
  During the past several months, rarely has a week passed without a 
newspaper story or scientific publication about possible research 
breakthroughs involving adult or embryonic stem cells--and the ethical 
issues raised by this research. Today, Americans' thoughts on stem cell 
research are debated on Sunday talk shows; photographs of microscopic 
blastocysts grace the cover of our nation's news magazines; and--twice 
in the last week alone--we have been reminded by those on the 
unregulated medical research frontier that human cloning and the 
creation of embryos for research is no longer relegated only to the 
realm of science fiction.
  Across the country, families are discussing the difficult moral 
issues that are raised by stem cell research around their kitchen 
tables. At their offices, co-workers are weighing the potential 
benefits of stem cell research against its morality. And many of my 
colleagues are personally grappling with the difficult decision of how 
best to approach these issues.
  An explosion of medical and scientific innovations are producing new 
treatments and hope for patients suffering from a wide range of 
disease. This has been accompanied by a newfound awareness among 
policymakers, and the public, of the potential of biomedical research--
an awareness that has spawned an insatiable appetite for more and 
faster advances. As a physician and a researcher, I am honored to have 
played my part in this movement--helping to foster broad, bipartisan 
support for increasing funding for biomedical research and, 
specifically, for the National Institutes of Health (NIH).
  However, we must always remember that science should not be practiced 
in a vacuum. And, with the ever-increasing pace of progress has come 
new challenges--posed by a variety of ethical dilemmas--that have, at 
times, outraced the ability of public policy and we, as legislators, to 
respond. Yet, I deeply believe that we have an obligation to do just 
that.
  There are those, I believe, who would tell us that ``politics'' 
should not impinge on the scientific process. As a legislator and a 
medical researcher, I can tell you that is not the case. Rather than 
leaving the progress and the ethics of science only to be determined by 
researchers and bioethicists, ``politics'' should, and does have, an 
important role in deciding what research is not only scientifically 
promising but also societally acceptable. This role is to determine, as 
the Washington Post noted several years ago and as I have referred to 
since, ``is there a line that should not be crossed, even for 
scientific or other gain, and if so, where is it?''
  Moreover, politics and policy plays a crucial role in guiding and 
ensuring the ethical pursuit of science, as well as restraining the 
inclination of science, left unchecked, to move beyond ethically 
acceptable boundaries. That, then, is our challenge.
  Today we are faced with the issue of embryonic stem cell (ES) 
research--research that carries both great promise and great peril. 
Most of us have been made aware, by now, of the tremendous potential of 
embryonic stem cells for therapeutic advances for a variety of 
conditions--diabetes, Alzheimer's disease, Parkinson's disease, 
leukemia, spinal cord injuries, to name a few.
  Embryonic stem cells are derived from a five to six day old embryo, 
also called a blastocyst. By this stage, the embryo has formed two 
layers: the inner cell mass which will form the embryo proper and the 
extra embryonic tissues that form the placenta and supportive cells. 
Although these inner cells, roughly 20-30 cells, have lost the ability 
to form supporting tissues, they retain the ability to develop into any 
cell type found in the body and are considered ``pluripotent.'' Over 
time and if allowed, they continue to multiply and differentiate 
further, becoming committed to specific lineages. It is from these 
inner cells found in the blastocyst stage that embryonic stem cells are 
derived. Such pluripotent embryonic stem cells, when properly isolated 
and cultured, appear to contribute to all cell types found in the adult 
and to be capable of indefinite self-renewal.
  These embryonic stem cells being discussed here are obtained from 
embryos left over following the conclusion of in vitro fertilization 
(IVF). Many of us have known couples who, because of their inability to 
have children through natural reproduction, have turned to IVF as an 
alternative. Since its introduction to the United States in 1981, more 
than 45,000 babies have been born using IVF procedures.
  However, because of the significant implantation failure rate 
involved in infertility treatment, current IVF techniques require 
couples to create more embryos than initially needed as a sort of 
insurance policy. Typically, physicians will obtain roughly 10 eggs. Of 
these eggs, only six to eight will become fertilized--producing an 
embryo. Then, in order to avoid producing multiple-fetus pregnancies, 
physicians will only transfer 2-3 embryos to the uterus. Those not used 
may be frozen for later use or donated for adoption. In fact, many 
couples decide to leave embryos frozen, in case they decide to have 
additional children, rather than beginning the entire process again.
  Adult stem cells, by contrast, are relatively undifferentiated and 
self-renewing cells that help repair tissues harmed by injury, disease, 
or natural cell death. The most widely known and understood example of 
such a cell is the hematopoietic stem cell, found in bone marrow and 
responsible for the production of blood cells. Other promising cell 
types include neural stem cells and mesenchymal stem cells. There have 
also been publications touting the potential of stem cells found in 
human fat tissue as well as umbilical cord blood. Until recently, adult 
stem cells were considered to be very rare, if they even existed, and 
inflexible--only able to form the cell types for the tissue in which 
they were found. However, recent news suggests adult stem cells may 
have more plastic properties than previously believed.
  Both embryonic and adult stem cell research hold tremendous potential 
for a wide range of uses, including clinical applications of cell-based 
therapies for a number of diseases and injuries. This research may be 
useful in providing scientists a better understanding of the human 
cellular growth and differentiation process--allowing researchers to 
seek out and attempt to treat or prevent the causes of birth defects 
and genetic abnormalities and diseases. It may also be useful in 
pharmaceutical development, allowing researchers to grow large numbers 
of various cell types in order to test drug effectiveness and toxicity.
  However, it is important that advocates not over-sell the potential 
of either embryonic or adult stem cell research for medical treatments. 
This evolving science is relatively new, and much basic research 
remains before we can reasonably expect to see clinical trials and 
possible treatments. In fact, to date, with the exception of 
hematopoietic stem cells that have been used in bone marrow 
transplantation for many years, none of these sources has yet 
demonstrated proven therapeutic applications.
  Some of the challenges that remain for both adult and embryonic stem 
cell research include: learning the signals that control the 
differentiation of stem cells into a desired type; overcoming the 
challenge of immune rejection in cell transplantation; and establishing 
consistent, effective methods to culture, isolate, and grow the cells 
in a timely manner that is consistent with

[[Page 13585]]

good manufacturing processes. Yet the hope that they will someday yield 
therapies for those suffering from chronic and debilitating and life-
threatening diseases is powerful.
  In my work as a physician and heart and lung transplant surgeon, I 
have for years wrestled with decisions involving life, death, health, 
and healing. Having taken part in hundreds of organ and tissue 
transplants, I've experienced the ethical dilemmas involved in end-of-
life care on numerous occasions. I have seen families faced with the 
most difficult decision of saying farewell to a loved one. Yet I have 
also seen their selfless acts in the midst of this sadness to consent 
to donate living organs and tissues of their loved ones to benefit the 
lives of others.
  Moreover, having performed surgery in the early days of heart and 
lung transplantation, I know the powerful impact that medical progress 
has had on each of my patients, many of whom are alive today because of 
the life-saving treatments developed through medical research.
  Because of my professional experiences, I have, during my nearly 
seven years in the United States Senate, devoted a significant portion 
of my time to address health policy issues as a way to impact patients 
on a broader scale than the one-on-one interaction which I knew 
previously. However, this effort has remained guided by the same basic 
principles that informed my career as a practicing physician and 
scientist--to improve the lives and health of patients and deeply 
respect the dignity of life.
  During the past few months, I have read much of the medical, 
scientific, and ethical literature relevant to this debate. I have 
queried my colleagues in the scientific and medical community who have 
first-hand experience with stem cell research, reproductive treatments, 
and the ethical issues enmeshed in each. I have talked with 
bioethicists. I have reviewed my own professional medical experience 
for guidance. I have examined federal public policy precedents 
involving medical research. And I have spent a great amount of time in 
prayer and reflection on this issue.
  As the Senate's only physician, and its only medical researcher, I 
feel compelled to explain to my colleagues and the American people my 
views on the proper public policy approach with respect to stem cell 
research. This is a critically important decision--one that cannot be 
left, as some have suggested, only to scientists--and it is vitally 
important that each of us is fully aware of the depth of the 
scientific, ethical, and moral issues involved.
  I mention that this issue should not be driven totally by the 
research community. Nor should it be determined solely by National 
Bioethics Advisory Commission (NBAC) commissioners or by patient 
advocates. Each of these stakeholders certainly has its role to play. 
The NIH has advocated on behalf of what they see as the direction in 
which science is heading. The NBAC has debated the issue and determined 
it worthy of Federal support. And patient advocacy groups have rightly 
worked to advance science that could benefit their particular 
illnesses.
  However, as a researcher, as someone who has participated in scores 
of clinical investigations on the transplantation of human tissues to 
benefit others, I know that this decision cannot be left to the sole 
jurisdiction of the scientific community. It is our responsibility as 
legislators to determine the proper role of our Federal government in 
this evolving, new research and to build in appropriate ethical 
safeguards.
  After grappling with the issue--scientifically, ethically, and 
morally--I believe that both embryonic and adult stem cell research 
should be federally funded within a carefully regulated, fully 
transparent framework that ensures the highest level of respect for the 
moral significance of the human embryo. Because the unique interaction 
between this promising but uncharted new science with the ethical and 
moral considerations of life is continually evolving and presenting new 
challenges, we must ensure a strong, comprehensive, publicly 
accountable oversight structure that is responsive on an ongoing basis 
to moral, ethical and scientific considerations.
  As a legislator, I have been consistent in my work to ensure that 
human life is treated with the utmost respect and dignity. I am pro-
life. My voting record in the Senate has consistently reflected my pro-
life philosophy. In my 6-plus years in the Senate, I have voted time 
and time again to preserve human life. For instance, I am proud to have 
been a leader in the fight to ban the partial-birth abortion procedure. 
As a physician, my sole purpose has been to preserve and improve the 
quality of life.
  Throughout my career on the forefront of heart and lung 
transplantation, I have had to face the ethics of life and death with 
my patients and their families. As a surgeon, I have frequently removed 
a heart from one individual whose brain has died and placed that heart 
into another patient who would otherwise die. But this requires 
determining when brain death has occurred a process that was very 
controversial when it was first developed just 33 years ago.
  A similar dilemma now confronts us in the field of embryonic stem 
cell research, and I have turned to my own experience as a transplant 
surgeon for wisdom. The question is much like that faced in the early 
days of organ transplantation--do we remove organs and tissue for 
transplantation and research from an individual who is brain dead, but 
whose other organs continue to live and function normally? Do we allow 
research using stem cells derived from blastocysts that could, if 
implanted, become a fetus, but which the parents clearly have 
determined to discard? I believe this is the proper course, but only 
under the strictest of regulations to ensure a clear separation between 
the decision of whether to discard excess embryos or donate them for 
adoption and the option to donate such embryos for research.
  Scientifically, I consider human embryonic stem cell research to be a 
promising and important line of inquiry. I am fully aware and 
supportive of the advances being made each day using adult stem cells. 
However, it seems clear that research using the more versatile 
embryonic stem cells does have greater potential than research using 
adult stem cells and may, under carefully considered and appropriate 
conditions, be conducted ethically. The scientifically prudent course 
for us as policymakers seems to provide for the pursuit of both 
embryonic and adult stem cell--research allowing researchers in each 
field to build on the progress of the other.
  Let me make this clear, however. To say that the research may 
ethically be conducted is not to say that the guidelines promulgated by 
the National Institutes of Health (NIH) are sufficient, as some of my 
colleagues have asserted. To the contrary, they are severely lacking in 
appropriate safeguards. Nor do any of the present versions of 
legislation pending in Congress to authorize ES research include 
sufficient protections.
  Therefore, federal funding for stem cell research should be 
contingent on the implementation of a comprehensive, strict new set of 
safeguards and public accountability governing this new, evolving 
research--to ensure the progress of this science in a manner respectful 
of the moral significance of human embryos and the potential of stem 
cell research to improve health.
  I transplant hearts and lungs. I spent 20 years in both medical 
training and engaged in surgery. I am board certified in two surgical 
specialties. I have spent countless hours research and publishing this 
research in peer-reviewed medical journals. I was active in clinical 
transplantation. In each case, families of the donor individual has 
completed a comprehensive informed consent process giving consent to 
organ donation. I would weekly get calls in the middle of the night 
summoning me to the operating room, where I would come face-to-face 
with individuals near death and their grieving families. Through these 
experiences, I have seen firsthand the impact that medical progress and 
technological have had in reshaping legal and ethical criteria, and, in 
turn, I have seen how ethics has shaped the practice of medicine.

[[Page 13586]]

  Historically, death was not particularly difficult to determine or 
define. Generally, all vital systems of the body--respiratory, 
neurological, and circulatory--would fail at the same time and none of 
these functions could be prolonged without the maintenance of the 
others. With major technological advances in life support, particularly 
the development of ventilators, it is possible to keep some bodily 
systems functioning long after others have ceased.
  Over time, most state laws adopted a neurological standard for 
determining when death occurs. Thus, it has become common, accepted 
practice that requires that both the cerebral cortex and the brain stem 
irreversibly cease to function--this is the so-called ``whole brain 
death'' standard. There is now broad public support for organ donation 
upon this basis. But the interplay of science, ethics, and policy did 
not come easily.
  As we came to no longer face the inevitable simultaneity of systemic 
failures, it became necessary to define with greater precision which 
physiological systems are indicators of life and which are not. In 
1968, a Harvard Medical School special committee report first urged 
that brain death be used rather than the older definition of 
irreversible circulatory-respiratory failure. This was later embraced 
by a Presidential Commission in 1981 as a recommendation for state 
legislatures and courts.
  In this context of life and death decision-making, physicians remove 
organs from individuals for the purpose of organ donation based upon 
the informed consent of families after determination of ``brain 
death,'' at which time the individual is considered to be dead. 
However, this decision-making process is carefully protected to ensure 
that the decision to withdraw life support or declare brain death is 
made entirely independent of any consideration of obtaining the 
individual's organs for donation. Even though the body and other organs 
and tissues are technically alive with the assistance of ventilators 
and other medical devices, the brain has ceased to function. When I 
removed a heart--or a heart and lungs--other organs were living and 
still functioning. Their organs would be used to save the lives of 
others. If the family consents following a comprehensive and broadly 
accepted consent process, we permit surgeons to remove living organs 
from the body of the individual.
  The decision to donate the organs of brain dead individuals is, as it 
should be, a decision separate from all other medical decision-making. 
It is made by informed consent of family to carry out the intent of the 
individual. It meets both ethical and practical requirements. First, it 
ensures that families are not faced with this difficult decision at a 
time when they are already struggling with saying good-bye to a loved 
one. It ensures that the treating physician is not the individual 
approaching the family for consent. On a very practical, public policy 
level, it strengthens the organ donation procedure by reassuring the 
public that decisions of best medical treatment are clearly divorced 
from the considerations of organ donation.
  The example of organ and tissue donation holds one framework to 
review in fashioning an approach that both respects the human embryo 
and promotes this new, evolving research. I believe that the human 
embryo is inherently valuable and has moral significance regardless of 
whether it will be implanted in a woman's uterus or is left-over in the 
colder, artificial setting of an infertility clinic. Because an embryo 
holds a high measure regardless of status, that embryo should be 
afforded a high level of respect.
  Because embryonic stem cells appear capable of indefinite self-
renewal and differentiating into all adult cell types, this research 
has tremendous potential to provide new, important cell-based 
therapies.
  Research using adult stem cells also holds tremendous promise for 
treating disease, and recent studies have altered long-held conceptions 
about the abilities and usefulness of adult stem cells. However, there 
appear to be characteristics--in particular, that they appear to have 
more limited life spans, are presently more difficult to isolate in 
useful quantities, and may not be able to form all cell types--that may 
limit the potential of adult stem cell research. However, it does 
appear that adult stem cells may be able to be manipulated on a scale 
previously thought impossible. Moreover, the apparent differentiation 
limitations placed on adult stem cells may indeed pose an advantage 
over embryonic stem cells.
  Nonetheless, it appears clear that research using adult stem cells 
does not hold the same potential for medical advances as does the use 
of the more versatile embryonic stem cells. But, as in all research 
endeavors, what we are considering is the potential for advancements. 
Scientifically, we will see the best advances in both adult and 
embryonic research by allowing the two to proceed along parallel 
tracks, fostering valuable collaboration and interplay between 
researchers on each side.
  Some of my colleagues have advocated that the guidelines promulgated 
by the National Institutes of Health provide a sufficient framework to 
ensure that embryonic stem cell research can be conducted ethically. I 
strongly disagree. On the contrary, I find the NIH guidelines lacking 
in appropriate safeguards.
  Therefore, Federal funding for stem cell research should be 
contingent on the implementation of a strict new set of safeguards and 
public accountability governing this new, evolving research. The 
following 10 points are essential components of a comprehensive 
framework that allows stem cell research to progress in a manner 
respectful of the moral significance of human embryos and the potential 
of stem cell research to improve health.
  One, require a rigorous informed consent process: To ensure that 
blastocysts used for stem cell research are only those that would 
otherwise be discarded, require a comprehensive informed consent 
process establishing a clear separation between potential donors' 
primary decision to donate blastocysts for adoption or to discard 
blastocysts and their subsequent option to donate blastocysts for 
research purposes. Such a process, modeled in part on well-established 
and broadly accepted organ and tissue donation practices, will ensure 
that donors are fully informed of all of their options.
  As with organ and tissue donation, we must first ensure that health 
care providers make no mention of the option to donate excess embryos 
until completion of infertility treatment and the decision has been 
made independently by both members of a couple to discard embryos 
remaining in frozen storage at the clinic. Once that decision has been 
made, the destiny of the embryos is certain. When couples make this 
decision and authorize a clinic to discard the embryos, it is clear 
that the embryos will be dead within a short time frame. Only after 
both members of a couple have made a firm decision to discard these 
additional embryos should health care providers or researchers be 
allowed to approach them about the opportunity to donate these embryos 
for use in research.
  Moreover, the NIH regulations should strengthen the informed consent 
process by requiring stronger informed consent. And regulations should 
ensure greater oversight and accountability in the derivation process 
by requiring site visits of labs where cell lines are derived and 
prospective approval of line derivations.
  Two, ban embryo creation for research: The creation of human embryos 
solely for research purposes should be strictly prohibited.
  Last week, researchers announced the creation of three ES cell lines 
derived from embryos created for the express purpose of research. 
Limiting federal funding to research using embryos left over after 
being created for reproductive purposes will not prevent the creation 
of embryos only for research purposes by unethical researchers. Such an 
action has been nearly universally decried from all quarters. 
Therefore, we should include a comprehensive ban on the creation of 
embryos through IVF for the sole intent of performing research.

[[Page 13587]]

  Three, continue funding ban on derivation: Strengthen and codify the 
current ban on federal funding for the derivation of embryonic stem 
cells.
  While we find it important to scientific research and ethically 
acceptable that limited and strictly regulated ES research proceed, 
this does not mean that federal funds should be used in the derivation 
of ES cells. Rather, a continued ban on federal funding for the 
derivation of ES cells is a right and proper indication and 
acknowledgment that the American people are conflicted on the ethical 
and moral propriety of this issue and do not feel that the proper use 
of federal funds is in the derivation process.
  Four, ban human cloning: Prohibit all human cloning to prevent the 
creation and exploitation of life for research purposes.
  Ban all uses of human cloning. Most are agreed in their opposition to 
reproductive cloning. It is important, however, to also ban non-
reproductive or research cloning both for the practical, implementation 
reason of making it more likely that such a ban on reproductive cloning 
will be successful as well as for the broader moral reasons shared by 
the majority of the American people that human embryos should not be 
created for the purpose of research and exploitation.
  Five, increase adult stem cell research funding: Increase federal 
funding for research on adult stem cells to ensure the pursuit of all 
promising areas of stem cell research.
  Although not presently as scientifically promising as ES research, AS 
research has seen many advancements in recent years and holds important 
potential for treating disease and injury. Many scientists have noted 
that not enough science has been completed to determine which of the 
two lines of inquiry will produce therapeutic applications and that it 
is therefore scientifically premature to limit research to one type of 
research only. Accordingly, in funding ES research, it is important to 
see that this is done in a manner complementing ongoing AS research so 
that both lines of inquiry are pursued aggressively and that neither is 
pursued to the scientific detriment of the other.
  Six, provide funding for embryonic stem cell research only from 
blastocysts that would otherwise be discarded: Allow Federal funding 
for research using only those embryonic stem cells derived from 
blastocysts that are left over after in vitro fertilization (IVF) and 
would otherwise be discarded.
  Specifically, the regulations should allow the use only of embryos 
that were created but unused for infertility treatment. These may only 
be donated from IVF clinics following completion of infertility 
treatment. Regulations should also include safeguards to prevent 
unethical creation of embryos in excess of clinical need.
  Seven, limit number of stem cell lines: Restrict federally funded 
research using embryonic stem cells derived from blastocysts to a 
limited number of cell lines. In addition, authorize Federal funding 
for stem cell research for five years to assure ongoing Congressional 
oversight.
  Limiting the number of cell lines would allow Federal funding to 
jumpstart the research into the basic properties of ES cells for more 
in-depth discovery of the capabilities, shortfalls, and properties of 
these cells, while respecting the ethical sensitivity of the research 
to the American people. Moreover, numerous researchers have expressed 
concern that, because existing embryonic stem cell lines would not be 
in accord with the present guidelines and regulations laid down by NIH, 
additional cell lines will have to be created. By limiting the creation 
of cell lines, the research will go forward, but under strong 
restrictions.
  Eight, establish a strong public research oversight system: Establish 
appropriate public oversight mechanisms, including a national research 
registry, to ensure the transparent, in-depth monitoring of federally 
funded and federally regulated stem cell research and to promote 
ethical, high quality research standards.
  A national research registry would serve as a holding and 
distribution facility that would provide another level of Federal 
oversight and control in the process. The registry would also be able 
to serve an important role of tracking the progress of this research as 
well as providing a strong oversight mechanism to track the research 
and its attention to public regulations.
  Nine, require ongoing, independent scientific and ethical review: 
Establish an ongoing scientific review of stem cell research by the 
Institute of Medicine (IOM) and create an independent Presidential 
advisory panel to monitor evolving bioethical issues in the area of 
stem cell research. In addition, require the Secretary of Health and 
Human Services to report to Congress annually on the status of Federal 
grants for stem cell research, the number of stem cell lines created, 
the results of stem cell research, the number of grant applications 
received and awarded, and the amount of Federal funding provided.
  Stem cell research is so significant both ethically and 
scientifically, that continued Congressional oversight is important. 
All of this research should be the subject of ongoing scientific and 
ethical review.
  Ten, harmonize restrictions on fetal tissue research: Because stem 
cell research would be subject to new, stringent Federal requirements, 
ensure that informed consent and oversight regulations applicable to 
federally funded fetal tissue research are consistent with these new 
rules.
  These principles provide for an appropriate amount of research using 
human embryonic stem cells but ensure that such research is not 
conducted to the detriment of research utilizing adult stem cells. They 
balance the desire to move this research forward on a greater scale 
with the imperative to maintain the highest level of oversight to 
prevent abuses and the importance of continuing Federal oversight as 
this research advances.
  These 10 principles help answer the question I posed earlier: ``Is 
there a line that should not be crossed even for scientific or other 
gain?'' The clear response is ``Yes.'' It is clear to me that the 
creation of human embryos for research purposes should not be 
undertaken, regardless of the potential for scientific gain. It is 
clear to me that the use of human cloning should be strictly prohibited 
to prevent the commoditization and exploitation of human life. It is 
clear that the present restriction on the use of Federal funds for the 
derivation should be maintained and strengthened to reflect the 
concerns of the American people.
  I know that many people with deeply held views on this issue will 
disagree with some portion of the position I have outlined today. 
Others may attempt to divorce certain of these issues from 
consideration of the others.
  This should not be done. The fact is that these issues--of stem cell 
research, the creation of embryos, human cloning, public restrictions 
on the scope of research broadly are all pieces of a larger whole.
  By pursuing the policy framework I have laid out today, we can help 
set the stage for groundbreaking research with the potential to help 
untold millions of Americans and individuals worldwide. We will have 
laid a firm foundation for that research to succeed--a foundation 
without which the goal of seeing treatments through embryonic stem cell 
research will falter on the fears and uncertainties of Americans. This 
framework provides that firm ethical foundation instilling confidence 
in comprehensive and transparent oversight ensuring that such research 
is conducted with close attention to the difficult ethical and moral 
issues involved.
  We must define the role of the Federal Government in harnessing this 
technology for good. Our task as citizens is to exercise responsible 
stewardship of the precious gift of life. This effort represents a 
first step in this process.
  Mr. President, I look forward to continued participation in this 
dialog on embryonic and adult stem cell research.
  The PRESIDING OFFICER. The Senator from Texas.
  Mrs. HUTCHISON. Mr. President, I ask the Senator from Tennessee if he

[[Page 13588]]

needs further time to finish his statement. His statement was very 
thoughtful, and this is a crucial issue facing our country. If he would 
require added time, I would be happy to yield.
  Mr. FRIST. Mr. President, I appreciate the offer of the Senator from 
Texas. I believe my statement will complete my thoughts. I do look 
forward to continued participation of all of us. She and I were both in 
a hearing a few minutes ago talking about this very issue.
  Mrs. HUTCHISON. Mr. President, I appreciate very much what Senator 
Frist, who is the only physician in the Senate, is contributing to the 
issue of stem cell use for research purposes. We have just spent 
several hours in a hearing learning from scientists and many others 
about the differing viewpoints on the need for the use of stem cells 
for research into many diseases where it is hoped we can find an answer 
through the use of these embryonic stem cells. The debate is valid.
  Senator Frist has pointed out some of the legitimate ethical 
questions. I hope we can move forward in a way that does increase the 
ability to use these types of stem cells and cord blood for looking 
into the causes and, more importantly, even the treatment of some of 
the cancers and diseases, such as Alzheimer's, Parkinson's disease, 
multiple myeloma, many forms of cancer where there is great hope that 
we might have treatment that would allow people to live healthy lives, 
normal lives, with this kind of treatment, even though they have these 
diseases.
  I thank the Senator from Tennessee for his thoughtful contribution to 
this debate.

                          ____________________