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Whistleblower says he fears FDA reprisal

Thursday, November 25, 2004

WASHINGTON -- David Graham says he was surprised by the reception he got back at his Food and Drug Administration office after telling Congress the government had allowed unsafe drugs to remain on the market.

"To be hugged and slapped on the back" was not the welcome he expected from colleagues, he said recently.

But it hasn't been all hugs and kisses since Graham a week ago told the Senate Finance Committee that the FDA had not only fumbled its handling of the arthritis drug Vioxx. It also had mishandled safety questions about five other widely used medications, he testified, setting off a furor within the agency and the pharmaceutical industry.

Tom Devine, legal director for the Government Accountability Project, a whistleblower support organization, said there was a "rabid bureaucratic backlash" that included FDA managers phoning his group accusing Graham of scientific misconduct.

"We checked out the allegations. They were bluffs that flunked the laugh test," said Devine, who has taken up Graham's cause.

The Finance Committee's chairman, Sen. Charles Grassley, R-Iowa, asked the Health and Human Services Department's inspector general Wednesday to investigate whether FDA officials have tried to discredit Graham.

Despite support from colleagues and members of Congress, Graham said on ABC's "Good Morning America" program Wednesday that he fears reprisals.

"I'm caught in the middle of a hurricane, but if I am removed from the Office of Drug Safety, that would be punishment," he said.

"I should not be the issue," Graham told the AP. "Vioxx is the issue. FDA is the issue."

The FDA has filled its Web site with agency rebuttals of Graham's testimony, and drug companies have defended the five products that he described to Congress as posing dangers: Meridia, Crestor, Accutane, Bextra and Serevent. The response has included a national advertising campaign by AstraZeneca PLC on the safety of Crestor.

Despite the rebukes from pharmaceutical makers and FDA superiors, Graham, 50, still hopes to spend the last dozen or so years of his career doing what he's done the past two decades: pointing out drugs with problems.

"Hope springs eternal in the human heart," said Graham, who favors the poetry of e.e. cummings and Robert Frost. "I believe in the work. I have a hope that somehow or another, that some truth will get out."

As a senior safety reviewer, Graham mentors other epidemiology staff, oversees research efforts involving outside databases and serves as a resource for other safety review staffers.

He also is a father to six children, assistant scoutmaster and a wiry long-distance runner turned backpacker who, when flummoxed, begins sentences with an "Oh, golly."

Educated at the Johns Hopkins University School of Medicine, Yale and the University of Pennsylvania, he planned a career puzzling over such neurological maladies as mad cow disease. He turned instead to epidemiology, another field that emphasizes "solving of the puzzle."

For last week's hearing, Graham crafted a sweeping summary of his primary worries about the agency with a mention of a dozen unsafe drugs he'd already pressed the agency to withdraw.

He said he had no intention of adding to the list. But after mentioning there were five other unsafe drugs still on the market, a senator asked him to name them.

"I was afraid if I don't, they'll just get nasty," he said.

"It's almost like he was called on to do this," said Wayne A. Ray, a Vanderbilt Medical Center professor of preventive medicine who was among Graham's co-authors on a project that found increased heart risks with high doses of Vioxx. Until the FDA interceded, that paper was scheduled to be published last week in the journal Lancet.

"I think he saw these cases where it appeared the public health wasn't being protected. And he needed to bring that to everyone's attention," Ray said.


On the Net:

Food and Drug Administration: http://www.fda.gov


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