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Lawmaker Says F.D.A. Held Back Drug Data

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. Here, we have the FDA protecting big pharma, allowing, enhancing, the victimization of US children--our children, our normal children.  Consider this with the White House initiative for mandatory screening--all you have to know to understand why public schools harbor danger for our children and families.

"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. think of it: "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.