October 13, 2010

expert reaction to BMJ paper on the effectiveness of Reboxetine for acute treatment of major depression

The British Medical Journal published research looking at published and unpublished data into the effectiveness of the anti-depressant Reboxetine.

Dr Anthony Cleare, Consultant Psychiatrist and Head of the Affective Disorders Unit at the Maudsley Hospital and Institute of Psychiatry, King’s College London, said:

“It is not acceptable to be shown only positive data. Clinicians treating patients with depression absolutely need the full picture in order to help their patients make the right choices about the various treatments that are available – and this applies to all therapies not only antidepressant medication.

“It is important though not to throw out the baby with the bathwater – the current study only applies to one specific type of antidepressant, and one which has not been widely prescribed due to clinical perceptions of poor results (perhaps now justified). There is good evidence that patients with depression, particularly more severe forms, do respond well to other types of antidepressants.”

Prof Nick Craddock, Professor of Psychiatry, Cardiff University and Scientific Advisor to MDF – the Bipolar Organization, said:

“The need for mandatory disclosure of clinical trials results is an issue for all medicines, not just those used in psychiatry.

“This study confirms the previous findings that reboxetine is much less effective than other antidepressants.”

Prof Phil Cowen, Professor of Psychopharmacology, University of Oxford, said:

“Anyone involved in the assessment of drug treatment would endorse the call that all trial data must be made publically available for independent analysis.

“However, even when all the data are in, meta-analyses can still disagree as is shown by the contrasting conclusions of the present study with that of Papakostas and colleagues on the relative efficacy of SSRIs and reboxetine.

“Another problem, particularly with antidepressants, is the difficulty of interpreting effectiveness from placebo-controlled trials which are often far removed from clinical practice. The fact that reboxetine seemed more effective in severely ill inpatients than outpatients is a good illustration of this problem.”

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“Publication bias is a well-known problem but perfect solutions are not as easy as some suggest. Freemantle is right – it is complex to access & interpret these very massive databases. Transparency is important but you cannot legislate to obtain integrity. The specific issue of reboxetine is concerning and requires European review. There are moves towards benefit as well as harm review after marketing, and again, while laudable are not always easy. Resources to do this independently will need taxpayer support in a difficult climate.”

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trial, Dirk Eyding et al., published in the BMJ, 13 October.