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Experts call for Avandia suspension

GSK has been forced to defend criticism of its controversial diabetes drug Avandia from prominent organisations in the healthcare industry

GlaxoSmithKline (GSK) has been forced to defend criticism of its controversial diabetes drug Avandia (rosiglitazone) from prominent organisations in the healthcare industry, including the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the British Medical Journal (BMJ).

Both the agency and the journal have suggested sales of the drug should be suspended following links to an increase in serious cardiovascular events including heart attacks.

The renewed call to halt the use of the controversial drug in the UK comes as the BBC airs Panorama: A Risk Worth Taking? on Monday September 6.  The edition of the documentary series focuses on the health risks associated with Avandia and whether regulation of the drug has been sufficient.

The programme includes news of a unanimous vote by clinicians at the MHRA's advisory body, the Commission on Human Medicines (CHM), in July for Avandia's withdrawal from the UK. This vote was not made public.

The MHRA did however send a letter to healthcare professionals advising the close observation of "current contraindications, warnings and precautions and monitoring requirements, and to consider alternative treatments where appropriate."

The BMJ has also called for the withdrawal of Avandia in a recent article and has questioned the European Medicines Agency's (EMA) initial decision to approve its use in 2000.

Speaking to news agency Reuters, BMJ editor, Dr Fiona Godley said: "The time has now come for this drug to be withdrawn from the market."

Responding to the BMJ article, GSK said in a statement: "GSK has carried out an extensive research programme involving more than 50,000 patients to analyse the safety and benefits of rosiglitazone. No other diabetes medicine introduced in the last 10 years has such an extensive safety database."

"We reject any suggestion that there is a lack of publicly available trial results related to rosiglitazone for independent scientific scrutiny."

A separate response was issued by GSK concerning the BBC documentary, in which the company said: "Patients concerned by the programme should seek advice from their doctor and not stop their medication.

"The company has not seen the programme but denies any suggestions that it has put patients at risk. We consider patient safety a priority."

Specific reference was made to extracts of an audio recording to be featured in the programme. These recordings are of a meeting between four GSK medical and clinical experts and Dr Steve Nissen to discuss data on Avandia.

GSK has said it was not informed by Dr Nissen that he was recording the conversation, with the company taking action to obtain a complete version of the audio recording.

GSK's website has a downloadable version of the full recording.

The company said of the conversation with Dr Nissen: "For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia."

The EMA's Committee for Medicinal Products for Human Use (CHMP) is meeting on Wednesday September 8 to hold further discussions concerning the risks of rosiglitazone-containing medicines including Avandia.

This meeting is being held outside the Committee's usual monthly schedule, to allow it time to prepare for its next scheduled meeting lasting from September 20 to September 23 where the CHMP expects to finalise the review of rosiglitazone.

In the US, two advisory committees to the Food and Drug Administration (FDA) voted in July to recommend Avandia stay on the market despite safety concerns. A final FDA decision on the drug is still to be made.

Panorama: A Risk Worth Taking? is broadcast on BBC One, Monday 6 September at 2030 BST. It will subsequently be available on BBC iPlayer for a limited period.

6th September 2010


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