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


8  For a lengthy report on the U.S.'s efforts towards the new field, see Converging Technologies for Improving Human Performance: Nanotechnology, Biotechnolog, Information Technology and Cognitive Science, NSF/DOC - sponsored report, edited by Mihail C. Roco and William Sims Bainbridge, National Science Foundation, and the U.S. Dept. of Commerce (June 2002), at: http://wtec.org/ConvergingTechnologies/Report/NBIC_report.pdf.

For those who are still unaware, there are already National Institutes of Nanotechnology in over 40 different countries, including the United States. Such cloning, using "artificially constructed" chromosomes, sperms, oocytes, and embryos, is included in the current New Zealand bill on human artificial reproductive technologies (HART Bill): "gamete means -- (a) an egg or a sperm, whether mature or not; or (b) any other cell (whether naturally occurring or artificially formed or modified) that -- (i) contains only 1 copy of all or most chromosomes; and (ii) is capable of being used for reproductive purposes." http://www.justice.govt.nz/pubs/other/pamphlets/2003/hart/Supp_order_paper.pdf.

The term "reprogenetics" is coined in a recent "Special Supplement" of The Hastings Center Report (July/August 2003) at: (http://www.thehastingscenter.org/news/features/repro%20supplement.pdf), the first sentence of which refers to reprogenetics as "one big embryo experiment". The term refers collectively to the converging of several scientific technologies, especially multiple artificial human reproductive techniques (e.g., IVF and cloning) and human genetics research - other wise known as eugenics. The term is similar to such others as "trans-humanism", "post-humanism", "futurism", etc. - i.e., the remaking of human nature by the use of experimental reproductive and genetic techniques. Such are the stated goals of "nano/bio/info/cogno", supported by this government and many internationally popular "futuristic" programs, e.g., see Converging Technologies for Improving Human Performance (National Science Foundation, and the U.S. Dept. of Commerce, June 2002); you can find the report at: http://itri.loyola.edu/ConvergingTechnologies/Report/NBIC pre publication.pdf (or at http://www.wtec.org/reports.htm). See also, for example, the current New Zealand cloning bill, which defines a "gamete" as including "any other cell (whether naturally occurring or artificially formed or modified) that contains only 1 copy of all or most chromosomes; and is capable of being used for reproductive purposes." [Human Assisted Reproductive Technology Bill: Supplementary Order Paper [HART SOP], April 2003, at http://www.justice.govt.nz/pubs/other/pamphlets/2003/hart/Supp_order_paper.pdf.]

See also recent legal analysis of "nanocloning": [addendum 6-3-04] "Nanotechnology can be used to clone machines as well as living creatures. Issues similar to those currently plaguing policy makers about biological cloning need to be raised early in the life of nanotechnology. ... Proponents of nanotechnology postulate a world where DNA strands can be custom built by repairing or replacing sequences in existing strands of DNA or even by building the entire strand, from scratch, one sequence at a time. With enough nanorobots working quickly enough, one could build a DNA strand that will produce a perfect clone. The same issues will arise, or re-arise, if nanotechnology is successful in promoting cloning of DNA segments, cells, organs, or entire organisms.

See also: "... It is likely that nanotechnology's efforts will lead to twists in the assumptions that lead to the resolution of cloning issues in terms of genetic bioengineering. Policy makers should anticipate, now, that in setting the boundaries for bioengineered cloning, the need to foresee issues that will arise from cloning by nanotechnology and be ready to reevaluate cloning regulation before nanotechnology perfects its own methods of cloning. If we do not anticipate the nanotechnology problems, the debate will emerge in an environment like the current one: one filled with a frenzy and uproar, rather than in an atmosphere of reflection and deliberateness." [Joel Rothstein Wolfson, "Social and Ethical Issues in Nanotechnology: Lessons from Biotechnology and Other High Technologies", 22 Biotechnology Law Report 376, No. 4 (August 2003), pp. 13-14; at: http://www.blankrome.com/publications/Articles/WolfsonNanotechnology.pdf.] [Back]

9 For an interesting and informative book on the formal "birth" of bioethics, written by one of the 11 National Commissioners, see Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998). See a similar "history", focusing more on the research rather than the medical issues, see David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: BasicBooks; a subsidiary of Perseus Books, L.L.C., 1991). For a brief history of the "birth" of bioethics, and an evaluation of its ethical principles, see D. Irving, "What is 'bioethics'?", UFL Proceedings of the Conference 2000, in Joseph W. Koterski (ed.), Life and Learning X: Proceedings of the Tenth University Faculty For Life Conference (Washington, D.C.: University Faculty For Life, 2002), pp. 1-84, at: http://www.lifeissues.net/writers/irv/irv_36whatisbioethics01.html, and http://www.uffl.org/irving/irvwhatisbio.htm. For a shorter version, see Irving, "The bioethics mess", Crisis Magazine, Vol. 19, No. 5, May 2001, at: http://www.catholic.net/rcc/Periodicals/Crisis/2001-05/irving.html, and http://www.lifeissues.net/writers/irv/irv_37bioethicsmess.html. See also Irving, "Which ethics for science and public policy?", Accountability in Research 1993, 3(2-3):77-99, at http://www.lifeissues.net/writers/irv/irv_42whichethics1.html. [Back]

10 Quoted in Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), pp. 109-110. [Back]

11 Tristram Engelhardt, Jr., "The new genetic technologies: ... ", Rev Rom Bioet. 2003 Jan-Mar;1(1):23-30; PMID: 15011667; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15011667. It is, indeed, startling to hear this from one of the founders of bioethics himself, who proffered the following definitions of "person" and "the principle of ownership": "Persons in the strict sense are moral agents who are self-conscious, rational, and capable of free choice and of having interests. This includes not only normal adult humans, but possibly extraterrestrials with similar powers." [H. Tristram Engelhardt, Jr., "Viability and the Use of the Fetus", in Tom L. Beauchamp and Terry P. Pinkard (eds.), Ethics and Public Policy: An Introduction to Ethics (Englewood Cliffs, NJ: Prentice-Hall, Inc., 1983, pp. 299-230; reprinted from W.B. Bondeson, H. Tristram Engelhardt, Jr., S. F. Spicker, and Daniel Winship (eds.), Abortion and the Status of the Fetus (Dordrecht, Holland: Reidel Publishing Company, 1982)]. Again from Engelhardt: "... It is for these reasons that the value of zygotes, embryos, and fetuses is to be primarily understood in terms of the values they have for actual persons. Zygotes, fetuses, and embryos do not have the rich inward life of adult mammals. ... However, one must remember that the sentience of a zygote, embryo, or fetus is much less than that of an adult mammal. One might even develop a suggestion of the natural theologian Charles Hartshorne so as to argue that from the perspective of the Deity the intrinsic value of a human fetus will be less than that of an adult normal member of some other mammalian species. (pp. 112-113). ... One also owns what one produces. One might think here of both animals and young children. Insofar as they are the products of the ingenuity or energies of persons, they can be possessions. There are, however, special obligations to animals by virtue of the morality of beneficence that do not exist with regard to things. Such considerations, as well as the fact that young children will become persons, limit the extent to which parents have ownership rights over their young children. However these limits will be very weak with regard to ownership rights in human zygotes, embryos, and fetuses that will not be allowed to develop into persons, or with regard to lower vertebrates, where there is very little sentience. For example, it would appear very plausible that plants, microbes, and human zygotes can be fashioned as products, and be bought and sold as if they were simply things. In contrast, strong claims of ownership would cease, as children become persons and sui juris, self-possessing. This latter moral issue also arises with regard to normal adult non-human higher primates. It is much more plausible to suspect that higher non-human primates are in possession of themselves than to suspect that such is the case with even one-year-old human infants. At the point that an entity becomes self-conscious, the morality of mutual respect would alienate the property rights of the parents over the children or other animals (129-130). ... These reflections can be encapsulated in what one may term the principle of ownership. This principle will be central to understanding the roles of public and private funding in health care, as well as the rights of physicians to exempt themselves from the constraints of national health services. Owning private property, insofar as such private ownership exists, will always permit patients merely to buy around the established system. So, too, having the right to own one's talents will permit physicians to sell around the constraints of the system. This can be tendentiously summarized as the basic right of persons to the black market." [H. Tristram Engelhardt, Jr., The Foundations of Bioethics (New York: Oxford University Press, 1986).] [Back]

12 Jeffrey Kahn, "What's at issue in the stem cell research debate?", Bioethics Examiner (Spring 2004), Vol. 8, Issue 1, p. 1 and 5. [Back]

13  For extensive scientific references in concert with the international nomenclature documenting that the immediate product of sexual human reproduction (fertilization) is a new living human being, see D. Irving, ""When does a human being begin? 'Scientific' myths and scientific facts", International Journal of Sociology and Social Policy (Feb.1999), 19:3/4:22-47, at: http://isacco.emeraldinsight.com/vl=8997774/cl=38/nw=1/rpsv/cgibin/linker?ini=emerald&reqidx=/cw/mcb/0144333x/v19n3/s4/p22 (subscription); at http://www.l4l.org/library/mythfact.html, and at http://www.lifeissues.net/writers/irv/irv_01lifebegin1.html.

Specifically: Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (3rd ed.)(New York: Wiley-Liss, 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. This remains true even though the embryonic genome is not actually activated until 2-8 cells are present at about 2-3 days. ... During the embryonic period proper, milestones include fertilization, activation of embryonic from extra-embryonic cells, implantation, and the appearance of the primitive streak and bilateral symmetry. ... Fertilization is 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. ... Fertilization takes place normally in the ampulla (lateral end) of the uterine tube. (p. 31); ... The zygote ... is a unicellular embryo and is a highly specialized cell. (p. 33); ... [I]t is now accepted that the word embryo, as currently used in human embryology, means 'an unborn human in the first 8 weeks' from fertilization. Embryonic life begins with the formation of a new embryonic genome (slightly prior to its activation). (p. 87)

Keith Moore and T. V. N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. only) (Philadelphia: W.B. Saunders Company, 1998): Human development is a continuous process that begins when an oocyte (ovum) from a female is fertilized by a sperm (or spermatozoon) from a male. (p. 2); ... but the embryo begins to develop as soon as the oocyte is fertilized. (p. 2); ... 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). (p. 2); ... Human development begins at fertilization, the process during which a male gamete or sperm ... unites with a female gamete or oocyte ... to form a single cell called a zygote. This highly specialized, totipotent cell marks the beginning of each of us as a unique individual. (p. 18); ... Human development begins when a oocyte is fertilized. Fertilization ... begins with contact between a sperm and a oocute and ends with the intermingling of maternal and paternal chromosomes ... of the zygote, a unicellular embryo. (p. 34) ... The zygote is genetically unique because half of its chromosomes come from the mother and half from the father. (p. 37)

Bruce Carlson, Human Embryology & Developmental Biology (St. Louis, MO: Mosby, 1999): "Human pregnancy begins with the fusion of an egg and a sperm, but a great deal of preparation precedes this event. ... Finally, the fertilized egg, now properly called an embryo, must make its way into the uterus ....". (p. 2).

William Larsen, Human Embryology (New York: Churchill Livingstone, 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. Embryonic development is considered to begin at this point. (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).

For extensive scientific references documenting that the immediate product of asexual human reproduction (fertilization) is a new living human being, see D. Irving, "Playing God by manipulating man: Facts and frauds of human cloning" (October 4, 2003), 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. Specifically: Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (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. ... Nuclear transfer technology was first employed in embryo cloning, in which the donor cell is derived from an early embryo, and has been long established in the case of amphibia. ... Wilmut et al (1997) reported successful cloning of an adult sheep. For the first time, an adult nucleus had been reprogrammed to become totipotent once more, just like the genetic material in the fertilized oocyte from which the donor cell had ultimately developed.... Successful cloning of adult animals has forced us to accept that genome modifications once considered irreversible can be reversed and that the genomes of adult cells can be reprogrammed by factors in the oocyte to make them totipotent once again. (pp. 508-509)

This fact is admitted even by those who advocate human cloning. For example, Ian Wilmut: "The majority of reconstructed embryos were cultured in ligated oviducts of sheep... Most embryos that developed to morula or blastocyst after 6 days of culture were transferred to recipients and allowed to develop to term," etc. [I. Wilmut et al., "Viable offspring derived from fetal and adult mammalian cells," 385 Nature 810-813 (Feb. 27, 1997)], and also, "One potential use for this technique would be to take cells -- skin cells, for example -- from a human patient who had a genetic disease... You take these and get them back to the beginning of their life by nuclear transfer into an oocyte to produce a new embryo. From that new embryo, you would be able to obtain relatively simple, undifferentiated cells, which would retain the ability to colonize the tissues of the patient." - Ian Wilmut, in 7 Cambridge Quarterly of Healthcare Ethics 138 (Spring 1988).

On being asked in an interview: "Do you think that society should allow cloning of human embryos because of the great promise of medical benefit?"]: "Yes. Cloning at the embryo stage -- to achieve cell dedifferentiation -- could provide benefits that are wide ranging..." - Keith Campbell, head of embryology at PPL Therapeutics and co-author of Dr. Wilmut's landmark paper, in 7 Cambridge Quarterly of Healthcare Ethics 139 (Spring 1988).

Lee M. Silver, professor of molecular biology and evolutionary biology at Princeton University, "Yet there is nothing synthetic about the cells used in cloning... The newly created embryo can only develop inside the womb of a woman in the same way that all embryos and fetuses develop. Cloned children will be full-fledged human beings, indistinguishable in biological terms from all other members of the species. Thus, the notion of a soulless clone has no basis in reality.", in Remaking Eden: Cloning and Beyond in a Brave New World (Avon Books 1997), p. 107.

"This experiment [producing Dolly] demonstrated that, when appropriately manipulated and placed in the correct environment, the genetic material of somatic cells can regain its full potential to direct embryonic, fetal, and subsequent development." - National Institutes of Health, Background Paper: Cloning: Present uses and Promises, Jan. 29, 1998, p. 3.

"The Commission began its discussions fully recognizing that any effort in humans to transfer a somatic cell nucleus into an enucleated egg involves the creation of an embryo, with the apparent potential to be implanted in utero and developed to term." - Cloning Human Beings: Report and Recommendations of the National Bioethics Advisory Commission (Rockville, MD: June 1997), p. 3.

[Expressing disbelief that some deny that human cloning produces an embryo]: "If it's not an embryo, what is it?" - Jonathan Van Blerkom, human embryologist at University of Colorado, in American Medical News, Feb. 23, 1998, p. 32 (Dr. Van Blerkom said researchers' efforts to avoid the word "embryo" in this context are "self-serving.") [Back]

14 For example, in the recent abortion bill attempted in South Dakota, the formal definition of "unborn human beings" used would imply that all "unborn human beings" are only reproduced sexually: "(2) 'Unborn human being,' an individual living member of the species homo sapiens throughout the entire embryonic and fetal ages of the unborn child from fertilization to full gestation and childbirth'". The formal definition of "pregnancy" used is: "the human female reproductive condition, of having a living unborn human being within her body throughout the entire embryonic and fetal ages of the unborn child from fertilization to full gestation and child birth." This definition would not apply to sexually reproduced "unborn human beings" of women who are undergoing IVF before implantation; nor would it apply to any asexually reproduced "unborn human beings" before or after implantation - (South Dakota Bill 1191 as Enrolled, 02/25/2004, Vetoed for style and form H.J. 849), http://legis.state.sd.us/mylrc/index.cfm?FuseAction=MainMenu&CFID=3624581&CFTOKEN=82690369. [Back]

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