CASE/0218/06/24 NO BREACH OF THE CODE
COMPLAINANT v ASTRAZENECA
Allegations about a video
CASE SUMMARY
This case was in relation to a recording of a webinar hosted on the promotional website for Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide). The complainant alleged that the video failed to mention palpitations as being a common adverse effect, made a misleading and inaccurate claim regarding recommendation by NICE and GOLD, discussed out-of-date information, and disparaged another pharmaceutical company’s product.
The outcome under the 2021 Code was:
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No Breach of Clause 5.1 (x4)
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No Breach of Clause 6.1 (x3)
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No Breach of Clause 6.2
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No Breach of Clause 6.6
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No Breach of Clause 9.1
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This summary is not intended to be read in isolation.
For full details, please see the full case report below.
FULL CASE REPORT
A complaint about AstraZeneca UK Limited was received from a contactable complainant who described themselves as a health professional. The complainant later became uncontactable.
COMPLAINT
The complaint wording is reproduced below:
“Trixeo promotional video hosted on the Trixeo website has misleading claims. GB-55207, Feb 2024. The title of the video is Cardipulmonary [sic] risk management and has 2 HCPs presenting. [link provided] The following are the issues within the video:
1. The video focused on cardiovascular risk management, however it fails to mention within the video that a common cardiac adverse effect of Trixeo is palpitations. This is a patient safety consideration. promotional content should always be balanced and provide all information especially as the content was within the context of Trixeo. Breaches of clauses 6.1, 5.1 and 2
2. At 18 minutes 15 seconds, it is claimed that NICE and GOLD guidelines recommend Trixeo when other LABA/LAMA or LABA/ICS have failed. This is a misleading and inaccurate claim as NICE only recommend a 3 month trial of Trixeo if day to day symptoms affect quality of life. Trixeo is also only recommended by NICE if there is 1 severe or 2 moderate exacerbations a year, not just exacerbations as the slide claimed. GOLD only recommend triple therapy if LABA/LAMA has failed, GOLD do not recommend step up from ICS/LABA. The guidance from NICE and GOLD on use of triple therapy is very specific but the information is omitted by use of the broader claim on recommendations from NICE and GOLD presented. The HCP speaker should have been briefed on the exact recommendations made in NICE and GOLD. Use outside of guideline recommendations is a patient safety risk. Breach of clauses 6.1, 6.2, 5.1, 2
3. GOLD report discussed was out of date as GOLD had a 2024 guideline but video discussed the 2023 guideline. Information should always be up to date. Breach of clauses 6.1, 5.1
4. The video was disparaging to Trimbow considering the video implied Trixeo had a lower cardiovascular risk. Breach of clauses 6.6 and 5.1.”
When writing to AstraZeneca, the PMCPA asked it to consider the requirements of Clauses 6.1, 6.2, 6.6, 9.1, 5.1 and 2 of the 2021 Code.
ASTRAZENECA’S RESPONSE
The response from AstraZeneca is reproduced below:
“Thank you for your letter dated 28th June 2024, concerning a complaint from a Healthcare Professional regarding a video on the Trixeo product website. The job number provided by the complainant (GB-55207) isn’t for a Trixeo related asset. We believe the correct job number for the video subject to complaint is GB-52207 (Trixeo SC Webinar on demand – Cardiopulmonary Risk Management – hosted on Trixeo website page: [link provided]).
AstraZeneca has been asked to consider the requirements of Code clauses 6.1, 6.2, 6.6, 5.1 and 2 of the 2021 ABPI Code of Practice. We will therefore address each of the complainant’s allegations according to the relevant clauses.
Background
The Trixeo product website is a promotional website intended for UK healthcare professionals (HCPs). It includes information about Trixeo, COPD, Aerosphere technology and hosts resources for HCPs and their patients. Anyone accessing the website has to declare that they are a UK HCP before they see any promotional content. The video subject to the complaint is a recording of a webinar (meeting held in 2023). The video is hosted on the resources page. This page can be found by clicking on the ‘Resources for HCPs’ link in the header of the Trixeo website wireframe.
This webinar was developed in collaboration with the two speakers, who are both experts in the topics discussed. AstraZeneca collaborated closely with the speakers throughout the development of the programme. The HCPs were verbally briefed on the content of the slides and ABPI Code of Practice requirements. AstraZeneca’s commitment to remain compliant with the ABPI Code of Practice is also agreed with speakers as part of their contract. The webinar took place on December 13th 2023. The presentation slides were reviewed and approved by a Nominated Signatory prior to the meeting, on 27th November 2023. AZ employees attended the webinar to support and ensure the meeting happened as planned.
In our response to these allegations, this letter will establish that:
• The video does not focus on cardiovascular risk management, instead, it highlighted the importance of optimal management of COPD and COPD exacerbations in light of the risk of serious cardiopulmonary events associated with the disease. There was presentation of efficacy and safety data for Trixeo, in the context of COPD management only. We therefore refute any breach of Clauses 6.1, 5.1 and 2 of the Code on this point.
• The information presented relating to the NICE guideline and GOLD management strategy is accurate, balanced, and capable of substantiation, and therefore this does not represent a breach of Clauses 6.1, 6.2, 5.1 or 2 of the Code.
• At the time of recording the video, the GOLD 2024 management strategy had been recently published (4 Dec 2023). The meeting presentation slides had already been certified. The team reviewed the 2024 GOLD report vs 2023 GOLD report, and noted that the information due to be presented at the meeting was the same in both reports. As the relevant sections in the GOLD 2024 management strategy are unchanged from the 2023 version, they were appropriate in this context. We do not consider this a breach of clauses 6.1 or 5.1 of the Code.
• There is no comparison either made or implied between Trixeo and Trimbow, there has been no disparaging of another product and therefore there is no breach of either Clauses 6.6 or 5.1.
The complaint alleges issues in four areas;
Allegation 1
1. ‘The video focused on cardiovascular risk management, however it fails to mention within the video that a common cardiac adverse effect of Trixeo is palpitations. This is a patient safety consideration. promotional content should always be balanced and provide all information especially as the content was within the context of Trixeo.’
Alleged breach 6.1, 5.1 and 2
AstraZeneca Response:
Contrary to complainant’s allegation, the video is not focused on cardiovascular risk management. The first part of the presentation is about understanding the risk of both serious cardiovascular and pulmonary events (cardiopulmonary risk) associated with COPD, in particular, exacerbations of COPD and the impact of these events, which is an emerging priority in the scientific and clinical community (Wells et al. 2023; Hurst & Gale 2024, Singh et al. 2024). The intent of this section is to highlight the importance of optimal management of COPD, a disease which is often under-prioritised in clinical practice.
The presentation then goes on to discuss pharmacological intervention options, mentioning triple therapy and listing all available options which support the management of COPD, and specifically the reduction of COPD exacerbations. As an AZ promotional webinar, the presentation then focused on Trixeo (one of the triple therapy options). Data from the Phase 3 study of Trixeo in moderate to severe COPD (ETHOS) was presented in the context of the observed efficacy and safety in managing COPD. There was no linkage to any direct impact of Trixeo on cardiovascular or cardiopulmonary risk. Of the five slides presented on the Trixeo data, one focuses solely on safety and highlights all adverse events (AEs) with an incidence rate of 3% or more which is consistent with the reporting of AEs in the original scientific publication [Rabe et al. 2020].
Additionally, a single-click direct link to the Trixeo Prescribing Information is clearly visible above the video on the website, allowing HCPs to review all necessary prescribing information (including complete safety and adverse event information), before prescribing. In addition, the PI states at the top for HCPs to ‘Consult the Summary of Product Characteristics before Prescribing’
In summary, the video did not focus on cardiovascular risk management, instead, it highlighted the importance of optimal management of COPD and COPD exacerbations in light of the risk of serious cardiopulmonary events associated with the disease. We therefore refute any breach of Clauses 6.1, 5.1 and 2 of the Code on this point.
Allegation 2
2. ‘At 18 minutes 15 seconds, it is claimed that NICE and GOLD guidelines recommend Trixeo when other LABA/LAMA or LABA/ICS have failed. This is a misleading and inaccurate claim as NICE only recommend a 3 month trial of Trixeo if day to day symptoms affect quality of life. Trixeo is also only recommended by NICE if there is 1 severe or 2 moderate exacerbations a year, not just exacerbations as the slide claimed. GOLD only recommend triple therapy if LABA/LAMA has failed, GOLD do not recommend step up from ICS/LABA. The guidance from NICE and GOLD on use of triple therapy is very specific but the information is omitted by use of the broader claim on recommendations from NICE and GOLD presented. The HCP speaker should have been briefed on the exact recommendations made in NICE and GOLD. Use outside of guideline recommendations is a patient safety risk.’
Alleged breach of clauses 6.1, 6.2, 5.1, 2
AstraZeneca’s Response
There is no discussion of guidelines or the recommendation of Trixeo at 18 minutes and 15 seconds in the video as claimed by complainant. We assume the complainant is referring to the slide shown in the video from 18 minutes 55 seconds (see below).
[Screenshot of the video at issue at approximately 18 minutes 55 seconds]
Whilst presenting this slide, the presenter talks about the components of triple therapy, refers to the three combinations available in the UK, and quotes the therapeutic indication for Trixeo specifically. The information provided on the slide and presented is intended to provide a topline introduction to triple therapies before discussing the Trixeo data in detail on subsequent slides. The presenter doesn’t verbally reference the first bullet point or discuss triple therapy position in the guidelines when presenting this slide. The guidelines are presented in detail later on in the presentation (see slide below), which includes the details mentioned by the complainant:
• Consideration of the 3-month trial of LABA + LAMA + ICS (for persons with day-to-day symptoms that adversely impact quality of life), and
• Consideration of LABA + LAMA + ICS (persons with 1 severe or 2 moderate exacerbations within a year)
[Image of the slide presented at approximately 24 minutes 41 seconds]
The complainant has acknowledged that GOLD guidelines recommend triple therapy if LABA/LAMA has failed as mentioned on the slide ‘Triple therapies are a single-inhaler combination of LABA/LAMA/ICS’ shown above. Regarding LABA/ICS, GOLD guidelines no longer recommend LABA/ICS in COPD, instead recommend that ‘If there is an indication for an ICS, then LABA+LAMA+ICS has been shown to be superior to LABA+ICS and is therefore the preferred choice.’ However, it does provide recommendations for patients already on LABA/ICS. If the patient is ‘is well controlled in terms of symptoms and exacerbations, continuation with LABA+ICS is an option’, however if the patient has ‘further exacerbations, treatment should be escalated to LABA+LAMA+ICS’ [see GOLD report 2023, page 118-119].
Based on the detailed explanation above, information was not omitted to mislead the audience, but to introduce triple therapy treatment options for COPD exacerbations and then further information on the guidelines presented on the subsequent slide. AZ refutes the allegations made by the complainant that the above information was misleading and inaccurate. We, therefore refute breaches of Clauses 6.1, 6.2, 5.1 or 2 of the Code.
Allegation 3
3. ‘GOLD report discussed was out of date as GOLD had a 2024 guideline but video discussed the 2023 guideline. Information should always be up to date.’
Alleged breach of clauses 6.1, 5.1
AstraZeneca’s Response
At the time of recording the video, the GOLD 2024 management strategy had been recently published (4 Dec 2023). The meeting slides had already been certified (certified on 27th November 2023). The team reviewed the 2024 GOLD report vs 2023 GOLD report, and noted that the information due to be presented at the meeting was the same in both reports. As the relevant sections in the GOLD 2024 management strategy are unchanged from the 2023 version, they were appropriate in this context.
As such, use of the GOLD 2023 management strategy remains accurate and appropriate in the context in which it is used and therefore we do not consider this a breach of clauses 6.1 or 5.1 of the Code.
Allegation 4
4. ‘The video was disparaging to Trimbow considering the video implied Trixeo had a lower cardiovascular risk.’
Alleged breach of clauses 6.6 and 5.1
AstraZeneca’s Response
Trimbow is mentioned (as its generic name) on slide 18 under the heading ‘Three inhalers are currently available on the market’, where it then lists ‘Budesonide/glycopyrronium/formoterol (AstraZeneca); Beclomethasone dipropionate/formoterol/glycopyrronium (Chiesi); Fluticasone furoate/vilanterol/umeclidinium (GSK)’. No product names are provided for the Chiesi and GSK products. This is accompanied by the speaker stating ‘There are three on the market you can see there. We’re going to focus on budesonide, glycopyrronium and formoterol, which is TRIXEO’. There are no comparisons between Trixeo and either of the two other available triple combinations, nor mentions of other products later on in the presentation.
As there has been no comparison either made or implied between Trixeo and Trimbow, there has been no disparaging of another product and therefore there is no breach of either Clauses 6.6 or 5.1.
We therefore refute the alleged breach of clauses 6.1, 6.2, 6.6, 5.1 and 2 of the ABPI Code of Practice.
AstraZeneca takes its responsibilities under the ABPI Code very seriously. Based on the above detailed response, AZ has maintained high standards and its activities have not brought the industry into disrepute. Therefore, we refute the breach of Clause 5.1 and 2 the Code.”
PANEL RULING
The complaint concerned a recording of a webinar that was hosted on the ‘resources’ webpage of a promotional website for Trixeo (formoterol fumarate dihydrate/glycopyrronium/budesonide). Trixeo was a single-inhaler triple therapy indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who were not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA).
The Panel noted AstraZeneca’s submission that the job number provided by the complainant (GB-55207) did not relate to a Trixeo asset. AstraZeneca provided a copy of a video (GB-52207) which matched the complainant’s description and the video available from the URL provided by the complainant. The Panel determined that the complainant had likely made a typographical error and based its ruling on the video provided by AstraZeneca.
The webinar was titled “Transforming COPD Care: Cardiopulmonary risk management” and was labelled “For UK Healthcare Professionals only”.
The Panel considered each of the complainant’s allegations in turn.
Allegation 1: Failure to mention palpitations as a common adverse effect
The Panel considered the allegation that the webinar video focused on cardiovascular risk management and failed to mention palpitations as being a common adverse effect of Trixeo.
The Panel noted that Section 4.8 of the Trixeo summary of product characteristics (Undesirable effects) included a table of adverse reactions by frequency and system organ class. Palpitations was included as the only common adverse reaction listed under “Cardiac disorders”. There were several other adverse reactions categorised as common.
Clause 6.1 of the Code required that information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous, that they must not mislead and that material must be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine. The supplementary information to this clause required that claims in materials must be capable of standing alone as regards accuracy, etc.
The Panel considered that whether a common adverse effect needed to be highlighted within promotional material, in addition to the requirement for it to be included within the prescribing information that was required on all promotional material, depended on a consideration of all the circumstances. This would include taking account of factors such as the content, layout, audience and intended use of the material.
AstraZeneca submitted that the webinar video was not focused on cardiovascular risk. The first part of the presentation was about understanding the cardiopulmonary risk associated with COPD and to highlight the importance of optimal management of COPD. The second part discussed pharmacological intervention options, mentioning triple therapy.
The Panel noted that, during the second part of the video, slides on the ETHOS trial were presented, including one which included the adverse events recorded in that trial. Palpitations was not included in this list, and the Panel determined that this was consistent with the information in the publication to which this information was referenced. In the Panel’s view, this slide did not misleadingly imply that this was a comprehensive list of the adverse effects related to Trixeo or the other treatments.
The Panel considered the content of the full webinar video. It appeared to be primarily about informing health professionals about the risk of cardiopulmonary events associated with COPD, with a focus on triple therapy and Trixeo in the second half of the presentation.
The Panel considered that the purpose of the presentation was not a focus on cardiovascular risk, as alleged. The Panel considered that palpitations was one of a number of common adverse reactions included in the Trixeo summary of product characteristics and that, given the context of the presentation, there was no requirement for it to be highlighted over and above any of the others. The Panel accepted AstraZeneca’s submission that the Trixeo prescribing information was made available alongside the video and that it included the appropriate adverse event information.
In the Panel’s view, the complainant had not established that the webinar video was incomplete or unbalanced because it did not mention palpitations as a common adverse event, and the Panel ruled no breaches of Clauses 6.1, 5.1 and 2, accordingly.
Allegation 2: A misleading and inaccurate claim regarding recommendation by NICE and GOLD
The Panel considered the complainant’s allegation that, within the webinar video, it was claimed that NICE and GOLD recommended Trixeo when other LABA/LAMA or LABA/ICS treatments had failed. The complainant alleged that this broad claim was misleading and inaccurate because:
• NICE only recommended a three-month trial of Trixeo if day-to-day symptoms affected a patient’s quality of life
• NICE only recommended Trixeo if there were one severe or two moderate exacerbations per year
• GOLD only recommended triple therapy if LABA/LAMA had failed – GOLD did not recommend stepping up from ICS/LABA to triple therapy.
The Panel agreed with AstraZeneca’s submission that there was no discussion of guidelines or the recommendation of Trixeo at 18 minutes and 15 seconds (the timepoint referenced by the complainant) and that the complainant most likely meant 18 minutes and 55 seconds.
The slide at 18 minutes and 55 seconds was titled “Triple therapies are a single-inhaler combination of LAMA/LABA/ICS” and included two bullet points as follows (bold text as per the slide):
“● Triple therapies are recommended in NICE and GOLD guidelines to help manage symptoms or exacerbation when other LABA/LAMA or LABA/ICS have failed
● Three inhalers are currently available on the market
– Budesonide/glycopyrronium/formoteral (AstraZeneca)
– Beclomethasone dipropionate/formoterol/glycopyrronium (Chiesi)
– Fluticasone furoate/vilanterol/umeclidinium (GSK)”
Below these bullet points was a banner which stated: “Introducing TRIXEO (formoterol fumarate dihydrate/glycopyrronium/budesonide) 5/7.2/160 µg”, followed by the indication for Trixeo.
The Panel also took account of the speaker’s verbal comments during this section of the video. The speaker explained that triple therapy inhalers were a single-inhaler combination of LAMA/LABA/ICS, that there were three available on the market, and that the webinar would focus on Trixeo. The speaker read out the indication for Trixeo. The speaker made no comment about the NICE or GOLD recommendation. The Panel considered that the speaker was setting the scene for the next section of the presentation, which was focused on the ETHOS phase 3 clinical trial.
Given the focus on Trixeo in the subsequent slides, the Panel considered that, overall, the presentation should be sufficiently complete to enable viewers to form their own opinion on the therapeutic value of Trixeo. While the Panel recognised that the statement on the slide about triple therapies being recommended by NICE and GOLD lacked the detail of the specific recommendations, on balance and given the overall context of the webinar including the speakers’ verbal commentary, the Panel did not consider that health professionals would expect one slide, with a single reference to NICE guidance and the GOLD Report, to contain all the relevant information contained in the specific recommendations for the use of single inhaler triple therapy. Having considered the immediate and overall impression of the slide in question and the entire presentation, the Panel concluded that the complainant had not established that the statement at issue was misleading, inaccurate or could not be substantiated. The Panel therefore ruled no breaches of Clauses 6.1 and 6.2.
The Panel did not consider that Trixeo was likely to be used outside of the guidance recommendations as a result of a health professional viewing this video, or that there was a consequent risk to patient safety. The Panel therefore ruled no breaches of Clauses 5.1 and 2.
The case preparation manager had asked AstraZeneca to consider the requirements of Clause 9.1 in its response to the complaint and the Panel considered that this was in relation to the complainant’s comment that “The HCP speaker should have been briefed on the exact recommendations made in NICE and GOLD”. The Panel noted that AstraZeneca had not commented on this clause in its response letter.
Clause 9.1 required, amongst other things, that contracted individuals involved in the preparation of materials covered by the Code were fully conversant with its requirements and that companies ensured that any materials were consistent with the Code.
In addition to its rulings of no breaches of the Code above, the Panel took account of the following points:
• AstraZeneca submitted that the two speakers were verbally briefed and therefore no written briefing document was available to the Panel
• Neither speaker spoke about the NICE or GOLD recommendations during the part of the video referred to by the complainant
• One speaker talked more about the presence of triple therapies in the NICE guidance and GOLD strategy later in the video, but did not go into any detail about the circumstances in which Trixeo was recommended
• Paragraph nine in both speakers’ contracts required that they perform their services “in compliance with all applicable laws, regulations and codes of practice relevant to the pharmaceutical industry”
• In signing the contract, the speakers confirmed that they had “been adequately briefed by AstraZeneca and read and understood the ‘Guidelines for External Speakers’”.
The Panel concluded that there was no evidence that AstraZeneca had failed to ensure that the two speakers were fully conversant with the requirements of the Code or that the webinar materials were inconsistent with the Code; the complainant had not established their case in this regard. The Panel therefore ruled no breach of Clause 9.1.
Allegation 3: Discussion of out-of-date information
The complainant alleged that the 2023 GOLD report discussed in the webinar video was out of date.
The Panel accepted AstraZeneca’s response in relation to this allegation, that the GOLD 2024 management strategy was published on 4 December 2023. AstraZeneca submitted that the presentation slides had been certified prior to this date, on 27 November 2023, and the video at issue was recorded shortly after this date, on 13 December 2023. Regarding the information from the GOLD report presented in the webinar, AstraZeneca submitted that the relevant sections in the GOLD 2024 management strategy were unchanged from the 2023 version.
Clause 6.1 required, among other things, that information, claims and comparisons must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly.
The Panel bore in mind that the complainant bore the burden of proof and had to establish their case on the balance of probabilities. The Panel did not consider that the complainant had established their case in relation to this allegation – they had not provided any specific examples of information in the webinar video which they considered to be out of date due to the update to the GOLD report. The Panel therefore ruled no breaches of Clauses 6.1 and 5.1.
Allegation 4: Disparagement of another pharmaceutical company’s product
The complainant alleged that the webinar video was disparaging about Chiesi’s product, Trimbow (beclometasone/formoterol/glycopyrronium), because it implied that Trixeo had a lower cardiovascular risk.
Clause 6.6 required that the medicines, products and activities of other pharmaceutical companies must not be disparaged.
The Panel noted that the only mention of Trimbow within the webinar video was on slide 18 of the presentation, which listed the three single-inhaler triple therapies currently available on the market, including beclometasone/formoterol/glycopyrronium. They were listed using the non-proprietary name and corresponding company only – the brand name, Trimbow, was not included. The speaker stated that there were three such inhalers available on the market but that the focus of the presentation would be on Trixeo. There was no comparison made between Trixeo and Trimbow within either the slides or the presenters’ verbal presentations.
The Panel bore in mind that the complainant bore the burden of proof and had to establish their case on the balance of probabilities. The Panel did not consider that in the particular circumstances of this case, the complainant had established their case in relation to this allegation – the Panel considered there was no evidence that Trimbow had been disparaged either on the slides or in the speaker’s commentary. The Panel therefore ruled no breaches of Clauses 6.6 and 5.1.
Complaint received 27 June 2024
Case completed 19 May 2025
