A Look Back At NBAC

Despite the presence of Hurricane Floyd and the resulting absence of more than half of the members, the National Bioethics Advisory Commission (NBAC) convened its 34th meeting Sept. 16-17 in Arlington, Va. The location of the meeting--a modest, drab hotel conference room--belied the serious subject matter of the day: "international bioethics," a preliminary consideration of bioethical regulations for research that runs between borders and cultures. It's the latest of an array of tough topics tackled by the commission. Created four years ago by President Bill Clinton, NBAC--a handpicked team of 18 bioethicists, lawyers, Ph.D.s, and M.D.s--just got its second two-year extension this September. The commission, which has public meetings every month or so, will be dissecting bioethical dilemmas into at least 2001. Commission members faced a daunting task from the very beginning. Their original charge was to come up with potentially policy- and law-inspiring reports on bioethically sensitive issues related to both the rights and the welfare of human research subjects, and the use of genetic information in enterprises such as human gene patenting. (Reports are on the Web at www.bioethics.gov/pubs.html.) The scope of NBAC's focus would later widen considerably to include issues ranging from health care to cloning. "We've had this funny mix of things that are given to us by the president on short notice, things that are part of our initial charge, and things that we develop on our own," explains commissioner Bernard Lo, director of the program in medical ethics at the University of California, San Francisco. One of an estimated 35 like-minded national bioethical regulatory organizations around the world, according to executive director Eric Meslin, NBAC directs its recommendations to the National Science and Technology Council and other governmental entities. A $2.5 million annual budget funds its projects, several of which are usually conducted simultaneously. "I used to say we were laboring in happy and impoverished obscurity--until Dolly came along," notes commissioner Thomas Murray, president of the Hastings Center in Garrison, N.Y., and incoming president of the American Society of Bioethics and Humanities. According to NBAC chairman and Princeton University president Harold Shapiro, the June 1997 "Cloning Human Beings" report may have, in fact, been the commission's hardest assignment, especially given that they had a mere 90 days to complete it. Says Murray: "It was intellectually an enormous challenge, it was a fascinating topic, it was an impossible task, and in effect, it sort of ripped us [commissioners] out of our lives for three months." He adds that being a commissioner, which pays $150 per meeting day, can sometimes be a full-time job by itself. Perhaps as challenging as the cloning report was the recently released "Ethical Issues in Human Stem Cell Research," which endorsed government funding for stem cell research that uses embryonic tissue taken from either elective fetal abortions or unwanted embryos created by in vitro fertilization. Although the deadline pressure wasn't quite on a par with the cloning report (they wrote the stem cell report in about six months), stem cell research is in some sense, says Shapiro, a weightier issue. In preparing the cloning report, the commission had to fight against the strong tide of misleading fictional literature available to the public. For the stem cell report, it was instead res-ponding to an abundance of scientific literature on the potential therapeutic power of stem cells; the more pressing struggle, then, was with the ethical viability of using federal funds to harvest the cells from embryos. "There was no way to escape the moral, legal, and political controversy ... over how we deal with human embryos as a matter of public policy," says Murray. According to Lo, in both cases NBAC was able to get past its limitations and put together relatively timely analyses of novel issues. "The ability to respond to a new ethical challenge posed by unanticipated scientific discoveries ... was an important thing to establish," he says. At the Sept. 16-17 meeting of the National Bioethics Advisory Commission (NBAC), members, expert witnesses, and several M.D. and Ph.D. research consultants discussed a number of issues pertinent to international bioethics. The discussion focused primarily on the bioethical intricacies of carrying out large-scale clinical studies led by Western researchers and Western science but geared toward the populace of a foreign (usually a developing) country--for example, U.S. researchers conducting a study in Malaysia on the possible effects of a vitamin A deficiency. It was the first time the commission looked at the topic in detail. A few of the questions raised by the panel included: Whom should NBAC contact to investigate policies on international studies--schools of public health, nonprofit foundations, others? How important is it to calculate a risk-benefit analysis for the subjects who participate in international studies and the researchers and companies funding the study? Can you justify approving an inferior treatment that costs less--and is therefore much more likely to be administered nationwide in a developing country--in place of a more costly but more effective treatment? How do you meet the higher burden of proof in developing countries? According to expert witness Alfred Sommer, dean of the school of public health at Johns Hopkins University, studies must go beyond simply demonstrating statistically significant effectiveness. Because the public health budgets in poor countries are extremely tight, treatment effectiveness must be nearly guaranteed. Implementing a new public health initiative might mean diverting money from another important public health effort. How should foreign researchers deal with local opposition to their studies? How many clinical trials are enough to convince countries to implement treatment? Some governments won't respect or trust findings based on trials done in other countries. India, for example, isn't likely to accept study results from Bangladesh. What are some immutable bioethical guidelines that Western researchers should follow when conducting studies on a foreign populace? Should the NBAC international bioethics report make an effort to focus on bioethics issues related to people other than the poorest in a country? (The subjects of studies akin to those discussed at the meeting are generally from the lower classes.) How can NBAC get a better sense of the points of view of not only U.S. public health officials and international researchers, but also those of study subjects? A few NBAC commissioners asked for more specific examples from research consultants who presented their case-study-based findings on the interaction between local subjects and physicians, and the foreign researchers they're working with. --Eugene Russo While both the cloning and stem cell reports received considerable media attention, other reports, though perhaps significant, weren't as popular. Regarding the May 1999 report "Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity," commissioner Patricia Backlar suggests that although the report itself received some much-deserved attention, the coverage was too often "deflected to what was extreme." "We try to think through all the things [that matter] to people who are without a voice," comments Backlar, assistant director of the center for ethics in health care at Oregon Health Sciences Uni-versity in Port-land. Lo, Murray, and Shapiro all point to the August 1999 report "Re-search Involving Human Biological Materials: Ethical Issues and Policy Guidance," as the most overlooked report in terms of public interest. "I suspect it's gotten a lot of attention within the community of researchers and research sponsors and hospitals," remarks Murray. Every time someone has a biopsy or has an organ removed, the pathology lab involved usually retains part of the patient's tissue specimen. The estimated 282 million such tissue samples stored in labs throughout the country have tremendous potential as research tools for investigating any number of health conditions. The materials report, which took a whopping two years to complete, addresses the ethics surrounding access to these specimens: Should researchers be allowed to study them--and look for, for example, genetic predispositions to cancer--without getting the consent of the person who donated the specimen? NBAC made 23 recommendations pertaining to appropriate oversight, Institutional Review Board review, and public policy. But they are, of course, only recommendations. NBAC is an advisory, not a lawmaking, body. Murray recounts how, as part of the commissioners' public meetings, they've had tactical conversations in which they decide against recommending a new or revised law despite agreeing that such a change would probably be the best option. Instead, they elect to focus on more doable, "second-best" fixes that wouldn't entail writing a new regulation or passing any new legislation. "We recognize that the more we ask for, even if it's a simpler, more elegant solution, the less likely it is to happen," says Murray. "So it's always a balance--do you want to dream about an ideal world, which we do at times, [or] do you want to try to make an impact immediately, even if it's a little rougher around the edges." NBAC, says Lo, has tried to put out very specific recommendations. "Rather than saying 'more attention needs to be paid to the ethical equation,' [we say] we want NIH to do this, we want editors of medical journals to do that, we want professional scientific organizations to do this." Even so, the impact and influence of NBAC on policy is hard to gauge. "Their best function would be to try to clarify issues, rather than to take a stand," says Daniel Callahan, cofounder of the Hastings Center and its current director of international programs. Callahan suggests that NBAC and like commissions are best suited to explaining complex bioethical issues to the public--something he believes NBAC has done well. However, Callahan does not see why an 18-person advisory panel with no real legislative power should also add yet another "for or against" verdict to volatile bioethics issues. And he contends that the mostly scientist and bioethicist panel does not reflect the diversity of Congress and that its recommendations will not be taken seriously. NBAC's recommendation for a five-year moratorium on cloning, for example, doesn't seem likely to materialize. "It was sort of a shame that they weren't able to reach agreement on the moral issues, and only on the issue of safety," Callahan says, referring to the cloning report. "We really loathe to tell Congress what to do," Lo admits, smiling. "They're sort of their own bosses." Getting through to researchers in the private sector is equally difficult. Although not responsible for monitoring or changing private practices, NBAC does often outline why it believes it's in companies' best interest to consider the commission's recommendations. Doing so was particularly important in the case of the stem cell report. "We tried to say that if you have this two-tiered system where there's a strong oversight of federally funded research, but no oversight of privately funded research, you're not going to have confidence in the whole enterprise, and scientific progress will be impeded," explains Lo. Limitations aside, NBAC is looking ahead to the next two years, already composing its "to do" list. Planned topics include follow-up work on international bioethics, an overall assessment of the system currently in place for protecting human subjects, and possibly a look at issues surrounding access to medical records. Also high on the list is gene patenting. Although part of NBAC's original charge, the subject hasn't yet gotten a close look from the panel. "Many people are quite leery of the concept of patenting a human gene and would be shocked to know that it's already happened," says Murray. "It's the sort of thing [where] NBAC can perform a legitimate public education role--I'd like to see us take that one." Eugene Russo can be contacted at erusso@the-scientist.com. In a subtle but significant departure from a bioethics stem cell report from the American Association for the Advancement of Science (AAAS) and the position of the National Institutes of Health, a September report from the National Bioethics Advisory Commission (NBAC) has deemed it appropriate for the federal government to fund not only the use of embryonic stem cells for research, but their derivation as well. The AAAS and the NIH, whose soon-to-be-released official guidelines on stem cell research will take into account the advice of NBAC, have thus far only supported funding for embryonic stem cell use. According to the AAAS panel, the derivation of human stem cells can, in fact, be done ethically. However, it stated that there's "enough objection to the process of deriving stem cells to consider recommending against its public funding." "We said ethically that doesn't make a whole lot of sense," says NBAC commissioner Bernard Lo, director of the program in medical ethics at the University of California, San Francisco. "You should either fund both or fund neither, and we think it's appropriate to fund both research and derivation." All three bodies have only endorsed funding research involving cells taken from aborted fetuses or from embryos left over from infertility treatments. Embryos created specifically for the purpose of stem cell derivation, or those using various cloning techniques, should not, say the panels, be permissible sources for derivation. The NBAC report, called "Ethical Issues in Human Stem Cell Research," was first requested by President Bill Clinton in November 1998. "There's a range of views on the commission about embryo research," says NBAC member Thomas Murray, president of the Hastings Center in Garrison, N.Y., and incoming president of the American Society for Bioethics and Humanities. "They needed a lot of time and effort to work through the question whether there should be federal funding for the derivation of stem cells." Murray himself actually disagreed with those members who thought it was dishonest to fund use and not derivation. "There are lots of cases where you try to accomplish important and legitimate policy goals and also respect people's feelings and moral sentiments. If by not funding derivation and only funding use we could avoid offending the sensibilities of a lot of Americans, then that would be a reason to take that approach." But in the end, says Murray, the panel's demonstration of scientific and clinical impact was sufficient to allay his and other commissioners' concerns. www.aaas.org/spp/dspp/sfrl/projects/stem NIH Fact Sheet on Stem Cell Research (April 21, 1999) www.nih.gov/news/pr/apr99/od-21.htm Executive Summary of the NBAC report, "Ethical Issues in Human Stem Cell Research," September 1999 www.bioethics.gov/pubs.html Debate on the subject has not subsided since advances in stem cell research spurred a closer look at its bioethical implications a year ago. "The stem cell report ... provided a sort of balanced reflection on all the aspects of the issues," says Kevin Wildes, a Catholic priest and the associate director of the Kennedy Institute of Ethics at Georgetown University. Wildes, who testified before the commission as an expert witness at an NBAC meeting investigating religious aspects of the topic, supports federal funding for both use and derivation. "This kind of research is just going to be too offensive to large numbers of people in this country," counters bioethicist Daniel Callahan, cofounder of the Hastings Center and its current director of international programs. "The scientific community has got an awful lot of self-interest at stake here .... They're a kind of lobbying advocacy group, and it's hardly surprising that they want the research done any more than it's ... surprising that the pharmaceutical industry doesn't want price control." Callahan guesses that although scientists will praise the NBAC report, Congress, especially conservatives, will take it less seriously. --Eugene Russo

A Look Back At NBAC

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