What a mess. This has nothing to do with Theranos's "nano" technology. This is about Theranos botching standard tests performed with standard commercial equipment, and then not reporting their errors.
Much medical lab practice includes running known test samples through the process regularly to check the test. They skipped a lot of that. Many things can potentially go wrong. They did. Expired reagents, freezers at wrong temperatures, failure to do regular maintenance, patient tests run on machines that were reporting errors... Some of the technicians hadn't completed medical technician training, but were doing complex tests. The summary: "Overall, over 21% of QC samples on all devices had values greater than 2 SDs". So many results were way off, and they weren't catching that.
Those are for standard tests on standard machines. The results for Theranos' "Edison" machine were worse. As in more than 10x more variation than standard techniques.
This isn't even the FDA. This is the Center for Medicare Services checking up on a company to which they paid a lot of money.
WSJ: "“This is the first time that we’ve actually seen data from the Theranos instrument, and it’s as bad as one would have worried it would be,” said Stephen Master, associate professor of pathology at Weill Cornell Medical College in New York. “Based on this data, it’s hard for me to believe that they went live with this instrument and tested patient specimens on it.”
"The inspection report said Theranos didn’t notify doctors treating patients potentially affected by the erroneous results until mid-November, or seven weeks after the inspectors first identified the problems."
"The lab directors during the period of the survey no longer hold any position within the lab. The new lab director..."
This looks like the "move fast and break things" crowd trying to run a medical lab.
> This looks like the "move fast and break things" crowd trying to run a medical lab.
No, I don't think that's fair to the "move fast" crowd. This looks more like a bunch of politically connected country club types trying to "brag" a startup. Eg: Board of Directors = Henry Kissinger, former Secretary of Defense Bill Perry, former Secretary of State George Shultz, etc.
These people are used to manipulating the system at the expense of the public and getting away with it. I presume they expected to be able to achieve the same with this as well.
Correct. Holmes is a figurehead being used by a group of "interested individuals", as I've been saying since Theranos started appearing in the news.
It may not have been blindingly obvious to most, but coming from a place where I am intimately familiar with the machinations of the plutarchy, this immediately struck me as a simple "let's screw with the market" type scam.
This makes double sense when you consider that between about 15 and 10 years ago when Theranos would have been brewing in the minds of the old boys club that run it, biotech was considered THE hot stock area among the overmonied class. They've cashed in, neatly.
Theranos is absolutely nothing special - apart from perhaps being a special interest entity.
The thing is, they won't have been setting out to create human suffering - it won't have even crossed their minds that that would be a side effect - they will just have been thinking about the market, and how to separate their less guileful chums from their cash. Theranos' medical negligence is "just collateral damage".
They nearly did. If it wasn’t for some relatively junior officer who insisted back in 2011 that Edison had to be run past the FDA first they would have got away with it. It was a close run thing and really a work of evil genius.
>If it wasn’t for some relatively junior officer who insisted back in 2011 that Edison had to be run past the FDA first they would have got away with it.
John the more I think about Theranos the more I think this “mess” is actually deliberate. Looking at the history of Theranos and the composition of the board it appears Theranos was designed from early on as a vehicle to defrauded the US military.
The plan appeared to be to use their connection and access to some rather “helpful” high brass to offload the technology for billions and then later sweep the fact that it didn’t work under the rug (this tactic has worked fabulously for the last 20 years). Avoid the FDA altogether.
Who would have noticed another $10 billion misspent on some wizz-bang technology given the $100s billions lost in other frauds? When the wheels fell of this plan (some underling didn’t play along) the idea seems to be to blame the scientists and say “we were misled”. They might be evil, but they don’t appear to be stupid.
Theranos must have pissed off someone very important, that lead to the initial WSJ article, and then to a reliable stream of revealing WSJ articles. I also think that this important person is in the military.
The downfall was a few years ago when the initial plan of just having the military buy Edison without it being run through a normal FDA testing program got blocked. If they had managed to avoid this they would have made out like bandits (well military contractors).
As for the WSJ there are a lot of waring parties trying to defraud military - the established big contractors don’t really want new competitors stepping on their turf.
Disagree, it is easy to find a Theranos article or Holmes quote with the word "disrupt". The enablers (VC's) of this trainwreck preferred that philosophy and not the traditional medtech/pharma/R&D that use Verify & Validate approach to development.
Hillary Clinton has used "disrupt" in her current campaign, and she almost sounded like she knew what she was talking about. Sort of like saying "source codes." You've heard of it, but it doesn't fit into your vocabulary quite right.
"Disrupt" seems to have emerged from tech and startups into political filler.
There should be special place in hell for Miss Holmes and her ilk.
Disrupting taxis (or dry cleaners or restaurants) is one thing. Gambling with peoples health and lives - intentionally or out of sheer incompetence - takes this to a whole different level.
I really hope (but don't necessarily believe) that the people responsible for this mess go to jail for their transgressions.
Much medical lab practice includes running known test samples through the process regularly to check the test.
One of my favorite answers to "what was your most memorable bug" starts with this process. We only discovered a major bug we had shipped years prior because a lab's twice-daily Quality Control check failed and they called us to report the problem. That kicked off a shitstorm...
That's what Henry Kissinger's job on the board is, presumably: preventing anyone being held accountable for deaths they cause. He has quite the track record at this.
There is an accompanying article [1] that gives more background. The part on there internal quality control tests show the tech just isn't there.
> The inspection report showed that 29% of the quality-control checks performed on the company’s proprietary blood-testing devices in October 2014 produced results outside the range considered acceptable by Theranos.
> In February 2015, an Edison-run test to measure a hormone that affects testosterone levels failed 87% of quality-control checks, the report said.
It doesn't look like they are using Edison to run most of their tests, so we can excuse the experimental tests if they aren't being used for actual patients. Chalk that up to work-in-progress.
What is absolutely inexcusable is their treatment of patients, especially when they found out that results were incorrect.
> Inspectors also found that Theranos sometimes released patients’ results even when the Edison devices used to run those tests produced erratic results in quality-control checks.
and
> The inspection report said Theranos didn’t notify doctors treating patients potentially affected by the erroneous results until mid-November, or seven weeks after the inspectors first identified the problems.
Seven weeks to notify customers that you may have fucked up a medical test? We reach out to customers about potential software bugs within an hour.
This is an instance where I am glad to have government slowing down innovation. "Move fast, break things" doesn't work when people's lives are at stake.
>"Move fast, break things" doesn't work when people's lives are at stake.
No matter what you do, people's lives are at stake. Even an app that suggests which restaurant to go for dinner could cause somebody to die by suggesting a restaurant in an area with higher rate of accidents.
The problem is how little consumers have control of when it comes to healthcare. We like to hand wave and pretend that the rules of economics don't apply when it comes to healthcare so instead of having a market where a person can shop for medicine, doctor's service, equipment etc. it all is more or less just close your eyes go in the tunnel and you will be taken care of and any issue of choice with regards to money is occluded by 'universal healthcare is a human right'.
If I could go to a hospital who would then give me a brochure of all the equipments they use and I find out one of their supplier is a dodgy companies that have dodgy equipments and terrible bug-handling practice I would go to another seller just as I would a smartphone that uses a dodgy processor that is known to break.
I'm going to go out on a limb and say that you fall a couple of sigma away from the typical customer for medical tests.
I would argue that most people, when they are already ill, do not want to have to perform life-or-death cost/benefit tradeoff analyses on highly technical accuracy data from the service provider who will perform their blood tests. They want to be assured that everyone in the market meets a basic standard of competency. We as a society have made a decision that we will pay more for our blood tests so that we don't have to do that homework for ourselves.
I do definitely think there is an opportunity for individuals to be better informed about the cost and quality of their health care, as long as it meets a basic standard.
As an analogy, the airline industry is able to be cutthroat-competitive on fares and routing, while still being highly regulated when it comes to safety. You can't choose to take a cheaper flight by agreeing to let the airline skip on oil changes.
Yes, ill people are a relatively captive audience.
This is a reason to force price transparency, not hand wave it away. Especially when the institutions in question have been granted exclusive local licenses for some equipment.
It would give people a chance to price shop when care isn't urgent. Lots of people would drive a couple of hours to take advantage of the hundreds of dollars of differences in prices for things like CT scans. This would normalize prices for people seeking urgent care! Of course, that would undermine the entire way we fund care in the US, but whatever.
I am all for price transparency in medical care. What I'm arguing is that there should be standardization of the quality of service that is being offered, so that customers are not put in the position of deciding how much measurement error they can afford to pay for.
You don't think there might be a certain information asymmetry between you and a medical care provider? And if there's not, why are you going to doctor at all?
Regulatory reasons. Even if there was pure info symmetry (a unicorn itself), I can't "prescribe" treatments for myself even to address well-known ailments, such as the case with anyone with a chronic disease or infection.
There is an information asymmetry when I buy an apple at the farmer market. That doesn't mean that every time I buy an apple I'm getting ripped off by the seller.
If you feel the value of your life/health is essentially comparable in gravity and scale to buying an apple at a farmer's market, your opinions on healthcare regulation are unlikely to be relevant to very many people.
Out of curiosity: has anyone ever tried to do a correlation about the performance of a hard-tech company vs the ratio of technical/political people in their board of directors?
This is probably a strong prior on my part - but when I saw the composition of the board of directors of Theranos (secretary of states/generals/congressmen etc) I was immediately incredibly skeptical. It seems like the board was chosen to provide lucrative contacts instead of actually useful advice and supervision.
This... this is real train wreck. When this finally goes down, it's going to happen so quickly, and I wouldn't be shocked if some people try to cut and run, fleeing the country.
This is one of those rare times where my procrastination in applying for a job at Theranos actually paid off. So grateful I avoided moving my family across the country to get entangled in this mess.
They're all dated November of 2015, which was right around when the WSJ investigation brought out. Is this the first time this document(s) was open publicly? What is the new information here?
"In April and May 2015, a test to measure prostate-specific antigen, or PSA, failed quality-control checks 22% of the time. The PSA test is used to help detect prostate cancer."
Ouch....
I see a string of class action suits in the future.
This is actually a lot worse than the results recently reported by Mount Sinai in their comparison of a few dozen patients against two standard lab testing companies. I wonder if Theranos has been trying to clean up their standard tests.
Doubtful, unless they've got any extant political enemies who want to make an example out of them. Theranos' BOD is basically a who's who of Washington power brokers.
It's a reporter with a juicy story. Just like with Woodward & Bernstein with Watergate, someone smells a Pulitzer coming if they can single-handedly trigger the collapse of a beloved unicorn.
That might be a little premature, but this team (primarily John Carreyrou and Christopher Weaver) are clearly not going to stop writing about Theranos any time soon. Additionally, they've pretty clearly provided an outlet for people who seem to be itching for this story to get some sunlight, so they're scooping the world on the blow-by-blow of Theranos' interactions with FDA, Walgreen's, Safeway, etc.
Much medical lab practice includes running known test samples through the process regularly to check the test. They skipped a lot of that. Many things can potentially go wrong. They did. Expired reagents, freezers at wrong temperatures, failure to do regular maintenance, patient tests run on machines that were reporting errors... Some of the technicians hadn't completed medical technician training, but were doing complex tests. The summary: "Overall, over 21% of QC samples on all devices had values greater than 2 SDs". So many results were way off, and they weren't catching that.
Those are for standard tests on standard machines. The results for Theranos' "Edison" machine were worse. As in more than 10x more variation than standard techniques.
This isn't even the FDA. This is the Center for Medicare Services checking up on a company to which they paid a lot of money.
WSJ: "“This is the first time that we’ve actually seen data from the Theranos instrument, and it’s as bad as one would have worried it would be,” said Stephen Master, associate professor of pathology at Weill Cornell Medical College in New York. “Based on this data, it’s hard for me to believe that they went live with this instrument and tested patient specimens on it.”
"The inspection report said Theranos didn’t notify doctors treating patients potentially affected by the erroneous results until mid-November, or seven weeks after the inspectors first identified the problems."
"The lab directors during the period of the survey no longer hold any position within the lab. The new lab director..."
This looks like the "move fast and break things" crowd trying to run a medical lab.