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  • June 24: FDA To Hear Researchers Pitch For Human Clinical Drug Study To Allay Aging

    June 22, 2015: by Bill Sardi

    Ten years ago the Rand Corporation think-tank penciled in anti-aging pills into future Medicare budgets.  That prognostication has been forgotten.  Covert opposition to anti-aging pills, in particular resveratrol, has been the order of the day for the past decade.  Various spin doctors have misled the public on this miraculous red wine molecule over the past decade.  [ResveratrolNews.com Dec 29, 2014; LewRockwell.com Nov 13, 2006]

    Promising studies built up hopes of such a pill but those hopes were then dashed by specious studies that over-dosed lab animals thus negating resveratrol’s beneficial effects or misinterpreted data, such as the more recent wine study conducted in Italy.  That study didn’t even use resveratrol pills but mistakenly concluded resveratrol didn’t reduce mortality rates among adults living in the Tuscany region of Italy but failed to note heavy tobacco use negated any life-prolonging benefits of wine and overlooked that wine nearly halved the rate of mental decline. [ResveratrolNews.com May 12, 2014]

    Another tactic has been to ignore resveratrol altogether.  Despite resveratrol being panned as the reason for the French paradox, that the high calorie/high cholesterol eating French have lower rates of mortality from coronary artery disease due to their consumption of red wine, there has not been a single human clinical trial of resveratrol for heart disease or cancer, two of its most promising applications.  [ResveratrolNews.com Dec 29, 2014]

    Enter Dr. Nir Barzilai MD, director of the Institute for Aging Research at the Albert Einstein College of Medicine and scientific co-director of the American Federation for Aging Research.  Dr. Barzilai and colleagues will present a clinical trial called Targeting Aging With Metformin (TAME study) to an FDA panel.  [HealthspanCampaign.org]  Metformin is an inexpensive anti-diabetic drug that has been compared against resveratrol as an anti-aging agent.  [Biofactors Sept-Oct 2010]

    While longevity is one aspect of the proposed study, another important aspect is to determine if a drug such as metformin can promote healthspan as well as prolong lifespan.   The TAME study will enroll 1000 elderly subjects in a study that will take 5-7 years to complete.   Already another study has posited the effect of metformin for senior adults.  Patients who took metformin outlived non-diabetics with a 15% greater survival rate.  [Wall Street Journal March 16, 2015]

    Another research team, this one at UCLA, now claims healthy longevity is within reach and all that need be done is to elevate an enzyme called AMPK, a cellular energy-sensing protein. [UCLA Newsroom Sept 8, 2014]  Of note, a mild dose of resveratrol elevates AMPK 50-200 better than metformin. [Diabetes Aug 2006]

    Will the FDA, for the first time, give the go-ahead to test a drug that does not prevent, treat or cure a disease?

    Metformin is fraught with problems – it depletes vitamin B12 [Diabetes Care Feb 2012] and has been associated with declining mental function. [Diabetes Care Oct 2013]  Metformin also interferes with vitamin B1 (thiamin). [Archives Internal Medicine April 28, 2003; Proceedings National Academy Science July 8, 2014]

    Nonetheless, metformin (Glucophage) has a good chance of working.  Few if any observers of the drugs and circuses that have gone on in past few decades ever expect to see a nutraceutical like resveratrol be put to the test, even though it is safer and biologically more effective than metformin.  Hopefully the $50 million TAME study won’t be a flop.  FDA investigators say they are open to the idea. [Nature June 17, 2015]

    Maybe if metformin produces a modest health benefit and prolongs human life modestly, the pressure for the FDA to approve and therefore Medicare pay for an anti-aging pill will be appeased.  The public will still be taking drugs, not nutraceuticals.  Again, resveratrol is destined to get side-tracked in the process.  -©2015 Bill Sardi, ResveratrolNews.com

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