On the Brink

Click to view the PDF file: Important Events in Stem Cell Research Graphic: Leza Berardone As the Bush administration stood on the verge this month of announcing a decision on whether the federal government will fund embryonic stem cell (ESC) research, the scientists involved braced themselves for the worst and continued planning for ways to move ahead. An issue that is politically, ethically, and religiously loaded, this tempest, like the issues of RU-486 and abortion before it, has galvanized special interest groups with furious intensity. But unlike the so-called morning-after pill or the legalization of abortion, a thumb's down decision could leave research in a state of flux, with scientists seeking more private funding, either here or abroad, or turning to other types of stem cell research (see "Cultivating Policy from Cell Types"). Conservative policymakers welcome this alternate line of investigation. They continue to point out that recent advances in adult stem cell research could make embryonic advances superfluous. "There are a lot of new studies about sources from adult stem cells, from human fat cells, and placenta," says Tommy Thompson, secretary of Health and Human Services (HHS), "It's not just embryonic cells" that may provide stem cell lines for research. A decision, he says, could be reached as soon as next week. A meeting slated for April 25 to review submitted proposals was quietly and indefinitely postponed. The administration's presumed position makes no sense to many scientists, including 80 Nobel laureates and 115 college and university leaders who have lobbied, via position papers, for federal funds to allow embryonic research to begin. The plasticity of these cells, as compared to those derived from other sources, is preferable. "For the [United States] not to fund this research will lead to an exodus of talent to other countries and will eventually hurt our biotech and pharmaceutical industries, with potentially disastrous consequences," said William R. Brody, president of Johns Hopkins University, in a written statement. At the American Association for the Advancement of Science, members are already preparing a response to a possible ban, says Mark Frankel, director of the AAAS Scientific Freedom, Responsibility, and Law Program (www.aaas.org/spp/dspp/sfrl/sfrl.htm). Frankel was one of the authors of an AAAS letter, sent to President George W. Bush, which supports federal funding. "We'll be prepared to act when the Bush administration announces the results of its review," he says, anticipating that a ban is more than plausible. "I think it's highly unlikely that the Bush administration will allow the NIH policy to go forward," he says. "I think they will find a basis for denying that, I think they will see it in the legal arguments that the Clinton administration used." There's mixed sentiment regarding how such a ban would affect the business of researching embryonic stem cells. Some, like developmental biologist James Thomson of the University of Wisconsin and lead investigator in one of two seminal pieces on stem cell research, think the "huge difference is that most NIH-funded scientists... would be essentially excluded from doing this type of research." It belongs in the public domain, he says. (Geron Corp. of Menlo Park, Calif., funded Thomson's work, and much of the work of the other lead investigator, John Gearhart, an obstetrics and gynecology professor at Johns Hopkins.) "We will go after private donors and private foundations and things like that, but they cover a very small percentage of research in the United States," Thomson says. "The field will clearly not go forward as fast as it would if it were publicly funded." At Layton BioScience in Sunnyvale, Calif., CEO and founder Gary Snable says he thinks science will find a way to make the issue moot. "If you can learn how to immortalize and expand this precious tissue to unlimited quantities, then I think the political part will go away." Besides, he says, numerous private companies are around to "pick up the slack." Layton is a private company that is working with neuronal cells in hopes of restoring the function in chronic stroke patients. These adult cells weren't necessarily chosen because they lack the controversy surrounding fetal and embryonic cells, he acknowledges, but it does "eliminate one potential problem." The Genesis of a Controversy This dilemma began three years ago, when Thomson and Gearhart, working independently, isolated human pluripotent stem cells. Thomson used donated cells taken from embryos grown in vitro; Gearhart's came from primordial germ cells obtained from aborted fetal tissue. It is the ways in which these cells were derived that is causing the turmoil. In general, critics contend that a human embryo has the moral status of a person from the moment of conception. Any activity that harms or destroys the embryo, including isolating stem cell lines, therefore destroys human life. In January 1999, Harriet S. Rabb, the Clinton administration's HHS general counsel, announced that because human pluripotent cells are not in themselves embryos, federal law did not prohibit NIH funds from being used for research using those cells. "The statutory prohibition on the use of funds for human embryo research would not apply to research utilizing human pluripotent stem cells because such cells are not a human embryo within the statutory definition," Rabb wrote. "Pluripotent stem cells are not organisms and do not have the capacity to develop into an organism that could perform all the life functions of a human being." President Bill Clinton requested a report on human ESCs from the National Bioethics Advisory Commission (NBAC), which suggested guidelines for using and deriving human ESCs, calling it a "mistaken notion" and a "misrepresentation" to try and separate research using ESCs from how those cells were obtained. The NIH modified these guidelines: The federal government would fund the research, but not ESC derivation. In August 2000, NIH finalized its guidelines. This had been the first time that such funding would have been allowed. Under the NIH guidelines, researchers, following strict conditions, could get ESCs from privately funded scientists who had destroyed the embryos. They also needed certification that the cells were derived by in vitro fertilization for fertility treatment and voluntarily donated. The new regulations struck a chord with the opposition. "What some NIH officials call the 'separation' between 'derivation and use' (that is, between destroying a human life and using the fruits of that destruction) is merely creative bookkeeping," charges Richard M. Doerflinger, secretariat for pro-life activities of the National Conference of Catholic Bishops. Critics contend the NIH regulations still violate the Dickey Amendment, a rider attached to NIH appropriation bills for several years that bans federally funded research in which human embryos are destroyed. All bets were off again when Bush was sworn in as president. Shortly after his inauguration, Bush told reporters, "I believe there's some wonderful opportunities for adult stem cell research ... . But I do not support research from aborted fetuses." While denying abortion opponents and social conservatives their fervent wish that he ban federal research involving fetal tissue or stem cells derived from induced abortions, he did order a review of the NIH guidelines. His action suspended all RFA (request for application) submissions. Only three had been submitted, and one has been withdrawn. The other two are awaiting review. Those on Capitol Hill haven't stayed out of the fray. In April, Senators Arlen Specter (R-Pa.) and Tom Harkin (D-Iowa), chairman and ranking minority member, respectively, of the Senate Appropriation Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, reintroduced their bill, S. 723, the "Stem Cell Research Act of 2001." They first presented the legislation in January 2000. "We have a duty to accelerate medical research by allowing researchers to utilize federal funds to derive their own stem cells," said Specter in introducing the legislation. The bill asks for funding of both use and derivation. Both Specter and Harkin emphasized in their floor addresses that, "as it stands today, embryonic stem cell research in the private sector is not subject to federal monitoring or ethical requirements." Judie Brown, president of the American Life League, condemned the Specter/Harkin legislation because it "essentially regards embryonic children as mere material--garbage or trash--not persons." No Predicting the Future On April 25 HHS officials postponed the planned first meeting of the Human Pluripotent Stem Cell Review Group, a working group of the NIH Center for Scientific Review Advisory Council. Its intent was to evaluate stem cell research protocols for compliance with the agency's ethical policy guidelines, a new and essential hurdle in the funding process. The Justice Department and the HHS' general counsel are looking at the legal and ethical assessments. Scientific and medical assessments also are being conducted. But just who is conducting the various reviews is unknown--HHS officials are remaining tight-lipped about who is involved. One knowledgeable source says that a "mixture" of political and career employees are conducting the reviews. According to NBAC executive director Eric Meslin, the Bush administration has not asked his commission for its input. Currently, Martin Pera, of Monash University in Melbourne, Australia, and Thomson and Gearhart are developing mechanisms for collaborating with colleagues worldwide as research in other countries continues unabated by the U.S. reviews. Commercial endeavors are accelerating as well. In March the U.S. Patent and Trademark Office issued a broad patent covering stem cells to the WiCell Institute, a nonprofit organization established at the University of Wisconsin to pursue stem cell research without federal support. As with the abortion issue, which has never died down, the issue of publicly funded stem cell research will probably not go away, regardless of what President Bush does. Hurdles continue to be put up. A May 4 federal court decision, acting on a class-action suit filed primarily by pro-life advocates and social conservatives, has delayed any research funding until the Bush administration makes a decision. The AAAS' Frankel foresees further congressional involvement and a lawsuit, which "could delay things for years .... Then I think it has at least a 50-50 chance of some embryonic stem cell research of being approved." But, he points out, no one knows just how any of this will turn out. Ted Agres (tagres@usa.net) is a freelance writer in Washington, D.C. A Stem Cell Primer Human stem cells can be derived from the following sources: Human fetal tissue following elective abortion (EG cells) Human embryos that are created by in vitro fertilization (IVF) and that are no longer need by couples being treated for infertility (ES cells) Human embryos that are created by IVF with gametes donated for the sole purpose of providing research materials (ES cells) Potentially, human (or hybrid) embryos generated asexually by somatic cell nuclear transfer of similar cloning techniques in which the nucleus of an adult human cell is introduced into an enucleated human or animal ovum (ES cells) --Ted Agres

On the Brink

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