AUTH/3301/1/20 - Anonymous v Vifor

Promotion of Ferinject

  • Received
    22 January 2020
  • Case number
  • Applicable Code year
  • Completed
    27 July 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, contactable individual complained that the website (ref UK-NP-1900153, September 2019) was disguised promotion of Vifor Pharma UK’s product Ferinject (ferric carboxymaltose). Ferinject was indicated for the treatment of iron deficiency when oral iron preparations were ineffective or could not be used.

The complainant alleged that an employee’s conduct led to pressure on signatories. Promotion related to both direct and indirect reference to products and Vifor had products which were intravenous (IV) iron preparations eg Ferinject. Ferinject also had evidence within cardiac patients (section 5.1 of the Ferinject summary of product characteristics (SPC) referred).

The complainant alleged that the ivironheart website aimed at health professionals looked and felt promotional with numerous claims about IV iron. The website was not fair and balanced in that it described the disadvantages of oral iron therapy but only the positives of IV iron therapy in relation to cardiovascular outcomes. The complainant alleged that, given the way the information was falsely presented, readers could assume that IV iron had no side effects. The complainant stated that there should be prescribing information and adverse event reporting and queried whether the website had been certified.

The detailed response from Vifor is given below.

The Panel noted Vifor’s submission that the website was a non-promotional, medical educational website aimed at health professionals’ to raise awareness of the role of iron in the heart, explain why heart failure patients might be iron deficient and to provide information on the consequences of iron deficiency for heart failure patients. It included reference to the treatment (both oral and intravenous) of iron deficiency in heart failure noting that oral iron, was considered to be of limited benefit in heart failure.

The Panel noted that it appeared that the site was intended for healthcare professionals treating patients with iron deficiency in chronic heart failure.

In the Panel’s view the imagery and claims for IV iron and statements about oral iron appeared to be of the type generally associated with promotion. The Panel considered that the content of the Vifor website, including the claims for IV iron and the reasons not to use oral iron was promotional for Vifor’s IV iron products.

The Panel disagreed with Vifor’s submission that the reference to IV irons generally on the website was not a reference, either direct or indirect, to any specific medicine. There were references to specific medicines in the material, these being oral and IV treatments for iron deficiency. In the Panel’s view the website promoted IV iron and Vifor marketed two IV iron preparations, namely Ferinject and Venofer. The website could not be considered anything other than promotional for those medicines.

The Panel then went on to consider the matter in relation to Vifor’s subsequent submission that it had discovered that there was a link between the website and a promotional item, Vifor’s global cardiology awareness campaign sales aid (ref UK-FCM-1800049) which included promotional information in relation to Ferinject. The briefing material for this sales aid (ref UK-FCM-1900051) gave background on the ‘Cardiology Awareness Campaign’ and referred to the purpose of the ‘unbranded disease awareness campaign’ as aiming to increase the number of iron deficient heart failure patients treated with IV iron, decrease the number inappropriately treated with oral iron and drive awareness of the European Society of Cardiology (ESC) diagnostic criteria for treating patients. The briefing material for the sales aid stated that the desired outcome to achieve for certain health professionals (evidence followers) was to acknowledge that Ferinject was the only iron therapy recommended by the ESC 2016 Heart Failure Guidelines and treat their patients accordingly. Representatives were instructed to switch to using the Ferinject branded sales aid once a customer believed in the value of IV iron for iron deficient heart failure patients ‘… and continue to differentiate and promote the unique benefits of Ferinject for heart failure patients’. The Panel noted that the website which contained imagery and content identical to that within the sales aid (UK-FCM-1800049) as acknowledged by Vifor appeared to be part of Vifor’s campaign to promote Ferinject.

The Panel noted that the website did not include Ferinject or Venofer prescribing information nor did it include a clear and prominent statement as to where the prescribing information could be found. It did not include the requisite statement about reporting adverse events. The Panel therefore ruled breaches of the Code.

The Panel noted that the website had not been certified for promotional use and thus ruled a breach of the Code.

The Panel noted its comments above and did not consider that the Vifor website was disguised promotion; it was clearly promotional. The Panel therefore ruled no breach of the Code.

The Panel noted Vifor’s submission that the website should contain more comprehensive information about both oral and IV irons and the website had been deactivated in order to address this. The Panel noted its comment above with regard to the content of the website in relation to the limitations of oral iron and the clinical benefits of IV iron. The Panel did not consider that the website was sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of the medicines. The Panel further considered that the comparison between oral and IV iron portrayed by the website was misleading as alleged. Breaches of the Code were ruled.

The Panel was concerned to note that Vifor had failed to recognise that the website promoted its two products Ferinject and Venofer. The Panel was further concerned that this had not been picked up in relation to the Cardiology Awareness Campaign Sales Aid (UK-FCM-1800049) considering the link between the website and the sales aid and its associated briefing material. The same signatory had certified the three pieces ie the Cardiology Awareness Campaign Sales Aid, its associated briefing and the website. The Panel considered that Vifor had failed to maintain high standards and a breach of the Code was ruled.

The Panel noted that the complainant had raised concerns about a Vifor employee alleging this led to pressure on the signatories. The Panel noted that the complainant bore the burden of proof and had not provided evidence to establish his/her complaint on the balance of probabilities in this regard. The Panel therefore ruled no breach of the Code.

It appeared that Vifor might have confused a non-promotional disease awareness campaign, which was usually aimed at members of the public rather than health professionals, with a promotional campaign for Ferinject. Further it appeared that Vifor staff had not fully understood the materials, their links to each other and the impact of relevant Code requirements.

Noting its comments and rulings above, the Panel considered that Vifor had brought discredit upon, and reduced confidence in, the industry and a breach of Clause 2 was ruled.