AUTH/1847/6/06: PCT head of prescribing complaint against Altana over Alvesco positioning and misquoted endorsement

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Key facts

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Case number	AUTH/1847/6/06
Complainant	Head of prescribing at a Primary Care Trust (PCT)
Respondent	Altana Pharma Limited
Product	Alvesco (ciclesonide)
Main issue	Misrepresentation/misquotation implying PCT prescribing lead endorsement of product positioning within BTS asthma guideline steps; lack of formal permission for quotation/attribution
Applicable Code year	2006
Complaint received	9 June 2006
Case completed	25 September 2006
Panel decision	Breach of Clauses 7.2, 7.4, 9.1, 11.3, 15.2; no breach of Clauses 2, 7.6
Appeal	Appeal by respondent; unsuccessful (breaches upheld)
Sanctions	Undertaking received; additional sanctions not stated

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

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The head of prescribing at a Primary Care Trust (PCT) met two Altana representatives to discuss Alvesco (ciclesonide): evidence, cost and place in therapy.
The complainant said reps positioned Alvesco after beclometasone dipropionate (BDP) but as an alternative to other steroids and to step 3 of the British Thoracic Society (BTS) asthma guidelines, and repeatedly sought written endorsement from the PCT; this was repeatedly refused.
The complainant later learned an Altana representative told a practice nurse that the complainant had endorsed that positioning.
The complainant said he only supported Alvesco at BTS step 2 in a small niche: patients who experienced oral side effects with BDP affecting compliance—not as a substitute for stepping up to step 3 when uncontrolled.
Altana argued its positioning was within step 2, after BDP and before combination therapy, and that there had been a misunderstanding; it also appealed on evidential/procedural grounds.
The Panel and then the Appeal Board concluded the complainant’s views had been misrepresented and that formal permission had not been obtained for the quotation/attribution used with the practice nurse.

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Breach rulings: Clauses 7.2, 7.4, 9.1, 11.3 and 15.2.
No breach rulings: Clauses 2 and 7.6.
Altana’s appeal was unsuccessful; the Appeal Board upheld the Panel’s breach rulings.

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