Ella Does Squamish

  Returning to a situation I’ve written about in a couple of prior posts about the contentious saga of the Dendreon (local Seattle company) investigational vaccine Provenge for prostate cancer (posts here and here), three senators have requested a congressional inquiry into the FDA decision to withhold approval of provenge after it had been recommended for approval by an advisory committee to the FDA, as described in a story here.  As described in the second of the posts listed above, this issue was pursued primarily by the group CaretoLive, comprised of prostate cancer advocates and some investors who feel that there was far too much onco-politics in the high level FDA recommendations for who would participate in the final committee, and that two key academic oncologists who served on the committee had potentially significant conflicts of interest that may have denied provenge a completely fair opportunity, and in the process denied prostate cancer patients a potentially helpful treatment.

continued at: 

http://onctalk.com/2007/12/14/request-for-congressional-inquiry-into-drug-approval-process/

I have been following this issue and I am so happy to see that a congressional hearing is likely to investigate the conflicts of interest (COIs) of a couple of the participants on the FDA advisory committee re:  Provenge.  This has only occurred because of the advocacy of the prostate cancer community who were appalled by the FDA decision-making process in this instance.  If I was a journalist, this would make a very interesting book IMO as this scenario outlines how FDA advisory committee members are not neutral/objective, have their own turfs to protect both in terms of ideology/approaches about treatment but also with regard to which companies they are on the boards of, what hedge funds their family members may be representatives of, etc.  It has been an eye-opener for me watching the Provenge saga unfold and I am very thankful that there are people fighting this FDA decision as it stinks of corruption and greed.  

Most of all, that the prostate cancer community has managed to raise such a stink about the delay of Provenge as a treatment for end-stage prostate cancer sufferers, have kept at this issue until it has reached the point of a congressional hearing in the U.S.,  is a tribute to the human spirit that says enough is enough - this is a travesty.