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23andMe gets censored by the FDA. Its about time
Posted: 02 December 2013 05:48 AM   [ Ignore ]   [ # 16 ]
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mckenzievmd - 01 December 2013 02:15 PM

If you read the FDA letter and look into the history of the interactions between FDA and the company, it is clear that the company has been unable or unwilling to provide appropriate research evidence to show that all of their tests are accurate and reliable. Apart from the important concerns macgyver raises about what to do with information about specific genetypes, it isn’t even clear that the information the company provides is correct. It is bad enough to tell someone they have a genotype that might affect their risk of a certain disease and then provide them with no reliable information about what this actually means for them or what they should do about it, but it is even worse to do so when they don’t actually have that genotype, which is what is likely to happen if the tests are not properly validated.

Again, they do provide one with all the necessary information explaining what it all means. They also rate the reliability of the findings and add links to the studies on which the findings are based. As far as I can tell they have done everything they could. The one who is being dishonest here is the FDA as you can see in one of my links above. Keep complaining, guys, but all of what you said here thus far is simply not true. And as I already told macgyver, if you think this type of research is wrong, you will have to apply the same kind of objection to every other correlational study. Nowhere does 23andMe tell one that gene X will cause you to develop disease Y. Nowhere.

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