AUTH/2572/1/13: Ex-employee v AstraZeneca – archived investor presentations and Seroquel weight-gain claims (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2572/1/13
Company	AstraZeneca
Complainant	Ex-employee
Medicine	Seroquel (quetiapine)
Material	Five investor presentations in archived website section (dated 1999, 2001, 2002, 2004, 2006)
Main issue	Whether weight-related statements were a fair and balanced reflection of evidence available at the time
Claims noted by Appeal Board	“Seroquel - minimal weight gain” (1999); “weight neutral in the long term” (2001); “Weight-neutral long-term” / “weight-neutral in the long term” (2002); “Favourable weight profile long-term” (2004); “Less weight gain than with olanzapine” (2006)
Applicable Code year	2012
Clause(s) considered	Clause 7.2
Panel decision	No breach of Clause 7.2
Appeal	Appeal by complainant; unsuccessful
Appeal Board decision	Upheld no breach of Clause 7.2
Complaint received	15 January 2013
Case completed	26 June 2013

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

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An ex-employee complained about AstraZeneca’s promotion of Seroquel (quetiapine), focusing on five presentations (dated 1999, 2001, 2002, 2004 and 2006) hosted in the archived “material for investors” section of AstraZeneca’s website.
The presentations had previously been considered in an alleged breach of undertaking matter (Case AUTH/2538/10/12). The complainant brought this as a separate content complaint (not an undertaking breach).
The complainant alleged the presentations showed AstraZeneca “spread false claims” about Seroquel’s effect on body weight and challenged AstraZeneca’s earlier statement that the claims “evolved as a balanced and fair reflection of the evidence available at the time”.
Support cited included a CBS news item and multiple blog posts/links by a retired US psychiatrist, including discussion of internal documents disclosed in US litigation.
The case proceeded as an alleged breach of Clause 7.2 (2012 Code) and was appealed by the complainant after the Panel ruled no breach.

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No breach of the Code was ruled by the Panel: no breach of Clause 7.2.
The complainant appealed; the Appeal Board upheld the Panel’s ruling of no breach of Clause 7.2. The appeal was unsuccessful.
The Panel noted concern that AstraZeneca had not provided a substantive response to the Clause 7.2 allegation, but decided (given the exceptional background) not to report AstraZeneca to the Appeal Board under Paragraph 8 for consideration of further sanctions.

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