Paxil: Questionable Results, Hidden Data

“New documents uncovered by ABC News suggest GlaxoSmithKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil.
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"According to these documents, internal studies by GlaxoSmithKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug.

"In spite of this information, GlaxoSmithKline distributed a memo to its sales force in 2001 touting the drug's 'remarkable efficacy and safety in the treatment of adolescent depression.'"

—ABC News, December 10, 2004, “Drug Maker Withheld Paxil Study Data," contributors: Greg Fisher, Kate Sheekey, Kim Launier and Marc Lallanilla

"Study 329 suggested that the company's popular drug Paxil might help depressed adolescents. Study 377, completed not long afterward, indicated that Paxil provided no more benefit than a sugar pill in treating depressed young people.

"But only the favorable study was widely publicized by Paxil's maker. The company chose not to discuss publicly the trial with negative results, and those findings came to light only when an outside researcher* on the study team decided to disclose them at a medical conference."

—Barry Meier, “Two Studies, Two Results, And a Debate Over a Drug,” June 3, 2004, The New York Times

*Dr. Robert Milin, Royal Ottawa Hospital, Canada