I woke this morning feeling very angry and much stressed. One of the principles in cancer management is to reduce, ideally remove stress from ones life. Now the FDA is adding stress, major stress to my life. When I heard about the FDA action I was disappointed, but not angry. As the evening went on [...]
Today I received the following e-mail and press release from Dendreon's Senior Director for Government Affairs, Chris Lockett. At this time the FDA did not grant Dendreon a license to market its immunologic therapy Provenge! The FDA has requested additional information from Dendreon pertaining to data which would support its efficacy as well as information [...]
The following was submitted to the FDA in support of the development of additional treatments for men with advanced prostate cancer, including Provenge. The advocates of "Raise a Voice", a grass roots initiative for advanced prostate cancer, would like to express our appreciation for the opportunity to present comments at the Cellular, Tissue and [...]
The controversy that has been haunting the FDA approval of Provenge (sipuleucel-T) still continues with major fireworks on all sides. I have written a number of pieces about Provenge in this blog, so if you are not familiar with this potential new treatment you might want to go back and read them. Pay particular attention [...]
PSA Rising has just posted transcripts of the patient advocates testimony which was delivered to the FDA's Advisory Committee at the recent Provenge hearing. I have written extensively about the hearing and the role of patient advocates at this hearing in an earlier post. For anyone interested, six of the patient advocates testimony, including my [...]