In Taking Aim at 23andMe, Regulators Missed the Mark
Is knowledge really that dangerous?
It's a question worth asking in the wake of the controversy over 23andMe, the genetic-testing company backed by Anne Wojicki and her estranged husband, Google co-founder Sergey Brin. The Food and Drug Administration ordered 23andMe to stop selling its home-testing kits, saying there isn't enough data to prove the kits work.
But, as regulators often do, the FDA went a step further, fretting aloud that people might undergo unnecessary surgeries because of shoddy test results. In a letter to the company, the FDA said false positives could “lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions.”
There was already a healthy amount of regulatory skepticism over 23andMe, with some states not allowing the kits because saliva would be transmitted by mail and others questioning whether the tests were all they were cracked up to be.
But the FDA, in worrying about treatment for potential diseases, took concerns a step further, and, in the process, may have missed a point: 23andMe treated no illness, nor did it counsel any patient about a health-care regimen. Rather, it had the potential to be a guidepost for people to take the management of health into their own hands. It was about information, not action.
Take a patient who may have learned she had a predisposition for breast cancer. The FDA, in its response, says that could have a patient run to a surgeon to get a mastectomy. But health care doesn't work that way. At minimum, that patient may see a doctor, discuss health history, and hear options. In those cases, there will be actually tests performed, like a mammography. Some of those tests could detect tumors, lead to treatment – and, crucially, save a life.
23andMe testing kits don't come with home-treatment products. One can't lop off a breast because a genetic test made you worry about your disposition to a disease, so the FDA's concerns are silly. Yes, there may be false positives and false negatives, but 23andMe was not diagnosing anything. Ever use a home pregnancy test? There are countless reasons for the notorious false readings in those, but the FDA doesn't worry you will jump to schedule a home Caesarian section once your pee turns the second line pink.
Knowledge is power, yet regulators -- from God with Adam and Eve to the FDA with 23andMe – have been telling us it is a forbidden fruit not safe for our lips. There is a nanny-state element inherent in the FDA's thinking, with regulators suggesting Americans lack the sophistication to evaluate the information they receive. We need, after all, to be protected from ourselves.
Sadly, 23andMe didn't help its own cause by failing to communicate effectively with the FDA and meet deadlines. That is often a more unforgivable sin for regulators than actually presenting bad data. But, with the prohibition to market 23andMe's tests, the FDA runs the risk of robbing patients with data that could be useful in promoting their health and safety.
The FDA should be in the business of keeping Americans from harm. But no regulator should assume that, to do that, you have to save Americans from themselves.
For reprints and licensing questions, click here.