Leo Pharma image

Leo exaggerates Picato properties

pharmafile | June 14, 2013 | News story | Medical Communications, Sales and Marketing ABPI, LEO Pharma, PMCPA 

Leo Pharma has been censured by the PMCPA for not maintaining high standards over an advertisement that overreached itself when it extolled the virtues of its Picato gel.

Following a complaint by Almirall that the advert fell foul of the ABPI Code of Practice, the PMCPA decided that the advert breached clause 7.10 (‘promotion must encourage the rational use of a medicine by presenting it objectively and without exaggerating its properties’).

As a result it ruled that Leo had also breached clause 9.1 (‘high standards must be maintained at all times’) and the company did not appeal. The case is to be published in the August 2013 Review.

The advert in question carried the heading: ‘Picato Announcing the arrival of…The revolutionary, shortest duration, patient-applied actinic keratosis treatment.’

Below that claim were two spiral bound pads showing ‘2 DAYS’ and ‘3 DAYS’ along with a picture of a train which appeared to be travelling at high speed.

Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults – but the headline claim only referred to actinic keratosis without noting the licence restriction. 

This meant it seemed the brand could treat any type of actinic keratosis although this is clearly not the case: therefore the PMCPA panel decided that the advert did not encourage rational use.

Clause 7.10 of the Code also says: ‘Exaggerated or all-embracing claims must not be made and superlatives must not be used except for those limited circumstances where they relate to a clear fact about a medicine.’

In a submission, Leo explained that the gel was indeed ‘revolutionary’ because it only has to be applied to the affected area once daily for two or three consecutive days – unlike other treatments which must be applied for 21-90 days. 

Had this been clarified in the advert, it seems likely the PMCPA would have accepted this: but it was not clear that the word ‘revolutionary’ only referred to the ‘shortest duration’ – it could also have been read as referring to the ‘patient-applied actinic keratosis treatment’. 

The train image may also be taken to indicate Picato’s speed of effect, the PMCPA felt – and yet the effectiveness of treatment could not be assessed for eight weeks.

Taking the problems with the advert into account, the panel decided Leo’s standards had slipped below that expected under the Code.

Adam Hill

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