American Journal of Law & Medicine

Regulating transfer and use of fetal tissue in transplantation procedures: the ethical dimensions.

I. INTRODUCTION

For twenty years scientists have worked to find an effective treatment to ease the quivering, the stiffness, and the difficulty in controlling bodily movements which are the primary symptoms of Parkinson's disease.(1) The disease can be treated with L-dopa, a drug that mimics the dopamine that coordinates neural transmission in the human brain, which Parkinson's sufferers have ceased to produce in sufficient quantities. The L-dopa, however, produces damaging side-effects and sometimes proves ineffectual.(2) Researchers discovered in animal experiments that the effects of a laboratory-developed disease simulating Parkinson's disease could be mitigated using fetal brain tissue transplants, which produced the natural dopamine the animals' cells failed to produce adequately.(3)

These experiments were replicated with human subjects, and fetal tissue transplants have shown great potential as a treatment for Parkinson's disease.(4) Fetal tissue is ideal for transplantation because it is in a stage of primitive development in which it adjusts easily to a new environment.5 The tissue can replace the normal functions of the cells where it is transplanted and can regenerate itself in ways that adult tissue cannot.6 Furthermore, fetal tissue has not yet formed the propensity to destroy foreign tissue in its environment or to identify itself as foreign tissue in an environment, which makes it unlikely that the tissue will be rejected by its host's antibodies.(7)

Using this principle of the adaptable and regenerative nature of fetal tissue, researchers continued experimental fetal tissue transplantation in animal subjects and found fetal tissue potentially useful in treating Alzheimer's disease,(8) Huntington's chorea,(9) spinal cord injuries,(10) diabetes mellitus,(11) leukemia,(12) Down's syndrome,(13) Tay-Sachs disease,(14) hemophilia,(15) epilepsy,(16) cancer,(17) and perhaps even brain damage caused by an accident or a stroke.(18) Consequently, the demand for fetal tissue in research has increased, but researchers are not always able to fill their need for fetal tissue. The primary constraint on further use of human fetal tissue in research is the controversy surrounding abortion.

This Article explores the political, social, and ethical implications of fetal tissue transplantation. Part II considers the political battle over fetal tissue transplantation research. Part III reviews the current regulations governing fetal tissue transplantation. Part IV addresses common fears about fetal tissue transplantation. Part V discusses the fetus as a symbol of human life. Finally, Part VI concludes that current regulations sufficiently protect fetal tissue transplantation procedures from social and ethical hazards, and that research should be allowed to continue.

II. THE POLITICAL BATTLE OVER FETAL TISSUE RESEARCH AND TRANSPLANTATION

A. THE REAGAN ADMINISTRATION

In October 1987, the Director of the National Institutes of Health (NIH), James B. Wyngaarden, voluntarily sought a second opinion from Robert Windom, the Assistant Secretary of Health and Human Services (HHS) under President Reagan, on fetal and fetal tissue research guidelines.(19) Rather than issuing a second opinion, Windom responded to Wyngaarden's request by placing a moratorium on federally funded fetal tissue research. Windom asked that NIH form a committee to determine the appropriateness of federal funding for fetal tissue research and to develop guidelines for such research if the committee should recommend that it continue.(20) NIH assembled the Human Fetal Tissue Transplantation Research (HFTTR) Panel, composed of medical researchers, lawyers, physicians, politicians, clergy, and ethicists (anti-abortion crusaders among them) to meet during the fall of 1988.(21) The panel voted 19 to 2 to continue funding the research and recommended safeguards to protect the integrity of the process.(22) The HFTTR panel did not discuss the federally funded fetal tissue research ban further at that time because George Bush had recently been elected President and was attending to transitional matters.

B. THE BUSH ADMINISTRATION

In November 1989, the Assistant Secretary of HHS adopted the HFTTR panel's minority position, which stated that women having difficulty deciding whether to abort their fetuses may be swayed by the benefit abortion could provide to a transplant recipient or to science. The Assistant Secretary, therefore, did not lift the ban.(23)

In May 1992, the Bush administration suggested that a fetal tissue bank be established. The bank would collect tissue from ectopic pregnancy abortions and miscarriages.(24) The Bush administration convinced the NIH to manipulate its statistics to show that the number of fetuses obtained from ectopic pregnancies and miscarriages in the United States totalled approximately 2,000 per year.(25) This number implied that a sufficient supply of fetal tissue existed without accessing the controversial fetal tissue supplied by elective abortion.(26) In July 1992, an anonymous spokesperson from the NIH admitted that these figures were ridiculously inflated and that the NIH had computed them based on significant rounding-up and on outrageous assumptions about the conditions under which miscarriages and ectopic pregnancies take place.(27) For example, researchers often cannot collect fetal tissue from a miscarriage because miscarriages do not normally take place in a hospital or clinic. In addition, embryos and fetuses that are spontaneously aborted and ectopic embryos are often genetically abnormal or have viral infections, making the tissue unusable.(28) According to the anonymous NIH spokesperson, a more accurate, but still generous, estimate of the number of fetuses potentially obtainable from ectopic pregnancies and miscarriages is approximately twenty-four fetuses per year in the United States.(29)

The Bush administration proposed the fetal tissue bank in an attempt to appear sympathetic to the needs of medical science while maintaining its close bond with anti-abortion forces. The number of spontaneously aborted or ectopic fetuses available, however, is irrelevant because this defective tissue is not suitable for, and never should be used for, transplantation due to the risk of harm to the tissue recipient.(30) Although defective tissue may be useful in some research, fetal tissue from elective abortions is still a necessary source of tissue for transplantation purposes. The proposed fetal tissue bank, therefore, would not end the controversy.

In June 1992, President Bush vetoed H.R. 2507, the NIH Reauthorization Bill, which proposed programs for a variety of health research projects, including fetal tissue transplantation research.(31) Bush's primary reason for vetoing the bill was that he wanted to "prevent taxpayer funds from being used for research that many Americans find morally repugnant ... and because of its [fetal tissue research using electively aborted fetuses] potential for promoting and legitimating abortion."(32)

The House vote was 271-156, less than the two-thirds majority necessary to override Bush's veto.(33) Undoubtedly some Republicans were concerned about Bush's chances for re-election in 1992,(34) and perhaps others were lulled by the promise of a fetal tissue bank and the misleading NIH report.(35)

In October 1992, the United Parkinson Foundation, the Parkinson's Disease Foundation, and the Juvenile Diabetes Foundation International, joined by the Association of American Medical Colleges and the Association of American Universities, filed suit against Louis W. Sullivan, then Secretary of HHS.(36) The plaintiffs alleged that although the Hyde Amendment, which prevents federal funding for abortions, was found constitutional,(37) it did not apply to research and transplantation of fetal tissue. They argued that such research and transplantation should continue to receive federal funding.(38) Moreover, the plaintiffs alleged that the fetal tissue ban was beyond HHS's authority and, as such, not legally binding.(39)

C. THE CLINTON ADMINISTRATION

When Arkansas Governor Bill Clinton won the presidency in November 1992, NIH officials began drafting executive orders, anticipating that Clinton would move quickly to facilitate fetal tissue transplantation research and would lift the federal funding ban as soon as possible.(40) A member of the Clinton campaign's national health advisory council remarked that Bush's treatment of the fetal tissue debate was governed by his "`pact with the religious right[,]' and that Clinton would `depoliticize' the biomedical process."(41) On January 22, 1993, just two days after his inauguration, President Clinton directed the new Secretary of HHS, Donna Shalala, to lift the ban on federal funding for human fetal tissue transplantation research. In doing so, Clinton said he intended to "free science and medicine from the grasp of politics, and give all Americans access to the very latest and best medical treatments."(42)

III. CURRENT REGULATIONS GOVERNING FETAL TISSUE TRANSPLANTATION

Before exploring the concerns raised by anti-abortion forces, it is useful to survey the regulations that govern fetal tissue transplantation to determine what additional safeguards might be necessary to protect respect for human life. Fetal tissue transplantation need not implicate any form of research on live fetuses, before or after viability, and this Article only addresses the use of material from fetal cadavers. …

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