What is "Bioethics"? pg.6

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C. The NIH Human Fetal Tissue Transplant Conference:

On March 22, 1988 the Assistant Secretary of DHHS Dr. Windom finally placed a moratorium on the use of some types of fetal tissue in research at DHHS until an advisory committee could review the issue more fully. Immediately the National Institutes of Health convened such meetings with the NIH Human Fetal Tissue Transplantation Research Panel, recommending that the use of fetal tissue from aborted fetuses was "ethical".133 However, because of the deep divisions within the panel, the Secretary of DHHS declined to accept it.134 The appointed members of the NIH Human Fetal Tissue Transplant Conference included:

Chairman was Arlin Adams (U.S. Court of Appeals Judge, lawyer at Schnader, Harrison, Segal and Lewis). Chairman for Scientific Issues was Kenneth Ryan (research scientist and former Chairman of the National Commission, Chairman of the Department of Obstetrics and Gynecology at Brigham and Women's Hospital); and Chairman of the Ethical and Legal Issues was LeRoy Walters (Director of the Center for Bioethics at Georgetown University). Members of the Panel were: Rabbi David Bleich (Professor of Law at Cardozo Law School in New York); James Bopp (lawyer at Brames, McCormick, Bopp and Abel in Indiana); Fr. James Burtchaell (Professor of Theology at the University of Notre Dame); Robert Cefalo (physician/researcher at the University of North Carolina School of Medicine at Chapel Hill, North Carolina); James Childress (Chairman of the Department of Religious Studies at the University of Virginia); (Dan Clouser (Professor of bioethics at the Hershey Medical Center at Pennsylvania State University); Dale Cowan (hematologist/oncologist at Marymount Hospital in Ohio); Jane Delgado (President and Chief Executive Officer of the National Coalition of Hispanic and Human Services Organizations, Washington, D.C.); Bernadine Healy (physician, Chairman of the Research Institute, Cleveland Clinic Foundation in Ohio); Dorothy Height (President of the National Council of Negro Women, Alexandria, Virginia); Barry Hoffer (Professor of Pharmacology in the Department of Pharmacology, University of Colorado); Patricia King (Professor of Law at Georgetown University Law Center); Paul Lacy (Professor of Pathology at Washington University School of Medicine in St. Louis, Missouri); Joseph Martin (Chief of the Neurology Service at Massachusetts General Hospital); Aron Moscona (Professor in the Department of Molecular Genetics and Cell Biology at the University of Chicago); John A. Robertson (Baker & Botts Professor of Law at the University of Texas School of Law); Daniel Robinson (Chair of the Department of Psychology at Georgetown University); and Rev. Charles Swezey (Annie Scales Professor of Christian Ethics at Union Theological Seminary in Richmond, Virginia).135

D. The NIH Human Embryo Research Panel:

In 1993, the newly elected President Clinton revoked the moratorium on federal funding of research using human fetal tissue by signing into law The NIH Revitalization Act of 1993,136 which also "just happened" to delete the requirement for an EAB approval of IVF research,137 (which is a form of human embryo research, as are cloning research, stem cell research, chimera research, etc.). Thus fetal tissue transplant research and IVF research were permitted to receive federal funding. Immediately the NIH appointed its Human Embryo Research Panel:138

Chairman of the Panel was Steven Muller (President Emeritus at The Johns Hopkins University). Co-Chair for Policy was Patricia King (Professor of Law, Georgetown University Law Center); Co-Chair for Science was Brigid Hogan (Hortense B. Ingram Professor in the Department of Cell Biology at Vanderbilt University School of Medicine); Co-chairs for Ethics were Sister Carol Tauer (Professor in the Department of Philosophy at the College of St. Catherine in St. Paul, Minnesota), and Ronald Green (John Phillips Professor of Religion, and Director of the Ethics Institute at Dartmouth College). Members included: Diane Aronson (Executive Director of RESOLVE); Alto Charo (Assistant Professor of Law and Medical Ethics at the University of Wisconsin); Patricia Donahoe (Chief of Pediatric Surgery at the Massachusetts General Hospital); John Eppig (Senior Staff Scientist at The Jackson Laboratory in Bar Harbor, Maine); Fernando Guerra (Director of the Department of Health at San Antonio Metropolitan Health District); Andrew Hendrickx (Professor of Cell Biology and Human Anatomy, and Director of the California Regional Primate Research Center at the University of California, Davis); Mark R. Hughes (Associate Professor of Molecular Genetics, Cell Biology, and Medicine, and Director of the Prenatal Genetics Center at Baylor College of Medicine); Ola M. Huntley (Member of the Board of Directors of the Sickle Cell Self-Help Group in Inglewood, California); Nannerl Keohane (President of Duke University); Bernard Lo (Director of the Program in Medical Ethics at the University of California, San Francisco); Mary C. Martin (Associate Professor and Director of the IVF Program in the Department of Obstetrics, Gynecology, and Reproductive Sciences in the School of Medicine at the University of California, San Francisco); Thomas Murray (Director of the Center for Biomedical Ethics at Case Western Reserve University School of Medicine); Dorothy Nelkin (Professor in the Department of Sociology at New York University).139

Ironically, the Chairman of the Panel stated publicly that only those who agreed with human embryo research per se should be on the NIH Panel and only those "voices of the public" who likewise agreed should be seriously considered.140 Again, not one member of the panel was a human embryologist. Of note, again, is the persistent use and acceptance of the scientifically erroneous term "pre-embryo" during the Panel's considerations in its meetings,141 as well as in the Panel's commissioned papers, and in testimonies by major organizations such as the American College of Obstetricians and Gynecologists (ACOG), the American Fertility Society (AFS), and their offspring -- the National Advisory Board on Ethics in Reproduction (NABER).142 The official, and scientifically erroneous, definition of "fetus" as still contained in the official federal guidelines (the OPRR guidelines) was likewise still accepted.143 The Panel and their testifiers seemed hopelessly confused as to what the correct science of human embryology required here should be, and oblivious to the fact that the term "pre-embryo" was formally rejected by human embryologists and grounded on very erroneous science.144 Nevertheless, the term (or it's surrogate term "pre-implantation embryo", which was intended to mean the same thing morally as the term "pre-embryo") was one of the major considerations for the Panel's conclusions that the early human embryo had a "reduced moral status", and therefore its use in experimental research was "ethical".145

The NIH Panel's Report was met with rounds of criticisms -- including those who argued that the Panel's "restrictions" on some kinds of human embryo research were too narrow and would stifle scientific progress, and that it failed to provide a coherent moral justification for allowing such research.146 In the end, the recommendations of the NIH Panel were approved by the Advisory Committee of NIH. However, President Clinton did reject the use of federal funds for studies using made-for-research human embryos. In 1996 Congress would respond by passing a ban on federal funding of human embryo research.147 Private funding of all these types of research has never been federally regulated.

E. The National Bioethics Advisory Commission

In 1995 President Clinton appointed The National Bioethics Advisory Commission (NBAC),148 the "national ethics advisory board" which had been held in limbo for so long. However, its mandate now reached far beyond consideration of the issues of IVF research or fetal research, and far beyond the application to just one section of one federal department. The creation of NBAC once again federalized and concretized bioethics "theory", principles, definitions, methods and erroneous human embryology -- as evident in its own charter, its appointed members, its commissioned papers, and its conclusions. All arguments challenging the very legitimacy of bioethics, its "theory", principles, methods, appointed members, commissioned papers, and use of erroneous science were ducked, as has always been the case.

The stated functions of NBAC are to "provide advice and make recommendations to the National Science and Technology Council and to other appropriate government entities" regarding (1) the appropriateness of departmental, agency, or other governmental programs, policies, assignments, missions, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior; and (2) applications, including the clinical applications, of that research. NBAC also identifies broad principles to govern the "ethical" conduct of research -- "ethics" being used and defined, of course, primarily in terms of the bioethics prinicples as they were defined in The Belmont Report and by the earliest bioethcists. (This is just one of many examples of how bioethics itself has defined "ethics per se" only in terms of "bioethics".) NBAC is also responsible for the review and approval of specific projects.

In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. NBAC also may identify other bioethical issues for the purpose of providing advice and recommendations, subject to the approval of the National Science and Technology Council. It's first priority is to direct its attention to consideration of protection of the rights and welfare of human research subjects, and issues in the management and use of genetic information, including but not limited to, human gene patenting. In establishing the other priorities for its activities, NBAC uses four criteria for its considerations: (1) the public health or public policy urgency of the bioethical issue; (2) the relation of the bioethical issue to the goals for Federal investment in science and technology; (3) the absence of another entity able to deliberate appropriately on the bioethical issue; and, (4) the extent of interest in the issue within the Federal Government.

It is clear, however, that these four "criteria" are essentially utilitarian in nature, conflicting by definition with NBAC's purported "first priority" to protect human subjects in research. The means by which to resolve this inherent conflict will be in terms of "weighing and measuring" the conflicting moral positions and then arriving at a "consensus". The scientific facts demonstrating that a human being begins at fertilization are cast merely in terms of "belief systems" or "moral positions" -- thus allowing them to be "weighed and measured" along with other "moral positions". Incredibly and indefensibly, NBAC even assumes without argumentation that the philosophical arguments for "delayed personhood" carry more weight than those for "immediate personhood",149 as do most of their commissioned papers.150

NBAC too accepts the federal OPRR guidelines for its deliberations, which federal guidelines still include the scientifically erroneous definitions of "pregnancy" and of "fetus" as both beginning at implantation.151 In its charter, reports and commissioned papers NBAC is essentially building on the bioethics "precedents" and ediface already laid down from the National Commission onward, including their acceptance of the "reduced moral status" of the early human embryo. Thus once again, the early human embryo is not acknowledged as a human research subject. To put it bluntly, the same ole same ole.

The appointed members, and some other staff or consultants of NBAC are:

Chairman Harold Shapiro (President of Princeton University). Members: Patricia Backlar (Research Associate Professor of Bioethics in the Department of Philosophy at Portland State University, and Assistant Director of the Center of Ethics in Health Care at Oregon Health Sciences University); Arturo Brito (Assistant Professor of Clinical Pediatrics at the University of Miami School of Medicine); Alexander Morgan Capron (Henry W. Bruce Profess of Law and University Professor of Law and Medicine and Co-Director of the Pacific Center for Health Policy and Ethics at the University of Southern California at Los Angeles); Eric J. Cassell (Clinical Professor of Public Health at Cornell University Medical College); Alto Charo (Professor of Law and Medical Ethics at the Schools of Law and Medicine at the University of Wisconsin); James F. Childress (Kyle Professor of Religious Studies and Professor of Medical Education and Co-Director of the Virginia Health Policy Center in the Department of Religious Studies at the University of Virginia); David Cox (Professor of Genetics and Pediatrics at Stanford University School of Medicine); Rhetaugh Duman (Vice Provost Emerita, Dean Emerita, and Lucille Cole Professor of Nursing at the University of Michigan); Laurie Flynn (Executive Director of the National Alliance for the Mentally Ill, Arlington Virginia); Carol Greider (Professor of Molecular Biology and Genetics in the Department of Molecular Biology and Genetics at The Johns Hopkins University School of Medicine); Steven Holtzman (Chief Business Officer at Millennium Pharmaceuticals Inc., Cambridge, Massachusetts); Bette Framer (Founding President of Richmond Bioethics Consortium, Richmond Virginia); Bernard Lo (Director of the Program in Medical Ethics at the University of California, San Francisco); Lawrence Milke (lawyer, Kaneohe, Hawaii); Thomas Murray (President of The Hastings Center); Diane Scott-Jones (Professor in the Department of Psychology at Temple University). Executive Director Eric Meslin (Ph.D. in philosophy with a concentration in bioethics from The Kennedy Institute of Ethics and the Department of Philosophy at Georgetown University). Bioethics consultants: LeRoy Walters, (Director of the Kennedy Institute of Ethics at Georgetown University); Jeffrey Kahn; numerous other staff.152

It is not difficult to understand why NBAC would be agreeing with the DHHS legal counsel that federal funding of human embryonic stem cell research could "ethically" go forward.153

F. The NIH Guidelines for Research Involving Human Pluripotent Stem Cells:

Despite the 1996 Congressional ban on human embryo research, in December 1999 the National Institutes of Health (NIH) announced its Draft Guidelines for Research Involving Human Pluripotent Stem Cells, in which it argued that by its reading of the ban on human embryo research NIH funds (only) could be used to fund research using human embryonic and fetal stem cells which were privately derived.154 The Guidelines were finalized and published in August 2000.155

Aside from any number of serious problems associated with these guidelines, of particular interest once again are the definitions of a "human embryo" and a "human being" provided by NIH Director Harold Varmus in his testimony before a subcommittee of the Senate of the United States.156 By this time many in the bioethics lobby had judiciously avoided the use of the scientifically erroneous term "pre-embryo", so that term could no longer be used as their "scientific" justification for using human embryos in research. A new term was required to fill this void.

In his official testimony Varmus stated that a human embryonic zygote [he used the term, "the product of fertilization of an ovum"] and all its developing stages up to the blastocyst stage [5-7 days after fertilization], is just a collection of "totipotent stem cells" [i.e., just "parts" of an embryo] which only have the "potency" to become "a mature human organism" - but even then "only if it is implanted". That is, Varmus defined an embryo as just stem cells, rather than as a whole human organism which consists, in part, of stem cells. This definition of a human embryo is patently scientifically false and thoroughly misleading.157 It would seem that the scientifically erroneous term "pre-embryo" has now been replaced by the equally scientifically and erroneous term "just stem cells".158

And the inevitable question arises, "Where are all the good scientists?" How could they have remained so silent for so long about all this crude and blatantly erroneous "science", which has now infiltrated and embedded itself into so many textbooks, court decisions, laws, regulations and "commission reports", and now in this testimony by the Director of NIH before a Senate subcommittee?

The science of human embryology has long demonstrated beyond any doubt whatsoever that these early human embryonic stages to which Dr. Varmus referred are all really developing stages of a whole human being, not of just a part of a human being, e.g., not of just stem cells alone. A stem cell is only a part of a whole organism; an organism (such as a human being) is the whole thing. Further, while it is true that the single-cell human embryonic zygote, and the cells of the developing human organism up to the blastocyst stage, are "totipotent" (relatively speaking, and actually a passe term now, given Dolly and other recent cloning experiments), it is also scientifically true that those same stem cells when separated from the whole embryo (referred to as fission, or asexual twinning or cloning) would each singly be a new whole human embryo, i.e., a new human being. Thus the term "totipotent" can properly refer only to the cells of the early embryo while they are part of that whole embryo, and not when they are separated from that embryo. Further, the developing embryonic human being does not just have a "potency" (or a "potential human being") to develop later into a human being, as Dr. Varmus states. Scientifically we know that it already is a living human being. The terms "potency" and "potential" are not scientific terms but are mediaeval scholastic philosophical terms -- and have always been misapplied in these debates at that. These philosophical terms should play absolutely no role whatsoever in determining scientifically when a human being begins -- that is a strictly scientific question, which should be answered by the experts in this field -- human embryologists.159 Politicians, philosophers, lay commissioners, lawyers and physicians have no academic credentials or academic standing to redefine the scientific field of human embryology.

Perhaps the most amazing "scientific" statement by Director Varmus before the Senate sub-committee was his definition of a "human being" -- that these early totipotent and pluripotent "cells" will not become a "mature human organism unless and until it is implanted." This too is decidedly misleading, but not surprising, given the continuous and erroneous scientific definitions of a "human being" throughout all of these bioethics events. Circumstantially, it is true to say that if an already existing embryo is not implanted it will die -- i.e., it will not be allowed to mature to its adult stage of development. But that does not mean that this early embryo is not yet a human being. Scientifically, the single-cell embryonic human zygote and all of its early developmental stages is already a human being (i.e., a human organism), regardless of whether or not it is implanted. Scientifically we know that every human being begins his or her physical existence at fertilization (or cloning). Implantation, or lack thereof, simply refers to whether or not an already existing whole human being will continue to exist or not. No change of what it is takes place at implantation, only whether or not the whole human being that is already there continues to live and grow. It is really quite simple: if the early human being implants, then it can live and grow to maturity; if it doesn't implant, then the early human being will die young.

And Dr. Varmus' use of the phrase, "an entire mature human organism, e.g., a human being," is not only scientifically misleading - it is scientifically bizarre. A "mature human organism" is only one of many stages of development of a whole human being - hardly the only stage. Scientifically, the embryonic organism and the mature organism are one and the same organism. The embryonic organism is just younger and at a less developed stage of growth. This definition of a "human being" by Dr. Varmus would actually define a "human being" as just a mature organism! And this from the senior scientific research officer of the United States. It is no wonder that human embryologists have never been included in these bioethics proceedings.

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