What Human Embryo?
Funniest Mental Gymnastics from Medicine and Research

22  Twinning can take place after 14-days, which fact itself negates any scientific legitimacy of a "pre-embryo": "[O]ther events are possible after this time [segmentation -- 14 days] which indicate that the notion of "irreversible individuality" may need some review if it is to be considered as an important criterion in human life coming "to be the individual human being it is ever thereafter to be". There are two conditions which raise questions about the adequacy of this notion: conjoined twins, sometimes known as Siamese twins, and fetus-in-fetu. ... Although conjoined twins and fetus-in-fetu have rarely been documented, the possibility of their occurring raises several points related to the notion of irreversible individuality. Conjoined twins arise from the twinning process occurring after the primitive streak has begun to form, that is, beyond 14 days after fertilization, or, in terms of the argument from segmentation, beyond the time at which irreversible individuality is said to exist. ... Similar reasoning leads to the same confusion in the case of fetus-in-fetu. ... One case recorded and studied in detail showed that the engulfed twin had developed to the equivalent of four months gestation and consisted of brain, bones, nerve tissue, muscle and some rudimentary organs. Microscopic study showed that engulfment had occurred at about four weeks after fertilization, in terms of the argument for segmentation long after the time when it is claimed that individuality is resolved." [Her reference is: Yasuda, Y., Mitomori, T., Matsurra, A. and Tanimura, T., "Fetus-in-fetu: report of a case", Teratology 31 (1985), 337-41.] [Karen Dawson, "Segmentation and moral status", in Peter Singer, Helga Kuhse, Stephen Buckle, Karen Dawson, and Pascal Kasimba, Embryo Experimentation (New York: Cambridge University Press, 1990), pp. 57-59].

See also Moore and Persaud, 1998: "Late division of early embryonic cells, such as division of the embryonic disc during the second week, results in MZ twins that are in one amniotic sac and one chorionic sac." (p. 159); " ... If the embryonic disk does not divide completely, or adjacent embryonic discs fuse, various types of conjoined MZ twins may form. ... the incidence of conjoined (Siamese) twins is 1 in 50,000- 100,000 births." (p. 161) "... Partial duplication at an early stage and attempted duplication from 2 weeks onward (when bilateral symmetry has become manifest) would result in conjoined twins." (p. 30); O'Rahilly and Muller, 1994: "Once the primitive streak has appeared at about 13 days, splitting that involves the longitudinal axis of the embryo would be incomplete and would result in conjoined twins." (p. 30); O'Rahilly and Muller, 2001: "Similarly, after the appearance of the primitive streak and notochordal process, any attempt at longitudinal division would be incomplete and would result in conjoined [Siamese] twins. " (p. 55) [Back]

23 See such arguments for "immediate personhood" in my doctoral dissertation, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (Doctoral dissertation, Georgetown University, Washington, D.C., 1991). See same analysis summarized in Irving article, "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. [Back]

24 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]

25 See discussion and references for many of these definitions of "person" in Irving, "The impact of international bioethics on the 'sanctity of life ethic', and the ability of Catholic ObGyn's to practice according to conscience"; presented at the international conference, The Future of Obstetrics and Gynaecology: The Fundamental Human Right to Practice and Be Trained According to Conscience; sponsored by the International Federation of Catholic Medical Associations(FIAMC), and MaterCare International, Rome, Italy, June 18, 2001, Proceedings of the Conference (in press); also in, Journal: Canadian Chapter, Fellowship of Catholic Scholars (Autumn 2002), pp. 7-32, at: http://perso.club-internet.fr/frblin/fiamc/03events/0110gyneco/gyntexts/irving.htm; http://www.matercare.org/Rome/Part1Irving.html; and http://www.lifeissues.net/writers/irv/irv_40bioandconscience01.html. [Back]

26 See Irving, op.cit. [Back]

27 See, e.g., "Stem Cell Research and the Human Embryo, Part One" by Edward J. Furton, M.A., Ph.D. and Micheline M. Mathews-Roth, M.D. which appeared in the August, 1999 issue of Ethics & Medics., at: http://www.ethicsandmedics.com/specials/9908-1.html.; see Irving response at: http://www.lifeissues.net/writers/irv/irv_71recordstraight1.html. [Back]

28 Congressional testimony of Michael D. West, Ph.D., President && CEO, Advanced Cell Technology, Inc. (July 18, 2001), at: http://www.advancedcell.com/testimony-2001-07-18.htm. [Back]

29 Irving Weissman, M.D., "A Message from the Director of the Institute of Cancer/Stem Cell Biology and Medicine at Stanford", in The Stanford Report (Jan. 22, 2003): http://newsservice.stanford.edu/news/2003/january22/message.html. Weissman, along with cloning researchers Ron MacKay and Ann McLaren, recently presented their work to the Pontifical Academy of Sciences, see http://www.vatican.va/roman_curia/pontifical_academies/acdscien/400_ann/program.htm. [Back]

30 Carlson (1999): This process, which occurs about 4 days after fertilization, is called cavitation, and the fluid-filled space is known as the blastocoele. At this stage, the embryo as a whole is known as a blastocyst. (p. 38) ... At the blastocyst stage, the embryo consists of two types of cells: an outer superficial layer (the trophoblast) that surrounds a small inner group of cells called the inner cell mass. O'Rahilly and Muller (1994): During the first week the embryo becomes a solid mass of cells and then acquires a cavity, at which time it is known as a blastocyst. (p. 23); O'Rahilly and Muller (1994): Thus the germ layers should not be considered in rigid isolation one from another, and many interdependences, particularly what are termed epithelio-mesenchymal interactions, are important in development. (p. 10); ... The developmental adnexa, commonly but inaccurately referred to as the "fetal membranes", include the trophoblast, amnion, chorion, umbilical vesicle (yolk sac), allantoic diverticulum, placenta and umbilical cord. These temporary structures are interposed between the embryo/fetus and the maternal tissues. ... The adnexa are programmed to mature fast, to age more rapidly, and to die sooner than the embryonic/fetal body. Nevertheless they are genetically a part of the individual and are composed of the same germ layers. (p. 51). [Back]

31 Report of the California Advisory Committee on Human Cloning (Jan. 11, 2002), Sacramento, CA, at: http://scbe.stanford.edu/conference/cloning_cali.pdf. [Back]

32 Irving Weissman, M.D., "A Message from the Director of the Institute of Cancer/Stem Cell Biology and Medicine at Stanford", in The Stanford Report (Jan. 22, 2003): http://newsservice.stanford.edu/news/2003/january22/message.html. [Back]

33 California's cloning law (SB 1230) can be found at: http://info.sen.ca.gov/pub/01-02/bill/sen/sb_1201-1250/sb_1230_bill_20020923_chaptered.html; their "stem cell research" law (SB 253) is at: http://info.sen.ca.gov/pub/01-02/bill/sen/sb_0251-0300/sb_253_bill_20020922_chaptered.html. [Back]

34 See California Stem Cell Research and Cures Initiative, at: http://www.curesforcalifornia.com/. [Back]

35 See NIH link at: http://www.curesforcalifornia.com/stemcells.php. [Back]

36 See Dr. Varmus' 1999 testimony on the NIH website at: http://stemcells.nih.gov/fedPolicy/statement.asp. See also, 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: http://www.lifeissues.net/writers/irv/irv_39anlystemcel1.html, and at http://www.uffl.org/irving/irvnih.htm. [Back]

37 National Academy of Sciences, Stem Cells and the Future of Regenerative Medicine (2002), Commission on Life Sciences, "Comparison of Stem Cell Production with Reproductive Cloning", at: http://books.nap.edu/books/0309076307/html/11.html#pagetop. [Back]

38 National Academy of Sciences, Scientific and Medical Aspects of Human Reproductive Cloning (2002) Committee on Science, Engineering, and Public Policy, p. 33, at: http://books.nap.edu/books/0309076374/html/25.html. [Back]

39 Steven Ertelt, "Doctors Group Assails Stem Cell Research Backer's Cloning Statement", (October 1, 2004), at: http://www.lifenews.com/bio481.html. [Back]

40 Ibid. [Back]

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

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

43 O'Rahilly and Muller (2001), p. 31. [Back]

44 O'Rahilly and Muller (2001), p. 88. [Back]

45 See cloning by "twinning" (embryo splitting, embryo multiplication) used as a form of "infertility treatment" in major IVF clinics, note 3 supra. [Back]

46 Tesarik J, Martinez F, Rienzi L, Ubaldi F, Iacobelli M, Mendoza C, Greco E. (Spain), "Microfilament disruption is required for enucleation and nuclear transfer in germinal vesicle but not metaphase II human oocytes", Fertil Steril. 2003 Mar;79 Suppl 1:677-81, [PMID: 12620476], at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12620476. [Back]

47 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 http://www.geometry.net/detail/basic_i/infertility_family_science_page_no_3.html. [Back]

48 H.R.2673, FY 2004 Consolidated Appropriations Bill, 1/23/2004 Became Public Law No: 108-199, United States Patent and Trademark Office [http://thomas.loc.gov/cgi-bin/query/D?c108:6:./temp/~c108830u57:e308591:] [Back]

49 BIO (Biotechnology Industry Organization, "Cloning Patent Fact Sheet: New Patent Legislation Sets Dangerous Precedent and Stifles Research" (Sept. 2, 2003), at: http://www.bio.org/ip/action/cloningfactsheet.asp. See also, Jim Abrams, "Lawmakers weigh human organism patent ban", Seattle Post-Intelligencer, at: http://www.gene.ch/genet/2003/Nov/msg00082.html. [Back]

50 PARTNERS Health Care, "Memorandum" to Investigators involved with or planning to be involved with hESC research (June 23, 2004), at: http://healthcare.partners.org/phsirb/investigatorletter_june23.pdf. [Back]

51 Anne Harding, "Harvard has human cloning plans", The Scientist, October 15, 2004, at: http://www.biomedcentral.com/news/20041015/03 [Back]

52  IRB's were "born" with the "birth" of bioethics. The 1974 National Research Act (Kennedy and McGovern) that gave "birth" to bioethics also mandated that the "ethical principles" identified by the National Commission be transformed into federal guidelines for the use of human subjects in research. Thus in 1981 the OPRR (now, OHRP) federal regulations were established, requiring that the use of federal funds in research be monitored by "institutional review boards" (IRB's), and they were to follow the "IRB Guidebooks" issued by DHHS. [It is this same OPRR that scientifically mis-defines both "pregnancy" and "fetus" as beginning at implantation!).

Since that time the malfunctioning of and abuses of these IRB's have grown to epidemic proportions, resulting in numerous private, governmental and Congressional oversight hearings on these abuses. For example, in 1997 the National Bioethics Advisory Commission's Human Subjects Subcommittee held hearings. Also in 1997 Rep. Christopher Shays chaired a series of hearings, "Oversight of HHS (Department of Health and Human Services): Bioethics and the Adequacy of Informed Consent," conducted by the House Government Reform and Oversight Committee's Human Resources subcommittee. Senators Frist and Kennedy held similar hearings in 2002, i.e., the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, "Protecting Human Subjects in Research: Are Current Safeguards Adequate?"

The literature on IRB's is enormous, but the following selection might help those unfamiliar with it at least get into the "ballpark". See, e.g., various testimonies by Alliance for Human Research Protection: Sharav, "Testimony before the National Bioethics Advisory Commission, Human Subjects Subcommittee", Sept. 18, 1997, http://www.ahrp.org/testimonypresentations/NBAC1997/sharav.html; Sharav, "Chemically Induced Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research", Submitted To U.S. Senate Sub-Committee: Public Health & Safety of the Senate Health, Education, Labor & Pensions Committee Hearing Feb. 2, 2000, http://www.ahrp.org/testimonypresentations/InducedPsychosis.html; Sharav and Cassidy, "Testimony Submitted to the Office of Human Research Protection (OHRP)", April, 2001, http://www.ahrp.org/testimonypresentations/sharavCassidyOHRP.html; Sharav and Noble, "Testimony before the Subcommittee on Public Health, Committee on Health, Education, Labor, & Pensions, United States Senate at Hearing", "Protecting Human Subjects in Research: Are Current Safeguards Adequate?" on April 23, 2002, http://www.ahrp.org/testimonypresentations/childrenApril02.html; Sharav, "Human Experiments: A Chronology of Human Research".

See also Sue McGreevey, "Almost half of all faculty on Institutional Review Boards have ties to industry", study by Harvard and Partners, Aug. 14, 2003, http://www.boston.com/dailyglobe2/084/nation/System_for_protecting_humans_in _research_faulted+.shtml; Michael Kranish, "System for protecting humans in research faulted", Boston Globe, Mar. 25, 2002, http://www.boston.com/dailyglobe2/084/nation/System_for_protecting_humans_in _research_faulted+.shtml; Dr. Angela J. Bowen, Institute for Health Freedom, "Testimony before "Institutional Review Boards: A System in Jeopardy?"", June 11, 1998, http://forhealthfreedom.org/Publications/Children/hr61198/bowen.html; Sidney M. Wolfe and Peter Lurie "Comments before 'Institutional Review Boards: A System in Jeopardy'", June 11, 1998, http://www.comite.bioetica.org/biblio8.htm; "IRBs Come Under Scrutiny of Congressional Subcommittee", Psychiatric News, http://www.psych.org/pnews/98-08-07/irb.html; National Patient Safety Foundation, "Accountability in Clinical Research: Balancing Risk & Benefit Forum Report", April 24-26, 2002 http://www.researchsafety.org/download/2002ForumReport.pdf; a helpful mini-summary can be found by WashingtonFAX, "Protecting human research subjects", http://www.washingtonfax.com/samples/docs/bioethics/patients/index.html. [Back]

53  The relevant current federal regulations are found in Title 45 Code of Federal Regulations Part 46 Protection of Human Subjects (revised June 18, 1991), 45 CFRpart46, "Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research," Revised November 13, 2001, Effective December 13, 2001 [[Source: Federal Register: November 13, 2001 (Volume 66, Number 219), Rules and Regulations, Page 56775-56780, from the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13no01-9] ]], at: http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html.

The current OHRP federal regulations were originally referred to as the OPRR regulations (Office for the Protection from Research Risks), which were formally created in response to the very same Congressional mandate (the 1974 National Research Act) that gave "birth" to bioethics in 1978 (see the National Commission's Belmont Report). That is, the Belmont Report defined the "ethical principles" that the federal government should use in assessing the use of human subjects in research. Those "ethical principles" became known as "autonomy", "justice", and "beneficence" (which terms were given rather odd and very utilitarian definitions by the National Commission). These same "ethical principles" were then to be used as the basis for new federal regulations on the use of human subjects in research. Thus, in 1981 the original OPRR federal regulations were created, using the "Belmont principles" as the basis for the government to determine which research is "ethical" and which is not. It is these "ethical principles", and the formal definitions used in the federal regulations, that IRB's are required to follow in their determinations.

For an extensive history of the "birth" of bioethics, an evaluation of its principles, with extensive scientific, philosophical and historical references, see Irving, "What is 'bioethics'?", 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 at http://www.uffl.org/irving/irvwhatisbio.htm. For a shorter version, see "The bioethics mess", Crisis Magazine, Vol. 19, No. 5, May 2001, at: http://www.catholic.net/rcc/Periodicals/Crisis/2001-05/irving.html, and at http://www.lifeissues.net/writers/irv/irv_37bioethicsmess.html. [Back]

54 See accurate scientific references in note 2 supra. [Back]

55 Josef Pieper, Abuse of Language - Abuse of Power (San Francisco: Ignatius Press, 1992), pp. 7, 18-20. [Back]

1, 2, 3, 4, 5,