Catholic Culture Dedication
Catholic Culture Dedication

What Human Embryo?: Funniest Mental Gymnastics from Medicine and Research

by Dianne N. Irving, M.A., Ph.D.

Description

Presentation given by Dr. Irving after the White Mass, sponsored by The Guild of Saint Luke, The Catholics Physicians of The Archdiocese of Boston on October 18, 2004. "Such is merely a very small sampling of the fate of the McCormick and Grobstein "pre-embryo" over the last 30 years. Now, instead of human embryos, human individuals, human persons, human beings, human organisms, human cloning and other human genetic engineering, we now have only "pre-embryos" or their "substitutes", "cells", "reconstructed oocytes", "infertility treatments", "near-cloning", "bio-tech inventions", and "human embryonic stem cell research". Some "mental gymnastics" those are! But at what cost?"

Publisher & Date

LifeIssues.net, December 11, 2004

I. INTRODUCTION1

Has anyone noticed lately how so many words and phrases from diverse issues and diverse fields have taken on some odd and rather funny, amusing new meanings? Sort of a "cultural phenomenon" — owed in no small measure to the French philosopher and Father of Deconstructionism Jacques Derrida who just recently passed away — perhaps! Such ingenuity should surely not go unrecognized. So I thought it would be interesting to start collecting some of these gems from time to time, just for fun! I call them "gobbledygooks."

The definition of a "gobbledygook" is an amazingly broad and rich one. For example, dictionaries give the following: GOBBLEDYGOOK: (noun) nonsense; junk; psychobabble; non sequitur; absurdity; fraud; trick. (adj.): foolish; fake; meaningless; irrational; unreal; cunning; tricky; deceitful; disingenuous; crafty, etc.

Examples of "gobbledygooks" would include: 2 + 2 = 37. Carbon is water. Chicago is in Florida. The moon is made of blue cheese. Water boils at six degrees Fahrenheit. Squares are circles. The Statue of Liberty is in the Chesapeake Bay. Napoleon was Chinese. And geese lay golden eggs. Well — you get the picture. Gobbledygooks are not just factually wrong. They fly in the face of common sense!

The field of medicine has its own "gobbledygooks" — like, handing the new mother her "product of conception", or "pregnancy begins at implantation". But what I want to share with you is a related and equally amusing list of gobbledygooks from the field of science — specifically, terms that began their lives in the early abortion debates, but have since shifted into the current ones on human cloning and human embryonic stem cell research. It constitutes, in fact, The Mystery of "The Disappearing Human Embryo". And although these gobbledygooks currently lurk mostly in the halls of research labs and pages in biotech journals, physicians and other health care workers should expect them to recycle back into the daily practice of medicine at any moment now.

II. HUMAN REPRODUCTION

Because of the time restraints, let me cut right to the core of these scientific gobbledygooks — i.e., the deconstruction of the science of human embryology for political or other purposes — especially those objective scientific facts about how and when a human being begins to exist. But first let me make the following disclaimer before I begin: None of the accurate science that I am about to present is my subjective "opinion" or "misreading" of that science; nor is it "prolife", "religious", or even "Catholic" science. Rather I will present only those "secular" objective scientific facts in concert with the long-acknowledged internationally recognized nomenclature in human embryology.2

If anyone has objective scientific facts refuting these claims, I'd like to see the xerox copies from the pages of the human embryology textbooks from which they were copied.

Human beings can be reproduced sexually (fertilization) or asexually (cloning and other genetic engineering processes). We're most familiar with sexual reproduction (fertilization) — which I'll cover briefly in a moment. And an example of asexual reproduction that we are already familiar with is naturally occurring human monozygotic twins and triplets (in vivo). Other examples of asexual reproduction that many are not familiar with include the myriad of cloning and other genetic engineering techniques now already available and being used, e.g., germ line cell nuclear transfer (GLCNT), pronuclei transfer, mitochondria transfer, twinning (cloning by embryo splitting or multiplication, now offered in IVF clinics),3 parthenogenesis, hemicloning, the use of artificial genes, chromosomes, nuclei, sperm and oocytes,4 nanocloning5 and the use of other "converging technologies",6 etc.

But whether sexually or asexually reproduced, regardless of any "definitions" of these various processes, whether by fertilization or by "cloning" or by "genetic engineering" — the point is that all of these reproductive processes result in a new genetically unique living human being — a single-cell human organism, the human embryo. And the moral point that arises from this objective scientific fact is that it is always wrong to knowingly and directly kill an innocent human being. Nor can evil can be done so good may come of it.

A. Human Sexual Reproduction (fertilization)

I realize that most of you already know the basics of human sexual reproduction — fertilization — so I'll not repeat them here this evening. But I will just touch on a few of the finer details of that process — precisely because the "devil's in the details" so to speak, and it is the details that are being deconstructed in these cloning and stem cell debates.

Among the most critical accurate scientific details to keep straight are the following, as they document that the immediate product of sexual human reproduction is a new living genetically unique single-cell human organism, human being, human embryo, human zygote, human individual — and that normal fertilization takes place in the fallopian tube (not the uterus):7 (emphases added)

Moore and Persaud (1998): "Zygote: This cell results from the union of an oocyte and a sperm. A zygote is the beginning of a new human being (i.e., an embryo)." (p. 2)

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

O'Rahilly and Muller (2001): "The zygote is characteristic of the last phase of fertilization and is a unicellular embryo." (p. 19)

Carlson (1999): "Fertilization age: dates the age of the embryo from the time of fertilization." (p. 23)

Moore and Persaud (1998): "The expression 'fertilized ovum' refers to a secondary oocyte that is impregnated by a sperm; when fertilization is complete, the oocyte becomes a zygote." (p. 2)

Larsen (1997): "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. These pronuclei fuse with each other to produce the single, diploid, 2N nucleus of the fertilized zygote. This moment of zygote formation may be taken as the beginning or zero time point of embryonic development." (p. 17)

(sexual reproduction)

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

O'Rahilly and Muller (2001): "Fertilization takes place normally in the ampulla (lateral end) of the uterine tube." (p. 31)

Moore and Persaud (1998): "The usual site of fertilization is the ampulla of the uterine tube [fallopian tube], its longest and widest part. ... Although fertilization may occur in other parts of the tube, it does not occur in the uterus. ... Human development begins when an oocyte is fertilized." (p. 34)

Carlson (1999): "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 ... .". (p. 2)

Carlson 1994: "After the eighth week of pregnancy the period of organogenesis (embryonic period) is largely completed and the fetal period begins." (p. 407)

These are the objective scientific facts in concert with the international nomenclature for human embryology, and known for over a hundred years. They are not subjective, personal, prolife, religious or Catholic "opinions".

One doesn't have to be religious or pro-life to recognize the correct science. Take the late Planned Parenthood President Alan Guttmacher, M.D., as an example. In his 1933 book Life in the Making,8 he wrote: "We of today know that man ... starts life as an embryo within the body of the female; and that the embryo is formed from the fusion of two single cells, the ovum and the sperm. This all seems so simple and evident to us that it is difficult to picture a time when it was not part of the common knowledge." How far we have digressed since then!

B. Human a-sexual reproduction (cloning, genetic engineering, etc.)

Many of the same scientific terms just addressed are also currently being deconstructed in the debates on human cloning and human embryonic stem cell research. But first let me make a quick comparison of human development after sexual and asexual reproduction — using the rough analogy of "zipping up" and "zipping down".

"ZIPPING UP": Briefly, following sexual reproduction the early human embryo grows and develops by means of multiplying its cells, and by methylating and demethylating9 the DNA in each of those cells — part of the critical natural process called "regulation".10 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, tissues, or organs the embryo needs to grow and develop at any point in time. These products then "cascade"11 throughout growth and development. The more specialized, or differentiated, a cell, the more methylated its DNA becomes. I'll refer to this process during growth and development following sexual human reproduction as a sort of "zipping up" or "programming" of the DNA of a cell. 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.

"ZIPPING DOWN": In a-sexual reproduction, many of these processes operate in reverse. For example, in using the somatic cell nuclear transfer cloning technique, one begins with a highly specialized or differentiated cell (such as a skin cell — in which some or even most of the DNA in that cell's nucleus has been "silenced"), and then one incrementally removes the methylation bars on that DNA until the DNA in that cell is in the same state of differentiation as the "fertilized egg" — resulting in a new, single-cell zygote, an organism, a single-cell embryo or human being. That is, you begin with just a "cell", but end up with a new single-cell human being! This is roughly what happened with the production of Dolly the sheep. Quoting human molecular geneticists Strachan and Read (after they described "twinning" as a form of cloning):

A form of animal cloning can also occur as a result of artificial manipulation to bring about a type of asexual human reproduction ... 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."12 (emphases added)

And as documented above, a "fertilized oocyte" is a single-cell human being — a human embryo — a single-cell human organism.

Even the proponents of human cloning admit this. Expressing disbelief that some deny that human cloning immediately produces an embryo, Van Blerkom, human embryologist at the University of Colorado, quipped: "If it's not an embryo, what is it?", and added that researchers' efforts to avoid the word "embryo" in this context are "self-serving."13 NIH cloning researcher Ron MacKay, in reaction to Irving Weissman's amazing claim that SCNT is not cloning if done for the purpose of "research" (see below), gave a similar response: ""To start with, people need a fairy tale. Maybe that's unfair, but they need a story line that's relatively simple to understand."14

It is important to note, however, that nuclear transfer is cloning — regardless of why it is performed — and that the cloned human embryo reproduced would not be "virtually genetically identical to the donor cell".15 That is, the cloned human embryo would have a different genome due to the presence in the embryo of foreign mitochondrial DNA from the enucleated oocyte used, and the lack of the mitochondrial DNA from the donor cell used — which fact is known to cause rejection reactions in the recipients16 — just one example of some of those nasty "details" usually left out of the "fairy tales".

Forget the fairy tales — they are just meant to confuse you. All you have to remember are these simple basic objective scientific facts in concert with the international nomenclature: the immediate product of both sexual and asexual human reproduction is a new living genetically unique single-cell human organism, human zygote, human embryo, human individual, human being.

So, how did all these "fairy tales" get started, anyhow?

III. THE "PRE-EMBRYO" AND "PRE-EMBRYO SUBSTITUTES"

Usually there is no single reason why things like this happen, but it is certain that historically there has been no greater harbinger of the current decay of the scientific, medical, and legal terminology than the continual persistence in the propagation of the fake scientific term "pre-embryo" and its multitudinous equally-fake "substitutes" — gobbledygooks and fairy tales of the first order.

A. The "Pre-embryo"

Long story,17 but briefly, the term "pre-embryo" was coined in the late 1960's by Richard McCormick, S.J., and Clifford Grobstein (a frog embryologist), subsequently incorporated into our governmental and private institutions, picked up by the Warnock Commission in the UK, and since then literally spread around the world. It is, in effect, the false scientific basis for all the current debates on human cloning, human genetic engineering, and human embryonic stem cell research. But the term "pre-embryo" is a false scientific term, and has been formally rejected by the international nomenclature for human embryology, along with the related term "individualization". As expressed by Swiss human embryologist O'Rahilly:

"(1) [I]t 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."18 (emphases added)

Now, there is a correct19 and an "incorrect" way to state the "pre-embryo" — although both ways are equally effective. Either way, the purpose is obvious: to reduce the "moral status" of these new living human beings. If there is no live human embryo there, but rather just a "pre-embryo", then its use in destructive research and other projects is thereby "scientifically" justified — although it must be killed with "respect", of course.

In the correct understanding of the scientifically erroneous term "pre-embryo" it is agreed that the immediate product of human reproduction is a human being; it is just not a human "person" yet. Focus is on the philosophical concept of an "individual", because only an individual can be "ensouled". Thus the immediate product of reproduction is just a "genetic individual", not a "developmental individual" — and only a "developmental individual" can be a "person" (ensouled). It can't be a "developmental individual" until after 14-days when twinning can no longer take place. Before that time it "doesn't know how many individuals it will be yet". Thus it is just a "pre-embryo" — not an embryo or a "person".

The scientific and philosophical refutations of this argument are extensive,20 yet despite the false distinctions (the first of many to come!) and the massive scientific and philosophical flaws in the "pre-embryo" claim it continues to provide the "theoretical" basis for all of the various and sundry "delayed personhood" arguments — arguments that are required to justify a "reduced moral status" of the early human embryo or fetus.

But suffice it to point out here, e.g., that it is a scientific fact that monozygotic twinning, which is a form of cloning,21 can take place after 14-days,22 and that the early human embryo is both a genetic and a developmental individual from the first moment of its existence throughout the entire continuum of human growth and development through adulthood. There is even such a continuum between monozygotic twins. And if twinning does take place it simply means that one human "developmental" individual has become two human "developmental" individuals by means of asexual human production (see Section II.B supra). Indeed, the scientific fact is that at fertilization or cloning the "matter" is already "appropriately organized", and thus ensoulment could take place! And a realist philosophical system can successfully reason back from the accurate empirical facts of human embryology to "immediate personhood".23

But right now those philosophical arguments would probably just make your eyes cross — so instead let me just "push the logic" of the "pre-embryo" and similar arguments for "delayed personhood", and see where it takes us.

First, all the early biological marker events for "delayed personhood" in bioethics24 are themselves simply arguments for "potential" human persons, because the physiological precondition for them all is the single-cell human being formed at fertilization. Second, if only those who can actively exercise "rational attributes" (e.g., thinking, knowing, consciousness, willing, choosing, communicating, etc.) and "sentience" (e.g., feeling pain and pleasure) are "persons", then you would have to agree that the following list of adult human beings are not "persons" — and thus have no ethical or legal rights or protections as "persons": Alzheimer's patients, Parkinson's patients, the mentally retarded, the mentally ill, the comatose, drug addicts, alcoholics, the frail elderly, paraplegics, those with damaged nerve disorders — in fact all mentally and physically handicapped — as well as McCormick and Grobstein themselves while they were sleeping! You would also have to agree with bioethicist and animal rights advocate Richard Frye that such adult human non-persons should be substituted for animal "persons" in destructive experimental research.25 Would you agree?

B. "Pre-embryo substitutes"

Unfortunately, this false "pre-embryo" distinction between a human being and a human person spun off an astonishing series of similarly false "distinctions" for "delayed personhood" in early bioethics — what I call "pre-embryo substitutes".

(1) For example, one can "distinguish" between the earliest human embryo and that same human embryo/fetus at some later point in development with the following: a phase sortal vs. a substance sortal; only information content there vs. information capacity there; a biological individual vs. an ontological individual; a transient nature vs. a stable human nature; a biologically integrated whole vs. a psychologically integrated whole; a biological life only vs. a personal life; an unconscious biological life vs. a conscious personal life; a lower brain life vs. a cortical brain life; "no one home" vs. "some one home"; a "zoe" vs. a "bios"'; a possible or potential human being vs. an actual human being; a possible or potential person vs. an actual human person; an object vs. a subject; a member of the human species vs. an evolving member of the human species; no "rational attributes" or "sentience" there vs. "rational attributes" or "sentience" there; no human cognition vs. human cognition, etc. Interestingly, like the term "pre-embryo" itself, literally every one of these other "distinctions" were also grounded on grossly erroneous "science".26 Even though the term "pre-embryo" is not used, the end result is the same: the "moral status" of the early human embryo/fetus is significantly reduced.

(2) The same moral conclusion can also be arrived at by simply claiming both that the human being begins at fertilization, but that the human embryo begins at the 5-7 day blastocyst stage.27 But this is a scientific contradiction; one can't have it both ways. If the immediate product of human reproduction is simultaneously a human being and a human embryo, and if the human being begins to exist at fertilization, then the human embryo begins to exist at fertilization as well.

(3) Or, one can accomplish the same thing by retaining the term "embryo", but defining it as just a "cell" or as a "ball of cells". That is, no real human being, human embryo, human individual, or human organism is there — as in the multiple Congressional testimonies of researcher Michael West (Advanced Cell Technology, Inc.):

WEST:

"The fertilization of the egg cell by a sperm leads to a single cell called the "zygote". From this first cell, multiple rounds of cell division over the first week result in a microscopic ball of cells with very unusual properties. This early embryo, called the "preimplantation embryo", has not implanted in the uterus to begin a pregnancy ... Should the embryo implant in the uterus, the embryo, at approximately 14 days post fertilization will form what is called the primitive streak; this is the first definition that these "seed cells" will form an individual human being ... ."28

Here West fails to mention that the "zygote" is not just a single "cell"; it is a single-cell organism. They simply leave off the critical term "organism" and keep the term "single cell"! Similarly, West defines the "human embryo" (blastocyst) here as just a "microscopic ball of cells", rather than as a whole human organism, a human being. Then we are "taught" that: "Seed cells will form ... . " What? There is no scientific human embryology textbook that refers to the totipotent cells of the human blastocyst as "seeds" or as "seed cells". None. (Although there are such terms that are derived from ancient gnosticism and philosophy, e.g., the Stoics and Plotinus, which later influenced certain "theologies"). And these "seed cells" will form — in the future — an "individual human being"? But the objective scientific fact is that the individual human being is already there.

Likewise, one can observe the same "reductio ad cell" language in the work of influential California physician Irving Weissman, the driving force behind California's Stem Cell Research Initiative (Proposition 71) currently pending:

WEISSMAN:

"In normal development, the fertilized egg undergoes 7-9 cell divisions to make the blastocyst, a ball of cells that has minimal specialization. ... For many the blastocyst is a ball of cells like many other cell lines from other tissues, and it would be a violation of their medical oaths not to use these cells to gain valuable medical knowledge that could translate to therapies."29

Of course, in the real world a "fertilized egg" is a single-cell organism, a human being; and the "ball of cells" is an older multi-celled human organism, a blastocyst, a human being. Indeed, the whole blastocyst is the embryo, the human being — not just the cells in the inner cell mass from which the "stem cells" are derived.30 Removing the "stem cells" from that blastocyst is to remove them from a living human being — not from just a piece of "tissue". It seems to me that it would be a violation of the medical oath to knowingly and willing kill these living innocent human beings, to practice in a scientific field that one is not academically credentialed in, and to falsify that science along the way. This scientific deconstruction is even worse than the "pre-embryo" from which it sprang. Now there isn't even a human being there any more:

IV. "PRE-EMBRYO SUBSTITUTES" IN A-SEXUAL REPRODUCTION

It is not just in the context of sexual human reproduction that the false scientific term "pre-embryo" has caused such havoc. It has now been transferred to the current debates on asexual human reproduction and other types of human genetic engineering — especially those on human cloning and human embryonic stem cell research.

A. Weissman and the "pre-embryo"

Nothing exemplifies this continuing march of the "pre-embryo" and its "substitutes" more that the following statement by Irving Weissman, where he explicitly invokes the false scientific term "pre-embryo" over and over again in order to define what he calls the process of human "non-reproductive cloning":

"We define non-reproductive human cloning as the transfer of human cell nuclei into enucleated oocytes to produce human pre-embryos without implanting the preembryos to produce a human child. Such a process would likely be used to create early pre-embryos to be used as sources of embryonic stem cells. As set out below, we would limit the use of such pre-embryos to the period before the appearance in the pre-embryo of the so-called primitive streak, which occurs 14 to 18 days after the pre-embryo's creation. This developmental stage has also been termed the blastocyst or pre-embryo. ... Various committees, in the United States and elsewhere, that have studied embryo research have concluded that the appearance of the primitive streak marks an important step in the moral status of the pre-embryo, and hence, the ethical arguments concerning pre-embryo research. ... Before the appearance of the primitive streak, the pre-embryo is not necessarily one individual —— it could lead to identical twins."31 (emphases added)

Clearly the "pre-embryo" argument was not lost on Weissman. His references to "individual" and to "identical twins" in his definition of "non-reproductive human cloning" is also a real finger-print, marking his efforts as literally grounded on the unfortunate "pre-embryo" work of McCormick and Grobstein. But if the science used to ground the "pre-embryo" — or any of its "substitutes" — is false science, then the term itself is scientifically invalid and should never be used or accepted. Yet in order to mine the living cloned human being's "stem cells", he must reduce it to just a "pre-embryo" with a "reduced moral status" so he can kill it. Otherwise such unethical research would be highly unacceptable.

B. When cloning is not cloning

But it gets worse. Watch how Weissman literally redefines the process of human cloning by using "pre-embryo substitutes". Now cloning isn't cloning if it is performed for the purpose or goal of research, i.e., to eventually derived human embryonic "stem cells" from cloned human beings. Rather, it is just "stem cell research", since all that is there are "cells":

"Human reproductive cloning would involve the deliberate production of born humans by implantation into the uterus of prepared subjects a blastocyst produced by nuclear transfer from a pre-defined donor. ... human reproductive cloning is medically dangerous and should be legally banned, but nuclear transplantation to produce human pluripotent stem cell lines is sufficiently important that it should not be banned, and should be the subject of a broad debate."32 (emphases added)

So now human cloning is not human cloning if the goal is to use the cloned human beings for research. It is just "nuclear transplantation to produce stem cells" — i.e., "stem cell research". Yet most people don't realize that mixed into those "stem cells" derived from human embryos reproduced sexually through IVF are also those derived asexually through human cloning! On the other hand, human cloning is still human cloning if the goal is to produce born humans — and note the term "born". They are very careful to include that term. That is, if the cloned human beings are not intended to be born, then they would not be performing human reproductive cloning through 9 months while the cloned human being is developing in vivo. They would still just be performing "nuclear transplantation for stem cell research". Feminists of the world beware!

Note too that both human cloning, and its use to derive "stem cells" from cloned human embryos for "stem cell research", are already legal in the State of California.33 Those laws passed in 2002 and 2001 respectively. The current pending Proposition 71 advocated by the California Stem Cell Research and Cures Initiative34 so enthusiastically endorsed and supported by Weissman et al simply allows the state to pay for such research. Prominent on the website for this California "initiative" are links to the National Institutes of Health's authoritative website for "stem cells".35 Here one can find the same deconstructed "science" in the Senate testimony of then-Director Harold Varmus, in which he defines the immediate product of human reproduction as just "totipotent stem cells" — and no human being or human organism is there until the entity is implanted and attains adulthood!36

Not surprisingly, the National Academy of Sciences' two recent reports on human cloning and on human embryonic stem cell research reached the same convoluted conclusions, with Weissman as the chairman of both NAS committees:

"The goal of stem cell research using the somatic cell nuclear transfer (SCNT) technique must be sharply contrasted with the goal of reproductive cloning, which, using a similar technique, aims to develop an embryo that is genetically identical with the donor of its genes and then implant that embryo in a woman's uterus and allow it to mature to birth."37 (emphases added)

The application of somatic cell nuclear transfer, or nuclear transplantation, offers an alternative route to obtaining stem cells that could be used for transplantation therapies with a minimal risk of transplant rejection. This procedure — sometimes called therapeutic cloning, research cloning, or non-reproductive cloning, and referred here as nuclear transplantation to produce stem cells — (p. 29) ... The preparation of embryonic stem cells by nuclear transplantation differs from reproductive cloning in that nothing is implanted in a uterus. (p. 31) ... The process of obtaining embryonic stem cells through nuclear transplantation does not involve the placement of an embryo in a uterus, and it cannot produce a new individual.38 (emphases added)

But West, Weissman and the NIH (Varmus) are hardly alone in this ruse. Take, for example, the latest attempt by ISSCR President Zon:

The head of the International Society for Stem Cell Research (ISSCR) recently urged embryonic research supporters to get the media to stop using the term "cloning" to describe the creation of the human embryos for research. ISSCR President Leonard Zon wrote in a memo, "The negative connotation of the commercial term 'therapeutic cloning,' make[s] a change in terminology necessary. Nuclear transfer should be used instead of 'therapeutic cloning.' If we use these terms consistently, the public, journals, newspapers and magazines will follow our lead and use adequate terminology," Zon added. Zon also said that the term "cloning" does not accurately describe the artificial creation of human embryos for research.39 (emphases added)

David Stevens, M.D., Director of the Christian Medical Association, takes issue with Zon's ludicrous remarks:

"A number of researchers have been trying to leverage public funds by obscuring the fact that they want to clone human embryos to get embryonic stem cells," Stevens said. "When scientists want to do something the public abhors, they simply change the terminology. They either deploy a euphemism or use technical jargon that nobody understands," Dr. Stevens explained. Stevens said that media and scientists worldwide understand that Dolly the sheep was a cloned mammal, even though the technical term for the cloning process is nuclear transfer — the euphemism Zon favors. "Are we now supposed to say Dolly the 'nuclear transfer' sheep? Did Dolly's cloning process simply create 'cells', or did it create a sheep embryo that was later born?"40 (emphases added)

Precisely! Cloning by means of "nuclear transplantation" is cloning — regardless if the technique is performed to produce embryos for research or for implantation and subsequent birth. In either case the immediate "product" is a new living human embryo.

Note too that for researchers like Weissman and other to take the skin cell of a sick adult human patient who is suffering from possible genetic diseases such as Alzheimer's, Parkinson's, diabetes, heart disease, cancer, etc. — and then to clone that sick patient's skin cell, is to purposefully reproduce disabled human embryos, allow them to grow to the blastocyst stage of development, and then kill them for their stem cells for other disabled human beings' "therapies". If it is acceptable to clone and then kill young disabled human beings, then why wouldn't it be just as acceptable to kill older disabled human beings? Remember, in the "delayed personhood" arguments, even adult disabled human beings are not "persons", thus could be substituted for "persons" in destructive experimental research.

V. THE HUMAN ORGANISM IS NOT JUST A "CELL" OR A "BALL OF CELLS"

It is time to stop a moment and take a hard look at what those like West and Weissman are scientifically claiming — i.e., that the immediate product of human reproduction — whether sexual or asexual — is just a "cell" but not an "organism"; that the 5-7 day human blastocyst is just a "ball of cells" and not an "organism". But there is a critical difference between an "organism" and its constituent "cells". Even common on-line web dictionaries understand this, e.g.:

"In biology and ecology, an organism is a living being. The phrase complex organism describes any organism with more than one cell. Characteristics common to many organisms include: movement, feeding, respiration, growth, reproduction, sensitivity to stimuli."41 ... "In biology, the cell is the fundamental structural and functional unit of all living organisms. The cell theory, first developed in the 19th century, states that all organisms are composed of one or more cells."42

Thus an "organism" is a whole being, an individual (terms used in the scientific textbooks) — even if that being is comprised of just one cell. In more mature multi-cellular organisms, each of the cells that comprise it are only "parts" of that whole being. An organism, such as the single-cell human zygote, is inherently capable of its growth and reproduction as a being; a cell can only multiply more cells, not more beings.

O'Rahilly addresses "human organisms", their distinction from just "cells", and their growth and development in his first chapter dealing with the science of human embryology. As O'Rahilly documents, the immediate product of human sexual reproduction is a single-cell organism:

"Although life is a continuous process, fertilization ... is a critical landmark because, under ordinary circumstances, a new, genetically distinct human organism is formed when the chromosomes of the male and female pronuclei blend in the oocyte. This remains true even though the embryonic genome is not actually activated until 2-8 cells are present at about 2-3 days."43 (emphases added)

Note again that even in sexual reproduction the resulting human being is "genetically distinct". The same is true, of course, in asexual reproduction. And it is precisely because the immediate product is an organism that the nomenclature committee for human embryology formally rejected the fake term "pre-embryo". As O'Rahilly put it:

"(4) it [the term "pre-embryo"] is equivocal because it may convey the erroneous idea that a new human organism is formed at only some considerable time after fertilization"44 (emphases added)

Rather, the single-cell human organism — the human being, human embryo, human individual, human zygote — simply then proceeds to grow and develop bigger and bigger.

This is the real science, not the fairy tale science.

VI. "PRE-EMBRYO SUBSTITUTES" AS "INFERTILITY TREATMENTS"

But there is more at stake. Note that not just SCNT but all forms of human cloning can be used for pure "research", for patient "therapies", and for "reproductive" purposes — e.g., for "infertility treatments". However, by camouflaging the term "cloning" with technical-sounding "substitutes", one would be hard-pressed to realize that some "infertility treatments" actually involve human cloning.45

For example, in the published study below the human oocytes from infertility patients in private IVF clinics were cloned using "nuclear transfer". Since the transfer was not done using a "somatic" cell, it is not properly defined as "somatic cell nuclear transfer" (SCNT), but rather as "germ line cell nuclear transfer" (GLCNT). Both somatic cells and germ line cells (e.g., oocytes) are diploid, therefore nuclear transfer (cloning) can be accomplished using either type of cell. The "product" of this cloning process is referred to below as a "reconstructed oocyte", and it is "activated". That means that upon activation a new genetically unique living human being — a single-cell human embryo —has been asexually reproduced by means of human cloning using the GLCNT technique.

The term "reconstructed oocyte" is simply a euphemism, or "pre-embryo substitute", for the single-cell human organism formed by cloning. It is not just an "oocyte" any more. It is a single-cell zygote, a human being. Just as Strachan and Read noted (above) that "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" when describing the Dolly experiment, so too here. A single diploid cell — an oocyte — has become a new single-cell human being by means of nuclear transfer. I question if the "informed consent" forms explained this scientific fact so that these women undergoing "infertility treatments" understood clearly and unambiguously that their own diploid oocytes had been used to asexually reproduce their own cloned children:

Fertil Steril. 2003 Mar;79 Suppl 1:677-81
"Microfilament disruption is required for enucleation and nuclear transfer in germinal vesicle but not metaphase II human oocytes".
[Tesarik J, Martinez F, Rienzi L, Ubaldi F, Iacobelli M, Mendoza C, Greco E. (Spain)] OBJECTIVE: To evaluate the usefulness of microfilament disruption before enucleation and nuclear transfer in human oocytes at different stages of maturation. DESIGN: Prospective experimental study.

SETTING: Private clinics. PATIENT(S): Infertile couples undergoing assisted reproduction attempts. INTERVENTION(S): Oocyte enucleation and nuclear transfer, activation of reconstructed oocytes. CONCLUSION(S): Microfilament disruption before enucleation is required for germinal vesicle oocytes but not for metaphase II oocytes. 46 (emphases added)

Indeed infertility researchers are eager to use any and all cloning techniques for infertility "therapies", but worry that these practices might be too controversial. Thus they attempt to narrow the definition of "cloning" to just SCNT, allowing the other cloning techniques to slip under the radar. If, for example, a bill to ban human cloning defined it only in terms of SCNT, then all other human cloning techniques would not be affected by that bill, and IVF clinics could still perform such cloning as "infertility treatments". As admitted recently by Dr. Jamie Grifo, a leading infertility researcher at New York University:

"Infertility researchers take pains to define cloning in the narrowest terms, as a process that would use the nucleus from a single mature cell and place it in a woman's egg from which the nucleus had been removed — then jolting that hybrid cell to life with electricity. No sperm need be involved, so the baby's genetic material would all come from just one person. While many infertility specialists recoil at the prospect of such 'solo' cloning, there are critical aspects of the process that could help infertile couples. A number of infertility programs across the country are working on treatments that might be called 'near-cloning'.47 (emphases added)

According to the above narrow "definition" of cloning, the transfer of nuclei from oocytes of infertile women patients to produce a "reconstructed oocyte" in the study above is not cloning! Indeed, the word "cloning" is never used in describing the study.

Thus as Weissman et al redefine some SCNT as just "stem cell research", many infertility researchers redefine other cloning techniques as just "infertility treatments" involving "near-cloning"! We are clearly talking about "reproductive cloning" here, not just "infertility treatments" — yet another example of how human cloning is being recycled back into standard medical practice as just "infertility treatments". But who's to know?

VII. "PRE-EMBRYO SUBSTITUTES" IN BIG BIO-TECH

Not only have the embryo, the human being, the human person, and cloning techniques disappeared; not only have disabled human beings who have been purposefully reproduced and then killed disappeared; not only have cloned human embryos and fetuses in utero before birth, and female patients in infertility clinics at risk of "reproductive" cloning disappeared — one can also simply do away with the whole caboodle and label it all just "biotech inventions". This was recently accomplished by the biotech industry itself in response to a Congressional amendment48 to prohibit the patenting of "human organisms":

This provision is objectionable for the following reasons: ... Since the language does not define "human organism" it could preclude patenting of many biotechnology inventions. ... The language is vague, overly broad and would jeopardize many human-derived biotechnology inventions. Among the biotech inventions that would be placed in jeopardy are stem cells and stem cell production methods, all cell and tissue therapy products and methods, including methods of making replacement tissue and organs, methods for therapeutic cloning, gene patents, transgenic animals capable of making human proteins, methods for inducing production of an exogenous protein by humans (such as gene therapy), and claims involving the in situ or in vivo formation of an active ingredient. These inventions often lead to important new products. ... The language "encompassing a human organism" creates uncertainty about the PTO's definition of a "human organism."49

Any tinkering with their biological starting points — human organisms (human embryos and fetuses) — would clearly be a disaster. And note the long list of procedures, methods, processes (including human cloning and other human genetic engineering methods) and "products" (including cloned and bioengineered human embryos) now lumped together and euphemistically redefined by them collectively as just "biotech inventions" that would also be threatened. What a whopper of a "pre-embryo substitute" that one is! What enormous weight the definition of "human organism" now bears!

VIII. "PRE-EMBRYO SUBSTITUTES" IN NON-FEDERALLY FUNDED "STEM CELL RESEARCH" — (HUMAN CLONING!)

One final example of how far the use of the "pre-embryo" and its "substitutes" has gone can be found right here "in River City". The following is a recent memo posted by a major Boston health care organization to its investigators who might be involved in the use of "non-federally funded" human embryonic stem cell research (hESC). The "pre-embryo substitute" is right up-front:

If you wish/plan to derive hESC via somatic cell nuclear transfer:

  • No federal funds can be used — special accounting and cost centers must be in place and special dedicated controlled-access space must be identified and available — contact John Fini at [email protected].

  • Submission of a protocol to the IRB is required.

  • Consultation with the Office of General Counsel is required to ascertain compliance with Massachusetts law.50

Thus in this memo "human embryonic stem cells" derived from cloned human embryos are simply slipped into the generic category of "human embryonic stem cell research" (pace Weissman et al). Obviously investigators are legally allowed to do such human cloning (aka "nuclear transfer") as long as federal funds are not used. In fact, this health care organization "partners" with Harvard University, which recently applied for permission to clone human beings.51 Unfortunately the "IRB's" will most likely approve such human cloning protocols.52 And these are the same federally-initiated IRB's that are required to use the following false scientific definitions as those stated in the current federal OHRP regulations53 for the use of human subjects in research:

§46.202 Definitions:
(c) Fetus means the product of conception from implantation until delivery.
(f) Pregnancy encompasses the period of time from implantation until delivery.

Of course, these "scientific definitions" are grossly in error. The "fetus" does not begin its development until the beginning of the 9th week post fertilization/cloning; and normal "pregnancy" begins in the fallopian tube of the woman immediately at fertilization.54 Thus these OHRP federal regulations do not cover or apply to any human embryos as "human subjects" — whether sexually or asexually reproduced, in vivo or in vitro — through 8 weeks of development. The entire "embryonic period" has disappeared! I'd call that a free-for-all, and yet one more whopper of a "pre-embryo substitute".

IX. CONCLUSION

Such is merely a very small sampling of the fate of the McCormick and Grobstein "pre-embryo" over the last 30 years. Now, instead of human embryos, human individuals, human persons, human beings, human organisms, human cloning and other human genetic engineering, we now have only "pre-embryos" or their "substitutes", "cells", "infertility treatments", "bio-tech inventions", and "human embryonic stem cell research". Some "mental gymnastics" those are! But at what cost?

The cost is high. From one "small error in the beginning", we now have not just a justification for early abortions, the use of abortifacients, embryo pre-selection, etc., but also human cloning in all its forms under multiple guises — or "pre-embryo substitutes". Ethical and legal "informed consent" is completely precluded, as is the ability to form a truly correct conscience — not to mention the destruction of several related fields of science and the importation of such nonsense into the daily practice of medicine.

But it is even worse than that. As Josef Pieper55 has wisely noted, "The place of authentic reality is taken over by a fictitious reality; my perception is indeed still directed toward an object, but now it is a pseudo-reality, deceptively appearing as being real, so much so that it becomes almost impossible any more to discern the truth." This is precisely what bothered Plato with his own contemporary Sophists. What makes the sophists so dangerous, said Plato, is that they "fabricate a fictitious reality." That the real world in which we all live can be taken over by pseudo-realities whose fictitious nature threatens to become unnoticed is truly a depressing thought. And yet this Platonic nightmare possesses an alarming contemporary relevance, for the general public is being reduced to a state where people are not only unable to find out about the truth, but also become unable even to search for it.

Now, others might think this is all very funny — just "mental gymnastics", "gobbledygooks", or "fairy tales". But it isn't. It is now reality. The way I see it is best summed up by the progenitor of French philosopher Derrida — Lewis Carroll:

"When _I_ use a word," Humpty Dumpty said in rather a scornful tone, "it means just what I choose it to mean — neither more nor less." "The question is," said Alice, "whether you CAN make words mean so many different things." "The question is," said Humpty Dumpty," which is to be master — that's all." [Through the Looking-Glass, by Lewis Carroll [Charles Dodgson]

References:

1 Much of this presentation is drawn from my recent article, "Analysis of Legislative and Regulatory Chaos in the U.S.: Asexual Human Reproduction and Genetic Engineering" (October 4, 2004), in press; presented to Guild of St. Luke, White Mass, Archdiocese of Boston, Boston, MA, Oct. 14, 2004.

2  The Carnegie Stages of Early Human Development is the basis for the Nomina Embryologica which was part of the larger Nomina Anatomica for decades until 1989. In 1999 the name was changed by the International Associations of Anatomists to Terminologia Embryologica and Terminologia Anatomica, which was published in 1999 by the IFAA and is available for sale in book or CD-Rom format at: http://www.thieme.com/SID2194056226451/productsubpages/pubid-1163116455.html. For on-line access to information about the international Nomina Embryologica Committee and the Carnegie Stages of Early Human Development, see U.S. national website at the National Museum of Health and Medicine, Armed Forces Institute of Pathology: http://nmhm.washingtondc.museum/, Human Developmental Anatomy Center; http://nmhm.washingtondc.museum/collections/hdac/index.htm, the Carnegie Collection of Embryology; http://nmhm.washingtondc.museum/collections/hdac/Carnegie_collection.htm.

The scientific quotes on human embryology herein are taken directly from the following internationally recognized human embryology textbooks in concert with the Carnegie Stages and the international nomenclature on human embryology: Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 2001): In preparing this book, the authors have made full use of the [Carnegie Embryological] Collection and of the various published studies, whether by themselves or by others, based on what George W. Corner felicitously termed that "Bureau of Standards." ... Serious work in human embryology now depends on staging and the internationally accepted system of Carnegie embryonic stages (a term introduced by the senior author) has been adopted throughout. ... A scheme of embryonic stages can be found on the inside front cover of this book. These developmental stages are indicated by superscripts throughout this book, thereby avoiding interruptions in the flow of the text. (p. ix)

Ibid, O'Rahilly and Muller (1994): Wilhelm His, Senior (1831-1904), the founder of human embryology [Fig. 1-1]. ... [H]uman embryology is scarcely more than one hundred years old. The first to study the human embryo systematically was Wilhelm His, Senior, who established the basis of reconstruction, i.e., the assembling of three-dimensional form from microscopic sections. His, who has been called the "Vesalium of human embryology," published his three-volume masterpiece Anatomie menschlicher Embryonen in 1880-85 [His, Vogel, Leipzig]. In it the human embryo was studied as a whole for the first time. ... A detailed Handbook of Human Embryology by Keibel and Mall appeared in 1910-12. Franklin P. Mall, who studied under His, established the Carnegie Embryological Collection in Baltimore and was the first person to stage human embryos (in 1914). Mall's collection soon became the most important repository of human embryos in the world and has ever since served as a "Bureau of Standards". Mall's successor, George L. Streeter, laid down the basis of the currently used staging system for human embryos (1942-48), which was completed by O'Rahilly (1973) and revised by O'Rahilly and Muller (1987). (p. 3)

Keith Moore and T. V. N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. only) (Philadelphia: W.B. Saunders Company, 1998): Schleiden and Schwann were responsible for great advances being made in embryology when they formulated the cell theory in 1839. This concept stated that the body is composed of cells and cell products. The cell theory soon led to the realization that the embryo developed from a single cell, the zygote, which underwent many cell divisions as the tissues and organs formed. (p. 12)

For more historical information on the development of these international standards, see, e.g., article on Wilhelm Hiss, at: http://www.whonamedit.com/doctor.cfm/2606.html

3  See, e.g., Cloning researcher, Geraedts JP, de Wert GM., "Cloning is possible by nucleus transplantation and by embryo splitting. Nucleus transplantation does not result in a genetically completely identical individual because the mitochondrial DNA originates from the ovum donor. Embryo splitting may be regarded as the artificial production of a monozygotic multiplet," in "Cloning: applications in humans; Technical aspects." [Ned Tijdschr Tandheelkd. 2001 Apr;108(4):145-50]; [PMID: 11383357], http://www.ncbi.nlm.nih.gov/entrez/query.fcgi ?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11383357.

Famed infertility expert, Peter R. Brinsden, "The Authority has considered the ethical and social implications of cloning by splitting embryos, since this is not covered by the Act, whereas cloning of human embryos by nuclear replacement is." ["Regulation of assisted reproductive technology: The UK experience", in Peter R. Brinsden (ed.), A Textbook of In Vitro Fertilization and Assisted Reproduction (2nd ed) (New York: The Parthenon Publishing Group, 1999)] [Bourn Hall Clinic, Cambridge, UK], p. 421.

British researcher, Dr Anne McLaren: "1.1 Cloning ... may involve division of a single embryo, in which case both the nuclear genes and the small number of mitochondrial genes would be identical, or it may involve nuclear transfer, in which case only the nuclear genes would be identical. ... 1.6 In contrast, cloning by embryo splitting, from the 2-cell up to the blastocyst stage, has been extensively used in sheep and cattle to increase the yield of progeny from genetically high-grade parents. [Opinion of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission, requested by the European Commission on 28 February 1997], http://europa.eu.int/comm/european_group_ethics/gaieb/en/opinion9.pdf.

Bioethics lawyer George Annas: "Twinning by splitting an extracorporeal human embryo in two is the most rudimentary form of human cloning, and the closest to natural twins." ["Human Cloning: A Choice or an Echo?; II. Cloning and Imagination", University of Dayton Law Review, Winter 1998, Vol. 23, Num. 2], http://www.bumc.bu.edu/www/sph/lw/pvl/html3-variant.html.

Lawyers, economists and ethicists Campbell et al: "Germ-line tinkering is the end to which these three lines of research that I mentioned earlier are headed. [Nuclear transplantation, genetic engineering, and reproductive medicine.] In 1983, when the first artificial twinning of horses was performed in this country using another type of cloning known as blastomere separation, [ftnt. 110] ethicists insisted that no one would ever attempt the procedure on humans because there was too much opposition within ethical review boards and other institutional oversight bodies to permit it. They were wrong. In 1993, Jerry Hall at George Washington University Medical Center performed blastomere separation using "genetically abnormal" human embryos. He told Science that he did it intentionally to "get the ethical discussion moving." The discussion did not "move", however, just as it did not move in the late 1960s, when scientists issued the same assurance that cloning of anything was impossible and unthinkable. We should have known better, but too often in our society, we react only to what exists. Now, we have the unthinkable and we must scramble to catch up. [ftnt. 110: In relation to cloning, blastomere separation "splits the cells or blastomeres of an early multicelled embryo before the cells have begun to differentiate. Because each blastomere at this stage is in theory totipotent (that is, capable of producing an entire organism itself), separated cells can become new embryos, all of which have the same genome." John A. Robertson, "The Question of Human Cloning", Hastings Center Report (Mar. 1, 1994), p. 6]. [P. Campbell, G. Maranto, C. R. Cantor, L. H. Glantz, and F. H. Miller, "Gene Therapy: Legal, Financial and Ethical Issues", Boston University Journal of Science and Technology Law, March 20, 1997, pp. 18-19 [http://www.bu.edu/law/scitech/volume4/4jstl03.pdf].

The Council of Europe: "The member States of the Council of Europe, the other States and the European Community Signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, ... Noting scientific developments in the field of mammal cloning, particularly through embryo splitting and nuclear transfer ...". [Human Cloning Regulation in Europe, in American Center for Law and Justice, Info Letters, CFJD MEMO, 2001-03-09], http://www.aclj.org/cloning/cloning_cfjd_europe.asp.

National Institutes of Health, Office of Science Planning and Policy: "Cloning and somatic cell nuclear transfer are not synonymous. Cloning can be successfully accomplished by using a number of different technologies." [CLONING: Present Uses and Promises, April 27, 1998], http://www1.od.nih.gov/osp/ospp/scipol/cloning.htm. See also, NIH Guidelines for Research Using Human Pluipotent Stem Cells: "If these cells separate, genetically identical embryos result, the basis of identical twinning." (p. A-3)

Australia, The Cloning of Humans (Prevention) Bill 2001 (Queensland): "The cloning of a cell or an individual may be achieved through a number of techniques, including: molecular cloning ..., blastomere separation (sometimes called "twinning" after the naturally occurring process that creates identical twins): splitting a developing embryo soon after fertilisation of the egg by a sperm (sexual reproduction) to give rise to two or more embryos. The resulting organisms are identical twins (clones) containing DNA from both the mother and the father. ... somatic cell nuclear transfer: the transfer of the nucleus of a somatic cell into an unfertilised egg whose nucleus, and thus its genetic material, has been removed. A number of scientific review bodies have noted that the term "cloning" is applicable in various contexts, as a result of the development of a range of cloning techniques with varying applications.", http://www.parliament.qld.gov.au/Parlib/Publications_pdfs/books/2001036.pdf.

(in vitro) Human molecular geneticists, Strachan and Read: "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." [Human Molecular Genetics 2 (2nd ed.) (New York: John Wiley & Sons, Inc., 1999), pp. 508-509].

(in vivo) Human embryologists, O'Rahilly and Muller: "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." [Human Embryology & Teratology (New York: Wiley-Liss, 2001, p. 37].

Human embryologist, Bruce Carlson: "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, ... " (p. 44); " ... 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." [Human Embryology and Developmental Biology (St. Louis, MO: Mosby, 1994); also, Carlson, ibid., (2nd ed., 1999), p. 49].

Human embryologist, William Larsen: "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." [Essentials of Human Embryology (New York: Churchill Livingstone, 1998), p. 325].

American Society of Reproductive Medicine: "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. ... 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 abuses of the technique are not sufficient to stop valid research in use of embryo splitting as a treatment for infertility." (http://www.asrm.com/Media/Ethics/embsplit.html).

Ethics Committee of the American Society for Reproductive Medicine: "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, ... micro techniques such as: zona drilling, microinjection, blastomere separation (cloning), and assisted hatching." ("'Ethical Considerations of Assisted Reproductive Technologies': Originally published as a supplement to the ASRM medical journal [Fertility and Sterility 1994;62:Suppl 1], http://www.asrm.com/Media/Ethics/ethics94.html.

The Twins Foundation: "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)," in "New Ways to Produce Identical Twins — A Continuing Controversy", http://twinsfoundation.com/ru-v9n1-1994.htm.

Dr. Mithhat Erenus: "In such cases, patients may benefit from embryo multiplication ... Since each early embryonic cell is totipotent (i.e., has the ability to develop and produce a normal adult), embryo multiplication is technically possible. ... 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", http://www.hekim.net/~erenus/20002001/asistedreproduction/ micromanipulation/embryo_multiplication.htm, and at http://fertilitynetwork.com/articles/articles-blastocyst.htm).

4 For an extensive 31-page summary of selected bibliography of recent research studies on PubMed using such human materials for cloning and genetic engineering, see Irving, "Scientific References, Human Genetic Engineering (Including Cloning): Artificial Human Embryos, Oocytes, Sperms, Chromosomes and Genes" (May 25, 2004), at http://www.lifeissues.net/writers/irv/irv_25scientificrefer1.html.

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

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

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

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

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

7 For full bibliographic references for these texts please see note 2 supra.

8 Alan Guttmacher, Life in the Making: The Story of Human Procreation (New York: Viking Press, 1933), p. 3.

9 See standard explanations of "methylation" in, e.g., O'Rahilly and Muller, 2001: "Cells differentiate by the switching off of large portions of their genome." (p. 39); Lewin, 2000: "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." (p. 678; also p. 603 ff); Strachan and Read, 1999: "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." (pp. 193 ff)

10 For standard explanations of "regulation", see, e.g., : (Carlson, 1999): "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." (p. 44). "... 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) " ... Some types of twinning represent a natural experiment that demonstrates the highly regulative nature of early human embryos, ... ." (p. 48) "...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); O'Rahilly and Muller, 2001: "Biopsy of an embryo can be performed by removing one cell from a 4-cell, or two cells from an 8-cell, embryo. This does not seem to decrease the developmental capacity of the remaining cells." (p. 37); Kay T. Elder, "Laboratory techniques: Oocyte collection and embryo culture" in Peter Brinsden (ed.), A Textbook of In Vitro Fertilization and Assisted Reproduction, 2nd edition (New York: The Parthenon Publishing Group, 1999): "Surprisingly, fragmented embryos, repaired or not, do implant and often come to term. This demonstrates the highly robust nature of the human embryo, as it can apparently lose over half of its cellular mass and still recover." (p. 197)

11 E.g., see Lewin, 2000: "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." (p. 63; also pp. 914, 950).

12 Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (New York: John Wiley & Sons, Inc, 1999), pp. 508-509.

13  Jonathan Van Blerkom, human embryologist at University of Colorado, in American Medical News, Feb. 23, 1998, p. 32; also, Ian Wilmut: "The majority of reconstructed embryos were cultured in ligated oviducts of sheep... Most embryos that developed to morula or blastocyst after 6 days of culture were transferred to recipients and allowed to develop to term," etc. [I. Wilmut et al., "Viable offspring derived from fetal and adult mammalian cells," 385 Nature 810-813 (Feb. 27, 1997)], and also, "One potential use for this technique would be to take cells — skin cells, for example — from a human patient who had a genetic disease... You take these and get them back to the beginning of their life by nuclear transfer into an oocyte to produce a new embryo. From that new embryo, you would be able to obtain relatively simple, undifferentiated cells, which would retain the ability to colonize the tissues of the patient." - Ian Wilmut, in 7 Cambridge Quarterly of Healthcare Ethics 138 (Spring 1988).

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

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

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

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

14 Rick Weiss, ""Stem Cells An Unlikely Therapy for Alzheimer's: Reagan-Inspired Zeal For Study Continues", Washington Post, June 10, 2004, A03, at: http://www.washingtonpost.com/wp-dyn/articles/A29561-2004Jun9.html.

15 It is important for understanding these cloning debates - especially the definitions of these processes and the "products" formed — that the human genome is not defined in terms of the nuclear genes alone, but in terms of the total DNA in the cell, including DNA found outside of the nucleus in the cytoplasm. Strachan and Read (1999): "The human genome is the term used to describe the total genetic information (DNA content) in human cells. It really comprises two genomes: a complex nuclear genome ... , and a simple mitochondrial genome ... Mitochondria possess their own ribosomes and the few polypeptide-encoding genes in the mitochondrial genome produce mRMAs which are translated on the mitochondrial ribosomes. (p. 139); In animal cells, DNA is found in both the nucleus and the mitochondria. (p. 10); The mitochondria also have ribosomes and a limited capacity for protein synthesis." (p. 18) Lewin (2000): "A genome consists of the entire set of chromosomes for any particular organism, and therefore comprises a series of DNA molecules, each of which contains a series of many genes. The ultimate definition of a genome is to determine the sequence of the DNA of each chromosome. (p. 4); ... Genes not residing within the nucleus are generally described as extranuclear; they are transcribed and translated in the same organelle compartment (mitochondrion or chloroplast) in which they reside. By contrast, nuclear genes are expressed by means of cytoplasmic protein synthesis." (p. 81) This is why the cloned human embryo reproduced by nuclear transfer is not "genetically identical" to any "existing or previously existing" human being. The importance of these facts are particularly important when used in formal definitions in laws and regulations, since if they do not specifically address something then it is not covered. Indeed, bad science simply becomes bad law, and is then perpetuated through the courts as stare decisis.

16 See, e.g.: (1) Congressional website, Cloning Basics: 101: "What is Cloning?" ... It is false to say that cloning solves the transplant rejection problem. Each embryo clone would still contain mitochondrial DNA from the egg donor; the clone is NOT an exact genetic copy of the nucleus donor, and its antigens would therefore provoke immune rejection when transplanted. There would still be the problem of immunological rejection that cloning is said to be indispensable for solving," at http://www.house.gov/weldon/issues/clone_basics.htm. (2) "Congressman Weldon's Cloning Facts", quoting testimony of Dr. Irving Weissman before the President's Council on Bioethics, "I should say that when you put the nucleus in from a somatic cell, the mitochondria still come from the host" [from the female egg] ... And in mouse studies it is clear that those genetic differences can lead to a mild but certainly effective transplant rejection and so immunosuppression, mild though it is, will be required for that", at http://www.nrlc.org/Killing_Embryos/Weldoncloningfacts022603.hrml; also at: http://www.traditionalvalues.org/pdf_files/Human_Cloning.pdf. (3) Transcript of House Hearing introducing Weldon Bill, Cliff Stearns (FL) testimony before Hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, 107th Congress, 1st Session on H.R. 1644 and H.R. 2172 (June 20, 2001), "Seven States' proposals ban the creation of genetically identical individuals, but that leaves another loophole. An egg cell, donated for cloning, has its own mytochondrial DNA, which is different from the mytochondrial DNA of the cell that provided the nucleus. The clone will, therefore, not truly be identical", at: http://energycommerce.house.gov/107/hearings/06202001Hearing291/print.htm. (4) Senator Sam Brownback, "Some proponents of human cloning claim that an embryo created in this manner will have cells that are a genetic match to the patient being cloned, and thus would not be rejected by the patient's immune system. This claim is overstated at best; in fact there are some scientific reports that show the presence of mitochondrial DNA in the donor egg can trigger an immune-response rejection in the patient being treated, in "A True Complete Ban", National Review Online, Feb. 26, 2003, at: http://www.nationalreview.com/comment/comment-brownback022603.asp. (5) Leon Kass, "Before one starts arguing the morality of embryo farming, we should know that the whole matter is science fiction. The egg containing my nucleus is not fully my genetic twin. It also contains residual DNA — mitochondrial DNA — from the woman who donated the egg. The cloned embryo and all cells derived from it remain partly 'foreign,' enough to cause transplant rejection", in The Chicago Tribune, July 31, 2001, quoted by Dave Andrusko in, "Averting a Catastrophe", at: http://www.nrlc.org/news/2001/NRL08/editA.html. (6) President's Council on Bioethics, "The technique of cloning ... bring to live birth a cloned animal that is genetically virtually identical (except for the mitochondrial DNA) to the animal that donated the adult cell nucleus", in Human Cloning and Human Dignity: An Ethical Inquiry, "Executive Summary; Fair and Accurate Terminology; Scientific Background", at: http://www.bioethics.gov/reports/cloningreport/execsummary.html. (7) George Annas, "How could such stem-cell lines be generated? One way is by transferring somatic-cell nuclei into enucleated eggs (nuclear transplantation). When stimulated to divide, the cell can form blastocysts of predefined nuclear genotype (with the mitochondrial DNA coming from the egg)", The New England Journal of Medicine, Volume 346:1576-1579 May 16, 200, "Stem Cells Scientific, Medical, and Political Issues", at: http://www.gardacuore.net/rigenerativa/ARTICOLI/NEJM_Issues.htm. [emphases added]

17  See the development of the erroneous term "pre-embryo" in the early works of, e.g., Richard McCormick, S.J., "Who or what is the preembryo?", Kennedy Institute of Ethics Journal 1:1 (1991). In this paper McCormick draws heavily on the work of frog embryologist Clifford Grobstein, as well as from "an unpublished study of a research group of the Catholic Health Association entitled 'The Status and Use of the Human Preembryo', (p. 14).

The influence of the McCormick/Grobstein term "pre-embryo" was (and still is) widespread even among Catholic scholars. In addition to the works of McCormick and Grobstein, see acceptance of the term "pre-embryo" also in: Andre E. Hellegers, "Fetal development," in Thomas A. Mappes and Jane S. Zembatty (eds.), Biomedical Ethics, (New York: Macmillan, 1981); Hellegers, "Fetal development", Theological Studies (1970), 31:3-9; Charles E. Curran, "Abortion: Contemporary debate in philosophical and religious ethics", in W. T. Reich (ed.), Encyclopedia of Bioethics 1 (London: The Free Press, 1978), pp. 17-26; Kevin Wildes, "Book Review: Human Life: Its Beginning and Development" (L'Harmattan, Paris: International Federation of Catholic Universities, 1988); Carlos Bedate and Robert Cefalo, "The zygote: To be or not be a person", Journal of Medicine and Philosophy (1989), 14:6:641; Robert C. Cefalo, "Book Review: Embryo Experimentation, Peter Singer et al (eds.); 'Eggs, embryos and ethics'", Hastings Center Report (1991), 21:5:41; Mario Moussa and Thomas A. Shannon, "The search for the new pineal gland: Brain life and personhood", The Hastings Center Report (1992), 22:3:30-37; Carol Tauer, The Moral Status of the Prenatal Human (Doctoral Dissertation in Philosophy; Kennedy Institute of Ethics, Georgetown University, Washington, D.C.: Georgetown University, 1981) (Sister Tauer's dissertation mentor was Richard McCormick; she later went on to become the ethics co-chair of the NIH Human Embryo Research Panel 1994); C. Tauer, "The tradition of probabilism and the moral status of the early embryo", in Patricia B. Jung and Thomas A. Shannon, Abortion and Catholicism (New York: Crossroad, 1988), pp. 54-84; Lisa S. Cahill, "Abortion, autonomy, and community", in Jung and Shannon, Abortion and Catholicism (1988), pp. 85-98; Joseph F. Donceel, "A liberal Catholic's view", in Jung and Shannon, Abortion and Catholicism (1988), pp. 48-53; H. Tristram Engelhardt, The Foundations of Bioethics (New York: Oxford University Press, 1985), p. 111; William A. Wallace, "Nature and human nature as the norm in medical ethics", in Edmund D. Pellegrino, John P. Langan and John Collins Harvey (eds.), Catholic Perspectives on Medical Morals (Dordrecht: Kluwer Academic Publishing, 1989), pp. 23-53; Norman Ford, When Did I Begin? (New York: Cambridge University Press, 1988), p. 298; Antoine Suarez, "Hydatidiform moles and teratomas confirm the human identity of the preimplantation embryo", Journal of Medicine and Philosophy (1990), 15:627-635; Thomas J. Bole, III, "Metaphysical accounts of the zygote as a person and the veto power of facts", Journal of Medicine and Philosophy (1989), 14:647-653; Bole, "Zygotes, souls, substances, and persons", Journal of Medicine and Philosophy (1990), 15:637-652.

See also: See Richard McCormick's testimony in The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Report and Recommendations; Research on the Fetus; U.S. Department of Health, Education and Welfare, 1975, pp. 34-35; McCormick, How Brave a New World? (Washington, D.C.: Georgetown University Press), p. 76; McCormick, "Proxy consent in the experimentation situation", Perspectives in Biology and Medicine (1974), 18:2-20; Paul Ramsey's testimony in The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; Report and Recommendations; Research on the Fetus; U.S. Department of Health, Education and Welfare, 1975, pp. 35-36.

The use of the term "pre-embryo" has been quite widespread for decades — nationally and internationally. In addition to the Catholic scholars who accepted the use of the term "pre-embryo" as noted above, a partial list of secular bioethics writers who also accepted the use of the term in these debates includes: Paul Ramsey, "Reference points in deciding about abortion" in J.T. Noonan (ed.), The Morality of Abortion (Cambridge, MA: Harvard University Press, 1970), pp. 60-100, esp. p. 75; John Robertson, "Extracorporeal embryos and the abortion debate", Journal of Contemporary Health Law and Policy (1986), 2;53;53-70; Robertson, "Symbolic issues in embryo research", The Hastings Center Report (1995, Jan./Feb.), 37-38; Robertson, "The case of the switched embryos", The Hastings Center Report (1995), 25:6:13-24; Howard W. Jones, "And just what is a preembryo?", Fertility and Sterility 52:189-91; Jones and C. Schroder, "The process of human fertilization: Implications for moral status", Fertility and Sterility (August 1987), 48:2:192; Clifford Grobstein, "The early development of human embryos", Journal of Medicine and Philosophy (1985), 10:213-236; also, Science and the Unborn (New York: Basic Books, 1988), p. 61; Michael Tooley, "Abortion and infanticide", in The Rights and Wrongs of Abortion, M. Cohen et al (eds.) (New Jersey: Princeton University Press, 1974), pp. 59 and 64; Peter Singer and Helga Kuhse, "The ethics of embryo research", Law, Medicine and Health Care (1987),14:13-14; Kuhse and Singer, "For sometimes letting - and helping - die", Law, Medicine and Health Care (1986), 3:40:149-153; Kuhse and Singer, Should The Baby Live? The Problem of Handicapped Infants (Oxford University Press, 1985), p.138; Singer, "Taking life: Abortion", in Practical Ethics (London: Cambridge University Press, 1981), pp. 122-123; Peter Singer, Helga Kuhse, Stephen Buckle, Karen Dawson, Pascal Kasimba (eds.), Embryo Experimentation (New York: Cambridge University Press, 1990); R.M. Hare, "When does potentiality count? A comment on Lockwood," Bioethics (1988), 2:3:214; Michael Lockwood, "When does life begin?", in Michael Lockwood (ed.), Moral Dilemma's in Modern Medicine (New York: Oxford University Press, 1985), p. 10; Hans-Martin Sass, "Brain life and brain death: A proposal for normative agreement," Journal of Medicine and Philosophy (1989), 14:45-59; Michael Lockwood, "Warnock versus Powell (and Harradine): When does potentiality count?" Bioethics (1988), 2:3:187-213.

See also the use of the term "pre-embryo" in many national and international documents (a small sample): Ethics Advisory Board (1979) Report and Conclusions: HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer, Washington, D.C.: United States Department of Health, Education and Welfare, p. 101; National Institutes of Health Human Embryo Research Panel Meetings (Washington, D.C.: NIH, 1994), Feb. 2 meeting, pp. 27, 31, 50-80, 85-87, 104-106; in the Feb. 3, 1994 meeting, pp. 6-55; April 11 meeting, pp. 23-41, 9-22. See also, Dame Mary Warnock, Report of the Committee of Inquiry into Human Fertilization and Embryology, (London: Her Majesty's Stationary Office, 1984), pp. 27 and 63; British House of Lords, "Human Fertilisation and Embryology (Research Purposes) Regulations 2001"; Commonwealth of Australia, Select Senate Committee on the Human Embryo Experimentation Bill, (Canberra, Australia: Official Hansard Report, Commonwealth Government Printer, 1986); Parliamentary Assembly of the Council of Europe, On the Use of Human Embryos and Foetuses for Diagnostic, Therapeutic, Scientific, Industrial and Commercial Purposes, Recommendation 1046, 1986; and On the Use of Human Embryos and Foetuses in Scientific Research, Recommendation 1000, 1989; Ethics Committee of the American Fertility Society (AFS), "Ethical Considerations of the New Reproductive Technologies", Fertility and Sterility (1986), 46:27S. See also Jonsen, esp. Chapters 4 and 12.

For scientific refutations of the false term "pre-embryo" and its "pre-embryo substitutes", see, e.g., articles by C. Ward Kischer, a Ph.D. human embryologist who has taught human embryology for over 30 years: "Stem cell research, Ron Reagan, and John Kerry", http://www.lifeissues.net/writers/kisc/kisc_07cellsearchkerry.html; "Why Hatch is wrong on human life", http://www.lifeissues.net/writers/kisc/kisc_06whywrong.html; "The corruption of the science of Human Embryology", http://www.lifeissues.net/writers/kisc/kisc_01humanembryology.html; "There is no such thing as a pre-embryo", http://www.lifeissues.net/writers/kisc/kisc_05nopreembryo.html; "Cloning, stem cell research, and some historic parallels, http://www.lifeissues.net/writers/kisc/kisc_02historicparallels.html; "The beginning of life and the establishment of the continuum", in Kischer and Irving, The Human Development Hoax: Time To Tell The Truth!, (Clinton Township, MI: Gold Leaf Press, 1995 and extensively revised and expanded second edition by co-authors (1997), pp. 4-13; "When Does Human Life Begin? The Final Answer — A human embryologist speaks out about socio-legal issues involving the human embryo". See also article by Sarah Sexton, "New Reproductive and Genetic Technologies: International versus National Campaign Issues", in The Geneticization of Health (p. 8), presentation to International IPPNW (International Physicians for the Prevention of Nuclear War) - Kongress Medizin und Gewissen (Medicine and Conscience), Erlangen, Germany, 24-27 May 2001, http://www.thecornerhouse.org.uk/document/medcon.html.

See also Irving articles refuting both scientifically and philosophically the false term "pre-embryo" indexed at PubMed: "NIH and human embryo research revisited: what is wrong with this picture?", Linacre Q. 2000 May ;67(2):8-22, PMID: 11817406, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11817406; "'New age' embryology text books: 'Pre-embryo', 'pregnancy' and abortion counseling: Implications for fetal research", Linacre Quarterly May 1994, 61(2):42-62, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652337; "Testimony before the NIH Human Embryo Research Panel", Linacre Q. 1994 Nov;61(4):82-9, PMID: 11652834, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652834; "Quality assurance auditors: how to survive between a rock and a hard place", Qual Assur. 1994 Mar;3(1):33-52, PMID: 7804617, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=7804617; "The impact of "scientific misinformation" on other fields: philosophy, theology, biomedical ethics, public policy", Account Res. 1993;2(4):243-72, PMID: 11652144, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652144; "Which ethics for science and public policy?", Account Res. 1993;3(2-3):77-100, PMID: 11652298, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11652298.

All of these articles are also accessible in full on-line at http://www.lifeissues.net/section.php?topic=ir. See also, Irving: "Fake Science and Scary Ethics of Cloning" (August 24, 2004), British Medical Journal Rapid Response to "Book Review: A Clone of Your Own? The Science and Ethics of Cloning", by Trefor Jenkins, http://bmj.bmjjournals.com/cgi/eletters/329/7463/466#71990; "The Kettles calling the Pots fake: "When is cloning not 'cloning'?"; When both sides play politics — with human lives" (July 27, 2004), http://www.lifeissues.net/writers/irv/irv_63kettle1.html; "Playing God by manipulating man: Facts and frauds of human cloning", http://www.mocatholic.org/uploads/IrvingCloning3.pdf, and http://www.lifeissues.net/writers/irv/irv_22manipulatingman1.html; "A ONE ACT PLAY: The early human embryo: 'Scientific' myths / scientific facts: Implications for ethics and public policy", Medicine and Human Dignity's "International Bioethics Conference: 'Conceiving the embryo', Brussels, Belgium (October 20, 2002), (in press, and CD-Rom), http://www.cfjd.org/www/articles/the_early_human_embryo.htm, and http://www.lifeissues.net/writers/irv/irv_11oneactdrama1.html; "Requested testimony on Canadian Bill C-13 ('Assisted Human Reproduction Act')", House of Commons (December 9, 2002), http://www.lifeissues.net/writers/irv/irv_16canadianbill.html, and http://www.clcns.com/Action%20Items.htm; "Analysis: Canadian Bill C-56", http://www.lifesite.net/features/stemcellembryo/irvingcritiquebillc56.pdf, and http://www.clcns.com/Action%20Items.htm; "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), http://www.lifeissues.net/writers/irv/irv_39anlystemcel1.html; "University Faculty for Life: Submission of Concern to the Canadian CIHR Re the 'Human Stem Cell Research Recommendations 2001'", submitted to Dr. Alan Bernstein, President, Canadian Institutes of Health Research Working Group on Stem Cell Research, Ottawa, Ontario, Canada (June 3, 2001), at: http://www.uffl.org/irving/irvcihr.htm, and http://www.lifeissues.net/writers/irv/irv_60canadiancihrrecomm1.html; "University Faculty for Life: Letter of Concern to Sen. Brownback and Congressman Weldon Re the 'Human Cloning Bill 2001'", (May 27, 2001), at: http://www.lifeissues.net/writers/irv/irv_52weldonbrownback1.html, http://www.uffl.org/irving/irvbrownback.htm; "University Faculty for Life: Submission of Concern to the British House of Lords Re the 'Human Fertilisation and Embryology (Research Purposes) Regulations 2001' submitted to Tony Rawsthorne, Select Committee, House of Lords, London (June 1, 2001): http://www.parliament.the-stationeryoffice.co.uk/pa/ld200102/ldselect/ldstem/83/8313.htm, (acknowledgment), and http://www.uffl.org/irving/irvlords.htm (full text); "When does a human being begin? 'Scientific' myths and scientific facts", International Journal of Sociology and Social Policy, 1999, 19:3/4:22-47, http://www.l4l.org/library/mythfact.html, and http://www.lifeissues.net/writers/irv/irv_01lifebegin1.html; "UFL submission to NBAC Report: Research Involving Human Biological Materials: Ethical Issues and Policy Guidance", VOLUME I Report and Recommendations of the National Bioethics Advisory Commission Rockville, Maryland August 1999 The National Bioethics Advisory Commission (NBAC), acknowledged Appendix E, p. 111; Invited Congressional testimony (oral and written), "The immediate product of human cloning is a human being: Claims to the contrary are scientifically wrong", Scientific Panel on "Cloning: Legal, Medical, Ethical, and Social Issues", Hearing before the Subcommittee on Health and Environment of the Committee on Commerce, U.S. House of Representatives, Room 2125, Rayburn House Office Building, Washington, D.C. (February 12, 1998); also in Linacre Quarterly (May 1999), 66:2:26-40, http://www.lifeissues.net/writers/irv/irv_09cloninghuman1.html; "Cloning: When word games kill", (May 13, 1998), at: http://www.lifeissues.net/writers/irv/irv_06wordgame.html; "Academic fraud and conceptual transfer in bioethics: Abortion, human embryo research and psychiatric research", in Joseph W. Koterski (ed.), Life And Learning IV (Washington, D.C.: University Faculty for Life, 1995), pp. 193-215, http://www.lifeissues.net/writers/irv/irv_10fraud1.html, and http://govinfo.library.unt.edu/nbac/hbm.pdf; "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; and Irving doctoral dissertation on this issue, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (Doctoral dissertation, Georgetown University, Washington, D.C., 1991).

18 O'Rahilly and Muller (2001), p. 88.

19 See Richard McCormick, S.J., "Who or what is the preembryo?", Kennedy Institute of Ethics Journal 1:1 (1991).

20 See note 17 supra.

21 See note 3 supra.

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)

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.

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.

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.

26 See Irving, op.cit.

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.

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.

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.

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).

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

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.

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.

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

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

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.

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.

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.

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

40 Ibid.

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

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

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

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

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

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.

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.

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:]

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.

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.

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

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.

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.

54 See accurate scientific references in note 2 supra.

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


© LifeIssues.net

Dr. Irving's professional activities include teaching positions at Georgetown University, Catholic University of America, and The Dominican House of Studies. She represented the Catholic Medical Association of the United States, and the International Federation of Catholic Medical Associations, at the Scientific Conference in Mexico City, Mexico, October 28, 1999 and presented a paper on "The Dignity and Status of the Human Embryo". Dr. Irving is a former career-appointed bench research biochemist/biologist (NIH, NCI, Bethesda, MD), an M.A. and Ph.D. philosopher (Georgetown University, Washington, D.C.), and Professor of the History of Philosophy, and of Medical Ethics.

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