Role of direct-to-consumer ads for genetic tests

Do tests hold emotional appeal for patients?

Many genetic tests advertised directly to consumers are "home brews" that are neither regulated by the U.S. Food and Drug Administration (FDA), nor clinically valid, according to findings by a Boston obstetrics/gynecology specialist.

Erin Tracy, MD, MPH, a physician with Massachusetts General Hospital's OB/GYN Service, says direct-to-consumer advertising for commercial genetic testing is on the rise and may be problematic, because it's poorly regulated and may present potential pitfalls for patients and physicians.

"Some of the tests that are being offered have no proven clinical validity whatsoever and are quite costly," says Tracy, who published her findings in December 2007.1 "So patients spend money trying to identify a particular gene to figure out if their child is prone to addictive behavior, for example.

"If the test comes back positive, parents are often not adequately counseled as to what those results might mean, whether these tests have any proven value, or what resources are available for follow up."

While the FDA might need more funding to regulate genetic testing, Tracy says, it also is limited in its ability to regulate services based in other countries. According to a 2002 study in Genetics in Medicine, 24 of 105 web sites offering genetic testing directed potential clients to international mailing addresses, she says, and many web sites listed professional societies or accrediting organizations on their pages, implying sponsorship or approval of their activities that may not be accurate.

Like other direct-to-consumer ads, these materials do not need to be reviewed by the FDA before they are published, Tracy says. Many involve emotional appeals — such as placing an ad for a cancer-associated gene test in the program of a play about a woman dying from ovarian cancer — instead of clear discussion of the rationale for screening. Results of genetic tests have the potential to cause excessive alarm or to falsely assure consumers that they will not develop cancer or disease, she says, and direct-to-consumer advertising for genetic tests may also give the erroneous impression that a certain test is mandatory preventive medicine.

"Some patients with no risk factors for breast cancer come in and request the test for BRCA-1 and BRCA-2 mutations," says Tracy — requests sparked by a recent advertising campaign. "The ads are compelling and they're emotionally driven. I end up spending time discussing why a particular test being advertised is not appropriate when I should be addressing important issues such as eating a healthy diet or smoking cessation."

At the same time, she notes, without proper counseling a patient who does not have the BRCA-1 or BRCA-2 mutations might assume she has no risk for breast cancer and forgo recommended mammograms and clinical breast examinations.

Patients who inquire about genetic testing should be engaged by their physicians in conversations about their particular risk for cancer or other diseases, Tracy suggests.

"Before any test is ordered, there should be a thought process about whether that particular test is appropriate and what we'll do with [the results]," she adds. "And physicians need to stay current about what's out there so we can best advise our patients."


For more information, contact:

  • Erin Tracy, MD, MPH, Vincent OB/GYN Service. Massachusetts General Hospital, 55 Fruit Street, YAW 4, Boston, MA 02114. Phone: (617) 724-6850.
  1. Tracy EE. Are doctors prepared for direct-to-consumer advertising of genetics tests? Obstet Gynecol 2007;110:1389-1391