AUTH/1824/4/06: Media/Director v Servier – Protelos ‘dual action bone agent’ claims (No breach on appeal) | PMCPA Case

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Key facts

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Case number	AUTH/1824/4/06
Parties	Media/Director v Servier
Product	Protelos (strontium ranelate)
Therapy area / indication	Postmenopausal osteoporosis; to reduce risk of vertebral and hip fractures
Promotional claims at issue	“the first dual action bone agent”; “the only drug to simultaneously increase bone formation and decrease bone resorption”
Complaint trigger	D&TB April 2006 article criticising promotion
Clauses considered	Clause 7.2; Clause 7.4
Panel decision	Breaches of Clauses 7.2 and 7.4 (claims misleading/not capable of substantiation)
Appeal outcome	No breach of Clauses 7.2 and 7.4 (claims supportable as statements of fact)
Notable Appeal Board comment	Concern that promotional context could imply clinical superiority without supporting data; requested Servier review context of claims
Complaint received	06 April 2006
Case completed	21 June 2006
Applicable Code year	2006

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

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An April 2006 Drug and Therapeutics Bulletin article criticised Servier’s promotion of Protelos (strontium ranelate) for postmenopausal osteoporosis.
The Director took the matter up as a complaint under the 2006 ABPI Code.
The challenged promotional claims were: “the first dual action bone agent” and “the only drug to simultaneously increase bone formation and decrease bone resorption”.
The Authority asked Servier to respond in relation to Clauses 7.2 and 7.4.
Servier argued the claims were supported by the SPC/PIL and clinical trial biochemical marker data (and some biopsy data), and that biochemical markers were accepted surrogates in this therapy area.
The Panel initially ruled the claims misleading/not sufficiently clinically robust and found breaches.
Servier appealed; the Appeal Board assessed the claims as statements of fact (not their promotional context) and overturned the Panel’s ruling.

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No breach of the Code (Appeal Board).
The appeal was successful for both claims under Clauses 7.2 and 7.4.
The Appeal Board nevertheless expressed concern that, in the supplied promotional context, the claims could imply clinical superiority over other medicines without supporting data, and asked that Servier be advised to review the context of use.

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