Teva UK Ltd: Guidelines in Practice insert on switching to CFC-free beclometasone inhalers (Qvar) found misleading and promotional

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Key facts

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Case number	AUTH/2060/10/07
Case reference	General Practitioner v Teva
Complainant	General practitioner
Respondent/company	Teva UK Ltd
Product(s)	Qvar; Clenil Modulite
Material/channel	Insert/supplement distributed with Guidelines in Practice (September 2007); also supplied to Teva field force for use in calls
Key issue	Whether the insert was effectively promotional and whether claims were misleading due to omission/imbalance and incorrect referencing; prohibited reference to MHRA in promotional material
Dates (received/completed if stated)	Complaint received 18 October 2007; case completed 28 January 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 7.2 (breach); Clause 7.4 (breach); Clause 9.5 (breach); Clause 18.4 (no breach); Clause 7.2 (no breach on open-label point)
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A general practitioner complained about an insert distributed with the September 2007 issue of Guidelines in Practice, titled “Making an informed choice. A guide to changing to CFC-free beclometasone inhalers”.
The insert stated it was supported by an unrestricted educational grant from Teva UK Ltd and included prescribing information for Qvar (CFC-free beclometasone dipropionate) on the inside back cover.
The complainant initially believed the insert was a balanced account comparing Qvar and Clenil Modulite, but after reviewing the evidence alleged it was not balanced, fair or accurate and was potentially misleading and biased.
The Panel considered Teva’s involvement: Teva initiated the supplement, commissioned an agency to work with an author, reviewed it through Teva’s approval process, paid for distribution (21,000 copies), supplied 5,000 copies to its sales force, and instructed representatives to use it proactively in calls.
The Panel concluded there was no arm’s length arrangement and that the supplement was, in effect, a paid-for insert promoting Qvar.
Specific allegations assessed included: omission of relevant plasma cortisol data (Gross et al) while citing Davies et al; omission of Gross et al symptom-free day findings while citing Price et al; omission of Juniper and Buist (1999) in a quality-of-life discussion; an overly general quality-of-life conclusion with incorrect referencing; and references to the MHRA in the insert.

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Breach ruled for misleading presentation/omission of relevant data in the “Clinical trial evidence” section regarding plasma cortisol (Clause 7.2).
No breach ruled for not stating that Fireman et al (2001) was open-label (Clause 7.2).
Breach ruled for misleading omission of Gross et al symptom-free day information while presenting Price et al findings (Clause 7.2).
Breach ruled for misleading omission of Juniper and Buist (1999) in the quality-of-life section (Clause 7.2).
Breach ruled for an overly general quality-of-life claim and incorrect referencing (Clauses 7.2 and 7.4).
No breach ruled regarding an alleged implication that Teva provided a nurse service to a named PCT (Clause 18.4).
Breach ruled for reference to the MHRA in promotional material where not specifically required by the licensing authority (Clause 9.5).

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Clause 7.2 (misleading claims/omissions): Breach (plasma cortisol evidence; symptom-free days omission; quality-of-life section omission; quality-of-life conclusion too general).
Clause 7.4: Breach (quality-of-life concluding statement found too general given the cited data and referencing issues).
Clause 9.5: Breach (reference to the MHRA in promotional material not specifically required by the Agency).
Clause 18.4: No breach (extra clinics/nurse service allegation).

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