This Week in CGREAL

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

May 16, 2007 

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

Genetics in the News

Draft Guidelines for Human Biobanks and Genetic Research Databases
The OECD is inviting comments on the draft Guidelines for Human Biobanks and Genetic Research Databases. The deadline for submitting comments is 16th May 2008.

Genomic Applications in Practice and Prevention (GAPP):  Translation Programs in Education, Surveillance, and Policy  CDC's National Office of Public Health Genomics announces a new funding opportunity for genomics translation in education, surveillance, and policy interventions. The deadline for final applications is June 6, 2008. 

Genetic Information Nondiscrimination Act clears Senate"The Senate passed the Genetic Information Nondiscrimination Act (GINA) on April 24, approving by unanimous consent an amended version of H.R. 493, which passed the House April 25, 2007 by a vote of 420-3. The House is expected to take up the measure again quickly before sending it to President Bush to sign the measure into law. ..."  [Related:  "Genetic Discrimination: Unfair or Natural? - TIME "That's a good instinct, and this new weapon in the arsenal of equality is a good thing. But how far should we take it? ..."Genetics bill cruises through Senate : Nature News "Unanimous vote welcomed by personal genomics companies. ..."Guest commentary: Nice to meet you, GINA. I've heard so much about you "All of that may be true, but all of it is trumped by perception: people fear genetic discrimination, which is what makes this new law so historic. ..." How to Get a Genetic Protection Law Through Congress? Keep Trying "Representative Louise Slaughter (D-NY) has pushed a ban on DNA-based discrimination through 13 years of congressional debate. ..."  Insurance based on genetics: a questionable proposition "In the wake of the bill's passage, however, a number of people have questioned why it shouldn't be an employer's or insurer's right to make decisions based on genetics. ..."]

American College of Medical Genetics makes genetic testing recommendations in new policy statement"What the public needs to know about direct-to-consumer genetic tests ..." [Related:  "Enter Navigenics, Where Personal Genomics Gets More Medical | Wired "Today marks another entrant in the personal genomics game: Navigenics, the much anticipated startup out of Redwood Shores, California, is open for business. ..."  23andMe and The Parkinson's Institute Announce Initiative to Advance Parkinson's Disease Research "Partnership Seeks to Develop and Validate Web-Based Assessment Tools to Revolutionize the Way Parkinson's Disease Clinical Studies are Conducted ..."  Personal Health Records » Another privacy threat: personal genome projects "What if a unauthorized person get access to the 23andme database? ..."  Genetics firm to build online health database "The Google-backed consumer genome service 23andMe staked out a role in the growing medical database industry Wednesday, announcing that it will collaborate with Parkinson's disease researchers to collect key information from patients in an all-online format. ..."]

Genetic testing gains ground as safeguards increase - Fort Worth Business Press "Genetic testing is gaining ground as laws are being tweaked to safeguard information about a patient s genes, health care officials said. ..."[Related: "  Genetic Snake Oil? | Newsweek "A new report calls for increased FDA scrutiny of the genetic testing industry. ..." Why You Don't Want To See Your Genetic Scorecard - Courant.com "It all sounds so good. If you have a couple of thousand dollars to part with (along with some saliva), why not have one of these companies scan your genome? ..." You 2.0: Closing the Genetic Gap "The question is: As new, direct-to-consumer genetic testing sites begin delivering this fresh and sometimes incomplete DNA news to customers online, how will Big Medicine and government regulators react? And how will they shape what DNA testing sites look like? ..."]

Feds to Collect Millions of DNA Profiles Yearly, Stay Out if You Can | Wired.com "The feds will soon be collecting about one million DNA samples a year under a new program that lets federal agents collect cheek swabs from citizens merely arrested for any federal crime or from any non-citizen detained by federal agents -- including visitors to the country who have visas. ..." [Related: From DNA of Family, a Tool to Make Arrests - washingtonpost.com"Privacy Advocates Say the Emerging Practice Turns Relatives Into Genetic Informants ..."]

FDA Signals High Bar for Stem Cell Treatments "At a meeting yesterday, the chief of the FDA s cell and tissue therapy branch said data from clinical trials of the treatments may need to be particularly strong to persuade the agency ..."  [Related: FDA to take key stem-cell step "The Food and Drug Administration looks like it's bowing to the inevitable this week and drawing the blueprint for the first-ever human experiments with human embryonic stem cells. ..." Doctors accused of doing illegal stem-cell trials : Nature News "An apparently successful stem-cell treatment for urinary incontinence is now being questioned after it has emerged that clinical trials for the therapy may have been done illegally. ..."  ]

Health Blog : JAMA Commentary Pans FDA Proposal to Ease Off-Label Rules "The FDA s proposed guidelines to allow drug makers to pass around articles from medical journals that discuss unapproved uses of their drugs is a bad idea ..."

8 new human genome projects offer large-scale picture of genetic difference | Think Gene "A nationwide consortium led by the University of Washington in Seattle has completed the first sequence-based map of structural variations in the human genome, giving scientists an overall picture of the large-scale differences in DNA between individuals. The project gives researchers a guide for further research into these structural differences, which are believed to play an important role in human health and disease. ..."

Beth Kohl: Genetics and the Politics of Discrimination - Living on The Huffington Post "Rather, it provides for one more incredibly powerful tool in the healthcare arsenal, a tool that should be wielded by the individual and paid for by the insurer as a prophylactic and, ultimately, cost-minimizing technique. ..."

A Big Day For Genetic Genealogists - A New Y-DNA Tree And The New SNP Test » The Genetic Genealogist "The International Society of Genetic Genealogy (ISOGG) announced today that their Tree Team has completed the 2008 version of the Y-DNA Haplogroup Tree. ..."

Blood Matters - Masha Gessen - Book Review - New York Times "But scrawled within it, too, are clues about our future, which can be downright terrifying. Rather than expand our sense of possibilities, they foreshorten them. There are dread mutations slumbering in our cells. From our genes, we learn how we may die. ..."

Can DNA tests reveal a criminal mind? - Washington Post "These "second generation" DNA tests seek to shed light on the biological traits and psychological states of the accused. In effect, they allow genes to "testify" in ways never before possible, in some cases resolving long-standing legal tangles but in others raising new ones. ..."

Davenport's Dream: 21st Century Reflections on Heredity & Eugenics "Cold Spring Harbor Laboratory Press has just published Davenport's Dream: 21st Century Reflections on Heredity & Eugenics, edited by Jan Witkowski and John Inglis. The book reprints Charles Davenport's Heredity In Relation to Eugenics, a book long out of print and a classic in human genetics and eugenics. The reprint is accompanied by ten essays written by, among others, Elof Carlson, Ronald Dworkin and Lewis Wolpert. ..."

Dawn of human matrilineal diversity "A team of Genographic researchers and their collaborators have published the most extensive survey to date of African mitochondrial DNA (mtDNA). ..."

Fraud attempt in a paternity test modifies action protocol in DNA tests "The referred case gains a special importance as this is the first time it has been described that someone has mixed two types of saliva in order to alter a DNA test ..." [Related: DDC Announces New 3-Day Turnaround Time for DNA Paternity Tests " marks a major achievement in the DNA testing industry, where a 5 working-day turnaround time is the standard for paternity tests. ..."

Doping in sport | Economist.com "An athlete's genes may help determine the results of his dope test ..." [Related: Some Athletes Genes Help Outwit Doping Test - New York Times "It was, researchers say, a striking demonstration of a genetic discovery. Those 17 men can build muscles with testosterone, they respond normally to the hormone, but they are missing both copies of a gene used to convert the testosterone into a form that dissolves in urine. The result is that they may be able to take testosterone with impunity. ..."]

Drug Makers Near Old Goal: A Legal Shield - New York Times "But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product ..."

The FAQs about the human genome "A new handbook, A Short Guide to the Human Genome, answers these and other commonly asked questions. ..."

Genes Explain Race Disparity in Response to a Heart Drug - New York Times "Doctors who treat patients with heart failure have long been puzzled by a peculiar observation. Many black patients seem to do just as well if they take a mainstay of therapy, a class of drugs called beta blockers, as if they do not. It is almost as if they were immune to the drugs. ..."

Genetic Future: The elusive genetics of bipolar disorder "Bipolar disease is a common and profoundly debilitating mood disorder, with a remarkably strong genetic component. These features have made bipolar an appealing target for geneticists; yet despite three large genome-wide association studies, the genetic basis of this disease remains as elusive as ever. ..."

Institutional Review Blog: Researchers Honored for Harming Human Subjects "Since at least the 1970s, IRB critics have asked why such work is honored when a reporter does it but condemned--at least by IRBs--when a scholar is asking the questions. ..."

Longevity quest moves slowly from lab to life - Buying Time?- msnbc.com "Don't bank on anti-aging pills anytime soon unless you're a worm ..."

Medical research should include more women participants and examine the role of gender in disease "When Drs. Rogers and Ballantyne looked at the type of research in which men and women participated, they discovered that male participants were more than three times as likely to be involved in research into conditions affecting both men and women. Other data provided by the Australian team indicates that gender-specific reporting of results in women is particularly lacking in pharmaceutical research. ..."

The Mission of Navigenics: Interview « ScienceRoll "Dr. Dietrich Stephan, a human geneticist at Navigenics, agreed to answer some of my questions. ..."

The Newly-Created DNA Fund » The Genetic Genealogist "The DNA Fund, (www.dnafund.org), a new non-profit organization has been established to fund DNA testing scholarships and grants for ancestral DNA studies. ..."

Redefining Disease, Genes and All - New York Times "Just as they once mapped the human genome, scientists are trying to map the diseasome, the collection of all diseases and the genes associated with them. ..."

'Ruthlessness gene' discovered : Nature News "Dictatorial behaviour may be partly genetic, study suggests. ..."

Same-sex couples could create children - Telegraph "A scientific technique that could allow same-sex couples to create their own biological child in a laboratory should be allowed under law, a group of influential scientists said ..."

Scientist team creates first GM human embryo - Times Online "Scientists have created what is believed to be the first genetically modified (GM) human embryo.A team from Cornell University in New York produced the GM embryo to study how early cells and diseases develop. It was destroyed after five days. ..."

'Now we have the technology that can make a cloned child' - Science, News - The Independent "A new form of cloning has been developed that is easier to carry out than the technique used to create Dolly the sheep, raising fears that it may one day be used on human embryos to produce "designer" babies. ..."

Scientists find a fingerprint of evolution across the human genome "The Human Genome Project revealed that only a small fraction of the 3 billion letter DNA code actually instructs cells to manufacture proteins, the workhorses of most life processes. This has raised the question of what the remaining part of the human genome does. ..."

Scientists Form International Cancer Genome Consortium - National Institutes of Health (NIH) "Research organizations from around the world announced today they are launching the International Cancer Genome Consortium (ICGC), a collaboration designed to generate high-quality genomic data on up to 50 types of cancer through efforts projected to take up to a decade. ..."

Should storing cord blood be standard? "Public or private? That's the controversial question being asked about a potentially life-saving practice in which cord blood -- the blood collected from a newborn's placenta and umbilical cord -- is stored for future use. ..."

Stem Cells From Menstrual Blood Show Therapeutic Potential - Examiner.com "Cryo-Cell International, Inc. today announced results of a study published this month in Cell Transplantation showing that stem cells found in menstrual blood proliferate rapidly and have significant potential to develop into multiple cell types. ..."

The Stupidity of Dignity"Conservative bioethics' latest, most dangerous ploy. ..."

Genetically Altered Trout Approved for Release in U.K "Plans to pour tankfuls of genetically altered fish into wild lakes and rivers have been given the go-ahead in the United Kingdom after conservation scientists backed the project. ..."

---

Genetics in the Literature

 

(2008). "Getting embryonic stem cell therapy right." Nat Med 14(5): 467-467.

 

(2008). "Association between genetic variant and susceptibility to nicotine dependence found." Pharmacogenomics 9(5): 497-499.

 

Allison, M. (2008). "Is personalized medicine finally arriving?" Nat Biotech 26(5): 509-517.

"It's no gold rush, but dozens of players are emerging in personalized medicine, with biotechs, big and small, leading the way. Some big pharma companies and even payers remain skeptical, but economics aside, the real winners will be patients. ..."

Anderson, G. (2008). "Ethical preparedness and performance of gene therapy study co-ordinators." Nurs Ethics 15(2): 208-21.

"The purposes of this study were to: (1) describe characteristics of co-ordinators of gene therapy (transfer) clinical trials; (2) assess differences between nurse and non-nurse study co-ordinators; and (3) identify factors indicative of study co-ordinators' role preparation that could affect their role performance. The findings contribute to knowledge by identifying present inadequacies in the training of study co-ordinators and in recognizing the need for more effective provision of orientation and continuing education with respect to ethical issues, knowledge of genetic science, and potential research integrity challenges. ..."

Ankum, W. M., J. B. Reitsma, et al. (2008). "IVF with preimplantation genetic screening, a promising new treatment with unexpectedly negative health outcomes: the Hippocratic role of Data Monitoring Committees." Hum. Reprod. 23(1): 1-3.

"A recently published randomized controlled trial showed preimplantation genetic screening (PGS) as part of an IVF programme to reduce ongoing pregnancy rates by 1/3 in comparison to the control group without PGS: rate ratio (RR) 0.69 (0.51-0.93), P = 0.01. A masked interim analysis already showed significant differences between treatment arms: RR 0.58 (0.35-0.94), P = 0.02. Despite this finding, the trial's Data Monitoring Committee decided not to stop, but to continue the trial. This paper argues why this decision was sound, since it was based on (i) explicit statistical criteria and (ii) the trade-off between risks and benefits for current and future IVF patients. The trial's findings confront the medical community once again with the general problem of new technologies being implemented without randomized evidence of effectiveness. ..."

 

Arribas-Ayllon, M., S. Sarangi, et al. (2008). "The micropolitics of responsibility vis-à-vis autonomy: parental accounts of childhood genetic testing and (non)disclosure." Sociology of Health & Illness 30(2): 255-271.h

"Interviews (n = 20) were conducted with parents whose genetic condition may have had consequences for their children. Using rhetorical discourse analysis, we show how parents draw upon a number of rhetorical/discoursal devices to produce accounts where genetic responsibility is actually or potentially transmitted to the child. We identify three kinds of accounting practice: (1) aligned responsibility; (2) deferred responsibility; and (3) misaligned responsibility. Each of these practices demonstrates how parents position themselves responsibly by foregrounding figures and events onto which the child's autonomy is selectively mapped. Rather than simple representations, we regard these accounts as complex moral performances that seek alignment with broader bioethical discourses. ..."

Arribas-Ayllon, M., S. Sarangi, et al. (2008). "Managing self-responsibility through other-oriented blame: Family accounts of genetic testing." Social Science & Medicine 66(7): 1521-1532.

"In this paper, we explore how forms of responsible selfhood are managed through accounts of other-oriented blame in the family sphere. Interviews (n =20) were conducted in the United Kingdom with parents whose genetic condition may have consequences for other family members. We conclude that claims of personal responsibility manifest in open disclosure of genetic information often entail the blaming of others within the family. By extension, blaming others has moral and relational significance when competing views of genetic responsibility are at stake and when genetic understandings are incongruent. ..."

 

Athar, S. (2008). "Enhancement Technologies and the Person: An Islamic View." J Law Med Ethics 36(1): 59-64.

 

Barranco Morris, M. and B. Morris (2008). "Personalized medicine and patient-centric learning: a core requirement for informed decision making." Personalized Medicine 5(3): 265-271.

 

Behar, D. M., R. Villems, et al. (2008). "The Dawn of Human Matrilineal Diversity." American journal of human genetics 82(5): 1130-1140.

 

Boneh, A., S. Allan, et al. "Clinical, ethical and legal considerations in the treatment of newborns with non-ketotic hyperglycinaemia." Molecular Genetics and Metabolism In Press, Corrected Proof.

"The medical-ethics approach is based on the principles of non-maleficence, beneficence, autonomy and justice. The law relating to withholding or withdrawing life-sustaining treatment is complex and varies between jurisdictions. Physicians treating newborns with NKH need to provide families with accurate and complete information regarding the disease and the relative probability of possible outcomes of the neonatal presentation and to explore the extent to which family members are willing to take part in the decision making process. Cultural and religious attitudes, which may potentially clash with bioethical and juridical principles, need to be considered. ..."

 

Borry, P., L. Stultiens, et al. (2008). "Minors and informed consent in carrier testing: a survey of European clinical geneticists." J Med Ethics 34(5): 370-374.

"A study was made of attitudes of clinical geneticists regarding the age at which minors should be allowed to undergo a carrier test and the reasons they provide to explain their answer. European clinical institutions where genetic counselling is offered to patients were contacted. 177 (63%) of the 287 eligible respondents answered a questionnaire. Clinical geneticists were significantly more in favour of providing a carrier test to a younger person if the request was made together with the parents than if the adolescent requested the test personally. Age is not the only decisive element when considering the participation of adolescents in decisions affecting their health. The clinical geneticists referred to cognitive, emotional and sexual maturity and the support of parents as crucial elements in their comments regarding when to tell children about their genetic risk or to allow adolescents to request a carrier test. ..."

 

Branford, R. A., P. Pantelidis, et al. (2008). "Ethnic Considerations in Pharmacogenetic Studies." J Clin Oncol 26(10): 1766-1767.

 

Bray, J., C. Clarke, et al. (2008). "Should we be "pushing meds"? The implications of pharmacogenomics." Journal of Psychiatric and Mental Health Nursing 15(5): 357-364.

"This paper recognizes the impact that pharmacogenomics and pharmacogenetics are having in the field of mental health. Variants in genes that code for the drug metabolizing enzymes in the liver have been found to influence the way in which these enzymes handle psychotropic medication. Individuals can be classified as poor, moderate or extensive metabolizers when standard regimes are used, and this can lead to huge differences in therapeutic effect and toxicity. There are now genotyping tests available which provide information on the individual's ability to metabolize psychotropic medication. One author provides an account of the effects of medication on her son's physical and psychological well-being. Genotyping provided evidence for his poor metabolism of psychotropic medication, and his life is now changing as he is being very gradually weaned off this medication. This emerging field of work has implications for the way in which practitioners consider medication adherence. ..."

 

Burgess, M., K. O'Doherty, et al. (2008). "Biobanking in British Columbia: discussions of the future of personalized medicine through deliberative public engagement." Personalized Medicine 5(3): 285-296.

 

Cappelen, A. W., O. F. Norheim, et al. (2008). "Genomics and equal opportunity ethics." J Med Ethics 34(5): 361-364.

"The aim of this paper is to explore implications of genomics from the perspective of equal opportunity ethics. The ideal of equal opportunity requires that individuals are held responsible for some, but not all, factors that affect their health. Informational problems, however, often make it difficult to implement the ideal of equal opportunity in the context of healthcare. In this paper, examples are considered of how new genetic information may affect the way individual responsibility for choice is assigned. It is also argued that genomics may result in relocation of the responsibility cut by providing both new information and new technology. Finally, how genomics may affect healthcare policies and the market for health insurance is discussed. ..."

 

Cupples, L. A. (2008). "Family study designs in the age of genome-wide association studies: experience from the Framingham Heart Study." Curr Opin Lipidol 19(2): 144-50.

"Here we discuss the role of family studies in modern genetics research, using results from the Framingham Heart Study as examples. Family-based study designs continue to contribute much to the modern era of genome-wide association studies. ..."

 

De Melo-Martín, I. (2008). "Genetic research and reduction of health disparities." New Genetics and Society 27(1): 57 - 68.

"The purpose of this paper is to evaluate whether genetic research is an adequate means to attain the very worthy goal of eliminating racial and ethnic healthcare inequalities. I argue that, in our present social and political context, even if genetic variation contributes to health disparities, and even if such knowledge allows us to develop new interventions, genetics and genomics research is unlikely to have any significant effect on their elimination or reduction. I explore also the possibility that attention to genetic research as the solution to persistent health inequalities might actually hinder our efforts to improve health status and healthcare outcomes for historically disadvantaged groups. ..."

Ehrich, K., C. Williams, et al. (2008). "The embryo as moral work object: PGD/IVF staff views and experiences." Sociol Health Illn.

"We report on one aspect of a study that explored the views and experiences of practitioners and scientists on social, ethical and clinical dilemmas encountered when working in the field of preimplantation genetic diagnosis (PGD) for serious genetic disorders. The study produced an ethnography based on observation, interviews and ethics discussion groups with staff from two PGD/IVF Units in the UK. We focus here on staff perceptions of work with embryos that entails disposing of 'affected' or 'spare' embryos or using them for research. ..."

 

El-Ibiary, S. Y., C. Cheng, et al. (2008). "Potential roles for pharmacists in pharmacogenetics." J Am Pharm Assoc (2003) 48(2): e21-29; quiz e30-32.

 "OBJECTIVES: To highlight areas of pharmacogenetics in which pharmacists may play a role and to describe those roles in the context of specific examples from a major academic medical center. As drug therapy experts, pharmacists are in a unique position to push the frontiers of pharmacogenetics in both the research and clinical practice environments. ..."

Felt, U., M. Fochier, et al. (2008). "Visions and Versions of Governing Biomedicine: Narratives on Power Structures, Decision-making and Public Participation in the Field of Biomedical Technology in the Austrian Context." Social Studies of Science (Sage) 38(2): 233-257.

"Building on focus group data collected in Austria within the framework of a European project, this paper explores lay people's visions and versions of government, governance and participation for two biomedical technologies: post-natal genetic testing and organ transplantation. Building on this analysis, we show that people situate their assessments of public participation against the background of rather complex lay models of the governance and government of the respective technology. Because these models are very different for the two technologies, participation also had very different connotations, which were deeply intertwined with each socio-technical system. Building on these findings we argue for a more technology-sensitive approach to public participation. ) ..."

 

Foster, M. W. and R. R. Sharp (2008). "Out of sequence: how consumer genomics could displace clinical genetics." Nat Rev Genet 9(6): 419-419.

 

Garrison, L. P., R. J. Carlson, et al. (2008). "A Review of Public Policy Issues in Promoting the Development and Commercialization of Pharmacogenomic Applications: Challenges and Implications." Drug Metabolism Reviews 40(2): 377 - 401.

"This article reviews the regulatory, social, policy, and other issues that will shape the development of pharmacogenomics applications. We identify and analyze 19 key public policy issues, ranging from the economic incentives for linked diagnostic-drug development, to the regulation of tests and drugs, and to privacy and informed consent. Challenging technical, business, and policy-related issues might either hinder progress in the field of pharmacogenomics or potentially accelerate it, depending on how they are addressed and resolved. How well the numerous important stakeholders—both private and public—address these issues will be critical for pharmacogenomics to deliver on its promise. ..."

 

Gilbar, R. (2007). "Patient autonomy and relatives' right to know genetic information." Med Law 26(4): 677-97.

"A comparative analysis of English and Israeli medical law reveals that the doctors' duty is based on two principles: a liberal perception of patient autonomy and an overriding utilitarian principle of prevention of harm. However, socio-medical research indicates that these principles do not entirely reflect the views of patients and doctors and are too narrow to deal with the complex situations in practice. Thus, it is argued that the doctor's legal duty of confidentiality should be reconsidered and qualified when it concerns the family. ..."

 

Gleicher, N., A. Weghofer, et al. (2008). "Preimplantation genetic screening: "established" and ready for prime time?" Fertility and Sterility 89(4): 780-788.

"Unless attempts to improve pregnancy rates and/or diminish miscarriage rates through preimplantation genetic screening (PGS) are applied to only carefully selected patients, they will fail. Because specific PGS indications have remained undefined, PGS should be considered an experimental procedure ..."

Goering, S., S. Holland, et al. (2008). "Transforming Genetic Research Practices with Marginalized Communities: A Case for Responsive Justice." Hastings Center Report 38(2): 43-53.

"The article presents a case for responsive justice in genetics research with marginalized communities. In doing so, it considers the application of John Rawls' concept of distributive justice in genetic medicine and research. Standard research models use distributive justice in designing and conducting research. However, this approach often excludes underserved and marginalized populations in the process. Recognition, redistribution and responsibility are the guiding principles to creating responsive justice in genetics research with marginalized communities...."

 

Green, R. M. (2008). "Are babies by design in our future?" Personalized Medicine 5(3): 273-277.

 

Harvey, O. (2008). "Regulating stem cell research and human cloning in an Australian context: the Lockhart Review." New Genetics & Society 27(1): 33-42.

"The years between the initialization of the legislation and the outcome of the review process have resulted in some significant transformations in how stem cell science and human cloning are viewed in Australia. This paper will discuss those changes and the shift in attitude they represent. ..."

 

Hausman, D. M. (2007). "Group risks, risks to groups, and group engagement in genetics research." Kennedy Inst Ethics J 17(4): 351-69.

"This essay distinguishes between two kinds of group harms: harms to individuals in virtue of their membership in groups and harms to "structured" groups that have a continuing existence, an organization, and interests of their own. Genetic research creates risks of causing both kinds of group harms, and engagement with the groups at risk can help to mitigate those harms. The two kinds of group harms call for different kinds of group engagement. ..."

 

Haussecker, D. "The Business of RNAi Therapeutics." Human Gene Therapy 0(0): 1-12.

 

Herring, R. J. (2008). "Opposition to transgenic technologies: ideology, interests and collective action frames." Nat Rev Genet 9(6): 458-463

"The framing of agricultural products of recombinant DNA technology as GMOs lacks biological coherence, but has proved to be a powerful frame for opposition. Disaggregating the concept of the 'GMO' is a necessary condition for confronting misconceptions that constrain the use of biotechnology in addressing imperatives of development and escalating challenges from nature, especially in less-industrialized nations. ..."

 

Hoop, J. G., L. W. Roberts, et al. "Psychiatrists' Attitudes Regarding Genetic Testing and Patient Safeguards: A Preliminary Study." Genetic Testing 0(0).

"This probability sample of U.S. psychiatrists expressed a strongly positive view of genetic testing in psychiatry, while voicing nearly unanimous support for seven ethical and legal safeguards. ..."

 

Hugh, W. (2008). "The forensic use of DNA: Scientific success story, ethical minefield." Biotechnology Journal 3(3): 303-305.

 

Humphreys, L., M. Cappelli, et al. (2008). "The Role of Women's Relationships With Their Partners in Their Adjustment Following Prenatal Genetic Testing." Journal of Applied Social Psychology 38(2): 482-512.

"This study explored how aspects of the couple relationship contributed to the adjustment of 95 women who underwent prenatal diagnostic (PND) testing because of advanced maternal age (AMA). ..."

 

Jackson, F. L. C. (2008). "Ethnogenetic layering (EL): an alternative to the traditional race model in human variation and health disparity studies." Annals of Human Biology 35(2): 121 - 144.

"This paper details the methods used in ethnogenetic layering (EL), a non-typological alternative to the current reliance of the biological racial paradigm in public health, epidemiology, and biomedicine. . ..."

 

Jansen, L. A. (2008). "Doctor vs. Scientist?" Hastings Center Report 38(2): 3-3.

"The article discusses the paper "Bench to Bedside: Mapping the Terrain of Research Ethics," by Steven Joffe and Franklin Miller. This paper situates clinical research on patient-subjects as part of a broader spectrum of activities that seek to improve human health. Joffe and Miller do not recommend a sharp distinction between therapeutic medicine and clinical research because it will lead to misunderstandings about the purpose of clinical research. For Joffe and Miller, the ethics of clinical research lies in "undue" risk on patient-subjects--clinical trials should not place patient-subjects on "undue" risk...."

 

Johnson, A. (2008). "Screening newborns: just the beginning. Newborn screening and tracking diagnosed children into adulthood varies among states." State Legis 34(4): 20-3.

 

Katz, R. V., S. S. Kegeles, et al. (2008). "Awareness of the Tuskegee Syphilis Study and the US Presidential Apology and Their Influence on Minority Participation in Biomedical Research." Am J Public Health: AJPH.2006.100131.

"We compared the influence of awareness of the Tuskegee Syphilis Study and the presidential apology for that study on the willingness of Blacks, non-Hispanic Whites, and Hispanics to participate in biomedical research.Methods. Adjusted multivariate analysis showed that, compared with Whites, Blacks were nearly 4 times as likely to have heard of the Tuskegee Syphilis Study, more than twice as likely to have correctly named Clinton as the president who made the apology, and 2 to 3 times more likely to have been willing to participate in biomedical studies despite having heard about the Tuskegee Syphilis Study.  These marked differences likely reflect the cultural reality in the Black community, which has been accustomed to increased risks in many activities. For Whites, this type of information may have been more shocking and at odds with their expectations and, thus, led to a stronger negative impact. ..."

 

Kemper, A. R., C. A. Boyle, et al. (2008). "Long-term follow-up after diagnosis resulting from newborn screening: statement of the US Secretary of Health and Human Services' Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children." Genet Med 10(4): 259-61.

"To begin to improve long-term follow-up, the Advisory Committee has identified its key features, including the assurance and provision of quality chronic disease management, condition-specific treatment, and age-appropriate preventive care throughout the lifespan of affected individuals. There are four components central to achieving long-term follow-up: care coordination through a medical home, evidence-based treatment, continuous quality improvement, and new knowledge discovery. ..."

 

Kenner, C., J. A. Lewis, et al. (2008). "Neonatal Genetic Testing is More Than Screening." Critical Care Nursing Clinics of North America 20(2): 233-237.

"Newborn screening practices have changed since breakthroughs have occurred in genetics and mapping of the human genome. Although newborn screening has been in existence since the 1960s, today's newborn screening practices are subsumed primarily under the umbrella of genetic testing. Inclusion of the family history tool is another dimension of neonatal assessment. Technology allows many noninvasive tests to be run at a low cost but with this advance comes ethical and legal dilemmas. This article discusses neonatal genetic testing and some of the ethical dilemmas that arise. ..."

 

Kermani, A. J., F. Fathi, et al. "Characterization and Genetic Manipulation of Human Umbilical Cord Vein Mesenchymal Stem Cells: Potential Application in Cell-Based Gene Therapy." Rejuvenation Research 0(0): 1-8.

"Umbilical cord vein is a readily available and inexpensive source of stem cells that are capable of generating various cell types. Despite the recent isolation of human umbilical cord vein mesenchymal stem cells (UVMSC), the self-renewal capacity and the potential clinical application of the cells are not well known. In the present study, we have successfully isolated and cultured human UVMSCs. ..."

 

Kirkland, R. (2008). ""Enhancing Life?" Perspectives from Traditional Chinese Value-Systems." J Law Med Ethics 36(1): 26-40.

 

Kotchetkova, I., R. Evans, et al. (2008). "Articulating Contextualized Knowledge: Focus Groups and/as Public Participation?" Science as Culture 17(1): 71 - 84.

"Calls for increased public participation in science and technology policy are now commonplace and raise challenges for social scientists as well as policy-makers. For social scientists, the practice of public participation raises questions about the methods used by social scientists to collect data and develop the representations of public opinion that inform this new dialogue but also reflect it. In this paper, the difference that different methods can make is illustrated by comparing the focus group data on perceptions of stem cell research with the more conventional survey based representations of public opinion. By examining how our data allow the uncertainty and ambivalence of participants to remain visible in its analysis, we argue that a more qualitatively informed social science can contribute to public debate in ways that go beyond the quantification of pro and anti positions that survey research appears to encourage. ..."

 

LaFleur, W. R. (2008). "Enhancement and Desire: Japanese Qualms about Where Biotechnology is Taking Us." J Law Med Ethics 36(1): 65-72.

 

Lundmark, P. E., U. Liljedahl, et al. (2008). "Evaluation of HapMap data in six populations of European descent." Eur J Hum Genet.

"We studied how well the European CEU samples used in the Haplotype Mapping Project (HapMap) represent five European populations by analyzing nuclear family samples from the Swedish, Finnish, Dutch, British and Australian (European ancestry) populations. ..."

 

Lustig, A. (2008). "Enhancement Technologies and the Person: Christian Perspectives." J Law Med Ethics 36(1): 41-50.

 

Lynch, J., J. Bevan, et al. (2008). "A preliminary study of how multiple exposures to messages about genetics impact on lay attitudes towards racial and genetic discrimination." New Genetics and Society 27(1): 43 - 56.

"Media depictions of genetics have led to concerns that this coverage will lead to increased belief in genetic determinism and increased discrimination, including racism. Previous studies of single exposures to messages about genetics or messages about genetics and race have shown some increases in discrimination and racism. Since attitude change is linked to repeated exposure to many messages, this study aimed to identify the effect of multiple exposures to multiple messages about genetics on attitudes towards determinism, discrimination and racism. Results showed an increase in genetically based racism, no increase in general racist affect and no significant increase in belief in determinism. Based on these results, we suggest that genetically based racism is a combination of racist affect with belief that perceived differences in human characteristics are solely or primarily influenced by genetics and that a move towards genetically based racism has implications for social policy. ..."

 

Maheu, C. and S. Thorne (2008). "Receiving inconclusive genetic test results: An interpretive description of the BRCA1/2 experience." Res Nurs Health.

"We examined the experience of 21 women diagnosed with breast or ovarian cancer who received inconclusive BRCA1/2 genetic test results. Although these women received similar information on the technical meaning of an inconclusive result, their interpretations of personal risk for a probable, inherited cancer mutation differed. Their interpretations ranged from confidence that they probably carried an undetected gene mutation to believing that their cancer had no genetic basis. Women drew from their personal experience with genetic testing and from distinctive perceptions and beliefs in attempting to understand their test results; they variously drew upon such evidence as observations of similarities and differences within familial breast/ovarian cancer patterns to explain their ultimate conclusions as to their own genetic status. . ..."

 

Martin, P., N. Brown, et al. (2008). "From Bedside to Bench? Communities of Promise, Translational Research and the Making of Blood Stem Cells." Science as Culture 17(1): 29 - 41.

"In this paper we critically explore the changing relationships between the bench and the bedside through the development of haematopoietic stem cells (HSCs). . ..."

 

Mason, C. and P. Dunnill (2008). "The strong financial case for regenerative medicine and the regen industry." Regenerative Medicine 3(3): 351-363.

Matimba, A., M. N. Oluka, et al. (2008). "Establishment of a biobank and pharmacogenetics database of African populations." Eur J Hum Genet.

 

McCabe, L. L. and E. R. B. McCabe (2008). "Expanded Newborn Screening: Implications for Genomic Medicine." Annual Review of Medicine 59(1): 163-175.

"Newborn screening (NBS) represents the largest volume of genetic testing. The 45-year history of NBS has demonstrated its benefits, as well as the importance of an evidence base. The recent addition of tandem mass spectrometry (MS/MS) resulted in a fivefold increase in the number of tests. Experience with MS/MS also showed that laboratory tests are just one part of the NBS system. The lessons learned from NBS will provide important insights as we move into the predictive, preventive, and personalized era of genomic medicine. ..."

 

McGuire, A. L. (2008). "1000 Genomes: on the road to personalized medicine." Personalized Medicine 5(3): 195-197.

 

McWilliam, A., R. Lutter, et al. (2008). "Healthcare impact of personalized medicine using genetic testing: an exploratory analysis for warfarin." Personalized Medicine 5(3): 279-284.

 

Miller, F. A., M. Giacomini, et al. (2008). "When research seems like clinical care: a qualitative study of the communication of individual cancer genetic research results." BMC Med Ethics 9: 4.

"Our findings suggest that the hybrid state created through the disclosure of research results about individuals that are perceived to be clinically relevant may produce neither sufficiently adequate clinical care nor sufficiently ethical research practices. These findings raise questions about the extent to which research can, and should, be made to serve clinical purposes, and suggest the need for further deliberation regarding any ethical obligation to communicate individual research results. ..."

 

Morrow, T. (2008). "Personalized medicine complicates medical decision-making." Manag Care 17(2): 59-60.

 

Nebert, D. W., G. Zhang, et al. (2008). "From Human Genetics and Genomics to Pharmacogenetics and Pharmacogenomics: Past Lessons, Future Directions." Drug Metabolism Reviews 40(2): 187 - 224.

"A brief history of human genetics and genomics is provided, comparing recent progress in those fields with that in pharmacogenetics and pharmacogenomics, which are subsets of genetics and genomics, respectively. It remains unclear whether personalized medicine or individualized drug therapy will ever be achievable by means of DNA testing alone. ..."

 

Norton, M. E. (2008). "Genetic screening and counseling." Curr Opin Obstet Gynecol 20(2): 157-63.

"Advances in genetic testing have resulted in tremendous benefits to patients, and challenges to providers. New approaches to education and counseling are needed to assure that all patients receive a complete and balanced review of their prenatal genetic-testing options. ..."

 

Nycum, G. and L. Reid (2007). "The harm-benefit tradeoff in "bad deal" trials." Kennedy Inst Ethics J 17(4): 321-50.

"This paper examines the nature of the harm-benefit tradeoff in early clinical research for interventions that involve remote possibility of direct benefit and likelihood of direct harms to research participants with fatal prognoses, by drawing on the example of gene transfer trials for glioblastoma multiforme. We argue that the appeal made by the component approach to clinical equipoise fails to account fully for the nature of the harm-benefit tradeoff-individual harm for social benefit-that would be required to justify such research. ..."

 

Reich, D., A. L. Price, et al. (2008). "Principal component analysis of genetic data." Nat Genet 40(5): 491-492.

"Principal component analysis (PCA) has been a useful tool for analysis of genetic data, particularly in studies of human migration. A new study finds evidence that the observed geographic gradients, traditionally thought to represent major historical migrations, may in fact have other interpretations. ..."

 

Rieder, M. J., R. J. Livingston, et al. (2008). "The Environmental Genome Project: Reference Polymorphisms for Drug Metabolism Genes and Genome-Wide Association Studies." Drug Metabolism Reviews 40(2): 241 - 261.

"Herein, we review a subset of Phase I cytochrome P450 genes studied by the EGP, approaches to GWAS, and the sensitivity of available genotyping platforms to capture common sequence variation in this subset of drug metabolism genes. ..."

 

Robert, D. and M. Dufresne (2008). "The social uses of DNA in the political realm or how politics constructs DNA technology in the fight against crime." New Genetics and Society 27(1): 69 - 82.

"This paper will focus on DNA technology and the meanings and expectations invested into it by actors who participated in the debate surrounding two bills on DNA identification in Canada. Through this process, we will uncover the symbolic conditions that allowed for the introduction of the National DNA Databank as a crime-fighting tool: first, the minimization of the power of the substance and the idealization of the DNA databank potentialities; second, the scientification and professionalization of the police through DNA; and third, the reconciliation of Canada's two identities, that of the criminal justice innovator and human rights defender. Those are some of the key symbolic elements that made the creation and expansion of the DNA databank possible. ..."

 

Rubin, B. P. (2008). "Therapeutic Promise in the Discourse of Human Embryonic Stem Cell Research." Science as Culture 17(1): 13 - 27.

"This paper highlights the work done by the therapeutic promise in initiating an alliance between bioethics and science in an endeavour that both shaped and ensured the continuation of hESC research. ..."

 

Sadelain, M. and D. A. Williams (2008). "A Vector Drain in US Gene Therapy Development?." Mol Ther 16(5): 801-802

 

Schrag, Z. M. "How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965-1991." Journal of Policy History forthcoming.

"This article draws on previously untapped manuscript materials in the National Archives to trace the history of the federal regulation of social science research. Officials raised sincere concerns about dangers to participants in social science research, especially the unwarranted invasion of privacy as a result of poorly planned survey and observational research. On the other hand, the application of the regulations to the social sciences was far less careful than was the development of guidelines for biomedical research. Regulators failed to define the problem they were trying to solve, then insisted on a protective measure borrowed from biomedical research without investigating alternatives. ..."

 

Scott, A. and R. Du Plessis (2008). "Redefining a technology: public and private genetic testing in Aotearoa New Zealand." Sociology of Health & Illness 30(3): 364-379.

"This paper draws on theory relating to the social shaping of technologies and the concept of technological scripts to offer a critical analysis of recent debate in Aotearoa New Zealand about private provision of genetic testing. An apparent ‘turf war’ between professionals about who will provide genetic tests obscures attention to a more serious issue – the redefinition of a technology. What is at stake is not just who will do the tests, but what technology is available – either genetic testing as a commodity, or an integrated set of genetic services. While focused on a particular national context, this paper addresses issues relevant to the provision of genetic services in other nation states characterised by a mixture of public and private provision of health services. ..."

 

Seguin, B., B.-J. Hardy, et al. (2008). "Genomic medicine and developing countries: creating a room of their own." Nat Rev Genet 9(6): 487-493.

"The notion that developing countries must wait for the developed world to make advances in science and technology that they later import at great cost is being challenged. We have previously argued that developing countries can harness human genetic variation to benefit their populations and economies. Based on our empirical studies of large-scale population genotyping projects in Mexico, India and Thailand, we describe how these resources are being adopted to improve public health and create knowledge-based economies. A significant additional benefit is building the capacity for scientific research and internalizing advances in technology, whatever their source. ..."

 

Spinney, L. (2008). "Scaled-up self-experimentation proposed." Nat Med 14(5): 471-471.

"Now a British biotech entrepreneur named William Bains is proposing that self-experimenters should form collectives, pooling resources to make their findings more acceptable to the mainstream scientific community. ..."

 

Stephens, N., P. Atkinson, et al. (2008). "The UK Stem Cell Bank: Securing the Past, Validating the Present, Protecting the Future." Science as Culture 17(1): 43 - 56.

"We analyse the centrality of trust, social networks, and wider public legitimacy in the Bank's work. It is important to recognize the ways in which the Bank makes these social relationships visible, and in some cases durable, through their embodiment in documentary form. These practices are essential to the Bank's particular vision of the future of stem cell science. ..."

 

Stoller, S. E. (2008). "Why We Are Not Morally Required to Select the Best Children: a Response to Savulescu." Bioethics.

"The purpose of this paper is to review critically Julian Savulescu's principle of 'Procreative Beneficence,' which holds that prospective parents are morally obligated to select, of the possible children they could have, those with the greatest chance of leading the best life. In this paper I argue that the examples that Savulescu employs to support his theory in fact fail to justify it. He presents these examples as analogous to PGD, when in fact they differ from it in subtle but morally relevant ways. Specifically, Savulescu fails to acknowledge the fact that his examples evoke deontological and virtue ethics concerns that are absent in the context of PGD. These differences turn out to be crucial, so that, in the end, the analogies bear little support for his theory. Finally, I lay out the implications of this analysis for reproductive ethics. ..."

 

Swen, J. J., I. Wilting, et al. (2008). "Pharmacogenetics: From Bench to Byte." Clin Pharmacol Ther 83(5): 781-787.

"Despite initial enthusiasm,the use of pharmacogenetics has remained limited to investigation in only a few clinical fields such as oncology and psychiatry.The main reason is the paucity of scientific evidence to show that pharmacogenetic testing leads to improved clinical outcomes. . ..."

 

van der Vorm, A., M. Olde Rikkert, et al. (2008). "Genetic research into Alzheimer's Disease: a European focus group study on ethical issues." International Journal of Geriatric Psychiatry 23(1): 11-15.

"The long-term results of genetic research into AD are expected to be positive while the short-term results seem likely to be negative. The perception of AD as a disease could be changed by the results from genetic research into AD, and this could have effects at the individual level (feelings of guilt and responsibility for one's own health).(1) The role of the family in genetic AD research differs from its role in other biomedical research into AD. The development of a family consent procedure might solve some informed consent problems. (2) Negative social consequences of genetic AD research are expected in the short term, but there are hopes of positive consequences in the long term. ..."

 

Vladutiu, G. D. (2008). "The FDA announces new drug labeling for pharmacogenetic testing: Is personalized medicine becoming a reality?" Molecular Genetics and Metabolism 93(1): 1-4.

 

Waldby, C. (2008). "Oocyte markets: women's reproductive work in embryonic stem cell research." New Genetics and Society 27(1): 19 - 31.

"Somatic cell nuclear transfer (SCNT) research, otherwise known as therapeutic cloning, requires large numbers of research oocytes, placing pressure on an already limited supply. In the UK, Canada, Australia, Singapore and most of Western Europe, oocytes are made available through modestly reimbursed donation, and, owing to the onerous nature of donation, the existing demand for reproductive oocytes far outstrips availability. SCNT research will place this system under even greater pressure. This paper investigates the growth in a global market for oocytes, where transnational IVF clinics broker sales between generally poor, female vendors and wealthy purchasers, beyond the borders of national regulation, and with little in the way of clinical or bioethical scrutiny. It considers the possible impact that SCNT research will have on this global market. It argues that oocyte vending could be understood as a kind of reproductive labor in the bioeconomy, and suggests some ways to improve the protection, security and power of vendors. ..."

 

Waldby, C. and B. Salter (2008). "Global Governance in Human Embryonic Stem Cell Science: Standardisation and Bioethics in Research and Patenting." Studies in Ethics, Law, and Technology 2(1).

"In this paper we examine an increasingly important form of global governance for the field of human embryonic stem cell science; the processes of standardisation. This paper examines this tension in two domains of standardisation: basic research (governance of the science) and patenting (governance of the market). . ..."

 

Wilcken, B. and V. Wiley (2008). "Newborn screening." Pathology 40(2): 104 - 115.

 

Williams, C., S. P. Wainwright, et al. (2008). "Human embryos as boundary objects? Some reflections on the biomedical worlds of embryonic stem cells and pre-implantation genetic diagnosis." New Genetics and Society 27(1): 7 - 18.

"In this paper we offer some reflections on embryos in the biomedical worlds of embryonic stem cells (ESC) and pre-implantation genetic diagnosis (PGD). We draw upon two ethnographic studies of the social practices of PGD and embryonic stem cell science to examine the notion of boundary objects as an approach for understanding the social construction of embryos. We analyze the ways in which human embryos have similar and different meanings in the related social worlds of ESC and PGD labs through a discussion of two major themes: the goals of PGD and ESC; and linking the worlds of ESC and PGD. ..."

 

Yesley, M. S. (2008). "What's ELSI got to do with it? Bioethics and the Human Genome Project." New Genetics and Society 27(1): 1 - 6.

"Two mechanisms for developing public policy in bioethics an independent commission and the ELSI of the Human Genome Project are discussed. The author, a private consultant, was staff director of the first US bioethics commission and coordinated the ELSI Program of the US Department of Energy at its outset. ..."

 

Yu, W., A. Wulf, et al. (2008). "HuGE Watch: tracking trends and patterns of published studies of genetic association and human genome epidemiology in near-real time." Eur J Hum Genet.

 

Zaneveld, J., P. J. Turnbaugh, et al. (2008). "Host-bacterial coevolution and the search for new drug targets." Current Opinion in Chemical Biology 12(1): 109-114.

"Here we review the evidence for coevolution between symbionts and their hosts, the role of horizontal gene transfer in coevolution, and genomic and metagenomic approaches to identify drug targets. . ..."

 

Zaninovic, N., J. Hao, et al. (2007). "Genetic modification of preimplantation embryos and embryonic stem cells (ESC) by recombinant lentiviral vectors: efficient and stable method for creating transgenic embryos and ESC." Fertility and Sterility 88(Supplement 1): S310-S310.

 

Zhang, W. and M. E. Dolan (2008). "Ancestry-related differences in gene expression: findings may enhance understanding of health disparities between populations." Pharmacogenomics 9(5): 489-492.

 

Zhang, W., M. J. Ratain, et al. (2008). "The HapMap Resource is Providing New Insights into Ourselves and its Application to Pharmacogenomics." Bioinform Biol Insights 2: 15-23.

"Recent progress in dissecting genetic contribution to natural variation in gene expression within and among human populations and variation in drug response are two examples in which researchers have utilized the HapMap resource. The HapMap Project provides new insights into the human genome and has applicability to pharmacogenomics studies leading to personalized medicine. ..."

Zodrow, J. J. (2008). "Reproductive Technology, Intent Parentage and Genetic "Manipulation" of Parental Roles." American Journal of Family Law 21(4): 112-125.

"The article discusses artificial reproduction technology (ART) with focus on parental role issues. Examples of alternative reproduction are given including sperm, egg and embryo donation, and artificial insemination. The cases of several couples' battle for parental rights are provided as references. Issues such as genetic origin disclosure and donor anonymity, surrogate and gestational motherhood, and multiple births and selective reduction of offspring are discussed. ..."

 

Zoloth, L. (2008). "Go and Tend the Earth: A Jewish View on an Enhanced World." J Law Med Ethics 36(1): 10-25.

 

 

6256-6448

* To subscribe, send an email to lists@case.edu with "subscribe thisweekincgreal <your-email-address>" in the message body. To unsubscribe, send an email to lists@case.edu with "unsubscribe thisweekincgreal <your-email-address>" in the message body.