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Ethical Reviews of Embryonic Stem Cell Research

 

Public Comment before the National Bioethics Advisory Commission

Richard M. Doerflinger

Associate Director for Policy Development

Secretariat for Pro-Life Activities

National Conference of Catholic Bishops

April 16, 1999

The Catholic bishops of the United States believe that ethical review of recent proposals for human embryonic stem cell research is both timely and important. Last week a Working Group at the National Institutes of Health began discussing and revising guidelines for research in what NIH calls "human pluripotent stem cells." Tragically, Administration officials have tried to narrow this discussion, to explore only research on stem cells obtained by destroying live human embryos or harvesting tissue from abortion victims. Working Group members have said that it is not their task to review the ethical issue of whether to proceed with such experiments, but only to prepare guidelines to implement an Administration decision that has already been made. Such experiments, however, pose grave moral problems; the proposed experiments requiring destruction of live human embryos for research purposes are not only grossly immoral but clearly contrary to the will of Congress. Therefore we urge this Commission to expand its vision, to explore the serious moral problems in these proposals as well as the alternatives that can advance medical progress without demeaning human life and dignity.

The significance of morally acceptable alternatives

It is now clearer than ever that new research involving adult stem cells, and other advances in the repair and regeneration of human tissue, offer the promise that embryonic stem cells may simply be irrelevant to future medical progress. I would like to submit for the record some background documentation on this point.

When this Commission issued its 1997 report Cloning Human Beings, it made a significant contribution by placing the exaggerated claims of embryo researchers in a broader perspective. Noting claims that the use of cloning to create and harvest human embryos was necessary to progress in transplantation using stem cells, the Commission said this "might be a rather expensive and far-fetched scenario." The Commission added: "Because of ethical and moral concerns raised by the use of embryos for research purposes it would be far more desirable to explore the direct use of human cells of adult origin to produce specialized cells or tissues for transplantation into patients." The report also noted the prospect of identifying "methods by which somatic cells could be 'de-differentiated' and then 're-differentiated' along a particular path" without creating a human embryo.1

These observations were prophetic. The last two years have seen startling advances in isolating and culturing adult stem cells, and even in the possibilities for de-differentiating and re-differentiating them to produce a broader array of different cells and tissues.2 Advances in the use of growth factors to grow new blood vessels and nerve tissue, and in the use of enzymes such as telomerase to "immortalize" useful cell cultures, also offer enormous promise, both in their own right and in combination with new knowledge about adult stem cells.3

In our view, the moral problem of encouraging the destruction of human embryos for their stem cells is independent of any possible benefit expected from such research. From the time of the Nuremberg Code, ethical norms on human experimentation have demanded that we never inflict death or disabling injury on any unconsenting individual of the human species simply for the sake of benefit to others.4 Stem cell research requiring the destructive harvesting of cells from living embryos fails this test, and should not be supported by the government. Even if the Commission were to find this principled argument inconclusive, the existence of morally acceptable alternatives that do not require the destruction of a human life for research purposes would support the conclusion that support for embryo experimentation is unethical -- because it needlessly relies on the destruction of life to advance medical goals which can be achieved in non-destructive ways.

"Spare" vs. "research" embryos

In this Commission and at NIH, it has been proposed that destructive harvesting of cells from so-called "spare embryos" from fertility clinics (which NIH now calls embryos "in excess of clinical need") may be less immoral than destroying embryos specially created for research purposes. Such a distinction was proposed by President Clinton in December 1994. However, Congress rightly rejected the distinction, and has chosen since 1995 not to fund research involving the destruction of embryos from any source. In 1996, a renewed effort to insert this distinction into federal policy to allow federally sponsored research using only "spare" embryos was soundly rejected by the House of Representatives, 256 to 167.

We believe that in addition to being contrary to the will of Congress, any policy based on a distinction between "spare" and "research" embryos is both morally incoherent and practically unworkable.

Morally, if it is wrong to create a human embryo for the purpose of destructive research, that is largely because destroying embryos for research purposes is itself wrong. Many of us may object when people choose to bring a new human being into the world for self-serving reasons -- but it is when this new being is to be treated as disposable research material that these objections rise to the level of moral abhorrence. Creating embryos for research purposes is wrong because it treats this distinct human being, with his or her own inherent moral worth, as nothing more than a disposable instrument for someone else's benefit. But of course, destroying human embryos -- any human embryos -- for research purposes is wrong for the same reason.5

Conversely, if one were to take the (to us, gravely mistaken) view that human embryos have no inherent moral worth -- that any value or purpose they may have is simply attributed to them by others -- it is difficult to see why someone cannot decide in advance that an embryo's only "purpose" is to serve as raw material for research. In that moral universe, it would seem at least equally problematic to bestow positive value on an embryo as one's "wanted" child and then renege on that decision by choosing to allow destructive experimentation. If a decision to treat a developing human life as a mere object of manipulation is wrong, it is wrong whether planned in advance or decided upon later.

As a practical matter, fertility experts have announced that they (or their colleagues in the industry) will easily evade any policy limited to use of "spare" embryos. They can simply produce more embryos at the beginning of some couples' fertility treatment to ensure a sufficient supply of "spares" for destructive research at the end of the process. Attempts by NIH to prevent such abuses will almost certainly fail, as it would have to find ways to regulate a fertility clinic's internal motivations in creating an embryo. Such efforts will likely succeed only in entangling the federal government further in decisions about creating and destroying human embryos -- decisions in which this Administration claims to want no involvement.6

HHS's untenable interpretation of the embryo research ban

This brings us to the legal interpretation on which the proposed NIH guidelines on embryonic stem cell research are based. The General Counsel of the Department of Health and Human Services (HHS) has issued a legal memorandum arguing that NIH may fund stem cell research requiring the destruction of human embryos, so long as the federal funds are not directly used for the precise act of destroying an embryo. But HHS has overlooked some obvious facts, and created its own arbitrary definition of a human embryo that has no basis in biology or federal law.

Flaws in the HHS interpretation include the following:

It ignores the will of Congress. Already the prime sponsor of the current statutory ban on harmful embryo research, joined by over 75 members of Congress who support this ban, have written to HHS protesting this misinterpretation of the law.

It violates well-established principles of statutory construction. The current ban forbids the use of federal funds for "the creation of a human embryo or embryos for research purposes." But it does not merely forbid the use of these funds to destroy embryos; instead, it bars federal support for any "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero" under federal law (Section 511 of Pub. L. No. 105-277). Rules of statutory construction forbid interpreting this more broadly worded provision to have the same limited scope as the narrowly worded provision on creating embryos that immediately precedes it.7 Clearly, Congress intended to forbid federal support for any part of a research project if that project requires, or relies upon, the deliberate destruction of human embryos. Yet the NIH's draft guidelines allow active support for experiments that rely upon destruction of embryos, and even require federal monitoring of the process for donating and destroying the embryos. Clearly, such destruction is an integral part of these research protocols.

It reverses NIH's own policy and practice interpreting the congressional ban. In 1997, NIH terminated all ties with embryo researcher Mark Hughes, a former member of NIH's Human Embryo Research Panel, because -- in NIH's own view -- Dr. Hughes had violated the congressional ban on funding research in which human embryos are harmed or destroyed. Dr. Hughes had been permitted to conduct preimplantation genetic diagnosis on human embryos so long as he did not use NIH funds and equipment in violation of the statutory ban. His violation was not that he used NIH funds to destroy human embryos, but that he used NIH-funded equipment to analyze genetic material already taken from early human embryos -- and the information thus obtained could be used as a basis for deciding whether to discard some embryos in the future. The NIH clearly found this to be a violation of the ban on supporting "research in which" embryos are harmed or destroyed, and NIH Director Varmus testified to Congress that it would take steps to prevent such violations in the future.8 Now HHS Secretary Donna Shalala has begun treating violations of the law as though they were the norm, arguing to members of Congress that the ban on embryo research does not apply to activities "preceding or following" the destruction of an embryo.9 This reversal of policy can claim no support in the statute or any other authority; it seems designed simply to serve the goal of finding a loophole for the proposed research.

It ignores congressional policy on use of fetal and embryonic tissue from abortions. Although current policy on use of tissue from abortions, formulated in 1993 by a House of Representatives under Democratic control, has its own serious flaws, it clearly forbids the kind of destruction of prenatal life for research purposes that the HHS memo seeks to justify. Fetal tissue from an abortion may only be harvested after the embryo or fetus is dead, and the needs of research are not permitted to influence the abortion decision or the timing or method of an abortion (42 USC §289g-1). By contrast, harvesting of embryonic stem cells would not be done after the embryo is killed; it is precisely what kills the embryo. Embryos would be destroyed by a method whose only reason for existence is the goal of obtaining usable stem cells for research.

It creates a new and arbitrary definition of "embryo." The HHS memo proposes that a living organism of the human species deserves the name of "embryo" only if it can be proved that the organism would have grown to live birth if implanted in a woman's womb. Congress, by contrast, recognizes as an "embryo" any early member of the human species that is a living organism here and now, and requires no test for future anticipated lifespan. Congress is on the side of competent science on this point -- no biology textbook claims that when an unborn child miscarries, for example, this is proof that the child was never an embryo. One might as well say that a child who dies before adulthood was never a child. To exploit HHS's new definition, researchers have already offered to experiment only on diseased or damaged embryos, or even to engineer lethal defects in advance into the embryos they create for research purposes, so they can claim they are not performing "embryo research" with federal funds.10 Such efforts to evade the intent of the law are not worthy of the NIH.

In short, the proposed HHS policy is seriously flawed on legal and scientific as well as moral grounds. It has no more respect for law than it does for vulnerable human life. To build a research policy on this foundation risks discrediting NIH's legitimate research goals, by forging a bond between pursuit of those goals and the deliberate destruction of human life. This Commission should urge the NIH to devote its funds to stem cell techniques and other promising avenues of research that in no way depend upon such killing.11

Endnotes

  1. National Bioethics Advisory Commission, Cloning Human Beings (Rockville, MD 1997) at 30-31.
  2. See: C. Bjornson et al., "Turning Brain Into Blood: A Hematopoietic Fate Adopted by Adult Neural Stem Cells in Vivo," 283 Science 534 (22 January 1999); D. Josefson, "Adult stem cells may be redefinable," 318 British Medical Journal 282 (30 January 1999) ("the need for fetal cells as a source of stem cells for medical research may soon be eclipsed by the more readily available and less controversial adult stem cells"); M. Pittenger et al., "Multilineage Potential of Adult Human Mesenchymal Stem Cells," 284 Science 143 (2 April 1999); L. Johannes, "Adult Stem Cells Have Advantage Battling Disease," The Wall Street Journal, April 13, 1999, B1.
  3. See: "Hearts can grow their own bypasses," USA Today, November 9, 1998; "Designer gene may fight Alzheimer's," MSNBC, January 25, 1998; C. Morales, "Absence of cancer-associated changes in human fibroblasts immortalized with telomerase," 21 Nature Genetics 115-8 (January 1999); R. Larson, "Scientists find new life for old cells," The Washington Times, December 29, 1998, A1.For an overview of advances in repairing and regenerating tissues and organs: R. Langer and J. Vacanti, "Tissue Engineering: The Challenges Ahead," 280 Scientific American 86-9 (April 1999).
  4. "No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur" (Nuremberg Code, reprinted in S. Reiser et al. (eds.), Ethics in Medicine, MIT Press 1977, at 273); "Concern for the interests of the subject must always prevail over the interest of science and society" (World Medical Association's Declaration of Helsinki, Id. at 329); "I will maintain the utmost respect for human life, from the time of conception" (World Medical Association's Declaration of Geneva, Id. at 37).
  5. In 1994 the NIH Human Embryo Research Panel, while acknowledging that the human embryo deserves respect as "a developing form of human life," justified destructive research by claiming that the embryo does not have the status of a human person. The Panel relied here on the theory of Panel member Ronald Green, who argues that human beings can be excluded from "personhood" if, for example, recognizing them as "persons" would block too much useful research. By this approach, there is nothing inherent in any human being, of any age or condition, obliging us to respect that human being as a person. Thus the tension between research benefit and human rights is dissolved by circular reasoning: By this approach, a human whose rights stand in the way of medical benefit can be redefined as having no rights. See R. Green, "Toward a Copernican Revolution in Our Thinking About Life's Beginning and Life's End," 66 Soundings 152-73; cited in Final Report of the Human Embryo Research Panel (National Institutes of Health 1994) at 49.
  6. For further discussion of this point see the attached fact sheet, "'Spare' vs. 'Research' Embryos: A Meaningless Distinction," NCCB Secretariat for Pro-Life Activities, February 1995.
  7. The HHS interpretation, limiting the statutory ban to cover only the act of destruction itself, violates two principles of statutory construction. First, a statue must be construed to avoid rendering any of its words superfluous. Walters v. Metropolitan Educational Enterprises, 519 U.S. 202, 209-10 (1997); United States v. Menasche, 348 U.S. 528, 538-9 (1955). HHS's interpretation renders the words "research in which" superfluous. Second, when Congress chooses different language in proximate subsections of the same statute -- one narrow, the other broad -- the statute must be construed to give effect to those differences. Russello v. United States, 464 U.S. 16, 23 (1983), and cases cited therein.
  8. R. Weiss, "NIH Severs Ties With Researcher Who Experimented on Embryos," The Washington Post, January 9, 1997; Testimony of NIH Director Harold E. Varmus before the Subcommittee on Oversight and Investigations, House Commerce Committee, June 19, 1997.
  9. Letter of Donna E. Shalala to Rep. Christopher Smith, February 23, 1999.
  10. R. Weiss, "Can Scientists Bypass Stem Cells' Moral Minefield?", The Washington Post, December 14, 1998, A3.
  11. More information on this issue, including our congressional testimony of December 1998 and January 1999, is posted on the Web site of the National Conference of Catholic Bishops: www.nccbuscc.org/prolife/issues/bioethic. 


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