Non promotional communications should not include content that might be perceived as promoting a medicine
This area is not clear cut and is often a matter of judgment, and so following the case law is important. The potential consequences of getting this judgement wrong are being found guilty of off label promotion, disguised promotion and promotion to the general public. This can lead to damage to AZ’s reputation, as well as various sanctions (which can include fines and imprisonment). Most importantly it can lead to patient harm.
Non promotional communications should be accurate, fair and balanced. Be careful in particular about statements made about products in this regard. Consider the general tone as well as the presentation. Broad or ‘sweeping’ statements should generally be avoided as they are difficult to support. In addition you should avoid ‘extreme’ examples and quotes in materials. For example “In this trial, product X was superior to product Y” is a broad statement. It would be preferable to quote the specific endpoint for which superiority was demonstrated and to present the relevant statistics.
Consider these examples:
Product claims for superiority in a press release
In the UK GlaxoSmithKline complained about press materials issued by Sanofi Pasteur MSD and activities undertaken on behalf of the company following the Department of Health’s announcement to use Cervarix (GlaxoSmithKline’s human papillomavirus (HPV) vaccine) for the national HPV immunisation programme for the prevention of cervical cancer, instead of Sanofi Pasteur MSD’s vaccine, Gardasil. The press release stated
‘We regret that school girls in the UK, unlike most of their peers in Western Europe, the USA, Australia, New Zealand and Canada, will not benefit from the unmatched cervical cancer protection and additional benefits provided by the World’s leading HPV vaccine, Gardasil’.
Which of the following do you agree with?
- ‘World’s leading HPV vaccine’ could be considered a promotional statement
- ‘unmatched cervical cancer protection’ is a claim for superiority
- If this statement can be substantiated it is not promotional
- ‘Unmatched cervical cancer protection’ would only be approvable with head to head data showing superiority
Ruling
The Panel considered that, within the context of the press release, the claim implied that Gardasil had been unequivocally proven to be clinically superior to Cervarix with regard to cervical cancer protection. The SPCs for Gardasil and Cervarix reported high percentage efficacy rates for both products. There was no head-to-head data, however, and so it was not known if any of the differences between the products, based on the figures published in their respective SPCs, were clinically or statistically significant. The Panel considered that the claim for unmatched cervical cancer protection was misleading, unsubstantiated and exaggerated. Breaches of the regulations were ruled.
Promotion to the general public
In Australia the Monitoring Committee alleged that various activities conducted by Roche media relations personnel constituted promotion of its product Gazyva (for leukaemia) to the general public.
On investigation the Australian Medicines Committee found that the media reports in question, which were numerous and widely published, were overly optimistic about the likely outcomes from treatment with Gazyva and may have the effect of encouraging people with leukaemia to seek treatment with the product.
In defence Roche stated that through interactions with an experienced health journalist, who was part of a syndicated news network, and a television journalist, the resultant story was distributed much more broadly than they had originally intended.
The Committee noted that an email from Roche to the journalist offered a “strong patient case study” for a patient who would have died without the treatment. The email referred to the patient now being able to ride long distances on a mountain bike, which was reported in the media articles.
The Committee considered that the materials raised unfounded hopes of successful treatment, and that the materials promoted Gazyva to the general public. Roche had to pay a fine of $100,000.
