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What justifies the United States ban on federal funding for nonreproductive cloning?

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Abstract

This paper explores how current United States policies for funding nonreproductive cloning are justified and argues against that justification. I show that a common conceptual framework underlies the national prohibition on the use of public funds for cloning research, which I call the simple argument. This argument rests on two premises: that research harming human embryos is unethical and that embryos produced via fertilization are identical to those produced via cloning. In response to the simple argument, I challenge the latter premise. I demonstrate there are important ontological differences between human embryos (produced via fertilization) and clone embryos (produced via cloning). After considering the implications my argument has for the morality of publicly funding cloning for potential therapeutic purposes and potential responses to my position, I conclude that such funding is not only ethically permissible, but also humane national policy.

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Notes

  1. In theory, a human reproduced by cloning would at most have only nearly identical DNA to the nucleus from which it originated because his or her mitochondrial DNA would come from the oocyte used in SCNT, rather than the somatic cell. Additionally, polar bodies and epigenetic mechanisms of inheritance would also influence what genes are expressed as that person develops, creating another source of genetic diversity.

  2. The therapeutic potential of stem cell research (SCR) is extremely controversial and uncertain, and will remain so for the near future. Currently, it is only a theoretical potential, as few randomized controlled trials are underway for stem cell therapies, which would show its actual feasibility. Notably, a biotechnology leader in stem cell research has recently ceased all efforts in the field (Pollack 2011); however, recent preliminary results from another leading company suggest that some patients benefit from therapies derived from SCR (Schwartz et al. 2012). While currently stem cell therapies are unfortunately primarily the province of speculation and unethical treatment (see Enserink 2006), it is possible that with funding, federal oversight, and national and global regulation, ethical therapies could be developed that will benefit many suffering individuals.

  3. The history of politics, philosophy, and embryo research policy during this era is fascinating and worthy of considerations, but beyond the scope of the present discussion. See Riley and Merrill (2005) and Green (2001) for detailed discussions.

  4. The Rabb Doctrine has survived several Federal court challenges and remains in effect today. See Robertson (2010), Cohen and Adashi (2011) and Annas (2011) for recent discussions of the doctrine, this litigation, and its implications for federal funding of stem cell research. The most recent decision affirming the Rabb Doctrine came on August, 24, 2012 (Sherley vs. Sebelius 2012).

  5. Consistent with the view argued for here, the minority recommended a total ban on reproductive cloning and federal regulation of nonreproductive cloning.

  6. One might add another premise to the argument defining what constitutes harm to embryos, such as: To harm a human embryo includes such acts as destroying, discarding, or knowingly subjecting it to certain levels of risk of injury or death, as defined by United States law. For the sake of this analysis such a premise is assumed but suppressed.

  7. It is important, at this point, to clarify a potential ambiguity. As stated here, the simple argument may be ambiguous in terms of how it defines SCNT, in that it could simply mean the singular act of nuclear transfer and none of the steps in the process of cloning that come thereafter. To define SCNT thusly would be to evade the reasons given for opposing it rather than to challenge them. To prevent this interpretation, it should be made clear that by SCNT, I mean not only the act of nuclear transfer, but also the following, discussed in detail below: the preparation of donor cells (removal of nuclei from somatic cell and oocyte), the combination of somatic nucleus and oocyte (nuclear transfer), the activation of the reconstituted oocyte, and the initial divisions of this cell to the clone blastocyst stage, all of which are performed ex vivo. Thus, following a successful act of SCNT, clone embryonic stem cells could in theory be isolated from the inner cell mass of the clone blastocyst and used for the research of cell therapies for transplant and regenerative medicine.

  8. This includes human embryonic stem cells, which will be discussed below, when we consider objections to the argument presented here.

  9. I thank Kathryn Tabb for clarifying the structure of my argument here.

  10. Infamously, a team of researchers led by Hwang Woo-suk first published a report claiming to have successfully performed SCNT in humans in 2005, though this report was later retracted due to scientific misconduct. For citations to the original paper and information on this controversy, see Cho et al. (2006) and the special online section devoted to it by the journal, Science, which originally published the fraudulent research (Science 2011).

  11. While researchers have created stem cells from SCNT produced blastocysts (Noggle et al. 2011), these stem cell lines showed developmental and transcriptional defects (as discussed below). Thus it remains unclear whether such lines are well suited for the purposes of developing novel cellular therapies.

  12. For such detail, see O’Rahilly and Müller (2001).

  13. Following Guenin (2008), I propose to call the product of SCNT a clone embryo, as in a ‘mouse embryo’ or ‘mammalian embryo’. This locution is preferable to a similar one, cloned embryo, because it accurately implies that the embryo is the product of cloning by SCNT, rather than that the embryo is a copy of its progenitor. Saying ‘cloned’ embryo is incorrect because clone embryos contain DNA from both their gametic and somatic sources.

  14. For further discussion of teratoma formation as a marker of embryonic development, see pp. PAGE ## [now 15–16] below.

  15. This argument might be taken as suggesting that the same reasoning holds for embryos produced via IVF, i.e. that they only have, or also have, moral status if and only if they are capable of feeling pain (or as discussed later in this section, have the potential to develop this property). However, this is a misinterpretation of the argument given here. It is assumed that any and all embryos produced via fertilization—i.e., human embryos—have moral status merely by stipulation, which is entailed by the strategy of accepting Premise 2 of the simple argument. The question this analysis targets is whether granting moral status to human embryos entails that clone embryos must also have moral status. Thus, the claim that moral status may be attributed by reference to pain (or later the potential for pain), does not commit us to the claim that it may only be so attributed, or that it is the route by which the products of IVF are said to warrant moral status. I thank an anonymous reviewer for suggesting this worry.

  16. This point may also be raised as regards its application to human embryos produced via IVF. One might wonder, does this mean that left over IVF human embryos also do not have moral status, presuming they are prohibited from enablement, and hence, do not have the chance to develop further to gain the capacity necessary to be attributed moral status? It is important to recognize that by accepting Premise 2 of the simple argument these issues are thereby muted. It is accepted that all human embryos, including those produced by IVF, have moral status. Thus, whether they are unenabled or not, they still have that status, merely by stipulation. Now, important controversies might result from accepting this stipulation, e.g., regarding the morality of freezing or destroying leftover IVF embryos. And, these are no doubt important issues. However, they are not the issues that concern the current argument, which is not about all of the many ethical issues that would follow from accepting for the sake of argument that human embryos have moral status.

  17. As H-W Denker concludes, given contemporary human embryonic stem cell science (not cESC science), this would require taking hESCs and combining them in certain ways with other blastomeres or blastocysts that have themselves been manipulated. Thus, although it is in some sense possible to reconstitute an embryo from some hESC lines, this requires manipulating another human embryo in order to derive the tetraploid helper cells necessary to engineer the initial hESCs to form a complemented human embryo. Though Denker concludes this means hESCs warrant moral protection and perhaps moral status, he is careful to note that this “has not been reported in the literature and does not seem possible” for “somatic cells” ( 2006, p. 669) which are the source of the nucleus of clone embryos and most likely the reason for their insignificant developmental potential. It it is unclear why Denker attributes potentiality (and thus moral status) to the hESCs, rather than the blastomeres that must be manipulated to produced tetraploid helper cells in the experiments he describes. Perhaps this is because related research in mice shows live pups can be produced via tetraploid complementation, though with extremely low efficiency, and in most cases late term and live-birth pups were not healthy (Nagy et al. 1993). Moreover, in these experiments one of the only two healthy pups to reach adulthood was chimeric, i.e., up to 15 % of its somatic DNA originated in the tetraploid embryo used in the procedure to stimulate the mouse ESC. Thus, it remains unclear how to draw the analogy from such mouse models to human beings in a morally significant way, given the genetic and morphological differences between mouse ESCs and hESCs. Nevertheless, as has been discussed above, the developmental potential for human embryos and their derivatives is vastly different than it is for clone embryos, so even if the analogy were clear, such considerations would not apply mutatis mutandis to the case of clone embryos.

  18. One such experiment might be to repeat the experiments done by Noggle et al. (2011) to see whether the zygotic gene activation of hESCs was at all similar to zygotes, parthenotes, or clone embryos, and likewise, to compare these expression patterns to those of cESCs. But of course, first the latter would have to be isolated and reliably cultured, which has yet to be reported.

  19. I thank an anonymous reviewer for suggesting this argument and important scientific literature relevant to it.

  20. See Singer and Dawson (1988) for an expression of this distinction and application of it to embryo experimentation.

  21. Stated thusly, this argument suggests the questions, what threshold for potentiality (possibility) is sufficient to warrant moral status or protection; and likewise, how should we respond to the fact that there is some, albeit only logical, possibility that a clone embryo could develop into a neonate? By distinguishing between logical and nomological possibility, we can appreciate just how low, yet uncertain, these possibilities are, which is an important advance in our accounts of what justifies science-funding policies. Nevertheless, even this minimal possibility suggests that the correct stance regarding funding is one that is cautious, such as using strict, adaptive funding policies that respond to science quickly as we learn more about the entities under discussion (see Mitchell 2009). I thank an anonymous reviewer for posing these important questions.

  22. I thank Jane Maienschein for suggesting this response. It could be stated in a less extreme form that emphasized the contingency of policymaking on many other factors than just philosophical ones.

  23. I thank Mark Wicclair and Douglas White for suggesting this alternative source of justification.

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Cunningham, T.V. What justifies the United States ban on federal funding for nonreproductive cloning?. Med Health Care and Philos 16, 825–841 (2013). https://doi.org/10.1007/s11019-013-9465-5

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