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ETHICAL ISSUES IN GENETICS

by THOMAS A. SHANNON

PRIVACY

THREE TYPES of privacy have been identified: physical (freedom from physical contact), informational (which limits access to information about one's self), and decisional (the capacity to make decisions for one's self).(1) All are impacted by both genetic testing and various forms of prenatal diagnosis.(2) While the means of diagnosis are minimally invasive physically (a drop of blood or a single strand of hair is enough), obtaining such samples can constitute invasions of physical privacy. To learn whether there is a genetic component to a disease, elaborate family pedigrees must be constructed. Knowledge that one family member has a genetic predisposition for a disease has implications for other family members. If screening is a precondition for either insurance or employment, substantive privacy and social issues are raised. While insurance companies already screen potential customers through physical exams, some fear that genetic screening will also be required either through direct testing or the disclosing of previously taken tests.(3) Thus individuals with a genetic disposition for breast cancer may be uninsurable because of the financial loss they represent to a company. Employers too have an interest in learning the genetic profiles of present or potential employees, but access to such information can violate both informational and decisional privacy.(4) While issues of discrimination and paternalism can arise in companies' employment policies, nonetheless some employees could be at risk because of certain jobs. While rectifying the environment is certainly one way to help resolve this, individuals still remain sensitive to certain pollutants. Public-policy issues for these agenda have not been resolved. Because genetic information is both private and social, we are only beginning to realize the impact that genetic screening will have on our traditional understanding of privacy and confidentiality.

Similar issues arise in prenatal diagnosis(5) that makes the health status of the fetus immediately accessible and visible, and thus available to insurance companies. This potentially compromises both the confidentiality of such information and the mother's decisional privacy by limiting her range of options, especially if the insurance company determines that the condition of the fetus is a preexisting one and will provide no reimbursement for medical care.

RISK-BENEFIT ANALYSIS

Risk-benefit analysis is a traditional way of deciding whether or not to undergo a particular procedure. While offering the promise of many benefits, new genetic interventions also present a new range of risks.(6) A new issue is learning that one may be susceptible to a disease which will occur later in life, such as breast cancer or Huntington's disease; thus the term "presymptomatic disease."(7)

Because no therapies are yet available other than perhaps a drastic treatment such as prophylactic mastectomy and oophorectomy, some question the value of such information.(8) A particular problem is identifying the predisposition for a disease with the actual disease, which causes additional suffering for the individual as well as possibly disqualifying them for insurance. Another problematic category is the screening of young children and adolescents. The issue of informed consent is particularly difficult, especially when the minor is becoming mature but nothing can be done to treat the disease. Issues of self-esteem, stigmatization, and complex familial relations are of concern, to say nothing of the previously discussed insurance difficulties.(9)

Another dimension of the risk-benefit problems related to genetic testing (and screening) is the accuracy of the test itself as well as the number of false positives and false negatives it produces. While these are primarily technical questions related to the test itself, they also raise profound ethical questions: When should a test be made available? Is the test applied to all of the possible genes associated with a disease or only the more common sites tested (e.g., with cystic fibrosis, there are over 300 mutations which can cause cystic fibrosis, but typically about 60 to 70 sites are tested)? How expensive will the test be? Will the number of false positives or false negatives cause more harm than not making the test available?

Two important facts must be kept in mind in evaluating or using any genetic testing technologies. First, while literally thousands of genetic anomalies can be detected, we understand the health implications of only few of them. Second, we cannot cure any of the genetic anomalies that we detect. These two hard realities frame any ethical discussion, particularly discussions of late onset genetic diseases such as breast cancer. While some interventions can be made that alleviate some symptoms, or the information can be used to prepare families for what is to come, precious little can be done about the disease itself. Thus the choices are poor: either to avoid reproduction, to use donor sperm or egg, to abort, or to continue the pregnancy with the disease running its natural course. If the last option is chosen, little insurance and few social resources will be available to care for the child.

While prenatal diagnosis is offered typically to women in higher risk categories (women with a history of genetic disease or over 35 years of age(10)) and while only about two percent of such diagnoses lead to potential abortion, nonetheless prenatal diagnosis will become more common. First, as new genetic discoveries are announced, pressure will increase to detect these as early as possible. Second, given the current malpractice climate, prenatal diagnosis becomes a means of defensive medicine. Third, as childbearing is being delayed until later--with infertility increasing--and as people are having fewer children, pressure builds to have as healthy a child as possible.

Although one's child might have a so-called normal genome, that in itself does not mean that the child will be healthy, never contract a fatal disease, or have a pleasant personality. Genetic screening can raise expectations that cannot be met and unwittingly open the door to a new kind of eugenics, family eugenics. In this case the couple selects a genetic profile in the expectation of obtaining a certain type of child. Since currently one can already order somewhat custom-designed embryos, this application is not far fetched.(11) Prenatal diagnosis may be setting up a situation in which children are desired for specific characteristics, not for who they are.

All of these issues surrounding prenatal diagnosis raise this critical question: What is the problem that prenatal diagnosis is meant to solve?

On the benefit side of the equation is the developing use of human gene transfer.(12) The first intervention is somatic cell therapy, which has three forms: (1) ex vivo, in which cells are removed from the body, corrected, and then returned so that the new function can be expressed and correct the disease; (2) in situ, in which the new gene is directly introduced into the locus of the disease; and (3) in vivo, in which the therapeutic gene is injected into the bloodstream and travels to the proper tissue.(13) The second intervention is germ line therapy, which corrects an anomaly by placing the corrected copy in the germ cells in the fertilized egg; this both corrects the condition for the individual and also allows the correct copy to be passed on to one's descendent.

In general, the ethical analysis of somatic cell gene therapy follows in broad outline an analysis similar to that of the introduction of any new medical therapy. Walters and Palmer identify seven key questions. (1) What disease is to be treated? (2) Are there alternative forms of therapy, and are they affordable? (3) What are the anticipated or potential harms of the therapy? For example, will the virus used to transport the new genetic material become reactivated and cause harm, will the new genetic material reach the correct part of the cell, will there be any harmful long-term effects? (4) What are the expected or anticipated benefits? (5) Will patients be selected fairly? Children had traditionally been protected by not being included in research projects, but current thinking is that no group should be excluded from research, particularly if gene therapy can be potentially more beneficial when introduced earlier. (6) How will informed consent be ensured? While this question is critical for the adult population who may be desperate for a potentially life-saving therapy, it is also critical for children whose parents may frantically desire to save their children. (7) How will privacy and confidentially be preserved? Given the highly experimental nature of this research, its inherent newsworthiness, as well as the penchant for feeding frenzies on the part of the media, such concerns are not academic. Yet the identity of the two children who were the first subjects of gene therapy was kept confidential for over a year and eventually released only with the parents' permission.(14)

Three key ethical questions are: (1) How quickly should gene therapy move to clinical practice? Should a particular therapy prove successful, there will be tremendous pressure to move it from the laboratory to the bedside as soon as possible. But we need to remember that the critical ethical variable here is that the therapy must be proven to work and to have at least no negative short-term side-effects. (2) How efficacious or successful is the therapy? From 1990 to 1995, 100 clinical trials of gene therapy were initiated. Yet Leiden's assessment of these trials is that "[t]o date, there is little or no published evidence of the clinical efficacy of gene therapy."(15) Leiden does not see this as a condemnation of the field. Rather he draws three conclusions: that gene therapy is grounded in solid scientific principles, that the negative results so far are a function of the newness of the field, and that recent progress promises optimism for the future. (3) How will this resource be allocated?(16) While the consequences of genetic diseases are severe, the numbers of those affected by a particular genetic disease are relatively small--perhaps between 10,000 and 15,000. Can the cost of research and clinical trials for these diseases be justified? While it is true that much can be transferred to other technologies and strategies, it is even more true that victories will come at a high cost and the other health needs of the nation are increasing. Thus the issues of allocation and priorities need substantive national debate.

Germ line gene therapy, by both preventing disease by inserting correct copies of genes into reproductive cells and enabling this correction to be passed on to succeeding generations, presents both technical and ethical problems. Wivel and Walters identify four technical problems that need to be resolved before any human trials could be initiated: the inserted gene will need to function normally; the insertion of the new gene must not cause impairment of normal gene function; there must be no residual effects from the original genetic defect; and there must be no genetic side-effects from the insertion of the new gene. Common to these problems is the challenge of physical placement of a new gene in the proper location. But it is also important that the new copy not cause a problem with the other genes near the site of insertion. The interaction of genes with their neighboring genes at locations along various strands is not well understood and is a major scientific obstacle to initiating human trials.

Because the genetic correction will be passed on to one's descendants, germ line therapy is surrounded by a major debate. The major arguments in favor are: that only this type of therapy, precisely because it is initiated on the fertilized egg, could prevent major damage at the embryonic stage; that such therapy prevents the children of those with a genetic disease from having to undergo somatic cell therapy or from having to make painful reproductive decisions of their own; that germ line therapy is more cost effective because, unlike somatic therapy which has to be repeated generation after generation, this is done once; that researchers are obligated to identify and develop better treatments to offer to their patients; and finally, that germ line therapy is a way to prevent serious health problems rather than attempting to repair the damage after it occurs.(17) The major negative arguments are: that if there are unforeseen negative side-effects, these will be passed down from generation to generation; that the therapy is not needed, since there are other means to prevent transmitting genetic diseases, such as preimplantation diagnosis or selective abortion following prenatal diagnosis; that germ line therapy will be expensive and available only to a small number of individuals; that perfecting the methods of germ line therapy will require much research on human embryos, which many would argue is inappropriate; and finally that, if the technique should prove to be of limited use in curing disease, the focus might shift to the enhancement of one's genetic profile, which would further reduce the number of people who could utilize the technique.(18)

One other area of philosophical concern here is the status of the inherited human genome. As Maurice de Wachter puts it, "Germ-line gene therapy techniques would violate the rights of subsequent generations to inherit a genetic endowment that has not been intentionally modified."(19) Such a position raises several problems: Is there such a right and what is its basis? Since the human genome continues to be modified through evolution, on what basis is the present form privileged? And how is human dignity harmed if one can intervene to prevent a disease from harming an individual and his or her descendents?

This question also focuses on a particular problem in the debate: What is human nature? An important contribution has been made by W. French Anderson, one of the major scientists involved in human gene transfer, who is also well read in the ethical and philosophical literature. Originally concerned that germ line intervention could irreversibly change human nature, Anderson has recently argued that the Platonic resolution of human nature into body and soul is correct. Therefore, since the essence of our nature resides in our soul, no bodily alteration can harm human nature. Thus Anderson winds up with a Platonic/Cartesian dualism that sees the body as a res extensa with no relation to our human nature or our person. This position is substantively critiqued by James Keenan, S.J., who in a seminal article argues for the subjectivity of the body and who reasons that a separation such as Anderson proposes misunderstands personhood. Keenan also demonstrates the necessity of keeping the body-person at the center of ethical analysis because "recent genetic research substantiates the position that the human body is in its genetic roots profoundly relational and that this position provides substantial guidelines for the genetic manipulation of our progeny."(20) To change the body, therefore, is to change the person. And that is the locus of the next issue, the genetic enhancement of humans.

Will we move beyond therapy to enhance particular human characteristics? A major problem is that no particular single gene has been definitely associated with a particular behavioral characteristic, e.g. intelligence. The enhancement debate is also characterized by an unacknowledged genetic determinism, namely that we can do only as our gene tells us. This assumption--that all behaviors, no matter how complex, are caused by a single gene--neglects the role of the environment, both physical and social, in developing our characteristics.(21)

Nonetheless, such theoretical arguments will not slow the quest for enhancement, the primary evidence of which is the growing market in sperm, eggs, and embryos from vendors who list their own appearance, their educational and social background, as well as that of their parents and grandparents. Prenatal diagnosis offers another way to select preferred genomes, and as long as parents want both better children and strategies to achieve them, enhancement will be with us. Now the primary method of enhancement is social, through various child-rearing and educational strategies; in the future it may be attempted by selecting desired genotypes. But no matter the means, desire for enhancement brings dangers. In a most interesting discussion of enhancement, Glen Magee has identified five sins of enhancement to avoid: calculativeness, overbearingness, shortsightedness, hasty judgment, and pessimism.(22)

Consideration of some dimensions of human gene transfer brings us back to many of the same issues previously encountered in discussions of genetic testing: human dignity, the extent of human control over nature, understanding of human nature, and our relation to our descendants.

FREEDOM-DETERMINISM AND HUMAN DIGNITY

The categories of freedom-determinism and human dignity show up sharply in the cloning debate. Does our genetic profile determine who we are? Will our acts be determined by our genome? Is our genome our fate?

Four types of cloning must be distinguished lest the debate become even more confused. Gene cloning and cellular cloning are two methods of increasing supplies of DNA or various cells to facilitate experiments; they have nothing to do with whole organism cloning. A third form of cloning is called blastomere separation or embryo division; it involves artificially twinning an embryo to produce multiple copies. While this form is utilized in the livestock industry routinely, it has been attempted in humans only in the experiment reported by Hall and Stillman.(23) The fourth type is the one that has occupied center stage since the report of the cloning of Dolly in February 1997.(24) This is somatic cell nuclear transfer, or whole organism cloning, in which an egg has its nucleus removed and replaced with the nucleus of another cell which produces an identical genetic copy of the donor. What is of utmost importance in the Dolly experiment is demonstrating that the genetic material in fully differentiated adult cells can be reactivated to generate a whole new being. Such reactivation was previously thought to be impossible (though some now question this because of the impossibility of proving that the cell used for Dolly was in fact an adult cell, though such claims may be ended with the announcement of the cloning of 50 mice, some of which were clones of clones(25)). Second, such a method of reproduction is asexual and occurs without fertilization, hardly the standard way of mammalian reproduction.

When the Dolly story was first made public (the announcement was delayed until three months after her actual birth in order to allow time for the appropriate patents on the technique to be filed), most focused on the application to humans. What had been the stuff of science fiction now appeared to be one more scientific conquest. Yet even in this case most of the debate was misplaced, unless one were a genetic reductionist or determinist. The most common scenario imagined the replication of an almost infinite series of desired genotypes on the assumption that they would essentially be the same person--all Michael Jordan clones would be superior basketball players and all James Watson clones would be superior scientists. There are two major errors in these scenarios. First, the fact that two individuals share the same genetic identity does not mean they are the same person (any more than traditionally conceived identical twins are the same person). Nor does the fact that they share a genetic identity diminish or violate the dignity of either. Second, these scenarios rest on any number of varieties of genetic reductionism that identifies the self with the genome or argues that one's genome alone sets one's life course and all one's choices. Such positions deny any transcendent dimension to the person, any freedom, and simply ignore the role of environment on personal development, either behaviorally or physically. While arguments will continue over the degree of interaction of all these elements, it is clear that the major error of the human cloning debate was genetic reductionism.

Other arguments focused on the violation to human dignity from the process of cloning: not being conceived in the normal fashion, not having two biological parents, not having one's unique genotype.(26) These arguments are not new; they are identical or similar to those raised earlier in discussions of in vitro fertilization. And they involve inherently the same problems.(27) Precisely how is human dignity compromised by a conception that is artificially achieved? What is the basis of the asserted right to be conceived "naturally," to be conceived biologically through heterosexual intercourse, or to have two heterosexual parents? Even the position that human life begins at fertilization is impossible to hold, because in cloning there is no fertilization and no sperm. And what is one to think of current research in which "nucleic DNA from several species--rats, sheep, pigs, and rhesus monkeys--[is inserted] into cows' eggs whose own nuclei have been removed, and the eggs activated the nucleic DNA to produce a clone of the donor of the DNA."(28) If this research is successful, it will solve the problem of the shortage of human eggs for use in assisted reproduction. Thus cloning continues to force the debate over the moral status of the human embryo, and it will heighten the already complex debate over whether or not early human embryos can be created for the exclusive purpose of research or whether or not already created embryos can be used for that purpose. For if the cloning of humans is to go forward, it must be proceeded by some research on human embryos to evaluate both safety and efficacy.

One can distinguish, however, between the means of assisted reproduction and the context of reproduction. If cloning becomes another form of assisted reproduction, it will become another means in a very competitive and lucrative reproductive market. And here the context of reproduction becomes important for moral analysis. First, assisted reproduction is a multimillion dollar per year market, which means that there is keen competition for clients among clinics. Thus there is a strong incentive immediately to implement any new technology that might give one clinic an edge. Andrews reports the statement of a fertility clinician: "We go from mindside to bedside in two weeks. We make things up and try things on patients. We never get their informed consent, because they just want us to make them pregnant."(29) One can hardly expect responsible research on cloning in such a success-driven context. Second, the assumption is that autonomy reigns in this area as in all others in American culture. This of course begs the question whether individual choice is in fact the only morally relevant value in such discussions. Third, and somewhat related, is the assumption that all reproductive choices are private and, therefore, immune from social evaluation. There are social costs to pregnancy that society must bear: higher insurance premiums for plans that subsidize assisted reproduction, increased use of newborn intensive care units resulting from the increase in multiple pregnancies following in vitro fertilization, increase and exacerbation of class division between those who can and those who cannot afford the technologies. Fourth, the residual effects and influence of genetic determinism in attempts to custom design children. As the possibilities of selection increase, so too will pressure to select the "best" eggs and sperm from the "best" genetic heritage. Such efforts will create a complex childhood as well as a narrowing of the range of experiences to which a child may be exposed. Growing up has always had its difficulties; growing up with specific expectations grounded in a carefully selected genetic profile may be even more difficult. Finally, it is clear beyond all doubt that we are gaining incredible control over reproduction; the means of reproduction are being instrumentalized. Consequently, we need to keep clearly in mind the larger ends to which these means are being used and the context in which they are being implemented. While I would argue that there is nothing inherently immoral with any form of assisted reproduction, there is a danger that we may lose the sense of a child as a gift and come to look upon children as means to an end, an end that is as carefully designed and programmed as possible. Such social determinism closes a child's future and violates a child's dignity. How we use our powers of reproduction will reveal much about us and our priorities.

The new biology and the new genetics are revealing that medical information (particularly the most intimate details about one's genome) is no longer private. This information has profound consequences for one's employment opportunities, insurance possibilities, and social standing. How this new consciousness will be integrated into traditional American concerns on privacy has yet to be thought through. Similarly, we have yet to evaluate the social risks that information such as this and the development of gene therapies offer. Though one can develop analogies and appeal to a variety of models, one will still not know the impact of information or therapy until they are actually tried. And then, of course, the impact cannot be withdrawn. The dynamic in American culture has been to do first and question later, if at all. And this tendency may present one of our biggest problems.

A second major issue is the exponentially rapid rate of scientific and technological development. Since the announcement of Dolly, we have also seen the cloning of 50 mice (some of which were clones of clones), the cloning of eight calves, the production of human stem cells from different types of human embryonic tissue, and the claim of using a human-cow embryonic hybrid as another method of developing human stem cells.(30) One can barely keep up with the reports, much less think through the issues. And this pace will continue. A central concern is that many of these developments are produced in private biotech companies that receive no federal funding. This means that there is no necessity of review by an ethics committee or an institutional review board. While some companies have ethical review committees, they are essentially discretionary. Given that research will continue to be controversial as well as complex, we need a way to engage in before-the-fact, responsible discourse over the directions of such research and applications. The Asilomar Conference called by scientists in the wake of the developing recombitant DNA technology in the late 1970s provides a useful model. Perhaps the time for another such conference has come.

(1) William J. Winslade, "Privacy in Health Care," in Encyclopedia of Bioethics, ed. Warren T. Reich, rev. ed. (New York: Macmillan, 1995) 4. 2064-65.

(2) For a list and copies of proposed legislation on genetic privacy and confidentiality, see the website of The National Human Genome Research Institute, , and Philip R. Reilly, "Genetic Privacy Bills Proliferate," The Gene Letter 1 (May 1997), .

(3) Nancy Kass, "Insurance for the Insurers: The Use of Genetic Tests," Hastings Center Report 22 (November-December 1992) 6-11; Thomas H. Murray, "Genetics and the Moral Mission of Health Insurance," Hastings Center Report 22 (November-December 1992) 12-17.

(4) Thomas H. Murray, "Warning: Screening Workers for Genetic Risk," Hastings Center Report 13 (February 1983) 5-8.

(5) For overviews and more detailed discussions, see Barbara Katz Rothman, The Tentative Pregnancy (New York: Viking, 1986); "Genetic Grammar: `Health,' `Illness,' and the Human Genome Project," a special supplement in Hastings Center Report 22 (July-August 1992) S11-S20; Edward M. Berger, "Morally Relevant Features of Genetic Maladies and Genetic Testing," in Bernard Gert et al., Morality and the New Genetics (Sudbury, Mass.: Jones and Bartlett, 1996); R. Gregg, Pregnancy in a High-Tech Age: Paradoxes of Choice (New York: Paragon House, 1993); Larry Thompson, Correcting the Code: Inventing the Genetic Cure for the Human Body (New York: Simon and Schuster, 1994); Gwynne Basen, Margrit Eicher, and Abby Lippman, ed. Misconceptions: The Social Construction of Choice and the New Reproductive and Genetic Technologies (Quebec City: Voyageur, 1996).

(6) For an early framing of the issues, see President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Screening and Counseling for Genetic Conditions (Washington: U.S. Government Printing Office, 1983).

(7) For a highly critical view of genetic testing, see Ruth Hubbard and Richard C. Lewontin, "Pitfalls of Genetic Testing," New England Journal of Medicine 334 (2 May 1996) 1192-93. But see also Francis S. Collins, "BRCA1-Lots of Mutations, Lots of Dilemmas," New England Journal of Medicine 334 (18 Jan 1996) 186-88 which suggests positive strategies for utilizing genetic information on breast cancer; Jerome Groopman, "Decoding Destiny," The New Yorker 76 (9 February 1998) 42-48; Albert Rosenfeld, "At Risk for Huntington's Disease: Who Should Know What and When?" Hastings Center Report 14 (June 1984) 5-8; A. M. Cordi and J. Brandt, "Psychological Cost and Benefits of Predictive Testing for Huntington's Disease," American Journal of Medical Genetics 55 (1995) 618-25; Dorothy C. Wertz et al., "Genetic Testing for Children and Adolescents: Who Decides?" Journal of the American Medical Association 272 (1994) 875-81; Sandi Wiggins et al., "The Psychological Consequences of Predictive Testing for Huntington's Disease," New England Journal of Medicine 327 (12 November 1992) 1401-05. Abstracts and some articles in New England Journal of Medicine are available at their website, . For an excellent British perspective, see The Troubled Helix: Social and Psychological Implications of the New Human Genetics, Theresa Marteau and Martin Richards, ed. (New York: Cambridge University, 1996).

(8) For example, a 30-year-old woman may gain 2.9 to 5.3 years of life expectancy from prophylactic mastectomy, and 0.3 to 1.7 years from prophylactic oophorectomy; see Deborah Schrag et al., "Decision Analysis--Effects of Prophylactic Mastectomy and Oophorectomy on Life Expectancy among Women with BRCA1 and BRCA2 Mutations," New England Journal of Medicine 336 (15 May 1997) 1465-71, and the accompanying editorial in the same issue by Bernardine Healy, "BRCA Genes--Bookmaking, Fortunetelling, and Medical Care" (ibid. 1464).

(9) Dorothy Wertz et al., "Genetic Testing for Children and Adolescents" 875-81. Other areas of application are testing children prior to adoption or deciding how to invest one's resources in one's children. Nancy Wexler, President of the Hereditary Disease Foundation and one of the team that discovered the gene for Huntington's disease, reports that a woman asked to have her two children tested for Huntington's because "she had only enough money to send one of them to Harvard" (Mary Murray, "Nancy Wexler," New York Times Magazine, 13 February 1994, 31).

(10) The reason for this age cut-off is that this is when the risks of having a child with Down syndrome balance the risks of miscarriage from amniocentesis.

(11) Confer the website Options, , for a sample of the genetic pedigrees that can be ordered from egg and sperm vendors.

(12) The single best book on gene therapy is LeRoy Walters and Julie Gage Palmer, The Ethics of Human Gene Therapy (New York: Oxford University, 1997). For the reflections and analysis of one of the main proponents and researchers in the field of gene therapy, see W. French Anderson: "Human Gene Therapy: Why Draw A Line?" Journal of Medicine and Philosophy. (December 1989) 681-93; "Genetics and Human Malleability," Hastings Center Report 20 (1990) 21-24; and "Genetic Engineering and Our Humanness," Human Gene Therapy 5 (1994) 755-59. For general overviews, see the following: Clifford Grobstein and Michael Flower, "Gene Therapy: Proceed with Caution," Hastings Center Report 14 (April 1984) 13-17; Burke K. Zimmerman, "Human Germ-Line Therapy: The Case for its Developments and Use," Journal of Medicine and Philosophy 16 (1991) 593-612; Maurice A.M. de Wachter, "Ethical Aspects of Human Germ-Line Therapy," Bioethics 7 (1993) 166-77; LeRoy Walters, "Human Gene Therapy: Ethics and Public Policy," Human Gene Therapy 2 (Summer 1991) 116-20; David A. Kessler et al., "Regulation of Somatic Cell Therapy and Gene Therapy by the Food and Drug Administration," New England Journal of Medicine 329 (14 October 1993) 1169-73; Nelson A. Wivel and LeRoy Walters, "Germ-Line Gene Modification and Disease Prevention: Some Medical and Ethical Perspectives," Science 262 (22 October 1993) 533-38; Jeff Lyon and Peter Gorner, Altered Fates: Gene Therapy and the Retooling of Human Life (New York: W. W. Norton, 1995).

(13) W. French Anderson and T. Friedmann, "Strategies for Gene Therapy," in The Encyclopedia of Bioethics 2.908.

(14) Walters and Palmer, The Ethics of Human Gene Therapy 36-44.

(15) Jeffrey M. Leiden, "Gene Therapy--Promise, Pitfalls, and Prognosis," New England Journal of Medicine 333 (28 September 1995) 871-73.

(16) I recall being at a meeting where one of the researchers for the first use of gene therapy was discussing the project. When asked the cost of the research, he replied that he had no idea because the National Institutes of Health (NIH) did not submit a bill. But obviously the NIH has a budget, one that has to be set in relation to other budgets in the health field, to say nothing of other national priorities.

(17) Walters and Palmer, The Ethics of Human Gene Therapy 81-82. See also an earlier, but similar phrasing of the arguments in Eric Juengst, "Germ-Line Therapy: Back to the Basics," Journal of Medicine and Philosophy 16 (1991) 587-92. For selected European perspectives on the pros and cons of this debate, see Maurice A. M. de Wachter, "Ethical Aspects of Germ-Line Therapy," Bioethics 7 (1993) 166-77.

(18) Walters and Palmer, The Ethics of Human Gene Therapy 82-83.

(19) de Wachter, "Ethics of Human Germ-Line Therapy" 175.

(20) James Keenan, S.J., "Genetic Research and the Elusive Body," in Lisa S. Cahill and Margaret A. Farley, ed., Embodiment, Morality, and Medicine (Dordrecht, The Netherlands: Kluwer Academic, 1995) 59-73, at 59.

(21) At a meeting attended primarily by scientists to discuss germ line therapy and possible guidelines for its implementation, James Watson suggested that a serious candidate for a disease to be cured by germ line therapy was stupidity (Gina Kolata, "Scientists Brace for Changes in Path of Human Evolution," New York Times, 21 March 1998, A1 and A7).

(22) Glen McGee, The Perfect Baby: A Pragmatic Approach to Genetics (Lanham, Md.: Rowman and Littlefield, 1995) 123-33.

(23) Jerome L. Hall et al., "Experimental Cloning of Human Polyploid Embryos Using an Artificial Zona Pellucida," a paper presented at the 1993 annual meeting of the American Fertility Society. For an overview of this experiment and its subsequent discussion, see the Kennedy Institute of Ethics Journal 4 (September 1994) which devoted the entire issue to this topic. Also Andrea L. Bonnicksen, "Ethical and Policy Issues in Human Embryo Twinning," Cambridge Quarterly of Healthcare Ethics 4 (1995) 268-84.

(24) For early discussions see, James D. Watson, "Moving Toward Clonal Man: Is This What We Want?" The Atlantic, May 1971, 50-53; Martin Ebon, ed. The Cloning of Man: A Brave New Hope--or Horror? (New York: New American Library, 1978); Margaret Brumby and Pascal Kasimba, "When Is Cloning Lawful?" Journal of In Vitro Fertilization and Embryo Transfer 4 (August 1987) 198-204; Ira H. Carmen, Cloning and the Constitution: An Inquiry into Governmental Policymaking and Genetic Experimentation (Madison: University of Wisconsin, 1985). The most comprehensive discussion of cloning can be found in the National Bioethics Advisory Commission, Cloning Human Beings: Report and Recommendation of the National Bioethics Advisory Commission (Rockville, Md.: NBAC, 1997); see also the commentary on this report "Cloning Human Beings: Responding to the National Bioethics Advisory Commission's Report," in Hastings Center Report 27 (September-October 1997) 6-22; Gina Kolata, Clone: The Road to Dolly and the Path Ahead (New York: William Morrow, 1998); Gregory E. Pence, Who's Afraid of Human Cloning? (Lanham, Md.: Rowman and Littlefield, 1998). The entire issue of Cambridge Quarterly of Healthcare Ethics 7 (1998) is devoted to cloning.

(25) Vittorio Sgaramella and Norton D. Zinder, "Letter to the Editor," Science 279 (30 January 1998) 636-66, together with Wilmut's response; see also Gina Kolata, "In Big Advance in Cloning, Biologists Create 50 Mice," New York Times, 22 July 1998, A1 and A20.

(26) See Congregation for the Doctrine of Faith "Donum vitae, Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation" (22 February, 1987); this document along with a commentary can be found in Thomas A. Shannon and Lisa S. Cahill, Religion and Reproduction (New York: Crossroad, 1988). Such positions are not unique to Roman Catholicism; Paul Ramsey, e.g., argues that any reproductive technology that separates reproduction from heterosexual intercourse is immoral (Fabricated Man: The Ethics of Genetic Control [New Haven: Yale University, 1970]).

(27) See Edward Vacek, S.J., "Vatican Instruction on Reproductive Technology," Theological Studies 49 (1988) 110-31.

(28) Lori B. Andrews, "Human Cloning: Assessing the Ethical and Legal Questions," Chronicle of Higher Education, 13 February 1998, B4-B5.

(29) Ibid. B4.

(30) Thomas A. Shannon, "Remaking Ourselves? The Ethics of Stem-Cell Research," Commonweal 125 (December 4, 1998) 9-10.

THOMAS A. SHANNON is professor of religion and social ethics in the department of humanities and arts at Worcester Polytechnic Institute, Worcester, Mass. He obtained his Ph.D. from Boston University. Besides numerous articles, including several in Theological Studies, he is author of An Introduction to Bioethics (Paulist, 1997) and has a book on genetic engineering at a publisher.

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