A Lack of Proper Counseling
There are, however, less obvious but even bigger dangers that may result from this DTC marketing campaign. A major concern among cancer genetics experts is that women may have their test results misinterpreted, which has already been shown to occur frequently. This could lead to unnecessary prophylactic surgery or false reassurance about their risks to develop cancer and a resultant lack of screening that could save their lives.
This danger stems from a clear conflict of interest. Sales representatives sell primary care physicians on ordering their own testing after only a few hours of training and educational materials provided by the testing company. Unfortunately, well-meaning healthcare providers may be unknowingly taking on a huge liability as they sign off on each test request indicating that they have adequately informed their patient and are ultimately solely responsible for the case.
Materials advertising this test to providers imply that genetic counseling and testing for BRCA1 and BRCA2 mutations is a simple process that any provider can offer with help from the company. In fact, representatives from the firm suggest that many physicians can directly discuss results with their patients and only a select group of people with more complex family histories should be referred to genetic counselors.
This statement is in stark contrast to numerous regional, national, and international studies demonstrating that nongeneticist healthcare providers have inadequate knowledge of the essential clinical genetics concepts. Such an understanding is necessary to provide adequate counseling and interpret results. There is also data to suggest that many providers do not routinely collect a sufficiently detailed and extensive family history to accurately assess risk and interpret test results.
A very similar pilot campaign, which was run by Myriad in Atlanta and Denver in 2002, met with strong criticism. There were numerous unfavorable articles, editorials, and news stories. Outcome studies from this campaign showed that it did not meet its stated educational goals; there was no evidence of an increase in knowledge among providers or consumers in the pilot cities. Providers in both the pilot and comparison cities still lacked the necessary understanding to counsel their patients about BRCA testing.
One outcome that is of particular concern is that these providers who were shown to be incapable of appropriate counseling reported an increase in the number of BRCA tests ordered directly. Yet, there was no increase in the number of referrals to genetic counseling centers.
Although the campaign did increase the demand for genetic counseling and testing among high-risk women, it also increased the demand for genetic counseling among many low-risk women as the proportion of referrals of high-risk individuals declined during the campaign.
Myriad’s current DTC campaign has raised concern among healthcare providers and captured the attention of Richard Blumenthal, attorney general of Connecticut, who has issued a subpoena for information from Myriad to determine whether or not the claims in its advertisements are fair and accurate. He has indicated that both the tone and the content of the commercials are troubling.
In the absence of better regulation, industry leaders, healthcare providers, and professional organizations should collaborate to set and adhere to standards for socially responsible genetic testing and marketing of genetic testing to minimize the risks and maximize the benefits for all parties involved.