AUTH/2781/7/15 - AbbVie v Bristol-Myers Squibb

Alleged off licence promotion disguised as a medical symposium

  • Received
    09 July 2015
  • Case number
    AUTH/2781/7/15
  • Applicable Code year
    2015
  • Completed
    06 October 2015
  • No breach Clause(s)
    2, 4.1, 3.2, 4.10, 9.1 and 12.1.
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2015

Case Summary

​​AbbVie alleged that a medical symposium at the British Society of Rheumatology (BSR) 2015, sponsored by Bristol-Myers Squibb, was promotional and encouraged the use of abatacept (Orencia) which was inconsistent with its marketing authorization. 

Orencia, in combination with methotrexate (MTX), was indicated for the treatment of moderate-tosevere active rheumatoid arthritis (RA) in adults who had responded inadequately to previous therapy with one or more disease-modifying antirheumatic drugs. 

AbbVie alleged that although the symposium was presented as being medically led, it was a promotional event in that: it was sponsored by Bristol-Myers Squibb; no new scientific data was presented; abatacept was proactively and prominently discussed and its benefits were emphasised and there were several presentations during the 90 minute symposium, which did not allow for significant two-way exchange with the approximately 100 strong audience. 

AbbVie further alleged that the symposium encouraged the use of abatacept inconsistent with its marketing authorization, for example in undifferentiated inflammatory arthritis. Interactive patient case studies used a poll to measure the change in the audience's intention to prescribe with an unlicensed dose.

AbbVie alleged the content of the symposium went beyond what was acceptable for legitimate scientific exchange.

The detailed response from Bristol-Myers Squibb is given below. 

The Panel noted that pharmaceutical companies could sponsor symposia at third party meetings. The symposium in question had clearly been characterised as 'A Bristol-Myers Squibb Medical Symposium'; potential attendees would know that it was a pharmaceutical company sponsored event. The material used to advertise the symposium did not include any direct or indirect reference to Orencia. The Panel further noted that the BSR organising committee considered that the symposium topic 'Rheumatoid Arthritis: Is There a Path to Drug- Free Remission' was suitable for discussion at its conference and had included the event in its conference programme and advertised it as such. Invitations had only been distributed in delegate bags of registered attendees. The symposium had not been advertised on a promotional stand and members of Bristol Myers-Squibb's sales force who had attended the conference had been instructed not to discuss the symposium with delegates or invite/directthem to attend. Bristol-Myers Squibb appeared to have no control over who attended the symposium. The Panel noted Bristol-Myers Squibb's submission that the symposium discussed, inter alia, new trials which would potentially advance the understanding of the immunological basis of rheumatoid arthritis. The Panel further noted that Bristol-Myers Squibb had emphasised that only its medical department had been involved in organising, reviewing, approving or funding the arrangements and/or materials for the symposium and that there was no commercial input. In that regard the Panel noted that it was immaterial as to which department organised, reviewed, approved or funded the event; it was the content and arrangements which determined whether it was promotional or could be considered the legitimate exchange of medical and scientific information. 

The Panel noted that the symposium, which lasted 90 minutes, consisted of three presentations. The programme allowed half an hour for questions and answers and throughout the presentations delegates could use mobile devices to send comments/questions directly to the faculty and speakers. This was in contrast to AbbVie's submission that there were several presentations which did not allow for significant two way exchange with the audience. Feedback from the symposium indicated a high level of audience satisfaction with regard to the discussion session and the opportunity to ask questions. 

The first presentation was entitled 'The “at-risk” individual – definition and prospects for therapy'. The presentation included information about APIPPRA and AARIA, investigator initiated abatacept studies. The APIPPRA study set out to investigate Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept and the AARIA study set out to see if abatacept could prevent inflammatory lesions in at-risk patients. Neither use of abatacept was licensed. One of the slides detailing the APIPPRA study was headed 'Why should we try abatacept?' and in this regard the Panel noted Bristol Myers Squibb's submission that the slide set out the rationale for investigating abatacept in the prevention of rheumatoid arthritis. In the Panel's view it was possible that the audience might translate the heading to mean 'Why should I try abatacept [for disease prevention]?', however it was clearly stated in one slide that the APIPPRA study was now recruiting across the UK and the Netherlands. Two of the speaker's earlier slides referred to the PRAIRI study (also an investigator initiated study) which explored disease prevention with rituximab. The Panel noted, that Bristol-Myers Squibb described preventative rheumatoid arthritis studies as new and ground breaking. The first speaker's summary slide stated that clinical trials to date had not identified an intervention proven to delay or prevent the onset of clinically apparent synovitis and that exploration of the impact of targeted therapies in the at-risk population was still ongoing. In the Panel's view this slide summarised the direction that current research was taking but neither the summary slide nor the presentation was likely to encourage delegates to use Orencia in atrisk patients to prevent rheumatoid arthritis. 

The second presentation was entitled 'Biomarkers – a road map for individualized treatment?'. Only six of the 49 slides variously referred to abatacept; many of the other slides referred to other medicines such as methotrexate, rituximab, and tocilizumab. The concluding statement read 'Individualized medicine approaches are anticipated to transform future management of [rheumatoid arthritis] – but we're not there yet!' 

The final presentation, entitled 'Early treatment – is this the pathway to drug-free remission?', presented some case studies including audience polls and discussed, inter alia, the withdrawal or de-escalation of abatacept. Other medicines were also discussed. 

Overall, the Panel considered that the presentations stimulated new ways of thinking with regard to treating and or preventing rheumatoid arthritis. Two of the three current studies examining prevention used abatacept (APIPPRA and AARIA) however the Panel did not consider that the tone or content of the presentations would encourage the audience to use abatacept outside its marketing authorization for disease prevention. The Panel did not consider that the presentations emphasised the benefits of abatacept as alleged; in its view there was no greater prominence given to abatacept than any other medicine. 

Overall, the Panel did not consider that AbbVie had, on the balance of probabilities, proven its complaint that the symposium constituted the disguised promotion of abatacept for an unlicensed indication. No breaches of the Code were ruled. Given its view that the symposium did not constitute the promotion of abatacept, the Panel did not consider that delegates needed to be given the prescribing information or the statement regarding reporting adverse events. No breaches of the Code were ruled. 

The Panel noted its rulings above and considered that there was no evidence that high standards had not been maintained. No breach of Code was ruled. Given its rulings of no breach of the Code, the Panel consequently ruled no breach of Clause 2.​