Center NewsWelcome to Shawneequa Callier, CGREAL new post-doctoral fellow! Shawneequa received her M.A. in Bioethics from Monash University in Australia, and her J.D. from Georgetown University, and comes to us from two years of legal practice with interests in issues in genomic research with stored tissues and the commercialization of genomic research. Congratulations to CGREAL predoctoral trainee Shlomit Zuckerman on the successful defense of her doctoral dissertation, examining the expansion of Newborn Screening Program in Israel! Congratulations to Michelle McGowan, who has been awarded an F32 NIH Postdoctoral Fellowship with an outstanding priority score, but is foregoing that support as of July 1 to join the CWRU Department of Bioethics faculty ias an Assistant Professor of Bioethics. Welcome to George Anesi and ChiChi Ibegbu, CWRU medical students, who are now working with CGREAL on research projects! Congratulations to Robert Binstock, who has received the Ollie A. Randall Award from the National Council on the Aging for “singular and outstanding contributions toward advancing the cause of aging”! The next Best Practices meeting will be Monday, July 20, 2009 from 4:00-6:00 at the Cleveland Clinic Department of Bioethics. The next meeting will include a presentation by Kim Volarcik and a discussion on issues of consent and genome-wide association studies. Please contact Nicole Deming for more information. Aaron Goldenberg is one of the authors on a new article in Public Health Genomics titled "Not without my Permission: Parents' Willingness to Permit Use of Newborn Screening Samples for Research".
OpportunitiesRESEARCH FELLOWSHIPS IN BIOMEDICAL ETHICS The Research Institute of Law, Politics, and Justice invites expressions of interest from candidates who are suitable to apply to the Wellcome Trust Biomedical Ethics Programme for a Research Fellowship, or for a Biomedical Ethics Clinical Fellowship, based at Keele University. Call For AbstractsPHILOSOPHY OF MEDICINE ROUNDTABLE October 19-20, 2009
Conferences & Meetings
13th Genetics & Ethics in the 21st Century Conference:Genomics and Personalized Medicine: Facts, Fiction, Future? History of Genetics Conference Biobanking 2009 ASBH Annual Meeting The New Sentinels of Progress: Investigating Emerging Approaches to Governing Technology ResourcesCenters for Excellence in ELSI Research (CEER) Bibliographic database of audiovisuals, books, and articles, many of which are indexed using the Bioethics Thesaurus for Genetics.
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Genetics in the News
What can DNA tell us? Place your bets now In the spirit of famous scientific wagers by notable scientists, such as Stephen Hawking and Richard Feynman, two leading biologists, Professor Lewis Wolpert and Dr Rupert Sheldrake, have set up a wager on the predictive value of the genome.
Technology Review: Blogs: TR Editors' blog: A Renowned Geneticist Analyzes Consumer Tests "Francis Collins shares his thoughts on the present and future of consumer genetic medicine. ..."
'Gangsta gene' identified in US teens - New Scientist "It's not nearly as overt as a hand sign or a coloured bandana, but DNA may offer one clue as to whether someone belongs to a gang or not. ..."
Genetic Alliance Asks FDA for Public Genetic Test Registry | GenomeWeb Daily News | GenomeWeb "At a public meeting held by the US Food and Drug Administration in Washington, DC, today focused on ways to create more transparency in agency affairs, the advocacy group Genetic Alliance advised the FDA to host a registry for genetic tests and lab tests, and that it share all of its warning letters with the public. ..."
Research Revolution - 23andMe "23andMe launched a new initiative, Research Revolution, that seeks to cast the net much more widely in recruiting customers with specific diseases. Diseases that gets the required number of patients (currently 1,000) will be the subject of an association study performed by the company's scientists, using the genetic data from the assembled patients and controls. ..."
Privacy Groups Challenge Calif. Bill Pushing Regulatory Exemptions for 'Post-CLIA Bioinformatics Services' | GenomeWeb"California bill SB 482, sponsored by personal genomics company 23andMe, seeks "to distinguish so-called "post-CLIA bioinformatics services" from entities providing laboratory services" - have companies purely providing analysis of genetic data regulated separately from those doing the actual laboratory testing. ..."
Find Your Haplogroup "Ancestry.com DNA offers a Y-DNA and mtDNA haplogroup predictor - the Ancient Ancestry Finder - based primarily on location of your most distant known paternal or maternal ancestor. ..."
Chromosomal problems affect nearly all human embryos "Discovery may explain low fertility rates in humans ..."
Navigenics adds new health conditions to genetic testing panel "Navigenics has made some significant additions to our genetic testing services. Five new health conditions have been included in our test panel, and we have added 53 SNPs for a dozen existing conditions, which enhances the predictive ability of our genetic tests. We have also made improvements to our Alzheimer’s disease test. ..."
Genomics Law Report "News and analysis from the intersection of genomics, personalized medicine and the law ..."
TruGenetics, Inc. Enhancing Life Through Genomics "TruGenetics is a genomics company offering at least 10,000 free SNP scans to those who register at their website. Unlike most other personal genomics companies, TruGenetics users complete a survey to create a “personalized risk assessment survey.” ..."
Institutions, Company Spar Over Rights to RNAi : ScienceInsider "A fight has broken out over who owns important pieces of RNA interference (RNAi) technology, a strategy to silence genes that could prove extremely lucrative as companies figure out how to apply it to human disease. ..."
Navigenics CEO Reacts to Test Results "It was late Friday night – the email arrived to let me know that my Navigenics genetic test results were ready. ..."
Human genetics: One gene, twenty years : Nature News "When the cystic fibrosis gene was found in 1989, therapy seemed around the corner. Two decades on, biologists still have a long way to go ..."
Technology Review: Off-the-Shelf Genetic Testing On Display "The emerging market of direct-to-consumer genetic testing gets down to business. ..."
It’s Not Just the Sun: deCODE Discovers Sequence Variants Affecting Susceptibility to Skin Cancer | deCODE You "Scientists at deCODE genetics and academic colleagues from Europe and the United States today present in the journal Nature Genetics the discovery of common genetic risk factors for basal cell carcinoma (BCC) that affect people with fair and dark complexions alike. ..."
NIH RePORTER – NIH Research Portfolio Online Reporting Tool Expenditures and Results "NIH unveiled a beta version of RePORTER, a new database that will replace its well-known CRISP database in September. ..."
DNA could illuminate Islam’s lineage - The National Newspaper "For almost 1,600 years, the title Sharif, Sayyed, or Habib has been bestowed on Muslims who have been able to trace their roots back to the Prophet Mohammed through intricate family trees, oral histories and genealogical records. But now an American DNA lab says it may have identified the DNA signature of descendants of the Prophet Mohammed, and perhaps the prospect of a direct, more accurate means of confirming or identifying such a connection. ..."
CGS : Consumer genetics: Coming of age? "The emerging consumer genetics industry held its first convention-style show last week in Boston. We've been hearing much ado about this field for two years. This may be a sign that - for better or worse - the fledgling industry is coming of age. ..."
Updates and Improvements in deCODEme with new conditions and features | deCODE You "The deCODEme team has been busy working to update and improve your deCODEme experience. Additions include ABO blood types, Kidney stones, Eye color and Statin-induced myopathy. We have also added a section for feedback and research and a more detailed Male line analysis. ..."
Personal Genomics on Charlie Rose » The Genetic Genealogist "A recent episode of Charlie Rose regarding personal genomics. The show includes prominent members of the field, including George Church, Linda Avey, Anne Wojcicki, and Steven Pinker, among others. ..."
In pursuit of a happiness gene "The pursuit of happiness characterizes the human condition. But for those suffering from stress, money trouble or chronic illness, a positive outlook on life can be difficult to find. Now, a Tel Aviv University researcher says we should look to our genes. ..."
Return of the race myth? - New Scientist "But a funny thing happened on the way to the funeral. Shortly after the HGP's finding, several research projects began focusing on mapping this less than 1 per cent of human genetic variation onto social categories of race. ..."
Race origins and health disparites "Efforts to simplify the complexities of race— including genetic, cultural and socioeconomic variations—have made race-related research "a minefield of often premature and ultimately wrong conclusions," she said. ..."
Bioethicists lead call for public debates on future uses of stem cells "Science is running ahead of public debate and guidelines to grapple with use of stem cell-derived eggs and sperm ..."
Can DNA tests help your genealogical inquiries? | CITIZEN-TIMES.com | Asheville Citizen-Times "With the famous Thomas Jefferson-Sally Hemmings case, folks began to realize that DNA testing techniques could give answers and break down brick walls as never before. ..."
IVF discounts beat cash rewards for research eggs - New Scientist "YOU can't get something for nothing, especially when it comes to acquiring women's eggs for medical research. But it is becoming clear that there are effective alternatives to cash payments, which are banned in several countries. ..."
The Human Genre Project "The Human Genre Project is a collection of new writing in very short forms — short stories, flash fictions, reflections, poems — inspired by genes and genomics. Some pieces, though not all, relate to a specific gene. ..."
Genetics in the Literature
(2009). "Designing rules for designer babies." Sci Am. 300(5): 29.
"This paper discusses the pros and cons of introducing PGD for mitochondrial DNA (mtDNA) disorders such as NARP (Neurogenic muscle weakness, Ataxia, Retinis Pigmentosa)/Leigh, MELAS (Mitochondrial myopathy, Encephalopatyhy, Lactic acidoysis, and Stroke-like episodes), private mtDNA mutations and LHON (Leber Hereditary Optic Neuropathy). Although there is little experience with PGD for mtDNA disorders, it is reasonable to assume that in many cases, the best one can achieve is the selection of the least' affected embryos for transfer. So instead of promising' parents a healthy child, PGD in these cases can only aim at reducing reproductive risk. From an ethical point of view, this raises challenging questions about parental and medical responsibilities. The main argument in favour of PGD is that it offers couples at risk the opportunity of reducing their chances of having a severely affected child. Potential objections are manifold, but we conclude that none of them supplies convincing moral arguments to regard risk-reducing PGD as unacceptable. Nevertheless, introducing this new application of PGD in clinical practice will raise further complex issues of determining conditions for its responsible use. ..."
Briggs, L. and J. I. Kelber-Kaye (2000). ""There is no unauthorized breeding in Jurassic Park": gender and the uses of genetics." Nwsa J. 12(3): 92-113.
"Although investigators using methodologies in bioinformatics have always been useful in genomic experimentation in analytic, engineering, and infrastructure support roles, only recently have bioinformaticians been able to have a primary scientific role in asking and answering questions on human health and disease. Here, I argue that this shift in role towards asking questions in medicine is now the next step needed for the field of bioinformatics. I outline four reasons why bioinformaticians are newly enabled to drive the questions in primary medical discovery: public availability of data, intersection of data across experiments, commoditization of methods, and streamlined validation. I also list four recommendations for bioinformaticians wishing to get more involved in translational research. ..."
Campbell, J., J. A. Schermer, et al. (2009). "A behavioral genetic study of the dark triad of personality and moral development." Twin Res Hum Genet. 12(2): 132-6.
"The present study is the first behavioral genetic investigation of relationships between the Dark Triad of personality--Machiavellianism, narcissism, and subclinical psychopathy--and moral development. Participants were 154 monozygotic twin pairs and 82 same-sex dizygotic twin pairs. Higher scores on Machiavellianism and psychopathy were positively correlated with low levels of moral development; high psychopathy scores also correlated negatively with high levels of moral development. Individual differences in lower levels of moral development were attributable to genetic and nonshared environmental factors but, very interestingly, individual differences in the highest levels of moral development showed no genetic basis but were entirely attributable to shared and nonshared environmental factors. Finally, correlations between the Dark Triad and moral development variables showed no genetic basis while correlations among the moral development variables were variously attributable to correlated genetic and correlated environmental factors. ..."
"The field of cancer genetics is evolving rapidly, and much has changed over the past ten years in the way services are being provided and by whom they are being provided. We recount here our experience with the evolution of cancer genetic services in a community setting, focusing on collaboration with non-genetics providers to offer genetic testing for hereditary cancer. This approach allows for the most effective use of genetic counselors’ expertise for challenging cases, and enables the patient to remain within their community to allow for better access to resources for long-term follow-up. ..."
"On the 20th anniversary of the identification of the cystic fibrosis gene, as new gene discoveries pile up weekly and hype over the power of genes to transform medicine flows fast, CF offers an object lesson in how difficult it is, and how long it takes, to convert genetic knowledge into treatments. Every CF expert agrees that the gene discovery transformed their understanding of the disease's pathology. But even after so much hard work, not a single therapy based on the CF gene has reached the market. Some promising treatments, especially gene therapy, have proven bitterly disappointing. ..."
"The article discusses the Prenatally and Postnatally Diagnosed Awareness Act which was cosponsored by Kansas Republican Senator Sam Brownback and Massachusetts Democratic Senator Edward Kennedy in the U.S. The law, which aims to improve the quality of information about children with disabilities, covers the Down syndrome and any health condition diagnosed during the prenatal period or up to one year after a child's birth. It also allows the U.S. Secretary of Health and Human Services to provide grants and collaborate with states and expert groups including disability organizations. It is noted that the senators view women's choices about pregnancy through the standard informed consent framework. ..."
"The emerging "diabetes epidemic" threatens to affect 366 million people worldwide by 2030. In the UK, almost 2 million people (about 3.9 percent of the population) are currently diagnosed with diabetes and it is estimated that a further 1 million people have the disease but do not realize it. The prevalence of diabetes, its complications and their effects on the lives of those living with diabetes mean that diabetes research has the potential to bring significant benefits. In this paper, we are concerned with the research involving human embryonic stem (HES) cells that sees diabetes as a potential therapeutic location. Drawing on the idea of the "certainty trough" we examine how the hopes and uncertainties associated with this complex research agenda are understood. We show that those at the research front and those most opposed to the research agenda appear to be the most aware of the uncertainties that need to be resolved. In contrast, funders, typically one-step removed from the research work, see the promise of the research as more real and more likely to be achieved. Significantly, these optimistic funders are supported in their beliefs by the research scientists as constitutive claims are reproduced within the contingent forum. The effect is a collaborative project in which the promise of a technical solution "just around the corner" is sustained whilst concerns about the future difficulties are marginalized. ..."
"BACKGROUNDMutations in breast cancer BRCA1/2 genes increase breast and ovarian cancer risk and are transmitted with an autosomal dominant pattern. Opinion about reproductive decisions among individuals undergoing BRCA1/2 testing in our institutions is unknown. MATERIALS AND METHODSIndividuals (n = 77) undergoing BRCA1/2 testing were included in a prospective multicentre study to assess the clinical impact of genetic testing. Demographic and clinical information, psychological status and opinion about reproductive decisions were collected in two questionnaires administered prior to testing. Opinion regarding the use of assisted reproduction techniques for hereditary cancer susceptibility among health care professionals was also collected. RESULTSTwenty-eight individuals (36%) reported that they would decide to have children, regardless of their result. In case of a mutation, 9 (12%) believed that they would decide not to have children, 42 (55%) would consider prenatal diagnosis (PND), 37 (48%) would consider preimplantation genetic diagnosis (PGD) and 23 (30%) would consider adoption. Fifty-seven (74%) and 47 (61%) reported that they considered it ethical to offer PND or PGD, respectively, to BRCA+ patients. Individuals older than 40 years were more likely to consider PND or PGD than younger subjects (P = 0.02 and 0.05, respectively). Individuals with cancer compared with those without a diagnosis of malignancy were more likely to consider PGD (61 versus 30%, P = 0.02) and to consider that it was ethical to offer it (74 versus 44%, P = 0.02). Most health care professionals were in favour of PND and PGD for individuals with hereditary cancer susceptibility (58 and 61%, respectively). CONCLUSIONSBRCA1/2 genetic results could influence an individual's decisions regarding reproduction. Health care professionals who serve individuals undergoing BRCA testing should incorporate patient education regarding the potential impact of such testing on family planning. ..."
"Making use of a comparative perspective on the emergence of breast cancer genetic in the different cultural context of the UK and Cuba, this article examines the tensions between the modern promise of genomics as personalised medicine and a commitment to public health. Focusing primarily on the Cuba context and drawing on ethnographic research as part of a collaborative project working with genetic professionals and publics, the article examines the particular technologies, identities and socialities at stake in an emerging and evolving field of genetic medicine. It highlights how long-standing continuities in the commitment to the equitable provision of public health, particularly as this relates to ‘family medicine’, are central to understanding the scope and expansion of ‘community genetics’ interventions, even when at the level of local practice, public health is also now subject to the unequal dynamics of economic necessity through the working out of ‘lo informal’. Illuminating the different ways agency, risk, responsibility, citizenship and activism get configured by and between publics and health professionals in Cuba, the article reveals the challenges and opportunities posed by predictive genomic medicine in relation to the dynamic and shifting terrain of public health. ..."
Grosse, S. D., W. H. Rogowski, et al. (2009). "Population Screening for Genetic Disorders in the 21st Century: Evidence, Economics, and Ethics." Public Health Genomics 29: 29.
"Background: Proposals for population screening for genetic diseases require careful scrutiny by decision makers because of the potential for harms and the need to demonstrate benefits commensurate with the opportunity cost of resources expended. Methods: We review current evidence-based processes used in the United States, the United Kingdom, and the Netherlands to assess genetic screening programs, including newborn screening programs, carrier screening, and organized cascade testing of relatives of patients with genetic syndromes. In particular, we address critical evidentiary, economic, and ethical issues that arise in the appraisal of screening tests offered to the population. Specific case studies include newborn screening for congenital adrenal hyperplasia and cystic fibrosis and adult screening for hereditary hemochromatosis. Results: Organizations and countries often reach different conclusions about the suitability of screening tests for implementation on a population basis. Deciding when and how to introduce pilot screening programs is challenging. In certain cases, e.g., hereditary hemochromatosis, a consensus does not support general screening although cascade screening may be cost-effective. Conclusion: Genetic screening policies have often been determined by technological capability, advocacy, and medical opinion rather than through a rigorous evidence-based review process. Decision making should take into account principles of ethics and opportunity costs. ..."
"Ethical regulation of social research has increased considerably in the UK in the past few years, not least as a result of the ESRC's Research Ethics Framework. This article questions whether ethics committees are capable of making sound judgments about the ethics of what is proposed and practised in particular research projects. In addition, the legitimacy of such regulation is questioned, on ethical grounds. Finally, it is argued that increased regulation will not raise the 'ethical standard' of social science and will probably worsen the quality of what it produces. ..."
"While the number of genetic tests continues to grow, publicly accessible information about the analytic and clinical validity of such tests is lagging. Information gaps impede informed decision making by health care providers and patients. Enhancing the transparency of information about what tests are being offered, for which indications tests are being offered, and the analytic and clinical validity of tests is a key prerequisite to ensuring test quality. A recent government recommendation for a mandatory genetic test registry has received wide stakeholder support but leaves many practical questions unanswered. We propose a 'blueprint' for the creation of a genetic test registry in order to expedite its implementation. We describe the goals of a registry, propose criteria for the inclusion of registrants and tests in the registry, and define the categories of information that should be included for such tests. We discuss the sources of legal authority that empower the government to mandate that a registry be established and identify the federal agencies with the relevant expertise and resources to do so. We conclude that establishing a registry is a critical first step in the development of a more transparent, quality-centered system of oversight that will better inform and protect the public. ..."
"The Bioethics Council's Report Who Gets Born? elicited considerable public comment with its recommendation regarding the use of preimplantation genetic diagnosis (PGD) for sex selection for social reasons. The Report was based on a process of deliberative consultation, in which determined efforts had been expended to obtain the views of ordinary New Zealanders. Consequently, the manner in which the recommendations, including this particular one on sex selective PGD, were informed by the consultation is of considerable interest. We argue that the Council is unclear about the role that the views of the public should play in its activities. It appears to place great emphasis on involving the public in formulating policy conclusions through deliberative consultation, but some of its recommendations suggest that the views of the public have only been allowed to play a limited role in its reasoning. Unfortunately, the Council's report does not provide sufficient detail of the reasoning underlying these recommendations. We argue that the Council should have adopted a more transparent style of reporting, thereby enabling the public to understand both the scope of their influence on the Council and the reasoning behind the recommendations. This would have allowed the report to be more constructively critiqued, and the controversy attendant on the release of the report to be minimised. ..."
"Recent advances in sequencing technologies have initiated an era of personal genome sequences. To date, human genome sequences have been reported for individuals with ancestry in three distinct geographical regions: a Yoruba African, two individuals of northwest European origin, and a person from China1, 2, 3, 4. Here we provide a highly annotated, whole-genome sequence for a Korean individual, known as AK1. The genome of AK1 was determined by an exacting, combined approach that included whole-genome shotgun sequencing (27.8 coverage), targeted bacterial artificial chromosome sequencing, and high-resolution comparative genomic hybridization using custom microarrays featuring more than 24 million probes. Alignment to the NCBI reference, a composite of several ethnic clades5, 6, disclosed nearly 3.45 million single nucleotide polymorphisms (SNPs), including 10,162 non-synonymous SNPs, and 170,202 deletion or insertion polymorphisms (indels). SNP and indel densities were strongly correlated genome-wide. Applying very conservative criteria yielded highly reliable copy number variants for clinical considerations. Potential medical phenotypes were annotated for non-synonymous SNPs, coding domain indels, and structural variants. The integration of several human whole-genome sequences derived from several ethnic groups will assist in understanding genetic ancestry, migration patterns and population bottlenecks. ..."
"Genetic ancestry testing is being applied in areas as diverse as forensics, genealogical research, immigration control, and biomedical research. Use of ancestry as a potential risk factor for disease is entrenched in clinical decision-making, so it is not surprising that techniques to determine genetic ancestry are increasingly deployed to identify genetic variants associated with disease and drug response. Recently, direct-to-consumer (DTC) personal genomics companies have used ancestry information to calculate individual risk profiles for a range of diseases and traits. ..."
"Whole-genome research projects, especially those involving whole-genome sequencing, tend to raise intractable ethical and legal challenges. In this kind of research, genetic and genomic data obtained by typing or sequencing are usually put in open or limited access scientific databases on the Internet to promote studies by many researchers. Once data become available on the Internet, it will be virtually meaningless to withdraw the information, effectively nullifying participants' right to revoke consent. Although the author favors the governance system that will assure research subjects of the right to withdraw their participation, considering these characteristics of whole-genome research, he finds those recommendations offered in Caulfield T, et al: Research ethics recommendations for whole-genome research: Consensus statement. PLoS Biol 6(3): e73(2008), especially to the effect that the consent process should include information about data security and the governance structure and, in particular, the mechanism for considering future research protocols, well reasoned and acceptable. ..."
"Although Foucault adamantly refused to make moral pronouncements or dictate moral principles or political programs to his readers, his work offers a number of tools and concepts that can help us develop our own ethical views and practices. One of these tools is genealogical analysis, and one of these concepts is "biopower." Specifically, this essay seeks to demonstrate that Foucault's concept of biopower and his genealogical method are valuable as we consider moral questions raised by genetic enhancement technologies. First, it examines contemporary debate over the development, marketing, and application of such technologies, suggesting that what passes for ethical deliberation is often little more than political maneuvering in a field where stakes are very high and public perceptions will play a crucial role in decisions about which technologies will be funded or disallowed. It goes on to argue that genuine ethical deliberation on these issues requires some serious investigation of their historical context. Accordingly, then, it takes up the oft-heard charge from critics that genetic enhancement technologies are continuous with twentieth-century eugenic projects or will usher in a new age of eugenics. Foucault explicitly links twentieth-century eugenics with the rise of biopower. Through review of some aspects of the twentieth-century eugenics movement alongside some of the rhetoric and claims of enhancement's modern-day proponents, the essay shows ways in which deployment of genetic enhancement technologies is and is not continuous with earlier deployments of biopower. ..."
Meschia, J. F. and K. Gwinn (2009). "Genetics in clinical trials." Front Neurol Neurosci. 25: 152-7. Epub 2009 Mar 19.
Murray, T. H. (2009). Deciphering Genetics. Hastings Center Report, Hastings Center. 39: 19-22.
"An essay about the genetics project of The Hastings Center is presented. It discusses the Genetics Group formed by The Hastings Center to manage the Genetic Counseling and Engineering Program which was led by Marc Lappé. The two themes cited from the center's project involved the links between genes and human phenomena such as disease and intelligence and scientific apology which refers to the practice of using genetics as explanation for social inequalities or questions like why workers are getting sick or injured. ..."
"Over the last three to four years, an increasing number of private and public sector tertiary level hospitals and research centres in India have been using stem cell therapy, especially adult stem cell therapy, in the guise of experimental therapy for a variety of medical conditions. The promotion and growth of this experimental field across local and national borders traverses regulatory, ethical, social and financial boundaries. In this complex context, the article examines how healthcare centres in India negotiate bio-medical and health care circumstances in promoting a therapy that raises questionable medical, technical and ethical issues. The process of promoting experimental stem cell therapy is explained here by employing the concept of bionetworking and illustrated by two case studies of hospital groups. The case studies show how through bionetworking a centre creates and maintains novel networks of mutual exchanges with other collaborative bodies situated in local, national and global relations of inequality. Drawing on a three-month period of fieldwork and interviews in various locations in India, this article shows that: (1) Questionable stem cell therapy is promoted through bionetworks that resonate across local, national and global constellations; (2) Regulatory gaps facilitate the growth of such therapeutic practices; (3) The experimental stem cell therapies augment the healthcare divide in Indian society; (4) The weakening Indian state facilitates commercialisation of health, indirectly supporting the ‘bionetworking’ practices of therapy providers. ..."
Rennie, S. (2009). "The FDA and Helsinki." Hastings Center Report 39(3): 49-49.
"In this article the author comments on the need for the Obama administration to adopt research ethics regulations that consider the interests of research participants and communities. He questions the motivation behind the U.S. Food and Drug Administration's decision to adopt Good Clinical Practice (GCP) regulations, as well as the ethical significance of this decision. He notes the possibility of confusion as researchers try to adhere to a changing document. He says the argument that GCP adoption will lead to less confusion is debatable. ..."
"Research in genetics and genomics has led to an expanding list of molecular genetic tests, which are increasingly entering health care systems. However, the evidence surrounding the benefits and harms of these tests is frequently weak. Here we present the main challenges to the successful translation of new research findings about genotype–phenotype associations into clinical practice. We discuss the means to achieve an accelerated translation research agenda that is conducted in a reasonable, fair and efficient manner. ..."
Rothstein, M. A., Y. Cai, et al. (2009). "The ghost in our genes: legal and ethical implications of epigenetics." Health Matrix Clevel. 19(1): 1-62.
"Epigenetics is one of the most scientifically important, and legally and ethically significant, cutting-edge subjects of scientific discovery. Epigenetics link environmental and genetic influences on the traits and characteristics of an individual, and new discoveries reveal that a large range of environmental, dietary, behavioral, and medical experiences can significantly affect the future development and health of an individual and their offspring. This article describes and analyzes the ethical and legal implications of these new scientific findings. ..."
Rudan, I., A. Marusic, et al. (2009). ""10001 Dalmatians:" Croatia launches its national biobank." Croat Med J. 50(1): 4-6.
"The sharing of genetic information following the diagnosis of a genetic condition can be important for managing familial risks for genetic conditions. This paper explores factors that impede or facilitate the sharing of genetic information within a sample of British Pakistani families. It draws from research investigating understandings of genetics and inheritance, attitudes to prenatal diagnosis and risk communication in the family that used methods of participant observation and interview with adults from 66 families of Pakistani origin referred to a genetics clinic in southern England. We found a lack of English often restricted one partner's access to genetic information and partners fluent in English sometimes withheld information to protect a partner (usually the wife) from blame, stigma or feelings of marital insecurity. Many couples felt genetic information was private to them as a couple and were unwilling to share it with the wider family, commenting on its potentially stigmatizing and emotionally and socially disruptive effects on themselves, their child and their marriage, as well as on the marriage prospects of other family members. Those who sought carrier testing because of a family history did so when considering their own marriage or parenting, sometimes on the insistence of an affected relative, but did not readily discuss carrier testing with other relatives. Despite the complex consanguinity in some families, a family-based approach to risk management is not necessarily any easier among British Pakistanis than other ethnic groups. ..."
"According to the thrifty genotype hypothesis, the high prevalence of type 2 diabetes and obesity is a consequence of genetic variants that have undergone positive selection during historical periods of erratic food supply. The recent expansion in the number of validated type 2 diabetes- and obesity-susceptibility loci, coupled with access to empirical data, enables us to look for evidence in support (or otherwise) of the thrifty genotype hypothesis using proven loci. We employed a range of tests to obtain complementary views of the evidence for selection. Our results provide some evidence for selection at specific loci, but there are no consistent patterns of selection that provide conclusive confirmation of the thrifty genotype hypothesis. Discovery of more signals and more causal variants for type 2 diabetes and obesity is likely to allow more detailed examination of these issues. ..."
Sparrow, R. (2009). "Therapeutic Cloning and Reproductive Liberty." J Med Philos 34(2): 102-118.
"Concern for "reproductive liberty" suggests that decisions about embryos should normally be made by the persons who would be the genetic parents of the child that would be brought into existence if the embryo were brought to term. Therapeutic cloning would involve creating and destroying an embryo, which, if brought to term, would be the offspring of the genetic parents of the person undergoing therapy. I argue that central arguments in debates about parenthood and genetics therefore suggest that therapeutic cloning would be prima facie unethical unless it occurred with the consent of the parents of the person being cloned. Alternatively, if therapeutic cloning is thought to be legitimate, this undermines the case for some uses of reproductive cloning by implying that the genetic relation it establishes between clones and DNA donors does not carry the same moral weight as it does in cases of normal reproduction. ..."
"Negative consumer opinion poses a potential barrier to the application of nutrigenomic intervention. The present study has aimed to determine attitudes toward genetic testing and personalised nutrition among the European public. An omnibus opinion survey of a representative sample aged 14%) reported that they would be willing to undergo genetic testing and 27 % to follow a personalised diet. Individuals who indicated a willingness to have a genetic test for the personalising of their diets were more likely to report a history of high blood cholesterol levels, central obesity and/or high levels of stress than those who would have a test only for general interest. Those who indicated that they would not have a genetic test were more likely to be male and less likely to report having central obesity. Individuals with a history of high blood cholesterol were less likely than those who did not to worry if intervention foods contained GM ingredients. Individuals who were aware that they had health problems associated with the metabolic syndrome appeared particularly favourable toward nutrigenomic intervention. These findings are encouraging for the future application of personalised nutrition provided that policies are put in place to address public concern about how genetic information is used and held. ..."
"The last few years have seen major advances in common non-syndromic obesity research, much of it the result of genetic studies. This Review outlines the competing hypotheses about the mechanisms underlying the genetic and physiological basis of obesity, and then examines the recent explosion of genetic association studies that have yielded insights into obesity, both at the candidate gene level and the genome-wide level. With obesity genetics now entering the post-genome-wide association scan era, the obvious question is how to improve the results obtained so far using single nucleotide polymorphism markers and how to move successfully into the other areas of genomic variation that may be associated with common obesity. ..."
Wideroff, L., K. A. Phillips, et al. (2009). "A health services research agenda for cellular, molecular and genomic technologies in cancer care." Public Health Genomics. 12(4): 233-44. Epub 2009 Feb 20.
"In recent decades, extensive resources have been invested to develop cellular, molecular and genomic technologies with clinical applications that span the continuum of cancer care. METHODS: In December 2006, the National Cancer Institute sponsored the first workshop to uniquely examine the state of health services research on cancer-related cellular, molecular and genomic technologies and identify challenges and priorities for expanding the evidence base on their effectiveness in routine care. RESULTS: This article summarizes the workshop outcomes, which included development of a comprehensive research agenda that incorporates health and safety endpoints, utilization patterns, patient and provider preferences, quality of care and access, disparities, economics and decision modeling, trends in cancer outcomes, and health-related quality of life among target populations. CONCLUSIONS: Ultimately, the successful adoption of useful technologies will depend on understanding and influencing the patient, provider, health care system and societal factors that contribute to their uptake and effectiveness in 'real-world' settings. ..."
"Yet, some legislators and scientists worry that do-it-yourself (DIY) biology might pose a danger to public health and environmental safety, and that unregulated experiments conducted in kitchens and garages might accidentally or intentionally unleash biological disaster. ..."
Zukerman, W. (2009). "Genetic discrimination in the workplace: towards legal certainty in uncertain times." J Law Med. 16(5): 770-88.
"Scientists can analyse DNA to reveal our likelihood of developing certain diseases. As technology advances, it raises questions as to how much emphasis should be placed on genetic testing in the workplace. In 2008 the United States implemented the Genetic Information Nondiscrimination Act, prohibiting employers from using a person's genetic information in the workplace. This article discusses how Australia should act to prevent unjustified genetic discrimination in the workplace. In 2003 a report from the Australian Law Reform Commission and the Australian Health Ethics Committee, entitled Essentially Yours, concluded it was important to legislate now to protect employees from unlawful discrimination rather than wait for the technology to advance. This article assesses and adds to the recommendations of this report. It argues that genetic status should be considered an inherent requirement of a job, and therefore genetic discrimination should be lawful where it may protect employees themselves, third parties at risk and in professions where it is necessary that employees be healthy in the future. However, to avoid unjustified discrimination, genetic information should only be lawfully used in the workplace where there is a very high probability that the disease will manifest within a specified number of years. ..."
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