Traditionally, the FDA makes its regulatory decisions based solely on demonstrated safety and provable increases in meaningful survival data. The FDA asks, Will a new treatment that is being considered for approval be able to extend our life longer than the current standard of care? They also ask if it will extend our life is it safe for us to take?
In cancers like prostate cancer these survival statistics take time to mature. In a way this is great news as it means that we tend to live for a good period of time with our cancer. On the flip side this also means that new drugs in clinical trials take excessive time to prove that they can extend our survival time.
Does this FDA policy work against us by allowing good drugs to linger longer than they should in the approval process, thus denying the treatment to men in immediate need? This question is especially relevant in the slower progressing cancers like prostate cancer. Does this process mean we have less approved drugs and does this process mean that our drugs, when approved, are more expensive because we are forcing longer and more expensive clinical trials?
Consumer groups and