Congressmen ask committee to explore FDA's Provenge decision as ethics accusations arise

WASHINGTON The House Energy and Commerce Committee is being asked by several members of Congress to investigate why the Food and Drug Administration did not approve Dendreon’s prostate cancer vaccine Provenge.

Earlier this year, the FDA requested more efficacy data for Provenge despite a positive vote from its Cellular, Tissues and Gene Therapies Advisory Committee. The committee voted 13–4 that Provenge was effective and 17–0 that it was safe. However, some cancer experts sent written requests to the agency asking that Provenge not be approved.

According to Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, conflicts of interest on an advisory committee could have contributed to the agency’s decision, “There are reasons to believe that serious ethics rules were violated by two FDA advisory panel members in their decision and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time,” a letter from the lawmakers said.

In the letter sent to committee chairman John Dingell, D-Mich., the three congressmen said that prostate cancer activists have raised questions about two academic medical oncologists, Maha Hussain and Howard Scher, who voted against Provenge on an FDA panel in March.

Scher is a lead investigator for a competing cancer drug made by Novacea. The FDA should not be appointing scientists who are testing a rival drug for another company to an advisory committee, Michaud said, adding that the FDA can and should eliminate conflicts of interest in its advisory committee members to restore public confidence in the agency.

Hussain is an oncologist in the department of internal medicine at the University of Michigan. In an emailed statement, a spokeswoman from the University of Michigan Comprehensive Cancer Center said that Hussain completed the FDA’s paperwork disclosing potential conflicts of interest and a review by the school’s conflict of interest board found that Hussain complied with its policies.

In a statement published on his congressional Web site, Michaud said he believes the “FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge.”

He added that the committee “must examine conflict-of-interest issues with some medical advisors who are chosen to review drug therapies” at the FDA and that “a full disclosure is necessary in order to restore confidence in the FDA.”