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By Kate Kelland
LONDON, Sept 17 (Reuters) - A medical journal criticisedBritish drugmaker GlaxoSmithKline on Thursday fordelaying access to key data from a trial of its antidepressantSeroxat that would have shown earlier that it is neither safe oreffective in adolescents.
The widely used medicine, known generically as paroxetine,is linked to an increased risk of suicide in young people andhas carried a Food and Drug Administration (FDA) "black boxwarning" advising against its use in adolescents since 2004.
Britain's Medicines and Healthcare ProductsRegulatory Agency recommended in 2003 that antidepressants likeSeroxat should not be used in children or adolescents, andEuropean regulators followed suit in 2005.
But, writing in the British Medical Journal (BMJ),researchers who re-analysed a Seroxat study first published in2001 said the drug's dangerous side effects could easily havebeen highlighted years earlier.
"This is fundamentally about correcting the scientificrecord," said Peter Doshi of the University of Maryland Schoolof Pharmacy in the United States, a BMJ associate editor.
The re-analysis used previously unseen data from records ofpatients involved in the trial and found that at least 12 out of93 children taking the drug had developed suicidal thoughts.
The 2001 Seroxat study, funded by GSK, is the first trial tobe re-analysed under a BMJ initiative called Restoring Invisibleand Abandoned Trials (RIAT), designed to encouragepharmaceutical firms to publish or correct abandoned ormisreported drug trials.
The aim is to ensure doctors and patients have complete,accurate information to make treatment decisions.
GSK's original study was published in the Journal of theAmerican Academy of Child and Adolescent Psychiatry in 2001 andreported paroxetine as safe and effective for adolescents.
GSK -- which in 2012 was fined $3 billion for fraudulentlypromoting several drugs, including paroxetine -- responded tothe BMJ re-analysis by saying it had helped by providing accessto detailed data from the original trial.
"This reflects our commitment to data transparency," thecompany said, adding it had now pledged to publish the resultsof all its studies, whether they are positive or negative.
It also agreed Seroxat should not be given to young people.
"There is an increased risk of suicidality in paediatric andadolescent patients given antidepressants like paroxetine," GSKsaid. "This is widely known and clear warnings have been inplace on the product label for more than a decade."
Doshi argued, however, that the case showed why full patientdata should published alongside original scientific analyses.
"What would have happened if this data were available 15years ago when the study was originally published?," he said."Would the black box warnings from the FDA have come earlier?" (Reporting by Kate Kelland; Editing by Mark Heinrich)
