Genetic testing company 23andMe must immediately stop marketing its saliva test kits, the U.S. Food and Drug Administration demanded in a strongly-worded letter made public on Monday.  The FDA said the Mountain View company has been selling the product without the FDA’s sign off, even while marketing it for purposes that clearly require the agency’s approval, “as FDA has explained to you on numerous occasions,” the letter read.  The company was founded by Anne Wojcicki, the wife of Google founder Sergey Brin, although the two are separated.  “Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the (Personal Genome Service) for its intended uses, which have expanded from the uses that the firm identified in its submissions,” the letter stated.  The concern is that consumers are relying on these tests to form critical health decisions, even though the tests themselves might produce inaccurate results about genetic susceptibility to serious diseases. It raised the specter that women could undergo prophylactic surgeries, including removal of their breasts or ovaries, to reduce the risk of breast and ovarian cancer based on false positives.  “If the (gene mutation)-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist,” the FDA stated.  23andMe co-founder Linda Avey had this to say on Twitter:  .@US_FDA warning letter to @23andMe. So much for patient empowerment. http://t.co/3TOk1C9ULh #priorities #Riskmanagement  — Linda (@lindaavey) November 25, 2013  A 23andMe spokesperson provided the following statement:  We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.  Other observers on social media shared the sentiment that this was a case of regulators getting in the way of progress or innovation.  The FDA warning letter to 23andMe shows how hard is to reconcile regulation with innovation http://t.co/trrFG4jpQ7 via @BioDueDiligence  — Dani Nofal (@dnofal) November 25, 2013  FDA decides I’m not smart enough to make up my own mind about @23andme. Next: will they make me return my gene data? http://t.co/sCTQXsm8MM  — Richard Sprague (@sprague) November 25, 2013  To be sure, there is great potential in these sort of genetic tests to help people evaluate their specific health risks and modify their lifestyles accordingly.  “Instead of saying you’re 50 so take this pill, let’s start to personalize this,” said David Agus, a cancer researcher and co-founder of genetics testing company Navigenics, during a keynote at the Dreamforce conference last week. “Let’s start to do what matters to the individuals.”  But it’s worth adding here that the FDA evaluates the efficacy of medical tests and treatments because entrepreneurs throughout history have been happy to make bold promises about health benefits with absolutely no scientific basis. The United States has a rich history of salesmen pushing snake oil, tonics, healing crystals and ineffective herbs.  Nothing suggests anything like that is underway here, given the medical expertise at 23andMe. But there are at least two issues worthy of consideration.  First: how will patients with no expertise respond to complicated test results without the counsel of a medical professional? Will they self-treat and medicate based on vague understandings of their risks? And does that pose additional health risks?  Second: Leading medical experts develop products that don’t work the way they hoped or expected every day. It’s why the government requires drugs and devices to go through rigorous tests using established scientific methods before companies are allowed to create ads saying they’ll improve health. They also have to disclose the known side effects so we can all make informed decisions.  Silicon Valley whines any time regulators bog down their ability to “move fast and break things.” But as a society, we’re far better off when a neutral party that isn’t in the business of selling a medical product takes steps to ensure it does more good than harm.
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