FDA may reassign Vioxx whistleblower

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A Food and Drug Administration reviewer who criticized the agency’s handling of the now-withdrawn Vioxx painkiller may be forced to another position at the agency, a lawyer for the scientist said Monday.

A Food and Drug Administration reviewer who criticized the agency’s handling of Merck & Co. Inc.’s now-withdrawn Vioxx painkiller may be forced to another position at the agency, a lawyer for the scientist said Monday.

FDA efforts to move David Graham, the associate director for science in the Office of Drug Safety, have stepped up since he accused the agency at a Nov. 18 Senate hearing of failing to protect the public, said his lawyer, Thomas Devine.

“We were wondering if he was going to be reassigned today,” but that had not happened as of Monday morning, said Devine, legal director of the Government Accountability Project. Devine added that talks with other FDA scientists indicate Graham’s ”exile from drug safety work is imminent.”

FDA spokesman Brad Stone had no immediate response to Devine’s comments.

Graham, a 20-year veteran at the agency, sought counsel from the whistle-blower protection group before he testified at the Senate Finance Committee hearing. Merck pulled Vioxx from the market in September after a study found the painkiller can cause heart-related complications and death.

At the hearing, Graham said he felt intimidated by his superiors while preparing his congressional testimony.

Devine said FDA Acting Commissioner Lester Crawford ”aggressively offered (Graham) a post switching from drug safety to long-term management” before the hearing.

If Graham is reassigned, he could challenge the move under the Whistleblower Protection Act but would not likely find refuge because of the law’s inherent weakness, Devine said. ”For all practical purposes, he’ll be defenseless against reprisal,” he said.

The agency has previously said it acknowledges the right of employees to raise their concerns to oversight groups like The Government Accountability Project.

In a letter on Monday, Finance Committee Chairman Sen. Charles Grassley asked FDA’s Crawford to “address allegations that administrative action may be taken against Dr. Graham, including that he may be terminated or transferred against his wishes to a job other than conducting scientific research.”

At the Vioxx hearing, the Iowa Republican told FDA officials he expected Graham’s rights would be upheld and that no retaliation or other similar actions would be taken.

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