Does anyone know if Theranos conducting tests outside of California? I thought I heard something about Nevada and maybe one other state?
NJ
Theranos Ran Tests Despite Quality Problems
61–70 of 70 posts
Re: Theranos Ran Tests Despite Quality Problems
#62Earlier quoted context omitted.
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 ?
https://en.wikipedia.org/wiki/Negligent_homicide
You don't have to mean for something bad to happen to get jail time. You're still responsible for your actions, intentional or not.
I'm not lawyer, so bear with me, but my lay understanding is that if it can be shown that they should have been aware of the quality and other issues regarding their results, they could be criminally negligent. Feel free to correct me.
Re: Theranos Ran Tests Despite Quality Problems
#63Earlier quoted context omitted.
Ha. Your answer was technically correct but completely useless. Implicit in Animats' question was when that whole process happens.
The FDA does not have the power to jail people. Determining whether the state has sufficient reason to incarnate individuals is responsibility of the justice system. People go to jail when a judge and or jury recon thats justified. The FDA will make its case when it believes it has one. Will anyone from a 10B startup go to jail ? Probably not, but we can schedule that for afternoon tea outrage.
Again, you're spouting Civics 101 answers here. I'm familiar with how the US justice system operates. The question isn't looking for that. The FDA obviously won't have an FDA Judge send people to FDA Jail after they've been arrested by the FDA Police. Literally nobody here thinks that.
But they do initiate investigations, and it is a crime to defraud or attempt to defraud the FDA. And if the FDA so chooses, they can forward their information to Justice and participate in the proceedings against the accused. They could provide the evidence of wrongdoing and increase the political pressure to act. They can do a lot to ensure that the state determines it has sufficient reason.
Re: Theranos Ran Tests Despite Quality Problems
#64Earlier quoted context omitted.
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.
Past experience with industrial accidents is that fines for safety violations resulting in death is a few ten thousand dollars. No one goes to prison ever, even if the omissions that caused the incident were grave. Here is a report on the fallout from an incident that caused four deaths and much head-shaking in the chemical engineering community: http://cenblog.org/the-safety-zone/2015/05/osha-fines-dupont...
With that background, your faith in the system is touching but unwarranted.
Re: Theranos Ran Tests Despite Quality Problems
#65Earlier 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…
I would expect there are already multiple attorneys preparing to file class action lawsuits against Theranos (and Walgreens) on behalf of impacted lab test customers. The attorneys are probably searching for a suitable lead plaintiff right now. It's not necessary to prove that the patients were medically harmed by bad lab tests, just that they didn't receive the promised service. Theranos will probably settle to avoid an ugly trial, the lawyers will pick up a quick few million $, and the class members will get tiny partial refunds.
Re: Theranos Ran Tests Despite Quality Problems
#66The 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.
Not necessary. I worked in the medical device field for many years, writing software to control instruments that tested blood (serum).
The instruments can be trusted.
If a test is borderline, either the lab tech will manually retest it, or some instruments can be given business rules like "if result is on the threshold of good/bad, automatically rerun the test and provide both results to the physician."
We were well aware that the software we wrote affected real people's lives and acted accordingly. These idiots are only giving the rest of us a bad name.
Re: Theranos Ran Tests Despite Quality Problems
#67Earlier quoted context omitted.
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 ?
Are you seriously asking if negligence causing an accidental death can lead to prison? Think people dying when a building in disrepair burns.
Are you seriously suggesting negligence can be construed as acting in good faith ?
Re: Theranos Ran Tests Despite Quality Problems
#68Earlier quoted context omitted.
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 ?
https://en.wikipedia.org/wiki/Negligent_homicide You don't have to mean for something bad to happen to get jail time. You're still responsible for your actions, intentional or not. I'm not lawyer, so bear with me, but my lay understanding is that if it can be shown that they should have been aware of the quality and other issues regarding their results, they could be criminally negligent. Feel free to correct me.
I'm not a lawyer either. And being responsible for your actions certainly seems reasonable to me. But I cannot see how you could have acted in good faith if you were aware of quality and other issues regarding your result. That would be acting in bad faith.
Re: Theranos Ran Tests Despite Quality Problems
#69Earlier quoted context omitted.
You could reduce your accuracy by doing three tests of the same blood sample (of course, exposing yourself to the risk that the blood was taken incorrectly, was stored in an incorrect vessel, was transported incorrectly, etc...). In terms of practicality/Insurance - this would mostly be a function of how absolutely certain we are that the tests are accurate, and how damaging incorrect results would be. If we are 99.9…
That's not how healthcare economics works in the real world. No one can quantify the chance of death due to an incorrect test result precisely enough to calculate when it's cost effective to perform multiple redundant tests. The supporting data doesn't exist and no one is going to fund the research to figure it out. And what does 'incorrect' even mean? There is always some margin of error. In real medical practice if…
It's certainly how healthcare economics works. It determines what, if any tests should be run. It also determines how many parties/independent reviews should take place for high stakes tests such as tumor identification in carcinoma.
Other high-stakes scenarios in which the same tests are run multiple times are for high-economic cost events such as drug abuse, either in the workplace, or in sports.
You even note in your response, that, In real medical practice if a physician sees a lab result that is way out of range, or significantly different from the patient's previous result, or inconsistent with other aspects of the patient's condition, then she will order a repeat of the same test in order to confirm the results. - which is exactly what I'm suggesting people have done - only with a (presumably acceptable) time delay between when the first, and later tests are required. If the results of such tests were that clinical activity had to take place quickly, then you might not have the luxury of a delay, and in which case, multiple independent test vectors would be very useful - if they were economically feasible.
What people sometimes fail to consider - if the test was worth doing once - at, say, $600 - then why wouldn't it be worth doing (at presumably much higher confidence), three times at $100? And, if people agree, "OK, for $600 and $100 that makes sense" - they have to understand, those two numbers are completely arbitrary, and can only be understood in relationship to the value of the results. Whose to say there aren't a ton of tests today that are "$100" - that couldn't be done multiple times to be certain.
Re: Theranos Ran Tests Despite Quality Problems
#70I'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…
A company offering medical services that pose "immediate jeopardy to patient health and safety" deserves scrutiny. If they knew that their results weren't good and didn't act on that information, why should they ever be trusted in the future?
This illustrates my point. How does holding a drop of someone's blood in a lab pose "immediate" jeopardy to patients? They're in the trial phase, right? These tests are not yet being used to determine actual medical outcomes. What's wrong with trial and error in the trial phase? It's like PCI compliance. Who cares if your company doesn't pass PCI certification the first time (no one? You're given a long amount of time to fix PCI compliance issues).