Using a medical device like a DNA kit and relying on companies’, rather than doctors’, interpretations of our unsupervised genetic information from those kits, the FDA said, might lead a patient to undergo unnecessary surgeries to prevent cancer, increase or decrease doses or stop a doctor’s prescriptions and therapy altogether.
By the time I received my 23andMe results, the company had switched to focusing more on ancestry (it told me I am 50 percent East Asian and 50 percent European—no shocker), other traits like eye color (I’m likely to have dark-colored eyes—also duh), whether I can detect taste bitter or sweet tastes (it told me I like both), or if I’m more likely to sneeze in the sun (apparently I am). My report was mildly entertaining for a few hours, but it revealed no real life-altering information. I didn’t open it again until last month, when I dumped its contents into DNA Lifestyle Coach.
By then, the FDA had softened its stance on 23andMe’s tests and granted the company approval to tell its customers whether they have an increased risk for 10 specific conditions. These include Parkinson’s, late onset Alzheimer’s, Celiac disease, and a handful of other disorders that can affect movement, blood clotting, digestion or other health issues. My updated 23andMe report offered the reassuring words “variant not detected” alongside each of the conditions.
But in the years since the legal drama first began to unfold with 23andMe, other sites were ramping up, carefully tiptoeing around the kind of rules that could get them a cease and desist letter from the FDA.
DNA Lifestyle Coach has avoided this controversy, for now, by steering clear of medical discussions, McCarren tells me. When a genetic test company tells a customer: “You have nine times more likelihood of developing heart disease—take two aspirin a day,” he believes that is when the legal terrain gets murky. DNA Lifestyle Coach “is not a product to help you manage disease,” he says. “This is a product to help you make better lifestyle decisions.”
It’s not so different from seeking advice from a personal trainer at your gym, or a diet and fitness book on Amazon, McCarren says. Maybe you will see health improvements, maybe not, but you won’t get a medical diagnosis and you won’t risk doing any real harm. The difference, he adds, is “that there is strong enough evidence there to give people useful advice, which is better than just throwing a dart at a (diet) board and saying, ‘I’ll go with this one.’”
Most of these companies rely on similar data sets and “package it in different ways to try to make it understandable,” Barry Starr, another geneticist from Stanford University, tells me. “I was trying to think of a result that would make me change my lifestyle—I couldn’t think of one.”
There is just still so much geneticists still do not know, Starr says. Just because 23andMe cleared me of variants for 10 conditions does not at all mean I won’t still develop any one of them. One gene sequence is most likely part of an orchestra of a dozen or even a hundred others (many not yet identified)—all interacting to create a particular result. We also have gene sequences that protect us—which can counteract the “bad” SNP affects.