AUTH/3417/11/20 - Complainant v Daiichi-Sankyo

Alleged promotion of Lixiana on YouTube

Case Summary

An anonymous, contactable patient complained about the promotion of Lixiana (edoxaban) on YouTube by Daiichi-Sankyo UK. Lixiana was an anticoagulant indicated for the prevention and treatment of certain thrombotic events.

The complainant explained that he/she took an anticoagulant and found the YouTube video sponsored by Daiichi-Sankyo UK on a page run by a medical education company. The video was a recording of a meeting that happened on 8 July 2020.

The complainant noted that there was a company logo at the beginning of the video but no other explanation of the company involvement and the speaker did not mention that the video was sponsored by the company until five minutes had lapsed. The complainant stated that he/she did not think it was true that the company had had no input; there were four slides which must have been produced by the company and they promoted its medicine. The complainant queried how the third party medical education company received these slides if the company had not provided them and asked for them to be inserted in return for sponsorship. Breaches of the Code were alleged including that the slides were disguised promotion.

The complainant alleged that the video promoted edoxaban to the public because YouTube was a public site and there was nowhere in the video or on the YouTube page that said only health professionals should watch the video. Breaches of the Code were alleged.

The complainant stated that if it was promotion, the company should provide some information such as prescribing information and details to report adverse events and but there should have been a black triangle where edoxaban was mentioned on the slides. Breaches of the Code were alleged.

Given all of the above, the complainant queried whether the company had even scrutinised and approved or ‘certified’ the video and in that regard he/she alleged breaches of the Code.

The complainant stated that this led to a further question of whether the speakers were under a contract with Daiichi-Sankyo given that this was a promotional meeting with slides provided by the company, but the speaker stated the company had no involvement in the content. The complainant alleged a breach of the Code if there were no proper contracts instructing the speaker to accurately describe the company's involvement.

The complainant alleged that the company had not maintained high standards and that this kind of underhand activity, to falsely claim no involvement in the content of a meeting, reduced confidence in the pharmaceutical industry in breach of Clause 2.

The detailed response from Daiichi-Sankyo is given below.

The Panel noted Daiichi-Sankyo’s submission that the YouTube video in question was of the medical education company-organised main clinical session from a meeting initiated and coordinated by the medical education company held on 8 July 2020. Daiichi-Sankyo had provided sponsorship for the meeting and in return was able to provide speakers for some parts of the agenda.

The Panel noted Daiichi-Sankyo’s submission that the agenda was split into a formal clinical session and several Daiichi-Sankyo sponsored sessions; the medical education company had selected half of the speakers and Daiichi-Sankyo had selected the other half. Daiichi- Sankyo stated that it had full control in selecting, briefing and contracting the speakers for its sponsored sessions. Daiichi-Sankyo did not have any involvement in identifying attendees for the event.

The Panel made its ruling on the basis of the five screenshots provided by the complainant.

The Panel noted Daiichi-Sankyo’s submission that neither it nor the medical education company had uploaded the presentation onto YouTube for public viewing. According to Daiichi-Sankyo the medical education company routinely made the recordings available via a portal and delegate dashboard linked to the non-public YouTube infrastructure to those delegates. The medical education company used an unlisted YouTube channel to store the recording so that it could edit it and provide a version to the delegates. The Panel noted Daiichi-Sankyo’s submission that the recordings could not be accessed by the public, or anyone else, unless they had the direct link and that the only people with access to the link provided by the complainant were the delegates attending the event who were all confirmed as health professionals. If the link was entered into a Google web browser that search would nonetheless identify the video in question.

It appeared to the Panel that the video in question could only be accessed via a specific link which had only been made available to delegates. On the limited information before the Panel, it appeared unlikely, on the balance of probabilities, that the video would be accessed by searching YouTube or the wider internet. The Panel also bore in mind Daiichi-Sankyo’s submission that the screenshots of the video in question provided by the complainant appeared to have been accessed by the link provided to delegates. The Panel considered that the complainant had not established, on the balance of probabilities, that the publication of the video in question on YouTube meant that it was available to the public as alleged. In any event, it appeared that Daiichi-Sankyo had no role whatsoever in relation to the publication of the video in question. No breaches of the Code were ruled.

The Panel noted Daiichi-Sankyo’s submission that the target audience of the meeting was pharmacists, and the content of the recording was appropriate for that audience. Noting its comments above about the publication of the video the Panel did not consider that the complainant had provided evidence that the recording had been sent or distributed by Daiichi-Sankyo to anyone whose need for or interest in it could not be reasonably assumed and no breach of the Code was ruled.

The Panel noted Daiichi-Sankyo’s submission that whilst it certified the presentations in its company sessions, it did not initiate or influence the content of the presentation in the video in question, did not choose the speaker and therefore did not review the slides. The Panel noted that the speaker in the video in question had access to Daiichi-Sankyo slides from a different project and had, without the company’s permission, used some of those slides in the presentation in question which was not under Daiichi-Sankyo’s control. The Panel noted Daiichi-Sankyo’s submission that it had included the appropriate mandatory information in its presentations, however, the material shown in the video in question was not promotional content created by or for Daiichi-Sankyo. The Panel considered, on the evidence before it, that Daiichi-Sankyo was not responsible for the content of the presentation in question in relation to the clauses cited and, in that regard, ruled no breaches of the Code.

The Panel noted Daiichi-Sankyo’s submission that it did not choose the speaker or initiate or influence the content of the presentation shown in the recording. Nor had the company paid the speaker in question in relation to his/her presentation. The Panel therefore ruled no breach of the Code.

The Panel considered that Daiichi-Sankyo had been badly let down by the speaker of the presentation in question who had been a consultant of Daiichi-Sankyo’s in a previous project and had re-purposed Daiichi-Sankyo material in his/her presentation without the company’s permission and this had contributed to the misleading impression that Daiichi-Sankyo was involved with the content of that particular session which was not so. Furthermore, the medical education company appeared not to have followed its own policies as it did not review the slides from the presentation in question and the moderator did not intervene to prevent any ‘un-reviewed’ slides from being displayed. It was a well-established principle that companies were responsible under the Code for the acts and omissions of its consultants and third parties working on its behalf. However, the Panel noted, that in this particular case, the speaker in question was not acting as a consultant to the company and the medical education company was not working on Daiichi-Sankyo’s behalf. Daiichi-Sankyo had provided sponsorship to the medical education company for the entire meeting and in return Daiichi-Sankyo was able to provide speakers for some sessions on the agenda. Those sessions were labelled as optional and signposted on the agenda as ‘Sponsored by Daiichi-Sankyo’. The Panel noted that according to Daiichi-Sankyo delegates had to visit a separate virtual room to access these sessions and in the Panel’s view, Daiichi-Sankyo was responsible under the Code for the content of these sessions. The Panel considered, however, that in the particular circumstances of this case Daiichi-Sankyo was not responsible for the content of the independent sessions that it had no influence on, which included the session in the YouTube video in question. The Panel noted its comments above and considered that there was no evidence to show that Daiichi-Sankyo had failed to maintain high standards in that regard and no breach of the Code was ruled.

The Panel noted that the Code stated that material relating to medicines and their uses, whether promotional or not, and information relating to human health or diseases which is sponsored by a pharmaceutical company must clearly indicate that it has been sponsored by that company. The supplementary information stated that the declaration of sponsorship must be sufficiently prominent to ensure that readers of sponsored material are aware of it at the outset. The wording of the declaration must be unambiguous so that readers would immediately understand the extent of the company’s involvement and influence over the material. The Code stated that when meetings are sponsored by pharmaceutical companies, that fact must be disclosed in all of the papers relating to the meetings and in any published proceedings. The declaration of sponsorship must be sufficiently prominent to ensure that readers are aware of it at the outset.

The Panel noted that Daiichi-Sankyo’s logo appeared on two slides of the presentation at issue provided by the complainant; the first slide and the slide displaying the agenda for the whole meeting. Further, four of the slides discussing edoxaban were Daiichi-Sankyo branded slides. Whilst noting Daiichi-Sankyo’s submission that the speaker re-purposed material from a different Daiichi-Sankyo project without the company’s permission and that the Daiichi-Sankyo sessions at the virtual meeting in question were signposted as such, it did not consider that Daiichi-Sankyo’s sponsorship of the meeting overall and its lack of involvement in the particular session was sufficiently clear from the outset of the presentation. A company logo was considered insufficient in this regard and a verbal briefing about sponsorship did not negate the need for a written unambiguous declaration of sponsorship. Further, the Panel did not know what was said in the verbal briefing. Breaches of the Code were ruled. High standards had not been maintained in that regard and a breach of the Code was ruled.

Clause 2 was a sign of particular censure and was reserved for such use. The Panel noted its comments and rulings above and did not consider that the particular circumstances of this case warranted a ruling of this clause and therefore no breach of Clause 2 was ruled which was upheld on appeal by the complainant.