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Consumers who buy genetic tests in hopes of seeing what diseases they are likely to contract may be misled, according to a report from the U.S. Government Accountability Office. In addition, the results can vary so widely that they are “of little or no practical use,” the report concludes.

Congress and the U.S. Food and Drug Administration are trying to regulate this nascent but burgeoning field even amid uncertainty over the meaning of test results that indicate someone has genetic risks for certain diseases. “The problem with these marketing practices is that it is not clear today whether the exciting scientific developments in human genetics research actually transfer into ways to improve and individualize health care,” Rep. Henry Waxman (D-CA) said Thursday at a congressional hearing on the industry.

The most shocking findings from the GAO report come from a series of undercover phone calls made to 15 genetic testing companies. Fictitious consumers asked about test reliability, privacy policies, and sales of nutritional supplements or other products tailored to an individual’s DNA. In the phone calls, people who sound like telemarketers are heard giving unsubstantiated and sometimes nonsensical medical advice. For example, at least four companies “claimed that a consumer’s DNA could be used to create personalized supplements to cure disease,” according to the GAO. Two companies condoned the “potentially illegal practice of testing DNA without prior consent.” Overall, the GAO found, 10 of the 15 companies engaged in fraudulent or deceptive marketing.

Both congressional leaders and company representatives said they were dismayed after hearing the calls. However, lawmakers and the companies maintained that genetic testing has a strong potential future in medicine, and that it would be unfortunate if snake-oil salesmen stained the entire industry.

This new level of federal scrutiny follows three years of minimal regulation for direct-to-consumer genetic testing. Several testing companies sprung up around three or four years ago to take advantage of rapidly expanding knowledge of how human genetics can be linked to diseases such as diabetes and cancer. The tests, which can be ordered over the Internet and range from about $100 to $1,000, typically analyze a person’s genome for common genetic variations that have been linked to a relatively minor increased risk for a particular disease.

The industry has been under fire since its inception, as physicians and scientists question whether this information about modest risks can truly be used to make health-care decisions. Complicating matters further are claims from many of these companies that they are not providing a medical service and therefore do not require regulation from the FDA, even though many of their marketing materials allude to the promise of better health.

To evaluate direct-to-consumer genetic testing, the GAO sent DNA samples from five donors to four companies–23andMe, Navigenics, Pathway Genomics, and DeCode–for testing. These four are “touted as the most reputable in the industry,” said Gregory Kutz, managing director of Forensic Audits and Special Investigations at the GAO. For each of the donors, one sample used factual information, while the second had fake age and ethnicity information. GAO investigators then made undercover calls to the companies to discuss the results.

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Tagged: Biomedicine, genetic testing, FDA, genetic tests

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