Dr. Nissen’s study shows similarities of Vioxx and Avandia
The heart risks of Merck’s painkiller Vioxx led to a crisis for the drugmaker four years ago. The drug was withdrawn, the company’s CEO later resigned, lawsuits proliferated, and the Food and Drug Administration was subjected to much criticism for not knowing of Vioxx’s problems before approving it and letting it go on the market.
Now, another drug is creating similar ripples. The New England Journal of Medicine has published a study that links Avandia, the commonly prescribed diabetes drug, to an elevated risk of heart attack. Both Avandia’s manufacturer, GlaxoSmithKline, and the FDA are hoping to avoid a reprise of the Vioxx debacle.
The study, conducted by Dr. Steven Nissen and his colleagues at the Cleveland Clinic, involved 15,560 patients who took Avandia and 12,283 in a control group. It found 86 heart attacks among those who took Avandia and 72 in the control group. Some 39 people who took the drug died from heart disease, compared with 22 for the control group.
Avandia is a widely used medication, and since diabetics are predisposed to heart disease, anything that further raises their cardiovascular risks is reason for concern. Dr. Nissen began his review of Avandia because two large studies of patients who took it were worrisome. He also decided to look at other data, including studies conducted by the FDA and even the clinical trials found on GSK’s website. Since his meta-analysis was published in the NEJM, doctors, patient, the media and the FDA have paid close attention.