AUTH/2540/11/12 and AUTH/2545/11/12

Promotional meeting allegedly disguised as education

  • Received
    13 November 2012
  • Case number
    AUTH/2540/11/12 and AUTH/2545/11/12
  • Applicable Code year
    2012
  • Completed
    20 December 2012
  • No breach Clause(s)
    9.1, 12.1, 19.1 and 19.3
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    February 2013

Case Summary

​A non-contactable clinician complained anonymously about a meeting held jointly by Lilly and Boehringer Ingelheim. The companies jointly marketed Trajenta (linagliptin), a dipeptidyl peptidase 4 (DPP-4) inhibitor for the management of type 2 diabetes and Jentadueto (linagliptin and metformin) also for the management of type 2 diabetes.

Lilly also marketed Byetta (exenatide), a glucagon-like peptide-1 (GLP-1) receptor agonist for the management of types 1 and 2 diabetes. The complainant stated that some years ago he/she had stopped meeting representatives because of their behaviour and the swollen numbers who sold the same medicine.

The complainant stated that Lilly's meeting was advertised as a means of understanding how the new diabetes medicines fitted into patient care. As a lead on diabetes the complainant thought this would be useful and probably in keeping with the meetings other companies had offered locally. However, despite the assurance of genuine medical education, the meeting overtly promoted Trajenta and Byetta. The speakers were little other than paid sales people for Lilly and the questionnaire asked which particular DPP-4 inhibitor the reader currently used and if the meeting had changed that choice. The complainant submitted that this clearly indicated that this was a sales meeting disguised as genuine education. As the meeting ended, the representatives poured into the meeting room and handed out prescribing information. The complainant understood that this was illegal.

The detailed responses from Lilly and Boehringer Ingelheim are given below.

 The Panel noted that the complainant was anonymous and non-contactable. Such complaints were accepted and like all complaints judged on the evidence provided by the parties. The complainant had the burden of proving his/her complaint on the balance of probabilities.

The Panel did not know how the complainant had found out about the meeting. A journal advertisement which promoted the meeting was entitled 'Complexity of type 2 diabetes. A hands-on guide to simplify care in clinical practice'. A prominent highlighted box featured the sponsoring companies' logos and the explanation that 'These meetings have been developed by [the publisher of a diabetes journal] in conjunction with, and sponsored by, Boehringer Ingelheim Ltd and Eli Lilly and Company Limited'. In a separate highlighted box to the right were the logos for the journal and its publisher. Beneath the two boxes, in a prominent white typeface, the reader was told where to findprescribing information for linagliptin. The advertisement gave brief details of the programme committee and a short introduction alongside their photographs stated 'We have designed this series of complimentary meetings …' and 'We look forward to welcoming you …' although it was unclear who 'we' were. The invitation detailed the agenda for the halfday meeting which began at 12 noon with lunch and registration. Three presentations, 'All change! What you need to know about diagnosing type 2 diabetes now', 'Understanding the spectrum of different glucose-lowering drugs available', 'Understanding the relationship between diabetes, glucose-lowering drugs and cardiovascular disease' and 'Requirements after prescribing: what to monitor, when and why?' were followed by an 'Ask the experts session'. The meeting concluded at 4:45pm. The other invitation formats were closely similar in content although the layout differed; an email invitation provided a less detailed account of the agenda. All featured the prominent description of the companies' involvement and, all apart from a flyer, had a link to prescribing information. The Panel was concerned that the flyer did not contain prescribing information. All material had to be capable of standing alone in relation to Code compliance. There was no allegation in relation to the absence of prescribing information. The Panel noted that the prominent highlighted box describing the companies' involvement as 'in conjunction with, and sponsored by' appeared on pages 1, 2 and 4 of the four page flyer. The Panel considered it would have been helpful if more information about the status of the programme committee had been given and in that regard had some sympathy with the complainant. However, overall, the Panel considered that from the description of the companies' involvement, 'in conjunction with, and sponsored by', it was sufficiently clear that they did not have an arm's length arrangement with the publisher and that the companies' involvement went beyond the provision of finance. The average invitee would reasonably expect the agenda to discuss, inter alia, the companies' products and thus be categorized under the Code as promotional in this regard.

The Panel noted that it was also possible that the complainant had been invited by postal invitation or telephone. There was no way of knowing whether this was so and precisely what had transpired. The Panel noted that whilst representatives had delivered invitations, the complainant had stated that he/she had stopped meeting representatives some years ago.

The Panel noted that all meetings had to comply, inter alia, with the Code and have a clear educational content. The Panel noted that each presentation was accompanied by speaker notes.The Chair's introductory presentation discussed the complexity of the current prescribing environment including cost. The first presentation discussed diagnosis including detailed case scenarios. The second presentation 'Understanding the spectrum of different glucose-lowering drugs available' outlined the advantages and disadvantages and discussed each class of medicine; linagliptin and exenatide were referred to. The presentation concluded with a discussion of published guidance on the management of hyperglycaemia (NICE, QUIPP etc); one of the take-home messages was 'However, the choice of agent depends on the specific circumstances and needs of the person with type 2 diabetes'. The third presentation, which discussed the relationship between diabetes, glucose-lowering drugs and cardiovascular (CV) disease, summarized CV outcomes of the major clinical trials. Cardiovascular outcome data for inter alia, exenatide and linagliptin were discussed. The final presentation discussed renal function monitoring and referred to medicines across all classes in relation to renal impairment. One slide favourably compared the clinical characteristics (dose adjustment, monitoring etc) of linagliptin with other DPP-4 inhibitors.

The Panel noted that speakers were briefed that, in addition to examining the key complexities of type 2 diabetes in clinical practice, the meetings aimed to provide information on the role of linagliptin and specifically in potentially reducing the management complexity of this condition. The Panel considered that such an aim was not necessarily unacceptable so long as the meetings and advertisements about them complied with the Code. The Panel noted its comments above about the impression given by the invitation. The Panel also noted that the detailed speakers' briefing in relation to the individual presentations appeared balanced and only mentioned linagliptin once.

The Panel noted the clear educational content of the meeting as set out above and ruled no breach of the Code. The Panel noted its comments above about the role of the companies, the publisher and the programme committee as set out in the invitations. The requirement in the Code about declarations and meetings related solely to sponsorship and in that regard the Panel considered that the companies' sponsorship had been disclosed on the invitations and on the slides; no breach of the Code was ruled.

It was not necessarily unacceptable for a questionnaire to enquire about a delegate's current and future prescribing decisions so long as it complied with the Code. Delegates did not have to provide the information. The Panel also noted that contrary to the complainant's account, the companies submitted that no representatives had entered the meeting room. It was not possible to determine where the truth lay. Whilst the parties' accounts differed, the Panel noted that it was not necessarily unacceptable for representatives to enter the main meeting room in relation to the meeting at issue.

The Panel noted that it had no way of knowing what was actually said by the speakers at the meeting in question. The Panel considered that the meeting was promotional for the companies' products mentioned. However, bearing in mind the impression given by the invitations as outlined above the Panel did not consider that its promotional nature was disguised as alleged; no breach of the Code was ruled. The Panel also ruled no breach of the Code in relation to maintenance of high standards.