AUTH/3229/7/19 - Complainant v GlaxoSmithKline

Promotion of Relvar Ellipta

  • Received
    26 July 2019
  • Case number
  • Applicable Code year
  • Completed
    09 December 2019
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the February Review

Case Summary

A complainant who described him/herself as a ‘concerned UK health professional’, complained about a two-page advertisement for Relvar Ellipta (fluticasone furoate/vilanterol) placed in the April 2019 edition of Pulse by GlaxoSmithKline UK Limited. Relvar Ellipta was a combination of an inhaled corticosteroid (ICS (fluticasone furoate)) and a long-acting beta2 agonist (LABA (vilanterol)). Relvar Ellipta was indicated for, inter alia, the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicine was appropriate in patients not adequately controlled with ICS and as needed inhaled short- acting beta2 agonist (SABA) or patients adequately controlled on both ICS and LABA.

The first page of the advertisement featured the question ‘Which ICS/LABA helps more patients improve asthma control?’ all written in upper case with ‘helps more’ and ‘asthma control’ given particular prominence. The second page featured pack shots of the Relvar Ellipta devices and the claim ‘Relvar Ellipta was superior to other ICS/LABAs (usual care) in helping more patients improve asthma control in everyday clinical practice in the Salford Lung Study’ in small font. This was followed by a second paragraph ‘The most commonly used ICS/LABAs were Seretide (fluticasone propionate/salmeterol), Symbicort [budesonide, formoterol fumarate dihydrate], Fostair [beclometasone dipropionate, formoterol fumarate dihydrate]. Data presented are from a subset of patients in the PEA [primary effectiveness analysis] population prescribed ICS/LABA at randomisation’. The claims were referenced to the Salford Lung Study and GlaxoSmithKline data on file.

The complainant noted the claim that Relvar was superior to other ICS/LABAs and that no statistics of any sort were placed on the advertisement. The complainant stated that none of the trials listed in the Relvar summary of product characteristics (SPC) were superiority trials and the SPC stated that ‘No comparative studies versus salmeterol/FP [fluticasone propionate] or versus other ICS/LABA combinations have been conducted to appropriately compare the effects on asthma exacerbations’ (Section 5.1).

The complainant noted there was no mention of this in the advertisement which instead solely focussed on real world evidence without giving any context of the other evidence – such as the licensed indication which was narrower than the patients in the Salford Lung Study. The advertisement stated that the data presented was from a subgroup of the Salford Lung Study but the primary endpoint was not mentioned. The complainant alleged that GlaxoSmithKline had promoted Relvar off-licence, the first statement made no mention of which patients were on treatment and what was claimed was not supported by current data; by implying it could improve all patients it exaggerated the use of the medicine and high standards had not been maintained.

The detailed response from GlaxoSmithKline is given below.

The Panel noted that Section 5.1 of the Relvar SPC stated that no comparative studies vs [Seretide] or vs other ICS/LABA combinations had been conducted to appropriately compare the effects on asthma exacerbations. This section of the SPC also included data from a 24 week study in adult and adolescent patients demonstrating an overall improvement in lung function for both Relvar and Seretide; the adjusted mean treatment difference between the groups was not statistically significant. For trough FEV1 the difference in the mean change from baseline between the Relvar group and the Seretide group was not statistically significant. The same section of the SPC referred to a randomised, double-blind 24 week non-inferiority study in adults and adolescents in which subjects randomised to Relvar maintained lung function comparable with those randomised to Seretide.

The Panel noted that the Salford Lung Study was in patients with asthma aged 18 or over whereas Relvar was licensed for patients aged over 12. This was not made clear in the advertisement. Nor was any information provided about the asthma control test. Although the advertisement referred to everyday clinical practice readers might expect that the differences described in the advertisement were also found in double-blind clinical trials. In the Panel’s view readers would be interested in the results of the Salford Lung Study but it was important that sufficient information was given about the study. The context of claims was important. The Salford Lung Study was not included in the Relvar SPC. This was of course not necessarily a breach of the Code. The Code required that material was not inconsistent with the SPC. Results from studies not in the SPC must not contradict the SPC and should be presented in the context of the information within the SPC.

The Panel considered that the failure to set the results of the Salford Lung Study in the context of the study’s limitations and other study data about Relvar meant that the advertisement was misleading and exaggerated the effects of Relvar and was a misleading comparison with other ICS/LABAs. Readers would assume that the study results applied to all those eligible to be prescribed Relvar and that was not so. The Panel ruled breaches of the Code. The Panel noted that statistics did not necessarily need to be included in material but it was important that readers were provided with sufficient information to enable them to form their own opinion of the therapeutic value of the medicine. Claims etc had to be capable of substantiation. In the Panel’s view the overall misleading impression given by the advertisement could not be substantiated so a further breach was ruled.

The Panel noted that the first question ‘Which ICS/LABA helps more patients improve asthma control?’ which was the only claim on the first page of the advertisement did not mention which patients were on treatment. The Panel did not consider on balance that the absence of such detail meant that the promotion of Relvar was inconsistent with its SPC as alleged and ruled no breach of the Code.

The Panel ruled a breach as the advertisement did not maintain high standards.