Vioxx Risks: Could Vioxx Dangers Been Spotted Sooner?
In May 1999 the Food and Drug Administration (FDA) approved Vioxx. The original safety database included approximately 5,000 patients on Vioxx and did not show an increased risk of heart attack, stroke, blood clots, or sudden death.
One year later in June 2000, Merck submitted a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) to the FDA that found an increased risk of Vioxx heart attacks and strokes in patients taking Vioxx compared to patients taking naproxen. After reviewing the VIGOR study results and other available data from controlled clinical trials, the FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new questionable Vioxx-related information.
Fourteen months later in April 2002, the FDA implemented labeling changes to reflect findings from the VIGOR study. These labeling changes included information about the increase of Vioxx heart attack and stroke risks.
Why did it take 22 months to alert the medical community and its patients about life threatening risks for Vioxx induced chest pain, heart attacks, blood clots, stroke, and sudden death?
The problems with Vioxx raise questions about the FDA’s safety review process and the length of time it took Merck to pull Vioxx off the market. The FDA bases its decisions on the drug’s risk-benefit profile and the societal need and desire to take Vioxx. The FDA believes that its actions were appropriate according to their public health mission.
The FDA has come under extreme pressure from the pharmaceutical industry to quickly approve drugs despite the fact that too few patients enrolled in clinical trials or that shorter clinical trials are being held. On the flip side, consumer watchdog groups say highly paid pharmaceutical lobbyists put pressure on the administration to roll out the drug without adequate clinical trial data. Combine the two conflicting opinions and serious problems can lie beneath the surface until drugs like Vioxx are more widely used. Why should the Vioxx-taking public be put at risk so the pharmaceutical companies can profit billions?