We need a major rapamycin trial similar to TAME using metformin and rapamycin. We should not be toiling in the shadows, a major rapamycin trial is what is needed to prove the benefits of rapamycin. Either the drug works to benefit humans or it does not.
How is this process started? How do we find or develop a team to start a trial for rapamycin and mnetformin?
Where and who are the people who will make this a reality ASAP?
What organizations need to be brought in to make this happen?
More information on TAME can be found here:
The Targeting Aging with Metformin (TAME) Trial is a series of nationwide, six-year clinical trials at 14 leading research institutions across the country that will engage over 3,000 individuals between the ages of 65-79. Wake Forest University School of Medicine will be the coordinating center. These trials will test whether those taking metformin experience delayed development or progression of age-related chronic diseasesâsuch as heart disease, cancer, and dementia.
One problem is being a control in such a trial. One good point about XPrize is that they intend to have a control set of data that is a control against all of the teams entering the XPrize.
If you are not aware, the TAME Study proposed at 3000 subjects at 10 centers cost is over 90 million. Nir Barzilai has been trying for year(over six years) to raise the money required. Still has not been able to raise the entire amount.
Personally I think the issue is more one of facilitating the more general prescription of Rapamycin for general health improvement. The evidence is that intermittent Rapamycin is not harmful and there is considerable evidence for an improvement in mitochondrial health. Hence it should be a no brainer for it to be prescribed.
There have been enough trials as to the safety of Rapamycin.
I do have some practical experience of the political system. Admittedly in the UK rather than the USA, but I do know how it works.
There needs to be a mechanism for doctors to prescribe Rapa or alternatively a change to enable people to purchase regulated medicines for their own use without having to import them.
It is not that difficult a change to the legal system. In fact I was for a while on a committee that could have enabled this.
In the US a substantial amount of Rxs are âoff label.â
I think the issue is more education of physicians who are open to the possibility that the risk / benefit of this therapy, based on what we know may favor prescribing this.
On my Rxs for this, most people are paying around $3 per mg here as is now generic sirolimus.
The main issue is lack of awareness, I donât think the Medicolegal or regulatory systems are the major inhibitors.
I think the rapidly expanding longevity community has to make some noise and find a way to get these technologies and drugs investigated.
âLongevityâ or geroscience is becoming a reality and major institutes are opening up. I live in Illinois, USA, and Northwestern Medical now has a Longevity Lab at the Potocsnak Longevity Institute. We are going to see the funding for these studies sooner rather than later. But when? This is where the greater community has to make some noise and drive these institutes to raise the monies to do the trials. There is money out there for things of this nature.
Northwestern Medicine
Feinberg School of Medicine
Potocsnak Longevity Institute,
I am interested in your institute first for extending my own longevity, and second to see if we can find one or more institutes willing to team up and enter the $101 Million Dollar XPRIZE Healthspan.
Geroscience trials of potential longevity compounds are of interest to the longevity community. The National Institute on Aging at the NIH, Interventions Testing Program (ITP) is a peer-reviewed program designed to identify agents that extend lifespan and healthspan in mice and the longevity community would like to test compounds on humans in one or more geroscience trials.
The following document is of interest as it names the ITPâs tested compounds and some of the research findings. If we had one trial the longevity community would support it would probably be the concurrent use of rapamycin and metformin to expand human longevity.
Would you like to comment on the following? The Potocsnak Longevity Institute has been mentioned.
I find it bizarre that people can kill themselves by overdosing paracetamol which can be bought OTC and yet trying to commit suicide with Rapa appears impossible but we have to have a prescription.
Rapa shouldnât be prescribed to all, it needs to be reclassified as an OTC medication.
Any chance you could influence that in the UK, John?
I can argue the case, but when I was on the Select Committee of the House of Commons for regulatory reform I was in the position where such a decision could be taken - by that committee. However, I am no longer an elected official so I can argue the case in the media, but I am not in a decisionmaking role.
It may be worth having a thread on this forum for people from the UK so we can put together a campaign.
Outside of longevity circles, thereâs not a large demand for Rapamycin. Even if it were OTC, weâd still buy generics from India because itâs 10% of the regular price. Everyone who wants to get Rapamycin can find a way to get it without a prescription.
I think that scientists are first awaiting the results from the TRIAD study. This will show longevity for dogs (Matt Kaberlein) and if that is positive, that will give more momentum for funding for a longer human trial. In the mean time i am interested in the âbite sized chunksâ of data coming out showing the various health benefits that rapamycin has for humans: Joan Mannick did two on rapamycinâs ability to boost the immune system in elderly, there is another on rapamycin benefitting insulin resistance and there is one in progress on rapamycinâs ability to delay ovarian aging.
I would love to hear of other bite-sized studies that people have found with regards to human health benefits.
The eternal question is one as to what an investor expects to get.
Public Funding bodies will spend funds in the public good. Investors may spend some cash where there is potentially a public good as a priority and in the background the possibility of an investment return. However, private investment at least in theory is about getting a profit. The difficulty is calculating what profit might be available. The is affected by whether the intervention works and what it then costs to get a return. (which is where the regulatory processes come in).