Fetus Farming Prohibition Act of 2006 - Part II
FETUS FARMING PROHIBITION ACT OF 2006 -- Part II -- (Senate - July 18, 2006)
BREAK IN TRANSCRIPT
Mr. HATCH. Mr. President, some aspects of this issue involve complicated scientific facts and complex moral questions. Elected officials and the American public alike have had much to learn and consider since this issue first arose on the scene in 1998.
The more the American public thinks about this issue, the more it coalesces around the policy embraced by H.R. 810 which will significantly improve and expand taxpayer supported stem cell research.
Public opinion polls show that U.S. citizens are squarely behind stem cell research and H.R. 810.
For example, a poll commissioned by the Coalition for the Advancement of Stem Cell Research and taken in May of this year found that 72 percent of Americans support embryonic stem cell research and 70 percent favor the Senate adopting H.R. 810, the Stem Cell Research Enhancement Act. This finding of broad public support is consistent with other previously conducted polls. For example, a Harris poll taken in August 2004 found that 73 percent of Americans think stem cell research should be allowed and a June 2004 Wall Street Journal/NBC News poll placed public support for this research at 71 percent.
Some may try to quibble about how particular poll questions were phrased in particular surveys, but few would question the fact that for some time most Americans have wanted the type of research that H.R. 810 will help enable to go forward.
I can tell you this. The poll results I have just cited are consistent with what I hear from my neighbors and constituents in Utah. I come from a conservative State. But whenever the issue of stem cell research comes up at one of my meetings in Salt Lake City or other places in my State, somebody will come up to me to tell me their personal story with the diseases of a loved one and tell me that I am doing the right thing on stem cell research.
One of the reasons why I got involved with the issue of stem cell research in the first place was because of a little boy named Cody Anderson, whose family used to live in West Jordan, UT.
Cody and his family came to visit me in Washington in 2001 to tell me their tragic family struggle with diabetes. Cody's grandfather succumbed to diabetes at age 47 after a series of painful amputation operations. Cody, his grandfather's namesake, never got the chance to meet or know his grandfather because of diabetes.
Let me read you part of a letter that Cody and his family wrote me:
I don't want other small children like me to have to go through the things that I have already had to go through. I do not want to suffer the effects that my grandfather did throughout his life because of this disease. I want to grow old and not have to worry about all the bad things that could happen to me because of diabetes. We have seen what diabetes can do to an innocent life. Please don't let this happen to me in my life now. I hope you will take it in your hearts to listen to us, the people who live with this disease for every minute of every day for now and the rest of our lives.
In a few hours we can pass a bill that can only help Cody and thousands of others suffering from diabetes and millions of others who suffer from other diseases and conditions that may benefit from stem cell research.
How do you think young Cody's parents felt when they learned of their son having the same diagnosis as his grandfather?
How would you feel if you were told that your child would lead a life revolving around multiple daily blood tests, insulin injections, and a tightly regulated diet and constricted activity schedule that no child would relish?
The answer of any parent is that you would want your government to leave no stone unturned in finding a cure for that disease. And you would want the cure found as soon as possible.
Let me say a few sobering words about the immediacy of the promise of stem cell research. Cures are not around the corner. While stem cell research may prove in time to be a revolutionary advance in science such progress does not come quickly or on the cheap.
If we start a vigorous program of federally funded stem cell research program progress will not likely be measured in hours and days. It will take years, perhaps 10 or 20 years, before American patients are administered a new class of products and treatments derived from stem cell research.
In this regard I am reminded of an instance in which, when advised that a certain type of rare plant took years and years to bloom if placed in a certain hostile environment, a great French General simply said, ``Then we must not delay, we must plant today.''
We have to proceed with stem cell research with a passion and urgency today precisely because we do not know how long it will take to find tomorrow's cure. But we do know that the sooner we start, the faster we will get there.
Nor will this research be inexpensive. No doubt one reason why the biotechnology industry is supporting H.R. 810 is because since the end of World War II basic biomedical research in this country has primarily been funded by taxpayers through the programs conducted or supported by the National Institutes of Health. Today, about 80 percent of the $28 billion NIH budget is invested in highly-competitive, peer-reviewed research that is undertaken by universities and research hospitals.
There has been a continuum of effort between the public sector basic research and private sector applied research that attempts to translate the new basic knowledge gleamed from federally supported NIH research into tangible FDA-approved products or other treatments before they can reach even the first patient's bedside. Americans should take pride in the fact that virtually every major advance in the biological sciences in the last 50 years emanated in some way from our investment in the NIH.
In my view, it would be in tragic and nearly incalculable mistake for our country to continue our present policy that materially constricts the cadre of investigators leading over 46,000 ongoing university based, NIH research grants from pushing the envelope of stem cell research. To cede our leadership in such a promising field of endeavor of biomedical research as stem cell research can only be shortsighted in the long run.
For example, the University of Utah is the proud home of one of the world's foremost mouse stem cell researchers. His name is Dr. Mario Capecchi and he has already won one of the most prestigious awards in American science, the Lasker Award. A great deal of the support for Dr. Capecchi and other researchers at the University of Utah and other research universities across the country come from NIH grants and contracts.
I want Dr. Capecchi to stay in Utah. I want the world's leading scientists to stay in the United States. It is critical to relax the current straitjacket on testing new stem cell lines if we are to keep the best stem cell researchers in this country.
Some might say good riddance to this research and to stem cell researchers. Look what happened in South Korea when a group of stem cell researchers conducted unethical experiments, faked the results and lied to the public.
I say that if the NIH is involved in this research and it is conducted in America, federally supported researchers will have to live within longstanding NIH ethical guidelines and principles as well as special rules that will apply only to stem cell research. In this way, as we have done so many times in the past with breakthrough research such as with recombinant DNA technology and organ transplants, the United States can help set a moral and ethical climate that our neighbors in the world community will emulate and follow.
I hope we never reach the day when the best biomedical researchers trained in America must go elsewhere to conduct the most cutting-edge basic biomedical research. Once that happens, we could face the day when sick Americans must actually leave our country to get the latest in treatments. I sure would not want to see a day when a citizen of Salt Lake City has to go to South Korea or any place else to get the best medical treatment possible.
Today, for all of its warts, the U.S.A. is widely recognized as the world's leader in developing and disseminating the latest in medical breakthroughs.
Passage of H.R. 810 will help us keep it that way.
The purpose of H.R. 810 is to expand the opportunities for the type of federally funded basic biomedical research that has proven so beneficial to the American public time and time again in the past.
Having described how many experts and interested parties believe that the promise of stem cell research is so great, I want to spend the next few minutes describing why some are opposed to this research and why I think their opposition is misplaced.
In order to do this, I feel compelled to spend a few minutes to define and discuss some technical scientific terms. I know that others have used many or all of these terms during the course of the debate but please bear with me if I am repeating some one or get too technical.
Perhaps the best place to start a discussion of stem cell research is with a broader term that many scientific experts believe more accurately describes the field and what is at stake.
The term is regenerative medicine.
Regenerative medicine seeks to uncover knowledge about how healthy cells contained in tissues and organs are formed and how they are lost through normal wear and tear or impaired more extensively through injury or degenerative disease.
The growing field of regenerative medicine is increasing our understanding of embryonic development, birth defects, organ transplantation, and the developmental biology of both healthy and diseased tissues. A key avenue of research of regenerative medicine involves stem cells. A stem cell is an undifferentiated cell that has the unique capacity to renew itself and give rise to specialized cell types. These stem cells are called pluripotent because of this ability to develop into different kinds of specialized cells, perhaps into all or most of the 200 known types of tissues that comprise the human body. Stem cells have the ability to divide and replicate for long periods of time in a laboratory colonies called cell lines.
The flexibility of these pluripotent stem cells is distinct from most cells in the body, because most cells are typically dedicated to performing a specific task such as heart muscle cells and specialized nerve cells. Scientists, like Dr. Kerr, the Johns Hopkins nerve cell researcher whom I talked about earlier, hope to be able to use stem cells to study how healthy and diseased cells work and, one day use this knowledge and use stem cell lines to treat or repair diseased tissues or organs. If this research is successful, many currently untreatable diseases and conditions may go the way of small pox and polio.
There are several different sources of stem cells.
Adult stem cells are undifferentiated cells that are found in specialized adult tissues. These cells can renew themselves and, with certain limitations, can differentiate to yield all the specialized cells types of the tissue in which they are found, and perhaps others as well. Adult stem cells have been found in many tissues including bone marrow, blood, the brain, skeletal muscle, dental pulp, liver, skin, eye, and the pancreas.
There is no serious opposition to adult stem cell research. I fully support this research.
There is, however, much debate over the potential limitations of adult stem cell research. For example, the seminal 2001 National Academy of Sciences study I mentioned earlier summarized the concerns:
(I)t is not clear whether ..... adult stem cells ..... truly have plasticity or whether some tissues contain several types of stem cells that each give rise to only a few derivative types. Adult stem cells are rare, difficult to identify and purify, and when grown in culture, are difficult to maintain in the undifferentiated state. It is because of those limitations that even stem cells from bone marrow, the type most studied, are not available in sufficient numbers to support many potential applications of regenerative medicine.
Although some opponents of H.R. 810 have taken exception to this characterization of the limitations of adult stem cells, it is my understanding that most experts in the field believe that embryonic stem cells offer advantages over adult stem cells because of the reasons I have just reported from the NAS study.
Moreover, some proponents of adult stem cell research claim that many diseases have been effectively treated with adult stem cells. Unfortunately, the weight of evidence does not support many of these claims. Nor do most of the leading experts in the field agree with the notion that adult stem cell research exceeds the promise of embryonic stem cell research despite the fact that adult stem cell research has at least a 40-year head start on embryonic stem cell research and has enjoyed a sustained funding commitment from the NIH.
The current issue of Science magazine contains a detailed letter written by three scientists, Shane Smith, William Neaves, and Steven Teitelbaum challenging claims made by a leading advocate of adult stem cell research, Dr. David Prentice. I understand that most experts come down on the Smith-Neaves-Teitlebaum side of the debate concerning the scientific limitations and opportunities of embryonic stem cells relative to adult stem cells.
Additional sources of stem cells are those acquired from placental and umbilical cord blood. Last fall the Congress passed and President Bush signed into law legislation that I co-authored to expand the use of the valuable and proven source of stem cell therapy. Due to the work of pioneers like Dr. Joanne Kurtzberg from Duke University and Dr. Pablo Rubinstein of the New York Blood Center, cord blood has become an important mode of treatment for diseases like bone marrow disorders and has proven to be particularly useful in the African-American community where it is often difficult to find suitable bone marrow matches.
Yet another source of stem cells is those derived from human embryos. Public debate and discussion have centered on two types of embryonic stem cells.
First, stem cells may be derived from embryos created for, but no longer needed in, the in vitro fertilization process.
Second, stem cells can potentially be derived from so-called cloned embryos through the process of somatic cell nuclear transfer.
Today's debate centers on the first source of embryonic stem cells--excess embryos formed in fertility clinics slated for destruction.
Under the terms of the unanimous consent agreement--and it is an agreement I fully support and commend Senators Frist and Reid for negotiating--the bills we debate today do not involve cloned embryos formed by somatic cell nuclear transfer. This is the process whereby the nucleus of an egg and its complement of 23 chromosomes is removed and replaced with the nucleus of one of the standard 46-chromosome containing somatic cells that constitute the 200-plus tissues of the human body.
Senator Feinstein and others have developed legislation that would ban and criminalize the act of using the somatic cell nuclear transfer process to give birth to a cloned human being. In addition, our bill, the Human Cloning Ban and Stem Cell Research Protection Act, S. 876, would set forth a tightly defined set of ethical restrictions and NIH oversight for anyone in the private sector that undertakes somatic cell nuclear transfer in order to produce new stem cell lines.
Others, led by Senator Brownback, have offered legislation that would effectively ban somatic cell nuclear transfer altogether, even purely for research purposes and even with tight ethical controls that will govern wholly private sector funded experiments.
One day we will have that debate. We will not have it today under the rules of this debate. As I will describe, those opposed to deriving additional stem cell lines through the somatic stem cell process also oppose using spare embryos as a source of additional stem cell lines and do so for the same basic argument.
The great topic of today's debate is whether it is ethical and proper for taxpayer funded scientists to use stem cells derived from embryos no longer needed in fertility treatment.
The process of in vitro fertilization consists of fertilizing a woman's egg in a laboratory and then placing the fertilized egg in a woman's womb so that gestation and childbirth can occur. This is what is done when couples have fertility problems. Although IVF procedures were very controversial when they were first developed and used back in 1983, over 200,000 Americans have been born through this technique that is widely accepted today.
Many had grave reservations about the IVF process when it was developed. Some of the fiercest opponents of IVF back then are also the most ardent opponents of S. 810. While I respect their views--and these are sincere and earnest individuals--I think they were wrong then and wrong now.
As part of the fertility treatment process, it is inevitable that there will be some test tube embryos that will not be needed and will never be implanted in a mother's womb. And let me be clear here, I believe that the highest and best use of a human embryo is to be used by loving parents to add to their family. I wholeheartedly support adoption of spare embryos and would give adoption precedence over use for research. I think most would agree with me on this.
But the fact of the matter today is that there may exist at any point in time more than 400,000 such unused embryos in the United States and each year tens of thousands of such spare embryos are routinely and un_cere_mon_iously discarded and destroyed. It is important to note that more than 11,000 of these embryos have already been used for research.
It is from these embryos that scientists have derived stem cell lines.
Here is how it works.
During the first few days of embryo development, whether in a mother's womb or in a Petri dish inside a fertility clinic, the fertilized egg--called a zygote--begins to divide and transform into a sphere of cells called a blastocyst. Depending on its stage of development, a blastocyst is comprised of about 30 to 150 cells. It is from the inner layer of the blastocyst that scientists can derive the unspecialized but pluripotent stem cells that hold so much promise.
As I said earlier, while there is some debate on this issue, the great bulk of the evidence and consensus view of leading experts is that, at this point in time, research on the embryonic stem cells holds at least as much, and probably a lot more, promise than research on adult stem cells and cord blood. That is because the experts believe that embryonic stem cells appear to be easier to identify and work with and appear to be more flexible than other sources of stem cells.
The sole purpose of H.R. 810 is to expand the number of stem cell lines eligible for Federal funding. If H.R. 810 passes and is signed into law, Americans will finally get the vigorous program of federally funded stem cell research complete with a rigorous system of Federal oversight of the ethical protections that the National Institutes of Health will place on this research.
The policy dispute that requires the legislative fix set forth in H.R. 810 revolves around the moral status of a spare embryo. Some, including President Bush and some in Congress, have reservations about using stem cells derived from embryos for research purposes. This concern is anchored in the perspective that human life begins at the moment of conception, be it in the womb or in the lab of a fertility clinic.
While I respect this view and those who hold it, I do not agree with it.
Let me say that I come into this debate as longtime, right-to-life Senator. I oppose abortion on demand. I think that Roe v. Wade was wrongly decided. I have worked to return the power to outlaw abortion from the courts to the states. In 1981, I proudly worked to report an anti-abortion constitutional amendment from the Senate Judiciary Committee.
In the 108th Congress, I served as chairman of the House-Senate Conference Committee that finalized long-overdue legislation to outlaw the barbaric practice of partial birth abortion. I was at the President's side when he signed this bill into law.
When it comes to a right-to-life philosophy, I do not take a back seat to anyone in this Chamber or the House of Representatives. I will put my pro-life track record up against anyone inside or outside of Congress.
When I considered the question of the moral status of stem cells created for, but no longer needed in, the in-vitro fertilization process, I did so from a long and fervently held pro-life philosophy.
I have discussed this issue with many experts in science and ethics on all sides of this issue. I spoke to many Utahns and other citizens about their views on this matter. I consulted books ranging from medical texts and the Bible.
I thought long and hard about this matter.
Sometimes, I simply prayed to God for guidance.
I take my pro-family, pro-life philosophy very seriously.
I believe the worth of each soul is absolute.
Accordingly, I reject any purely utilitarian argument that the promise of stem cell research is so great that the ends justify the means.
I do not think that research can ever justify the taking of even a single human life, no matter how frail or defenseless that person may be.
Let me just say that there is not a fairer or finer man in the U.S. Senate than my friend from Kansas, Senator Sam Brownback. As he has attempted to frame the issue:
The central question in this debate is simple: Is the embryo a person or a piece of property? If you believe ..... that life begins at conception and that the human embryo is a person fully deserving of dignity and the protection of our laws, then you have to believe that we must protect this innocent life from harm and protection.
After much thought, reflection, and prayer, I concluded that life begins in, and requires, a nurturing womb. Human life does not begin in a Petri dish.
I do not question that an embryo is a living cell.
But I do not believe that a frozen embryo in a fertility clinic freezer constitutes human life.
To my knowledge, as a matter of law, no member of the U.S. Supreme Court has ever taken the position in even a dissenting opinion, let alone a majority opinion, that fetuses, let alone embryos, are constitutionally protected persons.
I cannot imagine, for example, that many Americans would view an employee of a fertility clinic whose job it is to destroy unneeded embryos as a criminal--and a murderer at that. Yet this is a task that is performed thousands of times each and every year by hundreds of fertility clinic employees.
As well, the logical extension of Senator Brownback's life-begins-at-conception view might be to criminalize the actions of a woman or her doctor from using, or recommending the use of, some longstanding forms of contraception that impede fertilized eggs from attaching onto the uterine wall.
I simply do not believe that passing H.R. 810 and allowing federally funded researchers to use new stem cell lines derived from spare embryos from fertility clinics is somehow ethical.
It seems to me that you would have to believe that the in vitro fertilization process was unethical to begin with if you believe that it is unethical to use spare embryos that would never be used for fertility purposes and were slated for routine destruction.
I find both fertility treatment and embryonic stem cell research to be ethical.
I believe that being pro-life involves helping the living.
Regenerative medicine is pro-life and pro-family; it enhances, not diminishes human life.
My friend and colleague, Senator Gordon Smith, and I share a similar perspective on this important issue. Here is Senator Smith's eloquent response to the concerns raised by our friend, Senator Brownback:
..... when does life begin? Some say it is at conception. Others say it is at birth. For me in my quest to be responsible and to be as right as I know how to be, I turn to what I regard as sources of truth. I find this: ``And the Lord God formed man of the dust of the ground and breathed into his nostrils the breath of life, and man became a living soul.'' This allegory of creation describes a two-step process to life, one of the flesh, the other of the spirit ..... Cells, stem cells, adult cells, are, I believe, the dust of the earth. They are essential to life, but standing alone will never constitute life. A stem cell in a petri dish or frozen in a refrigerator will never, even in 100 years, become more than stem cells. They lack the breath of life. An ancient apostle once said: ``For the body without the spirit is dead.'' I believe that life begins in the mother's womb, not in a scientist's laboratory. Indeed, scientists tell me that nearly one-half of fertilized eggs never attach to a mother's womb, but naturally slough off. Surely, life is not being taken here by God or by anyone else.
I find much wisdom in Senator Smith's remarks and ask all of you to reflect upon his thoughtful and valuable perspective.
When the roll is called on H.R. 810, I will vote yea. I urge my colleagues to do likewise.
I applaud President Bush's decision to allow Federal funds to be used in connection with a limited number of stem cell lines that preexisted his August 9, 2001 speech. Frankly, I had hoped back in 2001 that President Bush would announce a more expansive policy.
Mr. President, I ask unanimous consent to have printed in the RECORD a letter I wrote to President Bush on this matter in June, 2001 on the issue of stem cell research as well as an accompanying letter to then Secretary of Health and Human Services, Tommy Thompson.
There being no objection, the material was ordered to be printed in the RECORD, as follows:
U.S. SENATE,
Washington, DC, June 13, 2001.
The President GEORGE WALKER BUSH,
The White House,
Washington, DC.
DEAR MR. PRESIDENT: I urge you to support federal funding of human pluripotent embryonic stem cell research. Upon substantial reflection, I find--and hope you will as well--that proceeding with this research is in the best interests of the American public and is consistent with our shared pro-life, pro-family values.
After carefully analyzing the factors involved, I conclude that, at this time, research on human pluripotent embryonic stem cells is legal, scientifically compelling, and ethically sound. I want to emphasize that my support for such research is contingent upon adherence to the applicable statutes, regulations and guidelines. For your information, I have provided a copy of my correspondence to Secretary Thompson that more fully explains my reasoning on this important matter.
Mr. President, one of the great legacies of your father's Presidency was the fall of the Berlin Wall which represented the victory of democracy in a 50-year battle with totalitarian regimes. Through sacrifice and love of country ``the Greatest Generation'' prevailed over both fascism and communism and proved more than equal to the challenges of the times. As a result, today the United States is in a unique position of leadership in the world. How America exerts this influence and invests our resources and energies will be observed closely by all of our global neighbors. It seems to me that leading the way in finding new cures for disease is precisely the type of activity that accrues to our benefit both at home and abroad.
In the opening days of your term in office, scientists have completed the task of sequencing the human genome. While this acccomplishment--the work of many in the public and private sectors--is of historical significance, it is only the end of the beginning in a new era of our understanding of the biological sciences, Over your next eight years in office, you have an unprecedented opportunity to provide the personal leadership required to see to it that your Administration will be remembered by future historians as the beginning of the end for such deadly and debilitating diseases as cancer, Alzheimer's, and diabetes.
To accomplish this, all promising and proper avenues of research must be explored. Throughout my career I have been proud to have worked with patients and families struggling with the daily realities of disabling high prevalence illnesses such as cancer, diabetes, and heart disease. As author of the Orphan Drug Act, I also am proud that over 200 drugs have been approved since this law was enacted in 1984 for such small population, but devastating diseases, as Hemophilia, Cystic Fibrosis, and ALS. In my 25 years of working to sustain and build America's formidable biomedical research enterprise, I have rarely, if ever, observed such genuine excitement for the prospects of future progress than is presented by embryonic stem cell research.
Mr. President, once you have considered the complexities of the questions at hand, I hope you will conclude, as other pro-life, pro-family Republicans such as Strom Thurmond, Gordon Smith, Connie Mack, and I, that the best course of action is to lead the way for this vital research.
Sincerely,
ORRIN G. HATCH,
United States Senator.
U.S. SENATE,
Washington, DC, June 13, 2001.
Hon. TOMMY G. THOMPSON,
Secretary of Health and Human Services,
Washington, DC.
DEAR MR. SECRETARY: I am writing to express my views regarding federal funding of biomedical research involving human pluripotent embryonic stem cells. After carefully considering the issues presented, I am persuaded that such research is legally permissible, scientifically promising, and ethically proper. Therefore, at this time, I support the use of federal funds to conduct research involving human pluripotent stem cells derived from embryos produced through the in vitro fertilization process. My support is, of course, conditioned upon such research being conducted in strict accordance with the relevant statutes and the protections set forth in the applicable regulations and guidelines, including those issued by the National Institutes of Health (NIH).
I am mindful that this is a matter over which reasonable, fair-minded persons may ultimately disagree. Despite this likely outcome, I believe it constructive for public dialogue to take place over this issue. For that reason, I recommend that you convene the National Institutes of Health Human Pluripotent Stem Cell Review Group (HPSCRG) or a similar expert advisory body to help bring resolution to this matter. The HPSCRG, to be chaired by Dr. James Kushner of the University of Utah, can become a key forum to provide information and advice for policymakers.
At the outset, let me be clear about one of my key perspectives as a legislator: I am pro-family and pro-life. I abhor abortion and strongly oppose this practice except in the limited cases of rape, incest, and to protect the life of the mother. While I respect those who hold a pro-choice view, I have always opposed any governmental sanctioning of a general abortion on demand policy. In my view, the adoption of the Hyde Amendment wisely restricts taxpayer financed abortions. Moreover, because of my deep reservations about the Supreme Court's decision in Roe v. Wade, I proposed--albeit unsuccessfully--an amendment to the Constitution in 1981 that would have granted to the states and Congress the power to restrict or even outright prohibit abortion.
In 1992, I led the Senate opposition to fetal tissue research that relied upon cells from induced abortions. I feared that such research would be used to justify abortion or lead to additional abortions. It was my understanding that tissue from spontaneous abortions and ectopic pregnancies could provide a sufficient and suitable supply of cells. Unfortunately, experts did not find these sources of cells as adequate for their research needs. Subsequently, the 1993 NIH reauthorization legislation changed the legal landscape on this issue.
Because of my strong pro-life beliefs, I am a co-sponsor of the Unborn Victims of Violence legislation that makes it a separate criminal offense to cause death of or bodily injury to unborn children. I also support the Child Custody Protection Act that addresses the problem of minors crossing state lines to obtain abortions in avoidance of home state parental consent or notification requirements. I have also helped lead the effort to outlaw partial birth abortion, a procedure I find to be particularly repugnant. I hope that the l07th Congress will succeed in adopting, and transmitting for the President's signature, legislation that will end late term abortions unless necessary to save the life of the mother.
I am proud of my strong pro-life, anti-abortion record. I commend the Bush Administration for its strong pro-life, pro-family philosophy. In my view research, on stem cells derived from embryos first created for, but ultimately not used in, the process of in vitro fertilization, raises questions and considerations fundamentally different from issues attendant to abortion. As I evaluate all these factors, I conclude that this research is consistent with bedrock pro-life, pro-family values. I note that our pro-life, pro-family Republican colleagues, Senators Strom Thurmond and Gordon Smith, as well as former Senator Connie Mack, support federal funding of embryonic stem cell research. It is my hope that once you have analyzed the issues, you will agree with us that this research should proceed.
THE LEGAL FRAMEWORK
After reviewing the relevant statutes and regulations, I conclude that there is no mandatory legal barrier under federal law to federal funding of research on human pluripotent embryonic stem cells. On January 15, 1999, the then-General Counsel of the Department of Health and Human Services, Harriet Raab, issued a legal opinion regarding federal funding for research involving human pluripotent stem cells. This opinion summarized the applicable law as follows:
``The statutory prohibition on the use of funds appropriated to HHS for human embryo research would not apply to research utilizing human pluripotent stem cells because such cells are not within the statutory definition. To the extent human pluripotent stem cells are considered human fetal tissue by law, they are subject to the statutory prohibition on sale for valuable consideration, the restrictions on fetal tissue transplantation research that is conducted or funded by HHS, as well as to the federal criminal prohibition on the directed donation of fetal tissue. Research involving human pluripotent stem cells excised from a non-living fetus may be conducted only in accordance with any applicable state or local law. Finally, the Presidential Directive banning federal funding of human cloning would apply to pluripotent stem cells, only if they were to be used for that purpose.''
While some take exception to this reading of the law, I believe that it sets forth a permissible interpretation of the current state of the law with respect to research on human pluripotent stem cells. I would also note that while subsequent to the issuance of the HHS Legal Opinion in January, 1999 attempts have been and are being made to change the law, Congress has not passed a bill that has altered the legal status quo. For example, Senator Brownback and others have attempted to change the law to prohibit flatly such research on fetal and embryonic stem cells. On the other hand, Senator Specter and others have supported legislation that would expand the range of permissible federally funded research activities to include derivation of pluripotent stem cells from totipotent stem cells. The considerable disagreement over what the law in this area should be stands in contrast to the common understanding of how the law has been interpreted by the Department.
It is worth noting that NIH has a carefully crafted network of regulations and guidelines that govern stem cell research. These guidelines, finalized in the Federal Register, on August 25, 2000 (65 FR 51976) were the subject of over 50,000 public comments. Among the key provisions of these requirements are:
NIH funds may only be used for research on human pluripotent stem cells derived from embryos, if such cells were derived from frozen embryos that were produced for the purpose of procreation but subsequently were not intended to be used for that purpose.
No financial or other inducements, including any promises of future remuneration from downstream commercialization activities, may be used to coerce the donation of the embryo.
A comprehensive informed consent must be obtained that includes recognition that the donated embryo will be used to derive human pluripotent stem cells for research that may include transplantation research; that derived cells may be stored and used for many years; that the research is not intended to provide direct medical benefit solely to a donor and that the donated embryo will not survive the derivation process; and, there must be a distinct separation between the fertility treatment and the decision to donate the embryos for research.
The donation may not be conditioned on any restrictions or directions regarding the individual who may receive the cells derived from the human pluripotent stem cells.
All recipients of NIH funds to conduct stem cell research must comply with guidelines and all laws and regulations governing institutional review boards.
NIH funds may not be used to: clone a human being; derive pluripotent stem cells from human embryos; conduct research using pluripotent stem cells derived from a human embryo created solely for research purposes; conduct research that creates or uses pluripotent stem cells derived from somatic cell nuclear transfer; or, combine human pluripotent stem cells with an animal embryo.
If there is a need to further strengthen the applicable guidelines and regulations, this should be done. But let us recognize that there already exists a thorough and thoughtful regulatory framework to build upon. It should also be noted that these guidelines build upon an extensive body of earlier work of the National Bioethics Advisory Committee, the Advisory Committee to the Director, NIH, and a special Human Embryo Research Panel convened by your predecessor. At this juncture, it appears that NIH is developing its stem cell research policies in an informed fashion within an area of its expertise, and is operating within a statutory environment such that, once finalized, the agency's actions will likely survive legal challenge due to the deference the courts grant these types of decisions.
THE SCIENTIFIC OPPORTUNITIES
Scientific experts believe that stem cells have tremendous potential in benefiting human health. Stem cells are thought to be a unique biological resource because these cells apparently have the potential to develop into most of the specialized cells and tissues of the body, including muscle cells, nerve cells, and blood cells. As the American Association for the Advancement of Science has characterized the promise of stem cell research: ``Research on these cells could result in treatments or cures for the millions of Americans suffering from many of humanity's most devastating illnesses, including Alzheimer's disease, diabetes, spinal cord injury, and heart disease.'' Potentially, stem cell research can help virtually every American family. It has been estimated that over 28 million Americans are afflicted with conditions that may benefit from embryonic stem cell research.
It is also worth noting in the pro-family context that stem cell research is of particular interest to pediatricians. Consider the views of Dr. Edward B. Clark, Chairman of the Department of Pediatrics, University of Utah School of Medicine:
``..... I can assure you that the scientific promise of stem cell research is extraordinary.
``In pediatrics, stem cell research offers therapy, and indeed possibly a cure, for a wide variety of childhood diseases, including neurologic disease, spinal cord injuries, and heart disease .....
``I can think of nothing that will provide as much meaningful therapy for children and children's problems than the promise offered by stem cell research.''
``We citizens of Utah are proud to be home of the Huntsman Cancer Institute at the University of Utah. The medical director of the Huntsman Cancer Institute, Dr. Stephen Prescott, advises me that in his expert opinion stem cells research `is an incredibly promising area that has potential application in many different fields of medicine. One of these is in the treatment of cancer, particularly as a way to control the side effects following standard treatments.' ''
I am also aware that some believe, including highly-respected scientists and many of my friends and colleagues in the Right to Life community, that adult stem cells actually hold greater promise than embryonic stem cells and that research on adult stem cells should be pursued to the exclusion of fetal or embryonic stem cells. It is my understanding that, at the present time, the view that adult stem cell research is sufficient or even scientifically preferable to embryonic stem cell research is not the predominant view within the biomedical research community.
While I have great admiration for, confidence in, and strongly support America's biomedical research enterprise, and I believe that our policy should be made on the best science available, I am hardly one who invariably follows the lead of what some may term ``the science establishment.'' With Senator Harkin, I authored the legislation that created the Center for Complementary and Alternative Medicine (CCAM) at NIH and believe there is great benefit in encouraging challenges to scientific orthodoxy. Similarly, I authored the Dietary Supplement Health and Education Act that set parameters on how the Food and Drug Administration may regulate dietary supplements as well as establishing the Office of Dietary Supplements (ODS) at NIH. To be sure, the creation of CCAM and ODS had their fair share of critics at NIH and among mainstream scientists. So be it.
In parallel to funding research on human pluripotent embryonic stem cells, I believe it is essential to carry out significant research on adult stem cells. I strongly urge the Administration to continue to provide sufficient resources to investigate fully the utility of adult stem cells as well cells derived from adipose tissue.
Policymakers should also consider another advantage of public funding of stem cell research as opposed to leaving this work beyond the reach of important federal controls. Federal funding will encourage adherence to all of the safeguards outlined above by entities conducting such research even when a particular research project is conducted solely with private dollars.
I also think it important to recognize explicitly that the knowledge gained through biomedical research can be harnessed for critical pro-life, pro-family purposes. When one of our loved ones is stricken by illness, the whole family shares in the suffering. The quality of life for America's families can improve as strides are made in biomedical research. This is why we are making good on the bipartisan commitment to double the funding of the NIH research program by 2003. I commend the Administration for its leadership in allocating resources for this worthy pro-life, pro-family purpose.
ETHICAL APPROPRIATENESS
While society must take into account the potential benefits of a given technological advance, neither scientific promise nor legal permissibility can ever be wholly sufficient to justify proceeding down a new path. In our pluralistic society, before the government commits taxpayer dollars or otherwise sanctions the pursuit of a field of research, it is imperative that we carefully examine the ethical dimensions before moving, or not moving, forward.
I would hope there is general agreement that modern techniques of in vitro fertilization are ethical and benefits society in profound ways. I have been blessed to be the father of six children and the grandfather of nineteen grandchildren. Let me just say that whatever success I have had as a legislator pales in comparison to the joy I have experienced from my family in my roles of husband, father, and grandfather. Through my church work, I have counseled several young couples who were having difficulty in conceiving children. I know that IVF clinics literally perform miracles every day. It is my understanding that in the United States over 100,000 children to date have been born through the efforts of IVF clinics.
Intrinsic with the current practice of IVF-aidcd pregnancies is the production of more embryos than will actually be implanted in hopeful mothers-to-be. The question arises as to whether these totipotent embryonic cells, now routinely and legally discarded-- amid, I might add, no great public clamor--should be permitted to be derived into pluripotent cells with non-federal funds and then be made available for research by federal or federally-supported scientists?
Cancer survivor and former Senator, Connie Mack, recently explained his perspective on the morality of stem cell research in a Washington Post op-ed piece:
``It is the stem cells from surplus IVF embryos, donated with the informed consent of couples, that could give researchers the chance to move embryonic stem cell research forward. I believe it would be wrong not to use them to potentially save the lives of people. I know that several members of Congress who consider themselves to be pro-life have also come to this conclusion.''
Senator Mack's views reflect those of many across our country and this perspective must be weighed before you decide.
Among those opposing this position is Senator Brownback, who has forcefully expressed his opinion:
``The central question in this debate is simple: Is the embryo a person, or a piece of property? If you believe that life begins at conception and that the human embryo is a person fully deserving of dignity and the protection of our laws, then you believe that we must protect this innocent life from harm and destruction.''
While I generally agree with my friend from Kansas on pro-life, pro-family issues, I disagree with him in this instance. First off, I must comment on the irony that stem cell research--which under Senator Brownback's construction threatens to become a charged issue in the abortion debate--is so closely linked to an activity, in vitro fertilization, that is inherently and unambiguously pro-life and pro-family.
I recognize and respect that some hold the view that human life begins when an egg is fertilized to produce an embryo, even if this occurs in vitro and the resulting embryo is frozen and never implanted in utero. To those with this perspective, embryonic stem cell research is, or amounts to, a form of abortion. Yet this view contrasts with statutes, such as Utah's, which require the implantation at a fertilized egg before an abortion can occur.
Query whether a frozen embryo stored in a refrigerator in a clinic is really equivalent to an embryo or fetus developing in a mother's womb? To me, a frozen embryo is more akin to a frozen unfertilized egg or frozen sperm than to a fetus naturally developing in the body of a mother. In the case of in vitro fertilization, extraordinary human action is required to initiate a successful pregnancy while in the case of an elective abortion an intentional human act is required to terminate pregnancy. These are polar opposites. The purpose of in vitro fertilization is to facilitate life while abortion denies life. Moreover, as Dr. Louis Guenin has argued: ``If we spurn [embryonic stem cell research] not one more baby is likely to be born.'' I find the practice of attempting to bring a child into the world through in vitro fertilization to be both ethical and laudable and distinguish between elective abortion and the discarding of frozen embryos no longer needed in the in vitro fertilization process.
In evaluating this issue, it is significant to point out that no member of the United States Supreme Court has ever taken the position that fetuses, let alone embryos, are constitutionally protected persons. To do so would be to thrust the courts and other governmental institutions into the midst of some of the most private of personal decisions. For example, the use of contraceptive devices that impede fertilized eggs from attaching onto the uterine wall could be considered a criminal act. Similarly, the routine act of discarding ``spare'' frozen embryos could be transformed into an act of murder.
As much as I oppose. partial birth abortion, I simply can not equate this offensive abortion practice with the act of disposing of a frozen embryo in the case where the embryo will never complete the journey toward birth. Nor, for example, can I imagine Congress or the courts somehow attempting to order every ``spare'' embryo through a full term pregnancy.
Mr. Secretary, I greatly appreciate your consideration of my views on this important subject. I only hope that when all relevant factors are weighed both you and President Bush will decide that the best course of action for America's families is to lead the way to a possible new era in medicine and health by ordering that this vital and appropriately regulated research proceed.
Sincerely,
Orrin G. Hatch,
United States Senator.
Mr. HATCH. Mr. President, although at one time it appeared that as many as 78 stem cell lines might qualify under the President's policy, as many had feared, the number of lines that might be practically accessed today is no more than around a dozen at best. Moreover, all of these cell lines were grown with so-called mouse feeder cells so could never pass muster with the FDA for use to make products for humans. Thus for the President's initial goals to be accomplished, new embryonic stem cell lines must be made available.
It has been over a year since he House has taken its historic action of passing H.R. 810 by a bipartisan 235-to-189 vote. I commend the leadership of Representatives Mike Castle and Diana DeGette for moving the bill through the House.
I must pay special respects to Senator Arlen Specter and Senator Tom Harkin for their dogged determination in conducting a series of some 15 oversight hearings on the issue of stem cell research since this breakthrough science was first reported in 1998. In fact, it was the work of the Specter-Harkin Labor-HHS Appropriations Subcommittee that developed the factual basis and legal analysis that resulted in the legislation that became H.R. 810.
At long last, today the Senate will finally vote on this important legislation.
I hope that it will pass and if it does, I will strenuously urge President to reconsider his position and sign this bill into law.
Mr. President, I yield the floor.
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