Human fetal gene therapy: Moral and ethical questions

Human Gene Therapy

Volumn 7, Issue 13, 1996, Pages 1605-1614

  Fletcher, John C ^a,d   Richter, Gerd ^b,c  

^a UNIVERSITY OF VIRGINIA   (United States)

^b PHILIPPS UNIVERSITY MARBURG   (Germany)

^c UNIVERSITY OF VIRGINIA   (United States)

^d UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; FETUS; FETUS DISEASE; GENE THERAPY; GENETIC RISK; GERM LINE; HEALTH ECONOMICS; HUMAN; INDUCED ABORTION; MEDICAL ETHICS; MORALITY; PATIENT SELECTION; PRENATAL DIAGNOSIS; RISK; SOCIAL ASPECT;

EID: 0029784268     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/hum.1996.7.13-1605     Document Type: Article

References (82)

1. AD HOC COMMITTEE ON GENETIC COUNSELING. (1975). Genetic counseling. Am. J. Hum. Genet. 27, 240-242.
2. ANDERSON, C. (1994). France to ban embryo research. Science 264, 1655.
3. ANDERSON, W.F., and FLETCHER, J.C. (1980). Gene therapy in human beings: When is it ethical to begin? N. Engl. J. Med. 303, 1293-1297.
4. ANDERSON, W.F., BLAESE, R.M., NIENHUIS, A.W., and O'REILLY, R.J. (1987). Human Gene Therapy Preclinical Data Document. (Human Gene Therapy Subcommittee, Bethesda, MD). April 24.
5. BANKOWSKI, Z., and CAPRON, A.M., eds. (1991). Genetics, Ethics, and Human Values. (CIOMS, Geneva), Proceedings of the XXIVth CIOMS Conference), pp. 1-3.
6. BEECHER, H.K. (1996). Ethics and clinical research. N. Engl. J. Med. 274, 1354-1360.
7. BERG, P. (1983). In Gene Therapy: Fact and Fiction. T. Friedman, ed. (Banbury Public Information Report, Cold Spring Harbor, NY).
8. BLACK, R.B. (1989). A 1 and 6 month follow-up of prenatal diagnosis patients who lost pregnancies. Prenat. Diagn. 9, 795-801.
9. BLAESE, R.M., CULVER, K.W., MILLER, A.D., CARTER, C.S., FLEISHER, T., CLERICI, M., SHEARER, G., CHANG, L., CHIANG, Y., TOLSTOSHEV, P., GREENBLATT, J.J., ROSENBERG, S.A., KLEIN, H., BERGER, M., MULLEN, C.A., RAMSEY, W.J., MUUL, L., MORGAN, R.A., and ANDERSON, W.F. (1995) T lymphocyte-directed gene therapy for ADA-SCID: Initial results after 4 years. Science 270, 475-480.
10. BLUMBERG, B.D., GOLBUS, M.S., and HANSON, K.H. (1975) The psychological sequelae of abortion performed for a genetic indication. Am. J. Obstet. Gynecol. 122, 799-803.
11. BOBROW, M. (1995). Redrafted Chinese law remains eugenic. J. Med. Genet. 32, 409.
12. BORDIGNON, C., NOTARANGELO, L.D., NOBILI, N., FERRARI, G., CASORATI, G., PANINA, P., MAZZOLARI, E., MAGGIONI, D., ROSSI, C., SERVIDA, P., UGAZIO, A.G., and MAVILIO, F. (1995). Gene therapy in peripheral blood lymphocytes and bone marrow for ADA-immunodeficient patients. Science 270, 470-475.
13. COALE, A.J., and BANISTER, R. (1994) Five decades of missing females in China. Demography 31, 459-479.
14. COUTELLE, C., DOUAR, A.M., COLLEGE, W.H., and FROSTER, U. (1995). The challenge of fetal gene therapy. Nature Med. 1, 864-866.
15. COWAN, M.J., and GOLBUS, M. (1994). In utero hematopoietic stem cell transplants for inherited diseases. J. Ped. Hemat./Oncol. 16, 35-42.
16. CROMBLEHOME, T.M., and BIANCHI, D.W. (1994). In utero hematopoietic stem cell transplantation and gene therapy. Sem. Perinat. 18, 376-384.
17. DAVIS, B.D. (1970). Prospects for Genetic Intervention in Man. Science 170, 1279-1283.
18. DO, W., and MOSHER, S. (1994). One Woman's Fight Against China's One-Child Policy. (HarperCollins, New York).
19. DONNAI, P., CHARLES, N., and HARRIS, R. (1981). Attitudes of patients after "genetic" termination of pregnancy. Br. Med. J. 282, 621-625.
20. ELDER, S.H., and LAURENCE, K.M. (1991). The impact of supportive intervention after second trimester termination of pregnancy for fetal abnormality. Prenat. Diagn. 11, 47-52.
21. EVANS, M.I., CHROUSOS, G.P., MANN, D.W., LARSEN, J.W., GREEN, I., McCLUSKY, J., LORIAUX, D.L., FLETCHER, J.C., KOONS, G., OVERPECK, J., and SCHULMAN, J.D. (1985). Pharmacologic suppression of the fetal adrenal gland in utero. J. Am. Med. Assn. 253, 1015-1020.
22. EVANS, M.I., HARRISON, M.R., NICOLAIDES, K.H., et al. (1992). Fetal therapy. In Genetic Disorders and the Fetus. Diagnosis, Prevention, and Treatment. 3rd ed. A. Milunsky, ed. (Johns Hopkins University Press, Baltimore, MD), pp. 771-797.
23. FLAKE, A.W. (1995). Successful treatment of X-linked recessive severe combined immunodeficience (X-SCID) by the in utero transplantation of CD34 enriched paternal bone marrow cells. Blood 86 (Suppl. 1), 125a.
24. FLETCHER, J.C. (1972). The brink: The parent-child bond in the genetic revolution. Theol. Stud. 33, 457-485.
25. FLETCHER, J.C. (1975). Abortion, euthanasia, and the care of defective newborns. N. Engl. J. Med. 292, 75-78.
26. FLETCHER, J.C., and JONSEN, A.R. (1990). Ethical considerations of fetal therapy. In Unborn Patient, 2nd ed. M.R. Harrison, M.S. Golbus, and R.A. Filly, eds. (Grune & Stratton, Orlando, FL), pp. 159-170.
27. FLETCHER, J.C., and ANDERSON, W.F. (1992). Germ-line gene therapy: A new stage of debate. Law Med. Health Care 20, 26-39.
28. FLETCHER, J.C, and MILLER, F.G. (1996). The promise and perils of public bioethics. In The Ethics of Research Involving Human Subjects, H.Y. Vanderpool, ed. (University Publishing Group, Frederick, MD), pp. 155-184.
29. FRIEDMAN, T., and ROBLIN, R. (1972). Gene therapy for human genetic disease? Science 175, 949-955.
30. GAVAGHAN, H. (1994a). Fetal gene therapy under the microscope. Nature 372, 490.
31. GAVAGHAN, H. (1994b). As U.S. bans "embryos for research." Nature 372, 490.
32. GOLBUS, M.S. (1985). Introduction. Sem. Perinat. 9, 51.
33. GOLBUS, M.S., FILLY, R.A., CALLEN, P.W., et al. (1985). Fetal urinary tract obstruction: management and selection for treatment. Sem. Perinat. 9, 91-97.
34. GRIFO, J., TANG, Y.X., ALIKANI, M., et al. (1993). First babies born in the USA after preimplantation genetic diagnosis of sex-linked diseases. Am. J. Hum. Genet. 3 (Suppl. 53), 7.
35. HANDYSIDE, A.H. (1992). "Clinical experience in preimplantation diagnosis." Paper presented at International Symposium on Preimplantation Genetics and Assisted Fertilization, Brussels.
36. HANDYSIDE, A.H., KONTOGIANNI, E.H., HARDY, K., and WINSTON, R.M.L. (1990). Pregnancies from biopsied human preimplantation embryos sexed by specific DNA amplification. Nature 344, 768-770.
37. HANDYSIDE, A.H., LESKO, J.G., TARIN, J.J., et al. (1992). Birth of a normal girl after in vitro fertilization and preimplantation diagnostic testing for cystic fibrosis. N. Engl. J. Med. 327, 905-909.
38. HARRISON, M.R., et al. (1982) Fetal treatment. N. Engl. J. Med. 307, 1651-1652.
39. HARRISON, M.R., LANGER, J.C., ADZICK, N.S., et al. (1990). Correction of congenital diaphragmatic hernia in utero. Initial clinical experience. J. Pediat. Surg. 25, 47-57.
40. HIRSCHHORN, K. (1972). Practical and ethical problems in human genetics. Birth Defects. Original Article Series 8, 17-30.
41. JACOBS, L.R. (1995). Politics of America's supply state. Health Affairs 14, 143-157.
42. JACOBSON, C., and BARTER, R. (1967) Intrauterine diagnosise and management of genetic defects. Am. J. Obstet. Gynecol. 99, 769-772.
43. JENKS, S. (1993). Infants' gene therapy gains easy RAC approval. J. Natl. Cancer Inst. 85, 1108-1109.
44. JONES, O.W., PENN, N.E., SCHUCTER, S., et al. (1984). Parental response to mid-trimester therapeutic abortion following amniocentesis. Prenat. Diagn. 4, 249-253.
45. JUENGST, E.T. (1990). The NIH "Points to Consider" and the limits of human gene therapy. Hum. Gene Ther. 1, 425-433.
46. JUENGST, E.T. (1995). Prevention and the goals of genetic medicine. Hum. Gene Ther. 6, 595-605.
47. KAISER, J. (1995). Congress bans embryo study funds. Science 271, 585.
48. KARPATKIN, R.H., and SHEARER, G.E., (1995). A short-term consumer agenda for health care reform. Am. J. Publ. Health 85, 1352-1355.
49. KOLDER, V.E., GALLAGHER, J., and PARSONS, M.T. (1987). Court-ordered obstetrical interventions. N. Engl. J. Med. 316, 1192-1196.
50. LAPPE, M. (1991). Ethical issues in manipulating the human germ line. J. Med. Phil. 16, 621-641.
51. LEDLEY, F.D. (1993). Prenatal application of somatic gene therapy. Obstetr. Gynecol. Clin. North Am. 20, 611-620.
52. LEJEUNE, J. (1970). On the nature of man. Am. J. Hum. Genet. 22, 121.
53. LESCHOT, N.J., and VERJAAL, M. (1982). Therapeutic abortion on genetic indications. A detailed follow-up study of 20 patients. In On Prenatal Diagnosis. M. Verjaal and J.H. Leschot, eds. (Rodopi, Amsterdam), pp. 85-152.
54. MARSHALL, E. (1995). Less hype, more biology needed for gene therapy. Science 270, 1751.
55. MARTEAU, T.M., JOHNSTON, M., SHAW, R.W., MICHIE, S., KIDD, J., and NEW, M. (1989). The impact of prenatal screening and diagnostic testing upon the cognitions, emotions, and behavior of pregnant women. J. Psychosomat. Res. 33, 7-15.
56. McCULLOUGH, L.B., and CHERVENAK, F.A. (1994). Ethics in Obstetrics and Gynecology. (Oxford University Press, New York).
57. MAURON, A., and THEVOS, J.M. (1991). Germ-line engineering: A few European voices. J. Med. Philos. 16, 649-667.
58. MILUNSKY, A. (1977). Know Your Genes. (Houghton Mifflin, Boston MA), p. 308.
59. MONTELEONE, P.L., and MORACZEWSKI, A.S. (1981). Medical and ethical aspects of the prenatal diagnosis of genetic disease. In New Perspectives on Human Abortion. T.W. Hilgers et al., eds. (University Publications of America, Frederick, MD), pp. 45-59.
60. MOTULSKY, A.G. (1974). Brave new world. Science 185, 653-663.
61. NATIONAL COMMISSION ON CHILDREN. (1991). Beyond Rhetoric: A New American Agenda for Children and Families. (US Government Printing Office, Washington, DC).
62. NEEL, J.V. (1972). Ethical issues resulting from prenatal diagnosis. In Early Diagnosis of Human Genetic Defects. M. Harris, ed. (U.S. Government Printing Office, Washington, DC, Fogarty International Center, Proceedings No. 6.) HEW publication No. (NIH) 72-25, pp. 219-229.
63. NELSON, L.J., and MILLIKEN, N. (1988). Compelled medical treatment of pregnant women. J. Am. Med. Assn. 259, 1060-1066.
64. NEWACHECK, P.W., HUGHES, D.C., and CISTERNAS, M. (1995) Children and Health Insurance: An Overview of Recent Trends. Health Affairs 14, 244-254.
65. NIRENBERG, M. (1967) Will society be prepared? Science. 157, 633.
66. NOGUCHI, P. (1994). Letter to Nelson A. Wivel, Nov. 3. Cited in Hum. Gene Ther. (1995) 6, 531.
67. PATTERSON, A. (1996). Personal communication, Feb. 12, 1996.
68. PERGAMENT, E., and BONNICKSEN, A. (1994). Preimplantation genetics. A case for prospective action. Am. J. Med. Genet. 52, 151-157.
69. POWLEDGE, T.M., and FLETCHER, J.C. (1979). Guidelines for the ethical, social, and legal issues in prenatal diagnosis. N. Engl. J. Med. 300, 170-178.
70. RAMSEY, P. (1973). Abortion. A review article. Thomist 37, 174-226.
71. ROTHMAN, B.K. (1986). The Tentative Pregnancy. (Viking, New York).
72. SCHROEDER, S.A. (1996). The medically uninsured. Will they always be with us? N. Engl. J. Med. 334, 1130-1133.
73. SCHULMAN, J.L. (1985). Prenatal treatment of biochemical disorders. Sem. Perinat. 9, 75-78.
74. STROM, C.M., and RECHITSKY, S. (1992). DNA analysis of polar bodies and preembryos. In Preimplantation Diagnosis of Genetic Diseases. Y. Verlinsky and A.M. Kuliev, eds. (Wiley-Liss, New York), pp. 69-91.
75. U.S. CONGRESS, OFFICE OF TECHNOLOGY ASSESSMENT. (1987). New Developments in Biotechnology - Background Paper: Public Perceptions of Biotechnology. (U.S. Government Printing Office, Washington, D.C.) OTA-BP-BA-45, pp. 73-74.
76. VERLINSKY, Y., CIESLAK, J., FREIDINE, M., IVAKHNENKO, V., WOLF, G., KOVALINSKAYA, L., WHITE, M., LIFCHEZ, A., KAPLIN, B., MOISE, J., VALLE, J., GINSBERG, N., STROM, C., and KULIEV, A. (1995). Hum. Reprod. 10, 1923-1927.
77. VERMA, I.C., and SINGH, B. (1989). Ethics and medical genetics in India. In Ethics and Human Genetics. A Cross-Cultural Perspective. D.C. Wertz and J.C. Fletcher, eds. (Springer-Verlag, Heidelberg), pp. 250-270.
78. WALTERS, L. (1991). Human gene therapy: ethics and public policy. Hum. Gene Ther. 2, 115-122.
79. WERTZ, D.C., ROSENFELD, J.M., JANES, S.R., et al. (1991). Attitudes toward abortion among parents of children with cystic fibrosis. Am. J. Publ. Health 81, 992-996.
80. WHITE-VAN MOURIK, M.C.A., CONNOR, J.M., and FERGUSON-SMITH, M.A. (1990). Patient care before and after termination of pregnancy for neural tube defects. Prenat. Diagn. 10, 497-503.
81. WIVEL, N.A., and WALTERS, L. (1993). Germ-line gene modification and disease prevention: Some medical and ethical perspectives. Science 262, 533-538.
82. ZANJANI, E.D., SROUR, E.F., and HOFFMAN, R. (1995). Retention of long-term repopulating ability of xenogenic transplanted purified adult human bone marrow hematopoietic stem cells in sheep. J. Lab. Clin. Med. 126, 24-28.