Donahue is referring to documents that he hopes will disclose the mysterious origins behind controversial letters written last spring by two FDA advisory panel members, Howard Scher and Maha Hussain, who disagreed with a panel vote to recommend Dendreon's Provenge. In their letters, they urged the agency to take a go-slow approach, and the FDA did, in fact, delay approval by seeking additional studies. CareToLive alleges the effort was part of a Byzantine, behind-the-scenes power play orchestrated by Richard Pazdur, who heads the FDA's Office of Oncologic Drugs. (Who was involved in the letter writing? Look here).
For months, this lawsuit, which harshly accuses the FDA of violating its own policies and turning its bureucratic back on cancer patients, has generated little attention and, in fact, was largely seen as a desperate ploy by desperate people who have also staged futile rallies (see picture). Now, though, the effort may gain more attention after three congressmen wrote the House Energy & Commerce committee seeking an investigation into the FDA's handling of Provenge and allegations that the two panel members had undisclosed conflicts of interest. And so, we will continue to keep you posted.