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US Regulators Find Serious Deficiencies At Theranos Lab (wsj.com)
An anonymous reader writes: 2016 has not started well for blood-testing startup Theranos. Already facing allegations of data manipulation, the Centers for Medicare and Medicaid Services have found problems with Theranos' laboratory in Newark, California, putting the company's relationship with the Medicare program in danger. WSJ reports: "It isn't clear exactly what regulators have faulted Theranos for in their latest inspection, which took several months. Adverse findings would be another regulatory setback for one of Silicon Valley's highest-profile startups, valued at about $9 billion in 2014. Theranos already has stopped collecting tiny samples of blood from patients' fingers for all but one of its tests while it waits for the Food and Drug Administration to review the company's applications for wider use of the proprietary vials called 'nanotainers.' In October, the FDA said it had determined that the nanotainers were an 'uncleared medical device.'"
So, going from a revolutionary plan to do tests with markedly less blood using your super-neat proprietary hardware to not even being able to operate off-the-shelf hardware from competitors well enough to satisfy Medicare?
I guess we can't all be disrupters...
Sure, because nobody every put a medical device on the market that failed due to an unexpected task case, and/or were unable to produce documentation demonstrating that they did or did not have adequate test coverage
Theranos has been making extraordinary claims and providing no proof (to the public, anyway).
To me it seems like they continue to not quite live up to the hype. They have really interesting stuff that doesn't seem to be quite there yet. For medical testing I personally want them to be very rigorous making sure it works as accurately as what we have now. For non medical 'for funz' or 'other' testing I would be less concerned. I definitely want them to succeed as it would be a boon to the world, but it needs to be rock solid, not the 'mostly works' SV startup type stuff.
Yes, I am sure the laws of nature are conspiracy aimed at forcing big government on us and stifling or tech savvy dreams of flying out of the window by flapping our ears.
I'd like to think this is true, but are there any patents to back up their tech?
How do they manage to get by with less material than is generally required, and have they been able to show (through data reproduction) that their techniques get the same results with less?
Why do you say they are technically savvy? Their marketing appears to be savvy, but all the impartial stories I've seen (including from Reason, which is usually against regulators and incumbents who benefit from regulations) give the impression of dodgy technology at Theranos.
Here come the fans of personal responsibility, blaming their failures on others...
Theranos has made unsubstantiated claims from day one, and tried everything they can think of to bypass the process every other medical device manufacturer follows.
gone wrong.
I've read that they have at least one patent. They do not seem to be doing very well on the "reduction to practice" bit that is supposed to be a prerequisite for getting a patent, though.
A capillary blood collection tube is Class I and not subject to pre-market approval (21 CFR 864.6150). But for some reason the Theranos capillary nanotube is class II? Why?
FYI: Theranos has quite a controversial background of articles here at Slashdot:
In October, they were called "vaporware."
In November, they were "disruptive."
In December, they had alleged data manipulation.
The real story here is not about some medical device or a failed test.
The story, and reason we take pleasure in this downfall is because a charismatic, supposed prodigy, Stanford-privileged, everyone-wants-to-believe-in-successful-woman CEO, who was able to convince funders based on flashy visions and compelling talk, has been found out to have nothing behind the emperor's clothes. And that so many people who are purportedly expert at evaluating technology got collectively duped/brainwashed into believing a whole bunch of fluff based on no more than a TED talk-level technology pitch.
While others who are working on real demonstrable technology, and do not get the benefit of celebrity status, Silicon Valley connections, get passed over for grants / VC money / recognition because they're not connected or privileged in the same way.
Stop believing so much in the vision and hype. Ask for and act on real results more.
How do they manage to get by with less material than is generally required, and have they been able to show (through data reproduction) that their techniques get the same results with less?
So far as I know, they haven't let any independent labs near their technology. To me, an ex-med tech, that is extremely suspicious. If the technology is sound, they should be bragging about it, taking it to trade fairs and letting large hospitals test it out.
Shouldn't they have hundreds to thousands of patents if they're actually doing what they're saying?
There are two types of people in the world: Those who crave closure
Even worse, a recent article indicated they had effectively stopped using their own process for testing and had gone back to using the previous method.
If anything screams scam, that should be a flashing red light.
We will bankrupt ourselves in the vain search for absolute security. -- Dwight D. Eisenhower
Theranos device has integrated testing capability and the capillary tube contains the sample while it is delivered to a desperate testing device, which in all likelihood is a medical device
Actually, we're not. I'm pretty high up in finance in the California division of the largest testing company. I don't speak for my company so I'm posting as AC.
It's an interesting situation. We're taking a wait-and-see approach to what Theranos is doing. This is a very highly regulated business, and Theranos' approach was backwards-- they set up their business associations before getting the necessary governmental and regulatory approvals. Start-up style, if you will. And it's coming back to bite them now.
That's not to say that we won't adopt some of their approaches if it works out. From a business perspective, their plan for consumer-driven testing is an fascinating one. They are targeting the healthcare consumer rather than the physician, which turns the testing world on its head. Unfortunately, that's a lot harder in California than it is in most other states, though.
The medical testing field is weird that way. The physician, who is the only one who can order most testing, is our customer. So are the insurance companies, and the government, in their role as Medicare/MediCaid administrators. The patient, who supplies the sample and usually pays part of the bill, currently has little or no say about what company actually does the testing. Theranos plans to turn that sideways, which is a very interesting approach. I hope it works out because we'll all benefit. I'd probably be executed for saying so, but if our company has to give up a little so that the patients benefit, I don't have a problem with that.
Thousands seems high. I could see dozens, and maybe hundreds in the US's patent-happy system. I don't know how many they have, beyond one that I saw attributed to their CEO's time in grad school. They might have dozens or hundreds (especially if you include filed but not granted).
"Are you so sure? Does it not make some sense that advancements could be made on how much you need to collect?"
On this point, yes, we're pretty sure.
Here's the problem: when there's something bad (bacteria, virus, mutated DNA) in your system, it usually appears in very small copy numbers (copy number is a technical term that tells you how many copies of something you see in a given sample). The relative abundance (another commonly used term that tells you how common your target is compared to everything else in the sample) of the bad stuff (not a technical term) is usually very small compared to the good stuff. So much so, that often times you need a large sample just to get a single copy of a bad thing. In most biological systems, we're talking needle-in-a-haystack small copy numbers for bad things.
Think of it this way: Let's say you have a gallon bucket full of coins with only a few quarters. You randomly sample a cup of coins. Can you confidently say there are no quarters in the bucket? Now say the coins are flowing through a series of tubes (no, these are not bitcoins on the internet) and your sample is determined by the coins present when you siphon off your cup's worth. What would the relative abundance need to be before you can confidently say quarters are present in the system using a cup for sampling? How about using a quart for sampling?
Somewhat like the laws of thermodynamics limit the ability to create perpetual motion machines, relative abundance/copy number place hard limits on the sample sizes needed to detect things in blood with confidence.
-Chris
Are you really advocating a system where patients regularly give multiple samples and send them to multiple labs just to check to see if the lab isn't cutting corners at the risk of killing them? We have a regulatory agency to prevent that sort of thing (rather than waiting until after the bodies stack up). In this case it's called the FDA.
Except that the FDA is doing much much more than that. If the FDA merely had a certification program that allowed patients to know which labs were more likely to give accurate results - then that would be very useful.
But the FDA is not allowing people to choose: it is forcing them to only use certified labs. And there are compelling reasons to suspect that the certification process is less about insuring accurate results and more about protecting existing monopolies (e.g. forcing people to pay medical doctors as an unnecessary middleman for the tests rather than getting the tests directly).
Knowledge is power and I accept that the government has a role in preventing deliberate fraud. But Americans should also believe in freedom: Live free or die, as they say. So we should remain vigilant and suspicious of the motives of government agency that aggressively restricts our freedom.
Single cell sequencing isn't useful as a diagnostic technique for the same reason I outlined above: every cell has a slightly different genome sequence.
When you're sequencing for diagnostics, you need a consensus genome for the tissue or tumor, not the genome for individual cell in the tissue or tumor. That's because not every cell in the tumor will necessarily have the variation that led to the tumors and it's possible for a single tumor cell to be in the healthy tissue. It's only over populations of cells that the negative effects can be measured properly.
If you're measure gene expression instead of DNA variants (e.g., looking for gene fusions), the problem is even worse. Not only do you need to sample many cells, but some of those cells need to be actively expressing the damaged gene to be able to sequencing it.
Disclaimer: I helped develop a single cell sequencing product and currently run a gene sequencing software company. I'm also friends with people at the FDA. I can assure you, they're not protecting profits for anyone and have the best interests of the patients in mind. It might look like bureaucratic overreach at times, but their goal is for only safe products enter the marketplace.
That goes for interpretation, too, which is why 23andMe got smacked down so hard. The science connecting genotypes to phenotypes is not as strong as the popular press would have you believe (there's currently a reproducibility crisis in the whole genome association study (WGAS) community, where most of the disease/gene associations come from). Sure, you can go to pub med and read all the studies, but understanding the body of knowledge to place those studies in context is difficult even for professionals.
-Chris
And by WGAS, I meant GWAS (genome-wide association study). Post-workday brain kicking in...
-Chris
23 and Me was warned that their changes in advertising were pushing the limits, and they changed them again to push the limits further.
What specific claims were they making that were so objectionable that you think it was necessary to take away their freedom of speech? Do you imagine that the American public is so stupid that they can't tell the difference between a website and a medical doctor?
Then the government said "Okay, back up what you're saying." Which was met with silence.
The variant calls that 23andMe was providing were from a CLIA-certified lab. So the underlying data was as good as what you would get from a test ordered through a medical doctor.
The question was the interpretation. And the FDA made the assumption that any interpretation made by a random medical doctor, even without any specialized training in genetics, was 100% correct while the FDA also required 23andMe to provide separate studies for each variant - even when such studies already existed in the scientific literature.
Basically the FDA had a ridiculous double standard where medical doctors were allowed to spout whatever nonsense they wanted while 23andMe were saddled with a burden of proof that was absolute nonsense.
They reason that individuals really can't assess the validity of these claims on their own, and in too many cases will act irrationally given some information.
OK, so if we're going to protect people from bad information, how about we start by banning religion?
It's calling "Fire" in a crowded theater when there isn't one.
It's perfectly legal to shout "Fire!" in a crowded theater is you genuinely believe that there is a fire. In fact, most people would say that there is an ethical, and perhaps even legal obligation, to do so. The interpretations that 23andMe was providing were state of the art - based on the consensus of the latest scientific research. But the FDA came along and said, "Sorry, unless you spend billions of dollars and many years verifying that there is, in fact, a fire in this theater you are not allowed to express that opinion."
It wasn't just that the FDA said, "OK, we happen to disagree with your interpretation and have provided out own." The FDA didn't allow 23andMe to provide their interpretations at all.
There's plenty of innovation in diagnostics going on out there.
Medical/personal genome sequencing is one of the biggest innovations in the history of medicine. If you're not aware of the massive stifling effect that the FDA has had on innovation in this area then you are just almost incomprehensibly ignorant. Many thousands, perhaps even millions, of people are dying because the FDA is focused on protecting certain monopolies in the healthcare sector - at the expense of patients and freedom.
I'm not advocated for that. I'm saying people will do that anyway, and if results are inconclusive they will let people know.
People are just like that in case you hadn't yet figured it out.
"There is more worth loving than we have strength to love." - Brian Jay Stanley
How many times will investors be fooled by people like this. When I see a company that has a "superstar" on the front page of everything, giving talks, giving interviews, always in the "top 40 under 40" I just know that this is someone who is not minding the store. If you look at companies that were massive successes in their start such as Google, Facebook, Microsoft. These were companies where the top people largely stayed out of the spotlight. Later after the companies had massive and real products the leaders might spend more time on something else. A full time self promotion tour has only one real goal, self promotion. Actually working on a product of this nature takes huge amounts of effort in the lab, and then huge amounts of effort in the regulatory department. There is no time left for strutting and preening. This is what marketing departments are for.
/., reddit, local newspapers, international news, everywhere at once. Again this only happens when the product is something for everyone (erection drugs) or has a massive promotion campaign behind it. Except that, again, this product only needs to be promoted to labs, and it pretty much will sell itself if it works.
The other reality is that a product like this can pretty much sell itself. But my first indication of the product being crap was that I was suddenly seeing it mentioned everywhere. Here on
Thus all that promotion was aimed at investors. She was aimed at investors. This entire exercise was a combination of promoting her, and getting investor money into her pocket. Full stop. The science would pretty much have gotten in the way. Plus I can see someone like her actually resenting a star scientist who might actually end up with credit. I suspect that the scientists working for her were glorified coffee boys and pencil sharpeners.
You'll notice that the 'government goons' are not doing anything to or against Theranos' R&D arm. They haven't actually made their system work for much yet; but they are free to continue poking at it until they can no longer find the money to do so.
The current inquiries are into Theranos' lab services arm, which is already up and running and (mostly not using their own process to do so) offering various blood tests. For the process that they are researching, efficacy is between them and their investors. For the process that they are already selling, 'wait and see' time is over and we are seeing if they have made the process that they are selling work before selling it.
You're posting as an AC, so it's not really worth responding, but...
Please give me some citations to support your claims that millions are dying due to the FDA holding back innovative treatments.
While you're at it, give me some citations that show that the average American can properly interpret the result of self-prescribed tests and make sound medical decisions on their own without the advice of experts.
For the first, cancer is the genomic disease that kills the most people. There are roughly 600k cancer deaths per year in the US (http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044509.pdf) While it's a high number, it's hardly millions (there are about 1.6M new cancer diagnoses per year). And there just aren't any good blanket approaches on the horizon that will make a dent in that number (there are lots of interesting things being tried, but none of them have panned out yet, despite what [pick your favorite popular science magazine] might tell you).
For the second, I'll "cite" the entire anti-vax community as my counter example. But also see my comment about GWAS and reproducibility (and do the research yourself, it will help you understand how complex and incomplete the data actually is). Most of the science around genomics is not settled yet. And even in the cases where it is, there's still a lot of uncertainty around appropriate responses and treatments.
I also challenge you to get your genome sequenced and analyze the data yourself. And by that, I mean actually get your genome sequenced, don't do 23andMe's microarray panel. Google "whole genome sequencing service providers" to get a list of places that will do it for you. Go for 30x coverage to get data you can use for variant detection. Do an exome panel if WGS is too expensive for your budget, you'll get most of the useful information with that.
The ability to sequence individuals is definitely one of the most interesting things going on in biology right now, but it's still in its infancy as far as our ability to understand and apply it. We'll get there, but it's going to take time and effort.
-Chris
I don't have the citations where I can get at them anymore, but it's relatively common knowledge in the drug development community that there's a lot of relatively strong candidates that die in development for no other reason than the money required to push them through the FDA tests, meaning that while I agree that the science of genomics is in its infancy, I'm not quite comfortable betting that we might not end up in the very awkward position of simultaneously having genomics being well-accepted in the scientific community with strong, reproducible results being the norm and no FDA-approved tests for the medical community because no company feels it can break even because of the costs and legal issues involved in FDA testing.
Regulatory burden is something to always keep in mind--and there's some failures involved here on the FDA's side. Regulations that significantly increase the costs involved need to actually deliver what they promise, if nothing else because the costs of those regulations are ultimately paid by the very same public they are supposed to protect.