INTEREST GROUP 2: "CARE" DO NO HARM: THE COALITION OF AMERICANS FOR RESEARCH ETHICS "CARE" is a coalition organized expressly to oppose stem cell research. Among the readings below are included (1) the group's founding statement, and (2) a set of 12 lessons, or talking points that articulate the group's position on stem cell research. Your task is to craft a brief presentation that explains and justifies CARE's position on stem cell research and on the passage ofH.R. 810. You may frame your remarks as a presentation to the Senate to explain and justify CARE's position on this issue. READING ONE: CARE Founding Statement, July 1, 1999 Source: http://www.stemcell research.org/statement/statemenLhtm Accessed: 27 May 2006 Recent scientific advances in human stem cell research have brought into fresh focus the dignity and status of the human embryo. These advances have prompted a decision by the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) to fund stem cell research which is dependent upon the destruction of human embryos.l Moreover, the National Bioethics Advisory Commission (NBAC) is calling for a modification of the current ban against federally funded human embryo research in order to permit direct federal funding for the destructive harvesting of stem cells from human embryos.;;' These developments require that the legal, ethical, and scientific issues associated with this research be critically addressed and articulated. Our careful consideration of these issues leads to the conclusion that human stem cell research requiring the destruction of human embryos is objectionable on legal, ethical, and scientific grounds. Moreover, destruction of human embryonic life is unnecessary for medical progress, as alternative methods of obtaining human stem cells and of repairing and regenerating human tissue exist and continue to be developed.;l Human Embryonic Stem Cell Research Violates Existing Law & Policy In November 1998, two independent teams of U.S. scientists reported that they had succeeded in isolating and culturing stem cells obtained from human embryos and fetuses.1Stem cells are the cells from which all 210 different kinds of tissue in the human body originate.~ Because many diseases result from the death or dysfunction of a single cell type, scientists believe that the introduction of healthy cells of this type into a patient may restore lost or compromised function. Now that human embryonic stem cells can be isolated and multiplied in the laboratory, some scientists believe that treatments for a variety of diseases-such as diabetes, heart disease, Alzheimer's, and Parkinson's-may be within reach.§ While we in no way dispute the fact that the ability to treat or heal suffering persons is a great good, we also recognize that not all methods of achieving a desired good are morally or legally justifiable. If this were not so, the medically accepted and legally required practices of informed consent and of seeking to 2 do no harm to the patient could be ignored whenever some "greater good" seems achievable.-'Z One of the great hallmarks of American law has been its solicitous protection of the lives of individuals, especially the vulnerableJ~ Our nation's traditional protection of human life and human rights derives from an affirmation of the essential dignity of every human being.2 Our nation's traditional protection of human life and human rights derives from an affirmation of the essential dignity of every human being. Likewise, the international structure of human rights law-one of the great achievements of the modern world-is founded on the conviction that when the dignity of one human being is assaulted, all of us are threatened. The duty to protect human life is specifically reflected in the homicide laws of all 50 states. ill Furthermore, federal law and the laws of many states specifically protect vulnerable human embryos from harmful experimentation.11 Yet in recently publicized experiments, stem cells have been harvested from human embryos in ways which destroy the embryos.1~ Despite an existing congressional ban on federally-funded human embryo research,u the Department of Health and Human Services (HHS) determined on January 15, 1999 that the government may fund human embryonic stem cell research.11. The stated rationales behind this decision are that stem cells are not embryos (which itself may be a debatable point) and that research using cells obtained by destroying human embryos can be divorced from the destruction itself.1~-However, even NBAC denies this latter claim, as is evident by the following statement in its May 6, 1999 Draft Report on Stem Cell Research: Whereas researchers using fetal tissue are not responsible for the death of the fetus, researchers using stem cells derived from embryos will typically be implicated in the destruction of the embryo. This is true whether or not researchers participate in the derivation of embryonic stem cells. As long as embryos are destroyed as part of the research enterprise, researchers using embryonic stem cells (and those who fund them) will be complicit in the death of embryos.lfi If the flawed rationales ofHHS are accepted, federally-funded researchers may soon be able to experiment on stem cells obtained by destroying embryonic human beings, so long as the act of destruction does not itself receive federal funds.lLHowever, the very language of the existing ban prohibits the use of federal funds to support "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death ...."lIi Obviously, Congress' intent here was not merely to prohibit the use of federal funds for embryo destruction, but to prohibit the use of such funds for research dependent in any way upon such destruction. Therefore, the opinion of HHS that human embryonic stem cell research may receive federal funding clearly violates both the language of and intention behind the existing law. 19 Congress and the courts should ensure that the law is properly interpreted and enforced to ban federal funding for research which harms, destroys, or is dependent upon the destruction of human embryos. 3 It is important to recognize also that research involving human embryos outside the womb-such as embryos produced in the laboratory by in vitro fertilization (IVF) or cloning-has never received federal funding. Initially, this was because a federal regulation of 1975 prevented government funding ofIVF experiments unless such experiments were deemed acceptable by an Ethics Advisory Board?O Following the failure of the first advisory board to reach a consensus on the matter,?1 no administration chose to appoint a new board. After this regulation was rescinded by Congress in 1993,22 the Human Embryo Research Panel recommended to the National Institutes of Health (NIH) that certain kinds of harmful nontherapeutic experiments using human embryos receive federal funding?} However, these recommendations were rejected in part by President Clinton~ and then rejected in their entirety by Congress.~5 Further, it is instructive to note that the existing law which permits researchers to use fetal tissue obtained from elective abortions requires that the abortions are performed for reasons which are entirely unrelated to the research objectivesJf2 This law thus prohibits HHS from promoting the destruction of human life in the name of medical progress, yet medical progress is precisely the motivation and justification offered for the destruction of human life that occurs when stem cells are obtained from human embryos.ll Current law against funding research in which human embryos are harmed and destroyed reflects well-established national and international legal and ethical norms against the misuse of any human being for research purposes. Since 1975, those norms have been applied to unborn children at every stage of development in the womb, and since 1995 they have been applied to the human embryo outside the womb as well.28 The existing law on human embryonic research is a reflection of universally accepted principles governing experiments on human subjects-principles reflected in the Nuremberg Code, the World Medical Association's Declaration of Helsinki, the United Nations Declaration of Human Rights, and many other statements. Accordingly, members of the human species who cannot give informed consent for research should not be the subjects of an experiment unless they personally may benefit from it or the experiment carries no significant risk of harming them. Only by upholding such research principles do we prevent treating people as things-as mere means to obtaining knowledge or benefits for others. It may strike some as surprising that legal protection of embryonic human beings can co-exist with the U.S. Supreme Court's 1973 legalization of abortion.29 However, the Supreme Court has never prevented the government from protecting prenatal life outside the abortion context, 30 and public sentiment also seems even more opposed to government funding of embryo experimentation than to the funding of abortion.1J The laws of a number of states-including Louisiana, Maine, Massachusetts, Michigan, Minnesota, Pennsylvania, Rhode Island, and Utah-specifically protect embryonic human beings outside the womb. Most of these provisions prohibit experiments on embryos outside the womb.J~ We believe that the above legally acknowledged protections against assaults on human dignity must be extended to all human beingsirrespective of gender, race, religion, health, disability, or age. Consequently, the human embryo must not be subject to willful destruction even if the stated motivation 4 is to help others. Therefore, on existing legal grounds alone, research using stem cells derived from the destruction of early human embryos is proscribed. Human Embryonic Stem Cell Research Is Unethical The HHS decision and the recommendations ofNBAC to federally fund research involving the destruction of human embryos would be profoundly disturbing even if this research could result in great scientific and medical gain. The prospect of government-sponsored experiments to manipulate and destroy human embryos should make us all lie awake at night. That some individuals would be destroyed in the name of medical science constitutes a threat to us all. Recent statements claiming that human embryonic stem cell research is too promising to be slowed or prohibited underscore the sort of utopianism and hubris that could blind us to the truth of what we are doing and the harm we could cause to ourselves and others. Human embryos are not mere biological tissues or clusters of cells; they are the tiniest of human beings.33 Thus, we have a moral responsibility not to deliberately harm them. An international scientific consensus now recognizes that human embryos are biologically human beings beginning at fertilization, and acknowledges the physical continuity of human growth and development from the one-cell stage forward. 34 In the 1970s and 1980s, some frog and mouse embryologists referred to the human embryo in its first week or two of development as a "pre-embryo," claiming that it deserved less respect than embryos in later stages of development.35 However, some embryology textbooks now openly refer to the term "pre-embryo" as a scientifically invalid and "inaccurate" term which has been "discarded" and others which once used the term have quietly dropped it from new editions16 . Both the Human Embryo Research Panel31 and the National Bioethics Advisory Commission38 have also rejected the term, describing the human embryo from its earliest stages as a living organism and a "developing form of human life.,,12 The claim that an early human embryo becomes a human being only after 14 days or implantation in the womb is therefore a scientific myth. Finally, the historic and well-respected 1995 Ramsey Colloquium statement on embryo research acknowledges that: The [embryo] is human; it will not articulate itself into some other kind of animal. Any being that is human is a human being. If it is objected that, at five days or fifteen days, the embryo does not look like a human being, it must be pointed out that this is precisely what a human being looks like-and what each of us looked like-at five or fifteen days of development.±Q Therefore, the term "pre-embryo," and all that it implies, is scientifically invalid. The last century and a half has been marred by numerous atrocities against vulnerable human beings in the name of progress and medical benefit. In the 19th century, vulnerable human beings were bought and sold in the town square as slaves and bred as though they were animals.ll In this century, the vulnerable were executed mercilessly and subjected to demeaning experimentation at Dachau and Auschwitz.42 At midcentury, the vulnerable were subjects of our own government's radiation experiments 5 without their knowledge or consent.43 Likewise, vulnerable African-Americans in Tuskegee, Alabama were victimized as subjects of a government-sponsored research project to study the effects of syphilis.'I1 Currently, we are witness to the gross abuse of mental patients used as subjects in purely experimental research.45 These experiments were and are driven by a crass utilitarian ethos which results in the creation of a "subclass" of human beings, allowing the rights of the few to be sacrificed for the sake of potential benefit to the many. These unspeakably cruel and inherently wrong acts against human beings have resulted in the enactment of laws and policies which require the protection of human rights and liberties, including the right to be protected from the tyranny of the quest for scientific progress. The painful lessons of the past should have taught us that human beings must not be conscripted for research without their permission-no matter what the alleged justification--especially when that research means the forfeiture of their health or lives. Even if an individual's death is believed to be otherwise imminent, we still do not have a license to engage in lethal experimentation-just as we may not experiment on death row prisoners or harvest their organs without their consent. We are aware that a number of Nobel scientists endorse human embryonic stem cell research on the basis that it may offer a great good to those who are suffering.46 While we acknowledge that the desire to heal people is certainly a laudable goal and understand that many have invested their lives in realizing this goal, we also recognize that we are simply not free to pursue good ends via unethical means. Of all human beings, embryos are the most defenseless against abuse. A policy promoting the use and destruction of human embryos would repeat the failures of the past. The intentional destruction of some human beings for the alleged good of other human beings is wrong. Therefore, on ethical grounds alone, research using stem cells obtained by destroying human embryos is ethically proscribed. Human Embryonic Stem Cell Research Is Scientifically Questionable Integral to the decision to use federal funds for research on human embryonic stem cells is the distinction between stem cells and embryos. HHS has stated that federal funds may be used to support human embryonic stem cell research because stem cells are not embryos. A statement issued by the Office of the General Counsel of HHS regarding this decision asserts that "The statutory prohibition on the use of [government] funds ...for human embryo research would not apply to research utilizing human pluripotent stem cells because such cells are not a human embryo within the statutory definition. [Moreover, because] pluripotent stem cells do not have the capacity to develop into a human being, [they] cannot be considered human embryos consistent with the commonly accepted or scientific understanding of that term.,,11 It is important to note that the materials used in an experiment, as well as the methods of experimentation, are considered to be part of scientific research. When a scientific study is published, the first part of the article details the methods and materials used to conduct the research. Ethical and scientific evaluation of an experiment takes into account both the methods and materials used in the research process. Therefore, the 6 source of stem cells obtained for research is both a scientifically and ethically relevant consideration. Research on human embryonic stem cells is objectionable due to the fact that such research necessitates the prior destruction of human embryos;:lli however, the HHS's claim that stem cells are not, and cannot develop into, embryos may itself be subject to dispute. Some evidence suggests that stem cells cultured in the laboratory may have a tendency to recongregate and form an aggregate of cells capable of beginning to develop as an embryo. In 1993, Canadian scientists reported that they successfully produced a live-born mouse from a cluster of mouse stem cells. While it is true that these stem cells had to be wrapped in placenta-like cells in order to implant in a female mouse, it seems that at least some doubt has been cast on the claim that a cluster of stem cells is not embryonic in nature.'!.2If embryonic stem cells do indeed possess the ability to form or develop as a human embryo (without any process of activation which affects the transformation of the cell into a human embryo), research on such stem cells could itself involve the creation and/or destruction of human life and would thereby certainly fall under the existing ban on federally-funded embryo research. It would be irresponsible for the HHS to conduct and condone human embryonic stem cell research without first discerning the status of these cells. Their use in any research in which they could be converted into human embryos should likewise be banned. Methods of Repairing and Regenerating Human Tissue Exist Which Do Not Require the Destruction of Human Embryos While proponents of human embryonic stem cell research lobby aggressively for government funding of research requiring the destruction of human embryos, alternative methods for repairing and regenerating human tissue render such an approach unnecessary for medical progress. For instance, a promising source of more mature stem cells for the treatment of disease is hematopoietic (blood cell-producing) stem cells from bone marrow or even from the placenta or umbilical cord blood in live births. These cells are already widely used in cancer treatment and in research on treating leukemia and other diseases. 50 Recent experiments have indicated that their versatility is even greater than once thought. For example, given the right environment, bone marrow cells can be used to regenerate muscle tissue, opening up a whole new avenue of potential therapies for muscular dystrophies. 51 In April 1999, new advances were announced in isolating mesenchymal cells from bone marrow and directing them to form fat, cartilage, and bone tissue.g Experts in stem cell research believe that these cells may allow for tissue replacement in patients suffering from cancer, osteoporosis, dental disease, or injury.l~ An enormously promising new source of more mature stem cells is fetal bone marrow, a source which is many times more effective than adult bone marrow and umbilical cord blood. 54 It appears that fetal bone marrow cells do not provoke immune reactions to the same degree as adult or even newborn infant cells. This is true whether the unborn child is the donor or the recipient-that is, fetal cells can be used to treat adults, or adult bone marrow cells can be used to treat a child in the womb without the usual risk of harmful immune reactions.55 Such cells would not need to be derived from 7 fetuses who were intentionally aborted, but could instead be obtained from spontaneously aborted fetuses or stillborn infants. 56 In 1999, unprecedented advances were also made in isolating and culturing neural stem cells from living human nerve tissue and even from adult cadavers. Such advances render it quite possible that treatment of neural diseases such as Parkinson's and Alzheimer's, as well as spinal cord injuries, will not depend upon destructive embryo research. 'j} Earlier claims that embryonic stem cells are uniquely capable of "self-renewal" and indefinite growth can also now be seen as premature. For example, scientists have isolated an enzyme, telomerase, which may allow human tissues to grow almost indefinitely. Although this enzyme has been linked to the development of cancer, researchers have been able to use it in a controlled way to "immortalize" useful tissue without producing cancerous growths or other harmful side effects. Thus, cultures of non-embryonic stem cells may be induced to grow and develop almost indefinitely for clinical use.i8. One of the most exciting new advances in stem cell research is the January 1999 announcement that Canadian and Italian researchers succeeded in producing new blood cells from neural stem cells taken from an adult mouse.59 Until recently, it was believed that adult stem cells were capable of producing only a particular type of cell: for example, a neural stem cell could develop only into cells belonging to the nervous system. Researchers believed that only embryonic stem cells retained the capacity to form all kinds of tissue in the human body. However, if stem cells taken from adult patients can produce cells and tissues capable of functioning within entirely different systems, new brain tissue needed to treat a patient with Parkinson's disease, for example, might be generated from blood stem cells derived from the patient's bone marrow. Conversely, neural stem cells might be used to produce needed blood and bone marrow. Use of a patient's own stem cells would circumvent one of the major obstacles posed by the use of embryonic stem cells-namely, the danger that tissue taken from another individual would be rejected when transplanted into a patient.6o Thus, in commenting on this finding, the British Medical Journal remarked on January 30, 1999 that the use of embryonic stem cells "may soon be eclipsed by the more readily available and less controversial adult stem cells.,,§J Given that the function of the adult stem cells was converted without the cells first having to pass through an embryonic stage, the use of such cells would not be subject to the ethical and legal objections raised by the use of human embryonic stem cells.t2:2. The Director of the NIH has pointed out that evidence that adult stem cells can take on different functions has emerged only from studies on mice. However, his own claim that human embryonic stem cell research can produce treatments for diabetes and other diseases is also based solely on experimental success in mice. One approach to tissue regeneration that does not rely on stem cells at all, but on somatic cell gene therapy, is already in use as an experimental treatment. A gene that 8 controls production of growth factors can be injected directly into a patient's own cells, with the result that new blood vessels will develop. In early trials, this type of therapy saved the legs of patients who would have otherwise undergone amputation.9,l It was reported in January 1999 that the technique has generated new blood vessels in the human heart and improved the condition of 19 out of 20 patients with blocked cardiac blood vessels,!'-1 Such growth factors are now being explored as a means for growing new organs and tissues of many kinds. The above recent advances suggest that it is not even necessary to obtain stem cells by destroying human embryos in order to treat disease. A growing number of researchers believe that adult stem cells may soon be used to develop treatments for afflictions such as cancer, immune disorders, orthopedic injuries, congestive heart failure, and degenerative diseases. Such researchers are working to further research on adult, rather than embryonic, stem cells.9i In light of these promising new scientific advances, we urge Congress to provide federal funding for the development of methods to repair and regenerate human tissue which do not require the destruction of embryonic human life. However, even if such methods do not prove to be as valuable in treating disease as are human embryonic stem cells, use of the latter in the name of medical progress is still neither legally nor ethically justifiable for the reasons stated in this document. Conclusion We believe that an examination of the legal, ethical, and scientific issues associated with human embryonic stem cell research leads to the conclusion that the use of federal funds to support any such research that necessitates the destruction of human embryos is, and should remain, prohibited by law. Therefore, we call on Congress to (1) maintain the existing ban against harmful federally-funded human embryo research and make explicit its application to stem cell research requiring the destruction of human embryos and (2) provide federal funding for the development of alternative treatments which do not require the destruction of human embryonic life. If anything is to be gained from the cruel atrocities committed against human beings in the last century and a half, it is the lesson that the utilitarian devaluation of one group of human beings for the alleged benefit of others is a price we simply cannot afford to pay. (REFERENCES OMITTED) 9 CARE READING 2: TWELVE LESSONS ABOUT STEM CELL RESEARCH: http://www.stcmcellrcsearch.org/polisci/index.htmIAccessed: 27 May 2006 Congress is considering legislation to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype often substitutes for the scientific facts. This series of one-page "lessons" responds to mere politics with science. - Lesson 1: The Fountain of Youth Do embryonic stem cells produce a fountain of youth, or an eruption of cancer? - Lesson 2: Remember Not to 'I'ell Fairy Tales About Alzheimer's: Scientific experts agree that claims of an embryonic stem cell cure for Alzheimer's disease are far-fetched. -Lesson 3: Pay Attention To Your Own Scientists' Results If Christopher Reeve had read his own researchers' results, he would have known that the unique promise of embryonic stem cells has been exaggerated. - Lesson 4: 'rhe Myth of the 400,000 Embryos: Embryos currently frozen in fertility clinics offer nothing like the inexhaustible supply of stem cells some claim. - Lesson 5: Juvenile Comments About Diabetes: Embryos currently frozen in fertility clinics offer nothing like the inexhaustible supply of stem cells some claim. - Lesson 6: The Hard Sell on Cell Lines: The stem cell lines eligible for funding under President Bush's policy are not as limited, and new privately created lines are not as superior, as some assume. - Lesson 7: It's Not Political Hype That Will Get People Walking Again: It's adult stem cell research that is beginning to get spinal cord injury patients out of their wheelchairs. - Lesson 8: Bloody Nonsense: Do umbilical cord blood stem cells treat only blood diseases? Not by a long shot. - Lesson 9: Making a Difference? Getting stem cells to make many different cell types in the lab, and getting them to make real treatments for people, are very different things. - Lesson 10: You Can't Advance Science By Denying Science: Denying that human embryos are human beings isn't just immoral. It's unscientific. - Lesson 11: Not Months or Days. But Decades: Although the public is often promised miracle cures, it could be decades before embryonic stem cells can be used to treat any disease. - Lesson 12: Don't 'I'hrow Away the Future: Umbilical cord blood stem cells can now help suffering patients with six dozen illnesses, and show promise in treating many more. Due to a lack of national coordination and funds for cord blood banking, 4 million samples of cord blood are discarded in hospital nurseries every year - a tragedy that Washington-area Channel 4 News calls "throwing away the future." [12 Lessons: In attached PDF files] "As to diseases ,make a habit of two thingsto help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 1: THE FOUNTAIN OF YOUTH DO NO HARM Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of Congress distinguish mere politics from science. POLITICAL: 1b8 Coaltion of Alluo:ans fur Resslltb Etfta FOUNDING "If scientists are correct, stem cell research could result in a veritable fountain of youth by replacing diseased or damaged cells." MEMBERS Kevin Fitzgerald, SJ., Ph.D. Doctor LiJuler Professor for Catholic Health Care Ethics; Assodate Professor of Oncology, Georgetown University C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Qinic (MN); Chair, Mayo Clinical Ethics Coundl, Mayo Reproductive Medidne Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. AssOCiate Professor (Emertlus) of PfJarmocology Brown University School of Medidne Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medidne - Senator Arlen Specter of Pennsylvania, Congressional Record, March 16, 2005, p. S2764 SCIENCE: "The emerging truth in the lab is that pluripotent stem cells are hard to rein in. The potential that they would explode into a cancerous mass after a stem cell transplant might turn out to be the Pandora's box of stem cell research." - Ethicist Glenn McGee of University of Pennsylvania, quoted in E. Jonietz, "Innovation: Sourcing Stem Cells," Technology Review, JanuaryfFebruary 2001, p. 32 Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Ufe Sdences Family Research Council Center for Clinical 810ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medidne and Dentistry, University of Rochester; Director, Refonned Theological Seminary, Metro Washington Joseph Zanga, M.D. Chairman, DepartmentofPed~trlcs Loyola University Medical Center 1100 H Street, NW Suite 700 Washington, DC 20004 PH: 202347-6840 Fax: 202347-6849 www.stemcellresearch.org It is Dr. McGee's concern that is being borne out by the science. Tulane University research professor Brian Butcher says: "We're not against stem-cell research of any kind. But we think there are advantages to using adult stem cells. For example, with embryonic stem cells, a significant number become cancer cells, so the cure could be worse than the disease." See Heather Heilman, "Great Transformations," The Tulanian, Spring 2004, at www2:tulane.edularticle news details.cfm? ArticleID=5155. That fountain of youth seems less appealing when it might become a cancerous eruption of many cell types at once in a patient's body. The political hype about embryonic stem cells is ignoring real dangers to patients. / For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. 5/9/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- LESSON DO NO HARM 2: THE "POLITICAL SCIENCE" OF STEM CELLS REMEMBER NOT TO TELL FAIRY TALES ABOUT ALZHEIMER'S Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of Congress distinguish mere politics from science. POLITICAL: The Coalition of Americans for Research FOUNDING Ethics MEMBERS "This issue is especially poignant given President Reagan's passing. Embryonic stem cell research might hold the key to a cure for Alzheimer's and other terrible diseases. " Kevin Fitzgerald, 5.J., Ph.D. Research Associate, Division of Hematology and Oncology Loyola University Medical Center - News release from Sen. Dianne Feinstein, June 7, 2004, http:// feinstein. senate. gov /04 Releases/r -stemcell-l tr .htm C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Chairman, Department of Pediatrics Loyola University Medical Center 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org SCIENCE: "[T]he infrequently voiced reality, stem cell experts confess, is that, of all the diseases that may someday be cured by embryonic stem cell treatments, Alzheimer's is among the least likely to benefit. ... "[G]iven the lack of any serious suggestion that stem cells themselves have practical potential to treat Alzheimer's, the Reagan-inspired tidal wave of enthusiasm stands as an example of how easily a modest line of scientific inquiry can grow in the public mind to mythological proportions. "It is a distortion that some admit is not being aggressively corrected by scientists. "'To start with, people need a fairy tale,' said Ronald D.G. McKay, a stem cell researcher at the National Institute of Neurological Disorders and Stroke. 'Maybe that's unfair, but they need a story line that's relatively simple to understand.'" - Rick Weiss, "Stem Cells An Unlikely Therapy for Alzheimer's," ton Post, June 10, 2004, p. A3 The Washing- In light of the scientific realities, a central claim in the campaign for embryonic stem cell research seems to be myth, fairy tales and distortion. Don't patients deserve better? For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. -###5/11/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 3: PAY ATTENTION TO YOUR OWN SCIENTISTS' RESULTS DO NO HARM The Coalition of Americans for Research FOUNDING Ethics MEMBERS Kevin Fitzgerald, S.J., Ph.D. Research Associate, Division of Hematology and Oncology Loyola University Medical Center Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos, In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of Congress distinguish mere politics from science, POLITICAL: [Explaining why adult and umbilical cord blood stem cells are inferior to embryonic stem cells:] "[T]hose are cells that have significantly differentiated; that is, they are no longer pluripotent or capable of transforming into other cell types. For the true biological miracles that researchers have only begun to foresee, medical science must turn to undifferentiated stem cells," C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee - Christopher Reeve, testifying to Congress on behalf of the Christopher Reeve Paralysis Foundation, April 26, 2000, www.chrisreevehomepage.com/ testimony-nih.html (emphasis added). Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. SCIENCE: "Pluripotent stem cells have been detected in multiple tissues in the adult, participating in normal replacement and repair, while undergoing selfrenewal. " Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington - First sentence of a scientific study funded by the Christopher Reeve Paralysis Foundation, submitted for publication March 31, 2000 (emphasis added). The authors cite 11 earlier studies in support of this statement, and conclude that mesenchymal stem cells from adult bone marrow would have significant advantages over embryonic stem cells in treating a variety of neurologic diseases. See D. Woodbury et aI., "Adult Rat and Human Bone Marrow Stromal Cells Differentiate Into Neurons," 61 J. of Neuroscience Research 364-70 (2000). Chairman, Department of Pediatrics Loyola University Medical Center Since 2000, at least seven more major studies have demonstrated the amazing versatility of adult stem cells. For citations see PowerPoint presentation by David A. Prentice, Ph.D., "Cloning and Stem Cell Research," www.stemcellresearch.org/testimony/prentice_2005-0 1-03 .pdf, p. 20. 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. Joseph Zanga, M.D. -###- "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 4: THE MYTH OF THE 400,000 EMBRYOS DO NO HARM The Coalition of Americans for Research FOUNDING Ethics MEMBERS Kevin Fitzgerald, S.J., Ph.D. Research Associate, Division of Hematology and Oncology Loyola University Medical Center Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of Congress distinguish mere politics from science. POLITICAL: "There are estimated to be more than 400,000 IVF embryos, which are currently frozen and will likely be destroyed if not donated, with informed consent of the couple, for research." - Letter from over 200 House members to President Bush, April 28, 2004, at www.house.gov/shays/news/2004/april/aprstem.htm SCIENCE: C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Chairman, Department of Pediatrics Loyola University Medical Center 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org From the research study that provided the estimate of 400,000 frozen embryos in the U.S.: "Patients have designated only 2.8 percent (about 11,000 embryos) for research. The vast majority of frozen embryos are designated for future attempts at pregnancy. "From those embryos designated for research, perhaps as many as 275 stem cell lines (cell cultures suitable for further development) could be created. The actual number is likely to be much lower." - The RAND Law and Health Initiative, "How Many Frozen Human Embryos Are Available for Research?" (2003), at www.rand.org/publications/RB/RB9038/ In short, over 200 House members based their support for the expanded destruction of human embryos on a factual claim that is 97% false. The frozen embryos potentially available for research are enough for current laboratory research and animal trials - but then, so are the cell samples available under the Bush policy (many of which have not been turned into ongoing cell lines because they are not yet needed). Treatment of any major human disease, however, would require projects in human cloning, or the creation and destruction of vast numbers of new embryos carefully chosen to match the genetic diversity of the population. The myth of the 400,000 embryos is used to mask the fact that the campaign for "spare" embryos is useless in and of itself, and is only a transitional step to a broader agenda. For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. -###5/16/05 "As to diseases ,make a habit of two thingsto help, or at least do no harm." - Hippocrates. The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 5: JUVENILE COMMENTS ABOUT DIABETES DO NO HARM The Coali~on of Americans for Research Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of Congress distinguish mere politics from science. POLITICAL: "Stem cell research offers the greatest potential for curing ... diabetes." Ethics - Rep. Mark Kirk (R-IL) at a rally for embryonic stem cell research, UPI, May 16, 2005. FOUNDING MEMBERS SCIENCE: Kevin Fitzgerald, S.J., Ph.D. Research Associate, Division of Hematology and Oncology Loyola University Medical Center "Is the use of embryonic stem cells close to being used to provide a supply of islet cells for transplantation into humans?" C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Chairman, Department of Pediatrics Loyola University Medical Center 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org "No. The field of embryonic stem cells faces enormous hurdles to overcome before these cells can be used in humans. The two key challenges to overcome are making the stem cells differentiate into specific viable cells consistently, and controlling against unchecked cell division once transplanted. Solid data of stable, functioning islet cells from embryonic stem cells in animals has not been seen." - Autoimmune Disease Research Foundation, "Q & A," at www.cureautoimmunity.org/Q%20&%20A%20v2.htm (accessed May 16,2005) Despite years of effort and substantial funding from the Juvenile Diabetes Research Foundation, Harvard researcher Douglas Melton admits that he and others have failed to get embryonic stem cells to create insulin-producing beta cells that can reverse diabetes. "We are convinced we can do it," he says. "We just don't know how" (The Wall Street Journal, August 12,2004, p. AI). Meanwhile, hundreds of patients with juvenile diabetes have benefited from adult islet cell transplants from cadavers, with many now able to throwaway their insulin needles (Id.). The first successful islet cell transplant from a living donor was recently announced (The Lancet, published online April 19, 2005). By converting adult liver cells into insulin-secreting cells, an Israeli group has shown that diabetic patients may be able to serve as their own donors (proceedings of the National Academy of Sciences, published online May 17, 2005). And a new approach using adult spleen cells, pioneered by Harvard researchers, has achieved permanent reversal of diabetes in hundreds of animals and been approved by the FDA for human trials (The N.Y Times, November 9,2004). These avenues now show greater promise for treatments than embryonic stem cells. For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. -###5/18/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 6: THE HARD SELL ON CELL LINES DO NO HARM The Coali~on of Americans for Research FOUNDING Ethics MEMBERS Kevin Fitzgerald, S.J., Ph.D. Research Associate, Division of Hematology and Oncology Loyola University Medical Center C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Chairman, DepartmentofPed~trics Loyola University Medical Center 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding. political hype has often substituted for the scientific facts. This series will help members of Congress distinguish mere politics from science. POLITICAL: "When Bush announced his Executive Order limiting federal funding to studies on existing stem-cell lines, he declared that private research had produced more than 60 genetically diverse lines that would be eligible. Researchers now say the number is more like 22, and even those are contaminated with mouse DNA, making them ill-suited for use on humans." - "Why Bush's Ban Could Be Reversed," CNN.com, May 16,2005 SCIENCE: This confusion is based on a failure to understand the difference between a cell sample derived from an embryo, and the ongoing cell line that may be developed over time from that sample. The Bush policy allows federally funded research on cell lines developed after August 9, 2001, as long as the original cells were derived from an embryo by that date. Several dozen cell samples remain potentially eligible for federally funded research; the number now available in the form of self-perpetuating cell lines is 22 and growing. Many other samples, now in frozen storage, are available for future use if the currently active cell lines deteriorate or become inadequate for basic research. And many of these "cell lines not yet available for shipping" (the 16 samples now in storage at G6teborg University, for example) were isolated without animal feeder cells, and could be cultured on human cell layers now that this technique has been developed (see http://stemcells.nih.gov/research/registry/PDFs/ UnavailableLines. pdt). Ironically, the charges launched against the Bush administration's cell lines by its critics are far more true of the new cell lines those critics insist should receive federal funding. For example, the cell lines created at Harvard last year with private funding from the Juvenile Diabetes Research Foundation soon developed serious genetic abnormalities -- because they were not kept in frozen storage until needed, but were immediately induced to start growing and mutating. C. Cowan et aI., "Derivation of Embryonic Stem-Cell Lines from Human Blastocysts," 350 New England Journal of Medicine (2004): 1353-6 at 1355. Recent research suggests that all actively developing human embryonic stem cell lines may spontaneously accumulate genetic abnormalities associated with cancer: J. Draper et aI., "Recurrent gain of chromosomes 17q and 12 in cultured human embryonic stem cells," 22 Nature Biotechnology (2003): 53-4. And all of Harvard's new cell lines are "contaminated" with mouse feeder cells. Cowan, p. 1353. For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. -###5/20/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON DO NO HARM The Coalition of Americans for Research FOUNDING Ethics MEMBERS Kevin Fitzgerald, S.J., Ph.D. Research Associate, Division of Hematology and Oncology Loyola University Medical Center C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmacology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine 7: IT'S NOT POLITICAL HYPE THAT WILL GET PEOPLE WALKING AGAIN Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of Congress distinguish mere politics from science. POLITICAL: "If we do the work that we can do in this country, the work that we will do when John Kerry is president, people like Christopher Reeve are going to walk, get up out of that wheelchair and walk again." - Sen. John Edwards, vice-presidential candidate, on embryonic stem cells, October 11, 2004 SCIENCE: "It appears though. at the moment, that embryonic stem cel1s are effective in treating acute injuries and are not able to do much about chronic injuries." - Christopher Reeve, chronic spinal cord injury patient. interview in October 2004 Reader's Di gest, www.rd.com/contentJopenContent.do?contentId= 13712. In one of his last public statements, Christopher Reeve conceded that embryonic stem cells were not showing promise for chronic spinal cord injury patients like himself. He had seen thc preliminary results of ESC trials in rats conducted by I-fans Keirstead of UC Irvine, now published in The Journal of Neuroscience (www.jneurosci.org/cgi/content/ abstract/25/19/4694 ). Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University In fact the modest improvements shown here in a few rats with spinal cord injury - improvements which occuned only if the cells were provided within days of the injury -- have been superceded by advances in adult stem cells. These cells have shown better results even in animal studies - see Senate testimony of Jean D. Peduzzi-Nelson, Ph.D., July 14, 2004, at www.stemcellresearch.org/testimony/peduzzi-nelson.htm. Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Chairman, Department of Pediatrics Loyola University Medical Center 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org Moreover, adult stem cells from patients' own nasal cavity (olfactory mucosa) have already been used in Portugal to benefit dozens of chronic spinal cord injury patients -- including several Americans who began to walk with braces after years of chronic paralysis. They have told their story in congressional testimony, http://my.webmd.com/content/ article/89/100250.htm, and on the PBS-TV program Miracle Cell, www.pbs.org/wnet/ innovation/transcripCepisode6.html. Unlike embryonic stem cell research, this approach is not receiving federal funds in the U.S. For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. -###5/23/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 8: BLOODY NONSENSE DO NO HARM The Coalition of Americans for Research FOUNDING Ethics MEMBERS Kevin Fitzgerald, S.J., Ph.D. Dr. Lauler Professor for Catholic Health Care Ethics; Associate Professor of Oncology, Georgetown University, C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Jefferson-Pilot Distinguished Professor in Primary Care; Assistant Dean for Generalist Programs; Professor of Pediatrics, Brody School of Medicine East Carolina University 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org The Senate may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding. political hype has often substituted for the scientific facts. This series will help members of the Senate distinguish mere politics from science. POLITICAL: "Well, let me make it very clear about adult stem cells or cord blood, There's not a researcher of any renown out there whatsoever, who believes that they can do anything more than help with blood related diseases, As a matter of fact 14 of the 15 diseases that people most die from in the United States of America can never be addressed by adult stem cells." -- Representative Michael Castle (R-DE), CNN Newsnight, 5/24/05 SCIENCE: . Adult stem cells "are currently the only type of stem cell commonly used to treat human diseases ... The clinical potential of adult stem cells has also been demonstrated in the treatment of other human diseases that include diabetes and advanced kidney cancer." National Institutes of Health, "Stem Cell Information: The official National Institutes of Health resource for stem cell research," Frequently Asked Questions (http://stemcells.nih,gov/info/ faqs.asp#success ). Research using adult stem cells -- including stem cells from cord blood -- has indeed had considerable success in treating such blood-related diseases as leukemia and sickle-cell anemia, But it has also shown benefits in treating human patients for non-blood related diseases such as cardiac disease, cancer, stroke, Parkinson's and spinal cord injury. Cardiac disease, cancer and stroke are the three top causes of death in the United States, according to the U.S, Centers for Disease Control ("Deaths: Preliminary Data for 2003," National Vital Statistics Reports, Vol. 53, #15, 2/05; online at: http://www,cdc,gov/nchs/data/nvsr/nvsr53/ nvsr53_15.pdf), Diabetes ranks as the 6th leading cause of death, Researchers at Massachusetts General Hospital have permanently reversed Type 1 (juvenile) diabetes in animal models using an adult cell treatment. Their results were published in Science on November 14,2003, They now have FDA approval to begin the first phase of clinical trials in human patients, Parkinson's disease is the 14th leading cause of death, Scientists at the 2002 annual meeting of the American Association of Neurological Surgeons presented research using a patient's own adult neural stem cells to successfully treat his Parkinson's; they noted such adult stem cells may be useful in treating other neurological conditions. See www.theratech.com/english/ press/2002/0408- 2002 .html. To date, not one human patient has been treated for any disease with embryonic stem cells, and their success in animal models has been very limited. For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org, -###7/12/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 9: MAKING A DIFFERENCE? DO NO HARM The Coalition of Americans for Research FOUNDING Ethics MEMBERS The Senate may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of the Senate distinguish mere politics from science. POLITICAL: "These extraordinary [embryonic stem] cells can generate a new heart muscle for those who have suffered cardiac damage, and new pancreas cells for diabetics, new brain cells for those with Parkinson's disease." - Sen. Edward Kennedy, hearing of the Health Subcommittee of the Senate Committee on Education, Labor and Pensions, 3/5/02 SCIENCE: Kevin Fitzgerald, S.J., Ph.D. Dr. Lauler Professor for Catholic Health Care Ethics; Associate Professor of Oncology, Georgetown University, C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmacology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Jefferson-Pilot Distinguished Professor in Primary Care; Assistant Dean for Generalist Programs; Professor of Pediatrics, Brody School of Medicine East Carolina UniverSity 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org Can they? Human embryonic stem cells do have the ability to form every tissue in the body are left to grow and differentiate as part of an intact human embryo. when they But in the lab, researchers have not succeeded in turning embryonic stem cells into pure cultures of specific, viable tissue types -- the essential first step if these cells are to have any therapeutic application. Even after 20 years of experience with mouse embryonic stem cells they have been unable to do this. "Scientists know this is a thorny problem," the New York Times reported in 2001, "but their views were not widely heard when the public and politicians seemed to assume that it was easy to grow any tissue type desired from embryonic stem cells. In fact, no one has been able to do this even with mouse cells ... The science is not even close." (G. Kolata, "A Thick Line Between Theory and Therapy, as Shown with Mice," New York Times, 12/18/01, p. F3). Today, while politicians still assume it's easy to grow any tissue from embryonic stem cells, the "thorny problem" remains: '''Just injecting stem cells is not going to work,' said Sahin Rafii, a physician and stem cell scientist at Cornell University Medical College. 'First, you have to be able to differentiate the cells into functional, transplantable tissues. We don't really know how to do this yet.'" -- S. Bloom, "Stem Cell Division," The Journal of Clinical Investigation, Vol. 1IS, #7, July 2005, p. 1677. "Although embryonic stem cells have been shown to have the potential to turn into virtually any cell type found within the body, no studies have demonstrated the controlled generation of a uniform cell type." -- Harvard Medical School professor Charles Vacanti, "Cells for Building," The Scientist, Vol. 18, #22,11/22/04, p. 22. For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. --###-7/14/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics - THE "POLITICAL SCIENCE" OF STEM CELLS LESSON DO NO HARM The Coalition of Americans for Research FOUNDING Ethics MEMBERS Kevin Fitzgerald, S.J., Ph.D. Dr. Lauler Professor for Catholic Health Care Ethics; Associate Professor of Oncology, Georgetown University, C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine Edmund Pellegrino, M.D. Center for Clinical Bioethics Georgetown University Medical Center David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Center for Clinical Ethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Jefferson-Pilot Distinguished Professor in Primary Care; Assistant Dean for Generalist Programs; Professor of Pediatrics, Brody School of Medicine East Carolina University 1100 H Street, NW Suite 700 Washington, DC 20005 PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org 10: You CAN'T ADVANCE SCIENCE BY DENYING SCIENCE The Senate may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such funding, political hype has often substituted for the scientific facts. This series will help members of the Senate distinguish mere politics from science. POLITICAL: Said on the Senate floor regarding the human embryo: "If in fact it is a human life -- it is not, by the way ... " - Senator Richard Durbin (D-IL), July 29,2005 SCIENCE: The early embryo is not only "alive" in the sense that all human cells are, but is a human life, the first stage in the development of any human being. To deny this, in order to justify destroying human embryos for research, is to deny science to advance an ideology. "Zygote. This cell results from the union of an oocyte and a sperm during fertilization. A zygote is the beginning of a new human being (i.e., an embryo)." Moore, Keith L. and Persaud, T.V.N. The Developing Human: Clinically Oriented Embryology. 7th edition. Philadelphia: Saunders 2003, p. 2. "At the moment the sperm cell of the human male meets the ovum of the female and the union results in a fertilized ovum (zygote), a new life has begun." Considine, Douglas (ed.). Van Nostrand's Scientific Encyclopedia. 5th edition. New York: Van Nostrand Reinhold Company, 1976, p. 943. "The development of a human begins with fertilization, a process by which the spermatozoon from the male and the oocyte from the female unite to give rise to a new organism, the zygote." Sadler, T.W. Langman's Medical Embryology. 7th edition. Baltimore: Williams & Wilkins 1995, p. 3. "Fertilization is a sequence of events that begins with the contact of a sperm (spermatozoon) with a secondary oocyte (ovum) and ends with the fusion of their pronuclei (the haploid nuclei of the sperm and ovum) and the mingling of their chromosomes to form a new cell. This fertilized ovum, known as a zygote, is a large diploid cell that is the beginning, or primordium, of a human being." Moore, Keith L. Essentials of Human Embryology. Toronto: B.C. Decker Inc, 1988, p.2. "Almost all higher animals start their lives from a single cell, the fertilized ovum (zygote) ... The time of fertilization represents the starting point in the life history, or ontogeny, of the individual." Carlson, Bruce M. Patten's Foundations of Embryology. 6th edition. New York: McGraw-Hill, 1996, p. 3. For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. -###- 7/29/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates, The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 11: NOT MONTHS OR DAYS, BUT DECADES Congress may vote soon on whether to divert taxpayer dollars toward stem cell research that requires destroying live human embryos. In the campaign to promote such federal subsidies, political hype has far distanced itself from what science tells us. This series will help members of Congress distinguish mere politics from science. POLITICAL: The Coalition of Americans for Research FOUNDING Ethics MEMBERS "People are dying from diseases and medical conditions that might be cured through embryonic stem-cell research. For these people, every month matters. And every day of delay by the Senate has life-and-death consequences." Sen. Tom Harkin in Roll Call, Sept. 23,2005 SCIENCE: Kevin Fitzgerald, S.J., Ph.D. Dr. Lauler Professor for Catholic Health Care Ethics; Associate Professor of Oncology, Georgetown University, C. Christopher Hook, M.D. Hematology/Medical Oncology, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee "Much of the California electorate was sold last year on the idea that human embryonic stem cells might be turned into amazing cures for incurable diseases, propelling Proposition 71 to easy victory in the Nov. 2004 election. Now, it's increasingly clear that stem cell transplants for diabetes or Parkinson's or Alzheimer's are nowhere close, maybe decades away." - Science writer Carl T. Hall, "Stem Cell leaders to talk strategy at conference," The San Francisco Chronicle, Sept. 30, 2005, page B4 Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Visiting Professor Center for Clinical Bioethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Jefferson-Pilot Distinguished Professor in Primary Care; Assistant Dean for Generalist Programs; Professor of Pediatrics, Brody School of Medicine East Carolina University 1100 H Street, NW Suite 700 W,,~hinoton nr 7000c; PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org "One of the problems is that in order to persuade the public that we must do this work; we often go rather too far in promising what we might achieve ... I am not entirely convinced that embryonic stem cells will, in my lifetime, and possibly anybody's lifetime for that matter, be holding quite the promise that we desperately hope they will." - British stem cell expert Professor Lord Winston, Lecture at Gresham College, June 20, 2005, www.gresham.ac. uk/printtranscript. asp ?EventId=34 7 "[I]t is necessary that prospective [egg] donors recognize the large gap between research and therapy ... [R]esearchers must make every effort to communicate to these volunteers that it is extremely unlikely that their contributions will directly benefit themselves or their loved ones. Also, it is nearly certain that the clinical benefits of the research are years or maybe decades away. This is a message that desperate families and patients will not want to hear." - David Magnus and Mildred K. Cho of Stanford University, "Issues in Oocyte Donation for Stem Cell Research," Science, 17 June 2005, p. 1748 "[R]esearchers say it could be decades before embryonic stem cells cure anything." - Helen Fields, "Reigniting the Stem Cell Debate," U.S. News and World Report, June 6, 2005, www.usnews.com/usnews/news/articles/050606/6politics.bl.htm For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. -###12/5/05 "As to diseases ,make a habit of two things to help, or at least do no harm." - Hippocrates. The Epidemics- THE "POLITICAL SCIENCE" OF STEM CELLS LESSON 12: DON'T THROW AWAY THE FUTURE The political campaign for embryonic stem cell research risks doing great harm, by ignoring or even blocking stem cell treatments that could help many thousands of suffering patients here and now. Politics should not trump scientific fact and patients' lives. DONO HARM The Coalition of Americans for Research POLITICAL: "There are also cord blood stem cells. But the real opportunity for medical advance lies in the flexible embryonic stem cells ... " - Sen. Arlen Specter, Congo Record, Oct. 21. 2005, p. S 11729 Ethics SCIENCE: FOUNDING MEMBERS Kevin Fitzgerald, S.J., Ph.D. Dr. Lauler Professor for Catholic Health Care Ethics; Associate Professor of Oncology, Georgetown University, Umbilical cord blood stem cells can now help suffering patients with six dozen illnesses, and show promise in treating many more. Due to a lack of national coordination and funds for cord blood banking, 4 million samples of cord blood are discarded in hospital nurseries every year - a tragedy that Washington-area Channel 4 News calls "throwing away the future." C. Christopher Hook, M.D. Hemato/ogyjMedical.Onco/ogy, The Mayo Clinic (MN); Chair, Mayo Clinical Ethics Council, Mayo Reproductive Medicine Advisory Board and DNA Research Committee Ralph Miech, M.D., Ph.D. Associate Professor (Emertius) of Pharmocology Brown University School of Medicine Robert D. Orr, M.D. Director of Ethics, FAHC University of Vermont College of Medicine David Prentice, Ph.D. Senior Fellow for Life Sciences Family Research Council Visiting Professor Center for Clinical Bioethics Georgetown University Frank E. Young, M.D., Ph.D. Former Commissioner, U.S. Food and Drug Administration; Dean Emeritus, School of Medicine and Dentistry, University of Rochester; Director, Reformed Theological Seminary, Metro Washington Joseph Zanga, M.D. Jefferson-Pilot Distinguished Professor in Primary Care; Assistant Dean for Generalist Programs; Professor of Pediatrics, Brody School of Medicine East Carolina University 1100 H Street, NW Suite 700 W,,~hinoton nr 7000<; PH: 202-347-6840 Fax: 202-347-6849 www.stemcellresearch.org "Writing in the New England Journal of Medicine, researchers at Duke University Medical Center reported that infants born with a fatal nerve disorder have been helped -- and perhaps even saved -- by treatment with stem cells taken from the umbilical cords of healthy babies ... The target in this case was Krabbe's disease, a devastating enzyme disorder that prevents the nerve fibers in babies' brains from developing the myelin insulation they need, leading to blindness, deafness, cognitive deterioration and death before age 2 .... 'Our oldest survivor is 6 1/2,' says [lead author Dr. Maria] Escolar. 'She's now running, jumping and doing well in schooL'" "Stem Cells Save Babies," TIME, May 30, 2005, p. 59. "Early research in animals suggests that cord blood may provide a new bounty of cures and treatments for many other medical conditions, including heart attack, Parkinson's disease, stroke, Alzheimer's disease, muscular dystrophy, diabetes, spinal cord injury and amyotrophic lateral sclerosis. 'This is all new biology, which could have an unlimited potential,' said Dr. Paul Sanberg, director of the University of Southern Florida's center for aging and brain repair." - "Medical hope in umbilical cord blood; researchers find its healing powers may provide cures for many deadly maladies," Chicago Tribune, October 23,2005, www.chicagotribune. com!technology/chi-051 02305160ct23, I ,2647650.story?coll=chi-techtopheds-hed "Most hospitals discard cord blood after a baby's birth, despite the fact that the blood contains stem cells that can be used in transplants for as many as 80 serious medical problems. Those include the most prevalent types of leukemia, metabolic disorders like Tay-Sachs disease, bloodrelated conditions such as sickle cell anemia and severe anemia problems. 'People literally are dying on the transplant list who could be cured with this,' said Dr. Brian Mason [ob/gyn at Detroit's St. John Hospital]." - "Babies Provide Lifelines; Umbilical Cord Stem Cells Aid in Transplants for Leukemia Patients, Others," Charlotte Observer (North Carolina), November 7, 2005, http://stemcellnews.com!articles/stem-cells-cord-blood-coali tion .htm For more information to help distinguish politics from science on stem cell research, see our web site at www.stemcellresearch.org. ---###12/15/05