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 yesterday.
Tom Devine of the nonprofit Government Accountability Project (GAP) said the anonymous callers did not identify themselves but he is "100 percent positive" they were managers at the FDA because of their phone numbers and other identifying information. He said he initially took the callers' concerns seriously but later came to see the calls as an effort to smear the whistle-blower, Associate Director David J. Graham of the Office of Drug Safety.
David J. Graham, a drug safety official at the Food and Drug Administration, told a Senate hearing that FDA policies have left the American public "virtually defenseless" against the kind of safety problems that led to the withdrawal in September of the popular arthritis drug Vioxx.
(Kevin Lamarque -- Reuters)
Last week, Graham, a 20-year FDA veteran, said at a Senate hearing that FDA policies have 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 pose serious safety risks that are 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 yesterday 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 yesterday 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 is working to improve a process for ensuring that internal differences of scientific opinion are 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."