Scientists skeptical about Theranos blood test(businessinsider.com)
businessinsider.com
Scientists skeptical about Theranos blood test
http://www.businessinsider.com/science-of-elizabeth-holmes-theranos-2015-4#ixzz3YO784nGj
14 comments
they probably excluded all the boring and reasonable parts of the story
>When she was 9, her family moved to Houston, where her father had taken up a job with Tenneco (Oil Company). Intrigued by their father's work in China, Elizabeth and her brother learned Mandarin Chinese at a young age.[5] She spent her teenage years in China, and while still in school, started a business selling C++ compilers to Chinese universities.[8][5]
http://en.wikipedia.org/wiki/Elizabeth_Holmes
>When she was 9, her family moved to Houston, where her father had taken up a job with Tenneco (Oil Company). Intrigued by their father's work in China, Elizabeth and her brother learned Mandarin Chinese at a young age.[5] She spent her teenage years in China, and while still in school, started a business selling C++ compilers to Chinese universities.[8][5]
http://en.wikipedia.org/wiki/Elizabeth_Holmes
The New Yorker had a good article that covers her background. http://www.newyorker.com/magazine/2014/12/15/blood-simpler
> Although she can quote Jane Austen by heart, she no longer devotes time to novels or friends, doesn’t date, doesn’t own a television, and hasn’t taken a vacation in ten years. Her refrigerator is all but empty, as she eats most of her meals at the office. She is a vegan, and several times a day she drinks a pulverized concoction of cucumber, parsley, kale, spinach, romaine lettuce, and celery.
Every time I read about these ultra successful people, I just think they are freaking machines... and I don't mean that in a derogatory or mean way.
I am genuinely amazed people can operate like that. I know I can't.
Every time I read about these ultra successful people, I just think they are freaking machines... and I don't mean that in a derogatory or mean way.
I am genuinely amazed people can operate like that. I know I can't.
Her story is quite comparable to Bill Gates. She's levelled up compared to her parents but they were by no means poor.
I hope I'm proved wrong, but it does sound too good to be true.
[deleted]
Seriously? Just because you can't imagine it, it must be a scam?
Yes, clearly that is exactly what I'm saying. Intelligent CEO == scam.
It takes more than intelligence to start a Biotech company. You need money, equipment, skill, and usually experience.
Medical breakthroughs usually require years of research and skills that are acquired working on a PhD. I'm not saying it's not possible for a 19 year old to make a world changing discovery, but when no one will say what exactly that world changing discovery is, I get a bit skeptical.
It takes more than intelligence to start a Biotech company. You need money, equipment, skill, and usually experience.
Medical breakthroughs usually require years of research and skills that are acquired working on a PhD. I'm not saying it's not possible for a 19 year old to make a world changing discovery, but when no one will say what exactly that world changing discovery is, I get a bit skeptical.
Actually, there does not need to be a 'discovery' here, merely fantastic execution on existing technology. It's a bit like combining a bunch of stuff that already exists in a novel way and then playing that for all it is worth. This does nothing to belittle the accomplishment here, it's fairly amazing if what they've done is as accurate as they claim it is but from what I've been reading over the years all the pieces were already there, it's just that nobody bothered to combine them like this and the execute the hell out of it.
Classic disruptive startup, very impressive if you dig down a bit further.
Classic disruptive startup, very impressive if you dig down a bit further.
>Classic disruptive startup,
I don't think you can call this a classic disruptive startup. Look at the board members; they are some of those most powerful people on the planet, and yet the founder still maintains 51%.
Either she is insanely charismatic or she discovered something earth shattering (either a novel discovery, or a novel use of existing discoveries).
I don't think you can call this a classic disruptive startup. Look at the board members; they are some of those most powerful people on the planet, and yet the founder still maintains 51%.
Either she is insanely charismatic or she discovered something earth shattering (either a novel discovery, or a novel use of existing discoveries).
…insanely charismatic or… discovered something earth shattering…
Or just kept executing well.
The company is 12 years old. The initial investments and staffing were likely modest and provisional.
But going back to investors year after year, always having delivered what you predicted at each step, and proving that you've accumulated proprietary technical advantages, will get you to a giant company.
Or just kept executing well.
The company is 12 years old. The initial investments and staffing were likely modest and provisional.
But going back to investors year after year, always having delivered what you predicted at each step, and proving that you've accumulated proprietary technical advantages, will get you to a giant company.
>The initial investments and staffing were likely modest and provisional.
The initial investment was $16 million from what I've read. That's a lot of money to give to then 20 year old with no record whatsoever.
The initial investment was $16 million from what I've read. That's a lot of money to give to then 20 year old with no record whatsoever.
When you say, "no record", it seems you haven't read (among other things) the New Yorker profile linked above.
Per that account, by the time Theranos raised its first $6 million in late 2004, Holmes had been working on it for over a year, had at least one patent in process, and had convinced her chemical engineering professor, a dean of the Stanford engineering school, to be an advisor and board member. (He's since joined Theranos full-time.)
So it's not, "kid with nothing but idea and moxie handed money" – but rather "star researcher impresses and recruits a bunch of domain-experts, which then attracts investments".
Per that account, by the time Theranos raised its first $6 million in late 2004, Holmes had been working on it for over a year, had at least one patent in process, and had convinced her chemical engineering professor, a dean of the Stanford engineering school, to be an advisor and board member. (He's since joined Theranos full-time.)
So it's not, "kid with nothing but idea and moxie handed money" – but rather "star researcher impresses and recruits a bunch of domain-experts, which then attracts investments".
I have read that, and to me that is "no record". By record, I mean a demonstrated ability to actually turn an idea into a product.
When she got that first $6 million, and another $10 shortly after, she had no product, no experience, and it wasn't even clear if the technology to do what she proposed was feasible.
I've read her first patent, it's super broad and covers a huge number of possible implementations. There was no way for her to know at the time if any of it was really feasible. And none of it was feasible at the time--it just wasn't ready yet as evidenced by the fact that it took 10 years before anyone heard anything about it.
It took 11 more years of research to get to anything remotely commercially viable. She basically convinced people to pay her to do 11 years of pure R&D. Name me one other founder who has been able to do this with no academic credentials, and no record of success--much less a founder who was 20 at the time.
>"star researcher impresses and recruits a bunch of domain-experts, which then attracts investments"
She wasn't a star researcher at the time. She had almost no formal training, no publications, and a year of experience as an undergraduate.
Edit: I'm not the only one who is very skeptical.
http://pathologyblawg.com/pathology-news/new-yorker-theranos...
When she got that first $6 million, and another $10 shortly after, she had no product, no experience, and it wasn't even clear if the technology to do what she proposed was feasible.
I've read her first patent, it's super broad and covers a huge number of possible implementations. There was no way for her to know at the time if any of it was really feasible. And none of it was feasible at the time--it just wasn't ready yet as evidenced by the fact that it took 10 years before anyone heard anything about it.
It took 11 more years of research to get to anything remotely commercially viable. She basically convinced people to pay her to do 11 years of pure R&D. Name me one other founder who has been able to do this with no academic credentials, and no record of success--much less a founder who was 20 at the time.
>"star researcher impresses and recruits a bunch of domain-experts, which then attracts investments"
She wasn't a star researcher at the time. She had almost no formal training, no publications, and a year of experience as an undergraduate.
Edit: I'm not the only one who is very skeptical.
http://pathologyblawg.com/pathology-news/new-yorker-theranos...
Then, it's probably a good thing those scientists and investors back in 2004 trusted their own expert judgements about what a suitably promising "record" would be, after actually meeting her and reviewing her proprietary research.
Had they waited for the decade-later opinion of a layperson web-developer who's skimmed the first patent abstract, they might have missed out.
Had they waited for the decade-later opinion of a layperson web-developer who's skimmed the first patent abstract, they might have missed out.
It's a good thing that another layperson web-developer is on hand to let them know that their investment, which still hasn't made a profit after 11 years, and has no credible evidence that it ever will, was a wise decision.
What the company does now has almost nothing to do with her original patent applications, so it looks like her original proprietary research didn't amount to much.
They paid a smart person millions of dollars to essentially build a research lab. And after 11 years of research, they now have a way to maybe do some blood tests with a finger prick instead of a blood draw. But there are still questions remaining about the accuracy of these very small sample sizes. Some of the doctors and lab techs opinions I've read, say that even if the technology is flawless small finger drawn samples are much more prone to contamination. The article mentioned on HN even mentions that their tests would be more sensitive to inaccuracies caused by poor operator technique.
How many PhDs out there could have done something similar with 11 years and $400 million.
There are also plenty of experts who are skeptical of Theranos' claims. http://pathologyblawg.com/pathology-news/new-yorker-theranos...
Also you can read here about a first hand account of their procedures. It doesn't sound nearly as revolutionary as the hype is making it out to be. http://decibio.com/blog/theranos-small-sample-big-opportunit...
What the company does now has almost nothing to do with her original patent applications, so it looks like her original proprietary research didn't amount to much.
They paid a smart person millions of dollars to essentially build a research lab. And after 11 years of research, they now have a way to maybe do some blood tests with a finger prick instead of a blood draw. But there are still questions remaining about the accuracy of these very small sample sizes. Some of the doctors and lab techs opinions I've read, say that even if the technology is flawless small finger drawn samples are much more prone to contamination. The article mentioned on HN even mentions that their tests would be more sensitive to inaccuracies caused by poor operator technique.
How many PhDs out there could have done something similar with 11 years and $400 million.
There are also plenty of experts who are skeptical of Theranos' claims. http://pathologyblawg.com/pathology-news/new-yorker-theranos...
Also you can read here about a first hand account of their procedures. It doesn't sound nearly as revolutionary as the hype is making it out to be. http://decibio.com/blog/theranos-small-sample-big-opportunit...
Theranos reports being cash-flow positive, with customers in hospitals, drug companies, and the US military (in addition to their retail blood testing).
I'm not affiliated with Theranos, but I see that they are hiring for a large number of open positions, including some related to your areas of professional expertise: https://www.theranos.com/careers/software-development
I'm not affiliated with Theranos, but I see that they are hiring for a large number of open positions, including some related to your areas of professional expertise: https://www.theranos.com/careers/software-development
This is not a new company and that board was not in place from day 1.
If you've got the money, you too can have a board like that.
If you've got the money, you too can have a board like that.
Yes, but why do they have so much money? So a 19 year old walks up to an investor and says:
"Give me $16 million. I've got an idea for a new way to do blood tests. It doesn't work yet, and I've got less than a year's experience in the field. But I'm wicked smart because I learned Mandarin as a child, and my professor believes in me. Oh and by the way I'm going to maintain control of my company and never want to give up more than 50%"
That surely didn't happen. She must have something that at least looks very impressive to have negotiated those terms, but what I don't understand is why no one is talking about what that is. They have patents to protect them. Why aren't they releasing peer reviewed studies?
"Give me $16 million. I've got an idea for a new way to do blood tests. It doesn't work yet, and I've got less than a year's experience in the field. But I'm wicked smart because I learned Mandarin as a child, and my professor believes in me. Oh and by the way I'm going to maintain control of my company and never want to give up more than 50%"
That surely didn't happen. She must have something that at least looks very impressive to have negotiated those terms, but what I don't understand is why no one is talking about what that is. They have patents to protect them. Why aren't they releasing peer reviewed studies?
They have so much money because there is lots of money to be made in this field and they have a pretty compelling story.
Also, those investors have likely done their due diligence and liked what they saw.
Also, those investors have likely done their due diligence and liked what they saw.
A compelling story doesn't buy $16 million for a 20 year old with no track record, no product, no customers, and no experience.
From further reading, her initial idea was just that, an idea. She thought it would be possible to make a handheld device that could do blood tests.
How you go from that to $16 million without the slightest demonstrated ability to execute is my question.
From further reading, her initial idea was just that, an idea. She thought it would be possible to make a handheld device that could do blood tests.
How you go from that to $16 million without the slightest demonstrated ability to execute is my question.
> From further reading, her initial idea was just that, an idea. She thought it would be possible to make a handheld device that could do blood tests.
Reminds me of: https://www.youtube.com/watch?v=DkGMY63FF3Q
Reminds me of: https://www.youtube.com/watch?v=DkGMY63FF3Q
Money attracts money. This is perhaps the long-tail of the investment insanity which happened over the past decade and culminated in the GFC for the finance sector. It somewhat stands to reason that the fiscal fervor of the times has perhaps just fallen into an area where the payoff period is typically longer.
There's a very good reason to be skeptical when the most anyone can say about the company is the composition of it's board - noteworthy, but I wonder how often that was used to pitch to each of its members.
It's worth rereading the story of Enron when parsing things like this - there's a lot of parallels.
There's a very good reason to be skeptical when the most anyone can say about the company is the composition of it's board - noteworthy, but I wonder how often that was used to pitch to each of its members.
It's worth rereading the story of Enron when parsing things like this - there's a lot of parallels.
Given what has occurred elsewhere in the economy in recent years, the fact that people have thrown lots of money at a compelling story means nothing without being able to look inside the box to see what is going on, Bernie Maddox managed to get a lot more money raised than these folk.
You don't raise that kind of money without DD. So presumably somebody got to look inside the box but they did not make it public. That's pretty common in the tech investment world.
Presumably someone did, but it would not at all be unheard of for due diligence to not be particularly diligent at all and for later investors to then trust to the diligence of the earlier ones, as after all, being thoroughly diligent is exceedingly expensive and why double up when someone else has already checked...
I would agree that you usually do not raise that kind of money without reasonable DD, but there are more than enough counter examples out there of people bullshitting investors out of very large sums, both deliberately and through deluding themselves.
I would agree that you usually do not raise that kind of money without reasonable DD, but there are more than enough counter examples out there of people bullshitting investors out of very large sums, both deliberately and through deluding themselves.
That does happen but less frequently than you probably think. In this case there was a company with a track record and a bunch of tech which could be audited, that's a relatively straightforward affair. It gets a lot harder in early stage 'virtual' (as in: no physical product) companies.
Impressive that a founding student (not the professor who sponsored the research) has retained 50% equity at a $9B valuation. The history of those negotiations will hopefully become a Harvard or Stanford Business School case study.
Her family connections might had something to do with it. Its easy to screw poor kid, but Oil executive family that regularly has Secretary of State, a former Secretary of Defense, and a former Senator dinner guests? Better think twice.
What stops the skeptics from doing their own tests by walking into a service center and having their blood analyzed for all tests possible and doing the same with their blood for conventional tests? Or an even large scale test?
If their concern is genuine (rather than a way to get a look under the hood of a competitor for the current sellers of such services) there are multiple ways in which they could get their verification without inside information on how Theranos does its thing.
If their concern is genuine (rather than a way to get a look under the hood of a competitor for the current sellers of such services) there are multiple ways in which they could get their verification without inside information on how Theranos does its thing.
Exactly. This is what I was hoping for from an investigative piece on Theranos. Even an n=1 sample where the author had his or her blood tests done with Theranos and a competitor would be worth more than all the speculation in this article.
I don't think an n=1 test would be useful. Depending on people's preconceived biases, they would just say "see this confirms what I thought!" or "lol n=1 is meaningless". To do something conclusive, you'd need to do a real trial with n>>1. That costs way more money than Business Insider (or most other venues) is going to spend on an article.
Especially if such a test gave different results than the accepted competitors test.
But they would have to spend money on tests, wait for them to finish and there might be a possibility tests won't show what they hoped for(even if their hypothesis is true). While speculation is cheap, fast and always trueish enough to warrant an article.
You mean they to hope that the tests would work as advertised? After all we're all in it for the best of the patient and a decrease in healthcare costs or an increase in quality for the same price, right?
I think the demand is the company itself should be doing those tests and publishing them. I can't say I see a reason they didn't.
I'm not sure how available the tests are yet, but if it's available really anyone could test it. However, it requires a sample of a large diverse population to get statistical significance and that isn't cheap, which is why most academics probably aren't interested in doing it.
I'm not sure how available the tests are yet, but if it's available really anyone could test it. However, it requires a sample of a large diverse population to get statistical significance and that isn't cheap, which is why most academics probably aren't interested in doing it.
They don't need to prove it works, they only need to prove that it doesn't. That's related to how defenders need to close all the holes but hackers only need to find one to get in, proving that it doesn't work for a subset of the tests is enough to put a substantial hole in the boat.
Proving that it works is a much harder problem that probably only Theranos is willing to finance.
Proving that it works is a much harder problem that probably only Theranos is willing to finance.
In both cases it's going to be statistical though. If you find one instance of a flaw in the Theranos it'll be easy to challenge it by talking about variations in blood chemistry, blood draws, time of day, etc. Good controls can help, but unless you can bring a phlebotomist on site to wherever the Theranos is you're going to face external consistency issues.
So the right answer is to repeat the experiment. Perhaps many times. You'll end up with a statistical judgement of consistent inaccuracy and while it'll be easier to prove (in terms of statistical strength) than showing accuracy, it'll still be (a) reasonably expensive, (b) generalizable research, and (c) less punchy for headlines.
(b) is especially concerning because if you publish generalizable research involving humans, as would be the only way to do this, then you have to treat it like a legitimate clinical trial and are responsible for many more legal processes, e.g. IRB approval.
So the right answer is to repeat the experiment. Perhaps many times. You'll end up with a statistical judgement of consistent inaccuracy and while it'll be easier to prove (in terms of statistical strength) than showing accuracy, it'll still be (a) reasonably expensive, (b) generalizable research, and (c) less punchy for headlines.
(b) is especially concerning because if you publish generalizable research involving humans, as would be the only way to do this, then you have to treat it like a legitimate clinical trial and are responsible for many more legal processes, e.g. IRB approval.
Good point, I agree, but there is still margin for some errors. I believe a scientific journal would want a large number of tests, not a "Blood exam shown to fail once".
Proving reliability does rely on examining internal methods, and showing they are consistent and reliable.
I concur it somewhat lends to Theranos' credibility that no competitor is disproving their accuracy.
Proving reliability does rely on examining internal methods, and showing they are consistent and reliable.
I concur it somewhat lends to Theranos' credibility that no competitor is disproving their accuracy.
No the problem is no one can get their hands on a sufficient quantity of the tests in order to run such an analysis. This is not a cheap or easy exercise to do rigorously, and would require a fair amount of staffing to carry out properly.
The company being non-cooperative is it's right - it's just not good science.
The company being non-cooperative is it's right - it's just not good science.
It doesn't seem that hard or labor-intensive to me. Have volunteers who were going to have a battery of tests done at just one provider visit a second the same day. (At most, 2x the retail testing costs – but far less if any of the providers is a partner in the study.)
When the results come back, tabulate and compare.
If there are major discrepancies, they'd probably turn up in the first few dozen tests. But you could run this for hundreds of people with a single analyst, and just a few doctors soliciting their patients' participation, and without needing cooperation from Theranos.
When the results come back, tabulate and compare.
If there are major discrepancies, they'd probably turn up in the first few dozen tests. But you could run this for hundreds of people with a single analyst, and just a few doctors soliciting their patients' participation, and without needing cooperation from Theranos.
But that's not the problem: the problem is you need to study how the test behaves on given conditions. There's a serious issue that a bunch of the type of people you could recruit for such a study, are likely to have ordinary looking bloodwork. Designing a test which mostly gives results that show "ordinary" is actually fairly easy - designing one which correctly picks up unusual or important conditions is harder.
To be valid, you'd want to go in and supply a bunch of baked-samples which should produce a certain definitive result, without the tester knowing this in advance.
To be valid, you'd want to go in and supply a bunch of baked-samples which should produce a certain definitive result, without the tester knowing this in advance.
But suppose you were running this 2-channel validation constantly, for people with both routine and exceptional needs. You'd be getting fresh information, in exactly real-need/real-disorder proportions, from both the traditional and new tests, in the cheapest and fastest way possible.
Storing 'baked-sample' blood, or doing extra tests against people who weren't otherwise needing tests, couldn't possibly be as representative. Diverting a few drops from tests that are already going through the traditional process, for research/calibration purposes, is likely already authorized by existing patient relationiships. Your "n" for analysis, across any disorder or rare test, would quickly exceed what's "recruitable" for some formal study.
Look at the list of Theranos partners/customers who have brought them to "cash-flow positive": hospitals, drug companies, insurance companies, and the US military.
It's naive to the ways of industry R&D to assume that such constant cross-validation hasn't been (and isn't still) happening.
Storing 'baked-sample' blood, or doing extra tests against people who weren't otherwise needing tests, couldn't possibly be as representative. Diverting a few drops from tests that are already going through the traditional process, for research/calibration purposes, is likely already authorized by existing patient relationiships. Your "n" for analysis, across any disorder or rare test, would quickly exceed what's "recruitable" for some formal study.
Look at the list of Theranos partners/customers who have brought them to "cash-flow positive": hospitals, drug companies, insurance companies, and the US military.
It's naive to the ways of industry R&D to assume that such constant cross-validation hasn't been (and isn't still) happening.
Erm I don't understand the disagreement, I tried to argue pretty much the same as you. Maybe I didn't put it down too well.
Any such comparison wouldn't work for just an N=1. You'd need many more people before you could start to draw a conclusion about the Theranos test versus a conventional test. Just an individual doing this wouldn't be anything more than anecdotal at best.
I'm assuming they've done this study, but have refused to publish it for some reason. But this is the real question from the article - where is this study? You don't have to disclose the full technique for the test in order to publish the comparison.
I'm assuming they've done this study, but have refused to publish it for some reason. But this is the real question from the article - where is this study? You don't have to disclose the full technique for the test in order to publish the comparison.
Agreed, a n=1 test wouldn't reveal the most insidious kind of failure: guessing to cover up crummy data (err, I mean "leveraging machine learning techniques to maximize accuracy"). I doubt they're that evil, but it would be nice to know for sure.
> I'm assuming they've done this study, but have refused to publish it for some reason.
Because they're a bog-standard vertical integration play and if that fact comes to light before they are done using the hype train to raise money and grab market share then their competitive advantage will evaporate overnight. If they only release test results to interested parties under NDA it prevents public sector science from rebutting their claims to disruptive rather than incremental innovation, allowing the hype train to steam ahead unimpeded.
> I'm assuming they've done this study, but have refused to publish it for some reason.
Because they're a bog-standard vertical integration play and if that fact comes to light before they are done using the hype train to raise money and grab market share then their competitive advantage will evaporate overnight. If they only release test results to interested parties under NDA it prevents public sector science from rebutting their claims to disruptive rather than incremental innovation, allowing the hype train to steam ahead unimpeded.
You can't actually walk into a service center and order tests. You need a doctor to order them. This is one thing Theranos is trying to change: enable and simplify access to your own medical data.
Are you referring to blood tests, in general, or Theranos tests? I don't know about Theranos, but, in most places (in the US), you can order blood tests without a doctor's orders. See: https://www.directlabs.com/
I'm kind of perplexed why Apple needs FDA approval for their watch to measure blood oxygen, yet Theranos can develop a completely novel blood testing technique whose results could impact major medical decisions without having to conduct a single study.
(note that I'm not saying that Theranos hasn't conducted studies, rather the FDA doesn't require any)
(note that I'm not saying that Theranos hasn't conducted studies, rather the FDA doesn't require any)
'device' versus 'service'
Which implies Theranos only uses standard devices for their service, then?
Standard devices, or proprietary devices developed (and kept) in-house. The New Yorker profile suggests that FDA device approval only becomes necessary when devices are sold.
That is quite a loophole! If these blood tests are proved to be inaccurate, the lawsuits will be a plenty?
I have followed her career. In every Interview, she talks about the huge about of funding the company has received.
Why not perform double blind studies? Blood is sent to Quest Labs. Blood is sent to her companies machines. The results are collated by a third party. It seems like one of the easier studies to set up? It seems like a cheap way of proving her machine works as described? Plus, the company Lawyers could sleep at night?
I have followed her career. In every Interview, she talks about the huge about of funding the company has received.
Why not perform double blind studies? Blood is sent to Quest Labs. Blood is sent to her companies machines. The results are collated by a third party. It seems like one of the easier studies to set up? It seems like a cheap way of proving her machine works as described? Plus, the company Lawyers could sleep at night?
What if they did just that, then chose to not publish the results? That would be a really good strategy, you play your cards when you need to, on your terms rather than on the terms of your competitors.
It is because the FDA's prime mission is to protect the drug manufacturers from any non-drug competition.
The composition of the board has always bothered me. It's not at all clear what business value a lot of those people bring. Maybe opening certain doors, but I would've thought in such an area, as the article suggests, you would want more medical expertise.
That should be a little bit of a red flag to anyone - since the history of scientific fraud is full of lone specialists who couldn't brook explaining the technical details to anyone else qualified to understand them.
That should be a little bit of a red flag to anyone - since the history of scientific fraud is full of lone specialists who couldn't brook explaining the technical details to anyone else qualified to understand them.
It seems pretty clear to me and with the lack of peer-review and technical details paints a pretty disturbing picture. When I saw those names an image formed of a company gearing up to bend the government to its business objectives through its board's political ties.
Now, I'm not sure if that's because:
A.) They don't have a game changer or it's going to come under fierce scrutiny by the larger scientific community so they need to try to mandate its use through legal means and using the military as a gateway and OUR military budget as an early source of funds.
OR
B.) Even though they have the real deal, the nature of the political landscape in which medicine operates necessitates the back-room dealing that this board can deliver on.
Now, I'm not sure if that's because:
A.) They don't have a game changer or it's going to come under fierce scrutiny by the larger scientific community so they need to try to mandate its use through legal means and using the military as a gateway and OUR military budget as an early source of funds.
OR
B.) Even though they have the real deal, the nature of the political landscape in which medicine operates necessitates the back-room dealing that this board can deliver on.
Your staff should be experts, your board should be ambassadors.
Medical industry as I understand it employs all possible methods to curb competition. These include heavy political lobbying. The Washington heavy weights make sure their competitors cannot find enough political ammunition to curb them unless there is strong fact based evidence against their method.
It's also interesting there are so many foreign policy heavyweights, and many in a certain range on the political spectrum. I'm not suggesting some conspiracy, I just wonder why.
One big problem in the healthcare in africa, is the cost and complexity of blood tests. And we know lab-on-chip technology can fix that, but nobody is working on that, because of "business model" problems.
But that's one thing a successful theranos could do, and foreign policy is important at that.
But that's one thing a successful theranos could do, and foreign policy is important at that.
This is complete misdirection though. It has no relevance to a biotech company. If the test is cheap and easy, then charities and governments will carry it into Africa. There's no fiscal reason to pay people with foreign policy experience, because it has nothing to do with foreign policy. Its miles away from being relevant to the central technology, and African charity is not how one achieves a multi-billion valuation.
The VA is a big consumer of medical services.
It is interesting to look at their test menu at:
https://www.theranos.com/test-menu?ref=our_solution
You can see here that they have replicated most of the routine blood tests out there. Interestingly, they have also replicated some of the archaic and pretty useless blood tests like Rheumatoid Factor. They also offer Erythrocyte Sedimentation Rate (ESR). This is pertinent because ESR is actually a physical property of blood, it is performed by measuring the rate at which red blood cells fall to the bottom of a tube. Perhaps they have developed a microfluidic method to measure this, but it wouldn't be a 'chemical process'.
But at the end of the day, they are offering the same tests that are currently available. If someone said to me we can now do the same old blood tests faster and cheaper, I would say that this is going to have very little impact on people's health. None of these tests are truly useful in prevention or screening unselected patients.
It does really seem that Theranos is a case of packaging the existing blood diagnostics and trying to capture a large part of the market. Exciting for investors I guess, but for patients or healthcare workers probably not so much. I wish they were doing something like cheap, easy and reliable comprehensive circulating DNA analysis, or proteomics, or something with immune cell function profiling...
I hope with all this cash they have a program for giving this technology to places that can't afford the usual lab infrastructure, that would be a very good thing.
You can see here that they have replicated most of the routine blood tests out there. Interestingly, they have also replicated some of the archaic and pretty useless blood tests like Rheumatoid Factor. They also offer Erythrocyte Sedimentation Rate (ESR). This is pertinent because ESR is actually a physical property of blood, it is performed by measuring the rate at which red blood cells fall to the bottom of a tube. Perhaps they have developed a microfluidic method to measure this, but it wouldn't be a 'chemical process'.
But at the end of the day, they are offering the same tests that are currently available. If someone said to me we can now do the same old blood tests faster and cheaper, I would say that this is going to have very little impact on people's health. None of these tests are truly useful in prevention or screening unselected patients.
It does really seem that Theranos is a case of packaging the existing blood diagnostics and trying to capture a large part of the market. Exciting for investors I guess, but for patients or healthcare workers probably not so much. I wish they were doing something like cheap, easy and reliable comprehensive circulating DNA analysis, or proteomics, or something with immune cell function profiling...
I hope with all this cash they have a program for giving this technology to places that can't afford the usual lab infrastructure, that would be a very good thing.
> If someone said to me we can now do the same old blood tests faster and cheaper, I would say that this is going to have very little impact on people's health. None of these tests are truly useful in prevention or screening unselected patients.
Are you kidding? I'm not completely familiar here, but I'd love to see a comparison of the current SOC for time between measurements of each of these endpoints and then a clinical judgement that genuinely nothing interesting happens in these levels at timeframes shorter than SOC.
A person I'm familiar with has a severe endocrine disorder which has eliminated nearly all of his natural hormone production. Instead, he must self-administer all hormones in proper dosages. In order to survive this way he has become vastly more familiar with his own blood panel than most human beings ever would dare. On insurance dime he takes far more regular blood tests than you usually can get access to and understands, even very roughly, how events in his life, diet, exercise, stress, weather, etc begin to affect his blood chemistry and, subsequently, his life. In his, of course anecdotal, experience these are things that he cannot converse with doctors about because they're not able to speak confidently so far outside of SOC. It's not necessarily surprising stuff, but there's comparatively little real-world evidence to give it a bite.
Theranos could make similar analyses achievable for far more people. It opens an entirely new branch of clinical research---blood chemistry fluctuation at the level of perhaps up to multiple times per day over months at a reasonable cost in both testing and human time (given adequate distribution---Walgreens or, even, eventually, a home edition). You can't pretend that Phizer and GSK, known partners, aren't all about that.
> Exciting for investors I guess, but for patients or healthcare workers probably not so much.
Only if you assume SOC doesn't change under the influence of massively more available quantitative data.
Are you kidding? I'm not completely familiar here, but I'd love to see a comparison of the current SOC for time between measurements of each of these endpoints and then a clinical judgement that genuinely nothing interesting happens in these levels at timeframes shorter than SOC.
A person I'm familiar with has a severe endocrine disorder which has eliminated nearly all of his natural hormone production. Instead, he must self-administer all hormones in proper dosages. In order to survive this way he has become vastly more familiar with his own blood panel than most human beings ever would dare. On insurance dime he takes far more regular blood tests than you usually can get access to and understands, even very roughly, how events in his life, diet, exercise, stress, weather, etc begin to affect his blood chemistry and, subsequently, his life. In his, of course anecdotal, experience these are things that he cannot converse with doctors about because they're not able to speak confidently so far outside of SOC. It's not necessarily surprising stuff, but there's comparatively little real-world evidence to give it a bite.
Theranos could make similar analyses achievable for far more people. It opens an entirely new branch of clinical research---blood chemistry fluctuation at the level of perhaps up to multiple times per day over months at a reasonable cost in both testing and human time (given adequate distribution---Walgreens or, even, eventually, a home edition). You can't pretend that Phizer and GSK, known partners, aren't all about that.
> Exciting for investors I guess, but for patients or healthcare workers probably not so much.
Only if you assume SOC doesn't change under the influence of massively more available quantitative data.
I am assuming that SOC won't change under the influence of massively more available quantitative data, or at least any gains would be both slight and only applicable to a very small number of people. I think it is probably a misconception that humans are simple enough that measuring something (on Theranos' current testing panel) which is produced in ten different ways in five different organs from millions of cells and then diluted in 7 litres of blood is going to tell you anything revolutionary.
Certainly happy to be proven wrong, but there is a risk of harming people (financially, psychologically and perhaps medically) if you convince them that relentless tracking of their serum sodium tells them something useful.
Certainly happy to be proven wrong, but there is a risk of harming people (financially, psychologically and perhaps medically) if you convince them that relentless tracking of their serum sodium tells them something useful.
I think the difference here comes in use. I agree that misinforming people about the meaningfulness of their blood chemistry is dangerous and low value. My target users are not Quantified Selfers (although my anecdote example might have thrown that off) but instead large scale clinical research sponsors.
> A person I'm familiar with has a severe endocrine disorder
He said "unselected patients". The point is, some random guy with no preexisting condition might not actually benefit from being able to measure shit in his blood more easily. It could mostly lead to false positives, stress, and unnecessary costs. The only way to know for sure would be to do a study on it... but Theranos doesn't seem to like doing studies.
Making blood tests faster and cheaper would definitely be a good thing, but it's possibly not a completely transformative thing.
He said "unselected patients". The point is, some random guy with no preexisting condition might not actually benefit from being able to measure shit in his blood more easily. It could mostly lead to false positives, stress, and unnecessary costs. The only way to know for sure would be to do a study on it... but Theranos doesn't seem to like doing studies.
Making blood tests faster and cheaper would definitely be a good thing, but it's possibly not a completely transformative thing.
I am not claiming that any individual will receive personal benefit from their own use of Theranos, but instead that large scale clinical researchers will.
> If someone said to me we can now do the same old blood tests faster and cheaper, I would say that this is going to have very little impact on people's health.
I think you vastly under-estimate the impact of cheaper prices. We're not all sitting around with computers in our pockets because they're drastically different, we're sitting around with them because they're cheap.
Obviously there is skepticism on the applications, this is why she is giving all these talks about what this would enable.
I don't have any particular insight about what this kind of price drop will produce (though cheaper STD testing can't be a bad thing), but I think massive reductions in price do fundamentally change how things get done.
I think you vastly under-estimate the impact of cheaper prices. We're not all sitting around with computers in our pockets because they're drastically different, we're sitting around with them because they're cheap.
Obviously there is skepticism on the applications, this is why she is giving all these talks about what this would enable.
I don't have any particular insight about what this kind of price drop will produce (though cheaper STD testing can't be a bad thing), but I think massive reductions in price do fundamentally change how things get done.
I'm skeptical that there is anything massively different between the technology Theranos uses and that used by existing clinical diagnostic labs.
Their greatest claim, as least in the popular press, appears that they can do these tests on "a few drops of blood" (it appears to be about 0.5 ml from the image) as opposed to 10 ml or so. This claim is nothing special, as in fact almost all tests are eventually done on an aliquot no larger than a few microlitres that is withdrawn from the larger sample. As to speed of results, this would likely be linked to organizational efficiency rather than a technical innovation.
Further, there is no way all the tests shown on their website can be done with one 0.5 ml sample, as samples need to be collected into different anti-coagulants for different tests as some anticoagulants interfere with some tests but not other (this is why the doctor usually takes two or three samples into different tubes -- not because s/he needs 30 ml of blood).
They may however have improved automation, or a better run or cheaper service, in which case, good for them.
Their greatest claim, as least in the popular press, appears that they can do these tests on "a few drops of blood" (it appears to be about 0.5 ml from the image) as opposed to 10 ml or so. This claim is nothing special, as in fact almost all tests are eventually done on an aliquot no larger than a few microlitres that is withdrawn from the larger sample. As to speed of results, this would likely be linked to organizational efficiency rather than a technical innovation.
Further, there is no way all the tests shown on their website can be done with one 0.5 ml sample, as samples need to be collected into different anti-coagulants for different tests as some anticoagulants interfere with some tests but not other (this is why the doctor usually takes two or three samples into different tubes -- not because s/he needs 30 ml of blood).
They may however have improved automation, or a better run or cheaper service, in which case, good for them.
This gives a bit of perspective on their current system, it is far off something like a hand held scanner. It is from a blog article by a bio-chem due diligence company.
Whether it was due to the quantity of tests (7 tests) or the particular tests I ordered, I was quickly informed that I would be receiving a standard blood draw for my first visit. To my surprise, only 75-80% of patients receive the finger stick method, while the remaining 20-25% require a standard blood draw. The company’s goal to expand nationally relies upon the ability to integrate within the infrastructure of existing Walgreens’ drugstores, a feat made difficult by the need for a trained phlebotomist to serve a specific group of test orders. While the company currently offers more than 200 blood diagnostic tests, the internal assay development team is working to expand this menu to include over 1,000 of the most commonly ordered tests at their CLIA laboratory located in Palo Alto, CA.
In addition to my own blood draw, I stayed to observe the highly publicized finger stick, a staple of the start-up’s competitive appeal over established companies like LabCorp or Quest. It was here that the charm of Theranos became more obvious. Rather than a phlebotomist, a Walgreens pharmacy technician is easily able to perform the “nanotainer” blood collection steps, a testament to the simple and integrated workflow system developed by Theranos. Blood collection kits are provided to the technician, which include alcohol swabs, a warm compress, a finger stick, and a “nanotainer” (kept separately in a fridge). After scanning and labeling the sample tubes, the pharmacy tech begins the simple process as follows: apply warm compress to finger, clean the finger with alcohol swabs, massage blood towards the tip of the finger, stick the finger using one of 3 prick sizes (purple = small, pink = mid-size, blue = large), collect blood. The “nanotainer” which collects only a few drops of blood via capillary action, has continuously been an attractive marketing tool for Theranos, inflating the nano-sized tube with a larger than life persona. These samples are then stored in the fridge until a courier system can transport them to the CLIA certified lab in Palo Alto, where proprietary platforms allow the company to run traditional tests on 1/100th to 1/1000th of the ordinary volume. My results were emailed to my physician the following day.
http://decibio.com/blog/theranos-small-sample-big-opportunit...
Whether it was due to the quantity of tests (7 tests) or the particular tests I ordered, I was quickly informed that I would be receiving a standard blood draw for my first visit. To my surprise, only 75-80% of patients receive the finger stick method, while the remaining 20-25% require a standard blood draw. The company’s goal to expand nationally relies upon the ability to integrate within the infrastructure of existing Walgreens’ drugstores, a feat made difficult by the need for a trained phlebotomist to serve a specific group of test orders. While the company currently offers more than 200 blood diagnostic tests, the internal assay development team is working to expand this menu to include over 1,000 of the most commonly ordered tests at their CLIA laboratory located in Palo Alto, CA.
In addition to my own blood draw, I stayed to observe the highly publicized finger stick, a staple of the start-up’s competitive appeal over established companies like LabCorp or Quest. It was here that the charm of Theranos became more obvious. Rather than a phlebotomist, a Walgreens pharmacy technician is easily able to perform the “nanotainer” blood collection steps, a testament to the simple and integrated workflow system developed by Theranos. Blood collection kits are provided to the technician, which include alcohol swabs, a warm compress, a finger stick, and a “nanotainer” (kept separately in a fridge). After scanning and labeling the sample tubes, the pharmacy tech begins the simple process as follows: apply warm compress to finger, clean the finger with alcohol swabs, massage blood towards the tip of the finger, stick the finger using one of 3 prick sizes (purple = small, pink = mid-size, blue = large), collect blood. The “nanotainer” which collects only a few drops of blood via capillary action, has continuously been an attractive marketing tool for Theranos, inflating the nano-sized tube with a larger than life persona. These samples are then stored in the fridge until a courier system can transport them to the CLIA certified lab in Palo Alto, where proprietary platforms allow the company to run traditional tests on 1/100th to 1/1000th of the ordinary volume. My results were emailed to my physician the following day.
http://decibio.com/blog/theranos-small-sample-big-opportunit...
From that comment the key advantage appears to be the ability to collect blood without requiring a trained phlebotomist.
Let us not disregard the intelligence value the NSA or another other government entity gathers by doing a low resolution DNA sequencing all of the blood that goes through these machines for future reference. This covert use wouldn't be outside the bounds of proper skepticism with the involvement of ex-DoD members on the board.
Without proper auditing and disclosure of development processes and the new implementation of the diagnostic tests on chips (rather than disposable test media) it raises the question of how can anyone be sure exactly what and what not the machines are testing and recording? Slot machines in Las Vegas have their code more closely audited and monitored than this technology.
This situation just yells out for government regulation, peer review and reverse engineering.
Without proper auditing and disclosure of development processes and the new implementation of the diagnostic tests on chips (rather than disposable test media) it raises the question of how can anyone be sure exactly what and what not the machines are testing and recording? Slot machines in Las Vegas have their code more closely audited and monitored than this technology.
This situation just yells out for government regulation, peer review and reverse engineering.
Let me get this straight: because you're afraid that the NSA gets the hand on their data you want government regulation?
That's both the government.
When you're giving blood to some entity and you want to safeguard what happens to the result regulation won't get that for you, but independent oversight, sample anonimization at the source (insofar as this is possible with a blood sample, your DNA is your identity), decentralization of test locations (preferably as close to the source as possible), proven sample destruction and no keeping of data post sample destruction would be the way to go. Government oversight pretty much guarantees government access, the opposite of what you wish to achieve.
It will be very hard to create a service like this without a loophole that can be used to sneak such data out.
The best way in which this could be done is by having the tests made so foolproof that they can be done directly in the hospitals without centralized laboratories.
As for the board, you could say something similar about DropBox but I don't see them giving three letter agencies access to your account either without proper process and a court order.
Anything less could sink the company and given the amounts of money at stake here you can bet their competitors would love to do just that.
And who is to say that their competitors are not already acting in a similar manner anyway, they are after all processing about 100x more volume today.
That's both the government.
When you're giving blood to some entity and you want to safeguard what happens to the result regulation won't get that for you, but independent oversight, sample anonimization at the source (insofar as this is possible with a blood sample, your DNA is your identity), decentralization of test locations (preferably as close to the source as possible), proven sample destruction and no keeping of data post sample destruction would be the way to go. Government oversight pretty much guarantees government access, the opposite of what you wish to achieve.
It will be very hard to create a service like this without a loophole that can be used to sneak such data out.
The best way in which this could be done is by having the tests made so foolproof that they can be done directly in the hospitals without centralized laboratories.
As for the board, you could say something similar about DropBox but I don't see them giving three letter agencies access to your account either without proper process and a court order.
Anything less could sink the company and given the amounts of money at stake here you can bet their competitors would love to do just that.
And who is to say that their competitors are not already acting in a similar manner anyway, they are after all processing about 100x more volume today.
Microsoft, Google, Apple are all NSA PRISM program participants! And nothing happened to them. Why should that be different with Dropbox? And isn't Dropbox using Amazon to store its data. It would probably be sufficient, if Amazon participates.
>I don't see them giving three letter agencies access to your account either
And you wouldn't if they were served a NSL, which is very likely to have happened.
And you wouldn't if they were served a NSL, which is very likely to have happened.
This company being a front for something defense-related makes more sense than naive investors throwing money at an idea with nothing to back it up for more than 10 years.
After a bit of digging I found another article that discusses the skepticism a bit more. The comments are worth reading as well.
http://pathologyblawg.com/pathology-news/new-yorker-theranos...
http://pathologyblawg.com/pathology-news/new-yorker-theranos...
The article seems very confused - if the process is "patented", then surely the details aren't a secret? That's kinda the exact POINT of the patent system...
I don't understand. The article talks about how there is nearly no publicaly available proof that these tests actually work, yet they're selling them in drug stores and hospitals all over the country? And all we know is that supposedly "Theranos' labs have been evaluated and deemed acceptable by drug companies, hospitals that work with them, Walgreens, and others"? Why is this legal?
A little off-topic:
The famous Forbes-List estimates her wealth to be 4.5b, because she owns half of a company that has raised 200m. If she is somehow reasonable with the finances of her company, it is likely that her actual bank-account (or real-estate etc) is well below 10m - which is a hugh difference to all the old-money people far below her in the list.
The famous Forbes-List estimates her wealth to be 4.5b, because she owns half of a company that has raised 200m. If she is somehow reasonable with the finances of her company, it is likely that her actual bank-account (or real-estate etc) is well below 10m - which is a hugh difference to all the old-money people far below her in the list.
[deleted]
many scientific revolutions have occurred after improvement of measure instruments. If we start to have a continuous measure of our blood, there may be revolutionary discoveries about health.
ADR scanning could probably do this non invasively, it can even pick up prions in blood - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2008164/
Hey, can we test your blood? We are making blood tests more accessible. No, we won't tell you what we are doing with your blood or how we are doing it or even if it works. What do you mean how does this make blood tests more accessible? Look, don't worry, just trust us, after all we have Henry Kissinger on the board, so we must be on the level.
[deleted]
This title seems kinda weird. Can a mod make it more about the fact that the test method is in question rather than that someone got rich because they invented it?
What skills did she have that allowed her to do this, and where did she get the money to hire all the needed PhDs and get through FDA testing? How would she have even gotten access to the equipment and test subjects to prove that her idea was worth investing in outside of an academic setting? The whole thing sounds crazy.
Edit:
I read Elizabeth Holmes Wikipedia page and it says that when she was a sophomore at Stanford, her Chemical Engineering professor encouraged her to found the company. But I can't find anything about about any breakthroughs she made that warrant the millions in early investments. No one seems to want to talk about what exactly it is they're doing, and they're board of directors has a former Secretary of State, a former Secretary of Defense, and a former Senator. The fact that she's also been able to maintain 51% of this company is also astounding.