The Genetics and Public Policy Center is an independent and objective source of information and analysis on genetic technologies and policies.
The Genetics and Public Policy Center is funded through a grant from The Pew Charitable Trusts and is part of The Phoebe R. Berman Bioethics Institute at Johns Hopkins University.
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Editor: Shawna Williams
If you think this is already possible, that may be because you’ve read ads for companies such as Sciona, Genelex, and Suracell. But according to a recently-released report by the Government Accountability Office (GAO), some companies “mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers.”
The report was commissioned last year by the Senate Special Committee on Aging to investigate the growing phenomenon of direct-to-consumer (DTC) genetic tests. The investigation followed the Center’s GenePOPS forum on DTC in May 2005. The GAO focused specifically on Web sites claiming their tests would analyze genes “to create personalized dietary and other lifestyle-related recommendations;” but not to detect disease or predisposition to disease. These are known as nutrigenetic tests. According to experts consulted by the GAO, while some diseases have been linked definitively to mutations in specific genes, “none of the predictions contained in any of the results [GAO] received can be medically proven at this time.”
These findings were presented by Gregory Kutz of the GAO at a hearing of the Committee on July 27, titled “At Home DNA Tests: Marketing Scam or Medical Breakthrough?”. Center Director Kathy Hudson also testified at the hearing, along with witnesses from nutrigenetic testing companies, the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA).
Committee Chairman Gordon Smith (R-OR) opened the hearing by stating that “genetic science holds great promise, and with that promise, a hope for a better understanding of human health and disease.” However, he said, “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.” A press release issued by Smith’s office and released at the hearing likened at-home genetic tests to modern-day “snake oil.”
Kutz, the managing director of forensic audits and special investigations at the GAO, then testified about the methods and findings of the investigation. DNA from one female and one male was sent to four different companies offering nutrigenetic testing over the Web. The samples were accompanied by fictitious profiles indicating the DNA belonged to people of various ages, genders, sizes, and habits.
Despite the fact that all four Web sites state that their tests are not intended to diagnose disease or predisposition to disease, all sent back results warning that the fictitious customers were at risk for a range of medical conditions, including type 2 diabetes, osteoporosis, cancer, heart disease, and brain aging. These predictions appeared to be independent of which DNA sample was sent in, even though the female and male test results showed different gene variants.
Along with these frightening reports, Kutz testified, several of the companies sent recommendations for “personalized” dietary supplements. In one case the same supplement (sold by the company marketing the test) was recommended to three fictitious customers with different profiles and gene variants. The supplement cost approximately $1,200 for a year supply, but the GAO found it contained the same ingredients (in different proportions) as a generic multivitamin retailing for $35 a year. Another company recommended a supposedly personalized regimen of supplements costing over $1,880 annually. These included tablets purported to “promote DNA repair,” although “no pill has yet been proven to repair damaged DNA,” the GAO maintained.
The GAO also received contradictory genetic test results when it submitted two samples from the same person to one company. The laboratory conducting tests for another of the companies was not approved under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), although such certification is required.
Center Director Kathy Hudson testified after Kutz, and focused on the need to fill in current regulatory gaps around genetic testing. Without external scrutiny of genetic tests and testing laboratories, physicians and the public have little assurance that the tests they use to make profound medical decisions are reliable and relevant predictors of their disease risk or treatment outcome, she said. Asked by Sen. Smith whether home genetic tests are ever appropriate, Hudson answered, “If sufficient regulations were in place to ensure the analytic validity of tests and the clinical validity of tests, I think then we could really have a conversation about whether or not it’s appropriate for consumers to access some tests directly - All genetic tests are not created equal so we need to have a nuanced approach to whether a healthcare provider’s intervention is required always, sometimes, or never.”
Next to testify were representatives of the companies investigated in the report. Each spoke about their company’s history and products, and each said they welcomed the prospect of more stringent regulation of genetic testing. Smith asked several of the company representatives about specific concerns raised by the report. “I’m very worried that consumers are being preyed upon,” he said.
The final witnesses were Steven Gutman of the FDA and Thomas Hamilton of CMS. Gutman testified that the FDA plans to work “to address concerns about Internet sale of genetic tests directly to consumers.” Asked whether the agency should have authority to regulate so-called homebrew tests – an issue it had been unclear on – Gutman replied, “Yes, sir, I believe that we should. I actually believe that we do.”
Hamilton detailed his agency’s enforcement of standards established under the CLIA, but said that CLIA only covers the analytical validity of tests – their accuracy – not other issues such as the clinical value of tests or advertising claims made about them. When Smith asked what he thought of the tests subject to the investigation, Hamilton replied, “I’ve found the kind of statements that are so vague and apply to so many people that it might amount to no more than a genetic horoscope.
Smith told Gutman and Hamilton that the Committee will follow up to ensure their agencies better prevent potentially fraudulent DTC business practices. He concluded, “Let’s put the regulatory structures in place so that the American people are protected and the promise of genetics is not damaged by some who would take advantage of unsuspecting American consumers.”
On the day of the hearing the Federal Trade Commission, the FDA, and the Centers for Disease Control released a consumer alert about at home genetic tests. “Some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation,” the advisory states. “Be wary of claims about the benefits these products supposedly offer.”
Summary of the Senate Hearing (Including video feed)
Kathy Hudson’s Testimony Before the Senate Special Committee on Aging
The Federal Trade Commission’s Advisory on At-home Genetic Tests
Read our Issue Brief on Genetic Testing Quality Initiative
Read our Issue Brief on Direct-to-Consumer Genetic Testing
GPPC Event: “Direct-To-Consumer Genetic Testing: Medicine and the Marketplace”
Center in the News: Direct-to-Consumer Genetic Testing
The recent debate on the Senate floor was politics as usual for stem cell policy. As in past debates, the rhetoric was characterized by polarization and declarations of a moral divide in the Senate and the country. Fourteen months after the House of Representatives passed the Stem Cell Research Enhancement Act of 2005, Senate Majority Leader Bill Frist scheduled a 12-hour floor debate on July 17 and 18 on the bill and two other bills relating to stem cell research.
As part of the Center’s efforts to highlight the need for better government regulation of genetic testing, Law and Policy Director Gail Javitt has taken on the case of a test that claims to determine fetal sex as early as five weeks into pregnancy. In an article entitled “Pink or Blue? The Need for Regulation is Black and White,” published in the July 2006 issue of the journal Fertility and Sterility, Javitt cinches the case that the time for the government to take action is now.
Kim Frye is the Center’s new Assistant to the Director. She handles all administrative and research support for Kathy Hudson and Joan Scott, manages Hudson's calendar and assists in the coordination of Center events. Prior to coming to GPPC, Frye worked as a special education teacher and managed a chiropractic/physical therapy clinic. She holds a B.A. in Social Services from George Mason University.
Shawna Williams recently joined the Center as its Science Writer / Managing Editor. She writes about the Center's research and activities for the public. Previously, Williams was the public affairs officer at the Boyce Thompson Institute for Plant Research in Ithaca, New York. She has held science writing internships at the Salinas Californian newspaper, the Stanford Linear Accelerator Center, the University of California, Santa Cruz, the European Organization for Nuclear Research (CERN), and the Stanford University Medical Center. Williams holds a B.A. in Biochemistry from Colorado College and a graduate certificate in Science Writing from UC Santa Cruz.
In late July the Center published a new issue brief on its Web site. Titled “Direct-to-Consumer Genetic Testing: Empowering or Endangering the Public?”.