Theranos Founder Faces a Test of Technology, and Reputation
nytimes.com
nytimes.com
How was a college dropout able to get a break in the healthcare sector? Becoming a doctor requires years of education and training and along comes this young woman who just decides "I'm going to change all of this." What? I don't understand how a person with no experience, no vetting, no medical training, no engineering training, and frankly a product that I find to be of questionable value ends up getting millions in funding and at the head of a multibillion dollar company.
Perhaps I just don't understand the phobia that some people have around blood tests but it is my understanding that you get a blood test as a way to gauge your health, not because it makes you feel nice. The hold up doesn't seem to be that tons of people are afraid of needles otherwise they would be getting tested all the time. The hold up to people getting blood tests all the time is that doctors don't order them, presumably because doctors don't think people need them. As long as the test isn't extremely uncomfortable for the patient, I would think that accuracy is really the only measure of quality for a test and it seems to me that they are willing to sacrifice accuracy in favor of making people feel comfortable.
Also, why would I ever get a blood test at a grocery store? Why would I ever trust some random employee at a food store to respect my privacy and be medically competent enough to administer a test like that. What exactly do I have to gain by getting one in the first place?
Correct me if I'm wrong on any of this because this is just my viewpoint as an outsider. I would however never get a blood test from Theranos and if I wanted one I would call my practitioner and have them administer one at a doctor's office, not at the local grocery store.
You don't need to be a doctor to hire doctors. Aren't startups supposed to be all about this kind of disruption by outsiders? People who come along and decide "I'm going to change all of this"?
See the Wall Street melt-down in 2009. These are supposedly finance professionals who "lent to the wrong sorts" but that's their only job, determining who and who not to lend to, right?
There's a lot of "boys will be boys" among the upper-middle class and wealthy, whether those "boys" are boys or girls of these families.
The house of cards will come tumbling down at some point, but it won't matter, there won't be consequences.
I know this because I've spent enough time in the world of the mega-rich, had enough passes made at me by apparently well meaning robber barons, to know that this is how this works.
This whole episode is the best justification for the thesis that that VCs are successful, not from adding value, but simply being presented with the best deals. Perhaps that bull at the Dallas Morning News could do as well.
I see her and Shkreli as fundamentally doing the same thing - just she's doing it not like an idiot, like him.
I was a skeptic, but a doctor's suggestion turned me into a believer. It's just that Safeway's the beneficiary of this rather than Theranos now.
Workplaces have also given flu shots for a while now - they had a yearly flu clinic at Google the years I was there, but I always found it more convenient to go into Safeway at my leisure than drop my work during the day and get stuck with a needle in front of my coworkers.
Healthcare founders almost always have either medical and/or science training.
Couple of potential issues: one is that blood tests can be extremely expensive. They are run by delicate, temperamental, and pricy analyzers that have to be babysat by reasonably well-trained personnel. Some tests need costly reagents. Still others aren't readily automated at all and require a lot of manual inspection and interpretation, again by people who don't work for free. Meanwhile, doctors are under external pressure to keep costs down, sometimes to a fault. I think these are the pain points that Theranos is trying to address.
The second issue is the real elephant in the room: statistics. Accuracy is not a simple concept in this business. If Theranos succeeds in commoditizing a large number of blood tests and making them available to people without medical supervision, there will be some unintended consequences. I think these are positive goals -- don't get me wrong -- but the fact is that the traditional medical priesthood is still going to be needed to follow up on the tests. If you run enough lab tests on a sample of your own blood, you will get some positive results for diseases you don't have. A test that's 99.9% accurate for say, HIV, is going to report a lot of false positives if you give the test to people who were never in a high-risk demographic to begin with.
So when a physician decides which tests should be ordered and which ones should be skipped, they aren't just being financially stingy. They're also trying to get at the most likely diagnosis without wasting time on laboratory snipe hunts. I don't think anyone including Theranos can do much about this problem. It's just too hard to come up with a perfect medical test, let alone a perfect machine to execute it.
Prior experience is no prerequisite to start and grow a business into several billions in valuation; ask Mark, Larry, Bill, Steve and 'em.
Making blood tests super easy to take is extremely important. For example such a system could run tests daily and inform you a long time before something terrible happens. It's like cars, before they existed it wasn't very easy to understand how they will impact societies.
There is no Theranos. It's a marketing campaign for a sci-fi movie being released in 2016. (Look at Elizabeth Holmes' (an actress, btw) dress code. Look at their website. Try to find a reference to the company before 2015. It simply doesn't exist!).
After the surprising success of Soylent, MGM decided to cash in with an updated version of Soylent Green. In the future, instead of eating food, people just insert their finger into a machine which analyzes their blood chemistry and makes a delicious beverage optimized for your individual needs. Of course, it also scans your calendar (final exams? Add some ritalin. Important business presentation? Add some xanax. Hot date? Add some viagra).
I don't want to give away any more of the plot, but it stars Elizabeth Holmes and Will Smith (note this is the second remake where he replaces Charleston Heston, the first being Omega Man/I am Legend).
The sell of Theranos was that you could do a thousand blood tests on a few drops of blood. If you could go to Safeway and get an accurate fingerprick blood test, then you wouldn't need a trained specialist to draw blood and collect the blood samples anymore. That's a huge win as well.
It seems less and less likely that is actually possible but if it were and you could get reliable and accurate results, it would really make a difference. It's not just people being scared of needles.
Take a look at Baebies, which is doing exactly this (neonatal screening): http://www.newsobserver.com/news/business/article28910089.ht...
The cofounders previously founded Advanced Liquid Logic, a diagnostics company using microfluidics technology developed in a Duke research lab that was subsequently sold to Illumina for $96M in 2013. Baebies is now licensing that technology from Illumina.
Unlike Theranos, their work has been published in peer-reviewed journals. For example, here's a publication from 2004: http://pubs.rsc.org/en/content/articlelanding/2004/lc/b40334...
Some people think more information is always good. We see healthy people without any symptoms will sometimes pay for "whole body MRI scans".
Some people think that if you have an illness it's going to be seen in the blood.
Frequent traditional blood tests are time consuming and not that pleasant.
Theranos claims that they don't need that much blood; that they can do a blood test with just a drop.
This means people don't need to see a phlebotomist nurse to have blood taken, they can just blot a drop of blood on a stick.
So, the claim goes that people can have very many blood tests all the time, and that will give us more data, and that data is always good.
Theranos plays into some deeply entrenched stuff, so while it's alarming they got so much money it shouldn't really be that surprising.
Let me explain:
Use cases outlined in this article that have minimal real medical benefit, but sound great:
- Home blood testing (why? there are only 2 types of people who may find this useful: patients on Warfarin, and patients on dialysis. Dialysis patients (if not on home dialysis) get tested 3 times a week when they go to dialysis. INR is usually stable once established, ceteris paribus)
- Field blood testing (Mostly pointless. Clinical signs are much more useful in a casualty situation. Arterial blood gasses are useful in resus rooms in emergency departments but in the field you want to keep them breathing, not go reversing exotic blood gas abnormalities)
For the majority of tests (EUC, CMP, LFT, FBC, Coagulation studies) in rural/isolated places, the i-stat machine is used in australia. This is priced ok... around $40 per cartridge for around 6-10 results.
The i-stat works with not much more than a couple of drops of blood as well, although it needs to be drawn from a vein, not a finger-prick.
Other tests, like lipids, or antibody markers, etc, are rarer and much more expensive. It would be great to have them cheap (but again, we don't really know how cheap theranos is saying tests are going to be) which may make them more common, but again there just isn't much benefit in taking them regularly.
Theranos may well be a white elephant. which is unfortunate. The promised technology (fingerprint testing) would be great. But I can't comprehend how they could go for 12 years without a product. And as a doctor, I would be very suprised if the technology works as advertised. There is unfortunately too much hype surrounding this product for me to believe that we will get what has been promoted, but you never know and I would love to be pleasantly surprised.
I wonder how popular this viewpoint will be here on HN - the home of lifehacking and microanalysis of bodyfunction (often without the corresponding knowledge to go with it, but prefaced with a view that 'more data will always be better').
Smart people apparently claim that blood pressure is one of the most reliable indicators of how long you'll live. If so, then it's always seemed strange it's (almost) never measured.
It's still not what you want, but it looks like things are moving in the direction you suggest. That said, I'm wondering if it is even possible to do what you suggest without being inconvenient to the user. Having an armband inflate and tighten around my arm every few seconds with become infuriatingly annoying. Are there alternatively ways to measure blood pressure that are imperceptible?
What I'm looking forward to seeing is conductive textiles making their way into compression clothing so we can measure heart rate all the time. i.e. a wearable EKG shirt. The use case would be older people at risk for a heart attack and heart fail so we can detect problematic heart abnormalities that are predictive of failure.
But now I see that the community actually downvoted your comment rather than rewarded it. Darn.
For what it's worth, and even though this reply is very late: Thank you so much for your time and for the thoughtful and helpful reply. The links, specifically, were the reason it was helpful to me.
It's a very consumer-targeted technology, although it would certainly find a place in emergency departments and ICUs. I am at a loss to think of ways as to how we would actually capture the data, although better minds than mine I hope come up with ways.
The problem is that to get a good read on arterial pressure you either need to do it the old fashioned way (occlude the artery and record that pressure, then slowly drop it until it's constantly flowing again - see [0]) - or you need to stick a cannula into an artery, as we do in ICUs, and measure pressure using a transducer.
Even technologies that stress their 'passivity' (see [1]) and try to capture this market use the old fashioned way. I don't see that changing anytime soon - you could try and somehow monitor the stretch of a small artery maybe using some variation of current o2 saturation sensors, coupled with advanced computer models of flow rate and variation in small arterioles, but that is a world away and would seem to me to be highly subject to variation/sensitivity.
My prediction is that this won't be possible until we are commonly implanting biometrics in people, but I guess we will wait and see!
[0] https://en.wikipedia.org/wiki/Korotkoff_sounds [1] http://www.visimobile.com/
Thanks for batting around the idea with me, and for the valuable references. I didn't know there was any other way to measure BP than the old-fashioned way.
http://www.racgp.org.au/download/documents/AFP/2011/November...
We know that most people can't even take their medication properly (many organ transplants fail because people don't comply with the medication regime, for example) so easier blood pressure monitoring would probably be useful. Especially if you combine it with something that can lower blood pressure.
http://www.nice.org.uk/guidance/cg127/chapter/Key-priorities...
> Diagnosing hypertension
> If the clinic blood pressure is 140/90 mmHg or higher, offer ambulatory blood pressure monitoring (ABPM) to confirm the diagnosis of hypertension. [new 2011]
> When using ABPM to confirm a diagnosis of hypertension, ensure that at least two measurements per hour are taken during the person's usual waking hours (for example, between 08:00 and 22:00).
> Use the average value of at least 14 measurements taken during the person's usual waking hours to confirm a diagnosis of hypertension. [new 2011]
> When using home blood pressure monitoring (HBPM) to confirm a diagnosis of hypertension, ensure that:
> for each blood pressure recording, two consecutive measurements are taken, at least 1 minute apart and with the person seated and
> blood pressure is recorded twice daily, ideally in the morning and evening and
> blood pressure recording continues for at least 4 days, ideally for 7 days.
> Discard the measurements taken on the first day and use the average value of all the remaining measurements to confirm a diagnosis of hypertension. [new 2011]
It's discussed in a journal article from earlier this year by a pathologist:
> panel profiling, which was introduced in the 1970s as a way of identifying early biochemical changes of disease in asymptomatic individuals, had been abandoned in the 1980s, not so much for the cost. It has long been realized that with multiparametric testing, approximately 5% of results will be false positives, i.e., test results outside the reference intervals, in otherwise normal subjects. This is due to the definition of reference intervals, as being values between the 2.5 and 97.5 percentile of a reference (normal) population. The high cost of investigating seemingly abnormal results in normal people, and the added anxiety of patients, has led to the complete replacement of such biochemical profiling with what is now known as “discrete testing”. In the latter, tests are performed by the testing laboratory, only if requested specifically by the physician.
http://www.degruyter.com/view/j/cclm.2015.53.issue-7/cclm-20...
If a lab result is outside the normal range and a patient has a reason for it to be outside the normal range, that's fine. If a patient has a deviation that is related to their presenting complaint, that's fine too. If a patient has an unexplained deviation which is not related to the presenting complaint, well, there's a 1 in 20 chance that the variation is statistical only. So you use your clinical judgement. is this a patient who requires outpatient follow-up and repeat, or is this an abberation?
Most people simply aren't smart or informed enough to understand things like "false positives".
This would be what I see as the fundamental flaw behind Theranos, even if their technology worked (works?) as promised: the idea that more data will always be better is sophomoric (and I select that word judiciously, considering the founder). Evidence-based medicine clearly shows that more data does not, in itself, lead to a better outcome.
Studies [1] show that weekly INR testing results in a 55% reduction in strokes, 35% reduction in major bleeds and 39% reduction in deaths.
[1] Henagen C. et al. Lancet 2006; 367:404-11
This is ridiculous. A lifetime politician accuses other clinical scientists and medical practitioners questioning Theranos' basic technology and its secrecy as political campaign? That's not how Science and Medicine work. Even that "a front-runner" statement is questionable. Theranos can not even releases its revenue number to be compared to LabCorp or Quest Dx.
> In the early 1990s, Mr. Holmes moved the family to Texas where he worked for energy companies, including Tenneco and Enron. (Mr. Holmes has since returned to public service and now works at the United States Agency for International Development.)
NOW that gets very interesting! Mr. Holmes [1] was found to be listed as officers in at least four Enron subsidiaries[2,3]. Guess that would be great lessons for some future entrepreneur. Conveniently such Enron experiences are not listed on USAID website [4].
[1] http://individual-contributors.insidegov.com/d/c/Christian-H...
[2] http://www.corporationwiki.com/Texas/Houston/christian-r-hol...
[3] http://www.ruf.rice.edu/~eesi/scs/Holmes.htm
[4] https://www.usaid.gov/who-we-are/organization/christian-holm...
Thanks!
Funny how that works. I'm just getting into the book Superforecasting: The Art and Science of Prediction by Tetlock and Gardner and came across this passage:
Galen is an extreme example but he is the sort of figure who pops up repeatedly in the history of medicine. They are men (always men) of strong convinction and profound trust in their own judgement. They embrace treaments, develop bold theories for why they work, denounce rivals as quacks and charlatans, and spread their insights with evangelical passion.
So even if Theranos is a complete flop, Holmes may still prove a groundbreaker in her hubris. Tetlock and Gardner sum up the problem by quoting Richard Feynman:
What medicine lacked was doubt. "Doubt is not a fearful thing," Feynman observed, "but a thing of very great value." It's what propels science forward.
Less so, I guess, visionary entrepreneurs.
"For a successful technology, reality must take precedence over public relations, for Nature cannot be fooled."
https://www.washingtonpost.com/news/wonk/wp/2015/12/02/inter...
I found General Mattis joining their board, after supporting them within the DoD over internal objections, to be particularly interesting.
99% of them are faves for someone saying how inspiring she is. How she breaks glass ceilings. How she's doing something significant. How the press just wants to build people up to then tear people down. How she should run for president. How her speeches were transformative. How she has vision. Her bio. Her story. Videos of her. Press puff pieces about her. Her face. Her.
I've never seen anyone on Twitter use faves in quite this way. It's not faves about anyone else's content or jokes. It's not faves about Theranos, either. It's all. about. her.
https://www.twitter.com/eholmes2003/favorites
#narcissism
I wonder how much of Theranos is a long-play effort to create a "brand" around Holmes?
Perhaps years later, long after Theranos is dust, she'll point to it as a huge success that made her into the billionaire she became.
I'm not sure that fanatics do science well, or handle other people's money that well either....
I know founders sometimes need to create a reality distortion field and sometimes act as if, but as a patient I would also expect transparency to understand exactly what the company is doing and if the tests are accurate.
Puffery and misdirection in a business whose key selling point is accuracy is a bit concerning.
Did I leave anyone out?
My mistake.. ..that role has been outsourced to Bangalore.
“The minute you have a backup plan, you've admitted you're not going to succeed.”
Elizabeth Holmes is a category filter on their News page.
The questions are easy to answer and wouldn't give away any trade secrets, but she pretty systematically refuses to give simple direct answers to very simply questions. If answering these simple questions, like how many tests they can run using their tech, would give away trade secrets then their tech isn't likely very interesting. The copy coming out of the company insists they are able to do the things they claim, but it doesn't appear they have any particularly commercial ready technology to go to market with.
Holmes is caught in a bit of a bind, she used her family's powerful connections to raise absurd amounts of money on nothing at all and now has to deliver or face the wrath of those same powerful connections. She's also managed to fill the board up with big names through her family connections who have absolutely no medical background at all (except for Dr. Foege) in an effort to give some kind of legitimacy.
Here's an example of her answering simple questions to get a feel:
https://www.youtube.com/watch?v=A8qgmGtRMsY
https://www.youtube.com/watch?v=MBs-oj7U-bo
Here's an example of how she answers things, (exact quote) "So we have developed hundreds of tests over the course of the last 12 years that can run on a tiny sample using proprietary Theranos technology..." The critical missing components to this statement:
a) To what accuracy compared to traditional tests?
b) All of the tests on one sample, or one test per nanotainer sample?
c) Are all of those tests current tests that Theranos would run on a sample? (R&D could be generated 10 tests a week, but 90% of those tests could be poor, or could not be clinically useful)
She then goes on about taking the data they've generated for their FDA submission and putting it into the public domain and being a leader in transparency. She goes on to talk about all the various technologies Theranos has developed, but it's only the nanotainer tube that's being tested and blah blah blah it's all very complicated and none of the answers clarify or complete any other answer - it's like getting a good image from a shattered mirror.
Simple yes/no answers turn into minutes of non-answers. This isn't difficult, but she makes it absolutely excruciating.
Here's an exceprt from her bio from theranos.com
"Theranos' breakthrough advancements have made it possible to quickly process the full range of laboratory tests from a few drops of blood - instead of numerous tubes - and at unprecedented low costs, and are now directly accessible to people and their physicians through Theranos Wellness Centers opening nationwide."
Except not a single part of this has been demonstrated to be true in any way.
Most blood tests, though, are about detecting whether levels of a substance are in a particular range - milligrams of cholesterol per deciliter of blood, mg glucose per deciliter, etc. Taking a much smaller sample is pretty much guaranteed to make the plus/minus error range larger, and capillary blood from a finger prick will have a greater percentage of contamination from intracellular fluid.
Even glucose meters you can use at home are much less accurate than glucose readings taken with a venous draw in a lab. In that case, the benefit to a diabetic of being able to do frequent home testing outweighs the loss of accuracy. If you're going to get work done by a lab, though, you are going to want it to be as accurate as possible, and in that scenario I don't see how a finger prick will be able to compare to a venous draw.
This seems a little unfair to Holmes. In this one paragraph, anonymous former employees paint Holmes as a megalomaniac -- e.g. she fires people "who pointed out problems" and lies about the existence of technology. She may very well be a megalomaniac, but these assertions should at least have vague anecdotes ("A former employee recalls a 2008 incident in which Holmes fired a senior engineer in a Reply-All email after he replied that he didn't think the machine could be finished on deadline."). The judgment of what is simply pointing out a problem is sometimes context dependent. And nothing else in the story mentions other proof that would affirm that Holmes is a power-freak when it comes to being the CEO. Yes, there are plenty of anecdotes of her being headstrong in negotiations and attempting projects and deals that went nowhere, but that's a different thing than being a vindictive charlatan among her own employees. The NYT sat down with her for a 2.5 hour interview and could have at least confronted her with this and given her a chance to deny it. In contrast, the WSJ, who couldn't score an interview, had actual anecdotes [0] (the hearsay of one of Theranos's chief engineers, who had claimed the technology was a fraud before committing suicide, and emails about fudging the FDA tests).
The parts about her pre-Theranos life were similar to the New Yorker's story from last year [1]...it sounds like she was the real deal in terms of being a passionate engineering student. It makes me wonder if she had spent at least a couple more years beefing up not just her engineering experience, but life experience, that some of the poor CEO decisions she's made would have been mitigated.
[0] http://www.wsj.com/articles/theranos-has-struggled-with-bloo...
[1] http://www.newyorker.com/magazine/2014/12/15/blood-simpler
I think that is a very astute observation. When you are in the top 0.01% of CEOs you don't have a lot of scrutiny. Bill Gates says that he got lucky with his success and that graduating is a much more sure path to success (http://www.nytimes.com/2015/06/04/upshot/bill-gates-college-...). If you do make mistakes or have a failure and you dropped out then that (for better or worse) is a focus and probably makes it more difficult to bounce back. She hasn't failed yet, but the fact that she didn't spend the extra year or two finishing her degree will make it more difficult if she does fail. And lets be honest. We all fail at least once or twice.
If she weren't so well connected or known I'd agree with you. But she isn't some unknown dropout who failed fast and hard trying to get into YC or bootstrapping in some random location in SF. Unless Theranos gets revealed as a giant fraud, I doubt she'll find it tough to find another position in the future.
The purpose of NYT article seems to be to message that while Holmes may get removed from the CEO, the shareholders are still hoping to retain the value.
I'm no fan of Theranos, but the more plausible explanation is that she's blue bood family w/ connections, and they're pulling those in because they can.
I don't accept as supported the assertion that influential accomplished people on your BOD means you're out to corruptly influence process (any more than general business).
Ms Holmes seems to be solid leader in the sense that she is well-connected, possesses salesmanship and communicates a clear vision. She has certainly been able to raise large funds.
Sure there might be hr problems but that is the case with any company and surely professional mid level management can be hired in to fix that.
Talk of double standard.