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)

The influence of direct-to-consumer advertising and physician promotions are examined in this study. We further examine some of the ethical issues which may arise when physicians accept promotional products from pharmaceutical companies. The data revealed that direct-to-consumer advertising is likely to increase the request rates of both the drug category and the drug brand choices, as well as the likelihood that those drugs will be prescribed by physicians. The data further revealed that the majority of responding (...) physicians were either neutral or did not feel that accepting some types of gifts from pharmaceutical companies affected their ethical behaviors. (shrink)

: From its founding in 1847, the AMA divided drugs into "ethical" and "unethical" preparations. Those that were ethical had a known composition and were advertised only to the profession. Others, patent medicines (technically proprietary drugs, whose trademarks were protected by copyright), were sold directly to the public. In spite of the AMA's efforts to ban the advertising and sale of these nostrums, proprietary drugs flourished during the nineteenth century. Starting in 1900, however, three major societal trends combined to bolster (...) the AMA's campaign, and by 1920 almost all advertising was directed to physicians, who would then prescribe medications to their patients. This ban on advertising pharmaceuticals directly to the public remained virtually unchanged until approximately 1980. Since then, it has slowly eroded and, as recently as 1997, the FDA created guidelines for pharmaceutical companies to advertise on television. What does this change say about the profession of medicine, the role of the physician in society, and the doctor-patient relationship? Using a comparative historical approach, this paper examines these issues. (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)

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)

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)

Background: Discussing direct-to-consumer advertising of prescription drugs during a visit could affect prescribing practices and provider–patient relationship. Research objectives: The study examines advanced practice nurse prescribers’ perceptions of direct-to-consumer advertising and its effects on nurse–patient relationship, prescriptive authority, and appropriateness of patient clinical requests. Research design: A cross-sectional survey design was implemented. Participants and research context: The random sample consisted of 316 nurses (27.17% response rate) in one of the Midwestern states in the United States. Pearson’s (...) chi-square analysis and multiple/multinomial logistic regression analyses were used. Ethical considerations: Permission to conduct the study was obtained from the university’s Institutional Review Board. Participation was voluntary, and measures were taken to protect the anonymity and confidentiality of consenting participants. Findings: Most nurses (69%) believed that patients were “poor or very poor” at assessing the relevance of drug advertisements, 61% reported that the increase in drugs advertisements directed at patient was “a bad or a very bad thing,” and only 16% thought the advertisements were accurate to “a very or to a great extent.” Improved nurse–patient relationship was associated with factors such as the patient not bringing printed material, seeking nurse’s opinion only, taking responsibility for their health, and not challenging nurse’s prescriptive authority. Discussion: Advertising discussion during a visit could improve as well as pose a challenge to a nurse–patient relationship and nurse’s prescriptive authority. Conclusion: The positives of discussing advertising information can be maximized and the negatives minimized through enhanced interpersonal nurse–patient communication. (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.

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)

BackgroundSince 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals, through a direct-to-consumer online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive (...) tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States. However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. Furthermore, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status, and, more recently, to provide consumers with “carrier status” information for 35 genes known to cause disease.DiscussionIn this Debate, we highlight the likelihood that the primary objective of the company was probably two-fold: promoting itself within the market for predictive testing for human genetic diseases and ancestry at a low cost to consumers, and establishing a high-value database/biobank for research and personal information).SummaryBy dint of this marketing approach, a two-sided market has been established between the consumer and the research laboratories, involving the establishment of a database/DNA biobank for scientific and financial gain. We describe here the profound ethical issues raised by this setup. (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...

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)

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)

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)

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.

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)

New Zealand is one of two OECD countries in the world where direct-to-consumer advertising of prescription medicine (DTCA-PM) is permitted. Increase in such activity in recent years has resulted in a disproportionate increase in dispensary volume of heavily advertised medicines. Concern for the potential harm to healthcare consumers and the public healthcare system has prompted the medical profession to call for a ban on DTCA-PM as the best way of protecting the public interest. Such blanket prohibition however also (...) interferes with the public’s right of access to information. This paper will examine if banning DTCA-PM would constitute a justified form of paternalism in the context of today’s New Zealand. (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)

The overarching issue with this case study is poor regulation and quality control over direct-to-consumer genetic testing, delivered in the absence of any medical oversight.

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 genetic testing is a growing phenomenon, fuelled by the notion that knowledge equals control. One ethical question that arises concerns the proband’s duty to share information indicating genetic risks in their relatives. However, such duties are unenforceable and may result in the realisation of anticipated harm to relatives. We argue for a shift in responsibility from proband to provider, placing a duty on test providers in the event of identified actionable risks to relatives. Starting from Parker and (...) Lucassen’s 'joint account model', we adapt Kilbride’s application of the rule of rescue and balance it against the relative’s right not to know, placing responsibility on the providers of direct-to-consumer genetic testing. Where the risk of disease to a relative is actionable, we argue providers ought to share results even in the face of the proband’s objections. Confidentiality issues are navigated by a pre-emptive consent model, whereby consumers agree to the sharing of certain information with their relatives ahead of testing and as a condition of testing. When a relative is informed, the proband’s privacy is protected by maximal deidentification, and the rights of the relative are met by a stepwise approach to informing that allows them to decide how much information they receive. (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)

Purpose: This study explores social networkers' interest in and attitudes toward personal genome testing (PGT), focusing on expectations related to the clinical integration of PGT results. Methods: An online survey of 1,087 social networking users was conducted to assess 1) use and interest in PGT; 2) attitudes toward PGT companies and test results; and 3) expectations for the clinical integration of PGT. Descriptive statistics were calculated to summarize respondents' characteristics and responses. Results: Six percent of respondents have used PGT, 64% (...) would consider using PGT, and 30% would not use PGT. Of those who would consider using PGT, 74% report they would use it to gain knowledge about disease in their family. 34% of all respondents consider the information obtained from PGT to be a medical diagnosis. 78% of those who would consider PGT would ask their physician for help interpreting test results, and 61% of all respondents believe physicians have a professional obligation to help individuals interpret PGT results. Conclusion: Respondents express interest in using PGT services, primarily for purposes related to their medical care and expect physicians to help interpret PGT results. Physicians should therefore be prepared for patient demands for information and counsel on the basis of PGT results. (shrink)

When journalists and health researchers address the subject of patients in the United States undergoing unproven stem cell–based interventions, they have historically crafted narratives about "stem cell tourism" to facilities located in such countries as China, India, Mexico, Panama, and Thailand. These latter nations often are depicted as jurisdictions where clinics providing access to SCBIs operate without meaningful oversight, relevant regulations are nonexistent or have significant loopholes, and regulatory bodies are underfunded, understaffed, corrupt, or otherwise unable to provide effective oversight (...) (Caul-field et al. 2009;... (shrink)

Not too long ago, neurotechnology was the purview of the clinic and research. In 2011, researchers at Brown University succeeded for the first time in using an implanted sensor in the brain of a pa...

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