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FDA warning brings young-blood transfusion company to a halt (techcrunch.com)
120 points by mips_avatar 30 days ago | hide | past | web | favorite | 89 comments



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..


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.


Be careful what you wish to turn into a commodity because in increasingly deregulated capitalism there is often no way back.

That would be yet another way to increase inequality.

Do you really want to force people to pay down loans with blood, skin and kidneys? Because that will inevitably happen if allowed.


I can see issues with the widely available market for blood donors, but I disagree about "paying down loans with blood, skin, and kidneys".

If you do physical work you already destroy some muscles, and if work is stressful you destroy your kidney trying to get relief by drinking yourself out. The skin on your hands also gets damaged from hard work. Or skin on your body after constant exposure to the sun.

We should strive for a society where we do not have to work ourselves out to pay off the loan, and not focus on preventing people from paying off loans destroying their bodies specifically, no matter if it is blood donation, or herniated disks, or destroyed lungs, or anything in between.


> We should strive for a society where we do not have to work ourselves out to pay off the loan

When we have such a society we can reevaluate. But right now we don't, and in the current environment creating more ways for inequality moves us away from such society.


I think it is a problem if people or companies are advertising a non-existent or unsubstantiated medical benefits of a procedure.


>I think it is a problem if people or companies are advertising a non-existent or unsubstantiated medical benefits of a procedure.

Ok, now this sentiment I don't understand at all.

Here in America (and other countries), we already have *entire "medical" fields" which consist of nothing but claims of unsubstantiated medical benefits. Chiropractic, Homeopathy, Acupuncture, TCM, etc. are all unscientific and make all kinds of claims with no evidence whatsoever, however the FDA allows them to operate with impunity, and even serious hospitals have these practitioners in them as "ACM".

But now they're going give a hard time to a company for doing something similar?

Seriously, I have a much easier time believing that maybe, just maybe there could be some health benefits from getting blood transfused into you from a really healthy person, than I would ever believe that 1) any ailment you have is caused by "subluxations" in your spinal column or that 2) someone can test if your body "needs" some "supplement" by pushing down on your outstretched arm while holding it in front of you or that 3) you can be cured of something by ingesting highly purified water.


Those things are are all regulated and get a hard time. They are not "medical" fields, and none of them operate under the license of "medical doctor". Dangerous ones are banned, and ineffective ones are required to carry a disclaimer.


They certainly are "medical fields", because that's how people treat them, and they promote themselves as viable alternatives to real doctors. Even worse, many hospitals actually have them there practicing; they call it "alternative and complementary medicine".


I don’t think I’m suggesting a double standard. I don’t know much about any of these fields but I think the standard should be the same.


>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.


Are there examples of something that you're allowed to do as a volunteer, but not allowed to get paid for it? Sex in some states I guess. What else?


Work


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.


I mean plasma products aren’t zero risk. But yes pretty low risk. One of the problems with FDA approval processes are that they wont approve anti aging trials. Because basically the FDA only allows you to treat a problem and it doesn’t consider aging to be a problem. https://www.politico.com/agenda/story/2017/12/13/anti-aging-...


Wouldn't you just need to go one step further? Aging isn't a problem, but macular degeneration, or erectile dysfunction, etx from aging is a problem, so you can treat that.


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.


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".


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.


Aging is the an FDA approved disease, but every symptom of aging is.


So why is chiropractic and homeopathy allowed?


I can't speak for chiropractic as that's out of scope for the FDA and I have no knowledge of the regulatory process there.

Homeopathy and supplements are classified as food, not medicine. Therefore, they're not required to seek FDA approval. (They still have to meet food safety standards, of course.)

If they could do anything meaningful, they'd be required to reclassify as medicine and undergo approval.

So you get this fun situation where anything useful is locked up and can only make very specific claims about what it can cure. The things that can't cure anything can make weasel-worded claims about anything.


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.


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].


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.


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.


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.


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.


Every time I bring up the impostor syndrome overdiagnosis and “no one knows what they’re doing” meme in the context of Theranos, the replies take umbrage at the reference, and insist that HNers and VCs in SV saw through Theranos the whole time.

Which is true! But also, very beside-the-point.

The point is, that some people really are impostors. Some people really don’t know what they’re doing, in a much deeper sense than the usual “oh I struggled over a judgment call yesterday while doing 90% of my job the routine way”.

From the inside, it’s hard to know whether you have excessive self doubt, or you’re an Elizabeth Holmes. And it’s a pretty freaking important distinction to make.

The HN/SV mentality I’m criticizing is the one that jumps straight to “oh that’s impostor syndrome” rather than giving concrete tests for whether the self-doubt is justified. Who swears that every expert engineer, manager, and businessperson occupies the same epistemic state that Holmes felt, who equates the occasional judgment call with knowing nothing about the core problems of the domain you’ve entered.

So yeah, you called Theranos early on. Good for you!

Now, for your victory lap, stop telling the next 100 Holmeses to double down on their “faking it” on the way to the inevitable “making it”. Help them determine whether they’re a Holmes or just worrying too much.


There's a HUGE difference between self doubt and others peoples doubting you. One is inflicted on our self without evidence while the other is inflicted by others, often with evidence.

Impostor syndrome is caused because you believe you aren't good enough, but how can you know that when you are still new in a domain? Why would someone that better in that domain would pay you to works on that? Because he has evidences that suggest that you can do what's required in that job.

Now if experts tell you that your idea already exist and doesn't works for X, Y, Z, it's no longer self doubt.... it's actively ignoring evidences.

> So yeah, you called Theranos early on. Good for you!

Which make it no longer a self-doubt.

Faking until you make it was never about faking results or evidences, it's about faking confidence. Confidence is a great motivator, it's a great way to push beyond, but it doesn't replace real evidence.

The real issue here is that theses VC didn't require more than confidence to invest that much money. The fact that plenty of expert called out that scam early on show how an easy due diligence weren't done correctly.


Thank you!!


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.


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.


Yeah, prediction is really hard and even here on HN people sometimes don't see the value of a good thing, as in the case of DropBox etc.


I'm going to take a bit of a different tack on this. I've worked in a lot of startups and never once have I worked in a company where the founder knew what they were doing from a technical sense. I'm sure they exist, but they aren't common.

What most successful founders are good at is running a business. However, I'll be really clear on this: there are 2 necessary things without which you will fail. First you need someone on staff that does know what they are doing. If you are good at recognising that person, then you've got some potential to be a good founder. Second you need to be flexible in your vision. Because, as founder, you probably don't know what you are doing.

One of the best companies, in that regard, that I worked at was Corel. Michael Cowpland was an engineer, but I've talked with him a few times and I'll just say that I've never been that impressed with his technical grasp of the situation. However Corel's first product was a SCSI card. It failed. Then they built a graphics card. To go with the graphics card they made a graphics demo. That demo became Corel Draw. Cowpland had a great ability to know when the spaghetti was sticking to the wall (and he threw great gobs of the stuff against the wall, let me tell you!). They just dropped everything and poured everything into Draw. Great move.

The "fake it till you make it", in successful circles, means to stall long enough for your development team to actually build something you can sell. Now, I will say that committing fraud as a way to stall is a stupid, stupid move, but not something I haven't seen before. One place I worked at we were late to demo our product at a show, so we bought the competitor's product, stuck it under the pedestal and then wired it up through an empty box which was supposed to be our hardware. People were astounded at how quickly we had caught up to the competition! BS stuff like that happens all the time and especially if you are young, it would be easy to think "Oh, everybody is doing it. It will be alright. We'll succeed before anyone notices".

I don't know enough about Theranos or Holmes to say anything intelligent, but being a founder is a very different job than being a developer. What I lovingly refer to as "blowing sunshine up everyone's ass" is a big part of the job. Your core competencies are really different and have to be geared more towards evaluating people rather than evaluating things. At the same time you have to be an anchor of calm in the middle of chaos, because if you start to freak out, then everybody else will to. A lot of the advice given to founders can easily be misinterpreted when seen in a different context and I think that may be what's frustrating you. Having said that, being an entrepreneur is a career that attracts more than it's fair share of people who are not suited for that career...


Not to imply that Holmes only faked it as much as the other examples you mentioned, but it's also different significantly in the fact that she faked it in a field that demands regulatory approval and is that much closer to being limited by the laws of nature than a pure software company. You can maybe fake it but at the least you should be smart enough to know what's physically possible and what's not.


There's a difference between faking a computer graphics tool and a product that people's health actually depends on. These industries should (and fortunately, do) have different approaches to risk-taking.


This is such a great post and summary, thank you.


> Shit got progressively more fucked up along the way.

Okay, but the biggest reason for that is because Holmes and Balwani are sociopaths[1]. I wanted to point this out because I feel like your comment is defending her somehow by way of naiveté. Their actions are indefensible on so many levels, from very early in the company's history.

To the grandparent's point, there were people working there in earnest on research. They often did not last long, or, in the case of Ian Gibbons, was driven to suicide by the stress of potentially revealing Theranos's faulty technology in a court case, or lying and hurting patients [2].

Be sure to read "Bad Blood". It was a very good read about this company and Holmes.

[1] - Yes, this label is overused, but not in this particular case.

[2] - https://en.wikipedia.org/wiki/Ian_Gibbons_(biochemist)


She was almost 20 and was told repeatedly by her professors at Stanford that they don't think it would work. If you don't know by the time you're 20 that using off the shelf machines to do blood tests and telling everyone that you're using some new revolutionary method is fraud, then I dont know what to tell you. And no she didn't start with 200k, she had 6 million in venture capital the very year she started which ballooned to over 400 million.


The first investment in Theranos was 6 million dollars? No. She started with $200k from a reputable venture capitalist and that's all it took to get the ball rolling. Nobody was pointing a gun to the heads of the people who invested in Theranos. They were just idiots, is all.


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?


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.


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.


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).


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.


Any scientist/researcher with Theranos on their CV should be viewed as complicit in the fraud, not exempted from it.


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


On mice only


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.


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.


...by feeding upon material which is already limited in availability for providing treatment to people younger than you are.


I am a layman so I could be totally misinterpreting things, but based on existing research it seems like the most effective method would be to filter out or suppress the production of VCAM1 which is apparently a protein that is associated with aging effects. It will be interesting to see how the research develops over the next couple decades.

https://www.leafscience.org/the-fountain-of-youth-could-be-c...


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.


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.


There are things that are a public necessity and indeed collectively-enforced rules simply because they won't work if too few people agree to it.

Another example of this process is vaccines. If herd immunity is too low, then vaccination cannot work, although it is a perfectly good solution if everyone is on board.

A second point is that you probably are no expert on the topic of human plasma. This could motivate the enforcement of rules under certain circumstances, given that you are unable to personally judge if the use of such precious material is a waste or not.

I personally, think that your opinion is the epitome of selfishness.


It is true that not all vaccinations work 100% of the time and that herd immunity helps protect the people for who they have not worked. It is very, very wrong to say that this means that "If herd immunity is too low, then vaccination cannot work".


Oh yeah? Please expand on this, I'm curious.

If that is your point of contention, you could replace "cannot work" by "may do more harm than good at a social level".


I don't know what to expand on, as I don't understand how it wasn't clear from what I have already told you - can you indicate roughly where I stopped being clear?


You mentioned I said something very very wrong, but it's not clear to me if this is a language or fundamental issue.

For instance if I say, as I have tried to enunciate above, "if herd immunity is too low, vaccines may do more harm than good at a social/epidemiologic level", does that still seem very very wrong to you?

To be clear, your above comment gave the impression that you thought that a low herd immunity could not increase deaths due to disease compared to no herd immunity at all, which is wrong and was probably the reason why you were downvoted.


> There is zero scientific basis to expect that this would allow people to live healthily to 100.

Not quite zero. There is at least some evidence that it might treat Alzheimer's disease. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950663/


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.


For what it’s worth, it’s my understanding that they’re ‘only’ transferring plasma which other companies are already paying people for.


Given the limited availability, some (and I hope, many) would consider that limiting the use of blood products to research and proven clinical settings would be the correct moral stance.


This reminds me of all the people who say that it's morally wrong to spend money on going to space when there are still problems down on Earth. It's not a zero sum game.

If people find commercially viable uses for blood, it might result in the available supply being boosted greatly.


Rejuvenation of senior citizens by feeding on younger citizens who are part of the workforce is a "zero-sum game", whatever you think the future will be made of.


That’s the thing: it isn’t.

The amount of blood which could be donated is finite, yes. But it is also far, far greater than the amount which is donated.

Also, it is possible, if unproven, that the benefit to seniors is great, while it is known that the cost in health of donating blood is minimal, and may be beneficial. That, too, would be positive sum.

You want to call it creepy and vampiric? I admit, that’s how it strikes me as well.

But you didn’t say that, you said it was zero-sum. Not so.


And I assume that all the problems stemming from the increasing life expectancy are also positive sum? And planning to do so based upon no established scientific grounds by making the younger population contribute by submitting to a non-zero risk procedure.

You can look at it every way you want, maintaining the elderly population is certainly not a logically positive thing in a ressource-constrained environment. And by ressource, I don't mean blood. That we have morals (which is good) does not make it good from a general logical point of view disregarding social ties.


What’s wrong with keeping old people healthier? We already spend a huge amount of resources on it by way of the medical system, by the way.

Or are you just saying that there are too many people, and think we should have fewer?


And if people start using blood for quackery, it could reduce the available supply the moment something goes south.


“correct moral stance?”

What if the gov puts in place a simple regulation, like “X% of all harvested blood must be donated to local blood banks”. Now you have a market for rejuvenating blood, AND more blood available to hospitals. Only downside is an increase in price for Peter Thiel.

I’ve noticed taking such a moral stance tends to limit creative thinking around such topics (why spend time thinking about it when you’ve already dismissed it as immoral?). A bit of creative problem solving can sometimes turn a potentially problematic situation into a net positive for everyone.


Oh, and how exactly does that provide more blood to hospitals?

Edit: Ok, now I see what you mean. I do not agree with you, although it is a matter of opinion. My opinion is that there are more important social priorities than making rich old geezers live longer and that your plan depends on numbers that could go one way or the other. You could easily build a scenario where your plan decreases hospital blood availability, and this seems likely to me given the financial incentive.


If your concern is that it will reduce the supply of blood to younger people who currently use it then this is something that can be solved with incentives in a way that everyone benefits (e.g. people using it for rejuvenation pay more to subsidise higher production and are a lower priority when there is insufficient supply in the emergency room etc).

If on the other hand, that is just an excuse because you're morally opposed to old rich people living longer... ?


I don't really see how you provide incentives that go the way of blood to the hospital without paying donors that explicitly donate towards that goal more than those donating for rejuvenation.

Right now, we don't have enough just for the people in the ER. Not saying it can't work, but it seems to me that the potential for catastrophic failure on a social level is quite high.


Then you increase X until the problem goes away.

Your thinking on this is a bit short-sighted. Right now, this might only be available to “rich” old geezers. With test-tube burgers already under development, it seems likely that test-tube blood isn’t much further off. By the time you are an old geezer, blood will be a cheap commodity. But only if we get started on the problem now, instead of shooing people away with moral scare-mongering.


One of the things democracy struggles with is balancing the interests of the rich against the interests of everyone else. Because the rich have far more time and money to spend on persuading others to vote against their interests.

Relying on a partially captured government to set the right price is dangerous in this case.


Yeah, so this again is a matter of opinions, but since you are relying on assumptions about the future, I would say that test-tube blood is probably much further away than you think it is.

So I prefer to rely on verifiable present-day fact to decide on socially critical issues.


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


Dr. Acula would like a word with you.


The company mentioned, Ambrosia Medical, has been on HN before.

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.


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.



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


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?


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


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.


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...


> someone who would literally suck your blood out of your veins

Blood is renewable. You aren't losing blood you donate (or sell).





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