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To FDA Aging Is Not a Disease, So FDA Will Not Approve Drugs that Extend Life



(p. D1) Some of the top researchers on aging in the country are trying to get an unusual clinical trial up and running.


. . .


The trial aims to test the drug metformin, a common medication often used to treat Type 2 diabetes, and see if it can delay or prevent other chronic diseases. (The project is being called Targeting/Taming Aging With Metformin, or TAME.) Metformin isn't necessarily more promising than other drugs that have shown signs of extending life and reducing age-related chronic diseases. But metformin has been widely and safely used for more than 60 years, has very few side effects and is inexpensive.

The scientists say that if TAME is a well-designed, large-scale study, the Food and Drug Administration might be persuaded to consider aging as an indication, or preventable condition, a move that could spur drug makers to target factors that contribute to aging.


. . .


(p. D4) Fighting each major disease of old age separately isn't winnable, said S. Jay Olshansky, another TAME project planner and a professor at the school of public health at the University of Illinois at Chicago. "We lower the risk of heart disease, somebody lives long enough to get cancer. If we reduce the risk of cancer, somebody lives long enough to get Alzheimer's disease."

"We are suggesting that the time has arrived to attack them all by going after the biological process of aging," Dr. Olshansky said.

Sandy Walsh, an FDA spokeswoman, said the agency's perspective has long been that "aging" isn't a disease. "We clearly have approved drugs that treat consequences of aging," she said. Although the FDA currently is inclined to treat diseases prevalent in older people as separate medical conditions, "if someone in the drug-development industry found something that treated all of these, we might revisit our thinking."



For the full story, see:

SUMATHI REDDY. "To Grow Old Without Disease." The Wall Street Journal (Tues., March 17, 2015): D1 & D4.

(Note: ellipses added.)

(Note: the online version of the story has the date March 16, 2015, and has the title "Scientists' New Goal: Growing Old Without Disease.")






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