AUTH/2290/12/09 - Anonymous Clinician v Astellas

Mycamine advisory board

  • Received
    21 December 2009
  • Case number
    AUTH/2290/12/09
  • Applicable Code year
    2008
  • Completed
    16 March 2010
  • Breach Clause(s)
    2, 9.1, 12.1, 18.1 and 20
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    No appeal
  • Review
    May 2010

Case Summary

An anonymous and uncontactable 'concerned' hospital clinician complained on behalf of himself and his colleagues about a Mycamine (micafungin) advisory board conducted by Astellas Pharma.

The complainant noted that he was invited to a series of advisory boards in June/July 2009 which he believed were held all over the country. He attended one of these meetings in good faith. The complainant had no particular issue with the agenda on the day but got the feeling that he was being promoted to, more than having his advice sought. It was not entirely fair to say that the whole advisory board was promotional though he thought it had too many presentations.

The complainant noted that after the meeting a member of the Astellas team visited him. The complainant glimpsed a document with his name on it and those of a few other clinicians who had attended the meeting. He insisted on viewing it. Much to his distaste, there was clear detailing of various attendees and what they thought about Mycamine. It further analysed and detailed who should be promoted to and whose opinion had been changed by the advisory board with regard to prescribing Mycamine. The complainant wondered whether the entire point of the advisory board was to promote Mycamine.

The Astellas employee refused to give the complainant a copy of the document. He was taken into 'confidence' and pleaded with not to take this further. The employee told the complainant that Astellas had asked an agency to draw up the document but there had been an issue at the Astellas head office. The employee had stated that a medical manager had lost her job because she had not wanted the document to be distributed but the medical director had agreed to the document being distributed and so the employee did not feel that he was doing anything wrong. The complainant was shocked at the unethical behaviour of the company and he and his colleagues were annoyed that such information about consultants was compiled and distributed. They attended advisory boards to give an expert opinion with the hope that the information was used in a productive manner, not to have detailed profiles on themselves drawn up and distributed. Furthermore this advisory board was clearly intended to be promotional as the outcomes from it as noted in the document clearly detailed prescribing inclination before and after the advisory board.

The detailed submission from Astellas is given below.

The Panel noted that the advisory board programme consisted of three pairs of regional meetings with each meeting chaired by either by Astellas' previous interim medical director or the current medical director. The plan was for twelve advisors from each region to attend both meetings.

Each meeting began at 8.45am with tea and coffee and finished at 4.30pm. The agenda for the first meeting detailed six presentations of varying length totalling 5 hours; some of the presentations incorporated short group exercises. Round table introductions and feedback were each allocated 30 minutes. The rest of the agenda was taken up with refreshment breaks of 75 minutes. The agenda for the second meeting was similar to that of the first; again, some of the presentations included breakout or group exercises. However from the slides provided it appeared that much of the time at both meetings would be spent on presentations.

The invitation to participate in the advisory boards was signed by a senior brand manager. The letter stated that the company was seeking guidance and support in the future development and marketing of Mycamine; active participation was sought. £1,000 would be paid. The company wanted to understand local issues and work on better management solutions. The letter confirming engagement as an advisory board member stated that the recipient had been approached on the basis of their professional skills, expertise and knowledge of the therapeutic area, specifically candida infections. The letter set out the terms and, inter alia, asked participants to agree to the meetings being recorded and that material being used for the company's own business purposes. Participants also consented to use of their details in an internal database for business purpose use.

Advisors were selected for invitation largely on the basis of recommendation from key account managers (KAMs) and in that regard advice to the KAMs from the senior brand manager referred to the potential advisors as 'Mycamine advocates'. The KAMs were told that, inter alia, nominees had to have a belief in Mycamine, a sphere of influence including drugs and therapeutics, previous experience in getting drugs onto a formulary and a desire to work with Astellas and become a brand advocate. Brand advocacy was not referred to in the invitation to advisors nor in the letter confirming engagement. The email from the senior brand manager to the KAMs also referred to the importance of maintaining momentum if theuptake of Mycamine was to be increased through quarter 4 and beyond.

The Panel noted that the purpose of any advisory board meeting was for a company to collect health professionals' views and advice; it was not an opportunity to promote medicines. In that regard the Panel questioned the appropriateness of the advisors being nominated by members of the field force, supervised by the national sales manager. The agenda should allow adequate time for discussion and participation by all. The Panel queried whether that was so. The Code required that there must be a legitimate need for the services and the criteria for selecting consultants must be directly related to the identified need. The hiring of health professionals must not be an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.

The Panel was concerned that Astellas had used the pre-advisory board dinners as an opportunity for its medical and scientific liaison (MSL) staff to build relationships with the health professional attendees. It did not appear that participants were aware that their personal views would be provided to the MSLs and others to enable subsequent relationships to be built. The document setting out the views of participants was headed that the document was for MSL managers and not intended for use by sales representatives given that the content was obtained in an advisory board setting and it was not appropriate to take comments or recommendations and apply them in an alternative context.

MSL managers were advised that they could contact any advisory board member who had informally suggested another meeting or who had given them their business card; they were not to contact anyone who did not know them and when making contact MSLs were to develop relationships to expand their knowledge in the treatment area. MSLs were not to request visits to speak about Mycamine as this would make the visit promotional. Such visits should be carried out separately by the sales force.

The Panel was concerned about the role of the MSLs in that the Code defined a representative as anyone who called upon health professionals and/or administrative staff in relation to the promotion of medicines. Involving the MSLs in the advisory board meetings and follow-up meant that any subsequent discussion was not reactive ie not in response to a specific unsolicited enquiry and thus unable to take the benefit of the exemption to the definition of promotion as set out in the Code.

As part of the follow-up participants were asked by letter to discuss any further points with the KAMs who had been provided with details of the named individual participants' contributions and views relevant to the KAM's geographical area. This material appeared to be similar to that circulated to the MSL managers but without the headingstating, inter alia, that the material was not intended for use by sales representatives. Astellas had approved circulation of this material to the representatives and had considered that it did not need certification. A presentation had been prepared for the KAMs' internal use only. This had been certified. A spreadsheet setting out participants' views had also been circulated to the KAMs. Astellas had not approved circulation of this material to the representatives and it had not been certified. The Panel was very concerned at the nature and level of the detail provided to the KAMs. It did not consider that providing such reports to the sales force was consistent with the agreement that transcripts from the meetings could be used for Astellas' internal business purposes. The presentation and spreadsheet detailed feedback ranking ie from 0, limited use of echinocandins (caspofungin only); ignorant of Mycamine to 10, Mycamine on formulary; use of Mycamine; on message; willing to advocate to others. The data showed that compared to baseline the ranking had improved after the first advisory board and further gains had been made following the second meeting. The feedback ranking summary slide was headed 'Raise awareness and create motivation to support/prescribe Mycamine' and stated '93% positive shift of opinion towards Mycamine'. The Panel considered that the data produced as an outcome of the advisory board and shared with the sales force reinforced the impression that the purpose of the advisory board was, at least in part, to change the views of participants regarding Mycamine ie to promote the product rather than just elicit views and advice. The Panel acknowledged that any advisory board on a particular medicine would inevitably have some promotional impact on the participants. In the Panel's view, however, that such impact was evaluated and then communicated to the field force demonstrated an intention to promote Mycamine and positively change participants' views about the product.

The agenda and objectives as described to participants were not necessarily unacceptable. The selection criteria communicated to the KAMs, ie that the company expected advisory board members to inter alia, become brand advocates, was not an acceptable outcome for a genuine advisory board. The Panel considered that the provision of detailed information regarding advisory board members' position with regard to their personal use of Mycamine to the MSL managers and the KAMs (who promoted the medicine) was unacceptable as was the failure to certify briefing material for the representatives. The Panel also considered that the roles of the KAMs and MSLs before and after the meetings were inappropriate and inconsistent with the non-promotional purpose of an advisory board. In the Panel's view the overall arrangements for the advisory boards showed that they had, at least in part been held for a promotional purpose and to develop brand advocates/opinion leaders rather than solely for gathering expert advice and opinion.Thus the Panel ruled that the overall arrangements for the advisory boards were disguised promotion in breach of the Code. The payment of a fee to attend a promotional event was unacceptable and in effect an inducement to prescribe, administer or recommend a medicine. A breach of the Code was ruled.

The Panel considered that, given the overall arrangements for the advisory boards, Astellas had failed to comply with the requirements of relating to consultants. It was not a genuine consultancy arrangement given the discrepancy between internal and external documents and the involvement of the KAMs and MSLs. The Panel was also concerned that the hiring of the health professional might be in effect an inducement to prescribe, administer or recommend Mycamine. A breach of the Code was ruled.

The Panel considered that the overall arrangements had not maintained a high standard and thus a breach of the Code was ruled. With regard to Clause 2, the Panel noted that this was reserved for use as a particular sign of censure. The Panel considered that the overall arrangements, particularly the development of brand advocates under the guise of an advisory board, brought discredit upon and reduced confidence in the pharmaceutical industry and in that regard ruled a breach of the Code.