Diagnosis

Much Hyped Theranos Diagnostics: Is It Vaporware?

Even worse, CEO Holmes evidently wants the FDA to regulate competing products

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TheranosHolmes
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I take biomedical diagnostic tests for fun. I have posted my genotype screening test results on the Internet for all to see. So I was really looking forward to taking advantage of the 240 diagnostic tests that startup Theranos promised could soon be run for cheap using just a couple of drops of my blood. Given how over-regulation has stifled medical advances, I was also looking forward to the massive disruption of health care system that Theranos was also promising.

Now comes a couple of articles in the Wall Street Journal which claim that Theranos' Edison diagnostic technology runs only about 15 tests and the accuracy of those are still in question. The Journal reports that most of the other tests offered by the company are run on standard lab equipment.

CEO Elizabeth Holmes is fighting back. She appeared on Jim Cramer's Mad Money show yesterday claiming that the Journal article is filled with mistakes and misreporting. She also asserted that her competitors in the lab testing industry planted the stories in an effort to discredit her company. I hope she is right, but her oddly evasive answers on the Cramer show were, let's say, somewhat less than convincing.

One other comment made by Holmes on Mad Money caught my attention: she wants all diagnostic tests to go through FDA approval before allowing them to be used by doctors and patients. This provoked me to go look up her July 28, 2015 Wall Street Journal op-ed, "How to Usher in a New Era of Preventive Health Care." In that op-ed Holmes said a lot of great things about the power of technology to drive down costs and free individuals from medical paternalism: 

Innovation needs to be unleashed. The improvements that technology and innovation could bring to health care are limited only by the imagination. But the technological progress that brought us the personal computer, the smartphone, the car was powered by consumer choice and free access to information in the market. That will be true in health care as well. …

Empowering individuals to engage in their own health, including through ordering their own lab tests, means the prices of these services will increasingly become transparent. Transparent pricing and consumer engagement allow markets to function, driving competition and innovation for higher-quality and lower-cost services. …

You have a fundamental right to access information about your own health. And you should be able to access that information when it matters most—when there is still time to change your life, and the lives of those you love, for the better.

The answers to our challenges in health care lie in the individual. By empowering individuals to engage in their own health, we can build a preventive care system in America—and a world in which fewer people have to say goodbye too soon.

Well, hooray and huzzah! But wait…in the same op-ed Holmes argued:

All lab tests should undergo review by the Food and Drug Administration. Given the pivotal role of labs in medicine, consumers need to trust the quality and accuracy of the tests they get. The FDA sets the gold standard for quality assurance. Its review is data-driven, objective and uniquely rigorous. …

The FDA recently proposed requiring laboratories to submit their tests for review. The proposal should be adopted. And Congress should provide the agency with the funds to exercise this oversight.

That's not very disruptive. In fact, such a requirement is just another old-fashioned rent-seeking barrier to entry for competitors.

Unleashing the regulators at the FDA is no way to unleash innovation. Just ask the folks at 23andMe whose innovative genotype screening tests were blocked by FDA regulators. How? The agency claimed that the vials used by 23andMe to collect saliva for testing were medical devices subject to FDA approval.

As it happens, the Journal is reporting today that FDA inspectors have shown up a Theranos and are claiming that the company's "nanotainers," the small vials used to collect blood from pricked fingers are also unapproved medical devices.

I do really hope that this is all a big misunderstanding and I will soon be a happy customer of Theranos' disruptive technologies. Stay posted.

NEXT: Hectoring Truth Be Told Forgets the 'Com' Part of 'Sitcom'

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  1. I take biomedical diagnostic tests for fun

    Let’s see the video of your colonoscopy.

    1. Tmgb: Alas, I have only stills.

      1. Stills or it didn’t happen.

        1. I’m holding out for the wacky gifs.

          1. A polyp with the rage guy photoshopped onto it?

      2. Wha….uehh…. is that a gerbil?

    2. Sigmoidoscopies are much more entertaining, primarily because you’re wide awake for all the indignities.

  2. she wants all diagnostic tests to go through FDA approval before allowing them to be used by doctors and patients.

    You’re not legit until you get a stamp of approval by government. You ain’t married, you ain’t in love, and you ain’t in business.

    1. She has to say this for 2 reasons.

      1. Nobody trusts the new tech – rightly so given the examples of bad results in the article.

      2. They can probably make more money selling the machines than the tests – but not until they prove they can be FDA approved.

      1. All lab tests should undergo review by the Food and Drug Administration. Given the pivotal role of labs in medicine, consumers need to trust the quality and accuracy of the tests they get. The FDA sets the gold standard for quality assurance. Its review is data-driven, objective and uniquely rigorous. …

        The FDA recently proposed requiring laboratories to submit their tests for review. The proposal should be adopted. And Congress should provide the agency with the funds to exercise this oversight.

        She has to say this for three reasons – saying “good doggie” to the foaming-at-the-mouth rabid beast who sees its job as keeping you the hell out of its turf is just good business. You really expect some little company trying to squeeze past the FDA to draw attention to itself by talking loudly about what a fat fucking piece of shit the FDA is?

          1. I second that.

  3. The answer to your headline question is “yes”. For the most part the technology is no better than existing labs.

    As the WSJ noted yesterday, they cannot reproduce results from their tiny-sample Edison machines with standard lab equipment. So until they can get their new technology to work, they are just a massively expensive start-up lab in an industry that is not growing.

    The other problem is their draws. No needle-sticks, instead a lance to your fingertip which hurts a lot more. Doesn’t sound like a break-through to me.

    1. instead a lance to your fingertip which hurts a lot more

      Suck it up, buttercup.

      1. Hey, _some_ of us get paid for what we do with our fingertips. We try not to damage the moneymakers needlessly.

        Plus, owie, lances hurt.

        1. Hand whore?

          1. The preferred term is ‘hand escort’

          2. They’re not like those face and body boys

          3. I’m waiting for congress to get around those damn Republican obstructionists and finally pass the Handjobs Bill.

            1. If you like your handjobs, you can keep your handjobs.

        2. I’m an “administrative assistant,” so I hear you. Even so… a little fingertip prick ain’t no thang.

      2. Just take the needle like a man.

    2. I was happy when the Red Cross switched from the stabby things to the slicey things. The slices are less painful and heal faster.

      1. I’d much rather take a needle to the arm than anything to the fingertip.

        1. 10,000 volts straight to the scrotum for this guy.

          1. Talk about riding the lighting…

          2. Well, it _is_ Friday night, I suppose…

  4. Quoting the Magic 8-Ball,

    Outlook not so good

  5. What’d Theranos do, Bailey? – touch a heating element to a petri dish filled with your blood while you were tied up in a chair?

    1. The rest of the reason staff held their breath until it fizzled. When Suderman’s blood screamed and jumped out of the dish is when all he’ll broke loose.

      1. HELL, all HELL broke loose.

    2. +1 Spider Head

  6. The FDA sets the gold standard for quality assurance.

    She says it like that’s a good thing. If the FDA represents the best in quality control then we’re all fucked.

  7. RB, they’re supposed to be open for business in a few places at Walgreens in the southwest. Give him a call and see what test they offer?

    Better yet fly out there on the expense accounts and take all the tests they offer.

  8. i blame the patriarchy

  9. I recommend evaluating the CEO’s statements in the same way you evaluate the statements of any hostage in a hostage situation.

  10. “Oddly evasive answers”

    Would be nice to see some examples. I guess I’ll sit through the 10mins to see if there’s any “There” There. (*note: she’s got a …handsome… voice)

    Some of her quotes from the Mad Money show are less than encouraging

    “”we are doing things differently and we are working to make a difference and that means people raise questions, and that’s okay””

    Fucking hell if that’s not vapid mish-mash of millenialfeels.

    Fwiw, rather than some breakthrough technology ‘revolutionizing’ the medical industry… it would be far easier to simply remove the layers of bureaucracy and let the powers of cost-benefit work their magic.

    re: her evasiveness… she pulls an Obama saying things like, “We proved their points were false”, but never names what these points were or what the countervailing facts are. Its just He Said/She Said.

    of the “evasiveness”,

    – she completely dodges the “why did you refuse to talk to them for 5 months, then claim they didn’t listen to your side of the story”

    – She sort of dodges the question about the “vast majority of tests being performed on standard diagnostic equipment” = her response is that, “whatever the means, we’re charging LESS for all these other tests”. Different point, but explanatory to a degree.
    Much of the rest just seems inconclusive, where she waffles on, re-framing the questions into things that are only tangentially related to what he asked. i.e. Political dodgeball

    1. Theranos isn’t publicly traded, but they presumably want to go public. And when they do, anything Holmes says on television could and would be used against her by investors–public or otherwise.

      People would definitely sue the hell out of the company for saying anything definitive that might be misconstrued, and there are plenty of agents at the SEC, the Justice Department, and various regulatory agencies in New York that would love to have her scalp on their wall.

      Regardless of whether Theranos accomplishes it themselves, this platform looks good to go in the future. Looks to me like it isn’t a question of “if” but a question of “when”.

      1. That wasn’t supposed to be a response. Just in the general thread…

        Has Hit & Run’s software been approved by the FDA?

        1. You think anything Agile Cyborg is hitting is approved by the FDA?

      2. I am pretty informed about Safe Harbor issues, and there’s nothing that should have really prevented her from being entirely candid about the merits of the WSJ piece the current status quo of her organization

        If there were any limits on what she could talk about, she would have/should have disclosed at the very top

  11. Also, I think Mr. Bailey might look to this Fortune article for reassurance:

    “Though Theranos has been offering hundreds of low-priced, fingerstick diagnostic assays commercially since late 2013?it has performed millions of tests for tens of thousands of patients, according to the company?it has not been, and still isn’t, required to seek FDA approval because of the way its business model works, which differs from those of incumbent diagnostic labs, like Quest Diagnostics DGX and Laboratory Corporation of America LH .

    Yet because of this difference, Holmes and her company have been subject to criticism from competitors and some others in the medical community for offering medically vital procedures to the public that the critics claim have been insufficiently vetted. Last February, for instance, Stanford School of Medicine professor John Ioannidis accused the company in a Journal of the American Medical Association editorial of engaging in “stealth research,” because it treats its novel methods as trade secrets, and has declined, for the most part, to air them in peer-review journals.

  12. On the other hand, Holmes has voluntarily submitted voluminous data and validation studies to the FDA on more than 120 of her tests so far?without any legal obligation to do so?in an effort to persuade that body to grant formal clearance to her methods. She has done so, she says, because she regards the FDA’s imprimatur as the “gold standard” for safety and effectiveness.

    http://fortune.com/2015/07/02/…..-approval/

    1. This may not be about rent seeking as much as it’s about trying to assuage the other rent seekers.

      If doctors are being told to question the validity of these tests by prestigious peers and prestigious journals, that would be really bad for business–and it looks like that’s what was happening.

      She’s not jumping for the FDA. She’s responding to accusations made against her tests by the Journal of the American Medical Association, and the AMA has the medical profession pretty much locked up.

      As an aside, Elizabeth, if you’re reading this, I’d really like to discuss your FDA issues with you in detail–preferably over drinks. I could even take you on a sail around Catalina. We could snorkel in Emerald Bay, I could teach you how to surf, or…maybe you like opera?

    2. ” Holmes has voluntarilysubmitted to arbitrary power of her FDA rulers, and submitted voluminous data and validation studies to the FDA”

      Fixed that for ya.

  13. I follow the medical device startup industry and investors have thrown a lot of money at Theranos, and my guess is that they have not done so without verifying the validity of what they are developing. They also have a huge staff working for them and machines installed in 42 locations around Phoenix Arizona (their launch/test market) so I think calling this vaporware is a bit much.

    1. Aren’t the 42 locations just for blood draws? Isn’t she a family friend of Larry Ellison who invested first and the other investors are just jumping on his band wagon?

  14. She should change the name to Theiranus because that’s where the investors have their heads.

    1. It’s a privately held company.

      I’d love the opportunity to get in before they go public.

      As an aside, Elizabeth, if you’re reading this, I’d love to go over the details of your business plan in person–preferably over drinks. Do you like sushi? Or I know a little place up in Calabasas where some well-heeled hippie types do Shakespeare in the forest. It’s a hoot. We could have a picnic…

      1. “As an aside, Elizabeth, if you’re reading this, I’d love to go over the details of your business plan in person–preferably over drinks. Do you like sushi?”
        Vegan, Ken.

  15. Holy crap what’s the deal with her voice? That’s a dude!

    1. See above = (*note: she’s got a …handsome… voice)

      it seemed to get better the more she talked. maybe her nervous-voice gets really deep

  16. I would be more impressed with the company if it did not have so many politicans/military on the board of directors

    https://www.theranos.com/leadership

  17. If the FDA sucked my hemorrhoids, would their lips be “medical devices”?

    Also, I’m pretty Government-Almighty-Damned sure that they DO suck my hemorrhoids all Government-Almighty-Damned day long, and I do NOT think they collectively have a physician’s degree, certification, license, yada-yada-yada!

  18. Google pay 97$ per hour my last pay check was $8500 working 1o hours a week online. My younger brother friend has been averaging 12k for months now and he works about 22 hours a week. I cant believe how easy it was once I tried it out.
    This is wha- I do…… ?????? http://www.buzznews99.com

  19. No, I am.

  20. Google pay 97$ per hour my last pay check was $8500 working 1o hours a week online. My younger brother friend has been averaging 12k for months now and he works about 22 hours a week. I cant believe how easy it was once I tried it out.
    This is wha- I do…… ?????? http://www.buzznews99.com

  21. Start working at home with Google! It’s by-far the best job I’ve had. Last Wednesday I got a brand new BMW since getting a check for $6474 this – 4 weeks past. I began this 8-months ago and immediately was bringing home at least $77 per hour. I work through this link, go? to tech tab for work detail,,,,,,,

    http://www.onlinejobs100.com

  22. Start working at home with Google! It’s by-far the best job I’ve had. Last Wednesday I got a brand new BMW since getting a check for $6474 this – 4 weeks past. I began this 8-months ago and immediately was bringing home at least $77 per hour. I work through this link, go? to tech tab for work detail,,,,,,,

    http://www.onlinejobs100.com

  23. Google pay 97$ per hour my last pay check was $8500 working 1o hours a week online. My younger brother friend has been averaging 12k for months now and he works about 22 hours a week. I cant believe how easy it was once I tried it out.
    This is wha- I do…… ?????? http://www.buzznews99.com

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