Vioxx, Celebrex, Bextra Recall News

Wednesday, November 24, 2004

Senator demands investigation into Vioxx recall critic

As published earlier in the Vioxx recall blog, Dr. David Graham, a highly respected expert at the Food & Drug Administration (FDA) is being harassed by senior FDA officials to discredit his testimony that the FDA bungled the handling of Vioxx recall.

Sen. Chuck Grassley has asked for an official investigation into whether the Food and Drug Administration has attempted to discredit one of its own drug safety officials who has been critical about agency actions. (Related article: Vioxx recall handling by FDA calls for reforms at FDA)

"Government whistleblowers are patriotic Americans who stick out their necks for the public good. They deserve rewards, not reprisals," Grassley said. Grassley has been conducting congressional oversight of the Food and Drug Administration.

Last week he held a hearing about agency mismanagement of information about cardiovascular risks with Vioxx. The hearing featured testimony from Dr. David J. Graham of the Office of Drug Safety at the FDA. Graham is a 20-year FDA veteran and criticized FDA policies stating that they have left the American public "virtually defenseless" against the kind of safety problems that led to the abrupt withdrawal Vioxx.

Grassley wrote to the Department of Health & Human Services that harassment of Dr. Graham raises substantive questions about whether a number of FDA employees “used deceptive practices against [Dr. David] Graham” and whether those employees acted within the spirit and intent of all applicable laws, including, among others, laws governing whistleblowers and prohibited personnel practices.

According to the Washington Post, the alleged activities involve “managers at the FDA because of their phone numbers and other identifying information.” Grassley continues, "If these allegations indeed have merit, it appears that these activities may have been coordinated by FDA management and may have involved the misuse of government resources, including government property and time."

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