Abstract
The intention of this letter is to clarify the distinction between direct to consumer testing versus direct to consumer advertising. The introduction of this article used the definition from the Genetics Home Reference 2011 to define direct-to-consumer (DTC) genetic tests. This definition specifically states that “…genetic tests…..Allow a person to obtain genetic information without involving a doctor or insurance company in the process and provides an estimate of an individual's statistical risk for developing a specific health condition”. The introduction's second paragraph immediately after this definition states, “Myriad Genetics launched the first major DTC publicity campaign for its BRCA1/BRCA2 tests…” This unfortunately and inaccurately implies that Myriad's products, as supported by public awareness campaigns, are DTC genetic tests. Myriad's products are not DTC genetic tests because they must be ordered by a licensed health care professional. Patients cannot directly order these tests. Myriad's public awareness campaigns that have taken place in various parts of the country are, as the name implies, meant to raise awareness about the importance of family history as it relates to cancer risk. Each geographical location was carefully selected after evaluating that there were qualified healthcare personnel in those areas to address patient concerns after seeing the public awareness campaign. Consumers who saw these commercials or advertisements could not simply order a test and then get medical information back without involving a healthcare provider. If a consumer called Myriad directly, they were encouraged to talk to their own physician or directed to a healthcare provider near them who could discuss their family history with them. Specifically and to the point, Myriad's operations, including its public awareness campaign, do not “allow a person to get genetic information without involving a doctor.” Thus, Myriad's products by definition are not DTC products. Conflating DTC advertising and DTC testing as the authors have done introduces unhelpful ambiguity and potential confusion into an important debate over the appropriateness of offering genetic testing directly to the general public. There are important differences between raising public and provider awareness about the importance of family history (DTC advertising) and enabling a consumer to directly order a genetic test (DTC genetic testing). In fact, public awareness campaigns such as Myriad's and the Surgeon General's Family Health History Initiative, which is “to encourage all American families to learn more about their family health history,” (Surgeon General's Family Health History 2012) are likely to help resolve the primary concern raised over DTC genetic testing: lack of education amongst general consumers regarding genetic testing's power and limitations. The authors’ original research highlighted the many variables that impact the disparities in the awareness of genetic testing, numeracy, communication and interpretation of risk information. As the authors accurately stated in the article, “there is no consensus in the field on the best way to present health information” but the key is that it is discussed and made available to ALL at risk patients in a manner they can understand, regardless of race, ethnicity, religion, socioeconomic status or education. However, the implication that Myriad's products are DTC genetic tests could possibly have skewed this study's results since the participants might believe that the information they heard about BRCA through a Myriad public awareness campaign (DTC advertising) is the same as DTC genetic testing, which is clearly not the case.
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