"Affidavit in support of petition for injunction of the NIH Human Embryo Research Panel, Mary Doe v. Donna Shalala, et al,"

Dianne N. Irving
August 1994

In the United States District Court
For the District of Maryland

MARY DOE, preborn child, et. al.,
Plaintiffs: CIVIL ACTION NO.: PJM-94-1703
DONNA SHALALA, et. al., :Defendants
Reproduced with Permission

I, the undersigned, reside at 5108 Randall Lane, Bethesda, Montgomery County, Maryland.

My name is Dianne Nutwell Irving, M.A., Ph.D. My first professional training was as a research biochemist. I worked as such for almost 6 years at the National Institutes of Health, National Cancer Institute, Bethesda, Maryland, receiving a career appointment there as a research chemist. I subsequently received my Master of Arts Degree in metaphysics and epistemology, and my Doctoral Degree in Philosophy with concentrations in bioethics and the history of philosophy, from Georgetown University, Washington, D.C. (see resume, Attachment A). The title of my doctoral dissertation was: Philosophical and Scientific Analysis of the Nature of the Early Human Embryo (see dissertation, Attachment B). The major question addressed in the dissertation was: "Is it ethical to use 'surplus' IVF-produced human embryos in experimental research? I have subsequently published articles on this issue, and presented papers on it to both professional and lay organizations. I also personally testified before the NIH Human Embryo Research Panel on March 14, 1994 (see NIH testimony, Attachment C).

I have been following this issue closely for several years, and I am deeply concerned about the excessive bias inherent in this NIH Panel, in particular on four counts: (1) the legitimacy of the "ethical principles" which this Panel is using to determine if the proposed research is "ethical"; (2) the use of incorrect science (and philosophy) in virtually every argument to determine the moral status of the human embryos to be used in experimental research advanced by or assumed by this Panel; (3) the unethical character of most of the research proposals being discussed - even from a purely scientific standpoint; and (4) the conceptual transfer of so-called "personhood" criteria for moral status - already set in the abortion and fetal tissue transplant research debates, and now taking place in these NIH Human Embryo Research Panel invited papers, discussions and transcripts - to virtually millions of American adult human populations.

First, this NIH Panel - as several NIH panels and commissions before it - is ostensibly using those "ethical principles" formulated and advanced originally by the National Commission (1975) (chaired by Kenneth Ryan and on which Patricia King served). These are the so-called "bioethics principles" of autonomy, justice, beneficence and non-maleficence. These principles, in fact, were "constructed" (or one might say, "fabricated") by that Commission (Al Jonsen), are philosophically and ethically indefensible at the more sophisticated philosophical level, and have been the object of considerable objections and scrutiny in the last several years (O'Connor, Beckwith, Callahan). It has become crystal clear even to those in the field of bioethics that these "ethical principles" are no longer viable or defensible, and are in critical need of replacement. Therefore it is inappropriate for this Panel to even ostensibly use these "ethical principles" as the basis for their judgments as to which research experiments are ethical or unethical.

In addition, the "ethicists" (more accurately, "bioethicists") on this Panel have actually often been using, in addition, a mish-mash of different "ethical theories" to justify these research experiments (specifically by Carol Tauer and Benard Lo, and within discussions by many of the other panelists) -none of which have been subjected to review, debate or consensus even by those in the field of "bioethics", much less the philosophical academic community. Indeed, their "ethical" discussions are mis-lead, misinformed, unsophisticated, arbitrary, and inconsistently applied in their deliberations. There is no such thing as a "neutral" ethics - yet there is the clear presumption in their deliberations that somehow "utilitarianism" or "pragmatism" are ethical theories which are somehow neutral and therefore should be used to determine what is "ethical" in our pluralistic, democratic society. Indeed, in the face of their mandate to recommend which experiments are "ethical" or not, some have advocated abandoning any "ethical" considerations at all. Bioethicist Thomas Murray stated that, "Even if there was a relative social unanimity on a particular ethical issue [such as the moral status of the human embryo]", the question whether an experiment is unethical needn't determine whether it is publicly funded (NIH March transcripts). Therefore, these panelists are also inappropriately manufacturing their own "ethical theories" on which the entire Panel is to base their conclusions, or they are abandoning any ethical considerations at all - as well as abandoning their mandate - in determining which research is ethical and which is unethical.

Second, the conclusions about the moral status of the human embryo have been grounded for years on incorrect science (and philosophy) (see dissertation, Attachment B; and UFL amicus curiae brief, Attachment D; and "Background Material", Attachment E). In analyzing 23 representative arguments for so-called "delayed personhood" in the developing human embryo or human fetus, I demonstrated that in virtually all 23 arguments the science used as the ground for "delayed personhood" was textbook incorrect. In particular, one of the most quoted scientific arguments originated from Clifford Grobstein (member of the 1978 HEW Ethics Advisory Board, the Ethics Committee of the American Fertility Society, and consultant to NIH), and was used by the theologian Richard McCormick. Together they argued that the early developing human embryo was only a "pre-embryo" - i.e., (possibly) a human being, but that he or she was not an "individual" as yet, and therefore was not a "person" yet, and therefore not deserving of the same ethical and legal rights and protections as developmentally individual human beings. They called these human pre-individuals "pre-embryos" (read "pre-persons"), and justified as "moral", among other things, the use of these "pre-persons" in destructive experimental research.

These published arguments have been propagated in the scientific and bioethics literature for many years. They are often used or implied by the members of this Panel in their discussions and deliberations. Indeed, "bioethicist" Carol Tauer based much of her dissertation on the moral status of the early human embryo on the Grobstein-McCormick arguments. The term "pre-embryo" was also touted by the American Fertility Society and the American College of Obstetricians and Gynecologists, as well as transferred to many international commissions studying these same issues.

However, there is no such thing, scientifically, as a "pre-embryo". Clifford Grobstein is not himself a human embryologist but rather a specialist in amphibian embryology. The "embryology" which he has been promoting as human embryology is not correct human embryology - and he himself has admitted this on at least two occasions of which I am personally aware. Dr. C. Ward Kischer of the Department of Anatomy, University of Arizona, who has been teaching human embryology for over 25 years, has contacted the major "deans" of human embryology - all of whom reject the term "pre-embryo" as unscientific and incorrect human embryology (see statement by Dr. Kischer to be read by me in my testimony before the NIH Panel, end of my NIH testimony, Attachment C; Dr. Kischer's paper "Human Development ...", Attachment F; and Dr. Kischer's letter to the Linacre Quarterly, Attachment G). If the embryology on which the moral status of the human embryo is grounded is incorrect, then those conclusions about "delayed personhood", or the moral status, of the human embryo are also incorrect, and should not be used as the basis of determining the moral status of the human embryos to be used in the research being reviewed by any member of this or any other Panel. (The philosophy used in virtually all 23 representative arguments for "delayed personhood" is also historically incorrect or blatantly indefensible. See Attachments B, and UFL amicus curiae brief, Attachment D).

Even though the scientist who promoted this incorrect embryology admits that he was using incorrect "human" embryology, and even though that embryology has been determined to be incorrect human embryology by all of the "deans" of human embryology, my attempts, professionally, to correct the science (and philosophy) have been ignored or rejected with a smile. When presenting my testimony before the NIH Panel, there was virtually no correction of my corrections by any member of the Panel - nor could there be. There was virtually no comment. How could the largest medical research institute in the world not notice or care that they are and have been using incorrect embryology? This in itself is preposterous, and deserves further investigation. In fact, there is no human embryologist on this NIH HUMAN Embryo Research Panel. The clear implication, given the scientific facts, is that they must not have wanted a human embryologist on this Panel, for to be "forced" to use the correct human embryology would "force" very different conclusions about the moral status of these human embryos, and thus might endanger their own justifications for using these human embryos in destructive experimental research. Dr. Kischer's attempts to correct this embryology have been an exercise in futility (see his article "Quid sit Veritas", Attachment H), and a clear indication of how pervasive and powerful the proponents of human embryo research really are.

Third, most of the proposed research is unethical even on scientific grounds. The most basic requirement for research, if it is to be ethical, is that the science being used to design the protocol and to analyze the data is correct science. The NIH cannot have it either way. Either the "embryology", which they are espousing and which is directly implied in their conclusions about the moral status of the human embryo, is correct human embryology, and thus they must use it in designing their protocols and in analyzing their data - or this embryology is incorrect, and they cannot use it in designing their protocols and in analyzing their data. If the first alternative is taken by NIH scientific grantees, and given that this embryology is unambiguously incorrect, then it is clear that their scientific protocols and their data are by definition scientifically incorrect and thus unethical, and should not be used. If the second alternative is taken by NIH scientific grantees, i.e., the admitted use of incorrect embryology, then the same conclusions follow. In either case, the use of incorrect human embryology in their scientific protocols and used in analyzing their data could clearly cause considerable harm not only to the human embryos used during their experiments, but also to the thousands of human patients to whom these incorrect data could or will be applied in the clinical setting.

In addition, another basic requirement for ethical research is that the design of the protocol be ethical. That is, no matter how important or desirable the end or goal of the experiment is, the experiment is unethical if the very design of the protocol is unethical. This is in fact the case with most of these experiments. It is unethical to design a research protocol which requires that innocent living human beings are destroyed. No mother or surrogate has the right to give consent for another human being to be destroyed - even for the "advancement of scientific knowledge", or for the greater good of society and the discoveries of cures for dreaded diseases.

Furthermore, if the means used to reach even laudatory goals are unethical, then the entire experiment is unethical. That is, if in order to advance scientific knowledge or to cure diseases it is necessary to perform experiments in which live human embryos are destroyed (the means) in order to reach those laudatory goals, then these experiments are also unethical. Therefore, from just these three most basic of requirements in order that any research experiment be considered ethical, most of the research being considered by this Panel is unethical and should not be sanctioned, justified or permitted.

We have been down this path before. Millions of human beings who were arbitrarily deemed "non-persons" and "unwanted" by authorities, especially those in government, academia and genetics, were the subjects of horrific medical experiments, since "they were going to die anyway, and some good might come of using them in medical research" for the advancement of scientific knowledge, the curing of diseases - and the good of the Nazi regime which advanced such horrific experiments. No human being - no matter how tiny - should be arbitrarily proclaimed a "non-person" and subjected to destruction and death, no matter how laudatory the goals.

Fourth, regardless of one's position on abortion, fetal tissue transplant research or human embryo research, the "conceptual precedents" on "personhood" which have already been set in those debates are transferable to millions of unsuspecting adult human populations (see UFL amicus curiae brief, Attachment D). It is argued in these debates that "personhood" does not begin until (a) the actual exercising of so-called "rational attributes" (e.g., autonomy, willing, choosing, relating with the world around one, etc.), or (b) the attainment of "sentience" (the ability to feel pain or pleasure, dependent on the formation of the primitive streak, the formation of the nerve net, or later brain-related criteria). Scientifically, virtually all of these arguments fail (see dissertation, Attachment B). Empirically we know that full "rational attributes" and full "sentience" are not attained until years after birth, leading many bioethicists to argue that the infanticide of normal healthy human infants is morally permissible - and should be legally permissible. For example, Peter Singer (espoused, e.g., by Kenneth Ryan), an internationally influential bioethicist, founder of "animal rights" philosophy, and long time advocate of fetal and human embryo research, has published: "If the fetus does not have the same claim to life as a person, it appears that the newborn baby does not either, and the life of a newborn baby is of less value than the life of a pig, a dog, or a chimpanzee" (see end of UFL amicus curiae brief, Attachment D).

At least Singer has pushed the logic correctly - although his "logic" rests on incorrect scientific and philosophical grounds - and this same logic can be further pushed, correctly. If there is only a human being present but no "person" present until the exercising of "rational attributes" or "sentience", then the following list of human beings are not human persons: Alzheimer's and Parkinson's patients, the mentally ill and the mentally retarded (such as Defendant Michael in this case), the depressed, alcoholics, drug addicts, the comatose, patients in a persistent vegetative state, paraplegics, the partially paralyzed, patients with multiple sclerosis, etc. That is, these populations of human beings are not "persons", and therefore have little or no ethical or legal rights or protections. Thus they, too, could "logically" be used in destructive experimental research - for the advancement of scientific knowledge or to find cures for devastating diseases.

Once the arguments for "delayed personhood" are accepted in these human embryo research debates, then the logic can legitimately be pushed, and applied to millions of adult "non-persons" as well. The rationale used by many members of this Panel, as well as by their invited "experts", is precisely based on "personhood" beginning with "rational attributes" or "sentience". Therefore, if this rationale is allowed to be set in yet one more debate, yet one more NIH panel, these conceptual precedents for "personhood" are even more justifiably transferable to many other human beings who will also loose their ethical and legal rights and protections.

These are but a few of my concerns with the excessive built-in biases inherent in this NIH Human Embryo Research Panel, but sufficient to conclude that this Panel should be enjoined, and the United States Congress should immediately without delay investigate the legitimate standing of this Panel and its authority to make any recommendations whatsoever as to the "ethical" acceptability of the proposed human embryo research.

Dianne Nutwell Irving, M.A., Ph.D.

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