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

spike spike66 at att.net
Wed Nov 27 16:18:38 UTC 2013


 

 

From: extropy-chat-bounces at lists.extropy.org
[mailto:extropy-chat-bounces at lists.extropy.org] On Behalf Of Mike Dougherty
Sent: Wednesday, November 27, 2013 7:14 AM
To: ExI chat list
Subject: Re: [ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

 

On Wed, Nov 27, 2013 at 6:14 AM, BillK <pharos at gmail.com> wrote:

 

>>.However the FDA are getting annoyed after four years of discussion, so
may take other actions like an injunction to stop the business and
civil monetary penalties. Google are probably not worried about
monetary penalties, but going by history it is not wise to pick a
fight with the FDA.

 

>.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?

 

>.Seems like the addition of disclaimers like "for entertainment purposes
only" or "not intended to diagnose or treat..." would be sufficient to tell
the FDA to get the hell out of my business.

 

>.But I guess that IS the FDA business, isn't it?

 

BillK, in the USA, it can cost over 500 million dollars to get FDA approval
for a new drug or medication.  For decades, the USA was doing the heavy
lifting on developing new drugs and proving efficacy, with its
medicine-for-profit system.  The entire world benefitted.  The price of that
FDA approval eventually got high enough that it is not profitable for a
company to develop new antibiotics, so that ended.  The bugs are evolving
around our older drugs.  That is a perfect example of a violation of the
Hippocratic notion of doing no harm.

 

23andMe is related to Google.  Now there's company.  It just showed up one
day, back in the late 90s.  I have used it nearly every day since that time.
It is competent in figuring out what you want even if you don't really know
yourself, then finding it for you, and it is FREEEEEE!  It's the
libertarian's dream: it empowered the proletariat with KNOWLEDGE!  A pauper
could be living in a cardboard box and eating out of the dumpster behind
Kentucky Fried Chicken, wrapping the body in discards from the Salvation
Army, yet could walk over to the public library, get on their computers on
Google and there is the world's wisdom, right there, just as accessible to
the completely penniless pauper as it is to the Italian-suited executive.
In some ways, it is more accessible to the pauper: she has plenty of time.
The executive is busy as hell and has no time for Googling.

 

23andMe is a product which does no harm but does plenty of good.  Example:
23andMe reveals you have both markers for Farklestein's schnarkoma, an
obscure disease which your former doctor never heard of (your former doctor
is the doctor you liked and can keep period end of story.)  Even if
penniless and living in a box down by the tracks, the pauper can go to the
library, google on Farklestein's and educate herself on how to deal with it,
and while she is there, she can google on where some local will give her
food.  A pauper *might* be able to scrape together a hundred bucks for a
spit kit.  I see people handing cash to clearly phony will-work-for-fooders,
I have done it myself (I try to not make a habit of it.)

 

So let's see a showdown between 23andMe vs the FDA.  This is a fight which
has been long brewing.  There appears to be a clear moral right and wrong
here.  It does to me.  What does it look like from that side of the
Atlantic?

 

>.Note that the FDA is not complaining about the genealogical DNA analysis.
You can still trace your relatives and there are other companies doing this
analysis. No problems with that.

 

>.It is the medical 'snake-oil' that the FDA doesn't like. And it has a lot
of medical and scientific support.

Do these DNA risk factors mean anything? What about all the other genes and
epigenetic factors not checked? What about false positives and false
negatives? Do these tests actually work?  It is all unverified.

 

>.I think it is too early to be making health recommendations. We don't know
enough about how our DNA affects us and how genes interact with each other.
More research is required.

 

>.Maybe if 23andMe enhanced the genealogy side and toned down the medical
side to vague 'worth asking your doctor about' hints, they might keep the
FDA happy.BillK

 

 

Ja to all.  I received this seconds before I hit send.  I think you are
right, but at this point I am not sure we want to keep the FDA happy.  I
think it is time to stand and fight.  We have let the FDA strangle us for
too long.  Time to stand and show some of that good old American
don't-tread-on-me grit in the face of a battle I think the people can win.
In the setting of a spectacular failure of bureaucratic control over
medicine, and a spectacular success of a private enterprise, the time is
right for a test case, especially considering it is an odd year, so the
halls of congress will soon be vacated, the representatives off campaigning
for re-election.

 

spike

 

 

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