AstraZeneca: paid-for Pharmaceutical Journal statins insert ruled disguised promotion for Crestor (AUTH/1951-1955/2/07)

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Key facts

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Case numbers	AUTH/1951/2/07; AUTH/1952/2/07; AUTH/1953/2/07; AUTH/1954/2/07; AUTH/1955/2/07
Company	AstraZeneca UK Limited
Complainants	Pharmacists (letters published in The Pharmaceutical Journal; taken up by the Director as complaints)
Material	12-page insert/supplement distributed with The Pharmaceutical Journal (20 Jan 2007), titled “The new NICE guidance on the use of statins in practice – Considerations for implementation”
Product	Rosuvastatin (Crestor)
Main issues	Disguised promotion; missing prescribing information; misleading implications about licensed indication; not up-to-date with national policy statement; encouragement of non-national JBS-2 targets; omission of specialist supervision/routine follow-up for rosuvastatin 40mg; misleading economic presentation
Applicable Code year	2006
Complaint received	05 February 2007
Case completed	03 July 2007
Appeal	Respondent appealed; Appeal Board upheld Panel’s rulings
Sanctions	Undertaking received; Additional sanctions; Advertisement

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

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Five letters in The Pharmaceutical Journal (3 Feb 2007) criticised a 12-page insert distributed with the journal (20 Jan 2007) titled “The new NICE guidance on the use of statins in practice – Considerations for implementation”.
The insert was financially supported by AstraZeneca and written by a GP and a pharmacist; it discussed NICE statin guidance, lipid targets, optimisation strategies, and included a cost-effectiveness/budget impact model comparing atorvastatin vs rosuvastatin (Crestor) after simvastatin.
Complainants alleged the piece was effectively a promotional brochure/advertorial for Crestor, encouraged non-national JBS-2 lipid targets (4 and 2 mmol/L), implied outcome benefits not supported by Crestor’s licence, and omitted key safety/usage restrictions for rosuvastatin 40mg and prescribing information.
The Director took the letters up as complaints under the Code (AUTH/1951/2/07 to AUTH/1955/2/07).
AstraZeneca argued it was an independently written educational discussion; authors had editorial control; AstraZeneca reviewed for factual accuracy and Code compliance; sponsorship was declared as “Supported by AstraZeneca”.
The Panel and (on appeal) the Appeal Board found AstraZeneca initiated, funded, supplied data, reviewed, and took the final decision to publish—so the arrangement was not arm’s length and the insert was, in effect, promotional for Crestor.

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Breaches were ruled in all five cases for high standards and disguised promotion (Clause 9.1 and Clause 10.1).
In cases where prescribing information was alleged missing (AUTH/1953/2/07, AUTH/1954/2/07, AUTH/1955/2/07), the Panel/Appeal Board ruled the insert should have included Crestor prescribing information (Clause 4.1 breach).
Misleading implications about Crestor’s licensed indication and encouragement of non-national targets led to breaches of Clauses 7.2 and 7.4 in AUTH/1951/2/07 and AUTH/1952/2/07.
Failure to be up-to-date (omitting important national statement on targets) led to Clause 7.2 breaches in AUTH/1951/2/07 and AUTH/1953/2/07.
Rosuvastatin 40mg safety/specialist supervision omissions and dismissal of differential safety concerns led to Clause 7.2 and 7.10 breaches in AUTH/1953/2/07.
Clause 2 (bringing discredit/reducing confidence) was breached in AUTH/1951/2/07, AUTH/1952/2/07 and AUTH/1953/2/07 (but not ruled in AUTH/1954/2/07 or AUTH/1955/2/07 on the basis of the allegations made).
No breach was ruled for sponsorship identification (Clause 9.10) because “Supported by AstraZeneca” was clearly stated on the front cover.
No breach was ruled for “masquerading as NICE guidance” (no breach of Clause 7.2 on that specific point) because the title made clear it was about implementation considerations.
AstraZeneca appealed all rulings; the Appeal Board upheld the Panel’s rulings.

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