GSK: ERS 2022 symposium highlights video ruled misleading on NMA-based COPD comparisons (Trelegy) (AUTH/3715/11/22)

📅 2022 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3715/11/22
CompanyGSK
Complaint received28 November 2022
Case completed18 December 2023
Applicable Code year2021
MaterialERS 2022 symposium highlights video on GSK respiratory promotional website (Trelegy Ellipta promotional site)
MedicineTrelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI)
Therapy areaCOPD
Main issueMisleading implication of statistically significant exacerbation benefits vs comparators (including other SITTs) based on NMA presentation and voiceover
Breach clausesClause 5.1; Clause 6.1 (x4); Clause 6.2 (x2); Clause 14.1 (x4)
No breach clausesClause 2; Clause 6.6 (x2)
SanctionsUndertaking received; Additional sanctions: Not stated
AppealNo appeal

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

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What happened

  • An anonymous, contactable complainant challenged a video on GSK’s UK respiratory promotional website (Trelegy Ellipta site) summarising a GSK ERS 2022 symposium.
  • The video presented results from a GSK network meta-analysis (Ismaila et al) comparing Trelegy (FF/UMEC/VI) with other triple and dual COPD therapies, including other single-inhaler triple therapies (SITTs) such as Trimbow and Trixeo.
  • The complaint focused on two parts of the video:
    • A slide/headline and voiceover about “greater improvements” in annualised moderate/severe exacerbations vs “most comparators”, and a spoken claim implying statistical significance vs other SITTs.
    • A conclusions slide/voiceover that, in the Panel’s view, blurred statistical significance for lung function with “greater improvement” for exacerbations, creating an overall impression that exacerbation reductions were statistically significant vs alternative therapies.
    • The complainant also alleged health professionals had been paid to provide misleading claims.
    • GSK accepted that one spoken use of “significantly” in relation to exacerbation outcomes vs other SITTs was inaccurate and was not picked up in certification; GSK withdrew the video version.
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Outcome

  • Breach of Clause 5.1 (Failing to maintain high standards).
  • Breach of Clause 6.1 (x4) (Making a misleading claim).
  • Breach of Clause 6.2 (x2) (Making a claim incapable of substantiation).
  • Breach of Clause 14.1 (x4) (Making a misleading comparison).
  • No Breach of Clause 2 (Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
  • No Breach of Clause 6.6 (x2) (Requirement that another company’s medicines must not be disparaged).
  • No breach was found for the allegation that HCPs had been paid to provide misleading claims (the Panel said the complainant had not established this).
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