AUTH/3394/10/20 - Anonymous health professional v Novartis

Disease awareness campaign

  • Received
    04 October 2020
  • Case number
    AUTH/3394/10/20
  • Applicable Code year
    2019
  • Completed
    22 March 2021
  • 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 a health professional, complained about a patient information booklet about melanoma, ‘Melanoma. Let’s get under the skin of it’, available on the Novartis Pharmaceuticals UK Ltd website. Novartis marketed Tafinlar (dabrafenib) and Mekinist (trametinib) for use in certain melanoma patients with a BRAF V600 mutation.

The complainant noted that the booklet in question had been produced in association with Melanoma UK [a patient support organisation]. A section about ‘Therapy options’ included the statement ‘Testing for a mutation to the BRAF gene is the only way you can know if targeted therapy is an option for you. Once your doctor knows if you have the BRAF mutation, you can begin to discuss targeted therapy as a treatment option.’ The complainant noted other references to the BRAF gene and targeted therapies in the ‘Summary’ and in that regard was concerned that Novartis was indirectly pointing to its own medicine and trying to get patients to ask for targeted therapies. In reality, even if patients had a BRAF mutation it did not mean they would be prescribed that targeted therapy; it was not the only treatment option.

The complainant further noted that a woman running around in the sunshine was not a great picture for melanoma – and should not imply patients were fine to do that once treated. The complainant stated that he/she could not work out how Melanoma UK was involved in this booklet, he/she did not believe ‘in association with’ gave a clear picture of both parties’ involvement and wondered why Melanoma UK would advocate that approach.

The detailed response from Novartis is given below.

The Panel noted Novartis’ submission that the booklet was one of a number of materials produced in 2019 as part of a disease awareness campaign aimed at patients and carers.

The Panel noted that while the Code prohibited the advertising of prescription only medicines to the public it permitted information to be made available to the public about such medicines provided the information was factual and presented in a balanced way. Information must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product. Statements must not be made for the purpose of encouraging a member of the public to ask their health professional to prescribe a specific prescription only medicine. The Panel noted that the supplementary information to the Code stated that a company might conduct a disease awareness or public health campaign provided that the purpose was to encourage members of the public to seek treatment for their symptoms while in no way promoting the use of a specific medicine. The use of brand or non-proprietary names and/or restricting the range of treatments described in the campaign might be likely to lead to the use of a specific medicine. Particular care must be taken where the company’s product, even though not named, was the only medicine relevant to the disease or symptoms in question.

The Panel noted that the booklet had been developed to provide those who had recently been diagnosed with melanoma with information about melanoma gene mutations – in particular the BRAF gene – and the relevance of those mutations in making treatment decisions. The booklet stated that knowing whether you had a mutation to the BRAF gene could help patients better understand their available treatment options and that getting tested to see if their melanoma was BRAF positive was simple and the results might expand their treatment options. The section ‘Who should be tested for BRAF and why’ further stated that medicines that targeted mutations in the BRAF gene were available and had been shown to be effective in treating melanoma. The ‘Therapy options’ section discussed surgery and in particular targeted therapies and immunotherapies in relation to BRAF positive patients. The Panel noted Novartis’ submission that there were currently seven targeted treatments available including two from Novartis and five from two other pharmaceutical companies.

The Panel did not consider that the information in the booklet failed to meet the requirements of the Code. In the Panel’s view, the information was balanced and would not encourage a member of the public to ask their health professional to prescribe a specific prescription only medicine. The material might lead a member of the public to ask about being tested for the BRAF gene mutation so that available treatment options could be considered, which included, but was not limited to, Novartis’ medicines. No breach of the Code was ruled.

Given its rulings above the Panel considered that high standards had been maintained and it ruled no breaches of the Code including of Clause 2.

The Panel noted the complainant’s allegation that the photograph of a woman running around in the sunshine was inappropriate for melanoma patients. There were four images within the booklet and the Panel considered that the complaint was about the image on page two which depicted a lady walking through a field of long grass, on what appeared to be a sunny day, wearing a long sleeved top and trousers, but no hat.

The Panel noted Novartis’ submission that published NHS advice stated ‘the most common sign of melanoma is the appearance of a new mole or a change in an existing mole. This can happen anywhere on the body, but the most commonly affected areas are the back in men and the legs in women’. Novartis noted that the back and legs were areas covered by clothing in the image in question. According to Novartis, individuals with melanoma were not generally expected to entirely avoid the outdoors; it was recommended that they ‘cover up with suitable clothing’. The NHS website also advised patients to ‘aim to strike a balance between protecting yourself from the sun and getting enough vitamin D from sunlight’. The Panel noted Novartis’ submission that all of the images in the booklet were appropriate for the melanoma population. Whilst the Panel acknowledged that most patients with melanoma would not entirely avoid being outdoors, it was concerned that the woman in the image was not wearing a hat given that melanoma could occur anywhere on the body. However, and on balance, the Panel did not consider that the image implied that patients with melanoma were fine to be out in the sunshine once treated as alleged. No breach of the Code was ruled.
The Panel noted that the Code stated, inter alia, that when working with patient organisations, companies must ensure that their involvement was made clear and that all of the arrangements complied with the Code. That included the need for companies to clearly acknowledge their sponsorship from the outset.

The front page of the booklet stated ‘This material was developed by Novartis Pharmaceuticals UK Ltd, in association with Melanoma UK.’ The Panel noted Novartis’ submission that it had engaged with Melanoma UK in order to ensure the educational materials were of a high standard and appropriate for the melanoma population; Melanoma UK had the opportunity to perform an ‘offline review’ of all materials involved in the disease awareness campaign and had, in turn, endorsed the booklet and the wider campaign. The letter of agreement between the parties, written by Novartis and signed by Melanoma UK, appeared to be about the use of the Melanoma UK logo and Melanoma UK’s involvement in the campaign. It was stated that Melanoma UK would be named as a campaign partner on all the materials and that it would make those materials available on its website.

The Panel noted that it did not appear that Novartis had sponsored Melanoma UK material but rather that Melanoma UK had reviewed, endorsed and would make available on its website, Novartis material. In the Panel’s view the requirement to declare sponsorship was not relevant and no breach was ruled.

The Panel noted the complainant’s submission that he/she could not work out how Melanoma UK was involved in this booklet and his/her view that ‘in association with’ did not give a clear picture of both parties’ involvement. The Panel considered that when deciding whether the involvement of Novartis was clear on the material, the description of the role of Melanoma UK was relevant as was the nature of the intended audience. The Panel noted Novartis’ submission that the disclaimer ‘in association with’ was commonly used by pharmaceutical companies when patient groups endorsed public facing materials. The Panel disagreed with Novartis’ submission that it was synonymous with ‘developed with’, ‘in collaboration with’, ‘in partnership with’, etc and that it clearly indicated who was involved with the materials.

The Panel noted that the booklet was intended for the public and considered that the statement ‘This material was developed by Novartis Pharmaceuticals UK Ltd, in association with Melanoma UK’ was ambiguous; to some it might imply that Melanoma UK was involved in the development/creation of the material which was not so. Novartis’ agreement with Melanoma UK stated that Melanoma UK would be named as a campaign partner on the materials and would make the materials available on its website. In the Panel’s view it was particularly important that company materials on a patient organisation’s website accurately stated the role and input of each party. On balance the Panel considered that the description of each party’s role in relation to the material, particularly the use of ‘in association with’, was ambiguous and thereby misleading such that the role of the company was unclear; a breach of the Code was ruled.