FDA Panel Says Home Gene Tests Need Doctor Input


Genetic testing companies believe it is an individual's right to have full access to their health information, while others who testified at the meeting felt that having too much medical information can be harmful, particularly if the information is incorrect, or if there's not much a person could do with the information.

Jeremy Gruber, president of the Council for Responsible Genetics, a nonprofit organization founded to stimulate public debate on the social and ethical impacts of genetic technologies, said he thinks the FDA should better regulate DTC genetic testing companies in order to mitigate the harm that could be caused by the tests.

"We believe that everyone should have access to their genome and allowed to sequence it if they choose," said Gruber. However, he added, "We must acknowledge that DTC testing can cause as much harm as good."

Tests Reveal Little, Boost Anxiety

Many people argue that knowing genetic predisposition to a certain disease -- particularly one for which there is no treatment, such as Alzheimer's -- adds no value and only serves to increase anxiety.

However, that finding was disputed in a recent study published in the New England Journal of Medicine that found users of the at-home genetic tests did not have increased anxiety after their results were revealed.

"The bottom line from actual studies, is that when people attempt to learn something, they are not upset by what they learn, even when the news is bad," said Mary Pendergast, a lawyer, industry consultant, and former FDA deputy commissioner. "Everyone's lives have trials and tribulations. We can handle it."

The panelists -- about half of whom were medical doctors -- also questioned whether average consumers are sophisticated enough to understand their genome screening results, which is part of the reason a physician could be helpful. (However, most physicians aren't trained geneticists, so they can't be expected to be able to accurately interpret the results either, a few committee members pointed out.)

But representatives from the companies that make the tests disagreed with the unsophisticated consumer argument and argued that people deserve to be able to have unfettered access their genetic information.

Pendergast -- who delivered sharply worded testimony during the public hearing that elicited scattered applause from the audience -- accused the panel, and doctors in general, of being "paternalistic."

"The medical profession has objected every time the FDA has tried to give tests directly to consumers," she said, providing home pregnancy tests as an example. "It's, frankly, medical paternalism -- the FDA trying to keep medical products from consumers 'for their own good.'"

The panel also heard from witnesses who referenced a 2010 undercover investigation by the Government Accountability Office (GAO), which revealed that home genetic tests often provide incomplete or misleading information to consumers. For the GAO investigation, investigators purchased 10 tests each from four different direct-to-consumer genetic testing companies -- 23andMe, deCode Genetics, Pathway Genomics, and Navigenics -- and the interpretation of the results differed according to which company analyzed the results.

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