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

38 See, D. N. Irving, "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); 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:, and at [Back]

39 "Testimony of Michael D. West, Ph.D., President & CEO, Advanced Cell Technology, Inc." (July 18, 2001), at: [Back]

40  See, O'Rahilly and Muller (2001); ... the procession of events that begins when a spermatozoon makes contact with a secondary oocyte or its investments, and ends with the intermingling of maternal and paternal chromosomes at metaphase of the first mitotic division of the zygote. The zygote is characteristic of the last phase of fertilization and is identified by the first cleavage spindle. It is a unicellular embryo. (p. 19)

Moore and Persaud (1998): Zygote: This cell results from the union of an oocyte and a sperm. A zygote is the beginning of a new human being (i.e., an embryo). The expression "fertilized ovum" refers to a secondary oocyte that is impregnated by a sperm; when fertilization is complete, the oocyte becomes a zygote. (p. 2)

Larsen (1997): ... [W]e begin our description of the developing human with the formation and differentiation of the male and female sex cells or gametes, which will unite at fertilization to initiate the embryonic development of a new individual. (p. 1)

O'Rahilly and Muller (2001): Although life is a continuous process, fertilization ... is a critical landmark because, under ordinary circumstances, a new, genetically distinct human organism is formed when the chromosomes of the male and female pronuclei blend in the oocyte. (p. 31)

Moore and Persaud (1998): ... The embryo's chromosomes sex is determined at fertilization by the kind of sperm (X or Y) that fertilizes the ovum; hence it is the father rather than the mother whose gamete determines the sex of the embryo. (p. 37); Carlson (1999): The sex of the future embryo is determined by the chromosomal complement of the spermatozoon. (If the sperm contains 22 autosomes and an X chromosome, the embryo will be a genetic female, and if it contains 22 autosomes and a Y chromosome, the embryo will be a male.) ... Through the mingling of maternal and paternal chromosomes, the zygote is a genetically unique product of chromosomal reassortment, which is important for the viability of any species. (p. 32)

O'Rahilly Muller (1994): The embryonic period proper ... occupies the first 8 postovulatory weeks (i.e., timed from the last ovulation) ... The fetal period extends from 8 weeks to birth. (p. 55); Carlson 1994: After the eighth week of pregnancy the period of organogenesis (embryonic period) is largely completed and the fetal period begins. (p. 407)

O'Rahilly and Muller (2001): ... Fertilization takes place normally in the ampulla (lateral end) of the uterine tube. (p. 31); Moore and Persaud (1998): The usual site of fertilization is the ampulla of the uterine tube [fallopian tube], its longest and widest part. If the oocyte is not fertilized here, it slowly passes along the tube to the uterus, where it degenerates and is resorbed. Although fertilization may occur in other parts of the tube, it does not occur in the uterus. ... Human development begins when a oocyte is fertilized. (p. 34); Carlson (1999): "Human pregnancy begins with the fusion of an egg and a sperm, but a great deal of preparation [recedes this event. First both male and female sex cells must pass through a long series of changes (gametogenesis) that convert them genetically and phenotypically into mature gametes, which are capable of participating in the process of fertilization. Next, the gametes must be released from the gonads and make their way to the upper part of the uterine tube, where fertilization normally takes place. ... Finally, the fertilized egg, now properly called an embryo, must make its way into the uterus ... .". (p. 2); ... Fertilization age: dates the age of the embryo from the time of fertilization. (p. 23) ... In the female, sperm transport begins in the upper vagina and ends in the ampulla of the uterine tube [fallopian tube] where the spermatozoa make contact with the ovulated egg. (p. 27); Larsen (1997): In this text, we begin our description of the developing human with the formation and differentiation of the male and female sex cells or gametes, which will unite at fertilization to initiate the embryonic development of a new individual. ... Fertilization takes place in the oviduct [not the uterus]... resulting in the formation of a zygote containing a single diploid nucleus. (p. 1); "These pronuclei fuse with each other to produce the single, diploid, 2N nucleus of the fertilized zygote. This moment of zygote formation may be taken as the beginning or zero time point of embryonic development. (p. 17) [Back]

41 Steven Ertelt, "Doctors Group Assails Stem Cell Research Backer's Cloning Statement", (October 1, 2004), at: [Back]

42 Ibid. [Back]

43 State Bills on Human Cloning: A Report from Americans to Ban Cloning (March 26, 2003), "As in the New Jersey bills, one is only guilty of 'human cloning' if one maintains the cloned human 'through' all stages including the newborn stage. This leaves open the prospect of exploiting cloned embryos, fetuses and even newborn infants for their stem cells". Again, "The current federal bill to allow human cloning for research purposes (S. 303) mandates the destruction of cloned embryos when they are 14 days old. However, biotechnology interests in many states have already dropped this arbitrary time limit to support broader proposals. One possible reason for this: The only successful trials in using cloning to provide therapies for animals have required developing cloned embryos to the fetal stage (to provide kidney tissue for cows) or even to the newborn stage (to correct an immune deficiency in mice) before usable stem cells could be harvested. The new state bills would allow researchers to extend this approach to humans - definitively eliminating the distinction between "therapeutic cloning" and "reproductive cloning" the industry has defended in the past," at See also, Irving invited testimony, "State of New Jersey human cloning 'ban': Legally valid informed consent (November 4, 2002) at:, and at; Irving, "Requested testimony on Canadian Bill C-13 [passed as C-6] ('Assisted Human Reproduction Act')", House of Commons (December 9, 2002), at:, and at; Irving, "State of Delaware human cloning 'ban': Loopholes form blueprints for human genetic engineering (April 14, 2004), at:; and, "State of Louisiana: Two cloning 'bans' would allow extensive human cloning and human genetic engineering" (May 16, 2004), at: [Back]

44 As quoted in, "Stanford Plans Controversial Stem-cell Work", USA Today, Dec. 12, 2002, at: See also, Elizabeth Wiese, Stanford plans controversial stem-cell work, By Elizabeth Wiese, USA Today, Dec. 11, 2002, at: [Back]

45 "Report of the California Advisory Committee on Human Cloning" (Jan. 11, 2002), Sacramento, CA, at [Back]

46 National Academy of Sciences (2002) Scientific and Medical Aspects of Human Reproductive Cloning. National Academy Press, Washington, DC. See excellent article on this ruse by D—nal P. O'Mathœna, ÒWhat to call human cloningÓ, EMBO Reports 3, 6, 502Ð505 (2002), at: [Back]

47 Stem Cells and the Future of Regenerative Medicine (2002) Commission on Life Sciences, at: [Back]

48 Vogelstein, Alberts and Shine, "Please don't call it cloning!", Science, Vol 295, Issue 5558, 1237 , 15 February 2002, at: [Back]

49 Julie Bell and Michael Stroh, "Ethics: Debate surrounds the practice of shifting experiments overseas to circumvent U.S. regulations", The Baltimore Sun, Oct. 17, 2003), at:,0,562356.story?coll=bal-home-headlines. [Back]

50 See several examples from PubMed listed in Irving, "Scientific References, Human Genetic Engineering (Including Cloning): Artificial Human Embryos, Oocytes, Sperms, Chromosomes and Genes" (May 25, 2004), at: See also Irving, "Historic roots of human genetic engineering: REASON, Duke, and parahuman reproduction - 1972" (July 11, 2004), at: [Back]

51 Doctor Jamie Grifo, a leading infertility researcher at New York University, as quoted in Stephen Smith, "Cloning bans could have impact on infertility treatments", Jan. 9, 1998, at [Back]

52 Rick Weiss, "Stem cells an unlikely therapy for Alzheimer's", Washington Post (June 10, 2004), p. A03, at [Back]

53 Irving Weissman, "A Message from the Director of the Institute of Cancer/Stem Cell Biology and Medicine at Stanford", Stanford Report (January 22, 2003), at: [Back]

54 Ibid. [Back]

55 BIO (Biotechnology Industry Organization, "Cloning Patent Fact Sheet: New Patent Legislation Sets Dangerous Precedent And Stifles Research" (Sept. 2, 2003), at: See also, Jim Abrams, "Lawmakers weigh human organism patent ban", Seattle Post-Intelligencer, at: [Back]

56 Peter R. Brinsden, "Regulation of assisted reproductive technology: The UK experience", in Peter R. Brinsden (ed.), A Textbook of In Vitro Fertilization and Assisted Reproduction (2nd ed) (New York: The Parthenon Publishing Group, 1999) [Bourn Hall Clinic, Bourn, Cambridge, UK], p. 421). [Back]

57 Geraedts, J. P., and G. M. de Wert, "Cloning: applications in humans 1. Technical aspects", Ned Tijdschr Tandheelkd. 2001 Apr; 108(4):145-50; PMID: 11383357; [Back]

58 See scientific references on twinning in note 5, supra. [Back]

59 Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (2nd ed.) (New York: John Wiley & Sons, Inc., 1999): A form of animal cloning can also occur as a result of artificial manipulation to bring about a type of asexual reproduction. The genetic manipulation in this case uses nuclear transfer technology: a nucleus is removed from a donor cell then transplanted into an oocyte whose own nucleus has previously been removed. The resulting 'renucleated' oocyte can give rise to an individual who will carry the nuclear genome of only one donor individual, unlike genetically identical twins. The individual providing the donor nucleus and the individual that develops from the 'renucleated' oocyte are usually described as "clones", but it should be noted that they share only the same nuclear DNA; they do not share the same mitochondrial DNA, unlike genetically identical twins. (pp. 508-509) [Back]

60 See, e.g.: (1) Congressional website, Cloning Basics: 101: "What is Cloning?" ... It is false to say that cloning solves the transplant rejection problem. Each embryo clone would still contain mitochondrial DNA from the egg donor; the clone is NOT an exact genetic copy of the nucleus donor, and its antigens would therefore provoke immune rejection when transplanted. There would still be the problem of immunological rejection that cloning is said to be indispensable for solving," at (2) "Congressman Weldon's Cloning Facts", quoting testimony of Dr. Irving Weissman before the President's Council on Bioethics, "I should say that when you put the nucleus in from a somatic cell, the mitochondria still come from the host" [from the female egg] ... And in mouse studies it is clear that those genetic differences can lead to a mild but certainly effective transplant rejection and so immunosuppression, mild though it is, will be required for that", at; also at: (3) Transcript of House Hearing introducing Weldon Bill, Cliff Stearns (FL) testimony before Hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, 107th Congress, 1st Session on H.R. 1644 and H.R. 2172 (June 20, 2001), "Seven States' proposals ban the creation of genetically identical individuals, but that leaves another loophole. An egg cell, donated for cloning, has its own mytochondrial DNA, which is different from the mytochondrial DNA of the cell that provided the nucleus. The clone will, therefore, not truly be identical", at: (4) Senator Sam Brownback, "Some proponents of human cloning claim that an embryo created in this manner will have cells that are a genetic match to the patient being cloned, and thus would not be rejected by the patient's immune system. This claim is overstated at best; in fact there are some scientific reports that show the presence of mitochondrial DNA in the donor egg can trigger an immune-response rejection in the patient being treated, in "A True Complete Ban", National Review Online, Feb. 26, 2003, at: (5) Leon Kass, "Before one starts arguing the morality of embryo farming, we should know that the whole matter is science fiction. The egg containing my nucleus is not fully my genetic twin. It also contains residual DNA -- mitochondrial DNA -- from the woman who donated the egg. The cloned embryo and all cells derived from it remain partly 'foreign,' enough to cause transplant rejection", in The Chicago Tribune, July 31, 2001, quoted by Dave Andrusko in, "Averting a Catastrophe", at: (6) President's Council on Bioethics, "The technique of cloning ... bring to live birth a cloned animal that is genetically virtually identical (except for the mitochondrial DNA) to the animal that donated the adult cell nucleus", in Human Cloning and Human Dignity: An Ethical Inquiry, "Executive Summary; Fair and Accurate Terminology; Scientific Background", at: (7) George Annas, "How could such stem-cell lines be generated? One way is by transferring somatic-cell nuclei into enucleated eggs (nuclear transplantation). When stimulated to divide, the cell can form blastocysts of predefined nuclear genotype (with the mitochondrial DNA coming from the egg)", The New England Journal of Medicine, Volume 346:1576-1579 May 16, 200, "Stem Cells Scientific, Medical, and Political Issues", at: [emphases added] [Back]


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