Mr. President, I thank both of my colleagues for the superb comments thus far over the last 30 minutes but, indeed, since we started at 12:30 today. As I opened this morning, I made it clear that this debate would be the first of the…
Mr. President, I thank both of my colleagues for the superb comments thus far over the last 30 minutes but, indeed, since we started at 12:30 today.
As I opened this morning, I made it clear that this debate would be the first of the 21st-century dilemmas that involve ethical considerations and considerations around science, probably the first of many. I say the first; obviously, we have dealt with some other ethical issues in medicine over the last 5 years, but much of the discussion will focus around science and ethics and that nexus, that crossing of those two, and the interplay.
It is important that we debate this and that all concerns are put on the table, ultimately. These three bills give that opportunity.
Let me add that this probably will be the first of many debates like this in the Senate. I know there are a lot of my colleagues who asked: Why are we bringing this up now? Why are we talking about these tough issues which do force us to address issues about the distinctions of life, the early days of life and also the hope and the promise of science as it goes forward and that interplay? This Senate will have to get used to it.
This Senate will have to focus on those issues as we move forward because science, where it used to be growing at a small clip, is now growing at leaps and bounds, not exponentially but close to exponentially, and will continue to do so.
Less than a century ago, we did not have antibiotics, we did not have vaccines. We had measles, mumps, smallpox, polio--all diseases that ravaged our populations, in this country and around the world. Because of science, because of public health initiatives, they have essentially been eradicated. We will see forward momentum. That momentum will be accelerated in biomedical research.
I mentioned earlier today in opening the debate that when people look back at the 21st century, I would say maybe the next decade is the decade of the cells. Much of our discussion is about developmental biology. That has built upon the foundation of the shoulders of new knowledge regarding molecular and cellular development, coupled with the new understanding that is a product of a sequencing of the human genome from a decade of the last century.
What is important is that the rules, regulations, guidelines, and the framework must be defined and in large part must be defined by this Senate. That is our responsibility as Senators, as representatives of the American people, their attitude, their thought, their philosophies. They are our constituents.
A second point I made when I first started talking about stem cell research 5 years ago is we will have to continually assess and then reassess in light of advancing science certain rules, guidelines, and regulations we put in place. In part, that is why we are here today.
We have three bills before the Senate. My colleagues have talked about those three bills: the Fetus Farming Prohibition Act, the Alternative Pluripotent Stem Cell Therapies Enhancement Act, and the Stem Cell Research Enhancement Act. Each addresses a different facet of the issues raised by advancing research, advancing developmental biology, advancing stem cell research. Each one of them demands thoughtful consideration and deliberation which will play out over the course of today and tomorrow.
I spent my entire professional career as a transplant surgeon, a professional who specializes in moving living tissue from one person to another person--say an organ or a heart. Take out a heart, put in a heart. Take out a lung, put in a lung. Thus, my interest before coming to this Senate focused on many of the same issues that come before the Senate today: advancing science, how do we define ``brain death,'' something we did in the 1960s, to make transplantation of the human heart possible.
Thus, it was a little over 5 years ago--on July 18, 2001--that I laid out a comprehensive proposal, a framework at that time, which I believed would both promote stem cell research but also provide an ethical framework through which such research could be conducted. That was 2001, about 2\1/2\ years after embryonic stem cells had just been discovered by James Thomson at the University of Wisconsin, or the human embryonic stem cells.
At that time, 5 years ago, I laid out 10 specific interdependent principles. The principles dealt with all types of stem cell research-- the adult stem cells, the germ stem cells, embryonic stem cells. They have helped to guide my assessment of stem cell research over the last 5 years, and they have provided a framework I have used and consistently gone back and adopted as I looked at various pieces of legislation on stem cells before this Senate. I will read those 10 principles because of their inclusiveness and their interdependence:
No. 1, ban embryo creation for research.
No. 2, continue funding the ban on the derivation.
No. 3, ban human cloning.
No. 4, increase adult stem cell research.
No. 5, provide funding for embryonic stem cell research only from blastocysts that would otherwise be discarded.
No. 6, require a rigorous informed-consent process.
No. 7, limit the number of stem cell lines.
No. 8, establish a strong public research oversight system.
No. 9, require ongoing independent scientific and ethical review.
No. 10, strengthen and harmonize fetal tissue research restrictions.
The principles are meant to stand the test of time even when applied to a field as rapidly changing as stem cell research.
Yes, I do believe both embryonic and adult stem cell research should be Federally funded but should only be done so within a carefully regulated, fully transparent, fully accountable framework, ensuring the highest level of respect for that moral significance of the human embryo. But we should fund research when it comes to embryonic stem cell research only if those embryos, only if those stem cell lines were derived from blastocysts that, with 100 percent certainty, are not going to be frozen forever, are not going to be adopted but with 100 percent certainty and with appropriate consent would be discarded, would be thrown away.
Today, we do debate science, developmental biology, and we debate ethics. We are called upon to confront the distinctions around life's early goings when we do so. As my colleagues know, I am pro-life. I do believe human life begins at conception. It is at this moment, at conception, that the organism is complete--immature, yes, but complete. It is genetically distinct, it is biologically human, living. Development is a gradual process, it is a continual process. All of us in this Senate were at one time an embryo. It represents human life at its earliest stage of development. It is a continuum, coming all the way through. That is the science. That is not religion. That is not faith. That is the science. Thus, I believe strongly that an embryo does have moral significance. It needs to be treated with the utmost dignity and respect.
We have three bills before the Senate. The Fetus Farming Prohibition Act of 2006, the implantation and gestation of the human embryo into either a human or an animal for the purpose of aborting for research-- that prohibition is what the discussion is about. Clearly, that would fall far short of ``utmost dignity and respect.''
The bill before the Senate ensures this practice is never employed in human research in the United States. That purposeful development of a human embryo, the manufacturing of human life for experimentation and its ultimate destruction is morally reprehensible. It offends the conscience, degrades the value of human life, and, of course, is not medically necessary. Yet it is a practice that some in the field of developmental biology just might be inclined to pursue if those guidelines, if those regulations, are not out there. Why? To look at the later stages beyond the embryo in terms of development and how cells function, or it might be, as we have heard argued before, that the cells have a different nature after the embryo stage but before delivery of the fetus itself and have more stability or more differentiation. This particular legislation preempts, it stops that possibility.
Not only would this be a flagrant lack of respect for nascent human life, but it would also create powerful incentives for women to undergo an intense regimen of superovulation drugs and surgery with potentially devastating side effects. It could exploit women, the most likely targets of egg harvesting or fetal farming. Under no circumstances could human fetus farming be labeled ``medical advancement.'' It is the exact opposite, an unconscionable regression of the mores that define our culture, a culture that upholds respect for life and health.
As a transplant surgeon, I have had that opportunity to see firsthand how new medical discoveries and technologies can save lives and make life more fulfilling for others. In fact, my entire professional career was spent on these newer therapies, these newer technologies, in order to give others a better life. But at the same time, whether it is in the laboratory, where I spent a lot of time, or at the bedside, I have been able to also witness how fear can also delay scientific advances that are out there before us.
So before us today is that challenge to bridge this divide. And we should reject an outright fear of all technological advance. We have to work together to allow science to advance and to promote those medical advances, whether it is in developmental biology or the human genome project, in order to give a healthier life or more life to others. But we have to do so. That is why we bring these bills to the floor, within an ethical and moral framework, in this pursuit.
Even while we reject a fear of scientific and technological advancement, we still have to--we must; it is our responsibility--live within limits. Limits do not hamper human advances but, rather, allow us to preserve them and to promote them. That is why we can reject this practice of fetus farming while still embracing the hope that is offered by stem cell research. Senators Brownback and Santorum worked hard to bring this important legislation to the floor, and I hope my colleagues will join me in supporting it.
The second bill, the Alternative Pluripotent Stem Cell Therapies Enhancement Act, put forth by Senators Santorum and Specter, is a very important bill, the purpose of which is to step back from and to remove the ethical considerations that surround the unique potential that these pluripotent stem cells have.
Five years ago, when I came to the floor in 2001, I said the following:
We should not let the potential of this research drive the
moral considerations themselves. . . . We do not know what
the next great discovery is going to be 6 months from now. .
. . So the oversight process has to be responsive, has to be
ongoing. It has to recognize that science moves very quickly.
That is why we are here. We recognize that science cannot be practiced in a vacuum. We need to promote and accelerate these medical advances. But we also need to ensure that research practices are channeled along lines that respect human life and dignity.
What seemed impossible even 5 years ago now seems possible. Exciting techniques are beginning to emerge that just may make it unnecessary to have to destroy that embryo, to disaggregate or dismember that embryo, in order to obtain cells that have the pluripotent properties that are either exactly like or very similar to the embryonic stem cells. And we have talked about it a little bit earlier today, and in the past, as to the unique property these embryonic stem cells have, which is this pluripotentiality, which has two concepts to it: No. 1 is that they can become any tissue--theoretically, they can become any tissue--and that is in the differentiation; and, secondly, this overall process of self- renewal, that they can renew and replicate themselves again and again and again.
An adult stem cell might be reprogrammable. You might be able to directly reprogram that cell to an earlier stage to make it more pliable, to take it back to an earlier or closer to an embryonic phase. Adult stem cells can be what we call multipotential, and that means they can differentiate, and you can back them down to differentiate into certain tissues. The embryonic stem cell is pluripotential, and the range of tissues it can differentiate to are much greater.
But this reprogramming, coming back earlier to the adult stem cell, earlier and earlier along its chronological development, gives the opportunity to send that adult stem cell into various regions; thus, this direct reprogramming concept opens up great potential. To me, and I would hope to every Member of this body, this type of research-- research that stops short of having to destroy an embryo--to obtain pluripotent cells through alternative ways should be supported, and I hope can be supported, by everybody in this body.
In May of last year, 2005, the President's Council on Bioethics issued a report bringing these alternative sources attention. At that time, I asked and worked with several of my colleagues to put together a piece of legislation for which we could say Federal funding will go in that direction to derive these alternative means of developing these pluripotential cells. With more Federal support, and with more emphasis, these newer methods may pay off hugely in terms of scientific advantage and clinical advantage.
They may be the way to bridge these moral and ethical differences among people who hold wildly different and broadly different views, which we will actually hear on the floor over the course of today and tomorrow on stem cell research. Why? Because they avoid any destruction of the human embryo. The alternative methods of potentially deriving pluripotent cells, that were spelled out in the Council on Bioethics report of May of last year, include: extraction from embryos that are no longer living; a second proposal was blastomere extraction, which involves a nonlethal and nonharmful extraction of the blastomeres from embryos--and, indeed, several researchers over the course of the last year, since that proposal was initially made, have reported success in that regard--thirdly, extraction from artificially created organisms that are not embryos, but embryolike--this was initially proposed by Bill Hurlbut at Stanford and subsequently demonstrated by Dr. Rudolf Jaenisch and others at MIT--fourthly, the direct reprogramming of adult or somatic cells to a pluripotent state through fusion with embryonic cell lines.
We are already driving and promoting ethical alternatives such as
adult stem cell research and therapies and cord cell research, both of which have been important to date in the treatment, as well as other types of therapy.
Today, adult stem cell research is the only type of stem cell research that has resulted in proven treatments for human patients. At the Multiorgan Transplant Center that I established and directed at Vanderbilt, we did bone marrow transplants, which are commonly done for treatment of many types of cancers now; at that point, for many types of blood disease. We have had bone marrow transplants done in this country for, oh, about 40 years. The first bone marrow transplant was done in 1968.
Stem cells taken from cord blood have shown great promise in treating the myeloproliferative disorders, the leukemias, congenital immune system disorders.
Recently, cord blood cells have shown some ability to become natural cells, which could lead to treatments for more heart disease and Parkinson's disease. The first cord blood transplant was done about 20 years ago in 1988.
So every day we unlock more of the mysteries of human life, more ways to promote and enhance our health. This compels the profound questions we address, moral questions with which we understandably struggle. Transplantation itself posed a question similar to those we face with stem cell research, a little bit different in that organs were transplanted principally, when I got started, at the end stage of life. People without a heart would be dying 4 to 6 months later. We had to define, as I mentioned earlier, what is brain death. We had ethical considerations about how to allocate a very few number of organs to the many people who waited, which literally meant some people would die waiting for that scarce organ--all ethical considerations.
If we can devise a moral and ethical framework, then it is my belief we will have the chance to save many lives and make many countless other lives more fulfilling. That is why it is imperative we get our stem cell policy right scientifically, morally, and ethically.
A lot of diseases have been mentioned on the floor, and I guess over the next 2 days I will have the opportunity to come back and talk about some of those particular diseases. Adult stem cells, we know, are so powerful. They have effectively treated so many diseases today. I mentioned bone marrow transplantation. But the list will be coming to the floor, and they have come to the floor, about the number of therapies with bone marrow transplantation and other adult stem cells. Embryonic stem cells, however, do have this unique capacity of self- replication, self-renewal over time, and greater potential to differentiate into other types of tissues. Unlike other stem cells, these embryonic stem cells are pluripotent, where adult stem cells tend to be multipotent. That means the embryonic stem cells have the capacity to become a greater range of types of tissues. They are capable of renewing themselves and replicating themselves over and over again indefinitely.
A number of people have brought up what the current administration policy is. As we all know, on August 9, 2001, President Bush laid out his principles and put in place a policy, which I supported, that for the first time allowed Federal funding for embryonic stem cell research. The President's policy was consistent with my initial principles--my seventh principle: to limit the number of stem cell lines. In order to accomplish that limiting the number of lines, the President used a date: August 9, 2001.
The President's policy also says: Let's support stem cell lines that have been derived from blastocysts that were going to be thrown away or discarded. His policy is the same in that regard. The cell lines we federally support today all came from blastocysts that were left over by in vitro fertilization that were going to be discarded. The President basically said it was OK to do that before August 9, but after August 9 that will not be allowed anymore, and we will only fund those cell lines.
I thought it was very important that Congress continue oversight. Remember, 5 years ago or 6 years ago, I said we are going to be coming back to this again and again and again. I think that oversight absolutely is critical.
This third bill, the Stem Cell Research Enhancement Act, which is the House-passed bill, the Specter-Hatch, the Castle-DeGette bill, is the bill most people will be spending most of their time on over the next day and a half.
Over the last 5 years--while it was widely believed when the President put forth his policy that there would be 78 embryonic stem cell lines available for Federal funding--we have learned, through science, that has not been the case. In fact, of the initial anticipated 78 lines, there are, right now, about 22 lines that are eligible. There is some concern that these lines are becoming less and less stable and less replicative than initially thought.
While we know that this embryonic stem cell research is at a very early stage--remember, these embryonic stem cells were discovered, first, just in 1998; unlike adult stem cells, where we have 40 years of research history--we do know that the embryonic stem cell research is moving fast and moving quickly.
The question is: Are there a sufficient number of cell lines to keep that research going? I believe right now that the current policy unduly restricts the number of cell lines. As I have said, I am going to be supporting and voting for H.R. 810, the Stem Cell Research Enhancement Act. I do not think it is an ideal piece of legislation. It has a few essential shortcomings as written. It restricts funding to blastocysts left over after IVF that would otherwise be discarded. And that is consistent with my fifth principle. But the shortcomings do have to be addressed somewhere.
First, it lacks a strong ethical and scientific oversight mechanism. Second, the bill does not prohibit financial or other incentives between scientists and fertility clinics. Third, the bill does not specify whether the patients or clinic staff or anyone else has the final say about whether an embryo will be implanted or will be discarded.
And were circumstances different and had the House not acted so quickly and sent the bill over--I think we should have had the opportunity to have a thorough examination and rewrite of that bill. However, even with those reservations, I do support the Stem Cell Research Enhancement Act. As I said, it is completely consistent with my principles from 5 years ago.
Many of my colleagues, such as I, have spent countless hours grappling with this issue--the future of stem cell research. How do we balance pro-life positions with the potential for new life and health offered by stem cell research? There is, perhaps, an inclination to avoid such difficult issues, to ignore them and let others debate. But I believe and feel strongly that we must participate in defining research surrounding the culture of life.
If we don't do that, it will define us. Finally, I thank all of my colleagues. I know we will have a good debate over the next day. We will have those votes at 2:45 tomorrow. I hope those votes will show there are areas of consensus among us and that where differences exist we can respectfully articulate and vote our conscience.
Mr. President, I ask unanimous consent the order for the quorum call be rescinded.