AUTH/3321/3/20 - Complainant v A Menarini

Disguised promotion of Ranexa

  • Received
    10 March 2020
  • Case number
    AUTH/3321/3/20
  • Applicable Code year
    2019
  • Completed
    02 June 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant, who described him/herself as a concerned UK health professional, complained that material, hosted on the Guidelines in Practice website and produced by A Menarini, was disguised promotion for Ranexa (ranolazine). Ranexa was indicated in certain adults as add-on therapy for the symptomatic treatment of stable angina.

The complainant drew specific attention to a webpage which presented a supplement entitled ‘Delivering savings by improving the management of patients with chronic coronary syndrome in the [acute medical unit] setting: a case study’ (Ako and Smith 2019). The complainant stated that he/she did not realise that the supplement was a promotional item until he/she noticed there was a link to prescribing information; the same was true for the downloadable copy of the supplement which contained prescribing information at the back of the item. The complainant alleged that both the on-line and downloadable items were disguised promotion.

The complainant further noted, with regard to patient safety, that the prescribing information was from 2017 and that updates had included special warnings on QT prolongation which was extremely relevant to the those who would be treated with Ranexa. Given that the material was created in 2019, the complainant queried whether the company’s review process was sufficiently robust.

The detailed response from A Menarini is given below.

The Panel noted that, at the outset, the online material included a statement that it had been commissioned and funded by A Menarini with a more detailed description of the company’s involvement at the end of the piece. Readers’ attention was also drawn, at the outset, to a link to prescribing information. In the Panel’s view, health professionals visiting the webpage at issue would be immediately aware that the material was developed by A Menarini and would be likely to assume that it would include information on A Menarini’s medicines and therefore be promotional. The Panel did not consider that the promotional nature of the on-line material had been disguised. No breach was ruled.

The downloadable copy of the material did not state at the outset that the material had been commissioned and funded by A Menarini. The Panel noted A Menarini’s submission that it would have been helpful to have an additional statement of its involvement at the top of the front page and it would ensure that that was the case for future such materials. That the company had any involvement in the piece at issue was only noted in a footnote at the bottom of the front page along with directions as to where to find the prescribing information. The Panel accepted that a health professional downloading the PDF copy from the website would have done so knowing that the piece was promotional. In the Panel’s view, however, the hard copy had to be capable of standing alone with regard to the requirements of the Code. Given that the company’s involvement was not immediately obvious on the printed material, the Panel considered that its promotional nature had been disguised. A breach of the Code was ruled.

The Panel noted A Menarini’s submission that in November 2018 Section 4.4, Special warnings and precautions for use, of the Ranexa summary of product characteristics (SPC) was updated to include the following:

‘QT prolongation: Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner.’

The rest of the information related to the QT prolongation in Section 4.4 remained the same as the previous version dated 15 December 2016:

‘A population-based analysis of combined data from patients and healthy volunteers demonstrated that the slope of the plasma concentration-QTc relationship was estimated to be 2.4msec per 1000ng/ml, which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000mg twice daily. Therefore, caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval (see section 4.5 also).’

The Panel noted that the prescribing information at issue, produced in January 2017 and reapproved in February 2019, stated in the Warnings and Precautions section that for QT prolongation, caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval. In the Panel’s view, the statement added to the November 2018 SPC did not materially affect the succinct warning required in the prescribing information. Readers were advised to consult the SPC for full prescribing information and in doing so they would discover the reasons behind the warning. The Panel noted that the complainant had not stated why he/she considered that the issue was a matter of patient safety and in that regard considered that he/she had not discharged the burden of proving his/her complaint on the balance of probabilities. On the information before it, the Panel did not consider that the prescribing information was inadequate with regard to the warning given about QTc interval prolongation. No breach of the Code was ruled.

The Panel noted its comments and rulings above and considered that, in the particular circumstances of this case, A Menarini had not failed to maintain high standards and no breach of the Code was ruled including no breach of Clause 2.