Leo Pharmaceuticals: Dovobet ‘Dear Doctor’ letter implied most patients could be switched from Dovonex (AUTH/2035/8/07)

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Key facts

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Case number	AUTH/2035/8/07
Complainant	Consultant dermatologist
Company	Leo Pharmaceuticals (Leo Pharma)
Product(s)	Dovobet (calcipotriol/betamethasone); Dovonex Ointment (calcipotriol; discontinued); Dovonex Cream (mentioned as option)
Material	Dovobet ‘Dear Doctor’ letter (ref 1008/10488), dated 26 June 2007
Main issue	Implied most patients could be switched/replaced from Dovonex Ointment to Dovobet without clearly stating important differences, including side-effect profile
Audience	Consultant dermatologists, GPs, dermatology/district/practice/prescribing nurses, hospital and retail pharmacists
Breach clauses	7.2 (x2), 7.4, 9.1
No breach clauses	2 (and no breach found regarding discontinuation reference in context)
Complaint received	16 August 2007
Case completed	12 October 2007
Appeal	No appeal
Sanction	Undertaking received

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

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A consultant dermatologist complained about a Leo Pharma letter (ref 1008/10488) dated 26 June 2007 promoting Dovobet (calcipotriol/betamethasone) and referring to discontinuation of Dovonex Ointment (calcipotriol).
The letter stated that because the “clinical usefulness” of Dovonex Ointment had diminished it was no longer supplied in the UK and advised that “for the majority of your patients, Dovobet … can replace Dovonex Ointment”.
The complainant alleged this read as a recommendation to directly switch most psoriasis patients from a non-steroidal vitamin D analogue to a product containing a potent topical corticosteroid, potentially putting patient safety at risk.
The letter had broad circulation (consultant dermatologists, GPs, nurses, hospital and retail pharmacists).
The Panel noted important differences between the products (indication breadth, treatment duration, paediatric use restrictions, and notably the different side-effect profile due to Dovobet containing a potent corticosteroid).

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The Panel ruled the letter implied most patients could be simply switched, without making important differences clear; this was misleading and could not be substantiated.
The Panel ruled it was misleading not to alert readers to the differing side-effect profile/risk-benefit considerations when advocating a switch to a potent steroid-containing product; referring to prescribing information was not sufficient.
The Panel ruled failure to make differences clear meant high standards were not maintained.
No breach of Clause 2 was ruled (the Panel did not consider the material brought discredit upon or reduced confidence in the industry on balance).
The principle of product discontinuation was considered prima facie outside the scope of the Code; however, references to discontinuation within promotional material must comply with the Code. No breach was found regarding the discontinuation reference in this context.

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