The case of Avandia brings up important issues regarding the FDA and the drug approval process. A product of GlaxoSmithKline (GSK), Avandia is used for treatment in type 2 diabetics. Avandia in many cases appears to be a useful treatment. Avandia is an insulin sensitizer that works to moderate levels of glucose in the blood. It has been widely asserted that the drug causes a heightened risk of serious health problems such as stroke and heart disease. The data demonstrating this connection is controversial, with some studies asserting that Avandia increases the risk for heart disease by 43% and for stroke by 27%. GSK continues to manufacture Avandia despite settling on more than 11,500 Avandia lawsuits, which could cost GSK somewhere between $1 billion and $6 billion. In 2009, Avandia sales had declined significantly but still totaled $1.2 billion worldwide.
The FDA’s mission is clear: to protect the safety and public health of U.S. residents through the regulation of food and drug products. However, as exemplified by Avandia, the application of this mission is difficult and wrought with controversy in a high stakes environment which where strong pressures come from powerful pharmaceutical companies. A 2010 Time article uses the Avandia case as evidence that the FDA is a failed institution. The article states that, “Congressional reports revealed that GSK sat on early evidence of the heart risks of its drug, and that the FDA knew of the dangers months before it informed the public.” This type of case raises the question of how much power large conglomerate corporations exert over the regulatory functions of the FDA. We know that one member of the voting panel was a paid GSK spokesperson; we don’t know if other members were also unfairly influenced.
Even within the FDA, opinions have varied, ranging from leaving the drug on the market as is to banning it completely. No such controversy exists within the European Medicines Agency, who voted to ban Avandia in Europe on September 23, 2010. In comparison, the FDA appears divided, slow, and ineffective. Meanwhile, affected consumers continue to file Avandia lawsuits for personal injury and wrongful death.
To say that this is the case of evil corporations versus public health would vastly oversimplify a very complicated issue. Firstly, the dangers are not clear, with different sources report contradicting data. Secondly, there is difficulty calculating whether the increased risks outweigh the benefits that patients receive from the drug. Several prominent medical organizations urge patients currently on Avandia to continue using the drug. This recommendation comes from a belief that the risks of not using the drug are more severe than the potential heightened risk of heart disease and stroke.
The numbers of people filing an Avandia lawsuit will continue to grow. And, hopefully the case of Avandia will spur more investigations into corporate influence on the FDA’s decisions. However, just as we would hope that GSK would carefully test their drugs before releasing them, we should strive to get all of the facts before forming opinions.