Americans to Ban Cloning

Testimony of Richard Doerflinger before the Deleware House of Representatives, Health and Human Development Committee

Date: 01/14/2004

before the
Health and Human Development Committee of the Delaware House of Representatives

concerning
Senate Bill No. 55, “Cloning Prohibition and Research Protection Act”

 

My name is Richard Doerflinger. I am Deputy Director of the Secretariat for Pro-Life Activities, U.S. Conference of Catholic Bishops, and Adjunct Fellow in Bioethics and Public Policy at the National Catholic Bioethics Center. I have been invited by the Catholic Diocese of Wilmington to offer comments on the proposed bill on human cloning, Senate Bill No. 55.

Prohibiting human cloning is a worthwhile legislative goal. Human cloning is the ultimate step toward depersonalized procreation, in which fellow human beings are “manufactured” in a laboratory according to preset specifications. It inevitably treats human beings as objects of research and even as commodities, instead of as members of the human family with inherent human dignity. As Dr. Leon Kass, chairman of the President’s Council on Bioethics, has written, through human cloning “we…would be taking a major step into making man himself simply another one of the man-made things.”1 Not only all Christians, but all who support the very idea of human dignity, should work to prevent anyone from taking that step.

However, SB 55 as written is not a morally acceptable or legally workable response to this problem. In fact, it would encourage human cloning under the guise of attempting to ban it — which is why it is supported by biotechnology companies that favor human cloning for research purposes.

At first it can be difficult to assess this bill because its terms are inconsistent and ill-defined. Its operative provision is deceptively simple: “No person shall create or attempt to create a human being using somatic cell nuclear transfer or other cloning technologies.” Yet the bill does not define key terms such as “human being,” “create a human being,” “cloning technologies,” or even “cloning” itself. Instead the definitions section defines various terms that do not appear in the operative part of the bill: “embryo,” “fetus, ” “the creation of a human child,” etc. This alone may render the bill unconstitutional due to vagueness. Moreover, some of the definitions are clearly misguided. For example, “the creation of a human child” is defined as the implanting in a womb of an embryo created by the cloning procedure known as somatic cell nuclear transfer – yet transfer to a womb does not “create” anything , but only changes the location of a being already in existence; and while there have been several ways throughout human history to create a human child, none of them (as far as we know) has involved implanting a cloned embryo in a woman’s womb. To equate “the creation of a human child” with implanting a cloned embryo in a womb also seems to imply (among other things) that only cloned children are human children, which cannot have been intended. Even if this and other drafting errors could be resolved, however, the bill would still be unacceptable.

Grave defects in SB 55

As best one can tell, it seems that what the bill seeks to prohibit is the activity described in its definition of “the creation of a human child” :

implanting into the uterus of a human female, for gestation and

subsequent birth, the product of a nuclear transfer of a human somatic

cell into a enucleated human oocyte.

Apparently the intent here is to prevent cloning researchers from producing live-born cloned children in the state of Delaware.2 But amazingly, instead of banning the use of the cloning procedure to create humans in the first place, SB 55 instead seeks to ban live birth. This bill as written should therefore be rejected, and replaced with a genuine ban on human cloning. SB 55’s chief defects are as follows:

1. Conceptually, this is not a ban on cloning at all. A cloning procedure such as somatic cell nuclear transfer is conducted at the one-celled stage, and produces a new embryo that is genetically identical (or almost identical) to another human. Once that occurs, “cloning” is finished, and all that remains is the natural developmental process that every human goes through.3 SB 55 bans, not a cloning procedure, but an entirely distinct procedure that has been performed for many years in Delaware and around the country: the procedure known as embryo transfer. In effect, SB 55 will make it illegal to initiate a pregnancy if the embryo involved was originally created by cloning.

2. Practically, such a ban will be ineffectual even in slowing progress toward so-called “reproductive cloning.” It will still allow all the research in use of cloning to produce human embryos that researchers need in order to develop and “perfect” the process. And once that technical progress is achieved and clonal “embryo farms” exist in laboratories throughout the state, how will anyone effectively stop a researcher from placing one of these embryos in a womb? Embryo transfer, the procedure SB 55 tries to prohibit, takes place every day using embryos fertilized in the laboratory.4 Indeed, once the embryos are created there is no reliable way to determine which were created by fertilization and which by cloning.5 Even if such a test were available, will the state of Delaware really demand that every embryo ready for implantation in a fertility clinic be screened to exclude those created by cloning? The prospect seems absurd.

3. Legally, such a law cannot be enforced without raising serious issues, including constitutional issues. Instead of banning a laboratory procedure done outside women’s bodies, SB 55 tries to regulate what kinds of embryos women are allowed to become pregnant with. Yet current constitutional jurisprudence recognizes women as having the freedom to make their own decisions about whether to conceive or bear a child (and sees physicians as having a corollary freedom to assist them in acting on these decisions). The problem is especially acute if a cloned embryo has already been placed in a woman’s womb: It seems that this law would place constitutionally suspect governmental pressures on the woman to have an abortion.6

4. Morally, this law shows a contempt for human life in its early stages that is unprecedented even in the abortion debate. By allowing the use of cloning to create human embryos, but then prohibiting the only activity (transfer to the nurturing environment of a womb) that could allow these embryos to survive, the law would define a set of developing members of the human species that it is a crime not to discard or destroy – a class of human life whose only legally accepted use is as fodder for a research enterprise. The responsibility of the state of Delaware, under this bill, would be to locate any cloned embryos in the state and monitor their exploitation by biotechnology companies, to make sure that none of the victims escapes alive. The state’s traditional responsibility to protect the weak and vulnerable from those who would exploit them for profit would be turned on its head.

5. Further, the bill specifies that implanting a cloned embryo in a womb is illegal only if it is done “for gestation and subsequent birth.” Mass-producing cloned embryos, then implanting them in wombs to abort them for their cells and tissues at any point before the moment of birth, would be permitted. This may not have been the intent of Delaware legislators, but it is entirely deliberate on the part of the for-profit biotechnology companies who have promoted such legislative language in Delaware and at least eight other states in the past year.7 Such a “fetus farming” bill has already been enacted into law in New Jersey this month, with the endorsement of the national Biotechnology Industry Organization (BIO). Cloning researchers are promoting this grotesque agenda because their own studies in animals suggest that it may be necessary to gestate cloned embryos well into the fetal stage to obtain usable cells and tissues for transplantation.8

6. This aspect of the bill further aggravates the problem of enforcement. Since the bill allows gestation of cloned embryos in women’s wombs only so long as this is not done in order to produce a live birth, the task of law enforcement officials in Delaware would essentially be to monitor the pregnant women involved and ensure that they have abortions. Does anyone seriously believe that under our federal Constitution, courts will uphold a government mandate for abortion whenever a woman changes her mind and decides to allow the cloned child in her womb a chance to live? If not – if, once begun, such a pregnancy would have to be allowed to proceed — then Delaware will have effectively permitted every aspect of “reproductive cloning,” the very activity this bill is ostensibly designed to prevent.

7. Inevitably this bill’s effects would be as much anti-woman as anti-life. To conduct cloning for research purposes, researchers must hire women to supply a huge number of human eggs – presumably using fertility drugs to stimulate hyperovulation, a process that can increase women’s risk of ovarian cancer and other health problems.9 Then women will have to be exploited as “surrogate” wombs to gestate the resulting embryos to the desired fetal stage. Finally, the state will have to impose legal scrutiny on these women to ensure that they do not break the law by seeking a live birth, and place pressure on them to have abortions in order to prevent “reproductive cloning.” Not only cloned embryos, but women themselves would effectively be reduced to instruments of the research enterprise under such a policy.

The myth of “therapeutic cloning”

Why would the state of Delaware create these moral, legal, medical and even constitutional problems? Presumably legislators believe they must engage in these convolutions to protect so-called “therapeutic cloning,” more accurately called “research cloning” or “human cloning for biomedical research purposes.” They have been told that if they allow biotech companies to mass-produce cloned embryos and destroy them for their stem cells, this will provide genetically matched tissues for patients with various debilitating conditions and usher in a new era of progress in regenerative medicine.

However, the claim that progress in regenerative medicine relies on research cloning is, to put it mildly, “more dream than reality” (to use the words of the New York Times ).10 This is true for several reasons:

1. Despite many years of attempts around the world, there is still no documented success in even creating a cloned human embryo. Some initial reports of success were later called into question, for they produced no being that survived long enough to assess (let alone long enough to produce embryonic stem cells).11

2. Again, despite many years of effort, even animal studies have produced no breakthroughs in therapies using stem cell s from cloned animal embryos. It turns out that cloned embryos often fail to activate key genes that are essential for the formation of “pluripotent” stem cells.12 The rare alleged successes have actually required gestating the cloned animal embryo to the fetal or even newborn stage to obtain usable cells for transplant. The latest studies indicate that cloned embryos suffer from enormous problems in chaotic gene expression – problems which the developing embryo cannot fully correct until a later stage of fetal development.13 This helps explain why biotech companies now want bills like SB 55, to allow gestating cloned embryos in wombs (as long as there is no live birth).

3. The claim that cloning is necessary for successful stem cell therapies rests on the claim that it can produce genetically matched cells that will not be rejected by the immune system of the patient needing new cells. Yet animal studies show that cells taken from cloned embryos can still be rejected by the animal that was replicated. Apparently there is more to a successful tissue match than simply genetic similarity.14-derived hematopoietic cells are distinct from the normal adult HSC [hematopoietic or blood-producing stem cells] and may represent the future challenge in using ES-derived cells for therapeutic purposes.” R. Tsai et al., “Plasticity, Niches, and the Use of Stem Cells,” in 2 Developmental Cell 707-12 (June 2002) at 710. In plain English, even when they seem to be a genetic match, embryo-derived cells may be inherently different from adult cells in ways that make them poor candidates for therapies.] At the same time, new and promising ways to solve the problem of immune rejection have come forward, and the latest findings suggest that this may not even be a problem in treating conditions of the nervous system such as Parkinson’s, spinal cord injury, Alzheimer’s, etc. – because adult neural stem cells are “invisible” to the immune system, provoking no immune response when placed in unrelated hosts.15 If this finding is confirmed, “therapeutic cloning” will (at the very least) be irrelevant to all therapies for brain and nerve conditions.

4. These problems with cloning are in addition to problems with embryonic stem cells generally, which have proved enormously difficult to harness and direct for any clinical goal. Among other things, these cells have a disturbing tendency to proliferate in all directions uncontrollably and form cancerous tumors in host animals.16 A very recent study has confirmed that human embryonic stem cells tend to accumulate certain additional chromosomes when they develop in culture – the very chromosomes most closely associated with testicular cancer cells.17 To claim that any embryonic stem cell therapy will be ready for human use without (at least!) years of work in assessing the tumor formation problem in animals would be dangerous and medically irresponsible.

5. A growing number of researchers who favor embryonic stem cell research now admit that even if it can be made to work at all, “therapeutic cloning” would be enormously expensive, time-consuming, and virtually unworkable as an approach to providing clinical benefits. The sheer cost (in money, and in the risk of harm to women) involved in any effort to harvest enough eggs and treat the patients suffering from even one major disease would be astronomical.18 Smart researchers (and smart investors) are turning elsewhere.

6. Finally, it is increasingly obvious that allowing cloning for biomedical research is not necessary (or even helpful) in making states or countries into centers of growth and progress in biotechnology. On the contrary, some states (and countries) that have banned human cloning for research purposes are the fastest-growing centers for biotechnology progress in the world.19

Conclusion

In short, there is one legally and morally responsible way to ban human cloning, and that is to ban the use of the cloning procedure to create humans in the first place. Iowa, Arkansas, North Dakota and Michigan have already enacted genuine laws against human cloning, and I urge Delaware to follow their lead.20

I want to end with a message of hope, for all patients and families who have been misled by exaggeration and hype to believe that they must support human cloning if they want cures for devastating diseases:

Medical science is indeed making rapid progress toward successful treatments for Parkinson’s disease, diabetes, cardiac damage, spinal cord injury, sickle-cell anemia and other debilitating conditions – without raising the legal and moral problems of human cloning. In fact, all the conditions I have just named are being treated in human patients now in very promising clinical trials, using adult cell therapies or other non-controversial sources of stem cells such as umbilical cord blood.21 Patients are being treated, and lives are being saved – without treating any other human lives as mere disposable property. It is in this direction that our collective resources should be focused. A complete ban on the moral, legal and medical “dead end” that is human cloning will advance this worthy goal, and direct our considerable scientific resources to producing cures that all Americans can live with.

  1. L. Kass, “The Wisdom of Repugnance,” in The New Republic, June 2, 1997, p. 23.
  2. Note that this ban applies only if a human egg and a human womb are used.  Cloning efforts that involve inserting the genetic material of a human cell nucleus into a non-human egg (already being attempted by some researchers), that seek to produce a human-animal hybrid, or that use an animal or “artificial” womb would be completely exempted from the ban even if done to attempt a live birth.
  3. For example, the National Academy of Sciences defines “cloning” as the production of “an organism that has the same nuclear genome as another organism,” and recognizes that the one-celled embryo or zygote of the human species is “developing human,” an organism of the human species.  This scientific reality is independent of any differing views about the moral or legal status of human embryos.  See: National Academy of Sciences, Scientific and Medical Aspects of Human Reproductive Cloning (National Academy Press 2002), pp. E-4 and E-5; USCCB Secretariat for Pro-Life Activities, Fact sheet, “What is Human Cloning?”, June 3, 2003.
  4. Commenting on a similar federal bill, the U.S. Department of Justice notes that “the prohibited activity ‘transfer of an embryo to a uterus’ is an activity that is otherwise permitted now in all states and is performed thousands of times a year in fertility clinics. This legislation obviously is not intended to establish a broad prohibition on such lawful activity. However, the transfer of an embryo to initiate a clinical pregnancy is presumably the same regardless of whether the embryo involved was originally produced by cloning or fertilization. Hence, there is no visible difference between the prohibited activity and the permitted activity, both of which would presumably be conducted within the privacy of a hospital or medical office. Entrusted with enforcing such a limited ban, law enforcement would be in the unenviable position of having to impose new and unprecedented scrutiny over doctors in fertility clinics and/or research facilities to ensure that only fertilized embryos were being transferred to would-be mothers.”  Statement of  U.S. assistant attorney general Daniel J. Bryant before the House Government Reform Committee, May 15, 2002, at www.cloninginformation.org/congressional_testimony/bryant_02-05-15.htm.
  5. As the Department of Justice notes, “at the point when embryo transfer occurs, which is at the blastocyst stage (about 5-6 days after the embryo is produced), there does not seem to be any reliable means for determining the difference between a fertilized embryo and a cloned embryo… Moreover, if a researcher mixed cloned and fertilized embryos in culture and then implanted only some of these embryos, there would simply be no way for a prosecutor to prove that the implanted embryos were the ones which arose from cloning. Even after the fact, it is not clear how one could determine that the fetus in utero was originally produced by cloning, unless one could demand a prenatal genetic profile and show that this profile is genetically virtually identical to a particular pre-existing individual.”
  6. In the Justice Department’s words, “except in those exceedingly rare instances when the parties involved announced their intention to engage in unlawful activity in advance, it is difficult to envision how law enforcement officials could effectuate the stated goals …of preventing the birth of cloned infants. For example, once a pregnancy were established, any government-directed attempt to terminate a cloned embryo in utero would create problems enormous and complex.”
  7. See Americans to Ban Cloning, “Recent state cloning bills: taking cloned embryos into the fetal or newborn stage,” March 26, 2003.
  8. In one study, efforts to correct an immune deficiency in mice were not clinically successful until a cloned and genetically modified mouse was gestated to the newborn stage to obtain its adult stem cells. W. Rideout et al., “Correction of a Genetic Defect by Nuclear Transplantation and Combined Cell and Gene Therapy,” 109 Cell 17-27 (April 5, 2002). For a critique see Americans to Ban Cloning, “Why the ‘Successful’ Mouse ‘Therapeutic’ Cloning Really Didn’t Work,”. Another study found it necessary to gestate cloned cow embryos into the fetal stage and then abort them to provide usable kidney tissue for the original cow. R. Lanza et al., “Generation of histocompatible tissues using nuclear transplantation,” 20 Nature Biotechnology 689-96 (July 2002). 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. at 689. Now, however, supporters of human cloning for research purposes claim that this study is a model for “therapeutic cloning.” They have done this by simply redefining the phrase “therapeutic cloning” to encompass human fetus farming. See Do No Harm press release, “Reality Check: Proof of ‘Therapeutic’ Cloning?”, March 10, 2003.
  9. See W. Saunders, Esq., “The Impact of Human Cloning on Women,” Family Research Council fact sheet, at www.frc.org/?i=LH03C2
  10. G. Kolata, “The Promise of Therapeutic Cloning,” The New York Times, January 5, 2003, sect. 4, p. 7.
  11. See G. Stix, “What Clones?: Were claims of the first human embryo premature?”, Scientific American Online, December 24, 2001.
  12. See A. Bortvin et al., “Incomplete reactivation of Oct4-related genes in mouse embryos cloned from somatic nuclei,” in 130 Development 1673-80 (2003) (showing that “cloned embryos derived from differentiated cell nuclei fail to establish a population of truly pluripotent embryonic cells because of faulty reactivation of key embryonic genes such as Oct4”). Providing genetically compatible “pluripotent” stem cells for possible therapies has been touted as the central justification for research cloning.
  13. See J. Fulka et al., “Do cloned mammals skip a reprogramming step?”, in 22 Nature Biotechnology 25-26 (January 2004) (concluding that this finding poses serious problems for both “reproductive” and “therapeutic” cloning).
  14. NIH stem cell expert Ronald McKay and his colleagues observe that in the “therapeutic cloning” study by Rideout et al. (see note 8 supra), “the donor cells, although derived from the animals with the same genetic background, are rejected by the hosts… These unexpected findings suggest that the ES [embryonic stem cell
  15. See: J. Hori et al., “Neural Progenitor Cells Lack Immunogenicity and Resist Destruction as Allografts,” in 21 Stem Cells 405-16 (2003); S. Bhattacharya, “Immune ‘invisibility’ of brain stem cells proven,” in New Scientist, 18 July 2003. For another recent advance in solving the immune rejection problem using adult stem cells, see J. Down and M. White-Scharf, “Reprogramming Immune Responses: Enabling Cellular Therapies and Regenerative Medicine,” in 21 Stem Cells 21-32 (2003).
  16. Says an ethicist who supports embryonic stem cell research: “The emerging truth in the lab is that pluripotent stem cells are hard to rein in. The potential that they would explode into a cancerous mass after a stem cell transplant might turn out to be the Pandora’s box of stem cell research.” Dr. Glenn McGee of the University of Pennsylvania, quoted in E. Jonietz, “Innovation: Sourcing Stem Cells,” Technology Review, January/February 2001. For a recent vivid example of this problem, see S. Wakitani et al., “Embryonic stem cells injected into the mouse knee joint form teratomas and subsequently destroy the joint,” in 42 Rheumatology (2003), 162-5.
  17. J. Draper et al., “Recurrent gain of chromosomes 17q and 12 in cultured human embryonic stem cells,” in Nature Biotechnology, advance online publication 7 December 2003, doi: 10.1038/nbt922.
  18. See USCCB Secretariat for Pro-Life Activities, Fact sheet, “Practical Obstacles to ‘Therapeutic’ Cloning,” January 14, 2004 (attached).
  19. See USCCB Secretariat for Pro-Life Activities, Fact sheet, “Human Cloning and Embryo Research: No Road to Biotechnology Growth,” January 14, 2004 (attached).
  20. The new law enacted by North Dakota in 2003 is especially concise and well-drafted, and is attached to this testimony for the legislature’s consideration. That law, and similar laws in Iowa and Arkansas, are modeled on the federal “Human Cloning Prohibition Act” (S. 245) now pending in the U.S. Senate, which has been approved twice by the U.S. House of Representatives and endorsed by President Bush.
  21. See the brief overview in A. Fagan, “Adult stem cells produce treatment breakthroughs,” in The Washington Times, December 29, 2003, p. A3, and numerous news reports and scientific journal articles posted on the web site of Do No Harm: The Coalition of Americans for Research Ethics. One recent in-depth survey of recent advances in adult stem cell research, including 192 citations to the professional literature, is Dr. David Prentice’s July 2003 testimony to the President’s Council on Bioethics.