Sanofi-Aventis: Plavix promotion—misleading linkage of REACH registry to Plavix use

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Key facts

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Case number	AUTH/2146/7/08
Case reference	Not stated
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 of REACH registry data to Plavix use (implying REACH supported Plavix per se) and representative conduct/briefing leading to that impression
Dates (received/completed if stated)	Complaint received 23 July 2008; Case completed 1 October 2008
Appeal	Not stated
Code year	2008 Code
Breaches/clauses	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 Plavix primary care detail aid (PLA07/1601) in a practice meeting.
The complainant alleged the representative verbally linked the REACH registry study with a lifelong need for Plavix and that REACH gave no grounds for choosing one antiplatelet over another.
The Panel reviewed the structure/content of the detail aid: REACH registry pages were presented between Plavix claims and CAPRIE data, with a design element (a red line incorporating the Plavix logo) that could visually link REACH to Plavix.
The Panel noted the representative’s presentation (as described by the company) introduced Plavix in atherothrombosis, discussed REACH, then CAPRIE, and concluded by returning to REACH data and stating patients with disease in two or three locations would be ideal targets for Plavix; attendees received a REACH leavepiece including Plavix prescribing information.
The Panel considered the representatives’ briefing document stated as a key message that “REACH supports the use of Plavix…” which the Panel viewed as directly associating REACH with Plavix.

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The Panel ruled it was misleading to link the REACH registry data to the use of Plavix in particular and that, on the balance of probabilities, attendees would be left with the impression that REACH supported the use of Plavix per se.
The Panel ruled that although the representative followed company briefing/materials, the Code requirements had not been complied with.
Breaches were ruled of Clauses 7.2, 15.2 and 15.9.

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Clause 7.2 – Breach ruled (misleading to link REACH registry data to the use of Plavix in particular; impression that REACH supported Plavix per se).
Clause 15.2 – Breach ruled (representative’s presentation, following briefing/materials, 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; mixed REACH and CAPRIE messages and advocated a course of action likely to lead to a breach).

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