Unpublished trials data suggest most SSRI antidepressants unsuitable fo...( e. The investigators...),Health

The investigators comment that increased access to unpublished data from the pharmaceutical industry is crucial to enable a clear picture of antidepressant drug safety and efficacy to emerge. Tim Kendall comments: "The clinical guideline programme developed by NICE [UK National Institute for Clinical Excellence] is underpinned by an evidence-base published in peer-reviewed journals. Although NICE accept submissions of evidence from stakeholders, which might not be published, this acceptance is only done on the understanding that data are made publicly available. Drug sponsors who withhold trial data (or do not make full trial reports available) undermine the guideline programme, which can ultimately lead to recommendations for treatments that are ineffective, cause harm, or both. Others have suggested that the pharmaceutical industry needs greater regulation, and in particular that all trial data-whether published or unpublished-should be fully accessible. In any event, greater cooperation and openness between the pharmaceutical industry and guideline developers, including gaining access to unpublished full trial reports, is clearly a matter of some urgency; this access would allow critical appraisal of study methodology and inclusion of unpublished data that meet recognised standards of quality. The fact that the drugs reviewed here have previously been recommended for use in children on the basis of a very restricted published evidence base can only serve to increase that sense of urgency".

This week's Lancet editorial (p 1335) comments: 'The story of research into SSRI use in childhood depression is one of confusion, manipulation, and institutional failure. Although published evidence was inconsistent at best, use of SSRIs to treat childhood depression has been encouraged by pharmaceutical companies and clinicians worldwide. Last month, the Canadian Medical Association Journal revealed excerpts from an internal GlaxoSm
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Contact: Joe Santangelo
j.santangelo@elsevier.com
212-633-3810
Lancet
22-Apr-2004