The 23andMe Controversy

Here is the 23andMe ad:

The New York Times reports, “In a crackdown on genetic testing that is offered directly to consumers, the Food and Drug Administration has demanded that 23andMe immediately cease selling and marketing its DNA testing service until it receives clearance from the agency.”

Christine Gorman, editor in charge of health and medicine features for Scientific American, says that the FDA was right to block 23andMe, and goes on to say, “At present, getting raw data about your personal genome is worse than useless, as Nancy Shute pointed out in a Scientific American article that I edited back in 2012.”

Not everyone, however, agrees. Nick Gillespie, editor in chief of Reason.com and Reason TV, responds, “when it comes to learning about your own goddamn genes, the FDA doesn’t think you can handle the truth. That means the FDA is now officially worse than Oedipus’s parents, Dr. Zaius, and the god of Genesis combined, telling us that there are things that us mere mortals just shouldn’t be allowed to know….”

Smithsonian.com explains the FDA’s concern, and provides this example, “For instance, if the BRCA-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.”

Shannon Brownlee, who is Bernard L. Schwartz Senior Fellow at the New America Foundation, has additional concerns about business motives (Data mining your DNA). She writes in Mother Jones, “23andMe’s long-term revenue model has little to do with selling kits and everything to do with selling customer information to drugmakers and others in need of human guinea pigs for clinical research.”

Kerry Grens, TheScientist, sums up the situation, “The FDA gave 23andMe 15 days to respond with a description of how it’s addressing the agency’s concerns.”

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Note: The video embedded in this post is no longer available. Here’s an update from 23andMe Blog:

Pending an FDA decision, 23andMe no longer offers new customers access to health reports referred to in this post. Customers who received their health information prior to November 22, 2013 will still be able to see their health reports, but those who purchased after that time will only have access to ancestry information as well as access to their uninterpreted raw data. These new customers may receive health reports in the future dependent on FDA marketing authorization.

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