July 29, 2005

Dear Colleagues:

The following is Senator Frist's statement on stem cell research legislation, as prepared for delivery this morning. His statement is a very important and good development for the scientific community. Our thanks go to the members of our faculty and of our Government Affairs staff who played a role in educating members of Congress about the potential of stem cell research, and we are pleased that the Coalition for the Advancement of Medical Research (CAMR) already has announced its support of Senator Frist's statement.
Edward D. Miller, M.D.

Senator Frist's Remarks on Stem Cell Research
Since 2001 when stem cell research first captured our nation's attention, I've 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's 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 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's why we must get our stem cell policy right -- scientifically and ethically. And that's why I stand on the floor of the United States Senate today.

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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'll 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 four 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 5th principle as I presented it on this floor four 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. Provide 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 four 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.

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I'm a physician. My profession is healing. I've 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've 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's 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.

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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.

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During the past several weeks, I've 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 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.

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I am pro-life. I believe human life begins at conception. It is at this moment that the organism is complete -- yes, immature -- but complete. An embryo is nascent human life. It's genetically distinct. And it's biologically human. It's living. This position is consistent with my faith. But, to me, it isn't just a matter of faith. It's 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.

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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're 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 non-harmful 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.

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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'm a cosponsor of a bill that will make it much easier for patients to receive cord blood cell treatments.

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Adult stem cells are powerful. They've 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're 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.

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That's why I believe it's 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 complicated parliamentary maneuvers. I've been working to bring this about for the last few months. I'll 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've 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. Policy makers, similarly, should not overpromise and give false hope to those 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's time for a modified policy -- the right policy for this moment in time.