Dendreon Runs to Daylight

But then a pair of Dendreon presenters took the podium to defend Provenge, and that prompted panel member Robert Samuels of the Florida Prostate Cancer Network to make a passionate and human plea for Provenge's approval, countering the cool, clinical logic offered up by Hussain.

"At the end of the day, this is not about statistics but about patients' lives," said Samuels, himself a prostate cancer survivor. "The panel should take the courageous step and approve [Provenge]. Let doctors and patients make up their own mind."

When the debate ended and voting on the Provenge eficacy question began, it was clear that panel members were struggling with their choice. Had the vote been hurried, through, my sense is that it would have gone against Dendreon, although by a close margin.

That's when things got a bit strange. Celia Witten, the FDA department head in charge of the Provenge review, suggested to the panel chairman that the Provenge efficacy question could be amended. After some back and forth, panel members were asked to decide -- yes or no -- on whether the Provenge clinical data "provided substantial evidence of efficacy."

This was a slightly lower burden of proof, although still strong enough to give the FDA the guidance it needed. When the votes were tallied, the count wasn't close: 13-4 in favor of recommending Provenge for approval.