In today’s Wall Street Journal there is a fantastic opinion piece written by Dr. Mark Thornton, Black Wednesday at the FDA. Dr. Thornton points out that not only did the FDA not approve Provenge last Wednesday, but also it failed to approve Junovan, a immunological drug designed to treat young children with a rare bone [...]
The Wall Street Journal's health blog has exploded with comments about the recent article about the FDA and Provenge. Their piece along with the comments are a must read. You can see the blog at: The Wall Street Journal Health Blog Please don't forget to www.malecare.com and sign our letter to the FDA. Our letter [...]
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 [...]
Clarifying the Issues Surrounding Dendreon's Provenge Posted on Apr 16th, 2007 with stocks: DNDN Wall Diver submits: Rebuttal to article, "Dendreon's Provenge Apart by ODAC Member": On April 13, 2007, in Volume 33, No. 14 of The Cancer Letter, a letter was published which the Editor, Paul Goldberg, attributed to Howard Scher, MD, of the [...]
Dr. Howard Scher, M.D. was one of the four members of the Provenge advisory committee who voted against recommending that the FDA approve Provenge. Dr. Scher is a respected clinician (practicing at Sloane Kettering Hospital) and researcher. I do believe that his letter contributes to the discussion about Povenge and so I have chosen to [...]
Last Thursday, March 29, 2007, I had the opportunity to participate as a patient advocate in the FDA's Tissue, and Gene Therapies Advisory Committee. The purpose of the committee meeting was to evaluate the application of Dendreon Corp for approval of their new drug, Sipuleucel-T (Provenge). I want to clarify the facts and dispel some [...]
