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Forbes.com

 

The FDA and Methuselah

April 12, 2010

By Peter W. Huber

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Cellular intervention to slow aging is a science in its infancy. Will regulators keep it there forever?

Death panels are nothing new--they’ve been convening in Washington since 1962. The panels are composed of doctors and scientists. They report to the Food & Drug Administration, not the federal agencies that pay so many of our medical bills. Their inadvertent and unstated mission is to make sure that medical science as certified on the banks of the Potomac continues to view aging as an untreatable part of normal health.

As Greg Critser discusses in his recent book, Eternity Soup, there are three general schools of thought on how we can slow--or perhaps even ultimately halt--the aging process. At the front end we can attempt to slow or halt the molecular processes that gradually wear out and damage genes, cells, tissues and organs. At the back end we can try to treat the large-scale clinical symptoms that appear when molecular damage morphs into large-scale clinical symptoms--clogged arteries, arthritis, tumors and so on. In the middle we can try “pure engineering.”

Aubrey de Grey, a Cambridge University cell biologist and the most prominent champion of engineering, uses the analogy of how some people manage to cruise today’s roads in perfectly preserved Model Ts. The car wasn’t designed to run for a century. Nothing stopped normal wear and tear every time it was driven. Constant repair and maintenance are what did the trick. De Grey is focusing on seven possible areas of “cellular intervention” to slow aging. But the science is clearly in its infancy.

It will stay there forever unless Washington fundamentally changes the way that it licenses drugs.

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 De Grey suggests they might, by repairing damage at the cellular level before it morphs into clinical problems.

Under rules set in place during the Reagan Administration, initially to facilitate the licensing of hiv drugs, the FDA will sometimes license drugs that change the low-level chemistry of disease--viral loads, cholesterol levels or rogue proteins--but only when the changes in these biomarkers “reasonably suggest” clinical benefits in the future.

Projecting from microscopic changes today to clinical benefits tomorrow is quite easy when streptomycin expels the cholera bacterium. But many viral diseases and cancers are beaten only by cocktails. Almost all cocktail therapies get approved by the FDA only after the ingredients are licensed separately. If the feds licensed aircraft this way, each new rudder, flap and aileron would require a separate license, and then later on, after each separate control surface had been flying solo for a while, they might consider licensing the whole Dreamliner.

A process as multifaceted as aging will almost certainly require more complex cocktails than those used to beat a single virus or cancer, and each one will have to be adjusted to fit the patient’s unique biochemistry. Any one used on its own might well end up shortening life rather than prolonging it. An 80-year-old heart may not be able to handle the muscles or libido that is 60 years younger.

Medicine’s war against aging won’t get serious until the FDA begins licensing drugs the way that it licenses devices like scalpels and sutures--as tools used for regular, customized maintenance, building and repair. Until then the FDA will remain Treasury’s best friend. It’s the only agency that can make sure that few of us will be collecting Medicare benefits on our hundredth birthday.

Original Source: http://www.forbes.com/forbes/2010/0412/ideas-death-panels-fda-medicine-science-aging-insights.html

 

 
 
 

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