Voice Raised At FDA Hearing

Raise A Voice, the grass roots initiative for advanced PC awareness and advocacy, made its first real imprint on the prostate cancer world March 29, 2007 in Maryland. The setting was the FDA’s CBER committee meeting to review the new prostate cancer drug, Provenge® (sipuleucel-T).

Provenge belongs to a class of drugs designed to train the body’s immune system to fight cancer. Recently, in a trial led by Dr. Eric Small from the University of California, San Francisco, Provenge showed improved survival compared to men treated with placebo. Provenge also caused far less side effects than other FDA approved treatments such as chemotherapy. Dendreon, the company that makes Provenge, is requesting that the FDA approve the use of Provenge in asymptomatic, metastatic, hormone-refractory prostate cancer. If approved, Provenge will be the first vaccine type therapy approved to treat prostate cancer.

Provenge is administered in a unique process (see graphic) called leukapheresis in which the blood is filtered, separated, the white blood cells are removed, and a portion retained, with the remainder being returned to the individual. Dendritic cell (DC) precursors are isolated and then incubated with a fusion protein composed of PAP and a DC targeting element. Patients receive 3 doses, each 2 weeks apart.

The CBER meeting is the first step in the FDA process toward full approval for commercial use. CBER meetings are free, open to everyone, and as part of the review process one hour is designated for comments from the public.

Since the public comment session is an important forum for patients and advocates to express their views about a specific drug, Raise A Voice (RAV) made a concerted and effective effort to recruit, coordinate, and even help train speakers for comment. In all, fifteen people gave public comment. Raise A Voice recruited, organized, and helped prepare 10 of those 15 speakers. These speakers were from six different states, and six different prostate cancer organizations. It was a remarkable showing of teamwork by the prostate cancer community. We want to offer special thanks to these speakers, who included:

1.)   Jim Kiefert – Us TOO & Raise A Voice 2.)   Thomas Farrington – Prostate Health Education Network 3.)   Jack Kriney – Raise A Voice 4.)   Michael Bernstein – Raise A Voice 5.)   Joel Nowak – Malecare & Raise A Voice 6.)   James Waldenfels – Virginia Prostate Cancer Coalition (VPCC) 7.)   Ed Grove – Us TOO 8.)   Alvin Chin – VPCC 9.)   Dick Gillespie – VPCC 10.) Jan Manarite – PCRI & Raise A Voice

The last speaker, Jan Manarite, is the PCRI’s Florida Educational Facilitator who organized this effort. Her vision and implementation of the event was inspired by a year of communication with other RAV committee members. In addition to coordinating speakers, Jan was also able to compose and distribute an email to several hundred people about attending the meeting. Phone calls were made to support and advocacy groups in Maryland, Virginia, and Washington DC. Blue lanyards were distributed on behalf of Raise A Voice to anyone who attended the meeting in favor of Provenge. The position statement for Raise A Voice was also displayed and distributed on site. Although it is difficult to say how many attendees were present because of the efforts of RAV, we know that 250 people filled the room to capacity. So many showed up that video feed was required to accommodate the other attendees in the outside foyer.
Jan also composed and distributed an email for others so that they could send comments to the FDA to express opinions about Provenge. These, in turn, were sent out by hundreds of other advocates. The FDA received over 100 such emails, which will eventually be posted publicly at www.fda.gov, under DOCKET # 2007N–0061.

Although it is impossible to measure the impact this will have on the upcoming FDA ruling on Provenge, the RAV effort was felt to be successful by all who participated, and memorable for all who heard the testimony. Skip Lockwood, Executive VP and COO of the National Prostate Cancer Coalition, offered background support for the event, and had this to say about what he observed: “I want to publicly thank PCRI, Us TOO!, PHEN, Malecare, VPCC, and all the survivors who attended and spoke at the FDA hearing on Provenge for some truly wonderful advocacy work. …I would especially like to thank Jan Manarite of PCRI for her tireless pursuit of input, for arranging pre-meetings and for putting together materials to help everyone understand the process and to effectively contribute. This activity was a wonderful example of how advocacy impacts outcomes and it also illustrates what can be achieved by a dedicated group of individuals and organizations…Advocacy is every bit as important as microscopes and DNA in the search to find a cure and NPCC and all of the groups listed here could use more advocates. One lesson that I see taught repeatedly on the lists is that our treatments are in our own hands and that we must work to get the best treatment. In the same way, we all have to work to get the resources to get new treatments and a cure. …Again, thanks to everyone for working together to accomplish and important goal. — Great job.”

Jan Manarite agrees, although she, like the entire RAV team, is disappointed by the delay imposed by the FDA by requesting more clinical data and more information on the chemistry, controls and manufacturing of the application. RAV will continue its efforts.

To join Raise A Voice, or to watch for continued updates

To learn more about Provenge (sipuleucel-T) and to watch for updates, visit www.dendreon.com.

Prostate Cancer Research Institute (PCRI)

Material provided by PCRI is intended for educational purposes for discussion with your physician and should not be considered as medical advice. Information and opinions expressed on this website are not an endorsement by PCRI for any treatment, product or service.