AUTH/1825/4/06: ProStrakan v Shire – Calcichew-D3 Forte ‘preferred by 80%’ claim ruled misleading

📅 2006 | 🖉 Dr Anzal Qurbain
📊

Key facts

Case numberAUTH/1825/4/06
ComplainantProStrakan Group Plc
RespondentShire Pharmaceuticals Ltd
ProductCalcichew-D3 Forte
MaterialJournal advertisement (Pulse, 2 March 2006), ref 003/0419a
Main claim“Chew Calcichew-D3 Forte for Ten Seconds for a pleasant surprise. In a comparative study, Calcichew-D3 Forte was preferred over Adcal-D3 by 80% of patients”
Evidence citedRees and Howe (2001)
Key study detailsRandomised, investigator-blind, crossover, multicentre; 102 patients ≥60; 7 days on each product; VAS palatability measures; preference question at end
Panel’s core concernAd implied “pleasant”/better taste; study showed no taste difference and preference likely driven by other attributes; insufficient detail on what was preferred; overall misleading comparison
Breach clauses7.2 and 7.3
SanctionUndertaking received
Complaint received06 April 2006 (HTML) / 07 April 2006 (PDF)
Case completed04 June 2006 (HTML) / 05 June 2006 (PDF)
AppealNo appeal
Applicable Code year2006

Download the full case report (PDF)


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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI
🎬 Expert Video Walkthrough
🎬
Video walkthrough — coming for members
Subscribe now and get expert video analysis for every case as we publish them.
Subscribe — from £299/yr
📋

What happened

  • ProStrakan complained about a Shire journal advertisement for Calcichew-D3 Forte (ref 003/0419a) published in Pulse, 2 March 2006.
  • The ad stated: “Chew Calcichew-D3 Forte for Ten Seconds for a pleasant surprise. In a comparative study, Calcichew-D3 Forte was preferred over Adcal-D3 by 80% of patients”, referenced to Rees and Howe (2001).
  • The cited study was a randomised, investigator-blind, crossover, multicentre study with 102 patients aged ≥60 years, with 7 days on each product; preference/palatability was assessed using visual analogue scales and a preference question at the end.
  • Key contextual points included: no difference between products on “taste” in the study; preference likely influenced by other attributes (grittiness, chalkiness, ease of chewing/swallowing, stickiness); 64% of recruited patients were already established on Calcichew-D3 Forte; and the ad’s imagery/wording suggested “pleasant” taste.
  • Shire said it had agreed (31 March 2006) to withdraw the advertisement as soon as feasible and to remove the terms “Ten Second Trial” and “Surprisingly Good” from future materials, but defended use of the 80% preference statement.
⚖️

Outcome

  • The Panel ruled the claim was a misleading comparison.
  • Breach found of Clauses 7.2 and 7.3.
  • No appeal.
🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value
£249/year
Annual — save £99
or
£29/mo
Monthly
Join Now — Instant Access

⭐ Business Intelligence Access

See the full compliance picture for every pharma company

291 Company Intelligence Reports — breach patterns, appeal history, industry ranking, PDF export.

Request Access →
⭐ Flagship Programme

AQP Flagship Path — the complete UK ABPI signatory programme

12 modules. 12 weeks. Final Signatory readiness. The industry standard for ABPI Code signatories — £995 + VAT.

Enrol — AQP Path Learn more

📰 Weekly PMCPA Case Breakdown

One real case. One key lesson. Every week — free.

Subscribe Free
🎓 AQP Training