Senator Asks FDA Not to Retaliate

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Grassley Defends Whistle-Blower

Senator Asks FDA Not to Retaliate

http://www.washingtonpost.com/wp-dyn/articles/A20662-2004Nov29.html

 

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.