History of Vioxx and its recall by Merck

Several readers have written to ask us about the history of Vioxx and how it was marketed by Merck. So we put our team to dig into the annual reports from 1999 to 2003 and here are our findings.

The title on the cover page of Merck's 1999 annual report (the only year in which Vioxx was featured on the cover of its annual report) declares, "Vioxx: Our biggest, fastest and best launch ever." Inside the report, Merck CEO Raymond Gilmartin boasts, "Vioxx is the fastest growing prescription arthritis medicine in the United States, and, by the end of 1999, Merck had successfully launched Vioxx in nearly 50 nations." A picture shows Elsy Jucker-Bianchi, 79, of Ossingen, Switzerland climbing the steps with her great-grandchildren. Wonder what happened to Ms. Jucker-Bianchi! (Related article: Americans scared after Vioxx recall)

Merck continues to talk about how aggressively it moved to market Vioxx to Americans, "Merck launched Vioxx in the United States last May, more than a month ahead of schedule, thanks largely to efforts by our Regulatory Affairs team in rapidly compiling the 500,000-page application for the U.S. Food and Drug Administration (FDA). Within days of approval, professional sales representatives including members of a specialty sales force fanned out to educate doctors about Vioxx and to provide them with samples." (Related article: Vioxx recall leads to doubts about overall drug safety in the US)

Vioxx was equally aggressively marketed to non-Americans. Merck boasts again, "It was the first drug in its class to be launched in the United Kingdom. Vioxx quickly became the most successful launch in the U.K. pharmaceutical industry...In Switzerland, it soared by its already-launched competitor to achieve market leadership in its class within just 17 weeks. Similar results have been achieved in Sweden, Germany, Puerto Rico and Brazil." (Related article: Vioxx recall makes drug regulatory agencies worldwide more careful)

In 2000, Merck continued its aggressive push for Vioxx and the CEO boasted, "(Vioxx) is already our second largest selling medicine overall. Vioxx is well positioned globally for long-term market leadership." The annual report further talks about Vioxx. "Global sales are running at an annual rate of more than $2 billion...Our drug already accounts for about half of all new COX-2 prescriptions written in the United States..." At that time the VIGOR study was already completed and Merck admitted that the data did not show that Vioxx was as safe as they had been claiming all along, "Although the VIGOR study was a GI outcomes study and was not designed to show differences in cardiovascular effects, significantly fewer heart attacks were observed in patients taking (Aleve) naproxen (0.1 percent) compared to the group taking Vioxx 50mg (0.5 percent) in this study. There was no difference in cardiovascular mortality between the group treated with Vioxx or naproxen." The Food and Drug Administration Arthritis Advisory Committee recommended in February 2001 that the study's results, as well as data on certain cardiovascular events, should be included in the labeling. "The FDA is not obligated to follow the advice of the Advisory Committee," Merck annual report commented.

But 2001 was not a great year for Vioxx and other drugs in the Cox-2 class. Gilmartin wrote, "...the COX-2 class (including Vioxx) experienced lower than expected penetration into the arthritis and analgesics market. This resulted in lower than expected growth for Vioxx, even while it claimed half of new prescriptions in its class. While we remain confident in the continuing worldwide growth potential of Vioxx (prescription trends for the COX-2 class have been recovering over the past several months), the product's 2001 sales did not meet our expectations."

In the 2001 annual report though, Merck talked a little more about the adverse side effects of Vioxx, but still tried to play with words to mislead the reader into believing that Vioxx was a safer drug than over-the-counter painkillers. "Explanations that have been proposed include that Vioxx increased the heart attack rate or naproxen decreased the heart attack rate. Although the underlying reason for the difference has not been established in prospectively designed clinical studies, Merck scientists believe the weight of evidence supports the theory that naproxen decreased the heart attack rate," Merck wrote explaining the results of the VIGOR study. While knowing all this, Merck hired Dorothy Hamill to launch a new direct-to-consumer (DTC) advertising campaign for Vioxx. The company said, "Merck believes DTC advertising is important because it encourages patients to talk to their physicians about their condition and possible treatment options. In 2001, Vioxx achieved $2.6 billion in sales, an increase of 18 percent over 2000." (Related article: Vioxx most dangerous drug in Cox-2 category)

In 2002, Vioxx was no longer a new drug and the company merely mentioned it in its annual report. The same tone is seen in 2003 as Merck continued to experience slower growth and its profitability declined. It will be interesting to see what Merck writes about Vioxx in its 2004 annual report. Vioxx was recalled on September 30, 2004.

Recommended article: Why Merck did not recall Vioxx earlier?