AUTH/2153/8/08: Actonel leavepiece and use of draft NICE recommendations (Procter & Gamble)

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Key facts

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Case number	AUTH/2153/8/08
Case reference	Actonel leavepiece (ref ACT3987)
Complainant	Prescribing support pharmacist
Respondent/company	Procter & Gamble Pharmaceuticals UK, Limited
Product(s)	Actonel (risedronate); Didronel PMO (etidronate)
Material/channel	Leavepiece (promotional material)
Key issue	Misleading presentation of NICE information (draft vs final context), unbalanced claim implying preference for risedronate, and an out-of-context/inaccurate NICE quotation under “Should patients be switched?”
Dates (received/completed if stated)	Complaint received 5 August 2008; Case completed 15 September 2008
Appeal	Not stated
Code year	2008
Breaches/clauses	Clause 7.2; Clause 10.2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A prescribing support pharmacist complained about an Actonel (risedronate) leavepiece (ref ACT3987) issued by Procter & Gamble Pharmaceuticals UK, Limited.
Procter & Gamble also marketed Didronel PMO (etidronate); both products were for use in the treatment or prevention of postmenopausal osteoporosis.
The leavepiece was titled “Latest NICE information included (July 2008) for Primary and Secondary Prevention of Osteoporotic Fragility Fractures in Postmenopausal Women” and referenced NICE final appraisal determinations (July 2008).
The complainant telephoned NICE and was told the guidelines were still in draft form and had not been finalised.
The complainant alleged: (1) a quotation implied risedronate was recommended above etidronate; (2) a quotation under “Should patients be switched?” was taken out of context; and (3) the complainant could not find the quotation in the draft document.
The Authority asked Procter & Gamble to respond in relation to Clauses 7.2 and 10.2 of the 2008 Code.

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The Panel ruled the leavepiece title was misleading because readers would be unaware at the outset that the information came from recommendations not yet finalised; breach of Clause 7.2.
The Panel ruled the claim “Risedronate is recommended as the first alternative treatment option alongside etidronate” was not a fair and balanced reflection of the NICE document and was misleading; breach of Clause 7.2.
The Panel ruled the quotation presented under the heading “Should patients be switched?” was not in its correct context and was misleading; breach of Clause 7.2.
The Panel ruled the quotation as presented was not an accurate quotation and did not reflect the meaning of the relevant sections of the NICE final appraisal document; breach of Clause 10.2.

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Clause 7.2 (misleading claims / accuracy and balance): breached in relation to the leavepiece title, the risedronate/etidronate claim, and the “Should patients be switched?” presentation.
Clause 10.2 (quotations): breached because the NICE quotation as used was not accurate and did not reflect the meaning of the source.

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