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A drug watchdog shows its fangs…at last

25 Jun, 09 | by Steven Reid, Evidence-Based Mental Health

That drug companies play fast and loose with study data is hardly news. It’s a widely-acknowledged problem that has been highlighted particularly with antidepressant trials where the advantage over placebo is often equivocal. Not before time, someone has decided to draw a line: “Deception through concealment is no trivial offence”, says the director of IQWiG – the German version of NICE – as he accuses Pfizer of concealing data about the antidepressant, reboxetine.

IQWiG (The Institute for Quality and Efficiency in Health Care) has ruled that reboxetine has no proof of benefit. They report that the drug has been tested in at least 16 trials but in 9 of them key information is not reported so they are unable to evaluate the effect of the antidepressant on 3000 of the 4600 patients enrolled. What are the implications of their ruling? The watchdog provides an assessment that is used to inform which medical treatments can be reimbursed through the public health insurance system in Germany – Europe’s largest market for drugs.

A rather sniffy spokesman for Pfizer told the BMJ that IQWiG is not a ‘regulatory authority’ but a ‘private institute’ and that there was no obligation to provide them with information. This seems at odds with Pfizer’s own policy on disclosure: “in all cases study results are reported by Pfizer in an objective, accurate, balanced and complete manner and are reported regardless of the outcome of the study or the country in which the study was conducted.”

Reboxetine itself has had a bit of a mauling of late. The Lancet’s recent comparative meta-analysis of 12 newer antidepressants put reboxetine at the bottom of the pile both in terms of efficacy and tolerability. It’s also not available in the US as the FDA turned down the application for a license for reasons which are still unclear. Paradoxically, if this license had been granted current US legislation would have required full disclosure of all the trial data. IQWiG is now calling for a similar European Union-wide legal obligation to publish all trial results as clearly self-regulation by the industry is not working. Corrado Barbui, writing in EBMH, made the same point back in 2007. Isn’t it time to get on with it?

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