AUTH/1840/5/06: GSK restless legs syndrome (RLS) patient poster – no breach (Clauses 20.1, 20.2) | PMCPA Case

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Key facts

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Case number	AUTH/1840/5/06
Complainant	Primary care trust pharmacist
Company	GlaxoSmithKline UK Ltd
Material	Patient poster on Restless Legs Syndrome (ref RLS/PSR/06/25194/1)
Setting / audience	Issued to GP practices for display; aimed at the general public
Key message	If “yes” to symptom questions, readers “might have RLS”; advised to ask their doctor for advice
Distribution	14,000 practice managers and 4,500 secondary care physicians
Clauses considered	20.1 and 20.2
Decision	No breach
Complaint received	30 May 2006
Case completed	5 July 2006
Appeal	No appeal
Applicable Code year	2006

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

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A primary care trust pharmacist complained about a GlaxoSmithKline (GSK) poster for display in GP practices aimed at the general public.
The poster asked: “Do you suffer from Restless Legs Syndrome [RLS]?” and included four symptom questions (eg “Do you have an urge to move your legs?”; “Is it worse in the evenings or at night?”).
It stated that if readers answered “yes” to all questions they “might have RLS” and advised them to ask their doctor for advice.
The GSK logo appeared on the poster; the poster reference was RLS/PSR/06/25194/1.
Distribution stated: 14,000 practice managers and 4,500 secondary care physicians.
The complainant alleged the poster was inappropriate/misleading, implied diagnosis before GP review, and would drive patients to seek treatment (including pharmacological treatment) when many cases could be managed non-pharmacologically.
The complainant linked the activity to GSK’s recently launched Adartrel (a prescription only medicine) and raised concerns including black triangle status and the MHRA Blue Guide.
The PMCPA asked GSK to respond under Clauses 20.1 and 20.2.
GSK denied the poster advertised a POM, said it was disease awareness only, contained no management/treatment recommendations, and did not prompt requests for any specific medicine; GSK also noted Adartrel was not the only licensed treatment for moderate to severe RLS (pramipexole/Mirapexin had an MA earlier in 2006).

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No breach of the Code was ruled.
No breach of Clause 20.1: the Panel considered the poster raised awareness and might facilitate market development, but did not promote a prescription only medicine to the public.
No breach of Clause 20.2: the Panel accepted it might encourage patients to ask their doctor for advice about RLS, but it did not encourage them to ask for a specific prescription only medicine.

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