Novartis found to be in breach of code over drug brochure

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.”