When a man is diagnosed with prostate cancer he is immediately faced with decisions about treatment options. These decisions center around trade-offs between life saving treatments versus quality-of-life issues caused by the treatments themselves. Of the 230,000 men diagnosed with prostate cancer each year the majority of those undergoing treatment will suffer some level of a diminished quality of life.

For the tens of thousands of men with advanced prostate cancer who are facing the likelihood of death from the disease, the options are chemotherapy or no treatment at all. The severe side effects of chemotherapy makes it impossible for some men to undergo this treatment because of health issues, and other men simply choose to face death as opposed to enduring the side effects of a treatment with slight survival benefits.

Prostate cancer patients from early stage disease diagnosis to late-stage disease pray and hope for new treatments that will provide life saving benefits and preserve their quality of life.

There have been years of research and billions of dollars invested in developing treatments to enhance one's own immune system to fight cancer. The goal is to have this "immunotherapy" treatment effectively fight cancer without the quality of life side effects of existing treatments. PROVENGE® is the first such immunotherapy treatment to reach the FDA for approval for prostate cancer. There is no other such immunotherapy treatment at a stage to go before the FDA approval process. Thus Provenge becomes the symbol for a new era in prostate cancer treatments and beyond.

On March 29, 2007 an FDA advisory panel heard presentations from Dendreon, the company who developed Provenge, the FDA Center for Biologics Evaluation and Research (CBER) and members of the prostate cancer survivor community. After weighing all the data and comments this panel voted to recommend that Provenge be approved now. The recommendation was overwhelmingly positive with a 17 - 0 vote that Provenge was safe and 13 - 4 that it demonstrated substantial efficacy.

Some of the organizations that are part of Provenge Now presented before the FDA advisory panel and observed all of the proceedings first hand. These are some key facts that we would like to highlight:

FACT 1 — The question on the proof of efficacy was initially stated more stringent than the FDA regulatory requirement. After much discussion the question was changed to meet the regulatory requirement. At issue is how was the initial overly-stringent-wording that almost succeeded in derailing the positive vote on efficacy developed.

FACT 2 — Two panel members lobbied the other panel members aggressively to vote no on the question of efficacy. Both of these members were required to sign conflict of interest waivers to participate on the panel. Both were temporary members of the Advisory panel and neither is a specialist in immunology.

FACT 3 — Excluding these two members, the panel voted 13 - 2 on the question of efficacy. They had little effect on swaying other members, some who were specialists in immunology, to accept their arguments. After the positive panel review and recommendation these are facts that we know:

FACT 4 — These two members continued their heavy criticism of the panel positive recommendation citing the efficacy question and the FDA's internal processes as the key reasons that Provenge should not be approved now.

FACT 5 — There are 27,000 men in the United States dying from prostate cancer every year. A delay in making this treatment available will force 27,000 men to die without the opportunity to try a SAFE treatment that could give them a survival benefit. A survey of men with advanced prostate cancer shows that only 52% of the men would take chemotherapy because of the negative impact on their quality of life. Provenge side effects are chills and a flu-like symptom that only lasts a day.

FACT 6 — There has only been one drug in the past 30 years approved for advanced androgen independent prostate cancer that has a modest survival benefit – the chemotherapy treatment Taxotere. Taxotere clinical trial data showed a 2.3 month survival benefit, compared to 4.5 months for Provenge. Provenge is much safer and has fewer side effects.

FACT 7 — "At the heart of all FDA's medical product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great - especially for products used to treat serious, life-threatening conditions." (This statement is from FDA approval process - "http://www.fda.gov/opacom/7approvl.html"

FACT 8 — The FDA never contacted Dendreon after the panel review prior to making their decision not to approve Provenge now, but instead to request additional clinical data.

FACT 9 — A number of financial analysts have questioned publicly whether Dendreon has the financial resources to meet the FDA request, which could require years. A delay in approval puts Provenge, the most promising new treatment for prostate cancer in decades, at risk of ever becoming available.

The Provenge Now coalition STRONGLY believes the FDA's decision process was transparently flawed and influenced by outside interests.

We believe that the interests of prostate cancer patients at every disease stage has been ignored in the blatant public campaigning to influence the FDA decision on approval of a new immunotherapy treatment. Many terminally ill patients are immediately left without a treatment or hope. The Provenge Now initiative intends to give prostate cancer patients a voice in the approval of this new treatment. While we spoke up and were listened to at the advisory panel review, our voices did not carry into the final FDA approval process. Now we will speak louder!

The Provenge Now coalition's position is that the FDA should immediately approve Provenge and accept additional confirmatory data from ongoing clinical trials post approval. We believe that additional data and research post approval will benefit the interests of all parties, and no one can say with certainty today what will be revealed. However, we also believe that to err on the side of perfecting science, FDA process and FDA organizational in-fighting at the expense of terminally ill patients and the dawn of a new era in prostate cancer treatments is inhumane.

Today, men with advanced prostate cancer need MORE TREATMENT OPTIONS. Current options are limited to chemotherapy or death. We need your help, please join our Provenge Now initiative!