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Smith: At Home DNA Tests -- “Modern Day Snake Oil”
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July 27th, 2006 - Washington, DC – In an effort to warn consumers against misleading direct to consumer (DTC) genetic tests, Chairman Gordon H. Smith (R-OR) convened the Senate Special Committee on Aging to present the findings of a Government Accountability Office (GAO) investigation into companies that are selling DTC genetic tests and the laboratories performing the tests. Chairman Smith called for the year-long GAO investigation in response to rising concerns about minimal oversight of DTC genetic tests and the unproven science behind them.
“Genetic science holds great promise, and with that promise, a hope for a better understanding of human health and disease,” said Chairman Smith. “GAO’s alarming findings, however, indicate that many companies are a fraudulent manifestation of this promise. Clearly consumers are being misled and exploited by this modern day snake oil 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. The goal of this investigation is to spotlight the great deception these companies are perpetrating on the American people and to spur the government into sufficient regulation of this industry.”
In 2004, the HHS Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) defined DTC genetic testing as both advertising of genetic tests and access to testing without the involvement of a health professional. According to Smith, for a few hundred to a few thousand dollars, nearly a dozen companies are marketing “pre-dispositional” genetic tests over the internet for conditions ranging from cancer and blood disorders to nutritional status (nutigenomic tests) and susceptibility to depression. The tests usually require consumers to mail in cells from the mouth, stool or blood for analysis and test results are sent directly to the consumer.
GAO’s major findings from the investigation include:
· DTC nutrigenomic tests are not clinically valid;
· Companies mislead and exploit consumers by making health-related predictions that are medically unproven and so ambiguous that they are meaningless;
· Companies further exploit the consumer by recommending purportedly DNA customized, and costly, supplements; and
· Greater oversight is urgently needed.
Along with testimony from GAO, the Committee heard from Dr. Kathy Hudson, Director, Genetics & Public Policy Center, Johns Hopkins University Berman Bioethics Institute; representatives from the companies included in GAO’s investigation (Sciona, Suracell, Genelex, Genaissance and Genox); the Centers for Medicare and Medicaid Services (CMS); and the Food and Drug Administration.
A web cast of the hearing is available here.
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U.S. Senate Special Committee on Aging
G31 Dirksen Senate Office Building
Washington, DC 20510
Phone: 202-224-5364
Fax: 202-224-8660
mailbox@aging.senate.gov
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