Understanding the Provenge Trials

On April 29, 2010, the FDA approved Provenge (sipuleucel-t) for the treatment of late-stage prostate cancer (also called hormone-refractory prostate cancer, HRPC, or androgen-independent prostate cancer, AIPC). 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 Within these heavily-redacted documents I discovered previously unpublished data from the Provenge trials that were both unexpected and unexplained.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 Provengeshortenspatient survival, yet the so-called "placebo" treatment was even more harmful.

  • The alternative explanation, co-authored with several leading experts in late-stage prostate cancer and immune aging, was published in the Journal of the National Cancer Institute, in February 2012. The JNCI is a top, peer-reviewed oncology journal.

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.

 

                                    Download the script and slides here: UnderstandingProvenge.pdf

                                    Download a summary of the debate here: DebateSummary.pdf (coming soon)

Aging of the Immune System

In the last decade scientists have significantly advanced our understanding of the many profound ways in which the immune system deteriorates with advanced age. Even many immunologists are unaware of this indisputable body of research. Given the importance of this field to assessing the relative plausibility of the two explanations, the document below (slides & notes) provides a quick overview of some of the most important experimental discoveries and current understanding in the field.

                                    Download Immune Aging Primer here: Immunosenescence.pdf