
U.S. Probes Theranos Complaints - jerryhuang100
http://www.wsj.com/articles/u-s-probes-theranos-complaints-1450663103
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seehafer
What's notable about the meat of the complaint sent to the FDA is that it's
less "this technology actually doesn't work" and more "this company has no
culture of experimental integrity".

From the article:

"hadn’t fully assembled the proprietary machines used for the herpes study
when the experiments began" ... "company underreported the rate at which the
machines broke down during the study" ... "employee also alleged that some
crucial parts of the devices ... were modified to improve their accuracy"

FDA is generally skeptical of validation data not generated from "production
equivalent" technology, but they get even more skeptical if you tell them
something is X and it turns out to be Y down the road. That (rightly) sends
them on a fishing expedition.

~~~
Shivetya
really sounds if they went to certification's stage too early, regulatory
bodies do not tend to support rapid iteration of products

~~~
revelation
The company is already 12 years old.

~~~
Shivetya
I fully understand that part, perhaps the FDA needs to adapt as well. Testing
doesn't need to be static, there is room for cooperative certification and
corrective actions to insure the test completes. With the rapid advances in
some areas of technology you could run into a situation where you obsolete the
technology you are working on as certification issues reveal improvements.

While the medical field certainly has additional concerns I do see a time
where, with proper processes in place, that the final delivery may not exactly
be what entered the certification phase.

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Jerry2
> _Edison machines would sometimes produce “radically different results” for
> the same patients, the former employee alleged. Referring to a thyroid test
> known as thyroid-stimulating hormone, the employee wrote that “a patient
> would swing between” hypothyroidism and hyperthyroidism, or too little of
> the hormone and too much, when the test was repeated the same day._

This sounds really bad. When you have this huge amount of uncertainty in
results, it calls into question their whole finger prick blood sampling
methodology. I'm starting to think that it's impossible to get an accurate
blood work from a finger prick only.

~~~
danieltillett
>I'm starting to think that it's impossible to get an accurate blood work from
a finger prick only.

It is possible, but just for certain test types and error rates. The basic
problem is the blood drawn from a finger prick is affected by exactly where it
goes in and how much skin tissue is picked up. This variability gets averaged
out with a large venous draw and so is not quite as bad - there is still a
large variability with even normal blood tests for certain test types.

The tests that work OK are things where you just want a yes/no answer (do you
have HSV1) and very poorly for things where you are wanting to measuring exact
levels of something.

None of this is new to the industry.

~~~
raverbashing
I wonder if they can detect the level of known impurities and correct for
that.

If the issue is skin contamination, measure the level of some substance that
is correlated with that contamination, then apply a correction factor

~~~
danieltillett
I assume that is what they hoped to do. Lots of people with decades of
experience in this area have tried to do this before without too much success.
This doesn't mean it is impossible, but if you are claiming to be able do
something that everybody else has tried and failed then your data needs to be
impeccable. No hiding behind trade secrets and saying trust us.

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seibelj
Compared to the other theranos article on top of HN right now, this one is far
more damning. The whistle blower is claiming that even the herpes test, the
only test the FDA has approved, had its results altered in some way to pass
the FDA's requirements. If this is true, what does theranos even have left?

~~~
danieltillett
But I was told herpes is forever?

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mmaunder
To bypass the paywall:
[https://www.google.com/search?q="http%3A%2F%2Fwww.wsj.com%2F...](https://www.google.com/search?q="http%3A%2F%2Fwww.wsj.com%2Farticles%2Fu-
s-probes-theranos-complaints-1450663103")

~~~
vive-la-liberte
Didn't help.

>To Read the Full Story, Subscribe or Sign In

~~~
mmaunder
Strange. Worked for me after I was blocked, same browser. I wonder if you're
using Tor, or if they're geotargeting the way they handle google referrers. Or
perhaps you're coming from a google.co.XX domain instead of google.com?

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swingbridge
The reason for taking larger samples on many tests using "normal" methods is
not that the instruments are not sensitive but that one needs to draw enough
blood to get a representative sample of what's actually inside your body. A
little prick of blood that comes out is often not such a representative
sample. I always wondered how Theranos was going to get around this fact of
life. Now as things unfold it increasingly sounds like they can't... they just
wanted us to think they could.

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jonknee
I predict Theranos will be out of business within 18 months. It's a vaporware
company with a cult of personality founder. Hard to pull off with increased
media exposure, even harder to pull off with regulatory agencies looking into
you.

Update: too bad Theranos isn't publicly traded, I'd love to be able and bet
against them.

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FussyZeus
So we have a 12 year old company here, developing a machine to test blood
(which is altered for testing), has only received approval for one test, which
is now being doubted again, has repeatedly lied about their technology and
capability.

I don't give one sordid fuck about Holmes, let's talk about Theranos. How is
this a successful business in ANY capacity? Has it made a DIME that didn't
come from an investor? Does it have ANY reputation that doesn't involve a
spunky CEO?

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tronreg
Has Theranos broken the law?

~~~
seehafer
Falsifying data to obtain regulatory approval is definitely illegal, and
federal regulations allow the government to hold corporate officers personally
liable.

It has yet to be proven that Theranos did in fact falsify data, though.

~~~
w1ntermute
Given how things are looking right now, Elizabeth might want to start
preparing a shipment of orange turtlenecks to be delivered to her in the big
house.

~~~
danieltillett
She is very well connected. I will not be surprised if she walks away from the
mess in black and not orange.

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jenshoop
So conflicted about all of the rage and drama around Theranos. On the one
hand, it smacks of the conventional backlash against solutions that
revolutionize the way things have been done forever, and there needs to be
space for innovators to work through kinks to really bring an idea to market.
On the other hand, it sounds like this product does not work (or does not yet
work well) and it's not the kind of solution space where errors can be brushed
off lightly.

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peter303
The complaint was a former employee. That gives me some reservations as about
the motive.

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gamesbrainiac
Thought I'd put this in here:
[https://www.youtube.com/watch?v=rGfaJZAdfNE](https://www.youtube.com/watch?v=rGfaJZAdfNE)

This is EH's response to the WSJ article. Very positive defence of EH. Just
wanted to add this for an alternative take.

~~~
swingbridge
Well, let's see how she responds to this Federal investigation that
essentially accuses her of being a fraud. If her company really did fudge FDA
testing results then that's beyond bad.

