The reboxetine drug trial scandal

Reboxetine is an anti-depressant drug known as a selective noradrenaline re-uptake inhibitor (SNRI). Marketed by Pfizer under the tradenames Edronax, Norebox, Prolift, Solvex and Vestra, it is approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA), the organisation that governs all drugs in the UK. It was first introduced in 1997 and millions of doses are prescribed every year.

It is used in the treatment of unipolar depression and is also used off-label (i.e. prescribed without official approval) for conditions such as panic disorder and ADHD. The drug works by facilitating the release of a chemical called noradrenaline from nerve cells in the brain. Noradrenaline acts to lighten mood, so obviously its depletion may be a contributory factor in cases of depression.

However, the popularity of the drug may have been achieved by means of a scandalously dishonest regime of medical trialling. In his book, Bad Pharma, Ben Goldacre revealed that for every medical trial favourable to reboxetine, there were seven that showed poor results of efficacy. Furthermore, the trials that produced the negative results were effectively suppressed. The trial data available to doctors and regulators revealed fair tests, with overwhelmingly positive results, confirming that reboxetine was better than placebo, and as good as any other antidepressant in head-to-head comparisons. But in October 2010, the Institute for Quality and Efficiency in Healthcare (IQWiG), a German agency responsible for assessing the quality and efficiency of medical treatments, was finally able to bring together all the trials that had ever been conducted on the drug and discovered that seven trials had been conducted comparing reboxetine against placebo. Only one of them had a clear, positive result. You can probably guess – that was the one that got published in an academic journal for doctors and researchers to read. The other six trials, none of which were published, showed that reboxetine was no better than a dummy sugar pill.

The same shocking picture emerged when the researchers discovered and examined trials comparing reboxetine against other drugs. Three small studies, 507 patients in total, showed that reboxetine compared favourably. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data revealed that patients on reboxetine fared worse than those on other drugs.

Then there was the small matter of the side-effects data. The academic literature painted a positive picture, but the unpublished data revealed a very different pattern. It turned out that patients taking reboxetine were more likely to have side-effects and were more likely to withdraw from the trial because of side-effects.

The real scandal about this is not confined to reboxetine. Medical trials that produce negative results are not published because they do not have to be.

More about reboxetine…



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