AUTH/3028/3/18 - Ex-Employee v AbbVie

Production of a poster and use of case studies

  • Received
    23 March 2018
  • Case number
    AUTH/3028/3/18
  • Applicable Code year
    2016
  • Completed
    17 October 2018
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Appeal by respondent
  • Review
    Published in the May 2019 Review

Case Summary

A contactable, ex-employee complained about the production of a poster by AbbVie and the use of case studies.  The poster in question related to Synagis (palivizumab) which was indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease.  The complainant had previously complained to AbbVie about the matter.

The complainant explained that the national team was tasked with finding a trust that would participate in the Embrace Stars poster submission.  The complainant joked with his/her line manger that the only way he/she would be able to achieve this after only a few months on territory would be to write a poster him/herself on behalf of a trust; he/she was shocked when the manager agreed.  The manager’s only concern was that the ideas suggested could not be ‘too commercially written’ but otherwise the manager fully agreed with the project and suggested multiple edits.  The complainant stated that he/she made it very clear he/she would never write a poster on behalf of registered clinical nurses again; it was uncomfortable and stressful.

The complainant explained that the submission was forwarded to the nurses to approve and then forwarded to the agency.  At one point the nurses told the agency that they did not recognise the work.

Eventually the poster was published and showcased around the country; ironically it was judged as ‘outstanding’ by the steering committee of nurse specialists.  The complainant considered that they would be disappointed if they knew that the poster was written by the company that funded the process.  To make matters worse, the statement ‘This poster has been reviewed for compliance purposes by AbbVie with no influence on the content/opinions being presented’ was printed on the bottom of the poster.  This was not so.  The poster was falsely portrayed as being written by health professionals and was written in such a way as to encourage health professionals to increase clinical capacity by up to 40%.  It was wholly unethical.  The conduct of the complainant’s manager to support such an activity was detrimental to AbbVie’s global reputation.  This action and conduct brought shame upon, and reduced confidence in, not only AbbVie, but the whole industry.

The complainant added that team members were asked to present case studies at regional Embrace meetings.  These case studies had not been put through the approval process and many in the team were extremely uncomfortable with the request as the case studies have been presented by health professionals or by AbbVie’s medical team.

The complainant noted that AbbVie partially upheld his/her complaint about the compliance issue and stated that it would take corrective action. The complainant considered that AbbVie had failed to properly investigate the poster submission; it had concluded that there was no breach of compliance.  The complainant suggested motives behind the company’s poor attempt at an investigation and also noted that the company had not referred to any contact with its communications agency to confirm or deny the suggestion that the nurses did not recognise the work – which would confirm that AbbVie was heavily involved in the writing of the health professional poster.

The complainant noted that AbbVie had partially upheld his/her complaint, however, he/she disputed this as he/she considered that AbbVie had failed to self-report this breach as required.  AbbVie had stated in its response that the claim of account managers presenting the case studies was unsubstantiated, however, the complainant stated that he/she had a photograph that was posted by his/her manager to a WhatsApp group, of a named account manager presenting the said case studies; this clearly substantiated the original grievance which demonstrated that AbbVie was clearly misleading in its response ‘unsubstantiated’.  Either AbbVie never investigated or deliberately tried to withhold information.

The complainant listed some of the issues he/ she had experienced with the internal complaints system and details were provided.

Subsequent to receipt of the complaint, the complainant provided additional evidence, a copy of a draft poster with track changes and comments which was provided to AbbVie.

The detailed response from AbbVie is given below.

The Panel noted that Case AUTH/2997/12/17 and Case AUTH/3028/3/18 contained similar allegations with regard to a named AbbVie representative presenting clinical case studies which had not been certified at a meeting in September 2017.  In Case AUTH/2997/12/17, the Panel ruled a breach of the Code as a Pathways document which consisted of three different scenarios (case studies), which were discussed in a session facilitated by an AbbVie representative, had not been certified, as acknowledged by AbbVie.  The Panel noted that the complainant bore the burden of proof and considered that there was no evidence to show that in facilitating a discussion on the three scenarios within the Pathways document, the representative in question, or the company, had failed to maintain high standards on this narrow point.  No breach of the Code was ruled.  The Panel noted that it was not necessarily unacceptable under the Code for a representative to present case studies, as alleged, provided that the manner in which it was done complied with the Code.

Turning to the current case, Case AUTH/3028/3/18, the Panel noted the complainant’s allegations regarding non-medical employees presenting uncertified case studies at regional Embrace meetings.  The Panel noted that the complainant had referred broadly to all regional Embrace meetings and had only subsequently referred to the meeting at issue in Case AUTH/2997/12/17 as an example of a relevant meeting when commenting on AbbVie’s findings during his/ her grievance proceedings.  The Panel considered that the rulings in Case AUTH/2997/12/17 set out above were relevant.  The Panel similarly ruled a breach of the Code in the present case in relation to AbbVie’s failure to certify the Pathways document (case studies) and no breach of the Code as the complainant in this case had not established that it was inappropriate for promotional staff to present case studies at promotional meetings as alleged.

The Panel noted that a further allegation in this case, Case AUTH/3028/3/18, concerned AbbVie’s involvement in the production of an Embrace Stars poster and its failure to accurately declare such involvement.  The poster at issue included the statement ‘This poster has been reviewed for compliance purposes by AbbVie with no influence on the content/opinions being presented’.  The Panel noted that the entry pack for the submission of the posters stated that the programme was organised and funded by AbbVie and would be certified as promotional material given that the posters were intended for display at a series of promotional educational meetings.  It also stated that AbbVie would have ownership of the posters created and would use the material promotionally subject to approval for the wider sharing of best practice in the field of RSV prevention.  The entry pack stated that AbbVie would provide support in developing posters through a communications agency.  In the Panel’s view, AbbVie’s role went beyond reviewing for compliance purposes as stated on the poster.  The role of its communications agency, whilst made clear to the participants at the outset and not necessarily unacceptable, went beyond matters of compliance and as shown by the track change comments on the completed template, at the very least influenced the content of the poster.  In addition, the Panel noted that the initial completed template submitted for the poster in question stated within the methodology section ‘working in conjunction with [named AbbVie representative] a simple spreadsheet was formulated to identify babies all year round …’.  In the Panel’s view, this supported the complainant’s assertion and it appeared that the named AbbVie representative was involved in the project that was the subject of the poster.  The Panel was concerned to note that the reference to the representative’s involvement did not appear on the published poster.

The Panel noted that whilst AbbVie’s involvement might have been clear to those submitting posters, the Panel did not consider that the declaration ‘This poster has been reviewed for compliance purposes by AbbVie with no influence on the content/ opinions being presented’ accurately reflected AbbVie’s involvement to readers.  In addition, the Panel considered that the prominence of the health professional authors’ names and pictures of the hospital compounded the misleading impression given by the declaration and a breach was ruled.

The Panel noted its comments above in relation to the failure of AbbVie to accurately reflect its involvement in the production of the poster.  High standards had not been maintained and a breach was ruled.

The Panel had some concerns about email communications between AbbVie staff and its communications agency and between the communications agency and the nurses said to be the authors of the poster, as well as concerns regarding AbbVie employees’ involvement with regards to the Embrace Stars poster at issue.  The Panel noted that the Code did not preclude the involvement of representatives in the creation of promotional material but companies should exercise caution in this regard.  The Panel noted its rulings of breaches of the Code including its concerns about the role of the AbbVie representative.  However, based on the narrow allegation, the Panel did not consider that the complainant had provided evidence to show that, on the balance of probabilities, the representative’s role, and/or influence, was such that it could be stated that the representative had created the poster or that it was created at the express request of his/her manager and that the representative had not applied high standards in this regard.  Based on the narrow allegation, the Panel ruled no breach of the Code.

Upon appeal by the complainant the Appeal Board considered that there was evidence to show that the complainant, the nurse(s) and AbbVie and its agency were involved with the production of the poster.  In that regard the Appeal Board noted the Panel’s ruling of a breach of the Code in relation to AbbVie’s declaration of its involvement in the production of the poster.  The Appeal Board considered that on the information available it did not have sufficient evidence to show on the balance of probabilities that the complainant had created the poster de novo at the direction of his/her manager, as alleged.  Consequently, on the narrow allegation, the Appeal Board considered that there was no evidence that the representative had not applied high standards in this regard.  The Appeal Board upheld the Panel’s ruling of no breach of the Code.  The appeal on this point was unsuccessful.

The Panel noted its comments and rulings above and did not consider that the circumstances warranted a ruling of a breach of Clause 2 which was as a sign of particular censure and reserved for such use.  No breach of Clause 2 was ruled which was upheld on appeal.