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Funding for a study of anti-aging properties of the diabetes drug Metformin?
Advancing age brings with it a host of health risks, and while modern medicine works to treat many of the conditions associated with aging, no therapy is yet approved to treat aging as an underlying condition.
Slow aging, some researchers say, and you can extend a person's "healthspan," or years of relative health. Delaying aging could also delay the onset of cardiovascular disease, diabetes, cancer, cognitive decline, and other conditions. To spur development of anti-aging therapeutics, however, researchers must first convince the US Food and Drug Administration (FDA) to approve aging as a disease or pharmaceutical target, also called an "indication."
A trial balloon in this effort is a study called Targeting Aging with Metformin, or "TAME." The study, led by Nir Barzilai of the Albert Einstein College of Medicine, aims to enroll 3,000 people in a double-blind controlled experiment to see if the diabetes drug metformin can extend the human healthspan and lifespan. Metformin, considered the first line of defense against Type 2 diabetes, lowers blood sugar and increases insulin sensitivity. At around 35 cents per pill, it's relatively inexpensive.
Studies have found an intriguing side effect of metformin, however. The drug increased the lifespan of worms and some mice. A UK study of patient data suggested a possible lowered risk of cardiovascular disease in metformin-treated diabetes patients. Another study of patient data suggests that diabetes patients in their 70s, treated with metformin, experienced around 15% less mortality than their diabetic peers treated with other methods. Scientists think the drug may reduce inflammation and slow the process of cell senescence, a component of aging.
Although TAME shows promise, and the protocol was approved by the FDA in June 2016, the program is unfunded. Costs are expected to reach $50-65 million. Without funding, TAME cannot proceed.
Funding could come from private or public sources. Pharmaceutical companies have the deep pockets that TAME needs, but may be reluctant to invest in the study since a previous anti-aging effort cost more than $700 million and has been fruitless so far in clinical trials. And, with metformin already established as a drug, pharmaceutical companies cannot exclusively profit from it as they would with a newly developed therapeutic.
Another possible funding source is a line in the US Department of Defense's budget called the "Peer Reviewed Medical Research Program," (PRMRP) which distributes funding for basic medical research. For 2016, Congress appropriated $278 million for the program. Visitors to TAME's website are encouraged to write to their congressional representative to encourage further appropriations of $13 million per year for the PRMRP, funds that could support the initial years of TAME.
According to the House Committee on the Budget, any action on the FY 2017 budget will be in place by June 30, 2017. PRMRP proposals are typically submitted in the spring, in advance of the fiscal year beginning on October 1.
Will TAME secure enough funding, public or private, to proceed by October 1, 2017?
To resolve positively, a credible media story or TAME-affiliated press release must report that the program has received at least $13 million in funding, enough to commence the first year of the study, regardless of the funding source, on or before October 1, 2017.
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