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

Dave Sill sparge at gmail.com
Wed Nov 27 20:14:26 UTC 2013


On Wed, Nov 27, 2013 at 2:57 PM, Adrian Tymes <atymes at gmail.com> wrote:

> On Wed, Nov 27, 2013 at 11:14 AM, Dave Sill <sparge at gmail.com> wrote:
>
>>
>> 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?
>>
>
> Worthy questions; these items are likely in the details of the FDA's
> communications.  Although the last one can be answered "no": it's not "do
> you have this marker" that's the problem, but the information they attach
> to it.
>

Ah, so if they didn't include an explanation of what the SNPs they found
mean, then FDS would be OK? But, of course, that information is extremely
useful.


> 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?
>>
>
> Again: a good question to address to the FDA.  Although the FDA's policy
> is "prove it doesn't do significant harm", not "prove it has caused
> significant harm".  While this does veer toward the precautionary
> principle, and the high costs of meeting their standards are a continuing
> problem in the biotech industry, many cures and treatments over the years
> have been able to meet those standards: it's not impossible for stuff that
> works (even if it is a lot costlier than it could be).
>

But we're talking about testing, not cures/treatments. The 23andMe test *cannot
*itself be harmful--it's spitting in a tube.


> | Can you give a hypothetical scenario that demonstrates the unacceptable
> risks presented by 23andMe? Honestly, I want to understand.
>
> I did (in the "one thing...another thing" quoted above), but I'll restate:
>
> Let's say 23andMe says you have a 95% chance of having condition X.
> Condition X has a 90% mortality rate over 5 years if left untreated.
> However, there is a treatment that completely cures this condition,
> although it itself has a mortality rate of 10% over 20 years.
>

At that point, I'd have to consult a physician in order to get the
treatment, right? 90% mortality meds aren't over-the-counter. And doctors
don't administer them without being pretty damned sure they're necessary,
so the doctor will order his own tests. 23andMe can only raise awareness of
potential issues, it doesn't diagnose them or treat them.

-Dave
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.extropy.org/pipermail/extropy-chat/attachments/20131127/8090893e/attachment.html>


More information about the extropy-chat mailing list