Cloning: Legal, Medical, Ethical, and Social Issues

Dianne N. Irving
©February 12, 1998
Reproduced with Permission


Smmary of Written Testimony (edited 2-16-98)1

*(Hearing before the Subcommittee on Health and Environment of the Comnmittee on Commerce U.S. House of Representatives)
*(Emphasis used only to aid those unfamiliar with the technical terms.)
*(5 minutes allowed for oral testimony)


Chairman Bilirakis and Members of the Sub-Committee, I appreciate the invitation to testify before you today on the profound and critically important issue of human cloning, and am grateful that you are so diligently addressing and pursuing the correct information necessary upon which to ground a clear and defensible public policy in this area.

I would like to emphasize that what I have to say today is not simply a matter of my own opinion; nor is it a religious or theological position, nor grounded on any "faith" or "belief" system. On the contrary, it is based directly on fully referenced, objectively known scientific facts - scientific facts which any one can ascertain simply by going to their local library. (I have submitted xeroxed copies from many highly reputable human embryology text books to support my references.)

Many of us have been thoroughly convinced by the bioethics literature for many years now that the product of fertilization (or cloning) is not a human embryo, a human being, or a human person. However, when a human embryo or human being begins is strictly a scientific question, and should be determined by scientists. When a human person begins is a philosophical question.

Elaborate scientific arguments have been flooding the bioethics literature for some years now, positing such unscientific claims as: (1) normal pregnancy begins at implantation; (2) the human embryo is just a "blob" or piece of the mother's tissues; (3) that all of the genetic information specific for a human being is not present at fertilization, and that human embryos can give rise to teratomas or hydatidiform moles, and therefore are not even "human"; (4) that all of the cells from the outer trophoblast layer of the 5-6 day blastocyst are discarded after birth, and only the cells from the inner embryoblast layer become the adult; that totipotent cells can each develop into later individual human beings; and that twinning cannot take place after 14-days - and therefore the early human embryo/human being is not an "individual" yet, and therefore not a human "person" yet - and therefore it is really only a potential human embryo or potential human being, or a "pre-embryo"; (5) that full differentiation is only completed by 14 days; and that (6) true "personhood" is not present until "brain birth", i.e., the formation of the primitive streak, nerve-net, neocortex or whole brain integrating system.

Unfortunately, these "scientific facts" in the bioethics literature are all scientifically incorrect, and are precisely those currently used by those who want to argue that the product of cloning is just a potential human being, and therefore could be used in destructive experimental research to find cures for human diseases, etc. To determine scientifically if the human embryo produced immediately at fertilization or cloning is an already existing human being, all one has to do is count the number of chromosomes under a microscope, and observe the functions and activities immediately detectable (since, as scientists know, a thing acts or functions according to what it is). The correct scientific facts are the following.

The early human embryo is not a "blob" or piece of tissue of the mother. Normal pregnancy begins at fertilization; when the 23 chromosomes of the sperm and the 23 chromosomes of the ovum are combined at fertilization, a new, unique, living, individual, already existing human being with 46 chromosomes is formed (the number and quality specific for the human species). Although this means that the human embryo thus formed is a human being, the chromosomal make-up of the human embryo is qualitatively different from that of either the mother or the father. That is, the human embryo is genetically different from the tissues of the mother. Even in cloning, the resulting human embryo would not be absolutely genetically identical to the mother "donor". The single-cell embryo is already genetically a male or a female (or, in the case of cloning, a female); immediately specifically human enzymes and proteins are formed; specifically human tissues and organs will be formed. Virtually all of the genetic information the human being will ever have or need is present immediately at fertilization, or cloning. No genetic information is gained or lost throughout development - only the use of some information is lost through mechanisms such as methylation. This original genetic information in the single-cell human embryo then "cascades" throughout the course of human development, itself determining later human molecular information, tissue and organ formation (precisely why a skin cell is so different from a human embryo); and it does include the genetic information needed for differentiation, totipotency, and all of the processes of embryogenesis. Entities such as teratomas and hydatidiform moles do not arise from genetically normal human embryos to begin with, but from abnormal embryos (e.g., dispermy). Not all of the cells from the trophoblast layer are discarded after birth, but many from the yolk sac and allantois are incorporated into the embryo-proper as the early blood cells and the primordium of the primitive gut, and in the human adult as the median umbilical ligament and blood cells. Twinning is possible after 14-days, e.g., with fetus-in-fetu and Siamese twins. And there is no scientific physiological basis for a valid parallel between "brain death" and "brain birth", sentience or self-consciousness. Full human development, full brain integration and the actual exercising of what bioethicists call "rational attributes" or "sentience" are actually not complete until young adulthood.

"When does a human person begin", on the other hand, is a philosophical question. Only philosophical realism starts with and matches the correct scientific facts, necessarily concluding that personhood begins when the human being begins - at fertilization or cloning. If bioethics philosophical rationalism (e.g., the exercising of "rational attributes") or bioethics philosophical empiricism (e.g., the exercising of "sentience", or pain and pleasure) are the rationales for personhood, then newborns, young children, the comatose, Alzheimers and Parkinsons patients, alcoholics, drug addicts, the mentally ill and retarded, the depressed, paraplegics (e.g., Christopher Reeves) - and many of us - are not "persons" either, and thus, by the same logic, could be experimented on or so "disposed of". Arguments to that effect have already permeated the bioethics literature for many years now.

Public policy, I would think, should be based on accurate science. Scientifically we know that the immediate product of human cloning is an already existing, unique, individual, human being - the single cell human embryo - regardless of whether it is implanted or not. It is not a potential or possible human being or human embryo, nor is it a "pre-embryo; nor is it a drug. These are the correct scientific facts. Thus human cloning research essentially involves destructive human embryo research. Since research using and commercialization of human cloning uses human beings solely as illegitimate means to some one else's ends (no matter how lofty those ends), necessarily harming and destroying them, such research and commercialization is unethical, and should be totally banned.


The Immediate Product of Human Cloning is a Human Being: Claims to the Contrary are Scientifically Wrong

Full Written Testimony (edited 2-16-98)
(Emphasis used only to aid those unfamiliar with the technical terms)
(10 pages allowed for written testimony)

Chairman Bilirakis and Members of the Sub-Committee on Health and Environment, I appreciate the invitation to testify before you today on the profound and critically important issue of human cloning, and am grateful that you are so diligently addressing and pursuing the information necessary upon which to ground a clear and defensible public policy in this area.

I would like to emphasize that what I have to say today is not simply a matter of my own opinion; nor is it a religious or theological position, nor grounded on any "faith" or "belief" system. To the contrary, it is directly based on fully referenced, objectively known scientific facts - scientific facts which any one can ascertain simply by going to their local library.

The bottom-line question concerning human cloning - not just by means of nuclear transfer, but by any other technique of cloning as well - is, "What is the immediate product of human cloning"? If the product of human cloning is a tomato, a head of lettuce, a frog or a giraffe, then our concerns about using that product for destructive experimental research or for commercial purposes would be quite different than if the product of human cloning is a human being. And simply because we can do something technically does not thereby make it ethical to actually do it. Utilitarian ethics would argue that great advances could be made to cure diseases, to increase our scientific knowledge or to reap great fortunes in the commercial market place. But even goals agreed to be truly beneficent and genuinely good are simply not sufficient in the determination of what is ethical research. The means used to reach those beneficent goals must be ethical as well. If the means used involve the harm and destruction of human beings, or the denigration of their inherent human dignity, then such research and commercialization would be unethical.

A point of clarity first. The question as to when a human embryo, or human being, begins, is strictly a scientific question, and should not be relegated to bioethicists, philosophers, theologians, governmental agencies or politicians. The answer to this question is simple. There is unquestionably a scientific consensus that the life of every single individual human being begins at fertilization as a single-cell human embryo (the zygote). I have included in my written testimony scores of scientific footnotes and references, from many different, highly acclaimed and the most commonly used human embryology text books, and have included the xeroxed pages from a number of these text books with my written testimony to demonstrate this scientific fact. What is true of the product of fertilization is true of the product of human cloning.

The question as to when a human person begins is a philosophical question. I have included for the record several of my articles discussing this at length, demonstrating that 'personhood' must begin when the human being begins - at fertilization (or, cloning). I will only refer briefly to the personhood (or philosophical) issue at the end of my testimony.

Many people (including members of Congress) have been thoroughly confused by the bioethics literature that the product of fertilization - or in this case, the product of human cloning - is not a human embryo, a human being, or a human person.2 Elaborate scientific arguments have been flooding the bioethics literature for some years now, positing such unscientific claims as the following.

It is argued that fertilization (or, likewise, cloning) is not the beginning of a human embryo or of a human being; it is just a "blob" or piece of the mother's tissues. At most what is there is only a "potential" or a "possible" human being. Fr. Bedate and Dr. Cefalo agree, claiming that all of the genetic information specific for a human being is not present at fertilization, and that human embryos can give rise to teratomas or hydatidiform moles, and therefore are not even "human" at all3.

Many have argued that fertilization (or cloning) may be the beginning of a human being, but not the beginning of a human person (a philosophical or theological claim grounded on incorrect science). They literally invented a new term called the "pre-embryo" to designate the product of fertilization (and now, cloning) from fertilization to implantation (5-6 days) or the formation of the primitive streak (14-days). What is present during this early period is only a "potential" or a "possible" human person or individual - and "individuality" is required, they say, before there can be personhood. For example, Dr. Clifford Grobstein (who is an amphibian embryologist, and not a human embryologist) and Fr. Richard McCormick, S.J. (a theologian), make the "scientific" claim that a genetically human being is present at fertilization, but it is not a human individual as yet (because it could still become more than one individual), and therefore not a human person as yet - it is just a "pre-embryo". To support this scientific myth they make the following "scientific" claims. To begin its growth, the human pre-embryo divides exponentially (i.e., 1, 2, 4, 16, 32, etc.). All of the outer trophoblast cells from the 5-6 day blastocyst are discarded after birth; only the cells from the inner embryoblast layer become the future adult. Therefore, the 5-6 day blastocyst is really a "pre-embryo", not an embryo (which doesn't begin, they say, until about 14-days, or the formation of the primitive streak - others argue similarly for about 3 weeks after fertilization). Further, these early totipotent cells are only a "loose collection of cells", and "have not decided yet how many individuals they will be". And most influential, they claim that twinning cannot take place after 14-days, so 14-days must be the beginning of a human individual, and therefore, of a human person. The early human "pre-embryo", then, is not a true human embryo or a human "individual", and therefore not a true human person yet4.

This is precisely the "science", by the way, which the N.I.H. Human Embryo Research Panel referenced in their Report to ground their conclusion that the "pre-embryo", or "pre-implantation embryo" (a legitimate term they use to mean the same as the "pre-embryo"), has a "reduced" moral status - and therefore it can be used in destructive experimental research. (It is interesting that there was not even one single human embryologist present on that N.I.H. Panel5). This is also precisely the "science" currently being used in the cloning debates in Congress to argue that the product of cloning is only a potential human embryo or human being, and therefore can be used in destructive experimentation to find cures for human diseases, etc.

The Australian theologian, Fr. Norman Ford, who wrote the book, When Did I Begin?, so influential in bioethics and currently used as a scientific resource in the American pharmaceutical industry, agrees with the scientific claims of Fr. McCormick and Dr. Grobstein, adding to their "science" his own claim that full differentiation is not even completed until 14 days6. Finally, some, e.g., MacKay, Rahner, Ruff, Haring, Hans-Martin Sass, Singer and Wells - most of whom are philosophers or theologians - argue that true "personhood" is not present until "brain-birth", i.e., the formation of the primitive streak, the nerve-net, the neocortex or the whole brain integrating system7.

On the contrary, a human embryo or a human being begins at fertilization (or cloning). This human being, who is a single-cell human embryo or zygote, is not a "potential" or "possible" human being, but is an already existing human embryo, which is an already existing human being - with the "potential" or "possibility" to simply grow and develop bigger and bigger. Scientifically, there is no change in what it is, or its nature, once the single-cell human embryo or human being is formed. One can easily verify that scientifically as well (and therefore all arguments for delayed personhood are scientifically negated).

The correct scientific facts about which there is a scientific consensus are the following. Human life is biologically a continuum which has not halted or been interrupted for thousands of years. Although this continuum may be seen by some to be just a "process", it must be pointed out that there must be something there which is undergoing the "process". For example, "childhood" is a "process", yet no one would seriously argue that there is no child present which is undergoing that process. Similarly, fertilization (or cloning) is a process; but there is something which is undergoing that process. A human sperm or ovum, a kidney cell, or a liver, may be said to have human "life", but the real issue is that they are not human beings, capable themselves of directing and sustaining the continuum of human life. One could implant any of these in a uterus and they would simply rot. Only human beings can direct and sustain the continuum of human life and transmit it. Once a skin cell has been used in cloning, a change in natures has taken place. That is, it is no longer a skin cell; it has been changed into a human being. It no longer acts or functions as a skin cell; it now acts and functions as a human being (we know this scientifically). This is precisely the difference between a skin cell and the product of human cloning.

To scientifically determine if the immediate product of fertilization or cloning is a human embryo or a human being, all one has to do is count the number of chromosomes under a microscope, and particularly observe the functions and activities which are present immediately at fertilization or cloning (since scientists know that a thing acts or functions according to what it is). Fertilization or cloning does not produce a "blob" or piece of tissue of the mother, or a "drug". In fertilization, when the 23 chromosomes of the sperm and the 23 chromosomes of the ovum are combined, a new, genetically unique, living, individual, already existing single-cell human embryo or human being (the single-cell human zygote) with 46 chromosomes (the number and quality specific for the human species)8 is formed, and this human being has the capacity itself to direct all of its further growth and development. Although this means that the human embryo is an already existing human being, the chromosomal make-up of the single-cell human embryo is qualitatively different from that of either the mother or the father. That is, the genetic identity of the human embryo is different from the genetic identity of the tissues of the mother. The same would be true of the product of cloning, as the genetic make-up of the new human embryo, although an already existing human being, would be qualitatively different from the genetic make-up of the donor "mother" (due, e.g., to crossing-over of the maternal chromosomes during mitosis and cell division, environmental conditions, mutations, etc.). In fertilization, the single-cell human embryo formed at fertilization is already genetically a male or a female; in cloning, it would already be genetically a female.9 In beginning its growth, the human embryo divides asynchronously (i.e., 1, 2, 3, etc.).10

Immediately specifically human enzymes and proteins are formed (not tomato, lettuce or giraffe proteins and enzymes). Specifically human tissues and organs are formed (tomato, lettuce or giraffe tissues or organs are not formed - that is a scientific fact).11 Virtually all of the genetic information this human being will ever have or need is present immediately at fertilization or cloning. No new genetic information is gained or lost throughout development - only the use of some information is lost through mechanisms such as methylation.12 This original genetic information "cascades" throughout the course of human development, determining later molecular information, tissue and organ formation;13 and it includes the genetic information needed for differentiation,14 totipotency (in which the cells are already expressing differentiation)15 and all of the processes of human embryogenesis - sometimes even twinning. Entities such as teratomas and hydatidiform moles do not arise from genetically normal human embryos, but from abnormal embryos to begin with (e.g., dispermy).16

Further, the "pre-embryo" is a scientific myth. Scientifically we know that all of the cells from the trophoblast layer are not all discarded after birth, but many from the yolk sac and allantois are incorporated into the embryo-proper as the early blood cells and the primordium of the primitive gut, and in the human adult as the median umbilical ligament and blood cells.17 Twinning is possible after 14-days and the formation of the primitive streak - indeed, months after fertilization - e.g., with fetus-in-fetu twins and with Siamese or con-joined twins.18

The term "pre-embryo" has a very interesting history, but has now been rejected by all human embryologists, including the internationally renowned human embryologist, Ronan O'Rahilly, who himself literally developed the internationally recognized Carnegie Stages of human embryological development. O'Rahilly has published that the term "pre-embryo" is "scientifically inaccurate" and erroneous, and states in his own human embryology text book that he refuses to use the term.19 The N.I.H Panel - whose conclusions, and the grounding for those conclusions, received unusually harsh responses and reviews even within bioethics itself - gave up using the term (but retained the use of the term "pre-implantation" embryo to mean the same as the term "pre-embryo").20

The American College of Obstetricians and Gynecologist (A.C.O.G.), who along with several others have marketed the term "pre-embryo" for many years, has recently and reluctantly decided to go back to the scientifically accurate term "embryo" for the immediate product of fertilization (or cloning). A.C.O.G. also reluctantly agreed to drop its drive to define the "beginning of pregnancy" as implantation, after quite a scientific outcry from within its own membership as well as from colleagues outside of the organization. "Pregnancy" is correctly defined scientifically as beginning at fertilization.21 Unfortunately, N.I.H.'s federal OPRR regulations22 and Common Rule, which regulate the use of human subjects in research, still (in several revisions since 1981) contain the scientifically incorrect definitions of "pregnancy" as beginning at implantation (5-6 days after fertilization), and of "fetus" as also beginning at implantation (the fetal period actually does not begin until the ninth week after fertilization23). Keith Moore, also not a human embryologist, but often quoted by McCormick, Grobstein and others, has agreed in writing that the term "pre-embryo", which he had just used for the first time in the 5th edition of his human development text book, was scientifically incorrect, and that he would have it removed in the next printings.24 Even Clifford Grobstein admitted to a scientific audience that he was using frog embryology and just calling it human embryology.25

And finally, there is no scientific physiological basis for a valid parallel between "brain death" and "brain birth", "sentience" or self-consciousness.26 Full human development, especially brain and nervous system development, and full brain integration,27 and the actual exercising of what bioethicists call "rational attributes" and "sentience" are not complete until young adulthood.28

In sum, the answer to the first question, the scientific question, is simple and clear: the life of every human embryo and human being begins immediately at fertilization, or at cloning. Indeed, human cloning is essentially human embryo research. Thus cloning would be one ingenious way in which to by-pass or circumvent the current Congressional ban on human embryo research. The human embryo at fertilization or cloning is immediately an already existing, new, unique, individual human being - termed by scientists the single-cell human zygote. This is a scientific fact. And this is the way human beings are suppose to look at this stage of development. This is not a religious, theological or philosophical issue, nor a matter of any one's belief system or opinion. Any one - scientist or otherwise - who claims that this is not true or accurate, is scientifically wrong, and should be required to give extensive scientific proofs based only on the work of nationally and internationally recognized human embryologists - especially if such critically important public policy is to be explicitly based on it.

It would seem to me that public policy should only be based on the correct scientific facts. I would conclude, therefore, on scientific grounds alone, that the cloning or commercialization of any human beings should be banned - both publicly and privately - since human cloning and its commercialization necessarily and immediately produces human beings (which remain human beings whether implanted or not), and is essentially human embryo research. Human cloning and commercialization must by definition be unethical since the means used result in harm to and destruction of untold numbers of innocent human beings - human beings used solely as objects for some one else's goals - no matter how lofty those goals may be. Technology would then surely be master of man, rather than man master of technology.

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