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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.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909