TAME metformin project: opinions are divided

The TAME metformin project raised the necessary $ 75 million.



It all started three years ago. In 2016, an article by Nir Barzilai et al. “Metformin as a Targeted Anti-Aging Tool” was published, in which they talked about the TAME project.



“ With the support of the NIA grant R24 (J. Kirkland, NB, S. Austad), we gathered gerontologists with experience in the field of aging biology and clinical geriatrics to discuss ways of targeting anti-aging in humans. These efforts led to the development of the study “Targeting Aging with Metformin” (TAME). This test has been reviewed under several funding mechanisms and has received planned funding from the American Federation for Aging Research. A supposed consequence of these efforts is the creation of a paradigm for assessing pharmacological approaches to slowing aging. Our proposed randomized controlled clinical trial, if successful, can significantly change the approach to aging and related diseases and affect the delivery of care and costs. If TAME demonstrates that metformin modulates aging and age-related diseases, in addition to its isolated effects on diabetes, this will pave the way for the development of next-generation drugs that directly target aging biology. Here we summarize the main reasons why metformin was chosen to start this study. ”

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And recently, project managers finally received the missing funds from an anonymous patron, raising a total of $ 75 million for the TAME project.

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Here are two comments about this momentous event. The first (critical) from the Fight Aging blog! And the second (acquittal) from Aubrey di Gray.



Fight Aging !:

¬- As you may have heard, or maybe not, the TAME study recently received the remaining $ 40 million thanks to charitable funding. In total, the test will cost $ 75 million, and, in my opinion, this is a waste of money. Aubrey di Gray from the SENS Research Foundation is much more polite in this topic in today's editorial, which is not surprising given our respective regulatory views.



Here I will focus on the fact that metformin is a weak remedy with little effect on life expectancy, unreliable data on animals, data on life expectancy in people from one study for diabetics, not healthy people, and side effects that are significant compared to the small size of the effect. The point of the TAME study is to convince the FDA to accept aging as a sign - or something close enough for people to work with. It never needed a test to exist in order to take place. An important work was the process of Nir Barzilai, its staff and supporters, such as people from Longevity Dividend, negotiating with FDA bureaucrats, amid growing patient activity regarding aging, which should be classified as a legitimate goal for therapy.



In addition, this work to fill the ditch dug by the FDA is not even needed. The same goal can be achieved by applying rejuvenation procedures through the FDA process for any relevant age signs. Then it was possible to enter into a constant struggle for misuse, which would be the overwhelming majority of all use for these procedures. This is exactly what will happen soon with the combination of dasatinib and quercetin, as the world realizes how great and reliable the benefits are for patients undergoing this type of first generation senolytic therapy. The way forward will be created for these very cheap, revolutionary methods of treatment, and then everyone else will be able to develop anti-aging therapy. Under this kind of pressure, the FDA will change because they should.



As the TAME study moves forward, we can hope that participating philanthropists may decide to do the same for senolytic therapy. What would be a much better choice if the required information was widely available back in 2015, when the TAME test began. However, the fact remains that in this area there is a much, much better use of the $ 75 million.

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Aubrey di Gray. “ TAME: Really Good Use of $ 75 Million ”



- The TAME test is an attempt to determine whether metformin, a well-known diabetes drug, has much wider benefits against late-life health problems - so wide that they can be unconditionally described as a solution to the aging problem. But wait, metformin is an old drug. I mean, a really old drug - it has been patented since time immemorial. There is no way to make money from it. So, how would we fund a clinical trial? Well, yes: the only way is charitable. This will happen only if there are people who are sufficiently convinced of the importance of such a test, and they will raise the necessary capital, even if it is not profitable.



But the logic is convincing in another way: precisely because metformin is such an old medicine, the test can immediately focus on effectiveness, in contrast to the need for rigorous safety tests, which would be the case with the new drug. And, of course, to a large extent, as soon as the idea of ​​such a test was formulated, almost half of the required $ 75 million was promised by longtime advocate of gerontology research, Paul Glenn, through American Federation for Aging Research. However, at that time, the pursuit of funds stopped for a couple of years. In particular, applications for the remaining money were rejected twice at the National Institute of Aging - but, as noted above, the remaining support materialized quite recently, thanks to an anonymous donor.



But the question remains: is this really the best use of $ 75 million in the anti-aging crusade? Well, this is several times more than the total amount that the SENS Research Foundation has collected in its entire history, so it won’t surprise you that I can’t look you in the eye and answer this question in the affirmative. But this, of course, is also not a waste of money: indeed, I feel that I can say that this is a pretty good use.



First, I think there is a reasonable chance that the study will be successful, albeit modest. There is no way that a short course of metformin will give people a decade of extra life, but all that is really needed here is a statistically significant improvement over control, and with such money, research can be effective enough to reach this threshold. Another justification for this test, perhaps even more. The point is that the study description includes the actual definition of aging as a clinical endpoint that has been more or less approved by the FDA, and which can thus be copied and pasted into any future anti-aging intervention test. This endpoint was the result of very difficult negotiations with the FDA, which were led by the priceless Nir Barzilai.

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