AUTH/2457/11/11: General Practitioner v Teva — Qvar BMJ ad challenged on missing statistical detail (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2457/11/11
Parties	General Practitioner v Teva UK Limited
Product	Qvar (CFC-free beclometasone dipropionate)
Indication (as stated)	Prophylactic management of mild, moderate or severe asthma
Material	Advertisement in the BMJ (10 September 2011), Ref QV/11/003d
Main issues	Alleged misleading omission of confidence intervals/p values for a comparative claim; request for AE reporting contact details
Reference cited	McKnight et al poster, European Respiratory Society congress, 2010
Complaint received	17 November 2011
Case completed	9 January 2012
Applicable Code year	2011
Clauses considered	4.10, 7.2, 7.3
Outcome	No breach of the Code
Appeal	No appeal

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

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A general practitioner (and ex-employee of Cephalon (UK) Ltd) complained about a Teva UK Limited advertisement for Qvar (CFC-free beclometasone dipropionate) published in the BMJ on 10 September 2011 (Ref QV/11/003d).
The ad included a comparative claim: “Qvar Easi-Breathe has real-life data from real-life patients. It shows significantly more patients using Qvar Easi-Breathe had their asthma controlled than patients using Clenil Modulite pMDI* …”
The footnote stated: “Pressurised Metered Dose Inhaler. Percentage controlled on Qvar Easi-Breathe 64% (0.64). Percentage controlled on Clenil Modulite = 54%. Therefore ARR is 0.64 – 0.54 = 0.1. Numbers needed to treat = 10”.
The claim was referenced to a poster by McKnight et al presented at the European Respiratory Society congress, 2010.
The complainant alleged the ad omitted confidence intervals and p values, making the statistical information insufficient for prescribing decisions and potentially misleading (Clauses 7.2 and 7.3).
The complainant also said it would have been helpful to include a telephone number/email address for adverse event reporting or further information (Clause 4.10 supplementary information).

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