AUTH/3452/1/21 - Complainant v Lundbeck

Promotion of Abilify

  • Received
    14 January 2021
  • Case number
  • Applicable Code year
  • Completed
    10 November 2021
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Respondent appeal

Case Summary

An anonymous, contactable complainant who described him/herself as a health professional, complained about the promotion of Abilify Maintena (aripiprazole) prolonged-release suspension for injection by Lundbeck and in that regard provided a link to a particular webpage on the Lundbeck UK Progress in Mind Psychiatry and Neurology resource centre website.

Abilify Maintena was an atypical antipsychotic indicated for the treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

The complainant stated that a Lundbeck medical science liaison (MSL) had provided him/her with information about a non-promotional educational resource website/hub where Lundbeck had written non-promotional articles for UK health professionals. Although the website was designed to provide non-promotional articles, there was disguised promotion of Abilify in an article entitled ‘Towards new treatment options for MDD [major depressive disorder] and schizophrenia: a role for D2 receptor partial agonists’. The bottom of the article stated ‘This Symposia was conducted with educational financial support provided by H. Lundbeck A/S’.

The complainant stated that Abilify was a well-established and well-known dopamine D2 receptor partial agonist and atypical antipsychotic. The article had deliberately over emphasised the mechanism of action and medicine class to mask the product name. The complainant was also concerned that the article recommended off-label usage as Abilify was licensed for maintenance treatment of schizophrenia and the article promoted it for use in depression. The complainant was concerned that a promotional article was placed onto what was described as an educational hub for health professionals. The complainant alleged that Lundbeck had deliberately avoided the name of the medicine as it was off-label but by repeated reference to mechanism of action and atypical antipsychotics it was clear that the article was promotional for Abilify instead of being an educational article. The complainant was also concerned that the article suggested there were fewer undesirable side effects with Abilify which was not so. The article was based on a symposium that took place in Mexico which was then used to construct an inappropriate promotional article for UK health professionals including off-label recommendations.

The detailed response from Lundbeck is given below.

The Panel noted that Lundbeck accepted the article was promotional, however it never intended for it to be placed on the Lundbeck UK Progress in Mind website or to be provided to any UK health professional. The Panel noted Lundbeck’s submission that Lundbeck UK had no involvement in supporting the Lundbeck global symposia or in the development of the article following it.

The Panel noted Lundbeck’s submission regarding the activities of former members of staff and was concerned to note that according to Lundbeck, a senior medical member of Lundbeck staff had created and certified the job bag for the Progress in Mind website and that the article in question was not in the job bag but was a part of the cloned global content that then appeared on the UK website. The company submitted that the website had been taken down before it had received the complaint. It appeared from the metrics provided by the company that only one person accessed the article.

The Panel considered that the article promoted Abilify Maintena and omitted mandatory information such as the prescribing information, and where it could be found as well as the adverse events reporting statement. The Panel ruled breaches of the Code in that regard as acknowledged by Lundbeck.

The Panel considered that whilst it was clear that it was a Lundbeck UK website and it was stated at the bottom of the article ‘This Symposia was conducted with educational financial support provided by H. Lundbeck A/S’, those reading the content of the article would not necessarily be clear from the outset that the article at issue was a report from a Lundbeck meeting which was promotional for a product co-promoted by Lundbeck. The Panel considered that the promotional nature of the article was thus disguised and ruled a breach of the Code. This ruling was upheld on appeal from Lundbeck.

The Panel noted Lundbeck’s submission that if the article had been properly certified for UK use, its content would have been robustly checked to ensure all claims on Abilify’s efficacy and safety were in line with the licensed indications, accurate and capable of substantiation. However, incorrect and inappropriate information was included in this regard. The Panel therefore ruled breaches of the Code as acknowledged by Lundbeck. The Panel considered that the article by referring to the class of atypical antipsychotics, the dopamine D2 receptor partial agonists as offering new treatment options both in acute and maintenance schizophrenia and in the adjunctive treatment of major depressive disorder, promoted Lundbeck’s product, Abilify Maintena, in a manner which was not in accordance with its marketing authorisation. The Panel ruled a breach of the Code as acknowledged by Lundbeck. High standards had not been maintained and a further breach of was ruled as acknowledged by Lundbeck.

Whilst the Panel noted Lundbeck’s submissions and that a robust certification procedure underpinned self-regulation. That signatories and senior staff had not followed established Code and SOP principles in this regard resulting in an article which promoted an unlicensed indication, omitted important obligatory information and contained incorrect and inappropriate information in relation to efficacy and safety claims as acknowledged by Lundbeck brought discredit to and reduced confidence in the pharmaceutical industry. A breach of Clause 2 was ruled.