© ALEX NABAUMVioxx was on the market for 5 years before manufacturer Merck voluntarily withdrew the arthritis medication in 2004 due to an increased risk of heart attacks and strokes. An estimated 88,000–139,000 Americans had heart attacks while taking Vioxx, and as many as 55,000 died. Soon after, other painkillers in the same class of medicines came under scrutiny, including Bextra, which Pfizer removed from the market in 2005 upon the recommendation of the US Food and Drug Administration (FDA).
Americans cried out for better oversight of approved drugs. Then, in 2007, a cardiologist in Cleveland showed that Avandia, a blockbuster antidiabetic drug, increased the risk of heart attacks. An FDA advisory committee reviewed the evidence and found the claim to be true, but voted to keep Avandia on the market because of its efficacy, while mandating that the drug carry the FDA’s strictest warning label. The cries became louder.
Today, almost a decade since Vioxx was taken off the market and 6 years since Avandia made headlines, the national system for monitoring approved drugs has not gotten any better, critics say—despite the 2007 FDA Amendments Act (FDAAA) that granted the agency more power to oversee drugs once they hit the market.
“I don’t think ...
