The point about needing a doctor's order to get a blood test seems pretty irrelevant to the rest of the situation. I don't know why they included it.
I'd love to get a simple blood test without needing to talk to my doctor (plenty of people would). I would not love to get a blood test misrepresenting its accuracy (nobody would).
The reason is the same as why you require higher standards of statistical evidence when you don't have a strictly defined hypothesis before an experiment: if you go looking for something in noisy data, you'll probably find it.
Lab tests have significant margins of error. Just by chance, if you go out and get a bunch of lab tests, you'll probably find something "wrong". Unless you're knowledgable about interpreting the results -- and unless you are a practicing medical doctor, you are highly unlikely to be knowledgable, even if you think you are -- this can/does lead to catastrophically bad outcomes.
(And now, for an ironic aside: the median HN user is extremely quick to attack valid science for the reason that "most results are wrong", while also complaining loudly when the medical establishment wants to restrict access to clinical tests with a large margin of error. Go figure.)
For things like STD tests it raises the barrier and cost of frequent testing. We need a more fine grained policy than all blood tests require a physician.
They don't. You can get cheap/free STD tests from non-physician providers. You can also buy STD tests at the drugstore, over the counter. But like it or not, anyone who collects biological samples from strangers' is going to require some training and licensing.
Moreover, the interpretation of an STD test is not as straightforward as you might think. False positive rates can be high for the cheaper tests, and there's natural variability in things like antibody titers. People also neglect that timing matters -- if you test too soon after infection, even the most sensitive tests won't work. Or they fixate on one particular scary illness (e.g. HIV), and neglect testing for others that are less well-known, but more common (e.g. Chlamydia). Some of these problems can be mitigated. Others can't.
Regardless, having someone trained to interpret tests is a good idea for just about everyone. Even the cheap/free/OTC tests come with that service, at a minimum. It's a bad idea to just allow people to pick and interpret their own tests, even for the "simple" ones, like STD tests.
There is another issue I've read about, which is that outside the context of a medical diagnosis, even a very accurate test would still be relatively unhelpful because it can be measuring natural variability. (E.g., testing some metric associated with prostate cancer in young men/women — prostate cancer only appears in older men, so testing young people is mostly useless.) Whereas if you're already potentially sick and go to a doctor, the relevant tests then have more predictive power.
In reality this doesn't mean much because I can order a blood test online and a doctor's approved receipt will be available in under a minute to take to a local lab. I doubt the doctor looked at anything except his bank account. And this process is legal in most US states.
I used to do this to supplement my doctor's own tests because of my own curiosity and concern. So I just paid for it myself without insurance. For example a standard panel of 26 common tests costs $55.
I don't get it. What is the average person going to do themselves with the results of a simple blood test?
Car analogy: is there any point in taking your car to a garage and having them look it over and just make a list of the status of common components on the car, without any (vehicle specific) interpretations? As in "you have 5/16 inch wear difference between the front left and right brake rotors, the steering toe-in is 1.3 degrees, and the alternator is providing 13.2 volts".
A better question is would you drive a car without a working gas gauge?
Blood tests are flagged as abnormal if they exceed the 95% confidence interval. So there is a possibility of it happening by chance. Or you may get some abnormality due to minor issues like a recent cold or injury. But then you just need to start a conversation with your doctor to get clarity.
Did you know your kidney health could be down to 10-20% of capacity and you would not even feel a thing wrong? And something happened to me in 2 intervening years of tests for that exact scenario to happen. I doubt most people have tested anything other than their cholesterol and BP in the last two years. If anything, we should be checking our body health more than our car because we can always replace our car.
This was a law passed in Arizona that likely doesn't happen without Theranos pushing for it. It certainly seems relevant that a company making illegitimate claims about their product wants to bypass the scrutiny of medical professionals.
The need for a doctor is less about getting your blood work down and more about going over the results and analyzing them based on your medical history and general profile.
You can pay to get blood work done even without a doctor in most cases but there is actually very little use for it if all you going to get is some standardized report without any good way of actually analyzing and no i don't thin theranos had a good system in place to bring that to the masses and this isn't something that needs to be brought to the masses in the first place.
Instead of finding a way to allow you to get your blood tested in the same manner as you would develop film 15 years ago why not work on making doctors more accessible?
Doctors and trains hemotologists is what you need scalability was never an issue.
Agreed. I thought this quote from the article was pretty lame:
> Because once the patient has those test results, more likely than not, they're going to need a doctor's opinion to decipher them and to know what those results mean. So why not keep the doctor involved from the beginning so that, first of all, there is a logic for getting the blood test, and then there's an expert opinion there when the test results arrive to help you interpret them.
I call BS on that. Many, if not most, tests would NOT need any doctor involved if the test came back normal, which in the majority of cases, it does. Heck, when I go to my doctor NOW and have to get a test, if everything is normal I just get a phone call: "Yep, everything was normal." Explain again why a doctor needs to be involved in that process?
As another example, look at STD tests. Anyone can walk into one of thousands of clinics around the country to get a suite of STD tests, no doctor required, and only if a test comes back positive would you need to see a doctor. So why is this so different from other types of tests?
If you got every blood test done you would no question get several false positives. If 1,000,000 people got every blood test possible they would on average have worse Heath outcomes than a control ground who got zero tests. This is who of he reasons mass screenings for conditions are often a bad idea.
The problem with false positives is they often show up because your body chemistry is X not because the test failed. So, subsequent screenings are often more invasive and involve risks. (radiation, being cut open etc.)
Blood tests vary from reasonably simple to extremely complex, extremely reliable to extremely variable and requiring no further action (as in your case) to requiring multiple possible further decisions.
Understanding the results of multiple medical blood tests requires some knowledge of multiple subjects including biochemistry, chemical pathology, microbiology and immunology.
There's also the question of what to do next - do you repeat the test, get additional blood tests, get other tests (such as radiology or biopsies) and most critically do you actually have a diagnosis and do you need treatment? (If so, what?)
Then there's the issue of false positives and false negatives which most people get wrong (especially if you're in a low prevalence population).
The doctor needs to be involved because there's no guarantee that things will be normal.
Also depending on the test you may or may not understand what "normal" means.
Here's a quick test - These are some of the most commonly ordered blood tests: Which of these tests would you be happy to interpret yourself?:
Lab test, or medical practice in general, is a well protected industry here in States. The public wasn't educated well enough to understand lab tests at all so that professional opinion IS REQUIRED to understand your own health.
I might be over cynical here, but I blame that both medical education and health care industry are restricted and protected to cause a very inefficient public health system in US. Thus normal people without a MD has no clue to judge good product vs bad product. In the case of Theranos, I don't think most of understand what's going on with the test. How the test works, how to judge whether it's effective, how to compare pros and cons between different products. We have no idea. I doubt whether the report himself understands the real deal behind the scene, or even investors of Theranos understands it.
I'm pretty sure it wasn't the "doctors get to be gatekeepers" problem that held back Theranos here. Rather, it was the "they don't have an actual working finger-prick test and have avoided numerous cheap ways to prove they have one" problem.
In contrast, 23andme can legitimately claim to have been held up in that respect. They did have a working product, which correctly identified the patient's genes, and correctly reported the state of the literature on each gene; no one claimed otherwise. It's just that the combination of those two services counts as a medical device under current law, and they didn't get regulatory approval first.
I tend to agree with you on Theranos. I wasn't trying to say that Theranos is doomed from the beginning because they are about to disrupt a well protected industry. Instead, I feel the problem is that we as general public are not educated well enough to make a reasonable judge on whether Theranos is actually working.
If medicine was actually simple enough for a layperson to understand without training, I'd expect to hear more than a few medical students saying, "it's all just a hazing ritual, biology is actually trivial." That is a staggeringly large number of conspirators to have successfully kept a secret.
I order blood tests from my doctor, a couple days later I get the results with two sentences, probably pre selected from the app they use. The doctor adds no value, but creates costs.
This is extremely simplistic logic. (I'm a physician).
Blood tests vary from very simple to extremely complex, extremely reliable to extremely variable and requiring no further action (as in your case) to requiring multiple possible further decisions.
Understanding the results of multiple medical blood tests requires some knowledge of multiple subjects including biochemistry, chemical pathology, microbiology and immunology.
There's also the question of what to do next - do you repeat the test, get additional blood tests, get other tests (such as radiology or biopsies) and most critically do you actually have a diagnosis and do you need treatment? (If so, what?)
Then there's the issue of false positives and false negatives which most people get wrong (especially if you're in a low prevalence population).
I worked for a medical lab and a large part of my job was double checking that the doc selected the correct macro.
For some stuff a large amount of interpretation is needed, for a simple PCR test it is not needed 99.99% of the time. The possible interpretations have already been entered and the doc selects one based on the result. It could be automated, but against the law since the doc has to do it. There is that 0.01% chance that something else is going on and the doc will pick up on it when seeing other results/patient history and will end up writing additional interpretation or something very different.
However, that result is rarely seen by a patient. It goes back to the treating physician who then reads it and interprets it himself and uses to guide treatment.
and nbsp walking to the ProPublica podcast I'm Charlie Orenstein and I cover healthcare here at ProPublica
today we're gonna be talking about laboratory testing
it's no secret to many that lab testing has been caught in the dark ages of medicine
or you have to go to your doctor to get a prescription for a lab test
and then your doctor gets the results of the lab test if you're lucky will share with you
and then you'll be back to going to your doctor again if you need a follow up
a company called their in house aim to change that
founded in two thousand and three by Elisabeth homes
a nineteen year old drop out of Stanford University this company and to really shake up laboratory testing
it received fawning coverage from many mainstream media outlets including The New York Times
but John Kerry Roo a reporter at the Wall Street journal took a more critical look at their in house
and found that behind this glossy surface there were a lot of questions about both its effectiveness and the science that underlie its main products
John is joining us here on the podcast John Markham hi thanks for having so how did you decide to take a look at their house
well I had read Ken Auletta as profile of Elizabeth homes in the New Yorker in which I think came out in December of two thousand fourteen and
I found it interesting there were some brief critical %HESITATION sections in there that raised questions for me but I don't think all that much more of it and then as the calendar year turned to %HESITATION two thousand fifteen a couple weeks later mid two thousand fifteen I got a tip from someone not a primary source who had any primary information but someone who is a relating to me
some you know third hand information that that things might not be exactly as they seemed at this company thoroughness
so it's interesting because I think a number of reporters got tips along the way and and you were the one to pursue them I personally heard from somebody who said that his lab results didn't match the lab results he got from a different lab so it doesn't seem like this was a huge secret that there were questions out
right and shortly after I began looking into the company in and looking into this tip a Stanford on a medical school professor I believe %HESITATION put out a critical opinion piece in the journal of the American medical association
and he didn't really have any any information other than the say this is a company that was
making very bold statements about its breakthroughs in the science of laboratory testing saying that it could test for a number of conditions off just a drop of blood from the finger and yet it hadn't really done what you usually do in medicine which is a peer review
and he was questioning %HESITATION this new trend of making all these assertions about what you've invented without really proving it and having it vetted by your peers and then there was another %HESITATION professor in Toronto I believe a couple weeks or couple months later who who came out with a critical medical journal and I editorial as well so people are beginning to speak out in the scientific community as I was doing my reporting
so let's just take a step back and put the science aside for a second what is the hope of fairness what it promised people
so the the fair knows invention as Elizabeth homes are
you know announced it in magazines and at conferences was that %HESITATION with a tiny drop of blood from a finger with the lancet
they could run the full range of laboratory tests and get you back results on all these tests within hours
and at a low cost to the latter part is true they charge very low prices and then when you look at the assertion that they can do the full range you you ask laboratory experts what that means and they say can mean anywhere from several hundred to several thousand tests
so the claim was quite bold in this hadn't been done before from just a drop of blood being able to run the full gamut of tests and get results back to the patient's very quickly %HESITATION it did sound like a real scientific breakthrough and third for listeners who may not be aware of what is it usually take as far as blood to run that gamut of test what weirdest blood come from and how much blood is needed
well if you get tested for say a a comprehensive metabolic panel which is a typical panel that you might not get a prescription for your doctor for which is about a half dozen tests
you'll go to request or a lab Corp or a hospital lab in they will draw your blood with a needle odd that they put in your arm and they'll draw about five tubes of blood so quite a bit of blood is typically %HESITATION required to to run you know half dozen tests
so Liz with homes was incredibly successful I think getting it hundreds of millions of dollars four hundred million dollars %HESITATION of invest more money and more than us more than that so that value the company at nine billion dollars or so
yeah we we went back and found some %HESITATION some regular
for filings and were able to calculate that they raised at least seven hundred and fifty million dollars most of it more than six hundred million dollars was raised in two thousand fourteen and that last fundraising round valued the company at about nine billion dollars
which is a a huge of valuation that that's our moral less what quest and LabCorp are each valued at and these companies have been around for a long time and they have a huge revenues in huge profits
are in this laboratory upstart that was founded by a college drop out ten years ago suddenly valued at at the
the same valuation as those two huge companies alright let's stop there because I think listeners Arabic %HESITATION why like how did this unicorn
get so much money what did people see it
that isn't clear what people saw in it other than %HESITATION Elizabeth homes as pitch
that she had made this scientific breakthrough is not clear because I've heard that and and pretty much ascertained during my reporting that the company did not offer really any information
about the science and about how the technology works about how it's
laboratory %HESITATION instrument worked
or about its financials so are investors who were putting up this money were for the most part going in blind
but at a star studded board right
they did they had %HESITATION Henry Kissinger
and now George Shultz and Sam Nunn and %HESITATION
Phil frets they had a bunch of older statesman some exit some retired military commanders
it was a %HESITATION heavy duty board a lot of big names
in %HESITATION the military and and former cabinet members
%HESITATION incident seemed impressive at first glance
so your first piece ran last year and you began raising questions what were the key questions that you found
so the first thing was to
look at whether they were or were not running the full range of laboratory tests
on other proprietary technology
and after a lot of reporting in talking to former employees who were in a position to know exactly what the reality of that was
I was able to determine dead of the more than two hundred and forty blood tests that they offered consumers at their blood draw centers in Walgreens stores
that at the very most at the end of two thousand fourteen fifteen of them were run on their
pride Terry lab instrument which by the way they called the Edison after the inventor Thomas Edison pretty clever out why does it matter though that who cares which instrument that tests were run
well
if you're asserting that you that you made a scientific breakthrough that it enables you
to run the full range of laboratory tests off just
a drop of blood and it turns out that you can only do fifteen tests then
you're you're probably hyping where you are in and your ability and so then the question arises whether you've told the truth to investors whether you've told the truth to the public
but then there's the the other issue that I discussed in my first piece which was published in October which is what whether or not
the testing for those fifteen tests and and that the testing for all the other test
was accurate and produced good results and and I had ex employees telling me
that %HESITATION they questioned the accuracy of the Edison machine and that their endless was also doing things like diluting small blood samples in order to create a bigger volume to run them on commercial analyzers
that also created problems with accuracy
and I would travel to Arizona and talk to patients and doctors there and came up with anecdotal evidence of
a test that didn't seem to square with comparative tests done at other laboratories and so all of that made me realize that it wasn't just about potentially company that it over hyped
I can forgive Watson for not understanding proper nouns, but not for confusing it's and its (given plenty of context).
The insertion of %HESITATION to denote pauses of speech is an unexpected delight.
A long time ago, as work-study, I transcribed several audio recordings of descendants of the first non-Native settlers of Santa Clara Valley. There were many ellipses in my transcriptions, and I wonder if future researchers will question if they represent hesitation, ums or uhs, or periods where the recording was unintelligible.
> ...Theranos also played a role in the passage of an Arizona law that allows people to get blood tests without a doctor’s order. Carreyrou: That was controversial, because there are many in the medical profession [...] who say, "Well, how is that progress?" [...] more likely than not, they're going to need a doctor's opinion to decipher them.
This is a good point. Diabetics usually go to the doctor 1-3 times a day to have bloodwork done. Surprisingly, despite how open the medical field is from a regulatory, technological and informational standpoint we have done almost nothing to combat the complexity of tests taken regularly by most of the population. I would have overlooked this and I am glad the author brought this up, maybe it would be possible for users to be trained on some of the newer technology being rolled out in the medical field like the Facsimile Machine (often called FAX or sometimes by the synecdoche XeroX) to communicate with highly skilled professionals, to interpret the data. It is likely that every person would fall outside of a standard bell curve so it would be impossible to teach anyone how to interpret the test, but we could set our sites on leveraging FAX in the future.
> How a Reporter Pierced the Hype ...
This is great reporting and a perfectionist usecase for new media. The journalist was able to quickly go on wikipedia to create a paragraph of color, and then link to the interview so that readers would be able to immeadiately hear how this reporter had broken the hype machine over a 20 minute interview at an offsite location. Maybe, unlike everyone else, you actualy don't have 20 minutes to listen to this interview, perfect contingency here 3 bullet points.
Much like the author, I skipped around through the clip pulling random qoutes, the reporter is asked:
A number of reports got tips and yoiu were the one to purse this. Other reporters got tips as well but you pursued this?
Not knowing much about how the Peer review system, I called my colleague G. oog LeSearch Barr who confirmed peer review is basically the only important thing about conducting science, and the system is renowned for it's perfection.
The reporter did say 2 people in the community had spoken out, which to be fair, is quite reasonable. He was pragmatic about waiting to fully engage with the story until, and I am paraphrasing but editorializing much less than one would think:
The 9 Billion in 2014 is a big valuation.
How did this unicorn get money?
What people saw other than Holme's pitch isn't clear. I have heard the company didn't offer anything about how the technology worked.
After a lot of reporting, I talked to a lot of employees who were in a position to know, I determined that 350 blood samples 15 were run on their machine.
---
Now it is important to realize, Theranos didn't use the AMA standard bootstrap medical breakthrough CDN and while not much is known about the internals of the company, it is believed they didn't spin up a AWS Full Scale Research Labratory, they may have not even considered using GO.
Now, all that can be forgiven, right? But it is such a shame they didn't just roll this out overnight. It is fucking trivial to build this, you can just use Crimson on Beaker for the front arm and then persist your regularatory data to the USFDADEAFBI?SOMESENATOR.gov/api and get approval.
750 million dollars to basically build a crud app seems like a lot of investment. Obviously Holmes, much like her predecessor Alexander the great, had to hire Michael R. Taylor the Head of the FDA to follow her around saying "You are just a human, only a mortal". Notably, this actually should have helped Theranos as Taylor is a renowned scientist who has won a nobel peace prize. He graduated with a degree in political science doing pretty serious research as a staff attorney at the FDA, and working with the private firm that represents the worlds biggest provider of open source seeds, Monsanto.
As an aside, Taylor is a New York Times best selling author for his riveting 1988 article entitled "The De Minimis Interpretation of the Delaney Clause: Legal and Policy Rationale", where his interpretation of a 1958 law about the ppm of chemicals, is considered truly breathtaking when read.
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She may not succeed, she may (we DO NOT KNOW) have cheated, but what fucking world do we live in if we can preach "Fail Fast" to the 40th uberPetBNBPariscopeAOLtimewarnerTwitterBlockchain-#NOBACKDOOR-google-earth-for-mars-but-with-instagram-filters
and tell the people who are fucking trying to push forward the most highly regulated industry forward, which requires not only innovation but capex, and a strong board (Kissinger/etc are there to lobby because you CAN"T EVEN COMPETE without someone connected, much less succeed).
So you can question her ethics, her strategy, etc, and if she committed fraud I certainly wouldn't defend that, but if it ends up she took a shot at something big and missed, I vote we let the next guy or girl take a similar shot.
I'd love to get a simple blood test without needing to talk to my doctor (plenty of people would). I would not love to get a blood test misrepresenting its accuracy (nobody would).