In his Aug. 9 speech on embryonic stem cells, President Bush announced the creation of a new Council on Bioethics, chaired by University of Chicago professor Leon Kass, M.D., Ph.D., that will provide guidance on stem cell research and other biotechnology issues.
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What will be NBACs legacy, and how will the changing of the bioethics guard affect scientists, patients, and research participants?
A quarter-century history of national bioethics panels indicates that these groups can spur reform in scientific practice through both policy change and informal influence. But it also shows how politics can frustrate and even derail their efforts.
The National Research Act of 1974 created the first such panel, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In contrast to later commissions, its recommendations were directly adopted as federal regulations after approval by the Secretary of Health, Education, and Welfare. This group formulated the so-called Common Rule, a set of uniform guidelines for all federal agencies that perform and fund research on humans. The commissions principles are summarized in the Belmont Report of 1979.
In 1978, the Presidents Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research began its work under President Carter and continued for 2 years into the Reagan Administration. End-of-life decisions were a primary concern for this group, and "they finally got all the parties together and got the country to agree on a uniform definition of brain death," recalled George Annas, J.D., chair of the health law department at the Boston University School of Public Health. In addition to its landmark 1981 report, Defining Death, the commission issued several reports on human subject protections and was the first group to take on the ethics of genetic research, genetic counseling, research whistleblowing, and health care access.
The Biomedical Ethics Advisory Committee, initiated in 1988, was a victim of the political divide over abortion. "We werent even going to talk about abortion," but instead were slated to discuss issues raised by the new genetic technologies, said BEAC chair Alexander Capron, LL.B., professor of law and medicine at the University of Southern California in Los Angeles. "The problem was that we were reporting to a congressional board that was riven by partisan politics."
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Capron, who earlier had served as executive director of the Carter/Reagan-era commission, got another chance to serve when Clinton appointed his commission. Formed in 1995 and chaired by former Princeton University president Harold Shapiro, Ph.D., NBAC was supposed to first address human subjects protections, genetic information, and gene patenting.
But NBAC abruptly switched gears after the cloning of Dolly the sheep in February 1997, when the president ordered the commission to produce a report on human cloning within 90 days. Acting on NBACs recommendation, Clinton transmitted a proposal to Congress that called for a 5-year moratorium on the use of cloning technology to produce a human being. NBAC based its conclusions largely on considerations of safetythe high likelihood, based on animal experiments, that cloning attempts would produce deformed or otherwise unhealthy people.
Its report left open the question of whether human cloning might be ethically permissible if these technological obstacles were overcome, noting that "concerns relating to the potential psychological harms to children and effects on the moral, religious, and cultural values of society merited further reflection and deliberation." Clintons anti-cloning bill was never enacted, but this year the House passed a new bill that is under deliberation in the Senate.
Annas said NBAC "issued some very interesting reports and has done a pretty good job, but they certainly havent been influential" in the legislative arena. But he added that NBACs most important report was the final one, which is only a few months oldtoo soon to assess its ultimate effect, particularly with the nations attention directed elsewhere since the Sept. 11 terrorist attacks in the United States.
Capron also pointed out that national bioethics commissions can influence policy and practice in a number of ways that do not involve legislative action and often serve as agents of change in concert with other advisory groupssometimes months or years before the final report on an issue is released.
For example, several recommendations contained in NBACs August 2001 report are already being acted on to some extent. NBAC suggested moving federal responsibility for human subject protection out of the Department of Health and Human Services and into an independent body. That step has not been taken, but by the time the final report came out, the departmentacknowledging the problem of a research agency serving as a check on researchershad already shifted this function out of the National Institutes of Health and into a new Office for Human Research Protections at the departmental level. Another suggestion from that report, accreditation of institutional review boards, is likewise being implemented by a coalition of organizations including the Association of American Medical Colleges.
The White House has said nothing further about the new council since Bushs August speech, in which he announced that research on embryonic stem cell lines could receive federal funding only if the cell line was created before that date. Bush said the council will address issues related to embryonic research, assisted reproduction, genetic screening, gene therapy, euthanasia, psychoactive drugs, and brain implants. But chairman-designate Kass, who advised the president on the stem cell issue, said potential topics would not be limited to that list and that "the mandate for this council will be at least as broad as those of previous ones." He declined to discuss his goals for the council in greater detail but added that nominations for 15 to 18 council members "are being gathered from a variety of places, and the final decision will be made in the White House."
A founding member of the Hastings Center, the bioethics think tank in Hastings-on-Hudson, N.Y., Kass is highly respected among bioethics experts as a man of deep and wide-ranging intellect. He teaches the classics at the University of Chicago, where he is the Addie Clark Harding Professor in the Committee on Social Thought and the College.
Proponents of assisted reproduction and other medical means to human "enhancement" will find Kass deeply skepticaleven contemptuousof these technologies. He ominously invokes Aldous Huxleys Brave New World in this contexta reference echoed in Bushs speechand in the May 21 New Republic, he warned that "in leading laboratories, academic and industrial, new creators are . . . quietly honing their skills while on the street their evangelists are zealously prophesying a post-human future."
NBAC member R. Alta Charo, J.D., professor of law and medical ethics at the University of Wisconsin at Madison, said Kass writings suggest he is "unhappy with the enhanced degrees of personal freedom that things like the feminist movement and the reconfiguration of human families have brought to us."
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"A purely emotional or instinctive response to a technology is not a sufficient analysis of the technologys benefits and risks," said Charo. "Our instincts are often shaped by stereotypes and prejudices that need to be carefully deconstructed rather than simply surrendered to in setting public policy."
More immediately relevant for his leadership of the bioethics council is Kass apparent negative view of embryonic stem cell research. His May 2001 New Republic article suggests that he believes embryonic stem cells will prove unnecessary because stem cells from adult body tissues will be an adequate replacementa position many scientists believe is overoptimistic or at least premature.
Although Kass has not avowed opposition to embryonic stem cell research, "he would just be a lot more skeptical about the great benefits to humanity than some others," Annas said, "almost more of a realist." The research community, he added "is going to have to prove to [Kass] that they have something worth doing."
Despite Kass skepticism in print, Capron believes that the new council will aim to "convey the range of opinions as clearly and well as they can be stated for each position ... and push each of them as far as they can go. This would be in contrast to the past commissions, which have generally aimed for and achieved consensus."
Annas added that "the nice thing about Kass is that hes willing to think about [questions like], What does it mean to be human? What is a good life?those kind of classic philosophical questions."
"I dont agree with all his conclusions, but I absolutely respect the depth of his thought," he added. "And at the national level, we should have a group taking on the big issues; otherwise you spend your time putting out fires."
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