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Published on 13 October 2010

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All drug data ‘should be published’

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Pharmaceutical firms should have to publicise every last bit of data from drug trials instead of being allowed to select parts of it to support whatever claims they are making, experts say.

A review of test results for anti-depressant Edronax showed that Pfizer only published a small amount of data for the medication. Reviewers said the anti-depressant is actually “ineffective and potentially harmful”.

Edronax is still being prescribed to people in the UK and other European nations but is not available in the US.

The experts, writing in the online version of the British Medical Journal, reviewed findings for the drug versus a placebo and other anti-depressants, known as selective serotonin re-uptake inhibitors.

They also measured the impact of “publication bias” in clinical trials of reboxetine carried out for predecessors of Pfizer, which makes Edronax.

Publication bias refers to positive trial results being more likely to be published than those that are unfavourable.

In an accompanying editorial, the experts argue for full disclosure of all trial results.

“It is generally agreed that regulatory authorities need to have access to the complete data on drugs, and extensive regulation guarantees this access.

“In contrast, there is insufficient regulation on the evidence required to make health policy decisions after approval, even though these decisions have a considerable effect on the treatment of patients.

“Furthermore, although regulatory authorities hold the relevant trial data, they often cite confidentiality laws as a reason for denying policy makers and other parties access.”

Stephen Evans, Professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said: “Publication bias is a well-known problem but perfect solutions are not as easy as some suggest.”

Copyright Press Association 2010

British Medical Journal



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