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GSK responds to JAMA editorial and commentary

Issued:  Tuesday, 23 March 2010, London UK and Research Triangle Park, NC

A commentary and accompanying editorial published today in the Journal of the American Medical Association (JAMA) unjustly challenges the motives of physician scientists seeking to inform diabetes treatment and patient safety and mischaracterizes the RECORD study on rosiglitazone.

•         RECORD is a regulatory commitment study that was run by an independent steering committee, an independent safety monitoring board and a clinical endpoint committee.  The safety monitoring board reviewed all of the data during the course of the study for oversight of patient safety.  Both the interim and final analyses were independently verified at the London School of Hygiene and Tropical Medicine.  The methodology and baseline characteristics and design were published well in advance of any analysis. 

•         While the RECORD study was ongoing, a safety question had been raised by meta-analyses, and an interim analysis was conducted as quickly as possible to gather additional information about the potential risk for patients, not only those in the study, but also those struggling with diabetes treatment in the real world.  Prior to conducting the interim analysis, GSK asked for and obtained the endorsement of the RECORD steering committee.  The allegation that GSK did not obtain this endorsement prior to unblinding the data is simply untrue.

•         The authors of the editorial and commentary state it is important that industry-sponsored studies meet key criteria and be assessed by journals such as JAMA prior to publication to ensure high standards.  The desired criteria include: a detailed reporting of finance, a detailed accounting of roles for sponsors and academics, and clear rationale of design, conduct management and analysis of the study.  RECORD met all these criteria.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

 

Enquiries:
UK Media enquiries:	Philip Thomson	(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:	David Mawdsley	(020) 8047 5564
	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

               

Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.