AUTH/2517/6/12: Anonymous v ProStrakan – Adcal-D3 Caplet promotion and sales briefing (Clause 15.9 breach) | PMCPA Case

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Key facts

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Case number	AUTH/2517/6/12
Complainant	Anonymous, non-contactable (“An aggrieved Surgery”)
Company	ProStrakan Limited
Medicine	Adcal-D3 Caplet (calcium carbonate and colecalciferol)
Issue	Allegedly misleading use of clinical trial data; alleged “switch programme”; adequacy of representative briefing and conduct
Key studies referenced	Chapuy et al (1992); Tang et al (2007)
Panel finding on promo materials	No breach of Clauses 7.2 and 7.4 (materials clear data related to dose; studies could substantiate claims on narrow ground)
Panel finding on representatives	No breach of Clause 15.2 (not established on balance of probabilities)
Panel finding on internal briefing	Breach of Clause 15.9 (misleading by omission; inconsistent caveats re study inclusion)
Therapy review service	No breach of Clauses 18.1 and 18.4 (not a switch service; not an inducement)
Other clauses considered	No breach of Clauses 9.1 and 2
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	18 June 2012 (PDF) / 19 June 2012 (web page)
Case completed	5 September 2012
Appeal	No appeal
Applicable Code year	2012

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

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An anonymous, non-contactable complainant (“An aggrieved Surgery”) complained about ProStrakan’s practices and representatives relating to Adcal-D3 Caplet (calcium carbonate and colecalciferol).
The complainant alleged a representative and manager promoted Adcal-D3 Caplet using the same information as other Adcal products and assured them Adcal-D3 Caplet was included in the cited clinical trials, which the complainant believed was impossible given the studies’ age.
The complainant alleged the surgery used ProStrakan’s “switch programme” to move patients from other calcium supplements to Adcal-D3 Caplet based on misleading data.
ProStrakan stated the key efficacy claims were supported by Chapuy et al (1992) and Tang et al (2007); neither study used Adcal products, but Chapuy et al data featured in Section 5.1 of the Adcal-D3 Caplet SPC and underpinned the UK marketing authorisation (bibliographic filing based on established use).
ProStrakan denied offering a switch service and described a calcium/vitamin D therapy review service with controls intended to prevent it being linked to promotion or used as an inducement.

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No breach was ruled for the detail aid and doctor leavepiece being misleading: the Panel considered they were clear the efficacy data related to doses (1200mg calcium and 800IU vitamin D3 daily) rather than specifically to Adcal-D3 Caplet.
No breach was ruled for substantiation: the Panel considered Chapuy et al and Tang et al could, in principle and on a narrow ground, substantiate claims for Adcal-D3 Caplet given the established-use basis of the marketing authorisation.
No breach was ruled regarding alleged representative conduct (high standards): the Panel did not consider the complainant had established, on the balance of probabilities, that the representative/manager failed to maintain a high standard of ethical conduct.
Breach ruled: the sales force briefing material was found misleading by omission and likely to lead to a breach of the Code (Clause 15.9).
No breach was ruled for the therapy review service being a switch service or an inducement (Clauses 18.4 and 18.1).
No breach of Clause 2 was ruled.

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