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The FDA Must Go

Posted: November 28, 2010 at 12:21 am

From the Huffington Post: "There is no question that social equity issues such as poverty and access to medical treatment affect life expectancy. The same is true with our life style choices (e.g., eating, exercise). Yet the precise benefit often is elusive as is the case for alcohol where epidemiological studies find surprisingly contradictory results. So, what happens when we throw [the] FDA into the brew? We have a system of FDA approval that requires a pharmaceutical company show three things: (1) a mechanism of action (i.e., identify why a drug works), (2) safety and (3) efficacy in managing a measurable biologic end point associated with a disease. This last condition is a problem. Look at the conundrum: You're a researcher and you walk into FDA one day and say: 'I have in this bottle an elixir that if taken every day of your life will add on average 4 years to how long you can expect to live.' FDA says: 'What disease will it cure?' The researcher says: 'It won't cure disease, it will postpone or mitigate the lethality of some diseases, but as you get older you will get other diseases.' FDA then hopefully says: 'We get it. While we do not now nor have we ever thought about age as a disease metric, we accept the concept. All we need to do is test your drug on a sufficiently large population and for a long enough period of time to prove to us it works.' That is the problem." For so long as the FDA and its more similar foreign counterparts exist, progress in turning science into applied longevity-enhancing therapies will be greatly slowed.

Link: http://www.huffingtonpost.com/gary-liberson/does-fda-need-to-rethink_b_787383.html

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