Biomedical subjects
Publications and source records attributed to E T Juengst.
The author praises Sharp and Foster's differentiation of the forms of "community review," and agrees that the discussion is far from settled. He argues that rather than attempting to define "community" by various criteria, it might be more helpful to both researchers and research subjects to enable persons to create their own communities: a process of community construction, rather than reaction.
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OBJECTIVE: Primary caregivers should be aware of recent progress in the genetics of Alzheimer disease (AD) and of the clinical and ethical considerations raised regarding the introduction of genetic testing for purposes of disease prediction and susceptibility (risk) analysis in asymptomatic individuals and diagnosis in patients who present clinically with dementia. This statement addresses arguments for and against clinical genetic testing. PARTICIPANTS: The 20 participants were selected by the investigators (S.G.P., T.H.M., A.B.Z., and P.J.W.) to achieve balance in the areas of genetics, counseling, ethics, and public policy, and to include leadership from related consensus projects. The consensus group met twice in closed meetings and carried on extensive correspondence over 2 years (1995-1997). The project was supported by the National Human Genome Research Institute of the National Institutes of Health. EVIDENCE: All 4 involved chromosomes were discussed in group meetings against a background of information from several focus group sessions with AD-affected families. The focus groups comprised volunteers identified by the Cleveland Area Chapter of the Alzheimer's Disease and Related Disorders Association and represented a variety of ethnic populations. CONSENSUS PROCESS: The first draft was written in April 1996 by the principal investigator (S.G.P.) after the consensus group had met twice. The draft was mailed to all consensus group members 3 times over 6 months for extensive response and redrafting by the principal investigator until all members were satisfied. CONCLUSIONS: Except for autosomal dominant early-onset families, genetic testing in asymptomatic individuals is unwarranted. Use of APOE genetic testing as a diagnostic adjunct in patients already presenting with dementia may prove useful but it remains under investigation. The premature introduction of genetic testing and possible adverse consequences are to be avoided.
In discussions of the ethics of human gene therapy, it has become standard to draw a distinction between the use of human gene transfer techniques to treat health problems and their use to enhance or improve normal human traits. Some dispute the normative force of this distinction by arguing that it is undercut by the legitimate medical use of human gene transfer techniques to prevent disease-such as genetic engineering to bolster immune function, improve the efficiency of DNA repair, or add cellular receptors to capture and process cholesterol. If disease prevention is a proper goal of medicine, these critics argue, and the use of gene transfer techniques to enhance human health maintenance capacities will help achieve that goal, then the "treatment/enhancement" distinction cannot define the limits of legitimate gene therapy. In this paper, I argue that a line can be drawn between prevention and enhancement for gene therapy (and thus between properly medical and nonmedical uses of gene therapy), but only if one is willing to accept two rather old-fashioned claims: 1) Some health problems are best understood as if they were entities in their own right, reifiable as processes or parts in a biological system, with at least as much ontological objectivity and theoretical significance as the functions that they inhibit. 2) Legitimate preventive genetic health care should be limited to efforts to defend people from attack by these more robust pathological entities, rather than changing their bodies to evade social injustices.
Authors participating in the renewed discussion of germ-line gene therapy have begun conflating two senses of the term "prevention," which I distinguish as "phenotypic prevention" and "genotypic prevention." Phenotypic prevention describes medical efforts to forestall the clinical manifestation of a genetic disease in an at-risk patient, like newborn screening and dietary prophylaxis for phenylketonuria. Genotypic prevention, by contrast, describes efforts to avoid the transmission of particular genotypes to the next generation, like selective termination following intrauterine diagnosis. Genotypic prevention is either performed on behalf of a prospective parent (or two) as a reproductive risk reduction strategy, or as a public health intervention to reduce the incidence of a disease in the larger population. Conflating phenotypic and genotypic prevention in discussions of germ-line gene therapy is dangerous, because it blurs the line (well-established in clinical genetics) between medical interventions appropriate to prescribe to individuals and families, and reproductive choices that should be theirs alone to make. As the new genetic medicine emerges, its pioneers should be careful to articulate their professional goals in ways that respect that important moral boundary, by explicitly excluding genotypic prevention from among them.
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This essay reviews the efforts of the U.S. Human Genome Project to anticipate and address the ethical, legal, and social implications of new advances in human genetics. Since 1990, approximately $10 million has been awarded by the National Institutes of Health and the Department of Energy, in support of 65 research, education, and public discussion projects. These projects address four major areas of need: (1) the need for both client-centered assessments of new genetic services and for improved knowledge of the psychosocial and ethnocultural factors that shape clients' clinical genetic experiences; (2) the need for clear professional policies regarding human-subject research, clinical practice standards, and public health goals in human genetics; (3) the need for social policy protection against unfair access to and use of personal genetic information; and (4) the need for improved public and professional understanding and discussion of these issues. The Human Genome Project's goal is to have defined, by 1995, policy options and programs capable of addressing these needs.
The articles in this issue illuminate psychosocial issues raised by the development and delivery of new medical technologies. Five kinds of questions surface repeatedly: questions about a technology's purpose(s), the value judgments it presumes, the locus of its control, the external forces that drive it, and its long-term social risks. These questions take the discussion of new technologies beyond the challenge of improving access to their benefits. They also raise issues that will become increasingly important as the capabilities of medical technology expand. For example, they suggest research questions for three other emerging medical technologies: use of biosynthetic growth hormone to treat short stature in hormonally normal children, genetic tests on fetal cells from the circulating maternal blood, and development of clinically reliable biomarkers of the aging process. Part Three of this issue provides a theoretical basis for encouraging psychosocial perspectives in this area, by illustrating the central role that "robust," multifaceted analysis has come to play within the methods of bioethics.
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In this essay, I examine the sources and reach of the NIH "Points to Consider." These guidelines are based on normative considerations inherited from two sets of science policy deliberations that took place in the United States during the 1970s: the discussion of research with human subjects and the recombinant DNA debate. The combined lessons of those deliberations provide six criteria by which to evaluate human gene therapy proposals. While these criteria could be used to reject proposals to attempt germ-line gene therapy or enhancement engineering today, they provide no principled basis for publicly proscribing the development of these forms of genetic intervention. Instead, they will ultimately lead us to approach the moral limits of gene therapy as a professional policy question about the goals of medicine, rather than as a social policy question about the public good.
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Although the ability to perform gene therapy in human germ-line cells is still hypothetical, the rate of progress in molecular and cell biology suggests that it will only be a matter of time before reliable clinical techniques will be within reach. Three sets of arguments are commonly advanced against developing those techniques, respectively pointing to the clinical risks, social dangers and better alternatives. In this paper we analyze those arguments from the perspective of the client-centered ethos that traditionally governs practice in medical genetics. This perspective clarifies the merits of these arguments for geneticists, and suggests useful new directions for the professional discussion of germ-line gene therapy. It suggests, for example, that the much discussed prospect of germ-line therapy in human pre-embryos may always be more problematic for medical genetics than adult germ-line interventions, even though the latter faces greater technical difficulties.