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[Page: S7846] GPO's PDF---
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 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
[Page: S7847] GPO's PDF
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 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.
[Page: S7848] GPO's PDF
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.
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