Editorial: Regulators falling down on the job

Monday, Nov. 8, 2004 | 9 a.m.

Last week a highly respected British medical journal issued a damning report that found the Food and Drug Administration had approved the painkiller Vioxx despite knowing about its potential dangers to the public. The medical journal Lancet reported that the FDA and Merck, the maker of Vioxx, knew as early as 2000 that studies had revealed that those who took the drug were much more likely to suffer a heart attack. It wasn't until a month ago, however, that Merck took Vioxx off the market. An editorial published by The Lancet contended that Vioxx's approval by regulators and its attendant popularity led to "public health catastrophes," resulting in more than 27,000 heart attacks and sudden deaths.

Merck and the FDA both denied that they did anything wrong and asserted that they moved quickly once the problems were known. But one of the first doctors to point out the problems associated with Vioxx, Dr. Eric Topol, a cardiologist at the renowned Cleveland Clinic, had a much different take. "It is unquestionable that the risks of the drug were known some time ago and not duly acknowledged, and this study is the best yet to prove that," Topol told The New York Times. What's particularly alarming are allegations that the FDA suppressed warnings from its own drug-safety reviews about the hazards associated with Vioxx, a drug that's been used by an estimated 20 million patients.

The revelations about Vioxx come right on the heels of the FDA's failure to make sure our nation had enough flu shot dosages this year. On Friday the FDA announced it was asking the Institute of Medicine, a nonprofit group funded mostly by the federal government, to evaluate the agency's drug-monitoring program. This is a necessary first step, but Congress should vigorously continue its own investigation into these serious problems at the FDA.