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CGREAL Home * Genetics in the News * Genetics in the Literature * Archive
Center News Join us in congratulating CGREAL predoctoral trainee Aaron Goldenberg on the successful defense of his doctoral disseration on November 19, 2009, examining ethical and policy issues in the use of newborn screening bloodspots for genomic research. Hooray, Dr. Goldenberg!
OpportunitiesCall for 8th IAS-STS Conference 2009 on "Critical Issues in Science and Technology Studies" A main focus of the conference will include research projects providing a critical analysis of human genetic research or of agricultural biotechnology. Researchers investigating either ethical, legal and social aspects of genetic testing in the medical domain or risk policy and wider governance issues related to agricultural biotechnology are especially encouraged to contribute.
Practical Biobanking: an intensive course
Summer Institute in Public Health Genetics: Translating Genomics into Policy and Practice June 22-26, 2009 Seattle, Washington
ResourcesCenters for Excellence in ELSI Research (CEER) Bibliographic database of audiovisuals, books, and articles, many of which are indexed using the Bioethics Thesaurus for Genetics.
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"));Genetics in the News
NHLBI Opens Resource for Genetic and Clinical Asthma Data (GenomeWeb News) "The new project is part of the NHLBI's SNP Health Association Resource (SHARe), a web-based dataset that provides researchers with free access to data from multiple, large population-based studies such as the Framingham Heart Study. ..."
NHGRI, UVA Begin Program for Genomics Education for Nurses and Physician Assistants (GenomeWeb News) "The open access materials will be freely available on a website that will be used by both nursing educators and physician assistants to help them develop and review educational information on genetics and genomics. ..."
Amish gene 'limits heart disease' (BBC ) "A gene mutation which protects the heart against a high-fat diet has been found in the Amish population. ..."
U.K. Geneticists Concerned Patent Ruling On Breast Cancer Gene Test Could Stifle Innovation "A recent ruling by the European Patent Office could make it more difficult and costly for health care providers in the United Kingdom to test for the BRCA1 genetic mutation ..."
Vatican document warns certain new research violates moral principles "Somatic-cell gene therapy is in principle morally acceptable. But is it not permissible to make genetic modifications that seek to transmit the effects to the subject's offspring, called germ-line cell therapy, because of potential harm to the progeny, the document said. ..."
Biomorality: The uses and abuses of science in political life "Put another way, the hidden moral premises of science-especially those concerning health-have so insinuated themselves into our collective consciousness that any attempt to challenge them in the name of other goods is almost invariably a defensive, rearguard action. Such attempts can slow but not stem the tide of "progress," and rollbacks are all but unimaginable. ..."
Kaiser 'biobank' may yield big health dividends - Inside Bay Area "They already have 20,000 cheek swabs yielding human DNA, and with a new $8.6 million grant announced Tuesday, Kaiser Permanente researchers plan to collect nearly a half-million more to stock a repository of DNA that rivals the world's largest. ..."
National Physician Group MDVIP Partners with Navigenics to Provide Personal Genetic Tests for Preventive Medicine Practice "Navigenics is pleased to announce a new relationship with a national network of physicians who practice proactive, personalized medicine. Through the collaboration, the Navigenics genetic testing service will be made available to their patients, who number more than 100,000 nationwide. ..."
Feeling lonely? Genes might be at fault - CNN.com "Research suggests that the degree of loneliness that any two people feel in a particular situation may vary widely, partly because of genetics. ..."
Genetic test for spinal muscular atrophy should be offered to all couples, says the ACMG "American College of Medical Genetics makes new recommendations on population carrier screening for SMA ..."
Nanotechnology 'culture war' possible "Rather than infer that nanotechnology is safe, members of the public who learn about this novel science tend to become sharply polarized along cultural lines ..."
Genetic markers identified for alcohol response "The researchers found that a DNA sequence variation, known as a single nucleotide polymorphism (SNP), on chromosome 15 is significantly associated with the level of response to alcohol and could signal the genetic factors that affect alcohol abuse ..."
Patient consent forms should educate not intimidate "Study says doctor-patient communication is key to good health ..."
Alcohol and a polymorphism of the monoamine oxidase A gene predict impulsive violence "The monoamine oxidase A (MAOA) gene is an outer membrane mitochondrial enzyme that breaks down monoamines such as serotonin, noradrenalin and dopamine. A common polymorphism in MAOA results in high- or low-activity MAOA, and both genotypes have been linked to aggression and violence. A Finnish study has found that drinking and high-activity MAOA can predict the risk of impulsive violence, while aging may decrease this risk. ..."
Bioethicist advocates a new form of eugenics "But the whole enterprise is fraught with danger, and the desire to move on to designer babies, complete with improved musical and mathematical abilities -- as Savulescu desires -- is surely putting us on the wrong road. ..."
Genetics in the Literature
"The author reflects on the Genetic Information Nondiscrimination Act (GINA). He claims that the U.S. legislation's implications would be difficult to determine because of various factors, including its scope's limitation to employment and health insurance, the lack for regulations for its implementation and the need to challenge the legislation in order to highlight is ability to protect genetic information. He argues that both potential risks and benefits should be discussed about the applications of genetics. ..."
"The commercialization of "big sciencer" is in full swing, leading to situations in which the ethical principles of academia are beginning to be compromised. This is exemplified by the profitable business of genetic ancestry testing. The goals of this sort of lsquobig sciencersquo are not necessarily in any way novel, however. In particular, large genotyping projects have a certain start-up time when their design is frozen in, so that the projects often lag behind the development of genetic knowledge. On the other hand, extremely provisional knowledge about potential disease markers is being rapidly turned into questionable lsquotestsrsquo, purporting to determine risk factors for complex disorders, by private companies that are eager to get their share of a profitable market of the future. The flow of money generated by such concerns looks likely to erode traditional research operations and small-scale projects, which risk becoming pebbles on the "big science" landscape.. ..."
"This paper details how patent law purifies inventing subject of big science while simultaneously disqualifying others from patent eligibility for practicing a similar form of collective authorship. The author begins by detailing what is known as the romantic author trope - the assumption within (Western) patent law that invention is the product of one (versus many). The romantic author trope, however, runs counter to the (collective) inventive process in developing countries. Yet this raises the question: are not the inventions of global capital collective in nature? To understand how the collective nature of invention becomes masked by patent law I introduce the idea of corporate authorship. The paper concludes by making visible the inventive assemblages that make the patentable artifacts of big science possible. ..."
" The FTO variant that confers a predisposition to obesity does not appear to be involved in the regulation of energy expenditure but may have a role in the control of food intake and food choice, suggesting a link to a hyperphagic phenotype or a preference for energy-dense foods. ..."
"Investigators at the National Cancer Institute were faced with a decision about whether it would be appropriate to disclose apparently "unwanted" research test results (length of telomeres in leukocyte subsets) to an adolescent about risk of future disease (dyskeratosis congenita), possibly causing psychological harm and an ethical wrong. These issues were not expected at the outset of the family's study participation but rather emerged with new data about the research tests. Disclosure of the research finding was an important consideration in order to avoid using the adolescent as a stem-cell donor for his sister. Disclosure to the adolescent could not be justified by merely considering the immediate interests and preferences of the adolescent. However, an expanded ethical analysis that considers the adolescent's familial context offers a more complete picture of the adolescent's interests and preferences which provides justification for disclosure. . ..."
Elkin, K. (2008). "The new regulation of non-consensual genetic analysis in New Zealand." J Law Med 16(2): 246-62.
"The Human Tissue Act 2008 (NZ) makes it a criminal offence for human tissue to be collected for analysis, or to be analysed, without informed consent. The Ministry of Health has described the provisions of the Act as "clos[ing] a gap in current regulation" of such activities. This article questions whether the Act will have this effect, whether it is likely to achieve the other aims as stated by the government in championing it, and how the Act fits with existing regulation. ..."
Guvercin, C. H. and B. Arda (2008). "Eugenics concept: from Plato to present." Hum Reprod Genet Ethics 14(2): 20-6.
"All prospective studies and purposes to improve cure and create a race that would be exempt of various diseases and disabilities are generally defined as eugenic procedures. They aim to create the "perfect" and "higher" human being by eliminating the "unhealthy" prospective persons. All of the supporting actions taken in order to enable the desired properties are called positive eugenic actions; the elimination of undesired properties are defined as negative eugenics. In addition, if such applications and approaches target the public as a whole, they are defined as macro-eugenics. On the other hand, if they only aim at individuals and/or families, they are called micro-eugenics. However, developments in genetics and its related fields have now enabled eugenic thoughts to reappear under the spotlight and this is creating new moral dilemmas from an ethical perspective. ..."
"The mapping of the human genome and scientific discoveries regarding genetic contributions to disease hold great promise for the prevention and treatment of an array of conditions. Social workers and other professionals must keep abreast of these developments and the ethical dimensions of such progress. Familiar ethical provisions such as confidentiality, informed consent, self-determination, and social justice take on new meaning in light of innovations in genetic science. This article reviews ethical issues and practice implications emerging from advances in genetics knowledge, and it suggests mechanisms for continuing professional development and involvement in this important area. ..."
"For years, sociologists working in other countries or UK-based medical sociologists have complained about the effects of having to seek approval from a research ethics committee (REC) or its equivalent before starting work. With the arrival of the ESRC's Research Ethics Framework, concern about ethics review has expanded to sociologists working on a wider range of topics. This article uses ethnographic data from a study of UK RECs to examine how these bodies assess applications from social scientists, particularly those proposing qualitative research (which opponents claim is given an especially hard time by such committees). These data challenge the idea that RECs are somehow ideologically biased against qualitative research and that they cannot give an adequate assessment of applications from sociologists and other social scientists. The article concludes by suggesting sociologists' time would be better spent studying the institutional nature of the university RECs stimulated by the ESRC. ..."
"Ethical considerations in psychiatric genetics are highly complex and fluid. This review introduces the reader to the wide range of ethical considerations in this field by examining four characteristics of genetic information. First, genetic information may, to a greater or lesser extent, predict a person's future health. Second, learning about one's genotype may have profound psychosocial consequences. Third, genetic information pertains to a person's biological relatives and thus can affect family members, communities, and population groups. Finally, psychiatric genetics is a rapidly evolving field. None of these characteristics is necessarily “exceptional†or unique to genetics, but they provide a useful framework for teasing apart a complex set of ethical considerations. This article reviews conceptual and empirical data that speak to these four characteristics and then presents a set of conceptual frameworks that can be used to systematically analyze the ethics of psychiatric genetic research and clinical genotyping. Finally, directions for future study are described—including the urgent need to gather data on actual risks and benefits of psychiatric genetic research and clinical applications, so that their utility can be assessed and appropriate ethical safeguards identified. ..."
"The inclusion of children in longitudinal research using biobanks raises specific ethical and legal issues. This article analyzes ethical frameworks concerning participation in biobanks and suggests that such frameworks, developed in the context of competent adults as research subjects, are not adapted for research involving children. It concludes that there is a need to elaborate guidelines specific to biobanks and longitudinal studies involving children and provides recommendations regarding parental authorization, the child?s assent and consent, and on the return of results in this context. ..."
Khanfar, N., D. Loudon, et al. (2007). "FDA Direct-to-Consumer Advertising for Prescription Drugs: What Are Consumer Preferences and Response Tendencies?" Health Mark Q 24(1/2): 77-91.
"The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to “reminder,”“help-seeking,” and “product-claim” FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources. ..."
"On 9 May 2005, the Israeli Ministry of Health issued guidelines spelling out the conditions under which sex selection by preimplantation genetic diagnosis (PGD) for social purposes is to be permitted in Israel. This article first reviews the available medical methods for sex selection, the preference for children of a specific gender in various societies and the ethical controversies surrounding PGD for medical and social purposes in different countries. It focuses then on the question of whether procreative liberty or parental responsibility should be the centre of attention in this context. Finally, the article critically examines the new Israeli guidelines and their implications for the women undergoing the necessary medical treatments, for the children born as a result, for other members of the family and for society in general. ..."
"This article, detailing the implications of "ethics drift" for critical work in the academy, reports on an ethics challenge to a non-research-based scholarly text. It analyzes how General Research Ethics Boards (GREBs) can threaten academic freedom when they lack a clear definition of "human subject" research, fail to distinguish between empirical research using humans and scholarly engagement of important social/political issues within human contexts, and overstep the limits of their jurisdiction when they agree to arbitrate on scholarship that ought to be resolved through open debated rather than administrative mechanisms. The article emphasizes that in public democratic institutions, those who contribute to decisions and policies, whether through formal process or by informal tacit ideology, are acting not as individuals but as functionaries of the institution and must bear public accountability and its attendant critiques. The article ends with a recommendation for arms-length oversight of the workings of GREBs. ..."
Mahowald, M. B. (2008). "Babies by (intelligent) design?" Perspect Biol Med 51(4): 629-35.
"Advances in reproductive technology and genetic interventions raise questions about the possibility of using these procedures to promote the birth of children with socially advantageous conditions. In Babies by Design, Ronald M. Green supports this goal and accuses its opponents of a "status quo bias." Unfortunately, some of Green's own arguments also show a status quo bias. Moreover, although he attempts to avoid the thorny issue of the moral status of human embryos, he implicitly takes a stand on it by endorsing prenatal interventions that inevitably entail the creation and loss of some human embryos. This essay identifies these and other flaws in Green's account. ..."
"As individual plaintiffs [of personal injury from medical malpractice or product liability cases] usually cannot afford to finance the litigation, their attorneys must fund the case using their own resources on a contingency fee basis. One implication of this financial relationship is that plaintiffs’ attorneys are generally reluctant to litigate and fund novel claims based on new scientific evidence. However, once a new claim has proven to be successful by one or more favorable verdicts and ‘blood is in the water’, there will be a swarm of lawyers willing to file and finance similar ‘copycat’ suits. For a new field such as pharmacogenomics, this litigation dynamic means that there will likely be an initial calm until there has been a breakthrough case, and then there will be a sudden storm of litigation that will have immediate and enormous implications for defendants, including manufacturers, providers and payors. ..."
Munnich, A. (2008). "Is genetics inhumane?" J Med Genet 45(10): 632-634.
"Objectives and Methods: Many authors have argued that ethical, legal, and social issues () should be explicitly integrated into health technology assessment (HTA), yet doing so poses challenges. This discussion may be particularly salient for technologies viewed as ethically complex, such as genetic screening. Here we provide a brief overview of contemporary discussions of the issues from the HTA literature. We then describe key existing policy evaluation frameworks in the fields of disease screening and public health genomics. Finally, we map the insights from the HTA literature to the policy evaluation frameworks, with discussion of the implications for HTA in genetic screening.Results and Conclusions: A critical discussion in the HTA literature considers the definition of ELSIs in HTA, highlighting the importance of thinking beyond ELSIs as impacts of technology. Existing HTA guidance on integrating ELSIs relates to three broad approaches: literature synthesis, involvement of experts, and consideration of stakeholder values. The thirteen key policy evaluation frameworks relating to disease screening and public health genomics identified a range of ELSIs relevant to genetic screening. Beyond straightforward impacts of screening, these ELSIs require consideration of factors such as the social and political context surrounding policy decisions. The three broad approaches to addressing ELSIs described above are apparent in the screening/genomics literatures. In integrating these findings we suggest that the method chosen for addressing ELSIs in HTA for genetic screening may determine which ELSIs are prioritized; and that an important challenge is the lack of guidance for evaluating such methods. ..."
Savulescu, J. and G. Kahane (2008). "The Moral Obligation to Create Children with the Best Chance of the Best Life." Bioethics.
"ABSTRACT According to what we call the Principle of Procreative Beneficence (PB), couples who decide to have a child have a significant moral reason to select the child who, given his or her genetic endowment, can be expected to enjoy the most well-being. In the first part of this paper, we introduce PB, explain its content, grounds, and implications, and defend it against various objections. In the second part, we argue that PB is superior to competing principles of procreative selection such as that of procreative autonomy. In the third part of the paper, we consider the relation between PB and disability. We develop a revisionary account of disability, in which disability is a species of instrumental badness that is context- and person-relative. Although PB instructs us to aim to reduce disability in future children whenever possible, it does not privilege the normal. What matters is not whether future children meet certain biological or statistical norms, but what level of well-being they can be expected to have. ..."
Sheehan, K. (2006). "Consumer Friendly or Reader Hostile? An Evaluation of the Readability of DTC Print Ads." Health Mark Q 23(4): 1-16.
"The Food and Drug Administration requires advertisements promoting prescription drugs to be written in consumer friendly language. The purpose of this study is to examine the language of Direct-to-Consumer prescription drug advertisements to determine if such language is easy for consumers to read and understand. A series of advertisements for a variety of products, appearing in popular consumer magazines, were analyzed using the Flesch and Gunning-Fogg formulas to determine if DTC advertisements are more or less complex than other advertisements that consumers read today. Results indicate that DTC ads are among the most difficult print ads to read. Additionally, certain types of information contained in these print ads (such as information discussing a drug's risks and contraindications) are significantly more difficult to read than information in any other type of ad copy in magazines today. Implications for DTC marketers and the FDA are included. ..."
"This paper takes a critical look at progress and prospects regarding the sociology of pharmaceuticals over the years. Key themes examined include: (i) medicalisation and pharmaceuticalisation; (ii) regulation; (iii) consumption and consumerism; (iv) expectations and innovation. Papers in the monograph are also introduced and discussed in relation to these themes. The paper concludes with some further comments and reflections on progress and prospects in this field, emphasising the continuing importance of sociological engagement with these personal and political issues in the 21st century. ..."
Stanta, G., A. Cescato, et al. (2008). "Bioethical considerations on medical research using human tissues: the researcher's viewpoint." Pathologica 100(2): 67-75.
"ObjectiveTo analyse legislation and medical professionals' position concerning the doctor's role in assisted reproduction techniques in Italy, and to discuss the implications for physicians of preimplantation genetic diagnosis (PGD). BackgroundUntil recently a strict interpretation of the assisted reproduction law (40/2004) and the guidelines subsequently issued, lead to denying infertile couples affected by genetic diseases the right to resort to PGD. In October 2006 the Constitutional Court ruled regarding the question of the constitutional legitimacy of the prohibition of PGD. DiscussionThe Constitutional Court declared the manifest inadmissibility of the question of the constitutional legitimacy of article 13 of law 40/2004. The debate has become very animated since the ruling. After the negative sentence of the Constitutional Court, three further sentences recognised the right of couples to obtain PGD, representing a hard blow to law 40/2004 and to the ministerial guidelines; a further confirmation of the untenability of a law that violates fundamental principles such as the right to healthcare for women and the unborn child, the right to responsible motherhood and to informed consent. ConclusionIt seems that in Italy the legislative inadequacy for medically assisted procreation is reprieved by the courageous decisions of the judges, which refer to the values of the Italian Constitution, in defence of the fundamental rights of the citizens. ..."
"Polemicists and disciplinary puritans commonly make a sharp distinction between the normative, prescriptive philosophical work of bioethicists and the empirical, descriptive work of anthropologists and sociologists studying medicine, healthcare, and illness. Though few contemporary medical anthropologists and sociologists of health and illness subscribe to positivism, the legacy of positivist thought persists in some areas of the social sciences. It is still quite common for social scientists to insist that their work does not contain explicit normative analysis, offers no practical recommendations for social reform or policy making, and simply interprets social worlds ..."
"Objective To describe the design, recruitment and baseline characteristics of participants in a community pharmacy based pharmacogenetic study of antihypertensive drug treatment. I Furthermore, cases more often used beta-blockers and calcium-antagonists, whereas controls more often used thiazide diuretics, ACE-inhibitors, and angiotensin-II receptor blockers. We have demonstrated that it is feasible to select patients from a coded database for a pharmacogenetic study and to approach them through community pharmacies, achieving reasonable response rates and without violating privacy rules. ..."
Wang, J. F., D. Q. Wei, et al. (2008). "Pharmacogenomics and personalized use of drugs." Curr Top Med Chem 8(18): 1573-9.
"As the development of the Human Genome Project (HGP), the sequencing of whole human genome has been completed, and a series of human genes have been detected, both of which result in the naissance of pharmacogenomics. Pharmacogenomics is the study of how an individual's genetic inheritance affects the body's response to drugs using the information of human genomics and bioinformatics approaches. It is not only propitious to the rational use of drugs, but also in favor for the personalized drug design. ..."
"<p>In the United States, health disparities have been framed by categories of race. Racial health disparities have been documented for cardiovascular disease, cancer, diabetes, HIV/AIDS, and numerous other diseases and measures of health status. Although such disparities can be read as symptoms of disparities in healthcare access, pervasive social and economic inequities, and discrimination, some have suggested that the disparities might be due, at least in part, to biological differences based on race. Or, to be more precise, if race itself has no determined biological meaning, race may nonetheless be a proxy that collects a group of individuals who share certain physiological or genotypic features that affect health.</p> ..."
"This article analyzes a number of recently published autobiographies by leading participants in the Human Genome Project (HGP), in order to determine to what extent they may further our understanding of the history, scientific significance and societal impact of this major research endeavor. Notably, I will focus on three publications that fall under this heading, namely The common thread by John Sulston (2002/2003), The language of God (2006) by Francis Collins and A life decoded by Craig Venter (2007). Autobiographies may reveal how this shift - usually discussed in more general terms from a philosophy of science or science studies perspective - manifests itself on an individual scale, on a micro-epistemological level. On the political level, autobiographies may inform us about the micro-politics of scientific change. Finally, on the level of Self, autobiographies may allow us to analyze how researchers, through practices of Self, are actively engaged in constituting themselves as responsible subjects in the face of unpredictable dynamics and unforeseen dilemmas. ..."
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