[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

Dave Sill sparge at gmail.com
Wed Nov 27 20:03:11 UTC 2013


On Wed, Nov 27, 2013 at 2:44 PM, BillK <pharos at gmail.com> wrote:

> On Wed, Nov 27, 2013 at 7:14 PM, Dave Sill wrote:
> > What evidence is there of that, and that it's resulted in actual harm
> due to
> > people not following 23andMe's disclaimer that their reports aren't
> intended
> > for diagnostic use?
>
> That disclaimer is very similar to the fraudulent mediums and
> astrologers saying 'for entertainment purposes only'. Their customers
> give them money and believe what they are told, knowing that the
> disclaimer is just a wheeze to get round the law..
>

Similar, but fundamentally different. 23andMe results really don't
*diagnose* any diseases, they merely indicate genetic susceptibility to
them. And they make that very clear.


> > Can you give a hypothetical scenario that demonstrates the unacceptable
> > risks presented by 23andMe? Honestly, I want to understand.
>
> Read the FDA letter. It explains their POV very clearly.
> <
> http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm
> >
> Quote:
> This product is a device within the meaning of section 201(h) of the
> FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the
> diagnosis of disease or other conditions or in the cure, mitigation,
> treatment, or prevention of disease, or is intended to affect the
> structure or function of the body.
>

Well, gosh, yes, if a genetic test shows that I'm more likely to get a
disease, I'll probably change my behavior to avoid that disease. How is
that harmful, even if the test turns out to have been wrong?

The letter continues on to list specific problems.
>
> You are entitled, of course, to disagree with the FDA's opinion. But
> they do have a lot of experience fighting the avalanche of medical
> fraud in the USA.
>

Do you think 23andMe is perpetrating medical fraud?

-Dave
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