AstraZeneca breached ABPI Code over misleading Casodex 150 claim; inadequate Code briefing upheld (AUTH/1950/1/07)

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Key facts

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Case	AUTH/1950/1/07
Company	AstraZeneca
Complainant	Ex-employee
Product	Casodex 150 (bicalutamide)
Main issues	Misleading efficacy claim vs castration; call metrics/pressure; inadequate advice/briefing on staying within the Code; Clause 2 alleged
Applicable Code year	2006
Complaint received	22 January 2007
Case completed	14 June 2007
Breach clauses	Clause 7.2 and 15.9
No breach findings	Clause 7.2 (revised claim “No different to castration in overall survival”); Clause 9.1; Clause 2 (upheld on appeal)
Sanctions	Undertaking received; additional sanctions not stated

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

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A former AstraZeneca employee complained about promotion of Casodex 150 (bicalutamide), including claims of efficacy vs castration, representative call metrics, and lack of advice on staying within the Code.
From Jan 2004 to Feb 2006, promotional materials used the claim “Equivalent efficacy to castration”, despite the SPC stating that “equivalence … could not be concluded statistically”.
After the complainant raised a formal grievance, AstraZeneca recalled materials (17 Feb 2006) and changed the claim to “No different to castration in overall survival”.
The complainant alleged pressure and threats linked to call frequency targets (eg 12 face-to-face calls), including use of short-term performance measures.
The complainant alleged a “fear culture” and that concerns raised via multiple management routes did not receive advice on staying within the Code.
Clause 2 (bringing discredit) was alleged based on cumulative issues and prior related cases.

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Breach found: the claim “Equivalent efficacy to castration” was misleading (breach of Clause 7.2).
No breach: the revised claim “No different to castration in overall survival” was not ruled misleading (no breach of Clause 7.2); this was upheld on appeal.
No breach: insufficient evidence that placing representatives on short-term objectives for failing to meet frequency targets breached the Code (no breach of Clause 9.1).
Breach found: AstraZeneca’s briefing material/advice on staying within the Code was inadequate (breach of Clause 15.9).
No breach: Clause 2 was not breached; this was upheld on appeal.

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