September 22, 2004: FDA Officials See No Problem with Vioxx

At a meeting attended by several officials and managers of the reviewing office of the FDA, David Graham, who recently presented a paper linking Vioxx to the deaths of more than 27,000 Americans, is asked by the director of the FDA reviewing office why he “even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done,” according to Graham’s later testimony to Congress. Also during the meeting, a senior manager from the Office of Drug Safety refers to Graham’s study as “a scientific rumor.” [US Congress, 11/18/2004 ]