AUTH/2714/5/14 - Hospital consultant v Pfizer

Conduct of a representative

  • Received
    07 May 2014
  • Case number
    AUTH/2714/5/14
  • Applicable Code year
    2012
  • Completed
    07 November 2014
  • No breach Clause(s)
    2 and 8.2
  • Breach Clause(s)
    9.1 and 15.2
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Appeal by complainant
  • Review
    November 2014 Review

Case Summary

A consultant rheumatologist, complained about the conduct of a Pfizer medical representative and that of his/her manager.

The complainant explained that he/she had agreed to a 'ten minute catch up' with the representative and on the day the line manager accompanied the representative. The representative started by enquiring about the complainant's health as the previous year the complainant had been unwell. The complainant submitted that he/she found this extremely uncomfortable and inappropriate as he/ she did not really know the representative and believed they had only met briefly once before. The complainant considered that his/her health problems were a private issue and did not appreciate the representative discussing them, particularly in front of his/her line manager who the complainant had not spoken to before. In the complainant's view this was clearly a misguided attempt to appear 'pally'.

The complainant submitted that the representative then discussed Enbrel (etanercept) in psoriatic arthritis and ankylosing spondylitis. The complainant explained that he/she did not currently prescribe biologics for these conditions because of work done with regional specialists. The representative then asked what the complainant would use first line in these conditions; the complainant would normally use a monoclonal antibody, not Enbrel. The representative asked why, and the complainant replied because there was better data available for it with regard to extraarticular manifestations. The representative then asked the complainant why and what information that was based upon. The complainant reminded the representative that he/she did not have to justify prescribing decisions to him/her; this might be discussed with peers but not the representative. At this point the representative 'backed off' the questioning but shortly afterwards pressed the complainant again about prescribing habits and why he/she would prescribe a monoclonal antibody first. The complainant told the representative to stop pressing him/her about this and reiterated this was not his/her role. The complainant considered that the representative was trying to put on a show for his/her manager who had not said anything to the representative although it was clear that the complainant had got quite angry on two occasions.

Despite this, the representative asked why the complainant would use a monoclonal antibody as they had a longer half-life and then asked if the complainant knew that he/she had had a patient in the intensive therapy unit (ITU) over Christmas who had taken golimumab (Simponi co-marketed by Merck Sharp & Dohme and Janssen). The complainant explained that firstly, this was none of the representative's business; as the representative was not a clinician he/she should not discuss individual patients with anyone. It was completely inappropriate for the representative to try and discuss this with the complainant as the representative would not know the full story and whether golimumab was involved. The complainant stated that he/she would not expect any of the representatives from Merck Sharp & Dohme or Janssen to discuss any potential complication on Enbrel. At this point the complainant ended the meeting.

The complainant was extremely angry about the meeting and so called the representative's line manager. The complainant expected the manager to state that the representative had overstepped the mark, behaved inappropriately and apologise. If he/she had done that then the complainant would probably have accepted the apology. However the manager's reply was that when the representative realised that maybe he/she had gone too far' he/ she 'backed off'. The complainant explained to the manager that this was not so; although the representative backed off initially he/she returned to the same line of questioning. The complainant considered that the manager was defending the representative's actions and certainly did not apologise for them. The manager did apologise if the complainant considered that the representative had gone too far but not that the representative acted inappropriately. That was very different from apologising for the representative's actions.

The complainant previously had good relationships with Pfizer and was therefore quite shocked as he/ she had never been spoken to by any representative like that. The complainant had written to Pfizer but considered its response inadequate. The complainant had not had an apology from the representative or his/her manager.

The detailed response from Pfizer is given below.

The Panel invited further comments from the complainant and subsequently further information from Pfizer. Details were given below.

The Panel noted that there were differences in the parties' accounts of what happened it was extremely difficult in such cases to know exactly what had transpired. The complainant bore the burden of proof on the balance of probabilities. A judgement had to be made on the available evidence bearing in mind the extreme dissatisfaction usually required before an individual was moved to complain.

The Panel noted that the complainant felt extremely uncomfortable when the representative enquired about his/her health problem as it was a private issue and the complainant could not recall evermeeting the representative before or mentioning any illness to him/her. The Panel noted Pfizer's submission that the complainant had previously mentioned his/her illness to the representative and therefore he/she considered it appropriate and courteous to ask about it before talking about Enbrel and in the representative and his/her manager's view the complainant engaged in the discussion and did not appear to be uncomfortable. The Panel did not know what had been said by each party regarding the complainant's health issue. The Panel considered that whilst a general enquiry from a representative about a personal health issue might be appropriate and courteous, for a representative to initiate a detailed conversation about a personal medical matter might not be so and particularly when others were present.

Pfizer submitted that with regard to the patient on ITU, the representative stated that the case was previously disclosed by the complainant when they met in April 2013 and at no point did the representative have any personal information about the patient. The complainant disagreed that he/ she had ever discussed any patient with an infection on monoclonal antibody with the representative and had no recollection of the April 2013 meeting. The Panel noted that the interaction between the representative and the complainant in April 2013 was, according to Pfizer's call records, at a group meeting that both had attended rather than a one to one call.

The Panel noted Pfizer's submission that whilst the representative recognized that on two occasions the complainant was irritated by his/her approach, he/ she quickly broadened the discussion or changed the subject in an attempt to de-escalate the situation. The complainant, however, submitted that in his/her view there was no indication that the representative recognised that he/she was irritated during the consultation and queried why he/she felt the need to return to the discussion about extra-articular manifestations of psoriatic disease if he/she was aware of the complainant becoming irritated on the first occasion.

The Panel noted the complainant's allegation that the representative had questioned his clinical judgment. The Panel noted Pfizer's submission that in the course of a meeting between a company representative and a health professional it would not be unusual to discuss a clinician's prescribing strategy or appropriately challenge a clinician's prescribing strategy with fair and balanced information to suggest reasonable alternative prescribing decisions.

The Panel noted that the complainant stated that he/ she had not discussed any patient with an infection on a monoclonal antibody. The only one patient he/ she had ever had on golimumab remained well and the complainant stated that he/she had had no one admitted to ITU on any biological therapy since he/ she had started working at the hospital. The Panel noted that according to Pfizer the complainant and representative had attended a meeting in April where the discussion about the patient in ITU took place. Pfizer had not commented further on the complainant's statements in this regard. The Panel considered that the health professional would know what had happened to his/her patients.

The Panel noted that it was unfortunate that the complainant was upset by the interaction, nonetheless, it considered that there was no evidence before it to indicate on the balance of probabilities that the two elements of the discussion referred to by the representative were such as to disparage the complainant. It was impossible to determine where the truth lay. The Panel thus ruled no breach of the Code. This ruling was appealed by the complainant.

The Panel noted the differences between the accounts which involved one person's word against another. It also noted the cumulative effect of the matters raised by the complainant. The Panel considered however that there was not sufficient evidence to show that on the balance of probabilities that either the representative or the company had failed to maintain high standards; no breaches of the Code were ruled including Clause 2. These rulings were appealed by the complainant.

The Appeal Board considered that, upon appeal, the complainant had provided evidence to show that the patient in ITU on golimumab did not in fact exist. The Appeal Board noted from the complainant that this was the focus of the appeal as the complainant disputed, on a point of principle, the representative's submission that he/she had ever discussed any of his/her patients with any medical representative. The complainant could find no records to correlate with Pfizer's CRM entries for meetings with the representative. The complainant could not recall previously meeting the representative or his/her manager before the meeting at issue in January 2014. The complainant acknowledged that he/she might have seen them at some point but could not recall a meeting. Any meeting would have been limited to a greeting. The complainant also stated that the nature of his/her previous illness was known and the representative might have easily found out about it from other staff.

The Appeal Board was extremely concerned that Pfizer had not re-interviewed the representative or the manager in light of the new evidence provided in the appeal. This was despite the fact that the company agreed that the new evidence suggested that the ITU patient did not exist and that the prior meeting might have been misremembered or not happened. The Appeal Board was concerned that Pfizer had not questioned its representative or line manager to establish whether he/she had mistaken the complainant for a different doctor in a different hospital or had, in fact, fabricated the previous interaction. Either way the Appeal Board considered that on the balance of probabilities, it was satisfied that the representative had not discussed a patient in ITU on golimumab with the complainant in April 2013.

The Appeal Board noted that the representative's CRM entry for the meeting in April 2013, at which he/she stated he/she had discussed the patient in ITU with the complainant, did not include any notes about the meeting. Only one of the five CRM entries had a note. The complainant disputed the representative's submission. The Appeal Board considered that Pfizer should have explored the lack of CRM notes. The Appeal Board was concerned that the meeting at which the representative claimed to have first discussed a patient in ITU on golimumab with the complainant was nine months before the meeting at issue in January 2014 and yet, without any call notes to refer back to, the representative had managed to recall detailed information about that discussion.

The Appeal Board noted that Pfizer recognized that there were significant discrepancies between the complainant's account of the meeting in January and that of the representative and manager.

The Appeal Board noted the complainant's submission that he/she never discussed his patients with medical representatives. The Appeal Board considered that, given the evidence before it, on the balance of probabilities, in April 2013 the representative could not have discussed with the complainant one of his patients who was on golimumab and admitted to ITU as such a patient did not exist within the complainant's hospital either then or since; the reference to such a discussion at the meeting in January 2014 was thus unacceptable. The Appeal Board considered therefore that the representative had failed to maintain a high standard of ethical conduct; a breach of the Code was ruled. The appeal on this point was successful. Noting this ruling and its comments above the Appeal Board also considered that Pfizer failed to maintain high standards and it ruled a breach of the Code. The appeal on this point was successful.

The Appeal Board noted at the appeal that the complainant indicated that the appeal did not relate to the alleged disparagement. The Appeal Board thus upheld the Panel's ruling of no breach of the Code. The appeal on this point was unsuccessful.

The Appeal Board did not consider that the circumstances of this case warranted a ruling of a breach of Clause 2 and it upheld the Panel's ruling in that regard. The appeal on this point was unsuccessful.