Update on Scientific Definitions For Use In Legislation On Human Cloning And Other Genetic Engineering Research

Dianne N. Irving
Copyright February 26, 2005
Reproduced with Permission

I. Introduction:

The pace of scientific research involving human cloning and other human genetic engineering experiments these days is almost dizzying - even in some sense strangely panicky. Extensive efforts have been expended to grossly politicize the scientific language used in relevant legislations and regulations which has purposefully produced confusion and friction. Whether through ignorance or malice, such use of erroneous scientific language in these bills has profound and permanent consequences for the health and well-being of both individuals and nations. To purposefully use such false science in either research (e.g., see #1 of the Nuremberg Code) or in legislation is automatically unethical and unprofessional, as it corrupts the very starting point of any further scientific, ethical, legal or social considerations which so profoundly effect so many.

There is no need to falsify the actual objective scientific facts - other than to attempt to justify what otherwise could not be justified in any civilized society. Further, the relevant legal issues seem to remain obscure to the general public as well as to many legislators themselves - i.e., that: (1) Once erroneous "science" becomes law, it ceases to be science, but instead becomes "stari decisis", legal precedent that legally must be applied by the courts to any future related issues; (2) As most of the bills state themselves, those activities not specifically articulated in a bill will not be covered by the bill. And if activities are scientifically mis-defined in a bill then the real scientific activity (correctly defined) will also not be covered by the bill.

In an attempt to clarify these problems I have previously written an article, "How to build a better human cloning bill or treaty" (at http://www.lifeissues.net/writers/irv/irv_24buildcloningbill.html), which can be accessed for the scientific references. However, as the issues and the "scientific" mis-definitions continue to change and evolve, so must any attempt at analysis or reconstruction of the accurate science to be used in legislation. Presented below is a necessary update of that effort, especially in light of the realization that human cloning - including all cloning techniques - is only one subdivision of the larger category of activities which can also reproduce human beings a-sexually: human genetic engineering (such as pronuclei transfer). Most of the "scientific" loopholes built into some cloning bills and treaties would by default not only allow various other kinds of cloning techniques not articulated to be used, but they would also allow the a-sexual reproduction of living human beings for research by means of many other kinds of genetic engineering techniques. Such human embryos could then be used for research, "therapy", and reproduction carte blanche, with no public oversight or professional/legal accountability. Most people wouldn't even know it was happening.

II. Scientific Definitions:

To prevent such "scientific" loopholes from being embedded into legislation concerning human cloning, other human genetic engineering experiments, and human embryonic stem cell research please consider the following list of carefully researched and accurate scientific definitions. [For direct quotations from extensive scientific references in concert with the international nomenclature explaining these definitions, please see my other analyses at: http://www.lifeissues.net/sub_section.php?topic=ir&subsection=bil]. To enable those concerned and involved with such legislation, please check out these scientific references for yourself, set the following definitions side-by-side with those used in any proposed legislation dealing with these issues to identify any lingering "scientific" loopholes, and publicly require those with "different" definitions to give written and signed documented proof of their proposed "scientific" definitions using the most relevant recognized international scientific authorities academically credentialed in the specific scientific fields involved. See Part III (below) for a full discussion of these definitions:

III. Discussion: What To Look For:

1. While the debates have been mis-framed in terms of "human cloning" and "human embryonic stem cell research", what has been masked is the real issue involved - human genetic engineering. That is, human cloning and HESCR are just two of many ways to go about doing human genetic engineering. "Cloning" is a sub-category of "genetic engineering". This is why so much human genetic engineering that produces new living human embryos slips through so many legislative cracks. And it is why so many of the "cloning" definitions just somehow don't seem to be "right". Thus what really needs to be legislated are total bans on the use of any techniques, including all genetic engineering techniques, that produce a new living human being (including the single-cell human embryo).

2. Not only is genetic engineering the real issue, much genetic engineering is already being accomplished using artificial genes, chromosomes, pronuclei, nuclei, sperm, oocytes and even embryos. This is why I wrote a selected bibliography on human genetic engineering using artificial materials - 31-pages of already published research studies using such artificially constructed materials, all from PubMed (see Irving, http://www.lifeissues.net/writers/irv/irv_25scientificrefer1.html]. Many of these techniques are already being used in IVF centers as "infertility treatments", but because of the deceptive language used it is almost impossible for people to realize this. So unless the use of artificially constructed materials is somehow captured in these definitions, then their use in producing new human beings will slip through that loophole.

3. This is precisely why the use of phrases like "duplicate of", "near duplicate of", "copy of", "virtually genetically identical to", to refer to the product of a cloning technique is misleading and produces loopholes, because in reality such products are genetically unique - even the products of "nuclear transfer" are genetically unique (whether using somatic cell or germ line cell nuclear transfer). They have their own unique human genome. Thus the use of such phrases in legislation would allow such cloning/genetic engineering to continue.

4. Likewise, this is why the use of phrases like "identical to an existing or previously existing human being" also provides loopholes. Precisely because these products are genetically unique and have their own unique genomes, such a genetic constitution never existed before in any human being or donor. Thus such phrases used in legislation would also allow cloning/genetic engineering to continue.

5. Many research studies use a combination of techniques to produce new human beings - both sexual and a-sexual reproduction. For example, "twinning" begins with sexual reproduction, and then when the embryo later splits a new human being (its "twin") comes into being a-sexually. Or, two different IVF embryos can be produced sexually, and then the pronuclei of one and the pronuclei of the other can be combined a-sexually in an enucleated oocyte, stimulated, resulting in a new single human being. Or, foreign genes can be added to sperms, oocytes, and even early embryos by means of DNA-recombinant germ line gene transfer or DNA-recombinant embryonic gene transfer. Once the foreign gene is introduced into a sperm or an oocyte, then these "engineered" gametes can be used in normal sexual reproduction. The embryo produced will carry those foreign genes in every one of its cells - including its germ line cells (when they appear). The same is true for an early embryo injected with foreign genes. When these embryos "grow up" and reproduce sexually, their progeny will thus carry the same foreign genes acquired a-sexually. These are just some examples of how human genetic engineering can be accomplished using a combination of both sexual and a-sexual reproductive processes. Therefore, it is not sufficient to use just the phrase "a-sexually produced" in legislation. Both a-sexual and sexual reproductive processes must be specifically identified if used to produce a new genetically engineered human being.

6. The focus must also be on the single-cell human being or embryo immediately produced, and the acknowledgement that it is an organism, not just a "cell". Indeed, this single-cell human being is Stage One in the Carnegie Stages of Early Human Development! Researchers like Irving Weissman and Michael West, our own National Academy of Sciences - even the new British regulations -- are successfully convincing people that the immediate product of either fertilization or SCNT is just a "cell" that is not an organism, and that the 5-7 day old blastocyst is just "a ball of cells" rather than an organism. They have made the very real distinction between a "cell" and an "organism" totally disappear - indeed, they have simply made the ORGANISM disappear, leaving behind only the "cell". They have also made real human cloning disappear. That is why they then try to claim that they are only using "nuclear transfer/transplantation" (a cloning technique) and deceptively calling it "stem cell research", since there is no organism involved, just "cells" - and thus they are not cloning human beings. Their only requirement is that the PURPOSE for which the technique is used is for research purposes only (i.e., that the product will not be implanted and brought to birth).

This is the same criteria ("purpose") they used to make their false distinction between "therapeutic" cloning and "reproductive" cloning. The confusion they build on is that while it is true that the immediate product of either fertilization or cloning IS a "single cell", it is a "cell with a difference", so to speak. That is, the single cell produced is BOTH a single-cell and an ORGANISM - i.e., a single-cell ORGANISM, a human being, a human embryo. We all started off as single-cell organisms; that's the way we humans are supposed to look at that stage of our human development! But the point is that it is first and foremost an organism - not "just" a cell. Unless the immediate product of genetic engineering - and its subsequent developmental stages - are specifically identified as "organisms", rather than as just "cells", the production of new living genetically engineered human beings by such research will not be effected by the legislation.

7. Again, the addition of the phrase "for purposes of ..." must also be carefully identified as loopholes. The real point is that the products of all of these techniques are new living human beings - regardless of what purposes they will be put to.

8. I (and others) have stopped using the term "zygote" to represent the immediate product of fertilization/cloning, because to do so would leave the door open for extensive human genetic engineering to produce new living human beings by means of using the human embryo and its parts BEFORE the formation of the single-cell zygote. Instead, the use of the term "embryo" is more accurate.

For example, there are at least 14 identified phases that constitute the process of fertilization. (See O'Rahilly and Carlson who identify the "embryo" as beginning before syngamy or before the formation of the zygote. All such phases would constitute Stage One human embryos). Indeed, it is most scientifically reasonable (given the empirical data) that the "embryo" is formed at the beginning of that process -- at the penetration of the oocyte by the sperm, or when artificially produced when the genetic material is similarly "appropriately organized" and activated. There must necessarily be a substance, an organism, that is undergoing and causing the entire process, and that explains the extraordinarily unique biological reactions initiated during the entire process of fertilization/cloning - biological reactions that cannot be scientifically ascribed to a mere sperm, oocyte or subcellular materials per se.

Thus the "zygote" is formed at the end of that process, after syngamy (i.e., after the crossing-over of the maternal and paternal chromosomes). Before syngamy there is still a single-cell human embryo, a human organism. Indeed, most human genetic engineering techniques use the parts of the embryo before syngamy to produce new living genetically engineered human beings (e.g., in pronuclei transfer, sometimes referred to as "hemi-cloning"). Thus, by defining the product of either fertilization or cloning as the "zygote", one leaves the door open for the human embryo to be used in destructive research before the zygote has formed.

9. The "prohibition" or "exception" clauses in legislation also provide opportunities for loopholes. Many of them are caused by using problematic terms as noted above - especially: (1) the use of the plural term "cellS" only, which would leave out of protection the SINGLE CELL EMBRYO; and (2) the use of terms such as "DNA molecules", etc., which would allow the "parts" of the single-cell embryo (e.g., genes, chromosomes, pronuclei, nuclei, mitochondria, etc.) to be used in extensive genetic engineering research. Therefore the terms used in these clauses must also be very carefully scrutinized before legally "allowing" legitimate research to continue.

Hopefully the above definitions, clarifications and discussion can be of some help to those who are seriously concerned about the confusing and dangerous directions such legislative efforts have taken - and their profound consequences.