Out of One, Many: Stem Cells Ignite Scientific Inquiry, Controversy in '99
But while the scientific understanding of stem cells and their potential has become much clearer, things on the political and ethical fronts are still murky. It seems that every time the issue of research using human embryonic cells is raised in the media, entire forests are felled to provide fax paper for outraged abortion foes and passionate research supporters. And whenever the subject comes up for discussion before Congress, the air temperature on Capitol Hill rises a few dozen degrees.
In December 1998, NIH Director Harold Varmus, MD, told a Senate appropriations subcommittee that the ability to control cell specialization would be "an unprecedented scientific breakthrough with the potential to revolutionize the practice of medicine and improve the quality and length of life." But speaking in opposition to stem cell research, Richard Doerflinger of the NCCB told the committee that "Even a good end does not justify an evil means." He recalled the specters of the Tuskegee syphilis study and Cold War-era radiation experiments as examples of good science gone bad.
Undaunted, Varmus told the NBAC in January of '99 that funding for the research could begin later in the year, thanks to a legal ruling from HHS, which held that since stem cells derived from human embryos are not themselves organisms, research that uses the cells is not covered by the federal ban on human embryo research. Federal research that generates and uses stem cells from nonliving fetuses can also be supported, the HHS ruling holds, although not research involving in vitro-fertilized fetuses. A ban on human cloning imposed by President Clinton would apply only to stem cell research used for cloning, HHS said.
It didn't help to clarify the situation when the American Association for the Advancement of Science (AAAS) broke ranks with NBAC and announced preliminary support for federal funding of stem cell research, but did not recommend funding the derivation of cells from human embryos.
In December 1999, the NIH issued a draft version of research guidelines stating that stem cell research would be funded by NIH only if the cells were already removed from the embryos, or removed from fetuses under existing federal guidelines. The guidelines also require that cells in NIH-funded research be derived only from embryos that were "in excess of clinical need" at fertility clinics, and that the donors of the embryos must give fully informed consent to the ultimate use of the embryos.
Additionally, the guidelines call for establishment of a Human Pluripotent Stem Cell Review Group to assure that the rules are followed, excluding from federal funding any research linked to human cloning, excluding research involving adding stem cells to human or animal eggs or embryos, and excluding funding for research using human embryonic stem cells extracted from embryos that were created expressly for research. In effect, all embryos that produce the stem cells must have been discarded by fertility clinics and not created in the laboratory.