In one development, their lawyer argued before the US Court of Appeals for the Sixth Circuit in Cincinnati that judicial review was required because of a lack of transparency and accountability in the way the FDA decided to delay approval for the Dendreon vaccine after a recommendation by an FDA panel. The activists charge this came amid undisclosed conflicts of interest by two FDA advisory committee members, who quietly wrote FDA offiicals urging a go-slow approach, and Byzantine agency politics involving the head of the oncology drugs office.
"The fact is that the FDA has never stated an official reason why they denied approval to the Provenge (application). We do not know exactly how the decision was made, who made it, how it was made, whether there was a committee, was there a meeting, who attended the meeting or what parameters were the basis of the decision," Kerry Donahue, their lawyer, writes us. (Back story).
Meanwhile, the National Cancer Institute released long-sought documents the activists hoped would help prove their case that officials from the FDA and the NCI conspired to draft the aforementioned secret letter to FDA officials. However, the documents - largely, a string of e-mails - are inconclusive and, not surprisingly, contain redacted portions.
The battle has been largely ignored by the mainstream press and a Congressional committee declined to investigate, partly because the FDA has the right to request more data before issuing approvals and some believe the fight is really driven by angry Dendreon investors. However, the Provenge affair has also figured into the national debate over whether experimental meds should be made available to the fatally ill and raised questions about the FDA's handling of conflicts of interest. So stay tuned.