November 28, 2007
Washington, DC: Dying prostate cancer patients waiting for the approval of Provenge, a new life-extending cancer vaccine, are being held hostage by an FDA infested with industry insiders with enormous financial interests in what has become a multibillion dollar cancer treatment racket for drug companies, cancer researchers, and treatment providers alike.
On May 8, 2007, FDA Commissioner Andrew von Eschenbach refused to approve
Provenge for men with end-stage prostrate cancer and instead, issued a Complete Response letter to Seattle-based Dendreon, the vaccine’s maker, requesting more data that may not be available until 2010.
Cancer patients and advocacy groups say intentionally delaying the approval of new therapies for terminally ill patients in order to protect profits in the research and treatment industry should be a criminal offense, and they are calling on Congress and the Security and Exchange Commission (SEC) to conduct a full investigation of the conflicts of interests involving the FDA officials responsible for the non-approval of Provenge.
As for the data requested by the FDA, an accurate assessment of the full effects of Provenge on survival can not be assessed easily because many of the participants in the clinical trials are still alive many years after they received the vaccine.
In a perverse twist of fate, because patients are living longer with a vaccine that works, it will take longer to provide the FDA with the data it requested.
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