Correspondence
Therapeutic Cloning
N Engl J Med 2002; 347:1619-1622November 14, 2002
- Article
To the Editor:
In the May 16 issue, three articles deal with public policy on stem-cell research.1-3 The authors of all three articles agree that reproductive cloning should be banned but that research on therapeutic cloning (i.e., nuclear transplantation to produce human embryos as sources of stem cells) should be permitted. Annas justifies this compromise politically as the only way to avoid the dangers of unrestrained research.1 Evers thinks that abuses could be prevented if European and other models of regulation were globalized.2 Weissman suggests that scientists are best qualified to make informed decisions on the matter because of their ability to understand fully the potential benefits of scientific and medical research.3
We find these articles seriously inadequate. Each fails to devote sufficient attention to the inevitable death of the human embryo when the embryo's stem cells are harvested. Millions of Americans do not accept the utilitarian argument that the potential benefits of research cloning justify the intentional destruction of the embryo. Yet Weissman and others seek to dispel concern about embryonic sacrifice with the simple protest that preventing embryonic destruction would impede medical research and thereby rob people of the means to improve and prolong their lives.3
Approaches to the formation of public policy that esteem scientific potential but fail to give sufficient weight to all basic ethical considerations are profoundly troubling, and attempts to dismiss those who oppose embryonic destruction simply by pointing to the good that may result are chilling. Although we applaud the desire to pursue therapies for human afflictions, a utilitarian perspective that allows science and medicine to trump ethics in the name of furthering medical benefits is exceedingly dangerous and will eventually have grave consequences. Any serious consideration of the issues raised by research cloning must engage all basic ethical arguments against such a prospect, rather than merely dismiss them or regard them as secondary in importance.
Inclusion in the Journal of material that grapples seriously with the often-neglected ethical issues raised by research cloning would have resulted in a better assessment of this highly contentious topic. The Center for Bioethics and Human Dignity and Georgetown's Center for Clinical Bioethics offer such material4,5 — not to hold back science but to encourage it to proceed in an ethical fashion. Our society must not subjugate basic ethical considerations to scientific and medical progress, lest we all become subjects mastered by our own technological prowess.
5 ReferencesEdmund D. Pellegrino, M.D.
Georgetown University, Washington, DC 20007John F. Kilner, Ph.D.
Center for Bioethics and Human Dignity, Bannockburn, IL 60015Kevin T. FitzGerald, Ph.D.
Georgetown University, Washington, DC 20007Linda K. Bevington, M.A.
Center for Bioethics and Human Dignity, Bannockburn, IL 60015C. Ben Mitchell, Ph.D.
, Highland Park, IL 60035C. Everett Koop, M.D.
C. Everett Koop Institute, Hanover, NH 037551
Annas GJ . Cloning and the U.S. Congress. N Engl J Med 2002;346:1599-1602
Full Text | Web of Science | Medline2
Evers K . European perspectives on therapeutic cloning. N Engl J Med 2002;346:1579-1582
Full Text | Web of Science | Medline3
Weissman IL . Stem cells -- scientific, medical, and political issues. N Engl J Med 2002;346:1576-1579
Full Text | Web of Science | Medline4
CBHD home page. Bannockburn, Ill.: Center for Bioethics and Human Dignity, 2002. (Accessed October 11, 2002, at http://www.cbhd.org.)
5
Edmund Pellegrino's June 2000 testimony before the National Bioethics Advisory Commission. In: Ethical issues in human stem cell research. Vol. 3. Rockville, Md.: National Bioethics Advisory Commission, 2000:F3-F5.
To the Editor:
As a member of the President's Council on Bioethics, I wish to note several problems with Dr. Weissman's treatment of the moral questions involved in research cloning. My comments are mine alone and are not made in the name of the council or its other members. First, as he did in his testimony before the council, Dr. Weissman makes wide-ranging claims about the nature of moral responsibility, especially responsibility for suffering if one opposes research cloning. These assertions are lacking in the complexities of moral theory.
Second, the attempt to characterize research cloning as the entirely different act of nuclear transplantation to produce stem cells is an astonishing example of what we try to teach students to avoid: winning arguments by manipulation of language. In his testimony before the council, Dr. Weissman was unable to defend this language in the face of critical questions, and it ill behooves one who is willing to manipulate language to wrap himself in the cloak of “objectivity.”
Finally, I, for example, have no financial stake in this argument. Whether research cloning is permitted or prohibited will make absolutely no difference to my personal income. Those who cannot say the same are perhaps not in a position to lecture others on the moral meaning of objectivity.
Gilbert Meilaender, Ph.D.
Valparaiso University, Valparaiso, IN 46383
gilbert.meilaender@valpo. edu To the Editor:
Annas says, “If no bill is enacted, cloning will remain unregulated.” We may first observe that good moral reasons obtain for allowing nonprocreative cloning.1 We may also observe that the Food and Drug Administration (FDA) has given force to a scientific consensus by declaring that “clinical research using cloning technology to clone a human being” may not proceed without an investigational-new-drug application, and that, given “unresolved safety questions,” the FDA “would not permit any such investigation to proceed.”2 Notified of the FDA's policy, even mavericks have forsaken procreative cloning within U.S. borders. Someone might argue that the “cellular products” espied by the FDA in procreative cloning are not “biological products” or “drugs,” and that the FDA therefore lacks jurisdiction, but unless a court adopts that argument, anyone who attempts procreative cloning risks prosecution.3 Hence the likely incidence of procreative cloning by U.S. providers seems nil.
It is possible to imagine the emergence of procreative cloning technology that the FDA does not deem unsafe. In that event, a legislative ban would not be superfluous. But neither would a ban's justification be obvious. To beget a child is the quintessential liberty protected from governmental intrusion by the constitutional right of privacy. The proponent of a ban implies that even if other instances of impregnation are private in the sense of inviolable, cloning is not. The proponent's burden would be to adduce convincing nonsafety reasons — thus far we have heard mostly genetic deterministic and other speculations about clones' lives — that warrant this view of privacy.
3 ReferencesLouis M. Guenin
Harvard Medical School, Boston, MA 02115
guenin@hms.harvard. edu 1
Guenin LM. Testimony before Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives, June 20, 2001. (Accessed October 24, 2002, at http://energycommerce.house.gov/107/hearings/06202001Hearing291/Guenin452.htm.)
2
Zoon KC. Letter to associations — cloning technologies. Rockville, Md.: FDA Center for Biologics Evaluation and Research, March 28, 2001. (Accessed October 24, 2002, at http://www.fda.gov/cber/ltr/aaclone.htm.)
3
FDA Associate Commissioner for Legislation. Letter to Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, May 18, 2001.
To the Editor:
Dr. Evers's review of European perspectives on therapeutic cloning gives the impression that the United Kingdom's controls are wholly based on the opinions of national ethics committees or research councils. This is incorrect. The United Kingdom has one of the most comprehensive sets of legislation on this matter in the world.
All human-embryo research is regulated by the Human Fertilisation and Embryology Authority under the Human Fertilisation and Embryology Act 1990. Such research is permitted only for the purposes set out in the 1990 act and then only if strict conditions are met and a license has been issued by the Human Fertilisation and Embryology Authority.
In August 2000, my expert group issued its report on stem-cell research.1 The government of the United Kingdom subsequently introduced legislation — the Human Fertilisation and Embryology (Research Purposes) Regulations 2001 — in order to extend the permitted purposes of human-embryo research to include research into serious diseases.
Last year, the government of the United Kingdom specifically banned human reproductive cloning with the Human Reproductive Cloning Act 2001. It is now a criminal offense, punishable by up to 10 years in prison or an unlimited fine, to place in a woman an embryo created by any means other than fertilization.
The strong regulatory system in the United Kingdom, based on many years of discussion of the ethical issues, provides an appropriate balance, allowing medicine to gain the potential benefits of this technology while preventing its abuse through legislation.
1 ReferencesLiam Donaldson, M.D.
Department of Health, London SW1A 2NS, United Kingdom
liam.donaldson@doh. gsi. gov. uk To the Editor:
Evers writes, “It is a fundamental tenet in many European cultures that humans shall not be treated merely as the means to an end but also as ends in themselves.” I do not know of any Western culture where humans do not always have to be treated as ends in themselves. Under some special circumstances, humans are being abused as the means to an end, and some people accept the treatment of humans as such for a presumptive higher goal.
Concerning the issue of protection from abuse, Evers writes, “In order for such a regulation to be more than yet another . . . toothless declaration, the rules must be backed up by an internationally representative body with the mandate to issue sanctions.” If science is to wait for this to happen before cloning commences — which is a sine qua non according to Evers — there is no need to be afraid. History teaches that this will never be the case.
Thomas M. Schenk, M.D.
University Hospital of Vienna, A-1090 Vienna, Austria
thomas.schenk@nextra. at Author/Editor Response
Dr. Weissman replies:
To the Editor: Pellegrino et al. claim that in my article on stem-cell research, I “suggest that scientists are best qualified to make informed decisions on the matter. . . .” I do not. I suggest that all parties in the debate should be sure of their facts, and I present four kinds of research that could not be done with the 64 approved human embryonic stem-cell lines or adult stem cells. There are many ways to view the relevant ethical, moral, political, legal, and religious issues. I say so in my Sounding Board article1 and in the National Academies Panel I report.2 In a pluralistic society, these issues need to be debated, especially when used for the determination of policy. But when groups make scientific and medical claims that are misleading, we have the obligation to clarify the facts. For example, the group Do No Harm, which includes Dr. FitzGerald, wrote to National Institutes of Health Director Ruth Kirschstein to state its opposition to human nuclear transfer, citing 228 reports on studies showing that adult stem cells of one tissue type could transdifferentiate to tissue of another type. None of the studies began with known human stem cells and proved transdifferentiation.
I recognize that my opinions outside my scientific and medical expertise are no better and no worse than those of any other self-described bioethicist. I presented information about the medical and scientific issues largely ignored in this debate. What if we had banned recombinant-DNA research because many bioethicists believed it was not our right to create a new form of life? By now thousands of patients have benefited from the products of that research.
Meilaender claims from his position as a moral philosopher and theologian that I would not pass muster in his field but cites no specific examples of my failures. It is clear that he is using arguments only about me, not about the issues. I did not make wide-ranging claims about the nature of moral responsibility, especially responsibility for suffering if one opposes research cloning, nor did I manipulate the language beyond the accepted terminology of two independent panels of the National Academies. My comments concerned the scientific and medical aspects of these issues, and I tried to point out what would be lost if a research ban were imposed. I refer readers to the transcripts of my testimony to the President's Council on Bioethics to judge the merits of the arguments and facts. Finally, as I disclosed to Meilaender and the council, if research cloning is permitted, it will not increase my personal income; I have interests only in adult-stem-cell companies.
2 ReferencesIrving L. Weissman, M.D.
Stanford University School of Medicine, Stanford, CA 94305-5323
irv@stanford.edu 1
Weissman IL . Stem cells -- scientific, medical, and political issues. N Engl J Med 2002;346:1576-1579
Full Text | Web of Science | Medline2
Committee on Science, Engineering, and Public Policy. Scientific and medical aspects of human reproductive cloning. Washington, D.C.: National Academy Press, 2002.
Author/Editor Response
Dr. Evers replies:
To the Editor: Pellegrino et al. warn that societies should not “subjugate basic ethical considerations to scientific and medical progress” and “allow science and medicine to trump ethics in the name of furthering medical benefits.” I am not under the impression that any of the articles discussed recommends any such thing. From their different viewpoints, the articles suggest that it may be more ethical to proceed with therapeutic cloning than not to proceed with it. In so doing, they put forward various ethical arguments, which is not to trump ethics. Pellegrino et al. may not agree with these arguments, but they fail to offer substantial objections from which an interesting discussion could ensue. They use emotionally laden expressions such as “embryonic sacrifice” with “chilling” results and refer to “grave consequences” that are “exceedingly dangerous” and unacceptable to “millions of Americans,” but no further details are provided. It is important to remember that in order to ensure that science and medicine proceed in an ethical manner, ethics must be based on sound, substantial, and rational arguments.
Kathinka Evers, Ph.D.
International Council for Science Standing Committee on Responsibility and Ethics in Science, 0105 Oslo, Norway
evers@online.no Author/Editor Response
Professor Annas replies:
To the Editor: The key point made in my article was that enacting legislation on cloning in the United States would politically require treating the use of research cloning to make drugs differently from the use of asexual reproductive cloning to make children. The President's Council on Bioethics has since also come to this conclusion, with the majority of the council recommending a ban on reproductive cloning but only a moratorium on research cloning.1 President George W. Bush has not yet commented publicly on his council's recommendation. None of the competing bills outlined in my article reached the floor of the U.S. Senate this summer, and even if the President strongly encourages a compromise along the lines suggested by his Council on Bioethics, no cloning law is likely to be enacted this year.
Guenin apparently disagrees that this leaves reproductive cloning unregulated, because he thinks the FDA has jurisdiction over it. I think he is wrong about this, for three reasons. First, babies are not medicine, drugs or devices, or even “cellular products,” and the FDA has no jurisdiction over either human reproduction or the practice of medicine. Second, the FDA, as its foray into tobacco regulation demonstrates, does not obtain jurisdiction simply by asserting it. Third, there is no practical way to separate safety from efficacy in reproductive cloning: tests of both would require the birth of a cloned child. Rules for phase 1 drug-safety trials have no meaning in the context of human reproduction. You can inject a small amount of an investigational drug; you cannot be just a little pregnant.
Finally, Guenin's suggestion that reproductive cloning would be constitutionally protected if the FDA found it safe is unpersuasive not only because safety could never be ethically demonstrated, but also because asexual reproduction is so different from sexual reproduction that the U.S. Constitution need not protect it, even though the Constitution continues to protect sexual reproduction.2 Those who want to protect children by outlawing asexual human reproductive cloning are not the genetic determinists; rather the determinists are those who believe that the only child likely to be worthy of their aspirations is a genetic duplicate of an existing person.
I agree with Pellegrino et al. that their ethical arguments deserve serious consideration. But agreement with them would require, among other things, that in vitro fertilization itself be banned, at least unless no “spare embryos” were created that might ultimately be destroyed. I think this goes too far and, like the majority of the President's Council on Bioethics, cannot agree that human embryos must be treated the same as human children.1 Protecting children, however, does require an effective international treaty banning human reproductive cloning, and the United States will have to outlaw reproductive cloning before it can assume a leadership role in this effort.2
2 ReferencesGeorge J. Annas, J.D., M.P.H.
Boston University School of Public Health, Boston, MA 02118
annasgj@bu.edu 1
Human cloning and human dignity: an ethical inquiry. Washington, D.C.: President's Council on Bioethics, July 2002. (Accessed October 24, 2002, at http://www.bioethics.gov/cloningreport/.)
2
Annas GJ ,Andrews LB ,Isasi RM . Protecting the endangered human: toward an international treaty prohibiting cloning and inheritable alterations. Am J Law Med 2002;28:151-178
Web of Science | Medline
