Deliberations of the Human Fetal Tissue Transplantation Research Panel

James F. Childress

This case study focuses on the deliberations of the Human Fetal Tissue Transplantation Research Panel during the period September-December 1988. It analyzes the major debates that occurred about conflicting principles and values as a majority of the panel reached the conclusion that the use of human fetal tissue in transplantation research, following deliberate abortions, is “acceptable public policy” if certain “guidelines” are in place. The panel's deliberations occurred in an evolving context that comprised medical-scientific, social-political, legal, and cultural factors. To interpret the panel's deliberations and recommendations, it is necessary to discuss aspects of this context and the background to the panel's efforts.

In addition to drawing on the references and other bibliographic materials listed below, the author held telephone conversations in June 1990 with several people who had been involved at the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS) in decision making, question formation, panelist selection, and other activities involved with human fetal tissue trans-

James F. Childress is the Edwin B. Kyle Professor of Religious Studies and Professor of Medical Education at the University of Virginia. He served on the Human Fetal Tissue Transplantation Research Panel.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 215
BIOMEDICAL POLITICS Deliberations of the Human Fetal Tissue Transplantation Research Panel James F. Childress This case study focuses on the deliberations of the Human Fetal Tissue Transplantation Research Panel during the period September-December 1988. It analyzes the major debates that occurred about conflicting principles and values as a majority of the panel reached the conclusion that the use of human fetal tissue in transplantation research, following deliberate abortions, is “acceptable public policy” if certain “guidelines” are in place. The panel's deliberations occurred in an evolving context that comprised medical-scientific, social-political, legal, and cultural factors. To interpret the panel's deliberations and recommendations, it is necessary to discuss aspects of this context and the background to the panel's efforts. In addition to drawing on the references and other bibliographic materials listed below, the author held telephone conversations in June 1990 with several people who had been involved at the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS) in decision making, question formation, panelist selection, and other activities involved with human fetal tissue trans- James F. Childress is the Edwin B. Kyle Professor of Religious Studies and Professor of Medical Education at the University of Virginia. He served on the Human Fetal Tissue Transplantation Research Panel.

OCR for page 215
BIOMEDICAL POLITICS plantation research. The author is most appreciative for helpful comments from the following: Jay Moskovitz, Charles McCarthy, Miriam Davis, Barbara Harrison, Judy Lewis, and LeRoy Walters. Of course, they are not responsible for errors of fact or interpretation in the case study. BACKGROUND AND CONTEXT By the mid-1980s, promising animal research on fetal tissue transplantation that had been under way for some time both in the United States and abroad had led several researchers in other countries to experimentally transplant human fetal tissue, following elective or spontaneous abortions, into human patients with Parkinson's disease. In addition, in the United States, NIH had awarded an extramural grant to Hans Sollinger of the University of Wisconsin to study transplantation of human fetal pancreatic cells into patients with diabetes. In late 1987 NIH received a request from intramural investigators at the National Institute of Neurological and Communicative Disorders and Stroke for permission to undertake research transplanting human fetal neural tissue, following elective abortions, into patients with Parkinson 's disease. Even though he had the legal authority to approve this research—and some members of his staff urged him to do so—James B. Wyngaarden, the director of NIH, sought approval from the Office of the secretary of DHHS to “permit maximum review of this sensitive area of research” (Office of Science Policy and Legislation, 1988). Wyngaarden's memorandum of October 23, 1987, to Robert Windom, then assistant secretary for health, noted that the proposed research had “the potential for publicity and controversy ” and “may be characterized in the press as an indication that the Department is encouraging abortions,” even though the “research will in no way be a factor in a woman's decision to have an abortion and no Federal funds will directly or indirectly support abortion.” The memorandum also stressed NIH's conviction that “on balance the importance of this research outweighs any potential for adverse publicity.” In a March 22, 1988, memorandum to the director of NIH, the assistant secretary for health declared a moratorium on the use of federal funds to support human fetal tissue transplantation research (hereafter, HFTTR) that used tissue from induced abortions until NIH could convene “special outside advisory committees” to hear testimony, deliberate, and offer their recommendations. His memorandum identified 10 questions that such committees should address (see Appendix A), which focused mainly on the connection or linkage between abortion and the use of human fetal tissue in research. The assistant secretary 's staff

OCR for page 215
BIOMEDICAL POLITICS developed the questions on the basis of an analysis of the existing literature and after consultation with three academic bioethicists. Whereas the NIH director's memorandum focused on the public controversy that might result from the federal government's sponsorship of such research, the assistant secretary's staff perceived the problem as largely ethical. There are several relevant features of the context of the deliberations of NIH, DHHS, and the HFTTR panel. First, there had been earlier research that used human fetal tissue, and many of these projects had support from NIH. In fiscal year 1987, NIH awarded 116 grants and contracts (estimated at $11.2 million) for research that involved the use of human fetal tissue (Office of Science Policy and Legislation, 1988). Most of this research, however, had no direct therapeutic intent and did not involve transplantation. One widely reported earlier example of the use of human fetal tissue in research was in the development of the polio vaccine. Some commentators (e.g., Nolan, 1988) distinguish using cadaveric fetal tissue to develop a treatment from using it as a treatment. Second, animal research had shown that transplantation of human fetal neural tissue might provide therapeutic benefits for patients with Parkinson's disease. Fetal tissue has special features that make it potentially useful in this case—for example, it is immunologically more naive than developed tissue, and it grows and differentiates rapidly. Furthermore, fetal tissue is widely available from the 1.5 million abortions performed in the United States each year. Third, the U.S. Supreme Court decision in Roe v. Wade in 1973 overturned restrictive abortion laws but failed to resolve the serious moral and political debate and conflict about abortion in the United States. Opponents of abortion have been quite active since then and have regularly challenged practices, policies, or laws that appear to encourage abortions. Fourth, beyond the legal framework for abortion, the transfer of human cadaveric tissue is governed by the Uniform Anatomical Gift Act (UAGA), which was adopted by all 50 states and the District of Columbia in the late 1960s and early 1970s. In general, the UAGA permits either parent, subject to the known objection of the other, to donate fetal tissue, following spontaneous or deliberate abortions, for research, education, or transplantation. However, some states restrict the use of fetal materials following induced abortions in some research (DHHS/NIH, 1988; see vol. 1, p. 11, and vol. 2, app. F). Federal regulations permit research “involving the dead fetus, macerated fetal material, or cells, tissue, or organs excised from a dead fetus in accordance with any applicable State or local laws regarding such activities” (45 CFR 46.210). Many of the existing federal regulations focus on research involving the living

OCR for page 215
BIOMEDICAL POLITICS fetus rather than on the use of tissue derived from fetal remains. Also of relevance is the National Organ Transplant Act of 1984 with subsequent amendments, which will be discussed later. PROCESS During early summer 1988, NIH appointed the HFTTR panel to meet in the fall to respond to Assistant Secretary Windom's questions and then to submit its finished report to the NIH Director's Advisory Committee, a diverse outside group that advises NIH on policy matters. NIH had reason to expect that a favorable recommendation from the panel and the advisory committee would lead to DHHS authorization to NIH to approve the research. On the recommendation of an internal, informal ad hoc committee, NIH appointed Arlin Adams, a retired federal judge from Philadelphia, to chair the fetal tissue panel; as a Republican opposed to abortion, he was considered an ideal choice. In addition, NIH appointed special panel chairpersons for scientific issues (Kenneth J. Ryan, a physician and scientist) and ethical and legal issues (LeRoy Walters, an ethicist). Members of Congress, members of the executive branch, and organizations with an interest in the research, among others, submitted nominations for the 21-person panel; the various categories of nominations were ethicists, lawyers, biomedical researchers, clinical physicians, public policy experts, and religious leaders. The ad hoc committee (which included the panel's chair and co-chairs and a member of the NIH Director's Advisory Committee) considered the nominations in early July, emphasizing in their selections the qualifications of proposed panelists and the need for more women and minority panel members. There was vigorous outside support for particular nominees, much of which centered on opponents of abortion; three—James Bopp, James Burtchaell, and Daniel Robinson—were selected. In a departure from the nominations model being used, one senator asked to review the proposed list and personally discussed the proposed panelists with NIH officials prior to their invitation to serve. One of the conditions for serving on the panel was that the prospective panelist had to agree to be available for the first meeting, which was already planned for September 16-18, 1988. After the members of the panel were announced, defenders of HFTTR worried about the presence of strong opponents of abortion on the panel; critics of HFTTR, on the other hand, thought they discerned an overall bias among the panel in favor of such research. (For a list of panelists, see Appendix B.) Just prior to the panel's first meeting, the White House leaked a draft executive order that proposed a ban on transplantation research

OCR for page 215
BIOMEDICAL POLITICS using human fetal tissue following elective abortions. Otis Bowen, then secretary of health and human services, responded that he would not impose new curbs on HFTTR until the advisory committees could make their final recommendations or until he received a direct order from the President. Over the next several weeks, 50 members of Congress wrote to the President urging him to promulgate the executive order that would signify his commitment to protecting unborn lives; several hundred physicians and others also wrote, offering their strong support for the proposed order. However, no action was taken. In September 1988, the HFTTR panel convened to hear scientific, legal, and ethical views from more than 50 invited speakers as well as testimony from representatives of public interest groups. All meetings of the panel were opened to the public after an initial announcement of several closed, executive sessions drew a vigorous negative reaction. When it became clear that the three-day meeting would not be sufficient for the panel to complete its deliberations and offer its response, a second meeting was set for October 20-21. In a draft report considered at the second meeting, the panel offered relatively brief responses to the assistant secretary's questions but little justification for them. During the meeting there was discussion about whether such justifications could be developed without a third meeting; the panel decided to submit only what had been developed and accepted by the time of adjournment. But at the end of the second meeting, James Bopp and James Burtchaell brought in a long dissent to the report. Several other panelists were concerned that this long dissent would overwhelm the brief responses in the report, especially considering that the recommendations were left without sufficient justification. A third meeting was scheduled for December 5, with members of the panel preparing and circulating in advance drafts of “considerations ” for each response to the assistant secretary's 10 questions. At that meeting the report was put into final form: it contains the responses and considerations, along with the panel vote, for each question; a brief summary of the current scientific literature relevant to HFTTR; three concurring statements (Judge Arlin Adams; Aron Moscona, joined by two other panelists; and John Robertson, joined in whole or in part by ten other panelists); two dissenting statements (by David Bleich and by James Bopp and James Burtchaell); and a final dissenting letter (Daniel Robinson). Volume 2 of the report contains the written testimony submitted to the panel. After observing the meetings, science writer Jeffrey Fox described the panel's process: “Despite the diversity of views held by members of the ad hoc panel, the group steadfastly tried to follow a consensual approach during its deliberations. Although consensus was difficult to achieve, the panel members consistently tried to accommodate one

OCR for page 215
BIOMEDICAL POLITICS another's respective positions. Thus, in most cases, very disparate philosophical positions were melded into a coherent stance that was deemed acceptable by a substantial majority of the panel. However, neither of these observations should be taken to suggest that the debate within the panel was somehow constrained by the majority viewpoint, as indeed it was not” (Fox, 1988). The panelists spent a great deal of time debating and modifying the wording of particular responses to gain as much consensus as possible. The majority frequently compromised on the exact wording, but the minority often voted against the response that had been carefully worked out through compromise. The panel experienced other constraints, including the pressure to complete a report as quickly as possible and the lack of staff and resources; originally the panel had been expected to offer a report on the basis of one meeting. The tight schedule, the pressure for a prompt report, and the limited resources all contrasted sharply with the arrangements for other bodies dealing with ethical issues in science and health care, such as the National Commission for the Study of Ethical Problems in Biomedical and Behavioral Research, the President's Commission for the Study of Ethical Problems in Medicine, and the Task Force on Organ Transplantation. Another major constraint was the 10 questions raised by the assistant secretary. As noted earlier, these questions focused on issues related to abortion rather than on issues parallel to transplantation of other cadaveric tissue. Thus, it is not surprising that the panel's deliberations concentrated to a great extent on ethical and societal concerns about abortion without directly addressing the morality of abortion. THE MORAL STATUS OF THE FETUS AND THE MORALITY OF ABORTION With this sketch of the background, context, and process of the panel 's deliberations and recommendations, we can now turn to an examination of the major explicit and implicit issues it faced. One of the major issues involved the status of fetal life—for example, whether the fetus should be viewed as tissue, as a potential human life, or as a living human being. Certainly the members of the panel differed greatly in their individual views on this question, which required some of them to oppose the use of fetal tissue following abortions. Others contended that it was possible to separate, morally and practically, abortions and the use of fetal tissue, despite the fact that elective abortions provide the bulk of tissue for HFTTR. Some panel members contended that their acceptance of various guidelines or safeguards to separate abortion decisions from decisions about the use of fetal tissue did not imply that they viewed abortion as immoral. The recommended guidelines were intended to reduce the

OCR for page 215
BIOMEDICAL POLITICS likelihood that the possibility of donation would influence the pregnant woman's decision to abort. Even if abortion were not viewed as immoral, these guidelines could be accepted for various reasons, including (1) the desire to allay the moral controversy in our society about abortion, or (2) the desire to reduce the vulnerability of some pregnant women to exploitation and coercion because of the need for fetal tissue. These reasons are sufficient to justify the guidelines, without the presupposition that abortion is immoral. Thus, while accepting the proposition that “it is of moral relevance that human fetal tissue for research has been obtained from induced abortions,” the majority of the panel nevertheless held that, in view of the significant medical goals of HFTTR and the legality of abortion, “the use of such tissue is acceptable public policy.” In the consideration it noted for this response, the panel observed that “a decisive majority of the panel found that it was acceptable public policy to support transplant research with fetal tissue either because the source of the tissue posed no moral problem or because the immorality of its source could be ethically isolated from the morality of its use in research” (DHHS/NIH, 1988:2). Thus, the panelists who voted for using fetal tissue for research subscribed to one of two views: (1) that abortion is morally acceptable and the use of aborted fetal tissue for HFTTR is morally acceptable; or (2) that abortion is “immoral or undesirable,” although legal, and HFTTR can be morally separated from abortion and can proceed with appropriate safeguards. The majority rejected the position that HFTTR should be prohibited from receiving federal funds because it is, morally speaking, inextricably linked to or would lead to immoral abortions. COMPLICITY, COLLABORATION, AND COOPERATION IN MORAL EVIL During the panel's deliberations, James Burtchaell, a theologian at Notre Dame University, invoked the language of complicity, collaboration, and cooperation in the moral wrongdoing of others to stress what he considered the impossibility of separating, at least in practice, the use of fetal tissue from the (immoral) abortions that produced it (Bopp and Burtchaell, 1988:63-70). Particularly important for Burtchaell was a form of indirect association that implied moral approval. Cooperation that involves casual actions—for example, driving the getaway car after a robbery—must be distinguished from actions that only symbolize, convey, or express approval but do not materially contribute to the actions themselves. Burtchaell invoked various analogies. One involved the banker in a town in Florida who decided to accept deposits from participants in the drug trade on the grounds that this action would

OCR for page 215
BIOMEDICAL POLITICS benefit the community and that the drug trade would continue regardless of what the banker did. Another was of the researcher who visits an abortionist each week to obtain fetal tissue but who each time expresses his disapproval while planning to return the next week. Burtchaell contends that these actions involve complicity in the moral wrongdoing of others, whether drug trafficking or abortion. According to written testimony from the Bishops' Committee for ProLife Activities of the National Conference of Catholic Bishops, “it may not be wrong in principle for someone unconnected with an abortion to make use of a fetal organ from an unborn child who died as the result of an abortion; but it is difficult to see how this practice can be institutionalized [including arrangements to ensure informed consent] without threatening a morally unacceptable collaboration with the abortion industry” (DHHS/NIH, 1988:E42; for a slightly different version, see G1). What may be possible in the abstract, in principle, or in theory is not possible in practice because of the institutionalization of abortion and the way fetal tissue is currently procured. James Bopp and James Burtchaell write in their dissent: “Our argument, then, is that whatever the researcher 's intentions may be, by entering into an institutionalized partnership with the abortion industry as a supplier of preference, he or she becomes complicit, though after the fact, with the abortions that have expropriated the tissue for his or her purposes. It is obvious that if research is sponsored by the National Institutes of Health, the Federal Government also enters into this same complicity” (Bopp and Burtchaell, 1988:70). There are at least two responses to the charge of moral cooperation in the wrongdoing of others. One is to deny that the primary action, in this case, abortion, is morally wrong; another is to deny that the use of aborted fetal tissue implies approval of abortion. The panel did not try to resolve the debate about the morality of abortion, but the majority insisted that it is at least possible to draw a moral line between the use of fetal tissue and the abortions that make the tissue available in such a way as to ensure that unacceptable moral cooperation does not occur (DHHS/NIH, 1988:2). The majority of the panel noted that it is possible to use organs and tissues from homicide and accident victims without implying approval of homicides and accidents and without diminishing efforts to reduce their occurrence (Robertson, 1988:31-32). Even if one were to accept that abortion is immoral, “it does not follow that use of fetal remains makes one morally responsible for or an accomplice in abortions that occur prior to or independent of later uses of fetal remains” (Robertson, 1988:31). In addition, the majority statement underlined the fact that abortions are already being performed with the result that fetal tissue that could benefit others is being discarded rather than used.

OCR for page 215
BIOMEDICAL POLITICS Several members of the panel strongly objected to the analogies to Nazi research on living subjects invoked by James Bopp and James Burtchaell to illustrate moral complicity in the wrongdoing of others (Bopp and Burtchaell, 1988:63-70). Critics contended that there are several morally relevant differences between the use of tissue from dead fetuses following debatably immoral abortions and the clearly immoral actions of Nazi investigators who experimented on living subjects against their will (Robertson, 1988:32-33; Moscona, 1988:27-28). In a concurring statement, a majority of the panelists noted that the complicity claim “is considerably weakened when the act making the benefit possible is legal and its immorality is vigorously debated, as is the case with abortion. Given the range of views on this subject, perceptions of complicity with abortions that will occur regardless of tissue research should not determine public policy on fetal tissue transplants” (Robertson, 1988:33). Panelists also noted that the loose concept of complicity in the moral wrongdoing of others could be turned in other directions, perhaps even against the positions held by those who invoked it in the context of HFTTR. For example, critics of the application of the concept of complicity in HFTTR argued that a failure to provide sex education, contraceptives, and social support for pregnant women could be construed as modes of complicity and cooperation in the actions of abortion. In this instance, the alleged complicity or cooperation is the material contribution of causal factors through omission. Recognizing that some potential participants in research, whether as patients or as professionals, might want to avoid any connection and thus any felt complicity with abortion, the panel recommended that “potential recipients of such tissues, as well as research and health care participants, should be properly informed as to the source of the tissues in question” (DHHS/NIH, 1988:1-2). INCREASE IN THE NUMBER OF ABORTIONS One fundamental question in the fetal tissue controversy is whether its use in transplantation research would result in an increase in the number of abortions and if so, whether it would still be justified. Answers to this question hinge in part on matters that should be resolvable by empirical data—the reasons why women have abortions. The panel's report noted that “the reasons for terminating a pregnancy are complex, varied, and deeply personal” and “regarded it highly unlikely that a woman would be encouraged to make this decision [to abort] because of the knowledge that the fetal remains might be used in research” (DHHS/NIH, 1988:3). In addition, the panel noted the lack of any evidence

OCR for page 215
BIOMEDICAL POLITICS that, over the past 30 years, the possibility of donating fetal tissue for research purposes had resulted in an increase in the number of abortions (DHHS/NIH, 1988:3). Furthermore, according to the panel majority, it is possible to set up guidelines or safeguards to reduce the likelihood of an impact on the incidence of abortion. Defenders of the minority position argue, however, that knowledge of this possibility of benefit from the provision of fetal tissue would make a difference in some, perhaps even many, cases. There are several possible scenarios addressed by the critics and defenders of HFTTR; they are organized below more systematically than in the HFTTR panel's report. General Altruism First, would the possibility of donating fetal tissue to benefit unrelated and unknown patients through transplantation play a role in a woman's decision to abort? Neither the defenders nor the critics of HFTTR can find strong evidence for their claims about the potential impact of this possibility on individual abortion decisions (DHHS/NIH, 1988:3). The debate thus hinges on speculations about women's abortion decisions and on answers to the moral question about which way society should err in such a situation of doubt. Critics charge that HFTTR would reduce some pregnant women's ambivalence about abortion so that the possibility of an altruistic act—what could be called “general altruism”—would probably lead to some abortions that would not otherwise have occurred. Defenders of HFTTR respond that such a claim is speculative: there is only sketchy evidence about women's decision making about abortion and no evidence that the long-time possibility of donating fetal tissue to benefit others through research (although only rarely through transplantation research) has led to any abortions that would not otherwise have occurred (DHHS/NIH, 1988:3). Even if it was known that the possibility of donating fetal tissue provided a “motivation, reason, or incentive for a pregnant woman to have an abortion,” this would not constitute a prohibited “inducement” (under federal law) because it is not a promise of financial reward or personal gain and is not coercive (DHHS/NIH, 1988:4). In such complex personal decisions as abortion, it is difficult to determine the role of various motives, such as general altruism, and particularly whether these motives are necessary or sufficient for an action. In the case of panel members, however—whether their motives were to protect the fetus, to prevent exploitation and coercion of pregnant women, or to allay moral controversy—the majority of them proposed guidelines to reduce the likelihood that HFTTR would lead some women to abort when they would not otherwise have done so. These guidelines

OCR for page 215
BIOMEDICAL POLITICS include efforts to prevent the stimulation or encouragement of general altruistic motives on the part of pregnant women. According to the panel, “the decision and consent to abort must precede discussion of the possible use of the fetal tissue and any request for such consent as might be required for that use,” and “informed consent for an abortion should precede informed consent or even the preliminary information for tissue donation,” except when the pregnant woman requests such information (DHHS/NIH, 1988:3-4). Ideally, the request and the decision to donate should follow the abortion decision itself, but because postmortem tissue deteriorates quickly and cryogenic storage is not possible for many transplants, “the pregnant woman must be consulted before the abortion is actually performed” (DHHS/NIH, 1988:10). In a concurring statement prepared largely by John Robertson and joined, at least in part, by 10 other panel members, a majority of the panelists allow that even an increase in the number of abortions would not be a decisive reason for rejecting federal support of HFTTR: “Yet even if some increase in the number of family planning abortions due to tissue donation occurred, it would not follow that fetal tissue transplants should not be supported. Surely it does not follow that any increase in the number of abortions makes fetal tissue transplants unacceptable” (Robertson, 1988:34). Drawing a distinction between means, ends, and consequences, this argument denies that an increase in the number of elective abortions is a means to the end of HFTTR. Instead, an increase in the number of elective abortions is a possible consequence, a risk, of the use of HFTTR. Risk is a probabilistic notion and includes the probability of a negative outcome. It is thus necessary to judge the likelihood of a negative outcome along with its magnitude. The risk of an increase in fetal deaths is comparable to other losses of life in the pursuit of important societal goals, such as automobile design, highway engineering, and bridge building. According to Robertson's concurring statement, “[t]he risk that some lives will be lost, however, is not sufficient to stop those projects when the number of deaths is not substantial, when the activity serves worthy goals and when reasonable steps to minimize the loss have been taken” (Robertson, 1988:34). Furthermore, a “more stringent policy is not justified for fetal tissue transplants just because the risk is to prenatal life from some increase in the number of legal abortions” (Robertson, 1988:34-35). Noting that the risk of an increase in the number of abortions is speculative at best, the report's concurring statement stresses that similar speculative and tenuous risks that the society might encourage, as well as legitimate deaths resulting from homicide, suicide, and accidents, to gain organs for transplantation are not viewed as a sufficient reason to stop using organs from these sources (Robertson, 1988:35 [fn. 23]). In a

OCR for page 215
BIOMEDICAL POLITICS sMason, J. O. 1990. Should the fetal tissue research ban be lifted? Journal of NIH Research 2 (January-February):17-18. Moscona, A. A. 1988. Concurring statement. Pp. 27-28 in Report of the Human Fetal Tissue Transplantation Research Panel, vol. 1 (December). Bethesda, Md.: Department of Health and Human Services, National Institutes of Health Nolan, K. 1988. Genug ist genug: A fetus is not a kidney. Hastings Center Report 18 (December):13-19. Office of Science Policy and Legislation, Office of the Director, National Institutes of Health. 1988. Fact sheet: NIH fetal tissue research. Bethesda, Md.: Department of Health and Human Services, National Institutes of Health July 22, 1988. Rich, S. 1989. Senate panel recommends Sullivan for HHS. Washington Post, February 24, 1989, A4. Robertson, J. A. 1988. Concurring statement. Pp. 29-43 in Report of the Human Fetal Tissue Transplantation Research Panel, vol. 1 (December). Bethesda, Md.: National Institutes of Health. Robinson, D. N. 1988. Letter to Dr. Jay Moskowitz. P. 73 in Report of the Human Fetal Tissue Transplantation Research Panel, vol. 1 (December). Bethesda, Md.: National Institutes of Health. Smith, D. H. [Poynter Center]. 1988. Using human fetal tissue for transplantation and research selected issues. Appendix F in Report of the Human Fetal Tissue Transplantation Research Panel, vol. 2 (December). Bethesda, Md.: National Institutes of Health. Tolchin, M. 1989. Bush choice backed for health chief after an apology. New York Times, February 24, 1989, A1 and A13. Vawter, D. E. 1990. The use of human fetal tissue: Scientific, ethical, and policy concerns A report of phase 1 of an interdisciplinary research project conducted by the Center for Biomedical Ethics, University of Minnesota, January 1990. Walters, L. 1988. Statement. In Human Fetal Tissue Transplantation Research, Advisory Committee to the Director. Bethesda, Md.: National Institutes of Health, December 14, 1988. ADDITIONAL BIBLIOGRAPHY Burtchaell, J. T. 1988. University policy on experimental use of aborted fetal tissue. IRB: A Review of Human Subjects Research 10 (July-August):7-11. Burtchaell, J. T. 1989. The use of aborted fetal tissue in research: A rebuttal. IRB: A Review of Human Subjects Research 11 (March-April):9-12. Cefalo, R. C., and H. T. Engelhardt, Jr. 1989. The use of fetal and anencephalic tissue for transplantation. Journal of Medicine and Philosophy 14 (February):25-43. Fine, A. 1988. The ethics of fetal tissue transplants. Hastings Center Report 18 (June-July):5-8. Forum: Neural fetal tissue transplantation scientific, legal, and ethical aspects. 1988. Clinical Research 36:187-222.

OCR for page 215
BIOMEDICAL POLITICS Freedman, B. 1988. The ethics of using human fetal tissue. IRB: A Review of Human Subjects Research 10 (November-December):1-4. Hansen, J. T., and J. R. Sladek, Jr. 1989. Fetal research. Science 246 (November 10):775-779. Lafferty, K. J. 1990. Should the fetal tissue research ban be lifted? Journal of NIH Research 2 (January-February):16, 18. Landau, W. M. 1990. Artificial intelligence: The brain transplant cure for Parkinsonism Neurology 40:733-740. Levine, R. J. 1989. An IRB-approved protocol on the use of human fetal tissue. IRB: A Review of Human Subjects Research 11 (March-April):7-12. Mahowald, M. B., J. Silver, and R. A. Ratcheson. 1987. The ethical options in transplanting fetal tissue. Hastings Center Report 17 (February):9-15. McCullagh, P. 1987. The Foetus as Transplant Donor. New York: John Wiley & Sons. Miller, R. B. 1989. On transplanting human fetal tissue: Presumptive duties and the task of casuistry. Journal of Medicine and Philosophy 14:617-640. Robertson, J. 1988. Fetal tissue transplant research is ethical. IRB: A Review of Human Subjects Research 10 (November-December):5-8. Robertson, J. 1988. Rights, symbolism, and public policy in fetal tissue transplants. Hastings Center Report 18 (December):5-12. Sparks, R. C. 1990. Ethical issues of fetal tissue transplantation: Research, procurement, and complicity with abortion. Paper presented at the annual meeting of the Society for Christian Ethics, Arlington, Va., January 20.

OCR for page 215
BIOMEDICAL POLITICS Commentary Patricia A. King Since the early 1970s, complex ethical, social, legal, and scientific controversies generated by scientific and medical advances have been referred increasingly to national commissions, committees, boards, or panels. The case study of the HFTTR panel 1 underscores the need to assess in a systematic way the goals, structure, and processes of such bodies if they are to continue to successfully resolve significant questions posed by the biomedical sciences. This need is particularly acute with respect to the consensus style that has been the hallmark of these groups. Although the efforts of these groups have sometimes been described as “doing ethics,” 2 it would be more accurate to characterize their activities as developing public policies in the tradition of courts, legislatures, and regulatory agencies. These bodies have been so successful that thoughtful observers such as LeRoy Walters, director of bioethics at Georgetown University 's Kennedy Institute of Ethics, have concluded that, although these groups “are not likely to replace the work of legislators, government agencies, and the courts, periodic committee statements and reports may become the preferred mode of public oversight and social control for at least certain areas of biology and medicine.” 3 The perceived success of these bodies can be attributed to many factors. I believe that three considerations deserve special note. Patricia A. King is professor of law at Georgetown University Law Center and was a member of the HFTTR panel.

OCR for page 215
BIOMEDICAL POLITICS First, the issues posed for these policymaking bodies involve complex social dilemmas that appear to require more flexible and more extensive analysis than that permitted by the institutional restraints placed on courts, legislatures, and regulatory agencies. Typically, these issues are highly controverted and often seem incapable of resolution. While creation of these bodies may allow legislatures and agencies to avoid or defer acting on a difficult matter, 4 many issues are amenable to thoughtful resolution by these interdisciplinary groups. For many controversies, extensive, detailed consideration may be necessary before effective guides for action can be established, especially when existing principles and methods of analysis are inadequate to the task. Indeed, fundamental concepts and ways of thinking may first need to be reexamined. Second, despite the seemingly intractable nature of the issues, the members of these bodies in many instances have been able to reach consensus on their advice or recommendations. This ability to bring order out of chaos gives their reports a compelling quality that facilitates their incorporation into relevant areas of law and public policy. Third, these bodies have explicitly and self-consciously incorporated ethical premises into their deliberations. Their membership or staff (or both) often includes ethicists, philosophers, and theologians. These individuals articulate perspectives that are not ordinarily associated with policy development but that are essential to resolution of these complex issues.5 The inclusion of ethical premises makes clear that the issues under scrutiny are not solely medical or technical in nature and require more than technical expertise to resolve. Success in including ethical premises, however, has obscured the fact that a range of perspectives —social, political, and economic, to name a few—is required for full resolution of these issues. Successful inclusion of ethical premises has also tended to foster the illusion that these bodies have achieved consensus at the level of ethical principle or even ethical analysis. In fact, the consensus usually comes at the level of practice and policy. Moreover, it is not clear whether an effort to reach consensus at the level of principle is either possible or desirable. As Alexander Morgan Capron pointed out in connection with the work of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, “[t]he issues presented by modern medicine and research involve too many of the central facets of human existence to be summed up by a few simple principles.” 6 Clearly, however, ethical principles and concepts are incorporated in the work of these groups, both as a part of a detailed analysis of the dilemmas under scrutiny and as a mechanism to facilitate the acceptance of the bodies' conclusions by persons with diverse religious, cultural, and ethical views. Stephen Toulmin summarizes the utility of appeal to principle in this way: “Principles serve less as foundations, adding intellectual strength or force

OCR for page 215
BIOMEDICAL POLITICS to particular moral opinions, than they do as corridors or curtain walls linking the moral perceptions of all reflective human beings, with other, more general positions—theological, philosophical, ideological, or Weltanschaulich.” 7 The HFTTR panel was created and operated in the tradition of these preexisting national bodies with certain critical differences noted in the case study (staffing, timing, etc.). Significantly, the panel reached consensus on its responses to the questions presented to it. Nevertheless, the careful procedural and substantive examination of the HFTTR panel's operation presented in the case study makes clear that the panel's creation and work, as well as the operation of other such national bodies, need thoughtful scholarly analysis before they can become “the preferred mode of public oversight.” At least two questions posed by the panel 's work require critical examination. The first involves the nature and importance of achieving consensus, especially in a context that touches on abortion. Weisbard and Arras put the problem succinctly when they ask: “[W]hat does ‘consensus' or ‘unanimity' signify, when it is achieved on deeply controversial questions in a society as pluralistic as our own?” 8 Unlike courts, legislators, and regulatory agencies, national bodies like the HFTTR panel have no means to enforce their conclusions or recommendations but instead depend on persuasion for impact. The force of their conclusions seems to depend on whether the body was able to reach consensus. Morris Abram, chairman of the President 's Commission, makes this point powerfully, stating that “a commission requires agreement that is as close to unanimity as possible, to have any effect at all. Without such virtual unanimity, the commission members simply voice powerful arguments; with it, the commission can persuade.” 9 As the case study notes, the drive to achieve consensus was central to the HFTTR panel's work, and, indeed, consensus was achieved. Yet I believe that ultimately the product is not particularly persuasive. The fact that the panel's recommendations were not adopted by the Department of Health and Human Services is not the test of their persuasiveness. Rather, a clue lies in the fact that James Childress 's discussion of the panel's deliberations in the case study is more coherent and consistent than that of the panel. I believe the HFTTR panel report lacks persuasive import because it failed to make clear how persons holding radically different views about abortion could nonetheless agree that the use of fetal tissue from induced abortion is “acceptable public policy ” under specified conditions. It was probably necessary to describe the process that resulted in acceptance of this point rather than merely stating it. In part, the HFTTR panel's failure to explain its conclusions adequately can be attributed to some of the events described in the case study, especially to the fact that the majority initially developed responses and not justifications for its conclusions. Yet I believe there is a deeper problem lurking here. Perhaps in the drive to achieve consensus, the panel gave insufficient atten-

OCR for page 215
BIOMEDICAL POLITICS tion to diverse views, to raising new questions, to stimulating debate, and to furthering societal discussion of controversial matters. Perhaps consensus was achieved at the expense of other functions that these national bodies ought to perform.10 I suggest that one such function would be to reexamine traditional societal values in relation to a given modern dilemma to determine their present-day usefulness. A national group should draw on a variety of sources about norms, methodologies, and culturally informed perspectives in these deliberations. In so doing, it could develop new or revised analytical frameworks within which to examine contemporary issues. If the HFTTR panel had been permitted to engage in this type of effort, its conclusions might ultimately have been more persuasive.11 They surely would have been more coherent. In part, the panel's failure to develop new or revised analytical frameworks is related to its mandate. That point brings me to the second issue that needs critical examination, namely, the nature and structure of the mandate and the mandate's impact on the character of group deliberations. Every good lawyer (and teacher) knows the importance of formulating the right questions because in part the form of the question has implications for the nature of the answer. The HFTTR panel's mandate was in the form of 10 questions it had to answer. As discussed in the case study, these questions focused the group's attention on the connection between fetal tissue transplantation research and abortion. Let us consider, for a moment, what product might have resulted if the question had been something like the following: Under what circumstances, if any, should the federal government support human fetal tissue transplantation research? Several possibilities come to mind. First, the HFTTR panel might have articulated new or revised analytical frameworks that would have helped clarify how persons holding different perspectives could reach consensus at the level of policy recommendations. For example, a person who held that the fetus was mere tissue and a person who held that the fetus was a person might be able to agree that the woman should give consent to the tissue donation. The first person might reach this conclusion because the woman was giving consent to use of her bodily tissue. The other might conclude that the next-of-kin should always give consent to the use of tissue from cadavers where wishes were unknown and where the purpose of the consent was not to further the best interests of the fetus. Second, a more neutrally constructed question that resulted in the articulation of a new or revised analytical framework might have helped clarify the relationship between ethical analysis and policy development. It is not sufficient to ask whether a proposed practice is ethical. There is no necessary symmetry between ethics and public policy. As was evident in the HFTTR panel's work, it is possible to contend that abortion is morally wrong without also contending that the law should prohibit abortion or the use of

OCR for page 215
BIOMEDICAL POLITICS fetal tissue from abortion in research. Moreover, it is possible to consider an act morally acceptable without concluding that it ought to be legal. Ultimately, ethical principles and ethical analysis may be too abstract to provide sufficiently specific guidance for conduct. There are many other considerations that must be taken into account, such as efficiency, cultural pluralism, public sensibilities, and uncertainty about risk, before policies can be developed. If the relationship between ethical analysis and public policy formulation had been better understood, reviewers of the report might have appreciated some of the points about cost-benefit analysis that were made in John Robertson's concurring statement. Moreover, if members of the panel had focused their attention on policy judgments as well as ethical analysis, we might have paid closer attention to such factors as the scientific basis for fetal tissue transplantation research. Finally, a new or revised analytical framework might have helped the panel avoid undue reliance on precedents with their accompanying arguments, stereotypes, and biases. I was often frustrated in the course of the HFTTR deliberations by what I perceived to be an antifemale bias, particularly during the discussions about whether fetal tissue transplantation research would encourage abortion and maternal consent. In my view, stereotypes originating in the abortion discussion obscured the need to better understand the implications of the linkage between the pregnant woman and the fetus in contexts that did not involve abortion directly. There are many other issues associated with the efforts of national bodies that need critical attention.12 In view of the untimely demise of the congressionally created Bioethics Board and the Biomedical Ethics Advisory Committee, which the Bioethics Board established, 13 in part over the abortion controversy, undertaking a critical assessment of the structure and processes of these national bodies assumes new urgency. The case study on the deliberations of the HFTTR panel is an important step in this assessment. NOTES 1. I served as a member of the HFTTR panel. My observations are a product of that experience as well as service on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, and the Recombinant DNA Advisory Committee. 2. For an example, see the reference to remarks of Albert R. Jonsen in Alexander Morgan Capron, “Looking Back at the President's Commission,” Hastings Center Report 13, no. 5 (October 1983):8. 3. Suzanne Wymelenberg for the Institute of Medicine, Science and Babies: Private Decisions, Public Dilemmas (Washington, D.C.: National Academy Press, 1990), p. 154.

OCR for page 215
BIOMEDICAL POLITICS 4. Michael S. Yesley, “The Use of an Advisory Commission,” Southern California Law Review 51 (1978):1452. 5. For a discussion of the implications of philosophers' participation in these bodies, see “Symposium on the Role of Philosophers in the Development of Public Policy,” Ethics 97 (July 1987):775-791. 6. Capron, “Looking Back at the President's Commission,” p. 8, note 2. 7. Stephen Toulmin, “The Tyranny of Principles,” Hastings Center Report 11, no. 6 (December 1981):32. 8. Alan J. Weisbard and John D. Arras, “Commissioning Morality: An Introduction to the Symposium, Commissioning Morality: A Critique of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, ” Cardoza Law Review 6 (1984):226. Ronald Bayer makes the further point that often consensus is illusory, being merely the common view of those who share the same ideology. (See Ronald Bayer, “Ethics, Politics, and Access to Health Care: A Critical Analysis of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research,” Cardoza Law Review 6 [1984]:309.) 9. Morris B. Abram and Susan M. Wolf, “Public Involvement in Medical Ethics,” New England Journal of Medicine 310, no. 10 (March 8, 1984):629. Alexander Morgan Capron, executive director of the President's Commission, noted the benefits of consensus but was more cautious, observing that “only time will tell whether consensus was ever bought at too great a cost; my sense is that it was not” (Capron, “Looking Back at the President's Commission,” p. 8, note 2). 10. This point was made by several commentators on the work of the President's Commission. For example, Jay Katz said: “The morality of commission reports, past and future, requires study of the question of whether societal morality is better served by documenting the complexities inherent in any ethical recommendation for the conduct of human affairs than by making light of the complexities through striving for a consensus report” (Jay Katz, “Limping Is No Sin: Reflections on Making Health Care Decisions,” Cardoza Law Review 6 [1984]:247). 11. With respect to the issue of human fetal tissue transplantation research, private groups have attempted to fill this void. The efforts of the Center for Biomedical Ethics at the University of Minnesota are particularly noteworthy. See Dorothy E. Vawter et al., The Use of Human Fetal Tissue: Scientific, Ethical, and Policy Concerns, A Report of Phase I of an Interdisciplinary Research Project conducted by the Center for Biomedical Ethics (Minneapolis: University of Minnesota, 1990). 12. For a list of questions, see Weisbard and Arras, “Commissioning Morality,” p. 226, note 8. 13. The Bioethics Board expired in 1989 (135 Cong. Rec. S15309 [November 9, 1989]). It was charged with examining on a continuing basis “ ethical issues arising from the delivery of health care and biomedical and behavioral research.”

OCR for page 215
BIOMEDICAL POLITICS Commentary Walter Harrelson It is good to have a case study outlining the process by which a group of medical and nonmedical specialists arrived at a set of recommendations to a governmental body concerned with health. The case study by James Childress charts the course traversed by the HFTTR panel in reaching the conclusions and recommendations contained in its report to the U.S. Department of Health and Human Services. The work of this panel shows the value and limitations of using panels of medical and nonmedical experts, working together over time, to frame policy for the nation in instances that involve highly controversial and divisive issues. Both the value and the limitations of such groups are related to their process. Often, the issues can come into clearer focus through such deliberations if panelists are carefully selected and the panel has sufficient time to work together under a leadership that presses for clarity and consensus. Even under optimal circumstances, however, it is difficult to reach a useful consensus about such matters and to agree on language that is publicly comprehensible and aesthetically appealing to general readers. The list of questions presented to the panel by the assistant secretary for health was quite specific, but the questions invited, and may have been intended to produce, debate over a rather wide front. Some of them were general Walter Harrelson is Distinguished Professor of Hebrew Bible, emeritus, at Vanderbilt University and former dean of its Divinity School.

OCR for page 215
BIOMEDICAL POLITICS public policy questions; some were legal and others medical questions. Some in particular required extended deliberations by moral philosophers, ethicists, and theologians. The members of the panel seem to have been well equipped to deal with most, if not all, of these questions. Some panel members focused almost exclusively on the question of how the use of human fetal tissue might encourage abortion or constitute an action that could involve “complicity” in abortion. As a result, most of the panel's time was devoted to this central question. The case study indicates that the Department of Health and Human Services received what it desired: a sophisticated set of responses to questions touching on legal, medical, moral, and general public policy aspects of the use of fetal tissue for transplantation, questions that, because of their link to the politically volatile issue of abortion, were under rigorous discussion within U.S. society. The panel composition may not have been ideal, because the responses of some panelists did not allow the discussion to maintain its focus on the use of fetal tissue obtained through induced abortions. But discussions of issues of this sort frequently take the course that the participants demand. Did, however, Health and Human Services, and the public generally, get what it most needed from the panel's report? I would argue that it did not. What was most needed was not only a cogent, clarifying discussion of the issues by medical and nonmedical experts but also a rhetorically and aesthetically attractive report. When one enters the field of public policy debate on issues that are as strongly controversial as abortion, one must find a language and a set of images that will help a polarized community begin to build elements of consensus. It is important, indeed, that the panel itself was able to arrive at a consensus that included persons with quite different views on abortion. It is equally important that the positions of those panel members who dissented were powerfully and eloquently stated, so that political decisions would not be made without a sharpened awareness of such positions. What was lacking in the case study, and apparently lacking in the report of the panel, was a document of the style that is urgently needed today: an eloquent, appealing, quotable report that can assist the decision maker both in the making and later in the defense of difficult policy decisions. This report was not primarily a scientific or a fact-finding report but one that described the deliberations of specialists from a number of disciplines who sought to clarify and move to a different level a controversy that urgently required both; that is, clarification and restatement in more useful, usable terms. When the experts themselves fail to provide this second articulation of the fruits of their deliberations, they leave the door open for two particularly unhappy outcomes (plus others, no doubt). One of these outcomes is apparent in this case: the administrator decides to do nothing—to leave standing the moratorium on governmental funding of fetal tissue transplan-

OCR for page 215
BIOMEDICAL POLITICS tation research. The other has also appeared, and will appear again and again: administrators and political leaders resort to their own forms of persuasion and demagoguery in dealing with the issue, and the public is neither better informed nor provided with fresh terms and images with which to view and address the issue. In this regard, the panel missed a fine opportunity.