GSK TORCH study journal advert ruled promotional and in breach for missing prescribing information (AUTH/1873/8/06)

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Key facts

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Case number	AUTH/1873/8/06
Parties	Scrutiny/Director v GlaxoSmithKline UK Ltd
Material	Journal advertisement featuring the TORCH study (ref SFC/AVL/06/24428/1)
Publication / channel	Hospital Doctor (20 April)
Therapy area	COPD
Products linked (indirectly)	Serevent (salmeterol), Flixotide (fluticasone), Seretide (salmeterol/fluticasone combination)
Main issue	Promotional advertisement without prescribing information
Applicable Code year	2003
Breach clauses	Clause 4.1
Complaint received	01 August 2006
Case completed	03 September 2006 (PDF text also states completed 4 September 2006)
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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During PMCPA scrutiny, a paid-for journal advertisement in Hospital Doctor (20 April; ref SFC/AVL/06/24428/1) promoted awareness of the TORCH (Towards a revolution in COPD health) study.
The TORCH study was sponsored by GlaxoSmithKline and involved three GSK medicines: Serevent (salmeterol), Flixotide (fluticasone) and Seretide (salmeterol/fluticasone combination), plus placebo.
The Authority considered the item a full promotional advertisement that indirectly advertised those medicines, but it contained no prescribing information.
GSK argued the advert was not product promotion and should fall outside the Code (Clause 1.1 scope / Clause 1.2 exclusions), stating it was intended to alert health professionals that results would be available soon and that no results were presented.
The Director determined a prima facie case and progressed it as a formal complaint under Paragraph 18.5 of the Constitution and Procedure.

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The Panel ruled the paid-for space constituted an advertisement and that promoting awareness of a specific company-sponsored study examining company medicines amounted to indirect product advertising.
The Panel ruled the absence of prescribing information was a breach.
Breach upheld: Clause 4.1.
No appeal.

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