Direct to consumer (DTC) advertising has attracted significant research attention, yet none has focused on empirical assessments of its overall impact on U.S. consumers nationally, and tying assessment to relevant behavioral outcomes. This paper addresses the ethical issue of DTC advertising providing a balance of product and risk information that is both understandable and believable, and contributes direction to those exploring this phenomenon.

The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information (PGI) direct-to-consumers. Companies such as 23andme (Mountain View, CA) and Navigenics (Foster City, CA) are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social (...) networking business ventures that market the science of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information—openly sharing of data with all interested parties, not just the biomedical researcher—for the purposes of pooling data (increasing statistical power) and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis. (shrink)

Direct to consumer (DTC) advertising has attracted significant research attention, yet none has focused on empirical assessments of its overall impact on U.S. consumers nationally, and tying assessment to relevant behavioral outcomes. This paper addresses the ethical issue of DTC advertising providing a balance of product and risk information that is both understandable and believable, and contributes direction to those exploring this phenomenon.

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)

There is currently little evidence that the information provided by personal genomics companies—such as 23andMe and Navigenics—on a direct-to-consumer (DTC) basis, has any real health value. To be...

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 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)

New Institutional Theory is used to explain the context for argumentation in modern practice. The illustration of Direct to Consumer Drug advertising is deployed to show how communicative argument between a doctor and patient is influenced by force exogenous to the practice of medicine. The essay shows how strategic maneuvering shifts the burden of proof within institutional relations.

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)

Direct to consumer advertising has attracted significant research attention, yet none has focused on empirical assessments of its overall impact on U.S. consumers nationally, and tying assessment to relevant behavioral outcomes. This paper addresses the ethical issue of DTC advertising providing a balance of product and risk information that is both understandable and believable, and contributes direction to those exploring this phenomenon.

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)

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)

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)

The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information direct-to-consumers. Companies such as 23andme and Navigenics are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking business ventures that market the science (...) of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information—openly sharing of data with all interested parties, not just the biomedical researcher—for the purposes of pooling data and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis. (shrink)

In the target article, McGuire and colleagues (2009) found that 54% of social networkers would consider using direct-to-consumer personal genome testing (DTC PGT) for their child and that 63% agree...

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)

Direct-to-Consumer genomics has been a controversial topic for over a decade. Much work has been done on the legal issues it raises. This article asks a different question: What will DTC genomics and its legal issues look like in ten to twenty years? After discussing the five current uses of DTC genomics, it describes three current legal issues: medical uses, privacy of genomic information, and privacy in collection and analysis of human DNA. It then suggests that changes in (...) human genomics and how it is used will make the first of those DTC genomics legal issues less important in the future, but that the third will be increasingly significant. (shrink)

This study is rooted in the research traditions of cultivation theory, construct accessibility, and availability heuristic. Based on a survey with 221 subjects, this study finds that familiarity with direct-to-consumer (DTC) print advertisements for antidepressant brands is associated with inflated perceptions of the prevalence and lifetime risk of depression. The study concludes that DTC advertising potentially has significant effects on perceptions of depression prevalence and risk. Interpersonal experiences with depression coupled with DTC advertising appear to significantly predict individuals’ (...) perceived lifetime risk of depression. The study ultimately demonstrates that DTC advertising may play a role in constructing social reality of diseases and medicine. The findings strongly suggest that the social cognitive effects of DTC advertising are far-reaching, impacting pharmaceutical marketing strategy as well as presenting issues regarding public health and the business ethics of advertising drugs to consumers. (shrink)

Like all interventions in health care, direct-to-consumer advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-unde-monstrated benefits of the advertising.

Like all interventions in health care, direct-to-consumer advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-undemonstrated benefits of the advertising.DTC advertising must be seen in the context of overall pharmaceutical company expenditures on advertising. In 2005, the industry spent $29.9 billion dollars (...) on promotions, of which a relatively small fraction, $4.2 billion, was spent on DTC advertising. The percentage spent on DTC advertising has been relatively constant this decade. Promotions to professionals and samples accounted for far larger percentages of total promotional spending in 2005. (shrink)

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

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)

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)

The purpose of this essay is to make the case that the ethical issues raised by the current U.S. practice of direct-to-consumer prescription drug advertising are worthy of study in philosophy courses, and to provide instructors with some ideas for how they might approach teaching the topic, despite the current relative scarcity of philosophical literature published on it. This topic presents a unique opportunity to cover ground in ethics, critical thinking, and scientific literacy simultaneously. As a case study, (...) the practice of DTC advertising is both theoretically rich and universally relevant to students’ lives. The nature of these ads—numerous, diverse, visually and thematically entertaining—makes them delicious fodder for in-class activities, small group work, discussion-based learning, creative projects, and customizable essay topics. I offer a set of suggestions for approaching the study of DTC drug ads that is informed by my own experience doing so in bioethics courses. Ultimately, including this topic on your syllabus not only contributes to students’ philosophical skills and knowledge, but also helps them become better informed as citizens and potential “consumers” of health care. (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 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)

Like many ethics debates surrounding emerging technologies, neuroethics is increasingly concerned with the private sector. Here, entrepreneurial visions and claims of how neurotechnology innovation will revolutionize society—from brain-computer-interfaces to neural enhancement and cognitive phenotyping—are confronted with public and policy concerns about the risks and ethical challenges related to such innovations. But while neuroethics frameworks have a longer track record in public sector research such as the U.S. BRAIN Initiative, much less is known about how businesses—and especially start-ups—address ethics in tech (...) development. In this paper, we investigate how actors in the field frame and enact ethics as part of their innovative R&D processes and business models. Drawing on an empirical case study on direct-to-consumer (DTC) neurotechnology start-ups, we find that actors engage in careful boundary-work to anticipate and address public critique of their technologies, which allows them to delineate a manageable scope of their ethics integration. In particular, boundaries are drawn around four areas: the technology’s actual capability, purpose, safety and evidence-base. By drawing such lines of demarcation, we suggest that start-ups make their visions of ethical neurotechnology in society more acceptable, plausible and desirable, favoring their innovations while at the same time assigning discrete responsibilities for ethics. These visions establish a link from the present into the future, mobilizing the latter as promissory place where a technology’s benefits will materialize and to which certain ethical issues can be deferred. In turn, the present is constructed as a moment in which ethical engagement could be delegated to permissive regulatory standards and scientific authority. Our empirical tracing of the construction of ‘ethical realities’ in and by start-ups offers new inroads for ethics research and governance in tech industries beyond neurotechnology. (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)

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)