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FDA Orders 23andMe to Stop Providing Genetic Analysis.

Discussion in 'Genetic Testing and SNPs' started by wdb, Nov 25, 2013.

  1. Esther12

    Esther12 Senior Member

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    I think that it's a mistake to view genetic testing in primarily medical terms, rather than political. To a large extent, British and American societies are built upon myths about 'equality of opportunity', exaggerated claims about individual's control over their own lives, and so on. The more accurate information we have about reality, the more those myths are challenged. This is going to be important in medicine, for insurance (will insurance companies be able to insist people get tested?), pensions, for decisions about how people are valued, and so on. If people have genetic results which indicate a high probability of early death or disability, how will that affect their rights and responsibilities in society?

    Currently this is just an emerging issue, but there will be a lot of interested parties with a lot of money and influence who have clear ideas about how they want things to go, and what outcomes they want to avoid. If genetic testing does end up providing the sorts of important information people expect, it will have a profound impact upon lots of areas of life, and this makes me instinctively sceptical of any attempt to control it (even if I currently think the FDA has some fair but minor reasons for concern with 23andMe)
  2. biophile

    biophile Places I'd rather be.

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    I guess 23andMe may have to tone down some of the medical advice? I care more about the accuracy of the testing technique for data reuse. If I had the money I would send the same sample under two names and check for differences.

    So when are letters being sent to CBT/GET practitioners who have charged money and mislead ME/CFS patients about the size and nature of the effects and the safety profile? Oh that's right, regulation is almost non-existant for that.
    Last edited: Nov 28, 2013
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  3. barbc56

    barbc56 Senior Member

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    I forgot to cite my sources from my previous post. Someone did just this. This article also shows that there could be problems with the questionaire.

    http://discovermagazine.com/2008/sep/20-how-much-can-you-learn-from-a-home-dna-test#.UpeLeajnaAhhttp://discovermagazine.com/2008/sep/20-how-much-can-you-learn-from-a-home-dna-test#.UpeLeajnaAh
  4. alex3619

    alex3619 Senior Member

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    The problem with SNP testing is that its about the SNP technology itself. Each company builds a library of SNPs and tests for it. Different companies will have different SNPs in their library. Without a complete genome sequence there is no way to be sure of genetic accuracy as only SNPs are detected. Even with a complete genome sequence our understanding of the genome is still in development.

    I expect there to be differences in testing from different companies. What should not be different is whole genome testing.

    SNP interpretation is something else. Just by chance many predictions will be wrong, because in most cases they work on association not causation. If the published science says SNP A is associated with disease Z then they will put that in the profile. The biggest issue though will be the unknown, either SNPs we don't know about yet, or consequences from SNPs we don't know about.

    Most of the companies creating such profiles will be struggling to keep their analysis software up to date. Its constantly evolving. The results you get on one set of SNPs one year might be different a few years from then.

    This is not really science, its about issuing advice that might help you manage possible risks.

    One thing people should be aware of, and I haven't looked at 23andMe for a long time, is the difference between absolute and relative risk. An absolute risk of 10% is worrying, and cause to look at prevention. A relative risk of 10% could be almost anything. If the average person has a risk of 0.01%, then a relative increased risk of 10% is only 0.011% in absolute terms. Small potatoes, don't panic. That's only 11 chances in 100000.
    Last edited: Nov 28, 2013
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  5. Sea

    Sea Senior Member

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    Very interesting article, thanks Barb.

    There was some confusion over the differing "results" from the different companies. On reading carefully though the differences were not in the raw data but in the interpretations of that data.

    I don't have a problem with that. The risks are not absolute, they are based on whatever research on whatever snps the particular company is aware of. As long as they make clear it is preliminary research, that calculations will change as more research happens etc I'm good with that.

    Another confounding factor for this reporter is her mixed ethnicity. The research is in it's infancy in all races, but even more so in those who are a mixture. Until much larger populations are studied conclusions will not yet be reliable.
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  6. biophile

    biophile Places I'd rather be.

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    I only skimmed through the Discover Magazine article, but it seems like early days yet for genetic testing. Last time I checked, 23andMe graded the strength of the evidence/research cited. People shouldn't start panicking over flimsy evidence.

    I mostly got the 23andMe test out of curiosity and the possibility of insight into methylation tendencies. My friend also sent off a sample before me and then told me about a special offer. I never really expected it to be the gospel on my genetic makeup, and it only tests 10% of the DNA or something, so more of a mere glimpse or guide unless better testing is available?

    If the data says I am 20% less likely to get disease X, or 30% more likely to get disease Y, I am not going to start worrying about it. 23andMe claim that I am twice as likely to get Alzheimer's disease. My great grandmother had that so I already was prepared for it. There isn't much I can do about that right now whether it happens or not.

    23andMe may be useful for finding obscure genetic problems?
    The ancestry part of 23andMe was also interesting.

    I received this email from 23andMe recently:

    Last edited: Nov 28, 2013
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  7. jeffrez

    jeffrez Senior Member

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  8. taroki

    taroki Senior Member

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  9. lnester7

    lnester7 Seven

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    I got order confirmation so they must still be shipping.
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  10. Bob

    Bob

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    According to this article, the FDA has not banned the sale of testing kits, but has only ordered the suspension of marketing activities. The current situation seems to be part of an ongoing dialogue between the FDA and 23andMe, and is not necessarily permanent:

    23andMe suspends marketing after failing to meet FDA requirements
    At-home genetic testing kits still for sale on company website while FDA questions claims made by marketing material
    Tuesday 3 December 2013
    http://www.theguardian.com/science/2013/dec/03/23andme-suspends-marketing-fda-order
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  11. caledonia

    caledonia

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    Dr. Ben Lynch said he got an email from 23andme to stop recommending the test in 7 days. He thinks you should order yours today if possible. I saw this on Facebook.
  12. Firestormm

    Firestormm Guest

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    Bob, did you notice the class action lawsuit referred to at the foot of that report?
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  13. Esther12

    Esther12 Senior Member

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    I'll order a test if it's a route to a cut of google riches!
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  14. Bob

    Bob

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    Yes, I did, and the article includes a link to the details of the class action.
    But I'm not sure why you asked me that question?
    I haven't taken much interest in 23andMe, so I don't have any meaningful insight into the significance of the class action, or the FDA action.
    Last edited: Dec 3, 2013
  15. barbc56

    barbc56 Senior Member

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  16. Bob

    Bob

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    You're welcome.
  17. Firestormm

    Firestormm Guest

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    Eh? I asked only in case you'd missed it? :)
  18. WillowJ

    WillowJ Senior Member

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    Not necessarily. I'm not 100% sure of all the implications, but it still takes expensive equipment and many steps to do any sequencing.

    While a full human genome is, I'm sure, enormously complicated, and probably has some additional costs over doing short sequences, the cost for sequencing is not going to be directly related to the length of sequence; some of the time and steps involved would the same (just differing amounts of what you add, and possibly differing amounts of incubation time but again, time not multiplied by amount of DNA--you increase the other materials which compensate for more DNA) no matter how much DNA is being handled.
    Last edited: Dec 4, 2013
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  19. beaker

    beaker CFS/ME 1986

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    question about the kit. To ensure your privacy -- did you register under a fake name or your real name.
  20. Bob

    Bob

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