Teva UK misleading superiority claim for Qvar leavepiece: “Twice as many symptom-free days” (AUTH/2007/5/07)

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Key facts

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Case number	AUTH/2007/5/07
Complainant	Trinity-Chiesi Pharmaceuticals Ltd
Respondent	Teva UK Limited
Product	Qvar (CFC-free beclometasone dipropionate inhaler)
Material	Leavepiece (refs IV/QV/CNL/12/06A and IV/QV/CFC/01/07)
Main claim at issue	“Twice as many symptom-free days” (vs CFC beclometasone (BDP))
Key references cited	Price et al (2002) based on Fireman et al (2001)
Complaint received	31 May 2007
Case completed	9 January 2008
Applicable Code year	2006
Breach clauses	Clause 7.2
Appeal	Yes (by respondent); unsuccessful
Sanctions	Undertaking received; additional sanctions not stated

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

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Trinity-Chiesi complained about a Teva UK promotional leavepiece for Qvar (a CFC-free beclometasone dipropionate inhaler for asthma).
The leavepiece (refs IV/QV/CNL/12/06A and IV/QV/CFC/01/07) carried the claim: “Twice as many symptom-free days” (vs CFC beclometasone (BDP)).
The claim was referenced to Price et al (2002), a pharmacoeconomic analysis based on clinical data from Fireman et al (2001).
Trinity-Chiesi alleged the claim was not a fair and balanced representation of the evidence, arguing Teva highlighted one dataset/analysis and did not reflect other relevant published evidence and context (including that Fireman et al found asthma control was maintained and noted some statistically significant differences were “probably not clinically significant”).
Teva denied breach, arguing Price et al used appropriate non-parametric methods and that symptom-free days (a composite endpoint) was distinct from individual symptom reporting; Teva also argued other cited studies were not comparable.
The Panel considered the robustness of the evidence base underpinning the strength of the “twice as many” claim; Teva appealed and the Appeal Board reviewed the same core issue.

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Breach found: the claim “Twice as many symptom-free days” was ruled misleading.
The Panel ruled a breach of Clause 7.2.
Teva appealed; the appeal was unsuccessful and the breach finding was upheld.

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