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The FDA vs. Information

Dec 9, 2013, Vol. 19, No. 13 • By THE SCRAPBOOK
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It’s difficult to think of a company doing anything as gee-whiz neat as 23andMe. The Mountain View, Calif., firm, which opened its doors to the public in 2007, provides comprehensive genetic tests to anybody with $99 to spend. Customers send in a saliva sample and about six weeks later get access to a detailed website explaining their unique genetic code along with an opportunity to connect with (usually distant) relatives who have also done business with 23andMe. For those who use it, the results are endlessly fascinating; for scientists, the company’s trove of genetic data is hugely valuable. And that’s why it’s outrageous that the Food and Drug Administration has ordered 23andMe to stop selling its kits.

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The FDA’s letter demanding the company to stop doing business is a model of bureaucratic overreach. It claims that the 23andMe test tube kit is a “medical device,” because it provides information about the “diagnosis of disease” but isn’t proven to be as accurate as the bureaucratic mandarins wish it were. As an example, the FDA speculates that false positive markers for breast cancer could lead women to “undergo prophylactic surgery, chemoprevention, intensive screening.”

This sounds pretty scary. Until one realizes that no doctor wanting to keep his or her license would ever perform any of these procedures without a battery of other tests and evaluations. Or that genetic sequences in apparently healthy adults are almost never—in themselves—the cause of disease but, rather, simply indicate risk of disease. Or, for that matter, that 23and-Me’s genetic testing, whatever its imperfections, provides vastly better medical advice than a huge number of self-help books and websites that the FDA (thankfully) has no ability to regulate.

In the end, 23andMe provides nothing more than information—useful, fascinating, potentially life-saving information. Banning the company’s products and services won’t save a single life, but it does reflect an overbearing, paternalistic mindset on the part of the FDA’s staff. There are certain things, even about individuals’ own genetic codes, that the FDA just doesn’t think Americans should have the opportunity to find out. 

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