Theranos Revisited - How did it get to this stage?

I'm trying to understand what I'm looking at here, as the observations appear to contradict each other, so I'm clearly missing something.

Overview from my understanding (and feel free to correct anything I get wrong), is new blood test that is super accurate and cheap to do revolutionises blood test industry, opening up new possibilities to everything. Holmes was a genuine inspiration for me so I wanted to believe.

So far, so good.

Influential board members (check)
Investments flooding in (check)
actual sales and big name customers (check)

and now a warning from CMS that one lab was inadequately (quality) staffed. Ok fair enough, possible. They made changes and that doesnt seem to have made anything happier (if you're threatened with closure you go beyond the extra mile to rectify these complaints surely?) a criminal investigation just launched about misleading investors about its technology, accuracy of its tests.

What I don't get, is there's big money behind this. There's big names. How have they been duped so badly? and how has it been able to go on for so long if it doesnt work? and if it does, how come they're not passing these tests with flying colours.

IT starting to look a bit iffy:

secretive technology: fair enough in this day and age, but science is collaborative.
continuing from the above: i could understand the secretive nature, but if I was EH, then I would do a very public trial where someone (x100)donates an armful of blood, and then she takes a thimbleful, and gets the same results as the other guys do from the armful. Real results, impossible to cheat on. However this hasn't been done (to the best of my knowledge).
an unusual Board of directors (state secs. def secs, ex military).

So ultimately, there's 3 possible situations we're looking at.

1) The tech works, it's just been poorly managed.

2) The tech kinda works, needs a bit of tweaking, and they're trying to get it done before they get too far down the rabbithole, and have too many big names invested in to make this information known, the typical, fix it before they suspect it.

3) The tech doesn't work and she's duped a very convincing list of names and companies, who are going to have to save face somehow on this.

I'd like to believe it's 1, but my head is telling me its closer to 2 or 3.

 

Appears to be completely fraudulent.

As to why people were duped, it's pretty simple. It's a combination of several factors. First, she had an enormous board comprised of names that appear to have been selected for "prestige" rather than them knowing jack shit about business...let alone that technically advanced a line of business. Second is that there's a huge cult of personality around her. Half the press was fawning over her desperate to find their "female Steve Jobs" to idolize and no small number of VC's wanted to screw her.

Hell you said it yourself:

Holmes was a genuine inspiration for me so I wanted to believe.
 

Definitely something wacky going on there...Holmes' behavior makes me suspect that she's hiding something.

From Bloomberg: “We’ve taken the approach of saying, ‘Let’s rebuild this entire laboratory from scratch so that we can ensure it never happens again,’” Holmes said on the show. “I feel devastated that we did not catch and fix these issues faster.”

That was before the SEC announced their investigation. Why didn't they rush to fix the issues, even after negative reports were published in the WSJ?

 

The board was the first red flag, tottaly crazy to have those kind of outsiders and that number on a Vc owned company. Clear attempt to get some kind of fraudulent cachet

 

Not to be the Monday morning quarterback, but I never liked Elizabeth Holmes the moment I watched her being interviewed.. and it wasn't because she was a woman or anything else - something was just off about her, all I could think was what sort of sociopath is she?

 

I didn't watch the interview, but the moment CMS gets involved, it should be evident that there are significant problems. Although I questioned the tech from the get go, the CMS involvement is really what makes this entire matter look like it fits in the third category. I found a copy of the letter CMS sent to Theranos and the allegations are not indicative of number 1 and 2. Getting hit one one violation is a pain in the ass. Getting hit with all 5 is a severe breach of CLIA guidelines; the odds of that are astronomically low. And these are not minor charges - we're talking charges that there was incompetent management in charge of the lab, there were problems with the hematology systems (which is any lab's bread and butter. The fact that there were problems with the hematology systems should really sound the alarm as to whether or not Theranos had any real new tech or was using industry standards), and testing problems. If these were issued as a result of the magic box that Theranos has, this would be one thing and correctable without causing such a commotion, but I doubt it is as I'm sure these guys have a robust lab with all sorts of blood testing equipment (any equipment from Seimens, Sysmex, Beckman Coulter, and whatnot). The more I think about it, I really do think it's fraud. Plus, now I'm kind of interested in wondering how this lab got CLIA accreditation in the first place because who ever gave them the OK definitely has egg on their face.

Look, I get it that there are bad labs out there, but this is one of those times where everything looks like it's pointing to fraud. I seriously think she stacked her board with people who wouldn't know shit and was able to use their connections to get overpriced contracts to keep her in business. Of the members of the board, only two had any ties to healthcare (Former Sen. Majority Leader Bill Frist, who is a doctor and a large stakeholder in HCA, and William Foege, the epidemiologist who helped eradicate smallpox). For most companies, this wouldn't stand, especially with tech like this.

 

Same as any other startup and business scam: They're selling dreams and ideas, not feasible products.

It's a textbook case of where some charismatic entrepreneur/business person (though Elisabeth Holmes is the most charismatic around) wants to build a pipe dream, and iron out those pesky technical details later. The question is; Had she any idea how difficult the technology would be? Or did she just go for the money? Ignorant or Intentional, I don't know which one is worse.

You can say what you want, but even the most hardened and cynic investors have a soft-spot where rational thinking goes out the window. It's human. And it was a perfect unicorn candidate.

There's a reason kickstarter pages are filled to the brim with snake-oil salesmen and con-men. People don't think, and they want to believe.

edit: Let's not forget Meredith Perry, founder and CEO of uBeam. Total and utterly clueless fraud that one day decided "I'm gonna make mobile charging wireless, with sound", and got over 20 million in funding from people like Mark Cuban, Marissa Meyer, etc. Even HS AP Physics pupils know that the idea of using (ultrasonic) soundwaves to generate power will be terribly, horribly inefficient. 3.5 years later, and surprise! No product, nothing. Every scientist and engineer in the EE community has debunked it application.

Go watch her TEDx talk:

She's the personification of that mentality. No need to obey any physical laws, no need to listen to those damn Engineers or Scientists. If you just want something hard enough, it can be done! Anything!

 
 

Since this is the industry that I work in the things that stand out the most is the company knowing that the products did not meet their acceptance criteria, this is what is filed to the FDA, this is reviewed by the FDA and then their licence is given to them to sell their products. Most people who work in QA can spot the problems right away because a failed test is a failed test, the problem in my view is that the information is always passed up to senior management and this is where the politics of making money starts to rot the company. When one is talking to a senior managment and they use their influence to shut a person up or even demote them, this seems to be the problem, plus a large members of the board where not qualified in understand regulatory compliance, this has not been the first time that a company like this has got in trouble, Johnson and Johnson, merck, pfizer etc have had similar problems, but in this case the run for $$$$ was much higher. Now we have two years of voided tests, this will not end well for all parties.

Want to Lose the body fat, keep the muscles, I can help.
 

Theranos just sounds like the faceless dystopian biotech company.

to use the full phrase from poster above: "where ignorance is bliss, 'tis folly to be wise." I'll let y'all decide if $9B should warrant ignorance hehe

 
The company continued to trumpet its claim that the drop of blood in the Nanotainer could run 30 lab tests
I do not see how the Nanotainers are any different from blood collection tubes (for neonates) which are already on the market.

and deliver them efficiently to doctors, going as far as listing prices on its website for each test that were dramatically lower (by as much as 90%) than the status quo.

Now this portion on the other hand, seems to be the selling point for their product. The low cost of blood tests offered by Theranos would work really well to lower healthcare costs globally and could potentially penetrate parts of the world (e.g. Africa, India, etc.) which have poor access to these tests.

 

+1 Read an article about some big VC (can't recall name) that didn't invest because when they went to try the blood test process themselves, it proved to be a lot more complicated than they originally thought.
Wonder what the valuation of Theranos is going to be now.

 

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