As Peter pointed out (try saying that ten times fast) the FDA leadership is poised to move the agency into the 21st century and with it the ability of medicine to be predictive and preventive. More to the point, it is imperative that, we are able to accelerate and reduce the cost of bringing new cures to market. There is no reason why the fight against Alzheimer’s Disease should not get the same Part E approach as cancer and HIV and no reason why the Critical path can’t be used to make it happen at the reviewer level. And there is no reason why the FDA cannot help pave the way for faster, smarter scale up of vaccine facilities for products against neglected global diseses.
IT will need help — a consortium with money will do. But the enemies of medical progress are all around. They put their political careers and hatred for drug companies first and foremost. They blame everything, include the tragic physicial attacks on their staffers, on drug companies and those that support them. As the Tysabri case showed, they created an environment where a highly effective medicine for a debilitating disease was treated as more toxic than aspirin.. This was the result not of scientific concern but of political pressure. People suffered and their condtions worsened because of the grandstanding and moralizing of some inthe media and the halls of Congress. And they will perpetuate that suffering if they get their way.
We won’t let that happen..