
The FDA's notes from its visit to Theranos' labs don't look good - bpolania
http://www.businessinsider.com/fda-documents-on-theranos-2015-10
======
kzhahou
The most surprising thing about this whole saga is the way two VCs openly
spoke out against Theranos. Bill Maris from GVentures and Moritz from Sequoia.
I can't remember the last time I saw a VC trash someone else's investment in
public. So why now?

I'll speculate that there's something so distasteful about Theranos --the wild
mismatch between valuation, amount raised, and deliverables-- that these two
investors felt that it threatened the ecosystem itself. Like they needed to
distance Sand Hill Rd from this stinker before it taints the other (still
unproven) unicorns.

Or maybe it was something else, dunno. Anyone else notice it?

~~~
InclinedPlane
I suspect this is going to turn out to be a huge spectacle. One of the
downsides of so much VC cash available is that it's also a lot easier to build
up a very expansive sham company which doesn't have much at its core.

~~~
aagha
I'm curious: What would be the benefit of doing this? Getting investment from
VC's with the hope that it can be turned into something?

~~~
InclinedPlane
The VC game in Silicon Valley isn't about investment, it's about playing the
lotto. You dump money into as many companies that have even a small degree of
promise, you blow them up to the point where you can find out whether or not
they have market traction, and then you collect your winnings from the tiny
fraction that hit it big. Not only is it vastly disadvantageous to not have
your fingers in as many pies as possible but the VCs with the most money are
precisely the ones who have been playing this game already and hit it big with
google, facebook, instagram, etc.

Investing in 9 sham companies that fold and 1 unicorn that pays out at 10:1 or
100:1 is more lucrative than investing in 10 companies with modest, but
reliable RoI's. Peter Thiel's Facebook investment paid off at 2000:1, Accel's
facebook investment paid off at 800:1, Andy Bechtolsheim's google investment
paid off at 17000:1, Andreessen Horowitz made 300:1 off of instagram. If
you've got a good enough pitch you can get as much money as you want.

~~~
shubhamjain
This makes sense for small investments in companies with valuation < $10 MM
but how does one just throw paychecks at valuation ~10B with no significant
introspection?

~~~
InclinedPlane
Theranos' Series C rounds came in at under $30 mil across three different
investors. That's chump change in the VC world, if that's the price of a lotto
ticket, so be it. If you're a VC who's won the lotto before you likely have
over a billion in capital. Pumping $30 mil into 15 ventures doesn't even use
up half of it, and if any one of those end up making true on a huge valuation
while the others just wander into the desert and die, you'll have made back
your lotto expenditures and more.

~~~
neuronic
Looks like everyone learned their sweet lessons from the dotcom bubble...

------
suprgeek
What is alarming and missing from the BI story is that there were two
documents issued by the FDA - one which covers the issues mentioned (more of
pre-market and conduct) the second one listed here:
[http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-
org...](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-
orgs/documents/document/ucm469395.pdf) is equally damming.

This one deals with the requisite post-market aspects (surveillance, complaint
remediation, etc).

For a Medical Tech. start-up to fail on post-market surveillance is in-
excusable. Move Fast & Break Things should not apply to people's health and
medications.

There is something very wrong when a company with that much cash fails BOTH in
pre & post market situations.

~~~
Alex3917
A large percentage of companies don't do their post-market surveillance, and
the FDA has never even once revoked approval because of it. The whole FDA
approval process is basically a scam.

~~~
refurb
Uhhh... that's not correct at all.[1]

Are you confusing it with post-marketing commitments to run additional
clinical trials? That's not the same thing as post-marketing surveillance.

[1][http://www.fiercepharma.com/story/roche-
overlooks-80000-adve...](http://www.fiercepharma.com/story/roche-
overlooks-80000-adverse-reaction-complaints/2012-06-21)

~~~
Alex3917
"Not all Phase IV studies are post-marketing surveillance (PMS) studies but
every PMS study is a phase IV study."

"Under the current system, the FDA has the authority to revoke approval of
some drugs for which Phase IV commitments have not been honored. This
authority has never been invoked."

[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/)

[http://www.citizen.org/hrg1520](http://www.citizen.org/hrg1520)

~~~
OopsCriticality
The Phases apply to _drugs_ , not _devices_.

------
aresant
The lack of factual scrutiny for such potentially life-changing technology is
a shame on both ends of this story.

I mean there are 2 Theranos centers smack in the middle of SV (Palo Alto and
Redwood City) - the WSJ's exposé centered largely on actually trying the tech
and finding others with disparate results - where were the SV / SF / Oak
proper journalists on either end of this story actually scrutinizing a $10b
monster?

"Watching the media build up and tear down Theranos feels the same with the
sign bit flipped. Little data, and lots of hyperbole, both times."

c/o Sam Altman's twitter and he's spot on.

(1)
[https://twitter.com/sama/status/655492875073884160](https://twitter.com/sama/status/655492875073884160)

~~~
patio11
_where were the SV / SF / Oak proper journalists on either end of this story
actually scrutinizing a $10b monster?_

Most journalists are not capable of narrating how e.g. a Rails application
works. They're equally not capable of walking an interlocutor through e.g.
Phase N clinical trials. They rely on people who actually have domain
expertise to tell them what the ground state of the world is like. One would
hope that a _good_ journalist goes around and checks those representations,
but this is not always true.

 _Every_ interaction I have ever had with a journalist attempting to use me as
a source has decreased my confidence in the profession. I'm on like six
organizations' internal lists as "Speaks English and can answer any Japan
question." (My qualifications for this: I speak English, have a professional
background which suggests bare minimum competence in a field which was once
newsworthy regarding Japan, and then was in the NYT in that capacity. "Close
enough!")

They've asked me to provide my opinion of everything from e.g. Abe's economic
policies to whether the man on the street thought that the Japanese women's
soccer team was counteracting the national malaise after the Tokoku
earthquakes. When I give them the honest answer, which is that I'm a small
software entrepreneur who does not know anything useful about nation-level
economics policies and is sufficiently politically apathetic that me knowing
that Abe is prime minister actually means that I must be paying more attention
than usual in 2015, that _does not result in them stopping the interview or
taking me off their list_.

Journalism is a high-prestige field which, to re-use Michael Creighton's
observation, we understand is virtually never right about even the simplest
consequential facts about things we actually understand, but we trust it to be
accurate with regards to consequential facts about other fields, and this
trust endures through every report that we have about journalists being
catastrophically wrong. The alternative to trusting journalism is to believe
that the New York Times and BuzzFeed hire the substantially same people to do
substantially the same work for substantially the same reasons, and that the
NYT is prestigious and BuzzFeed is not because the NYT has been _BuzzFeeding
for centuries_.

There is some threshold of evidence that causes us to accept the BuzzFeed
hypothesis, right? Right? God help me, I know I sound crazy, but I think I'm
there.

~~~
PopeOfNope
_Journalism is a high-prestige field which, to re-use Michael Creighton 's
observation, we understand is virtually never right about even the simplest
consequential facts about things we actually understand, but we trust it to be
accurate with regards to consequential facts about other fields, and this
trust endures through every report that we have about journalists being
catastrophically wrong._

 _There is some threshold of evidence that causes us to accept the BuzzFeed
hypothesis, right? Right? God help me, I know I sound crazy, but I think I 'm
there._

Welcome to the ranks of conspiracy theorists. Anyone willing to admit
difficult truths eventually winds up here.

Is there a time in the history of journalism where journalists were ever right
about even the simplest consequential facts? That would at least explain why
they're still considered a high-prestige field. Anyway, I'd love to find out
how such a worthless field earned and continues to maintain it's prestige.

~~~
cpach
It seems to me that there is a trend that many people start to lose trust in
the credibility of journalism. State-funded troll factories[1] probably helps
with fueling this distrust. There are of course many valid reasons to
criticize media publishers, but I sure hope we could avoid throwing the baby
out with the bathwater.

[1] [http://www.nytimes.com/2015/06/07/magazine/the-
agency.html](http://www.nytimes.com/2015/06/07/magazine/the-agency.html)

~~~
PopeOfNope
This is the point: if there ever was a baby in that bath, it's dead now. Read
what Patio11 wrote again and realize his situation isn't an isolated incident.
It's the norm.

Tell me, cpach, why did you feel the need to defend the news establishment?
You obviously think there's some value they're bringing to the table. What is
that value?

~~~
cpach
I think parts of what the news establishment does are worth defending. Some
parts are definitely despicable. I do not stand wholeheartedly behind them.

But as I said in another comment, how else would you have any idea about what
happens around the world? Do you see no value whatsoever in publications such
as The New York Times, The Washington Post or The Economist? I'm not talking
about The Sun, Fox News or Russia Today.

I see a value in organizations that have the funds to pay for investigative
journalism. A recent example is the private jet scandal within the Swedish
manufacturing company SCA.[1] The newspaper Svenska Dagbladet ran a series of
articles about how the upper management at SCA misused the company's private
jets, costing the company loads of money. Unsurprisingly the shareholders were
not happy and many key persons had to resign because of this.

Had it not been for the articles in Svenska Dagbladet, how would the
shareholders ever find out about this misuse of the company's resources?

[1] [http://www.thelocal.se/20150123/one-of-swedens-most-
powerful...](http://www.thelocal.se/20150123/one-of-swedens-most-powerful-
businessmen-quits)

~~~
PopeOfNope
> how else would you have any idea about what happens around the world?

Since there's nothing I can do about anything anywhere else in the world, why
should I care? Furthermore, if very little the news establishment publishes is
correct, how can you say you have any idea what's actually happening around
the world? You don't. With the readiness with which the news establishment
will publish absolute junk, what makes you think they won't publish what
they're told by their corporate owners or the government? When nobody does any
fact checking, it leaves them (and you) vulnerable to manipulation.

> Do you see no value whatsoever in publications such as The New York Times,
> The Washington Post or The Economist?

None.

> Had it not been for the articles in Svenska Dagbladet, how would the
> shareholders ever find out about this misuse of the company's resources?

Wow, you had to go all the way to Sweden to dig up an example for this? We're
talking about the American news establishment. I have no comment on or
exposure to European news. In the American media, investigative journalism is
a dead art. The disclosures we see in the news are mostly done because we have
a (more or less) open market which gives an incentive for all sorts of people
and organizations to profit from these sorts of disclosures. That part of the
system would work just as well without journalists.

~~~
cpach
> Wow, you had to go all the way to Sweden to dig up an example for this?
> We're talking about the American news establishment.

All the way? Has it occurred to you that not every participant in this forum
is a US citizen?

------
epistasis
>It appears as if this isn't the first time Theranos has butted heads with FDA
inspectors: "This document was provided as a follow-up to the failures in your
design validation conducted in 2014," the FDA report says.

$10 billion valuation, and this is the best they can do?

It seems like silly season is going to end soon. This time there are a lot of
solid businesses in the valley with solid revenue and solving real problems.
Then there are the dilettantes and the scammers. All will be revealed as it
becomes more difficult to raise money.

~~~
ryporter
They may still actually have an real innovation (we need more evidence), but I
do agree that this is a massive failure for such a valuable company. After the
huge setback that 23AndMe suffered from their run-in with the FDA, every well-
funded company under their jurisdiction should be triple-checking everything
related to FDA compliance, since it poses such a grave, existential risk.

~~~
a_bonobo
Interestingly, both 23andMe and Theranos just sat on the documents issued to
them by the FDA, see
[https://news.ycombinator.com/item?id=10462936](https://news.ycombinator.com/item?id=10462936)

Do both have the same guy working on FDA-approval?

~~~
adventured
It's the Uber aggressive approach - break the rules, try to get big faster
than they can slow you down - applied to something directly ruled by a federal
bureaucracy. That'll never turn out well. With the FDA you have to play the
game the way they want you to or they'll instantly nuke your operation. The
Uber approach only works if you're dealing with lots of little bureaucracies.

------
ageyfman
Observation 5: "Documents were not reviewed and not approved by designated
individual(s) prior to issuance."

this one is the most damning. FDA gave them the opportunity to correct this,
and they sat on it for a year.

The culture of move fast and break things is fine for consumer products, but
the cavalier attitude with people's lives is overstepping.

~~~
eitally
I'm tempted to argue that the SV model of tech startups essentially prohibits
the creation of any functional biotech or medical device company. The
compliance and process parts require real industry experience senior
expertise, and time. like you said, a cavalier attitude is completely
inappropriate and will never pass scrutiny.

I worked for a medical device manufacturer for about 15 years. 21 CFR 11, and
the test & quality tracking requirements, make it extremely hard to pivot
quickly.

~~~
ska
Pivoting doesn't make a lot of sense in this space.

However it is entirely possible to be agile and (relatively) fast in this
space - not by breaking rules but by designing the process to be light where
it can, detailed where it must. And then paying attention to how it is working
and improving it constantly. You can probably cut time to market in half
relative to industry averages this way, which is nothing to sneeze at.

~~~
hga
Pivoting after losing your reputation for quality and playing straight with
the FDA makes no sense whatsoever to me. In fact, the FDA is known for getting
very vindictive after that sort of thing happens.

I count this as different than the 23AndMe situation where they're arguing
with the FDA over how the results can interpreted and passed on to the
consumer, that's a difference in opinion that doesn't rest on the quality of
the testing science.

~~~
ska

       that's a difference in opinion
    

Indications for use aren't a matter of opinion. 23AndMe clearly screwed up
there, but I agree it was a different nature of screw up.

------
ekianjo
Nothing drastic in such observations, unless you have never seen FDA reports.
The FDA usually issues a lot of observations and calls for corrective actions
- this happens even with large and experienced pharma companies.

~~~
seehafer
I disagree. Device/diagnostic companies get 483's all the time. What's telling
is the scope of these observations. Theranos is failing on most counts of the
quality system regulations. Judging by the observations they don't even have a
corrective action (CAPA) process. That's a huge red flag.

~~~
ekianjo
> Judging by the observations they don't even have a corrective action (CAPA)
> process. That's a huge red flag.

Well if they want to hire folks out there there's a huge amount of capable
people ready to be poached from other companies.

~~~
hga
I can't imagine many people being willing to move to Theranos today, as long
as their current job isn't totally awful. Reputation is very important in this
field; heck, if I saw a resume with someone coming on board at this period,
I'd be asking them some hard questions about why they did it.

------
peteretep
I'm sceptical generally of Theranos, but none of this feels in the least bit
like a smoking gun. Wouldn't you expect feedback like that for a truly
revolutionary product? There's no claim of fraud, there's no claim their
technology doesn't work, just complaints about technicalities. Am I wrong?

~~~
rayiner
The government doesn't give you "feedback." Also, out of the five
observations, only the last one is a "technicality." The process documentation
and design specification and validation issues are not optional. Not just in
medicine, but in any engineering field where lives are on the line.

E.g.

> Observation 1: "Design validation did not ensure the device conforms to
> defined user needs and intended uses."

You don't build a bridge without defining the maximum carrying load you intend
to use it for, or validating that it will carry that load. Getting lucky and
having the bridge not fall down (at first) doesn't ameliorate that process
defect.

P.S. I haven't been following the Theranos story closely. I am taking the fine
article at face value.

~~~
peteretep

        > The government doesn't give you "feedback."
    

[http://www.fda.gov/ICECI/Inspections/ucm256377.htm](http://www.fda.gov/ICECI/Inspections/ucm256377.htm)

    
    
        > when an investigator(s) has observed any conditions
        > that in their judgement may constitute violations
    

Sure sounds like feedback to me.

    
    
        > The process documentation and design specification
        > and validation issues are not optional
    

No, but they can be iterated on.

    
    
        > I am taking the fine article at face value
    

The "fine article" presents small snippets of a heavily redacted article.
There's not that much value to take...

------
rayiner
I hope the industry doesn't draw the wrong lessons from Theranos. Compliance
isn't hard--the expertise is out there. But the process must be followed and
that might mean moving more slowly. Which is okay because your competitors
have to move more slowly too.

What's interesting about Theranos is the hints that the technology may not be
ready for prime time yet either. In which case moving more slowly, and taking
that into account in the funding stages, is not just a reality of compliance
but a reality of engineering. This stuff is hard, MVPs aren't enough, and
successful ventures are going to take longer to yield a salable product than
in other fields.

------
ryandrake
Gushing press, create-a-celebrity CEO, A-list "1%-er" investors... Then,
questionable product/technology? Time to grab the popcorn, this should be fun!

~~~
TazeTSchnitzel
It would be amusing, except I'm worried the dodgy tech has ruined lives.

------
madaxe_again
Holmes and her crew are scanners and fabricators - and while I'd love to say
they'll get their comeuppance, they're now wealthy enough to buy their way out
of anything.

It's junk science, has been since day zero. Her father's USAID connections
make me think there's more going on here, and that they failing could embarass
elements in government.

~~~
judk
Also the fact that the CEO/"founder" hasonly one year of college as relevant
experience. She appears to be a pop star persona: a face to send to interviews
to look cool in PR, fronting for the business machine in the back. And of
course there was never any tech, just hopes they ride a hype was into winning
Quest's contracts.

------
littletimmy
Can someone point out to me what exactly it is that Theranos does?

My understanding was that this company administers innovative ultra-small
volume blood testing. Now they say that only works for the HSV-1 test (that
nobody wants, and by some accounts already existed), and for the rest of the
240 tests they use normal lab procedure.

What is the great innovation here? What is it that this company has been doing
for 10 years? Why is it worth $10B?

~~~
TazeTSchnitzel
It's not just these small vials of blood. They also make their own
"revolutionary" testing equipment, which they used for dozens of tests. Except
it turns out their equipment was giving quite badly inaccurate results, so
they quietly switched to conventional machines. Ditto for the small blood
vials.

~~~
littletimmy
So it's a flop, basically? That's a pity. They should just come clean; people
will respect them for it.

~~~
TazeTSchnitzel
It would be the honest thing to do, but I doubt it's the ideal for investors.

------
akhilcacharya
How do you even get funded without a process that is fully tested? Was this a
failure of due diligence? I don't understand.

~~~
jbigelow76
_How do you even get funded without a process that is fully tested?_

A fully tested process? Surely you jest. Hell, you don't even need to have an
idea to get funded[1].

[1][http://old.ycombinator.com/noidea.html](http://old.ycombinator.com/noidea.html)

~~~
Jack000
Since this is no longer an option I assume that experiment didn't go well. I
wonder what ideas came out of that group, a post mortem would be interesting.

~~~
mcintyre1994
This would definitely be interesting. There's a UK accelerator, Entrepreneur
First [0] which takes people pre-team and pre-idea. I'm not sure if they have
any exits yet, but YC occasionally fund their alumni.

[0] [http://www.joinef.com](http://www.joinef.com)

------
itsoverjohnny
Didn't anyone (really) check before putting money at a $10 Billion valuation??

~~~
csours
While I was still at HP, they bought a company called Autonomy for 11B
USD.[1][2] No one ever knew what they did. HP wrote off 9B USD in 2012.

1\.
[https://en.wikipedia.org/wiki/HP_Autonomy](https://en.wikipedia.org/wiki/HP_Autonomy)

2\. [http://www.marketwatch.com/story/the-mysterious-case-of-
hewl...](http://www.marketwatch.com/story/the-mysterious-case-of-hewlett-
packards-autonomy-deal-2014-08-19)

~~~
eitally
Autonomy did a lot of hand waving ...

but at the end, they did a decent job specializing in electronic records
management & e-discovery / litigation holds. Not nearly enough to justify the
ludicrous price, but at the time HP was desperate for something to help them
compete in any sort of "big data" market.

~~~
csours
I also question HP's decision to announce their entry in the cloud market via
the Onion [1]

1\. [http://www.theonion.com/video/hp-offers-that-cloud-thing-
eve...](http://www.theonion.com/video/hp-offers-that-cloud-thing-everyone-is-
talking-abo-28789)

------
apetresc
I don't understand the intricacies of FDA approval so I might be confusing
things here, but why is Theranos' front page currently claiming "Theranos
Receives FDA Clearance"?

------
rokhayakebe
1) Can we have a document from other visits to similar labs for comparison.

2) What does the $10B valuation people keep referring to has to do with
anything? If they do not meet requirements should they be valued less? This
does not make sense. If you do not meet standards for xyz, you shouldn't be
allowed to perfom xyz. The feedback should not be around the valuation.

3) The same press that are knocking Theranos are the same press that were
calling it disruptive. If anyone is to be blamed it should be them, and the
government agencies that allowed testing.

~~~
achow
For discussion sake I’m going to throw this out - The $10B valuation is the
ONLY issue here.

We know that for all the test except one, Theranos uses usual diagnostic
devices (from Siemens etc.) like any other diagnostic lab. So it will be
something like ~99.9% of their tests are done on traditional devices. So we
can safely assume that those tests are as reliable as those from other labs.

So if they are same as any other legacy industry for 99.9% of the time, then
why such a big valuation?

They should be valued same as their nearest rival (which I’m sure is a giant
compared to Theranos), and if adjusted for the fact that whether Theranos is
going to upset them without any secret sauce (and with fewer resources) then
the valuation should be near to $0.

~~~
sakai
Well, the troubling thread here is that _that may not be posssible using the
amount of blood Theranos collects_. Then the question becomes not only why is
their valuation so high (which the public doesn't need to care too much about)
but "how well do these traditional tests work with Theranos samples?"

That the answer could be "not very well" (and we haven't heard otherwise) is
what's most troubling to me.

~~~
hga
_Well, the troubling thread here is_ that that may not be posssible using the
amount of blood Theranos collects.

It's say it's worse. I followed up on the general impression they were
proposing to do this all with fingersticks, e.g. this citation from
Wikipedia's introductory paragraph published in 2013:
[http://www.wsj.com/news/articles/SB1000142412788732412300457...](http://www.wsj.com/news/articles/SB10001424127887324123004579055003869574012/)

Based on my general knowledge of biology and medicine, I'd expect there would
be a whole bunch of things you can't test that way due to general
contamination from all the normal cells and their membranes that get punctured
in a finger stick. Lipid panels, for example. In fact, the large venous draws
normally taken, at least for the first tube, could be in part to swamp the
contamination that comes from getting the needle into the vein in the first
place.

Per other discussions, they're now using their own technology only for HSV-1
tests, which are PCR based and therefore require only a _tiny_ sample, and the
above sort of contamination would not be an issue.

~~~
achow
Agree, and to your point I have read and watched most of the latest interviews
given by Holmes. In no place she claims that Theranos is using blood collected
in nanotainers (non-venous blood or finger prick blood) for assay (component
detection) using traditional diagnostic equipments.

Theranos uses non-venous blood for their proprietary tests (currently only 1
test) and rest 99.9% (figuratively speaking) tests uses venous blood in
traditional diagnostic equipment.

Back to the same question - If almost all of their tests are done using
traditional equipments, then why $9B valuation?

~~~
JoeAltmaier
Seem overvalued. But valuations are on future value. So if they could get
their test through the mill, what would they be worth? Multiply by your
estimate of their chances. Probably << $9B

------
thrownaway2424
Are the participants in Theranos' 2014 private equity sale even publicly
known? The list could be a source of amusement for many. Most amusing outcome
would be if DFJ, Ellison, et al exited in that round.

------
iandanforth
Document numbers? Release dates? This seems more like red tape and nitpicking
rather than a substantive challenge to a technology. It's stories like these
that guarantee I would never try to start a company in biotech or recommend a
friend join one.

~~~
epistasis
Unit testing? Source control? Continuous integration? Code documentation?
Seems like red tape and nitpicking rather than substantive coding. It's
stories like that that guarantee that I would never try to start a company in
software or recommend a friend join one.

Just because standard practice seems unnecessary to you doesn't mean that it
doesn't exist for good reasons. To anyone in biotech or familiar with what can
go wrong with physical products, your complaints come across as ignorant.

~~~
Uhhrrr
I've worked at successful companies which did a terrible job at one or another
of those, and the customers didn't complain (or die). You can get away with a
lot more in software than you can in other disciplines, because in software
you can incorporate negative feedback relatively quickly.

------
redwood
I'm so cynical that I don't trust the FDA to not be looking out for
established medical industry players.

I'm not saying conspiratorial that this is all BS but rather that I'm
surprised there isn't some more skepticism considering disruption of
industries this big and regulated will never go easily.

I understand that folks believe the cult of disruption has blinded everyone in
this case and think that may well be true. still these issues highlighted by
the FDA sounds to me like any scrappy startup which has to cut some corners.
some of you will claim the sky is falling but I don't buy it. if there's
nothing to their tech then they will indeed collapse but these papers are not
enough to make that clear

------
transfire
is that the same FDA involved in this:
[http://science.slashdot.org/story/15/10/27/037234/the-
popula...](http://science.slashdot.org/story/15/10/27/037234/the-popular-over-
the-counter-cold-medicine-that-science-says-doesnt-work) ?

And this: [http://www.cbsnews.com/news/fda-corruption-letter-
authentica...](http://www.cbsnews.com/news/fda-corruption-letter-
authenticated-lawyers-start-your-engines/)

And this: [http://seattleorganicrestaurants.com/vegan-whole-
food/instit...](http://seattleorganicrestaurants.com/vegan-whole-
food/institutional-corruption-of-pharmaceuticals-how-FDA-cannot-be-trusted-
with-public-safety.php)

And this: [http://ceramics.org/ceramic-tech-today/biomaterials/gsk-
drop...](http://ceramics.org/ceramic-tech-today/biomaterials/gsk-drops-ball-
with-puzzling-us-release-of-sensodyne-repair-protect-sans-45s5-glass)

And this: [https://reason.com/blog/2013/11/25/fda-shuts-down-23andme-
ou...](https://reason.com/blog/2013/11/25/fda-shuts-down-23andme-outrageously-
bann)

Why anyone's first inclination would be to trust the FDA is beyond me. In
fact, this whole story has a fishy Denmark smell to it. Why for instance is
all dissenting opinion being down voted?

~~~
neuronic
Because some people understand why the FDA shut down 23andme and approve of
this decision.

Maybe if you would have linked the official statements of both organizations
rather than a "reason.com" blog link with opinionated bullshitting, then your
point might stand some scrutiny.

This and the fact that things have now shifted [1] because even if that
doesn't fill your sensational hunger, no, the FDA is not on a crazy trip to
stop personal genomics.

[1]
[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm)

~~~
transfire
"Because some people understand why the FDA shut down 23andme"

Oh, do you? How about you explain it then.

