Source: http://old.usccb.org/prolife/issues/bioethic/cloning/test327.shtml
Timestamp: 2013-05-19 01:23:57
Document Index: 173189339

Matched Legal Cases: ['art 46', '§56', '§46', 'art 46', '§46', '§46']

USCCB - Pro-Life Activities - Testimony of Richard M. Doerflinger before the Subcommittee on Science, Technology and Space Senate Commerce, Science and Transportation Committee
Testimony of Richard M. Doerflinger before the Subcommittee on Science, Technology and Space Senate Commerce, Science and Transportation Committee
Subject: Cloning and Women's Health
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. The National 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 species.4 The National Institutes of Health (NIH), and President Clinton's National Bioethics Advisory Commission (NBAC), have acknowledged the same fact.5 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. The NAS 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 embryos.8 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 reproductive SCNT.12
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 sentence.
(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 depth here.16
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 all down:
(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 embryos. 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 this bill.19
(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 line 18).24 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 dignity.27 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 newborn stages. 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 cells.31 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 therapies).
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 parts.
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 29, 2003.
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 as well.
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 (www.stemcellresearch.org/pr/pr20030310.htm).
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 (http://cloninginformation.org/info/unsuccessful_mouse_therapy.htm).
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).