AUTH/1833/5/06: AstraZeneca v GlaxoSmithKline — CONCEPT study leavepiece found misleading for missing dosing context | PMCPA Case

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Key facts

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Case number	AUTH/1833/5/06
Complainant	AstraZeneca UK Limited
Respondent	Allen & Hanburys Limited (part of GlaxoSmithKline UK Ltd)
Material	CONCEPT study leavepiece (ref SFL/LVP/05/19527/2-FP/July 2005)
Therapy area	Asthma
Products	Seretide (salmeterol/fluticasone) vs Symbicort (formoterol/budesonide)
Main issue	Omission of mean daily dose/mean inhalations and lack of detail on how Symbicort dose was adjusted in practice, making the leavepiece misleading
Breach clauses	Clause 7.2 (x 2) and 7.3 (x 2)
Sanction	Undertaking received
Complaint received	8 May 2006 (HTML page lists 07 May 2006)
Case completed	25 July 2006 (HTML page lists 24 July 2006)
Appeal	No appeal
Applicable Code year	2006

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

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AstraZeneca complained about a promotional leavepiece (ref SFL/LVP/05/19527/2-FP/July 2005) issued by Allen & Hanburys (part of GlaxoSmithKline) about the CONCEPT asthma study.
CONCEPT compared two treatment approaches: fixed maintenance dosing with Seretide (salmeterol/fluticasone) vs symptom-led (variable) dosing with Symbicort (formoterol/budesonide).
AstraZeneca alleged the leavepiece was not fair/balanced and implied clinically equivalent dosing without clearly explaining that Symbicort patients could be stepped down (reported as 82% stepped down to 1 inhalation daily at some point) while Seretide remained fixed.
AstraZeneca also argued the leavepiece did not reflect the balance of evidence (eg, did not refer to the SUND study) and that the symptom-led approach used was not routine in UK practice.
GSK argued the study compared treatment strategies (not like-for-like steroid doses), that dosing was within SPCs, and that CONCEPT was a robust long-term double-blind, double-dummy trial.
The Panel focused on whether the leavepiece gave sufficient information for readers to understand the clinical significance of the results—particularly actual dosing achieved in practice in the Symbicort arm.

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The Panel ruled the leavepiece was misleading because it did not state the mean daily dose of product or mean daily number of inhalations, and gave no details of how Symbicort dosing was adjusted in practice.
Breaches were ruled under Clauses 7.2 and 7.3.
The Panel did not consider that claims such as “Seretide stable dosing achieves superior asthma control compared to formoterol/budesonide symptom led dosing” (about symptom-led dosing per se) were misleading in the way alleged; no breach was ruled on that aspect.
No appeal.

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