New York Times, September 10
Lawmaker Says F.D.A. Held Back Drug Data
September 10, 2004
By GARDINER HARRIS
WASHINGTON, 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.
[Fred A. Baughman Jr., MD:
"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.
[Fred A. Baughman Jr., MD:
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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