Provenge – unfairly restricted?

2010 February 19
by Jason Yeh

Over the past couple years, there has been a battle raging to help get the drug Provenge approved by the FDA. Many people have brought up conflicts of interests among FDA panelists as reasons that Provenge has not been made available to the public as of yet.

Last week, Jim Edwards who writes the Pharma Analysis blog over at wrote a piece titled SEC Probe Into Dendreon Cancer Drug “Conspiracy” Could Put Rumors to Rest. In the post, Jim writes:

The conspiracy theorists believe that the FDA was swayed by a “disparaging letter” about Provenge written by Scher to the FDA commissioner, and that coupled with his conflict of interest this maneuvering unfairly kept Provenge off the market — and doomed many men to die unnecessarily from prostate cancer.

On its face, it does look messy: It’s always bad to have people with conflicts of interest in positions of power.

But a closer look reveals that both Scher and Hussain’s conflicts were disclosed prior to their sitting on the panel, and Scher’s letter contains an entirely reasonable and highly persuasive argument for not approving Provenge at the time — the company didn’t have enough data.

In fact, Dendreon had only presented “secondary endpoint” results, not primary endpoints. In other words, they had cherry-picked their data from two studies in which Provenge failed to meet the primary endpoint goals.

Having read this, Frank Burroughs, President of the Abigail Alliance, felt compelled to respond to Jim in a note which I’ve included below.  The Alliance definitely feels like these issues are real and it is important that people understand this fight.

What your article most certainly should have included was the lopsided FDA Oncologic Drugs Advisory Committee (ODAC) panel’s vote infavor of approving Provenge back in 2008.  The ODAC was convinced prostate cancer patients were being helped by Dendreon’s vaccine.

Sadly your article downplayed Drs.Scher and Hussain’s serious conflict of interest.  You should have been critical of the FDA for allowing them to be part of the Provenge review process in the first place.

Let me make one last note.  Even if the FDA wants more data for Provenge and other drugs and vaccines, what is so vitally needed for patients fighting for their lives, who have run out of options, and like so many cannot get into a clinical trial is early access to drugs and vaccines like Provenge, before the final FDA approval.  This is what the Compassionate Access Act will do that is close to being reintroduced in the U.S. Congress.

I think journalism gets measured by the quality of information it presents, not the drama or the pyrotechnics associated with us.         – Bob Woodward

Please respond in comments if you guys have thoughts on this issue.  We’d love to hear it!

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