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
Product	Seroquel (quetiapine)
Cases	AUTH/2294/1/10; AUTH/2296/1/10; AUTH/2297/1/10
Complainants	Journalist; member of the public; ex-employee
Material/channel	Journal advertisement in the British Journal of Psychiatry (April 2004); BBC online news item and BBC Radio 4 File on 4 referenced (review limited to UK promotional material)
Main issue	Claim implying Seroquel had a uniquely “favourable weight profile” across dose range; potential implication of no/less weight gain vs other atypicals
Applicable Code	2003 Code (considered under 2008 Constitution and Procedure)
Breach clauses	7.2, 7.4, 7.9 and 9.1
No breach	Clause 2 (no breach; upheld on appeal)
Sanctions	Undertaking received; Additional sanctions: Not stated
Key dates	Complaints received: 26–27 January 2010; Completed: 12 March 2010 (AUTH/2294 and AUTH/2296) and 19 May 2010 (AUTH/2297); Review: August 2010

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

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What happened

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Three complaints were made about AstraZeneca’s UK promotion of Seroquel (quetiapine), focused on a 2004 advertisement in the British Journal of Psychiatry.
The ad stated: “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 alleging a former medical adviser was pressured to approve promotional material suggesting weight gain was not an issue.
An ex-employee referenced a BBC Radio 4 File on 4 programme and US media articles; PMCPA limited its consideration to UK material.
AstraZeneca argued the ad was aimed at psychiatrists, did not say “no weight gain”, and included prescribing information listing weight gain as common; it cited studies (eg 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 evidence.
In the appeal (AUTH/2297/1/10), the complainant challenged the “no Clause 2 breach” finding and raised concerns including AstraZeneca’s inability to produce the approval certificate from its archive; the Appeal Board upheld no breach of Clause 2.

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Outcome

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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 Clauses 7.2, 7.4 and 7.9 (misleading/unsubstantiated claims and claims not reflecting evidence regarding side-effects).
In relation to the BBC item review, the Panel also ruled a breach of Clause 9.1 (high standards not maintained).
No breach of Clause 2 was ruled (and this was upheld on appeal in AUTH/2297/1/10).
AstraZeneca accepted the Panel’s ruling; the complainant’s appeal on Clause 2 was unsuccessful.

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Key facts

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