Testimony of Richard M. Doerflinger before the
Subcommittee on Science, Technology and Space
Senate Commerce, Science and Transportation Committee
March 27, 2003
I am Richard M. Doerflinger, Deputy Director of the Secretariat for
Pro-Life Activities at the U.S. Conference of Catholic Bishops. I also
serve as Adjunct Fellow in Bioethics and Public Policy at the National
Catholic Bioethics Center. It is on behalf of the bishops' conference
that I wish to speak to you today about the moral challenge presented by
radically different congressional proposals on human cloning.
The sanctity and dignity of human life is a cornerstone of Catholic
moral reflection and social teaching. We believe a society can be
judged by the respect it shows for human life, especially in its most
vulnerable stages and conditions.
Human cloning is sometimes presented as a means for creating life, not
destroying it. Yet it shows disrespect toward human life in the very
act of generating it. Cloning completely divorces human reproduction
from the context of a loving union between man and woman, producing
children with no "parents" in the ordinary sense. Here human life does
not arise from an act of love, but is manufactured to predetermined
specifications. A developing human being is treated as an object, not
as an individual with his or her own identity and rights. As one group
of scientific and other experts advising the Holy See has written:
In the cloning process the basic relationships of the
human person are perverted: filiation, consanguinity, kinship,
parenthood. A woman can be the twin sister of her mother, lack a
biological father and be the daughter of her grandmother. In vitro
fertilization has already led to the confusion of parentage, but cloning
will mean the radical rupture of these bonds.1
Such moral concern transcends denominational bounds and has been
eloquently expressed by some of our country's most respected
philosophers and ethicists. Writes Professor Leon Kass of the
University of Chicago, now chairman of the President's Council on
Bioethics: Human cloning would... represent a giant step toward turning
begetting into making, procreation into manufacture (literally,
something "handmade")... [W]e here would be taking a major step into
making man himself simply another one of the man-made things.2
From the dehumanizing nature of this technique flow many disturbing
consequences. Because cloned humans are produced by a means more suited
to more primitive forms of life -- a means which involves no loving
relationship, no personal investment or responsibility for a new life,
but only laboratory technique -- they would be uniquely at risk of being
treated as "second-class" human beings.
The very scenarios often cited as justifications
for human cloning are actually symptoms
of the moral problem it creates. It has been said that cloning could
be used to create "copies" of illustrious people, to replace a deceased
loved one, or even to provide a source of spare tissues or organs for
the person whose genetic material was used for the procedure. In each
proposal we see a utilitarian view of human life, in which a human being
is treated as a means to someone else's ends instead of as a person
with his or her own inherent dignity. This same attitude lies at the
root of human slavery.
Let me be perfectly clear. In reality a cloned human being would not
be, in any sense, an "object" or a substandard human being. Whatever
the circumstances of his or her origin, he or she deserves to be treated
as a human person with an individual identity. But the depersonalized
technique of manufacture known as cloning disregards this dignity and
sets the stage for further exploitation. Cloning is not wrong because
cloned human beings lack human dignity -- it is wrong because they have
human dignity, and deserve to come into the world in ways that respect
this dignity. Each child has a right to be conceived and born as the
fruit of a loving union between husband and wife, to be loved and
accepted as a new and distinct individual.
Ironically, the most startling evidence of the dehumanizing aspects of
cloning is found in some proposals ostensibly aimed at preventing human
cloning. Some members of Congress favor legislation that would not ban
human cloning at all -- but would simply ban any effort to allow cloned
human beings to survive. In these proposals, researchers are allowed to
use cloning for the unlimited mass production of human embryos for
experimentation -- after which they are required to destroy them.
Enactment of such a proposal would mark the first time in history that
the U.S. government defined a class of human beings that it is a crime
not to destroy.
Specifically I have been asked to comment on the two pending federal
bills now offered as a response to human cloning: the Hatch/Feinstein
"Human Cloning Ban and Stem Cell Research Protection Act" (S. 303), and
the Brownback/Landrieu "Human Cloning Prohibition Act" (S. 245).
Let me begin with the bill that is, in my view, offered under false
pretenses – the bill that, despite its title, is not a ban on human
cloning at all.
S. 303 (Hatch/Feinstein)
This bill is gravely deficient in at least eight ways.
1. It does not, in fact, ban human cloning at all.
Academy of Sciences (NAS) has defined "cloning" as the production of "an
organism that has the same nuclear genome as another organism."3
As Congress has formally acknowledged since 1996, the early embryo
produced by fertilization or cloning is an organism of the human
The National Institutes of Health (NIH), and President Clinton's
National Bioethics Advisory Commission (NBAC), have acknowledged the
To produce that embryo – using, for example, the somatic cell nuclear
transfer procedure used to make Dolly the sheep – is to conduct human
cloning, whatever else one may plan to do with that embryo afterwards. This is scientific fact, not ethics or politics. It was, in fact, a
unanimous point of agreement in the recent report on cloning by the
President's Council on Bioethics, whose members otherwise disagreed
sharply on moral and policy issues.6
S. 303 does nothing whatever to ban the use of the cloning procedure to create human embryos, for any
purpose (or even to restrict someone's ability to create them for no discernible purpose at all).
2. What it does ban is "embryo transfer," a distinct procedure
already in use by fertility clinics across the world for many years; and
this creates serious legal and enforcement problems.
defines "embryo transfer" as "the introduction of a preimplantation
embryo into the uterus for growth and development."7
S. 303 bans this
procedure, if it involves an embryo produced earlier by cloning (page 2 lines 10-13). This has certain consequences:
(A) The bill's penalties are directed not against irresponsible
researchers engaged in human cloning, but against those engaged in
implanting or attempting to implant the cloned embryo in a womb –
presumably including the woman herself. (If the penalty did not
apply to the woman, of course, this would create an enormous loophole –
the law could be completely evaded by having the woman herself conduct
the embryo transfer, a realistic possibility if she has any training as a
fertility doctor or technician.)
(B) Such a law is inherently almost impossible to enforce,
because at this stage of embryonic development there is no reliable way
for law enforcement to distinguish cloned embryos from fertilized
Even to initiate such scrutiny would require delaying embryo transfer
until the results of all relevant tests were obtained, at which time the
embryo in question (whether cloned or fertilized) would most likely be
dead. In this context it is important to note that while cloned animal
embryos seem much more likely to suffer from serious problems of
disorderly gene expression than embryos created by union of sperm and
egg, these problems are not detectable by any prenatal diagnostic test
in current use.9
(C) The bill recognizes this problem, and tries to resolve it
by forbidding researchers to conduct human cloning research at the same
laboratory where "assisted reproduction"occurs (page 10 lines 19-24).
But of course this begs the question, which is: How do you tell which of
the two is being done at any given time? And how would you create a
closed system to prevent cloned embryos from being brought from one
laboratory to the one next door?10
3. This bill allows cloning research that will facilitate what its
sponsors claim to oppose – that is, cloning to produce born children.
Again, this is widely acknowledged by experts who support cloning for
research in general and S. 303 in particular. For example, researchers
and ethicists who support
cloning for research purposes (which
they call CRNT for "cell replacement through nuclear transfer") admit
that "the techniques developed in CRNT research can prepare the way
scientifically and technically for efforts at reproductive cloning."11
Similarly, the ethics committee of the American Society for
Reproductive Medicine (ASRM), which supports S. 303, has stated
regarding human cloning for research purposes:
If undertaken, the development of SCNT [somatic cell nuclear transfer]
for such therapeutic purposes, in which embryos are not transferred for
pregnancy, is likely to produce knowledge that could be used to achieve
To be sure, this does not create an intractable conflict for ASRM itself in terms of supporting S. 303, because ASRM does not
support a permanent ban on (even) "reproductive" cloning.13
The conflict is between the public statements of the bill's supporters
in Congress, and the real-world impact of the legislation they support.
4. The bill allows exporting of cloned embryos to facilitate violations of other countries' laws.
Incredibly, the bill forbids exporting of cloned embryos
("unfertilized blastocysts") to a foreign country only "if such country
does not prohibit human cloning" (page 3 lines 19-21). Under S. 303,
cloned embryos can
be exported to foreign countries that do
prohibit "human cloning" as defined by the bill, where they will be used in illegal
efforts to initiate pregnancies with cloned embryos. Thus the bill
would facilitate abroad what it purports to make illegal here.
5. Through careless and incoherent drafting, the bill potentially restricts activities that are not human cloning.
To mention only a few:
(A) "human somatic cell" - defined to include "any
human cell other than a haploid germ cell" (page 2 lines 14-16), so that
it includes even the one-celled embryo. It will be a crime to implant
in a uterus any embryo produced by transferring the nucleus from one
single-celled embryo into another embryo or an unfertilized egg. By
most definitions this is not cloning; it is a nuclear transfer technique
used in some fertility clinics in an effort to circumvent mitochondrial
disease (by replacing the defective mitochondrial DNA found in the
protoplasm of the woman's own egg), to allow women with this disease to
have healthy children. S. 303 bans this nuclear transfer procedure
itself (page 9 line 23 to page 10 line 2), and also bans transferring
any of these repaired embryos to a woman's womb (page 3 lines 13-14, in
light of the definitions on page 2).
(B) "unfertilized blastocyst" (page 3 lines 3-9) - This is
apparently intended as a demeaning reference to cloned embryos, but the
word "blastocyst" is inaccurately used here to refer to the one-celled
embryo initially produced by cloning, and even to the 14-day-old cloned
embryo (whose further survival is made illegal by S. 303).14
More broadly, "unfertilized blastocyst" is defined as any "intact
cellular structure" produced by somatic cell nuclear transfer, so the
bill bans transferring this product to a woman's womb whether it is an embryo or not.
For example, if researchers develop a way to modify the egg or the
somatic cell in advance, so that the initial product of this technique
is not a living organism but a culture of stem cells (as some
researchers say they may be able to do), this would be covered by the
ban. Placing, say, endothelial stem cells produced by this hypothetical
technique into a woman's womb to help heal her endometrial tissue would
not be forbidden by any moral principle of which I am aware – but under
a literal reading of this bill, it could provoke a ten-year prison
(C) "the functional equivalent of a uterus" (page 2 line 13) -
This odd phrase is not defined, leaving room for much confusion. For
example, S. 303's prime sponsor has repeatedly said there is no such
thing as the functional equivalent of a uterus, because the function of a
uterus is to turn the new embryo into a "human life" and no artificial
environment can fulfill this task:
After many conversations with scientists, ethicists, patient
advocates, and religious leaders and many hours of thought, reflection,
and prayer, I reached the conclusion that human life does not begin in
the petri dish. I believe that human life requires and begins in a
mother's nurturing womb.15
If, on the other hand, the phrase "functional equivalent" is to have any
application, one can only guess how effective an artificial environment
must be to qualify as a "functional equivalent" of a uterus. Certainly
a Petri dish itself does not qualify, for then even cloning for
research (which requires developing the cloned embryo to the blastocyst
stage in that dish) would be banned. Perhaps a "functional equivalent"
is an environment that could sustain the cloned embryo to live birth,
because any womb that fails to do so would not fulfill the usual
"function" of a womb. In that case, one may transfer the embryo to any
artificial environment that would fall short of this function to any
extent – in other words, at present one may transfer the embryo to any
and all artificial environments. This will be important in the likely
event (discussed below) that the bill's "14-day rule" for maintaining a
cloned embryo is later changed.
6. The bill erects a Potemkin village, a mere facade, of protection
against research risks for human subjects involved in cloning research.
Title II of the bill (page 8 ff.) claims to expand current regulations
on federally funded research involving human subjects (Subpart A of 45
CFR Part 46), so they will now apply to all "research involving nuclear
transplantation" (even if privately funded). This one-sentence
expansion of federal regulations into the private sphere raises a number
of serious legal and jurisdictional issues that cannot be explored in
However, assuming that the goal here is to place real ethical limits on
human cloning for biomedical research, that goal is not met at all.
Three distinct classes of humans may be involved in cloning research –
the embryos created by cloning, the women solicited for their eggs, and
the patients who donate body cells in the hope of receiving a
genetically compatible stem cell treatment – and this Title lets them
(A) There is no ethical limit on what one may do to cloned embryos outside the womb
because there are no such limits in federal human subjects regulations.
To be sure, there are limits – in fact, there is an absolute ban – on
federally funded research that harms or destroys human embryos,
specifically including cloned embryos.17
However, that is statutory language, not part of the Code of Federal
Regulations, so it will not apply. This is, of course, by design – if
S. 303 did extend Congress's policy on federally funded human embryo
research to the private sector, the research favored by supporters of S.
303 would be illegal. This raises a very odd contradiction: Congress
will enshrine as permanent law whatever regulatory language happens to
have been written by the staff of the Executive branch up to the moment
when this bill is enacted (page 9 lines 15-22) – but Congress will
ignore its own statutory language that has been duly enacted and signed
into law by Democratic and Republican presidents every year for the past
six years, although it is the only federal policy that directly relates to the issue at hand.
The only relevant provision that S. 303 itself provides on this point is in direct contradiction
to current federal policy on embryo research – that is, the provision
requiring all cloned embryos to be destroyed at the age of 14 days (page
10 lines 3-7). In federally funded projects, of course, Congress forbids
researchers to destroy or harm cloned human embryos.
(B) Title II places no ethical limits on what may be done
to human subjects who may be the recipients of stem cells from cloned
The bill's expansion of federal human subjects regulations
into the private sector applies only to "research involving nuclear
transplantation" (that is, the act of creating cloned embryos). Since
1999, the law on federally funded research involving human embryos has
been construed not
to apply to activities using stem cells derived from those embryos.18
The sponsors of S. 303 certainly agree with this legal opinion, which
allows the federal government to fund embryonic stem cell research even
when it cannot fund the research in which the embryos are created or
destroyed. S. 303 actually reinforces this distinction, by explicitly
defining the "unfertilized blastocyst" produced by nuclear
transplantation to exclude
any stem cells derived from this
blastocyst (page 3 lines 6-9). So the considerable risks involved in
placing embryonic stem cells from cloned embryos into patients – an
activity that in animals can produce tissue rejection,
overproliferation, and tumor formation – are completely unaddressed by
(C) Title II places only the vaguest and most inadequate limits on what can be done to women selected as "donors" of eggs.
Again, current federal regulations contain no
specific guidance on the standards for donating eggs to make embryos, for the obvious reason that it has been a de facto
federal policy for 23 years not
to fund human in vitro fertilization research. The regulations contain
some vague and general guidelines regarding risks, informed consent,
and approval by institutional review boards (IRBs). But egg donation
for the purpose of creating embryos for research is one of those
practices that the entire IRB system is supposedly designed to
discourage – that is, the practice of involving human subjects in
research that imposes significant risks upon them but can be of no
benefit to them as individuals. S. 303 wrongly seems to assume that a
signature on a consent form (page 10 lines 9-13) and compensation for
"time or inconvenience" (page 9 lines 12-14) will justify researchers in
subjecting women to serious risks, including a potentially increased
risk of ovarian cancer, in the name of progress. This approach ignores
what Professor Alta Charo and the other members of the National
Bioethics Advisory Commission warned in 2001, when they issued a report
on the inadequacy
of current safeguards against such exploitation of human subjects:
No matter what potential benefit is offered to individual
participants or society at large, the possibility of benefit from one
element of a study should not be used to justify otherwise unacceptable
elements... In our view, IRBs should appreciate that for some
components of a study, participants might incur risks with no personal
potential benefit... For these elements, there should be some limitation on the amount of social and physical risk that can be imposed, regardless of the participants' willingness to participate or the monetary (or other) enticement being offered.20
This NBAC report also called attention to serious deficiencies in the
IRB system itself as it currently exists, including the conflicts of
interest that often allow IRBs to represent the interests of their own
research institution rather than those of vulnerable human subjects:
In recent years, increasing strains on the system have undermined the practice of independent review. IRBs are overburdened by the volume of research coming before them, a strain that is compounded by concerns about training of IRB members and possible conflicts of interest.
In addition, the constantly changing nature of research challenges
existing notions about what constitutes risks and potential benefits....
Today, investigators and IRBs are rightly confused over issues as basic as which areas of inquiry should be reviewed and who constitutes a human participant.21
The Commission even noted with concern that "there are no clear criteria
for IRBs to use in judging whether the risks of research are reasonable
in terms of what might be gained by the individual or society."22
It is difficult to reconcile this pointed and well-deserved critique
of the current system with the enthusiastic endorsement given to it by
Professor Charo in her testimony before this subcommittee today. How
can this new, complex and ethically controversial field of human cloning
research – research that may endanger women and desperately sick
patients as well as embryonic humans -- be adequately addressed by a
system so often found incapable even of meeting its current obligations
to protect human subjects in traditional medical research?
(D) Title II's reference to FDA oversight is confusing, unpersuasive and incoherent.
At an earlier hearing before the House of Representatives, members of
Congress of both parties found the claim of FDA jurisdiction over human
cloning to be unpersuasive.23
At the very least, any such claim must address a very basic threshold
question. In order to claim that FDA regulations can be applied to
research involving "nuclear transplantation" (page 9 lines 19-20), what
kind of entity does the cloned embryo have to be? These regulations do
not cover medical techniques or procedures as such, but relate to
"products" such as "foods, including dietary supplements, that bear a
nutrient content claim or a health claim, infant formulas, food and
color additives, drugs for human use, medical devices for human use,
biological products for human use, and electronic products" (21 CFR
§56.101(a)). Assuming that the cloned embryo is not a food additive or a
drug, he or she must be a "biological product" – a commodity to be
tested for its dangers to others.
Not only is this a false,
demeaning and dehumanizing label for a fellow member of the human
species, but it directly contradicts the sponsors' alleged rationale for
banning "reproductive" cloning – that is, the risks to the child,
including the massive risk of miscarriage and birth defects. One and
the same entity cannot be the innocent victim
of the experiment, and at the same time be the dangerous "biological product" from whom others
must be protected by the Food and Drug Administration.
(E) The bill's policy on research involving the cloned child in the womb raises especially disturbing moral and legal issues.
While current federal regulations on protection of human subjects do
not cover the embryo outside the womb, they do protect the embryo and
fetus implanted in the womb as well as the pregnant woman (45 CFR
§§46.201 to 46.207). However, S. 303 refuses to expand to the private
sector these specific protections for the cloned unborn child or the
woman who may bear him or her -- for these are found in Subpart B of
Part 46, and Title II expands the reach only of Subpart A (see page 9
Researchers who were not themselves involved in the illegal act of
transferring the cloned embryo to a uterus would surely be interested in
observing any special risks or other developments arising from the
first human clonal pregnancy. Apparently S. 303 refuses to expand
protections for pregnant women and their cloned unborn children in order
to avoid a direct contradiction: The existing federal regulations
forbid federally funded researchers to impose significant risks of harm
and death on the unborn human subject (see 45 CFR §46.204), but sponsors
of S. 303 want to ban "maintaining" the cloned unborn child for more
than 14 days in any
environment except a deep freezer (page 10
lines 3-7). It seems this latter requirement can only be obeyed by
forcing an abortion about one week after implantation (which usually
occurs about six days after the embryo is formed). This raises a moral
and perhaps even constitutional nightmare, and directly contradicts
federal policies that have sought to protect fetuses and pregnant women
from harmful research since 1975.
7. Most generally, this bill's policy on the human embryo ratifies
one gravely demeaning view that lies at an extreme end of the spectrum
in our divided and pluralistic society: The embryo as commodity, as
nothing more than disposable property to be manufactured and discarded
to suit the desires of others.
It is important to note this,
because supporters of cloning for research have wrongly applied this
"pluralistic society" argument against the Brownback bill.25
The fact is that a complete ban on cloning, already approved by a
number of states as well as foreign countries, can be supported and is
supported by Americans with a wide array of views on the moral status of
the embryo – those who, like myself, hold that each and every member of
the human species deserves to be protected as a human person; those
who, like some ethicists, columnists and others, hold that the embryo
(if not a "full" person) is at least a developing human life that
deserves respect and should not be created solely to be destroyed;26
and those who are agnostic on the status of the embryo but recognize
that a complete ban on cloning is the only effective and enforceable way
to prevent cloning for babymaking as well as further assaults on human
By contrast, the enactment of S. 303 would assume, and seek to
promote, a national consensus that the cloned embryo has no moral status
whatever, or has the status of a being whose survival is an active
threat to the public good. No other view is consistent with a policy
that this embryo may be created at will, but that government can mandate
its destruction at a certain stage.
Under S. 303 it would be a federal offense to let such an embryo
survive, or to show this fellow human being any degree of respect. Dr.
Charles Krauthammer has observed:
Creating a human embryo just so it can be used and then
destroyed undermines the very foundation of the moral prudence that
informs the entire enterprise of genetic research: the idea that, while a
human embryo may not be a person, it is not nothing. Because if it is
nothing, then everything is permitted. And if everything is permitted,
then there are no fences, no safeguards, no bottom.28
I am confident that Congress will not enact such a gravely immoral policy and that President Bush would refuse to sign it.
8. Finally, this bill as written cannot achieve its stated objective
of advancing therapies, and the biotechnology lobby has already moved on
to broader policies for exploiting cloned humans at the fetal and
The sponsors of this bill have apparently failed to
notice that only two animal studies have claimed to show any
"therapeutic" benefits from cloning for research. One study, seeking to
provide kidney tissue for cows, found it necessary to develop the
cloned cow embryos to the fetal
stage so they could be aborted for their partly formed kidney tissue.29
The other, seeking to remedy an immune deficiency in mice, found it necessary to produce a newborn
mouse whose adult
stem cells could be transplanted into the original mouse.30
These and other studies have found embryonic
stem cells to be enormously difficult to culture, to control, and to
develop into usable cells that will integrate with the host animals'
cells; they have found these cells to have a disturbing tendency to form
lethal tumors in recipients' bodies; and they have found that even
embryonic cells from cloning can be rejected by the recipients' bodies,
perhaps because of inherent differences between embryonic and adult
Reading the handwriting on the wall, state biotechnology alliances
have conducted simultaneous campaigns in several states to pass
legislation authorizing research involving the derivation and use of human
embryonic stem cells, human embryonic germ cells, and human adult stem
cells from any source, including somatic cell nuclear transplantation.32
Embryonic germ cells, of course, are harvested at the fetal stage (at
around 8 weeks' gestation), while adult stem cells are harvested from
infants and children. In this new generation of cloning legislation,
the old distinction between "therapeutic" cloning and "reproductive"
cloning has been obliterated: Researchers will conduct "reproductive"
cloning (developing cloned embryos to at least the fetal stage) to
achieve "therapeutic" cloning (producing usable stem cells for supposed
At present S. 303 punishes efforts to maintain the cloned embryo past the 14th
day. But this is an arbitrary limit, and Congress will be hard pressed to find a principled
reason not to extend this to 20 days, or 30, or 100, if (as now seems
more than likely) researchers report that such an extension is necessary
to fulfill the "promise" of "therapeutic cloning." In the laboratory
of the states, this broader agenda has already been launched.
S. 245 (Brownback/Landrieu)
By contrast, S. 245 has none of the serious problems outlined above. Very briefly, this bill:
1. Does ban human cloning, as that is accurately and scientifically defined.
2. Imposes its penalties on irresponsible researchers, not on vulnerable
women, and avoids the moral, legal and constitutional problems raised
by efforts to "ban" pregnancy and birth.
3. Effectively attacks the threat of "reproductive cloning" at its root, by preventing the production of cloned human embryos.
4. Bans shipping, receiving or importing of cloned human embryos for any
purpose, preventing any collusion by the U.S. government with those who
wish to violate other countries' laws against cloning.
5. Is carefully crafted to avoid interference with any activity other than human cloning.
6. Directly protects all humans who would be harmed by the practice of
human cloning (embryos, patients, and women who might be exploited for
their eggs), by banning the practice for any purpose.
7. Respects the diversity of American views on the human embryo, by
enacting only those provisions necessary to ban human cloning and
leaving other research (including embryonic stem cell research that does
not involve cloning) to be addressed by other proposals.
8. Prevents future "slippery slopes" that would require us to demean and
exploit ever wider classes of our fellow humans as sources of body
This is a case in which how
we achieve an important goal is at
least as important as whether we achieve it. We should ban human cloning
-- by banning the use of the cloning procedure to create new developing
humans in the first place, as in the Brownback/Landrieu cloning ban (S.
245). Legislation which allows the practice, and then seeks to
dehumanize and destroy the humans thus produced so we can pretend we
have banned cloning, is worse than doing nothing. I urge Congress to
oppose S. 303, and to approve the genuine ban on human cloning offered
by S. 245.
1. Reflections from the Pontifical Academy for Life, "Human Cloning Is Immoral" (July 9, 1997), in The Pope Speaks
, vol. 43, no. 1 (January/February 1998), p. 29. Also see: Congregation for the Doctrine of the Faith, Donum Vitae
(Instruction on Respect for Human Life in its Origin and on the Dignity of Procreation)(March 10, 1987), I.6 and II.B.
2. Leon R. Kass, "The Wisdom of Repugnance," in The New Republic
, June 2, 1997, p. 23.
3. National Academy of Sciences, Scientific and Medical Aspects of Human Reproductive Cloning
(National Academy Press 2002), p. E-4.
4. See the Dickey amendment enacted as part of the
annual Labor/HHS appropriations bills since 1996: "'human embryo or
embryos' includes any organism, not protected as a human subject under
45 CFR 46 as of the date of the enactment of this Act, that is derived
by fertilization, parthenogenesis, cloning, or any other means from one
or more human gametes or human diploid cells." The current version of
this amendment is Sec. 510 of P.L. 108-7, the Omnibus Appropriations Act
of 2003 (enacted Feb. 20, 2003).
5. NBAC defined "embryo" as "the developing organism
from the time of fertilization until significant differentiation has
occurred..." NBAC, Cloning Human Beings
(Rockville, MD: June
1997), Vol. I, p. A-2. This term encompasses the cloned embryo:"The
Commission began its discussions fully recognizing that any effort in
humans to transfer a somatic cell nucleus into an enucleated egg
involves the creation of an embryo, with the apparent potential to be
implanted in utero
and developed to term." Id., p. 3.
Similarly, the NIH defines "embryo" as follows: "In humans, the
developing organism from the time of fertilization until the end of the
eighth week of gestation." NIH, Stem Cells: Scientific Progress and Future Research Directions
(U.S. Department of Health and Human Services: June 2001), p. F-3.
6. The President's Council on Bioethics, Human Cloning and Human Dignity
(Washington, D.C.: July 2002), pp. 54-55.
7. NAS, note 3 supra, p. A-2.
8. See Written Statement of Daniel J. Bryant,
Assistant Attorney General, before the Subcommittee on Criminal Justice,
Drug Policy and Human Resources of the House Committee on Government
Reform, May 15, 2002 (www.house.gov/weldon/issues/doj.htm).
9. For example, see: Testimony of Dr. Mark E.
Westhusin before the House Energy and Commerce Subcommittee on Oversight
and Investigations, March 28, 2001; R. Jaenisch and I. Wilmut, "Don't
Clone Humans!", 291 Science (30 March 2001), p. 2552.
10. This provision illustrates the truth of the
Justice Department's testimony: One cannot enforce this ban without
imposing new and unprecedented restrictions on fertility procedures
already widely practiced in this country. For the provision is
double-edged: Its text says that one may not conduct cloning research in
a laboratory where eggs are subjected to assisted reproduction
procedures (page 10 lines 21-24); but its heading calls for "separation
of in vitro fertilization laboratories" from locations where cloning
research is conducted (page 10 lines 19-21). If a laboratory started
conducting cloning research first, in vitro fertilization is banned
there. This would be the first federal law to restrict where one may
establish a private fertility clinic.
11. Lanza et al., "The ethical validity of using nuclear transfer in human transplantation," 284 (24) Journal of the American Medical Association
(Dec. 27, 2000), pp. 3175-9 at p. 3178.
12. Ethics Committee of the American Society for Reproductive Medicine, "Human somatic cell nuclear transfer (cloning)," 74 (5) Fertility and Sterility
(Nov. 2000), pp. 873-6 at p. 873.
13. "There is not yet clear consensus that
reproductive SCNT in cases of infertility serves a compelling need...
Nor is there clear consensus on a compelling need to bar the technique."
Id., p. 875. ASRM can support S. 303, consistent with its own policy,
because the bill's authorization for research cloning will help make
its ban on "reproductive cloning" a temporary one.
14. In embryology the "blastocyst" is the embryo from four to around seven days old.
15. Statement of Senator Orrin Hatch before the
Senate Commerce Subcommittee on Science, Technology and Space, January
16. One threshold question would be: What activities
involving nuclear transplantation will count as "research"? The
question is now easily answered operationally in the case of federally
funded research, because each research proposal must be submitted to the
federal government in the form of a grant request. Potential grantees
have an interest in arguing that what they wish to do is research. Is
any current federal definition of "research" clear and specific enough
to be applied to those conducting privately funded activities, even when
the researchers will have an interest in denying
that they are
conducting "research" (so they can exempt themselves from this Title of
the bill)? Does this bill really intend to say that if a project is not
research - if cloning is used to produce human embryos simply for
sport, or in order to "farm" them for strictly commercial purposes, such
activity is exempt from these restrictions?
17. See the Dickey amendment, note 4 supra.
18. HHS General Counsel Harriet S. Rabb, Memorandum
to NIH Director Harold Varmus on "Federal Funding for Research Involving
Human Pluripotent Stem Cells," Jan. 15, 1999.
19. The NIH notes: "The potential disadvantages of
the use of human ES cells for transplant therapy include the propensity
of undifferentiated ES cells to induce the formation of tumors
(teratomas)." NIH, note 5 supra, p. 17. In short, "undifferentiated
embryonic stem cells are not considered as suitable for transplantation
due to the risk of unregulated growth." Id., p. 97. Also see S.
Wakitani et al., "Embryonic stem cells injected into the mouse knee
joint form teratomas and subsequently destroy the joint," 42 Rheumatology
(2003), pp. 162-5. And recent studies indicate that even stem cells
from cloned embryos, supposedly a genetic match, may be rejected by
recipients' bodies. See Y.L. Tsai et al., "Plasticity, Niches, and the
Use of Stem Cells," 2 Developmental Cell
(June 2002), pp. 707-712 at p. 710.
20. NBAC, Ethical and Policy Issues in Research Involving Human Participants
(Bethesda, Maryland: August 2001), p. iii (emphasis added).
21. Id. p. iii, vii (emphasis added). For an
extreme recent case of "conflict of interest," see the findings of
Maryland's highest court in Grimes v. Kennedy Krieger Institute
782 A.2d 807 (Md. 2001). The court found that the IRB at Johns Hopkins
University had "abdicated" its responsibility to protect children from
research risks, and had shown itself "willing to aid researchers in
getting around federal regulations designed to protect children used as
subjects in nontherapeutic research" (that is, research that would not
benefit those particular children). No one who has read this decision
will want to entrust all ethically controversial research decisions
solely to IRBs.
22. Id., p. xvi (emphasis added).
23. Hearing before the House Energy and Commerce
Subcommittee on Oversight and Investigations, Marcy 28, 2001. The
opening remarks by committee chairman Rep. Billy Tauzin were
characteristic of members' reactions: "The FDA argues these old federal
laws regulating new drugs cover a human cell or a human fetus. I
frankly do not find it obvious that a human fetus is a drug."
24. Transferring such an embryo to the womb is of
course illegal under S. 303, and those who perform this activity would
be prosecuted and imprisoned. If the woman is not herself punished, she
will still be potentially available as a subject for observational
research on human clonal pregnancies (research conducted by researchers
other than the original felons). If she, too, is imprisoned, however,
she might be protected by the federal regulations providing additional
protections for prisoners subjected to research (Subpart C, 45 CFR
§§46.301 to 306) -- if not for the fact that S. 303 excludes Subpart C
25. See Testimony by Dr. Paul Berg ("We take
considerable pride in being a pluralistic society"), Dr. Harold Varmus
("(W)ho has such moral standing that they [sic] would impose on our
multi-ethnic, pluralistic society an ethical standard that only a
minority would endorse?"); and Dr. Thomas Murray ("Respecting the
diversity of beliefs about families, about women, men, children -- and
embryos -- honors our most noble traditions") before the Senate
Judiciary Committee, March 19, 2003.
26. "We can debate all day whether an embryo is or
isn't a person. But it is unquestionably human life, complete with its
own unique set of human genes that inform and drive its own development.
The idea of the manufacture of such a magnificent thing as a human life
purely for the purpose of conducting research is grotesque, at best."
Editorial, "Embryo Research Is Inhuman," Chicago Sun-Times
, October 10, 1994, p. 25.
27. See "Statement of Dr. Krauthammer," in The President's Council on Bioethics, note 6 supra, pp. 277-285.
28. Id., p. 285.
29. R. Lanza et al., "Generation of histocompatible tissues using nuclear transplantation," 20 Nature Biotechnology
(July 2002), pp. 689-96. The authors wrote: "Because the cloned cells
were derived from early-stage fetuses, this approach is not an example
of therapeutic cloning and would not be undertaken in humans." Id, p.
689. Now lead researcher Robert Lanza has reversed his stand, insisting
that this study is indeed a model for "therapeutic cloning." See Do No
Harm: The Coalition for Research Ethics, "Reality Check: Proof of
'Therapeutic' Cloning?", March 10, 2003
30. W. Rideout et al., "Correction of a Genetic
Defect by Nuclear Transplantation and Combined Cell and Gene Therapy,"
109 Cell (April 15, 2002), pp. 17-27. For a critique of this study see
Americans to Ban Cloning, "Why the 'Successful' Mouse 'Therapeutic'
Cloning Really Didn't Work," April 2002
31. See note 19 supra.
32. Such language was enacted into law in California
in September 2002. Virtually identical language has been proposed in:
Illinois (HB 3589, introduced February 2003), Maryland (HB 482,
introduced February 2003), New Jersey (S. 1909, introduced September
2002), New York (A. 1819, introduced January 2003), Pennsylvania (HB
422, introduced February 2003), Texas (SB 1034, introduced March 2003),
Vermont (H. 326, introduced in 2003), and Washington (SB 5466, approved
by committee March 2003).