SECTION: CAPITOL HILL HEARING TESTIMONY

LENGTH: 4396 words

COMMITTEE: HOUSE JUDICIARY

SUBCOMMITTEE: CRIME

HEADLINE: HUMAN CLONING BAN

TESTIMONY-BY: ALEXANDER MORGAN CAPRON LL.B, COMMISSIONER

AFFILIATION: NATIONAL BIOETHICS ADVISORY COMMISSION

BODY:
June 19, 2001

Statement of

Alexander Morgan Capron, LL.B. Speaking first as: Commissioner National Bioethics Advisory Commission And then speaking on his own behalf as: Henry W. Bruce Professor of Law University Professor of Law and Medicine Co-Director, Pacific Center for Health Policy and Ethics University of Southern California Law Center

Before the Subcommittee on Crime Committee on the Judiciary United States House of Representatives

As Commissioner, National Bioethics Advisory Commission

Thank you, Mr. Chairman. I am Alexander Capron, and I have been invited to testify before the Subcommittee in two capacities today: as a member of the National Bioethics Advisory Commission (NBAC) and as an expert on legal issues in bioethics. In this statement, I summarize relevant conclusion of the Commission, and in a separate statement I present my personal views.

NBAC was chartered by President Clinton in 1995 and began work on October 4, 1996. It studies ethical issues arising from biomedical and behavioral research and makes recommendations to the President, the National Science and Technology Council, and others. My fellow commissioners include physicians, theologians, ethicists, scientists, and lawyers, psychologists, and members of the general public. On February 24, 1997, the day that the American news media reported that scientists in Scotland had succeeded in cloning an adult mammal for the first time, President Clinton asked NBAC to examine the serious ethical questions raised by A possible use of this technology to clone human beings. NBAC immediately undertook an intensive and open examination of the topic, hearing from experts in law, science, medicine, ethics, religion as well as from members of the general public. A little more than three months later, we submitted our report, Cloning Human Beings, to the President.

NBAC focused on a very specific aspect of cloning, namely where genetic material would be transferred from the nucleus of a somatic cell of another human being, living or dead, to an enucleated human egg with the intention of creating a child. We did not revisit issues raised by human cloning by embryo- splitting in fertility clinics: only cloning through the new somatic cell nuclear transfer (SCNT) technique. We examined only A reproductive cloning, not research cloning, the creation of embryos which would not be implanted in a uterus.

The Commission discovered that the potential ability to clone human beings through SCNT raises a host of complex scientific, religious, legal, and ethical issues-some new and some old. Especially noteworthy were the medical risks to any child conceived in this manner, as well as the diversity of views that we heard among religious scholars, indeed even among those within the same religious tradition.

The Commission concluded that no one-whether federally or privately supported-should be permitted to create babies through cloning at this time. To this end, we recommended that a moratorium be imposed on such research. A moratorium gives society a safeguard not only against the extreme risks to any child created in this fashion but also against the possible harms that might accompany crossing the line to controlled, asexual reproduction moratorium also provides a period of time both for further knowledge to be accumulated about mammalian cloning and for serious and sustained reflection about the sort of world that human cloning could create. Then, say three to five years hence, Congress and the President would need to decide whether the results of the scientific research and of the debate on the risks and potential benefits of human cloning had provided sufficiently strong reasons to lift the prohibition and permit human cloning under any circumstances.

Because our Cloning report was prepared in a relatively short period of time, and when the technology was still in its infancy, we made no attempt to write the final word but instead provided a starting point for what we hoped would be the profound and sustained reflection our Nation needs on the subject of human cloning.

While the commission has not deliberated any further on this topic since submitting the Cloning report to President Clinton in June 1997, our main conclusions still stand. Indeed, in a letter to President Bush on March 16, 2001, NBAC Chair, Harold T. Shapiro, stated:

While we did not resolve all of those [ethical] issues, we unanimously concluded that given the current state of the science, any attempt to create a human being through somatic cell nuclear transfer would be terribly premature and unacceptably dangerous. Besides being morally unacceptable on safety grounds, the creation of human clones would involve risks to the children- and more broadly to society-that are serious enough to merit further reflection and deliberation before this line of research goes forward.

Issues relating to cloning emerged again with the announcement in November 1998 that researchers at the University of Wisconsin and Johns Hopkins University had for the first time succeeded in creating human pluripotent stem cell lines from embryos remaining after infertility treatments and aborted fetuses. President Clinton requested that NBAC also review the issues associated with that research. Again, the commission heard testimony from a wide range of experts and commentators as well as the public. After many months of public deliberation we concluded in our report Ethical Issues in Human Stem Cell Research that changes should be made in statutes and regulations to allow federal funding of research involving the derivation and use of human stem cells from aborted fetuses and from embryos that would otherwise be discarded, subject to appropriate ethical standards and procedures that include public oversight and review.

In that report, the commission recommended that research involving the derivation or use of stem cells from human embryos made using SCNT should not be eligible for federal funding at this time. However, NBAC noted that there was significant reason to believe that use of stem cells from such embryos may have therapeutic potential, due to the utility of matched tissue for autologous cell replacement therapy, and stated that scientific progress and medical utility in this area of research should be monitored closely. NBAC did not address whether or not this research should occur in the private sector.

At the time it considered the question of cloning, NBAC had several courses of action under consideration. One would have been no moratorium on any activities. The second would have been a moratorium on both reproductive as well as research cloning. The third, which is the one that the commission actually chose, was a temporary moratorium on reproductive cloning, but no moratorium on research cloning. In so doing, NBAC recognized that while important moral considerations are at stake, with respect to research and reproductive cloning, the nature of those moral considerations are different in kind. With respect to research cloning, the issues are those associated, in general, with the embryo research debate. With respect to reproductive cloning, however, the issues pertain to the safety of the fetus and mother and the potential impact of reproductive cloning on the resultant children and our institutions of parenting and child bearing. It was because of the difference between these types of considerations that a moratorium was considered appropriate in one case (reproductive cloning) but not the other (research cloning). At the time it considered stem cell research, the commission once again considered the question of research cloning. Here it concluded that the case had not yet been made for a need for federal funding for this activity. It did not, however, propose a moratorium on privately funded activity in this area.

Those are the recommendations of NBAC. While I suspect that the commissioners hold a range of views on the consequences to society of the development and use of SCNT to create children, all of us-like the overwhelming majority of Americans-agree that those consequences would be profound; and further, that the risks have not yet been adequately explored, much less carefully balanced against competing interests, whatever they might be.

As Co-Director, Pacific Center for Health Policy and Ethics, University of Southern California

I will now state my own understanding of NBACs reports, but my views are my own, and I am aware that they do not reflect those of all my fellow commissioners.

One of the bills before you, H.R. 1644 . The Human Cloning Prohibition Act of 2001, would permanently prohibit the use of SCNT to create human embryos for any purpose, including reproductive cloning and the creation of embryos as a source of embryonic stem cells. NBAC did not directly address one of the questions that is before this Committee, namely, whether the control of reproductive cloning requires controlling the creation of embryos by SCNT for research purposes. It is my opinion, however, that our Cloning report-when read in light of subsequent developments in that field and of the Stem Cell report-supports completely halting all attempts to create human embryos through SCNT at this time.

Obviously, the most contentious issue in H.R. 1644 is the prohibition on the use of SCNT to create cloned embryos from which stem cells of a predetermined genetic background could be derived. Though often labeled Atherapeutic cloning because of the hope that someday such cells could then be used to generate cells, tissues, or even whole organs for transplantation, I believe the term research cloning is more accurate. As NBAC recognized in Cloning Human Beings, an essential step before the label Atherapeutic would even possibly be appropriate would be for scientists to understand how to direct cellular differentiation along a specific path to produce the desired material for transplantation: Given current uncertainties about the feasibility of this, however, much research would be needed in animal systems before it would be scientifically sound, and therefore potentially morally acceptable, to go forward with this approach (p. 30).

We reinforced and expanded on this conclusion in the Stem Cell report. Although limited to the question of federal funding, I believe that report has wider implications, because we favored such funding not only to help ensure that the federal government would be in a position to set ethical standards to guide all researchers in this field but also because we felt that serious public detriment would be arise from leaving the development of science in this field entirely to private, and often commercial, researchers while excluding scientists at federal institutes (such as the NIH) and those conducting studies with federal support.

Had a stronger justification been shown for using SCNT to create embryos for stem cell research, I do not believe that we would have opposed federal funding. The need for cloning human embryos was simply not established, given the rudimentary state of the science on such matters as mammalian cloning in general or controlling the differentiation and development of cells and organs from pluripotent stems cells. In addition, NBAC recognized the availability of human embryos remaining after fertility treatments to meet the needs of researchers. In my opinion, that picture has not improved in the subsequent 21 months. If anything, the arguments for emphasizing basic research with nonhuman stem cells is even greater in light, for example, of the sad results involving unregulated cellular activity in the brains of some Parkinson-s patients who received fetal tissue transplants in experiments in New York and Colorado. Furthermore, the problems with development of the few cloned animals that have survived to birth provide a warning signal that we cannot simply assume that stem cells generated from cloned human embryos would themselves function normally.

Not only are we years away from having a good basis for using cloned embryos for Atherapeutic research on human patient- subjects, but other avenues are being pursued that might mean that cloned embryos will never be needed to achieve good results in transplantation. First, scientists are investigating whether embryonic stem cells are, as some believe, less likely to stimulate rejection following transplantation. If that proves to be the case, transplantation could be performed using tissues and organs derived from existing cell lines without having to produce cells that are clonally identical to transplant patients. Second, promising laboratory work on adult stem cells harvested from a number of tissues offers the prospect of achieving autologous cellular therapy and transplantation without the need for cloned embryonic stem cells.

In light of the ethical and moral concerns raised by the use of human embryos for research, NBAC concluded that It would be far more desirable to explore the direct use of human cells of adult origin to produce specialized cells or tissues for transplantation into patients, though we noted that the possible use of adult stem cells will be greatly aided by an understanding of how stem cells are established during embryogenesis (Cloning Human Beings, p. 31). Thus, while such research with adult cells does not obviate the need for research with embryonic stem cells, all these lines of research-including research in animals-have much further to go before questions arise that can only be answered through the creation of human embryonic stem cells cloned through SCNT.

I have already mentioned the NBAC Cloning report recommended a prohibition on human reproductive cloning, but only for a time period of three to five years, after which time Congress and the President should revisit the issue and decide whether the prohibition would stay in place. H.R. 1644 includes a permanent prohibition on all SCNT. For myself, I would be comfortable with the bill as written, namely that the ban on reproductive cloning (but not research cloning) not be time-limited. Many reasons have been offered by those who favor cloning, from the wish to create a copy of oneself or of another esteemed person to the desire to replicate a deceased relative (particularly a child) to simply having an alternative means of reproduction, whether as a means of overcoming infertility or otherwise. None of these reasons seem compelling to me. Beyond the risk of physical harm to child and perhaps to mother, cloning poses potential psychological and social harm to the children produced by this technology. More fundamentally, the use of cloning to produce children would not merely be the ultimate form of eugenics but an alteration of the basic relationship between generations. In the context of other means of genetic manipulation-indeed, the very means that Dollys makers had in mind in developing SCNT in mammals, namely the creation of large numbers of animals whose genotype had been modified to produce a desired phenotype-allowing reproductive cloning would be the decisive step toward the Brave New World. Since I do not think that such a state of affairs would advance the Amore perfect Union enshrined as the aspiration of the American people for more than 200 years, I would have no problem with going further than NBAC went, enacting the prohibition now and leaving to those who would so radically alter the manner in which human beings are created the burden of showing that the benefits clearly outweigh the risks.

It does seem to me, however, that the idea of a moratorium-that is, a time-limited ban-can be usefully applied to the second activity addressed by H.R. 1644, namely the creation of cloned embryos for research purposes. NBAC did not recommend the use of federal funds to support creation of cloned embryos for research at this time. Although NBAC did not recommend a prohibition in the private sector, I have already explained why I think our recommendations can (though need not) be read more broadly to suggest that this area of research should not be pursued by anyone at this time. Thus, it seems fair to me to read Recommendation 4 in our Stem Cell report as consistent with prohibiting efforts to use SCNT to create human embryos for research purposes at this time. I personally agree with the premise of H.R. 1644 that the best (probably the only) way to stop what we all think should be stopped-namely reproductive cloning-is to impose a moratorium on research cloning as well. Producing normal human embryos through cloning is probably going to be a challenge, but once such embryos are on hand (available in laboratories and perhaps even as items of commerce) I believe it will prove impossible to prevent efforts to implant them and achieve a pregnancy behind the privacy veil of the physician- patient relationship. The slope here is slippery not just because the step may be taken surreptitiously but because the slide downward will be accelerated by contradictory ethical imperatives. On the one hand, once the cloned embryos have been created, some who oppose reproductive cloning will feel so strongly that the embryos have a right to life that they will insist that the embryos be used to attempt to achieve a pregnancy. On the other hand, once a pregnancy has been established defenders of womens right to control their own reproduction-including those who are appalled by reproductive cloning-would be as loathe as any anti-abortionist to tell a woman carrying a cloned fetus that she must abort it.

Thus, any serious effort to stop asexual reproduction needs in my opinion to encompass all efforts to create cloned embryos. I believe that placing research cloning off-limits at this time is fully consistent with NBACs recommendation that such research not go forward now with federal funding because much more work needs to be done in the basic science as well as with adult and noncloned embryonic stem cells before we can possibly know whether the cloning of embryos offers the only means of achieving a potentially life-saving therapy for certain patients.

A moratorium may not initially appeal to anyone who believes that it is always wrong to create, much less to destroy, a human embryo for research or therapy unconnected with that embryos own well-being. Yet to these people, I would say that a moratorium achieves the very end that they seek, which is to forbid the creation of cloned embryos. Conversely, for those who do not take that view, a moratorium carries the promise that the issue of research with cloned embryos will be revisited. Just as NBAC favored a moratorium on reproductive cloning so that the issue could be reconsidered, so too Section 4 of H.R. 1644 says that the National Bioethics Advisory Commission or a successor group will study and report back within five years on the need (if any) for human cloning to produce medical advances as well as the possible impact of permitting research cloning upon efforts to prevent human cloning for reproductive purposes. Again, I want to stress that the commissioners did not directly face or decide this particular question, but they did agree with the objective of forestalling the cloning of human babies and that grounds for cloning human embryos at this time are not so strong that federally funded scientists need to conduct such research.

A moratorium was accepted by biomedical researchers 27 years ago, at the dawn of the era of genetic engineering, when leading scientists recognized the unpredictable risks associated with some of the experiments and persuaded the community to halt them until the risks could be better assessed and appropriate preventive measures adopted. Last year, on the 25th anniversary of the famous silomar meeting that was held to decide whether and how the moratorium should be lifted, I chaired a symposium back at Asilomar in which 50 scientists, social scientists, ethicists, lawyers, government officials, and journalists examined that earlier moratorium and its continuing relevance today. In some ways, the decision to halt work was more difficult a quarter of a century ago because some of what was stopped was the next logical step in research and was being actively pursued by the leading scientists, which is not true of cloning human embryos today. Yet in other ways, the gene splicing moratorium was easier to accomplish because the risks to be avoided were immediate, physical harms, from injuries to laboratory personnel to potential epidemics of novel pathogens, whereas the ethical and social issues that really underlay the publics concern (and that are the category of risks that arise from human cloning) were not debated at Asilomar. Moreover, as we concluded at the symposium in February 2000, the commercialization of biotechnology has changed the pressures to pursue research as well as the freedom of scientists and their credibility in calling for a halt to research. Thus, while a moratorium-putting some research out of bounds while its risks can be assessed and possible safeguards can be developed-is something that biomedical researchers have accepted in the past, the impetus for a moratorium on human embryo cloning probably now must come from the government.

Researchers must be assured that the moratorium will not prevent other lines of research, either on stem cells not derived from cloned embryos or the cloning of molecules, cells, or the like that does not involve embryos. H.R. 1644 seems to me to accomplish this objective. That leaves the question of whether the moratorium should be framed as a sunset provision that lets the prohibition lapse if not renewed or as ban that remains in place after the mandatory review unless reversed by a majority. Reasonable people may differ on this point, but given both the importance of the subject and the confidence with which biotechnologists predict that the creation of cells from cloned embryos will provide benefits not otherwise available, I conclude that the burden of proof should be left with the proponents of the research when the ban is reconsidered. If they have arrived at the point where the use of cloned embryos offers a means of achieving a life-saving therapy that has been found to be otherwise unobtainable, then I believe they will persuade a majority of people that such steps should be allowed under the most stringent of ethical and practical safeguards.

Agreeing on this course will require each side to compromise. It would seem to me-if I may be so bold, and speaking as a citizen and a person concerned with the ethical and policy implications of science and medicine rather than as a member of NBAC-that this is one time that people on both sides of the aisle should do all they can to avoid allowing their disagreements on other matters, such as abortion and stem cell research, to stand in the way of a compromise that achieves the central aim that is overwhelmingly supported-and rightly so-by the American people, and indeed, by most people around the world.

I hope that these hearings can help promote a genuine dialogue among people holding a range of views on the subject and that a compromise, perhaps along the lines I have urged here, can be forged. In recommending a moratorium on reproductive cloning, NBAC hoped that during the period of three to five years before the issue was reconsidered in Congress, our Nation would engage in A profound and sustained reflection on the issues. Regrettably, four years to the month after we submitted our report, this sort of serious, broadly based public discussion has yet to occur. Partisan disputes have prevented Congress from acting even though it appears that there is overwhelming agreement here that reproductive cloning should not be allowed at this time, And while a good deal of academic debate has occurred, as time has passed the press seems to have found the topic too weighty for continued public scrutiny. Hence, the plans announced by various groups in recent months to develop reproductive cloning are today more often the objects of comedians humor than commentators analysis. Indeed, from the tone of the inquiries I have had lately from reporters and from some (though certainly not all) of the media coverage, I sense that the simple familiarity of the topic has served to trivialize it. The initial reaction of many people to the technology and to the prospect of its being applied to human beings-disbelief and repugnance-has been replaced by disinterest. As one reporter said to me recently, Doesn-t cloning seem more acceptable now? After all, despite the original objections, nothing bad has happened, has it? Well, of course not, because as far as we know, no one (thankfully) has yet tried to clone a human baby. Yet the risk of that happening is great if the serious problems with such a step are not brought before the public and if legislation is not adopted to make clear that no one may take such a step at this time.

In conclusion, I want to return to Chairman Shapiros March 16 letter to President Bush, in which he stressed how seriously the present, announced efforts to engage in human cloning ought to be taken. He also stated that adopting a moratorium would bring the United States into line with the position adopted by the Council of Europe and would encourage other nations to do likewise. As recommended by the G8 nations at the Denver Summit, and as emphasized in a number of the bills pending before Congress (including H.R. 1644), international cooperation is going to be essential for success. Humankind stands now at an historic juncture. When our descendants-and I do hope they are truly our descendants, not our manufactured replicants-look back to this time, let them find that we were equal to what I think may fairly be labeled an unprecedented challenge. In my view, the United States should take the lead in protecting our human future by locking the barn door now on reproductive cloning and by persuading other nations that at this time a ban on the cloning of human embryos represents the best way to ensure that the cows stay in the barn.

Thank you for the opportunity to present my views on this subject, and I am happy to answer any questions that you may have.



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