"The FDA," he continued, "has talked a good game about how it's beefed up post-market surveillance over the last two years, but a case like this undermines that claim."
Experts say the new study findings are alarming because two-thirds of the people with type 2 diabetes die of heart problems. In a May 21, 2007 letter to Christopher Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline, Senators Baucus and Grassley wrote, "It is troubling, to say the least, that by taking Avandia, diabetics may be increasing their risk of the very adverse event that they hope to prevent by controlling their blood sugar."
"To make matters worse," they advised, "American taxpayers have spent hundreds of millions of dollars on this drug through the Medicare and Medicaid programs."
"One of the most immediate concerns to us," they told Mr Viehbacher, "are reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia."
"This allegation is very serious and warrants further investigation," the Senators wrote.
According to plaintiffs attorney, Karen Barth Menzies of Baum Hedlund, a law firm that has been litigating drug related cases against Glaxo since 2001, ""The relationship between FDA and the drug industry is disturbing. We've seen internal correspondence between GSK and the FDA that would cause anyone to question the objectivity and regulatory effectiveness of the FDA. Apparently the FDA has failed yet again to protect the public - to the benefit of pharmaceutical industry profits. This failure, and FDA's derogatory attitude towards Dr. Nissen's study, should sound an alarm to all healthcare providers, patients and legislators that the problem is systemic. Patient safety commands serious change in the agency and the industry."
Already, legal conferences are being scheduled to discuss the legal implications of this latest drug safety scandal. Karen Barth Menzies is an invited speaker at an upcoming legal conference regarding Avandia. The conference will include Avandia's background, the science behind the drug, its side effects as well as the FDA's role in regulating Avandia.
Must Read (
Well Said (
News (
Touching (
Funny (
Supported (
Interesting (
Inspiring (
Valuable (
