March 26, 2007

 

Cellular, Tissue and Gene Advisory Committee

Federal Drug Administration

 

Attention:

Ms. Gail Dapolito

Executive Secretary

 

Dear Committee Members,

 

This letter is in reference to the March 29th hearing on approval for the active cellular immunotherapy (ACI) treatment Provenge.

 

I am a seven year prostate cancer survivor who witnessed the deaths of my father and both grandfathers from this sinister prostate cancer disease. I have seen the devastation of this disease up close and personal for much of my life, and it is not a pretty picture. As an African American I am in the midst of a prostate cancer epidemic within all our communities and we need help – now. With a death rate 140% higher than for other men, coupled with a comparable level of suffering and quality of life loss, our need for new and innovative treatments is desperate and unparalleled relative to any other type of cancer in terms of the death rate disparity. 

 

I have written two books and founded PHEN in efforts to address the African American prostate cancer disparity. PHEN is on a continuing quest to identify treatments and other strategies to help eliminate this disparity. PHEN has interfaced with three biotech companies over a three year period to better understand the potential benefits of ACI as a treatment. A treatment that could help reduce the deaths and suffering caused by the African American prostate cancer epidemic conditions. We invited the CEO’s of two of these companies, including Dendreon, to present at our annual “African American Prostate Cancer Disparity Summit” on Capitol Hill. Through these efforts we gained a good insight into the clinical trial results for Provenge. After closely studying these results, our position is that Provenge should be approved because of the treatment advantages it provides when compared to chemotherapy treatments which are now the only choices for men with late stage prostate cancer.

 

We understand, appreciate and respect the challenges before the committee members to analyze all the data and information before you and make the right decision. As a prostate cancer survivor, and on behalf of other survivors, I cannot stress strong enough the immediate need for relief from a disease that during its latter stages is relentless in taking away our quality of life, and then our lives. All prostate cancer survivors live in fear of a cancer recurrence and with a hope that should that happen our lives, and the quality of our lives, can be saved.  This is our real world, in what I refer to as battling the killer within.

 

Relative to current treatments available for hormone refractory metastatic disease, data shows that   treatments with Provenge allow patients to maintain a much higher quality of life. If Provenge did not exhibit a survival benefit at all, the quality of life benefit alone would represent a tremendous help and improvement for survivors. However, Provenge clinical trials show a statistically significant survival benefit which represents increased hope.

 

We ask that the committee understand, appreciate and respect the real life needs of prostate cancer survivors, and approve Provenge to make it immediately available to help reduce the suffering currently experienced by men with hormone refractory metastatic disease. Would it be a right or moral decision to deny any prostate cancer patient faced with the possible end of his life the relief that Provenge has proven to provide now? What is the benefit in waiting?

 

During its deliberations, we also ask that the committee strongly consider the urgent needs of a segment of the U.S. population that is suffering from prostate cancer at epidemic levels.  If the entire U.S. prostate cancer population was experiencing a death rate 2.4 times the current levels, would there not be an all – out urgency to quickly bring to market treatments that could help reduce suffering and extend life? This is the critical condition in Black communities today and it is real.  We are due the same valuation on our lives and urgency of action. Most every African American family today is facing prostate cancer at some level, and the fear and suffering is palpable. We ask that the committee both understand and accept that another important reason for approval of Provenge immediately is because it is needed to help fight the ravages of an epidemic level condition in a segment of our nation’s population. Again I ask, would it be a right or moral decision to deny addressing an epidemic level prostate cancer condition with Provenge, a treatment that has proven to be safe with the ability to help reduce suffering now? What is the benefit in waiting?

 

The prostate cancer survivor community is excited that active cellular immunotherapy could eventually provide a broader range of treatment options to help us fight this disease and maintain our quality of life. We are prayerful that the dawn of this new era will be launched with the immediate approval of Provenge.

 

I appreciate the committee’s consideration of the positions and arguments which I have outlined on behalf of myself and PHEN constituents from across this country.

 

 

Respectfully Submitted,

 

Thomas A. Farrington

President and Founder