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Fda whistle blower seeks legal help { November 24 2004 }

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November 24, 2004
F.D.A. Employee Seeks Legal Help From Whistle-Blowers' Group

Dr. David J. Graham, the drug safety reviewer who denounced his employer, the Food and Drug Administration, before a Congressional panel last week, said yesterday that he feared being fired and had sought legal help from a group that protects whistle-blowers.

"My concern is retaliation from these people," Dr. Graham said in a telephone interview.

His lawyer, Thomas Devine, legal director of a public-interest group, the Government Accountability Project, said that he had received anonymous telephone calls trying to discredit Dr. Graham and that he believed the calls were from people in "F.D.A. management." His accusations were first reported yesterday in the online version of the British medical journal BMJ.

In response, the drug agency issued a statement acknowledging that an employee had contacted Mr. Devine's group but denying prior knowledge of the contact. The statement also said the agency recognized its employees' rights to raise their concerns to oversight groups and added, "The agency promotes vigorous debate of the tough scientific questions it confronts every day."

Last Thursday, testifying before the Senate Finance Committee, Dr. Graham said the drug agency was "virtually incapable" of protecting the public from unsafe drugs. The hearing was about Vioxx, the popular painkiller and arthritis drug that was taken off the market in September because of cardiovascular risks. Dr. Graham contended that tens of thousands of people had suffered heart attacks or strokes because of the drug, and that the drug agency and Merck, the maker of Vioxx, had failed to act on early signs of trouble.

In his interview, Dr. Graham said he began to realize he was acting as a whistle-blower and to fear for his job last month as he prepared to testify. That concern prompted him to ask Mr. Devine to represent him.

Mr. Devine said that while his organization was considering the request, he began receiving phone calls from people who insisted on anonymity and described themselves as whistle-blowers. More than one person called, Mr. Devine said, but he declined to give the number, saying that could compromise confidentiality, which he had promised to keep.

The callers said Dr. Graham's research was flawed and might include "scientific misconduct." In addition, Mr. Devine said, "Callers further alleged that he was a bully who had been harassing scientists at F.D.A. for years and was a demagogue who manipulated Congress, the media and good-government groups like ours, and he had to be stopped."

Mr. Devine said he took the calls seriously at first, but became suspicious when the callers provided little or no evidence to back up their statements. Dr. Graham easily rebutted the accusations, Mr. Devine said.

The callers, he added, "flunked the tests of credibility, and Dr. Graham passed them."

Mr. Devine began his own investigation and, he said, determined that the callers were higher-ranking people than Dr. Graham. "They were anonymous, but to test my research I started addressing them by their names," Mr. Devine said. "They didn't deny it."

But they reminded him that he had promised them anonymity.

"It was clear that this was a smokescreen, a bureaucratic bluff, and we had called it," he said. Another Congressional panel, the House Energy and Commerce Committee, has requested extensive sets of documents about Vioxx from Merck and the drug agency to find out when the company and agency became aware of potential risks from the drug.

Also yesterday, the drug agency announced that it would tighten its safeguards for prescribing Accutane, the acne drug that can cause birth defects if pregnant women take it. The changes have been in the works since February, the agency said. Dr. Graham mentioned that drug in his testimony last week, saying more controls were needed in its distribution.

Dr. Sandra Kweder, deputy director of the Office of New Drugs at the F.D.A., said the new program would include more stringent monitoring to make sure that women had pregnancy tests every month before renewing prescriptions and that all patients were counseled about risks, include possible effects on mood and suicide feelings.

Copyright 2004 The New York Times Company

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