On October 28, 2004, the Dendreon Corporation from Seattle, Washington announced the results that showed an immunotherapy had extended the lives of men with late stage prostate cancer.

The standard of care for late stage prostate cancer is chemotherapy. While chemotherapy has helped some men, it is so toxic and has such severe side effects, that most men with late stage prostate cancer refuse to take it. Chemotherapy kills off healthy cells and cancerous cells indiscriminately. Provenge, an immunotherapy, rebuilds the immune system retraining the healthy cells to attack and destroy the invading cancer cells like they did when you were younger.

Provenge affords men with late stage Prostate Cancer the chance of significantly prolonging their survival, while maintaining their quality of life. The side effects from immunotherapy, the strengthening of the body’s own immune system to fight the invaders, are usually no greater than a few days of fever and chills.

All trials show that Provenge is efficacious either by extending survival (D9901 and D9902a) or by extending PSA Doubling Time, PSADT. That amounts to triple the survival rate after 3 years. All six clinical studies following PC patients after Provenge treatment have all demonstrated the effectiveness of Provenge.

On June 29, 2006, Dendreon announced that it had published a pivotal Phase III study highlighting survival benefit and safety profiles of its prostate cancer treatment called Provenge.

On November 24, 2006, Dendreon completed submission of its Biologics License Application to the FDA.

On March 29, 2007, the FDA assembled an Advisory Committee to advise them on whether to approve Provenge. The panel voted Provenge was safe by an overwhelming vote of 17 to 0. They voted Provenge showed substantial evidence that it works by a vote of 13 to 4.

On April 13, 2007, a letter was “leaked” onto the internet via a non-peer medical publication called The Cancer Letter from one of the doctors who voted against Provenge’s efficacy. This prominent New York City doctor, Dr. Howard Scher, who had serious conflicts of interests, vehemently protested the approval of Provenge.

On April 26, 2007, another letter was “leaked” via The Cancer Letter from another conflicted doctor, Dr. Maha Hussain, who also voted against Provenge’s efficacy.

A third letter was “leaked” via The Cancer Letter on May 4, 2007, this time from a non-panel member, denouncing the approval of Provenge.

Finally, on May 8, 2007, the FDA delayed the approval of Provenge by asking for more data. It left 30,000 men without hope.

The “leaked” letters were fraught with inaccuracies (see research page rebuttals to “leaked” letters). CareToLive believes that the “leaked” letters were not the reason for the delay, merely the cover-up that the FDA used to promote the FDA’s own financially and politically conflicted agenda. It is unprecendented for the FDA to overrule such an overwhelmingly positive Advisory Committee of experts to deny a safe and effective treatment to men with a terminal disease where there are no other viable options.

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