According to an article written by Reuters some doctors have raised doubts about the efficacy of Provenge, known scientifically as sipuleucel-T. Prostate cancer vaccine Provenge has long incited passions unlike any other cancer therapy and the story seems to continue even to today.
The current issue has been raised by Marie Huber, a trained scientist and former hedge-fund analyst. Last year she analyzed what she believes are deadly flaws in the studies that led to the approval of Provenge by the FDA. She concluded that Provenge which showed that it extended survival was flawed. She claimed that older men in the study who did not receive Provenge, or received the placebo, died months sooner than similar patients in other studies.
She expressed concern is that the “placebo” they received was actually harmful and made Provenge look better by comparison or created a statistically false survival benefit.
Huber published her concerns in a February paper in the Journal of the National Cancer Institute.
Dendreon, the company responsible for the creation of Provenge, insists Huber’s analysis is flawed. “I’m looking forward to getting this to patients around the world,” said President and Chief Executive John Johnson.
In the pivotal trial called IMPACT, published in July 2010 Provenge extended median survival