GlaxoSmithKline (GSK) responds to Senate Finance Committee letter of 12 July to FDA

The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation. They include drafts and other documents taken out of context, which therefore are incomplete and misleading. The documents do not offer new clinically relevant scientific information, and do not provide the full extent of GSK’s studies and evaluation of Avandia. GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website.

Issued: Tuesday 13 July 2010, London UK

The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation. They include drafts and other documents taken out of context, which therefore are incomplete and misleading. The documents do not offer new clinically relevant scientific information, and do not provide the full extent of GSK’s studies and evaluation of Avandia. GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website.

GSK has responded to all requests from the Senate Finance Committee since its inquiry began in 2007. In this instance, GSK provided the Committee with the documents and requested that the Committee honor the court's protective order to guard against parties in ongoing litigation trying to circumvent valid protective orders. Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading.

In response to specific allegations of the Senate Finance Committee:

- Study 175 was a small, short term study with Actos (pioglitazone) and placebo designed to examine the effect of Actos on lipids. There were no data on outcomes such as heart attacks in this study and assertion that this small study informed GSK's views about heart attacks associated with Avandia (rosiglitazone) use is unfounded. The findings of this study were no different from the available published data on lipids that were known and were included in the Actos label at that time. The effect of Avandia on lipids was discussed at the 1999 Advisory Committee Meeting and was included in the label at the time of approval. GSK has also examined the impact of Avandia on the progression of atherosclerosis, a common cause of myocardial ischemia, and has not seen a deleterious effect. Furthermore, long-term effects have been studied in ADOPT and RECORD; these studies have not shown any effect on cardiovascular mortality.

- With respect to the two other studies referenced by the Committee, GSK submitted the data from these studies (079 and 096) to the FDA in 1999. The study data is also publicly available on GSK’s Clinical Study Register.

- GSK follows established authorship practices modelled after the International Committee of Medical Journal Editors (ICMJE) guidelines, which require "Substantial contributions" by authors as well as final approval of the article before publication. The article referenced by SFC, Effect of Rosiglitazone on Nontraditional Markets of Cardiovascular Disease with Type 2 Diabetes Mellitus, was authored by Dr. Steven Haffner, and reflects his substantial input and his views. This article was not part of the Case Study Publication for Peer Review programme, which was discontinued for rosiglitazone in 2004 and produced only two articles.

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