AUTH/3311/2/20 - Complainant v Leo

Media Advisory Board for Kyntheum

  • Received
    18 February 2020
  • Case number
  • Applicable Code year
  • Completed
    25 February 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, non-contactable individual complained about a media advisory board for Kyntheum (brodalumab) held by Leo Pharma Laboratories Ltd. Kyntheum was indicated for the treatment of moderate to severe plaque psoriasis in adults who were candidates for systemic therapy.

The complainant provided a copy of a report published by the Medicines and Healthcare Products Regulatory Agency (MHRA) about its investigation into the media advisory board in question.

The report stated that nine UK-based journalists attended a media advisory board organised by Leo in June 2017 where they were paid to advise Leo on securing media interest on psoriasis, its effect on patients and on Leo’s approach to disseminating newsworthy information on Kyntheum. The agenda included a presentation which featured significant content describing the benefits of Kyntheum which was yet to receive a marketing authorisation and the MHRA considered that the advisory board was designed to promote an unlicensed medicine to the attendees. Leo agreed to issue a corrective statement to attendees, at the request of the MHRA.

The complainant stated, referring to the MHRA report, that he/she did not believe that the matter had been assessed under the Code and requested that the PMCPA do so.

The detailed response from Leo Pharma is given below.

The Panel noted that this would be the fourth time the apparently same matter was raised with a regulatory body. The Panel noted that it had to consider all complaints in accordance with its Constitution and Procedure and thus it had to consider and rule upon matters referred to it. The Panel noted that this was the first time however that the matters had been considered in relation to the requirements of the Code.
The Panel first had to decide whether the advisory board was promotional. The Panel considered that it was acceptable to hold advisory boards for journalists so long as the overall arrangements complied with the Code. In this regard particular care had to be taken to ensure that the overall arrangements and content were appropriate for journalists. The status of the journalists, whether they were also health professionals, and whether they worked for consumer or health care professional publications would be relevant.

The Panel noted the business questions which the company stated that it needed to address and queried whether those which covered general psoriasis matters (What aspects of new medical/scientific information on psoriasis treatments were most newsworthy and how to communicate on psoriasis and its complications within a media environment which more commonly covered other chronic diseases) were bona fide business requirements given Leo’s long- standing heritage in this area. In the Panel’s view, given the limited information before it, those business questions about brodalumab did not appear to be unreasonable requirements for the business.

The Panel did not accept Leo’s submission that delegates were among a limited community of media experts experienced in reporting on a range of health issues within the national consumer press and it was on this basis that each was chosen. The Panel noted that according to the invitation Leo originally intended to invite health journalists from consumer and medical publications in the UK. This was echoed in other materials including the meeting agenda which referred to seeking advice from consumer, medical and trade journalists. The Panel noted that ultimately the advisory board participants were all freelance journalists, one of whom was a doctor and one of whom was also an agony aunt. All appeared to contribute primarily to consumer media. The Panel queried whether Leo could therefore be sufficiently confident that the majority of the participants had the requisite expertise to address the business questions insofar as they related to medical and trade publications. In this regard, the Panel noted from the executive summary of the meeting that it appeared to cover matters primarily related to the consumer press. This disparity was also echoed in the relatively fewer comments participants made in relation to trade and medical press as recorded in the meeting report. The Panel also queried whether the number of delegates with consumer media expertise was appropriate given the breadth of advice sought covered medical, trade and consumer press.

The Panel noted the detailed scientific presentation about brodalumab which comprised 16 slides covering its mechanism of action and the clinical trial programme. The Panel noted Leo’s view that a summary about brodalumab would enable participants to provide better quality counsel. The Panel queried whether the detail was appropriate for participants advising in relation to the consumer press. The Panel noted that speaker notes from the presentation stated that ‘There are current studies investigating brodalumab’s potential in treating psoriatic arthritis and so far results are positive. We expect to initiate a phase 3 study for this indication in Europe, but we do not wish to publish any timing on this yet’. The Panel queried whether this information was necessary in order for the attendees to be able to answer the required questions.

Taking all of the above circumstances into account the Panel considered, on balance, that the advisory board insofar as it concerned non health professional journalists writing for the consumer media did not satisfy the requirements for an advisory board and was thereby promotional.

The Panel noted that Kyntheum, was not classified as a prescription only medicine when the media advisory board at issue was held and thus on this very narrow technical point it ruled no breaches of the Code in this regard.

The Panel noted its comments above in relation to the promotional nature of the advisory board and considered that brodalumab had been promoted prior to the grant of its marketing authorisation and a breach of the Code was ruled.

The Panel ruled that high standards had not been maintained in breach of the Code.

In the Panel’s view the arrangements for the advisory board demonstrated a lack of care, and awareness of the Code on matters that reflected UK law. The Panel noted its comments above in relation to the consumer expertise of participants and that the participants had been paid to attend what the Panel considered to be a promotional meeting. The Panel noted that the supplementary information to Clause 2 included promotion prior to the grant of a marketing authorization as an example of an activity that was likely to be in breach of that clause. The Panel considered, on balance, that Leo had thus brought discredit upon, and reduced confidence in, the pharmaceutical industry and a breach of Clause 2 was ruled.