To you or I that might make sense, but once a drug becomes generic the pharma companies stop all marketing and investment in the drug. I think the rationale is that while it might provide a bump in revenue (for a clinical study like this), most of the benefit will go to the generic drug companies, that capture probably 90% plus of the market once it goes generic.
And the $400K trial is not going to provide the type of data that would boost sales. For a sales boost you’d need the $40 million clinical trial like the TAME study…
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AnUser
#123
My point is that they are expected to make their money back, and more. It isn’t high effort to write two checks either. That generic companies benefit as well doesn’t matter IMO.
I don’t think it will cost millions of $ to get an adequately powered trial. They already have 40 participants for $400 k.
But I don’t think Pharma (or the FDA) would look at a small study like this as being of much help, or have any significant impact on sales… the ROI would be very poor from their perspective. They really want a significant clinical trial to get the data that really helps… such as provide by a phase 3 or phase 4 clinical trial - and they are just very expensive. See below for examples of costs:
Table 1: Total Per-Study Costs (in $ Millions), by Phase and Therapeutic Area [a]
https://www.sofpromed.com/how-much-does-a-clinical-trial-cost#:~:text=As%20general%20rule%20of%20thumb,%2441%2C117%20per%20patient%20[2].
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AnUser
#125
It’s not going to cost that much, as evident by the fact that this trial will cost around $500k for 40 participants. You double the amount two times, and you have 160 participants for $2M. It’s peanuts and if they show Rapamune to improve muscle performance and strength in elderly, I would bet that interest for rapamune would be much higher. For every person convinced by the protocol they’re taking 288 mg of rapamune a year close to $1000.
If 1000 people in Europe + Turkey, out of 700 million people start taking Rapamune they’re making $1M a year. (back on the envelope), that’s a very conservative number.
Have you ever done any work with Pharma companies? In my experience they are extremely conservative groups… they focus exclusively on the high margin/patent protected molecules, and really have no interest in doing anything once a drug goes generic. I agree that a case can be made, but I just don’t think it would be of interest to them. If and when they decide to target aging, they will do it with patented molecules that they can charge high prices for, and get the 90%+ gross margins that they are used to.
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Sure he does. They’re consistently all linked in the notes to his YouTube videos.
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It’s dirt cheap as trials go — but that comes with limitations. You can have cheap or adequately-powered — not both. As others have indicated, you run pilot trials first to convince donors of plausibility and feasibility.
EVERLAST is a real bright spot in that regard. It’s by far the most ambitious trial of an anti-aging agent that’s ever been run, and it’s on the bold side to be doing it with a rapalog and not metformin, an NAD precursor, or some other benign-but-useless shiny object.
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José
#129
FWIW
The proposed TAME study cost was estimated at $90 million{per Nir
Barzilai] He had $35million committed, still trying to raise the rest.
It is 3,000 people in multiple centers.
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But they’re unlikely to make their money back, for the reasons RA just gave. And in a capitalist system, the opportunity cost rules out investing X dollars just to make X dollars back — and it’s actively counterproductive if it means that your competition will make nearly-X dollars at no cost to them.
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AnUser
#131
I just showed a scenario where they would invest $2M and make a $1M return every year, hard to find a (small) opportunity like that for very low effort, just write the check. Only problem it would remove sales for a future proprietary anti-aging product, lol. The generic companies making some money is from some people ordering Indian rapamycin to the U.S, or the American market in general. The EU is mostly Rapamune AFAIK. You’re not thinking about every market.
1000 people taking Rapamune in EU for anti-aging is a very low estimate from a positive rapa/muscle aging trial. It’s probably much higher than $1M a year. Also wealthy users would probably prefer Rapamune over generics, and is a large customer segment.
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You are right… its our best bet right now for good data. But - with 86 people, its still a pretty small clinical study by pharma standards. Data seems likely to be available in 2027 or perhaps 2028.
And @AnUser I think the issue fundamentally may be that for whatever small clinical trial you are talking about… its not going to get the FDA to authorize a new indication (e.g. anti-aging, or sarcopenia) based on that one small trial. So the drug (rapamycin) will still be stuck in its “off-label” status, and the mainstream doctors (and regulatory agencies around the world) are not going to suddenly adopt / allow rapamycin to be prescribed by family physicians.
The argument might be that pharma companies sometimes support smaller clinical studies to test in some off-label application, without seeking a “new indication” to be formally accepted by the FDA, but that is likely for a drug that is already being used by a given type of doctor, and for an application in a somewhat closely related area. Rapamycin is very different - its a “black box warning” drug used by a small fringe of doctors (who treat transplant patients), and a new area like muscle wasting (sarcopenia) - so an entirely new group of doctors and new patients.
The question we have to ask is what sort of trial would be enough of an impetus for classical medical doctors in the mainstream system to start prescribing rapamycin for longevity. I think that bar is very high - and likely even higher in Europe (I suspect).
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AnUser
#133
That’s not a couple thousand user drugs, that is a multi-billion dollar drug. I was speaking from off label use and people being interested in the drug just like now, but a couple thousand more users, still I think they’d be making money by funding Rapamune trials. But maybe they’re going for the big bucks and the big bucks only.
I suspect pharma doesn’t even look at drug opportunities that don’t meet $100 Million/year revenue, and 90% gross margin hurdles.
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You speculated such a scenario, yes 
. You are also neglecting the risk that it might fail, as the great majority of drug candidates do.
First, the generic market is much larger than people who would go to the trouble of ordering from abroad: the main contenders are legally-sold, regulated sirolimus generics in US and European pharmacies. I don’t know what the market shares are for rapamycin, but generally generics have higher sales than the originals for cost reasons. And the economics are worse, not better, outside of the US, because the unit sales prices are lower.
Peter Attia is a real MD. He graduated Stanford Medical School and did surgical residency at Johns Hopkins and fellowship in Oncology at National Cancer Institute. But, after his training he went into management consulting and now he is a businessman. Supposedly he still sees patients as part of a very expensive concierge practice.
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AnUser
#137
No I did, that’s what I meant with expected value. If there was no risk, it would be a lot higher than $1M.
On black market in EU there is only Turkish Rapamune, so I don’t think there are any generics for rapamycin in EU.
José
#138
Jacob_F, did you read his book?
Attia states he quit his 7 residence after 5 year{such as never finished] and left medicine. Did not have any practice other than 5 year in training.
Then moved to Palo Alto California, got a job at McKinsey & Company.
Left McKinsey & Company, started “Medicine 3.0”.
In my view partial "surgical residency " has nothing to do with “Longevity Medicine” training.
It is just as much effort to sell a $500 product/service or a $160,000, product/service, he is a good salesperson, selling to people with high net worth.
Selling the sizzle, the smell, closing the sale and the person paying for the steak.
Who cares? He has full medical training and is a licensed physician. Even if his training in research and longevity medicine is self-taught (and taught to him by his many brilliant researcher friends and colleagues), again who cares? I care about the content of the information he shares, personally of which I find the vast majority useful, rational, and based on solid published data. Calling him a salesman and complaining about his fees just seems like a weak attempt at a smear.
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I think we are in agreement. I was drawing a difference between Dr Stanfield and Dr Attia. Both are licensed medical doctors. One left medicine and created a very lucrative business career for himself. The other gets up every morning and goes to the clinic to care for a wide diversity of patients.
Personally, I like Peter Attia’s content, but I take him with a grain of salt. He is curator of information on the field of aging, not a first hand expert. He has interesting perspective and I value the way he presents information.
Dr Stanfield is also a curator of information, not a first hand researcher, but I pay him specific respect as a passionate doctor with first hand experience treating patients. I would accept (and have accepted) medical advice from Dr Stanfield, whereas I would simply get ideas from Dr Attia and then consult a practicing physician when making a decision about my own health.
Incidentally, another MD among the pundits is Dr Alan Green. Alan is a pathologist, by training and experience, so I keep that in mind when consuming his advice. What I like about Alan is that he is at a stage of life where he has nothing to prove, except that he still has all of his marbles and he is a caring person. I got a particularly valuable insight from him that my own doctor had overlooked, so there’s another data point for taking input from multiple sources.
And lastly, I would add that even the bench scientists are often selling something. Academic scientists have to hype their work to compete for grants and academic standing. They also are often consultants to companies making products. They will typically share their conflicts of interests when publishing papers or presenting at academic conferences, but they leave often omit those references when posting youtube videos.
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