AUTH/2010/6/07: GP v Sanofi-Aventis — Acomplia ‘50% beyond weight loss’ cardiometabolic risk factor claim (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2010/6/07
Complainant	General practitioner
Company	Sanofi-Aventis
Medicine	Acomplia (rimonabant)
Issue	Substantiation/accuracy of claim that “An estimated 50%” of effects on cardiometabolic risk factors were beyond those expected from weight loss alone
Trigger for complaint	Drug and Therapeutics Bulletin review (June 2007) questioning whether benefits beyond weight loss were attributable to the medicine
Applicable Code year	2006
Clauses considered	7.2 and 7.4
Panel decision	No breach
Complaint received	11 June 2007
Case completed	2 August 2007
Appeal	No appeal
Sanctions	None

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

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A general practitioner complained about Sanofi-Aventis’ promotion of Acomplia (rimonabant), focusing on the claim: “An estimated 50% of the effects of Acomplia on Cardiometabolic Risk Factors are beyond those expected from weight loss alone”.
The complainant cited a June 2007 Drug and Therapeutics Bulletin review suggesting any additional benefits beyond weight loss “might not be due to the medicine itself”, and asked the Panel to reconsider the claim.
The matter was treated as a new complaint under Paragraph 5.1 of the Constitution and Procedure.
The Authority asked Sanofi-Aventis to respond in relation to Clauses 7.2 and 7.4.
Sanofi-Aventis argued the claim was based on the Acomplia SPC and supported by several randomised controlled trials; the Bulletin article was opinion/review and presented no new data refuting the claim.

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No breach of the Code was ruled.
The Panel found the claim was consistent with the SPC and, with the wording “estimated”, was a fair reflection of the known data and could be substantiated.
No breach of Clauses 7.2 and 7.4 was ruled.

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