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Theranos Ran Tests Despite Quality Problems
- Animats 11y agoAt 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-laboratory-convicted-of-falsifying-drug-tests.html http://www.nytimes.com/1983/10/22/us/3-ex-officials-of-major... [2] http://pubs.acs.org/subscribe/archive/tcaw/10/i11/html/11regs.html http://pubs.acs.org/subscribe/archive/tcaw/10/i11/html/11reg...
- ageofwant 11y agoWhen they have been found guilty in a court of law ?
- function_seven 11y agoHa. Your answer was technically correct but completely useless. Implicit in Animats' question was when that whole process happens.
- ageofwant 11y agoThe 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.
- function_seven 11y agoAgain, 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.
- HarryHirsch 11y agoBut 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.
- mbreese 11y agoThe 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.
- alistairSH 11y agoThe 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.
- HarryHirsch 11y agoPast 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-for-methyl-mercaptan-deaths/ http://cenblog.org/the-safety-zone/2015/05/osha-fines-dupont... With that background, your faith in the system is touching but unwarranted.
- ageofwant 11y agoThe 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 ?
- seehafer 11y ago>At what point here do people go to jail? Generally the FDA will give companies several outs to fix problems, they only bring out the handcuffs after several ratcheting steps (one of which includes bringing in a US Marshal and a team from the FDA, at your expense, to be at your business every day and tell you how to run your company).
- madaxe_again 11y agoAt 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.
- mlvljr 11y agoI smell communism :|
- Asparagirl 11y agoKey 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 blood to clot, the people familiar with the matter said. The test is an important part of the treatment regimen for patients who are at risk of strokes or have blood disorders... People who have seen the Theranos inspection report said it seems to indicate the company ignored quality-control results for the blood-clotting test that fell short of its own criteria. The results produced in the quality-control checks repeatedly deviated from the lab’s typical result by more than two standard deviations, those people said... At Theranos, there were seven quality-control failures in a single day, said a person familiar with the report... Dr. Hamill said any doctors who received prothrombin time test results from the Theranos lab during the six-month period shouldn’t rely on them and should have their patients retested as soon as possible. “Those results are not worth anything,” he said... The federal inspectors also concluded that the Theranos lab in California used expired reagents, or substances added to blood samples to elicit chemical reactions, for some prothrombin time tests, according to the people familiar with the inspection report. Those people said the report also found that the lab’s director didn’t have responsibility for the lab’s quality-control program and the lab’s quality-control manager was unqualified..." EDITED TO ADD: Actually, the really key sentence is this one: "Theranos spokeswoman Brooke Buchanan said: “The PT/INR issues identified by CMS related to tests run on conventional equipment using venipuncture samples.” A CMS spokeswoman declined to comment." Because that means that these quality control problems were not due to Theranos' "revolutionary" finger-prick tests, they were from regular old venipuncture tests running on a standard machine that were giving wildly incorrect results, expired reagents, no QC in the lab, etc. Bad data is worse than no data. If they couldn't get old-fashioned labs right, no wonder they were having trouble with the finger-prick stuff.
- cordite 11y agoThat 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 includes ownership of quality processes, reviewing abnormal results after the fact to see if proper processes were followed (such as communicating with the respective provider), reviewing financial success, and much more. To shrug off quality control and operate as if reputable is not just unethical, but incompetent. Such operations should cease immediately. Disclaimer: I have experience in the medical lab industry.
- daveguy 11y agoDoes anyone know if Theranos conducting tests outside of California? I thought I heard something about Nevada and maybe one other state?
- seehafer 11y agoArizona.
- jonwachob91 11y agoNJ
- orionblastar 11y agoAlternate text on Pastebin here: http://pastebin.com/CqwL0iHR http://pastebin.com/CqwL0iHR No images but it has the full text of the story. WSJ has a paywall for subscribers.
- progers7 11y agoI don't think we want to be a community that shares content like this.
- striking 11y agoEver wondered what the "web" link was for? It Googles the link title. Accessing via Google gets around the paywall. I agree that this post is ethically dubious, but at the same time we actively bypass the paywall anyway.
- minimaxir 11y agoThe Google workaround no longer works for the WSJ.
- cft 11y agoI'd be very curious to know if it actually increased WSJ subscriber revenue? Because I doubt it decreased their hosting bill.
- striking 11y agoHuh. Could have sworn it worked, I honestly tested it. Whatever, the same news is available elsewhere anyway. The Web button does that too.
- ascorbic 11y agoWorked for me just now.
- orionblastar 11y agoIt still works if you use some plugins to set the user agent to Googlebot and other things to trick the WSJ into thinking you are from Google. Sometimes searching the title in Google works, sometimes it does not. I'm really against paywalls because it is discrimination against the poor. It is like having a pay bathroom.
- stevebmark 11y agoI'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 regulations? Using some "unauthorized" third party equipment? This is a new company, why should these be the doomsday callings? I have no idea if Theranos will succeed, but I can't shake the feeling that this media response is inflated due to the high valuation, and journalists are falling victim to the hype as much as the public, whereas this is a fairly normal health startup otherwise. It probably was a mistake to accept such a high valuation, so I don't think Theranos is totally innocent here. It's also strange that a paywall article made it to the front page? I wouldn't guess there's a big overlap of WSJ subscribers and HN readers (lol conspiracy).
- bronson 11y agoAnd how much of that is due to Theranos being a medical company? You need to play a clean game when lives are at stake.
- saalweachter 11y agoDerailing, that's my biggest ":-/" with the Silicon Valley start-up "move fast and break things" culture. If we as software engineers want to work on problems that matter, and not just dating apps and ad networks, we can't have a work ethic that encourages us to ignore troublesome laws and regulations and launch half-baked MVPs with a plan to maybe fix problems as they arise in future iterations. Sure, work smart, automate all the boring shit, but your automation has to be correct. Sure, focus on a MVP to get off the ground -- but make sure your product is viable, and correct across the minimum set of features. Even when we are working quickly, sparsely, we should be laying good foundations for the future. We shouldn't be lazy conmen selling poisonous snake-oil.
- Bud 11y agoCompletely wrong. How far down do you have to read in this article to find Theranos' valuation? All the way. It's not there. At all. Nobody really gives a fuck about the valuation except valuation wonks. But a lot of people care a lot about this woman being a complete charlatan who is endangering public health.
- ghshephard 11y agoThe 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.
- nradov 11y agoNot practical for most patients in the real world. Insurers won't pay for redundant lab tests. Getting blood drawn multiple times is painful and logistically difficult. For patients with clotting problems just getting blood drawn presents some risk. And there often won't be 3 independent labs in the patient's area.
- ghshephard 11y agoYou 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 99.99% certain the values are correct, and incorrectly results wouldn't result in irreparable harm - then yes, not worth the investment in redundant lab tests. But, if there is, say, a 5% chance I might die on an incorrect test result that has a 1% chance of happening - and that test is performed 12 times/year - then you can pretty quickly calculate the net-present-value of my life versus cost of test. (I.E. If I think my Life is worth $10mm, and the test normally costs $500 each time, or $6000/year, and I need to have this test done for the next 10 years, (assuming the value of my life doesn't drop over time, to make this simpler) - then each time I get the test there is a 1% chance of failure * 5% chance of death = 0.05% chance of dying as a result of each test. The odds of me dying then, in the next 120 test = 100%-(chance-of-not-dying-120-times-in-a-row) = 1-.9995 ^ 120) = 5.825% chance of dying in this scenario using tests that cost $60,000. If I could reduce that to 1% (4.825% reduction) chance by spending an extra $120,000 (perform the test in two extra labs) - then my my investment of $120k would return 4.825%*10mm = $482,500. You can work the numbers, assumptions, etc.. however appropriate - but for some combination of test costs, frequency, potential harm, and value assigned to life - there is quantifiable value that justifies performing the test multiple times (and, likewise, clearly circumstances in which, even if the test results are more likely to be inaccurate, not worth performing thee test). Not having access to multiple labs is a real problem though.
- yitchelle 11y agoJust starting to read up on this. Does anyone know if any of Theranos's customers used the lab results for ongoing medical treatment and suffered as a result of it?
- jorgecurio 11y agoThis is speculation but...the company was founded in 2003....13 years ago and no product out yet...I have an awful feeling Holmes felt desperate, took on more than she could chew in order to compensate for the decade she lost, and now all the shortcut taking is catching up to her.... It's starting to look very ugly for what started out as something overreaching, and I think she will fight even harder to keep the house of cards from falling but pretty much this unicorn will be the first to go in 2016.
- return0 11y agoThis all sounds spectacular i just wonder why it's only WSJ that is doing all the reporting for them.
- nkrisc 11y agoWell they certainly managed to "disrupt" something, like trustworthy lab results!
- thrillgore 11y agoI just want to know when the tell-all book will be released.