Research
Ethical Issues in Direct-to-Consumer Advertising and Sales of Clinical Genetic Testing
Summary: This project examines the potential benefits and harms of direct-to-consumer advertising and sales of genetic testing services.
| Section: | Ethics and Genetics | ||||||||||||||
| Principal Investigators: | Benjamin Wilfond, M.D Sara Hull, Ph.D. |
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| Collaborators: |
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Background: Direct-to-consumer (DTC) advertising of pharmaceuticals, while controversial, has occurred for many years and has been subject to significant debate and regulatory oversight. In contrast, DTC advertising of genetic testing began almost unnoticed and without regulatory oversight. DTC advertising for a variety of clinical genetic tests has appeared in print media, on television and radio, and on the Internet. The emergence of such advertising over the past 5 to 6 years signals an expanding market for genetic testing services.
Departmental Research Initiative: The Department’s efforts in this area began in response to the first known example of a print DTC advertisement for genetic testing, which was for BRCA1/2 mutation testing. We developed a case report in which we identified some concerning aspects of the advertisement’s content, including overstatements regarding the applicability and resulting benefits of BRCA1/2 testing, inaccurate information about health insurance discrimination, and failure to mention the role of health care professionals in decisions regarding genetic testing (Hull and Prasad, 2001).
We soon identified additional genetic testing advertisements in print media, upon which we developed a framework for evaluating such advertising. We argued that genetic testing advertisements are premature at this time, given that their value to consumers is limited by the complexity of genetic information, the complicated social context surrounding genetic information, and a lack of consensus regarding the clinical utility of genetic testing in many cases (Gollust, Hull, and Wilfond, 2002). We also noted that shared FTC and FDA oversight of DTC advertisements for genetic testing — which was not occurring at that time — would help ensure the accuracy of their content.
Although we initially focused on advertising for genetic tests that were available to consumers only through a health care provider, an Internet-based market for genetic tests that could be purchased directly by consumers without a clinician’s involvement was rapidly emerging. Accordingly, we undertook to assess the volume and nature of genetic services being sold on the Internet directly to consumers (Gollust, Wilfond, and Hull, 2003). Of 105 websites we identified in May 2002 that sold such services, 14 offered health-related genetic tests, ranging from standard tests already available in clinical practice to unconventional applications related to nutrition, behavior, and aging. Few sites discussed the risks associated with testing and the role of genetic counseling. Again, we noted a role for FDA and/or FTC oversight.
The advertising and sale of genetic testing directly to consumers will likely have implications for health professionals, who may be called upon to help consumers interpret results of tests that have not been validated clinically. We explored how DTC strategies are likely to affect genetic counselors specifically, using cardiovascular disease susceptibility tests as an illustration (Wade and Wilfond, 2006). Risk assessment for cardiovascular disease often requires the use of established clinical tests and assessment of family history rather than genetic tests. As such, we argued that genetic counselors are not obligated to order DTC advertised genetic tests at a client’s request if they have minimal validity and utility. However, genetic counselors ought to help clients interpret the results of genetic tests, even if obtained without a clinician’s authorization.
Our analyses uncovered advertisements that were directed to specific ethnic groups — particularly Ashkenazi Jews — suggesting that they were at greater risk for certain genetic diseases and implying that testing would benefit them specifically. Labeling tests in this way might reinforce associations between genetic diseases and particular ethinc groups, making them more vulnerable to discrimination and stigmatization. This led us to examine carrier testing panels for “Jewish genetic diseases” offered by laboratories in the United States (Lieb et al, 2005). We identified 27 laboratories that offered up to ten tests in a panel, with considerable variability in the types of diseases, prices, and labeling of panels. Fifteen panels cost less than if the included tests were ordered individually. We concluded that policy guidance is needed to establish appropriate criteria for inclusion of tests in panels, and that pricing strategies that offer financial incentives for the use of “more tests” should be reexamined.
Impact of Research: Our research team was the first to report the emergence of DTC advertising for genetic testing and to evaluate it systematically using both conceptual and empirical approaches. Our body of research prompted several ongoing investigations at other institutions of the prevalence and impact of genetic testing advertisements; provided a basis for a statement developed by the American College of Medical Genetics; and led to the formation of an NHGRI working group that is developing guidance on “best practices” regarding DTC advertising of genetic testing. In addition, our work brought such advertising to the attention of the FTC and the FDA, who participated in an NHGRI-sponsored policy form on the topic to discuss possible oversight approaches. The FTC issued a consumer fact sheet in July 2006 entitled, At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription, which brought many of the concerns we identified in our series of papers to the attention of the public. The GAO followedup our 2003 study with their recent report on, Nutrigenetic Testing: Tests Purchased from Four Web Sites Mislead Consumers (July 2006).
Authors |
Publication Date |
Citation Number |
Gollust, Hull, and Wilfond |
2002 |
43 |
Hull and Prasad |
2001 |
22 |
Gollust, Wilfond, and Hull |
2003 |
21 |
Current and Future Initiatives: The Department is participating in an NHGRI working group that is developing consumer-focused guidance on interpreting DTC advertisements for genetic testing. Members of the Department have consulted with the Secretary’s Advisory Committee on Genetics, Health, and Society in their investigations of genetic testing services offered over the Internet, which were modeled after our 2003 study. In addition, the Department has contributed to the development of an NHGRI Social and Behavioral Research Branch study that proposes to examine these issues in the context of “multiplex" genetic testing.
Publications:
Wade CH, Wilfond BS. Ethical and clinical practice dilemmas for genetic counselors associated with direct-to-consumer marketing of genetic tests. Am J Med Gen. 2006;142C(4):284-292.
Leib JR, Gollust SE, Hull SC, Wilfond BS. Carrier Screening Panels for Ashkenazi Jews: Is More Better? Genetics In Medicine. 2005;Mar;7(3):185-90.
Gollust SE, Wilfond BS, Hull SC. Direct-to-Consumer Sales of Genetic Services on the Internet, Genetics In Medicine. 2003;5(4):332-337.
Gollust S, Hull SC, Wilfond B. Direct to Consumer Advertising for Genetic Testing (letter). JAMA. 2003;289(1):446.
Gollust S, Hull SC, Wilfond B. The Limitations of Direct-to-Consumer Advertising for Genetic Testing, JAMA. 2002;288(14):1762-1766.
Hull SC, Prasad K. Reading Between the Lines: Direct-to-Consumer Advertising of Genetic Testing. Hastings Center Report. 2001;31(3):33-35 [reprinted in Reproductive Health Matters 2001;9(18):44-48].
