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The trials of AstraZeneca

31 Jan, 10 | by Steven Reid, Evidence-Based Mental Health

‘Key opinion leaders’ peddling propaganda for drug companies for a tidy sum, the burial of data on adverse effects from clinical trials, the promotion of new or exaggerated diagnoses to invigorate the market: a series of revelations, legal battles, and even a U.S. Senate investigation over the last year have brought to light the commanding influence that the pharmaceutical industry has over psychiatry. These corrupt practices are of course not exclusive to psychiatry, but it is here that they seem most pervasive.

The latest company in the dock is AstraZeneca facing over 10000 civil claims in the US with allegations that one of its top-selling drugs, the antipsychotic Seroquel (quetiapine), was marketed without warnings about the potential for significant weight gain and the development of diabetes. Adverse metabolic effects, notably obesity, have been a particular concern with the newer antipsychotic drugs so evidence of a reduced risk with Seroquel would give it an edge in a highly competitive market. But there is no such evidence as reported on this weeks BBC Radio 4 programme, File on 4 (if you don’t have access to BBC iPlayer you can read the transcript here). The programme includes an interview with a former medical manager for AstraZeneca in the UK, Dr John Blenkinsopp, who reports that he was expected to approve promotional claims that Seroquel was not associated with weight gain despite trial results to the contrary: “The clinical studies at the time of the launch of Seroquel showed patients developed significant weight gain, significant both statistically and clinically.”

“In the end I was put under quite a significant amount of pressure by the marketeers to sign off claims with regards to the lack of weight gain and I was unwilling to sign that off,” he told the programme, and whilst the drug was marketed in the US with these claims, in the UK there was only one such advertisement placed in the British Journal of Psychiatry in 2004. It stated that Seroquel was “the only atypical with . . . favourable weight profile across the entire dose range.”

And the company’s response? Well, the ad had been targeted at “UK healthcare professionals who would have understood the statement in the broader context of the debate around weight gain and atypical antipsychotics in UK.” It was approved by staff “in the context of available clinical evidence at that time”. Hmmm… AstraZeneca have spent $520 million on settling two federal investigations into the marketing of Seroquel and with more litigation pending, the financial press is speculating that job losses are a likely consequence.

AstraZeneca certainly isn’t the first drug company to be caught out like this. Many of the major companies have settled charges of fraud, off-label marketing and other offences. Calls for tighter regulation and independent trials come and go but we have been here before, and doubtless, we will be here again.

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