Glaxo Sued By Maryland AG Over Avandia Risks

So $3 billion may be a large sum of money, but this does not make everything go away. Having paid that much last year to the US federal government to resolve a bushel of civil and criminal charges, some of which pertained to the Avandia diabetes pill, GlaxoSmithKline now faces a fresh lawsuit from the Maryland attorney general, who claims the state overpaid by at least $38 million for purchasing the controvresial drug. In the lawsuit, Glaxo is charged with misleading various state programs, including the State Employee Prescription Drug Plan, the State Retiree Prescription Drug Plan and the Medical Assistance Program, about the virtues of Avandia, which was tied to a higher risk of heart attacks and strokes than previously known after a meta-analysis was released in 2007 by Cleveland Clinic cardiologist Steve Nissen. That analysis, which was published in The New England Journal of Medicine, triggered long-running scrutiny of Avandia clinical trial data and, in the process, highlighted concerns over the extent to which drugmakers make available such information so that independent researhers can verify results. Since then, you may recall, Glaxo has agreed to disclose clinical trial information, including case study reports (read more here). The episode eventually led the feds to charge that, between 2001 and 2007, Glaxo (GSK) failed to include certain safety data about Avandia in reports to the FDA. The missing info included data from post-marketing studies, as well as data ...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Avandia Diabetes GlaxoSmithKline Source Type: blogs