Unpublished studies change risk benefits of SSRIs in children
Inclusion of unpublished studies in assessing the safety of selective serotonin reuptake inhibitors in children can change the risk benefit profiles of these drugs. So finds a study by UK researchers, including staff from the National Collaborating Centre for Mental Health.
They found that, although published data suggest a favourable risk-benefit
profile for some SSRIs, addition of unpublished data
indicated that risks could outweigh benefits, except in the case of fluoxetine.
The investigators reanalysed data from trials evaluating five SSRIs against
placebo in children aged five to 18 years published in a peer-reviewed
journal. They then extended their analysis to include data from unpublished
trials made available by the Committee on Safety of Medicines.
They comment that increased access to unpublished data from the pharmaceutical
industry is crucial to enable a clear picture of drug safety and efficacy
to emerge.
Author Tim Kendall says that the clinical guideline programme developed
by the National Institute for Clinical Excellence is
underpinned by an evidence-base taken from peer-reviewed journals. He
adds that drug sponsors who withhold data undermine the guidelines programme,
which can ultimately lead to recommendations that are ineffective, cause
harm or both. The authors call for greater openness and transparency
with respect to all intervention studies (Lancet 2004;363:1341-5).
A Lancet editorial on the issue says that the idea of a drug’s
use being based on selective reporting of favourable research should
be unimaginable. It adds that the utility of organisations such NICE
is undermined where they are only able to access data on products that
are seen as advantageous to the product’s manufacturers (ibid 2004;363:1335). |
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