"California Cloning: A Dialogue on State Regulation" was convened October 12, 2001, by the Markkula Center for Applied Ethics at Santa Clara University. Its purpose was to bring together experts from the fields of science, religion, ethics, and law to discuss how the state of California should proceed in regulating human cloning and stem cell research.
A framework for discussing the issue was provided by Center Director of Biotechnology and Health Care Ethics Margaret McLean, who also serves on the California State Advisory Committee on Human Cloning. In 1997, the California legislature declared a "five year moratorium on cloning of an entire human being" and requested that "a panel of representatives from the fields of medicine, religion, biotechnology, genetics, law, bioethics and the general public" be established to evaluate the "medical, ethical and social implications" of human cloning (SB 1344). This 12-member Advisory Committee on Human Cloning convened five public meetings, each focusing on a particular aspect of human cloning: e.g., reproductive cloning, and cloning technology and stem cells. The committee is drafting a report to the legislature that is due on December 31, 2001. The report will discuss the science of cloning, and the ethical and legal considerations of applications of cloning technology. It will also set out recommendations to the legislature regarding regulation of human cloning. The legislature plans to take up this discussion after January. The moratorium expires the end of 2002.
What should the state do at that point? More than 80 invited guests came to SCU for "California Cloning" to engage in a dialogue on that question. These included scientists, theologians, businesspeople from the biotechnology industry, bioethicists, legal scholars, representatives of non-profits, and SCU faculty. Keynote Speaker Ursula Goodenough, professor of biology at Washington University and author of Genetics, set the issues in context with her talk, "A Religious Naturalist Thinks About Bioethics." Four panels addressed the specific scientific, religious, ethical, and legal implications of human reproductive cloning and stem cell research. This document gives a brief summary of the issues as they were raised by the four panels.
Thomas Okarma, CEO of Geron Corp., launched this panel with an overview of regenerative medicine and distinguished between reproductive cloning and human embryonic stem cell research. He helped the audience understand the science behind the medical potential of embryonic stem cell research, with an explanation of the procedures for creating stem cell lines and the relationship of this field to telomere biology and genetics. No brief summary could do justice to the science. The reader is referred to the report of the National Bioethics Advisory Committee (http://bioethics.georgetown.edu/nbac/stemcell.pdf) for a good introduction.
Responding to Okarma, were J. William Langston, president of the Parkinson’s Institute, and Phyllis Gardner, associate professor of medicine and former dean for medical education at Stanford University. Both discussed the implications of the president’s recent restrictions on stem cell research for the non-profit sector. Langston compared the current regulatory environment to the Reagan era ban on fetal cell research, which he believed was a serious setback for Parkinson’s research. He also pointed out that stem cell research was only being proposed using the thousands of embryos that were already being created in the process of fertility treatments. These would ultimately be disposed of in any event, he said, arguing that it would be better to allow them to serve some function rather than be destroyed. President Bush has confined federally-funded research to the 64 existing stem cell lines, far too few in Langston’s view. In addition, Langston opposed bans on government funding for stem cell research because of the opportunities for public review afforded by the process of securing government grants.
Gardner talked about the differences between academic and commercial research, suggesting that both were important for the advancement of science and its application. Since most of the current stem cell lines are in the commercial sector and the president has banned the creation of new lines, she worried that universities would not continue to be centers of research in this important area. That, she argued, would cut out the more serendipitous and sometimes more altruistic approaches of academic research. Also, it might lead to more of the brain drain represented by the recent move of prominent UCSF stem cell researcher Roger Pedersen to Britain. Gardner expressed a hope that the United States would continue to be the "flagship" in stem cell research. Her concerns were echoed later by moderator Allen Hammond, SCU law professor, who urged the state, which has been at the forefront of stem cell research to consider the economic impact of banning such activity. All three panelists commended the decision of the state advisory committee to deal separately with the issues of human cloning and stem cell research.
Two religion panelists, Suzanne Holland and Laurie Zoloth, are co editors of The Human Embryonic Stem Cell Debate: Science, Ethics and Public Policy (MIT Press, 2001). Holland, assistant professor of Religious and Social Ethics at the University of Puget Sound, began the panel with a discussion of Protestant ideas about the sin of pride and respect for persons and how these apply to human reproductive cloning. Given current safety concerns about cloning, she was in favor of a continuing ban. But ultimately, she argued, cloning should be regulated rather than banned outright. In fact, she suggested, the entire fertility industry requires more regulation. As a basis for such regulation, she proposed assessing the motivation of those who want to use the technology. Those whose motives arise from benevolence--for example, those who want to raise a child but have no other means of bearing a genetically related baby--should be allowed to undergo a cloning procedure. Those whose motives arise more from narcissistic considerations -- people who want immortality or novelty -- should be prohibited from using the technology. She proposed mandatory counseling and a waiting period as a means of assessing motivation.
Zoloth reached a different conclusion about reproductive cloning based on her reading of Jewish sources. She argued that the availability of such technology would make human life too easily commodified, putting the emphasis more on achieving a copy of the self than on the crucial parental act of creating "a stranger to whom you would give your life." She put the cloning issue in the context of a system where foster children cannot find homes and where universal health care is not available for babies who have already been born. While Zoloth reported that Jewish ethicists vary considerably in their views about reproductive cloning, there is fairly broad agreement that stem cell research is justified. Among the Jewish traditions she cited were:
The embryo does not have the status of a human person.
There is a commandment to heal.
Great latitude is permitted for learning.
The world is uncompleted and requires human participation to become whole.
Catholic bioethicist Albert Jonsen, one of the deans of the field, gave a historical perspective on the cloning debate, citing a paper by Joshua Lederburg in the 1960s, which challenged his colleagues to look at the implications of the then-remote possibility. He also traced the development of Catholic views on other new medical technologies. When organ transplantation was first introduced, it was opposed as a violation of the principal, "First, do no harm" and as a mutilation of the human body. Later, the issue was reconceived in terms of charity and concern for others. One of the key questions, Jonsen suggested, is What can we, as a society that promotes religious pluralism, do when we must make public policy on issues where religious traditions may disagree. He argued that beneath the particular teachings of each religion are certain broad themes they share, which might provide a framework for the debate. These include human finitude, human fallibility, human dignity, and compassion.
Lawrence Nelson, adjunct associate professor of philosophy at SCU, opened the ethics panel with a discussion of the moral status of the human embryo. Confining his remarks to viable, extracorporeal embryos (embryos created for fertility treatments that were never implanted), Nelson argued that these beings do have some moral status--albeit it weak--because they are alive and because they are valued to varying degrees by other moral agents. This status does entitle the embryo to some protection. In Nelson’s view, the gamete sources whose egg and sperm created these embryos have a unique connection to them and should have exclusive control over their disposition. If the gamete sources agree, Nelson believes the embryos can be used for research if they are treated respectfully. Some manifestations of respect might be:
They are used only if the goal of the research cannot be obtained by other methods.
The embryos have not reached gastrulation (prior to 14 to 18 days of development).
Those who use them avoid considering or treating them as property.
Their destruction is accompanied by some sense of loss or sorrow.
Philosophy Professor Barbara MacKinnon (University of San Francisco), editor of Human Cloning: Science, Ethics, and Public Policy, began by discussing the distinction between reproductive and therapeutic cloning and the slippery slope argument. She distinguished three different forms of this argument and showed that for each, pursuing stem cell research will not inevitably lead to human reproductive cloning. MacKinnon favored a continuing ban on the latter, citing safety concerns. Regarding therapeutic cloning and stem cell research, she criticized consequentialist views such as that anything can be done to reduce human suffering and that certain embryos would perish anyway. However, she noted that non-consequentialist concerns must also be addressed for therapeutic cloning, among them the question of the moral status of the early embryo. She also made a distinction between morality and the law, arguing that not everything that is immoral ought to be prohibited by law, and showed how this position relates to human cloning.
Paul Billings, co-founder of GeneSage, has been involved in crafting an international treaty to ban human reproductive cloning and germ-line genetic engineering. As arguments against human cloning he cited:
There is no right to have a genetically related child.
Cloning is not safe.
Cloning is not medically necessary.
Cloning could not be delivered in an equitable manner.
Billings also believes that the benefits of stem cell therapies have been "wildly oversold." Currently, he argues, there are no effective treatments coming from this research. He is also concerned about how developing abilities in nuclear transfer technology may have applications in germ-line genetic engineering that we do not want to encourage. As a result, he favors the current go-slow approach of banning the creation of new cell lines until some therapies have been proven effective. At the same time, he believes we must work to better the situation of the poor and marginalized so their access to all therapies is improved.
Member of the State Advisory Committee on Human Cloning Henry "Hank" Greely addressed some of the difficulties in creating a workable regulatory system for human reproductive cloning. First he addressed safety, which, considering the 5 to 10 times greater likelihood of spontaneous abortion in cloned sheep, he argued clearly justifies regulation. The FDA has currently claimed jurisdiction over this technology, but Greely doubted whether the courts would uphold this claim. Given these facts, Greely saw three alternatives for the state of California:
Do nothing; let the federal government take care of it.
Create an FDA equivalent to regulate the safety of the process, an alternative he pointed out for which the state has no experience.
Continue the current ban on the grounds of safety until such time as the procedure is adjudged safe. Next Greely responded to suggestions that the state might regulate by distinguishing between prospective cloners on the basis of their motivation, for example, denying a request to clone a person to provide heart tissue for another person but okaying a request if cloning were the only opportunity a couple might have to conceive a child. Greely found the idea of the state deciding on such basis deeply troubling because it would necessitate "peering into someone’s soul" in a manner that government is not adept at doing.
The impact of regulation on universities was the focus of Debra Zumwalt’s presentation. As Stanford University general counsel, Zumwalt talked about the necessity of creating regulations that are clear and simple. Currently, federal regulations on stem cells are unclear, she argued, making it difficult for universities and other institutions to tell if they are in compliance. She believes that regulations should be based on science and good public policy rather than on politics. As a result, she favored overall policy being set by the legislature but details being worked out at the administrative level by regulatory agencies with expertise. Whatever regulations California develops should not be more restrictive than the federal regulations, she warned, or research would be driven out of the state. Like several other speakers, Zumwalt was concerned about federal regulations restricting stem cell research to existing cell lines. That, she feared, would drive all research into private hands. "We must continue to have a public knowledge base," she said. Also, she praised the inherent safeguards in academic research including peer review, ethics panels, and institutional review boards.
SCU Presidential Professor of Ethics and the Common Good June Carbone looked at the role of California cloning decisions in contributing to the governance of biotechnology. California, she suggested, cannot address these issues alone, and thus might make the most useful contribution by helping to forge a new international moral consensus through public debate. Taking a lesson from U.S. response to recent terrorist attacks, she argued for international consensus based on the alliance of principle and self-interest. Such consensus would need to be enforced both by carrot and stick and should, she said, include a public-private partnership to deal with ethical issues. Applying these ideas to reproductive cloning, she suggested that we think about which alliances would be necessary to prevent or limit the practice. Preventing routine use might be accomplished by establishing a clear ethical and professional line prohibiting reproductive cloning. Preventing exceptional use (a determined person with sufficient money to find a willing doctor) might not be possible. As far as stem cell research is concerned, Carbone argued that the larger the investment in such research, the bigger the carrot--the more the funder would be able to regulate the process. That, she suggested, argues for a government role in the funding. If the professional community does not respect the ethical line drawn by politicians, and alternative funding is available from either public sources abroad or private sources at home, the U.S. political debate runs the risk of becoming irrelevant.
"California Cloning" was organized by the Markkula Center for Applied Ethics and co-sponsored by the Bannan Center for Jesuit Education and Christian Values; the Center for Science, Technology, and Society; the SCU School of Law; the High Tech Law Institute; the Howard Hughes Medical Institute Community of Science Scholars Initiative; and the law firm of Latham & Watkins.