Abstract
This paper provides a marketing ethics analysis that addresses the practice of selling genetic tests (GT) directly to the consumer (DTC). 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.
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Notes
To illustrate: A sensitivity of 80% means that the test detected 80% of people with the condition but 20% did not get detected. However, sensitivity does not say anything about how many people had a positive test result but don’t have the condition.
To illustrate: A specificity of 80% means that the test detected 80% of people who do not have the condition but (falsely) identified 20% as positive who do not have the condition. However, specificity says nothing about the probability of false positive tests.
The American Medical Association’s ethics code specifically suggests:
“Protecting information gathered in association with the care of the patient is a core value in health care”.
The American Medical Association’s ethics code specifically suggests:
(a) Disclose potential commercial applications to the tissue donor before a profit is realized on products developed from biological materials.
(b) Obtain informed consent to use biological materials in research from the tissue donor. Human biological materials and their products may not be used for commercial purposes without the consent of the tissue donor.
(c) Share profits from the commercial use of human biological materials with the tissue donor in accordance with lawful contractual agreements.
Knowing one’s talents might be empowering but commercially available talent tests do not (yet?) live up to this promise (Phillips 2016).
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Appendix
Appendix
See Table 2.
Abstracts of three seminal business journal articles:
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Analyzing the activities of one of the largest DTC companies (23andMe), Merz (2016) shows the conflation of production and consumption for certain demographic sectors. She argues that by targeting especially African Americans, this ‘prosumption’ relies for its success on both the labor of African American ‘prosumers’ and on the prior system of racial signification through which corporeal matter and genetic information appear interesting. Put differently, Black consumers in America are particularly disposed to want to know more about their genetic past. Merz (2016).
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Reflecting emergent concerns, Liu and Pearson (2008) provide an excellent overview (now over ten years old) of the regulatory environment for DTC GT in the USA. They performed a content analysis of the websites of 46 DTC companies offering predictive genetic tests (tests that determine whether an individual is a carrier and/or if the individual has an increased susceptibility to a disease). Their analysis concludes that “the combination of consumer ignorance, scant government regulation, aggressive marketing practices, and the often-overzealous media attention to genetic testing is a recipe for harm to individual consumers and public health” (Liu and Pearson 2008). Accordingly, they recommend only offering GT through a physician and prohibiting DTC marketing of genetic tests that lack analytic or clinical validity. Liu and Pearson (2008).
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In a significant study of DTC GT, Berg and Fryer-Edwards (2008) identified and analyzed the websites of 13 companies offering health-related GT directly marketed to consumers. Their study “suggests that biotech companies are not providing balanced information about the risks and benefits of genetic testing; they are not consistently offering genetic counseling services; and some sites are even offering tests with little evidence of clinical value” (Berg and Fryer-Edwards 2008, p. 29). At that time, the authors’ three main recommendations to companies for ethical DTC Genetic Test marketing were (1) provide enough information for consumers to make an educated decision, (2) only offer genetic tests with clinical validity, and (3) reduce the potential for misinterpreting results. These guidelines have rarely been followed by the industry. As discussed below, while the number of companies offering DTC GT has dramatically increased since this study was done more than 10 years ago, the overall recommendations of this study are still relevant today. Berg and Fryer-Edwards (2008)
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Nill, A., Laczniak, G. Direct-to-Consumer Genetic Testing and Its Marketing: Emergent Ethical and Public Policy Implications. J Bus Ethics 175, 669–688 (2022). https://doi.org/10.1007/s10551-020-04632-z
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DOI: https://doi.org/10.1007/s10551-020-04632-z