AUTH/2105/3/08: Anonymous doctor v Procter & Gamble (Asacol) — patient recruitment poster (no breach) | PMCPA Case

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Key facts

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Case number	AUTH/2105/3/08
Complainant	Anonymous doctor (non-contactable)
Company	Procter & Gamble Pharmaceuticals UK Limited
Product	Asacol (mesalazine)
Issue	Alleged promotion of Asacol to the public via a hospital poster recruiting for the CODA trial (“Once daily Asacol”)
Company involvement	Educational grant funding only; no role in poster creation or placement (poster produced by NHS trust sponsor; REC approved)
Applicable Code year	2006
Clauses considered	2, 9.1, 20.1, 20.2
Decision	No breach of Clauses 2, 9.1, 20.1 and 20.2
Complaint received	13 March 2008
Case completed	9 April 2008
Appeal	No appeal

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

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An anonymous doctor complained about a poster in a hospital outpatients department recruiting patients to the “CODA Trial – Colitis: Once daily Asacol”.
The complainant said the poster led to numerous patients asking for a once-daily prescription of Asacol (mesalazine), creating lengthy discussions with patients who were not eligible for the trial.
The complainant believed Asacol was not licensed for once-daily use (SPC stated maintenance therapy: three to six tablets daily in divided doses).
The complainant alleged the poster targeted the public (placed in a patient waiting area) and implied better compliance (elephant image; highlighted words), giving “false hope” and causing tension between patients and clinicians.
Procter & Gamble (P&G) stated it did not sponsor the trial and had no role in producing or placing the poster; its involvement was limited to an educational grant.
The trial sponsor was an NHS trust, which independently produced the poster; wording was reviewed/approved by the Research Ethics Committee (REC). Site recruitment contact details were for a hospital clinical nurse specialist, not P&G.

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No breach of the Code was ruled.
The Panel decided P&G was not responsible for the poster because it was independently produced and placed by the NHS trust running the study.
The Panel noted sympathy with the complainant’s concerns and commented that patient recruitment materials should not inadvertently advertise prescription-only medicines to the public or encourage requests for a specific POM.

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