Theranos closes last blood-testing lab after reportedly failing an inspection(techcrunch.com)
techcrunch.com
Theranos closes last blood-testing lab after reportedly failing an inspection
https://techcrunch.com/2017/01/17/theranos-last-lab-inspection-test-fail/?ncid=rss&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Techcrunch+%28TechCrunch%29&utm_content=FaceBook&sr_share=facebook
61 comments
A comment by user DarthSlack at Ars Technica was a bit chilling it said "Just think. Under a Trump FDA, Theranos probably would be highly successful."
What about a Trump FDA would make Theranos successful? Also, we really cant escape a political discussion anywhere can we?
If the director of the FDA is anti-regulation, pro-drug companies/ in their pockets etc. they would not investigate charges of fraud which would lead to continuance of the fraud.
The incoming administration doesn't even need to push through radical new laws/regulation. All it needs to do is to choose not to enforce them, or delay it indefinitely (well at least until the end of their term).
The incoming administration doesn't even need to push through radical new laws/regulation. All it needs to do is to choose not to enforce them, or delay it indefinitely (well at least until the end of their term).
I didn't vote for the incoming President-Elect, but even I feel this statement is a bit far reached.
Right, but that wouldn't change the fact that Theranos' product doesn't work. Their customers would find that out pretty quickly regardless of whether or not a regulator got involved. Were current federal regulators behind that discovery?
The whole point of regulations to protect consumers is to protect them from spending their money on things that don't work.
I know it's a bad idea to engage on this topic on HackerNews but...did you see Trump's press conference in which he says that we need to negotiate drug prices and do something about drug companies going to other countries for tax purposes? Have you seen the stories today about drug and biotech stocks "tanking" as a result?
Lets just say its hard to take anything that Trump says seriously, seeing how many times he flip flops on even the most basic issues.
Mattis' influence, perhaps.
That makes no sense at all. Their technology didn't work. How could they be successful even if the FDA disappeared?
This is a classic democratic/liberal fallacy, perhaps the free market would take care of Theranos (like it should) when their customers find out the product is faulty and not some regulator parading in on a white horse like he's the savior of mankind.
I had no idea they hadn't already shut down.
How likely is that Holmes goes to jail?
IANAL but it probably depends on how much she was personally aware of what they were doing was fraudulent. Which does seem to be the case....
Can somebody provide tl;dr of what was wrong with their tests and how come they got this far if the tests were flat out wrong? Did they just used low precision tests and pass them as high precision or some such?
I don’t think anyone from Theranos has come out and said anything definitive publicly.
The main criticism from outsiders all along has been that blood drawn from a pin-prick just has too much variability for reliable blood testing. Which in turn means that Theranos’ approach to blood testing was never going to work for anything quantitative - it might be OK for 'is this chemical present or not' but not for anything else.
They spent a long time using traditional blood tests alongside their pin-prick versions (this is the service they were selling to Walgreens(?) - presumably they used their investor cash to subsidise the service & undercut their more traditional competitors) whilst trying to get the pin-prick to work but they couldn’t even manage to do those correctly.
How they managed to get this far is a question of hubris and investor gullibility. There’s also the possibility of outright fraud, but we don’t know if that was the case at this point.
The main criticism from outsiders all along has been that blood drawn from a pin-prick just has too much variability for reliable blood testing. Which in turn means that Theranos’ approach to blood testing was never going to work for anything quantitative - it might be OK for 'is this chemical present or not' but not for anything else.
They spent a long time using traditional blood tests alongside their pin-prick versions (this is the service they were selling to Walgreens(?) - presumably they used their investor cash to subsidise the service & undercut their more traditional competitors) whilst trying to get the pin-prick to work but they couldn’t even manage to do those correctly.
How they managed to get this far is a question of hubris and investor gullibility. There’s also the possibility of outright fraud, but we don’t know if that was the case at this point.
"The main criticism from outsiders all along has been that blood drawn from a pin-prick just has too much variability for reliable blood testing."
If this is the case, why the hell are we using it for blood sugar level testing in diabetic patients?
If this is the case, why the hell are we using it for blood sugar level testing in diabetic patients?
The issue is not that it can't be used for anything, but that what you use it for depends on how much of whatever you're looking for will be present in any given volume of blood.
Sugar is present in sufficient quantities that the variation you get from one pinprick to another isn't going to be a big deal.
Many other things will be present in small enough concentrations that even if it is present in your blood you might not have sufficient quantities for it to be detectable in blood from a single pin-prick.
Sugar is present in sufficient quantities that the variation you get from one pinprick to another isn't going to be a big deal.
Many other things will be present in small enough concentrations that even if it is present in your blood you might not have sufficient quantities for it to be detectable in blood from a single pin-prick.
Going back to the white blood cell count. The gold standard is flow cytometry. If there is an interferent in the sample, or if the cytometer raises any flag, in some labs the backup plan is to do a manual count (100 cells) using whitefield microscopy ... are you really concerned about sampling problems?
I don't see how what you're saying relates to what I wrote.
>If this is the case, why the hell are we using it for blood sugar level testing in diabetic patients?
Because it obviously works for sugar level testing, but not for the kind of tests Theranos claimed to do?
Because it obviously works for sugar level testing, but not for the kind of tests Theranos claimed to do?
Consider that a glucose molecule is maybe 1.5nm in size, while a red blood cell is 6-8µm and a white blood cell is 12-15µm. Then consider that a capillary is 5-10µm in diameter. The cells actually deform to be able to fit through.
Apart from what the other answer says, notice that diabetics get a pinprick every single day and that only exaggerated values (either low or high) are relevant. And then again, it is a very easy and simple procedure, for glucose, you do not need any fancy laboratory for this single test.
I'm sorry but this is incorrect for a lot of blood tests. When the theranos debacle unfolded there was a paper making the rounds (no doubt leveraging on the media's attention)that argued this point for white blood cell counting. The conclusions were overblown, there is increased variability when using small amounts of capillary blood, but the tests are still useful. Furthermore, a lot of parameters are less sensitive to this heterogeneous distribution of the analyte.
Case in point. Major companies like roche and abaxis have had point-of-care medical devices that perform blood testing for various parameters that use a drop of blood.
Theranos's problem was that they said they could do pretty much every parameter under the sun, and they used an FDA loophole to operate their lab. It was later discovered that 90% of the tests were not being processed with their supposed technology.
Case in point. Major companies like roche and abaxis have had point-of-care medical devices that perform blood testing for various parameters that use a drop of blood.
Theranos's problem was that they said they could do pretty much every parameter under the sun, and they used an FDA loophole to operate their lab. It was later discovered that 90% of the tests were not being processed with their supposed technology.
M.D. here, one of the biggest red flags was that some patients had warfarin dosing adjusted based on these tests. As a blood thinner, warfarin requires close monitoring and accurate INR measurements to keep patients from bleeding to death.
I'd love to have more insight into how this happened.
It seems like there's a pattern of high profile failures of highly funded science-based startups.
From the outside the science seems faulty from the start, the management team seems to have no strong scientific background.
Do investors really fund purely based on their force of personality? Personal connections? Do they see a big market and then ignore the scientific DD?
I'd love to understand this better.
It seems like there's a pattern of high profile failures of highly funded science-based startups.
From the outside the science seems faulty from the start, the management team seems to have no strong scientific background.
Do investors really fund purely based on their force of personality? Personal connections? Do they see a big market and then ignore the scientific DD?
I'd love to understand this better.
> Personal connections?
In the case of Theranos I believe it was this. Elizabeth Holmes seemed to have an "in" with a lot of Washington D.C. influencers and I'm pretty sure her pitch was based on using those connections to score lucrative DoD contracts.
In the case of Theranos I believe it was this. Elizabeth Holmes seemed to have an "in" with a lot of Washington D.C. influencers and I'm pretty sure her pitch was based on using those connections to score lucrative DoD contracts.
>Elizabeth Holmes seemed to have an "in" with a lot of Washington D.C. influencers
her father has that "in". USAID is sometimes a cover for CIA, and the "network effect" here has been extremely high.
her father has that "in". USAID is sometimes a cover for CIA, and the "network effect" here has been extremely high.
The fact that her father is tied to USAID makes a lot of sense. USAID is the soft power arm of the federal government. It exists mainly to bribe foreign leaders to gain desired policy outcomes in their countries. It does do some good things when those align with politics.
If you needed to find government patrons willing to invest in a corrupt organization and engender goodwill at the same time, USAID is not a bad choice.
If you needed to find government patrons willing to invest in a corrupt organization and engender goodwill at the same time, USAID is not a bad choice.
I think this is availability bias. Many large (> $100M) deals happen all the time in early stage life sciences but don't get picked up by the tech press or covered as "startups". A few high profile stories flame out spectacularly like this but they are typically already the outsiders to the industry.
To the specific scenario, when N is small all kinds of idiosyncratic bad decision making can happen.
To the specific scenario, when N is small all kinds of idiosyncratic bad decision making can happen.
Hmm.. this is significantly more than 100MUSD (630MUSD).
I'd love some examples of good plays in this area (that is, those that resulted not just in acquisition but viable products). This area being life science tools/diagnostics.
From the companies I've been it seems to be biased toward crazy plays that had a stack of money thrown at them. Honestly would like to hear about others, know where to read about others.
I'd love some examples of good plays in this area (that is, those that resulted not just in acquisition but viable products). This area being life science tools/diagnostics.
From the companies I've been it seems to be biased toward crazy plays that had a stack of money thrown at them. Honestly would like to hear about others, know where to read about others.
I've been fortunate enough to work at two so far.
At Aperio I was on the team that designed a digital pathology instrument. At the time this was pretty new tech. We were purchased by Leica a little more than four years ago.
After that I went to epic sciences. We will be releasing our first LDT this year in a partnership with Genomic Health. It's a blood based prostate cancer test with demonstrated clinical utility, the first of its kind in the CTC space as far as I'm aware.
At Aperio I was on the team that designed a digital pathology instrument. At the time this was pretty new tech. We were purchased by Leica a little more than four years ago.
After that I went to epic sciences. We will be releasing our first LDT this year in a partnership with Genomic Health. It's a blood based prostate cancer test with demonstrated clinical utility, the first of its kind in the CTC space as far as I'm aware.
It seems that if you have a 100% working technology, you are better off filing for patents and licensing the tech to a large incumbent.
The need for venture financing arises when you're anywhere below 100% reliability, and are temporarily in this "fake it 'til you make it" category where the company has to rely on regular doses of cash infusions without much to show for (potentially) years. The problem with that approach is that for some the "make it" never quite materializes.
The need for venture financing arises when you're anywhere below 100% reliability, and are temporarily in this "fake it 'til you make it" category where the company has to rely on regular doses of cash infusions without much to show for (potentially) years. The problem with that approach is that for some the "make it" never quite materializes.
I think it'd be cool to get a bunch of statisticians together to review Optimizely. Print out pages of the UI, remove the logo, and then ask them to write down opinions on the validity of the results UI they're shown.
Please, please, please do so!
https://news.ycombinator.com/item?id=10873226
https://news.ycombinator.com/item?id=10873226
The problem is that it's a lot of work and there's really no incentive to do so. At the end I worry the group could be retaliated against and/or be considered complainers. There really isn't any benefit to doing a review like this that I could see. Plus if you're a statistician like me, you already know the conclusion, a kind of blind study would only build credibility for non-statisticians. :-/
UBeam is another one of these faulty science startup that should fail soon.
>> the management team seems to have no strong scientific background.
When your CEO founded a company after only a semester of a Chemical Engineering program, there should be red flags everywhere.
When your CEO founded a company after only a semester of a Chemical Engineering program, there should be red flags everywhere.
Half the founders in Silicon Valley, including many of the most revered ones, are college dropouts.
Therein is part of the issue: Silicon Valley is built on software, and software development is very different from medicine. Not trying to say one is harder or easier, but one is a much more unconstrained space of creation in which a really good, revolutionary idea and a strong mission can create a company, and in the other... a broad vision might simply be impossible. "We're going to build a social network online where people can post and see their friends' posts" is a nice vision that can be implemented in code; "We're going to diagnose lots of diseases based on a single pinprick worth of blood" is a nice vision that you can't actually do.
I think their is in incongruence to medical development cycles and software development cycles that will keep most tech money from investing too reliably.
On the other hand, the Boston and San Diego medchem startups are founded by established scientists in their 40s. Computers are quite the anomaly in the space.
The infrastructure requirements are a lot lower in tech. It's possible to be a college dropout and already have many years and projects worth of experience under your belt. It's pretty damn hard to do bio and chem without a proper lab.
The vast majority I have run across have more traditional educational backgrounds, many with advanced degrees through the PhD. It's just not as fun for journalists to profile the 37 year old PhD as the 19 year old dropout.
You're right of course. I should have said half the founders that get mentioned on sites like this one and TC.
Except they're building websites and mobile apps, not complex scientific instruments.
Yeah that matters a lot less when you're building web services. We're talking science here, not learning the latest web framework.
But most of those startups don't need a scientific background to form.
>I'd love to have more insight into how this happened
There's the one story that you can read in articles like this, which will provide details of the rise and fall:
http://www.vanityfair.com/news/2016/09/elizabeth-holmes-ther...
But, there's another side: it happened because you weren't allowed to question Elizabeth Holmes. The beauty of the Internet is its natural history keeping. If you want more insight into how this sort of thing happens, look no further than early discussions about Theranos on these very boards. It was difficult to be critical, and supporters implied that the naysayers were merely "sexist". Of course, this was happening when tech industry sexism was peaking in the news cycle, and I belive that quieted some criticism.
There's the one story that you can read in articles like this, which will provide details of the rise and fall:
http://www.vanityfair.com/news/2016/09/elizabeth-holmes-ther...
But, there's another side: it happened because you weren't allowed to question Elizabeth Holmes. The beauty of the Internet is its natural history keeping. If you want more insight into how this sort of thing happens, look no further than early discussions about Theranos on these very boards. It was difficult to be critical, and supporters implied that the naysayers were merely "sexist". Of course, this was happening when tech industry sexism was peaking in the news cycle, and I belive that quieted some criticism.
If you want more insight into how this sort of thing happens, look no further than early discussions about Theranos on these very boards. It was difficult to be critical, and supporters implied that the naysayers were merely "sexist".
Where?
Story from two years ago, before it blew up: https://news.ycombinator.com/item?id=9440595 - Lots of criticism, some even calling it a scam, yet no mention of sexism nor heavy downvotes.
The original submission: https://news.ycombinator.com/item?id=6349349 - Some criticism, not downvoted nor called sexism.
Tell me, where are all those comments warning us about the impending doom at Theranos and getting silenced by supporters calling them sexist?
Where?
Story from two years ago, before it blew up: https://news.ycombinator.com/item?id=9440595 - Lots of criticism, some even calling it a scam, yet no mention of sexism nor heavy downvotes.
The original submission: https://news.ycombinator.com/item?id=6349349 - Some criticism, not downvoted nor called sexism.
Tell me, where are all those comments warning us about the impending doom at Theranos and getting silenced by supporters calling them sexist?
>Tell me, where are all those comments warning us about the impending doom at Theranos and getting silenced by supporters calling them sexist?
There have been nearly 500 Theranos articles posted here over the years. You conclude it didn't happen after looking at two?
As someone who participated in the conversation, I know it happened. I'm not overly concerned with combing through the articles to convince you. The OP asked "how this happens"; if you don't think "girl power" at a time when sexism in tech was all over the place was one of the factors that led to an unqualified 20-something overseeing a potential giant fraud, I'm not sure what to tell you.
There have been nearly 500 Theranos articles posted here over the years. You conclude it didn't happen after looking at two?
As someone who participated in the conversation, I know it happened. I'm not overly concerned with combing through the articles to convince you. The OP asked "how this happens"; if you don't think "girl power" at a time when sexism in tech was all over the place was one of the factors that led to an unqualified 20-something overseeing a potential giant fraud, I'm not sure what to tell you.
I'm sure you can find some examples then
I'm sure I could, as much as I'm sure I won't be bothered to.
> There have been nearly 500 Theranos articles posted here over the years. You conclude it didn't happen after looking at two?
I looked at the two I could find with comments from before the whole thing blew up. The vast majority of posts about Theranos are post-blowout, from the past year and half, not those early discussions you were referring to.
> if you don't think "girl power" at a time when sexism in tech was all over the place was one of the factors that led to an unqualified 20-something overseeing a potential giant fraud, I'm not sure what to tell you.
I find your restatement of the previous claims inaccurate. You said "It was difficult to be critical, and supporters implied that the naysayers were merely "sexist"", which is much more specific that her gender having been a factor in story. Yes, it might have. Not in the way you portrayed it, though, in my opinion, at least not in HN.
I looked at the two I could find with comments from before the whole thing blew up. The vast majority of posts about Theranos are post-blowout, from the past year and half, not those early discussions you were referring to.
> if you don't think "girl power" at a time when sexism in tech was all over the place was one of the factors that led to an unqualified 20-something overseeing a potential giant fraud, I'm not sure what to tell you.
I find your restatement of the previous claims inaccurate. You said "It was difficult to be critical, and supporters implied that the naysayers were merely "sexist"", which is much more specific that her gender having been a factor in story. Yes, it might have. Not in the way you portrayed it, though, in my opinion, at least not in HN.
This is the article I read to learn what had went on last year and it is quite thorough. I'm looking forward to the movie mentioned in the article, seriously, I think it will be fascinating. There are scam companies and people embellishing the truth all over the place but they are usually found out fairly quickly, the fact that Theranos received so much investment and entry into various speaking engagements and clubs is what makes this so interesting. I wonder if it had not been medicine related and putting peoples lives in danger whether the show may have continued for longer.
Has anyone met Elizabeth Holmes? What is her leadership style?
Glassdoor can provide lots of information on questions like this. From the reviews, it would seem that her style is a classic authoritarian/machiavellian. You're in her group or you're out, and if you're out she'll pit you against other people instead of dealing with you directly. The whistleblower former employee who started the ball rolling on disclosing many of their issues has a fascinating account of what it's like to deal with her.
http://www.wsj.com/articles/theranos-whistleblower-shook-the...
http://www.wsj.com/articles/theranos-whistleblower-shook-the...
Paywalled
While I don't like to see people lose their jobs or companies close up, I feel like the company looks at safety as a roadblock to them being called geniuses and making money rather than part of their processes. Usually problems like this stem from senior management and is likely to not change unless someone else takes over entirely.