Understanding the Provenge Trials

On April 29, 2010, the FDA approved Provenge (sipuleucel-t) for the treatment of late-stage prostate cancer . Two months later the FDA issued around 150 of their internal review-related documents to fda.gov. Within these heavily-redacted documents I discovered previously unpublished data from the Provenge trials that were both unexpected and unexplained. It was clear that several of these red flags had been intentionally hidden from the places and publications where they should have appeared. Even after the trial investigators were asked to explain these unexpected results, they were never able to provide explanations, and instead used lies and ad hominem attacks to obfuscate the issues.

I can only assume that the FDA review team missed the red flags in the trial design and trial results because it did not possess the expertise needed to identify them. That is, the team from the biologics division of the FDA (CBER), tasked with reviewing this treatment - a therapy that manipulated the immune system to treat prostate cancer - had members with expertise in neither immunology, nor prostate cancer.

In my opinion, the simplest and most logical interpretation of all the trial data, including the data that had been suppressed, is that Provenge shortens patient survival, yet the so-called "placebo" treatment was even more harmful.

I am the first author of a paper highlighting the unpublished data, and proposing the alternative explanation which was published in the Journal of the National Cancer Institute (a top, peer-reviewed oncology journal), in February 2012. My co-authors include two urologists who are leaders in prostate cancer research, and a professor of immunology with expertise in vaccine efficacy and the impact of aging on the immune system.

The JNCI Paper: Interdisciplinary Critique of Sipuleucel-T as Immunotherapy in Castration-Resistant Prostate Cancer

This video is for anyone wanting to decide for themselves what the facts of the Provenge trials say. It gives the basic background and explanations necessary for someone with a basic science education to understand the arguments on both sides. ~60 mins

                                              Download the script and slides here: UnderstandingProvenge.pdf

The rest of this website provides related information, supplementary details and links to all source materials to aid further research.

After viewing the video, if you would like to help stimulate this long-overdue public debate, please visit the Get Involved page.