Analysis of Legislative and Regulatory Chaos in the U.S.: Asexual Human Reproduction and Genetic Engineering


15 See Irving, Comments: 'Review: Blueprint for the Earth - and Junk Physicists'" (Sept.5, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_41blueprint.html. [Back]

16 Open Encyclopedia, at: http://open-encyclopedia.com/Organism; also Wikipedia, at: http://en.widipedia.org/wiki/Organism. [Back]

17 Open Encyclopedia, at: http://open-encyclopedia.com/Cell_(biology). [Back]

18 Keith Moore and T. V. N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. only) (Philadelphia: W.B. Saunders Company, 1998), p. 18. [Back]

19 William J. Larsen, Human Embryology (New York: Churchill Livingstone, 1997), p. 1. [Back]

20 Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 2001), p. 87. [Back]

21 For a scientific explanation (with extensive scientific references) of the role of "regulation" in both sexual and asexual reproduction, see Irving, "Playing God by manipulating man: Facts and frauds of human cloning" (October 4, 2003), presented twice at the Missouri Catholic Conference Annual Assembly Workshop, Jefferson City, MO, at: http://www.mocatholic.org/uploads/IrvingCloning3.pdf, and at http://www.lifeissues.net/writers/irv/irv_22manipulatingman1.html; see also "Stem cells that could become embryos: Implications for the NIH Guidelines on stem cell research, the NIH stem cell report, informed consent, and patient safety in clinical trials" (July 22, 2001); written as consultant on human embryology and human embryo research as Fellow of The Linacre Institute (CMA), The Catholic Medical Association (USA), and The International Federation of Catholic Medical Associations (FIAMC), at: http://www.lifeissues.net/writers/irv/irv_39anlystemcel1.html. [Back]

22 Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 2001), p. 31. [Back]

23 Ibid., p. 88. [Back]

24 Ibid, p. 98. [Back]

25  See the development of the erroneous term "pre-embryo" in the early works of, e.g., Richard McCormick, S.J., "Who or what is the preembryo?", Kennedy Institute of Ethics Journal 1:1 (1991). In this paper McCormick draws heavily on the work of frog embryologist Clifford Grobstein, as well as from "an unpublished study of a research group of the Catholic Health Association entitled 'The Status and Use of the Human Preembryo', (p. 14).

The influence of the McCormick/Grobstein term "pre-embryo" was (and still is) widespread even among Catholic scholars. In addition to the works of McCormick and Grobstein, see acceptance of the term "pre-embryo" also in: Andre E. Hellegers, "Fetal development," in Thomas A. Mappes and Jane S. Zembatty (eds.), Biomedical Ethics, (New York: Macmillan, 1981); Hellegers, "Fetal development", Theological Studies (1970), 31:3-9; Charles E. Curran, "Abortion: Contemporary debate in philosophical and religious ethics", in W. T. Reich (ed.), Encyclopedia of Bioethics 1 (London: The Free Press, 1978), pp. 17-26; Kevin Wildes, "Book Review: Human Life: Its Beginning and Development" (L'Harmattan, Paris: International Federation of Catholic Universities, 1988); Carlos Bedate and Robert Cefalo, "The zygote: To be or not be a person", Journal of Medicine and Philosophy (1989), 14:6:641; Robert C. Cefalo, "Book Review: Embryo Experimentation, Peter Singer et al (eds.); 'Eggs, embryos and ethics'", Hastings Center Report (1991), 21:5:41; Mario Moussa and Thomas A. Shannon, "The search for the new pineal gland: Brain life and personhood", The Hastings Center Report (1992), 22:3:30-37; Carol Tauer, The Moral Status of the Prenatal Human (Doctoral Dissertation in Philosophy; Kennedy Institute of Ethics, Georgetown University, Washington, D.C.: Georgetown University, 1981) (Sister Tauer's dissertation mentor was Richard McCormick; she later went on to become the ethics co-chair of the NIH Human Embryo Research Panel 1994); C. Tauer, "The tradition of probabilism and the moral status of the early embryo", in Patricia B. Jung and Thomas A. Shannon, Abortion and Catholicism (New York: Crossroad, 1988), pp. 54-84; Lisa S. Cahill, "Abortion, autonomy, and community", in Jung and Shannon, Abortion and Catholicism (1988), pp. 85-98; Joseph F. Donceel, "A liberal Catholic's view", in Jung and Shannon, Abortion and Catholicism (1988), pp. 48-53; H. Tristram Engelhardt, The Foundations of Bioethics (New York: Oxford University Press, 1985), p. 111; William A. Wallace, "Nature and human nature as the norm in medical ethics", in Edmund D. Pellegrino, John P. Langan and John Collins Harvey (eds.), Catholic Perspectives on Medical Morals (Dordrecht: Kluwer Academic Publishing, 1989), pp. 23-53; Norman Ford, When Did I Begin? (New York: Cambridge University Press, 1988), p. 298; Antoine Suarez, "Hydatidiform moles and teratomas confirm the human identity of the preimplantation embryo", Journal of Medicine and Philosophy (1990), 15:627-635; Thomas J. Bole, III, "Metaphysical accounts of the zygote as a person and the veto power of facts", Journal of Medicine and Philosophy (1989), 14:647-653; Bole, "Zygotes, souls, substances, and persons", Journal of Medicine and Philosophy (1990), 15:637-652.

See also: See Richard McCormick's testimony in The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Report and Recommendations; Research on the Fetus; U.S. Department of Health, Education and Welfare, 1975, pp. 34-35; McCormick, How Brave a New World? (Washington, D.C.: Georgetown University Press), p. 76; McCormick, "Proxy consent in the experimentation situation", Perspectives in Biology and Medicine (1974), 18:2-20; Paul Ramsey's testimony in The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Report and Recommendations; Research on the Fetus; U.S. Department of Health, Education and Welfare, 1975, pp. 35-36.

The use of the term "pre-embryo" has been quite widespread for decades -- nationally and internationally. In addition to the Catholic scholars who accepted the use of the term "pre-embryo" as noted above, a partial list of secular bioethics writers who also accepted the use of the term in these debates includes: Paul Ramsey, "Reference points in deciding about abortion" in J.T. Noonan (ed.), The Morality of Abortion (Cambridge, MA: Harvard University Press, 1970), pp. 60-100, esp. p. 75; John Robertson, "Extracorporeal embryos and the abortion debate", Journal of Contemporary Health Law and Policy (1986), 2;53;53-70; Robertson, "Symbolic issues in embryo research", The Hastings Center Report (1995, Jan./Feb.), 37-38; Robertson, "The case of the switched embryos", The Hastings Center Report (1995), 25:6:13-24; Howard W. Jones, "And just what is a preembryo?", Fertility and Sterility 52:189-91; Jones and C. Schroder, "The process of human fertilization: Implications for moral status", Fertility and Sterility (August 1987), 48:2:192; Clifford Grobstein, "The early development of human embryos", Journal of Medicine and Philosophy (1985), 10:213-236; also, Science and the Unborn (New York: Basic Books, 1988), p. 61; Michael Tooley, "Abortion and infanticide", in The Rights and Wrongs of Abortion, M. Cohen et al (eds.) (New Jersey: Princeton University Press, 1974), pp. 59 and 64; Peter Singer and Helga Kuhse, "The ethics of embryo research", Law, Medicine and Health Care (1987),14:13-14; Kuhse and Singer, "For sometimes letting - and helping - die", Law, Medicine and Health Care (1986), 3:40:149-153; Kuhse and Singer, Should The Baby Live? The Problem of Handicapped Infants (Oxford University Press, 1985), p.138; Singer, "Taking life: Abortion", in Practical Ethics (London: Cambridge University Press, 1981), pp. 122-123; Peter Singer, Helga Kuhse, Stephen Buckle, Karen Dawson, Pascal Kasimba (eds.), Embryo Experimentation (New York: Cambridge University Press, 1990); R.M. Hare, "When does potentiality count? A comment on Lockwood," Bioethics (1988), 2:3:214; Michael Lockwood, "When does life begin?", in Michael Lockwood (ed.), Moral Dilemma's in Modern Medicine (New York: Oxford University Press, 1985), p. 10; Hans-Martin Sass, "Brain life and brain death: A proposal for normative agreement," Journal of Medicine and Philosophy (1989), 14:45-59; Michael Lockwood, "Warnock versus Powell (and Harradine): When does potentiality count?" Bioethics (1988), 2:3:187-213.

See also the use of the term "pre-embryo" in many national and international documents (a small sample): Ethics Advisory Board (1979) Report and Conclusions: HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer, Washington, D.C.: United States Department of Health, Education and Welfare, p. 101; National Institutes of Health Human Embryo Research Panel Meetings (Washington, D.C.: NIH, 1994), Feb. 2 meeting, pp. 27, 31, 50-80, 85-87, 104-106; in the Feb. 3, 1994 meeting, pp. 6-55; April 11 meeting, pp. 23-41, 9-22. See also, Dame Mary Warnock, Report of the Committee of Inquiry into Human Fertilization and Embryology, (London: Her Majesty's Stationary Office, 1984), pp. 27 and 63; British House of Lords, "Human Fertilisation and Embryology (Research Purposes) Regulations 2001"; Commonwealth of Australia, Select Senate Committee on the Human Embryo Experimentation Bill, (Canberra, Australia: Official Hansard Report, Commonwealth Government Printer, 1986); Parliamentary Assembly of the Council of Europe, On the Use of Human Embryos and Foetuses for Diagnostic, Therapeutic, Scientific, Industrial and Commercial Purposes, Recommendation 1046, 1986; and On the Use of Human Embryos and Foetuses in Scientific Research, Recommendation 1000, 1989; Ethics Committee of the American Fertility Society (AFS), "Ethical Considerations of the New Reproductive Technologies", Fertility and Sterility (1986), 46:27S. See also Jonsen, esp. Chapters 4 and 12. [Back]

26  For scientific refutations of the false term "pre-embryo" and its "pre-embryo substitutes", see, e.g., articles by C. Ward Kischer, a Ph.D. human embryologist who has taught human embryology for over 30 years: "Stem cell research, Ron Reagan, and John Kerry", http://www.lifeissues.net/writers/kisc/kisc_07cellsearchkerry.html; "Why Hatch is wrong on human life", http://www.lifeissues.net/writers/kisc/kisc_06whywrong.html; "The corruption of the science of Human Embryology", http://www.lifeissues.net/writers/kisc/kisc_01humanembryology.html; "There is no such thing as a pre-embryo", http://www.lifeissues.net/writers/kisc/kisc_05nopreembryo.html; "Cloning, stem cell research, and some historic parallels, http://www.lifeissues.net/writers/kisc/kisc_02historicparallels.html; "The beginning of life and the establishment of the continuum", in Kischer and Irving, The Human Development Hoax: Time To Tell The Truth!, (Clinton Township, MI: Gold Leaf Press, 1995 and extensively revised and expanded second edition by co-authors (1997), pp. 4-13; "When Does Human Life Begin? The Final Answer -- A human embryologist speaks out about socio-legal issues involving the human embryo". See also article by Sarah Sexton, "New Reproductive and Genetic Technologies: International versus National Campaign Issues", in The Geneticization of Health (p. 8), presentation to International IPPNW (International Physicians for the Prevention of Nuclear War)-Kongress Medizin und Gewissen (Medicine and Conscience), Erlangen, Germany, 24-27 May 2001, http://www.thecornerhouse.org.uk/document/medcon.html.

See also Irving articles refuting both scientifically and philosophically the false term "pre-embryo" indexed at PubMed: "NIH and human embryo research revisited: what is wrong with this picture?", Linacre Q. 2000 May ;67(2):8-22, PMID: 11817406, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11817406; "'New age' embryology text books: 'Pre-embryo', 'pregnancy' and abortion counseling: Implications for fetal research", Linacre Quarterly May 1994, 61(2):42-62, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652337; "Testimony before the NIH Human Embryo Research Panel", Linacre Q. 1994 Nov;61(4):82-9, PMID: 11652834, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652834; "Quality assurance auditors: how to survive between a rock and a hard place", Qual Assur. 1994 Mar;3(1):33-52, PMID: 7804617, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=7804617; "The impact of "scientific misinformation" on other fields: philosophy, theology, biomedical ethics, public policy", Account Res. 1993;2(4):243-72, PMID: 11652144, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652144; "Which ethics for science and public policy?", Account Res. 1993;3(2-3):77-100, PMID: 11652298, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652298. All of these articles are also accessible in full on-line at http://www.lifeissues.net/section.php?topic=ir.

See also, Irving: "Fake Science and Scary Ethics of Cloning" (August 24, 2004), British Medical Journal Rapid Response to "Book Review: A Clone of Your Own? The Science and Ethics of Cloning", by Trefor Jenkins, http://bmj.bmjjournals.com/cgi/eletters/329/7463/466#71990; "The Kettles calling the Pots fake: "When is cloning not 'cloning'?"; When both sides play politics -- with human lives" (July 27, 2004), http://www.lifeissues.net/writers/irv/irv_63kettle1.html; "Playing God by manipulating man: Facts and frauds of human cloning", http://www.mocatholic.org/uploads/IrvingCloning3.pdf, and http://www.lifeissues.net/writers/irv/irv_22manipulatingman1.html; "A ONE ACT PLAY: The early human embryo: 'Scientific' myths / scientific facts: Implications for ethics and public policy", Medicine and Human Dignity's International Bioethics Conference: 'Conceiving the embryo', Brussels, Belgium (October 20, 2002), (in press, and CD-Rom), http://www.cfjd.org/www/articles/the_early_human_embryo.htm, and http://www.lifeissues.net/writers/irv/irv_11oneactdrama1.html; "Requested testimony on Canadian Bill C-13 ('Assisted Human Reproduction Act')", House of Commons (December 9, 2002), http://www.lifeissues.net/writers/irv/irv_16canadianbill.html, and http://www.clcns.com/Action%20Items.htm; "Analysis: Canadian Bill C-56", http://www.lifesite.net/features/stemcellembryo/irvingcritiquebillc56.pdf, and http://www.clcns.com/Action%20Items.htm; "Analysis: Stem cells that could become embryos: Implications for the NIH Guidelines on stem cell research, the NIH stem cell report, informed consent, and patient safety in clinical trials" (July 22, 2001), http://www.lifeissues.net/writers/irv/irv_39anlystemcel1.html; "University Faculty for Life: Submission of Concern to the Canadian CIHR Re the 'Human Stem Cell Research Recommendations 2001'", submitted to Dr. Alan Bernstein, President, Canadian Institutes of Health Research Working Group on Stem Cell Research, Ottawa, Ontario, Canada (June 3, 2001), at: http://www.uffl.org/irving/irvcihr.htm, and http://www.lifeissues.net/writers/irv/irv_60canadiancihrrecomm1.html; "University Faculty for Life: Letter of Concern to Sen. Brownback and Congressman Weldon Re the 'Human Cloning Bill 2001'", (May 27, 2001), at: http://www.lifeissues.net/writers/irv/irv_52weldonbrownback1.html, http://www.uffl.org/irving/irvbrownback.htm; "University Faculty for Life: Submission of Concern to the British House of Lords Re the 'Human Fertilisation and Embryology (Research Purposes) Regulations 2001' submitted to Tony Rawsthorne,Select Committee, House of Lords, London (June 1, 2001), http://www.parliament.the-stationeryoffice.co.uk/pa/ld200102/ldselect/ldstem/83/8313.htm (acknowledgment), and http://www.uffl.org/irving/irvlords.htm (full text); "When does a human being begin? 'Scientific' myths and scientific facts", International Journal of Sociology and Social Policy, 1999, 19:3/4:22-47, http://www.l4l.org/library/mythfact.html, and http://www.lifeissues.net/writers/irv/irv_01lifebegin1.html; "UFL submission to NBAC Report: Research Involving Human Biological Materials: Ethical Issues and Policy Guidance", VOLUME I Report and Recommendations of the National Bioethics Advisory Commission Rockville, Maryland August 1999 The National Bioethics Advisory Commission (NBAC), acknowledged Appendix E, p. 111; Invited Congressional testimony (oral and written), "The immediate product of human cloning is a human being: Claims to the contrary are scientifically wrong", Scientific Panel on "Cloning: Legal, Medical, Ethical, and Social Issues", Hearing before the Subcommittee on Health and Environment of the Committee on Commerce, U.S. House of Representatives, Room 2125, Rayburn House Office Building, Washington, D.C. (February 12, 1998); also in Linacre Quarterly (May 1999), 66:2:26-40, http://www.lifeissues.net/writers/irv/irv_09cloninghuman1.html; "Cloning: When word games kill", (May 13, 1998), at: http://www.lifeissues.net/writers/irv/irv_06wordgame.html; "Academic fraud and conceptual transfer in bioethics: Abortion, human embryo research and psychiatric research", in Joseph W. Koterski (ed.), Life And Learning IV (Washington, D.C.: University Faculty for Life, 1995), pp. 193-215, http://www.lifeissues.net/writers/irv/irv_10fraud1.html, and http://govinfo.library.unt.edu/nbac/hbm.pdf; "Scientific and philosophical expertise: An evaluation of the arguments on 'personhood'", Linacre Quarterly February 1993, 60:1:18-46, http://www.lifeissues.net/writers/irv/irv_04person1.html; and Irving doctoral dissertation on this issue, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (Doctoral dissertation, Georgetown University, Washington, D.C., 1991). [Back]

27 Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 2001), p. 88. [Back]

28 See, D. N. Irving, "University Faculty for Life: Submission of Concern to the British House of Lords Re the 'Human Fertilisation and Embryology (Research Purposes) Regulations 2001'"; written as UFL Board Member on behalf of UFL; submitted to Tony Rawsthorne, Select Committee, House of Lords, London (June 1, 2001), at: http://www.parliament.thestationeryoffice.co.uk/pa/ld200102/ldselect/ldstem/83/8313.htm (acknowledgment), and at http://www.uffl.org/irving/irvlords.htm (full text). [Back]

29 Dame Mary Warnock, Report of the Committee of Inquiry into Human Fertilization and Embryology (London: Her Majesty's Stationary Office, 1984), p. 17; National Institutes of Health: Report of the Human Embryo Research Panel (Washington, D.C.: NIH, Sept. 27, 1994), pp. 45ff. [Back]

30 Sarah Sexton, "What's In A Name?", Briefing No. 16: The Geneticisation of Health (October 1999), p. 8, http://www.thecornerhouse.org.uk/pdf/briefing/16clone.pdf. [Back]

31 See, e.g., the older OPRR federal regulations and the current OHRP federal regulations for the use of human subjects in research, analyzed below. The regulation of any human cloning or human genetic engineering will most likely be accomplished by these federal regulations, including the use of IRB's established to enforce them. [Back]

32 E.g., ÒCalifornia should regulate all human nonreproductive cloning in the State ... That regulation should do at least three things: a) prohibit the use of pre-embryos after development of the primitive streak ...Ó, in Cloning Californians? Report of the California Advisory Committee on Human Cloning (January II, 2002), at: http://scbe.stanford.edu/conference/cloning_cali.pdf. For the State of California cloning law (SB-1230, Jan. 7, 2002) see http://info.sen.ca.gov/pub/0102/bill/sen/sb_12011250/sb_1230_bill_20020923_chaptered.html. For their human embryonic stem cell research law (SB-253, Feb. 15, 2001), see http://info.sen.ca.gov/pub/0102/bill/sen/sb_02510300/sb_253_bill_20020922_chaptered.html [Back]

33 See, D. N. Irving, "University Faculty for Life: Submission of Concern to the Canadian CIHR Re the 'Human Stem Cell Research Recommendations 2001'"; written as UFL Board Member on behalf of UFL; submitted to Dr. Alan Bernstein, President, Canadian Institutes of Health Research Working Group on Stem Cell Research, Ottawa, Ontario, Canada (June 3, 2001), at: http://www.uffl.org/irving/irvcihr.htm, and at http://www.lifeissues.net/writers/irvi/irvi_06recommendations1.html. For detailed analyses of the Canadian Bill C-6 (and its predecessor Bill C-56), see Irving, "Requested testimony on Canadian Bill C-13 ('Assisted Human Reproduction Act')", House of Commons (December 9, 2002), at: http://www.lifeissues.net/writers/irv/irv_16canadianbill.html; "Canadian Bill C-13: Commentators in Denial, Bill C-13" (Dec 17, 2001), at: http://www.lifeissues.net/writers/irv/irv_17commentatorsindenial.html; Canadian radio interview, "Is 'C-13' a good bill for Canadians?" (Oct 29, 2003), at: http://www.davesturgeon.com/today.php?showid=2719; Analysis: "Canadian Bill C-56", at: http://www.lifesite.net/features/stemcellembryo/irvingcritiquebillc56.pdf. [Back]

34 Ibid., p. 16. [Back]

35 See, Edward J. Furton and Micheline M. Mathews-Roth, "Stem Cell Research and the Human Embryo, Part One", Ethics & Medics (August, 1999). [Back]

36 See Dr. Varmus' 1999 testimony on the NIH website at: http://stemcells.nih.gov/fedPolicy/statement.asp. [Back]

37 See Irving, "Reading the Singer on 'bestiality'", (Feb. 8, 2004), at: http://www.lifeissues.net/writers/irv/irv_23singerglobalethics.html; also, "Stem cell research: Reductio ad Michael Kinsley" (September 20, 2000), at: http://www.lifeissues.net/writers/irv/irv_28reductioadkinsley.html. [Back]

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