Direct-to-consumer advertising for commercial genetic testing is on the rise and may be problematic, according to a Massachusetts General Hospital (MGH) physician. In the December issue of Obstetrics & Gynecology, Erin Tracy, MD, MPH, warns that such testing is 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. "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."
The majority of DNA tests are "home brews" that are unregulated by the FDA, Tracy explains. While the FDA needs more funding to regulate genetic testing, 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. Many 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. 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. Direct-to-consumer advertising for genetic tests may also give the erroneous impression that a certain test is mandatory.
"Some patients with no risk factors for breast cancer come in and request the test for BRCA-1 and BRCA-2 mutations," says Tracy, referring to 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.
In order to make an informed decision about genetic tests, patients should consult with their physicians about their particular risk for cancer or other diseases, Tracy says. "Before any test is ordered, there should be a thought process about whether that particular test is appropriate and what we'll do with it. And physicians need to stay current about what's out there so we can best advise our patients."
Founded in 1811, Massachusetts General Hospital is the third oldest general hospital in the United States and the oldest and largest in New England. The 900-bed medical center offers sophisticated diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. Each year the MGH admits more than 46,000 inpatients and handles nearly 1.5 million outpatient visits at its main campus and health centers. Its Emergency Department records nearly 80,000 visits annually. The surgical staff performs more than 35,000 operations and the MGH Vincent Obstetrics Service delivers more than 3,500 babies each year. The MGH conducts the largest hospital-based research program in the country, with an annual research budget of more than $500 million. It is the oldest and largest teaching hospital of Harvard Medical School, where nearly all MGH staff physicians serve on the faculty. The MGH is consistently ranked among the nation's top hospitals by US News and World Report.