Copyright 1999 Federal News Service, Inc.
Federal News Service
JANUARY 26, 1999, TUESDAY
SECTION: IN THE NEWS
LENGTH:
3375 words
HEADLINE: PREPARED TESTIMONY OF
RICHARD
M. DOERFLINGER
COMMITTEE FOR PRO-LIFE ACTIVITIES
NATIONAL CONFERENCE OF
CATHOLIC BISHOPS
BEFORE THE SENATE APPROPRIATIONS COMMITTEE
SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES AND EDUCATION
SUBJECT -
LEGAL STATUS OF EMBRYONIC STEM CELL RESEARCH
BODY:
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
section 289g; 45 CFR ()46.201 If'.), 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.
1. 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? 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
Section 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 Section 289g-l(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 51 l(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.
2. 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 act 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 or 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.51 l(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. 51 l(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 Section 289g-l(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 Section 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 "terminate(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 dearly 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 Section 289g- l(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.
(Attachments: Reports of recent developments in alternatives to embryonic
stem cell research)
(NOTE: ATTACHMENTS ARE NOT TRANSMITTABLE) 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,
Al.
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 CA zygote is the beginning or a new human
being"); T.W. Sadlet, 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
19tion), p. 1 ("the male and female sex cells or gametes.., will unite at
fertilization to initiate the embryonic development of 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 Section 46.102(0); 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 Section
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 in Two 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.
END
LOAD-DATE: January 28, 1999