AUTH/1923/12/06 & AUTH/1924/12/06: Bristol-Myers Squibb and Sanofi-Aventis – Aprovel/CoAprovel mailing implied CV risk reduction | PMCPA Case

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Key facts

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Case numbers	AUTH/1923/12/06 and AUTH/1924/12/06
Complainant	Pharmacist practitioner at a general practice
Companies	Bristol-Myers Squibb Pharmaceuticals Ltd and Sanofi-Aventis
Product(s)	Aprovel (irbesartan) and CoAprovel (irbesartan and hydrochlorothiazide)
Material	GP promotional mailing (ref APR 06/2319)
Main issue	Implied cardiovascular risk reduction claims without product-specific evidence; misleading presentation due to layout/context
Key claims challenged	“Treat BP to target today…reduce CV risk tomorrow”; “Aprovel’s power to lower blood pressure can help reduce cardiovascular risk in patients with additional risk factors”
Applicable Code year	2006
Breach clauses	Two breaches of Clause 7.2 and two breaches of Clause 7.4
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	4 December 2006
Case completed	12 February 2007
Appeal	No appeal
Published	May 2007 Code of Practice Review

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

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A pharmacist practitioner complained about a short GP promotional mailing for Aprovel (irbesartan) and CoAprovel (irbesartan/hydrochlorothiazide), co-promoted by Bristol-Myers Squibb and Sanofi-Aventis.
The mailing featured the bold heading: “Treat BP to target today…reduce CV risk tomorrow”, positioned near the product logos.
It also included the unreferenced claim: “Aprovel’s power to lower blood pressure can help reduce cardiovascular risk in patients with additional risk factors”.
The complainant argued there was no robust evidence that Aprovel or CoAprovel reduced cardiovascular risk, and queried whether the claim relied on post-hoc/observational analyses.
The companies responded jointly that the statements reflected general guideline-based principles (BP lowering reduces CV risk) and were not intended as product-specific outcome claims.
The Panel considered the overall layout meant readers would assume the BP/CV risk statements were linked to Aprovel/CoAprovel, with no clear separation between general statements and product claims.

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The Panel ruled the claims implied Aprovel/CoAprovel reduced cardiovascular risk, but there was no product-specific data to support that.
The claims were found misleading and not capable of substantiation.
Breach found: two breaches of Clause 7.2 and two breaches of Clause 7.4.
No appeal.

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