5 ms·

Theranos Halts New Zika Test After FDA Inspection

78 points by dankohn1 10y ago

zitterbewegung 10y ago
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 10y ago
  Lobbying money? Who knows...
  - kelvin0 10y ago
    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 ...
arcticfox 10y ago
Brutal mistake, it sounds like their product probably actually works in this case too but they just can't follow the rules.
dhruvrrp 10y ago
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
- minimaxir 10y ago
  There's a big difference between a grudge and a where-there's-smoke-there's-fire scenario.
- deleted 10y ago
  [deleted]
- deleted 10y ago
  [deleted]
- bsder 10y ago
  > 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”
- sseveran 10y ago
  I don't think there needs to be malice here. They do need to sell newspapers and Theranos cultivated a high profile media image so people are interested in them.
masterjack 10y ago
“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 10y ago
  And in other news, their general counsel stepped down.
samplonius 10y ago
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 10y ago
  > 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-diagnostic-testing-technologies-american-association-clinical-chemistry-meeting/ https://news.theranos.com/2016/08/02/theranos-unveils-diagno...
JoeAltmaier 10y ago
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.
- rayiner 10y ago
  First, do no harm.
- hprotagonist 10y ago
  Not quite. 1. Their tech is _deeply_ unproven. Theranos doesn't even use it internally, and the sanctions against them in the past year have been very instructive about that. They have exactly zero publically disclosed, peer-reviewed pieces of evidence that detail the clinical use and efficacy of their primary technology. 2. Thou Shalt have an IRB [0]. No exceptions. The tuskegee experiment[1] and other utter failures of medical ethics in this country is why. [0]: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/ http://www.hhs.gov/ohrp/regulations-and-policy/regulations/4... [1]: https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment
  - _asummers 10y ago
    IRB, for those like me who didn't know, stands for institutional review board.
  - rblatz 10y ago
    It's such a basic mistake that I can't imagine any legitimate researcher making it. I helped out with a project that anonymously surveyed registered dietitians about their knowledge of listeria. It had to go to through the IRB before we started, and then any change to it required an IRB amendment. It is unbelievable how big and how basic of a mistake they made, it makes me question what other corners they cut.
    - hprotagonist 10y ago
seesomesense 10y ago
" 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.

78 points by dankohn1 10y ago

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 10y ago
Lobbying money? Who knows...
- kelvin0 10y ago
  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 ...

arcticfox 10y ago

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

dhruvrrp 10y ago

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

minimaxir 10y ago
There's a big difference between a grudge and a where-there's-smoke-there's-fire scenario.
deleted 10y ago
[deleted]
deleted 10y ago
[deleted]
bsder 10y ago
> 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”
sseveran 10y ago
I don't think there needs to be malice here. They do need to sell newspapers and Theranos cultivated a high profile media image so people are interested in them.

masterjack 10y ago

“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 10y ago
And in other news, their general counsel stepped down.

samplonius 10y ago

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 10y ago
> 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-diagnostic-testing-technologies-american-association-clinical-chemistry-meeting/ https://news.theranos.com/2016/08/02/theranos-unveils-diagno...

JoeAltmaier 10y ago

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.

rayiner 10y ago
First, do no harm.
hprotagonist 10y ago
Not quite. 1. Their tech is _deeply_ unproven. Theranos doesn't even use it internally, and the sanctions against them in the past year have been very instructive about that. They have exactly zero publically disclosed, peer-reviewed pieces of evidence that detail the clinical use and efficacy of their primary technology. 2. Thou Shalt have an IRB [0]. No exceptions. The tuskegee experiment[1] and other utter failures of medical ethics in this country is why. [0]: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/ http://www.hhs.gov/ohrp/regulations-and-policy/regulations/4... [1]: https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment
- _asummers 10y ago
  IRB, for those like me who didn't know, stands for institutional review board.
- rblatz 10y ago
  It's such a basic mistake that I can't imagine any legitimate researcher making it. I helped out with a project that anonymously surveyed registered dietitians about their knowledge of listeria. It had to go to through the IRB before we started, and then any change to it required an IRB amendment. It is unbelievable how big and how basic of a mistake they made, it makes me question what other corners they cut.
  - hprotagonist 10y ago

seesomesense 10y ago

" 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.