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Theranos Voids Two Years of Edison Blood-Test Results (wsj.com)
299 points by ssclafani on May 19, 2016 | hide | past | web | favorite | 167 comments

"One family practitioner in a suburb of Phoenix said a Theranos representative dropped off a stack of 20 corrected test reports a few weeks ago. Many of the voided results were for calcium, estrogen and testosterone tests.

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.

Walgreens really blew it on this one. The executives responsible for Theranos deal all got canned years ago for unrelated reasons.

NYT had an overview of Walgreen's struggle.

http://www.nytimes.com/2016/04/22/business/a-once-avid-ally-... "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."

Walgreen ownership has been bad for Boots and bad for the NHS: http://www.theguardian.com/news/2016/apr/13/how-boots-went-r...

Walgreens has long been a creepy organization. Their checkout clerks were paid on commission to hawk upsells like vitamins.

A lot of retail forces cashiers to upsell shit, like when I was a cashier at Whole Foods and we had to ask customers to donate to the Whole Planet Foundation.

How often does someone actually donate?

You'd be surprised. Esp in Palo Alto.

They should just give to that guy who stands outside in the white suit, collecting money for that drug rehab center, all year round.

They stopped selling tobacco though.

That was CVS.

That was CVS.

That was CVS.

> It would be shocking if Theranos survives this.

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.

That doesn't mean anything much. The equipment could have been ordered months before and if so, was likely on a NC/NR (No Cancellation/No Return) purchase order.

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.

As in, you mean you're still willing to bet that everybody involved WILL come out fantastically rich, despite all the major setbacks thus far?

An aside: doctors shouldn't be discussing people's test results, even if they anonymize and/or aggregate the patient data, without previously receiving consent, and even then I don't think it's really wise to provide quotes like this to reporters.

There are well-considered standards for patient anonymity. Saying "I had a patient with X disease" is not compromising the identity of the patient. Without that, doctors couldn't teach medicine to med students or explain their cases at conferences.

Fair enough, but I'm not sure that will be good enough for much longer. With bigger and better datasets it should be increasingly easy to de-anonymize someone based on just knowing something like that.

Something like what, that a specific doctor has treated someone with a specific condition? I'm not sure that's enough metadata.

I can confirm that's not and could never be a HIPAA violation. The information that Doctor X once ordered a blood test for John or Jane Doe with Result Z is totally fine. There's no non-HIPAA violating metadata that could make that information useful.

There are papers about de-anonimizing patient records and they show that for instance, patient records + facebook is definitely enough to fill in the names correctly.

You do realize that with your standard of never-say-anything you're calling pretty much 200 years of medical study on violation.

That sounds great until you read the original stories detailing how they arrived at these standards.

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.

> 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.

Actually, sufficiently aggregated health data is generally fine to release publicly since it can not be tied to an individual. Anonymized data you must be very careful with, since individual data elements can frequently be combined to re-identify someone.

In support of your point about "sufficently aggregated" data, I occasionally work on projects that publish aggregate health statistics, and you have to be very careful about the size of your denominators. For instance, even without telling what numbers you are dividing, you probably couldn't publish the percentage of HIV positive results among pacific islanders in Nebraska. Because there might be only six such people.

Oddly enough, it turns out to be 836(!), which is definitely higher than I would have guessed.


Those are presumably not all HIV positive.

Yes, but what personal or privacy-compromising information does "6 of this list of 836 people have HIV" convey? That that population has a higher-than-normal incidence of HIV as compared the US at large? That's potentially valuable aggregate health information, but I don't see how that compromises anyone's privacy.

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.

Good point!

IIRC this is why HHS and HIPAA regulations specify "all ages over 89" as protected health information for purposes of data deidentification – there just aren't that many people who have lived that long.

It also specifies all date elements for patient-specific events (including treatment) more specific than the year must be removed for deidentification generally.

So "I treated a skier with a broken leg in the last skiing season" is something a doctor can't say? (Skiing season is shorter than a year.)

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?

All of the responses to my comment are missing the point: you're discussing medical researchers. This was a random doctor in the affected area who spoke to reporters.

I'm quite aware of what is acceptable to release in a medical context; this was not that.

I'm not sure what the problem is though. In all likelihood the doctor has been trained on HIPAA procedures.

And yet seems to have violated them (I've cited the specific section of regs elsewhere in the thread). But deidentification is one of those things people who don't freak with it often, even trained in the rules, always seem to think is easier than it is.

I never said the doctor violated a law. I think what the doctor said (in speaking about a specific patient): "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." was ethically dubious.

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 quite aware of what is acceptable to release in a medical context; this was not that.

I'm sure you'll be able to cite the regulation that was broken, then.

That's not quite how HIPPA works. I don't see anything wrong with the amount of information given here. How else could they talk about stuff like this, anyway? It's important to get out there for people to be aware of.

As long as HIPAA rules are followed I don't see an issue. Further more I would argue that the doctors in this case have a moral imperative to inform the public just how harmful these faulty test results have been. It is becoming clear that Theranos has harmed patients and public knowledge of this is crucial to discover more cases and inform those whom may have had medical decisions made on faulty testing.

Unless specifically cleared by a deidentification expert as provided in 45 CFR 164.514(b)(1), this doesn't meet the requirements of HIPAA for deidentification of information derived from PHI, since it does not remove "All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death" [0], in that it includes the specific month of the test.

[0] 45 CFR 164.514(b)(2)(i)(C)

No your interpretation is wrong. Date does not means month. Date contains Day/Month/Year. Here are 2.5 Million raw inpatient visits released by New York State meeting criteria for HIPAA Limited data, as you can see not only do they contain month and year but also day of the week. [1,2]

[1] http://www.hopkinsmedicine.org/institutional_review_board/hi... [2] https://health.data.ny.gov/Health/Hospital-Inpatient-Dischar...

Date consists of day/month/year, yes.

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.

Actually individual physicians who have treated patients have far far lower requirements, otherwise they would not be able to discuss cases with their colleagues and would have a chilling effect on practice of medicine. What the links show is that its considered acceptable even at level of millions of patients.

I might be missing the obvious, but I don't see any months in the de-identified dataset you linked?

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.

that's the kind of thinking that is the reason we have such bad medicine.

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.

Are you suggesting all health records should be available to the public?

Yes, they should. And they should make it easier to do so. Privacy in medicine is holding us back.

I'm based in SV, and I see a lot of big name entrepreneurs rallying behind her and I don't understand it. You cannot be cavalier/lean about human life. These people deserve to be jailed.

SV is undergoing it's biggest transformation ever. The establishment is being formed, instead of tinkering in garages in sweatpants. This new corporate formulaic way of "staring up" protects their own elk, since the value created is often no longer in the product, but is rather based on connections, like in the East Coast old boys clubs.

Yup. And it's sickening to see people tout this model as some kind of "meritocracy". No, it's a system of privilege and connection, just like many others.

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.

> Gotta have a degree.

A lot of what you said is based on truth, this isn't.

But this is bound to happen whenever a region reaches a level of success. There will be incumbents who are enjoying their cushy positions which they rode into when the times were greater than ever (e.g. Boston Brahmins, people in 'company towns', early mom-and-pop/neighbor/Stanford-prof/etc. investors in SV companies like Google, FB, etc.). The children and proteges of the first couple of successful generations of Bay Area are now working age or older. They have their own networks formed in high school, neighborhoods, parents' companies and so on. I think this kind of establishment of an establishment starts once the first successful generation has children. One indicator of the 'establishment' is you have people using family connections- 'my dad's friend is the VP of blah blah,' etc.

Theranos failing would have contagion effects for investor sentiment and the outcomes of other startups completely unrelated to Theranos.

That is why it so totally needs to happen.

Oh no.

>That means some patients received erroneous results that might have thrown off health decisions made with their doctors.

Put them in jail.

I don't think all the money they've raised so far is sufficient to settle all the claims that will be made against them. The company will not ever be worth enough to settle those claims. In a just world, their assets would already be frozen.

They have very very few assets. The $9 billion valuation is a paper valuation that can vanish in one night.

You can pierce the corporate veil if there is willfull and intentional fraud. Doesn't always happen, but it's possible.

And what, compensate people with the stock of the company that was found to be willfully and intentionally defrauding them?

No, compensate people with the money of the stockholders. That's what piercing the veil means: culpable stockholders assets are no longer protected from liability.

It requires that the particular stockholders be actually culpable and involved in the fraud - fraud done by non-owning management would not allow to capture funds of non-managing investors.

piercing the veil usually applies to manager-owners, like S-corps. If I invest in a corporation and the managers do something horrible, the managers could potentially be reached through the veil, but not the stockholders -- their only involvement was handing over money, so they had no wrongdoing.

Now, investors who are also decision-makers on the Board or maangement, that's another story.

What I'm saying is the culpable stockholders (Holmes being the primary one) have few assets.

They have taken in over $400,000,000 in investment, I'm sure there are more than a few bucks laying around.

I'm sure their insurance is still paid up.

> In a just world, their assets would already be frozen.

Who would one contact in the federal government to ensure the right folks were looking into this?

I'd be shocked if they weren't. But the Feds like it when private suits do the heavy lifting first, and they cruise in and take a quick victory. Civil plaintiffs have broad discovery powers (pretty much going to be able to read all the important insiders emails about the company) that the Feds lack.

Shouldn't CMS be doing that?

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.

Unfortunately, it seems unlikely there's a public and open tip-line for general corporate malfeasance (that anyone's paying attention to anyhow).

Fortunately, I think the feds are already on the case.

There are links on the SEC's and FTC's homepages for filing complaints, reporting antitrust violations, submitting tips, and reporting identity theft. There are probably more but I only spent about 30 seconds looking.

This is what happens when you try a Minimum Viable Product in healthcare and aren't up-front about slower than expected R&D progress.

It also doesn't look good when you fail this hard without a credited scientist on your board.

And the one who was took his life, and reportedly told his wife "nothing's working."

I don't believe he was on the board of directors if that's what you mean.

edit: incorrect statement about C-level positions.

Chief Scientist or, somewhat more commonly, Chief Science Officer is a typical C-level position in biotech -- and possibly other non-software tech -- firms (roughly equivalent to a CTO in software firm.)

Couldn't agree more. One has to wonder the limits of the move fast, break things philosophy.

Move fast and break people.

It works when the things are non essential pieces of computer code or entirely unmanned test vehicles e.g. SpaceX landing attempts.

In medicine, manned transport, etc. it's criminal.

This is NOT a failure for MVP in healthcare.

> "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.

The lack of transparency thing is a huge red-flag.

Based on what little information is available so far it sounds like they did not have an acceptable false positive rate. I'm wondering if the secrecy allowed them to hide the underlying statistics, maybe not even intentionally.

This is so stupid and a huge step backward from the consumer protection advances of the 20th century.

aren't up-front about slower than expected R&D progress

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?

Since fraud is a crime, my answer would have to be "when it's proven in a court of law".

Interesting they couldn't even user other peoples machines

"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."

I think this is consistent with an institutional interest in going through the motions of diagnostic tests, but not caring about accuracy.

This is likely the beginning of the end. With such a massive loss of trust, especially in the healthcare space, it is hard to see how the company could ever recover in the eyes of customers, investors or employees.

Holmes will have to go and be replaced by a perceived 'grown-up' CEO. That's the only way (and even that is a longshot) the company ever recovers.

She has voting control, which is why she is still there.

[1] http://www.forbes.com/sites/petercohan/2015/11/03/theranos-l...

I agree. However, it sounds like they don't really have a real product or anything to sell. I think the company imploding is more likely.

Will Holmes have to face any consequences for her company providing false results and making false promises or can she just walk away with a bag of money?

She has certainly already been able to divert to herself a good chunk of her investors' money. And it's unlikely that she will ever have to face personal consequences for her decisions.

Maybe she will run for president in a few years. She certainly has what it takes for a successful political career.

I'm a lot more skeptical than you. She could face fines, even worse PR than now, and jail time. I don't think she'd be successful running for office after her funded company tanked because it misled everybody about their ostensibly revolutionary technology for a decade.

Trump University anybody?

Trump Holmes has a nice ring to it.

My personally favorite one is Trump And The Empty Jewelry Box Scam

how would she have done this? most ceos just get a salary and equity; if the equity goes to zero, which is increasingly looking likely, then all she got was a salary for all the years that she ran the company. i dont think that qualifies as diverting a "good chunk of her investors' money."

It's called "taking money off the table", and it's actually pretty common in later funding rounds. The founders sell some of their personal stock to investors for an often significant amount of money (multiple millions of dollars).

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.

She may have sold some of her equity in the company.

They can just change their name.

Can someone put this into perspective...how often are there major recalls or calibration issues at other, more established labs and testing companies?

Certainly, not trying to defend Theranos, just trying to understand how bad this really is. Because it sounds pretty horrible...

From the article:

“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.

I agree that this is big, bad, and infrequent.

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?

My guess -- some nasty implicit or explicit "you talk to the press and we'll sue you into oblivion" agreements that employees had to sign.

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.

1. https://www.glassdoor.com/Reviews/Theranos-Reviews-E248889.h... (look at the one-star ones...many of the rest are suspiciously booster-ish)

2. How do you think the original WSJ article came about? http://www.wsj.com/articles/theranos-has-struggled-with-bloo...

I guess I was hoping that it was a bit of hyperbole on WSJ's part. Sounds like Theranos truly fucked up.

Nope, this is a big deal. Carreyrou's been pretty even-handed throughout his reporting. Hard-hitting, but he's not telegraphed an agenda other than trying to figure out if there's anything really behind this company or if it's all a massive fraud.

there definitely are recalls and calibration issues all the time. But this is very bad, possibly a fatal blow for the company.

This is an Epic Fuck Up that will be discussed for decades in legal, technology, VC, and startup circles. It makes it effectively impossible for a non-established player to innovate in the space for at least 5 years. Additional regulations will hinder innovation for far longer. People will go to jail.

Ironically Holmes might end up getting her wish about all Lab Developed Tests (LDTs) needing to go through FDA approval in addition to CLIA certification, which cover the operation of a lab, not the design and validation of the machines in the lab.

This series of events will create a business case for the ages, one that MBA students will read right after they study the J&J Tylenol crisis of 1982 (http://www.ou.edu/deptcomm/dodjcc/groups/02C2/Johnson%20&%20...)

I am not familiar with the actual laws involved in this kind of case. If it were proven that a Theranos tests harmed a patient and that Theranos willingly obscured the accuracy data to regulars could Holmes be held criminally liable?

That would likely fall under a civil statute. But criminal fraud seems likely. I'd be willing to take a bet on even more trivial matters like falsification of evidence once things started to go south ("it's the coverup, not the crime"). Investigated properly this will probably blow up the FDA too.

"Theranos has declined to quantify to Walgreens the scale of its test corrections"

Doesn't seem like they're learning anything.

Using "https://www.google.com/" as Referer (with the 'Referer Control' extension for example) gets around the paywall

You can also insert a "?" at the start of the URL which will search Google for that URL, the article itself is the first result.

Web link at the top of this comment page does the job.

Any idea how to do this in mobile ?

Just search for the title / url in google and click on it to get use google as referer

HN has [web] links under the title. Click that, and it launches a Google search for the title. Click the result.

(It'd be nice if we could set, in our options, alternative like DuckDuckGo or Bing)

Again, one of the most important interviews with Holmes: https://www.youtube.com/watch?v=MBs-oj7U-bo

Edison is discussed. "We don't use Edison for anything and haven't for a few years now."

Can someone please summarize what this actually means? The article is behind paywall and the title is cryptic.

What does "void" mean ? Less accurate, completely wrong, completely random ? What does Two years refer to ?

You can use the 'web' link

The class-action lawyers must be salivating over "tens of thousands of corrected blood-test reports"

Yes and no. While there is likely a claim if the company is now unviable there may not be any money to claim. Blood from a stone and all that.

I imagine there is enough negligence here to target the officers and directors directly in a lawsuit.

> Blood from a stone and all that

You just need one drop tho.

if you came here without reading the article, all you need to know is that Theranos is fucked.

I was extremely optimistic for Theranos and having to see them go through this is sad on so many levels. Not calibrating standard testing machinery correctly just does not cut it.

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.

This is not what disruption looks like. This is what happens when you have someone with no domain expertise, but a great idea. We're seeing the same thing happening with Zenefits. Founders with no domain experience need to look at how they're going to enter a market full of incumbents. These incumbent businesses have survived for years because they know how to play the game. They have people in their employ that know how to lobby the right regulatory bodies. Theranos had none of this. So when all of this started coming down, they should have hired the most well-known and respected person in their field to bridge the gap between the past and future. Without that, they are outsiders playing in a game that has been around forever. They were set up for failure before they even began and no one was smart enough to ask "How will they disrupt an industry that has been around for decades?" Just saying, "We're going to make medical tests cheaper and more accessible" was clearly not the right answer.

> They have people in their employ that know how to lobby the right regulatory bodies. Theranos had none of this.

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...

Disagree. Elon Musk had no domain experience in payments, cars and rockets. Fresh eyes can be invaluable. And it's not that hard to avoid "pulling a Theranos". Theranos should not be an excuse to discount lack of domain experience.

But I think it's very important to note that Elon surrounds himself with the very best domain experts he can find. He also has a reputation of deeply engrossing himself in a topic to learn as much as he can. While he may not be a domain expert when we starts, I believe he does eventually becomes one.

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.

The key difference though, is Elon Musk brought in people that did have domain expertise to fill in the gaps. The overall vision is Elon Musk's, but he was smart enough to bring in industry veterans to help execute on that vision.

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.

Is there any evidence that Theranos didn't bring in the best people in the industry? They certainly had the money (and stature) to do so.

Yes. Up until a few weeks ago, Theranos's board consisted of mostly ex-Pentagon and ex-Senators and such types [0]. Theranos did not have a medical advisory board until about a month ago, apparently.

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 [1].

[0] https://en.wikipedia.org/wiki/Theranos#Governance

[1] https://en.wikipedia.org/wiki/Tom_Mueller

Lightening doesn't often strike twice. One success out of many doesn't mean people shouldn't do their homework. Entering the car market is not the same as entering the world of medicine where the results from a test Theranos conducts could result in endangering a life. Elon Musk surrounded himself with domain experts.

Case in point, http://www.theverge.com/2016/5/13/11674590/tesla-vehicle-pro...

> could result in endangering a life

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.

Tesla's non-autonomous driving technology can also endanger lives.

> We're seeing the same thing happening with Zenefits

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.

But he didn't know anything about being a broker, selling insurance, or that industry in general. He used tech and savvy to disrupt, but he disrupted the ways established players never would have because he was so ignorant and headstrong.

Theranos didn't have a great idea. They had a great fantasy.

The reporting by Carreyrou is particularly insistent to put Holmes front-center in each of this series of articles. She's in the article subtitle and first image again. I wonder if other execs are also responsible for this disaster.

So when is the Edison estate going to issue a cease order against Theranos for using their name and damaging the reputation?

I still believe in the idea of Theranos and while I think it is great the Ev Williams was able to secure funding 2 more times to keep rebuilding different versions of blogger[0], I want to live in a world where we also take huge gambles on hard problems. If we adhere to VC math (we should as this hypothetical is for VC investing) one of these payouts will be well worth it, e.g. Tesla/SpaceX. So yeah, I'd write down uBeam & Theranos, but you can fuck off if you want the world to stop investing in big ideas.

[0]twitter.com, medium.com

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.

They could have just failed. Never produced a technology. Wasted a bunch of money and all would be fine. But messing up medical tests while you are "figuring it out" is unacceptable.

That is fair. It stings the most because the medical industry is known for it's transparency and rigorous testig standards. The FDA, famous champion of public health, was able to successfully stop 23&me (information terrorists) from providing harmful information to their patients as well. It makes sense tha Theranos should be singled out and villified for the failure of one of their beta devices that was i active development. Obviously, lieing about it wasn't super cool, but again their product "figures out and produces medical tests" so messing up your product(or procedures involving it) is === messing up medical testing.

I would have said the opposite - that the healthcare industry is known for its lack of transparency, with big pharma being notorious for their obfuscation.

i was being sarcastic. either way, given the threads discourse, moonshots seem to be a super unpopular idea except when google does it...

I also thought that you were being serious. There is a good reason people use explicit markers for sarcasm like: <sarcasm> </sarcasm>

I encourage you to look up Poe's law

I don't see an issue at hand of not investing in big ideas. In fact it has become clear that what has been invested in was ideas alone with insufficient substance.

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.

this is a reasonable counter claim and the middle ground I was looking for. Everyone pounces on Theranos, which was founded by a research student who dropped out of college in 03, which is 13 years ago. It irritates me that people come out in condemnation of Theranos like a foregone, obvious conclusion they would have been fully equipped to make 13 years ago.

Maybe they could have used the best search engine to do due dilligence[0]. 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.


If you could manage a ratio of 5 big losses for one massive hit you'd be quite a successful investor indeed :)

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.

I don't understand your reasoning about this. It's obviously not a big deal that the technology might be a sham. Who cares about the investors losing money.

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.

Call it research and just say we're not launching a product until we figure this out, even if it costs us a hundred mil. That is OK. Minimum Viable Producting your way in a space like this is NOT OK.

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.

I'd suggest it isn't even a Minimum Viable Product. That at least implies some sort of working diagnostic.

> I still believe in the idea of Theranos

Several studies suggest that small volumes of blood have too much variance to yield useful test results.

Would you mind including those? As a non medical expert, nor physicist it doesn't seem implausible that medical testing can be improved 10x from where it is and many other competitors to Theranos seem to be raising capital (Healthtell >25M recently) so the consensus doesn't seem to be insurmountable && obviously scientifically impossible. Again, I am not favourably comparing Holmes to Musk, but it is narrowly physically possible to go to mars, certainly we have a bit more clarity on local testing of blood.

> 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.

It's also possible to question the idea the idea that are testing leads to better outcomes in the first place.

It's not 'we have no idea how to do this' impossible, it's physically and technically impossible?

Judging from what I read in comments on Derek Lowe's blog, the problem is not so much being able to do blood tests on µL of blood (which I suspect we might have the technology to do; whether it's cost-effective is a different question) but rather that the way you get only a little bit of blood screws up the results--you're extracting more from capillaries than veins, and you get more contamination from skin and other tissue cells.

What about big ideas that hurt people?

Those are usually called medical trials. And the people participating in them have reason to believe their participation may not be dependable. This is not what Theranos was selling.

Idk to be honest. I have been able to morally justify using electricity, nuclear energy, certainly all of the "modern medicine" I enjoy at other people from histories expense, ect.

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