The inimitable 1 Boring Old Man stumbles on previously unreleased raw data from GlaxoSmithKline’s controversial study of paroxetine in adolescent depression (study 329). The data had been ordered to be released as part of a Paxil lawsuit that had been settled in 2004. 1 Boring Old Man finds that a comment from the first analysis states “the results of the studies were disappointing in that we did not reach statistical significance on the primary end points and thus the data do not support a label claim for the treatment of adolescent depression. The possibility of obtaining a safety statement from this data was considered but rejected.”
