Anonymous v Norgine: Dantrium press release misleading on mortality claims (AUTH/2635/8/13)

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Key facts

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Case number	AUTH/2635/8/13
Parties	Anonymous v Norgine
Product	Dantrium (dantrolene)
Indication (as stated)	Treatment of malignant hyperthermia (MH)
Material	Press release on Norgine corporate website (media section)
Main issue	Implied mortality/survival benefit from a survivors-only retrospective epidemiological study; misleading and unsubstantiated impression
Complaint received	20 August 2013
Case completed	18 October 2013
Applicable Code year	2012
Breach clauses	7.2, 7.4, 9.1, 22.2
No breach clauses	3.2, 7.2, 12.1, 22.1
Sanctions	Undertaking received
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous complainant from the academic anaesthetic community challenged a Norgine website press release about Dantrium (dantrolene) for malignant hyperthermia (MH).
The press release headline referenced “reducing fatal anaesthetic reaction” and the body suggested dantrolene availability could reduce “morbidity and mortality”.
The release discussed Riazi et al, an epidemiological, retrospective study that examined reported data and associations between complications and timing of dantrolene treatment.
Key limitation: the study only looked at patients who had survived the reaction and were referred for MH susceptibility testing; it did not provide mortality outcomes.
The press release included statements implying mortality/survival benefit (eg “critical for patient survival” and that rapid use “can ensure patient survival”).
Norgine argued the release was a non-promotional, factual communication aimed at journalists and posted in the media section of its corporate website.

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No breach of Clause(s) 22.1 (not promotion to the public) and 12.1 (not disguised promotion) because the Panel considered the press release newsworthy and not issued for promotional purposes only.
Breach of Clause(s) 7.2 and 22.2 because the press release was inaccurate and misleading about Riazi et al in relation to mortality/survival.
Breach of Clause(s) 7.4 because the mortality/survival impression was not capable of substantiation (the study was in survivors and did not support mortality reduction claims).
No breach of Clause(s) 3.2 (and no breach of 7.2 on the specific point alleged) because, on balance, the Panel did not consider the press release implied Dantrium was licensed to reduce mortality or was inconsistent with the marketing authorisation.
Breach of Clause(s) 9.1 for failure to maintain high standards.

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