
Theranos Halts New Zika Test After FDA Inspection - dankohn1
http://www.wsj.com/articles/theranos-halts-new-zika-test-after-fda-inspection-1472598332
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samplonius
Click bait title?

Theranos withdrew their application to the FDA for the test. So "Theranos
Halts New Zika Test" is technically accurate, but it suggests that the test
was actually being performed.

~~~
w1ntermute
> a company news release[0] said Theranos had collected finger-stick blood
> samples from patients, including in the Dominican Republic, and run the
> tests on the new miniLab device, which showed that the Zika test worked.

From the news release:

> The company collected finger- stick samples from subjects, including in the
> Dominican Republic, and shipped those to Palo Alto to run on the miniLab.

0: [https://news.theranos.com/2016/08/02/theranos-unveils-
diagno...](https://news.theranos.com/2016/08/02/theranos-unveils-diagnostic-
testing-technologies-american-association-clinical-chemistry-meeting/)

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arcticfox
Brutal mistake, it sounds like their product probably actually works in this
case too but they just can't follow the rules.

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masterjack
“We hope that our decision to withdraw the Zika submission voluntarily is
further evidence of our commitment to engage positively with the agency,” said
Dave Wurtz, Theranos’s vice president of regulatory, quality and clinical
affairs.

~~~
firebones
And in other news, their general counsel stepped down.

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seesomesense
" FDA approval of the miniLab would allow Theranos to sell the device for
outside use even if she is banned from owning or running a lab for at least
two years."

Scary...

Would be very worried to see any Theranos device being used for anything that
impacts on clinical decision making..

Theranos needs to die and Ms Holmes needs to go back to university.

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zitterbewegung
How long until people go to jail? I don't see how Theranos can get out of this
downward spiral due to its attitude of disregarding laws and even ethics. If
they really want to help people they should try to do no harm first.

~~~
quickben
Lobbying money? Who knows...

~~~
kelvin0
You have people on the Theranos board of directors who have commited much
worse than what the company has been accused of recently. For example, Henry
Kissinger:

"In June 1999, by order of President Bill Clinton, the State Department
released thousands of declassified documents[79] revealing for the first time
that the CIA and the State and Defense Departments were intimately aware of
Condor"

Who is Henry Kissinger and what is Operation Condor?
[https://en.wikipedia.org/wiki/Operation_Condor](https://en.wikipedia.org/wiki/Operation_Condor)

If the architects of such chaos in Latin America have never been charged, I
don't think they ever will be. Of course the 'puppets' (Pinochet and other
cronies) got some form of 'justice' applied to them in recent years, but what
they got does not even amount to a slap on the wrist ...

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dhruvrrp
Wow another blow to Theranos. I'm surprised they are still in business.

On another note, someone in the wsj seems to really hold a grudge against
Theranos and/or Elizabeth Holmes.

Edit: Warren to Holmes mb

~~~
bsder
> On another note, someone is the wsj seems to really hold a grudge against
> Theranos and/or Elizabeth Holmes.

I suspect because they were, at one point, on the receiving end of her wrath.
She strikes me as a Carly Fiorina, Jr., and not even remotely above pulling
some contacts to exert some backhanded political pressure on people she
doesn't like.

Not all reporters are idiots. And some of the reporters who cover specific
areas are pretty close to experts in their own right. If you try to feed them
a line of bull, they're going to smoke you.

The relevant line is: “Never argue with a man who buys ink by the barrel”

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JoeAltmaier
So Zika, a devastating illness that is likely to cripple thousands, will go on
being undetected because Theranos _may have not quite followed the rules_ in
collecting finger sticks? This is a public health emergency. Appalling.

~~~
JoeAltmaier
And all of the responses and negativity skate around the positive results and
the tragic loss of an effective diagnostic procedure. Because 'rules'.

The oversight (potentially risking folks safety by not doing a finger stick
with the right paperwork?) has nothing to do with the actual medical test nor
does it compromise the results. Yet everybody is fine with punishing an
unpopular company because of yes technicalities. While public safety and the
lives of unborn children are at serious risk.

I don't get the nerd mentality sometimes. Common sense flies right out the
window.

~~~
apathy
Thalidomide was also banned in the US "because rules".

Common sense in medicine prioritizes doing no harm.

I can provide other notable examples if need be. The bottom line is that all
parties need to be confident that the expected benefit of a test or procedure
outweighs any expected potential harms. Having multiple layers or peer review
is one way to ensure this.

I work on clinical trials of "black label" (potentially lethal) agents in
patients that typically have no other options. Our pages can be 70-100 pages
and we are doing this in our "spare" time (Ha! Ha!). I don't think it's
unreasonable for a massively capitalized private company to produce
documentation at least up to this standard.

It really isn't much to ask, especially for an existential venture like this
(something -- anything! -- trustworthy to recover the tremendous amount of
credibility they've lost.)

Other companies had no problem writing a suitable protocol. Why should
peoples' safety be compromised just so that an untrustworthy company can enter
the market?

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JoeAltmaier
We're talking a finger stick here. And a devastating illness that is poised to
become a worldwide epidemic.

~~~
apathy
For which other diagnostics exist from companies that somehow managed to
submit a proper protocol.

Unlike Zika tests, it is extremely rare for patients in the trials I design to
have any alternatives. Also unlike Zika, the standard of care in the diseases
I work on yields less than 25% 5-year survival.

Not birth defects (horrific though they may be) but death from organ failure
and infection. Nearly all of the compounds are known or potential teratogens.
No alternative sources for most of the drugs. Still need an IRB.

You say, "oh it's just a finger stick!" To which I must say, have you looked
at the number of physicians and nurses who got Hep C or HIV from an errant
finger stick in the hospital?!

~~~
JoeAltmaier
And I come back again with "Mothers and babies and a worldwide epidemic"

