Up Yours

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PROSTATE CANCER & PROVENGE _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________ ________

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BACKGROUND INTRODUCTION • According to the 2003 CDC data, 30,000 men/year (82 men/day!) will die from prostate cancer. The average life expectancy for a terminal prostate cancer victim is about 19 months. The only FDA approved treatment for these patients is a chemotherapeutic drug with severe side effects, which only extends life expectancy some 10 weeks. The present chemotherapy for these patients is so toxic and marginally effective, most terminal prostate cancer patients choose not to take any chemotherapy at all.

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BACKGROUND INTRODUCTION  In the early stages, PC often does not cause symptoms  By the time symptoms occur, the disease may have spread beyond the prostate  The symptoms that may be present are frequent urination, especially at night, inability to urinate, trouble starting or holding back urination, a weak or interrupted flow of urine, painful or burning urination, blood in the urine or semen, painful ejaculation, frequent pain in the lower back, hips, or upper thighs

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BACKGROUND INTRODUCTION  EARLY DETECTION IS THE BEST PROTECTION  BE SURE TO SEE YOUR DOCTOR REGULARLY FOR SCREENING AND YEARLY CHECK-UP

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ABOUT PROVENGE  Active Immunotherapy (trains the patients own body to fight the cancer cells) Drug For Androgen Independent Prostate Cancer  Mild side effects similar to a flu shot  34% of treated patients alive at 3 years versus 11% in control group

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ABOUT PROVENGE (Cont)

 75% of control group patients crossed over to Provenge on progression

 Provenge group lived an average of 4.5 months longer than control group  For PC specific survival the Provenge group lived an average of 11.7 months longer

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THE PROVENGE STORY BEGINS….  On March 29th, the FDA Advisory Panel voted 17-0 that Provenge is safe  They then voted 13-4 that Provenge is effective  On May 9th the FDA issued a Complete Response letter delaying Provenge for up to four years

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THE PROVENGE STORY BEGINS….  Provengenow.org was set up to support Provenge and expedite approval  Prostate Cancer Survivors and Advocacy Groups rallied in D.C. on J une 4, 2007 and Chicago on J une 2, 2007 to express their dissatisfaction with the FDA’s decision to delay Provenge

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WHAT WENT WRONG?  Three of the panel members voting against Provenge had Conflict of Interest Waivers  Two physicians on the panel had major COI’s that they did not reveal  Provenge versus Chemotherapy – You Decide

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A CALL TO ACTION!! THINGS YOU CAN DO…  Contact your senators and representatives to demand a congressional investigation of the FDA  Voice your opinion by calling and writing your local media outlets, family members, friends, neighbors and anyone who will listen  Support your local advocacy groups  Support and/or attend future rallies

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FOR MORE DETAILED INFORMATION GO TO…  www.provengenow.org  www.caretolive.com  www.provenge.blogspot.com

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REFERENCES  http://www.cancer.gov/cancertopics/factsheet/Detection/earlyprostate  http://www.cdc.gov/cancer/prostate/basic_info/

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