Cases in Genetics: Direct-to-Consumer Marketing for Genetic Testing

September-October 2003

This is the fifth of six case studies, prepared for Health Progress by the staff of CHA's Theology and Ethics Department. The final study will be published in the November-December issue.

Your facility has a strong and aggressive oncology program and offers genetic testing for various types of cancer, including breast and ovarian cancer. Recently, both the medical director of the oncology program and the chair of the obstetrics-gynecology department were contacted by a company we will call "GenTest." GenTest researchers discovered BRCA1 and BRCA2, the genes that cause hereditary breast and ovarian cancer. Approximately 5 to 10 percent of breast cancer cases are caused by hereditary factors. GenTest offers clinical tests to determine predisposition to these and other cancers.*

* BRCA1 and BRCA2 are tumor suppressor genes; that is, they prevent cells from dividing in an uncontrolled manner. A woman with an inherited mutation of either gene has an approximately 85 percent risk of developing breast cancer during her lifetime. Mutations of BRCA1 also increase the lifetime risk of developing ovarian cancer by 45 to 60 percent. Hence a positive test result indicates a predisposition to breast and/or ovarian cancer, but does not guarantee that the individual will, in fact, develop either.

On the other hand, a negative test result does not mean that the woman will not develop breast and/or ovarian cancer. A previous family history of breast and/or ovarian cancer and ethnic background (Eastern European and Ashkenazi Jews) are two indications that testing for BRCA1 and BRCA2 might be appropriate. A full genetic test costs more than $2,700.

GenTest has begun direct-to-consumer marketing of genetic testing for predisposition to breast and ovarian cancer.† The company spent several million dollars to run commercials advertising its services on TV shows that are popular with women. It also took out ads in two popular women's magazines. In two large U.S. cities, women were targeted by an advertising campaign that asked: "Concerned about breast cancer? We offer a genetic test that shows whether you have a mutation that increases your risk."

† A company offering services similar to those of our fictional GenTest is described in "Gene Test Ads Prompt Concern," Boston Globe, March 26, 2003.

GenTest considers its campaign successful. Its 800 line received a large number of calls from residents of the two cities. The company also saw a tenfold increase in its website hits. Its officers believe that this marketing has indeed raised awareness. In light of this success, GenTest now wants to expand its markets and diversify its marketing vehicles to include newspaper ads, billboards, and brochures for placement in doctors' offices and hospital waiting rooms.

GenTest has invited your oncology program and ob-gyn department, as well as others in the community that offer predisposition testing, to partner with it. More specifically, the firm's representatives wish to include in its new ads the names of those hospitals in the community that offer testing for BRCA1 and BRCA2. The blood samples would, of course, be sent to GenTest for analysis and the results would be sent back to the individual's physician.

Should your facility participate in this direct-to-consumer marketing campaign for predisposition genetic testing for BRCA1 and BRCA2?

Questions for the Board
Would you advise that the hospital participate in this direct-to-consumer marketing effort?

What considerations would enter into your decision? What would be the decisive considerations?

How, specifically, would you take into account the mission and values of the organization? How would you balance these considerations with others that have surfaced (that is, what weight would they have)?

Questions for Executive Management
Do you believe that your organization should participate in this direct-to-consumer marketing effort?

What considerations would enter into your decision? What would be the decisive considerations? Why would they be decisive?

How, specifically, would you take into account the mission and values of the organization? How would you balance these considerations with others that have surfaced (that is, what weight would they have)?

If your organization currently does testing for BRCA1 and BRCA2, is there any policy in place that speaks to who is an appropriate candidate for testing, or do you accept anyone who wishes to be tested? If you do not screen for appropriateness, is this an adequate approach? If you do screen, why is that the case? Does such an approach fit the values of the organization and the guiding values of Catholic health care?

Questions for the Ethics Committee
What do you see as the ethical issues in this case?

What values/moral principles have a bearing on each of these issues?

How would you address each of the ethical issues involved?

What would be your recommendation to the CEO regarding the organization's participation in this marketing effort? What would be your ethical rationale?

If your organization does BRCA1 and BRCA2 testing, does it have a policy regarding who is an appropriate candidate for testing? If there is no such policy, what do you think might be a good policy? Why? Do you think adolescents should be tested? If so, should they be told of the test results?

How does your organization decide what is and what is not appropriate marketing? Are there any guidelines or criteria for making these decisions? If there are guidelines, are they adequate? If there are none, what would you suggest?

Guiding Ethical Principles
The following principles are intended to provide some moral guidance to discussions of the questions above. They are not exhaustive of the principles that might be relevant to the case and to the various questions raised. They should, however, be of some help. These principles are drawn and adapted from the Ethical and Religious Directives for Catholic Health Care Services, the Catholic moral tradition, the social teaching of the church, and secular bioethics.

A statement of the mission and values of the organization should play a central role in these discussions as well.

  • Veracity Communication between and among individuals and organizations should be truthful and should avoid being misleading or manipulative. In this light, health care advertising should be truthful, fair, accurate, and complete. It should address genuine health care needs, foster the appropriate use of therapeutic modalities, promote realistic expectations, avoid manipulating desires, and contribute to the well-being of patients.
  • Professionalism The provider-patient relationship is professional in nature and therefore implies a fiduciary responsibility to those being served; that is, the well-being of those being served takes precedence over the interests of health professionals and health organizations. The professional responsibility of clinicians and health care organizations also requires that patients are provided only care that is needed and beneficial.
  • Respect Human Dignity Because we believe that each person is made in the image and likeness of God, we ought to treat others with profound respect and utmost regard.
  • Beneficence Our decisions and actions ought to contribute to the well-being of others.
  • Nonmaleficence Our decisions and actions should not harm others.
  • Informed Consent When making decisions about possible diagnostic or therapeutic modalities, individuals should have adequate and accurate information and understanding of the nature of the modality, its risks, benefits, and burdens (as well as information about and understanding of the alternatives to that modality) and should make the decision about its use freely—that is, without force, coercion, or manipulation.
  • Stewardship Health care resources should be delivered and used prudently, efficiently, effectively, equitably, and in a manner that reflects professional standards of quality. Providing unnecessary services is a violation of good stewardship.
  • Solidarity Because we are made in the image of a triune God, we are social by nature. This fundamental relatedness with others implies responsibilities to them. At minimum, we should not harm them. Optimally, we ought to seek their good.
  • Distributive Justice Societal goods and resources should be distributed equitably.
  • Common Good Because of our social nature, we ought to contribute to the creation of "conditions of social life by which individuals, families, and groups can achieve their own fulfillment in a relatively thorough and ready way" (The Church in the Modern World, section 74). In this light, health care organizations ought to contribute to the public good, in part by seeking to improve the health status of the community.


Barnes-Keaton, I. M. and Plan, S. E., "Counseling the At Risk Patient in the BRCA1 and BRCA2 Era," 7bstetrics and Gynecological Clinics of North America, vol. 29, June 2002, pp. 341-366.

Bove, Catherine M., Fry, Sara T., and McDonald, Deborah J., "Presymptomatic and Predisposition Genetic Testing: Ethical and Social Considerations," Seminars in Oncology Nursing, vol. 13, no. 2, May 1997, pp. 135-140.

Greggi, S., Scala, F., and Laurelli, G., "Hereditary Breast and Ovarian Cancer," Current Problems in Cancer, vol. 27, January-February 2002, pp. 24-28.

Hall, Robert T., "Advertising and Marketing," in An Introduction to Healthcare Organizational Ethics, Oxford University Press, New York City, 2000, pp. 59-76.

Michner, Chad, et al., "Genomics and Proteomics: Application of Novel Technology to Early Detection and Prevention of Cancer," Cancer Detection and Prevention, vol. 26, no.4, 2002, pp. 249-255.

National Association of Genetic Counselors, "Predisposition Genetic Testing for Late-Onset Disorders in Adults," JAMA, vol. 278, no.15, October 15, 1997, pp. 1,217-1,219.

Onyango, Patrick, "Genomics and Cancer," Current Opinion in Oncology, vol. 14, no. 1, 2002, pp. 79-85.

Weber, Leonard J., "Responsible Advertising," in Business Ethics in Healthcare, Indiana University Press, Bloomington, IN, 2001, pp.121-129.

Wooster, R., and Weber, B. L., "Breast and Ovarian Cancer," New England Journal of Medicine, vol. 348, June 5, 2003, pp. 2,339-2,347.


Copyright © 2003 by the Catholic Health Association of the United States
For reprint permission, contact Betty Crosby or call (314) 253-3477.

Cases in Genetics - Direct-to-Consumer Marketing for Genetic Testing

Copyright © 2003 by the Catholic Health Association of the United States

For reprint permission, contact Betty Crosby or call (314) 253-3490.