Key Topic 1: Encourage Rational Prescribing – Unsubstantiated Claims
All product claims must be capable of substantiation (see key topic 2 in this module for more information about standards of evidence).
Ideally claims should be supported by the approved product information. However this is not always possible and other supportive material may be needed.
When considering supportive data from the literature or from internal ‘data on file’ remember that claims must reflect the full and current body of evidence.
This means that if you can find one paper to support your claim, but there are 20 others that do not support it, you are unlikely to be able to substantiate it!
Be careful when dealing with emerging scientific opinion – balance is most important in these situations.
Sometimes cases will hinge on subtleties of language as the following example demonstrates.
Example
In Australia a health professional complained about an advertisement for Valdoxan published in ‘Australian Doctor’ by Servier.
The complaint centred on the claim:
“An effective anti-depressant recommended first line in 2013 clinical guidelines”.
The claim was referenced to the approved product information for Valdoxan and a published paper.
The complainant alleged that neither the first reference, the Product Information, nor the second reference, an article by Malhi et al (2013) were clinical guidelines.
The claim therefore could not be adequately substantiated and was false and misleading.
The Committee noted that the published paper was a literature review of evidence available through PubMed and MEDLINE, which built upon the authors’ previously published clinical practice recommendations for bipolar disorder. The study aims were stated to be “to provide clinically relevant, evidence-based recommendations for an individualized formulation for pharmacotherapeutic management”
The Committee decided that a literature review is not generally understood as being clinical guidelines. Clinical Guidelines are usually developed through consultation and discussion between relevant clinicians and published by a relevant medical college or society.
The Committee considered that the claim was misleading because it implied that the Malhi et al (2013) literature review was a clinical guideline that had been generally accepted and endorsed by clinical experts or a medical college, whereas the study was a published literature review. The majority of the Committee also considered that the claim could not be adequately substantiated because the Malhi et al 2013 paper did not necessarily reflect the full body of evidence. This view was upheld on Appeal and Servier were fined $100,000
