Dec 6, 2004
Dr. David Graham, the associate director of science at the Food and Drug Administration (FDA) Office of Drug Safety, estimated that between 26,000 and 56,000 patients might have died from taking Vioxx since 1999 when the FDA declared it safe for use.
Perhaps their tombstones should be inscribed with Merck's logo and the FDA's stamp of approval since both Merck, the drug company and producer of Vioxx, and the FDA knew of health problems associated with the drug even before it was approved in 1999.
A recently released internal memo showed that Merck's own scientists knew as early as 1996 that Vioxx would increase the risk of heart problems and stroke. In early 1998, a Merck scientist presented the company with research results explaining the connection: Vioxx reduced the body's own production of an anti-clotting agent, thus leading to the production of potentially life threatening blood clots.
An FDA medical officer pointed out in 1999 that a small medical study found patients taking Vioxx were three times more likely to experience strokes or heart attacks than people taking a placebo, a blank substitute pill.
None of this prevented Merck from seeking approval of Vioxx, nor did it stop the FDA from granting it in 1999.
When, in May 2000, one of Merck's own studies showed that arthritis patients using Vioxx had a much higher risk of heart attacks than those using another painkiller, Naproxen, did Merck stop selling it? No, nor did the FDA make it stop. The FDA simply decided that Vioxx should carry a warning label, and then took another 18 months to come up with the wording for this label.
And it took another three years and more deaths before Merck finally pulled the drug. Promising relief from arthritic, joint and back pain, Vioxx was becoming a big seller. In fact, twenty million people have taken the drug in the U.S. alone since the FDA approved it.
Not only was Vioxx Merck's most profitable seller it came along at the time Merck was about to lose sole patents on several other big-selling and profitable drugs. So Vioxx would prop up what otherwise might have been a tumble in Merck's profits.
Measuring lost profits against lost lives, Merck and the FDA opted for protecting profits.