Consumer gene tests “misleading and of little or no practical use” — GAO

Genetic testing services marketed to consumers over the Internet provided results that were “misleading and of little or no practical use,” say investigators from the U.S. Government Accountability Office (GAO), an investigative agency of the U.S. Congress.

In the investigation, the GAO bought ten tests each from four companies that on their websites claimed their tests would help the customers and their doctors detect the risk of disease early so consumers could take steps to prevent those conditions from developing.

At the same time, the companies also said their tests were not meant to give medical advice or to be used to treat or diagnose disease, the GAO investigators noted.

After obtaining the tests from the companyies, the GAO investigators selected five DNA donors and created two profiles for each, one containing factual information about the donor and the other fictitious information about the donor’s medical history, age, race and ethnicity.

They then sent two DNA samples from each donor, collected from saliva or a cheek swab, to each company, one with the donor’s factual history and one with the fictitious history.

The investigators also follow up with undercover telephone calls to the companies seeking medical advice based on the donor’s real and fictitious histories.

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Undercover Contact with Direct-to-Consumer Genetic Testing Companies

Listen to examples of deceptive or dangerous marketing used by genetic testing companies, obtained by GAO through undercover contact and telephone calls.

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The investigators focused on the companies analyses related to 15 common diseases, including: Alzheimer’s disease; a heart beat disorder called atrial fibrillation; breast, prostate and colon cancer, heart attacks; and multiple sclerosis.

The investigators also contacted 9 other companies offering direct-to-consumer genetic testing and, posing as consumers, asked about the reliability and usefulness of their tests and about dietary supplements and other products some of these companies sell.

Findings

The results for each donor varied from company to company.

For example, one donor, a 37-year-old woman, was told her risk of developing breast cancer was average by two of the companies and above average by the other two.

Another donor, a 48-year-old man, was told his risk of prostate cancer was above average by one company, below average by another, and average to the two other companies.

The investigators found similar patterns of contradiction for other conditions as well.  ”Identical DNA samples produced contradictory results,” the GAO investigators write.

When the investigators asked genetics experts if any of one company’s test might be more accurate than the others, they responded that there were “too many uncertainties and ambiguities in this type of testing to rely on any of the results,” the GAO said.

In four out of the five donors, the test results conflicted with the donor’s actual medical condition and family history.

In one case, a donor had type 2 diabetes, but three of the companies reported that he had an average risk of developing the disease.

Another donor had a family history of heart disease, yet all four companies reported her risk was average. A family history of heart disease generally increases your own heart disease risk.

In follow up interviews, representatives from the companies repeated that their tests were not diagnostic but argued the tests were still valuable because they provided consumers and their doctors with useful information.

But genetics experts consulted by the GAO said that most doctors are unprepared to use information derived from this sort of testing and that there is no evidence that such tests lead people to change their lifestyles, the GAO said.

When investigators, posing as consumers, contact 15 direct-to-consumer genetic testing companies, including the 4 to whom DNA samples had been sent, they found that 10 or of the 15 “engaged in some form of fraudulent, deceptive, or otherwise questionable marketing practices,” the GAO said.

These included promoting the company’s dietary supplements as cures for arthritis and other conditions and making such claims as the company’s tests could predict athletic performance and help determine which sports a child would do well in.

Two of the companies claimed their supplements could “repair damaged DNA”, the GAO said.

The GAO called these and other claims made by the companies “egregious examples of deceptive marketing.”

“Although the experts GAO spoke with believe that these tests show promise for the future, they agreed that consumers should not rely on any of the results at this time,” the GAO said.

To learn more:

• Read the GAO report: Direct-To-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices

Tags: GAO, Gene Testing, Government Accountability Office. DNA

Category: Genetics & Birth Defects, Lab Tests & Diagnostics, News, Vitamins & Supplements