AUTH/2029/7/07 and AUTH/2030/7/07 - Clinical Director v Bristol-Myers Squibb and Sanofi-Aventis

Sponsorship of a meeting

  • Received
    02 August 2007
  • Case number
    AUTH/2029/7/07and AUTH/2030/7/07
  • Applicable Code year
    2006
  • Completed
    25 September 2007
  • Breach Clause(s)
    9.1
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the November 2007 Review

Case Summary

The Myocardial Infarction National Audit Project (MINAP) complained about the activities of an agency working on behalf of Sanofi-Aventis and Bristol-Myers Squibb and, in particular, an invitation to a meeting.

The complainant noted that MINAP collected and analysed data on acute myocardial infarction from all acute hospitals in England and Wales. It had existed since 2000 and was now one of the world's largest audits of myocardial infarction. It was funded by the Healthcare Commission. Involvement with MINAP was mandatory for acute hospitals and MINAP analyses were used to measure hospital performance and as evidence of collaboration in national audit by the Healthcare Commission.

MINAP had a strong presence within the cardiac community and was widely recognised as a very successful long term national project which had resulted in major improvements in cardiac care. It was highly respected as a source of national data on care for acute myocardial infarction. MINAP had never solicited support from industry; it was the view of the MINAP steering group that MINAP should have no involvement with the pharmaceutical industry.

The complainant stated that in summer 2006 a member of the MINAP steering group told him about a local collaboration in which she and a colleague, together with Bristol-Myers Squibb, would develop a toolkit to assist local hospitals make the best use of MINAP data. The complainant understood that the cost was to be funded by an unrestricted educational grant from Bristol-Myers Squibb.

The complainant stated that on presenting this work to the MINAP steering group his colleague had been advised to proceed with great caution with any involvement with industry, and that MINAP itself would not become directly involved. Nevertheless, on the basis that Bristol-Myers Squibb would support the development of the toolkit the complainant met the agency which was involved in developing the toolkit on behalf of Bristol-Myers Squibb, in order to hear more of its proposals. This consisted of developing the toolkit – on the basis of ideas provided locally – and presenting this work at a series of seminars involving clinicians, nurses, audit staff, and cardiac network staff throughout the country. It was stated by the agency that funding was unrestricted. After the meeting those involved with the project had misgivings about the direction inwhich it was moving, and in particular it became clear that support was not unrestricted and that they were going to be working on an enterprise which had clear commercial involvement and which would involve promotion, either directly or indirectly, of relevant pharmaceutical products.

As MINAP was a national project funded by the Healthcare Commission it was clearly impossible for it to be involved with such commercial enterprise, and the complainant advised the agency accordingly and considered the matter closed. The complainant's colleagues also withdrew their involvement.

The complainant was surprised therefore to discover that the project had continued and developed into a one day meeting 'Getting the most of MINAP' and with promotional material clearly emphasising a link with the MINAP project. The complainant provided a two page document headed 'Best practice seminars in using MINAP to improve local cardiac care' as an example of the material involved which he alleged had linked the companies sponsoring the meeting with MINAP. The item included the sentence 'The workshop is based on a new toolkit of best practice developed in association with the MINAP Steering Committee and local stakeholders'. As far as the MINAP steering committee was concerned this was false. An association was being made with MINAP – a mainstream and well regarded national project – and the commercial activities of these companies. No association existed and the complainant repudiated any involvement with this project. In Module 3 of the meeting there was to be feedback for the MINAP steering committee. MINAP had never solicited any feedback, nor had it received any. MINAP did not want to be associated with these activities and objected to its name being used in association with meetings sponsored by these pharmaceutical companies.

The complainant was concerned that:

• MINAP's good name had been used to commercial advantage, without permission and against the wishes of the MINAP steering group;

• these activities might be considered a form of disguised promotion;

• any suggestion in the promotional literature that MINAP was involved with this project was knowingly false and misleading;

• this activity had an adverse impact on MINAP and its relations with the very wide group of individuals who supported it; MINAP had itsown agenda of information and advice that it wished to impart ie by means of regional visits, and this was being subverted by these meetings.

The Panel noted that the complaint was about a series of meetings sponsored by Sanofi-Aventis and Bristol-Myers Squibb entitled 'Getting the most out of MINAP' although the complainant focussed on the arrangements for one of those meetings. According to the companies the meetings were designed to facilitate improvements in the quality of patient care through the better use of the MINAP audit tool. The meeting content and tool kit was developed by the companies' agency. The Panel did not consider that the companies were prohibited in arranging meetings about MINAP but such meetings had to comply with the Code. It was an established principle that the companies were responsible under the Code for the activities of agencies or other parties acting on their behalf.

The Panel noted the parties' submissions about the development of the toolkit and meeting programme. All agreed that initially the MINAP steering committee and the agency had talked about the meeting programme but that MINAP had subsequently stated that it did not want to have any further involvement with it. Regional MINAP staff also withdrew from the project. The companies submitted that they then took corrective measures to ensure that their material did not reflect an association with MINAP. However due to an error an old invitation was sent by the companies' agency to the meetings administrator who in turn sent it to invitees.

The invitation provided by the complainant was entitled 'Best practice seminars in using MINAP to improve local cardiac care. Getting the most out of MINAP'. A highlighted box, above the agenda, explained that the toolkit of best practice was developed in association with the MINAP steering committee and local MINAP stakeholders. 'Module 3: MINAP in practice' listed as its final bullet point 'Feedback for MINAP steering group'. The Panel considered that the invitation gave a misleading impression of the positive involvement of the MINAP steering committee and suggested that the toolkit was endorsed or otherwise approved by it. The Panel noted that whilst, at the request of MINAP, delegates were told at the outset of each meeting that the programme was not associated with the MINAP steering committee this was not sufficient to correct the otherwise misleading impression given by the invitation. The misleading impression was compounded by the wording of the declaration of sponsorship which explained that 'The toolkit development and workshop is sponsored by Bristol- Myers Squibb Pharmaceuticals Ltd and Sanofi- Aventis'. This implied that the companies' role was limited to financial support which was not so. The meetings and toolkit were in effect developed by the companies, via their agency in consultation with others. High standards had not been maintained. A breach of the Code was ruled. The Panel did not consider that the invitation brought discredit uponand reduced confidence in the pharmaceutical industry.

The Panel noted that in subsequent invitations the reference to the role of MINAP and feedback had been removed. The Panel noted the agenda consisted of three modules: MINAP in the NHS, achieving the benefits and MINAP in practice. Copies of the presentations were provided and these discussed MINAP data under the module headings. There was no product specific material nor were there any exhibition stands at the meetings. The Panel considered that there was no evidence before it to indicate that the meetings were promotional and disguised in this regard. High standards had been maintained and no breach of the Code was ruled.