
Theranos – Statement of Deficiency from CMMS [pdf] - jerryhuang100
http://www.wsj.com/public/resources/documents/report20160331.pdf
======
Animats
What a mess. This has nothing to do with Theranos's "nano" technology. This is
about Theranos botching standard tests performed with standard commercial
equipment, and then not reporting their errors.

Much medical lab practice includes running known test samples through the
process regularly to check the test. They skipped a lot of that. Many things
can potentially go wrong. They did. Expired reagents, freezers at wrong
temperatures, failure to do regular maintenance, patient tests run on machines
that were reporting errors... Some of the technicians hadn't completed medical
technician training, but were doing complex tests. The summary: "Overall, over
21% of QC samples on all devices had values greater than 2 SDs". So many
results were way off, and they weren't catching that.

Those are for standard tests on standard machines. The results for Theranos'
"Edison" machine were worse. As in more than 10x more variation than standard
techniques.

This isn't even the FDA. This is the Center for Medicare Services checking up
on a company to which they paid a lot of money.

WSJ: _" “This is the first time that we’ve actually seen data from the
Theranos instrument, and it’s as bad as one would have worried it would be,”
said Stephen Master, associate professor of pathology at Weill Cornell Medical
College in New York. “Based on this data, it’s hard for me to believe that
they went live with this instrument and tested patient specimens on it.”_

 _" The inspection report said Theranos didn’t notify doctors treating
patients potentially affected by the erroneous results until mid-November, or
seven weeks after the inspectors first identified the problems."_

 _" The lab directors during the period of the survey no longer hold any
position within the lab. The new lab director..."_

This looks like the "move fast and break things" crowd trying to run a medical
lab.

~~~
linuxkerneldev
> This looks like the "move fast and break things" crowd trying to run a
> medical lab.

No, I don't think that's fair to the "move fast" crowd. This looks more like a
bunch of politically connected country club types trying to "brag" a startup.
Eg: Board of Directors = Henry Kissinger, former Secretary of Defense Bill
Perry, former Secretary of State George Shultz, etc.

These people are used to manipulating the system at the expense of the public
and getting away with it. I presume they expected to be able to achieve the
same with this as well.

~~~
joering2
> These people are used to manipulating the system at the expense of the
> public and getting away with it.

Quite heavy accusations -- anything substantial to actually prove it?

~~~
madaxe_again
Have you ever _heard_ of Henry Kissinger?! The man practically wrote the book
on realpolitik (although he didn't, von Rochau did)!

------
tyre
There is an accompanying article [1] that gives more background. The part on
there internal quality control tests show the tech just isn't there.

> The inspection report showed that 29% of the quality-control checks
> performed on the company’s proprietary blood-testing devices in October 2014
> produced results outside the range considered acceptable by Theranos.

> In February 2015, an Edison-run test to measure a hormone that affects
> testosterone levels failed 87% of quality-control checks, the report said.

It doesn't look like they are using Edison to run most of their tests, so we
can excuse the experimental tests if they aren't being used for actual
patients. Chalk that up to work-in-progress.

What is absolutely inexcusable is their treatment of patients, especially when
they found out that results were incorrect.

> Inspectors also found that Theranos sometimes released patients’ results
> even when the Edison devices used to run those tests produced erratic
> results in quality-control checks.

and

> The inspection report said Theranos didn’t notify doctors treating patients
> potentially affected by the erroneous results until mid-November, or seven
> weeks after the inspectors first identified the problems.

Seven weeks to notify customers that you may have fucked up a medical test? We
reach out to customers about __potential __software bugs within an hour.

This is an instance where I am glad to have government slowing down
innovation. "Move fast, break things" doesn't work when people's lives are at
stake.

[1]: [http://www.wsj.com/articles/theranos-devices-often-failed-
ac...](http://www.wsj.com/articles/theranos-devices-often-failed-accuracy-
requirements-1459465578)

~~~
diskcat
>"Move fast, break things" doesn't work when people's lives are at stake.

No matter what you do, people's lives are at stake. Even an app that suggests
which restaurant to go for dinner could cause somebody to die by suggesting a
restaurant in an area with higher rate of accidents.

The problem is how little consumers have control of when it comes to
healthcare. We like to hand wave and pretend that the rules of economics don't
apply when it comes to healthcare so instead of having a market where a person
can shop for medicine, doctor's service, equipment etc. it all is more or less
just close your eyes go in the tunnel and you will be taken care of and any
issue of choice with regards to money is occluded by 'universal healthcare is
a human right'.

If I could go to a hospital who would then give me a brochure of all the
equipments they use and I find out one of their supplier is a dodgy companies
that have dodgy equipments and terrible bug-handling practice I would go to
another seller just as I would a smartphone that uses a dodgy processor that
is known to break.

~~~
Dr_tldr
You don't think there might be a certain information asymmetry between you and
a medical care provider? And if there's not, why are you going to doctor at
all?

~~~
diskcat
There is an information asymmetry when I buy an apple at the farmer market.
That doesn't mean that every time I buy an apple I'm getting ripped off by the
seller.

~~~
Dr_tldr
If you feel the value of your life/health is essentially comparable in gravity
and scale to buying an apple at a farmer's market, your opinions on healthcare
regulation are unlikely to be relevant to very many people.

------
smaili
For those of us who aren't familiar, what exactly is the purpose of this
document and what does it mean for Theranos?

------
Fede_V
Out of curiosity: has anyone ever tried to do a correlation about the
performance of a hard-tech company vs the ratio of technical/political people
in their board of directors?

This is probably a strong prior on my part - but when I saw the composition of
the board of directors of Theranos (secretary of states/generals/congressmen
etc) I was immediately incredibly skeptical. It seems like the board was
chosen to provide lucrative contacts instead of actually useful advice and
supervision.

------
w1ntermute
Corresponding article: _Theranos Devices Often Failed Accuracy Requirements_

[http://www.wsj.com/articles/theranos-devices-often-failed-
ac...](http://www.wsj.com/articles/theranos-devices-often-failed-accuracy-
requirements-1459465578)

------
Aelinsaar
This... this is real train wreck. When this finally goes down, it's going to
happen so quickly, and I wouldn't be shocked if some people try to cut and
run, fleeing the country.

------
atonse
This is one of those rare times where my procrastination in applying for a job
at Theranos actually paid off. So grateful I avoided moving my family across
the country to get entangled in this mess.

------
godzillabrennus
Theranos is getting some well deserved regulatory attention.

We need better healthcare tech but we also need to know that it works.

------
niuzeta
They're all dated November of 2015, which was right around when the WSJ
investigation brought out. Is this the first time this document(s) was open
publicly? What is the new information here?

------
cant_kant
"In April and May 2015, a test to measure prostate-specific antigen, or PSA,
failed quality-control checks 22% of the time. The PSA test is used to help
detect prostate cancer."

Ouch.... I see a string of class action suits in the future.

------
c-slice
Although it seems like the acronym should be CMMS, it's actually CMS.

------
iskander
This is actually a lot worse than the results recently reported by Mount Sinai
in their comparison of a few dozen patients against two standard lab testing
companies. I wonder if Theranos has been trying to clean up their standard
tests.

------
brandon272
Is there any chance that any of the company's directors will see jail time
over this?

~~~
jonnathanson
Doubtful, unless they've got any extant political enemies who want to make an
example out of them. Theranos' BOD is basically a who's who of Washington
power brokers.

------
zavi
WSJ sure does not like Theranos.

~~~
URSpider94
It's a reporter with a juicy story. Just like with Woodward & Bernstein with
Watergate, someone smells a Pulitzer coming if they can single-handedly
trigger the collapse of a beloved unicorn.

~~~
nickgrosvenor
You're right, they're dead

~~~
URSpider94
That might be a little premature, but this team (primarily John Carreyrou and
Christopher Weaver) are clearly not going to stop writing about Theranos any
time soon. Additionally, they've pretty clearly provided an outlet for people
who seem to be itching for this story to get some sunlight, so they're
scooping the world on the blow-by-blow of Theranos' interactions with FDA,
Walgreen's, Safeway, etc.

