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

Dave Sill sparge at gmail.com
Wed Nov 27 19:14:48 UTC 2013


On Wed, Nov 27, 2013 at 1:59 PM, Adrian Tymes <atymes at gmail.com> wrote:

> On Wed, Nov 27, 2013 at 7:14 AM, Mike Dougherty <msd001 at gmail.com> wrote:
>
>> So you can "ask your doctor" about drugs for your scaly, red, itching
>> skin that has a side effect of "death" or some heartburn meds that give you
>> low magnesium levels and risk of bone fractures - but you can't swab some
>> spit into a cup because the resulting test(s) has the effect of education
>> about information you might not be prepared to learn?
>>
>
> No.  Because the information stands an unacceptable (to the FDA) risk of
> being flat-out wrong.
>

How much risk of wrong genetic test results is acceptable to the FDA? How
much does 23andMe have? Doesn't the use of a CLIA-certified lab address the
quality of the results?


> It's one thing if it advises someone of a condition they didn't know they
> had, for which there is a risky treatment option but less risky than doing
> nothing.
>
> It's another thing entirely if this advice is incorrect, and the person
> never had that condition in the first place.  This is one of the things the
> FDA exists to prevent, and what it says is going on in this case.
> (Specifically that there are high enough odds that it's happening to a
> significant number of 23andMe's customers.)
>

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?

Rake the FDA over the coals for what it actually does do badly (and doesn't
> do that it should), but let's confine the accusations to what's actually
> going on, please.  There's more than enough without exaggerating or making
> stuff up.
>
> (It's possible that you might have simply misread, but it seems at least
> some people seem to be willfully misinterpreting what's going on here.)
>

Can you give a hypothetical scenario that demonstrates the unacceptable
risks presented by 23andMe? Honestly, I want to understand.

-Dave
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