Pfizer: Lipitor journal ad—economic modelling percentages presented as clinical absolutes (AUTH/2184/11/08)

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Key facts

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Case number	AUTH/2184/11/08
Company	Pfizer Limited
Product	Lipitor (atorvastatin)
Material	Journal advertisement (ref LIP3055c) in Guidelines in Practice, volume II, 7 July
Complainant	Primary Care Trust head of medicines management and a GP medical advisor/general practitioner
Complaint received	14 November 2008
Case completed	8 January 2009
Applicable Code year	2008
Breach clauses	7.2, 7.3, 7.4
Key issue	Economic modelling “37% vs 82% achieve target” presented in a way that implied proven clinical outcomes; not capable of substantiation in context
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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A Primary Care Trust head of medicines management and a GP medical advisor/GP complained about a Pfizer journal advertisement for Lipitor (atorvastatin) (ref LIP3055c) placed in Guidelines in Practice.
The ad referenced newly published NICE lipid modification & type 2 diabetes guidance and included a prominent cholesterol target message for patients with established CVD or type 2 diabetes.
The ad then made comparative statements based on “economic modelling estimates”, including that only 37% of patients would achieve total cholesterol <4mmol/L with simvastatin 40mg, versus 82% with a “simvastatin 40mg – Lipitor titration strategy”, referenced to “data on file”.
Complainants alleged: (1) the NICE target message could be read as applying to all patients; (2) the 37%/82% claims were not robust (unpublished, not peer reviewed, modelling rather than real patient outcomes); and (3) the ad implied NICE endorsement of Lipitor.

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Breach found for the economic modelling percentage claims: the Panel considered they were presented as proven clinical outcomes and were not capable of substantiation in context.
No breach for the allegation that the NICE target message applied to all patients (Panel considered the subset population was clear).
No breach for the allegation that the ad implied NICE endorsed Lipitor.

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