The Bush administration does not settle for half measures. On 7 November 2002, the US government dug in its heels and blocked a move from the United Nations, instigated by France and Germany, to ban reproductive cloning, insisting that the ban should also encompass the cloning of human embryos for medical research or therapy. On this emotional issue, the position of the US government is clear: in October, President Bush reclassified embryos and foetuses as “human subjects”, whose welfare deserves special attention. In common with the move made a few months earlier granting embryos prenatal coverage in health insurance, this statement is designed to remove the moral ambiguity from the status of embryos and assign to them the same rights as infants, children and adults.
With a Republican President and a Republican majority in Congress, US stem cell scientists fear that the future for their research looks bleak. Corbis
But not all US states are falling into line. In a controversial move last September, California passed a bill permitting scientists to use public funds to derive new cell lines from embryos for research. Flying in the face of President Bush's 9 August 2002 statement banning the production or derivation of any new embryonic stem (ES) cell lines after that date, the Californian law will take effect on 1 January 2003. Known as the Ortiz bill after its sponsor, Senator Deborah Ortiz, the new law bans reproductive cloning but, significantly, allows therapeutic cloning. This clash between federal and state policy is indicative of the current divisions in the USA regarding the future of stem cell research.
Ortiz and California's Governor Gray Davis hope that the new legislation will prevent further ‘brain drain’ and attract researchers to California; two years ago, Roger Pedersen left the University of California in San Francisco for the more hospitable political environment of the UK, leaving behind the political vicissitudes that continue to plague stem cell scientists in the US. The mid‐term elections in November 2002 resulted in a Republican majority in Congress, making more chaos in US stem cell policy seem likely as many in that party continue to link ES research to the hot button of abortion. Add to this the downturn in financing for biotech companies and the future is not bright for US stem cell researchers.
“I am not as concerned about where the science will go as about where we will be permitted to go.”
Light micrograph of a mouse blastocyst produced by nuclear transfer being held by a pipette to remove stem cells. Photographed at the Centre for Genome Research at Edinburgh University, Scotland. King‐Holmes, Science Photo Library
About 250 scientists gathered at the symposium to hear about the developments in ES cell science, the ethical implications and the political furore the research has engendered in the four years since the publication of John Gearhart's work and the parallel research of James Thomson at the University of Wisconsin in Madison. Not surprisingly, a great deal of time was devoted to discussing the ethical questions researchers face, public opinion and the choppy political seas surrounding this research in America. In opening and closing the symposium, Gearhart stressed that although scientific progress is steady, the distance that needs to be crossed before stem cell research can be translated into therapies is quite significant, and it is imperative for researchers and the media not to promise the public any quick fixes. “But I am not as concerned about where the science will go, as about where we will be permitted to go,” he said. Gearhart admitted that he was worried about the future of the work in the USA. Although the new California legislation is a positive move, Gearhart and others are uneasy and sceptical that state endorsement of stem cell research is a long term solution. “I'd prefer to see the legislation enacted at a uniform, federal level, rather than leaving it up to individual states,” Gearhart said. “And besides, it's the Feds (that is, the federally‐funded National Institutes of Health) that have the money (for research).”
In the political arena, the debate tends to take an ‘all or nothing’ tone
Few scientific issues have captured the attention of the American public as much as stem cells. “This area of science resonates with the public, and that adds a great deal of scientific and political pressure,” said Gearhart. To deal with the ethical questions raised by their research, ICE is working with the Johns Hopkins University's Phoebe Berman Institute for Bioethics to address safety issues and other problems, such as access to cell therapies developed and issues relating to the creation of chimeras, said Ruth Faden, professor of biomedical ethics and executive director of the Berman Institute.
From a broader perspective, it is the disputed moral status of embryos — most notably excess embryos created through in vitro fertilization (IVF) — that is the linchpin issue in the US debate, which pits right‐to‐life advocates against patients and families, according to Thomas Murray, president of the Hastings Center, a bioethics think‐tank in Garrison, New York. Rather than representing a true compromise between liberals and conservatives, Bush's August 2002 policy, limiting human ES work to an alleged 64 cell lines created before that date, pleased no one, solved nothing, and is fraught with serious problems, he added. First, few believe that there are as many cell lines as 64. Second, safety issues for those extant lines are significant, centring on the fact that all have been grown on mouse feeder layers and may be infected with murine viruses. Third, it is unlikely that there are sufficient human leukocyte antigen (HLA) types represented in available cell lines to perform meaningful research on stem cell transplantation. Finally, there are logical problems with the decision. “If it is ethical to use stem cell lines in existence before 9 August, why would it be any the less ethical to use unwanted frozen embryos which were frozen prior to 9 August to obtain stem cells?” asked University of Pennsylvania bioethicist Arthur Caplan. “In reality, the President's policy amounts to a ban on embryonic stem cell research,” he wrote in the Penn Bioethics newsletter last September.
Bringing some historical perspective to the forum, Norman Fost, professor of paediatrics and medical ethics at the University of Wisconsin, described his institution's experience of bringing Thomson's ES research through the university review process before it was published in November 1998. Thomson started informal discussions with the university in 1994, about a year before bringing the work to the Human Subjects Committee, although strictly speaking, research with ES cells does not fall under the rubric of human subject research, Fost said. In 1998, the school established a Bioethics Advisory Committee, which has met about 17 times to voluntarily bring its privately funded research into compliance with federal guidelines. “In our case, science did not precede ethics, although we didn't get it all right on the first round,” Fost observed. One ethical issue the committee did not anticipate, for instance, was the mixing of human and animal tissue in research, which led to subsequent consultations with developmental biologists. Citing this example, Fost noted that there is a need for heightened scrutiny.
But in the political arena, the national stem cell debate tends to take an ‘all or nothing’ tone, observed Murray. The problem is that since Thomson and Gearhart published their landmark research, stem cell policy in the US has been stymied and stalled by the two diametrically opposed presidential adminstrations. “How do you build a research base if you don't know from president to president what the policy will be?” asked Gearhart. The work of the National Bioethics Advisory Committee (NBAC) “which had been laboring in happy obscurity till Dolly,” noted Murray, a former NBAC member, is now being dismantled as the committee itself was dismantled by President Bush after he took office. It was replaced by the new Council on Bioethics headed by the conservative Leon Kass who succeeded Harold Shapiro, former president of Princeton University, New Jersey, an economist and healthcare policy expert. Kass, a scientist and bioethicist, opposes human ES research and cloning, which, he believes, reflects “the wisdom of repugnance”, a common‐sense repulsion towards ES research, cloning and even IVF.
It is scientists who must ultimately decide on the ethical use of their innovations
But Kass’ opposition has drawn great fire from the scientific community, citizens in the liberal camp, and even Republicans, including Senator Orrin Hatch from Utah and former first lady Nancy Reagan. Jerome Groopman, an oncologist has repudiated Kass’ views in several articles, asserting that only “real scientific truth” has a place in the national debate as a guide for ethical decision making in science, not subjective emotional reactions. But public reservations that echo Kass’ conservative stance raised a ‘red flag’ in Wisconsin's discussions of Thomson's research and have important weight in the US, whether from a religious or secular point of view, said Fost. However, in the University of Wisconsin's experience, such a fear of sliding down a slippery slope from embryo research and therapeutic cloning to reproductive cloning was not a sufficient moral argument to restrict human ES research, Fost noted.
Elaborating on Fost's comments, Shapiro stressed that it is scientists who must ultimately decide on the ethical use of their innovations. “Ethical issues will always accompany science,” he said, adding that making public policy on such charged issues in a liberal democracy is by definition fraught with difficulties. First, there is the right of the individual to pursue his or her own life, goals and, in the case of a scientist, his or her chosen research direction. “But in such a society of moral pluralism, where citizens are free to follow their own conscience, no one can occupy the moral high ground alone,” Shapiro stated. The task of a liberal democracy is to use the political framework to bind citizens with differing beliefs together. The government clearly has a legitimate right to act in the ES cell area, but how does one set public policy that is based on the majority but respects other beliefs about such sensitive issues? While polls indicate that the majority of US citizens support ES research, the concerns of the minority, whose consciences are deeply offended due to a belief that the embryo has a moral status equal to any other person, must also be taken into account. Add this to changing political winds, and the present situation in the USA is the result. “We have never found a ground of discussion on these issues, unlike the UK,” said Shapiro.
Another problem unique to the USA in developing a cogent public policy for stem cell and cloning research is the impact commercial and market incentives have in biomedical research, said Shapiro. “Market solutions don't necessarily lead to just solutions,” he observed. Both Fost and Shapiro expressed optimism for the future, however, citing the historical US opposition to IVF. Some were opposed on the basis of fear of the unknown, and some on the basis of moral repulsion. Within a quarter century of the first IVF birth, public opinion has changed radically. Fost and Shapiro believe that, over time, public opinion on stem cell research and cloning will follow a similar trajectory as the benefits become apparent. No doubt all those at ICE would like to believe that, too.
- Copyright © 2003 European Molecular Biology Organization