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

Adrian Tymes atymes at gmail.com
Thu Nov 28 17:23:54 UTC 2013


On Thu, Nov 28, 2013 at 8:56 AM, Mike Dougherty <msd001 at gmail.com> wrote:

> In the interest of protecting the people, we should make sure WebMD only
> sends information to licensed doctors.  We should make sure Home Depot only
> plays HowTo videos to licensed carpenters and plumbers.  Stock information
> should only be available to licensed bankers and legal information should
> only be available to licensed lawyers.  Of course only politicians should
> know anything at all about what goes on in government, right?
>

Your analogy is flawed.

The FDA has said it would have no problem with 23andMe communicating the
information as to what genetic markers mean to the public *if this
information was proven correct*.

Problem is, 23andMe has not provided this proof to the FDA's satisfaction.
(Sure, they can prove that they have the correct markers.  That's not the
part the FDA's objecting to.)

Can you explain how information about my own genetics that I am buying from
> a company that provides this service should be blocked by the FDA?  I feel
> that we are either entitled to transact this business (in which case the
> FDA is interfering with my transaction) or we the people are too
> stupid/irresponsible to act on our own (in which case the FDA nanny is
> keeping us safe)  Honestly, if you can enlighten me I'd appreciate the
> effort.
>

I have explained multiple times.  In short: if this information suggests
that certain things would be healthy for you when in fact they are not,
then they are causing you to be less healthy than you otherwise would be.

Basically it's the latter case from what you said, except instead of
"stupid/irresponsible" try "misinformed".  If your doctor told you that
taking pill X would improve your health, most Americans would take pill X
without any further research.  The FDA's issue is that this level of trust
is being extended to 23andMe when, in the FDA's opinion, they have not
earned it.

Now, it could well be that the information about what genetic markers
trigger what is all accurate.  If so, it should be a simple matter to prove
this to the FDA.  That 23andMe has not done this suggests that either the
information is not in fact trustworthy, or that the real issue is something
else (but if that is the case, 23andMe should have said so by now).
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