GlaxoSmithKline strongly defends its record on Avandia

The following is GlaxoSmithKline’s (NYSE: GSK) response to a press release issued by the US Senate Committee on Finance about Avandia® (rosiglitazone maleate):

The suggestion that GlaxoSmithKline has placed patients at risk and attempted to silence independent investigation of data is absolutely false. Any fair examination of the company’s record will show that GSK has been fully transparent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, scientists, physicians, and the public in the best interests of both patients and scientific debate.

The statistical analysis on which the Committee bases its concern is, by the author’s own admission, limited, while the editorial accompanying the paper states: “the possibility that the findings were due to chance cannot be excluded.”

In contrast, GSK has initiated the most comprehensive and rigorous program of scientific analysis for any oral anti-diabetic medicine on the market today, with experience in over 52,000 patients. The company has initiated:

* Extensive clinical trials, including long-term clinical trials in diabetic patients;
* A prospective, long-term, clinical trial specifically designed to address cardiovascular safety in diabetic patients;
* A proactive, integrated clinical trial analysis of the company’s own collected data; and
* Rigorous monitoring of spontaneously reported adverse events.

These data show that Avandia has a cardiovascular safety profile comparable to other oral anti-diabetic medicines. In addition, independent investigators performed a comprehensive analysis of patients in a US managed care database of more than 33,000 people with diabetes, and showed there was no difference in cardiovascular events among patients taking Avandia-containing regimens versus other oral anti-diabetic medicines.

Over time, the company has actively shared new data on Avandia with the FDA and with regulators worldwide as quickly as scientifically possible. GSK has a strong commitment to providing timely access to its data, which is why the company was one of the first to develop a Clinical Trials Register, on which Avandia data has been posted, and where it is available to any scientific investigator interested in doing their own analysis.

GSK stands firmly behind the safety of Avandia when used appropriately, and will strongly defend its commitment to patient safety and to full transparency of its scientific information. We welcome the opportunity to meet with the Committee and its staff to correct misunderstandings and to clarify the record.