"Open Memorandum to Sen. Venables (Delaware): Irving Does Not Support SB 80 Cloning/IVF Bill"

Dianne N. Irving
Dianne N. Irving, M.A., Ph.D.
Copyright June 25, 2005
Reproduced with Permission

"Open Memorandum to Sen. Venables (Delaware): Irving Does Not Support SB 80 Cloning/IVF Bill"

TO: Senator Robert L. Venables (D)
Post Office Box 1401
Dover, DE 19903

FROM: Dr. Dianne N. Irving, M.A., Ph.D.
5108 Randall Lane
Bethesda, MD 20816

RE: Dr. Irving Does Not Support Delaware SB 80

DATE: June 25, 2005

Dear Senator Venables:

Although I have never had the pleasure or opportunity of meeting or speaking with you, I am familiar with your distinguished service as a Senator of the State of Delaware, and of your traditional positions which safeguard the inherent dignity of all human beings. With all due respect, however, it has come to my attention that you have recently cited my work as supportive of your bill SB 80 (The Delaware Regenerative Medicine Act) which just passed the Delaware Senate, and which is about to be voted on this coming week in the Delaware House. It is necessary, therefore, for me to attempt to clarify immediately my position on SB 80, as well as that of Dr. Jean Guilfoyle with whom you have met and who conveyed to you some of my articles.1 It is clear that you, or someone who has advised you, have seriously misinterpreted my articles and what my position would be on SB 80.

Please be advised that neither of these two articles provided to you could possibly have been interpreted in any way whatsoever so as to support a bill such as SB 80, and since Dr. Guilfoyle is familiar with my writings she would have never given you that impression. Indeed, my work for the last 20 years in these issues would argue exactly the opposite. The bill is fatally flawed, and would open the legal doors to both "therapeutic" and "reproductive" human cloning and human genetic engineering in the State of Delaware. It would also greatly endanger women (and men) patients in IVF centers, as well as those patients hoping for "stem cell therapies" -- none of whom could possibly provide legally valid informed consent to participate in any activities so legalized by this bill.

I realize that your intentions to help are sincere, but please allow me to indicate further just some of the concerns I have with this bill.

FIRST, I notice that the title of the bill -- "The Delaware Regenerative Medicine Act" -- appears to take its name from that of the center recently established in California by Proposition 71 and lobbied hard for by those such as physician Irving Weissman: i.e., The Institute for Regenerative Medicine. (Weissman was also the chairman of two recent major committees at the National Academy of Sciences: their committee on stem cell research, and their committee on human cloning. This has obvious implications for the committees noted in the Delaware bill). It needs to be pointed out that certain unique and idiosyncratic "scientific" definitions inherent in those same efforts seem to have found their way into the Delaware bill. Please let me explain.

Weissman (and others) are especially noted for arbitrarily redefining the techniques used as well as the products of both sexual and asexual human reproduction so that such research would be more palatable to the public. For example, it is claimed that there is no such thing as "therapeutic" cloning per se. The technique of "nuclear transfer" [which happens to be only one of many kinds of human cloning techniques possible!] is not really "cloning" if the intention of the researcher is simply to use the product in research rather than to implant it. Similarly, the product of "nuclear transfer" is defined as just a "stem cell" which develops into an "embryo" that is just a "ball of stem cells". If the only thing involved is "stem cells", then they can claim that all they are doing is "stem cell research" and not cloning. This is very deceptive for the public, because now some kinds of cloning aren't cloning any more, and the "embryo" produced is just a ball of cells rather than a real living human being. Worse, the very term "human embryonic stem cell research" equivocally includes stem cells derived from human embryos produced not just by fertilization (e.g., IVF) but also those from human embryos produced by cloning (i.e., all cloning techniques). Yet the public is unaware of this massive deception, and I will indicate momentarily how it has slipped into the Delaware bill itself.

It needs to be said that this "science" is scientifically absurd on its face and rejected by mainstream scientists. "Nuclear transfer" is cloning -- regardless of the intentions of the researcher. It has also been known for over a hundred years (Wilhelm His' Human Embryology 1880-1885)2 that the immediate product of fertilization is a single-cell human organism, an individual human being. It is not just a "stem cell". This is how we all looked at that stage of development! The very same is true for the single-cell human organism produced by any asexual method (including "nuclear transfer").3 Whether produced sexually or asexually, these single-cell living human beings are indeed at Stage One in the Carnegie Stages of Early Human Development, and acknowledged as such by THE scientific experts on this issue -- the 20-23 Ph.D. human embryologists from around the world who sit on the international nomenclature committee on human embryology.4 These early human embryos are already human beings, not "potential" human beings. There is no such thing in the real world as an "intermediate human being". This arbitrary "science" is nothing more than a clever substitute for the passé term "pre-embryo", now formally rejected by the international nomenclature committee.

The same is accomplished by the Californians with their arbitrary definition of the term "reproductive cloning". According to them, "real" cloning is only reproductive cloning; and "reproductive cloning" is defined not only in terms of the intention of the researcher to implant the "ball of cells", but also requires its intentional birth! Thus for them there is no human being present until after birth! This too is not only scientifically absurd on its face, it is very dangerous for women, not to mention the developing child in utero. Researchers could thus experiment on the developing sexually or asexually produced child through nine months in utero without being legally liable for performing reproductive cloning if the child is not intended or allowed to be born. This deception too has slipped into the Delaware bill.

SECOND, one wonders why there is a definition of "cloning" -- and just of "reproductive" cloning -- in a bill that is purported to be just about "stem cell research" and "regenerative medicine"? If all that is involved in the bill is the use of "stem cells" from IVF human embryos (sexually produced by fertilization), then there is no need for any cloning definition in the bill. In fact, this is a human cloning bill attempting to disguise itself to the public as a stem cell research bill.

The following is the bill's formal legal definition of "reproductive" cloning:

Section 1, Chapter 30D, §3001D (a): As used in this section, 'cloning of a human being' means the practice of creating or attempting to create a human being by transferring the nucleus from a human cell from whatever source into a human egg cell from which the nucleus has been removed for the purpose of implanting the resulting product to initiate a pregnancy that could result in the birth of a human being. (emphases added)

Aside from other more subtle problems with this language, (1) "therapeutic" cloning is not included in the bill's formal definition of "cloning" -- and hence would not be covered by the bill. And this applies to the use of any human cloning technique (e.g., "twinning", pronuclei transfer, etc.) -- not just to "nuclear transfer". In fact, the term "nuclear transfer" can apply to the cloning of any diploid cell -- and that would include both somatic cells and germ line cells. So in the real world, this bill would not prohibit the use of any kind of human cloning technique as long as the "product" was intended only for research purposes. This is exactly the kind of "science" lobbied for by many involved in California Proposition 71 discussed above.

(2) "Reproductive" cloning itself is defined in such a way as to apply to only the "nuclear transfer" cloning technique. Therefore, although the bill purportedly prohibits "reproductive cloning", it only prohibits one kind of reproductive cloning: "nuclear transfer". It would not prohibit all other kinds of reproductive cloning. This also follows the California "science".

(3) "Reproductive" cloning is (absurdly) defined according to the purpose or intention of the researcher, so if the researcher did not "intend" to perform reproductive cloning then he or she would not be legally liable if it happened without so intending it. And this would apply to the use of all kinds of reproductive cloning techniques. This also follows the California "science".

(4) "Reproductive" cloning is defined as inclusive of the "birth" of the "product" -- only after which the "product" would be a human being. Thus before its birth, the product of reproductive cloning would not be considered a human being, and hence experimenting on these human embryos and fetuses would not be considered human embryo research, human fetal research, or human reproductive cloning -- nor would the researchers be held legally liable for performing any such research. This also follows the California "science".

THIRD, §3002D concerns "human embryonic stem cell research", where:

(1) The stem cells were derived from human embryos that have been donated from in vitro fertilization clinics, were created for the purposes of fertility treatment, and ... ". (emphases added)

At first glance the bill seems to be addressing "stem cell research" involving stem cells derived from human embryos produced by fertilization in vitro in these clinics. But on closer examination the bill is legally providing for much more.

(1) As might have been gleaned by the fact that a definition of "cloning" is included in this bill, the term "human embryonic stem cell research" now includes stem cells derived from human embryos produced by cloning (all cloning techniques) as well as from human embryos produced by fertilization. Thus this bill is legalizing the use of "nuclear transfer" (and all other human cloning techniques) in the guise of "human embryonic stem cell research".

(2) In no place in this bill is the term "human embryo" defined, or when a human embryo begins to exist. And if the human embryo is assumed to be defined California-style as just a "ball of stem cells" or as a "group of cells" (but not as an already existing human being, a human organism), then no human beings are legally killed in the process of deriving any of these stem cells. Only balls of stem cells are destroyed.

(3) Consequently, IVF clinics will now be legally permitted to clone human embryos, using any human cloning techniques, for both research and for reproductive purposes. That is, IVF clinics will become centers for human cloning and other genetic engineering experiments, which could include the implantation of these experimental human embryos into women for purely research purposes, as well as for "infertility treatments" (already done around the world)

(4) Because of the gross scientific misinformation inherent in this bill, legally valid informed consent would be impossible -- not only for the women "donating" their embryos or accepting them for "infertility treatments", but also for patients into whom these "stem cells" will be injected as "regenerative medical therapies".

CONCLUSION: Hopefully, Senator Venables, the preceding brief discussion will help you understand not only that my articles could not in any way be used to support your position or Delaware Bill SB 80, but also why. As a Senator who is known and respected for unequivocally valuing the inherent dignity of every human being, I pray that you would reconsider your position and remove this bill from consideration. If you have any questions, please feel free to contact me.


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

1 The articles referred to are: Irving, "What Human Embryo? Funniest Mental Gymnastics from Medicine and Research" (Oct. 14, 2004), at: http://www.lifeissues.net/writers/irv/irv_82whathumanembryo1.html; and Irving, "Playing God by manipulating man: Facts and frauds of human cloning" (October 4, 2003), presented twice at the Missouri Catholic Conference Annual Assembly Workshop, Jefferson City, MO, at: http://www.mocatholic.org/uploads/IrvingCloning3.pdf; and http://www.lifeissues.net/writers/irv/irv_22manipulatingman1.html. See these articles for extensive scientific documentation and references supporting my discussion in this Memorandum. They are all in concert with the international nomenclature committee on human embryology. [Back]

2 See endnote 4 below. [Back]

3 E.g., "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." (emphases added) Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (New York: John Wiley & Sons, Inc, 1999), pp. 508-509. [Back]

4  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 [Back]