The story of GlaxoSmithKline’s once blockbuster diabetes drug Avandia is unfortunately not a unique one. Avandia, used as a glucose regulator for patients with type 2 diabetes, was been fraught with contention and debate for the past four years at least. Allegations that the drug heightens diabetics’ risk of heart attack and heart failure have been cast from independent researchers, physicians, public injury Avandia lawyers, the American Diabetes Association, consumer groups, the Senate Finance Committee and even researchers within GlaxoSmithKline. However, despite a strong move from the European Union in September of 2010 to ban the drug from European markets, Avandia remains available in the U.S. today. The Food and Drug Administration (FDA) cites a “balancing act” required to weigh the potential positive and negative impacts of a drug. “Products get approval because we see that the benefits outweigh the risks. Then we try to adjust as we go along,” said FDA spokeswoman Karen Riley.
Every year, the number of type 2 diabetics rises in the United States. Unlike type 1 diabetes, which is generally thought to be genetic, type 2 or “adult onset” diabetes is more often associated with obesity. Heart attack is among several serious health risks faced by diabetic patients over the long term. Avandia was once one of the most popular drugs on the market prescribed to these patients; as recently as 2009, over two million prescriptions were filled for the drug. In light of the health risks associated with Avandia, has the FDA been prudent in striking a careful balance between benefit and risk? Or are Avandia lawyers correct when they argue that both GlaxoSmithKline and the FDA were negligent in properly warning the public about the increased risk of heart attack caused by this drug?
For the record, the FDA has released multiple warnings about Avandia’s health implications in the past four years. In November of 2007, following an investigation that showed that Avandia can increase a patient’s risk of heart attack by 43%, the FDA issued a “black box warning”, advising consumers of the drug’s serious side effects. Avandia prescriptions plummeted in the following months but millions continued to take the drug. A few years of debate followed: in 2008, the Senate Finance Committee issued a report alleging that GlaxoSmithKline had suppressed the outcomes of research conducted since 2000, shortly after Avandia was approved by the FDA. Finally, in September of 2010, the FDA voted to issue a restriction on the drug. Today, Avandia remains available in the U.S., but only to patients willing to sign a consent form stating they understand the risks of the drug.
The balancing act cited by the FDA spokeswoman is meant to weigh the potential health benefits against their risks. Upon its initial approval in the U.S., Avandia was recognized for its use in maintaining healthy glucose levels in the blood. Yet evidence today points to the fact that inadequate testing – short-term tests that could never have been expected to reveal long-term problems – were the source of this data. To date, over 13,000 Avandia lawsuits related to personal injury and wrongful death have been brought against GlaxoSmithKline. The role of the FDA is to ensure the careful testing and regulation of pharmaceuticals in order to protect American consumers. In the case of Avandia, it has failed.