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

Posted by dlife on Wed, Feb 01, 12, 07:01 AM 0 Comment

July 13, 2010 (GlaxoSmithKline) - 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 GSKs 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 an Actos (pioglitazone) -only study on LDL and triglycerides; it was not a study on Avandia (rosiglitazone) and heart attack. The results of this pioglitazone-only study were consistent with the pioglitazone label and thus did not contribute any significant new information. GSK has also examined the clinical effects of LDL increases experienced by some patients receiving rosiglitazone. The data, developed through multiple long-term trials, demonstrates that rosiglitazone treatment is not associated with the progression of atherosclerosis, which is a common cause of myocardial ischemia.
  • 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 GSKs 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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