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Issued: Monday 6th September 2010, London UK

GlaxoSmithKline Pre-Broadcast Statement


BBC Panorama – 6th September 2010

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 10th May 2007. Four GSK scientists met with Dr Nissen to
discuss the scientific data on Avandia.

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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.” 1

On Friday 3rd September 2010, following the issuing of a subpoena (legal request) to Dr Nissen,
GSK obtained a copy of the audio recording.  The company today (6th 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.

GlaxoSmithKline Enquiries:
UK Media enquiries: David Mawdsley (020) 8047 5502
Claire Brough (020) 8047 5502
Stephen Rea (020) 8047 5502
Alexandra Harrison (020) 8047 5502
Jo Revill (020) 8047 5502

US Media enquiries: Nancy Pekarek (919) 483 2839


Mary Anne Rhyne (919) 483 2839
Kevin Colgan (919) 483 2839
Sarah Alspach (919) 483 2839

European Analyst/Investor enquiries: Sally Ferguson (020) 8047 5543


Gary Davies (020) 8047 5503

US Analyst/ Investor enquiries: Tom Curry (215) 751 5419


Jen Hill Baxter (215) 751 7002

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