Provenge Activists Press Their Lawsuit Against FDA

Even though a federal judge largely dismissed the case recently, the non-profit group that is feverishly trying to get the FDA to approve the Provenge prostate-cancer vaccine is filing an appeal. And the lawyer for the organization, CareToLive, hopes that an emergency briefing and case schedule will soon be approved, leading to a decision within the next three to four months. "We also will be filing a new Freedom of Information Act complaint in the next week or so (with the FDA) unless we receive the documents promised us by the FDA's Office of Oncologic Drugs," Kerry Donahue, the group's lawyer writes us. "The documents were promised to us last week and a call to them indicated they were behind schedule but we should get them soon. They have a few more days, then we file additional litigation."

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.