Direct-to-consumer advertising for
genetic tests concerns physicians and may mislead patients
BOSTON - November 30, 2007 - 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
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, the MGH 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.
Media Contacts: Valerie
Wencis , MGH Public Affairs
Physician Referral Service: 1-800-388-4644
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