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To: Rambi who wrote (12687)	7/5/2007 7:23:08 PM
From: epicure	Read Replies (1) \| Respond to of 51711

That was so cool you said it twice. Deservedly stressed I think. Free snacks. What a country!

To: Rambi who wrote (12687)	7/6/2007 7:18:15 PM
From: Mephisto	Respond to of 51711

I don't think you find those amenities in American public hospitals.

To: Rambi who wrote (12687)	7/6/2007 7:42:36 PM
From: Karen Lawrence	Respond to of 51711

FDA and Glaxo Share Blame for Avandia Disaster Evelyn Pringle Documents dating back 7 years show the FDA knew about the risks associated with Avandia and did nothing to protect consumers. On May 21, 2007, the New England Journal of Medicine reported a study that found GlaxoSmithKline's diabetes drug Avandia is associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death. The NEJM said it posted the article online ahead of its June 6, 2007 print edition because of its medical importance. Experts point out that the studies analyzed for the NEJM report were not designed to look for heart risks, many were only 24 weeks long, and it may be that higher risks will appear after a longer term of use. Dr David Nathan, chief of diabetes care at Massachusetts General Hospital, who reviewed the paper for the NEJM, told the Associated Press, "This analysis is just scratching the surface of what may be there." Avandia (rosiglitazone) was FDA approved in 1999 for the treatment of type 2 diabetes, a disease that affects between 18 to 20 million Americans. When approved, Glaxo promoted Avandia as being safer than Rezulin, a diabetes drug removed from the market in 2000 after serious cases of liver damage developed in patients taking the drug. Avandia is currently the top selling diabetes drug with total US sales of $2.2 billion in 2006, according to IMS Health, a healthcare tracking information firm. A one-month supply sells for between $90 and $170, the Associated Press reported on May 23, 2007. "More than 6 million people worldwide," the Associated Press reports, "have taken the drug to control blood sugar since it came on the market eight years ago, and about 1 million Americans use it now." The FDA is going to have an extremely tough time wiggling out from under the rug of blame for this regulatory failure. The situation "reflects very badly on the FDA and on Glaxo," Dr Nathan said. "It's the FDA's responsibility to be monitoring this stuff." In an editorial that accompanied the study in the NEJM, Dr Bruce Psaty of the University of Washington and Dr Furberg of Wake Forest University wrote: The drug "represents a major failure of the drug-use and drug-approval processes in the United States." They also state that "the rationale for prescribing rosiglitazone at this time is unclear,” because when the drug was approved its benefits were "at best mixed."