AUTH/3469/2/21 - Complainant v Takeda

‘ASH 2020 Highlights’ online meeting

  • Received
    02 February 2021
  • Case number
  • Applicable Code year
  • Completed
    23 July 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous contactable complainant, who described him/herself as an oncologist in the UK, complained about an online meeting, ‘ASH [American Society of Hematology] 2020 Highlights’ on 21 January 2021 organised by Takeda UK Limited.

Ninlaro (ixazomib) was indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who had received at least one prior therapy. Takeda also marketed Adcetris (brentuximab vedotin) which was indicated in certain patients with Hodgkin lymphoma, systemic anaplastic large cell lymphoma, and cutaneous T-cell lymphoma.

The complainant stated that the topics were very good and there were four or five top speakers who spoke and answered questions. There was more time speaking and only a few minutes for questions and answers which was quite disappointing, but perhaps organised like that because of Covid.

The complainant was surprised that Takeda had run meetings where medicines which did not have a licence were discussed eg ixazonib for first line use in myeloma. The complainant queried whether there were rules that forbade companies from doing that. The complainant queried if the medicines were safe if the Medicines and Healthcare products Regulatory Agency (MHRA) had not given them the OK. The complainant knew this was common in oncology but questioned whether Takeda wanted health professionals to prescribe its medicines after the meeting as it certainly felt like it. The names of the medicines also had a black triangle and queried whether Takeda was saying that health professionals should report side effects for unlicensed medicines? The complainant was also surprised to see an advertisement for the meeting on Twitter which was how he/she registered in the first place. Did that mean companies should not be talking about medicines online?

The detailed response from Takeda is given below.

The Panel noted the broad definition of promotion in the Code and that although the promotion of a medicine prior to the grant of its marketing authorisation was prohibited, the Code permitted companies to undertake certain activities with regard to unlicensed medicines and/or indications. The legitimate exchange of medical and scientific information during the development of a medicine was not prohibited provided that this did not constitute promotion. Informal PMCPA guidance stated that companies must ensure that such activities constituted a genuine exchange of information and were not promotional. The legitimate exchange of scientific information during the development of a medicine should involve debate that enhanced the current state of scientific knowledge. To avoid being seen as promotional, it should not be a one-way flow of information.

The Panel noted that slide 10 stated that the meeting was an interactive meeting and encouraged attendees to submit questions and some of the speakers included a slide titled questions at the end of their presentations to encourage questions. Materials advertising the meeting referred to it as being an interactive virtual meeting and invitedquestions and discussion from the audience. The invitation included that there would be dedicated time for Q&A and discussion with the speakers. It went on to state that to ensure a lively debate and help attendees make the most of the scientific exchange meeting, it encouraged them to fully partake in the discussion and Q&A sessions with the expert speakers following each presentation. Similarly the registration page encouraged readers to take part in the Q&A and discussion following each presentation. Further tweets sent by the speakers included I hope you can join us to debate and discuss key haemato-oncology data from ASH’.

The Panel noted that the briefing to the chair and speakers stated that the overall objectives of the meeting would be to exchange and discuss new clinical research, advances and challenges in the management of haematological malignancies including lymphoma and myeloma. In addition the service brief for the Chair highlighted that their responsibilities included, inter alia, chairing the scientific exchange session at the end of the meeting programme and taking questions from the webinar audience. The brief to speakers stated ‘Please include the relevant abstracts from ASH that you believe will be of most interest to UK/Ireland clinical practice. Please ensure that in your presentation the licence status of any medicines is made clear. The Panel noted Takeda’s submission that there was no request to discuss data on Takeda products if indeed any was available in the therapeutic area. However, the brief to speakers included a reference to lymphoma and myeloma, two areas in which Takeda had interests and licensed medicines. The invitation included the speakers’ names and topics, these being multiple myeloma, low grade lymphoma, high grade lymphoma and Hodgkin’s lymphoma.

The Panel further noted Takeda’s submission that a verbal briefing call with the chair and speakers highlighted various points including that the meeting was a scientific exchange meeting, meaning it should include 2 way discussion and debate as opposed to a 1 way presentation followed by Q&A.

The Panel noted that after each 20 minute presentation 5 minutes were set aside for Q&A and a further 15 minutes was set aside for a panel discussion at the end of the meeting. The Panel noted that each speaker had between 43 and 92 slides and queried whether this number of slides could have been properly presented within 20 minutes thus leaving the allotted time for Q&As. In this regard the Panel noted that 53% of the attendees provided feedback and three of the comments related to providing more time for questions and discussion. The lowest score was in relation to whether adequate time was given for discussion. The Panel noted the list of seventeen questions asked by delegates of which two appeared not to be questions related to the meeting content.

The Panel further noted the number of attendees at the session (192) and queried whether the company could be confident that all delegates were each able to meaningfully contribute to a discussion that enhanced the current state of scientific knowledge.

The Panel noted that despite encouragement by both Takeda and the speakers, there was very little evidence of any legitimate scientific exchange.

The Panel noted Takeda’s submission that the style and tone of the slides and presentation was scientific and no use of brand names was included. Further that the meeting covered a broad number of topics and medicines, which included information on two Takeda medicines and the company’s submission that this did not take up an undue proportion of the information presented and all unlicensed information was clearly stated as such on the relevant slides. In the Panel’s view, the presentation did not overall give disproportionate emphasis to Takeda’s products. The topics presented appeared to relate to lymphoma or myeloma rather than haematological malignancies including lymphoma or myeloma as in the brief from Takeda.

The Panel noted that the presentation gave attendees the opportunity to talk to the Takeda oncology medical team after the meeting. The Panel considered that the presentation was likely to raise interest in relation to all of the products referred to including Takeda’s and thus it might be argued that Takeda was soliciting questions about its medicines including for an unlicensed indication. In the Panel’s view, it was reasonable to assume that, on the balance of probabilities, attendees might ask about Takeda’s medicines.

The nature and depth of discussion was fundamental to the legitimate exchange of medical and scientific information. The Panel queried whether the arrangements for the presentation were conducive to the legitimate exchange of scientific information during the development of a medicine. In the Panel’s view, the cumulative effect of the large number of detailed slides presented within a short period of time, the lack of discussion, and the question mark over whether all 192 attendees could contribute to scientific debate was such that, on balance, the meeting was not the legitimate exchange of scientific and medical information during the development of a medicine.

The Panel noted that ixazonib was a licensed medicine and that its alleged promotion for first line use in myeloma, was an unlicensed indication. The Panel noted its comments above that the meeting did not constitute legitimate exchange of medical and scientific information and therefore could not take the benefit of the relevant supplementary information. The Panel noted that the meeting discussed the unlicensed use of ixazonib for first line use in myeloma and, in the Panel’s view, promoted it for an unlicensed indication. The Panel ruled a breach of the Code. It ruled no breach in relation to the alleged promotion of an unlicensed medicine.

The Panel considered that high standards had not been maintained and a breach of the Code was ruled.

The Panel did not consider that the promotional nature of the meeting had been disguised and ruled no breach of the Code.

With regard to the advertisement for the meeting on Twitter, the Panel was unclear what the complainant’s allegation was in this regard. The Tweets linked to the registration site which required delegates to confirm that they were UK/Ireland health professionals. The Panel thus ruled no breach of the Code in that regard.

The Panel noted Takeda’s submission that for best practice it decided to use the black triangle symbol where its medicines which had an existing licence were mentioned (ixazomib and brentuximab vedotin). Takeda considered it diligent to include a reminder to report adverse events and that the products were subject to additional monitoring. However, any slides with unlicensed indications for a Takeda medicine were clearly marked as such. The Panel did not consider that by including the black triangle in relevant slides, Takeda failed to maintain high standards and no breach of the Code was ruled.

The Panel noting its comments and ruling above did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and was reserved for such use. No breach of the Code was ruled.