AUTH/2828/3/16 - Clinical Nurse Specialist v Vifor

Conduct of representatives

  • Received
    21 March 2016
  • Case number
    AUTH/2828/3/16
  • Applicable Code year
    2016
  • Completed
    07 December 2016
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Appeal by respondent
  • Review
    February 2017 Review

Case Summary

​A hospital clinical nurse specialist in nutrition complained about the conduct of Vifor representatives. Vifor marketed Ferinject (ferric carboxymaltose for injection/infusion) for the treatment of iron deficiency when oral iron was ineffective or could not be used. 

The complainant explained that the trust currently used Ferinject and the two Vifor employees were looking for the complainant's colleagues from the inflammatory bowel disease (IBD) team. Some of the departments in the trust were looking at Monofer (iron isomaltoside), a competitor of Ferinject, marketed by Pharmacosmos. The complainant's colleague was not available to talk so the complainant introduced herself. In response to questions from the representative and his senior colleague as to why the trust might be switching to Monofer, the complainant explained that her colleagues should not have to justify their decision and certain departments would be looking at Monofer for a number of reasons, including a benefit to the patients. The complainant alleged that the representatives became very 'aggressive' in their manner/talk and started to tell her that [Monofer] was very dangerous and was not safe and queried how the complainant knew that it would be safe for patients. The complainant's colleague then interrupted to assist the complainant and reiterated that the trust wanted to do what was best for its patients. Eventually the complainant managed to ask the representatives to leave by offering her email address and stating that any concerns could be emailed to her. The complainant felt very upset and angry with the representative who had confused her and her colleague.

Once the Vifor employees left the complainant emailed her consultant to let him know that their behaviour and the way they just turned up to her department was inappropriate and unprofessional. The complainant discovered that the Vifor employees had, on more than one occasion, similarly upset several colleagues in other departments and had 'scaremongered' many of the trust's nursing teams with regard to the medicine [Monofer] it was trying to implement. The complainant provided details. 

The complainant stated that the Vifor representatives had tried to email her safety data suggesting that she had requested information but she had not. The complainant believed they had requested the information be sent to her themselves.

The complainant noted that the Vifor employees had subsequently turned up to her consultant's office and were told to leave and not come back. Future meetings with Vifor had been cancelled. The representatives were told that they had upset a few departments and although they wanted to apologise to the complainant they were told to stay away from the trust for a while.

The detailed response from Vifor is given below. 

The Panel noted that there were differences between the parties' accounts about what had been stated at the meeting and about the information which was subsequently sent to the complainant; 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 Vifor's submission that its representatives' accounts were consistent but different to that of the complainant. In that regard the Panel noted that statements from the complainant's colleagues were very similar to her own. 

The Panel noted that the complainant had alleged that the Vifor representatives had described Monofer as 'very dangerous' and 'not safe'. A colleague alleged that the representatives had tried to discredit Monofer 'in an intense way' and that they had referred to centres that had swapped from Ferinject to Monofer and 'had big reactions'. In this regard the Panel noted that in an account of the meeting one of the representatives stated that when asked if any centres had tried Monofer, he had replied that a couple had but then had to switch back. In response to a request for further information, Vifor submitted that when the nurses asked why the centres had switched back, the representative stated that he said he thought it was because of reactions. The Panel noted that following the meeting with the complainant, the consultant gastroenterologist had subsequently informed the representatives that there had been complaints from the infusion and IBD nurses although no details were given. The consultant had told the representatives that they should not have seen the nurses without seeing him. 

The Panel noted Vifor's submission that during initial training, representatives were briefed not to discuss competitor products in detail and that questions about competitors' medicines should be referred to the relevant company. At the December 2015 sales conference, Vifor representatives were specifically reminded not to discuss the safety of competitor products. A briefing document approved in December 2015, however, stated on the concluding slide that safety and tolerability was a key factor in choosing an intravenous (IV) iron. Representatives were informed that 5 named accounts had switched back to Ferinject from Monofer. No reason was stated for the switch but it was reasonable that representatives would assume that it was to do with safety and tolerability given that was the heading to the slide. The slide also referred to the Lareb report and quoted the following from it: 'special attention should be given to the comparison of the safety profile of the different intravenous iron-containing medicines and in particular to the safety profile of iron isomaltoside [Monofer]'. Finally representatives were told to 'Be proactively reactive. If a customer asks about the detailed safety of Ferinject beyond the SPC, please refer them to medical Information who can provide detailed information and investigate further if necessary'. 

A briefing document approved in January 2016 (Questions and Answers. Reactive) listed customers' comments about Monofer and stated 'What we need to do is reactively discuss the FACTS in an accurate and balanced way, to allow the customer to make an informed decision'. The final message of the document was 'The Ferinject proposition is strong, b confident, we have the best treatment'.

Also in January 2016 the representatives had been given a slide set which specifically differentiated Ferinject from Monofer and was for proactive use in threatened accounts that were considering switching to Monofer and in accounts that had switched to Monofer. Again, the briefing material for that tool stated, in summary, that 'The Ferinject proposition is strong, be confident, we have the best treatment'. In the Panel's view the briefing material was at odds with Vifor's submission that it did not permit representatives to discuss comparative safety in a promotional environment. The complainant was shown the tool in response to a query about using 2g of Monofer in a single visit. The slide shown to the complainant, and marked as such by Vifor, stated that the way in which the Monofer dose was calculated (the Ganzoni formula) was 'recognised as inconvenient, prone to error, inconsistently used in clinical practice, and it underestimates iron requirements'. The briefing on this slide referred to Ganzoni-based dosing as being problematic. 

In the Panel's view, there was no doubt that Vifor was specifically targeting Monofer sales and that the representatives had been briefed to discuss, or solicit ('be proactively reactive') questions about the comparative safety of Ferinject vs Monofer and to view the Lareb report as a resource in that regard even if they could not distribute it themselves. As noted above, the representatives had also been informed, in a slide headed 'Safety and tolerability', that 5 accounts had switched back to Ferinject from Monofer. 

The Panel considered that on the balance of probabilities, given the strident tone and content of the sales materials and briefings, the representative had started to spread doubt amongst infusion nurses about the safety of Monofer as alleged and in that regard had offered misleading comparisons with Ferinject. Breaches were ruled which were upheld on appeal by Vifor. The Panel considered that the briefing material advocated a course of action which was likely to be in breach of the Code. A breach of the Code was ruled and upheld on appeal by Vifor. 

The Panel noted that the complainant had been sent a copy of the Lareb report which she stated she had not requested. Vifor submitted that she had asked for comparative safety data and that the Lareb report was the most appropriate document to send as there was no head-to-head clinical trial data of Ferinject vs Monofer. The Panel noted from a short email exchange between the complainant and one of the representatives that it seemed clear that issues about the safety of Monofer had been raised by the representative, not by the complainant. The Panel noted Vifor's submission that the complainant questioned the safety data and asked for comparative safety data. In that regard the complainant's request for more information was not unsolicited. The representative subsequently emailed the medical information department and stated that the complainant had 'kindly requested a copy of the Lareb report'. This was not so. In response the medical information department replied with a link to the Lareb report; the only substantive statement in the email was that '…Lareb has received concerns from multiple Dutch hospitals in relation to [Monofer] after the switch from [Ferinject]. Doctors and nurses reported an increase in the severity and incidence of allergic reaction. The report has not mentioned any specific safety concerns with [Ferinject]'. The latter statement was untrue as the report detailed 7 reports of hypersensitivity/anaphylacsis associated with the use of Ferinject. 

The Panel noted that the query was not unsolicited and that the representative had misrepresented to the medical information department what the complainant had asked for. Further the email from the medical information department did not put the results of the Lareb report in to context and did not note that there were no direct head to-head comparisons of Ferinject and Monofer. The statement that the report had not mentioned any specific safety concerns with Ferinject was inaccurate. The Panel thus considered that the email from medical information could not take the benefit of the exemption to the definition of promotion, it was neither unsolicited nor fair and balanced. The complainant had thus been sent a promotional email without her prior permission. A breach of the Code was ruled. 

The Panel noted that the Code did not prevent representatives 'cold calling' on health professionals provided that the frequency and duration of such calls was appropriate and that the representatives respected the wishes of those upon whom they called and observed the arrangements in force at the establishment. The complainant had not provided any evidence that the representatives had not observed the arrangements in force at the hospital neither was there evidence to show that the representatives had not respected the complainant's wishes. No breach of the Code was ruled. 

The Panel noted its rulings and comments above and considered that the representatives had not maintained a high standard of ethical conduct. In that regard high standards had not been maintained. Breaches of the Code were ruled. Vifor appealed the ruling that high standards had not been maintained. 

​It only accepted the ruling insomuch as the representatives had not maintained a high ethical standard in relation to the provision of the Lareb report. The Appeal Board considered this ruling encompassed the whole case and insofar as the point was raised ruled against it. The Appeal Board upheld the Panel's ruling that high standards had not been maintained. The Panel noted that a ruling of a breach of Clause 2 was a sign of particular censure. The Panel was concerned that the two representatives appeared to be cold calling on infusion and IBD nurses specifically to solicit discussion about Ferinject vs Monofer. The representatives had not called upon the relevant consultant – although the Panel noted that securing a meeting with him was not easy. The promotional tool which they had been given was specifically for proactive use in, inter alia, threatened accounts that were considering switching to Monofer; the hospital trust in question appeared to be one such account. The Panel noted the complainant's and her colleagues' views that the representatives had been scaremongering and that their approach was challenging and aggressive. The representatives had ensured that the complainant had received a copy of the Lareb report and in the Panel's view the covering medical information email had been promotional. The Panel noted its rulings and comments above and considered that, on the balance of probabilities, Vifor's activities and materials associated with the promotion of Ferinject had been such that they brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of the Code was ruled which was upheld on appeal by Vifor.​