Here it is June 11 and my frustration with the Prostate Cancer Community continues to climb.
On May 31, I wrote that the FDA had compromised over the issue of the approval of Provenge. At that time, it was announced that the FDA would be willing to use the interim results of Dendreonâ€™s current, on going, clinical trial in their evaluation of Provenge.
This would mean if the results support Provenceâ€™s efficacy the treatment might receive approval by 2008. This willingness to use the interim data would cut the approval process by at least 2 years. This is not ideal, as the immediate approval of Provenge is what the Prostate Cancer Community needs. However, given the reality of the current circumstances, this is the best we will get from the FDA.
This loosening of the requirements by the FDA does not mean that the community should stop the pressure and the protests. We need to let the FDA know that we speak with one, strong voice in our support for the development and approval of new treatments, including Provenge. We all know the current lack of available and approved treatments for men with advanced prostate cancer is both abysmal and disgraceful.
What is surprising to me is the unwillingness within our own Prostate Cancer Community to apply any pressure of any nature, on the biotech industry. We should be screaming to Dendreon to supply us with a Compassionate Use Program while we wait for the approval of Provenge.
I asked that Dendreon step up to the plate in my May 31 post and again I ask that they do the ethical thing and provide us with a Compassionate Use Program.
I also wonder why the leadership of the prostate cancer community, our advocacy groups and our physicians, has not joined the call to convince Dendreon to extend lives now and provide a necessary Compassionate Use Program.
If this were the breast cancer community things would be different. What is wrong with our community and our advocacy groups? Why are not we making as much noise about this issue as we made when we stood against the FDAâ€™s decision.
Our mantra should be â€œProvenge Now and Compassionate Care Nowâ€
Joel T Nowak MA, MSW