AstraZeneca breached ABPI Code over Symbicort ad implying improved survival in COPD (AUTH/1853/6/06)

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Key facts

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Case	AUTH/1853/6/06
Complainant	Anonymous hospital consultant
Company	AstraZeneca UK Limited
Material	Journal advertisement (BMJ), ref SYM 06 18758
Product	Symbicort (budesonide/formoterol)
Main issue	Headline “Improving survival in COPD” implied Symbicort improved survival; not substantiated
Panel finding	Misleading implication; claim could not be substantiated
Breach clauses	Clause 7.2 and Clause 7.4
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	26 June 2006 (also reported as 27 June 2006)
Case completed	17 August 2006 (also reported as 18 August 2006)
Appeal	No appeal
Applicable Code year	2006

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

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An anonymous hospital consultant complained about a BMJ journal advertisement for Symbicort (budesonide/formoterol) issued by AstraZeneca UK Limited (ref SYM 06 18758).
The advertisement headline was “Improving survival in COPD”.
Immediately below the headline was a diagram stating that treating 100 patients with Symbicort for 1 year vs formoterol alone could prevent 47 exacerbations.
The complainant alleged AstraZeneca appeared to claim Symbicort improved survival in COPD without evidence (beyond a study with an alternative medicine).
AstraZeneca accepted that the juxtaposition of the survival headline and the exacerbation diagram could be misconstrued as a direct mortality benefit for Symbicort.
The PMCPA Panel considered the ad implied Symbicort in particular had been shown to improve survival in COPD, which was not the case.

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The claim was ruled misleading and not capable of substantiation in the context presented.
Breach found: Clauses 7.2 and 7.4 of the 2006 Code.
No appeal.

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