ProStrakan press coverage of Rectogesic and SMC rejection: no breach (AUTH/1826/4/06)

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Key facts

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Case number	AUTH/1826/4/06
Complainant	Member of the public
Company	ProStrakan Group plc
Product	Rectogesic (glyceryl trinitrate (GTN) rectal ointment)
Media/channel	The Herald (newspaper in Scotland)
Issue	Attributed statements about indication (“treatment of anal fissures”), comparisons with surgery (“costs much less”), “only alternative to surgical treatment”, and omission of common side effect (headache)
Applicable Code	2003
Clauses cited	3.2, 7.2, 7.3, 7.4, 20.2
PMCPA outcome	No breach
Complaint received	17 April 2006
Case completed	19 May 2006
Appeal	No appeal

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

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A member of the public complained about an article in The Herald reporting ProStrakan’s reaction to the Scottish Medicines Consortium (SMC) rejection of Rectogesic (glyceryl trinitrate (GTN) rectal ointment).
The article attributed statements to ProStrakan including that Rectogesic was “an ointment for the treatment of anal fissures”, that it “costs much less than surgery”, and that it was “currently the only alternative to surgical treatment”.
The complainant argued Rectogesic was licensed only for relief of pain associated with chronic anal fissure (not healing, not acute fissures), and that comparisons with surgery and “only alternative” claims were misleading and unsubstantiated.
The complainant also alleged the article was not fair/balanced for public information about a POM and omitted the most common side effect (headache), implying it was a safe alternative to surgery.
ProStrakan said the journalist used multiple sources; only quoted text was attributable to the spokesperson; other wording was the journalist’s paraphrase. ProStrakan provided the SMC press statement, SPC and Prodigy (NHS) information, and explained its SMC submission context.

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No breach of the Code (2003 Code).
The Panel assessed complaints about press articles by reference to information supplied by the company to the press, not the article content itself.
Where statements were not in quotation marks (but attributed to ProStrakan), the Panel considered the article misleading but did not hold ProStrakan responsible in the absence of evidence of what was actually said.
The quoted statement “costs much less than surgery” was not considered to imply Rectogesic was licensed as an alternative to surgery and was not found to breach the Code.
Omission of the most common side effect in the article was not considered to create a misleading impression that Rectogesic was an entirely safe alternative to surgery.

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