Re: Restoring invisible and abandoned trials: a call for people to publish the findings
Following the publication of the Restoring invisible and abandoned trials (RIAT) paper [1], GlaxoSmithKline (GSK) was notified by the RIAT authors by email on June 14 that study 329 was amongst the studies requiring correction. Study 329 was published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry as ‘Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial’[2]. This paper seriously misrepresented the outcomes of study 329, as I and others have extensively documented.
GSK was asked to signal intent to publish a corrected version by sending an electronic response to the RIAT article within 30 days. Since they have not declared their intention to restore the record within this timeframe, I write to declare my intent to work with a team of scientists to republish study 329 of paroxetine in children and adolescents, in accordance with the RIAT guidelines. We plan to use the Clinical Study Report available on the GSK website [3], and other documents relating to Study 329 that are publically available through litigation [4] to prepare a report of outcomes for 93 adolescents treated with paroxetine, 95 with imipramine, and 87 with placebo.
1. Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865
2. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40:762-72.
3. http://www.gsk.com/media/resource-centre/paroxetine/paroxetine-paediatri...
4.http://www.healthyskepticism.org/global/news/int/hsin2010-01
Rapid Response:
Re: Restoring invisible and abandoned trials: a call for people to publish the findings
Following the publication of the Restoring invisible and abandoned trials (RIAT) paper [1], GlaxoSmithKline (GSK) was notified by the RIAT authors by email on June 14 that study 329 was amongst the studies requiring correction. Study 329 was published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry as ‘Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial’[2]. This paper seriously misrepresented the outcomes of study 329, as I and others have extensively documented.
GSK was asked to signal intent to publish a corrected version by sending an electronic response to the RIAT article within 30 days. Since they have not declared their intention to restore the record within this timeframe, I write to declare my intent to work with a team of scientists to republish study 329 of paroxetine in children and adolescents, in accordance with the RIAT guidelines. We plan to use the Clinical Study Report available on the GSK website [3], and other documents relating to Study 329 that are publically available through litigation [4] to prepare a report of outcomes for 93 adolescents treated with paroxetine, 95 with imipramine, and 87 with placebo.
1. Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865
2. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40:762-72.
3. http://www.gsk.com/media/resource-centre/paroxetine/paroxetine-paediatri...
4.http://www.healthyskepticism.org/global/news/int/hsin2010-01
Competing interests: No competing interests