title: Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests.
abstract: Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society.
authors.affiliation: Social and Behavioral Research Branch, National Human Genome Research Institute/NIH, 2 Center Drive, Bethesda, MD 20892-0249, USA. wadec@mail.nih.gov
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Wade
authors.forename: Benjamin S
authors.initials: BS
authors.lastname: Wilfond
mesh_terms: D002318:Cardiovascular Diseases / Q000235:genetics; D005544:Forecasting; D005817:Genetic Counseling / Q000941:ethics*; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing / Q000941:ethics* / Q000379:methods*; D006801:Humans; D040541:Marketing; D008389:Marketing of Health Services / Q000941:ethics*; D028681:Moral Obligations; D011237:Predictive Value of Tests; D011364:Professional Practice / Q000941:ethics* / Q000639:trends; D015203:Reproducibility of Results