Abstract
Sometime in the next two years, clinical trials with human gene therapy will begin.1 The trials will be aimed at two rare, very serious single-gene defects. One is Lesch-Nyhan syndrome, a serious and nontreatable disesase characterized by mental retardation, cerebral palsy, self-mutilation, and an accumulation of uric acid in the body. The other is adenosine deaminase deficiency, a disease of the immune system that leads to early death. Like most single-gene defects, they cause their ill effects because the gene essential to turning on the production of a crucial enzyme is missing.
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References
Schmeck, H., Treatment of genetic defects is nearing, New York Times (Apr. 10, 1984), 17; Grobstein, C, Gene therapy: Proceed with caution, The Hastings Center Report (Apr. 1984), 13.
Schmeck, n. 1, supra.
Kolata, G., Gene therapy method shows promise, Science 223:1376–9 (1984).
Schmeck, n. 1, supra.
An account of the Cline affair is presented in the Gore Hearings, pp. 442–460. See n. 9, infra.
Schmeck, n. 1, supra ,reported that the IRB at the University of California at San Diego has approved a trial in carefully selected patients. The Recombinant DNA Advisory Committee of NIH has not yet approved the research but has announced plans to begin reviewing gene therapy on humans. Chronicle of Higher Education (January 4, 1984) 17.
McKusick, V., Diseases of the Genome, JAMA 252:1041 (1984); Bishop, J., Scientists are focusing on genes predisposing people to illnesses, Wall Street Journal (Sept. 12, 1984), 1.
Of course, prevention by means other than gene therapy could occur (E.G., exercise or diet) once the predisposing gene is identified.
Gene Splicing (1983).
Human Genetic Engineering, Hearings before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, U.S. House of Representative, Nov. 16, 17, 18, 1982 (hereinafter, Gore hearings).
Harsanyi, I., Gore hearings, 231–2.
Friedmann, T., Gore hearings, 275–7.
From Chance to Purpose: An Appraisal of External Human Fertilization, (1981), 116.
Despite the Ethical Advisory Board’s recommended guidelines for research with embryos, 44 Fed. Reg. 35033 (June 18, 1979), several witnesses at the Gore hearings on human embryo transfer in August 1984 continued to list experimentation as a major unsolved issue.
The idea of extracting and reinjecting fetal bone marrow is not very different from many other fetal interventions that now occur.
Robertson, J., The right to procreate and in utero fetal therapy, /. of Legal Medicine 3:333–62 (1982). But see contra., Annas and Elias, “Fetal Surgery” chapter, this volume.
Ethical Advisory Board, 44 Fed. Reg. 35033 (June 18, 1979); Report of the Committee of Inquiry into Human Fertilization and Embryology (“Warnock Committee”) (July 1984); Waller Committee Report.
Id.
If the damage of Lesch-Nyhan disease occurs during pregnancy, it would be a candidate for gene therapy on the embryo.
Bayles, MReproductive Ethics ,Prentice Hall, NJ (1984).
Gene therapy, Nature 298:416 (1982).
The importance of viewing gene therapy at any level as one component of a large system of identification and treatment is also discussed by Dr. Harsanyi, n. 10, supra.
Several technical problems now make it impossible to screen the embryo, but these undoubtedly will be removed in the future. Until embryo screening is perfected, a heterozygous couple reproducing by means of IVF could insert the missing gene in all fertilized eggs, as a way of being sure that a defective one is not implanted. Alexander Capron, Remarks at Genetics and Law Conference, April 4, 1984. Although this option may prove risky to the unaffected embryos, it may be that the extra gene will not harm them. The absence of harm would first have to be established by animal studies before it would be ethical to try it on humans.
This is true even if chorion villi sampling allows prenatal diagnosis of the fetus to occur at 8 weeks, rather than at the 15–18 weeks now required for amniocentesis.
Remarks of John Fletcher and Richard McCormack concerning the effect of the emergence of fetal therapy on our perception of the status of the fetus and our obligations to it are applicable here as well.
One may take this position either because he or she believes that the embryo is a moral entity in its own right or because he or she finds its potential to become a person deserving of respect. For a fuller exposition of these points, see Robertson, J., Procreative Liberty and Embryo Transfer (unpublished paper, available from the author).
We can imagine a scenario where four eggs are removed and fertilized. Three are implanted and one is frozen. The three do not implant, and the frozen one, on inspection, is found to have a single-gene defect that could be corrected before transfer to a uterus.
The position asserted here is that true wrongful life claims are in principle plausible but, in actuality, arise in very small percentage of handicapped births. Although there is much room for debate, as the Baby Doe controversy indicates, about whether a given handicap amounts to wrongful life, the courts have almost uniformly rejected wrongful life claims asserted on behalf of unavoidably handicapped children. The recent acceptance of limited wrongful-life claims by the California, Washington, and New Jersey Supreme Courts is only apparent. The claim has been recognized in those cases to ensure that the tortfeasor will bear the full medical and educational costs of the handicapped child. They firmly reject the claim of the child to damages for pain and suffering, which should be awarded if they adopt the position that the child has been wronged by being brought into existence.
These witnesses included Dr. Leroy Walters, pp. 388–9, and Dr. Bernard Davis, pp. 507–9.
Gore hearings, 389.
Id. at 539.
Dr. Leroy Walters, Director of the Kennedy Institute of Bioethics, made this point at the Gore hearings, 388–389.
See n. 19, supra.
See the analysis of this issue in Robertson, J., Procreative Liberty and Embryo Transfer ,n. 25, supra.
Because the technology must be very advanced for this issue even to arise, the person claiming the right would probably be able to replace the gene herself or himself. Should not she or he, rather than her or his parents, have the duty of doing so, if it is so important to her or him?
Abramowitz, S., A stalemate on test-tube baby research, The Hastings Center Report 14:5 (1984). See also Maker v. Roe ,432 U.S. 464 (1977); McCrae v. Harris ,448 U.S. (1980).
The right to a healthy genome could be satisfied by somatic therapy, but in many cases, the therapy will affect the germ line. There is also the question of one’s duties to a future generation.
This paragraph recapitulates the argument made at greater length in Robertson, J., Procreative liberty and the control of conception, pregnancy and childbirth, Va. L. Rev. 69:45 (1983).
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© 1985 John A. Robertson
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Robertson, J.A. (1985). Genetic Alteration of Embryos. In: Milunsky, A., Annas, G.J. (eds) Genetics and the Law III. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-4952-5_11
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