In 2004, we followed “The Vioxx Conundrum” as an example of the context, The Gaming of Nearly Everything. In September of that year, Merck pulled its $2.4 billion-per-year drug off the market after its own research showed the drug doubled the risk of heart attack and stroke. By 2008, Merck had agreed to fund a $4.85 billion settlement over the drug, plus it had spent more than $1.53 billion on legal costs. Merck is now within months of processing, paying or rejecting 10,000 U.S. claims.
GlaxoSmithKline could be facing similar problems. In 2007, at the FDA’s request GlaxoSmithKline agreed to conduct a six-year study of its third best selling drug, Avandia ($2.2 billion in annual revenues) and a rival drug, Actos. The ongoing study, which will involve 16,000 participants, is still enrolling patients. Meanwhile, the Senate Finance Committee concluded a 2-year inquiry on February 20, in which it stated that GlaxoSmithKline knew of possible heart attack risks tied to Avandia years before evidence of a link became public. In the Senate report, FDA researchers are quoted as calling the study “unethical and exploitative” since their agency allowed the trial to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. (Washington Post, 2/21/10; Associated Press, 3/1/10)
What will GlaxoSmithKline end up paying for 83,000 known heart attacks allegedly due to its drug?
Risa Hess
Tags: GlaxoSmithKline, Merck