Grassley hits FDA over Vioxx report

Oct. 8, 2004 at 8:54 AM
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WASHINGTON, Oct. 8 (UPI) -- Sometime before Merck pulled its blockbuster arthritis drug Vioxx from the market, U.S. regulators apparently sought to soften a warning about its safety.

Sen. Charles Grassley, R-Iowa, is raising concerns that the Food and Drug Administration pressured a staffer whose research pointed to the cardiovascular risks of Vioxx in August to tone down his wording, the Wall Street Journal reported Friday.

E-mail messages detailing disagreements between the researcher, Dr. David Graham, and other FDA officials have emerged as a key focus of the Senate Finance Committee, which Grassley chairs.

"Instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert," Grassley said in a statement.

Steven Galson, acting director of the FDA's drug center, responded Thursday that "all there was was an exchange of views, which is completely regular and normal." He said Graham did change his conclusions slightly "on his own," but the adjustment didn't "change the thrust of the report."

Graham's research found high doses of Vioxx correlated with risk of a heart attack or sudden cardiac death.

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