Sanofi-Aventis: Acomplia leavepiece found misleading in its summary of NICE guidance and HbA1c messaging (AUTH/2157/8/08)

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Key facts

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Case number	AUTH/2157/8/08
Case reference	AUTH/2157/8/08 PRACTICE PHARMACIST v SANOFI-AVENTIS
Complainant	Practice pharmacist
Respondent/company	Sanofi-Aventis
Product(s)	Acomplia (rimonabant)
Material/channel	Four-page leavepiece (“Nice news for Norman”) left by a company representative
Key issue	Misleading summary/paraphrase of NICE guidance (including omission of third-line restriction and altered emphasis on treatment beyond 2 years) and misleading presentation of HbA1c benefit not sufficiently contextualised within weight loss indication
Dates (received/completed if stated)	Complaint received 6 August 2008; Case completed 22 September 2008
Appeal	Not stated
Code year	2008 (Clause 7.2 noted as same in 2006 and 2008; case considered under 2008 Constitution and Procedure)
Breaches/clauses	Clause 7.2
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 practice pharmacist complained about a four-page leavepiece, “Nice news for Norman”, promoting Acomplia (rimonabant), left by a Sanofi-Aventis representative.
The complainant alleged the front and back covers implied Acomplia was the NICE-recommended treatment for overweight type 2 diabetics, while the inside text referenced use when patients could not take orlistat or sibutramine.
The complainant alleged the leavepiece misstated NICE guidance on continuing treatment beyond 2 years by saying patients should continue beyond 2 years only after clinical review.
The complainant alleged the leavepiece implied Acomplia’s virtues as an antidiabetic medicine by stating it would reduce HbA1c.
Sanofi-Aventis said the leavepiece was intended to inform health professionals following NICE approval on 25 June 2008 and that the claims were an accurate introductory summary of NICE guidance and consistent with the SPC.

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The Panel ruled the front/back cover claim summarising NICE guidance was misleading because it implied NICE had approved Acomplia for any type 2 diabetic with BMI >27kg/m², omitting the NICE restriction relating to inadequate response/intolerance/contraindication to orlistat and sibutramine.
The Panel ruled the statement about continuing beyond 2 years was not an accurate reflection of NICE guidance because the change in wording altered meaning and emphasis.
The Panel ruled the HbA1c/glycaemic control messaging was misleading because glycaemic control was not placed sufficiently within the context of weight loss (the licensed indication).

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Clause 7.2 (misleading claims / accuracy, including reporting third-party guidance): Breach ruled in relation to (1) misleading summary of NICE guidance on the front/back cover, (2) inaccurate reflection of NICE wording on treatment beyond 2 years, and (3) insufficient contextualisation of HbA1c benefit within the licensed indication.

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