"U.S.A. -- Human Cloning As Source of 'Non-Federally Approved' Human Embryonic 'Stem Cell Lines'"

Dianne N. Irving
Copyright October 10, 2004
Reproduced with Permission


Now that so much false science has been concretized in many state1 and federal laws and regulations,2 as well as in "reports" by such prestigious "advisory bodies" as the National Academy of Sciences,3 we now have included in the definition of "stem cells" those derived from cloned human embryos. Regardless of their source, all stem cells are now simply lumped together under the protective umbrella of "stem cell research".

This has been quite easily accomplished by researchers such as Irving Weissman4 and Michael West5 by (amazingly and easily) convincing people of their "fairy tale science".6 That is, they claim that the immediate product of fertilization or cloning (e.g., one form of cloning called somatic cell nuclear transfer, or SCNT) -- is just a human "cell" - a "stem cell" to be exact -- rather than the accurate scientific fact that it is a new genetically unique individual living single-cell human organism7 - a human being, a human zygote. Similarly, they claim that the human blastocyst is an "embryo" but define it as "just a ball of cells", rather than as a multi-cellular organism. Most amazingly, they claim that nuclear transplantation is not cloning any more if the purpose is for "research", but is cloning if the purpose is for "reproduction" (and not just if the purpose is implantation, but only if the purpose is for the "entity" to be "born"). Hence, what they are doing is "stem cell research", not cloning!

Such "fairy tale science" flies in the face of internationally acknowledged scientific facts,8 and even admitted to by many pro-cloning researchers themselves.9 But the "draw" is too strong for some, and so now we as a society must face the dark consequences: real live human cloning is being slipped through the radar using the brave new rhetoric of "stem cell research".


The current federal policy for the use of federal funds for stem cell research - at least for now - prohibits the use of federal funds for the cloning of human beings. But, as pointed out elsewhere, private funds (from anywhere, including from overseas) can still be used to cloning human beings.

Yet rather than be up-front with what is involved, these private organizations would rather hide behind the handy new rhetoric of "stem cell research". That is, they will claim that what they are doing is just "stem cell research", without acknowledging that the source of those human embryonic stem cells is living human beings who have been cloned in vitro, allowed to develop to the blastocyst stage, and then killed in order to derive their "stem cells".

A current example is implied in the following "Memorandum" from PARTNERS Health Care Human Research Committee to its research "investigators":

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

Ostensibly, the project is about "human embryonic stem cell research" -- using "non-federally approved" human embryonic stem cell lines, i.e., those that have been privately created since President Bush's pronouncement that only already-existing human embryonic stem cell lines could be used in research using federal funds (such as those at Harvard University, with which PARTNERS is affiliated). We're just talking "stem cell research" here - right?

Yet as the "Memorandum" above indicates, one may "derive hESC via somatic cell nuclear transfer" - aka, human cloning by means of the somatic cell nuclear transfer cloning technique. What is missing here is the acknowledgement that human cloning is essentially and fundamentally involved in this "stem cell research". And one wonders where such human cloning is taking place, by whom, and whose private funds are being used?

[The full "Memorandum" and further information on PARTNERS Health Care, is copied in full below.]


Note the reference in the "Memorandum" above to the need for "IRB approval". The highly controversial IRB system11 was specifically set up with the original OPRR12 (now OHRP)13 federal regulations concerning the use of human subjects in research, and IRB's must follow these federal regulations.

A. Federal OHRP Regulations

However, these federal regulations have no formal definition for a "human embryo", and can be applied only to "fetuses" that have been sexually reproduced (fertilization), not to those that have been reproduced asexually by cloning. They also erroneously define both "fetus" and "pregnancy" as beginning at implantation. Both definitions are scientifically absurd. Since in the real world the embryonic period is from fertilization/cloning through 8 weeks of development, these federal regulations would not apply to any human embryos - whether they have been reproduced sexually (fertilization) or asexually (as in cloning), in vitro or in vivo, through 8 weeks of development. It is no wonder then that living human embryos, human beings - cloned or otherwise -- are not considered as "human subjects" in research. Rather, they are "objects". Thus the "assurances" sought by PARTNERS would not even acknowledge human embryos as "research subjects" at any stage of human embryonic development, much less if they were cloned.

B. Administration's Policy on Human Embryonic Stem Cell Research

Perhaps the 2001 administration's policy on the use of human embryonic stem cells in research could apply to these "stem cells" derived from cloned human embryos.14 Yet this policy has no formal definitions of "embryo" or of "cloning" (nor does any other federal law or regulation), nor does it make the critical distinction between human embryonic stem cells derived from sexually and those derived from asexually reproduced human embryos.

And 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 administration's policy could be exploited and redefined by researchers such as Weissman and West, thus surreptitiously sanctioning the derivation of human embryonic stem cells from cloned and other genetically engineered human embryos. Indeed, this increasing use of the false "distinctions" between "research" purposes and "reproductive" purposes could cause havoc in any future legislation, regulations or policies. As currently written, this administration's policy could not cover the use of asexually reproduced human embryos and the derivation or use of their "stem cells" such as those identified in the PARTNERS "Memorandum".

C. OHRP Guidances

But what is supposedly applicable are the current OHRP federal Guidances for stem cell research,15 developed after this administration's policy on the use of federal funds for human embryonic stem cell research was announced.

Yet even these OHRP federal Guidances contain serious problems. Again, they can not be applied to any human embryos - cloned or otherwise -- because of the authority of the definitions in the OHRP federal regulations appealed to. Furthermore, 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 other authorities identified in these Guidances negate the use of cells and tissues derived from such human embryos and fetuses --or at least can be contested in the courts 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 any of the authorities cited for the sources of those cells and tissues, or where such definitions used are scientifically erroneous?

Thus, one wonders just how well "human subjects" that will eventually be participating in "therapeutic research" clinical trials based on the research described in these Guidances are really protected? Because of the "slippery" scientific language used, there is no way that such patients could possibly give ethically or legally valid informed consent.

Furthermore, 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, and their use in human patients would not be prohibited or regulated by these Guidances. Similarly, "transgenic research" can also produce cells and tissues for use in human patients, and such research would also not be prohibited or regulated 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.

We are reaping 40 years of political compromises on these related issues - from both sides of the aisles. The politicization of science is accomplished. And no one even knows it.


The full PARTNERS "Memorandum" is copied below, as well as related URL's:



To: Investigators involved with or planning to be involved with hESC research

From: Pearl O'Rourke, MD, Director, Human Research Affairs

Date: June 23, 2004 Re: Requirements for Investigators Conducting, or Considering, Human Embryonic Stem Cell (hESC)

Research at MGH, BWH and McLean Research involving hESCs is clearly an area of promise and interest to both local and national investigators. hESC research has also generated a remarkable amount of publicity with very vocal proponents and opponents. This public attention in concert with applicable federal regulations and Massachusetts state law mandates meticulous local oversight and accountability. Policies and procedures for hESC research conducted at Partners are being developed with specific attention regarding procedures for any work with the so-called non-federally approved hESC lines. We are working with others in the Harvard system and are in dialogue with relevant federal agencies and hope to have guidance available within the next 4-6 weeks.

In the interim, we would like to ascertain that any ongoing hESC research is in compliance with federal and state regulations. To that end, if you are conducting or planning any aspect of hESC research, please contact Pearl O'Rourke at porourke@partners.org.

Until detailed institutional guidance for hESC research is available, the following facts may be helpful:

*If you are using federally approved hESC lines (listed on the NIH Stem Cell Registry: http://stemcells.nih.gov/research/registry/)

*If you are working with non-federally approved hESC lines (any hESC not listed on the NIH Registry - for example, hESC from Harvard that were derived with private funds)

*If you are working with existing hESC - when must you go to the IRB?

*If you wish/plan to derive hESC from existing embryos:

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

*If you are plan to provide embryos to another investigator for the purpose of deriving hESCs:

*You should contact the Office of General Counsel to determine compliance with the Massachusetts state law. Please forward these questions to Susan Stayn at sstayn@partners.org.


PARTNERS Health Care

Partners HealthCare, based in Boston, Massachusetts, is an integrated health care delivery system founded by Massachusetts General Hospital and Brigham and Women's Hospital. Partners includes its founding academic medical centers, primary care and specialty physicians, community and specialty hospitals, health centers and home care. In addition, Partners is one of the nation's premier biomedical research organizations and is a major teaching affiliate of Harvard Medical School. Partners is a non-profit organization supported in part by charitable contributions.


PARTNERS Health Care System
PARTNERS Human Research Committee
Main Office: 10 Brookline Place, West
MGH Satellite Office: Laurence House, Third Floor

Updates from the Human Research Protection Program


The MGH and BWH human research protection programs are in the process of seeking accreditation from AAHRPP (Association for the Accreditation of Human Research Protection Programs, Inc.). For a description of AAHRPP and the process of accreditation - please refer to the June 16, 2004 letter.

The written application has been submitted. The site visit is scheduled for Tuesday through Friday, October 5-7, 2004. During the site visit, AAHRPP evaluators will meet with investigators, whom they will randomly select, to ask about the investigators' role in protecting human subjects. The site visitors will also go to a few research laboratories/offices to examine among other things, the organization of your research files and security measures to assure confidentiality. As part of our preparation for the site visit, we will be sending you frequent, brief educational bullets as a reminder of specific policies - please take a moment to read these. This is also an excellent opportunity to consult with the Partners Human Research Quality Improvement Program to assess your compliance with relevant regulations and policies.

If you have any questions about accreditation - please contact P. Pearl O'Rourke, MD porourke@partners.org or Rosalyn Gray rgray1@partners.org.


1 See, e.g., California State human cloning bill, at: http://info.sen.ca.gov/pub/01-02/bill/sen/sb_1201-1250/sb_1230_cfa_20020826_122024_sen_floor.html; California State stem cell resarch bill, at: http://info.sen.ca.gov/pub/01-02/bill/sen/sb_0251-0300/sb_253_cfa_20020829_175107_sen_floor.html. [Back]

2 For scientifically erroneous definitions used throughout most federal laws and regulations, see Irving, "What is 'bioethics'?", in Joseph W. Koterski (ed.), Life and Learning X: Proceedings of the Tenth University Faculty For Life Conference 2000 (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; also Irving, "Analysis of Legislative and Regulatory Chaos in the U.S.: Asexual Human Reproduction and Genetic Engineering" (Oct. 8, 2004) (in press). [Back]

3 As noted by the National Academy of Sciences Report (chaired by Irving Weissman): "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." [Stem Cells and the Future of Regenerative Medicine (2002) Commission on Life Sciences, at: http://www.nap.edu/books/0309076307/html. [Back]

4  For example, Weissman states: "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." [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://news-service.stanford.edu/news/2003/january22/message.html. Also,

"Technically, one should not use the term embryo to describe a blastocyst produced by nuclear transfer as an embryo, because it was not the product of sperm and egg, although I think that since the embryologists who coined the term embryo could not have known about nuclear transfer technology, it's anyone's guess what they might say now. ... 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." [ibid]. Again, "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." ["Report of the California Advisory Committee on Human Cloning" (Jan. 11, 2002), Sacramento, CA, at: http://scbe.stanford.edu/conference/cloning_cali.pdf.] [Back]

5 "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 ... ." ["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.] [Back]

6 Quoting from article by Rick Weiss, "To start with, people need a fairy tale," said Ronald D.G. McKay, a stem cell researcher at the National Institute of Neurological Disorders and Stroke. "Maybe that's unfair, but they need a story line that's relatively simple to understand." In 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. [Back]

7 For scientific references distinguishing a "cell" from an "organism" - and specifically the human organism - see Irving, "Definitions of a 'Human Organism' and a 'Human Cell'" (October 3, 2004), at: http://www.lifeissues.net/writers/irv/irv_78definitions.html. [Back]

8 See, e.g., Tom Strachan and Andrew P. Read, Human Molecular Genetics 2 (New York: John Wiley & Sons, Inc, 1999): "A form of animal cloning can also occur as a result of artificial manipulation to bring about a type of asexual 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." (pp. 508-509). Of course, a "fertilized oocyte" IS a new genetically unique living single-cell human being, a human organism. For scientific references, see note 7 supra. [Back]

9  See, for example: Jonathan Van Blerkom, human embryologist at University of Colorado, expressing disbelief that some deny that human cloning produces an embryo: "If it's not an embryo, what is it?". Dr. Van Blerkom said researchers' efforts to avoid the word "embryo" in this context are "self-serving.", in American Medical News, Feb. 23, 1998, p. 32.

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, 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. [Back]

10 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. [Back]

11  The malfunctioning 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 [Back]

12 The original OPRR federal regulations for the use of human subjects in research were established by Title 45; Code of Federal Regulations; Part 46 [45 CFR 46]; Office for the Protection from Research Risks [OPRR]; U.S. Department of Health and Human Services, 1981; erroneous definitions of "fetus" and "pregnancy" can be found on p. 12 . Those erroneous definitions, in turn, were derived from the National Research Act, Public Law 93-348, 93rd Congress, 2nd session (July 12, 1974); 88 STAT 342; see also National Commissioner Albert Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), pp. 94-98, 333. [Back]

13 Current OHRP federal regulations can be accessed at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. [Back]

14 White House press release, "Embryonic Stem Cell Research", August 9, 2001, at: http://www.whitehouse.gov/news/releases/2001/08/print/20010809-1.html. [Back]

15 Office for Human Research Protections, Department of Health and Human Services: Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles (March 19, 2002), http://ohrp.osophs.dhhs.gov/humansubjects/guidance/stemcell.pdf. [Back]