The FDA's decision to delay approving Provenge until Dendreon can provide additional efficacy data has triggered intense anger among patients desperate to get the vaccine, which is designed to allow patients to live longer with advanced prostate cancer by stimulating their immune systems. The FDA's delay was at least partly attributed to the opinions of two top oncologists who questioned the drug's effectiveness. Now the experts have been exposed to threats, accusations of conflicts and the full-throated furor of cancer advocacy groups.
One other reason for all the buzz this week about Provenge: A new study is raising questions about the way cancer vaccine trials are designed. Cancer vaccines and therapeutics have been tested the same way as trials sought data related to tumor shrinkage. But vaccines can take longer to demonstrate a benefit and the study in Clinical Cancer Research suggests that the vaccines will allow patients to live longer and suffer less toxicity.