AUTH/2008/6/07: ProStrakan – Rectogesic “Advertisement Feature”, SPC-inconsistent algorithm and breach of undertaking | PMCPA Case

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Key facts

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Case number	AUTH/2008/6/07
Parties	Member of the public/Director v ProStrakan
Product	Rectogesic (glyceryl trinitrate (GTN) rectal ointment)
Issue	Breach of undertaking and promotion via sponsored “Advertisement Feature”/Quick Guide; SPC-inconsistent algorithm; missing prescribing information
Complaint received	06 June 2007
Case completed	09 November 2007
Applicable Code year	2006
Breach clauses	2, 3.2 (x 2), 4.1 and 22
No-breach elements	Alleged undertaking breach for historic materials on independent third-party sites and certain official documents on company website archive: no breach of Clause 22 and no breach of Clause 2 (upheld on appeal)
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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A member of the public complained about promotion of Rectogesic (glyceryl trinitrate (GTN) rectal ointment) by ProStrakan, including alleged breaches of an undertaking given in Case AUTH/1892/9/06.
The complainant found historic ProStrakan press releases and an annual report on multiple independent internet sites containing the previously-ruled misleading statement: “Rectogesic works by relaxing the vascular smooth muscle around the anal canal… aiding the healing of the fissure”.
The complainant also found the same statement within ProStrakan’s own website archive (financial results/annual report documents), and argued it should have been removed or corrected.
Separately, the complainant found a sponsored “Advertisement Feature”/Quick Guide (“Management of chronic anal fissure”) on the online Pulse site, developed for The Practitioner but appearing online, with ProStrakan sponsorship/logo and a Rectogesic advertisement.
The Quick Guide’s treatment algorithm recommended topical GTN 4mg/g (ie Rectogesic) for 6–8 weeks and suggested a further 6–8 week course in certain patients, including those “unhealed and asymptomatic”.
The Quick Guide/feature did not include prescribing information for Rectogesic.

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Press releases/annual report on independent sites and ProStrakan’s website archive: No breach of Clause 22 and no breach of Clause 2 were ruled; these no-breach rulings were appealed by the complainant and upheld by the Appeal Board.
Quick Guide “Advertisement Feature”: The Panel ruled the material was promotional and ProStrakan was responsible for its content (including what its agents did on its behalf), despite online publication being “unbeknown to” the company.
Breach of Clause 4.1 (no prescribing information) was ruled and accepted by ProStrakan.
Two breaches of Clause 3.2 were ruled for recommendations inconsistent with the SPC (repeat course beyond max 8 weeks; and use in asymptomatic/unpainful patients implying use for healing).
Breach of Clause 22 was ruled because the algorithm effectively promoted use for healing/no pain and was caught by the prior undertaking.
Breach of Clause 2 was ruled because failure to stop publication after signing the undertaking brought discredit upon and reduced confidence in the industry.

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