Opening Remarks

• The Honorable Mary L. Landrieu

  U.S. Senator

  Louisiana
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  Opening Remarks

  The Honorable Mary L. Landrieu

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Testimony

• Ms. Lynne Millican
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  Testimony

  Ms. Lynne Millican

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• Dr. John Bruchalski
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  Testimony

  Dr. John Bruchalski

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• Dr. Maria del Carmen Bustillo
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  Testimony

  Dr. Maria del Carmen Bustillo

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Witness Panel 2

• Mr. Richard Doerflinger
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  Witness Panel 2

  Mr. Richard Doerflinger

  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. 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. 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.” As Congress has formally acknowledged since 1996, the early embryo produced by fertilization or cloning is an organism of the human species. The National Institutes of Health (NIH), and President Clinton’s National Bioethics Advisory Commission (NBAC), have acknowledged the same fact. 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. 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.” 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. 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. (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? 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.” 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. 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. 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). 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. 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. 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. 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. 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. (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. 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. 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.” 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. 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). 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. 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; 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. 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. 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. 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. 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. 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. 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.

• Ms. R. Alta Charo
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  Witness Panel 2

  Ms. R. Alta Charo

  Mr. Chairman and members of the Committee, My name is Alta Charo, and I am a professor of law and bioethics at the University of Wisconsin. Thank you for this opportunity to discuss with you a shared goal, the goal of preventing irresponsible experimentation that involves the use of somatic cell nuclear transfer (that is, cloning) to produce a live-born child. Because cloning is not, and may well never be, a safe method for conceiving children, there is virtually perfect consensus that such attempts ought to be discouraged. The federal Food and Drug Administration has already taken a first and definitive step toward this goal, by announcing that it views attempts to use somatic cell nuclear transfer tp create a child to fall within the scope of its regulatory authority, and by further announcing that this technique may not legally be used in the United States for this purpose. While scholars may argue about the precise statutory language behind this action, it is a fact that FDA has already enforced its authority, by investigating alleged attempts to use cloning to produce a live-born child, and by issuing warning letters to those suspected of being most likely to try this unsafe experiment. The small number of eccentric scientists who claim an interest in pursuing this effort have reacted by moving their activities to other countries, and by acknowledging in the press that they understand that cloning to produce a live-born child is illegal in the United States, thus confirming the effectiveness of FDA’s enforcement efforts. The Congress has repeatedly demonstrated its interest in bolstering FDA’s already successful efforts, whether by re-affirming and particularizing its jurisdiction over this activity or by banning the practice directly by legislative action. In each effort, however, Congress has become bogged down in a related but distinctly separate debate concerning the use of cloning for research or therapeutic purposes. I urge you today to separate these two debates, both to protect the valuable scientific and medical advances that may emerge from non-reproductive cloning research, and to pave the way to effective action to discourage attempts to use this technique to produce children. S. 303, introduced and co-sponsored in the Senate by members such as Senators Hatch, Feinstein, Kennedy, and Specter would prohibit all efforts to use cloning to produce children. Stiff penalties are applied to those who would dare to make such an attempt. The simple act of transferring a cloned embryo into a woman’s womb becomes definitive proof of the attempt and triggers criminal penalties for those doctors or scientists who make the attempt. Critics of this approach express concern that such legislation would be difficult to enforce, and urge Congress to ban basic research lest it lead to the prohibited act of transferring a cloned embryo into a womb for development. But criminal law is almost always grounded in a theory of deterrence. We do not prohibit the manufacture of guns in order to guard against the possibility of their future misuse in homicide. Rather, we criminalize misuse of guns and prosecute the offenders accordingly. Critics of this approach also worry that this it leaves other, non-reproductive forms of research unregulated, and fear it may lead to exploitation of egg donors or the diversion of this research toward eugenic ends. But these critics overlook both the extensive existing regulation of cloning research and the additional regulatory safeguards that have been proposed in new legislation before the Senate. If and when cloning research is done for therapeutic ends, that is, when it is done to produce embryos whose stem cells will be transplanted back into the donor in an effort to repair or regrow damaged tissues of the brain, the heart and other organs, it is clearly and indisputably covered by the FDA regulations on cell-based therapy and transplantation. These regulations cover all such research, even when it is done with private funding. FDA’s regulations cover myriad aspects of the research, from the laboratories where it may be done, to the collection of eggs, to the nuclear transfer procedure, to the derivation of stem cells, to the final transplant back to the donor. And FDA regulation also requires that every aspect of the work be carried out under the strict oversight of an Institutional Review Board (IRB), whose job is to guarantee that eggs are donated only after voluntary and fully informed consent. IRBs ensure that reimbursement to egg donors for their time and inconvenience is reasonable and poses no risk of donors being tempted to abandon their own good judgement. And IRBs review the scientific basis for the information given to egg donors about the risks associated with egg donation, as well as the actual documents they will be given to ensure that their consent is genuinely informed. IRBs also monitor research, with periodic updates to guard against unexpected side-effects in donors or unexpected problems in the laboratory management of the cloned materials and stem cells. This is the same, comprehensive scheme of protections used generally for human subjects research, and our experience in the United States demonstrates that research with human subjects, is not only extremely safe, it is far safer than the ordinary practice of medicine. This system of protections is supplemented with an extra layer of safeguards whenever genetic engineering is introduced into research. If and when cloning research comes to involve genetic manipulation of any sort involving the embryo or its stem cells, it will also be screened by the federal Recombinant DNA Advisory Committee, which has long functioned as the gatekeeper to gene therapy. This committee’s charge is broad, and it is empowered to examine every aspect of research to ensure its safety for all participants. S. 303 would extend this comprehensive system of protections to all cloning research, by extending the Common Rule for human research protections even to privately funded research that does not involve transplanting the resulting stem cells back into the donor. Unique to cloning research is the possibility of cloning tissue from women who suffer from breast cancer or autoimmune diseases, so that specialized stem cell lines that exhibit these diseases can be grown in the laboratory for further research and testing. No other source of stem cells, neither those from surplus IVF embryos at infertility clinics nor those from bone marrow or other sources of adult stem cells can be used for this crucial research. Here, S. 303 would require informed consent from egg donors and oversight by IRBs, so that no aspect of cloning work, whether for therapeutic or purely research purposes, would proceed unmonitored. Given the extensive regulation that already exists, and the proposals for extending that regulation even further, outright prohibitions or moratoria on cloning research are unduly burdensome and subject to constitutional challenge. For thirty years, federal courts and nationally recognized scholars have discussed the scope of the First Amendment and its protection of scientific research as part of the freedom of thought, inquiry, and dissemination of knowledge that is at the core of that aspect of the Bill of Rights. Research is an integral part of the scientific method, a form of inquiry that fits uniquely within the purposes, histories, and structures of the First Amendment. Thought and the testing of thoughts through science facilitates the dissemination of ideas just as much as monetary contributions to political candidates facilitates the expression of political ideas. Indeed, in many cases, research is in and of itself a form of challenging political ideas. In other places and other times, governments have sought to ban the dissection of human bodies, because it would interfere with deeply felt notions of the body as a reflection of the divine order, or have sought to ban investigation of the orbits of the planets, as it would interfere with essential views about the place of humankind in the universe. So, too, does investigation of the origins of life, of the secrets of conception and development, threaten our deepest views concerning the sources of life. But the First Amendment exists precisely to protect the development and dissemination of knowledge and truth and opinion, so that they may be tested and re-tested over time in the marketplace of ideas. Certainly, even protected activities are subject to reasonable regulation to avoid interfering with the rights of others. But where prohibitions are designed merely to guard against the development of knowledge, for fear it might someday lead to new and controversial ways to manipulate cells and genes, they run afoul of the very basis of the First Amendment protection of inquiry, association, and dissemination. And where prohibitions are designed to guard against violating the rights of embryos, they run athwart of the legal reality that federal law does not grant embryos the same rights as live-born children. Indeed, the Supreme Court has repeatedly reiterated its view that even while science, theology and philosophy continue to debate the biological and moral status of the embryo, the Constitution does not grant them the rights of other persons under the law. Any federal law that goes beyond reasonable regulation of cloning research and enacts a temporary or permanent ban on this form of scientific inquiry is thus vulnerable to challenge in court as an interference with the First Amendment rights of patients and researchers. Such challenges might well result in an injunction to forbid enforcement of the federal law until judicial review has been completed, a process that can take years. During such a hiatus, the federal law is inoperative, thus thwarting Congressional efforts to use legislation to prevent reproductive uses of cloning. If the Congress wishes to take action with regard to reproductive cloning, I urge it to focus on legislation that prevents that unsafe practice. I also urge it to adopt the additional regulatory protections proposed in S. 303 for research and therapeutic applications of cloning, so that the public can be reassured that every measure has been taken to guide this research along a responsible path. A separate debate, on embryo research generally or non-reproductive cloning research in particular, can always proceed separately, to be debated on its own merits, and ultimately to be tested on its own terms before the constitutional authorities of the nation.

• Mr. Andrew Kimbrell
  Read statement

  Witness Panel 2

  Mr. Andrew Kimbrell

  International Center for Technology Assessment 660 Pennsylvania Ave., SE., Suite 302, Washington, DC 20003, (202) 547-9359 fax (202) 547-9429 Testimony before the Subcommittee on Science, Technology and Space, U.S. Senate Committee on Commerce, Science and Transportation SR-253 9:30 a.m. 27 March 2003 Statement of Andrew Kimbrell Executive Director International Center for Technology Assessment Mr. Chairman and Members of the Committee: My name is Andrew Kimbrell. I am the Executive Director of the international Center for Technology Assessment, an attorney and author of The Human Body Shop: the engineering and marketing of life (Harper Collins 1991, 3rd Edition 1998). I am here today as part of a broad coalition of progressive environmental, consumer and women̓s health groups who agree that responsible policy on the matter of human cloning requires a ban on reproductive cloning and a moratorium on human cloning for research. The potential impacts to women of human reproductive cloning, but especially, human research cloning have received insufficient attention in the cloning debate, and I̓m grateful to the committee both for recognizing the importance of this issue and providing me the opportunity to testify today. I̓d like to begin by summarizing the physical and psychological risks to women posed by human reproductive and research cloning. I will then provide a brief analysis of S. 303, introduced by Senators Hatch and Feinstein and explain why, as currently written, this bill would neither effectively ban human reproductive cloning nor provide adequate protection to women. Tire Impacts of Human Cloning to Women Human cloning is a process in which a nucleus from a human somatic cell is fused with an enucleated human egg cell to produce a cloned embryo. The technical term for this process is “somatic cell nuclear transfer.” There are two potential uses of cloned embryos produced by nuclear transfer, each of which pose significant risks to women. In the case of human reproductive cloning, cloned embryos would be transferred into a woman̓s uterus, and, if brought to term, would result in a child that would be a genetic duplicate of the nuclear donor. in the case of human cloning for research purposes, these cloned embryos would be used to develop stein cell lines for regenerative tissue research. The following describes the risks to women posed by each of these two types of human cloning. Human Reproductive Cloning Human reproductive cloning is widely condemned and has been outlawed by more than 30 countries. Many scientists agree that reproductive cloning is an inherently unsafe procedure that could only he made “safe” by carrying out extensive, unethical experimentation on women. The physical risks associated with this procedure cannot be overstated. Almost all cloning experiments in mammals have resulted in miscarriages, stillbirths, and deformities. Many efforts to clone mammals have resulted in abnormally large fetuses, often up to twice the average size. In humans, “large offspring syndrome” of this magnitude could be fatal to a surrogate mother as well as to the fetus. Finally, experiments in mammals have been highly inconsistent and unpredictable. As such, endless experimentation with mice, sheep, cats, even monkeys may never provide us the level of confidence required to attempt this procedure in humans. As many scientists, health professionals, ethicists and others have noted, these insurmountable risks, alone, warrant a permanent ban on human reproductive cloning. In addition, reproductive cloning poses significant psychological and social risks to women. Surrogate mothers who would have to undergo the stillbirths and miscarriages and witness the deformities involved in attempting to create a successful clone would suffer an enormous emotional and psychological toll. In addition, if reproductive cloning were allowed, an increase in demand for surrogate mothers would exacerbate an already coercive market in the buying and selling of women̓s wombs. That demand would likely be met by low-income women, pressured into selling their bodies as “mother machines” to those who can afford the price. Human Embryo Cloning for Research The impacts to women (and social consequences, generally) posed by human research cloning have been less widely discussed, but are nonetheless compelling. They include the following: • Research cloning is a highly inefficient process, which would require an unlimited supply of human eggs. It has been estimated that research cloning might be able to provide up to 1.7 million therapies per year. Assuming a highly optimistic success rate of I stem cell culture per 5 cloned embryos, and one cloned embryo per 10 eggs, these therapies would require 85 million eggs, or 8.5 million egg donors. • Egg donation is a burdensome, risky, and painful procedure. Egg donation is not a simple process; it lasts several weeks, and includes repeated injections of fertility hormones and super-ovulatory drugs and finally, surgery. Risks associated with egg extraction include a potential link to ovarian cysts and cancers, severe pelvic pain, abdominal bleeding, and ovarian hyperstimulation syndrome, a potentially life-threatening condition. • An explosion in demand for human eggs would exacerbate the coercive nature of the lucrative egg donation industry. Currently, compensation to women for egg “donation” is uncapped, and ranges from an average payment of S5,000-$6,000 to as high as $80,000. The increase in egg demand created by research cloning is likely to increase the price of eggs and coercive potential of the egg market • The burden of egg supply will likely fall on underprivileged women. There are no federal standards concerning limitations on the number of times a woman can donate eggs. Low-income women may feel obliged to choose repeated egg donation as a source of income. • Research cloning will result in a loss of choice for women. Researchers can clone embryos from any number of body cells. A woman̓s cells could be removed for the creation of any number of cloned embryos without her knowledge or choice. • The perfection of techniques to create cloned human embryos through research cloning would make it far more likely that reproductive cloning will occur. The major barrier to successful reproductive cloning lies not in implantation, but in the development of the ability to clone embryos free of reprogramming errors. Allowing the creation of cloned embryos would encourage the perfection of this technical barrier, after which uterine implantation would be a trivial step. As such, research cloning is the gateway for eventual reproductive cloning and its profound impacts on women̓s health described above. • Perfection of research cloning techniques will also open the door to creating “designer babies.” Inheritable genetic modification, or germline engineering, is a process that involves changing genes that are passed on to future children. This technique has been used to create “transgenic” animals for commercial and research purposes, and some scientists and others are advocating its acceptance and use in humans. Perfection of research cloning techniques is necessary for “designer babies” to become commercially practicable. Allowing genetic “enhancements” in humans would unleash a powerful new eugenics, and could lead to unacceptable forms of genetic discrimination and inequality, not unlike those that many advocates for women̓s health and rights have worked so hard to overcome. A Misguided Legislative Approach: S. 303 On February 5, 2003, Senators Hatch (R-UT), Feinstein (D-CA), Specter (R-PA), Kennedy (D-MA), Harkin (D-IA), and Miller (D-GA) announced the introduction of S. 303, a new bill to address the issue of human cloning. At a hearing held by the Senate Committee on the Judiciary on March 19, Senator Hatch stated that the purpose of the bill is twofold: 1) to stop any attempts to facilitate the birth of a cloned baby; and 2) to allow a promising form of stem cell research to go forward under “strict ethical guidelines.” A closer examination of S. 303 reveals that neither of these goals will be accomplished by this bill. In particular, the bill, as currently written, will not effectively prevent human reproductive cloning, nor will it adequately protect women. CTA is preparing a thorough, in-depth analysis of this deeply flawed and misguided legislation, which it will provide the committee in the near future. However, today I would like to focus on just a few of the more egregious failings of 5.303 S.303 Fails To Effectively Prevent Human Reproductive Cloning: Among the changes from last year̓s incarnation of this bill is its use of the term “unfertilized blastocyst” to describe a cloned human embryo. The use of this term appears to beintentionally misleading. It suggests that, once created, clonal embryos (i.e. “unfertilized blastocysts”) could he distinguished from “fertilized” embryos, namely those created from the union of an egg and a sperm. Additionally it seems to suggest that the “unfertilized blastocyst is in some way not viable, that if it were transferred to a woman̓s womb it would not result in a child. It is true that a cloned embryo is not fertilized in the traditional sense, by way of the union of an egg and sperm. However a cloned embryo is potentially as viable as a conventional embryo and if implanted in a womb could result in a cloned child. Moreover, and very importantly, once created a cloned embryo (“unfertilized blastocyst”) cannot be distinguished from a “fertilized” embryo. To repeat once an embryo is cloned it is biologically identical to a fertilized embryo and cannot be distinguished from a fertilized embryo nor identified as a cloned embryo. This important fact, purposely obscured by S.303, underscores the enormous challenge in enforcing any restriction on the sale or use of cloned embryos after they have been created. The bill̓s allows for the production of an endless supply of cloned human embryos without acknowledging that once they are produced they are biologically identical to conventional embryos and will be virtually impossible to find. This simple fact demonstrates that any attempt to regulate the use of cloned embryos after they have been created is legislating the impossible. imagine trying to regulate the use of drugs or firearms if they became invisible once they were created and you get the scope of the difficulty in enforcing the ban on reproductive cloning attempted by S. 303. Clearly the only coherent approach to halting reproductive cloning is at the supply level, that is to either ban or significantly restrict the creation of cloned embryos. S.303 does the reverse. it encourages the creation of cloned embryos but does not in any way provide direct oversight of the number of facilities creating human cloned embryos, limit the number of clonal embryos created, or create a strict chain of custody requirement for each individual cloned human embryo produced for research purposes. As such, there is no way to ensure that cloned embryos purportedly produced for research purposes are not subsequently transferred to a woman̓s uterus. This potential that these embryos will be used for reproductive cloning is exponentially increased because the bill explicitly allows for: 1) freezing; 2) transport; and 3) export of cloned human embryos. Without either a ban on the production of cloned embryos or a highly restricted production of cloned embryos that is subject to a rigorously enforced system of monitoring that tracks the chain of custody of each and every cloned human embryo produced, there can be no way to ensure that attempts to clone human beings are not being undertaken. S.303 provides for neither of these alternatives and therefore will completely fail in its stated purpose of halting human reproductive cloning and will also fail in preventing the serious impacts on women̓s health which reproductive cloning will bring. Rather than addressing this enforcement issue directly, S. 303 calls for a series of reports on enforcement mechanisms found in state or international laws to be completed one year after the bill has been passed. This is incomprehensible. Allowing human cloning to proceed for a year, or potentially several years, while various enforcement schemes are reviewed and studied in order to arrive at adequate enforcement is legally incoherent. The whole point of regulatory legislation is to develop an effective enforcement regime before allowing a certain potentially harmful activity to proceed, riot after it has been disseminated and creates the harm the legislation was intended to avoid. S.303 Fails to Provide Adequate Protection to Women Egg Donors: The bill assigns the primary load of protecting women in research cloning to existing human subject protection regulations. Yet it is probable that these regulations would not even apply to egg donors or somatic cell donors. This is because these donors would not be “research subjects̓ as contemplated under the regulations; instead, they are “donors” of biological material, not a class currently covered under the regulations. Even if these regulations did apply, companies involved in cloning embryos could avoid these requirements by obtaining human eggs and cells from outside sources and not directly from the donors. In addition, standards of Investigational Review Board (IRB) review are not the most efficient or practical way to provide consistent protection to these participants. Decisions about the appropriate process for extracting and using human eggs and somatic cells in research should not be made on an individual, case-by-case basis, or left to the whim of a given IRB. Instead, federal standards should be developed that are specific to women̓s health concerns. I would add that the bill̓s reliance on IRBs as the primary means to monitor and control human cloning activity also ignores serious issues that have been raised about these Boards. A number of recent major failures in human research protection have lead me, and many in the scientific community, to believe that most of the important issues raised in the 1998 HHS Office of Inspector General Report “Institutional Review Boards: A Time for Reform” have yet to be effectively addressed. In this 1998 report the Inspector General found that 1RBs: - reviewed too much, too quickly, with too little expertise; - conducted minimal continuing review of approved research; - faced conflicts that threatened their independence; and - provided too little training for investigators and board members. They also found that neither IRBs nor HHS devoted much attention to evaluating IRB effectiveness. In a follow up investigation in 2000, the OIG found that while several promising steps had been taken by NIH and FDA, few of the recommended reforms had been enacted. Of particular continuing concern to the IG were the areas of: ▸ flexibility and accountability; ▸ oversight and human protections; ▸ board and investigator education; ▸ conflicts of interest; ▸ workload; and ▸ federal oversight. Virtually the same list as in 1998. Given these findings, if we are serious about ensuring that reproductive cloning cannot occur, and that women̓s health be protected IRBs are not any kind of answer for at least the foreseeable future. Let me conclude with S. 303̓s handling of the exploitation of women in the egg donation process. There can be no doubt that the endorsement of research cloning in 8.303 would stimulate a major expansion in the market for women̓s eggs. At the same time, the bill does not adequately address the coercive aspects of the egg donation industry, which would be exacerbated by a massive increase in the demand for women̓s eggs. While the bill prohibits the purchase or sale of human eggs for use in embryo cloning research “for valuable consideration”, it does so with a large loophole. While “valuable consideration” is prohibited the bill does allow for payment to egg donors for the “time or inconvenience” associated with the donation. This vague provision has been used for years by institutions around the country to allow them to pay tens of thousands of dollars to egg donors. Ultimately, there is little real difference between paying for eggs or for the “time and inconvenience” of their removal. “It̓s almost a matter of semantics,” admits Joyce Zeitz, former public relations coordinator for the American Fertility Society. Legal scholar George Annas sees the term “inconvenience” as nothing more than a ruse: “Of course, you̓re not really buying a woman s inconvenience. It̓s a bogus argument that your not actually selling these eggs. Clearly, donors are selling their reproductive capacity. And if you can sell your egg, then why shouldn̓t you sell your child too?” In contrast to S.303 language, I would point out that the U.S. Organ Transplant Act prohibiting sale of organs does not have the “time and inconvenience” loophole. I would further note that S.303 contains no caps on the number of times a woman can donate/sell eggs. As such, economically disenfranchised women are likely to become repeat donors In sum, if passed S.303, will encourage unlimited production of unidentifiable cloned embryos. This will not halt but rather facilitate human reproductive cloning and thus will completely fail to adequately protect women health from the dangers of all forms of human cloning. The bill is deeply flawed both in concept and in its specifics. It is simply irresponsible legislation. Thank you.