On June 3, 2003, the European Council of health ministers rejected a proposal from the European Commission to allow drug manufacturers to advertise directly to particular groups of patients; the proposal had already been rejected by the European Parliament subsequent to a heated public debate in which consumer and patient groups almost unanimously argued that it was not the role of drug companies to provide information to patients. The pilot scheme suggested by the Commission would only have applied to (...) patients with three chronic diseases, AIDS, diabetes, and asthma, and would, it was argued, not undermine an overall ban. Drug companies would have been required to abide by a special code of conduct and clear any information given to patients—on web sites or in specialized publications—with national authorities. (shrink)

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)

Genetic testing is currently subject to little oversight, despite the significant ethical issues involved. Repeated recommendations for increased regulation of the genetic testing market have led to little progress in the policy arena. A 2005 Internet search identified 13 websites offering health-related genetic testing for direct purchase by the consumer. Further examination of these sites showed that overall, biotech companies are not providing enough information for consumers to make well-informed decisions; they are not consistently offering genetic counseling services; (...) and some sites even offer tests with little evidence of clinical value. This article aims to raise company and consumer awareness about the ethical concerns surrounding the direct-to-consumer marketing of health-related genetic tests. It also suggests ways that biotech companies can bring their services to the public in an ethically responsible manner, without increased regulatory oversight. (shrink)

With direct-to-consumer advertisements (DTCA), pharmaceutical companies can market their prescription drugs directly to consumers. In order to properly study the argumentative aspect of these advertisements from a pragma-dialectical perspective, it is necessary to characterize DTCA as an ‘argumentative activity type’. This characterization shows that in DTCA, the advertiser combines two genres of communicative activity: promotion and consultation. The use of promotion stems from the advertiser’s commercial objective of selling products, while the use of consultation is a result of (...) the legal obligation to present a fair balance between arguments for and against the use of a drug. (shrink)

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we (...) argue that current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (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)

Broad genome‐wide testing is increasingly finding its way to the public through the online direct‐to‐consumer marketing of so‐called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision‐making with regard to the testing offer, we (...) argue that current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns (...) raise very similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (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)

A case study in the kinds of problems to expect from this increasingly popular marketing tactic.

Understanding of the human genome and its functional significance has increased exponentially since the completion of the Human Genome Project in 2003. The HGP fueled the discovery of more than 1,800 disease genes and paved the way for researchers to identify and test for genes suspected of causing inherited diseases. Currently, there are more than 1000 genetic tests for human diseases and conditions on the market. These tests can play an integral role in the delivery of health care by providing (...) information that could potentially form the basis for profound life decisions, such as whether to undergo a prophylactic mastectomy, whether to terminate a pregnancy, or whether to take a particular drug or medication dose. (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 (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)

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 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)

The aim of the Directive 2005/29 on unfair commercial practices is to contribute to the proper functioning of the internal market and achieve a high level of consumer protection by way of approximation of the laws, regulations and administrative provisions of Member States relating to the elimination of these practices. As announced to the European Commission’s Green Paper, the Commission felt that the existing regulations in the Member States in that the regard to show significant differences causes legal uncertainty (...) and barriers to the operation of the internal market, including building consumer confidence in cross-border transactions. The advantage of the full unification of the law is to strengthen the autonomy of Community law, the achievement of effectiveness. It is questionable whether it is due to the subject matter which is the maximum harmonization discussed act will actually serve to protect economic interests of the consumer. In particular, it undermines the treaty-legal basis, which clearly is aimed at strengthening the single market. Also changes in the Lisbon Treaty, particularly Article 3 TEU, are aimed at establishing the internal market. In the last judgments, like on 9 November 2010 we find that Directive 2005/29 must be interpreted as precluding a national provision, which lays down a general prohibition on sales with bonuses and is not only designed to protect consumers but also pursues other objectives. Does the new act in consequence of the implementation of the national member states give great scope for the flexible operation and may become an effective instrument of pressure to improve business practices? (shrink)

The growth in the direct-to-consumer genetic testing industry poses a number of challenges for healthcare practice, among a number of other areas of concern. Several companies providing this service send their customers reports including information variously referred to as genetic ethnicity, genetic heritage, biogeographic ancestry, and genetic ancestry. In this article, we argue that such information should not be used in healthcare consultations or to assess health risks. Far from representing a move toward personalized medicine, use of this (...) information poses risks both to patients as individuals and to racialized ethnic groups because of the way it misrepresents human genetic diversity. (shrink)

In recent years consumer law has come more and more into the focus of legislation within the EU. One of the EU’s key objectives, completing the final stage of the internal market, is to place consumer rights in the centre of it. Following the adaption of various consumer law measures for some decades, the EU has undertaken a thorough review of its consumer acquis. After years of consultations, the Consumer Rights Directive 2011/83/ EU, which was (...) supposed to set new standards of consumer protection, came into force and will have to be implemented by the Member States by 13 December, 2013. Renouncing its principal practice of minimum harmonisation in the area of consumer law, i.e. allowing Member States on the basis of Directives to adopt more protective rules, the EU legislator now turned to a targeted full harmonisation approach by means of the Consumer Rights Directive, aiming at increasing the consumer protection across the EU by bringing together the currently distinct laws for distance selling and off-premises contracts as well as other types of consumer contracts in a single instrument. The article briefly introduces the background of the Directive and discusses the shift in means of harmonisation concepts. Then, it analyses the scope, concepts and content of the Directive, which mainly brings considerable reforms in the areas of information requirements and the right of withdrawal. Taking into account the Directive’s improvements and shortcomings, conclusions are drawn that further harmonisation and a uniform and universally applicable set of European consumer rights are needed. (shrink)

The article analizes the several times of Proclus‘s reception by Nicholas of Cusa’s thought. The direct reading of Proclus can be established because Expositio in Parmenidem Platonis –Cod.Cus. 186– and Elementatio theological –Cod.Cus.195– (Moerbeke’s translation) and De theologia Platonis Libri VI –Cod.Cus.185– (Petrus Balbus’s translation) are in his Library in Bernkastel-Kues with his marginalia. The assimilation of doctrines can be considered assuming that the implicits and explicits references to Plato’s Diadochus, especially in the last works.

The accurate delineation of various forms of business organization requires a comparative analysis of their objectives, functions, and organizational structures. In particular, this paper highlights differences in managerial work between business firms and non-profits exemplified by the charitable organization. It adopts as its template the theory of the marketing firm, a depiction of the modern corporation as it responds to the imperatives of customer-oriented management, namely consumer discretion and consumer sophistication. It describes in §2 the essentials of (...) the theory and its basis in consumer behavior analysis, and outlines its unique position as the organization responsible for marketing transactions, based on objective exchange, competitive markets and prices, and the deployment of the entire marketing mix. §3 deals in greater depth with the objective, strategic functions, and organization of the marketing firm in terms of the concepts of metacontingency and bilateral contingency. §4 discusses how the marketing firm differs from charities in terms of goal separation, market-based pricing and competition, the entrepreneurial process, the pursuit of customer-oriented management, and organizational structure. Particular attention is accorded the organizational differences between marketing firms and charities, which arise as a direct consequence of the distinct patterns of contingency they entail. §5 discusses the implications of the foregoing analysis and draws appropriate conclusions. (shrink)

Direct-to-consumer advertising (DTCA) of prescription drugs has been a heavily contested issue over the past decade, touching on several issues of responsibility facing the pharmaceutical industry. Much research has been conducted on DTCA, but hardly any studies have discussed this topic from a corporate social responsibility (CSR) perspective. In this article, we use several elements of CSR, emphasising consumer autonomy and safety, to analyse differences in DTCA practices within two different policy contexts, the United States of America (...) and the European Union (EU). Doing so results in an alternative analysis of the struggle between proponents and opponents of DTCA from a CSR perspective, adding an alternative view on this debate. (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...

Live streaming e-commerce, as a kind of new information technology-based business model, is currently the most popular marketing approach, especially in China. This research divides live streaming interactions into three dimensions, interactions for obtaining product information, interactions for grasping the purchase dynamics of others, and interactions for obtaining monetary incentives, and proposes a comprehensive framework to examine whether live streaming interactions with consumers promote both social presence and consumer conformity, and thereby enhance their purchase intentions. Covariance-based structural equation (...) modeling with AMOS was conducted to analyze data collected from 576 Chinese consumers. The main findings are that, first, both IPI and IPD can exert a direct impact on social presence and consumer conformity; second, IMI has a positive impact only on social presence; third, among the three dimensions of interactions, both IPI and IPD tend to increase purchase intention through social presence and consumer conformity, while IMI increases purchase intention only via social presence. Furthermore, given the differences between experience and search products, the results of the multigroup analysis indicate inconsistent path coefficients between the two product groups. This study provides a novel perspective on live streaming e-commerce with evidence on how interactions matter in driving purchase intentions, enriches the content of live streaming e-commerce literature and explores the practical implications for marketing managers are looking for marketing by live streaming. (shrink)

Loi recently proposed a libertarian right to direct to consumer genetic testing — independent of autonomy or utility—reflecting Cohen’s work on self-ownership and Hohfeld’s model of jural relations. Cohen’s model of libertarianism dealt principally with self-ownership of the physical body. Although Loi adequately accounts for the physical properties of DNA, DNA is also an informational substrate, highly conserved within families. Information about the genome of relatives of the person undergoing testing may be extrapolated without requiring direct engagement (...) with their personal physical copy of the genome, triggering rights and interests of relatives that may differ from the rights and interests of others, that is, individual consumers, testing providers and regulators. Loi argued that regulatory interference with exercise of the right required justification, whereas prima facie exercise of the right did not. Justification of regulatory interference could include ‘conflict with other people’s rights’, ‘aggressive’ use of the genome and ‘harming others’. Harms potentially experienced by relatives as a result of the individual’s exercise of a right to test include breach of genetic privacy, violation of their right to determine when, and if, they undertake genetic testing and discrimination. Such harms may justify regulatory intervention, in the event they are recognised; motives driving ‘aggressive’ use of the genome may also be relevant. Each of the above criteria requires clarification, as potential redundancies and tensions exist between them, with different implications affecting different groups of rights holders. (shrink)

Direct-to-consumer advertising (DTCA) of prescription drugs has been a heavily contested issue over the past decade, touching on several issues of responsibility facing the pharmaceutical industry. Much research has been conducted on DTCA, but hardly any studies have discussed this topic from a corporate social responsibility (CSR) perspective. In this article, we use several elements of CSR, emphasising consumer autonomy and safety, to analyse differences in DTCA practices within two different policy contexts, the United States of America (...) and the European Union (EU). Doing so results in an alternative analysis of the struggle between proponents and opponents of DTCA from a CSR perspective, adding an alternative view on this debate. (shrink)

In recent years, online direct-to-consumer pharmaceutical companies have been created as an alternative method for individuals to get prescription medications. While these companies have noble aims to provide easier, more cost-effective access to medication, the fact that these companies both issue prescriptions as well as distribute and ship medications creates multiple ethical concerns. This paper aims to explore two in particular. First, this model creates conflicts of interest for the physicians hired by these companies to write prescriptions. Second, (...) the lack of direct contact from physicians may be harmful to prospective patients. After analysing these issues, this paper argues that there ought to be further consideration for regulation and oversight for these companies. (shrink)

Direct to consumer genetic testing offered via the Internet has been available for over a decade. Initially most tests of this type were offered without the input of the consumer’s own health professional. Ethical and practical concerns have been a raised over the use of such tests: these include fulfilling the requirement for informed consent, utility of results for health care management and the potential burden placed upon health services by people who have taken tests.

BackgroundIn the 1970s, the Federal Trade Commission declared that allowing medical providers to advertise directly to consumers would be “providing the public with truthful information about the price, quality or other aspects of their service.” However, our understanding of the advertising content is highly limited.ObjectiveTo assess whether direct-to-consumer medical service advertisements provide relevant information on access, quality and cost of care, a content analysis was conducted.MethodTelevision and online advertisements for medical services directly targeting consumers were collected in two (...) major urban centres in Nevada, USA, identifying 313 television advertisements and 200 non-duplicate online advertisements.ResultsBoth television and online advertisements reliably conveyed information about the services provided and how to make an appointment. At the same time, less than half of the advertisements featured insurance information and hours of operation and less than a quarter of them contained information regarding the quality and price of care. The claims of quality were substantiated in even fewer advertisements. The scarcity of quality and cost information was more severe in television advertisements.ConclusionThere is little evidence that medical service advertising, in its current form, would contribute to lower prices or improved quality of care by providing valuable information to consumers. (shrink)