Friday, March 15, 2013

Alzheimer's Disease. FDA changes the rules?

From here:
 
The Food and Drug Administration plans to loosen the rules for approving new treatments for Alzheimer’s disease.
Drugs in clinical trial would qualify for approval if people at very early stages of the disease subtly improved their performance on memory or reasoning tests, even before they developed any obvious impairments. Companies would not have to show that the drugs improved daily, real-world functioning.       
For more than a decade, the only way to get Alzheimer’s drugs to market was with studies showing that they improved the ability of patients not only to think and remember, but also to function day to day at activities like feeding, dressing or bathing themselves.
The proposed policy could also be a boon for the pharmaceutical industry and researchers. They have often felt stymied by regulations that left them uncertain of how to get drugs tested and approved for marketing to people early in the course of Alzheimer’s, when the medications are most likely to be useful.
 
Wait a minute... What about "evidence based approach"? Well... Who cares! If there is a market for AD Big Pharma has to explore it! Who else would do it? And FDA just helps here in the way it can help...

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