Tuesday, November 26, 2013

23andme and the FDA

Apparently the FDA wants 23andme to stop selling genetic testing kits.  I think this is a really bad thing.

It seems that if they could, the FDA would block access to mirrors because of the detrimental effects they might have on segments of the population that might take the data provided to them there, become unhappy, eat more cheetos and then die at a faster rate than the mirrorless...

There is no doubt that some people might look at the data provided by 23andme and related services and make poor decisions about their health and its a huge challenge to translate this kind of data into clear medical advice given what is known now.  But (a) its my f'ing genome I should be able to look at it if I want to (b) they are an information service, not a healthcare service and they make that distinction very carefully - they don't say "you should take this drug.." they say "you are at greater risk for ..., so you should go talk to your doctor...".  Sorry, but there needs to be some accountability on the part of the consumer.

Trying to stop personal genomics companies like this from operating until every bit of information they show has run through the FDA will only improve one thing - the economies of other countries without these kinds of problems.  Not to mention the fact that without data collection strategies like this, we will likely never be able to generate the data that would allow these services to get to the point of making a major positive impact on healthcare.  e.g. here is proof-of-concept paper that from 23andme that has been followed up by many new discoveries made possible by their service.  http://www.ncbi.nlm.nih.gov/pubmed/21858135

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