NIH and human embryo research: a critical analysis

Dianne N. Irving
Assistant Professor
History of Philosophy/Bioethics
De Sales School of Theology
Washington, D.C. 20017
Copyright December 7, 1994
Edited for clarity and format, July 21, 2004
Reproduced with Permission

[Presented to the Business Roundtable Breakfast sponsored by DeSales School of Theology, at Law Offices of Gardener, Careton and Douglas, Washington, D.C.; December 7, 1994.]

Good morning! I'd like to thank Fr. John Crossin, President of the De Sales School of Theology, and those from the law firm of Gardener, Careton and Douglas, for hosting this breakfast meeting for De Sales. I would also like to thank all of you for being here at such an early hour of the morning - especially to hear about and hopefully discuss, some recent issues which are troubling and confusing to many.

Are there really Frankenstein-like experiments going on? Are there no realistically effective controls on all of this "new reproductive technology"? Will my children or grandchildren end up in some scientist's petri dish? Will I or my children be able to get insurance if we carry a "bad" gene? Could we ever countenance a national policy, such as in China and other third world countries, where families with more than one child must be aborted, or children with the wrong sex or with disabling genes must be eliminated?1

Recently, a couple (who are dwarfs) told their genetic counselor that if their fetus was "normal", they would want to have it aborted, because they preferred a child more like them.2 And consider a recent poll in which close to 30% of the respondents replied that they would abort their child if they knew in advance it would be obese!3 (Somehow I guess I would have made the cut, but I doubt that my husband would have!) Now that we supposedly have identified the gene for obesity, would that mean that we should abort them? Despite the early hour, perhaps some clarity and objectivity can be brought to at least one of these issues, i.e., is human embryo research ethical?

I want to address this morning the recent NIH Recommendations4 on the use of living human embryos for experimental research. Great benefits can be attained, they claim, e.g., the curing of diseases, the treatment of infertility, and the pure advancement of scientific knowledge. Who would be so insensitive as to reject human embryo research, when so much good can be realized? When so many people agree with the "carefully considered and scientifically grounded" Recommendations of the Panel, only ignorant, uneducated, unsophisticated people who linger among the shadows of the irrational "far right" could possibly find them objectionable!

What I discovered was that objections to this research were not coming from irrational, right-wing, ignorant and uneducated bigots. Nor is this issue one of "balancing one group's belief system against another group's belief system". Nor is this really about religion or pro-life zealots or anti-scientific research mentalities. Nor are these NIH recommendations grounded in or based on sound science, guided by sound moral reasoning, or constitutive of sound public policy.

Rather, this is an issue which concerns humanity itself; it is about human rights. And those who have taken a stand against this research come from all religious, non-religious, grass roots, cultural, academic, professional, and political persuasions. There have been over 53,000 letters of protest (including many from overseas), compared with only 1,300 letters of support. Most of this research has already been rejected by every other country, and violates many of our own state laws. The United States would be the first and only country in the world to sanction most of this research.

Furthermore, these NIH recommendations are in fact the product of a small but clever and powerful group of academic and political elites - particularly in the fields of bioethics, the hard sciences and the social sciences - who, after years of unchallenged educational efforts and publications, have crafted and fabricated a working set of "ethical principles" and bogus theories of human nature, and who have really exploited the unfortunate current epidemic of infertility and childlessness, as well as the difficult problems associated with genetic imperfections and diseases, in order to advance their own research agendas.5

My original title for this discussion was "NIH and Human Embryo Research": A Critical Analysis" - but a good sub-title could easily be "What is Wrong With This Picture?"! Many of you have probably registered a bit of uneasiness in response to some of the discussions and reports concerning the NIH's recommendations - quite aside from your individual political affiliations or positions on abortion. My reaction was very much the same, when upon finishing the first part of my analysis for my dissertation6 I sat back and took in the results.

I had originally intended to argue that "personhood" (or the moral status of the early human embryo) began about 14-days - given the 15 years of scientific and philosophical arguments so popular in the academic bioethics literature at the time. I had retrieved the mountains-high stacks of articles and books on the subject, and had selected just 23 "representative" arguments on "delayed personhood" - arranging them in chronological order along the continuum of the biological growth and development of the human being - from fertilization through birth and early childhood. But my focus was on the supposedly gray area between fertilization and 14- days.

I analyzed these arguments according to three criteria (no religion or theology!): scientific accuracy; historical philosophical accuracy and defensibility; and logic. After literally years of verifying these criteria, I reluctantly concluded that in all 23 arguments, the science used was incorrect; the philosophy used was historically inaccurate or embarrassingly indefensible; and that none of the conclusions even followed logically from their major and minor premises. The statistical chances of this happening are, frankly, zero. Half-way through the dissertation, then, I sat back and asked myself - "What is wrong with this picture?"

Turning quickly to how the present situation concerning human embryo research came about, for over 20 years a ban, or moratorium,7 had been placed on the use of federal funds for fetal tissue transplant research and IVF research. One common misconception is that all fetal research and IVF research had been banned. However, the moratorium banned only fetal tissue transplant research, and not all other types of fetal research, which have been going on for years in both private and federally funded labs (including NIH, which has a central retrieval and distribution center in Seattle, Washington, which has supplied live human embryos and human fetuses to researchers for over 30 years Ð as posted on the NIH website.) Also, under the moratorium, IVF research was conditioned on approval by an Ethics Advisory Board. Because this board was never appointed, the moratorium also precluded federally funded IVF research as well. However, human embryo research was not even articulated as part of the restriction on IVF research - another common misconception.

President Clinton, upon his election, lifted the moratorium on fetal tissue transplant research by signing into law the NIH Revitalization Act of 1993.8 It was through this Act, by a very clever move, that IVF research (aka, human embryo research) was - by default - Congressionally sanctioned. As proponent Joseph Palca, writing in the Hastings Center Report, so effusively stated: "With lobbying support from the American Fertility Society, and the willing cooperation of Senator Kennedy and Representative Waxman, they hit on the strategy of simply eliminating the requirement that the EAB approve IVF research projects. Language doing that was slipped into the NIH Revitalization Act of 1993...attracting very little attention".9 (emphasis mine)

Immediately NIH set up their Human Embryo Research Panel, to address the "profound moral and ethical issues" connected with the use of living human embryos in destructive experimental research. After almost 9 months of "public" hearings, the Panel concluded as ethically acceptable much of the proposed research. Human embryos could be acquired by: producing them specifically for research purposes by IVF; using those left over from IVF treatment with the informed consent of the donor (so-called "surplus" human embryos); embryo flushing; parthenogenesis; and production with sperm from anonymous male donors. Ova could be obtained from: the donation of ovaries from female cadavers if they had given previous consent, or if their next of kin agreed (without transfer); women undergoing IVF treatment; and, women (and young female children) undergoing scheduled pelvic surgery.10

Several categories of research were found to be acceptable, including ("but not limited to") studies on: IVF pregnancy rates; contraceptives; parthenogenesis (without transfer); embryonic stem cell cultures (only with "surplus" IVF embryos, without transfer); nuclear transplantation (without transfer); the verification of important scientific data; and, those concerning preimplantation genetic diagnosis (with and without transfer).11

Needing further review ("for now") included: studies using human embryos after 15 days until the closure of the neural tube (about 18 days); cloning (without transfer); the use of oocytes from aborted female fetuses, which are then fertilized and used (without transfer); nuclear transplantation (without transfer); and, the development of stem cells using embryos fertilized specifically for this purpose. Unacceptable ("for now") included: cloning (with transfer); preimplantation genetic diagnosis for sex selection (except for sex-linked diseases); fertilization of fetal oocytes (with transfer); nuclear cloning (with transfer); the use of human embryos after the closing of the neural tube (after 18 days); the formation of human/human and human/non-human chimeras (with or without transfer); cross-species fertilization, except those which have already been used for some time, e.g., those involving chimeras formed with hamster sperm and human ova to test for sperm fertility [no mention of those already used to produce "transgenic mice" or other human/non-human chimeras, e.g., those used in AIDS research]; and the transfer of human embryos for extra uterine or abdominal pregnancies [not mentioned, e.g., male pregnancies; or transfer into gorillas, chimpanzees, etc.]; and, the transfer of human embryos into non-human animals for gestation [no mention of the transfer of non-human embryos into humans for gestation].12

But, as enticing and exciting as all of this sounds, what is wrong with this picture? I want to point out to you in the time remaining just a few considerations.13

1. It is important to understand that research now considered unacceptable or needing further review can be immediately sanctioned by Dr. Varmus at his own discretion including those studies in the unacceptable and needing further review categories, and including that single and limited category which President Clinton just recently wanted banned because of the "profound moral and ethical problems" connected with them (i.e., human embryos produced solely for research using federal funds). Clinton's statement was deceptive, as it would not include human embryos produced solely for research using private funds, or "surplus" human embryos from IVF, etc. Furthermore, legally Dr. Varmus can override any objection, even the President's and Congress', at will.14

2. As the Panel itself admits, the 14-day marker is purely arbitrary. Indeed, several of the panelists insisted that in order to scientifically validate many of these proposed studies, eventually the marker will have to be gradually erased all together so that the researcher can determine the actual success or failure of his interventions.15

3. The legal status of this Panel, and the composition of its membership, have met with strong objections. First, it is alleged that the Panel violates several provisions of the Federal Advisory Committee Act.16 Second, the Panel admits itself that it was purposefully stacked only with members who would approve of this research. Many of the members have participated in similar commissions before, aggressively taking partisan positions17 and even defining per se the "ethical principles" which are to be used a priori in the commissions' considerations.18 For example, several members served on the National Commission which, as recently admitted by one of its members, basically made up the "bioethics principles" later used to base the conclusions and recommendations of the President's Commission, the NIH Fetal Tissue Transplant Conference, the OPRR regulations for the use of human subjects in research, and indeed this present NIH Panel's Recommendations. Many of the members have also been involved publicly for years in national and international abortion, euthanasia, and eugenics organizations and industries.19 And 10 of the 19 members have received over $21 million from NIH from 1989 to the present to conduct research similar to that under their own review. Furthermore, there was not even one human embryologist on the Human Embryo Research Panel at all.

4. Perhaps one can better understand why, if one considers the very basis and grounding of the NIH's Recommendations - i.e., their so-called "balanced" claim that the moral status of the early human embryo is less than that of born children and adults. If NIH cannot sustain and defend that grounding claim about the moral status of the early human embryo, then all of their Recommendations are per se groundless, arbitrary and invalid.

There are several major objections to NIH's claim that the moral status of the early human embryo is less than that of born children and adults:

Why would NIH, supposedly one of the greatest scientific research institutions in the world, with immediate access to almost infinite scientific resources and experts, decide to use only an Australian bioethics book to reference its human embryology chart, its scientific definitions, and several of its other major recommendations? Why was there no human embryologist on this NIH Panel?

Why have many academic scholars, who have tried for years to correct the scientific and philosophical inaccuracies and misconceptions in the popular and academic press been precluded from publishing those corrections?25

Why were bioethics principles fabricated? And if they don't work, as admitted now even by their creators and so many practitioners in the field,26 then why are they still being invoked as the basis for "ethical" evaluations, especially in the formulation of public policy - such as in this NIH Panel's recommendations?

What harm is caused by the application of these inaccurate, indefensible and impractical theories and ideas? And who is accountable for the concrete harm that is caused? It is simply not true that one idea or theory is just as good as another idea or theory. Some match reality, and some do not. Some can be defended, and some cannot. And when applied to millions of innocent people, considerable harm can result.27

Regardless of the great benefits obtainable by creating and then destroying some human beings in order to help other human beings, or to advance scientific knowledge, national and international declarations and precedents have unambiguously stated that the means used to those laudatory ends may not include the harm or death of human subjects. For example, the Nuremberg Code28 states that regardless of goods yielded to society, research using human subjects must conform to certain ethical and legal concepts, primary among which are the use of qualified scientists and correct scientific information, the human subject's informed consent, and a minimal level of personal risk to the subject. The Declaration of Helsinki states: "In research on man, the interests of science and society should never take precedence over considerations related to the well-being of the subject."29 Even the NIH's OPRR regulations ensure that unborn children, whose parents intend to abort them, are equally protected from research harm as those children intended for live birth.30 And where in our Constitution of Bill of Rights is there a guarantee of the rights of some human beings, or even the government, to purposefully create other human beings to be destroyed or donated for "the greater good of society or of science"?

Despite the catastrophe of the Nazi medical experiments with "sub-humans" who were going to die anyway and so they might as well get some good out of them, shadows of that rationale keep emerging, even in our own society, from time to time. Consider the Willowbrook experiments, in which mentally retarded children were purposefully infected with infectious diseases in order to study the diseases to prevent later populations from infections. Or the Tuskeegee experiments, in which black males suffering with syphilis were not administered penicillin, in order to observe the progression of the disease. Elderly male nursing home patients were injected with cancer viruses to see if they would form antibodies.31 Mentally retarded children in state institutions were fed feces to study hepatitis.32 And most recently, the U.S. radiation experiments performed on thousands of unsuspecting patients and urban populations were exposed. All of these experiments were performed without the informed consent of the human subjects. Interesting Interesting that many of such breeches of research ethics took place in experiments involving vulnerable populations of human beings, whose "personhood", perhaps, was considered to be less than adequate. Interesting that much of it was federally funded, and justified "for the greater good of society" or for national security reasons.

In sum, these human embryo experiments are unethical from many perspectives. The science that is used to determine the "moral status" of these early human embryos is incorrect. There is absolutely no question whatsoever, scientifically, objectively, that the life of every human being normally begins at fertilization. There is no question that any attempt to split a human being from a human person philosophically or theologically is theoretically and practically indefensible. Personhood begins when the human being normally begins - at fertilization. Therefore, any experiment which would require the intentional destruction of innocent human beings - even if for the greater good of society, or for the advancement of scientific knowledge, or for the national security - is automatically unethical. Great benefits do not justify unethical means. And finally, given the inherent problems with the status of the famous bioethics principles, as well as the questionable makeup of this NIH Panel and its inherent conflict of interests - and given the Panel's indefensible theory of the moral status of the early human embryo, a theory which is selectively utilitarian and grounded on unscientific bioethics books and literature - none of their Recommendations can be defended, and so are invalid.

But that does not mean that these experiments have not or will not take place - using both private and public funds. They already have taken place,33 and they will continue, unless our collective common sense is restored, the inherent value and dignity of every human being is acknowledged and protected - regardless of its quality of life - and until everyone becomes informatively and actively involved in this critical dialogue.



1 John Rennie, "Trends in genetics: Grading the gene tests", Scientific American (June 1994), 270:6:88-97. [Back]

2 Science News (1994), Vol. 146, p. 299. [Back]

3 See article on obesity, by Rick Weiss, "Born to be fat; Will an obesity gene tilt the scales toward social acceptance?", Washington Post (Dec. 6, 1994),  p. 10-14. [Back]

4 National Institutes of Health: Report of the Human Embryo Research Panel, September 27, 1994; available free of charge from Ms Peggy Schnoor, Division of Science Policy Analysis and Development, National Institutes of Health, Bldg. 1, Room 218, 9000 Rockville Pike, Bethesda, MD 20892; phone 301-496-1454. [Back]

5 C. Ward Kischer, "A new wave dialectic: The reinvention of human embryology", Linacre Quarterly (1994), 61:4:66-81; Kischer, "Human development and reconsideration of ensoulment", Linacre Quarterly (1993), 60:1:57-63; Kischer, "Quid sit veritas?", Science For Life (July 1994), 4:1:1-10; Dianne N. Irving, "Testimony before the NIH Human Embryo Research Panel", Linacre Quarterly (1994), 61:4:82-89; Irving, "Academic fraud and conceptual transfer in bioethics: Abortion, human embryo research and psychiatric research", in Proceedings of the Conference: Life and Learning IV (New York: Fordham University Press, Fall 1994), in press; Irving, "'New age' embryology text books: Implications for fetal research", Linacre Quarterly (1994), 61:2:42-62. [Back]

6 Dianne N. Irving, Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (Dissertation submitted to the Graduate School, Georgetown University, Washington, D.C., April 9, 1991). For shorter summaries, see Irving, "Science, philosophy and expertise: An evaluation of the arguments on 'personhood'", Linacre Quarterly (1993), 60:1:18-46; Irving, amicus curiae brief (for University Faculty For Life, Members of Congress, organizations and individuals) in support of petition of certiorari, Alexander Loce v. The State of New Jersey, cert. denied __ U.S. __ (1994)  (No. 93-1149). [Back]

7 45 C.F.R. Part 46 (1993). [Back]

8 NIH Revitalization Act (1993), P.L. No. 103-43, codified at U.S.C. sec 289a et seq. [Back]

9 Joseph Palca, "A word to the wise", Hastings Center Report (Mar.-April 1994),  p. 5. [Back]

10 National Institutes of Health: Report of the Human Embryo Research Panel (see note 4),  p. 5-7. [Back]

11 Ibid., p. 10. [Back]

12 Ibid., p. 11-12. [Back]

13  See series of articles on this issue since January 1994 by: Mary Meehan, in National Catholic Register, Richard Doerflinger, in National Right to Life News and The Catholic Standard; Mark Zimmerman, in The Catholic Standard; and American Life League (Stafford, VA, phone 703-659-2586). Also see articles by: Rev. John Richard Neuhaus, "Don't cross this threshold", Wall Street Journal (Oct. 27, 1994), and the Ramsey Colliquium's statement, "The inhuman use of human beings: A statement on embryo research by the Ramsey Colloquium" to be published in First Things (Jan. 1995); Peter Riga, "Letter to the Editor", Wall Street Journal (Nov. 14, 1994); David Walsh (CU), "Benefits don't make it ethical", The Washington Post (Oct. 27, 1994), A23; "Editorial", The Washington Post (Oct. 2, 1994); George Weigel, "A Brave New World is hatched", Los Angeles Times (Nov. 27, 1994); series of letters to Dr. Varmus from Rep. Robert K. Dornan and Congressional members of the Pro-Life Caucus, U.S. House of Representatives (phone 202-225-2965); statement to Dr. Varmus by Archbishop James Cardinal Hickey, Nov. 12, 1994 (all of the statements pro and con this research which were sent to NIH are open for public reading). Also see Dianne N. Irving, "Embryo research: A call for closer scrutiny", National Catholic Register (July 17, 1994). Also see Irving, interviewed by: Diane Gianelli, "Embryo research decision set to spark controversy", American Medical News (June 1994), p. 7; Pete Sheehan, "Moral experts concerned about reported cloning", The Long Island Catholic (Nov. 3, 1993), p. 9; Mary Meehan, "Halt these proceedings", National Catholic Register (June 1994); ibid, "Dialogue: Dianne Nutwell Irving on embryology and bioethics" (Oct. 16, 1994), p. A1; Richard Szczepanowski, "NIH decision on embryo research said to be based on faulty science", Catholic Standard (Nov. 3, 1994), p. 4; Edward C. Freiling, "The attempted justification of embryo research", The Wanderer (Dec. 8, 1994), p. 12; and by Cheryl Wetzstein, "Activists oppose embryo research", The Washington Times (Dec. 8, 1994) p. 12.[Back]

14 NIH Revitalization Act 1993, 42 U.S.C. sect. 289 a-1(b)(1). [Back]

15 National Institutes of Health Human Embryo Research Panel: Transcripts of the Meetings (Feb. 2-3, Mar. 14, Apr. 11-12, May 3-4, June 21-22, and Sept. 27), available free of charge from Ms Peggy Schnoor, Division of Science Policy Analysis and Development, National Institutes of Health, Bldg. 1, Room 218, 9000 Rockville Pike, Bethesda, MD 20892; phone 301-496-1454. Also free of charge are copies of all of the "invited papers" from the "experts" which NIH commissioned for this Human Embryo Research Panel. [Back]

16 Federal Advisory Committee Act, 5 U.S.C. App. sect 5(b) (2); see petition for injunction, Mary Doe v. Donna Shalala, et al, U.S. Dist. St. MD, No. PJM-94-1703,  filed Aug. 1994, cert. denied. [Back]

17 See articles by Mary Meehan and Richard Doerflinger (note 15). [Back]

18 Dianne N. Irving, "Testimony before the NIH Human Embryo Research Panel", Linacre Quarterly (1994), 61:4:82-89; Irving, "Academic fraud and conceptual transfer in bioethics: Abortion, human embryo research and psychiatric research" (see note 5). [Back]

19 See Meehan and Doerflinger (note 15). [Back]

20 D. Irving (note 5); see also, Francis J. Beckwith, "Book review: 'A Matter of Principles: Ferment in U.S. Bioethics', in Ethics and Medicine (Fall 1994). [Back]

21 Dianne N. Irving, "Which ethics for science and public policy?", Accountability in Research (1993), 3:2-3:77-99; Irving, "The impact of scientific 'misinformation' on other fields: Philosophy, theology, biomedical ethics and public policy", Accountability in Research (April 1993), 2:4:243-272; Irving, "Quality assurance auditors: Between a rock and a hard place", Quality Assurance: Good Practice, Regulation, and Law (March 1994), 3:1:33-52. See also, DuBose, Edwin, Hamel, O'Connell (eds.), A Matter of Principles? Ferment in U.S. Bioethics (Valley Forge, PA: Trinity Press International, 1994); Raanan Gillon (ed.), Principles of Health Care Ethics (New York: Wiley, 1994); (many other cites found on BIOETHICSLINE under "analytics/bioethics"). [Back]

22 National Institutes of Health: Report of the Human Embryo Research Panel (see note 4), p.110-111. [Back]

23 Peter Singer, Helga Kuhse, Stephen Buckle, Karen Dawson, Pascal Kasimba, Embryo Experimentation (New York: Cambridge University Press, 1990). [Back]

24 Singer et al, Embryo Experimentation, p. xiv. [Back]

25 Kischer, "Quid sit veritas?", Science for Life (July 1994), 4:1:1-10; also, "A new wave dialectic: The reinvention of human embryology", Linacre Quarterly (1994), 61:4:66-81; Irving, "Academic fraud..." (see note 5). [Back]

26 Albert Jonsen, "Preface", in DuBose et al; and Gillon (note 24); Daniel Callahan, "Bioethics: Private choice and common good", Hastings Center Report (May-June 1994), 28-31. [Back]

27 D. Irving, "Academic fraud..." (note 5); ibid, "Impact of scientific 'misinformation..." (note 24); ibid, "Psychiatric research: Reality check", The Journal of the California Alliance for the Mentally Ill (Spring 1994), 5:1:42-44; ibid, "Can either scientific facts or 'personhood' be mediated?", Pontis (The Center for Medical Ethics and Mediation, San Diego, CA)(March 1994), 2:1:3-5; ibid, "Politization of science and philosophy: The 'delayed personhood' debates and conceptual transfer", Life Science And The Concept of 'Person', Centre d'Etudes sur la Reconnaissance de la Personne Humaine (CERPH, CHU La Miletrie, B.P. 577, 86021 Poitier, France), forthcoming; ibid., "Neurobiolgical research using human subjects: Ethical choices for decision makers", Accountability in Research (Feb. 1995), forthcoming. [Back]

28 Nuremberg Code, in Jay Katz, Experimentation With Human Beings (New York: Russell Sage Foundation, 1972), p. 305-306. [Back]

29 Declaration of Helsinki, in Robert J. Levine, Ethics and Regulation of Clinical Research (New Haven: Yale University Press, 1986), p. 429. [Back]

30 United States Code of Federal Regulations: Protection of Human Subjects 45 CFR 46 (available from NIH, Office For The Protection from Research Risks). [Back]

31 Paul S. Appelbaum, Charles W. Lidz and Alan Meisel, Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 1987), p. 217-218; Robert J. Levine, Ethics and Regulation of Clinical Research (New Haven: Yale University Press, 1986), pp. 69-72. [Back]

32 Dr. Bernandine Healy, former Director of NIH (under President Bush), debating Ron Green (NIH Panelist and "ethicist") on MacNeil-Lehrer News Hour (Dec. 6, 1994) (Transcripts available from "Strictly Business", P.O. Box 12803, Overland Park, Kansas 66212, phone 913-649-6381). [Back]

33 As confirmed publicly by Ron Green, NIH Panelist, on MacNeil-Lehrer News Hour (note 35). [Back]