Avandia Claims to Cost Glaxo Another $90 Mil.

     (CN) – GlaxoSmithKline agreed to spread $90 million across 38 states to settle claims that it fraudulently misrepresented the safety risks of the diabetes drug Avandia.
     One of the claims, filed Thursday by Illinois Attorney General Lisa Madigan, states that Glaxo “misrepresented that Avandia had a positive cholesterol profile, when in fact, defendant did not possess competent and reliable scientific evidence to substantiate the claims,” and that it “misrepresented that Avandia had a cardiovascular benefits, when in fact it does not, and may increase cardiovascular risks.”
     The complaint accuses Glaxo of violating both the Illinois Consumer Fraud Act and the Uniform Deceptive Trade Practices Act.
     Illinois will receive more than $5 million as part of the settlement.
     In a statement about the settlement, Madigan said: “Our investigation demonstrated that GlaxoSmithKline had little regard for the facts or for the health and safety of the patients it targeted with its misleading marketing.”
     The complaint points out that this deceptive marketing is especially troubling in a diabetes drug. Diabetes often causes heart disease and stroke and is the seventh leading cause of death in the United States.
     “Since diabetics already have high cardiovascular risks, it is important that any treatment not increase the risks,” the complaint states.
     The Food and Drug Administration approved Avandia, a tablet drug, in 1999. It is most often used in patients whose Type 2, or adult-onset, diabetes has progressed.
     In addition to the cash, the settlement requires Glaxo to reform its marketing and promotion of diabetes drugs.
     Glaxo must also refrain from making misleading claims about diabetes drugs, making safety claims not supported by significant evidence and promoting drugs before they receive FDA approval.
     The settlement also requires Glaxo to post summaries of all company-sponsored observational studies and clinical trials of diabetes products for eight years.
     The other states that participated in the settlement are Oregon, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.
     In July, Glaxo agreed to plead guilty and pay $3 billion to dispel federal charges, marking the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.

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