13 ms·
The letter the Feds sent to Theranos [pdf]
- bluker 11y agoFrom a funding standpoint the first question that comes to mind is, "How did this happen?" Theranos to date has raised $88.4M. The Series C was raised in 2010 following a 4-year hiatus. In the ten years since the founding of Theranos, they were unable to hire anyone who would help them figure all this shit out? It seems insane to me that a well respected venture firm like DFJ, who invested in their Series A,B and C, would not have done their due diligence and understood where Theranos would become vulnerable. Everyone knew that government regulators would be involved since day one. I am bullish on Elizabeth. She is obviously extremely intelligent and charismatic but I'm bearish on her investors. Step one of funding should have been building a blood test that actually works and step two is getting that $88M test approved. Without knowing the whole story it's hard to form an opinion about the situation but I am super interested in the psychology of how all "this" happened. Thoughts?
- CPLX 11y ago> It seems insane to me that a well respected venture firm like DFJ, who invested in their Series A,B and C, would not have done their due diligence She's childhood best friends with Tim Draper's daughter.[0] It really is that simple. If you saw a state construction contract going to a firm controlled by a friend of the Chinese Premiere's daughter you wouldn't be confused at all right? So why should anyone be confused now? [0] http://www.mercurynews.com/michelle-quinn/ci_26147649/quinn-meet-elizabeth-holmes-silicon-valleys-latest-phenom http://www.mercurynews.com/michelle-quinn/ci_26147649/quinn-...
- codinghorror 11y agohttp://www.forbes.com/sites/ryanmac/2016/01/22/clinkle-up-in-smoke-as-investors-want-their-money-back/ http://www.forbes.com/sites/ryanmac/2016/01/22/clinkle-up-in... > Clinkle had a polished demo that came before things like Apple Pay, said one former employee, who declined to be named. But most importantly that person added, Duplan “was charismatic when he wanted to be” and could “raise money in absurd abundance.” You really want to change the world? Forget being a programmer, learn to be be charismatic.
- bluker 11y agohaha exactly in case anyone is interested in doing just that, http://www.amazon.com/The-Charisma-Myth-Personal-Magnetism/dp/1591845947 http://www.amazon.com/The-Charisma-Myth-Personal-Magnetism/d...
- tacon 11y agoThe author gave a great talk in the Stanford Entrepreneurial Thought Leaders lecture series. She opens her talk with a delightful story about Marilyn Monroe, and the ability to flip charisma on and off like a light switch. Watch it and learn you some charisma. http://ecorner.stanford.edu/videos/3005/Build-Your-Personal-Charisma-Entire-Talk http://ecorner.stanford.edu/videos/3005/Build-Your-Personal-...
- nostrademons 11y agoI wouldn't say that either Theranos or Clinkle have changed the world. I would say that Apple, Google, EBay, Uber, Android, and Twitter have, but Steve Wozniak, Larry Page, Pierre Omidyar, Garrett Camp, Andy Rubin, and Evan Williams are far from charismatic. This is more an example of "You can fool some of the people all the time or all of the people some of the time, but you can't fool all the people all the time." Charisma can help fool a critical mass of people early on, but once you try to expand to a product all the people use all the time, you'll fall flat on your face. Build something useful and then you don't have to fool anyone.
- smacktoward 11y ago> Steve Wozniak Stepped on by the quite charismatic Steve Jobs > Evan Williams Stepped on by the quite charismatic Jack Dorsey
- mbesto 11y agoI don't think you picked up on Jeff's snark. I read it as "the key to successfully getting funding is to be charismatic" and "successfully getting funding" is currently synonymous with the sentiment that you would be "changing the world".
- dbcooper 11y agoSeveral sources have claimed that they have raised $750M in funding. http://fortune.com/2015/10/28/theranos-is-seeking-to-raise-200-million-in-new-funding/ http://fortune.com/2015/10/28/theranos-is-seeking-to-raise-2... IIRC, the $88.4M figure comes from their publicly disclosed funding as at end 2010.
- such_a_casual 11y agoI disagree with your opinion on the CEO. Intelligent? clearly, but also weird to the point that it's uncomfortable to watch her speak, and she's clearly very bad at handling the press.
- bluker 11y agoWhat is your definition of "intelligence" in this scenario?
- deleted 11y ago[deleted]
- dfsegoat 11y agoIt seems to be endemic to these biotech darlings: 23 & Me pulled the same thing and faced the same consequence. They thought as a tech prima donna that they did not have to adhere to the FDAs medical device regulations (or even publish efficacy data). They got smacked in the mouth - serves them right.
- CamperBob2 11y ago23 & Me's tests worked, though. And it's possible for a reasonable person to believe that the regulations they violated are BS. Their actions were arguably no more inherently immoral than Uber's "disruption" of the taxi incumbents and their captive regulators. This isn't the same thing at all.
- dfsegoat 11y agoThe ignorance of, and/or disregard for regulatory standards is the common thread here. Also, How do you know they work? They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise. That is not bullshit - that is effective regulation. The saddest thing is - even if you are right, all the FDA asked 23&Me to do was file a premarketing authorization -- something that many tiny companies do all the time to buy time to generate solid evidence.
- mattmcknight 11y ago"They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise." So if they delivered the results by mail or phone call they would have been in the clear? That is bullshit.
- dfsegoat 11y agoNope. It doesn't matter if the results came by courier pigeon: The test has not been validated in controlled trials or even published in peer-reviewed literature -- let alone approved by the FDA. If it were so simple don't you think they would have obtained approval by now? The sad thing is any idiot can invent a glucose meter and file their PMA properly -- but a company essentially backed by Google blows it horribly.
- whbk 11y agoWow, not mincing words. I think we've found our first dead unicorn of 2016.
- bahador 11y agoHow many employees do they have? I would imagine that the impact of a dead unicorn would be directly proportional to the number of employees it had.
- knd775 11y agoA quick google search suggests around 500.
- whbk 11y ago142 on LinkedIn - guessing whatever number you found is inflated by people working in clinics that do Theranos tests or something along those lines?
- jsprogrammer 11y agoMaybe LinkedIn doesn't capture every worker? You think they have greater than 30% penetration into the market?
- whbk 11y agoI've actually had the (dis)pleasure of doing a fair bit of work in this area and have found LinkedIn to be pretty directionally accurate - for tech companies, I'd ballpark it at closer to 80-90% in most cases. They may very well be one of the outliers - I typically saw that in businesses structured in a way that made it readily understandable (ie 75 core employees, but hundreds of hourly warehouse employees without LinkedIn accounts). Not sure if Theranos has such a structure - perhaps the medical/research side is much less likely to have LinkedIn accounts than the tech side.
- bedhead 11y agoI wonder how far Liz Holmes is going to take this thing. I wonder when it hits the breaking point where even she accepts the cold hard truth that this company that was famously valued at $9b is pure vaporware, built on little more than smoke and mirrors. Does the company need to file bankruptcy? Do investors need to sue to recover what money is left? Do insiders need to be criminally charged? I wonder...
- flormmm 11y agoSerious question: Even if Theranos goes down in flames, won't she walk away from this with a fortune? Maybe not quite the fortune she thought, but still many millions?
- tyre 11y agoQuite likely. In later rounds, founders are often strongly encouraged to take money off the table by selling equity. This isn't shady, it's so the founding team stops worrying about money and focuses full-time on the company. Ramen-profitable is good in the short term, but time becomes increasingly valuable as a company grows.
- kolbe 11y agoThis is true for many companies, but in the case of gross negligence[1], simply the action of her cashing out could be securities fraud and/or grounds for clawing back the money she took out. [1] which I'm not accusing Holmes of, but it's not out of the question, either.
- kzhahou 11y agoIt's common and its bullshit. If founders take from funding then so should employees. They should be able to stop worrying about money as much as the founders.
- bsder 11y ago> This isn't shady, it's so the founding team stops worrying about money and focuses full-time on the company. Uh, no. It's so that the founders won't sell the company at a mere 4-5x rather than then 20-100x that the VC's want. If it was genuinely about the company, they'd let all the initial people take some stock off the table. Instead they only allow the people who could sell the company to take stock off the table. Big difference.
- danielvf 11y agoWithout the actual statement of definicinies, there's not much to this letter other than that they have ten days to be in compliance with... something? Does anyone know what they are being ask to fix?
- minimaxir 11y agoPer WSJ, that is supposed to be released soon.
- aerovistae 11y agoWhere did you see that?
- minimaxir 11y agohttp://www.wsj.com/articles/problems-found-at-theranos-lab-1453684743 http://www.wsj.com/articles/problems-found-at-theranos-lab-1... (Paywall)
- refurb 11y agoYou can look up the regulations listed in the letter although you won't know exactly what their deficiencies are. What is interesting to me is that this is CMS, not the FDA. CMS runs Medicare and Medicaid and is basically saying that if they don't improve their compliance, CMS will stop paying for their lab tests.
- jforman 11y agoCMS administers the CLIA program. This is about their ability to operate as a lab, not just about Medicare reimbursement. See here for a clear breakdown of responsibility among government agencies: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
- dev1n 11y agoHaving a Unicorn go bust is akin to having a house get foreclosed on in your neighborhood in 2008. It doesn't reflect kindly on the value of the other homes in the neighborhood.
- minimaxir 11y agoThat is one of the reasons why venture capitalists not even affiliated to Theranos had suspiciously optimistic responses to the initial allegations last year: https://twitter.com/joshelman/status/655033793414238208 https://twitter.com/joshelman/status/655033793414238208 https://twitter.com/williamalden/status/658705178523258880 https://twitter.com/williamalden/status/658705178523258880 http://techcrunch.com/2015/11/21/in-defense-of-theranos/ http://techcrunch.com/2015/11/21/in-defense-of-theranos/ (Thanks to Analemma_ above for reminding me of this) The Theranos saga is incidentally one of the reasons I wrote the "You Can't Criticize Startups" rant on Monday. (to be fair, ignoring federal regulations is a different scope than mere criticism.)
- kzhahou 11y agoActually, minimaxir, when the stories first broke a few months ago, it was the rare case where VCs and SV insiders did criticize publicly. Google Ventures (bill Maris), e.g. I can dig up the other examples too.
- dev1n 11y agoI saw your post on the front page the other day but didn't have time to read it. I'll check it out. I'm a fan of your other posts. Keep up the solid writing!
- kriro 11y agoA related potential signal in the other direction: Draper made it surprisingly clear that they only provided seed money and no further investment. I believe the Theranos founder was friends with Draper's daughter and that makes it an even stronger signal imo (as you usually tend to stick up more for people you're friends with).
- danieltillett 11y ago
- Analemma_ 11y agoDo you remember when the WSJ first started really dismantling the Theranos house of cards last fall, how a bunch of prominent VCs and publications like TechCrunch, with a lot to lose if the startup bubble pops, immediately circled the wagons? There was a lot of "this is a media hit piece", "we need time to evaluate the technology", "Liz Holmes is a visionary", etc. I wonder if we'll be getting retractions and apologies from those people.
- kwisatzh 11y agoI don't think so. People behind Theranos from the VCs to the media are too powerful. Nothing much would change, I reckon.
- w1ntermute 11y agoRupert Murdoch is also very powerful, and he's no doubt personally OK'd this WSJ-led takedown of Theranos, even though Kissinger and pals can't be too happy.
- randycupertino 11y agoI've been very impressed with the WSJ coverage of Theranos. The same reporters broke the CMS Medicaid Fraud in 2014 and won a Pulitzer Prize. http://www.wsjplus.com/invites/medicare http://www.wsjplus.com/invites/medicare
- mnglkhn2 11y agoI think WSJ got to play the role where they finally pull the trigger on this company, to help it move along to its demise. Sometimes you hope the management and the board get the message and unwind things when the reality shows you that that particular game is done. And if they don't, then somebody has to come along and provide the kick. Theranos is done, for all intents and purposes: no proven new technology and nothing interesting at all on the business execution side. Just pure founder ambition and aggressive PR/marketing. Not enough to string things along too much.
- bgribble 11y agoThe corollary of "it's better to ask forgiveness than permission" is "sometimes, you will ask forgiveness and be told 'hell no, what were you thinking?'"
- fossuser 11y agoI don't understand the schadenfreude and hostility toward Theranos (and the founder). From everything I've seen there's very little actual information publicly available either way about what's going on (aside from some weak pop tech journalism). I'd imagine this negative media attention is stressful for them - like it is for any startup. Should minimally wait for something substantial to see if there was any actual wrongdoing - there's not much here so far.
- largehotcoffee 11y agoShould minimally wait for something substantial, see if there was any actual wrongdoing Pretty sure that's exactly what this is.
- fossuser 11y agoHardly - there's nothing in this other than not being in compliance with an unknown thing. Could be serious, but might just be some paper work.
- URSpider94 11y agoRead the letter. The conditions at the lab pose "immediate jeopardy" to health and safety. They go on to define immediate jeopardy as conditions that have caused, or are likely to soon cause, injury or death. It's not just a paperwork issue.
- fossuser 11y agoGovernment paperwork is often like this - it's hard to know what the actual condition is and what it's actually about.
- gherkin0 11y ago> not being in compliance with an unknown thing. This is that "unknown" thing https://en.wikipedia.org/wiki/Clinical_Laboratory_Improvement_Amendments https://en.wikipedia.org/wiki/Clinical_Laboratory_Improvemen... > Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States
- tyre 11y agoAt this point, we (HN community) are just treating this like a season of Jersey Shore. She's working her ass off to build a company with a mission far more important than email marketing or advertising or Candy Crush or blockchains. Were they overly optimistic in their projections? Probably, but try starting a company and not being optimistic. You'll never get off the ground. Did they not take reasonable precautions in an industry (biotech/healthcare) with serious repercussions? Absolutely. There are very real questions about her empathy and ethics. That said, let's stop getting giddy every time Theranos (or some other startup) shows weakness. As founders — those "playing startup" excluded — it is incredibly hard. Let's have some empathy ourselves for those who have (likely) fucked up.
- DenisM 11y agoThe problem with your logic is that it can be used to justify both legitimate innovation and any kind of snake-oil peddling. This just won't do as an argument.
- vkou 11y ago> She's working her ass off to build a company with a mission far more important than email marketing or advertising or Candy Crush or blockchains. And from all accounts, she's too busy playing PR games, as opposed to treating this like a mission far more important than email marketing. Theranos is in the business of medical testing. This is not an industry where you can half-ass your way through certification... Or where scrutiny like "Does the product you've been selling even work?" is misplaced. Theranos could dismiss this entire charade, if they could only provide evidence that what they claim to have built actually works.
- tyre 11y agoHonestly, I don't think they have the data. I'm not saying their product works or that she did the right thing. I do, however, question what the after-the-fact self-righteousness does for anyone. Should no one be working on this problem? How do we invest in potentially innovative ideas in more complex fields before they have proven it out?
- firasd 11y agoAny science or medicine types know if a potential solution to the problem this company wants to fix can be achieved by a 'hack' of sorts: just make a finger-prick, but keep it bleeding somehow (using mechanics or other chemical agents) until you can collect enough of a blood sample? Seems like an easier approach than inventing breakthroughs in microfluidics.
- randycupertino 11y agoThe problem is that the finger prick actually hurts a lot more than a traditional venous draw. There aren't any real benefits to a "finger prick" other than marketing spin that it's so easy breezy and good for people who can't stand needles. imo if Theranos had stayed out of microfluidics and stuck with fundamentals of testing but done it well- regular draws but used the best trained phlebotomists who can find the vein on the first stick, do a painless draw and really improved their model of "easy access" walk in Walgreens testing, immediate/fast under 24 hour results, pay up front and low cost, they could have overtaken Quest and Labcorp just by exploiting inefficiencies in that market. Instead they got too sidetracked focusing on razzle dazzle nanotainer microfluidic science that doesn't even work.
- joezydeco 11y ago"...There aren't any real benefits to a "finger prick" other than marketing spin..." "...regular draws but used the best trained phlebotomists who can find the vein on the first stick..." That's the advantage of a finger prick. You don't need to be a trained phlebotomist to do it. The microfluidics drove the idea that you only needed "a few drops" to perform the tests (since drawing 100mL out of a finger would take forever). Put those two together and you had the concept of a test that any semi-skilled person could perform in a drugstore. That was the hook Theranos was banking on.
- randycupertino 11y ago> You don't need to be a trained phlebotomist to do it. Yes, but Theranos still had phlebotomists doing their finger pricks. Also, phlebotomists aren't that expensive. Even in the Bay Area I think they only make around $18 an hour. Cheaper than a nurse, for sure.
- pboutros 11y agoThis is a little sensationalist - it's a list of deficiencies in their labs, not in their tests. More akin to an OSHA violation letter than a cease and desist letter. Here is an example of the regs that they are violating. It's things like lack of lab personnel certification. https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1441.pdf https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-... This is definitely not a good thing for Theranos, but it isn't them being called out for bogus biotech. (Not that that would surprise me immensely if it happened.)
- URSpider94 11y agoNo, it's worse -- this is basic blocking and tackling stuff that is table stakes for entering the medical testing space. This is not stuff that you "disrupt." As the letter says, these deficiencies could be putting customers' lives at risk.
- Aleman360 11y agoThat's exactly what the FDA does for medical devices. They don't test devices, they audit your facilities, processes, and product documentation.
- timr 11y agoIt's only "sensationalist" if you cherry-pick the most bureaucratic-sounding requirement, and ignore the first one in the list, which is a lot more fundamental to what a diagnostic lab does -- they're violating some unspecified part(s) of the quality system requirements for labs: https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1215.pdf https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-... These are horribly oppressive, bureaucratic, unnecessary requirements like "maintain basic scientific controls": https://www.law.cornell.edu/cfr/text/42/493.1256 https://www.law.cornell.edu/cfr/text/42/493.1256 This also is a section, it's worth nothing, that consists mainly of references to lots of other, more specific, requirements. There's really no way of knowing what the violations are, other than to take the letter at its word that the violations are serious. This isn't taxi medallions -- mess this basic stuff up, and you're putting people's lives directly at risk.
- jonathankoren 11y agoDefinitions of "conditional-level deficiency" and "immediate jeopardy" can be found at http://www.hospitalinspections.org/qa-with-cms/#10 http://www.hospitalinspections.org/qa-with-cms/#10 I can't say Theranos's comments about the matter even begin to assuage the concerns this brings. Trying to pass off the immediate jeopardy fault in hematology (i.e. blood testing) as "not apply[ing] to the whole lab" is absurd. It's like a restaurant saying that the board of health complaint that shut them down focused too much on the rat feces in the kitchen, and not enough on the well watered house plants in the dining room. It's so tone deaf.
- deleted 11y ago[deleted]
- randycupertino 11y ago> It's like a restaurant saying that the board of health complaint that shut them down focused too much on the rat feces in the kitchen, and not enough on the well watered house plants in the dining room To be fair, that has been Theranos' response to ALL criticism for the past 7 months. "Everyone is begging us for our secret recipes, but that is company secrets/proprietary science!"
- aczerepinski 11y agoCMS surveys, deficiencies, and plans of correction are to some extent business as usual for large health care providers. The article doesn't mention what they got hit with so it could be a big deal, or just an isolated incident that a surveyor happened to observe. Correcting the problem tends to be easy, but measuring and reporting back your progress creates administrative expense. An example is paying for someone to train your employees on something related to the deficiency and then doing a random audit of their records at regular intervals for a few months afterwards. Technically you can get shut down, but it isn't common.
- Naritai 11y agoIf your comment were to be somehow combined with jimrandomh's, they would instantly combine, leaving nothing in their place.
- aczerepinski 11y agoAgreed, but I've been through multiple CMS surveys, some with deficiencies, some without. Some POCs were scary, some laughable. Personnel issues can be trivial (somebody's cpr certification expired yesterday) or serious (you hired somebody who claims to be a doctor but isn't). It's really hard to weigh in as an outsider.
- emeraldd 11y agoIs anyone else seeing a bunch of missing letters in the linked pdf? I know it's a side issue but it really makes the letter hard to read.
- wahsd 11y agoWasn't she supposed to be God's own anointed founder CEO? All kidding aside, wasn't there some other controversy or someone revealed something about Theranos not too long ago? I guess I was right https://news.ycombinator.com/item?id=10984035 https://news.ycombinator.com/item?id=10984035
- hkmurakami 11y agoI'm guessing you're referring to the series of events consisting of (1) the original WSJ investigative report, (2) the Theranos rebuttal pointing out a missing piece of information in WSJ's report, and (3) WSJ coming back the very next day after the Theranos rebuttal with the very information they were called out on. It was all very beautiful to observe. ;)
- brandonb 11y agoIf you're a digital health entrepreneur and treating what's happening with Theranos as a wakeup call to do rigorous science, you could do worse than to work with the UCSF Center for Digital Health innovation: http://centerfordigitalhealthinnovation.org/ http://centerfordigitalhealthinnovation.org/ I'm a machine learning engineer working with UCSF cardiology. I certainly don't know all the answers, but I'm happy to try to answer questions or direct people to the right place.
- todayiamme 11y agoHey, how can I contact you?
- entee 11y agoI think it's quite dangerous when there's a company that says "we have breakthrough science, but we definitely can't tell you what it is", which was Theranos's M.O. for a long time. Working in medicine is hard, working with biology is hard, not just because of regulatory hurdles, but because fundamentally the problems in those fields are much more commonly questions of basic science than engineering. Good science leads to good companies, and if you can't do good science you're probably going to fail in this space. Good to see solid research institutions creating spaces to nurture good science at startups.
- brandonb 11y agoYep. I think there's room for scientists, engineers, and designers to contribute, but you have to publish peer-reviewed studies showing hard outcomes. Secrecy doesn't work in medicine.
- jimrandomh 11y agoI looked up what those laws referred to are, and... this is very very serious and Theranos is unlikely to survive it. The first two laws they are cited as having broken are about quality control standards. The next two laws they are cited as having broken are about qualifications that must be held by the laboratory director and technical supervisor. The last law they are cited as having broken is about qualifications that must be held by technicians. They have ten days to come into compliance, but in order to address these violations they will have to either hire new staff for key leadership and other positions, or pull their product from the market. They will do the latter. This same company was previously forced to pull their "nanotainer" testing system from the market because when regulators sent them control samples, they fraudulently tested them on different equipment and with different procedures than they used with patient samples. I will be surprised if no criminal charges are brought against Theranos CEO Elizabeth Holmes.
- aczerepinski 11y agoThey aren't laws, and they have ten days to submit a plan, not to execute the plan. Are you sure you know enough about this sector to weigh in on whether survival is likely?
- apsec112 11y agoFederal regulations (created by the executive) are technically different from statutes (created by legislators), but there can certainly be criminal penalties for violating them. I wouldn't be at all surprised if that were the case here, given the public safety implications of medical testing. The letter says that Theranos must provide "acceptable evidence of correction documenting that the immediate jeopardy has been removed". "Has been" is past tense, so Theranos really is required to fix the problems (at least the most serious ones) in ten days, not just plan to fix them.
- jimrandomh 11y agoNot laws? Those are section numbers from the US Code of Federal Regulations. Are you trying to point at the distinction between civil and criminal law?
- wahsd 11y agoPlease look past your possible distaste for the source, but Zerohedge has an interesting angle on the situation regarding the composition of the board. At least take a look at the bottom half of the analysis, but make sure not to read the comments. http://www.zerohedge.com/news/2016-01-27/beating-dead-unicorn-theranos-lab-poses-immediate-jeopardy-patient-safety-cms-warns http://www.zerohedge.com/news/2016-01-27/beating-dead-unicor...
- such_a_casual 11y agoThat article makes me think that it's possible that Theranos is more concerned with their government contract work than this "blood test for the common man" spiel.
- transfire 11y agohttp://seattleorganicrestaurants.com/vegan-whole-food/institutional-corruption-of-pharmaceuticals-how-FDA-cannot-be-trusted-with-public-safety.php http://seattleorganicrestaurants.com/vegan-whole-food/instit...
- hackaflocka 11y agoWhy is this being downvoted?
- tomp 11y agoBecause it has no context. But the title sounds interesting! "New Harvard study reveals Institutional Corruption of Pharmaceuticals and how FDA cannot be trusted with public safety"
- abrak 11y agoBecause the linked site seems flaky - no references. A google search for the title of the 'Harvard paper that is about to be published' only returns that site.
- hackaflocka 11y agoOK, makes sense.
- MollyR 11y agoUnbelievable. I really dislike this company for trying to pull a fast one with people's health. I really hope some lawyers file a suit against Elizabeth Holmes or something bad happens to create a strong disincentive from someone ever trying to do something like ever again. The chinese milk crisis is an extreme example of what could be done. The executives were executed or imprisoned, which again could be extreme, but I doubt anyone in china would ever try it again. http://news.bbc.co.uk/2/hi/asia-pacific/8375638.stm http://news.bbc.co.uk/2/hi/asia-pacific/8375638.stm
- jonsterling 11y agoTotally agree. We need to bring Industry to heel.
- hackaflocka 11y agoThis interview snippet (only 4 minutes long) with the CEO Elizabeth Holmes is a revealing look into the mind of a possibly crazy person (crazy with power). https://www.youtube.com/watch?v=MBs-oj7U-bo https://www.youtube.com/watch?v=MBs-oj7U-bo
- hackaflocka 11y ago100% agree. Except that USAians believe that they live in a meritocracy.
- stickfigure 11y agoWe USAians believe that Theranos will either work out a viable business or run out of money and close doors. It may not be a perfect meritocracy, but it's more so than most of rest of the economies of the world.
- theklub 11y agoOnly the naive ones think that.
- learc83 11y agoThe accepted English demonym is American, and it has been for the last 200 years. Did you think you would be misunderstood if you said American? The USA is the only country in the world with the word America in the name. Part of the world does consider North and South America to be one continent, but most of the English speaking world does not. Therefore in English there is no ambiguity when referring to someone as an American. You'll also note that no one has any issue with Australians calling themselves Australian, despite the fact that Australia is not the only country on the Australian continent.
- redwood 11y agoI agree with just about everything you said except that Australia is really just home to one country. or am I about to learn something new?
- redwood 11y agoI agree with just about everything you said except that Australia is really just home to one country. or am I about to learn something new? Oh I see the shelf includes other islands
- learc83 11y ago
- lsiebert 11y agoHmm... I have a very good friend who is looking for a better job doing quality, regulatory, or compliance work at a biotech/medical device company. From what I understand, this seems kinda like the stuff a company in this area deals with regularly; It's just that most companies just don't publicize it. Anyway forwarded this to him. edit: I should clarify, I mean general regulatory issues, I'm not commenting on the specifics, but every company faces audits and inspections.
- bane 11y agoDiscussion about a month ago https://news.ycombinator.com/item?id=10765562 https://news.ycombinator.com/item?id=10765562 For the record, I'm pretty sure Theranos is up to something very shady. Spend a couple hours watching just interviews with Holmes and reading the glassdoor reviews by current and former employees and you'll quickly start to piece together some pretty sketchy stuff. Their glassdoor profile is full of some of the most obviously fake reviews I've ever seen, I wouldn't at all be surprised if about half of them were written by Holmes herself instead of running the company. https://www.glassdoor.com/Reviews/Theranos-Reviews-E248889.htm?sort.sortType=RD&sort.ascending=false&filter.employmentStatus=REGULAR&filter.employmentStatus=PART_TIME&filter.employmentStatus=UNKNOWN https://www.glassdoor.com/Reviews/Theranos-Reviews-E248889.h... Here's what I wrote on this about a month ago. https://news.ycombinator.com/item?id=10765996 https://news.ycombinator.com/item?id=10765996 I've since spent some time looking into the company and asking some people I know in the industry about the company and the opinion seems to run from "scam" to "gross ineptitude". Holmes' answers to simple questions are about as mealy mouthed as I've ever heard outside of Congress. e.g. https://www.youtube.com/watch?v=MBs-oj7U-bo https://www.youtube.com/watch?v=MBs-oj7U-bo Something smells really bad about Theranos and it's probably going to ruin a lot of people's careers while a select few are going to walk away with a nice percentage of the VC money in the end. The story on this will probably get caught up in post-Theranos litigation for many many years and I'll probably be retired long before the whole story is known. The real problem is trying to ascertain motive. Money seems too easy for Holmes to have been working at it for so long. But it could be that simple.
- deleted 11y ago[deleted]
- such_a_casual 11y agoWhile it does sound like she's trying to sound like a man, I'm not sure if it's forced. Even if it's not her real voice, it's natural to have a different voice when speaking as a CEO in an interview (it may only be slightly off from her real voice). Her voice is consistent across interviews, so I don't think it's as fake as you might assume.
- 11y ago
- akhilcacharya 11y agoI do hope Aaron Sorkin writes a movie about this.
- hashmymustache 11y agoThey'd make the script a proprietary secret
- TerryADavis 11y agoCIA 1988 Looks some some smart-ass Jew-doctor trying to be psy-op. God says... Katy's jiffies highway earnestness appliquéing defiantly nicknacks molybdenum's dwellers toxicity huskiness hydrology godlier trashes ratification Leviticus egos romanced ocelot crunch's cornet sword reforested worker bristled tiddlywinks industrial priory's wiretap tremulous capture liqueur's
- enziobodoni1 11y agoTo start with, I am a clinical lab medical director and clinical pathologist. I've commented on Theranos a few times before on HN. That said, I think three things have been missed in all of this 1) There are a lot of bad labs out there like Theranos, and Theranos' story is thus only unique because of how pumped up it got. Clinical labs are "old economy" businesses, and the idea that someone could sprinkle "new economy" fairy dust and turn it into an Uber or Netflix success story is more about the echo chamber that is Silicon Valley, the general lack of scientific interest or rigor in clinical diagnostics in the tech industry, a somewhat Aspergey yet charismatic CEO, black turtlenecks, and friendship with important ex-government officials and VC folks than anything special about what was going on in their laboratory. Plenty of labs have been caught and shut down for what Theranos has done, and while I didn't think that it was actually occurring there, I am not terribly surprised. 2) The magic of their Edison box, even if it had turned out to work, was not nearly as impressive if you know anything about how clinical labs operate today. The claims that they have made (can do tests on MICROLITERS and have imprecision LESS THAN 5-10%!) are actually standard these days for many assays. As a lab director, I was always disturbed by the lay press puff pieces that said things about Theranos that were totally uninteresting and unimpressive to anyone knowledgeable...what clearly happened was that no one at Forbes, etc.. actually asked anyone who works in a clinical lab to comment. The commentary always focused more on the phenomenon of Theranos, rather than the substance...probably because the substance was super boring. 3) What has consistently been missed, and is still missed today, is that even if Theranos' technology worked and their labs weren't being run with a criminal disregard for standard laboratory practice, is that Theranos' business objectives would STILL be a horrible idea. Their push to democratize health information, to do more testing early to prevent disease rather than detect late, to test for lots of things in healthy people to increase "wellness", etc... is all total bullshit. With few exceptions, lab tests are for sick people, and testing healthy people with lots of tests simply consumes money and generates false positive results that are expensive to work up. Also, there are NO TESTS for all of the conditions (cancers, etc...) that they claim to be helping you detect early. Getting your sodium and potassium levels weekly won't help you avoid kidney disease, cancer, or diabetes, but it will make your pocketbook shrink and it will give you some falsely abnormal values 1 in 20 times you do it. This has been the true play of Theranos, which is to do a massive amount of testing on well people, marketed directly to healthly people without the advice of doctors, with the intent of arming a bunch of worried well people with an avalanche of insignificant noisy information to present to their physicians. This helps no one other than Theranos. I have often seen a lot of objections to (3) from people on HN, especially tech-sorts who think that they are better able to handle data than the average person. However, this is fundamentally flawed. For those who are interested in Bayesian analyses, consider the utility of any test when the pre-test probability is low - the answer is that positive results are almost always false positives, or at least difficult to interpret. The answer is not getting more tests, even if it's cheap. Lab tests these days ARE cheap...it's the clinical followup that is expensive. I will be very interested to see how this all plays out now. The big players, Labcorp and Quest, have both tried the direct-to-consumer/in-drugstore model for testing, and amusingly actually shut their offerings down years ago because of lack of interest. The truth of the matter is that making health information more available to people sounds great, but really, the only people who end up collecting that information are affluent, worried-well people who should be discouraged from testing in the first place. The people who need more routine testing are poor, socially-underserved and neglected people with chronic illnesses, but I do not think that Theranos is planning on opening test facilities in Flint, Michigan to give Hemoglobin A1c monitoring tests for free to the elderly impoverished people there. To the contrary, they've tried to open in areas where they can get customers who they can trap into believing that they need lab tests like they need step counts from a fitbit. Hopefully, this bump in the road will caution others trying to do the same thing, but I really doubt it.
- enziobodoni1 11y agoTo start with, I am a clinical lab medical director and clinical pathologist. I've commented on Theranos a few times before on HN. That said, I think three things have been missed in all of this 1) There are a lot of bad labs out there like Theranos, and Theranos' story is thus only unique because of how pumped up it got. Clinical labs are "old economy" businesses, and the idea that someone could sprinkle "new economy" fairy dust and turn it into an Uber or Netflix success story is more about the echo chamber that is Silicon Valley, the general lack of scientific interest or rigor in clinical diagnostics in the tech industry, a somewhat Aspergey yet charismatic CEO, black turtlenecks, and friendship with important ex-government officials and VC folks than anything special about what was going on in their laboratory. Plenty of labs have been caught and shut down for what Theranos has done, and while I didn't think that it was actually occurring there, I am not terribly surprised. 2) The magic of their Edison box, even if it had turned out to work, was not nearly as impressive if you know anything about how clinical labs operate today. The claims that they have made (can do tests on MICROLITERS and have imprecision LESS THAN 5-10%!) are actually standard these days for many assays. As a lab director, I was always disturbed by the lay press puff pieces that said things about Theranos that were totally uninteresting and unimpressive to anyone knowledgeable...what clearly happened was that no one at Forbes, etc.. actually asked anyone who works in a clinical lab to comment. The commentary always focused more on the phenomenon of Theranos, rather than the substance...probably because the substance was super boring. 3) What has consistently been missed, and is still missed today, is that even if Theranos' technology worked and their labs weren't being run with a criminal disregard for standard laboratory practice, is that Theranos' business objectives would STILL be a horrible idea. Their push to democratize health information, to do more testing early to prevent disease rather than detect late, to test for lots of things in healthy people to increase "wellness", etc... is all total bullshit. With few exceptions, lab tests are for sick people, and testing healthy people with lots of tests simply consumes money and generates false positive results that are expensive to work up. Also, there are NO TESTS for all of the conditions (cancers, etc...) that they claim to be helping you detect early. Getting your sodium and potassium levels weekly won't help you avoid kidney disease, cancer, or diabetes, but it will make your pocketbook shrink and it will give you some falsely abnormal values 1 in 20 times you do it. This has been the true play of Theranos, which is to do a massive amount of testing on well people, marketed directly to healthly people without the advice of doctors, with the intent of arming a bunch of worried well people with an avalanche of insignificant noisy information to present to their physicians. This helps no one other than Theranos. I have often seen a lot of objections to (3) from people on HN, especially tech-sorts who think that they are better able to handle data than the average person. However, this is fundamentally flawed. For those who are interested in Bayesian analyses, consider the utility of any test when the pre-test probability is low - the answer is that positive results are almost always false positives, or at least difficult to interpret. The answer is not getting more tests, even if it's cheap. Lab tests these days ARE cheap...it's the clinical followup that is expensive. I will be very interested to see how this all plays out now. The big players, Labcorp and Quest, have both tried the direct-to-consumer/in-drugstore model for testing, and amusingly actually shut their offerings down years ago because of lack of interest. The truth of the matter is that making health information more available to people sounds great, but really, the only people who end up collecting that information are affluent, worried-well people who should be discouraged from testing in the first place. The people who need more routine testing are poor, socially-underserved and neglected people with chronic illnesses, but I do not think that Theranos is planning on opening test facilities in Flint, Michigan to give Hemoglobin A1c monitoring tests for free to the elderly impoverished people there. To the contrary, they've tried to open in areas where they can get customers who they can trap into believing that they need lab tests like they need step counts from a fitbit. Hopefully, this bump in the road will caution others trying to do the same thing, but I really doubt it.
- LevyJenningsSD2 11y agoAs a medical laboratory professional I can shed some light: The Immediate Hazard Hematology citation comes from an expired reagent being used on a Hematology analyzer (clearly a standard Siemens analyzer, not the mysterious new technology they won't disclose). This is easily fixable, but reveals a great deal about what is ACTUALLY going on in that lab The Laboratory Director and Technical Consultant citations are standard when you have an Immediate Hazard citation. But they also reveal how poorly organized this lab is and how whomever is responsible for the laboratory leadership at a directorship level knows NOTHING about CMS laboratory regulations, or tried to pull a fast one on CMS/CLIA by hiring a patently unqualified Dermatologist to be a part-time director of a CLIA high-complexity lab. This is a MASSIVE glaring error in leadership and quality assurance at the very highest level. The executive leadership of this company appears to know nothing about the business they seek to upend. I am sure the Cleveland Clinic is wondering WTH they got themselves involved with. Also very telling that Holmes was at Cleveland Clinic the day after this letter was released. They are clearly operating as a bog-standard lab doing conventional testing to be able to report patient results and be a traditional CLIA-certified lab (except may be one test they have - the HSV) This significant fact seems to have escaped everyone. They can't report any tests performed by their top-secret technology because it ain't FDA approved. For a conventional refererence lab like Quest or Labcore, their inspection faults would be embarrasing but fixable. For Theranos, it's likely fixable but the PR fiasco may be ultimately fatal. Someone shoukd really have studied the industry they seek to upturn and worked with real professionals rather than pusing global dominance and glossy PR. The cart is miles ahead of the horse at Theranos