Healthy Skepticism Library item: 20579

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wise J
Novartis found to be in breach of code over drug brochure
BMJ 2013 Jun 20; 346:
http://www.bmj.com/content/346/bmj.f4061

Abstract:

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:

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.