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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.
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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:
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 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.
GSK stands behind the safety of Avandia. Contrary to recent media reports, the FDA has not called for withdrawal of Avandia, and in a recent statement, has advised that "Patients should continue taking rosiglitazone unless told by their healthcare professional to stop." GSK welcomes the opportunity for an independent and scientific evaluation of the collective safety of rosiglitazone at the upcoming FDA advisory committee in July. In agreement with statements made recently by the Endocrine Society and the FDA, the safety of Avandia should be judged in light of all available scientific data with emphasis on long-term prospective studies.
The assessment of the safety of Avandia is continuing now with a clinical trial called TIDE, which was undertaken at the direction of the FDA, to include a randomized comparison of Avandia and Actos in addition to the comparison of Avandia to placebo. The protocol for conducting the study was developed with and approved by FDA, and will provide the only large-scale, head-to-head comparison of the two medicines. TIDE also has been approved by an independent review board and appropriate safety boards that are responsible for monitoring and assessing the safety of the trial in Type 2 diabetes patients.
GSK is committed to transparency and has been diligent in reporting the results of clinical trials, observational studies and meta-analyses on the company's website, as well as reporting them to regulatory agencies in a timely fashion.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit us.gsk.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
-- 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.
SOURCE GlaxoSmithKline
