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President Bush’s recent decision to allow federal funding for embryonic stem cell research is drawing mixed reviews from scientists and bioethicists across the country. Some approve of his permitting the research under more limited circumstances than the Clinton administration, while others predict the new guidelines will effectively end such research.
"This is basically just shutting it down," says Gregory Pence, PhD, a bioethicist and professor of arts and humanities at the University of Alabama-Birmingham. "It is only going to be approved in a very limited number of stem cell lines."
Federal law prohibits the use of federal funds to support research involving the destruction of human embryos, and harvesting embryonic stem cells necessitates the destruction of the embryo. However, in 1999, the U.S. Department of Health and Human Services announced an interpretation of the law that allowed federal funds to be used to research stem cells as long as researchers worked only with stem cells themselves (not embryos) and could document that no federal funds were used to actually derive the cells. The National Institutes of Health developed guidelines for researchers interested in submitting proposals, but the process was put on hold with the change in administration.
Last month, the president announced he would permit the funding, but only to support research using any of the estimated 60 cell lines already in existence worldwide and, of those, only the lines that researchers could verify were developed from embryos leftover from infertility treatments and not those created specifically for research purposes could be used.
Bush also announced the creation of a new Council on Bioethics, to be chaired by University of Chicago bioethicist Leon Kass, MD, PhD, which will evaluate stem cell research proposals. Kass is a well-known opponent of abortion, cloning, in-vitro fertilization, and has criticized embryonic stem cell research in print, Pence notes.
Although the new restrictions may slow the process of embryonic stem cell research, that may not necessarily be a bad thing, says Stuart Newman, PhD, professor of cell biology and anatomy at New York Medical College in Valhalla and a founding member of the Cambridge, MA-based Council for Responsible Genetics. Newman is not opposed to research involving stem cells taken from embryos produced through infertility treatments, but does oppose the creation of embryos solely for research purposes.
"I don’t believe we should go prematurely into human experimentation," he says. "It is striking to me that researchers have been working on stem cells in mice for 20 years and they haven’t made that much progress. Maybe they just need to work on mice for awhile."
Where you stand on the ethics of stem cell research largely depends on whether you feel that human embryos are equal with human beings, or whether you feel they are just a group of cells, says Maxwell J. Mehlman, JD, professor of biomedical ethics and the law at the Center for Biomedical Ethics at Case Western Reserve University in Cleveland. "My own opinion is not quite either — that they [embryos] are a form of potential human life, even though they aren’t human beings," he says. "Therefore, they should be accorded a certain amount of respect."
Ethically, one should also consider the potential benefits to existing people that medical advances from stem cell research could provide, he adds. Where he has a problem with the current debate on stem cell research, he says, is the relative lack of attention to the number of embryos that end up being discarded through in-vitro fertilization (IVF) procedures. "If we truly feel that destruction of human embryos is equal to the destruction of human beings, then maybe we should re-examine IVF, although I don’t see that happening," he says.
Although Bush said his administration would permit research into 60 existing embryonic stem cell lines, many scientists questioned whether there were even that many available. The administration claims it has documentation for 60 lines worldwide, though it does not know how many of these lines will meet the administration’s criteria. In addition, there are concerns by researchers that some of the lines will not be of sufficient quality to study.
And, an article in the Aug. 13 Wall Street Journal (WSJ)1 raises concerns that cell lines developed with private funding are covered by patent protections, which will further hinder some researchers in obtaining cells to work with. According to the article, the Wisconsin Alumni Research Foundation (WARF), a for-profit affiliate of the University of Wisconsin, owns the fundamental patent governing all embryonic stem cells, regardless of which cell line they come from. Researchers at the University of Wisconsin originally discovered the potential of embryonic stem cells to eventually form any kind of human tissue.
"No matter how you derive a stem cell line, WARF has the right to block you from using it," Arti Rai, a University of Pennsylvania patent lawyer told the WSJ.
In fact, the foundation filed suit in August in U.S. District Court in Madison, WI, against Menlo Park, CA-based Geron Corp., claiming that Geron had tried to stop WARF from working with other researchers. Geron has a licensing agreement with WARF that gives it the commercial rights to certain cell types grown from the five stem cell lines developed by the university. Both parties have since announced plans to settle the dispute out of court.
A key concern about restricting federal funding of genetic research is that, typically, research in the private sector occurs without accompanying federal oversight — the accompanying stricter rules governing research protocols and informed consent requirements, says Mehlman. "And the goal of publicly funded research is to achieve benefits for the society at large," he adds.
If stem cell research is left largely up to the private sector, which develops innovated diagnostic and treatment options for disease, will those benefits be reserved only for the wealthy? Private companies who invest significant time and money in stem cell research to develop medical tests and treatments will want to make their products available for whatever the market will bear, Mehlman says, which will probably be a considerable amount. "Part of the benefit of public research is to secure the benefits of the research for everyone," he says.
1. Regalado A, Carroll J, Johannes L. What access will researchers have to the 60 existing stem cell lines? Wall Street Journal Aug. 13, 2001.
• Gregory Pence, University of Alabama-Birmingham, Humanities Building, HB 420, Birmingham, AL 31260.
• Maxwell Mehlman, CWRU School of Medicine, 10900 Euclid Ave., Cleveland, Ohio 44106-4976.
• Stuart Newman, Basic Science Building, New York Medical College, Valhalla, NY 10595.
We’d like to know if President Bush’s compromise on stem cell research will impact current medical research programs at your facility. Will restrictions on the use of existing stem cell lines mean changes or eliminations to planned research or programs already in place?
Let us know how your hospital is affected. Send your comments to Kevin New, managing editor, Medical Ethics Advisor, P.O. Box 740036, Atlanta, GA 30374. E-mail: firstname.lastname@example.org.