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Whistler-Blower Guardians Say FDA Officials Tried to Undermine Critic
Published on Wednesday, November 24, 2004 by the San Francisco Chronicle
Whistler-Blower Guardians Say FDA Officials Tried to Undermine Critic
by Marc Kaufman
 

WASHINGTON - Managers at the Food and Drug Administration last month anonymously called a group that protects whistle-blowers in an attempt to discredit an outspoken agency safety officer who was challenging the FDA's drug safety policies, the legal director of the whistle-blower group said Tuesday.

Tom Devine of the nonprofit Government Accountability Project (GAP) said that the anonymous callers had not identified themselves but that he was "100 percent positive" they were managers at the FDA because of their phone numbers and other identifying information. He initially took the callers' concerns seriously, he said, but later came to see the calls as an effort to smear the whistle-blower, Associate Director David Graham of the Office of Drug Safety.

In startling testimony last week, Graham, a 20-year FDA veteran, said at a Senate hearing that agency policies had left the American public "virtually defenseless" against the kind of safety problems that led to the abrupt withdrawal in September of the popular arthritis drug Vioxx. He named five other prescription medications that he said posed serious safety risks that were not being adequately addressed by the FDA.

Although the FDA initially sharply criticized Graham's testimony -- one top official called him irresponsible and a practitioner of "junk science" -- the agency Tuesday tightened the restrictions on one of the five drugs Graham had criticized, the acne medication Accutane.

In a statement regarding the GAP allegations, the FDA said Tuesday that it "acknowledges the right of its employees to raise their concerns to oversight groups."

The agency said that it had no prior knowledge of any employee's contact with the whistle-blower group and that it was working to improve a process for ensuring that internal differences of scientific opinion were fully incorporated into its decision-making. "The agency promotes vigorous debate of the tough scientific questions it confronts every day," the statement said.

The allegation that the FDA used deceptive practices against Graham came two days after the Government Accountability Project agreed to take him on as a client.

Devine said Graham had asked five weeks ago for advice about overcoming his supervisors' opposition to the publication of his critical findings about Vioxx. The anonymous calls followed several weeks later, Devine said.

"The calls came under the guise of being anonymous whistle-blowers," Devine said. "They were clearly working together and shared allegations -- mostly that Dr. Graham's research was unreliable and that there were serious questions of possible scientific misconduct with his study. They said Graham wouldn't address their concerns, and that he was a demagogue and a bully."

After several conversations, Devine said, he persuaded the callers to provide documents to support their accusations, and Devine then challenged Graham based on what was provided.

"It became clear to me that Dr. Graham could reasonably explain any questions about the research and that the callers were trying to smear him," Devine said. "After that, I called their bluff for more information, and that was the end of it. It was all a red herring, and it made me believe Dr. Graham far more."

Devine said that, under his organization's rules, he could not identify the callers because they had initially contacted GAP as whistle-blowers themselves. But he said he was certain they were supervisors at the FDA because of the details of the arguments they made and the phone numbers from which they called.

In addition, he said, after identifying the callers to his satisfaction, he referred to them by name during subsequent phone conversations. He said the callers were surprised by his identifications but did not tell him he was wrong.

The allegations follow weeks of bruising criticism of the FDA, which has been accused of being lax on drug safety and was sharply assailed in Congress over its oversight of the British plant that was supposed to produce half of this winter's U.S. supply of flu vaccine. The plant was closed by British health officials because of contamination problems.

The criticism on drug safety issues has led to calls for the creation of a more independent Office of Drug Safety within the FDA or, perhaps, outside of it.

© Copyright 2004 San Francisco Chronicle

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