AUTH/3531/7/21 - Anonymous v Novartis

Concerns about Lucentis advertised in UK ophthalmic journals

  • Received
    01 July 2021
  • Case number
    AUTH/3531/7/21
  • Applicable Code year
    2019
  • Completed
    23 February 2022
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous non contactable complainant who described him/herself as an optometrist raised concerns around claims for Novartis Pharmaceutical UK Limited’s product, Lucentis (ranibizumab).

The complainant alleged that claims of ‘Powerful. Proven. Targeted.’ were made with no context and no supporting data. ‘Powerful’ was meaningless and had no data to support it. ‘Proven’ was meaningless without context. Proven to do what? ‘Targeted’ was misleading without context. Targeted to the eye? Targeted to diabetes? Targeted to VEGF (vascular endothelial growth factor)? Targeted to a particular retinal layer? ‘Treat DMO patients at the maximum possible interval’ - what was that: a month, a year?

The detailed response from Novartis is given below.

The Panel noted that the complainant referred to two journal advertisements and a Novartis webpage, on its health professional website, which had the claim ‘Powerful. Proven. Targeted.’ beneath the Lucentis (ranibizumab) logo; the claim was referenced to the SPC. The Panel considered that the claim overall was a strong claim and each element needed to be capable of substantiation. Such substantiation did not need to be provided in the material.

The Panel considered that the strong claim ‘Powerful’ was ambiguous; it was not clear what was meant by it and it was not linked to any feature of the product. Novartis acknowledged this in its response and did not provide any substantiation. The Panel therefore ruled breaches of the Code in relation to each advertisement and the webpage at issue, as acknowledged by Novartis.

The Panel considered that as Lucentis had a marketing authorisation, it was ‘proven’ in relation to its use for the licensed indication being advertised. Although there was no detail about what was ‘proven’, the Panel did not consider that in these circumstances, the complainant had established, on the balance of probabilities, that its use was misleading as alleged. The Panel therefore ruled no breaches of the Code in relation to each advertisement and the webpage at issue.

The Panel further noted Novartis’ submission that the claim ‘Targeted’ was a reference to the specific mechanism of action of Lucentis which was fully described within its summary of product characteristics (SPC). Whilst the Panel did not consider this was clear from the material at issue, it did not consider that in the particular circumstances of this case the complainant had established on the balance of probabilities that the use of ‘targeted’ was misleading as alleged. The Panel therefore ruled no breaches of the Code in relation to each advertisement and the webpage at issue.
With regard to the claim ‘Lucentis allows you to treat your DMO patients at the maximum possible interval’, which appeared beneath the heading ‘Lucentis Treat and Extend’, in one of the advertisements (ref MLR 114580), the Panel noted that further information was included in the advertisement. Directly below the claim it stated ‘Treatment in adults is initiated with one injection per month until maximum visual activity is achieved and/or there are no signs of disease activity, after which you can extend the patient out by up to one month a time’. Below this, there was a diagram which set out possible dosing intervals for various months in either phase 1, loading dose or phase 2, treat and extend. This was described as a potential algorithm for a DMO patient using Lucentis treat and extend. The advertisement stated that this was not necessarily reflective of the treatment schedule for all patients as this would depend on their individual disease activity. The Panel considered that the advertisement included an explanation of the time interval and ruled no breach of the Code.

The Panel noted its comments and rulings of breaches of the Code above and considered that Novartis had failed to maintain high standards and a breach of the Code was ruled.

The Panel 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.