Legal Status of Embryonic Stem Cell Research

Testimony: Senate Appropriations Subcommittee on Labor, Health and Education

Hearing on Legal Status of Embryonic Stem Cell Research

January 26, 1999

Testimony of Richard M. Doerflinger on behalf of the Committee for Pro-Life Activities, National Conference of Catholic Bishops before the

Senate Appropriations Subcommittee on Labor, Health and Education

I am Richard M. Doerflinger, Associate Director for Policy Development at the Secretariat for Pro-Life Activities, National Conference of Catholic Bishops. I am grateful for the opportunity to present the Catholic bishops' concerns about efforts to justify the use of cells from deliberately destroyed human embryos in federally funded research.

I must begin by noting that a point I raised in my December 2 testimony before this subcommittee has received new support from recent events. I said then that the goals some wish to serve by killing human embryos for their stem cells can be achieved in other, morally acceptable ways. Even at that time, one of the advances cited by supporters as a future benefit of embryo research -- the ability to grow new blood vessels in the heart -- was already in clinical use in human patients with no need for embryonic cells.1 In the six weeks that have elapsed since then, however, two startling scientific breakthroughs have made it even more clear that destructive embryo research is unnecessary. The use of telomerase to promote regeneration of human tissues,2 and the new discovery that adult stem cells may be far more versatile than was once thought,3 offer the promise that embryonic stem cells may simply be irrelevant to future medical progress.

At the December 2 hearing, responding to our proposed list of promising alternatives to embryonic stem cell research, National Institutes of Health director Harold Varmus said that while adult stem cells can be obtained from bone marrow, cord blood and so on, they are of limited use because they cannot form other kinds of tissue such as nerve and skin. The most recent issue of Science suggests that this judgment was premature.

This subcommittee has now held three hearings on one narrow avenue of research -- precisely the avenue that creates the most obvious moral and legal problems -- to the exclusion of all other alternatives, even when those avenues may be more promising. I urge the subcomittee to expand its vision, to explore the alternatives that will advance medical progress and the well-being of patients without demeaning human dignity.

I would like to turn now to the legal memorandum prepared by the General Counsel of the Department of Health and Human Services ("HHS memo"). In its effort to find that federal funding of embryonic stem cell research is consistent with congressional intent, 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.

Specifically, the HHS memo ignores key aspects of the current appropriations rider on embryo research (Section 511 of the Labor/HHS appropriations bill for Fiscal Year 1999), statutory and regulatory provisions on live fetal research (42 USC .289g; 45 CFR .46.201 ff.), and statutory law on fetal tissue transplantation research (42 USC .289g-1).

Laws on Embryo Research and Live Fetal Research

HHS claims that current law on embryo research does not cover embryonic stem cell research, because the law protects only the embryo, which is an "organism" -- and a stem cell obtained by destroying an embryo is not an "organism." HHS even cites my December 2 testimony for the proposition that a stem cell is not an organism -- but the authors overlook other parts of my testimony. More importantly, they ignore two important aspects of current law.

Distorted definitions of "embryo" and "human being." First, as I noted on December 2, there is some uncertainty about the status of the cells that Dr. Gearhart of Johns Hopkins University has cultured from fetal germ cells after abortions. After being cultured, some of these stem cells may have a tendency to come back together and develop as an early embryo.4 Whether the formation of early embryos takes place in such a stem cell culture, and whether it can be prevented, is a scientific question. It demands a scientific answer, before federal funds are spent on the research -- because these funds by law cannot be used, even inadvertently, to create embryos which briefly develop and then die in culture. In other words, a stem cell is not an organism -- but the possibility must be explored that groups of stem cells may recongregate to form an entity that is, however briefly, a living organism.

HHS seeks to avoid this factual inquiry by inventing its own definition of an "embryo" -- a definition with no basis in science or law. Such an entity, HHS argues, could not be an embryo because, even if implanted in a womb, it could not become a "human being." The phrase "human being" is left undefined, but from the context it seems to refer solely to a liveborn infant.

Is "human being" intended here as a scientific term? Clearly not, since embryology textbooks tell us that in biological terms, the embryo is a human being.5 Even the NIH's Human Embryo Research Panel, whose recommendations for federal funding of embryo experiments were found morally unacceptable by President Clinton and Congress, called the early embryo "a developing form of human life."6

Is it, then, a legal term? No, since the phrase "human being" is not used in this part of federal law. Instead, since 1975, federal regulations have defined the human embryo, from implantation in the womb onward, as a "human subject" to be protected from harmful experiments, regardless of whether it is expected to survive to live birth.7 Current law on fetal research explicitly demands that a fetus to be aborted have the same protection as the fetus intended for live birth (42 USC .289g(b)).

Moreover, federal law on fetal tissue refers to the use of tissue from embryos and fetuses after a "spontaneous or induced abortion" or a stillbirth (42 USC .289g-1(g)). The HHS memo's definition would make this provision self-contradictory: A fetus that has spontaneously aborted did not have the ability to become what HHS calls a "human being," and so (by the HHS approach) cannot be called an "embryo" or "fetus" at all.

The current appropriations rider on embryo research is crystal clear. To determine whether an entity is an "embryo" we need only determine whether it is a living organism here and now (Section 511(b)). Section 511 says nothing about restricting this term to embryos that can be shown to have the "potential to develop" to live birth. In any case, testing an embryo's ability to become a born "human being" is clearly impossible once one has used such a definition to justify destroying that embryo in the laboratory.

HHS's strange and arbitrary digression on the phrase "human being" does not serve the goal of understanding federal law, but the very different goal of justifying harmful experiments. Some researchers have actually offered to engineer lethal defects in advance into the embryos they create and destroy with federal funds -- so that one could argue that these embryos would never become "human beings" and so are exempt from current law.8

Moreover, at this subcommittee's January 12 hearing, the theory was offered that unwanted or frozen embryos from fertility clinics can ethically be used for destructive research, because in any case they would not have produced a "human life." This did not refer to any defect in the embryos, but simply to the fact that parents have chosen not to let them survive. Such an approach makes a mockery of the current law, which was intended to protect such "spare" embryos from being harmed by the federal government regardless of what harm may be intended by others in the private sector. HHS would reduce current laws against harmful experiments on prenatal human life to this: Whenever someone wants to discard or destroy human embryos or fetuses instead of allowing them to survive, that very choice excludes them from the scope of the law's protection. Prenatal human beings would be protected by federal regulations only when they are in no need of such protection.

Misreading the embryo research rider. HHS's second error arises from a misreading of the appropriations rider. The HHS memo narrows its focus to the question whether a stem cell is an embryo, as though what had to be done to an embryo to obtain the stem cell is irrelevant. The implication here is that, so long as federal funds are not used for the specific of destroying a human embryo, such funds may be used for all subsequent research on the resulting cells and tissues. But this contradicts the plain words of the appropriations rider. It does indeed ban the use of federal funds for "the creation of a human embryo or embryos for research purposes" (apparently leaving open the possibility that federal funds might be used to do life-saving or therapeutic research on an embryo that was already created without federal funds)(Sec. 511(a)(1)). But the provision goes on to say that federal funds may not be used for "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death..." (Sec. 511(a)(2)). Clearly, if Congress wished to say merely that federal funds may not be used for destroying and discarding embryos, it knew how to say that; instead it used this broader phrase that is not used in the parallel clause on creating embryos.

How do we interpret the phrase "research in which"? A reasonable reading is that federal funds may not be used for research for the purpose of which human embryos were harmed or destroyed. Or, that federal funds may not be used for research that cannot be done without the prior harming or destroying of human embryos; or that such funds may not be used for research if such destruction is part of the researcher's protocol.9 Only one interpretation is impossible, because Congress went out of its way to exclude it -- the interpretation that this rider bans only the direct use of federal funds for the destructive harvesting of cells itself. That impossible interpretation is the one that HHS seems to accept.

Current Law on Fetal Tissue Research

HHS notes that "some" of the proposed research may implicate current law on fetal tissue research, citing Dr. Gearhart's experiment using fetal tissue from abortions as an example. Hinted at, but not explored by HHS, is the possibility that other proposed experiments -- those relying on the destruction of human embryos in the laboratory -- may also be governed by these provisions.

In fact, the law explicitly covers tissue obtained from a "human embryo or fetus" (42 USC .289g-1(g)). And since "fetus" is defined in this area of law to include any product of conception from implantation in the womb onward, the separate word "embryo" here can only refer to the unimplanted embryo -- the embryo in the laboratory. In that case, the word "abortion" in this provision should be construed to include the direct destruction of an embryo in the laboratory -- for otherwise the word "embryo" in the law would have no application whatever.

If this interpretation is correct -- if the use of tissue harvested from embryos in the laboratory is governed by current guidelines on fetal tissue research -- then such tissue cannot be used for federally funded tissue transplantation research. For such use would violate the guideline demanding that the "timing, method or procedures" for the abortion must not be altered "solely for the purposes of obtaining the tissue" for a federal research project (42 USC .289g-1 (b)(2)(A)(ii)). Clearly, the destructive method used to obtain stem cells from these embryos -- the use of immunosurgery to extract the inner cells -- is never used to discard "spare" embryos in fertility clinics, but is employed solely to obtain usable tissue for research.10

To be sure, this guideline's meaning is somewhat unclear, because it refers to influencing the timing and method for "terminat[ing] the pregnancy." Ordinarily such a phrase would not be used to describe the destruction of an embryo in the laboratory. However, one must recall what Congress was trying to prevent by enacting this provision. Members had learned of a procedure in Sweden, for example, in which the unborn child intended for abortion was killed by suctioning out its brain tissue for research on Parkinson's disease, and only afterward expelled from the womb.11 Here, the harvesting procedure was itself the "abortion," in the sense that it caused the death of the unborn child. Such abuses were to be prevented in federally funded research in the United States by this ban on altering the timing and method of abortion. The destructive harvesting of stem cells to cause an embryo's death, before it is discarded by a researcher or fertility clinic, provides a very close analogy to such abuses which Congress sought to prevent.

Indeed, this law clearly was intended to permit only the use of tissue that had been "obtained from a dead embryo or fetus" -- one that died of other causes before tissue was harvested (42 USC .289g-1(g)). Even in such cases, the guidelines were intended to prevent any influence by researchers upon the decision to abort. The idea of using tissue harvested in a way that itself destroys the embryo or fetus was not proposed by any member of Congress.12

Conclusion

In short, there is no clear support in any relevant provision of federal law and regulations for the HHS opinion on using stem cells from deliberately destroyed human embryos -- in fact, one can find much that is contrary to that opinion. The HHS memo ignores the explicit language of the current appropriations rider on embryo research; creates its own arbitrary and unsupported approach to definining a "human being"; and overlooks the possible relevance of current law on fetal tissue to the destructive harvesting of cells from human embryos.

In a broader view, it seems clear that all these laws and regulations enacted over the past 24 years were intended to ensure that the federal government never encourages the destruction of prenatal life as a source for research material. The HHS opinion would eviscerate this longstanding policy. Researchers who destroy human embryos would receive direct federal rewards for such destruction, since their lethal harvesting of tissue would make them uniquely eligible for federal grants for research on embryonic stem cells. The fact that such economic incentives would reward such destruction after the fact, instead of being bestowed in advance to pay directly for such destructive harvesting, is of no great significance.

If Congress wishes to insulate its funding of medical advances from the destruction of innocent life, there is a simple way to do just that. It should devote its funds to stem cell techniques and other promising avenues of research that in no way depend upon such killing. In that way our government will truly serve all the people, by showing that it will not promote the killing of one human being to serve another, or the development of treatments that millions of Americans would find it morally abhorrent to use.

Mr. Doerflinger's previous testimony on embryonic stem cell research (December 2, 1998)

Footnotes

1. See: "Technique grows new heart vessels," MSNBC Health, 11/9/98; "Injected Genes Help Grow Heart Bypasses," Washington Post, 11/10/98, A3.
2. C. Morales et al., "Absence of cancer-associated changes in human fibroblasts immortalized with telomerase," 21 Nature Genetics 115-8 (January 1999); see comments in Ruth Larson, "Scientists find new life for old cells," Washington Times, 12/29/98, A1.
3. C. Bjornson et al., "Turning Brain into Blood: A Hematopoietic Fate Adopted by Adult Neural Stem Cells in Vivo," 283 Science 534-7 (22 January 1999). See comments in: Evelyn Strauss, "Brain Stem Cells Show Their Potential," 283 Science 471 (22 January 1999); Paul Recer, "Patient's Cells May Grow New Organs," Associated Press, 1/21/99 ("If such a technique also worked in humans, embryos may not be needed for such research"); Nicholas Wade, "Cell Experiment Offers Hope for Tissue Repair," New York Times, 1/22/99, A21 (the technique avoids the "ethical considerations" arising from embryonic cells, as well as the "immune rejection problems" they can pose); Lee Bowman, "'Master cells' offer repair kits," Washington Times, 1/22/99, A9 ("it could mean that stem cells don't have to come from embryos to generate specialized cells").
4. In Dr. Gearhart's experiment, "embryoid bodies" had formed "complex structures" in culture "closely resembling an embryo during early development"; these structures "appear to recapitulate the normal developmental processes of early embryonic stages and promote the cell-cell interaction required for cell differentiation." M. Shamblott et al., "Derivation of pluripotent stem cells from cultured human primordial germ cells," 95 Proceedings of the National Academy of Sciences 13726-13731 (November 1998) at 13726, 13729. These remarks were cited in my December 2 testimony, at note 13.
5. See: Keith Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (W.B. Saunders 1998)(6th edition), p. 2 ("A zygote is the beginning of a new human being"); T.W. Sadler, Langman's Medical Embryology (Williams and Wilkins 1995)(7th edition), p. 3 ("The development of a human being begins with fertilization"); William J. Larsen, Human Embryology (Churchill Livingstone 1997)(2nd edition), p. 1 ("the male and female sex cells or gametes... will unite at fertilization to initiate the embryonic developmentof a new individual").
6. National Institutes of Health, Report of the Human Embryo Research Panel (November 1994), 2.
7. "Human subject," in turn, is defined as a "living individual" subjected to research (45 CFR .46.102(f)); Subpart B of Part 46 provides special protections for fetuses as human subjects. "Fetus" includes "the product of conception from the time of implantation" (45 CFR .46.203(c)). Through appropriations riders, Congress since 1995 has extended this same protection to all human embryos not previously protected as human subjects.
8. "The goal is to create a developing mass of mostly human cells that's crippled enough to prevent its development into a person, yet healthy enough during the first week of existence to produce the crucial 'stem cells' that scientists want to collect." Rick Weiss, "Can Scientists Bypass Stem Cells' Moral Minefield?", Washington Post, 12/14/98, A3 (emphasis added).
9. By these interpretations, both Dr. West's experiment (relying on the destructive harvesting of cells from embryos created by somatic cell nuclear transfer [cloning]) and Dr. Thomson's (relying on destructive harvesting of cells from "spare" embryos from fertility clinics) are barred from receiving federal funds. A mere bookkeeping distinction between funds used to destroy the embryo and funds used to work with the resultant cells is not sufficient.
10. Among the inadequacies in current compromise provisions on fetal tissue is the inclusion of the word "solely" here. It does not adversely affect the issue at hand, but could be used to justify federal collaboration with practitioners of the grotesque partial-birth abortion technique to obtain brain tissue for research purposes. Since the technique already involves killing a partly born child by suctioning out his or her brain tissue before completing delivery, it need not be altered "solely" to obtain usable tissue. Congress has repeatedly voted to make partial-birth abortion a federal crime, so presumably did not intend to state a preference for this procedure as a source of material for federally funded research.
11. O. Lindvall et al., "Human Fetal Dopamine Neurons Grafted Into the Striatum inTwo Patients With Severe Parkinson's Disease," 46 Archives of Neurology 615, 616 (June 1989).
12. The provision's chief sponsor said: "This issue... is not about abortion... This is about what happens after an abortion takes place: Will the tissue be discarded or will the tissue be used for research...?" (Rep. Waxman, Cong. Record, 3/10/93, H1131; emphasis added). Harvesting of embryonic stem cells is not done after the embryo is killed; it is precisely what kills the embryo.