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
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
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
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
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
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