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I have been very moved by the many sick people and their relatives that have contacted me and told me that my legislation offers them hope. One of the most compelling stories is that of

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   In the face of the enormous promise of nuclear transplantation research, it is difficult to see why anyone wants to dash the hopes of Kris Gulden and the millions of others facing debilitating and painful illnesses and ailments. As former Senator Connie Mack has testified before the Senate:

   A cell isn't human life if it hasn't been fertilized by a sperm and placed in the womb'' and `[t]he research value of these cells is enormous. They have the potential to form any cell in the body and can reproduce indefinitely. Studies in animals demonstrate that this could lead to cures and treatments for millions of people.

   The legislation we introduce today would ban human reproductive cloning and preserve valuable medical research. I urge my colleagues to support this bill.

   I would also ask unanimous consent that several letters I have received supporting the Specter-Feinstein-Kennedy-Hatch approach to cloning be printed in the RECORD.

   There being no objection, the material was ordered to be printed in the RECORD, as follows:

   JOINT STEERING COMMITTEE

   FOR PUBLIC POLICY,

   Bethesda, MD, April 9, 2002.
Hon. ORRIN G. HATCH,
U.S. Senate, Hart Senate Office Building, Washington, DC.

   DEAR SENATOR HATCH: I am writing to seek your help with efforts being made by many disease advocacy groups and by many of us in the scientific community to protect highly valuable scientific research from an overzealous legislative proposal intended to prohibit the cloning of human beings.

   The measure in question, S. 1899, introduced by Senator Brownback and others, would, in effect, establish criminal penalties for three things: (i) attempts to produce a human being by methods that include transfer of a somatic cell nucleus (``nuclear transfer'') and placement of any resulting embryos into a uterus; (ii) the transfer of a human cell nucleus into an egg cell for any purposes; and (iii) the important of any products of nuclear transfer, including those used for medical treatment.

   No scientist of my acquaintance believes that it is currently appropriate or safe, even if it were feasible, to undertake the complex process intended to result in the birth of a cloned human being. For that reason, you are unlikely to hear objections to the first prohibition established by the Brownback bill, even from those who may question whether legislation and criminal penalties are useful instruments for preventing attempts at cloning that might be undertaken by irresponsible individuals.

   The second and third prohibitions, however, are deeply disturbing to many people, including those of use who have given considerable thought to the difficult ethical issues presented by these new technologies. The third prohibition is inappropriately punitive in the more obvious way: it could lead to punishment of seriously ill patients who have gone abroad to seek novel treatments that are unavailable in this country because they are based on nuclear transfer. But the second prohibition is troubling in a more profound way. For the first time in my experience, an American law would create criminal penalties for the use of a highly promising scientific method, regardless of the intent of the investigator, and would threaten to delay development of new therapies for common diseases.

   To appreciate our concerns, it is important to understand the nature of what is called ``nuclear transfer''. Recent studies with experimental animals show that a cell nucleus containing all, but expressing only some, of the genes of an organism can undergo extensive changes, or ``reprogramming'', when moved from one cell environment to another. This means that a nucleus from a highly specialized cell--for example, a skin call--can radically revise the set of genes that it uses when it is put into another cell, such as an egg cell, from which the pre-existing nucleus has been removed. In the new environment of the recipient cell, the genes in the nucleus appear to function as appropriate to that environment.

   Thus, when the recipient cell is an egg, the genes regain the ability to direct the progeny cells, which arise by division, to form nearly any of the many cell type that are found in a mature organism, if the cells are coaxed to do so by appropriate stimuli. This phenomenon has the potential to lead to great things a deeper understanding of human development, important insights into disease mechanism, and the abundant production of normal cells of virtually any type, which could then be used to treat a wide variety of diseases. Moreover, if a parent is the source of the transplanted, reprogrammed nucleus, the normal cells could be used to treat that individual without fear of immune rejection.

   Clearly we have a lot to learn before we can efficiently apply nuclear transfer and reprogramming to medical purposes--most obviously, we need to learn the best recipes to foster reprogramming and development into the various cell types. But studies with certain animal models of disease already show that these strategies can work, and the fundamental discoveries that have emerged from work with nuclear transfer offer legitimate hope for still greater discoveries in the future.

   Unfortunately, the opportunities make such discoveries and develop new therapies may well be denied to American scientists because of any inappropriate equation of the method used in reprogramming cells (nuclear transfer) and the goal of cloning whole organisms. This confusion is based in part on the use of nuclear transfer in an otherwise very different multi-step process that led ultimately to the birth of Dolly the sheep and other cloned animals. Indeed, S. 1899 considers transfer of a human somatic cell nucleus into an nucleated human egg for the purpose of reprogramming to be a punishable act of human cloning .

   It is crucial to emphasize how nuclear transfer, the reprogramming step, differs from attempts to generate a full-fledged organism. Absent transfer to a uterus, the cells that result from nuclear transfer into an egg cytoplasm will not form the complex and organized collection of cell types that characterize a developing organism. The initial aggregate of fewer than 200 cells, formed after introduction of a nucleus into an egg, lacks the recognizable types of cells that are needed to develop into the organs of a human being, and it is barely visible to the naked eye. Individual cells from this aggregate, however, can be used to develop stem cell lines, to study development of specialized cell types in a Petri dish, and to prepare materials for cell-based therapies.

   Furthermore, in the future, it is possible that cell reprogramming can be carried out in ways that do not involve the use of human egg cells or nuclear transfer itself. The chemicals in the cytoplasm of an egg cell that guide reprogramming have not yet been identified, but when they are it will be possible to use other cells and even simpler defined recipes to reprogram adult cells. Of course, these things will never happen, at least in this country, if the use of nuclear transfer to human eggs is outlawed.

   The Brownback bill that we are worried about today closely resembles a bill (S. 1601) proposed in 1998 by Senator Bond and others. At that time, you helped to derail the passage of that ill-considered measure with an insightful letter to one of the bill's sponsors and a speech on the Senate floor. Many of my colleagues and I believe that the concerns you raised then about the need to ``ban cloning of human beings but do so in a way that allows, to the extent ethically proper, valuable research to continue'' are still valid. For that reason, I hope you will join us in opposing S. 1899.

   Thank you for your consideration of my views on this important legislation. Needless to say, I am prepared to discuss any of the points I have made with you or your staff at any time.

   With best personal regards,
Harold Varmus,

   Chair, Joint Steering Committee
for Public Policy.

--

   CALIFORNIA INSTITUTE OF TECHNOLOGY,

   Pasadena, CA, April 8, 2002.
Senator ORRIN G. HATCH,
Hart Office Building,
Washington, DC.

   DEAR SENATOR HATCH: I am writing in opposition to the Brownback bill on cloning .

   I am a Nobel Laureate who has worked for 40 years in basic biological science and biotechnology. I have seen how a glimmer of an idea can grow to transform a technology, and I have great faith in the ability of basic science to create miraculous treatments for medical conditions.

   The use of nuclear transfer into the embryonic cells for reproductive purposes (so-called reproductive cloning ) is a technology that is a long way from being safe enough to be used to create human beings. So, issues of morality aside, I am totally opposed to using cloning technology for human reproduction. All of my colleagues with whom I have talked are equally opposed, but I am aware that there are people threatening to try to carry out the procedure. Thus, I support a legislative ban on reproductive cloning . I hope that any such ban will have a sunset clause so that in 5 years the question can be revisited.

   There is another use of somatic cell nuclear transfer into early embryonic cells

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   I am aware that there are bills in the Senate that would fit the requirements that I have set out. Senator Feinstein of my state along with Senator Kennedy has proposed such a bill as has Senators Specter and Harkin. They make the distinction between banning nuclear transfer for reproductive purposes and continuing to allow nuclear transfer for research and therapeutic purposes. These are bills that I can support.

   Sincerely yours,

   David Baltimore,
President.

--

   AMERICAN ASSOCIATION FOR THE

   ADVANCEMENT OF SCIENCE,

   Washington, DC, February 28, 2002.

   DEAR SENATOR: The Board of Directors of the American Association for the Advancement of Science (AAAS) recently adopted a policy statement on human cloning . I am enclosing a copy for your attention.

   Citing the serious risks associated with the procedure, the AAAS statement supports a legally enforceable ban on human reproductive cloning . At the same time, however, it backs stem cell research using cells derived with nuclear transplantation techniques, a procedure sometimes called therapeutic or research cloning . Such research offers enormous potential health benefits. However, because it also raises serious ethical, social, and religious concerns, it must be conducted under close scrutiny by the federal government.

   AAAS is the world's largest general scientific society with over 135,000 individual members and 275 affiliated societies representing all fields of science and engineering. Founded in 1848, it is also the publisher of Science magazine and has long been a leader in promoting ethical and responsible science.

   Sincerely,

   Alan I. Leshner,
Chief Executive Officer.

   Enclosure.

   AAAS Statement on Human Cloning

   The American Association for the Advancement of Science (AAAS) recognizes the intense debates within our society on the issue of human cloning . Since 1997, AAAS has engaged the public and various professional communities in dialogue on the scientific and social issues associated with human cloning and stem cell research. Those experiences form the backdrop for this statement on human cloning .

   BAN REPRODUCTIVE CLONING

   AAAS endorses a legally enforceable ban on efforts to implant a human cloned embryo for the purpose of reproduction. The scientific evidence documenting the serious health risks associated with reproductive cloning , as shown through animal studies, make it unconscionable to undertake this procedure. At the same time, we encourage continuing open and inclusive public dialogue, in which the scientific community is an active participant, on the scientific and ethical aspects of human cloning as our understanding of this technology advances.

   SUPPORT STEM CELL RESEARCH (INCLUDING ``RESEARCH CLONING'' )

   AAAS supports stem cell research, including the use of nuclear transplantation techniques (also known as research or therapeutic cloning ), in order to realize the enormous potential health benefits this technology offers. Such benefits are likely to be many years away. If they are to be realized at all, however, it will only be through carefully designed research subject to peer review. Because there are religious, ethical, and social concerns raised by the prospect of creating stem cells for research purposes, we believe that research cloning should only proceed under close scrutiny by the federal government over both the public and private sectors.

   EXERCISE APPROPRIATE OVERSIGHT

   A thorough assessment of existing guidelines and policy, including consideration of possible new regulations specific to this type of research, should be undertaken in light of the concerns surrounding it.

   Adopted by the AAAS Board of Directors, Boston, Massachusetts, February 14, 2002.

--

   THE AMERICAN SOCIETY

   OF HUMAN GENETICS,

   Bethesda, MD, February 5, 2002.
Hon. DIANNE FEINSTEIN,
U.S. Senate,
Washington, DC.

   DEAR SENATOR FEINSTEIN: The American Society of Human Genetics (ASHG) is a society of researchers and professionals in human genetics that represents nearly 8000 scientists, physicians, nurses, genetic counselors, and students actively engaged in genetic discovery, teaching, and application of knowledge of human genetics and the human genome.

   As a major scientific organization whose members have broad expertise and interest in matters related to human genetics, and in the application of genetic knowledge to the well being of people, the Society strives to be extremely thoughtful, thorough and ethical in pondering many of the scientific issues raised in public debate today. As stewards of the field of human genetics elected by the membership of the Society, the Board of Directors of ASHG affirms that basic research and the development of future applications of that research require the ongoing commitment to scientific integrity and social responsibility that has served our organization well for the last 50 years. In other words, scientists must proceed with commitment to rigorous critical evaluation and a heightened sense of responsibility to the patients who entrust their life and health to us.

   In concert with these principles, it is important for you and your colleagues to know that the ASHG concurs wholeheartedly with your bill ``The Human Cloning Prohibition Act'' that bans reproductive human cloning but is finely crafted so as not to prohibit new and evolving techniques that could potentially change the course of human illness as we know it today so that the collective quality of life is enhanced for all of us. Dr. Bert Vogelstein, in his testimony before the Labor Health and Human Services subcommittee on December 4, 2001, so eloquently captured the distinction surrounding two very different medical endeavors--regenerative medicine and the cloning of a human --the former being the potential key to the problem of immune rejection, the latter being morally and medically unacceptable.

   In closing, the Senate must be sure that any legislative action only bans cloning to create a human being and does no harm to legitimate biomedical research. Each Senate vote on proposed legislation must make this distinction clear or any ban would have profound negative impact on the advances that have been made thus far in this pioneering and exciting field.

   We congratulate you and your fellow senators for your insight and conviction to advancing the field of biomedical research.

   Sincerely yours,
Dr. P. Michael Conneally,

   ASHG President.
Dr. Joann A. Boughman,

   ASHG Executive Vice President.

--

   April 12, 2002.

   Closing Minds to Stem Cell Research

   The United States Senate is about to consider legislation that will determine the fate of a remarkable new form of medical research known colloquially as ``therapeutic cloning'' . The research could lead to unprecedented treatments for human disease, but has fallen prey to the confused debate over human stem cell research on the one hand, and the prospects of creating a cloned person on the other--two very different exercises that are now intricately entwined.

   The debate has its roots in the medical potential of human stem cells. All the tissues in our bodies arise from stem cells that are found in the early human embryo. Over the past several years, scientists have learned how to isolate and propagate human stem cells. There is hope that we will eventually be able to use these cells to more effectively treat cancer, diabetes, spinal cord injury, Alzheimer's and Parkinson's diseases, and others. This prospect has inspired great hope among individuals with ailments that had previously seemed incurable.

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