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Grassley Defends Whistle-Blower

Senator Asks FDA Not to Retaliate

By Marc Kaufman
Washington Post Staff Writer
Tuesday, November 30, 2004; Page A17

Food and Drug Administration whistle-blower David J. Graham believes he will soon be transferred or fired in retaliation for telling a congressional hearing that the agency is falling short on ensuring drug safety, but his Senate champion is trying to keep that from happening.

In a letter sent yesterday to acting FDA Commissioner Lester M. Crawford, Sen. Charles E. Grassley (R-Iowa) formally asked whether Graham was going to be moved, and made clear that he would regard any reassignment as punishment for Graham's public criticism of the agency.

At a hearing, David Graham said the Food and Drug Administration is not protecting the public from unsafe drugs. (Gerald Herbert -- AP)

"I understand that retaliatory action against dissident employees can come under many guises," Grassley wrote. "Therefore, I . . . request that you 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. Please advise me whether there is any truth to these allegations."

An FDA spokesman said that he could not comment on personnel matters because of privacy considerations.

During his Nov. 18 testimony before Grassley's hearing into the withdrawal of the arthritis drug Vioxx, Graham said the FDA is incapable of protecting the public from similar harmful drugs in the future. Asked by another senator whether other unsafe drugs remained on the market, Graham named five that he considered to be problematic: the diet drug Meridia, the arthritis drug Bextra, the asthma medication Serevent, the acne treatment Accutane and the cholesterol-lowering drug Crestor.

His attorney, Tom Devine of the Government Accountability Project, a whistle-blower protection group, said Graham was offered a transfer to the FDA commissioner's office just before his Senate testimony. Devine said that Graham declined -- saying his life's work was to review the safety of drugs on the market -- but that efforts to move him have continued.

"The reason that Dr. Graham is surviving in his position now is solidarity beyond the call of duty from Senator Grassley and his being in the public spotlight," Devine said. "Without that, he'd be gone."

The federal whistle-blower protection law offers no help because of changes made since it was enacted, Devine said.

During the Vioxx hearing, Grassley told senior FDA officials that Graham should be allowed to continue doing his scientific work on drug safety. Last week, Grassley asked for an Office of the Inspector General inquiry into alleged agency efforts to smear Graham before his testimony.

Devine said that after Graham asked his whistle-blower group for help in October, he received a number of anonymous calls criticizing Graham as personally and professionally irresponsible and calling him a bully. Based on several indicators, Devine said he believes the anonymous callers were managers at the FDA.

In his letter yesterday, Grassley demanded full FDA cooperation with the inquiry into Devine's charges, and an FDA spokesman said the agency would cooperate fully.

Graham has worked in the FDA's Office of Drug Safety for 20 years. Ten drugs he questioned were ultimately withdrawn.

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