Back in May, the FDA outraged cancer patients when it delayed the approval of Dendreon's Provenge, a vaccine for prostate cancer. Two months earlier an FDA panel approved Provenge in a 13-4 vote, and though the FDA isn't required to follow the panel's recommendation, it almost always does. The FDA told Dendreon that it would require more data before the vaccine could be approved. Provenge missed the goal of reducing the advancement of cancer but did lengthened survival rates in a small clinical trial.
Now three Congressmen--Rep. Dan Burton (R-IN.); Rep. Mike Michaud (R-ME) and Rep. Tim Ryan (D-OH)--are calling for an investigation of two members who voted against the drug's approval. They contend that academic medical oncologists Maha Hussain and Howard Scher may have a conflicts of interest that interfered with their ability to make an unbiased decision on the Provenge.
"Many ethical questions remain about the two panelists who voted no on approving this drug," Michaud said in a statement. "I believe that the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge... I believe we must examine conflict-of-interest issues with some medical advisers who are chosen to review drug therapies at the FDA. A full disclosure is necessary in order to restore confidence in the FDA."
- see this release from Rep. Mike Michaud's office
- read this Wall Street Journal article