This Week in CGREAL

a newsletter of the Center for Genetic Research Ethics & Law in the Department of Bioethics, Case Western Reserve University

June 16, 2009 

Home * Archive

Genetics in the News

Every Genome - Illumina, Inc "Illumina is launching a personal genome sequencing service. At $48,000, the cost is half of the current best commercial offering on the market ($99,000 from Knome). ..."

European Genetics Group Offers Draft of Genetic Testing Oversight | GenomeWeb Daily News | DxPGx | GenomeWeb "The European Society of Human Genetics has issued a draft version of proposed recommendations for regulating and managing genetic testing and will be accepting public comments about its proposals until the beginning of July. ..."

FSU study links 'warrior gene' to gang membership, weapon use "Boys who carry a particular variation of the gene Monoamine oxidase A (MAOA), sometimes called the "warrior gene," are more likely not only to join gangs but also to be among the most violent members and to use weapons ..."

Material World: Protected: Open access materials for teaching research ethics "The NIH training course ... is ill-suited for training anthropologists for the kinds of ethical dilemmas they will encounter in the field. The basic model of “human subjects research” that it assumes is one of clinical research, but the intricate and intimate relationships that develop during ethnographic research raise dilemmas that are nearly unthinkable in a clinical encounter ..."

U.S. GAO - Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation "The IRB system is vulnerable to unethical manipulation, which elevates the risk that experimental products are approved for human subject tests without full and appropriate review. ..."

Technology Review: Making Fat Disappear "Engineering mice with a fat-burning strategy from bacteria keeps the animals thin. ..."

Gene Doctors Milk Mice; Yield Human Breast Milk Protein "Thanks to human genes spliced into their genome, the mice are the first genetically modified animals to produce lactoferrin. ..."

Horse whisperers, lion tamers not needed: Scientists find genetic regions that soothe savage beasts "In what could be a breakthrough in animal breeding, a team of scientists from Germany, Russia and Sweden have discovered a set of genetic regions responsible for animal tameness ..."

Individuals with family history of genetic disease at risk of discrimination"People with a family history of genetic disease are often discriminated against by insurance companies and their relatives and friends, according to research published on bmj.com today. ..."

Risks of sharing personal genetic information online need more study, Stanford bioethicists say "Bonding over a similar genetic background sounds relatively harmless. But according to bioethicists from the Stanford University School of Medicine, sharing genetic information online raises a host of ethical questions. ..."

What the Cow Genome Tells Us § SEEDMAGAZINE.COM "The work performed by the Bovine Genome Sequencing and Analysis Consortium and the Bovine HapMap Consortium promises to revolutionize cattle breeding, lead to critical advances in biomedical research, and offer potential insight into the production of alternative fuel. ..."

Technology Review: Blogs: TR Editors' blog: Genetic Tests on the Horizon "The latest in genetic testing from the Consumer Genetics Conference ..."

Bioethics Discussion Blog: Another Ethical Dilemma: Organ Donation and Paternity Discovery "The dilemma of this unexpected paternity discovery is what should be done with the information the physicians have obtained? ..."

Comment: Human subjects have human rights - New Scientist "An allegation that a prosperous first-world scientist has intentionally or carelessly maligned powerless people in the developing world naturally tempts us to stand alongside the underdog, and condemn the researcher. Yet there may equally well be convincing explanations that put matters in a different light. ..."

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Genetics in the Literature

 

(2009). "Genetic privacy and piracy." Nat Cell Biol 11(5): 509-509.

(2009). "The genome-assisted barnyard." Nat Biotech 27(6): 487-487.

"In contrast to the slow translation of human genome information into medicine, animal genomics is likely to have a rapid and tangible impact on agriculture. ..."

Angrist, M. (2009). "We Are the Genes We've Been Waiting For: Rational Responses to the Gathering Storm of Personal Genomics." The American Journal of Bioethics 9(6): 30 - 31.

Arnett, D. K., S. A. Claas, et al. (2009). "Has pharmacogenetics brought us closer to 'personalized medicine' for initial drug treatment of hypertension?" Current Opinion in Cardiology 24(4): 333-339.

"Purpose of review: To describe recent advances in antihypertensive pharmacogenetics and discuss challenges related to translating this knowledge into 'personalized medicine' for the initial drug treatment of hypertension. Recent research in antihypertensive pharmacogenetics has added to the existing evidence base, and novel genes and variants as well as new methodologies are cause for continued optimism. However, translation of genomic science to clinical settings has not kept pace with growing interest in personalized medicine for hypertension. New research paradigms may be needed to translate pharmacogenetics into clinical tools. Clinical application will also require a trained clinical workforce, validated genetic tests, and payers willing to fund pretreatment testing.,. ..."

Belmont, J. and A. L. McGuire (2009). "The futility of genomic counseling: essential role of electronic health records." Genome Med. 1(5): 48.

"Technological advances over the past several years have dramatically reduced the cost of whole-genome sequencing. At the same time, understanding of the functional significance of genetic variation has advanced considerably. The routine generation of whole-genome sequence data for individual patients will soon be sufficiently cost-effective for widespread clinical integration. Yet, the clinical utility of whole-genome data is currently limited by an inability to effectively process, store, interpret and update genomic data, while at the same time protecting patient privacy. Enter the electronic health record. We propose that without the integration of a dynamic uniform electronic health record, counseling patients on the basis of genome-wide data will be futile. ..."

Bombard, Y., G. Veenstra, et al. (2009). "Perceptions of genetic discrimination among people at risk for Huntington's disease: a cross sectional survey." BMJ 338(jun08_3): b2175-.

"Objective To assess the nature and prevalence of genetic discrimination experienced by people at risk for Huntington's disease who had undergone genetic testing or remained untested. Design Cross sectional, self reported survey. Setting Seven genetics and movement disorders clinics servicing rural and urban communities in Canada. Participants 233 genetically tested and untested asymptomatic people at risk for Huntington's disease (response rate 80%): 167 underwent testing (83 had the Huntington's disease mutation, 84 did not) and 66 chose not to be tested. Main outcome measures Self reported experiences of genetic discrimination and related psychological distress based on family history or genetic test results. Results Discrimination was reported by 93 respondents (39.9%). Reported experiences occurred most often in insurance (29.2%), family (15.5%), and social (12.4%) settings. There were few reports of discrimination in employment (6.9%), health care (8.6%), or public sector settings (3.9%). Although respondents who were aware that they carried the Huntington's disease mutation reported the highest levels of discrimination, participation in genetic testing was not associated with increased levels of genetic discrimination. Family history of Huntington's disease, rather than the result of genetic testing, was the main reason given for experiences of genetic discrimination. Psychological distress was associated with genetic discrimination (P<0.001). Conclusions Genetic discrimination was commonly reported by people at risk for Huntington's disease and was a source of psychological distress. Family history, and not genetic testing, was the major reason for genetic discrimination. ..."

 

Borry, P., H. Howard, et al. "Health-related direct-to-consumer genetic testing: a review of companies’ policies with regard to genetic testing in minors." Familial Cancer.

"Considering the ethical, legal, and psychological concerns surrounding genetic testing in minors, a study of companies’ websites was performed in order to describe and analyze their policies with respect to this issue. Of the 29 companies analyzed, 13 did not provide any information about this matter, eight companies allowed genetic testing upon parental request, four companies stated that their website is not directed to children under 18&nbsp;years, and four companies suggested that in order to be tested, applicants should have reached the age of legal majority. If private companies offer genetic tests which are also offered in a clinical setting, can they be expected to adhere to the existing clinical guidelines with regard to these tests? If so, a certain ambiguity exists. Many companies are emphasizing in their disclaimers that their services are not medical services and should not be used as a basis for making medical decisions. Nonetheless, it remains debatable whether genetic testing in minors would be appropriate in this context. In line with the Advisory Committee on Genetic Testing, the Human Genetics Commission addressed the problem of non-consensual testing and recommended not to supply genetic testing services directly to those under the age of 16 or to those not able to make a competent decision regarding testing. ..."

Bunnik, E., A. C. J. W. Janssens, et al. (2009). "How Attitudes Research Contributes to Overoptimistic Expectations of Personal Genome Testing." The American Journal of Bioethics 9(6): 23 - 25.

Caulfield, T. (2009). "Direct-To-Consumer Genetics and Health Policy: A Worst-Case Scenario?" The American Journal of Bioethics 9(6): 48 - 50.

Cole, A. (2009). "Patients should opt in to schemes where their medical data are shared, say GPs' representatives." BMJ 338(jun15_1): b2441-.

Esposito, K. and K. Goodman (2009). "Genethics 2.0: Phenotypes, Genotypes, and the Challenge of Databases Generated by Personal Genome Testing." The American Journal of Bioethics 9(6): 19 - 21

Fromkin, D. (2009). "Regulating laboratory-developed tests." Nat Biotech 27(5): 421-421.

Greenbaum, D. and M. Gerstein (2009). "Social Networking and Personal Genomics: Suggestions for Optimizing the Interaction." The American Journal of Bioethics 9(6): 15 - 19.

Guessous, I., M. Gwinn, et al. (2009). "Genome-wide association studies in pharmacogenomics: untapped potential for translation." Genome Med. 1(4): 46.

" Despite large public investments in genome-wide association studies of common human diseases, so far, few gene discoveries have led to applications for clinical medicine or public health. Genome-wide association studies in the context of clinical trials of drug safety and efficacy may be quicker to yield clinical applications. Certain methodological concerns, such as selection bias and confounding, may be mitigated when genome-wide association studies are conducted within clinical trials, in which randomization of exposure, prospective evaluation of outcome and careful definition of phenotype are incorporated by design. ..."

Hall, W. and C. Gartner (2009). "Direct-to-Consumer Genome-Wide Scans: Astrologicogenomics or Simple Scams?" The American Journal of Bioethics 9(6): 54 - 56.

 

Henrikson, N. B., D. Bowen, et al. (2009). "Does genomic risk information motivate people to change their behavior?" Genome Med. 1(4): 37.

" The recent flood of information about new gene variants associated with chronic disease risk from genome-wide association studies has understandably led to enthusiasm that genetic discoveries could reduce disease burdens and increase the availability of direct-to-consumer tests offering risk information. However, we suggest caution: if it is to be any benefit to health, genetic risk information needs to prompt individuals to pursue risk-reduction behaviors, yet early evidence suggests that genetic risk may not be an effective motivator of behavior change. It is not clear how genetic information will inform risk-based behavioral intervention, or what harms might occur. Research is needed that examines the behavioral consequences of genetic risk knowledge in the context of other motivators and social conditions, as well as research that determines the subgroups of people most likely to be motivted, in order to inform policy decisions about emerging genetic susceptibility tests. Without such research, it will not be possible to determine the appropriate health care uses for such tests, the impact on health care resources from consumer-initiated testing, or the criteria for truthful advertising of direct-to-consumer tests. ..."

Holm, S. r. (2009). "Kon's Reinvention of the Empirical Bioethics Wheel." The American Journal of Bioethics 9(6): 69 - 70.

Howard, H. C. and P. Borry (2009). "Personal Genome Testing: Do You Know What You Are Buying?" The American Journal of Bioethics 9(6): 11 - 13.

Hsu, A. R., J. L. Mountain, et al. (2009). "A Pragmatic Consideration of Ethical Issues Relating to Personal Genomics." The American Journal of Bioethics 9(6): 1 - 2.

Jones, D. A. (2009). "What does the British public think about human-animal hybrid embryos?" J Med Ethics. 35(3): 168-70.

"In the recent UK debate on the Human Fertilisation and Embryology Bill, there have been conflicting claims about the extent of public support for, or opposition to, human-animal hybrids. Self-selecting polls tend to show opposition to hybrids. Representative-sample polling shows spontaneous opposition but can elicit conditional approval of research, combined with underlying unease. Public opinion is very finely divided, with people generally opposed to this research unless it is likely to lead to medical advances. ..."

Jordens, C. F. C., I. H. Kerridge, et al. (2009). "Direct-to-Consumer Personal Genome Testing: The Problem Is Not Ignorance–It Is Market Failure." The American Journal of Bioethics 9(6): 13 - 15.

Kon, A. A. (2009). "The Role of Empirical Research in Bioethics." The American Journal of Bioethics 9(6): 59 - 65.

"There has long been tension between bioethicists whose work focuses on classical philosophical inquiry and those who perform empirical studies on bioethical issues. While many have argued that empirical research merely illuminates current practices and cannot inform normative ethics, others assert that research-based work has significant implications for refining our ethical norms. In this essay, I present a novel construct for classifying empirical research in bioethics into four hierarchical categories: <i>Lay of the Land, Ideal Versus Reality, Improving Care</i>, and <i>Changing Ethical Norms</i>. Through explaining these four categories and providing examples of publications in each stratum, I define how empirical research informs normative ethics. I conclude by demonstrating how philosophical inquiry and empirical research can work cooperatively to further normative ethics. ..."

Lee, S. S.-J. and L. Crawley (2009). "Research 2.0: Social Networking and Direct-To-Consumer (DTC) Genomics." The American Journal of Bioethics 9(6): 35 - 44.

"The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information (PGI) direct-to-consumers. Companies such as 23andme (Mountain View, CA) and Navigenics (Foster City, CA) are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking business ventures that market the science of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information—openly sharing of data with all interested parties, not just the biomedical researcher—for the purposes of pooling data (increasing statistical power) and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis. ..."

Lemoine, F. o. M. (2009). "Cell and Gene Therapy: Hope and Despair, but at Least Medical Progress." Human Gene Therapy 20(6): 551.

 

MacDonald, C. and N. Walton (2009). "Personal Genomics: Democratization, or Empowerment, or ‘Something’." The American Journal of Bioethics 9(6): 46 - 48.

 

Mahendran, M. "Clinical Genomics Data Use: Protecting Patients Privacy Rights." Studies in Ethics, Law, and Technology 3(1).

Malm, H. (2009). "Genetic Privacy: Might There Be a Moral Duty to Share One's Genetic Information?" The American Journal of Bioethics 9(6): 52 - 54.

 

Mascalzoni, D., A. Hicks, et al. "Consenting in Population Genomics as an Open Communication Process." Studies in Ethics, Law, and Technology 3(1)

"New advances in genomics changed the research landscape significantly in the last few years. The power and significance of already existing tissue collections is enhanced by their growing size, and all over the world national projects aim to connect with each other at the international level, calling for integrated and common regulations in the transnational research field. The post genomics era faces problems that are partially different from those within the classical bioethical framework. The challenge is to find new ways to deal with regulations in order to facilitate research without frustrating personal rights. Informed Consent has been the center of this wide debate. We propose a model for rethinking consent in an open-time/open-goal framework suitable to genomics research. Consensus becomes more than a single legal step and goes more in the direction of a participated governance mechanism, a circular open process of communication which the IC sheet signature is just one instance of. This approach provides a governance framework based on different levels of consensus and participation that already contains mechanisms to resolve conflicts between different instances and to protect both the interest of research and the rights of participants. ..."

McGuire, A. L., C. M. Diaz, et al. (2009). "Social Networkers' Attitudes Toward Direct-to-Consumer Personal Genome Testing." The American Journal of Bioethics 9(6): 3 - 10.

"Purpose: This study explores social networkers' interest in and attitudes toward personal genome testing (PGT), focusing on expectations related to the clinical integration of PGT results. Methods: An online survey of 1,087 social networking users was conducted to assess 1) use and interest in PGT; 2) attitudes toward PGT companies and test results; and 3) expectations for the clinical integration of PGT. Descriptive statistics were calculated to summarize respondents' characteristics and responses. Results: Six percent of respondents have used PGT, 64% would consider using PGT, and 30% would not use PGT. Of those who would consider using PGT, 74% report they would use it to gain knowledge about disease in their family. 34% of all respondents consider the information obtained from PGT to be a medical diagnosis. 78% of those who would consider PGT would ask their physician for help interpreting test results, and 61% of all respondents believe physicians have a professional obligation to help individuals interpret PGT results. Conclusion: Respondents express interest in using PGT services, primarily for purposes related to their medical care and expect physicians to help interpret PGT results. Physicians should therefore be prepared for patient demands for information and counsel on the basis of PGT results. ..."

Newson, A. J. (2009). "Personal Genomics as an Interactive Web Broadcast." The American Journal of Bioethics 9(6): 27 - 29.

O'Connor, D. (2009). "Apomediation and the Significance of Online Social Networking." The American Journal of Bioethics 9(6): 25 - 27.

Paul, M. F. (2009). "Newborn Screening for Genetic Disorders." Pediatric clinics of North America 56(3): 505-513.

"Newborn screening has become an integral part of the evaluation of more than 4 million newborns a year in the United States and of most newborns in industrialized countries and many in developing countries. Because the term “newborn screening” refers to many procedures performed in a nursery such as screening for hearing loss or congenital heart disease, this discussion is limited to screening for genetic or congenital disorders with blood spotted on filter paper cards. This discussion reflects primarily the experiences and current status of NBS programs in the United States. ..."

Reid, L. (2009). "Networking Genetics, Populations, and Race." The American Journal of Bioethics 9(6): 50 - 52.

Resnik, D. B. (2009). "Direct-to-Consumer Genomics, Social Networking, and Confidentiality." The American Journal of Bioethics 9(6): 45 - 46.

Sheehan, M. (2008). "Is gene therapy for the treatment of male infertility ethical?" Nat Clin Pract Urol 5(11): 596-597.

Sugarman, J., N. Kass, et al. (2009). "Categorizing Empirical Research in Bioethics: Why Count the Ways?" The American Journal of Bioethics 9(6): 66 - 67.

Tabor, H. K. and M. Kelley (2009). "Challenges in the Use of Direct-to-Consumer Personal Genome Testing in Children." The American Journal of Bioethics 9(6): 32 - 34.

Tibben, A. (2009). "Genetic discrimination in Huntington's disease." BMJ 338(jun08_3): b1281-

Walko, C. M. and H. McLeod (2009). "Pharmacogenomic progress in individualized dosing of key drugs for cancer patients." Nat Clin Prac Oncol 6(3): 153-162.

Wasson, K. (2009). "Direct-to-Consumer Genomics and Research Ethics: Should a More Robust Informed Consent Process Be Included?" The American Journal of Bioethics 9(6): 56 - 58.

Wilkinson, R., H. "The Single Equality Bill: A Missed Opportunity to Legislate on Genetic Discrimination?" Studies in Ethics, Law, and Technology 3(1)

"New advances in genomics changed the research landscape significantly in the last few years. The power and significance of already existing tissue collections is enhanced by their growing size, and all over the world national projects aim to connect with each other at the international level, calling for integrated and common regulations in the transnational research field. The post genomics era faces problems that are partially different from those within the classical bioethical framework. The challenge is to find new ways to deal with regulations in order to facilitate research without frustrating personal rights. Informed Consent has been the center of this wide debate. We propose a model for rethinking consent in an open-time/open-goal framework suitable to genomics research. Consensus becomes more than a single legal step and goes more in the direction of a participated governance mechanism, a circular open process of communication which the IC sheet signature is just one instance of. This approach provides a governance framework based on different levels of consensus and participation that already contains mechanisms to resolve conflicts between different instances and to protect both the interest of research and the rights of participants. ..."

Wynia, M. K. (2009). "Answering the "So What?" Question for Empirical Research in Bioethics." The American Journal of Bioethics 9(6): 68 - 69.

 

 

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