Should a growing market for genetic self-tests be welcomed or feared? From the point of view of personal autonomy the increasing availability of predictive health information seems promising. Yet it is frequently pointed out that genetic information about future health may cause anxiety, distress and even loss of life-hopes. In this article the argument that genetic self-tests undermine personal autonomy is assessed and criticized. I contend that opportunities for autonomous choice are not reduced by genetic information but by misperceptions and (...) misunderstandings of the results of genetic tests. Since the interpretation of genetic information is sometimes distorted by the information provided about the genetic products, more attention should be given to deceitful marketing that overblows the utility of genetic products. Yet personal autonomy is reduced neither by genetic tests nor by genetic information and there is consequently no compelling case for the conclusion that genetic self-tests should be prohibited. (shrink)

As knowledge increases about the human genome,prenatal genetic testing will become cheaper,safer and more comprehensive. It is likelythat there will be a great deal of support formaking prenatal testing for a wide range ofgenetic disorders a routine part of antenatalcare. Such routine testing is necessarilycoercive in nature and does not involve thesame standard of consent as is required inother health care settings. This paper askswhether this level of coercion is ethicallyjustifiable in this case, or whether pregnantwomen have a right to (...) remain in ignorance ofthe genetic make-up of the fetus they arecarrying. While information gained by genetictesting may be useful for pregnant women whenmaking decisions about their pregnancy, it doesnot prevent harm to future children. It isargued that as this kind of testing providesinformation in the interests of the pregnantwomen and not in the interests of any futurechild, the same standards of consent that arenormally required for genetic testing should berequired in this instance. (shrink)

Genetic testing is currently subject to little oversight, despite the significant ethical issues involved. Repeated recommendations for increased regulation of the genetic testing market have led to little progress in the policy arena. A 2005 Internet search identified 13 websites offering health-related genetic testing for direct purchase by the consumer. Further examination of these sites showed that overall, biotech companies are not providing enough information for consumers to make well-informed decisions; they are not consistently offering genetic counseling services; and some (...) sites even offer tests with little evidence of clinical value. This article aims to raise company and consumer awareness about the ethical concerns surrounding the direct-to-consumer marketing of health-related genetic tests. It also suggests ways that biotech companies can bring their services to the public in an ethically responsible manner, without increased regulatory oversight. (shrink)

Non-therapeutic genetic testing in childhood presents a “myriad of ethical questions”; questions which are discussed and resolved in professional policy and position statements. In this paper we consider an underdiscussed but strongly influential feature of policy-making, the role of selective case and exemplar in the production of general recommendations. Our analysis, in the tradition of rhetoric and argumentation, examines the predominate use of three particular disease exemplar (Huntington’s disease, Tay-Sachs disease and sickle cell disease) to argue for or against particular (...) genetic tests (predictive testing and testing for carrier status). We discuss the influence these choices have on the type and strength of subsequent recommendations. We argue that there are lessons to be drawn about how genetic diseases are conceptualised and we caution against the geneticisation of medical policy making. (shrink)

The debate over the genetic testing of minors has developed into a major bioethical topic. Although several controversial questions remain unanswered, a degree of consensus has been reached regarding the policies on genetic testing of minors. Recently, several commentators have suggested that these policies are overly restrictive, too narrow in focus, and even in conflict with the limited empirical evidence that exists on this issue. We respond to these arguments in this paper, by first offering a clarification of three key (...) concepts—autonomy of the minor, future autonomy, and parental authority—which must be disentangled. We then respond to the arguments by noting the uncertainty of the value of predictive genetic information, and by assessing the psychosocial risks still involved in genetic testing of minors, which are also largely unknown. We conclude that the current consensus position is justified at this stage, in light of the predictions of harm resulting from genetic testing of minors that have not been adequately proved to be unwarranted. (shrink)

For now, the best way to select a child's genes is to select a potential child who has those genes, using genetic testing and either selective abortion, sperm and egg donors, or selecting embryos for implantation. Some people even wish to select against genes that are only mildly undesirable, or to select for superior genes. I call this selection drift– the standard for acceptable children is creeping upwards. The President's Council on Bioethics and others have raised the parental love (...) objection: Just as we should love existing children unconditionally, so we should unconditionally accept whatever child we get in the natural course of things. If we set conditions on which child we get, we are setting conditions on our love for whatever child we get. Although this objection was prompted by selection drift, it also seems to cover selecting against genes for severe impairments. I argue that selection drift is not inconsistent with the ideal of unconditional parental love and, moreover, that the latter actually implies that we should practise selection drift – in other words, we should try to select potential children with the best genetic endowments. My endowment argument for the second claim works from an analogy between arranging an endowment prior to conception to fund a future child's education, and arranging a genetic endowment by selecting a potential child who already has it, where in both cases the child would not have existed without the endowment. I conclude with some programmatic remarks about the nonidentity problem. (shrink)

Scientists, the medical profession, philosophers, social scientists, policy makers, and the public at large have been quick to embrace the accomplishments of genetic science. The enthusiasm for the new biotechnologies is not unrelated to their worthy goal. The belief that the new genetic technologies will help to decrease human suffering by improving the public’s health has been a significant influence in the acceptance of technologies such as genetic testing and screening. But accepting this end should not blind us to the (...) need for an evaluation of whether a particular means is adequate to achieve it. Lack of such evaluation notwithstanding, discussions of the ethical, legal, and social implications have tended to presuppose that the development and implementation of genetic testing will be an appropriate means to reduce human suffering in significant ways. I argue here that such an assumption is mistaken. In part this is the case because human biology is more complex than sometimes it is made to appear in these debates. But, the idea that human suffering resulting from disease can be reduced in significant ways with the use of genetic testing also ignores the social contexts in which these technologies are being developed and implemented. (shrink)

The physician-patient relationship has changed over the last several decades, requiring a systematic reevaluation of the competing demands of patients, physicians, and families. In the era of genetic testing, using a model of patient care known as the family covenant may prove effective in accounting for these demands. The family covenant articulates the roles of the physician, patient, and the family prior to genetic testing, as the participants consensually define them. The initial agreement defines the boundaries of autonomy and benefit (...) for all participating family members. The physician may then serve as a facilitator in the relationship, working with all parties in resolving potential conflicts regarding genetic information. The family covenant promotes a fuller discussion of the competing ethical claims that may come to bear after genetic test results are received. (shrink)

Gaucher disease is a rare, chronic,ethnic-specific genetic disorder affecting Jewsof Eastern European descent. It is extremelyexpensive to treat and presents difficultdilemmas for officials and patients in Israelwhere many patients live. First, high-cost,high-benefit, but low volume treatment forGaucher creates severe allocation dilemmas forpolicy makers. Allocation policies driven bycost effectiveness, age, opportunity or needmake it difficult to justify funding. Processoriented decision making based on terms of faircooperation or decisions invoking the ``rule ofrescue'''' risk discriminating against minoritieswho may already suffer from inequitabledistribution of (...) heath care resources. Apartfrom cost, Gaucher disease prompts questionsabout abortion. Unlike severe geneticdisorders, Gaucher offers no grounds forabortion and, in many ways, is analogous togender based abortions that are prohibitedregardless of fetal age. Finally, Gaucherraises concerns about the disclosure of geneticinformation. These affect potential carriersasked to participate in population studies andcarriers and patients who must considerdisclosure to others. These concerns weigh theright to privacy against communal interests andbilateral commitments. (shrink)

Epidemiologists and geneticists claim that genetics has an increasing role to play in public health policies and programs in the future. Within this perspective, genetic testing and screening are instrumental in avoiding the birth of children with serious, costly or untreatable disorders. This paper discusses genetic testing and screening within the framework of eugenics in the health care context of India. Observations are based on literature review and empirical research using qualitative methods. I distinguish ‘private’ from ‘public’ eugenics. I refer (...) to the practice of prenatal diagnosis as an aspect of private eugenics, when the initiative to test comes from the pregnant woman herself. Public eugenics involves testing initiated by the state or medical profession through (more or less) obligatory testing programmes. To illustrate these concepts I discuss the management of thalassaemia, which I see as an example of private eugenics that is moving into the sphere of public eugenics. I then discuss the recently launched newborn screening programme as an example of public eugenics. I use Foucault’s concepts of power and governmentality to explore the thin line separating individual choice and overt or covert coercion, and between private and public eugenics. We can expect that the use of genetic testing technology will have serious and far-reaching implications for cultural perceptions regarding health and disease and women’s experience of pregnancy, besides creating new ethical dilemmas and new professional and parental responsibilities. Therefore, culturally sensitive health literacy programmes to empower the public and sensitise professionals need attention. (shrink)

(No abstract is available for this citation).

Much of the current genetic research into aggressive and violent behaviour focuses on young people and might appear to offer the hope of targeted prediction and intervention. In the UK data is collected on children from various agencies and collated to produce ‘at risk of offending’ identities used to justify intervention. Information from behavioural genetic tests could conceivably be included. Regulatory frameworks for collecting, storing and using information from DNA samples differ between the health service and the police particularly in (...) the need for consent and the treatment of children. This paper draws on discussions with professionals involved with ‘problem’ young people to consider their views on the utility of genetic research for tackling violent/aggressive behaviour and the impact an identification of genetic susceptibility might have on their clients. (shrink)

In recent years, science and the courts have created new options whereby prospective parents can avoid the birth of a diseased or defective child. We can ascertain the likelihood that certain genetic diseases will be transmitted; We can detect a number of fetal abnormalities in utero ; we have legal permission to abort for any reason, including fetal abnormality. With these new options come new questions concerning our moral obligations toward our prospective offspring. An important conceptual question concerns whether such (...) congenital diseases and defects constitute harms to the children who bear them. In this essay I shall examine the prevailing analysis of harm, the "Otherwise-Condition" approach, which denies that we can predicate harm of such abnormalities. I will show first that this analysis is inadequate even to account for certain very ordinary, clear cases of harm. It thus is suspect regardless of its stance on congenital anomalies. Second, it sets up an ill-considered connection between harm and causation – a connection which renders its harm ascriptions slippery, arbitrary. Finally, this analysis cannot be squared with certain of our deeply entrenched moral intuitions. By thus rebutting this most influential definition of harm, I will have opened the door to the possibility of ascribing harm for congenital disease and defect. Keywords: Harm, Otherwise-condition, Congenital anomaly * I would like to thank A. D. Woozley, Derek Parfit, Daniel Devereux, and the editors and reviewers of the JMP for their helpful comments on earlier drafts of this paper. CiteULike Connotea Del.icio.us What's this? (shrink)

The practice of prenatal diagnosis has brought with it the utilization of pregnancy termination as a preventive approach. In this paper the genetic/teratologic, fetal and maternal indications for termination of pregnancy used in Hungary are described, as well as the legal requirements and the proposed mode of termination at the different stages of gestation. The author is the director of the largest prenatal genetic counseling service in Hungary. Keywords: elective abortion, medico-legal aspects, prenatal diagnosis, genetic disorders, Hungary, bioethics CiteULike Connotea (...) Del.icio.us What's this? (shrink)

: There is a general consensus in the medical and medical ethics communities against predictive genetic testing of children for late onset conditions, but minimal consideration is given to predictive testing of asymptomatic children for disorders that present later in childhood when presymptomatic treatment cannot influence the course of the disease. In this paper, I examine the question of whether it is ethical to perform predictive testing and screening of newborns and young children for conditions that present later in childhood. (...) I consider the risks and benefits of (1) predictive testing of children from high-risk families; (2) predictive population screening for conditions that are untreatable; and (3) predictive population screening for conditions in which the efficacy of presymptomatic treatment is equivocal. I conclude in favor of parental discretion for predictive genetic testing, but against state-sponsored predictive screening for conditions that do not fulfill public health screening criteria. (shrink)

New dimensions in different ethical scenarios following genetic information require new medical-ethical Action Guides for physician-patient interaction. This paper discusses the ambiguity in moral choice between a "right not to know" and "a duty to know", regarding parental decisionmaking pro or contra selective abortion following prenatal screening for autosomal dominant polycystic kidney disease (Potter III) and related public policy issues. Keywords: abortion, autosomal dominant polycystic kidney disease, differential ethics, duty to know, genome diagnosis, predictive medicine, right not to know, scenario (...) assessment CiteULike Connotea Del.icio.us What's this? (shrink)

In Sri Lanka, termination of pregnancy, other than in extreme circumstances, is strictly illegal. Among the public and large sections of the medical community there is widespread support for some degree of liberalization of the law, particularly where this relates to serious genetic conditions which can be identified prenatally. Tension emerges out of a publicly maintained conservatism on issues of abortion on the one hand and a growing disconnection from unregulated practices of termination in the private sector on the other. (...) Social science approaches have much to contribute when understanding the ‘therapeutic gap’ that opens up and, in particular, the way that local ideas of fate, destiny and how suffering might be ameliorated become blended with the predictive power of genetic testing. (shrink)

In this essay, I indicate how social-science approaches can throw light on predictive genetic testing (PGT) in various societal contexts. In the first section, I discuss definitions of various forms of PGT, and point out their inherent ambiguity and inappropriateness when taken out of an ideal–typical context. In section two, I argue further that an ethics approach proceeding from the point of view of the abstract individual in a given society should be supplemented by an approach that regards bioethics as (...) inherently ambiguous, contested, changeable and context-dependent. In the last section, I place these bioethical discussions of PGT in the context of Asian communities. Here, a critical view of what constitutes a community and culture proves necessary to understand the role of bioethical debates and the empirical manifestations of PGT in Asian societies. A discussion of the concepts of family and kinship in relation to PGT indicates that any bioethical analysis has to take into account that bioethical values are not just reflections of a cultural community, but embody both bioethical ideals and prevalent political rhetoric which is exhibited, propagated and manipulated by individuals and collectives for a variety of purposes. I end by summarising the contributions that social science could make to the understanding of the bioethics of PGT. (shrink)

Modern medicine emphasizes treatment of the sick. It is often said that the widespread genetic testing soon to follow the completion of the Human Genome Project will usher in a new era of preventive medicine. Such changes require new ways of thinking, however. For example, there may be nothing clinically wrong with a healthy patient who requests genetic testing, even if the tests reveal disease genes. Since all individuals have genetic skeletons in their closets, it is important to be careful (...) not to confuse having disease genes with having the diseases that they cause. Unfortunately, many in the public have adopted a kind of genetic determinism that sees genes as destiny: for example, having the gene associated with colon cancer means they will develop colon cancer. Physicians tend to be more careful, yet even they are not immune to subtle versions of genetic determinism. One example of this is the uncritical categorization of certain diseases as “genetic”. In fact, an adequate concept of genetic disease is extremely difficult to come by. The simplest notion would require a 1:1 correspondence between a disease and its genes, but this is the exception rather than the rule. For example, cystic fibrosis (CF) is often put forward as a good example of a genetic disease, since it seems to result from mutations in a single gene, CFTR. Even in this case, however, the exact relationship between CFTR mutations and disease is not clear, as virtually every possible combination of sweat chloride test results, genetic test results, and symptoms has been observed.[1] If a patient presents with the classic symptoms of CF and is found to have a mutation in the CFTR gene, the physician might understandably infer that the mutation caused the disease. But if an asymptomatic patient is tested and it is discovered that he or she has a CFTR mutation, it is unclear what this means. The doctor might tell the patient the gene is abnormal and that he or she is likely to develop pulmonary problems, etc., but it’s not really known whether even this qualified prognosis is true.. (shrink)

This paper provides an empirical account of commercial genetic predisposition testing in mainland China, based on interviews with company mangers, regulators and clients, and literature research during fieldwork in mainland China from July to September 2006. This research demonstrates that the commercialization of genetic testing and the lack of adequate regulation have created an environment in which dubious advertising practices and misleading and unprofessional medical advice are commonplace. The consequences of these ethically problematic activities for the users of predictive tests (...) are, as yet, unknown. The paper concludes with a bioethical and social science perspective on the social and ethical issues raised by the dissemination and utilization of genetic testing in mainland China. (shrink)

Health policy is increasingly confronted with the demand for financing genetic testing on inherited susceptibility to disease. Tests on polymorphism/SNP associated with multicausal and chronic conditions are already offered in private commercial institutions or in academic hospitals. The increasing pressure on public health services to offer SNP testing leads to first methodological approaches for a generally valid regulatory framework applicable for inclusion or refusal of genetic tests into the public health services. Systematic search in Medline, Embase and the Web for (...) methodological papers or guidelines for the assessment of polymorphism-screening. Since genetic testing has not only clinical and economic effects on health care, but also primarily ethical consequences by profiling our understanding of health and disease , this paper gives an overview of relevant aspects and background information to consider in the assessment of genetic tests. Although 2–3 million SNPs are identified and the journals are full of reported significant associations between disease and mutation, only a few can be replicated unequivocally. The ACCE (Analytic and Clinical Validity, Clinical utility; Ethical, legal and social implications)-framework was developed by the Center of Disease Control for the assessment of genetic testing. This standardised appraisal approach proposes collecting and evaluating: (a) Prevalence, genotype-/phenotype-relation. (b) Clinical presentation: natural history; the different expressions of disease. (c) Performance of the genetic test. (d) Implications for therapy and prevention. (e) Conclusion for clinical applications of risk-profiling of health on their susceptibility to disease and/or for clarification of disease for therapy planning. Since genetic testing is urging its way into the health care system, the actual danger is, that population screening starts before valid evidence from big prospective studies have been carried out and delivered proofs of direct causal associations. Before diffusing into the health care system we are suggesting to take a cautious and standardised approach. (shrink)

: Decisions about funding health services are crucial to controlling costs in health care insurance plans, yet they encounter serious challenges from intellectual property protection—e.g., patents—of health care services. Using Myriad Genetics' commercial genetic susceptibility test for hereditary breast cancer (BRCA testing) in the context of the Canadian health insurance system as a case study, this paper applies concepts from social contract theory to help develop more just and rational approaches to health care decision making. Specifically, Daniels's and Sabin's "accountability (...) for reasonableness" is compared to broader notions of public consultation, demonstrating that expert assessments in specific decisions must be transparent and accountable and supplemented by public consultation. (shrink)

Public discussions of ethical issues related to the biotechnology industry tend to treat “biotechnology” as a single, undifferentiated technology. Similarly, the pros and cons associated with this entire sector tend to get lumped together, such that individuals and groups often situate themselves as either “pro-” or “anti-” biotechnology as a whole. But different biotechnologies and their particular application context pose very different challenges for ethical corporate decision-making. Even within a single product category, different specialty products can pose strikingly different ethical (...) challenges. In this paper, we focus on the single over-arching category of “genetic testing” and compare tests for disease susceptibility and drug response. We highlight the diversity of ethical challenges – grouped under the broad categories of “truth in advertising” and “protecting intellectual property” – raised by the commercialization and marketing of these technologies. By examining social and technical differences between genetic tests, and the associated corporate ethics challenges posed by their commercialization, our intent is to contribute to the nascent business ethics literature examining issues raised by the development and marketing of genetic tests. (shrink)