Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing

Abstract

Although direct-to-consumer (DTC) advertisements for pharmaceuticals have been appearing in the mass media for 20 years, DTC advertisements for genetic testing have only recently appeared. Advertisements for genetic testing can provide both consumers and physicians with information about test availability in an expanding market. However, 3 factors limit the value and appropriateness of advertisements: complex information, a complicated social context surrounding genetics, and a lack of consensus about the clinical utility of some tests. Consideration of several advertisements suggests that they overstate the value of genetic testing for consumers' clinical care. Furthermore, advertisements may provide misinformation about genetics, exaggerate consumers' risks, endorse a deterministic relationship between genes and disease, and reinforce associations between diseases and ethnic groups. Advertising motivated by factors other than evidence of the clinical value of genetic tests can manipulate consumers' behavior by exploiting their fears and worries. At this time, DTC advertisements are inappropriate, given the public's limited sophistication regarding genetics and the lack of comprehensive premarket review of tests or oversight of advertisement content. Existing Federal Trade Commission and Food and Drug Administration regulations for other types of health-related advertising should be applied to advertisements for genetic tests.

The strategic defense of physician autonomy: State public health agencies as countervailing powers

“…Some research has suggested that lay consumers are especially vulnerable to the claims of testing companies, because they lack a nuanced understanding of genetics and the complex considerations in risk stratification (Gollust, Hull, & Wilfond, 2002). By emphasizing the importance of the physician as gatekeeper, the state agencies placed a buffer between commercial testing laboratories and naïve consumers.…”

Introduction to the Special Section on Genomics

“…Both the Introduction and the Section do not do justice to many aspects of genetics and genomics. Among issues not covered are those pertaining to: managing (Hawkins et al., ) genomic data, as this poses a unique challenge to protecting participant confidentiality; using genomic testing for diagnostic and predictive purposes, as well as direct‐to‐consumer genetic testing (Gollust, Hull, & Wilfond, ); educating the public and various professionals who will need to understand and interpret various genetic tests; handling ethical considerations pertaining to the near‐ubiquitous presence of new information related to or generated by the Human Genome Project; and numerous other topics introduced or crystallized by the Project. We are hopeful that this Special Section will have multiple sequels.…”

Virtual research visits and direct-to-consumer genetic testing in Parkinson’s disease

“…Remote recruitment and conduct of research visits in individuals who have undergone DTC genetic testing is feasible, shows relatively good agreement with self-reported data, and is well received by participants. While the benefits of DTC genetic testing continue to be debated, 1 , 2 , 11 , 31 – 39 this proof of concept study demonstrates its potential to identify, follow, and engage geographically dispersed populations with a given disorder and an underlying genotype in research. 40 Our 32% response rate to a single recruitment email suggests that targeted electronic recruitment in populations unrestricted by geography may improve participation in research studies.…”