16 ms·

FDA warning brings young-blood transfusion company to a halt

120 points by mips_avatar 8y ago

dswalter 8y ago
In the wake of the Theranos debacle, I would expect to see the FDA take a stronger stance against medical startups that are taking actions that have real potential impact without evident clinical support.
- mc32 8y ago
  At least theranos had real, good scientists doing real research work. Of course we know management went awry [failing to admit defeat and pushing on despite the problems] and threw everyone under the bus, but they had real researchers. This company here from the outside looks closer to quackery. [and can't imagine them having a good team of scientists behind it].
  - theli0nheart 8y ago
    Management never "went" awry. The whole thing was a fraud from day one. And hiring "real researchers" to front your fraudulent operation as a way to hide what's going on behind the scenes shouldn't be reason to look the other way. In some ways it's worse than the alternative, since there's not just fraud, but activity intended to take attention away from it.
    - Fricken 8y ago
      It wasn't a fraud from day one, Elizabeth Holmes was a teenager when she got started on Theranos, she had no idea at that time that it had no chance of working. Uncle Tim gave her $200k in seed funding and she ran with it. Shit got progressively more fucked up along the way.
      - SilasX 8y ago
        Yes, and she bought into the “fake it till you make it”, “no one knows what they’re doing”, “all self doubt is impostor syndrome” mentality that’s so popular on this site and which inevitably leads to idealistic people doubling down on fundamentally confused ventures where they should have realized they’re out of their depth.
        Fricken 8y ago
        Are those attitudes really that popular on HN? Most of the comments I see are pretty cycnical about emerging technologies and longshot bets. The thing is, after she got that $200k in branded VC capital from family friend Tim Draper, Holmes went knocking on the doors of all the big silicon valley VC firms and all the big bio-sciences VC firms. They consulted with blood scientist type people who informed them device had zero chance of living up to it's promise. All of them said "Sorry Elizabeth, we must politely decline your invitation to flush our money down the toilet." The money she did get after that seed funding was from fly-by night wannabe VCs, and the bandwagon effect took off from there. Who did their due diligence? Nobody. I'm not shedding any tears for Rupert Murdoch, but there were hedge fund managers in charge of people's pensions who gave Theranos 100s of millions of dollars without looking into what it was they were spending other people's money on. It baffles me that anyone that stupid can get to be in charge of that much money in the first place.
        asveikau 8y ago
        I think what the parent means is that it is indeed very popular on many tech sites where career discussion occurs to overstate imposter syndrome and imply that solid competence without imposter syndrome does not exist, everyone is just faking it. Imposter syndrome is a real phenomenon and successful people are mere mortals who should not be put on pedestals. But it's possible to attribute too much to these factors. And dishonesty (faking it) should not be where you turn.
        dmix 8y ago
        I’ve been on this site forever and I remember the early Theranos articles were highly skeptical or had as little information about what they were actually doing as this site has primarily programmers and software people, not as much people in bio. Regardless faking state-funded health experiments in a heavily regulated industry has nothing to do with fail fast mentality of the software world either (just like how everyone here criticized that personal banking startup who tried that in the heavily regulated finance industry). We have nothing to defend here.
  - twtw 8y ago
    Did theranos have anyone doing real research work? My understanding was that theranos had real, good scientists who were continuously pressured to fabricate results and do quick hacks to keep up appearances. What real research work could anyone have been doing if everyone there was ignoring the fact that their procedures and equipment did not product accurate results?
    - mc32 8y ago
      Good question, I don't know. It's possible they were sent on wild goose chases knowing they were in vain and just a front. I have no idea, but I know they had good scientists in their employ. In any event, research labs have many lines of inquiry and separate teams working on their specialty. I don't know if they produced good IP, just that they had good scientists working for them, and have moved on to other reputable companies since. This outfit singled out by the FDA though, it looks like complete fraud.
      - nradov 8y ago
        Any scientist who compromised his or her ethics by continuing to work for Theranos after seeing how they operated from the inside was not "good", by definition. Their reputations will be stained forever.
        mc32 8y ago
        Not necessarily. Teams aren’t privy to everything in other teams. It's possible their reps be stained forever, but it's not all deserved. Mgmt can be deceptive. Just because you're an expert in one line of inquiry does not mean you're an expert in another (and can call out fakery, esp if it's kept from them).
        asveikau 8y ago
        Unethical people can hide it well. They probably also had people at all stages of their careers, eg. imagine a very junior person being impressed with the position, with very little work experience to be able to see through office sociopathy. I am sorry for anyone who now has such a stain on their record after being exploited like that.
  - deleted 8y ago
    [deleted]
  - newnewpdro 8y ago
    Any scientist/researcher with Theranos on their CV should be viewed as complicit in the fraud, not exempted from it.
transfire 8y ago
I'd rather hear from the people brave enough to have tried this to gain their perspective.
- hannasanarion 8y ago
  Why do you think that someone who would literally suck your blood out of your veins so that they can live forever would bother to tell you what it feels like? Why are we pretending this is anything but horrifying? We have multiple works of dystopia and horror fiction about this very premise: The Golden Compass, The Waterworks, Get Out, The Supernaturalist, Unwind...
  - sanxiyn 8y ago
    > someone who would literally suck your blood out of your veins Blood is renewable. You aren't losing blood you donate (or sell).
  - gavrif 8y ago
    https://www.lesswrong.com/posts/rHBdcHGLJ7KvLJQPk/the-logical-fallacy-of-generalization-from-fictional https://www.lesswrong.com/posts/rHBdcHGLJ7KvLJQPk/the-logica...
- ggm 8y ago
  I don't quite get the intent behind rather here. I too would like to hear from people who tried this, but its not a preference to being told the FDA is clamping down, its just another perspective. Nicotine addicts like taking nicotine irrespective of the 101 toxic chemicals in smoke they get along side it. I'd rather the Surgeon General didn't say "oh well, let them do what they want" I also have views around paid blood and organ donation in general. I think its a bad idea.
succubis 8y ago
Before we start sucking the blood out of the veins of young people, let’s make sure we have all our other compulsory economic transactions eliminated. All the essentials like: - showing up to work - putting clothes on your back - putting food in your belly - putting a roof over your head - having an actual family ...of some kind, not just loose-knit acquaintances that you watch movies, TV and play video games with, not internet friends. People who would do more than share a room with you for the purpose of polite conversation. Then, we can talk about how and why people might open up the faucet, and let strangers tap their veins, when they’re barely old enough to make choices like drink, fuck and smoke cigarettes. We do expect this to be a choice, right? This brokering of blood? Not an option to confront out of financial desperation? Really, though, I’d rather see people grow their own genetically cloned vats of blood, than accept externally sourced transfusions at all. The young blood that enters your veins should be sourced from in vitro repositories, not pulled from people that match your type, but are otherwise genetically distinct. It shouldn’t even come from anliving twin. It should be cloned from your own body.
BurningFrog 8y ago
How can plasma transfusions not have gone though rigorous testing? Has it not been done routinely millions of times for decades? I understand it's not been proven to have any health benefit. But the safety of the procedure must be extremely well known.
- ianhowson 8y ago
  For a treatment to be granted 'FDA approval', the FDA needs to see evidence of two things: safety and efficacy. Even if a treatment is demonstrated to be safe, if there's no evidence of therapeutic benefit, they won't approve it.
  - deleted 8y ago
    [deleted]
  - BurningFrog 8y ago
    Yeah, if you parse out the words, that is all they're actually saying. "There is no proven clinical benefit" and "there are risks associated with the use of any [...] product".
    - ianhowson 8y ago
      They're also not saying "Ambrosia Medical must stop administering this treatment". They're just saying "we don't approve". So this thing on the Ambrosia website: > In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments. doesn't quite make sense, because the FDA hasn't publicly asked Ambrosia to stop, and the FDA never did approve transfusions for the purpose of life extension or anti-aging. They're not complying with anything, because that announcement wasn't a 'cease treatments' notice. So we don't really know why Ambrosia has chosen to stop.
  - magduf 8y ago
    So why is chiropractic and homeopathy allowed?
DKnoll 8y ago
I think a good enough reason to forbid it would be to prevent companies from paying donors more (or at all) and diverting blood that could be used for necessary medical treatments.
- mips_avatar 8y ago
  I don’t think this should be allowed as a treatment, if it’s efficacy hasn’t been established. But I wish there were a trial. I want to be able to live healthily to 100.
  - rscho 8y ago
    ...by feeding upon material which is already limited in availability for providing treatment to people younger than you are.
  - nradov 8y ago
    There is zero scientific basis to expect that this would allow people to live healthily to 100. We have limited resources for clinical trials and those resources should be focused on areas more likely to produce useful results.
    - mips_avatar 8y ago
      I haven’t seen any evidence for it either. But I’d like to see the FDA support aging treatments more. The affect of an extra 10 years of healthy life would be huge.
    - ibeckermayer 8y ago
      And what precisely gives you (or the bureaucrats running the FDA) the authority to decide for everybody in America what is the best use of our blood? I should be free to decide for myself what to do with my own body, and which authorities to trust on matters beyond my domain of expertise. If you have a good argument for why this is a waste of resources then make the argument, don’t legistlatively prohibit me from thinking for myself.
dmourati 8y ago
I'm reminded of the title of a distributed systems post the original appears to be no longer working but here's a HN link: https://news.ycombinator.com/item?id=12245909 https://news.ycombinator.com/item?id=12245909
CaliforniaKarl 8y ago
The company mentioned, Ambrosia Medical, has been on HN before. https://news.ycombinator.com/item?id=14470314 https://news.ycombinator.com/item?id=14470314 From the Vanity Fair article that the above linked to, it seemed it was run by Jesse Karmazin, with Peter Thiel either as a booster, or maybe providing funding? The article isn't clear on that, although he's mentioned (and quoted) multiple times.
rscho 8y ago
For some reason, the only appropriate name that comes to my mind for such companies is "Bathory".
- porphyrogene 8y ago
  Dr. Acula would like a word with you.
ErikAugust 8y ago
No JavaScript, etc: https://beta.trimread.com/articles/92 https://beta.trimread.com/articles/92
duchenne 8y ago
I am now reading "Red Star" a 1908 utopian novel by Alexander Bogdanov, where another advanced Humanity is living on Mars. In this Utopia, people frequently transfer blood one from another. The author presents blood donation as one of the greatest form of Fraternity. Interestingly, Bogdanov founded one of the first blood transfer institute with only volunteering donors. At that time, most blood donations were paid. Later on, thanks to better conservation techniques, less blood was needed, and volunteering became generalized world-wide. Bogdanov also believed that blood donation could rejuvenate people. His wife said that he looked 7-10 years younger after his experiments. But, in the end, he died, because he received malaria-infected blood. That is interesting to know that some 2019 issues already existed more than a century ago: blood transfer, paying for blood, rejuvenation, etc..
- Pristina 8y ago
  they are actual non-problems. If you own your body, you own your blood. You should be able to sell or do whatever you please with it. If some people think they can become younger by bathing in young blood, let them. It's their money and time, and blood too, as long as they buy the blood legitimately.
  - zimablue 8y ago
    >If you own your body => you own your blood => you can do whatever the hell you want with it > If you own your body you own your hands => you can do whatever you want (murder) with them > That argument doesn't stand, I'm saying you can do anything you want with them that doesn't harm anyone else > Interesting, what's your definition of harming someone? If I control all the mechanisms of law and create a situation where every other person is effectively my slave (eg. I own all the land), then where in your libertarian philosophy do we fight that? Or do we just accept it? I'm telling you with love in my heart, that taking a simplified libertarian view of everything is an intellectual trap and the world is way, way more complicated economically and philosophically than can be managed through libertarianism. In the same way that gender politics gets disproportionate airtime because 1. it's very feel-good for groups of girls to feel united over and get a thrill of moral superiority from, it works socially 2. it's something for the elites/rich people to focus on that isn't redistribution or reform Libertarianism gets press because: 1. People love having a single rule for things, because it makes them feel clever and right often without having to do any actual thinking. And it's clever on light inspection and dumb on deeper thinking 2. see gender politics 2.
jfultz 8y ago
It's like the company used Normal Spinrad's "Bug Jack Barron" and the goofy sci-fi premise invented by its mustache-twirling villain as an operating manual.
kkarakk 8y ago
Has there been any research on what happens when you pump "old-blood" into young people? any gains in wisdom/maturity/dementia?
- jokowueu 8y ago
  On mice only
kfwhp 8y ago
Are there any actual, proven benefits to these blood transfusions, or are they just something rich people like to do for the sake of it?

120 points by mips_avatar 8y ago

In the wake of the Theranos debacle, I would expect to see the FDA take a stronger stance against medical startups that are taking actions that have real potential impact without evident clinical support.

mc32 8y ago
At least theranos had real, good scientists doing real research work. Of course we know management went awry [failing to admit defeat and pushing on despite the problems] and threw everyone under the bus, but they had real researchers. This company here from the outside looks closer to quackery. [and can't imagine them having a good team of scientists behind it].
- theli0nheart 8y ago
  Management never "went" awry. The whole thing was a fraud from day one. And hiring "real researchers" to front your fraudulent operation as a way to hide what's going on behind the scenes shouldn't be reason to look the other way. In some ways it's worse than the alternative, since there's not just fraud, but activity intended to take attention away from it.
  - Fricken 8y ago
    It wasn't a fraud from day one, Elizabeth Holmes was a teenager when she got started on Theranos, she had no idea at that time that it had no chance of working. Uncle Tim gave her $200k in seed funding and she ran with it. Shit got progressively more fucked up along the way.
    - SilasX 8y ago
      Yes, and she bought into the “fake it till you make it”, “no one knows what they’re doing”, “all self doubt is impostor syndrome” mentality that’s so popular on this site and which inevitably leads to idealistic people doubling down on fundamentally confused ventures where they should have realized they’re out of their depth.
      - Fricken 8y ago
        Are those attitudes really that popular on HN? Most of the comments I see are pretty cycnical about emerging technologies and longshot bets. The thing is, after she got that $200k in branded VC capital from family friend Tim Draper, Holmes went knocking on the doors of all the big silicon valley VC firms and all the big bio-sciences VC firms. They consulted with blood scientist type people who informed them device had zero chance of living up to it's promise. All of them said "Sorry Elizabeth, we must politely decline your invitation to flush our money down the toilet." The money she did get after that seed funding was from fly-by night wannabe VCs, and the bandwagon effect took off from there. Who did their due diligence? Nobody. I'm not shedding any tears for Rupert Murdoch, but there were hedge fund managers in charge of people's pensions who gave Theranos 100s of millions of dollars without looking into what it was they were spending other people's money on. It baffles me that anyone that stupid can get to be in charge of that much money in the first place.
        asveikau 8y ago
        I think what the parent means is that it is indeed very popular on many tech sites where career discussion occurs to overstate imposter syndrome and imply that solid competence without imposter syndrome does not exist, everyone is just faking it. Imposter syndrome is a real phenomenon and successful people are mere mortals who should not be put on pedestals. But it's possible to attribute too much to these factors. And dishonesty (faking it) should not be where you turn.
        dmix 8y ago
        I’ve been on this site forever and I remember the early Theranos articles were highly skeptical or had as little information about what they were actually doing as this site has primarily programmers and software people, not as much people in bio. Regardless faking state-funded health experiments in a heavily regulated industry has nothing to do with fail fast mentality of the software world either (just like how everyone here criticized that personal banking startup who tried that in the heavily regulated finance industry). We have nothing to defend here.
- twtw 8y ago
  Did theranos have anyone doing real research work? My understanding was that theranos had real, good scientists who were continuously pressured to fabricate results and do quick hacks to keep up appearances. What real research work could anyone have been doing if everyone there was ignoring the fact that their procedures and equipment did not product accurate results?
  - mc32 8y ago
    Good question, I don't know. It's possible they were sent on wild goose chases knowing they were in vain and just a front. I have no idea, but I know they had good scientists in their employ. In any event, research labs have many lines of inquiry and separate teams working on their specialty. I don't know if they produced good IP, just that they had good scientists working for them, and have moved on to other reputable companies since. This outfit singled out by the FDA though, it looks like complete fraud.
    - nradov 8y ago
      Any scientist who compromised his or her ethics by continuing to work for Theranos after seeing how they operated from the inside was not "good", by definition. Their reputations will be stained forever.
      - mc32 8y ago
        Not necessarily. Teams aren’t privy to everything in other teams. It's possible their reps be stained forever, but it's not all deserved. Mgmt can be deceptive. Just because you're an expert in one line of inquiry does not mean you're an expert in another (and can call out fakery, esp if it's kept from them).
      - asveikau 8y ago
        Unethical people can hide it well. They probably also had people at all stages of their careers, eg. imagine a very junior person being impressed with the position, with very little work experience to be able to see through office sociopathy. I am sorry for anyone who now has such a stain on their record after being exploited like that.
- deleted 8y ago
  [deleted]
- newnewpdro 8y ago
  Any scientist/researcher with Theranos on their CV should be viewed as complicit in the fraud, not exempted from it.

transfire 8y ago

I'd rather hear from the people brave enough to have tried this to gain their perspective.

hannasanarion 8y ago
Why do you think that someone who would literally suck your blood out of your veins so that they can live forever would bother to tell you what it feels like? Why are we pretending this is anything but horrifying? We have multiple works of dystopia and horror fiction about this very premise: The Golden Compass, The Waterworks, Get Out, The Supernaturalist, Unwind...
- sanxiyn 8y ago
  > someone who would literally suck your blood out of your veins Blood is renewable. You aren't losing blood you donate (or sell).
- gavrif 8y ago
  https://www.lesswrong.com/posts/rHBdcHGLJ7KvLJQPk/the-logical-fallacy-of-generalization-from-fictional https://www.lesswrong.com/posts/rHBdcHGLJ7KvLJQPk/the-logica...
ggm 8y ago
I don't quite get the intent behind rather here. I too would like to hear from people who tried this, but its not a preference to being told the FDA is clamping down, its just another perspective. Nicotine addicts like taking nicotine irrespective of the 101 toxic chemicals in smoke they get along side it. I'd rather the Surgeon General didn't say "oh well, let them do what they want" I also have views around paid blood and organ donation in general. I think its a bad idea.

succubis 8y ago

Before we start sucking the blood out of the veins of young people, let’s make sure we have all our other compulsory economic transactions eliminated. All the essentials like: - showing up to work - putting clothes on your back - putting food in your belly - putting a roof over your head - having an actual family ...of some kind, not just loose-knit acquaintances that you watch movies, TV and play video games with, not internet friends. People who would do more than share a room with you for the purpose of polite conversation. Then, we can talk about how and why people might open up the faucet, and let strangers tap their veins, when they’re barely old enough to make choices like drink, fuck and smoke cigarettes. We do expect this to be a choice, right? This brokering of blood? Not an option to confront out of financial desperation? Really, though, I’d rather see people grow their own genetically cloned vats of blood, than accept externally sourced transfusions at all. The young blood that enters your veins should be sourced from in vitro repositories, not pulled from people that match your type, but are otherwise genetically distinct. It shouldn’t even come from anliving twin. It should be cloned from your own body.

BurningFrog 8y ago

How can plasma transfusions not have gone though rigorous testing? Has it not been done routinely millions of times for decades? I understand it's not been proven to have any health benefit. But the safety of the procedure must be extremely well known.

ianhowson 8y ago
For a treatment to be granted 'FDA approval', the FDA needs to see evidence of two things: safety and efficacy. Even if a treatment is demonstrated to be safe, if there's no evidence of therapeutic benefit, they won't approve it.
- deleted 8y ago
  [deleted]
- BurningFrog 8y ago
  Yeah, if you parse out the words, that is all they're actually saying. "There is no proven clinical benefit" and "there are risks associated with the use of any [...] product".
  - ianhowson 8y ago
    They're also not saying "Ambrosia Medical must stop administering this treatment". They're just saying "we don't approve". So this thing on the Ambrosia website: > In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments. doesn't quite make sense, because the FDA hasn't publicly asked Ambrosia to stop, and the FDA never did approve transfusions for the purpose of life extension or anti-aging. They're not complying with anything, because that announcement wasn't a 'cease treatments' notice. So we don't really know why Ambrosia has chosen to stop.
- magduf 8y ago
  So why is chiropractic and homeopathy allowed?

DKnoll 8y ago

I think a good enough reason to forbid it would be to prevent companies from paying donors more (or at all) and diverting blood that could be used for necessary medical treatments.

mips_avatar 8y ago
I don’t think this should be allowed as a treatment, if it’s efficacy hasn’t been established. But I wish there were a trial. I want to be able to live healthily to 100.
- rscho 8y ago
  ...by feeding upon material which is already limited in availability for providing treatment to people younger than you are.
- nradov 8y ago
  There is zero scientific basis to expect that this would allow people to live healthily to 100. We have limited resources for clinical trials and those resources should be focused on areas more likely to produce useful results.
  - mips_avatar 8y ago
    I haven’t seen any evidence for it either. But I’d like to see the FDA support aging treatments more. The affect of an extra 10 years of healthy life would be huge.
  - ibeckermayer 8y ago
    And what precisely gives you (or the bureaucrats running the FDA) the authority to decide for everybody in America what is the best use of our blood? I should be free to decide for myself what to do with my own body, and which authorities to trust on matters beyond my domain of expertise. If you have a good argument for why this is a waste of resources then make the argument, don’t legistlatively prohibit me from thinking for myself.

dmourati 8y ago

I'm reminded of the title of a distributed systems post the original appears to be no longer working but here's a HN link: https://news.ycombinator.com/item?id=12245909 https://news.ycombinator.com/item?id=12245909

CaliforniaKarl 8y ago

The company mentioned, Ambrosia Medical, has been on HN before. https://news.ycombinator.com/item?id=14470314 https://news.ycombinator.com/item?id=14470314 From the Vanity Fair article that the above linked to, it seemed it was run by Jesse Karmazin, with Peter Thiel either as a booster, or maybe providing funding? The article isn't clear on that, although he's mentioned (and quoted) multiple times.

rscho 8y ago

For some reason, the only appropriate name that comes to my mind for such companies is "Bathory".

porphyrogene 8y ago
Dr. Acula would like a word with you.

ErikAugust 8y ago

No JavaScript, etc: https://beta.trimread.com/articles/92 https://beta.trimread.com/articles/92

duchenne 8y ago

I am now reading "Red Star" a 1908 utopian novel by Alexander Bogdanov, where another advanced Humanity is living on Mars. In this Utopia, people frequently transfer blood one from another. The author presents blood donation as one of the greatest form of Fraternity. Interestingly, Bogdanov founded one of the first blood transfer institute with only volunteering donors. At that time, most blood donations were paid. Later on, thanks to better conservation techniques, less blood was needed, and volunteering became generalized world-wide. Bogdanov also believed that blood donation could rejuvenate people. His wife said that he looked 7-10 years younger after his experiments. But, in the end, he died, because he received malaria-infected blood. That is interesting to know that some 2019 issues already existed more than a century ago: blood transfer, paying for blood, rejuvenation, etc..

Pristina 8y ago
they are actual non-problems. If you own your body, you own your blood. You should be able to sell or do whatever you please with it. If some people think they can become younger by bathing in young blood, let them. It's their money and time, and blood too, as long as they buy the blood legitimately.
- zimablue 8y ago
  >If you own your body => you own your blood => you can do whatever the hell you want with it > If you own your body you own your hands => you can do whatever you want (murder) with them > That argument doesn't stand, I'm saying you can do anything you want with them that doesn't harm anyone else > Interesting, what's your definition of harming someone? If I control all the mechanisms of law and create a situation where every other person is effectively my slave (eg. I own all the land), then where in your libertarian philosophy do we fight that? Or do we just accept it? I'm telling you with love in my heart, that taking a simplified libertarian view of everything is an intellectual trap and the world is way, way more complicated economically and philosophically than can be managed through libertarianism. In the same way that gender politics gets disproportionate airtime because 1. it's very feel-good for groups of girls to feel united over and get a thrill of moral superiority from, it works socially 2. it's something for the elites/rich people to focus on that isn't redistribution or reform Libertarianism gets press because: 1. People love having a single rule for things, because it makes them feel clever and right often without having to do any actual thinking. And it's clever on light inspection and dumb on deeper thinking 2. see gender politics 2.

jfultz 8y ago

It's like the company used Normal Spinrad's "Bug Jack Barron" and the goofy sci-fi premise invented by its mustache-twirling villain as an operating manual.

kkarakk 8y ago

Has there been any research on what happens when you pump "old-blood" into young people? any gains in wisdom/maturity/dementia?

jokowueu 8y ago
On mice only

kfwhp 8y ago

Are there any actual, proven benefits to these blood transfusions, or are they just something rich people like to do for the sake of it?