The FDA approval for Provenge was based on clinical data that showed a 4 month increase in survival showing a 25.8 month survival with Provenge compared to 21.6 months for the placebo injection. However the placebo injection has come under scrutiny and probably reduces survival which shows a false life extension.
This anomoly is highlighted by results from the latest Zytiga trial which showed that patients who were treated with the placebo lived for 27.2 months which is actually longer than people treated with Provenge. So a true placebo shows a survival of 27.2 months, Provenge shows a survival of 25.8 months, and the Provenge Placebo group had a survival of 21.6 months. These figures clearly show that the Provenge Placebo is toxic and actually causes decreased survival. In view of this decreased survival using a Provenge Placebo vaccine raises issues about the ethics of giving such a treatment to terminally ill men with prostate cancer.
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