GlaxoSmithKline pre-broadcast statement: BBC Panorama, 6 September 2010

Issued: London UK

GlaxoSmithKline today issued the following statement in anticipation of the BBC Panorama programme, 'A risk worth taking?' which is scheduled to be aired this evening.

We are concerned that the BBC Panorama programme could alarm patients and their families about the use of Avandia (rosiglitazone) for the treatment of type 2 diabetes. This is a chronic and serious disease that if left untreated can result in serious health problems.

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.

Avandia is currently under review by the European (EMA) and US (FDA) medicines regulatory authorities and GSK acknowledges the significant efforts these independent bodies have made to apply scientific rigour to understanding the benefit-risk profile of Avandia.

We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia. No other diabetes medicine introduced in the last 10 years has such an extensive safety database. The results from this research programme have been given to regulatory authorities worldwide.

Our view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.

Taken together, the data from these types of trials have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes medicines. We continue to believe that Avandia is safe and effective when it is prescribed appropriately.

The company understands that the BBC Panorama programme will feature an audio recording of a meeting between GSK medical and clinical experts and Dr Steve Nissen. This meeting, which was hosted by Dr Nissen, took place on 10^th May 2007. Four GSK scientists met with Dr Nissen to discuss the scientific data on Avandia.

The audio recording of this meeting was made covertly by Dr Nissen. At no stage before or during the meeting was GSK informed that the meeting was being recorded. Selected extracts from this audio recording have already been provided by Dr Nissen to The New York Times newspaper.

In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the "secret tape the drug company would rather you didn't hear."

On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr Nissen, GSK obtained a copy of the audio recording. The company today (6 September) posted the recording to its website www.gsk.com.

The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context.

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.

We have diligently shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.

We remain fully committed to maintaining best practice disclosure of clinical data for all our medicines to serve the interests of patients, physicians and regulators.