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Call for congressional hearing on Provenge approval process re-ignites FDA conflict-of-interest controversy

Call for congressional hearing on Provenge approval process re-ignites FDA conflict-of-interest controversy

A call for a congressional hearing has put the FDA drug approval process under scrutiny for possible conflict-of-interest vio-lations. In a letter sent to House Energy and Commerce Committee Chairman John Dingell (D-Mich), congressmen Dan Burton (R-Ind), Mike Michaud (R-Maine), and Tim Ryan (D-Ohio) said, "There is reason to believe that serious ethics rules were violated by two FDA advisory panel members in their decision, and that these decisions played a role in the subsequent decision not to approve Provenge."

Provenge, Dendreon's sipuleucel-T vaccine for treatment of metastatic prostate cancer, was denied FDA approval last year because of lack of data showing improved overall survival.

The Provenge issue was originally pursued by the advocacy group CaretoLive, in a federal lawsuit against FDA commissioner Andrew C. von Eschenbach, MD; Richard Pazdur, MD, head of FDA's Office of Oncologic Drugs; and panel member Howard Scher, MD, chief of the genitourinary oncology service at Memorial Sloan-Kettering Cancer Center.

The lawsuit cited the three for their alleged "improper conduct...and inappropriate actions," among other alleged activities having to do with the decision not to approve Provenge.

However, some leading oncologists say these strong allegations levied against FDA and its advisory panels are driven more by self-interest and passion than by scientific reason.

Defenders of the advisory panel system point out that FDA seeks out the nation's leading experts, and, for good reason, these experts are often the same people sought by pharmaceutical companies as advisors.

"The potential inquiry is very disappointing to me as I think that the physicians on the advisory panel were trying to do the right thing and are being hammered for it. They simply were addressing the results of the study that were presented. I would like to know who sponsored this inquiry and what their conflicts of interests are." Derek Raghavan, MD, PHD, director of the Taussig Cancer Center, told Oncology News International.

Expert panels under fire

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