The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because these findings may be beneficial (...) to patients and their families. Communicating individual BRCA results was not anticipated during clinical trial design. Consequently, options were not available for patients to indicate their preference for receiving their individual results when they signed pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study provided clinical investigators with a mechanism to disseminate the overall study finding to patients while taking individual circumstances, local guidelines and clinical practice into account. This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results. This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees. (shrink)

Persons exhibiting mutations in two tumor suppressor genes, BRCA1 and BRCA2, have a greatly increased risk of developing breast and/or ovarian cancer. The incidence of BRCA gene mutation is very high in Ashkenazi Jewish women of European descent, and many issues can arise, particularly for observant Orthodox women, because of their genetic status. Their obligations under the Jewish code of ethics, referred to as Jewish law, with respect to the acceptability of various risk-reducing strategies, may be poorly understood. In (...) this article the moral direction that Jewish law gives to women regarding testing, confidentiality, and other issues is explored. The intent is to broaden nurses' knowledge of how a particular religious tradition could impact on decision making around genetics testing, with the aim of enhancing their understanding of culturally sensitive ethical care. (shrink)

: Decisions about funding health services are crucial to controlling costs in health care insurance plans, yet they encounter serious challenges from intellectual property protection—e.g., patents—of health care services. Using Myriad Genetics' commercial genetic susceptibility test for hereditary breast cancer (BRCA testing) in the context of the Canadian health insurance system as a case study, this paper applies concepts from social contract theory to help develop more just and rational approaches to health care decision making. Specifically, Daniels's and Sabin's (...) "accountability for reasonableness" is compared to broader notions of public consultation, demonstrating that expert assessments in specific decisions must be transparent and accountable and supplemented by public consultation. (shrink)

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs for new (...) health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. ;In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns---about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship". (shrink)

Myriad Genetics holds a patent on testing for the hereditary breast and ovarian cancer genes, BRCA1 and BRCA2, and therefore has a forced monopoly on this critical genetic test. Myriad launched a Direct-to-Consumer (DTC) marketing campaign in the Northeast United States in September 2007 and plans to expand that campaign to Florida and Texas in 2008. The ethics of Myriad's patent, forced monopoly and DTC campaign will be reviewed, as well as the impact of this situation on patient access and (...) care, physician liability, and the future of DTC campaigns for genetic testing. (shrink)

In this paper we explore the rise of ‘the breast cancer gene’ as a field of medical, cultural and personal knowledge. We address its significance in the Norwegian public health care system in relation to so-called biological citizenship in this particular national context. One of our main findings is that, despite its claims as a measure for health and disease prevention, gaining access to medical knowledge of BRCA 1/2 breast cancer gene mutations can also produce severe instability in the (...) individuals and families affected. That is, although gene testing provides modern subjects with an opportunity to foresee their biological destiny and thereby become patients in waiting, it undoubtedly also comes with difficult existential dilemmas and choices, with implications that resonate beyond the individual and into different family and love relations. By elaborating on this finding we address the question of whether the empowerment slogan, which continues to be advocated through various health, BRCA and breast cancer discourses, reinforces a naïve or an idealized notion of the actively responsible patient: resourceful enough to seek out medical expertise and gain sufficient knowledge, on which to base informed decisions, thereby reducing the future risk of developing disease. In contrast to this ideal, our Norwegian informants tell a different story, in which there is no apparent heroic mastery of genetic fates, but rather a pragmatic attitude to dealing with a dire situation over which they have little control, despite having complied with medical advice through national guidelines and follow-up procedures for BRCA 1/2 carriers. In conclusion we claim that the sense of safety that gene testing and its associated medical solutions allegedly promise to provide proved illusory. Although BRCA-testing offers the potential for protection from adverse DNA-heritage, administered through possibilities for self-monitoring and self-management of the body, the feeling of ‘being in good health’ has hardly been reinforced by the emergence of gene technology. (shrink)

Iniaalok ng pag-aaral na ito ang isang panunuring Foucauldian sa pangkasariang karanasan ng babaeng may breast cancer (BRCA). Inihahain din ng mga may-akda ang mga sumusunod na tanong: Paano naaapi ang babaeng may BRCA? Paano hinahamon ng kanyang karanasan ang konsepto ng seksuwalidad? Maaari bang ituring ang kanyang karanasan bilang anyo ng pagbalikwas? Tutugunan ng mga may-akda ang naturang mga tanong gamit ang kapangyarihan-diskurso-seksuwalidad ni Foucault habang ipinapalagay na: (1) matagumpay na naipapakita ng talaangkanan ng seksuwalidad ni Foucault (...) kung paanong ang seksuwalidad, bilang isang diskursibong kontrak, ay ginagamit bilang isang teknik ng pangongontrol, at (2) nabibigyan tayo ni Foucault ng isang paraan ng pag-unawa sa kung papaano tumutugon ang indibidwal sa iba’t ibang sistema ng kontrol, maging ng isang balangkas na makapagpapaliwanag sa maraming relasyong pangkapangyarihan na siyang tumutukoy sa moda ng pag-iral ng indibidwal. Nahahati ang papel na ito sa tatlong pangunahing bahagi: (1) Ang Panunuring Feminista ng Sabjek na Foucauldian, (2) Ang Pangkasariang Karanasan ng Babaeng may BRCA, at (3) Pagbalikwas bilang Diskurso-Konstrak at Binuong Tugon. (shrink)

As genetic testing for the presence of potentially health-affecting mutations becomes available for more genetic conditions, many people will soon be faced with the decision of whether or not to have a genetic test. Making an informed decision requires an understanding and evaluation of the arguments for and against having the test. As a case in point, this paper considers argumentation involving the decision of whether to have a BRCA gene test, one of the first commercially available genetic tests. (...) First, argumentation in a five-page patient brochure from a for-profit company that provides BRCA gene testing, is analyzed. Next, for comparison, argumentation on BRCA testing in materials for healthcare consumers written by a not-for-profit health plan and a government organization, is analyzed. In view of the challenges identified by considering these examples, this article discusses how argumentation-oriented computer systems may be able to help the healthcare consumer to make informed decisions about genetic testing. (shrink)

This paper, using modern Darwinian theory, proposes an explanation for the increasingly high incidence of breast cancer found among pre-and post-menopausal women living today in westernized countries. A number of factors have been said to be responsible: genetic inheritance (BRCA-1), diet (specifically the increased consumption of dietary fat), exposure to carcinogenic agents, lifetime menstrual activity, and reproductive factors. The primary aim of this paper is to demonstrate the value of a perspective based on Darwinian theory. In this paper, Darwinian (...) theory is used to explore the possibility that the increased incidence of breast cancer is due primarily to the failure to complete in a timely manner the reproductive developmental cycle, beginning at menarche and continuing through a series of pregnancies and lactation. On the basis of comparative data, we assume that most women in ancestral populations began having children before age 20 or so and tended to remain either pregnant or nursing for most of their adult lives. If a woman did not have a child by age 25 or so, she probably would never have one. Therefore, selection would probably not have acted against deleterious traits, such as cancer, that appeared after that age, just as it does not act against such traits in old age. (shrink)

This is a response to a short communication on our research presented in Solbrække et al. (Med Health Care Philos 20(1):89–103, 2017), which raises a series of serious allegations. Our article explored the rise of ‘the breast cancer gene’ as a field of medical, cultural and personal knowledge. We used the concept biological citizenship to elucidate representations of, and experiences with, hereditary breast cancer in a Norwegian context, addressing a research deficit. In our response to Møller and Hovig’s (Med Health (...) Care Philos 21(2):239–242, 2018a) opinionated piece, we start by questioning on which scientific grounds they base their knowledge claims and situate their criticism in a pre-determined positivist script, which exposes their incompetency when it comes to establishing a useful critique of our research. We tie this to an attitude of scientific supremacy, which reduces the complexity and specificity of different knowledges into a clichéd divide between ‘hard evidence’ and ‘fiction’—presented in a predictable narrative which seeks to establish research protagonists and antagonists. We elaborate on the rationale of our qualitative approach to analyzing and interpreting situated and mediated aspects of BRCA 1/2. We counter claims that our research does harm to patients. We refer to a medical scandal emerging from Norway where 21 women were wrongfully diagnosed and surgically treated for a mis-interpreted cancer gene mutation. In conclusion, we stand by the integrity of our research as reported in the original paper. Scientific supremacy and pre-scripted criticism impose considerable obstacles for the possibility of establishing interdisciplinary dialogue across knowledge paradigms in health care and medicine. We therefore urge readers to reflect on how we can establish and sustain ethically careful and truthful dialogue—without doing violence to epistemological differences—to protect and advance the interdisciplinarity that constitutes the journal’s scope. (shrink)

Gene patenting has captured the headlines for the past four years, thanks in large part to the lawsuit the American Civil Liberties Union and the Public Patent Foundation brought against Myriad Genetics for the patents on the breast cancer genes, BRCA 1 and 2. Despite their recent celebrity, human gene patents have been granted by the United States Patent and Trademark Office for over thirty years. The commodification of the human body is not all that recent: one might be (...) tempted to argue that gene patenting is the inevitable next step in the com-modification of natural processes and products. Edward Yoxen dates the origins of the technological capitalization of life back to the 1920s.. (shrink)

Perhaps no other medical advocacy movement has been as successful as breast cancer advocacy in increasing awareness and funds. Recent decades have seen a division between a “green” environmental advocacy aimed at prevention and a “pink” advocacy focused on fund-raising for a cure. The movement has largely failed to address the implications of corporate control over genetic testing, as reflected by the involvement of only one breast cancer organization in the lawsuit against Myriad Genetics Laboratory, which held patents on the (...) BRCA 1/2 genes. This article argues that the reason for this failure is an unwillingness to challenge the role that corporations play in advocacy. (shrink)