Theranos got a law changed in Arizona so that patients could order their own blood tests. Where does the liability fall if patients order their own blood test but they get the test from a really inaccurate blood testing company?
Yes another eerie similarity to Smile Direct. They had their hand in redefining some laws tipped in their favor in New Mexico recently.
I wanted to scream at that scene where she grifted her way into the AZ legislature and was testifying and the rep was falling all over himself to praise her. WTF, dude.
I totally missed that scene! I read it in an article but I definitely need to rewatch this. We were watching after midnight and DS kept waking up.
I wanted to scream at that scene where she grifted her way into the AZ legislature and was testifying and the rep was falling all over himself to praise her. WTF, dude.
I remember thinking "So, really, all you have to be is blond and relatively cute and men will literally fall all over themselves to help you??".
I think humans are much more "base" creatures than we all want to believe sometimes.
I just watched this last night. I think blonde and good-looking certainly helped, but what I took away from the documentary was just how much growing up privileged and connected sealed the deal for her. She was friends with Tim Draper’s daughter and her dad was friends with Victor Palmieri — basically rich white dudes whose involvement as early investors then brought in other rich white dudes.
I don’t think many pretty young women could pull this off without those ties. This is basically like Trump appointing his son-in-law to make peace in the Middle East — lies built on nepotism. And it’s the way our world works far too often.
Her fake voice was cringeworthy. At least make it good. The amount of delusion on everyone’s part, is staggering.
i want to know if she just did it on her own or is there a voice coach out there who helped her learn to talk with a deeper voice.
I think it was on her own. She wanted to be Jobs in such a creepy manner.
and I was bothered that she played on people's emotions that this could buy you more time, "one more day" with a loved one who might have cancer or some other illness. THis was not about someone truly wanting to help people, but wanting to be a billionaire.
I just watched this last night. I think blonde and good-looking certainly helped, but what I took away from the documentary was just how much growing up privileged and connected sealed the deal for her. She was friends with Tim Draper’s daughter and her dad was friends with Victor Palmieri — basically rich white dudes whose involvement as early investors then brought in other rich white dudes.
I don’t think many pretty young women could pull this off without those ties. This is basically like Trump appointing his son-in-law to make peace in the Middle East — lies built on nepotism. And it’s the way our world works far too often.
This was my take away as well. I wanted more background on her family, because it seems like they were loaded and she had access to connections that could throw away millions on a really interesting idea and not worry about it. The folks investing in her were investing in TONS of early stage companies. They likely only need a few to hit for things like Theranos not to matter one bit. It isn't like these folks were going bankrupt and not being able to feed and clothe their kids just because she was a liar.
I just watched this last night. I think blonde and good-looking certainly helped, but what I took away from the documentary was just how much growing up privileged and connected sealed the deal for her. She was friends with Tim Draper’s daughter and her dad was friends with Victor Palmieri — basically rich white dudes whose involvement as early investors then brought in other rich white dudes.
I don’t think many pretty young women could pull this off without those ties. This is basically like Trump appointing his son-in-law to make peace in the Middle East — lies built on nepotism. And it’s the way our world works far too often.
This was my take away as well. I wanted more background on her family, because it seems like they were loaded and she had access to connections that could throw away millions on a really interesting idea and not worry about it. The folks investing in her were investing in TONS of early stage companies. They likely only need a few to hit for things like Theranos not to matter one bit. It isn't like these folks were going bankrupt and not being able to feed and clothe their kids just because she was a liar.
YES! Even before they mentioned all her connections, I kept thinking, there’s no way this woman didn’t grow up rich. And sure enough — rich with political ties.
Also, someone mentioned upthread how weird it was the one investor was like, well, her grandfather and uncle had these skills so she must have them too. But that’s exactly how nepotism works. Well, I knew her grandfather/uncle, he did alright, the kid’s probably going to do alright too; I’ll throw some money her way ...
Does anyone have any thoughts on the Theranos concept? I hate to say if I had any money I might have thrown it her way. We have been testing glucose levels in blood in a handheld device for like 40-50 years. We now have capabilities to test other things in our blood with a finger prick and a handheld device. Cholesterol and ketones come to mind. It doesn’t seem super far fetched what she was proposing, but what do I know.
Anyway, thoughts on the concept and it’s feasability, not the manner in which she lied, deceived, etc. Just curious.
Does anyone have any thoughts on the Theranos concept? I hate to say if I had any money I might have thrown it her way. We have been testing glucose levels in blood in a handheld device for like 40-50 years. We now have capabilities to test other things in our blood with a finger prick and a handheld device. Cholesterol and ketones come to mind. It doesn’t seem super far fetched what she was proposing, but what do I know.
Anyway, thoughts on the concept and it’s feasability, not the manner in which she lied, deceived, etc. Just curious.
Cholesterol is available with a finger stick and you use a urine dipstick for ketones. There are several others (INR, troponin, ABG, etc).
Does anyone have any thoughts on the Theranos concept? I hate to say if I had any money I might have thrown it her way. We have been testing glucose levels in blood in a handheld device for like 40-50 years. We now have capabilities to test other things in our blood with a finger prick and a handheld device. Cholesterol and ketones come to mind. It doesn’t seem super far fetched what she was proposing, but what do I know.
Anyway, thoughts on the concept and it’s feasability, not the manner in which she lied, deceived, etc. Just curious.
The main issue is that not all analytes are tested the same way. It would be very very difficult to fit all the necessary equipment and reagents for all the tests she wanted to do in a small box and with such a small amount of blood. Theres a reason why they had no chief medical officer and didnt get any investments from any VCs that normally would invest in these types of things.*
*Ive read the book and listened to the podcast but havent seen the hbo special yet. I work in drug regulatory affairs and used to work as an analytical chemist (environmental, not medical) so most of this story is beyond shocking to me for so many reasons). And i only know like the smallest bit about device regulations, let alone CMS and diagnostics. It's just not how any of this works.
Does anyone have any thoughts on the Theranos concept? I hate to say if I had any money I might have thrown it her way. We have been testing glucose levels in blood in a handheld device for like 40-50 years. We now have capabilities to test other things in our blood with a finger prick and a handheld device. Cholesterol and ketones come to mind. It doesn’t seem super far fetched what she was proposing, but what do I know.
Anyway, thoughts on the concept and it’s feasability, not the manner in which she lied, deceived, etc. Just curious.
I been going down this rabbit hole for the last week and someone on Reddit linked a long thread from a forum of pathologists who were saying back in 2014 that it was impossible. Some of their points were that it’s already possible to get test results turned around really quick and have the results online in many markets. That milking the finger to get blood can take more time and be more painful than venipuncture because the finger is not a good site to get blood in general (I have to agree based on my gestational diabetes experience). Pricing the tests way below even Medicare rates should have been a clue something was up because Medicare rates are what every insurance follows and are already among the lowest rates. I can find and link their discussion later tonight.
And she had the female professor tell her that her idea was impossible and her response was basically shrug.
Does anyone have any thoughts on the Theranos concept? I hate to say if I had any money I might have thrown it her way. We have been testing glucose levels in blood in a handheld device for like 40-50 years. We now have capabilities to test other things in our blood with a finger prick and a handheld device. Cholesterol and ketones come to mind. It doesn’t seem super far fetched what she was proposing, but what do I know.
Anyway, thoughts on the concept and it’s feasability, not the manner in which she lied, deceived, etc. Just curious.
The main issue is that not all analytes are tested the same way. It would be very very difficult to fit all the necessary equipment and reagents for all the tests she wanted to do in a small box and with such a small amount of blood. Theres a reason why they had no chief medical officer and didnt get any investments from any VCs that normally would invest in these types of things.*
*Ive read the book and listened to the podcast but havent seen the hbo special yet. I work in drug regulatory affairs and used to work as an analytical chemist (environmental, not medical) so most of this story is beyond shocking to me for so many reasons). And i only know like the smallest bit about device regulations, let alone CMS and diagnostics. It's just not how any of this works.
So basically anyone with the slightest knowledge in this area would have been able to say ‘there’s no way this can ever work’? This whole debacle just keeps getting more and more fascinating to me.
Does anyone have any thoughts on the Theranos concept? I hate to say if I had any money I might have thrown it her way. We have been testing glucose levels in blood in a handheld device for like 40-50 years. We now have capabilities to test other things in our blood with a finger prick and a handheld device. Cholesterol and ketones come to mind. It doesn’t seem super far fetched what she was proposing, but what do I know.
Anyway, thoughts on the concept and it’s feasability, not the manner in which she lied, deceived, etc. Just curious.
Cholesterol is available with a finger stick and you use a urine dipstick for ketones. There are several others (INR, troponin, ABG, etc).
m
Ketones can be via finger stick as well, not just urine. Not sure but this may actually be there preferred way to test for diabetics.
The main issue is that not all analytes are tested the same way. It would be very very difficult to fit all the necessary equipment and reagents for all the tests she wanted to do in a small box and with such a small amount of blood. Theres a reason why they had no chief medical officer and didnt get any investments from any VCs that normally would invest in these types of things.*
*Ive read the book and listened to the podcast but havent seen the hbo special yet. I work in drug regulatory affairs and used to work as an analytical chemist (environmental, not medical) so most of this story is beyond shocking to me for so many reasons). And i only know like the smallest bit about device regulations, let alone CMS and diagnostics. It's just not how any of this works.
So basically anyone with the slightest knowledge in this area would have been able to say ‘there’s no way this can ever work’? This whole debacle just keeps getting more and more fascinating to me.
Pretty much. There was that professor at stamford (who i think is in the movie) who told her her first idea was impossible - the patch that would both diagnose and treat disease. This is a little less crazy, but still, pretty out there and nearly impossible. The idea would have totally revolutionize medicine, so i think people were just incredibly hopeful. I mean, if you dont know anything about this stuff, it doesnt sound too far-fetched, but it is.
I also have so many issues with how they totally went around fda and were using these on real patients. There was no mention of an IRB (which decides if clinical studies are ethically ok among other things), but im guessing there wouldve had to be since pfizer used the machines, supposedly. I know all the clinical studies (which have all been later stage) ive been involved in dont use ANY experimental methods (eta: unless its to test/validate a method, not a drug). Everything is validated. Everything is published in peer-reviewed journals. Clinical studies are so expensive and take so long that you dont want to mess it because an analysis or a device isnt working. It's all mind-boggling to me. But ive only worked at big, established definitely not start up companies, that are much more on the conservative side.
So basically anyone with the slightest knowledge in this area would have been able to say ‘there’s no way this can ever work’? This whole debacle just keeps getting more and more fascinating to me.
Pretty much. There was that professor at stamford (who i think is in the movie) who told her her first idea was impossible - the patch that would both diagnose and treat disease. This is a little less crazy, but still, pretty out there and nearly impossible. The idea would have totally revolutionize medicine, so i think people were just incredibly hopeful. I mean, if you dont know anything about this stuff, it doesnt sound too far-fetched, but it is.
I also have so many issues with how they totally went around fda and were using these on real patients. There was no mention of an IRB (which decides if clinical studies are ethically ok among other things), but im guessing there wouldve had to be since pfizer used the machines, supposedly. I know all the clinical studies (which have all been later stage) ive been involved in dont use ANY experimental methods. Everything is validated. Everything is published in peer-reviewed journals. Clinical studies are so expensive and take so long that you dont want to mess it because an analysis or a device isnt working. It's all mind-boggling to me. But ive only worked at big, established definitely not start up companies, that are much more on the conservative side.
Agree that using it on real patients was maddening.
Pretty much. There was that professor at stamford (who i think is in the movie) who told her her first idea was impossible - the patch that would both diagnose and treat disease. This is a little less crazy, but still, pretty out there and nearly impossible. The idea would have totally revolutionize medicine, so i think people were just incredibly hopeful. I mean, if you dont know anything about this stuff, it doesnt sound too far-fetched, but it is.
I also have so many issues with how they totally went around fda and were using these on real patients. There was no mention of an IRB (which decides if clinical studies are ethically ok among other things), but im guessing there wouldve had to be since pfizer used the machines, supposedly. I know all the clinical studies (which have all been later stage) ive been involved in dont use ANY experimental methods. Everything is validated. Everything is published in peer-reviewed journals. Clinical studies are so expensive and take so long that you dont want to mess it because an analysis or a device isnt working. It's all mind-boggling to me. But ive only worked at big, established definitely not start up companies, that are much more on the conservative side.
Agree that using it on real patients was maddening.
Thanks for sharing your personal insights.
Sure! My book club is reading it this month, and im pretty sure they picked it because its partly me, a doctor, and someone who works in a biotech lab (and 3 people who do NOTHING related) so itll be interesting to hear everyones POV.
This story is maddening for so many reasons. Beyond the issues i have with it professionally, my personal feeling is that she wanted to be steve jobs so badly, but he failed, a lot, for a long time, and she seemed to have zero tolerance for failure. She was clearly intelligent, and had really big ideas, but she didnt have the experience or maturity to actually contribute to society in some meaningful way. It's another case of big ego getting in the way.
So basically anyone with the slightest knowledge in this area would have been able to say ‘there’s no way this can ever work’? This whole debacle just keeps getting more and more fascinating to me.
Pretty much. There was that professor at stamford (who i think is in the movie) who told her her first idea was impossible - the patch that would both diagnose and treat disease. This is a little less crazy, but still, pretty out there and nearly impossible. The idea would have totally revolutionize medicine, so i think people were just incredibly hopeful. I mean, if you dont know anything about this stuff, it doesnt sound too far-fetched, but it is.
I also have so many issues with how they totally went around fda and were using these on real patients. There was no mention of an IRB (which decides if clinical studies are ethically ok among other things), but im guessing there wouldve had to be since pfizer used the machines, supposedly. I know all the clinical studies (which have all been later stage) ive been involved in dont use ANY experimental methods (eta: unless its to test/validate a method, not a drug). Everything is validated. Everything is published in peer-reviewed journals. Clinical studies are so expensive and take so long that you dont want to mess it because an analysis or a device isnt working. It's all mind-boggling to me. But ive only worked at big, established definitely not start up companies, that are much more on the conservative side.
It seems like they exploited loopholes in CLIA that allowed them to use the tests in their own labs without getting regulatory clearance. This has been a known issue for a LONG time, and they’re far from the only company using these so-called “laboratory-developed tests” as a workaround to avoid sharing the details of what they’re doing.
CLIA was never intended to be for mass-market diagnostics — it was a shortcut, of sorts, so academics at research universities could run their own assays without having to get FDA clearance for a “medical device.”
But most people don’t know that many companies like Myriad Genetics (which makes the breast cancer gene-screening test) and 23andMe are all examples of companies that jumped into the market with only CLIA certification (though, like Myriad, they may have gotten FDA approval later on.)
Pretty much. There was that professor at stamford (who i think is in the movie) who told her her first idea was impossible - the patch that would both diagnose and treat disease. This is a little less crazy, but still, pretty out there and nearly impossible. The idea would have totally revolutionize medicine, so i think people were just incredibly hopeful. I mean, if you dont know anything about this stuff, it doesnt sound too far-fetched, but it is.
I also have so many issues with how they totally went around fda and were using these on real patients. There was no mention of an IRB (which decides if clinical studies are ethically ok among other things), but im guessing there wouldve had to be since pfizer used the machines, supposedly. I know all the clinical studies (which have all been later stage) ive been involved in dont use ANY experimental methods (eta: unless its to test/validate a method, not a drug). Everything is validated. Everything is published in peer-reviewed journals. Clinical studies are so expensive and take so long that you dont want to mess it because an analysis or a device isnt working. It's all mind-boggling to me. But ive only worked at big, established definitely not start up companies, that are much more on the conservative side.
It seems like they exploited loopholes in CLIA that allowed them to use the tests in their own labs without getting regulatory clearance. This has been a known issue for a LONG time, and they’re far from the only company using these so-called “laboratory-developed tests” as a workaround to avoid sharing that they’re doing.
CLIA was never intended to be for mass-market tests — it was developed so academics at research universities could run their own assays without having to get FDA clearance as a “medical device.”
But most people don’t know that many companies like Myriad Genetics (which makes the breast cancer gene-screening test) and 23andMe are all examples of companies that jumped into the market with only CLIA certification (though, like Myriad, they may have gotten FDA approval later on.)
Oh they definitely did, but the blood collection devices and finger prick things are definitely medical devices. Anything that would be used at a walgreens to collect blood would still be covered by FDA. Im sure (i assume?) that what 23andme, for example, uses to collect samples are probably previously existed, compliant devices.
Eta FDA did eventually bust them on that, but its amazing to me that they didnt even consider they had to go through fda.
I think the concept is very appealing (if impossible). I did keep wondering, even if they could run the tests, how would they sterilize the box between uses?
The main issue is that not all analytes are tested the same way. It would be very very difficult to fit all the necessary equipment and reagents for all the tests she wanted to do in a small box and with such a small amount of blood. Theres a reason why they had no chief medical officer and didnt get any investments from any VCs that normally would invest in these types of things.*
*Ive read the book and listened to the podcast but havent seen the hbo special yet. I work in drug regulatory affairs and used to work as an analytical chemist (environmental, not medical) so most of this story is beyond shocking to me for so many reasons). And i only know like the smallest bit about device regulations, let alone CMS and diagnostics. It's just not how any of this works.
So basically anyone with the slightest knowledge in this area would have been able to say ‘there’s no way this can ever work’? This whole debacle just keeps getting more and more fascinating to me.
I mean maybe it could work at some point but the pathologists shook their head at their organization not being able to come out and say "THIS IS NOT HOW BLOOD WORKS." I know in my field there is a lot of frustration that our organizations are scared to say anything really strong speaking out against some of the borderline harmful things out there because these big companies with deep pockets go after the organization for restricting trade. So instead you get this wordy "official statement" they release that the public never really sees as they order their smile aligners or buy charcoal toothpaste. And they were also glad that the WSJ brought the whole thing down because even with the patients in Arizona getting poor results, no one was stopping this company because what power does an individual patient have? So you got a bad result and suffered a bit or even a lot. Does anyone care? Not Theranos, not Walgreens. How do you (the average public) even go about complaining when you've been served bad medicine? Especially when the people who brought you the bad medicine got there because of loop holes at the FDA and the government passing special laws for them because "disruption."
So basically anyone with the slightest knowledge in this area would have been able to say ‘there’s no way this can ever work’? This whole debacle just keeps getting more and more fascinating to me.
I mean maybe it could work at some point but the pathologists shook their head at their organization not being able to come out and say "THIS IS NOT HOW BLOOD WORKS." I know in my field there is a lot of frustration that our organizations are scared to say anything really strong speaking out against some of the borderline harmful things out there because these big companies with deep pockets go after the organization for restricting trade. So instead you get this wordy "official statement" they release that the public never really sees as they order their smile aligners or buy charcoal toothpaste. And they were also glad that the WSJ brought the whole thing down because even with the patients in Arizona getting poor results, no one was stopping this company because what power does an individual patient have? So you got a bad result and suffered a bit or even a lot. Does anyone care? Not Theranos, not Walgreens. How do you (the average public) even go about complaining when you've been served bad medicine? Especially when the people who brought you the bad medicine got there because of loop holes at the FDA and the government passing special laws for them because "disruption."
Thanks for sharing that thread. I got about 20 posts in (plan to read it all later) and yeah, they seem to see right through all of it.
They mention later on that it was a pathologist who helped bring the issue to the WSJ in the first place. Kudos to WSJ for paying attention. But before that, whose opinion would sell more magazines that helped grow this monster? Some random pathologist or Henry Kissinger?
I only watched 20/20 and have podcast and hbo to go. Like others, I’m just fascinated by this. I really don’t get how Walgreens fell for this. Are there no regulations or just how did they just sign on for this? I didn’t see that explained on 20/20. A well known pharmacy running fake blood tests should be just as big of a story in my opinion.
I only watched 20/20 and have podcast and hbo to go. Like others, I’m just fascinated by this. I really don’t get how Walgreens fell for this. Are there no regulations or just how did they just sign on for this? I didn’t see that explained on 20/20. A well known pharmacy running fake blood tests should be just as big of a story in my opinion.
Agree. Especially considering that were doing veinous blood draws and shipping the samples. That is not at all what Theranos advertised!!
I only watched 20/20 and have podcast and hbo to go. Like others, I’m just fascinated by this. I really don’t get how Walgreens fell for this. Are there no regulations or just how did they just sign on for this? I didn’t see that explained on 20/20. A well known pharmacy running fake blood tests should be just as big of a story in my opinion.
I'm not a lawyer so I don't understand a lot of this, but there is this (court?) document that outlines how Walgreen ignored their own research and went ahead with this. Go to page 13, "Walgreens blindly jumps." Does anyone know if this class action lawsuit is still a thing or was it resolved?
Post by maudefindlay on Nov 18, 2022 12:06:01 GMT -5
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Elizabeth Holmes is being sentenced today. She has a toddler now and is pregnant. Defense wants 18 months and served at home. Get put of here with that! I feel compassion for the kids, but she duped so many and put lives at risk.
Elizabeth Holmes is being sentenced today. She has a toddler now and is pregnant. Defense wants 18 months and served at home. Get put of here with that! I feel compassion for the kids, but she duped so many and put lives at risk.
There are so many parents in prison. She deserves no special treatment.
I only watched 20/20 and have podcast and hbo to go. Like others, I’m just fascinated by this. I really don’t get how Walgreens fell for this. Are there no regulations or just how did they just sign on for this? I didn’t see that explained on 20/20. A well known pharmacy running fake blood tests should be just as big of a story in my opinion.
A couple years ago I saw a panel with Tyler Schultz, one of the main whistleblowers, and an exec from Walgreens. One thing she said was that when they originally agreed to the pilot, it was for a small number of stores and generally a tiny project in the scheme of things for a company their size. Then management got caught up with the huge Boots merger/acquisition, and meanwhile Theranos was becoming a tech wonder story with Holmes on the covers of magazines and headlining conferences etc. Nobody went back and re-assessed the risk or dialed up the due diligence in accordance with how things evolved.
Elizabeth Holmes is being sentenced today. She has a toddler now and is pregnant. Defense wants 18 months and served at home. Get put of here with that! I feel compassion for the kids, but she duped so many and put lives at risk.
When was she convicted?
I may be an asshole (probably) but maybe you shouldn’t have kids when you’re probably going to jail. I realize not everyone has the education, means and privilege to plan like that, but she doesn’t fall into that category.
And my second asshole comment of the thread: I wonder if she DID plan on having children in order to try to get out of serving her time in prison.
Elizabeth Holmes is being sentenced today. She has a toddler now and is pregnant. Defense wants 18 months and served at home. Get put of here with that! I feel compassion for the kids, but she duped so many and put lives at risk.
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When was she convicted?
I may be an asshole (probably) but maybe you shouldn’t have kids when you’re probably going to jail. I realize not everyone has the education, means and privilege to plan like that, but she doesn’t fall into that category.
And my second asshole comment of the thread: I wonder if she DID plan on having children in order to try to get out of serving her time in prison.
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Well, she's almost 40. Assuming that she gets 15 or 20 years in prison, her childbearing years will be over after she gets out of prison. So, this was her last chance to have children.