U.S. FDA Tried to Block Vioxx Results

From Medscape: (subscription required)

WASHINGTON (Reuters) Oct 08 - U.S. Food and Drug Administration officials pressured an agency safety official to keep quiet or water down his findings that the now-withdrawn arthritis drug Vioxx was dangerous to the heart, a leading Senate Republican charged on Thursday. Senate Finance Committee Chairman Charles Grassley said he interviewed FDA scientist David Graham as part of the committee's probe of how the agency handled the Merck & Co. Inc. drug, which the company pulled a week ago. According to a statement from Grassley, Graham said he had been "ostracized" and subject to "veiled threats" and "intimidation" from within the FDA when he tried to get his research published in the weeks before Merck acknowledged Vioxx's risks. FDA officials could not immediately be reached for comment on Thursday evening. Graham, associate director for science in the FDA's Office of Drug Safety, concluded that patients who took Vioxx had a 50-percent greater chance of heart attacks and sudden cardiac death than people who took Pfizer Inc.'s rival medicine Celebrex. When an FDA official suggested Graham water down his findings, Graham wrote, "I've gone about as far as I can without compromising my deeply held conclusions," according to Grassley. On August 12, one of Graham's supervisors wrote that Merck "needs to know before it becomes public so they can be prepared for extensive media attention," Grassley said. Graham's conclusions were presented at a conference in France on August 25. Merck withdrew Vioxx after the company's own three-year study found higher heart attack and stroke risks for people who took the painkiller, compared with others who took a placebo. "Instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert," Grassley said. The treatment of Graham was similar to the agency's handling of warnings from another FDA scientist, Dr. Andrew Mosholder, that antidepressants increased the chances of suicidal behavior in children and teens, Grassley said. FDA officials prevented Mosholder from presenting his conclusions at a public meeting, saying they disagreed with him. Last month, the agency acknowledged a link between the antidepressants and suicidal behavior. "In both cases, what looks like foot-dragging by the Food and Drug Administration is downright alarming," Grassley said.

Before you touch that "x" next to Bush's name on Nov. 2, think: Is the Bush Administration acting in your best interests, or in the interests of their corporate campaign contributors?