Controversy is a fact of life for pharmaceutical companies and the Food and Drug Administration, but the ongoing saga of an investigative immunotherapeutic agent for advanced prostate cancer has been unusually contentious.
The struggle to gain FDA approval for sipuleucel-T, to be marketed as Provenge by Dendreon Corp., has been marked by a raucous FDA meeting, picketing in Washington, congressional lobbying, a federal lawsuit, conspiracy theories, conflict of interest allegations, death threats against scientists, investor fury, scientists' indignation, and the use of bodyguards at a major cancer meeting.
A final decision on the drug's approval now awaits interim ...