This Week in CGREAL

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

September 14 , 2007 

Home * Genetics in the News * Genetics in the Literature * Archive

Genetics in the News

Scientists highlight benefits of genetic research in sport, but warn of ethical concerns"Genetic research into athletic ability should be encouraged for its potential benefits in both sport and public health ..."

A Genetic Test That Very Few Need, Marketed to the Masses (New York Times) "But the commercial, sponsored by Myriad Genetics, is stirring protests from some cancer and genetics specialists, and it has brought on an inquiry by Connecticut s attorney general. . ..."

Therapy on trial (Nat Med) "The death of a participant in a gene therapy trial has thrown the entire field into question–as it did once before in 1999. Can the field survive this second setback? ..." [Related: MIT works toward safer gene therapy]

DNA helps pave the way for a specific cure for each individual "The advisory was one of a series of recent FDA communications about the role of individual genetics in determining whether a treatment decision will be effective, safe - or potentially deadly. ..."

Pioneering study catalogs ethical issues of scientific research in developing world "The first comprehensive examination of the ethical, social and cultural (ESC) challenges faced by major science programs in developing countries has identified a complex assortment of issues with the potential to slow critical global health research if left unaddressed. ..."

In Lebanon DNA may yet heal rifts - Yahoo! News "A Lebanese scientist following the genetic footprint of the ancient Phoenicians says he has traced their modern-day descendants, but stumbled into an old controversy about identity in his country. ..."  [Related:  Foundation Completes Major DNA Collection Effort in Mongolia "A non-profit scientific organization developing the world's largest online repository of correlated genetic and family history information, today announced that it has completed a major Mongolia DNA collection initiative. ..."]

The Genetics Forum "DNA Direct and MedHelp have introduced an online genetics forum where anyone can participate. DNA Direct’s certified genetic counselor, Lisa Kessler, will be leading the forum and will personally answer all questions. ..."

Bioethics for a century of human enhancement "There is nothing "brave" or beautiful about the biotechnised world we are entering, says one of America's best-known bioethicists. ..."

Study Finds Evidence of Genetic Response to Diet - New York Times "Could people one day evolve to eat rich food while remaining perfectly slim and svelte? ..."

How Do You Like Your Genes? Biofabs Take Orders (New York Times)"Such biofabs produce made-to-order genes, the stretches of DNA that contain the instructions for living creatures. ..."

Men shed light on the mystery of human longevity, study finds"It turns out that older men chasing younger women contributes to human longevity and the survival of the species ..."

The man who will help you live for 1,000 years ( Times Online) "Want to live for a millennium? It could be achieved with cellular technology, says Dr Aubrey de Grey ..."  [Related: How red wine magic ingredient aims to beat diseases of ageing (Times) "A small trial will test resveratrol, a chemical that could lead to a whole family of new drugs with powerful effects against the diseases of ageing. .."]

Bone marrow transplant paper revives contentious debate on fertility (Nat Med) "Researcher claims adult females can make new eggs. ..."

A genome in the garden of England (Telegraph) "This year, once again, we will be entering the contest for the Best Kept Village DNA Database. ..."

Building Genetic Medicine: A Discussion with STS and Public Policy Scholar Shobita Parthasarathy (The World's Fair) "Shobita Parthasarathy is particularly interested in developing democratically engaged policy solutions to deal with the challenges posed by ethically and socially controversial technologies. ..."

Google's Genetic Start-Up (Forbes) "Flatley talked about Illumina's partnership with 23andMe, a start-up that has raised about $10 million in venture capital. .."

Arsenic patent keeps drug for rare cancer out of reach of many (Nat Med)

"Patent should never have been granted, critics charge. ..."

NAS Makes 150 Years of Scientific Research Available Online "The National Academy of Sciences (NAS) is making 150 years of American scientific history available by publishing its entire collection of Biographical Memoirs on the Internet. ..."

 

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Genetics in the Literature

(2007). "Uninformed consent?" Nat Med 13(9): 999-999. "The US should revamp rules on informed consent to ensure that people have all of the information and support they need before deciding to enroll in clinical trials. ..."

Bell, J. A. (2007). "Preventing Post-Traumatic Stress Disorder or Pathologizing Bad Memories?" The American Journal of Bioethics 7(9): 29 - 30.

Beyleveld, D. and M. J. Taylor (2007). "Data protection, genetics and patents for biotechnology." Eur J Health Law 14(2): 177-87.

Feuchtbaum, L., G. Cunningham, et al. (2007). "Questioning the Need for Informed Consent: A Case Study of California's Experience with a Pilot Newborn Screening Research Project." Journal of Empirical Research on Human Research Ethics 2(3): 3-14."In 2001, the Genetic Disease Branch was mandated to pilot test a new technology that could identify many additional disorders using the same blood specimen already collected. Study participation required informed consent, which was obtained for 47% of births during the study timeframe. Several empirical questions are posed and each is examined from the perspective of society, the parents and the newborn. It is concluded that the legitimate needs of society and the interests of newborns should not be sacrificed to respond to the autonomy interests of the few parents who did not wish their infant to participate in the study, and that in the future, parental consent should be waived for projects evaluating new screening technologies. ..."

Hall, A. L. (2006). "Whose Progress? The Language of Global Health." Journal of Medicine and Philosophy 31(3): 285 - 304. "Yet through an interrogative consideration of two episodes in the marketing of progress, namely the Century of Progress Exposition in Chicago (1933&1934) and one post-war spin on atomic development in the National Geographic, I suggest that the language of medical advancement continues to trade on a division between civilized, rational, scientifically developed peoples and the atavism of peoples by whom Western science gauges its progress. I recommend unremittingly self-critical attention to the dynamics of language and legitimization used within the Western academy by those who seek ostensibly to be of use in regions (powerfully) labeled as "developing" ..."

Harvey, M. (2007). "Animal Genomics in Science, Social Science and Culture." Genomics, Society and Policy 3(2): 1-28.

"I show that animal genomics not only updates and extends established debates about the use of animals in science and society, but also raises novel issues and promotes new ways of thinking about what animals are, and the social and biological relationships between animals and humans. Organising the science of interest into six themes (sameness, difference and classification; crossing boundaries; the maintenance of borders; farmyard supermodels; laboratory supermodels; knowing, relating and looking at animals), for each I review some of the science that is being done, some of the conceptual issues that are raised, and some of the social science that is or could be done. I conclude by briefly considering the development of socially responsive policies for animal genomics. ..."

 

Helft, P. R., V. L. Champion, et al. (2007). "Cancer Patients' Attitudes Toward Future Research Uses of Stored Human Biological Materials." Journal of Empirical Research on Human Research Ethics 2(3): 15-22. "Cancer patients who contributed leftover tissue to the University Cancer Center Tissue Bank under such conditions were recruited for a mail survey study of their attitudes. Our findings suggest that a clear majority of subjects would permit unlimited future research on stored HBMs without re-contact and reconsent, and a significant minority appear to desire ongoing control over future research uses of their tissue. These differences merit further investigation and suggest that a policy of blanket consent for all future, unspecified research would be premature. ..."

Helgesson, G., J. Dillner, et al. (2007). "Ethical framework for previously collected biobank samples." Nat Biotech 25(9): 973-976.

Hemminki, K., J. Sundquist, et al. (2007). "How common is familial cancer?" Ann Oncol: mdm414. "Proportions of site-specific familial cancers (familial proportions) were calculated using the Swedish Family-Cancer Database, the largest dataset of its kind in the world, with cancers from the Swedish Cancer Registry. Prostate cancer showed the highest familial proportion of 20.15%, followed by breast (13.58%) and colorectal (12.80%) cancers. Salivary gland cancers showed the lowest familial proportion of 0.15%, but bone, laryngeal, anal, connective tissue and other genital cancers also remained <1%. The familial proportion depended on the prevalence of the particular cancer and on its familial risk. ..."

Henry, M., J. R. Fishman, et al. (2007). "Propranolol and the Prevention of Post-Traumatic Stress Disorder: Is it Wrong to Erase the "Sting" of Bad Memories?" The American Journal of Bioethics 7(9): 12 - 20."When administered immediately after a psychic trauma, propranolol is efficacious as a prophylactic for PTSD. Use of such memory-altering drugs raises important ethical concerns, including some futuristic dystopias put forth by the President's Council on Bioethics. We think that adequate informed consent should facilitate ethical research using propranolol and, if it proves efficacious, routine treatment. Clinical evidence from studies should certainly continue to evaluate realistic concerns about possible ill effects of diminishing memory. If memory-attenuating drugs prove effective, we believe that the most immediate social concern is the over-medicalization of bad memories, and its subsequent exploitation by the pharmaceutical industry. ..."

Johnson, P. and R. Williams (2007). "European securitization and biometric identification: the uses of genetic profiling." Ann Ist Super Sanita 43(1): 36-43."Among the wide variety of available biometric schemes, DNA profiling is regarded as a key method for discerning and recording embodied individuality. This paper discusses the current limitations on the use of DNA profiling in civil identification practices and speculates on future uses of the technology with regard to its interoperability with other biometric databasing systems. ..."

Jones, O. D. (2007). "Behavioral Genetics and Crime, in Context." LAW AND CONTEMPORARY PROBLEMS 69: 81-100. "Part II attempts to situate behavioral genetics, criminal law, and their overlap within larger contexts of law and biology. Part III attempts to situate the inquiries of this symposium issue within the context of work to date on behavioral genetics and crime. It also provides a brief summary of views, gleaned from a variety of different sources, on which itappears the majority of relevant scientists and commentators have reached at least tacit agreement. Part IV then outlines some of the complications and implications of discussing behavioral genetics and crime, including definitional and methodological challenges, as well as implications for free will and responsibility. Finally, Part V raises two issues worth exploring. The first concerns how the respective contributions of behavioral genetics and behavioral ecology will compare over time, and how those efforts might best be joined. The second issue concerns what it would mean to put environmental considerations and genetic considerations on equal footing in the criminal justice system—and whether such a thing would be desirable. ..."

 

Klein, R. D. (2007). "Gene patents and genetic testing in the United States." Nat Biotech 25(9): 989-990. "As genetic testing moves into mainstream medicine, its restriction by gene patent holders will have far-reaching, detrimental effects on the healthcare system. ..."

Krekels, E. H., J. N. van den Anker, et al. (2007). "Pharmacogenetics and paediatric drug development: issues and consequences to labelling and dosing recommendations." Expert Opin Pharmacother 8(12): 1787-99."Clinical research in children poses unique issues from a practical and technical perspective, but many challenges can be overcome by applying advanced study design and data analysis methods. When investigating the role of PGt factors on treatment effect, all features that influence drug response must be taken into account. Yet, PGt often has a privileged status in research protocols, with PGt factors evaluated independently from other determinants of response, instead of being regarded as other demographic or clinical covariates (e.g., age, renal function). At present, guidelines to incorporate PGt findings into label statements are lacking in part because this is a new and incompletely understood area. This situation is no longer acceptable. To achieve the potential that PGt can offer to drug development and ultimately to drug prescription, academia, industry and regulatory agencies need to pool resources on the revision of study design and data analysis requisites, bringing in model-based methodologies to enable accurate interpretation of results and provide appropriate labelling recommendations. ..."

Lucast, E. K. (2007). "INFORMED CONSENT AND THE MISATTRIBUTED PATERNITY PROBLEM IN GENETIC COUNSELING." Bioethics 21(1): 41-50. "A frequent suggestion is to include the risk of discovering nonpaternity in the informed consent process for counseling. In this paper I argue that such a move does not resolve the problem, because the conflict hinges on the interpretation of equality on which the counselor operates. Given the principles of genetic counseling, neither construal of equality yields a satisfactory solution to the conflict. In fact, I conclude that including nonpaternity in informed consent is not endorsed by either view, and we are still left with the question of what to do should nonpaternity be discovered. I suggest a compromise position concerning disclosure, involving revealing relevant genetic information but withholding nonpaternity when possible. ..."

Matsui, K., R. K. Lie, et al. (2007). "Two Methods of Obtaining Informed Consent in a Genetic Epidemiological Study: Effects on Understanding." Journal of Empirical Research on Human Research Ethics 2(3): 39-48. "THIS STUDY EVALUATED THE EFFECT ON participant understanding and participation rates of two different approaches to obtaining informed consent, using 2,192 actual research subjects in a genetic cohort study. One group received the routine approach consisting of written materials and an oral explanation. The other group received a more intense approach consisting of educational lectures and group meetings in addition to the routine approach. Subjects in the intense approach group were relatively more likely to read some or all of the explanatory material. Those in the intense group who did not read the material were more likely than those in the routine group to express uncertainty about their understanding of the research. Those in the intense group who read the material perceived that they had a higher level of understanding of the research and this was associated with a higher frequency of volunteering to participate. In contrast, subjects in the routine group were less likely to read the written material, but ironically more likely to assume that they understood what the research was about. These rather paradoxical findings raised questions about what motivates potential research subjects to become sufficiently engaged to seek actual understanding of the research before volunteering. ..."

Muszkat, M. (2007). "Interethnic Differences in Drug Response: The Contribution of Genetic Variability in [beta] Adrenergic Receptor and Cytochrome P4502C9." Clin Pharmacol Ther 82(2): 215-218.

Niebroj, L. T. (2006). "Genetic medicine: Polish deontological guidelines and the ethical practice of research studies with children." Hum Reprod Genet Ethics 12(1): 3-12."The purpose of the article is: (1) to describe deontological guidelines which regulate medical research involving human subjects in Poland, and (2) to clarify the understanding of the fundamental ethical concepts presented in these documents. To do this, two main documents are analysed: (1) the Polish Medical Ethics Code, and (2) the Good Practice in Science, a set of rules concerning scientists, approved by the Committee of Ethics of the Polish Academy of Science in 2001. The pluralism of contemporary ethics and of medical ethics in particular, results in various interpretations of the understanding of the crucial terms used in the deontological statements of these codes. The paper suggests that clarity in the understanding of the terms may be achieved by exploring the 'intellectual' context in which the analysed documents have been appearing and in which they are presently functioning. . ..."

Rothstein, H. (2006). "The institutional origins of risk: A new agenda for risk research." Health, Risk &amp; Society 8(3): 215 - 221. "This editorial, however, argues that contemporary preoccupations with risk are driven less by a changing distribution of real, or imagined, ills in society, than by a changing distribution of ills in governance. It argues that the inevitable difficulty of managing threats to society (societal risks) creates threats to organizations managing those risks (institutional risks). This editorial outlines how the institutional dynamics of contemporary governance can lead to a phenomenon of "risk colonization", whereby risk increasingly comes to define the object, methods and rationale of governance. It then goes on to consider some of the possible positive and negative consequences of risk colonization and concludes by suggesting ways in which the study of institutional risk can help us understand the relationship between risk and governance. ..."

Sade, R. M. (2007). "On Moralizing and Hidden Agendas: The Pot and the Kettle in Political Bioethics." The American Journal of Bioethics 7(9): 42 - 43.

Schroeder, D. (2007). "Benefit sharing: it's time for a definition." J Med Ethics 33(4): 205-209. "In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity. ..."

Sieber, J. E. (2007). "Respect for Persons and Informed Consent: "A Moving Target." Journal of Empirical Research on Human Research Ethics 2(3): 1-2. "Cancer patients who contributed leftover tissue to the Indiana University Cancer Center Tissue Bank under such conditions were recruited for a mail survey study of their attitudes. Our findings suggest that a clear majority of subjects would permit unlimited future research on stored HBMs without re-contact and reconsent, and a significant minority appear to desire ongoing control over future research uses of their tissue. These differences merit further investigation and suggest that a policy of blanket consent for all future, unspecified research would be premature. ..."

Tenenbaum, E. M. and B. Reese (2007). "Memory-Altering Drugs: Shifting the Paradigm of Informed Consent." The American Journal of Bioethics 7(9): 40 - 42.

Weitlauf, J. C., J. I. Ruzek, et al. (2007). "Empirically Assessing Participant Perceptions of the Research Experience in a Randomized Clinical Trial: The Women's Self-Defense Project as a Case Example." Journal of Empirical Research on Human Research Ethics 2(2): 11-24.

White, M. T. (2007). "Uncertainty and moral judgment: the limits of reason in genetic decision making." J Clin Ethics 18(2): 148-55.

Zeisel, S. H. (2007). "Nutrigenomics and metabolomics will change clinical nutrition and public health practice: insights from studies on dietary requirements for choline." Am J Clin Nutr 86(3): 542-548. "If nutrition studies could better identify responders and differentiate them from nonresponders on the basis of nutrigenomic or metabolomic profiles, the sensitivity to detect differences between groups could be greatly increased, and the resulting dietary recommendations could be appropriately targeted. It is not certain that nutrition will be the clinical specialty primarily responsible for nutrigenomics or metabolomics, because other disciplines currently dominate the development of portions of these fields. However, nutrition scientists' depth of understanding of human metabolism can be used to establish a role in the research and clinical programs that will arise from nutrigenomic and metabolomic profiling. Investments made today in training programs and in research methods could ensure a new foundation for clinical nutrition in the future. ..."

 

 

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