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Ethical and Public Policy Issues Concerning Stem Cell Research
A forum for discussion
Written by Becky Davis, Paul Riccio, and Meika Hashimoto, and edited by Scott Gilbert
Stem cells are unique cells that are undifferentiated and have the ability to self-replicate indefinitely. Many different kinds of stem cells have been discovered; the types most commonly used in research include embryonic, fetal and adult stem cells. Stem cell research has the potential to provide an increased understanding of development and differentiation, as well as leading to treatments and cures for many diseases. However, attaining this potential is no simple task. In additions to the research difficulties, many ethical viewpoints must be reconciled. Research utilizing stem cells is currently a subject of intense ethical scrutiny. Opinions of what should and should not be done form a broad spectrum. The views range from support of research done on stem cells derived from embryos created expressly for that purpose, to opposition to any form of stem cell research. A global discourse concerning the use of stem cells is well established. Scientists, ethicists and politicians contribute, employing many systems of ethical analysis, such as religious perspectives and feminist critique. In addition, a flood of legislation has ensued with the announcement of successful stem cell derivation. Countries must grapple with the scientific and social implications of stem cell research as well as decided whether to publicly fund this research. The world is in a period of transition where moral judgments are increasingly overridden by competition to discover new techniques and applications to patent and market.
Ethical Issues in Stem Cell Research
Christopher Reeve, the former actor who became paralyzed in 1995, has become one of the most visible advocates for stem cell research. The Christopher Reeve Paralysis Foundation is a multimillion-dollar nonprofit organization that, among other activities, distributes grants to researchers manipulating stem cells. In many public appearances Christopher Reeve proclaimed that by his fiftieth birthday he, like the mice in John McDonald's laboratory at Washington University, would receive spinal chord stem cell implants that would lead to neurological regeneration. Applications of stem cell therapy to animal models of disease have worked remarkably well. Success with human models, however, still seems a distant future.
The case of Christopher Reeve serves to demonstrate how strong public expectations for stem cell research are. The magnitude of hope for positive benefits from stem cell research creates a great paradox. Stem cell research can potentially transform health care and biological understanding, but utilizing stem cells themselves remains an incredibly controversial issue. Stem cell research has been the subject of intense ethical scrutiny. The reasons for this are many, but effectively revolve around the sources of stem cells.
Erik Parens of the Hastings Center describes the reasons for such scrutiny, stating that, "Medical progress is a very great good... it does not trump the good of transparent and respectful public debate. It is ultimately (if not immediately) in everyone's best interest to be as clear as possible about the facts. One of those is that ES cell research cannot be done without destroying embryos..."(10) Human embryonic stem cells (hES) are obtained from embryos. Embryonic germ cells (hEG) are derived from the developing fetus. Stem cells created by somatic cell nuclear transfer (SCNT) require an enucleated oocyte and in vitro fertilization requires both egg and sperm. The use of embryos in any stage of development has long been a controversial topic. Human adult stem cells (hAS) are by far the least controversial research material. Stem cell research has not only augmented the scope of this debate, but has brought it to the forefront of bioethical debates.
While the source of the stem cells is the major focus of ethical debate, issues such as the application of any potential technology derived from stem cell research are widely discussed. Consideration of these issues is ongoing, but scientists, theologians, governments, and private corporations have all reached some conclusions about what should and should not be done with stem cells. There is no distinct dichotomy in this discourse—opinions cannot be described as solely in favor of or against stem cell research.
In 1999 The National Bioethics Advisory Commission of the United States produced a two-volume response to President Clinton's request for a review of the issues, both medical and ethical, related to stem cell research. In these documents the NBAC presented the president with thirteen recommendations concerning stem cell research:
Perhaps the most important recommendations reflect the Commission's view that federal sponsorship of research that involves the derivation and use of human embryonic stem cells and human embryonic germ cells should be limited in two ways. First, such research should be limited to using only two of the current sources of such cells; namely, cadaveric fetal material and embryos remaining after infertility treatments. Second, that such sponsorship be contingent on an appropriate and open system of national oversight and review.
This quotation illustrates what the NBAC considered to be the major ethical conflicts. The commission clearly supported stem cell research and found any conflicts to lie within the issue of the source of the stem cells. While cells obtained from aborted fetuses and unused embryos from fertility clinics were seen as permissible research material, the commission did not support the creation of blastocysts for cell harvesting through either in vitro fertilization or SCNT. The remaining recommendations addressed the donation of fetal material and suggested the prohibition of its sale.(12) Adult stem cells were not addressed, as at that time they were not considered to hold much therapeutic potential.
The actual portion of the two volumes that presents the commissions conclusions is relatively small. Most of the text is devoted to summarizing testimonies and presenting essays commissioned by the NBAC. While the report is titled Ethical Issues in Human Stem Cell Research, the extent of the ethical interpretation made by the NBAC could be described through this short passage: "In light of public testimony, expert advice, and published writings, we have found substantial agreement among individuals with diverse perspectives that although the human embryo and fetus deserve respect as forms of human life, the scientific and clinical benefits of stem cell research should not be foregone."(12) The perspective presented here is not based on moral evaluation of issues involved in stem cell research, but rather on a governmental ideal: rule of the majority. This is perhaps a moot point, as the NBAC suggestions of 1999 no longer reflect United States policy; the policy of current President Bush is much more restrictive of which stem cell research the government will fund.
Some ethicists have been critical of the NBAC report. A great deal of the report approaches questions on stem cell research with material that is not directly ethical analysis. This is contradictory to its very title. Several essays discuss existing laws concerning fetal material as an ethical framework, without examining the ethical principles behind these laws. Other passages and presentations are focused on the constitutionality of stem cell research and whether it should be regulated by state or the federal government. Another more governmentally rather than ethically focused perspective in the NBAC report equates stem cell research with the Cold War era space race: "Federal funding is probably required in order for the United States to sustain a leadership position in this increasingly important area of research."(12) If such conclusions constitute ethical analysis at all, the ethical model could best be described as an ends verses means approach.
Another criticism of the ethical theory used by the NBAC is summarized by John C. Fletcher: "They [NBAC] assumed, on the basis of scientists' testimony, that hES cells are more promising for therapy than AS cells. They thus placed the burden of scientific proof on those who believe that AS cells are a preferable alternative."(10) This criticism is highly controversial as most scientists maintain hES cells have more pluripotency than hAS cells, but by no means is it a trivial ethical perspective. Many individuals and groups suggest that as the benefits of stem cell research have not yet been realized, it is most ethically desirable to pursue instead other less controversial lines of research focused on the same goals.
Yet more extreme are those who oppose all research on hES cells but support the use of hAS cells. One such group is Do No Harm; The Coalition of Americans for Research Ethics. Their philosophy can be summarized by this statement, which appears on the coalition's website: "Obtaining stem cells from people without seriously harming people in the process can be ethical. However, obtaining stem cells from human embryos cannot be ethical because it necessarily involves destroying those embryos." Members of this group base their ethical conclusions on a belief that embryos hold the same moral status as fully developed humans.
Suzanne Holland, who served as co-chair of the 2000-2001 Program Committee of the American Society of Bioethics and Humanities, explains that some may ethically object to stem cell research not only because of issues over the status of embryos, but out of concern for women. Feminist ethical critique of stem cell research mainly focuses on the question of where eggs for IVF or SCNT will come from and how accessible any therapeutic developments will be: "We would do well to subject public policy in question to the scrutiny of a moral litmus test that ensures the least well-off among us that they will be as likely to benefit as the most advantaged. Justice demands no less."(10)
Among the groups that support human stem cell research, many espouse the theory that the potential of stem cell research to heal takes moral precedence over controversy of how the cells are obtained. Lawrence Goldstein, a researcher at the University of California, San Diego School of Medicine and member of the American Society for Cell Biology made this argument in a testimony before the Labor, Health & Human Services and Education Subcommittee of the Appropriations Committee of the United States Senate, saying "Stem cell research, in particular, has enormous potential for the effective treatment of human disease. Thus we believe that there is a moral imperative to pursue it in an ethically validated manner." In the testimony Dr. Goldstein was not clear about what he meant by "ethically validated manner." In the context of the testimony, however, further development of this statement was not necessary, as the primary ethical justification for stem cell research was not based on an analysis of the ethicality of destroying embryos, but upon a belief system in which the greatest value is placed upon the potential to heal. The American Medical Association and the Coalition for the Advancement of Medical Research are two other groups that have adopted nearly identical views to the American Society for Cell Biology.
The lobbying efforts of such groups have influenced the opinions of many, including Senator Orrin Hatch. He supports the use of stem cells obtained by SCNT. Interestingly, he describes his ethical theory as applying a pro-life perspective: "I analyzed this issue from a pro-life, pro-family perspective, with the conviction that being pro-life demands helping the living... The absence of a fertilized egg coupled with a legal prohibition against implantation leads many, including me, to conclude that this research can be conducted, with appropriate safeguards, in an ethically proper fashion."
This ethical perspective in part coincides with the views of the AMA and other groups, but adds another level of justification. This additional view contends that an embryo holds moral status, but this status is not equivalent to that of a developed human unless the embryo is implanted into a woman's uterus.(17)
The inclusion of Senator Hatch's viewpoints in this report serves to illustrate an important aspect of the ethical discourse on stem cell research; that many different groups and individuals are involved. Scientists, governments, special interest groups, and ethicists have all offered unique ethical perspectives. Another group of participants has been private corporations. This is perhaps unexpected as the research activities of such companies are not directly regulated by the government. Geron Corporation, a biotechnology company in California, formed the five member Geron Ethics Advisory Board (GEAB) shortly after beginning research on stem cells.(10) The ethical conclusions reached by private corporations and such advisory boards have always been supportive of stem cell research. Laurie Zoloth, who was a member of the GEAB, recalls the experience:
At Geron, we were given white coats and taken to the lab where we saw beautiful new beating cardiac cells, the exquisite intricacy of newly differentiated structures. All who looked at the problem worried: if bioethicists stop this research and defeat the scientific vision, we might be doing an unthinkable moral wrong. Hence in report after report, we ethicists were strongly supportive of nearly anything that was suggested for further exploration, even while we struggled with the implications of medicine transformed by this science.(10)
Dr. Zoloth seems to imply that the bioethicists associated with private corporations promulgated theory, based not upon pure ethics, but as a consequence of intimate contact with the actual research. To counter this problem, some ethicists advocate applying analytic systems with clearly defined ethical axioms rather than depending upon philosophy that directly reacts to stem cell research itself. One example of this is the use of religious principles. Laurie Zoloth often applies her Jewish heritage in evaluating the ethical dimensions of stem cell research.
Religious perspectives have provided many ethical interpretations concerning the use of embryonic stem cells. Larry O'Connell, president and chief executive officer of the Park Ridge Center for the Study of Health, Faith, and Ethics believes consideration of religious perspectives is a useful ethical tool: "Theological categories and traditional religious teaching can illuminate moral pathways and provide conceptual categories without imposing theological conclusions." He also acknowledges the limitations of such perspectives in a secular society: "In a democraticoas distinguished from a theocraticosociety, particular religious perspectives must be advanced as one source of accumulated wisdom among others." Religion, while a useful starting point from which to reach ethical conclusions, should not be used as a definitive authority in deciding how to ethically use stem cells.
The NBAC document Ethical Issues in human Stem Cell Research, contains summaries of presentations made by religious ethicists representing the faiths of Catholicism, Judaism, the Eastern Orthodoxy, Islam, and Protestantism. Religions have been omitted and the summaries that do appear are brief. Although it is acknowledged that diversity of opinion among members of the same religious order may be abundant, the summaries attempt to consolidate these views into overarching ethical conclusions.
In an attempt to avoid accusations of bias, the commission presented the summaries in alphabetical order of the major names for each faith, beginning with Catholicism. The predominant Roman Catholic perspective, as described by the NBAC, is a restrictive one. The embryo is seen as a form of human life and as such is worthy of the moral status granted a fully developed human. Margaret A. Farley, a contributor to the NBAC presentations, describes the Catholic justification against stem cell use in a different way. This quotation appears in her essay "Roman Catholic Views on hES Cell Research": "At the heart of the tradition, however, is a conviction that creation is itself revelatory, and knowledge of the requirements of respect for created beings is accessible at least in part to human reason." She develops this statement to mean that conducting stem cell research would negate or be in defiance of the divinity of the creator.
These interpretations are associated with prohibition of all embryonic stem cell research. Research utilizing embryos created specifically for the obtainment of stem cells would be considered unethical. Cadaveric fetal tissue, whether resulting from clinical abortions or other sources is also not seen as permissible research material. The concept of "complicity" is central to this belief. Using discarded tissue in research, or in therapy derived from such research, would be inadvertent support of abortion.(10) The source of the stem cells has been a point of contestation among Roman Catholics though. For example some see somatic cell nuclear transfer (SCNT) as free from complicity with abortion while other Catholic ethicists state that research involving such cells is no different than using cells obtained from discarded embryos; in other words that it is not permissible. The use of human adult stem cells is also accepted by many Catholics; however, there by no means exists a consensus in the church.(12)
The conclusions reached by some Buddhist ethicists are similar to that within the Roman Catholic Church. Damien Keown, editor of the Journal of Buddhist Ethics describes the fundamental beliefs directing Buddhist ethical perspectives on embryonic stem cell use:
The Buddhist religion places great importance on the principle of ahimsa, or non-harming, and therefore has grave reservations about any scientific technique or procedure that involves the destruction of life, whether human or animal... Buddhism teaches that individual human life begins at conception. By virtue of its distinctive belief in rebirth, moreover, it regards the new conceptus as the bearer of the karmic identify of a recently deceased individual, and therefore as entitled to the same moral respect as an adult human being.(18)
This system of beliefs rather unambiguously leads to prohibition of research that utilizes hES cells. If major interpretive differences exist among Buddhist ethicists, these differences are not well known. Unfortunately there is very little literature on the application of Buddhist ethics to stem cell research.
As described by the NBAC, the Eastern Orthodox, Islamic, and Jewish ethicists are generally more receptive to stem cell research. The Eastern Orthodox perspective is primarily directed by a belief in the progression of each human toward the likeness of God, a progression which begins at conception. In this tradition life is sacred and elective abortion is seen as active defiance of "God's grace". As with Roman Catholicism, complicity with abortion is to be avoided by not conducting research on stem cells derived from aborted fetuses. The creation of embryos for obtaining stem cells is of course prohibited as well. The Eastern Orthodoxy does, however, approve of research done on cells obtained from certain other sources. These acceptances arise from a view that medicine is a divine gift. Humans have an obligation to heal. Research done on already existing cell lines or on stem cells obtained from miscarriages is more than accepted, but expected. The goals of any such research, however, must be focused towards medical therapy.(12)
The conclusions reached in Jewish ethics are very similar to those of the Eastern Orthodoxy. Elliot N. Dorff, a rabbi and professor of philosophy at the University of Judaism in Los Angeles, states that in the Jewish tradition, "Our bodies belong to God; we have them on loan during our life. God, as owner, can and does impose conditions on our use of our bodies. Among those is the requirement that we seek to preserve our life and health." This concept of a divine charge to heal has led many Jewish scientists and theologians to become strong proponents of stem cell research. Many of these people support research on cells obtained from aborted fetuses, but only if the abortion were for a legitimate medical reason such as danger to the mother's health or genetic testing identified the embryo as containing genetic mutations that lead to a terminal illness. Frozen embryos from fertilization clinics are also seen as ethically useable sources of stem cells.
Laurie Zoloth, director of the program in Jewish studies at San Francisco State University, says that halachah, the Jewish tradition of using sacred textual sources to reach ethical conclusions, almost always produces evidence to justify stem cell research itself. "It is mandated to use the best methods available as soon as they are proved efficacious and not dangerous to the patient. Paradoxically, it might violate rabbinic premises to stop [stem cell] research if such research is life saving." This statement shows the extent to which Jewish scholars may approve of stem cell research. She expresses concern, however, that such optimistic embrace of the research fails to acknowledge more specific problems arising from the logistics of research and the ultimate applications of any discoveries. For example, she describes the Jewish experience with the Holocaust as a poignant reminder of how devastating a social force eugenics can be. Laurie Zoloth questions whether utilizing stem cells will encompass not only therapeutic applications, but also self alteration; eugenics on a cellular level.(18)
There are a great number of opinions and beliefs of what should and should not be done with stem cells resulting from Jewish interpretations; Christian perspectives are equally numerous and diverse. The NBAC summary of religious views of stem cell research describes several Protestant interpretations. The most restrictive conclusions are obtained from views that, "... embryos are simply the weakest and least advantaged people among us." For many Christians, this view translates into equal moral status and protections for embryos as granted developed humans. Less restrictive views support research on cells obtained from discarded embryos at fertilization clinics, fetuses aborted for therapeutic reasons, and on hAS cells.(18)
Islamic interpretations lead to even greater tolerance of obtaining and doing research using embryonic stem cells. In an article published in the Canadian Medical Society Journal, titled "Bioethics for Clinicians: 21. Muslim Bioethics," Dr. Abdallah S. Daar and Dr. A. Binsumeit Al Khitamy provide a description of the belief which informs the Muslim perspective: "The general Islamic view is that, although there is some form of life after conception, full human life, with its attendant rights, begins only after the ensoulment of the fetus... most Muslim scholars agree that ensoulment occurs at about 120 days after conception; other scholars, perhaps in the minority, hold that it occurs at about 40 days after conception." This belief has lead Muslim ethicists to approve of stem cell research conducted on cells obtained from embryos aborted prior to ensoulment and on cells obtained from blastocyts created expressly for harvesting stem cells.
The British government has adopted a policy on stem cell research that is similar in approach to the Islamic perspective. In Britain it is widely accepted that the developing embryo does not attain full moral status until day fourteen of development, at which point gastrulation begins and identical twins can no longer form. This ethical conclusion has been converted into a policy which allows research on any embryonic material that is less than fourteen days old as well as embryos created by IVF and SCNT. For a former University of California, San Francisco researcher, Roger Pederson, the British policy on stem cell research is clearly ethically acceptable as he recently defected to a British institution.
The frustration of Roger Pederson is in some ways a testament to the fact that stem cell research is proceeding independent of the ethical discourse surrounding it. In the United States, stem cell research in the private sector will continue regardless of government policy, which currently affects only governmentally funded research. John Fletcher, Professor Emeritus of Biomedical Ethics and Internal Medicine at the University of Virginia School of Medicine, suggests that, "public bioethics must be concerned with the politically possible to achieve the right balance between competing factors, especially on such a controversial issue."(10) Throughout most of the Western world, stem cell research is a political possibility. Therefore, ethical discourse concerning stem cell research must not end, but simply change focus. This new focus is the question of regulation. At a University of Pennsylvania School of Medicine symposium held in April 2002, John Gearhart made an appeal for regulatory mechanisms that would keep stem cell research ethically focused: "More peer review is really sorely needed in this field. It doesn't seem to matter anymore whether you publish something by peer review, or whether you call your favorite reporter and say, 'Look what we've done,' and publish it in the media. I'm very concerned about this." It seems his concern should be easy enough to address. The ethical discourse surrounding stem cell research is well established; it is simply time to change focus from whether or not stem cell research should be done, to how it should be regulated.
The History and Public Policy of Human Embryonic Stem Cell Research
Human embryonic stem cell research is a source of major political controversy. Many countries are in the midst of developing their own public policies, exploring ethical issues, and competing between each other to discover applications, and consequent economic gains, resulting from stem cell research. Although intensely debated, arguments over the ethics of hES cell research seem superseded due to approval of research in specific places. With unregulated private research and approval of public funding in certain countries, stem cell research will continue to progressothe only question is where. This section contains a brief history of hES research, particularly in the United States, and examines issues concerning public policy and funding throughout the world.
The stem cell debate in the United States began as early as 1973 with Roe. Vs. Wade when the Supreme Court ruled that a fetus did not have the rights of a person. This decision, in addition to legalizing abortion, also raised issues over research on aborted fetuses. The National Institute of Health imposed a moratorium on fetal research, and one year later, Congress established the National Commission, charging it with formulating ethical and public policy guidelines concerning the subject. On July 29, 1995, the commission issued its report, supporting fetal research for therapeutic purposes, yet firmly stating that fetuses to be aborted must be treated exactly like fetuses that were to live. Research could only be done if it posed "minimal risks" to the fetus, which was defined as "not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests(10)." However, the "minimal risk" standard was abandoned in 1984 when public law eliminated federal support for fetal research that involved any level of risk.
The U.S. government's opinion of research changed briefly in 1993 when Congress lifted a ban on in vitro research, but later in the year it switched once more to prohibit federal funding for embryo research. In September 1994, the Human Embryo Research Panel, which was created by the National Institutes of Health, completed a report that recommended federally funded embryo research; but despite this proposal, the ban continued to exist. In 1996, James Thomson at the University of Wisconsin and John Gearhart at Johns Hopkins University simultaneously created embryonic stem cells and publicly announced in 1998 that such a feat was possible. Previously, scientists had been unable to derive successful lines of hES cells. Thomson and Gearhart's accomplishments once more opened up the controversy over stem cell research, only this time the advocates pushing for federal research knew that embryonic stem cells could be derived from humans.
This declaration sparked a tide of government response. Clinton created the National Bioethics Advisory Commission (NBAC) in September 1998 to investigate the issues surrounding human embryonic stem cell research and asked them on November 14 to do so, "balancing all ethical and medical considerations." In September 1999, NBAC issued a report, Ethical Issues in Human Stem Cell Research, giving thirteen recommendations to Clinton and his administration. It supported federal funding for researching embryonic germ and embryonic stem cells from cadaveric fetal tissue and remaining embryos in infertility treatments.(23) NBAC emphasized that the only hES cells that could be used for research were to be from individuals who had already decided not to store them or donate them to another couple, and that EG and ES cells could not be bought or sold. NBAC emphasized that stem cell research "is not intended to provide medical benefit to embryo donors, the research will involve the destruction of the embryos, and the embryos used in research will not be transferred to a woman's uterus."(23) Furthermore, donors could not request that their embryos be used in specific area of research, consequently eliminating any self-interest reasons for donating. NBAC also proposed that Congress allow the derivation of ES cells as an exception to the embryo research ban.
NBAC's recommendations were included a series of hearings that began in December 1998 and lasted until September 2000. The National Institutes of Health gathered prominent people in the stem cell debate, including researchers, professors, and actors, and presented them to a Senate subcommittee of the Committee on Appropriations during seven sessions over the course of two years. The material gathered from these hearings was made into guidelines that NIH policy makers took into consideration when debating over hES research funding. These guidelines included many of NBAC's opinions. Researchers needed to provide documentation to prove that they derived pluripotent stem cells from the excess embryos of fertility clinics. The donating individual could not receive any monetary compensation. The researcher had to carefully document his or her research and present it to the NIH. The NIH would not fund projects that created embryos solely to destroy them for research purposes. Additionally, researchers applying for grants would bear extra scrutiny from a newly created NIH group called the Human Pluripotent Stem Cell Review Group, which would review documentation of research grant requests and subsequently recommend funding according to compliance with the NIH guidelines.(23) Both NBAC and the NIH guidelines helped shape American public policy toward hES research during the initial years after Thomson's experiment when discussion over government regulation became necessary.
NBAC existed until October 3, 2001, when its charter ended and President Bush established his own bioethics commission (The President's Advisory Board) to examine the same issues that NBAC had seen during the Clinton administration. On August 9, 2001, Bush made a statement concerning hES research. He decided to accept sixty-four stem cell lines that had pre-existed before August 9, and invest $250 million in research using these lines. However, federal funds could not be used for the cloning of human embryos, the derivation of stem cell lines after this date, or the creation of human embryos for research purposes . In addition to his promise to fund stem cell research, on February 4, 2002, Bush asked Congress to increase the NIH's budget to $27.3 billion for the FY 2003 budget. In 1998, the NIH's budget was only $13.6 billion.
On January 16, 2002, Bush created the President's Council on Bioethics, naming seventeen scientists, doctors, ethicists, social scientists, lawyers, and theologians to examine the issues surrounding biomedical science. The council's main objective is to advise the president on biomedical ethical matters, and it has met and will meet each month, except August, for the remainder of the 2002 year. Currently working on papers concerning bioethical matters, the council has gathered a range of views that encompass the full scope of opinions concerning human reproductive cloning as well as proper terminology and policy considerations.
Bush established the President's Council only two days before the National Academy of Sciences (NAS), a government advisory group that counsels the government on scientific issues, released their recommendations on human cloning. A NAS panel consulted experts in areas such as medical and legal policy, animal cloning, and pro-cloning groups to discuss the issues surrounding human reproductive cloning. On January 18, 2002, the panel called for a ban on human reproductive cloning in the United States, citing the danger of the procedure, the extremely low success rate of animal cloning, and the risk of the egg donor, the woman carrying the baby, and the cloned child. However, the panel did not object to the nuclear transfer technique or the cloning of embryos to extract stem cells for treating diseases. A further suggestion was to revisit the issue of human reproductive cloning in five years if techniques for cloning became safer or if public opinion called for another review of the issues .
Despite the breadth of U.S. influence concerning hES cells, the debate is not limited to the United States. Many other countries have confronted the issue and reached varied answers. In Denmark, Finland, Hungary, Spain, Sweden, and the United Kingdom, hES cell research and hES cell derivation are regulated by law, while the Netherlands and Portugal are currently working on creating laws. Austria, Ireland, and Norway have prohibited stem cell research, while France is in the midst of allowing research after previously banning it. Australia only allows research on imported ES cell lines; Israel allows the derivation of hES cells from 'spare' IVF embryos, and Japan monitors hES cell derivation and prohibits reproductive cloning . China has begun to build its first state-run cell complex which will include a stem cell bank, a transplant center, and a stem cell engineering development center. Germany has banned hES cell production since 1990, but on January 30, 2002, it approved limited imports of hES cells for research.
Although European countries are divided in their decisions concerning stem cell research, the general trend leans toward the approval of research as a part of scientific inquiry. On November 14, 2001, the European Parliament approved of a report that recommended that hES research be funded if the state permits it, but also warned that therapeutic and reproductive cloning research would not be given support. Fifteen days later, the European Parliament rejected, by a large majority, a report that examined the ethical aspects of human genetics research and advised the European Commission to ban reproductive and therapeutic cloning and prohibit public funding for hES research. However, the report was not rejected because of its recommendation, but because of its ambiguous nature. The original document had been amended 550 times, and the committee members who wrote it disagreed over its final recommendation: 18 members were for banning, 13 were against it, and three abstained from voting. Ultimately, most of the European Parliament agreed that it was too contradictory to be accepted.
Many issues arise from the ongoing stem cell debate over the ethical and the unethical, private versus public, economics versus humanitarian issue, and progress versus exploitation. Though the U.S. government imposes restrictions for federal funding of hES cells, the private sector of research remains free of restraints, except in states that specifically prohibit all hES research. In the case of government funding, all results must be made publicly known, but private companies have the ability to conceal their findings.(10) Without help from the government, hES research and the development of therapeutic cloning is entirely market-driven, and can lead to potentially dangerous and reckless research.
This strategy of laissez-faire is made more acute by the Bayh-Dole Act of 1980. This Act permits federally funded programs to retain the intellectual property rights for their research, and allows researchers to hold patents on their discoveries, especially the ones concerning profit. However, any new invention, even with a patent, is subject to further research in other government-funded laboratories. The goals of this Act were to encourage the commercialization of technology, boost economic development, and give the U.S. a competitive edge over other countries by allocating government funds to technology-developing institutions.(23) The Act effectively fused intellectual research with industry, and in the area of biotechnology, biology and commercialization have almost become synonymous.
Although the commercialization of biotechnology may seem dangerous due to exploitative incentives, certain measures have been taken to confront moral issues. Geron, the company that privately sponsored both Thomson and Gearhart's experiments, established its own advisory commission in July 1998 to explore the ethical issues concerning stem cell research(23). The vice-president of research and development, Dr. Thomas B. Okarma, participated in the NIH hearings and outlined the rules for Geron's research which included:
"Treating the cells with appropriate respect due to early developmental tissue; obtaining full and informed consent from donors of the tissue; no reproductive cloning of human beings; accord for accepted normals of animal research; concern for global justice and the use of best efforts to develop and utilize the technology for all people, and participation by an independent advisory board, in addition to an institutional review board, to assess the appropriateness of each research protocol." (23)
Geron is a private commercial company: the stem cell lines it maintains are sold for profit, yet it follows self-imposed guidelines. However, other private companies have not taken such actions. One company's attempt to formally explore the ethical issues of embryonic stem cell research does not imply that all companies will follow suit. Indeed, Geron was the sponsor of both Thomson and Gearhart's experiments that led to the successful derivation of hES cells.
Another issue that arises from the opportunities that hES cells offer is competition. If research is done purely for economic profit, then companies will (and do) jealously guard their research secrets, effectively preventing a total collaboration of interests on the subject. Moreover, hES cell research is not restricted in other countries such as Great Britain and Canada, which could result in scientists moving to these places in order to further their research without worrying about federal bans.
We still do not know where the future of embryonic stem cells will lead us. Whether it becomes normal practice or highly restricted, whether embryonic, fetal, or adult stem cells are used, there are many potential applications for stem cells that hold significant promise. We must walk carefully along the intricate pathways that hES cells create, and seek to understand its nuances while maintaining respect for human life.
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