On August 9, 2001, President Bush, in his first major policy address to the nation, discussed what he described as "a complex and difficult issue, an issue that is one of the most profound of our time," the scientific and moral considerations in stem cell research.* He described the wide consultation and deep reflection that had gone into his consideration of the important yet competing goods at stake. And he announced that after several months of difficult deliberation he had decided that federal funds would be made available to support research with certain already extant ESC lines, but would not support research that would encourage any further destruction of human embryos. Some regarded this decision as a cynical political compromise while others saw it as a courageous acknowledgement of the important values on both sides on this difficult debate. Few, however, seemed to have understood either the historical foundations or the legal constraints within which this policy decision was made.
The issue of research on embryos and fetuses has been the subject of controversy and conflict for more than thirty years. With the advent of in vitro fertilization (IVF) in the late 1970s, the laboratory production of large numbers of human embryos became possible, and with them opportunities to study fertilization and early embryonic development. At the same time strong objections were raised that taxpayers dollars not be put toward specific sorts of research that violates the moral convictions and sensibilities of a large portion of the American public.
Over the next decade and a half a series of national commissions and advisory boards made various recommendations but funding was effectively blocked, first by a congressional moratorium and then by a de facto ban by the Department of Health, Education and Welfare. In 1994, the National Institutes of Health (NIH) convened the Human Embryo Research Panel that made two recommendations. First, they recommended federal funding for some forms of research using embryos left over from IVF procedures. And second, they concluded that, in some circumstances, federal funds should support the direct creation of human embryos with the explicit intention of using them for research purposes.
President Clinton overruled the panel on the latter point, but he did accept the panel's first recommendation and permitted the National Institutes of Health to consider applications for funding of research using embryos left over from IVF procedures. Congress, however, did not endorse this course of action. Toward the end of 1995, before any funding proposals had been approved by the National Institutes of Health, Congress attached language to the 1996 Departments of Labor, Health and Human Services (HHS), and Education, and Related Agencies Appropriations Act (the annual budget bill that funds the HHS and the National Institutes of Health) prohibiting the use of federal funds for any research that destroys, discards or seriously endangers human embryos, or that creates them for research purposes. This provision, known as the "Dickey Amendment" (2), has been attached to the HHS appropriations bill each year since 1996. Everything about the subsequent debate must be understood in the context of these legal restrictions.
The Dickey Amendment effectively prohibits the use of federal funds to support any research that endangers or destroys human embryos; it does not prohibit the conduct of such research using private funding. The amendment expresses the ethical conviction, as represented in the United States Congress, that nascent human life should be protected, not instrumentally used in scientific research, however promising that research may be. And, while not proscribing such research, it affirms that at the very least the destruction of human embryos should not be supported or encouraged by taxpayer dollars.
The first year after the Dickey Amendment took effect the cloning of Dolly was announced, and just two years later the isolation of human ESCs from IVF embryos was accomplished. These developments, with their promise of new avenues of progress in science and medicine, caused great excitement within and beyond the scientific community. There were new calls for federal funding of embryo research and specifically for the creation of tissue compatible sources of ESCs by "therapeutic cloning." However, most members of Congress did not change their position, and the Dickey Amendment has been re-enacted by a large majority every year since—most recently with a provision prohibiting federal funding for the creation of cloned embryos.
This seemed to close the question of the use of federal funds for human ESC research, but in 1999, the General Counsel of the HHS argued that the wording of the law might permit the use of federal funds for the study of ESCs lines if the actual destruction of the embryos from which they were obtained was done off-site and with private funds. Critics objected that such an interpretation was a technical loophole, consistent only with the letter but not the spirit of the law. President Clinton, however, accepted this approach and ordered that guidelines be drawn up for its implementation. But these guidelines were completed just before the end of the Clinton administration and were never put into practice.
When President Bush took office in January, 2001, these new regulations were put on hold pending review and the search for a way forward that would uphold the spirit (and not just the letter) of the Dickey amendment. The hope was expressed that, while continuing to withhold taxpayer support for the destruction of human embryos, some moral good might be drawn from the existing stem cell lines, given that the destructive acts that produced these lines could not now be undone. It was with this combination of concerns and intentions (and within the constraints of existing law) that, on August 9, 2001, the President announced the approval of federal funding of research using ESC lines created before the date of his announcement, estimated to be in the range of 60–70 lines. At the same time, acknowledging the serious ethical dilemmas across a range of issues raised by rapid advances in biotechnology, the President announced the establishment of the President's Council on Bioethics.