The Global Healthspan Policy Institute Wants Your Support in Lobbying for TAME Metformin Trial Funding

The Global Healthspan Policy Institute (GHPI) is a recently launched group whose principals are focused on much the same goals as the researchers of the Longevity Dividend initiative, which is to say pulling a lot more public funding into aging research aimed at extending healthy human life spans. The chosen methodology is the traditional one of lobbying and political action, aimed at politicians and bureaucrats who influence budgets relevant to the National Institutes of Health, the National Insitute on Aging in particular, and other public sources of medical research funding.

The first public initiative for the GHPI is to petition and lobby for political support and public funding for the proposed TAME human trial of metformin as a drug to treat aging. The expectation that this will produce meaningful results in terms of extended health seems low to me, unfortunately: the animal study evidence for metformin to influence aging is scattered, contradictory, and terrible. This drug is, however, very safe, already approved, and widely used for decades. Arguably the real purpose of this exercise is to push the FDA into accepting a trial for a treatment aimed explicitly at intervention in aging rather than the treatment of any specific disease, using a vehicle - metformin - that regulators can't possibly object to on other grounds. Then the door stands open to anyone else with a potential therapy to treat the causes of aging. The FDA is otherwise a roadblock for all who wish to work within the US regulatory system, as its bureaucrats have up until this point not recognized aging as a medical condition and thus blocked any possible treatments for aging from entering the approval process. This in turn echoes back down the chain of research and development to make raising funding very challenging.

Ask Congress to Fund the First FDA-Approved Drug Trial to Prevent Cancer and Other Diseases of Aging

Aging brings illness. All of our major diseases get worse as we age, including heart disease, cancer, arthritis, dementia, cataract, osteoporosis, diabetes, hypertension, and Alzheimer's disease. Now for the first time in history, the US Food and Drug Administration has approved human testing of a drug to slow human aging that would decrease the risk for all of these illnesses, dramatically lowering healthcare costs and boosting quality of life for the elderly. Named "one of the most innovative projects of the year" by the Washington Post and the subject of the hit Ron Howard documentary "The Age of Aging", the TAME/Metformin study would take place in research centers nationwide.

Unfortunately, this study will not be funded by drug companies. Metformin has a long history treating diabetes, so it is known to be safe, but its also past the early phase where a drug company will invest in a drug because it can own it and profit by it. So the only way for this landmark drug trial to move forward is to be funded by Congress, much like they have funded thousands of other studies. The Global Healthspan Policy Institute is leading this charge. We are a non-profit think tank and policy institute that does not represent any government agency, corporation, or medical center. We have many allies in Congress who love the project, but we need your help with specific members of Congress whose position on appropriations committees can make or break this movement.

Petition: Tell Congress to Fund Critical Healthspan Research

Right now, the federal government spends billions each year in medical research seeking to cure one disease at a time - while virtually ignoring the underlying processes that eventually lead to a whole host of fatal diseases. It is estimated that 75 percent of the $1.9 trillion spent on all health care in the United States stems from preventable chronic health conditions - but only 1 percent is allocated to protecting health and preventing illness.

Every year Congress sets the Department of Defense's budget, which contains a "Peer Reviewed Medical Research Program" just for research like the TAME/Metformin drug trial. Join us in asking Congress to allocate funds. To get started they need $13 million per year for the first two years for the TAME/Metformin study that will span 6 years for a total cost of $64 million. Funding will be given to 14 university locations around the country - including possibly in your state - that will study a total of 3,000 people.

Let's plant the seeds for a future where we can all have more healthy, productive years of life - where major diseases can be stopped before they ever begin, and no one has to shoulder the burden of rising healthcare costs. Tell your representative today!

I'm sure you all know my opinions on engaging with a broken system of regulation and on metformin by now, so I won't do more than summarize. I think that the damage done to the pace of progress by the FDA is best fought by avoiding that agency so as to make it irrelevant, not by legitimizing it through engagement, and the best way to do this is for treatments to be deployed to clinics outside the US and accessed via medical tourism, just as happened for stem cell medicine. More bluntly, I see work on metformin in connection with aging as a waste of effort. It is a comparatively bad choice, as compared to, say, rapamycin analogs, within what is itself a comparatively bad class of initiatives to treat aging, mining existing drugs to find those capable of marginally slowing the aging process. This approach is both expensive and capable of producing at best poor results that are of little use to people already old and damaged. It boggles the mind that so much time and effort is spent on this type of research and development in an age in which senescent cell clearance and other forms of damage repair for living beings, capable in principle of rejuvenation of the old, and already producing much more robust results in animal studies, are in or nearing clinical development.

I understand that I'm in a minority in holding these views, that the majority of the community would rather fight for change within the present system, and that there are people geared up and ready to go with the TAME organizational and lobbying efforts. But if people absolutely must have this fight with the FDA, to expend significant resources to try to change the system from within, I'd rather it was happening two or three years from now for the first trials of senescent cell clearance therapies - a rejuvenation treatment with a high expectation of producing meaningful and reliable benefits in humans, rather than something that I expect to produce results that lie somewhere between nothing and a tiny statistical benefit.

I encourage you all to make up your own minds of course, and you should certainly take a look at what the Global Healthspan Policy Institute is up to, and keep an eye on their progress in the years ahead.

Comments

Mmm if the trial is already approved by the FDA, doesn't that mean that the FDA has recognized aging as a medical condition? Or, putting it other way, doesn't it mean that a senescent cells clearance therapy would have no problems to be approved?

Posted by: Antonio at February 24th, 2016 7:01 PM

@Antonio: I suspect that it is still a big grey morass, and that it is still very unclear as to what would happen if another group made a trial proposition. We shall see in over the next few years, no doubt.

Posted by: Reason at February 24th, 2016 7:22 PM

During the XXth Century lifespan has doubled around the world and longevity is around us all the time. At first glance longevity seems as a fantastic achievement but a more detailed analysis indicates that most of us will live at least 10 years in poor health before dying. So we must slow aging! If Metformin delivers its promises and slows the aging process we will live our last years with the dignity we all deserve!

Posted by: Patricio at May 24th, 2016 12:26 PM

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