AUTH/3515/5/21 - Complainant v GlaxoSmithKline

Activities at a meeting and promotion of Seretide

  • Received
    21 May 2021
  • Case number
    AUTH/3515/5/21
  • Applicable Code year
    2019
  • Completed
    16 November 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    Respondent appeal

Case Summary

An anonymous, non-contactable health professional complained about the promotion of Seretide (fluticasone/salmeterol) by GlaxoSmithKline UK Limited. The material at issue was an online registration page for a GlaxoSmithKline organised and funded webinar held in May 2021 and a claim on a Seretide webpage. Seretide was indicated in certain patients with asthma.

The detailed response from GlaxoSmithKline is given below.

A Webinar: ‘Patient Management in Severe Asthma - Evolution & Evidence’

The complainant noted that the online registration page for the webinar referred to World Asthma Day in May and national respiratory expert speakers. There was a summary of the webinar content and prescribing information for various products. Three of the medicines mentioned were Trelegy (fluticasone/vilanterol/umeclidinium), Anoro (vilanterol/umeclidinium) and Incruse (umeclidinium), all of which were licensed for chronic obstructive pulmonary disease (COPD) not asthma. The complainant alleged that it was inappropriate to have mentions/prescribing links to medicines which were not asthma treatments and busy health professionals would think that these three medicines were licensed for asthma use.

The complainant also referred to a named speaker who was a medical department employee at GlaxoSmithKline and alleged that it was inappropriate for a non-promotional member of staff to be present on a promotional webinar to solicit questions for the medical team. This blurred lines between promotional staff and non-promotional staff.

The Panel noted that the registration page at issue promoted an asthma-focussed webinar and that it included links to prescribing information for a number of GSK medicines including Trelegy, Anoro and Incruse which were licensed for use in COPD but not in asthma.

The Panel considered that the immediate and overall impression was that the listed medicines including Trelegy, Anoro and Incruse were licensed for use in asthma, which was not so; a breach of the Code was ruled for each medicine as acknowledged by GlaxoSmithKline. The Panel considered that high standards had not been maintained and a breach of the Code was ruled.

The Panel considered that the reference to Trelegy, Anoro or Incruse on the registration page for the asthma-focussed webinar, within a list of medicines which could be used in asthma, was wholly inappropriate particularly given that Section 4.4, Special warning and precaution for use of the summary of product characteristics (SPC), for Trelegy, Anoro and Incruse stated that they should not be used in patients with asthma since they had not been studied in that patient population. The Panel considered that the implied suggestion otherwise was such as to reduce confidence in the pharmaceutical industry and ruled a breach of Clause 2. On appeal by GlaxoSmithKline, the Appeal Board considered that the implied suggestion that the medicines could be used in asthma was a matter of patient safety and such as to reduce confidence in the pharmaceutical industry. The Appeal Board upheld the Panel’s ruling of Clause 2.

The Panel did not consider that, in acting as Chair for the promotional webinar, the medical department employee had taken on the role of a representative ie that he/she called on members of the health professions and other relevant decision makers in relation to the promotion of medicines. The Panel did not consider that it was necessary for the employee to have taken an appropriate examination for medical representatives as alleged and ruled no breach of the Code.

The Panel noted its rulings and comments above and ruled no breaches of the Code including Clause 2.

B Web page claim: ‘Seretide Evohaler - a combination ICS/LABA treatment for asthma. Now over £5 cheaper than Fostair at medium dose’.

The complainant alleged that the claim was misleading and not in line with the Seretide licence. The licensed indication for Seretide had specific age ranges for use and children less than four years old were not to use Seretide. The complainant alleged that the big, bold headline claim of 'asthma' patients at the outset of the webpage implied any patient with asthma was suitable for treatment with Seretide which was not the case and was a patient safety risk.

The Panel noted that the webpage at issue included an image of the three Seretide inhalers which were different strengths. Beneath the image of the three inhalers was the claim ‘Seretide Evohaler ‐ a combination ICS/LABA treatment for asthma Now over £5 cheaper than Fostair at medium dose’. The Panel noted that it was thus clear from the outset that Seretide was a combination product.

The Panel considered that health professionals would be familiar with the well-defined, step-wise guidelines which existed for the treatment of asthma and that once they had considered that treatment with an ICS/LABA was appropriate for a patient, Seretide, as a brand, would be one of the available options. The Panel noted that Seretide Evohaler was available in three formulations and considered that prescribers would be mindful to always use the lowest dose of corticosteroid possible. The Panel noted that although only the lowest strength of Seretide Evohaler could be used in the age group four to eleven, there was nonetheless a formulation of Seretide which could be prescribed. The Panel further noted GlaxoSmithKline’s submission that immediately below the claim in question was a section entitled ‘What is Seretide Evohaler?’ which included that Seretide Evohaler 50/25 was licensed for use in paediatric asthma for ‘patients 4 years and above’ and that further down the webpage was a tab entitled ‘Paediatric license’, which detailed the dosing requirements of Seretide in paediatric patients aged over four years when clicked.

The Panel noted its comments above and did not consider that health professionals would be misled by the claim as alleged. The Panel did not consider that the claim was inconsistent with the particulars listed in the Seretide Evohaler SPC, nor that the claim could not be substantiated, and so it ruled no breaches of the Code including no breach of Clause 2.