This paper provides a marketing ethics analysis that addresses the practice of selling genetic tests directly to the consumer. It details the complexity of this emergent sector by articulating the panoply of evolving ethical/social questions raised by this development. It advances the conversation about DTC genetic testing by reviewing the business and healthcare literature concerning this topic and by laying out the inherent ethical complications for consumers, marketers, and regulators. It also points to several possible public (...) and company policy adjustments. Because this area is relatively new and incredibly dynamic, its current discussion is necessarily an exercise in the “logic of discovery” rather than the “protocol of validation”. The paper serves as a primer for the types of GT being promoted. It also calls for a public discourse in the academic and general community to uncover and define the ethical guidelines and systemic adjustments necessary to create fairness in the various DTC transactions occurring between genetic test sellers and the buyers/clients of their services. (shrink)

In Vayena’s article, ‘direct-to-consumer (DTC) genomics on the scales of autonomy’, she claims that there may be a strong autonomy-based argument for permitting DTC genomic services. In this response, I point out how the diminishment of one’s genetic privacy can cause a relevant autonomy-related harm which must be balanced against the autonomy-related gains DTC services provide. By drawing on conceptual connections between privacy and the Razian conception of autonomy, I show that DTC genetic testing may (...) decrease the range of valuable options individuals possess, which impacts the extent to which would-be consumers can exercise their autonomy. (shrink)

Direct-to-consumer genetic testing has been available for several years now, with varying degrees of regulation across different countries. Despite a restrictive legal framework it is possible for consumers to order genetic tests from companies located in other countries. However, German laypeople’s awareness and perceptions of DTC GT services is still unexplored. We conducted seven focus groups with German laypeople to explore their perceptions of and attitudes towards commercial genetic testing and its ethical implications. (...) Participants were critical towards DTC GT. Criticism was directed at health-related, predictive testing, while lifestyle tests were accepted and even welcomed to some extent. Participants expressed strong reservations regarding commercial provision of genetic diagnostics and expressed a lack of trust in respective companies. They preferred non-commercial distribution within the public healthcare system. Participants also expressed high expectations of physicians’ abilities to interpret information obtained via DTC GT companies and provide counseling. Legal restrictions on commercial distribution of genetic tests were opposed, with participants arguing that it should be available to consumers. DTC GT companies are not perceived as trustworthy when compared to the public healthcare system and its professional ethical standards and practices. Laypeople rated general consumer autonomy higher than their own concerns, thus recommending against strong legal regulation. We conclude that medicine’s trustworthiness may be negatively affected if commercial provision is not visibly opposed by the medical professions, while DTC GT companies may gain in trustworthiness if they adapt to standards and practices upheld in medicine. (shrink)

In this paper, I provide an epistemic evaluation of the harms that result from the widespread marketing of direct-to-consumer (DTC) genetic tests. While genetic tests are a valuable accessory diagnostic tool when ordered by a medical practitioner, there are different implications when they are sold directly to consumers. I aim to show that there are both epistemic and non-epistemic harms associated with the widespread commoditization of DTC genetic tests. I argue that the epistemic harms produced (...) by DTC genetic tests have been disregarded in discussions on the topic. Drawing on the notion of contributory epistemic injustices, I highlight two pertinent epistemic harms: (1) a failure to uptake an individual’s articulations about their identity and (2) the presiding reductionist framework dismisses useful hermeneutical resources. I then propose ways to mitigate these harms. (shrink)

Direct-to-consumer (DTC) genetic tests (GT) enable consumers to access a wide range of GT, without involving a healthcare professional, promoting an increasing disassociation of genetics from the clinical context. This study explores, through semi-structured interviews, the experiences and attitudes of European clinical geneticists towards DTCGT. Our results indicate that the participants have limited experience of consultations with patients regarding such tests. The majority of participants stated that consumers purchased tests out of curiosity and sought a general interpretation (...) of test results by a healthcare professional. Most respondents were skeptical of the quality of tests, especially regarding their clinical utility. The participants supported the importance of medical supervision and genetic counseling in this context. Finally, most respondents considered it their duty to accept consultations concerning DTCGT results. However, due to concerns over limited time and potential downstream costs, some participants supported that a prioritization system based on guidelines would be necessary. (shrink)

Commercial genetic testing offered over the internet, known as direct-to-consumer genetic testing (DTC GT), currently is under ethical attack. A common critique aims at the limited validation of the tests as well as the risk of psycho-social stress or adaption of incorrect behavior by users triggered by misleading health information. Here, we examine in detail the specific role of advertising communication of DTC GT companies from a medical ethical perspective. Our argumentative analysis departs from (...) the starting point that DTC GT operates at the intersection of two different contexts: medicine on the one hand and the market on the other. Both fields differ strongly with regard to their standards of communication practices and the underlying normative assumptions regarding autonomy and responsibility. Following a short review of the ethical contexts of medical and commercial communication, we provide case examples for persuasive messages of DTC GT websites and briefly analyze their design with a multi-modal approach to illustrate some of their problematic implications. We observe three main aspects in DTC GT advertising communication: (1) the use of material suggesting medical professional legitimacy as a trust-establishing tool, (2) the suggestion of empowerment as a benefit of using DTC GT services and (3) the narrative of responsibility as a persuasive appeal to a moral self-conception. While strengthening and respecting the autonomy of a patient is the focus in medical communication, specifically genetic counselling, persuasive communication is the normal mode in marketing of consumer goods, presuming an autonomous, rational, independent consumer. This creates tension in the context of DTC GT regarding the expectation and normative assessment of communication strategies. Our analysis can even the ground for a better understanding of ethical problems associated with intersections of medical and commercial communication and point to perspectives of analysis of DTC GT advertising. (shrink)

While 23andMe aspires to be “the world's trusted source of personal genetic information,” the U.S. Food and Drug Administration (FDA) believes that the company's advertising practices have been anything but trustworthy. Last November, a harshly worded FDA “warning letter” demanded that the direct‐to‐consumer genetic testing company immediately discontinue marketing its unapproved “medical device.” The tussle between 23andMe and the FDA has attracted more attention than a typical disagreement between a company and a government agency. Larry (...) Downes and Paul Nunes identify 23andMe as a “Big Bang Disruption”: an invention that revolutionizes the existing market, foiling both industry incumbents and unprepared regulators. The outcome of the FDA's current review to hold the answer to the million‐dollar question: how will DTC genetic testing be regulated in the future? Ideally, the FDA's regulations should not pose undue burdens on consumers seeking personal genetic information but, rather, help consumers make a transition out of the consumer setting and into the medical setting. (shrink)

In this article we examine commodification and marketisation of genetic testing by companies offering direct-to-consumer genetic testing to the general public through online platforms in Hong Kong. Recently, offers of genetic testing have expanded from scientific and clinical genetic settings to general medicine and non-medical domains. The wider availability of tests, however, has raised concerns about the currently available scientifically proven utility of these tests. Using theme-oriented discourse analysis, we analyse the (...) specific discursive modalities through which the DTC companies in Hong Kong make inflated claims about the value of genetic tests to pursue their marketing agenda. We show that in this way the companies are selling ‘more’ than specific products to consumers: they are selling ‘hope’ and ‘increased autonomy’, that is, an opportunity to buy commodities online that promise consumers control of their health and wellbeing. (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)

Direct to consumer genetic testing has given rise to much controversy, especially in relation to testing for health diagnostic purposes. This paper will consider whether consumers' use of DTC genetic testing should be understood as predominantly recreational. It will be argued that recreational testing can encompass all information domains, including most kinds of predictive health risk information. In relation to recreational testing the potential identity implications for the consumer become a (...) significant concern, more so than the risks more traditionally associated with genetic testing. It will be concluded that while the DTC genetic testing sector is beset by numerous problems and an increase in consumers' genetic literacy is highly desirable, consumers' engagement with DTC genetic testing may be less problematic than sometimes assumed. (shrink)

The recent boom of direct-to-consumer (DTC) genetic tests, aimed at measuring children?s athletic potential, is the latest wave in the ?pre-professionalization? of children that has characterized, especially but not exclusively, the USA in the last 15 years or so. In this paper, I analyse the use of DTC genetic tests, sometimes coupled with more traditional methods of ?talent scouting?, to assess a child?s predisposition to athletic performance. I first discuss the scientific evidence at the basis of (...) these tests, and the parental decision in terms of education, and of investing in the children?s future, taken on the basis of the results of the tests. I then discuss how these parental practices impact on the children?s right to an open future, and on their developing sense of autonomy. I also consider the meaning and role of sports in childhood, and conclude that the use of DTC genetic tests to measure children?s athletic potential should be seen as a ?wake up? call for other problematic parental attitudes aimed at scouting and developing children?s talent. (shrink)

This article reviews recent developments in health care law, focusing on controversy at the intersection of health care law and culture. The article addresses: emerging issues in federal regulatory oversight of the rapidly developing market in direct-to-consumer genetic testing, including questions about the role of government oversight and professional mediation of consumer choice; continuing controversies surrounding stem cell research and therapies and the implications of these controversies for healthcare institutions; a controversy in India arising at (...) the intersection of abortion law and the rights of the disabled but implicating a broader set of cross-cultural issues; and the education of U.S. health care providers and lawyers in the theory and practice of cultural competency. (shrink)

Personalized genomics companies (PG; also called ‘direct-to-consumer genetics’) are businesses marketing genetic testing to consumers over the Internet. While much has been written about these new businesses, little attention has been given to their roles in science communication. This paper provides an analysis of the gene concept presented to customers and the relation between the information given and the science behind PG. Two quite different gene concepts are present in company rhetoric, but only one features in (...) the science. To explain this, we must appreciate the delicate tension between PG, academic science, public expectation, and market forces. (shrink)

Despite the benefits biobanks are expected to bring, there have recently been concerns raised that the public and private non-profit biobanks still prevailing in Europe often fail to reach their initial objectives due to a variety of reasons, including a shortage of funding and insufficient utilization of collections. The necessity to find new ways to manage biobanks has been clearly recognized and one way to do this is to follow the success of some commercial direct-to-consumer genetic (...) class='Hi'>testing companies in the biobanking field. This paper is focused on a double role the return of individual health related findings detected through the biobanking activities can play in the management of biobanks. These findings can be seen as an untapped opportunity to offer health related information to biobank participants. At the same time, the IHRF policy can also serve as an additional tool that can improve biobanking governance. This paper aims to consider diverse IHRF approaches as well as to explore some key ethical concerns related to them. In particular, it reveals how different accounts of personal autonomy shape consent policies related to IHRF and emphasizes ethical controversies related to the commercial DTC GT initiatives as well as some non-profit biobanks. (shrink)

Personal genetic information services (PGI) or direct-to-consumer genomics (DTC) presents a convergence of web 2.0 platforms with consumer-oriented genetics that brings together issues of policy and design. The rise of networking over DNA profile and biodata (bionetworking) challenges the common design and HCI notions of interaction, social networking and user needs. It confronts design thinking and HCI with various biopolitical and biosocial issues discussed in STS studies. These interfaces intensify the troubled relationship between what is social (...) and biological, collective and individual, public and private, natural and political, material (embodied) and based on data or discourses. At the same time, this fast evolving convergence of biosciences with social networking transforms scientific practices in a way which demonstrates the importance of design in discussing issues of STS and policy. The notion of cosmopolitics as "collective experimentation" and "progressive composition of the common world" (Bruno Latour) offers a framework for understanding this connection between philosophy, policy and design. Bionetworking interfaces in this sense serve as probes for testing future collectives which transform the notions of human subjects, community and politics. (shrink)