Shortly before the FDA approved Vioxx in 1999, drug maker Merck launched a study it hoped would prove that Vioxx was superior to older painkillers, because it caused fewer gastrointestinal problems. Instead, the study would eventually show Vioxx could be deadly, causing heart attacks and strokes.
Five years after Vioxx’s launch, Merck withdrew the drug from the market. By that time, Merck had sold billions of dollars of the drug worldwide. A timeline of Vioxx’s rise and fall:
November 1998: Merck asks the Food and Drug Administration (FDA) for approval of Vioxx, having tested the drug on 5,400 subjects in eight studies.
January 1999: Merck launches the Vioxx Gastrointestinal Outcomes Research study (VIGOR). With more than 8,000 participants, it is the largest study ever done of the drug. Half take Vioxx and the other half take naproxen. The clinical trial is designed to see whether Vioxx is safer for the digestive system than naproxen, an older painkiller.
May 1999: The FDA approves Vioxx, making the drug available by prescription in the United States.
October 1999: First meeting of the VIGOR study’s data and safety monitoring board (DSMB). Study results as of Oct. 1, 1999, show that Vioxx patients have fewer ulcers and less gastrointestinal bleeding than patients taking naproxen. It looks as if the study will be a success for Merck.
November 1999: At the second meeting of the VIGOR safety panel, the discussion focuses on heart problems. As of Nov. 1, 1999, 79 patients out of 4,000 taking Vioxx have had serious heart problems or have died, compared with 41 patients taking naproxen. The minutes of the panel’s November meeting note that “while the trends are disconcerting, the numbers of events are small.” The panel votes to continue the study and to meet again in a month.
December 1999: The safety panel holds its last meeting. It’s told that as of Dec. 1, 1999, the risk of serious heart problems and death among Vioxx patients is twice as high as in the naproxen group.