Analysis of Legislative and Regulatory Chaos in the U.S.: Asexual Human Reproduction and Genetic Engineering

3. "Pre-embryo substitutes" in "fertility treatments"

As already observed, one can also create a "pre-embryo substitute" by simply sticking to the old passe definition of "cloning" like glue, and try to convince people that if the product of the cloning process is not genetically identical to an already existing human being, then it is not cloning. As with those researchers just cited, Dr. John Gearhart (Johns Hopkins University) comments on the use of SCNT for fertility treatments: "The procedure is technically the same, but the origin of the nucleus is different. In cloning, you're trying to reproduce an individual that already exists."49 However, as scientifically demonstrated at length in the analyses below, the use of any nuclear transplantation process is cloning, and the product (the human being) is not "genetically identical" to any "existing" or "previously existing" human being. It is genetically unique!

If you think that human cloning by means of SCNT is not already being performed for "fertility treatments", consider the recent research in Spain.50 Indeed infertility researchers are eager to use any and all cloning techniques for infertility "therapies", and thus they attempt to limit the damage of any pending cloning legislation by narrowing the definition of "cloning" to just SCNT. 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'."51 (emphases added)

Thus as Weissman defines SCNT as just "stem cell research", many infertility researchers define all cloning techniques as just "infertility treatments" involving "near-cloning"! We are clearly talking about "reproductive cloning" here, not just "infertility treatments". Hello?

4. "Pre-embryo substitutes" in "disease advocacy": Cloning disabled humans

Researchers are quite aware that the purposeful creation of disabled embryos with diseases such as Alzheimer's is part of the plan to "help" sick human patients:

" ... That is because the most frequently cited approach would require not just stem cells from spare embryos donated by fertility clinics -- a currently untapped source of cells that many want Bush to make available to federally funded researchers. It would also require the creation of cloned human embryos made from cells taken from Alzheimer's patients."52 (emphases added)

Indeed, as succinctly put by California research physician Irving Weissman:

This and other experiments opens the door to produce by nuclear transplantation mouse and eventually human pluripotent stem cell lines using nuclei from patients with known genetic diseases such as adult and type 1 (juvenile onset) diabetes, amyotrophic lateral sclerosis (Lou Gehrig's Disease), other neurodegenerative diseases, most cardiovascular diseases with a strong genetic component, all autoimmune diseases such as lupus or rheumatoid arthritis, allergies, etc. One might even try to use cancer stem cell nuclei to produce pluripotent stem cell lines ...53 (emphases added)

Now think about it. If nuclear transplantation is cloning, and if donor cells from diseased patients are used in the cloning process, then disabled human beings -- human embryos with diabetes, ALS, other neurodegenerative and cardiovascular diseases, autoimmune diseases (such as arthritis, allergies -- and AIDS), and cancer -- will be purposefully created by cloning, and then killed, in order "to study the process of these diseases" to find cures for other older disabled human beings. Given that cures for all these diseases are critically important and worthy goals, it is fundamentally unethical to create and then kill any human being -- especially disabled human beings -- as the means to reach those goals, especially when there are such obvious alternatives available.

And in the process of doing such research, Weissman clumsily states: "I would hope we could discover ways to process ovaries as byproducts of human tissues from surgeries so that the tens of thousands of pre-oocytes could be made into useful targets of nuclear transplantation."54 Pre-oocytes?! What text book does he find that one in? No such thing exists. It is truly amazing the extent of the manipulation of both science and the public some of these scientists are willing to go -- completely precluding any kind of ethically or legally valid "informed consent".

5. "Pre-embryo substitutes" in the big biotech bio-engineering industry

Finally, consider how the following "complaint" (discussed below) by the biotech industry completely eliminates not just the new living human beings they reproduce both sexually and asexually, but all the cloning and genetic engineering methods that reproduce them. Now they are all just "biotech inventions":

This provision [the Weldon Amendment to the U.S. patent laws] 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."55 (emphases added)

Virtually all human organisms created by them as "starting points" for obtaining their "biological materials", all procedures, techniques, methods, and "products" totally vanish into thin air as just "biotech inventions". What a whopper of a "pre-embryo substitute" this one is!

F. SCNT is not the only kind of cloning technique

What Sexton (supra) did not identify is the British Authority's scientifically erroneous definition of "cloning" only in terms of the somatic cell nuclear transfer (SCNT) technique.

This mis-definition of "cloning" would likewise have precluded the British Authority from using their "authority" to regulate any and all research involving the a-sexual reproduction of human beings by all other methods of a-sexual reproduction, at any stage of development, in vivo or in vitro, for either "therapeutic" or "reproductive" purposes -- including "twinning" (or, "embryo splitting"). The British Authority did, however, eventually address the issue of human cloning by means of "twinning", as IVF researcher Brinsden notes in the latest edition of his IVF textbook:

"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 [which they now define as not cloning if done for research purposes!] is. It has been decided not to license cloning by splitting embryos, as it considers it to be ethically unacceptable."56 (emphasis added)

Again, there are many different kinds of human cloning. As noted, the somatic cell nuclear transfer technique is only one of them. But by formally defining human cloning in a law or regulation only in terms of the SCNT technique, all other cloning techniques are thereby legally allowed. Hence such laws or regulations are not "total bans". They are at best only "partial bans", since they only "ban" cloning by SCNT.

But it can get worse. Even the SCNT cloning technique can slip through a legal loophole by simply scientifically mis-defining the product of that technique itself. For example, if the product of SCNT (the single-cell human being) is formally mis-defined in a law or regulation as being "virtually genetically identical" to the donor cell, then the real SCNT technique is thereby not covered by that law, because the real product of SCNT does not contain the mitochondrial DNA (genetic material) of the donor cell and does contain foreign mitochondrial DNA from the enucleated oocyte used. Thus the "product" is not "virtually genetically identical" to the donor cell. The same can be accomplished by defining the "product" as genetically identical to "existing or previously existing human beings", because the real product of SCNT (the single-cell human being) is genetically unique, having never existed before -- in anyone. Consequently, even the SCNT cloning technique is not banned As summed up by researchers Geraedts and de Wert:

"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."57 (emphases added)

Thus by scientifically mis-defining the product of "SCNT" in the formal definition of a law or regulation, the real human cloning technique is allowed. The end result is that such laws and regulations aren't even "partial bans". They ban, and regulate, nothing.

Why is it, then, that when individual internationally renowned expert human embryologists, human molecular geneticists, lawyers, bioethicists, economists, international multi-national organizations, national regulatory bodies, and IVF researchers and professional societies around the world all fully acknowledge the scientific facts that "twinning" is a type of human cloning technique, and that the product of SCNT is not "genetically identical to an existing or previously existing human being", some particular politicians and pressure groups -- on both sides of the aisles -- continue to insist differently, legislate accordingly -- and get away with it? There is simply no question whatsoever that "twinning" is one of many different kinds of human cloning techniques,58 and that the product of SCNT is not "virtually genetically identical" to any "existing or previously existing human being"59 -- as even admitted by those constructing these scientifically erroneous definitions admit.60 Several U.S. documents analyzed below will suffer these same defects as in their British counterparts.

G. Loopholes in the "prohibition" or "restriction" clauses

A typical section in most laws and regulations -- meant to protect quite legitimate scientific research activities -- can also be used to build subtle loopholes, e.g.:

"Nothing in this statute shall restrict areas of scientific research not specifically prohibited by this statute, including in vitro fertilization, the administration of fertility enhancing drugs, research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, tissues, organs, plants, or animals other than humans, or cells other than human embryos." (emphases added)

This would seem to be a fairly innocuous section, yet it allows extensive human cloning and human genetic engineering of new living human beings -- accomplished by using "molecules" and "parts" of cells, either naturally or artificially reproduced.

For example, DNA is, precisely, just a "molecule", which makes up a "gene", which makes up a "chromosome", which makes up a "pronuclei", which makes up a "nucleus", or is found in extra-nuclear mitochondria. These are all just "parts" of a single cell, just as many cells compose tissues, which compose organs -- all "parts" of one whole human multi-cellular organism. But since the "restriction" clause above uses only the plural form of the word "cell", and since the immediate product of cloning is a single-cell human being, then the following kinds of human cloning would not be restricted by this clause: pronuclei transfer, mitochondria transfer, nuclear transfer (both somatic and germ line cell), parthenogenesis, DNA-recombinant gene transfer, etc. -- in order to produce human/non-human chimeras (including transgenic animals), human/human chimeras, and "designer babies".61 One should also be aware that such human genetic engineering and human cloning -- under the rubric of "IVF research" -- is already being performed legally in the U.S. and elsewhere using both public and private facilities (including IVF clinics), using both public and private funds -- with no laws, regulations, or even guidelines. "Fetal tissue transplant research" is also legal in the U.S., which considers totipotent and/or diploid germ line cells to be classified as "fetal tissue" research rather than human embryo research, and allows these cells to be used in both human cloning and human genetic engineering research.62


A. Unenforceable due to vagueness

Such planned legislative chaos is often the result of the manipulation of at least two intertwining issues -- legal and scientific. Legally, if something is not specifically identified in a law or regulation, that thing is not covered -- and thus is allowed. This legal principle can be put to researchers' advantage in several ways, e.g.: (1) by leaving out specific scientific activities or products in a law or regulation; (2) by misdefining specific scientific activities or products so that the real activity or product is not covered; (3) by slipping them into the "restriction" or "prohibition" sections; and, (4) having contradicting definitions used in different parts of the bill. The hope is that later violations will most probably be dismissed by a court due to "vagueness".

Such legislative "vagueness" was recently addressed during testimony before President Bush's Bioethics Council. Responding to a question concerning recently overturned state laws on human cloning using the constitutional argument based on vagueness, long time bioethics lawyer Lori Andrews nervously responded:

"They are exactly the same language that was struck down as exists currently in the nine states that banned embryo research, you know, because they basically ... talk about it in those terms — embryo or fetal experimentation. ... And where it has been challenged they were — it was struck down as too vague. I think if you described more what process you choose to ban, as some of the states do with the reproductive cloning bans, one of the problems with that, though, is you sometimes get too narrow, that people can invent around it. You know, so like the statutes that say, oh, you can't put, you know, somatic nuclear material into a human egg, then if someone comes along and puts it into another mammalian egg, it — the law doesn't apply."63 (emphases added)

This is precisely what British writer Sarah Sexton (supra) was addressing in the British laws. This intertwining of both the scientific and the legal issues -- and how they can be purposefully manipulated to create legislative loopholes -- urgently needs to be fully and publicly addressed and dealt with.

B. Legislative loopholes become stare decisis

Not only can this manipulation of science and law result in legislative loopholes, it can also result in the perpetuation of those loopholes in future related legal cases. For political -- or other -- purposes, most documents on these issues to date have knowingly incorporated erroneous scientific definitions, often for "political" purposes. Such scientifically erroneous definitions have then become law -- i.e., legal precedence, or stare decisis. Thus bad science has become bad law, which has been dutifully applied from then on. Worse, since law is a "teacher", such scientific and legislative mis-information gradually becomes the social and academic "norm" -- so much so that some scientists have expressed deep concern that it could destroy the scientific field of human embryology itself.64 Other experts in human embryology have maintained a strange silence. If human embryologists are unwilling to defend the integrity of their own field, who will?



What is the state of the issue here in the United States? What U.S. federal regulations, laws, guidelines or other mechanisms are currently in place to prevent grossly unethical research such as human cloning, human genetic engineering, and human embryonic stem cell research (derived from cloned or genetically engineered human embryos) -- for both therapeutic and for reproductive purposes? What federal mechanisms are in place to legally restrict and regulate the burgeoning bio-engineering industry, to protect patients undergoing infertility "treatments" that include asexual reproductive techniques, or to protect sick patients with difficult diseases who participate in transplant "therapies" using such bioengineered human "products"? Given the massive extent of the use of erroneous scientific terms, how can anyone involved give truly legally valid informed consent? How would violations of even any currently available mechanisms be adjudicated? Has such unethical research already slipped past our federal noses, despite all the claims and protests to the contrary? Who or what is in charge?

Even a brief analysis of those documents most often referred to by those most involved in and familiar with these issues might yield the answers to such pressing questions. Consider the following analyses, and then judge for yourself. I would encourage people to go on-line themselves and view these formal documents in full, and in context (see endnotes for URLs). Any corrections or suggestions would be greatly appreciated by this writer -- especially the provisions of any valid documents that do fully, equally, and without ambiguity protect asexually reproduced human beings in destructive research, patients with disabling diseases, and women undergoing fertility treatments.

A. Federal OHRP Regulations [45 CFR part 46]

One of the documents which is often cited and incorporated as authority into various other documents addressed below is that which comprises the federal OHRP regulations (Office of Human Research Protection). Therefore, it is important to look at these OHRP federal regulations for the relevant scientific definitions used there, as those definitions would also automatically apply as authority to any federal (and many state) documents adhering to the Common Rule.

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.65

Those original 1981 OPRR federal regulations used at least two very odd formal scientific definitions (of "fetus", and of "pregnancy") -- which definitions have remained in these current federal regulations (now called OHRP) to this day, despite several subsequent revisions since 1981.66 The point is that these two problematic scientific definitions would be applied in other documents which cite as authority the current federal regulations, and which are mandated to be used by controversial Institutional Review Boards (IRB's),67 many Hospital Ethics Committees (HEC's), and other similar bodies. Would these federal regulations apply to any asexually reproduced human embryos?

Consider the following two erroneous formal scientific definitions still used in these current OHRP federal regulations (in Subpart B):68

§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.

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