AUTH/3388/9/20 - Complainant v Daiichi-Sankyo

Alleged promotion of Lixiana, Nilemdo and Nustendi to the public

  • Received
    24 September 2020
  • Case number
  • Applicable Code year
  • Completed
    22 April 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Complainant appeal

Case Summary

An anonymous, contactable complainant who described him/herself as a member of the public complained about the promotion of Lixiana (edoxaban), Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) to the public by Daiichi-Sankyo UK. Lixiana was indicated for the treatment and prevention of certain thrombotic conditions and Nilemdo and Nustendi were both for use in certain adults with lipid or cholesterol disorders.

The complainant noted that a congress organised by a UK patient organisation, was about to take place. The public website listed the agendas of the live sessions and there was no signage to indicate it was for health professionals only. The complainant provided a web link to the congress programme.

The complainant noted that on 28 September there would be a ‘Daiichi NN [congress] Live Symposia’. The agenda listed one session as ‘The clinical challenges we face in dyslipidaemia’. The next session was ‘Introducing Nilemdo and Nustendi’, followed by ‘Who is Nilemdo and/or Nustendi right for?’. The complainant submitted that this linked Nilemdo and Nustendi with the indication dyslipidaemia on a public website.

Similarly, the complainant noted that on 29 September the ‘Daiichi Lixiana [congress] Live Symposia’ with a session title of ‘Tackling unmet need in NVAF’ would take place; this linked Lixiana to the indication NVAF on a public website.

The complainant stated that there was no prescribing information, black triangle, adverse event reporting information, date of preparation or generic name for Nilemdo, Nustendi or Lixiana.

The complainant stated there was no declaration of the company’s involvement for either symposia. That the symposia were listed on the ‘live sessions’ page suggested that they were part of the official congress agenda for the meeting, rather than company sponsored sessions.

The complainant alleged that high standards had not been maintained and that it had brought discredit on the industry.

The detailed response from Daiichi-Sankyo is given below.

The Panel considered the relationship between Daiichi-Sankyo and the patient organisation relevant to the complaint. The company sponsored both the patient organisation, as an organisation, and the congress, which was organised by it. Part of the congress sponsorship appeared to include two symposia. The Panel considered that the advertising of the pharmaceutical company symposia by the patient organisation was potentially covered by the Code and would be the responsibility of the pharmaceutical company. It did not appear that the relationship between Daiichi-Sankyo and the patient organisation with regard to the two symposia and the exhibition stand was a strictly arm’s length arrangement given that the symposia were Daiichi-Sankyo organised meetings, rather than sponsored by the company. The Panel was concerned that there were no clear instructions from Daiichi-Sankyo to the patient organisation about each party’s role in relation to the symposia and the need to comply with the Code in promoting the symposia. It did not appear that Daiichi-Sankyo had provided the patient organisation with the wording for the symposia agenda to be used on the congress website. The statement of works provided appeared to be from the patient organisation to Daiichi-Sankyo.

The Panel noted that the weblink provided by the complainant was to the Live Sessions programme on the congress website. As listed on the programme for 2020 these included, ‘12:00 – 13:00 Daiichi NN [congress] Live Symposia Online – Monday 28 September’ and ‘12:00-13:00 Daiichi Lixiana [congress] Live Symposia Online – Tuesday 29 September’. The agenda for each symposia appeared below on the same webpage. The Panel noted that the agenda made reference to Daiichi-Sankyo medicines, Lixiana, Nilemdo and Nustendi, and their associated therapeutic areas of use.

The Panel noted that it appeared that the complainant had accessed the Live Sessions programme directly from the congress website. The homepage of the website stated that the congress provided ‘…unrivalled opportunity for health care professionals interested in the management of arrhythmias to share effective practice, showcase innovation, learn about latest developments and network with UK & international delegates’. It was clear that the congress was aimed at health professionals. The Panel further noted Daiichi-Sankyo’s submission that the congress and a link to the congress homepage was only listed on the health professional section of the patient organisation’s website and therefore was not promoted to non-health professionals.

In the Panel’s view, the congress website was aimed at health professionals and not aimed at the public and therefore it did not consider that the agenda for the two Daiichi-Sankyo symposia on the webpage in question, which appeared in the programme section of the website, promoted prescription only medicines to the public as alleged and no breaches of the Code were ruled.

With regard to the allegation in relation to the lack of prescribing information and other obligatory information on the webpage in question, the Panel disagreed with Daiichi-Sankyo’s submission that the agenda on the webpage in question was not promotional. The Panel considered that the mention of Daiichi-Sankyo’s medicines in association with their respective indications on the webpage at issue meant that the Code requirements applied. The Panel therefore ruled breaches of the Code for lack of prescribing information, omission of non-proprietary name immediately adjacent to the brand name at its first appearance, lack of a clear prominent statement as to where the prescribing information could be found, lack of a date on which the material was drawn up, lack of the adverse event reporting statement and omission of the inverted black triangles for each of Nilemdo, Nustendi and Lixiana, respectively, as alleged.

The Panel noted Daiichi-Sankyo’s submission that it was a platinum sponsor of the congress and that the presentation of the agenda as displayed on the congress website was formatted and created by the patient organisation.

The Panel noted, however, that there was no sponsorship declaration on the webpage for readers to immediately understand the extent of the company’s involvement and sponsorship of the entire meeting, rather than the Daiichi-Sankyo symposia. The contract with the patient organisation, as stated in the statement of work provided, made no reference to the requirement for a sponsorship statement in this regard. The Panel ruled a breach of the Code.

The Panel considered that its ruling of a breach of the Code in relation to the sponsorship of the meeting as a whole covered the matter in relation to the inadequate declaration of sponsorship and therefore the Panel ruled no breaches of the Code.

The Panel was concerned to note that Daiichi-Sankyo’s contract with the patient organisation did not refer to the requirements of the Code in relation to declaration of sponsorship and it appeared to the Panel that Daiichi-Sankyo had not adequately briefed the organisers with regards to the requirements of the Code in relation to presentation of the company symposia agenda on the programme at issue. The Panel considered that Daiichi-Sankyo had failed to maintain high standards in this regard and a breach of the Code was ruled.

The Panel noted its comments and rulings above and 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 reserved for such use. No breach of Clause 2 was ruled which was upheld on appeal by the complainant.