Unpublished data reverses risk-benefit of drugs
16:20 23 April 04
NewScientist.com news service
Unpublished studies on the effects of anti-depressant drugs on children suggest some are both ineffective and potentially harmful, according to a new review of research. The unpublished data contradict published results, fuelling the debate on how pharmaceutical companies reveal trial data.
The new study was conducted by Tim Kendall, deputy director of the Royal College of Psychiatrists' Research Unit in London, UK, and colleagues. One of Kendall's roles is to help analyse medical research to draw up the clinical guidelines on which the UK government bases its drug regulations.
After recent revelations that drug companies have suppressed unfavourable data on their drugs, Kendall and his colleagues contacted pharmaceutical companies requesting unpublished studies that might bear on the guidelines. None of the companies complied, so Kendall contacted a government agency which provided six unpublished studies on three anti-depressants known as selective serotonin reuptake inhibitors (SSRIs).
Kendall and his team added those results to a review of five published studies on the effects of various SSRIs on children.
"When we got the unpublished data and put it in with the published data, something happened. Instead of being safe and effective, the risk-benefit reversed," Kendall told New Scientist.
Suicidal thoughts
Of the five SSRIs reviewed - fluoxetine, paroxetine, sertraline, citalopram, and venlafaxine, only fluoxetine (Prozac) offers more benefits than risks in children. Unpublished studies of venlafaxine, for example, suggested the drug increased suicide-related events such as suicidal thoughts or attempts by 14 times compared with placebo.
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