Avandia was approved by the Food and Drug Administration in 1999 to treat type 2 diabetes and is used by an estimated two million people worldwide. An article published yesterday in the New England Journal of Medicine suggests that Avandia significantly increased the risk of heart attacks and heart-related deaths. The article prompted the FDA to issue a public safety alert advising users of Avandia to consult their doctors about potential cardiovascular risks.
Both the study’s lead author and the editors of the NEJM cautioned that the research method used in the study left the findings open for interpretation. In fact, the FDA reported in its News Release that there are two ongoing randomized studies producing results that contradict the newly published study. Nonetheless, the NEJM study involved nearly 28,000 patients and a review of more than 40 existing clinical studies. The editor in chief of the NEJM, Jeffrey M. Drazen, M.D., said:
We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about the cardiovascular toxicity of this drug.
Not surprisingly, the maker of Avandia, GlaxoSmithKline, issued a news release attacking the NEJM article and defending the drug. What is surprising is that Glaxo and the FDA disclosed yesterday that they had known about the signals of the cardiovascular risks since last August! This disclosure prompted questions in Congress about why doctors and patients had not been informed earlier. If Avandia turns into another Vioxx, Glaxo will have no one to blame but itself. Avandia is Glaxo’s second biggest money maker, and it looks like this might be another example of a drug manufacturer placing profit over patient safety. This approach usually backfires, as evidenced by the 8% drop in Glaxo’s stock price following the publication of the NEJM article.