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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