Key Principles 1: Material must be factual, accurate and balanced
As for all materials, information must be factual, accurate and presented in a balanced way (refer to module 2 for more information and examples illustrating these basic principles). Materials must fairly reflect the relevant facts and the views of AstraZeneca as a whole. The registration status of any product mentioned should be made clear.
For licensed products the licensed indication should be quoted exactly as it appears in the SmPC and should not be altered in any way. Missing out important caveats within a licensed indication is a common error – this can be seen as misleading or even promoting outside of the licensed indication.
The clinical relevance of information should be made clear – if the clinical relevance has not been established make sure it has not been implied.
Consider this example
Nexium press release
In 2010 AstraZeneca issued a press release for Nexium (a proton pump inhibitor) to announce a new indication for the product –the prevention of gastric/duodenal ulcer rebleeding. The press release referred to use of Nexium in patients taking aspirin and encouraged consumers to talk to their doctors about reducing risk of peptic ulcers if they were taking aspirin. At the time the product was not licensed for reducing risk of ulcers in aspirin users.
The Australian Monitoring Committee made a complaint that this was promoting an unlicensed indication to the public. In addition, when the case was investigated, it was discovered that the new licensed indication (prevention of rebleeding) had not been quoted accurately. This licence only applied following therapeutic endoscopy and this important information had been left out.
AZ was found to be in breach of the Australian Code for misquoting the new indication, off licence promotion and inaccurate information in the press release, and was fined $75,000.
