THE PRESIDENT'S COUNCIL ON BIOETHICS DELIBERATIONS ON CLONING
President Bush set the following mandate for this Council: First, to monitor stem cell research and to recommend appropriate guidelines, and then to consider more broadly the medical and ethical ramification of biomedical innovation. Further, he asked that the Council help serve as the conscience of the country, to engage and educate the public and to advise him and the nation by articulating the strongest arguments on all sides of these difficult issues. Our initial assignment was to address the controversy over human cloning and its prospects for both reproductive and research purposes.
In reflecting on these dilemmas, it was immediately clear that we are at a defining moment in the progress of science. The choices our society makes now regarding ESCs (and other ethically controversial uses of biomedical technology) will put into place both the conceptual principles and practical foundations for future techniques of research and patterns of clinical practice. Once established, these moral precedents and scientific techniques will serve as the platform on which further practice will be built layer upon layer; like the foundations of a building, these will be difficult to retract or revise. There was an earnest intensity and sense of seriousness to the Council's discussion of these matters; we recognized that the issues are of broad significance for our civilization and, indeed, the future of our species. Therefore, the foundations we set must transcend pre-established cultural preferences and partisan political agendas; they must establish the basis for social consensus and global cooperation. We understood that without clear and distinct ethical principles, grounded in scientific evidence and reasoned moral argument, no policy could be effectively formulated or enforced.
The Council's discussion of the ethical issues centered around two poles, with the scientific and medical promise on the one hand, and the prudential and moral concerns on the other. Through a wide range of expert testimony and public comment, a compelling case was made for the importance of stem cell biology and its potential significance in medical application. The convergence of technologies following from advances in genomics, cytology, and developmental biology are delivering unprecedented powers for scientific research and intervention at the most basic levels of human biology. The fundamental questions of human embryology are opening up: studies of cell signaling, imprinting and differentiation, the positional cues that establish the body axes, body plan and patterns of organogenesis. An understanding of these basic biologic processes, together with a resource of ESCs from a full range of genotypes reflecting both normal and pathologic potentials, would provide extraordinary tools for the modeling of disease, studies of toxicology and testing of pharmaceuticals. An estimated 150,000 babies are born every year in the US with congenital defects, and evidence suggests that a range of later pathologies have their foundations in early development. Furthermore, basic developmental processes, and their disordered dynamics, seem to be at work in a number of adult pathologies including some forms of cancer. Notwithstanding the obvious hyperbole in the political promotion of ESC research ("128 million Americans with incurable diseases might benefit"), it seems clear that we truly are entering a new era of uncharted opportunity for scientific and medical advance. The age of regenerative medicine, cell therapies, tissue rejuvenation, and custom organ replacement seems conceptually real even if not within immediate reach. Far more than just ESC science is at stake; hanging in the balance are the wider scientific and medical prospects of this whole emerging era of discovery.
We recognized, however, that the same technological powers that offer such positive possibilities might also radically revise the traditional role of medicine. Clearly, increasing knowledge of reproduction and developmental biology could be used for purposes beyond therapy in the pursuit of broader human aspirations and ambitions. Disease and disability, the meaning of aging, and the significance of suffering all seemed at issue—and with them the open possibilities of human enhancement and dramatic extension of the human lifespan.
As we explored these matters, the debate deepened concerning the ultimate goals of our biomedical technology. Concerns were expressed about exaggerated expectations and images of human perfection. Some spoke of the imprudence of even entering such an arena of human enhancement and the danger in disrespecting the ordered goodness of the given world. They cited the increasing arrogance that is attending our advances in technological power as we override both the constraints of natural reality and the wisdom of traditional principles and prohibitions. And they warned that any encouragement of cloning of human embryos, for whatever immediate intentions, would provide the platform for the inevitable accomplishment of reproductive cloning. This, in turn, could set the stage for those promoting projects of "technological transcendence" through programs of eugenics and controlled evolution for the production of "posthumans" superior by design.
While pondering the scientific and medical meaning of cloning, in much of the scientific testimony and Council discussion there were efforts to distinguish ‘therapeutic cloning’ and its scientific goals from cloning with a procreative intention. However, even the question of what to call the cloning procedure and its product occupied an entire session of a Council meeting. Some argued that all human cloning is reproductive, and that when used for research, embryonic human lives are simply killed at an early stage of their development. Others claimed that the laboratory nature of the cloning procedure means that the entities produced should not be called embryos at all; "clonote" was suggested in place of the traditional term zygote. Arguments were made for "SCNT-construct," "embryoid blastocyst" or "pseudozygote" to distance the terminology from the natural human sentiments associated with the word embryo (3). In the end, we decided that the terminology should describe the nature of the procedure, it's purpose, and the entity produced, and agreed that ‘therapeutic cloning’ should be called ‘cloning-for-biomedical-research’ (CBR) and ‘reproductive cloning’ should be called ‘cloning-to-produce-children’.
Likewise, we explored the question of whether there was a compelling case for the importance of CBR, given the attendant moral dilemmas and social conflict, and whether other sources of cells might meet the same scientific and medical goals. Scientists at several sessions described hopeful progress in obtaining pluripotent cells (the functional equivalent of ESCs) from non-embryonic sources such as bone marrow and neural stem cells. Others explained projects to re-program or transdifferentiate adult cells as an alternative to any embryo-destructive research. Nonetheless, a strong case was made for the scientific and medical value of ESCs of specific patient genotypes to study genetic disease and possibly for immune compatible cell therapies.
However, questions were raised about reports of genetic instability and epigenetic errors in cloned ESC lines, and therefore about their potential usefulness for modeling disease, drug testing, and clinical application. Some cited the difficulty of emulating the spatio-temporal dynamics and complex microenvironments of natural embryogenesis in efforts to produce the specialized cells and tissues promised for cell therapies. They pointed to ongoing research in ectogenesis, and worried out loud about the temptation to gestate human embryonic clones to later stages for the procurement of more fully and properly differentiated cells, tissues, and even organ and limb primordia. Deep concerns were expressed in both scientific testimony and public comment about the commodification and commercialization of human eggs, the patenting of laboratory generated life, and the industrial scale production of embryos for cells or cytoplasmic growth factors.
In considering the social implications of stem cell research, the hopeful prospects of lifting the burden of disease and disability weighed heavily in the Council's considerations. But some questioned the practicality of creating customized cloned embryos to provide the promised personal repair kit for every needy individual. They criticized those who sought to persuade the politics by exciting expectations of cures for diabetes or Alzheimer's disease in a generation that was unlikely to be the beneficiary of this research. Likewise, they cited matters of social justice, the enormous economic cost of personalized medicine and the inequalities in distribution that would exacerbate a medical system already badly out of balance. They suggested that given these inevitable inequities, and the controversial and speculative nature of ESC research, that there should be a comprehensive ban on all forms of human cloning, a ban that would encompass both the public and private sector.
Others Council members, however, pointed to the social obligation of laying the foundations for the future, the imperative of healing and the trickle-down effect that often follows medical advances at first available only to the rich. They maintained that the ethical objections of some should not constrain the personal liberty of others, that even if we are not going to support this hopeful research with federal funding, that our nation has a long established legal foundation for freedom of choice in matters related to medicine and reproductive rights. In a society that permits the creation of excess embryos in IVF and allows abortion up to and beyond the end of the second trimester, it seemed to them a small leap of logic to extend this principle of private choice to the laboratory creation of cloned embryos for important medical goals. Others responded that by this principle there should equally well be a constitutional right to reproductive cloning.
Disentangling these many inter-related issues and balancing the competing principles proved more difficult than anticipated, but in the end, the Council agreed there should be a legal ban on reproductive cloning. Our concern was based on more than the likely medical dangers. We felt that cloning for reproductive purposes is something that touches (and would adversely alter) fundamental aspects of our humanity: issues of identity and individuality, the relationship between the generations, and the transformation of procreation into a process of manufacture. Our vote on this was unanimous.
However, CBR was a far more difficult matter, with so much at stake and so many competing goods to weigh. Of central concern was the embryo issue. All of the other considerations, including the troubling issues related to the use of human eggs, seemed to be more matters of prudent regulation than disagreements over fundamental principle. But with regard to the moral standing of the embryo, it was apparent that deep differences in basic assumptions were precluding social consensus. Yet it was not simply personal beliefs or different cultural traditions, nor was it simply lack of scientific understanding that was dividing the debate. It seemed clear that within the current frame of discussion we lacked conceptual tools and terms of understanding adequate to bring resolution. It was as though the conceptual revolution that opened such extraordinary avenues of advance in basic biology has now delivered dilemmas where its analytic and reductive assumptions and methodologies are inadequate to address.
To resolve the conflict concerning the human embryo, we needed to find a framework to explore the most fundamental questions concerning the very source of our moral standing and the ways human life is morally different from the other life forms that we use respectfully but instrumentally for human good. We had to ponder what potential capabilities and manifestations of form or function, endow a developing life with human value and inviolability. Similarly, we had to ask what lack of these qualities or capacities reduces a biologic entity to raw material, mere matter and information, to be instrumentally used for projects of the human will.
Ultimately, we recognized that more time was needed for a thorough and thoughtful consideration of the moral status of the human embryo. The Council as a group acknowledged that this is not simply an issue of balancing competing goods, but that fundamental principles are at stake that are not amenable to compromise or negotiated resolution. After extended deliberation, a majority of the Council felt that the wisest course of action for our nation was a four-year moratorium on CBR.
It is in the spirit of this continuing dialogue that I offer the following ethical analysis and practical extension of its principles in the search for a solution to our difficult national debate.