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Biotech Businesses Medicine Science

Allegations of Data Manipulation At Theranos (wsj.com) 97

Posted by Soulskill from the if-it-looks-too-good-to-be-true-it-probably-is dept.
An anonymous reader writes: A lengthy report at the Wall Street Journal brings allegations of data manipulation against blood-testing startup Theranos. The company raised hundreds of millions of dollars from investors, at a valuation of roughly $9 billion, on the hope that they can revolutionize medical diagnosis. They've also made agreements with Safeway and Walgreen's to offer blood tests within stores. But multiple former employees say Theranos was shaky on the science at best, and intentionally misrepresentative at worst.

Engineer Anthony Nugent says the device intended for Walgreen's was still experimental. He also recalls seeing the machines labeled "for investigational use only," because of poor accuracy. A Theranos lab worker "told federal authorities that the results from the quality-control runs diverged from the known amount by more than two standard deviations, a red flag that suggested possible accuracy problems." When that employee notified superiors within the company, somebody came and deleted the quality control data, which made the device's test runs appear better than they were. There are also reports that inspectors and auditors were purposefully kept away from parts of Theranos's lab. A Theranos spokesperson denied everything.
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Allegations of Data Manipulation At Theranos More

Allegations of Data Manipulation At Theranos

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  • Looks like they finally found a replacement for Carly Fiorina. I see a bright future for Ms Holmes.
  • What kind of company gives itself a name that is so close to "Thanatos"? Creepy at best.

  • Medicine is too important to be a 'for profit' industry.

    • Re: (Score:1)

      by Anonymous Coward

      Medicine is too important to be a 'for profit' industry.

      Hate to break it to you, but SOMEBODY is making money off of a pretty large fraction of modern medicine.

      The problem with this company is that they claim to have some secret new technology/methodology that will revolutionize the industry. And they won't tell anybody how it works. While I understand trade secrets, secret stuff that nobody is allowed to reproduce or check is pretty scary when it comes to peoples' health.

      • FDA (Score:2)

        by Kludge ( 13653 )

        This is why you have scientific FDA oversight of medical products.
        Medicine for profit drives innovation. Unfortunately history has shown that hucksters abound with their secret formulas and technology. This is why the FDA exists. You can make all the money you want, but you have to prove to the FDA that it works both in principle and in practice.

        • Re: (Score:2)

          by lucm ( 889690 )

          Theranos is the first testing lab to go through a FDA validation process. They've done that voluntarily in order to pave the way for future stuff they want to do.

          That company is like the Walmart of blood testing, and not just on their proprietary platform. They do all kinds of tests on regular machines so they can build a customer base and deliver tests for less money, hoping that in the future they'll be able to do more tests without draining people of their blood and money.

          But instead of getting kudos, th

  • The tech was never important to me. (Score:5, Interesting)

    by w3woody ( 44457 ) on Monday December 28, 2015 @10:24AM (#51195093) Homepage

    It's a shame Theranos is having so many problems, because to me it was never about blood testing using small volumes of blood, but about low cost DIY blood testing available at places like Walgreens. The ability to walk in and get a Cholesterol test for $3, and a comprehensive metabolic plane for $7 instead of going through a doctor (and paying several hundred dollars for the privilege of having that doctor cluck-cluck at me) is a big deal: it means I could (for example) try different diets and get a blood test monthly to see how those diets affect me.

    • Even if the tech were as accurate as the traditional tech, how would you know that you are interpreting the numbers meaningfully? My understanding is that the (accurate tech's) reading is informative mostly if it's very high of very low compared to some statistical range, and only if analyzed by an expert on the lookout for other patterns -- and possibly only if the patient is feeling unwell. E.g. if your tests show that you have high cholesterol but are feeling good, is your health bad? And on the other en

      • Re: (Score:2)

        by w3woody ( 44457 )

        It's the same argument (how do you, a stupid layman, interpret the results?) that got 23andMe knocked off the air.

        Thing is, you can do your own blood tests in most states. It just happens to be expensive and not well known to most people. So Theranos didn't really change anything except improved the price point and increased availability. For those of us with the God-given common sense to (a) know how to use Google, and (b) to not panic when some number is 5% high or 5% low--and notice most blood tests nowa

  • Cult of personality? (Score:5, Insightful)

    by Facekhan ( 445017 ) on Monday December 28, 2015 @11:45AM (#51195437)

    After reading TFA, it seems like the company runs like a cult of personality of Ms. Holmes. Their answer for every objection is to impugn the integrity or intelligence of the person who raised the issue. Their remembrance of the facts diverges wildly from the first hand accounts of their critics. Whenever they mention Ms Holmes odd behavior, they basically make the No True Scotsman defense, that Ms Holmes would never do that. That is classic cult-like behavior.

    I can't get my head around how they raised so much money with nothing but the most basic outline of an idea and not even an original one. Score one for political connections.

    I smell something funny, but I don't think they have a test for that at Theranos.

    • Re: (Score:1)

      by Anonymous Coward

      Blonde, pretty face, nice tits, serviceable ass. Sorry to be crude but 99% of VCs are comprised of middle aged males who ain't getting any at home.

      Captcha: follows

    • Re: (Score:3)

      by Nidi62 ( 1525137 )

      After reading TFA, it seems like the company runs like a cult of personality of Ms. Holmes.

      Do a Google image search of her. It's like Steve Jobs had a sex-change operation: nothing but black turtlenecks. She most likely was trying to build a cult of personality around herself because that's how Jobs got so successful. I would say that hopefully she goes away for fraud because of this, but for a 19 year old to get millions in VC funding means that she was already well connected to begin with, so I doubt that will happen. On the bright side, with the recent uproar surrounding Shkreli, that fact

    • No doubt a future episode of American Greed [cnbcprime.com] will be featuring Theranos. Ms. Holmes is an interesting character as all such individuals are at some level. What I would like to know is how she convinced a rather stellar list of individuals [theranos.com] to become involved with her company.

      • Ms. Holmes is an interesting character as all such individuals are at some level. What I would like to know is how she convinced a rather stellar list of individuals to become involved with her company.

        It's no mystery. Peoples' brains shut down when the prospect of huge riches are dangled in front of them (provided they get in on the ground floor, of course). Many con artists have scammed people out of millions with far less than what Theranos has disclosed.

        As a case study, Google the story of Madison Pri

        • As a case study, Google the story of Madison Priest

          A very good example that people with money are often not smart. The decision makers must have had access to technical advisers. Either they ignored them, or they never asked them, substituting their own judgement for that of people with more knowledge. It's a little like the Dunning-Kruger effect. People who have money and/or power think that they got it because they are smart, whereas it is more likely that they got it because of connections or simple ru

    • Re: (Score:2)

      by lucm ( 889690 )

      I can't get my head around how they raised so much money with nothing but the most basic outline of an idea and not even an original one.

      Here's how they raise money: their business model is TRULY disruptive. It's not an ad-supported gimmick or a pretty website on top of existing local services. What they propose (and currently do) is to make blood tests that cost a lot less than what current private labs charge.

      The whole Edison thing with sophisticated disease detection is just a small part of it, and that's not what they sold investors. It's gravy R&D on top of their bread & butter.

      Just look at their website, you'll see stuff like t

      • Re: (Score:1)

        by Anonymous Coward

        They're not selling a fake tricoder, they're doing lab tests for less.

        The problem is that the lab tests are not giving the correct results. Anyone can take a drop of blood and run it through a magic machine that doesn't do what it claims to do.

        • Re: (Score:2)

          by lucm ( 889690 )

          The problem is that the lab tests are not giving the correct results.

          Can you support that with more than the WSJ's claims, which are based on testimonies from ex-employees (including one who worked there for 2 months in 2005) and misrepresented statements from various sources, many of which came forward to contradict the way they were quoted in the article?

  • Data Manipulation by *Thanos*. Much more sinister.

  • ... Gas the rich!!

  • Use of commercial clinical analyzers? (Score:3)

    by Steve1952 ( 651150 ) on Monday December 28, 2015 @02:28PM (#51196621)
    Commercial clinical analyzers are programmable by the end user. Thus, for example, it is possible for company "X" to purchase commercial clinical analyzers, put it's own programs on them, and say that "samples are being run on company X's proprietary systems". However if company X is also representing that it has proprietary clinical hardware, confusion might result. That is, a statement that "samples were run on company X's proprietary systems" would not enable outside readers determine if either commercial hardware or proprietary hardware was used. I am not sure if the press understands this.

  • Scam company (Score:5, Insightful)

    by pesho ( 843750 ) on Monday December 28, 2015 @04:23PM (#51197369)
    I can't believe they are valued at ~10billion. They raise some telling red flags:
    • 1. Board of directors with no expertise in the product their are making. Their board of directors is more suited to head a military invasion of a third world country than a biotech company (two former Secretaries of State, Kissinger and Shultz, a former Secretary of Defense and couple of retired generals).
    • 2. They claim huge improvement in sensitivity (I am reading about two logs better sensitivity compared to traditional tests), but there is no information how this is achieved. Such improvement requires a radically different analytical approaches. Just miniaturizing the existing chemistries is not going to cut it.
    • 3. Their IP is protected by trade secrets rather than patents. This one actually is quite absurd for a company that needs FDA approval. FDA wants to know not only that your product works but also how it works before issuing an approval. Peer review of the research is part of the process. There is no way for them to go through the approval process and keep a trade secret.
    • 4. Virtually all the tests they perform are currently made by traditional tech. This may have changed, but initially they collected very small sample volumes. So they had to dilute their samples to do all the test, which increases the error and even the "classical" tests do not perform to specification when done by Theranos.

    Who the hell invests in a company with non-existing tech and incompetent board???

  • I think that in my 20+ years of technology that I have seen the same person over and over. They usually spend more time on the front covers of magazines than they do in the office. They woo investors that seem impressive because of their money but often these investors aren't usually in the business of investing in that type of business so their imprimatur isn't that impressive, landing them is but their backing it isn't.

    Then there is the "revolutionary" aspect. But there is no mention of the scientists w
    • Okay. I'll grant this comment has the sense of authentic and interesting points. We still need to address the fact that costs of all tests and drugs have soared 10 to 20 times in the last 10 years without any real increases in underlying costs in many cases. The way medical care is allocated costwise is not transparent.
      • I would say that there are two cynical approaches to this: One, the drug companies shut her down for cutting into their pie. Or two, she wanted a taste of the big pie and like the bank robbers once said, "That is where the money is."
  • Why would the medical industry want to attack Theranos? 1) the standard array of blood tests I get 2 times every year for the last 20 years (quantified geek) have gone from 200$ to $3000 over that time. That's right. With technology improvements basic tests have climbed 15 times in cost. Why? I think it is how hospitals and clinics recover money they lose on other services like the famous $1000 toilet seat they just allocate essentially an arbitrary cost it has nothing to do with actual cost. Whatev

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