To his credit, Kári Stefánsson, the CEO of deCODE Genetics, didn’t defend the “road-map” line when I asked about it — in fact, he seemed surprised. “I think that is both cheesy and somewhat incorrect. I don’t know who came up with that, but whoever it is, is going to be duly punished,” he said. “I think it’s safe to say we’ll probably be removing that statement and putting up something that at least sounds better.”
The FDA should require DTC companies to post clear disclaimers on their websites, and possibly it should develop criteria as to how DTC companies interpret DNA data for consumers. Many companies, including 23andMe and deCODEme, even support some additional regulations. “I think it’s going to be advantageous for those of us who market these tests that they are regulated,” Stefánsson says. 23andMe is “moving forward to establish the process for FDA authorization of our entire genetic testing platform,” including the information it provides, according to the company’s general counsel, Ashley Gould.
A few overzealous ads, however, are not a reason to force all consumers to seek the government’s permission before sending their own DNA to a private company for testing.
Another common worry is that people may react improperly to the information they’re given. In fact, this just doesn’t seem to be happening: A recent study found that, overwhelmingly, people don’t change their lifestyles in response to their DNA results. And even if people did change their behavior, the odds are pretty good that it would be for the better: A few people might do irrational things like take up smoking on the assumption that they’d die from something else anyway, but most would probably just eat healthier, start a vitamin regimen targeted toward their biggest risks, and exercise more.
WHAT DNA CAN ACCOMPLISH
All of that said, DTC companies allow individuals to track their genealogy, provide information that may in the future become medically relevant, and give researchers a massive collection of data to work with. The FDA needs to preserve Americans’ direct access to these services.
To be clear, the FDA does not claim an authority to regulate DTC testing that’s done for strictly genealogical reasons. However, many companies’ standard services include both medical and genealogical results, and the more thorough tests that are the wave of the future — those that catalogue massive numbers of genetic variations, and those that sequence the entire genome — could fall under the forthcoming regulations.
How much does genetic testing tell a person about his ancestry? Quite a lot, actually. It turns out — contrary to the deafening chorus of “Race is nothing but a social construct” coming out of the academy — that as groups of people evolved in different regions of the globe, they developed distinctive genetic patterns. Now that researchers have figured out which genetic patterns correspond to which ancestries, DTC companies can ascertain, with a high degree of accuracy, where a customer’s bloodlines come from. Certainly, some people find this kind of information more fascinating than others do — but there’s no government interest whatsoever in making such knowledge harder to access, even if it’s packaged with medically relevant facts.
Further, while the medical aspect of DTC testing is of limited value now, that may change soon. Many diseases result from complex interactions between genes and environment, and as geneticists develop more sophisticated tools, they may unravel those interactions — making genetic information that much more valuable.
And it turns out that DTC testing itself is a significant boost to this research; some companies offer their customers the chance to participate in studies. By giving scientists access to their genomes, and by answering survey questions, customers can advance the state of knowledge about genes, disease, and behavior. Thanks to this sense of volunteerism, researchers can access DNA from all over the world without having to collect it themselves. “For our Sarcoma Community,” notes 23andMe’s Gould, “we were able to assemble more than 500 participants in only six months, which would be expensive and nearly impossible to do in traditional research models due to the extremely rare nature of sarcomas.”