AUTH/1976/3/07: GP complaint about Acomplia ad and alleged breach of undertaking (No breach)

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Key facts

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Case number	AUTH/1976/3/07
Complainant	General practitioner (and Director for alleged breach of undertaking element)
Company	Sanofi-Aventis
Product	Acomplia (rimonabant)
Material	Journal advertisement in Update, March 2007 (ref ACO 07/1049)
Main issue	Whether the ad misleadingly implied weight-independent effects and encouraged prescribing beyond the obesity indication; and whether it breached a prior undertaking
Key claim challenged	“An estimated 50% of the effects of Acomplia on these Cardiometabolic Risk Factors are beyond those expected from weight loss alone”
Applicable Code year	2006
Clauses considered	2, 7.2, 7.4, 9.1, 22
Panel decision	No breach
Complaint received	15 March 2007
Case completed	21 May 2007
Appeal	No appeal
Related prior case	AUTH/1871/7/06 (earlier Acomplia ad; breaches upheld on appeal)

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

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A general practitioner complained about a Sanofi-Aventis journal advertisement for Acomplia (rimonabant) published in Update (March 2007) (ref ACO 07/1049).
The ad highlighted three cardiometabolic risk factors (HbA1c, HDL-C and triglycerides) and included the claim: “An estimated 50% of the effects of Acomplia on these Cardiometabolic Risk Factors are beyond those expected from weight loss alone”.
The GP alleged the ad suggested a direct (weight-independent) effect and invited prescribing outside the licensed indication (ie for the primary/sole purpose of improving HbA1c, HDL-C and triglycerides).
The GP also alleged the ad implied these were the only relevant cardiometabolic markers and was misleading by omitting that the SPC stated Acomplia 20mg generally had no significant effect on Total-C or LDL-C.
Because the complaint involved an alleged breach of an undertaking from a previous case (AUTH/1871/7/06), the Director took up that element to ensure compliance with undertakings.
Sanofi-Aventis argued the ad had been amended versus the earlier version to make clear the “50% beyond weight loss” statement applied to the three listed risk factors and that the overall message was anchored to obesity and the licensed indication.

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No breach of the Code was ruled.
The Panel found the ad was materially different from the earlier ad considered in AUTH/1871/7/06 and was not caught by the prior undertaking.
The Panel did not accept that the ad invited prescribing for the primary and sole purpose of addressing HbA1c, HDL-C and triglycerides.
The Panel did not consider it misleading that the ad did not mention Total-C/LDL-C or the SPC statement that Acomplia 20mg generally had no significant effect on Total-C or LDL-C.

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