Raise A Voice – Advocacy
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Raise A Voice Mission

Raise A Voice for Advanced Prostate Cancer Advocacy is a grassroots initiative of the prostate cancer community to bring awareness to the plight of men who are struggling with progressive disease. Many people believe that few men die of prostate cancer but about 30,000 do and 48,000 more are dealing with hormone refractory disease. The initiative has two primary objectives:

  • Earlier access to promising treatments prior to final approval that have successfully passed safety studies (Phase I), for patients who do not qualify for clinical trials.
  • Increased public awareness of the plight of men with progressive advanced prostate cancer.

This effort is ongoing. A draft position statement produced by the organizing committee is now available for review.

The organizing committee appeals to prostate cancer organizations and individuals to step forward and support the initiative. We need signatures and we need assistance in presenting this viewpoint to the public.

Advocates must be recruited and trained in both advocacy and the science of the disease. They must stay on top of the latest research to be credible.

If you feel a passion to join in Raise a Voice for Advanced Prostate Cancer, send an email with your name, address and phone number to: raiseavoice@comcast.net.

Raise A Voice Public Activities

March – June 2007

RAV provided information to the public related to the FDA application for Provenge and facilitated public comment at the March 31st meeting of the FDA Advisory Committee. See:

Provenge Review by FDA

Voice Raised At FDA Hearing

RAV coordinated a public rally in Washington DC on June 4th to protest the FDA decision that delayed the approval of Provenge. See:

RAISE A VOICE CONTINUES TO BE HEARD

July 2007

RAV provided information to the public related to the FDA application for Satraplatin and facilitated public comment at the July 24th meeting of the FDA Advisory Committee. See:

Satraplatin Review by FDA

Beginnings of the initiative

The Advanced Prostate Cancer Advocacy Meeting was held February 23, 2006 in San Francisco before the 2006 Prostate Cancer Symposium. There were attendees from several prostate cancer organizations, prominent experts in the disease and representatives of the AIDS and Breast Cancer movements.

The results of this meeting were reported in May 2006 in both the PCRI Insights and the UsTOO Hotsheet.

The organizing committee reviewed the initiatives of several other current organizations regarding access to drugs. For a perspective on other activities, a few references include:

The NCCS / ASCO Citizen’s Petition was delivered to the FDA on March 27, 2006. Of note:
1) The petition supports the use of Extended Access Programs, limitations on the use of single patient IND’s (Investigational New Drug) and broader use of IND’s.
2) There is no call for a public forum to discuss or gain advocacy opinion about this issue; rather the petition calls upon the FDA to provide guidance on EAP’s.
3) The petition states that patients can be charged for drugs not yet approved
4) It requests payment for physicians who manage patients in EAP’s.
Our concern is the potential consequences of 3 and 4, and allowing the FDA to determine guidance on these important issues without a call for a public hearing. The full petition is available at:
http://www.canceradvocacy.org/advocacy/

Another citizen’s petition was filed by the Abigail Alliance. This petition calls for a totally revamped FDA approval process. This process is similar to the call by Dr Stephen Strum at the National Prostate Cancer Conference in June 2005. This petition is available at:
http://www.abigail-alliance.org/

This effort resulted in Senate 1956 Bill to Amend the FDA to create a new three tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. This bill was introduced by Senators Brownback (KS) 11/3/2005, read twice and referred to the Senate committee on Health, Education, Labor and Pensions. The bill can also be viewed at:
http://www.abigail-alliance.org/

Access before Approval — A Right to Take Experimental Drugs?
Susan Okie, M.D. New England Journal of Medicine
Volume 355:437-440 August 3, 2006 Number 5
http://content.nejm.org/cgi/content/full/355/5/437?query=TOC

History of Regulation of, and Rights to Access to, Drugs in the United States.
http://content.nejm.org/cgi/content-nw/full/355/5/437/T1

The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients. This paper reviews Senate bill S.1956 and provides arguments supporting the current clinical trials process. The SCT membership includes representatives of academia, the pharmaceutical industry and the government. (added 8/21/06)
http://www.sctweb.org/positionpapers/S.1956-clinical-trials.pdf

 

PCRI staff members are participating in the organization of this initiative and PCRI provides this information as a public service to the organizing committee and the prostate cancer community.