Fetal Tissue Transplantation: Ethical issues

FETAL TISSUE TRANSPLANTATION: PART II. ETHICAL ISSUES by Keith A. Crutcher, Ph.D.

In the first installment in this series, we examined some of the scientific and clinical issues relating to the use of fetal tissue transplantation. In this essay we will look at many of the ethical issues surrounding this topic. One might hope that the scientific or medical establishment would be at the forefront of hosting open discussion but, with few exceptions, the opposite has been the case. In this article we will examine the ethical issues that arise when establishing a policy of using aborted fetal tissue for research or therapy.

Protecting the patient: are transplants effective? One of the first ethical dilemmas surrounding the use of any new procedure to treat any diseases arises from consideration of the effectiveness of the treatment. If there is no compelling evidence that the procedure will work, how can one justify the use of such procedures on patients? As outlined in the last issue of the SFL newsletter, there is little evidence that such transplants will work or, if they do, that they will provide a better treatment than current therapies do. Nevertheless, a number of centers are carrying out these costly surgical procedures. An additional problem of establishing new clinical procedures is that it is difficult to obtain informed consent in such cases. Usually the patient is desperate for any measures that might be effective. When it comes to neurological diseases there is the additional limitation that many of these patients suffer from cognitive impairments that limit their ability to understand either the treatment procedure or the risks involved. The protection of patients is not an ethical issue limited to fetal tissue transplantation. Unlike the situation for approval of new drugs, there is no federal oversight for the implementation of new surgical procedures. As long as a physician is willing to perform the operation, the patient agrees and the procedure is approved by the local institutional review board (IRB), an experimental procedure can be undertaken. The ultimate success or failure of the procedure is determined by the medical community (or the willingness of insurance companies to reimburse the costs). This partly explains why some medical procedures are retained even when there is little evidence of therapeutic potential (frontal lobotomy is an example from an earlier time). The importance of this consideration for evaluating fetal tissue transplantation is that such operations will no doubt continue to be carried out even if there is only weak evidence for effectiveness. In other words, the fact that a procedure is in use cannot be taken as evidence that it is effective or that it has potential effectiveness. The only means of establishing whether a new procedure is effective is to undertake double-blind randomized clinical trials.

Protection of the fetus: Can abortion be separated from the use of fetal tissue? There are unique issues surrounding the use of aborted fetal tissue. First of all, for those who consider elective abortion immoral, the dependence of a medical procedure on an immoral act effectively undermines its ethical justification (3). The rationale that those who will benefit from the abortion play no role in the act of abortion is suspect. A similar defense was used by scientists and physicians in Nazi Germany who argued that the decision to kill was not theirs; they were simply taking advantage of the availability of unique material (2). Some of the medical experiments were undertaken with the rationale that the information would benefit others, e.g., the hypothermia experiments that were conducted to help downed airmen survive in cold waters. Similar arguments are made today by proponents of fetal tissue research who claim that it would be immoral not to use the tissue because it would otherwise be discarded (14). Furthermore, the theoretical separation between the practice of abortion and the use of aborted tissue is simply that, theoretical. There must be close cooperation between the providers and the users of the tissue. In order to be useful for transplantation, for example, the tissue must remain sterile(5). Such precautions are not taken for routine abortions. The possibility that the abortion procedure itself may be altered in other ways is not simply speculative since one study already involved the acquisition of fetal brain tissue prior to completing the abortion (15). In fact, the most compelling evidence supporting the lack of separation between abortion and subsequent acquisition of fetal tissue is that the abortionists are often listed as co-authors on the papers describing the results of fetal tissue research (10,15, 18). This is direct academic compensation for services provided and demonstrates that any barrier between the two is purely hypothetical. It also seems extremely unlikely that the separation between the practice of abortion and the use of the resulting tissue will be maintained by the public. The perceived societal benefits of abortion will likely have an impact on society's attitudes towards abortion an on an individual's decision to abort. (This is the basis of the current administrative ban on federal funding of fetal tissue transplantation.) Certainly, those who have ambivalent feelings about the morality of abortion may take some solace in the notion that individuals could benefit from the availability of the tissue. Whether individual women would consider such benefits in their decision to abort is currently a matter of speculation. However, explicit recognition of the dependence of fetal tissue research on society's continued acceptance of abortion is evident in the sponsorship of a symposium on "The politics of abortion: the impact on scientific research" by NARAL, an organization that has argued that abortion and the use of fetal tissue are separate issues. The possibility that fetal tissue research would have an impact on a woman's decision to abort was considered by the 1988 NIH panel convened to assess the status of fetal tissue research. Many members of the panel felt it was demeaning to women to think that the use of aborted tissue would have some bearing on their decision to abort. However, there have been women who have stated their willingness to abort for the purpose of providing tissue and Dr. Healy, the recently-appointed director of the NIH who also served on the NIH panel, recently stated her dismay at learning that some women hold such views. The only poll that has addressed this issue directly demonstrated that 9% of the women who responded (31 out of 280 women interviewed) would be willing to "get pregnant and abort the fetus" to obtain tissue for treatment of their mother or father (17). On the other hand, the dismay expressed by Dr. Healy, and the proposed guidelines that were adopted by the NIH panel and incorporated in House Bill 2507 that prevent a woman from aborting for the purpose of donating tissue, are difficult to understand if a woman has a right to abortion based on her freedom of choice. Proponents of fetal tissue usage have not usually addressed the question of why the government should be allowed to intervene in a woman's decision to abort when the tissue will be used for medical purposes. It is not obvious why a woman should not be allowed to conceive and abort if her motivation is based on the humanitarian desire to provide tissue for medical benefit but she should be allowed to abort for reasons such as sex selection. In fact, rules that prevent a woman from donating tissue to a relative, such as those proposed by the NIH panel and adopted by the recently-passed House Bill, are unlikely to be upheld in the face of existing legislation permitting abortion as well as the standard practice of permitting donors to specify recipients in virtually every other area of organ and tissue donation. Furthermore, there are significant questions remaining as to whether a woman should be denied potential benefits accruing from the abortion. If a patient is to receive medical treatment as a result of fetal tissue obtained from a woman who decided to have an abortion for some other reason, does this imply that the woman should be denied compensation? Certainly the medical team who performs the transplantation and, theoretically, the recipient of the tissue will benefit financially and medically, respectively, from the aborted tissue. Why shouldn't the woman who donates the fetal tissue also benefit? Much of the precedence for these considerations stems from cases such as that of John Moore whose cells were used to generate income for the scientists who used his spleen cells for research, and eventual profit, without his consent (13). Although the California Supreme Court overturned the lower court's ruling that Moore had a property interest in the tissue, there is likely to be continued debate on whether individuals retain property rights over "bodily products". Criteria for determining death Two principal issues stem from consideration of the established practice of organ and tissue donation as practiced in other areas, i.e., criteria for determining death of the donor and obtaining appropriate consent. Regarding the criteria for defining fetal death in order to obtain "cadaveric" tissue, there are inconsistent guidelines currently in use. Most commonly the cessation of circulation is considered to be sufficient for obtaining fetal tissue (1, 11). Establishing fetal death is necessary because the tissue to be transplanted must be kept alive in order for it to be useful. Somewhat surprisingly, Rep. Waxman (D-Calif.), who sponsored the House bill to overturn the federal ban on fetal tissue transplantation, continues to refer to "dead tissue" in spite of learning that the tissue is of no value for transplantation if it is dead (8). The criteria used for determining death in mature organ and tissue donors has come to rely heavily on the concept of brain death. This is partly due to the fact that the neurological capacities of the individual are commonly accepted as vital to "personhood". It is also the case, however, that mature brain tissue does not show the same capacity for growth and repair that the fetal brain does. In other words, there is no medical motivation for altering the criteria for brain death. However, reliance on "brain death" criteria for obtaining tissue from a fetus would interfere with the acquisition of living brain tissue for transplantation. The use of "cessation of circulation" to define death is convenient for transplantation purposes because the fetal brain is much more resistant to anoxia and ischemia than is the mature brain. This is born out by studies such as the one carried out by Adam et al. in which aborted fetuses (12-21 weeks of gestation) were used for studies of fetal brain metabolism (1,16). Even though "studies were initiated after the fetal heart beat had ceased", brain metabolism was maintained for an hour and a half by perfusion of the decapitated head. In a more recent study, brain tissue was obtained from fetuses aborted via prostaglandin infusion. The fetuses were said to be "dead on expulsion" yet neural tissue was viable even when harvested several hours after expulsion of the fetus (7). The extent to which the "dead" fetus retains pain sensibility is unknown but it is interesting that some proponents of fetal tissue usage have suggested that anesthetics might be needed to circumvent the possibility of fetal pain and suffering (12).

Informed consent of the donor The guidelines currently in use for regulating organ and tissue donations from competent and incompetent individuals are usually based on the Uniform Anatomical Gift Act. The acquisition of tissue or organs from individuals incapable of providing consent depends on obtaining "next-of-kin" consent, the presumption being that the closest living relative is best able to represent the interests of the donor. In the case of fetal tissue donation, the relevant next-of-kin is usually the mother and current practice requires consent of the mother before using aborted fetal tissue for research or therapy. However, it is difficult to understand how the mother who consents to the death of her offspring can be assumed to represent the interests of the fetal donor (6). The mother may have incentives to donate the tissue to alleviate ambivalent feelings about consenting to the abortion but it is difficult to see how she represents the interests of the fetus. An alternative proxy might be identified among those relatives who object to the abortion but it would be difficult to establish such an individual's suitability. Some argue that whatever interests the fetus has are abrogated by the decision to abort and that further violation of any interests is not possible. However, even victims of homicide are treated with respect and dignity when it comes to harvesting organs or other disposition of bodily remains. In fact, some states have laws that require respectul treatment of fetal remains in recognition of the humanity of the aborted fetus. A more bizarre justification for tissue removal from aborted fetuses is the assumption that the fetus would donate if it could (presumed consent). This is the basis on which cadaveric corneas are usually acquired in the U.S. and provides the basis of much organ donations in France. Again, it is difficult to follow the logic of presumed consent in the case of the aborted fetus because the assumption would be that if the fetus could give his or her opinion on the abortion question that no consent would be provided for the procedure that leads to the availability of the tissue.

Summary Ethical issues pertaining to the used of aborted fetal tissue include questions of consent, criteria for determining fetal death and the moral relevance of the procedure (abortion) that makes the tissue available. Many of the scientists and physicians using aborted fetal tissue feel that it would be immoral not to take advantage of the available tissue. A similar argument was made by Nazi physicians and scientists (2, 4). One might ask, however, why the contemporary medical establishment does not question why so much fetal tissue is available. This may reflect a more general belief that the scientific and medical communities have limited responsibility for providing socially-responsible leadership. More cynically, one might wonder whether the benefits to be gained by harvesting the victims of socially-sanctioned "termination" of life prevent objective evaluation of the policies in force. In the next installment we will examine some of the political ramifications of these issues.

References 1. Adam, P.A.J., N. RŠihŠ, E.-L. Rahiala and M. KekomŠki, Acta Paediatrica Scand.,64:17-24, 1975. 2. Alexander, L., New England Journal of Medicine, 241: 40, 1949. 3. Bopp, J., Jr. and J.T. Burtchaell, This World, Summer, No. 26, pp. 54-79, 1989. 4. Brennan, W., Medical Holocausts I: Exterminative Medicine in Nazi Germany and Contemporary America, Nordlund Publishing International, Inc., New York, 1980. 5.Brundin, P., Bjorklund, A. and Lindvall, O., Prog. in Brain Res. 82:707-714, 1990. 6.Burtchaell, J.T., IRB: A Review of Human Subjects Research, 10:7-11, 1988. 7.Detta, A. and E. Hitchcock, Brain Res. 520:277-283, 1990. 8. Fetal Tissue Transplantation Research, Proceedings of Hearing before the Subcommittee on Health and Environment, (serial no. 101-135), April 2nd, 1990. 9. Koistinaho, J., K. HatanpŠŠ and A. Hervonen, Experimental Neurology, 107:277-280, 1990. 10.Lindvall, O., S. Rehncrona, P.Brundin, B. Gustavii, B. stedt, H. Widner, T. Lindholm, A. Bjšrklund, K.L. Leenders, J.C. Rothwell, R. Frackowiak, C.D. Marsden, B. Johnels, G. Steg, R. Freedman, B.J. Hoffer, . Seiger, M. Bygdeman, I. Stršmberg and L. Olson, Prog. Brain Res. 82:729-734, 1991. 11. McCullagh, P., The Foetus as Transplant Donor: Scientific, Social and Ethical Perspectives, John Wiley & Sons, Chichester, Australia, 1987. 12. Mahowald, M.B., J. Silver and R.A. Ratcheson, Hastings Center Report, Feb., pp. 9- 15, 1987. 13. Moore v. Regents of the University of California, 202 Cal. App.3d 1230, 249 Cal. Rptr. 494 (1988), reh. granted, 252 Cal. Rptr. 816, 763 P.2d 479 (1988); Moore v. Regents of the University of California, Supreme Court of the State of California, case No. S006987, July 9, 1990. 14. Neural Grafting: Repairing the Brain and Spinal Cord, OTA Report, Superintendent of Documents, Government Printing Office (GPO stock # 052-003-01212-0), 1990. 15. Olson, L., I. Stršmberg, M. Bygdeman, A.-Ch. Granholm, B. Hoffer, R. Freedman and . Seiger, Exp. Brain Res. 67:163-178, 1987. 16. Rini, S., Beyond Abortion: A Chronicle of Fetal Experimentation, Magnificat Press, Avon, N.J.,1988. 17. Sanberg, P.R., Lancet 335:1594, 1990. 18.Widner, H., P. Brundin, S. Rehncrona, B. Gustavii, R. Frackowiak, K.L. Leenders, G. Sawle, J.C. Rothwell, C.D. Marsden, A. Bjorklund and O. Lindvall, Trans. Proc. 23:793- 795, 1991.

Taken from October, 1991, Vol. 1, Issue 2 of _Science for Life_ ------------------------------------------------------------------------------- This resource file is made available by the editors and contributors to _The ProLife News_, which is a a free, twice-monthly email publication. To receive a sample copy or to subscribe, or to receive a list of all of the available Pro Life resource files available in the ProLife News Archives, please send a email message to the editor: . In all cases, except where explicitly stated, one should assume that the copyright to this file is owned by the author and/or sponsoring organization. Copying of this material is free for non-commercial use, provided that the contents (including this notice) remain intact. -------------------------------------------------------------------------------