Janssen-Cilag: Risperdal ‘Mania wrecks lives’ mailing and alleged heavy rep activity (AUTH/1842/6/06) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/1842/6/06
Parties	Senior Community Mental Health Nurse / MHRA v Janssen-Cilag
Products	Risperdal (risperidone); Risperdal Consta
Material/channel	Three-page promotional mailing (ref 06799b)
Main issues alleged	Suitability/taste and stigma; distribution to team members and how addresses were obtained; frequency of representative visits and volume of promotional items
Clauses considered	9.2, 12.1, 15.4
Decision	No breach of the Code
Complaint received	2 June 2006
Case completed	7 August 2006
Appeal	No appeal
Applicable Code year	2006
Notes from the case	Panel accepted that increased sexual interest/activity was “not uncommon” in mania (citing Hirschfeld et al) and found the mailing unlikely to offend the majority of the audience; mailing lists compiled by a third party were considered usual; call frequency appeared consistent with Clause 15.4 supplementary information.

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

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A senior community mental health nurse complained (via the MHRA) about a three-page promotional mailing for Risperdal (risperidone) sent by Janssen-Cilag (ref 06799b).
The front cover showed a bedroom scene with two clothed silhouetted figures and text describing a fictional woman (“Tricia”) engaging in risky sexual behaviour, alongside the caption “Mania wrecks lives”.
The complainant said all 16 members of a multidisciplinary mental health team received it and found it “extremely stigmatising”, and said none had encountered a case like the one depicted.
The complainant also queried how names/addresses were obtained (alleging a representative asked a secretary for team names in 2005) and whether that was ethical.
The complainant further alleged very heavy marketing of Risperdal Consta in autumn 2005, with near-weekly visits and distribution of office items (eg diaries, wrist pads, paper shredders).
The MHRA considered the mailing might not be in good taste but was not in breach of the Advertising Regulations; with the complainant’s agreement it was referred to the PMCPA for Code consideration, particularly Clause 9 (suitability and taste).

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No breach of the Code was ruled.
No breach of Clause 9.2 (suitability/taste; recognising the special nature of medicines and professional standing of the audience).
No breach of Clause 15.4 (frequency of representative calls).
No breach of Clause 12.1 (distribution of promotional material only to those whose need/interest can reasonably be assumed).

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