Antidepressant Ineffective & Harmful


Antidepressant 'ineffective and potentially harmful'

An antidepressant prescribed to about 5,000 people in England at a cost to the NHS of almost £900,000 a year is "ineffective and potentially harmful", academics have concluded.

They discovered that reboxetine, marketed as Edronax by Pfizer, was no more effective at countering major depression than a placebo sugar pill, after studying all available data on the drug.

In the study, published in the British Medical Journal today (WED), the German researchers found that some trials which failed to show reboxetine worked well were not submitted for publication by academic journals.

This, they said, was "a striking example of publication bias" - where academics or drug companies decide not to publish unfavourable results in peer-reviewed journals.

Overall, data on nearly three in four patients who took the drug went unpublished, claimed the researchers, working for the German Institute for Quality and Efficiency in Health Care.

"Data on 74 per cent of the patients included in our analysis was unpublished, indicating that the published evidence on reboxetine so far has been severely affected by publication bias," they wrote.

If all the studies were taken into account - both published and unpublished - then the evidence showed that the risks of taking the drug outweighed the benefits. Their analysis found that those who took reboxetine were more likely to have "at least one adverse event" than those given a placebo. However, there was no significant difference in the rate of suicide attempts between the two groups. They noted that guidance issued by Britain's National Institute for Clinical Excellence (Nice), that "reboxetine is superior to placebo and as effective as other antidepressants" was in their opinion, a conclusion that "can no longer be upheld".

A spokesman for Pfizer said: "Pfizer discloses the results of its clinical trials to regulatory authorities all around the world. These regulatory authorities carefully balance the risks and benefits of each medication, and reflect all important safety and efficacy information in the approved product labelling.

"Pfizer will review the meta-analysis relating to reboxetine published in the British Medical Journal on 13th October 2010 in detail and will provide further comment after completing the review."

By Stephen Adams, Medical Correspondent


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