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AUTH/2978/9/17 - Anonymous consultant dermatologist v Janssen

Case number:AUTH/2978/9/17
Case ref:Anonymous consultant dermatologist v Janssen
Description:Alleged Promotion of Tremfya
Breach:Breaches Clauses 2, 3.1 and 9.1
Appeal:Appeal by respondent
Status:Appeal by respondent
Review:Published in the May Review 2018
Case Summary:

​An anonymous, non-contactable consultant dermatologist complained about a Janssen symposium entitled ‘Emerging Treatments for Psoriasis: Unlocking the IL-23 Pathway’. The symposium was part of the British Association of Dermatologists’ (BAD) annual meeting held in Liverpool, July 2017. 

The flyer for the symposium referred to emerging treatments for psoriasis and that the meeting would provide an opportunity for focussing on the pivotal role of IL-23. The similarities and differences in the mechanism of action of therapies which targeted this cytokine and the latest data for guselkumab and other IL-23 targeting molecules would be presented. The flyer stated at the bottom, in small blue font, that guselkumab was not licensed in the UK. 

The complainant provided a copy of the flyer for the ‘so called’ symposium which he/she had been given at the Janssen exhibition stand. The complainant stated that although the symposium was entitled ‘Emerging Treatments for Psoriasis: Unlocking the IL-23 Pathway’, it was obviously a presentation about guselkumab (Tremfya) as the weight of discussion and evidence presented related mainly to that product. The complainant was surprised to see prescribing information at the end of the presentation. At the time, guselkumab was not licensed anywhere in the world and although the meeting appeared to be a ‘scientific’ symposium, it appeared to actually be mainly about guselkumab. The complainant alleged that it was unacceptable to discuss a medicine which was not licensed in that way. 

The detailed response from Janssen appears below. 

The Panel noted that promotion was defined as any activity undertaken by a pharmaceutical company or with its authority which promoted the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines. The Panel noted that although the Code prohibited the promotion of a medicine prior to the grant of its marketing authorization, certain activities with regard to unlicensed medicines were permitted such as the legitimate exchange of medical and scientific information during the development of a medicine provided that this did not constitute promotion which was prohibited. 

The legitimate exchange of scientific information during the development of a medicine should involve debate that enhanced the current state of knowledge. To avoid being seen as promotional, it should not be a one way flow of information. 

The Panel noted that the symposium started at 18:15 and consisted of two presentations on ‘Leveraging IL-23 in psoriasis’ and ‘What next for IL-23 inhibition?’ (from 18:20 until 18:50). Ten minutes were then set aside for Q&A and discussion and the seminar finished at 19:00. The Panel queried whether the agenda allowed for ‘the exchange of information’ given the very limited time for discussion and input from the audience. 

The Panel noted that the first presentation (20 minutes) had a title slide of ‘Selective blockade of IL-23 in psoriasis – A novel treatment concept’. Half of the 34 slides looked at selective IL-23 inhibition; risankizumab clinical trials featured on one slide, clinical trial results for tildrakizumab were discussed on 5 slides and data from guselkumab trials were on 8 slides. 

The second presentation was entitled ‘What next for IL-23 inhibition?’; the certificate for the material, however, described the item as ‘Slide deck for 10 minute presentation titled ‘What next for guselkumab?’. Focussing on how it could change clinical practice, what it would mean for patients and what trials are … [the text then became unreadable]’. Of the 19 slides, 12 were specifically about guselkumab clinical trials. The Panel noted the original title for the presentation had been changed. It queried whether such a product-specific slide deck would have been written by the speaker. 

The second presentation included prescribing information for Stelara which was referred to in the briefing notes as IL-12/23 so it appeared that there was a promotional element to the symposium. 

The Panel noted that the purpose of the symposium set out in the briefing document for speakers did not mention the exchange of information and there was very limited time for such. 

The evaluation form asked attendees to assess the session in terms of overall interest, fulfilment of learning objectives and to rate ‘the relevance of the content i.e. could it change your clinical practice?’. The evaluation form also invited attendees to ask for ‘further information on the topics discussed during this meeting’. In that regard, Janssen appeared to be soliciting questions about its unlicensed medicine. 

It appeared that the Janssen booth included a commercial section and medical information staff would be present at certain times to provide assistance on a number of issues including off-label indications/uses, pipeline products and investigator initiated studies (IIS). 

In the Panel’s view, it was reasonable to assume that, on the balance of probabilities, many of the booth visitors would ask about guselkumab. The briefing materials prepared staff for such questions and medical information staff were there to answer such questions. 

The Panel considered that the symposium in July 2017 focussed on Janssen’s product which was authorized by the FDA on 13 July. Although the term ‘investigational’ was not defined, the Panel queried whether a product for which a marketing authorization was applied for in the US and received just over a week after the symposium and was going through the EMEA process for a marketing authorization could be considered to be an ‘investigational molecule’ or being ‘in development’. In the Panel’s view, health professionals were likely to view guselkumab as a pre-licence product. 

The Panel did not consider that the arrangements for the symposium would lead to an exchange of information. The limited time for discussion together with the balance of information presented being about Janssen’s new product which would be likely to receive a marketing authorization within a few months meant that the medicine had been promoted prior to the grant of its marketing authorisation. A breach of the Code was ruled.

The Panel ruled a breach as high standards had not been maintained. Promotion of an unlicensed medicine brought discredit upon and reduced confidence in the pharmaceutical industry so a breach of Clause 2 was also ruled. 

On appeal by Janssen of all of the Panel’s rulings of breaches of the Code, the Appeal Board noted that under the objectives’ the briefing for the speakers and chairman made no mention that discussion and an exchange of scientific information were essential; the stated objectives implied that data was being presented. 

The Appeal Board noted from the transcript of the meeting that there were only two questions from the audience despite encouragement from the chair. The Appeal Board considered this was surprising given the data and the potential impact of a different treatment approach. The Appeal Board considered that the company should have done much more to engage the audience and to stimulate debate to enable two-way discussion and an exchange of medical and scientific information. 

The Appeal Board considered that there was very little evidence of any legitimate scientific exchange. The Appeal Board did not consider whether the medicine was still in development; this had not been raised by the complainant. The Appeal Board considered that the balance of information presented in the second presentation was about Janssen’s new product which would be likely to receive a marketing authorization within a few months and that this in conjunction with the points mentioned above meant that the medicine had been promoted prior to the grant of its marketing authorisation. The Appeal Board upheld the Panel’s ruling of a breaches of the Code including Clause 2. The appeals on all points were unsuccessful.