Sanofi-Aventis Acomplia (rimonabant) GP ad: cardiometabolic risk messaging ruled misleading

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Key facts

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Case	AUTH/1871/7/06
Parties	Doctor v Sanofi-Aventis
Material	Acomplia (rimonabant) journal advertisement in GP (ref RIM06/335)
Complaint received	27 July 2006
Case completed	7 November 2006
Applicable Code year	2006
Breach clauses	Clause 3.2; Clause 7.2; Clause 7.4
No breach clauses	Clause 2; Clause 9.1
Key issue	Overall impression suggested prescribing for broad cardiometabolic risk-factor effects in “overweight” patients; “50% beyond weight loss” claim read as applying to all listed risk factors
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeals	Sanofi-Aventis appeal (against breaches) unsuccessful; complainant appeal (seeking Clause 2 and 9.1 breaches) unsuccessful

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

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A doctor complained about a Sanofi-Aventis advertisement for Acomplia (rimonabant) published in GP.
The ad headline stated: “Cardiometabolic risk factors in overweight patients can be where you least expect them”, alongside a silhouette graphic and the strapline “It’s not what you lose. It’s what you gain”.
The ad listed “established” and “emerging” cardiometabolic risk factors, then presented Acomplia data on weight/waist reduction and improvements in HbA1c, HDL-c and triglycerides.
The ad included the claim: “An estimated 50% of the effects of Acomplia on Cardiometabolic Risk Factors are beyond those expected from weight loss alone”.
The complainant alleged the ad implied Acomplia could be used to treat all cardiometabolic risk factors and encouraged use beyond the licensed indication.
Sanofi-Aventis argued the ad provided context/education and that the “50% beyond weight loss” statement was supported by the SPC for HbA1c, HDL-c and triglycerides.

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Breach found: the ad did not place cardiometabolic risk factors sufficiently in the context of the licensed indication and gave the overall impression Acomplia should be prescribed for effects on cardiometabolic risk factors in overweight patients (inconsistent with the SPC).
Breach found: the “50% beyond weight loss” claim appeared to apply to all listed cardiometabolic risk factors (not just HbA1c, HDL-c and triglycerides), making it misleading and not capable of substantiation.
No breach of Clause 9.1 (high standards) and no breach of Clause 2 (particular censure).
Sanofi-Aventis’ appeal against breaches was unsuccessful; the complainant’s appeal seeking Clause 2 and 9.1 breaches was also unsuccessful.

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