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Theranos CEO Elizabeth Holmes Banned From Owning a Lab (engadget.com)

An anonymous reader quotes a report from Engadget: The Wall Street Journal reports U.S. regulators have devised to ban the owners and operators of Theranos from running a lab for two years. That includes CEO and founder Elizabeth Holmes, as confirmed by a press release issued tonight. The Centers for Medicare and Medicaid Services (CMS) revoked the lab's Clinical Laboratory Improvement Amendments (CLIA) certificate and imposed a civil money penalty for an unspecified amount. The ban does not take effect for 60 days, however Theranos says it will not do any testing at the Newark, CA lab CMS investigated, and instead will serve customers from its lab in Arizona. Elizabeth Holmes wrote: "We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions. Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures. While we are disappointed by CMS' decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance."

29 of 146 comments (clear)

  1. Hah! I can own as many labs as I want! by Anonymous Coward · · Score: 5, Funny

    Take THAT, Elizabeth Holmes

    1. Re:Hah! I can own as many labs as I want! by tripleevenfall · · Score: 5, Funny

      And your results would be just as accurate as hers.

  2. Normally I'm pro regulation by EzInKy · · Score: 2, Insightful

    But this is a problem I believe the markets and courts actually could handle.

    --
    Time is what keeps everything from happening all at once.
    1. Re:Normally I'm pro regulation by vadim_t · · Score: 4, Insightful

      The vast majority of people, even the really smart ones working for the justice system aren't expert biologists able to evaluate the quality of a lab's work. Neither would they be granted enough access to actually run a proper evaluation, even if they did have the knowledge.

      And what's the benefit to allowing a lab that produces incorrect results to keep operating?

      We need both. Regulation ensures that every lab performs correctly, and the free market ensures the labs compete against each other on the price and services they offer. With both those things in place and working properly we can ensure you can't go wrong by choosing a lab, and just have to concentrate on finding one that does what you need at an acceptable price and speed.

    2. Re:Normally I'm pro regulation by advocate_one · · Score: 4, Insightful

      Regulation ensures that every lab performs correctly

      Not just regulation, but an inspection and certification regime as well. Random, unannounced inspections work best of all...

      --
      Donald 'Duck' Dunn: We had a band powerful enough to turn goat piss into gasoline.
    3. Re:Normally I'm pro regulation by Anonymous Coward · · Score: 5, Insightful

      How? For those who don't know, Theranos is mainly in the business of performing blood tests on behalf of the government, hospitals, pharmacy companies, employers and suchlike. The people who actually stand to lose from faulty test results are by and large the people whose blood is being tested, but these are not the people who pay for the tests directly, nor are they the people who choose which lab should perform the analysis. Since there is no financial connection between the actors and the desired outcome, the free market can in this case never work and hence regulation is required.

    4. Re:Normally I'm pro regulation by K.+S.+Kyosuke · · Score: 5, Insightful

      So we don't need to ever protect consumers from dangerous food either - if it kills you, you simply won't buy it the next time!

      --
      Ezekiel 23:20
    5. Re:Normally I'm pro regulation by dcw3 · · Score: 2

      So we don't need to ever protect consumers from dangerous food either - if it kills you, you simply won't buy it the next time!

      Whatever kills you makes you stronger...oh, wait.

      --
      Just another day in Paradise
    6. Re:Normally I'm pro regulation by tripleevenfall · · Score: 2

      It already has worked. For example, Walgreens recently dumped the pilot they were doing with Theranos.

      A company that had considered working with them has to maintain its legitimacy. Your company's reputation is a market force.

    7. Re:Normally I'm pro regulation by tnk1 · · Score: 2, Insightful

      You have a point, although it should be pointed out that natural selection, which is ultimately what the so-called "free market" really is, can create some very complex self-regulation which is very adaptive.

      The problem, as many would be happy to tell you, is that such selection does often happen at the expense of individuals. So we get regulation to try and prevent those outcomes.

      Of course, we know that even regulation doesn't save everyone, and it can have its own problems which are inherent to interventionist regulation.

      So the question is probably phrased better as being whether, over the long term, we're better off with government regulation or the market being allowed to sort it out. It may well be possible that the market would have a better long term solution, but there is almost certainly going to be a cost to that. And yes, that cost could come at the expense of its very own proponents.

      In and of itself, that doesn't actually discredit anything. There are those who believe that outlawing guns is the best thing to do to prevent most mass murders, and that would seem to be almost a no-brainer. However, that very same person might find themselves in a position where they were hurt or even killed in a situation they would not have if they had ready access to a gun. Most gun-control advocates would probably argue that just because that person in that one situation died for lack of a gun doesn't mean that the lack of guns is a bad idea overall.

      There are two types of people who suggest a course of action that they know may come back and bite them in the ass personally: the stupid and the courageous. We assume that it is stupid to let the dog eat dog process of market forces create regulation for us, and perhaps it really is stupid and we can do a better job by intervention.

      That said, I don't think those forces have ever really been allowed to operate to their full extent, for a sufficient amount of time, outside of fictional accounts. We have measured some of the costs of unregulated situations, but I'd argue that they have to play out over longer periods of time than we've ever actually allowed, for them to produce any tangible benefits.

    8. Re:Normally I'm pro regulation by HornWumpus · · Score: 3, Insightful

      You realize that 'chocolate' is not an actual addiction? It's just a figure of speech.

      I can quit anytime I want...

      --
      John McAfee 'It was like that time I hired that Bangkok prostitute; to do my taxes, while I fucked my accountant'
    9. Re:Normally I'm pro regulation by JustAnotherOldGuy · · Score: 4, Insightful

      So we don't need to ever protect consumers from dangerous food either - if it kills you, you simply won't buy it the next time!

      Exactly. The magical "invisible hand" of the "free market" at work!

      This is the blind spot most libertarians have: they never stop to think that they might be the ones getting fucked, it'll always be the other guy. It'll never be YOUR wife or YOUR child who dies from some untested medication or contaminated food or unsafe electrical appliance.

      It'll always be some other guy whose wife or kid dies, and then the Magical Invisible Hand Of The Free Market will punish that company and force them out of business, so they'll be safe, right?

      But it won't be your wife or your kid, no way. And if it IS your kid or your wife, well shucks, you can just take them to court for damages, right? Because that's the magical Libertarian answer to any problem that occurs: don't try to prevent a problem from occurring through regulation or legislation, just sue someone after something bad happens!

      --
      Just cruising through this digital world at 33 1/3 rpm...
    10. Re:Normally I'm pro regulation by whoever57 · · Score: 2, Informative

      It already has worked. For example, Walgreens recently dumped the pilot they were doing with Theranos.

      The free market wasn't responsible for that. Walgreens only dumped Theranos because of the government laws and regulations. It was a regulatory investigation of Theranos that discovered the issues.

      --
      The real "Libtards" are the Libertarians!
    11. Re:Normally I'm pro regulation by Spazztastic · · Score: 3, Informative

      > Random, unannounced inspections work best of all...

      The FDA does this regularly, especially if you have had any audit findings. Major and Critical findings almost always result in a random follow up audit.

      --
      Posts not to be taken literally. Almost everything is sarcasm.
    12. Re:Normally I'm pro regulation by crawling_chaos · · Score: 2

      I am going to suggest that you start buying your mushrooms at the store instead of hunting them up yourself.

      --
      You can only drink 30 or 40 glasses of beer a day, no matter how rich you are.
      -- Colonel Adolphus Busch
    13. Re:Normally I'm pro regulation by dog77 · · Score: 2

      Most libertarians believe in liability and rule of law. So in a libertarian utopia, it is not just the free market that punishes a wrong doer.

  3. Aww, that's harsh by wonkey_monkey · · Score: 5, Funny

    Theranos CEO Elizabeth Holmes Banned From Owning a Lab

    But labs are so sweet!

    Maybe she could get a beagle instead.

    --
    systemd is Roko's Basilisk.
    1. Re:Aww, that's harsh by dcw3 · · Score: 2

      Theranos CEO Elizabeth Holmes Banned From Owning a Lab

      But labs are so sweet!

      Maybe she could get a beagle instead.

      Note that the ruling does not ban her beagle from owning a lab . . .

      Seems much like G. Gordon Liddy...When asked how he was able to maintain such a close relationship with guns despite his status as a convicted felon, Liddy replied, "Mrs. Liddy has an extensive collection of firearms, some of which she keeps on my side of the bed."

      --
      Just another day in Paradise
  4. So much for remorse by ortholattice · · Score: 5, Insightful

    " While we are disappointed by CMS' decision,..."

    If she had any sense of ethics, she would be grateful the CMS is doing its job of protecting the public from dishonest people like her. Why isn't she in jail for falsifying test results and endangering people's lives?

    She's not sorry she did it, only that she got caught. Typically psychopathic behavior, Sadly she'll probably be successful someday, lying, cheating, and using people on her way up.

    1. Re:So much for remorse by Anonymous Coward · · Score: 5, Insightful

      " Why isn't she in jail for falsifying test results and
      endangering people's lives?

      Perhaps because she's a scion of Millennial Feminism and female STEM empowerment.

    2. Re:So much for remorse by nitehawk214 · · Score: 2

      Either that or because her parents are super rich and she is very well connected politically.

      Hell, maybe some of the politicians were in on the scam and she has them by the metaphorical balls preventing her from being prosecuted?

      --
      I'm a good cook. I'm a fantastic eater. - Steven Brust
  5. She should admit she's a fraud by smooth+wombat · · Score: 4, Interesting

    As the hits keep coming, it might benefit Ms. Holmes to openly admit she's been a fraud from day one. She's ripped off investors with false claims and has endangered people's lives with her false results.

    To date, Theranos has never allowed a peer review of her process, has never submitted to government tests and has admitted they don't use their own testing procedures, instead going back to the tried and true method.

    Give it up, Holmes. Your days are numbered.

    --
    We will bankrupt ourselves in the vain search for absolute security. -- Dwight D. Eisenhower
    1. Re:She should admit she's a fraud by Anonymous Coward · · Score: 2, Interesting

      As the hits keep coming, it might benefit Ms. Holmes to openly admit she's been a fraud from day one. She's ripped off investors with false claims and has endangered people's lives with her false results.

      To date, Theranos has never allowed a peer review of her process, has never submitted to government tests and has admitted they don't use their own testing procedures, instead going back to the tried and true method.

      Give it up, Holmes. Your days are numbered.

      I've followed Theranos rather closely for years. I'm not sure she can admit fraud, because admitting it first means you have to believe it and I don't think she does. The sheer arrogance of the woman is astonishing, to think that she as a college dropout knew more about biochemical testing than thousands of clinical pathologists, and all she had to do was dilute samples to run them on her machine, or it turns out standard machines from Siemens as her machine wasn't even used. Then the non-stop gushing media stories about her being the next Steve Jobs; what a joke. It's no wonder her Board had nothing but politicians on it; the entire company was nothing but propaganda supporting an arrogant narcissist.

    2. Re:She should admit she's a fraud by smooth+wombat · · Score: 2

      because admitting it first means you have to believe it and I don't think she does.

      Delusional psychopaths* generally have this problem.

      * I'm probably not using the correct term but you get my meaning

      --
      We will bankrupt ourselves in the vain search for absolute security. -- Dwight D. Eisenhower
  6. Re:Ask yourself this question by JaredOfEuropa · · Score: 2

    ... and now she's running for President.

    Considering that the alternative is Trump, you guys may want to let this one slide...

    Seriously, out of what (for an outsider at least) have been the most interesting presidential nominations in ages, these two clowns emerged as the GOP and Dems candidates? What the hell...

    --
    If construction was anything like programming, an incorrectly fitted lock would bring down the entire building...
  7. Re:Ask yourself this question by dywolf · · Score: 3, Informative

    Benghazi has been "resolved" 7 or 8 times, and the best they can come up with is "you're foresight should have been 20/20 just like our hindsight. and BTW, please ignore the disparity with the Bush administration's 90 odd dead at embassies".

    she was branded a congenital liar, but that doesn't actually make it so.
    they've simply repeated it for so long people accept it as truth.
    the simple fact is she's probably the most honest politician to ever run for president, with the overwhelming majority of her statements being factual.
    compared to someone like Trump who mostly speaks falsehoods...yet somehow she's the "liar". that's not to say she isn't also very aloof; but then I'd somewhat expect that of someone who has withstood baseless attacks for 40+ years. after dealing with the same BS for that long you'd probably stop caring what they say and think about you too.

    this guy states it rather more eloquently:
    http://www.dailykos.com/story/...

    In January of 1996, while Whitewater investigations were underway but unfinished, conservative writer William Safire wrote a scathing and now-famous essay about Hillary Clinton entitled, “Blizzard of Lies”. In the piece he called her a “congenital liar”, and accused her of forcing her friends and subordinates into a “web of deceit”. He insisted ( without any apparent evidence ) that she took bribes, evaded taxes, forced her own attorneys to perjure themselves, “bamboozled” bank regulators, and was actively involved in criminal enterprises that defrauded the government of millions of dollars. He ended the piece by stating that, “She had good reasons to lie; she is in the longtime habit of lying; and she has never been called to account for lying herself or in suborning lying in her aides and friends.”

    I am no political historian, but as far as I can tell this short essay was the birth of the “Hillary is a Liar” meme. Now to be clear, most conservatives already strongly disliked her. They had been upset with her for some time because she had refused to play the traditional First Lady role. And they were horrified by her attempt to champion Universal Health coverage. But if you look for the actual reasons people didn’t like her back at that time, you won’t see ongoing accusations of her being “crooked” or a “liar”. Instead, the most common opinion seemed to be that she was a self-righteous leftist who considered anyone with other views to be morally inferior. In short, the prevailing anti-Hillary accusation was not that she was unrelentingly dishonest, but that she was just intolerably smug.

    After the Safire piece however, this all changed. Republicans, who learned from Nixon never to let a good propaganda opportunity pass if they could help it, repeated the accusations of mendacity non-stop to anyone who would broadcast or print them. And if you doubt the staying power of Safire’s piece, type the phrase “congenital liar” into a Google search along with “Hillary Clinton” and see what happens. To this day, that exact phrase is still proudly used by many on the right. This, even though Safire was eventually proven wrong about everything he had written. And despite the fact that he stated himself that he would have to “eat crow” if she were ever cleared, Safire never apologized or even acknowledged his many errors once that happened. Because as we all know, swift-boating means never having to say you’re sorry.

    in short: the butthurt is strong today.

    --
    The guy who said the election was rigged won the presidency with the second-most votes.
  8. Re:Lol Business by Anonymous Coward · · Score: 5, Insightful

    Holmes is persona non-grata right now. She raised the money she did through family connections; her parents were both highly placed bureaucrats who knew top level folks which is why her Board was made up of politicians and why she still retained a majority stake despite all the funding. Her first real round of money came from Tim Draper of Draper Fischer Jurveston, who is a personal friend of her parents and the scuttlebutt says helped her next round of funding too, which included people like the Larry J Ellison Trust (around $20-$30M). Her big round of $400M was a mix of private equity money and Blue Cross Blue Shield Ventures, so insurance firms hoping her cheap tests would make testing more affordable; only BCBS Ventures has any real experience investing in biotech and even them it's from an insurance angle, not from an angle of real science.

    However, she will not work in biotech again. The interesting thing is that all of her investors were not typical biotech investors, and the real biotech VC funds such as Lateral Ventures, Flagship, Polaris, Domain, New Leaf, funds that have experience investing in real science that creates real medical products, they all turned her down thinking she was a fraud. Miss Holmes got lucky when she got Theranos going as there was a wave of money entering biotech from non-traditional sources, mostly tech entrepreneurs looking for new places to put their money and thinking biotech was the next hot thing. Many of these investors dumped money into ideas that sounded great because they were neat technology, but unlike in software in biotech having the best tech does not guarantee you success, you also need to pass both the regulatory and the insurance reimbursement hurdles and those hurdles require a level of design sophistication and validation most in tech aren't used to. The result was many of these typical tech investors and entrepreneurs dumped a ton of money into ideas that had no chance of success based purely on charisma of the leader and the gee-whiz factor of the technology without truly understanding what they were getting into. The easy money from 2011-2015 for biotech from non-traditional sources is gone completely now, leaving the traditional investors standing and those guys won't touch her; reputation in biotech matters way too much and they won't want her anywhere near their companies.

    No, Holmes is finished in Biotech. What I suspect is she will be on the Board of Theranos while a new CEO steps in, who will find the company a giant mess and essentially either wind it down or find some buyer to make the shareholders come out ok. Most of her shareholders likely hold preferred equity to Miss Holmes' common, meaning they get to divide up the money before she does and I doubt anything will be left over. Meanwhile she'll lay low for a few years and let the next big crisis make Theranos fade from memory, then she'll end up a partner and some venture fund investing in companies and make her essentially the next Ellen Pao.

  9. Re:Lol Business by AntronArgaiv · · Score: 4, Insightful

    What would she need to own a lab for? She never did any research to begin with?

    Holmes is 100% pure corporate CEO/Board-member. She has connections, extraordinary bullshitting abilities, and is tied in to god knows how many VC and Silicon valley based "ventures". She doesn't need a lab, or scientists, or engineers. She hires the people who hire them.

    Holmes will be back with a bio-med big-data startup within 3 years. Bookmark this post.

    She's an interesting example of how far you can get with money, influence and a positive approach, in the absence of any real understanding of the details of the business you're in.

    Maybe she can use the time off to finish college.

  10. "I" suddenly becomes "we" when things go wrong by JoeyRox · · Score: 2

    Interesting how it was all about her when Theranos was the best thing since slice bread but suddenly it's "we" in her statement yesterday even though she was the one specifically banned from the industry for 2 years.