Dianne N. Irving, M.A., Ph.D.
Former bench research biochemist/biologist NIH/NCI; Professor of Philosophy, The Catholic University of America, Washington, D.C.
copyright November 1, 2002
Monday, November 4, 2002
Committee Room #4, New Jersey State House Annex
Trenton, New Jersey
LEGALLY VALID INFORMED CONSENT:
Individual Testimony before the New Jersey State Senate Health and Human Services Committee on Human Embryonic Stem Cell Research, Ethical and Public Policy Considerations **
Also submitted for the official record: Three articles with extensive scientific, bioethical, and philosophical references to substantiate this testimony:
1. D. N. Irving, "When does a human being begin? 'Scientific' myths and scientific facts" (International Journal of Sociology and Social Policy, 1999, 19:3/4:22-47).
2. D. N. 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.
3. D. N. Irving, "Philosophical and scientific expertise: An evaluation of the arguments on 'personhood'" (Linacre Quarterly, Feb. 1993, 60:1:18-46).
[[Note: This invited testimony was presented at the November 4, 2002, meeting of the New Jersey State Senate Committee in Trenton, NJ. Other such hearings were also subsequently held. Just before the final vote on the bill, an amendment was accepted defining “a cloned human embryo” as not existing until after the newborn stage. Legal experts agreed that this scientifically erroneous definition of “a cloned human embryo” would open the door to embryonic and fetal harvesting. (See: http://www.njrtl.org/L021003b.html). Since this amendment was passed after the hearing at which I testified, this erroneous scientific definition of “a human clone” is not included in my testimony below. My analysis, therefore, focuses on a series of other equally serious scientifically erroneous definitions and linguistic loopholes which in and of themselves would also allow both therapeutic and reproductive cloning – regardless of the definition of “a human clone” slipped into the bill at the last minute. – DNI]]
Mr. Chairman and Members of this Senate Committee:
I am honored and very appreciative to be able to speak before the committee today on these important and controversial issues, and I thank the committee for giving me time to present some relevant information which I offer to you for your consideration.
Accurate and credible information about the ethics and public policy ramifications of the use of living human embryos -- whether produced sexually or a-sexually -- for deriving stem cells for important biomedical research and "therapies" for curing devastating diseases is critically important. One consideration that is often neglected in these discussions and debates is that such information is vital for the ethically and legally valid "informed consent" of the donors and the recipients involved, the legislators, and the citizen voters of the State of New Jersey as well.
Obviously, "informed consent" requires that full, accurate and truthful information be disseminated to all concerned decision makers. But valid "informed consent" must also include disseminating the correct and accurate scientific information about "what" these early human embryos are -- even before discussing the ethical and public policy issues surrounding their use as sources of stem cells. Are they prawns, cabbages, fish, frogs, chickens, monkeys, or human beings? Are they just "eggs" such as those used in fertilization, skin cells, "bunches of stem cells", "pre-embryos", or merely the earliest stages of "the evolving human species"? The ethical and public policy
decisions themselves should be grounded in the answer to this scientific question -- the necessary and required starting point for all of the other discussions. Otherwise, public policy will continue to be irresponsibly based on mere fantasies and wishful thinking.
One thing I want to make perfectly clear today. What I will testify to is not just one subjective opinion to be considered among many others in a democratic, multicultural, pluralistic society. Rather, it is simply the reporting of irrefutable objective scientific facts -- critically relevant facts which must be used as the basis for all other ethical and public policy making decisions facing this committee. I will use absolutely no subjective "religious", "theological", "political", or "personal" opinions in this testimony. I will simply refer to the objective scientific facts documented by 100% of the experts in the field of human embryology -- the only scientists who are academically credentialed to answer the question, "When do human beings begin to fully exist?" These objective scientific facts are accessible to any one who wishes to locate them in human embryology text books in their local libraries.
It would seem that many people do not know that, unlike some other fields, in the field of human embryology these objective scientific facts are ultimately determined by the international Nomina Embryologica Committee, consisting of over 20 of the best and brightest human embryologist from around the world. After reviewing the latest research studies in human embryology, their deliberations are published in the Nomina Embryologica, part of the larger Nomina Anatomica, and are professionally required to be used, along with The Carnegie Stages of Early Human Development, by all human embryologists in their own work. Several of the human embryologist from whom I quote in my submissions are long-time members of this international Nomina Embryologica Committee. Indeed, one of them, i.e., the eminent Swiss researcher Dr. Ronan O'Rahilly, the "dean of human embryology", was also one of the originators of the famous Carnegie Stages.
Just as the appeals courts are reversing prior lower court decisions because of increased and advanced knowledge in the sciences, e.g., the advent and subsequent use of the new DNA profiling technology (nuclear DNA and/or mitochondrial DNA) in identifying crime suspects, I would respectfully suggest that legislators too consider the use of early human embryos in research and therapy in the light of the most internationally agreed upon, objective, current, and accurate scientific facts of human embryology. Nothing less than this can insure objective, sound, well-grounded, and credible public policies concerning human embryonic stem cell research. Nothing less than this can insure ethically and legally valid "informed consent".
Before proceeding, I want to make an important distinction which is often neglected in these debates. The question of when a human being begins to exist is strictly a scientific question -- and should be answered by the real experts, those academically credentialed in human embryology. The question of when a human person begins to exist is a philosophical -- or political -- decision, and must be able to withstand the rigors of scholarship and intense debates.
I will focus first on the scientific question, and make a further distinction between sexual human reproduction (e.g., the use of sperm and oocytes in the reproductive process of fertilization), and a-sexual human reproduction (e.g., in the several different reproductive processes of cloning). Time only permits me to basically list the most relevant scientific points. Further extensive details and references can be found in the additional scientific materials I am submitting to this committee for the record.
SEXUAL HUMAN REPRODUCTION
Speaking of scientifically grounded legally valid "informed consent":
1. Did you know that it has been known for over a hundred years that the immediate product of human fertilization is an embryo, an individual, a single-cell organism, a zygote, a new unique fully existing living human being -- and that fertilization is the beginning of the embryonic period, and of normal pregnancy? And that early spontaneous abortions, or "pregnancy wastage" really occurs because of a seriously abnormal embryo, or an improperly prepared uterus?
2. Did you know that immediately at fertilization human species-specific proteins and enzymes are produced, and later human species-specific tissues and organs are produced? Indeed, this simple fact is the scientific basis for using human embryos in human experimental and therapeutic research.
3. Did you know that the whole 5-7 day old human blastocyst is the embryo, not just the cells of the inner cell mass -- and that cells of the inner cell mass are totipotent (not pluripotent)?
4. Did you know that twinning can take place after 14-days?
5. Did you know that there is no such thing as a "fertilized egg"; no such thing as an "ovum"?
6. Did you know that there is no such thing as a "pre-embryo"? The term is a complete scientific myth. Indeed, the always dubious and arbitrary term "pre-embryo" has recently been formally rejected as scientifically ill-defined, inaccurate, unjustified, equivocal, and politically motivated by the international Nomina Embryologica Committee, along with the related and equally scientifically rejected term "individualization".
7. Did you know that there is also no such thing as a human embryo or fetus who is an evolving "human-being-on-the-way"? This is also a complete scientific myth, and based on the old "biogenetics law" (or "ontogeny recapitulates phylogeny") -- rejected by the scientific community many decades ago.
Scientifically, then -- according to 100% of the expert specialists in the field of human embryology worldwide -- there is no question or confusion whatsoever that the immediate product, and all continuous, contiguous, growth and developmental stages thereafter through adulthood, involves an already fully existing unique living human being.
A-SEXUAL HUMAN REPRODUCTION
Human beings can also be reproduced a-sexually, without the use of sperm or oocytes -- as we know empirically happens in human monozygotic twinning (a common, and the most exact form of, cloning). Just as the single-cell organism produced sexually at fertilization is a human being, the single-cell organism produced a-sexually at cloning is also a human being. There are two biological processes that can help people understand this objective scientific fact: methylation, and regulation:
1. Methylation: Briefly, following sexual reproduction the early human embryo grows and develops by means of methylating and demethylating the DNA in each of the embryo's or fetus's cells. That is, the DNA in each cell is "allowed to speak", or is "silenced", by adding or removing these methylation bars -- depending on what products the embryo needs to grow and develop. These products then "cascade" down throughout growth and development. The more specialized, or differentiated, a cell, the more methylated its DNA becomes. I will refer to this process during growth and development following sexual human reproduction as a sort of "zipping up". By adulthood, the DNA in many of the cells of the human being has been almost completely "silenced" by the insertion of methylation bars -- such as in human skin cells.
By contrast, during human a-sexual reproduction (such as in twinning, or in somatic cell nuclear transfer) much of this methylation process is reversed, and the methylation bars are gradually almost all removed, resulting in the production of a new living human organism -- a single-cell human being, a zygote. I will refer to this process during a-sexual human reproduction as "zipping down". This at least partially explains how an adult cell can be transformed into a whole new single-cell organism.
2. Regulation: Regulation is operative in both "zipping up" and "zipping down". In "zipping up", as in sexual reproduction (fertilization), regulation concerns various processes of differentiation; but it also becomes involved when an injury has occurred to the organism. Here, regulation is the ability of an embryo or an organ primordium to "heal" a normal structure if parts have been removed or added. In "zipping down", as in a-sexual reproduction such as twinning, regulation could possibly revert separated totipotent embryonic cells back to new living human embryos, i.e., new living human beings. Indeed, this is precisely what happens with human monozygotic twinning in vivo, and in somatic cell nuclear transfer.
Finally, there are many different kinds of human cloning techniques possible, including twinning (blastomere separation and blastocyst splitting), somatic cell nuclear transfer (SCNT), germ line cell nuclear transfer (GLCNT), etc. In all such cloning techniques, the immediate product would be a new living human being.
Note, however, for legislative purposes: in somatic cell nuclear transfer or in germ line cell nuclear transfer, the human being produced would not be "an exact genetic copy of the donor cell" -- because the mitochondrial DNA of the donor cell is not transferred, and the mitochondrial DNA of the recipient oocyte cell is retained in the newly produced human being. Thus to scientifically misdefine the product of SCNT or GCNT in legislation would be to preclude that legislation from actually applying to these real cloning techniques. And many have grave concerns about the use of germ line cells in sexual or a-sexual human reproduction for eugenic purposes.
These objective scientific facts about sexual and a-sexual human reproduction must be the starting point for any legislation on the use and destruction of these early innocent living human beings in stem cell research or cloning, and part and parcel of any ethically and legally valid process of "informed consent."
To claim that these innocent and vulnerable living human beings can be used and destroyed in order to help other human beings -- especially when there are viable alternatives, such as the use of umbilical cord and adult stem cells -- is to legislatively create a subcategory of human beings who may be exploited as a mere commodity for the use of other human beings -- and we've been there before. The argument is that some human beings are not "persons", and other human beings are "persons", and is based on a theory about active "functionality", rather than on the empirical facts about a thing's nature.
Such is the position of many of those in bioethics, e.g., Peter Singer, Director of Human Values at Princeton University (Princeton, New Jersey). Singer opines that "personhood" is defined only by the active exercising of "rational attributes" (e.g., willing, choosing, knowing, relating to the world around one, etc.) or "sentience" (e.g., the feeling of pain and pleasure) -- a philosophical claim inherently based on passé 17th and 18th century Cartesian, rationalist, and empiricist philosophical systems. Time does not permit a further philosophical analysis (and I refer you to extensive philosophical refutations of these theories in my submitted materials), but suffice it to say here that these philosophical systems are fraught with inherent contradictions, are academically and realistically indefensible, and were literally laughed out of the academy by the late 1800's. They were recently revived, however, by contemporary bioethics. One reason for their indefensibility is simply that if there are two separate and different things, such as a "mind" or "soul" thing, and a "body" thing, there is no possible way to explain any interaction between these two different and separated things. In philosophical parlance, this is known as the myth of the "mind/body" split -- or chorismos.
Further, virtually all of the contemporary bioethics arguments for "delayed personhood" are based on and grounded in very erroneous "science" -- hence their philosophical "personhood" conclusions are automatically invalid.
Finally, "pushing the logic" of those bioethics definitions of "person" leads to extraordinarily bizarre conclusions -- and it would be wise, I respectfully suggest, not to cement them into legislation. Peter Singer, for example, opines that some human beings are not "persons", and some animals are "persons". Indeed, this is the basis for Singer's recent defense of "bestiality". But think about it: if only those who are actively exercising "rational attributes" and "sentience" are "persons", then the following list of adult human beings are not "persons", and thus not ethically or legally protected as real "persons": Alzheimer's and Parkinson's patients, the mentally ill and mentally retarded, the frail elderly, the emotionally ill, drug addicts and alcoholics, literally all mentally and physically disabled, -- even all of us when we are sleeping! Richard Frey, a senior bioethics scholar at the Hastings Center, agrees -- arguing that the adult human beings I have just listed be substituted for animal "persons" in destructive experimental research! Abstract concepts can lead to concrete, and devastating, consequences in the real world.
"Personhood", then, must be based on the kind of nature a thing possess, not on its active "functionality" -- unless you would agree with the conclusions that necessarily follow from the theories of the likes of Singer, Frey, and most bioethicists. The human being and the human person are inseparable -- from the very beginning of his or her existence.
So we need to consider where we are going with this legislation. It is worth noting briefing that such bioethics concepts of "personhood" can, and already have been, transferred from these debates on human embryo research to adult human beings in most bioethics debates on euthanasia, physician-assisted suicide, organ transplantation, removal of food and water, the use of human subjects in research, etc. Is this the kind of society the good citizens of New Jersey want? Do they fully know and fully understand the massive theoretical defects of this bioethics "personhood" information, and the bizarre and devastating conclusions that must necessarily follow from it? I don't think so.
There is one further bit of "ethical" information that I suggest most people are also basically uninformed about -- the dubious validity of bioethics as the basis for any legislative decision making. Bioethics was formally "born" in the 1978 Belmont Report of the National Commission -- mandated by the U.S. Congress in its 1974 National Research Act. This commission identified and (oddly) defined the three bioethical principles of "autonomy", "justice", and "beneficence", referred to as "principlism", or "the Georgetown mantra". But bioethics is not "ethics-per-se"; it is only one of a dozen different ethical theories developed through the centuries -- and a very recent one at that. Nor is bioethics "neutral"; it defines itself as "normative" -- i.e., it takes a stand on what is right or wrong. Thus how can any one justify forcing that normative ethical theory on the rest of us through legislation in this democratic, multicultural, pluralistic society?
Furthermore, bioethics is fraught with so many theoretical and practical problems that even many of the Founders of bioethics themselves have admitted that it can't and doesn't work. The bioethics literature is full of hot and turbulent on-going debates on whether or not bioethics is a valid ethical theory at all. And as one of the original scholars of the Hastings Center wisely expressed when observing the creation of bioethics by the National Commission, "What one fears", he said, "is that the [National] Commission may become the mechanism whereby the speculations of the ethicists become the law of the land. It is already far too easy for abstract notions of right and wrong to emerge as deontological rules which begin their public life as 'guidelines' but culminate in the force of law." Thus "informed consent" also requires that decision makers on all levels understand at least that to base any "ethical" decisions on bioethics theory or bioethics definitions of terms is dubious at best, and basically indefensible.
I have indicated that "personhood" arguments often appealed to in these debates are essentially a political gambit which cannot be academically, theoretically, or practically defended, and that to use current non-neutral normative bioethics theories and definitions in legislation is likewise indefensible in this democratic, multicultural, pluralistic society. I have attempted to briefly present the well-established objective scientific facts which establish beyond any shadow of a doubt that the immediate products of both sexual and a-sexual human reproduction are innocent living human beings. Responsible and credible legislation concerning human stem cell research, as well as valid "informed consent", must be grounded first and foremost in these objective scientific facts.
We do know scientifically "what" these early human embryos are -- they are innocent living human beings -- and we have known this for over a century. To try to legislate false and erroneous science is a dangerous enterprise, unbecoming of this great legislature. And to attempt to claim that these human beings are "less than" other human beings is to legislate a sub-category of human beings as mere commodities. It is also to legislate the basis for future "conceptual transfer" -- i.e., the transfer of indefensible and irresponsible bioethics definitions of "personhood" to even adult human beings -- most of them very vulnerable. Is this what the good citizens of New Jersey would want -- if they knew and fully understood the whole truth?
For the above reasons, and many others stated elsewhere in my submitted work, I would conclude that it is unethical and irresponsible to use and destroy, or to pass legislation permitting the use and destruction of, living human embryos -- produced sexually or a-sexually -- in destructive biomedical research and/or "therapy". The end, even a worthy one, does not justify the use of any and all means. Ethical, and safer, alternative means are now available.
Thank you, again, for the opportunity to provide testimony concerning human embryonic stem cell research, and its ethical and public policy implications before the New Jersey Senate Health and Human Services Committee.
Dr. Dianne N. Irving, M.A., Ph.D.
 Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 2001), p. ix.
 See, e.g., Dianne N. Irving, "When does a human being begin? 'Scientific' myths and scientific facts" (International Journal of Sociology and Social Policy, 1999, 19:3/4:22-47). [Copy submitted to this Committee for the official record]
 Wilhelm His, Anatomie menschlicher Embryonen (Leipzig: Vogel, 1880-1885); O"Rahilly and Muller 1994, p. 3; Keith L. Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (use 6th ed. only) (Philadelphia: W.B. Saunders Company, 1998), p. 12.
 [emphases added]: "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... [The] coalescence of homologous chromosomes results in a one-cell embryo. ...The zygote is ... a unicellular embryo and is a highly specialized cell. ... [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)." [O'Rahilly and Muller, 2001, p. 87]
"Human pregnancy begins with the fusion of an egg and a sperm, ... Finally, the fertilized egg, now properly called an embryo, must make its way into the uterus ....". [Bruce Carlson, Human Embryology and Developmental Biology (St. Louis, MO: Mosby, 1994); also, Carlson, ibid., (2nd ed., 1999, p. 2]
"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]... Embryonic development is considered to begin at this point. ... 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." [William Larson, Human Embryology (2nd ed.) (New York: Churchill Livingstone, 1997), pp. 1, 17]
"A zygote is the beginning of a new human being (i.e., an embryo); [Z]ygote: This highly specialized, totipotent cell marks the beginning of each of us as a unique individual.... Although fertilization may occur in other parts of the tube, it does not occur in the uterus. ... [T]he zygote, a unicellular embryo... " [Moore and Persaud 1998, pp. 2, 34]
 [emphases added]: "A high percentage of abortuses (30-80%, depending on the study) are structurally abnormal, and it is maintained that all abortuses under 4 postovulatory weeks have abnormally formed embryonic tissue. Thus, spontaneous abortion greatly reduces the number of malformed fetuses born." [O'Rahilly and Muller 2001, pp. 92-93]
"Early spontaneous abortions occur for a variety of reasons, one being the presence of chromosomal abnormalities in the zygote. The early loss of embryos, once called pregnancy wastage, appears to represent a disposal of abnormal conceptuses that could not have developed normally, i.e., there is a natural screening of embryos." [Moore and Persaud 1998, p.p. 42 - 43]
 See, e.g., G. Kollias, J. Hurst, E. deBoer, and F. Grosveld, "The Human beta-globulin gene contains a downstream developmental specific enhancer", Nucleic Acids Research 15(14) (July 1987), 5739-47; R. K. Humphries et al, "Transfer of human and murine globin-gene sequences into transgenic mice", American Journal of Human Genetics 37(2) (1985), 295-310; A. Schnieke et al, "Introduction of the human pro alpha 1 (I) collagen gene into pro alpha 1 (I) - deficient Mov-13 mouse cells leads to formation of functional mouse-human hybrid type I collagen", Proceedings of the National Academy of Science - USA 84(3) (Feb. 1987), pp. 764-8.
 [emphases added]: "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. The appearance of these two cell types reflects major organizational changes that have occurred within the embryo and represents the specialization of the blastomeres into two distinct cell lineages. Cells of the inner cell mass give rise to the body of the embryo itself plus a number of extraembryonic structures." (Carlson 1999, pp. 39-40)
"'Primordium'" [e.g., "embryo proper"]: This term refers to the beginning or first discernible indication for the earliest stage of development of an organ or structure." (Moore and Persaud 1998, p. 3)
"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." (O'Rahilly and Muller 1994, p. 51).
 "The appearance of the blastocyst demonstrates the differentiation into (1) trophoblast (or trophectoderm), the peripherally situated cells and (under the influence of E-cadherin) in first epithelium formed, and (2) embryonic cells proper. The latter, at first few in number, form the inner cell mass (ICM). The trophoblast at the future site of attachment is sometimes termed polar, the remainder being called mural. The cells of the ICM (inner cell mass) are considered to be totipotent initially." (emphases added) [O'Rahilly and Muller 2001, p. 39]
 "[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: "MZ [monozygotic] twinning usually begins in the blastocyst stage, around the end of the first week (before formation of the germ disc starting at 8 days).... Uncommonly, early separation of embryonic blastomeres, (e.g., during the 2 - 8 cell stages) results in MZ twins with two amnions, two chorions, and two placentas that may or may not be fused. (p. 159); ... About 35% of MZ twins result from early separation of the embryonic blastomeres; i.e., during the first 3 days of development. The other 65% of MZ twins originate at the end of the first week of development; i.e., right after the blastocyst has formed [5-7 days]. 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." (emphases added) [Moore and Persaud 1998, 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); ... 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." [O'Rahilly and Muller 1994, p. 30]. ... 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. " (emphases added) [ibid, 2001, p. 55]
 "Egg"; best confined to the hen and to cuisine; use "oocyte". "Ovum"; does not exist in human; use "oocyte", "ootid", "embryo". [O'Rahilly and Muller 2001, p. 12]
 "The term 'pre-embryo' is not used here for the following reasons: (1) it is ill-defined because it is said to end with the appearance of the primitive streak or to include neurulation; (2) it is inaccurate because purely embryonic cells can already be distinguished after a few days, as can also the embryonic (not pre-embryonic!) disc; (3) it is unjustified because the accepted meaning of the word embryo includes all of the first 8 weeks; (4) it is equivocal because it may convey the erroneous idea that a new human organism is formed at only some considerable time after fertilization; and (5) it was introduced in 1986 'largely for public policy reasons' (Biggers)." ... Just as postnatal age begins at birth, prenatal age begins at fertilization." [O'Rahilly and Muller 2001, p. 88] ... "Undesirable terms in Human Embryology": "Pre-embryo"; ill-defined and inaccurate; use "embryo". (emphases added) [O'Rahilly and Muller 2001, p. 12].
 "Recapitulation, the So-Called Biogenetic Law. The theory that successive stages of individual development (ontogeny) correspond with ("recapitulate") successive adult ancestors in the line of evolutionary descent (phylogeny) became popular in the nineteenth century as the so-called biogenetic law. This theory of recapitulation, however, has had a "regrettable influence on the progress of embryology" (G. de Beer). ... According to the "laws" of von Baer, general characters (e.g., brain, notochord) appear in development earlier than special characters (e.g., limbs, hair). Furthermore, during its development an animal departs more and more from the form of other animals. Indeed, the early stages in the development of an animal are not like the adult stages of other forms but resemble only the early stages of those animals. The pharyngeal clefts of vertebrate embryos, for example, are neither gills nor slits. Although a fish elaborates this region into gill slits, in reptiles, birds, and mammals it is converted into such structures as the tonsils and the thymus." (emphases added) [O'Rahilly and Muller 2001, p. 16].
 "The embryo enters the uterine cavity after about half a week ... Each cell (blastomere) is considered to be still totipotent (capable, on isolation, of forming a complete embryo), and separation of these early cells is believed to account for one-third of cases of monozygotic twinning." (emphases added) [O'Rahilly and Muller, p. 37] " ... Some types of twinning represent a natural experiment that demonstrates the highly regulative nature of early human embryos, ..." (p. 48); "... Monozygotic twins and some triplets, on the other hand, are the product of one fertilized egg. They arise by the subdivision and splitting of a single embryo. Although monozygotic twins could ... arise by the splitting of a two-cell embryo, it is commonly accepted that most arise by the subdivision of the inner cell mass in a blastocyst. Because the majority of monozygotic twins are perfectly normal, the early human embryo can obviously be subdivided and each component regulated to form a normal embryo." (p. 49) (emphases added) [Carlson 1999] "If the splitting occurred during cleavage -- for example, if the two blastomeres produced by the first cleavage division become separated -- the monozygotic twin blastomeres will implant separately, like dizygotic twin blastomeres, and will not share fetal membranes. Alternatively, if the twins are formed by splitting of the inner cell mass within the blastocyst, they will occupy the same chorion but will be enclosed by separate amnions and will use separate placentae, each placenta developing around the connecting stalk of its respective embryo. Finally, if the twins are formed by splitting of a bilaminar germ disc, they will occupy the same amnion." (p. 325) [Larsen 1998] "MZ [monozygotic] twinning usually begins in the blastocyst stage, around the end of the first week (before formation of the germ disc starting at 8 days).... Uncommonly, early separation of embryonic blastomeres, (e.g., during the 2 - 8 cell stages) results in MZ twins with two amnions, two chorions, and two placentas that may or may not be fused. (p. 159); ... About 35% of MZ twins result from early separation of the embryonic blastomeres; i.e., during the first 3 days of development. The other 65% of MZ twins originate at the end of the first week of development; i.e., right after the blastocyst has formed [5-7 days]. [Moore and Persaud 1998, p. 161].
 "The term 'clones' indicates genetic identity and so can describe genetically identical molecules (DNA clones), genetically identical cells or genetically identical organisms. Animal clones occur naturally as a result of sexual reproduction. For example, genetically identical twins are clones who happened to have received exactly the same set of genetic instructions from two donor individuals, a mother and a father. 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." (emphases added) [Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (New York: John Wiley & Sons, Inc, 1999), pp. 508-509].
 "Cells differentiate by the switching off of large portions of their genome." [O'Rahilly and Mueller 2001, p. 39]. "Gene expression is associated with demethylation. Methylation of DNA is one of the parameters that controls transcription. This is one of several regulatory events that influence the activity of a promoter; like the other regulatory events, typically this will apply to both copies of the gene." [Benjamin Lewin, Genes VII (New York: Oxford University Press, Inc., 2000), p. 678; also p. 603]. "Gene regulation as the primary function for DNA methylation: DNA methylation in vertebrates has been viewed as a mechanism for silencing transcription and may constitute a default position." [Strachan and Read, pp. 193 ff]
 "The expression of genes is determined by a regulatory network that probably takes the form of a cascade. Expression of the first set of genes at the start of embryonic development leads to expression of the genes involved in the next stage of development, which in turn leads to a further stage, and so on until all the tissues of the adult are functioning." [Lewin, p. 63; also pp. 914, 950].
 "A variety of early experiments in mice were also unsuccessful before the landmark study of 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. ... Other more recent studies are now forcing us to reconsider the potency of other cells. ... [A]nd so the developmental potential of stem cells is not restricted to the differentiated elements of the tissue in which they reside (Bjornson et al, 1999)." (emphases added) [Tom Strachan & Andrew P. Read, Human Molecular Genetics 2 (New York: Wiley-Liss, 1999), p. 509]
 "Early mammalian embryogenesis is considered to be a highly regulative process. Regulation is the ability of an embryo or an organ primordium to produce a normal structure if parts have been removed or added. At the cellular level, it means that the fates of cells in a regulative system are not irretrievably fixed and that the cells can still respond to environmental cues." (pp. 44-49). ... Blastomere removal and addition experiments have convincingly demonstrated the regulative nature (i.e., the strong tendency for the system to be restored to wholeness) of early mammalian embryos. Such knowledge is important in understanding the reason exposure of early human embryos to unfavorable environmental influences typically results in either death or a normal embryo." (p. 46) [Carlson 1999]
 See note 13, supra; also, (emphases added): "Another means of demonstrating the regulative properties of early mammalian embryos is to dissociate mouse embryos into separate blastomeres and then to combine the blastomeres of two or three embryos. The combined blastomeres soon aggregate and reorganize to become a single large embryo, which then goes on to become a normal-appearing tetraparental or hexaparental mouse. By various techniques of making chimeric embryos, it is even possible to combine blastomeres to produce interspecies chimeras (e.g., a sheep-goat)." (p. 45); "... The relationship between the position of the blastomeres and their ultimate developmental fate was incorporated into the inside-outside hypothesis. The outer blastomeres ultimately differentiate into the trophoblast, whereas the inner blastomeres form the inner cell mass, from which the body of the embryo arises. Although this hypothesis has been supported by a variety of experiments, the mechanisms by which the blastomeres recognize their positions and then differentiate accordingly have remained elusive and are still little understood. If marked blastomeres from disaggregated embryos are placed on the outside of another early embryo, they typically contribute to the formation of the trophoblast. Conversely, if the same marked cells are introduced into the interior of the host embryo, they participate in formation of the inner cell mass. Outer cells in the early mammalian embryo are linked by tight and gap junctions ... Experiments of this type demonstrate that the developmental potential or potency (the types of cells that a precursor cell can form) of many cells is greater than their normal developmental fate (the types of cells that a precursor cell normally forms)." (p. 45); " ... Classic strategies for investigating developmental properties of embryos are (1) removing a part and determining the way the remainder of the embryo compensates for the loss (such experiments are called deletion experiments) and (2) adding a part and determining the way the embryo integrates the added material into its overall body plan (such experiments are called addition experiments). Although some deletion experiments have been done, the strategy of addition experiments has proved to be most fruitful in elucidating mechanisms controlling mammalian embryogenesis." (p. 46). [Carlson 1999] "Of the experimental techniques used to demonstrate regulative properties of early embryos, the simplest is to separate the blastomeres of early cleavage-stage embryos and determine whether each one can give rise to an entire embryo. This method has been used to demonstrate that single blastomeres, from two- and sometimes four-cell embryos can form normal embryos, ... " (emphases added) [Carlson 1999, p. 44]
See also the use of the cloning technique of twinning by "blastomere separation" and "blastocyst splitting" proposed by many IVF researchers -- what they refer to as "embryo multiplication":
Professor Dr. Mithhat Erenus, "Embryo Multiplication": "In such cases, patients may benefit from embryo multiplication, as discussed in the study by Massey and co-workers. ... Since each early embryonic cell is totipotent (i.e., has the ability to develop and produce a normal adult), embryo multiplication is technically possible. Experiments in this area began as early as 1894, when the totipotency of echinoderm embryonic cells was reported ... In humans, removal of less than half of the cells from an embryo have been documented. No adverse effects were reported when an eighth to a quarter of the blastomeres were removed from an embryo on day 3 after insemination. ... Further evidence supporting the viability and growth of partial human embryos is provided by cryopreservation. After thawing four-cell embryos, some cells may not survive, leaving one-, two-, or three-cell embryos. These partial embryos survive and go to term, but at a lower rate than whole embryos. ... Based on the results observed in lower order mammals, the critical period of development to ensure success in separating human blastomeres should be at the time of embryonic gene expression, which is reported in humans to be between the four- and eight-cell stages. .... The second potential method of embryo multiplication is blastocyst splitting. ... Embryo multiplication by nuclear transfer has been used in experimental cattle breeding programs. ... IVF clinics routinely replace multiple (three to four) embryos into the uterus to increase the chances of a successful pregnancy. For couples who have less than three quality embryos for transfer, blastomere separation could be of benefit." [<http://www.hekim.net/~erenus/20002001/asistedreproduction/micromanipulation/embryo_multiplication.htm>].
See also, "New Ways to Produce Identical Twins -- A Continuing Controversy": "Identical twins occur naturally approximately 3.5 times out of every 1000 human births. And, to date, scientists still don't know why and can't predict that they will, in any given birth, occur. However, in the last half of this century, and indeed, in the past ten to fifteen years, scientific advances have impacted on twins and other multiples and their families in numerous ways. ... Now, a new method of actually producing identical twins looms near. Called "blastomere separation" (the separation of a two- to eight-cell blastomere into two identical demi-embryos), it is potentially one method of helping infertile couples have children through in vitro fertilization (IVF). ... The following is excerpted from the medical journal Assisted Reproduction Reviews, May 1994. Dr. Joe B. Massey, who heads an in vitro clinic in Atlanta. Dr. Massey reviews the advances in blastomere separation and discusses the potential indications, benefits, limitations, and ethics of using this method to produce monozygotic twin embryos for IVF patients. The Twins Foundation, by presenting Dr. Massey's material for your information neither advocates nor rejects any such procedures: 'Embryo Multiplication by Blastomere Separation-One Doctor's Proposal [Massey]: In spite of many advances in human in vitro fertilization (IVF), there are still many problems. While leading clinics now have success rates of about 30%, many other clinics lag behind. Still, the number of couples undergoing IVF continues to increase despite high costs.' ... According to Dr. Massey, 'Observations on the potential impact of removing less than half of the cells from the human embryo have been well documented in pre-clinical embryo biopsy studies.'
(For more on this story see Research Update Vol. 9, No. 1, 1994)." [on THE TWINS FOUNDATION (<http://twinsfoundation.com/ru-v9n1-1994.htm>)].
See also "embryo self-selection": "The ability to grow embryos for five days to the blastocyst stage of development in the laboratory, rather than the traditional three days, allows clinicians to determine with greater certainty which embryos are really the "best" in terms of their potential for implantation. Consequently, blastocyst culture makes it possible to select the best one or two blastocysts vs. three or four early embryos to transfer back to the mother. Fertility centers like Shady Grove constantly strive to improve IVF success rates through the steady refinements of clinical and laboratory techniques. Clinical blastocyst culture and transfer is the next important step in that evolution,' explains Robert Stillman, MD: 'After five days of growth, the cells of the embryo should have divided many times over, and have begun to differentiate by function. The embryos that survive to this stage of development are usually strong, healthy, and robust. ... Simply put, this self selection can be viewed as 'survival of the fittest. ... Which ones to transfer? Which ones are really the "best'? Two additional days in the blastocyst culture medium allows the natural winnowing process to continue. Thus, after 5 days of growth in the laboratory, only 2 or 3 of the original ten embryos may remain viable. We now know the best embryos to transfer. ... In thinking of the example above, patients who have fewer oocytes retrieved, fewer fertilized or fewer dividing embryos by day three in culture have no advantage using blastocyst culture, since little is to be gained in further embryo 'self selection'. Dr. Stillman emphasizes." [on FERTILITY NETWORK (<http://fertilitynetwork.com/articles/articles-blastocyst.htm>)]
ETHICS COMMITTEE OF THE AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE, "'Ethical Considerations of Assisted Reproductive Technologies': Originally published as a supplement to the ASRM medical journal (Fertility and Sterility 1994;62:Suppl 1), Ethical Considerations for Assisted Reproductive Technologies covers the American Society for Reproductive Medicine's position on several aspects of reproductive medicine, including: ... the moral and legal status of the preembryo, ... the use of donor sperm, donor oocytes and donor preembryos, ... the cryopreservation of oocytes and preembryos, micro techniques such as: zona drilling, microinjection, blastomere separation (cloning), and assisted hatching." [<http://www.asrm.com/Media/Ethics/ethics94.html>].
See also: "Because early embryonic cells are totipotent, the possibility of splitting or separating the blastomeres of early preimplantation embryos to increase the number of embryos that are available for IVF treatment of infertility is being discussed. Because embryo splitting could lead to two or more embryos with the same genome, the term "cloning" has been used to describe this practice. ... Splitting one embryo into two or more embryos could serve the needs of infertile couples in several ways. For couples who can produce only one or two embryos, splitting embryos could increase the number of embryos available for transfer in a single IVF cycle. Because the IVF pregnancy rate increases with the number of embryos transferred, it is thought that embryo splitting when only one or two embryos are produced may result in a pregnancy that would not otherwise have occurred. For couples who produce more than enough embryos for one cycle of transfer, splitting one or more embryos may provide sufficient embryos for subsequent transfers without having to go through another retrieval cycle, thus lessening the physical burdens and costs of IVF treatment for infertility. In addition, this technique may have application in preimplantation genetic diagnosis. ... Whereas these ethical concerns raise important issues, neither alone nor together do they offer sufficient reasons for not proceeding with research into embryo splitting and blastomere separation. ... In sum, since embryo splitting has the potential to improve the efficacy of IVF treatments for infertility, research to investigate the technique is ethically acceptable. Persons asked to donate gametes or embryos for such research should be fully informed that research in embryo splitting is intended or planned as a result of their donation. The fears of possible future abuses of the technique are not sufficient to stop valid research in use of embryo splitting as a treatment for infertility. This statement was developed by the American Society for Reproductive Medicine's Ethics Committee and accepted by the Board of Directors on December 8, 1995. [ on AMERICAN SOCIETY OF REPRODUCTIVE MEDICINE (<http://www.asrm.com/Media/Ethics/embsplit.html>)].
 "Like all normal somatic (i.e., non-germ cells), the primordial germ cells contain 23 pairs of chromosomes, or a total of 46 [and thus could be cloned by nuclear transplant] " [Larsen 1998, p. 4]. "A subset of the diploid body cells constitute the germ line. These give rise to specialized diploid cells in the ovary and testis that can divide by meiosis to produce haploid gametes. [Strachan and Read 1999, p. 28]. "Meiosis is a special type of cell division that involves two meiotic cell divisions; it takes place in germ cells only. Diploid germ cells give rise to haploid gametes (sperms and oocytes)." [Moore and Persaud 1998, p. 18]. "In a mitotic division, each germ cell produces two diploid progeny that are genetically equal." [Carlson 1999, p. 2]. "Future somatic cells thereby lose their totipotency and are liable to senescence, whereas germ cells regain their totipotency after meiosis and fertilization [and therefore could undergo regulation to produce new embryos]." [O'Rahilly and Muller 2001, p. 39]. "Early primordial germ cells are spared; their genomic DNA remains very largely unmethylated until after gonadal differentiation and as the germ cells develop whereupon widespread de novo methylation occurs." (emphases added) [Tom Strachan and Andrew Read, Human Molecular Genetics 2 (2nd ed.) (New York: Wiley-Liss, 1999), p. 191]
 "The term 'clones' indicates genetic identity and so can describe genetically identical molecules (DNA clones), genetically identical cells or genetically identical organisms. Animal clones occur naturally as a result of sexual reproduction. For example, genetically identical twins are clones who happened to have received exactly the same set of genetic instructions from two donor individuals, a mother and a father. 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." (emphases added) [Strachan and Read 1999, pp. 508-509]
 See especially, Tom Strachan and Andrew P. Read, Human Molecular Genetics (New York: Wiley-Liss, 1999), pp. 539-541: "From the ethical point of view, an important consideration is to what extent technologies developed in an attempt to engineer the human germline could subsequently be used not to treat disease but in genetic enhancement. There are powerful arguments as to why germline gene therapy is pointless. There are serious concerns, therefore, that a hidden motive for germline gene therapy is to enable research to be done on germline manipulation with the ultimate aim of germline-based genetic enhancement. The latter could result in positive eugenics programs, whereby planned genetic modification of the germline could involve artificial selection for genes that are thought to confer advantageous traits. ... The implications of human genetic enhancement are enormous. Future technological developments may make it possible to make very large alterations to the human germline by, for example, adding many novel genes using human artificial chromosomes (Grimes and Cooke, 1998). Some people consider that this could advance human evolution, possibly paving the way for a new species, homo sapientissimus. To have any impact on evolution, however, genetic enhancement would need to be operated on an unfeasibly large scale (Gordon, 1999). ... Even if positive eugenics programs were judged to be acceptable in principle and genetic enhancement were to be practiced on a small scale, there are extremely serious ethical concerns. Who decides what traits are advantageous? Who decides how such programs will be carried out? Will the people selected to have their germlines altered be chosen on their ability to pay? How can we ensure that it will not lead to discrimination against individuals? Previous negative eugenics programs serve as a cautionary reminder. In the recent past, for example, there have been horrifying eugenics programs in Nazi Germany, and also in many states of the USA where compulsory sterilization of individuals adjudged to be feeble-minded was practiced well into the present century." (emphases added)
 Peter Singer, "Taking life: abortion", in Practical Ethics (London: Cambridge University Press, 1981), p. 118. See also: Helga Kuhse and Peter Singer, "For sometimes letting - and helping - die", Law, Medicine and Health Care 3(4), 1986: pp. 149-153; also Kuhse and Singer, Should the Baby Live? The Problem of Handicapped Infants (Oxford: Oxford University Press, 1985), p. 138; Peter Singer and Helga Kuhse, "The ethics of embryo research", Law, Medicine and Health Care 14(13-14), 1987. For one reaction, see Gavin J. Fairbairn, "Kuhse, Singer and slippery slopes", Journal of Medical Ethics 14 (1988), p. 134.
 See Dianne N. Irving, "Science, philosophy, theology - and altruism: the chorismos and the zygon", in Hans May, Meinfried Striegnitz, Philip Hefner (eds.), Loccumer Protokolle (Rehburg-Loccum: Evangelische Akademie Loccum, 1996); Etienne Gilson, Being and Some Philosophers (Toronto: Pontifical Institute of Mediaeval Studies, 1949); Frederick Copleston, A History of Philosophy (New York: Image Books, 1962); Leonard J. Eslick, "The material substrate in Plato", in Ernan McMullin (ed.), The Concept of Matter in Greek and Medieval Philosophy (Indiana: University of Notre Dame Press, 1963); Frederick Wilhelmsen, Man's Knowledge of Reality (New Jersey: Prentice-Hall, Inc., 1956), esp. Chaps. 2 and 3. For an excellent explanation of the difference between basing "personhood" on just functionality vs. the kind of nature possessed, see Kevin Doran, "Person -- a key concept for ethics", Linacre Quarterly 56 (4), 1989, 39.
 See D. N. Irving, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (doctoral dissertation) (Washington, D.C.: Georgetown University, 1991). A short version of the dissertation can be found in D. N. Irving, "Philosophical and scientific expertise: An evaluation of the arguments on 'personhood'" (Linacre Quarterly, Feb. 1993, 60:1:18-46). [Copy submitted to this Committee for the official record.]
 Peter Singer, "Heavy Petting" [ http://www.nerve.com/Opinions/Singer/heavyPetting//].
 Richard G. Frey, The ethics of the search for benefits: Animal experimentation in medicine", in Raanan Gillon (ed.), Principles of Health Care Ethics (New York: John Wiley & Sons, 1994), pp. 1067-1075.
 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report (Washington, D.C: U.S. Department of Health, Education, and Welfare, 1978); The National Research Act, Public Law 93-348, 93rd Congress, 2nd session (July 12, 1974); 88 STAT 342. See also, Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998); also, 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); D. N. 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. [Copy submitted to this Committee for the official record.] This writer has one of her two doctoral concentrations in bioethics from the Kennedy Institute of Ethics, Georgetown University (1991). See also my doctoral dissertation, note 25, supra.
 See, e.g., E.g., Tom Beauchamp and James Childress, Principles of Biomedical Ethics (1st ed.) (New York: Oxford University Press, 1979), pp. 45-47; Tom Beauchamp and LeRoy Walters (eds.), Contemporary Issues in Bioethics (2nd ed.) (Belmont, CA: Wadsworth Publishing Company, Inc., 1982), p.26; Tom Beauchamp, Philosophical Ethics (New York: McGraw-Hill Book Company, 1982, pp. 124-128, 141, 188-190; Tom Beauchamp; and Laurence B. McCullough, Medical Ethics: The Moral Responsibilities of Physicians (New Jersey: Prentice-Hall, Inc., 1984), pp. 13-16, 21-22, 39-40, 46, 48, 133-35, 162-64.
 E.g., The Hastings Center's Daniel Callahan conceded in the 25th anniversary issue of The Hastings Center Report celebrating the "birth of bioethics", that the principles of bioethics simply had not worked. But not to worry, he said, we might try communitarianism now: "The range of questions that a communitarian bioethics would pose could keep the field of bioethics well and richly occupied for at least another 25 years"! (emphases added) [Daniel Callahan, "Bioethics: Private Choice and Common Good", Hastings Center Report (May-June 1994), 24:3:31].
 "A fairly widespread perception exists, both within and without the bioethics community, that the prevailing U.S. approach to the ethical problems raised by modern medicine is ailing. Principlism [bioethics] is the patient. The diagnosis is complex, but many believe that the patient is seriously, if not terminally, ill. The prognosis is uncertain. Some observers have proposed a variety of therapies to restore it to health. Others expect its demise and propose ways to go on without it.", Albert Jonsen, in Edwin DuBose, Ronald Hamel and Laurence O'Connell (eds.), A Matter of Principles?: Ferment in U.S. Bioethics (Valley Forge, PA: Trinity Press International, 1994), p.1. See also: Gilbert C. Meilaender, Body Soul, and Bioethics (Notre Dame, IN: University of Notre Dame Press, 1995), p. x; Raanan Gillon (ed.), Principles of Health Care Ethics (New York: John Wiley & Sons, 1994) -- in which 99 scholars from around the world jump into the fray over bioethics -- by far the majority of them arguing against bioethics "principlism"; Renee Fox, "The Evolution of American Bioethics: A Sociological Perspective," in George Weisz (ed.), Social Sciences Perspective on Medical Ethics (Philadelphia: University of Pennsylvania Press, 1990), pp. 201-220. Renee Fox and Judith Swazey, "Medical Morality is Not Bioethics -- Medical Ethics in China and the United States," Perspectives in Biology and Medicine 27 (1984):336-360, in Jonsen p. 358; Renee C. Fox and Judith P. Swazey, "Leaving the Field", Hastings Center Report (September-October 1992), 22:5:9-15.
 Original Hastings Center scholar Robert Morison, in Jonsen (pp. 109-110). As Jonsen noted, "Morison's letter was a sobering reminder of the anomalous role of an 'ethics commission' in a pluralistic, secular society."