The doctor said one corrected report is for a patient she sent to the emergency room after receiving abnormally elevated test results from Theranos in late 2014."
Tort attorneys should be licking their lips.
It would be shocking if Theranos survives this.
Beyond that Walgreens - the largest retail pharmacy chain in the USA and Theranos' wellness center partner - should also be in the crosshairs.
Feels like they should have had some better safeguards for consumers before committing to the 40-store pilot in AZ.
NYT had an overview of Walgreen's struggle.
"The Wall Street Journal reported that Walgreens was so eager to cement the relationship that it lent Theranos money, acquired warrants to buy Theranos stock and skipped its usual due diligence when evaluating a pharmacy partner."
"The Walgreens executives responsible for the Theranos deal, including Mr. Wasson, as well as the chief financial officer and the president of the company’s pharmacy unit, have all been replaced, forced out in 2014 by activist investors after Walgreens acquired the European drugstore chain Alliance Boots."
According to the last paragraph, they're still expanding.
"Last week, Siemens delivered lab equipment to a Theranos facility in the Harrisburg, Pa., area, according to the person familiar with the matter. The person said Theranos is preparing to open there what would be the company’s third lab."
I'm still not willing to bet everybody involved won't come out fantastically rich.
When I was in the business, we built stuff more or less to order. You don't want to warehouse a bunch of machines that cost you almost $100k each to build.
I mean it's utilitarian attitude on the surface, but the usefulness of medicine will be significantly degraded for everyone if patient records become public records.
Huh? The reason why doctor-patient confidentiality exists is to encourage people to seek treatment without fear of embarrassment or retaliation.
It would if you reported "6 of 836 were HIV+ on Tuesday. The next day, a new couple moved into town. On Wednesday, 7 of 838 were HIV+." I don't think the aggregated data that is contemplated here is released on nearly that frequency.
Actually, giving a year of a winter/summer sport-related accident already provides a shorter window for when the accident has occurred. So should all case reports about such be giving at least a two year long window?
I'm quite aware of what is acceptable to release in a medical context; this was not that.
Most of the people who are replying negatively to my comments are misinterpreting my position: either suggesting that I implied there was a HIPAA violation, or that I think medical research data should be suppressed. Neither of those is true.
I'm sure you'll be able to cite the regulation that was broken, then.
 45 CFR 164.514(b)(2)(i)(C)
Elements of date other year, what must be removed to meet the blanket, by element test, means both month and date must be removed.
The alternate standard, which is typically used by large scale releases, is review by a professional expert (the specific expertise and determination is in the reg I cited) to validate that they aren't reidentifiable.
Your first link is not what you describe, it's a description of the definition of a limited data set under HIPAA, which can be disclosed for research, public health, and health care operations purposes. It notes that it can include full dates, and also explicitly notes that it is explicitly not considered deidentified, but is still PHI under HIPAA.
Your second link is unrelated to the first, and does contain day of week and year, but I don't see month. In any case, it's the kind of release from the kind of organization that is likely to have professional on staff and not rely on the blanket, by-element deidentification standard. That's not true of most practices and practitioners.
Your second link also says a limited dataset is considered PHI and can only be shared with third party under certain conditions and with a data use agreement.
medicine and all its research needs to be open, people have no privacy anywhere else, and to keep insisting on it for medical data is only allowing governments and huge corporations to take advantage of our lack of knowledge about drug affects etc..
the major reason there is even a debate about vaccines is because of this weird belief that we need to keep medical records siloed from researchers and the public when this information is probably of the highest value to us as a society.
but instead we just post everything else about ourselves on the Internet and those things can actually be used to hurt or segregate us from knowledge that will help us overall.
one of those weird things I've never understood about society's ability to be completely distracted from its own self interest.
Gotta live in the bay area to start, that alone is a challenge unless you're already wealthy. Gotta know who to talk to and how to talk to get money. Gotta have a degree. Gotta have friends who can be your co-founders/early employees or connections. Gotta know how to look right to the angel investors and the VCs.
The idea that the average invested company represents anything more than a group of people with an in and a talent for schmoozing is easily refuted just by observation. Sure some of them have solid fundamentals, but most are bullshit.
There was a tweet, since deleted, a while ago by Ben Dreyfuss (son of Richard Dreyfuss) who is now a writer at Mother Jones. He was attempting to explain how everyone assumes his parents carried him and related the story of being given 140k by his mom to try to make it in Hollywood, after three years he ran out of money and gave up. That story, along with Trump's "small loan of a million dollars" is really not so different from the typical SV startup story. There are countless small companies who are given "small loans of a few million dollars" based on who they know and generally seeming like they aren't complete morons. And yet few in that system would draw a parallel to the sort of privilege and wealth of Trump's ilk, though substantially there are many similarities.
The folks in SV tend to dress down and avoid excess signs of luxury until they've "made it" proper, but it's not as far removed from rich parents giving their spoiled children cushy jobs in the family business as most people would hope.
A lot of what you said is based on truth, this isn't.
Put them in jail.
Now, investors who are also decision-makers on the Board or maangement, that's another story.
Who would one contact in the federal government to ensure the right folks were looking into this?
The article mentions CMS threatening to revoke their license, it seems like they would be inviting in a law enforcement investigation if they felt it was warranted.
Fortunately, I think the feds are already on the case.
And the one who was took his life, and reportedly told his wife "nothing's working."
edit: incorrect statement about C-level positions.
In medicine, manned transport, etc. it's criminal.
> "The inspection found that Edison machines in the lab often failed to meet the company’s own accuracy requirements."
I'm assuming that accuracy is part of their MVP definition. Theranos is massive disaster, but it wasn't because they released a minimum product without all the desired features at once. The product seems fundamentally broken.
This is so stupid and a huge step backward from the consumer protection advances of the 20th century.
Why are people so quick to dismiss obvious fraud in terms like this? At what point do people begin to understand that peddling snake oil in this manner is securities fraud, and possibly even health insurance fraud?
"A person familiar with the matter said the Arizona lab performed the blood-coagulation tests with a traditional machine from Siemens AG that was programmed to the wrong settings by Theranos.
The Arizona lab also failed several tests to gauge the purity of the water it uses in its Siemens machines, which could affect the accuracy of some blood tests run on the devices, the person said."
Maybe she will run for president in a few years. She certainly has what it takes for a successful political career.
Investors agree to this for a few reasons. Firstly, it's a way for them to get a larger stake in the company. Secondly, it reduces the risk of the founders taking an early exit because they are strapped for cash. Finally, in a competitive deal (against other investors) it can be a way to sweeten the deal and get selected over the competition.
Investors don't want founders to be worrying about money - they want them to be focusing on their company.
Certainly, not trying to defend Theranos, just trying to understand how bad this really is. Because it sounds pretty horrible...
“There have been massive recalls of single tests in the past, but I’m not aware of one where a company recalled the entirety of the results from its testing platform,” said Geoffrey Baird, associate professor in the department of laboratory medicine at the University of Washington in Seattle. “I believe that’s unprecedented.”
Based on my ~10 years experience in device/diagnostic industry, I concur with this assessment. I don't think anything at this scale has ever happened. There are only two reasons a diagnostic company would issue such a sweeping retraction of test results:
- The product just plain doesn't work
- The administration of the product (lab procedures, etc) was so shoddy that accuracy can't be guaranteed.
Either of those conclusions is damning. Generally a company tries to limit the scope of the damage, either by scoping for type of test, i.e. "Oh well Edison is fine, but this this particular test (say cholesterol) is failing. The other tests are fine though" or scoping for time "We had some poor lab procedures from September thru December but we cleaned house and we're all better now". The WSJ report implies they did neither.
What I keep asking though, is where were the employees in all this? I also spent over a decade in the device industry, and everyone I worked with, from biochemists to engineers to Regulatory Affairs people would have been screaming loudly. We took patient safety very seriously. Any suggestion that our instrumentation was defective was immediately investigated. This is typical in the medical device industry. I can't believe that the rank and file people working at Theranos were really any different.
So where are their voices?
Which you and I know are especially illegal in the life science industries at the federal and state (in most states) levels. But given how secretive Holmes was toward potential investors and customers this would not surprise me.
2. How do you think the original WSJ article came about?
Doesn't seem like they're learning anything.
(It'd be nice if we could set, in our options, alternative like DuckDuckGo or Bing)
Edison is discussed. "We don't use Edison for anything and haven't for a few years now."
What does "void" mean ? Less accurate, completely wrong, completely random ? What does Two years refer to ?
You just need one drop tho.
One of their notable contributions is to set precedence in Arizona where consumers can now order their own tests without doctor's orders.
I believe consumer awareness of state-of-art diagnostic resting and making testing readily accessible can have a fundamental impact on people's wellness.
ps: I am not advocating more testing.
No, I think they had plenty of that, look at the makeup of their board. Maybe not exactly from lab testing background, but plenty members with heaps of biotech, pharma, legal and government experience. What they were lacking was a workable product to lobby for. Which I guess is a silver lining to this - that even a $9 billion lobbying effort can't overcome straightup fraud, at least in the biotech sphere. Finance, on the other hand...
Theranos shouldn't be an excuse to discount domain experience because fundamentally the impeding failure of Theranos isn't due to lack of domain knowledge. It was pushing their product before it was ready and misleading doctors and the public as to the accuracy of that product.
Elon would be "pulling a Theranos" if he obscured failed launches and solicited launches without being transparent on SpaceX's capabilities.
I think its also worth to keeping in mind that SpaceX nearly went bankrupt in the process. I wouldn't be entirely surprised if the rational behind Theranos's actions were caused by financial pressure. But that's just my speculation.
Theranos, on the other hand, appeared to not have done that. Or at least not on a scale necessary to succeed, especially in something like healthcare.
Contrast with Elon Musk and SpaceX. One of Musk's first hires/co-founders for SpaceX was Tom Mueller, who at the time was already widely regarded as one of the best rocket engine designers in the world .
Case in point, http://www.theverge.com/2016/5/13/11674590/tesla-vehicle-pro...
So Tesla's autonomous driving technology couldn't endanger a life? The fact is, driving an automobile is the most dangerous thing a person does on a daily basis (outside of simply being alive).
Given the number of safety recalls we're witnessing in the automobile industry right now, the number of deaths that occur every year from automobile wrecks, and given how inherently dangerous it is to manually drive a 3,000+ pound piece of metal down the road at 70 mph, I'd say your premise is very off base.
Sorry to contradict, but that's plain wrong. Both the founders of Zenefits - Parker and Laks, know more about the insurance industry than your average broker. It was Parker's frustration with the amount of insurance paper work he had to deal with at his prior company, that led him to actually start Zenefits so that the pain can be eased for others.
edit: Also, we can assume it isn't physically impossible to use smaller amounts of blood to perform tests. So yeah, it was super obvious from the beginning some immigrant who happened to be in the right place at the right time and make some money at the height of the DOTCOM era working in software couldn't build a sustainable rocket program that rivals that of 1st world nations. So it wasn't obvious, and the next big innovation won't be obvious, and if you think it is you are either building it or just straight up wrong.
I encourage you to look up Poe's law
But for healthcare there is a simple golden rule: Primum non nocere - First do no harm.
Theranos has broken this rule in an absolutely egregious way. I would hold no issue if they failed and that was that. It would be upsetting if someone got hurt because of some failures which were not picked up by regulatory adherence, but sometimes things happen and I wouldn't hold it against them. But to willfully hide the inaccuracy and poor performance of your healthcare product? To allow it to be marketed to doctors and the public as just as effective and accurate as existing tests?
I'm not certain if it is criminal, but I believe it at the very least should be. The individuals who have caused this to happen should be held responsible.
As for the uBeam & Theranos comparison, I don't believe it to be completely fair to Theranos. Had they had more time and not horribly cut corners as they had, then perhaps Theranos would have become the billion dollar world changing company it was hyped to be. There is still plenty of research and science that needs to be conducted in microfluidics before we can conclusively declare weather or not it can work.
But uBeam was dead on arrival. The core assumptions could be challenged with a basic understanding of physics. There's a big difference between, we don't know how to do something because the science is still being collected vs we know this won't work. Investors fell in love with a cavalier founder that had rebuffed the experts.
Maybe they could have used the best search engine to do due dilligence. Of course it was google, they had just taken 29% market share to eclipse yahoo by ~1%. So yeah, with 13 years of hindsight and a decade of research the 20 year old college whiz didn't build a successful company. Like you pointed out, there are a reasonable subset of things you should expect(even from a failing company) and I believe you are correct.
It would just be nice to see a bit more contemplative thought around Theranos. Quite obviously they made major mistakes, had some ethical violations which regardless of being par for the field are piss poor from a judgement and statistical validity standpoint, and other short comings.
I'll gladly be the person that says I would fund 5 Elizabeth Holmes if I could get 1 Elon Musk/Steve Wozniak/Bill Gates ect. and I think we all know, that would be too cheap a price.
Microfludics itself was still a young science at the time Holmes founded Theranos. It still is. I'm not sure if she could have really done due diligence that would have provided an insight how Theranos turned out at the time. I believe this was one of those try it and see if you can make it work science problems.
Having built a microfludics chip as a student, I do still think that there is plenty of promise the technology. I hope life science investors don't shy away from it. Just perhaps ask for more supporting evidence of claims. And extraordinarily evidence for extraordinarily claims.
I think the phenomena that you're seeing is a result of the kind of personally cargo cult that surrounds leaders like Holmes. As everyone sees the shadow of Icarus pass over them they marvel at his brilliance. Try to soak in every detail less they too can figure out how to soar just as high. And then when Icarus falls suddenly everyone who held him in such high esteem feel foolish. "I'm no fool, of course he was going to fall."
At least that's my theory.
I do empathize. I've been working on a product which started with very ambitious goals. It's been painful cutting out capability. I'm going to ship a product tomorrow that is less advanced than the designs and prototypes I have from a year ago. But it works consistently and I can use it as a the foundation from which to build upon. And if anything, I think the lesson from Theranos is that in healthcare the path to MT. Olympus must be a slow and steady climb. Skip a step or try to move forward before you have good footing where you are now and you'll fall.
It's a huge problem that they provided bogus results to patients.
Here's a simple mechanism they could have used to develop their testing technology: While doing the pilot research on the new technology, build up an excellent lab practice using existing tech. Once the pilot tech is ready for wider testing, start using those delicious VC bucks to offer patients a trade; in exchange for a lower price on the excellent traditional testing, they allow you to use their sample to test the new tech against the existing tech.
So the moonshot doesn't requires exposing patients to any additional risk at all.
That is where they effed up and that is why she is liable. Imagine a car manufacturer falsifying information about a faulty brake in a new line of cars.
uBeam's only crime is hyping their half-baked product tooo much.
Several studies suggest that small volumes of blood have too much variance to yield useful test results.
That's misrepresenting it a bit. Currently there are zero blood tests that have a 100% accuracy therefore if you can't do a normal test with an accuracy near 100% you're not going to be able to do it with a smaller subset of data.
However, if we get to the point of 100% accuracy (or at least near) then there is no reason why those types of tests couldn't be useful. But yes today they are not.