Tuesday, August 14, 2001
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Bush's Stem-Cell Decision May Have Unexpected -- and Unintended -- ConsequencesBy R. ALTA CHARO
Last week, President Bush announced that he would permit the use of federal funds to support limited research on human embryonic stem cells. He will require researchers to use only cells collected from embryos created for reproductive -- rather than research -- purposes, and donated without compensation and with informed consent. Most important, the embryos must have been destroyed before the president's announcement. His goal was to eliminate not only the remote possibility that future decisions to discard embryos might be influenced by the prospect of federal support for research on stem cells derived from them, but even the appearance that such influence might exist. The president said that approximately 60 lines of the cells existed worldwide at the time of his announcement. Administration officials announced on Sunday that, regardless of the scientific results of the work with existing lines, the government would not support research on other lines in the future. Many scientists -- especially those who believe that fewer than 60 lines exist -- fear that the existing lines either may not be capable of producing all other kinds of cells or may not be robust and diverse enough to support their work. Nonetheless, a number of scientists have expressed relief that at least some funds will be available. One of the most significant aspects of the president's announcement for researchers, and yet one of the least discussed, is its potential to decentralize stem-cell research in the United States. Prior to his decision, scientists were uncertain about how the Bush administration would interpret Congressional actions since 1996 that prohibit the use of federal funds for research that involve the destruction of embryos. Congress never specifically prohibited spending money to study cells from embryos that had been destroyed using private funds. Nonetheless, that uncertainty had an effect on early research on human embryonic stem cells. Scientists worried that the administration might decide that, because of shared overhead costs, conducting research on embryonic stem cells with private money in a facility that also houses federally financed research constitutes a use of federal dollars. To avoid that possibility, the University of Wisconsin at Madison, for example, helped James A. Thomson to develop a separate research facility for his work that led to the creation of the first sustainable line of human embryonic stem cells. The sizable investment required to create separate laboratories presented an obstacle to other universities that might have been pleased to see their scientists accept private funds for embryonic-stem-cell research. With last week's announcement, however, comes the possibility of removing that uncertainty. Depending on how the National Institutes of Health interprets the president's policy and how it interprets the significance of shared overhead, the result may be a blossoming of privately supported research on campuses that no longer need to consider the development of separate facilities as part of the start-up costs for the work. Ironically, in setting a policy that is more conservative than that of the Clinton administration, President Bush has expanded -- slightly -- the area of research eligible for federal funds. After the Clinton administration removed the regulatory obstacles that had created a de facto moratorium on federal support of research on embryos, the N.I.H. appointed a Human Embryo Research Panel to recommend guidelines for its grants. That panel recommended spending federal money on research on discarded, surplus embryos and on a carefully delimited range of experiments that would require the use of so-called research embryos -- that is, embryos created specifically for research. The Clinton administration announced its opposition to the latter recommendation, but before the N.I.H. could act on the remaining recommendations, Congress enacted a series of legislative prohibitions on the use of federal money for research that destroyed embryos, and the panel's recommendations became moot. Partly in response to a report by the National Bioethics Advisory Commission urging the removal of those legislative obstacles, the N.I.H. issued guidelines for research on human embryos that detailed the permissible uses of embryos, the consent process, and what documentation would be needed. Those guidelines included a requirement that the cell lines be derived from embryos that had been frozen prior to being discarded, in order to ensure that they were not needed for reproductive purposes and that they had been given to researchers after the donors had some period of time for reflection. President Bush was forced to avoid endorsing that requirement, lest an inordinate number of the existing cell lines turn out to be ineligible because they had been derived from fresh, rather than frozen, embryos. To that extent, the new policy retreats from the most conservative view of informed consent for donation. It is not yet clear whether other aspects of the N.I.H. guidelines will remain in effect. In particular, the guidelines cover work on stem cells derived from tissue taken from aborted fetuses, such as that done by John D. Gearhart of the Johns Hopkins University, who has used such tissue to derive cells that may, like embryonic stem cells, be able to produce all kinds of organs. That area of research has remained eligible for federal funds since 1992, despite Congressional bans on embryo research, but the Bush administration may develop new rules concerning it. The president has said that he opposes federal support for such research, but the N.I.H. appears to be including stem-cell lines derived from aborted fetuses in its estimated 60 eligible lines. If that is true, it raises some questions about the continued eligibility of other fetal-tissue research for federal funds. It should be noted that some scientists have expressed concern that the president's policy will force researchers to rely solely on patented stem-cell lines -- and to pay licensing fees. Such concerns are misplaced. First, the basic patents cover lines already in existence and those to be developed, so whether a researcher wishes to use federal money and study existing lines or to use private funds and study future lines, the issues concerning patents remain the same. Second, patent holders like the University of Wisconsin have already made arrangements to ensure wide access to the lines, including very low licensing fees for academic researchers, and to ensure that researchers can freely share -- and even patent -- their own discoveries made through stem cells. In a development related to stem-cell research, scientists were dismayed when the House of Representatives recently passed a bill banning human cloning. The bill includes a provision that would make it a crime to use cloning technology to make embryos for research purposes. Legislators have chosen to ignore both the fact that it would be possible to use other means to prevent the birth of children conceived through cloning -- for instance, prohibiting the transfer of a cloned embryo into a woman's body -- and the long history of creating embryos through in vitro fertilization for research on how to improve infertility treatments. It is interesting to note that, to date, Congress has yet to comprehensively regulate medical experiments on children or adults -- let alone make any aspects of them a crime. Instead, the government relies on conditions attached to the receipt of federal funds for research or approval by the Food and Drug Administration of resulting products, as well as a system of voluntary compliance with federal standards by large research institutions even where federal funds or F.D.A. approval are not at issue. But research supported by private funds that is not covered by those regulations can be conducted without fear of federal penalty, although state laws and the rules of professional societies may restrict it. The National Bioethics Advisory Commission has called for federal legislation in that area, and bills to regulate such research have been recently introduced in Congress. So far, however, human research generally remains untouched by federal law. If the House's bill on cloning becomes law, it would create significant federal limits on what some scientists consider to be an important and promising area of research before federal protections have been enacted to regulate research on people generally. The furor over embryonic-stem-cell research in general, and research on cloning in particular, puts one in mind of earlier conflicts between the needs of science and the sanctity of the body -- dead, alive, or yet to be conceived. Although physicians in ancient Greece were permitted to dissect the bodies of foreigners, dissection of Greeks was unthinkable. Indeed, for most of the medieval era in Europe, dissections were forbidden because of the church's view that the human body was God's province. It wasn't until the 13th century that strictly limited and controlled dissection was permitted at universities, and even then the practice continued to represent an uneasy truce between cultural taboos and scientific advances. Each era debates the limits of what can be done to the human body and reaches its own conclusions. And in every era, some scientist feels compelled to test those limits in the name of seeking knowledge. In our own era, that debate will continue under the auspices of yet another federal body set up to consider the perils and potentials of biomedical advances -- the President's Council on Bioethics, which Mr. Bush announced last week. Its chairman, Leon R. Kass of the University of Chicago, has said that its mandate will go beyond merely monitoring stem-cell research and will extend to a comprehensive public discussion of how to embrace the promise of biomedical advances without losing sight of "human decency, human dignity, and respect for life." Researchers can breathe a little easier, knowing that the door has opened a crack for work on one of the most promising areas of medical research today. But they would be foolish to rest easy. Attempts to place limits on research are not new, and they are likely to become more intense. R. Alta Charo is a professor of law and bioethics at the University of Wisconsin at Madison.
Background articles from The Chronicle:
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 Education Dept. may relax provision denying student aid to those with drug convictions University of Florida expects a decrease in black enrollment this fall Yale plays up abolitionist history and ignores its ties to slave trade, graduate students say OPINION: Bush's stem-cell decision may have unexpected -- and unintended -- consequences Majority of Ireland's medical students are from outside of Europe Cal State system throws its weight around in negotiating an e-book deal A digest of recent corporate news in distance education |
Copyright © 2001 by The Chronicle of Higher Education