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A Shady Trial?

The “young blood” research field is moving right along, but there are reasons to wonder about some of the directions it’s moving in. I’m referring, of course, to the results that have shown profound effects of younger plasma on older animals, and the big question is what the effects are on older humans. The Stanford group who reported the original results have started a company (Alkahest), and they’re starting an exploratory trial in a small cohort of Alzheimer’s patients. But there’s another trial in the works, although perhaps I should put that word in quotation marks.

Here’s more: a company called Ambrosia is signing up 600 patients 35 or older, running them through a battery of tests, and giving them a one-time infusion of young plasma. It will cost you $8000 to participate in this, which makes the whole thing seem suspiciously like a profit-making enterprise, and the design of the study makes it hard to say what’s going to be learned. There’s no control group, and the patients are apparently going to be a pretty heterogeneous bunch. The one thing they’ll have in common is that they have eight grand to spend.

There’s a lot of junk like this out there – the stem cell field, to pick an egregious example, is littered with semi-sorta-trials that you have to pay for, and this stuff makes it hard to figure out what’s actually going on in the field. Clinicaltrials.gov is a good idea, but there are times when it could really use more curation. Or perhaps there could be two levels of it – the “anything you want to throw in there” one, and a curated one? There should at least be a notation about the patients being the source of funds for the trial (which should be a red flag, in general).

There’s a saying in the writing business (Yog’s Law, coined by author James MacDonald), that “money flows towards the author”. An “agent” or “publisher” that asks you for hefty fees or upfront money for what’s supposed to be a commercial work is almost certainly a scam – publishers actually advance money to authors, because they expect to make money on the finished work. And in the same way, biopharma companies expect to make money off the fruits of their work, so if someone is charging patients big money for what’s supposed to be a clinical trial, something is off. And something certainly seems to be off with Ambrosia and their plasma study.

35 comments on “A Shady Trial?”

  1. anonao says:

    Any proof that the trial is run properly? Would be expensive at $8000 to get a dyed saline

  2. exGlaxoid says:

    The compounds in plasma last a few days at most. Even if it were a wonder drug, the effects would not last long, and you have the risks of getting some new disease from a transfusion. Older people would do better to get the whole blood transfusion and at least get some red cells, which would have a slightly longer positive effect. Note, if you are an athlete, blood doping may be banned…

  3. Rule (of 5) Breaker says:

    I guess with the existence of pseudoscience, pseudoclinical work was to be expected – *sigh*

    This goes along with all the supplement commercials I see that are “clinically tested”. Not clinically “proven” mind you, but at least they tested them.

    1. John Dallman says:

      I suspect it’s really an attempt to commercialize confirmation bias.

  4. Peter Kenny says:

    I have to agree that this is not entirely convincing. It would help if they could show that the off-rate was slow or, at least, that binding was enthalpy driven. They really need to demonstrate high ligand efficiency and thermodynamic proxies would also be helpful here.

    1. anonao says:

      Did a metric person take your partner plus the dog/cat and the house?

  5. SedatedFMS says:

    Sounds like a snake-oil salesman has rediscovered parabiosis experiments and decided to cash in.

  6. AmILloyd says:

    What’s next? Newt blood transfusion trials?

    1. Ted Cruz says:

      Nah, Gingrich has no blood to spare.

  7. Slurpy says:

    That’s a pretty terrible charge. I participated in a Phase III study for an intraocular lens implant, and it cost me about a grand. The company (Alcon) donated the lens, the doctor conducting the study donated his time, but I had to pay for the anesthesiologist and the surgery room. At $8K, it almost sounds like the patient is just paying to beta-test the therapy.

  8. CFaulk says:

    I wonder if everyone’s favourite anti-aging “guru” Peter Thiel has a stake in this.

    1. Derek Lowe says:

      He is very interested in the field, from what I understand. . .

      1. John Travis says:

        Actually Thiel reportedly expressed interest in this specific trial (Inc reported that which is why Jocelyn pushed her story out the same day)

  9. roger says:

    The hubris is strong is these guys: Alkahest – the alchemist universal solvent; Ambrosia – the food of the gods. Perhaps Nemesis is about to come calling.

  10. Anon says:

    Has the effects of this on rodents been independently reproduced, or is this one of those “one lab, one paper” findings?
    To create a startup and tap patients without independent verification of the cornerstone academic findings borders on criminal.

    1. lazybratsche says:

      The basic heterochronic parabiosis findings have been replicated by a handful of labs over the course of several papers. I’m pretty well convinced that the effect is real, at least for mice. Stitch together a young and an old mouse, and several age-related problems will improve in the older of the pair (or at least will stop getting worse).

      However, the mechanism is unclear. One of the original hypotheses was that circulating stem cells in young animals would help maintain and repair old tissues, but that hypothesis has been all but eliminated by the evidence. There are some candidates for specific circulating factors that might contribute to the effect, but the science there is extremely preliminary (and in my opinion, compromised by the all-to-common problem of useless antibodies and reagents).

      And without a mechanism, there’s little reason to believe this will be translated to humans any time soon. A few plasma transfusions are simple and low-risk, but I suspect any positive effect would require impossible treatment frequency.

  11. CFaulk says:

    They appear to be monitoring at least 110 blood biomarkers for changes 1 month after transfusion.

    My Prediction: They find one or two (or several) biomarker changes for which p <0.05, link them to a loosely established medically relevant phenomena, tout it as "groundbreaking" " a game-changer", "a new era of aging science", set-up shop in a mind-blowingly expensive clinic in the Hamptons, and watch the cash flow in.

    1. Phil says:

      Obligatory xkcd strip linked in my handle.

  12. anon the last says:

    Clarke’s first law – When a distinguished but elderly scientist states that something is possible, he is almost certainly right. When he states that something is impossible, he is very probably wrong.

    Clarke’s second law – The only way of discovering the limits of the possible is to venture a little way past them into the impossible.

    Clarke’s third law – Any sufficiently advanced technology is indistinguishable from magic.

  13. oldnuke says:

    And if the person selling this just dropped out of Stanford and is wearing a black tutleneck, be very, very suspicious!

  14. dearieme says:

    Monkey glands!

  15. I’m sure the blood will be carefully tested…with the latest equipment from Theranos.

  16. Uncle Vlad says:

    Agreed that $8000/person trial is probably a scam. And I understand that people are looking for some “eternal youth” factor in young blood which could be isolated, patented, synthesized and sold.

    But let me ask a question about commercialization and return on investment from a slightly different angle:

    Suppose that there is no magical component which can be isolated, patented and commercialized, but in general, this whole “young blood” thing works out. For the sake of argument, say that after a long and expensive clinical trial we discover that for an average 50-year old, plasma (or whole blood) transfusion every couple months delays objective signs of aging (mental, physical, whatever) by a month. So, … it works: as long as you are able to pay for transfusions, you can very significantly delay aging and death. There are plenty of wealthy folks willing to pay, and there are plenty of young folks willing to donate for a fee.

    But this would be a lengthy and thus an expensive trial. How is any commercial entity expected to recover costs for such a trial? Even if you secure a patent in US or EU (for a blood transfusion? really?), transfusion clinics work just fine in Kinshasa, Kathmandu or Tomsk. It seems to me there is no way to recoup the cost of clinical trial.

  17. Barry says:

    Fear sells, and the fears of aging and death are perennial favorites. A hundred years ago, men were paying to have goat or monkey testicles implanted in their scrota. More recently some have been using growth factors (hGH, IGF-1…) off-label, and Geron spent years trying to extend teleomers in somatic cells, all to hold off the effects of aging.
    But until the FDA defines aging (or geriatric frailty) as a disease, none of these “therapies” can get approved where there is no disease. That rules out the usual players and cash streams for drug development, and leaves the field largely to dreamers and charlatans

    1. Derek Lowe says:

      Dr. Brinkley! I count him as a fellow Arkansan. . .

  18. Insilicoconsulting says:

    So the vampire lore does have merit! What we got wrong was that their fangs were built to isolate the plasma …

    In the same vein, are the elderly treated mice sensitive to sunlight?

    In general I agree with Uncle Vlad.

  19. Anon says:

    I wonder if the total extension of life exceeds all the time you will spend sitting waiting in a clinic or hospital having all these transfusions. I would rather be plugged into the Matrix, at least you have something else to do and think about during all that wasted time.

    1. Anon says:

      PS. If we could only spend more time enjoying life, we wouldn’t waste so much time worrying about how to extend it. Sad. And to charge for this scam? Those people should be shot – the victims as well as the predators!

  20. Anon says:

    Another reason to have children.

  21. Isidore says:

    This has all the markings of yet another dystopian future novel/movie, in which people are bred to be exsanguinated for the benefit of a forever youthful elite. Kinda like this:
    https://en.wikipedia.org/wiki/Jupiter_Ascending

    1. tangent says:

      It really does. I kind of want a paper to come out that quotes a regimen that shows an effect, so we can start working out the structure of our future society.

      What volume/time dosage rate does it take, and what’s that as a multiple of the plasma production rate of one source human? So X active lower-class sources is what we need for each of us middle-class people. If sources are tapped in the 18-27 age range, then they are productive for 1/3 of their lifespan, so we need 3X sources. If they are almost all female, then each needs to reproduce once in her lifetime to replace herself, but of course you need some surplus reproductive rate to work with…

  22. Alexander says:

    Huh. For me it just looks as they’ve found this Wikipedia article: https://en.wikipedia.org/wiki/Alexander_Bogdanov
    Stealing the ideas from our Russian Communists again, them capitalistic pigs, eh? At least Bogdanov was not trying to make money off the research subjects…

  23. tangent says:

    WTF, you can do that, charge the subject of a clinical trial? Have I been naive! Can you get that past an IRB, or is this for studies that don’t have any grown-ups watching?

    I could imagine how this would happen for an orphan med, if there’s no funding to be found (but it’s still a bad way to do things), but it seems total crazypants for you to pay to add value to my for-profit company’s intellectual property. Dr. Lowe nailed it with the Yog’s Law argument, it strongly suggests my company doesn’t think the treatment is worth anything.

    1. Agrippina says:

      You can charge subjects for a biologic in an IND trial with written permission from FDA after they assess the proposed charge. Although the study registration indicates it’s regulated by FDA, it seems unlikely that FDA would agree to the $8K charge, and the protocol “design” makes me wonder if an IND was submitted.

      Study registration identifies PI as Jesse Karmazin M.D.
      https://clinicaltrials.gov/ct2/show/NCT02803554?term=young+plasma&rank=2

      I can’t find a CA medical license for this physician; there is however a MA medical board voluntary agreement not to practice, which inter alia requires the physician to notify the DEA Boston Diversion Group: http://www.mass.gov/eohhs/docs/borim/board-order/vanp/vanp-j-karmazin.pdf

      Taken together it makes me suspect there is a *lousy* IRB out there that approved this “trial.”

  24. dlr says:

    I haven’t even seen a study showing that mice experience health benefits/increased longevity from transfusions, let alone human beings. I’ve seen the studies where they experience health benefits from parabiosis, of course, but that is a SYSTEM, and not a static one — signaling molecules of all kinds are undoubtedly going from the elderly mouse to the various organs of the younger mouse, causing them to pump out all sorts of things into the bloodstream to deal with the problems the elderly mouse is experiencing. The young mouses organs have taken on the job of attempting to maintain homeostasis, not only for itself, but also for the elderly mouse, whose various organs are no longer capable of doing so.

    There is no guarantee that any of those molecules exist in the bloodstream of a young mouse that is simply ‘donating’ blood and who isn’t experiencing the health challenges of dealing with whatever is in the bloodstream of the elderly mouse.

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