We are not fighting this battle alone. Below are some of the actions taken by others to speak up about the delaying in bringing provenge to patients now.

Raise A Voice Writes to FDA Advisory Committee

Raise a Voice, an advocacy group for advanced prostate cancer patients calling for patient access to drugs that have passed through Phase I trials, has written a thank you letter to the FDA Advisory Committee on Dendreon's sipuleucel-T (Provenge®). The letter is signed by 19 prostate cancer advocacy groups including US Too International and National Prostate Cancer Coalition. The writers say:

The advocates of "Raise a Voice", a grass roots initiative for advanced prostate cancer, would like to express our appreciation for the opportunity to present comments at the Cellular, Tissue and Gene Therapies Advisory Committee meeting on March 29, 2007.

We respect and appreciate the importance and difficulty of the FDA's current process towards decision on approval of Provenge (sipuleucel-T).

Given the following points, we would like to reaffirm our position on the need for additional effective treatments with fewer side effects for advanced prostate cancer.

* The very favorable risk-benefit ratio of Provenge
* The survival data discussed at March 29th meeting
* The necessity for additional effective treatments for advanced and hormone refractory prostate cancer based on the current U.S. death rate of approximately 27,000 men a year

Signers of this letters:
1. Us TOO International
2. Prostate Cancer Research Institute
3. Prostate Health Education Network
4. Malecare
5. National Alliance of State Prostate Cancer Coalitions
6. Virginia Prostate Cancer Coalition
7. Georgia Prostate Cancer Coalition
8. Washington State Prostate Cancer Coalition
9. Prostate Cancer Coalition of Michigan
10. National Prostate Cancer Coalition
11. American Prostate Cancer Initiative
12. The Prostate Cancer Education Forum of Connecticut
13. Maine Coalition to Fight Prostate Cancer
14. Nevada's Prostate Cancer Task Force
15. Prostate Cancer Support Association of New Mexico
16. Hawaii Prostate Cancer Coalition
17. Texas Prostate Cancer Coalition
18. Prostate Cancer 101 of New York
19. New York Prostate Cancer Coalition

FDA Delays Approving Cancer Vaccine: Dismayed Prostate Patients To Launch Flood of Protests; A Question of Efficacy
By Marilyn Chase
Wall Street Journal

Patient activists, stunned by a Food and Drug Administration decision to put off approval of a promising new prostate-cancer vaccine, vowed to shower the agency with protest emails as part of a continued push for early access to the experimental treatment.

The FDA late Tuesday asked Dendreon Corp. to provide more data to support the claim that its prostate-cancer vaccine called Provenge works to prolong survival. The company has a 500-patient study now under way to answer that question. But FDA's so-called approvable letter could mean another two years at least until the product reaches patients.

Letter from former NASA employee asking Von Eschenbach to do what he promised

May 11, 2007

Dr. Andrew von Eschenbach
Commissioner, FDA
5600 Fishers Lane
Rockville, MD 20857

Subject: FDA Decision Regarding Provenge

Dear Dr. von Eschenbach,

I am usually not one to write letters to decision makers in our Government, though I served as a civil servant myself at NASA for 32 years. I do have, however, a sense of a public servant's responsibility to the American people whom I served. As a civil servant and the appointed leader of the FDA, charged with promoting the well being of Americans with respect to foods and drugs, I need to request that you explain to the people and their medical doctors why you chose not to approve Provenge, even though you were advised by your appointed panel of Oncologists, Urologists, and Immunologists, all experts in the fields of immunotherapy and oncology, that Provenge is unquestionably safe (100% of the experts voted yes on safety) and that there was "substantial evidence" of the drug's effectiveness as required by FDA regulations (76% of the experts voted yes on substantial evidence of effectiveness). I must add that three of the no votes on efficacy came from three doctors who have conflicts of interest that your agency recognized before appointing them to the panel, and I must ask if they would have even been allowed to participate on the Provenge panel if FDA were now following its new guidelines on conflicts of interest? If no, then the vote without them would have been 13 to 1, or 93% in favor with regard to substantial evidence of effectiveness. I include these percentages since I know FDA is always very interested in statistics!

In walking away from the advisory panel votes on Provenge, I and the rest of older men who expect to do battle with PC, would like a detailed public and scientific explanation of your decision. Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon to be insufficient, why did you even submit the data to a panel of experts for their opinions?

Let me offer several other reasons why a detailed public statement from you, and your personal involvement to achieve a resolution, is absolutely critical at this time. You have made many public promises that FDA would be a "bridge builder" and not a barrier. You could have built a bridge with Provenge by approving it with a post-marketing trial requirement, and allowing combination trials to be initiated with other treatments such as Taxotere. For example, Dr. Petrylak's analysis in The Urology Times in February 2007 pointed to a staggering survival benefit when Provenge is used with Taxotere. In fact, a 14-month survival advantage when compared to Taxotere alone. Surely you were informed of Dr. Petrylak's analysis? And then there is the Dendreon P-11 trial with early stage PC patients, showing a remarkable and clinically significant increase in PSA doubling time exceeding 40%. Surely FDA was told about this clinically significant benefit, were they not? Dr. von Eschenbach, the FDA now says they want to see more data. How much is enough? Would you be turning away from this kind of data if the disease were breast cancer, instead of prostate cancer? Would you?

Dr. von Eschenbach, this decision by FDA can be, if you decide to do so, a bridge-building event. The credibility of FDA with the medical world is at stake here. You can build a bridge by being flexible with Dendreon as to additional data required for approval. Please do something constructive here and do it quickly. Call in Dr. Petrylak, the Taxotere Principal Investigator, and those members of the AC panel who can serve now. Have the company present all of its existing trial data from other trials as well as those submitted thus far. Allow the company to un-blind the on-going 9902b trial data now (and forget about statistical penalties) to examine with you the TTP evidence using updated immunotherapy parameters instead of the outdated chemotherapy parameters that caused the TTP in the first Provenge trial to barely miss statistical significance, and "work with" this company to bring Provenge to market this year. Please don't walk away from this for several more years as we wait for the statistical picture on survival to become more complete. It will never become a certainty. It will always be a probability. Your own statistician said the chance that the observed survival benefit in the completed trials thus far occurring by chance and not by Provenge was only 1 in 50. Is this not enough to give you a reasonable comfort level sufficient to give Provenge to the 80,000 men who will die over the course of the next few years?

You have also told the medical research community that FDA would work to reduce the time and expense to bring new drugs to approval. Surely this must apply to Provenge, a treament for terminally ill cancer patients who have little time to live. Dr. von Eschenbach, please do what you promised to do.

"TEAR DOWN THIS WALL!"

Be the leader we thought you to be. Be courageous. If you need to overrule ODAC and the chemo lobby, then do it. We have no champion but you. We have no voice but yours. Ronald Reagan did it in Berlin. You can do it in Washington.

Will you do the morally right thing and bring this first cancer immunotherapy to the people, even though your understanding of the science is less than perfect? Review again the transcript of the March 29 meeting. Dr. Marincola and Dr. Pensen, who spoke from the public pulpit, urged you to consider the effect of your decision on cancer research. As did others at that table. You also have promised to encourage, not kill, cancer immunotherapies. Please do what you promised, and talk personally to those on the panel who urged FDA to approve Provenge now so new trials could go forward. FDA desperately needs to understand that they must become partners with small biotech companies that cannot go on spending hundreds of millions of dollars and endless years to perfect the trial data beyond any shadow of a doubt. There is no unlimited source of funds. And above all, the law for approving new drugs calls for substantial evidence, not absolute proof, of efficacy.

Become a partner with those whom you promised to serve, and those who depend on your cooperation as a regulator – the research community. These companies' scientists are giving their lives to save others. Surely you can give them your support. We are counting on you to take a leadership role and make it happen…..

God Bless You and Your Staff,

Joseph Sperty
2011 S Conference Dr.
Boca Raton, FL 33486

cc: Jesse Goodman, M.D., Director, CBER
Celia Witten, M.D., PhD., Director, Office of Cellular, Tissue and Gene Therapies

Dendreon's Ups and Downs at FDA and on Nasdaq
Posted by Marilyn Chase
Wall Street Journal Health Blog

Dendreon has taken investors on a stomach-wrenching rollercoaster ride this year. Company shares soared from less than $5 in early January to as much as $25.25 in late March, before trading at $6.11 late Friday.

The stock skidded this week after FDA asked for more data on the company's prostate cancer vaccine, called Provenge. The request could delay the FDA's decision on the vaccine for years and dimmed hopes of both patients and investors. For more click here.