A report by a team of German scientists led by Dr Bernd Richter, of the Heinrich-Heine University was published last week by medical research evaluation organisation the Cochrane Collaboration.
It went as far as to recommend that ‘if possible, other anti-diabetic medications should be employed’.
GSK has set up a UK and US based crisis communications team. UK head of corporate relations Phil Thomson said the team would ‘question the validity of the data that is being presented and reassuring patients about the product’s safety’.
This has included a rebuttal of the claims that the drug increases the risk of heart attacks and a condemnation of the research techniques used.
The German report is not the first time the drug’s safety has been questioned. A damning report by cardiologist Dr Steve Nissan appeared in the New England Journal of Medicine in May, claimed that the drug increased the risk of heart attacks by 43 per cent.
But the latest report comes on the eve of a decision by the US Food and Drug Administration (FDA) on the future of the drug. The FDA was meeting this week to discuss a range of options including ordering its withdrawal or introducing stricter labels or warnings, following a series of critical medical reports linking the drug to increased risk of heart attacks.
The crisis communications team in the UK is three-strong, headed by Thomson and including directors of media relations Joss Mathieson and Claire Bough. The team in the US is also three-strong, headed by US head of corporate relations Nancy Pekarek and assisted by Cohn & Wolfe.
Avandia was authorised for use in the EU by the European healthcare regulatory body the European Medicines Agency (EMA) in 2000.
The EMA released a statement in May, shortly after the New England Journal of Medicine report, advising patients to continue using the treatment.