Despite GSK’s efforts to refute Dr. Nissen’s conclusions, they have since been confirmed by other studies. In a paper published in Journal of the American Medical association (JAMA), scientists from Wake Forest University School of Medicine analyzed four clinical trials of Avandia lasting at least one year. They found that patients taking Avandia had a 42% greater risk of having a heart attack than those in the control group.  Similarly, studies by a group of German scientists, from the Düsseldorf’s Heinrich-Heine University, concluded that Avandia could actually worsen complications of diabetes. 

Black Box Warning

On July 30, 2007, the FDA held a Joint Meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety Management Advisory Committee to discuss the issue. Committee members decided that available data support the conclusion that Avandia increases the risk of cardiac ischemia (heart attack) in type 2 diabetic patients. While they ultimately voted against removal of Avandia from the market, they emphasized the need for strengthening the label language (Black Box), more studies by the manufacturer, and educating doctors and patients regarding the risks of Avandia. Black Box is the highest form of warning that FDA issues in regard to a drug. In November 2007 FDA ordered GSK to add a black box warning to Avandia packaging.
Conclusion
  Jeanne Whalen, The Wall Street Journal Online. Glaxo Diabetes Drug Is Dealt fresh Blows. September 2007. Available at: http://online.wsj.com/article/SB118953808407824064.html?mod=European-Business-News (Last accessed on May 21, 2008)

  Study pooled data from 18 past trials involving 8,000 patients. From Reuters, July 18, 2007 Available at: www.reuters.com/article/health-SP/idUSL1764491620070718?pagenumber=1.

Cardiovascular disease is the number one cause of morbidity and mortality in diabetic patients. While lowering a diabetic person’s blood sugar level is a desirable outcome, any diabetes medicine is ultimately prescribed for reducing the risk of diabetic complications such as cardiovascular disease and heart attacks. A drug such as Avandia, that would itself increase the chances of those complications, poses an entirely unacceptable risk to the safety and wellbeing of diabetic patients. It is unconscionable for a drug company to knowingly market and promote such drug.

GSK was aware of all the dangers that Avandia posed to diabetic patients. But in a cold-blooded cost/benefit analysis, it chose to ignore and conceal them. By hiding what it knew would damage the commercial prospects of Avandia, GSK recklessly placed the lives of those treated with Avandia in a danger that they should not have been exposed to. GSK’s conduct was simply unconscionable.