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GSK comments on Avandia controversy

Singapore, Sep 7, 2010: GlaxoSmithKline (GSK), London, UK, in a statement to the public, has said that it continues to work in the best interest of diabetes patients who face this chronic and serious disease in lieu of the Avandia controversy. Patients taking Avandia should speak with their doctor about their treatment, and any questions they may have, regarding their medicine.
Contrary to suggestions within the article produced by the British Medical Journal, GSK stated that it has carried out an extensive research program involving over 50,000 patients, to analyze the safety and benefits of rosiglitazone. No other diabetes medicine introduced in the last 10 years, has had such an extensive safety database.
The company rejected any suggestion that there is a lack of publicly available trial results related to rosiglitazone, for independent scientific scrutiny. They also said that they've shared data relating to the cardiovascular safety of Avandia in a timely and transparent manner, and have made extensive efforts to publish the clinical trial findings in peer review journals, at scientific meetings and via their own clinical trials website.
The company also is fully committed to maintaining best practice disclosure of clinical data for all its medicines to serve the interests of patients, physicians and regulators.
The European and US medicines regulatory authorities are currently reviewing the benefit risk profile of Avandia, based on the totality of the data. GSK acknowledged the efforts of these independent bodies to apply scientific rigor, to enhance understanding of the benefit-risk profile of this medicine, and will continue to work with regulatory authorities worldwide in the best interest of patients.

© BioSpectrum Bureau
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