MR. WALDENFELS: I am Jim Waldenfels, a board member of the Virginia Prostate Cancer Coalition, but speaking on my own behalf. I have no financial conflicts of interest or sponsor ties. Thank you for incorporating a public comment period into your review process. This is why I have a very personal interest in Provenge.
My first PSA test result, when I was age 56, was 113 and within days of biopsy indicated an aggressive Gleason 7 cancer with all cores positive, most 100 percent. Within a month, respected urologists from Johns Hopkins and the City of Hope had both given me a prognosis of five years, three good years and two declining years. That was December and January of 1999 and 2000. Today, seven years later, I am fit and vigorous as I enter the fourth off-therapy - fourth month
off therapy under my second off-therapy cycle of intermittent triple blockade, achieved without surgery or radiation. At the end of both off-therapy cycles I achieved a PSA low point of less than 0.01. During the first off-therapy period, virtually all my side effects disappeared, and I expect the same for this period. However, despite my highly successful treatment, my cancer is still likely to become resistant to hormone blockade at some point. My case illustrates that prostate cancer is developing so rapidly that the - technology, the knowledge about it is developing so rapidly that even good doctors cannot keep up with all developments, and key new knowledge emerges in the middle of clinical trials.
Before retiring, I served as a Navy contract specialist and contracting officer for the research and development test and evaluation of weapons systems. DoD faced a similar problem to that facing the prognostic factor prostate cancer community. The nature of the threats and technologies was changing so rapidly in the `90s that our standard procurement and development methods were not keeping up, and we were risking obsolescence at first delivery of equipment. In order to meet needs, we had to radically change our way of doing business, and we did. Similarly here, cancer technology and particularly the knowledge of the effect of prostate cancer immune responses to drugs is changing more rapidly than can be accommodate in trial designs. That puts a high premium on judgment in capitalizing on trial results.
The 55,000 patients now hormone-refractory and asymptomatic and those of us waiting in the wings are counting on this committee to give us Provenge as a badly needed option. Its effectiveness has been proven. Remember those patients who beat
the heck out of the median like Mr. Garcia. We haven't heard much about that in this meeting, but remember that. We can look forward to even better targeting of this drug. It has an excellent side effect profile. Please help us.
(Applause)
DR. MULÃ: Thank you, Mr. Waldenfels.
