eric.whitman

Dendreon's Provenge: Looking Past The Noise

1. Active cellular immunotherapies have been around for decades--and have never been shown to work in humans. What do you think a "tumor vaccine" is (see Antigenics, Canvaxin)?
2. The statistics are very clearcut that Provenge does not necessarily provide ANY survival benefit. There are two parallel trials. One shows that there "may be" a 4 month benefit. The second trial, identical to the first, showed no survival benefit at all. The third trial, with 500 patients, won't have results for several years. There MAY be an interim report in mid-2008.
3.The 13-4 vote was not about efficacy. See Dr. Scher's letter at psa-rising.com/blog/in.... The question was changed mid-meeting by the Committee Chair from "establish the efficacy" to showing "substantial evidence."

FINALLY, the FDA has made a reasonable data-driven decision in the face of massive ill-informed emotional support for a drug that may or may not work. We do clinical trials to get answers, not to go back afterwards and look for better questions.