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 congressmen 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.

   My perceptions on this subject evolved even within the first two weeks that the story really broke.  I knew that Provenge had demonstrated encouraging but not slam dunk results in the pivotal trial that would be the focus of the FDA decision, and was hopeful to have another treatment for my own prostate cancer patients (prostate cancer being my second clinical focus along with lung cancer).  I was disappointed but did not suspect any nefarious activity when the FDA didn’t approve it (they didn’t reject it but postponed any approval until more mature information on the trial became available).  When I heard that patient advocates had sued the FDA and some individuals involved with the decision, I felt disbelief that respected leaders could be called into question.  Then, as questions emerged about conflict of interest, and it appeared that these accusations merited serious attention at the very least, I evolved into a “say it ain’t so, Joe” kind of feeling. 

   The baseball metaphors continue.  As the news breaks from another congressional inquiry, this one about widespread use of steroids in major league baseball, including among some of the most accomplished and respected players, it affects not only our views of the individuals but the integrity of the system.  I try to provide not only my impressions of the best treatments for cancer, but also the evidence to back up those statements.  Oncology strives to be evidence based, but if the system is breached by substantial conflicts of interest subverting the best evidence, it’s terribly damaging to everyone.  This dilemma is now a problem for the field of oncology and our entire drug approval system, beyond the people directly affected by prostate cancer (many) or Dendreon’s stock price (fewer).  This system is predicated on the ability to trust the people who recommend our cancer treatments and approve our drugs to make decisions based on the evidence and unbiased judgment.  Some of the comments that followed my prior posts suggested that I was hopelessly naive.   

   I hope this inquiry is conducted, because the truth needs to be aired.  If it reveals conflict of interest, we need to overhaul the system and integrate more rigorous checks about conflicts (which in truth aren’t only financial - conflicts in the interest of power and celebrity motivate other people, but they generally aren’t captured if you can’t cash them in).  If the key players are exonerated, the inquiry can restore honor where there is now increasing suspicion that the jury is rigged.