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[e-drug] BMJ - Novartis found to be in breach of code over drug brochure

E-DRUG: BMJ - Novartis found to be in breach of code over drug brochure
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Novartis found to be in breach of code over drug brochure
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f4061 (Published 21 
June 2013)
Cite this as: BMJ 2013;346:f4061

Jacqui Wise

Novartis has been found to have made several breaches of the drug 
advertising code of practice over a brochure promoting a new drug for 
chronic obstructive pulmonary disease (COPD).1

The Drug and Therapeutics Bulletin made several specific complaints 
about the evidence used and the claims made in a brochure that was sent 
to UK GPs, Evidence Review of Seebri Breezhaler (Glycopyrronium 
Bromide). One of the complaints was that it contained an unsubstantiated 
argument for the treatment of exacerbations of COPD.

The Prescription Medicines Code of Practice Authority upheld all the 
complaints and ruled that Novartis was in breach of the code of 
practice. The authority considered that Novartis's claim that reductions 
in exacerbations could reduce death rates was misleading and could not 
be substantiated.

The authority also ruled that the presentation of the data in a table on 
glycopyrronium and exacerbations was not complete enough to allow the 
reader to appreciate its statistical significance and was misleading.

The editor in chief of the Drug and Therapeutics Bulletin, James Cave, 
said, 'For 50 years we have argued successfully to remove or restrict 
medicines and curb excessive promotional claims by pharmaceutical companies.

'This latest victory is particularly important because it has put a stop 
to the increasingly used claim that, by preventing exacerbations, drugs 
can reduce mortality. Unfortunately this has yet to be demonstrated by 
any drug used in the treatment of COPD.'

Notes
Cite this as: BMJ 2013;346:f4061

References
Prescription Medicines Code of Practice Authority. AUTH/2588/3/13: the 
Drug and Therapeutics Bulletin v Novartis. 
www.pmcpa.org.uk/cases/Pages/2588.aspx.

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