Avandia Dangers Underscore Need for Tougher Laws
(Washington, D.C.) Even though the diabetes drug "Avandia" was implicated in an estimated 83,000 heart attacks between 1999 and 2007, the consumer "protection" agency of the federal government - the Food and Drug Administration (FDA) - still allowed the drug to be prescribed and used freely throughout the U.S.; so says a just-released Senate Committee report publicized tonight on national network television newscasts.
According to the Washington Post, Avandia brought in revenues of $2,200,000,000 in 2006 for its manufacturer, pharmaceutical giant GlaxoSmithKline (GSK), making Avandia the company's 3rd-best-selling drug that year.
After reviewing more than one-quarter million pages of documents, the Senate Committee concluded that "GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public..."
Yet, instead of warning patients sufficiently and promptly alerting the FDA of the problems, the Committee found that GSK bosses instead intimidated independent doctors and concentrated on manipulating the findings about Avandia causing increasing risk of cardiovascular events. Said the report, GSK even attempted to minimize the good news about the positive effect - reducing cardiovascular risks - that its rival's pharmaceutical, ACTOS, had demonstrated. (Senate Committee report, @ pp.14-15.)
Outlined in a black box, GSK's website said this about Avandia:
"WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA"
In that warning box, GSK goes on to warn of -
• the need to monitor carefully for heart failure symptoms after Avandia dosage increases;
• its recommendation that symptomatic heart failure patients avoid Avandia; and
• Avandia's relationship to angina or heart attack.





