The FDA did introduce its Critical Path initiative in 2004. But, even these expedited processes have become bogged down. The FDA has responded to the political winds and become cautious after the negative publicity it received from the withdrawals of drugs like Rezulin and Vioxx. The best and most recent delay in the prostate cancer world has been Provenge.
Once a drug passes Phase I clinical trials — which test for high toxicity — and Phase II which defines dosing- why not make it available for general distribution through the NCCN, which has superior access to specialized medical expertise than the FDA. The blunt fact is that no matter how able FDA scientists and physicians are, none of them have the years of experience dealing with particular tumors and particular drugs that specialist, scientists and physicians can bring to this project.
Joel T Nowak MA, MSW
My father died 10 days ago from prostate cancer.i believe that he would most likely be alive today if provenge and some of the other promising drugs were available.My father tried leukine and sutent which did nothing but allow his cancer to grow and to allow his psa to go from 75 to 1000 in a matter of 4 months. Although there may be more options than in years past, truthfully, the options, the good serious options, are very limited.When peoples lives are on the line patients have NOTHING TO LOSE and only to gain. Why can’t these drugs be made available?
Blossom,
My deepest sympathy to you and your family on the loss of your father. I hope that you and your family members will eventually be able to celebrate his life and his accomplishments.
Joel