AUTH/3450/1/21 - Complainant v Lundbeck

Promotion of Brintellix (vortioxetine)

  • Received
    05 January 2021
  • Case number
  • Applicable Code year
  • Completed
    05 August 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 a health professional, complained about the promotion of Brintellix (vortioxetine) by Lundbeck Limited.

The complainant stated that a representative from Lundbeck provided him/her with a weblink to view on-demand content for Brintellix on a webpage was entitled ‘Clinical experience of emotional blunting and data on the efficacy of vortioxetine on anhedonia’. The event registration page stated ‘This webinar is organised and funded by Lundbeck’ and there was a large Brintellix product logo. Below the logo it stated, ‘Vortioxetine is indicated for the treatment of major depressive episodes in adults’. There was no prescribing information or adverse event reporting provided; it was stated that these would be available but they were not on the registration page to access.

The complainant noted that there was no disclaimer to make the page accessible for health professionals only, and that anyone, including members of the public, could have entered the registration page, where the product and indication were stated, and registered for and watched the webinars. The representative had said that access was not restricted as the webinar could be found through a search engine using the terms ‘Brintellix UK webinar’.

The detailed response from Lundbeck is given below.

The Panel noted that the webinar was, according to Lundbeck, a promotional event organised by its global team based in Denmark and directed at health professionals across nine European countries, including the UK. The webinar was held as a ‘live’ event in May 2020 and was subsequently made available as ‘on demand’ recorded content; it was for local affiliates to distribute this information to health professionals in their respective countries.

The Panel noted that an invite to the live webinar was emailed by Lundbeck representatives to UK health professionals who had opted in to receive promotional materials. The email included an invitation and a biography of the speaker, both of which included embedded prescribing information. If a health professional accepted the invitation, they were sent a specific URL link to the registration page; this email included prescribing information as an attachment; information on accessing the ‘on demand’ content was only sent to those who had originally accepted the invitation to the live event.

The Panel noted that contrary to the complainant’s statement, the screenshot of the registration page showed that the registration form contained numerous data entry fields including job title. According to Lundbeck, once health professionals had registered on the platform, a due diligence process was followed to ensure that they were a health professional and their suitability to access the promotional webinar validated. The Panel further noted Lundbeck’s submission that access to the registration page was through a closed email invitation to specific health professionals; neither the registration page nor the webinars were advertised to the public or hosted on any publicly available platform.

The Panel noted Lundbeck’s submission that it was highly improbable that a member of public would search the three specific terms ‘Brintellix’, ‘UK’ and ‘webinar’, together, and thus access the registration page. Representatives were not instructed to provide this direction to access the webinar and Lundbeck was unable to identify any evidence that this occurred.

The Panel noted that the Lundbeck event should not have been searchable on Google. The platform providers explained how the event might have appeared in a Google search, despite not being requested by Lundbeck.

The Panel considered that it appeared measures were in place to ensure the registration page and webinar were only accessed by invited health professionals; the registration page was hosted on a closed platform with search optimisation disabled. It appeared to the Panel that the only way the registration page or webinar might be found via a search engine was using very specific search terms and only after a search engine had found the link by some other means and indexed it to make it searchable. The Panel noted that there was no evidence that specific search terms had been highlighted by the company or that the registration page or event was advertised to the public; no breach of the Code was ruled. The Panel did not consider that the complainant had discharged his/her burden of proof, that Lundbeck had promoted Brintellix to members of the public as alleged and no breaches of the Code were ruled.

The Panel noted that the information displayed on the registration webpage included the Brintellix product logo, its indication and the title of the webinar ‘Clinical experience of emotional blunting and data on the efficacy of vortioxine on anhedonia’ and considered that the page was thus promotional. The Panel noted that the registration page did not include the prescribing information or adverse event reporting statement as alleged and breaches of the Code were ruled as acknowledged by Lundbeck.

The Panel noted Lundbeck’s submission that whilst the event registration page was certified by Lundbeck and uploaded to the webpage, due to a misinterpretation of the Code, a global employee instructed the platform provider to change the UK job code on the registration page and main event page so that it aligned with the job code on the certified webinar slides. The job code of the final form of the registration page was thus amended after certification and the subsequent uncertified registration page was available.

The Panel considered that the final form of the registration page had been amended following certification, and therefore it ruled a breach of the Code as acknowledged by Lundbeck. The Panel noted that a robust certification procedure underpinned self-regulation and considered that high standards had not been maintained. It appeared to the Panel that Lundbeck had been let down by one of its global colleagues who had amended the job code but no other information following certification.

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 was reserved for such use, and no breach was ruled.