AstraZeneca: COPD budget impact report implied consultant authorship/endorsement (Symbicort) (AUTH/2265/9/09)

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Key facts

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Case number	AUTH/2265/9/09
Company	AstraZeneca UK Limited
Complainant	Consultant respiratory physician
Product	Symbicort (formoterol and budesonide)
Therapy area	Chronic obstructive pulmonary disease (COPD)
Material	Symbicort Budget Impact Model (BIM) summary report: “Effective Treatment of Chronic Obstructive Pulmonary Disease. The NHS challenge” (20 pages; prescribing information on final four pages)
Main issue	Front page implied consultant authorship/endorsement; dissemination without informed consent; procedures not followed
Complaint received	10 September 2009
Case completed	17 November 2009
Applicable Code year	2008
Breach clauses	7.2, 9.1 (x2), 9.3
No breach clauses considered	10.2, 10.3, 10.4
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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A consultant respiratory physician complained about promotion of Symbicort (formoterol/budesonide) for COPD by a former AstraZeneca representative.
A 20-page document titled “Effective Treatment of Chronic Obstructive Pulmonary Disease. The NHS challenge” displayed the consultant’s name/job title/hospital on the front page next to the AstraZeneca corporate logo.
The document was generated from the Symbicort Budget Impact Model (BIM), a spreadsheet tool used to produce health-economic outputs and a printable summary report.
The layout gave the impression the consultant had written or endorsed the document; there was no clear statement of authorship (AstraZeneca/representative) or that it was for the recipient’s information only.
The document was forwarded electronically and discussed within local NHS decision-making settings (formulary group and primary care committees) without the consultant’s informed consent.
Contrary to company policy, there was no evidence the representative explained the BIM tool, that the consultant requested a hard copy report, or that she consented to dissemination.
Head office permission for electronic dissemination was granted, but without checking that prior written permission from the recipient had been obtained.

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Breach of Clause 7.2 (misleading) was ruled.
Breach of Clause 9.3 (promotion must not be such as to bring discredit/contrary to professional conventions; implied endorsement) was ruled.
Breach of Clause 9.1 was ruled (high standards not maintained) in relation to the approved format/material design.
A further breach of Clause 9.1 was ruled regarding the representative’s role and failure to follow company procedures in creation/dissemination.
No breach of Clauses 10.2, 10.3 and 10.4 was ruled (document was not a reprint and did not quote the complainant).
No appeal.

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