In an undercover investigation, GAO purchased a variety of direct-to-consumer genetic tests, which claim to identify which health conditions consumers are at a high risk for. As part of their health package, the marketers of these tests offer ‘personalized’ dietary supplements to help prevent the onset of these conditions.
GAO’s report, which was presented to the US House of Representatives, followed an earlier investigation conducted in 2006. This had prompted the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to warn consumers to be wary of the results of these tests.
However, new – and reportedly more reputable – genetic test companies have since appeared on the market with direct-to-consumer products, prompting the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce to request the current GAO investigation.
GAO purchased 10 tests from each of four companies, which ranged in price from $299 to $999. The agency selected five donors to pose as fictitious consumers, and sent two DNA samples from each donor to each company.
On reception of the results, which provided risk predictions for 15 diseases, GAO made undercover calls to the companies seeking health advice, and also asked the companies about supplement sales. It then consulted with genetic experts to examine the information collated.
On examination of the results, GAO found that different tests yielded different results for the same DNA samples. For example, one fictitious consumer was told that he had below average, average and above average risk for prostate cancer.
Other results were found to conflict with actual medical histories. For example, a consumer with an implanted pacemaker for an irregular heartbeat was told that he was at decreased risk for developing this condition.
GAO’s report reveals that companies claimed a consumer’s DNA could be used to create personalized supplements to cure diseases, and often used fraudulent endorsements from high-profile athletes to encourage purchases. One company charged $145 per month for these personalized supplements, which were blends of vitamins and nutrients.
Although GAO did not test the supplements to verify their contents, the ingredient lists identified compounds such as raspberry juice powder, green tea extract, and garlic powder. Other supplement products were sold with no ingredient lists.
Consumers were told that these products could cure diseases such as arthritis and high cholesterol, or prevent conditions such as high blood pressure.
GAO has briefed FDA, National Institutes of Health and FTC on its findings, and has also referred all the companies it investigated to FDA and FTC for “appropriate action”.
A full copy of the report is available here.