Healthy Skepticism Library item: 18883
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Huffman M
Utah Sues Maker of Diabetes Drug Avandia
ConsumerAffairs.com 2010 Nov 15
http://www.consumeraffairs.com/news04/2010/11/utah-sues-maker-of-diabetes-drug-avandia.html
Keywords:
GlaxoSmithKline accused of misrepresenting 'wonder drug'
Full text:
Utah has field suit against GlaxoSmithKine (GSK), saying it illegally marketed its drug Avandia as a “wonder drugâ € to fight type 2 diabetes.
Utah Attorney General Mark Shurtleff says the suit was filed because consumers were misled by the sale and promotion of the diabetic medication.
“Our office will continue to pursue drug companies that misrepresent the effectiveness of their drugs for economic gain and at the expense of the citizens of Utah and the State Medicaid program,â € Shurtleff said.
The complaint alleges GSK defrauded Utah out of $7.8 million, which represents how much the State Medicaid Program spent on Avandia between January 1, 2001 and June 30, 2010.
Utah is among the first states to act after the Food and Drug Administration (FDA) recently placed tight restrictions on Avandia use and the Justice Department asked for information about its marketing practices for the drug.
It is alleged that beginning in 1999, GSK misrepresented to the public and the FDA that Avandia would reduce diabetic cardiovascular risks and was better at lowering blood sugars than other established drugs. However, the complaint identifies various studies, including one in the New England Journal of Medicine, that Avandia significantly increased diabetics’ risk of heart attacks and other serious cardiovascular events, as compared to some of the older established and less expensive drugs.
Avandia has been removed by regulators from the European market and the FDA has recently restricted its use in the U.S. to diabetes patients who haven’t responded to other treatment.
More expensive, less effective
“The State Medicaid Program paid significantly more for a drug that in fact was no more effective than traditional drugs that were less expensive,â € said Assistant Attorney General Robert C. Morton, with the Utah Medicaid Fraud Control Unit. “Unlike the less expensive traditional drugs, Avandia exposed Utah Medicaid recipients to greater risks of heart attacks and other cardiac complications.â €
Regulators placed restrictions on Avandia in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia. In taking the action, the FDA said it was seeking to strike the right balance to support clinical care.
States, meanwhile, are investigating to determine if GSK misled health care providers by overstating the benefits and possible uses of the drug. Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.
The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.
Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the new rules will limit use of Avandia significantly.
