The Roadblock That is the FDA

A Forbes columnist points out the insanity of the FDA regulations that block any consideration of treating aging: "For the most part, the FDA still operates under the medical mind-set that prevailed when the federal drug law was amended in 1962. The go/no-go regulatory calls are decided by clinical trials. The key metrics are clinical, like the survival time for a cancer patient. A clear reduction in mortality from a serious disease gets the drug licensed on the double. So far, so good - this panel sounds diligently antideath. But it's interested only in brinkmanship, at the back end. The 'aging' drugs that the FDA deals with reasonably well are the ones that beat back a single specific disease long after the microscopic seeds of the problem have blossomed into big symptoms. Aging is an incremental, whole-body problem. All cells, tissues and organs age - and in different ways, at different rates, in different people. As defined by their late-stage clinical symptoms, the diseases of old age are legion. At the FDA they will have to be beaten one at a time or not at all. Which means that nobody is ever going to get 'antiaging' drugs through the FDA as it currently operates. Certainly not drugs that operate the way [biomedical gerontologist Aubrey de Grey] suggests they might, by repairing damage at the cellular level before it morphs into clinical problems."


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