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Senior Citizen Alerts
DNA Tests Marketed Online as 'Nutrigenetic Tests'
Are Misleading
Senate aging committee, FTC, FDA, CDC, GAO sound
warnings
July 31, 2006 – Sounds tempting doesn't it – to buy
online a relatively inexpensive do-it-yourself genetic test to do your
own DNA check. Senior citizens, the most vulnerable and concerned about
genetic diseases are clear targets of these marketers. "…consumers now
can purchase at-home tests that claim to predict propensities for a
myriad of health conditions, including Alzheimer’s, cancer, diabetes and
arthritis," according to Sen. Gordon H. Smith, chairman of the Senate's
committee on aging.
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Senior Citizen Alerts |
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Shortly before Smith (R-Oregon) opened a hearing
Thursday by the Senate Special Committee on Aging about the growing
business of direct-to-consumer genetic tests, the Federal Trade
Commission issued a caution saying " The Food and Drug Administration
and the Centers for Disease Control and Prevention say that genetic
tests should be performed in a specialized laboratory, and the results
should be interpreted by a trained health care professional or genetic
counselor."
In prepared remarks, Smith said in opening the
hearing, "I am deeply disturbed by GAO’s finding that consumers are
being misled and exploited. And I am shocked to learn how little the
federal government is doing to help consumers make informed decisions
about the legitimacy of these tests."
Headlining the hearing by the Senate Special
Committee on Aging, Gregory D. Kutz , Managing Director, Forensic Audits
and Special Investigations, U.S. Government Accountability Office,
reported on investigative work by the GAO.
The companies market these tests as "nutrigenetic
tests" and typically stress that the results and information they
provide are not intended to diagnose or treat any disease or disorder,
they do claim that their tests will provide consumers with the
information needed to tailor their diet and exercise programs to address
their genetically determined health risks, Kutz reported.
The GAO purchased tests from four Web sites and
created “fictitious consumers” by submitting for analysis 12 DNA samples
from a female and 2 samples from an unrelated male, and describing this
DNA as coming from adults of various ages, weights, and lifestyle
descriptions.
"The results from all the tests GAO purchased
mislead consumers by making predictions that are medically unproven and
so ambiguous that they do not provide meaningful information to
consumers," according to the report by Kutz.
Sen Smith said, The Washington Post reported in
June that these home tests can "shock and misinform consumers."
The American College of Medical Genetics has
advised the public to avoid home DNA tests, which it has called
“potentially harmful,” citing the possibility of “inappropriate test
utilization, misinterpretation of test results, [and] lack of necessary
follow-up,” according to Smith.
The Federal Trade Commission also announced a new
“Facts for Consumers” on over-the-counter genetic tests. According to
the FTC, some companies claim that their tests can help consumers screen
for diseases, evaluate health risks, or suggest treatments. "At Home
Genetic Tests: A healthy Dose of Skepticism May Be the Best Prescription
is available online-
click here.
The FTC also cautioned that genetic testing
provides only one piece of information about a person’s susceptibility
to disease. Other factors, like family background, medical history, and
environment also contribute to the likelihood of getting a particular
disease.
Consumers should know, according to the FDA and
CDC, that at-home genetic tests are not a suitable substitute for a
medical check-up. However, if a consumer is considering an at-home
genetic test, tips include:
● Talk to your trained health care professional
or genetic counselor about whether it might provide useful information
about your health, and if so, which test would be best. Make sure you
understand the benefits and limits of any test before you buy it – or
take it.
● Ask your trained health care professional or
genetic counselor to help you understand your test results. Most
companies that sell at-home genetic tests do not interpret the results.
● Discuss the results of your test with your
trained health care professional or genetic counselor before making
dietary or other health-related decisions. Genetic test results can be
complex and serious. You don’t want to make any decisions based on
incomplete, inaccurate, or misunderstood information.
● Protect your privacy. At-home test companies
may post patient results online. If the Web site is not secure, your
information may be seen by others. Before you do business with any
company online, check the privacy policy to see how they use your
personal information, and whether they share customer information with
marketers.
Link to
statements and video:
U.S. Senate Special
Committee on Aging
“At Home DNA Tests:
Marketing Scam or Medical Breakthrough?” (July 27, 2006)
Webcast:
Click here to view hearing
> Senator Gordon Smith (Click
here to view statement - PDF)
Witness Testimony
Panel 1
> Gregory D. Kutz , Managing Director, Forensic Audits and Special
Investigations (FSI), U.S. Government Accountability Office
(Click
here to view statement - PDF)
> Dr. Kathy Hudson , Director, Genetics & Public
Policy Center, Johns Hopkins University Berman Bioethics Institute
(Click
here to view statement - PDF)
Panel 2
> Rosalynn Gill-Garrison , Chief Science Officer, Sciona, Boulder, CO
(Click
here to view statement - PDF)
> Carol Reed , VP and Chief Medical Officer,
Genaissance Pharmaceuticals, Newton, MA, with labs in Connecticut and
North Carolina
(Click
here to view statement - PDF)
> Kristopher King , CEO, Suracell, Montclair, NJ
(Click
here to view statement - PDF)
> Rama Rathnam , President, Genox, Baltimore, MD
(Click
here to view statement - PDF)
> Howard Coleman , CEO, Genelex Corporation,
Seattle, WA
(Click
here to view statement - PDF)
Panel 3
> Thomas Hamilton , Director, Survey and Certification Group, Centers
for Medicare and Medicaid Services (CMS)
(Click
here to view statement - PDF)
> Steven M. Gutman , MD, Director, Office of in
Vitro Diagnostic Devices, Food and Drug Administration (FDA)
(Click
here to view statement - PDF)
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