Many of my prior posts about Provenge have discussed the issue of what appeared to be a conflict of interest of some of the members on the FDA advisory committee that reviewed the drug. When the committee voted to recommend that Provenge be approved, among those members who voted against the approval were Drs. Scher and Hussain.

After the vote was taken Dr. Scher wrote a highly unusual letter to the FDA commissioner asking that the committee’s recommendation be reversed and that Provenge not be approved. The FDA did not follow the advisory committee’s recommendation and Provenge was not approved.

Many advocates as well as many of Dendrion’s investors balked and cried foul. Both Drs Scher and Hussain have been accused of having significant economic conflicts of interest. Many people felt that they should not have been permitted to participate on the advisory committee and certainly should not have been permitted to vote. The perceived foul was then exacerbated when Dr. Scher wrote to the FDA urging the committee’s recommendation reversed.

This afternoon Congressmen Mike Michaud, D-Maine, Tim Ryan, D-Ohio, and Dan Burton, R-Ind. sent a letter to Congressman John Dingell, D-Mich., the chairman of the House Committee on Energy and Commerce, to request the committee conduct a hearing to discuss possible ethics violations and conflicts of interest on the part of Drs. Scher and Hussain.

The congressmen stated that they feel that the actions of these two scientists posed a serious ethical violation. Further, they said that the FDA should not be appointing scientists to advisory committees when they are also the lead investigator of a rival drug nor should the FDA appoint a scientist who is also an adviser to a large investor in such a competitive firm as is Dr. Scher. “It is important that Congress examines possible ethical violations of these panel members considering the viability of potentially important life-saving drugs,” the letter said.

So the saga goes on while we anxiously wait to hear the results from the current Provenge trial. When I was last in Washington I met Dendreon’s Senior Director of Government Affairs, Chris Lockett. I asked Chris how the trials are progressing and if the numbers looked good. He was very noncommittal, but indicated that that things were on track.

Joel Nowak MA, MSW