AUTH/3510/5/21 - Complainant v Lundbeck

Alleged promotion of Vypeti (eptinezumab) at a Lundbeck-funded event

  • Received
    27 April 2021
  • Case number
  • Applicable Code year
  • Completed
    01 April 2022
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, contactable complainant complained about the promotion of Vypeti (eptinezumab) at an event entitled ‘Migraine Preceptorship’ which was organised and funded by Lundbeck Limited.

The complainant stated that the event took place in November 2020 and the participants included an expert patient, a patient organisation representative and several health professionals (ranging from a consultant neurologist to a specialist nurse). Lundbeck UK representatives were also present at this meeting. Lundbeck had a pipeline product for migraine called ‘Vypeti (Eptinezumab)’ which was a calcitonin gene-related peptide (CGRP) class of product. A session on day one was described on the agenda as ‘The future of migraine treatments; how do clinicians, patients and patient organisations view new treatments (and CGRPs), is this exciting and innovative? What impact will they have?’. This session involved discussion amongst all the attendees at the meeting on yet to be licensed eptinezumab (Vypeti). The complainant alleged that this was promotion of a product prior to licence to health professionals and it was also inappropriate to discuss this product or even the class of treatments considering the Lundbeck pipeline product within the same class. The topic should not have been discussed in the presence of a patient organisation representative and an expert patient; use of the wording ‘exciting’ and ‘innovative’ during the discussion and on the agenda were inappropriate and was to increase interest from attendees. On day two of the meeting, there were further panel Q&A discussions which, again, discussed and mentioned migraine treatments including CGRPs (calcitonin gene-related peptides).

The complainant alleged that health professionals presenting had been paid far above the normal market rate for their participation at the event considering they were being promoted to about pipeline.

The complainant further stated that Lundbeck also claimed on the invitations that whilst Lundbeck had selected key topics for discussion, content had been ultimately determined by a named academy. This could not have been accurate as Lundbeck discussed a pipeline product of its own.

The detailed response from Lundbeck is given below.

The Panel noted Lundbeck’s submission that the Migraine Preceptorship Programme, was organised by Lundbeck to provide internal training for relevant Lundbeck head office staff and no sales representatives were present. The Panel noted Lundbeck’s submission that it had contracted the named academy to design training to address four key topics set out by Lundbeck to increase its head office employees’ knowledge of the migraine therapy area and associated treatments.
The Panel noted the declaration, ‘This activity had been funded by Lundbeck. Whilst Lundbeck has selected key topics for discussion, content has been ultimately determined by [named academy’. Noting Lundbeck’s explanation, the Panel did not consider that the complainant had established that the declaration was inaccurate as alleged, and no breach was ruled.

The Panel noted Lundbeck’s submission that none of the health professionals at the meeting were delegates; they had been contracted to deliver internal company training. The Panel noted that Lundbeck did not specifically comment on the complainant’s concern about the presence of a patient organisation representative and an expert patient. The Panel noted, however, that an expert patient and member of the patient organisation were listed on the preceptorship invitation as speakers and thus also appeared not to have attended the meeting as delegates.

The Panel noted that the complainant bore the burden of proof and had provided no details about the presence and role of the speakers throughout the meeting. That individuals had been present at meetings as speakers under bona fide arrangements was insufficient, in the absence of additional evidence, to establish that they were thereby the subject of promotional activity. The Panel thus did not consider that there was evidence that eptinezumab had been promoted to any health professional, patient or patient organisation representative prior to the grant of its marketing authorisation as alleged and no breach of the Code was ruled including Clause 2.

The Panel noted that the complainant bore the burden of proof and did not consider that he/she had established that the payments made to the speakers were inappropriate as alleged. The Panel therefore ruled no breach of the Code including Clause 2.

The Panel did not consider that there was any evidence that payments to the healthcare academy faculty constituted an inducement to prescribe, supply, administer, recommend, buy or sell any medicine and no breach of the Code was ruled.

With regard to the complainant’s concern that use of the words ‘exciting’ and ‘innovative’ during the discussion and agenda was inappropriate and was used to increase interest from attendees, the Panel noted that the agenda included ‘FOR INTERNAL USE ONLY’ in bold black font at the bottom of the invitation and the complainant’s concern appeared to be in relation to external attendees. There was no evidence to support the complainant’s allegation that the words ‘exciting’ and ‘innovative’ were the subject of discussion. The Panel further noted its comments above about the status of the external attendees as speakers, as opposed to delegates, and based on the very narrow allegation, ruled no breach of the Code.