Cleveland Clinic study draws parallels between Vioxx and Avandia
Concerns about the heart risks of Vioxx sparked a crisis for the drugmaker Merck in 2003. That led to the withdrawal of the drug in September 2004, the eventual resignation of the CEO and widespread criticism of the Food and Drug Administration for not learning of the drug’s problems before it was approved and marketed.
Now, Vioxx may have a competitor of sorts. A study recently published in the New England Journal of Medicine has linked the most commonly prescribed diabetes drug, Avandia, to a heightened risk of heart attack. Both the FDA and Avandia’s manufacturer, GlaxoSmithKline, are trying to avoid a repeat of the Vioxx debacle.
The study involved 15,560 patients who took Avandia and 12,283 in a control group. The lead author of the study, Dr. Steven Nissen of the Cleveland Clinic, found 86 heart attacks in the group taking Avandia, compared with 72 in the control group. In addition, 39 people who took the drug compared with 22 for the control group died from heart disease. The numbers may seem small, but these results came from short-term studies. And since more than 65% of diabetics eventually die of heart disease, those few could become thousands when seen over the course of patients’ lifetimes.
Avandia is widely used, and because diabetics are so vulnerable to heart disease, anything that raises their risk of heart attacks is reason for further study. Dr. Nissen began studying Avandia because two of the largest studies of patients taking the drug caused him concern. The results were not very statistically significant, but he decided to look at other data, including studies conducted by the FDA and even the clinical-trials registry on GSK’s website. His meta-analysis was soon published in the NEJM.