Today, GlaxoSmithKline (NYSE: GSK) responded to the recently released Senate Committee on Finance's January 2010 "Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia" (the "Staff Report"). To view GSK's response, visit http://www.gsk.com/media/GSK-White-Paper-Avandia-23-Feb-2010.pdf.
In its response, GSK states that the Staff Report fails to present an accurate, balanced, or complete view of the currently available information on Avandia. The company rejects any allegations of concealing safety information or acting inappropriately on behalf of patients. GSK respectfully disagrees with the Committee's decision to publish a Staff Report with the errors of fact, omission, and inference detailed in this White Paper.
A fair examination of the company's record will show that GSK has been diligent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians and others in a variety of ways.
The following is a summary of GSK's response:
- Among its most glaring omissions, the Staff Report does not include discussion of the final results of either the ADOPT, DREAM, or RECORD studies. ADOPT, DREAM and the interim data for RECORD were evaluated by an independent FDA advisory board in 2007 along with all the information available at that time on Avandia. That FDA advisory board voted 22-1 in favor of keeping Avandia available for patients.
RECORD provides the best, most reliable assessment of Avandia's cardiovascular safety. RECORD was initiated in 2001 and, in consultation with European regulators, was designed to compare cardiovascular outcomes of patients on Avandia added to metformin or sulfonylurea to those on metformin and sulfonylurea. The study was sufficiently powered to confirm its primary hypothesis. It showed that cardiovascular hospitalization or cardiovascular death (which includes heart attack, congestive heart failure, and stroke) was not statistically different between the two groups after an average of 5.5 years of therapy.
- The report also fails to mention multiple other studies (APPROACH, VICTORY, STARR, VADT, ACCORD, BARI 2D) that all corroborate the ischemic cardiovascular safety of Avandia. None of these studies show a statistically significant association between Avandia and heart attack or other ischemic cardiovascular events.
The absence in the Staff Report of any reference to the final results of the ADOPT, DREAM and RECORD studies, as well as other important studies on the ischemic cardiovascular safety of Avandia, leaves the record incomplete and does not serve the interests of physicians or patients who rely on this medicine to help them treat and deal with diabetes.