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Originally published as JCO Early Release 10.1200/JCO.2003.12.069 on July 21 2003 © 2003 American Society for Clinical Oncology
Direct-to-Consumer Marketing of Genetic Tests for Cancer: Buyer BewareCenter for Clinical Cancer Genetics, Department of Medicine, and University of Chicago Pritzker School of Medicine, Chicago, IL BREAST CANCER runs in my family. My mother... my grandmother... my dad’s sisters... I wondered if it would be... inevitable. I found out that it didn’t have to be. I found out my risk through BRCAnalysis... BRCAnalysis can help you see the big picture, so that you can take steps to reduce your risk."1 Advertisements like this challenge us to critically examine the emerging role of genetics in medicine and our duties as health care providers. At the 50th anniversary of the discovery of the DNA helix, are we trained and prepared to guide patients through the complexities of genetic testing, or will we simply order a genetic test at a patient’s request? During the past 20 years, we have witnessed a dramatic increase in our understanding of the role of genetic alterations that are often central to the diagnosis, classification, prognosis, and treatment of malignant diseases. Genetic testing for certain disorders, such as breast and colon cancers, have helped to identify patients and families at high risk, shifting the emphasis of care from treatment to prevention and preclinical detection of disease. While the majority of breast cancer cases occur sporadically, it is estimated that 5% to 10% of cases are caused by inherited mutations in breast cancer susceptibility genes such as BRCA1 and BRCA2.2 BRCA1 and BRCA2 mutations are highly penetrant, and confer a lifetime probability of developing breast cancer of 56% to 87% and 37% to 85%, respectively, making these the strongest known predictors of breast cancer.3–5 Significant advances in prevention, primarily by prophylactic mastectomy and oophorectomy, and early detection of breast and ovarian cancers, have afforded women with identifiable BRCA1 and BRCA2 mutations the opportunities to significantly lower their risks of developing cancer.6–8 Thus, a strong rationale for counseling high-risk patients to receive genetic testing for mutations in BRCA1 and BRCA2 now exists. With the recent launch of a television and magazine advertising campaign by a major company to market genetic tests to consumers, the cancer community must prepare for the impact of direct-to-consumer (DTC) marketing of genetic tests. To examine the relative merits of DTC marketing of genetic testing, we can extrapolate information from experience with DTC marketing of prescription drugs, already in practice for more than 2 decades. Advocates for such marketing argue that these types of advertisements benefit both patients and their health care providers.9 There are data that suggest that DTC marketing of prescription drugs increases compliance.10,11 In addition, because DTC marketing of prescription drugs must include the phrase "talk with your doctor," there may be facilitation of physician-patient communication.12 It is conceivable, therefore, that DTC marketing of genetic testing may also open a dialogue about cancer risk and genetic testing. At a time when patients seek out information from a variety of sources, it is important to acknowledge that advertising is one vehicle for information delivery. How health care providers react to this opportunity to educate their patients on the role of genetics in the clinic will largely depend on their level of preparedness. DTC marketing of genetic testing might benefit people in novel ways. If advertisements discuss risk in relation to family history, they may be inclined to seek out their own family history in greater detail, prompting discussion about the ramifications of genetic testing on the family unit and raising awareness about the role of genetics. Currently, there is underutilization of genetic counseling, especially in patients with a prior malignancy. It is conceivable that if more cancer patients are aware of the possibility of genetic testing to quantify their risks of second cancers, more of them will likely pursue cancer risk assessment and obtain indicated genetic tests. To that end, DTC marketing of genetic tests could be beneficial. Given the number of possible benefits of DTC marketing of genetic tests, there are also serious concerns. Advertisements for genetic testing are less well-regulated than advertisements for prescription drugs. Both the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) share responsibility for the regulation of advertisements of health products and services, including pharmaceuticals, medical devices, and dietary supplements. Monitoring advertisements for genetic tests is also within the purview of the FDA and the FTC, but unlike prescription medications, there are no clear-cut guidelines for what must be included or explained in advertisements for genetic testing.13 Arguably, genetic testing is a much more complex "product" than prescription drugs, with a variety of associated medical, legal, and psychosocial risks. Currently, the FDA is understaffed and underfunded, resulting in difficulty overseeing the compliance of existing advertising requirements. Pharmaceutical companies have been cited for violating existing regulations, charged with the oversimplification of drug risks and indications, and overstatement of drug benefits.14,15 There is, therefore, concern that there will be a similar simplification of the risks and benefits of genetic testing. Many professional organizations, including the American Society of Clinical Oncology (ASCO), have raised concerns regarding the variability and lack of uniform regulation of the laboratories in which genetic tests are performed. At a national level, the Clinical Laboratory Improvement Act of 1988 regulates laboratories, but these regulations provide minimal and insufficient oversight.16 ASCO advocates that laboratories that deal with cytogenetics and molecular diagnostics invite organizations such as the College of American Pathologists or the American College of Medical Genetics to oversee quality assurance and quality control. Just as it is difficult for the individual practitioner to know the reliability of a laboratory, it will be even more difficult for the consumer. ASCO has also advocated for proficiency testing and data reporting on the limits of genetic tests, such as sensitivity and specificity.17,18 To date, there are no laws mandating this type of reporting, and it is up to the individual laboratory to provide such information. DTC marketing of genetic testing also challenges one of the most fundamental components of genetic counseling: careful patient selection. Currently, there are no genetic tests approved for general screening of the population, and it is the general population who are exposed to DTC marketing.17,18 It is very difficult, therefore, to expect individuals to decide if they are suitable for genetic testing, given the limited information that they receive through an advertisement. It is especially difficult to expect them to make an accurate assessment of their risk when the advertisements build a strong case for testing based on fear and ignorance of both epidemiology and risk assessment tools. In addition to patient selection, formal genetic counseling emphasizes education, informed consent, and pre- and posttest sessions to help the patient understand both the risks and benefits of genetic testing. If DTC marketing of genetic tests provides testing for inherited disorders outside of specialized centers, there is no guarantee that either the consumer or their health care provider will accurately interpret the results. If a person orders a test through a commercial laboratory, there is no guarantee that the commercial laboratory will require informed consent or provide appropriate education and support. In addition, even if health care providers are diligent in keeping current with genetic medicine, the interpretation of the results of genetic testing is often complex.13,18 Simply put, positive tests do not always mean that an individual will develop cancer, and negative tests are not a guarantee that they will remain cancer-free. There are complexities such as missed genes, polymorphisms, low penetrance genes, and sporadic mutations that factor into the interpretation of genetic tests and cancer risk. In fact, a major limitation of genetic testing for common cancers is the number of negative or inconclusive results, leaving consumers and their physicians frustrated. DTC marketing of genetic testing also produces special concerns for physicians involved in patient care. As many physicians have experienced with DTC marketing of prescription drugs, discussions about advertisements can be very time consuming.19 There is no possibility that a 15-minute office visit is adequate to address all of the issues surrounding genetic testing. There is also a paucity of genetic experts, and if the demand for genetic testing increases significantly, it will strain the resources of the entire medical community. An additional concern is that physicians might feel pressured to order genetic tests that are not indicated, as some physicians are susceptible to patient pressure when prescribing medications.13,19–22 In addition, DTC marketing may provide genetic testing to individuals who might otherwise be involved in testing and treatment in the setting of clinical trials, which may ultimately make it more difficult and prolonged to identify better interventions and to create evidence-based standards of care. DTC marketing of genetic tests also raises concerns about matters of public policy. Although a recent review has failed to document insurance discrimination, loss of insurance coverage based on genetic profiles remains a serious concern for patients and health care providers.23–26 DTC marketing of genetic testing also forces us to revisit the issue of confidentiality and mandatory versus voluntary reporting of genetic information to family members. Although ASCO currently endorses the notion that patients should be encouraged to inform family members of pertinent genetic information, it is unknown if this type of informal disclosure is adequate. As genetic testing becomes more prevalent, existing policies are likely to be challenged and reshaped. Finally, there is the concern regarding cost and access to genetic tests. The BRCAnalysis test for breast and ovarian cancer costs approximately $2,700, and is not currently covered by all third-party payers with millions of uninsured or underinsured Americans. Follow-up care and treatment must also be considered, and this type of cost analysis is not available for genetic testing for oncologic disorders. DTC marketing of genetic tests creates new opportunities and challenges for both individuals and their health care providers. In response to these new opportunities, it is imperative that genetic counseling and genetic testing be developed in a responsible manner. There should be guidelines for the advertisements for genetic testing and for the laboratories that provide them. Genetic testing should be offered after a comprehensive cancer risk assessment using current guidelines established by professional groups such as ASCO.27,28 People undergoing genetic testing should have access to extensive pre- and posttest counseling. Centers performing genetic testing should provide patients with the necessary education about how to use test results, and provide psychological support and options for further medical care. To ensure that genetic testing is done in a responsible manner, it is important that the public and the medical community learn more about genetics and cancer. ASCO has developed educational opportunities to aid health care providers in this endeavor, and readers are encouraged to visit the ASCO Web site for further information (http://www.asco.org).17,18,22 Finally, patients are encouraged to obtain testing in an environment that offers longitudinal follow-up. It is only through further research and improved regulatory oversight that we will be able to firmly establish the clinical utility of genetic tests for cancer. REFERENCES 1. Myriad Genetics Television Advertisement Campaign in Atlanta and Denver markets, October, 2002. http://www.myriad.com/media/tv_brac.mpg
2. Huang AJ: The rise of direct-to-consumer advertising of prescription drugs in the United States. JAMA 284:2240, 2000
3. Holmer A: Direct-to-consumer prescription drug advertising builds bridges between patients and physicians. JAMA 281:380–382, 1999
4. Holmer A: Direct-to-consumer advertising: Strengthening our health care system. N Engl J Med 346:526–528, 2002
5. Newman L: Avalanche of direct-to-consumer drug marketing brings new questions. J Natl Cancer Inst 92:964, 2000
6. Gollust S: Limitations of direct-to-consumer advertising for clinical genetic testing. JAMA 288:1762, 2002 7. Claus EB, Schildkraut JM, Thompson WD, et al: The genetic attributable risk of breast and ovarian cancer. Cancer 77:2318–2324, 1996[CrossRef][Medline] 8. Ford D, Easton DF, Stratton M, et al: Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families. Am J Hum Genet 62:676–689, 1998[CrossRef][Medline]
9. Struewing JP, Hartge P, Wacholder S, et al: The risk of cancer associated with specific mutations of BRCA1 and BRCA2 among Ashkenazi Jews. N Engl J Med 336:1401–1408, 1997 10. Thorlacius S, Streuwing JP, Harge P, et al: Population-based study of risk of breast cancer in carriers of BRCA2 mutation. Lancet 352:1337–1339, 1998[CrossRef][Medline]
11. Meijers-Heijboer H, van Geel B, van Putten WLJ, et al: Breast cancer after prophylactic bilateral mastectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med 345:159–163, 2001
12. Kauff N, Satagopan J, Robson M, et al: Risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med 346:1609–1615, 2002
13. Rebbeck T, Lynch H, Neuhausen S, et al: Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med 346:1616–1622, 2002
14. Wolfe S: Direct-to-consumer advertising: Education or emotion promotion? N Engl J Med 346:524, 2002
15. Fintor L: Direct-to-consumer marketing: How has it fared? J Natl Cancer Inst 94:329, 2002 16. CLIA Program: Clinical Laboratory Improvement Amendments. http://cms.hhs.gov/clia/ 17. Statement of the American Society of Clinical Oncology: Genetic testing for cancer susceptibility, adopted on February 20, 1996. J Clin Oncol 1730–1736, 1996
18. American Society of Clinical Oncology: Resource document for curriculum development in cancer genetics education. J Clin Oncol 15:2157–2169, 1997
19. Rosenthal M: Promotion of prescription drugs to consumers. N Engl J Med 346:498, 2002
20. Mintez B: Influence of direct to consumer pharmaceutical advertising and patients’ request on prescribing decisions: Two site cross sectional survey. BMJ 324:278, 2002
21. Hollon M: Direct-to-consumer marketing of prescription drugs: Creating consumer demand. JAMA 281:382, 1999 22. FDA preliminary results of physician survey on direct-to-consumer prescription drug advertisements, January 13, 2003. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01189.html 23. Kolata G: Advent of testing for breast cancer genes leads to fears of disclosure and discrimination. New York Times (print), Feb 4, 1997:C1, C3
24. Matloff ET, Shappell H, Brierley K, et al: What would you do? Specialists’ perspectives on cancer genetic testing, prophylactic surgery, and insurance discrimination. J Clin Oncol 18:2484–2492, 2000
25. Peterson EA, Milliron KJ, Lewis KE, et al: Health insurance and discrimination concerns and BRCA1/2 testing in a clinic population. Cancer Epidemiol Biomarkers Prev 11:79–87, 2002 26. Hall M, Rich S: Genetic Information and Health Insurance. Am J Hum Genet 66:293–307, 2000[CrossRef][Medline] 27. ASCO Curriculum: Cancer Genetics & Cancer Predispostion Testing. ISBN 0-9664495-0-9. Library of Congress catalogue Card Number: 98-73147. http://webapp.asco.org/eSeries/source/Orders/index.cfm?task=3&CATEGORY=CURR&PRODUCT_TYPE=SALES&SKU=CGC001&DESCRIPTION=Curriculum%20Series&FindSpec=&CFTOKEN=59580871&continue=1& SEARCH_TYPE=find&Findln= This article has been cited by other articles:
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Copyright © 2003 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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