Advert exaggerated Plavix benefits
pharmafile | January 4, 2005 | News story | Medical Communications |Â Â Â
An advert for anti-clotting drug Plavix has been found in breach of advertising rules because of exaggerated claims of efficacy over standard treatment aspirin.
The advert was investigated by the Prescription Medicines Code of Practice Authority following a complaint from a PCT's lead prescribing support pharmacist, who argued its claims went beyond the currently available evidence.
The pharmacist cited the CAPRIE study in which patients with a history of heart attack, ischaemic stroke or peripheral arterial disease (PAD), were randomised to aspirin or Plavix.
Results showed that Plavix significantly reduced the risk of further events compared to aspirin in those who had suffered a PAD but not in those who had suffered other events.
The complainant said the advert suggested that Plavix had demonstrated superiority to aspirin in all cases.
Co-marketers Bristol-Myers Squibb and Sanofi-Aventis defended the advert, saying it was consistent with conclusions drawn from the CAPRIE study as well as the product summary of product characteristics (SPC) and claimed the complainant had misinterpreted the advert.
While the complainant agreed that the advert was in keeping with the SPC and accurately reflected the primary study group of CAPRIE, he said it invited an inappropriate interpretation of the product data.
The Code of Practice Authority panel reached a similar conclusion, and ruled that the advert implied that any patient who presented with a heart attack or with a stroke or PAD would have a better outcome on Plavix compared to aspirin.
It considered that the advert was misleading in this regard and upheld the panel ruling of breaches of Clauses 7.2 and 7.4 of the Code.
