Bush turns amber on stem cell research

In a short speech aired on national television on August 9, US President George W. Bush announced that the National Institutes of Health (NIH) will be allowed to fund work with human embryonic stem (ES) cell lines — but only if the work involves lines that were established before the president’s announcement. The decision was greeted with measured optimism by many scientists, who await further details about the existing ES cell lines and the process for obtaining them. Bush’s decision will replace guidelines crafted under the Clinton administration, which never went into effect. They did not permit the use of federal funds to destroy human embryos but would have allowed federally funded scientists to carry out studies involving ES cells obtained from privately funded researchers who had derived the cells from surplus embryos to be discarded by fertility clinics. The new rules are more restrictive in that federal funding will be permitted only for research on cell lines that are already established. Stem cell lines derived after 9 August will not be available for funding, according to an NIH spokesperson. In his speech, President Bush said he had concluded to allow federal funds to be used for research on the existing ES cell lines “where the life and death decision has already been made.” According to Bush, there are 60 ES cell lines in existence today. The number came as a surprise to most scientists working in the field, many of whom are skeptical. “No one I know is clear where the number of 60 cell lines comes from. It is certainly not true that there are 60 completely validated lines out there,” says Janet Rossant of the University of Toronto, Canada. An NIH spokesperson explained that the NIH located the 60 plus stem lines when staff carried out a telephone survey of researchers and companies in the US and abroad. Just a month earlier, an NIH report on stem cells estimated that only about 30 human ES cell lines existed. The US biotech company Geron has reported having 5 ES cell lines, 3 of which have been extensively characterized. In a press conference held the day after the President Bush address, Geron president and CEO, Thomas Okarma, said that because of the nature of stem cells — they can replicate indefinitely — a limited number would probably satisfy the needs of the research community for now. At present, there is no way of knowing how well characterized the 60 cell lines identified by NIH are and how viable they will turn out to be. The NIH is now in the process of creating a ES cell lines registry. A concern expressed by some scientists is that many ES cell lines may have commercial strings attached that could limit research. Even if 60 viable cell lines do exist, the number will not be sufficient for any therapeutic applications. According to Geron’s senior vice president, David Greenwood, when cell therapies become available “we will want to target patient populations as precisely as we can. When that day comes we will want to use multiple cell lines.” Despite these concerns and uncertainties, many scientists were relieved that Bush did not altogether ban stem cell research. The issue is likely to be disputed further once Congress reconvenes in September and it is possible that Bush’s decision will be overruled. Republican senator, Arlen Specter, introduced a bill that would allow NIH to fund derivation of new ES cell lines, and a companion bill has been introduced in the House of Representatives. In a press release Specter said “more than 60 stem cell lines are necessary for scientific research to be done now and certainly what will be required in the future.” In his August 9 speech, Bush also announced the creation of a council on bioethics to be chaired by Leon Kass, an expert in biomedical ethics and a professor at the University of Chicago. The purpose of the new council will be ‘to monitor stem cell research, to recommend appropriate guidelines and regulations and to consider all of the medical and ethical ramifications of biomedical innovation.’