AUTH/3213/6/19 - Anonymous v Janssen

Alleged off-licence promotion

  • Received
    20 June 2019
  • Case number
  • Applicable Code year
  • Completed
    10 June 2020
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, non-contactable complainant raised concerns about off-licence promotion which he/she alleged took place at a Janssen sponsored oncology meeting, held in March 2019.

Janssen marketed Zytiga (abiraterone) and Erleada (apalutamide) for use in the treatment of prostate cancer.

The complainant alleged that an external speaker who acted on behalf of Janssen, discussed ‘off-licence’ castrate resistant prostate cancer treatment. The complainant considered that the information was misleading and indirectly promotional and was therefore not appropriate for the meeting at issue which was advertised as a medical educational event. The content contained at least 7-10 slides of unlicensed information which was disseminated to a wide UK audience as well as broadcast via a webinar. The complainant stated that he/she felt misled and let down by this event.

The detailed response from Janssen is given below.

The Panel noted that the complainant was anonymous and non-contactable. The Constitution and Procedure stated that anonymous complaints would be accepted, but that like all other complaints, the complainant had the burden of proving his/her complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties. The complainant could not be contacted for further information.

The Panel noted Janssen’s submission that in the absence of more specific information it referred to the agenda for the live streamed component of the meeting and noted that two sessions in the morning addressed castrate resistant prostate cancer (CRPC): Treatment decisions for CRPC; and Optimising treatment for patients with metastatic CRPC. Janssen had reviewed the presentations in these sessions and could not identify any information on its medicines that would support the allegation of off-licence promotion.

The Panel noted that the complainant referred to the 7-10 slides in question being shown on the afternoon of 2 March. The Panel considered that whilst Janssen stated that the afternoon had not been live streamed its content still fell within the scope of the complaint.

The Panel noted that the afternoon session comprised a series of sessions and interactive case studies in breakout groups. The Panel noted that the slides referred to Janssen’s products but noted Janssen’s submission that none constituted off licence promotion. In particular, the Panel noted Janssen’s submission that the reference to a new generation anti-androgen, referred to in case study 2, was applicable to its product Erleada which was approved 4 weeks before the meeting.

The Panel noted that the complainant had not made clear which slides and statements were the subject matter of his/her concerns nor detailed why in his/her view such statements were in breach of the Code. It was not for the Panel to infer detailed reasons to support the allegation on behalf of the complainant. It was for the complainant to establish his/her case on the balance of probabilities. In the Panel’s view, the complainant had not been sufficiently clear about the subject matter of the complaint and thus had not discharged his/her burden of proof to show that a breach of the Code had occurred and the Panel therefore ruled no breach of the Code.

The Panel noted that promotional material did not need to be labelled as such, however, it must not be disguised, and the identity of the responsible pharmaceutical company or a pharmaceutical company’s involvement must be obvious at the outset.

The Panel noted that both the front and second page of the ‘Save the Date’ flyer, and the hard copy and online agenda stated that the meeting was initiated and funded by Janssen and that an independent faculty had determined the structure and scientific content of the meeting, albeit in small font in a footnote at the bottom of each page. The Panel noted that, in addition, both the front and second page of the ‘Save the Date’ flyer and the hard copy and online agenda included a Oncology Medical Education logo and a Janssen Oncology logo in the bottom left and right hand corners respectively. The flyer asked invitees to contact a Janssen medical manager for more information. The Panel also noted that the third slide of the ‘Welcome and Introduction’ presentation included a prominent Janssen Oncology logo and the previous slide included the declaration described above prominently displayed above the Janssen Oncology logo. The Panel noted Janssen’s submission that delegates would expect the latest data to be discussed and as it was clearly a Janssen organised meeting it would be unreasonable to expect that Janssen products would not feature where appropriate in the context of educational talks. According to Janssen, where relevant, speakers included appropriate, accurate, balanced, objective and current information on Janssen and competitor products. In these circumstances and given Janssen’s role in the meeting, its commercial interest, and the broad definition of promotion set out in the Code the Panel queried whether such a meeting could be considered as anything other than promotional. The Code required such meetings to include educational content.

The Panel noting its comments above and Janssen’s involvement as set out at the outset on the ‘Save the Date’ flyer, agendas and the ‘Welcome and Introduction’ presentation did not consider that those invited would have expected anything other than a promotional meeting. The Panel queried whether information about Janssen’s role should have appeared on all of the presentations however, on balance, considered that the promotional nature of the meeting was not disguised in the manner alleged by the complainant and ruled no breaches of the Code.

The Panel considered that the particular circumstances of this case did not warrant a ruling of a breach of Clause 2 of the Code which was a sign of particular censure and reserved for such use. No breach of Clause 2 was ruled.