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


CONCLUSION:

Upon careful inspection, the Dickey Amendment does not apply to the use of human embryos asexually reproduced, or to stem cells derived from cloned or genetically engineered human embryos. It also does not apply to the use of any human embryos for "reproductive" purposes -- whether sexually or asexually reproduced. Given the recent false distinction in the cloning debates between "research" and "reproductive" purposes, the Dickey Amendment could be construed in the cloning debates as allowing the cloning of human embryos for "reproductive" purposes". And if, as with Weissman et al, human cloning is not cloning if it is for "research" purposes, then the Dickey Amendment could even be construed to allow human cloning for "research" purposes.

The appeal to the authority of the OHRP federal regulations would guarantee that no human embryos, whether sexually or asexually reproduced, whether in vivo or in vitro, through 8 weeks of development, would be protected by the Dickey Amendment; nor are any of these human beings included in the OHRP's definition of "human subject". Because the Dickey Amendment provides no formal definition of "human embryo" and when it begins to exist, it could be rejected in the courts due to vagueness. The appeal to the NIH Revitalization Act for authority would mean that only sexually reproduced dead human embryos, fetuses and cells could possibly be covered by the Dickey Amendment.

The Dickey Amendment has no formal definition of "cloning". If the definition used in current Congressional cloning "bans" is used, "cloning" would be defined only in terms of the SCNT technique, that technique itself would be misdefined, and the cloning of human embryos using "molecules of DNA" (etc.) would likewise not be prohibited. If the definition is used from the Stearns "ban", the product of cloning would just be a "cell" (an oocyte), rather than a single-cell living human organism -- thus protecting no "products" of human cloning techdniques. Likewise, the definitions of terms such as "gametes", or "diploid cells" could also defer to those used in the Congressional cloning "bans", thus allowing much human cloning and human genetic engineering. Thus the Dickey Amendment can not apply to the protection of "cloned human embryos".

The Dickey Amendment would actually allow the use of living human embryos and fetuses sexually reproduced in purely experimental research under certain dubious circumstances and if the Secretary of DHHS says so.

NOTE: What we are clearly beginning to see emerge here is the massive contradictions accruing among several major federal research documents interwoven as "authorities" over the years, using erroneous (or no) scientific definitions for "political" purposes now concretized as stare decisis, ultimately rendering them unconstitutional due to vagueness, and impotent in protecting the lives of both sexually and asexually reproduced human beings in research and in reproduction. Such chaos will take on new meaning with human genetic engineering already firmly on track.

D. OHRP Guidelines on Human Embryonic Stem Cells, Germ Cells, and Products

In March 2002, OHRP issued Guidance for the use of human embryonic stem cells, germ cells, and stem cell-derived test articles in "human subject research". This document would seem to directly address the use of cells and tissues derived from living human embryos and fetuses reproduced sexually or asexually in research. But once again, because of its reliance on earlier problematic federal documents and their definitions (or lack thereof), this federal Guidance does not really protect human embryos or fetuses as "human subjects" in such research:

Scope: This document describes when research activities involving human embryonic stem cells (hESCs), human embryonic germ cells derived from fetal tissue, or hESC- or germ cell-derived test articles are considered human subjects research and what regulatory controls apply to that research. ... Under HHS [OHRP federal] regulations at 45 CFR Part 46, human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.81 (emphases added)

COMMENTS:

1. The definition of "human subject research" is the focus of these Guidances, and references are given to both the current OHRP federal regulations (45 CFR 46) and to Public Law 103-43 (the NIH Revitalization Act). Obviously, the OHPR federal regulations do not include any human embryos sexually reproduced (from fertilization/cloning through 8 weeks of development) in the definition of a "human subject". Neither the OHRP regulations nor the NIH Revitalization Act apply to human embryos asexually reproduced (through 8 weeks) or any fetuses that are asexually reproduced as "human subjects". The NIH Revitalization Act applies only to cells and tissues derived from "dead" human embryos and fetuses sexually reproduced -- not to those derived from living human embryos and fetuses sexually reproduced. Thus this Guidance cannot refer to any of these human embryos or human fetuses as "human subjects". The fact that human embryos -- whether sexually or asexually reproduced -- are killed in the process of obtaining their "stem cells" is ignored.

Another relevant passage refers to the use of human germ cells:

Research involving the derivation and use of human embryonic germ cells from fetal tissue may be conducted with Federal support. ... Research on existing human embryonic stem cell lines may be conducted with Federal support if the cell lines meet the U.S. President's criteria which he announced on August 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html).82 (emphases added)

2. The same problem exists with this section of these Guidances as with the NIH Revitalization Act and "fetal tissue" research. There is no such thing as "fetuses" containing "embryonic" cells! Fetuses contain fetal cells; embryos contain embryonic cells. Such duplicity, or blurring of the scientific definitions of "embryo" and "fetus", allows researchers to do human embryo research (which is illegal) by just calling it "fetal" tissue research (which is legal) -- including the use of these embryonic "germ cells" in human cloning and human genetic engineering research.

3. Again, the OHRP federal regulations referred to do not cover the protection of any embryos (from fertilization through 8 weeks) -- sexually or asexually reproduced -- as "human subjects". Nor do they cover cells or tissues derived from any embryos or fetuses asexually reproduced. So their use in any research is a free-for-all. The NIH Revitalization Act defines "fetal tissue" only in terms of the use of "dead" embryos and fetuses, thus presumably these Guidances could also apply only to the use of dead embryos and fetuses; they could not apply to the use of living human embryos and fetuses.

Note again here the oxymoron "embryonic" cells from "fetal" tissue. The "fetal period" doesn't begin until the beginning of 9 weeks of development! Germ cells ARE "embryonic cells" -- at least those derived from embryos (dead or alive) as early as 2 weeks post fertilization (or cloning) through the end of 8 weeks. Thus the NIH Revitalization Act would not apply to the use of germ cells derived from living human embryos and fetuses -- either sexually or asexually reproduced, thus presumably neither would these Guidances. One question remains: are these embryonic cells (embryonic germ line cells) also subject to President Bush's criteria on the use of human "embryonic" stem cells as well? I think not (see analysis below).

Human germ cells are of particular import, since these are the cells that are uniquely involved with human sexual reproduction -- of a particular individual, as well as of that individual's future progeny. Genetic changes in human progeny by means of genetic engineering can be artificially affected in many ways by manipulating human germ cells, e.g., DNA-recombinant germ line gene transfer, and by genetically altering sperm and/or oocytes before fertilization or cloning. Mature and immature germ cells are diploid, and thus they can be used in cloning (asexual reproduction) using the nuclear transfer technique. Early primitive germ cells are diploid too, but they are also totipotent -- and thus can also be cloned by twinning (asexual reproduction). Apparently none of this research is covered by this Guidance.

As expected, IVF human embryo research and research using transgenic animals are specifically "exempted" from this Guidance, and thus are not covered as "human subject research". IRB review is not even required:

HHS-conducted or supported research that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research. Accordingly, in vitro research and research in animals using already derived and established human cell lines, from which the identity of the donor(s) cannot readily be ascertained by the investigator, are not considered human subject research and are not governed by the HHS or FDA human subject protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56. IRB review is not required for such research.83 (emphases added)

Unfortunately, most human asexual reproduction has and will continue to take place in IVF labs and clinics which are totally unregulated. "Transgenic animals" referred to are experimental animals containing human cells and tissues -- otherwise known as human/non-human chimeras -- reproduced via various sexual and/or asexual reproductive techniques. Again, the source of the "human cells" used seems irrelevant.

4. As is already well-established, the [DHHS] OHRP federal regulations (45 CFR 46) referred to do not cover any human embryos, sexually or asexually reproduced, from fertilization through 8 weeks. Thus it is no surprise that these human beings do not fall under the definition of "human subjects" in these Guidances. Further, with no requirement for any IRB review or approval of IVF or transgenic research, who knows what is really going on in these research labs?

This Guidance also identifies various different federal and state authorities that are empowered to regulate various kinds of research involving the use of human embryonic stem cells, germ cells, and stem cell-derived test articles:

APPLICABLE REGULATIONS AND LAWS
• Research involving these cells or test articles that is conducted or supported by the Department of Health and Human Services (HHS) or performed at an institution that has agreed under an OHRP-approved assurance to apply HHS regulations to all of its human subjects research may be subject to HHS human subjects protection regulations (Title 45 CFR Part 46, including Subpart B, 45 CFR 46.206) .. .84 (emphases added)

5. But what about any such research that is conducted by federal departments other than DHHS, or those that have not voluntarily agreed to comply with the OHRP-approved assurances? Such research would obviously not be subject to these Guidances.

6. Research involving the use of human embryonic stem cells, germ cells, and stem cell-derived test articles that is conducted or supported by DHHS would be guided by the OHRP federal regulations. And those regulations do not include in the definition of "human subject" any human embryos, sexually or asexually reproduced, from fertilization through 8 weeks. Therefore, this Guidance itself cannot. The same would apply to any research conducted or supported by any other federal departments or agencies that have voluntarily signed on to the Common Rule.

Of special import to patients ("human subjects") who will take part in clinical trials that involve the use of these human embryonic stem cells, germ cells, and stem cell-derived test articles, the following additional authorities also apply:

• All clinical research involving drugs, devices, and biological products regulated by FDA, including cells or test articles regulated as drugs, devices, and biological products, is also subject to FDA regulations governing investigational new drugs (INDs) or devices (IDEs) (Title 21 CFR Parts 312 or 812), regardless of the source of support. This clinical research is also subject to FDA's IRB and informed consent regulations (Title 21 CFR Parts 50 and 56).

• In addition, clinical research involving the transplantation of cells or test articles derived from human fetal tissue into human recipients is subject to Public Law 103-43, "Research on Transplantation of Fetal Tissue" (42 U.S.C. § 289g-2(a)). [NIH Revitalization Act]

• Other Federal, State or local laws may also apply to transplantation or other research involving these cells or test articles.85 (emphases added)

7. Thus if patients ("human subjects") are participating in a clinical trial involving these cells when they are considered as "drugs, devices, and biological products", the FDA regulations apply.86 But these FDA regulations are vague as to whether or not the use of human embryos or fetuses -- or their cells, tissues or other constituent parts -- can be derived from asexually reproduced human embryos and fetuses (human beings), or just from sexually reproduced ones. Given the current preference of researchers to clone cells from diseased patients -- thus asexually reproducing a diseased cloned human embryo from whom its "stem cells" will be removed and used -- , or given the possibility of using artificially produced and genetically engineered human cells, such ambiguities should be of concern, especially to the patients into whom such cells will be injected. One of the most important factors the FDA and other similar regulations considers is the risk to patients into whom such "products" are injected or transplanted, and it is reasonable to consider that such "products" from either sexually or asexually reproduced "sources" would put human patients into whom they are injected at considerable risk. Yet one of the most contentious definitions since the institutionalization of the OPRR/OHRP federal regulations, and all related regulations, has been an agreed upon definition of "risk", thus calling into question just how protected these "human subjects" really are in such research.

8. If patients are involved in clinical trials involving the transplantation of such cells, the NIH Revitalization Act also applies. But that Act applies only to the use of cells and tissues derived from dead human embryos and fetuses (thus contradicting the Dickey Amendment), and does not apply to any such cells or tissues derived from asexually reproduced embryos or fetuses. Thus its authority in these Guidances is negated.

9. These OHRP Guidelines apply to the use of federal funds only. The use of private funds for such research -- except when the authority of the FDA is invoked -- is not affected.

CONCLUSION:

The purpose of these Guidances is to clarify the use of human cells and tissues, etc., in "human subject research". Obviously, for reasons already discussed previously, no human embryos or fetuses -- whether sexually or asexually reproduced -- can be considered "human subjects". In all contexts they are merely "products". But what about the use of cells and tissues derived from them in the context of "human subject research"? Would not the erroneous, confusing, and sometimes contradictory definitions of such critical terms as "human embryo", "human fetus", "human organism", "human germ line cells", "living" or "dead", etc., in the authorities identified in these Guidances negate the use of cells and tissues derived from such human embryos and fetuses -- or at least be contested due to vagueness? For example, how can there be "guidances" about the use of "human embryonic stem cells" or "fetal tissues" when there are no formal definitions in the authorities cited for the sources of those cells and tissues, or where definitions used are scientifically erroneous?

Thus, how well are "human subjects" participating in the research described in these Guidances really protected? The question becomes more acute with respect to human patients participating in "IVF research", since this as well as "transgenic research" are specifically exempted from these Guidances. "IVF research" can provide cells and tissues from both sexually and asexually derived human embryos and fetuses, but their use in human patients would not be prohibited by these Guidances. Similarly, "transgenic research" can also produce cells and tissues for use in human patients, but such research would also not be prohibited by these Guidances. There are also no protections for human patients if participating in research or clinical trials where genetically engineered human or animal cells and tissues are used.

E. Federal Policy on Human Embryonic Stem Cell Research

On August 9, 2001, President Bush gave certain criteria that must be met before any federal funds could be used involving "human embryonic stem cells" in research:87

Federal funds will only be used for research on existing stem cell lines that were derived: (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. In order to ensure that federal funds are used to support only stem cell research that is scientifically sound, legal, and ethical, the NIH will examine the derivation of all existing stem cell lines and create a registry of those lines that satisfy this criteria. More than 60 existing stem cell lines from genetically diverse populations around the world are expected to be available for federally-funded research. ... No federal funds will be used for: (1) the derivation or use of stem cell lines derived from newly destroyed embryos; (2) the creation of any human embryos for research purposes; or (3) the cloning of human embryos for any purpose.

COMMENTS:

1. The fact that "human embryonic stem cells" are derived by killing already existing human embryos -- who are scientifically demonstrated to be living human beings -- is ignored.

2. Funds can be used for research on existing stem cell lines that were derived from excess embryos created solely for "reproductive purposes". The assumption is that such embryos were reproduced sexually using IVF. However, if pressures succeed in allowing stem cell lines to be newly created, and if the phrase "for reproductive purposes" is still maintained, then this phrase could be interpreted by researchers like Weissman, West et al to include human embryonic stem cells derived by means of human cloning for "reproductive purposes", thus sanctioning human cloning.

3. No one can possibly give ethically or legally valid "informed consent" when they are "informed" that these living human embryos -- from whom such human embryonic stem cells are derived -- are just "pre-embryos" or just "cells" or "balls of cells" (thereby excluding the fact that they are living human organisms, human beings). Nor can such research be considered "scientifically sound" when the erroneous scientific terms used do not match the reality of what is actually being done in such research. Nor can such research be considered "ethical" -- unless by "ethical" one means "bioethical" -- aka "federal ethics".

4. There is no formal definition of "embryo" in this policy, or when an embryo begins to exist -- either sexually or asexually reproduced, in vivo or in vitro. So what other federal documents could be cited as authority for such a critical definition?

None of the documents already examined apply to embryos that are asexually reproduced, including the Dickey Amendment (which has no formal definition of "cloning"). Further, the OPHR federal regulations have no definition of either sexually or asexually reproduced human embryos before implantation, and in fact define away the embryo from implantation through 8 weeks of development (in vitro and in vivo). The NIH Revitalization Act applies only to the use of already dead embryos, not to living embryos that will be killed in order to derive their "stem cells" -- contradicting the Dickey Amendment. The Dickey Amendment applies only to the use of human embryos created for "research" purposes, contradicting the above policy which specifically prohibits the use of federal funds for creating human embryos for research purposes. The OHRP Guidelines on the use of stem cells, etc., conflate "embryonic" and "fetal" cells, leaving not only human embryos but also human fetuses at risk of exploitation for the derivation and use of their "stem cells" for new "stem cell" lines, including germ line cells that could be derived from asexually reproduced human embryos and fetuses. Those guidelines also do not cover the use of any human embryos or human fetuses involved in either IVF or transgenic research, or the use of any cells derived from them when injected into patients.

Thus the lack of any scientifically accurate definition of "embryo" in the above policy, or any other federal laws or regulations, could render it unenforceable due to vagueness.

5. This policy as stated makes no distinction between human embryonic stem cells derived from sexually reproduced human embryos, and those derived from asexually reproduced human embryos. As noted, the pressure is on now to allow the use of newly created human embryos from which to derive new stem cell lines. If a new policy failed to make the necessary distinction noted, then the door would be left open for including human embryonic stem cells derived from cloned human embryos.

6. This policy prohibits the use of federal funds for "the cloning of human embryos for any purpose". Yet there is no formal definition of "cloning" in this policy, or in any of the documents already examined. If the definition of "cloning" is that used in the Congressional cloning bills supported by this administration, where "cloning" is defined only in terms of the misdefined SCNT method only, then this policy would not cover any methods of cloning to asexually reproduce new cloned human embryos from whom "human embryonic stem cells" would be derived.

7. No federal funds will be used for "the creation of any human embryos for research purposes". But if a new policy were to be created to allow human embryonic stem cell lines from newly created human embryos, the phrase "research purposes" could be interpreted by researchers like Weissman et al to mean just "stem cell research" and not "cloning" -- thus in reality allowing federal funds to be used for cloning human embryos in order to derive their stem cells for "research purposes".

8. The role of the NIH to "examine" the derivation of all existing stem cell lines is worrisome, insofar as NIH has a long history of involvement with the "pre-embryo", its various "substitutes", the OPRR / OHRP federal guidelines, and other manufactured "science".88 Indeed, in his 1998 Congressional testimony then-NIH Director Harold Varmus defined the immediate product of fertilization as just "totipotent stem cells" (no human being or human organism there!). The developing "entity" after fertilization is likewise just "a ball of cells", and there is no human being ever present until and unless the "cells" are implanted and develop to adulthood!89 This is strange "science" indeed, coming from a prestigious institution such as NIH. It is also strangely similar to the "fairy tale" science that those like Weissman and West are currently using as the basis for a number of bills and reports concerning "stem cell research".90 Weissman, like Varmus, defines away the human being immediately reproduced sexually by fertilization, and asexually by nuclear transplantation; indeed, Weissman defines away "therapeutic cloning" itself using the same fairy tale science. Thus what Weissman includes in his definition of "stem cell research" are "stem cells" derived from cloned human beings. The NIH's Guidelines for Stem Cell Research and its Report91 likewise contain similar scientific "irregularities", and the conflict of interests between NIH and the drug industry has also received much negative scrutiny lately. Thus on the basis of what "science" and credibility is NIH to examine anything involving any of these related stem cell research issues?

9. The President's policy on human embryonic stem cell research applies to the use of federal funds only. The use of private funds for such research is not affected.

CONCLUSION:

This federal policy on human embryonic stem cell research has no formal definitions of "embryo" or of "cloning", nor does it make the critical distinction between human embryonic stem cells derived from sexually or asexually reproduced human embryos. If pressures succeed in allowing the expansion of the number of human embryonic stem cell lines, the use of phrases like "for research purposes" and "for reproductive purposes" in the current policy could be exploited, thus sanctioning the derivation of human embryonic stem cells from cloned and other genetically engineered human embryos. Indeed, the increasing use of "distinctions" between "research" purposes and "reproductive" purposes could cause havoc in any future legislation, regulations or policies.

Because of the demonstrated lack of scientific integrity of NIH on previous issues involving human embryo research and human embryonic stem cell research, their "examinations" would surely lack credibility.

As currently written, this policy could not cover the use of asexually reproduced human embryos and the derivation or use of their "stem cells".

F. New Law on "Child Health Insurance Programs":

In October 2002, the SCHIP Program was amended to include, among other things, prenatal health care to pregnant women. Note the formal definition of "child" used:

Subpart A--Introduction; State Plans for Child Health Insurance Programs and Outreach Strategies
2. In Sec. 457.10, the definition of "child" is revised to read as follows:
Sec. 457.10 Definitions and use of terms.
Child means an individual under the age of 19 including the period from conception to birth.93 (emphases added)

COMMENTS:

1. Because of the formal definition of "child" used, this new law obviously applies only to human embryos and fetuses sexually reproduced. Thus it could not apply to the protection of any human embryos or fetuses asexually reproduced, even if implanted.

2. The law applies only in the context of a pregnant woman seeking health care for her unborn child. Therefore it would not cover in vitro human embryos reproduced in vitro either sexually or asexually.

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