The rules of retraction

Years after regulators banned GlaxoSmithKline’s antidepressant paroxetine (Seroxat) for under-18s, two academics are fighting for a paper claiming the drug is safe and effective for adolescents to be withdrawn.

The 2001 paper in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP)1 concludes that paroxetine is “generally well tolerated and effective” for treatment of major depression in adolescents.

The paper gives a misleading impression of the trial’s results and the journal should retract it, say Jon Jureidini, associate professor of psychiatry at the University of Adelaide, and Leemon McHenry, lecturer in philosophy at California State University.

The efficacy claim was based on just 15% of the trial’s outcomes, they argue.

The academics’ stance is supported by internal GSK documents released during personal injury lawsuits against the company. The documents show that company employees and public relations advisers also saw the trial data as having failed to prove that the drug worked in adolescents.

Despite this, JAACAP’s editors maintain that as the paper contains no inaccuracies and negative findings are included in a results table, there are no grounds for its withdrawal.

“Evidence about medicine will be reliable only if the sponsor company and investigators design, conduct and report the results of clinical trials with integrity,” say Jureidini and McHenry.

The cases of rofecoxib,2 rosiglitazone,3 and gabapentin4 have shown how marketing objectives can influence scientific testing.

The pair believe that journal editors are too reluctant to retract papers when the extent of this influence is revealed. Editors are “jeopardising their scientific standing and moral responsibility to prescribers and patients,” by failing to retract, they argue.

A recent Thomson Reuters analysis …