Sanofi-Aventis: Plavix promotion misleadingly linked REACH registry to Plavix use (AUTH/2146/7/08)

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Key facts

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Case number	AUTH/2146/7/08
Case reference	Code of Practice Review November 2008, Case AUTH/2146/7/08
Complainant	Primary care trust chief pharmacist
Respondent/company	Sanofi-Aventis
Product(s)	Plavix (clopidogrel)
Material/channel	Leavepiece and reply paid card (PLA07/1081); detail aid used in GP practice meeting (PLA07/1601)
Key issue	Misleading linkage implying the REACH registry supported the use of Plavix per se; representative presentation and briefing materials contributed to misleading impression
Dates (received/completed if stated)	Complaint received 23 July 2008; case completed 1 October 2008
Appeal	Not stated
Code year	2008 Code (clauses cited were the same as the 2006 Code)
Breaches/clauses	7.2, 15.2, 15.9
Sanctions	Not stated

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

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The chief pharmacist at a primary care trust complained about the promotion of Plavix (clopidogrel) by Sanofi-Aventis and the conduct of its representative.
Materials at issue were a leavepiece and a reply paid card (both referenced PLA07/1081); the representative also used a primary care detail aid (PLA07/1601) in a practice meeting.
The complainant alleged the representative left the leavepiece with a GP practice and verbally linked the REACH registry study to a lifelong need for Plavix, implying REACH supported choosing Plavix over other antiplatelets.
The Panel reviewed the structure/content of the detail aid: REACH registry pages were presented between Plavix/aspirin messaging and CAPRIE trial data, with a design element (red line with Plavix logo) that could visually link REACH content to Plavix.
The Panel noted the representative’s briefing document included the key message: “REACH supports the use of Plavix within the current strategy in the management of the multi-vascular patient with established atherothrombosis”.
The Panel considered that, on the balance of probabilities, meeting attendees would be left with the impression that REACH supported the use of Plavix per se, reinforced by distribution of a REACH leavepiece that included Plavix prescribing information.

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The Panel ruled it was misleading to link REACH registry data to the use of Plavix in particular.
Breaches were ruled for misleading association of REACH with Plavix and for failures relating to representative conduct/requirements.
Complaint received: 23 July 2008.
Case completed: 1 October 2008.

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Clause 7.2 (breach ruled): misleading to link REACH registry data to the use of Plavix in particular.
Clause 15.2 (breach ruled): representative, by following briefing material and using the detail aid/leavepiece, structured a presentation that gave a misleading impression; relevant Code requirements not complied with.
Clause 15.9 (breach ruled): briefing document key message (“REACH supports the use of Plavix…”) was misleading because it directly associated REACH with Plavix; REACH established need for treatment generally while CAPRIE supported Plavix specifically.

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