AUTH/2162/8/08 ProStrakan v Galen: Promotion of Calceos (taste, adherence and fracture-risk claims)

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Key facts

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Case number	AUTH/2162/8/08
Case reference	Promotion of Calceos
Complainant	ProStrakan
Respondent/company	Galen
Product(s)	Calceos; comparator products mentioned: Adcal-D3, Calcichew-D3 Forte
Material/channel	Six-page, gatefolded leavepiece; letter to a hospital consultant
Key issue	Misleading implications and lack of substantiation for taste/preference, long-term adherence, flavour enhancement, cost-comparison context implying taste advantage, and adherence/fracture-risk benefit being read as applying to Calceos; separate allegation about consultant letter not upheld
Dates (received/completed if stated)	Complaint received 18 August 2008; Case completed 5 November 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 7.2; Clause 7.4 (leavepiece). No breach of Clause 7.2 (letter)
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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ProStrakan complained about Galen’s promotion of Calceos (calcium/vitamin D3) via a six-page, gatefolded leavepiece and a letter to a hospital consultant.
ProStrakan supplied Adcal-D3 and said inter-company negotiation had not resolved the matter.
The leavepiece included claims and presentations about: taste being important for patient preference and long-term adherence (referenced to Reginster et al 2005); excipients (xylitol and sorbitol) enhancing lemon flavour (referenced to the Calceos SPC and the Handbook of Pharmaceutical Excipients 2006); a cost comparison page headed “Taste the NEW savings with Calceos” comparing Calceos with Adcal-D3 and Calcichew-D3 Forte; and a bar chart headed “High adherence with calcium and vitamin D supplements doubles the reduction in fracture risk” (referenced to Tang et al 2007) with the Calceos logo beneath.
Galen stated that following an internal review the leavepiece was already being withdrawn.
The Panel considered how the cited studies and references related to the claims and the overall impression created in the context of a Calceos promotional piece.
For the separate letter to a hospital consultant, the Panel reviewed whether it referenced Tang et al and whether it made adherence/fracture-risk claims.

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Leavepiece: Breaches were ruled for misleading claims and lack of substantiation relating to taste/preference, long-term adherence, flavour enhancement, the “Taste the NEW savings” cost-comparison context, and the adherence/fracture-risk bar chart/claim.
Letter to hospital consultant: No breach was ruled for the allegation that it misleadingly referenced Tang et al; the Panel found the letter did not refer to published studies and did not mention adherence and fracture risk.

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Clause 7.2 (misleading claims): Breached in relation to (1) “Taste is important for… Patient preference… Long-term patient adherence…” (Reginster et al), (2) “The additive effect of xylitol and sorbitol enhances the lemon flavour of Calceos” (SPC/Handbook), (3) “Taste the NEW savings with Calceos” heading in the context of a cost comparison, and (4) “High adherence… doubles the reduction in fracture risk” (Tang et al) in context with the Calceos logo and surrounding taste/adherence messaging.
Clause 7.4 (substantiation): Breached in relation to (1) “The additive effect of xylitol and sorbitol enhances the lemon flavour of Calceos” and (2) the “High adherence… doubles the reduction in fracture risk” claim/bar chart as presented in context for Calceos.
No breach of Clause 7.2 was ruled regarding the allegations about the letter to the hospital consultant.

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