OK downvoters convinced me I am wrong having 10s of billions of $ at stake obviously is unlikely to incentivise parties on either side to finance studies that would be favorable to their position and to spend their PR budgets on having those studies highlighted in the press.
The article claims the researchers are independent and external. Do you believe the nyt or the researchers are lying? Obviously Theranos has an interest in the outcome of these tests, but I think medical researchers would applaud less expensive and accurate tests.
So here's the thing - people like to say "This doesn't look like a big enough study..." but you never see them say what would be.
Basically: How do you justify your belief that their sample size is to small?
There are calculations to do this. 60 patients is, while small, pretty standard for a study like this, and decently powered. The authors also used the appropriate techniques to deal with small numbers in particular strata when they were controlling for the variables they mention.
for 5% confidence interval with 80% confidence level you would need 164. For 1% confidence interval with 95% confidence level 9604. For 1% confidence interval with 99% confidence level 16641.
Meta question: to what extent is the present-day "tech crash" or tech funding crunch scare a reaction against this particular high profile implosion vs. a more general sentiment?
We've seen huge investments over the past five years into start-ups, apps, services, etc., that VCs hoped would turn into the next Uber/Facebook/Snapchat/Twitter/whatever. Now we're seeing VCs and the economy separating the wheat from the chaff. Furthermore, we're finding that even the Snapchats and Twitters may not be as great of companies they were hoped to be. Rational thinking is simply replacing irrational exuberance, and I don't think the blame (credit?) can be placed on any one company.
Not at all. It's just that the investors here did a piss-poor job of looking at the company pre-investment. Lots of herd mentality and external validation going on rather than common sense and some skepticism. The funding crash seems to be mostly based on less than stellar returns for previous funds now at the end of their life-cycles.
That makes it a lot harder to get LPs to pitch in. Still, even today there is a glut of money chasing far too little viable start-ups so as far as I can see if you have a solid proposition it should not be hard to find funding. If you are a bs artist then it may get a little harder, and that's a good thing (especially for those entrepreneurs that do have something to offer).
>On Thursday, Theranos sent a letter to the journal, hoping to stop it from publishing the paper.
Yeah, so these are the kind of people I want to trust with my personal health?
The problem isn't the tech. The tech is close enough to accurate to be massively profitable. The problem is their reaction to criticism. It erodes any and all trust in the product.
When you are dealing with a company built upon measurement of the invisible, trust is the most valuable commodity. I need to trust that the numbers from your machine are reported as true.
I need to trust that you aren't lying and covering up data to make a buck...
How do you know? It says that apparently the methodology could be flawed due to things in the blood clustering together
>you aren't lying and covering up data
What? From reading, admittedly only, this article here, it sounds at least reasonable to complain given the hugely negative press when it is also true that "the study authors made no attempt to find out which measurements were right". So if I understand this correctly, the new method showed different results from the old method, but nothing was done to show which was right, and it was clearly insinuated the new one was wrong. I would complain, too. But perhaps you know more about this incident.
>How do you know? It says that apparently the methodology could be flawed due to things in the blood clustering together
From the reported independent results.
+-5% compared to Quest and LabCorp at a fraction of the cost is good enough to make a profit.
>It sounds at least reasonable to complain
It makes sense to complain in Silicon Valley...
But it makes you look like a slimeball trying to cover your ass in the medical/scientific industry.
Industrial science is different than tech. In tech, if it works, it works, and nobody really cares how. In fact, it is in your best interest to hide how you did it, because that is your IP.
In industrial science, if it works, but you fight people trying to open the black box, it makes you look like you're faking data.
>>The problem isn't the tech
>How do you know? It says that apparently the methodology could be flawed due to things in the blood clustering together
kmonda, your statement requires some very important clarifications
1) your phrasing implies that there was a flaw in the methodology of the journal article rather than specifically noting that Theranos asserted there to be flawed methodology (A claim which other, independent, experts interviewed by the NYT did not agree with)
2) The blood clumping comment is, similarly, not an accurate representation of the article. The Dr. who noted the potential blood clustering issue was not noting it as a problem with the study methodology, he was noting it as a problem with Theranos' technology. This would contribute to error in Theranos' measurements, and the shift seen in the study. It would not contribute to error in the study itself. Theranos' assertion of error was about the vein blood draw causing error in the Theranos readings.
Further, the same Dr. whos words you are implying damages the credibility of the study is, instead, quite blunt about his opinion of Theranos
>“This represents just another effort for a failing company to cover up bad press for a technology that is not ready for prime time,” Dr. Frederick L. Kiechle, medical director for clinical pathology at Memorial Healthcare System in Hollywood, Fla., said about Theranos’s letter to the journal.
>Dr. Kiechle said it was known that cells in blood “tend to clump together and travel in groups,” so the tiny amount collected from a finger prick might not be representative.
EDIT: in the interest of transparency, I edited one sentence of this for clarity.
> Except that the WSJ forgot to mention that the research determined the incumbent results were just as irregular.
That's too reductive.
The WSJ cannot "forget to mention" a manuscript that wasn't published when their original articles came out.
The manuscript in question, an observational study, shows that Theranos has higher variation than standard labs for some tests, and that those tests are those that someone familiar with the field might suspect that a finger prick might have higher variation (e.g., lymphocytes).
The power of this manuscript is limited (in part because of Theranos not actively participating in peer-reviewed science like it's peers), but at a high level, it would hint that a physician sending a patient out for some particular labs would be wise to apply extra scrutiny to those lab values if the testing was by Theranos.
That's a great question but a bit difficult to answer.
On one hand, it's possible that they're just too big to fail, considering the massive amount of capital they've raised and all of the vested interests put into the company. On the other hand, Enron comes to mind, which did end up failing and was fairly huge as well.
If they can demonstrate -- and it's past time to do so -- from independent external researchers that their tests are similarly accurate to current standards but cost less and are less invasive, there will be a big market for that.
I suspect that it's momentum burning off their cash on hand. Who knows what their burn rate is, but could anyone ever give them more venture funding or a customer contract?
> but could anyone ever give them more venture funding or a customer contract?
Chances of that are slim to none, they are damaged goods at this point. A number of existing customers has already cut ties to avoid further association and any future would-be investors would be very wary of putting more money in without iron-clad proof the technology is solid.
If some of the tests consistently err towards a false positive but are less invasive and cost 80% less, that sounds like an acceptable trade-off for those tests. The patients with abnormal results would have to follow up with a different test, but the majority would save a lot of money.
One of the worst results you can have from a medical device is a test result that is wrong, but looks correct. A wrong result that is clearly wrong, or is on the border between good/bad will be re-run either manually by the lab technician reviewing the day's results, or automatically if the instrument supports automatic retesting.
However a result that is wrong, but looks correct does not set off any alarm bells. You'd better hope that the physician requested a battery of tests and in correlating the results, sees the outlier. Otherwise you're potentially screwed.
In running tests on actual people, saving money comes far behind the overriding concerns around quality of results.
To clarify, by "false positive" I mean showing abnormal results when it shouldn't. For example, if the cheap test is usually accurate, but when it's wrong it erroneously shows dangerously high cholesterol, then a more expensive but more accurate follow up test can compensate. But I agree that if the test has a lot of false negatives (showing normal levels when they're actually abnormal), it shouldn't be used at all.
What prompted my comment was, "While most of the results were similar for the three labs, 12.2 percent of the measurements reported by Theranos were outside the expected normal range for healthy people, compared with 7.5 percent for Quest and 8.3 percent for LabCorp."
To me that sounds like at least some of the tests may be erring towards false positives. More research needed.
For most blood assays, there is no such thing as a positive or negative. The normal range for cholesterol, for instance, has both an upper or lower limit. This leads me to believe that the Theranos tests are just less precise overall, which makes it hard to justify their value even at an 80% discount.
This logic is not necessarily true. The tests are inherently probabilistic. Medical professionals must use the impact of a False positive or negative and the baysean probability of a disease given their test results to determine the best thresholds for patients. False positives can still be very harmful to patients (surgery, medication, lifestyle changes, etc) so they must be taken into account as well.
One classic example is a pregnancy test. You're going to find out eventually, and the impact of a false positive is huge, so the test errs toward false negatives instead of false positives.
> False positives can still be very harmful to patients (surgery, medication, lifestyle changes, etc) so they must be taken into account as well.
Well yes, I wasn't suggesting jumping into treatment before verifying with the expensive, higher specificity test.
Even with pregnancy, the impact of a false positive isn't huge when the next step is just to take another test - the same test that would've been done anyway if the first one wasn't available.
Though the potential savings probably aren't great with pregnancy tests because they're already cheap, and I'd imagine the overall incidence for people taking the test is pretty high.
Can anyone please enlighten us on Elizabeth Holmes's qualifications (formal or informal) for inventing blood screening technology? E.g., is she known for having won science competitions as a child? Or for tinkering around with blood screening technology in a garage as a teenager? Etc.?
“There’s actually pretty widespread variability in these clinical measures, even between the reference labs,” said Eric Schadt, chairman of genetics and genomic sciences at the Icahn School and an author of the report. “But Theranos was more outside of range and outside of range in ways that would impact clinical decision-making.”
I am the only person who thinks the entire idea of Theranos is nuts? It's far more painful to take blood from a finger than from the MCV in your cubital fossa (arm). The fingertips are some of the most highly innervated structures in our body (probably second to the sex organs). Then you have to go around touching things all day with a band-aid on your fingertips, while you would immediately forget about the band-aid on your arm.
The pain associated with a finger prick is basically constant. The pain associated with a veinous blood draw depends heavily on the patient and the skill of the phlebotomist. I can see how someone with hard to locate veins and one or two bad experiences would prefer the finger prick.
I would think that patients would probably prefer a /choice/ in that matter. Particularly those of us who have easier to draw from arm veins or those of us who mostly work with their fingertips (not just those operating keyboards; many professionals fit this category).
The pain in fingertips is usually associated with a blood draw from the pad of the fingertip. If you prick the side of the fingertip, the pain is greatly lessened for most people. YMMV, but generally true.
> Were personal computers replacing mainframes nuts?
Personal computers never replaced mainframes. Personal computers replaced minicomputers and workstations.
The difference is meaningful, even in this context: Minicomputers and workstations were high-end systems dedicated to things like relatively small-scale file storage, graphics processing, network tasks (servers, routers), and other workloads which required neither high throughput nor long up-times. They mainly required more RAM, CPU, and, sometimes, specialized hardware than it was feasible to put on a home system of the era.
Mainframes, on the other hand, had become specialized as high-throughput high-availability systems, running large databases and supporting dozens to hundreds of users at a time, for years on end. They'd grown entire specialized architectures dedicated to handling that kind of workload, and were only getting moreso as time went on.
My point is, if Theranos is the PC, it's only going to replace some aspects of the market it's moving into, and, from this article, it might not even do that. It's just too difficult to play catch-up with the extremely specialized realms, even if you have technology which is an 80% solution for 90% of the problems.
The main (claimed) innovation of Theranos was not just about the location of the blood draw, it's about quantity.
If you could really replace 10's of mls blood draws from the arm with a few drops (< 1 ml) drawn from the fingertip with no loss of clinically usable information, it would actually be a major breakthrough. There are distressingly large number of patients in hospitals requiring once a day (or even more frequent) blood draws to maintain correct treatment. The volume of blood and availability of veins and pain threshold can become actual, serious problems very quickly. This is doubly true in children.
If such tests were somehow found, they'll be noble-prize worthy scientific breakthroughs. Somehow Theranos is not giving off that vibe sadly.
My mom was extremely sick with an autoimmune disorder about 10 years ago. She went to the hospital frequently (both inpatient, outpatient, and for scheduled appointments) constant blood draws -- a dozen vials at a time. The nurse once joked that she wish she had some juice and cookies to to her. Cheaper, more frequent testing on smaller volumes of blood would be fantastic.
Taking a vial of blood prior to a finger prick blood test could dramatically alter results. Further, when the baseline (i.e. other labs) also have varying results, its fair to call into question the whole study.
Although I have my doubts Theranos blood tests are as acurate, I feel the study was pretty flawed.
>Taking a vial of blood prior to a finger prick blood test could dramatically alter results.
Could you elaborate on why? My expertise is limited to an EMT certification that expired half a decade ago, but isn't obvious to me why this would be the case.
Blood is constantly circulating, and even a veinous blood drawn doesn't remove an appreciable amount of blood compared to the total flow.
Besides a plethora of things that can occur[1], the main issue is a combination a pain response and a foreign object entering the skin.
When a you stick a needle in a persons arm you often trigger a flight-or-flight repsponse. It's actually fairly similar if you prick their finger. The problem with this study is that one was done after or before the other. It depends what you look for, but for example white blood count (which was tested) would/should change subtly after a blood draw.
The amount can vary (or not vary) depending on the person. For example, when I get my blood drawn my arm swells, it's not actually that I am allergic, but my body reacts in said way.
Regardless, my only comment was that the study seemed to be on somewhat shaky footing.
The vial of blood was only taken before the finger prick in the morning testing, in the afternoon testing the vial of blood was taken after the finger prick.
While it would have been nice to have them mix up the before/after scenarios between morning/afternoon it would be interesting to see if this has any effect in the raw data. I would guess it would have little effect as the volume of blood in a vial is still relatively trivial.
> Taking a vial of blood prior to a finger prick blood test could dramatically alter results.
Interesting. What mechanism or phenomenon are you proposing would be happening? Why do you think sampling order has more influence than the sample method (venipuncture v. finger prick)?
> Further, when the baseline (i.e. other labs) also have varying results, its fair to call into question the whole study.
Why? That's an expected outcome when dealing with multiple testing labs.
Every time I've had blood drawn it has taken several minutes and required a number of vials; if order was important it seems that it would be affecting the results of conventional blood testing. For me at least, the actual drawing of the blood is anti-climactic and I experience the most anxiety (with it's concomitant physiological reactions) in advance of the blood being drawn at all. Consequentially, it seems likely that the order doesn't matter significantly.
Furthermore, it's hard to imagine how results could be dramatically altered. How would having a previous finger prick blood test for say glucose level, cholesterol, triglycerides, blood count (CBC), calcium levels, blood urea levels, or the presence of antibodies possibly change the results of a subsequent test?
According to the WSJ article, a former Theranos employee has claimed that the commercial Theranos lab routinely diluted fingerstick blood samples and tested them using conventional machines from other manufacturers.
If true, this raises two questions in my mind:
1. Were the non-Theranos machines approved for testing diluted blood samples? The technology may be approved only for blood samples with normal concentration.
2. Were the non-Theranos machines qualified to test blood samples collected by any method? Some researchers think that capillary blood collected with a fingerstick may be too contaminated to produce accurate results.
In other words, was Theranos negligent with respect to federal regulations for use of these machines? Someone with clinical lab experience may want to weigh in.
So on that first paragraph, are they implying that the journal should have provided Theranos with a copy of the manuscript for review and comment? Maybe I'm not reading that charitably, but that's not how the system works, and I don't think scolding the journal (page 3) over manuscript decisions is an appropriate response.
The second paragraph is strikes me as a bit rich considering the reputation Theranos has for secrecy. As best I can tell, they still haven't published the more detailed information on their technology that they promised when the WSJ first broke the story?
Were I the editor, I think my response might be along the lines of "you raise some excellent points, and so we invite you to submit a research manuscript for accelerated review".
I have been following the Theranos articles in the Wall Street Journal closely. (I’m not a scientist and have no experience working in a clinical lab, so my opinions are those of an interested observer.)
My opinion is that Theranos should still be a small biotech company operating in R&D mode. They had no business going to market with a methodology and a product that were unproven and entirely hidden from scientific peer review. After the dust settles and they reorganize, that’s probably what will happen. Theranos should also allow their investors to pull out without any consequences.
Just to clarify, the testing device they claim to have invented is proprietary and they have every right to protect their IP.
By calling out the lack of peer review, I'm referring to the science behind the use of fingerstick sampling. When you extract blood from a vein with a sterile needle, the blood is uncontaminated. When you stab someone’s finger with a blade or sharp pin, presumably you have lacerated hundreds or thousands of capillaries. The blood that emerges is contaminated by tissues inside the finger and by oils and bacteria on the surface of the finger.
It’s possible to do simple tests like iron level with this blood and get accurate results. More complicated tests are another matter, and require scientific investigation.
Theranos doesn't have anything behind it - this company needs to go away and return its money to its investors. A single drop of blood is far too little to provide an accurate representation of your own blood components, the blood that's gathered from a fingerprick might end up containing a much higher or much lower concentration of 'x' than the rest of your blood. It's why traditional blood tests gather much larger amounts of blood - to increase the sample size.
Theranos executives also said that taking a big draw of blood from a vein immediately before a finger prick...affected the finger prick samples in a way that made it difficult to return a reading.
Is this so? I don't see how one could affect the other.
Sorry to rant, but I'm sure I'm not the only person who is getting sick of seeing these articles about Theranos. They essentially all say the same thing, and have a picture of Holmes at the top standing next to an unidentified piece of lab equipment that looks like it was just unpacked.
I suppose they are popular due to some combination of schadenfreude and the morbid fascination that comes from watching a slow motion train wreck. But I find these articles empty of anything remotely interesting let alone any edifying content. They are just a monthly sign post for the accumulation of disparaging comments about Theranos.
62 comments
[ 3.8 ms ] story [ 145 ms ] threadBasically: How do you justify your belief that their sample size is to small?
There are calculations to do this. 60 patients is, while small, pretty standard for a study like this, and decently powered. The authors also used the appropriate techniques to deal with small numbers in particular strata when they were controlling for the variables they mention.
That makes it a lot harder to get LPs to pitch in. Still, even today there is a glut of money chasing far too little viable start-ups so as far as I can see if you have a solid proposition it should not be hard to find funding. If you are a bs artist then it may get a little harder, and that's a good thing (especially for those entrepreneurs that do have something to offer).
Yeah, so these are the kind of people I want to trust with my personal health?
The problem isn't the tech. The tech is close enough to accurate to be massively profitable. The problem is their reaction to criticism. It erodes any and all trust in the product.
When you are dealing with a company built upon measurement of the invisible, trust is the most valuable commodity. I need to trust that the numbers from your machine are reported as true.
I need to trust that you aren't lying and covering up data to make a buck...
How do you know? It says that apparently the methodology could be flawed due to things in the blood clustering together
>you aren't lying and covering up data
What? From reading, admittedly only, this article here, it sounds at least reasonable to complain given the hugely negative press when it is also true that "the study authors made no attempt to find out which measurements were right". So if I understand this correctly, the new method showed different results from the old method, but nothing was done to show which was right, and it was clearly insinuated the new one was wrong. I would complain, too. But perhaps you know more about this incident.
From the reported independent results.
+-5% compared to Quest and LabCorp at a fraction of the cost is good enough to make a profit.
>It sounds at least reasonable to complain
It makes sense to complain in Silicon Valley...
But it makes you look like a slimeball trying to cover your ass in the medical/scientific industry.
Industrial science is different than tech. In tech, if it works, it works, and nobody really cares how. In fact, it is in your best interest to hide how you did it, because that is your IP.
In industrial science, if it works, but you fight people trying to open the black box, it makes you look like you're faking data.
kmonda, your statement requires some very important clarifications
1) your phrasing implies that there was a flaw in the methodology of the journal article rather than specifically noting that Theranos asserted there to be flawed methodology (A claim which other, independent, experts interviewed by the NYT did not agree with)
2) The blood clumping comment is, similarly, not an accurate representation of the article. The Dr. who noted the potential blood clustering issue was not noting it as a problem with the study methodology, he was noting it as a problem with Theranos' technology. This would contribute to error in Theranos' measurements, and the shift seen in the study. It would not contribute to error in the study itself. Theranos' assertion of error was about the vein blood draw causing error in the Theranos readings.
Further, the same Dr. whos words you are implying damages the credibility of the study is, instead, quite blunt about his opinion of Theranos
>“This represents just another effort for a failing company to cover up bad press for a technology that is not ready for prime time,” Dr. Frederick L. Kiechle, medical director for clinical pathology at Memorial Healthcare System in Hollywood, Fla., said about Theranos’s letter to the journal.
>Dr. Kiechle said it was known that cells in blood “tend to clump together and travel in groups,” so the tiny amount collected from a finger prick might not be representative.
EDIT: in the interest of transparency, I edited one sentence of this for clarity.
That's too reductive.
The WSJ cannot "forget to mention" a manuscript that wasn't published when their original articles came out.
The manuscript in question, an observational study, shows that Theranos has higher variation than standard labs for some tests, and that those tests are those that someone familiar with the field might suspect that a finger prick might have higher variation (e.g., lymphocytes).
The power of this manuscript is limited (in part because of Theranos not actively participating in peer-reviewed science like it's peers), but at a high level, it would hint that a physician sending a patient out for some particular labs would be wise to apply extra scrutiny to those lab values if the testing was by Theranos.
On one hand, it's possible that they're just too big to fail, considering the massive amount of capital they've raised and all of the vested interests put into the company. On the other hand, Enron comes to mind, which did end up failing and was fairly huge as well.
[1]: http://www.wsj.com/articles/theranos-has-struggled-with-bloo...
Chances of that are slim to none, they are damaged goods at this point. A number of existing customers has already cut ties to avoid further association and any future would-be investors would be very wary of putting more money in without iron-clad proof the technology is solid.
However a result that is wrong, but looks correct does not set off any alarm bells. You'd better hope that the physician requested a battery of tests and in correlating the results, sees the outlier. Otherwise you're potentially screwed.
In running tests on actual people, saving money comes far behind the overriding concerns around quality of results.
What prompted my comment was, "While most of the results were similar for the three labs, 12.2 percent of the measurements reported by Theranos were outside the expected normal range for healthy people, compared with 7.5 percent for Quest and 8.3 percent for LabCorp."
To me that sounds like at least some of the tests may be erring towards false positives. More research needed.
One classic example is a pregnancy test. You're going to find out eventually, and the impact of a false positive is huge, so the test errs toward false negatives instead of false positives.
This video does a good job explaining it (and is where I learned most of what I know): https://www.youtube.com/watch?v=UF1T7KzRnrs
Well yes, I wasn't suggesting jumping into treatment before verifying with the expensive, higher specificity test.
Even with pregnancy, the impact of a false positive isn't huge when the next step is just to take another test - the same test that would've been done anyway if the first one wasn't available.
Though the potential savings probably aren't great with pregnancy tests because they're already cheap, and I'd imagine the overall incidence for people taking the test is pretty high.
"There was as much variability between LabCorp and Quest as there was between Theranos and LabCorp or Theranos and Quest."(1)
Also a link to the actual paper in case anybody feels like reading it from the horse's mouth (2)
(1) http://www.techinsider.io/theranos-study-compares-blood-test...
(2) http://www.jci.org/articles/view/86318
Were personal computers replacing mainframes nuts?
> It's far more painful to take blood from a finger than from the MCV in your cubital fossa (arm).
Why didn't you just call it an arm?
> Then you have to go around touching things all day with a band-aid on your fingertips,
I've never had a band-aid for a finger-prick and do them constantly for checking blood sugar. Doctors never did it either.
Personal computers never replaced mainframes. Personal computers replaced minicomputers and workstations.
The difference is meaningful, even in this context: Minicomputers and workstations were high-end systems dedicated to things like relatively small-scale file storage, graphics processing, network tasks (servers, routers), and other workloads which required neither high throughput nor long up-times. They mainly required more RAM, CPU, and, sometimes, specialized hardware than it was feasible to put on a home system of the era.
Mainframes, on the other hand, had become specialized as high-throughput high-availability systems, running large databases and supporting dozens to hundreds of users at a time, for years on end. They'd grown entire specialized architectures dedicated to handling that kind of workload, and were only getting moreso as time went on.
My point is, if Theranos is the PC, it's only going to replace some aspects of the market it's moving into, and, from this article, it might not even do that. It's just too difficult to play catch-up with the extremely specialized realms, even if you have technology which is an 80% solution for 90% of the problems.
If you could really replace 10's of mls blood draws from the arm with a few drops (< 1 ml) drawn from the fingertip with no loss of clinically usable information, it would actually be a major breakthrough. There are distressingly large number of patients in hospitals requiring once a day (or even more frequent) blood draws to maintain correct treatment. The volume of blood and availability of veins and pain threshold can become actual, serious problems very quickly. This is doubly true in children.
If such tests were somehow found, they'll be noble-prize worthy scientific breakthroughs. Somehow Theranos is not giving off that vibe sadly.
Although I have my doubts Theranos blood tests are as acurate, I feel the study was pretty flawed.
Could you elaborate on why? My expertise is limited to an EMT certification that expired half a decade ago, but isn't obvious to me why this would be the case.
Blood is constantly circulating, and even a veinous blood drawn doesn't remove an appreciable amount of blood compared to the total flow.
When a you stick a needle in a persons arm you often trigger a flight-or-flight repsponse. It's actually fairly similar if you prick their finger. The problem with this study is that one was done after or before the other. It depends what you look for, but for example white blood count (which was tested) would/should change subtly after a blood draw.
The amount can vary (or not vary) depending on the person. For example, when I get my blood drawn my arm swells, it's not actually that I am allergic, but my body reacts in said way.
Regardless, my only comment was that the study seemed to be on somewhat shaky footing.
[1] http://www.frhg.org/documents/Lab_Manuals/Blood-Collection-A...
Interesting. What mechanism or phenomenon are you proposing would be happening? Why do you think sampling order has more influence than the sample method (venipuncture v. finger prick)?
> Further, when the baseline (i.e. other labs) also have varying results, its fair to call into question the whole study.
Why? That's an expected outcome when dealing with multiple testing labs.
Furthermore, it's hard to imagine how results could be dramatically altered. How would having a previous finger prick blood test for say glucose level, cholesterol, triglycerides, blood count (CBC), calcium levels, blood urea levels, or the presence of antibodies possibly change the results of a subsequent test?
If true, this raises two questions in my mind:
1. Were the non-Theranos machines approved for testing diluted blood samples? The technology may be approved only for blood samples with normal concentration.
2. Were the non-Theranos machines qualified to test blood samples collected by any method? Some researchers think that capillary blood collected with a fingerstick may be too contaminated to produce accurate results.
In other words, was Theranos negligent with respect to federal regulations for use of these machines? Someone with clinical lab experience may want to weigh in.
http://www.scribd.com/doc/306187782/Theranos-Letter-to-JCI
So on that first paragraph, are they implying that the journal should have provided Theranos with a copy of the manuscript for review and comment? Maybe I'm not reading that charitably, but that's not how the system works, and I don't think scolding the journal (page 3) over manuscript decisions is an appropriate response.
The second paragraph is strikes me as a bit rich considering the reputation Theranos has for secrecy. As best I can tell, they still haven't published the more detailed information on their technology that they promised when the WSJ first broke the story?
Were I the editor, I think my response might be along the lines of "you raise some excellent points, and so we invite you to submit a research manuscript for accelerated review".
My opinion is that Theranos should still be a small biotech company operating in R&D mode. They had no business going to market with a methodology and a product that were unproven and entirely hidden from scientific peer review. After the dust settles and they reorganize, that’s probably what will happen. Theranos should also allow their investors to pull out without any consequences.
I'm amazed that they (or the people who contracted them) are not getting sued. If they mess up a blood test, someone could get mistreated and die.
By calling out the lack of peer review, I'm referring to the science behind the use of fingerstick sampling. When you extract blood from a vein with a sterile needle, the blood is uncontaminated. When you stab someone’s finger with a blade or sharp pin, presumably you have lacerated hundreds or thousands of capillaries. The blood that emerges is contaminated by tissues inside the finger and by oils and bacteria on the surface of the finger.
It’s possible to do simple tests like iron level with this blood and get accurate results. More complicated tests are another matter, and require scientific investigation.
http://techcrunch.com/2016/03/31/government-report-details-t...
Is this so? I don't see how one could affect the other.
I suppose they are popular due to some combination of schadenfreude and the morbid fascination that comes from watching a slow motion train wreck. But I find these articles empty of anything remotely interesting let alone any edifying content. They are just a monthly sign post for the accumulation of disparaging comments about Theranos.