This all sounds spectacular i just wonder why it's only WSJ that is doing all the reporting for them.
Theranos Ran Tests Despite Quality Problems
41–50 of 70 posts
Re: Theranos Ran Tests Despite Quality Problems
#42At what point here do people go to jail? The FDA can and has done that for faking lab tests.[1][2] [1] http://www.nytimes.com/1983/10/22/us/3-ex-officials-of-major... [2] http://pubs.acs.org/subscribe/archive/tcaw/10/i11/html/11reg...
At no point. They go into politics, charges if any are ever bought will just sort of fade away. These are rich powerful people, they don't go to jail.
I smell communism :|
Re: Theranos Ran Tests Despite Quality Problems
#43I've never seen so much scrutiny over a company before. Everyone is screaming "death to Theranos" at every opportunity. How much of that is purely balking over the high valuation? I have a feeling if they didn't raise so much money then journalists wouldn't be swarming this at all. All of the critiques I see don't seem even close to show stoppers. No public peer reviewed studies? Some lab updates to match FDA regulat…
As the other comments have stated - this isn't about valuation. This is a medical company that can, and probably has already, endangered patients' lives through its failings. There is a reason why certain industries are scrutinized so closely because of the effect they can have on people. Being in those industries, even as a startup, means you must follow the rules. Or are you fine with your doctor using some "unauth…
>Or are you fine with your doctor using some "unauthorized" random equipment the next time you need critical tests or surgery?
Hm. In that case I guess we would have to ask the question -- how legitimate does the eBay site look?
Re: Theranos Ran Tests Despite Quality Problems
#44Key takeaways from this new article, for people blocked by the WSJ paywall: "That letter cited “deficient practices” in five categories. In one of them, hematology, the problems found by inspectors posed “immediate jeopardy to patient health and safety,” regulators said. The test that inspectors found Theranos kept doing despite the erratic quality-control results was a hematology test that measures how long it takes…
That is rather scary. Quality control is a serious requirement to any competent lab. With physicians making decisions by results labs transmit, there is an inherent need of verifiable trustworthiness to the results. A patient may be subjected to life altering medication or treatments, which is not a trivial responsibility that can be shrugged off with erratic processes or lack thereof. A lab director's responsibility…
It makes me wonder if Theranos's inaccurate results have killed anyone. It's not unlikely.
Re: Theranos Ran Tests Despite Quality Problems
#45The key takeway I have from all this is if you are relying on Blood Tests for data that is critical to your health (as opposed to informative, educational, or personal interests) - it's probably a good idea, if you can afford it, to get results from three completely separate diagnostic systems - kind of like time with ntpd.
If none of the three tests is calibrated and traceable to a standard you are just as well off throwing darts at a board and getting your numbers out of that. Take personal responsibility for your health and your bank account by throwing dice!
It's really funny how people have stopped hating on the FDA when Theranos is mentioned. In any other context the FDA is still worse than Satan and the pox.
Re: Theranos Ran Tests Despite Quality Problems
#46At what point here do people go to jail? The FDA can and has done that for faking lab tests.[1][2] [1] http://www.nytimes.com/1983/10/22/us/3-ex-officials-of-major... [2] http://pubs.acs.org/subscribe/archive/tcaw/10/i11/html/11reg...
When they have been found guilty in a court of law ?
But who has standing to sue? Whoever suffered a stroke because their warfarin dose was too high or too low is dead, they cannot sue any longer. Whose dose was accidentally correct or whoever was lucky enough not to suffer a stroke did not suffer harm, so they can't bring suit either.
And Holmes and the board believed in good faith that their prothrombin test was accurate. No mens rea, no culpability. No prison for anyone.
Re: Theranos Ran Tests Despite Quality Problems
#47Earlier quoted context omitted.
When they have been found guilty in a court of law ?
But who has standing to sue? Whoever suffered a stroke because their warfarin dose was too high or too low is dead, they cannot sue any longer. Whose dose was accidentally correct or whoever was lucky enough not to suffer a stroke did not suffer harm, so they can't bring suit either. And Holmes and the board believed in good faith that their prothrombin test was accurate. No mens rea , no culpability. No prison for a…
The government always has standing for criminal cases (the only kind that involve jail) because the offense is against society. The families of a deceased person has standing to sue in a civil case. Any one who had a test run by the company has standing to sue as well, even if there was no harm - they did not receive the product that was advertised, namely a validated test.
I doubt this will result in jail time for the principles, but they should be expecting lawsuits over this.
Re: Theranos Ran Tests Despite Quality Problems
#48Earlier quoted context omitted.
When they have been found guilty in a court of law ?
But who has standing to sue? Whoever suffered a stroke because their warfarin dose was too high or too low is dead, they cannot sue any longer. Whose dose was accidentally correct or whoever was lucky enough not to suffer a stroke did not suffer harm, so they can't bring suit either. And Holmes and the board believed in good faith that their prothrombin test was accurate. No mens rea , no culpability. No prison for a…
The estate/heirs of the deceased have standing.
And, there should be some civil remedy that costs Theranos big-time. Massive fines, one-site FDA overseers, etc.
That said, I don't think I'll be sending my bloodwork to Theranos any time soon. That's some scary stuff.
Re: Theranos Ran Tests Despite Quality Problems
#49I've never seen so much scrutiny over a company before. Everyone is screaming "death to Theranos" at every opportunity. How much of that is purely balking over the high valuation? I have a feeling if they didn't raise so much money then journalists wouldn't be swarming this at all. All of the critiques I see don't seem even close to show stoppers. No public peer reviewed studies? Some lab updates to match FDA regulat…
This is a new company, why should these be the doomsday callings?
Theranos is NOT a new company. They've been around for more than a decade.
This isn't the latest and greatest dating app. This is medical tests that have a very real impact on the treatment provided to patients.
Re: Theranos Ran Tests Despite Quality Problems
#50Earlier quoted context omitted.
When they have been found guilty in a court of law ?
But who has standing to sue? Whoever suffered a stroke because their warfarin dose was too high or too low is dead, they cannot sue any longer. Whose dose was accidentally correct or whoever was lucky enough not to suffer a stroke did not suffer harm, so they can't bring suit either. And Holmes and the board believed in good faith that their prothrombin test was accurate. No mens rea , no culpability. No prison for a…
The federal agency tasked with that responsibility I would naively presume, or do you prefer trial by media ? And why, exactly, would someone that acted in good faith deserve prison ?