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Drug trial claims 'misleading'

13th October 2010

Experts writing in the British Medical Journal have suggested that doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published.

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They have called for the pharmaceutical industry to publish all data, not just positive findings.

The team used the example of the antidepressant reboxetine, which is made by Pfizer and used in many European countries including the UK.

They say publications have failed to show the drug in a true light and its rejection by US drug regulators raised doubts about its effectiveness leading to questions about missing data.

Elsewhere, GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.

The researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for reboxetine that should be made public because it could change views about the drug.

Writing in the BMJ, they say the findings "underline the urgent need for mandatory publication of trial data".

The MHRA said: "There is a European initiative to provide public access to the results of clinical trials. The currently planned timeline is that this information could become available in 2011/12."

Pfizer said reboxetine is licensed in the UK for the acute treatment of depressive illness and that it presents an effective treatment option.

A spokesman added that Pfizer discloses the results of its clinical trials "to regulatory authorities all around the world" who "carefully balance the risks and benefits of each medication".

 

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