Avandia advert hypertension claims ‘misleading’
pharmafile | December 30, 2004 | News story | Sales and Marketing |
Claims that GlaxoSmithKline's diabetes drugs Avandia and Avandamet help to significantly lower blood pressure broke the UK Code of advertising, the industry's watchdog has ruled.
The adverts were investigated in early 2004 following a complaint from a PCT prescribing support unit and have now been published in the latest round-up of cases by the Prescription Medicines Code of Practice Authority.
The PCT prescribing support team unit complained neither of the products' summary of product characteristics (SPCs) mentioned their blood pressure lowering effects, but did in fact mention side-effects likely to cause increased blood pressure.
GSK strongly defended the wording of its adverts, taking the view that its blood pressure lowering claims were not inconsistent with the SPCs and that drawing attention of prescribers to "highly relevant additional pharmacodynamic properties of a productdid not break the rules".
The report notes that GSK argued that by its nature, an SPC "could not act as a repository of all clinical information pertinent to a medicine" and said it would "evidently be impracticable" to apply to update the summary every time a new piece of evidence became available.
GSK says evidence from a number of independent reviews show glitazones reduce elevated blood pressure, an outcome not seen in traditional oral hypoglycaemic agents such as sulphonylureas.
The company also pointed out that the MHRA had recently reviewed the promotion of the glitazone class of medicines, citing a letter which acknowledged possible anti-hypertensive effects of the drugs.
The MHRA letter stated that promotion of secondary effects was permitted as long as they were not given undue prominence relative to the licensed indication.
The Code of Practice Authority panel noted the evidence of Avandia's effect on lowering blood pressure but ruled that the balance of the message in the adverts had given 'undue emphasis' to these claims.
It ruled the adverts had given the impression the products were licensed for the indication, and found them to be 'misleading and inconsistent' with their marketing authorisations and in breach of clauses 3.2 and 7.2 of the Code.
