AUTH/2635/8/13 - Anonymous v Norgine

Promotion of Dantrolene

  • Received
    20 August 2013
  • Case number
    AUTH/2635/8/13
  • Applicable Code year
    2012
  • Completed
    18 October 2013
  • No breach Clause(s)
    3.2, 7.2, 12.1, and 22.1
  • Breach Clause(s)
    7.2, 7.4, 9.1, and 22.2
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2013

Case Summary

​An anonymous, non-contactable complainant who described themself as part of the academic anaesthetic community complained about a press release for Dantrium (dantrolene) published on Norgine Pharmaceuticals UK website. Dantrium was indicated for the treatment of malignant hyperthermia (MH).

The complainant alleged that the press release headed 'New Epidemiological Study in Malignant Hyperthermia Reinforces the Effectiveness of Dantrium (Dantrolene Sodium) in Reducing Fatal Anaesthetic Reaction' was underhand promotion. It discussed an epidemiological study of survivors which did not mention mortality data in the conclusion. The complainant further alleged that the indication for dantrolene made no reference to reduction in mortality and the press release was thus not in line with the medicine's licensed indication.

The detailed response from Norgine is given below.

The Panel noted that the press release discussed Riazi et al. This was an epidemiological study which examined reported data on index adverse anaesthetics and evaluated associations between complications, clinical signs and dantrolene treatment to facilitate timely clinical diagnostics and treatment of MH. The Panel noted that 57 (44.2%) of patients in the study received Dantrium after an adverse anaesthetic reaction. When the time between onset of the first clinical sign and dantrolene administration was longer, the proportion of patients experiencing a complication was also larger. Data showed that for each 10 minute delay in Dantrium administration complications increased substantially; beyond 50 minutes complications increased to 100%. There were no significant differences between the group that received and the group that did not receive Dantrium as regards duration of anaesthesia, the diagnostic test for MH susceptibility, or genetic results. The study authors discussed its limitations including data availability and that the study only looked at patients who had survived the reaction and were referred for a MH susceptibility test. Overall the authors, concurring with previous studies, concluded that early diagnosis and rapid Dantrium treatment reduced MH associated complications. The study introduction noted that studies on the incidence of adverse MH reactions demonstrated a MH morbidity rate of 35% and a MH mortality rate as high as 12%.

The Panel noted that the press release began by noting the incidence of adverse anaesthetic reactions triggered by succinylcholine alone. The press release noted that Riazi et al supported previous findings that early recognition and prompt administration of dantrolene was critical for patientsurvival and reduction of complications. The press release stated that the 'study was worth noting because it also highlights how having Dantrolene readily available can reduce the morbidity and mortality caused by malignant hyperthermia and therefore suggests the importance of reviewing stock levels in hospitals'.

The Panel noted Norgine's submission that MH was often fatal if not effectively treated. Dantrium was the sole licensed treatment for the condition and its use was specified in multiple guidelines. It was recommended that it was a vital to stock dantrolene pre-emptively. The Panel also noted Norgine's submission that the epidemiology of MH and how dantrolene use might affect it at the population level was relatively less well studied and important new data rarely emerged. The Panel considered that in these circumstances, and given its comments on Riazi et al above, it was newsworthy. The Panel therefore did not consider that the press release had been released for promotional purposes only, as alleged. Nor did the Panel otherwise consider that the press release promoted Dantrium to the general public. No breach of the Code was ruled.

The press release was not disguised promotion and no breach of the Code was ruled. The Panel did not consider that the heading to the press release implied that Dantrium was licensed for reducing mortality as alleged. The heading 'New epidemiological study in malignant hyperthermia reinforces the effectiveness of Dantrium in reducing fatal anaesthetic reaction' clearly described the condition being treated, MH. The adjective 'fatal' was used to describe the trigger, an anaesthetic reaction. The Panel considered it would have been helpful to clearly state that the study was in survivors, and to state the licensed indication in the body of the press release rather than the editorial. The Panel noted the relationship between time of administration and complications. The Panel considered that whilst the statement in the press release that the study 'highlights how having Dantrolene readily available can reduce the morbidity and mortality caused by malignant hyperthermia and therefore suggests the importance of reviewing stock levels in hospitals' was not unreasonable in relation to morbidity it was not correct in relation to mortality as the retrospective study only examined data in survivors and this was not made clear. The claim was inaccurate and misleading in this regard. In the Panel's view, this misleading impression was compounded by two statements in the press release. The first paragraph of the press release which stated 'the study also further underlines that early recognition and prompt administration of dantrolene intravenous are critical for patient survival and reduction of complications' (emphasis added) and the quotation from a named doctor that 'These new data are very importantas they emphasize that survival from a malignant hyperthermia crisis, a rare condition, is highly dependent on early recognition and prompt action, and that the rapid use of dantrolene can ensure patient survival' (emphasis added). The Panel considered that the press release was inaccurate and therefore misleading about Riazi et al and mortality and breaches of the Code were ruled. The press release was not capable of substantiation in this regard; a breach of the Code was ruled. However, and on balance, the Panel did not consider that the press release implied that Dantrium was licensed to reduce mortality as alleged, nor was it inconsistent with the terms of its marketing authorisation in this regard. No breaches of the Code were ruled on this point.

The Panel considered that the company had failed to maintain high standards and a breach of the Code was ruled.