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01 December 2013 @ 10:18 pm
Spitting into a test tube considered harmful?  
I find it ridiculous that the FDA objects to 23andMe's test kits: Getting your DNA tested really can't hurt you. The FDA's theory is apparently that someone might find out that they have a genetic risk for something, and do something dangerous as a result. Still, most of the medically dangerous things that you might do as a result (unnecessary surgery?) require a doctor's assistance, and that's really the proper place to inject sanity as required.

Apparently there's a whitehouse.gov petition to ask the FDA to reconsider their ban:
https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB
 
 
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Steuard: lakesteuard on December 2nd, 2013 01:04 pm (UTC)
So, I'm horribly torn on this. My initial reaction was exactly the same as what you've described here: I emphatically don't want the government to "protect" informed citizens from gathering information about themselves. (I recognize the risk that some people will make poor decisions based on that information, but within limits I consider that to be a fair trade-off for better information for the rest of us.) I really liked getting my own results from 23andMe, and I consider the things I learned to be valuable.

But then I read the full FDA letter to 23andMe. From what I read there, it sounds like a big part of what 23andMe has failed to provide (despite years and years of requests) is clear evidence that their tests are really accurate. And that's where I do emphatically support FDA oversight. If I send a spit sample to a company like 23andMe I want to be confident that the results that they send back are trustworthy, in the same way that I'm confident that drugs I buy at a pharmacy are pretty certain to match what's on the label. I know that I don't have the expertise or the time to verify that myself, and honestly, I'm pretty sure that the friends who told me about 23andMe and vouched for them don't have that expertise either.

Prior to reading the FDA letter, I had just assumed that 23andMe had at some point done the rigorous tests that would be necessary to convince independent observers that their results are accurate. But if they had those results, they would have been able to send them to the FDA when asked, years ago. The fact that they don't suddenly makes me wonder whether I can trust any of the results they gave me. And that worries me a lot.
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