Vioxx was pulled from the market three years ago amid concerns over its safety. But even now, the painkiller is the subject of endless controversy. The scandal surrounding Vioxx helped to undermine the credibility of the Food & Drug Administration (FDA), and led to calls for a complete overhaul of its drug safety programs. And Merck, the maker of Vioxx, continues to face thousands of lawsuits filed by people who say they suffered serious injuries as a result of Vioxx.
Since it was taken off the market, Vioxx has come to symbolize everything that is wrong with the FDA. In 2004, an FDA study estimated that Vioxx could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.
Since the Vioxx controversy, other FDA approved drugs have been the subject of safety concerns. Most notable of these is Avandia, a popular diabetes drug that was found to have a high risk of heart failure and heart attack. Subsequent investigation found that the FDA had known about Avandia’s heart attack risk as far back as September 2005. However, the agency felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. As a result, the problems with Avandia did not become public knowledge until this past May. During congressional hearings, allegations were also leveled that the FDA had intimidated Avandia safety reviewers into keeping quiet about the drug’s potential problems.
The ensuing outcry over these safety scandals led Congress to pass major FDA reforms this year. These reforms should make the FDA much less dependent on the drug industry for safety information, and give the agency more power to take action against defective drugs. The legislation was signed into law by President Bush just last month.
Merck, the manufacturer of Vioxx, has yet to see the end of its woes related to the defective drug. The company has already spent $1.04 billion on its defense against Vioxx lawsuits. Merck faces up to 59,650 product liability cases, 266 potential class-action lawsuits, one class-action certified in Canada and lawsuits from seven states to recoup what they paid for Vioxx through Medicaid. Starting next year, Merck will face the first Vioxx trials that involve patients who had strokes.