AUTH/3331/4/20 - Complainant v GlaxoSmithKline

Promotion of Relvar in Pulse magazine

  • Received
    15 April 2020
  • Case number
  • Applicable Code year
  • Completed
    05 October 2020
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned UK health professional complained about an advertisement for Relvar Ellipta placed in the December edition of Pulse magazine by GlaxoSmithKline. Relvar Ellipta was a combination of an inhaled corticosteroid (ICS (fluticasone furoate)) and a long-acting beta2 agonist (LABA (vilanterol)).

The complainant alleged that the generic name was not next to the most prominent mention of the brand name and that what was claimed was not supported by current data. By implying it could improve 25% of patients it was exaggerating the use of the medicine since this was extrapolating from data that was already non-comparative and therefore should not be used to make comparisons.

The detailed response from GlaxoSmithKline is given below.

The Panel noted GlaxoSmithKline’s submission that following the Panel ruling in Case AUTH/3229/7/19 and the undertaking given, GlaxoSmithKline withdrew the material at issue in this current complaint in December 2019. It appeared to the Panel that the complaint was in relation to the advertisement as it appeared online and the Panel therefore made its rulings in relation to the requirements for electronic advertisements The non-proprietary name appeared immediately below the headline introducing Relvar Ellipta on the first page of the double page spread and the Panel therefore ruled no breach of the Code.

The Panel noted that the advertisement included the claim ‘Choosing Relvar could help 25% more patients improve asthma control vs other ICS/LABAs’ which was followed by ‘In a real-world study, ACT responders for Relvar were 70% vs. 56% for the other ICS/LABA arm; absolute difference 14%. Study had minimal exclusion criteria and minimal intervention.’ The claim was referenced to Woodcock et al and contained the results of the Salford Lung Study.

The Panel noted that Section 5.1 of the Relvar SPC stated that no comparative studies versus salmeterol/FP or versus 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 fluticasone furoate/vilanterol and salmeterol/FP; 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 fluticasone furoate/vilanterol group and the salmeterol/FP 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 fluticasone furoate/vilanterol maintained lung function comparable with those randomised to salmeterol/FP.

The Panel noted that the Salford Lung study referred to showed that the proportion of ACT responders was 70% for the Relvar arm and 56% for the comparator arm (usual care) and noted GlaxoSmithKline’s submission that this absolute difference of 14% equated to 25% of the 56% of comparator responders and was how the figure of ‘25% more’ was arrived at. The Panel noted that as far as the usual care group was concerned, no specific medicines (other than other ICS/LABA) or doses were identified in the study. However, there was a comparison of treatments and this was contrary to the allegation. The Panel considered that the claim was not misleading or exaggerated as alleged and the claim was substantiated by the study which included a comparison of Relvar with usual care. The Panel therefore ruled no breaches of the Code including that GlaxoSmithKline had not failed to maintain high standards.