FDA's ban on health information from 23andMe

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Adamantium
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06 Dec 2013, 4:56 pm

I was going to give myself a 23andMe kit for Christmas.

I am interested in the genetics of autism. I am quite upset that while the test is still available, 23andMe can no longer provide any health-related information in connection with the test, thanks to the FDA.

I am upset because I wanted this information, but what do you think of this?

The rules designed to govern medical devices seem inappropriate for this purpose.



Dynania
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06 Dec 2013, 5:46 pm

They're the company that analyze DNA, right? If that's the case, I think it's effed up.


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Janissy
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06 Dec 2013, 5:48 pm

You can still get health info it will just take the additional step of downloading your raw data from 23andme (once you have it) and uploading it to an analysis program. The FDA clamped down on 23andme's interpretation of data (boo!) but they are still allowed to give you a raw data listing of hundreds of genes. They just aren't allowed to tell you what it mean in terms of your health.

So here's what you do: get the kit, do the test, and download the raw data onto your computer. Then go to www.snpedia.com which will get you to the promethease analysis program. Upload your raw data to that program and it will give you a report that is the same as what 23andme formerly did (and hopefully will do again at some point) and some additional metabolic info that 23andme didn't provide even though they identified the relevant genes. When I did this several months ago, it cost 5$ to have it done in 2 hours or free if done overnight. I did it for the extra metabolic info. Now that the FDA is clamping down on 23andme, people are probably flooding promethease so it may cost more and take longer.

The big catch is that your raw genetic data loses its protective encryption once you download it off 23andme (it has to or you couldn't upload it to any other program) so when you release it out into the wild via promethease......it's out there. I did it anyway.

Regarding the genetics of autism- promethease flagged me as simultaneously at increased and decreased risk of having it. I assume this is because the genetic research is in its infancy. The place it seems to be at now is that various genes appear more often or less often in people with autism but there are multiple genes and multiple possibilities. It is results like "increased risk of autism because you have the ---gene" coupled with "decreased risk of autism because you don't have the ---gene" that got the FDA all het up in the first place. This ambiguity doesn't bother me because I understand that the research (on many genetic factors, not just autism) is in its infancy and so there will be ambiguity and internal conflict. You have to take the results with a keen eye towards the research and realize that it is in flux. The FDA hasn't yet noticed promethease- perhaps they don't care because promethease doesn't sell a kit- so they are still allowed to give out such ambiguous reports rather than being forbidden to say anything.

I think it's worth it because while the interpretation of what genes mean will change and change fast as papers get cranked out, what won't change is what genes you personally carry. The raw data alone is worth more than 99$. You can re-interpret it in light of future research at a later point.



Adamantium
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06 Dec 2013, 7:33 pm

Thanks, Janissy!

I will check out promethease. Metabolic information would also be good to have. SNPEdia is a great resource. I am not so paranoid about having genetic information out there--I am shedding DNA bearing material all the time (hair, skin cells, etc.)--if "THEY" want it in order to establish a GATTACA like system, they can do so without my consent.

I don't understand why the FDA has to pretend that medicine is more precise or accurate than it is. By all means by rigorous in protecting the quality of pharmaceuticals--but test results? Is there a suggestion that the data 23andMe is generating is bad? If not, they should let people decide for themselves whether to use it or not.