ASHINGTON, Sept. 9 - The chairman of a House
committee angrily accused the Food and Drug Administration on
Thursday of withholding documents on the effects of antidepressants
on children.
Holding a copy of an e-mail message from an agency official
instructing others in the agency not to unearth the documents,
Representative Joe L. Barton, Republican of Texas and chairman of
the House Energy and Commerce Committee, said it demonstrated that
the agency was deliberately defying the panel. He threatened to ask
police officers to go to the agency's offices to retrieve the
records.
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"The F.D.A.'s lack of cooperation with the committee in obtaining
relevant and responsive information in a timely fashion on a matter
that involves the safety of our children leaves me wondering whether
this is sheer ineptitude or something far worse," Mr. Barton
said.
The warning came at a hearing of the Energy and Commerce
Subcommittee on Oversight and Investigations into why the agency and
seven drug makers had failed for years to warn doctors and patients
that most antidepressants have not proved effective in treating
depression in children and that some studies suggest they may cause
some children to become acutely suicidal. In 2002, nearly 11 million
prescriptions for the drugs were given to children, 2.7 million of
them to children under 12.
Mr. Barton said the e-mail message was sent by Patrick McGarey,
an official with the drug agency's Office of Liaison.
Later on Thursday, Jason Brodsky, an F.D.A. spokesman, denied
that the agency had withheld documents. "We have provided all the
information requested by the chairman's letter," Mr. Brodsky said,
adding that the material provided ran to "thousands of pages."
The hearing comes in the midst of a growing controversy about not
only the safety of antidepressant therapy in children but also the
drug industry's longtime tendency to suppress the results of
clinical trials that might undermine the sales of their drugs.
Seven top executives from drug giants like Pfizer, Wyeth and
GlaxoSmithKline were sharply questioned about why the companies had
collectively failed to publish or publicize results of studies
showing that their drugs had not proved effective in treating
teenagers and children.
Late in the hearing, Representative Greg Walden, Republican of
Oregon, read an internal memorandum from a GlaxoSmithKline marketing
executive promoting the results of a study of the drug Paxil as
showing "remarkable" efficacy in treating depressed teenagers and
children. Actually, the study had failed to prove that Paxil was
effective.
Dr. David Wheadon, a senior vice president at GlaxoSmithKline,
responded that he "would not have used these particular words" to
describe the study.
Representative Charles Bass, Republican of New Hampshire, asked
an executive from Forest Laboratories why his company had published
a study that showed a positive outcome for its drug Celexa while
failing to publish - or discuss in the published study - a second
trial that showed no benefit.
Dr. Lawrence Olanoff, a Forest executive vice president, said the
published study was focused entirely on the one positive trial and
was not intended to serve as a survey of other studies.
All the executives said they supported a proposal made this week
by the Pharmaceutical Research and Manufacturers of America, the
industry's trade group, to publicize all clinical trials in a timely
fashion on a collective Web site. But some members of the committee
said that such a voluntary agreement was not enough and that
legislation requiring disclosure was needed. Bills are expected to
be submitted within days in both House and Senate.
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