Unpublished trials data suggest most SSRI antidepressants unsuitable fo...( ithKline memorandum demonstrating how t...),Health

ithKline memorandum demonstrating how the company sought to manipulate the results of published research. Concerning a study of paroxetine use in children, the memorandum states "It would be unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine". Last year the UK Committee on Safety of Medicines prohibited the treatment of childhood depression with any SSRI except fluoxetine. Despite this, the Food and Drug Administration in the US appears last week to have failed to act appropriately on information provided to them that these drugs were both ineffective and harmful'.

'In a global medical culture where evidence-based practice is seen as the gold standard for care, these failings are a disaster. Meta-analysis of published data supports an increasing number of clinical decisions and guidelines, which in turn dictate the use of vast levels of health-care resources. This process is made entirely redundant if its results are so easily manipulated by those with potentially massive financial gains. The global sales of the GlaxoSmithKline SSRI paroxetine, for example, amounted to US $4.97 billion last year alone. Moreover, the utility of organisations such as the National Institute for Clinical Evidence (NICE) is significantly undermined in circumstances where they are only able to access data on health-care products that are seen as advantageous to the product's manufacturers'.

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Contact: Joe Santangelo
j.santangelo@elsevier.com
212-633-3810
Lancet
22-Apr-2004

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