FDA oversteps on genetic testing: Opposing view

Berin Szoka

The Food and Drug Administration has ordered 23andMe to cease all marketing. This blocks 23andMe from spreading awareness of the benefits of genetic testing just as many Americans might, for the first time, have considered giving away the company's $99 saliva home-testing kit for Christmas.

The FDA worries that giving Americans more information about their own genomes might lead some to get too much medical care — or not enough. The letter claims a false positive for a breast or ovarian cancer risk factor "could lead a patient to undergo prophylactic surgery, chemoprevention, (or) intensive screening ... while a false negative could result in a failure to recognize an actual risk that may exist."

But are Americans really so foolish with their own health? The FDA can't cite a single example of someone actually being hurt because of 23andMe. Indeed, 23andMe has peer-reviewed research showing that its customers are no more likely to over- or under-estimate their risks.

Worse, the FDA says nothing of 23andMe's benefits. The company has slashed prices 90% since 2007. At $99, its comprehensive test is cheaper than getting tested for many single risk factors by Old Medicine companies.

Even more important, mass-marketing 23andMe could change the cultural paradigm of medicine: The more people get tested, the more will ask their doctor about their results, and the more doctors will have to start incorporating personalized genomics into their practices.

When I got tested in 2011, I was the first to ask my doctor's office about genetic results. Exasperated with the transition to electronic medical records, they weren't eager to deal with yet another change. But the more patients ask, the more doctors are listening. That's what the Internet has done in countless industries: Force old dogs to learn new tricks. It's never pretty, but the results have been overwhelmingly positive.

But the FDA doesn't care about these benefits — only that someone might, theoretically, get hurt. It wants 23andMe to spend years jumping through bureaucratic hoops, which means delaying the inevitable shift in how medicine is practiced.

Government has a role in protecting consumers from inaccurate testing and misleading information. But if medical innovation is to thrive, the FDA should bear the burden of showing that services such as 23andMe do more harm than good. Thus far, it hasn't.

Berin Szoka is the president of TechFreedom, a Washington-based think tank focused on policy issues raised by disruptive innovation.