Health Issues in Genetics

Direct to Consumer Marketing of Genetic Tests

Direct to Consumer Advertising Workshop Summary

March 23, 2004

Many genetic testing laboratories have begun to market their tests directly to consumers through print and television advertisements. While this may increase public awareness about the availability of genetic tests, there may also be some risks in adopting this strategy. For instance, some advertisements might not successfully reach at-risk individuals or accurately convey the limitations of genetic testing.

The advertising of health-related products directly to consumers, a $3 billion per year industry, first appeared in the early 1980's with the marketing of prescription drugs in print and television advertisements. As additional genetic testing companies adopt this marketing strategy, more research is needed to evaluate the benefits and consequences of the direct-to-consumer (DTC) marketing of genetic tests.

In 2002, Myriad Genetics, Inc. launched the most notable DTC marketing campaign to date. This campaign included print and television advertisements for BRACAnalysis, a commercial test for the BRCA1 and BRCA2 genes which have been associated with breast and ovarian cancer.1 In Denver, one of the cities in which the ads ran, cancer genetics centers noted a 300% increase in calls from women interested in BRACAnalysis, but a 30% decrease in referral of high risk women during the campaign.2 These data signal a potential failure of the ads to reach the target population of women most likely to benefit from the information gained from BRACAnalysis. Further research showed that the advertisements did not accurately portray the test's ability to predict cancer or encourage consumers to contact their health care provider.3, 4 In 2003, the Food and Drug Administration's (FDA) public meeting to review data of the impact of DTC marketing of prescription drugs also found similar conclusions: advertisements increased consumers' awareness about diseases, but failed to accurately convey risk information.5

In addition to print and television, many companies use the Internet to market their genetic tests to consumers, including clinically available tests pertaining to disorder such as hemochromatosis and cystic fibrosis. Other websites offer genetic tests for nutrition, behavior, and aging.6 A consumer can purchase face cream and supplements formulated specifically for their genetic composition, order a test to predict if they are likely to develop addictive or hyperactive behaviors, and a pregnant woman can have a blood test to see if her fetus has a chromosome abnormality. All of these non-clinical tests lack scientific support, and thus, the validity of the information on these websites' should be thoughtfully assessed.

Marketing on the Internet is particularly worrisome in that it many cases it can provide easy access to genetic tests without involving a health care professional in the testing process. Even the clinically available genetic tests, which may provide legitimate test results, can be difficult to interpret without genetic counseling.

The need for additional oversight of genetic tests, including the marketing of those tests, was evaluated in July 2000, by the Secretary's Advisory Committee on Genetic Testing and in September 2003, by the Secretary's Advisory Committee in Genetics, Health and Society evaluated.7 Currently, the Centers of Disease Control (CDC), Centers for Medicare Services (CMS), FDA, have oversight of genetic tests and products, while the Federal Trade Commission (FTC) has oversight of the advertising of these tests and products. The National Institutes of Health, Health Resources and Services Administration (HRSA) and Agency for Healthcare Research and Quality (AHRQ) support research related to genetic tests and products.

Genetic test results not only apply to the individual across his/her entire lifespan, but have implications to other family members as well. Therefore, it will be important for sound public policy to be developed in the area of oversight in both the provision and marketing of such tests.

References

  1. December 16, 2003: Myriad Genetics Launches Direct to Consumer Advertising Campaign for Breast Cancer Test. Myriad Genetics Inc.
     
  2. Mouchawar J, Hensley-Alford S, Kulchak-Rahm A, Ellis J, Ritzwoller D, Meenan R and Finucane M. Impact of Direct-to-Consumer Advertising for BRACAnalysis on Genetic Counseling Referrals at a Managed Care Organization. Journal of Genetic Counseling 2003, Annual Education Conference Abstracts.
     
  3. Gollust SE, Hull SC, Wilfond BS. Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing. JAMA, 288(14): 1762-1767. 2002 [PubMed]
     
  4. Hull SC, Prasad K. Reading Between the Lines: Direct-to-Consumer Advertising of Genetic Testing in the USA. Reproductive Health Matters, 9(18):44-48. 2001 [PubMed]
     
  5. Direct-to-Consumer Promotion: Public Meeting, September 22-23, 2003. Food and Drug Administration, Washington, D,C.
     
  6. Gollust SE, Wilfond BS, Hull SC. Direct-to-Consumer Sales of Genetic Services on the Internet. Genetics and Medicine, 5(4):332-337. 2003. [PubMed]
     
  7. Enhancing the Oversight of Genetic Tests: Recommendations of the Secretary's Advisory Committee on Genetic Testing (SACGT)
    July 2000.
    • Appendix A
      Secretary's Advisory Committee on Genetic Testing Federal Register Notice of Meeting
    • Appendix B
      Public Comments on Preliminary Conclusions and Recommendations on Oversight
       

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Last Updated: March 11, 2014