AstraZeneca: Seroquel ad claim of “favourable weight profile” ruled misleading (AUTH/2294/1/10, AUTH/2296/1/10, AUTH/2297/1/10)

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Key facts

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Company	AstraZeneca
Medicine	Seroquel (quetiapine)
Cases	AUTH/2294/1/10; AUTH/2296/1/10; AUTH/2297/1/10
Complainants	Journalist; member of the public; ex-employee
Material	Advertisement in the British Journal of Psychiatry (April 2004); BBC online news item and BBC Radio 4 “File on 4” referenced (UK material assessed)
Main issue	Implied/unsupported claim that Seroquel had a “favourable weight profile across the full dose range” and was the “only” atypical with that profile
Applicable Code	2003 Code (considered under 2008 Constitution and Procedure)
Breach clauses	7.2, 7.4, 7.9, 9.1
Clause 2	No breach (Panel); Appeal Board upheld no breach
Case dates (received / completed)	AUTH/2294/1/10: 26 Jan 2010 / 12 Mar 2010; AUTH/2296/1/10: 26 Jan 2010 / 12 Mar 2010; AUTH/2297/1/10: 27 Jan 2010 / 19 May 2010
Sanction	Undertaking received

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Three complaints were made about AstraZeneca’s UK promotion of Seroquel (quetiapine), focused on a British Journal of Psychiatry advertisement (April 2004).
The ad included the claim: “The only atypical with placebo level EPS (including akathisia) and placebo level prolactin concentrations and a favourable weight profile across the full dose range”.
A journalist alleged the ad effectively claimed “no weight gain”.
A member of the public asked PMCPA to review a BBC online news item (“Firm ‘suppressed’ drug test data”, 26 January 2010) referencing alleged pressure on a former medical adviser to approve claims that weight gain was not an issue.
An ex-employee referenced the BBC Radio 4 “File on 4” programme (26 January 2010) and related US media articles; PMCPA limited its consideration to UK material.
AstraZeneca argued the ad was aimed at psychiatrists, did not claim “no weight gain”, and that weight gain was listed as common in the prescribing information; it cited studies (including Arvanitis and Rak 1997; Jones and Huizar 2003; Brecher et al 2000) to support the “favourable weight profile” wording.
The Panel considered that, without explanation, “favourable weight profile” could be read as implying no weight gain or a clear advantage versus other atypical antipsychotics, which was not supported by the data.

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The claim “The only atypical with … a favourable weight profile across the full dose range” was ruled misleading and not substantiated.
Breaches were ruled for misleading/unsupported claims and for failing to reflect evidence on the side-effect of weight gain.
High standards were found not to have been maintained (in the case triggered by the BBC item).
No breach of Clause 2 was ruled (Panel), and the Appeal Board upheld no breach of Clause 2.

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