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 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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